DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Status of claims
Pending:
2-20
Cancelled:
1
New:
2-20
Examined:
2-20
Independent:
2
Priority
As detailed on the 08/31/2023 filing receipt, this application is a CON of 15/995,518 filed 06/01/2018 which is a CON of PCT/US16/64403 filed 12/01/2016 which claims benefit of U.S. Provisional Application No. 62/291,274 filed 02/04/2016 and claims benefit of U.S. Provisional Application No. 62/262,589 filed 12/03/2015.
U.S. Provisional Application No. 62/262,589 filed 12/03/2015 does not disclose single nucleotide polymorphisms rs2106124, rs1879796, rs12148845, rs12148100, rs17482885 and rs17629019 as recited in independent claim 2. Therefore, the earliest priority for this application is 02/04/2016.
Drawings
The drawings filed 08/15/2023 are accepted.
Information Disclosure Statement
The Information Disclosure Statements filed on 06/20/2025, 03/03/2025, 08/26/2024 (6), 06/17/2024, 03/19/2024, 01/11/2024, 11/21/2023 (2), 11/01/2023 (10) are in compliance with the provisions of 37 CFR 1.97 and have been considered in full. The Information Disclosure Statement filed on 12/12/2024 has been considered in part because reference #3 lacks appropriate dates and/or page numbers. A signed copy of list of references cited from the IDS is included with this Office Action.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 2-20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 2 recites “…about one year… an amount of about 2 mg quarterly after the about one year…” The phrase is unclear as it is not clear the metes and bounds of the term “about”. The term “about” in claim 2 is a relative term which renders the claim indefinite. The term “about” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. (see MPEP 2173.05(b))
Dependent claims are rejected for depending on rejected claims.
Regarding 35 USC 101
Claims 2-20 are patent-eligible under 35 U.S.C. 101 because independent claim 2 recites administering aflibercept to the patient in an amount of about 2 mg quarterly after the about one year previous treatment with the VEGF inhibitor when the patient has been determined to have one or more of the single nucleotide polymorphisms rs2106124, rs1879796, rs12148845, rs12148100, rs17482885 and rs17629019. The claims are implementing a judicial exception with or using a judicial exception to affect a particular treatment or prophylaxis for a disease or medical condition, as discussed in MPEP § 2106.04(d)(2). Therefore, the judicial exception is integrated into a practical application under Step 2A, 2nd prong of the 101 analysis.
Regarding 35 USC 102 or 35 USC 103
No prior art is applied to claims 2-20. Closest prior art reference is Hannum (US 2014/0336055 A1; published Nov. 13, 2014; cited on the attached 892 form). Hannum teaches genetic variations, such as single nucleotide polymorphisms associated with a vascular endothelial growth factor (VEGF) suppression response to an anti VEGF agent for treatment of a macular degeneration disorder. Hannum does not teach when the patient has been determined to have one or more of the single nucleotide polymorphisms rs2106124, rs1879796, rs12148845, rs12148100, rs17482885 and rs17629019 in independent claim 2. It is not clear that any combinable art of record would have rendered the claims obvious.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KETTIP KRIANGCHAIVECH whose telephone number is (571)272-1735. The examiner can normally be reached 8:30am-5:00pm EDT.
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/K.K./Examiner, Art Unit 1686
/Karlheinz R. Skowronek/Supervisory Patent Examiner, Art Unit 1687
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