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 .
Application Status
The Amendments and Remarks filed 09 December 2025 are acknowledged and have been entered. Claims 19, 22, 27 and 30 have been amended. Claims 1-18, 20-21, 23-24, 26 and 28-29 have been cancelled. Claims 33-39 are newly added. Claims 19, 22, 25, 27, and 30-39 are pending and being examined on the merits.
Any objection or rejection not reiterated herein has been overcome by applicant’s claim amendments.
Priority
This application is a 371 PCT of CN2021/098217 filed 06/04/2021. Acknowledgment is made of applicant's claim for foreign priority based on an application filed in China on 09/29/2020. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Should applicant desire to obtain the benefit of foreign priority under 35 U.S.C. 119(a)-(d) prior to declaration of an interference, a certified English translation of the foreign application must be submitted in reply to this action. 37 CFR 41.154(b) and 41.202(e).
Failure to provide a certified translation may result in no benefit being accorded for the non-English application.
Response to Arguments
Applicants argue that the certified English-language translation of the priority application (specifically CN202011048122.X) being filed herewith is sufficient for the pending Application to be afforded the benefit of foreign priority under 35 U.S.C. § 119(a)-(d) pursuant to 37 C.F.R. §§ 41.154(b) and 41.202(e). Applicant’s arguments filed 12/09/2025 have been considered and are found unpersuasive as the certified English-language translation of the priority application has not been filed.
Drawings
In addition to Replacement Sheets containing the corrected drawing figure(s), applicant is required to submit a marked-up copy of each Replacement Sheet including annotations indicating the changes made to the previous version. The marked-up copy must be clearly labeled as “Annotated Sheets” and must be presented in the amendment or remarks section that explains the change(s) to the drawings. See 37 CFR 1.121(d)(1). Failure to timely submit the proposed drawing and marked-up copy will result in the abandonment of the application.
Nucleotide and/or Amino Acid Sequence Disclosures
REQUIREMENTS FOR PATENT APPLICATIONS CONTAINING NUCLEOTIDE AND/OR AMINO ACID SEQUENCE DISCLOSURES
Items 1) and 2) provide general guidance related to requirements for sequence disclosures.
37 CFR 1.821(c) requires that patent applications which contain disclosures of nucleotide and/or amino acid sequences that fall within the definitions of 37 CFR 1.821(a) must contain a "Sequence Listing," as a separate part of the disclosure, which presents the nucleotide and/or amino acid sequences and associated information using the symbols and format in accordance with the requirements of 37 CFR 1.821 - 1.825. This "Sequence Listing" part of the disclosure may be submitted:
In accordance with 37 CFR 1.821(c)(1) via the USPTO patent electronic filing system (see Section I.1 of the Legal Framework for Patent Electronic System (https://www.uspto.gov/PatentLegalFramework), hereinafter "Legal Framework") as an ASCII text file, together with an incorporation-by-reference of the material in the ASCII text file in a separate paragraph of the specification as required by 37 CFR 1.823(b)(1) identifying:
the name of the ASCII text file;
ii) the date of creation; and
iii) the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(1) on read-only optical disc(s) as permitted by 37 CFR 1.52(e)(1)(ii), labeled according to 37 CFR 1.52(e)(5), with an incorporation-by-reference of the material in the ASCII text file according to 37 CFR 1.52(e)(8) and 37 CFR 1.823(b)(1) in a separate paragraph of the specification identifying:
the name of the ASCII text file;
the date of creation; and
the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(2) via the USPTO patent electronic filing system as a PDF file (not recommended); or
In accordance with 37 CFR 1.821(c)(3) on physical sheets of paper (not recommended).
When a “Sequence Listing” has been submitted as a PDF file as in 1(c) above (37 CFR 1.821(c)(2)) or on physical sheets of paper as in 1(d) above (37 CFR 1.821(c)(3)), 37 CFR 1.821(e)(1) requires a computer readable form (CRF) of the “Sequence Listing” in accordance with the requirements of 37 CFR 1.824.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed via the USPTO patent electronic filing system as a PDF, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the PDF copy and the CRF copy (the ASCII text file copy) are identical.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed on paper or read-only optical disc, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the paper or read-only optical disc copy and the CRF are identical.
Specific deficiencies and the required response to this Office Action are as follows:
Specific deficiency – Nucleotide and/or amino acid sequences appearing in the specification are not identified by sequence identifiers in accordance with 37 CFR 1.821(d).
Required response – Applicant must provide:
A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3) and 1.125 inserting the required sequence identifiers, consisting of:
A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
A copy of the amended specification without markings (clean version); and
A statement that the substitute specification contains no new matter.
Specification
The substitute specification filed 12/29/2025 has not been entered because it does not conform to 37 CFR 1.125(b) and (c) because: a marked-up copy of the substitute specification has not been supplied (in addition to the clean copy). Of note, the newly filed specification no longer contains the priority or incorporation by reference paragraphs.
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 34 and 39 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.
Claims 34 and 39 recite “the sgRNA comprises: primer pair 1 and primer pair 2, wherein primer pair 1 is shown in SEQ ID NO: 1 and SEQ ID NO: 2, and primer pair 2 is shown in SEQ ID NO: 3 and SEQ ID NO: 4”. A sgRNA does not comprise a primer pair. An sgRNA is a functional RNA molecule used to guide a nuclease (like Cas9) to a specific DNA sequence for gene editing. In contrast, a primer pair consists of two short DNA strands used to amplify a target DNA sequence during processes like PCR. Therefore, it is unclear what is meant for a sgRNA to comprise a primer pair.
Claims 34 and 39 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. This is a new matter rejection.
MPEP 2163.I1.A.3.(b) states, "when filing an amendment an applicant should show support in the original disclosure for new or amended claims" and "[i]f the originally filed disclosure does not provide support for each claim limitation, or if an element which applicant describes as essential or critical is not claimed, a new or amended claim must be rejected under 35 U.S.C. 112a, as lacking adequate written description". According to MPEP § 2163.1.B, "While there is no in haec verba requirement, newly added claim limitations must be supported in the specification through express, implicit, or inherent disclosure" and "The fundamental factual inquiry is whether the specification conveys with reasonable clarity to those skilled in the art that, as of the filing date sought, applicant was in possession of the invention as now claimed. See, e.g., Vas-Cath, Inc., 935 F.2d at 1563-64, 19 USPQ2d at 1117".
The claims recite “the sgRNA comprises: primer pair 1 and primer pair 2, wherein primer pair 1 is shown in SEQ ID NO: 1 and SEQ ID NO: 2, and primer pair 2 is shown in SEQ ID NO: 3 and SEQ ID NO: 4”. A sgRNA does not comprise a primer pair. An sgRNA is a functional RNA molecule used to guide a nuclease (like Cas9) to a specific DNA sequence for gene editing. In contrast, a primer pair consists of two short DNA strands used to amplify a target DNA sequence during processes like PCR. The specification teaches that ‘an sgRNA sequence of knockdown KAT7 gene was obtained from a GeCKOv2.0 (1000000048) plasmid library’ (pg. 8-9). The specification also teaches primers for detecting the mRNA levels (pg. 11). However, the specification does not adequately describe a sgRNA comprising a primer pair.
Taken together, the specification or the art does not provide sufficient written description for the claims, as currently recited. Since no basis has been identified, the claims are rejected as incorporating new matter.
Claim Rejections - 35 USC § 102
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.
Claims 19, 22, 25, 27, 33, and 35-37 are rejected under 35 U.S.C. 102(a)(1)as being anticipated by Wang (Wang et al. J. Biol. Chem. (2019) 294(25) 9734–9745).
Claims 19, 22, and 33 recites a method of preparing a product for treating and/or preventing senescence and for inhibiting hepatic fibrosis; wherein, the method comprises the following steps: (a) providing a substance that reduces the content or activity of KAT7, or a substance that inhibits KAT7 gene expressions or knocks down KAT7 genes, or knocks out KAT7 genes; (b) formulating the substance into a pharmaceutically acceptable product for treating and/or preventing the senescence or inhibiting the hepatic fibrosis; and wherein the substance is a CRISPR/Cas9 gene knockout system targeting KAT7 genes or WM3835. The recitation ‘for treating and/or preventing senescence and for (the) inhibiting hepatic fibrosis’ is a functional limitation of the product and does not limit the method by which the product is made. Wang teaches formulating a CRISPR Cas system comprising a Cas9 and sgRNAs targeting KAT7 in lentiviruses (i.e., recombinant vector) for KAT7 knock out in nasopharyngeal carcinoma cells [abstract; pg. 9735, col. 1, para 4 – col. 2].
Regarding claim 25 and 35-37, a limitation of the senescence or the hepatic fibrosis does not limit the claimed method and does not distinguish the production of the product as claimed from the product as disclosed by Wang as applied to claim 19.
Regarding claim 27, the claims are directed to a product for treating and/ or preventing senescence or a product for inhibiting hepatic fibrosis. Since the therapeutic use does not materially affect the chemical composition or structure of the product, it does not have a limiting effect. The teachings of Wang are discussed above as applied to claim 19.
Claim Rejections - 35 USC § 103
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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.
Claims 19, 22, 25, 27, 30-33 and 35-38 are rejected under 35 U.S.C. 103 as being unpatentable over Yu (Yu et al. Int. J. Biol. Sci. 2020, Vol. 16) in view of Macip (Macip et al. The EMBO Journal. Vol. 21 No. 9 pg. 2180-2188. 2002) and Wang (Wang et al. J. Biol. Chem. (2019) 294(25) 9734–9745).
Regarding claim 30-32 and 38, Yu teaches a method of knocking down the expression of KAT7 using LV-shKAT7 in human renal tissue [pg. 2349, col. 2, para 3]. Yu teaches that KAT7 increases KLF6 acetylation and thereby initiating KLF6’s activation effect; and that knockdown of KAT7 reduced KLF6 acetylation [pg. 2354, col. 1]. Yu teaches that KLF6 activates p21 [pg. 2350, col. 2, para 3], thereby a reduction in KLF6 activation inhibits p21 activation.
Yu does not teach a method for delaying and/or treating and/or preventing senescence by administering a substance that inhibits KAT7 expression. Yu does not teach a CRISPR/Cas9 gene knockout system targeting KAT7 genes comprising a guide RNA (gRNA) specifically recognizing KAT7 gene and a Cas9 protein.
Macip teaches that p21 mediates senescence and that inhibition of p21 inhibits senescence [abstract; title; pg. 2180, col. 2, para 3].
Regarding claims, 19, 22, and 33, Wang teaches formulating a CRISPR Cas system comprising a Cas9 and sgRNAs targeting KAT7 in lentiviruses (i.e., recombinant vector) for KAT7 knock out in nasopharyngeal carcinoma cells [abstract; pg. 9735, col. 1, para 4 – col. 2]. Thereby Wang teaches an alternative way of inhibiting KAT7 expression.
Regarding claim 25 and 35-37, a limitation of the senescence or the hepatic fibrosis does not limit the claimed method and does not distinguish the production of the product as claimed from the product as disclosed by Wang as applied to claim 19.
Regarding claim 27, the claims are directed to a product for treating and/ or preventing senescence or a product for inhibiting hepatic fibrosis. Since the therapeutic use does not materially affect the chemical composition or structure of the product, it does not have a limiting effect. The teachings of Wang are discussed above as applied to claim 19.
It would have been obvious to one ordinary skilled in the art before the effective filing date of the claimed invention that administering a substance that knocks down or knocks out the expression of KAT7, such as a CRISPR Cas system comprising a Cas9 and sgRNAs targeting KAT7, to human cells would inhibit senescence. This would have been obvious because Yu teaches that knockdown of KAT7 reduced KLF6 acetylation thereby reducing KLF6’s activity, Yu teaches that KLF6 activates p21, and Macip teaches that inhibition of p21 inhibits senescence. Therefore, a skill artisan would have a reasonable expectation that a CRISPR Cas system comprising a Cas9 and sgRNAs targeting KAT7 would inhibit senescence via the reduction of KLF6 activity and p21.
Response to Arguments
Applicant's arguments filed 12/09/2025 have been fully considered but they are not persuasive. Applicant contends that Yu and Macip belong to technical fields that are sufficiently distinct whereby one of ordinary skill in the art in either field would not be motivated to incorporate teachings from references in the other field. Applicant notes that although Yu studies the role of KAT7 in kidney tissue via the KLF6/p21 pathway Yu does not teach or suggest to one of ordinary skill in the art that inhibiting KAT7 can be used to delay, treat, or prevent aging. Indeed, Applicant submits that Yu's focus is on diseases such as kidney fibrosis, not the cellular/organismal aging being addressed in the present application. Applicant also contends that Macip does not make any references to KAT7.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Yu teaches a link between KAT7 expression and p21 expression, and since it is known in the art that p21 has a direct correlation with senescence, a skill artisan would have reason to conclude that a reduction in KAT7 could affect senescence as claimed, regardless of the technical fields from each reference.
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
Conclusion
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 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 TIFFANY N GROOMS whose telephone number is (571)272-3771. The examiner can normally be reached M-F 830-530.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jennifer Dunston can be reached at 571-272-2916. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/TIFFANY NICOLE GROOMS/Examiner, Art Unit 1637
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