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 .
Election/Restrictions
Applicant’s election without traverse of Group II, claim(s) 14-15 and 17-18, drawn to compositions comprising one or more RNA molecules in the reply filed on 03/30/2026 is acknowledged.
Claims 1-10, 13, 24, 27, 29 and 36-37 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 03/30/2026.
Applicant’s election without traverse of SEQ ID NO: 1080, drawn to a first RNA molecules and SEQ ID NO: 1182, drawn to a second RNA molecules in the reply filed on 03/30/2026 is acknowledged.
Applicant statement that “Applicant believes that claims 14-15 and 17-18 read on the elected subject matter,” is acknowledged.
STATUS OF CLAIMS
Claims 1-10, 13-15, 17-18, 24, 27, 29, and 36-37 are pending.
Claims 1-10, 13, 24, 27, 29 and 36-37 are withdrawn,
Claims 14-15 and 17-18 are under examination on the merits in this office action.
Priority
Applicant’s claim to the benefit of U.S. Provisional Application Nos. 63/147,168, filed February 8, 2021, and 63/125,200, filed December 14, 2020, is denied. Both provisional applications lack written description support for “17-50 contiguous nucleotides” as claimed, rather the provisional describe the range to be “17-30 contiguous nucleotides.” Furthermore, both provisional applications lack written description support for all SEQ ID NOs claimed; for example, instant SEQ ID NO: 1932 does not have support. Therefore, the examiner is considering the effective filing date to be that of the application no. PCT/US21/63290, filed 12/14/2021.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 06/13/2023 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Improper Markush Grouping
Claims 14-15 and 17-18 are rejected on the basis that it contains an improper Markush grouping of alternatives. See In re Harnisch, 631 F.2d 716, 721-22 (CCPA 1980) and Ex parte Hozumi, 3 USPQ2d 1059, 1060 (Bd. Pat. App. & Int. 1984). A Markush grouping is proper if the alternatives defined by the Markush group (i.e., alternatives from which a selection is to be made in the context of a combination or process, or alternative chemical compounds as a whole) share a “single structural similarity” and a common use. A Markush grouping meets these requirements in two situations. First, a Markush grouping is proper if the alternatives are all members of the same recognized physical or chemical class or the same art-recognized class, and are disclosed in the specification or known in the art to be functionally equivalent and have a common use. Second, where a Markush grouping describes alternative chemical compounds, whether by words or chemical formulas, and the alternatives do not belong to a recognized class as set forth above, the members of the Markush grouping may be considered to share a “single structural similarity” and common use where the alternatives share both a substantial structural feature and a common use that flows from the substantial structural feature. See MPEP § 2117.
The Markush grouping of in any one of SEQ ID NOs: 1- 1932 is improper because the alternatives defined by the Markush grouping do not share both a single structural similarity and a common use for the following reasons: the sequences do not share a common core motif (i.e., core sequence structure). For example, the elected species, SEQ ID NO: 1080 and 1182, only share 24.5% identity with only three contiguous bases matching. By virtue of claim dependency, all dependent claims from claim 14 necessary and inherently recite the limitations of claim 14 which recites the improper Markush group, in any one of SEQ ID NOs: 1- 1932, furthermore, the comparison of the elected species applies to each of claims 14-15 and 17-18.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 14-15 and 17-18 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a naturally occurring molecule (i.e., product of nature) without significantly more. Under broadest reasonable interpretation, the claims are interpreted as being drawn to the naturally occurring human T-cell receptor alpha constant (TRAC) mRNA molecule or fragments thereof. For example, SEQ ID NO: 1 and SEQ ID NO: 1080 map with 100% identity to GenBank Accession No. X02592.1, which defines the TRAC mRNA molecule (see analysis below). This judicial exception is not integrated into a practical application because the claims merely recite the molecules without any additional limitations that transform the nature of the claims into a specific, non-natural application. The recitation of a naturally occurring sequence does not perform a function beyond its inherent biological nature, and the claims lack any specific step or technology that would integrate the sequences into a practical technological process. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because there are no additional elements claimed that would amount to significantly more than the judicial exception. Claiming a naturally occurring RNA sequence, even if isolated or synthesized to match the natural closest counterpart, does not add an inventive concept because the sequence’s structure and function are dictated by nature. There is no “significantly more” provided that transforms the product of nature into a patent-eligible invention.
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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.
Claims 14-15 and 17-18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Chen et. al., (US20180362975A1).
Regarding claims 14-15, Chen teaches a composition comprising an RNA molecule which comprises 17-50 contiguous nucleotides containing nucleotides in the sequence set forth in SEQ ID NO: 1 and 1080 ([103]: “a composition including a first gRNA molecule,” and [0005]: “a gRNA molecule including a tracr and crRNA, wherein the crRNA includes a targeting domain that is complementary with a target sequence of an allogeneic T-cell target selected from…TRAC…,” and [0008]: “the allogeneic T-cell target is TRAC, and the targeting domain includes any one of SEQ ID NO: 5528 to SEQ ID NO: 5623 or SEQ ID NO: 5816 to SEQ ID NO: 5965”). SEQ ID NO: 5818 of Chen comprises 100% sequence identity to instant SEQ ID NO: 1, and SEQ ID NOs: 5821-5832 comprise 100% sequence identity to instant SEQ ID NO: 1080.
Regarding claims 17-18, Chen teaches the composition further comprises a second RNA molecule which comprises 17-50 contiguous nucleotides containing nucleotides in the sequence set forth in any one of SEQ ID NOs: 1-1932 ([0104]: “the composition may include more than one gRNA molecule,” and “the composition further includes a second gRNA molecule,” and “wherein each gRNA molecule of the composition is complementary to a different target sequence,” and “are complementary to target sequences within the same gene” or “are complementary to target sequence within different genes or loci.”). Chen further teaches “1, 2, 3, 4, 5 or more mismatch nucleotides relative to the sequence of the targeting domain of the gRNA,” see [0477]. SEQ ID NO: 5818 of Chen comprises 100% sequence identity to instant SEQ ID NO: 1, and SEQ ID NOs: 5821-5832 comprise 100% sequence identity to instant SEQ ID NO: 1080.
Claims 14-15 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Wessells et. al., (US20240026351A1).
Regarding claims 14-15, Wessells teaches a composition comprising an RNA molecule which comprises 17-50 contiguous nucleotides containing nucleotides in the sequence set forth in any one of SEQ ID NOs: 1- 1932 (claim 1: “a composition comprising an RNA guide, wherein the RNA guide comprises (i) a spacer sequence that is substantially complementary to a target sequence within a TRAC gene,” and claim 2: “wherein the target sequence is within exon 1, exon 2, exon 3, or exon 4 of the TRAC gene,” and claim 4 “wherein the spacer sequence comprises: … g. nucleotide 1 through nucleotide 22 of a sequence that is at least 90% identical to a sequence of any one of SEQ ID NOs: 174-336”). SEQ ID NOs: 215-216 of Wessells comprises 100% sequence identity to instant SEQ ID NO: 1080, and SEQ ID NOs: 48-50 and 211-213 comprise 100% sequence identity to instant SEQ ID NO: 1182.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to COREY LANE BRETZ whose telephone number is (571)272-7299. The examiner can normally be reached M-F 7:30am - 6:30pm.
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/COREY LANE BRETZ/Patent Examiner, 1635
/RAM R SHUKLA/Supervisory Patent Examiner, Art Unit 1635
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