Notice of Pre-AIA or AIA Status
1. 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
2. Applicant’s election without traverse of invention Group I(b) (claim(s1, 4, 10, 13-14, 18, 20, 25, and 49, drawn to chimeric receptors, nucleic acids encoding the same, immune cells expressing the same, and related compositions and kits comprising the same, that contain the signaling molecule BAFF-R) in the reply filed on 01/14/2026 is acknowledged.
3. The election without traverse filed 01/16/2026 is acknowledged. Claims 11, 23- 24, 28, 32, 35, 38, 41, 50 and 52-53 are withdrawn as being directed to non-elected subject matter. Claim 13 is amended to adjust claim dependency. Claims 1, 4, 10, 13-14, 18, 20, 25, and 49 are pending and under examination
4. It is noted that claims 23-24, 50 and 52-53 directed to intracellular SD derived from CD29 or 4-1BB (claim 23), intracellular SD derived from CTLA-4 and PD1 (claim 24), at least 3, 4, 5, 6, 7, 8, 9, 10, 15, 20, 2, 30, 35, 40, 45, 48 or 50 different SD (claims 50, and 52-53), which are nonelected species of an intracellular signaling domain derived from a signaling molecule. Therefore, claims 23-24, 50 and 52-53 are also withdrawn from further consideration pursuant to 37 CFR 1.142(b) s being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on January 16, 2026.
Information Disclosure Statement
5. The information disclosure statements (IDS) submitted 01/14/2026 and the references cited therein have been considered, unless indicated otherwise.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
6. Claim 25 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 24 recites “one or more of the following” when describing what is comprised in the pharmaceutical composition. However, the option for “one or more of the following” is confusing and taken away when the current claims are recited “ a) a recombinant nucleic acid according to claim 14; and b) a recombinant immune cell comprising the recombinant nucleic acid of (a”. This renders the claim indefinite as it fails to particularly point out the subject matter regarding what is contained in the pharmaceutical composition.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
6. Claims 1, 4, 10, 13-14, 18, 20, 25 and 49 are rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by Juno Therapeutics, Inc (referred to as Juno hereinafter) (cited in IDS filed 01/14/2026) (WO 2017079705 A1, published 11 May 2017).
The instant claims are drawn to a chimeric receptor comprising: a) an extracellular anti-biding domain capable of binding to a target antigen; b) a transmembrane domain; and c) an intracellular signal transduction domain comprising an intracellular signaling domain (SD) derived from the signaling molecule BAFF-R.
Juno teach in claim 1, a chimeric receptor comprising a ligand binding domain, a transmembrane domain, and an intracellular signaling domain. The ligand-binding domain is an antigen binding domain (claim 20), and the signaling molecule can be BAFF-R (paragraph 125 and 126). This meets the limitation of instant claim 1
Juno teach the chimeric receptor includes an intracellular signaling domain containing an activation domain (paragraph 133 and 136). This meets the limitation of instant claim 4.
Juno teach the ligand binding domain specifically binds to an antigen such as CD24 which is an inhibitory immune checkpoint molecule or a binding moiety capable of binding to a liang of the inhibitory immune checkpoint molecule (claim 29). This meets the limitation of instant claim 10
Juno teach the extracellular portion of the chimeric receptor is derived from CD28, which is a stimulatory immune checkpoint molecule (claim 34). This meets the limitation of instant claim 13.
Juno teach a nucleic acid comprising a polynucleotide encoding the chimeric receptor of claim 1 (claim 37). This meets the limitation of instant claim 14.
Juno teach a composition, comprising an engineered cell, comprising the nucleic acid that encodes the chimeric receptor of claim 1 (claim 47). This meets the limitation of instant claim 18.
Juno teach an engineered cell, comprising the nucleic acid that encodes the chimeric receptor and comprising the chimeric receptor of claim 1. This meets the limitation of instant claim 20.
Juno teach a medicament which includes the nucleic acid and immune cell comprising the nucleic acid for treating a disease (claim 84). Juno also teach compositions containing the chimeric receptor and compositions containing the engineered cells, including pharmaceutical compositions and formulation (paragraph 235). This meets the limitations of instant claim 25.
Regarding instant claim 49, a kit is a collection of components. Juno teach kits for producing the genetically engineered cells. The genetic engineering generally involves introduction of a nucleic acid encoding the chimeric receptor into a composition containing the cultured cells, such as by retroviral transduction, transfection, or transformation which are the only components recited in the kit (paragraph 170). Juno further teaches methods for engineering, preparing, and producing the cells, compositions containing the cells, and kits and devices containing and for using, producing and administering the cells (paragraph 83). Therefore, the prior art fulfills the limitations of the kit comprising the chimeric receptor by teaching the components of the kit. See In re Venezia 189 USPQ 49 (CCPA 1976), where kits are drawn to the structural attributes of interrelated component parts and not to activities that may or may not occur.
Conclusion
X. No claims are allowed.
X. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Syed J Abbas whose telephone number is (571)272-0015. The examiner can normally be reached M-Th, 9:00AM-4:00PM.
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/SYED J ABBAS/Examiner, Art Unit 1674
/VANESSA L. FORD/Supervisory Patent Examiner, Art Unit 1674
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