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 July 1, 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 Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims
Claim Rejections - 35 USC § 103 – Obviousness (Maintained Rejection)
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.
1) Claims 1, 4-11 and 14-16 are rejected under 35 U.S.C. 103 as being unpatentable over Korkmaz et al. (US 20190110969) in view of Mahapatra et al. (J. Clin Aesthet. Dermatol. 2016).
Korkmaz et al. disclose hair growth compositions comprising a mixture of actives in a cosmetically acceptable carrier (Abstract). The compositions may be used as treatments for alopecia. The hair treated may include eyebrow hair and eyelash hair (paragraph 0007). The compositions may be formulated for topical administration. In some embodiments, the compositions provided herein may be formulated into ointment, cream, suspension, lotion, powder, solution, paste, gel, spray, aerosol, foam, or oil. In some embodiments, the compositions provided herein may be formulated into a cream, ointment, gel, or foam (paragraph 0205). The compositions comprise a coenzyme, an epigenetic modifier, a blood circulator, a 5-alpha reductase modulator, and a cosmetically acceptable carrier. The term “epigenetic modifier” refers to an agent that has the ability to regulate, modify, and/or reverse an epigenetic modification of a nucleic acid, such as DNA or RNA, or a protein, such as a histone. Examples of an epigenetic modifier include melatonin, which is an epigenetic modifier & epigenetic modulator. The epigenetic modifier comprises 0.5% to 2.5% by volume (paragraph 0047) (instant claim 8). The composition comprises a 5-alpha reductase modulator. Non-limiting illustrative examples of a 5-alpha reductase modulator include finasteride (paragraph 0087). The total amount of 5-alpha reductase modulator in the composition, by volume, may be about 0.05% to about 6% (paragraph 0089). Vitamin A may also be added to the composition and may comprise 0.01 to 0.3% by volume (paragraph 0094).
In one embodiment, the epigenetic modifier comprises melatonin and the composition further comprises urea, allicin, eugenol, zinc oxide, beta-carotene, minoxidil, pyrrolidinyl diaminopyrimidine oxide, arginine, capsaicin, finasteride, emodin, vitamin C, vitamin E, copper peptide, and clove oil (paragraph 0142). In another embodiment, the composition further comprises latanoprost, which comprises 0.01-1% by volume (paragraph 0122).
An example comprises 2.5% minoxidil (instant claims 5-6), 1% melatonin (instant claim 1), 0.5% finasteride (instant claims 1 and 7) and a cosmetically acceptable carrier.
Korkmaz et al. differ from the instant claims insofar as they do not disclose platelet rich fibrin.
Mahapatra et al. disclose using platelet rich fibrin for treating patients with androgenetic alopecia. The crucial discovery of platelet-derived growth factors has resulted in the development of novel autologous therapeutic methods. Platelet-rich fibrin matrix plays a key role in hair regeneration using follicular unit transplantation techniques. The PRFM may stimulate dermal angiogenesis and wound healing, which helps improve survival of the transplanted graft and regeneration. The compositions are injected into the scalp of the subject.
Mahapatra et al. differ from the instant claims insofar as they don’t disclose the therapy is used with a pharmaceutical composition comprising melatonin and finasteride.
It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose. The idea of combining them flows logically from their having been individually taught in the prior art. MPEP 2144.06. It would have been obvious to one of ordinary skill in the art prior to filing the instant application to have applied a composition comprising melatonin and finasteride in conjunction with receiving platelet rich fibrin in a method of reducing hair loss/increasing hair thickness because both are used for the same purpose and the idea of combining them flows logically from their having been individually taught in the prior art. See MPEP 2144.06.
It would have been obvious to one of ordinary skill in the art prior to filing the instant application to have applied a composition comprising melatonin and finasteride in conjunction with receiving platelet rich fibrin in a method of reducing hair loss/increasing hair thickness motivated by the desire to use a combination that can treat hair loss, such as hair loss caused by androgenetic alopecia, by different mechanisms to ensure the best outcome. The addition of the topical formulation of Korkmaz et al. would support the method of using PRF because it has actives that help promote hair growth.
Response to Arguments
The Examiner submits that in regards to Mahapatra not disclosing that PRF promotes hair growth, the reference discloses that PFR helps improve the survival of the hair graft. This would meet the limitation of reducing hair loss. PFR was also used in a method for treating alopecia as is the case in Korkmaz. Therefore, it would have been obvious to have added these two methods together because each method yield the same end result, treating alopecia. Further, the claims recite “at a determined time”. This time frame would encompass a wide range. Therefore, the composition is not required to be applied together with PFR. It is only required that the PFR will be administered sometime in the future or was administered sometime in the past. In regards to the alleged unexpected results, one of ordinary skill in the art would reasonably conclude that using the PFR together with a composition comprising finasteride and melatonin would increase hair growth, especially when treating alopecia, because they would have an additive effect. PFR would stabilize the hair, while the composition would stimulate hair growth. One would reasonably conclude that when PFR is not stabilizing the amount of hair, the cause of the hair loss would still be causing loss of hair. This would make it appear that hair growth was slower when PFR was not used. Even if this was not the case, PRF was used at a specific time with the composition comprising finasteride and melatonin. Therefore, the claims are not commensurate in scope with the alleged unexpected results because the claims do not recite a specific time frame. In regards to no other treatment being used, the claims do not recite that no other treatment can be used, nor does it limit claims to the two recited treatments. Therefore, the rejection is maintained.
2) Claims 12-13 are rejected under 35 U.S.C. 103 as being unpatentable over Korkmaz et al. (US 20190110969) in view of Mahapatra et al. (J. Clin Aesthet Dermatol. 2016) in further view of Ghisalberti (WO 2006087392).
Korkmaz et al. in view of Mahapatra et al. is discussed above and differs from the instant claims insofar as it does not disclose retinoic acid.
Ghisalberti discloses composition and methos for preventing hair loss and favoring its regrowth in subjects affected by androgenetic alopecia (Abstract). The composition may comprise finasteride. Retinoids may be added and have the capacity to increase and regulate the cellular proliferation, to promote the epithelial differentiation and to increase the vascular proliferation in the hair bulb. Retinoic acid is particularly indicated for its ability to increase the number of membrane receptors for EGF without reducing their affinity. Illustrative examples of retinoids include: retinol, retinaldehyde and retinoic acid (tretinoin).
It would have been obvious to one of ordinary skill in the art prior to filing the instant application to have added retinoic acid to the composition of Korkmaz et al. to use in the method for treating hair loss of Korkmaz et al. in view of Mahapatra et al. motivated by the desire to increase and regulate the cellular proliferation, to promote the epithelial differentiation and to increase the vascular proliferation in the hair bulb as well as to increase the number of membrane receptors for EGF without reducing their affinity as disclosed by Ghisalberti.
Response to Arguments
The Examiner submits that Ghisalberti cures the deficiencies of Korkmaz and Mahapatra by disclosing retinoic acid. Therefore, the rejection is maintained.
Conclusion
Claims 1 and 4-16 are rejected.
No claims 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 LEZAH ROBERTS whose telephone number is (571)272-1071. The examiner can normally be reached Monday-Friday 11:00-7:30.
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/LEZAH ROBERTS/ Primary Examiner, Art Unit 1612
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