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 .
Status of Application/Amendments/Claims
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office Action.
Applicant’s response filed on 1/23/2026 have been considered. Claims 30, 34 and 36 are canceled. Claims 15, 19, 23 and 31 are amended.
Claims 15, 19-29, 31-33, 35 and 37 are the subject of the present Official Action.
Priority
Applicant’s claim for the benefit of a prior-filed application EP20382442.0 and 371 of PCT/EP2021/064060 filed on 5/26/2020 and 5/26/2021, respectively, under 35 U.S.C 119(e) or under 35 U.S.C 120, 121 or 365(c) is acknowledged.
Accordingly, the effective priority date of the instant application is granted as 5/26/2020.
Withdrawn Rejections
Nonstatutory Double Patenting
The provisional nonstatutory double patenting rejection of claims 15 and 20-27 has been withdrawn in light of applicants claim amendments describing the intramuscular administration of FGF21 to improve muscle function and/or strength in a subject, whereas the co-pending claims described administration into the CNS for treating obesity.
A response to Applicant’s arguments with regard to a withdrawn rejection is moot.
Claim Rejections - 35 USC § 102
The rejection of Claims 15 and 19-37 under 35 U.S.C. 102(a)(2) as being anticipated by Bosh et al. US 2020/0102361, published 4/2/2020, priority date 5/24/2017 (hereinafter Bosh) has been withdrawn.
A response to Applicant’s arguments with regard to a withdrawn rejection is moot.
New grounds of Rejections in response to Applicants’ amendments
New 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 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 15 and 19-37 are newly rejected under 35 U.S.C. 102(a)(2) as being anticipated by Bosh et al. US 2020/0102361, published 4/2/2020, priority date 5/24/2017 (hereinafter Bosh, reference of record) as evidenced by Dunham et al. "A note on a simple apparatus for detecting neurological deficit in rats and mice." (1957): 208-209 (hereinafter Dunham). This rejection is newly applied to address applicants claim amendments on 1/23/2026.
Claims 15, 32, 33 and 35: Bosh describes a viral expression construct comprising a nucleotide sequence encoding fibroblast growth factor 21 (FGF21) to be expressed in skeletal muscle tissue (Bosh, abstract). Bosh describes the intramuscular administration of said viral expression construct (Bosh, para 139). Bosh presents this as a method for extending the healthy lifespan of a subject by positively affecting numerous health indicators including metabolism, aging, antifibrosis, obesity, inflammation among many others (Bosh, para 120-136). In particular, Bosh states that extending lifespan reads on “improved coordination and balance” (Bosh, para 131). Bosh describes improved neuromuscular coordination and various techniques used for experimentally measuring improved coordination including the Rota-Rod test (Bosh, para 131). Dunham is provided as an evidentiary reference showing how the Rota-Rod test is performed, wherein mice are placed on a rotating rod that accelerates over time. The test records how long the animal can stay on the rotating rod without falling into a padded base, thus measuring “muscle function” and/or “muscle strength” (Dunham, Fig 1). Thus, Bosh describes improved muscle function through the intramuscular administration of a viral vector encoding FGF21.
Claims 19 and 37: Bosh describes methodologies for extending the healthy lifespan in mammals, particularly human beings (Bosh, para 1). Bosh provides preferred embodiments towards treating human beings from a variety of ages (Bosh, para 111).
Claims 20-22: Bosh describes preferred embodiments towards the use of a ubiquitous promoter including CAG and CMV (Bosh, para 35, 37).
Claims 23-24: Bosh discloses the delivery of a codon optimized human FGF21 encoded by the nucleotide sequence of SEQ ID NO: 5 which shares 100% sequence similarity to instant SEQ ID NO: 5 (sequence search results shown below).
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618
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Greyscale
Sequence search results of Seq ID NO: 5 aligned with instant Seq ID NO: 5
Claims 25-29: Bosh describes the use of a viral vector delivery system with preferred embodiments to AAV1, AAV8 and AAV9 serotypes which exhibit skeletal muscle tropism (Bosh, para 106, 228). Bosh describes the use of AAV ITRs (Bosh, para 228).
Claim 31: Bosh describes intramuscular injection of the gene therapy vector (Bosh, para 371, 400).
Conclusion
Claims 15, 19-29, 31-33, 35 and 37 are rejected.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 extension fee 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 Dr. ALEXANDER NICOL whose telephone number is (571)272-6383. The examiner can normally be reached on M-F 8-5 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Maria Leavitt can be reached on (571)272-1085. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Alexander Nicol
Patent Examiner
Art Unit 1633
/ALEXANDER W NICOL/Examiner, Art Unit 1634
/MARIA G LEAVITT/Supervisory Patent Examiner, Art Unit 1634
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