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 .
CONTINUING DATA
This application is a 371 of PCT/EP2021/055109 03/02/2021
FOREIGN APPLICATIONS
UNITED KINGDOM 2003062.3 03/03/2020
This office action is in response to Applicant’s amendment submitted June 15, 2026. Claims 25 and 29-43 are pending.
The rejection of claim(s) 25 and 28-44 under 35 U.S.C. 103 as being unpatentable over Ventress in view of Lau and Migon is withdrawn. Applicant’s arguments are persuasive.
Claim Interpretation
Claims 25, 36, and 38 were amended to include new limitations b) and c). In order for the new limitations to find support in the specification as filed, the definition of SEQ ID NO: 2 and SEQ ID NO: 3 found on page 15 of the specification must be applied as the broadest reasonable interpretation of the claims. In this definition, @ is any amino acid capable of being stapled. The specification does not limit these amino acids or indicate that some amino acids are not capable of being stapled. For the purposes of examination, any amino acid is considered to be capable of being stapled since amino acids can be modified. The definition on page 15 does not require that the peptide is stapled or that it must contain a modification.
Page 26 of the specification provides a narrower definition of SEQ ID NO: 2 and SEQ ID NO: 3 wherein @ = [(S)-2-(4-pentenyl) alanine]; however, the broader definition on page 15 is the broadest reasonable interpretation of the claims as currently written.
The following new rejections were necessitated by Applicant’s amendment.
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 25 and 29-43 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 broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, each of claims 25, 36, and 38 recites the broad recitation “olefin-terminated modified amino acid residue,” and the claim also recites “optionally selected from” a narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. Claims 29-43 depend from claims 25, 36, or 38 and incorporate the same limitations by reference.
Claim Rejections - 35 USC § 102
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) 25, 29-35, and 43 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Alrahimi ((2018) The Role of Tetraspanins in Pseudomonas aeruginosa Adherence to Human Cells. PhD thesis, University of Sheffield, previously cited by the examiner).
Alrahimi teaches 800-Cap DEPQRETLKAIHYALN on page 42. DEPQRETLKAIHYALN is a peptide of SEQ ID NO:2 or SEQ ID NO:3 when @ is interpreted to be any amino acid. 800-Cap was used to reduce the percentage of cells infected by P. aeruginosa. Page 137. The limitation of claim 43 is an inherent property of the capped peptide due to the terminal aspartate residue and its ability to form stabilizing hydrogen bonds.
Claim Rejections - 35 USC § 103
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 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 25 and 29-43 is/are rejected under 35 U.S.C. 103 as being unpatentable over Alrahimi in view of Migon (The Protein Journal (2018) 37:2-12, cited on IDS).
Alrahimi teaches 800-Cap DEPQRETLKAIHYALN on page 42. DEPQRETLKAIHYALN is a peptide of SEQ ID NO:2 or SEQ ID NO:3 when @ is interpreted to be any amino acid. 800-Cap was used to reduce the percentage of cells infected by P. aeruginosa. Pages 137-138. 800-Cap is also very effective in reducing the adherence of S. aureus (page 146). The peptides are useful for treating bacterial infection (page 148). S. aureus colonizes the skin (page 11). P. aeruginosa causes infections in leg ulcers and burn wounds (page 150).
Alrahimi suggests but does not exemplify treatment of a subject.
Migon teaches that antimicrobial peptides are promising candidates for anti-infective pharmaceuticals and are applied topically.
It would have been obvious to one of ordinary skill in the art at the time the application was filed to use Cap-800 for treating a subject because Alrahimi suggests it. It would have been further obvious to administer the peptide along with an antimicrobial drug because the peptide is also useful for treating microbial infections. See MPEP 2144.06: “It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose…[T]he idea of combining them flows logically from their having been individually taught in the prior art.”
The limitation of claim 43 is an inherent property of the capped peptide due to the terminal aspartate residue and its ability to form stabilizing hydrogen bonds.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 LAYLA D BERRY whose telephone number is (571)272-9572. The examiner can normally be reached 7:00-3:00 CST, M-F.
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/LAYLA D BERRY/Primary Examiner, Art Unit 1693
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