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
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 12/22/2025 has been entered.
Claim Status
Claims 31-43 are pending. Claims 42-43 have been added. Claims 1, 26 and 29-30 have been canceled. Claims 31-41 have been amended. Claims 31-32, 37, 40 and 42-43 are being examined in this application. In the response to the restriction requirement, Applicants Group I and PEP-23 (Ac-L-Arg-L-Arg-L-Gln-D-Met-L-Glu-L-Glu-NH2). Claims 33-36, 38-39 and 41 are withdrawn as being drawn to a nonelected species/invention.
Response to Amendment
The declaration under 37 CFR 1.132 filed on 12/22/2025 is insufficient to overcome the rejection of claims 31-32, 37, 40 and 42-43 based upon 35 U.S.C. 103 as set forth in the last Office action.
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Applicant argues that the compounds of claim 31 significantly improve MBLN1 upregulation, as shown in the table depicted below.
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Applicant also argues that Fasel does not teach or suggest including one or two D-enantiomeric amino acids at the AA3 and/or AA4 positions in a peptide otherwise composed of L-enantiomeric amino acids would upregulate MBLN1, and further argues that these results would not be expected.
Applicant’s arguments have been fully considered but they are not persuasive.
With respect to Applicant’s alleged unexpected results, the MPEP 716.02(b) states that “[T]he evidence relied upon should establish "that the differences in results are in fact unexpected and unobvious and of both statistical and practical significance." Ex parte Gelles, 22 USPQ2d 1318, 1319 (Bd. Pat. App. & Inter. 1992) (Mere conclusions in appellants’ brief that the claimed polymer had an unexpectedly increased impact strength "are not entitled to the weight of conclusions accompanying the evidence, either in the specification or in a declaration."); Ex parte C, 27 USPQ2d 1492 (Bd. Pat. App. & Inter. 1992) (Applicant alleged unexpected results with regard to the claimed soybean plant, however there was no basis for judging the practical significance of data with regard to maturity date, flowering date, flower color, or height of the plant.). See also In re Nolan, 553 F.2d 1261, 1267, 193 USPQ 641, 645 (CCPA 1977) and In re Eli Lilly, 902 F.2d 943, 14 USPQ2d 1741 (Fed. Cir. 1990) as discussed in MPEP § 716.02(c).
In the instant case, the data presented in the Table above show that Argireline at 0.5 mg/ml does not significantly upregulate MBLN1. However, Argireline at 1 mg/ml significantly upregulate MBLN1.
Even assuming arguendo that the upregulation of MBLN1 by the claimed compounds is unexpected (which the Examiner does not concede), it is clear that not all claimed compounds significantly upregulate MBLN1. For instance, PEP-36 (which corresponds to instant SEQ ID NO: 30) does not significantly upregulate MBLN1 (see Table above).
Furthermore, in contrary to Applicant’s arguments, Fasel et al. teach that the peptides comprise a mixture of L or D enantiomers of the desired amino acids (claim 4), and further teach that D-amino acid peptides could be applied to other peptides such as Argireline (acetyl-hexapeptide) (para [0058]).
The skilled artisan would have been motivated, with a reasonable expectation of success, to make a retro-inverso peptide wherein one L-amino acid at the time is substituted with the corresponding D-amino acid, thus arriving at the claimed compound PEP-23 (Ac-L-Arg-L-Arg-L-Gln-D-Met-L-Glu-L-Glu-NH2).
In view of the foregoing, when all of the evidence is considered, the totality of the rebuttal evidence of nonobviousness fails to outweigh the evidence of obviousness.
Claim Rejections - 35 USC § 103
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 rejection has been modified.
Claims 1, 26, 29-32, 37 and 40 are rejected under 35 U.S.C. 103 as being unpatentable over Fasel et al. (WO 2007/071448).
With respect to claim 31, Fasel et al. teach a composition comprising one or more peptides wherein the peptide or peptides consists essentially of an amino acid sequence set out in SEQ ID NO: 1-23 (claim 1), wherein the peptides comprise L-enantiomers of the desired amino acids (claim 2), wherein the peptides comprise D-enantiomers of the desired amino acids (claim 3), and wherein the peptides comprise a mixture of L or D enantiomers of the desired amino acids (claim 4).
Fasel et al. also teach that “[I]n a related embodiment the compositions comprise one or more of SEQ ID NO: 24-29” (para [0022]), and further teach that “[I]n a further aspect, the present invention provides a peptide composition as set out above wherein the peptides comprise L-enantiomers of the desired amino acids or D-enantiomers of the amino acids, or a mixture of L- or D-enantiomers of the desired amino acids. In a related aspect, the invention contemplates that the peptide compositions may be, or may further comprise, one or more retro-inverso isomers of one or more of the peptides set out in SEQ ID NOs: 1-23 (para [0023]).
Fasel et al. further teach that D-amino acid peptides (direct sequence or retroinverso) could be applied to other peptides such as Argireline (acetyl-hexapeptide) (para [0058]).
Fasel et al. additionally teach that Argireline acetyl has the following sequence Ac-Glu-Glu-Met-Gln-Arg-Arg-NH2 (SEQ ID NO: 24) (para [0013]).
Fasel et al. do not specifically teach the claimed compounds (i.e. retro-inverso peptide wherein one or two L-amino acids are substituted with the corresponding D-amino acid).
It would have been obvious to one of ordinary skill in the art to make a retro-inverso peptide wherein one L-amino acid at the time is substituted with the corresponding D-amino acid. Given the finite possibilities, the skilled artisan would have arrived at the claimed compounds of SEQ ID NOs: 22, 35 and 38.
The skilled artisan would have had a reasonable expectation of success because Fasel et al. teach that retro-inverso peptides such as Argireline (acetyl-hexapeptide) can comprise a mixture of L or D enantiomers of the desired amino acids.
With respect to claims 32, 37, 40 and 42-43, the compounds obvious over Fasel et al. correspond to the compounds PEP-22, PEP-23 and PEP-24 (SEQ ID NOs: 22,35 and 38 respectively), wherein R1 is acetyl and R2 is NH2.
Response to Arguments
Applicant’s arguments filed on 12/22/2025 have been fully considered but they are not persuasive.
Applicant argues that claims 1-4 of Fasel, referenced in the Office Action, refer to SEQ ID NO: 1- 23, not to the ARGIRELINE® peptide.
Applicant also argues that “[D]-amino acid substitutions to the sequences of SEQ ID NO: 1-23 would not lead a person of ordinary skill in the art to the sequences claimed in the instant application. The Office appears to understand and accept this, requiring modifications to the sequence of the ARGIRELINE® peptide instead. However, contrary to the Office Action, nothing in Fasel would suggest or motivate one of ordinary skill in the art to apply the strategy of claims 1- 4 to the ARGIRELINE® peptide sequence”.
Applicant’s arguments are not persuasive.
Applicant’s arguments regarding unexpected results have been discussed above under “Response to Amendment” on pages 2-5.
Fasel et al. teach that “[I]n a related embodiment the compositions comprise one or more of SEQ ID NO: 24-29” (para [0022]), and further teach that “[I]n a further aspect, the present invention provides a peptide composition as set out above wherein the peptides comprise L-enantiomers of the desired amino acids or D-enantiomers of the amino acids, or a mixture of L- or D-enantiomers of the desired amino acids. In a related aspect, the invention contemplates that the peptide compositions may be, or may further comprise, one or more retro-inverso isomers of one or more of the peptides set out in SEQ ID NOs: 1-23 (para [0023]).
Thus, it is clear that the teachings of Fasel et al. do NOT exclude the Argireline peptide sequence.
Given the teachings of Fasel et al., one of ordinary skill in the art would have been motivated, with a reasonable expectation of success, to make a retro-inverso peptide wherein one L-amino acid at the time is substituted with the corresponding D-amino acid. Given the finite possibilities, the skilled artisan would have arrived at the claimed compounds of SEQ ID NOs: 22, 35 and 38.
For the reasons stated above the rejection is maintained.
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