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 .
Status of the Application
The Reply filed November 10, 2025 is acknowledged.
Claims 1-24 and 35 were pending. Claims 1-23 and new claims 37-38 are being examined on the merits. Claims 24 and 35 were withdrawn and are now canceled.
Response to Arguments
Applicant’s arguments filed November 10, 2025 have been fully considered.
The following objections and rejections are WITHDRAWN in view of Applicant’s arguments and claim amendments:
Objections of claims 4, 8 and 13
Rejection of claim 12 under 35 USC § 112(b), indefiniteness
The following rejections are MAINTAINED:
Double patenting
Response to arguments regarding indefiniteness rejections
The Examiner has reconsidered and withdrawn the indefiniteness rejections of claim 12 in view of Applicant’s arguments and the amendment to correct the dependency, and in view of the discussion of the teachings in the instant specification.
Double patenting rejections
Applicant filed a terminal disclaimer on November 10, 2025 to obviate the double-patenting rejections in view of US Patent No. 11,821,028. The terminal disclaimer was determined to be improper for the reasons listed below:
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Thus, the double patenting rejections are maintained.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 37 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 37 depends from claim 1, which recites, in part, performing a ligation reaction
with a first set of complementary double-stranded adapters, where the first set of adapters has at least one mismatch between the first and second strands. Claim 37 then recites a step of performing the ligation reaction of claim 1 step (a) with an additional second adapter or an additional second set of substantially complementary double-stranded adapters, and then using those ligation products with both first set and second set adapters in the claim 1 step (b) amplification reaction. Finally, claim 1 step (b) states that the resulting amplification products “comprise one or more locations that do not form complementary base pairs [i.e., mismatches] in the first and second strands of the substantially complementary double-stranded adapters”. Thus, claim 37 recites at least some embodiments directed to amplification products with one adapter from the first set and one adapter from the second set of substantially complementary double-stranded adapters, but the language in step (b) is unclear as to whether such amplification products have to have mismatches in both the adapter from first set and the adapter from the second set of adapters, or just the adapter from the first set (as in claim 1). To the extent that claim 37 is requiring amplification products with mismatches in the second set of adapters (which would seemingly be required by steps (c) and (d) if sequencing from the second end), it is unclear how and when these mismatches are introduced into the amplicon(s). Since the ordinary artisan would not be able to determine the metes and bounds of the claim, it is indefinite.
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 and 37-38 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. 11,821,028 (hereinafter, “the ‘028 patent").
Although the claims at issue are not identical, they are not patentably distinct from each
other because claim 1 of the ‘028 patent teaches all of the limitations of instant claim 1, albeit in different embodiments.
In addition, claims 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15 and 16 of the ‘028 patent teaches all of the limitations of instant claims 2-4, 5, 6-9, 10, 11, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22 and 23, respectively. In addition, claim 3 of the ‘028 patent teaches all of the limitations of instant claim 37. The ‘028 patent claims do not teach all of the limitations of instant claim 12 or 38, however, customizing the assay to re-arrange primer sequences, and to select assays with particular detection sensitivity or specificity can all be arrived at through routine optimization.
Further, while the instant claims are directed to different embodiments of sequencing methods than the claims of the ‘028 patent, re-arranging the elements to customize assays or create different embodiments can all be arrived at through routine optimization, and thus are obvious based on the limitations of the ‘028 patent claims. In addition, the ordinary artisan would have had an expectation of success in making these modifications as optimizing adapter design is well-known in the art, as is designing and optimizing nucleic acid amplification and sequencing assays.
Conclusion
Claims 1-23 and 37-38 are being examined, and are rejected. No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, 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 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 CAROLYN GREENE whose telephone number is (571)272-3240. The examiner can normally be reached M-Th 7:30-5:30 EST.
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, Gary Benzion can be reached at 571-272-0782. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CAROLYN L GREENE/Primary Examiner, Art Unit 1681
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