DETAILED ACTION
This application is being examined under AIA first-to-file provisions.
Continued examination under 37 CFR 1.114
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous office action has been withdrawn pursuant to 37 CFR 1.114. MPEP 706.07(h) pertains.
Status of claims
Canceled:
2, 7-14, 16-17, 19-22
Pending:
1, 3-6, 15, 18 and 23-34
Withdrawn:
23 and 30-33 (Per Applicant's 2/18/2026 remarks, claims 27-28 are rejoined.)
Examined:
1, 3-6, 15, 18, 24-29 and 34
Independent:
1
Allowable:
none
Rejections applied
Abbreviations
x
112/b Indefiniteness
PHOSITA
"a Person Having Ordinary Skill In The Art before the effective filing date of the claimed invention"
112/b "Means for"
BRI
Broadest Reasonable Interpretation
x
112/a Enablement,
Written description
CRM
"Computer-Readable Media" and equivalent language
112 Other
IDS
Information Disclosure Statement
102, 103
JE
Judicial Exception
101 JE(s)
112/a
35 USC 112(a) and similarly for 112/b, etc.
101 Other
N:N
page:line
Double Patenting
MM/DD/YYYY
date format
Priority
As detailed on the 9/15/2020 filing receipt, this application claims priority to as early as 9/8/2014. At this point in examination, all claims have been interpreted as being accorded this priority date.
Withdrawal / revision of objections and/or rejections
In view of the amendment and remarks:
The objections to the drawings are withdrawn, except as noted below.
The previous 112/b rejections are withdrawn, except as noted below.
The 103 rejections are withdrawn, as further described below.
Rejections and/or objections not maintained from previous office actions are withdrawn. The following rejections and/or objections are either maintained or newly applied. They constitute the complete set applied to the instant application.
Objection to the drawings
The 2/18/2026 supplemental drawings are objected to because they contain sequence disclosures that are encompassed by the definitions for nucleotide and/or amino acid sequences set forth in 37 CFR 1.821(a)(1) and (a)(2). However, this application does not comply with the requirements of 37 CFR §§ 1.821-1.825 for the following reasons:
Nucleotide and/or amino acid sequences appear in FIG. 15, within the lower-left quadrant of the graph, but the sequences have not been identified with SEQ ID numbers in either the figure or the specification's §"DESCRIPTION OF THE FIGURES" (p. 30, line 24 through p. 31, line 13). MPEP § 2422 pertain.
Sequences of 10 or more nucleotides and 4 or more amino acids must be identified by sequence identification number, and a listing including the sequences must be supplied. It is often convenient to identify sequences in figures by amending the Brief Description of the Drawings section (MPEP 2422.02 pertains).
Applicants are required to comply with all the requirements of 37 CFR 1.821-1.825. Any response to this action which fails to meet these requirements will be non-responsive.
This objection is maintained.
Claim rejections - 112/b
The following is a quotation of 35 USC 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.
Claims 1, 3-6, 15, 17-18, 24-26, 29 and 34 are rejected under 112/b, as indefinite for failing to particularly point out and distinctly claim the subject matter which applicant regards as the invention. Claims depending from rejected claims are rejected similarly, unless otherwise noted, and any amendments in response to the following rejections should be applied throughout the claims, as appropriate. With regard to any suggested amendment below, for claim interpretation during the present examination it is assumed that each amendment suggested here is made. However equivalent amendments also would be acceptable.
The following issues cause the respective claims to be rejected under 112/b as indefinite:
Claim
Recitation
Comment (suggestions in bold)
1
Synthesizing... the amino acids
The recited "the amino acids" requires but lacks clear antecedent. Possibly "the" should be deleted.
This rejection is maintained.
28
the autoimmune disease
Requires but lacks clear antecedent. For compact examination, it is assumed that claim 28 will be amended to depend from claim 27.
Claim rejections - 112/a
The following is a quotation of 112/a:
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
Written description
Claims 1, 3-6, 15, 18, 24-29 and 34 are rejected under 112/a as failing to comply with the written description requirement. The claims read on subject matter which is not described in the specification in such a way as to reasonably convey to PHOSITA that the inventors, at the time the application was filed, had possession of the claimed invention. Claims depending from rejected claims are rejected similarly, unless otherwise noted. With regard to any suggested amendment(s) below to overcome a rejection, equivalent amendments also would be acceptable.
Claim 1 recites "...reducing the count of T cell clones... by exhaustion or anergy..." and "...the count of T cell clones is reduced by exhaustion or anergy..." The specification does not appear to disclose any form of "exhaustion" or "anergy," including not in the context of reducing T cell count. The written description provided is not clearly commensurate with the recitation.
Although claims are interpreted in light of the specification, examples from the specification are not imported into the claims as limitations absent a clearly limiting definition in the specification. (MPEP 2145.VI pertains.)
As appropriate, these rejections may be overcome, for example, (i) by narrowing to clearly supported embodiments and/or (ii) by clarifying on the record where support can be found and how that support relates to the recitations.
In general, it is requested that any claim amendment in this regard be accompanied by citations to support in the original disclosure.
MPEP 2163 generally pertains.
No prior art has been applied to the following claims
Claims 1, 3-6, 15, 18, 24-29 and 34 are free of the analogous art at least because close art, e.g. as cited in the now withdrawn art rejections as well as art found on the IDSs and in the search histories, either individually or in obvious combination, does not teach the recited combination of synthesizing and administering a T cell exposed motif with substituted flanking amino acids to achieve a desired binding so that the count of T cell clones is reduced by exhaustion or anergy. Additionally, Applicant's 2/18/2026 remarks at p. 7-10 supported the withdrawal of the rejection.
Patent eligibility - 101 -- NO REJECTION
Referring to 101 JE analysis as organized in MPEP 2106, no rejection applies to claims 1, 3-6, 15, 17-18, 24-26, 29 and 34, at least by analogy to:
the analysis step 2A, 1st prong, in that the instant claims are not directed to a JE and
the analysis step 2A, 2nd prong, 2nd consideration, relating to a therapy, e.g. the instant "administering" step.
Conclusion
No claim is allowed.
A shortened statutory period for reply is set to expire THREE MONTHS from the mailing date of this communication.
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The examiner for this Office action, G. Steven Vanni, may be contacted at:
(571) 272-3855 Tu-F 8-7 (ET).
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Larry D. Riggs, II, may be reached at (571) 270-3062.
/G. STEVEN VANNI/Primary patents examiner, Art Unit 1686 (previously 1672)