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 .
Status of the claims
Claims 98-109 are pending and are examined.
Priority
This application is a continuation of the Application 16/075,323 (now U.S. Pat. No. 11,661,455) which ultimately claims priority to the provisional Application 62/291,772, filed 02/05/2016.
Specification
The instant Application is a continuation of 16/075,323. The correct list of claims for the Application 16/075,323 (list of 0//22/2021) consists of claims 1-97 (cancelled) and 98-118 (new). The correct list of claims for the instant Application cannot start from the claim 98, since the instant claim differs from the claim 98 of the 16/075,323. Applicant is required to present a new list of claims reflecting the status of continuation of the instant Application. For a compact prosecution, the rejections and/or objections would be made to the list of claims presented in the instant Application on 09/05/2023, with the express understanding that the rebuttal of the rejections should be made mentioning both the incorrect claim numbering and the corrected claim numbering.
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 98-109 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for treating PD-L1 expressing cancer cells with anti-human PD-L1 VHH/human IFN R149A chimera, does not reasonably provide enablement for treating all cancers with full-length antibody chimera. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
The claims are drawn to method for treating cancer, comprising administering to a subject in need thereof an effective amount of a chimeric protein comprising:
(a) a targeting moiety that comprises a recognition domain that recognizes and binds to programmed cell death protein 1 ligand 1 (PD-L 1 ); and
(b) a modified signaling agent, wherein the modified signaling agent is a human interferon alpha 2 (IFNα2) comprising an amino acid sequence having at least 98% identity with a sequence selected from SEQ ID NO: 179 or 180 and having one or more mutations at one or more position of amino acids 144-154, wherein the mutated human IFNα2 has reduced affinity or activity as compared to wild type human IFNα2, and the reduced affinity or activity of the mutated human IFNα2 is restorable by the targeting moiety.
The prior art is not aware of treating cancer with the constructs claimed. The specification provides guidance and working examples for in vitro treatment of MDA-MB-231 PD-L1 positive cells with an anti-human PD-L1 VHH/human IFN R149A chimera.
Cancer is the name given to a collection of related diseases characterized by cellular out of control division and spreading in the surrounding or distant tissues. Cancer can start almost anywhere in the human body, which is made up of trillions of cells. Normally, human cells grow and divide to form new cells as the body needs them. When cells grow old or become damaged, they die, and new cells take their place. When cancer develops, however, this orderly process breaks down. As cells become more and more abnormal, old or damaged cells survive when they should die, and new cells form when they are not needed. These extra cells can divide without stopping and may form growths called tumors. Many cancers form solid tumors, which are masses of tissue. Cancers of the blood, such as leukemias, generally do not form solid tumors.
Types of cancer are usually named for the organs or tissues where the cancers form. Cancers also may be described by the type of cell that formed them, such as an epithelial cell or a squamous cell. Since there are approximately 300 types of cells in the human organism, there are ~300 types of cancers possible. (See evidentiary references: https://en.wikipedia.org/wiki/List_of_cancer_types- accessed 05/22/2020;
https://www.cancer.gov/about-cancer/understanding/what-is-cancer).
Treating specific cancers with antibodies linked to other therapeutic agents is known in the art. Nevertheless, each method of treatment needs to be meticulously designed and proved efficient. Also, a special emphasis is brought about the advantages of using the smallest binding portion of an antibody for a better access to the target tissue cells and lesser adverse reactions. In this sense, the use of scFv and single domain antibodies was known in the art at the time that the invention was filed. For instance, Ahmad et al. (scFv antibody: Principles and clinical Application. Clin.& Dev. Immunol. Vol. 2012, Article ID 980250, 2012) indicates that scFv is the preferred format to intact antibodies due to its smaller size and less possibility of developing adverse immune responses (conclusion section). Also, Krah et al. (Single domain antibodies for biomedical applications. Immunopharmac. & immunotox. 38, 21-28, 2016) reviewed the state of the art in the therapeutic uses of antibodies and indicated the superiority of the single domain antibodies (either VHH or vNAR) because of their high affinity and specificity, stability, small size and better reformatting opportunities (abstract).
Given the large amount of types of cancer to be treated and the multiple obstacles in using full length antibody-therapeutic moieties chimeras a person of ordinary skill in the art would have to perform a vast amount of experimentation with unpredictable and even greatly improbable results in order to treat all types of cancers with the full-antibody chimeric construct claimed. This amount of experimentation is considered undue and thus the claimed are enabled for treating PD-L1 expressing cancer cells with anti-human PD-L1 VHH/human IFN R149A chimera.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 98-109 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims of U.S. Patent No. 11,661,455. Although the claims at issue are not identical, they are not patentably distinct from each other because, while there was a restriction in '455 (January 25, 2022), there wasn't a rejoinder following allowance of an allowable product. Because there was no rejoinder, the method of using the product in instant application (18,302,364)('364) should be a Divisional Application (DIV). The BIB data sheet indicates that '364 is a CON. A possible remedy is to amend the priority of '364 as a DIV. If not, a Terminal Disclaimer needs to be submitted in order to obviate the double patenting rejection.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ELLY GERALD STOICA whose telephone number is (571)272-9941. The examiner can normally be reached M-F 8-5 EST.
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ELLY-GERALD STOICA
Primary Examiner
Art Unit 1647
/Elly-Gerald Stoica/Primary Examiner, Art Unit 1647