DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Status of the Application
The amendment and remarks of 4 December 2025 are entered.
The election requirement remains in effect.
Claims 1-17 are pending. Claims 4-17 are withdrawn without traverse. Claims 1-3 are being examined on the merits.
The rejection of claims 1-3 under 35 U.S.C. 103 as being unpatentable over ‘620 is modified in light of the Applicant’s amendment filed 4 December 2025.
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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claims 1-3 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Szeto et al. (USP 7,718,620 B2, published 18 May 2010, filed 30 June 2006, hereafter referred to as ‘620).
The ‘620 patent describes a genus of aromatic-cationic peptides of at least 4 amino acids in length (see e.g. Col.2 lines 19-25 and Col.5 lines 29-32). The peptides may contain substitutions on the rings of Phe or Tyr residues (see e.g. Col.6 lines 30-33). The genus includes peptides with combinations of L- and D- amino acids to provide protection against digestion by proteases (see e.g. Col.5 line 65 to Col.6 line 9, Col.6 line 62 to Col.7 line 6, Col.7 lines 7-15, and Col.6 line 61). The genus includes peptides that are amidated at the C-terminus (see e.g. Col.9 lines 39-41). A specific peptide SS-31 having a sequence D-Arg-2’,6’-Dmt-Lys-Phe-NH2 is disclosed (see e.g. Col.12 lines 35-38). The ‘620 patent discloses pharmaceutical formulations with a carrier (see e.g. Col.19 lines 49-60).
The difference between ‘620 and the claimed invention is that ‘620 does not explicitly disclose D-Arg-Dmt-D-Lys-Phe-NH2 or D-Arg-Dmt-Lys-D-Phe-NH2.
It would have been obvious to one of ordinary skill in the art at the time of invention to utilize the disclosure of ‘620 to prepare variants of the SS-31 peptide D-Arg-Dmt-D-Lys-Phe-NH2 or D-Arg-Dmt-Lys-D-Phe-NH2. Since ‘620 suggests using D-amino acids to prevent digestion by native proteases, the skilled artisan would have extended introduction of D-amino acids along the peptide chain to provide increased protection against proteolysis, and in doing so readily produce all variants of D-Arg-Dmt-Lys-Phe-NH2 through minimal experimentation. The skilled artisan in this case has a high level of skill and is only required to introduce additional D-amino acids, which ‘620 provides a motivation for utilizing in avoiding protease digestion. There would have been a reasonable expectation of success because the skilled artisan has to make a single L to D substitution in SS-31 and ‘620 offers guidance on doing so in preparing variants of SS-31. The invention would have been prima facie obvious to one of ordinary skill in the art at the time of invention.
With respect to claims 2 and 3, as set forth above ‘620 provides for pharmaceutical compositions with a carrier.
Response to Arguments:
The Applicants argue the Examiner bears the burden of establishing obviousness and that a reason for combining prior art elements must be provided. The Applicants argue the claims are amended to recite only two peptides, D-Arg-Dmt-D-Lys-Phe-NH2 and D-Arg-Dmt-Lys-D-Phe-NH2.
The Examiner agrees that the burden lies with the Office to establish obviousness, which has been provided. The ‘620 art provides a nearly identical peptide in the form of SS-31, D-Arg-Dmt-Lys-Phe-NH2. “620 also suggests introduction of D-amino acids. This reasonably leads to the skilled artisan to prepare all further variants of SS-31. This only requires introducing D-amino acids at 1-3 positions. A stepwise evaluation of SS-31 and further introduction of D-amino acids reasonably leads to both of the claimed aromatic cationic peptides now found in the amended claims.
The Applicants summarize the previous rejection, and argues ‘620 does not teach D-Arg-Tyr-Lys-Phe-NH2 or D-Arg-Dmt-Lys-D-Phe-NH2. The Applicants recite the Examiner’s obviousness analysis.
The Examiner agrees that ‘620 does not explicitly teach either peptide. As noted by the Applicants previously, the D-Arg-Tyr-Lys-Phe-NH2 peptide is no longer claimed. The Examiner notes that the obviousness analysis is altered by the Applicants’ amendment.
The Applicants argue the Examiner asserts the alteration could be done merely because it would have been easy to do so, and that this is insufficient per MPEP 2141 and KSR.
The Examiner disagrees. The ‘620 art provides both the base, nearly identical peptide in SS-31. ‘620 also explicitly discusses introduction of D-amino acids to avoid proteases. This alone provides the rationale for one of ordinary skill to prepare the peptides. The ease of preparation is merely reflective of the fact that three positions are available out of four for further D-amino acids, which is readily handled through standard synthetic techniques for production of short peptides.
The Applicants argue ‘620 does not teach the claimed peptides and the Examiner has not offered sufficient motivation to modify ‘620.
The Examiner disagrees for the reasons above. ‘620 provides a nearly identical peptide and previously discusses introduction of D-amino acids. This offers a rationale to modify the SS-31 peptide through standard peptide synthesis techniques.
The Applicants’ arguments have been considered but are not persuasive. The rejection is modified in light of Applicants’ amendment and maintained.
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 ZACHARY J MIKNIS whose telephone number is (571)272-7008. The examiner can normally be reached M-F 9-5.
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/Z.J.M/Patent Examiner, Art Unit 1658
/SUDHAKAR KATAKAM/Primary Examiner, Art Unit 1658
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