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 .
Claims 1-53 have been cancelled. Claims 54-73 have been newly introduced.
Specification
The disclosure is objected to because of the following informalities:
The description of the drawings does not include the subparts of Figure 38A, 38B-1, 38B-2, 38C-1, 38C-2, 38C-3, 38C-4, and 38C-5 and the subparts of Figure 40A, 40A-1, and 40B.
Appropriate correction is required.
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 54-73 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.
Claims 54-73 are not original claims. They were added by amendment on 11/5/2024. Basis was stated to be in the original claims and throughout the specification. No specific basis was pointed to and none is apparent.
Independent claims 54 and 73 recite that the IL12 p40 moiety comprises a D2 and D3 domain and “does not comprise a p40 D1 domain.” None of original claims 1-53 contain this limitation.
Specification paragraph [0242] discloses that in some embodiments, the p40 moiety comprises p40 D2 and D3 domains, to the exclusion of the p40 D1 domain. See also Figures 3G-3I. SEQ ID NOS: 92 and 93 in Table 8B at page 215 disclose specific constructs that lack the p40 D1 domain. However, there is no general disclosure having the limitation of excluding the p40 D1 domain in the context of the limitations of new claims 54-73. In particular, these portions of the specification do not disclose the structure or identity of any second polypeptide chain with a first polypeptide as recited in instant claims 54 and 73. Independent claims 54 and 73 and dependent claims 55, 63, and 71-72 do not provide an N- to C-terminal order for each of the listed components. Finally, the p40 D2 domain and p40 D3 domain are not required to be in any particular order.
The claims constitute new matter. Applicant should point by page and line number for specific basis for each of these claims.
Claims 54-73 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, to make and/or use the invention.
The claimed products and methods are not enabled. Mutein 12 (SEQ ID NO: 92) and mutein 13 (SEQ ID NO: 93) are the only exemplified embodiments of constructs meeting the limitations of the claims. They had no ability to induce luciferase activity in the CTLL2/Stat3-Luc assay. See at least Figure 20A. No other measures of biological activity appear to have been tested for constructs lacking the p40 D1 domain. No biological activity has been shown for these constructs.
It is not known how to use the claimed IL-12 receptor agonists when no agonist activity has been shown. See in particular the methods of claims 72-73.
The claims are not enabled.
The art of record and not relied upon is considered pertinent to applicant's disclosure.
Fu et al. (WO 2019/209965, of record), Lu et al. (WO 2021/062406, of record), Hedvat et al. (WO 2021/067863, of record), and Garcia et al. (WO 2021/212083, of record) do not disclose or suggest excluding the D1 domain of IL-12 p40.
Chang et al. (U.S. Patent No. 12,522,638) issued from U.S. Application 17/813,122 and corresponds to U.S. Patent Application Publication 2023/0051304. These documents are not prior art against the instant claims as they have the same inventors and applicant as the instant application and have the same effective filing date. They claim priority to the same provisional applications. The claims of the ‘638 patent differ from the instant claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARIANNE P ALLEN whose telephone number is (571)272-0712. The examiner can normally be reached 7:00-3:30 EST Monday-Friday.
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/Marianne P Allen/Primary Examiner, Art Unit 1647
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