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 .
Claim Status
Claims 3, 8-9, 19-20, and 22 are cancelled. Claims 1-2, 4-7, 10-18, 21, and 23-26 as filed on 24 October 2024 are pending and under examination.
Drawings
The subject matter of this application admits of illustration by a drawing to facilitate understanding of the invention. Applicant is required to furnish a drawing under 37 CFR 1.81(c). No new matter may be introduced in the required drawing. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d).
Applicant specification references Figures 1-8 in the specification on page 4 in line 15-36 to page 7 to line 27. No drawings are attached. Examiner notes the Certified copy of GB2113437.4 contains drawings 1-8 which appear to match the figure description in the instant disclosure.
Specification
The disclosure is objected to because of the following informalities: The specification includes Figure Descriptions on page 4 in line 15-36 to page 7 to line 27 and further references figure throughout the disclosure with no figures included in the application.
Appropriate correction is required.
Claim Objections
Claim 16 is objected to because of the following informalities: claim 16 subparts (i) and (ii) are identical and appear to be duplicated sentences. Appropriate correction is required.
Claim Rejections - 35 USC § 112
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 24 and 26 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.
Claims 24 and 26 contain the term “preferably”. Claim 24 is to a method of treating “ . . . acute lymphoblastic leukemia, preferably of T cell origin or B cell origin.”
Claim 26 is to a method of generating a TDT specific cell “. . . wherein the cell is a T cell or an NK cell, or a precursor therefor, preferably wherein the T cell is a T helper cell or a cytotoxic T cell.”
The use of “preferably” renders both claims indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention or only exemplary language.
Allowable Subject Matter
Claims 1-2, 4-7, 10-18, 21, 23 and 25 are allowed.
The claims are to a binding protein capable of specific binding to an HLA complex type A2 presenting a peptide having either amino acid sequence of SEQ ID NO: 15 or 1 wherein the protein comprises an α-chain and ß-chain and the chains comprise one of the combinations below:
α-chain of CDR 1, 2, and 3 of SEQ ID NO: 16, 17, and 18; with ß-chain of CDR 1, 2, and 3 of SEQ ID NO: 19, 20, and 21; or
α-chain of CDR 1, 2, and 3 of SEQ ID NO: 2, 3, and 4; with ß-chain of CDR 1, 2, and 3 of SEQ ID NO: 5, 6, and 7.
The claims are further to nucleic acid molecules encoding the binding protein of the claims and to a method of generating a TdT specific cell by introducing the recombinant nucleic acid into a cell in the form of a vector. The claims are to a method of treating cancer with the binding protein of the claims.
The closest prior art is Mahr (WO 2017174645 A1) (IDS). Mahr teaches peptides bound by TCRs that bind SEQ ID NO: 3 which matches instant SEQ ID NO: 15 (abstract and Table 1). Mahr either alone or in combination with the prior art does not teach the CDRs of the α-chain and ß-chain of the binding proteins of the claims. The CDRs of the α-chain and ß-chain provide the binding specificity and changes to the amino acids of the CDRs would change binding activity in unpredictable ways making changes to the CDRs not obvious.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to FRANCESCA EDGINGTON-GIORDANO whose telephone number is (571)272-8232. The examiner can normally be reached Mon - Fri 8:00 - 5:00.
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/F.E./Examiner, Art Unit 1643
/JULIE WU/Supervisory Patent Examiner, Art Unit 1643
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