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 .
Please Note: the Examiner handling this application has changed and is now Stephen Kapushoc in art unit 1683.
This Office Action is in reply to Applicants’ correspondence of 03/13/2026.
Applicants’ remarks and amendments have been fully and carefully considered but are not found to be sufficient to put the application in condition for allowance. Any new grounds of rejection presented in this Office Action are necessitated by Applicants’ amendments. Any rejections or objections not reiterated herein have been withdrawn in light of the amendments to the claims or as discussed in this Office Action.
This Action is made FINAL.
Please Note: The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Withdrawn Claim Rejections - 35 USC § 101
The rejection of claims under 35 USC 101, as set forth on pages 2-4 of the Office Action of 11/16/2025, is withdrawn in light of the amendments to the claims.
Withdrawn Claim Rejections - 35 USC § 112 - Indefiniteness
The rejections of claims under 35 USC 112, as set forth on page 5 of the Office Action of 11/16/2025, are withdrawn in light of the amendments to the claims.
Withdrawn Claim Rejections - 35 USC § 103
The rejections of claims under 35 USC 103, as set forth on pages 6-9 of the Office Action of 11/16/2025, are withdrawn in light of the amendments to the claims.
New Claim Rejection - Double Patenting
The instant application is filed as a divisional (DIV) of parent application 16/344,413 (issued as US Patent 11,390,911). Application 16/344,413 included a lack of unity restriction requirement (03/24/2021) providing two groups of inventions:
Group I –methods of detecting a nucleic acid molecule; and
Group II – directed to methods of designing a detection probe and a competitive probe.
During prosecution of the 16/344,413 application the claims of elected Group I were amended to include steps of “designing” a detection probe and a competitive probe (see amended claims of 11/11/2021), and the allowed claims of US Patent 11,390,911 are directed to methods that include the combination of detecting and designing. As such the methods of the allowed claims are not the same as the claims of Group I as addressed in the lack of unity restriction requirement (03/24/2021).
The claims of 03/13/2026 the instant application have been amended such that the original claims of the DIV application (directed to methods of designing) now include steps of detecting. Where the claims of the DIV application are no longer directed to the same subject matter that was addressed in the lack of unity restriction requirement, and the claims of the instant application are directed to methods that are not distinct form the methods of the allowed claims, consideration of double patenting is appropriate.
MPEP 804.01 addresses situation where a prohibition of nonstatutory double patenting rejections under 35 U.S.C. 121 is, and is not, provided. Relevant to the instant rejection of claims the MPEP provides:
The following are situations where the prohibition against nonstatutory double patenting rejections under 35 U.S.C. 121 does not apply:
(B) The claims of the application under examination and claims of the other application/patent are not consonant with the restriction requirement made by the examiner, since the claims have been changed in material respects from the claims at the time the requirement was made. For example, the divisional application filed includes additional claims not consonant in scope with the original claims subject to restriction in the parent. Symbol Technologies, Inc. v. Opticon, Inc., 935 F.2d 1569, 19 USPQ2d 1241 (Fed. Cir. 1991); Gerber Garment Technology, Inc. v. Lectra Systems, Inc., 916 F.2d 683, 16 USPQ2d 1436 (Fed. Cir. 1990). In order for consonance to exist, the line of demarcation between the independent and distinct inventions identified by the examiner in the requirement for restriction must be maintained. 916 F.2d at 688, 16 USPQ2d at 1440.
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 1-10 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of U.S. Patent No. 11,390,911. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the conflicting patent are directed to methods requiring detecting a target base sequence in a nucleic acid using a fluorescent probe s and a competitive probe, including designing the probes; the instantly rejected claims set forth steps of designing probes and then detecting a target nucleic acid with the probes.
Claims 11-120 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of U.S. Patent No. 11,390,911 in view of Kovaliov et al (2014).
The claims of the conflicting patent are directed to methods requiring detecting a target base sequence in a nucleic acid using a fluorescent probe and a competitive probe, including designing the probes; the instantly rejected claims set forth steps of designing probes and then detecting a target nucleic acid with the probes.
The conflicting claims do not specially recite synthesizing the probes and labeling a probe with a fluorescent dye. However the conflicting claims set forth designing probes, and detecting targets using the probes, including a fluorescently labeled probe; and the synthesis of nucleic acid probes including labeling of probes with fluorescent dyes was known in the prior art and is taught by Kovaliov et al.
It would have been obvious to someone with ordinary skill in the relevant art to have synthesized the probes required by the conflicting claims. The skilled artisan would have been motivated to synthesize the probes based on the requirements of the conflicting claims that probes are used to detect a target. The skilled artisan would have had a reasonable expectation of success because Kovaliov et al exemplifies the synthesis of nucleic acid probes with specific sequences, and the labeling of probes with fluorescent dyes that are suitable for use in a quenching probe/primer method.
Conclusion
No claim is allowed.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Lyon (2001) teaches methods related to the detection of mutations using melting curve analysis, including aspects of designing probes for hybridization assays (e.g.: p.94 - Hybridization probe design).
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 STEPHEN THOMAS KAPUSHOC whose telephone number is (571)272-3312. The examiner can normally be reached M-F, 8am-5pm.
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, Anne Gussow can be reached at 571-272-6047. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Stephen Kapushoc
Primary Examiner
Art Unit 1683
/STEPHEN T KAPUSHOC/Primary Examiner, Art Unit 1683
