DETAILED ACTION
Applicants claim amendments in the response filed 3/19/2026 are acknowledged and entered into the record.
Accordingly, Claims 1, 4, 5, and 7 are pending and will be examined on the merits.
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
New Grounds of Rejection
(based on reconsideration)
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.
Claim(s) 1, 4, 5, 7 are rejected under 35 U.S.C. 103 as being unpatentable over Mooney et al. (PgPub 2019/0216910) in view of Tareen et al. (WO2017068419)
The claims are drawn to a hydrogel matrix comprising a viral vector encoding a chimeric antigen receptor, an NK cell receptor, an NK T cell receptor, and/or a T cell receptor and one or more chemoattractants, wherein the chemoattractants attract and retain an immune cell to the hydrogel. The claims are further drawn to wherein the hydrogel matrix further comprises one or more antibodies, cytokine and/or co-stimulatory molecules and a chemotherapeutic agent or immune blockade inhibitor.
Mooney et al. teach a scaffold composition and any one of, or any combination of (e.g., in or on the scaffold composition), the following: (a) at least one antigen; (b) at least one immunostimulatory compound; (c) at least one compound that attracts an immune cell to or into the delivery vehicle; (d) at least one compound that induces immunogenic cell death of a tumor cell; (e) at least one compound that inhibits T-cell or dendritic cell suppression; and/or (f) at least one compound that inhibits an immune-inhibitory protein.. Mooney et al. further discloses the scaffold composition (i) comprises open interconnected macropores; or (ii) is a pore-forming scaffold composition. In some embodiments, the scaffold composition comprises a hydrogel or a cryogel. Mooney et al. disclose the device/scaffold further comprises a mRNA or expression vector encoding a cytokine. In some embodiments, the cytokine is granulocyte macrophage colony-stimulating factor (GM-CSF), FMS-like tyrosine kinase 3 ligand (Flt3L), Chemokine (C-C Motif) Ligand 20 (CCL20), Interleukin 15 (IL-15), Chemokine (C Motif) Ligand 1 (XCL1), Chemokine (C-X-C Motif) Ligand 10 (CXCL10), Interferon Alpha 1 (IFN-alpha), Interferon Beta (IFN-beta), or Interleukin 12 (IL-12) (see paragraph [59]). Mooney et al. discloses an mRNA molecule or expression vector encodes the cytokine described herein, and the expression vectors are typically viruses or plasmids (see paragraphs [59] and [365]). Mooney et al. does not explicitly disclose a hydrogel scaffold comprising a viral vector encoding a chimeric antigen receptor (CAR), an NK cell receptor, an NK T cell receptor, and/or a T cell receptor. This deficiency is made up for by Tareen et al.
Tareen et al. teach transduction methods using oligomeric protein reagent compositions that facilitate the transduction process (See paragraphs 0003 and 0160). The oligomeric protein reagent can be a multimerization reagent bearing a plurality of binding agents for viruses and/or target cells (See paragraph 0160). The viral particles and oligomeric reagent can be mixed prior to contacting with cells, or the cells can be contacted with the oligomeric reagent and viral particles simultaneously or separately (See paragraph 0163). The oligomeric reagent can be immobilized on a support for transduction (See paragraphs 0185, 0228, and 0357). The solid support can be a matrix, such as agarose particles or a crosslinked gel, a bead (See paragraphs 0228-0229). The crosslinked gel may be based on a hydrophilic polymer (which reads on “hydrogel”) (See paragraph 0237). The cells can be isolated immune cells, such as T cells or NK cells, or stem cells, such as iPSC (See paragraphs 0285 and 0370-0372). The T cell can be naïve (See paragraphs 0049, 0361, 0371, and 0418). The viral vector can comprise a heterologous nucleic acid encoding a CAR (See paragraphs 0068, 0104, and 0337). The cell-binding agents can be stimulatory agents such as antibodies or cytokines (See paragraphs 0037 and 0111). The stimulatory agents can be antibodies against CD3, CD28, 4-1BB, ICOS, IL-2, and/or IL-15 (See paragraphs 0053, 0181, and 0414). The composition may also contain more than one active ingredients such as chemotherapeutic agents (see paragraph 0511). The cells can be activated by stimulatory agents present on the surface of a solid support (See paragraph 0053).
It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to combine the teachings of Mooney et al. and Tareen et al. to arrive at a hydrogel scaffold or matrix comprising all the elements of the instant claims. Mooney et al. teach the device (scaffold) comprises a viral genome encoding a polypeptide on the surface of immune cells and therefore would include the CAR, NK or T cell receptors taught by Tareen et al., both of which are taught to be comprised within the scaffold or matrix disclosed by the prior art. Combining prior art elements according to known methods to yield predictable results is considered to be prima facie obvious (see MPEP 2143(I)).
Response to Arguments
Applicant's arguments filed 3/19/2026 have been fully considered. Applicants correctly point out that Mooney et al. does not explicitly teach a viral vector encoding a CAR, NK cell receptor, NK T cell receptor or a T cell receptor. This deficiency is remedied by the new 103 rejection set forth above. Applicants further argue Mooney et al. does not teach the claimed elements of instant Claim 7 “further comprising a chemotherapeutic agent, however Mooney et al. does in fact teach the device further comprises a chemotherapeutic agent (see paragraph [51]).
All other rejections are hereby withdrawn in view of applicants arguments in the response
filed 3/19/2026
Conclusion
Claims 1, 4, 5, 7 are rejected.
No Claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MEERA NATARAJAN whose telephone number is (571)270-3058. The examiner can normally be reached M-F 9AM - 5PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, JULIE WU can be reached at 571-272-5205. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/Meera Natarajan/Primary Examiner, Art Unit 1643
Prosecution Insights