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 .
Election/Restrictions
Applicant’s response to the restriction/ election requirement from 5/4/2026 is acknowledged. Applicant was required to elect:
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Applicant has made the following election:
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Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
On further consideration of the art, the election of species has been expanded to encompass the broader genus of pyrazine compounds of Applicant’s claim 18, and the broader genus of an auxiliary agent of Applicant’s claims 22. The restriction/ election requirement is hereby MADE FINAL. Claims 16-18, 22-27 and 31-32 are pending, and have been examined herewith.
Claim Rejections - 35 USC § 102
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.
Claims 16-18 and 22-27 are rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by KR 20110006891 A to Hoon et al. (“Hoon”).
Claim interpretation
The present application relates to treatments of hair conditions whether being hair loss or excessive hair growth. The finding is that the TRPM5 receptor is expressed in hair follicles and implicated in hair growth. Accordingly, agonists can be used to promote hair growth and antagonists or down-regulators for hair growth inhibition.
Specific antagonists are dimethylpyrazine, dimethylethylpyrazine, tetramethylpyrazine, 2-heptanone, eugenol, SID2848719 (CAS number 702636-90-6), rutamarin, bergapten, xanthotoxin, isopimpinellin, carbachol, 3-deoxyglu-cosone, glucagon-like peptide 1, (E)- N-(3,4dimethoxybenzylidene)-2-naphthalene-1. -yl) acetohydrazide or a combination thereof, or an aptamer binding to TRPM5 and activating or enhancing said ion channel to produce a cellular response.
Specific inhibitors are any one of the TRPM5 inactivating antagonists/inverse agonists triphenylphosphine oxide, econazole, miconazole, chlorpromazine or a combination thereof, or an aptamer binding to TRPM5 and inactivating, blocking or dampening said ion channel to produce a cellular response or an miRNA, siRNA or a ribozyme targeted to TRPM5.
While it appears, that hitherto implication of TRPM5 receptor in hair follicle metabolism was not known, individual compounds of the claims have however already been described in treatment of hair loss or excessive hair growth.
To that end, where the prior art discloses the same compounds, they will have the same effect regulating hair growth, activating or enhancing the cellular response to TRPM5, or conversely inactivating, blocking or dampening the cellular response of TRPM5.
Hoon discloses formulations for hair growth promotion by induction of VEGF expression, and improvement of hair damage. One active agent is the TRPM5 agonist tetramethylpyrazine and the other the triterpenine madecassoside. Both can also be used in mixture. Formulations can comprise additives such as polysorbate or glycerin and be in the form of, inter alia, cream, lotion or solution. (paragraphs [0001], [0008], [0009], [0015] - [0019], [0026]; claims; examples, Fig. 4).
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.
Claims 31 and 32 are rejected under 35 U.S.C. 103 as being unpatentable over KR 20110006891 A to Hoon et al. (“Hoon”), as applied to claims 16-18 and 22-27 in the 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) rejection above, further in view of Phillips et al., Hair Loss: Common Causes and Treatment, American Family Physician, Sep 15, 2017, available at https://www.aafp.org/afp/2017/0915/p371 (“Phillips”).
Hoon is discussed in the 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) rejection above.
Hoon discloses administration for treatment of hair loss broadly, but does not specifically disclose that the hair loss is specifically nonscarring alopecia, such as androgenetic alopecia.
Phillips discloses that hair loss presents in the form of scarring and nonscarring alopecia, e.g. androgenetic alopecia, and that nonscarring alopecias can be readily diagnosed and treated. (Abstract).
Accordingly, it would have been obvious to a person of skill in the art to modify the teachings of Hoon with these of Phillips in order to practice Applicant’s claimed invention with a reasonable expectation of success. The skilled artisan would have been motivated to do so, since Hoon is broadly directed to treatment of hair loss, and Phillips discloses that the various forms of hair loss are known, to include nonscarring alopecias (of which androgenetic alopecia is one kind) can be readily diagnosed and treated.
Other relevant art
The Examiner also notes for the record the following relevant prior art.
-D2 US 2012/101038 A1
D2 (paragraphs [0002] - [0006], [0012] - [0024], [0081] - [0093]; claims; examples) discloses formulations for hair growth promotion by administration of active agent GLP-1 or active fragment or derivative thereof. Combination therapy is also possible with other hair growth actives (minoxidil, pinacidil, potassium channel openers, 5a-reductase inhibitors). Both cosmetic and therapeutic applications are disclosed (baldness, disease, alopecia)Formulations can comprises additives such as polyethylene glycol, petrolatum and be in the form of cream, spray, lotions or solution inter alia or be in the form of liposomes, microcapsules, nanoparticles (with e.g. HEMC, gelatin, PMMA).
-D3 JP S63 284125 A
D3 discloses formulations for hair growth promotion by administration of active agent eugenol in order to inhibit testosterone 5a-reductase activity. Both cosmetic and therapeutic applications are disclosed (baldness, seborrheic alopecia, hair growth). Formulations used are solutions in ethanol.
-D6 WO 2007/099503 A2
D6 (page 2, line 26 - page 4, line 25; page 5, last paragraph; page 6, last paragraph; page 7, line 6 - line 28; line 3 - page 15, line 16; claims; examples)) discloses agonists of the TRPM8 or TRPA1 receptors for use in the reduction of unwanted human hair growth. As agonists of these both receptors inter alia can be used eugenol. The formulations may comprise PEG, petrolatum and other carriers and can be in the form of creams inter alia (see example 1). Additional hair reducing agents can be used in combination and cosmetic as well as disease conditions of increased hair growth can be treated (hirsutism). The functional reference in the claims to TRPM5 action can accordingly therefore merely be seen a mechanistic explanatory feature. Therefore, claims 1-4 and 6-14 lack novelty and also inventive step in view of cumulated D1-D6 (Article 33(1) and (2) PCT). For molecules that are TRPM5 regulators and not described in the art as actives on hair growth, novelty and inventive step could however possibly be recognised e.g. DMP, 2- Hep and TPPO and in particular regulatory RNA's targeted to TRPM5 gene or gene product (claims 5 and 15).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SVETLANA M IVANOVA whose telephone number is (571)270-3277. The examiner can normally be reached 8:30-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kortney L. Klinkel can be reached at (571) 270-5239. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SVETLANA M IVANOVA/ Primary Examiner, Art Unit 1627
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