DETAILED ACTION
Response to Amendment
Applicant’s response to the office action filed on April 17, 2026 has been entered. The claims pending in this application are claims 1, 5-8, 10-19, 21, and 22 wherein claims 15 and 19 have been withdrawn due to the restriction requirement mailed on August 24, 2024. The Objections and rejections not reiterated from the previous office action are hereby withdrawn in view of applicant’s amendment filed on April 17, 2026. Claims 1, 5-8, 10-14, 16-18, 21, and 22 will be examined.
Specification
The amendment in the specification filed on April 17, 2026 has been accepted and entered by the office.
Claim Objections
Claim 13 is objected to because of the following informality: “second label” should be “label”.
Claim 17 is objected to because of the following informality: “is other than” should be “does not comprise”.
Appropriate correction is required.
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.
Claims 1, 3-8, 10-14, and 16-18 are 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 1 is rejected as vague and indefinite. Since claim 1 does not require that each of the first oligonucleotide probes in the first probe set has an identical length, it is unclear why
the at least one first hapten in each of the first oligonucleotide probes in the first probe set can be positioned at a substantially identical position. Please clarify.
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 21 and 22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 11,421,266 B2 in view of Van Der Wijk et al., (US 2009/0117670 A1, priority date: April 27, 2007).
Claims 1 and 4 of U.S. Patent No. 11,421,266 B2 teaches all imitations recited in claims 21 and 22 except a first anti-hapten antibody specific to the 2,4-dinitrophenyl hapten as recited in claim 21.
Van Der Wijk et al., teach antibodies against 2,4-dinitrophenyl (DNP) (see paragraph [0058]).
Therefore, it would have been prima facie obvious to one having ordinary skill in the art at the time the invention was made to have made the kit recited in claim 21 comprising a first anti-hapten antibody specific to the 2,4-dinitrophenyl hapten in view of the prior arts of claims 1-19 of U.S. Patent No. 11,421,266 B2 and Van Der Wijk et al.. One having ordinary skill in the art would have been motivated to do so because Van Der Wijk et al., teach antibodies against 2,4-dinitrophenyl (DNP) (see paragraph [0058]). One having ordinary skill in the art at the time the invention was made would have a reasonable expectation of success to make the kit as recited in claim 21 by adding antibodies against 2,4-dinitrophenyl (DNP) taught by Van Der Wijk et al., into the kits of claims 1 and 4 of U.S. Patent No. 11,421,266 B2 in order to detect 2,4-dinitrophenyl hapten in the first probe set.
Response to Arguments
Applicant’s arguments with respect to claims 1, 5-8, 10-14, 16-18, 21, and 22 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
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.
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Frank Lu, Ph. D., whose telephone number is (571)272-0746. The examiner can normally be reached Monday to Friday, 9 AM to 5 PM.
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/FRANK W LU/
Primary Examiner, Art Unit 1683
September 18, 2026
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