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 .
Applicant’s cancellation of claim 28, amendment of claims 1, 2, 4, 11, 13, 16, 19, 22, 25 and the addition of new claim 88-89, in the paper of 5/26/2026, is acknowledged. Applicants' argument filed on 5/26/2026, have been fully considered and are deemed to be persuasive to overcome some of the rejections previously applied. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn Claims 1-4, 8-14, 16, 17, 19, 20, 22, 23, 25, 26 and 88-89 are still at issue and are present for examination.
Election/Restrictions
Applicant's election without traverse of the invention of Group 1, claims 1-4, 8-14, 16, 17, 19, 20, 22, 23, 25 and 26 to a composition comprising a helper enzyme comprising a helper enzyme having 90% sequence identity to SEQ ID NO:2 or a nucleotide encoding said helper enzyme , in the paper of 12/31/2025, is acknowledged. Applicant's election without traverse of the Species Group 1 species: mutation S8P, Species Group 2 species: MER75 end sequence, Species Group 3 species: SEQ ID NO:13, in the paper of 12/31/2025, is acknowledged.
Claims 16, 17, 20-26, 28 (Group 2) and the subject matter of Group 3 drawn to a composition comprising a gene transfer construct comprising end sequences having at least 90% sequence identity to SEQ ID NO:11 and SEQ ID NO:16 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Claim Objections
Claims 4, 8-14 and 88-89 are objected to because of the following informalities” Claims 4, 8-14 and 88-89 depend from rejected claim 1.
Appropriate correction is required.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1 and 2 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter.
Claims 1 and 2 are directed to a composition comprising a helper enzyme, or a nucleotide sequence encoding the same, having gene cleavage (Exc) and/or gene integration (Int) activity, and at least about 95% identity to the amino acid sequence of SEQ ID NO: 2, that is not patent-eligible pursuant to the Supreme Court decision in Association for Molecular Pathology v. Myriad Genetics, Inc., 106 USPQ2d 1972 (June 13, 2013). WO 2023081815 A1 which discloses a naturally occurring protein from Pteropus vampyrus comprising the amino acid sequence of instant SEQ ID NO:2, which has gene cleavage (Exc) and/or gene integration (Int) activity, evidence that a composition comprising a helper enzyme, or a nucleotide sequence encoding the same, having gene cleavage (Exc) and/or gene integration (Int) activity and at least about 95% identity to the amino acid sequence of SEQ ID NO: 2, is a naturally occurring protein and/or encoding nucleotide sequence and is thus not patent eligible.
This rejection was stated in the previous office action as it applied to the previous claims. In response applicants have amended the claims and traverse the rejection as it applies to the newly amended claims. (It is acknowledged that claim 2 was mistakenly left out of the previous rejection, however, it should have been included for the same reasons stated for claim 1. Any inconvenience to applicant is regretted).
Applicants traverse the rejection on the basis that applicants have amended the claim such that the helper enzyme has at least 95% identity to the amino acid sequence of SEQ ID NO:2 and Uniprot Accession No. F7FDY8 and SEQ ID NO:2 have only 90.94% identity to one another.
Applicants amendment of the claims and applicants complete argument is acknowledged and has been carefully considered, however, is not found persuasive for the reasons previously made of record and for those reasons repeated herein.
Regardless of applicants amendment of the claims, the composition comprising a helper enzyme, or a nucleotide sequence encoding the same, having gene cleavage (Exc) and/or gene integration (Int) activity, and comprising the amino acid sequence of SEQ ID NO: 2 is directed to a naturally occurring enzyme. This is evidenced by WO 2023/081815 who teach that the helper enzyme comprising the amino acid sequence of SEQ ID NO:2 is a naturally occurring protein from Pteropus vampyrus.
Applicants specification supports that the helper enzyme comprising the amino acid sequence of SEQ ID NO:2 is a naturally occurring protein from Pteropus vampyrus, in that applicants specification teaches that “the present disclosure provides, in aspects and embodiments, compositions comprising recombinant mammalian helper enzymes” (page 2, lines 19-20). Further applciants specification discloses that SEQ ID NO:2 is an extended Pteropus vampyrus amino acid sequence.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim(s) 3 is 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
This rejection was stated in the previous office action as it applied to the previous claims. In response applicants have amended the claims and traverse the rejection as it applies to the newly amended claims.
Applicants traverse the rejection on the basis applicants submit that claim 1 has been amended to recite the helper enzyme has at least 95% identity to the amino acid sequence of SEQ ID NO: 2.
Applicants amendment of the claims and applicants complete argument is acknowledged and has been carefully considered, however, is not found persuasive for the reasons previously made of record and for those reasons repeated herein.
Claim(s) 3 continues to be directed to all possible compositions comprising a recombinant helper enzyme, or a nucleotide sequence encoding the same, having gene cleavage (Exc) and/or gene integration (Int) activity and at least about 95% identity to the amino acid sequence of SEQ ID NO: 2, including those helper enzymes having mutations which confer hyperactivity. The specification, however, only provides the representative species of that helper enzyme comprising the amino acid sequence of SEQ ID NO: 2, and three mutations at positions corresponding to S8P, C13R and N125K relative to SEQ ID NO:10 (Myotis lucifugus) which confer hyperactivity, encompassed by these claims. There is no disclosure of any particular structure to function/activity relationship in the disclosed species. The specification also fails to describe additional representative species of these helper enzymes and mutations which confer hyperactivity by any identifying structural characteristics or properties, for which no predictability of structure is apparent.
Given this lack of additional representative species as encompassed by the claims, Applicants have failed to sufficiently describe the claimed invention, in such full, clear, concise, and exact terms that a skilled artisan would recognize Applicants were in possession of the claimed invention.
Applicant is referred to the revised guidelines concerning compliance with the written description requirement of U.S.C. 112, first paragraph, published in the Official Gazette and also available at www.uspto.gov.
Claim Rejections - 35 USC § 102
The rejection of claim(s) 1 and 8 under 35 U.S.C. 102(a)(1) as being anticipated by Hood et al. (US 8,586,006) is withdrawn based upon applicants amendment of the claims in the paper of 5/26/2026.
Remarks
No claim is allowed.
Conclusion
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 RICHARD G HUTSON whose telephone number is (571)272-0930. The examiner can normally be reached 6-3 EST Mon-Fri.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert Mondesi can be reached at (408) 918-7584. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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rgh
6/26/2026
/RICHARD G HUTSON/Primary Examiner, Art Unit 1652
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