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 .
Applicants’ reply to the February 11, 2026 Office Action, filed May 11, 2026 is acknowledged. Applicants previously canceled claims 3-4, 7-22, 24-37, 44-46, 49-60, 64, 66-67, 72, and 74-82. Claims 47-48, 61, and 68-70 remain withdrawn from consideration, as being drawn to a non-elected invention. Applicants amend claims 1-2, 5-6, 23, 41, 83-84 and withdrawn claims 47, 61, and 68-70. Claims 1-2, 5-6, 23, 38-43, 62-63, 65, and 83-84 are under examination.
Any objection or rejection of record in the previous Office Action, mailed February 11, 2026, which is not addressed in this action has been withdrawn in light of Applicants’ amendments and/or arguments. This action is FINAL.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, or 365(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 119(e) as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of 35 U.S.C. 112 (pre-AIA ). See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
Regarding claims 1-2, 5-6, 23, 38-43, 62-63, 65, and 83-84, the disclosure of the prior-filed application, U.S. Provisional Patent Application No. 62/527,957 fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112 (pre-AIA ), first paragraph for one or more claims of this application. These applications fail to provide support for the claims under examination, since there is no disclosure therein of a Type VI-D CRISPR-Cas effector protein having a sequence provided in Table 2. Although the application discloses CRISPR protein families formed around a WYL domain, the application does not disclose the claimed Type VI-D CRISPR-Cas effector proteins or their sequences. Thus, the priority date of claims 1-2, 5-6, 23, 38-43, 62-63, 65, and 83-84 is deemed to be the filing date of U.S. Provisional Patent Application No. 62/572,367, filed October 13, 2017.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-2, 23, 38-43, 62-63, 65, and 83 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 5-6, 8-10, 14, and 21-23 of U.S. Patent No. 10,392,616.
Although the claims at issue are not identical, they are not patentably distinct from each other because both the ‘616 patent and the instant application claim a CRISPR-Cas system.
Regarding claims 1-2 and 83, both the ‘616 patent and the instant application claim a CRISPR-Cas system comprising a guide RNA having a direct repeat sequence having a sequence provided in Table 3, which can be SEQ ID NO: 153 and a spacer sequence and a CRISPR-Cas effector protein having the sequence of SEQ ID NO: 2, which is an amino acid sequence listed in Table 2, and which is a Type VI-D CRISPR-Cas effector protein (claims 1, 8-10, and 14).
Regarding claim 23, both the ‘616 patent and the instant application claim that the Type VI-D CRISPR-Cas effector protein has at least two HEPN domains and the guide RNA has direct repeat sequence having at least 95% identid6 to SEQ ID NO: 153, which is a sequence provided in Table 3 (claims 2-3, 10, and 14).
Regarding claim 38, both the ‘616 patent and the instant application claim that the target is an RNA target (claim 22).
Regarding claims 39-40, both the ‘616 patent and the instant application claim a delivery system, which can be a nanoparticle, a liposome, an adeno-associated virus, and exosome, a microvesicle, or a gene-gun (claim 21).
Regarding claims 41-43, both the ‘616 patent and the instant application claim a cell comprising the Type VI-D CRISPR-Cas system (claim 23).
Regarding claims 62-63 and 65, both the ‘616 patent and the instant application claims a fusion protein where the CRISPR-Cas effector protein comprises a base-editing domain, an RNA methyltransferase, an RNA demethylase, a splicing modifier, a localization factor, or a translation modification factor (claims 5-6).
Therefore, the claims are not deemed to be patentably distinct.
Claims 1-2, 5-6, 23, 38-43, 62-63, 65, and 83-84 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 5, 8-9, 11-12, 14, and 18-20 of U.S. Patent No. 11,168,322.
Although the claims at issue are not identical, they are not patentably distinct from each other because both the ‘322 patent and the instant application claim a CRISPR-Cas system.
Regarding claims 1-2 and 83, both the ‘322 patent and the instant application claim a CRISPR-Cas system comprising a guide RNA having a direct repeat sequence and a spacer sequence and a CRISPR-Cas effector protein having the sequence of SEQ ID NO: 2, which is an amino acid sequence listed in Table 2, and which is a Type VI-D CRISPR-Cas effector protein (claim 1).
Regarding claims 5-6, both the ‘322 patent and the instant application claim that the accessory protein has a WYL domain and has a sequence having at least 95% identity to SEQ ID NO: 81, which is a sequence provided in Table 4, which is interpreted as including the specific WYL domain (claims 8-9 and 11-12).
Regarding claim 23, both the ‘322 patent and the instant application claim a direct repeat sequence having at least 95% identid6 to SEQ ID NO: 153, which is a sequence provided in Table 3 (claims 2-3).
Regarding claim 38, both the ‘322 patent and the instant application claim that the target is an RNA target (claim 5).
Regarding claims 39-40, both the ‘322 patent and the instant application claim a delivery system, which can be a nanoparticle, a liposome, an adeno-associated virus, and exosome, a microvesicle, or a gene-gun (claims 18-19).
Regarding claims 41-43, both the ‘322 patent and the instant application claim a cell comprising the Type VI-D CRISPR-Cas system (claim 20).
Regarding claims 62-63 and 65, both the ‘322 patent and the instant application claims a fusion protein where the CRISPR-Cas effector protein comprises a base-editing domain, an RNA methyltransferase, an RNA demethylase, a splicing modifier, a localization factor, or a translation modification factor (claim 14).
Regarding claim 84, both the ‘322 patent and the instant application claim that the direct repeat sequence can have at least 95% identity to SEQ ID NO: 72 (claims 2-3).
Therefore, the claims are not deemed to be patentably distinct.
Response to Amendments and Arguments
Regarding the rejections under 35 U.S.C. §§ 112(b)/second paragraph and 101, Applicants’ amendments and arguments have been fully considered, and are deemed to be persuasive. Therefore, these rejections are withdrawn.
Regarding the non-statutory double patenting rejections over U.S. Patent Nos. 10,392,616 and 11,168,322, Applicants request that these rejections be held in abeyance until the rejections outstanding in the instant application are overcome. Therefore, these rejections are maintained.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Hsu et al. (U.S. Patent No. 10,476,825, issued November 12, 2019, filed March 27, 2018, and claiming priority to U.S. Provisional Patent Application Nos. 62/548,846; 62/572,963; and 62/639,178; filed August 22, 2017; October 16, 2017; and March 6, 2018, respectively and PCT Patent Application No. WO 2019/040664, published February 28, 2019, filed August 22, 2018 and claiming priority to U.S. Patent Application No. 15/937,699 (U.S. Patent No. 10,467,825) and U.S. Provisional Patent Application Nos. 62/548,846; 62/572,963; and 62/639,178; filed August 22, 2017; October 16, 2017; and March 6, 2018, respectively, and cited in the Information Disclosure Statement filed December 17, 2025) disclose Cas13d (Type VI-D) CRISPR-Cas systems (abstract). However, both the ‘825 U.S. Patent and the ‘664 PCT Patent Application publication do not disclose or suggest a Cas13d CRISPR-Cas effector protein having the instantly claimed sequences. While the ‘825 U.S. Patent and the ‘664 PCT Patent Application publication disclose a Cas13d CRISPR-Cas effector protein having 98.7% similarity over a portion of the instantly claimed Type VI-D CRISPR-Cas effector protein, there is only a 57.6% similarity to the entire claimed Type VI-D CRISPR-Cas effector protein (see Appendix I).
Yan et al. (70(2) Molecular Cell 327-339 (2018), and cited in the Information Disclosure Statement filed March 23, 2020) disclose Type VI-D CRISPR-Cas effector protein systems isolated from Eubacterium siraeum (Es) and Ruminococcus sp. (Rsp) that are active in CRISPR RNA processing and target and collateral RNA cleavage (abstract). Yan et al. disclose that these CRISPR-Cas effector proteins have WYL domains (page 10).
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 NANCY J LEITH whose telephone number is (313)446-4874. The examiner can normally be reached Monday - Thursday 8:00 AM - 6:30 PM.
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NANCY J. LEITH
Primary Examiner
Art Unit 1636
/NANCY J LEITH/Primary Examiner, Art Unit 1636
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