DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after 16 March 2013, is being examined under the first inventor to file provisions of the AIA .
Status of the Claims
Amendments to the Specification, Amendments to the Claims and Arguments/Remarks filed 10 April 2026, in response to the Office Correspondence dated 12 January 2026, are acknowledged.
The listing of Claims filed 10 April 2026, have been examined. Claims 11-14, and 16-23 are pending. Claims 11, 14, 19-21, and 23 are amended, claims 1-10 and 15 are canceled, and no new claims have been added.
Response to Amendment
The amendments to claims 11, 14, 19-21, and 23, and cancellation of claim 15, have been entered. The amended title, “Method for Treating Hair and Scalp Using Dimethylglycine Compositions”, is accepted as descriptive. Accordingly, the title objection under 37 C.F.R. § 1.72 is withdrawn.
The objection to claim 14 is withdrawn in view of the amendment to “a hair and/or skin care composition.” The applicant’s amendment clarifying that the composition is “a hair and/or skin care composition” adequately resolves the prior ambiguity.
The applicant amended claim 11 to introduce “hair loss”, thereby providing antecedent basis for claim 16. The applicant has also amended claims 19, 20, and 23 to clarify that the recited weight percentages are based on the total weight of the composition. Thus, claims 16, 19, 20 and 23 have been amended to fix the deficiencies noted in the prior rejected under 35 U.S.C. § 112(b). Accordingly, these rejections are withdrawn. However, a new objection to amended claims 21 and 23; a new rejection of amended claim 14 under 35 USC § 112(b); and a new enablement rejection under 35 USC § 112(a) of amended claim 11 (including dependent claims 12-14 and 16-23) for claimed “preventing”, have been made, as set forth below.
Based on the introduction of a new limitation, not previously recited in amended claim 11, from which claims 12-14 and 16-23 depend, the prior rejections of claims 11, 21 and 22 under 35 U.S.C. § 102(a)(1) as being anticipated by Albrecht; the rejection of claims 11-13, 17-20 and 23 under 35 U.S.C. § 103 as being unpatentable over Albrecht; and the rejection of claims 11, and 14-16 under 35 U.S.C. § 103 as being unpatentable over Albrecht in view of Taylor are withdrawn. New rejection of claims 11-14 and 16-23 under 35 USC § 103, necessitated by the amended to claim 11, are set forth below.
The provisional nonstatutory double patenting rejections over co-pending U.S. Application No. 18/247,527 and 18/247,542 are also maintained. For the reasons set forth below in the Response to Arguments,
Maintained Rejections
The following rejections are maintained from the previous Office Correspondence dated 12 January 2026, since the art which was previously cited continues to read on the amended/newly cited limitations.
Claim Rejections – Nonstatutory Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
Claims 11-23 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 12-14, 16-20, 22-24 and 30 of co-pending U.S. Application No. 18/247,527. Although the claims at issue are not identical, they are not patentably distinct from each for the reasons outlined below. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 12-14, 16-20, 22-24 and 30 of co-pending U.S. Application No. 18/247,527 substantially overlap with claims 11-23 of the instant application. Co-pending U.S. Application No. 18/247,527 explicitly claims a composition comprising dimethylglycine or a salt thereof for the treatment of hair and skin (Abstract).
Claims 12-14, 16-20, 22-24 and 30 and the specification of co-pending U.S. Application No. 18/247,527 application disclose in detail and in preferred embodiments, the limitations of the composition recited in the instant invention claims 11-23, aside from the wherein the composition comprises at least one other active ingredient selected from caffeine, menthol, biotin, zinc PCA, niacinamide, panthenol, ectoin, ubiquinone-10; taurine, pantolactone, echinacea, camitine, tocopheryl acetate, and combinations thereof (instant claim 21). Alternatively, co-pending U.S. Application No. 18/247,527 limits the composition to comprising at least one other active ingredient selected from caffeine, menthol, biotin, zinc PCA, niacinamide, panthenol, ectoin, ubiquinone-10; taurine, pantolactone, echinacea, tocopheryl acetate, and combinations thereof. The inclusion of camitine in the alternative is not included. This is an obvious variation.
It would have been obvious to one of ordinary skill in the art to use the topical compositions disclosed and claimed in co-pending U.S. Application No. 18/247,527 for its expressly disclosed purpose, treating the hair and scalp, via a method for treating hair and scalp of a subject comprising administering the composition. The claimed method in the instant application is the obvious intended use of the composition claimed in the co-pending application (see In re Basell Poliolefine Italia S.P.A., 547 F.3d 1371, 1379 (Fed. Cir. 2008), wherein holding that a product claim and a claim to a method of using that product for its intended purpose are often not patentably distinct).
In view of the foregoing, the claimed subject matter of the instant application is not patentably distinct from the invention claimed in the commonly owned, co-pending application. The method of the instant claims is an obvious variation and the obvious intended use of the composition claimed in the co-pending application. This provisional rejection is made to prevent an unjustified timewise extension of the patent right for an invention that is not patentably distinct from the invention claimed in the co-pending application.
To overcome this rejection, the Applicant may cancel or amend the claims to render them patentably distinct over the claims of co-pending U.S. Application No. 18/247,527, or file a terminal disclaimer in compliance with 37 CFR 1.321(c) if the claims are otherwise allowable and you agree to tether the term of any patent granted from this application to the term of the patent granted from the reference application.
Claims 11-23 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 11, 13, 15-23 and 29 of co-pending U.S. Application No. 18/247,542. Although the claims at issue are not identical, they are not patentably distinct from each other for the reasons outlined below. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 11, 13, 15-23 and 29 of co-pending U.S. Application No. 18/247,542 substantially overlap with claims 11-23 of the instant application.
Co-pending U.S. Application No. 18/247,542 explicitly claims a composition comprising dimethylglycine or a salt thereof for the treatment of hair and skin (Abstract).
Claims 11, 13, 15-23 and 29 and the specification of co-pending U.S. Application No. 18/247,542 application disclose in detail and in preferred embodiments, the limitations of the composition recited in the instant invention claims 11-23, aside from the wherein the composition comprises at least one other active ingredient selected from caffeine, menthol, biotin, zinc PCA, niacinamide, panthenol, ectoin, ubiquinone-10, taurine, pantolactone, echinacea, camitine, tocopheryl acetate, and combinations thereof (instant claim 21) whereas the co-pending U.S. Application No. 18/247,542 limits the composition to comprising caffeine specifically (claim 11 and 19) and at least one other active ingredient selected from menthol, biotin, zinc PCA, niacinamide, panthenol, ectoine, ubiquinone-10, taurine, pantolactone, echinacea, camitine, tocopheryl acetate and combinations thereof. This is an obvious variation.
While the pH limitation for the composition of instant claims 18 and 23 is not expressly required by the co-pending application claims, the specification of the co-pending application recites, “The pH of the composition is preferably 3.0 to 5.9…In this range, the compositions used according to the invention are not only particularly stable chemically, physically and microbiologically, but are also extremely compatible medically and cosmetically on the scalp and hair.” (¶[0069]), mirroring the instant claim 18 and 23 pH requirement.
While the 2-40% weight surfactant limitation for the composition of instant claims 20 and 23 is not expressly required by the co-pending application claims, the specification of the co-pending application recites, “The composition according to the invention contains surfactants preferably in an amount of 2% to 40% by weight…” (¶[0045]), mirroring the instant claim 20 and 23 surfactant concentration requirement.
It would have been obvious to one of ordinary skill in the art to use the topical compositions disclosed and claimed in co-pending U.S. Application No. 18/247,542 for its expressly disclosed purpose, treating the hair and scalp, via a method for treating hair and scalp of a subject comprising administering the composition. The claimed method in the instant application is the obvious intended use of the composition claimed in the co-pending application (see In re Basell Poliolefine Italia S.P.A., 547 F.3d 1371, 1379 (Fed. Cir. 2008), wherein holding that a product claim and a claim to a method of using that product for its intended purpose are often not patentably distinct).
In view of the foregoing, the claimed subject matter of the instant application is not patentably distinct from the invention claimed in the commonly owned, co-pending application. The method of the instant claims is an obvious variation and the obvious intended use of the composition claimed in the co-pending application. This provisional rejection is made to prevent an unjustified timewise extension of the patent right for an invention that is not patentably distinct from the invention claimed in the co-pending application.
To overcome this rejection, the applicant may cancel or amend the claims to render them patentably distinct over the claims of co-pending U.S. Application No. 18/247,542, or file a terminal disclaimer in compliance with 37 CFR 1.321(c) if the claims are otherwise allowable and you agree to tether the term of any patent granted from this application to the term of the patent granted from the reference application.
New Rejections
The following new rejections are made from the previous Office Correspondence dated 12 January 2026, as the applicant's amendment necessitated the new grounds of rejection presented below based on the amended/newly cited limitations.
Claim Objections
Claims 21 and 23 are objected to because of the following informalities:
Amended claims 21 and 23 are objected to for punctuation. A semicolon appears after “ubiquinone-10”, which should be a comma for consistency.
Claim Rejections - 35 USC § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. § 112(a):
IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. § 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 11-14, and 16-23 is rejected under 35 U.S.C. § 112(a) or 35 U.S.C. § 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement for being directed to preventing hair loss.
Claim 11 broadly claims a method for "treating and/or preventing hair loss" from any cause, using any composition that merely contains dimethylglycine (DMG) and/or a salt thereof. The claim encompasses any route of administration (topical, oral, parenteral, etc.), any dosage form, any concentration of dimethylglycine (DMG) or its salts, any subject, any cause of hair loss (androgenetic, alopecia areata, chemotherapy-induced, senescent, diffuse, etc.), and any formulation (with or without carriers, surfactants, pH buffers, additional actives).
The claim contains subject matter which was not described by the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the full scope of the claimed invention. The specification need not describe every conceivable embodiment, but the enablement must be commensurate in scope with the claims.
To be enabling, the specification of the patent application must teach those skilled in the art how to make and use the full scope of the claimed invention without undue experimentation. The factors that may be considered in determining whether a disclosure would require undue experimentation are set forth by In re Wands (858 F.2d 731, 8 USPQ2d 1400 (Fed. Cir. 1988); “Wands factors”). To determine enablement based on disclosure in the specification, the eight Wands factors have been applied to the instant situation as follows:
Breadth of the claims – Claim 11 is exceedingly broad. It covers all causes of hair loss listed in dependent claim 16 and beyond, all routes of administration (i.e., topical, oral, parenteral, subcutaneous, intradermal, etc.), all concentrations of DMG including trace amounts, all formulations (with or without surfactants, pH adjusters, preservatives, additional active ingredients), all dosing regimens (once daily, twice daily, weekly, etc.), and all subjects (men, women, children, elderly, various health statuses). The specification enables only a small fraction of what claim 11 covers topical administration of DMG in combination with caffeine in a few specific shampoo and tonic formulations, tested for what appears to be androgenetic or age‑related hair loss (based on the subject populations described). The person of ordinary skill in the art would not know, without undue experimentation, whether oral DMG works, whether DMG alone works, whether DMG works for alopecia areata, or what concentration is minimally effective.
Nature of the invention – The invention is in the field of cosmetic and medicinal treatment of hair loss. This field is notoriously unpredictable. Hair loss has multiple etiologies (hormonal, inflammatory, drug‑induced, age‑related, nutritional, autoimmune). A compound effective for one type often fails for another. The Federal Circuit has long held that in unpredictable arts, the enablement requirement is stricter (e.g., In re Fisher, 427 F.2d 833 (CCPA 1970), wherein biological unpredictability requires more enabling disclosure). The person of ordinary skill in the art would not be able to predict, without experimentation, which types of hair loss DMG treats, at what concentrations, via which routes, in which formulations. The specification’s theory of improved microcirculation is too generic to supply the necessary predictability. The specification does not sufficiently describe how the invention achieves prevention across all claimed scenarios.
State of the prior art – The specification acknowledges that there are few effective pharmaceutical treatments for hair loss and that existing treatments are either not effective enough or have side effects. This admission underscores that the person of ordinary skill in the art does not have a well‑developed body of knowledge to fill in the gaps. While DMG is known as an intermediate in glycine biosynthesis, its use for treating a broad spectrum of hair loss is not extensively characterized in the prior art. The prior art does not provide a roadmap, and as such the specification cannot rely on routine skill to rescue under‑disclosure. The field of hair loss prevention is complex, and prior art does not suggest a generalized solution. Without detailed guidance, undue experimentation would be required to achieve the claimed effect.
Level of one of ordinary skill in the art – The person of ordinary skill in the art would likely be a team including a dermatologist, a cosmetic chemist, and a formulation scientist, with knowledge of hair follicle biology, pharmacokinetics of topicals, and clinical trial design for alopecia. Even with that skill, a person of ordinary skill in the art could not practice the full scope of claim 11 without undue experimentation. The person of ordinary skill in the art would know how to formulate topical compositions and run clinical studies, but the specification provides no starting point for which concentrations work for which type of hair loss, which routes of administration (other than topical) are effective, whether DMG alone has efficacy independent of caffeine, what duration of treatment is needed, and how to measure success of treatment and prevention for each type of alopecia. High skill does not excuse the specification’s failure to provide the necessary teaching.
Given the skill level, the specification deficiencies are critical because of the unpredictability of biological systems, wherein even highly skilled researchers cannot reliably extrapolate prevention mechanisms without significant experimental data (e.g., empirical determination of all routes of administration demonstrating efficacy, dose-response data indicating concentration achieving prophylaxis, kinetic/pharmacodynamic profiles detailing onset and duration of protection, endpoint and target engagement/efficacy biomarkers measuring prevention, and patient stratification (e.g., high-risk genotypes data). While a person of ordinary skill in the art could design experiments to test prevention, the claim’s breadth demands open-ended trial-and-error.
Level of predictability in the art – The art of treating hair loss is notoriously unpredictable. As the specification admits, different forms of alopecia have different causes (i.e., androgenetic alopecia- hormonal (androgens); alopecia areata- autoimmune/inflammatory; chemotherapy‑induced- cytotoxic injury to rapidly dividing matrix cells; senescent alopecia- age‑related changes in follicle cycling; and diffuse alopecia- often telogen effluvium from stress or metabolic insult). A person of ordinary skill in the art would have no reasonable expectation that a single compound (DMG) acting via improved microcirculation would successfully treat all these mechanistically distinct conditions. The specification provides no data for any condition other than a general reduction in perceived hair loss in an unspecified subject population using DMG in combination with caffeine. Here, claim 11 covers an enormous array of unpredictable biological scenarios with almost no enabling support.
Amount of direction or guidance provided by the inventor – The specification provides minimal direction for practicing the broad claim. The specification theorizes that DMG improves microcirculation and oxygen turnover in the scalp. This theory is plausible for androgenetic alopecia, but a person of ordinary skill in the art would have no reasonable expectation that improving microcirculation treats inflammatory alopecia areata, chemotherapy‑induced alopecia (where the mechanism is mitotic arrest of rapidly dividing cells), or diffuse alopecia from telogen effluvium. No guidance is given on why DMG would work for these disparate pathologies. In addition, every example of an in vivo effect uses formulations that contain DMG plus caffeine. The specification does not provide a single study showing DMG alone treats hair loss, let alone prevents all types of hair loss.
Claim 11 also has no lower or upper limit on DMG concentration. A person of ordinary skill in the art is not told what dose, what frequency, what duration, or what concentration is required to achieve "treating and/or preventing hair loss." Dependent claim 19 provides a broad range (0.00001%-25.0% by weight), but offers no guidance on which sub‑ranges are effective, let alone for which condition. The claim provides no route of “administering” guidance, wherein a person of ordinary skill in the art has no guidance on whether oral, parenteral, subcutaneous, or other routes work, or what doses would be needed for those routes. No detailed therapeutic protocols (e.g., dosing, treatment schedules, patient selection criteria), necessary to reasonably enable prevention, are provided to guide implementation.
Existence of working examples – The specification provides working examples, but they are narrow relative to the claim scope. All working examples are topical formulations (shampoos, conditioners, emulsions, hair tonics). None demonstrate oral, parenteral, or any other route of administration. All in vivo studies showing efficacy are on formulations containing DMG plus caffeine. There is no working example of a composition containing only DMG or a DMG salt that demonstrates treatment or prevention of hair loss. The in vitro data on HaCaT cells measure cell viability, proliferation, and VEGF expression. While interesting, these are surrogate endpoints, not actual treatment or prevention of hair loss. Increased VEGF in keratinocytes is not guaranteed to translate to clinically meaningful hair retention. This is preliminary cellular data, not clinical data demonstrating the prevention or treatment of hair loss in a subject.
A specification cannot rely on the use of post-filing research to demonstrate enablement for the novel aspects of the claim. The human application studies are for six months, but they all contain caffeine. There are no working examples for treating alopecia areata, chemotherapy‑induced alopecia, diffuse alopecia, or senescent alopecia beyond androgenetic hair loss. The specification lacks concrete data demonstrating prevention. Hypothetical or prophetic examples are insufficient (MPEP 2164.01(a)). The few working examples do not provide a reasonable basis to extrapolate to the vast, uncharted territory of the claims.
Quantity of experimentation needed – The amount of experimentation required to practice the full scope of claim 11 is immense. A person of ordinary skill in the art would be forced to engage in a screening process to determine whether DMG prevents and treats each listed type of hair loss (androgenetic, alopecia areata, chemotherapy‑induced, senescent, diffuse), via each potential route of administration, at each possible concentration (0.00001% to 100% of the composition), in each possible formulation (e.g., shampoos, conditioners, emulsions, tonics, but also oral tablets, injectables, etc.), alone or in combination with countless other optional ingredients. The specification provides no guidance or predictive principles to narrow this inquiry. The person of ordinary skill in the art would be left to conduct extensive clinical studies for each permutation, far exceeding routine experimentation.
Broad functional claims require "full scope" enablement, general principles alone are insufficient for unpredictable arts (Amgen Inc. v. Sanofi, 598 U.S. 594 (2023)), wherein even skilled artisans cannot compensate for missing critical details. The specification’s gaps would require undue experimentation (e.g., years of iterative testing) to achieve the claimed prevention.
In summary, the claim's breadth is immense, the predictability of treating all forms of hair loss with a single compound is low, and the specification provides a very limited number of working examples that do not even demonstrate the claimed outcome can be attributed to DMG alone. Dependent claims 12-14 and 16-23 are included in this rejection because they do not cure the defect noted above. Accordingly, the instant claims do not comply with the enablement requirement of 35 U.S.C. § 112, first paragraph, since to practice the claimed invention a person of ordinary skill in the art would have to engage in undue experimentation, with no assurance of success.
To overcome this rejection, the applicant may amend claim 11 to bring its scope in line with what the specification demonstrably enables (e.g., "A method for cosmetically treating hair loss selected from the group consisting of hereditary hair loss and age-related hair loss in a subject, comprising topically administering a composition consisting essentially of a cosmetically acceptable carrier and 0.1% to 10% by weight of dimethylglycine or a salt thereof, wherein the composition has a pH of 3.0 to 5.9.", in which the narrower claim ties the method to the specific cosmetic indication and types of hair loss mentioned in the objects of the invention, administration is limited to the topical route used in all examples, and by reciting the specific pH and concentration ranges that the specification teaches as critical for stability and efficacy, the invention is the formulation of DMG rather than just mere presence of DMG).
Claim Rejections - 35 USC § 112(b)
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 Applicant regards as his invention.
Claim 14 is 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, regards as the invention.
Claim 14 recites “wherein the composition is a hair and/or skin care composition able to promote metabolism of the scalp and hair.” The phrase “able to promote metabolism” is indefinite because it lacks an objective standard for determining whether a given composition possesses this ability and fails to inform a person of ordinary skill in the art of the scope of the claim with reasonable certainty. The specification does not provide any objective test or measurable parameter for determining whether a given composition possesses this ability (e.g., “increases ATP production by at least [X]% as measured by [Y] assay”).
The term “metabolism” in the context of scalp and hair is undefined, wherein it is unclear whether this refers to cellular respiration, protein synthesis, ATP production, or another unspecified biochemical process. The claim does not specify what metabolic pathway is promoted, what measurable parameter constitutes promotion of metabolism, whether the promotion is biochemical, cellular, follicular, vascular, or cosmetic, or what degree of activity is required. Without an objective standard, the metes and bounds of claim 14 are unclear (see Nautilus, Inc. v. Biosig Instruments, Inc., 572 U.S. 898 (2014)).
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 11-14 and 16-23 are rejected under 35 U.S.C. § 103 as being unpatentable over Albrecht and Mintel (DE10217131A1, published 13 February 2003; hereinafter referred to as “Albrecht”) in view of Taylor et al. (US8883131B2, published 11 November 2014; hereinafter referred to as “Taylor”).
Albrecht teaches a “topically applicable” composition for cosmetic and/or dermatological application comprising specific active substances, wherein the active substances include dimethylglycine (claim 1; in addition, claim 10 explicitly states the composition can be applied topically; see also ¶[0003]), camitine (claim 1) and at least one additive including the preservative phenoxyethanol and various solvents (¶[0014], amongst other conditioning agents, lipid replenishers, stabilizers, rheology modifiers, thickeners disclosed within the specification) for use in providing care/treatment for skin and/or hair (claim 13 and ¶[0030]). Evidentiary reference Schulze et al. (DE-102020125874-A1; published 04 July 2022), by the same assignee as Albrecht (Dr Kurt Wolff GmbH and Co KG) is persuasive evidence that the hair loss treatment utility was inherent in the composition taught by Albrecht.
Albrecht discloses topically-applied dimethylglycine-containing compositions for care in treating the hair and skin (scalp; claims 10 and 13). Evidentiary reference Schulze et al., from the same assignee is concerned with the same overlapping formulation, and explicitly discloses that such dimethylglycine-containing compositions are intended for the purpose of treating hair loss, which is merely inherent to Albrecht's disclosed compositions (see In re Baird, 16 F.3d 380 (Fed. Cir. 1994) and MPEP § 2131 regarding inherency in a reference disclosure of a limitation even if the reference does not explicitly recite a limitation).
Although Schulze et al., it is not prior art due to its publication date, page 3, ¶3, explicitly states the active ingredients for particularly preferred embodiments of the invention is the combination of dimethylglycine or the salts of dimethylglycine with caffeine, wherein in page 3, ¶6, states, “The active ingredient combination of dimethylglycine or a salt of dimethylglycine with caffeine according to the invention shows improved effectiveness in the treatment of hair loss, in particular hereditary and age-related hair loss, than caffeine or dimethylglycine and/or a salt of dimethylglycine alone. The combination of active ingredients increases the microcirculation in the scalp to an unexpected extent and significantly improves the supply of nutrients and oxygen to the hair roots.”. Thus, Schulze et al., is directed towards dimethylglycine-containing compositions the same general purpose of hair and skin (scalp) treatment, explicitly for the specific anti-hair loss purpose (see first eight paragraphs of the specification). A person of ordinary skill in the art reading Albrecht would have recognized this inherent utility, especially when informed by the state of the art. Therefore, the claimed methods are obvious as the inherent and intended use of Albrecht's compositions.
Further, Albrecht teaches a dimethylglycine-containing composition containing camitine, as described above, for the purpose of caring for/treating the hair and skin (which innately includes the skin on the scalp; claims 1 and 13 and ¶[0030]) as a topically applicable pharmaceutical and/or cosmetic composition (¶[0001]).
Albrecht, however, does not explicitly teach the method step of administering the composition to the hair or scalp of a subject. Applying a hair care product to the hair and or scalp would be a logical, intended and obvious use of a composition explicitly described as being for topically applied hair care. Thus, instant claims 12, 13 and 17 are routine and obvious methods of using the composition taught by Albrecht.
Albrecht teaches the dimethylglycine-containing composition, wherein a broadly suitable, effective, and dermatologically acceptable pH for the disclosed topical application compositions is 4.0-8.0 (claim 30), establishing that the pH is an adjustable parameter. The instant claimed pH ranging from 3.0-5.9 significantly overlaps with the 4.0-8.0 range taught by Albrecht.
It would have been obvious to a person of ordinary skill in the art to optimize the pH of the compositions taught by Albrecht to fall within the instant claimed range of 3.0-5.9. A formulator of ordinary skill, seeking to prepare a stable and efficacious topical composition for hair/scalp treatment, would routinely optimize the pH based on well-known formulation principles including compatibility with active ingredients, wherein many common active ingredients (e.g., vitamins, peptides, some acids) are most stable and effective in slightly acidic conditions and the natural pH of a healthy scalp is approximately 4.5-5.5, wherein formulating topical hair treatment compositions within this range is a standard, well-known practice in dermatology and trichology to maintain skin barrier function, reduce irritation, and discourage microbial overgrowth.
Formulating a topical scalp treatment within or near this physiological range to enhance compatibility, reduce irritation, and maintain skin barrier integrity is a standard, well-known practice in dermatological and trichological formulation. Adjusting pH using common formulating agents (e.g., citric acid, sodium hydroxide) to achieve a target within a known, effective range is a matter of routine experimental optimization that does not involve an inventive step. Therefore, in the absence of evidence of criticality or unexpectedly superior results at the claimed pH range from 3.0-4.0 that is not achievable across the broader prior art range of 4.0-8.0, the selection of a pH range from 3.0-5.9 would have been routine and obvious at the time of the invention (see In re Aller, 220 F.2d 454 (CCPA 1955); In re Peterson, 315 F.3d 1325 (Fed. Cir. 2003), 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), rendering instant claim 18 as a routine and obvious optimization of the composition taught by Albrecht.
Albrecht teaches that the active substances, including dimethylglycine can be present in concentrations from 1-55% in particular between 5-30% (¶[0031]) or 0.05-20% (¶[0034]) or wherein methylglycine and/or dimethylglycine is contained in the composition in a concentration of between 0.01-10 wt.% (claim 28 and ¶[0045]), based on the weight of the ready-to-use cosmetic composition, establishing that the concentration of the active ingredients and/or specifically dimethylglycine is an adjustable formulation parameter within a broad suitable concentration range. The instant claimed range of 0.00001-25.0% by weight dimethylglycine and/or a salt of dimethylglycine significantly overlaps with the 0.01-55% range taught by Albrecht.
It would have been obvious to a person of ordinary skill in the art to optimize the weight-based concentration of dimethylglycine in the compositions taught by Albrecht to fall within the instant claimed range of 0.00001-25.0%, wherein the specific lower limit is a trivial variation to the concentration ranges taught by Albrecht that are obvious to achieve through routine optimization. A formulator of ordinary skill would routinely experimentally adjust the concentration of the active ingredients to optimize compatibility and efficacy within the context of the overall formulation.
Formulating a topical scalp treatment within or near a concentration of 0.00001-25.0% by weight dimethylglycine based on the total weight of the composition to achieve a stable, cost-effective and efficacious final composition is a matter of routine experimental optimization that does not involve an inventive step. In the absence of evidence of criticality or unexpectedly superior results at the claimed dimethylglycine concentration range from 0.00001-0.01% by weight that is not achievable across the broader prior art range of 0.01-25.0%, the selection of a concentration range of 0.00001-25.0% by weight dimethylglycine would have been routine and obvious at the time of the invention (see In re Aller, 220 F.2d 454 (CCPA 1955); In re Peterson, 315 F.3d 1325 (Fed. Cir. 2003), 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), rendering instant claim 19 as a routine and obvious optimization of the composition taught by Albrecht.
Albrecht teaches that the compositions containing amphipathic phospholipid surfactants glycero-phosphocholine and/or phosphatidylcholine and or N-acylphosphatidylethanolamine surfactants N-acylethanolamine and/or N-acylphosphatidylethanolamine as active substances (claim 1), wherein active substances can be present in concentrations from 1-55% in particular between 5-30% (¶[0031]), thus encompassing and closely matching the instant claim 20 range of 2-40% by weight surfactants in the composition. Choosing the slightly narrower range of the instant claim from the closely matching and encompassing range taught by the prior art is obvious.
Regarding instant claim 23, a composition ranging in pH from 3.0-5.9, comprising the combination of 0.00001% to 25.0% by weight dimethylglycine and/or a salt of dimethylglycine, camitine, and surfactants in an amount of from 2% to 40% by weight is therefore also obvious based on the teachings of Albrecht, as described above for each specific limitation individually. The combination of these known and conventional features for a hair/scalp treatment composition would have been obvious to one of ordinary skill.
Albrecht teaches the limitations of instant claim 11, as discussed above, from which instant claims 14-16 depend, however does not explicitly teach the specific limitations of instant claims 14-16.
Albrecht teaches a dimethylglycine-containing composition, as described above, for the purpose of caring for/treating the hair and skin (which innately includes the skin on the scalp; claims 1 and 13 and ¶[0030]). Albrecht does not explicitly teach wherein the composition is able to promote metabolism of the hair or scalp.
Taylor teaches, “Having healthy hair and a healthy scalp begins with proper nutritional building blocks. The hair follicle is highly active, and so the metabolic requirements for oxygen, energy and protein synthesis must be met to maintain healthy hair. A reduction of nutrients in, the diet or a reduction of blood supply to the scalp can threaten the delivery of adequate oxygen, glucose and essential nutrients…Topical nutritional application can therefore bypass age related reductions in absorption and microcirculatory reductions, and so directly safeguard the nutritional environment of the hair follicle.” (column 1, lines 37-49), and the formulation of a composition for the treatment of hair loss (Abstract), “…to provide a complete spectrum of hair nutrients, amino acids, and special plant derived nutrients, that play a role in scalp health and the metabolism of the hair follicle, and that support healthy growth of hair. Benefits are delivered directly at the hair root.” (column 1, lines 56-60), which includes the use of amino acids and derivatives thereof as "nutritional" or "metabolic" agents for the hair follicle such as L-arginine (column 2, lines 23 and 51), L-lysine HCL (column 2, line 33) and the methyl donor methyl sulphonyl methane (column 2, lines 24 and 52-54).
Dimethylglycine, the amino acid derivative (i.e., glycine) methyl donor, shares a core amino-acid backbone with arginine and lysine, which are used as nutritional/metabolic agents for hair follicles (comprising scalp skin and hair elements). Thus, substituting or supplementing one amino acid (i.e., arginine or lysine) with a related amino acid derivative (i.e., dimethylglycine) for a similar purpose would be obvious with a reasonable expectation of success in making the change to a person of ordinary skill in the art. In addition to the amino acids in the formulation taught by Taylor, methyl sulphonyl methane (column 2, lines 24 and 52-54) is a source of methyl groups for transmethylation pathways, biochemically contributing to the methylation pool, functionally similar to dimethylglycine contributing primary biological relevance based on the role it plays as a methyl donor in transmethylation reactions.
Thus, Taylor teaches amino acid (i.e., arginine an lysine) and recognized methyl donor, methyl sulphonyl methane, active ingredient formulations stimulating metabolism of the hair follicle for use in topical hair/scalp hair loss treatments. Dimethylglycine is a known, simple derivative of the amino acid glycine and a well-known methyl donor involved in the same biological methylation cycles and one-carbon metabolism. One of ordinary skill in the art, seeking alternative or additional amino acids or their derivatives to provide nutritional or metabolic support to hair follicles or to modulate the methylation status of hair follicle cells to promote hair health and treat hair loss, would have been motivated to substitute, combine or supplement the disclosed amino acids or methyl donor with the structurally different and functionally parallel dimethylglycine. This substitution represents the predictable use/substitution of a known compound, dimethylglycine, for its known property of acting as a metabolic/nutritional agent for treating hair loss, as evidence by Taylor, in a known hair/skin care treatment composition, such as that of Albrecht, directed to the same purpose of treating hair/scalp. Hence, the limitations of instant claims 14 and 15 are obvious over the combined teachings of Albrecht and Taylor.
The invention disclosed by Taylor explicitly states an intended use for the treatment of hair loss and baldness (Abstract), and specifically referencing that the most common form of baldness is a progressive hair thinning condition called androgenic alopecia (column 1, lines 15-18), thus topical application of the composition described by Taylor specifically for alopecia androgenetica hair loss, as per the limitation of instant claim 16, is therefore also obvious over the combined teachings of Albrecht and Taylor.
In summary, it would have been prima facie obvious to one of ordinary skill in the art prior to the instant effective filing date to substitute and/or add the amino acid derivative and methyl donor dimethylglycine to the amino acid or methyl sulphonyl methane methyl donor in the invention taught by Taylor stimulating metabolism of the hair follicle for use in topical hair/scalp hair loss treatments and combine the teachings with that of the invention of Albrecht aimed at formulating stable topical application cosmetic or pharmaceutical compositions compatible with treating subjects with sensitive skin that is inflamed and irritated (see Albrecht ¶[0003]), as treating the hair or scalp in subjects suffering from hair loss or baldness with a formulation causing inflammation, irritation or an allergic reaction may acerbate an already fragile and compromised hair follicle in need of safeguarding the environment (see Taylor column 1, lines 40-49), trauma and stress-related hair loss, and/or render the scalp more prone to infection-associated hair loss (see Taylor column 1, lines 22-28). Thus, one seeking to formulate a method for treating hair loss in a subject comprising topical application of a composition to the hair and/or scalp would be motivated to use combine the hair loss topical compositions taught by Taylor with the teachings of Albrecht for formulating topical compositions compatible with treating subjects with comprised or sensitive skin (such as those suffering from hair loss), with a reasonable expectation of success because both inventions are known for the same purpose of treating the hair or skin.
Response to Arguments
Applicant Arguments/Remarks of the reply, filed 10 April 2026, have been fully considered.
The applicant argues that Albrecht does not disclose the newly adder limitation to claim 11 of treating hair loss because Albrecht is silent on that specific indication. The examiner agrees with the applicant, Albrecht does not expressly disclose treatment or prevention of hair loss. Accordingly, has withdrawn the anticipation by Albrecht rejection under 35 U.S.C. §102(a)(1). However, minimally, the new limitation of amended to claim 11 of treatment and/or prevention of hair loss does not overcome obviousness.
Albrecht discloses topical administration of dimethylglycine-containing compositions to the hair and skin (scalp) for cosmetic/dermatological treatment (claim 13). Treating hair and scalp encompasses the treatment of conditions affecting the hair and scalp, including hair loss. A person of ordinary skill in cosmetic dermatology would have understood that topical hair/scalp treatment compositions reasonably encompass treatment of conditions involving hair thinning, weakened follicles, or excessive shedding. The presently claimed therapeutic indication is therefore an obvious use of a known composition for a closely related condition.
Evidentiary reference Schulze et al., as discussed above, is commonly directed to the same inventive entity and to the subject matter of topical compositions comprising dimethylglycine for application to hair and/or scalp and discloses an inherent purpose of Albrecht's compositions, for the treatment of hair loss. Schulze et al., explicitly teaches that dimethylglycine-containing compositions for hair and skin (scalp) treatment of Albrecht are effective for treating and preventing hair loss, suppling the full scope of utility of Albrecht's compositions. Schulze et al., states the hair loss treatment purpose that is a logical and intended use of the dimethylglycine compositions already disclosed by Albrecht. Albrecht teaches how to formulate stable topical dimethylglycine compositions. Schulze et al., teaches why (i.e., for treating hair loss) and what else (additional active ingredients) can be included. In addition, regarding claim 14, Schulze et al., teaches that the composition promotes metabolism of the hair follicle.
Even if one were to argue that Schulze et al., is not combinable with Albrecht as an evidentiary reference for some reason, Taylor provides independent support for the hair loss treatment limitation and the metabolic promotion limitation. A person of ordinary skill in the art seeking to use Albrecht's dimethylglycine compositions for treating hair loss would be motivated to look to Taylor, which teaches exactly that purpose using related amino acid and methyl donor active ingredients. Dimethylglycine (a methyl donor and glycine derivative) is structurally and functionally analogous to the amino acids (arginine, lysine) and the methyl donor (MSM) taught by Taylor. Substituting or supplementing one known methyl donor or amino acid for another in a composition for the same intended purpose (treating hair loss) would have been obvious with a reasonable expectation of success.
Further, the amendment to claim 11 to add the limitation “wherein treating the hair and scalp comprises treating and/or preventing hair loss”, is not a structural or procedural limitation that distinguishes it over Albrecht, it is merely a statement of intended outcome that is inherent in any method of treating the hair and scalp. Albrecht’s compositions are applied topically to the hair and scalp and thus, any therapeutic or cosmetic benefit that occurs, including prevention of hair loss, is a natural consequence of that administration. Albrecht discloses a method (topical application) for treating hair and scalp (claim 13) using a composition comprising dimethylglycine (claim 1), to a subject (implied). The added phrase “comprising treating and/or preventing hair loss” is not a positive limitation of the method steps, it is a purpose statement that does not alter the procedural steps of the method (see In re Schreiber, 128 F.3d 1473 (Fed. Cir. 1997), addressing wherein the prior art inherently performs the same function).
Even assuming arguendo that Albrecht does not expressly disclose treatment of hair loss, it was well established before the applicant’s effective filing date that topical scalp formulations comprising amino acid derivatives, nutritional actives, circulation-supporting agents, and scalp-compatible acidic pH were routinely used in anti-hair-loss formulations. Albrecht teaches topical dimethylglycine scalp compositions and Taylor teaches topical metabolic support for hair-loss treatment, wherein applying Albrecht’s composition for prevention of hair shedding would have been a predictable and routine extension. The claimed invention therefore represents the predictable use of prior art elements (Albrecht in combination with Taylor) according to established functions (see KSR Int’l Co. v. Teleflex Inc., 550 U.S. 417 (2007)).
The applicant argues that Albrecht does not teach or suggest treating hair loss and that Taylor does not cure the deficiency. The examiner disagrees. Taylor explicitly teaches compositions for treating hair loss using amino acids (arginine, lysine) and methyl donors (methyl sulphonyl methane). Dimethylglycine is a known methyl donor and N-methylated amino acid derivative. One of ordinary skill would have been motivated to substitute DMG for MSM or supplement the amino acids in Taylor’s composition because DMG participates in the same transmethylation pathways (folate-methionine cycle) and has known metabolic effects (see KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398 (2007), wherein it is obvious to try known alternatives in predictable manner).
DMG’s role as a methyl donor in one-carbon metabolism was well-established long before the priority date. Methyl donors are known to support cell proliferation, including keratinocytes (the primary cell type of hair follicles). Taylor teaches that metabolic requirements for oxygen, energy and protein synthesis must be met to maintain healthy hair. Substituting one known methyl donor (MSM) with another known methyl donor (DMG) would have been routine experimentation with a reasonable expectation of success (see In re O’Farrell, 853 F.2d 894 (Fed. Cir. 1988)). The applicant argues that arginine has a guanidinium group absent in DMG, and that lysine increases iron stores. This is irrelevant. The rejection does not rely on structural identity, it relies on functional equivalence as methyl donors and metabolic enhancers. Moreover, the rejection of claim 16 (alopecia androgenetica) is based on Taylor’s explicit disclosure of treating androgenic alopecia, not on DMG’s structural similarity to arginine. The rationale is not structural identity, but predictable functional application in an analogous art.
The applicant relies upon in vitro keratinocyte data (e.g., viability, proliferation, VEGF expression) and in vivo hair shedding (shampoo study) observations as evidence of unexpected results. However, the evidence is not sufficient to overcome the prima facie case. To rebut a prima facie case of obviousness, unexpected results must be commensurate in scope with the claimed invention (see In re Grasselli, 713 F.2d 731 (Fed. Cir. 1983)). The claims broadly encompass 0.00001% to 25% dimethylglycine, numerous salts, many formulation types, numerous optional actives, broad surfactant ranges, and multiple hair loss conditions. The evidence appears directed only to limited experimental embodiments.
In addition, the data do not compare claimed embodiments against Albrecht compositions (e.g., Albrecht’s compositions containing choline, betaine, or carnitine) or Albrecht/Taylor-type formulations, wherein unexpected results require comparison with the closest prior art (see In re Baxter Travenol Labs, 952 F.2d 388 (Fed. Cir. 1991)). Further, the applicant has not demonstrated criticality of the claimed lower concentration limit (DMG concentration 0.00001-25.0%), the claimed pH range (pH 3.0-5.9), the claimed surfactant range (2-40%), and dimethylglycine as opposed to closely related prior art formulations (e.g., Albrecht’s pH 4.0-8.0, DMG 0.01-55%). Routine optimization does not confer patentability. Accordingly, the evidence is presently insufficient to rebut obviousness.
Albrecht expressly teaches topical application for hair and skin. Hair care compositions are necessarily applied to hair and/or scalp. These limitations therefore remain obvious. The applicant’s amendments clarifying “based on the total weight of the composition” merely define reference basis and do not confer patentable distinction as the claimed pH of 3.0-5.9 overlaps Albrecht’s disclosed pH range, the claimed dimethylglycine range substantially overlaps Albrecht, the surfactant range overlaps or is encompassed by Albrecht’s formulation teachings, and claim 23 merely combines known parameters disclosed in Albrecht. Optimization of concentration, pH, and surfactant loading is routine formulation work (see In re Aller, 220 F.2d 454 (CCPA 1955) and In re Peterson, 315 F.3d 1325 (Fed. Cir. 2003)).
Taylor expressly teaches support of hair follicle metabolism and scalp nutritional environment. Accordingly, it would have been obvious to formulate Albrecht’s dimethylglycine compositions as hair/scalp compositions intended to promote scalp and hair metabolism. Claim 14 therefore remains obvious. Taylor expressly discusses androgenic alopecia and hair thinning. The specific recited hair-loss categories therefore remain obvious.
The provisional nonstatutory double patenting rejections over co-pending U.S. applications 18/247,527 and 18/247,542 are maintained. The applicant’s present amendments do not overcome the central basis of the rejection. The co-pending applications claim dimethylglycine-containing compositions for treatment of hair and scalp. The presently pending claims merely recite administering those compositions for their intended purpose. A claim to use of a known composition for its disclosed intended purpose is ordinarily not patentably distinct (see In re Basell Polyolefine Italia S.P.A., 547 F.3d 1371 (Fed. Cir. 2008)).
The newly added “treating and/or preventing hair loss” limitation does not presently establish patentable distinction because hair-loss treatment remains an obvious and closely related intended use of the disclosed topical hair/scalp compositions. Accordingly, the provisional obviousness-type double patenting rejections are maintained. The applicant is advised to file a terminal disclaimer in each co-pending application in compliance with 37 C.F.R. §1.321(c) or amend the claims to establish patentable distinction.
To overcome these rejections, the applicant may amend the claims to introduce limitations not taught or suggested by the combination of Albrecht and Taylor (e.g., unexpected results, a critical parameter not disclosed, or a new, non-obvious mechanism), submit objective evidence of non-obviousness, such as unexpected synergistic effects, failure of others, or unexpected superior properties (see MPEP § 716); argue that a person of ordinary skill in the art would not have been motivated to combine the references, providing technical reasoning specific to the art; or argue that a person of ordinary skill in the art would not have had a reasonable expectation of success in using Albrecht's compositions for treating hair loss. The applicant is reminded that secondary considerations, such as unexpected results, must be supported by evidence commensurate in scope with the claimed invention and compared against the closest prior art to demonstrate unexpectedly superior results.
Conclusion
No claims are allowed.
The applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 (87 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 REBECCA L. SCOTLAND whose telephone number is (571) 272-2979. The examiner can normally be reached M-F 9:00 am to 5:00 pm EST.
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/RL Scotland/
Examiner, Art Unit 1615
/Robert A Wax/Supervisory Patent Examiner, Art Unit 1615
Prosecution Insights