1. 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
11/14/2018

2. 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?
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3. 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.
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4. Issues Prior art Scope of Disease
Scope of therapeutic agent and its administration
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5. 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?
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6. 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.
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7. 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
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8. 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?
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9. 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?
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10. 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
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11. 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
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12. 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.
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13. 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
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14. 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
11/14/2018