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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 .............. 1 1-1

I. Introduction .................................................................. 2 — II. Applicants Bear the Burden to Draft Carefully ............ 3 1-2

A. Obvious, Harmless Errors Are Correctible ............ 4 1-3B. Serious Errors Are Not Correctible ........................ 5 1-3C. Avoiding Indefiniteness Requires “Reasonable

Certainty” of Scope [Revised Heading] .................. 8 1-3 III. Claim Construction ....................................................... 10 1-7

A. Standard of Review .................................................. 10 1-7B. Phillips v. AWH ......................................................... 12 —C. General Claim Construction Principles ................. 17 1-9

1. Applicant as Lexicographer ............................ 17 1-92. Disclaimer of Claim Scope .............................. 18 1-93. Preamble Terms and Transitional

Phrases .............................................................. 22 1-134. Context of Other Claims (Claim

Differentiation) ................................................ 25 1-145. Means-Plus-Function Limitations .................... 27 1-156. Other Claim Construction Principles ............. 30 1-17

D. PTO Applies Broadest Reasonable Interpretation .......................................................... 34 1-18

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IV. Infringement—Direct and Indirect ............................. 37 1-19A. Direct Infringement: Literal Infringement ........... 37 1-19

1. All Limitations Must Be Satisfied .................... 40 1-202. Extraterritorial Acts Can Infringe ................... 41 1-213. The Evidentiary Burden at Trial ..................... 42 —

B. Direct Infringement: Doctrine of Equivalents ....... 43 1-211. Determining Equivalence: Insubstantial

Difference and Triple Identity ......................... 45 —2. Bars to the Doctrine of Equivalents ................ 47 1-21

a. Prosecution History Estoppel .................... 49 1-21 i. Rebutting the Festo Presumption ........ 51 1-21

b. The All-Elements Rule (“Vitiation” and “Specific Exclusion”) .................................. 54 1-22

C. Indirect Infringement ............................................. 56 1-231. Active Inducement Under

Section 271(b) ................................................. 58 1-232. Contributory Infringement Under

Section 271(c) ................................................... 60 —3. Extraterritorial Indirect Infringement ............ 61 —

V. Conclusion ...................................................................... 63 1-24

Chapter 2. Pitfalls in Patent Drafting ...................... 45 2-1

I. Introduction .................................................................. 69 2-3 II. Pitfalls in Drafting the Specification ............................ 71 2-3

A. Specifications Having Narrow Descriptions .......... 71 2-31. Titles Having Unnecessary Verbiage .............. 72 2-32. Narrow Field of the Invention/

Background of the Invention/Prior Art ......... 73 —3. Narrow Abstracts .............................................. 76 2-44. Narrow Summary of the Invention ................. 78 —5. Specific Problems in the Specification and

Drawings ........................................................... 79 2-5a. “Objects of the Invention” and Similar

Characterizations ........................................ 79 2-5b. Criticizing Prior Art in the

Specification ............................................... 82 2-5c. Use of Language Implying Criticality ........ 85 —d. Unintentional Definitions of Claim

Terms ........................................................... 88 2-6e. Disclosing Only a Single Embodiment

of the Invention .......................................... 94 —f. Referring to “The Invention” ..................... 95 —g. The “Dedicated to the Public”

Doctrine ...................................................... 97 —

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h. Referring to Prophetic Examples in the Patent ........................................................... 100 —

B. Failure to Provide Sufficient Written Description/Enablement Support ......................... 101 —1. Claim Overspecificity ....................................... 103 —2. Claim Overbreadth .......................................... 104 —

C. Potential Pitfalls With Provisional Patent Applications .............................................................. 107 2-61. Failure to File Foreign Applications Within

One Year of Provisional Filing ........................ 107 —2. Filing Provisionals for the Wrong

Reasons ............................................................. 108 —3. Dangers of “As-Is” Filings ................................ 109 2-64. Failure to Establish Ownership for

Provisionals ....................................................... 109 —5. Failure to Claim Subject Matter Supported

Entirely by the Provisional Filing .................... 110 —6. Failure to Carry Over All Subject Matter

From Provisional Into Nonprovisional ........... 112 — III. Pitfalls in Claim Drafting ............................................... 112 2-6

A. Uncertainty Regarding Whether a Preamble Is “Limiting” ................................................................ 113 —

B. Claims That Are Broader Than the Disclosure or Not Commensurate in Scope With the Disclosure ................................................................ 115 —

C. Use of Claim Terminology That Can Change Over Time ................................................................ 118 —

D. Multiparty Infringers and Divided Infringement Claims ............................................... 119 2-6

E. Pitfalls of Means-Plus-Function Claims .................. 127 2-81. Unintended Means-Plus-Function

Clauses .............................................................. 128 2-82. Attempted Means-Plus-Function Clauses

Not Interpreted as Such ................................... 130 2-103. Single-Means Claims ........................................ 132 —4. Failure to Clearly Link Structure in the

Specification to the Recited Function ............ 133 —5. Insufficiently Described Corresponding

Structure ........................................................... 135 2-10F. “Functional” Claiming ............................................ 138 2-10G. Territorial Scope Problems ..................................... 142 —H. Indeterminate Scope of “Whereby” Clauses .......... 145 —I. Definiteness Problems ............................................ 147 2-11

1. Use of Relative Terminology ........................... 148 2-11

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2. Failure to Provide Antecedent Basis for Claim Elements ................................................ 152 —

3. Failure to Define “Coined” Terminology ........ 153 2-11J. Failure of a Dependent Claim to Further Limit

a Parent Claim ......................................................... 153 —K. Use of Jepson-Type Claims ...................................... 155 —L. Reciting Operating Conditions or Usage in

Apparatus Claims .................................................... 156 2-12M. Reciting Human Activities in Claims ..................... 158 —

IV. Pitfalls in Patent Prosecution ........................................ 159 2-13A. Prosecution Disclaimer ........................................... 159 2-13B. Amendment-Based Estoppel .................................. 161 2-15C. Argument-Based Estoppel ...................................... 163 —D. How to “Festo-Proof” a Patent Application ............. 164 —E. Clearly Link Arguments to Specific Claims ........... 167 —

V. Other Problems Affecting Patent Rights or Scope .............................................................................. 168 2-15A. Failure to Investigate Potential Bars to

Patentability ............................................................. 168 2-15B. Failure to Correctly Determine Inventorship

or to Establish Ownership ...................................... 172 2-17C. Failure to Claim the Commercial

Embodiment ............................................................ 177 —D. Failure to Mark Patent Numbers on Covered

Devices ..................................................................... 178 —E. Failure to Proofread the Issued Patent .................. 181 2-17

VI. Conclusion ..................................................................... 181 —

Chapter 3. Drafting the Winning Patent ................... 147 3-1

I. Introduction ................................................................... 185 — II. Patent Application Drafting—A Stepped

Approach ........................................................................ 185 3-3A. STEP 1: Be Able to Write Clearly ............................ 186 3-3B. STEP 2: Thoroughly Understand U.S. Patent

Law and USPTO Procedures and Have a Working Knowledge of Applicable International Patent Practice .................................. 188 3-4

C. STEP 3: Thoroughly Understand the Invention .................................................................. 189 3-51. The Invention Disclosure Meeting .................. 190 3-5

a. Preparing for an Invention Disclosure Meeting ........................................................ 190 3-5

b. Conducting an Invention Disclosure Meeting ........................................................ 193 3-5 i. Avoid Legal Jargon .............................. 193 3-5

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ii. Take Good Notes ................................. 195 — iii. Be Aware of Time-Sensitive

Matters ................................................. 195 — iv. Draft a Sample Claim .......................... 196 3-6 v. Determine Inventorship ..................... 197 — vi. Ask About Reduction to Practice ....... 200 —

2. Searching for Prior Art ..................................... 201 —D. STEP 4: Draft an Initial Set of Working

Claims ....................................................................... 202 3-61. Claim Drafting Generally ................................. 203 3-62. Determine What to Include in the

Independent Claims ......................................... 204 —3. Include as Many Claim Types as Possible ........ 206 3-64. Targeting Infringers in Advance: Who

Will Infringe the Claim? ................................... 208 —5. Selecting Dependent Claim Features .............. 208 —

E. STEP 5: Prepare Working Drawing Figures (If the Application Will Include Drawings) ............ 209 —

F. STEP 6: Draft the Detailed Description Portion of the Specification..................................... 213 3-71. Things to Remember ........................................ 213 —2. Thoughtfully and Logically Organize the

Specification ...................................................... 214 —3. Avoid Unnecessary Repetition ......................... 216 —4. Do Not Assume That the Reader Is

Starting From the Same Knowledge Base ....... 217 —5. Strive for Clarity and Readability, but

Remember Claim Construction During Litigation ........................................................... 217 3-7

6. Include Multiple Embodiments and Examples ........................................................... 219 —

7. Use Self-Serving Statements and Boilerplate ......................................................... 221 —

8. Include Broad Definitions of Claim Terms ................................................................. 223 3-7

9. Use Terminology Consistently in the Specification and Claims .................................. 225 —

10. Favor Over-Inclusion Rather Than Under-Inclusion ................................................ 226 —

11. Use Incorporation by Reference Carefully ............................................................ 228 —

12. Provide Support for Any Means-Plus- Function Claims ................................................ 230 3-7

G. STEP 7: Draft the Summary Portion of the Specification ............................................................. 231 —

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H. STEP 8: Draft the Background Portion of the Specification ............................................................. 233 —

I. STEP 9: Revise the Claims ....................................... 234 3-81. Recite a Minimum Number of Elements

in Independent Claims ..................................... 234 —2. Include Claims of Broad, Intermediate,

and Narrow Scope ............................................ 235 3-83. How Many Claims Are Appropriate? ............... 237 3-84. Use a Variety of Claim Terminology

Consistent With the Specification .................... 238 —5. Rely on Claim Differentiation to Maximize

Claim Scope ...................................................... 239 —6. Carefully Select Preamble and Transition

Phrases ............................................................... 240 —7. Try to Design Around Your Own Claims ......... 242 —8. Using Terms of Approximation ....................... 242 3-89. Carefully Consider Linkages Among

Elements ............................................................ 243 —10. Avoiding Indemnity Agreements Among

Vendors .............................................................. 245 3-811. Maximizing Damages and Royalties

Through Claim Drafting .................................. 248 3-12J. STEP 10: Proofread the Specification, Claims

and Drawings ............................................................ 250 —K. STEP 11: Revise the Application Based on

Inventor Review and Then Proofread It Again ......................................................................... 251 —

III. Checklists for Drafting and Prosecution ....................... 251 3-13A. Pre-Drafting Checklist .............................................. 251 —B. Pre-Filing Checklist .................................................. 251 3-13C. Checklist for Official Filing Receipt and

Recorded Assignment .............................................. 254 —D. Checklist for First Office Action .............................. 255 —E. Checklist for Patent Prosecution ............................. 256 —F. Checklist for Notice of Allowance ........................... 256 —G. Checklist for Granted Patent ................................... 257 —

IV. Conclusion ...................................................................... 257 —

Chapter 4. Continued Prosecution of the Patent .... 259 4-1

I. Introduction ................................................................... 260 — II. The Family of Continuing Applications ....................... 262 4-2

A. Continuations .......................................................... 262 4-21. Earlier Application Must Satisfy

35 U.S.C. §112(a) .............................................. 264 —2. Requirement for at Least One Common

Inventor ............................................................. 265 —

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3. Copendency Requirement .............................. 265 —4. Specific Reference Requirement .................... 268 4-45. Continuity of Disclosure ................................... 269 —

B. Continuations-in-Part (CIPs) .................................. 270 4-4C. Divisionals ................................................................ 273 4-5D. Continuing Prosecution Strategy ........................... 277 4-8

III. Prosecution Laches ....................................................... 277 — IV. Certificates of Correction .............................................. 282 4-10 V. Reissues .......................................................................... 284 4-11

A. The Patent for the Invention .................................. 285 4-11B. Through Error, Patent Deemed Wholly or

Partly Inoperative or Invalid [Revised Heading] ................................................... 286 4-111. Errors Generally ................................................ 287 4-112. Recapture .......................................................... 289 —

C. Broadening Reissue ................................................ 294 4-12D. Intervening Rights ................................................... 295 —E. Reissue Strategy ....................................................... 297 —

VI. Reexaminations ............................................................. 297 4-13A. Ex Parte Reexamination ......................................... 299 4-13

1. The Request ...................................................... 299 4-132. Institution of Ex Parte Reexamination ........... 300 —3. Patent Owner Response .................................. 302 —4. Prosecution of Ex Parte Reexamination ........ 303 4-135. Appeal and Certificate ..................................... 306 4-14

B. Inter Partes Reexamination .................................... 307 4-141. The Request ..................................................... 307 —2. Institution of Inter Partes

Reexamination .................................................. 309 —3. Patent Owner Response .................................. 309 —4. Prosecution of Inter Partes

Reexamination ................................................. 310 4-145. Appeal and Certificate ..................................... 311 4-146. Third-Party Estoppel ........................................ 312 —

C. Intervening Rights ................................................... 313 4-15D. Reexamination Strategy .......................................... 316 4-16

1. Cost ................................................................... 316 —2. Strengthening the Patent ................................ 317 —3. Adding More Claims ........................................ 317 4-164. Patent Owner Requests ................................... 317 —5. Stays of Litigation ............................................. 318 4-16

VII. Supplemental Examination .......................................... 318 —A. Scope of and Procedures for Supplemental

Examination ............................................................. 319 —B. Modified Ex Parte Reexamination Procedures

Following Supplemental Examination ................... 322 —

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C. PTO Discovery of Fraud .......................................... 323 —D. Supplemental Examination’s Impact on

Litigation and Enforcement Strategies .................. 324 — VIII. Conclusion ..................................................................... 326 —

Chapter 5. Mechanical Patents ..................................... 327 5-1

I. Introduction .................................................................. 328 5-3 II. Validity of Mechanical Patents ...................................... 330 5-4

A. Written Description Issues ...................................... 331 5-41. The Traditional Rule: Mechanical

Technologies Are Predictable ......................... 332 5-42. Predictability in the Mechanical Arts After

Gentry Gallery .................................................... 333 —3. Don’t Rely on Predictability for

Mechanical Technologies ................................ 335 5-5B. Enablement Issues ................................................... 339 —C. Definiteness Issues .................................................. 341 5-5

1. The Pre-Nautilus Standard for Indefiniteness—“Insolubly Ambiguous” [New Topic] ...................................................... — 5-5

2. The Nautilus Standard for Indefiniteness—“Reasonable Certainty” [New Topic] ...................................................... — 5-8

3. Terms of Degree and Other Potential Indefiniteness Problems in Mechanical Patents [New Topic] ......................................... — 5-11

D. Obviousness Issues .................................................. 351 5-18 III. Claim Scope and Interpretation of Mechanical

Patents ............................................................................ 356 5-18A. Ordinary Meaning ................................................... 356 5-19 B. Avoiding Narrow Claim Scope ............................... 359 5-21

1. The Critical Importance of the Written Description ....................................................... 362 —

2. Maximizing Claim Scope in Mechanical Patents ............................................................... 364 5-22a. Disclose and Claim Multiple

Embodiments ............................................... 366 5-22b. Use Equivocal Language in the

Specification ................................................ 372 5-24c. Pursue Claims of Differing Scope and

Type .............................................................. 377 5-26d. Avoid Describing Any Particular

Feature, Aspect, or Embodiment as “The Invention” in the Specification ......... 382 5-27

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e. Avoid Emphasizing Any Particular Object, Advantage, or Feature of the Invention in the Specification ................... 383 5-29

f. Avoid Describing the Invention Narrowly in Any “Summary of the Invention” ................................................... 386 5-31

g. Avoid Undue Emphasis Distinguishing Over the Prior Art ....................................... 387 5-31

h. Drawing Features Should Be Explained .................................................... 389 5-32

C. Means-Plus-Function Limitations in Mechanical Patents ................................................. 394 5-331. Careful Use of Means-Plus-Function

Claiming in Mechanical Cases ........................ 395 5-33 2. Avoid Recitation of Structure .......................... 397 —3. Disclose Multiple Embodiments of

Corresponding Structure ................................ 399 5-334. Always Clearly Link Corresponding

Structure to the Claimed Functions ............... 404 5-345. Avoid Unintentional Invocation of

Section 112(f) .................................................. 406 5-35 6. The Mysterious and Elusive Step-Plus-

Function Claim ................................................ 409 5-37 IV. Other Enforcement Issues ............................................ 410 5-38

A. Some Sage Advice from the Federal Circuit Regarding Claim Drafting ...................................... 411 5-38

B. In Mechanical Cases, It May Be Difficult to Rebut the Festo Presumption .................................. 416 5-38

V. Conclusion ..................................................................... 420 —

Chapter 6. Electrical Patents ....................................... 421 6-1

I. Introduction .................................................................. 422 — II. Drafting Electrical Patent Specifications ..................... 422 6-2

A. Statutory Considerations ........................................ 423 6-21. Utility ................................................................ 423 6-22. Enablement and Written Description ............ 424 —

a. “Predictability” ............................................ 424 —b. Problems with Claims Broader Than

the Specification ......................................... 425 —B. Limiting Statements in the Specification ............... 432 6-3C. Characterizing “The Invention” ............................. 440 6-7D. Ensure Sufficient Support for Electrical

Structures ................................................................. 444 6-8 III. Claim Drafting Strategies .............................................. 454 6-8

A. Systems Including Paired Operations .................... 455 —

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B. Components of a System ........................................ 459 —C. Multiple Party Issues ............................................... 461 6-8D. Method Steps Performed Outside of the

United States ............................................................ 464 —E. Make Sure Claims Accurately Describe the

Invention ................................................................. 465 —F. Transitional Phrases ................................................ 468 —G. Problems With Means-Plus-Function Clauses ........ 469 6-9H. Time-Dependent Terminology ............................... 473 —I. Use the Term “Or” Carefully .................................. 474 —J. Use Absolute Terms Carefully ................................ 475 6-12K. Definiteness Problems ............................................ 476 6-13L. Claims to Semiconductor Devices .......................... 479 —M. Draft Claims of Different Scope ............................. 480 —

IV. Conclusion ..................................................................... 481 —

Chapter 7. Software, E-Commerce, Internet, and Business Method Patents ............................ 483 7-1

I. Introduction .................................................................. 485 — II. Validity of Software-Related Patents ............................. 486 7-3

A. Written Description Issues ...................................... 486 —B. Enablement Issues ................................................... 490 —C. Best Mode Issues ..................................................... 492 —D. Definiteness Issues .................................................. 494 7-3

1. Means- or Step-Plus-Function Recitations ....... 497 7-3E. Patent-Eligible Subject Matter Issues ..................... 503 7-5

1. Supreme Court Precedent .............................. 503 7-5a. Benson: Unpatentable Algorithm ............... 504 —b. Flook: Another Unpatentable

Algorithm .................................................... 505 —c. Chakrabarty: Patentable Micro-

Organism ..................................................... 507 —d. Diehr: Finally, a Patentable Algorithm ........ 507 —e. Bilski: Unpatentable Abstract Idea .............. 509 —f. Alice: A New Test [New Topic] ................... — 7-5

2. Current Tests to Determine Statutory Subject Matter .................................................. 512 7-8a. The Abstract Idea Test ................................. 513 7-8

i. Supreme Court Precedent .................. 513 — ii. Alappat, State Street Bank, and

AT&T ................................................... 515 — iii. In re Warmerdam ................................... 516 — iv. Research Corp. ........................................ 518 — v. Applying the Abstract Idea Test

Under Alice [New Topic] .................... — 7-8

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1. The First Step Under Alice [New Topic] ........................................... — 7-8

2. The Second Step Under Alice [New Topic] ........................................... — 7-13

vi. USPTO Guidelines [Renumbered Subsection] .......................................... 519 7-16

vii. Summary [Renumbered Subsection] .......................................... 521 7-23

b. The Machine-or-Transformation Test ......... 522 — i. In re Bilski ............................................. 522 — ii. Ferguson ............................................... 525 —

iii. SiRF Technology .............................. 526 — vi. USPTO Guidelines ....................... 528 — v. Summary ......................................... 529 —

3. Previous Tests to Determine Statutory Subject Matter .................................................. 530 —a. The Freeman-Walter-Abele Test ...................... 530 —b. The Business Method Test ......................... 531 —c. The Technological Arts Test ...................... 533 —d. The “Useful, Concrete, and Tangible

Result” Test .................................................. 535 —e. The Physical Steps Test ............................... 536 —f. The Transformation Test ............................ 537 —

i. Supreme Court Precedent ................. 537 — ii. Arrhythmia .......................................... 539 —

g. The Practical Application Test .................... 541 — III. Claim Scope and Interpretation of Software-

Related Patents .............................................................. 544 7-23A. Claims for Software-Related Inventions ................. 544 7-23

1. Process Claims .................................................. 545 —a. Process Claims Interacting With the

Physical World ............................................. 545 —b. Process Claims With No Interaction

With the Physical World ............................. 549 —2. Apparatus Claims ............................................. 552 —3. System Claims ................................................... 553 —4. Claims with Means- or Step-Plus-Function

Recitations ........................................................ 557 7-235. Data Structure Claims ...................................... 564 —6. Computer-Readable Medium Claims ............. 566 —7. Signal Claims .................................................... 570 —8. Software Module Claims .................................. 575 —9. Paradigm Claims .............................................. 576 —

B. Business Method Inventions ................................... 577 7-24

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1. Software-Related Business Method Inventions ......................................................... 577 7-24

2. Non-Software-Related Business Method Inventions .......................................................... 585 7-25

3. Post-Grant Review of Business Method Patents .............................................................. 588 7-26

4. Summary .......................................................... 589 —C. Claiming Strategies ................................................. 589 7-27

1. Claiming a Network or Internet Invention .......................................................... 589 7-28

2. Claiming a Network Router Invention ........... 593 —3. Claiming an E-Commerce Web Site

Invention .......................................................... 594 —4. Claiming a Simulation Software

Invention .......................................................... 597 — IV. Conclusion .................................................................... 599 —

Chapter 8. Chemical and Pharmaceutical Patents ........................................................... 601 8-1

I. Introduction .................................................................. 603 — II. Validity of Chemical and Pharmaceutical Patents ........ 603 8-3

A. Written Description Issues ...................................... 603 8-3B. Enablement Issues ................................................... 608 —C. Best Mode Issues ..................................................... 611 —D. Utility Issues ............................................................. 614 —E. Patentable Subject Matter ....................................... 616 —F. Anticipation Issues in Chemical Applications:

Inherency ................................................................. 618 8-31. Inherent Anticipation Is Not Avoided by

Discovery of a New Benefit or Property of an Old Material or Method ............................. 619 —

2. Metabolite Claims Can Be Anticipated If the Metabolite Was Formed In Vivo After Administration of the Prior Art Drug ............. 620 —

3. Creative Claim Drafting Can Often Overcome Inherent Anticipation Problems ........................................................... 622 —

4. A Sufficiently Small Prior Art Genus Can Anticipate a Later-Claimed Species ................ 623 8-3

G. Obviousness Issues in Chemical and Pharmaceutical Patents ........................................... 626 8-41. Pre-KSR Standards for Chemical

Obviousness ....................................................... 627 —2. Post-KSR Chemical Obviousness ..................... 628 8-5

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H. Double Patenting Issues in Chemical Cases .......... 633 — III. Claim Scope and Interpretation of Chemical and

Pharmaceutical Patents ................................................. 636 8-5A. Claim Scope Issues in Chemical and

Pharmaceutical Patents ........................................... 636 8-51. Product-by-Process Claims ............................... 636 8-52. Markush Groups .............................................. 638 —

a. Markush Group Members Must Share Some Relationship to Be Grouped Together Properly ....................................... 638 —

b. Careful Wording of a Markush Claim Is Necessary ................................................. 640 —

c. Provide Supporting Disclosure and Working Examples ...................................... 641 —

3. Transitional Phrases in Chemical Claims ........ 644 8-5B. Means-Plus-Function Limitations ........................... 648 —C. Claim Drafting Strategies ........................................ 649 8-6

1. A Careful Review of the Chemical Invention Can Ensure That Claims to All Aspects of the Invention Are Included ........... 649 —a. Consider the Existence of Metabolic

Forms When Claiming a Compound ......... 652 —b. In Pharmaceutical Patents, Consider

“Label Claims” That Protect Specific Methods or Uses in the FDA-Approved Prescribing Information ............................. 653 —

c. Use Care in Claiming a Polymorphic Form in Terms of Its Analytical Properties .................................................... 653 —

d. Consider Whether Salt Forms of a Compound Are Intended to Be Encompassed Within the Claim to the Free Acid or Base ........................................ 655 —

2. Pharmaceutical Claims to Methods of Treatment .......................................................... 657 8-6

3. Pharmaceutical Claims to Homologs, Racemates, Salt Forms, and Metabolites ........ 658 —

D. Claim Interpretation ............................................... 658 8-71. Implicit and Explicit Definitions of Claim

Terminology ..................................................... 659 8-72. The Effect of Examples and Preferred

Embodiments on Claim Construction ............ 664 8-83. Interrelationship of Claims ............................. 668 8-94. Prosecution History: Disclaimers and

Estoppel ............................................................ 669 8-9

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5. Use of Extrinsic Evidence in Interpreting Chemical Claims .............................................. 672 —

IV. Conclusion ..................................................................... 676 —

Chapter 9. Biotechnology Patents .............................. 677 9-1

I. Introduction ................................................................... 679 — II. Validity Issues Related to Biotechnology Patents ......... 679 9-3

A. Considerations Under 35 U.S.C. Section 101 ........ 679 9-31. Patent-Eligible Subject Matter ........................ 679 9-4

a. Mayo Collaborative Services v. Prometheus Laboratories, Inc. [Amended Heading] ................................... 679 9-4

b. Association for Molecular Pathology v. Myriad Genetics, Inc. [New Heading] ............................................ 683 9-5

c. Subject Matter Eligibility Guidelines [New Heading] ............................................ — 9-5

d. Federal Circuit Decisions [New Heading] ........................................... — 9-6 i. In re Roslin Institute (Edinburgh)

[New Heading] ................................... — 9-6 ii. In re BRCA1- and BRCA2-Based

Hereditary Cancer Test Patent Litigation [New Heading] ................... — 9-7

iii. Ariosa Diagnostics, Inc. v. Sequenom, Inc. [New Heading] ............ — 9-9

iv. Genetic Technologies Ltd. v. Merial L.L.C. [New Heading] ............. — 9-11

v. Rapid Litigation Management Ltd. v. CellzDirect, Inc. [New Heading] .................................... — 9-12

2. Utility ................................................................. 687 —B. Considerations Under 35 U.S.C. Section 112 ........ 688 9-13

1. Enablement as of the Date of Filing and After-Arising Technology ................................. 688 —

2. Written Description and Biological Organisms Deposited With the ATCC ............ 690 —

3. Written Description and DNA-Based Inventions .......................................................... 691 —

4. Written Description of Antibodies ................... 692 9-135. Indefiniteness [New Heading] ........................ — 9-14

C. Post Grant Review Under the AIA........................... 693 — III. Claim Scope and Interpretation of Biotechnology

Patents ............................................................................ 694 9-15A. Claim Scope Is Fixed as of the Filing Date ............ 694 —

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B. Process Limitations and Product Claims ............... 697 —C. Interpreting Claims in Light of the

Specification ............................................................ 699 9-161. Multiple Interpretations of a Claim Versus

a Single, Unambiguous Meaning .................... 699 —2. 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 ......................... 700 —

3. Avoiding Restriction of the Invention to the Disclosed Preferred Embodiment ............ 702 9-16

4. Relative Terms: “Substantially,” “About,” and “At Least” .................................................. 705 —

5. Calculations ...................................................... 706 —D. The Role of the Preamble in Biotechnology

Claims ...................................................................... 707 —1. Griffin v. Bertina ................................................ 707 —2. Manning v. Paradis ........................................... 708 —3. Rapoport v. Dement and Jansen v. Rexall

Sundown, Inc. .................................................... 709 —4. In Re Cruciferous Sprout Litigation .................... 710 —5. Boehringer Ingelheim Vetmedica, Inc. v.

Schering-Plough Corp. .................................... 711 —E. Nontraditional Claim Language ............................ 711 —F. Joint or Divided Infringement of Process

Claims ....................................................................... 712 9-17 IV. Other Enforcement and Prosecution Issues ................ 713 —

A. The Doctrine of Equivalents Applied to Proteins and Nucleic Acid Molecules .................... 713 —

B. Challenges Based on Obviousness ......................... 715 —C. Miscellaneous Points for Biotechnology

Patents ...................................................................... 717 —1. Arguments of a Licensee or Potential

Licensee ............................................................ 717 —2. Statements Made to Governmental

Agencies ........................................................... 718 —3. Inequitable Conduct ........................................ 719 —4. Patent Exhaustion ............................................ 719 —

V. Considerations and Overlap With Regulatory Requirements ................................................................. 721 9-19A. The Orange Book and the Timing of Drug

Approvals ................................................................. 721 —1. The Requirements for Listing of Patents

in the Orange Book ......................................... 722 —a. Drug Substance Patents .............................. 722 —b. Drug Product Patents ................................. 724 —

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c. Method-of-Use Patents ............................... 724 —2. Patents That Must Not Be Submitted ............. 725 —

B. Patents That May Be Granted Patent Term Extension for Delays Due to Regulatory Delays ....................................................................... 726 —1. Length of Extension ........................................ 728 —2. Scope of the Extension .................................... 729 —

C. Follow-On Biologics ................................................. 730 9-19 VI. Conclusion ..................................................................... 732 —

Chapter 10. Design Patents .............................................. 735 10-1

I. Introduction and Design Law Principles ..................... 736 —A. Licensing and Enforcement ................................... 737 —B. Application of Utility Laws and Evolution ............. 738 —C. Infringement of Design Patents ............................. 739 —

1. Introduction ..................................................... 739 —2. Claim Construction ......................................... 739 —3. Prior Infringement Test—Pre-Egyptian

Goddess .............................................................. 742 —a. Comparison to the Accused Article:

Gorham Test ................................................. 742 —b. Comparison to the Accused Article:

Point-of-Novelty Test ................................... 743 —4. Current Infringement Test—Post-Egyptian

Goddess ............................................................... 744 — II. Practice Essentials .......................................................... 748 10-2

A. Understanding and Applying the Essential Concepts ................................................................... 748 —1. Introduction ..................................................... 748 —2. Portion Practice ............................................... 748 —3. Design Claims Are Not Broad or Narrow ....... 749 —4. Consideration of Multiple Applications

Should Be the Rule .......................................... 753 —5. Design Patents Do Not Protect Concepts ........ 753 —

B. Sculpting the Design Claim .................................... 754 10-21. Responsibility and Technique ......................... 754 —2. Aesthetic Significance of Features .................. 756 —

a. KeyStone ........................................................ 757 —b. Contesssa ....................................................... 761 —

3. Functionality of Features ................................. 763 10-24. Prior Art Considerations .................................. 770 —

C. Creatively Presenting the Design Claim ................ 772 —D. Accurately Presenting the Design Claim ............... 772 —E. Avoid Multiple Embodiments in a Single

Design Patent ........................................................... 776 10-3

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F. Expanding Options With Strategic Continuation Practice .............................................. 778 10-61. Introduction ..................................................... 778 —2. Utility-Design Priority ...................................... 779 —3. Design-Utility Priority ...................................... 779 —4. Design-Design Priority ..................................... 779 10-6

G. Special Considerations—Branding Efforts and Nontraditional Articles ............................................ 781 10-81. Protect More Than Just the Core

Product ............................................................. 781 —2. Product Packaging ........................................... 782 —3. Promotional and Peripheral Products ........... 783 —4. Computer Icons and Graphical User

Interfaces .......................................................... 784 10-85. Type Fonts ......................................................... 785 —6. Physical Settings ............................................... 786 —

H. Controlling the Timing ........................................... 787 —1. General .............................................................. 787 —2. Speeding Up ..................................................... 788 —3. Slowing Down .................................................... 789 —

I. Think Globally: How International Practice Affects U.S. Practice ................................................. 790 —

III. Conclusion ..................................................................... 791 —

Chapter 11. Combining Prosecution with Other Forms of Representation ............................ 793 11-1

I. Introduction .................................................................. 794 — II. Identifying the Applicable Standards ........................... 794 11-2

A. Standards Applicable During Prosecution ............ 797 11-41. OED Discipline ................................................ 798 11-42. PTO Disqualification ....................................... 798 11-63. Preemption by PTO Code and USPTO

Rules [Revised Topic Heading] ....................... 800 11-7B. Federal Circuit Choice of Law ................................ 803 11-9C. Conclusion on Choice of Law ................................ 804 11-10

III. Combining Prosecution and Litigation ....................... 805 11-11A. The Possibility of Misuse of Discovery

Materials While Prosecuting Applications ............. 805 11-111. Is Prosecution of Patents by Itself

Sufficient to Bar Access to Highly Confidential Information? .............................. 807 11-11

2. A Proposed Prosecution Bar Raises Potential Conflicts and Liability ...................... 816 11-15

3. Issues to Consider in Crafting Protective Orders ............................................................... 819 11-15

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B. Liability and Disqualification of Prosecuting- Litigators ................................................................... 825 11-181. Inequitable Conduct as a Conflict .................. 825 —2. Depositions of Prosecuting-Litigators ............. 826 11-18

C. Advocate-as-Witness Disqualification ..................... 828 11-20IV . Combining Opinion and Trial Representations .......... 831 11-20

A. Advocate-as-Witness Disqualification ......................... 831 —1. The Courts Split on Advocate-as-Witness

Disqualification ................................................ 832 —2. What to Do ....................................................... 834 —

B. Enhanced Risk of Waiver of Work Product ........... 835 11-20C. What to Do ............................................................... 842 —

V. Conclusion ..................................................................... 843 11-21

Chapter 12. Drafting U.S. Patents With a View Toward Europe ............................................. 845 12-1

I. Introduction .................................................................. 847 —A. Brief History of the Development of the EPO ....... 847 —B. Applicable Law ........................................................ 849 —

II. Requirements for the Description of an EPO Application ..................................................................... 850 —A. Sufficiency of Disclosure—Article 83 EPC ............. 850 —B. Content of the Application—Rule 42 EPC ............ 850 —C. Summary .................................................................. 852 —

III. The Claims ..................................................................... 852 12-3A. Overview .................................................................. 852 —B. Content of the Claims—Article 84 EPC ................. 854 —C. Rule 43(1) EPC—Two-Part “Characterized”

Form Preferred ........................................................ 854 —1. Two-Part Form Not Needed for Filing ............ 855 —2. Two-Part Form Only “Whenever

Appropriate” .................................................... 855 —D. Only One Independent Claim of Each

Category Permitted Except in Special, Limited Circumstances ........................................... 856 12-31. Plurality of Interrelated Products

(Rule 43(2)(a)) ................................................. 857 —2. Different Uses of a Product or Apparatus

(Rule 43(2)(b)) ............................................... 857 —3. Alternative Solutions to a Particular

Problem (Rule 43(2)(c)) ................................ 857 —E. Dependent Claims Permitted ................................. 857 —F. The Dependent Claims Can Be Multiple

Dependent Claims ................................................... 858 —G. No Limit on the Number of Claims ....................... 859 —

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H. The Claims Should Preferably Include Reference Numerals ............................................... 859 —

IV. Unity of Invention ......................................................... 860 12-3A. Lack of Unity “a Priori” and “a Posteriori” ............ 861 —B. Claims of Different Categories ............................... 861 —C. Divisional Applications ........................................... 861 12-3

V. Other Issues Concerning the Claims ........................... 862 12-3A. Alternatives and Markush Groupings .................... 862 —B. Jepson Claims ............................................................ 862 —C. “Means for” Language ............................................ 862 —D. Computer Implemented Inventions and

Business Methods .................................................... 863 —E. Beauregard Claims .................................................... 864 —F. Product-by-Process Claims ...................................... 864 —G. Method-of-Treatment Claims ................................. 864 —

1. First Medical Use Claims ................................. 865 —2. Second Medical Use or Swiss Claims .............. 866 —3. EPC 2000—The End of Swiss Claims .............. 866 —4. Practical Advice on Claim Drafting for

Methods of Treatment ..................................... 867 —H. Stem Cells ................................................................. 867 —I. The EP Approach to Added Matter—Claim

Drafting Ramifications ............................................. 867 —J. Continuation and Divisional Applications ............. 870 12-3

1. Continuation Applications .............................. 870 12-32. CIP Applications .............................................. 871 —

VI. Practical Guidance ........................................................ 872 — VII. When to Revise the Specification ................................. 873 —

A. Paris Convention Route .......................................... 873 —B. Ex-PCT Route .......................................................... 874 —

VIII. Post-Grant Issues ............................................................ 874 12-4A. The Extent of Protection ........................................ 874 —

1. Harmonization of Different Traditional National Approaches ....................................... 874 —

2. Equivalents ....................................................... 875 —B. Unitary Patents ......................................................... 876 12-4C. File Wrapper Estoppel ............................................ 879 —D. Forum Shopping ..................................................... 880 12-4

Chapter 13 Validity Trials at the Patent Trial and Appeal Board .................................................. 883 13-1

I. Introduction to Post-Issuance Trial Proceedings .......... 884 — II. Trial Procedures Before the Patent Trial and

Appeal Board .................................................................. 885 13-3A. Scheduling ............................................................... 886 13-3

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B. Motions Practice ....................................................... 888 13-31. Motions to Amend [New Topic] ...................... — 13-42. Motions to Exclude [New Topic] ..................... — 13-10

C. Discovery ................................................................... 890 13-101. Initial Disclosures .............................................. 890 13-102. Testimonial Discovery ....................................... 891 13-113. Documentary Discovery .................................... 892 13-12

D. Treatment of Confidential Information ................ 894 13-12E. Use of the Federal Rules of Evidence and

Handling of Exhibits ................................................ 895 13-12F. Oral Argument ......................................................... 896 13-13G. Final Written Decision ............................................ 897 13-14H. Settlement ................................................................. 897 —I. Regulation of Conduct of Counsel and Parties

and Sanctions ........................................................... 898 13-15 III. Inter Partes Review ........................................................... 899 13-18

A. Standing and Other Limitations ............................. 900 13-181. Unavailability of Inter Partes Review While

Post-Grant Review is Available ......................... 901 —2. One-Year Bar .................................................... 901 13-183. Declaratory Judgment of Invalidity .................. 902 13-194. Claim and Issue Preclusion .............................. 902 —5. Prior Art and Arguments Already

Considered By the PTO .................................... 903 13-206. Assignor Estoppel [New Topic] ...................... — 13-217. Sovereign Immunity [New Topic] .................. — 13-21

B. Preliminary Proceedings .......................................... 904 13-221. Overview [New Topic] ..................................... — 13-222. Claim Construction [New Topic] ................... — 13-25

C. Trial Proceedings ..................................................... 905 13-26D. Appeal ...................................................................... 908 —E. Impact on Litigation and Patent Procurement

Strategies ................................................................... 909 13-30 IV. Post-Grant Review ........................................................... 911 13-35

A. Scope of Post-Grant Review ..................................... 912 13-36B. Preliminary Proceedings .......................................... 912 —C. Trial Proceedings ..................................................... 913 —D. Appeal ....................................................................... 914 —E. Impact on Litigation Strategies ............................... 914 —

V. Transitional Program for Covered Business Method Patents .............................................................. 916 13-37A. Legislative Debate Over the Transitional

Program for Covered Business Method Patents and Early Challenges to the Program ........ 916 —1. Legislative History of Section 18 ...................... 916 —

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2. Early Litigation Over Scope of Section 18 Review ................................................................ 920 —

B. Patents Subject to the Transitional Program for Covered Business Method Patents ......................... 920 13-37

C. Key Differences Between Covered Business Method Patent Review and Post-Grant Review ....... 922 13-41

VI. Conclusion ...................................................................... 925 —

Appendix A .............................................................................. 927 —

Appendix B .............................................................................. 945 —

Appendix C ............................................................................... 967 —

Table of Cases ........................................................................ 1027 TC-1

Index ........................................................................................ 1061 —