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.
Claims Status
As per preliminary claim amendment received on 10/16/2024, claims 1-19 are pending, and claims 3-8, 12, 14-15 and 17-19 have been amended.
Drawings
The drawings are objected to because Figs. 1, 2, 5, 7 and 8 are blurry and contain areas that are not legible. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objection
Claims 11 and 15 are objected to because of the following informalities:
Claim 11, has claim clauses of c) and d), but there isn’t clause a) or b).
Claim 15 line 5 has the following typographical error “…NU7026 orNU 7441 .or a…”
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 4-7 and 17-18 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Each of claims 4-7 discloses only limitations pertaining to intended results of the two treatment steps recited in claim 1, such as: “wherein the one or more cancel cells at the target site have double stranded DNA breaks” (recited in claim 4). These claims fail to further limit independent claim 1 because they do not include additional (treatments) steps, refine the treatment parameters of previously recited (treatment) steps, or specify a device/drug for performing the previously recited (treatment) steps. Merely reciting an intended result does not further limit.
Similarly, claims 17 and 18, these claims fail to further limit independent claim 9 for the same reason discussed immediately above.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
For purposes of examination, claims 4-7 and 17-18 are treated as functional limitations of respective independent claims, and thus, these claims are rejected when a reference teaches the treatment steps in said respective independent claims. The Examiner suggests amending these claims to include specific treatment parameters or additional treatment steps directly involved in the currently recited functional limitations.
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 17-19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Peyman US 11,660,229 B2.
Regarding claim 1, Peyman discloses a method of treating a subject having cancer (see abstract: combination of thermotherapy, immunotherapy, and gene therapy for tumor treatment) comprising:
a) applying an alternating electric field to a target site of the subject for a period of time (col.13, ll.5-9 treating tumor site using alternating electric field, see col.16, ll.40-49 for treatment duration), wherein the target site comprises one or more cancer cells (col.13, ll.4-13 using MRI or ultrasound imaging to verify tumor for said treatment. Also see col.83, ll.1-10 and also Fig.1: tumors 32, 42, 44 on person 10), 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, also see col.113, ll.23-49 discusses enhancing effect of immunotherapy or medication) of a DNA-dependent protein kinase (PK) inhibitor to the subject. (col.83, ll.40-41 discloses using vemurafenib, col.113, ll.28 discloses using LY294002, both vemurafenib and LY294002 are different types of DNA-dependent PK inhibitor according to the Applicant’s own Specification [0082])
Regarding claim 2, Peyman 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. (See col.82, ll.83, ll.17-20 ovarian cancer and prostate cancer, brain tumors; also see col.113, ll.38-44 using the discussed combined inhibitors and thermotherapy for treatments of pancreatic cancer, breast cancer and brain cancer, including glioblastoma, glioma, prostate cancer, ovarian cancer.)
Regarding claim 3, Peyman discloses the method of claim 1, wherein the subject having cancer has undergone or is currently undergoing radiation therapy or chemotherapy. (See col.22, ll.65-col.23, ll.4 radiation therapy, col.108, ll.15-29 simultaneous radiation, chemical and thermal treatments)
Regarding claims 4-7, these claims are rejected by Peyman under the broadest reasonable interpretation for functional limitations as discussed under 35 USC 112(d) rejection above.
Regarding claim 8, Peyman discloses the method of claim1, wherein the therapeutically effective amount of a DNA-dependent protein kinase (PK) inhibitor is administered orally, subcutaneously or intravenously. (Peyman discusses that inhibitors are administered orally, subcutaneously or intravenously depending on the type of inhibitors used, see col.3, ll.59-col.4, ll.33)
Regarding claim 9, it is rejected by Peyman under the same rationale as discussed to claim 1 above. In here, the claim term “exposing” is interpreted by the Examiner as analogous to “applying” in claim 1.
Regarding claim 10, it is rejected by Peyman under the same rationale as discussed to claim 3 above.
Regarding claim 11, it is rejected by Peyman under the same rationale as discussed to claim 1 above. In here, the claim term “exposing” is interpreted by the Examiner as analogous to “applying” in claim 1.
Regarding claim 12, Peyman discloses the method of claim 9, wherein the cancer cell is in a subject. (See col.5, ll.34-60 and Fig.1: tumors 32, 42, 44 on person 10)
Regarding claim 13, Peyman 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 col.5, ll.34-60 and Fig.1: tumors 32, 42, 44 on person 10)
Regarding claim 14, it is rejected by Peyman under the same rationale as discussed to claim 2 above.
Regarding claim 15, Peyman 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. (See col.83, ll.40-41 discloses using vemurafenib, col.113, ll.28 discloses using LY294002)
Regarding claims 17 and 18, these claims are rejected by Peyman under the broadest reasonable interpretation for functional limitations as discussed under 35 USC 112(d) rejection above.
Regarding claim 19, Peyman 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. (col.100, ll.20-21 100-300 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 Peyman as applied to claim 11 and in view of Majd et al. “The promise of DNA damage response inhibitors for the treatment of glioblastoma” (full citation below).
Regarding claim 16, Peyman discloses the method of claim 15, 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 advance 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 Peyman to further include using VX- 984 for combined thermotherapy, immunotherapy, and gene therapy for tumor treatment. (Peyman: abstract, and Majd: page 1) Neither Peyman, 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
Full citation for applied reference:
Nazanin K Majd, Timothy A Yap, Dimpy Koul, Veerakumar Balasubramaniyan, Xiaolong Li, Sabbir Khan, Katilin S Gandy, W K Alfred Yung, John F de Groot, The promise of DNA damage response inhibitors for the treatment of glioblastoma, Neuro-Oncology Advances, Volume 3, Issue 1, January-December 2021, vdab015, <https://doi.org/10.1093/noajnl/vdab015> accessed on 03/19/2026
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure in at least a 35 USC 102 rejection to the independent claims:
Desai et al. US 2021/0000752 [0055, 0086, 0261, 0308, 0310] discloses treatment fir glioblastoma and epilepsy using wave-like electric fields called tumor treating fields, e.g., Optune® treatment and CC-115
Voloshin-sela et al. US 2022/0096818 A1 see abstract and [0049], cancer treatment including alternating electric field and CC -115, SF2523
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
March 19, 2026
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