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 147-167 are pending and currently under consideration.
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) 147-167 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hegde et al (WO 2018/160841 A1; 9/7/18; 11/29/22 IDS).
Hegde et al teaches a method of treating an individual having kidney cancer comprising determining (i) the expression level of CXCL8 (same as “IL8”) and (ii) CD8A, GZMA, GZMB, and PRF1 (a “Teff signature”) in a sample from the individual, wherein an expression level of CXCL8 in the sample that is below a reference expression level and levels of CD8A, GZMA, GZMB, and PRF1 above a reference expression level identifies the individual as one who may benefit from an anti-cancer therapy comprising a VEGF antagonist and a PD-L1 axis binding antagonist (lines 13-25 on page 2, in particular). Hegde et al further teaches said method wherein the patient who may benefit from the anti-cancer therapy is administered an effective amount of the anti-cancer therapy (lines 23-26 on page 3, in particular). Hegde et al further teaches said method wherein the individual is human (line 34 on page 9, in particular). Hegde et al further teaches said method wherein the reference level of CXCL8 is a median expression level of CXCL8 determined in a population of patients having kidney cancer (lines 31-33 on page 7, in particular). Hegde et al further teaches said method wherein the PD-L1 axis binding antagonist of the anti-cancer therapy is atezolizumab (line 30 on page 8, in particular), which comprises the CDRs of instant SEQ ID NOs: 19-24, comprises instant SEQ ID NOs:4 and 25, and comprises the sequences of SEQ ID NOs:76-72 of Hegde et al (page 147, in particular). Hegde et al further teaches said method wherein the VEGF antagonist is bevacizumab (line 16 on page 8, in particular). Hegde et al further teaches said method wherein the sample is a tumor tissue sample comprising tumor-infiltrating immune cells (lines 7-8 on page 8, in particular) such as granulocyte (granulocytes are a type of myeloid cells; see line 34 on page 36, in particular), a whole blood sample (lines 4-5 on page 8, in particular), or an FFPE sample (line 9 on page 8, in particular). Hegde et al further teaches said method wherein the sample is obtained prior to administering the anti-cancer therapy (lines 26-34 on page 5, in particular). Hegde et al further teaches said method wherein the kidney cancer has not been previously treated, wherein the kidney cancer is RCC, and wherein the kidney cancer is mRCC (lines 11-13 on page 8, in particular). Hegde et al further teaches said method wherein the expression level is mRNA expression level determined by RNA-seq (lines 35-39 on page 7, in particular). Hegde et al further teaches said method wherein the expression level is protein expression level determined by ELISA (lines 1-4 on page 8, in particular). Hegde et al further teaches said method wherein the expression level is a normalized expression level to housekeeping genes (lines 8-10 on page 31, in particular) and identifies TMEM55B, VPS33B, TBP, and TUBB as housekeeping genes (lines 35-36 on page 172, in particular).
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 147-167 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of U.S. Patent No. 12078638 B2 in view of Hegde et al (WO 2018/160841 A1; 9/7/18). The patent claims differ from the instant claims in that the patent claims do not recite the individual treated with a combination of bevacizumab and atezolizumab based on expression levels of genes of the instant claims is “human”, the tumor infiltrating immune cells of the patent claims include myeloid cells, that the mRNA levels of the patent claims are determined by a method such as “RNA-seq”, detecting “GZMA” and “GZMB”, or that the normalized expression levels are “normalized against the mRNA expression levels of TMEM55B, VPS33B, TBP and TUBB.” However, it would be obvious to perform the patented method wherein the individual treated with a combination of bevacizumab and atezolizumab based on expression levels of genes of the instant claims is “human”, the tumor infiltrating immune cells of the patent claims include myeloid cells, that the mRNA levels of the patent claims are determined by a method such as “RNA-seq”, detecting “GZMA” and “GZMB”, and that the normalized expression levels are “normalized against the mRNA expression levels of TMEM55B, VPS33B, TBP and TUBB” because Hegde et al teaches the patented method wherein the individual treated with a combination of bevacizumab and atezolizumab based on expression levels of genes of the instant claims is “human”, the tumor infiltrating immune cells of the patent claims include myeloid cells, that the mRNA levels of the patent claims are determined by a method such as “RNA-seq”, detecting “GZMA” and “GZMB”, and that the normalized expression levels are “normalized against the mRNA expression levels of TMEM55B, VPS33B, TBP and TUBB” (see above 35 U.S.C. 102(a)(1) rejection).
Claims 147-167 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of U.S. Patent No. 11402382 B2 in view of Hegde et al (WO 2018/160841 A1; 9/7/18). The patent claims differ from the instant claims in that the patent claims do not recite the individual treated with a combination of bevacizumab and atezolizumab based on expression levels of genes of the instant claims is “human”, the tumor infiltrating immune cells of the patent claims include myeloid cells, that the mRNA levels of the patent claims are determined by a method such as “RNA-seq”, detecting “GZMA” and “GZMB”, or that the normalized expression levels are “normalized against the mRNA expression levels of TMEM55B, VPS33B, TBP and TUBB.” However, it would be obvious to perform the patented method wherein the individual treated with a combination of bevacizumab and atezolizumab based on expression levels of genes of the instant claims is “human”, the tumor infiltrating immune cells of the patent claims include myeloid cells, that the mRNA levels of the patent claims are determined by a method such as “RNA-seq”, detecting “GZMA” and “GZMB”, and that the normalized expression levels are “normalized against the mRNA expression levels of TMEM55B, VPS33B, TBP and TUBB” because Hegde et al teaches the patented method wherein the individual treated with a combination of bevacizumab and atezolizumab based on expression levels of genes of the instant claims is “human”, the tumor infiltrating immune cells of the patent claims include myeloid cells, that the mRNA levels of the patent claims are determined by a method such as “RNA-seq”, detecting “GZMA” and “GZMB”, and that the normalized expression levels are “normalized against the mRNA expression levels of TMEM55B, VPS33B, TBP and TUBB” (see above 35 U.S.C. 102(a)(1) rejection).
Conclusion
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/SEAN E AEDER/Primary Examiner, Art Unit 1642