DETAILED ACTION
Claims 21-28 are currently pending. Claims 1-20 are cancelled.
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 .
Priority
Acknowledgement is made of the instant application being a national stage entry under 35 USC 371 of international application PCT/JP2023/017460, filed May 9, 2023, which claims the benefit of provisional applications No. 63/344,860, filed May 23, 2022 and application No. 63/492,196, filed March 24, 2023.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on November 22, 2024, December 3, 2024, May 2, 2025, and September 18, 2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Claim Objections
Applicant is advised that should claim 23 be found allowable, claim 25 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
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 (i.e., changing from AIA to pre-AIA ) 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.
Claim(s) 27-28 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Romagne et al., (US 2005/0196385; see PTO-892) (“Romagne”).
Regarding claims 27-28, it is initially noted that claims 27 and 28 claim the following:
27. γδ T cells induced from pluripotent stem cells derived from γδ T cells.
28. A pharmaceutical composition for cancer treatment, comprising γδ T cells induced from pluripotent stem cells derived from γδ T cells.
As to claim 27 and the limitation that the γδ T cells are induced from pluripotent stem cells derived from γδ T cells, it is noted this limitation is directed to the manner by which the claimed γδ T cells are produced.
Such limitations are product-by-process limitations which appear to define the γδ T cells. Product-by-process limitations are considered only insofar as the method of production imparts distinct structural or chemical characteristics or properties to the product. Therefore, if the product, as claimed, is the same or obvious over a product of the prior art (i.e., it is not structurally or chemically distinct), the claim is considered unpatentable over the prior art, even though the prior art product is made by a different process. In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985), and In re Garnero, 412 F.2d 276, 279, 162 USPQ 221, 223 (CCPA 1979). See also MPEP § 2113.
In the instant case, the method by which the γδ T cells have been produced is not sufficiently detailed so as to impart any unique structural/chemical properties to the γδ T cells. Thus, any composition comprising γδ T cells would appear to read on the γδ T cells recited in claim 27.
Likewise, regarding claim 28 and the limitation that the γδ T cells are induced from pluripotent stem cells derived from γδ T cells, said limitation is directed to the manner by which the composition has been prepared and as noted above regarding claim 27, the method by which the γδ T cells have been produced is not sufficiently detailed so as to impart any unique structural/chemical properties to the γδ T cells. Thus, any composition comprising γδ T cells would appear to read on the γδ T cells recited in claim 28.
It is further noted that claim 28 recites the phrase “for cancer treatment”. Given that claim 28 is directed to a composition, per se, said limitation is interpreted as being directed to the intended use of the claimed composition, which does not further define or limit the composition. Please note that it is well settled that “intended use” of a composition or product, e.g., “for cancer treatment”, will not further limit claims drawn to a composition or product, so long as the prior art discloses the same composition as that instantly claimed. See, e.g., Ex parte Masham, 2 USPQ2d 1647 (1987) and In re Hack 114, USPQ 161. In this case the body of the claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states the intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, thus the preamble is properly not considered a limitation and is of no significance to claim construction. See MPEP 2111.02
Romagne is directed to methods for producing lymphocytic cells, particularly for preparing functional gamma delta T cells (γδ T cells) of pharmaceutical quality (i.e., a pharmaceutical composition) and in large amounts, wherein the composition comprises more than 90% gamma delta T cells (Abstract; [0006]-[0007]; claims 21 and 34).
Claim 46 of Romagne claims the following:
46. A composition comprising a population of cells comprising more than 80% functional gamma delta T lymphocytes and comprising more than 100 million gamma delta T lymphocytes and a carrier or excipient.
Thus, Romagne anticipates claims 27 and 28.
Claim(s) 27-28 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Kaneko et al., (US 2021/0130777, published May 6, 2021; see PTO-892) (“Kaneko”).
As discussed above, the method by which the γδ T cells have been produced is not sufficiently detailed so as to impart any unique structural/chemical properties to the γδ T cells. Thus, any composition comprising γδ T cells would appear to read on the γδ T cells recited in claims 27 and 28.
Further regarding claim 28, as set forth above regarding the phrase “for cancer treatment”, given that claim 28 is directed to a composition, per se, said limitation is interpreted as being directed to the intended use of the claimed composition, which does not further define or limit the composition. Please note that it is well settled that “intended use” of a composition or product, e.g., “for cancer treatment”, will not further limit claims drawn to a composition or product, so long as the prior art discloses the same composition as that instantly claimed. See, e.g., Ex parte Masham, 2 USPQ2d 1647 (1987) and In re Hack 114, USPQ 161. In this case the body of the claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states the intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, thus the preamble is properly not considered a limitation and is of no significance to claim construction. See MPEP 2111.02
Regarding claims 27 and 28, Kaneko is directed to methods for producing γδ T cells (gamma delta T cells) from induced pluripotent stem cells, wherein the induced pluripotent stem cell is derived from a cell other than αβ T cell, and the induced pluripotent stem cells are thereafter induced to differentiate back to γδ T cells. Kaneko teaches the produced T cells show high cytotoxicity to cancer cells (Abstract and [0006]-[0007]). Kaneko specifically teaches a composition comprising a cell population in which not less than 90% of all cells are γδT cells, wherein the γδT cell is a cell differentiated from an induced pluripotent stem cell derived from a cell other than an αβT cell, and the cells are used for treating cancer ([0007]).
Kaneko anticipates claims 27 and 28.
Claim Rejections - 35 USC § 103
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 (i.e., changing from AIA to pre-AIA ) 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 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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(s) 21-26 are rejected under 35 U.S.C. 103 as being unpatentable over Kaneko et al., (US 2021/0130777; see PTO-892) (“Kaneko”).
Regarding claims 21 and 22, Kaneko is directed to methods for producing γδ T cells (gamma delta T cells) from induced pluripotent stem cells, wherein the induced pluripotent stem cell is derived from a cell other than αβ T cell, and the induced pluripotent stem cells are thereafter induced to differentiate back to γδ T cells. Kaneko teaches the produced T cells show high cytotoxicity to cancer cells (Abstract and [0006]-[0007]). Kaneko specifically teaches a composition comprising a cell population in which not less than 90% of all cells are γδT cells, wherein the γδT cell is a cell differentiated from an induced pluripotent stem cell derived from a cell other than an αβT cell, and the cells are used for treating cancer ([0007]).
Kaneko, at [0007], specifically teaches the method comprises:
(1) a step for establishing an induced pluripotent stem cell from a cell other than an αβT cell, and
(2) a step for differentiating the induced pluripotent stem cell established in step (1) into a T cell.
Kaneko teaches the cell other than an αβT cell is a mononuclear cell other than an αβT cell, wherein the cell other than an αβT cell is a monocyte.
The method further includes introducing into the T cells a nucleic acid encoding γTCR and a nucleic acid encoding δTCR which recognizes and binds to a tumor-specific antigen or a tumor-associated antigen, specifically wherein the γTCR is Vγ9TCR and the δTCR is Vδ2TCR.
The only difference between the instant claim and the teaching of Kaneko is that Kaneko, at [0007], discloses the induced pluripotent stem cell from a cell other than an αβT cell is a monocyte and does not further teach the induced pluripotent stem cell from a cell other than an αβT cell is a T cell (claim 21) or derived from γδT cells (claim 22).
However, Kaneko at paragraph [0035] teaches the somatic cells for induction to pluripotent stem cells include mononuclear cells such as γδT cells.
Thus, Kaneko does render obvious a method for producing γδT cells , comprising inducing differentiation of γδT cells from pluripotent stem cells derived from T cells, specifically γδT cells (claims 21 and 22), that is, Kaneko teaches the limitations required by the current claims and as all limitations are found in one reference it is held that a a method for producing γδT cells , comprising inducing differentiation of γδT cells from pluripotent stem cells derived from T cells, specifically γδT cells is within the scope of the teachings of Kaneko, and thus renders the invention of claims 21 and 22 prima facie obvious. The rationale to support this conclusion of obviousness is that the single reference provides the teachings and suggestion to produce γδT cells, comprising inducing differentiation of γδT cells from pluripotent stem cells derived from T cells, specifically γδT cells. Furthermore, there is no evidence on the record that shows that the claimed limitation has any greater or unexpected results than that exemplified by Kaneko.
Regarding claims 23-25, Kaneko at [0007] teaches introducing into the T cells a nucleic acid encoding γTCR and a nucleic acid encoding δTCR which recognizes and binds to a tumor-specific antigen or a tumor-associated antigen, specifically wherein the γTCR is Vγ9TCR and the δTCR is Vδ2TCR, thus meeting the limitations of claims 23-25.
Regarding claim 26, Kaneko (at paragraphs [0042]-[0045]) teaches the differentiation of the induced pluripotent stem cells comprises differentiation into hematopoietic progenitor cells and thereafter continuing differentiation to achieve the final product comprising γδT cells.
Thus, Kaneko does render obvious a method for producing γδT cells , comprising inducing hematopoietic progenitor cells from said pluripotent stem cells, and inducing differentiation of the hematopoietic progenitor cells to γδT cells, that is, Kaneko teaches the limitations required by the current claims and as all limitations are found in one reference it is held that a method for producing γδT cells, comprising inducing hematopoietic progenitor cells from said pluripotent stem cells, and inducing differentiation of the hematopoietic progenitor cells to γδT cells is within the scope of the teachings of Kaneko, and thus renders the invention of claim 26 prima facie obvious. The rationale to support this conclusion of obviousness is that the single reference provides the teachings and suggestion to produce γδT cells, comprising inducing hematopoietic progenitor cells from said pluripotent stem cells, and inducing differentiation of the hematopoietic progenitor cells to γδT. Furthermore, there is no evidence on the record that shows that the claimed limitation has any greater or unexpected results than that exemplified by Kaneko.
Conclusion
No claim is allowed. No claim is free of prior art.
Examiner Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to E. YVONNE PYLA whose telephone number is (571)270-7366. The examiner can normally be reached M-F 9am - 6pm.
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E. YVONNE PYLA
Primary Examiner
Art Unit 1633
/EVELYN Y PYLA/ Primary Examiner, Art Unit 1633
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