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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 06/26/2026 has been entered.
Status of Claims
Claims 1, 6, and 10-16 are pending and under examination.
WITHDRAWN REJECTIONS
Claim Rejections - 35 USC § 103
Claims 1, 4-5, and 10-13 are rejected under 35 U.S.C. 103 as being unpatentable over Benedetti et al ( EMBO Mol Med. 2018 Feb; hereinafter "Benedetti;" See PTO-892) in view of Ban et al (Proc Natl Acad Sci U S A. 2011 Aug 23; hereinafter "Ban;" See IDS of 5/4/2023).
Claims 1, 6, and 14-16 are rejected under 35 U.S.C. 103 as being unpatentable over Gong et al ( J Biomed Sci; Published 2011; hereinafter "Gong;" See PTO-892) in view of Ban et al (Proc Natl Acad Sci U S A. 2011 Aug 23; hereinafter "Ban;" See IDS of 5/4/2023).
The rejections are withdrawn following claim amendments.
NEW REJECTIONS
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(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.
Claims 1, 6, and 10-16 are 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.
The claim(s) 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.
The claims broadly encompass a method comprising introducing an immortalization gene into a mammalian cell using a Sendai virus vector and culturing the cell at about 33°C to 35°C, wherein the cell exhibits prolonged proliferation (e.g., greater than 130 days). The claims are not limited to any particular Sendai virus vector, such as a temperature-sensitive Sendai virus, or to any specific Sendai virus mutant.
The written description, however, does not reasonably convey to one of ordinary skill in the art that the inventors were in possession of the full scope of the claimed genus as of the filing date.
The specification consistently describes the use of a particular temperature-sensitive Sendai virus system, including TS15ΔF (and closely related temperature-sensitive vectors), in which reduced-temperature culture is employed to maintain persistence of the vector and thereby extend expression of the introduced immortalization gene. The specification attributes the observed long-term proliferation to the prolonged expression achieved using this specific temperature-sensitive Sendai virus system under the disclosed culture conditions.
The examples likewise employ the disclosed temperature-sensitive Sendai virus vectors and demonstrate prolonged proliferation only in connection with those vectors. The examples do not evaluate other Sendai virus vectors, including conventional Sendai virus vectors or other members of the claimed genus, nor do they establish that reduced-temperature culture at 33°C to 35°C generally prolongs expression of an immortalization gene for all Sendai virus vectors such that prolonged proliferation exceeding the claimed duration would be obtained.
Accordingly, while the specification may demonstrate possession of the disclosed temperature-sensitive Sendai virus embodiments, it does not reasonably convey possession of the broader genus now claimed, namely the use of any Sendai virus vector cultured at about 33°C to 35°C to achieve the claimed prolonged proliferation phenotype.
Because the specification does not provide an adequate written description supporting the full scope of the claimed Sendai virus genus, the claims fail to satisfy the written description requirement of 35 U.S.C. § 112(a).
Claims 6, 10-16 inherit the rejection due to their dependency on the rejected claim.
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.
Claims 1, 6, and 10-16 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as failing to set forth 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.
Regarding claim 1: Applicant’s claim requires producing “a cell population capable of proliferating for more than 130 days after gene introduction.” It is unclear from the wording of the claim as to whether the cell is a differentiated cell that forms a tissue or a somatic stem cell or a cell that is capable of forming a tissue or somatic cell.
It is also unclear if the immortalized cell is a differentiated cell that is capable of forming (dedifferentiated) a stem cell. Appropriate clarification is required. Claims 6, and 10-16 are rejected for their dependency on the rejected claim.
Conclusion
No claims are allowed.
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/JAGAMYA NMN VIJAYARAGHAVAN/ Examiner, Art Unit 1633
/EVELYN Y PYLA/ Primary Examiner, Art Unit 1633
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