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
Continued Examination Under 37 CFR 1.114
1. A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 3/31/2026 has been entered.
Status of the Claims
2. Claims 1-32 are the original claims filed on 3/11/2022. In the Response of 12/9/2025, claims 11-12, 14-21, 23, 25, 28-29, and 31-32 are amended, claims 1-10, 13, and 30 are canceled, and new claims 33-34 are added. In the Response of 3/31/2026, claims 11, 15, 29, and 31-32 are amended.
Claims 11-12, 14-29, and 31-34 are pending.
Priority
3. USAN 17/692,979, filed 03/11/2022, and having 1 RCE-type filing therein, is a Continuation of PCT/US2020/050380, filed 09/11/2020, PCT/US2020/050380 Claims Priority from Provisional Application 62/936,913, filed 11/18/2019, PCT/US2020/ 050380 Claims Priority from Provisional Application 62/900,118, filed 09/13/2019.
Information Disclosure Statement
4. As of 5/10/2026, a total of seven (7) IDS are filed: 6/15/2023; 9/14/2023; 9/25/2023; 12/4/2023; 2/13/2024; 3/7/2025; and 9/5/2025. The corresponding initialed and dated 1449 form is considered and of record. The submissions are in compliance with the provisions of 37 CFR 1.97.
Withdrawal of Objection(s)
Claim Objections
5. The objections to Claims 11-12, 14-29, and 31-34 because of informalities is withdrawn. Claim 11 is amended to recite “An anti-CD371 antibody or an antigen-binding fragment thereof, comprising a heavy chain variable region that comprises CDR1, CDR2, and CDR3 domains; and a light chain variable region that comprises CDR1, CDR2, and CDR3 domains.”
Withdrawal of Rejections
Claim Rejections - 35 USC § 112(b)
6. The rejections Claims 1-2, 8, 12-15, and 17-32 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite is withdrawn. Claim 15 is amended to delete the term “about.”
Claim Rejections - 35 USC § 112(a)
Written Description
7. The rejection of Claims 11-12, 14-29, and 31-34 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. The claims are amended to delete the term “about” and to include the sequences for the cell-assay based performative antibody clones, B10 and C3.
Enablement
8. The rejection of Claims 29-32 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement is withdrawn. The claims are amended to recite the disclosed species clones B10 (Table 1; SEQ ID NOS: 1 and 2) and C3 (Table 2; SEQ ID NOS: 3 and 4) that are tested, in vitro, for cell binding (Example 2). In Example 3, B10 was tested for soluble binding to CD371.
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(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.
9. The provisional rejection of Claims 11-12, 14-29, and 31-34 on the ground of nonstatutory double patenting as being unpatentable over claims 1-3 and 7-37 of copending Application No. 17/693,060 (reference application US 20220213211) is maintained.
Applicants allege the facts of Ex Parte Baurin make it unapplicable to the instant case, the passage cited by the Examiner expressly highlights that PTAB considered Allergan, which relates to cases sharing priority dates, as relevant to cases where the cited case was subsequently filed (as in Ex Parte Baurin). Applicants note that, the PTAB's interpretation of the impact of the Federal Circuit's decision in Allergan was recently reemphasized in its Denial of Rehearing in Ex Parte Baurin, Appeal 2024-002920, Appl. No. 17/135,529 (December 18, 2025), underscoring the inappropriateness of using an application with a common filing date and expected expiration date as a reference application in an obviousness type double patenting rejection.
Response to Arguments
A) To restate Applicants assertion of the Allergen decision as “compelling” is inappropriate and irrelevant to the facts considered under Baurin, the decision relied on by Applicants as originally presented in the Response of 12/9/2025:
“The Board acknowledged Allergan involved patents with a shared priority date in contrast to the Baurin facts involving different priority dates. Still, the Board found the Allergan “reasoning compelling”, concluding that the earlier-filed, earlier-expiring ’529 application is the “first patent” and “not a second, later expiring patent for the same invention.”” [Examiner’s italics]
“compel” (Black’s Law Dictionary Black's Law Dictionary (12th ed. 2024): “Of a legislative mandate or judicial precedent) to convince (a court) that there is only one possible resolution of a legal dispute <the wording of the statute compels us to affirm>.
Applicants will need to establish that Allergan is precedential for the record.
B) To repeat and re-iterate that Ex Parte Baurin is not a precedential decision, and even assuming, arguendo, Baurin has no bearing or relevance to the facts nor the claims in the instant case.
C) Applicants are silent on the record that Claims 11-12, 14-29, and 31-34 are patentably distinct from Claims 1-3 and 7-37 of copending Application No. 17/693,060.
D) The patent term is only one of two reasons why the Office requires filing a Terminal Disclaimer.
i) Patent term
If more than one patent could be obtained on the same invention, an inventor could extend the period of exclusivity beyond what the law intends (See In re Goodman, 11 F3d. 1046, 1053 (Fed. Cir. 1993); General Foods Corp v. Studiengesellschaft Kohle MbH, 972 F.2d 1271, 1279-80 (Fed. Cir. 1992) (“The basic concept of double patenting is that the same invention cannot be patented more than once, which, if happened, would result in a second patent which would expire sometime after the original patent and extend the protection timewise”). For example, an inventor could apply for one patent in 2005 and a second on the same invention in 2015, thereby obtaining the equivalent of a 30-year patent.
ii) One patent to each invention per inventor
A Terminal Disclaimer is also required to link two cases together so that two patents to the same or a similar invention cannot be sold separately. An inventor is entitled to one patent on one invention (see In re Leonardo, 119 F.3d 960, 965 (Fed. Cir. 1997).
The double patenting rejection may be obviated by filing a terminal disclaimer in accordance with 37 CFR 1.321(d). See MPEP § 804 and § 804.02. The rejection is maintained.
The rejection is maintained.
Conclusion
10. No claims are allowed.
11. 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.
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, Wu Julie can be reached at 571-272-5205. 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.
/LYNN A BRISTOL/Primary Examiner, Art Unit 1643
Prosecution Insights