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 .
Response to Amendment
The Amendment filed June 26, 2026 in response to the Non-final rejection of February 26, 2026 is acknowledged and has been entered.
Claims 89-97, and 100-108 were amended or previously presented. Claims 109-110 were newly added.
Claims 89-97, and 100-110 are currently under consideration.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office Action.
Objections Withdrawn
Specification
The disclosure is no longer objected to as applicants have pointed out that references to colors were removed in a substitute specification filed 14 July 2023.
The disclosure is also no longer objected to for missing sequence identifiers as applicant’s have updated the specification to incorporate the corresponding SEQ IDs
Rejections Withdrawn
The rejection of Claims 89-108 as vague and indefinite for reciting the term “interface” is withdrawn in view of applicant’s amendments to claim 89 which further clarifies the interface region.
The rejection of Claim(s) 89-95, and 100-108 under 35 U.S.C. 102(a)(1) as being anticipated by Chaudhary, P. (WO2018102795, published July 2018) is withdrawn in view of applicant’s amendments to Claim 89.
Rejections Maintained
Claims 89-95 and 100-108 remain rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement for the reasons of record and for the reasons set forth below.
Applicants argue (Response, 06-26-26, page 9) that claim 89 was amended for purposes of clarification to define the various components of the claimed construct. Applicants submit that the currently pending claims recite definitive subject matter and further comply with written description requirements.
This argument has been considered but is not found persuasive. The amendment to claim 89 only provides a limited structure of the VH and VL regions of the TCR because each VH and VL region comprises any number of mutations which still comprises a huge variant pool of potential heavy and light chain domains. In contrast, applicants have only provided a written description of miTCRs directed against the CD19 surface molecule (SEQ IDs 35 and 36) and the specifically defined mutations set forth in claims 96-97. Four plasmid sequences were developed and are directed against the CD19 surface molecule. They employ the FMC63 anti-CD19 antigen-recognition domains. They are paired variable heavy or variable light chains with TCR alpha or beta constant regions to create a single chain antigen receptor. However, the specification teaches [0188, 0205] that even these constructs had issues being expressed on T cells so mutations and optimizations had to be developed. Thus, one of ordinary skill in the art would not recognize that applicants were in possession of the genus of variant heavy and light chains (inclusive of any and all mutations) that would retain structural integrity and still bind CD19. As set forth previously, the specification teaches [0065] that the interface between the engineered VH and VL AND the native TCR are critical to mimicking or restoring the native TCR variable and TCR constant region interface interactions or “reduce stress in the protein”. The length, area, region, or portion of peptides that is closer in proximity to the constant region is relatively stable, while the distal part of the variable chains, which are responsible for antigen binding, are different for each variable chain corresponding to different antigen binding fragments or domains. Thus, Applicant’s arguments have been considered but have not been found persuasive.
News Rejections
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 93-95, 104, 106-107 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. With the amendment of Claim 89 to specific variable heavy (VH) and variable light (VH) chain regions, the “target antigen” can only be CD19. Thus, except for CD19, the alternative target antigens in claims 93-94 and 106 fail to further limit claim 89. This also extends to the types of cancer which express CD19. For example, (Xu et al., Frontier in Immunology, 2019, Applicant’s IDS) teaches that CD19 is a specific B-cell surface marker. Absent evidence to the contrary, only cancers of B-cell lineage would further limit claim 89.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claims 96-97 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.
New claims 109-110 are objected to for being dependent upon a rejected base claim. These claims would not be allowable if rewritten into independent form.
No claim is allowed.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GARY B NICKOL, Ph.D. whose telephone number is (571)272-0835. The examiner can normally be reached M-F 9AM-5:30PM.
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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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/GARY B NICKOL/Primary Examiner, Art Unit 1643
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