detailed table of contents - tech transfer...
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Detailed Table of Contents
Contributors ......................................................................... v v
Foreword ................................................................................ vii vii
Preface ..................................................................................... ix ix
Author Biographies ............................................................. xi xiii
Summary Table of Contents ............................................... xix xix
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 1-6
A. Standard of Review .................................................. 10 1-6B. 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 1-124. Context of Other Claims (Claim
Differentiation) ................................................ 25 1-125. Means-Plus-Function Limitations .................... 27 1-146. Other Claim Construction Principles ............. 30 1-16
D. PTO Applies Broadest Reasonable Interpretation .......................................................... 34 1-16
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IV. Infringement—Direct and Indirect ............................. 37 1-17A. Direct Infringement: Literal Infringement ........... 37 1-17
1. All Limitations Must Be Satisfied .................... 40 1-182. Extraterritorial Acts Can Infringe ................... 41 1-183. The Evidentiary Burden at Trial ..................... 42 —
B. Direct Infringement: Doctrine of Equivalents ....... 43 1-191. Determining Equivalence: Insubstantial
Difference and Triple Identity ........................ 45 —2. Bars to the Doctrine of Equivalents ................ 47 1-19
a. Prosecution History Estoppel .................... 49 1-19 i. Rebutting the Festo Presumption ........ 51 1-19
b. The All-Elements Rule (“Vitiation” and “Specific Exclusion”) .................................. 54 1-20
C. Indirect Infringement ............................................. 56 1-201. Active Inducement Under
Section 271(b) ................................................. 58 1-212. Contributory Infringement Under
Section 271(c) ................................................... 60 —3. Extraterritorial Indirect Infringement ........... 61 —
V. Conclusion ..................................................................... 63 1-21
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. Narrow Field of the Invention/
Background of the Invention/Prior Art ......... 73 —3. Narrow Abstracts .............................................. 76 2-34. Narrow Summary of the Invention ................. 78 —5. Specific Problems in the Specification and
Drawings ........................................................... 79 2-4a. “Objects of the Invention” and Similar
Characterizations ........................................ 79 2-4b. Criticizing Prior Art in the
Specification ............................................... 82 —c. Use of Language Implying Criticality ........ 85 —d. Unintentional Definitions of Claim
Terms ........................................................... 88 2-5e. 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 —1. 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 —4. 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 2-5
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 2-5
E. Pitfalls of Means-Plus-Function Claims .................. 127 2-71. Unintended Means-Plus-Function
Clauses .............................................................. 128 2-72. Attempted Means-Plus-Function Clauses
Not Interpreted as Such ................................... 130 2-83. Single-Means Claims ........................................ 132 —4. Failure to Clearly Link Structure in the
Specification to the Recited Function ............ 133 —5. Insufficiently Described Corresponding
Structure ........................................................... 135 2-9F. “Functional” Claiming ............................................ 138 2-9G. Territorial Scope Problems ..................................... 142 —H. Indeterminate Scope of “Whereby” Clauses .......... 145 —I. Definiteness Problems ............................................ 147 2-10
1. Use of Relative Terminology ........................... 148 2-10
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2. Failure to Provide Antecedent Basis for Claim Elements ................................................ 152 —
3. Failure to Define “Coined” Terminology ........ 153 2-10J. 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 2-10M. Reciting Human Activities in Claims ..................... 158 —
IV. Pitfalls in Patent Prosecution ........................................ 159 2-11A. Prosecution Disclaimer ........................................... 159 2-11B. Amendment-Based Estoppel .................................. 161 2-12C. 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 2-12A. Failure to Investigate Potential Bars to
Patentability ............................................................. 168 2-12B. Failure to Correctly Determine Inventorship
or to Establish Ownership ...................................... 172 2-13C. 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 2-14
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 3-5 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 3-51. Claim Drafting Generally ................................. 203 3-52. 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 3-61. 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 3-6
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 3-71. Recite a Minimum Number of Elements
in Independent Claims ..................................... 234 —2. Include Claims of Broad, Intermediate,
and Narrow Scope ............................................ 235 3-73. How Many Claims Are Appropriate? ............... 237 3-74. 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 3-8J. 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 3-10A. Pre-Drafting Checklist .............................................. 251 —B. Pre-Filing Checklist .................................................. 251 3-10C. 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 —
III. Prosecution Laches ....................................................... 277 — IV. Certificates of Correction .............................................. 282 4-8 V. Reissues .......................................................................... 284 4-9
A. The Patent for the Invention .................................. 285 4-9B. Through Error, Patent Deemed Wholly or
Partly Inoperative or Invalid [Revised Heading] ................................................... 286 4-91. Errors Generally ................................................ 287 4-92. Recapture .......................................................... 289 —
C. Broadening Reissue ................................................ 294 4-10D. Intervening Rights ................................................... 295 —E. Reissue Strategy ....................................................... 297 —
VI. Reexaminations ............................................................. 297 4-11A. Ex Parte Reexamination ......................................... 299 4-11
1. The Request ...................................................... 299 4-112. Institution of Ex Parte Reexamination ........... 300 —3. Patent Owner Response .................................. 302 —4. Prosecution of Ex Parte Reexamination ........ 303 —5. Appeal and Certificate ..................................... 306 4-12
B. Inter Partes Reexamination .................................... 307 4-121. The Request ..................................................... 307 —2. Institution of Inter Partes
Reexamination .................................................. 309 —3. Patent Owner Response .................................. 309 —4. Prosecution of Inter Partes
Reexamination ................................................. 310 4-125. Appeal and Certificate ..................................... 311 4-126. Third-Party Estoppel ........................................ 312 —
C. Intervening Rights ................................................... 313 4-13D. Reexamination Strategy .......................................... 316 4-13
1. Cost ................................................................... 316 —2. Strengthening the Patent ................................ 317 —3. Adding More Claims ........................................ 317 4-134. Patent Owner Requests ................................... 317 —5. Stays of Litigation ............................................. 318 4-14
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 5-4B. 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] ...................................................... — 5-7
3. Terms of Degree and Other Potential Indefiniteness Problems in Mechanical Patents [New Topic] ......................................... — 5-11
D. Obviousness Issues .................................................. 351 5-16 III. Claim Scope and Interpretation of Mechanical
Patents ............................................................................ 356 5-17A. Ordinary Meaning ................................................... 356 5-17B. Avoiding Narrow Claim Scope ............................... 359 5-18
1. The Critical Importance of the Written Description ....................................................... 362 —
2. Maximizing Claim Scope in Mechanical Patents ............................................................... 364 5-19a. Disclose and Claim Multiple
Embodiments ............................................... 366 5-20b. Use Equivocal Language in the
Specification ................................................ 372 5-21c. Pursue Claims of Differing Scope and
Type .............................................................. 377 5-23d. Avoid Describing Any Particular
Feature, Aspect, or Embodiment as “The Invention” in the Specification ......... 382 5-23
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e. Avoid Emphasizing Any Particular Object, Advantage, or Feature of the Invention in the Specification ................... 383 5-25
f. Avoid Describing the Invention Narrowly in Any “Summary of the Invention” ................................................... 386 5-26
g. Avoid Undue Emphasis Distinguishing Over the Prior Art ....................................... 387 5-26
h. Drawing Features Should Be Explained .................................................... 389 5-27
C. Means-Plus-Function Limitations in Mechanical Patents ................................................. 394 5-281. Careful Use of Means-Plus-Function
Claiming in Mechanical Cases ........................ 395 5-282. Avoid Recitation of Structure .......................... 397 —3. Disclose Multiple Embodiments of
Corresponding Structure ................................ 399 5-284. Always Clearly Link Corresponding
Structure to the Claimed Functions ............... 404 5-295. Avoid Unintentional Invocation of
Section 112(f) .................................................. 406 5-296. The Mysterious and Elusive Step-Plus-
Function Claim ................................................ 409 5-32 IV. Other Enforcement Issues ............................................ 410 5-32
A. Some Sage Advice From the Federal Circuit Regarding Claim Drafting ...................................... 411 5-32
B. In Mechanical Cases, It May Be Difficult to Rebut the Festo Presumption .................................. 416 5-33
V. Conclusion ..................................................................... 420 —
Chapter 6. Electrical Patents ....................................... 421 6-1
I. Introduction .................................................................. 422 6-2 II. Drafting Electrical Patent Specifications ..................... 422 6-2
A. Statutory Considerations ........................................ 423 6-31. Utility ................................................................ 423 6-32. Enablement and Written Description ............ 424 6-4
a. “Predictability” ............................................ 424 6-4b. Problems with Claims Broader Than
the Specification ......................................... 425 6-5B. Limiting Statements in the Specification .............. 432 6-12C. Characterizing “The Invention” ............................. 440 6-20D. Ensure Sufficient Support for Electrical
Structures ................................................................. 444 6-24 III. Claim Drafting Strategies .............................................. 454 6-34
A. Systems Including Paired Operations .................... 455 6-35
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B. Components of a System ........................................ 459 6-39C. Multiple Party Issues ............................................... 461 6-41D. Method Steps Performed Outside of the
United States ............................................................ 464 6-43E. Make Sure Claims Accurately Describe the
Invention ................................................................. 465 6-44F. Transitional Phrases ................................................ 468 6-47G. Problems With Means-Plus-Function Clauses ........ 469 6-48H. Time-Dependent Terminology ............................... 473 6-52I. Use the Term “Or” Carefully .................................. 474 6-54J. Use Absolute Terms Carefully ................................ 475 6-54K. Definiteness Problems ............................................ 476 6-55L. Claims to Semiconductor Devices .......................... 479 6-58M. Draft Claims of Different Scope ............................. 480 6-59
IV. Conclusion ..................................................................... 481 6-60
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. CLS Bank: A New Test [New Topic] ........... — 7-5
2. Current Tests to Determine Statutory Subject Matter .................................................. 512 7-7a. The Abstract Idea Test ................................. 513 7-7
i. Supreme Court Precedent .................. 513 — ii. Alappat, State Street Bank, and
AT&T ................................................... 515 — iii. In re Warmerdam ................................... 516 — iv. Research Corp. ........................................ 518 —
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v. Applying the Abstract Idea Test [New Topic] ......................................... — 7-7
vi. USPTO Guidelines [Renumbered Subsection] .......................................... 519 7-12
vii. Summary [Renumbered Subsection] .......................................... 521 7-18
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 7-19A. Claims for Software-Related Inventions ................. 544 7-19
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 7-195. 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 7-191. Software-Related Business Method
Inventions ......................................................... 577 7-19
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2. Non-Software-Related Business Method Inventions .......................................................... 585 —
3. Post-Grant Review of Business Method Patents .............................................................. 588 7-20
4. Summary .......................................................... 589 —C. Claiming Strategies ................................................. 589 7-21
1. Claiming a Network or Internet Invention .......................................................... 589 7-21
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
H. Double Patenting Issues in Chemical Cases .......... 633 — III. Claim Scope and Interpretation of Chemical and
Pharmaceutical Patents ................................................. 636 8-5
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A. 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 8-61. Implicit and Explicit Definitions of Claim
Terminology ..................................................... 659 8-62. The Effect of Examples and Preferred
Embodiments on Claim Construction ............ 664 8-83. Interrelationship of Claims ............................. 668 8-84. Prosecution History: Disclaimers and
Estoppel ............................................................ 669 8-95. Use of Extrinsic Evidence in Interpreting
Chemical Claims .............................................. 672 — IV. Conclusion ..................................................................... 676 —
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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 9-3
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 9-4
c. Subject Matter Eligibility Guidelines [New Heading] ............................................ — 9-4 i. Nature-Based Product Claims
[New Heading] .................................... — 9-5 ii. Claims to Combinations of
Nature-Based Products [New Heading] ................................... — 9-7
iii. Therapeutic Method Claims [New Heading] .................................... — 9-7
iv. Diagnostic Method Claims [New Heading] .................................... — 9-8
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 —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 —
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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 9-16 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 9-17A. 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 —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 9-17 VI. Conclusion ..................................................................... 732 —
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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 10-3
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 10-31. Responsibility and Technique ......................... 754 —2. Aesthetic Significance of Features .................. 756 —
a. KeyStone ........................................................ 757 —b. Contesssa ....................................................... 761 —
3. Functionality of Features ................................. 763 10-34. 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 —F. Expanding Options With Strategic
Continuation Practice .............................................. 778 —1. Introduction ..................................................... 778 —2. Utility-Design Priority ...................................... 779 —3. Design-Utility Priority ...................................... 779 —4. Design-Design Priority ..................................... 779 —
G. Special Considerations—Branding Efforts and Nontraditional Articles ............................................ 781 10-10
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1. 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 10-105. 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 11-14
3. Issues to Consider in Crafting Protective Orders ................................................................ 819 11-15
B. Liability and Disqualification of Prosecuting- Litigators ................................................................... 825 11-171. Inequitable Conduct as a Conflict .................. 825 —2. Depositions of Prosecuting-Litigators ............. 826 11-17
C. Advocate-as-Witness Disqualification ..................... 828 11-19 IV. Combining Opinion and Trial Representations .......... 831 11-19
A. Advocate-as-Witness Disqualification ................. 831 —
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1. The Courts Split on Advocate-as-Witness Disqualification ................................................ 832 —
2. What to Do ....................................................... 834 —B. Enhanced Risk of Waiver of Work Product ........... 835 11-19C. What to Do ............................................................... 842 —
V. Conclusion ..................................................................... 843 11-20
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 —H. The Claims Should Preferably Include
Reference Numerals ............................................... 859 — IV. Unity of Invention ......................................................... 860 12-3
A. 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 —
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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 13-3B. Motions Practice . ..................................................... 888 13-3
1. Motions to Amend [New Topic] ...................... — 13-42. Motions to Exclude [New Topic] ..................... — 13-8
C. Discovery ................................................................... 890 13-91. Initial Disclosures .............................................. 890 13-92. Testimonial Discovery ....................................... 891 13-93. Documentary Discovery .................................... 892 13-10
D. Treatment of Confidential Information ................. 894 13-11
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E. Use of the Federal Rules of Evidence and Handling of Exhibits. ............................................... 895 13-11
F. Oral Argument ......................................................... 896 13-11G. Final Written Decision ............................................. 897 13-12H. Settlement ................................................................. 897 —I. Regulation of Conduct of Counsel and Parties
and Sanctions ........................................................... 898 13-13 III. Inter Partes Review ......................................................... 899 13-16
A. Standing and Other Limitations ............................. 900 13-161. Unavailability of Inter Partes Review While
Post-Grant Review is Available .......................... 901 —2. One-Year Bar ..................................................... 901 13-163. Declaratory Judgment of Invalidity ................. 902 13-174. Claim and Issue Preclusion .............................. 902 —5. Prior Art and Arguments Already
Considered By the PTO .................................... 903 13-176. Assignor Estoppel [New Topic] ....................... — 13-18
B. Preliminary Proceedings .......................................... 904 13-19C. Trial Proceedings. .................................................... 905 13-20D. Appeal ....................................................................... 908 —E. Impact on Litigation and Patent
Procurement Strategies ........................................... 909 13-22 IV. Post-Grant Review ........................................................... 911 13-24
A. Scope of Post-Grant Review ..................................... 912 13-24B. 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 13-25A. 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 —2. Early Litigation Over Scope of Section 18
Review ................................................................ 920 —B. Patents Subject to the Transitional Program for
Covered Business Method Patents .......................... 920 13-25C. Key Differences Between Covered Business
Method Patent Review and Post-Grant Review ....... 922 13-26 VI. Conclusion ..................................................................... 925 —
Appendix A .............................................................................. 927 —
Appendix B .............................................................................. 945 —
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Appendix C ............................................................................... 967 —
Table of Cases ........................................................................ 1027 TC-1
Index ........................................................................................ 1061 —