DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
2. Applicant’s election with traverse of Group III (claims 18-23) in the reply filed on 2/3/2026 is acknowledged. The traversal is based on applicant’s assertion that “examination of all pending claims is possible without imposing and undue search burden on the Office.” This is not found persuasive because search and examination of 4 patentably distinct inventions (i.e., Groups I-IV) would constitute a serious burden. Thus, the requirement is still deemed proper and is therefore made FINAL.
3. Claims 1-30 are pending in the application. Claims 10-17 and 24-30 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Claims 18-23 are currently under examination.
Double Patenting
4. 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.
5. Claims 18-23 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of U.S. Patent No. 11,371,088. Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1-9 of U.S. Patent No. 11,371,088 teach or render obvious all the steps and elements as recited in instant claims 18-23. Specifically, claims 1-3 of U.S. Patent No. 11,371,088 teach all the steps and elements recited in instant claim 18. In addition, the other features as recited in instant claims 19-23 are also taught or rendered obvious by claims 1-9 of U.S. Patent No. 11,371,088.
Claim Rejections - 35 USC § 102
6. In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
7. The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
8. Claims 18-20 and 22-23 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Uemori et al. (WO 2016/039377 A1, using the published U.S. national stage application, US 2017/0253909 A1, as an English translation).
Regarding claim 18
Uemori et al. teach, throughout the whole document, a method for identifying a mismatched nucleotide in a double-stranded nucleic acid, comprising: (a) reacting a sample comprising the double-stranded nucleic acid with EndoMS (i.e., NucS or mismatch-specific endonuclease. See the term “EndoMS” as defined in the paragraph spanning pages 5-6 of the specification as filed) to produce a reaction product, wherein the EndoMS cleaves both strands of the double-stranded nucleic acid only if it contains a mismatch (see paragraphs [0091]-[0092] and [0098], where the “mismatch endonuclease” used is NucS as described in paragraph [0025] and Examples 1-6); (b) subjecting the reaction product of (a) to amplification under conditions that amplify the double-stranded nucleic acid if it is uncleaved but not if it is cleaved (see paragraphs [0091]-[0092] and [0098]); and (c) detecting the presence of an amplification product, wherein the presence of the product indicates that the double-stranded nucleic acid does not have a mismatched nucleotide and the absence of a product indicates that the double-stranded nucleic acid has a mismatched nucleotide (see paragraph [0106]).
Regarding claim 19
The method according to Uemori et al., wherein step (b) is done by PCR, using primers that flank the mismatch (see paragraphs [0091]-[0093]).
Regarding claim 20
The method according to Uemori et al., wherein mismatch is at a ligation junction (see paragraphs [0091]-[0092] and [0098]. Since the mismatch site is in the internal portion of the double-stranded nucleic acid, such site can be a hypothetical ligation junction (if the double-stranded nucleic acid were to be generated by the ligation of the two corresponding fragments flanking the ligation junction) because any such site can be a hypothetical ligation junction.).
Regarding claim 22
The method according to Uemori et al., wherein the double-stranded nucleic acid is genomic DNA (see paragraph [0105]).
Regarding claim 23
The method according to Uemori et al., wherein the detecting step (c) comprises quantifying the amount of the amplification product (see paragraph [0111]).
Conclusion
9. No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KAIJIANG ZHANG whose telephone number is (571)272-5207. The examiner can normally be reached Monday - Friday, 8:30 am - 5 pm.
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/KAIJIANG ZHANG/Primary Examiner, Art Unit 1684