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 .
The Group and/or Art Unit of your application has changed. To aid in correlating any papers for this application, all further correspondence regarding this application should be directed to Group Art Unit 1671, Examiner Foley.
Applicant’s amendments have overcome objections to the drawings, specification, claims, and rejections under 35 USC §§ 112(b) and 101.
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 1-3, 6-10, 17, 32, and 33 are rejected under 35 U.S.C. 103 as being unpatentable over Malm et al (Frontiers in Microbiology. 2016 Oct 3;7:1570) and Blyth et al. (USPgPub 2022/0226373A1), both references of record.
The teachings of Malm et al. and Blyth et al. are incorporated herein.
Regarding the newly presented limitations presented in instant claims 6 and 32, Malm et al. teach the measured activity of each T-cell subpopulation is determined using an ELISPOT-γ assay, see the abstract, Table 1, and the “ELISPOT IFN-g Assay” section.
In reply to the rejection of record, applicant argues that while Malm et al. teaches stimulating PBMCs with a pool of synthetic peptides spanning a single antigen, VP1, Malm et al. does not teach expansion using a group of peptides comprising a plurality of norovirus antigens.
Applicant’s arguments and a review of the teachings of Malm et al. have been fully considered, but are found unpersuasive in view of claim recitations. Claim 1 requires “each of the one or plurality of T-cell subpopulations are primed and expanded ex vivo using a group of peptides comprising a plurality of norovirus antigens”. Claim 2 recites “norovirus antigens are chosen from one or a combination of: NS1-2, NS3, NS4, NS5, NS6, NS7,VP1, or VP2, or functional fragments thereof”. Claim 32 requires “a plurality of norovirus antigens comprising a combination of antigens chosen from: VP1...or a functional fragment thereof”. Claim 33 recites “one or plurality of norovirus antigens comprise NS1-2, NS3, NS4, NS5, NS6, NS7, VP1, and VP2, or functional fragments thereof. Therefore, the VLP and plurality of seventy-six individual synthetic peptides designated 99-1 to 99-76 representing the entire 539 amino acid sequence of GII.4- 99 NoV VP1 of Malm et al. are VP1 and functional fragments thereof, as required by the instant claims.
Applicant points to the first full paragraph on page 92, discussing a potential advantage of the instantly claimed invention over the prior art, i.e., to minimize the likelihood of viral escape and may have superior clinical efficacy compared to targeting a single antigen in isolation.
Applicant’s arguments have been fully considered, but are found unpersuasive because Malm et al. identify T cells that are reactive to different VP1 peptides (T Cell Response to NoV VLPs and Capsid Peptide Pool). Blyth et al teaches that the isolated T cell populations are expanded in vitro (i.e., ex vivo) with different viral antigens in paragraphs [0009, 0013, 0037, 0176-0177] and Figures 2, 3, and 5, before being combined in defined ratios (i.e., they are primed and expanded separately from each other) in paragraph [0089] to achieve broad protection in paragraph [0009] and cross-reactive immunization in paragraph [0167]. Finally, Blyth et al teaches a T cell composition comprising at least two subpopulations of T cells wherein the T cells are combined in a defined number or defined ratio in claim 1.
Claims 14-16 remain rejected under 35 U.S.C. 103 as being unpatentable over Malm et al and Blyth et al. and further in combination with Cano et al (Human Immunology 2007, of record).
Applicant argues that the teachings of Cano et al. do not remedy the deficiencies of Malm-Blyth. However, since there are no deficiencies for Cano et al. to cure, the rejection is maintained for reasons of record.
Claim 30 remains rejected under 35 U.S.C. 103 as being unpatentable over Malm et al and Vickers et al. as evidenced by Klein and Sato. All references of record.
Applicant argues that the teachings of Vickers do not remedy the deficiencies of Malm. However, since there are no deficiencies for Vickers to cure, the rejection is maintained for reasons of record.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 SHANON A FOLEY whose telephone number is (571)272-0898. The examiner can normally be reached M-F, generally 5:30 AM-5 PM, flexible.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Allen can be reached at 571-270-3497. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Shanon A. Foley/Primary Examiner, Art Unit 1671
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