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 .
Election/Restrictions
Applicant's response to the Restriction Requirement, dated December 22, 2025, has been received. By way of this response, Applicant has elected Group I, claims 1-13, and a combination of six antigens comprising MUC1, HER2, hTERT, survivin, MAGEA3 and mammaglobin A.
Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 14 and 19-23 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 December 22, 2025.
Claims 1-13 are currently under examination before the Office.
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 1-4 and 11-12 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Meruelo (US20180000912A1). 1-4 and 11-12
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).
Meruelo further teaches compositions comprising the above and a pharmaceutically acceptable carrier, excipient, or diluent (para. 0128).
Meruelo further teaches that the above antigens may be linked with a cleavable spacer sequence (para. 0089), which is pertinent to claim 11.
Meruelo further teaches that the vector may be a DNA vector (para. 0007 and 0059), which is pertinent to claim 12.
Meruelo further teaches the use of Modified Vaccinia Ankara virus to induce an immune response form the above one or more antigens (para. 0148), which is pertinent to claim 13.
Meruelo also teaches that the above vector is useful to treat breast cancer (para. 0017 and claim 20).
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 1-13 are rejected under 35 U.S.C. 103 as being unpatentable over Meruelo (US20180000912A1) in view of Binder (US20190016775A1).
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).
Meruelo further teaches compositions comprising the above and a pharmaceutically acceptable carrier, excipient, or diluent (para. 0128).
Meruelo further teaches that the above antigens may be linked with a cleavable spacer sequence (para. 0089), which is pertinent to claim 11.
Meruelo further teaches that the vector may be a DNA vector (para. 0007 and 0059), which is pertinent to claim 12.
Meruelo further teaches the use of Modified Vaccinia Ankara virus to induce an immune response form the above one or more antigens (para. 0148), which is pertinent to claim 13.
Meruelo also teaches that the above vector is useful to treat breast cancer (para. 0017 and claim 20).
However, Meruelo does not teach the use of a full-length protein encoded by the MUC1 gene.
Binder teaches a plasmid encoding full-length MUC1 antigen (para. 0637). Binder teaches that this plasmid is useful as in treating breast cancer (para. 0019).
Binder also teaches an immunogenic human TERT (hTERT) protein, either the full length or a truncated form (para. 0247).
Binder also teaches vectors which co-express multiple tumor-associated antigens (para. 0195-0197).
It would have been prima facie obvious for a person of ordinary skill in the art as of the effective filing date to combine the teachings of the Meruelo and Binder to arrive at the claimed invention. An ordinary artisan would have been motivated to do so, and have a reasonable expectation of success, since Meruelo and Binder are both concerned with vectors comprising tumor-associated antigens for treatment of breast cancer. As stated above, compositions comprising vectors encoding MUC1, HER2, hTERT, survivin, MAGE-A3, and mammaglobin-A were taught by Meruelo. Binder also teaches vectors which co-express multiple tumor-associated antigens, as well as teachings that the full length of the protein may be used in such a system. Using the full length of each antigen, according to the teachings of Binder, in the vector of Meruelo, would result in epitopes that encompass the sequences recited by claims 5-10. Each component of the combination would perform its known, usual function, and the combination would have yielded nothing more than predictable results.
All the claimed elements were known in the prior art and one of ordinary skill in the art could have arrived at the claimed invention by using known methods with no change in their respective functions, and the combination would have yielded nothing more than predictable results.
Therefore, the invention, as a whole, was prima facie obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention as evidenced by the references, especially in the absence of evidence to the contrary.
Conclusion
No claim is allowed.
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/PETER JOHANSEN/Examiner, Art Unit 1644