DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Applicant’s response and amendments received March 27, 2026 are acknowledged.
Claims 2-24, 26, 27, 30, and 32-36 have been canceled.
Claims 1, 25, 28, 29, 31, 41, and 42 have been amended.
Claims 45 and 46 have been added.
Claims 1, 25, 28, 29, 31, and 37-46 are pending in the instant application.
Claims 37, 38 and 42-44 stand withdrawn and newly presented claim 46 is withdrawn (claim 46 is part of group V drawn to methods of administration) from consideration as being drawn to a nonelected invention. See 37 CFR 1.142(b) and MPEP § 821.03, for reasons of record set forth in the restriction requirement mailed July 28, 2025.
Claims 1, 25, 28, 29, 31, 39-41, and 45 are under examination in this office action.
Information Disclosure Statement
The IDS form received 3/27/2026 is acknowledged and the references cited therein have been considered.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
The rejection of claims 27, 28, 30, and 31 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112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement has been withdrawn in view of applicant’s claim amendments received March 37, 2026.
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, 25, 28, 29, 31, 39-41, and 45 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 26-32, 34-38, and 40-49 of copending Application No. 18/002,499. Although the claims at issue are not identical, they are not patentably distinct from each other because the copending claims anticipate or render obvious that which is presently claimed.
Specifically, the copending claims are drawn to bispecific antibodies that bind B7-H4 and 4-1BB. Notably, the 4-1BB antibodies are disclosed as comprising the same biological sequences as those of the instant claimed PR004469 clone (see enclosed sequence alignments and note that instant SEQ ID NO:198 is identical to copending SEQ ID NO: 161 (i.e. the VH ae the same) while instant SEQ ID NO 240 is identical to copending SEQ ID NO: 193 (i.e. the full length heavy chain only antibodies are identical). The copending claims explicitly recite by SEQ ID number bispecific antibodies comprising the PR004460 clone (see all claims, for example claims 31 and 32 in particular). Pharmaceutical compositions comprising such antibodies, as well as ADC comprising the cytotoxins MMAE and MMAF are all explicitly claimed (see particularly copending claims 42, 44, and 45). Given that the antibodies of the copending application are necessarily bispecific and bind B7-H4 in addition to 4-1BB the copending antibodies comprise additional limitations, and therefore are narrower in scope, than that which is presently claimed. Alternatively, given that bispecific antibodies are not naturally occurring and are made recombinantly by joining together structural elements from pre-existing monospecific antibodies, the instant claimed monospecific antibodies are simply the starting materials used to make the copending bispecific antibodies. Given one is necessarily in possession of the starting monospecific antibodies prior to making them into bispecifics, such starting reagents are exceedingly obvious in view of the final bispecific product.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Applicant's arguments filed March 27, 2026 have been fully considered but they are not persuasive. Applicant argues that the instant claims recite monospecificity, the copending claims require bispecificity (anti-CD137/4-1BB x anti-B7-H4 to be precise) and that modifying a bispecific antibody into a monospecific antibody makes it unsatisfactory for its intended purpose and thus the rejection is improper.
These arguments have bene considered and are not persuasive. A bispecific antibody is made by combining structural elements from staring monospecific antibodies. Thus the instant claimed monospecific antibody is a starting reagent needed to make the copending bispecific antibody, as is readily evidenced by the exact same SEQ ID numbers being present in the instant claimed and copending applications (see most particularly the sequence alignments provide with the prior office action). As such applicant’s arguments that artisans cannot arrive at monospecific reagents from a bispecific reagent cannot be persuasive as the monospecific reagent necessarily comes first as a starting material. With regard to being “unsatisfactory for intended purpose” an antibody binds its cognate antigen, in the instant case that is CD137/4-1BB. This binding occurs whether it is mono, bi, tri, or some other higher order specificity. Indeed, as has already been made of record, the antigen binding structures for the anti-CD137/4-1BB are the same as they have the same biological sequences. Applicant is reminded that they have claimed a product, NOT a method of using a product. Since the biological sequences are the same, binding to the same antigen (and hence the “intended purpose” of an antibody) is the same. Further, it should be noted that there is no restriction requirement which necessitated applicant filing the subject matter of the copending application as a separate application relative to the instant application, and the filing dates for the instant and copending applications are identical (i.e., 6/29/2021).
The provisional rejection of claims 1, 25, and 27-31 on the ground of nonstatutory double patenting as being unpatentable over claims 20-37 of copending Application No. 18/002,655 has been withdrawn in view of applicant’s claim amendments in the copending application which presently separate the subject matter of the copending application from that which is presently claimed.
Claims 1, 25, 28, 29, 31, and 45 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 and 16-21 of copending Application No. 18/013,523. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are anticipated by or are obvious variants of the copending claims.
Specifically, the copending claims are drawn to bispecific antibodies that at least two different antigens, wherein one of the antigens 4-1BB. Notably, the 4-1BB antigen binding domains are disclosed as comprising the same biological sequences as those of the instant claimed PR004469 clone (see enclosed sequence alignments and note that instant SEQ ID NO:198 is identical to copending SEQ ID NO: 167 (i.e. the VH ae the same) while instant SEQ ID NO 240 is identical to copending SEQ ID NO: 198 (i.e. the full length heavy chain only antibodies are identical). The copending claims explicitly recite by SEQ ID number bispecific binding proteins comprising the PR004460 clone (see all claims, for example claims 18 and 19 in particular). Pharmaceutical compositions comprising such antibodies are explicitly claimed (see particularly copending claim 11). Given that the antibodies of the copending application are necessarily bispecific and bind antigens in addition to 4-1BB the copending antibodies comprise additional limitations, and therefore are narrower in scope, than that which is presently claimed. Alternatively, given that bispecific antibodies are not naturally occurring and are made recombinantly by joining together structural elements from pre-existing monospecific antibodies, the instant claimed monospecific antibodies are simply the starting materials used to make the copending bispecific antibodies. Given one is necessarily in possession of the starting monospecific antibodies prior to making them into bispecifics, such starting reagents are exceedingly obvious in view of the final bispecific product.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Applicant's arguments filed March 27, 2026 have been fully considered but they are not persuasive. Applicant argues that the instant claims recite monospecificity, the copending claims require bispecificity and that modifying a bispecific antibody into a monospecific antibody makes it unsatisfactory for its intended purpose and thus the rejection is improper.
These arguments have bene considered and are not persuasive. A bispecific antibody is made by combining structural elements from staring monospecific antibodies. Thus the instant claimed monospecific antibody is a starting reagent needed to make the copending bispecific antibody, as is readily evidenced by the exact same SEQ ID numbers being present in the instant claimed and copending applications (see most particularly the sequence alignments provide with the prior office action). As such applicant’s arguments that artisans cannot arrive at monospecific reagents from a bispecific reagent cannot be persuasive as the monospecific reagent necessarily comes first as a starting material. With regard to being “unsatisfactory for intended purpose” an antibody binds its cognate antigen, in the instant case that is CD137/4-1BB. This binding occurs whether it is mono, bi, tri, or some other higher order specificity. Indeed, as has already been made of record, the antigen binding structures for the anti-CD137/4-1BB are the same as they have the same biological sequences. Applicant is reminded that they have claimed a product, NOT a method of using a product. Since the biological sequences are the same, binding to the same antigen (and hence the “intended purpose” of an antibody) is the same. Further, it should be noted that there is no restriction requirement which necessitated applicant filing the subject matter of the copending application as a separate application relative to the instant application, and the filing dates for the instant and copending applications are identical (i.e., 6/29/2021).
Claims 1, 25, 28, 29, 31, and 45 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No. 18/571,174. Although the claims at issue are not identical, they are not patentably distinct from each other because the copending claims anticipate that which is presently claimed.
Specifically, the copending claims are drawn to bispecific antibody combinations wherein at least one of the targeted antigens 4-1BB. Notably, the 4-1BB antigen binding domains are disclosed as comprising the same biological sequences as those of the instant claimed PR004469 clone (see enclosed sequence alignments and note that instant SEQ ID NO:198 is identical to copending SEQ ID NO: 68 (i.e. the VH ae the same) while instant SEQ ID NO 240 is identical to copending SEQ ID NO: 79 (i.e. the full length heavy chain only antibodies are identical). The copending claims explicitly recite by SEQ ID number bispecific binding proteins comprising the PR004460 clone (see all claims, for example claims 4 and 5 in particular). Pharmaceutical compositions comprising such antibodies are explicitly claimed (see particularly copending claim 10). Given that the antibodies of the copending application are necessarily bispecific and bind antigens in addition to 4-1BB the copending antibodies comprise additional limitations, and therefore are narrower in scope, than that which is presently claimed.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Applicant's arguments filed March 27, 2026 have been fully considered but they are not persuasive. Applicant argues the copending application is later filed relative to the instant application and therefore the instant provisional rejection should be withdrawn.
This argument has been considered and is not persuasive. While applicant is correct that the ‘174 application is later filed relative to the instant application, this exact provisional rejection is not the only remaining issue precluding allowance as discussed earlier in this office action. As such applicant’s procedural argument cannot be found persuasive at this time.
Claims 39-41 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 and 16-21 of copending Application No. 18/013,523, or claims 1-20 of copending Application No. 18/571,174, either of which in view of Boitano et al. (WO 2020/023556).
The inventions of the copending claims have been discussed above and differ from the instant claimed invention in that the bispecific antibodies of the copending claims are not recited as being ACD that comprise toxins such as MMAE or MMAF.
Boitano et al. disclose antibody-drug conjugates (ADC) that bind to CD137, which is another name for 4-1BB (see entire document, particularly the title, abstract, and claims). Such ADC are explicitly claimed as comprising the auristatins MMAE or MMAF (see particularly claim 20) with ADC being disclosed as being advantageous as they target cytotoxins to reduce off-target side effects (see for example pages 18 and 45).
Therefore, it would have been obvious to an ordinary artisan at the time of the instant invention that the bispecific anti-4-1BB/CD137 antibodies of the copending claims could be converted into ADC in order to gain the advantage of reduced off-target effects as disclosed by Boitano et al. Artisans would have a reasonable expectation of success in doing so as ADC comprising anti-4-1BB/CD137 and their production were known in the prior art as shown by Boitano et al.
This is a provisional nonstatutory double patenting rejection.
Applicant's arguments filed March 27, 2026 have been fully considered but they are not persuasive. Applicant argues the base NSDP rejections are not tenable and that the additional teachings of Boitano et al. fail to rectify the alleged deficiencies.
This argument is acknowledged and is not persuasive as the base double patenting rejections have been maintained as discussed above.
No claims are allowable.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Michael Szperka whose telephone number is (571)272-2934. The examiner can normally be reached Monday-Friday 8:30-5:00.
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, Misook Yu can be reached at 571-272-0839. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Michael Szperka
Primary Examiner
Art Unit 1641
/MICHAEL SZPERKA/Primary Examiner, Art Unit 1641
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