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 .
Amendment filed April 14, 2026 is entered.
Claims 38-46, 48, 50, 58, 63-64 and new claims 65-66 are pending and examined. Claims 1-37, 47, 49, 51-57, 59-62 are canceled. Claims 38-46, 48, 50, 58, 63 are withdrawn. Claims 64-66 is examined.
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 64-66 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 enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, make and/or use the invention.
The first paragraph of § 112 requires that the patent specification enable "those skilled in the art how to make and use the full scope of the claimed invention without `undue experimentation."' Genentech, Inc. v. Novo Nordisk AIS, 108 F.3d 1361, 1365, 42 USPQ2d 1001, 1004 (Fed. Cir. 1997) (quoting In re Wright, 999 F.2d 1557, 1561, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993)); see also In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970). ("[T]he scope of the claims must bear a reasonable correlation to the scope of enablement provided by the specification to persons of ordinary skill in the art."). Whether making and using the invention would have required undue experimentation, and thus whether the disclosure is enabling is a legal conclusion based upon several underlying factual inquiries. See In re Wands, 858 F.2d 731, 735, 736-37, 8 USPQ2d 1400, 1402, 1404 (Fed. Cir. 1988). As set forth in Wands, the factors to be considered in determining whether a claimed invention is enabled throughout its scope without undue experimentation include the quantity of experimentation necessary, the amount of direction or guidance presented, the presence or absence of working examples, the nature of the invention, the state of the prior art, the relative skill of those in the art, the predictability or unpredictability of the art, and the breadth of the claims.
Likewise, in Amgen Inc. v. Chugai Pharm. Co., 927 F.2d 1200, 18 USPQ2d 1016 (Fed. Cir. 1991), the court affirmed the holding of invalidity of claims to analogs of the EPO gene under § 112 for lack of enablement where applicants had claimed every possible analog of the EPO gene but had disclosed only how to make EPO and a very few analogs. "[D]espite extensive statements in the specification concerning all analogs of the EPO gene that can be made, there is little enabling disclosure of the particular analogs and how to make them .... There may be many other genetic sequences that code for EPO-type products. Amgen has told how to make and use only a few of them and is therefore not entitled to claim all of them." Id., 927 F.2d at 1213-14, 18 USPQ2d at 1027.
Claims encompass a method of treating generic autoimmune disease in a subject in need thereof with T cell comprising nucleic acid encoding SEQ ID NO:8 of CAR claimed. However, one skilled in the art cannot treat generic autoimmune disease in a subject in need thereof with the claimed T cell. The amount of direction provided in the specification is limited to prophetic treatment method of autoimmune disease. No example is provided of any treatment of autoimmune disease with the claimed T cell. The state of the art is such that one skilled in the art have not treated autoimmune disease by administering claimed T cell (June et al., US 2015/0283178). The state of the art is such that one skilled in the art treat cancers using CAR (that bind CD19) expressed in T cell therapy (June et al., US 2015/0283178). One skilled in the art is not able to predict the outcome of treatment of generic autoimmune diseases with the claimed T cell comprising CAR. The cancer treatment in the example in the specification does not provide nexus to the treatment of generic autoimmune cancer in vivo by administration of the claimed T cell expressing CAR. The mechanism underlying each specific autoimmune disease vary from one another and no nexus has been shown between the claimed CAR and the various autoimmune diseases. Autoimmune diseases can vary from type 1 diabetes to Graves’ disease which have different etiology. The claims do not recite any specific steps of the method of administration nor does the specification example teach the specific method of administration in vivo of the claimed T cell expressing CAR to treat autoimmune disease. The June model does not provide nexus to autoimmune disese from cancer treatment. Neither the specification nor June et al. teach the nexus between the cancer treatment model and the autoimmune disease. Claims encompass treatment of autoimmune disease which is not enabled.
In view of the extent and the unpredictability of the experimentation required to practice the invention as claimed, one skilled in the art could not make the invention without undue experimentation.
Therefore, based on the above Wands analysis, a preponderance of the evidence supports a conclusion that one skilled in the art would not have been enabled to make and use the invention of claims without undue experimentation.
Applicants argue that Blat teaches CAR for treatment of ulcerative colitis (UC) and autoimmune mechanism is implicated in UC pathology. However, the UC is not predictive of all autoimmune diseases. Furthermore, Blat is specifically using CAR targeting CEA which is not predictive of claimed CAR.
Applicants argue that Veri conclude that CD32B specific mAbs are suitable from the study and treatment of allergy and autoimmune diseases. However, Veri does not explain how the claimed CAR is predictive of all generic autoimmune diseases.
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL D PAK whose telephone number is (571)272-0879. The examiner can normally be reached during flexible hours. The FAX number for the examiner is (571)273-0879.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Vanessa Ford can be reached on 571-272-0857. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHAEL D PAK/Primary Examiner, Art Unit 1674
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