Getting smaller: What will enablement of nanotechnology require?

Nanotechnology Law and Business

Volumn 3, Issue 2, 2006, Pages 145-157

  Schwaller, Melissa D ^a   Goel, Gaurav ^a  

^a Winstead Sechrest and Minick PC ^*

Author keywords

[No Author keywords available]

Indexed keywords

BIOTECHNOLOGY; LAWS AND LEGISLATION; PATENTS AND INVENTIONS; SEMICONDUCTOR MATERIALS;

ENABLEMENT REQUIREMENTS; NANOTECHNOLOGY-RELATED TECHNOLOGIES;

NANOTECHNOLOGY;

EID: 33750339839     PISSN: 15462080     EISSN: 15462080     Source Type: Trade Journal    
DOI: None     Document Type: Article

References (150)

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3. Id.
4. 35 U.S.C. § 101.
5. Patent & Trademark Ofc., What Can Be Patented, http://www.uspto.gov/ web/offices/pac/doc/general/what.htm (last visited Apr. 17, 2006).
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7. U.S. Pat. No. 5,424,054 (filed May 21, 1993).
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10. Iona Kaiser, Nanotechnology Patents - Will Small-Scale Science Pose Big Challenges For Applicants And Patent Office?, 4 BAKER BOTTS L.L.P. INTELLECTUAL PROPERTY REPORT (Apr. 15, 2004), http://www.imakenews.com/bakerbotts/ e_article000246821.cfm (last visited Apr. 17, 2006).
11. Kaiser, supra note 7.
12. The PTO recently developed a nanotechnology cross-reference digest (designated as class 977/dig.1) to aid in searching nanotechnology prior art across the PTO's multiple technology centers, and to provide a more comprehensive nanotechnology classification schedule than existed previously. Patent & Trademark Ofc., New Cross-Reference Digest for Nanotechnology, http://www.uspto.gov/web/patents/biochempharm/crossref.htm (last visited Apr. 17, 2006) (stating that "[e]stablishing this nanotechnology cross-reference digest is the first step in a multi-phase nanotechnology classification project and will serve the following purposes, facilitate the searching of prior art related to Nanotechnology, function as a collection of issued U.S. patents and published pre-grant patent applications relating to nanotechnology across the technology centers and assist in the development of an expanded, more comprehensive, nanotechnology cross-reference art collection classification schedule.").
13. Id.;
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16. U.S. Pat. No. 4,663,230 (filed Dec. 6, 1984).
17. U.S. Pat. No. 5,424,054 (filed May 21, 1993).
18. Kaiser, supra note 7 (stating "[s]uch fears may rest on the theory that Examiners in discrete technology areas (say, electronics) may lack the necessary trans-disciplinary knowledge and experience in other fields (such as materials science or chemistry) implicated by the often-complex combination of sophisticated synthesis and materials processing techniques necessary to obtain and manipulate nano-scale devices having electrically - and otherwise - useful properties, and that such Examiners may thus allow claims broader than are justified by the prior art as a whole or by the enabling disclosure of the applicant.").
19. See id.
20. Id.
21. 35 U.S.C. § 282; Am. Hoist & Derrick Co. v. Sowa & Sons, Inc., 725 F.2d 1350, 1360 (Fed. Cir. 1984).
22. 35 U.S.C. § 112, ¶ 1.
23. Id.
24. Id.
25. In re Wands, 858 F.2d 731, 737 (Fed. Cir. 1988).
26. Id. While In re Wands is directed to immunoassay methods for the detection of hepatitis B surface antigen using high affinity monoclonal antibodies of the IgM isotype, the same factors are applied to all technologies and all categories of patentable subject matter. KENNETH J. BURCHFIEL, BIOTECHNOLOGY AND THE FEDERAL CIRCUIT, 173 (The Bureau of National Affairs, Inc. 1997).
27. U.S. PAT. & TRADEMARK OFFICE, U.S. DEP'T OF COMMERCE, MANUAL OF PATENT EXAMINING PROCEDURE, 2164.08 (8th ed. 2001, 4th rev. 2005) [hereinafter MPEP].
28. Id.
29. W. at 2164.05a.
30. Id.
31. Id.
32. Id.
33. MPEP, supra note 23, at 2164.03.
34. Id.
35. Id. (citing In re Fisher, 427 F.2d 833, 839 (C.C.P.A. 1970)).
36. Id. at 2164.02.
37. Id.
38. MPEP, supra note 23, at 2164.06;
39. In re Wands, 858 F.2d at 737 (citing In re Angstadt, 537 F.2d 489, 502-04 (C.C.P.A. 1976))."
40. MPEP, supra note 23, at 2164.06.
41. In re Wands, 858 F.2d at 737, 740 (stating, "It is improper to conclude that a disclosure is not enabling based on an analysis of only one of the above factors while ignoring one or more of the others.").
42. Id.
43. Id.
44. U.N. CONVENTION ON BIOLOGICAL DIVERSITY, Art. 2 (2005), available at http://www.biodiv.org/convention/articles.asp (last visited Apr. 17, 2006).
45. Press Release, Biotechnology Industry Organization, BIO 2004: World's Largest Biotech Event Goes Back to Where It All Began, San Francisco (Mar. 23, 2004), available at http://www.bio.org/events/2004/media/pr2.asp?id=2004_0323_01 (last visited Apr. 17, 2006).
46. 447 U.S. 303 (1980);
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48. Vivek Koppikar, Stephen B. Maebius & J. Steven Rutt, Current Trends in Nanotech Patents: A View From Inside the Patent Office, 1 NANOTECH. L. & BUS. 24 (2004) (stating that "[i]n biotechnology, examiners and courts have used the enablement doctrine to narrow the scope of overly broad claims [in In re Goodman and Enzo]. A typical rejection states that the scope of the claim is too broad in relation to the number of examples provided in the specification, given the level of unpredictability that existed in the area of the invention at the time the application was filed.").
49. Id.
50. Id.
51. In re Fisher, 427 F.2d 833 (C.C.P.A. 1970).
52. Id.
53. Id. at 839.
54. Id.
55. Id. ("In cases involving predictable factors, such as mechanical or electrical elements, a single embodiment provides broad enablement in the sense that, once imagined, other embodiments can be made without difficulty and their performance characteristics predicted by resort to known scientific laws. In cases involving unpredictable factors, such as most chemical reactions and physiological activity, the scope of enablement obviously varies inversely with the degree of unpredictability of the factors involved.").
56. Amgen, Inc. v. Chugai Pharmaceutical Co., 927 F.2d 1200 (Fed. Cir.), cert. denied, 112 S. Ct. 169 (1991).
57. Id.;
58. BURCHFIEL, supra note 22, at 192.
59. Amgen, 927 F.2d at 1213.
60. Id.
61. In re Vaeck, 947 F.2d 488 (Fed. Cir. 1991);
62. BURCHFIEL, supra note 22, at 201.
63. Vaeck, 947 F.2d at 489.
64. Id. at 495.
65. Id. at 496.
66. In re Wright, 999 F.2d 1557 (Fed. Cir. 1993);
67. BURCHFIEL, supra note 22, at 201.
68. Wright, 999 F.2d at 1559;
69. BURCHFIEL, supra note 22, at 201.
70. Wright, 999 F.2d at 1561;
71. BURCHFIEL, supra note 22, at 201.
72. In re Goodman, 11 F.3d 1046 (Fed. Cir. 1993).
73. Id. at at 1050;
74. BURCHFIEL, supra note 22, at 201.
75. Genentech, Inc. v. Novo Nordisk, 108 F.3d 1361, (Fed. Cir. 1997), cert. denied, 522 U.S. 963 (1997);
76. see Andrea G. Reister, Enablement & Written Description: Friend or Foe in Litigation, 804 P.L.I./PAT. 607 (2004).
77. Genentech, 108 F.3d at 1367-68.
78. Id. at 1367-68.
79. Johns Hopkins University v. Cellpro, Inc., 152 F.3d 1342 (Fed. Cir. 1998).
80. Johns Hopkins University, 152 F.3d at 1360 n.26.
81. Enzo Biochem, Inc. v. Calgene, Inc., 188 F.3d 1362 (Fed. Cir. 1999);
82. Reister, supra note 71.
83. Enzo Biochem, 188 F.3d at 1369.
84. BURCHFIEL, supra note 22, at 62.
85. Enzo Biochem, 188 F.3d at 1374, 1377.
86. Id. at 1372;
87. DONALD S. CHISUM, CHISUM ON PATENTS, 7.03[4][d] (2005).
88. Amgen Inc. v. Hoechst Marion Roussel Inc., 314 F.3d 1313 (Fed. Cir. 2003).
89. Id. at 1336.
90. Id. at 1335.
91. Id. (citations omitted).
92. Chiron Corp. v. Genentech, Inc. 363 F.3d 1247 (Fed. Cir. 2004);
93. Reister, supra note 71.
94. Id. at 1254.
95. Amir Naini, Convergent Technologies and Divergent Patent Validity Doctrines: Obviousness and Disclosure Analyses in Software and Biotechnology, 86 J. OF THE PAT. & TRADEMARK OFF. 541, 544-45 (2004).
96. BURCHFIEL, supra note 22, at 195.
97. Lawrence M. Sung, Stranger in A Strange Land: Biotechnology and the Federal Circuit, 2 WASH. UNIV. J. OF L. & POL'Y 167, 198 (2000).
98. See MOORE'S LAW, WIKIPEDIA, http://en.wikipedia.org/wiki/Moore's_law (last visited Apr. 17, 2006).
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100. Rosemarie Ham Ziedonis, Patent Litigation in the U.S. Semiconductor Industry, PATENTS IN THE KNOWLEDGE-BASED ECONOMY 180, 189 (2003).
101. Id. at 190.
102. Harris Corp. v. IXYS Corp., 114 F.3d 1149 (Fed. Cir. 1997).
103. Id. at 1150.
104. Id. at 1151.
105. Id. at 1153.
106. Id. at 1156.
107. Id. at 1156.
108. Bruning v. Hirose, 161 F.3d 681 (Fed. Cir. 1998).
109. Id. at 682.
110. Id. at 683.
111. Id. at 684.
112. Id.
113. Id. at 686.
114. Durel Corp. v. Osram Sylvania, Inc., 256 F.3d 1298 (Fed. Cir. 2001).
115. Id. at 1298-99.
116. Id. at 1302.
117. Id. at 1307-08.
118. Id. at 1306.
119. EMI Group North America Inc. v. Cypress Semiconductor Corp., 268 F.3d 1342 (Fed. Cir. 2001).
120. Id. at 1344.
121. Id.
122. Id. at 1345.
123. Id. at 1346.
124. Soitec, S.A. v. Silicon Genesis Corp., 81 Fed. Appx. 734 (Fed. Cir. 2003). While this opinion is non-precedential and should not be cited as a proposition of law, the case reflects the current standard of the enablement test and is a further reflection of the application of the factors as applied to semiconductor devices.
125. Id. at 735.
126. Id. at 738.
127. Id.
128. CFMT, Inc. v. Yieldup Intern. Corp., 349 F.3d 1333 (Fed. Cir. 2003).
129. Id. at 1334-35.
130. Id. at 1337.
131. Id. at 1337-38.
132. Id.
133. Id. at 1338.
134. CFMT, Inc., 349 F.3d at 1338.
135. Id. at 1338-39.
136. Naini, supra note 79, at 543.
137. Id. at 567.
138. U.S. Court of Appeals for the Federal Circuit, About the Court, http://www.fedcir.gov/about.html (last visited Apr. 17, 2006).
139. Bruning, 161 F.3d at 686.
140. Union Pacific Resources v. Chesapeake Energy, 236 F.3d 684, 690 (Fed. Cir. 2001).
141. Naini, supra note 79, at 551.
142. Joff Wild, Nanotech Patents - The Next Big Thing, THOMSON SCIENTIFIC (Aug. 2002), http://scientific.thomson.com/free/ipmatters/nanotech/8180000 (last visited Apr. 17, 2006).
143. Id.
144. Koppikar et al., supra note 42.
145. Id.
146. Andrew S. Baluch, Leon Radomsky & Stephen B. Maebius, In re Kumar - The First Nanotech Patent Case in the Federal Circuit, 2 NANOTECH. L. & BUS. 342 (2005).
147. In re Kumar, 418 F.3d 1361, 1369 (Fed. Cir. 2005).
148. Id. at 1361.
149. Koppikar et al., supra note 42.;
150. Commercializing Nanobio Products: An Overview of Legal Issues and Regulations, Morrison & Foerster, L.L.P., supra note 1 (stating, "A similar situation was seen in growth of the biotech industry, where there was initially little patent litigation but this was followed by extensive litigation as biotechnology products became commercially successful.").