This Office Action Supersedes the Previous Action Mailed by the Office
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 .
Application Status
Claims 1-10 and 45-50 are pending and are examined on the merits herein.
Grounds of Rejection Withdrawn
Previous objection to claims 45, 47-48, and 50 are withdrawn in view of claim amendments.
Previous rejection of claims 1-10, 45, and 48 under U.S.C. 112(a) are withdrawn in view of applicant’s arguments (see explanation below).
Claim Rejections - 35 USC § 112(b)
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.
Claims 1-10 and 45-50 are 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.
The claims recite V genes in a TCR by gene location (TRAV5, TRAV19, TRBV6-6, TRBV12-3, TRBV17 and TRB27) without identifying the allele and therefore render the claims indefinite as the ordinary artisan does not know which nucleotide sequence is required by the claim.
Claims 2-8 and 10 depend from claims 1 and 9 without rectifying this issue and are therefore included in this rejection.
Claims 45, 47-48, and 50 only partially resolve the issue by only requiring a single fully defined J sequence.
Response to Arguments
Applicant's arguments filed July 28, 2026 have been fully considered but they are not persuasive.
Applicant submits: In the Office Action summary, claims 46 and 49 are listed as rejected, however, within the body of the Office Action no grounds for rejection of these two claims are given. Indeed, claims 46 and 49 recite the J genes for each TCR which appears to be what the Office Action is requiring. As such, it is unclear why these claims were rejected. Rather, they should merely be objected to as depending from a rejected claim and should be indicated to be allowable if they were drafted in independent form.
In Response: Claims 46-47 and 49-50 are addressed in the new 112(b) rejection above. The examiner apologizes for the oversight.
Applicant submits: The fact that CDR-A1, CDR-A2, CDR-B1 and CDR-B2 are determined by the germline V gene is well known in the art. As proof of this, Applicant provides with this response a review from 2015 by Attaf et al. This review states explicitly "The process of V(D)J recombination is such that CDRla, CDR1l3, CDR2a and CDR23 are entirely encoded in germline DNA segments. In contrast, the CDR3 loops are the product of junctional diversity and are consequently hypervariable (Figure lb)" (second paragraph of the introduction, emphasis added).
In response: As detailed in the new 112(b) rejection above; while the V gene does contain CDR1 and CDR2 it does not provide the ordinary artisan with the final CDR amino acid sequence as there are multiple known alleles at the recited locations with known differences in nucleotide sequence. An example can be seen in the alignment for IMGT TRBV6-6 below:
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Applicant submits: It should be noted that claim 45 provides the full sequence of the V genes. Certainly, there can be no question that this claim provides the sequence of the CDRls and CDR2s. The sequence is given explicitly, any potential recombination that could have occurred is irrelevant in light of the presentation of the sequences that encompass all six CDRs.
In response: Claims 45, 47-48 and 50 do list specific sequences for the alpha and beta V genes but does not require both of them as the claims recite “at least one of” so these claims do not rectify the issue of not specifying the complete TCR sequence.
Applicant’s arguments, see page 13, filed 07/28/2026, with respect to written description have been fully considered and are persuasive. The rejection of 05/04/2026 has been withdrawn.
Applicant submits: By providing the V gene for each TCR the claim is providing the CDR1 and CDR2 sequences. The sequences are given explicitly. Thus, all 6 CDRs are given for each TCR and there is full written description.
In light of the provision of all 6 CDRs for each TCR claim 1 has proper written description and so do all claims that depend from claim 1. The rejection is rendered moot.
In Response: The examiner agrees that the delineation of the specific CDR3 sequences and the V genes for both the alpha and beta chains of the TCR identifies all 6 CDRs, although not clearly in view of the 112(b) rejection detailed above. However, it is sufficient to overcome the written description requirement.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMBER K FAUST whose telephone number is (703)756-1661. The examiner can normally be reached Monday - Thursday 9:00am-6:00pm EST.
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/AMBER K FAUST/Examiner, Art Unit 1643
/GARY B NICKOL/Primary Examiner, Art Unit 1643
