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 .
Claims 1-20 have been presented for examination on the merits.
Claim Objections
Claim 9 is objected to under 37 CFR 1.75 as being a substantial duplicate of claim 8. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m). Tretinoin and retinoic acid are considered the same compound.
In claim 13, line 1, the term “an” is missing between -comprising- and -acid-.
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 2, 5, 7 and 15 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.
Claim 2 is indefinite for reciting that the composition is stable for at least 6 months. This is indefinite because the claim does not contain an upper limit and encompasses 12 months, 2 years, 10 years, which are neither supported by the Specification nor possible.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 5 recites the broad recitation characteristics of a patient, and the claim also recites including age, gender, and extent and duration of hair loss, which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claims 7 and 15 are indefinite because they contain a Markush listing of agents wherein tretinoin and retinoic acid are both recited. Tretinoin and retinoic acid are the same compound/agent. As such it is not clear what the difference is between these two recitations.
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.
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.
Claims 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over Wu (US 20200397682).
Wu teaches clear compositions for and methods of retarding hair loss or facilitating hair growth comprising a hair growth active, a C8-C24 alcohol ester of a carboxylic acid and a pharmaceutically acceptable topical carrier comprising monohydric and, optionally, dihydric alcohols and water (See abstract).
Regarding claims 1 and 11, Wu teaches a composition comprising a liquid vesicle comprising one or more of a hair growth or hair regrowth compound that comprises minoxidil, from about 10 to about 60% of a monohydric alcohol, a dihydric alcohol and water (See claim 1). The compositions may comprise a solubilizer comprising ethanol, glycerin, propylene glycol or mixtures thereof (See [0208]) and one or more emollient including polysorbate 80 (See [0215]-[0216]). The compositions have an apparent pH of from about 4.0 to about 7.0, optionally from 4.0 to 6.0 (See [0221]).
Regarding claim 2, Wu teaches that the term “storage stable” or “storage stability” means a composition (such as a solution) which is uniform and homogeneous and which is not separated into two or more distinct phases upon visual inspection after the composition is stored in closed, airtight glass containers for at least 1 week, optionally at least 7 weeks, at a constant temperature of 40° C (See [0194]-[0195] and [0317]).
Regarding claims 3-4, Wu teaches a clear solution composition comprising from about 0.1% to about 20% by weight of the hair growth or hair regrowth compound (such as minoxidil or pharmaceutically acceptable addition salts thereof); or from 0.5% to about 10% and optionally from 0.5 to 5% by weight of the composition (see [0007], [0042] and claims 4-5).
Regarding claim 5, Wu teaches that the amount of the compound of Formulas I and/or II is a safe and effective amount for promoting hair growth. (See [0042]).
Regarding claim 6, Wu teaches that the formulation is stored in a closed, airtight glass containers (See [0194]). Regarding the dosing instructions, MPEP states that “Where the printed matter is not functionally related to the substrate, the printed matter will not distinguish the invention from the prior art in terms of patentability.” In re Ngai, 367 F.3d 1336, 70 USPQ2d 1862 (Fed. Cir. 2004). King Pharmaceuticals, Inc. v. Eon Labs, Inc., 616 F.3d 1267; 95 USPQ2d 1833 (Fed. Cir. Aug. 2, 2010). See MPEP § 21102.01 [R-3].
Regarding claims 7-10 and 15, Wu teaches that the said compositions may comprise one or more additional agents to promote hair growth including tretinoin, retinoic acid, finasteride, dutasteride, etc, and combination thereof (See [0082]-[0083], [0089] and [0101]).
Regarding claim 12, Wu teaches a composition comprising a solubilizer such as ethanol, glycerin and propylene glycol, at an amount of from 0.1 to 50% including 12% (see [0208] and [0294]), from about 10% to about 40% of a dihydric alcohol (such as propylene glycol); and from about 10 to about 60% by weight of a C2-C4 alcohol (such as ethanol) (See [0007], [0209], [0294] and claim 1), water in an amount of from about 20% to about 40%, by weight of the total composition (See [0069]), and polysorbate 80 at about 0.1 to 15% by weight (See [0217]).
Wu provides multiple examples of the disclosed composition. A composition in Table 22, is reproduced below.
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Regarding claims 13-14 and 16, Wu teaches that the hair growth compounds are dissolved in or contain as auxiliary components one or more solubilizing acid(s) which dissolve minoxidil such as citric acid, lactic acid, etc. The said solubilizing acid(s) is present in the composition in an amount from about 0.1% to about 10% by weight of the composition. In the example above citric acid is present at 0.12% (See [0212] and [0214]).
Regarding claim 17, Wu teaches methods of preparing the said solution composition. The inventive formulation disclosed in Table 22 is prepared according to the following procedure:(1) The ethyl alcohol is added to a suitably sized first glass container with an overhead mixer.(2) The pentylene glycol, glycerin, citric acid, & lactic acid are added to the container and the mixture is mixed for about 2 minutes.(3) The minoxidil, and BHT are added to the beaker and is stirred for about 10 minutes or until dissolved.(4) The water is added slowly and the mixture is mixed for about 2 minutes.(5) In a separate second beaker equipped with a hotplate and magnetic stirrer, the steareth-10, and cetyl lactate acetate are premixed.(6) The premix heated to about 60° C. and is stirred with the magnetic stirring bar until completely melted and a uniform oil phase is formed.(7) The premix is added with stirring to the minoxidil containing water phase in the first container and is mixed for about 5 minutes.(9) The Polyquaternium 37 is added to the first container and the mixture in the first container is homogenized at 7,000 rpm using a Silverson L4RT homogenizer (Silverson, Birmingham, UK) for about 5 minutes.
While the order of the mixing and certain steps are not as expressly disclosed in instant claim 17, the produced formulation is very similar and the modifications would have been obvious to one of ordinary skill in the art.
That is “Unless Applicant demonstrates the criticality of the order of addition and that the prior art is not the same product as the instant application, changes in sequence of adding ingredients has been rendered to be prima facie obvious” MPEP § 2144.04 [R-1] In re Gibson, 39 F.2d 975, 5 USPQ 230 (CCPA 1930) (Selection of any order of mixing ingredients is prima facie obvious).
Regarding claims 18-20, Wu teaches adding at least one acid including citric acid, at least one other compound for promoting hair growth such as tretinoin or finasteride and discloses the amount of minoxidil. See above.
It would have been prima facie obvious to a person of ordinary skilled in the art at the time the invention was made to have followed the teachings of Wu to arrive at the instant invention.
One of ordinary skill in the art would have been motivated to follow Wu’s method to make a clear solution composition comprising minoxidil, ethanol, water, propylene glycol, polysorbate 80 and citric acid for promoting hair growth or preventing hair loss in a subject with a reasonable expectation of success because Wu teaches this composition. The exemplified formulations of Wu do not appear to contain polysorbate 80, and as such the claims are not considered anticipated by Wu, however as shown above Wu teaches each and every element of the claimed invention and provides motivation for one of ordinary skill in the art to incorporate an additive such as polysorbate 80 for its formulation properties.
In other words, the claims would have been obvious because a person of ordinary skill has good reasons to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely the product not of innovation but of ordinary skill and common sense.
Claims 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over Marotta et al (Clinical efficacy of a topical compounded formulation in male androgenic alopecia: minoxidil 10%, finasteride 0.1%, biotin 0.2% and caffeine citrate 0.05% hydroalcoholic solution) in view of Wu (US 20200397682).
Marotta et al teach a hydroalcoholic solution comprising minoxidil and finasteride as well as additives for promoting hair growth. It is disclosed that
the objective of this study was to investigate the clinical efficacy and patient satisfaction of a topical compounded formulation (minoxidil 10%, finasteride 0.1%, biotin 0.2%, and caffeine citrate 0.05% hydroalcoholic solution) in male androgenetic alopecia patients. A total of five individual, prospective case studies were conducted and patients were provided with the topical formulation and instructed to apply a measured 1-mL dose to the entire frontal, parietal, and occipital scalp, twice daily for 6 months. Patients visited the practice periodically (90 days, 120 days, and 180 days post-treatment) for clinical evaluation, photographic assessment, and measurement of their treatment satisfaction by the Men’s Hair Growth Questionnaire. By the end of the study, at 180 days, the dermatologist-in-charge concluded that the topical treatment was successful for all five patients. Although moderate, the clinical improvements were visually noticeable as most patients had thicker, more voluminous hair; improved scalp coverage; and improved general hair appearance. These results were consistent with the photographic assessment, which demonstrated a global average increase of +1.05 in the patients’ hair density. According to the patients’ self-assessment, the topical compounded formulation was effective following 3 months and 6 months of continuous treatment (See abstract).
Regarding claims 1, 3-8, 11, 13, 17-20, Marotta a et al teach the following formulation and a method of preparing it:
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Regarding claim 2, Marotta a et al disclose that the said formula developed has an adjusted ratio of purified water, ethyl alcohol and propylene glycol and the beyond-use date attributed is 6 months (See page 71, last 2 lines of col. 1 to 1st line of col. 2).
Marotta et al do not expressly disclose adding polysorbate 80, its amount, adding tretinoin or retinoic acid, the lower amount of minoxidil in claim 4, the higher amount of propylene glycol or the amount of acid. These are known in the art as shown Wu
Wu’s teachings are delineated above and incorporated herein.
It would have been prima facie obvious to a person of ordinary skilled in the art at the time the invention was made to have combined the teachings of Wu with that of Marotta et al to arrive at the instant invention.
One of ordinary skill in the art would have been motivated to do so because Marotta et al teach a hydroalcoholic solution comprising minoxidil and finasteride that has been shown to be effective in treating hair loss and promoting hair growth and has at least 6 months stability. Additionally, Wu also teaches an aqueous alcohol clear solution comprising minoxidil and other hair promoting active agents including finasteride, tretinoin and dutaseride as well as polysorbate 80 and a suitable concentration range of an acid to prepare a solution with a pH of from about 4 to about 5 as well as a method to make this clear solution composition comprising minoxidil, ethanol, water, propylene glycol, polysorbate 80 and citric acid for promoting hair growth or preventing hair loss in a subject. Thus, it would have been obvious to one of ordinary skill in the art that the teachings of Wu can be incorporated into the compounded formulation of Marotta et al with a reasonable expectation of success.
In other words, the claims would have been obvious because a person of ordinary skill has good reasons to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely the product not of innovation but of ordinary skill and common sense.
Claims 1-20 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Mina Haghighatian whose telephone number is (571)272-0615. The examiner can normally be reached M-F, 7-5 EST.
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/Mina Haghighatian/
Mina Haghighatian
Primary Examiner
Art Unit 1616