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 .
DETAILED ACTION
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on March 4, 2026 has been entered.
Claim Status
Claims 1 has been amended.
Claims 2-7 have been canceled.
Claims 8 and 19-49 were previously canceled.
Claims 1 and 9-18 are pending and under consideration.
Election/Restrictions
Claims 11, 13, and 18 stand withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to non-elected species or inventions. Election was made without traverse in the reply filed February 24, 2025.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. This application is a 371 of PCT/US2020/027681 filed April 10, 2020, which claims priority to US Provisional Application No. PCT/US2020/027681 filed April 10, 2019.
Claim Rejections
In view of the Applicant’s claim amendments, the previous grounds of rejection are withdrawn. The following are new grounds of rejection necessitated by Applicant’s claim amendments. However, Applicant’s arguments relevant to the new grounds of rejection will be addressed below.
Claim Rejections - 35 USC § 112(b)
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.
Claim 10 is rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Claim 10 recites the immunotherapy composition further comprises an antigen presenting cell, carrier, vehicle, diluent, or adjuvant. However, it is unclear what qualifies as a vehicle. Although the claims recite a vehicle, the specifications of the instant application and provisional application do not mention the word vehicle. Therefore, one of ordinary skill could not determine if something is or is not infringing on the scope of the claim. This is of particular importance, as Applicant elected the immunotherapy composition to further comprise a “vehicle”. As such, the word vehicle as used in instant claim 10 will be interpreted as an excipient as described on pg. 6 of the instant specification.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 9-10, 12, and 14-17 are rejected under 35 U.S.C. 103 as being unpatentable over Scheinberg et al. (WO 2017/087857; cited IDS 3/23/2023) (“ '857 ”), in view of Scheinberg et al. (WO 2014/113490; cited IDS 3/23/2023) (“ ‘490 ”).
The instant claims are drawn to an immunotherapy composition comprising a combination of at least seven isolated peptides consisting of: YMFPNAPYL (SEQ ID NO: 124), RSDELVRHHNMHQRNMTKL (SEQ ID NO: 1), PGCNKRYFKLSHLQMHSRKHTG (SEQ ID NO: 2), SGQAYMFPNAPYLPSCLES (SEQ ID NO: 125), NLMNLGATL (SEQ ID NO: 21), WNLMNLGATLKGVAA (SEQ ID NO: 26), and WNYMNLGATLKGVAA (SEQ ID NO: 205), wherein the composition comprises only the seven isolated peptides, wherein the seven peptides are present in equal amounts of 0.1 to 10 parts, further comprising an antigen presenting cell, carrier, vehicle, diluent, or adjuvant, wherein the combination of peptides induce a class I response and a class II response, wherein the combination of peptides induces a CD4+ response, a CD8+ response, or the combination thereof in subjects having HLA*A02, HLA*A03, HLA*B07, HLA*A24, or any combination of two or more.
The ’857 publication teaches immunogenic compositions comprising one or more WT1 peptides (i.e., vaccine, peptide vaccine, WT1 vaccine) for treating, reducing the incidence of, and inducing immune responses against a WT1-expressing cancer [08] (instant claim 1). The peptides may be a combination of native WT1 peptides or modified WT1 peptides and can be administered in the same formulation in combination with a carrier, diluent, or excipient. The peptides can also be administered in combination with an adjuvant [025] (instant claim 10).
Specifically, ‘857 teaches a combination of four peptides: YMFPNAPYL (SEQ ID NO: 124), RSDELVRHHNMHQRNMTKL (SEQ ID NO: 1), PGCNKRYFKLSHLQMHSRKHTG (SEQ ID NO: 2), and SGQA YMFPNAPYLPSCLES (SEQ ID NO: 125) in combination with one or more native or modified WT1 peptides from among those disclosed in WO2014113490, such as, NLMNLGATL (SEQ ID NO: 148), and WNLMNLGATLKGVAA (SEQ ID NO: 153). Five or more peptides may be administered together within the same formulation [030] (instant claims 1, 9).
The immunogenic composition of WT1 peptides provides a method of inducing formation and proliferation of WT1 protein-specific CD8+ and CD4+ lymphocytes [051]. Particularly, WT1 peptides YMFPNAPYL (SEQ ID NO: 124), an HLA class I peptide with a mutated amino acid (R126Y) to stimulate CD8+ responses; SGQAYMFPNAPYLPSCLES (SEQ ID NO: 125), an HLA class II peptide containing an embedded HLA I sequence within the longer peptide to stimulate both CD4+ and CD8+ responses; and RSDELVRHHNMHQRNMTKL (SEQ ID NO: 1) and PGCNKRYFKLSHLQMHSRKHTG (SEQ ID NO: 2), HLA class II peptides that induce CD4+ responses that provide help for long lasting CD8+ T cell responses [0263] (instant claims 14-15). The WT1 peptides bind HLA class II molecules, including HLA-DR molecules, and/or HLA class I molecules, including HLA-A*02 on cancer cells [068, 077] (instant claim 16).
The ‘857 publication further teaches that a WT-1 vaccine comprises 200 micrograms of each peptide in a single 0.5 mL dose [032] (instant claims 12, 17). Thus, ‘857 teaches that all peptides are present in equal amounts, which reads on 1 to 1 parts of each peptide in the composition as recited in the instant claims.
The ‘857 publication does not explicitly teach WT1 peptide WNYMNLGATLKGVAA (SEQ ID NO: 205). However, ‘857 teaches the composition may include any of the peptides disclosed in WO2014113490.
The ‘490 publication teaches the HLA class II DR.B1 binding peptide WNYMNLGATLKGVAA (SEQ ID NO: 11) for use in a vaccine comprising one or more peptides, or at least four different isolated peptides [Table 3, 034, 037]. The ‘490 publication teaches that the NLMNLGATL peptide is a strong epitope for CD8 T cells in the context of HLA-A0201 molecule, while NYMNLGATL peptide, induced CD8 T cell response in HLA-A0201 positive donors. Therefore, ‘490 designed HLA-DRB binding peptides that span these epitopes, which are predicted to be more effective than the single class I epitope in eliciting effective immune response for vaccine design, because CD4 T cells can help CD8 CTL by fully activating DCs through CD40/CD40L signaling as well as by producing IL-2 and IFN-g. Additionally, ‘490 teaches that when T cells were stimulated with two DR.B 1 peptides spanning the NLMNLGATL epitope, they induced CD4 and CD8 T cell responses that were specific for both short and long peptides. More importantly, the responses were directed against B-cell acute lymphoblastic leukemia cells but not control cells [Fig. 5A) [257-260].
The teachings of the ‘857 publication differ from the present invention in that although immunological compositions comprising a combination of WT1 peptides is disclosed for the treatment of cancer is taught, one the seven WT1 peptides recited in the instant claims (WNYMNLGATLKGVAA) is only incorporated by reference . However, given that ‘857 explicitly teaches four of the instantly claimed isolated WT1 peptides (YMFPNAPYL, RSDELVRHHNMHQRNMTKL, PGCNKRYFKLSHLQMHSRKHTG, and SGQAYMFPNAPYLPSCLES) can be combined with one or more peptides taught by ‘490 including NLMNLGATL, WNLMNLGATLKGVAA, and WNYMNLGATLKGVAA, one of ordinary skill in the art would have a reasonable expectation of combining them, especially because ‘857 specifically teaches five or more peptides can be formulated in the same composition to induce CTL killing of tumor cells, including DR.B 1 peptide WNLMNLGATLKGVAA. ‘490 teaches that the combination of two DR.B 1 peptides generated more effective tumor specific killing and specifically teaches WNYMNLGATLKGVAA and WNLMNLGATLKGVAA (also taught by ‘857). Therefore, one of ordinary skill would be motivated to include an additional DR.B 1 peptide such as WNYMNLGATLKGVAA (SEQ ID NO: 205) to the composition taught by ‘857 as the combination results in activation of both CD4+ and CD8+ T cells as evidenced by ‘490.
Section 2144.06 of the MPEP provides guidance as to obviousness of art recognized equivalents for the same purpose. The court has held that it is obvious to combine two elements each of which is taught by the prior art to be useful for the same purpose. No specific teaching or suggestion is needed for combination – the idea of combining them flows logically from their having been individually taught in the prior art as useful for the same purpose. See In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980). As such, the combination of prior art references provided a prima facie case of obviousness.
Response to Arguments
Applicant’s arguments with respect to claims 1, 9-10, 12, and 14-17 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MAUREEN DRISCOLL whose telephone number is (571) 270-0730. The examiner can normally be reached Monday through Friday.
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/MAUREEN VARINA DRISCOLL/
Examiner, Art Unit 1642
/SAMIRA J JEAN-LOUIS/Supervisory Patent Examiner, Art Unit 1642