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 .
Claims 1-10 and 12-26 are pending and currently under consideration.
Claim Objections
Claim 13 is objected to because of an apparent typographical issue. Claim 13 recites “The method of claim 1, claim 1, wherein….” The following amendment is suggested to address this issue. Proper correction is required. “The method of claim 1, wherein….”Proper correction is required.
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.
Claims 21 and 23-24 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.
Claim 21 recites “…before the administration of the cancer immunotherapy.” There is insufficient antecedent basis for “the administration of the cancer immunotherapy” in the claim.
Claims 23-24 both recite “The method of claim 19, wherein the administered bispecific anti-T cell antigen-binding molecule comprises….” There is insufficient antecedent basis for “the administered bispecific anti-T cell antigen-binding molecule” in the claims.
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.
Claim(s) 1, 2, 4, 5, 9, 10, 12-20, and 22 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kinoshita et al (WO 2017/159287 A1; 9/21/2017; 4/25/23 IDS), as evidenced by Yildizhan et al (Journal of Oncological Sciences, 2018, 4: 134-141).
Kinoshita et al teaches an anticancer drug comprising a bispecific antibody cancer immunotherapeutic that binds to the cancer antigen glypican-3 (GPC3) and an anti-T cell antigen-binding domain that binds a T-cell receptor complex (Abstract, in particular). Kinoshita et al further teaches the bispecific antibody comprises mutations the reduce the affinity for Fcg receptor, which is expected to avoid cytokine release syndrome (see fourth paragraph before Table 12 of translation of Kinoshita et al at patents.google.com, in particular). As evidenced by Yildizhan et al, cytokine release syndrome (CRS) is caused by release of cytokines from T and B lymphocytes, natural killer cells, monocytes and macrophages (left column on page 134, in particular). Kinoshita et al further teaches the bispecific antibody wherein the anti-T cell antigen-binding domain that binds a T-cell receptor complex binds CD3 (see section marked “[1]” in the translation of Kinoshita et al at patents.google.com, in particular). Kinoshita et al further teaches a combination therapeutic method of treating cancer wherein the bispecific antibody and an other anticancer agent is administered to an individual (first two paragraphs under “Combination Therapy and Pharmaceutical Compositions” portion of translation of Kinoshita et al at patents.google.com, in particular). Kinoshita et al further teaches a combination therapeutic method wherein the other anticancer agent is the angiogenesis inhibitor bevacizumab (see claims 8-9 and 26th paragraph under “Combination Therapy and Pharmaceutical Compositions” portion of translation of Kinoshita et al at patents.google.com, in particular). Kinoshita et al further teaches said method wherein the other anticancer agent is administered simultaneously with the bispecific antibody, before the bispecific antibody, or after the bispecific antibody (see claim 9 and the sections marked “[9]” and “[10]” in the translation of Kinoshita et al at patents.google.com, in particular). Kinoshita et al further teaches said method wherein the portion of the bispecific antibody that binds cancer antigen GPC3 targets cancer tissue containing GPC3 (see two paragraphs above the section marked “[1]” in the translation of Kinoshita et al at patents.google.com, in particular).
Claim Rejections - 35 USC § 102
Claim(s) 15-18 and 25 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kemeny et al (Oncology, 2011, 80: 153-159), as evidenced by Yildizhan et al (Journal of Oncological Sciences, 2018, 4: 134-141).
Kemeny et al teaches a method of treating a subject with cancer comprising administering bevacizumab and the corticosteroid dexamethasone to the subject (Abstract, in particular). Said method is a method for preventing cytokine release syndrome (CRS) because dexamethasone prevents CRS, as evidenced by the first paragraph on page 140 of Yildizhan et al.
Claim Rejections - 35 USC § 103
Claim(s) 1-10, 12-20, 22, 25, and 26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kinoshita et al (WO 2017/159287 A1; 9/21/2017; 4/25/23 IDS) as applied to claims 1, 2, 4, 5, 9, 10, 12-20, and 22 above, and further in view of Yildizhan et al (Journal of Oncological Sciences, 2018, 4: 134-141).
Teachings of Kinoshita et al are discussed above.
Kinoshita et al does not specifically teach the method of Kinoshita et al wherein bevacizumab administered before the bispecific antibody is administered on the same day as the bispecific antibody. Further, Kinoshita et al does not specify whether a corticosteroid is administered. However, these deficiencies are made up in the teachings of Yildizhan et al.
Yildizhan et al teaches cytokine release syndrome (CRS) is caused by release of cytokines from T and B lymphocytes, natural killer cells, monocytes and macrophages (left column on page 134, in particular). Yildizhan et al further teaches CRS causes uncontrolled endothelial damage resulting in a systemic inflammatory response with multiple organ dysfunction and even death (left column on page 134, in particular). Yildizhan et al further teaches interaction of therapeutic antibodies with Fcg receptor on macrophages contributes to CRS (right column on page 134, in particular). Yildizhan et al further teaches that, while prophylactic use of corticosteroids should be avoided (right column on page 139, in particular), administration of tocilizumab +/- corticosteroid is “required” when a patient exhibits Grade 3 symptoms of CRS (Table 2, in particular). Yildizhan et al further teaches dexamethasone as a corticosteroid for treating CRS (left column on page 139, in particular).
One of ordinary skill in the art would have been motivated, with a reasonable expectation of success, to treat a subject with cancer by performing a combined method comprising the method of Kinoshita et al wherein the subject is administered a bispecific antibody cancer immunotherapeutic that binds to the cancer antigen glypican-3 (GPC3) and an anti-T cell antigen-binding domain that binds a T-cell receptor complex of Kinoshita et al before, simultaneously with, or after administering bevacizumab of Kinoshita et al wherein administration is performed on the same day in an effort to minimize the time the subject has to commute to a treatment facility.
Further, one of ordinary skill in the art would have been motivated, with a reasonable expectation of success, to perform said combined method wherein the subject is administered a corticosteroid if Grade 3 symptoms of CRS develops after administering the bispecific antibody and bevacizumab because Yildizhan et al teaches that, while prophylactic use of corticosteroids should be avoided (right column on page 139, in particular), administration of tocilizumab +/- corticosteroid is “required” when a patient exhibits Grade 3 symptoms of CRS (Table 2, in particular) and Yildizhan et al further teaches dexamethasone as a corticosteroid for treating CRS (left column on page 139, in particular). Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art, absent unexpected results.
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 1-10, 12-20, 22, 25, and 26 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 12 of U.S. Patent No. 11072666 B2 in view of Kinoshita et al (WO 2017/159287 A1; 9/21/2017; 4/25/23 IDS) and Yildizhan et al (Journal of Oncological Sciences, 2018, 4: 134-141). The pending claims differ from patent claim 12 in that the pending claims require preventing and/or alleviating and/or treating cytokine release syndrome and/or cytokine release, administering the bispecific antibody and the VEGF inhibitor at various times or orders, optionally administering a corticosteroid, and wherein the bispecific antibody optionally having reduced binding activity towards Fcg receptor. However, one would be motivated to perform the patent method wherein the bispecific antibody comprises mutations the reduce the affinity for Fcg receptor, which is expected to avoid cytokine release syndrome (see fourth paragraph before Table 12 of translation of Kinoshita et al at patents.google.com, in particular). As evidenced by Yildizhan et al, cytokine release syndrome (CRS) is caused by release of cytokines from T and B lymphocytes, natural killer cells, monocytes and macrophages (left column on page 134, in particular). Further, one would be motivated to perform said method wherein the administered a bispecific antibody is administered before, simultaneously with, or after administering bevacizumab of the patent claim wherein administration is performed on the same day in an effort to minimize the time the subject has to commute to a treatment facility. Further, one of ordinary skill in the art would have been motivated, with a reasonable expectation of success, to perform said combined method wherein a corticosteroid is administered if Grade 3 symptoms of CRS develops after administering the bispecific antibody and bevacizumab because Yildizhan et al teaches that, while prophylactic use of corticosteroids should be avoided (right column on page 139, in particular), administration of tocilizumab +/- corticosteroid is “required” when a patient exhibits Grade 3 symptoms of CRS (Table 2, in particular) and Yildizhan et al further teaches dexamethasone as a corticosteroid for treating CRS (left column on page 139, in particular).
Conclusion
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/SEAN E AEDER/Primary Examiner, Art Unit 1642