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 31-43 are pending. Claims 31-32 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 Claims 33-36, 38-39 and 41 are withdrawn as being drawn to a nonelected species/invention.
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 is maintained.
Claims 31-32, 37 40 and 42-43 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 6/11/2026 have been fully considered but they are not persuasive.
Applicant argues that “[U]nexpectedly, the Claimed Compounds Increased MBLN1 Expression when the ARGIRELINE® Peptide Decreased MBLN1 Expression”.
Applicant also argues that “[T]he Unexpected Increase in MBLN1 Expression Causes Beneficial Practical Effects in Facial Appearance”.
Applicant further argues that “[T]he Claims Have Been Narrowed to the Compounds that Show Significant Increases in MBLN1 Expression”.
Applicant additionally argues that “[F]asel Does Not Establish a Prima Facie Case of Obviousness”.
Applicant’s arguments are not persuasive.
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).
Furthermore, the MPEP 716.02(e) states that the claimed invention must be compared to the closest prior art, and the MPEP 716.02(d) states that unexpected results must be commensurate in scope with the claimed invention.
To be able to claim unexpected results, Applicants should compare the claimed peptides at 1 mg/ml with Argireline at 1 mg/ml.
Note that the data presented in the Table below show that Argireline at 0.5 mg/ml does not significantly decrease MBLN1 expression. However, Argireline at 1 mg/ml, just like the claimed peptides, significantly decreases MBLN1 expression.
It is clear that there is no difference between Argireline at 1 mg/ml and the claimed peptides at 1 mg/ml concentration.
Therefore, to claim unexpected results, the claims should be amended to define that the concentration is 0.5 mg/ml.
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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).
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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