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 .
Claims 1, 3, 6, 8, 10-11, 14-16, 18, 20, and 22 are amended.
Claim 2 is canceled.
Claims 1, 3, 5-6, 8, 10-11, 13-16, 18, 20-22, and 24-25 remain pending and are considered herein.
Claim Status, Canceled Claims
In light of the cancelation of Claim 2, all rejections/objections thereto are withdrawn.
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.
In light of the amendments, the rejections of Claims 3, 6, 8, 11, 14-16, and 22 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a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention, are withdrawn.
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.
In light of the amendments, the rejections of Claims 1, 3, 5-6, 8, 10-11, 13-16, 18, 20-22, and 24-25 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, are withdrawn.
To wit, Claim 1 now requires the NLS to be “tagged to the Acr protein”. The examiner considered whether or not required the NLS to be functionally linked for the Acr protein, i.e., in a manner that requires its action as a nuclear localization signal and localizes the Acr protein to the nucleus. Looking to the specification, the same language is used to indicate such functional language as “tagged” as meaning localization to the nucleus (e.g., pp. 5-6 paragraph bridging). Thus, the Examiner feels that the Artisan would know, reading the specification that the NLS was operatively linked when it is “tagged” to the Acr protein, thereby localizing the Acr to the nucleus. The present explanation was made in light of Applicant’s decision to avoid the “operably linked” language the examiner chose, and instead use “tagged”, in order to overcome the present rejection.
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.
In light of the Argument, the rejections of Claims 1, 3, 6, 8, 10-11, 13-16, 18, 20-22, and 24-25 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, are withdrawn.
To wit, upon further consideration, Applicant argues that the term germline specific is not actually germline specific, but simply a promoter that works in the germline cells and provides examples by way of art supplied but not cited in an IDS (p. 8 of the response of 6/11/26). The Examiner reviewed the specification and does find that such matches Applicant’s teaching in the specification (p. 6, paragraphs 4-5). And thus, the rejections are withdrawn.
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.
In light of the amendment to Claim 18, the rejections of Claim 18, 20-22 and 24-25 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, are withdrawn.
To wit, the construct is no longer “optionally” present.
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.
Claims 1, 3, 6, 8, 10-11, 14-16, 18, 20, and 22 remain 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.
The claims are generic for Acr fragments and variants, as seen from Claim 3. I.e., Claim 3 limits the Acr protein to being AcrIIA4, consisting of, or being substantially set out in SEQ ID NO: 11, or a fragment or variant of 80% identity. The claiming of “substantially set out” indicates an intent to retain the AcrIIA4 activity, but the 80% fragment/variant is not even required to contain the activity of AcrIIA4 as claimed. Moreover, the claiming of AcrIIA4 in Claim 3 indicates that the broad claims’ recitations of Acr protein, means these may be any Acr protein, and may be any portion of an Acr protein. Finally, the broad claims (those that do not depend from Claim 3, still are generic for lower identity than 80%, and may be to many other distinct Acr proteins, just as in the previous version of this rejection in the OA of 3/11/26.
The specification provides for variants and fragments, as having 40% or more sequence identity (e.g., p. 36, paragraph 6). Still further, The same provides for anything with 65%, 70%, 75%, 80%, 85%, 90%, 92%, 95%, 97%, 98% or 99% identity with any of these sequences, which may refer to an Acr protein (pp. 36-37, paragraph bridging), e.g., SEQ ID NO: 11 appears in Claim 3 and is disclosed as the sequence of an Acr protein (p. 6, paragraphs 2-3), which is presumably AcrIIA4, as Applicant has claimed the same (Claim 3). But, examples of these variants and fragments are not provided. However, Applicant supplies a table listing many Acr proteins, and the Cas type and organism they are associated with.
The art teaches that Acr proteins are defined based on their action, and the action may differ, including interruption of CRISPR-Cas complexes, target DNA binding, blocking DNA/RNA cleavage, and enzyme modification/degradation of signalling molecules. Thus, given the distinctions, the Acrs do not provide information that can identify the generic structure required to obtain each function type. Choudhary, et al. (2023) “A comprehensive appraisal of mechanism of anti-CRISPR proteins: an advanced genome editor to amend the CRISPR gene editing”, Frontiers in Plant Science, 14: 1164461 (14 pages), e.g., ABSTRACT. Moreover, sequence identity does not mean the same function, and proteins with higher sequence identity can have distinct function (e.g., He, et a. (2008) “NMR structures of two designed proteins with high sequence identity but different fold and function”, Proceedings of the National Academy of Science, USA, 105(38): 14412-17, ASTRACT). Conversely, other proteins have lower identity but have the same function (e.g., Martin, et al. (1998) “Protein folds and functions”, Structure, 6(7): 875-84, ABSTRACT, Conclusions).
Thus, given that the Acr proteins are not necessarily structurally related, and the Art shows that proteins with higher identity can have distinct function, and proteins with lower identity can have the same function, coupled with the absence of description and art providing for the structure and function of the Acr proteins encompassed, the Artisan would not know which of the great many distinct structures encompassed provide for the action of the Acr fragments and variants.
Response to Argument – Description, variants and fragments with 80% identity
Applicant’s argument of 6/11/26 have been considered but is not found persuasive.
Applicant argues that they have amended to have at least 80% identity, and thus, the rejection is overcome (p. 9, paragraph 4).
Such is not persuasive. The Examiner has shown how high identity provides for distinct functions, while similar functions may be had with lower identity. Combined with the lack of description in the art for the structure and function of each of these proteins, and the lack of description beyond listing a sequence order, all demonstrates that Applicant does not have possession of generic variants and generic fragments of all of the genera of Acr proteins having even 80% identity to the specific claimed sequence of SEQ ID NO: 11, much less 80% identity to the known sequence of all the Acr proteins in the art, which are shown to have distinct functions to begin with.
Claims Free of the Art
For clarity of record, the Art is again mentioned here. The first publication to disclose the anti-gene drives disclosed, is Inventor Cristani and Galizi’s article: Taxiarchi, et al. (2021) “A genetically encoded anti-CRISPR protein constrains gene drive spread and prevents population suppression”, Nature Communications, 12: 3977, 8 pages long. The publication was published one day after Applicant’s foreign priority date. Moreover, as discussed in Txiarchi, several approaches had been considered, but Applicant’s disclosure was the first to use the Acr proteins to inhibit the Cas9/Cpf1-gRNA complex, in the germ line. There was no teaching or motivation in the prior to arrive at the presently-claimed invention. Thus, the claims are free of the Art.
Conclusion
No claim is allowed.
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 ROBERT M KELLY whose telephone number is (571)272-0729. The examiner can normally be reached M-F: 8a-5p.
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ROBERT M. KELLY
Examiner
Art Unit 1638
/ROBERT M KELLY/Primary Examiner, Art Unit 1638
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