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

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?

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.

Issues • Prior art • Scope of Disease • Scope of therapeutic agent and its administration

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?

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.

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

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?

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?

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

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

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.

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

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

Patentability Issues and Mechanism Claims