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, 2, 4, 8, 10, 103, 112, and 116 are pending and currently under consideration.
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 1, 2, 4, 10, 103, 112, and 116 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 1 recites “a cancer patient population” followed by instances of “the cancer patient.” There is insufficient antecedent basis for “the cancer patient” in the claim.
Claim 1 recites “…detecting…components selected from the group consisting of…” followed “…quantitating the measurement of the level of components selected from” a list of cell types. There is insufficient antecedent basis for “the measurement of the level of components” in the claim.
The last line of claim 1 recites “…of the cells.” There is insufficient antecedent basis for “the cells” in the claim.
Step “(c)” of claim 2 recites “…of the cells.” There is insufficient antecedent basis for “the cells” in the claim.
Claim 4 recites two instances of “the biological sample.” There is insufficient antecedent basis for “the biological sample” in the claim. Further, the last line of claim 4 appears to be missing a step correlating a result to efficacy. Such a missing step renders the claim as being incomplete for omitting essential steps, such omission amounting to a gap between the steps. See MPEP § 2172.01.
The preamble of claim 10 recites “a cancer patient population” followed by instances of “the cancer patient.” There is insufficient antecedent basis for “the cancer patient” in the claim.
The first “(a)” portion of claim 10 recites “in a biological sample” that is from a cancer patient and the first step “(c)” of the claim recites a comparison of expression and/or level of PVRIG and/or PVRL2 in the biological sample from the cancer patient to a “control or a patient that does not have detectable levels of PVRIG and/or PVRL2 in the biological sample.” The metes-and-bounds of the claim are unclear because it is unclear what is meant by a biological sample that is from a cancer patient that is also a biological sample (“the biological sample”) that is from a control or patient used in a comparison.
The preamble of claim 103 recites “a cancer patient population” followed by “the cancer patient.” Part “(b)” of claim 103 also recites “…quantitating the measurement of the level of DNAM-1 and/or PVRIG….”There is insufficient antecedent basis for “the cancer patient” and “the measurement of the level of DNAM-1 and/or PVRIG” in the claim.
Claim 112 recites two instances of “in the biological sample.” There is insufficient antecedent basis for “the biological sample” in the claim.
The preamble of claim 116 recites “a cancer patient population” followed by instances of “the cancer patient.” There is insufficient antecedent basis for “the cancer patient” in the claim.
The first “(a)” portion of claim 116 recites “in a biological sample” that is from a cancer patient and the first step “(c)” of the claim recites a comparison of expression and/or level of PVRIG and/or DNAM-1 in the biological sample from the cancer patient to a “control or a patient that does not have detectable levels of PVRIG and/or DNAM in the biological sample.” The metes-and-bounds of the claim are unclear because it is unclear what is meant by a biological sample that is from a cancer patient that is also a biological sample (“the biological sample”) that is from a control or patient used in a comparison.
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.
Claims 1, 2, 4, 8, 10, 103, 112, and 116 are rejected under 35 U.S.C. 103(a) as being unpatentable over Whelan et al (Cancer Immunol Res, 2019, 7(2): 257-268; 1/17/25 IDS).
Whelan et al teaches PVRIG are receptors on CD8+ T-cells from peripheral blood and antagonizing PVRIG checkpoint receptor with an anti-PVRIG antibody (COM701) increases CD8+ T-cell cytokine production and cytotoxic activity against tumor cells (first paragraph of left column on page 258 and Figure 1, particular). Whelan et al further teaches quantifying and detecting the amount of CD8+ T-cells that express PVRIG and that the amount of CD8+ T-cells that express PVRIG expression varies in different cancer patients (Figure 4, in particular). Supplemental Figure S4A of Whelan et al further teaches detecting PVRIG expression on various populations of CD8+ T cells (naïve CD8+ T cells, central memory (CM) CD8+ T-cells, early memory (EM) CD8+ T-cells, and terminally differentiated effector memory (TEMRA) CD 8+ T-cells) and found PVRIG was expressed more commonly on EM and TEMRA memory cells.
Whelan et al does not specifically teach treating a cancer patient with the anti-PVRIG antibody. However, one of ordinary skill in the art would have been motivated, with a reasonable expectation of success, to perform a method of identifying and therapeutically treating cancer patients comprising detecting and quantitating the amount of PVRIG expression on CD8+ T-cells obtained from peripheral blood from the patients as taught by Whelan et al, correlating any presence of (any presence above 0% of T-cells) CD8+ T-cells expressing PVRIG with efficacy/responsiveness to treatment with anti-PVRIG antibody, and administering an anti-PVRIG antibody (COM701) to patients with CD8+ T-cells expressing the checkpoint receptor PVRIG in an effort to increase cytotoxic activity against tumor cells of the patients because Whelan et al teaches PVRIG are receptors on CD8+ T-cells from peripheral blood and that antagonizing PVRIG checkpoint receptor on the CD8+ cells with an anti-PVRIG antibody (COM701) increases cytotoxic activity against tumor cells (first paragraph of left column on page 258 and Figure 1, particular) and quantitating PVRIG-expressing CD8+ cells of a cancer patient prior to administering the anti-PVRIG antibody has the benefit of confirming the presence of the target of anti-PVRIG antibody (PVRIG) prior to administering anti-PVRIG antibody as a therapeutic.
Further, one of ordinary skill in the art would have been motivated, with a reasonable expectation of success, to perform said method wherein the CD8+ T-cells on which PVRIG is detected are most predictably early memory (EM) or terminally differentiated effector memory (TEMRA) CD 8+ T-cells because Figure S4A of Whelan et al teaches detecting PVRIG expression on various populations of CD8+ T cells (naïve CD8+ T cells, central memory (CM) CD8+ T-cells, early memory (EM) CD8+ T-cells, and terminally differentiated effector memory (TEMRA) CD 8+ T-cells) and found PVRIG was expressed more commonly on EM and TEMRA memory cells.
This is an example of some teaching, suggestion, or motivation in the prior art that would have led one or ordinary skill to modify the prior art reference teachings to arrive at the claimed invention. See MPEP 2143. 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
A rejection based on double patenting of the “same invention” type finds its support in the language of 35 U.S.C. 101 which states that “whoever invents or discovers any new and useful process... may obtain a patent therefor...” (Emphasis added). Thus, the term “same invention,” in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co., 151 U.S. 186 (1894); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA 1957).
A statutory type (35 U.S.C. 101) double patenting rejection can be overcome by canceling or amending the claims that are directed to the same invention so they are no longer coextensive in scope. The filing of a terminal disclaimer cannot overcome a double patenting rejection based upon 35 U.S.C. 101.
Claim 1 is provisionally rejected under 35 U.S.C. 101 as claiming the same invention as that of claim 1 of copending Application No. 18/185632 (reference application). This is a provisional statutory double patenting rejection since the claims directed to the same invention have not in fact been patented.
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 2, 4, 8, 10, 103, 112, and 116 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 7 and 12 of copending Application No. 18/185632 view of Whelan et al (Cancer Immunol Res, 2019, 7(2): 257-268; 1/17/25 IDS). Although the claims at issue are not identical, they are not patentably distinct from each other because both the instant claims and the copending claims are drawn to methods of characterizing and treating the same patient population with the same treatment. Instant claim 2 recites a correlating step not recited by the copending application; however, it would be obvious to correlate any level (above 0%) of the CD8+ T cells that express PVRIG detected by the copending method with efficacy of anti-PVRIG antibody treatment because Whelan et al teaches antagonizing PVRIG checkpoint receptor on the CD8+ cells with an anti-PVRIG antibody (COM701) increases cytotoxic activity against tumor cells (first paragraph of left column on page 258 and Figure 1, particular). Further, one of ordinary skill in the art would have been motivated, with a reasonable expectation of success, to perform said method wherein the CD8+ T-cells on which PVRIG is detected by the copending method are most predictably early memory (EM) or terminally differentiated effector memory (TEMRA) CD 8+ T-cells because Figure S4A of Whelan et al teaches detecting PVRIG expression on various populations of CD8+ T cells (naïve CD8+ T cells, central memory (CM) CD8+ T-cells, early memory (EM) CD8+ T-cells, and terminally differentiated effector memory (TEMRA) CD 8+ T-cells) and found PVRIG was expressed more commonly on EM and TEMRA memory cells.
This is a provisional nonstatutory double patenting rejection.
Conclusion
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/SEAN E AEDER/ Primary Examiner, Art Unit 1642