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 1-5 are the original claims filed on 6/18/2025. IN the Response of 10/29/2025, claims 1, 3 and 5 are amended. In the Response of 3/13/2026, claims 1 and 5 are amended and new claims 6-30 are added. In the Response of 7/1/2026, claims 1, 3, 5, 11, 13, 18, 20, 21, 23, and 25 are amended, claims 2, 6-10, 12, 15, 17, 19, 22, 24, 27, and 29 are canceled and new claims 31-32 are added.
Claims 1, 3-5, 11, 13-14, 16, 18, 20-21, 23, 25-26, 28, and 30-32 are pending.
Applicants amendment of the claims raises new grounds for rejection. The Office Action is final.
Priority
2. USAN 19/242,715, filed 06/18/2025, and having 1 RCE-type filing therein, is a Continuation of 18/150,514, filed 01/05/2023, now U.S. Patent # 12404335, 18/150,514 is a Continuation of 17/822,978, filed 08/29/2022, now U.S. Patent # 11548951, 17/822,978 is a Continuation of 17/501,362, filed 10/14/2021, now abandoned, 17/501,362 Claims Priority from Provisional Application 63/261,742, filed 09/28/2021, 17/501,362 Claims Priority from Provisional Application 63/260,130, filed 08/10/2021, 17/501,362 Claims Priority from Provisional Application 63/201,978, filed 05/21/2021, 17/501,362 Claims Priority from Provisional Application 63/091,839, filed 10/14/2020.
Information Disclosure Statement
3. As of 7/13/2026, a total of four (4) IDS are filed for this application: 10/6/2025; 10/10/2025; 3/13/2026; and 7/1/2026. The corresponding initialed and dated 1449 form is considered and of record.
Withdrawal of Rejections
Claim Rejections - 35 USC § 103
4. The rejection of Claim(s) 1-2 and 4-5 under 35 U.S.C. 103 as being unpatentable over Guelberto et al (Oncogene 28(34):3008-3021(8/27/2009)) in view of Hartmann et al (US US 20160159894-A1) as evidenced by Burak (US 20220088231) is moot for the canceled claims and withdrawn for the pending claims.
The increased binding affinity for IGF-1R in combination with increased serum half-life and an IC50 of from 0.4 nm to 0.09 nM for the VRDN-001 VH/VL in the antibody format with a YTE Fc region is an unexpected improvement. See the Bedian Declaration filed 7/1/2026 in the IDS.
5. The rejection of Claim(s) 1-2, 4-5, 7-10, 14-20, and 26-30 under 35 U.S.C. 103 as being unpatentable over Sherman et al. (US 20210253719, published 19 August 2021, filed 3 March 2021 and corresponding to Sherman et al. (WO 2021/041773, published 04 March 2021, filed 28 August 2020; IDS 10/6/2025) as evidenced by Burak et al. (U.S. Patent No. 10,093,741; IDS 10/6/2025) and in view of HARTMANN et al (AU 2019200635; published 2019-02-21) as evidenced by Viridian (News Release VRDN-003, pp. 1-4 (6/11/2024)) is moot for the canceled claims and withdrawn for the pending claims.
The increased binding affinity for IGF-1R in combination with increased serum half-life and an IC50 of from 0.4 nm to 0.09 nM for the VRDN-001 VH/VL in the antibody format with a YTE Fc region is an unexpected improvement. See the Bedian Declaration filed 7/1/2026 in the IDS.
Claim Rejections - 35 USC § 112(a)
Written Description
6. The rejection of Claims 3, 6, 11-13, and 21-25 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 for the pending claims. Claims 1 and 5 are amended to include the antigen for the antibody and pharmaceutical composition comprising the antibody.
Claims 3, 11 and 13 are amended to recite a range for the IC50 of the antibody.
Double Patenting
7. The rejection of Claims 12600788 B2 is withdrawn. The terminal disclaimer filed on 7/1/2026 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of US 12600788 has been reviewed and is accepted. The terminal disclaimer has been recorded.
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.
8. The rejection of Claims
Applicants allege that in view of Baurin and Mates, the outstanding NSDP rejection is improper for the ref patent having a later patent term filing date and expiration date.
Response to Arguments
(A) Compare the continuity map between the ref patent and the instant application that share identical priority dates for provisional applications:
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Ex Parte Baurin, Appeal 2024-002920, is not precedential. Even assuming, arguendo, Baurin has no precedential value to the facts nor the claims in the instant case. Ex parte Mates, Appeal 2025-001500, is not precedential. Even assuming, arguendo, Mates has no precedential value to the facts nor the claims in the instant case.
(B) The legal framework that governs a nonstatutory double patenting rejection on the merits is set forth in Graham v. John Deere Co. of Kansas City. Applicants do not dispute the technical similarity between the ref patent claims and the instant claims.
(C) The patent term is only one of two reasons why the Office requires filing a TD.
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”).
ii) One patent to each invention per inventor
TDs are 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.
New Grounds for Rejection
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.
9. Claims 11,13-14 and 16 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.
-) Claims 11, 13-14 and 16 are indefinite for depending from canceled claims 8 (claims 11 and 14) and 10 (Claims 13 and 16). The POSA cannot reasonably ascertain the full metes and bounds of the inventive subject matter. MPEP 608.01(m).
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.
10. Claims 1, 3-5, 11, 13-14, 16, 18, 20-21, 23, 25-26, 28, and 30-32 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 50-71 of copending Application No. 19/287,281 (PTO 892 in view of claims 1-18 of U.S. Patent No. US 12600788 B2 (PTO 892). The reference application and ref patent that share continuity are not afforded safe harbor under 35 USC 121 because neither shares continuity/ restriction/ speciation with the claims of the instant application.
Claims 50-71 of ‘281 drawn to the method of treating TED with the anti-IGF-R1 antibody comprising a dose regimen absent a showing of unexpected results in view of the method of treating TED with the anti-IGF-R1 antibody comprising the Fc region comprising M252Y, S254T, and T256E substitutions wherein numbering is according to the Kabat numbering system of ‘788 renders the instant product anti-IGF-1R claims obvious that encompass the same antibody used in each of the method inventions.
This is a provisional nonstatutory double patenting rejection.
Conclusion
11. No claims are allowed.
12. 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.
13. 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 on 571-272-5205. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LYNN A BRISTOL/Primary Examiner, Art Unit 1643
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