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 .
Claims Status
The Amendment filed on 11Jun2026 is acknowledged in which claim(s) 16-21, 25-358 were canceled by Applicant.
Applicant’s election without traverse of Group I and the species of a chimeric polypeptide comprising one CD molecule selected from (CD28, CD3e, CD45, etc.) in the reply filed on 11Jun2026 is acknowledged. No claims are withdrawn because all claims drawn to the non-elected invention were canceled by Applicant in the Amendment filed on 11Jun2026.
Claim(s) 1-15, 22-24 is/are presented for examination on the merits.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1-4, 7-11 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 2019/0292533 A1 (hereinafter “US533”).
Regarding instant claim(s) 1-4, US532 teaches an isolated immune cell comprising an inducible cytokine receptor CAR (e.g., a chimeric polypeptide) comprising an extracellular BCMA domain, a hinge region, and a transmembrane domain [e.g., abstract, ¶ 0017, 0050, 0196, 0224, 0286, 0502; pg. 90, “16.”; figs. 37A-B]. US533 further teaches the BCMA sequence comprises SEQ ID NO: 84 [e.g., tbl. 1B], which is the same as the instant claimed SEQ ID NO: 19 (see alignment below).
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305
451
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Alignment of instant extracellular domain (SEQ ID NO: 19) with US533 BCMA (SEQ ID NO: 84):
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157
719
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Regarding instant claim(s) 7-11, US533 further teaches the CARs comprises a CD8a (e.g., a CD8 alpha chain) hinge and transmembrane domain of SEQ ID NO: 182 (e.g., one sequence with hinge, transmembrane, and LYC motif) [e.g., ¶ 0286], wherein the transmembrane domain is the same as instant claimed SEQ ID NO: 26 (see alignment below).
Alignment of instant CD8a transmembrane domain (SEQ ID NO: 26) with US533 CD8a hinge and transmembrane domain (SEQ ID NO: 182):
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226
712
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Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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 for establishing a background for determining obviousness under 35 U.S.C. 103 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 6, 8, 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2019/0292533 A1 (hereinafter “US533”) as applied to claim(s) 1-4 above, and further in view of Jiang et al. (Human Vaccines & Immunotherapeutics, 2019, VOL. 15, NO. 5, 1111–1122; hereinafter “Jiang”).
The teachings of US533 as recited above are applied.
Regarding instant claim(s) 6, 8, 12, US533 further teaches the transmembrane domain is derived from “monomeric receptors (e.g., PD1)” [e.g., ¶ 0241].
US533 does not expressly teach that the hinge and transmembrane domains are PD-L1 (instant SEQ ID NO: 25).
Regarding instant claim(s) 6, 8, 12, Jiang teaches PD1 and PDL1 are both type I transmembrane glycoproteins that each comprise hydrophobic transmembrane and extracellular IgV domains [e.g., ¶ 1111-1112, “2. Structure of PD-1 and PD-1 Ligands”].
it would have been prima facia obvious to a person having ordinary skill in the art (PHOSITA) before the effect filing date of the claimed invention to try a PDL1 transmembrane and hinge domain as taught by Jiang, in place of the PD1 hinge and transmembrane domains of the chimeric polypeptide taught by US533, to arrive at the instant invention of a chimeric polypeptide comprising a BCMA extracellular domain (ECD), and a PDL1 hinge and transmembrane domain. A PHOSITA would have been motivated to substitute the PD1 hinge and transmembrane domains of US533 with the PDL1 hinge and transmembrane domains as taught by Jiang, because US533 and Jiang both teach PD1 transmembrane and extracellular (e.g., comprising hinge sequence) domains, and Jiang teaches that PD1 and PDL1 are both Type I transmembrane glycoproteins with hydrophobic transmembrane domains and extracellular IgV domains. There would have been a reasonable expectation of success for a PHOSITA to substitute the PD1 hinge and transmembrane domains of US533 with the PDL1 hinge and transmembrane domains as taught by Jiang, because Jiang teaches that PD1 and PDL1 are both Type I transmembrane glycoproteins with hydrophobic transmembrane domains and extracellular IgV domains, and therefore since the domains of each are similarly categorized, they’d reasonably be expected to result in the same function(s) in a fusion protein (e.g., a chimeric polypeptide), despite differing amino acid sequences. This rationale aligns with the “obvious to try” principle of choosing from identified, predictable solutions, with a reasonable expectation of success (see MPEP 2143(I)(E)).
Thus, the invention as a whole is prima facie obvious over the references, especially in the absence of evidence to the contrary.
Allowable Subject Matter
Claim(s) 5, 13-15, 22-24 is/are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claim 5 is drawn to a PDL1 hinge comprising SEQ ID NO: 23, claims 13-15 are drawn to a PDL1 transmembrane domain comprising or consisting of SEQ ID NO: 25, and claims 22-24 are drawn to a TROP2 intracellular region comprising or consisting of SEQ ID NO: 40. While PDL1 hinge and transmembrane domains are considered obvious in view of the closest prior art (see 103 rejection above), no specific hinge or transmembrane sequences are taught in the prior art (e.g., specific residues of PDL1 that would be utilized for hinge, or transmembrane) for fusion/chimeric proteins. Additionally, while TROP2, including TROP2 intracellular domain (ICD), were known in the art at the time of filing, there was no prior art found to suggest utilizing only the intracellular domain for chimeric or fusion proteins (e.g., in place of a 41BB, CD3z, etc.), and additionally no specific teachings of the TROP2 ICD residues that would be required for a functional fusion or chimeric protein were found in the prior art. Given the above, claims 5, 13-15, and 22-24 are considered non-obvious in view of the closest prior art.
Conclusion
No claims are currently allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMY M CHATTIN whose telephone number is (571)270-0646. The examiner can normally be reached T-F 0600-1600 PST.
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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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/AMY M. CHATTIN/Examiner, Art Unit 1643
/GARY B NICKOL/Primary Examiner, Art Unit 1643
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