DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 1-5, 14-22, 25 and 26 are pending
Claims 3, 5 and 19 have been withdrawn.
Claims 1, 2, 4, 14-18, 20-22, 25 and 26 are currently under examination.
Objections to Specification
The objections to the specification are withdrawn in view of Applicant’s amendments to the Specification.
Objections to Claims
The objections to the Claims are withdrawn in view of Applicant’s amendments to the claims.
35 USC § 112(a) rejections
The rejections of claims 1, 2, 4, 14, 16-18, 21, 22, 25 and 26 for failing to comply with the written description requirement are withdrawn in view of Applicant’s amendments to the claims.
The rejections of claims 1, 2, 4, 14-18, 21, 22, 25 and 26 for failing to comply with the enablement requirement are withdrawn in view of Applicant’s amendments to the claims.
35 USC § 103 rejections withdrawn
The rejection of claim 20 under 35 U.S.C. 103 as being unpatentable over Li et al (US 2015/0080321, published March 19, 2015) in view of Bollard et al (WO 2019/222762, published November 21, 2019), Petit et al (US 2021/0177955, published June 17, 2021, filed November 8, 2018) are withdrawn in view of Applicant’s arguments and amendments to claims 1 and 20.
35 USC § 103 rejections maintained
The rejection of claims 1, 2, 4, 14-18, 21, 22, 25 and 26 under 35 U.S.C. 103 as being unpatentable over Li et al (US 2015/0080321, published March 19, 2015) in view of Bollard et al (WO 2019/222762, published November 21, 2019), Petit et al (US 2021/0177955, published June 17, 2021, filed November 8, 2018) are maintained.
Li disclose the peptides YMFPNAPYL (SEQ ID NO:13) (SEQ ID NO:228 of Li, paragraph 91) and RMFPNAPYL (SEQ ID NO:2) (SEQ ID NO:2 of Li, paragraph 91).
Li disclose the peptide of formula (5) in Table 60
CRMFPNAPYL
I
CYTWNQMNL
Li disclose that the peptides may be used to treat cancer (paragraphs 5-11; 28-33; 37-41). Li discloses that the peptide of formula (5) induced immune response in both HLA-A0201 and HLA-A2402 transgenic mice (paragraphs 268- 275; Fig 14). Li disclose the helper peptide WAPVLDFAPPGASAYGSL that is identical to the MHC class II-restricted peptide consisting of SEQ ID NO:36 (paragraphs 37, 65, 114, 145, 175, 303).
Li does not specifically disclose that the peptide of formula (5) was capable of eliciting an immune response in the context of HLA-A*03 in patients with glioma.
Bollard disclose the treatment of glioma with WT1 peptides in the context of HLA-A*03 (page 40, line 21 to page 44, line 2; page 236, lines 12-31; Table 3).
Petit disclose the treatment of glioma with WT1 peptides in the context of HLA-A*03 (paragraphs 11, 280-283, 317, 327, 409; Table 23; SEQ ID Nos: 1160-169, 197-205)). Petit discloses that two of the peptides shares 90% sequence with the peptides comprising the peptide of formula (5). SEQ ID NO. 160, SEQ ID NO. 167).
One of ordinary skill in the art would have been motivated to apply Bollard and Petit’s method for treating glioma with a WT1 peptide in the context of HLA-A*03 in patients to Li’s method of treating cancer with the peptide of formula (5) because Bollard, Petit and Li disclose the treatment of cancer with WT1 peptides. Li discloses the immunogenicity of the peptide of formula (5) while Petit disclose the treatment of glioma with WT1 peptides consisting of 90% sequence identity with the peptides comprising the peptide of formula (v) in the context of HLA-A*03. It would have been prima facie obvious to combine Li’s method of treating cancer with the peptide of formula (5) with Bollard and Petit’s method for treating glioma with a WT1 peptide in the context of HLA-A*03 in patients. One of ordinary skill in the art would have had a reasonable expectation of success given the immunogenicity of the WT1 peptides and that Li had disclosed the immunogenicity of the peptide of formula (5) and Petit disclosure of the immunogenicity of WT1 peptides consisting of 90% sequence identity with the peptides comprising the peptide of formula (v).
Applicant argues that Ballard et al. and Petit et al. merely mention "HLA-A 03" as one of HLA subtypes. Applicant argues that as demonstrated in the present application, from the prediction on HLA binding and the assays using peripheral blood samples of cancer patients before administration of a cancer peptide vaccine, WT1 126-134 or its modified peptide has not been expected to be effective for treating a cancer of an HLA-A *03:01, HLA-B*l5:0l or HLA-A *02:07-positive subject (paragraph [0216]). Applicant argues that a person skilled in the art would not have been motivated to apply Li's method to HLA-A*03:0l, HLA-B*l5:0l or HLA-A*02:07-positive subjects and would not have a reasonable expectation of success. Applicant argues that the present inventors have demonstrated for the first time that WT1 126- 134 or its modified peptide was useful to treat a cancer of such subjects, by using PBMC samples derived from cancer patients who received a cancer peptide vaccine comprising the compound of the formula (5) and the peptide of SEQ ID NO: 36 ([0220]). Applicant argues that it is an unexpected effect of the claimed invention. Applicant argues that the claims have been significantly limited based on the examples of the present specification such that the claimed invention is commensurate in scope with the unexpected results demonstrated in the present Examples. Applicant argues that the combination of the cited references does not describe what is now claimed, does not provide a motivation to combine the references with a reasonable expectation of success, and the claimed invention provides an advantageous effect that cannot be foreseen based on the disclosures of the cited references.
Applicant’s arguments have been considered but are not persuasive. Li discloses peptides consisting of the amino acid sequence selected from RMFPNAPYL (SEQ ID NO: 2) and YMFPNAPYL (SEQ ID NO: 13) and methods of administering the peptides to a subject. Li discloses that the peptide of formula (5) induced immune response in transgenic mice. As discussed above, Li does not specifically disclose that the peptide of formula (5) was capable of eliciting an immune response in the context of HLA-A*03 in patients with glioma. However, both Bollard and Petit’s disclose methods for treating glioma with WT1 peptides in the context of HLA-A*03 in patients. Furthermore, Bollard, Petit and Li all disclose the treatment of cancer with WT1 peptides. It would have been prima facie obvious to combine Li’s method of treating cancer with the peptide of formula (5) with Bollard and Petit’s method for treating glioma with a WT1 peptide in the context of HLA-A*03 in patients. Furthermore, one of ordinary skill in the art would have a reasonable expectation of success because generating immune responses to WT1 peptides was well known in the art.
With regards to Applicant’s argument of unexpected results, the specification discloses that the administration of the compound of formula (5) from claim 1 along with an acetate of a peptide consisting of the amino acid 5 sequence represented by WAPVLDFAPPGASAYGSL (SEQ ID NO: 36) resulted in the generation of T cells to the peptide WT1126-134. The specification does not disclose that the WT1 peptides RMFPNAPYL (SEQ ID NO: 2) and YMFPNAPYL (SEQ ID NO: 13) were capable of inducing immune responses in a subject with an HLA-A *03:01 HLA haplotype.
MPEP 716.02(d) states
Whether the unexpected results are the result of unexpectedly improved results or a property not taught by the prior art, the “objective evidence of nonobviousness must be commensurate in scope with the claims which the evidence is offered to support.” In other words, the showing of unexpected results must be reviewed to see if the results occur over the entire claimed range. In re Clemens, 622 F.2d 1029, 1036, 206 USPQ 289, 296 (CCPA 1980) (Claims were directed to a process for removing corrosion at “elevated temperatures” using a certain ion exchange resin (with the exception of claim 8 which recited a temperature in excess of 100C). Appellant demonstrated unexpected results via comparative tests with the prior art ion exchange resin at 110C and 130C. The court affirmed the rejection of claims 1-7 and 9-10 because the term “elevated temperatures” encompassed temperatures as low as 60C where the prior art ion exchange resin was known to perform well. The rejection of claim 8, directed to a temperature in excess of 100C, was reversed.). See also In re Peterson, 315 F.3d 1325, 1329-31, 65 USPQ2d 1379, 1382-85 (Fed. Cir. 2003) (data showing improved alloy strength with the addition of 2% rhenium did not evidence unexpected results for the entire claimed range of about 1-3% rhenium); In re Grasselli, 713 F.2d 731, 741, 218 USPQ 769, 777 (Fed. Cir. 1983) (Claims were directed to certain catalysts containing an alkali metal. Evidence presented to rebut an obviousness rejection compared catalysts containing sodium with the prior art. The court held this evidence insufficient to rebut the prima facie case because experiments limited to sodium were not commensurate in scope with the claims.).
Applicant has not demonstrated unexpected results for treating a cancer in an HLA- A*03:01-positive subject comprising administering the WT1 peptides RMFPNAPYL (SEQ ID NO: 2) and YMFPNAPYL (SEQ ID NO: 13) or the peptide of formula (4). In addition, Applicant has not demonstrated unexpected results for treating a cancer in an HLA- A*03:01-positive subject comprising administering the WT1 peptide along with a MHC class II-restricted peptide. Thus, the unexpected results are not commensurate in scope with the present claims.
Summary
Claims 1, 2, 4, 14-18, 21, 22, 25 and 26 stand rejected.
Claims 20 is objected to for being dependent on a rejected claim.
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 extension fee 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.
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/MARK HALVORSON/Primary Examiner, Art Unit 1646
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