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 election of the compositions of Claims 1-16 in the reply filed on 23 July 2026 is acknowledged. 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)).
Status of the Claims
Claims 1-20 are pending.
Claims 17-20 are withdrawn from consideration as directed to non-elected inventions.
Claims 1-16 are presented for examination and rejected as set forth in greater detail below.
Priority
The instant application claims the benefit of Provisional U.S. application 63/536,922 filed 6 September 2023.
Claim Interpretation
Applicants claims are directed to compositions which combine minoxidil with an a-hydroxy acid, water, and a cosolvent which comprises alcohol, where the alcohol and water are present in a weight ratio of 1 part alcohol to between 1.4-10 parts water.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
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 1-12 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over So (U.S. 6,946,120).
So describes compositions combining an acid such as acetic acid which applicants list as a suitable a-hydroxy acid, a solvent system combining water, a lower alcohol, and polyhydric alcohols, and minoxidil concentrations of approximately 5-15% by weight, buffered to a pH of approximately 5-7, and which exclude propylene glycol altogether. (Col.1, L.56 – Col.2, L.26.) Applicants are reminded that a prima facie case of obviousness typically exists when the ranges of a claimed composition overlap the ranges disclosed in the prior art. In re Peterson, 315 F.3d 1325, 1329 (Fed. Cir. 2003). Where, as here, the art describes concentrations of minoxidil of “approximately 5%,” and a pH of “approximately 5,” this includes values below the ranges recited and therefore within the ranges claimed. Ethanol is the preferred lower alcohol, present in a ratio of water to ethanol of between 9:1 to 1:9, again defining a range overlapping and rendering obvious that of the instant claims. (Col.2, L.32-34). Glycerol is described as a suitable polyhydric alcohol for use in such compositions. (Col.2, L.40-45). So indicates the composition may be provided in a variety of physical forms, including each of foams, mousses, and gels, with hydroxypropyl cellulose described as a suitable gelling agent for use in such compositions. (Col3, L.3-17). So indicates that in addition to components specifically identified, the skilled artisan may incorporate general purpose components ordinarily used in hair treatment compositions. (Col.3, L.40-61). A particular embodiment of a propylene glycol free composition includes 0.6% acetic acid. (Col.4, “EXAMPLE 1”). So describes exemplary embodiments where 10% of each of ethanol and glycerol in water were used to formulate minoxidil compositions. (Col.7, L.60-64). So indicates that minoxidil was found to be extremely soluble in acidic media, with each of the types and proportions of cosolvents present, the pH of the formulation, and the amount of minoxidil bearing on the solubilization of minoxidil in these compositions. (Col.8, L.30-61). The art therefore not only establishes various concentrations of components recited by the claims, at the time the instant application was filed, overlapped the values and ratios recited by the claims, but also establishes that the types and proportions of cosolvents present, the pH of the formulation, and the amount of minoxidil were understood to represent result-effective variables suitable for optimization through nothing more than the routine experimentation of the skilled artisan. As such, if not explicitly recited by the teachings of So, the concentrations and weight ratios recited by each of Claims 1-4, 6, 7, 10, 11, and 16 are nevertheless considered obvious in light of So’s teachings. See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (indicating that where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.).
The specific combination of features claimed is disclosed within the broad teachings of the reference, but such “picking and choosing” within several variables does not necessarily give rise to anticipation. Corning Glass Works v. Sumitomo Elec., 868 F.2d 1251, 1262 (Fed. Circ. 1989). Where, as here, the reference does not provide any motivation to select this specific combination of minoxidil, water, ethanol, glycerol, acetic acid, and hydroxypropyl cellulose in a propylene glycol free composition buffered to a pH of about 5, anticipation cannot be found.
That being said, however, it must be remembered that “[w]hen a patent simply arranges old elements with each performing the same function it had been known to perform and yields no more than one would expect from such an arrangement, the combination is obvious.” KSR v. Teleflex, 127 S.Ct. 1727, 1740 (2007) (quoting Sakraida v. A.G. Pro, 425 U.S. 273, 282 (1976)). “[W]hen the question is whether a patent claiming the combination of elements of prior art is obvious,” the relevant question is “whether the improvement is more than the predictable use of prior art elements according to their established functions.” (Id.). Addressing the issue of obviousness, the Supreme Court noted that the analysis under 35 USC 103 “need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ.” KSR at 1741. The Court emphasized that “[a] person of ordinary skill is… a person of ordinary creativity, not an automaton.” Id. at 1742.
Consistent with this reasoning, it would have been prima facie obvious to have selected various combinations of minoxidil, water, ethanol, glycerol, acetic acid, and hydroxypropyl cellulose in a propylene glycol free composition buffered to a pH of about 5 from within a prior art disclosure, to arrive at compositions “yielding no more than one would expect from such an arrangement.”
Claims 1-16 are rejected under 35 U.S.C. 103 as being unpatentable over So as applied to Claims 1-12 and 16 above, and further in view of Nuriogullari (WO2017/061971).
So, discussed in greater detail above, suggests gel, foam, or mousse compositions combining minoxidil, water, ethanol, glycerol, acetic acid, and hydroxypropyl cellulose in a propylene glycol free composition buffered to a pH of about 5.
So does not, however, recite the inclusion of foaming agents required by Claims 13-15 as suitable components of the foam or mousse compositions suggested, despite indicating that general purpose components ordinarily used in hair treatment compositions also find use in their compositions.
Which would lead the skilled artisan to the teachings of Nuriogullari, which also concerns topically applicable minoxidil foam compositions. (Pg.1, L.4). Like So, Nuriogullari also describes such foams as suitably using combinations of water, ethanol, and glycerol of So as well as the present claims as co-solvents. (Pg.3, L.10-14). Nuriogullari describes minoxidil concentrations in such foams falling within the range of 1-5%, surfactants in concentration of 10-20%, solvents 3-97%, and acids in concentrations of 1-5%. (Pg.3, L.16-18). Cocamide DEA identified by applicants Claim 15 is taught by Nuriogullari as a suitable surface active agent for use in these foam compositions, Pg.6, which Nuriogullari indicates is used to establish and maintain the foam of the composition. (Pg.8).
It would have been prima facie obvious to have incorporated cocamide DEA in concentrations of 1%, overlapping and therefore rendering obvious the foaming agent limitations of the instant claims, as a surfactant in the compositions of So. One having ordinary skill in the art would have been motivated to do so because So indicates that minoxidil foams represent a suitable form of the compositions described, while additionally indicating that not only surfactants but also additional components commonly employed in minoxidil compositions may be incorporated into their compositions. Incorporating Nuriogullari’s cocamide DEA as a foaming surfactant would appear to be little more than the predictable use of prior art elements according to their established functions and prima facie obvious thereby. KSR at 1740.
Conclusion
No Claims are allowable.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SEAN M BASQUILL whose telephone number is (571)270-5862. The examiner can normally be reached Monday through Thursday, 5:30 AM to 4 PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Ali Soroush can be reached at (571) 272-9925. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/SEAN M BASQUILL/Primary Examiner, Art Unit 1614
Prosecution Insights