DETAILED ACTION
Status of the Application
Claims 44, 46-49, 52-71, 73 are pending.
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 amendment of claims 44, 46-49, 73 as submitted in a communication filed on 1/21/2026 is acknowledged.
Applicant elected Group I, drawn to a SpCas9 protein, the combination of positions 695, 926, 497, 661, and 169, the combination of substitutions N497A, R661A, Q695A, Q926A, and L169A, a nuclear localization signal, the combination of substitutions D10A and H840A, and VP64, in a communication filed on 4/15/2024.
New claim 73 is directed to a non-elected invention as it requires combinations of positions which were not elected (e.g., combinations that require position 450 without position 169 in addition to additional positions that were not previously presented (e.g., positions 14, 15, 55, 63, 78, etc.). As previously indicated, in view of the election of Group I, the combination of positions 695, 926, 497, 661, and 169, the combination of substitutions N497A, R661A, Q695A, Q926A, and L169A, the election of a nuclear localization signal, the combination of substitutions D10A and H840A, and the transcriptional activation domain of VP64, claims 47, 49, 55-65 are directed to a non-elected invention. Claims 47, 49, 55-71, 73, which require non-elected heterologous domains and/or non-elected substitutions at position corresponding to positions 450 and/or 1150 of the polypeptide of SEQ ID NO: 1, are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 4/15/2024.
Claims 44, 46, 48, 52-54 are directed in part to the elected invention. They are at issue and will be examined to the extent they encompass the elected invention.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.
Claim Rejections - 35 USC § 112(b) or Second Paragraph (pre-AIA )
Claims 44, 46, 48, 52-54 remain 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 pre-AIA the applicant regards as the invention. New grounds of rejection are necessitated by amendment.
Claim 44 (claims 44, 46, 48, 52-54 dependent thereon) is indefinite in the recitation of “and substitutions at (i) D10A or D10N and/or substitutions at (ii) H840A,,,G840Y of the polypeptide sequence of SEQ ID NO: 1” for the following reasons. The term “substitutions at” implies that the subsequent phrase would define positions at which the substitutions should be present. However, the terms “D10A”, “D10N” , “H840A”, “H840N” and “H840Y” are not positions but rather substitutions. Therefore, it is unclear if the claim is limiting the SpCas9 protein to have the specific substitutions recited (e.g., D10A) or if the claim is simply limiting the positions at which the mutations should be present (e.g., at a position corresponding to position 10 of the polypeptide sequence of SEQ ID NO: 1). If the intended limitation is “substitutions that correspond to (i) substitutions D10A or D10N in the polypeptide sequence of SEQ ID NO: 1, and/or (ii) substitutions H840A, ..or H840Y in the polypeptide sequence of SEQ ID NO: 1”, the claim should be amended accordingly. For examination purposes, the Examiner will interpret the claim to recite “substitutions that correspond to (i) substitutions D10A or D10N in the polypeptide sequence of SEQ ID NO: 1, and/or (ii) substitutions H840A, ..or H840Y in the polypeptide sequence of SEQ ID NO: 1”. Correction is required.
When amending the claims, applicant is advised to carefully review all examined claims and make the necessary changes to ensure proper antecedent basis and dependency.
Claim Rejections - 35 USC § 112(a) or First Paragraph (pre-AIA )
Claims 44, 46, 48, 52-54 were 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 and enablement requirements.
In view of Applicant’s amendment of claims 44, 48, which now require a SpCas9 protein, wherein said SpCas9 protein comprises all of SEQ ID NO: 1 except for (i) the substitution of the amino acid at the position corresponding to position 695, 926, 497 and 661 of SEQ ID NO: 1 with another amino acid as well as the substitution of the amino acid at the position corresponding to position 169, 450 and/or 1135 of SEQ ID NO: 1 with another amino acid, or (ii) the substitution of the amino acid at the position corresponding to positions 695, 926, 497, and 661 of SEQ ID NO: 1 with another amino acid, the substitution of the amino acid at the position corresponding to position 169, 450 and/or 1135 of SEQ ID NO: 1 with another amino acid, and substitutions that correspond to (a) substitutions D10A or D10N in the polypeptide sequence of SEQ ID NO: 1, and/or (b) substitutions H840A, H480N or H840Y in the polypeptide sequence of SEQ ID NO: 1, wherein said SpCas9 protein has the ability to interact with a guide RNA and a target DNA, these rejection are hereby withdrawn.
Double Patenting
Claims 44, 46, 48, 52-54 remain rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 6-12 of U.S. Patent No. 12,312,613.
Claims 44, 46, 48, 52-54 remain rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 2-8 of U.S. Patent No. 12,264,341.
These rejections have been discussed at length in the prior Office action. They are maintained for the reasons of record and those set forth below.
Applicant reiterates the previously presented argument of 9/24/2025, indicating that these patents have a patent term filing date of January 24, 2021, which is 5 years after the that of the claims of the instant application. Applicant had previously argued that because the reference patents have a later patent term filing date, they are not proper obvious-type double patenting references even though accrual of PTA in the present application might result in a patent issuing from the present application that expires later than the reference patents, citing Ex parte Baurin.
Applicant’s arguments have been fully considered but not deemed persuasive to overcome the instant rejection. As previously indicated, PTA is not an issue in the instant case. Instead, the issue is that Applicant has already received two patents for inventions that are obvious variations of the invention being claimed in the instant application. The Examiner has previously recognized the differences in patent term filing dates between the instant application and those of U.S. Patent No. 12,312,613 and U.S. Patent No. 12,264,341. However, it is noted that there is no prohibition to issue a double patenting rejection of the obviousness-type in the case where the reference patents have a later patent term filing date. See Chart II-B_AIA in MPEP § 804 and MPEP § 804(I)(A). Applicant is reminded that in addition to prevent prolongation of patent term, the doctrine of nonstatutory double patenting also seeks to prevent the possibility of multiple suits against an accused infringer by different assignees of patents claiming patentably indistinct variations of the same invention. See MPEP § 804. Therefore, for the reasons of record and those set forth above, the claimed invention is deemed an obvious variation of the inventions of (a) claims 6-12 of U.S. Patent No. 12,312,613, and (b) claims 2-8 of U.S. Patent No. 12,264,341.
Conclusion
No claim is in condition for allowance.
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 date of this final action.
Applicant is advised that any Internet email communication by the Examiner has to be authorized by Applicant in written form. See MPEP § 502.03 (II). Without a written authorization by Applicant in place, the USPTO will not respond via Internet email to any Internet correspondence which contains information subject to the confidentiality requirement as set forth in 35 U.S.C. 122. Sample written authorization language can be found in MPEP § 502.03 (II). An Authorization for Internet Communications in a Patent Application or Request to Withdraw Authorization for Internet Communications form (SB/439) can be found at https://www.uspto.gov/patent/forms/ forms-patent-applications-filed-or-after-september-16-2012, which can be electronically filed.
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Any inquiry concerning this communication or earlier communications from the examiner should be directed to DELIA M RAMIREZ, Ph.D., whose telephone number is (571) 272-0938. The examiner can normally be reached on Monday-Friday from 8:30 AM to 5:00 PM. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert B. 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.
/DELIA M RAMIREZ/Primary Examiner, Art Unit 1652
DR
April 3, 2026