Patent Law in Biotechnology, Chemicals & Pharmaceuticals

Patent Law in Biotechnology, Chemicals & Pharmaceuticals HAROLD C WEGNER

M stockton

press

©Harold C. Wegner, 1992

Softcover reprint ofthe hardcover 1st edition 1992 978-0-333-57383-9

All rights reserved. No part of this publication may be reproduced or transmitted, in any form or by any means, without permission.

Published in the United States and Canada by STOCKTON PRESS, 1992 257 Park Avenue South, New York, N.Y. 10010, USA

ISBN 978-1-56159-048-3

First published in the United Kingdom by MACMILLAN PUBLISHERS LTD, 1992 Distributed by Globe Book Services Ltd Brunei Road, Houndmills, Basingstoke, Hants RG21 2XS, England

ISBN 978-1-349-21960-5 ISBN 978-1-349-21958-2 (eBook) DOI 10.1007/978-1-349-21958-2

A catalogue record for this book is available from The British Library.

SUMMARY OF CONTENTS

PREFACE .............................................. v DETAILED TABLE OF CONTENTS . . . . . . . . . . . . . . . . . . . . . . . . .. lX

§ 1. INTRODUCTION .............................................. 1 § 10. TRADE SECRETS ............................................ 7 § 20. PATENT OVERVIEW .......................................... 29 § 40. THE PARIS CONVENTION ...................................... 39 § 60. OTHER TREATIES. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 44 § 70. PATENT PROCUREMENT STRATEGIES. . . . . . . . . . . . . . . . . . . . . . . . . . . .. 46 § 84. DRAFTING THE PATENT APPLICATION. . . . . . . . . . . . . . . . . . . . . . . . . . . .. 53

§ 100. PATENT-ELIGffiLE SUBJECT MATTER ................. 63 § 110. NOVELTY (ANTICIPATION) .......................... 70

§ 130. FIRST INVENTOR SYSTEM ...................................... 89 § 140. PRIORITY, EARLIER PATENT APPLICATION. . . . . . . . . . . . . . . . . . . . . . . .. 94 § 147. PRIORITY, PROOF OF EARLY DATE OF INVENTION. . . . . . . . . . . . . . . .. 100 § 150. INTERFERENCE PROCEDURES ................................ 107 § 160. INTERFERENCE STRATEGIES. . ... . . .... . . .... . . . . . . . . . .. . .. . .. 115

§ 200. OBVIOUSNESS .................................... 119 § 230. HOMOLOGS, ISOMERS AND ANALOGS ........................... 156 § 250. PROVING A DIFFERENCE IN PROPERTIES ......................... 161 § 260. METHOD OF USE CLAIM OBVIOUSNESS ISSUES . . . . . . . . . . . . . . . . . . . . 176 § 270. METHOD OF MAKING OBVIOUSNESS ISSUES ...................... 190 § 280. PRODUCT-BY-PROCESS CLAIMS ................................ 204 § 284. PURITY AND ACTIVITY LEVEL LIMITATIONS ........................ 208 § 290. JEPSON AND OTHER PRIOR ART "ADMISSIONS" .................... 210

§ 300. CLAIMS AND THEIR INTERPRETATION. . . . . . . . . . . . . .. 216 § 310. CLAIM STRUCTURE .......................................... 223 § 320. "MEANS" LIMITATIONS ........................................ 233 § 330. DETERMINING THE LITERAL SCOPE OF THE CLAIM ................. 236

§ 350. INFRINGING ACTS .............................................. 253 § 360. INFRINGEMENT DETERMINATION ............................... 295 § 370. THE DOCTRINE OF EQUIVALENTS ............................... 305 § 380. FILE WRAPPER (PROSECUTION HISTORY) ESTOPPEL ................ 316 § 390. THE REVERSE DOCTRINE OF EQUIVALENTS ....................... 324

§ 400. DISCLOSURE REQUIREMENTS ...................... 332 § 410. THE ''WRITTEN DESCRIPTION" REQUIREMENT ...................... 338 § 420. ENABLEMENT, "HOW TO MAKE" ................................. 349 § 430. ENABLEMENT, "HOW TO USE" .................................. 356 § 450. THE "BEST MODE CONTEMPLATED' •• " ......................... 372 § 460. BIOTECHNOLOGY DEPOSITS .................................. 392

§ 500. DUTY OF DISCLOSURE ............................ 423 § 530. DOUBLE PATENTING .............................. 439 § 540. RESTRICTION PRACTICE . . . . . . . . . . . . . . . . . . . . . . . . . .. 445

§ 550. ELECTION OF SPECIES ....................................... 448 § 560. MARKUSH-ELECTION INTERFACE ............................... 450 § 570. INTERNATIONAL UNITY STANDARDS ............................. 471

§ 580. INTERNATIONAL PRACTICE DIFFERENCES ........... 475

TABLE OF CASES ...................................... 483 INDEX ............................................... 499

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PREFACE

Businessmen, scientists and international and domestic patent practitioners having a central interest in patents relating to biotechnology and chemical patenting in the United States are presented with a comprehensive text on patent law specially tailored to these technologies. A comparative focus is provided which serves to familiarize Americans with some of the differences they need to address in gaining a global patent portfolio, while at the same time providing the Asian or European patent expert with a more user-friendly interface to how parallel issues are treated in the United States.

A dilemma facing anyone without a formal common law legal training who seeks to understand any field of U.S. law is the need to grasp the significance of "case law", an amorphous body of legal knowledge that can be distilled only by reading the opinions of the courts. Particularly Asian and Continental European readers often do not have access to entire reports, and even where they do, the raw case reports are chock full of legalese and procedural issues that obfuscate the key substantive patent law points for which they are cited. Therefore, in addition to naming several hundred cases, tabulated in a Table of Cases (page 483), more important may be the more than seventy-five case reports. Each of these reports focuses on substantive patent issues, without a dry and hypertechnical recitation of facts (which instead are summarized by the author); the often lengthy discussions on procedural issues only of interest to the litigators have been deleted. For the scientist every effort has been made to "delegalize" the text of opinions.

The international patent expert as well as Americans interested in foreign practice will find it most useful to start with the treatment of International Practice Differences (§§ 580-588). This provides a useful frame of reference to focus on the points of difference between the "home country" practice of the reader in Europe or Asia and that of the United States.

For the Wall Street lawyer or international executive concerned about a particular patent in a portfolio as basis for an exclusive marketing position, the logical starting point is the determination of what exactly are the metes and bounds of the patent; see Claims and Their Interpretation (§ 300). The next step is to consider Infringing Acts (§ 350). Strategies for patent procurement are considered under Patent Procurement Strategies (§ 70).

As a reference tool for the expert who may only occassionally wish to turn to various sources when a case of importance requires an exhaustive search of the patent literature, special consideration has been given for such readers. Several quick pathways to the appropriate place in the text are provided, anyone of which should work for most situations. This redundancy provides a backup systemf for a quick search of this text. Because of the comparative focus of this book, perhaps some new solutions will be suggested based upon the prior treatment of such issues in Europe or Japan. Those wishing immediate access to treat specific issues will find three parallel ways to proceed. First, there is a very detailed Table of Contents immediately following this Preface, a listing of the main cases cited in this book in the Table of Cases (page 438), and an

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extensive index at the end of the book. By providing a very detailed Table of Contents, with some of the material being broken into units of even as little as a paragraph, this road to finding the relevant text should prove the easiest way to track a specific subject. Of course, if the key case is known to the reader, the Table of Cases provides another approach. As a failsafe key to the text, the Index comprises more than 700 individual entries.

No matter who the reader may be, this book necessarily reflects the views of the author and is not intended as a substitute for competent legal advice. Particularly for those outside the legal profession, this book is designed as a guide to introduce issues so that the individual will be better able to understand them and work through his professional counsel.

In the academic community, recognition is due to the several pioneers in the field of patents as well as to those who have helped to promote the study of patents, including Professors Martin Adelman, Donald W. Banner, Friedrich­Karl Beier, Noel J. Byrne, Donald S. Chisum, William Cornish, Gerald Dworkin, Rebecca S. Eisenberg, Jack H. Friedenthal, Robert P. Merges, Nobuhiro Nakayama, Paul Salmon, Pamela Samuelson, Teresa M. Schwartz and Zentaro Kitagawa. The author owes a word of special thanks to Prof. Beier (Geschiiftsfiihrender Direktor of the Max-Planck-Institut fUr Auslandisches und Internationales Patent-, Urheber- und Wettbewerbsrecht while the author was Wiss. Mitarbeiter), Dr. Kitagawa (in 1992 celebrating his sixtieth year and who fifteen years ago invited the Author to be Kenshuin at the Kyoto University Law Faculty), Deans Friedenthal and Schwartz (who invited the author to his present position at the National Law Center) and Prof. Banner (former Director of the Intellectual Property Law Program who brought the author to the National Law Center).

This book is a revision of several works that may be traced back to materials used over a period of six years when the author was Adjunct Professor of Law at the Georgetown University Law Center. The constructive criticism from the approximately 300 students who used these revised materials yielded text that formed a core for the present work used at the National Law Center since 1989, the start of the author's affiliation with the George Washington University. First, a text was prepared for a graduate course, Comparative and International Patent law. Thereafter, an extensive set of domestic case materials designed for a second graduate course, Biotech and Chemical Patents, was merged into what became the first edition of this book.

Concepts" examples and other material may be traced as far back as an international and comparative seminar on chemical and biotechnology patenting just off the "English Garden" in Munich, October 30-31, 1975, that featured Tomatsu Aoyama, George Szabo and Volker Vossius, followed several months later by a two day Japan AIPPI seminar chaired by Shoji Matsui in Tokyo on the occassion of the author's first visit to that city. Since that time, views have been sharpened and shaped and new areas opened for exploration thanks to the many comments, criticisms, questions and papers of participants at various meetings of experts, seminars and bar groups held at Airlee (Va.), Amsterdam, Atlanta, Birmingham (Ala.), Boca Raton, Boston, Brussels, Cambridge (Mass.), Cannes,

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Preface

Carmel, Cerromar Beach, Chicago, Cleveland, Cold Spring Harbor (Long Island), Copenhagen, Dublin, Evanston (111.), Geneva, Gull Lake (Minn.), Kyoto, Mackinac Island, Marco Island, London, Los Angeles, Munich, Nagoya, Naples (Fla.), New Haven, New Orleans, New York City, Osaka, Palm Springs, Palm Desert, Palo Alto, Paris, Perugia, Philadelphia, Pittsburgh, Phoenix, Princeton, Rochester, San Diego, Saw Mill Creek (Ohio), Tokyo, Versailles, Virginia Beach, Washington, D.C., White Sulfur Springs (W. Va.) and Zurich. Among the various writers, speakers and authors (including those expressing a different point of view) who have helped shape an understanding of the law at the several conferences, or in their writings, may be mentioned Shogo Abe, Reid Adler, Tomatsu Aoyama, Robert A. Armitage, Ludwig Bauemer, Heinz Bardehle, David W. Beier, Stephen Bent, Richard E. Bizley, Arpad Bogsch, Margaret A. Boulware, R. Stephen Crespi, Bruce M. Eisen, James F. Haley, Albert P. Halluin, Ryo Iwatani, Takashi Ishida, Eiji Katayama, Kazuo Kamisugi, Walter N. Kirn, Gert Kolle, Kou Kunieda, Elizabeth Lassen, Osamu Kusama, Edward T. Lentz, Akira Mifune, S. Leslie Misrock, Ellsworth H. Mosher, Frithjof E. Mi.iller, Kate Murashige, Ken-ichi Ooya, Jochen Pagenberg, Knud Raffns0e, Nobuo Sasaki, Dr. U. Schatz, Richard A. Schwaab, Yasuo Shibata, George Szabo, Joseph Straus, Kazuaki Takami, Toshihiko Takenaka, Yasuo Tamura, Tetsu Tanabe, Mitsuo Tanaka, Elisabeth Thouret-Lemaitre, Shozo Uemura, Susumu Uchihara, Charles E. Van Horn, Volker Vossius and Yoichiro Yamaguchi.

Herbert I. Cantor, Douglas P. Mueller and William E. Player deserve special recognition. As colleagues in the Washington, D.C. intellectual property boutique styled as Wegner, Cantor, Mueller & Player, their constructive criticisms and suggestions have played a major role in shaping whatever practical insights may be gained from this work.

Harold C. Wegner

McLean, Virginia

January 1992

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DETAILED TABLE OF CONTENTS

OVERVIEW ............................................. 1 § 1. INTRODUCTION § 2. "TO PROMOTE ••• THE USEFUL ARTS" § 3. SOURCES FOR INTERPRETATION OF THE PATENT STATUTE § 4. AGENCY "REGULATIONS" HAVING THE FORCE OF LAW § 4. MANUAL OF PATENT EXAMINING PROCEDURE ("MPEP") § 5. CASE LAW TO INTERPRET STATUTORY PROVISIONS

TRADE SECRETS ........................................ 7 § 10. OVERVIEW § 11. PATENT AND TRADE SECRET PROTECTION FOR 18 MONTHS § 12. PITFALLS OF TRADE SECRET PROTECTION § 13. SECRECY AND THE ROLE OF CONFIDENTIALITY AGREEMENTS § 14. REMEDIES TO ENFORCE TRADE SECRET VIOLATIONS § 15. PATENT LAW NOVELTY IS NOT REQUIRED § 16. DISCOVERY OF THE TRADE SECRET BY THIRD PARTIES § 17. THE QUICK POINT PENCIL CASE § 18. TECHNOLOGY INVOLVING BOTH TRADE SECRETS AND PATENTS

PATENTOVERVIEW ..................................... 29 § 20. INTRODUCTION § 21. STATUTORY SCHEME OF THE PATENT LAW § 22. PATENT-ELIGIBLE INVENTIONS (§ 101) § 23. NOVELTY UNDER THE "FIRST INVENTOR" SYSTEM § 24. OBVIOUSNESS, PATENTABLE DIFFERENCE BEYOND NOVELTY § 25. PRECLUSION OF FOREIGN ACTIVITIES FOR PRIORITY (§ 104) § 26. APPLICATION FILING REQUIREMENTS; OATH (§§ 111,115) § 27. WRITTEN DESCRIPTION, ENABLEMENT, BEST MODE (§ 112, 11) § 28. CLAIMING REQUIREMENTS (§ 112, 112-6) § 29. DRAWINGS (§ 113) § 30. INVENTORSHIP REQURIREMENTS (§§ 116-118) § 31. PARIS CONVENTION PRIORITY (§ 119) § 32. DOMESTIC CONTINUING APPLICATIONS (§ 120) § 33. CONTINUING CASE BASED UPON A PCT PARENT (§ 120; § 365(C» § 34. RESTRICTION; DIVISIONAL APPLICATIONS (§§ 120,121) § 35. THE U.S. PLANT PATENT LAW (§§ 161 - 164) § 36. THE U.S. DESIGN PATENT LAW (§§ 171 - 173)

TIlE PARIS CONVENTION ................................. 39 § 40. STOCKHOLM REVISION OF THE PARIS CONVENTION § 41. FILING DECISIONS BY THE TWELFTH MONTH § 42. "REGULAR NATIONAL FILING" § 43. FORMALITIES OF THE PRIORITY CLAIM § 44. PRIORITIES BASED UPON MORE THAN ONE APPLICATION § 45. NO PRIORITY BASED UPON AN AMENDED APPLICATION § 46. SUPPORT IN THE PRIORITY DOCUMENT § 47. DEFENSIVE PRIORITY PATENT RIGHT TO BAR THIRD PARTIES

OTllER TREATIES ....................................... 44 § SO. INTRODUCTION

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§ 61. THE PATENT COOPERATION TREATY (PCT) § 62. PCT AS BASIS FOR U.S. "NATIONAL STAGE" APPLICATION § 63. PCT "PARENT" FOR CONTINUING U.S. APPLICATION § 64. THE BUDAPEST TREATY § 65. EUROPEAN PATENT CONVENTION § 66. LUXEMBOURG PATENT CONVENTION

PATENT PROCUREMENT STRATEGIES •.••••••••••••.•••••••••.•••••• 46 § 70. INTRODUCTION § 71. LEARNING THE WORLD OF CHEMICAL PATENT EXAMINATION § 72. A GLOBAL PERSPECTIVE § 73. REGULATED PRODUCTS AND SPECIAL CONSIDERATIONS § 74. REGULATED PRODUCTS; LATE COMMERCIAL CANDIDATES § 75. REGULATED PRODUCTS; LITERAL COVERAGE § 76. REGULATED PRODUCTS; DE FACTO FIRST TO FILE § n. TIME LINE FOR FILING AND PROSECUTION DECISIONS § 78. PARIS CONVENTION DEADLINE (t = 12 MOS.) § 79. WORLDWIDE PUBLICATION (t = 18 MOS.) § 80. IDENTIFICATION OF MOST SENIOR-FILED APPLICATIONS § 81. JAPANESE PROTECTION OF OBVIOUS VARIANTS § 82. FINAL DEADLINE FOR CIP'S WITH NEW DEFINITIONS § 83. EARLIEST POSSIBLE CONTINUATION-IN-PART

DRAFTING THE PATENT APPLICATION •••.••.•••••••••.•••.••••..••.. 53 § 84. INTRODUCTION § 85. THE SEVERAL PARTS OF A PATENT APPLICATION § 86. CRAFTING THE CLAIMS FOR THE PATENT APPLICATION § 87. THE MULTIPLE CLAIM SYSTEM § 88. CLAIMS OF DIFFERING CATEGORIES § 89. DIFFERING SCOPE OF PATENTABILITY AROUND THE WORLD § 90. COUNTRY BY COUNlRY CLAIM FORMS § 91. COMBINING RELATED CASES § 92. TAILORED SPECIFICATION SUPPORT § 93. DEFINITIONS TO AVOID MARKUSH PROBLEMS § 94. WORKING EXAMPLES TO SUPPORT THE CLAIMS § 95. DIFFERING BIOTECHNOLOGY STANDARDS § 96. GENE SEQUENCES FOR BIOTECHNOLOGY APPLICATIONS § 97. "BACKGROUND", "OBJECTS" AND "ADVANTAGES· § 98. THE ABSTRACT OF THE DISCLOSURE § 99. APPLICATION FORMALITIES

PATENT-ELIGIBLE SUBJECT MAnER. • • • • • . • • • • • • • • • • . • • • . . • • • • . • •• 63 § 100. INTRODUCTION § 101. THE OPEN DEFINITION OF 35 USC § 101 § 102. "LIVING" PATENT-ELIGIBLE SUBJECT MATTER § 103. PUBLIC ORDER AND MORALITY § 104. "SAME INVENTION" DOUBLE PATENTING § 105. PERMANENT EXPRESSION § 106. THE UTILITY REQUIREMENT OF THE PATENT LAW § 107. INVENTIONS NOT PROVEN SAFE (E.G., FOR HUMANS) § 108. "INCREDIBLE" PHARMACEUTICAL UTILITIES § 109. COMPOUNDS PROVEN TO BE OR STATED TO BE "USEFUL"

NOVELTY (ANTICIPATION) •••.•.•.••.•••••••.••••••••.••••..•••••• 70

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§ 110. INTRODUCTION § 111. STATUTORY NOVELTY UNDER 35 USC § 102 § 112. PRIOR ART FOR OBVIOUSNESS PURPOSES § 113. VARIOUS DATES AND THEIR MEANING § 114. PRIOR ART BEFORE THE APPLICANT'S INVENTION § 115. PRINTED PUBLICATIONS AND PATENTS § 116. THIRD PARTY USE BEFORE THE INVENTION § 117. PRIOR INVENTION OF ANOTHER § 118. SENIOR-FILED PATENT OF ANOTHER § 119. PRIOR ART AS A STATUTORY BAR § 120. DOMESTIC OFFERS OF SALE (EVEN WITHOUT ENABLEMENn § 121. EXPERIMENTAL USE EXCEPTION TO A STATUTORY BAR § 122. ABANDONMENT OF THE INVENTION § 123. PREMATURE PARALLEL PATENTING § 124. DERIVATION § 125. READING THE CLAIM ON THE DISCLOSURE § 126. EARLIER PRIOR ART SPECIES DEFEATS A GENUS § 127. EARLIER GENUS MAY NOT DEFEAT A SPECIES § 128. SPECULATIVE DISCLOSURES § 129. PRIOR ART THAT DOES NOT ENABLE

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FIRST INVENTOR SYSTEM .....•...•..•••••••.•.••..••......••.••.. 89 § 130. INTRODUCTION: THE SEVERAL DATES OF INVENTION § 131. "CONCEPTION" § 132. THE VALUE OF A CONCEPTION DATE § 133. REDUCTION TO PRACTICE § 134. CONSTRUCTIVE REDUCTION TO PRACTICE § 135. CONTINUOUS "DILIGENCE" § 136. FOREIGN ACTIVITY CANNOT ESTABLISH PRIORITY § 137. ABANDONMENT OF THE DATE (NOT THE INVENTION) § 138. DERIVATION TO INDIRECTLY ESTABLISHMENT PRIORITY

PRIORITY BASED UPON AN EARLIER PATENT APPLICATION ..•.....•...... 94 § 140. INTRODUCTION § 141. DOMESTIC PRIORITY § 142. PARIS CONVENTION PRIORITY § 143. DIVISIONAL APPLICATIONS § 144. NEW MATTER WITHOUT LOSING PRIORITY § 145. INHERENT SUPPORT IN THE PARENT § 146. LITTON ACQUIESCENCE

PRIORITY BASED UPON PROOF OF EARLY DATE OF INVENTION ......•.. " 100 § 147. PRIORITY BASED UPON ACTS OUTSIDE THE UNITED STATES § 148. DERIVATION IS EXEMPT FROM § 104 § 149. INTRODUCTION OF EVIDENCE FROM ABROAD

INTERFERENCE PROCEDURES " . . . • • • . • • • . • • . • • . . • • . • . . • . . . . . . . .. 107 § 150. INTRODUCTION § 151. THE "COUNT" -- DEFINITION OF THE CONTEST § 152. INITIATION OF THE INTERFERENCE § 153. DECLARATION: THE OPENING OF THE INTERFERENCE § 154. THE EXAMINER-IN-CHIEF ("EIC") § 155. PRELIMINARY STATEMENTS AND RELIANCE ON DERIVATION

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§ 156. PRELIMINARY MOTIONS § 157. TESTIMONY PERIOD § 158. FINAL HEARING § 159. APPELLATE REVIEW

INTERFERENCE STRATEGIES ••...•••.••..••.••••.••••.••.•....•.• 115 § 160. INRTRODUCTION § 161. SHOULD AN INTERFERENCE BE SOUGHT (OR AVOIDED)? § 162. PROVOKING AN INTERFERENCE § 163. AVOIDING AN INTERFERENCE § 164. AVOIDING A CONFLICT WITH PATENTABLE SUBJECT MAnER § 165. SEnLEMENT § 166. ARBITRATION § 167. INTERFERENCE ESTOPPEL

OBVIOUSNESS. . . . . • • . . . • . . . . . • • . • . • • . . • • • • • • . . . . • . . . . • . . . . • .• 119 § 200. INTRODUCTION § 201. HISTORICAL BACKGROUND § 202. PAPESCH, PRIOR TO GRAHAM § 205. GENESIS OF "STRUCTURAL OBVIOUSNESS" PRACTICE § 206. IS THIS COMPOUND REALLY PRIMA FACIE OBVIOUS? § 207. PRIOR ART-BASED MOTIVATION TO ALTER THE STRUCTURE § 208. REFERENCE WITHOUT UTILITY PROVIDES NO MOTIVATION § 209. SPECIFIC TEACHING OF A SUBSTITUTION § 210. COMMON UTILITY FOR COMBINING REFERENCES § 211. PRIOR ART SUGGESTION TO MODIFY THE ART § 212. RECENT ART THAT TEACHES AWAY § 213.·INTERMEDIATES AS "SUGGESTION" OF A PRODUCT § 214. PROBLEM AS KEY TO THE RELEVANT PRIOR ART § 215. THE PROBLEM FACED AND THE QUESTION OF MOTIVATION § 216. THE LALU CASE § 217. ABSENCE OF MOTIVATION FOR ANY PURPOSE § 218. WRIGHT: MOTIVATION FOR THE APPLICANT'S PURPOSE § 219. THE LAW PRIOR TO THE DILLON PANEL OPINION § 221. THE LILLY CASE: CONSIDERING ALL FACTORS § 222. DILLON, IN BANC, OVERRULING WRIGHT § 223. OPERATIVE METHOD OF MAKING § 224. INGREDIENTS KNOWN FOR OTHER USES § 225. "OBVIOUS TO TRY" REJECTIONS § 226. RESTATED "OBVIOUS TO TRY" REJECTIONS

HOMOLOGS, ISOMERS AND ANALOGS •..••••..•..•.•..•..•...•...... 156 § 230. HOMOLOGY § 231. NON-ADJACENT HOMOLOGS § 232. HOMOLOGS WHICH ARE ALSO ALIPHATIC ISOMERS § 233. THE N-ALKYL SUBSTITUTED AMINES § 234. AROMATIC COMPOUNDS WITH AN ALKYL SUBSTITUENT § 235. ALKYLENE BRIDGING GROUPS § 236. QUATERNARY AMMONIUM DERIVATIVES § 237. RING SIZE AND NUMBER OF RINGS § 238. ISOMERISM § 239. AROMATIC POSITION ISOMERS § 240. ALIPHATIC POSITION ISOMERS § 241. "ANALOGS"

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§ 242. ETHERS § 243. ESTERS OF KNOWN ALCOHOLS § 244. REVERSE ESTERS § 245. RING SYSTEMS DIFFERING WITH DIFFERENT RING ATOMS § 246. AROMATIC VERSUS ALIPHATIC RING SYSTEMS § 247. HALO "HOMOLOGS" AND ANALOGS § 248. CHALKOGENS (OXY VERSUS SULFUR)

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PROVING A DIFFERENCE IN PROPERTIES ...•••..........•............ 161 § 250. INTRODUCTION § 251. THE PRIMA FACIE CASE § 252. AFFIDAVIT SHOWING OVER THE CLOSEST SINGLE COMPOUND § 253. AFFIDAVITS AT THE VERY LATEST STAGE ARE BEST § 254. SHOWINGS BEYOND SUPERIORITY IN PROPERTIES § 255. COMPARATIVE SHOWINGS VIA CONTINUATION-IN-PART § 256. COMPARATIVE SHOWINGS ON APPEAL § 257. POST-APPEAL SHOWINGS VIA SECTION 145 ACTION § 258. POST-DECISION SHOWINGS VIA CONTINUATION-IN-PART

METHOD OF USE CLAIM OBVIOUSNESS ISSUES ...........•............ 176 § 260. INTRODUCTION § 261. METHOD OF USE § 262. KUEHL, CONVENTIONAL METHOD, USE OF NEW PRODUCT § 263. MANCY, KUEHL APPLIED TO BIOTECHNOLOGY METHODS § 264. KIFER, THE BOARD'S DENIAL OF KUEHL § 265. ORSER, KIFER APPLIED TO BIOTECHNOLOGY § 266. PLEUDDEMANN, KUEHL REVISITED § 267. DILLON, DICTUM LIMITING DURDEN

METHOD OF MAKING OBVIOUSNESS ISSUES .......................... 190 § 270. INTRODUCTION § 271. L./JJiSEN, ORIGIN OF THE DURDEN LINE OF CASES § 271. THE SMITH DISSENTS IN HOEKSEMA, SURREY AND ROSS § 273. DURDEN IN EUROPE AND JAPAN § 274. COMMON POLICY FOR BOTH TYPES OF METHOD INVENTIONS

PRODUCT-BY-PROCESS CLAIMS .................................... 204 § 280. PRODUCT-BY-PROCESS CLAIMS § 281. ADDED PROTECTION FROM PRODUCT-BY-PROCESS CLAIMS § 282. PRODUCT-BY-PROCESS CLAIM ENFORCEMENT LIMITATIONS § 283. PRODUCT-BY-PROCESS CLAIM SCOPE OF PROTECTION

PURITY AND ACTIVITY LEVEL LIMITATIONS ••.•....•.•................. 208 § 284. PRODUCT DEFINED IN TERMS OF PURITY OR ACTIVITY § 285. PURITY LEVEL TO DISTINGUISH FROM THE PRIOR ART § 286. PURITY AS BASIS FOR A DISTINCTION IN BIOTECHNOLOGY § 287. FORMULATIONS AND DOSAGE-LIMITED CLAIMS

JEPSON AND OTHER PRIOR ART "ADMISSIONS" ........................ 210 § 290. INTRODUCTION § 291. ADMISSIONS OF THE APPLICANT AS "PRIOR ART' § 292. SPECIFICATION CRAFTSMANSHIP TO AVOID ADMISSIONS § 293. JEPSON CLAIMS (PREAMBLE PRIOR ART ADMISSION) § 294. ADMISSIONS BASED UPON STATEMENTS OF "EQUIVALENCY"

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§ 295. MARKUSH CLAIMS

CLAIMS AND THEIR INTERPRETATION ............................... 216 § 300. INTRODUCTION § 301. PRINCIPLES STEMMING FROM MECHANICAL ARTS § 302. PREMIUM ON LITERAL PROTECTION § 303. THE STATUTORY SCHEME: 35 USC § 112 § 304. DEFINING THE PERIPHERY (NOT THE INVENTION) § 305. THE AMERICAN MULTIPLE CLAIM SYSTEM § 306. DEFINING CLAIM TERMINOLOGY IN THE SPECIFICATION § 307. THE PROSECUTION HISTORY TO INTERPRET LITERAL SCOPE § 308. CAREFUL CRAFTING OF THE GENERIC SCOPE § 309. "GIST", "HEART" AND "OBJECTS" OF THE INVENTION

CLAIM STRUCTURE ............................................. 223 § 310. INTRODUCTION § 311. OPENING, PREAMBLE AND ELEMENTS § 312. THE CLAIM IS AN OBJECT OF A SINGLE SENTENCE § 313. PREAMBLES (INCLUDING FUNCTIONAL LIMITATIONS) § 314. THE TRANSITION § 315. ELEMENTS, THE KEY TO THE § 316. 'WHEREBY" AND OTHER FUNCTIONAL CLAUSES § 317. APPARATUS LIMITATIONS IN A PROCESS CLAIM

DETERMINING THE LITERAL SCOPE OF THE CLAIM ..................... 236 § 330. INTRODUCTION § 331. "ORDINARY' •• MEANING' • ''', BUT § 332. PENMVALT "ALL ELEMENTS" RULE § 333. PATENTEE AS HIS OWN LEXICOGRAPHER § 334. THE SPECIFICATION AS A MANDATORY AID § 335. THE PROSECUTION HISTORY § 336. CONTEMPORANEOUS DEFINITION § 337. EXPERT TESTIMONY TO DETERMINE MEANING § 338. RELATIONSHIP OF THE SEVERAL CLAIMS § 339. CLAIM DIFFERENTIATION § 340. EXCLUSION OF UNSTATED LIMITATIONS § 341. EACH CLAIM IS SEPARATELY INTERPRETED § 342. NARROW DEPENDENT CLAIM FOR BROADER GENUS § 343. EXPERT TESTIMONY TO DETERMINE CLAIM MEANING § 344. IMPRECISE CLAIM LIMITATIONS § 345. GORE, IMPRECISE NUMERICAL RANGES § 346. ANDREW, "SUBSTANTIALLY EQUAL' •• " § 347. DUPONT, USE OF THE PROSECUTION HISTORY § 348. AMGEN, INVALIDITY WITH IMPRECISE TERMINOLGY

"MEANS" LIMITATIONS .................•..•.•.................... 233 § 320. INTRODUCTION § 321. "MEANS" LIMITATION IN THE CLAIM § 322. THE "SINGLE MEANS" CLAIM § 323. DIFFICULTIES FOR FOREIGN PROSECUTION

INFRINGING ACTS UNDER VARYING STATUTORY CATEGORIES ............. 253 § 350. INTRODUCTION § 351. DIRECT INFRINGEMENT UNDER § 271 (a)

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§ 352. ACTIVE INDUCEMENT UNDER § 271 (b) § 353. CONTRIBUTORY INFRINGEMENT UNDER § 271 (c) § 354. PROCESS PATENT INFRINGEMENT UNDER § 271(9) § 355. EXPERIMENTAL USE EXEMPTION § 356. DRUG REGULATORY TESTING EXEMPTION § 357. FIRST SALE EXHAUSTION § 358. PERMISSIBLE REPAIR (VERSUS RECONSTRUCTION) § 359. PARALLEL IMPORTS

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INFRINGEMENT DETERMINATION .....•............................. 295 § 360. INTRODUCTION § 361. ALL ELEMENTS MUST BE FOUND IN THE ACCUSED DEVICE § 362. AVOIDING INFRINGEMENT DESPITE LITERAL INFRINGEMENT § 363. INVALIDITY UNDER THE TELEGRAPH CASE § 364. PURIFIED PROTEIN PATENTS § 365. "REVERSE DOCTRINE OF EQUIVALENTS" § 366. "LIMITATIONS" IN THE SPECIFICATION § 367. ROLE OF THE PATENTEE'S PREFEREED EXAMPLES § 368. PATENTABILITY OF THE ACCUSED INFRINGEMENT ITSELF

THE DOCTRINE OF EQUIVALENTS .................................. 305 § 370. DOCTRINE OF EQUIVALENTS TO EXPAND THE SCOPE § 371. EQUITABLE ORIGINS OF THE DOCTRINE § 372. "COLORABLE" VARIATIONS § 373. SUBSTANTIALLY THE SAME FUNCTION, WAY AND RESULT § 374. PATENTABILITY DOES NOT AVOID INFRINGEMENT § 375. PIONEER PATENTS, BROADER RANGE OF EQUIVALENTS § 376. CLAIM CONSTRUCTION TO SAVE VALIDITY § 377. ALL ELEMENTS MUST BE PRESENT § 378. SAME FUNCTION, MANNER AND RESULT § 379. LATER· DISCOVERED EQUIVALENTS

FILE WRAPPER (PROSECUTION HISTORy) ESTOPPEL .................... 316 § 380. INTRODUCTION § 381. THE RATIONALE FOR PROSECUTION HISTORY ESTOPPEL § 382. USE OF PROSECUTION HISTORY ALSO FOR LITERAL SCOPE § 383. CREATION OF THE ESTOPPEL DURING PROSECUTION § 384. AN AMENDMENT MAY (OR MAY NOT) CREATE ESTOPPEL § 385. AMENDMENTS IMPACTING SEVERAL CLAIMS § 387. OVERARGUMENT OF PATENTABILITY § 388. PRIOR ART TO DETERMINE SCOPE OF ESTOPPELS § 389. FORMAL ARGUMENTS MAY NOT CREATE ESTOPPEL

THE REVERSE DOCTRINE OF EQUIVALENTS ........................... 324 § 390. NARROWING TO AVOID LITERAL INFRINGEMENT § 391. THE U.S. STEEL CASE § 392. TEST FOR REVERSE EQUIVALENTS DOCTRINE § 393. THE "SUBSTANTIALLY DIFFERENT WAY" TEST § 394. CLAIMED (NOT MERELY DISCLOSED) EMBODIMENTS § 395. UNOBVIOUSNESS DOES NOT TRIGGER NON INFRINGEMENT § 396. BURDEN OF PROOF ON THE INFRINGER § 397. "SCOPE OF ENABLEMENT" THEORY

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DISCLOSURE REQUIREMENTS ............•..•............•........ 332 § 401. THE SUBSTANTIVE ASPECTS OF "FORMAL" REJECTIONS § 402. THE EXAMINER'S MOTIVATION FOR THE REJECTION § 403. THE PROPER "BREADTH" FROM EXAMINER TO EXAMINER § 404. THE IMPORTANCE OF CASE LAW § 405. EARLY DETECTION TO AVOID FATAL FORMAL ERRORS § 406. CIP FILED EARLY (BEFORE A STATUTORY BAR) § 407. UrTON ACQUIESCENCE § 408. THE PAPERLESS ACCOUNTING CASE § 409. FOUCHE INCORPORATION BY REFERENCE

THE 'WRITTEN DESCRIPTION" REQUIREMENT •.••••••.................. 338 § 410. INTRODUCTION § 411. AMENDED DEFINITION OF THE INVENTION § 412. AMENDED TERMS AT THE POINT OF NOVELTY § 413. THE BATCHELDER GROUND FOR REJECTION § 414. SUBGENERIC RANGES NOT IN THE ORIGINAL CASE § 415. READING DAUGHTER CLAIM ON PARENT DISCLOSURE § 416. GOSTElI AND CHESTER CASES § 417. CHESTER V. MILLER (FOLLOWING GOSTElI) § 418. MIXED SIGNALS FROM RALSTON PURINA § 419. INHERENT BASIS FOR THE DISCLOSURE

ENABLEMENT, "HOW TO MAKE" ...•........•........•.......•...... 349 § 420. INTRODUCTION § 421. DISCLOSURE OF "HOW TO MAKE" THE CLAIMED PRODUCT § 422. KEYING ENABLEMENT TO THE CLAIMED INVENTION § 423. KNOWN (OR OBVIOUS) STARTING MATERIALS § 424. THE LACK OF WORKING EXAMPLES § 425. THE BUNDY CASE § 426. PTO GUIDELINES ON PROPHETIC EXAMPLES § 427. FISHER "SCOPE OF ENABLEMENT" THEORY § 428. HORMONE RESEARCH AND AMGEN § 429. PATENT EXAMINER BIOTECHNOLOGY STANDARDS

ENABLEMENT, "HOW TO USE" ..........•...•....................... 356 § 430. INTRODUCTION § 431. PTO DRUG APPLICATION GUIDELINES § 432. A SINGLE PRACTICAL USE IN A LABORATORY ANIMAL § 433. ISENSTED, PTO "IMPRIMATUR" § 434. KRIMMEL, REPUDIATION OF ISENSTEAD § 435. "INCREDIBLE" PHARMACEUTICAL UTILITIES § 436. UTILITY COMMENSURATE IN SCOPE WITH THE DISCLOSURE § 437. ABSENCE OF A GENERIC UTILITY DISCLOSURE § 438. ONE UTILITY CARRIES A CLAIM TO A COMPOUND § 439. SCOPE OF ENABLEMENT FOR CANCER CASES § 440. ENABLEMENT AS OF THE FILING DATE § 441. CONTINUATION·IN·PART TO OVERCOME UTILITY DEFECTS

THE "BEST MODE CONTEMPLATED· •• " ............................. 372 § 450. INTRODUCTION § 451. SUBJECTIVITY, READING THE INVENTOR'S MIND

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§ 452. KNOWN DETAILS AS PART OF THE BEST MODE REQUIREMENT § 453. BEST WAY FOR MAKING CLAIMED PRODUCT § 454. THE RELEVANCE OF 'WORKING EXAMPLES" § 455. CONCEALMENT OF THE BEST MODE § 456. EARLY FILING TO AVOID COMMERCIAL DISCLOSURES § 457. "BURYING" THE BEST MODE § 458. BEST MODE FOR PATENTING IN EUROPE AND JAPAN

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BIOTECHNOLOGY DEPOSITS ..........•.•••....................... 392 § 460. INTRODUCTION § 461. MPEP GUIDELINES § 462. 1990 BIOTECHNOLOGY DEPOSIT REGULATIONS § 463. REASONABLE NUMBER OF SPECIES FOR A GENUS § 464. POST-FILING DEPOSITS (LUNDAK) § 465. FOREIGN RIGHTS VERSUS PTO RULES § 466. DEPOSITS CREATED AFTER THE FILING DATE § 467. TERM OF DEPOSIT § 468. IDENTIFICATION OF SAMPLE REQUESTERS § 469. "BEST MODE * * *" TRAP FOR THE UNWARY

DUTY OF DISCLOSURE . . . . . . . . . . . • . • • . . . . . . . . . . . . . . . . . . . . . . . . . . . . 423 § 500. DUTY OF CANDOR IN PATENT PROSECUTION § 501. PTO STANDARD OF DISCLOSURE § 502. THE INFORMATION DISCLOSURE STATEMENT § 503. "IMPORTANT' INFORMATION: THE STANDARD OF § 504. FAILURE TO CITE PERTINENT PRIOR ART REFERENCES § 505. DOCTORED EXAMPLES DESTROYING OPERATIVE TEACHING § 506. COMPARATIVE SHOWINGS NOT GIVING THE FULL PICTURE § 507. KINGSDOWN, THE INTENTION ELEMENT § 508. THE RCA INTERPRETATION OF KINGSDOWN § 509. HEWLETT-PACKARD INTERPRETATION OF KINGSDOWN § 510. GREENWOOD INTERPRETATION OF KINGSDOWN § 511. KEYSTONE DRILLER POISONING RELATED PATENTS § 512. KEYSTONE DRILLER IN CONSOLIDATED ALUMINUM

DOUBLE PATENTING ............................................ 439 § 530. INTRODUCTION § 531. "SAME INVENTION" DOUBLE PATENTING § 532. "OBVIOUSNESS" DOUBLE PATENTING § 533. PHILLIPS PETROLEUM INTERPRETATION OF KAPLAN § 534. JUNIOR-FILED, EARLIER-GRANTED REFERENCE PATENT § 535. COMMON OWNERSHIP DOUBLE PATENTING § 536. TERMINAL DISCLAIMER TO OBVIATE "OBVIOUSNESS" BASIS § 537. THE USEFUL SPLITIING OF CLAIMS INTO TWO CASES § 538. TERMINAL DISCLAIMERS AFTER A FINAL REJECTION

RESTRICTION PRACTICE .................•....................... 445 § 540. INTRODUCTION § 541. RESTRICTION BETWEEN DIFFERENT INVENTIONS § 542. PATENTABLE DISTINCTNESS FOR A VALID RESTRICTION § 543. DEFERRAL OF DIVISIONAL FILINGS UNTIL ALLOWANCE § 544. ELECTIONS AWAY FROM COMPARATIVE SHOWINGS § 545. PATENTABLE DISTINCTNESS FOR A VALID RESTRICTION § 546. RESTRICTION BETWEEN (NOT WITHIN) CLAIMS

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ELECTION OF SPECIES .................••....................... 448 § 550. INTRODUCTION § 551. MINIMUM ELEMENTS OF A VALID ELECTION OF SPECIES § 552. AN ELECTION OF SPECIES IS ALWAYS PROVISIONAL § 553. THE PROVISIONAL TRAVERSE § 554. PATENTABLE DISTINCTNESS FROM ELECTED INVENTION

MAR KUSH-ELECTION INTERFACE ..........•.•...................... 450 § 560. INTRODUCTION § 561. MARKUSH CLAIM PROPRIETY UNDER § 112 § 562. "RESTRICTION" OF A MARKUSH CLAIM UNDER § 121 § 563. "REJECTION" OF A MARKUSH CLAIM UNDER § 121 § 564. HARNISCH "JUDICIAL" MARKUSH PRACTICE § 565. HOZUMIINTERPRETATION OF THE HARNISCH STANDARD § 566. THE APPLICANT'S PROBLEMS WITH MARKUSH § 567. PROBLEMS WITH MARKUSH. FOR THE EXAMINER § 568. PROBLEMS WITH MARKUSH. FOR THE PUBLIC § 569. MARKUSH ALLEGED ADMISSIONS OF UNPATENTABILITY

INTERNATIONAL UNITY STANDARDS ...•............................. 471 § 570. INTRODUCTION § 571. PATENT COOPERATION TREATY RULE 13.1 § 572. WIPO HARMONIZATION TREATY § 573. A TREATY-CONSISTENT MARKUSH SOLUTION § 574. PCT "UNITY" IS MORE LIBERAL THAN 35 USC §121 § 575. PCT RULE 13 IS ONLY INDIRECTLY APPLICABLE TO U.S.

INTERNATIONAL PRACTICE DIFFERENCES ............................ 475 § 580. INTRODUCTION § 581. LIMITED OR NON-EXISTENT GRACE PERIODS § 582. VARYING DEFINITIONS OF PRIOR ART § 583. ABSENCE OF "SECRET" PRIOR ART § 584. EMERGENCE OF A QUASI CONTINUATION-IN-PART PRACTICE § 585. DIFFERING INVENTORS FOR RELATED SUBJECT MATTER § 586. JAPANESE STANDARD FOR COMPLETION OF THE INVENTION § 587. CLAIM DRAFTING CONSIDERATIONS § 588. DIFFERING BIOTECHNOLOGY DEPOSIT STANDARDS

TABLE OF CASES ............................................... 483

INDEX ..............................•........................ 499

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