THE CHEMIST’SCOMPANION GUIDETO PATENT LAW

Chris P. MillerMark J. Evans

A JOHN WILEY & SONS, INC., PUBLICATION

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THE CHEMIST’SCOMPANION GUIDETO PATENT LAW

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THE CHEMIST’SCOMPANION GUIDETO PATENT LAW

Chris P. MillerMark J. Evans

A JOHN WILEY & SONS, INC., PUBLICATION

Copyright ©CC 2010 by John Wiley & Sons, Inc. All rights reserved.

Published by John Wiley & Sons, Inc., Hoboken, New Jersey.Published simultaneously in Canada.

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Library of Congress Cataloging-in-Publication Data

Miller, Chris P.The chemist’s companion guide to patent law / Chris P. Miller, Mark J. Evans.

p. cm.Includes bibliographical references and index.ISBN 978-0-471-78243-8 (cloth)1. Patent laws and legislation–United States. 2. Chemistry–United States–Patents.

3. Chemical industry–Law and legislation–United States. I. Evans, Mark J. II. Title.KF3133.C4.M55 2010346.7304′86–dc22

2010000195Printed in the United States of America

10 9 8 7 6 5 4 3 2 1

http://www.copyright.comhttp://www.wiley.com/go/permissionhttp://www.wiley.com

CONTENTS

Disclaimer ix

Preface xi

1. Patent Basics 1

1.1 Introduction 11.2 Patents as Property 11.3 Patent Rights Are Rights to Exclude 21.4 Patents Do Not Convey Freedom to Operate the Invention 41.5 Contrasting Freedom to Operate with Patentability 51.6 Assignment and Recording of Patents 151.7 Why Have Patents? 16

2. The Patent Process 19

2.1 An Overview of the Patent Process in the United States 192.2 Post Grant Procedures at the USPTO 46

2.2.a Patent Maintenance Fees 472.2.b Reissue Applications and Patents 492.2.c Ex Parte Procedures 542.2.d Inter Partes Procedures 58

2.3 Inequitable Conduct in Patent Prosecution 60

3. Prior Art and the Chemical Invention 80

3.1 What is Prior Art? 803.2 Prior Art That Can Be Antedated 83

3.2.a §102(a) 833.2.b §102 (e) 883.2.c §102 (f) 903.2.d §102(g) 90

3.3 Prior Art That Is an Absolute Bar 95

3.3.a §102 (b) 963.3.b §102(c) 993.3.c §102(d) 99

3.4 Section 102 References in Support of Obviousness Rejections 100

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3.5 Double Patenting 1023.6 Obviousness-Type Double Patenting 1043.7 Prior Art Hypothetical Example 1 1053.8 Hypothetical Example 2 108

4. Inventorship 117

4.1 Inventorship and Ownership of U.S. Patents 1174.2 Patent Validity and Correct Listing of Inventorship 1214.3 Determining Inventorship 126

5. Patent Claims 134

5.1 Introduction to Claim Language and Structure 1345.2 Independent and Dependent Claim Types 1345.3 Claim Structure 1385.4 Transition Phrases 1425.5 Markush Claiming in Chemical Patents 1465.6 Claim Construction 148

6. Basic Requirements of Patentability: Utility 156

6.1 The Six Requirements of Patentability 1566.2 Statutory Subject Matter of the Utility Requirement 1586.3 What Makes a Chemical Invention Useful? 161

7. Basic Requirements of Patentability: Novelty 168

7.1 Requirements of the Prior Art to Defeat Novelty 1697.2 Anticipation in Chemical Patents 1707.3 Anticipation of a Claimed Genus by a Species Falling Within

that Genus 1807.4 Anticipation of a Species Claim by a Prior Art Genus 1877.5 Anticipation of a Range by a Prior Art Species Falling Within

that Range 1927.6 Inherent Anticipation 193

8. Basic Requirements of Patentability: Nonobviousness 198

8.1 The Basis for the Nonobviousness Requirement 1988.2 Understanding §103(a) 1998.3 Graham Factors Analysis of Obviousness 2038.4 Focusing the Obviousness Inquiry: Prima Facie Obviousness

and the Chemical Invention 2078.5 Application of the TSM Test to the Chemical Arts 2108.6 Prior Art as a Whole Must Be Considered for TSM Tests 2178.7 Obviousness and Unpredictability in the Art 219

CONTENTS vii

8.8 Unexpected Results as Secondary Indices of Nonobviousness 225

8.8.a Unexpected Results Must Be Taught by, or Flow fromthe Patent Application 227

8.8.b Unexpected or Superior Results Can Be DemonstratedThrough a Single Property 228

8.8.c Unexpected Results: Different in Degree or Differentin Kind? 229

8.8.d The Claimed Invention Must Be Tested Against theClosest Prior Art 233

8.9 Prima Facie Obviousness Based Primarily on Similarity ofChemical Structure 234

8.9.a Isomers and Homologues 2358.9.b Enantiomers 238

8.10 Obviousness of a Species or Genus in Light of a Prior Art Genus 2508.11 Obviousness of Ranges 2598.12 Changing the Sequence of Ingredient Addition 2688.13 Obviousness of Combining Equivalents Together for Same

Known Purpose 2708.14 Substituting Equivalents Known for the Same Purpose 2728.15 Purified Forms of Compounds or Materials 274

9. Basic Requirements of Patentability: Written Description,Enablement, and Best Mode 281

9.1 The Written Description Requirement 2829.2 Enablement 3039.3 Best Mode 312

Afterword and Sources 318

Acknowledgments 320

Cases Cited 321

Index 327

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DISCLAIMER

A man who is his own lawyer has a fool for a client (although he won’t have to payany fees).

—Source unknown

The legal information contained in this book is just that, legal information. Noneof the information contained in this book is intended to constitute, nor should itbe interpreted to constitute, legal advice. While we have attempted to ensure theaccuracy of the material in this text, please appreciate that mistakes can happenand interpretations of law as expressed herein are merely interpretations and notnecessarily correct. Readers with specific legal questions are advised to contact andconsult with competent legal counsel. The views expressed herein are the authors’views alone and do not reflect the views of any organization, business, or associationthat the authors might have been, currently are, or will be affiliated with in any way.Furthermore, one needs to appreciate that any discussion as it relates to the law oftencannot be extrapolated to situations not yet considered. A decision in a particularcase depends on the particular facts of that case, and since no two cases will haveexactly the same facts, the law as applied may be different despite other apparentsimilarities. This text reflects no more than the authors’ desire to provide a narrativefor the interested reader in the topic at hand. The discussion herein should not beconstrued as taking a particular position on any legal matter, nor is it to be construedas advocating any single position. Any appearance to the contrary is not intentional.

The hypothetical examples are included for illustrative purposes only—they shouldbe accorded no weight as prior art against inventors’ future activities. Furthermore,under no circumstances is it the authors’ intent to imply that any of the compoundsor compositions presented herein can be safely produced by any of the processesdescribed herein nor used according to any of the methods described in this text.

In several instances, the authors have included fictional characters to enrich thelearning experience. Any resemblance to any person, past, present, or future is entirelycoincidental and unintended.

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PREFACE

Law never is but is always about to be.—Benjamin Cardozo

Oh boy, here we go again, yet another book on patent law, just what I’ve been waitingfor. Frankly, that is the usual reaction that many have when seeing an article or texton patent law—it’s hard to imagine too many subjects that are drier. For many of you,reading or studying patents is far down the list of your preferred tasks for a given day,perhaps somewhere between washing glassware and emptying the chemical wastecans. A natural aversion to chemical patent law is not surprising because most of yourexposure to patent law has probably come from reading (or helping to write) patentsand/or patent applications. In the course of reading the patent literature, you surelyhave been assaulted with a sometimes bewildering array of gobbledygook from whichyou are supposed to sift out something meaningful. Somewhat counterintuitively, thedifference between the level of description, detail, and clarity in a typical scientificpaper often exceeds what you might find in the related patent literature—given achoice, very few chemists will choose the patent literature as their primary source forbackground scientific information in a topic subject area.

Some of this difference can be attributed to careless application drafting or appli-cation drafting habits unmoored from legal reality—sometimes an overly burdenedpatent attorney might rely on boilerplate recitation to the exclusion of real descrip-tion, and the end result is not always helpful. In that regard, patents resemble manylegal documents, which are why they are usually about as much fun to read as thewarranty for your new refrigerator. However, there also are more valid reasons forthe sometimes peculiar language and style encountered in the patent literature. Wehope these reasons will become clearer as we move along.

Before proceeding farther into this book, let’s all take a collective deep breath andrelax because this book is not boilerplate and, we hope, will be more lucid if not moreinteresting than the typical patent or patent application. Rather than going throughan array of patents and explaining their parts in tedious detail so that reading thepatents would have been fun in comparison, we are approaching the subject matter ina different way. The approach relied on herein is more similar to the approach usedfor learning in law school and includes a combination of explanation surrounding agiven topic coupled with discussions centered on actual federal court opinions.

Briefly, the hierarchy of patent law in the United States begins first with the U.S.Constitution, which provides the discretionary basis for federal regulation of patent

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laws.1 Acting on its discretionary authority, Congress has enacted federal patent lawsthat are outlined in the U.S. Code Title 35 (the Code). The Code establishes the sub-stantive framework that federal judges must interpret and apply.2 In contrast, patentrules are administrative in nature and are outlined in the U.S. Title 37—Code of Fed-eral Regulations (the Regs). The Regs outline the administrative rules for conductingbusiness at the U.S. Patent Office (USPTO).3 Beyond the USPTO rules, there is theManual of Patent Examining Procedure (MPEP). The MPEP provides detailed in-struction to the USPTO examiners with the USPTO’s interpretation of myriad issuesrelated to the procurement of patents (patent prosecution) in the United States. Notonly is the MPEP an invaluable legal reference for USPTO patent examiners but it isalso an invaluable resource for patent practitioners and chemists who have an interest.The MPEP contains the Code, the Regs, and the very extensive explanation of theUSPTO’s interpretation of what the law is in regard to whether your patent shouldissue or not—we will refer to it often.4

The Code and Regs provide only the minimum level of detail, and by themselves,do not provide for their own interpretation. That is for the job of the U.S. federalcourt system that oversees cases and controversies related to patents, copyrights, andtrademarks.5 Through their many opinions and findings, the U.S. federal courts makeand explain the law, filling in the myriad gaps left by the sparse language of thestatutes by applying that law to the facts of the particular cases and controversies theyadjudicate. Through a system of precedent, the federal courts both rely and build onthe rules and reasoning from previous decisions. The written decisions (cases) issued

1At least in theory, those powers not explicitly granted to the federal government by the U.S. Constitutionare reserved for the states. However, in contrast to much federal law, which often has a tortured ortenuous link to any explicit grant in the U.S. Constitution, Article 1 §8 of the Constitution grants explicitauthority to the federal legislature to make laws governing the protection of inventions: “Congress shallhave power . . . to promote the progress of science and useful arts, by securing for limited time to authorsand inventors the exclusive right to their respective writings and discoveries.”2So when you see something that has 35 U.S.C. followed by a number (e.g., 35 U.S.C. 102), you willknow this is a federal statute.3In the case of any apparent conflict in interpretation, federal laws take priority over federal rules in termsof judicial authority. Patent rules can be typically recognized by their numbers. They begin at §1.1 andcurrently proceed up to §1.997. The patent rules outline the specific details and requirements that theUSPTO has for the many different functions that it carries out with applicants/patentees. For example, rule§1.121 covers the USPTO’s policy regarding the publication of patent applications.4If you find yourself in the position of needing to know any specific detail about patent law prosecutionthen the MPEP is indispensable. The MPEP online can be found at the following site in the USPTO Internetdomain: www.uspto.gov/web/offices/pac/mpep/mpep.htm. The MPEP is also available in paperback copyfrom the legal publishers West and Lexus-Nexus.5To appreciate why federal court opinions are so important to understanding patent law, it is first necessaryto appreciate that issues related to patents are in the subject matter jurisdiction of the federal courts. TheU.S. Constitution specifically grants Congress the discretionary power to regulate patents, and Congressasserted that jurisdiction pursuant to 28 U.S.C. §1338 (a), which states “The (federal) district courts shallhave original jurisdiction of any civil action arising under any Act of Congress relating to patents, plantvariety protection, copyrights and trademarks. Such jurisdiction shall be exclusive of the Courts of thestates in patent, plant variety protection and copyright cases.” Thus patents, together with military law,copyrights, immigration, and bankruptcy, make up federal question jurisdiction as explicitly described inthe Constitution and exercised by Congress.

PREFACE xiii

from the courts reveal their interpretations of the law. From these cases we will learnthe nuts and bolts of patent law and by thoroughly familiarizing ourselves with theirfacts and legal reasoning, we can become better at divining how situations relevantto our own might be decided, should they ever end up in litigation.

From a procedural standpoint, unfavorable patent decisions by USPTO examiners(e.g., rejected patent claims/applications) can be appealed to the U.S. Board of PatentAppeals and Interferences (the Board). If the outcome at the Board is unfavorableto the applicant then the applicant may appeal the decision to the Court of Appealsof the Federal Circuit (CAFC). Unfavorable decisions from the CAFC may befurther appealed by petition for a writ of certiorari to the U.S. Supreme Court.6

While patent appeals from the Board to the CACF may be made as a matter of right,appeals from the CAFC to the Supreme Court are not. Due to the Supreme Court’sbroad jurisdiction and very limited capacity to hear cases, only a very small percentof cases that are appealed (approximately 1%) are heard (so good luck!).7 Patentlitigation on the other hand involves the enforcement of patents that have already

6Most case opinions cited in this text will be from the CAFC and in some case the U.S. Supreme Court. AllSupreme Court, CAFC, and most CCPA (CAFC’s predecessor) case opinions (back to 1950) cited in thistext can be found at www.altlaw.org. District court cases, unfortunately, are harder to come by without a payservice; however, cases back to 2004 can be found for free at http://cases.justia.com/federal/district-courts/.Opinions of the Board from 1997 can be found at http://des.uspto.gov/Foia/BPAIReadingRoom.jsp. Casecitations as presented herein will give the case heading (e.g., Bayer Corp. v. Schein Pharm. Co.), the courtthe opinion came from, and the year of the opinion. There usually will also be a cite listing to the federalreporter (a type of journal for federal cases) from which the opinion can also be accessed, though thisrequires a fee. Unless you have access to the federal court reporter referenced, you should not use thecourt reporter citation when you search the case. So if you find the following cite: Bayer Corp. v. ScheinPharm. Co. 301 F.3d 1306 (CAFC 2002) and wish to find the free copy of the decision, you will not wantto include the citation to the court reporter and page (301 F.3d 1306). Searching the court opinions atwww.altlaw.org is generally best accomplished by searching the case heading only (Bayer Corp v. ScheinPharm) and by not including the cite to the federal reporter or any of the other information—if you includemore information than just the case title, then you are likely to pull up the many cases that are citing thatcase but not the case itself. If a spot cite is made to a specific page of the reporter, then usually there will betwo page numbers separated by commas after the reporter edition. The first number is the page on whichthe case starts in the reporter and the second number (or page range) is where the quote or specificallyreferenced material can be found. Quoted material in the text or notes may or may not refer to the page inthe reporter, and the case opinion may or may not refer to a federal reporter citation, depending on howthe authors accessed the information. If a page number is cited, that page number refers only to where thereferenced material can be found in the court reporter and not to the actual case opinion that you will findat the free web locations listed here.

While little if any of what you work on in the patent arena is likely to be involved in litigation beforea court, the assumption should still be made that it will because even short of litigation, the perceivedvalidity of a patent is often the key determinant of whether a patent will actually be challenged in court. Asa corollary, the value of a patent is often a function of its perceived validity, and as a result, many businessdeals involving patents are structured accordingly. Competent patent validity opinions prepared by patentcounsel are based on legal reasoning primarily derived from federal patent case law precedence.7A petition for certiorari means that the petitioner is asking the court to use its discretionary power toreview the case. The Supreme Court hears most cases on petition known as a writ of certiorari. Of thethousands of writs received in a given year, fewer than 100 are granted. To accept a case on a writ ofcertiorari, four out of the nine justices must agree (the so-called rule of four) that the petition should begranted.