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 63/121,164 (filed on 12/03/2020).
Response to Amendment
The amendment filed 22 June 2026 in which claims 5-6, 8, 15, 22, 27, 30-31, 58, 62, 69, 72, 81, 122, 124, 128-129, and 131 were amended has been entered.
Election/Restrictions
Applicant’s election without traverse of Group II, corresponding to claims 2-3, 9, and 11, and species election of SEQ I DNO: 14,915 in claim 128, in the reply filed 22 June 2026 is acknowledged. Applicant amended claims 5-6, 8, 15, 22, 27, 30-31, 58, 62, 69, 72, 81, 122, 124, 128-129, and 131 to be dependent on claim 2 and be included in the restriction selection. Claims 1, 4, and 212 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 22 June 2026.
Specification
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Drawings
The drawings are objected to because Figs. 2B-2C do not have a labeled Y-axis. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Rejections - 35 USC § 112
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.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 7-8, 72, 124, and 128-129 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
In regard to claim 7, administering a dose before the first dose just makes the administered dose the first dose when the compositions are the same, it is unclear then how a dose could be administered prior to the first dose.
For the purposes of compact prosecution and applying prior art, claim 7 is being interpreted as any set of more than three doses.
In regard to claim 8, administering doses between the 1st and 2nd cannot be administered without creating new 1st and 2nd doses.
For the purposes of compact prosecution and applying prior art, claim 8 is being interpreted as any administration of at least 2 doses.
Claim 72 recites the limitation "the at least one alternation" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim because the alternation is not recited previously in the claim or in claim 2 for which claim 72 is dependent on and it is unclear what the alteration entails as it is not clearly defined.
For the purposes of compact prosecution and applying prior art, claim 72 is being interpreted as dependent on claim 69.
Claims 124 and 128 recite the limitation “the epitope-encoding nucleic acid sequence” in line 1 (124) and lines 1-2 (128). There is insufficient antecedent basis for this limitation because the epitope-encoding nucleic acid sequence is not recited previously in the claim or in claim 2 for which claims 124 and 128 are dependent on and it is unclear what the sequence entails as it is not clearly defined.
For the purposes of compact prosecution and applying prior art, claims 124 and 128 are being interpreted as dependent on claim 31.
Claim 129 recites the limitation “the at least one antigen-encoding nucleic acid sequence” in lines 1-2. There is insufficient antecedent basis for this limitation because the at least one antigen-encoding nucleic acid sequence is not recited previously in the claim or in claim 2 for which claim 129 is dependent on and it is unclear what the sequence entails as it is not clearly defined.
For the purposes of compact prosecution and applying prior art, claim 129 is being interpreted as dependent on claim 31.
It is noted any interpretation of the claims set forth above does not relieve Applicant of the responsibility of responding to this rejection. If the actual interpretation of the claims is different than that posited by the Examiner, additional rejection and art may be readily applied in a subsequent final Office action.
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 2-3, 5-9, 11, 15, 22, 27, 30-31, 44, 58, 62, 69, 72, 76, 81, 122, 124, 128-129, and 131 are rejected under 35 U.S.C. 103 as being unpatentable over Yelensky, et al. (WO 2019226941, FOR-IDS, filed, 06/22/2026, hereinafter “Yelensky”) and further in view of Capone, et al. (NPJ Vaccines. 2020 Oct 12;5:94., NPL-IDS, filed, 06/22/2026, hereinafter “Capone”) as evidenced by Hartnell, et al. (Front Immunol. 2019 Jan 18;9:3175., hereinafter “Hartnell”).
Regarding claims 2-3 and 8, Yelensky teaches a method for delivering a composition (¶0020) comprising a chimpanzee adenovirus (ChAdV) (¶0016) vector to a subject (¶0020). Yelensky further teaches that the method comprises administering a plurality of doses (¶00402). Yelensky does not explicitly teach that ChAdV-specific neutralizing antibodies (nAbs) are determined to be below a second threshold before administration of a second dose. However, Yelensky does teach that that the levels of immunity can be monitored to determine the need for a booster dose (¶00379) and Capone teaches that when a boost inoculation is performed and the time period between prime and boost is short and the nAb titer is high so the boost to nAbs cannot be obtained wherein if the interval between prime and boost is long and the nAb titer is low, the vaccine will boost nAb titers (pg. 2 column 1 - pg. 3 column 2).
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 Yelensky for a method of administering multiple doses of a ChAdV vector to a subject including using immunity levels to determine the need of boosters with the teachings of Capone for the appropriate time period between doses. Capone provides motivation by teaching that booster doses only successfully boost nAb titers when titers are low (pg. 2 column 1 - pg. 3 column 2). One of skill in the art would have a reasonable expectation of success in combining Yelensky and Capone because they both teach ChAdV vectors administered in multiple doses.
Regarding claim 5, Yelensky teaches that the first dose is a priming dose (¶00402).
Regarding claims 6-7, Capone teaches administering four doses of a ChAdV composition (Arm A3, Fig. 2A).
Regarding claim 9, Yelensky and Capone do not explicitly teach the neutralizing threshold. However, a predetermined neutralizing threshold is required to determine if nAb titers are low enough to produce the necessary immune response after a booster dose, as taught by Yelensky (¶00379) and Capone (pg. 2 column 1 - pg. 3 column 2). This is an optimizable parameter that can be altered based on many factors including number of doses, ChAdV virus, vaccine dose, etc. Capone teaches that this threshold should be low enough to allow the booster dose to induce an nAb response (pg. 2 column 1 - pg. 3 column 2). Routine optimization of the optimal nAb titer before administration of a second composition dose would lead to the creation of a neutralizing threshold because Capone teaches that nAb titers should be low to allow for a second composition to effectively boost nAbs (pg. 2 column 1 - pg. 3 column 2), routine testing and optimization would lead to an ideal number, that once crossed would offer optimal conditions for administering the second dose. The person of ordinary skill in the art would have found it obvious to optimize the neutralization threshold because Capone teaches that administering the second composition too early prevents the necessary boost in nAb titers (pg. 2 column 1 - pg. 3 column 2).
Regarding claim 11, Capone teaches the method used by Hartnell to determine the neutralizing antibody titer. Hartnell evidences a ChAdV neutralizing assay that comprises contacting SEAP-expressing ChAds with serial dilution of serum from vaccinated volunteers and then added to cells for a neutralization assay (pg. 4 column 1). Results were compared to virus and cells alone with no serum (pg. 4 column 1).
Regarding claim 15, Yelensky teaches that the ChAdV vector encodes at least one antigen (¶0016).
Regarding claim 22, Yelensky teaches that the composition is administered intramuscularly, intradermally, intravenously, or subcutaneously (¶0092).
Regarding claim 27, Yelensky teaches that adding an immune modulator is only used in some aspects, meaning that the method does not include the administration of an immune modulator (¶0085).
Regarding claim 30, Yelensky teaches that vaccines can be improved and personalized by making the peptides/antigens patient specific by selecting peptides based on the patient’s immune status, previous treatment regimens, and HLA-haplotype (¶00386).
Regarding claim 31, Yelensky teaches the ChAdV vector comprises a ChAdV backbone which comprises an antigen cassette and a promoter and polyA sequence (¶0016). Yelensky further teaches that the antigen cassette is operably linked to the promoter (¶0016) and polyA sequence (¶0037).
Regarding claim 44, Yelensky teaches that the ChAdV backbone is a ChAdV68 backbone (¶0016).
Regarding claim 58, Yelensky teaches that the antigen-encoding nucleic acid sequence is an MHC class I epitope (¶0016).
Regarding claim 62, Yelensky teaches at least 10 distinct MHC class I antigen-encoding nucleic acid sequences linearly linked together (¶0016).
Regarding claim 69, Yelensky teaches that a neoantigen is an antigen that has an alteration that distinguished the antigen from wildtype (¶00156) and that the neo-antigen can have can have alterations that increase binding affinity, binding stability of presentation likelihood to/on its corresponding MHC allele (¶0044).
Regarding claim 72, Yelensky teaches that the alternation is a frameshift or nonframeshift indel, missense or nonsense substitution, splice site alteration, genomic rearrangement or gene fusion (¶00156).
Regarding claim 76, Yelensky teaches where the at least one antigen-encoding nucleic acid sequence comprises at least 2-10 antigen-encoding nucleic acid sequences (claim 56).
Regarding claim 81, Yelensky teaches wherein each MHC class I antigen-encoding nucleic acid sequence encodes a polypeptide sequence between 8 and 35 amino acids in length (claim 62).
Regarding claim 122, Yelensky teaches that the composition is a pharmaceutical composition with a pharmaceutically acceptable carrier (¶0085).
Regarding claim 124, Yelensky teaches that the epitope-encoding nucleic acid sequences are derived from the tumor of the subject with cancer (¶0020).
Regarding claim 128, Yelensky teaches wherein the epitope-encoding sequences in Instant SEQ ID NO: 14,915 (¶0016, see alignment below).
PNG
media_image1.png
1134
652
media_image1.png
Greyscale
Regarding claim 129, Yelensky teaches the antigen-encoding nucleic acid sequence comprises KRAS_G12C, KRAS_G12D, and/or KRAS_G12V MHC class I epitope-encoding nucleic acid sequence (¶0014).
Regarding claim 131, Yelensky teaches administering both a ChAdV68 vaccine and samRNA (¶00566), self-amplifying alphavirus (¶00327).
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