DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 31, 2023, is being examined under the first inventor to file provisions of the AIA .
Status of the Application
Receipt is acknowledged of Applicants’ claimed invention filed on 03/31/2023 in the matter of Application N° 18/247,542. Said documents are entered on the record. The Examiner further acknowledges the following:
Thus, claims 11-29 represent all claims currently under consideration.
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.
Claim 11 is rejected under 35 U.S.C. 102 as being anticipated by Ahmad US20140271890A1.
Regarding claims 11, Ahmad teaches (See paragraph 0026), a composition containing dimethylglycine, and a salt of dimethylglycine (See paragraph 0031), and caffeine (See paragraph 0040). Therefore, claim 11 is anticipated by Ahmad.
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.
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 at the time any inventions covered therein were effectively filed 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 at the time a later invention was effectively filed 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 11-18 are rejected under 35 U.S.C. 103 as being unpatentable over Ahmad (US20140271890A1), in view of Winter et al. (US4839159A).
Regarding claims 11, Ahmad teaches (See paragraph 0026), a composition containing dimethylglycine, and a salt of dimethylglycine (See paragraph 0031), and caffeine (See paragraph 0040).
Regarding claims 12-14, Ahmad teaches dimethylglycine with a concentration of 5-15 parts. Therefore, it’s equivalent to 5-15% when converted to percentage it falls within the recited range. (See paragraph 0040 and claim 7).
However, Ahmad fails to teaches the concentration of caffeine and classes with a composition that contains 0.001% to 3.0% caffeine and also fails to teach at least one additional active ingredient chosen from carnitine is included in the mixture.
Winter et al. is introduced for its teaching of a topical composition to the skin (see claim 1, as required by instant claims 17) comprising carnitine (as required by instant claim 15 (see claim 1) and antioxidant (a s required by instant claim16).
With regards to instant claim 18, the composition would intrinsically promote metabolism of the skin when applied.
Although the references does not teach the exact concentrations as recited the determination of a dosage having the optimum therapeutic index is well within the level of the ordinary skill in the art, and the artisan would be motivated to determine the optimum amounts to get the maximum effect of the drug, hence the reference makes obvious the instant invention.
Therefore, it would have been obvious to one of ordinary skill in the art to have expanded Ahmad's teaching to include Winter with a reasonable expectation of success in treating the skin as the compounds are known in the art for treating a skin condition.
The motivation to combine can arise from the expectation that the prior art elements will perform their expected functions to achieve their expected results when combined for their common known purpose. Section MPEP 2144.07
Claims 19-29 are rejected under 35 U.S.C. 103 as being unpatentable over Meyer et al. (CN105392531B), in view of Manish et al. (Manish et al. Role of Caffeine in the Management of Androgenetic Alopecia, July-Sep 2012), and Luo et al. Topical and transdermal delivery of caffeine, International Journal of Pharmaceutics Volume 490, Issues 1–2, 25 July 2015, Pages 155-164.
Regarding claim 19, Meyer et al. teach a method of treating hair comprising -Dimethylglycine Ammonium (See Amphoteric emulsifier, paragraph 1), and xanthine alkaloids such as caffeine (See Hair growth activator or inhibitor, paragraph 1). However, Meyer fails to teach the hair loss is selected from the group consisting of alopecia androgenetica etc. and that the composition that contains 0.001% to 3.0% caffeine, and 0.001% to 10.0% by weight dimethylglycine/or a salt of dimethylglycine. Nonetheless, the determination of a dosage having the optimum therapeutic index is well within the level of the ordinary skill in the art, and the artisan would be motivated to determine the optimum amounts to get the maximum effect of the drug, hence the reference makes obvious the instant invention, a result-effective variable, i.e., a variable that achieves a recognized result and, therefore, the determination of the optimum or workable dosage range would have been well within the practice of routine experimentation by the skilled artisan and, further, absent any evidence demonstrating a patentable difference between the compositions used and the criticality of the amount(s).
Regarding claim 22, Manish et al. teach in androgenetic alopecia (AGA), the hair on the scalp gradually thins in a pattern that is both hereditary and androgen-dependent. It is a common dermatological issue that has a major detrimental effect on the social and psychological wellbeing of both men and women (See paragraph 1).
It would have been obvious to one of ordinary skill in the art, prior to the instant effective filing date, to incorporate the teachings of Meyer et al., which disclose N-dimethylglycine ammonium and xanthine alkaloids such as caffeine, into the teachings of Manish et al., which disclose treatments for androgenetic alopecia. A skilled person would have been motivated to do so because caffeine is known to stimulate cellular activity and scalp metabolism, and its inclusion would have predictably enhanced follicle stimulation and hair growth in the androgen dependent thinning hair described by Manish et al.
However, Manish et al. do not teach comprising topically administering the composition to the hair or scalp of the subject.
Luo et al. teaches caffeine is administered topically and transdermally in various cosmetic and pharmaceutical applications as required by instant claims 23, 24, 25, 26, 27, 28, and 29. With regards to the characteristics administering topically to the hair or scalp of the subject, would intrinsically improve the skin condition, improve the epidermal barrier and epidermal barrier integrity of the skin, and increasing the moisture content of the skin, and Improving healing of a wound in the skin.
It would have been obvious to one of ordinary skill in the art, prior to the effective filing date, to combine the teachings of Luo et al., which disclose that in many pharmacological and cosmetic applications, caffeine is applied topically and trans dermally with the teachings of Manish et al. which disclose treatments for androgenetic alopecia. One of ordinary skill in the art would have been motivated to do so because Luo et al. composition provides known methods and actives for improving hair, and their application to the hair-loss context of Manish et al. would have predictably enhanced hair and scalp health.
Response to Arguments
Applicant's arguments filed December 31, 2025 have been fully considered but they are not persuasive.
The applicant contends that the claimed invention is distinct from the compositions disclosed in Meyer et al. and further asserts that a combination of Meyer et al. with Manish et al. and/or Luo et al. would not result in the claimed invention. The applicant additionally argues that the presently claimed compositions, comprising caffeine and N, N-dimethylglycine for topical administration, exhibit advantageous biological effects (e.g., on keratinocyte viability, migration, proliferation, and reduction of hair loss) that are not taught or suggested by the cited references. These arguments are not persuasive.
As previously set forth, Ahmad teaches compositions comprising dimethylglycine and salts thereof in combination with caffeine. Meyer et al. further discloses methods of treating hair using compositions including dimethylglycine (e.g., dimethylglycine ammonium) in combination with xanthine alkaloids such as caffeine. Thus, the combination of dimethylglycine and caffeine, as presently claimed, is taught by the prior art.
Additionally, Manish et al. provides motivation to treat conditions such as androgenetic alopecia, emphasizing the desirability of addressing hair thinning and loss. Luo et al. teaches topical and transdermal administration of caffeine in cosmetic and pharmaceutical compositions, including applications to the hair, scalp, and skin, and further suggests associated skin-related benefits such as improved barrier function, moisture retention, and wound healing.
Taken together, the cited references teach or suggests the use of compositions comprising caffeine and dimethylglycine, applied topically to the hair, scalp, or skin, for treating dermatological conditions, including hair-related conditions. One of ordinary skill in the art would have been motivated to combine these teachings to achieve predictable results, namely, the treatment of hair and scalp conditions using known active agents delivered via known topical formulations.
With respect to the applicant’s assertion of advantageous or unexpected results, the evidence of record is insufficient to demonstrate that such results are unexpected relative to the closest prior art, particularly in view of the overlapping compositions and uses disclosed in the cited references. Improvements in biological parameters such as keratinocyte activity or hair loss reduction would have been reasonably expected from the use of known active ingredients (e.g., caffeine and dimethylglycine) in topical formulations targeting hair and skin conditions.
Conclusion
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 Kimberly Barber whose telephone number is (703) 756-5302. The examiner can normally be reached on Monday through Friday from 6:30 AM to 3:30 PM EST.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert A. Wax, can be reached at telephone number (571) 272-0623. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from Patent Center. Status information for published applications may be obtained from Patent Center. Status information for unpublished applications is available through Patent Center for authorized users only. Should you have questions about access to Patent Center, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free).
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) Form at https://www.uspto.gov/patents/uspto-automated- interview-request-air-form.
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.
/KIMBERLY BARBER/Examiner, Art Unit 1615
/Robert A Wax/Supervisory Patent Examiner, Art Unit 1615
Prosecution Insights