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 .
Election/Restrictions
Applicants’ election with traverse of Group I in the reply filed on 6/11/2026 is acknowledged. The traversal is on the ground(s) that the claimed invention is patentable over the cited D’Alessio document. This is not found persuasive because Applicant has not provided any arguments or evidence regarding any deficiencies or errors in the restriction mailed on 3/11/2026.
The requirement is still deemed proper and is therefore made FINAL.
Claims 29-32 and 36 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 6/11/2026.
Claims 1, 13-17, 19-24 and 26-28 are examined in the instant application.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claim 28 is rejected under 35 U.S.C. 101 because the claimed invention is not directed to patent eligible subject matter. Based upon an analysis with respect to the claim as a whole, claims do not recite something significantly different than a judicial exception. The rationale for this determination is explained below.
The Claims
The claims are directed to:
A cell of any species obtained by the method of claim 1.
Teachings in the Art
Regarding claim 28, the art teaches that cells such as CD4 or CD8 cells occur naturally in the thymus (see Takahama et al., 1994, J. Exp. Med., Vol. 179, pgs. 1495-1506).
Teachings in the Specification
The specification teaches in Example 2 the transdifferentiation of somatic cells into a variety of cells types including, CD4 or CD8 positive T cells. However, the claimed cell, while being obtained from a parent cell (somatic cell) exposed to a cocktail of transcription factors, does not have any modification(s) that would markedly distinguish it from its naturally occurring counterpart. While the claimed cell was obtained from an in vitro transdifferentiation method, the claimed cell recites no structural or functional feature that would distinguish it from a cell that occurs in nature.
Accordingly, the claim is directed to a composition using only a nature-based product, i.e., a cell, this nature-based product is then analyzed to determine whether it has markedly different characteristics from any naturally occurring counterpart(s) in their natural state. The claims thus encompass a cell which is identical (no difference in characteristics) to a naturally occurring cell such as a CD4+ cell.
Because there is no difference between the cell used in the claimed composition, the claimed cell does not have markedly different characteristics, and thus are is “product of nature” exception. In re Roslin Institute (Edinburgh), 750 F.3d 1333, 1338-39 (Fed. Cir. 2014). Accordingly, the claimed cell is directed to an exception. Because the claimed cell does not include any additional features that could add significantly more to the exception, the claimed cell does not qualify as eligible subject matter, and should be rejected under 35 U.S.C. § 101.
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An examination of Step 2A in the revised 101 guidance, with respect to the claimed invention, the answer is yes since the claimed cell comprises only a naturally occurring product (judicial exceptions), in the instant case this naturally occurring product is a cell.
It is only the recited limitations in the claims that are examined under 101 and not aspects such as what the cells are capable of being used for (i.e. for use in transplantation). In this case only a cell is examined with respect its status as a judicial exception. It is emphasized that the claimed invention is a composition and not a method.
An examination of Step 2B, the answer is no with respect to the claimed invention. There are no other additional elements recited in the claim that would amount to significantly more than the judicial exceptions. This is because while the claimed invention is drawn to cell, there are no additional components which impart any additional element or structural limitations to the recited cell. The cell of the claim is indistinguishable from a cell that exists in nature. The cell of the claim has the same capability a cell that exist in nature and the fact its is produced by a specific method does not change the cell in significant or meaningful way to amount to more than the judicial exception.
The only factors which can be examined under 101 in the claimed composition are those that are recited in the claim i.e. a cell.
How the claimed cell is obtained and the knowledge of using said cell is not considered with respect to a composition, it is only the judicial exceptions themselves that are analyzed under 101 and in this case all of the components in the claimed cell is a naturally-occurring product and thus qualify as a judicial exception.
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.
Claim(s) 1, 13, 17, 19-24, 26 and 28 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by D’Alessio et al. (US 2017/0002319 A1) and evidenced by the teachings of Devi et al. (2017, J. Clinical and Diag. Res., Vol. 11(5), pgs. ZC84-ZC86).
Regarding claims 1, 13 and 28, D’Alessio et al. teach a method comprising providing a somatic cell (i.e. immune), inducing expression with Tbx21, Tcf7 and Ets1 and incubating the cell to allow transdifferentiation (see Abstract, parags. 128/133 and Table 1A).
Regarding claims 17, 19 and 21, D’Alessio teaches that the cell can be a mesenchymal stem cell (Fig. 6E and parags. 128/133).
Regarding claim 20, D’Alessio teaches that the cell can be skin fibroblast (see Abstract and parag. 80).
Regarding claim 22, D’Alessio teaches that the cell can be a memory T cell (parag. 150). In this regard the teachings of Devi et al. who teach that memory T cells inherently express CD45.
Regarding claims 23 and 24, it is art recognized that memory B cells (parag. 150) do not express CD105. Further with respect to claim 23, it is art recognized that somatic cells such as endothelial cells (parag. 133) inherently express CD105. Thus the memory B cells, which do not express CD105, would meet the limitations of claim 23.
Regarding claim 26, D’Alessio teaches that the nucleic acid encoding the transcription factor is operably linked to a promoter (parag. 96).
Thus the teachings of D’Alessio clearly anticipate the invention of claims 1, 13, 17, 19-24, 26 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.
Claim(s) 1, 14-16 and 27 is/are rejected under 35 U.S.C. 103 as being unpatentable over by D’Alessio et al. (US 2017/0002319 A1) in view of Vodyanyk et al. (WO 2018/067836 A1).
Regarding claim 1, D’Alessio et al. teach a method comprising providing a somatic cell (i.e. immune), inducing expression with Tbx21, Tcf7 and Ets1 and incubating the cell to allow transdifferentiation (see Abstract, parags. 128/133 and Table 1A).
D’Alessio does not teach:
γΔ, CD4 and CD8 T cells and electroporation.
Regarding γΔ, CD4 and CD8 T cells and electroporation, Vodyanyk et al. teach
method of transdifferentation (parags. 78/79) of somatic cells via electroporation (para. 147) into either γΔ, CD4 or CD8 T cells (parags. 73-75).
Thus at the time of filing the ordinary artisan would have found it prima facie obvious to combine the teachings of D’Alessio regarding a method of transdifferentiating a somatic cell into an immune cell with transcription factors with the teachings of Vodyanyk regarding producing γΔ, CD4 and CD8 T cells via transdifferentiation to arrive at the claimed method.
One of ordinary skill in the art would have been motivated to make such a combination since D’Alessio teaches that their method can make an immune cell and Vodyanyk teaches that a variety of immune cells such as γΔ, CD4 and CD8 T cells can be produced via transdifferentaiton through the electroporation of a nucleic acid.
There would have been a reasonable expectation of success that the immune cell of D’Allessio could be transdifferentiated into a γΔ, CD4 or CD8 T cell since Vodyanyk teaches that γΔ, CD4 and CD8 T cells can be produced via transdifferentiation of somatic cells.
Thus the cited art provides the requisite teachings and motivations to make and use the invention as claimed.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVID A MONTANARI whose telephone number is (571)272-3108. The examiner can normally be reached M-Tr 8-6.
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/DAVID A MONTANARI/Examiner, Art Unit 1632
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