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
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 June 16, 2025, has been entered.
Applicant’s amendment filed June 16, 2025, is acknowledged and has been entered. Claims 4, 13, and 16have been amended. Claims 2 and 17 have been canceled. Claim 60 has been newly added. The sequence of SEQ ID NO:4 has been corrected. The correction of SEQ ID NO:4 has placed claim 1 in condition for allowance. Therefore, claims 3 and 7 have been rejoined.
Claims 1, 3-10, 13-16, 18-23, 25-31 and 52-58 are pending.
Claims 25-31 and 52-58 have been withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a non-elected invention, there being no allowable generic or linking claim.
Claims 1, 3-10, 13-16 and 18-23 are under examination. The elected invention is Group I.
Grounds of Rejection Withdrawn
Unless specifically reiterated below, Applicant’s amendments have obviated or rendered moot the grounds of rejection set forth in the previous Office action mailed.
Claim Rejections Maintained
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.
Claims 19-23 are rejected under 35 U.S.C. 103 as being unpatentable over Jones et al (WO 2017/123956 A1) and Kiefer et al (B, 37:991-997, 1998).
Jones et al disclose nucleic acids encoding a chimeric antigen receptor that comprises a melanocortin receptor binding domain (target antigen is the tumor antigen MC1R), a CD8 alpha hinge and transmembrane domain, a 4-1BB costimulatory domain and a CD3 zeta signaling domain, wherein the binding domain is an antibody that binds the target antigen or a ligand that bind its cognate receptor the nucleic acid in vectors, T cells and compositions comprising the cells (see pages 2, 14-25).
Kiefer et al disclose that mouse and human agouti are peptide ligands that bind to melanocortin receptors (see pages 991, 995 and 996, in particular paragraph spanning 995 and 996).
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 include a human agouti peptide ligand that binds MCR in the chimeric antigen receptors and nucleic acids in modified T cells of Jones et al because Jones et al states that a ligand that binds its cognate receptor can be used as a binding domain in a CAR, while Kiefer et al disclose that a human agouti peptide ligand would bind to human melanocortin receptors, including MCR on melanoma tumor cells. In this case, making such products would be considered combining prior art elements according to known methods to yield predictable results. Finally, one of skill in the art would have had a reasonable expectation of success in making such products because the prior art evidences that genetic engineering techniques to fuse such domains into recombinant CARs that can be expressed in modified T cells were known in the art.
Therefore, 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 references.
In the response, Applicant traverses the rejection and submits that the correction of the typographical error in SEQ ID NO:4 has obviated the rejection.
In response, this argument is not found persuasive because claims 19-23 do not require a mutant MC1R binding domain comprising the amino acid sequence of SEQ ID NO: 4. Claim 19 recites “[a] modified cell comprising a nucleic acid sequence encoding a chimeric antigen receptor (CAR) comprising a melanocortin receptor (MCR) binding domain, a transmembrane domain, a costimulatory signaling region, and a signaling domain, wherein the MCR binding domain comprises a MCR peptide ligand or fragment thereof”.
Accordingly, after careful and complete consideration of Applicant’s response and the record as a whole, for these reasons and the reasons set forth in the previous office action, this rejection is being maintained.
New Claim Rejections
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 3 and 7 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. In this case, claims 3 and 7 depends from claim 1 and claim 1 recites an isolated nucleic acid sequence encoding a chimeric antigen receptor (CAR) comprising a melanocortin receptor (MCR) binding domain, a transmembrane domain, a costimulatory signaling region, and a signaling domain, wherein the MCR binding domain comprises the amino acid sequence set forth in SEQ ID NO: 4, while claims 3 and 7 do not encode an MCR binding domain comprising the amino acid sequence set forth in SEQ ID NO: 4 or a CAR comprising an MCR binding domain comprising the amino acid sequence set forth in SEQ ID NO: 4. As such claims 3 and 7 failsto include all the limitations of the claim upon which it depends.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Conclusion
Claim 1, 4-6, 8-10, 13-16 and 18 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 Mon-Fri.
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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.
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Respectfully,
Brad Duffy
571-272-9935
/Brad Duffy/
Primary Examiner, Art Unit 1643
March 24, 2026
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