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 .
Election/Restrictions
Applicant's reply to the Restriction Requirement, dated February 27, 2026, has been received. By way of this submission, Applicant has elected, without traverse, abiraterone as the species of anti-androgen therapy, sarilumab as the species of IL-6R antagonist, BSPSMA/CD28-001 as the species of bispecific anti-PSMA x anti-CD28 antibody, cemiplimab as the species of anti-PD-1 antibody, and metastatic prostate cancer as the species of PSMA-expressing cancer.
Claims 1-12, 16, 20-22, 24-25, 27-28 and 47-67 are pending in the application. Claims 4 and 8-10 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on February 27, 2026.
Claims 1-3, 5-7, 11-12, 16, 20-22, 24-25, 27-28 and 47-67 are therefore under examination before the Office.
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-3, 6, 16, 20-22, 24-25, 27-28, 47-63, and 65-67 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Murphy (US20190389951A1, cited in IDS).
Murphy teaches a bispecific antibody that binds CD28 and PSMA (para. 0010). Murphy further teaches an anti-CD28 heavy chain amino acid sequence of SEQ ID NO: 81, which completely encompasses Applicant's SEQ ID NO: 14, an anti-PSMA heavy chain amino acid sequence of SEQ ID NO: 82, which completely encompasses Applicant's SEQ ID NO: 13, and a common light chain amino acid sequence for both antibodies of SEQ ID NO: 83, which completely encompasses Applicant's SEQ ID NO: 15 (para. 0228), which is pertinent to claims 1, 16, 20, and 27-28.
Murphy further teaches that this antibody is useful in treating cancers that express PSMA, such as prostate cancer (para. 0010).
Murphy further teaches that this antibody may be used in combination with an anti-PD-1 antibody (para/ 0035).
Murphy further teaches that the suitable dosage may be between about 0.01 to about 20 mg/kg body weight (para. 0189). Assuming a 70 kg patient, this would result in a dosage of between about .7 to about 1,400 mg.
Murphy further teaches that this antibody is useful in treating metastatic tumors (para. 0198), which is pertinent to claim 3.
Murphy further teaches administering the above antibody after the patient has been treated with an anti-androgen (para. 0205-206), which is pertinent to claim 6.
Murphy further teaches that this antibody may have a human IgG1 constant region (para. 0151), which is pertinent to claims 21-22.
Murphy further teaches that this antibody may have a chimeric hinge region with altered Fc receptor binding (para. 0151), which is pertinent to claim 24.
Murphy further teaches that this antibody may have a CH3 domain with an H435R or Y436F mutation (para. 015), which is pertinent to claim 25.
Murphy further teaches that the anti-PD-1 antibody may be cemiplimab (para. 0389). According to Applicant's specification at page 20, cemiplimab is an antibody comprising a heavy chain comprising the amino acid sequence of SEQ ID NO: 44 and a light chain comprising the amino acid sequence of SEQ ID NO: 45. Murphy therefore inherently teaches the sequences of claims 47-51.
Murphy further teaches a dosage schedule of one every week, or once ever three weeks (para. 0210), which is pertinent to claims 52-61.
Murphy further teaches that this method of treatment may further comprise an anti-IL-6 receptor antibody (para. 02023), which is pertinent to claims 65-66.
While Murphy does not teach a decline in prostate specific antigen (PSA) levels in the subject, the method of Murphy is identical to that of the claimed method, and would therefore result in in identical results. These results are a natural result of the prior art. Murphy therefore teaches the subject matter of claim 67.
It is noted that In re Best (195 USPQ 430) and In re Fitzgerald (205 USPQ 594) discuss the support of rejections wherein the prior art discloses subject matter which there is reason to believe inherently includes functions that are newly cited or is identical to a product instantly claimed. In such a situation the burden is shifted to the applicants to "prove that subject matter shown to be in the prior art does not possess characteristic relied on" (205 USPQ 594, second column, first full paragraph). It is noted that, if the prior art discloses identical chemical structure, the properties applicant discloses and/or claims are necessarily present, In re Spada, 911 F.2d 705, 709, 15 USPQ2d.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-3, 5-7, 11-12, 16, 20-22, 24-25, 27-28 and 47-67 are rejected under 35 U.S.C. 103 as being unpatentable over Murphy (US20190389951A1, cited in IDS) in view of Drake (J Clin Onco, (2020) Vol. 38, No. 15. Abstract TPS5592, cited in IDS) and Kouros-Mehr (WO2022060878A1).
Murphy teaches a bispecific antibody that binds CD28 and PSMA (para. 0010). Murphy further teaches an anti-CD28 heavy chain amino acid sequence of SEQ ID NO: 81, which completely encompasses Applicant's SEQ ID NO: 14, an anti-PSMA heavy chain amino acid sequence of SEQ ID NO: 82, which completely encompasses Applicant's SEQ ID NO: 13, and a common light chain amino acid sequence for both antibodies of SEQ ID NO: 83, which completely encompasses Applicant's SEQ ID NO: 15 (para. 0228), which is pertinent to claims 1, 16, 20, and 27-28.
Murphy further teaches that this antibody is useful in treating cancers that express PSMA, such as prostate cancer (para. 0010).
Murphy further teaches that this antibody may be used in combination with an anti-PD-1 antibody (para/ 0035).
Murphy further teaches that the suitable dosage may be between about 0.01 to about 20 mg/kg body weight (para. 0189). Assuming a 70 kg patient, this would result in a dosage of between about .7 to about 1,400 mg.
Murphy further teaches that this antibody is useful in treating metastatic tumors (para. 0198), which is pertinent to claim 3.
Murphy further teaches administering the above antibody after the patient has been treated with an anti-androgen (para. 0205-206), which is pertinent to claim 6.
Murphy further teaches that this antibody may have a human IgG1 constant region (para. 0151), which is pertinent to claims 21-22.
Murphy further teaches that this antibody may have a chimeric hinge region with altered Fc receptor binding (para. 0151), which is pertinent to claim 24.
Murphy further teaches that this antibody may have a CH3 domain with an H435R or Y436F mutation (para. 015), which is pertinent to claim 25.
Murphy further teaches that the anti-PD-1 antibody may be cemiplimab (para. 0389). According to Applicant's specification at page 20, cemiplimab is an antibody comprising a heavy chain comprising the amino acid sequence of SEQ ID NO: 44 and a light chain comprising the amino acid sequence of SEQ ID NO: 45. Murphy therefore inherently teaches the sequences of claims 47-51.
Murphy further teaches a dosage schedule of one every week, or once ever three weeks (para. 0210), which is pertinent to claims 52-61.
Murphy further teaches that this method of treatment may further comprise an anti-IL-6 receptor antibody (para. 02023), which is pertinent to claims 65-66.
While Murphy does not teach a decline in prostate specific antigen (PSA) levels in the subject, the method of Murphy is identical to that of the claimed method, and would therefore result in in identical results. These results are a natural result of the prior art. Murphy therefore teaches the subject matter of claim 67.
It is noted that In re Best (195 USPQ 430) and In re Fitzgerald (205 USPQ 594) discuss the support of rejections wherein the prior art discloses subject matter which there is reason to believe inherently includes functions that are newly cited or is identical to a product instantly claimed. In such a situation the burden is shifted to the applicants to "prove that subject matter shown to be in the prior art does not possess characteristic relied on" (205 USPQ 594, second column, first full paragraph). It is noted that, if the prior art discloses identical chemical structure, the properties applicant discloses and/or claims are necessarily present, In re Spada, 911 F.2d 705, 709, 15 USPQ2d.
However, Murphy does not teach at least two prior lines of systemic therapy.
Drake teaches a method of treating patients with metastatic castration resistant prostate cancer, comprising administering REGN5678 in combination with cemiplimab (page 1). According to Applicant's specification at page 8, REGN5678 is a bispecific anti-PSMA x CD28 antibody, and cemiplimab is an anti-PD-1 antibody. According to Applicant's specification at Table 2, REGN5678 (a.k.a. BSPSMA/CD28-001) has an anti-PSMA antigen-binding domain heavy chain variable region of SEQ ID NO: 1, an anti-CD28 domain heavy chain variable region of SEQ ID NO: 5, and a common light chain variable region of SEQ ID NO: 9. According to Applicant's specification at page 20, cemiplimab is an antibody comprising a heavy chain comprising the amino acid sequence of SEQ ID NO: 44 and a light chain comprising the amino acid sequence of SEQ ID NO: 45. Drake therefore inherently teaches these sequences.
Drake further teaches that the patient must have received at least two prior lines of systemic therapy and anti-androgen therapy such as abiraterone, and a luteinizing hormone-releasing hormone (LHRH) agonist (page 3), which is pertinent to claims 5 and 7.
Kouros-Mehr teaches that treatments of metastatic prostate cancer include orchiectomy, the anti-androgen abiraterone, or LHRH agonists or antagonists (para. 0076), which is pertinent to claim 11.
Kouros-Mehr further teaches that a patient with metastatic prostate cancer may have a total serum testosterone level of 50 ng/dL or less (para. 0035), which is pertinent to claim 12.
Kouros-Mehr further teaches that a patient with metastatic prostate cancer with a bispecific antibody may result in a complete response, a partial response, or a stable disease response (para. 0040), which is pertinent to claim 64.
Kouros-Mehr further teaches that the patient may also be administered the IL-R antagonist sarilumab (para. 0071), which is pertinent to claim 65.
It would have been prima facie obvious for a person of ordinary skill in the art as of the effective filing date to combine the teachings of Murphy, Drake, and Kouros-Mehr to arrive at the claimed invention. An ordinary artisan would have been motivated to do so, and have a reasonable expectation of success, since all of Murphy, Drake, and Kouros-Mehr are concerned with treatment of metastatic prostate cancer. Methods of treating prostate cancer with a bispecific anti-PSMA and anti-CD28 bispecific antibody in combination with the anti-PD-1 antibody cemiplimab were known in the art, according to both Murphy and Drake. Drake and Kouros-Mehr further inform the skilled artisan of conventional treatments in the field that may be used in this context, and suitable patient selection parameters. One of ordinary skill could apply the teachings of Drake and Kouros-Mehr to the methods of Murphy to arrive at the claimed invention, with each component of the combination performing its known, usual function, to affect a predictable result.
All the claimed elements were known in the prior art and one of ordinary skill in the art could have arrived at the claimed invention by using known methods with no change in their respective functions, and the combination would have yielded nothing more than predictable results.
Therefore, the invention, as a whole, was prima facie obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention as evidenced by the references, especially in the absence of evidence to the contrary.
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, 5-7, 11-12, 16, 20-22, 24-25, 27-28 and 47-67 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4, 6, 8-9, 11, 15 of U.S. Patent No. 11,548,947 in view of Murphy, Drake, and Kouros-Mehr.
The '947 patent claims bispecific antibodies that bind PSMA and CD28, and has identical sequences of those of the instant claims (see, e.g., claim 1). However, the '947 patent does not claim a method of treatment of prostate cancer, or coadministration with cemiplimab.
Murphy teaches a bispecific antibody that binds CD28 and PSMA (para. 0010). Murphy further teaches an anti-CD28 heavy chain amino acid sequence of SEQ ID NO: 81, which completely encompasses Applicant's SEQ ID NO: 14, an anti-PSMA heavy chain amino acid sequence of SEQ ID NO: 82, which completely encompasses Applicant's SEQ ID NO: 13, and a common light chain amino acid sequence for both antibodies of SEQ ID NO: 83, which completely encompasses Applicant's SEQ ID NO: 15 (para. 0228), which is pertinent to claims 1, 16, 20, and 27-28.
Murphy further teaches that this antibody is useful in treating cancers that express PSMA, such as prostate cancer (para. 0010).
Murphy further teaches that this antibody may be used in combination with an anti-PD-1 antibody (para/ 0035).
Murphy further teaches that the suitable dosage may be between about 0.01 to about 20 mg/kg body weight (para. 0189). Assuming a 70 kg patient, this would result in a dosage of between about .7 to about 1,400 mg.
Murphy further teaches that this antibody is useful in treating metastatic tumors (para. 0198), which is pertinent to claim 3.
Murphy further teaches administering the above antibody after the patient has been treated with an anti-androgen (para. 0205-206), which is pertinent to claim 6.
Murphy further teaches that this antibody may have a human IgG1 constant region (para. 0151), which is pertinent to claims 21-22.
Murphy further teaches that this antibody may have a chimeric hinge region with altered Fc receptor binding (para. 0151), which is pertinent to claim 24.
Murphy further teaches that this antibody may have a CH3 domain with an H435R or Y436F mutation (para. 015), which is pertinent to claim 25.
Murphy further teaches that the anti-PD-1 antibody may be cemiplimab (para. 0389). According to Applicant's specification at page 20, cemiplimab is an antibody comprising a heavy chain comprising the amino acid sequence of SEQ ID NO: 44 and a light chain comprising the amino acid sequence of SEQ ID NO: 45. Murphy therefore inherently teaches the sequences of claims 47-51.
Murphy further teaches a dosage schedule of one every week, or once ever three weeks (para. 0210), which is pertinent to claims 52-61.
Murphy further teaches that this method of treatment may further comprise an anti-IL-6 receptor antibody (para. 02023), which is pertinent to claims 65-66.
While Murphy does not teach a decline in prostate specific antigen (PSA) levels in the subject, the method of Murphy is identical to that of the claimed method, and would therefore result in in identical results. These results are a natural result of the prior art. Murphy therefore teaches the subject matter of claim 67.
It is noted that In re Best (195 USPQ 430) and In re Fitzgerald (205 USPQ 594) discuss the support of rejections wherein the prior art discloses subject matter which there is reason to believe inherently includes functions that are newly cited or is identical to a product instantly claimed. In such a situation the burden is shifted to the applicants to "prove that subject matter shown to be in the prior art does not possess characteristic relied on" (205 USPQ 594, second column, first full paragraph). It is noted that, if the prior art discloses identical chemical structure, the properties applicant discloses and/or claims are necessarily present, In re Spada, 911 F.2d 705, 709, 15 USPQ2d.
However, Murphy does not teach at least two prior lines of systemic therapy.
Drake teaches a method of treating patients with metastatic castration resistant prostate cancer, comprising administering REGN5678 in combination with cemiplimab (page 1). According to Applicant's specification at page 8, REGN5678 is a bispecific anti-PSMA x CD28 antibody, and cemiplimab is an anti-PD-1 antibody. According to Applicant's specification at Table 2, REGN5678 (a.k.a. BSPSMA/CD28-001) has an anti-PSMA antigen-binding domain heavy chain variable region of SEQ ID NO: 1, an anti-CD28 domain heavy chain variable region of SEQ ID NO: 5, and a common light chain variable region of SEQ ID NO: 9. According to Applicant's specification at page 20, cemiplimab is an antibody comprising a heavy chain comprising the amino acid sequence of SEQ ID NO: 44 and a light chain comprising the amino acid sequence of SEQ ID NO: 45. Drake therefore inherently teaches these sequences.
Drake further teaches that the patient must have received at least two prior lines of systemic therapy and anti-androgen therapy such as abiraterone, and a luteinizing hormone-releasing hormone (LHRH) agonist (page 3), which is pertinent to claims 5 and 7.
Kouros-Mehr teaches that treatments of metastatic prostate cancer include orchiectomy, the anti-androgen abiraterone, or LHRH agonists or antagonists (para. 0076), which is pertinent to claim 11.
Kouros-Mehr further teaches that a patient with metastatic prostate cancer may have a total serum testosterone level of 50 ng/dL or less (para. 0035), which is pertinent to claim 12.
Kouros-Mehr further teaches that a patient with metastatic prostate cancer with a bispecific antibody may result in a complete response, a partial response, or a stable disease response (para. 0040), which is pertinent to claim 64.
Kouros-Mehr further teaches that the patient may also be administered the IL-R antagonist sarilumab (para. 0071), which is pertinent to claim 65.
It would have been prima facie obvious for a person of ordinary skill in the art as of the effective filing date to combine the claims of the ‘947 patent with the teachings of Murphy, Drake, and Kouros-Mehr to arrive at the claimed invention. Murphy teaches that the bispecific antibody claimed by the ‘947 patent is useful for the treatment of prostate cancer in combination with cemiplimab. Drake and Kouros-Mehr further inform the skilled artisan of conventional treatments in the field that may be used in this context, and suitable patient selection parameters. One of ordinary skill could apply the teachings of Drake and Kouros-Mehr with the methods of Murphy and the bispecific antibody of the ‘847 patent to arrive at the claimed invention, with each component of the combination performing its known, usual function, to affect a predictable result.
Conclusion
No claim is allowed.
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/PETER JOHANSEN/Examiner, Art Unit 1644
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