Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
DETAILED ACTION
Status of Application, Amendments, and/or Claims
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 06/10/2026 has been entered.
Claims 103, 106-126, and 129-132 are pending and currently under consideration.
Claim Rejections under 35 USC § 112 (a)
(i). The following is a quotation of the first paragraph of 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.
(ii). Claims 103, 106-126, and 129-132 are rejected under 35 U.S.C. 112(a), 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 at the time the application was filed, had possession of the claimed invention. The basis for the rejection is set forth in the office action mailed on 06/23/2025.
(iii). Response to Applicant’s argument
Applicants argues that single domain antibodies are described in the specification of the instant application. Applicant argues that recent case law clearly supports the patentability of method claims based on the claimed use, not based on the genus of antibodies or the antibody variable domain. Applicant notes that in Teva Pharmaceuticals Int'l GmbH v. Eli Lilly & Co. (Fed Cir. 2026) the Federal Circuit upheld broad method-of-treatment claims reciting administering "an anti-CGRP antagonist antibody" to treat headache, even though the claims covered any antibody satisfying that functional requirement. Applicant notes that for method claims, the court held that the written description and enablement inquiries under 35 U.S.C. § 112 focus on the claimed use-not the genus of antibodies themselves.
Applicant argues that these requirements are satisfied for the instant claims because the cytotoxic mutant serine protease as instantly claimed is attached to a well-known genus of single domain antibodies that are available and/or can be generated by routine techniques. Applicant argues that Applicants have fully described this new cytotoxic payload, which can be expressed as a fusion protein with an antibody (e.g., an scFv or a single domain antibody) as instantly claimed, and the instant claims are directed towards a method of treating cancer. Applicant notes that Teva Pharmaceuticals Int'l GmbH v. Eli Lilly & Co. applies and shows that the instant method-of-treatment claims can validly recite a functional genus of antibodies since single domain antibodies that selectively bind cancer cells are well-known in the art.
Applicant’s argument has been fully considered but is not deemed to be persuasive. The fact pattern in the instant case is different from that in Teva Pharmaceuticals Int'l GmbH v. Eli Lilly & Co. (Fed Cir. 2026). In Teva Pharmaceuticals v. Eli Lilly & Co. (Appeal No. 24-1094), the claim methods of treating headaches in a human comprising administering to the human an effective amount of an anti-CGP antagonist antibody, wherein said anti-CGRP antagonist antibody is a humanized monoclonal antibody. The specification explains that anti-CGP antagonist antibodies were known in the art and discloses one humanized anti-CGRP antagonist antibody as well as various murine anti-CGRP antagonist antibodies. In contrast, claim 103, for example, of the instant application is drawn to a method of treating a subject with a cell proliferative disease comprising administering to the subject an effective amount of a cell-targeting polypeptide construct comprising, from N-to C-terminus: (a) a truncated serine protease …; and (b) a cell-targeting single domain antibody, wherein the cell-targeting single domain antibody can bind the cancer.
First, claim 103 of the instant application does not require that single domain antibody binds a particular antigen in a cancer cell. In other words, the antigen that the single domain antibody binds is undefined, and claim 103 recites an enormous genus of single domain antibodies without any structural/functional features or defined antigen targets. In the case of In Teva Pharmaceuticals v. Eli Lilly & Co. (Appeal No. 24-1094), the antibody is a humanized anti-CGP antagonist antibody, and the antigen that the antibody binds is clearly defined. Second, in the instant case, the specification does not disclose a single cell-targeting single domain antibody or a cell-targeting polypeptide comprising a cell-targeting single domain antibody. In the case of In Teva Pharmaceuticals v. Eli Lilly & Co. (Appeal No. 24-1094), the specification discloses one humanized anti-CGRP antagonist antibody as well as various murine anti-CGRP antagonist antibodies. Third, there is no evidence on the record, neither in the specification nor in Applicant’s response, showing that single domain antibodies that selectively bind cancer cells are well-known in the art. As an additional note, Applicant argues about a limitation not present in claim 103: single domain antibodies that selectively bind cancer cells. In contrast, in the case of In Teva Pharmaceuticals v. Eli Lilly & Co. (Appeal No. 24-1094), humanized anti-CGRP antagonist antibody is well-known in the art as disclosed in the specification. Therefore, the instant disclosure does not adequately support the genus of cell-targeting polypeptides and thus the method of using the same.
Conclusion
No claims are allowed.
Advisory Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Ruixiang Li whose telephone number is (571) 272-0875. The examiner can normally be reached on Monday through Friday from 8:30 am to 5:00 pm. 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 number for the organization where this application or proceeding is assigned is (571) 273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, please contact the Electronic Business Center (EBC) at the toll-free phone number 866-217-9197.
/RUIXIANG LI/Primary Examiner, Art Unit 1674 June 13, 2026
Prosecution Insights