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 .
Priority
This application was filed on and is a U.S. national Stage application under 35 U.S.C. 371 of International Patent Application No. PCT/KR2020/019459 filed 12/30/2020, which claims the benefit of the priority of Korean Patent Application No. 10-2020-0114698 filed 09/08/2020.
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Claim Status
Claims 2-11, 13-17, 19-20 are pending. Claims 11, 15-17 are withdrawn. Claims 1, 12, 18 are canceled. Claims 2-5, 9-10 are amended. Claims 2-10, 13-14, and 19-20 are being examined on the merits in this office action.
Claim Objections - Maintained
Claims 2-4 are objected to because of the following informalities:
Claim 2 should be amended to recite “….Formula 2 or Formula 3….” in line 2. Further, the claim should be amended to recite “…wherein, in Formula 2 or 3….”, in line 3.
Claim 3 should be amended to recite “…wherein Formula 2 is any….”, in line 3. The article “above” can be deleted. Claim 4 has a similar issue.
Appropriate correction is required.
Claim Rejections - 35 USC § 103 - Maintained
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 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 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.
Claims 2-10, 13-14, and 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Joon et al. (KR20140026275A – hereinafter “Joon”) in view of Gluckman et al. (WO2002016408A2 – hereinafter “Gluckman”) and Abajian et al. (US5767083A – hereinafter “Abajian”).
The teaching of the KR20140026275A publication are based on the English language translation of the KR20140026275A publication obtained by Espacenet and the citations are based on the English language translation.
Joon teaches a peptide for inhibiting collagenase activity having one amino acid sequence selected from the group consisting of GPN and PGN (claim 1; [0009]). Joon teaches a pharmaceutical composition, a health functional food composition, and a cosmetic composition comprising the peptides (claims 3-9).
Joon does not teach modifying the tripeptide wherein R1 is hydrogen, C1 -C6 alkyl group, C1 -C6 alkoxy group, palmitoyl group, lauroyl group, myristoyl group, stearoyl group, arachidoyl group or linoleoyl group, R2 is a hydroxy group, C1 -C6 alkyl group or C1 -C6 alkoxy group.
However, modifying peptides with the recited groups is known in the art as taught by Gluckman et al. Gluckman teaches GPE analogs wherein the Glu of Gly-Pro-Glu is replaced by amino acids including Asn (Abstract; claim 29). Examiner notes that replacing Glu of Gly-Pro-Glu with Asn results in the tripeptide Gly-Pro-Asn (GPN) which is the instant peptide. Gluckman teaches that the analog can be modified resulting in the analog GPE-stearate (claims 7). Examiner notes that in this case, R1 is hydrogen and R2 is a stearoyl group. Gluckman teaches pharmaceutical compositions comprising the analogs (claims 12-15). Gluckman teaches that the analog have a desirable bioactivity profile (page 4, line 1-28).
Further Abajian teaches tri-, tetra-, penta-, peptides modifications (Abstract), wherein the C terminus (R1) of the tri-, tetra-, or penta peptide is modified by groups such as hydrogen atom, a lower alkyl group, preferably having 1 to 3 carbon atoms, hydroxyl group and the R alkyl, or alkoxy groups (Col. 3, line 65-68).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the analog of Joon as taught by Gluckman so as to increase its bioactivity. Further, it would have been obvious to modify the tripeptide of Joon with the modifications taught by Abajain such as the addition of an alkyl group for better pharmacological activity. One of ordinary skill in the art would be motivated and would have had a reasonable expectation of success in modifying the peptide of Joon as taught by Gluckman since both references teach the same peptide and Gluckman teaches increased bioactivity with the modified peptide. Examiner notes that Joon teaches a peptide for inhibiting collagenase activity having one amino acid sequence selected from the group consisting of GPN and PGN (claim 1; [0009]). Further, Abajian teaches modifying tripeptides with wherein the C terminus (R1) of the peptide is modified by groups such as hydrogen atom, a lower alkyl group, preferably having 1 to 3 carbon atoms, hydroxyl group and the R alkyl, or alkoxy groups (Col. 3, line 65-68). It would have been obvious to modify the tripeptide of Joon with the modifications taught by Abajain such as the addition of an alkyl group for better pharmacological activity. The disclosures render obvious claim 2.
Regarding claim 3, Joon teaches a peptide for inhibiting collagenase activity having one amino acid sequence selected from the group consisting of GPN (claim 1; [0009]). Further, Abajian teaches modifying tripeptides with wherein the C terminus (R1) of the peptide is modified by groups such as hydrogen atom, a lower alkyl group, preferably having 1 to 3 carbon atoms, hydroxyl group and the R alkyl, or alkoxy groups (Col. 3, line 65-68). It would have been obvious to modify the tripeptide of Joon with the modifications taught by Abajain such as the addition of an alkyl group for better pharmacological activity. Examiner notes modifying the peptide of Joon with H and an alkyl group, a hydroxyl group or alkoxy group would read on the derivatives of Formula 4 to 8.
Regarding claim 4, Joon teaches a peptide for inhibiting collagenase activity having one amino acid sequence selected from the group consisting of PGN (claim 1; [0009]). Further, Abajian teaches modifying tripeptides with wherein the C terminus (R1) of the peptide is modified by groups such as hydrogen atom, a lower alkyl group, preferably having 1 to 3 carbon atoms, hydroxyl group and the R alkyl, or alkoxy groups (Col. 3, line 65-68). It would have been obvious to modify the tripeptide of Joon with the modifications taught by Abajain such as the addition of an alkyl group for better pharmacological activity. Examiner notes modifying the peptide of Joon with H and an alkyl group, a hydroxyl group or alkoxy group would read on the derivatives of Formula 9 to 13.
Regarding claim 5, Joon teaches a cosmetic composition comprising the peptides, that the cosmetic composition is for wrinkle improvement, and for skin regeneration (claims 7-9; [0001).
Regarding claims 6-8, Joon teaches a cosmetic composition comprising the peptides, that the cosmetic composition is for wrinkle improvement, and for skin regeneration (claims 7-9; [0001) and for inhibiting collagenase activity [0009]. Further, Examiner notes that prior art references teach the instant peptides and teaches modifying the N and C terminus as recited in the instant claims. Joon teaches the instant peptides used as cosmetic composition to for wrinkle improvement, and for skin regeneration (claims 7-9; [0001) and for inhibiting collagenase activity [0009, 0117, 0119, 0128-0130]. Examiner concludes that the prior art structure inherently possesses the functionally defined limitations of the claimed composition.
Regarding claims 9-10, Joon teaches a pharmaceutical composition, and a health functional food composition, comprising the peptides (claims 3-9) and that the composition has the effect of inhibiting the activity of collagenase [0001, 0006-0009, 0024-0025, 0028, 0053, 0078].
Regarding claims 13-14, Joon teaches a peptide for inhibiting collagenase activity having one amino acid sequence selected from the group consisting of GPN and PGN (claim 1; [0009]). Further, Abajian teaches modifying tripeptides with wherein the C terminus (R1) of the peptide is modified by groups such as hydrogen atom, a lower alkyl group, preferably having 1 to 3 carbon atoms, hydroxyl group and the R alkyl, or alkoxy groups (Col. 3, line 65-68). It would have been obvious to modify the tripeptide of Joon with the modifications taught by Abajain such as the addition of an alkyl group for better pharmacological activity. Examiner notes modifying the peptide of Joon with H and an alkyl group, a hydroxyl group or alkoxy group would read on the derivatives of Formula 4 to 13. Further, Joon teaches a cosmetic composition comprising the peptides, that the cosmetic composition is for wrinkle improvement, and for skin regeneration (claims 7-9; [0001) and for inhibiting collagenase activity [0009].
Regarding claims 19-20, Joon teaches a peptide for inhibiting collagenase activity having one amino acid sequence selected from the group consisting of GPN and PGN (claim 1; [0009]). Further, Abajian teaches modifying tripeptides with wherein the C terminus (R1) of the peptide is modified by groups such as hydrogen atom, a lower alkyl group, preferably having 1 to 3 carbon atoms, hydroxyl group and the R alkyl, or alkoxy groups (Col. 3, line 65-68). It would have been obvious to modify the tripeptide of Joon with the modifications taught by Abajain such as the addition of an alkyl group for better pharmacological activity. Examiner notes modifying the peptide of Joon with H and an alkyl group, a hydroxyl group or alkoxy group would read on the derivatives of Formula 4 to 13. Further, Joon teaches a cosmetic composition comprising the peptides, that the cosmetic composition is for wrinkle improvement, and for skin regeneration (claims 7-9; [0001) and for inhibiting collagenase activity [0009]. Further, Joon teaches a health functional food composition, comprising the peptides (claims 3-9) and that the composition has the effect of inhibiting the activity of collagenase [0001, 0006-0009, 0024-0025, 0028, 0053, 0078].
Response to Arguments
Applicant's arguments filed 04/01/2026 have been fully considered but they are not persuasive.
Applicant Arguments
Applicant argues that Joon fails to disclose a critical feature of the present claims, namely peptide derivatives having specific terminal modifications. Applicant further argues that Gluckman and Abajian are directed to entirely different peptides and that the difference in amino acid composition is not trivial, as even a single amino acid substitution in short peptides significantly alters biological activity, stability, and interaction with enzymes. Applicant argues that there is no teaching, suggestion, or motivation to combine these references with Joon. Applicant argues that the instant invention having specific modifications at the N-terminus and/or C-terminus of a peptide exhibit improved activity over the unmodified peptide itself. Applicant argues that prior art does not establish that the claimed modified peptides inherently possess the claimed activity (Page 7-9 of Arguments).
Examiner’s Response
The arguments presented above have been fully considered but are unpersuasive. Examiner notes that the instant peptides are known in the art as taught by Joon and Joon teaches that the peptides are in a pharmaceutical composition, a health functional food composition, and a cosmetic composition for use for inhibiting collagenase activity. Examiner further notes that modification of small peptides is known in the art and is extensively known to protect the peptide from enzymatic degradation stabilizing the peptide. Additionally, Gluckman teaches the instant peptide modified and the N and C terminus. Specifically, Gluckman teaches GPE analogs wherein the Glu of Gly-Pro-Glu is replaced by amino acids including Asn (Abstract; claim 29). Examiner notes that replacing Glu of Gly-Pro-Glu with Asn results in the tripeptide Gly-Pro-Asn (GPN) which is the instant peptide. Gluckman teaches that the analog can be modified resulting in the analog GPE-stearate (claims 7). Gluckman teaches that the analog have a desirable bioactivity profile (page 4, line 1-28). Further Abajian teaches tri-, tetra-, penta-, peptides modifications (Abstract), wherein the C terminus (R1) of the tri-, tetra-, or penta peptide is modified by groups such as hydrogen atom, a lower alkyl group, preferably having 1 to 3 carbon atoms, hydroxyl group and the R alkyl, or alkoxy groups (Col. 3, line 65-68). Modification of tripeptides at the N and C terminus is thus known in the art and it is known that such modification has an added advantage of stability and improved biological activity. Examiner used the Gluckman and the Abajian reference to teach that modification of tripeptides is known in the art. In fact, Gluckman indeed teaches that instant peptide GPN and teaches N and C terminal modification. Examiner notes that the instant invention is drawn to a specific peptide that is modified at the N and C terminus. The primary reference teaches the instant peptide and teaches that the peptides possess the instant biological activities. Thus applicant assertion that prior art does not establish that the claimed modified peptides inherently possess the claimed activity is unpersuasive. Additionally, Gluckman teaches the instant peptide modified at the N and C terminus as instantly claimed. Abajian teaches N and C terminal modification of tripeptides.
Examiner notes that the obviousness rejection is based on the combined teachings of Joon, Gluckman and Abajian. Thus, in response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). The test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981). One of ordinary skill in the art who has read the cited references would arrive to the instant invention since, there is a motivation to modify the N and C terminus of tripeptides of Joon for enhanced biological activity. Such tripeptides modifications are known in the art as taught by Gluckman and Abajian. Obviousness does not require absolute predictability, only a reasonable expectation of success, i.e., a reasonable expectation of obtaining similar properties. See, e.g., In re O’Farrell, 853 F.2d 894, 903, 7 USPQ2d 1673, 1681 (Fed. Cir. 1988). (MPEP 2144.08 (II). The arguments are unpersuasive.
Conclusion
No claims are allowed.
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 Mercy H. Sabila whose telephone number is (571)272-2562. The examiner can normally be reached Monday - Friday 5:00 am - 3:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Lianko G. Garyu can be reached at (571)270-7367. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MERCY H SABILA/Examiner, Art Unit 1654
/LIANKO G GARYU/Supervisory Patent Examiner, Art Unit 1654
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