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 .
DETAILED ACTION
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office Action has been withdrawn pursuant to 37 CFR 1.114.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 September 10, 2025 has been entered.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Please note: The terminal disclaimer filed 10 June, 2025, has not been accepted, as per the decision of 16 June, 2025.
Status of Claims
This action is in response to the papers filed on September 10, 2025. Claim 1 is currently pending. Claim 1 has been amended in the Applicant’s amendment filed September 10, 2025. Claims 2 and 9 have been canceled by the Applicant’s amendment filed September 10, 2025. No claims have been added by the Applicant’s amendment filed September 10, 2025. (Note: Claims 3 – 8, and 10 – 42 were previously canceled).
Applicant's election of Group I, claims 1, 2, 9 – 17, 27, 32 – 36, and 42, directed to a population of T cell expressing a CAR; and the election of Species as follows:
Species (A): wherein the population of T cells comprises a genetic alteration to reduce immunogenicity against a host (instant claim 33),
Species (B): wherein the population of T cells ha a greater percentage of cells expressing CD45RA (instant claim 9);
Species (C): where the gene knockout is a TCR knockout (instant claim 35), was previously acknowledged in the response filed October 1, 2024.
Because applicant did not distinctly and specifically point out the supposed errors in the
restriction requirement, the election of invention has been treated as an election without traverse (MPEP § 818.03(a)). The restriction requirement between Groups 1 and 2 was previously made final by the examiner in the office action filed on 10/1/2024.
The claims will be examined insofar as they read on the elected species.
Therefore, claim 1 is under consideration to which the following grounds of rejection are applicable.
Priority
The present application filed May 27, 2021, is a 35 U.S.C. 371 national stage filing of International Application No. PCT/US2019/064074, filed December 2, 2019, which claims the benefit of Provisional Application 62/878,736, filed July 25, 2019, which claims the benefit of Provisional Application 62/774,142, filed November 30, 2018.
Thus, the earliest possible priority for the instant application is November 30, 2018.
Withdrawn Objections/Rejections
Applicants’ amendment and arguments filed September 10, 2025 are acknowledged and have been fully considered. The Examiner has re-weighed all the evidence of record. Any rejection and/or objection not specifically addressed below are herein withdrawn.
Nonstatutory Double Patenting Rejection
The rejection of instant claims 1, 2, and 9 as being provisionally rejected on the grounds of nonstatutory obviousness-type double patenting of the claims of copending Application No. 17830865 is withdrawn.
Claim 1 has been amended to recite the phenotypes of the T cells and the knockout of the TRAC portion of the CD3 gene. These claims no longer read on copending Application No. 17830865
In view of the withdrawn rejection, Applicants argument is moot.
Claim Rejection - 35 USC § 103
The rejection of claims 1, 2, and 9 under 35 U.S.C. 103 as being unpatentable over Bedoya et al. (hereinafter referred to as “Bedoya”) (WO/2017/015427, published Jan 26, 2017), and further in view of Dzierzak and Robin. (hereinafter referred to as “Robin”) (Dzierzak E, Robin C. Placenta as a source of hematopoietic stem cells. Trends Mol Med. 2010 Aug;16(8):361-7. doi: 10.1016/j.molmed.2010.05.005. Epub 2010 Jun 30. PMID: 20580607; PMCID: PMC3586314.) is withdrawn.
Claim 1 has been amended to recite the phenotypes of the T cells and the knockout of the TRAC portion of the CD3 gene. Bedoya and Robin do not teach these limitations.
In view of the withdrawn rejection, Applicant’s arguments are moot.
Maintained Objections/Rejections
Claim Rejection - 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.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 1 remain 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 is indefinite for the recitation of “T cells of said population have a phenotype that is (i) naïve” in lines 3, and “said T cells are modified” in line 5. It is unclear what the phenotype of the T cells is, and whether they have been modified or not. A person of ordinary skill in the art would understand that a “naïve” T cell is one that has not been modified. Thus, it is unclear whether the T cells of the T cell population can simultaneously be modified and “naïve.” Accordingly, the metes and bounds of the claim cannot be determined.
Claim 1 is indefinite for the recitation of “most T cells of said population” in line 5. It is unclear and indefinite what constitutes “most T cells.” Thus, the metes and bounds of the claim cannot be determined.
Claim 1 is indefinite for the recitation of “the percentage of cells of said population of placenta derived T cells that express CD45R is greater than the percentage of cells of a population of peripheral blood mononuclear cells T cells that express CD45RA” in lines 7 – 9. It is unclear what is the difference between the “CD45R” and the “CD45RA,” as the as-Filed Specification only teaches “CD45RA” (Paragraph [0083]) and [0044]). Also note that the Specification discloses at para [0091] that placenta-derived T cells (P-T cells) exhibited a distinct T cell differentiation phenotype as compared to CD 19 CAR PBMC-derived T cells “P-T cells consisted of a nice mix of CD3+ CD45RA+ CCR 7+ naive/ stem cell memory T cells and CD3+ CD45RA+ CCR7- effector T cells, while PBMC-derived CD19 CART cells consisted mostly of CD3+ CD45RA- CCR7- effector memory T cells and CD3+ CD45RA+ CCR7- effector T cells”. The as-Filed Specification does not teach “CD45R.” For the purpose of a compact prosecution the term “CD45R” recited in claim 1 has been interpreted as “CD45RA.”
Claim 1 indefinite for the recitation of “CD3+CD56- T cells” in line 4, and “they have a TRAC portion of a T cell receptor CD3 gene knocked out” in lines 6 – 7. Initially, it is unclear how a portion of a gene can be knocked out. A person of ordinary skill in the art would know that if the TRAC portion of the CD3 has been knocked out, the entire CD3 gene has been effectively knocked out. Further, it is unclear how these T cells can be both CD3+ and be knocked out for CD3. Accordingly, the metes and bounds of the claim cannot be determined.
New Rejections
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 1 is rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. This is a new rejection necessitated by the amendment made to the claims filed January 10, 2025.
Claim 1 is drawn to a population of T cells produced from the expansion of T cells, wherein the T cells are isolated from cord blood placenta or placenta perfusate, the T cells of this population have a particular phenotype, and these T cells are modified to express a CAR and have the TRAC portion of CD3 gene knocked out.
None of the subject matter of claim 1 is necessarily isolated.
Given the disclosure it is evident that the claimed T cell comprising the claimed modifications is intended for use in treating hematological and solid cancers, and administering the composition to the subject (see e.g. paragraphs [0005], [0027], [0029] of the as-Filed Specification).
Once administered to a human patient, the engineered T cells become integral parts of a living human being. Accordingly, the claims, construed in this manner, are directed to non-patentable subject matter, namely a human being. Inasmuch as the claims may be broadly but reasonably construed as encompassing a living human, Applicant is duly reminded that Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Accordingly, claims 1 is also rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101). See M.P.E.P. § 2105, which states:
If the broadest reasonable interpretation of the claimed invention as a whole encompasses a human being, then a rejection under 35 U.S.C. 101 must be made indicating that the claimed invention is directed to nonstatutory subject matter.
It is suggested that this issue may best be remedied by amending the claims to recite the limitation, “a population of isolated T cells produced by expanding T cells isolated from….” . See 1077 O.G. 24, April 21, 1987.
Conclusion
Claim 1 remains rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to VYOMA SHAILESH THAKKER whose telephone number is (571)272-2954. The examiner can normally be reached M-F 8:30 - 5:30 EST.
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/VYOMA SHUBHAM TIWARI/Examiner, Art Unit 1634
/MARIA G LEAVITT/Supervisory Patent Examiner, Art Unit 1634