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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 29 July 2025 has been entered.
Drawings
The drawings were received on 15 March 018. These drawings are acceptable.
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, 23, 24, 29, and 30-32 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 16, 17, 19, and 20 of U.S. Patent No. 9,683,259 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because claim 1 of the ‘259 patent is drawn to “a method for detecting a target nucleic acid sequence”. For convenience claim 1 is reproduced below.
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While claims 1, 31, and 32 do not recite the limitation “wherein the target is Neisseria gonorrhoeae, Chun et al., at column 4, in the “BRIEF DESCRIPTION OF THE DRAWINGS”, teaches how each FIG. 7, 8, 9, and 10 “shows the results of the detection of Neisseria gonorrhoeae gene by PCE-SC assay…” In view of such assertions, it would have been most obvious to have designed the claimed method such that the “target nucleic acid sequence” would be that of Neisseria gonorrhoeae.
In view of the above presentation and in the absence of convincing evidence to the contrary, claims 1, 23, 24, and 29-32 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 16, 17, 19, and 20 of U.S. Patent No. 9,683,259 B2.
Claim 1, 23, and 30-32 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 14 and 16 of U.S. Patent No. 9,650,665 B2 (Chun et al.). Although the claims at issue are not identical, they are not patentably distinct from each other because claim 1 of Chun et al., is directed to a method of detecting a nucleic acid sequence via “a PTOEC (PTO Cleavage and Extension) assay”. As set forth in claim 1:
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As evidenced above, claim 1 does not teach using Neisseria gonorrhoeae as the target (limitation of claims 1, 31, and 32); however, as seen in Example 3, at column 63, lines 13-14: “Genomic DNA of Neisseria gonorrhoeae (NG) was used as a target nucleic acid.”
In view of such assertions, it would have been most obvious to design the method for detecting target nucleic acids such that the DNA of Neisseria gonorrhoeae would be detected.
In view of the above presentation and in the absence of convincing evidence to the contrary, claims 1, 23, and 30-32 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 14 and 16 of U.S. Patent No. 9,650,665 B2 (Chun et al.).
Claim Objections
Claims 2, 4-5, 8, 10-11, 13-16, 22, and 26 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
Objections and/or rejections which appeared in the prior Office action and which have not been repeated hereinabove have been withdrawn.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Bradley L. Sisson whose telephone number is (571)272-0751. The examiner can normally be reached Monday to Thursday, from 6:30 AM to 5 PM.
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, Wu-Cheng Shen can be reached at 571-272-3157. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Bradley L. Sisson/Primary Examiner, Art Unit 1682
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