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 .
Detailed Action
Note: The filing receipt of August 16, 2023, is being used for the priority data as claimed by Applicant.
The election with traverse filed April 5, 2026, is acknowledged and has been entered. Applicant has elected Group I. Applicant has elected with traverse the species of a single tumor antigen of interest, wherein the tumor antigen is GD2.
The traversal is on the basis that it would not impose an undue burden on the Examiner to search and examine Groups I and II together because any search for the modified T cell of Group I, would be a search of a method of using as in Group II. With respect to the species requirement, Applicant argues that as discussed in “Applicants respectfully assert that the present genus of three (3) modified T cell cargos; three (3) types of antigen of interest; and ninety-four (94) tumor antigens represents a finite number of species and thus Applicants should not be required in the present application to elect a species when applicants have not claimed an unreasonable number of species”.
In response, art identified in a search for the modified T cell of Group I, would not necessarily be applicable be applicable to the method of Group II as the art may disclose the modified T cell for other purposes. Furthermore, a serious search burden is established when the groups require different search strategies/queries as is the case here because searching for the product requires a different search than the search required by the method.
Then with respect to the 94 tumor antigens (and other bacterial and viral antigens, etc), each has a distinct structure and also searching each different antigen would require different search strategies/queries such that there would be a serious search burden to consider each different species.
Therefore, the requirement is still deemed proper and is made FINAL.
Claims 1-3, 5, 7-8, 11-14, 16, 18-20, 22-24 and 29-30 are pending. Claims 5, 7-8, 13-14, 16, 18-20, 22-24 and 29-30 are withdrawn from further consideration, as being drawn to non-elected invention or species of invention. Claims 1-3 and 11-12 are under consideration.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103(a) are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-3 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2017/192924 A1 (Riddell et al) and WO 2015/188119 A1 (Freidman, Kevin).
Relevant to claims 1-3, Riddell et al discloses compositions comprising T cells comprising a vector encoding a tumor antigen and one or more exogenous immunogenicity enhancer and combining such compositions with additional therapeutic agents such as immune cells expressing engineered T Cell receptors (see entire document, e.g., pages 7-8, 13, 23-25, 36 and 52).
Relevant to claims 1-3, Riddell et al discloses that the immunogenicity enhancers, includes an inducible cell death factor (see pages 33-34 and claim 15) which kills the cell and therefore, necessarily reduces transgene expression.
Relevant to claims 1-3, Freidman disclose compositions comprising Freidman disclose T cells comprising a vector encoding a engineered T Cell receptors that bind the GD2 cancer antigen (see entire document, e.g., pages 2 and 41) and that T cells can be subject to stimulation and/or activation with costimulatory ligands such as the target antigen that binds the engineered TCR (see pages 28-29).
Relevant to claim 11, Freidman disclose that the vector can use an inducible promoter (see pages 60-62).
Accordingly, it would have been prima facie obvious to one of ordinary skill in the art at the time the claimed invention was made to make T cells comprising a vector encoding a tumor antigens comprising the GD2 antigen and an engineered T Cell receptor (TCR) that binds the antigen because such a T cell would express the antigen as a vaccine to stimulate an immune response as well as the additional therapeutic agent TCR for adoptive T cell immunotherapy as disclosed by both references. Such T cells would have the advantage of comprising both therapeutic modalities in one population of T cells, so that separate treatments would not need to be made or delivered to enhance the antitumor immune response. Furthermore, T cell expressing tumor antigen vaccines and T cell expressing engineered TCRs were both useful to treat cancer and, "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." See logic of In re Kerkhoven, 626 F.2d 848, 850, 205 USPQ 1069, 1072, (CCPA 1980) and MPEP § 2144.06. Therefore, when targeting GD2 expressing cancer, one would have been motivated to include both an engineered TCR that binds GD2 antigens and GD2 antigens in the same T cells to enhance the antitumor response. Then as inducible promoters were known and commonly used in expressing exogenous proteins in T cells, using an inducible promoter as taught by Freidman would be seen as combining prior art elements according to known methods to yield predictable results. Finally, including an inducible knockout system (such as an inducible cell death factor) would have the advantage of enhancing immunity of the composition and also could be used to eliminate the T cells if necessary or desirable.
Accordingly, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the reference, especially in the absence of evidence to the contrary.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Brad Duffy whose telephone number is (571) 272-9935. The examiner can normally be reached on Monday through Friday.
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Julie Wu can be reached on (571) 272-5205. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Respectfully,
Brad Duffy
571-272-9935
/Brad Duffy/
Primary Examiner, Art Unit 1643
June 12, 2026
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