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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on June 18, 2025, has been entered.
Status of the Claims
Claims 1-3 and 6-14 are pending. Claim 1 was amended in the response filed June 18, 2025.
Claims 6-10 remain withdrawn from further prosecution for the reasons made of record.
Terminal Disclaimer
The terminal disclaimer filed on September 18, 2023, disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of Application No. 18/116,849 has been reviewed and is accepted. The terminal disclaimer has been recorded.
Claim Interpretation
Legal standard: Broadest Reasonable Interpretation (BRI):
“treatment of chronic pain using transdermal hormone supplementation”: Treating chronic pain using transdermal hormone supplementation is an intended use recitation. The claimed composition must be capable of treating chronic pain using transdermal hormone supplementation. However, the composition is not limited to this or any particular use. The composition as claimed can be used in other applications so long as the composition is also capable of treating chronic pain using transdermal hormone supplementation. Prior art that reads on the claims does not have to recognize treating chronic pain so long as the prior art composition is capable of doing so.
“an amount of L-DOPA sufficient to raise HGH levels in a human”: Sufficient to raise HGH levels in a human is an intended use recitation. The claimed composition must be capable of raising HGH levels in a human. However, the composition is not limited to this or any particular use. The composition as claimed can be used in other applications so long as the composition is also capable of raising HGH levels in a human. Prior art that reads on the claims does not have to recognize raising HGH levels in a human so long as the prior art composition is capable of doing so.
“aqueous gel”: The specification does not define, nor exemplify, “aqueous gel” or “gel”, accordingly under BRI, the “plain meaning” of this term at the filing date, consistent with the specification controls.
The term "aqueous gel" broadly refers to an aqueous dispersion, in semi-solid form comprising water and a hydrophilic polymeric substance dispersed therein. See, e.g., Bar-Shalom et al (WO 2015/177288A1) at p. 6. See also generally, Saroha et al. (Int’l J. Pharm., Chem. And Biol. Sciences 3 :495-503 (2013)).
“the L-DOPA has a molecular weight of approximately 197 g/mo(l)”: “L-DOPA” is limited to the single structure on page 4, line 26 of the specification
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, the molecular weight of which is 197.188 g/mol.
“wherein eucalyptol and menthol are included in concentrations effective to both alleviate localized pain and enhance passive transdermal delivery of the hormone supplement component without the use of microneedles, iontophoresis or electroporation,”: Alleviate localized pain and enhance passive transdermal delivery are intended use recitations. The claimed composition must be capable of alleviating localized pain and enhancing passive transdermal delivery. However, the composition is not limited to this or any particular use. The composition as claimed can be used in other applications so long as the composition is also capable of alleviating localized pain and enhancing passive transdermal delivery. Prior art that reads on the claims does not have to recognize alleviating localized pain and enhancing passive transdermal delivery so long as the prior art composition is capable of doing so.
“are configured to enable coordinated systemic and local treatment of chronic pain through co-delivery of L-DOPA and the simultaneous localized delivery of analgesic agents”: Enabling coordinated systemic and local treatment of chronic pain is an intended use recitations. The claimed composition must be capable of enabling coordinated systemic and local treatment of chronic pain. However, the composition is not limited to this or any particular use. The composition as claimed can be used in other applications so long as the composition is also capable of enabling coordinated systemic and local treatment of chronic pain. Prior art that reads on the claims does not have to recognize enabling coordinated systemic and local treatment of chronic pain so long as the prior art composition is capable of doing so.
Claim Objections - withdrawn
The objection to claim 1 is withdrawn in view of the amendment filed June 18, 2025.
Claim Rejections - 35 USC § 112 - withdrawn
The rejection of claims 1-3 and 11-14 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, is withdrawn in view of the amendment filed June 18, 2025.
The rejection of claims 1-3 and 11-14 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, is withdrawn in view of the amendment filed June 18, 2025.
However, new grounds of rejection are made.
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 1-3 and 11-14 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. This is a new matter rejection.
The MPEP states that "[w]hile there is no in haec verba requirement, newly added claim limitations must be supported in the specification through express, implicit, or inherent disclosure" (see, e.g., MPEP § 2163(I)(B)).
In the response filed June 28, 2025, claim 1 was amended to include the limitation “wherein eucalyptol and menthol are included in concentrations effective to both alleviate localized pain and enhance passive transdermal delivery of the hormone supplement component without the use of microneedles, iontophoresis or electroporation”. Accordingly, the claim has been amended to limit the amount of eucalyptol and menthol to concentrations capable of this function, whereas the claims were originally directed to therapeutically effective amounts of eucalyptol and menthol.
The amended claim language does not literally appear in the originally-filed disclosure. Zero examples of the instantly claimed invention literally appear in the originally-filed disclosure. Specifically, although amounts of eucalyptol and menthol sufficient for penetration enhancement are disclosed, no mention of without the use of microneedles, iontophoresis or electroporation is found in the original disclosure. In fact the word “electroporation” never appears. Accordingly, the amended claim scope is not supported by express disclosure in the originally-filed disclosure.
The specification describes at paragraph [0171] amounts of eucalyptus and menthol capable of penetration enhancement, but no disclosure is present which reasonably suggests that this necessarily the same amount that would permit penetration “without the use of microneedles, iontophoresis or electroporation” as required by the amended claims.
The specification describes at paragraph [0015] describes the negative aspects of invasive routes. In addition, the specification describes at paragraph [0015] the use penetration (or permeation) enhancers to help large biomolecules across the skin barrier without technological assistance or administering a smaller precursor molecule that more easily crosses the skin barrier and then stimulates synthesis of the larger target biomolecules in vivo. Although this disclosure is related to passive transport, which excludes microneedles or device-based methods, it does not explicitly connect eucalyptus and menthol to the exclusion of microneedles, iontophoresis or electroporation. In fact, “electroporation” is never discussed in the specification in any context.
Therefore, the specification does not provide inherent or implicit support for the newly amended claim scope. Dependent claims 2-3 and 11-14 fail to remedy this issue and are likewise rejected.
Claims 1-3 and 11-14 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1 recites the limitation “wherein eucalyptol and menthol are included in concentrations effective to both alleviate localized pain and enhance passive transdermal delivery of the hormone supplement component without the use of microneedles, iontophoresis or electroporation”.
The specification fails to reduce to practice a concentration of eucalyptol and menthol sufficient to both alleviate localized pain and enhance passive transdermal delivery of the hormone supplement component without the use of microneedles, iontophoresis or electroporation. The specification fails to provide a single working example of the claimed invention that would demonstrate that Applicant was in possession of the invention at the time the application was filed.
In addition, the specification fails to provide the guidance pertaining to the claimed concentration. Specifically, although amounts of eucalyptol and menthol sufficient for penetration enhancement are disclosed, no mention of without the use of microneedles, iontophoresis or electroporation is found in the original disclosure. In fact the word “electroporation” never appears. The specification describes at paragraph [0171] amounts of eucalyptus and menthol capable of penetration enhancement, but no disclosure is present which reasonably suggests that this necessarily the same amount that would permit penetration “without the use of microneedles, iontophoresis or electroporation” as required by the amended claims.
The specification describes at paragraph [0015] describes the negative aspects of invasive routes. In addition, the specification describes at paragraph [0015] the use penetration (or permeation) enhancers to help large biomolecules across the skin barrier without technological assistance or administering a smaller precursor molecule that more easily crosses the skin barrier and then stimulates synthesis of the larger target biomolecules in vivo. Although this disclosure is related to passive transport, which excludes microneedles or device-based methods, it does not explicitly connect eucalyptus and menthol to the exclusion of microneedles, iontophoresis or electroporation. In fact, “electroporation” is never discussed in the specification in any context.
Therefore, the specification fails to demonstrate that Applicant was in possession of the invention at the time the application was filed. Dependent claims 2-3 and 11-14 fail to remedy this issue and are likewise rejected.
Claims 1-3 and 11-14 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for formulating eucalyptol and menthol in amounts for alleviating pain, does not reasonably provide enablement for formulating eucalyptol and menthol in amounts to enhance passive transdermal delivery of the hormone supplement component without the use of microneedles, iontophoresis or electroporation. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make the invention commensurate in scope with these claims.
MPEP § 2164.01 states: “In Amgen Inc. et al. v. Sanofi et al., 598 U.S. 594, 2023 USPQ2d 602 (2023), the Supreme Court, held that claims drawn to a genus of monoclonal antibodies, which were functionally claimed by their ability to bind to a specific protein, PCSK9, were invalid due to lack of enablement. The claims at issue were functional, in that they defined the genus by its function (the ability to bind to specific residues of PCSK9) as opposed to reciting a specific structure (the amino acid sequence of the antibodies in the genus). The Supreme Court concluded that the patents at issue failed to adequately enable the full scope of the genus of antibodies that performed the function of binding to specific amino acid residues on PCSK9 and blocking the binding of PCSK9 to a particular cholesterol receptor, LDLR.“
In the instant case, the amount of eucalyptol and menthol in the claimed composition are functionally claimed by their ability to both alleviate localized pain and enhance passive transdermal delivery of the hormone supplement component without the use of microneedles, iontophoresis or electroporation as opposed to reciting numerical concentrations.
The specification fails to reduce to practice a concentration of eucalyptol and menthol sufficient to both alleviate localized pain and enhance passive transdermal delivery of the hormone supplement component without the use of microneedles, iontophoresis or electroporation.
In addition, the specification fails to provide the guidance pertaining to the claimed concentration. Specifically, although amounts of eucalyptol and menthol sufficient for penetration enhancement are disclosed, no mention of without the use of microneedles, iontophoresis or electroporation is found in the original disclosure. In fact the word “electroporation” never appears. The specification describes at paragraph [0171] amounts of eucalyptus and menthol capable of penetration enhancement, but no disclosure is present which reasonably suggests that this necessarily the same amount that would permit penetration “without the use of microneedles, iontophoresis or electroporation” as required by the amended claims.
The specification describes at paragraph [0015] describes the negative aspects of invasive routes. In addition, the specification describes at paragraph [0015] the use penetration (or permeation) enhancers to help large biomolecules across the skin barrier without technological assistance or administering a smaller precursor molecule that more easily crosses the skin barrier and then stimulates synthesis of the larger target biomolecules in vivo. Although this disclosure is related to passive transport, which excludes microneedles or device-based methods, it does not explicitly connect eucalyptus and menthol to the exclusion of microneedles, iontophoresis or electroporation. In fact, “electroporation” is never discussed in the specification in any context.
Therefore, one of ordinary skill in the art seeking to practice the claimed invention would be subjected to an undue burden of experimentation to discover which concentrations of menthol and eucalyptol can achieve the claimed effect. Dependent claims 2-3 and 11-14 fail to remedy this issue and are likewise rejected.
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 the applicant regards as his invention.
Claims 11-14 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 (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
In claim 11, the indefinite language is: wherein the L-DOPA is provided via velvet bean extract comprising between 0.1% and 0.9% by weight of the aqueous gel.
BRI of this limitation includes multiple, plausible constructions: 1) velvet bean extract containing L-DOPA is added to the aqueous gel and the concentration of velvet bean extract is between 0.1% and 0.9% by weight of the aqueous gel, and 2) velvet bean extract containing L-DOPA is added to the aqueous gel and the concentration of L-DOPA is between 0.1% and 0.9% by weight of the aqueous gel.
The language is indefinite because it is not clear which construction is covered (e.g., because there is more than one reasonable interpretation of what construction is included in the claim). See MPEP § 2173.04. The actual concentration of L-DOPA and velvet bean extract in the gel are unclear.
Claim 12 recites the limitation "the eucalyptus oil" in claim 1. There is insufficient antecedent basis for this limitation in the claim.
In claim 13, the indefinite language is: wherein the menthol is provided via peppermint oil comprising between 2.5% and 3.5% by weight of the aqueous gel.
BRI of this limitation includes multiple, plausible constructions: 1) peppermint oil containing menthol is added to the aqueous gel and the concentration of peppermint oil is between 2.5% and 3.5% by weight of the aqueous gel, and 2) peppermint oil containing menthol is added to the aqueous gel and the concentration of menthol is between 2.5% and 3.5% by weight of the aqueous gel.
The language is indefinite because it is not clear which construction is covered (e.g., because there is more than one reasonable interpretation of what construction is included in the claim). See MPEP § 2173.04. The actual concentration of menthol and peppermint oil in the gel are unclear.
In claim 14, the indefinite language is: wherein the CBD comprises approximately 1% by weight of the aqueous gel. The language is indefinite because in the previous claim 1, the aqueous gel comprises CBD whereas in the dependent claim the CBD comprises the aqueous gel. The relationship of these two elements is unclear, including the concentration of CBD.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-3 and 11-14 are rejected under 35 U.S.C. 101 because the claimed invention is directed to natural phenomenon without significantly more. Claims 1-3 and 11-14 recite a naturally occurring product, which is not markedly different from its naturally occurring counterpart. See MPEP §§ 2106 et seq. This rejection has been modified to address the amendment to the claims filed January 21, 2025.
Claims 1-3 and 11-14 are directed to a composition for the treatment of chronic pain using transdermal hormone supplementation delivered as an aqueous gel comprising a hormone supplement component comprising an amount of L-DOPA sufficient to raise HGH levels in a human, wherein the L-DOPA has a molecular weight of approximately 197 g/mol, and an analgesic component comprising a therapeutically effective mixture of β-caryophyllene, eucalyptol, CBD, and menthol. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception for the following reasons. This judicial exception is not integrated into a practical application because the claimed composition comprises naturally occurring components. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because for the following reasons.
Step 1: Is the claim to a process, machine, manufacture or composition of matter? The instant claims are directed to a statutory patent-eligible subject matter category, a composition of matter.
Step 2a Prong 1: Is the claim directed to a law of nature, a natural phenomenon (Product of nature), or an abstract idea? The claims are directed to a nature-based product: an aqueous gel comprising a combination of a hormone supplement comprising L-DOPA, and an analgesic component comprising β-caryophyllene, eucalyptol, CBD, and menthol. The closest naturally-occurring counterpart is the individual nature-based components of the combination. This approach is supported by MPEP § 2106.04(c)(II)(A): “Because there is no counterpart mixture in nature, the closest counterparts to the claimed mixture are the individual components of the mixture, i.e., each naturally occurring species by itself. See, e.g., Funk Bros., 333 U.S. at 130, 76 USPQ at 281”
As evidenced by Soares et al. (Plant signaling and behavior 9:4, pp. 1-8 (2014)- previously cited), L-DOPA is a naturally occurring plant product. Plants produce hundreds of non-protein amino acids, among which L-DOPA, a compound with strong allelopathic activity, stands out. This allelochemical is found in large quantities (1% and 4–7% in the leaves and seeds, respectively) in velvet bean [Mucuna pruriens (L.) var. utiliz], a legume of the Fabaceae family that has a nutritional quality comparable to the soybean (p. 2). L-DOPA has also been found at high levels in fava bean (Vicia faba L.), one of the oldest crops in Europe, traditionally used for animal feed and human food, and as broad beans for direct human consumption. Id. See also the as-filed application at para. [0173]. The chemical structure of the L-DOPA is the same in nature and in the composition. The specification describes L-DOPA as a treatment for Parkinson’s disease in paragraph [0016].
As evidenced by Delgado-Povedano et al. (Tatlanta 208: 120384, pp. 1-10 (2020)- previously cited), Cannabis sativa extracts contain cannabidiol ((CBD; pp. 2, 5, 8), β-caryophyllene (pp. 4 and 6), eucalyptol (pp. 5 and 7), and menthol (pp. 5 and 7). Examiner further notes that the as-filed application indicates that β-caryophyllene, eucalyptol, CBD, and menthol are naturally found within Cannabis. See specification at e.g., paras. [0048]-[0052], [0069]-[0070], [0129] and [0154]. The chemical structures of CBD, β -caryophyllene, eucalyptol, and menthol are the same in nature and in the composition. The functional properties of CBD, β -caryophyllene, eucalyptol, and menthol are the same in nature and in the composition: the specification asserts that CBD can be used for chronic pain (para. [0174]), that the combination of CBD and β-caryophyllene can be used for chronic pain (para. [0071]), that β-caryophyllene has antinociceptive properties, blocking sensory neuron detection of pain stimuli (para. [0072]), that menthol exhibits analgesic properties and is used topically to treat inflammatory pain (para. [0129]), and that eucalyptol relieves pain (para. [0153]).
An “aqueous gel” may also be naturally occurring. For instance, but not limited to, aloe vera pulp or gel can read on a naturally occurring aqueous gel.
There is no evidence in the claims, specification, or prior art that the aqueous gel comprising combination of L-DOPA, β-caryophyllene, eucalyptol, CBD, and menthol is markedly different from the corresponding elements in nature. Although the amended claims recite an intended use of treatment for chronic pain and coordinated systemic and local treatment of chronic pain, there is no evidence in the specification or art that the combination of L-DOPA, β-caryophyllene, eucalyptol, CBD, and menthol as a whole possesses this activity in a way that is different than the L-DOPA, β-caryophyllene, eucalyptol, CBD, and menthol on their own in nature. The specification acknowledges that all other elements of the combination possess the ability to treat pain on their own and are not transformed by being in the combination. There is no evidence for any structural or functional differences between the claimed nature-based product and the closest naturally-occurring counterpart. Therefore, the claims are directed to a natural phenomenon.
Step 2a Prong 2: Does the claim recite additional elements that integrate the judicial exception into a practical application? The claims recite the intended use “treatment of chronic pain using transdermal hormone supplementation,” “sufficient to raise HGH levels in a human,” “therapeutically effective amounts,” “effective to both alleviate localized pain and enhance passive transdermal delivery,” and “to enable coordinated systemic and local treatment of chronic pain”. Under BRI the amount of the L-DOPA, β-caryophyllene, eucalyptol, CBD, and menthol in the aqueous gel must be capable of treating chronic pain using transdermal hormone supplementation. However, the composition is not limited to these or any particular use. The composition as claimed can be used in other applications as long as the composition is also capable of the claimed intended use. As a result, the claimed judicial exception is not integrated into a practical application.
Step 2b: Does the claim recite additional elements that amount to significantly more than the judicial exception? The claims recite the intended use “treatment of chronic pain using transdermal hormone supplementation,” sufficient to raise HGH levels in a human,” and “therapeutically effective amounts,” “effective to both alleviate localized pain and enhance passive transdermal delivery,” and “to enable coordinated systemic and local treatment of chronic pain”. Under BRI the amount of the L-DOPA, β-caryophyllene, eucalyptol, CBD, and menthol in the aqueous gel must be capable of treating chronic pain using transdermal hormone supplementation. However, the composition is not limited to this or any particular use. The composition as claimed can be used in other applications as long as the composition is also capable of the claimed intended use. As a result, the claims, as a whole, do not recite any additional elements that amount to significantly more than the judicial exception.
Claim 1 is therefore patent ineligible.
Regarding claim 2, as noted in the as-filed specification at paras. [0174] and [0176], salicylic glycosides, e.g., salicin is an active ingredient of willow bark. Thus, salicylic glycosides are naturally occurring plant products. There is no evidence that the addition of the salicylic glycosides renders the composition markedly different in structure, function or any way from the naturally-occurring counterpart. This judicial exception is not integrated into a practical application because only a composition comprising naturally occurring components is claimed. Claim 2 does not recite any elements that amount to anything significantly more than the judicial exception. Although the claims recite the intended use “treatment of chronic pain using transdermal hormone supplementation” and “therapeutically effective amounts” the compositions of matter are not limited to this or any particular use. Therefore, claim 2 is ineligible.
Regarding claim 3, as noted in the as-filed specification at paras. [0150] and [0175], 2,5-dimethoxy-p-cymene is a phytochemical naturally found in the essential oils of plants within the family Asteraceae, such as Arnica montana. There is no evidence that the addition of the 2,5-dimethoxy-p-cymene renders the composition markedly different in structure, function or any way from the naturally-occurring counterpart. This judicial exception is not integrated into a practical application because only a composition comprising naturally occurring components is claimed. Claim 3 does not recite any elements that amount to anything significantly more than the judicial exception. Although the claims recite the intended use “treatment of chronic pain using transdermal hormone supplementation” and “therapeutically effective amounts” the compositions of matter are not limited to this or any particular use. Therefore, claim 3 is ineligible.
With respect to claim 11, as evidenced by Soares et al. (Plant signaling and behavior 9:4, pp. 1-8 (2014)- previously cited), L-DOPA is a naturally occurring plant product found in large quantities (1% and 4–7% in the leaves and seeds, respectively) in velvet bean [Mucuna pruriens (L.) var. utiliz], a legume of the Fabaceae family that has a nutritional quality comparable to the soybean (p. 2). The amount of L-DOPA recited in the claims does not render the claimed composition markedly different that the naturally occurring counterpart, integrate the judicial exception into a practical application, or provide significantly more than the judicial exception. Therefore, claim 11 is patent ineligible.
With respect to claims 12 and 14, the as-filed application indicates that eucalyptol oil and CBD are naturally found within Cannabis. See specification at e.g., paras. [0048]-[0052], [0069]-[0070], [0129] and [0154]. The amount of eucalyptol oil and CBD recited in the claims does not render the claimed composition markedly different that the naturally occurring counterpart, integrate the judicial exception into a practical application, or provide significantly more than the judicial exception. Therefore, claims 12 and 14 are patent ineligible.
With respect to claim 13, the as-filed application indicates that menthol is found in peppermint oil (Mentha piperaeatheroleum). See specification at e.g., paras. [0127], [0171]. The amount of peppermint oil recited in the claim does not render the claimed composition markedly different that the naturally occurring counterpart, integrate the judicial exception into a practical application, or provide significantly more than the judicial exception. Therefore, claim 13 is patent ineligible.
Response to Applicant’s Arguments
Applicant's arguments filed June 18, 2025, have been fully considered but they are not persuasive.
Applicant traverses the rejection on the grounds that the claims as amended integrate the components into a purpose-built formulation that does not preempt the use of the recited compounds in other contexts. Applicant argues that the claims are to a specific pharmaceutical configuration that solves a real-world delivery and therapeutic coordination problem. This argument is not persuasive.
Because the limitations pertaining to treatment of chronic pain, hormone supplementation, and penetration enhancement do not actually provide a treatment or prophylaxis, e.g., it is merely an intended use of the claimed invention or a field of use limitation, then it cannot integrate a judicial exception under the "treatment or prophylaxis" consideration (See MPEP § 2106.04(d)(2)).
For these reasons, the rejection is maintained.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) 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.
The previous grounds of rejection is withdrawn and a new rejection is made to address the amended claims.
Claims 1 and 11-14 are rejected under 35 U.S.C. 103 as being unpatentable over Fitzsimmons et al. (WO 2020/257538), as evidenced by Levodopa (ChemSpider ID 5824, accessed 7/26/2023 at URL chemspider.com/Chemical-Structure.5824.html- previously cited), in view of King (accessed at URL cannabisplace.com.au/learn/parkisons-and-cbd/, pp. 1-8 (2020), previously cited, hereinafter referred to as “King PD”), Delgado-Povedano et al. (Tatlanta 208: 120384, pp. 1-10 (2020), previously cited), Ligouri (U.S. 2022/0105107, previously cited), Bundrla et al, “A Review on Natural Permeation Enhancer for Transdermal Drug Delivery System and Permeation Evaluation,” Int'l J Pharm Pharma Res. Human 19: 56-72 (2020) (previously cited PTO-892 10/26/2023), Vaay, “Menthol to limonene: a cool guide to CBD gel ingredients,” accessed at URL uk.vaay.com/blogs/cbd-magazine/ cbd-gel-ingredients, pp. 1-11 (2021) (previously cited PTO-892 10/26/2023), Saroha et al., “Transdermal Gels-An Alternative Vehicle for Drug Delivery” Int'l J. Pharm., Chem. And Biol. Sciences 3 :495-503 ( 2013) (previously cited PTO-892 10/26/2023), L-DOPA, “L-DOPA for Growth Hormone’ ; Supplements in Review (2016) accessed at URL supplementsinreview.com/- growth-hormone, I-dopa ..., pp. 1-6 (previously cited PTO-892 10/26/2023), Sudo et al. (“Transdermal absorption of L-dopa from hydrogel in rats,” European Journal of Pharmaceutical Sciences, 7 (1998) 67-71), Nerenberg (US 20050143343), Quay (US 20050031549), Tsuk (US 4,933,184), Zupan (US 4,440,777), Scandiffio et al. (“Protective Effects of (E)-β-Caryophyllene (BCP) in Chronic Inflammation,” Nutrients. 2020 Oct 26;12(11):3273), Vu et al. (US 20180344663), Mosbaugh et al. (US 20080038219), Giniger et al. (US 20070122362), and Theobold et al. (US 20070026054 A1).
Determining the scope and contents of the prior art.
Fitzsimmons et al. teach transdermal delivery formulations comprising a cannabidiol, with or without one or more additional active agents through the dermis of a subject, wherein the formulation comprises a) a transdermal delivery formulation in an amount less than about 60 %w/w, comprising i. one or more phosphatides and ii. one or more fatty acids; b) water in an amount less than about 50% w/w, a Cannabidiol with or within one or more additional active agents (abstract, claim 1, 3, 7-9, 52). Additional active agents in the transdermal formulations include levodopa (para. [0095], claim 60). Transdermal formulations comprising levodopa can be used to treat Parkinson’s disease (para. [0087], [0095], claims 52 and 60). Fitzsimmons et al. teach that an effective amount of CBD and additional active agents is sufficient to achieve the alleviation or amelioration of the signs, symptoms, or causes of a disease (para. [0017], [0052]-[0055]). Fitzsimmons exemplify compositions containing 2.5 % wt CBD (Tables 6-7). The compositions can be formulated as a gel containing water (paras. [0070], [0074], [0115], [0177]). Fitzsimmons et al. teach that the transdermal delivery formulations can comprise menthol as a skin penetration enhancer (e.g., paras. [0082], [0176], [0250], claim 41). Menthol can be also be incorporated for cooling pain relief in an amount from about 0.1% w/w to about 1.0% w/w (para. [00102], [00176]) or 0.05 to 5% w/w (claim 41).
The teaching of Fitzsimmons et al. maps to claim 1 as follows:
Claim 1
Primary Reference
A composition for treatment of chronic pain
Fitzsimmons teaches that the transdermal formulations containing CBD and additional active agents can be used for the treatment of multiple diseases including pain, severe pain, chronic neuropathic pain, and Parkinson’s disease (para. [0087], claim 53). In Example 4, Fitzsimmons reduce to practice the treatment of a patient suffering from severe pain (para. [00296]): “A male patient, age 43 presents with severe pain in his back that requires the patient to take oxycontin on a regular basis. The patient’s doctor determines that the patient is at risk of becoming addicted to oxycontin and prescribes a transdermal delivery formulation containing CBD at a concentration of 75mg/kg applied daily to the back of the patient. Within a few days following application of the transdermal delivery formulation containing CBD, the patient begins to suffer from a reduction of the pain in his back. Over the next few weeks, the amount of pain the patient suffers was reduced by over 50%. The patient continues to apply the transdermal formulation containing CBD to his back with the result that the patient is able to maintain his pain with Tylenol and/or ibuprofen.”
using transdermal
Fitzsimmons is entirely directed to transdermal formulations of CBD and additional active agents (entire document, especially claims 1-61 and Examples 3-4).
Fitzsimmons teach (para. [0008]): “disclosed herein is a transdermal delivery formulation of an active agent through the dermis of a patient, including the skin, nail or hair follicle, wherein the formulation comprises a) a transdermal delivery formulation in an amount less than about 60% w/w, comprising i. one or more phosphatides and ii. one or more fatty acids; b) water in an amount less than about 50% w/w and Cannabidiol.”
In Example 3, Fitzsimmons reduced to practice the plasma pharmacokinetic (PK) profile of test article cannabidiol (CBD) following the administration of a single topical dose to CD-1 mice. Animals in each group received topical administration of either 2.5% or 5% CBD using a 1 ml syringe to draw up exactly 100 µl. Compound was applied in the shaved area only.
In Example 4, Fitzsimmons reduced to practice transdermal administration of CBD to treat chronic severe pain: “ Within a few days following application of the transdermal delivery formulation containing CBD, the patient begins to suffer from a reduction of the pain in his back.”
hormone supplementation
delivered as an aqueous gel
Fitzsimmons teaches that the transdermal formulation is aqueous (i.e. water-containing formulations) (para. [0035]): “In an embodiment, a transdermal delivery formulation contains water in a concentration of at least 0.1%, at least 0.2%, at least 0.3%, at least 0.4%, at least 0.5%, at least 1%, at least 2%, at least 3%, at least 4%, at least 5%, at least 10%, at least 15%, at least 20%, at least 25%, at least 30%, at least 35%, at least 40%, at least 45%, at least 50%, at least 55%, at least 60%, at least 65%, at least 70% or more w/w of the transdermal delivery formulation.”
The transdermal delivery formulation shown in Table 3 contains 59.65% deionized water.
Fitzsimmons also teaches that the transdermal formulation is a gel, including an aqueous gel (para. [0066], [0069], [0074], [0075]). See especially para [0069]: “the performance of a transdermal delivery formulation is further improved by including a nonionic detergent and polar gelling agent or including a powdered surfactant. In both aqueous and anhydrous forms of the composition, detergents, typically nonionic detergents are added. In general, the nonionic detergent should be present in an amount between about 1% w/w to 30% w/w of a transdermal delivery formulation. Typically, in the compositions wherein a transdermal delivery formulation is topped off with a polar or aqueous solution containing detergent, the amount of detergent is relatively low - e.g., 2-25% w/w, or 5-15% w/w or 7-12% w/w of a transdermal delivery formulation. However, in compositions that are essentially anhydrous and are topped-off by powdered detergent, relatively higher percentages are usually used - e.g., 20-60% w/w.”
See especially para [0074]: “ In the presence of a polar gelling agent, such as water, glycerol, ethylene glycol or formamide, a micellular structure is also often achieved. Typically, the polar agent is in molar excess of the nonionic detergent. The inclusion of the nonionic detergent/polar gelling agent combination results in a more viscous and cream-like or gel-like formulation which is suitable for application directly to the skin. This is typical of the aqueous forms of the composition.”
comprising a hormone supplement component comprising an amount of L-DOPA sufficient to raise HGH levels in a human
wherein the L-DOPA comprises C9H11NO4 with a molecular weight of approximately 197 g/mol
Fitzsimmons teaches that the transdermal formulations containing CBD and an additional active agent may contain L-DOPA1 as the additional agent (para. [0095]):
“In an embodiment, the transdermal delivery formulation comprises cannabidiol and an additional active agent for the treatment of Parkinson’s disease, including one or more of the following, Benztropine mesylate, Entacapone, Dopar, Larodopa, Levodopa and carbidopa, Pramipexole, Rasagiline, Ropinirole HCl, Rotigotine, Safinamide, Tasmar or Trihexphenidyl.”
Fitzsimmons reduces to practice the treatment of Parkinson’s disease in para. [00298]: “A male patient 56 years of age presents with Parkinson’s disease. The patient has begun to lose motor function and mental cognition. The doctor prescribes a transdermal formulation with CBD, starting at 20 mg/kg and increasing every two weeks until reaching 75mg/kg. Within a short period of time following administration of the transdermal formulation with CBD, the severity of the symptoms of Parkinson’s disease begin to ameliorate and the onset of new symptoms is slowed.”
comprising an analgesic component comprising a therapeutically effective amount of
Fitzsimmons teaches in para. [0017] that the agents of the transdermal formulation are present in “an effective amount” which means: “the amount of the defined component sufficient to achieve the desired chemical composition or the desired biological and/or therapeutic result… the desired result is the alleviation or amelioration of the signs, symptoms, or causes of a disease, or any other desired alteration of a biological system. When the desired result is a therapeutic response, the effective amount will, without limitation, vary depending upon the specific disease or symptom to be treated or alleviated, the age, gender and weight of the subject to be treated, the dosing regimen of the formulation, the severity of the disease condition, the manner of administration and the like, all of which can be determined readily by one of skill in the art.”
b-caryophyllene
eucalyptol
cannabidiol and
Fitzsimmons teach generally in para. [0052] that the effective amount of CBD in a transdermal formulation is: “10 mg/kg, 15 mg/kg, 20 mg/kg, 25 mg/kg, 30 mg/kg, 35 mg/kg, 40 mg/kg, 50 mg/kg, 55 mg/kg, 60 mg/kg, 65 mg/kg, 70 mg/kg, 75 mg/kg, 80 mg/kg, 85 mg/kg, 90 mg/kg, 95 mg/kg, 100 mg/kg, 105 mg/kg, 110 mg/kg, 115 mg/kg, 120 mg/kg, 125 mg/kg, 130 mg/kg, 135 mg/kg, 140 mg/kg, 145 mg/kg, 150 mg/kg, 155 mg/kg, 160 mg/kg, 165 mg/kg, 170 mg/kg, 175 mg/kg, 180 mg/kg, 190 mg/kg, 195 mg/kg, 200 mg/kg, 205 mg/kg, 210 mg/kg, 215 mg/kg, 220 mg/kg, 225 mg/kg, 230 mg/kg, 235 mg/kg, 240 mg/kg, 245 mg/kg, 250 mg/kg, 275 mg/kg, 300 mg/kg, 325 mg/kg, 350 mg/kg, 375 mg/kg, 400 mg/kg, 425 mg/kg, 450 mg/kg, 475 mg/kg or greater than 500 mg/kg.”
In Example 4, Fitzsimmons reduce to practice the treatment of a patient suffering from severe pain (para. [00296]). Therefore, the amount of CBD in the transdermal formulation taught by Fitzsimmons is an effective amount to treat chronic pain and to achieve an analgesic effect: “A male patient, age 43 presents with severe pain in his back that requires the patient to take oxycontin on a regular basis. The patient’s doctor determines that the patient is at risk of becoming addicted to oxycontin and prescribes a transdermal delivery formulation containing CBD at a concentration of 75mg/kg applied daily to the back of the patient. Within a few days following application of the transdermal delivery formulation containing CBD, the patient begins to suffer from a reduction of the pain in his back. Over the next few weeks, the amount of pain the patient suffers was reduced by over 50%. The patient continues to apply the transdermal formulation containing CBD to his back with the result that the patient is able to maintain his pain with Tylenol and/or ibuprofen.”
menthol
Fitzsimmons teaches that the transdermal formulations containing CBD and an additional active agent may contain menthol as the additional agent (para. [0102]), [0176], [0250], claim 41). See especially para. [0176]: “Menthol, phenol, and terpenoids, e.g., camphor, can be incorporated for cooling pain relief. For example, menthol may be included in an amount ranging from about 0.1% w/w to about 1.0% w/w.” See especially claim 41 and para. [0250]): “the formulation comprises menthol in an amount between about 0.05-5 %w/w of the formulation.” Therefore, the amount of menthol in the transdermal formulation taught by Fitzsimmons is an effective amount to treat chronic pain and to achieve an analgesic effect.
wherein eucalyptol and menthol are included in concentrations effective to both alleviate localized pain and enhance passive transdermal delivery of the hormone supplement component without the use of microneedles, iontophoresis, or electroporation
Fitzsimmons teaches that the transdermal formulations include permeation enhancers, such as menthol, and that the transdermal formulations can be administered passively.
Regarding permeation enhancement, Fitzsimmons teaches in para. [0024]: “For transdermal topical administration in particular for agents other than buffer, a suitable formulation typically involves a penetrant that enhances penetration of the skin and is, in some embodiments, composed of chemical permeation enhancers (CPEs).”
In addition, Fitzsimmons teaches in para. [0063]: “A transdermal delivery formulation comprises mixtures wherein the components interact synergistically and induce skin permeation enhancements better than that induced by the individual components. Synergies between chemicals can be exploited to design potent permeation enhancers that overcome the efficacy limitations of single enhancers. Several embodiments disclosed herein utilize one or more distinct permeation enhancers.”
In addition, Fitzsimmons teaches in para. [0064: “For topical administration, and in particular transdermal administration, a transdermal delivery formulation will comprise penetrants including either or both chemical penetrants (CPEs) and peptide-based cellular penetrating agents (CPPs) that encourage transmission across the dermis and/or across membranes including cell membranes, as would be the case in particular for administration by suppository or intranasal administration, but for transdermal administration as well.”
Regarding menthol functioning as an analgesic and permeation enhancer, Fitzsimmons teaches in para.
[0082] that menthol has a documented “capability for effecting skin penetration” in addition to its effect of cooling pain relief.
Regarding passive administration (i.e. without the use of microneedles, iontophoresis, or electroporation), Fitzsimmons teaches in para. [0167]: “a transdermal delivery formulation itself is simply placed on the skin and spread across the surface and/or massaged to aid in penetration. The amount of transdermal delivery formulation used is typically sufficient to cover a desired surface area. In some embodiments, a protective cover is placed over the formulation once it is applied and left in place for a suitable amount of time, i.e., 5 minutes, 10 minutes, 20 minutes or more; in some embodiments an hour or two. The protective cover can simply be a bandage including a bandage supplied with a cover that is impermeable to moisture. This essentially locks in the contact of a transdermal delivery formulation to the skin and prevents distortion of a transdermal delivery formulation by evaporation in some cases. The composition may be applied to the skin using standard procedures for application such as a brush, a syringe, a gauze pad, a dropper, or any convenient applicator.”
wherein the components of the aqueous gel act synergistically are configured to enable coordinated systemic and local treatment of chronic pain through co-delivery of L-DOPA and the simultaneous localized delivery of analgesic agents
Fitzsimmons teaches in para. [0057]: “A transdermal delivery formulation comprise mixtures wherein the components interact synergistically and induce skin permeation enhancements better than that induced by the individual components. Synergies betwe