Rethinking novelty in patent law

Duke Law Journal

Volumn 60, Issue 4, 2011, Pages 919-976

  Seymore, Sean B ^a  

^a VANDERBILT UNIVERSITY LAW SCHOOL   (United States)

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EID: 78851472042     PISSN: 00127086     EISSN: None     Source Type: Journal    
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References (392)

1. See Kewanee Oil Co. v. Bicron Corp., 416 U.S. 470, 481 (1974) (explaining that the information disclosed in the patent adds to the public storehouse of knowledge); Brenner v. Manson, 383 U.S. 519, 533 (1966) ("It is true, of course, that one of the purposes of the patent system is to encourage dissemination of information concerning discoveries and inventions."); Graham v. John Deere Co., 383 U.S. 1, 9 (1966) (describing a patent as "a reward, an inducement, to bring forth new knowledge"); Pennock v. Dialogue, 27 U.S. (2 Pet.) 1, 19 (1829) (recognizing that the patent system seeks to promote the progress of the useful arts and to reward inventors); Blanchard v. Sprague, 3 F. Cas. 648, 650 (C.C.D. Mass. 1839) (No. 1518) ("Patents for inventions are... a just reward [for ingenuity], and... highly beneficial to the public, not only by holding out suitable encouragements to genius and talents and enterprise; but as ultimately securing to the whole community great advantages from the free communication of [knowledge], which may be most important to all the great interests of society....").
2. See infra notes 8-9 and accompanying text.
3. E.g., Patent Reform Act of 2009, H.R. 1260, 111th Cong. (2009) (as introduced by Rep. Conyers, Mar. 3, 2009), 155 CONG. REC. H2923 (daily ed. Mar. 3, 2009); Patent Reform Act of 2009, S. 515, 111th Cong. (2009) (as introduced by Sen. Leahy, Mar. 3, 2009), 155 CONG. REC. S2691, S2706-16 (daily ed. Mar. 3, 2009); Patent Reform Act of 2007, H.R. 1908, 110th Cong. (2007) (as passed by House, Sept. 7, 2007), 153 CONG. REC. H10,307 (daily ed. Sept. 7, 2007); Patent Reform Act of 2007, S. 1145, 110th Cong. (2007) (as introduced by Sen. Leahy, Apr. 18, 2007), 153 CONG. REC. S4675, S4685-92 (daily ed. Apr. 18, 2007).
4. See, e.g., U.S. PATENT & TRADEMARK OFFICE, 2010-2015 STRATEGIC PLAN 10-25 (2010), available at http://www.uspto.gov/about/stratplan/USPTO_2010-2015_Strategic_Plan.pdf (describing several initiatives that will improve examination timelines and patent quality).
5. Press Release, U.S. Patent & Trademark Office, USPTO Will Begin Study of Patent Examiners' Production Goals (Oct. 4, 2007), available at http://www.uspto.gov/news/pr/2007/07-42.jsp (predicting that the study will lead to changes in the Patent Office that will "motivate employees, improve [the] work environment, and enhance the quality and efficiency of the patent examination process").
6. See ADAM B. JAFFE & JOSH LERNER, INNOVATION AND ITS DISCONTENTS 98-107 (2004) (exploring trends in the Federal Circuit toward strengthening patentees' rights).
7. William M. Landes & Richard A. Posner, An Empirical Analysis of the Patent Court, 71 U. CHI. L. REV. 111, 128 (2004) (concluding that the "pro-patent leanings" of the Federal Circuit have "had a significant effect on patent activity").
8. See infra notes 8-9 and accompanying text.
9. The conditions for patentability are found in Title 35 of the United States Code. In short, the claimed invention must be useful, novel, nonobvious, and directed to patentable subject matter. 35 U.S.C. §§ 101-103 (2006). In addition, § 112, ¶ 1, requires that the application adequately describe, enable, and set forth the best mode of carrying out the invention; and § 112, ¶ 2, requires that the application conclude with claims that delineate the invention with particularity.
10. See Bilski v. Kappos, 130 S. Ct. 3218, 3231 (2010) (holding that claims relating to a method of hedging risks are unpatentable).
11. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415 (2007) (rejecting the Federal Circuit's rigid test for nonobviousness due to its inconsistency with the "expansive and flexible" approach set forth in Supreme Court precedent).
12. "Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter... may obtain a patent...." 35 U.S.C. § 101 (emphasis added).
13. Kimberly-Clark Corp. v. Johnson & Johnson, 745 F.2d 1437, 1453 (Fed. Cir. 1984) (citing Graham v. John Deere Co., 383 U.S. 1, 6 (1966)).
14. See 35 U.S.C. § 102 (defining the documents and activities that can serve as prior art).
15. HERBERT F. SCHWARTZ, PATENT LAW AND PRACTICE 18 (3d ed. 2001).
16. Prior art is also used to determine whether an invention is obvious. See 35 U.S.C. § 103(a) (providing that an invention is not patentable "if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains"). For a discussion of obviousness and its relationship to novelty, see infra notes 104 and 170.
17. Prior art provisions fall into two main categories: (1) the novelty provisions of §§ 102(a), (e), and (g), which depend on the invention date; and (2) the loss-of-right provisions of § 102(b), which depend on the applicant's filing date.
18. See 2 R. CARL MOY, MOY'S WALKER ON PATENTS § 8:1 (4th ed. 2009) (explaining § 102 of the Patent Act).
19. A patent claim must define "the subject matter which the applicant regards as his invention." 35 U.S.C. § 112, ¶ 2. A claim element further limits the breadth of the claim.
20. 1 DONALD S. CHISUM, CHISUM ON PATENTS, at Gl-3 (2009).
21. For an illustration, see infra note 19 and accompanying text.
22. In re Skvorecz, 580 F.3d 1262, 1266 (Fed. Cir. 2009); Richardson v. Suzuki Motor Co., 868 F.2d 1226, 1236 (Fed. Cir. 1989) ("The identical invention must be shown in as complete detail as is contained in the patent claim."); see also Structural Rubber Prods. Co. v. Park Rubber Co., 749 F.2d 707, 716 (Fed. Cir. 1984) (explaining that another reference or knowledge in the art cannot supply missing elements).
23. Trintec Indus., Inc. v. Top-U.S.A. Corp., 295 F.3d 1292, 1296 (Fed. Cir. 2002) (noting the "strict identity" test for novelty); see also Jamesbury Corp. v. Litton Indus. Prods., Inc., 756 F.2d 1556, 1560 (Fed. Cir. 1985) (explaining that "a prior art disclosure which is only 'substantially the same' as the claimed invention" is insufficient to defeat novelty).
24. In this hypothetical, titanium and nickel are claim elements.
25. Amgen Inc. v. Hoechst Marion Roussel, Inc., 457 F.3d 1293, 1306 (Fed. Cir. 2006) ("In order to anticipate, a prior art reference must not only disclose all of the limitations of the claimed invention, but also be enabled."); Elan Pharm., Inc. v. Mayo Found. for Med. Educ. & Research, 346 F.3d 1051, 1054 (Fed. Cir. 2003) ("To serve as an anticipating reference, the reference must enable that which it is asserted to anticipate.").
26. The PHOSITA is a hypothetical construct of patent law akin to the reasonably prudent person in torts. See Panduit Corp. v. Dennison Mfg. Co., 810 F.2d 1561, 1566 (Fed. Cir. 1987) (explaining that a PHOSITA is "not unlike the 'reasonable man' and other ghosts in the law"). Factors relevant to constructing the PHOSITA in a particular technical field include "(1) the educational level of the inventor; (2) type of problems encountered in the art; (3) prior art solutions to those problems; (4) rapidity with which innovations are made; (5) sophistication of the technology; and (6) educational level of active workers in the field." Envtl. Designs, Ltd. v. Union Oil Co., 713 F.2d 693, 696 (Fed. Cir. 1983).
27. Impax Labs., Inc. v. Aventis Pharm., Inc., 545 F.3d 1312, 1314 (Fed. Cir. 2008). For a discussion of what constitutes undue experimentation, see infra Part I.B.2.
28. See W.L. Gore & Assocs., Inc. v. Garlock, Inc., 721 F.2d 1540, 1554 (Fed. Cir. 1983) ("Anticipation requires the disclosure in a single prior art reference of each element of the claim under consideration."); see also Verdegaal Bros. v. Union Oil Co. of Cal., 814 F.2d 628, 631 (Fed. Cir. 1987) ("A claim is anticipated only if each and every element as set forth in the claim is found, either expressly or inherently described, in a single prior art reference."). "In deciding the issue of anticipation, the trier of fact must identify the elements of the claims, determine their meaning..., and identify corresponding elements disclosed in the allegedly anticipating reference." Lindemann Maschinenfabrik GMBH v. Am. Hoist & Derrick Co., 730 F.2d 1452, 1458 (Fed. Cir. 1984) (citing Kalman v. Kimberly-Clark Corp., 713 F.2d 760, 771 (Fed. Cir. 1983), overruled by SRI Int'l v. Matsushita Elec. Corp. of Am., 775 F.2d 1107 (Fed. Cir. 1985) (en banc); SSIH Equip. S.A. v. U.S. Int'l Trade Comm'n, 718 F.2d 365, 377 (Fed. Cir. 1983)).
29. Oakley, Inc. v. Sunglass Hut Int'l, 316 F.3d 1331, 1339 (Fed. Cir. 2003).
30. Though § 102(b) is technically not a novelty provision, "[i]t is clearly established that novelty is lacking. .. when the [§ 102(b)] prior art product or process is identical to that of the inventor's product or process.".
31. Akzo N.V. v. U.S. Int'l Trade Comm'n, 808 F.2d 1471, 1479 (Fed. Cir. 1986). As a general matter, patent applicants aggressively seek to limit the universe of prior art that can be asserted against them during examination. The easiest way to accomplish this is to show that a particular reference cannot serve as prior art because of its publication date. For example, an applicant facing a lack-of-novelty rejection based on a journal article published the day after the applicant's filing date can simply identify the date discrepancy and compel the Patent Office to remove the reference and withdraw the rejection. This is true even if the reference discloses an identical paper clip made with titanium and nickel. The analysis is simple and objective because § 102 determines when references become available as prior art. Nonetheless, applicants have an incentive to ensure that the examiner considers all potentially patent-defeating prior art. See Jurgens v. McKasy, 927 F.2d 1552, 1558 (Fed. Cir. 1991) (explaining that an accused infringer may invalidate a patent more easily if the examiner never considered the asserted prior art).
32. It is often forgotten that the patent document serves several key roles in the patent system. Most prominently, the claims establish the boundaries of the patentee's right to exclude, 35 U.S.C. § 112, ¶ 2 (2006), which expires twenty years from the earliest effective filing date, id. § 154(a)(2). But in addition, the disclosure (the written description and the drawings) of a patent or published patent application can serve as prior art. Id. § 102(a), (b), (e). A patent is effective as prior art as of its filing date and remains so forever (just like a book, a magazine, or any other printed publication). See id. § 102(e)(2) (providing that an invention is not patentable if it is described in "a patent granted on an application for patent by another filed in the United States before the invention by the applicant for patent"); In re Giacomini, 612 F.3d 1380, 1385 (Fed. Cir. 2010) (explaining that § 102(e) "codified the history of treating the disclosure of a U.S. patent as prior art as of the filing date of the earliest U.S. application to which the patent is entitled" (emphasis and internal quotation marks omitted)).
33. For a discussion of why patentees might disclose subject matter but not claim it, see infra notes 124-29, 230-35 and accompanying text.
34. In the words of Judge Learned Hand, If the earlier disclosure offers no more than a starting point for further experiments, if its teaching will sometimes succeed and sometimes fail, if it does not inform the [PHOSITA how to make] the new invention, it has not correspondingly enriched the store of common knowledge, and it is not an anticipation. Dewey & Almy Chem. Co. v. Mimex Co., 124 F.2d 986, 989 (2d Cir. 1942).
35. See infra Part II.A. Documentary sources that may serve as prior art include patents and scientific journal articles.
36. Regarding the latter category, the Federal Circuit has not decided whether nonpatent references are entitled to a presumption of enablement. See Amgen Inc. v. Hoechst Marion Roussel, Inc., 314 F.3d 1313, 1355 n.22 (Fed. Cir. 2003) ("We note that by logical extension, our reasoning here might also apply to [nonpatent] prior art printed publications as well, but as Sugimoto is a patent we need not and do not so decide today." (emphasis added)).
37. See infra Part II.A.2.
38. Scholarship that addresses enablement in the prior art context is limited.
39. See, e.g., Donald S. Chisum, Anticipation, Enablement and Obviousness: An Eternal Golden Braid, 15 AIPLA Q.J. 57, 63 (1987) ("A reference that was not enabling upon its publication can become enabling and therefore an anticipation at a later time when additional prior art becomes available-showing, for example, a method of making the disclosed invention.").
40. Timothy R. Holbrook, Possession in Patent Law, 59 SMU L. REV. 123, 171-73 (2006) (arguing that the Federal Circuit's "motivation to combine" doctrine incorporates an enablement standard into the obviousness determination).
41. Janice M. Mueller & Donald S. Chisum, Enabling Patent Law's Inherent Anticipation Doctrine, 45 HOUS. L. REV. 1101, 1131-54 (2008) (arguing that courts should apply a heightened enablement standard when making inherent anticipation determinations).
42. Alan W. White, The Novelty-Destroying Disclosure: Some Recent Decisions, 12 EUR. INTELL. PROP. REV. 315, 316-19 (1990) (exploring British cases that address enablement based on prior disclosures).
43. See infra Part I.B.2.
44. See infra notes 93-94 and accompanying text.
45. David S. Wainwright, Patenting Around Nuisance Prior Art, 81 J. PAT. & TRADEMARK OFF. SOC'Y 221, 221-22 (1999).
46. For a further discussion of the tactic of disclosing subject matter to deliberately thwart a subsequent inventor's claim, see infra notes 124-29.
47. JAMES BESSEN & MICHAEL J. MEURER, PATENT FAILURE: HOW JUDGES, BUREAUCRATS, AND LAWYERS PUT INNOVATORS AT RISK 109 (2008).
48. The researchers define "value" as the private value of the relevant patent, which derives from the right to exclude. Id. at 97. This value "is measured relative to the alternative means an innovator has for profiting from her invention," including trade secrecy and profits on complementary goods. Id. at 98. Unlike most other industries, the pharmaceutical industry views patents as the most effective means of profiting from inventions.
49. See OLIVER GASSMANN, GERRIT REEPMEYER & MAXIMILIAN VON ZEDTWITZ, LEADING PHARMACEUTICAL INNOVATION: TRENDS AND DRIVERS FOR GROWTH IN THE PHARMACEUTICAL INDUSTRY 133-34 (2d ed. 2008) ("[Patent] protection is crucial in the pharmaceutical industry as otherwise nobody would invest in expensive and long-term drug development.").
50. See also Edwin Mansfield, Patents and Innovation: An Empirical Study, 32 MGMT. SCI. 173, 175 tbl.1 (1986) (reporting that 65 percent of products from the pharmaceutical industry would not have been brought to market without patent protection, which contrasts with considerably lower numbers for products from other industries).
51. Indeed, "it is well known that pharmaceutical companies generally refuse to develop new drugs unless they have strong patent protection over them.".
52. Benjamin N. Roin, Unpatentable Drugs and the Standards of Patentability, 87 TEX. L. REV. 503, 513 (2009).
53. The payoff is important because pharmaceutical companies need to recoup their research and development investments.
54. See Jonathan M. Barnett, Private Protection of Patentable Goods, 25 CARDOZO L. REV. 1251, 1279 (2004) (observing that it is easier to detect and show infringement in discrete technologies).
55. Richard C. Levin, Alin K. Klevorick, Richard R. Nelson & Sidney G. Winter, Appropriating the Returns from Industrial Research and Development, 1987 BROOKINGS PAPERS ON ECON. ACTIVITY 783, 798 (arguing that patents are particularly effective in the chemical arts because relatively clear standards can be applied to assess validity and to defend against infringement).
56. See also Wesley M. Cohen, Richard R. Nelson & John P. Walsh, Protecting Their Intellectual Assets: Appropriability Conditions and Why U.S. Manufacturing Firms Patent (or Not) 18-20 (Nat'l Bureau of Econ. Research, Working Paper No. 7552, 2000), available at http://www.krannert.purdue.edu/faculty/smartin/courses/590/NBER7552.pdf (exploring cross-industry differences in patenting).
57. In preparing the claims, a savvy drafter often includes a broad claim encompassing a large number-frequently millions-of individual compounds, which serves as a "net" to ensnare everything using the basic concept of the patentee.
58. See HAROLD C. WEGNER, PATENT LAW IN BIOTECHNOLOGY CHEMICALS & PHARMACEUTICALS § 87, at 114 (2d ed. 1994) ("Claims of varying scope should be provided to take advantage of the multiple claim system. A broad 'claim 1' is fine as a net to try to capture everyone using the basic concept of the patentee." (citation omitted)).
59. 60, or one followed by sixty zeroes) chemical compounds. Id. cols. 133-34. Given that a pharmaceutical patent application is often filed at an early stage of research and development when end results or uses remain uncertain, the resulting patent is like an expensive lottery ticket with the hoped-for payoff being the substantial revenue generated by at least one claimed molecule.
60. Jonathan A. Barney, A Study of Patent Mortality Rates: Using Statistical Survival Analysis to Rate and Value Patent Assets, 30 AIPLA Q.J. 317, 328 n.30 (2002) (using a lottery analogy).
61. Kimberly A. Moore, Worthless Patents, 20 BERKELEY TECH. L.J. 1521, 1548 (2005) (same).
62. Dan L. Burk & Mark A. Lemley, Policy Levers in Patent Law, 89 VA. L. REV. 1575, 1616-17 (2003) (explaining that pharmaceutical patents must be broad enough to prevent invent-arounds).
63. In addition to the possibility of infringement, the unpredictable nature of chemistry hinders the development of successful invent-arounds because "even a minute change to a chemical molecule results in an entirely non-substitutable product.".
64. The pharmaceutical industry defines a blockbuster drug as one that generates at least $1 billion in annual revenue.
65. RONALD J. VOGEL, PHARMACEUTICAL ECONOMICS AND PUBLIC POLICY 25 (2007).
66. This payoff is important because pharmaceutical companies need to recoup their research and development investments.
67. Many pharmaceutical companies rely on a few blockbuster drugs to recoup their investment in innovation and to cover the costs of failed products.
68. FED. TRADE COMM'N, TO PROMOTE INNOVATION: THE PROPER BALANCE OF COMPETITION AND PATENT LAW AND POLICY ch. 3, at 5 (2003).
69. A pharmaceutical company may screen hundreds of thousands of chemical compounds as likely candidates for development, but for "every 10,000 compounds that are evaluated in animal studies, 10 will make it to human clinical trials in order to get 1 compound on the market.".
70. RICHARD B. SILVERMAN, THE ORGANIC CHEMISTRY OF DRUG DESIGN AND DRUG ACTION 8 (2d ed. 2004).
71. In addition, bringing a new drug to market can take twelve to fifteen years and can cost over $800 million.
72. See also Christopher P. Adams & Van V. Brantner, Estimating the Cost of New Drug Development: Is It Really $802 Million?, 25 HEALTH AFF. 420, 424 (2006) (estimating a total cost of $868 million per approved drug).
73. Joseph A. DiMasi, Ronald W. Hansen & Henry G. Grabowski, The Price of Innovation: New Estimates of Drug Development Costs, 22 J. HEALTH ECON. 151, 166 (2003) (estimating the total research and development cost per drug as $802 million).
74. To appreciate the amount of revenue that a blockbuster drug can generate, consider the cholesterol-lowering drug Lipitor-the best-selling drug of all time-which generated over $13.6 billion in revenue for Pfizer in 2006.
75. See also Matthew Herper & Peter Kang, The World's Ten Best-Selling Drugs, FORBES.COM (Mar. 27, 2006, 6:00 AM ET), http://www.forbes.com/2006/03/21/pfizer-merck-amgen-cx_mh_pk_0321topdrugs.html (revealing that Lipitor's annual sales are more than twice as high as its closest competitor).
76. The Lipitor patent expires in June 2011. See U.S. Patent No. RE40,667 (filed Jan. 16, 2007) (reissue patent); U.S. Patent No. 5,273,995 (filed Feb. 26, 1991) (original patent).
77. See also Susan Decker, Pfizer Wins New Lipitor Patent Expiring in June 2011 (Update2), BLOOMBERG (Jan. 6, 2009, 4:46 PM EST), http://www.bloomberg.com/apps/news?sid=aNSygEPe7QWw&pid=newsarchive (discussing the reissue of Pfizer's patent on Lipitor's key ingredient after the company modified "inconsistent language" that an appellate court had found rendered the patent invalid).
78. See STUART O. SCHWEITZER, PHARMACEUTICAL ECONOMICS AND POLICY 51 (2d ed. 2007) ("[Biotechnology firms that] are able to generate revenue... typically reinvest in their products (and in follow-on products in the pipeline) in hopes of discovering yet another new drug, perhaps a spin-off of the earlier one.").
79. See infra Part III.B.4.
80. This is a common scenario because examiners in the Patent Office are familiar with patents and have easy access to them. Thus, most prior art rejections are likely to involve patent documents.
81. See John R. Allison & Mark A. Lemley, The Growing Complexity of the United States Patent System, 82 B.U.L. REV. 77, 101-02 (2002) (presenting empirical findings on references to prior art).
82. See also John R. Allison & Mark A. Lemley, Who's Patenting What? An Empirical Exploration of Patent Prosecution, 53 VAND. L. REV. 2099, 2120 (2000) ("The predominance of U.S. patents [as cited prior art] may... reflect the limitations of the [Patent Office] systems for searching: the [Patent Office] is much more likely to find documents that it itself has generated.").
83. This Article does not explore scenarios in which the inventor's own prior activities or disclosure can serve as novelty- defeating prior art, although such scenarios can be problematic, particularly in the academic and drug-discovery contexts.
84. Sean B. Seymore, The "Printed Publication" Bar After Klopfenstein: Has the Federal Circuit Changed the Way Professors Should Talk About Science?, 40 AKRON L. REV. 493, 495 (2007) ("Klopfenstein is particularly important in the realm of academic science because it suggests that under certain circumstances a run-of-the-mill research talk can become a § 102(b) 'printed publication' and trigger the one-year clock.").
85. See generally Sean B. Seymore, Heightened Enablement in the Unpredictable Arts, 56 UCLA L. REV. 127 (2008) [hereinafter Seymore, Heightened Enablement] (proposing a new approach for examining patent applications in unpredictable technologies which, by requiring applicants to disclose actual experimental results, resolves a striking incongruity between patent law and the experimental sciences).
86. Sean B. Seymore, Serendipity, 88 N.C.L. REV. 185 (2009) [hereinafter Seymore, Serendipity] (arguing that although accidental discoveries pervade science, inventors who invent by accident can be unjustly deprived of patents because such discoveries do not mesh with the substantive law of invention).
87. Sean B. Seymore, The Teaching Function of Patents, 85 NOTRE DAME L. REV. 621 (2010) [hereinafter Seymore, Teaching Function] (proposing a disclosure regime that would allow patents to compete with other forms of technical literature as a source of substantive technical information).
88. The courts refer to chemistry, biotechnology, and related experimental fields as "unpredictable" because skilled artisans in these fields often cannot predict whether a reaction protocol that works for one embodiment will work for others. Cedarapids, Inc. v. Nordberg, Inc., No. 95-1529, 1997 WL 452801, at *2 (Fed. Cir. Aug. 11, 1997) (explaining that in the chemical arts, "a slight variation... can yield an unpredictable result or may not work at all"). On the other hand, applied technologies like electrical and mechanical engineering are often regarded as "predictable" arts because they are rooted in well-defined, predictable factors. In re Vaeck, 947 F.2d 488, 496 (Fed. Cir. 1991). But enablement depends on the facts in a given case because, for example, a mechanical device can have unpredictable features. See In re Bowen, 492 F.2d 859, 861-62 (C.C.P.A. 1974) (criticizing the dichotomy and advocating an alternative classification).
89. And Sean B. Seymore, The Enablement Pendulum Swings Back, 6 NW. J. TECH. & INTELL. PROP. 278, 282-84 (2008).
90. The U.S. Court of Customs and Patent Appeals (C.C.P.A.) was a predecessor to the Federal Circuit. The Federal Courts Improvement Act of 1982 abolished the C.C.P.A. Federal Courts Improvement Act of 1982, Pub. L. No. 97-164, 96 Stat. 25 (codified as amended in scattered sections of 28 U.S.C.). Soon after its creation, the Federal Circuit adopted the C.C.P.A. decisional law as binding precedent. South Corp. v. United States, 690 F.2d 1368, 1370 (Fed. Cir. 1982) (en banc).
91. See Bonito Boats, Inc. v. Thunder Craft Boats, Inc., 489 U.S. 141, 147 (1989) (noting that Thomas Jefferson, the "driving force behind early federal patent policy," believed that "a grant of patent rights in an idea already disclosed to the public [i]s akin to an ex post facto law, 'obstruct[ing] others in the use of what they possessed before'".
92. (Quoting Letter from Thomas Jefferson to Isaac McPherson (Aug. 13, 1813), in 13 THE WRITINGS OF THOMAS JEFFERSON 326, 327 (Andrew A. Lipscomb & Albert Ellery Bergh eds., 1903))).
93. Graham v. John Deere Co., 383 U.S. 1, 5-6 (1966) (explaining that it would be unconstitutional for Congress to authorize the issuance of patents that would remove existing knowledge from the public domain).
94. Max Stul Oppenheimer, In Vento Scribere: The Intersection of Cyberspace and Patent Law, 51 FLA. L. REV. 229, 236-42 (1999) (exploring the constitutional basis and statutory background for prohibiting the granting of patents that would remove technology from the public domain).
95. 1 WILLIAM C. ROBINSON, THE LAW OF PATENTS FOR USEFUL INVENTIONS 305 (Boston, Little, Brown & Co. 1890).
96. GEORGE TICKNOR CURTIS, A TREATISE ON THE LAW OF PATENTS FOR USEFUL INVENTIONS IN THE UNITED STATES § 292 (Boston, Little, Brown & Co. 2d ed. 1854) (footnote omitted).
97. Cf. Rebecca S. Eisenberg, Analyze This: A Law and Economics Agenda for the Patent System, 53 VAND. L. REV. 2081, 2088 (2000) ("Granting patents on technologies that are not new would impose the social costs of monopolies without the countervailing benefits of promoting development and introduction of welfare-enhancing inventions.").
98. See United States v. Dubilier Condenser Corp., 289 U.S. 178, 186 (1933) ("An inventor deprives the public of nothing which it enjoyed before his discovery, but gives something of value to the community by adding to the sum of human knowledge.").
99. Bonito Boats, 489 U.S. at 148. Therefore, the logic behind the novelty requirement "is fairly straightforward.... [because if] information is already in the public domain when the 'inventor' seeks to patent it[,] society has no need to grant a patent to get this information.".
100. Robert P. Merges, Uncertainty and the Standard of Patentability, 7 HIGH TECH. L.J. 1, 12-13 (1992).
101. As the late Judge Giles S. Rich once wrote about knowledge already present in the public domain, "Society, speaking through Congress and the courts, has said 'thou shalt not take it away.'" Kimberly-Clark Corp. v. Johnson & Johnson, 745 F.2d 1437, 1453-54 (Fed. Cir. 1984).
102. Anticipation occurs if the prior art discloses what the applicant seeks to claim.
103. In other words, the prior art reference must disclose the subject matter in sufficient detail to enable a PHOSITA to make it without undue experimentation.
104. The requirement that an anticipatory reference contain an enabling disclosure can be traced back to Seymour v. Osborne, 78 U.S. (11 Wall.) 516 (1870). In that case, an accused infringer attempted to use a foreign publication to invalidate the patent-at-issue. Id. at 554. Finding the publication's disclosure inadequate, the Supreme Court stated, Patented inventions cannot be superseded by the mere introduction of [the reference], though of prior date, unless the description... contain[s]... a substantial representation of the patented improvement, in such full, clear, and exact terms as to enable any person skilled in the art or science to which it appertains, to make, construct, and practice the invention to the same practical extent as they would be enabled to do if the information was derived from a prior patent. Mere vague and general representations will not support such a defence.... Id. at 555; cf. Cohn v. U.S. Corset Co., 93 U.S. 366, 370 (1876) ("It must be admitted that, unless the earlier [reference] does exhibit the later patented invention in such a full and intelligible manner as to enable persons skilled in the art to which the invention is related to comprehend it without assistance from the patent, or to make it, or repeat the process claimed, it is insufficient to invalidate the patent."). In support of its holding, the Seymour Court cited the Curtis treatise, 78 U.S. (11 Wall.) at 555 n.*, which states that the description [in the allegedly anticipatory reference] must be such as to give the public the means of knowledge, or, in other words, must of itself enable the public to practise the invention. It is not necessary that the invention should have been reduced to practice, but, unless the description would enable the public, without further invention, to put the thing in practice, it cannot be said that a knowledge of that thing is in the possession of the public.
105. See Spectra-Physics, Inc. v. Coherent, Inc., 827 F.2d 1524, 1532 (Fed. Cir. 1987) ("Enablement looks to placing the subject matter of the claims generally in the possession of the public.").
106. 35 U.S.C. § 112 (2006).
107. The written description is the part of the patent (or patent application) in which the patentee discloses the invention.
108. The statutory disclosure requirement has four parts, which appear in the first and second paragraphs of § 112: The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention. The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention. 35 U.S.C. § 112, ¶¶ 1-2 (emphases added). Although the term "undue experimentation" does not appear in the statute, "it is well established that enablement requires that the [written description] teach those in the art to make and use the invention without undue experimentation." In re Wands, 858 F.2d 731, 737 (Fed. Cir. 1988).
109. The scope of the claims must "be less than or equal to the scope of the enablement." Nat'l Recovery Techs., Inc. v. Magnetic Separation Sys., Inc., 166 F.3d 1190, 1196 (Fed. Cir. 1999). The scope of enablement "is that which is disclosed in the [written description] plus the scope of what would be known to [a PHOSITA] without undue experimentation.".
110. F. SCOTT KIEFF, PAULINE NEWMAN, HERBERT F. SCHWARTZ & HENRY E. SMITH, PRINCIPLES OF PATENT LAW 413 (4th ed. 2008).
111. Verizon Servs. Corp. v. Cox Fibernet Va., Inc., 602 F.3d 1325, 1337 (Fed. Cir. 2010) ("The standard for what constitutes proper enablement of a prior art reference for purposes of anticipation under section 102... differs from the enablement standard under section 112." (quoting Rasmusson v. SmithKline Beecham Corp., 413 F.3d 1318, 1325 (Fed. Cir. 2005))). "Enablement" does not appear anywhere within the text of § 102. Thus, the doctrine is the result of a "judicially imposed limitation" on § 102 that the description of the subject matter in the reference must be an enabling description. In re LeGrice, 301 F.2d 929, 939 (C.C.P.A. 1962).
112. In re Gleave, 560 F.3d 1331, 1335 (Fed. Cir. 2009) (citing Rasmusson, 413 F.3d at 1326). In an earlier case, Judge Rich provided a statutory basis for the distinction, noting that § 112 provides that the written description "must enable [the PHOSITA] to 'use' the invention whereas § 102 makes no such requirement as to an anticipatory disclosure." In re Hafner, 410 F.2d 1403, 1405 (C.C.P.A. 1969). Thus, the "double standard" is "implicitly[,] if not explicitly, required by law.".
113. Schering Corp. v. Geneva Pharm., Inc., 339 F.3d 1373, 1381 (Fed. Cir. 2003).
114. See infra note 219.
115. See Vas-Cath Inc. v. Mahurkar, 935 F.2d 1555, 1562 (Fed. Cir. 1991) (recognizing the distinction); In re Lukach, 442 F.2d 967, 970 (C.C.P.A. 1971) (same).
116. The patent statute is essentially technology-neutral on its face, although several commentators argue that it is technology-specific in application.
117. See DAN L. BURK & MARK A. LEMLEY, THE PATENT CRISIS AND HOW THE COURTS CAN SOLVE IT 59-65 (2009) (describing how the courts treat industries differently).
118. William A. Drennan, The Patented Loophole: How Should Congress Respond to This Judicial Invention?, 59 FLA. L. REV. 229, 323-28 (2007) (same).
119. Congress added a technology-specific provision to the nonobviousness section of the statute in 1995. Act of Nov. 1, 1995, Pub. L. No. 104-41, § 1, 109 Stat. 351, 351 (codified as amended at 35 U.S.C. § 103 (2006)) (addressing biotechnology patent processes). Interestingly, technological distinctions are prohibited by the Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement, which states that patent rights shall be "enjoyable without discrimination as to... the field of technology.".
120. Agreement on Trade-Related Aspects of Intellectual Property Rights art. 27.1, Apr. 15, 1994, Marrakesh Agreement Establishing the World Trade Organization, Annex 1C, art. 27.1, 108 Stat. 4809, 869 U.N.T.S. 299, available at http://www.wto.org/english/docs_e/legal_e/27-trips.pdf.
121. Relevant considerations include the nature of the invention, the breadth of the claims, the level of predictability of the art, the quantity of experimentation necessary, the presence or absence of working examples, the amount of direction presented, the prior art, and the relative skill of those in the art. In re Wands, 858 F.2d 731, 737 (Fed. Cir. 1988); see also Amgen, Inc. v. Chugai Pharm. Co., 927 F.2d 1200, 1213 (Fed. Cir. 1991) (explaining that the Wands factors are illustrative and not mandatory). For cases applying the Wands factors in the anticipatory-enablement context, see Impax Labs., Inc. v. Aventis Pharm. Inc., 545 F.3d 1312, 1314-15 (Fed. Cir. 2008); Amgen Inc. v. Hoechst Marion Roussel, Inc., 457 F.3d 1293, 1306-07 (Fed. Cir. 2006).
122. For instance, consider again U.S. Patent No. 5,422,351 (filed June 21, 1991).
123. 60, or one followed by sixty zeroes) chemical compounds, the patentee only provided working examples for thirty-nine of them. '351 Patent cols. 7-133.
124. See Schering Corp. v. Geneva Pharm., Inc., 339 F.3d 1373, 1380 (Fed. Cir. 2003) (finding secret tests conducted before the critical date to be irrelevant); see also In re Donohue, 766 F.2d 531, 533 (Fed. Cir. 1985) (sustaining an anticipation rejection for a primary reference disclosing a compound and other references disclosing sufficient information to make that compound). This accords with the lack of express requirement in the Patent Act that an applicant physically reduce an invention to practice before obtaining a patent. See Pfaff v. Wells Elecs., Inc., 525 U.S. 55, 60-61 (1998) (interpreting the statute).
125. See In re Paulsen, 30 F.3d 1475, 1480 (Fed. Cir. 1994) ("[A] prior art reference must be 'considered together with the knowledge of one of ordinary skill in the pertinent art.'" (quoting In re Samour, 571 F.2d 559, 562 (C.C.P.A. 1978))); see also In re LeGrice, 301 F.2d 929, 939 (C.C.P.A. 1962) (explaining that the proper test is whether the PHOSITA "could take the description of the invention in the printed publication and combine it with his own knowledge of the particular art and from this combination be put in possession of the invention on which a patent is sought").
126. Paulsen, 30 F.3d at 1480 (quoting DeGeorge v. Bernier, 768 F.2d 1318, 1323 (Fed. Cir. 1985)).
127. In the unpredictable arts, a PHOSITA typically must engage in trial and error to figure out what works and what does not.
128. Karen S. Canady, The Wright Enabling Disclosure for Biotechnology Patents, 69 WASH. L. REV. 455, 458 (1994) (presenting a biotechnology example).
129. "In view of the rapid advances in science," however, it may be that what is "unpredictable at one point in time may become predictable at a later time." Enzo Biochem, Inc. v. Calgene, Inc., 188 F.3d 1362, 1374 n.10 (Fed. Cir. 1999). This helps explain why enablement is a shifting, unstable doctrine.
130. See In re Vaeck, 947 F.2d 488, 496 (Fed. Cir. 1991) (noting that the requisite level of disclosure for an invention involving a "predictable" factor such as a mechanical or electrical element is less than that required for the unpredictable arts).
131. Nonetheless, elucidating the PHOSITA's knowledge is a fact-specific inquiry.
132. The unpredictable-predictable dichotomy thus is not always dispositive in resolving the gap-filling question.
133. See infra note 96 and accompanying text.
134. See Advanced Display Sys., Inc. v. Kent State Univ., 212 F.3d 1272, 1282 (Fed. Cir. 2000) ("[A]nticipation requires that the four corners of a single, prior art document describe every element of the claimed invention....").
135. One commentator argues that the Federal Circuit's broadening of the "four corners" definition of anticipation has led to conflicts with other patent law doctrines.
136. See Robin Feldman, Rethinking Rights in Biospace, 79 S. CAL. L. REV. 1, 29-39 (2005).
137. See Scripps Clinic & Research Found. v. Genentech, Inc., 927 F.2d 1565, 1576 (Fed. Cir. 1991) (explaining that the role of the additional reference is not "to fill gaps" in the asserted prior art document), abrogated on other grounds by Abbott Labs v. Sandoz, Inc., 566 F.3d 1282 (Fed. Cir. 2009); Studiengesellschaft Kohle, M.B.H. v. Dart Indus., Inc., 726 F.2d 724, 727 (Fed. Cir. 1984) (affirming the district court's findings on anticipation because the accused infringer sought to use the additional references not to interpret or shed light on the prior art reference, but to impermissibly supplement its teachings).
138. For a discussion of lack of nonobviousness as an alternative basis for unpatentability, see infra note 104.
139. See Scripps, 927 F.2d at 1576 ("It is sometimes appropriate to consider extrinsic evidence to explain the disclosure of a reference."); see also In re Baxter Travenol Labs., 952 F.2d 388, 390 (Fed. Cir. 1991) ("[E]xtrinsic evidence may be considered when it is used to explain, but not expand, the meaning of a reference.").
140. See infra Part II.B.
141. See infra Part II.
142. Courts undertake a similar analysis. See Mehl/Biophile Int'l Corp. v. Milgraum, 8 F. Supp. 2d 434, 443-44 (D.N.J. 1998) (articulating the three steps), aff'd, 192 F.3d 1362 (Fed. Cir. 1999).
143. See Trintec Indus., Inc. v. Top-U.S.A. Corp., 295 F.3d 1292, 1294 (Fed. Cir. 2002) ("[T]he anticipation inquiry first demands a proper claim construction."). At the prosecution stage, the examiner must give claim terms the broadest reasonable interpretation a PHOSITA would give them while simultaneously conferring an interpretation consistent with the applicant's written description. In re Morris, 127 F.3d 1048, 1054 (Fed. Cir. 1997).
144. 4 by structure or chemical name ("nickel tetracarbonyl"), then strict identity is met because the prior art teaches each and every element of the subject matter (a nickel atom surrounded by four carbonyl groups).
145. See, e.g., Hybritech, Inc. v. Monoclonal Antibodies, Inc., 802 F.2d 1367, 1379 (Fed. Cir. 1986) ("It is axiomatic that for prior art to anticipate under § 102 it has to meet every element of the claimed invention....").
146. Akzo N.V. v. U.S. Int'l Trade Comm'n, 808 F.2d 1471, 1479 (Fed. Cir. 1986) (citing In re Brown, 329 F.2d 1006, 1011 (C.C.P.A. 1964)).
147. Impax Labs., Inc. v. Aventis Pharm. Inc., 545 F.3d 1312, 1315 (Fed. Cir. 2008).
148. For appeals from the Patent Office, the Federal Circuit reviews the factual underpinnings for substantial evidence. In re Gartside, 203 F.3d 1305, 1316 (Fed. Cir. 2000). Appellate courts review lower courts' factual findings in bench trials for clear error. Impax Labs., 545 F.3d at 1315.
149. In re Hyatt, 211 F.3d 1367, 1371 (Fed. Cir. 2000) (citing Bischoff v. Wethered, 76 U.S. (9 Wall.) 812, 814-15 (1869)).
150. The C.C.P.A. was a predecessor to the Federal Circuit.
151. The framework took shape soon after the C.C.P.A.'s adoption of the possession standard for anticipatory enablement. See In re Sasse, 629 F.2d 675, 681-82 (C.C.P.A. 1980) (explaining that anticipatory-enablement issues are governed by a burden-shifting regime); In re Wilder, 429 F.2d 447, 450-52 (C.C.P.A. 1970) (outlining the burden-shifting process for the anticipatory-enablement inquiry); In re Jacobs, 318 F.2d 743, 745 (C.C.P.A. 1963) (stating that the appellants can prevail only if they carry the burden of proof).
152. Wilder, 429 F.2d at 450 (quoting 35 U.S.C. § 102 (2006)) (internal quotation marks omitted); see also Ex parte Thorne, No. 95-4440, 1999 WL 33204520, at *3 (B.P.A.I. Mar. 9, 1999) (reversing the examiner's rejection under §§ 102 (a) and (b) because the Board was "constrained" to do so based on the presumption of novelty).
153. Paul R. Michel, The Challenge Ahead: Increasing Predictability in Federal Circuit Jurisprudence for the New Century, 43 AM. U. L. REV. 1231, 1249 (1994) ("If the claimed invention is patentable, the applicant is entitled to a patent (because [§ 102 of] the statute says so)-not eventually, but as soon as patentability can be determined.").
154. Wilder, 429 F.2d at 450; accord In re Sun, 31 U.S.P.Q.2d 1451, 1453 (Fed. Cir. 1993) ("The examiner bears the burden of presenting at least a prima facie case of anticipation."); In re King, 801 F.2d 1324, 1327 (Fed. Cir. 1986) (noting that the Patent Office must establish a prima facie case before any burden shifting occurs); see also In re Rijckaert, 9 F.3d 1531, 1532 (Fed. Cir. 1993) (explaining that an examiner must affirmatively prove unpatentability); In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992) (describing the examiner's initial burden of putting forth a prima facie case of unpatentability).
155. Wilder, 429 F.2d at 451 (noting that a prima facie case is effectively established "whenever a reference is shown to contain a disclosure which is specific as to every critical element of the appealed claims").
156. See In re Samour, 571 F.2d 559, 562-63 (C.C.P.A. 1978) (explaining that although a single prior art reference must disclose each and every element of the claimed compound, the examiner may rely on additional references to show that a PHOSITA had sufficient knowledge to make it).
157. Amgen Inc. v. Hoechst Marion Roussel, Inc., 314 F.3d 1313, 1355 (Fed. Cir. 2003).
158. According to the Federal Circuit, In response to the [Patent Office]'s asserted prima facie case the applicant may argue that the inference of lack of novelty was not properly drawn, for example if the [Patent Office] did not correctly apply or understand the subject matter of the reference, or if the [Patent Office] drew unwarranted conclusions therefrom. However, when the [Patent Office] shows sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not. In re Spada, 911 F.2d 705, 708 (Fed. Cir. 1990).
159. In re Payne, 606 F.2d 303, 315 (C.C.P.A. 1979).
160. Sasse, 629 F.2d at 681.
161. In re Warner, 379 F.2d 1011, 1016 (C.C.P.A. 1967); see also In re Epstein, 32 F.3d 1559, 1570 (Fed. Cir. 1994) (Plager, J., concurring) (articulating the rule that the Patent Office carries the burden of persuasion in showing why an applicant should not receive a patent). Absent any other grounds of unpatentability, the applicant is entitled to the patent. In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992). This raises an interesting question: if the applicant wins on the novelty rejection, can the examiner rely on lack of nonobviousness (§ 103) as an alternative basis for unpatentability? Like novelty, nonobviousness is assessed by comparing the claimed subject matter to the prior art: A patent may not be obtained though the invention is not identically disclosed or described as set forth in § 102... if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a [PHOSITA] to which said subject matter pertains.... 35 U.S.C. § 103(a) (2006). So in contrast to novelty, which asks whether the invention is new, the nonobviousness inquiry seeks to ascertain whether the invention is "new enough" to be patented.
162. The facts in In re Hoeksema, 399 F.2d 269 (C.C.P.A. 1968), illustrate a typical scenario. Upon filing a patent application claiming X, the examiner rejected the claim under § 103 based on a reference that disclosed the structurally similar compound, X′.
163. Under well-settled law, structurally similar compounds are prima facie obvious. In re Hass, 141 F.2d 122, 125-26 (C.C.P.A. 1944) (early recognition); In re Dillon, 919 F.2d 688, 692-93 (Fed. Cir. 1990) (en banc) (collecting cases and reaffirming Hass). In rebuttal, the applicant (1) proved by affidavit that the cited reference did not teach a PHOSITA how to make X and (2) pointed out that the examiner did not cite any secondary references that did so. Hoeksema, 399 F.2d at 271-72. The Board nonetheless affirmed the examiner's rejection, contending that a method of making X was only one factor to be considered in the § 103 analysis. Id. at 273. The C.C.P.A. reversed the Board. In accordance with its post-Von Bramer jurisprudence, the C.C.P.A. held that "if the prior art of record fails to disclose or render obvious a method for making a claimed compound, at the time the invention was made, it may not be legally concluded that the compound itself is in the possession of the public.".
164. But see In re Mahoney, 411 F.2d 1321, 1323-24, 1325 (C.C.P.A. 1969) (affirming a § 103 rejection because, in contrast to Hoeksema, the examiner proved that there were obvious, available processes for making the compound at issue). In sum, an examiner cannot rely on § 103 to circumvent the requirement for enabling prior art. As Judge Rich later explained, [A] reference which merely describes a thing... without telling how to make it... [will] not support a holding of anticipation unless a [PHOSITA] could take its teachings in combination with his own knowledge of the particular art and be in possession of [it], or [will] not support a holding of obviousness unless there is some known or obvious way to make the thing.... In re Collins, 462 F.2d 538, 542-43 (C.C.P.A. 1972) (citation and internal quotation marks omitted); see also Ashland Oil, Inc. v. Delta Resins & Refractories, Inc., 776 F.2d 281, 297 (Fed. Cir. 1985) ("The test of whether a particular compound described in the prior art may have been relied upon to show that the claimed subject matter at issue would have been obvious is whether the prior art provided an enabling disclosure with respect to the disclosed prior art compound."). But the prior art as a whole must be enabling, not just a single reference.
165. (Citing Beckman Instruments, Inc. v. LKB Produkter AB, 892 F.2d 1547, 1551 (Fed. Cir. 1989) ("Even if a reference discloses an inoperative device, it is prior art for all that it teaches.")).
166. In Amgen Inc. v. Hoechst Marion Roussel, Inc., 314 F.3d 1313 (Fed. Cir. 2003), the Federal Circuit held that when an accused infringer asserts a prior art patent against the patentee (as part of an invalidity defense for a lack of novelty), the district court judge may presume that the subject matter in that patent is enabled. Id. at 1355. Simply put, the accused infringer need not prove enablement. But "[l]ike the applicant in ex parte prosecution,... the patentee may argue that the relevant claimed or unclaimed disclosures of a prior art patent are not enabled and therefore are not pertinent prior art." Id. If the district court finds the patentee's evidence of nonenablement persuasive, the court "must then exclude that particular prior art patent in any anticipation inquiry, for then the presumption has been overcome." Id.; see also Impax Labs., Inc. v. Aventis Pharm. Inc., 545 F.3d 1312, 1316 (Fed. Cir. 2008) (affirming a district court's determination that a prior art patent was nonenabling and thus insufficient to anticipate the claims of the patent-in-suit).
167. Amgen Inc. v. Hoechst Marion Roussel, Inc., 314 F.3d 1313 (Fed. Cir. 2003).
168. The court also made clear that the presumption of enablement is rooted in policy and "does not rely on" the statutory presumption of validity afforded to an issued patent under 35 U.S.C. § 282.
169. In re Sasse, 629 F.2d 675 (C.C.P.A. 1980).
170. Contrary to popular belief, one cannot obtain a patent on a compound simply because it is novel. It must also be useful. 35 U.S.C. § 101 (2006) ("Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter... may obtain a patent therefor."), construed in Brenner v. Manson, 383 U.S. 519, 534-35 (1966) (holding that a compound that lacks a known use and thus fails to provide a specific benefit to the public is unpatentable). Utility is determined as of the applicant's filing date. In re Brana, 51 F.3d 1560, 1567 n.19 (Fed. Cir. 1995).
171. See 37 C.F.R. § 1.132 (2009) (stating that when a claim is rejected, any evidence submitted by the applicant to overcome the rejection must be by way of oath or declaration).
172. A catalyst is a substance (often a metal) that speeds up a reaction. Catalysts are not consumed during the reaction and are often recovered upon its completion.
173. ENCYCLOPEDIA OF SCIENCE AND TECHNOLOGY 90 (James Trefil ed., 2001).
174. See 37 C.F.R. § 1.113 (stating that on a second or subsequent examination the rejection may be made final). A rejection is not appealable until it has been made final. 35 U.S.C. § 134(a) (2006).
175. For a discussion of the Board and its procedures, see infra note 142.
176. In re Sasse, 629 F.2d 675, 681-82 (C.C.P.A. 1980).
177. See Bristol-Myers Squibb Co. v. Ben Venue Labs., Inc., 246 F.3d 1368, 1379 (Fed. Cir. 2001) (explaining that the factfinder may look to "any" additional references that establish that the allegedly anticipatory reference was enabling to a PHOSITA during the relevant time period, including references that postdate the primary reference).
178. Though tempting, hindsight reasoning is impermissible in both novelty (35 U.S.C. § 102) and nonobviousness (35 U.S.C. § 103) analyses. See KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 421 (2007) (cautioning factfinders to be aware of hindsight bias and its reliance on ex post reasoning); Graham v. John Deere Co., 383 U.S. 1, 36 (1966) (discussing the need to "guard against slipping into use of hindsight" (quoting Monroe Auto Equip. Co. v. Heckethorn Mfg. & Supply Co., 332 F.2d 406, 412 (1964)); In re Ruschig, 343 F.2d 965, 974 (C.C.P.A. 1965) (warning against "hindsight anticipation[]," in which the applicant's disclosure is used as a guide to dissect and recombine references to describe specific compounds within the meaning of § 102); In re Sporck, 301 F.2d 686, 690-91 (C.C.P.A. 1962) (explaining the court's unwillingness to substitute speculation and hindsight appraisal of the prior art for factual evidence of nonobviousness). It is important to note that Ruschig-type "hindsight anticipation" is inapposite when a compound is specifically recited by name or structure.
179. See Andrew Chin, Artful Prior Art and the Quality of DNA Patents, 57 ALA. L. REV. 975, 1000 (2006) (exploring anticipation issues that can arise when the asserted prior art reference discloses a voluminous list of compounds).
180. Nonetheless, hindsight problems might arise when the examiner is allowed to pick and choose among documents to describe what the PHOSITA knew in the past.
181. Gregory N. Mandel, Patently Non-Obvious: Empirical Demonstration That the Hindsight Bias Renders Patent Decisions Irrational, 67 OHIO ST. L.J. 1391, 1402 (2006).
182. (Citing Baruch Fischhoff, For Those Condemned to Study the Past: Heuristics and Biases in Hindsight, in JUDGMENT UNDER UNCERTAINTY 335, 341 (Daniel Kahneman et al. eds., 1982)).
183. Dan L. Burk & Mark A. Lemley, Is Patent Law Technology-Specific?, 17 BERKELEY TECH. L.J. 1155, 1199 (2002).
184. See also R. Polk Wagner, Reconsidering Estoppel: Patent Administration and the Failure of Festo, 151 U. PA. L. REV. 159, 205 (2002) ("[In considering] enablement, which is measured through the lens of the knowledge of the relevant field as of the filing date of the patent application[, a]s the filing date becomes distant, the potential for cognitive biases, such as a hindsight bias, increases." (footnote omitted)).
185. See Sasse, 629 F.2d at 681-82 ("It was incumbent upon appellants to rebut the presumed operability of the copper catalyst method described in [the organic textbook]. As did the [B]oard, we find the Sasse declaration devoid of any persuasive factual bases for dismissing the proposed catalytic synthesis. Sasse does not employ any copper catalyst in the attempted preparation of the precursors." (emphasis added)).
186. It is well settled in U.S. patent law that conception, and not any physical act, is the key facet of the inventive process. See Pfaff v. Wells Elecs., Inc., 525 U.S. 55, 60-61 (1999) ("[T]he word 'invention' in the Patent Act unquestionably refers to the inventor's conception rather than to a physical embodiment of that idea."); Burroughs Wellcome Co. v. Barr Labs., Inc., 40 F.3d 1223, 1227-28 (Fed. Cir. 1994) (explaining that "[c]onception is the touchstone of inventorship," which only requires "'the formation, in the mind of the inventor, of a definite and permanent idea of the complete and operative invention'" (quoting Hybritech Inc. v. Monoclonal Antibodies, Inc., 802 F.2d 1367, 1376 (Fed. Cir. 1986))). Thus, an applicant who "constructively" reduces an invention to practice by merely filing a patent application presumably has complied with the disclosure requirements of § 112, including the obligation to enable a PHOSITA to make and use the invention without undue experimentation. Hybritech Inc., 802 F.2d at 1376. There may be occasions, however, when an actual reduction to practice is a de facto requirement.
187. For example, several cases suggest that an applicant must supply actual experimental data for inventions in unpredictable technologies in the early stages of development or when an applicant purports to invent something that is contrary to well-settled scientific principles.
188. A document that specifically names thousands or millions of chemical compounds is referred to as a "shotgun" reference. In re Schoenewaldt, 343 F.2d 1000, 1002 (C.C.P.A. 1965). Yet a shotgun reference can potentially anticipate each recited compound if the disclosure is sufficiently enabling. See infra note 192. There are at least five reasons why a patentee would disclose subject matter but not claim it. First, a third party may intentionally disclose unclaimed material to create novelty problems for subsequent inventors. Second, it could be an unintentional error.
189. See Michael J. Meuer & Craig Allen Nard, Invention, Refinement and Patent Claim Scope: A New Perspective on the Doctrine of Equivalents, 93 GEO. L.J. 1947, 1951-52 (2005) (explaining that an applicant's ability to claim everything the applicant has enabled depends on the talent and effort of the inventor and patent prosecutor in identifying what has been enabled).
190. Third, because the written description places an outer limit on claim scope, Nat'l Recovery Techs., Inc. v. Magnetic Separation Sys., Inc., 166 F.3d 1190, 1196 (Fed. Cir. 1999), one way to avoid § 112, ¶ 1, issues is to draft a disclosure that is broader than the claims. Fourth, the applicant could strategically craft narrow claims to avoid scrutiny by the Patent Office during prosecution and then, after issuance, rely on the broad disclosure to enlarge the scope of the claims in litigation. See Genentech, Inc. v. Wellcome Found. Ltd., 29 F.3d 1555, 1564 (Fed. Cir. 1994) (discussing this strategy). This tactic has been severely limited by the disclosure-dedication rule. See PSC Computer Prods., Inc. v. Foxconn Int'l, Inc., 355 F.3d 1353, 1361 (Fed. Cir. 2004) (explaining that the disclosure-dedication rule should "motivate patentees to draw the broadest claims that they consider to be patentable, and to submit the broad claims to the [Patent Office] for examination"); Johnson & Johnston Assocs. Inc. v. R.E. Serv. Co., 285 F.3d 1046, 1054 (Fed. Cir. 2002) (en banc) (per curiam) (holding that disclosed but unclaimed subject matter is dedicated to the public). Fifth, an applicant may want to use continuation practice to gain advantages over competitors. See infra note 232.
191. See U.S. PATENT & TRADEMARK OFFICE, U.S. DEP'T OF COMMERCE, MANUAL OF PATENT EXAMINING PROCEDURE § 2164.08 (8th ed., rev. 8, 2010) [hereinafter MPEP] ("All questions of enablement are evaluated against the claimed subject matter."); see also Engel Indus., Inc. v. Lockformer Co., 946 F.2d 1528, 1531 (Fed. Cir. 1991) ("Unclaimed subject matter is not subject to the disclosure requirements of § 112; the reasons are pragmatic: the disclosure would be boundless, and the pitfalls endless.").
192. Miller v. Bridgeport Brass Co., 104 U.S. 350, 352 (1881) ("[T]he claim of a specific device or combination, and an omission to claim other devices or combinations apparent on the face of the patent, are, in law, a dedication to the public of that which is not claimed."); Johnson & Johnston, 285 F.3d at 1054 ("[W]hen a patent drafter discloses but declines to claim subject matter... this action dedicates that unclaimed subject matter to the public."). This practice may trigger the disclosure-dedication rule, which bars a finding of patent infringement when an accused infringer practices disclosed but unclaimed subject matter.
193. STEPHEN A. HANSEN & JUSTIN W. VANFLEET, TRADITIONAL KNOWLEDGE AND INTELLECTUAL PROPERTY: A HANDBOOK ON ISSUES AND OPTIONS FOR TRADITIONAL KNOWLEDGE HOLDERS IN PROTECTING THEIR INTELLECTUAL PROPERTY AND MAINTAINING BIOLOGICAL DIVERSITY 24 (2003), available at http://shr.aaas.org/tek/handbook/handbook.pdf.
194. Defensive disclosure is "information or documentation intentionally made available to the public as prior art in order to render any subsequent claims of invention or discovery ineligible for a patent.".
195. Several commentators have explored the strategy of defensive publication.
196. See, e.g., Douglas Lichtman, Scott Baker & Kate Kraus, Strategic Disclosure in the Patent System, 53 VAND. L. REV. 2175, 2175-76 (2000) (discussing a competitor's strategic incentive to create prior art).
197. Gideon Parchomovsky, Publish or Perish, 98 MICH. L. REV. 926, 927 (2000) (same).
198. Sources cited infra notes 128-29.
199. CHRIS P. MILLER & MARK J. EVANS, THE CHEMIST'S COMPANION GUIDE TO PATENT LAW 170 n.4 (2010).
200. See also Scott Baker & Claudio Mezzetti, Disclosure as a Strategy in the Patent Race, 48 J.L. & ECON. 173, 175 (2005) ("[These] disclosures are designed to preempt patents in instances where the disclosing firm does not itself plan to pursue patent protection but fears that its rivals might.").
201. Bill Barrett, Defensive Use of Publications in an Intellectual Property Strategy, 20 NATURE BIOTECH. 191, 191-93 (2002) (providing strategies for drafting patent disclosures in unpredictable fields).
202. Infra note 161.
203. Anthony Murphy, Intellectual Property, in INNOVATION: HARNESSING CREATIVITY FOR BUSINESS GROWTH 92 (Adam Jolly ed., 2003).
204. See John Hoxie, A Patent Attorney's View, 47 J. PAT. & TRADEMARK OFF. SOC'Y 630, 636 (1965) (exploring the evolution of inventions from being mostly electrical-mechanical to chemical in nature).
205. William D. Noonan, Patenting Medical Technology, 11 J. LEGAL MED. 263, 263-64 (1990) (same).
206. Quite curiously, the first patent granted in the United States was for an improved method for making potash (potassium carbonate), America's first industrial chemical. See U.S. Patent No. X1 (issued July 31, 1790).
207. NAT'L ACAD. OF ENG'G, THE COMPETITIVE STATUS OF THE U.S. PHARMACEUTICAL INDUSTRY 7-11 (1983).
208. Mary T. Griffin, AIDS Drugs & the Pharmaceutical Industry: A Need for Reform, 17 AM. J.L. & MED. 363, 365-66 (1991) (describing the pharmaceutical industrial revolution).
209. 2; assigned to Merck); Process of Treating Pregnene Compounds, U.S. Patent No. 2,462,133 (issued Feb. 22, 1949) (synthesis of cortisone; assigned to Merck). Interestingly, the familiar wonder drugs sulfanilamide (the first sulfa drug) and penicillin were unpatentable (for a lack of novelty) by the time their therapeutic properties came to light because the substances were already in the public domain.
210. See Ronald Bentley, Different Roads to Discovery; Prontosil (Hence Sulfa Drugs) and Penicillin (Hence β-Lactams), 36 J. INDUS. MICROBIOLOGY & BIOTECH. 775, 775-86 (2009).
211. Peter Drahos & John Braithwaite, Intellectual Property, Corporate Strategy, Globalization: TRIPS in Context, 20 WIS. INT'L L.J. 451, 463-64 (2002) (explaining that during this era drug companies found patent protection vital because they knew that "[p]enicillin, which had not been patented, had gone from costing $3,955 per pound in 1945 to $282 per pound in 1950").
212. Peter Temin, Technology, Regulation, and Market Structure in the Modern Pharmaceutical Industry, 10 BELL J. ECON. 429, 436 (1979) (describing the transformation of the pharmaceutical industry from a production to a research model).
213. The "antibiotic revolution" presents an interesting story. Given penicillin's success and the potential for antibiotics to generate unprecedented profits, pharmaceutical companies sought other antibiotics by screening potential antibiotic-producing microorganisms from nature.
214. GRAHAM DUTFIELD, INTELLECTUAL PROPERTY RIGHTS AND THE LIFE SCIENCE INDUSTRIES: PAST, PRESENT AND FUTURE 141-42 (2d ed. 2009).
215. But "it was uncertain if the patent system and the courts could deliver [the blanket patent protection] they wanted" because the compounds were essentially "gifts of nature" and thus evinced very little inventive creativity. Id. at 142. Professor William Kingston describes how the pharmaceutical industry took quick action: The previous [Patent Act] dated from 1870, and did not suit the new methods of research needed for antibiotics.... On behalf of their pharmaceutical industry clients, New York Patent Bar Association members drafted a Bill and were able to get it introduced in Congress, and this, supplemented by other Bills and pressures, brought about the changes they wanted.
216. William Kingston, Removing Some Harm from the World Trade Organization, 32 OXFORD DEV. STUD. 309, 310 (2004).
217. The basic change was the incorporation of language in the nonobviousness provision of the 1952 Patent Act, see Act of July 19, 1952, Pub. L. No. 82-593, § 1, 66 Stat. 792, 792, 798 (codified as amended at 35 U.S.C.) ("Patentability shall not be negatived by the manner in which the invention was made."), tailored to keep the innovation threshold rather low.
218. The courts quickly developed a bias against patent applications involving biological systems and pharmaceutical compounds.
219. As an example, consider streptomycin, another first-generation wonder drug that is (like penicillin) a mold- produced antibiotic. Historically, purified natural products were not always patentable. See Am. Wood-Paper Co. v. Fiber Disintegrating Co., 90 U.S. (23 Wall.) 566, 593-94 (1874) (holding that purified cellulose was unpatentable although the process for obtaining it might be). Yet, in 1948, the Patent Office granted Merck a patent for streptomycin because the chemical modifications allowing it to be purified created a new composition of matter. See Complex Salts of Streptomycin and Process for Preparing Same, U.S. Patent No. 2,446,102 cols. 2.4-.8 (issued July 27, 1948) ("[F]or the first time streptomycin is available in a form which not only has valuable therapeutic properties but also can be produced, distributed, and administered in a practicable way."); cf. Parke-Davis & Co. v. H.K. Mulford Co., 189 F. 95, 103 (C.C.S.D.N.Y. 1911) (upholding a patent for a purified adrenaline salt because removing it from gland tissue produced a new composition of matter), aff'd in part and rev'd in part on other grounds, 196 F. 496 (2d Cir. 1912). The streptomycin patent was an important legal development because "it clarified to the industry that the new antibiotics were patentable despite being 'products of nature.'".
220. GRAHAM DUTFIELD & UMA SUTHERSANEN, GLOBAL INTELLECTUAL PROPERTY LAW 300 (2008).
221. The law of patents as applied to the experimental sciences has been described as "a child (or orphan) of mechanical patent law.".
222. Paul H. Eggert, Uses, New Uses and Chemical Patents-A Proposal, 51 J. PAT. & TRADEMARK OFF. SOC'Y 768, 783 (1969).
223. See, e.g., Jackie Hutter, Note, A Definite and Permanent Idea? Invention in the Pharmaceutical and Chemical Sciences and the Determination of Conception in Patent Law, 28 J. MARSHALL L. REV. 687, 719-21 (1995) (arguing that the Federal Circuit should adopt a standard of invention tailored to meet the needs of unpredictable activities like drug discovery).
224. 5(halide)." Given that a PHOSITA (or anyone who has taken a general chemistry course) knows that there are only five halides (F, Cl, Br, I, At), the disclosure almost certainly meets the Petering test. In other words, the third-party patent "has described to [the PHOSITA] each of the various premutations [sic]... involved as fully as if [the patentee] had drawn each structural formula or had written each [by] name." Id. at 682. Thus, if the disclosure is enabling, the third-party patent might be sufficient to anticipate a subsequent claim to X, even though X is not specifically recited. But just because the genus is small (as in the case of the halides) does not mean that enablement of one member of the group is always sufficient to enable the others.
225. For an example explaining that, because the other halides require different reaction protocols, the general method used to prepare aryl chlorides and aryl bromides from diazonium salts and copper does not work for them, see MICHAEL B. SMITH & JERRY MARCH, MARCH'S ADVANCED ORGANIC CHEMISTRY 984 (6th ed. 2007).
226. 5F.
227. See infra Part II.B.2.
228. See, e.g., In re '639 Patent Litig., 154 F. Supp. 2d 157, 172-87 (D. Mass. 2001) (determining that the claims of a patent that recited a compound were invalid due to anticipation by a prior art reference), aff'd, SmithKline Beecham Corp. v. Copley Pharm., Inc., 45 F. App'x 915 (Fed. Cir. 2002); Ex parte Nicolaou, No. 2007-1076, 2007 WL 3408644, at *4 (B.P.A.I. Nov. 13, 2007) (reversing an examiner's rejection of claims to compounds because the prior art's disclosure was nonenabling). In its appellate role, the Board of Patent Appeals and Interferences reviews adverse decisions of examiners. 35 U.S.C. § 6(b) (2006). An applicant whose claims have been twice rejected by the examiner may appeal to the Board. Id. § 134(a). The Board can affirm a rejection or reverse and remand to the examining corps. 37 C.F.R. § 1.197 (2009) (promulgating Patent Office regulations pertaining to the Board). An applicant dissatisfied with a Board decision can appeal to the Federal Circuit. 35 U.S.C. § 141 (2006).
229. In re Von Bramer, 127 F.2d 149 (C.C.P.A. 1942).
230. Thirty-six years later, Judge Baldwin made a similar argument: "A compound is described by a reference, in my view, if the reference recites the structure and recites or reliably and accurately predicts at least one significant property of the compound.... I would treat the actual existence of the compound as legally equivalent to such a significant property." In re Samour, 571 F.2d 559, 564 (C.C.P.A. 1978) (Baldwin, J., concurring).
231. Von Bramer, 127 F.2d at 151.
232. See Cohn v. U.S. Corset Co., 93 U.S. 366, 377 (1876) ("It is quite immaterial, even if it be a fact, that the [third-party patent's disclosure] is insufficient to teach a manufacturer how to make the patented corset. It is enough if it sufficiently describes the corset itself.").
233. In contrast to corset making, organic chemistry is an unpredictable art.
234. Nonetheless, it appears that the Von Bramer court may have taken dictum in Cohn out of context. See Von Bramer, 127 F.2d at 152 (citing Cohn for the proposition that "[i]t is not necessary that a reference patent for a device or chemical compound disclose an operative process for producing the article or product").
235. Twenty years later, the C.C.P.A. explained that a consideration of knowledge in the art was "implicit" in the Von Bramer opinion. See In re LeGrice, 301 F.2d 929, 942 (C.C.P.A. 1962) (stating that there is an assumption that a PHOSITA will use his knowledge in combination with the printed materials).
236. The opinion included an excerpt from the examiner's correspondence, which stated that the compound-at-issue "ha[s] generally predictable properties such as found for any similar N-alkyl amino phenol, and is generally capable of synthesis by the recognized classical organic reactions." Von Bramer, 127 F.2d at 152. Two decades later, Judge Jackson (the author of the Von Bramer opinion) stated that this so-called predictability was a relevant consideration. Phillips Petrol. Co. v. Ladd, 219 F. Supp. 366, 369 (D.D.C. 1963); accord In re Brown, 329 F.2d 1006, 1010 (C.C.P.A. 1964) (suggesting that predictability should be considered in evaluation of claims). But trying to classify organic synthesis as predictable, even for compounds within the same class, can be problematic.
237. Donald G. Daus, Chemical Names as Anticipation and Support, 70 J. PAT. & TRADEMARK OFF. SOC'Y 377, 381 (1988).
238. See In re Stoll, 161 F.2d 241, 243 (C.C.P.A. 1947) ("A compound previously described by name in a printed publication such as an issued patent is a disclosure which is sufficient to support the rejection of a claim for that compound."); In re Crosley, 159 F.2d 735, 736 (C.C.P.A. 1947) ("Furthermore, this court is committed to the doctrine that where a product is clearly disclosed in a publication, the operativeness of any of the processes by which it is claimed the product could be produced is immaterial, and that the disclosure of the composition is sufficient to anticipate a claim therefor.").
239. Maurice W. Levy, Von Bramer: A Plea for Reorientation, 33 J. PAT. OFF. SOC'Y 401, 401-27 (1951) (same).
240. In re Baranauckas, 228 F.2d 413, 415 (C.C.P.A. 1956).
241. For example, see Ex Parte Nagy, 106 U.S.P.Q. 424, 425 (P.T.O. Bd. App. 1955) (holding that a compound recited in the prior art was sufficient to anticipate even though the prior art method of preparation failed).
242. In re Brown, 329 F.2d 1006, 1010 (C.C.P.A. 1964) ("To the extent that anyone may draw an inference from the Von Bramer case that the mere printed conception... of a 'compound' is sufficient to show that [it] is old [for § 102 or § 103 purposes], we totally disagree."); In re LeGrice, 301 F.2d 929, 942 (C.C.P.A. 1962) (stating that the court disagrees with any case, including Von Bramer, that conflicts with Cohn). Why did the C.C.P.A. change its mind? It may have done so due to several substantial enhancements to the court's technical competence. First, the addition of Judges Giles Rich and Arthur Smith (author of LeGrice) in the 1950s brought technical astuteness and patent expertise to the court.
243. See GILES S. RICH, A BRIEF HISTORY OF THE UNITED STATES COURT OF CUSTOMS AND PATENT APPEALS 131-33, 143-44 (1980) (discussing the appointments of Judges Rich and Smith to the C.C.P.A. and describing each of these judges' professional backgrounds).
244. Second, in 1955, Judge Eugene Worley (later Chief Judge) argued that each judge on the C.C.P.A. should have a technical advisor to assist in patent cases. Id. at 118-19. He envisioned a group of advisors "thoroughly skilled in the advanced fields of electronics, chemistry, and related sciences" to assist with the "increasing volume and technicalities" of the court's patent docket. Id. at 119. Although Judge Worley initially faced resistance from his colleagues, the court hired its first technical advisor, the (former) Solicitor of the Patent Office, that same year. Id. at 118-19. Eventually the C.C.P.A. judges began a tradition of hiring technically trained law clerks, giving the court "a considerable pool of technological assistance" that was kept fresh because newer clerks had "the latest training in their respective fields.".
245. In re Papesch, 315 F.2d 381 (C.C.P.A. 1963).
246. Cf. Regents of the Univ. of N.M. v. Knight, 321 F.3d 1111, 1122 (Fed. Cir. 2003) ("Indeed, a chemical structure is simply a means of describing a compound; it is not the invention itself.").
247. In re Wiggins, 488 F.2d 538 (C.C.P.A. 1973).
248. Cf. Picard v. United Aircraft Corp., 128 F.2d 632, 635 (2d Cir. 1942) ("[A]nother's experiment, imperfect and never perfected, will not serve either as an anticipation or as part of the prior art, for it has not served to enrich it.").
249. Wiggins, 488 F.2d at 543.
250. Interestingly, the court hinted at this problem during the Von Bramer era: At the same time, however, though our decision is compelled by the existing law, we feel constrained to point out that there are limits to the [Von Bramer] doctrine.... What the precise boundary lines are, we are unable now to discern. Certainly they do not extend so far as to permit publication of theoretical lists of hundreds or thousands of possible compounds to deny patent protection on such compounds to those who actually discovered them later. The exact boundaries will have to be delineated on a case by case basis. In re Baranauckas, 228 F.2d 413, 416 (C.C.P.A. 1956).
251. In re Sheppard, 339 F.2d 238 (C.C.P.A. 1964).
252. Wiggins, 488 F.2d at 542-44 (explaining that although the reference described X by name, its failed synthesis, plus the lack of evidence that a PHOSITA could make it at that time, made the reference nonenabling); Sheppard, 339 F.2d at 241 (explaining that X's decomposition during synthesis created uncertainty about the reference's teaching and thus made the disclosure nonenabling). Neither opinion cites United States v. Adams, 383 U.S. 39 (1996), in which the U.S. Supreme Court stated that "[a]n inoperable invention or one which fails to achieve its intended result does not negative novelty.".
253. See infra note 177.
254. In re Samour, 571 F.2d 559 (C.C.P.A. 1978).
255. See Cont'l Can Co. v. Monsanto Co., 948 F.2d 1264, 1269 (Fed. Cir. 1991) (discussing the "modest flexibility" in the single-reference rule that allows a secondary reference to accommodate situations in which the PHOSITA's knowledge cannot be gleaned from the primary reference); In re Donahue, 766 F.2d 531, 534 (Fed. Cir. 1985) (applying Samour to affirm a Patent Office multiple-reference rejection for a lack of novelty); Studiengesellschaft Kohle, M.B.H. v. Dart Indus., Inc., 726 F.2d 724, 726-27 (Fed. Cir. 1984) (recognizing the "caveat" to the single-reference rule); Samour, 571 F.2d at 562-63 (explaining that while a single prior art reference must disclose each and every element of the claimed compound, the examiner may rely on additional references to show that a PHOSITA had sufficient knowledge to make it). The secondary reference can even postdate the primary reference. See Samour, 571 F.2d at 563 (explaining that the relevant inquiry is whether the compound was already in possession of the public more than one year prior to the applicant's filing date under § 102(b) and not whether evidence showing such possession came before or after the date of the primary reference).
256. Lack of novelty (35 U.S.C. § 102) and lack of nonobviousness (35 U.S.C. § 103) are substantively distinct grounds for denying patentability. Most would agree that nonobviousness only comes into play after the novelty inquiry is complete. See In re Bergy, 596 F.2d 952, 960 (C.C.P.A. 1979) (explaining that an applicant must "hav[e] separate keys to open in succession the three doors of sections 101, 102, and 103") (emphasis added)), aff'd in relevant part sub nom. Diamond v. Chakrabarty, 447 U.S. 303 (1980).
257. For novelty, all of the claim elements are found within the primary reference. Samour, 571 F.2d at 563. By contrast, obviousness is often shown when the claim elements are found across multiple references. See Cohesive Techs., Inc. v. Waters Corp., 543 F.3d 1351, 1363-64 (Fed. Cir. 2008) (explaining the distinction). Nonetheless, the prior art used for a nonobviousness rejection must also be enabling.
258. In re Marshall, 578 F.2d 301, 304 (C.C.P.A. 1978) (discussing Samour and how its holding still comports with the single-reference rule).
259. In re Donahue, 766 F.2d 531 (Fed. Cir. 1985).
260. In attempting to distinguish Donahue from the Sheppard-Wiggins scenario, the Federal Circuit stated, In those cases, the references were deemed insufficient, because they stated that attempts to prepare the claimed compounds were unsuccessful. Such failures by those skilled in the art (having possession of the information disclosed by the publication) are strong evidence that the disclosure of the publication was nonenabling.
261. See also Fromson v. Advance Offset Plate, Inc., 755 F.2d 1549, 1558 (Fed. Cir. 1985) (noting that a failed experiment reported in a third-party patent makes it irrelevant as a prior art reference).
262. See Donahue, 766 F.2d at 533 ("By contrast, the fact that the author of a publication did not attempt to make his disclosed invention does not indicate one way or the other whether the publication would have been enabling.").
263. See, e.g., GERARD H. GAYNOR, INNOVATION BY DESIGN 140 (2002) (observing that experimental failure is part of the innovative process and that lessons can be learned from it).
264. ALVIN TOFFLER, POWERSHIFT 213 (1990) ("Innovation... requires experimental failure to achieve success.").
265. FREDERICK GRINNELL, EVERYDAY PRACTICE OF SCIENCE 9 (2009).
266. As one commentator notes, Physical scientists often publish their failed experiments. Though not as satisfying as successful ones, certain failures give information that is truly useful. If nothing else, a well-documented failure says, "You don't have to bother with this technique. It doesn't work, at least not... the way I tried it."... [Thus p]hysical scientists, in publishing their failures, help their brethren.
267. BRUCE JACKSON, FIELDWORK 14 (1987).
268. See ALAN AXELROD, EDISON ON INNOVATION 40-42 (2008) (describing Thomas Edison's view that failed experiments always provide useful information and thus are not really failures at all).
269. DOROTHY LEONARD-BARTON, WELLSPRINGS OF KNOWLEDGE 119-20 (1998) (exploring the role of failed experiments in knowledge building).
270. STEFAN H. THOMKE, EXPERIMENTATION MATTERS: UNLOCKING THE POTENTIAL OF NEW TECHNOLOGIES FOR INNOVATION 23 (2003) ("Innovators learn from failure.... [K]nowledge of either failure or success itself can be stockpiled, providing a resource that, if not applicable to one set of experiments, can be used for subsequent inquiries.").
271. Failed experiments can lead to accidental discoveries, thereby converting failure into success.
272. In re Jacobs, 318 F.2d 743 (C.C.P.A. 1963).
273. The applicant's argument that the disclosed method did not work raises an interesting technical question. As one commentator explains, "It is all too easy for a skilled person to say that he tried, but failed, to prepare a prior art compound, but is that because his task was impossible or because he performed the task incompetently, or at least not so competently as other skilled workers might do?".
274. Jacobs, 318 F.2d at 745 (emphasis added).
275. The Patent Office has tried, albeit unsuccessfully, to make this argument. See In re Coker, 463 F.2d 1344, 1346-48 (C.C.P.A. 1972) (rejecting the Board's argument that a PHOSITA in the field of organic chemistry is well aware of numerous methods for making compounds like X even though the third-party patentee was unsuccessful in doing so).
276. The subsequent inventor can possibly obtain a "new use" patent for X even if it is known in the prior art. See 35 U.S.C. § 100(b) (2006) (defining a patentable "process" to "include[] a new use of a known... composition of matter, or material"); Merck & Co., Inc. v. Teva Pharm. USA, Inc., 347 F.3d 1367, 1372 (Fed. Cir. 2003) (explaining that a new use for a known compound can be patented with a "method" claim). There are, however, two principal reasons why a "compound" or "composition of matter claim" covering X itself tends to be more valuable than those directed to a specific "method of making" or "method of using" X. First, compound claims afford the broadest protection. As Professor Harold Wegner explains, Compound claims have always been the premium form of patent protection in the chemical industry.... A claim to the compound, per se, dominates every method of making that compound and every single use of that compound, every single mixture of different components that includes that compound, and every end use composition inclusive of the compound.
277. See also In re Papesch, 315 F.2d 381, 391 (C.C.P.A. 1963) (discussing the "well-recognized advantages" of composition-of-matter claims).
278. MARTIN A. VOET, THE GENERIC CHALLENGE: UNDERSTANDING PATENTS, FDA & PHARMACEUTICAL LIFE-CYCLE MANAGEMENT 82-85 (2d ed. 2008) (describing the "hierarchy" of patent claims and noting that composition patents are the best for pharmaceuticals).
279. Second and relatedly, method patents are difficult to enforce because the patentee "acquires only the right to preclude others from using the chemical in the exact manner he has disclosed.".
280. Thus, the new-use patent might be too narrow to cover other uses for X that come to the fore during its lifespan.
281. See Rebecca S. Eisenberg, The Problem of New Uses, 5 YALE J. HEALTH POL'Y L. & ETHICS 717, 720 (2005) ("The discovery of a new use for an old drug might support a patent on a method of treatment, but such a patent offers little effective protection against generic competition once the drug itself is off-patent and may lawfully be sold for an older, unpatented use.").
282. Rebecca S. Eisenberg, The Role of the FDA in Innovation Policy, 13 MICH. TELECOMM. & TECH. L. REV. 345, 351 (2007) [hereinafter Eisenberg, The Role of the FDA] ("Patents on particular methods of treatment involving the use of a drug are generally considered less valuable[] because they cannot be used to stop competitors from selling the same product for other uses.").
283. Third, a patentee seeking a new-use claim may face a formidable nonobviousness hurdle. See Allegheny Drop Forge Co. v. Portec, Inc., 541 F.2d 383, 386 (3d Cir. 1976) ("A new use for an old process or product is patentable if the new use or application is itself not 'obvious' to [a PHOSITA].").
284. Michael Abramowicz, The Danger of Underdeveloped Patent Prospects, 92 CORNELL L. REV. 1065, 1100 (2007) (explaining that in the drug context, a new-use patent "may be difficult to obtain because the 'new' use may have been obvious, even if it was not obvious that the new use would be effective").
285. But despite these drawbacks, a method patent can provide fairly strong protection in certain situations.
286. See, e.g., Lorie Ann Morgan & Jeffrey Tidwell, Patents: United States Perspective, in 4 ENCYCLOPEDIA OF PHARMACEUTICAL TECHNOLOGY 2616, 2617 (James Swarbick ed., 3d ed. 2007) (arguing that method-of-use claims can afford important protection for pharmaceuticals because FDA approval is linked to specific therapeutic uses).
287. Kevin Outterson, Death from the Public Domain?, 87 TEX. L. REV. SEE ALSO 45, 50 (2009), http://www.texaslrev.com/sites/default/files/seealso/vol87/pdf/87TexasLRevSeeAlso45.pdf (observing that if X is already patented or in the public domain, pharmaceutical companies will seek claims for new uses or formulations).
288. Perhaps not surprisingly, savvy patentees who pursue composition-of-matter claims to X often also include at least one method-of-use claim so that if an opponent (in litigation) uncovers prior art sufficient to invalidate the former, the patentee will retain a strong patent position.
289. Yet regardless of the potential availability of a method-of-use patent, a subsequent inventor should not have to settle for one if the asserted prior art has not truly enabled X; the subsequent inventor should still be able to claim the compound itself.
290. Technically speaking, it is possible for a shotgun reference (one reciting a voluminous list of compounds) to sufficiently enable each recited compound. See In re Sivaramakrishnan, 673 F.2d 1383, 1384-85 (C.C.P.A. 1982) (holding that in contrast to Wiggins and the applicant's contention that the disclosure was speculative, a PHOSITA could follow the reference's teachings and rely on knowledge in the art to make the specific compound at issue, even though the teaching was generic); Ex Parte A, 17 U.S.P.Q.2d 1716, 1718-19 (B.P.A.I. 1990) (explaining that if a reference specifically teaches a listed compound, the reference anticipates regardless of the size of the list).
291. The principle that anticipatory prior art must provide specific details finds its roots in English patent cases: Whatever, therefore, is essential to the invention must [appear in] the prior publication. If specific details are necessary for the practical working... of the alleged invention, they must be found substantially in the prior publication. Apparent generality, or a proposition not true to its full extent, will not prejudice a subsequent statement which is limited and accurate.... Seymour v. Osborne, 78 U.S. (11 Wall.) 516, 555 n.24 (1870) (citing Hill v. Evans, (1862) 45 Eng. Rep. 1195, 1200 (Q.B.)). In a leading British case addressing anticipatory enablement, Lord Hoffmann described the requisite level of disclosure for a third-party patent: To anticipate the [subsequent inventor's] claim the prior publication must contain clear and unmistakable directions to do what the [subsequent inventor] claims to have invented. A signpost, however clear, upon the road to the... invention will not suffice. The prior inventor must be clearly shown to have planted his flag at the precise destination before the [subsequent inventor]. Gen. Tire & Rubber Co. v. Firestone Tyre & Rubber Co., [1972] R.P.C. 457, 486 (U.K.) (citations omitted).
292. And if there are no additional grounds for unpatentability, the Patent Office must grant the patent. In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992).
293. See Constant v. Advanced Micro-Devices, Inc., 848 F.2d 1560, 1568 (Fed. Cir. 1988) ("The statutory phrase 'printed publication' has been interpreted to mean that [during the relevant time period] the reference must have been sufficiently accessible to the public interested in the art; dissemination and public accessibility are the keys to the legal determination whether a prior art reference was 'published.'"); cf. In re Wyer, 655 F.2d 221, 226 (C.C.P.A. 1981) (explaining that a document is publicly accessible if it "has been disseminated or otherwise made available to the extent that persons interested and ordinarily skilled in the subject matter or art, exercising reasonable diligence, can locate it and recognize and comprehend therefrom the essentials of the claimed invention without need of further research or experimentation").
294. This type of broad disclosure is ubiquitous in patent documents.
295. In this hypothetical, some language is excerpted from Certain Halogenated 2-(2- Thiazolyl)aminofuran-5-ones, U.S. Patent No. 3,444,178 (filed June 16, 1967).
296. One way to test enablement is to determine if a skilled scientist would have believed that the inventor's success with the described embodiment(s) "could be extrapolated with a reasonable expectation of success" to other embodiments encompassed by the broad claims. In re Wright, 999 F.2d 1557, 1564 (Fed. Cir. 1993). Another jurist framed the analysis in similar terms: [W]ith respect to generic claims to chemical and biological inventions, the scope of the claims is limited to what [the PHOSITA] could reasonably predict from the inventor's disclosure. This precept recognizes that one skilled in these chemical and biological arts cannot always reasonably predict how different chemical compounds and elements might behave under varying circumstances. Thus, in so-called "chemical" patent law practice, the claims of a patent are limited by the scope of what the disclosure reasonably teaches to [the PHOSITA]. Nationwide Chem. Corp. v. Wright, 458 F. Supp. 828, 839 (M.D. Fla. 1976), aff'd, 584 F.2d 714 (5th Cir. 1978). Important considerations include "the type[s] of reactions, the state of the art, the representative nature of the examples, and the breadth of the claims." In re Rainer, 377 F.2d 1006, 1012 (C.C.P.A. 1967).
297. See AstraZeneca Pharm. LP v. Teva Pharm. USA, Inc., 583 F.3d 766, 775 (Fed. Cir. 2009) (recognizing that "the properties of these structurally similar compounds [can] vary significantly with minor structural changes"); In re Soll, 97 F.2d 623, 625 (C.C.P.A. 1938) (explaining that a patentee that discloses one member of a class of compounds may not be entitled to claim the entire class because certain members may react differently).
298. For additional commentary on the PHOSITA's identity, see generally John O. Tresansky, PHOSITA-The Ubiquitous and Enigmatic Person in Patent Law, 73 J. PAT. & TRADEMARK OFF. SOC'Y 37 (1991).
299. Joseph P. Meara, Note, Just Who Is the Person Having Ordinary Skill in the Art? Patent Law's Mysterious Personage, 77 WASH. L. REV. 267 (2002).
300. Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001).
301. The confusion arises for several reasons. First, several commentators argue that the PHOSITA does not remain constant from section to section of the patent statute but rather changes based on the purpose being served at that time.
302. Thus, "[t]he PHOSITA for purposes of obviousness may not necessarily be the PHOSITA for purposes of enablement, written description, definiteness, or equivalence." Id. at 1189. This means, of course, that the different PHOSITAs can exhibit different characteristics between sections. Id. at 1190 (explaining that while the authorities view the PHOSITA in the nonobviousness context as a problem solver, they historically viewed the PHOSITA for enablement purposes as one who "show[ed] no such innovative tendency, but [was] simply a user of the technology"). Second, "the knowledge of the PHOSITA in a particular field... frequently change[s] over time.".
303. Mark A. Lemley, The Changing Meaning of Patent Claim Terms, 104 MICH. L. REV. 101, 102 (2005).
304. See also infra note 212. Third and relatedly, evidence shows that the PHOSITA varies by industry.
305. Fourth, unlike the PHOSITA who has a common or ordinary level of skill, patent law presumes that inventors and patentees have extraordinary skill.
306. See also N. Am. Vaccine, Inc. v. Am. Cyanamid Co., 7 F.3d 1571, 1580 (Fed. Cir. 1993) (Rader, J., dissenting) ("Because inventors generally have extraordinary skill, their scientific writings outside the patent are rarely even a source of knowledge about ordinary skill in the art.").
307. Dan L. Burk, Feminism and Dualism in Intellectual Property, 15 AM. U. J. GENDER SOC. POL'Y & L. 183, 189-90 (2007) ("Far from being one of ordinary skill, the inventor is by definition one of extraordinary skill, so that once the mental work has been completed, all that remains to be done has been characterized as the 'work of the mere artisan'-not the work of an inventor.").
308. For instance, Judge Rich described the PHOSITA as a "plodder" who "thinks along the line of conventional wisdom in the art" and does not "undertake[] to innovate, whether by patient, and often expensive, systematic research[,] or by extraordinary insights." Standard Oil Co. v. Am. Cyanamid Co., 774 F.2d 448, 454 (Fed. Cir. 1985). Until quite recently, Judge Rich's view of the PHOSITA as an unimaginative and uncreative person persisted in patent law even as inventions have become more technologically complex.
309. See Rebecca S. Eisenberg, Obvious to Whom? Evaluating Inventions from the Perspective of PHOSITA, 19 BERKELEY TECH. L.J. 885, 888, 891 (2004) (explaining how the Federal Circuit "all but ignored" the PHOSITA because the court presumed "that PHOSITA [was] an uncreative plodder, incapable of making inventions of his own").
310. The Federal Circuit recently abandoned the plodder presumption, however, and now strives to accurately elucidate the PHOSITA's identity. See infra notes 215-19 and accompanying text.
311. Enzo Biochem, Inc. v. Calgene, Inc., 188 F.3d 1362, 1371-72 (Fed. Cir. 1999).
312. Timothy R. Holbrook, Equivalency and Patent Law's Possession Paradox, 23 HARV. J.L. & TECH. 1, 41-43 (2009) (explaining that the level of skill in the art may have evolved since the filing date, which is important because enablement is assessed at the time of application).
313. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007).
314. See also Daralyn J. Durie & Mark A. Lemley, A Realistic Approach to the Obviousness of Inventions, 50 WM. & MARY L. REV. 989, 1000 (2008) ("[After KSR,] courts will have to pay more attention than they have in the last quarter-century to who the PHOSITA is and what he or she thinks.").
315. Joseph Scott Miller, Remixing Obviousness, 16 TEX. INTELL. PROP. L.J. 237, 250 (2008) (recognizing that KSR banished the Federal Circuit's "dullard" PHOSITA).
316. Before KSR, the Federal Circuit and the C.C.P.A. resolved the question with the "teaching, suggestion, or motivation" (TSM) test, which deemed a patent claim obvious if some motivation or suggestion to combine the prior art teachings could be found in the prior art, the nature of the problem, or the knowledge of a PHOSITA. See, e.g., In re Rouffet, 149 F.3d 1350, 1355-56 (Fed. Cir. 1998) (explaining the TSM test); In re Bergel, 292 F.2d 955, 956-57 (C.C.P.A. 1961) ("The mere fact that it is possible to find two isolated disclosures which might be combined in such a way to produce a new compound does not necessarily render such production obvious unless the art also contains something to suggest the desirability of the proposed combination."). The KSR Court held that the Federal Circuit's rigid application of the TSM test is inconsistent with the "expansive and flexible" approach to nonobviousness set forth in prior precedent. KSR, 550 U.S. at 415 (citing Graham v. John Deere Co., 383 U.S. 1, 12, 17, 18 (1966); Hotchkiss v. Greenwood, 52 U.S. (11 How.) 248 (1850)).
317. See, e.g., Aventis Pharma Deutschland GmbH v. Lupin, Ltd., 499 F.3d 1293, 1301-02 (Fed. Cir. 2007) ("Ordinarily, [a PHOSITA] expects a concentrated or purified ingredient to retain the same properties it exhibited in a mixture, and for those properties to be amplified when the ingredient is concentrated or purified.... If it is known how to perform such isolation, doing so 'is likely the product not of innovation but of ordinary skill and common sense.'" (quoting KSR, 550 U.S. at 402-03)); Leapfrog Enters., Inc. v. Fisher-Price, Inc., 485 F.3d 1157, 1161 (Fed. Cir. 2007) (explaining that the obviousness analysis "is not the result of a rigid formula disassociated from the consideration of the facts of a case," but requires a consideration of "the common sense of those skilled in the art").
318. In the predictable arts, for many years the courts adopted the view that a single embodiment was often sufficient to enable a broad claim. See, e.g., Spectra-Physics, Inc. v. Coherent, Inc., 827 F.2d 1524, 1533 (Fed. Cir. 1987) (holding that a patent need only disclose a single embodiment to satisfy enablement); In re Vickers, 141 F.2d 522, 525 (C.C.P.A. 1944) (explaining that an inventor "is generally allowed [broad] claims, when the art permits, which cover more than the specific embodiment shown"). In other words, a PHOSITA in the predictable arts could always fill in gaps omitted from the disclosure.
319. A few years before KSR, the Federal Circuit vitiated the "single embodiment" enablement doctrine and moved toward a more stringent "full scope" enablement standard. See Liebel-Flarsheim Co. v. Medrad, Inc., 481 F.3d 1371, 1379-80 (Fed. Cir. 2007) (determining that a disclosure that enabled an injector with a pressure jacket was insufficient to support a claim that covered injectors with and without pressure jackets); AK Steel Corp. v. Sollac, 344 F.3d 1234, 1244 (Fed. Cir. 2003) (determining that when the claims covered a Type 1 or a Type 2 aluminum coating, yet the patent only described a Type 2 coating, the claims were nonenabled because a PHOSITA could not fill in the gaps without undue experimentation).
320. Several commentators suggest that the new standard is tied to a resurgence of the Federal Circuit's written-description doctrine, which has essentially blurred the line between it and enablement.
321. See, e.g., Mark D. Janis, On Courts Herding Cats: Contending with the "Written Description" Requirement (and Other Unruly Patent Disclosure Doctrines), 2 WASH. U. J.L. & POL'Y 55, 62-63 (2000) (contending that "neither the Federal Circuit nor the C.C.P.A. has ever articulated a persuasive rationale for distinguishing the written description requirement from the enablement requirement").
322. Cf. LizardTech, Inc. v. Earth Res. Mapping, Inc., 424 F.3d 1336, 1344-45 (Fed. Cir. 2005) (observing that the two disclosure requirements are "closely related" and "usually rise and fall together").
323. For instance, like technical journals, patents show the state of technology, set forth what others have already achieved, and provide technical information about procedures that others then need not repeat.
324. THOMAS T. GORDON & ARTHUR S. COOKFAIR, PATENT FUNDAMENTALS FOR SCIENTISTS AND ENGINEERS 51 (2d ed. 2000).
325. In re LeGrice, 301 F.2d 929, 939 (C.C.P.A. 1962).
326. See Jeanne C. Fromer, Patent Disclosure, 94 IOWA L. REV. 539, 554 (2009) ("Much of the information contained in-or that ought to be in-patents is not published elsewhere.").
327. Esteban Burrone & Guriqbal Singh Jaiya, Intellectual Property (IP) Rights and Innovation in Small and Medium-Sized Enterprises 3 (n.d.) (unpublished manuscript), available at http://www.wipo.int/sme/en/documents/pdf/iprs_innovation.pdf ("It has been estimated that patent documents contain 70% of the world's accumulated technical knowledge and that most of the information contained in patent documents is either never published elsewhere or is first disclosed through the publication of the patent application.").
328. It is also true that "in many ways, a scientific publication and the patent document share similar goals-namely to disclose something novel, to teach fellow artisans how to replicate the invention or discovery, and to spur further innovation in the field.".
329. See Wesley M. Cohen, Akira Goto, Akiya Nagata, Richard R. Nelson & John P. Walsh, R&D Spillovers, Patents and the Incentives to Innovate in Japan and the United States, 31 RES. POL'Y 1349, 1362-64 (2002) (presenting empirical research showing that among information sources for diffusing research and development in the United States, patents rank third behind publications and informal information exchange).
330. Several commentators have speculated as to why this is so.
331. Note, The Disclosure Function of the Patent System (or Lack Thereof), 118 HARV. L. REV. 2007, 2025 (2005).
332. (Quoting Competition and Intellectual Property Law and Policy in the Knowledge-Based Economy: Hearing Before the Fed. Trade Comm'n 53 (Mar. 20, 2002) (statement of Daniel McCurdy), available at http://www.ftc.gov/opp/intellect/020320trans.pdf).
333. This is true, at least in part, because an inventor need not create a working embodiment or engage in any experimentation before obtaining the patent.
334. Rather, an inventor can describe an invention with fictitious, constructed examples. And if these examples lack sufficient detail, there is a presumption that a PHOSITA can rely on knowledge in the field to fill in the missing information.
335. In sum, a disclosure that cannot teach a PHOSITA how to practice the invention has little substantive value.
336. See Mark A. Lemley, Ignoring Patents, 2008 MICH. ST. L. REV. 19, 22 n.16 (2008) ("[R]esearch suggests that scientists don't in fact gain much of their knowledge from patents, turning instead to other sources.").
337. See, e.g., Daniel C. Munson, The Patent-Trade Secret Decision: An Industrial Perspective, 78 J. PAT. & TRADEMARK OFF. SOC'Y 689, 713-14 (1996) (observing that chemical patents "tend to be shrouded in chemical nomenclature," which makes them hard to comprehend).
338. 35 U.S.C. § 112, ¶ 1 (2006).
339. Notwithstanding the disclosure requirements of § 112, many patentees adopt the view that the written description does not define the invention but rather provides examples or embodiments of the invention. Rather than use language that explicitly describes what the invention is, for instance, a savvy drafter would say something like, "In an embodiment, one aspect of the invention relates to....".
340. See George F. Wheeler, Creative Claim Drafting: Claim Drafting Strategies, Specification Preparation, and Prosecution Tactics, 3 J. MARSHALL REV. INTELL. PROP. L. 34, 43 (2003) (advising patent claim drafters to couch specific inventions in the broadest manner possible).
341. The U.S. patent system uses a peripheral claiming regime in which claim language sets forth the metes and bounds of the invention, like a deed to real property. See 35 U.S.C. § 112, ¶ 2 ("The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention."). Perhaps not surprisingly, patentees exploit the inherent indeterminacy of language to maximize claim scope by deliberately building ambiguity into the patent document.
342. Clarisa Long, Information Costs in Patent and Copyright, 90 VA. L. REV. 465, 542 & n.187 (2004).
343. See also R. Carl Moy, Subjecting Rembrandt to the Rule of Law: Rule-Based Solutions for Determining the Patentability of Business Methods, 28 WM. MITCHELL L. REV. 1047, 1082 (2002) ("[P]eripheral claiming imposes no inherent limit on the level of abstraction that the patentee is able to use in the claim.").
344. A continuation application is a second application for the same invention disclosed in a parent (original) application that is filed before the parent application either issues as a patent or becomes abandoned. 35 U.S.C. § 120. It has the identical written description as the parent and enjoys the benefit of the parent's earlier filing date. Id. Applicants file continuation applications for many reasons. For example, an applicant may decide to prosecute a parent application with narrow claims (which will issue relatively quickly) and then prosecute broader claims in the continuation application.
345. See ROBERT P. MERGES, PETER S. MENELL & MARK A. LEMLEY, INTELLECTUAL PROPERTY IN THE NEW TECHNOLOGICAL AGE 161-62 (4th ed. 2006) (describing continuation applications, as well as the strategies and benefits associated with them).
346. An applicant can use this strategy "to gain advantages over competitors by waiting to see what product the competitor will make, and then drafting patent claims specifically designed to cover that product.".
347. Mark A. Lemley & Kimberly A. Moore, Ending Abuse of Patent Continuations, 84 B.U.L. REV. 63, 65 (2004).
348. See also EDWARD F. O'CONNOR, INTELLECTUAL PROPERTY LAW AND LITIGATION 116-17 (2d ed. 2003) (arguing that continuation practice gives patentees considerable flexibility to craft claims directed to specific products).
349. Upon filing, an applicant cannot amend the disclosure to introduce new matter into the application. 35 U.S.C. § 132(a) ("No amendment shall introduce new matter into the disclosure of the invention."); 37 C.F.R. § 1.121(f) (2009) ("No amendment may introduce new matter into the disclosure of an application.").
350. The new-matter prohibition of 35 U.S.C. § 132 and its corollary, the written-description requirement of 35 U.S.C. § 112, ¶ 1, "both serve to ensure that the patent applicant was in full possession of the claimed subject matter on the application filing date." TurboCare Div. of Demag Delaval Turbomachinery Corp. v. Gen. Elec. Co., 264 F.3d 1111, 1118 (Fed. Cir. 2001).
351. When a patentee discloses more than he or she enables for § 112 purposes, that subject matter can nonetheless be asserted as prior art against subsequent inventors, at which time it will enjoy a presumption of enablement.
352. See Bonito Boats, Inc. v. Thunder Craft Boats, Inc., 489 U.S. 141, 151 (1989) ("[T]he ultimate goal of the patent system is to bring new designs and technologies into the public domain through disclosure."); see also Aronson v. Quick Point Pencil Co., 440 U.S. 257, 262 (1979) (noting that one goal of patent law is "[to] promote[] disclosure of inventions to stimulate further innovation"). This goal emanates from the Intellectual Property Clause of the Constitution: "To promote the Progress of Science and useful Arts, by securing for limited Times to Authors and Inventors the exclusive Right to their respective Writings and Discoveries." U.S. CONST. art. I, § 8, cl. 8; see also Eldred v. Ashcroft, 537 U.S. 186, 223 (2003) (Stevens, J., dissenting) (noting that the "ultimate purpose" of the patent grant is to "promot[e] the 'Progress of Science and useful Arts' by guaranteeing that those innovations will enter the public domain as soon as the period of exclusivity expires") (quoting U.S. CONST. art. I, § 8, cl. 8).
353. MICHAEL A. GOLLIN, DRIVING INNOVATION 11 (2008).
354. F. Scott Kieff, The Case for Registering Patents and the Law and Economics of Present Patent-Obtaining Rules, 45 B.C.L. REV. 55, 61 (2003) ("The patent system in this country has generally been seen as offering inventors an incentive to do something they might not otherwise do-for example, invent, disclose, commercialize, or design around.".
355. (Citing DONALD S. CHISUM, CRAIG ALLEN NARD, HERBERT F. SCHWARTZ, PAULINE NEWMAN & F. SCOTT KIEFF, PRINCIPLES OF PATENT LAW 58-90 (2d ed. 2001) (exploring diverse incentive theories of the patent system))).
356. See also State Indus., Inc. v. A.O. Smith Corp., 751 F.2d 1226, 1236 (Fed. Cir. 1985) ("One of the benefits of a patent system is its so-called 'negative incentive' to 'design around' a competitor's products, even when they are patented, thus bringing a steady flow of innovations to the marketplace.").
357. A subsequent inventor can possibly obtain a new-use patent, however.
358. Rejecting a claim to X will essentially foreclose the opportunity to fully exploit the compound.
359. Cf. Nuno Pires de Carvalho, The Problem of Gene Patents, 3 WASH. U. GLOB. STUD. L. REV. 701, 735 (2004) (arguing that inventions that are never exploited, and thus that never reach the market, are economically irrelevant).
360. In addition, if the subsequent inventor abandons the patent application, the public will not gain access to the presumably enabling technical information disclosed in it. That the subsequent inventor will disclose the information in another medium is also unlikely.
361. Turning back to the availability of a new-use patent, most would agree that it would provide less economic or technical benefit than a (broader) patent covering the compound itself.
362. See also Howard F. Chang, Patent Scope, Antitrust Policy, and Cumulative Innovation, 26 RAND J. ECON. 34, 52 (1995) (arguing that narrow patent protection inhibits the disclosure and dissemination of information useful to others).
363. Patent law "seeks to foster and reward invention" with the hope that the disclosure will "stimulate further innovation and... permit the public to practice the invention once the patent expires." Aronson v. Quick Point Pencil Co., 440 U.S. 257, 262 (1979); see also Paulik v. Rizkalla, 760 F.2d 1270, 1276 (Fed. Cir. 1985) (en banc) ("The reason for the patent system is to encourage innovation and its fruits: new jobs and new industries, new consumer goods and trade benefits."). But "[e]ven if no incentive is required to produce an innovation, providing a reward after the creative act encourages [the inventor] and others to do more creative work in the future.".
364. "Production goals are the number of specific actions and decisions that patent examiners must make about patent applications they review during a 2-week period.".
365. U.S. GOV'T ACCOUNTABILITY OFFICE, GAO-07-1102, U.S. PATENT AND TRADEMARK OFFICE: HIRING EFFORTS ARE NOT SUFFICIENT TO REDUCE THE PATENT APPLICATION BACKLOG 2 (2007), available at http://www.gao.gov/new.items/d071102.pdf.
366. Implicit in these goals is an estimate of the time it takes to review a patent application.
367. The amount of time the Patent Office allots for an examiner to dispose of a case depends on factors like seniority and the technology involved.
368. Time estimates vary. Compare John R. Thomas, Collusion and Collective Action in the Patent System: A Proposal for Patent Bounties, 2001 U. ILL. L. REV. 305, 314 (estimating a sixteen-to seventeen-hour average time allotment).
369. With Mark A. Lemley, Rational Ignorance at the Patent Office, 95 NW. U. L. REV. 1495, 1500 n.19 (2001) (aggregating time estimates, which range from eight to thirty-two hours, depending on the technology).
370. An Office Action is an official communication from the Patent Office stating the examiner's position on patentability and the basis for any claim rejections. See 37 C.F.R. § 1.104(b) (2009) (describing the nature and content of the Office Action).
371. Under the status quo, a savvy examiner who wants to maximize monetary and performance rewards should reject the application once, issue one Office Action, and then allow the application.
372. See Nikolas J. Uhlir, Note, Throwing a Wrench in the System: Size-Dependent Properties, Inherency, and Nanotech Patent Applications, 16 FED. CIR. B.J. 327, 340 n.88 (2007) (explaining the compensation system and the incentives it gives to examiners).
373. See ANTHONY L. MIELE, PATENT STRATEGY 97-98 (2001) (discussing the examiner's concerns and incentives).
374. Although allowances and final rejections both count toward an examiner's production goals, several commentators argue that the incentive system favors allowance.
375. Thus, the skewed incentives of the current regime "make it easier and more desirable for examiners to grant patents rather than reject them.".
376. Joseph Farrell & Robert P. Merges, Incentives to Challenge and Defend Patents: Why Litigation Won't Reliably Fix Patent Office Errors and Why Administrative Patent Review Might Help, 19 BERKELEY TECH. L.J. 943, 945 (2004).
377. Savvy applicants are aware of the skewed incentives.
378. The current time estimates and quotas were established in 1976. Despite criticism over the past decade, Patent Office officials have not updated them to reflect increasing technical complexity, and those officials are insensitive to the number of pages or claims in an application.
379. Finally, in response to the GAO Report, the Patent Office is seeking to reevaluate its production-management system.
380. Patent Examiner Production Goals Study, U.S. PATENT & TRADEMARK OFF. (May 15, 2009), http://www.uspto.gov/web/offices/ac/comp/proc/pgs/pgshom.htm.
381. See also Stephen Barr, Backlog, Quotas Overwhelm Patent Examiners, WASH. POST, Oct. 8, 2007, at D1 (discussing the GAO Report and comments from the Director of the U.S. Patent and Trademark Office).
382. As one commentator explains, under the current system examiners have a monetary disincentive to engage in an extensive prior art search because "doing so means that they have more work to do with less pay than they would receive had they not searched for the art and simply issued the patent.".
383. David Hricik, Aerial Boundaries: The Duty of Candor as a Limitation on the Duty of Patent Practitioners to Advocate for Maximum Patent Coverage, 44 S. TEX. L. REV. 205, 228 (2002).
384. See Mark A. Lemley & Bhaven Sampat, Is the Patent Office a Rubber Stamp?, 58 EMORY L.J. 181, 181-82 (2008) (exploring criticisms).
385. Michael Risch, The Failure of Public Notice in Patent Prosecution, 21 HARV. J.L. & TECH. 179, 196 (2007) ("A high-quality prior art search is difficult because of resource and time limitations.").
386. One reform goal, stated in the Introduction to the Patent Reform Act of 2007 as proposed in the Senate, was "to improve patent quality and the patent application process." S. REP. No. 110-259, pt. 1, at 5 (2008).
387. Improving patent examination and patent quality are now priorities in the Patent Office.
388. This is also a potential criticism of the disclosure-dedication rule.
389. See Johnson & Johnston Assocs. Inc. v. R.E. Serv. Co., 285 F.3d 1046, 1064-72 (Fed. Cir. 2002) (en banc) (Newman, J., dissenting) (per curiam) (explaining that the disclosure- dedication rule imposes legal obstacles to the disclosure of scientific information and that those obstacles will deter innovation).
390. It currently appears that patents are not a dominant channel of information flow.
391. This is unfortunate because most of the information disclosed in patents is not disclosed in another medium.
392. Unclaimed subject matter is not subject to the disclosure requirements of § 112.