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 .
Priority
Acknowledgment is made of Applicants’ claim for benefit to prior filed US Provisional application 63/162,990 (filed on 03/18/2021).
Election/Restrictions
Applicant’s election without traverse of Group I and SARS-CoV-2, corresponding to claims 1 and 5-10, in the reply filed 24 March 2026 is acknowledged. Claims 2-4 and 11-32 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention or species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 24 March 2026.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1 and 7 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Galili (Cancer Immunol Immunother. 2004 Nov;53(11):935-45.).
Regarding claim 1, Galili discloses irradiated autologous tumor vaccines that are processed to express α-gal epitopes, which are bound to the membrane of the tumor cell, the α-gal epitopes allow for uptake of the tumor cells by APCs, activating the immune response (Abstract; FIG.1, reproduced below).
PNG
media_image1.png
436
517
media_image1.png
Greyscale
Regarding claim 7, Galili discloses irradiated autologous tumor vaccines, which are vaccines made of tumor cells harvested from a patient, cultured for α-gal epitope synthesis, and then irradiated before vaccination of the patient the cells were originally harvested from (Abstract).
Accordingly, Galili anticipated the claimed invention.
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 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 5-6 are rejected under 35 U.S.C. 103 as being unpatentable over Galili as applied to claim 1 and 7 above, and further in view of Corbett, et al. (Nature 586, 567–571 (2020)., NPL-IDS, filed, 09/15/2023, hereinafter “Corbett”).
As discussed above claims 1 and 7 were anticipated by Galili.
Regarding claims 5-6, Galili teaches that the membrane bound antigenic polypeptide is α-gal (Abstract). Galili does not teach that the membrane bound antigenic polypeptide is a SARS-CoV-2 protein. However, Corbett teaches that the SARS-CoV-2 S protein is highly immunogenic and induces both binding and neutralizing antibodies and well as a T cell response (pg. 568 column 2 and figures 2-3).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the invention to have substituted the membrane bound α-gal on the autologous tumor vaccine taught by Galili for the immunogenic S protein from SARS-CoV-2 taught by Corbett. Corbett provides motivation by teaching that the SARS-CoV-2 S protein is highly immunogenic and induces both binding and neutralizing antibodies and a T cell response (Figures 2-3). One of ordinary skill in the art would have had a reasonable expectation of success for substituting the α-gal epitope for the S protein of SARS-CoV-2 because they both are immunogenic polypeptides.
Accordingly, the claimed invention was prima facie obvious to one of ordinary skill in the art before the effective filing date, especially in the absence of evidence to the contrary.
Claims 8-10 are rejected under 35 U.S.C. 103 as being unpatentable over Galili as applied to claim 1 and 7 above, and further in view of Caisova, et al. (Cancers (Basel). 2019 May 11;11(5):654., hereinafter “Caisova”).
As discussed above claims 1 and 7 were anticipated by Galili.
Regarding claims 8-10, Galili does not teach that the vaccine comprises a phagocytosis stimulating agent and an immunostimulatory adjuvant. However, Caisova teaches that intratumoral application of mannan-BAM (phagocytosis stimulating agent), toll-like receptor ligands (immunostimulatory adjuvant), and anri-CD40 antibodies (immunostimulatory adjuvant) which induces an immune response and leads to reduction and eradication of cancerous lesions (Abstract).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the invention to have combined the teachings of Galili for an autologous tumor vaccine and the teachings of Caisova for mannan-BAM, TLR ligands, and Anti-CD40. Caisova provides motivation by teaching that for mannan-BAM, TLR ligands, and Anti-CD40 reduce and completely eradicate cancerous lesions (Abstract). One of ordinary skill in the art would have had a reasonable expectation of success of combing Galili and Caisova because they both teach cancer vaccines.
Accordingly, the claimed invention was prima facie obvious to one of ordinary skill in the art before the effective filing date, especially in the absence of evidence to the contrary.
Conclusion
NO CLAIMS ARE ALLOWED
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Cassandra Senn Grizer whose telephone number is (571)272-2292. The examiner can normally be reached M-Th 0630 - 1700 ET.
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, Thomas J. Visone can be reached at 571-270-0684. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/CASSANDRA SENN GRIZER/ Examiner, Art Unit 1672
/THOMAS J. VISONE/ Supervisory Patent Examiner, Art Unit 1672
Prosecution Insights