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 .
Election/Restrictions
Applicant's species election with traverse of SEQ ID NO: 1 in the reply filed on 5/29/2026 is acknowledged. The traversal is on the ground(s) that the shared technical feature is not taught by the prior art under PCT Rule 13. This is not found persuasive because 1) the election requirement was directed towards a species election and not a restriction requirement, 2) a teaching of the special technical feature in the prior art is not the only basis for finding lack of unity of invention, and 3) Applicant’s arguments do not address the specific rationale of record that the polypeptides of claim 1 are not regarded as being of similar nature because: (1) the alternatives do not all share a common structure and (2) the alternatives do not all belong to a recognized class of chemical compounds; see M.P.E.P. § 1850(III)(B).
Nevertheless, in view of the search results the species election requirement is withdrawn.
Claims 1-5 are under consideration on the merits.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-5 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for contacting T cell(s) with a composition comprising polypeptides consisting of SEQ ID NOs 1-71 and further requiring an additional/second step of contacting the T cell(s) with a composition comprising polypeptides consisting of SEQ ID NOs 1-71, does not reasonably provide enablement for one or more polypeptides comprising SEQ ID NO: 1-71. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the invention commensurate in scope with these claims.
The factors to be considered in determining whether undue experimentation is required are summarized in In re Wands, 858 F.2d 731, 737, 8 USPQd 1400, 1404 (Fed. Cir. 1988) (a) the breadth of the claims; (b) the nature of the invention; (c) the state of the prior art; (d) the level of one of ordinary skill; (e) the level of predictability in the art; (f) the amount of direction provided by the inventor; (g) the existence of working examples; and (h) the quantity of experimentation needed to make or use the invention based on the content of the disclosure. While all of these factors are considered, a sufficient number are discussed below so as to create a prima facie case.
The method of claim 1 appears to be novel, as SEQ ID NOs 1-71 are not taught in the prior art. de Groot (WO 2021/163398; provided in the IDS date 5/29/2026) is likely the closest prior art and teaches T cell epitope peptides derived from SARS-Cov2 proteins (page 30, line 21 through page 31, line 8) and which are capable of stimulating CD4+ and/or CD8+ T cells immune response to SARS-CoV2 (page 58, lines 1-24). However, epitope peptide stimulation of T cells is unpredictable as from a group of 32 putative/predicted T cell epitope peptides, SARs-Cov2 naïve T cells only recognized 1-2 peptides out of 32 (i.e. only about 3-6% success rate) but SARs-Cov2 convalescent T cells recognize 21/32 peptides (i.e. about a 66% success rate (Fig. 8B and 8C, and page 167, line 1 through page 168, line 3).
In the unpredictable arts, more guidance is needed to satisfy the enablement requirement, see M.P.E.P. § 2164.03 and In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970) and Amgen Inc. v. Chugai Pharmaceutical Co. Ltd., 927 F.2d 1200, 1212, 18 USPQ2d 1016, 1026 (Fed. Cir.), cert. denied, 502 U.S. 856 (1991). Also see M.P.E.P. § 2164.03. In this case, de Groot provides for a prima facie case for unpredictability.
While the specification clearly disclosures SEQ ID NOs 1-71 at Tables 1 and 2 and are taught as being derived from SARS-CoV2 peptide epitopes, Example 2 appears to group all of the claimed SEQ IDs as “CRAG” and so does not clearly discriminate which SEQ IDs or combinations of any particular SEQ IDs out of SEQ ID NOs 1-71 as claimed are and are not capable of stimulating T cells. Notwithstanding the extremely small magnitude of the disclosed effect of CRAG peptides set forth in Fig. 1, the disclosed methods recite an additional/second step of contacting the T cell(s) with the CRAG peptides and given the unpredictability set forth by de Groot it is unclear if said CRAG peptides would be capable of stimulating the T cells in the claimed method without an additional restimulation step.
Therefore, the level of experimentation must be held as undue because 1) de Groot makes clear that epitope peptide stimulation of T cell is unpredictable in that the peptide sequence itself does not predictably correlate with functional stimulation of T cells obtained from various sources, and 2) the specification does not clearly discriminate which SEQ IDs or combinations of any particular SEQ IDs out of SEQ ID NOs 1-71 are and are not capable of stimulating T cells. A person skilled in this art would be left to empirically screen each of SEQ ID NOs 1-71 individually and also the 7171 possible combinations of SEQ ID NOs 1-71 with and without an additional/second step of contacting the T cells with each of SEQ ID NOs 1-71 individually and also the 7171 possible combinations of SEQ ID NOs 1-71 for operability without any reasonable guidance from the prior art and/or the disclosure to clearly identify operable vs. inoperable embodiments (i.e. the claimed SEQ IDs). See M.P.E.P. § 2164.08(b), in that claims reading on significant numbers of inoperative embodiments would render claims nonenabled when the specification does not clearly identify the operative embodiments and undue experimentation is involved in determining those that are operative. Atlas Powder Co. v. E.I. duPont de Nemours & Co., 750 F.2d 1569, 1577, 224 USPQ 409, 414 (Fed. Cir. 1984); In re Cook, 439 F.2d 730, 735, 169 USPQ 298, 302 (CCPA 1971).
As such, the claims can only be reasonably enabled for the combination of all of SEQ ID NOs 1-71 and not the broader embodiment of one or more polypeptide(s) comprising SEQ ID NOs 1-71 and with a as set forth in independent claim 1, and requiring an additional/second step of contacting the T cell(s) with a composition comprising polypeptides consisting of SEQ ID NOs 1-71.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SEAN C BARRON whose telephone number is (571)270-5111. The examiner can normally be reached 7:30am-3:30pm EDT/EST (M-F).
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/Sean C. Barron/Primary Examiner, Art Unit 1653
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