Notice of Pre-AIA or AIA Status
1. The present application is being examined under the pre-AIA first to invent provisions.
Specification
2. The disclosure is objected to because of the following informalities: Paragraph [0041] recites the term “USB.” This is believed to be a typographical error and the term should read “UBA”.
Appropriate correction is required.
Election/Restrictions
3. Applicant's election with traverse of Group III, claims 101-107 in the reply filed on 05 November 2025 is acknowledged. The traversal is on the ground(s) that there would be no undue burden in searching all the claims together. This is not found persuasive because each independent claim, as evidenced by their different classifications, are broad enough so as to require independent searches for each separate invention.
The requirement is still deemed proper and is therefore made FINAL.
Claim Rejections - 35 USC § 112
4. 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.
5. Claims 101, 112 and 113 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.
A. Claim 101 recites the terms “UBS” and “USB” which are not defined in the claim. The term “USB” appears in the specification ([0041]), but the specification provides no detail as to the structure of this term. UBS does not appear in the specification, and as such these terms lack clarity on how they impact the metes and bounds of the claim and therefore the claim is indefinite. Additionally, step (b) of claim 1 recites the phrase “detecting the amount of labeled ESBs bound to the target via the UBAs…” The phrase “the UBAs” lacks proper antecedent basis in the preceding phrase “a mixture of labeled and unlabeled unique binding agents (UBAs)” because it is unclear which UBA (labeled or unlabeled) this limitation refers to. The phrase “labeled ESBs” further lacks clarity, because applicant’s specification indicates that “unlabeled ESB include the UBA, but the sequence is not readily amplifiable in downstream steps…” ([00334]). It is therefore unclear if this claim intends to encompass embodiments wherein the population of labeled UBAs include labeled and unlabeled ESBs in a fashion that would further adjust the “predetermined ratio.” For the reasons outlined above, this claim is indefinite.
B. All claims not directly mentioned about are rejected for being dependent on a previously rejected claim.
Double Patenting
6. 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.
7. Claims 101, 112 and 113 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of U.S. Patent No. 10174310 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are drawn to the contacting of cells, UBAs, labeled and unlabeled ESBs, and performing spilt pool synthesis on cells.
Claims 1 and 3 of the issued patent teach a method that has all the steps of instant claim 101.
This issued claims to not teach a method that includes all of the limitations of instant claim 101 in a single claim. However, it would have been prima facie obvious to one having ordinary skill in the art to have modified any one of the issued claims with the limitation wherein the amount of a target is quantified by multiplying the detected amount by the ratio of labeled and unlabeled UBAs in the UBA mixture to arrive at the instantly claimed invention with a reasonable expectation of success.
The limitations of instant claim 112 and 113 are taught in claims 1 and 6 of the issued patent.
8. Claims 101, 112 and 113 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of U.S. Patent No. 11214794 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are drawn to the contacting of cells, UBAs, labeled and unlabeled ESBs, and performing spilt pool synthesis on cells.
Claims 1 and 3 of the issued patent teach all the limitations of instant claim 101.
This issued claims to not teach a method that includes all of the limitations of instant claim 101 in a single claim. However, it would have been prima facie obvious to one having ordinary skill in the art to have modified any one of the issued claims with the limitation wherein the amount of a target is quantified by multiplying the detected amount by the ratio of labeled and unlabeled UBAs in the UBA mixture to arrive at the instantly claimed invention with a reasonable expectation of success.
The limitations of claims 112 and 113 are taught in claims 1 and 6 of the issued patent.
Response to Arguments
9. The rejections under U.S.C. 112, second paragraph in the Office Action filed 09 January 2026 were overcome by amendment of claim 101 and cancelation of claims 102-107. However amendments to claim 101 have necessitated new rejections under U.S.C. 112, second paragraph.
Regarding the double patenting rejections, the response requests that the Examiner hold the provisional rejection in abeyance until otherwise allowable subject matter is identified in the instant application. However, a complete response to a nonstatutory double patenting (NSDP) rejection is either a reply by applicant showing that the claims subject to the rejection are patentably distinct from the reference claims or the filing of a terminal disclaimer in accordance with 37 CFR 1.321 in the pending application(s) with a reply to the Office action (see MPEP § 1490 for a discussion of terminal disclaimers). Such a response is required even when the nonstatutory double patenting rejection is provisional. As filing a terminal disclaimer, or filing a showing that the claims subject to the rejection are patentably distinct from the reference application’s claims, is necessary for further consideration of the rejection of the claims, such a filing should not be held in abeyance. MPEP §804(I)(b)(1). Therefore, for the reasons set forth above and those already of record, the provisional nonstatutory double patenting rejection is modified to address the amended claims, and maintained.
10. THIS ACTION IS MADE FINAL. 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.
Conclusion
11. No claims are allowed.
12. Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIAN ELLIS YOUNG whose telephone number is (703)756-5397. The examiner can normally be reached M-T 0800 - 1630.
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, Heather Calamita can be reached at (571) 272-2876. 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.
/BRIAN ELLIS YOUNG/Examiner, Art Unit 1684 /HEATHER CALAMITA/Supervisory Patent Examiner, Art Unit 1684
Prosecution Insights