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 .
Specification Objection
The title of the invention is objected to under 37 CFR § 1.72. The title of the invention is not descriptive. The title “Composition for Treating Hair and Scalp” suggest that the claims are directed towards a composition, however all of the claims (11-23) are method of treatment claims and fails to clearly and accurately reflect the subject matter and functional aspects of the invention. A new title is required that is clearly indicative of the invention to which the claims are directed. Failure to respond to the objection within the statutory period is required to avoid abandonment.
The following title is suggested: “Method for Treating Hair and Scalp Using Dimethylglycine Compositions”. This title mirrors the language of independent claim 11, is more precise, technically accurate, and better informs the public as to the core invention.
Claims Status
Claims 11-23 are pending and under current examination in this application. Amendment to the Claims and Remarks filed 16 October 2023 are acknowledged. Claims 1-10 are cancelled and new claims 11-23 are added and are supported by the originally-filed disclosure.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 02 November 2023, is acknowledged and considered by the Examiner.
Claim Objections
Claim 14 is objected to because of the following informalities:
Claim 14 recites, “…wherein the composition is a care composition…”, wherein a “care composition” is ambiguous because it does not have a clear, objective meaning in the context of the claims, therefore a person of ordinary skill in the art cannot ascertain the metes and bounds of the claimed invention with reasonable certainty. However, the specification provides adequate guidance to one of ordinary skill in the art regarding “hair care compositions”.
The Applicant is advised to amend the claim to more clearly state the meaning of a “care composition” (e.g., “…wherein the composition is a hair and/or skin care composition…”) to avoid ambiguity as to the metes and bounds of what is claimed.
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.
Claims 16, 19, 20 and 23 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, regards as the invention.
Claim 16 recites, “the hair loss”, as it is not previously introduced in claim 11 from which it depends and therefore there is insufficient antecedent basis for this limitation in the claim (see MPEP 2173.05(e)), rendering the scope of the claims unclear. To overcome this rejection, the Applicant may amend the claim to correct the defect (e.g., " The method of claim 11, wherein the composition comprises treating and/or preventing hair loss and the hair loss is selected from the group consisting of…” or “The method of claim 15, wherein the hair loss is selected from the group consisting of…”).
Claims 19, 20 and 23 recite a component at a specified % by weight, however, the claims fail to specify what the % weight is relative to, leading to ambiguity in the scope of the claims. The claims do not clarify whether the % weight of the component is relative to the total weight of the composition or another undefined reference. Without an explicit reference, the % weight could be interpreted in multiple ways, rendering the claim scope unclear. Claims must be "definite" to inform the public of the invention's boundaries with reasonable certainty (Nautilus, Inc. v. Biosig Instruments, Inc., 572 U.S. 898 (2014)) and provide clear meaning to a skilled artisan (see MPEP 2173.02). To overcome this rejection, the Applicant may amend the claims to specify the reference basis for the % weight (e.g., “0.00001% to 25.0% by weight dimethylglycine and/or a salt of dimethylglycine, based on the total weight of the composition” and “surfactants in an amount of from 2% to 40% by weight, based on the total weight of the composition”) or provide a definition in Specification explicitly clarifying the basis for % weight for the claims.
Claim Rejections - 35 USC § 102
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 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.
Claims 11, 21 and 22 are rejected under 35 U.S.C. § 102(a)(1) as being anticipated by Albrecht and Mintel (DE10217131A1, published 13 February 2003; hereinafter referred to as “Albrecht”).
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]).
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 11-13, 17-20 and 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”).
Albrecht teaches the limitations of instant claim 11, as discussed above, from which instant claims 12, 13, 17-20 and 23 depend, however does not explicitly teach the specific limitations of instant claims 12, 13, 17-20 and 23.
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.
Claims 11, and 14-16 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 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.
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.
Conclusion
No claims are allowed.
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