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 .
DETAILED ACTION
Status of the Claims
1. Claims 1-199 are the original claims filed on 1/30/2023. In the Preliminary Amendment of 1/2/2024, Claims 16, 51, 54, 90, 93, 129, 132, 135-137, 168, 172, and 183-185 are amended, claims 1-15, 17-50, 52-53, 55-89, 91-92, 94-128, 130-131, 133-134, 138-167, 169-171, 173-182, and 186-199 are canceled and new claims 200-206 are added. In the Response of 12/31/2025, Claims 16, 54, 93, 132, 172, 185, and 203 are amended, claims 51, 90, 129, 135-137, 200-202, and 204 are canceled, and new claims 207-222 are added.
Claims 16, 54, 93, 132, 168, 172, 183-185, 203, and 205-222 are pending and under examination.
The Office Action is final.
Priority
2. USAN 18/018,864, filed 01/30/2023, is a National Stage entry of PCT/US2021/ 044356, International Filing Date: 08/03/2021, PCT/US2021/044356 Claims Priority from Provisional Application 63/061,112, filed 08/04/2020.
Information Disclosure Statement
3. As of 3/9/2026, a total of two (2) IDS are on file: 1/2/2024; and 12/31/2025. The corresponding initialed and dated 1449 form is considered and of record.
Withdrawal of Objections
Specification
4. The objection to the abstract of the disclosure because it contains parenthetical text that renders the abstract indefinite is withdrawn. The amended abstract deletes the parentheses from the text.
5. The objection to the disclosure because of informalities is withdrawn. Both substitute clean and marked-up copies of the specification are filed.
a) The amended specification rectifies the improper use of the term, i.e., Tris, nanobody, BiTE, DART, Alexa, Octet, BiaCORE, Megalign, KinExA, Duobody, Affibody, DARPin, Affilin, Opdivo, Ketruda, Yervoy, Slide-A-Lyzer, Unicorn, Amicon, GenScript, ClarioStar, PathHunter, FloJo, TSKgel, Zenix, which is a trade name or a mark used in commerce.
Withdrawal of Rejections
Claim Rejections – 35 USC § 112(b)
6. The rejection of Claim 172 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite is withdrawn.
Claim 172 is not only amended to delete the term drug, but the entire phrase starting with “optionally” and comprising the term “drug”.
Claim Rejections – 35 USC § 112(a)
Written Description
7. The rejection of Claims 16, 51, 54, 90, 93, 129, 132, 135-137, 168, 172, 183-185, and 200-206 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement is moot for the canceled claims and withdrawn of the pending claims.
Applicants have made a bona fide effort to amend the claims to clarify that the antibodies comprise paired, full length VH and VL domains each comprising CDR1-3.
Written Description
8. The rejection of Claim 185 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement is withdrawn.
Applicants have amended claim 185 to distinguish the method as being therapeutic from prophylactic.
Objections Maintained
Specification
9. The objection to the disclosure because of informalities is maintained
“b)” The figure legends for Figures 1-21 [0017-0037] are objected to for failing to provide any detail of the sample and control antibodies that are shown for those data depicted in the corresponding figure. The legends are bereft of any explanation. 37 CFR 184(o) Legends. Suitable descriptive legends may be used subject to approval by the Office, or may be required by the examiner where necessary for understanding of the drawing.
Applicants allege the details of the sample and control antibodies for Figures 1-21 are already provided in the figures themselves, and thus the figures together with their associated descriptions provide sufficient information about the depicted data.
Response to Arguments
The figures legends are bereft of explanation of/for labels and insets. For example, Figure 1 contains an inset for a single antibody CP40xP24 EC50 value and makes no correlation with the Log M vs RFU indices. The figure legend does not explain the meaning of “secondary only” compared to what is a control antibody versus a sample antibody.
The objection is maintained.
Claim Objections
10. The objections to Claims
Applicants allege claim 16 is amended to recite that “the heavy chain CDRs and the light chain CDRs of the first binding domain and the heavy chain CDRs and the light chain CDRs of the second binding domain are determined according to Kabat numbering system, Chothia numbering system, AbM numbering system, Contact numbering system, IMGT numbering system, or Exemplary numbering system.
Response to Arguments
Applicants have not included the corresponding numbering system in any of the original pending claims much less the new claims in the Response of 12/31/2025.
For example, Applicants provide no explanation what VHCDR1-3 and VLCDR1-3 are from any one of the clones C40, C56, C59, P22, P24 and P31.2 (see Claim 16) much less the numbering system (see insertion of final “wherein” clause in Claim 16) to which the respective VHCDR1-3 and VLCDR1-3 correspond to in Claims 54(i)-(vi); 93(i)-(vi); 132(i)-(vi); 207 (i)-(vi); 208 (i)-(vi); 209 (i)-(vi); 210 (i)-(vi); 211 (i)-(vi); and 212 (i)-(vi). Amending the claims to clarify the numbering systems for each of the claims and the corresponding clones would not change the meaning or scope of the claims.
The objection is maintained.
Rejections Maintained
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€ 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.
11. The provisional rejection of Claims 20230357391) is maintained.
Applicants request that the provisional rejection is held in abeyance is granted.
The provisional rejection is maintained.
12. The provisional rejection of Claims 20230303699) is maintained.
Applicants request that the provisional rejection is held in abeyance is granted.
The provisional rejection is maintained.
Conclusion
13. No claims are allowed.
14. 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.
15. Any inquiry concerning this communication or earlier communications from the examiner should be directed to LYNN A. BRISTOL whose telephone number is (571)272-6883. The examiner can normally be reached Mon-Fri 9 AM-5 PM.
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LYNN ANNE BRISTOL
Primary Examiner
Art Unit 1643
/LYNN A BRISTOL/Primary Examiner, Art Unit 1643