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 .
Applicant’s remarks, filed 7/8/2026, are acknowledged and entered into the record. Applicants amended claims 1-2, 5-6 and 20; and canceled claim 23, in the remarks of 7/8/2026.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 7/8/2026 has been entered.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(a)-(d) and (f) or under 35 U.S.C. 120, 121, 365(a) or (b), or 386(a) is acknowledged. The present application is drawn from PCT/CN2021/091341, filed 4/30/2021; and claims benefit under 35 U.S.C. (119(a)-(d) to foreign application CN202010366867.4, filed 4/30/2020. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55. Receipt of an English translation of CN202010366867.4, filed 2/2/2026, is acknowledged. The priority date for the instant claims is 4/30/2020.
Status of Claims
Claims 1-2, 4-6, 20 and 25-26 are pending and are being examined on the merits.
Claim Rejections – Withdrawn
Claim Rejections - 35 USC § 112(b)
The rejection of claims 1-2, 4, 20, 23 and 25-26 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention, is withdrawn.
Applicants amended claim 1 to obviate the rejections for lack of antecedent basis. Applicants amended claim 20 to limit the treatment to subjects in need, thus obviating the indefiniteness issues related to whether the principle targets of the treatment methods are subjects with cancer or cellular compositions.
Claim Rejections - 35 USC § 103
The rejection of claims 1-2, 4-6, 20, 23 and 25-26 under 35 U.S.C. 103 as being unpatentable over Miller et al., (from IDS, Cite No. 4; WO 2019/221991; published 11/21/2019), is withdrawn. Specifically, applicants amended claims 1 and 5 to require that the cells are treated with a magnetic field. Miller teaches genetic engineering to upregulate Uqcrb expression, and does not contemplate magnetic field stimulation; thus Miller does not teach all the limitations of the amended claims.
Claim Objections
Claim 5 is objected to because of the following informalities: Claim 5, line 4, recites “comprises one or more steps”. This should be “comprising one or more steps”. Appropriate correction is required.
Claim 25 is objected to because of the following informalities: Claim 25, line 4 recites “pancreatic cancer, and prostate cancer, and melanoma.” The claim recites a list of alternative cancers. The “and” before prostate cancer should be removed, as prostate cancer is not the last alternative of the group. Appropriate correction is required.
Claim 26 is objected to because of the following informalities: Claim 26 recites “wherein the cancer is a hematological tumor selected from the group consisting of lymphomas selected from the group consisting of B cell lymphomas and mantle cell lymphomas; and leukemias selected from the group consisting of acute lymphoblastic leukemias,”. This is grammatically awkward. The claims should recite the first “group consisting of” before further reciting additional groups consisting of.
For example, the claim should recite “a hematological tumor selected from the group consisting of lymphomas and leukemias; wherein the lymphomas are selected from the group consisting of B cell lymphomas and mantle cell lymphomas, and the leukemias are selected from the group consisting of acute lymphoblastic leukemias,” etc. Appropriate correction is required.
Claim Interpretation
Amended claim 1 is drawn to an activated CD8+ T cell which has specific properties upregulated, including increased Uqcrb and Ndufs6 gene activity, increased secretion of perforin or granzymes, and thus increased cell killing capacity. However, claim 1 recites method steps to generating the cell, including exposure to magnetic fields with specific parameters regarding magnetic field strength and duration of exposure. The examiner is interpreting claim 1 as being drawn to a product-by-process, whereby the claimed cells have necessarily been exposed to a magnetic field, and thus are distinct from alternatively activated CD8+ T cells that have not been exposed to a magnetic field. Thus, the examiner interprets the product of claim 1 to be drawn to “a magnetic field-treated, activated CD8+ T cell,” which comprises the altered gene activity profile, the increased expression of perforin and/or granzymes and thus the enhanced killing capacity.
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 1-2 and 4 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites a magnetic field-treated activated CD8+ T cell characterized by upregulated expression or activity of mitochondrial respiratory chain related genes Uqcrb and Ndufs6 relative to wild-type immune cells, wherein magnetic related genes of the immune cell, Isca1, Cry 1, and/or Cry2 are involved in regulating the expression or activity of the Uqcrb and Ndufs6 genes. While it is clear that Uqcrb and Ndufs6 genes are upregulated, it is unclear what parameters define the alterations of Isca1, Cry1 and/or Cry2, such that they are “involved” in regulating downstream activity of Uqcrb and Ndufs6 genes. Are the Isca1, Cry1 and/or Cry2 genes upregulated or downregulated? To what degree must their activity/expression be altered? To what control measure is their altered activity to be compared and quantified? What defines being “involved” in downstream molecular activity; or conversely, if their activity is innate to downstream molecular activity, what defines not being “involved”? Applicants must particularly point out and distinctly claim the subject matter, such that the claim limitations are clearly defined. Here, the terminology “are involved” is without any parametric boundaries, or meaning. Thus, the metes and bounds of the claim limitation are unclear and the skilled artisan cannot be sure what is and what is not encompassed by the claim.
Further, the “increased expression or secretion of perforin and/or granzymes” lacks parametric definition. Are they increased compared to non-activated CD8+ T cells, or compared to activated CD8+ T cells that were not treated by magnetic field stimulation? Similarly, the limitation of “wherein the cell has an enhanced cell killing capacity” lacks definition. Is the enhanced cell killing capacity compared to non-activated CD8+ T cells, or is the comparison to the killing capacity of activated, but not magnetic field treated, CD8+ T cells? Does the treatment with a magnetic field generate a killing capacity phenotype that extends cytotoxic activity beyond that of innately activated native CD8+ T cells? If so, what parameters define the “enhanced” capacity for cell killing that was generated by the magnetic field stimulation; that is, what is required to meet the limitation of having an “enhanced” capacity for cell killing? The metes and bounds of the claim limitations are unclear, thus rendering the claim indefinite. Claim 1 is rejected for indefiniteness. As claims 2 and 4 depend from claim 1, but fail to rectify the indefiniteness issues, they are also rejected.
Allowable Subject Matter
Claims 5-6, 20 and 25-26 are allowed.
The following is a statement of reasons for the indication of allowable subject matter: Regarding claims 5, 6, 20, and 25-26. While various methods of treating cancer comprising exposing the subject to a magnetic field are generally described in the art, including using MRI machines or having the subject wear magnetic bracelets, the methods are aimed at inducing apoptosis of the tumor cells directly. Alternatively, the instant methods are intended to target tumor cell indirectly, by enhancing CD8+ T cell cytotoxic activity against the tumor cells. Thus, the prior art regarding treating a subject with a magnetic field does not describe the specific limitations of applying a static magnetic field, of 0.3 T – 0.6 T strength, for 48-72 hours, of the instant claims. It would not have been obvious for the skilled artisan to derive a method encompassing these specific parameters of exposure in a method for treating cancer, as these parameters do not have deleterious effects on tumor cells directly. The closest prior art would be Lin et al., (Electromagnetic Biology and Medicine, 2019) which demonstrated that magnetic field exposure enhances NK cell cytotoxicity against cancer cells, in vitro. However, Lin does not teach the effect on CD8+ T cells specifically, and Lin references that magnetic field exposure has differential effects (or no effect) across different cellular phenotypes, such that it is not obvious that CD8+ T cells would respond to magnetic field exposure in the same way as NK cells.
Conclusion
Claims 1-2 and 4 are rejected; claims 5-6, 20 and 25-26 are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAMES R. MELCHIOR whose telephone number is (703)756-4761. The examiner can normally be reached M-F 8:00-5:00 CST.
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/JAMES RYLAND MELCHIOR/Examiner, Art Unit 1644
/NELSON B MOSELEY II/Primary Examiner, Art Unit 1642
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