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 .
Claim Status
Applicant’s election without traverse of claims 19 – 21 in the reply filed on June 1, 2026, is acknowledged.
Claims 1 – 18 and 22 – 31 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 June 1, 2026.
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 19 – 21 are rejected under 35 U.S.C. 103 as being unpatentable over Yu et al. (U.S. Patent Application Publication No. 20170173130; cited on IDS, hereinafter Yu) in view of Lee et al. (Type 1-polarized dendritic cells loaded with autologous tumor are a potent immunogen against chronic lymphocytic leukemia, Type 1-polarized dendritic cells loaded with autologous tumor are a potent immunogen against chronic lymphocytic leukemia. J Leukoc Biol. 2008 Jul;84(1):319-25; hereinafter Lee).
Regarding claims 19 – 21, Yu discloses isolating a population of dendritic cells (DC) (para. [0075]) having loaded thereon a peptide that has 100% identity to SEQ ID NO: 1 of the instant application (para. [0020], SEQ ID NO: 7, KIFGSLAFL). Yu does not explicitly disclose that the dendritic cells are “alpha”.
However, Lee discloses the motivation for using a type 1 alpha (α) DC, which was engineered to cross-present (Abstract) the antigens expressed by chronic lymphocytic leukemia (CLL) cells, is to induce antigen-specific, functional cytotoxic T lymphocyte (CTL) responses. Lee further discloses that the DCs are engineered to be “nonexhausted” (p. 322, Elevated, rather than “exhausted,”…) after maturation. Regarding claim 21, Yu discloses pharmaceutical compositions in various embodiments (para. [0094] – [0097]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have combined the HER2 peptide of Yu with the ex vivo-generated α-DCs of Lee in order to treat HER2+ breast cancer. Doing so would improve the efficacy of the treatment, as nonexhausted α-DCs are potent inducers of antigen-specific T cells, according to Lee.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WALTER JACKSON III whose telephone number is (571)272-0247. The examiner can normally be reached M-F 9:00A - 5:00P.
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/WALTER JACKSON III/Examiner, Art Unit 1638
/Tracy Vivlemore/Supervisory Primary Examiner, Art Unit 1638
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