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 .
1. Claims 6-20 are new.
Claims 1-20 are pending and under examination.
Claim Objections
2. Claim 1 is objected to because of the recitation “at least one or more” in line 5. Correction to “one or more” is required.
3. Claim 1 should recite “in a subject in need thereof” in line 2.
4. Claim 3 is objected to because of the recitation “a surgery, a chemotherapy”. Correction to “surgery, chemotherapy” is required.
5. Claim 4 is objected to because of the recitations: “CTLA-4 antibody”; “TCR-T therapy”; “CAR-T therapy”; “a CD38 antibody”; a CD33 antibody”; a CD37 antibody”; “a CD25 antibody”; a VEGF antibody”; “a CD70 antibody”; a CD27 antibody”; a BCMA antibody”; and “a GPRC5D antibody”.
Appropriate correction to: “an anti-CTLA-4 antibody”; “a TCR T-cell”; “a CAR T cell”; “an anti-CD38 antibody”; an anti-CD33 antibody”; an anti-CD37 antibody”; “an anti-CD25 antibody”; an anti-VEGF antibody”; “an anti-CD70 antibody”; an anti-CD27 antibody”; an anti-BCMA antibody”; and “an anti-GPRC5D antibody” is required.
6. Claim 20 is objected to because of the recitation “pelvis”. Correction to “the pelvis” is required.
Claim Rejections - 35 USC § 103
7. 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.
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.
8. Claims 1-9 and 11-20 are rejected under 35 U.S.C. 103 as being unpatentable over Lloyd et al. (WO 02/092836), in view of both Ying et al. (Nature Medicine, 1999, 5: 823-827; cited on the IDS field on 07/15/2024) and Ott et al. (Eur. Soc. Med. Oncol., 2018, Abstract).
Lloyd et al. teach that CA125 protein is overexpressed in ovarian cancer. Lloyd et al. teach a polynucleotide encoding a CA125 fragment and using the polynucleotide as a vaccine to treat ovarian cancer in a subject in need of treatment; the polynucleotide is either a DNA or an mRNA; the sequences of the polynucleotide and encoded CA125 fragment are shown in Fig. 7 and Fig. 8, respectively (claims 1, 9, and 19) (see p. 1; p. 3, lines 1-15; p. 7; p. 10, lines 4-17; claim 4, 9, and 13). As evidenced by the attached Sequence Alignments, the CA125 fragment in Fig. 8 comprises the polypeptide set forth by the claimed SEQ ID NO: 337 (claim 1); the polynucleotide in Fig. 7 comprises the claimed SEQ ID NO: 338, which encodes SEQ ID NO: 337 (claim 9). With respect to claims 6-8, the recitation that the polynucleotide encodes two or more peptide sequences is reasonably interpreted as not specifically requiring that the additional polypeptides be selected from the sequences recited in the parent claim 1. Thus, the polynucleotide taught by Lloyd et al. reads on the claims because it encodes fragments other than the one set forth by the claimed SEQ ID NO: 337, which are contiguous with the fragment set forth by the claimed SEQ ID NO: 337.
Lloyd et al. do not specifically teach that a self-replicating RNA (claim 1). Ying et al. teach that using self-replicating RNA enhances the immunogenicity of nucleic acid vaccines (see Abstract; p. 825, column 2, last paragraph). Using a self-replicating RNA for the delivery of the polynucleotide encoding the CA125 fragment would have been obvious to one of skill in the art, with the reasonable expectation that doing so would result in enhanced therapy.
With respect to claims 11 and 12, Lloyd et al. teach that CA125 is overexpressed in epithelial ovarian cancer (see p. 1, lines 23-26). Thus, one of skill in the art would have found obvious to administer the polynucleotide to subjects affected by epithelial ovarian cancer, to achieve the predictable result of treating the cancer in these subjects. With respect to claims 13-18 and 20, one of skill in the art would have reasonably concluded that the self-replicating RNA could be used to treat any of the various subjects recited in the claims. Administering the self-replicating RNA in these various subjects would have been obvious to one of skill in the art, to achieve the predictable result of treating them for ovarian cancer.
Lloyd et al. and Ying et al. do not teach nivolumab (claims 2-4). Ott et al. teach that the combination of neoantigen vaccine and nivolumab (an anti-PD-1 antibody; claim 5) is synergistic. Ott also teach administering the vaccine in a prime-boost format (claim 1) (see Abstract). One of skill in the art would have found obvious to modify the method of Lloyd et al. and Ying et al. by using a prime-boost format and by also administering nivolumab, with the reasonable expectation that doing so would result in enhanced therapeutic effect.
Thus, the claimed invention was prima facie obvious at the time of its effective filing date.
9. Claims 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over Lloyd et al. taken with both Ying et al. and Ott et al., in further view of Okada et al. (J. Clin. Oncol., 2011, 3: 330-336).
The teachings of Lloyd et al., Ying et al., and Ott et al. are applied as above for claims 1-9 and 11-20. Lloyd et al., Ying et al., and Ott et al. do not specifically teach a second booster (claim 10). Okada et al. et al. teach that repeated boosters result in successful cancer therapy (see p. 334, column 1, fourth paragraph). Based on these teachings, one of skill in the art would have found obvious to use repeated boosters, with the reasonable expectation that doing so would successfully treat the ovarian cancer in the subject.
Thus, the claimed invention was prima facie obvious at the time of its effective filing date.
10. No claim is allowed. No claim is free of prior art.
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/ILEANA POPA/ Primary Examiner, Art Unit 1633
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