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 .
DETAILED ACTION
1. Claims 1, 6, 8, 9, 11 are amended. Claims 3, 19-21, 23, 25, 27 are canceled. Claims 22, 24, 26 are withdrawn. Claims 1, 2, 4-18 are under consideration.
Specification
2. (previous objection, withdrawn) The disclosure was objected to because of informalities.
Applicant contends: a substitute specification has been submitted.
In view of applicant’s amendments, the objection is withdrawn.
Claim Objections
3. (previous objection, withdrawn) Claims 6, 8, 9 were objected to because of the following informalities:
Applicant contends: the claims have been amended.
In view of applicant’s amendments, the objection is withdrawn.
Claim Rejections - 35 USC § 103
4. (previous rejection, withdrawn) Claims 5, 6 were rejected under 35 U.S.C. 103 as being unpatentable over Doudna et al. in view of Lee et al. as applied to claims 1, 2, 4, 7-13, 16 above, and further in view of Wong et al. ("WU-CRISPR: characteristics of functional guide RNAs for the CRISPR/Cas9 system," Genome Biology DOI: 10.1186/s13059-015-0784-0: 1-8 (2015); previously cited).
See claims 5, 6 as submitted 2/17/2026.
Applicant contends: the sgRNAs of Wong et al. are entirely RNA; uracil residues lead to decreased CRISPR activity.
In view of applicant’s amendments, the rejection is withdrawn.
5. (previous rejection, withdrawn) Claims 17, 18 were rejected under 35 U.S.C. 103 as being unpatentable over Doudna et al. in view of Lee et al. as applied to claims 1-4, 7-13, 16 above, and further in view of Garcia Guerra et al. (WO2020044039A1; previously cited).
Applicant contends: Garcia Guerra et al. teaches a different use for toeholds; toeholds are hybridized to a different strand; in the present application, it refers to a stem loop structure; the configuration is different in each case, Garcia Guerra is clear that the toehold regions should not be self-complementary; each disclosure uses the term in a different way to achieve a different function.
Applicant’s arguments are considered and found persuasive, and the rejection is withdrawn.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
6. (previous rejection, maintained; withdrawn as to canceled claim 3) Claims 1, 2, 4, 7-13, 16 are rejected under 35 U.S.C. 103 as being unpatentable over Doudna et al. (US20190241954)(cited in applicant's IDS submitted 5/6/2022) in view of Lee et
al. (US20190218547)(cite in applicant's IDS submitted 5/6/2022).
See claims 1, 2, 4, 7-13, 16 as submitted 2/17/2026.
Applicant contends: the ordinarily skilled artisan would not be motivated to use an extension sequence; Example 1 lists extension sequences in Table 1; all contain U residues; claim 1 specifies that the extension sequence is 8 nucleotides or more while the present claims are limited to 7 nucleotides; 7 nucleotides is not merely a design choice but shows a dramatic and unexpected improvement; other nucleic acids did not show the same effect; the cited combination of references does not teach each and every element of the present claims.
Applicant’s arguments are considered but found unpersuasive.
See the rejection as recited in the previous Office Action.
As to applicant’s amendments, it is noted that Lee et al. already teaches: guide RNA comprising ssDNA or ssRNA having 1-19 nucleotides (Fig. 1C; [0034](as recited in claim 1); Doudna et al. teaches: FAM-TTATT-3IABkFQ (Table 2)(as recited in claims 8, 9).
Response to Arguments
Turning to applicant’s arguments, first, in response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
As to the teachings of Lee et al., the teachings of Lee et al. are not so limited, such as to Examples, as applicant contends. To reiterate as previously indicated, Lee et al. teaches: guide RNA comprising extension sequence linked to 3' end of guide sequence [0006]; comprising ssDNA or ssRNA having 1-19 nucleotides (Fig. 1C; [0034])(as recited in claim 1; interpreted to comprise 7 nucleotides as recited in claim 1 (See MPEP 2111)); wherein extension can enhance efficiency [0138](See MPEP 2121: I. PRIOR ART IS PRESUMED TO BE OPERABLE/ ENABLING: When the reference relied on expressly anticipates or makes obvious all of the elements of the claimed invention, the reference is presumed to be operable. Once such a reference is found, the burden is on applicant to rebut the presumption of operability. In re Sasse, 629 F.2d 675, 207 USPQ 107 (CCPA 1980). See also MPEP 716.07. See also In re Antor Media Corp., 689 F.3d 1282, 103 USPQ2d 1555 (Fed. Cir. 2012); see also MPEP 2121.01: II. 35 U.S.C. 103 REJECTIONS AND USE OF INOPERATIVE PRIOR ART: “Even if a reference discloses an inoperative device, it is prior art for all that it teaches.” Beckman Instruments v.LKB Produkter AB, 892 F.2d 1547, 1551, 13 USPQ2d 1301, 1304 (Fed. Cir. 1989). Therefore, “a non-enabling reference may qualify as prior art for the purpose of determining obviousness under 35 U.S.C. 103.” Symbol Techs. Inc. v. Opticon Inc., 935 F.2d 1569, 1578, 19 USPQ2d 1241, 1247 (Fed. Cir. 1991)). Applicant has not appeared to present evidence of lack of operability or evidence of unexpected results against a control or background of unexpected results, rather argument (See MPEP 716.01(c): The arguments of counsel cannot take the place of evidence in the record. In re Schulze, 346 F.2d 600, 602, 145 USPQ 716, 718 (CCPA 1965)).
The rejection is maintained for reasons of record.
7. (previous rejection, maintained) Claims 14, 15 are rejected under 35 U.S.C. 103 as being unpatentable over Doudna et al. in view of Lee et al. as applied to claims 1, 2, 4, 7-13, 16 above, and further in view of Liu et al. (CN111549177A; previously cited)(See also the WIPO English translation of CN111549177A; previously cited).
See claims 14, 15 as submitted 2/17/2026.
Applicant contends: Liu et al. does not remedy the deficiencies.
Applicant’s arguments are considered but found unpersuasive.
See the rejection as recited in the previous Office Action.
Response to Arguments
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
The rejection is maintained for reasons of record.
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.
8. (previous rejection, withdrawn as to canceled claim 3; otherwise maintained) Claims 1, 4, 7, 11 are provisionally rejected on the ground of nonstatutory double
patenting as being unpatentable over claims 1-6, 8, 10, 16, 19, 20, 30-32 of copending
Application No. 17/928400 in view of Lee et al. (cited above).
See claims 1, 4, 7, 11 as submitted 2/17/2026.
Applicant contends: the rejection should be held in abeyance until all substantive issues have been addressed.
See the rejection as recited in the previous Office Action.
The rejection is maintained for reasons of record.
Conclusion
9. Claims 5, 6, 17, 18 are objected to for depending on rejected claims. No claims are allowed.
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 M FRANCO G SALVOZA whose telephone number is (571)272-4468. The examiner can normally be reached M-F 8:00 to 5:00.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Thomas Visone can be reached at 571-270-0684. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/M FRANCO G SALVOZA/Primary Examiner, Art Unit 1672
Prosecution Insights