DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA . Claims 1-9 and 11-24 are pending; claims 1-3 and 7 are examined; claims 4-6, 8-9, and 11-24 are withdrawn as consistent with Applicant’s election without traverse on 4 August 2025.
Applicant’s arguments, filed 6 August 2026, have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
In response to pre-appeal brief review decision mailed on 2 September 2026, the prosecution is reopened, and this action is made NON-FINAL.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation is: “wherein the cross-linked sodium hyaluronate polymer is configured to facilitate transmembrane uptake of the supplement formulation via endocytosis” in claim 1.
Because this claim limitation is being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it is being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
To determine whether a word, term, or phrase coupled with a function denotes structure, Examiners may check whether: (1) the Specification provides a description sufficient to inform one of ordinary skill in the art that the term denotes structure; (2) general and subject matter specific dictionaries provide evidence that the term has achieved recognition as a noun denoting structure; and/or (3) the prior art provides evidence that the term is an art-recognized structure to perform the claimed function. Ex parte Rodriguez, 92 USPQ2d 1395, 1404 (Bd. Pat. App. & Int. 2009) (precedential).
Suggested Language
As previously stated, if Applicant does not intend to have this limitation interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, Applicant may: (1) amend the claim limitation to avoid it being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
A straightforward way to do that here would be to amend the claim to recite an intended use, namely: “wherein the cross-linked sodium hyaluronate polymer is for facilitating transmembrane uptake of the supplement formulation via endocytosis”.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-3 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Salamone et al. (US 2021/0121575 A1, 04/29/2021, hereinafter Salamone) in view of Leverett (US 2022/0370529 A1, 11/24/2022) and Leshchiner et al. (US 2010/0135935 A1, 06/03/2010, hereinafter Leshchiner).
Salamone discloses aqueous ([0025], [0043]) gel compositions for topical application ([0055]) comprising 0.001-25 wt. % each of one or more biologically active agents ([0073]-[0074]) such as cannabidiol ([0089]) and lutein ([0117]); and water-soluble polymers such as aloe vera and hyaluronic acid ([0048]), which aids the retention of the compositions on a biological surface and enhance the compositions interaction with a surface ([0047]).
Salamone differs from the instant claims insofar as not explicitly disclosing a plurality of cannabinoid compounds, or wherein the hyaluronic acid polymer includes a cross-linked polymer.
Leverett discloses a cannabis composition comprising a cannabis extract comprising a cannabis phytocompound, and a carrier, the composition adapted for topical administration to a subject (abs). The cannabis phytocompounds/phytocannabinoids include cannabidiol (CBD) and cannabichromene (CBC) ([0034]). The composition may comprise additive component including stabilizers ([0213]) such as lutein ([0273]). Topical formulations may further comprise a moisturizer such as sodium hyaluronate, as well as derivatives and modifications thereof ([0269]). Sodium hyaluronate is also known to penetrate the skin ([0279]) and/or act as a water phase stabilizing agent ([0296]).
Leshchiner discloses compositions for use in topical cosmetic and dermatological formulations providing prolonged delivery of incorporated substances to the surface of the skin (abs). The compositions comprise a polysaccharide matrix ([0024]) that includes cross-linked polymer of hyaluronic acid, a salt of the polymer or a derivative of the polymer ([0026]). Exemplary hyaluronic acid includes a sodium hyaluronate cross-polymer ([0043]). The crosslinked hyaluronic acid is used as a hydrated molecular cage into which one may incorporate, entrap and deliver organic and inorganic substances to the surface of the skin ([0028-0029]).
It would have been obvious to one of ordinary skill in the art to have selected CBD and CBC as the biologically active agents in the composition of Salamone since each is a known and effective compound suitable for topical formulations as taught by Leverett. "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." See MPEP 2144.06(I).
It would have been obvious to one of ordinary skill in the art to have included a sodium hyaluronate cross-polymer in the compositions of Salamone, since it is a known and effective form of hyaluronic acid polymer capable of enhancing composition interaction with a surface such as skin as taught by Leshchiner. Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use. See MPEP § 2144.07. Moreover, in any case, it would have been obvious to one of ordinary skill in the art to have selected hyaluronic acid and sodium hyaluronate cross-polymer as the hyaluronic acid polymer of Salamone, since "[i]t is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art.” See MPEP 2144.06(I).
Regarding claim 1 reciting wherein the cross-linked sodium hyaluronate polymer is configured to facilitate transmembrane uptake of the supplement formulation via endocytosis, as noted by para. [0111] of the instant Specification:
“In gel form, sodium hyaluronate forms a cross-linked polymer that can be used to envelop and deliver other compounds for absorption, enabling topically-applied sodium hyaluronate to help facilitate the absorption… without the need for invasive delivery methods. This functions through the process of endocytosis… when sodium hyaluronate is applied topically to the skin or mucous membranes, it can interact with the cells in these tissues, stimulating endocytosis and allowing for improved absorption and greater bioavailability”.
As such, it appears the process of cross-linking and endocytosis stimulation are properties innate to the sodium hyaluronate polymer. Where the components of the composition are taught by the prior art, as long as the component is present in the composition made obvious (i.e. aqueous gel comprising sodium hyaluronate polymer), there is a reasonable expectation that the functional recitations regarding such a composition are also met, given that the function of compositions is a product of the compositions’ structure. Accordingly, one of ordinary skill in the art would reasonably expect the sodium hyaluronate cross-polymer to facilitate transmembrane uptake via endocytosis like the claimed invention.
Regarding claim 3, as discussed above, Salamone discloses wherein water-soluble polymers include aloe vera. Therefore, the gel composition of Salamone, comprising aloe vera, appears to reasonably meet the limitation of an aloe vera gel substrate as instantly claimed.
Regarding claim 7 reciting an amount of the plurality of carotenoid compounds, it would have been obvious to one of ordinary skill in the art to have selected an amount of lutein from the disclosed range of 0.001-25% by weight, which appears to overlap the instantly claimed amounts in mg. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP § 2144.05(I). Moreover, in any case, the selection of appropriate weight percentages would appear to require no more than routine testing on the part of the skilled artisan, and so alternatively it would have been obvious to determine workable ranges to arrive at the claimed amounts in mg. "[W]here 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." See MPEP § 2144.05(II)(A).
Response to Arguments
In response to arguments presented in the pre-appeal request, Applicant mainly asserts that Salamone fails to disclose a “plurality” of cannabinoid compounds.
The Examiner does not find Applicant’s assertion to be persuasive. Leverett teaches a plurality of cannabinoid compounds.
Citation of Pertinent Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Warrington et al. (US 2021/0361591 A1, 11/25/2021) discloses compositions comprising a combination of cannabidiol, 0.1-100mg of an antioxidant including lutein, and moisturizing agents including hyaluronic acid.
Naheed (US 2017/0020942 A1, 01/26/2017) discloses compositions placed dermally on the skin (e.g. in a form of hydrogel) comprising cannabidiol infused in hyaluronic acid and further comprising a botanical drug substance including lutein.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LUCY TIEN whose telephone number is (571)272-8267. The examiner can normally be reached Monday - Thursday 8:30 AM - 6:30 PM EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, SAHANA KAUP can be reached at (571) 272-6897. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LUCY M TIEN/Examiner, Art Unit 1612
/SAHANA S KAUP/Supervisory Primary Examiner, Art Unit 1612
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