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 .
DETAILED ACTION
Claim Status
Claims 1-3 and 5-20 are pending. Claim 4 has been canceled. Claim 1 has been amended. Claims 1, 9-11 and 19 are being examined in this application. In the response to the restriction requirement, Applicants elected Group I, wherein R1 is SHRGY, Z is absent n is 0, the synthetic peptide is linear and unmodified, the pharmaceutical composition is in the form of an eye drop and formulated for topical administration, and wherein the kit does not include other compounds. Claims 2-3, 5-8, 12-18 and 20 are withdrawn as being drawn to a nonelected species/invention.
Claim Rejections - 35 USC § 102
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.
This rejection has been modified.
Claims 1, 9-11 and 19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lajoie et al. (WO 2012/061937).
With respect to claim 1, Lajoie et al. teach a method of treating a wound in a mammal comprising administering to the mammal a therapeutically effective amount of a cyclic analogue of histatin 5 or a functionally equivalent derivative thereof (claim 1), wherein the cyclic analogue comprises the sequence RHHCYKRFHEKCHSHRGY (SEQ ID No. 25) (claim 3), which corresponds to the instantly claimed peptide of formula (I), wherein Z is an exogenous peptide, R1 is SEQ ID NO: 1, X is R, and n is 0.
Lajoie et al. also teach that the cyclic histatin analogue comprises the sequence RHHGYKRFHEKHHSHRGY (SEQ ID No. 25) in which one or two of the amino acid residues is substituted with an amino acid selected from the group consisting of cysteine, glutamic acid, lysine and a thiol-containing amino acid to permit cyclization (para [0019]).
Therefore, the cyclic analogue RHHCYKRFHEKCHSHRGY forms a disulfide bridge between the two cysteine residues.
With respect to claim 9, Lajoie et al. teach a composition suitable for wound treatment comprising a cyclic analogue of histatin 5 or a functionally equivalent variant thereof and at least one pharmaceutically acceptable carrier (claim 11).
With respect to claims 10-11, Lajoie et al. teach the dosage may be administered orally, by injection, mucosally and topically (para [0026]).
With respect to claim 19, Lajoie et al. teach an article of manufacture comprising packaging and a composition comprising a cyclic analogue of histatin 5, wherein said packaging is labelled to indicate that the composition is suitable for treating a wound in a mammal (claim 18), which corresponds to the instantly claimed kit.
Response to Arguments
Applicant’s arguments filed on 6/9/2026 have been fully considered but they are not persuasive.
Applicant argues that “[L]ajoie does not describe a cyclized synthetic peptide comprising a disulfide bridge between two terminal cysteine residues and therefore fails to anticipate the synthetic peptide as claimed”.
Applicant’s arguments are not persuasive because, as discussed above, the cyclic analogue of Lajoie et al. comprises the sequence RHHCYKRFHEKCHSHRGY (SEQ ID No. 25) (claim 3), which corresponds to the instantly claimed peptide of formula (I).
Furthermore, Lajoie et al. teach that the cyclic histatin analogue comprises the sequence RHHGYKRFHEKHHSHRGY (SEQ ID No. 25) in which one or two of the amino acid residues is substituted with an amino acid selected from the group consisting of cysteine, glutamic acid, lysine and a thiol-containing amino acid to permit cyclization (para [0019]).
Therefore, the cyclic analogue RHHCYKRFHEKCHSHRGY forms a disulfide bridge between the two cysteine residues.
For the reasons stated above the rejection is maintained.
Conclusion
THIS ACTION IS MADE FINAL. 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 SERGIO COFFA whose telephone number is (571)270-3022. The examiner can normally be reached M-F: 6AM-4PM.
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/SERGIO COFFA Ph.D./
Primary Examiner
Art Unit 1658
/SERGIO COFFA/Primary Examiner, Art Unit 1658
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