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 .
Election/Restrictions
Applicant’s election without traverse of Group I and species comprising heavy chain CDR1-3 of SEQ ID NO:74-76 and light chain CDR1-3 of SEQ ID NO:78-80, respectively, in the reply filed on 09/30/2025 is acknowledged.
Claims 5 and 9 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected inventions, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 09/30/2025.
Specification
The use of the term Corning, Tween ([0033], lines 1 and 3) and Promega ([0036], second to last line), which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Applicant is encouraged to review the specification for other trade names or marks.
Drawings
The drawings are objected to because the drawings are not numbered. In accordance 37 C.F.R. 1.84 (u) Numbering of views:
(1) The different views must be numbered in consecutive Arabic numerals, starting with 1, independent of the numbering of the sheets and, if possible, in the order in which they appear on the drawing sheet(s). Partial views intended to form one complete view, on one or several sheets, must be identified by the same number followed by a capital letter. View numbers must be preceded by the abbreviation "FIG." Where only a single view is used in an application to illustrate the claimed invention, it must not be numbered and the abbreviation "FIG." must not appear.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Rejections - 35 USC § 112(a)
Claims 6 and 8 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 a method of blocking binding of GITR-L to GITR, activating T lymphocytes, or increasing expression of IL-2 and/or IFN-γ in T lymphocytes, comprising contacting T lymphocytes with (for claim 6) the anti-GITR monoclonal antibody or the antigen-binding fragment thereof according to claim 1 or (for claim 8) the anti-GITR monoclonal antibody conjugate of claim 7, does not reasonably provide enablement for increasing expression of IL-2 in T lymphocytes which are regulatory T cells or wherein the T lymphocytes are not contacted with the anti-GITR monoclonal antibody, antigen-binding fragment thereof or antibody conjugate thereof. 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 a method of blocking binding of GITR-L to GITR, activating T lymphocytes, or increasing expression of IL-2 and/or IFN-γ in T lymphocytes using (for claim 6) the anti-GITR monoclonal antibody or the antigen-binding fragment thereof according to claim 1 or (for claim 8) the anti-GITR monoclonal antibody conjugate of claim 7. There are two enablement issues for these claims.
First, the claims have great breadth due to the term “using”, while the specification discloses the anti-GITR antibody must contact the T lymphocytes in order to accomplish the activities of the method. The T lymphocytes express GITR and it is only by the antibody binding its cognate antigen that activation through GITR occurs and the recited activities of the method can be accomplished. This is illustrated by Tian et al. (Front. Immunol. 11:588682, 7 pages, Oct. 2020, Fig. 1) illustrates that activation of GITR on the surface of T cells occurs by binding of GITRL or an anti-GITR antibody to the GITR. The examples in the specification showing the claimed results of the method used in vitro CD4+ T cells or Jurkat T cells contacted with the anti-GITR antibody (Examples 4-6). The specification has not provided direction or guidance wherein T lymphocytes are not contacted by the anti-GITR antibody, antigen-binding fragment or conjugate thereof nor would the skilled artisan reasonably expect the recited activities to occur in the absence of direct contact of the T lymphocytes by the antibody or antigen-binding fragment thereof.
Second, the claims recite that there can be an increase in IL-2 and IFN- γ. There are several distinct types of T lymphocytes, including CD4+ (helper) T cells, CD8+ (cytotoxic) T cells, regulatory T cells (Tregs) and memory cells. All T lymphocytes have been shown to produce IFN-γ (e.g., Whitmire et al., J. Exp. Med. 201(7):1053-159, 2005, p. 1053, col. 1, first sentence, and de Araújo-Souza et al., J. Leukoc. Biol. 108:1329–1337, 2020, p. 1330, col. 1, second paragraph), but Tregs do not produce IL-2 (see Tian et al., ibid.). Therefore, the claims are not enabled for their full scope in terms of IL-2 production in T lymphocytes. As discussed above, the specification used only CD4+ T cells and Jurkat cells, which are derived from a T cell leukemia, and IL-2 and IFN- γ production was assayed in separate experiments.
For the reasons discussed above and including the breadth of the term “using” and subtypes of T lymphocytes encompassed, limited working examples, the lack of guidance or direction for performing the method wherein the T lymphocytes are not contacted by the antibody, antigen-binding fragment thereof or antibody conjugate, the showings in the prior art supporting the effect of a GITR-binding antibody on only GITR-expressing T lymphocytes and for IL-2 production by T lymphocytes which are not Tregs, and the complexity of immune cells and activation thereof, it would require undue experimentation to practice the method commensurate in scope with the claims.
Examiner Comment
The following claim is drafted by the examiner and presented to applicant for consideration:
Claim 6. A method of blocking binding of GITR-L to GITR, activating T lymphocytes, or increasing expression of IL-2 and/or IFN-γ in T lymphocytes, comprising contacting T lymphocytes with .
Allowable Subject Matter
Claims 1-4 and 7 are allowed.
The following is a statement of reasons for the indication of allowable subject matter: The anti-GITR monoclonal antibody and antigen-binding fragment thereof having heavy and light chain variable region CDR sequences SEQ ID NO:74, 75, 76, 78, 79, and 80, respectively, are free of the prior art. While the prior art discloses anti-GITR monoclonal antibodies (see foreign patent documents cited in the IDS filed 12/28/2022, for example), these do not meet the structural limitations of instant claims.
Prior Art
The prior art made of record and not relied upon is considered pertinent to Applicant's disclosure.
US 20220119541 A1 teaches antibodies that bind GITR, including a clone called 4B11 (Table 1). However, none of the anti-GITR antibodies disclosed therein have the same heavy and light chain CDR sequences as those of the instant claims, which also belong to a clone called 4B11 (instant Tables 1 and 2).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Claire Kaufman, whose telephone number is (571) 272-0873. Examiner Kaufman can generally be reached Monday through Friday 7am-3:30pm, Eastern Time.
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Vanessa Ford, can be reached at (571) 272-0857.
Any inquiry of a general nature or relating to the status of this application should be directed to the Group receptionist whose telephone number is (571) 272-1600.
Official papers filed by fax should be directed to (571) 273-8300. NOTE: If applicant does submit a paper by fax, the original signed copy should be retained by the applicant or applicant's representative. NO DUPLICATE COPIES SHOULD BE SUBMITTED so as to avoid the processing of duplicate papers in the Office.
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Claire Kaufman
/Claire Kaufman/
Primary Examiner, Art Unit 1674
January 8, 2026