Detailed Table of Contents

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1 Detailed Table of Contents Contributors... v v Foreword... vii vii Preface... ix ix Author Biographies... xi xi Summary Table of Contents... xix xvii Chapter 1. The State of the Law of Claim Construction and Infringement I. Introduction... 2 II. Applicants Bear the Burden to Draft Carefully A. Obvious, Harmless Errors Are Correctible... 3 B. Serious Errors Are Not Correctible C. The Indefiniteness Threshold Is High III. Claim Construction A. Standard of Review B. Phillips v. AWH... 9 C. General Claim Construction Principles Applicant as Lexicographer Preamble Terms and Transitional Phrases Context of Other Claims (Claim Differentiation) Disclaimer of Claim Scope Means-Plus-Function Limitations Other Claim Construction Principles D. PTO Applies Broadest Reasonable Interpretation xix

2 xx Drafting Patents for Litigation and Licensing 2012 IV. Infringement Direct and Indirect A. Direct Infringement: Literal Infringement All Limitations Must Be Satisfied Extraterritorial Acts Can Infringe The Evidentiary Burden at Trial B. Direct Infringement: Doctrine of Equivalents Determining Equivalence: Insubstantial Difference and Triple Identity Bars to the Doctrine of Equivalents a. Prosecution History Estoppel i. Rebutting the Festo Presumption b. The All-Elements Rule ( Vitiation and Specific Exclusion ) C. Indirect Infringement Active Inducement Under Section 271(b) Contributory Infringement Under Section 271(c) Extraterritorial Indirect Infringement V. Conclusion Footnote Updates Chapter 2. Pitfalls in Patent Drafting I. Introduction II. Pitfalls in Drafting the Specification A. Specifications Having Narrow Descriptions Titles Having Unnecessary Verbiage Narrow Field of the Invention/Background of the Invention/Prior Art Narrow Abstracts Narrow Summary of the Invention Specific Problems in the Specification and Drawings a. Objects of the Invention and Similar Characterizations b. Criticizing Prior Art in the Specification c. Use of Language Implying Criticality d. Unintentional Definitions of Claim Terms e. Disclosing Only a Single Embodiment of the Invention f. Referring to The Invention g. The Dedicated to the Public Doctrine h. Referring to Prophetic Examples in the Patent... 76

3 Detailed Table of Contents xxi B. Failure to Provide Sufficient Written Description/ Enablement Support Claim Overspecificity Claim Overbreadth C. Potential Pitfalls With Provisional Patent Applications Failure to File Foreign Applications Within One Year of Provisional Filing Filing Provisionals for the Wrong Reasons Dangers of As-Is Filings Failure to Establish Ownership for Provisionals Failure to Claim Subject Matter Supported Entirely by the Provisional Filing Failure to Carry Over All Subject Matter From Provisional Into Nonprovisional III. Pitfalls in Claim Drafting A. Uncertainty Regarding Whether a Preamble Is Limiting B. Claims That Are Broader Than the Disclosure or Not Commensurate in Scope With the Disclosure C. Use of Claim Terminology That Can Change Over Time D. Multiparty Infringers and Divided Infringement Claims E. Pitfalls of Means-Plus-Function Claims Unintended Means-Plus-Function Clauses Attempted Means-Plus-Function Clauses Not Interpreted as Such Single-Means Claims Failure to Clearly Link Structure in the Specification to the Recited Function Insufficiently Described Corresponding Structure F. Functional Claiming G. Territorial Scope Problems H. Indeterminate Scope of Whereby Clauses I. Definiteness Problems Use of Relative Terminology Failure to Provide Antecedent Basis for Claim Elements Failure to Define Coined Terminology [New Topic] J. Failure of a Dependent Claim to Further Limit a Parent Claim

4 xxii Drafting Patents for Litigation and Licensing 2012 K. Use of Jepson-Type Claims L. Reciting Operating Conditions or Usage in Apparatus Claims M. Reciting Human Activities in Claims IV. Pitfalls in Patent Prosecution A. Prosecution Disclaimer B. Amendment-Based Estoppel C. Argument-Based Estoppel D. How to Festo-Proof a Patent Application E. Clearly Link Arguments to Specific Claims V. Other Problems Affecting Patent Rights or Scope A. Failure to Investigate Potential Bars to Patentability B. Failure to Correctly Determine Inventorship or to Establish Ownership C. Failure to Claim the Commercial Embodiment D. Failure to Mark Patent Numbers on Covered Devices E. Failure to Proofread the Issued Patent VI. Conclusion Footnote Updates Chapter 3. Drafting the Winning Patent I. Introduction II. Pre-Drafting Activities A. Meeting With the Inventors Avoid Legal Jargon Prepare for the Meeting Take Good Notes Be Aware of Time-Sensitive Matters, Including Statutory Bars and Later- Developed Best Modes Draft a Sample Claim During the Meeting Determine Inventorship Ask About Reduction to Practice B. Searching for Prior Art III. Drafting the Specification and Drawings A. Clarity and Breadth in the Specification Keep It Simple Don t Leave the Reader Hanging Follow a Logical Progression With Broadly Worded Language Clarity in Drawings

5 Detailed Table of Contents xxiii 5. Include Multiple Embodiments and Examples Use Self-Serving Statements and Boilerplate Include Broad Definitions of Claim Terms Use Terminology Consistently in the Specification and Claims Favor Over-Inclusion Rather Than Under- Inclusion Use Incorporation by Reference Carefully IV. Drafting the Claims A. When to Draft the Claims B. Include as Many Claim Types as Possible C. Include Primary Independent Claims to Smallest Independent Unit of Invention D. Include Claims of Broad, Intermediate, and Narrow Scope E. Recite Minimum Number of Elements to Avoid Known Prior Art F. Trim Unnecessary Words From Claims G. Use a Variety of Claim Terminology Consistent With the Specification H. Rely on Claim Differentiation to Maximize Claim Scope I. Carefully Select Preamble and Transition Phrases J. Targeting Infringers in Advance: Who Will Infringe the Claim? K. Selecting Dependent Claim Features L. How Many Claims Are Appropriate? M. Try to Design Around Your Own Claims N. Include a Picture Claim O. Using Terms of Approximation P. Carefully Recite Linkages Among Elements Q. Avoiding Indemnity Agreements Among Vendors R. Maximizing Damages and Royalties Through Claim Drafting V. Checklists for Drafting and Prosecution A. Quality Control and Second-Attorney Review B. Pre-Filing Checklist C. Checklist for Specification and Claims D. Checklist for Official Filing Receipt and Recorded Assignment E. Checklist for First Office Action

6 xxiv Drafting Patents for Litigation and Licensing 2012 F. Checklist for Patent Prosecution G. Checklist for Notice of Allowance H. Checklist for Granted Patent VI. Conclusion Footnote Updates Chapter 4. Continued Prosecution of the Patent I. The Family of Continuation Applications A. Continuations B. Continuations-in-Part (CIPs) C. Divisionals D. Prosecution Laches E. Certificate of Correction F. Continuing Prosecution Strategy II. Reissues A. The Patent for the Invention B. Through Error Without Deceptive Intent, Deemed Wholly or Partly Inoperative or Invalid C. Broadening Claims D. Nonbroadening Claims E. Recapture Rule Clement Analysis: Step Clement Analysis: Step Clement Analysis: Step Applying the Recapture Rule F. Intervening Rights G. Reissue Strategy III. Reexaminations A. Ex Parte Reexamination B. Inter Partes Reexamination Similarities and Differences With Respect to Ex Parte Proceedings Examination and Amendments Third-Party Estoppel and Litigation Merging Reexaminations Appeal C. Intervening Rights D. Reexamination Strategy U.S. District Court Patent Litigation Ex Parte Reexamination Inter Partes Reexamination Effective Reexamination Strategy An Example [New Topic]... 94

7 Detailed Table of Contents xxv IV. Post-Issuance Trials Under the Leahy-Smith America Invents Act [New Topic] A. Trial Procedures Before the Patent Trial and Appeals Board Scheduling Considerations Motions Practice Discovery Treatment of Confidential Information Use of the Federal Rules of Evidence Oral Argument Final Decision Settlement Regulation of Conduct of Counsel and Parties and Sanctions B. Inter Partes Review Preliminary Proceedings Trial Proceedings Appeal Impact on Litigation Strategies C. Post-Grant Review Preliminary Proceedings Trial Proceedings Appeal Impact on Litigation Strategies D. Transitional Program for Covered Business Method Patents The Legislative Debate Over the Transitional Program for Covered Business Method Patents Patents Subject to the Transitional Program for Covered Business Method Patents Key Differences Between Covered Business Method Patent Review and Post-Grant Review V. al Examination [New Topic] A. Scope and Procedures for al Examination B. Modified Ex Parte Reexamination Procedures Following al Examination C. PTO Discovery of Fraud D. al Examination s Impact on Litigation and Enforcement Strategies VI. Conclusion Appendix Footnote Updates

8 xxvi Drafting Patents for Litigation and Licensing 2012 Chapter 5. Mechanical Patents I. Introduction II. Validity of Mechanical Patents A. Written Description Issues The Traditional Rule: Mechanical Technologies Are Predictable Predictability in the Mechanical Arts After Gentry Gallery Don t Rely on Predictability for Mechanical Technologies B. Enablement Issues C. Definiteness Issues D. Obviousness Issues [New Topic] III. Claim Scope and Interpretation of Mechanical Patents A. Ordinary Meaning B. Avoiding Narrow Claim Scope The Critical Importance of the Written Description Maximizing Claim Scope in Mechanical Patents a. Disclose and Claim Multiple Embodiments b. Use Equivocal Language in the Specification c. Pursue Claims of Differing Scope and Type d. Avoid Describing Any Particular Feature, Aspect, or Embodiment as The Invention in the Specification e. Avoid Emphasizing Any Particular Object, Advantage, or Feature of the Invention in the Specification f. Avoid Describing the Invention Narrowly in Any Summary of the Invention g. Avoid Undue Emphasis Distinguishing Over the Prior Art h. Drawing Features Should Be Explained C. Means-Plus-Function Limitations in Mechanical Patents Careful Use of Section in Mechanical Cases Avoid Recitation of Structure Disclose Multiple Embodiments of Corresponding Structure

9 Detailed Table of Contents xxvii 4. Always Clearly Link Corresponding Structure to the Claimed Functions Avoid Unintentional Invocation of Section The Mysterious and Elusive Step-Plus- Function Claim IV. Other Enforcement Issues A. Some Sage Advice From the Federal Circuit Regarding Claim Drafting B. In Mechanical Cases, It May Be Difficult to Rebut the Festo Presumption V. Conclusion Footnote Updates Chapter 6. Electrical Patents I. Introduction II. Drafting Electrical Patent Specifications A. Statutory Considerations Utility Enablement and Written Description a. Predictability b. Problems With Claims Broader Than the Specification B. Limiting Statements in the Specification C. Characterizing The Invention D. Ensure Sufficient Support for Electrical Structures III. Claim Drafting Strategies A. Systems Including Paired Operations B. Components of a System C. Multiple Party Issues D. Method Steps Performed Outside of the United States E. Make Sure Claims Accurately Describe the Invention F. Transitional Phrases G. Problems With Means-Plus-Function Clauses H. Time-Dependent Terminology I. Use the Term Or Carefully J. Use Absolute Terms Carefully K. Definiteness Problems L. Claims to Semiconductor Devices M. Draft Claims of Different Scope [New Topic] IV. Conclusion

10 xxviii Drafting Patents for Litigation and Licensing 2012 Chapter 7. Software, E-Commerce, Internet, and Business Method Patents I. Introduction II. Validity of Software-Related Patents A. Written Description Issues B. Enablement Issues C. Best Mode Issues D. Definiteness Issues E. Statutory Subject Matter Issues Supreme Court Precedent a. Benson: Unpatentable Algorithm b. Flook: Another Unpatentable Algorithm c. Chakrabarty: Patentable Micro-Organism d. Diehr: Finally, a Patentable Algorithm e. Bilski: Unpatentable Abstract Idea [New Topic] Current Tests to Determine Statutory Subject Matter a. The Useful, Concrete, and Tangible Result Test [Moved] i. In re Alappat ii. State Street Bank iii. AT&T iv. Laboratory Corporation of America v. USPTO Guidelines vi. Summary b. The Transformation Test i. Supreme Court Precedent ii. Arrhythmia iii. USPTO Guidelines iv. Summary c. The Abstract Idea Test i. Supreme Court Precedent ii. Alappat, State Street Bank, and AT&T iii. In re Warmerdam iv. Comiskey [Moved] v. Research Corp. [New Topic] vi. USPTO Guidelines [Renumbered] vii. Summary [Renumbered] d. The Machine-or-Transformation Test [New Topic] i. In re Bilski [New Topic] ii. Comiskey I and Comiskey II [New Topic]

11 Detailed Table of Contents xxix iii. Ferguson [New Topic] iv. SiRF Technology [New Topic] v. USPTO Guidelines [New Topic] vi. Summary [New Topic] e. The Practical Application Test [New Topic] Previous Tests to Determine Statutory Subject Matter a. The Freeman-Walter-Abele Test b. The Business Method Test c. The Technological Arts Test d. The Useful, Concrete, and Tangible Result Test [New Topic] e. The Physical Steps Test [New Topic] III. Claim Scope and Interpretation of Software- Related Patents A. Claims for Software-Related Inventions Process Claims a. Process Claims Interacting With the Physical World b. Process Claims With No Interaction With the Physical World Apparatus Claims System Claims Claims With Means- or Step-Plus-Function Recitations Data Structure Claims Computer-Readable Medium Claims Signal Claims Software Module Claims [New Topic] Paradigm Claims [New Topic] B. Business Method Inventions Software-Related Business Method Inventions Non-Software-Related Business Method Inventions Post-Grant Review of Business Method Patents [New Topic] Summary [Renumbered] C. Claiming Strategies Claiming a Network or Internet Invention Claiming a Network Router Invention Claiming an E-Commerce Website Invention Claiming a Simulation Software Invention

12 xxx Drafting Patents for Litigation and Licensing 2012 IV. Conclusion Footnote Updates Chapter 8. Chemical and Pharmaceutical Patents I. Introduction II. Validity of Chemical and Pharmaceutical Patents A. Written Description Issues B. Enablement Issues C. Best Mode Issues D. Utility Issues E. Anticipation Issues in Chemical Applications: Inherency Inherent Anticipation Is Not Avoided by Discovery of a New Benefit or Property of an Old Material or Method Metabolite Claims Can Be Anticipated If the Metabolite Was Formed In Vivo After Administration of the Prior Art Drug Creative Claim Drafting Can Often Overcome Inherent Anticipation Problems A Sufficiently Small Prior Art Genus Can Anticipate a Later-Claimed Species F. Obviousness Issues in Chemical and Pharmaceutical Patents Pre-KSR Standards for Chemical Obviousness Post-KSR Chemical Obviousness G. Double Patenting Issues in Chemical Cases III. Claim Scope and Interpretation of Chemical and Pharmaceutical Patents A. Claim Scope Issues in Chemical and Pharmaceutical Patents Product-by-Process Claims a. Ambiguity as to Scope b. Clarity in Claim Scope Markush Groups a. Markush Group Members Must Share Some Relationship to Be Grouped Together Properly b. Careful Wording of a Markush Claim Is Necessary c. Provide Supporting Disclosure and Working Examples

13 Detailed Table of Contents xxxi 3. Transitional Phrases in Chemical Claims B. Means-Plus-Function Limitations C. Claim Drafting Strategies A Careful Review of the Chemical Invention Can Ensure That Claims to All Aspects of the Invention Are Included a. Consider the Existence of Metabolic Forms When Claiming a Compound b. In Pharmaceutical Patents, Consider Label Claims That Protect Specific Methods or Uses in the FDA-Approved Prescribing Information c. Use Care in Claiming a Polymorphic Form in Terms of Its Analytical Properties d. Consider Whether Salt Forms of a Compound Are Intended to Be Encompassed Within the Claim to the Free Acid or Base Pharmaceutical Claims to Methods of Treatment Pharmaceutical Claims to Homologs, Racemates, Salt Forms, and Metabolites D. Claim Interpretation Implicit and Explicit Definitions of Claim Terminology The Effect of Examples and Preferred Embodiments on Claim Construction Interrelationship of Claims Prosecution History: Disclaimers and Estoppel Use of Extrinsic Evidence in Interpreting Chemical Claims IV. Conclusion Footnote Updates Chapter 9. Biotechnology Patents I. Introduction II. Validity Issues Related to Biotechnology Patents A. Considerations Under 35 U.S.C. Section Patentable Subject Matter Utility B. Considerations Under 35 U.S.C. Section Enablement as of the Date of Filing and After-Arising Technology

14 xxxii Drafting Patents for Litigation and Licensing Written Description and Biological Organisms Deposited With the ATCC Written Description and DNA-Based Inventions [New Topic] C. Post Grant Review Under the AIA [New Topic] III. Claim Scope and Interpretation of Biotechnology Patents A. Claim Scope Is Fixed as of the Filing Date B. Process Limitations and Product Claims C. Interpreting Claims in Light of the Specification Multiple Interpretations of a Claim Versus a Single, Unambiguous Meaning Expansive Interpretation of a Claim Term May Result From the Use of Varied Terms, or the Use of the Term in Different Contexts, in the Specification Avoiding Restriction of the Invention to the Disclosed Preferred Embodiment Relative Terms: Substantially, About, and At Least Calculations D. The Role of the Preamble in Biotechnology Claims Griffin v. Bertina Manning v. Paradis Rapoport v. Dement and Jansen v. Rexall Sundown, Inc In re Cruciferous Sprout Litigation Boehringer Ingelheim Vetmedica, Inc. v. Schering-Plough Corp E. Nontraditional Claim Language F. Infringement of Process Claims [New Topic] IV. Other Enforcement and Prosecution Issues A. The Doctrine of Equivalents Applied to Amino Acid and DNA Inventions B. Challenges Based on Obviousness C. Miscellaneous Points for Biotechnology Patents Arguments of a Licensee or Potential Licensee Statements Made to Governmental Agencies Inequitable Conduct Patent Exhaustion [New Topic]

15 Detailed Table of Contents xxxiii V. Considerations and Overlap With Regulatory Requirements A. The Orange Book and the Timing of Drug Approvals The Requirements for Listing of Patents in the Orange Book a. Drug Substance Patents b. Drug Product Patents c. Method-of-Use Patents Patents That Must Not Be Submitted a. Process Patents b. Patents Claiming Packaging c. Patents Claiming Metabolites d. Patents Claiming Intermediates B. Patents That May Be Granted Patent Term Extension for Delays Due to Regulatory Delays Mechanics of Filing for and Obtaining an Extension Length of Extension Scope of the Extension C. Follow-On Biologics [New Topic] VI. Conclusion Footnote Updates Chapter 10. Design Patents I. Introduction and Design Law Principles A. Licensing and Enforcement B. Application of Utility Laws and Evolution C. Infringement of Design Patents Introduction Claim Construction Prior Infringement Test Pre-Egyptian Goddess [New Topic] a. Comparison to the Accused Article: Gorham Test b. Comparison to the Accused Article: Point of Novelty Test [Redesignated] Current Infringement Test Post-Egyptian Goddess [New Topic] II. Practice Essentials A. Understanding and Applying the Essential Concepts Introduction Portion Practice

16 xxxiv Drafting Patents for Litigation and Licensing Design Claims Are Not Broad or Narrow Consideration of Multiple Applications Should Be the Rule Design Patents Do Not Protect Concepts B. Sculpting the Design Claim Responsibility and Technique Aesthetic Significance of Features a. KeyStone b. Contessa Functionality of Features Prior Art Considerations [New Topic] C. Creatively Presenting the Design Claim D. Accurately Presenting the Design Claim E. Avoid Multiple Embodiments in a Single Design Patent F. Expanding Options With Strategic Continuation Practice Introduction Utility-Design Priority Design-Utility Priority Design-Design Priority G. Special Considerations Branding Efforts and Nontraditional Articles Protect More Than Just the Core Product Product Packaging Promotional and Peripheral Products Computer Icons and Graphical User Interfaces Type Fonts Physical Settings H. Controlling the Timing General Speeding Up Slowing Down I. Think Globally: How International Practice Affects U.S. Practice III. Conclusion Chapter 11. Combining Prosecution with Other Forms of Representation I. Introduction II. Identifying the Applicable Standards A. Standards Applicable During Prosecution OED Discipline PTO Disqualification

17 Detailed Table of Contents xxxv 3. Preemption by PTO Code B. Federal Circuit Choice of Law C. Conclusion on Choice of Law III. Combining Prosecution and Litigation A. The Possibility of Misuse of Discovery Materials While Prosecuting Applications Is Prosecution of Patents by Itself Sufficient to Bar Access to Highly Confidential Information? a. In re Sibia b. The Majority View c. A Suggested Analysis A Proposed Prosecution Bar Raises Potential Conflicts and Liability Issues to Consider in Crafting Protective Orders B. Liability and Disqualification of Prosecuting- Litigators Inequitable Conduct as a Conflict Depositions of Prosecuting-Litigators C. Advocate-as-Witness Disqualification IV. Combining Opinion and Trial Representations A. Advocate-as-Witness Disqualification The Courts Split on Advocate-as-Witness Disqualification What to Do B. Enhanced Risk of Waiver of Work Product C. What to Do V. Conclusion Footnote Updates Chapter 12. Drafting U.S. Patents With a View Toward Europe I. Introduction A. Brief History of the Development of the EPO B. Applicable Law II. Requirements for the Description of an EPO Application A. Sufficiency of Disclosure Article 83 EPC B. Content of the Application Rule 42 EPC C. Summary III. The Claims A. Overview B. Content of the Claims Article 84 EPC

18 xxxvi Drafting Patents for Litigation and Licensing 2012 C. Rule 43(1) EPC Two-Part Characterized Form Preferred Two-Part Form Not Needed for Filing Two-Part Form Only Whenever Appropriate D. Only One Independent Claim of Each Category Permitted Except in Special, Limited Circumstances Plurality of Interrelated Products (Rule 43(2)(a)) Plurality of Different Inventive Uses of a Product or Device (Rule 43(2)(b)) Alternative Solutions to a Particular Problem (Rule 43(2)(c)) E. Dependent Claims Permitted F. The Dependent Claims Can Be Multiple Dependent Claims G. No Limit on the Number of Claims H. The Claims Should Preferably Include Reference Numerals IV. Unity of Invention A. Lack of Unity a Priori and a Posteriori B. Claims of Different Categories C. Divisional Applications V. Other Issues Concerning the Claims A. Alternatives and Markush Groupings B. Jepson Claims C. Means for Language D. Computer Implemented Inventions and Business Methods E. Beauregard Claims F. Product-by-Process Claims G. Method of Treatment Claims First Medical Use Claims Second Medical Use or Swiss Claims EPC 2000 The End of Swiss Claims Practical Advice on Claim Drafting for Methods of Treatment H. The EP Approach to Added Matter Claim Drafting Ramifications I. Continuation and Divisional Applications Continuation Applications CIP Applications VI. Practical Guidance VII. When to Revise the Specification A. Paris Convention Route

19 Detailed Table of Contents xxxvii B. Ex-PCT Route VIII. Post-grant Issues [New Topic] A. The Extent of Protection [New Topic] Harmonization of Different Traditional National Approaches [New Topic] Equivalents [New Topic] B. File Wrapper Estoppel [New Topic] C. Forum Shopping [New Topic] Appendix A Appendix B Appendix C Table of Cases Index

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