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 .
Claims 1, 3-17 and 19-24 are pending and examined on the merits after the amendments.
Applicant’s response (amendment and arguments) is acknowledged. Applicant’s amendments and arguments have overcome the rejection of record; however, upon final review another matter was uncovered that was not previously appreciated and needs to be addressed on the record in order that the metes and bounds of the intended claim scope are set forth.
See also Interview Summary (Attached). Following review of the claim amendments weighed against the preamble language, it was agreed by both applicant’s representative and the examiner that scope issues remained, and that in order to allow applicant sufficient time to address, that an Office action be sent thereto (which the examiner agreed to send as non-final).
The examiner remains open to further interview to advance prosecution on the merits.
Election/Restrictions - Maintained
Applicant’s election without traverse of Group I, claims 1-18, as drawn to the elected peptide species Pep-45 (below), in the reply filed on 9/15/21 is acknowledged:
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The remaining claims 19-24 are withdrawn as not drawn to the elected invention.
The Claimed Invention – Previously Noted
The claimed method relates to the cyclization of a peptide (elected species Pep-45, see above) via an amide bond formed from the reaction of a first reaction point with a second reaction point in the peptide synthesized by translating a nucleic acid encoding a noncyclic peptide, and the amino acid residue of formula I or II (claim 1) having the first reaction point.
Allowable Subject Matter – Previously Noted
A method as claimed of producing the elected peptide of Pep-45 was not found to be reasonably taught or suggested by the prior art of record:
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Applicant’s prior work, now U.S. Patent No. 9,409,952 (applicant’s earlier work) is deemed the closest art of record, but does not teach producing Pep-45.
It is noted that the international authority found the same in the related PCT.
Claim Rejections - 35 USC § 112(b) – New, Preamble v. Amended Claim Scope
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.
Claims 1, 3-17 and 19-24 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.
1. The claims are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite as to the phrase “amino acid analog residues” (see claim 1, line 2), as the term “analog” is not further defined by the claims themselves, and the metes an bounds thereto indefinite. The specification support lends itself to such being “uncommon amino acid residues” which applicant may consider for amendment thereto or some alternative finding support, see the following specification paragraphs 188-190 and 217 for guidance relevant to proposed claim amendment language supported e.g.:
[0188] “Amino acid analogs” include unnatural amino acids (for example, unnatural α-amino acids, β-amino acids, and γ-amino acids). An α-amino acid may be a D-amino acid, or an α,α-dialkylamino acid. In a similar manner to an α-amino acid, a β-amino acid and a γ-amino acid are also allowed to have any configuration. A side chain (with the main chain being methylene) of the amino acid analogs is not particularly limited, and may have, besides hydrogen atoms, for example, an alkyl, an alkenyl, an alkynyl, an aryl, a heteroaryl, an aralkyl, or a cycloalkyl. Each of these may have one or more substituents, and these substituents can be selected from any functional group containing, for example, a halogen atom, an N atom, an O atom, an S atom, a B atom, a Si atom, or a P atom. For example, herein, “C1-C6 alkyl optionally substituted with halogen” means “C1-C6 alkyl” substituted with one or more halogen atoms, and specific examples include trifluoromethyl, difluoromethyl, fluoromethyl, pentafluoroethyl, tetrafluoroethyl, trifluoroethyl, difluoroethyl, fluoroethyl, trichloromethyl, dichloromethyl, chloromethyl, pentachloroethyl, tetrachloroethyl, trichloroethyl, dichloroethyl, and chloroethyl. Furthermore, for example, “optionally substituted C5-C10 aryl C1-C6 alkyl” means that in which at least one hydrogen atom of the aryl and/or alkyl of “C5-C10 aryl C1-C6 alkyl” has been substituted with a substituent. Furthermore, “cases having two or more substituents” include cases having an S atom-containing functional group, which further has functional groups such as an amino or a halogen.
[0189] The main chain amino group of an amino acid analog may be unsubstituted (a NH.sub.2 group), or it may be substituted (that is, an NHR group; in which R represents an alkyl, an alkenyl, an alkynyl, an aryl, a heteroaryl, an aralkyl, or a cycloalkyl, each of which optionally has a substituent; or a carbon chain bonded to the N atom and a carbon atom at the a position may form a ring as in proline. The substituent is similar to the substituent of the side chain, and examples include a halogen, an oxy, and a hydroxy.). Furthermore, for “an alkyl, an alkenyl, an alkynyl, an aryl, a heteroaryl, an aralkyl, or a cycloalkyl” in the definition of these substituents, the above-mentioned definitions for these functional groups are applied. For example, herein, “alkoxy” means a group in which a hydrogen atom in a hydroxy group is replaced with the above-mentioned alkyl group. Preferred examples thereof include “C1-C6 alkoxy”.
[0190] Furthermore, “amino acid analogs” include hydroxycarboxylic acids in which an amino group of an “amino acid” has been replaced with a hydroxyl group. The hydroxycarboxylic acid may have various substituents, in a similar manner to other amino acid analogs. The hydroxycarboxylic acid may have a configuration corresponding to either an L- or D-form amino acid. While its side chain is not particularly limited, for example, it is selected from an alkyl, an alkenyl, an alkynyl, an aryl, a heteroaryl, an aralkyl, a cycloalkyl, and such, which are optionally substituted.
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[0217] Exemplary unnatural amino acids (amino acid analogs) that can be used other than at the N terminus in the present invention are shown below; however, the unnatural amino acids are not limited thereto. Many of these unnatural amino acids can be purchased with their side chains protected or unprotected and their amine moieties protected or unprotected. Those that cannot be purchased can be synthesized by known methods.
2. The claims rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite as to the term “portion” in the context of the phrase “a cyclic portion” relevant to the peptide being prepared comprising such. The claims do not sufficiently set forth what “portion(s)” is being referred to as presently claimed. Applicant may consider amending the claims to a “cyclic peptide”; however, this does not seem to capture the spirit of the structures claimed. As evidenced by the following sections, specifications paragraphs 169, 171 and 172, the metes and bounds of “cyclic portion” are not clearly defined either as described or claimed, as to what falls inside or outside said scope, after amendment:
[0169] Scheme A describes the peptide moiety (before and after cyclization) in a peptide-nucleic acid complex of the present invention. The open circle (◯) unit (intersection unit), filled circle (.circle-solid.) unit (cyclic portion main chain unit), square (.square-solid.) unit (linear portion main chain unit), and the triangle (.box-tangle-solidup.) unit (cyclized N-terminal unit) each denote an amino acid constituting the peptide moiety. The respective units may be the same or different amino acids.
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[0171] In Scheme A, the cyclic portion is moiety composed of one triangle unit, eight filled circle units, and one open circle unit, and the linear portion is a moiety composed of six square units. The curved portion in Scheme A is a site cyclized after translation (posttranslationally cyclized site) and this portion is linked by an amide bond.
[0172] Peptides or peptide moieties of the present invention require a reactive functional group on the triangle unit or the intersection unit described in Scheme A; therefore, a drug-like amino acid is not necessarily selected for the triangle unit or the intersection unit. Furthermore, in the present invention, the cyclic portion preferably includes two or more amino acid analog residues.
Further amendment and arguments thereto are required to address the above.
Prior Art Made of Record But Not Relied Upon
U.S. Patent No. 9,409,952
U.S. Patent No. 11,891,457
U.S. Patent No. 12,415,835
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MAURY AUDET whose telephone number is (571)272-0960. The examiner can normally be reached on M-Th. 7AM-5:30PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Lianko Garyu can be reached on 571-270-7367. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MAURY A AUDET/Primary Examiner, Art Unit 1654
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