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 .
Response to Amendment
In the amendment filed on 08/18/2026 Applicant amended claims 1 and 2, cancelled claims 4, 10 and 11. Claims 1-3, 5-9, 12-16, 19-22 and 27 are pending; claims 3 and 27 remain withdrawn for reason of record. Claims 1-2, 5-9, 12-16 and 19-22 are examined.
Drawings
The replacement sheets comprising the Figures 1A-4C were received and considered by the Office.
Withdrawn claim rejections
Double Patenting
The rejections of claims 1, 2 and 9 on the ground of nonstatutory double patenting as being unpatentable over claims of U.S. Patent No. 11, 998,594 in view of Patel et al., is withdrawn in view of the amendments to the claims.
The rejections of claims 1, 2 and 22 on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, 6 and 10 of U.S. Patent No. 11,260,121 in view of Patel et al., is withdrawn in view of the amendments to the claims.
The rejections of claims 1-2, 9 and 22 on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of U.S. Patent No. 11,433,123 in view of Patel et al., is withdrawn in view of the amendments to the claims.
The rejections of claims 1-2, 4, 13 and 22 on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 and 16-17 of U.S. Patent No. 11,617,787 in view of Patel et al., is withdrawn in view of the amendments to the claims.
Maintained claim rejections
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.
Claims 1-2, 5-9, 12-16, 19 and 21-22 remain rejected under 35 U.S.C. 103 as being unpatentable over Steinmetz et al. (WO2018208828) in view of Yeung et al. (U.S. Pub. No. 20180318365) and Patel et al. (Radiation therapy combined with cowpea mosaic virus nanoparticle in situ vaccination initiates immune-mediated tumor regression, ACS Omega, 3, 3702−3707, 2018) for reasons of record.
On page 1-3 of the Remarks Applicant argues that: “Steinmetz, alone or in combination with Yeung and Patel fails to teach or suggest Applicant's claimed methods including administering to the subject a CPMV particle and a cancer cell including an antigen or an antigen therefrom where the cancer cell was irradiated prior to administration.”
The arguments were carefully considered but not found persuasive because the Yeung et al., reference clearly indicates that the irradiated cancer cells were used in the treatments of the reference ([0027] In some embodiments according to any one of the methods provided above, the method further comprises locally administering to the site of the tumor an effective amount of inactivated tumor cells. In some embodiments, the inactivated tumor cells are autologous. In some embodiments, the inactivated tumor cells are allogenic. In some embodiments, the inactivated tumor cells are from a tumor cell line. In some embodiments, the inactivated tumor cells are inactivated by irradiation.).
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Steinmetz et al. in view of Patel et al. and Yeung et al. (U.S. Pub. No. 20180318365) (all cited supra) and in further view of Hodge et al. (The tipping point for combination therapy: cancer vaccines with radiation, chemotherapy, or targeted small molecule inhibitors. Sem. Oncol. 39, 323-339, 2012).
The claim adds the limitation that the method of independent claim 1 is performed when the cancer is clinically undetectable.
The teachings of Steinmetz et al., Patel et al. and Yeung et al. were presented supra and they were silent about using the methods in conditions that the cancer was clinically undetectable.
Hodge et al. examines the preclinical and clinical interactions between vaccine mediated tumor-specific immune responses and local radiation, systemic chemotherapy, or select small molecule inhibitors, as well as the potential synergy between these modalities. The reference underscores that local control of the primary tumor is necessary and can usually prevent metastasis, but radiation alone generally fails to control preexisting systemic disease, which may be present as undetectable micro metastases.
Immunomodulators (cancer vaccines) in concert with the radiation-induced cell death wherein dying tumor cells release tumor-associated antigens (TAAs) that can potentially be exploited to stimulate robust tumor-specific immune responses (Abstract, Figure 1).
It would have been obvious for a person of ordinary skill in the art at the time that
the invention was filed to combine the teachings of Steinmetz et al., Patel et al. and Yeung et al. and treat or inhibit clinically undetectable cancer growth with a reasonable expectation of success. This is because Hodge et al. indicated the superior results of combining cancer vaccines and tumor antigens resulted from radiation of the tumor cells.
On page 6 of the Remarks Applicant argues that: “Hodge does not cure such deficiency. Rather, Hodge discloses the use of local radiation in radiation therapy, from which "dying tumor cells release tumor-associated antigens (TAAs) that can potentially be exploited to stimulate robust tumor-specific immune responses." Hodge at p. 324. In Hodge's system, antigens from irradiated cancer cells are not administered, but instead, released by in vivo tumor cells at the tumor site in response to radiation-induced cell death.”
The arguments were carefully considered but not found persuasive because the teachings of Hodge et al. are read in the context of Steinmetz et al., Patel et al. and Yeung et al. As indicated supra the Yeung et al., reference clearly indicates that the irradiated cancer cells were used in the treatments of the reference.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
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ELLY-GERALD STOICA
Primary Examiner
Art Unit 1647
/Elly-Gerald Stoica/ Primary Examiner, Art Unit 1647
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