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 .
Response to Amendment
In the amendment filed on 12/23/2025 Applicant amended claims 1-4, 14-16, 18-21, 27 and 29-31. Claims 1-31 are pending and are examined.
Maintained claim rejections
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.
Claims 1, 2, 5-18 and 21-31 rejected 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. The claims contain subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor, at the time the application was filed, had possession of the claimed invention for reasons of record. Specifically, while Applicant amended the claims to indicate methods of treatment of particular cancers (that expresses human sperm protein 17 (Sp17)), there is no representative number of species disclosed. the therapeutic dimer claimed to be used in the genus of methods to be used is represented by one dimer formed between two identical anti-SP17 antibodies of disclosed structure when one of the antibodies is linked to derutexcan (DXD) and the other linked to Ozogamicin. The requirement for the therapeutic to be used is to comprise a first immunoconjugate and a second immuno- conjugate that are covalently crosslinked. The first immunoconjugate comprises any first antibody that binds to any first cancer associated antigen and any first payload selected from any first radioactive isotope and any first pharmaceutical agent. The second immunoconjugate comprises any second antibody that binds to any second cancer associated antigen and any second payload selected from any second radioactive isotope and any second pharmaceutical agent. The only requirement is that the first payload and the second payload are different. As may easily be noticed, the genus of dimers is so vast given that no structure is conferred to any of its components (antibodies, cancer associated antigens, radioactive isotopes or pharmaceuticals). Clearly a person of ordinary skill in the art would conclude that the specification fails to disclose a representative number of species to describe the claimed genera since only one specie is disclosed for this vast genus.
On page 14 of the Remarks Applicant argues that: “at least paragraphs [0108]-[0116] of the Present Application also provide support and enablement for the claimed immunotherapeutic and its methods of use.”
The arguments were carefully considered but not found persuasive because, as indicated supra, only one specie is disclosed that constitute the immunotherapeutic claimed in the method of use, while the genus is enormous.
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 1-28 remain rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of U.S. Patent No.12,364,777. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the patent anticipate the instant claims 1-28.
Claims 1-12 and 17-28 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of U.S. Patent No. 12,319,747 in view of Kaminski et al. (U.S. Pat. 6,565,827) ('827; cited by Applicant).
The claims are drawn to an immunotherapeutic and method of using in a method to treat a cancer that expresses human sperm protein17 (Sp17) in a human subject, comprising administering a therapeutically effective amount of the immunotherapeutic to the human subject, wherein: the immunotherapeutic comprises a first immuno-conjugate and a second immunoconjugate that are covalently crosslinked; the first immunoconjugate comprises a first antibody that binds to a first cancer-associated antigen and a first payload selected from a first radioactive isotope and a first pharmaceutical agent; the second immunoconjugate comprises a second antibody that binds to a second cancer associated antigen and a second payload selected from a second radioactive isotope and a second pharmaceutical agent; and the first payload and the second payload are different. The first antibody and the second antibody each
comprise two antigen-binding sites that each specifically bind Sp17 such that the
immunotherapeutic comprises exactly four antigen-binding sites that each specifically
bind Sp17; the first antibody and the second antibody each comprise a first variable
domain and a second variable domain; the first variable domain of the first antibody and
the first variable domain of the second antibody have identical amino acid sequences;
the second variable domain of the first antibody and the second variable domain of the
second antibody have identical amino acid sequences; the first variable domain of the
first antibody and the second antibody comprises a VH CDR1 region comprising an amino acid sequence that is identical to SEQ ID NO: 5, a VH CDR2 region comprising an amino acid sequence that is identical to SEQ ID NO: 6, and a VH CDR3 region comprising an amino acid sequence that is identical to SEQ ID NO: 7; and the second variable domain of the first antibody and the second antibody comprises a VL CDR1 region comprising an amino acid sequence that is identical to SEQ ID NO: 8, a VL CDR2 region comprising an amino acid sequence that is identical to SEQ ID NO: 9, and a VL CDR3 region comprising an amino acid sequence that is identical to SEQ ID NO: 10. Further, the claims indicate that the antibodies are conjugated with radioactive isotope and/or cytotoxic moieties.
The claims of the ‘747 Patent are drawn to methods to modulate or treating cancers cells that express Sp17 in a human subject, comprising administering an immunotherapeutic agent to the human subject, wherein: the immunotherapeutic agent comprises a first variable domain that comprises a VH CDR1 region comprising SEQ ID NO: 5, a VH CDR2 region comprising SEQ ID NO: 6, and a VH CDR3 region comprising SEQ ID NO: 7; and a second variable domain that comprises a VL CDR1 region comprising SEQ ID NO: 8, a VL CDR2 region comprising SEQ ID NO: 9, and a VL CDR3 region comprising SEQ ID NO: 10; and wherein the immunotherapeutic agent binds human sperm protein 17 (Sp17).
The ‘747 patent is silent about the conjugation of the dimer with radioactive or cytotoxic moieties. However, the art at the time that the invention was filed was aware of the superiority of the antibodies comprising conjugates with radioactive isotopes and/or
cytotoxins, as disclosed in '827 U.S. Patent (col. 7, I. 15-19; col. 2, I. 24-54). Indeed the
'827 patent indicates the immunoconjugates harboring radioactive isotopes and/or
cytotoxins and describe the superiority of the immunoconjugates in method of use since
systemic toxicity from cytotoxins or radioactive isotopes will be averted by the specificity
of the antibodies.
Claim17-28 remain rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. 12,121,587 in view of Kaminski
et al. (U.S. Pat. 6,565,827) ('827; cited by Applicant).
The claims are drawn to an immunotherapeutic that comprises a first immunoconjugate and a second immunoconjugate that are covalently crosslinked; the first immunoconjugate comprises a first antibody that binds to a first cancer associated
antigen and a first payload selected from a first radioactive isotope and a first
pharmaceutical agent; the second immunoconjugate comprises a second antibody that
binds to a second cancer associated antigen and a second payload selected from a
second radioactive isotope and a second pharmaceutical agent; and the first payload and the second payload are different. The first antibody and the second antibody each
comprise two antigen-binding sites that each specifically bind Sp17 such that the
immunotherapeutic comprises exactly four antigen-binding sites that each specifically
bind Sp17; the first antibody and the second antibody each comprise a first variable
domain and a second variable domain; the first variable domain of the first antibody and
the first variable domain of the second antibody have identical amino acid sequences;
the second variable domain of the first antibody and the second variable domain of the
second antibody have identical amino acid sequences; the first variable domain of the
first antibody and the second antibody comprises a VH CDR1 region comprising an amino acid sequence that is identical to SEQ ID NO: 5, a VH CDR2 region comprising an amino acid sequence that is identical to SEQ ID NO: 6, and a VH CDR3 region comprising an amino acid sequence that is identical to SEQ ID NO: 7; and the second variable domain of the first antibody and the second antibody comprises a VL CDR1 region comprising an amino acid sequence that is identical to SEQ ID NO: 8, a VL CDR2 region comprising an amino acid sequence that is identical to SEQ ID NO: 9, and a VL CDR3 region comprising an amino acid sequence that is identical to SEQ ID NO: 10. Further, the claims indicate that the antibodies are conjugated with radioactive isotope and/or cytotoxic moieties.
The claims of the "587 patent are drawn to dimers of an anti-SP17 antibody which harbors the same variable domains of the instantly claimed immunoconjugates. The reference is silent about the conjugation of the dimer with radioactive or cytotoxic
moieties. However, the art at the time that the invention was filed was aware of the
superiority of the antibodies comprising conjugates with radioactive isotopes and/or
cytotoxins, as disclosed in '827 U.S. Patent (col. 7, I. 15-19; col. 2, I. 24-54). Indeed the
'827 patent indicates the immunoconjugates harboring radioactive isotopes and/or
cytotoxins and describe the superiority of the immunoconjugates in method of use since
systemic toxicity from cytotoxins or radioactive isotopes will be averted by the specificity
of the antibodies.
Claims 1-12 and 17-28 remain provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-17 of copending Application No. 18/408,414 in view of Wolff et al. (cited preciously).
The claims of the'414 Application are drawn to a recombinant antibody or antigen binding fragment thereof, that specifically binds human sperm protein 17 (anti-Sp17),
comprising two variable domains, wherein: the antibody or antigen-binding fragment
thereof comprises a first variable domain that comprises a VH CDR1 region comprising an amino acid sequence that is identical to at least 7 consecutive amino acids set forth in SEQ ID NO: 5, a VH CDR2 region comprising an amino acid sequence that is identical to at least 7 consecutive amino acids set forth in SEQ ID NO: 6, and a VH CDR3 region comprising an amino acid sequence that is identical to at least 7 consecutive amino acids set forth in SEQ ID NO: 7; and wherein the antibody or antigen-binding fragment thereof comprises a second variable domain that comprises a VL CDR1 region comprising an amino acid sequence that is identical to at least 7 consecutive amino acids set forth in SEQ ID NO: 8, a VL CDR2 region comprising an amino acid sequence that is identical to at least 3 consecutive amino acids set forth in SEQ ID NO: 9, and a VL CDR3 region comprising an amino acid sequence that is identical to at least 5 consecutive amino acids set forth in SEQ ID NO: 10. The antibody may be conjugated to a radioactive isotope that may be actinium-225, astatine-211, bismuth-212, bismuth-213, copper-67, gallium-68, holmium-166, iodine-124, iodine-131, lutetium-177, samarium-153, technetium-99, terbium-149, or yttrium-90. The antibody may be conjugated to a moiety selected from a calicheamicin, camptothecin, deruxtecan, doxorubicin, emtansine, exatecan, irinotecan, maleimidocaproyl monomethyl auristatin F, mertansine, monomethyl auristatin F, paclitaxel, PE38, pyrrolobenzodiazepine, SN-38, and vedotin. The '414 Application is silent about dimers of the immunoconjugates mentioned.
However, Wolff et al. studied the relative in vivo antitumor effects of a human murine chimeric monoclonal lgG (ChiBR96) which strongly binds to a variety of breast,
lung, ovary, and colon carcinomas. The lgG monomer and dimer were studied in nude
mice bearing human lung adenocarcinoma xenografts. The dimer was more effective In
slowing tumor progression despite having a shorter serum half-life than the monomer. Increasing the valency of lgG monoclonal antibodies may be a useful approach to
enhancing their biological efficacy.
Thus it would have been obvious for a person of ordinary skill in the art at the time that the invention was filed to have followed the teaching of Wolff et al. and dimerize the immunoconjugates disclosed by '414 Application with a reasonable expectation of success. This is because the immunoconjugates were described in the '414 Application and the benefit of dimerizing immunoconjugates was underscored by Wolff et al.
This is a provisional nonstatutory double patenting rejection.
Conclusion
No claims are allowed.
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 ELLY GERALD STOICA whose telephone number is (571)272-9941. The examiner can normally be reached M-F 8-5 EST.
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ELLY-GERALD STOICA
Primary Examiner
Art Unit 1647
/Elly-Gerald Stoica/Primary Examiner, Art Unit 1647