Patentability Issues and Mechanism Claims Biotechnology/Chemical/Pharmaceutical Customer Partnership Alexandria, Virgina April 29, 2004 Patentability Issues and Mechanism Claims Brian R. Stanton Quality Assurance Specialist Technology Center 1600 Brian.stanton@uspto.gov 571-272-0552 11/14/2018

Big Picture Claim is drawn to a method of inhibiting biologic process X. Why would one desire to inhibit such a process? Is it purely of scientific interest, or Is it potentially correlated with some disease state(s)? Has it been demonstrated to correlate with some biologically significant process? 11/14/2018

Claim: A method of treating a disease characterized by abnormal Protein X expression comprising administering to a mammal in need thereof, a therapeutically effective amount of an inhibitor of protein X. 11/14/2018

Issues Prior art Scope of Disease Scope of therapeutic agent and its administration 11/14/2018

Prior Art Question How does the mechanism of action distinguish that which is claimed from the prior art? Can the claim be drafted to include a process step that would not have been anticipated or obvious in view of the prior art? 11/14/2018

Prior Art Example Claim: A method of treating a disease characterized by increased intracranial pressure by administering acetominophen. Prior art: Treatment of hydrocephaly with tylenolTM. Rejection: Claim is anticipated by prior art even though mechanism is not disclosed. Hydrocephaly was discovered by applicant to be associated with increased intracranial pressure. 11/14/2018

Potential Prior Art Solution Compare/contrast: 1. A method of lowering the risk of heart attack comprising administering aspirin. Anticipated by methods of treating, e.g., headaches 2. A method of lowering the risk of heart attack by administering 84mg of aspirin once daily for 10 years. Different dose/timing 11/14/2018

Questions: Disease What conditions/diseases are characterized by abnormal Protein X expression? Are they known in the art? What is disclosed in specification? What is the relationship of the disease(s) to protein X expression? Correlative? Causal? 11/14/2018

Disease Scope Claim: A method of treating arthritis by administering a therapeutically effective amount of a protein X antagonist to a patient in need thereof. Is disease terminology too generic? e.g. Increased protein X is shown to be causative of rheumatoid arthritis Claim is to treating arthritis generically. Since “arthritis” is a generic term encompassing a variety of inflammatory disorders with different etiologies (e.g. osteoarthritis), would one reasonably expect that a single compound would treat the entire genus? 11/14/2018

Questions: Agent What is the state of the art regarding protein X inhibitors? How does one use/administer different types of inhibitors? Small organics Antibodies Soluble receptor Antisense Peptide antagonist 11/14/2018

Written Description Questions 35 U.S.C. §112, first paragraph, Written Description What diseases are associated with mechanism? What inhibitors are known? Assays are not a substitute for structural information 11/14/2018

Enablement Questions 35 U.S.C. §112, first paragraph, enablement Would it require undue experimentation to determine what diseases are associated with mechanism? Would it require undue experimentation to determine how to administer an effective amount? Dosage, formulation, timing, mode… What guidance is there for how to make the inhibitors? Assay is not sufficient in and of itself without some guidance as to how to make. 11/14/2018

Potential Solution to 35 USC 112, issues Recite specific disorder(s) in claim Recite specific compound(s) in claim Recite specific dosage/adminstration regimens in claim(s) Consider filing a continuing application claiming a different invention drawn to Method of diagnosis Method of screening for effective agents 11/14/2018

Thank You Brian R. Stanton Quality Assurance Specialist Biotechnology/Chemical/Pharmaceutical Customer Partnership Alexandria, Virgina April 29, 2004 Thank You Brian R. Stanton Quality Assurance Specialist Technology Center 1600 Brian.stanton@uspto.gov 571-272-0552 11/14/2018