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 .
Preliminary Amendment
Preliminary Amendment dated 04/07/2023 has been formally entered and claims 1-16, 21-24 submitted with Preliminary Amendment dated 04/07/2023 are being examined on the merits.
Claim Objections
Following claims are objected to because of the following informalities:
Claim 1 lines 3-4 the limitation “the caner of the patient” needs to be corrected to -- the [[caner]] cancer of the patient--.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 16 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement for the following reasons:
Please note that, USPTO personnel are to give claims their broadest reasonable interpretation in light of the supporting disclosure. In re Morris, 127 F.3d 1048, 1054-55, 44 USPQ2d 1023, 1027-28 (Fed. Cir. 1997). Limitations appearing in the specification but not recited in the claim should not be read into the claim. E-Pass Techs., Inc. v. 3Com Corp., 343 F.3d 1364, 1369, 67 USPQ2d 1947, 1950 (Fed. Cir. 2003) (claims must be interpreted "in view of the specification" without importing limitations from the specification into the claims unnecessarily). In re Prater, 415 F.2d 1393, 1404-05, 162 USPQ 541, 550-551 (CCPA 1969). See also In re Zletz, 893 F.2d 319, 321-22, 13 USPQ2d 1320, 1322 (Fed. Cir. 1989) ("During patent examination the pending claims must be interpreted as broadly as their terms reasonably allow.... The reason is simply that during patent prosecution when claims can be amended, ambiguities should be recognized, scope and breadth of language explored, and clarification imposed.... An essential purpose of patent examination is to fashion claims that are precise, clear, correct, and unambiguous. Only in this way can uncertainties of claim scope be removed, as much as possible, during the administrative process.").
Consequently, a broad yet reasonable interpretation of claim 16 lines 2-3 limitation “a cell-based cancer therapy composition specific for an extracellular target or an intracellular target of a cancer cell of a patient suffering from cancer” would encompass the limitation “a cell-based cancer therapy composition specific for an intracellular target of a cancer cell of a patient suffering from cancer”. Under this interpretation claim 16 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement as claim 16 under this broad yet reasonable interpretation contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. More specifically, specification as-filed (for example see at least fig. 2, [0094-0096]. Specifically see [0094] “Because the target … is not presented on the surface of cancer cells, the cell-based target-specific cancer therapies of the first method 100 would not be effective against it. Instead, small molecule cancer therapies that are specific for the intracellular target and capable of entering cancer cells are administered (at 220) in the second method 200.”), does not disclose administering the cell-based target-specific cancer therapy to the patient, wherein a cell of the cell-based cancer therapy interacts with the target to have therapeutic effect on for an intracellular target of a cancer cell of a patient suffering from cancer. Examiner notes that specification as-filed does find support for a cell surface target protein as being the therapeutic target of the cell-based target-specific cancer therapy (sand an intracellular target protein being the therapeutic target of the small molecule cancer therapy.
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(B) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
Claims 1-16, 21-24 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which applicant regards as the invention.
Claims 16 line 7-8 recites the limitation " the cell-based target-specific cancer therapy ". There is insufficient antecedent basis for this limitation in the claim. Additionally, it is unclear as to whether claims 16 line 7-8 recites the limitation " the cell-based target-specific cancer therapy " is the same as, different than or in addition to “cell-based cancer therapy” in claim 16 line 2 and if different in what way the two differ.
Claim 16 in line 6 recites “a target” which renders this claim unclear. More specifically, it is unclear as to whether claim 16 line 6 “a target” is the same as, different than or in addition to “an extracellular target” or “an intracellular target” recited in claim 16 lines 2-3. If different in what way they differ. Additionally, it is unclear as to which of the “an extracellular target” or “an intracellular target” recited in claim 16 lines 2-3, claim 16 line 6 “a target” is referencing.
Claim 16 in line 9 recites “the target” which renders this claim unclear. More specifically, it is unclear as to claim 16 line 9 “the target” is referencing “an extracellular target” of claim 16 line 2 and/or “an intracellular target” recited in claim 16 lines 3.
Each of claim 1, claim 9 and claim 16 recite the term “low-dose radiation” which renders this claim unclear. The term “low-dose radiation” in the context used in each of these claims is a relative term which renders the claim indefinite. The term “low-dose radiation” is not explicitly or specifically defined by the claim and neither is the frame of reference in comparison to which radiation is determined to be “low-dose”, and consequently one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
Each of claims 21-24 recites ranges prefixed by the term “about” which render each of these claims unclear. More specifically, the term " about" here in each of the claims 21-24 is a relative range term which renders the claim indefinite. The term " about" is not defined by the claim with respect to the boundary i.e. unclear as to whether the term “about” refers herein to a value of +/-0.25% of the defined measure; or the term “about” refers herein to a value of +/-0.10% of the defined measure or some other value or percentage. Additionally, the specification does not provide a standard for ascertaining the requisite degree/range, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
Dependent claims 2-8, 10-15, 21-24 when analyzed as a whole are held to be patent ineligible under 35 U.S.C. 112(b) because the additional recited limitations fail to cure the 35 U.S.C. 112(b) issue in their respective base claims. Consequently, dependent claims 2-8, 10-15, 21-24 are also rejected under 35 U.S.C. 112(b) based on their direct/indirect dependency on their respective base claims.
Claim Interpretation
Claims terms where relevant are being interpreted in light of definitions enumerated in instant application specification as-filed [0031-0034], [0042], [0047], [0049], [0098-0099], [0113].
Please note that USPTO personnel are to give claims their broadest reasonable interpretation in light of the supporting disclosure. In re Morris, 127 F.3d 1048, 1054-55, 44 USPQ2d 1023, 1027-28 (Fed. Cir. 1997). Limitations appearing in the specification but not recited in the claim should not be read into the claim. E-Pass Techs., Inc. v. 3Com Corp., 343 F.3d 1364, 1369, 67 USPQ2d 1947, 1950 (Fed. Cir. 2003) (claims must be interpreted "in view of the specification" without importing limitations from the specification into the claims unnecessarily). In re Prater, 415 F.2d 1393, 1404-05, 162 USPQ 541, 550-551 (CCPA 1969). See also In re Zletz, 893 F.2d 319, 321-22, 13 USPQ2d 1320, 1322 (Fed. Cir. 1989) ("During patent examination the pending claims must be interpreted as broadly as their terms reasonably allow.... The reason is simply that during patent prosecution when claims can be amended, ambiguities should be recognized, scope and breadth of language explored, and clarification imposed.... An essential purpose of patent examination is to fashion claims that are precise, clear, correct, and unambiguous. Only in this way can uncertainties of claim scope be removed, as much as possible, during the administrative process.").
Claim Rejections - 35 USC § 102
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 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 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.
Claims 1-4, 6-8, 21-22 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Chinnasamy et al. (Pub: “Chinnasamy D, Tran E, Yu Z, Morgan RA, Restifo NP, Rosenberg SA. Simultaneous targeting of tumor antigens and the tumor vasculature using T lymphocyte transfer synergize to induce regression of established tumors in mice. Cancer Res. 2013 Jun 1;73(11):3371-80. doi: 10.1158/0008-5472.CAN-12-3913. Epub 2013 Apr 30. PMID: 23633494; PMCID: PMC3686092”, hereinafter referred to as “Chinnasamy”).
As per independent Claim 1, Chinnasamy discloses a method (Chinnasamy in at least pages 3371-3378 for example discloses relevant subject-matter. More specifically, Chinnasamy in at least abstract, page 3371 col. 2 para. [2], page 3378 col. 2 para.[3] discloses a method. See at least abstract “a synergy between two T cell therapies, one directed against the stromal tumor vasculature and the other directed against antigens expressed on the tumor cell… beneficial effects of combining anti-angiogenic with tumor-specific immunotherapeutic approaches for the treatment of patients with cancer”), comprising:
administering low-dose radiation to a patient suffering from a cancer (Chinnasamy in at least abstract and page 3372, col. 2, para [2] for example discloses administering low-dose radiation to a patient suffering from a cancer . See at least Chinnasamy abstract "data presented here emphasize the possible beneficial effects of combining antiangiogenic with tumor-specific immunotherapeutic approaches for the treatment of patients with cancer"; page 3372, col. 2, para [2] - "they were irradiated with 5 Gy of total body irradiation"), whereby expression of a target on a surface of a cancer cell of the caner of the patient increases after the low-dose radiotherapy (Chinnasamy in at least page 3372 col. 2 para. [2] for example discloses expression of a target on a surface of a cancer cell of the caner of the patient increases after the low-dose radiotherapy. See at least Chinnasamy page 3372 col. 2 para. [2] “Where indicated mice also received a single dose of 2 x107 plaque-forming units (PFU) of recombinant vaccinia viral vaccine (rVV) coding for the relevant antigen (hgp100 or mouse TRP-1 or TRP-2) recognized by transferred T cells at the time of cell transfer to systematically modulate the intensity of antigen restimulation in vivo”); and
administering a cell-based target-specific cancer therapy to the patient, wherein a cell of the cancer therapy interacts with the target (Chinnasamy in at least abstract, page 3378 for example discloses administering a cell-based target-specific cancer therapy to the patient, wherein a cell of the cancer therapy interacts with the target. see Chinnasamy at least abstract “Simultaneous transfer of genetically engineered syngeneic T cells expressing a chimeric antigen receptor targeting the Vascular Endothelial Growth Factor Receptor-2 (VEGFR-2; KDR) that is over expressed on tumor vasculature and T cells specific for the tumor antigens gp100 (PMEL), TRP-1 (TYRP1), or TRP-2 (DCT) synergistically eradicated established B16 melanoma tumors in mice and dramatically increased the tumor-free survival of mice compared to treatment with either cell type alone or T cells coexpressing these two targeting molecules ").
As per dependent Claim 2, Chinnasamy further discloses method wherein the cancer is characterized by a solid tumor (Chinnasamy in at least page 3378 col. 3 para. [3] for example discloses cancer is characterized by a solid tumor. See at least Chinnasamy page 3378 col. 3 para. [3] “strategy is particularly meaningful for the treatment of solid tumors with known antigenic signatures and may encourage the clinical application of combined immunotherapy and anti-angiogenic therapy in the future”).
As per dependent Claim 3, Chinnasamy further discloses method wherein the target is selected from the group consisting of SCARB2, SERINC1, IL6ST, IL6R, XPC, ITGAV, MR1, and DCT (Chinnasamy in at least abstract for example discloses wherein the target is selected from the group consisting of SCARB2, SERINC1, IL6ST, IL6R, XPC, ITGAV, MR1, and DCT. See at least Chinnasamy abstract “Simultaneous transfer of genetically engineered syngeneic T cells expressing a chimeric antigen receptor targeting the Vascular Endothelial Growth Factor Receptor-2 (VEGFR-2; KDR) that is over expressed on tumor vasculature and T cells specific for the tumor antigens gp100 (PMEL), TRP-1 (TYRP1), or TRP-2 (DCT) synergistically eradicated established B16 melanoma tumors in mice and dramatically increased the tumor-free survival of mice compared to treatment with either cell type alone or T cells coexpressing these two targeting molecules”).
As per dependent Claim 4, Chinnasamy further discloses method wherein the administering comprises delivering from one dose to five doses of the low-dose radiation (Chinnasamy in at least page 3372 col. 2 para. [2] “they were irradiated with 5 Gy of total-body irradiation (TBI)”).
As per dependent Claim 6, Chinnasamy further discloses method wherein the cell of the cell-based target-specific cancer therapy is selected from the group consisting of a chimeric antigen receptor (CAR) T cell, a CAR natural killer (NK) cell, a T cell receptor (TCR) engineered T cell, and two or more thereof (Chinnasamy in at least page 3372 col. 1 para. [4] for example discloses wherein the cell of the cell-based target-specific cancer therapy is selected from the group consisting of a chimeric antigen receptor (CAR) T cell, a CAR natural killer (NK) cell, a T cell receptor (TCR) engineered T cell. See at least Chinnasamy page 3372 col. 1 para. [4] “Transduction efficiency of Pmel TCR, TRP1 TCR, and TRP2 TCR in CD3+ T cells was determined by staining the cells with the fluorescein isothiocyanate (FITC) conjugated antibodies against Vβ13, Vβ14, and Vβ3”).
As per dependent Claim 7, Chinnasamy further discloses method further comprising: administering an additional cancer treatment modality other than the cell-based target-specific cancer therapy to the patient (Chinnasamy in at least page 3378, col. 2 para. [3] for example discloses administering an additional cancer treatment modality other than the cell-based target-specific cancer therapy to the patient. See at least Chinnasamy page 3378, col. 2 para. [3] “strategy is particularly meaningful for the treatment of solid tumors with known antigenic signatures and may encourage the clinical application of combined immunotherapy and anti-angiogenic therapy in the future.”).
As per dependent Claim 8, Chinnasamy further discloses method wherein the additional cancer treatment modality is selected from the group consisting of surgical resection, chemotherapy, immunotherapy, checkpoint inhibitor therapy, oncolytic virus therapy, thermal therapy, and two or more thereof (Chinnasamy in at least page 3378, col 2, para [3] for example discloses wherein the additional cancer treatment modality is selected from the group consisting of surgical resection, chemotherapy, immunotherapy, checkpoint inhibitor therapy, oncolytic virus therapy, thermal therapy. See at least Chinnasamy page 3378, col 2, para [3] “treatment of solid tumors with known antigenic signatures and may encourage the clinical application of combined immunotherapy and antiangiogenic therapy in the future").
As per dependent Claim 21, Chinnasamy further discloses method wherein each dose of the low-dose radiation administered to the patient is about 0.1 Gy to about 10 Gy (Chinnasamy in at least page 3372 col. 2 para. [2] for example discloses wherein each dose of the low-dose radiation administered to the patient is 5Gy of TBI which fall within the range of about 0.1 Gy to about 10 Gy as now explicitly, positively and specifically recited by the Applicants. Chinnasamy in at least page 3372 col. 2 para. [2] “they were irradiated with 5 Gy of total-body irradiation (TBI)”).
As per dependent Claim 22, Chinnasamy further discloses method wherein each dose of the low-dose radiation administered to the patient is about 0.5 Gy to about 2 Gy (Examiner notes that here, both the upper and lower boundaries/thresholds are unclear. Consequently, Chinnasamy’s disclosure in at least page 3372 col. 2 para. [2] reads on subject-matter as now explicitly, positively and specifically recited by the Applicants i.e. wherein each dose of the low-dose radiation administered to the patient is 5 Gy of total-body irradiation (TBI) which is about 0.5 Gy to about 2 Gy. See Chinnasamy in at least page 3372 col. 2 para. [2] “they were irradiated with 5 Gy of total-body irradiation (TBI)”).
Claims 9-12, 14-15, 23-24 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Nathanson et al. (Pub. No.: WO 2019067543 A1, hereinafter referred to as “Nathanson”) as evidenced by Katsura et al. (Pub “Katsura M, Cyou-Nakamine H, Zen Q, Zen Y, Nansai H, Amagasa S, Kanki Y, Inoue T, Kaneki K, Taguchi A, Kobayashi M, Kaji T, Kodama T, Miyagawa K, Wada Y, Akimitsu N, Sone H. Effects of Chronic Low-Dose Radiation on Human Neural Progenitor Cells. Sci Rep. 2016 Jan 22;6:20027. doi: 10.1038/srep20027. PMID: 26795421; PMCID: PMC4726121”, hereinafter referred to as “Katsura”).
As per independent Claim 9, Nathanson discloses a method (Nathanson in at least abstract, page 2, page 3 [2], page 37 [3], page 44 [3], page 45 [6], page 67 [6], page 68 [1] for example discloses relevant subject-matter. More specifically, Nathanson in at least abstract, page 2, page 3 [2] for example discloses a method. See at least Nathanson abstract “methods of treating Glioblastoma and other EGFR mediated cancers… methods of treating Glioblastoma and other EGFR mediated cancers that have been determined to have altered glucose metabolism in the presence of inhibitors”; page 3 [2] “methods of treating cancer comprising of administering to a subject in need of a treatment for cancer an effective amount of a compound of formula I-a or I-b”), comprising:
administering low-dose radiation to a patient suffering from a cancer (Nathanson in at least page 3 [2], page 67 [6], page 68 [1] for example discloses administering low-dose radiation to a patient suffering from a cancer. See at least page 3 [2] “methods of treating cancer comprising of administering to a subject in need of a treatment for cancer an effective amount of a compound of formula I-a or I-b”, page 67 [6] up to page 68 [1] “Radiation therapy that cause DNA damage and have been used extensively include what are commonly known as γ-rays, X-rays, and/or the directed delivery of radioisotopes to tumor cells… Dosage ranges for X-rays range from daily doses of 50 to 200 roentgens for prolonged periods of time (3 to 4 wk), to single doses of 2000 to 6000 roentgens”), whereby expression of a target inside a cancer cell of the cancer of the patient increases after the low-dose radiotherapy (Nathanson in at least page 67 [6] upto page 68 [1] for example discloses whereby expression of a target inside a cancer cell of the cancer of the patient increases after the low-dose radiotherapy. See at least page 67 [6] upto page 68 [1] “Radiation therapy that cause DNA damage and have been used extensively include what are commonly known as γ-rays, X-rays, and/or the directed delivery of radioisotopes to tumor cells… Dosage ranges for X-rays range from daily doses of 50 to 200 roentgens for prolonged periods of time (3 to 4 wk), to single doses of 2000 to 6000 roentgens”. Examiner notes that Radiation therapy increasing the expression of the target in a cancer cell is an inherent feature of radiation treatment, as also evidenced by the publication “Effects of Chronic Low-Dose Radiation on Human Neural Progenitor Cells. Sci Rep. 2016 Jan 22;6:20027.” to Katsura et al. which states in page 2 [2] “the accumulation of MDM2, a ubiquitin ligase that degenerates p53, was induced by continuous radiation in cancer cells”); and
administering a small molecule cancer therapy to the patient (Nathanson in page 54 [6] for example discloses administering a small molecule cancer therapy to the patient. See at least Nathanson page 45 [6] “methods of treating cancer comprising of administering to a subject in need of a treatment for cancer an effective amount of a glucose metabolism inhibitor and a cytoplasmic p53 stabilizer”), wherein the small molecule cancer therapy interacts with the target (Nathanson in page 44 [3] for example discloses wherein the small molecule cancer therapy interacts with the target. See at least page 44 [3] “Protein levels of p53 within cells are tightly controlled and kept low by its negative regulator, the E3 ubiquitin protein ligase MDM2. In embodiments of the methods or composition of the current disclosure, the cytoplasmic p53 stabilizer is an MDM2 antagonist/inhibitor”).
As per dependent Claim 10, Nathanson further discloses method wherein the cancer is characterized by a solid tumor (Nathanson in at least page 3 [2], page 12 [5] for example discloses cancer glioblastomamultiforme (GBM) which is characterized by a solid tumor. See at least Nathanson page 3 [2] “methods of treating cancer comprising administering to a subject in need of a treatment for cancer an effective amount of a compound of formula I-a or I-b… cancer is glioblastoma multiforme”; page 12 [5] “Gliomas are the most commonly occurring form of brain tumor, with glioblastoma multiforme (GBM) being most malignant form”).
As per dependent Claim 11, Nathanson further discloses method wherein the target is selected from the group consisting of CDKN1A (p21), DNAJB4, FNIP2, GPRASP2, GSKIP, GUCD1, HIST1H2AC, HIST1H2BC, KLF11, LIG4, MDM2, and NBR1 (Nathanson in page 44 [3] for example discloses wherein the target is selected from the group consisting of CDKN1A (p21), DNAJB4, FNIP2, GPRASP2, GSKIP, GUCD1, HIST1H2AC, HIST1H2BC, KLF11, LIG4, MDM2, and NBR1. See at least Nathanson page 44 [3] “Protein levels of p53 within cells are tightly controlled and kept low by its negative regulator, the E3 ubiquitin protein ligase MDM2. In embodiments of the methods or composition of the current disclosure, the cytoplasmic p53 stabilizer is an MDM2 antagonist/inhibitor”).
As per dependent Claim 12, Nathanson further discloses method wherein the administering comprises delivering from one dose to five doses of the low-dose radiation (Nathanson in at least page 3 [2] and page 67 [6] upto page 68 [1] for example discloses the administering comprises delivering from one dose to five doses of the low-dose radiation. See at least Nathanson page 67 [6] “Radiation therapy that cause DNA damage and have been used extensively include what are commonly known as γ-rays, X-rays, and/or the directed delivery of radioisotopes to tumor cells…Dosage ranges for X-rays range from daily doses of 50 to 200 roentgens for prolonged periods of time (3 to 4 wk), to single doses of 2000 to 6000 roentgens. Dosage ranges for radioisotopes vary widely, and depend on the half-life of the isotope, the strength and type of radiation emitted, and the uptake by the neoplastic cells.” Examiner notes that 1 roentgen deposits 0.00877 grays absorbed radiation dose, so 50 to 200 roentgens deposits 0.4385-1.754 grays absorbed radiation dose).
As per dependent Claim 14, Nathanson further discloses method further comprising: administering, to the patient, an additional cancer treatment modality other than the small molecule cancer therapy (Nathanson in at least page 37 [3] for example discloses administering, to the patient, an additional cancer treatment modality other than the small molecule cancer therapy. See at least Nathanson page 37 [3] “GBM is usually treated by combined multi-modal treatment plan including surgical removal of the tumor, radiation and chemotherapy”).
As per dependent Claim 15, Nathanson further discloses method wherein the additional cancer treatment modality is selected from the group consisting of surgical resection, immunotherapy, checkpoint inhibitor therapy, oncolytic virus therapy, thermal therapy, and two or more thereof (Nathanson in at least page 37 [3] for example discloses the additional cancer treatment modality is selected from the group consisting of surgical resection, immunotherapy, checkpoint inhibitor therapy, oncolytic virus therapy, thermal therapy, and two or more thereof. See at least Nathanson page 37 [3] “GBM is usually treated by combined multi-modal treatment plan including surgical removal of the tumor, radiation and chemotherapy”).
As per dependent Claim 23, Nathanson further discloses method wherein each dose of the low-dose radiation administered to the patient is about 0.1 Gy to about 10 Gy (Nathanson in at least page 67 [6] upto page 68 [1] for example discloses wherein each dose of the low-dose radiation administered to the patient is about 0.1 Gy to about 10 Gy. See at least Nathanson page 67 [6] “Radiation therapy that cause DNA damage and have been used extensively include what are commonly known as γ-rays, X-rays, and/or the directed delivery of radioisotopes to tumor cells…Dosage ranges for X-rays range from daily doses of 50 to 200 roentgens for prolonged periods of time (3 to 4 wk), to single doses of 2000 to 6000 roentgens. Dosage ranges for radioisotopes vary widely, and depend on the half-life of the isotope, the strength and type of radiation emitted, and the uptake by the neoplastic cells.” Examiner notes that 1 roentgen deposits 0.00877 grays absorbed radiation dose, so 50 to 200 roentgens deposits 0.4385-1.754 grays absorbed radiation dose).
As per dependent Claim 24, Nathanson further discloses method wherein each dose of the low-dose radiation administered to the patient is about 0.5 Gy to about 2 Gy(Nathanson in at least page 67 [6] upto page 68 [1] for example discloses wherein each dose of the low-dose radiation administered to the patient is about 0.5 Gy to about 2 Gy. See at least Nathanson page 67 [6] “Radiation therapy that cause DNA damage and have been used extensively include what are commonly known as γ-rays, X-rays, and/or the directed delivery of radioisotopes to tumor cells…Dosage ranges for X-rays range from daily doses of 50 to 200 roentgens for prolonged periods of time (3 to 4 wk), to single doses of 2000 to 6000 roentgens. Dosage ranges for radioisotopes vary widely, and depend on the half-life of the isotope, the strength and type of radiation emitted, and the uptake by the neoplastic cells.” Examiner notes that 1 roentgen deposits 0.00877 grays absorbed radiation dose, so 50 to 200 roentgens deposits 0.4385-1.754 grays absorbed radiation dose ).
Claim 16 is rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Reisner et al. (Pub. No.: US 20180207272 A1, hereinafter referred to as “Reisner”).
As per independent Claim 16, Reisner discloses a kit (Reisner in at least abstract, [0018], [0070], [0099], [0181], [0348-0349], [0357-0367], [0371], [0414-0416], [0434], [0436] for example discloses relevant subject-matter. More specifically, Reisner in at least [0357] for example discloses a kit. See at least Reisner [0357] “”; [0358] “Compositions of some embodiments of the invention may, if desired, be presented in a pack or dispenser device, such as an FDA approved kit, which may contain one or more unit dosage forms containing the active ingredient… pack or dispenser device may be accompanied by instructions for administration.”), comprising: a cell-based cancer therapy composition specific for an extracellular target or an intracellular target of a cancer cell of a patient suffering from cancer (Reisner in at least [0018] for example discloses a cell-based cancer therapy composition specific for an extracellular target or an intracellular target of a cancer cell of a patient suffering from cancer. See at least Reisner [0018] “there is provided an isolated cell having a central memory T-lymphocyte (Tcm) phenotype, the cell being tolerance-inducing cell and capable of homing to the lymph nodes following transplantation, the cell being transduced to express a chimeric antigen receptor (CAR).”); and instructions for the use of the cancer therapy composition in a method comprising administering low-dose radiation to a patient suffering from a cancer (Reisner in at least [0348-0349], [0357-0358], [0415-0416] for example discloses instructions for the use of the cancer therapy composition in a method comprising administering low-dose radiation to a patient suffering from a cancer. See at least Reisner in [0357] “Compositions of some embodiments of the invention may, if desired, be presented in a pack or dispenser device, such as an FDA approved kit, which may contain one or more unit dosage forms containing the active ingredient…The pack or dispenser device may be accompanied by instructions for administration.”; [0415] “the TBI comprises a single or fractionated irradiation dose within the range of 0.5-1 Gy, … or 10-15 Gy.”; [0416] “the TBI comprises a single or fractionated irradiation dose within the range of 1-7.5 Gy”), whereby expression of a target on a surface of a cancer cell of the cancer of the patient increases after the low-dose radiation (Reisner in at least [0414] for example discloses whereby expression of a target on a surface of a cancer cell of the cancer of the patient increases after the low-dose radiation. See at least Reisner [0414] “the sublethal, lethal or supralethal conditioning comprises total body irradiation (TBI), total lymphoid irradiation (TLI, i.e. exposure of all lymph nodes, the thymus, and spleen), partial body irradiation”); and administering the cell-based target-specific cancer therapy to the patient, wherein a cell of the cell-based cancer therapy interacts with the target (Reisner in at least [0018], [0349] for example discloses administering the cell-based target-specific cancer therapy to the patient, wherein a cell of the cell-based cancer therapy interacts with the target.See at least Reisner [0018] “there is provided an isolated cell having a central memory T-lymphocyte (Tcm) phenotype, the cell being tolerance-inducing cell and capable of homing to the lymph nodes following transplantation, the cell being transduced to express a chimeric antigen receptor (CAR)”; [0349] “The amount of a composition to be administered will, of course, be dependent on the subject being treated, the severity of the affliction, the manner of administration, the judgment of the prescribing physician, etc.”).
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 of this title, 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Chinnasamy.
As per dependent Claim 5, Chinnasamy discloses method of claim 4 (see Claim 4 analysis above),
Chinnasamy does not necessarily and explicitly require two to three doses of the low-dose radiation feature in the applied embodiment.
However, Chinnasamy disclosure makes obvious wherein the administering comprises delivering from two to three doses of the low-dose radiation(First, Examiner notes that the instant application is silent as to the criticality of the recited number of doses as evidenced in at least instant application specification as-filed [0073]. Further, Chinnasamy’s disclosure in page 3372 col. 2 para. [2] stating “they were irradiated with 5 Gy of total-body irradiation (TBI)” makes recited subject-matter obvious to a one of ordinary skill in the art before the effective filing date of the claimed invention as a matter of optimization within prior art conditions or as a matter of mere routine experimentation (see MPEP 2144.05) in order to optimize dosage to effectively treat the solid tumor ).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the number of doses of the low-dose radiation administered in the method as taught by Chinnasamy, such that the number of doses of the low-dose radiation administered is from two to three doses, as made obvious by Chinnasamy . A person of ordinary skill would have been motivated to do so as a matter of mere optimization within prior art conditions or as a matter of mere routine experimentation (see MPEP 2144.05), with a reasonable expectation of success, for the advantage of optimizing dosage to effectively treat the solid tumor (Chinnasamy, abstract, page 3378).
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Nathanson.
As per dependent Claim 13, Nathanson discloses method of claim 12 (see Claim 12 analysis above),
Nathanson does not necessarily and explicitly require two to three doses of the low-dose radiation feature in the applied embodiment.
However, Nathanson disclosure makes obvious wherein the administering comprises delivering from two to three doses of low-dose radiation (Examiner notes that the instant application is silent as to the criticality of the recited number of doses as evidenced in at least instant application specification as-filed [0073]. Nathanson’s disclosure in at least page 3 [2] and page 67 [6] upto page 68 [1] for example stating “Dosage ranges for X-rays range from daily doses of 50 to 200 roentgens for prolonged periods of time (3 to 4 wk), to single doses of 2000 to 6000 roentgens. Dosage ranges for radioisotopes vary widely, and depend on the half-life of the isotope, the strength and type of radiation emitted, and the uptake by the neoplastic cells.” makes recited subject-matter obvious to a one of ordinary skill in the art before the effective filing date of the claimed invention as a matter of optimization within prior art conditions or as a matter of mere routine experimentation (see MPEP 2144.05) in order to optimize dosage to effectively treat the subject’s tumor responsive to the uptake by the neoplastic cells).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the number of doses of the low-dose radiation administered in the method as taught by Nathanson, such that the number of doses of the low-dose radiation administered is from two to three doses, as made obvious by, as made obvious by Nathanson. A person of ordinary skill would have been motivated to do so, with a reasonable expectation of success, for the advantage of optimize dosage to effectively treat the subject’s tumor responsive to the uptake by the neoplastic cells (Nathanson, page 67 [6] upto page 68 [1]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure and/or the claims. Prior arts US 20210079102, US 20180250404, US 20060127311, US 20140155678, US 20230099010, US 20140088408, US 20180126012, US 20170360932 for disclosing tumor/cancer combination therapy that combines targeted tumor/cancer cell-based treatment and radiation similar to that disclosed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SUNITA REDDY whose telephone number is (571)270-5151. The examiner can normally be reached on M-Thu 10-4 EST.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, CHARLES A MARMOR II can be reached on (571)272-4730. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SUNITA REDDY/Primary Examiner, Art Unit 3791