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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 6/10/26 has been entered.
Election/Restrictions and Claim Status
Applicants’ amendments and arguments filed 6/10/26 are acknowledged. Although unclear (see 112 rejection below), the claims are interpreted such that they are 101 compliant (specifically that a C-terminal modification is present). Any other objection or rejection from the 3/11/26 office action that is not addressed below is withdrawn based on the amendments.
Previously, the species of SEQ ID NO:10 was elected and applicants stated that claims 1-2, 6-7 and 17-20 read on the elected species.
Claims to the elected species are rejected as set forth below. Any relevant art that was uncovered during the search for the elected species is cited herein in order to advance prosecution.
Claims 3-5 and 8-16 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 8/12/25.
Claim 2 has been canceled.
Claims 1, 6-7 and 17-20 are being examined.
Priority
The priority information is found in the filing receipt of 2/23/23.
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 1, 6-7 and 17-20 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.
Claim 1 recites ‘the C-terminus is one in which..’. The meaning of such phrase in the context of claim 1 is unclear. Claim 1 refers to 2 different occurrences of the C-terminus (see formula I and formula II). It is unclear if referring to ‘one in which…’ means that only one of the formulas is being referenced. It appears that the intent might be that at least under certain conditions that the C-terminus is substituted with -NH2. If so, it is unclear if claim 7 is a proper dependent claim. Claim 7 uses the closed ‘consists of’ language but does not show any peptides with a substituted C-terminus. The elected peptide does not appear to include a substituted C-terminus. As such, the scope and intent of the scope is unclear. Further, claim 1 refers to ‘N-terminus’ and ‘C-terminus’. It is unclear if such descriptors are merely used to indicate the location (see formulas) or if such descriptors indicate the location and structure. For example, it is unclear if ‘N-terminus’ is requiring an unmodified N-terminus or if it is merely indicating the location of the N-terminus (where the N-terminus can be modified or unmodified). The specification does recognize modifications to a terminal end (page 3 lines 2-3 of the 12/31/25 substitute specification). Claim 1 does recite ‘A consists of’, ‘B consists of’ and ‘C consists of’ which is closed language for those components. However, it is unclear if ‘N-terminus’ is only an unmodified N-terminus or if it can be modified. As such, the structures encompassed by the claims are unclear. None of the dependent claims clarifies the claim scope. Although unclear, the claims have been given the broadest reasonable interpretation consistent with the specification.
Claim Rejections - 35 USC § 102
The rejections below are new rejections
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1, 6-7 and 17-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Diamond (US 6,632,435).
Diamond teach a C-hydroxyl (H-A1-Y9-COOH) L-amino acid combinatorial nonapeptide library and a C-amide (H-A1-Y9-CONH2) nonapeptide library arranged in a positional scanning format (example 6 columns 15-16). Diamond teach that each library consists of 180 mixtures in the OX8 format where O represents one each of the 20 natural L-amino acids and X represents any of the 20 natural amino acids with the exception of cysteine in each of the remaining positions (example 6 columns 15-16). Diamond teach that each mixture consisted of 198 different nonamer peptides (example 6 columns 15-16).
In relation to claims 1 and 6-7, the nonapeptide library of Diamond is of sequence OX8 where O represents one each of the 20 natural L-amino acids and X represents any of the 20 natural amino acids with the exception of cysteine in each of the remaining positions (example 6 columns 15-16). Diamond teach that each mixture consisted of 198 different nonamer peptides (example 6 columns 15-16). Thus, when O is Arg, the H-A1-Y9-CONH2 library necessarily comprises Arg-Arg-Arg-Trp-Ile-Trp-Val-Leu-Trp-NH2 which comprises instant SEQ ID NO:84 and comprises SEQ ID NO:9. and is of instant formula I where X1, X2 and X3 are Arg; Z1-Z2 is Ile; Z3-Z4 is Val; a, b and c are 1; I, j, k and l are 0. Although the claims are unclear (see 112 rejection above), Diamond teach both unmodified terminal ends (H-A1-Y9-COOH) as well as a C-terminal amide (H-A1-Y9-CONH2). Since the peptide is of the sequence as claimed it would function as claimed.
In relation to claims 17-20, Diamond teach that each mixture consisted of 198 different nonamer peptides (example 6 columns 15-16) so the peptide was present in a composition and there is nothing to preclude the mixture as an antibiotic, or cosmetic or food or additive.
Claim(s) 1, 6-7 and 17-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Maynard et al. (‘Structure of an autoimmune T cell receptor complexed with class II peptide-MHC: insights into MHC bias and antigen specificity’ 2005 Immunity v22 pages 81-92; ‘Maynard’).
Maynard teach a C-terminal amidated L-amino acid combinatorial decapeptide library arrayed in a positional scanning format that consists of 200 mixtures in the OX9 format where O represents one each that 20 natural L-amino acids in a defined position and X represents all of the natural amino acids with the exception of cysteine (page 90 ‘Libraries and Peptides’). Maynard teach that each OX9 mixture consists of 199 different decamer peptides(page 90 ‘Libraries and Peptides’).
In relation to claims 1 and 6-7, the decapeptide library of Maynard is of sequence OX9 where O represents one each of the 20 natural L-amino acids and X represents any of the 20 natural amino acids with the exception of cysteine in each of the remaining positions (page 90 ‘Libraries and Peptides). Maynard teach that each mixture consisted of 199 different decamer peptides (page 90 ‘Libraries and Peptides’). Thus, when O is Arg, the library necessarily comprises Arg-Arg-Arg-Trp-Ile-Trp-Val-Leu-Trp-Lys-NH2 which comprises SEQ ID NO:10 and comprises SEQ ID NO:9. and is of instant formula I where X1, X2 and X3 are Arg; Z1-Z2 is Ile; Z3-Z4 is Val; X5 is Arg; a, b, c and i are 1; j, k and l are 0. Although the claims are unclear (see 112 rejection above), Maynard teach a C-terminal amidated L-amino acid combinatorial decapeptide library (page 90 ‘Libraries and Peptides’). Since the peptide is of the sequence as claimed it would function as claimed.
In relation to claims 17-20, Maynard teach that each OX9 mixture consists of 199 different decamer peptides(page 90 ‘Libraries and Peptides’) so the peptide was present in a composition and there is nothing to preclude the mixture as an antibiotic, or cosmetic or food or additive.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RONALD T NIEBAUER whose telephone number is (571)270-3059. The examiner can normally be reached M - F 6:30 - 2:30 EST.
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RONALD T. NIEBAUER
Primary Examiner
Art Unit 1658
/RONALD T NIEBAUER/Examiner, Art Unit 1658
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