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 .
Receipt is acknowledged for preliminary amendment and IDS filed 04/17/2023.
Claims 3-4 and 6-14 are amended,
Claims 1-14 are pending.
Priority
This application is a 371 of PCT/EP2021/078819 filed 10/18/2021 and which claims benefit of French application 2010784 filed 10/21/2020.
Information Disclosure Statement
The IDS filed 04/17/2023 has been considered by the examiner.
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 1-14 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.
Claims 1-14 recite use of peptide without reciting any steps. Thus, claims 1-14 attempting to claim process without setting forth any steps involved in the process raises indefiniteness issue. It is not clear if the claims intend to teach process of treating hair by applying composition comprising peptide of formula 1:-(Xaa)n-P*P*-(Xaa)m-Z to hair follicle or method of treating depigmentation by applying composition comprising peptide of formula 1:-(Xaa)n-P*P*-(Xaa)m-Z or composition comprising peptide of formula 1:-(Xaa)n-P*P*-(Xaa)m-Z for cosmetic non-therapeutic hair treatment adapted to prevent hair pigmentation.
The claims are examined as method of non-therapeutic hair treatment, the method comprising applying to hair at least one peptide of formula 1; X-(Xaa)n-P*P*-(Xaa)m-Z, where m+n is < 8 with m, n being 0, 1, 2, 3 or 4. While the claims do not recite process steps, the claims are examined as applying the claimed peptide to hair to prevent hair depigmentation. Pro-pigmenting or pigmenting or pro-pigmenting activity reads or preventing depigmentation,
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-14 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) does/do not fall within at least one of the four categories of patent eligible subject matter because claims 1-14 are use claims and do not purport to claim a process, machine, manufacture, or composition of matter and thus fail to comply with 35 U.S.C. 101. See In re Moreton, 288 F.2d 708, 709, 129 USPQ 227, 228 (CCPA 1961), In Ex parte Dunki, 153 USPQ 678 (Bd. App. 1967).
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1 and 4-14 is/are rejected under 35 U.S.C. 102(1)(1) and 102(a)(2) as being anticipated by Peschard et al, (US 9534015 B2).
Peschard discloses the following peptides: X-PPR-Y (column 6, line 19), X-PPM-Y, X-PPG-Y, X-PPS-Y, X-PPG-Y, X-PPS-Y, X-PPR-Y (column 7, lines 26, 33, 39), Pal-PPR-OH, Pal-PPA-OH, (Table bridging columns 13 and 14; column 15, Item 2); these peptides have pro-pigmenting activity (column 6, lines 11-19, column 7, lines 55-56, 58, 60, 64-65); the peptides are applied to face, body, neck, scalp, hair and body hair in forms such as microcapsules or nanoparticles, macrosponges, microsponges, nanosponges, microemulsions or nanoemulsions, talcs, bentonites (column 8, lines 56-67; column 9, lines 1-14). The method of Peschard is suitable for pro-pigmenting treatment to prevent or treat the loss of pigmentation (column 12, lines 22-39).
In peptide, X-PPR-Y, n is zero and m is 1 as (Xaa)m is R or Arginine, Y which meets the limitation of Z is OH, OR1, NH2, NHR or NR1R2 and X is -CO-R1, SO2-R1 (column 6, lines 61-67). In all the peptides listed above, n is zero and m is 1 making m+n to be 1 which is less than 8.
Thus, for claims 1, 4 and 5, application of the peptides X-PPR-Y (column 6, line 19), X-PPM-Y, X-PPG-Y, X-PPS-Y, X-PPG-Y, X-PPS-Y, X-PPR-Y (column 7, lines 26, 33, 39), Pal-PPR-OH, Pal-PPA-OH to hair for pro-pigmenting treatment to prevent or treat the loss of pigmentation (column 12, lines 22-39; claims 1 and 17) anticipates the claims.
For claim 6, the peptide composition is topically applied (column 8, lines 23, 36; column 9, line 14; column 11, lines 37, 40, 44; claims 1, 17, 23).
For claim 7, Proline (P) is p* (see at least peptides X-PPR-Y (column 6, line 19), X-PPM-Y, X-PPG-Y, X-PPS-Y, X-PPG-Y, X-PPS-Y, X-PPR-Y (column 7, lines 26, 33, 39), Pal-PPR-OH, Pal-PPA-OH, (Table bridging columns 13 and 14; column 15, Item 2).
For claim 8, in at least peptide X-PPS-Y, n =0 and m=1.
For claims 9, 10 and 11, Pal in Pal-PPR-OH and Pal-PPA-OH is palmitoyl representing modification at the N-terminal (claim 9), and palmitoyl is a C16 meeting claims 10 and 11.
For claim 12, Y which is Z is OH, OMe, OEt and NH2, and X is -CO-R1, (claim 12, column 7, lines 43-54).
For claim 13, Pal-PP-OH (column 7, line 62; table bridging columns 13 and 14; claim 16
For claim 14, the form of the peptide composition in forms such as microcapsules or nanoparticles, macrosponges, microsponges, nanosponges, microemulsions or nanoemulsions, talcs, bentonites (column 8, lines 56-67; column 9, lines 1-14) have the peptides within those carrier vehicles.
Therefore, Peschard teaches all the elements of claims 1 and 4-14.
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) 1 and 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Peschard et al, (US 9534015 B2) in view of Marlon R. Schneider et al., “The Hair Follicle as a Dynamic Miniorgan” in Current Biology, 19, February 2009.
Claim 2 depends from claim 1.
Peschard has been described above to teach claim 1.
Peschard teaches applying its peptide composition to hair (column 8, lines 56-67; column 9, lines 1-14). For claim 2, Peschard does not link hair follicle to the hair. However, it is known in the art that melanocyte progenitors give rise to hair follicle pigmentary (page R132, paragraph bridging left and right columns) and melanin is produced in hair follicle melanocytes (R139, 3rd and 4th full paragraphs of Schneider); hair shaft consists of differentiated keratinocytes that are produced by the hair follicle (abstract). Antioxidizing treatment of the melanocytes present in the hair follicle is the effect of the applied peptide. Therefore, before the effective date of the invention, the artisan would reasonably expect that applying the peptide of the clams to hair would predictably inherently produce antioxidizing effect.
Peschard in view of Marlon R. Schneider renders claim 2 prima facie obvious.
Claim(s) 1 and 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Peschard et al, (US 9534015 B2) in view of Marina Tsatmali et al., “Melanocyte Function and Its Melanocortin Peptide” in The Journal of Histochemistry and Cytochemistry, Vol 30(2): 125-133, 2002.
Claim 3 depends from claim 1.
Peschard has been described above to teach claim 1.
Peschard teaches applying its peptide composition to hair (column 8, lines 56-67; column 9, lines 1-14). For claim 3, Peschard does not teach transfer of melanin to the keratinocytes by the dendrites. However, Marina Tsatmali teaches that melanocytes cells are associated with keratinocytes via their dendrites (see the whole document with emphasis on the SUMMARY). Therefore, before the effective date of the invention, he artisan would reasonably expect that applying the peptide of the clams to hair would predictably inherently promote the transfer of melanin to the keratinocytes by the dendrites.
Thus, Peschard in view of Marina Tsatmali renders claim 3 prima facie obvious.
Double Patenting
The non-statutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A non-statutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on non-statutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a non-statutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-14 are rejected on the ground of non-statutory double patenting as being unpatentable over claims 1-16; 1-11 and 13-15; and 1-24 of U.S. Patent Nos. 10231917 B2; 10668000 B2; and 9534015 B2 respectively. Although the claims at issue are not identical, they are not patentably distinct from each other because:
US 10231917 B2: The tripeptide of issued claims 1-6 where the tripeptide is for example Pal-PPA-OH having Xaa1 as Pro with n=1 and Alanine (A) as Xaa2 is used the claimed method and cosmetic method of improving skin condition renders the claimed method prima facie obvious because skin is endowed with hair.
US 10668000 B2: The topical composition in issued claims 1-11 is used in the examined method and the composition used in the method of issued claims 13-15 is also used in the examined method.
US 9534015 B2: The peptide containing composition used in the issued method of cosmetically pigmenting skin in issued claims 1-24 is the composition used in the claimed method.
The following prior art made of record and considered pertinent to applicant's disclosure:
Peschard et al. (US 20200253852 A1) discloses peptides of general formula X-(Xaa1)n-Pro*-(Xaa2)m-Y that have pro-pigmenting and pigmenting enhancing activity that are useful for preventing depigmentation and enhancing re-pigmenting of hair and have potent effects on melanocyte pigmentation; some specific peptides are Pal-PP-OH, Pal-PPR-OH, Pal-PPA-OH (See the whole document with emphasis on paragraphs [0003]-[0008], [0012], [0031]-[0040], [0065]-[0092], [0101]-[0107], [0115]-[0116], [0128], [0129], [0136], [0146], [0164], [0202], and claims 1-11)
No claim is allowed.
The specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BLESSING M FUBARA whose telephone number is (571)272-0594. The examiner can normally be reached 7:30 am-6 pm (M-T).
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/BLESSING M FUBARA/Primary Examiner, Art Unit 1613