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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 12/23/25 has been entered.
Applicant has amended claim 1 substantially to now read:
Claim 1. A composition comprising a population of induced pluripotent stem (iPS) cell cells, comprising: a T cell receptor (TCR) specific for a first antigen expressed on a target cell or a nucleic acid encoding the TCR; and a chimeric antigen receptor (CAR) specific for a second antigen expressed on the target cell or a nucleic acid encoding the CAR, wherein the iPS cells were derived from a cytotoxic T cell that is specific for the first antigen, and wherein the TCR and the CAR target two antigens comprising the first antigen and the second antigen, respectively.
Applicant's arguments have been fully considered and the amendment and arguments are sufficient to overcome the anticipation rejection.
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.
Claims 1-3, 9 & 18-27 (new claims) are rejected under 35 U.S.C. 103 as being unpatentable over Yano et al (The Japanese Journal of Clinical Hematology 2018 AV from IDS).
Yano discloses selecting an antigen-specific CTL for a viral antigen or the like, reprogramming the same to create iPS cells (T-iPS cells), and inducing differentiation thereof to obtain cells (T-iPS-T cells) that have a high level of division potential while having the same TCR reconstruction as the CTL, as well as applying these features to tumor surface antigens and indicates that T cells comprising introduced CAR genes. Redifferentiation into CAR-T-iPS-T cells can be induced by introducing a CAR gene into T cell-derived iPS cells (p. 226, right column, line 3, to p. 229, left column, line 24).
While not anticipating, the newly amended claims, within the confines of the single reference, Yano does teach both methodologies and teaches introducing CAR to a population of iPSCs and the ‘a cloned cytotoxic T cell specific for the first antigen expressed on the target cell” is a disclosed population in Yano. That given, the teachings with Yano are strongly suggestive of the claimed invention.
Applicant is directed to pages 12-13 of KSR v Teleflex (500 US 398 2007) “ … the Court has held that a “patent for a combination which only unites old elements with no change intheir respective functions . . . obviously withdraws what is already known into the field of its monopoly and diminishes the resources available to skillful men.” Great Atlantic & Pacific Tea Co. v. Supermarket Equipment Corp., 340 U. S. 147, 152 (1950). This is a principal reason for declining to allow patents for what is obvious. The combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results.” “When a work is available in one field of endeavor, design incentives and other market forces can prompt variations of it, either in the same field or a different one(emphasis added). If a person of ordinary skill can implement a predictable variation, §103 likely bars its patentability. For the same reason, if a technique has been used to improve one device, and a person of ordinary skill in the art would recognize that it would improve similar devices in the same way, using the technique is obvious unless its actual application is beyond his or her skill.” The Yano reference would have been obviously modified using any known target antigen such as LMP1 or LMP2 as the methods and means for doing so are old and well known in the art.
"[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%.); >see also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 ("The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.");< ** In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969) (Claimed elastomeric polyurethanes which fell within the broad scope of the references were held to be unpatentable thereover because, among other reasons, there was no evidence of the criticality of the claimed ranges of molecular weight or molar proportions.). For more recent cases applying this principle, see Merck & Co. Inc. v. Biocraft Laboratories Inc., 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.), cert. denied, 493 U.S. 975 (1989); In re Kulling, 897 F.2d 1147, 14 USPQ2d 1056 (Fed. Cir. 1990); and In re Geisler, 116 F.3d 1465, 43 USPQ2d 1362 (Fed. Cir. 1997).
Accordingly, the claimed invention was prima facie obvious to one of ordinary
skill in the art at the time the invention was made especially in the absence of evidence
to the contrary.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BLAINE LANKFORD whose telephone number is (571)272-0917. The examiner can normally be reached M-Th 8-6:30.
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BLAINE LANKFORD
Examiner
Art Unit 1657
/BLAINE LANKFORD/ Primary Examiner, Art Unit 1657