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 .
Amendments
In the reply filed 10/15/2025, Applicant has amended Claims 1, 6, and 9.
Claims 1-12 are under consideration.
Maintained Objection to Drawings
Sequence Compliance
Figure 1 of the Specification does not conform to sequence rules, requiring the use of a proper “SEQ ID NO:” (37 CFR 1.821-1.825). Specifically, although Figure 1 is indicated as SEQ ID NO:207. The sequence depicted in Figure 1 is NOT SEQ ID NO:207, wherein the “UUU” bulge of Stem 2 should be “CUC” according to the filed sequence.
Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Withdrawn 35 USC § 112(a)
The prior rejection of Claims 1-12 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112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement is withdrawn in light of Applicant’s amendments of Claim 1 to limit the gRNA to modifications of SEQ ID NO:219.
The prior rejection of Claims 1-12 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as not reasonably provide enablement for a genus of Nme sgRNA comprising a truncated Stem 2 region of 24 nucleotides is withdrawn in light of Applicant’s amendments of Claim 1 to limit the gRNA to modifications of SEQ ID NO:219.
Maintained 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 obviousness-type 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); and 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 a nonstatutory double patenting ground provided the conflicting application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement.
Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b).
Claims 1-12 stand provisionally rejected on the grounds of nonstatutory double patenting as being unpatentable over claim 92 of copending Application No. 17/964,611. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented
The subject matter claimed in the instant application is disclosed in the referenced application as follows: the Nme sgRNA of cited application anticipates the composition of instant application. It is clear that elements of the cited application claims are to be found in instant claims. The difference between the cited application claims and the instant claims lies in the fact that the cited application claims are much more specific to modified nucleosides. Thus the invention of said claims of the cited application are in effect “species” of the “generic” invention of the instant claim. It has been held that the generic invention is “anticipated” by the “species”. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993).
Since the instant application claims are anticipated by cited application claims, said claims are not patentably distinct.
RESPONSE TO ARGUMENTS
Applicant's arguments filed on 10/15/2025 are acknowledged.
Applicant argues that in light of the claim amendments, instant claims have not been compared with copending application.
Applicant's arguments have been fully considered but they are not persuasive.
In response to Applicant's argument, cited copending Application claim 92 comprises a Nme sgRNA comprising a truncated Stem 2 region relative to SEQ ID NO:219, which is 24 nucleotides in length and with a truncated repeat:anti-repeat region relative to SEQ ID NO: 219 (e.g., copending SEQ ID NO:108). Accordingly, Applicant's arguments fail to comply with 37 CFR 1.111(b) because they amount to a general allegation that the claims define a patentable invention without specifically pointing out how the language of the claims patentably distinguishes them from the referenced application.
Claims 1-9 stand provisionally rejected on the grounds of nonstatutory double patenting as being unpatentable over claims 58-72 of copending Application No. 18/612,111. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented
The subject matter claimed in the instant application is disclosed in the referenced application as follows: the AAV Nme sgRNA comprising a stem 2 region of 24 nucleotides of cited application anticipates the composition of instant application the composition of instant application. It is clear that elements of the cited application claims are to be found in instant claims. The difference between the cited application claims and the instant claims lies in the fact that the cited application claims are much more specific with respect the sgRNA being in an AAV vector. Thus the invention of said claims of the cited application are in effect “species” of the “generic” invention of the instant claim. It has been held that the generic invention is “anticipated” by the “species”. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993).
Since the instant application claims are anticipated by cited application claims, said claims are not patentably distinct.
RESPONSE TO ARGUMENTS
Applicant's arguments filed on 10/15/2025 are acknowledged.
Applicant argues that in light of the claim amendments, instant claims have not been compared with copending application.
Applicant's arguments have been fully considered but they are not persuasive.
In response to Applicant's argument, cited copending Application comprises a Nme sgRNA comprising a truncated Stem 2 region relative to SEQ ID NO:219 (copending claim 58), which is 24 nucleotides in length (copending claim 66), and with a truncated repeat:anti-repeat region relative to SEQ ID NO: 19 (copending claim 68). Accordingly, Applicant's arguments fail to comply with 37 CFR 1.111(b) because they amount to a general allegation that the claims define a patentable invention without specifically pointing out how the language of the claims patentably distinguishes them from the referenced application.
Conclusion
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.
No claims are allowed.
Examiner Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ARTHUR S LEONARD whose telephone number is (571)270-3073. The examiner can normally be reached on Mon-Fri 9am-5pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, James Doug Schultz can be reached on 571-272-0763. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ARTHUR S LEONARD/Examiner, Art Unit 1631