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
Applicant's amendment filed on 11/19/2025 has been entered. Claims 104-105 and 127-128 are canceled. New claim 132 is added. Claims 103, 106-126, and 129-132 are pending and currently under consideration.
Withdrawn Objections and/or Rejections
The rejection of claims 103-131 under 35 U.S.C.112 (b) is withdrawn in view of amended claims 103 and 130.
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.
Applicants argues that the instant pending claims specify delivery of cell-targeting polypeptide constructs that comprise a cytotoxic truncated serine protease as instantly claimed and a single domain antibody that can selectively bind an antigen on the cancer. Applicant argues that a variety of antigenic polypeptide targets are expressed on cancer cells that are well-known to one of skill in the art and an appropriate single domain antibody could be selected to bind the antigen on the cancer cell.
Applicant’s argument has been fully considered but is not deemed to be persuasive. Claim 103 is drawn to a method of treating a subject with cancer comprising administering to the subject an effective amount of a cell-targeting polypeptide comprising a truncated serine protease, and a cell-targeting single domain antibody. The claim does not require that the cell-targeting single domain antibody possess any particular conserved structural features or binding activities; the claim does not require that the cell-targeting polypeptide possess any particular functional features. Claims 106-126, and 129-132 depend from claim 103. The claims encompass a genus of cell-targeting polypeptides without defined structural/functional features for the cell-targeting single domain antibody.
For each claim drawn to a genus, MPEP §2163 II.A.3(a) ii) (page 2100-189) states, “The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice (see i)(A), above), reduction to drawings (see i)(B), above), or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus (see i)(C), above). See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406”. 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. Furthermore, the prior art does not provide compensatory structural or correlative teachings sufficient to enable one of skill to identify
a cell-targeting polypeptide comprising a cell-targeting single domain that can be used to treat cancer in a subject. Thus, 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
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 extension fee 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 date of this final action.
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.
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/RUIXIANG LI/Primary Examiner, Art Unit 1646 December 9, 2025