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 .
Status of the Application
This Office Action is in response to Applicant's arguments filed on May 26, 2026. Claim(s) 1-5, 10-17, 20, 21, 25-30, 34-38, and 40 are pending. Claims 11-17, 20, 21, 30, and 34-38 are withdrawn. Claims 1-5, 10, 25-29, and 40 are examined herein.
Response to Arguments
Applicant’s arguments with respect to the 103 rejection of claims 1-5, 10, 25-29, and 40 as being unpatentable over Weisenfluh (US 9,757,324) as evidenced by Cosmetics Info (https://web.archive.org/web/20131008044831/https://www.cosmeticsinfo.org/ingredient/xanthan-gum/; 2013), in view of Lederman (US PG PUB 2011/0130711) of record (IDS 9/9/22) have been fully considered.
Applicant argues:
In addition, the Examiner states that "Weisenfluh does not teach 'a castor oil derivative', however as recited in applicant's specification, emu oil is also an oil envisioned as an equivalent oil to that of castor oil [0029]." Applicant respectfully disagrees. Nowhere does the specification or art indicate that emu oil is an equivalent oil to castor oil nor would one skilled in the art consider emu oil and castor oil to be equivalent. Applicant's disclosure that emu oil may be used as an alternative merely indicates that emu oil may perform some similar formulation role under certain embodiments. Claim 1 as amended specifically recites a composition comprising minoxidil having a concentration of about 0.25% (w/w) to about 1.5% (w/w) of the total composition, a castor oil derivative, wherein the castor oil derivative is about 8% (w/w) to about 15% (w/w) of the total composition, and a pharmaceutically acceptable carrier. Claim 1 does not include alternative embodiments. The claim limitation must be given meaning and effect. MPEP 2111.
The Examiner's recitation of alternatives found in the application under examination as evidence of obviousness is a clear impermissible use of hindsight in examination. "Knowledge of applicant's disclosure must be put aside in reaching this determination [of obviousness]" (MPEP 2142). Weisenfluh provides no teaching, suggestion, or motivation for use of castor oil. As acknowledged by the Examiner, Weisenfluh also does not disclose an injectable composition. See the previously submitted Declaration by Dr. Lars Brichta on November 25, 2024 regarding the benefits of the claimed injectable composition, e.g. paragraphs 11 and 16.
Applicant’s argument arguments are persuasive. Said rejection is hereby withdrawn.
The new rejection is made in the Non-Final Office action below.
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 of this title, 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.
Claims 1-5, 10, 25-29, and 40 are rejected under 35 U.S.C. 103 as being unpatentable over Weisenfluh (US 9,757,324) as evidenced by Cosmetics Info (https://web.archive.org/web/20131008044831/https://www.cosmeticsinfo.org/ingredient/xanthan-gum/; 2013), in view of Lederman (US PG PUB 2011/0130711) of record (IDS 9/9/22) in further view of Schlessinger (US 8,968,755).
Weisenfluh teaches a composition for use in treating hair loss, consisting of emu oil and one or more additional active ingredients selected from the group consisting of Finasteride and Minoxidil, wherein when the active ingredient is Finasteride.
Weisenfluh teaches Finasteride is present at a concentration of between about 50 and about 100 mg/100 ml emu oil.
Weisenfluh teaches when the active agent is Minoxidil, it is present at a concentration of 2-5% by weight of the composition. Note: the specification of the instant invention teaches “about” to mean + 10%, therefore “about 1.8%” can be 1.98% (rounding up to 2%), thereby the limitations regarding minoxidil concentration are met.
Weisenfluh teaches when used to treat hair loss, including alopecia and baldness, the compositions commonly include emu oil and one or more of Finasteride and Minoxidil (column 1, lines 25-41).
Weisenfluh teaches minoxidil sulfate is mixed with emu oil in a concentration ranging from 2% to 5% (column 4, lines 47-49).
Weisenfluh does not teach “a castor oil derivative”, however as recited in applicant’s specification, emu oil is also an oil envisioned as an equivalent oil to that of castor oil [0029].
Weisenfluh teaches the formulation can also include, in addition to these agents, other cosmetic, dermatological, and pharmaceutical active agents, including, but are not limited to: antioxidants; free radical scavengers; depigmentation agents; reflectants; antimicrobial (e. g., antibacterial) agents; allergy inhibitors; anti-aging agents; anti-wrinkling agents, antiseptics; analgesics; anti-inflammatory agents; fresheners; healing agents; anti-infectives; inflammation inhibitors; vasoconstrictors; vasodilators; wound healing promoters; peptides, polypeptides and proteins; skin lightening agents; antifungals; counterirritants; make-up preparations; vitamins; amino acids and their derivatives; herbal extracts; flavoids; sensory markers (i. e., cooling agents, heating agents, etc.); skin conditioners; chelating agents; cell turnover enhancers; nourishing agents; moisture absorbers; sebum absorbers and the like; skin penetration enhancers; and other active ingredients. Other ingredients can include: Water (purified), PEG-4, Aloe barbadensis leaf juice, Allium cepa (onion) bulb extract, xanthan gum, allantoin, methylparaben, sorbic acid, and fragrance (column 7, 8-27).
As evidence by Cosmetics Info, xanthum gum is an emulsifying agent.
Weisenfluh teaches the formulations may employ preservatives (column 8. Lines 5-26).
Weisenfluh teaches representative antioxidants include vitamin E, tocopheryl acetate, betaglucan, coenzyme Q10, butylated hydroxy toluene (BHT), butylated hydroxy anisole (BHA), superoxide dismutase, propylgallate, and the like (column 10, lines 26-30).
Weisenfluh teaches the hair loss compositions are administered topically (prior art claim 4).
Weisenfluh does not teach an injectable composition as required by the limitations of the instant claims.
Lederman teaches a method for stimulating hair growth comprising agents such as minoxidil [0006], castor oil [0080], preservatives [0081], antioxidants including butylhydroxytoluene, among other agents [0093], although not to the particularity as Weisenfluh.
Lederman teaches the composition may be sprayed, dripped, painted, propelled, misted, or injected in order to apply it to the site of the hair follicle ([0123]; [0135]) in addition to topical administration [0122].
Schlessinger teaches topical skin and follicle-treating compositions containing lipid-soluble active extracts. Schlessinger teaches compositions specifically combining emu oil with castor oil derivatives, namely glyceryl ricinoleate, ethyl ricinoleate and glycol ricinoleate, to act as transdermal delivery vehicles for therapeutic active agents targeting dermal and follicular tissue.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have known of the topical administration of compositions comprising minoxidil and/or finasteride and emu oil for the treatment of hair loss as taught by Weisenfluh to have also envisioned the administration of the hair loss compositions using castor oil and administered as an injection. The artisan would have been motivated, based on the teachings of Lederman, to administer the hair loss composition as an injectable composition using castor oil. Lederman teaches compositions useful in hair growth with overlapping active agents and excipients using a variety of routes of administration, including topical and injectable. Moreover, Schlessinger provides the motivation to employ emu oil and castor oil derivatives such as glyceryl ricinoleate, ethyl ricinoleate and glycol ricinoleate, to act as transdermal delivery vehicles for therapeutic active agents targeting dermal and follicular tissue. Optimization of parameters, particularly the mode of administration, is a routine practice that is within the purview of a person of ordinary skill in the art to employ.
Moreover, explorations of ratios/amounts of active compound to other ingredients (i.e., penetration enhancers/emulsifying agents) with the aim of optimizing said ratios with respect to desired properties (improved stability, skin permeability, overall improved drug delivery) is considered within the competency of one of ordinary skill in the art to employ with a reasonable expectation of success. Thus, absent some demonstration of unexpected results from the claimed parameters, this optimization of ranges in which known excipients are being combined would have been obvious at the time of Applicant's invention.
Therefore, based on the foregoing reasons, the instant claims are deemed unpatentable over the cited art.
Conclusion
Claims 1-5, 10, 25-29, and 40 are not allowed.
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Any inquiry concerning this communication or earlier communications from the examiner should be directed to Sahar Javanmard whose telephone number is (571)270-3280. The examiner can normally be reached on Monday-Friday, 9:00-5:00 EST.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, James Alstrum-Acevedo can be reached on 571-272-5548. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
/SAHAR JAVANMARD/Primary Examiner, Art Unit 1627
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