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 .
Withdrawn rejections
Rejection of claims 1-11 under 35 USC 112(a) as not being enabled for antilipemic agents other than ezetimibe is withdrawn. Applicants have amended the claims to limit the antilipemic agent to ezetimibe.
Rejection of claims 1-4, 6, and 10-14 under 35 USC 112(a) as not being enabled for treatment of disorders other than retinal disorders that comprise mutation in RPE65 is withdrawn. Applicants have amended the claims to include limitation directed to RPE65 mutation.
Rejection of claims 15 under 35 USC 102(a)(1) over Cicero et al is withdrawn. Applicants have amended the claim to require a combination of agents which Cicero dos not disclose.
Maintained Rejections
Rejection of claims 1, 2, 5-8 and 10-11 under 35 USC 102(a)(1) over Cicero et al is maintained. The text of the rejection has been modified to reflect amendments made to the claims on 2/18/26, but the logic of the rejection remains the same. The rejection is maintained because applicants have limited the disorder being treated or prevented, however the subject population has not been limited. Since Cicero administers the claimed agent (ezetimibe) to the claimed subject population (subject) the limitations set forth in the rejected claims are met.
Claim Rejections - 35 USC § 102
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.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-8, and 10-11 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Cicero et al (Journal of Clinical Lipidology, 2020, 14, 646-648).
Cicero discloses administration of ezetimibe to a subject (page 647, last paragraph). The subject is disclosed as having a missense mutation (page 647, second to last paragraph). This disclosure anticipates herein rejected claims. The sole active step of the claims is administration of ezetimibe to a subject. By disclosing the sole active step of the claims, Cicero practices the following methods:
Preventing retinal degeneration that comprises mutation in RPE65
Treating a missense mutation disease that comprises mutation in RPE65
Decreasing FATP4 expression
Preventing loss of phototransduction that comprises mutation in RPE65
Increasing synthesis of 11-cis-retinal or 9-cis-retinal
Decreasing photoreceptor degeneration that comprises mutation in RPE65
Preserving visual cycle rate that comprise mutation in RPE65
New rejections
Claim Rejections - 35 USC § 103
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.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 15 and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jin et al (Adv. Exp. Med. Biol. 2016, 854, 525-532) In view of NICE (www.nice.org.uk/guidance/hst11, published 10/9/2019).
Scope of prior art
Jin suggests combination of 4-phenylbutyrate (PBA) and gene therapy for treatment of retinal degeneration due to RPE65 mutation (abstract).
Ascertaining the difference
Jin suggests combination of PBA and gene therapy, but fails to recite voretigene neparvovec as the gene therapy agent.
Secondary reference
NICE teaches voretigene neparvovec as a gene therapy agent for RPE65-mediated retinal dystrophies (page 30, “recommendations”)
Obviousness
A person of ordinary skill in the art would have found it obvious to combine PBA and gene therapy agent for treatment of RPE65-mediated retinal degeneration because Jin teaches the combination. A person of ordinary skill would have found it obvious to select voretigene neparvovec as the gene therapy agent to use in the method taught by Jin because NICE suggests it’s use for the same purpose as proposed by Jin. One would expect the combined composition would be effective at treating RPE65-mediated retinal degeneration.
Allowed claims
Claim 9 is allowed. Closest art is Cicero et al (Journal of Clinical Lipidology, 2020, 14, 646 648) who does not describe a subject population with RPE mutations.
Objected to claims
Claims 13 and 14 are objected as being dependent on a rejected claim. The claims require administration of 4-phenylbutyrate or a gene therapy agent together with ezetimibe. Closest art is Cicero, who does not suggest combination treatment with the claimed agents.
Conclusion
Claims 1-11, 13-15, and 19 are pending
Claim 9 is allowed
Claims 13 and 14 are objected to
Claims 1-8, 10-11, 15, and 19 are rejected
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to YEVGENY VALENROD whose telephone number is (571)272-9049. The examiner can normally be reached Mon-Fri 9am-5pm.
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/YEVGENY VALENROD/Primary Examiner, Art Unit 1628