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 .
This Office action is in response to Applicant’s amendment filed on December 1, 2025 in response to the Office action on July 30, 2025. Claims 1 and 10 have been amended. New claims 20-26 have been added. Claims 1, 3-17 and 20-25 are pending and under examination in this Office action.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on December 19, 2025 has been considered by the examiner.
Claim Rejections - 35 USC § 102
Rejection Claims 10-19 under 35 U.S.C. 102(a)(2) as being anticipated by Cornforth et al. (WO 2013/116505 in IDS on 10/07/24) is withdrawn in view of Applicant’s amendment.
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.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Rejection of Claims 1, 3-17 and 20-25 under 35 U.S.C. 103 as being unpatentable over Cornforth et al. (WO 2013/116505 in IDS on 10/07/24) in view of Nair et al. (Current Protocols in Immunology, November 2012, p. 1-23) and Amanat et al. (Immunity, April 2020, p. 583-589) is maintained.
Cornforth et al. teach an autologous dendritic cell vaccine comprising cancer specific antigens and dendritic cells from the same subject and a method of immunizing an individual comprising administering the autologous dendritic cell vaccine to the individual (see claims 1-36). Cornforth et al. disclose methods of making dendritic cell vaccine comprising collecting blood from an individual, isolating PBMC to generate dendritic cells, adding antigen to the cell culture and harvesting the antigen-loaded mature DCs (see 33-36, paragraphs [00152-00165].
Cornforth et al. do not expressly disclose a personalized vaccine kit.
Nair et al. teach a personalized vaccine kit comprising blood collection supplies, monocyte separation media, dendritic cell differentiation media (see 7.32.2, 7.32.4, 7.32.6).
Nair et al. teach methods of isolating of dendritic cells comprising using blood collection supplies, monocyte separation media, dendritic cell differentiation media (see 7.32.2, 7.32.4, 7.32.6).
Regarding present claim 9, it would have been prima facie obvious to generate a vaccine kit of Cornforth comprising Amanat’s recombinant spike protein of SARS-CoV-2 because Amanat teaches the need for development of vaccines inducing protection against SARS-CoV-2 infection (see the entire document).
Regarding Applicant’s amendment to recite the limitations of “wherein the kit container comprises insulated walls and is capable of serving as an incubator”, it would have been prima facie obvious to have the kit container comprising insulated walls serving as an incubator. It is noted that this recitation is considered an intended use and is not considered limiting.
Regarding new claims 20-25. The limitations of the new claims are obvious as it would have been within the skill of the ordinary artisan to optimize the conditions for incubation of the dendritic cells and the length of incubation and it would have been obvious to provide a contained with a closed system.
It would have been prima facie obvious to arrive at the claimed kit since all component of the kit have been taught in the prior art as discussed above.
Contact Information
Applicant’s amendment necessitated new grounds of rejection present in this Office action. Thus, 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AGNIESZKA BOESEN whose telephone number is (571)272-8035. The examiner can normally be reached on 8:30 - 5:00 PM.
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/AGNIESZKA BOESEN/Primary Examiner, Art Unit 1648
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