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 .
The current application has the effective filing date of 06/30/2023 according to the priority chain on the record.
Claim Status
As per Applicant’s response received on 06/29/2026, claims 1-19 are pending, claim11 and 15 have been amended.
Response to Amendment
The claim objection is withdrawn in view of current claim amendment.
The drawing objection is withdrawn in view of replacement drawings.
As for the 35 USC 112(d) rejection to claims 4-7 and 17-18, the applicant’s arguments have been fully considered. As reasoned by the Applicant, the recitation in these claims refer to “a property that could occur and therefore narrows claims 1 because claim 1 can still encompass cells that do not have double stranded DNA breaks”, these further affirms the Examiner’s interpretation that these are intended results of the recited method steps of respective independent claims. In view of this, the rejections are withdrawn, but each of claims 4-7 and 17-18 are interpreted as intended results. See MPEP 2111.04 “the court noted that a “‘whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.’” Id. (quoting Minton v. Nat’l Ass’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003)).”
As for the 35 USC 102(a)(1) rejection base on Peyman IS 11,660,229 B2, the Applicant’s arguments have been fully considered but are moot in view of new grounds of rejections made below.
Claim Objections
Claim 15 is objected to because of the following informalities: “CC-115” is repeated. Appropriate correction is required.
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.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-15 and 18-19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Voloshin-Sela et al. US 2022/0096818 A1 (hereinafter “Vol”, cited in previous PTO 892).
Regarding claim 1, Vol discloses a method of treating a subject having cancer (see abstract) comprising:
a) applying an alternating electric field to a target site of the subject for a period of time, wherein the target site comprises one or more cancer cells ([0049] exposing/administering alternative electric field to cancer cells; [0130-0131] discusses different treatment intervals ranging from 0.5 hours to 72 hours.), and
b) administering a therapeutically effective amount (this limitation is implicitly taught by the reference as the purpose of providing pharmaceuticals for cancer treatment is to achieve therapeutic effect for individual patients) of a DNA-dependent protein kinase (PK) inhibitor to the subject. ([0049] exposing/administering inhibitors, e.g. CC-115, SF2523, and NU7441; these inhibitors qualify as “DNA-dependent protein kinase (PK) inhibitor” according to the Applicant’s own Specification [0052, 0073])
Regarding claim 2, Vol discloses the method of claim 1, wherein the cancer is ovarian cancer, hepatobiliary cancer, prostate cancer, pancreatic cancer, head and neck cancers, glioblastoma, gliosarcoma, leukemia, or non-small cell lung cancer. ([0040: last sentence] glioblastoma, ovarian, or lung metastatic carcinoma)
Regarding claim 3, Vol discloses the method of claim 1, wherein the subject having cancer has undergone or is currently undergoing radiation therapy or chemotherapy. (See [0060] “In some aspects, the methods can further comprise exposing a cell to radiation therapy.” and [0077: last sentence] the disclosed alternating electric field treatment can be combined with radiation therapy. Also see [0003, 0060, 0079, 0085, 0122] the disclosed alternating electric field treatment can be combined with chemotherapy or a chemotherapeutic agent)
Regarding claims 4-7, these claims are rejected by Vol under the broadest reasonable interpretation for functional limitation/intended results of applying the method steps as recited in claim 1, see discussion under Response to Arguments and MPEP 2111.04.
Regarding claim 8, Vol discloses the method of claim 1, wherein the therapeutically effective amount of a DNA-dependent protein kinase (PK) inhibitor is administered orally, subcutaneously or intravenously. (See [0042] administering vi means by oral, subcutaneously, or intravenously)
Regarding claim 9, this claim is rejected by Vol under the same rationale as discussed to claim 1 above. In here, the claim term “exposing” is interpreted by the Examiner as analogous and broader than “applying” and “administering” in claim 1. Vol also discusses “exposing” in [0006].
Claim 10 is rejected by Vol under the same rationale as discussed to claim 3 above.
Regarding claim 11, this claim is rejected by Vol under the same rationale as discussed to claim 1 above. In here, the claim term “exposing” is interpreted by the Examiner as analogous and broader than “applying” and “administering” in claim 1. Vol also discusses “exposing” in [0006].
Regarding claim 12, Vol discloses the method of claim 9, wherein the cancer cell is in a subject. (see Brief Summary, i.e. [0007-0008] which discusses treating a subject having cancer)
Regarding claim 13, Vol discloses the method of claim 12, wherein exposing the cancer cell to an alternating electric field comprises administering the alternating electric field to a target site of the subject, wherein the target site comprises one or more cancer cells. (See rejection to claim 11; Vol: [0049] exposing/administering alternative electric field to cancer cells)
Claim 14 is rejected by Vol under the same rationale as discussed to claim 2 above.
Regarding claim 15, Vol discloses the method of claim 9, wherein the DNA-dependent PK inhibitor is Nedisertib, VX-984, CC-115, CC-122, AZD7648, matinib, vemurafenib, gefitinib, Peposertib (M3814), MSC2490484A, LY294002, JU-57788, CC-115, BAY-8400, SF2523, LTURM34,Compound 401, AMA-37, IC 86621, DNA-PK-IN-1/2/3/4/5/6/7/8/9 , NU7026, NU7441, or a combination thereof. ([0049] CC-115, SF2523, and NU7441)
Regarding claims 17 and 18, these claims are rejected by Vol under the broadest reasonable interpretation for functional limitation/intended results of applying the method steps as recited in claim 1, see discussion under Response to Arguments and MPEP 2111.04.
Regarding claim 19, Vol discloses the method of claim 1, wherein the alternating electric field has a frequency and field strength, wherein the frequency is between 100 kHz and 1 MHz. ([0128] “The frequency of the alternating electric fields can also be, but is not limited to, between 50 and 500 kHz…”)
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.
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Vol as applied to claim 9 above, and further in view of Majd et al. “The promise of DNA damage response inhibitors for the treatment of glioblastoma” (hereinafter “Majd”, previously cited).
Regarding claim 16, Vol discloses the method of claim 15 including administering plurality of different inhibitors ([0049-0054]), but does not disclose wherein DNA-dependent PK inhibitor is VX- 984 and wherein the therapeutically effective amount of VX- 984 is 50-720 mg/day.
Majd, a prior art reference in the field of glioblastoma (GBM) treatment, discloses recent research focuses on using DNA-dependent protein kinases as a fourth modality for treating GBM in addition to maximal safe resection, radiotherapy (RT), and chemotherapy with the alkylating agent temozolomide (TMZ) (abstract and pg. 1: bottom). Majd notes that DNA-PK inhibitors are the most clinically advanced inhibitors of NHEJ proteins (Non-Homologous End Joining protein, responsible for repairing double strand breaks in DNA). Majd, in pg. 2-4 section titled “DNA-PK Inhibitors” discusses various types of inhibitors in clinical development including using VX-984 in combination with chemotherapy in patients with advanced solid cancers. Accordingly, it would have been obvious to a person of ordinary skill in the art at the time of invention to modify Vol to further include using VX- 984 for combined thermotherapy, immunotherapy, and gene therapy for tumor treatment. (Vol: abstract, and Majd: page 1) Neither Vol, nor Majd explicitly disclose that the therapeutically effective amount of VX- 984 is 50-720 mg/day. However, Majd discloses conducting various phases of clinical trials to test different combinations of pharmaceuticals, timing and modifying dosing amount (Majd, pgs.5-8 “Strategies for Successful Clinical Development of DDR Inhibitors for GBM Patient”). As such, it would have been routine optimization (MPEP 2144.05 II) during clinical trials, as discussed in Majd, to determine that therapeutically effective amount of VX- 984 is 50-720 mg/day.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHIRLEY X JIAN whose telephone number is (571)270-7374. The examiner can normally be reached M-F 8:00-4:00.
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/SHIRLEY X JIAN/ Primary Examiner, Art Unit 3792
September 21, 2026
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