Chemical Patent Practice Course Syllabus I. INTRODUCTION TO CHEMICAL PATENT PRACTICE: SETTING THE STAGE FOR DISCUSSING STRATEGIES FOR REDUCING RISK OF UNENFORCEABILITY AND ENHANCING CHANCES OF INFRINGEMENT, PATENTABILITY, AND VALIDITY II. DRAFTING CHEMICAL CLAIMS AND SPECIFICATION A. Disclosure of the Invention B. Guidelines for Preparing Disclosure to Set the Stage for Claims 1. Define and consistently use terms 2. More may be better to provide written description support and enablement 3. Use patent profanity judiciously 4. Focus on claims that will be literally infringed and yet are still patentable before both the USPTO examining corps and PTAB and valid in district courts and the ITC C. Claiming the Chemical Invention 1. Determine how the invention differs from prior art and the probable scope of the invention 2. A complete understanding of the invention and the prior art will aid in determining how best to claim it in view of the objectives of patentability, validity, and infringement 3. Make sure the claim describes the invention, being neither overly narrow nor overly broad! 4. Take into account enablement and written description (particularly possession in drafting claims) 5. Consider induced infringement particularly in Orange Book-listed patents in the pharmaceutical arts D. Parts of the Claim 1. The Preamble 2. Transition Terms Comprising, Consisting of, Consisting Essentially of 3. Whereby 4. Jepson Claims 5. Drafting Process Claims in View of 35 U.S.C. 271(g) 6. Means plus function claims in view of 35 U.S.C. 112(f) 7. What About Metabolites? E. Specific Claiming Suggestions 1
F. Recent PTAB cases highlight the difficulty of challenging patents using arguments that were considered when the patent was examined, and may aid patent owners in getting inter partes review petitions denied II. CLAIM CONSTRUCTION: THINK IT THROUGH DURING INITIAL DRAFTING AND CERTAINLY IN PROSECUTION TO GIVE PATENTEE BASIS FOR DESIRABLE CLAIM CONSTRUCTION BEFORE PTAB, DISTRICT COURTS, AND THE ITC A. Different standards during litigation, PTAB, and prosecution (proposed rule issued May 9, 2018 to make claim construction the same at PTAB and in litigation) B. Practical considerations 1. Ordinary meaning of claim 2. Construing the preamble 3. Construing transition terms comprising, consisting of, consisting essentially of C. Doctrine of Equivalents 1. Prosecution history estoppel: presumption of surrender 2. All elements rule 3. Insubstantial differences 4. Narrow claim language 5. Prior art as a limitation on equivalents 6. Disclosed but unclaimed subject matter D. Prosecution History Estoppel 1. When does prosecution history estoppel arise? 2. The significant distinction between prosecution history in claim interpretation and in the doctrine of equivalents 3. Effect of prosecution history on claim interpretation 4. Effect of prosecution history estoppel on scope of equivalents under the doctrine of equivalents E. Acts That Give Rise to Prosecution History Estoppel 1. Classical prosecution history estoppel: amendments in response to prior art rejections 2. Estoppel by admission: arguments made to examiners without amendment 3. Amendments in response to non-art rejections 4. Remarks made after allowance 5. Multiple arguments to overcome prior art may or may not create multiple separate estoppels 6. Failure to continue prosecution 7. Representations to foreign patent offices? 8. Examiner estoppel? 2
F. Effect of Estoppel 1. Effect of estoppel on other claims in same patent 2. Effect of estoppel on related applications 3. Effect of estoppel on same claims G. Specific Suggestions to Avoid and/or Minimize Chances of Prosecution History Estoppel IV. 35 U.S.C. 112 A. The Second Paragraph, now called (b) under AIA 1. General Considerations 2. The Precision and Definiteness Requirement a. Supreme Court s Decision in Nautilus v. Biosig and Federal Circuit on Remand b. Understood By One of Ordinary Skill in the Art c. Must be Able to Tell Who Would Infringe and How d. Words of Degree e. Too Many Possible Definitions = Indefinite f. Lack of Antecedent Support Not Necessarily Indefinite g. Breadth is Not Automatically Indefiniteness h. Summary 3. Defining What the Applicant Regards as the Invention B. The First Paragraph (now called (a) under AIA) to Support the Claims 1. General Considerations 2. The Written Description Requirement a. General Considerations b. Development of Requirement c. Written Description Guidelines and particularly the concept of possession d. Proving Written Description Support i. General Considerations ii. Use of Knowledge of Those Skilled in the Art iii. Support for Broad Claims iv. Support for Narrowed Claims v. Using CCPA 112 cases to help you e. Lack of Written Description Support f. Reissue for Invention Unclaimed in Original Application i. Broadening and Attendant Issues ii. Narrowing and Attendant Issues iii. Reissue recapture g. Clarifying the Written Description as Understood by the POSITA as to What the Inventors Reasonably Convey (During Prosecution Also?) i. Expert Testimony ii. Inherency: Chen v. Bouchard h. New Matter: an Issue of Written Description i. Biological Deposits 3. The Enablement Requirement a. Some Essentials i. Core Requirements 3
ii. No Need for Production Blueprint b. Procedural Aspects of the Enablement Inquiry i. Shifting Burdens ii. Enablement is Judged as of an Applications Filing Date iii. Enablement is a Question of Law c. Mechanics of the How to Make and the How to Use Requirements d. Supplementing the Written Description (During Prosecution Also?) i. Expert Testimony ii. Inherency C. The Fourth Paragraph, now called (d) under AIA D. The Sixth Paragraph ( 112(f)): Means plus function E. 112 Issues in chemical AIA post-grant proceedings V. 112: BEST MODE IS STILL A STATUTORY REQUIREMENT OF 112 A. Comment on Best Mode Post-AIA: Continue to Satisfy this Statutory Requirement B. Purpose of the Best Mode Requirement C. Best Mode Distinguished From Enablement D. Determining a Best Mode Violation 1. Legal Standard 2. Relevant Time for Disclosing the Best Mode 3. Subjective Knowledge of the Best Mode a. Contemplation of a Best Mode b. No Imputed Knowledge Within a Corporation c. Claim Scope Limitations to the Best Mode Inquiry d. Specificity of Disclosure to Those Skilled in the Art e. Best Mode Indiscriminately Disclosed f. Trade Secrets of Others Used in the Best Mode 4. Deposit of Biological Materials E. Effect of a Best Mode Violation 1. Proceedings initiated before AIA 2. Proceedings initiated after AIA VI. INEQUITABLE CONDUCT AND UNCLEAN HANDS: DO NOT MISTAKENLY THINK THAT THERASENSE MOOTED THESE ISSUES A. Inequitable Conduct Doctrine Before Therasense 1. Intent: The Inconsistent Precedent 2. Materiality: Multiple Standards 3. Review of Case Law Leading Up to Therasense and Cases Cited by The Supreme Court in Therasense 4
B. Therasense: Federal Circuit En Banc C. Post-Therasense 1. Post-Therasense Federal Circuit Decisions 2. Post-Therasense District Court Decisions 3. How Will Practitioners Respond in Prosecution? 4. What is the role of Supplemental Examination? 5. What is the effect of AIA s derivation proceedings on inequitable conduct? D. USPTO s Proposed Revision to Rule 56 E. Unclean Hands Federal Circuit Decisions: the Revival in Gilead v. Merck of the Supreme Court Trilogy in the 1930 s and 1940 s 1. Differences from inequitable conduct. 2. What is the role of Supplemental Examination? 3. What is the effect of AIA s derivation proceedings on inequitable conduct? VII. 35 U.S.C. 102 A. Pre-AIA Section 102: Defining What Constitutes Prior Art and Determining Novelty until at Least 2034 1. Pre-AIA 35 U.S.C. 102 2. Pre-AIA 35 U.S.C. 102 What Constitutes Prior Art a. 35 U.S.C. 102(a): Acts or Works of Those Other Than the Applicant b. 35 U.S.C. 102(b): The Statutory Bar Provision i. Patents and Printed Publications ii. Public Use iii. On-Sale Activity iv. The Test v. Inherent Qualities vi. Printed Publications in IPRs, particularly with respect to non-patent literature (NPL) c. 35 U.S.C. 102(c): Abandonment d. 35 U.S.C. 102(d): Foreign Patenting e. 35 U.S.C. 102(e): Prior Art of Another f. 35 U.S.C. 102(f): Derivation g. 35 U.S.C. 102(g): Prior Invention of Another 3. What Constitutes Anticipation? a. Generally b. Reference Must Be Enabled c. Using Extrinsic Evidence/Multiple References d. Compounds and Compositions e. Genus-Species f. No Teaching Away g. Anticipating Range Limitations i. Prior Art Teaches Species Falling Within the Claimed Range 5
ii. Prior Art Teaches a Range Overlapping the Claimed Range iii. Prior Art Teaches a Range Falling Within the Claimed Range vi. Prior Art Teaches a Range Sharing an Endpoint With the Claimed Range h. Inherency B. AIA 35 U.S.C. 102 1. Definitions of Prior Art in AIA 102(a)(1) and (a)(2) 2. Statutory Exceptions in AIA 102(b)(1) and (b)(2), Including Expansion of The CREATE Act and Common Ownership as Exceptions 3. Transition Provisions AIA Sections 3(n)(1) and 3(n)(2) 4. Case law developing on AIA 102 2. Prior Commercial Use VIII. 35 U.S.C. 103 A. The Factual Inquiries and Indicia of Graham 1. Scope and Content of Prior Art a. Analogous Art Requirements b. A Reference Must Enable What It Discloses c. Admissions of Prior Art 2. The Differences Between the Prior Art and the Claimed Invention a. Consideration of the Prior Art in Its Entirety b. Consideration of the Claimed Invention as a Whole i. The Properties and Advantages of the Invention Are Part of the Invention as a Whole ii. Functional Language in a Claim Must Not Be Ignored iii. The Preamble as a Limitation 3. The Level of Ordinary Skill in the Art 4. Objective Indicia of Nonobviousness, including balancing the prima facie case with the objective evidence B. The Prima Facie Case of Obviousness: A Procedural Tool of Examination But Also Appears Highly Relevant in PTAB Institution/Denial of IPR/PGR Petitions C. Responding to an Alleged Prima Facie Case by Attacking Its Premise 1. Prima Facie Obviousness in Chemical Cases 2. The Requisite Motivation Supporting the Modification a. The Prior Art Must Provide a Basis For the Modification b. Conclusion of Obviousness Cannot Derive From Applicants Specification c. Basis in the Art Need Not Be Explicit and Can Be Implied d. Inherency of a Claimed Element or Advantage of the Invention Is Immaterial e. Reason for Combining and Modifying Prior Art Can Differ From That Relied on by Applicant 6
f. Recognition of Problem Different From Recognition of Solution g. Prior Art Teaches Away h. Asserted Prior Art References Need Not Show That Claimed Combination is Preferred Alternative i. No Obviousness Where Proposed Modification Would Destroy Intended Function of Reference j. Conflict in Teachings of the Prior Art References k. Prior Art and Claimed Invention Do Not Share the Same Utility 3. The Prior Art Must Provide a Reasonable Expectation That the Proposed Modification Will Succeed a. Obvious to Try b. Nonrecognition of Result-Effective Variable c. Evidence Showing a Lack of Expectation of Success 4. Chemical Compounds: The Issue of Structural Similarity a. Thwarting the Presumption i. Showing the Unexpected ii. The Prior Art Must Disclose a Method of Making a Structurally Similar Compound b. Homologs i. N-methyl Derivatives ii. Methyl Substituted Aromatics iii. Aromatics iv. Alkylene Homologs c. Isomers i. Aliphatics ii. Aromatic Substitution iii. Esters iv. Optical Isomers d. Analogs i. Esters ii. Substitution of Hydrogen for Hydroxy of Ethenyl For Ethyl iii. Halogen Substitutes iv. Substitution of Sulfur For Oxygen v. Substitutions of Ring Systems vi. Substitutions on Ring Systems e. Isosterism f. Patentability of a Species Within a Genus g. Prior Art Intermediates h. Purer Forms of Old Compounds 5. Compositions and Formulations a. Claimed Compounds Plus a Carrier b. Patentability of Ranges c. Combining Equivalents Known For the Same Purpose d. Substituting Equivalents Known For the Same Purpose 6. Method of Use Claims 7. Product-by-Process Claims 8. Methods of Making Claims a. Patentability of Otherwise Routine Processes Using Patentable Starting Materials or Final Products b. Sequence of Steps c. Temperature and Concentration Limitations 7
d. Making the Process Continuous e. Producing Expected or Unexpected Results From the Process D. Rule 132 Affidavits E. Proof of Unobviousness 1. Unexpected Results a. Compare to Closest Prior Art and/or to the Lead Compound? b. Need Not Be Art Relied Upon by Examiner c. What if Closest Art Not Available? d. Closest Embodiment Within Closest Prior Art e. Maintain Comparison f. Closest Prior Art Need Not Be Commercial Standard g. Indirect Comparisons h. Nexus to Claimed Invention 2. Commensurate in Scope With the Claims, as defined in CCPA Hollingsworth 3. Other Objective Indicia of Nonobviousness a. Commercial Success b. Long-Felt Need c. Failure By Others d. Copying e. Teaching Away f. Initial Disbelief/Skepticism g. Subsequent Acclaim by Experts h. Nexus to Claimed Invention 4. Considerations Prosecution Declarations in Context of Shoring Up Claims to Survive IPR IX. DOUBLE PATENTING A. Introduction 1. Statutory Double Patenting: Same Invention Type 2. Nonstatutory Double Patenting: Obviousness Type B. 35 U.S.C. 121 and Double Patenting C. 35 U.S.C. 303 and Double Patenting D. Comparison of Earlier-Filed to Later-Filed E. Recent Chemical Double-Patenting Cases F. PTA and ODP and Common Ownership? X. PATENT TERM ADJUSTMENT/PATENT TERM EXTENSION XI. CHEMICAL PATENT CASE STUDIES 8
A. Using the Prosecution History of the Cited Prior Art to Rebut Motivation to Combine References B. Use of Prior Art Reference, an Interview, and the Statement of Reasons for Allowance to Attack Prima Facie Case of Obviousness C. Establishing Knowledge of Those Skilled in the Art by a Declaration From the Author of the Prior Art D. Showing Deficiency in Prior Art References 9