DETAILED 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 .
Priority
Acknowledgement is made of the applicant’s claim for foreign priority based on the application filed on 12 March 2021. The effective filing date is 12 March 2021.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 01 May 2024 and 23 July 2026 have been considered by the examiner.
Status of Application, Amendments, and/or Claims
Claims 1-6, 9, 11-13, 16-22, 24-34, and 37 were the subject of the 20 April 2026 office action. In the amendment of 23 July 2026, claims 2 was cancelled, claims 1, 3, 16, 29, and 37 were amended, and claims 40-43 were added. Claims 1, 3-6, 9, 11-13, 16-22, 24-34, and 40-43 are pending and the subject of this office action.
Withdrawn Objections/Rejections
Claims 3, 16, 29, and 37 were previously rejected under 35 U.S.C. 112(b), but have been amended to no longer include preferred limitations, and as a result the rejections have been withdrawn.
Claims 1, 3-4, 9, 11-13, 17, and 29-34 were previously rejected under 35 U.S.C. 102(a)(1) and (a)(2), as being anticipated by US20170073421. The claims have been amended to include limitations from claim 2, which has been removed from the current claim set, and as a result the rejections have been withdrawn.
Claim 2 was previously rejected under 35 U.S.C. 103 as being unpatentable over US20170073421 (herein Kjaergaard) in view of Rowley TF, et al. (2018) Engineered hexavalent Fc proteins with enhanced Fc-gamma receptor avidity provide insights into immune-complex interactions. Commun Biol. 2018 Sep 14;1:146 (herein Rowley). The claim has been cancelled, rendering the rejection moot, but the limitations have been incorporated into claim 1. The applicant’s arguments regarding the combination of prior art, previously used as grounds for the rejection of claim 2, were found to be compelling and the examiner has conceded that the previous rejection of claim 2 was improper, and as such may not be applied to the amended claim 1, which now includes the limitations of the previous claim 2. In short, the applicant argued that there was insufficient teachings, suggestions, or motivation to combine the L234F mutant, taught by Rowley, with the L234A+L235E+G236R IgG1 mutant taught Kjaergaard, as Kjaergaard identifies several IgG mutants, comprising different amino acid substitutions, that exhibit superior biological efficacy compared to the L234A+L235E+G236R IgG1 mutant. Thus, it would not have been obvious to select the L234A+L235E+G236R or to combine this mutant.
Claims 3, 6, 18-22, 26-28, and 37 were previously subjected to 35 U.S.C. 103 rejections, reliant on the prior art discussed above. Since the applicant’s arguments countering the previous rejection were found to be compelling, the 35 U.S.C. 103 rejections of claims 3, 6, 18-22, 26-28, and 37 have been withdrawn.
Claims 1-6, 9, 11-13, 16-22, 24-34, and 37 were previously rejected on grounds of non-statutory double patenting over. Claim 2 has been cancelled rendering any related rejections moot. The applicant has chosen not to address the remaining rejections, until there is indication of otherwise allowable subject matter. Therefore, the previous double patenting rejections remain.
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.
Claims 1, 3-6, 9, 11-13, 16-22, 26, and 37 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 9-11 of U.S. Patent No. 12351650 (herein ‘650). Although the claims at issue are not identical, they are not patentably distinct from each other, because the invention disclosed in ‘650 encompasses the invention disclosed in the current application, as explained below.
Claims 9-11 of ‘650 all refer to an anti-FAPα/DR4 bispecific antibody wherein at least one IgG1 heavy chain has amino acid substitutions corresponding to L234F, L235E, and G236R (option c of claim 9). Claim 9of ‘650 states that one of the two heavy chains may comprise L234F, L325E, and D265A amino acid substitutions (relevant to instant claim 3). Additionally, the antibody is enabled for controlled isomerization by the presence of a F405L mutation in the CH3 domain of one of the antibodies and the presence of a K409R mutation in the CH3 domain of the other antibody (relevant to instant claims 16, 19, 20-22, and 37).
Claims 1, 4, 5, 13, 16, 17, 24, 25, 29- 34, and 42, are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of U.S. Patent No. 11932693 (herein ‘693). Although the claims at issue are not identical, they are not patentably distinct from each other, because the invention disclosed in ‘693 encompasses the invention disclosed in the current application, as explained below.
Claims 1-30 of ‘693 refer to either an anti-PD-1 antibody (comprising L234F, L235E, and G236R amino acid substitutions within the IgG1 CH2 domain), a nucleic acid encoding said antibody, or a pharmaceutical composition comprising the antibody or the nucleic acid.
Claims 1, 3-6, 9, 11-13, 16-22, 24-34, 37, and 40-43 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-22 of U.S. Patent No. 12398214 (herein ‘214). Although the claims at issue are not identical, they are not patentably distinct from each other, because the invention disclosed in ‘214 is encompassed by the invention disclosed in the current application, as explained below.
Claim 1 of ‘214 refers to an anti-EpCAM/CD137 bispecific antibody (relevant to instant claims 1, 6, 9, 11-13, 17, 18, and 26) wherein at least one IgG1 heavy chain has amino acid substitutions at positions 234, 235, and 236 (relevant to instant claims 1, 2, 4, and 5). Claim 1 of ‘214 states that one of the two heavy chains may comprise L234F, L325E, and D265A amino acid substitutions (relevant to instant claim 3). Additionally, as defined in claim 1 of ‘214, the antibody is enabled for controlled isomerization by the presence of a F405L mutation in the CH3 domain of one of the antibodies and the presence of a K409R mutation in the CH3 domain of the other antibody (relevant to instant claims 16, 19, 20, 21, 22, and 37). Claims 20-22 and 116 of ‘214 relate to methods of using the antibody or a pharmaceutical composition comprising the antibody as treatment, which is relevant to instant claims 33 and 34.
Conclusion
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MATTHEW CURRAN METCALF whose telephone number is (571)272-5520. The examiner can normally be reached 7:30AM-5:00PM.
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, Joanne Hama, can be reached at (571)272-2911. 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.
/MATTHEW CURRAN METCALF/Examiner, Art Unit 1647 /JOANNE HAMA/Supervisory Patent Examiner, Art Unit 1647
Prosecution Insights