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 .
Applicants' arguments, filed 07/15/2026, have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Claim Rejections - 35 USC § 102/103--Previous
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.
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.
Claim(s) 1-14 remain rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Giulani et al., (WO 2014/125452, cited in IDS).
Giulani et al. teaches “use of formula (I) R-N1-spermidine, or 1,4-butandiamin,N-(3-aminopropyl)-N1-R, (I) H2N – (CH2)3 – N1(R) – (CH2)4 – NH2 either as such or in the form of a pharmaceutically acceptable derivative” in a “cosmetic composition designed to promote hair pigmentation, particularly the pigmentation of the shaft” . . . “for topical administration” (Abstract), where R can be “methyl”, “cycloalkyl groups formed by 3 to 8 atoms of carbon”, e.g., cyclohexyl, “ethyl”, “propyl”, or “isobutyl”, as per claims 1-6. (see p. 3, lines 15-32; see also table at p. 17).
“A preferred compound with formula (I) for this invention is N1-methyl-spermidine or N-(3-amino propyl)-N1-methyl-1,4-butandiamine” (p. 4, lines 24-26).
The compositions use an aqueous carrier, i.e. “Aqua” (p. 6, Example 1, Hair Gel), which suffices as a cosmetically acceptable carrier, as per claims 8, and 13.
“Suitable forms for topical use include, for example, a lotion, a conditioner, a shampoo, a mask or a gel” (p. 4, lines 17-18). Since these forms are not necessarily limited to application of the scalp, it would have been expected to apply these forms to other parts of the body comprising hair, such as the face, as per claims 7, 9-12 and14.
The prior art also teaches direct application to hair follicles in a hair pigmentation study using N-methyl-spermidine (p. 11, lines 10-16), where results showed “the increase in melanin produced in case of treatment with N-methyl-spermidine at both concentrations tested in a dose dependent manner” (see p. 12, lines 20-24).
The prior art is anticipatory insofar as it teaches applying compounds of formula (I), e.g. N1-methy-spermidine, to the hair of a subject, which would have included the cuticle and shaft.
Assuming, purely arguendo, the that prior art does not provide sufficient specificity to give rise to anticipation, it would have been obvious to a person having ordinary skill in the art at the time of applicant’s filing to administer a compound of formula (I) to the hair (shaft/cuticle) of a subject motivated by the desire to promote hair pigmentation, as taught by Giulani et al.
Claim Rejections - 35 USC § 103--Previous
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) 1-14 remain rejected under 35 U.S.C. 103 as being unpatentable over Giulani et al., (WO 2014/125452) in view of Kasukabe et al., (JP2007291027).
Giulani et al. teaches “use of formula (I) R-N1-spermidine, or 1,4-butandiamin,N-(3-aminopropyl)-N1-R, (I) H2N – (CH2)3 – N1(R) – (CH2)4 – NH2 either as such or in the form of a pharmaceutically acceptable derivative” in a “cosmetic composition designed to promote hair pigmentation, particularly the pigmentation of the shaft” . . . “for topical administration” (Abstract), where R can be “methyl”, “cycloalkyl groups formed by 3 to 8 atoms of carbon”, e.g., cyclohexyl, “ethyl”, “propyl”, or “isobutyl”, as per claims 1-6. (see p. 3, lines 15-32; see also table at p. 17).
“A preferred compound with formula (I) for this invention is N1-methyl-spermidine or N-(3-amino propyl)-N1-methyl-1,4-butandiamine” (p. 4, lines 24-26).
“Suitable forms for topical use include, for example, a lotion, a conditioner, a shampoo, a mask or a gel” (p. 4, lines 17-18). Since these forms are not necessarily limited to application of the scalp, it would have been reasonable to apply these forms to other parts of the body comprising hair, such as the face, as per claims 7, 9-12 and14.
The compositions use an aqueous carrier, i.e. “Aqua” (p. 6, Example 1, Hair Gel), which suffices as a cosmetically acceptable carrier, as per claims 8, and 13.
The prior art also teaches direct application to hair follicles in a hair pigmentation study using N-methyl-spermidine (p. 11, lines 10-16), where results showed “the increase in melanin produced in case of treatment with N-methyl-spermidine at both concentrations tested in a dose dependent manner” (p. 12, lines 20-24).
The prior art differs from the instant claims insofar as it does not teach application to the eyelashes and/or eyebrows.
Kasukabe et al. teaches “a method for preparing a polyamine or a polyamine composition . . . utilized for health, cosmetics, foods and medicines” (Abstract)
Typical polyamines include “spermidine and spermine” (p. 3, para. 8), where specific examples of cosmetics include “lotions”, “shampoos” (p. 6, 3rd paragraph), “Hair conditioner, rinse, hair treatment, hair cream, pomade, hair spray, hair styling, perm, hair nick, hair dye, hair restoration, hair restoration, hair restoration, foundation, white powder, funny, lipstick, blush, eye Makeup cosmetics such as shadows, eyeliner, mascara, eyebrows, and eyelashes” (Id.).
It would have been obvious to formulate a composition of Giulani et al. for application to the eyelashes and eyebrows since the compositions include cosmetics, generally, wherein suitable forms to a person having ordinary skill in the art would have reasonably included cosmetics for the eyebrows and eyelashes, as taught by Kasukabe et al. The artisan would have had a reasonable expectation of success with the combination insofar as the cosmetics of Kasukabe et al. include spermidine.
Technological Background
1) The prior art made of record and considered pertinent to applicant's disclosure Ramet et al., (Plos One). Ramet et al. is pertinent for teaching that spermidine promotes hair growth. “Specifically, we demonstrate that spermidine stimulates hair shaft elongation, accompanied by prolongation of anagen, and thus directly promotes human HF growth. This is in line with recent in vivo evidence that topically applied alpha-methylspermidine induces anagen in mouse telogen HFs” (p. 5, right column, 1st paragraph).
2) The prior art made of record and considered pertinent to applicant's disclosure Matsumoto et al., (JP2013234149). Matsumoto et al. is pertinent for teaching “a hair quality improver suppressing cuticle lift up in the hair, good in the tough and trim feeling of the hair after use, smooth in finger compatibility, and giving the hair well-textured gloss including moderate moist feeling, dry feeling and damp feeling, and to provide a hair cosmetic using the same”, wherein the hair quality improver is a polyamine composition comprising “at least one kind of spermidine” (Abstract). Result of treating the hair with the polyamine solution was as follows: “the healthy hair sample had a good cuticle state and the cuticle was not lifted up . . . the hair treated by dipping in an aqueous polyamine solution did not show any lift of the cuticle. (Cuticle damage has been improved)” (p. 6, last paragraph).
Nonstatutory Obvious-type Double Patenting
The nonstatutory 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 nonstatutory obviousness-type 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); and 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 a nonstatutory double patenting ground provided the conflicting application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement.
Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b).
Claims 1-14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of U.S. Patent No. 9,241,888. Although the claims at issue are not identical, they are not patentably distinct from each other because they both claim a method of administering a compound of formula 1, e.g., a spermidine compound to the hair.
Response to Arguments
i) Applicant argues that the instant claims are drawn to a method, and the prior art does not teach the step of applying the claimed composition directly on the shaft, cuticle or scales of the keratin structure. Applicant postulates that the prior art, i.e., Giuliani, uses its R-N1-spermidine “to improve the pigmentation action of hair . . . particularly pigmentation of the shaft”, but the teaching is limited to application of “the scalp without being transformed into a different inactive substance as a result of oxidation (p. 2-3).
However, the artisan is reasonably expected to apply the formulations of the prior art to the hair follicles, as well, especially in view of the fact that formulations include “HAIR GEL” (p. 6, Example 1), “HAIR CONDITIONER” (Id. Example 2), and “SHAMPOO” (p. 9, Example 5). Use of these formulations would have inevitably resulted in application to the hair, which includes the cuticle and shaft.
The prior art also teaches direct application to hair follicles in a hair pigmentation study using N-methyl-spermidine (p. 11, lines 10-16), where results showed “the increase in melanin produced in case of treatment with N-methyl-spermidine at both concentrations tested in a dose dependent manner” (p. 12, lines 20-24).
Accordingly, the prior art anticipates, and makes obvious, the topical application of N-methyl-spermidine to hair, including the shaft and cuticle.
ii) Applicant attacks Kasukabe individually stating, “Kasukabe is not directed to a cosmetic treatment method itself, but rather to a process for producing plant-derived polyamine compositions that can subsequently be used as ingredients in cosmetic, pharmaceutical, food, and health-related products” (p. 5); “Kasukabe provides no teaching or suggestion of methylspermidine” (Id.); “Nothing is stated in Kasukabe about an application step or a method for the application of the compound directly on the shaft, cuticle, or on the scales of the keratin structure for restructuring and noticeable improvement in the hair outward appearance” (Id).
However, 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).
In this case, Kasukabe was used to show that, at the time of applicant’s filing, it was known to use spermidine in cosmetics on the eyelashes making obvious use of the compositions of Giulani et al. on the eyelashes.
iii) Applicant argues that the obvious-type double patenting rejection should be withdrawn insofar as the preamble of the claim, which states, “for restructuring the cuticle of a keratin-based structure,” removes the conflict between the instant claims and the patented claims.
However, the rejection will be maintained insofar as both set of claims require application of the same compound to hair. The body of the claims fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention's limitations.
Moreover, “Products of identical chemical composition can not have mutually exclusive properties." MPEP 2112.01. A chemical composition and its properties are inseparable. (Id.) Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. (Id.)
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.
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Any inquiry concerning this communication or earlier communications from the examiner should be directed to WALTER E WEBB whose telephone number is (571)270-3287 and fax number is (571) 270-4287. The examiner can normally be reached from Mon-Fri 7-3:30.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sahana Kaup can be reached (571) 272-6897. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Walter E. Webb
/WALTER E WEBB/ Primary Examiner, Art Unit 1612
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