DETAILED ACTION
The amendment and RCE filed on 02/09/2026 has been entered and fully considered. Claims 33-37 and 39-41 are pending. Claims 33-35 and 39 have been withdrawn from consideration. Claims 36-37 and 40-41 are considered on merits, of which claim 36 is amended.
Response to Amendment
In response to amendment, the examiner establishes new 112b rejection and maintains obvious double patenting established in the previous Office 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 .
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.
Claim 36-37 and 40-41 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-26 and 29-32 of copending Application No. 17/399,417 (reference application) and claim 33-35 and 38-44 of copending Application No. 17/862,990 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because both the instant claims and the currently patented claims expressly recite the same subject matter, it would have been obvious to one of ordinary skill in the art at the time the invention was made to employ both device and methods, as recited in both sets of claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
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 36-37 and 40-41 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 36 recites the limitation "said plurality mass-tags" in line 11. There is insufficient antecedent basis for this limitation in the claim.
Response to Arguments
Applicant's arguments filed 02/09/2026 have been fully considered but they are not persuasive.
Nonstatutory Obviousness-Type Double Patenting Rejection
Applicant argues that the claims of copending Application No. 17/399,417 and Application No. 17/862,990 do not call out multiple mass-tags on the same probe molecule and do not specify 5′ and 3′ ends, and therefore the present claims are patentably distinct.
This argument is not persuasive.
1. ODP does NOT require identical disclosure
Nonstatutory double patenting is concerned with patentably indistinct subject matter, not whether the claims are worded identically.
The proper inquiry is whether the present claims are an obvious variation of the reference claims. See MPEP §804(I)(B)(1).
Even if the reference claims do not explicitly recite identical structural language, the rejection is proper if the differences would have been obvious.
2. Reference claims already disclose probes with mass-tags
The claims of Application No. 17/399,417 and Application No. 17/862,990 recite nucleic acid probes comprising:
target binding regions, and
attached mass-tags.
The present claim 36 recites the same fundamental structure:
nucleic acid probe molecule
target binding region
mass-tags attached to probe
use for detection via mass spectrometry
These core structural and functional elements are shared.
3. Reciting multiple tags is an obvious variation
Applicant argues the reference claims do not recite multiple mass-tags.
However, modifying a probe to include multiple detectable tags instead of one would have been an obvious variation because:
Increasing signal strength using multiple labels is a well-known and routine optimization.
It merely represents duplication of known elements performing the same function.
Such duplication is considered an obvious variation.
See MPEP §806.05(j) and In re Harza, 274 F.2d 669 (CCPA 1960).
Thus, reciting multiple mass-tags does not render the claim patentably distinct.
4. Reciting 5′ and 3′ ends does not confer patentable distinction
Applicant also argues that the present claims recite specific 5′ and 3′ ends.
However, nucleic acid probes inherently possess 5′ and 3′ ends.
Specifying the location of known probe elements relative to inherent structural termini would have been obvious to a person of ordinary skill in the art.
Such structural orientation does not create patentable distinction where the underlying probe structure remains the same.
5. The claims are directed to the same inventive concept
Both the present claims and the reference claims are directed to:
nucleic acid probes comprising mass-tags
binding to target nucleic acids
detection using mass spectrometry
The present claims represent an obvious variation of the same inventive concept.
Allowing both would result in an improper extension of patent rights.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to XIAOYUN R XU, Ph. D. whose telephone number is (571)270-5560. 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, Lyle Alexander can be reached at 571-272-1254. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/XIAOYUN R XU, Ph.D./Primary Examiner, Art Unit 1797