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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 4/10/2026 has been entered.
This application has been re-assigned to Examiner Karen Canella.
After review and consideration, the election of species requirement of 9/26/2023 is withdrawn. Claims 16, 35, 39, 42, and 95 and hereby rejoined for examination at this time.
Claims 21, 31, 88, 93 have been canceled. Claims 1, 2, 39, 64, 68, 70, 95 and 105 have been amended. Claims 1, 2, 4, 8, 9, 14, 16, 35, 39, 42, 43, 64, 68, 70, 84, 95 and 105 are pending and under consideration.
The objection to claims 1, 2, 4 and 68 are withdrawn in light of applicant’s amendments and arguments regarding the term “providing”
After review and consideration, the rejection of claims 1, 2, 4, 8, 9, 14, 43, 64, 68, 70, 84, and 105 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112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement is withdrawn.
The rejection of claims 1, 2, 4, 8, 9, 14, 16, 35, 39, 42, 43 64, 68, 70, 84 95 and 105 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for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention for reasons of record, is withdrawn.
New Grounds of Rejection
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.
Claim 43 is 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. Claim 43 states that the CAR-antigen recognition domain of claim 1 binds to a disease associated antigen or a tumor-associated antigen. This fails to further modify claim 1 because the CAR-antigen recognition domain is required to be an antigen binding domain of FMC63 antibody comprising a heavy chain variable region of SEQID NO: 71 and a light chain variable region of SEQ ID NOL 72. As such, the antibody paratope is defined by the pairing of the CDR sequences in the heavy and light chain and the epitope bound by the paratope is fixed. Stating that the recognition domain binds to a disease associated antigen or a tumor-associated antigen fails to further modify the CAR-antigen recognition domain of claim 1. 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.
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, 2, 4, 8, 9, 14, 16, 35, 39, 42, 43, 64, 68, 70, 84, 95 and 105 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.
(A)Claim 1 is vague and indefinite in the recitation of “a method of identifying a peptide ligand” as a method objective, but no ligand is identified by the active method steps which culminate in the selection of a peptide sequence motif, which is not a peptide ligand.
(B)(i)Claim 1 is vague and indefinite in the recitation of “selecting a peptide sequence motif that binds the CAR-antigen recognition domain with a KD of at least 5 uM” based on a positive selection step after a negative selection step or steps, wherein the population of cells from the library which bind to the second solid support comprises the CAR-antigen-recognition domain. There is no recitation in claim 1(ii) that insure that the bound cells represent or comprise a peptide sequence motif having a KD of at least 5 uM. Applicant’s intent is unclear.
(C) It is unclear how binding affinity of the peptide sequence motif for the CAR antigen recognition domain is to be determined in claims 1 and 95 because the motif can be “weighted” with predominant amino acids at certain locations within the motif and less prominent amino acids at other locations, such that a mixture of cells can represent a motif, but that mixture is skewed toa number of predominant species. It is noted that claim 1(ii) requires only one or two rounds of positive selection. Thus, the number of rounds of selection can influence the composition of the cellular mixture comprising the peptide binding motif such that the KD will change with the particular cellular composition as a function of the number of positive selection rounds.
In claims 64 (ii)b and 1(ii)B the contacting of the population of cells directly after the negative selection and selection of cell that are labeled with fluorescently tagged antibody of a fragment thereof, does not provide for the peptide sequence motif required as the objective of claim 1 (ii) or a CAR-antigen-binding domain having a binding affinity, KD, of at least 5 uM, nor does it provide for the identification of a peptide ligand with enhanced binding to a CAR antigen-recognition domain in claim 64. Thus, the claims are vague and indefinite,
The term “enhanced” in claim 64 is a relative term which renders the claim indefinite. The term “enhanced” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is unclear what threshold for binding to the CAR-antigen recognition domain in claim 64 qualifies for “enhanced binding”.
Claim 84 is vague and indefinite in the recitation of the nucleotide sequence from 5’ to 3’ represented by the formula [P]-[T]-[L]-[V] which appears to be a polypeptide because it requires Ag2p and the variable peptide, and thus, cannot be a nucleotide sequence.
The following is a quotation of the first paragraph of 35 U.S.C. 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.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
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 of carrying out his invention.
Claims 64, 68, 70, 84 , 95, and 105 are 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. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 64 requires the sequence motif identified by the method of claim 1 as “M”. Because it is not possible to adequately describe something that has yet to be determined, the sequence motif of “M” lacks adequate written description.
All claims are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KAREN A CANELLA whose telephone number is (571)272-0828. The examiner can normally be reached M-F 10-6:30.
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KAREN A. CANELLA
Examiner
Art Unit 1643
/Karen A. Canella/Primary Examiner, Art Unit 1643
