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
The Amendment filed June 26, 2026 in response to the Non-final rejection of February 27, 2026 is acknowledged and has been entered.
Claims 1-4 were amended or previously presented. Claim 5 was cancelled. Claims 6-10 were newly added.
Claims 1-4 and 6-10 are currently under consideration.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office Action.
Claim Objections
The previous objection to Claim 5 is withdrawn as Claim 5 was cancelled.
Rejections Maintained
Claim(s) 1-3 remain rejected and Claims 6-9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Snyder et al. (US 2017/0051061, published February 23, 2017) for the reasons of record and for the reasons set forth below.
As to claims 1, and 6-7, Snyder et al. teach [0013] a method for treating a leukemia in a subject comprising administering to the subject a therapeutically effective amount of an antibody that specifically binds PD-1H (also known as “VISTA”). Specifically, the reference teaches [0013] that in some embodiments, the antibody or antibody fragment binds to VISTA, thereby modulating or enhancing an immunogenic response to cancer wherein the cancer is a leukemia. Snyder et al. further teaches [0121] that the anti-VISTA compounds and therapies described herein are co-administered with one or more immune checkpoint antibodies, such as, for example, nivolumab, “pembrolizumab”, tremelimumab, ipilimumab, anti-PD-L1 antibody, anti-PD-L2 antibody, anti-TIM-3 antibody, anti-LAG-3v, anti-OX40 antibody and anti-GITR antibody. Pembrolizumab is a PD-1 inhibitor that is also known as MK-3475.
As to claim 2-3, and 8-9, Snyder et al. further teaches [0013] that the leukemia can be acute myeloid leukemia or a myelodysplastic syndrome.
Applicants argue (Response, 06-26-26) that Snyder is an overly broad and general disclosure that does not enable the skilled artisan to envisage the specific combination of elements recited in current claim 1. Applicants further argue that in order for a cited art reference to anticipate a claim, the cited art must provide an enabling disclosure of the claimed subject matter and that the mere naming or description of the subject matter is insufficient; rather, the cited art must demonstrate that the public was in possession of the claimed subject matter before the date of invention. Applicants argue this is the case here- that Synder is a broad and general disclosure directed at novel anti-VISTA antibodies, while at the same time trying to monopolize their use with any cancer therapy- without providing any data relating to any co-administration of the anti-VISTA antibodies with any other therapeutic modality for cancer.
These arguments have been considered but are not found persuasive. Applicants have provided no evidence that the prior art is not enabled. When the reference relied on expressly anticipates or makes obvious all of the elements of the claimed invention, the reference is presumed to be operable. Once such a reference is found, the burden is on applicant to rebut the presumption of operability. In re Sasse, 629 F.2d 675, 207 USPQ 107 (CCPA 1980). On the contrary, Snyder et al. specifically teach VISTA expression on AML cells (Figure 1A-1C), Human VISTA FACS results, showing anti-VISTA antibodies binding to cells expressing human VISTA (Fig. 20A-20F), graphs showing ADCC activity of anti-VISTA antibodies directed against K562 (leukemia cells) (Figures 33-34), and the inhibition of MB49 tumor growth in mice (Figure 25A and 25B, Fig 37) among other specific data. The fact that none of the specific examples demonstrate the co-administration of anti-VISTA antibodies with other common anti-cancer therapeutics such as checkpoint inhibitors does not equate to a non-enabling disclosure as those of skill in the art of cancer therapy often utilize combinations of different anti-cancer agents. Further, patents are relevant as prior art for all they contain. The use of patents as references is not limited to what the patentees describe as their own inventions or to the problems with which they are concerned. They are part of the literature of the art, relevant for all they contain.” In re Heck, 699 F.2d 1331, 1332-33, 216 USPQ 1038, 1039 (Fed. Cir. 1983) (quoting In re Lemelson, 397 F.2d 1006, 1009, 158 USPQ 275, 277 (CCPA 1968)).
Applicants further discuss various passages in Snyder et al. For example, Applicants argue that paragraphs [0106] through [0123] list an innumerable amount of agents that can be utilized according to the disclosure of Snyder. This includes: "peptides, polypeptides, proteins, fusion proteins, nucleic acid molecules, small molecules, mimetic agents, synthetic drugs, inorganic molecules, and organic molecules" [0106]; angiogenesis inhibitors,” etc. Or, “in the one hundred and five (105) page disclosure of Snyder, use of anti-PD-1 antibodies only appear to be mentioned, at best, two times - in paragraphs [0109] and [0121].” These arguments only seek to attack the reference rather than focusing on the rejection of record. Applicants are reminded that "proof of efficacy is not required for a prior art reference to be enabling for purposes of anticipation." Impax Labs. Inc. v. Aventis Pharm. Inc., 468 F.3d 1366, 1383, 81 USPQ2d 1001, 1013 (Fed. Cir. 2006) (citing Rasmusson v. SmithKline Beecham Corp., 413 F.3d 1318, 1326, 75 USPQ2d 1297, 1302 (Fed. Cir. 2005)). See also MPEP § 2122.
Applicants also argue that Snyder does not provide any data that this combination would work, let alone provide any synergistic anti-leukemia effects such as those demonstrated by the present disclosure. In contrast, the present application presents data that demonstrates the specific combination of an anti-PD-1H antibody and an anti-PD-1 antibody confers a synergistic anti- leukemia effect that has not previously been demonstrated or suggested by Snyder. For example, applicants argue that the synergistic anti-leukemia effects demonstrated by the combination of an anti-PD-1 antibody and anti-PD-1H antibody in this application include significantly improved survival outcomes (FIG. 6B) and tumor volume reductions (FIG. 7B) in humanized mouse models as compared to use of an anti-PD-1 antibody or anti-PD-1H antibody alone. This argument has been considered but is not found persuasive because allegations of synergy or a greater than expected result is an evidentiary factor pertinent to the legal conclusion of obviousness. Since the rejection currently being discussed is one of anticipation, the examiner cannot weigh secondary considerations of alleged synergistic outcomes.
Claim 4 remains rejected and Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Snyder et al. (US 2017/0051061, published February 23, 2017) in view of Liu-Dumlao et al. (Curr Oncol Rep (2012) 14:387–394) for the reasons of record. (Claim 10 is identical in scope to Claim 4- wherein the leukemia comprises a Philadelphia chromosome-positive acute lymphoblastic leukemia.
Applicants disagree and state that current claim 4 is dependent upon (and includes each and every feature of ) Applicant's current claim 1 and that Snyder does not anticipate current claim 1 for the reasons stated above. Applicants argue that Liu-Dumlao does not cure the deficiencies of Snyder regarding current independent claim 1 above. As current independent claim 1 is novel and non-obvious in view of the cited prior art (individually or in combination), so is claim 4.
This argument has been considered but is not found persuasive because applicant’s amendment to claim 1 further defined the checkpoint inhibitor as “an antibody that specifically binds PD-1” and this limitation was clearly anticipated by Snyder as set forth above. Thus, Applicant’s arguments have been considered but have not been found persuasive and the rejection is maintained.
No claim is allowed.
Conclusion
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 GARY B NICKOL, Ph.D. whose telephone number is (571)272-0835. The examiner can normally be reached M-F 9AM-5:30PM.
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/GARY B NICKOL/Primary Examiner, Art Unit 1643
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