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
The listing of claims filed 26 November 2025 have been examined. Claims 1-18 are pending.
Claim Objections
Claims 1, 3, 7, 11-15, and 17 are objected to because of the following informalities:
Claim 1 recites, “one or more selected from potassium, zinc, calcium, rubidium”. The phrase is missing a noun after “selected from” (e.g., “one or more metals selected from”). Alternatively, the claim could be written as, for example, “one or more selected from the group consisting of potassium, zinc, calcium, and rubidium.” As currently written, it is grammatically incomplete. Appropriate correction is required.
In claim 3, potassium, zinc, calcium, and rubidium are unnecessarily capitalized. They should be presented in lower case when used as common chemical names in the body of a claim. Appropriate correction is advised.
In claims 7 and 17, “cyclohexylphenole” appears to be a typographical error for “cyclohexylphenol.” The applicant should also consider revising “cannabidiol acid,” “cannabigerol acid,” “cannabidivarin acid,” “tetrahydrocannabinol acid,” and “tetrahydrocannabivarin acid” to their conventional chemical names (i.e., cannabidiolic acid, cannabigerolic acid, cannabidivarinic acid, tetrahydrocannabinolic acid, and tetrahydrocannabivarinic acid, respectively). The expression “Δ8 tetrahydrocannabinol” should preferably be rendered consistently (e.g., “Δ8-tetrahydrocannabinol”).
It is advised that the specification also be revised, as appropriate. In particular, ¶[0010] and related passages use “cyclohexylphenole,” which the applicant should clarify and correct if “cyclohexylphenol” was intended. The same paragraph contains the grammatically misplaced statement “the pharmaceutical agent is CBD, THC or combinations thereof.” Specification ¶[0044] expressly identifies Δ-3-carene, whereas ¶[0045] uses “delta-s-carene.” The applicant should reconcile these inconsistent designations. The specification also contains “Cannabis refers to any and all of these plant varieties,” which appears to contain a typographical error and should be clarified. The extended terpene list contains additional apparent typographical/nomenclature errors such as “bomeol acetate,” “bomyl acetate,” “linolool,” and “cinnameldehyde.” The applicant should review and correct these terms where appropriate, without introducing new matter.
In claim 11, “gel” is repeated twice (“gel, emulsion, gel”). The claim should be amended to remove the redundancy. In addition, the plural “pharmaceuticals” is recited and should likely be “pharmaceutical” (as a dosage form to parallel the other physical product forms) or “pharmaceutical composition”, and “combination thereof” should preferably be “a combination thereof” or “combinations thereof”. Regarding the recitation of “essence ointment”, it appears that a comma has been omitted given the detailed description expressly lists “essence, ointment” separately. If a comma has been omitted, “ointment” and “ointments” would then be redundant and one should be removed. The applicant should make the appropriate corrections.
It is advised that the specification also be revised, as appropriate. In particular, the Summary contains the phrases “essence ointment,” duplicated “gel,” both “ointment” and “ointments,” and “pharmaceuticals” among physical dosage forms. The Detailed Description elsewhere separately identifies “essence, ointment,” supporting correction of at least the missing punctuation.
Claim 12 recites, “physical exfoliating agent” which should preferably be plural to parallel the preceding classes (i.e., “physical exfoliating agents”). The semicolon before “and mixtures thereof” should be a comma. Appropriate correct is advised.
Claim 13 recites, “providing skin in need of treatment” which is awkward and would be more clearly stated as, for example, “providing a subject having skin in need of treatment” or “selecting a subject with skin in need of treatment.” Also, “applying topically to skin” should be “applying topically to the skin.”
In claim 14, it is unclear if “treatment of prevention” is intended or the claim in intended to read “treatment or prevention”. The applicant should make the correction, if appropriate, to read on the intended meaning. In addition, “improvement of skin appearance decreased by menopause” is grammatically awkward. The “increase in and/or preventing loss of skin elasticity” lacks grammatical parallelism and should preferably be “increase in and/or prevention of loss of….”.
Claim 15 recites, “wherein the skin suffers from”, which should be “wherein the skin has” or “wherein the subject has.”
Claim Rejections - 35 USC § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. § 112(a):
(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 13-18 are rejected under 35 U.S.C. § 112(a) or 35 U.S.C. § 112 (pre-AIA ), first paragraph, while being enabling for certain species and uses, as failing to comply with the enablement requirement to use the full scope of the combinations of cannabis extracts/cannabinoids, metal components, concentrations, doses, treatment regimens, skin-benefit endpoints, and disease-treatment or prevention endpoints encompassed by claims 13-18. The claims contain subject matter which was not described in 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 invention.
Claims 13-18 are rejected under 35 U.S.C. § 112(a) because the specification, while being enabling for certain species and uses within the scope of the claims, does not reasonably provide enablement commensurate with the full scope of the claimed methods. In particular, the specification, considered together with knowledge in the art, reasonably enables preparation and topical administration of conventional cannabis-containing and mineral-containing topical formulations, including art-established embodiments employing known topical cannabinoids such as CBD and/or THC for known dermatological or inflammatory uses and known K/Zn/Ca/Rb topical systems for recognized skin benefits.
The specification does not, however, enable a person of ordinary skill to use the full scope of the substantially broader combinations of cannabis extracts/cannabinoids, metal components, concentrations, doses, treatment regimens, skin-benefit endpoints, and disease-treatment or prevention endpoints encompassed by claims 13-18 without undue experimentation. This is a scope-of-enablement rejection. The examiner does not take the position that no embodiment within claims 13-18 is enabled, nor does the examiner question, for purposes of this rejection, the enablement of the particular art-established embodiments relied upon in the rejections under 35 U.S.C. § 103. Rather, the deficiency is that the claims extend substantially beyond those enabled embodiments to functionally defined subject matter for which the specification does not provide representative examples, a demonstrated structure-function or composition-function relationship, or other guidance reasonably permitting the skilled artisan to extrapolate across the full claimed scope (see MPEP § 2164, § 2164.06, and § 2166; In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988); Amgen Inc. v. Sanofi, 598 U.S. 594, 610-14 (2023).
For purposes of this rejection, and notwithstanding the separate issues under 35 U.S.C. § 112(b), “effective amount” is interpreted as an amount sufficient to produce the skin benefit or treatment effect required by the claim in which the term appears. The claims have been evaluated by the eight Wands factors (see In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988) to determine enablement as detailed below:
Breadth of the Claims
Claim 13 is not limited to a particular cannabis extract, cannabinoid species, metal species or combination, concentration, dose, vehicle, or particular skin benefit. It encompasses one or more of potassium, zinc, calcium, and rubidium together with one or more cannabis extracts, each in an effective amount, applied topically to provide a benefit to human skin.
The specification itself describes a very broad universe of cannabis-derived components, including numerous cannabinoids and terpenes and the use of differing extracts, combinations, and synthetic compounds. Claims 13 and 17 therefore encompass materially different chemical species rather than a narrowly circumscribed class whose members are shown to possess a common relevant biological activity.
Claim 14 further encompasses numerous distinct treatment and prevention endpoints, including, inter alia, signs of aging, collagen or procollagen synthesis, barrier repair, hyperpigmentation, inflammation, sebum regulation, hydration, elasticity, and cellulite. Claim 15 encompasses treatment of biologically distinct dermatologic conditions including eczema, psoriasis, dermatitis, folliculitis, rosacea, acne, and neoplastic growths. Claim 18 further encompasses cannabinoid amounts extending approximately from 0.5 mg to 1000 mg per dose. Accordingly, the claimed scope extends substantially beyond the particular cannabinoid, mineral, dose, and dermatological embodiments for which operability is established by the specification or was already known in the art.
Nature of the invention and
Predictability in the art
The relevant enablement issue is not whether a skilled topical formulator can physically prepare a cream, lotion, gel, ointment, or related topical formulation containing the recited ingredients. Conventional topical formulation technology and selection of customary carriers and excipients are within the ordinary level of skill, and the Examiner does not rely upon an inability to formulate the claimed ingredients as the basis for this rejection. The issue instead concerns the claimed use of the resulting compositions at effective amounts to obtain the broad range of biological, cosmetic, therapeutic, and prophylactic effects encompassed by claims 13-18.
The physiological effects at issue are not shown to be interchangeable across the claimed genus. Activity of a particular CBD- or THC-containing topical formulation against an inflammatory condition does not establish that every other cannabis extract, cannabinoid, synthetic cannabinoid, or terpene encompassed by the claims will provide the same activity when combined with every claimed metal embodiment. Likewise, effectiveness against psoriasis or another inflammatory skin condition does not itself establish effectiveness against neoplastic growths; hydration does not establish increased collagen synthesis; and anti-inflammatory activity does not itself establish prevention of hyperpigmentation, regulation of sebum, reduction of cellulite, or the other biologically distinct endpoints encompassed by the claims. The specification does not disclose a demonstrated structure-activity, composition-activity, or other predictive relationship establishing that these materially different compounds, mixtures, doses, and endpoints can be treated as members of a common functional class for purposes of the claimed methods (see In re Vaeck, 947 F.2d 488, 495-96, 20 USPQ2d 1438, 1444-45 (Fed. Cir. 1991)).
State of the Prior Art
The state of the art establishes that certain embodiments falling within the claims were within ordinary skill. For example, the prior art relied upon elsewhere in this Office action establishes known topical cannabis embodiments employing CBD and/or THC for dermatological and inflammatory applications and known topical K/Zn/Ca/Rb systems for skin-benefit applications. Those teachings support the conclusion that at least these particular embodiments and closely corresponding conventional topical uses are enabled.
The prior art also supports particular cannabinoid dosage embodiments relied upon in the § 103 rejection of claim 18. The Examiner therefore does not contend that a skilled artisan would have been unable to prepare or use those particular prior-art-established embodiments. This conclusion does not, however, establish enablement of the materially broader scope sought by claims 13-18. Knowledge that particular cannabinoids, particular mineral systems, particular doses, or particular dermatological treatments work does not supply a general teaching that every materially different member encompassed by the claims will work for the many different functions and diseases recited. The enablement question is whether the skilled artisan could practice the entire claimed scope, not merely whether one or several species within that scope can be practiced.
This distinction is also consistent with the obviousness rejections. The § 103 rejections rely upon particular embodiments for which the cited prior art supplies the necessary teachings, motivation, and reasonable expectation of success. The present § 112(a) rejection addresses instead the substantially broader subject matter remaining within the claims for which no corresponding teaching or reasonable basis for extrapolation is provided. Thus, the Examiner is not taking the inconsistent positions that the same embodiment both would and would not have been within the ability of the skilled artisan to practice.
Level of Ordinary Skill in the Art
A person of ordinary skill in the topical pharmaceutical or cosmetic arts would have substantial knowledge concerning conventional topical carriers, emulsions, excipients, cannabinoids, and dermatological formulation. That high level of skill weighs in favor of enablement of the conventional formulation aspects and of art-established cannabinoid/mineral embodiments. The level of ordinary skill does not, however, substitute for a teaching reasonably permitting extrapolation from those known embodiments to all of the materially different cannabis species, extracts, concentrations, metal combinations, doses, disease states, and biological mechanisms encompassed by the claims.
Amount of Direction and Guidance Provided
The specification provides substantial guidance regarding formulation ingredients, extraction techniques, cannabinoid and terpene identities, vehicles, excipients, oils, emulsions, and topical product forms. This information is sufficient to guide preparation of topical compositions and is not the basis for the present rejection. Materially less guidance is provided for selecting, throughout the full claimed scope, which cannabis extract or cannabinoid, which metal or combination of metals, which respective concentrations, which cannabinoid dose, and which administration regimen will provide the particular biological or therapeutic result required by a given embodiment of claims 13-18.
The specification does not set forth a generally applicable screening criterion, structure-function relationship, dose-selection rule, or other principle from which a skilled artisan could reasonably determine that materially different members throughout the claimed genus will achieve the claimed effects. Instead, outside the particular embodiments for which activity was already established or reasonably predictable from the state of the art, the disclosure leaves the artisan to determine effectiveness empirically.
Existence of Working Examples
The absence of working examples is not, by itself, the basis for this rejection. It is considered together with the breadth of the claims, unpredictability of the biological endpoints, and limited guidance for extrapolation across the claimed genus.
The specification refers to improvement in healing following Retin-A or laser repair but does not provide sufficiently detailed experimental information identifying the relevant claimed metal/cannabis composition, quantities, protocol, controls, dose-response relationship, or other information from which a skilled artisan could derive a general principle applicable to the numerous independent therapeutic and biological endpoints encompassed by claims 14 and 15. Thus, even accepting the disclosed result, the disclosure does not demonstrate that the result is representative of the substantially broader claimed genus.
Quantity and Nature of Experimentation Needed
Some experimentation, including conventional formulation adjustment and ordinary dose optimization within an established therapeutic system, is permissible and may be routine (see In re Wands, 858 F.2d at 737; In re Angstadt, 537 F.2d 498, 502-04, 190 USPQ 214, 217-19 (CCPA 1976). The examiner therefore does not rely merely upon the fact that experiments would have to be performed. The difficulty arises from the scope and character of the experimentation necessary to extend the limited art-established embodiments to the entire claimed genus. For embodiments not reasonably predictable from known topical cannabinoid or mineral systems, the skilled artisan would have to select among materially different cannabis extracts or cannabinoid species, metal identities and combinations, concentrations, vehicles, doses, and treatment regimens and then determine experimentally whether each selected combination achieves the particular claimed function.
Depending upon the claimed endpoint, such investigation could require materially different assays or models for collagen or procollagen synthesis, barrier function, pigmentation, inflammatory activity, sebum production, hydration, elasticity, psoriasis, rosacea, acne, other inflammatory disorders, prevention endpoints, or neoplastic growths. The problem is therefore not merely optimization of a known operative embodiment. It is the repeated determination of which members of a broad, functionally defined genus are operative for biologically different claimed uses without a disclosed principle that permits the artisan to extrapolate reliably from the enabled embodiments to the remaining scope.
This is analogous in relevant principle to In re Colianni, 561 F.2d 220, 222-24, 195 USPQ 150, 152-53 (CCPA 1977), in which the disclosure did not adequately teach how to select parameters sufficient to obtain the claimed result, and to the full-scope principle reaffirmed in Amgen Inc. v. Sanofi, 598 U.S. 594 (2023). The Supreme Court explained that a specification need not separately describe how to make and use every embodiment within a claimed class, but it must enable the skilled artisan to make and use the claimed class without requiring the artisan to engage in an unreasonable program of trial and error to determine which members satisfy the claimed functional requirements.
Application to the Dependent Claims
For claim 14, the deficiency concerns the extension of the claimed method from particular known skin effects to the complete set of distinct treatment and prevention endpoints encompassed by the claim, in combination with the broad cannabis and metal genera inherited from claim 13. The Examiner does not contend that every individual skin-benefit embodiment is itself unknown; rather, the disclosure does not provide a basis for extending the full claimed cannabis/metal genus across all of the recited functional endpoints.
For claim 15, the deficiency is particularly pronounced because the claim encompasses treatment of materially different dermatologic diseases. The fact that particular prior-art topical cannabis embodiments were useful for psoriasis or inflammatory skin conditions establishes enablement of those particular embodiments, not treatment throughout a genus that also encompasses eczema, folliculitis, rosacea, acne, and neoplastic growths using the full range of compositions encompassed by claim 13.
Claim 16’s requirement for potassium, zinc, calcium, and rubidium narrows the mineral component but does not restrict the cannabis-extract genus, dose, treatment regimen, or skin-benefit function sufficiently to make the disclosure commensurate with the full claimed scope.
For claim 17, known topical use of CBD and/or THC supplies enabled species falling within the claim. The Examiner does not question enablement of those art-established species for their known topical uses. Claim 17, however, expressly encompasses a substantially broader group of chemically distinct cannabinoids and related compounds without a disclosed basis establishing that the entire genus shares the required functional activity in the claimed mineral/cannabis methods.
For claim 18, the art establishes particular cannabinoid dosage embodiments, including dosage ranges relied upon in the § 103 rejection. Those known dosage embodiments are not the subject of the present enablement concern. The claim nevertheless extends to a much broader cannabinoid dosage scope, including approximately 0.5 mg to 1000 mg per dose, while inheriting the broad cannabis-extract, metal, and functional limitations of claim 13. The specification does not provide guidance commensurate with determining effective doses throughout that full range for the materially different compounds and treatment endpoints encompassed by the claim.
In summary, weighing the Wands factors as a whole, the specification and knowledge in the art enable preparation and use of particular embodiments within claims 13-18, including conventional topical formulations and particular art-established cannabinoid, mineral, dose, and dermatological embodiments. Accordingly, the examiner does not contend that the claims are wholly non-enabled.
The claims, however, seek materially broader protection encompassing combinations of cannabis extracts and cannabinoids, metal constituents, concentrations, doses, treatment regimens, biological functions, disease states, and prevention endpoints for which the specification does not provide representative disclosure or a predictive principle reasonably permitting extrapolation from the enabled embodiments. Practicing that remaining scope would require an unreasonable amount of empirical identification rather than routine optimization of embodiments already known to be operative. Accordingly, the disclosure is not commensurate with the full scope of claims 13-18, and are rejected for scope of enablement under 35 U.S.C. § 112(a).
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 3-5, 7-10, 13, and 15-18 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 3 recites “0.01-5% Potassium, 0.01-5% Zinc, 0.01-1% Calcium, and 0.01-1% Rubidium,” but does not identify the basis on which the percentages are calculated. In a chemical composition, a percentage can represent, for example, weight percent, volume percent, weight/volume percent, mole percent, or another compositional basis. Different bases may encompass materially different compositions.
The ambiguity is particularly evident because claim 4 and the specification separately describe the metal concentrations expressly in weight % based on the total weight of the composition, whereas the formulation corresponding to claim 3 merely recites percentages without a basis. Accordingly, one of ordinary skill cannot determine with reasonable certainty which compositions satisfy the numerical limitations of claim 3 (see Nautilus v. Biosig, 572 U.S. 898 (2014)).
Claim 4 recites that potassium, zinc, calcium, and rubidium are present “in an individual concentration of from about 0.001 weight % to about 5 weight % …; from about 0.01 weight % to about 3 weight % …; and from about 0.1 weight % to about 2 weight %, or about 1 weight %….”. It is unclear whether each metal must simultaneously satisfy all three ranges, thereby effectively limiting each metal to their intersection, the three ranges are alternative embodiments, the latter ranges are merely preferred embodiments of the broader range, or “about 1 weight %” is an alternative only to 0.1-2 weight % or to all preceding ranges.
The specification repeats substantially the same ambiguous syntax rather than resolving it. MPEP § 2173.05(d) specifically instructs that including a broad range together with a preferred or narrower range in one claim can render a claim indefinite where it is unclear whether the narrower range constitutes a limitation. The applicant is required to amend the claim to specify the intended relationship among the ranges.
Claim 5 recites “potassium and zinc; or potassium and zinc and calcium or rubidium.” The absence of express grouping renders the alternative indefinite because it is unclear whether the claim requires potassium and zinc; potassium, zinc, and calcium; potassium, zinc, and rubidium; or under another grammatical reading, potassium/zinc/calcium or rubidium. The specification uses substantially the same expression and does not resolve the intended logical grouping. The applicant should clarify, if intended, by expressly enumerating the alternatives (e.g., “potassium and zinc; potassium, zinc, and calcium; or potassium, zinc, and rubidium”).
At the conclusion of the recited cannabinoid list, claim 7 states “the pharmaceutical agent is CBD, THC or combinations thereof.” Neither claim 1 nor claim 7 previously introduces “a pharmaceutical agent.” It is therefore unclear to what subject matter “the pharmaceutical agent” refers, since it lacks proper antecedent basis (see MPEP § 2173.05(e)). Furthermore, the clause is appended directly to the list following a comma, making it unclear whether it is intended as another member of the list, a separate limitation on the cannabis extract, a limitation requiring the “pharmaceutical agent” to be CBD/THC, or redundant explanatory language. Accordingly, claim 7 fails to particularly point out and distinctly claim the invention. The corresponding Summary disclosure repeats the same malformed clause.
In claim 8, the phrase “the cannabis extract further comprises one or more secondary cannabinoids, beta-myrcene, linalool, nerolidol, …” fails to state whether “one or more” modifies only “secondary cannabinoids,” in which case each subsequently listed terpene would appear mandatory, or the entire list, such that any one of the listed cannabinoids/terpenes is sufficient. The specification elsewhere uses materially clearer wording (i.e., “the terpene fraction may comprise one or more of beta-myrcene, linalool, nerolidol…”), demonstrating that the present claim wording does not unambiguously express the same selection.
Second, claim 8 identifies “delta-s-carene.” The specification identifies Δ-3-carene in ¶[0044] but “delta-s-carene” in ¶[0045]. PubChem recognizes 3-carene as a defined monoterpene. The specification therefore does not permit the examiner to determine whether “delta-s-carene” is intended to identify Δ-3-carene or some different compound. Thus, claim 8 is indefinite.
Claim 9 states that the composition comprises “one or more vitamins selected from Vitamin B9 …; and Vitamin B12….” The use of “one or more selected from” ordinarily indicates alternatives, while “and” indicates that both B9 and B12 are required. The claim therefore fails to clearly state whether one vitamin or both vitamins must be present. Second, claim 9 recites broad B9/B12 ranges and thereafter states “more preferably” narrower ranges in the same claim. It is unclear whether the “more preferably” ranges limit the claimed composition or merely express a preference (see MPEP § 2173.05(d), wherein preferences in claims may render a claim indefinite where it is unclear whether the narrower/preferred limitation defines the scope of the claim).
Third, claim 9 defines the quantity of B9 and B12 in micrograms “per dose,” but claim 9 is a composition claim and neither claim 1 nor claim 9 defines the quantity of composition corresponding to one dose. The specification repeats these “per dose” amounts but separately states that therapeutically effective doses may vary according to body weight and that timing and duration are to be determined by clinical research protocols. It therefore does not provide a fixed construction of “dose” that resolves the claim boundary. Accordingly, claim 9 fails to particularly point out and distinctly claim the invention.
Claim 10 defines the cannabis-extract content as various milligram quantities of cannabinoid “per dose.” Claim 10 is a composition claim, however, and neither claim 1 nor claim 10 specifies a unit-dose amount of the composition. For example, the claim does not identify whether a “dose” is a gram of cream, a particular volume, a single package, an amount applied per unit surface area, or an amount selected by the user.
The specification reproduces the same cannabinoid-per-dose ranges but states that effective doses may vary with body weight and that timing and duration depend on clinical research protocols. Thus, the specification does not provide an objective dose denominator by which infringement of this composition claim could be determined. Thus, claim 10 is indefinite.
Claim 13 requires both an “effective amount” of one or more of potassium, zinc, calcium, and rubidium and an “effective amount” of one or more cannabis extracts, but identifies the required function only as “providing a benefit to human skin.” The disclosure identifies numerous materially different possible effects, including wound healing, anti-aging activity, collagen synthesis, moisturization, pigmentation changes, reduction of inflammation, regulation of sebum, treatment of psoriasis and rosacea, and treatment of neoplastic skin conditions. The specification does not identify an objective threshold common to these disparate endpoints for determining when a quantity of the metal component or cannabis component becomes an “effective amount.”
MPEP § 2173.05(c) recognizes that “effective amount” is not per se indefinite, but directs that the controlling question is whether a skilled artisan can determine the amount from the disclosure. The phrase has been held indefinite where the required function is not adequately stated and multiple effects can be implied.
Claim 15 specifies a condition from which the skin suffers, but does not expressly state that the “benefit” of claim 13 must be treatment of that particular condition. Claims 16-18 likewise do not cure the ambiguity as to the functional threshold. Accordingly, claims 15-18 inherit the indefiniteness of claim 13. In contrast, claim 14 more specifically defines “the skin benefit” by an enumerated list and therefore provides greater functional specificity than claim 13 alone.
Claim 16 is further as indefinite. Claim 16 recites, “The method of claim 13, comprising potassium, zinc, calcium, and rubidium.” A method normally comprises acts or steps, whereas the recited potassium, zinc, calcium, and rubidium are components of the topical composition. It is therefore unclear whether claim 16 requires an additional method step or, as appears more likely, intends to require that the composition recited in claim 13 comprise all four metals. The applicant is required to clarify the intended limitation.
Claim 17 is further rejected as indefinite for the same lack of antecedent basis described above for claim 7. The phrase “the pharmaceutical agent is CBD, THC or combinations thereof” does not refer back to any previously introduced “pharmaceutical agent,” and its relationship to the preceding Markush list is unclear.
Claim 18 is further rejected as indefinite as well because “per dose” lacks an objective claim boundary. Although claim 18 is a method claim rather than a composition claim, the claimed method merely recites applying the composition topically and does not specify what constitutes one dose (e.g., amount applied at one administration, application area, formulation mass/volume, frequency, or another defined dose unit). The specification states that therapeutically effective doses vary with body weight and that timing and duration are to be determined by clinical research protocols, rather than providing an objective definition applicable across the claimed method.
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 1, 6-8, 11, and 12 are rejected under 35 U.S.C. § 102(a)(1) as being anticipated by Sinai et al. (US20180042890A1; published 15 February 2018, hereinafter “Sinai”).
A reference anticipates when each and every limitation of the claim is disclosed expressly or inherently and the limitations are arranged or combined as required by the claim (see In re Gleave, 560 F.3d 1331, 1334 (Fed. Cir. 2009); MPEP § 2152). For purposes of examination under the broadest reasonable interpretation (“BRI”), the term “potassium” in instant claim 1 is interpreted to encompass potassium present in a potassium-containing compound or salt disposed in the carrier, including the potassium necessarily present in dipotassium glycyrrhizate, absent an express definition in the specification limiting “potassium” to elemental potassium metal or a narrower specified chemical form. Claims are given their broadest reasonable interpretation consistent with the specification (see MPEP § 2111).
Regarding instant claim 1, Sinai discloses a pharmaceutical topical composition comprising a carrier and a cannabis extract. In particular, Example 1 and ¶[0217]-[0219] disclose an exemplified topical cream formulation containing cannabis oil for treatment of psoriasis and other inflammatory dermatological conditions. The formulation includes a conventional topical carrier comprising, inter alia, purified water, glyceryl stearate/PEG-100 stearate, glycerin, cetyl alcohol, petrolatum, and other cosmetically/pharmaceutically acceptable carrier ingredients. The same formulation expressly contains dipotassium glycyrrhizate, cannabis oil, and β-caryophyllene, and the cannabis oil in the cream comprises about 3% THC and about 3% CBD.
Sinai independently recites in claim 21 a single pharmaceutical topical composition having a carrier containing dipotassium glycyrrhizate and β-caryophyllene and further containing cannabis oil comprising CBD and THC. Sinai ¶[0076]-[0080] expressly characterize the material as a cannabis extract and specifically describe a topical cream containing a cannabis oil extract.
Under the BRI set forth above, dipotassium glycyrrhizate necessarily contains potassium and therefore meets the limitation requiring “one or more selected from potassium, zinc, calcium, rubidium” disposed in the carrier. Accordingly, Sinai discloses, in the arrangement required by instant claim 1 (i.e., a topical composition, a cosmetically or pharmaceutically acceptable carrier, potassium disposed therein, and a cannabis extract disposed therein). Instant claim 1 is therefore anticipated.
Regarding instant claim 6, Sinai further discloses that the cannabis-containing topical formulation contains cannabinoids CBD and THC, as well as β-caryophyllene (claim 1). Sinai ¶[0219] identifies approximately 3% THC and approximately 3% CBD in the topical cream, while Table 1 expressly identifies β-caryophyllene as “a terpene in cannabis.” Because instant claim 6 requires that the cannabis extract be a cannabinoid, a terpene, or a terpenoid compound, the express disclosure of CBD and THC as cannabinoids, and independently β-caryophyllene as a cannabis terpene, satisfies the limitation. Instant claim 6 is therefore anticipated.
Regarding instant claim 7, Sinai expressly discloses cannabis oil containing CBD and THC, including a topical formulation having about 3% THC and about 3% CBD (claim 3; see also ¶[0076], ¶[0079]-[0080], ¶[0092], ¶[0218]-[0219]). Instant claim 7 recites “one or more selected from” an alternative list that expressly includes CBD, THC, or combinations thereof. Disclosure of CBD and/or THC is sufficient to meet the claimed alternative. Instant claim 7 is therefore anticipated.
Regarding instant claim 8, Sinai expressly discloses β-caryophyllene as an active ingredient of the cannabis-containing topical cream (claim 17) and identifies β-caryophyllene as a terpene in cannabis (Table 1; see also claim 4). Sinai ¶[0219] and Table 1 specify β-caryophyllene at 0.5%. Sinai claim 4 similarly expressly recites about 0.5% β-caryophyllene. Because β-caryophyllene is one of the alternatives expressly recited in instant claim 8, Sinai meets the additional limitation of instant claim 8. Instant claim 8 is therefore anticipated.
Regarding instant claim 11, Sinai expressly describes the exemplified composition as a topical cream formulation (claim 17). Sinai ¶[0218]-[0219] state that the topical cream contains cannabis oil and β-caryophyllene, and Table 1 includes dipotassium glycyrrhizate in that formulation. Sinai also expressly teaches pharmaceutical topical dosage forms selected from cream, ointment, lotion, foam, film, and transdermal patch (¶[0036] and claim 17). Since instant claim 11 requires only that the claimed composition have one of the recited forms, including a cream, lotion, ointment, or gel, the expressly exemplified cream meets the limitation. Instant claim 11 is therefore anticipated.
Regarding instant claim 12, the same Example 1 topical cannabis cream of Sinai contains multiple skin-benefit agents falling expressly within the claimed classes. Sinai ¶[0219] states that the formulation is enriched in anti-irritation and anti-inflammatory agents and in skin-moistening and nourishing agents. Table 1 identifies, among other ingredients, glycerin as a humectant, petrolatum as an occlusive/emollient agent, tocopheryl acetate as an antioxidant, allantoin as an anti-irritation agent, and salicylic acid as a keratolytic agent. Sinai also expressly lists anti-irritation agents, antioxidants, humectants, and emollient agents as components of the topical composition (¶[0021] and claim 2). Because instant claim 12 requires only at least one skin-benefit agent selected from its recited classes, Sinai meets the limitation. Instant claim 12 is therefore anticipated.
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.
In the alternative, claims 1, 6-8, 11, and 12 are rejected under 35 U.S.C. § 103 as being unpatentable over Sinai et al. (US20180042890A1; published 15 February 2018, hereinafter “Sinai”) in view of Pilant (US20170202769A1; published 20 July 2017).
This alternative rejection is provided in the event it is determined that the “potassium” limitation of instant claim 1 is not expressly or inherently met under § 102 by the potassium necessarily present in Sinai’s dipotassium glycyrrhizate.
Sinai teaches the complete topical-cannabis portion of the claimed composition, including the topical carrier, cannabis extract, CBD/THC, β-caryophyllene, topical cream dosage form, and additional skin-benefit agents, as described above. Pilant expressly teaches the missing mineral limitation in virtually the same topical formulation context. Pilant claim 1 recites a topical composition for keratinous tissue comprising a cosmetically or pharmaceutically acceptable carrier and one or more selected from potassium, zinc, calcium, and rubidium disposed in the carrier.
Thus, It would have been prima facie obvious to one of ordinary skill in the art prior to the instant effective filing date to incorporate one or more of Pilant’s known K/Zn/Ca/Rb skin-care components into the known cannabis-containing topical carrier of Sinai to obtain the respective known skin benefits of the components while retaining the anti-inflammatory/dermatological benefits of the cannabis extract. Both references concern topical compositions applied to human skin and employ conventional cosmetically/pharmaceutically acceptable carriers. The modification amounts to combining known topical-composition components according to known methods to obtain their predictable functions (see In re Kerkhoven, 626 F.2d 846, 850 (CCPA 1980); MPEP § 2143; MPEP § 2144.06).
For dependent claims 6-8, 11, and 12, Sinai itself expressly supplies the respective CBD/THC, β-caryophyllene, cream, and skin-benefit-agent limitations discussed in the 35 U.S.C. § 102 rejection above. Thus, those dependent claims would likewise have been obvious over the combined teachings of Sinai and Pilant.
Claims 1, 2-5 and 13-17 are rejected under 35 U.S.C. § 103 as being unpatentable over Sinai et al. (US20180042890A1; published 15 February 2018, hereinafter “Sinai”), in view of Pilant (US20170202769A1; published 20 July 2017).
Sinai (or in the alternative in view of Pilant) teaches the limitations of instant claim 1, as described above, from which instant claims 2-5 depend, however does not explicitly teach the specific limitations of instant claims 2-5.
As explained above, Sinai teaches a cannabis-containing pharmaceutical topical composition and topical treatment of human skin, while Pilant teaches the same type of cosmetically/pharmaceutically acceptable topical carrier containing K, Zn, Ca, and/or Rb for providing benefits to human skin. It would have been obvious to combine these known topical active systems to obtain their known and complementary skin-care effects, with a reasonable expectation that the resulting conventional topical composition would remain suitable for application to skin. This is a predictable combination of known topical composition elements under KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398 (2007) (see also MPEP § 2143).
Regarding instant claim 2, Pilant expressly discloses in claim 2 a composition comprising potassium, zinc, calcium, and rubidium, and further identifies preferred alternatives comprising potassium and zinc, and potassium and zinc together with calcium or rubidium. Pilant ¶[0010] provides the same combinations. Instant claim 2 is written as a series of alternative metal combinations joined by “or.” Pilant’s express four-metal K/Zn/Ca/Rb composition, K/Zn composition, and K/Zn/Ca or K/Zn/Rb compositions each fall within alternatives expressly recited in instant claim 2. Sinai supplies the cannabis-extract limitation of instant claim 1. Accordingly, instant claim 2 would have been obvious.
Regarding instant claim 3, Pilant expressly teach a four-metal composition having 0.01-5% potassium, 0.01-5% zinc, 0-1% calcium, and 0-1% rubidium (¶[0009] and claim 4). The presently claimed potassium and zinc ranges are identical. The claimed 0.01-1% calcium and 0.01-1% rubidium ranges lie within Pilant’s respective 0-1% ranges, while Pilant expressly identifies calcium and rubidium as components of the four-metal composition.
Thus, the prior-art range encompassing a narrower claimed range establishes a prima facie case of obviousness (see In re Peterson, 315 F.3d 1325, 1330 (Fed. Cir. 2003); MPEP § 2144.05). Moreover, where the general conditions are disclosed in the prior art, routine determination of an optimum or workable range is ordinarily obvious absent evidence of criticality or unexpected results (see In re Aller, 220 F.2d 454, 456 (CCPA 1955)). It therefore would have been obvious to select a nonzero calcium and rubidium amount falling within Pilant’s expressly disclosed 0-1% range, including 0.01-1%, in the combined Sinai/Pilant topical cannabis composition. Thus, instant claim 3 would have been obvious.
Regarding instant claim 4, Pilant claim 4 expressly discloses potassium, zinc, calcium, and rubidium at an individual concentration of about 0.001-5 wt.%, about 0.01-3 wt.%, about 0.1-2 wt.%, or about 1 wt.%, based upon the total weight of the composition. These concentration limitations correspond essentially verbatim to instant claim 4. Sinai supplies the cannabis extract required by instant claim 1. Accordingly, instant claim 4 would have been obvious.
Regarding instant claim 5, Pilant expressly teaches potassium and zinc, and alternatively potassium and zinc together with calcium or rubidium (claim 2 and ¶[0010]). These are the precise alternative metal combinations recited in instant claim 5. Sinai supplies the cannabis extract of instant claim 1. Instant claim 5 therefore would have been obvious.
The obviousness rejections below for claims 13-17 and claim 18, addressed further in a separate section, are directed to particular embodiments falling within the scope of claims 13-18 for which the cited prior art supplies the relevant compositions, uses, and/or dosage teachings and supports a reasonable expectation of success, based on the rejection under 35 U.S.C. §112(a) is a scope-of-enablement rejection directed to the materially broader subject matter also encompassed by claims 13-18, as detailed above. A claim encompassing an obvious species is unpatentable under §103 even though the claim may additionally encompass other embodiments that have not been shown obvious by the particular prior-art combination relied upon herein.
Regarding instant claim 13, Sinai expressly teaches a method for treatment of skin by providing a topical cannabis composition and administering the composition topically at a therapeutically effective dosage (¶[0060]-[0062] and claim 22). Sinai further demonstrates topical treatment of human skin and inflammatory dermatological disease with the cannabis-containing formulation (¶[0076]-[0085] and ¶[0218]-[0219]).
Pilant ¶[0011] expressly teaches a method for providing a benefit to human skin comprising providing skin in need of treatment and applying topically to the skin a composition comprising an effective amount of one or more selected from potassium, zinc, calcium, and rubidium in a cosmetically acceptable vehicle. Accordingly, Pilant supplies essentially verbatim the mineral/effective-amount portion of instant claim 13, while Sinai supplies the effective topical cannabis-extract treatment.
A person of ordinary skill in the art would have been motivated to incorporate Pilant's known topical mineral system into Sinai's known cannabis-containing topical formulation because both references teach active-containing compositions intended for topical application to human skin using conventional cosmetically or pharmaceutically acceptable carriers. One of ordinary skill in the art would have reasonably expected that the resulting composition could be formulated and topically administered and would retain at least the known skin-benefit activity associated with the expressly taught embodiments of the respective components. This conclusion is limited to the art-established embodiments upon which this rejection relies and does not require a finding that every metal/cannabis combination or every possible skin benefit encompassed by instant claim 13 would have been predictable. Because instant claim 13 encompasses these expressly taught embodiments, instant claim 13 would have been obvious.
Regarding claim 14, Pilant expressly teaches that the skin benefit obtainable by its K/Zn/Ca/Rb topical method may include treatment or prevention of signs of skin aging, treatment/prevention of fine lines or wrinkles, reduction of pore size, improved thickness, plumpness and tautness, improved suppleness and softness, improved tone, radiance and clarity, improved texture/retexturization, improved barrier repair/function, improved skin contours, restored luster/brightness, replenishment of nutrients, improvement of menopause-related appearance, improved moisturization/hydration, improved elasticity/resiliency, increased procollagen/collagen synthesis, treatment/prevention of sagging or atrophy, exfoliation/reduced dryness, treatment/prevention of hyperpigmentation, treatment/prevention of inflammation, treatment/prevention of excess sebum, and treatment/prevention of cellulite (¶[0011]). In addition, Sinai independently expressly teaches reduction of skin inflammation by its topical cannabis formulation (¶[0032]-[0035], ¶[0080]-[0084], and claims 13-16).
Thus, the prior art expressly establishes at least the inflammation embodiment of instant claim 14 and Pilant additionally identifies substantially the other claimed skin-benefit alternatives for its mineral topical system. A person of ordinary skill would therefore have had reason to combine the known topical cannabis formulation of Sinai with Pilant's known mineral-containing topical composition and a reasonable expectation of obtaining at least an expressly taught skin-benefit embodiment, including reduction or treatment of inflammation. Because instant claim 14 recites the skin benefits as alternatives, establishment of an obvious embodiment falling within one such alternative is sufficient to render the claim unpatentable. The rejection does not depend upon a finding that every composition encompassed by instant claim 14 would predictably produce every listed skin benefit.
Regarding instant claim 15, Sinai expressly teaches the topical treatment of psoriasis with cannabis-containing topical formulations, wherein ¶[0076]-[0080] describe a cannabis-extract topical cream for psoriasis, and ¶[0080] reports treatment of the principal symptoms of psoriasis. Claims 14 and 22 likewise concern psoriasis/inflammatory-skin treatment. Because psoriasis is expressly one of the alternative skin conditions recited in instant claim 15, Sinai supplies the additional psoriasis disease limitation, in combination with Pilant's known topical mineral system (i.e., K/Zn/Ca/Rb component). Thus, the obviousness determination as to instant claim 15 does not depend upon predictability of treatment of acne, neoplastic growths, or any other separately recited disease embodiment.
Regarding instant claim 16, Pilant claim 2 expressly teaches a composition comprising potassium, zinc, calcium, and rubidium. Sinai supplies the topical cannabis-extract treatment of instant claim 13. The four-metal limitation of instant claim 16 is therefore expressly taught by Pilant, and thus, instant claim 16 would have been obvious.
Regarding instant claim 17, Sinai expressly teaches cannabis extracts comprising CBD and THC, including a topical cream having about 3% CBD and about 3% THC. (claim 3, see also ¶[0076], ¶[0079]-[0080], ¶[0092], ¶[0219]). Because instant claim 17 requires only “one or more selected from” a list that expressly includes CBD and THC, the additional cannabis-species limitation is directly taught by Sinai. Pilant supplies the effective mineral limitation of instant claim 13. Accordingly, the rejection of instant claim 17 is based on the expressly taught CBD and/or THC species falling within the broader genus of instant claim 17.
Claims 1 and 9 are rejected under 35 U.S.C. § 103 as being unpatentable over Sinai et al. (US20180042890A1; published 15 February 2018, hereinafter “Sinai”), in view of Akmenkalns (US20200069573A1; published 05 March 2020), in further view of Nijhawan (US20190307826A1; published 10 October 2019).
Sinai (or in the alternative in view of Pilant) teaches the limitations of instant claim 1, as described above, from which instant claim 9 depends, however does not explicitly teach the specific limitations of instant claims 9.
Regarding claim 9, Sinai teaches the topical potassium/cannabis composition of instant claim 1 for the reasons set forth above but does not expressly require folate and Vitamin B12 in the amounts presently claimed.
Akmenkalns is directed expressly to a topical multi-vitamin composition administered to the skin. Akmenkalns ¶[0007], ¶[0010], and ¶[0011] explain topical delivery of vitamins/minerals through a transdermal carrier and expressly state that the disclosed amounts are presented on a per-dosage basis (i.e., amount per dose of the composition). Akmenkalns teaches vitamin B9 in ranges of 65-1000 mcg and 65-650 mcg, including specifically 300 mcg per dose (¶[0029]). Akmenkalns teaches vitamin B12 in a range of 0.4 mcg-1.1 mg, including specifically 1 mg (1000 mcg) per dose (¶[0030]). Instant claim 9 places 300 mcg B9 and 1 mg B12 together in the same topical multi-vitamin composition. Both amounts fall within the broad B9 and B12 ranges taught by Akmenkalns.
Nijhawan further removes any possible issue concerning the narrower “more preferably” language of instant claim 9. Nijhawan claims 7 and 8 expressly disclose vitamin B9 from about 25-2000 mcg per dose and Vitamin B12 from about 250-2000 mcg per dose; and vitamin B9 from about 250-400 mcg per dose and Vitamin B12 from about 450-550 mcg per dose. These are the exact broad and preferred ranges recited in instant claim 9. Nijhawan also expressly combines the B vitamins with cannabis in a pharmaceutical composition, thereby confirming the art-recognized compatibility of cannabis and the claimed vitamins.
Thus, it would have been prima facie obvious to one of ordinary skill in the art prior to the instant effective filing date to add the known topically deliverable B9/B12 components of Akmenkalns to Sinai’s known cannabis topical composition, particularly in view of Nijhawan’s express teaching of pharmaceutical compositions containing cannabis together with B9 and B12. Akmenkalns establishes that B9 and B12 can be incorporated into and delivered from a topical carrier, while Nijhawan identifies the very dosage ranges claimed. The combination therefore represents application of known topical and pharmaceutical formulation teachings according to their established functions with a reasonable expectation of success (see MPEP § 2143). Instant claim 9 therefore would have been obvious.
Claims 1 and 10 are rejected under 35 U.S.C. § 103 as being unpatentable over Sinai et al. (US20180042890A1; published 15 February 2018, hereinafter “Sinai”), in view of Nijhawan (US20190307826A1; published 10 October 2019).
Sinai (or in the alternative in view of Pilant) teaches the limitations of instant claim 1, as described above, from which instant claim 10 depends, however does not explicitly teach the specific limitations of instant claims 10.
Regarding instant claim 10, Sinai teaches the topical cannabis composition of parent claim 1 and teaches therapeutic administration of CBD and THC in defined amounts. Claim 23, for example, teaches administration of CBD/THC active ingredient in amounts up to about 30 mg per day, and the reference expressly treats the topical formulation as a therapeutically dosed pharmaceutical composition.
Nijhawan ¶[0030] and claims 11-12 expressly disclose cannabis comprising about 1-30 mg cannabinoid per dose, and preferably about 2.5-10 mg cannabinoid per dose. Those two ranges are recited as alternatives in instant claim 10. Thus, it would have been prima facie obvious to one of ordinary skill in the art prior to the instant effective filing date to employ these known therapeutically useful cannabinoid-per-dose quantities in Sinai’s known CBD/THC topical cannabis composition. Sinai itself teaches therapeutic topical cannabinoid dosing up to about 30 mg, while Nijhawan identifies the claimed per-dose loading ranges. Selection of a known therapeutic cannabinoid amount for a known cannabinoid-containing pharmaceutical formulation would have constituted routine dosage optimization yielding the expected cannabinoid effect (see In re Aller, 220 F.2d at 456; In re Peterson, 315 F.3d at 1330; MPEP § 2144.05).
Claims 13 and 18 are rejected under 35 U.S.C. § 103 as being unpatentable over Sinai et al. (US20180042890A1; published 15 February 2018, hereinafter “Sinai”), in view of Pilant (US20170202769A1; published 20 July 2017), in further view of Nijhawan (US20190307826A1; published 10 October 2019).
Sinai, in view of Pilant, teaches the limitations of instant claim 13, as described above, from which instant claim 18 depends, however does not explicitly teach the specific limitations of instant claims 18.
Regarding claim 18, the combination of Sinai and Pilant teaches the complete method of parent claim 13 for the reasons stated above, Pilant teaches providing skin in need of treatment and topically administering an effective amount of K/Zn/Ca/Rb in an acceptable vehicle, while Sinai teaches topically administering an effective amount of cannabis extract/CBD/THC for treatment of human skin. Nijhawan further teach cannabis comprising about 1-30 mg cannabinoid per dose and about 2.5-10 mg cannabinoid per dose (¶[0030] and claims 11-12). These are two of the dosage alternatives recited in instant claim 18.
It would have been prima facie obvious to one of ordinary skill in the art prior to the instant effective filing date to employ these known cannabinoid dose amounts when carrying out the topical skin-treatment method rendered obvious by Sinai and Pilant. The art already taught topical therapeutic cannabinoid administration, including amounts up to approximately 30 mg in Sinai, and Nijhawan expressly provides the approximately 2.5-10 mg cannabinoid-per-dose ranges, which constitute the recited alternatives within instant claim 18.
In view of Sinai's teaching of therapeutic topical CBD/THC administration, a person of ordinary skill in the art would have had a reasonable expectation that employing these particular art-established cannabinoid dosage ranges with the known CBD/THC topical embodiment would retain the known pharmacological activity of the cannabinoid component. Because these dosage ranges fall within instant claim 18, instant claim 18 encompasses an obvious embodiment. The rejection does not depend upon a determination that the entire approximately 0.5-1000 mg/dose scope, for every cannabis extract, metal combination, and skin-treatment endpoint encompassed by the claim, would have been predictable or routinely optimizable.
It is noted for the record, that Rotunda (US20200352849A1; published 12 November 2020) is considered cumulative/corroborative of the state of the art and is not necessary to establish the prima facie case of obviousness set forth above. The reference further provides evidence that, before the instant effective filing date, it was known to incorporate CBD into conventional topical therapeutic and cosmetic formulations, including creams, ointments, lotions, gels, anti-inflammatory products, and zinc-containing topical products. Accordingly, Rotunda provides additional support for the articulated motivation to incorporate a cannabis-derived active into a known topical skin-care composition and for a reasonable expectation that such incorporation would have been successful. The reference is cited as corroborative evidence and is not relied upon to cure any otherwise missing claim limitation unless expressly stated.
Claim Rejections – Nonstatutory Double Patenting
The following is a nonstatutory double patenting rejection based on the judicially created doctrine grounded in public policy that prevents an unjustified or improper timewise extension of the right to exclude granted by a patent and prevents possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but an examined application claim is not patentably distinct from a reference patent claim because the examined claim would have been anticipated by, or would have been obvious over, the reference claim (see In re Berg, 140 F.3d 1428, 1431-35 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 1052-53 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 892-93 (Fed. Cir. 1985); MPEP §804).
The proper inquiry is first to construe the claims of the application and the claims of the reference patent, identify their differences, and then determine whether those differences render the inventions patentably distinct see (Pfizer, Inc. v. Teva Pharmaceuticals USA, Inc., 518 F.3d 1353, 1363 (Fed. Cir. 2008); MPEP §804).
A reference patent’s specification is not prior art merely by virtue of being the specification of the double-patenting reference and is not relied upon as such. Rather, the portions of the specification describing embodiments falling within the scope of the issued claims and the utilities of the claimed compositions are considered for the limited purpose permitted by In re Vogel, 422 F.2d 438, 441-42 (CCPA 1970), Sun Pharmaceutical Industries, Ltd. v. Eli Lilly & Co., 611 F.3d 1381, 1386-88 (Fed. Cir. 2010), AbbVie Inc. v. Kennedy Institute of Rheumatology Trust, 764 F.3d 1366 (Fed. Cir. 2014), and MPEP §804. Any secondary reference relied upon in an obviousness-type double-patenting analysis must independently qualify as prior art (MPEP §804).
Claims 1-8 and 11-17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5, 10, 12, and 13 of US patent No. 11,160,745 B2 (reference patent), in view of Sinai et al. (US20180042890A1; published 15 February 2018, hereinafter “Sinai”). Although the claims at issue are not identical, they are not patentably distinct from each other for the reasons outlined below.
The instant application and the reference patent name the same inventor, Gregory P. Pilant. Because the instant application has the later filing date, the ordinary one-way test is applicable, whether the invention presently claimed would have been an obvious variation of the invention claimed in the reference patent (see MPEP §804).
The rejection is not based on treating the unclaimed disclosure of the reference patent as prior art, and its specification is considered only insofar as permitted under In re Vogel, 422 F.2d 438, 441-42 (CCPA 1970), Sun Pharmaceutical Industries, Ltd. v. Eli Lilly & Co., 611 F.3d 1381, 1386-88 (Fed. Cir. 2010), AbbVie Inc. v. Kennedy Institute of Rheumatology Trust, 764 F.3d 1366 (Fed. Cir. 2014), and MPEP §804 to construe the issued claims and identify the utilities of embodiments falling within the scope of those claims.
Regarding the secondary references relied upon in an obviousness-type double-patenting analysis, Sinai was published 15 February 2018, before the 27 November 2023 effective filing date of the instant claimed invention, and thus, qualify as prior art. The independently qualifying prior-art reference provides the additional cannabis, cannabinoid, terpene, vitamin, and dosage teachings used in the obviousness analysis.
Scope of the reference patent claims
Issued claim 1 of the reference patent claims a topical composition for application to keratinous tissue comprising a cosmetically or pharmaceutically acceptable carrier; about 0.001-5 wt.% individually of potassium, zinc, calcium, and rubidium, or about 0.001-5 wt.% individually of potassium, zinc, and rubidium; and one or more specified peptides. Issued claims 2 and 3 expressly claim, respectively, the four-metal K/Zn/Ca/Rb embodiment and the K/Zn/Rb embodiment. Issued claim 4 recites the narrower 0.01-3 wt.%, 0.1-2 wt.%, and about 1 wt.% four-metal ranges. Issued claim 5 recites 0.01-5% K, 0.01-5% Zn, 0.01-1% Ca, and 0.01-1% Rb. Issued claim 10 recites lotion, cream, essence ointment, gel, emulsion, pack, cosmetic liquid, ointment, pharmaceutical, or stick forms. Issued claim 13 recites essentially the same skin-benefit-agent genus appearing in present claim 12.
The issued claims therefore establish that the patented invention already encompasses the same keratinous-tissue topical architecture, cosmetically/pharmaceutically acceptable carrier, potassium/zinc/calcium/rubidium system, specific metal combinations, specific metal concentration ranges, topical physical forms, and additional skin-benefit-agent classes now recited in the instant application. The primary difference is that reference patent requires one or more peptides, whereas the presently examined claims require one or more cannabis extracts. That difference does not require removal of the peptide from the patented composition. The present composition claims employ the open-ended transition “comprising” and therefore permit the presence of the peptides required by the reference patent. Thus, adding a cannabis extract to a composition satisfying the issued claims of the reference patent results in a composition falling within the scope of the present claims while preserving every element of the patented composition.
Scope of the secondary reference
Sinai teaches that cannabis-derived active ingredients were known for incorporation into conventional pharmaceutical topical compositions before the instant effective filing date. In particular, Sinai teaches a pharmaceutical topical carrier incorporating cannabis oil containing CBD and THC and β-caryophyllene (claim 1). It specifically discloses topical formulation contains CBD/THC cannabis extract and β-caryophyllene and is provided as a cream or other conventional topical dosage form (¶[0036]). The reference teaches anti-inflammatory and anti-proliferative activity of the cannabis-containing topical formulation and expressly identifies treatment of inflammatory skin disorders including psoriasis (¶[0031]- [0037]).
It therefore would have been prima facie obvious to one of ordinary skill in the topical pharmaceutical/cosmetic arts to incorporate the known topical cannabis extract of Sinai into the topical skin-care compositions claimed in the reference patent to provide the additional known anti-inflammatory and dermatological effects associated with the cannabis active.
The motivation does not depend upon hindsight. Both teachings concern application of active-containing pharmaceutically/cosmetically acceptable compositions directly to human skin, and Sinai expressly demonstrates that CBD/THC cannabis extract can be incorporated into conventional creams and related topical vehicles and retain biological activity. One of ordinary skill would have reasonably expected success because the proposed modification merely adds a known topical skin active to the already-claimed topical carrier rather than changing the underlying delivery route, dosage-form technology, or metal constituents.
Rejection of claims 1-8 and 11-17
Regarding instant claim 1, issued claim 1 of the reference patent claims the same fundamental topical composition architecture (i.e., a composition for application to keratinous tissue comprising a cosmetically or pharmaceutically acceptable carrier, potassium/zinc/calcium/rubidium disposed in the carrier, and an additional biologically active peptide component). Sinai teaches incorporating cannabis oil comprising CBD/THC into a pharmaceutical topical carrier for skin application (claim 1).
Thus, it would have been prima facie obvious to add the known cannabis skin active of Sinai to the patented topical composition to obtain the known dermatological and anti-inflammatory effects of the cannabis component. The peptide required by the issued patent claim 1 need not be removed because present claim 1 is open-ended and does not exclude peptides. The resulting composition contains the patented carrier/metal/peptide system together with cannabis extract and therefore satisfies every limitation of instant claim 1. Instant claim 1 therefore not patentably distinct from the invention claimed in the reference patent in view of Sinai.
Regarding instant claim 2, issued claim 2 of the reference patent expressly requires potassium, zinc, calcium, and rubidium, and issued claim 3 expressly requires potassium, zinc, and rubidium. Both combinations are expressly encompassed by the alternatives of present claim 2. Sinai supplies the known cannabis-extract addition for the reasons discussed with respect to instant claim 1. Accordingly, selection of the presently claimed metal combination does not distinguish instant claim 2 from the patented invention, and it is not patentably distinct.
Regarding instant claim 3, issued claim 5 of the reference patent expressly claims 0.01-5% potassium, 0.01-5% zinc, 0.01-1% calcium, and 0.01-1% rubidium. Those numerical limitations correspond directly to the metal limitations of instant claim 3. Thus, the only material additional limitation is cannabis extract inherited from instant claim 1, which would have been obvious to add for the reasons provided above. Instant claim 3 is therefore not patentably distinct.
Regarding instant claim 4, issued claim 1 of the reference patent claims the four metals individually at approximately 0.001-5 wt.%, while issued claim 4 expressly claims approximately 0.01-3 wt.%, approximately 0.1-2 wt.%, and approximately 1 wt.% for the four metals. The concentrations of instant claim 4 therefore corresponds essentially directly to the concentrations already patented. Addition of the known topical cannabis component would have been obvious in view of Sinai. Instant claim 4 is not patentably distinct.
Regarding instant claim 5, the K/Zn/Rb alternative expressly encompassed by instant claim 5 falls within issued claim 1 and is separately recited in issued claim 3 of the reference patent. Sinai supplies the cannabis-extract limitation (claim 1). Accordingly, instant claim 5 is not patentably distinct.
Regarding instant claim 6, the patented composition structure is taught by issued claim 1 of the reference patent. Sinai expressly teaches CBD and THC cannabis extracts and further teaches β-caryophyllene as a cannabis terpene in a topical skin formulation. CBD and THC are cannabinoids, while β-caryophyllene provides a terpene embodiment (claim 1). Thus, the additional limitation that the cannabis extract be a cannabinoid, terpene, or terpenoid would have been an obvious selection from the expressly taught topical cannabis components. Thus, instant claim 6 is not patentably distinct.
Regarding instant claim 7, Sinai expressly teaches topical formulations containing CBD and THC, including formulations having about 3% CBD and about 3% THC (claim 1 and 3). Because instant claim 7 expressly includes CBD, THC, and combinations thereof among its alternatives, the additional species limitation is directly suggested by Sinai. The underlying metal/carrier composition remains that claimed in the reference patent. Instant claim 7 therefore does not define a patentably distinct invention.
Regarding instant claim 8, Sinai expressly teaches incorporation of β-caryophyllene into the cannabis-containing topical formulation, including approximately 0.5% β-caryophyllene (claims 1 and 4). To the extent instant claim 8 is interpreted, under its broadest reasonable interpretation, as requiring at least one member of the recited secondary-cannabinoid/terpene list, β-caryophyllene directly satisfies that alternative. Any separate uncertainty regarding the grammatical scope of instant claim 8 is addressed under 35 U.S.C. §112(b) and does not confer patentable distinction over the combination. Instant claim 8 is not patentably distinct.
Regarding instant claim 11, issued claim 10 of the reference patent already expressly claims the patented composition in the form of a lotion, cream, essence ointment, gel, emulsion, pack, cosmetic liquid, ointment, pharmaceutical, or stick. These forms substantially overlap the alternatives of instant claim 11. Sinai independently demonstrates cannabis-containing creams, ointments, lotions and related topical forms (¶[0036]). Accordingly, instant claim 11 does not distinguish the instant invention from the patented composition as modified by the known cannabis topical active.
Regarding instant claim 12, issued claim 13 of the reference patent expressly claims the patented composition further containing at least one skin-benefit agent selected from a genus including astringents, antioxidants, free-radical scavengers, anti-acne agents, antimicrobials, antifungals, chelating agents, anti-aging agents, anti-wrinkle agents, analgesics, skin-lightening agents, skin-conditioning agents, anti-irritants, anti-inflammatories, anti-cellulite agents, humectants, emollients, sunscreens, exfoliating agents, self-tanning agents, and biologically active peptides. Instant claim 12 recites substantially the same list. Sinai supplies the cannabis limitation inherited from instant claim 1. Accordingly, instant claim 12 is essentially directed to the previously patented skin-benefit-agent embodiment with the predictable addition of a known cannabis topical active and is not patentably distinct.
Although the reference patent is issued only composition claims, its disclosure pertaining directly to uses of those claimed compositions is properly considered in assessing whether the present method claims are patentably distinct from the claimed composition invention. MPEP §804 permits consideration of those portions of the reference specification supporting the reference claims and permits consideration of the disclosed utility of the claimed subject matter in determining double patenting.
The reference patent specification expressly states that the metal/peptide composition falling within issued claim 1 is topically applied to skin in need of treatment to provide a benefit to human skin (col. 3, ll. 27-28). The specification further identifies essentially the same skin-benefit list now appearing in instant claim 14 (col. 3, ll. 34-60). It also expressly describes use of the claimed metal/peptide composition for treatment of rosacea (col. 13, ll. 29-42). Thus, these portions of the disclosure are not relied upon as separate prior art, they establish the disclosed uses and utilities of embodiments falling squarely within the issued composition claims.
Regarding instant claim 13, issued claim 1 of the reference patent claims the metal-containing topical composition. The specification expressly teaches using that claimed composition by providing skin in need of treatment, topically applying the composition, employing an effective amount of potassium, zinc, calcium, rubidium, or combinations thereof, and providing a benefit to the skin (col. 13, l. 53-col. 14, l. 6). The language and utility substantially correspond to instant claim 13 except for the additional requirement of cannabis extract. Sinai teaches administering a cannabis-containing topical composition to human skin to obtain anti-inflammatory and dermatological benefits. Thus, it would have been prima facie obvious to employ the known cannabis active in carrying out the expressly disclosed topical use of the patented composition, with a reasonable expectation of achieving the known dermatological effects of cannabis. Instant claim 13 therefore merely recites a disclosed use of the patented composition as predictably modified by addition of a known topical cannabis active and is not patentably distinct.
Regarding instant claim 14, the specification of the reference patent expressly identifies as benefits of the claimed metal/peptide topical composition substantially the same list presently recited, including treatment or prevention of signs of aging, fine lines and wrinkles, reduction of pore size, improvements in skin thickness, plumpness and tautness, suppleness and softness, tone and radiance, texture, barrier function, hydration, elasticity, collagen/procollagen synthesis, sagging, dryness, hyperpigmentation, inflammation, excess sebum, and cellulite (col. 3, ll. 40-60). Sinai supplies the known topical cannabis modification. Instant claim 14 therefore claims the same disclosed skin benefits of the patented composition after the obvious addition of a known topical cannabis ingredient and is not patentably distinct.
Regarding instant claim 15, the specification of the reference patent expressly describes the claimed K/Zn/Ca/Rb-plus-peptide composition for treatment of rosacea (col. 13, ll. 40-43). Rosacea is expressly one of the alternative conditions recited in instant claim 15. Sinai independently demonstrates topical cannabis treatment of inflammatory skin conditions, including psoriasis (claim 14). Thus, applying the predictably modified patented composition to rosacea-affected skin does not define a patentably distinct method. Thus, instant claim 15 is rejected.
Regarding instant claim 16, issued claim 2 of the reference patent expressly requires the four-metal combination potassium, zinc, calcium, and rubidium. The patent specification teaches topical administration of such claimed compositions to provide a benefit to human skin, and Sinai provides the obvious cannabis addition. Accordingly, instant claim 16 does not define a patentably distinct invention.
Regarding instant claim 17, Sinai expressly teaches the topical use of CBD and THC as cannabis-derived actives (claim 1). Because CBD and THC are expressly among the alternatives recited in instant claim 17, the additional limitation would have been obvious when carrying out the method of instant claim 13 with the predictably modified patented topical composition. Thus, instant claim 17 is not patentably distinct.
A timely terminal disclaimer may potentially overcome a nonstatutory double-patenting rejection where the requirements of 37 CFR 1.321(c), including the applicable common-ownership requirement, are satisfied. The filing of a terminal disclaimer alone does not constitute a complete reply, a request for reconsideration is also required (see MPEP § 804 and § 1490).
Claims 1, 9, 10, 13, and 18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5, 10, 12, and 13 of US patent No. 11,160,745 B2 (reference patent), in view of Sinai et al. (US20180042890A1; published 15 February 2018, hereinafter “Sinai”), and further in view of Nijhawan (US20190307826A1; published 10 October 2019). Although the claims at issue are not identical, they are not patentably distinct from each other for the reasons outlined below.
The instant application and reference patent name the same inventor, Gregory P. Pilant. Because the instant application has the later filing date, the ordinary one-way test is applicable, whether the invention presently claimed would have been an obvious variation of the invention claimed in reference patent (see MPEP §804).
The rejection is not based on treating the unclaimed disclosure of the reference patent as prior art, and its specification is considered only insofar as permitted under In re Vogel, 422 F.2d 438, 441-42 (CCPA 1970), Sun Pharmaceutical Industries, Ltd. v. Eli Lilly & Co., 611 F.3d 1381, 1386-88 (Fed. Cir. 2010), AbbVie Inc. v. Kennedy Institute of Rheumatology Trust, 764 F.3d 1366 (Fed. Cir. 2014), and MPEP §804 to construe the issued claims and identify the utilities of embodiments falling within the scope of those claims.
Regarding the secondary references relied upon in an obviousness-type double-patenting analysis, Sinai was published 15 February 2018, and Nijhawan published 10 October 2019, both before the 27 November 2023 effective filing date of the instant claimed invention, and thus, independently qualify as prior art. The independently qualifying prior-art references provide the additional cannabis, cannabinoid, terpene, vitamin, and dosage teachings used in the obviousness analysis.
The reference patent and Sinai teach the limitations of instant claims 1 and 13 as described above, from which instant claims 9, 10 and 18 depend, however does not explicitly teach all of the specific limitations of instant claims 9, 10 and 18.
Instant claim 9 requires additional vitamin limitations. The reference patent claims the underlying metal/peptide topical composition, and its specification expressly describes embodiments of the claimed composition formulated as night cream containing additional mineral salts and vitamins (col. 13, ll. 19-23). That disclosure pertains directly to an embodiment falling within the open-ended issued composition claim and is considered for claim construction rather than as separate prior art. Sinai supplies the known cannabis-topical modification (as discussed above).
Nijhawan expressly teaches pharmaceutical cannabis compositions containing vitamin B9 from about 25-2000 mcg/dose and Vitamin B12 from about 250-2000 mcg/dose, and vitamin B9 from about 250–400 mcg/dose and Vitamin B12 from about 450-550 mcg/dose (claims 7 and 8). Those ranges correspond directly to the ranges recited in instant claim 9. Thus, it would have been prima facie obvious to select these known B9/B12 amounts when adding vitamins to the known cannabis-containing version of the patented topical composition, particularly because the reference patent itself contemplates vitamins as additional components of the claimed topical formulation and Nijhawan expressly teaches the claimed vitamin quantities in cannabis-containing pharmaceutical compositions. The additional vitamin limitations therefore do not render instant claim 9 patentably distinct.
Regarding instant claim 10, the reference patent provides the underlying claimed topical composition. Sinai renders addition of cannabis extract to that composition obvious. Nijhawan expressly teaches cannabis compositions containing approximately 1-30 mg cannabinoid per dose, preferably approximately 2.5-10 mg cannabinoid per dose (claims 11 and 12). These are expressly recited alternatives in instant claim 10. Selection of one of these known cannabinoid dosing ranges for the known topical cannabis component would have been no more than use of a known therapeutically suitable cannabis amount in the predictably modified patented composition. Thusm, instant claim 10 therefore is not patentably distinct.
Regarding instant claim 18, for the reasons provided with respect to instant claim 13, the disclosed topical use of the composition claimed in the reference patent modified by the known cannabis addition taught by Sinai, renders the basic method of instant claim 13 not patentably distinct. Nijhawan expressly teaches approximately 1-30 mg cannabinoid per dose and approximately 2.5-10 mg cannabinoid per dose (claims 11 and 12). Both are expressly encompassed alternatives of instant claim 18. Thus, it would have been prima facie obvious to employ one of these known cannabinoid dose amounts when performing the otherwise obvious topical method. Instant claim 18 is therefore not patentably distinct.
A timely terminal disclaimer may potentially overcome a nonstatutory double-patenting rejection where the requirements of 37 CFR 1.321(c), including the applicable common-ownership requirement, are satisfied. The filing of a terminal disclaimer alone does not constitute a complete reply, a request for reconsideration is also required (see MPEP § 804 and § 1490).
Conclusion
No claims are allowed.
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/RL Scotland/
Examiner, Art Unit 1615
/Robert A Wax/Supervisory Patent Examiner, Art Unit 1615
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