- What are ways to avoid/ overcome obviousness-type double patenting (ODP) rejections?
- In the US, ODP can arise in “related” continuation applications or applications that do not share priority (requires at least one common inventor, but can have different assignees)
- Three ways to overcome ODP rejection:
- Safe Harbor protection under §121 (only for divisional applications)
- On the merits (claims are nonobvious)
- File a terminal disclaimer (TD), which requires common ownership for duration of patent term
- Pre-filing/drafting considerations:
- Know scope of already claimed subject matter (including dependent claims)
- Distinguish improvements or selections from prior filings during preparation of new unrelated applications (e.g., unexpected properties of or results produced by a species)
- Draft and pay for diverse claim set (likely to prompt a restriction requirement)
- If you think you might need a TD, maintain common-ownership
- Prosecution strategies:
- Do not assume Examiner’s ODP rejection is proper
- Same non-obviousness rebuttals as you would use for §103, including secondary considerations
- Carefully consider risk to patent term before filing TD (and must remain co-owned)
- If patent issues with large PTA, consider risk of continuation application (Gilead)
- How do you leverage fast-track examination tools to streamline global prosecution?
- Goal is reduction in overall cost and efficiency of building patent portfolio
- Track One Prioritized Examination
- $4k/$2k USD; no more than 4 independent claims and 30 total claims
- Months to First Office Action: Track One – 1.8; Traditional – 15.7
- Months to Final Disposition: Track One – 7.2; Traditional – 24.3
- Patents 4 Patients (fast-track review for cancer immunotherapy-related applications without fee)
- Patent Prosecution Highway
- Accelerate prosecution in related second application based on an allowed first application in another country
- Applications must share a common priority date; claims must “sufficiently correspond” to the allowed claims
- Higher allowance rate compared to non-PPH cases; shorter pendency; fewer Office Actions
- Combine tools to quickly generate global portfolio (Track One; PACE; PPH; PPH-PCT)
- What prosecution strategies are life sciences companies implementing to create IPR and PGR resilient patents?
- Seeking high quality patents: goal is non-institution
- 7,704 IPR Petitions: 68% institution rate; 76% of claims canceled at FWD; 10% in bio/pharma
- 110 PGR Petitions: 58% institution rate; 85% of claims canceled at FWD; 27% in bio/pharma
- Pre-filing: robust patentability searching
- Know best art before competitors; objective assessment of patentability
- Help distinguish invention from prior art during preparation; better define claim scope
- Application drafting considerations:
- Compelling patentability story in the face of most pertinent prior art (problem/solution)
- Provide clear definitions for claim terms (glossary)
- Numerous claims of varying scope and format that are clearly supported by the specification ($15,500 IPR fee up to 20 claims; $300 each additional claim)
- Prosecution strategies:
- Get key art on the record and considered by the Examiner during prosecution
- Well drafted declarations addressing art, claim construction and/or secondary considerations (evidence must be commensurate in scope with claims)
- Create patent thicket to extent possible around product including separate patents only including claims specifically directed to approved product
- Expedited prosecution (e.g., Track One) and judicious use of reissue applications to gain additional patents prior to patent owner estoppel; keep pending continuation
- How do you navigate the narrowing subject matter eligibility threshold in the life sciences?
- In the US, product and process claims can be found patent ineligible if directed to laws of nature or natural phenomenon (product and diagnostic claims are more frequently at risk)
- While addressing different subject matter (diagnostic drug correlations, isolated genes, and algorithms), each of Mayo/Myriad/Alice aimed to exclude tools of research from eligibility
- Considerations for drafting patent eligible products and/or process claims:
- Include characteristics distinct from the natural counterpart (not just isolated or purified)
- Add significantly more than what is found in nature (structure and/or functional differences)
- Once natural phenomenon is removed from the claims, the remaining elements cannot be merely routine, conventional, and well-understood components or steps
- If all elements of the claim were well known and in common use, consider whether the combination of these elements is inventive
- Use of diagnostics and/or products in methods of treatment
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