Biotechnology USPTO Eligibility Guidance - Examples
Subject Matter Eligibility Guidance
The USPTO Subject Matter Eligibility Guidance includes hypothetical examples where the 2 step subject matter eligibility analysis is applied. These examples are not law and the USPTO warns applicants against using them as templates. That being said, the USPTO considers the examples a teaching tool for both patent examiners and the public. At the risk of oversimplification, there are 4 possible findings that lead to an eligible determination after passing Step 1. Selected claims from Subject Matter Life Science Examples; Vaccines #28 and Diagnosing and Treating Julitis #29, are used here for illustration.
After passing Step 1, by determining the invention is a process or composition of matter, subject matter eligible may be determined by way of 4 possible findings.
1. The claim is directed to a process or composition of matter not found in nature - (step 2A -not an exception) - eligible.
Composition of matter example: Vaccine. A claim is directed to an vaccine comprising inactivated Pigeon flu virus. The virus is chemically inactivated for reduced virulence. Not found in nature. The claim is eligible.
Process example: Diagnoses. A claim is directed to a method of detecting JUL-1 (disease marker) in a patient, by removing a plasma sample and detecting JUL-1 in the sample using mAb-D33, a specific (porcine) antibody, not routinely used at the time. This process does not occur in nature. The claim is eligible.
2. The claim is directed to a process or composition of matter found in nature - (step 2A - an exception) - ineligible
Composition of matter example: A claim is directed to a vaccine compromised of Peptide F and a pharmaceutical carrier. The broadest interpretation of this claim would include a composition of Peptide F and water. Peptide F and water are both found in nature but not together. Are new properties formed by a composition of Peptide F and water? No. Does the claim contain significantly more? No. The claim is not eligible.
Process example: Diagnoses. A claim is directed to diagnosing julitis in a patient based on detecting JUL-1 in the patient's serum using (any) anti-JUL-1 antibodies. The technical steps are not new or limiting. The claim is directed to the observation of JUL-1 which is a natural phenomenon. Does the claim contain significantly more? No. The claim is not eligible.
3. The claim is directed to a process or composition of matter found in nature, but claimed in a state that conveys new properties - (step 2A -not an exception) - eligible
4. The claim is directed to a process or composition of matter found in nature, but includes significantly more. Significantly more might be a significant limitation and/or including something that was not routine at time of the invention - (step 2A - an exception, but eligible under step 2B) -eligibleComposition of matter example: A claim directed to a vaccine comprising Peptide F and an immuno-effective amount of an aluminium salt adjuvant. Peptide F and aluminium salt are found in nature but the combination is not. The composition conveys new properties, that being increased immunogenicity. The claim is eligible.
Process example: Treatment. A claim is directed to a method of treating a patient with julitis by administering anti-TNF antibodies to a patient suffering from julitis. The process as a whole is not found in nature. The claim is eligible.
Composition of matter example: A claim is directed to a vaccine delivery device of a microneedle array coated with Peptide F. Peptide F is found in nature but not coated on microneedles. The composition does not convey new properties. Does the claim include Significantly more? Yes. Microneedles were known but not routinely used at the time and Peptide F is confined to a particular use. The claim in eligible.
Process example: Diagnosis/Treatment. A claim is directed to a method of diagnosing and treating julitis by detecting JUL-1 in the patient's plasma and treating the patient by administering vitamin D. Is the process found in nature? Yes, it is an observation of a natural phenomenon. Is there significantly more? Yes. Treatment with vitamin D was unconventional at the time.
