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 .
Applicant's response to the previous Office action, dated May 11, 2026, has been received. By way of this submission, Applicant has amended claim 1, and cancelled claims 2-4.
Claims 1, 5-14, and 19-23 are pending in the application. Claims 14 and 19-23 remain withdrawn from consideration, pursuant to the Restriction Requirement mailed September 23, 2025.
Claims 1 and 5-13 are therefore under examination before the Office.
The rejections of record can be found in the previous Office action, dated February 10, 2026.
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1 and 11-12 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Meruelo (US20180000912A1).
Applicant argues that Meruelo does not teach every aspect of the claims as amended; specifically, Meruelo does not teach the specific combination of at least six antigens encoded by a gene selected from the group consisting of MUC1, HER2, hTERT, Survivin, MAGEA3 and Mammaglobin A.
Applicant's arguments have been considered fully but are not found to be persuasive.
Meruelo teaches a viral vector, which comprises a nucleic acid that encodes one or more tumor associated antigens (para. 0006). Meruelo further teaches that the antigens may be MUC1, HER2, hTERT, survivin, MAGE-A3, and mammaglobin-A (para. 0008, 0125 and claim 4). The language of "one or more" of Meruelo encompasses a vector comprising six antigens.
Claim 1 also states that the vector encodes at least one epitope from "at least six antigens". A vector containing more than the recited six would therefore still be within the scope of the claims. Furthermore, the transitional term "comprising" is inclusive or open-ended and does not exclude additional, unrecited elements. MPEP 2111.03(I).
This rejection is therefore maintained.
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.
Claims 1 and 5-13 are rejected under 35 U.S.C. 103 as being unpatentable over Meruelo (US20180000912A1) in view of Binder (US20190016775A1).
Applicant argues that Meruelo only discloses specific combinations of at most three tumor-associated antigens, and a person of ordinary skill would not have selected the specific combination of six antigens recited in amended claim 1. Applicant further argues that each combination of antigens disclosed in Meruelo differs from the claimed combination by at least five additional antigens, and given the large number of antigens disclosed in Meruelo, one of ordinary skill would not have been motivated to select the six antigens recited in claim 1.
Applicant's arguments have been considered fully but are not found to be persuasive.
As stated above, Meruelo teaches a viral vector, which comprises a nucleic acid that encodes one or more tumor associated antigens (para. 0006). Meruelo further teaches that the antigens may be MUC1, HER2, hTERT, survivin, MAGE-A3, and mammaglobin-A (para. 0008, 0125 and claim 4). The language of "one or more" of Meruelo encompasses a vector comprising six antigens.
Claim 1 also states that the vector encodes at least one epitope from "at least six antigens". A vector containing more than the recited six would therefore still be within the scope of the claims. Furthermore, the transitional term "comprising" is inclusive or open-ended and does not exclude additional, unrecited elements. MPEP 2111.03(I).
The examples recited by Meruelo are not intended to be limiting to the disclosure (para. 0155 of Meruelo).
The antigens recited in claim 1 as amended were all known to be tumor-associated antigens, and the teachings of Meruelo make it clear that such combinations were known to be useful as a method of treating cancer (see, e.g., para. 0017). Additionally, Meruelo teaches that the skilled practitioner is also to select suitable tumor-associated antigens for use in the polynucleotide (para. 0093).
This rejection is therefore maintained.
Conclusion
No claim is allowed.
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 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 PETER JOHANSEN whose telephone number is (571)272-0280. The examiner can normally be reached Monday-Friday, 7:00 to 3:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Samira Jean-Louis can be reached at (571) 270-3503. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PETER JOHANSEN/Examiner, Art Unit 1644
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