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 .
In view of the amendment, previous 112(d) rejection on claims 34 and 36 is hereby withdrawn.
Election by Original Presentation
Newly submitted claim 47 is directed to an invention that is independent or distinct from the invention originally claimed for the following reasons: In the previous restriction requirement made on June 7, 2024, claims were divided between two groups: Group I (claims 22-38 which are product claims) drawn to a hydroalcoholic gel composition; and Group II (claims 39-42 which are method claims) drawn to a method of treating or alleviating one or more symptoms in a subject comprising topical administration of the composition of claim 22. In their response filed on August 22, 2024, applicant already elected (without traverse) the subject matter of Group I (product claims), and the method claims of Group II have been withdrawn. Yet, in their response dated December 1, 2025, applicant added a new claim 47, a method claim drawn to a method of treating, reducing, or alleviating psoriasis-related symptoms comprising topical administration of the composition of claim 22.
Since applicant has received an action on the merits for the originally presented invention (product claims), this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, the newly added claim 47 (a method claim) is withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
Specification
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required: Applicant amended claim 22 to recite a hydroalcoholic “oil free” gel composition. Present specification lacks antecedent basis for the term “oil free”.
Claim Objections
Claim 31 is objected to because of the following informalities: on line 2, applicant need to change “and/or” to --- or --- (because claim 22, from which claim 31 depends, recites “one or more thickener(s) or gelling agent(s)”). Appropriate correction is required.
Claim Rejections - 35 USC § 112
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.
Claim 25 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 25 (as amended) recites that the composition of claim 22 comprises no CBD oil, vegetable oil, or mineral oil “provided with the cannabidiol”. The way the claim is currently written is vague and indefinite. Do applicant mean that their hydroalcoholic gel composition (as a final product) comprises no CBD oil, vegetable oil, or mineral oil (if so, the phrase “provided with the cannabidiol” is redundant and causes confusion), or do they mean that CBD is not provided as dissolved in a carrier oil, which is CBD oil, vegetable oil or mineral oil (see pg.14, lines 10-11 of present specification)?
Appropriate correction and clarification are required.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 25 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 25 (as amended) recites that the composition of claim 22 comprises no CBD oil, vegetable oil, or mineral oil “provided with the cannabidiol”. In Paragraph 7 above, the Examiner indicated that it is unclear to the Examiner whether applicant mean that their hydroalcoholic gel composition (as a final product) comprises no CBD oil, vegetable oil, or mineral oil (in which case the phrase “provided with the cannabidiol” is redundant and confusing), or whether they mean that CBD is not provided as dissolved in a carrier oil, which is CBD oil, vegetable oil or mineral oil. In either case, claim 25 fails to further limit the subject matter of claim 1. That is, if applicant mean the former, it fails to further limit instant claim 22 because claim 22 already requires the gel composition to be oil free (i.e., the composition does not comprise any oil). If applicant meant the latter, it also fails to further limit instant claim 22 because claim 22 already recites that the cannabidiol is provided in a crystalline form (which means that the CBD is not provided as dissolved in a carrier oil, which is CBD oil, vegetable oil or mineral oil).
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim 48 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
In claim 24, from which claim 48 depends, applicant state that the cannabidiol comprises less than 1.0 wt.% of a cannabinoid selected from the group consisting of CBDV, CBDA, CBG, CBN and THC. Yet, in claim 48, applicant recite that the cannabidiol includes a cannabinoid selected from the group consisting of ≤ 1.5% CBC, ≤ 1.5% CBDA, ≤ 1.5% CBG, ≤1.5% CBN, and ≤0.1% THC. Thus, instant claim 48 fails to further limit the subject matter of claim 24.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim 36 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 36 recites that the composition of claim 22 comprises 0.01-0.03 wt.% of sodium stearoyl glutamate, and present specification indicates (see pg.20, line 29) that the sodium stearoyl glutamate is used as an O/W emulsifier, which implies that oil is present in the composition. However, since instant claim 22 (as amended) now recites an oil free composition, claim 36 (which implies the presence of oil in the composition) fails to further limit the subject matter of instant claim 22.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
Claim(s) 22-25, 27, 28, 30-32 and 48 are rejected under 35 U.S.C. 103 as being unpatentable over Stinchcomb et al (US 2010/0273895 A1) in view of Guy et al (WO 2019/207319 A1) and Shomer (WO 2004/009101 A1).
In claim 1, Stinchcomb teaches the following pharmaceutical composition:
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Stinchcomb further teaches ([0103], [0002] and claim 32) that its composition (or formulation) is a hydroalcoholic gel or a gel-like composition for topical administration.
With respect to instant component (a), in claim 2, Stinchcomb further teaches that the cannabidiol (of claim 1) is present in the amount of about 1-10 wt.% of the composition, and such range falls within instant range 0.1-10 wt.% for the amount of cannabidiol and thus teaches instant range. As to the newly added limitation “wherein the cannabidiol used in the preparation of the composition is provided in a crystalline form;”, Stinchcomb does not explicitly teach such limitation. Guy teaches (see abstract, [00212], [00220]-[00222]) a cannabidiol (CBD) preparation in crystalline form derived from botanical origin (Cannabis sativa L. plant) which is more effective in treating diseases and disorders (such as Rheumatoid arthritis and joint pain ([00194])) and reducing inflammation ([00188]) than preparations of CBD, which are synthetic or purified to the extent that no other impurities in the form of other cannabinoids are present. Guy further teaches (claim 1) that its CBD preparation has ≥ 98 wt.% CBD and ≤ 2 wt.% other cannabinoids, such as THC, CBD-C1, CBDV and CBD-C4. Since Stinchcomb teaches (claim 38, [0009] and [0051]) that its composition can be used in treating Rheumatoid arthritis and joint pain and is anti-inflammatory, it would have been obvious to one skilled in the art to use Guy’s crystalline form CBD derived from botanical origin in Stinchcomb’s pharmaceutical composition with a reasonable expectation of more effectively treating Rheumatoid arthritis, joint pain and other inflammatory diseases as taught by Guy. Thus, Stinchcomb in view of Guy renders obvious instant component (a).
With respect to instant component (b), in claims 6-7, Stinchcomb further teaches that the penetration enhancer (which can be chosen from the compounds listed in claim 6) is present in the amount of about 0.1-15 wt.% of the composition. Such range overlaps with instant range 0.5-1.5 wt.% for the amount of skin penetration enhancer, thus rendering instant range prima facie obvious. In the case “where the [claimed] ranges overlap or lie inside ranges disclosed by the prior art,” a prima facie case of obviousness would exist which may be overcome by a showing of unexpected results, In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976). Thus, Stinchcomb renders obvious instant component (b).
With respect to instant component (c), in claim 12, Stinchcomb teaches that the lower alcohol of claim 1 is ethanol or isopropyl alcohol. It would be obvious to one skilled in the art to use ethanol as Stinchcomb’s lower alcohol of claim 1 in the amount of about 15-95 wt.% with a reasonable expectation of success. Such range overlaps with instant range 10-30 wt.% for the amount of ethanol, thus rendering instant range prima facie obvious. In re Wertheim, supra. Thus, Stinchcomb renders obvious instant component (c).
With respect to instant component (d), in claims 16 and 18, Stinchcomb teaches that its pharmaceutical composition further comprises a thickening agent in the amount of about 0.1-10 wt.% of the composition. Such range overlaps with instant range 0.4-2 wt.% for the amount of the one or more thickener(s) or gelling agent(s), thus rendering instant range prima facie obvious. In re Wertheim, supra. Thus, Stinchcomb renders obvious instant component (d).
With respect to instant component (f), the water in a quantity sufficient for the composition to total 100 wt.% as recited in Stinchcomb’s claim 1 teaches instant component (f).
With respect to instant component (e), Stinchcomb’s pharmaceutical composition of claim 1 does not include 10-20 wt.% sodium chloride. Stinchcomb teaches (see claim 38) a method of treating a medical condition in a mammal by administering a therapeutically effective amount of a pharmaceutical composition, which is the same composition as described in Stinchcomb’s claim 1, to the skin of the mammal, and examples of the medical condition include Rheumatoid arthritis, psoriasis and osteoarthritis. After first stating (pg.1, lines 5-18) that it is known in the art that bathing in the Dead Sea has beneficial effect to the skin of patients suffering from different skin disorders, Shomer teaches (pg.2, lines 3-5, lines 10-14) that it has surprisingly found that with a gel form composition comprising sea salts, the same effects can be achieved as with a bath in the sea where the necessary amount of the salt is considerably smaller and that from such composition, the salts can be absorbed in the epidermis just as good as from the sea water. Shomer teaches that such gel composition ensures sufficient topical salt concentration and a long-keeping contact with the skin. Shomer thus teaches (claims 1-3) a gel form pharmaceutical composition comprising 5-25 wt.% Dead Sea salt (and further comprising starch). Shomer teaches (pg.2, lines 20-25) that such composition may also comprise other ingredients having pharmaceutical additional activity which can be absorbed to the skin and further teaches that the composition may be used for treating skin diseases or disorders, such as obstinate psoriasis, rheumatoid arthritis and osteoarthritis. Since Stinchcomb teaches that its composition (or formulation) is a hydroalcoholic gel or a gel-like composition for topical administration (Stinchcomb also teaches ([0084]) that its composition may comprise a binding agent such as starch) and since Stinchcomb also teaches that its composition can be used in treating medical condition such as Rheumatoid arthritis, psoriasis and osteoarthritis, it would have been obvious to one skilled in the art to include 5-25 wt.% Dead Sea salt (instant sodium chloride of claim 27) in Stinchcomb’s pharmaceutical composition (in the form of a hydroalcoholic gel) with a reasonable expectation of obtaining the same beneficial effects that can be achieved as with a bath in the Dead Sea and achieving an enhanced therapeutic effect in treating obstinate psoriasis, rheumatoid arthritis and osteoarthritis.
The range 5-25 wt.% for the amount of Dead Sea salt (as taught by Shomer) overlaps with instant range 10-20 wt.% for the amount of sodium chloride, thus rendering instant range prima facie obvious. In the case “where the [claimed] ranges overlap or lie inside ranges disclosed by the prior art,” a rima facie case of obviousness would exist which may be overcome by a showing of unexpected results, In re Wertheim, supra. Thus, Stinchcomb in view of Shomer renders obvious instant component (e).
With respect to instant limitation as to the hydroalcoholic gel composition being “oil-free”, Stinchcomb’s composition of claim 1 (as discussed above) does not include an oil. Also, none of Stinchcomb’s working examples include any oil. Thus, Stinchcomb teaches instant limitation (although Stinchcomb mentions certain oils in its specification ([0073], [0075], [0076]), those oils are mentioned only as optional components).
With respect to instant preamble “[a] hydroalcoholic oil free gel composition formulated for topical use to treat psoriasis”, since Stinchcomb in view of Guy and Shomer teaches all of instant components (a)-(f), Stinchcomb’s hydroalcoholic gel composition for topical administration (as modified by the teaching of Guy and Shomer) would inherently be capable of treating psoriasis – it is to be noted that instant claim 22 is a product claim, not a method claim (besides, as discussed above, Stinchcomb already teaches (claim 38) that the composition of its claim 1 can be used in treating medical conditions including psoriasis).
Thus, Stinchcomb in view of Guy and Shomer renders obvious instant claims 22, 23, 25 and 27.
With respect to instant claims 24 and 48, as already discussed above, Guy teaches (claim 1) that its CBD preparation (in crystalline form) has ≥ 98 wt.% CBD and ≤ 2 wt.% other cannabinoids (such as THC, CBD-C1, CBDV and CBD-C4) (Stinchcomb also teaches ([0046]) that any cannabinoid not intended to be administered in a therapeutically effective quantity are present in an amount of less than about 2%). The range ≤ 2 wt.% as taught by Guy or Stinchcomb overlaps with instant range of claim 24 (less than 1.0 wt.%) and with instant ranges of claim 48 (≤ 1.5% CBDV, ≤ 1.5% CBDA, ≤ 1.5% CBG, ≤ 1.5% CBN and ≤ 0.1% THC), thus rendering instant ranges prima facie obvious. In re Wertheim, supra. Thus, Stinchcomb in view of Guy and Shomer renders obvious instant claims 24 and 48.
With respect to instant claim 28, Stinchcomb teaches ([0076]) that its composition optionally comprises an emollient in the amount of about 1-30 wt.%, and among the examples for the emollient, Stinchcomb teaches glycerin. It would be obvious to one skilled in the art to include about 1-30 wt.% of glycerin (as an emollient) in Stinchcomb’s composition with a reasonable expectation of success. Stinchcomb’s range for the amount of emollient (such as glycerin) overlaps with instant range 0.5-5 wt.% for the amount of glycerine, thus rendering instant range prima facie obvious. In re Wertheim, supra. Thus, Stinchcomb in view of Guy and Shomer renders obvious instant claim 28.
With respect to instant claim 30, Stinchcomb teaches (claim 6) that its penetration enhancer can be isopropyl myristate or dimethyl sulfoxide. It would be obvious to one skilled in the art to use isopropyl myristate or dimethyl sulfoxide as Stinchcomb’s penetration enhancer with a reasonable expectation of success. Thus, Stinchcomb in view of Guy and Shomer renders obvious instant claim 30.
With respect to instant claim 31, Stinchcomb teaches ([0084]) that its composition may further comprise one or more binding agents, and among examples for the binding agents, Stinchcomb teaches cellulosic derivatives such as hydroxyethyl cellulose (instant thickener/gelling agent of claim 31) or xanthan gum (instant thickener/gelling agent of claim 31). It would be obvious to one skilled in the art to further include hydroxyethyl cellulose or xanthan gum (as the binding agent) in Stinchcomb’s composition with a reasonable expectation of success. Furthermore, Stinchcomb also teaches (claims 16-18) that its thickening agent (to be contained in its pharmaceutical composition of its claim 1) can be polymers marketed under the tradename Carbopol®, and according to present specification (pg.10, lines 17-19), such polymers are C10-C30 alkyl acrylate cross polymers (instant acrylate cross polymer of claim 31 – instant thickener/gelling agent of claim 31). Thus, Stinchcomb in view of Guy and Shomer renders obvious instant claim 31.
With respect to instant claim 32, Stinchcomb teaches (claim 21) that its composition further comprises an antioxidant. Thus, Stinchcomb in view of Guy and Shomer renders obvious instant claim 32.
Claim(s) 33 and 34 are rejected under 35 U.S.C. 103 as being unpatentable over Stinchcomb et al (US 2010/0273895 A1) in view of Guy et al (WO 2019/207319 A1) and Shomer (WO 2004/009101 A1) as applied to claim 22 above, and further in view of Wootten (WO 2019/126557 A1).
With respect to instant claim 33, as already discussed above, Stinchcomb in view of Guy and Shomer teaches a pharmaceutical composition (in the form of a hydroalcoholic gel) which contains 1-10 wt.% of cannabidiol (in crystalline form), 0.1-15 wt.% of penetration enhancer, 15-95 wt.% of ethanol, 0.1-10 wt.% of thickening agent, 5-25 wt.% Dead Sea salt (sodium chloride) and water in a quantity for the composition to obtain a total of 100 wt.%. The ranges for the cannabidiol, penetration enhancer, ethanol, thickening agent, Dead Sea salt (sodium chloride) and water overlap with instant ranges of claim 33 for the corresponding components, thus rendering instant ranges prima facie obvious. In re Wertheim, supra.
With respect to instant limitation “0.5-1.5 wt.% glycerine”, as discussed above, Stinchcomb renders obvious using glycerin (as emollient) in the amount of about 1-30 wt.%. Such range overlaps with instant range 0.5-1.5 wt.% for the amount of glycerin as recited in claim 33, thus rendering instant range prima facie obvious. In re Wertheim, supra.
Stinchcomb does not teach the use of instant extract of aloe barbadensis leaf, panthenol or retinyl palmitate. However, as evidenced by Wootten ([0090] and claims 37-39), aloe barbadensis leaf juice, retinyl palmitate and panthenol are known in the art as skin conditioning agents, which are often used in topical formulations that are useful for treating a skin disorder, such as psoriasis. Wootten teaches ([0090]) that such skin conditioning agents are used to maintain, improve or enhance a skin condition. Stinchcomb also teaches (claim 46) that its composition can be used in treating a medical condition such as psoriasis. It would have been obvious to one skilled in the art to use aloe barbadensis leaf juice, retinyl palmitate and panthenol as skin conditioning agents in Stinchcomb’s composition discussed above with a reasonable expectation of maintaining, improving or enhancing the skin condition. As to instant ranges of claim 33 for the amounts of aloe barbadensis leaf juice, retinyl palmitate and panthenol, Stinchcomb teaches ([0076]) that if a (skin) emollient (a skin conditioning agent) is used, it would be used in the amount of 5-15%. Based on such guideline given by Stinchcomb, instant ranges for the amounts of extract of aloe barbadensis leaf, panthenol and retinyl palmitate (which are skin conditioning agents or skin emollients) would have been obvious to one skilled in the art before the effective filing date of the claimed invention since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Thus, Stinchcomb in view of Guy and Shomer, and further in view of Wootten renders obvious instant claim 33 (Stinchcomb’s composition modified by the teachings of Guy, Shomer and Wootten would inherently reduce or alleviate psoriasis-related symptoms as instantly recited in claim 33. Besides, as discussed above, Stinchcomb already teaches (claim 38) that the composition of its claim 1 can be used in treating medical conditions including psoriasis).
With respect to instant claim 34, as already discussed above, Stinchcomb in view of Guy and Shomer teaches a pharmaceutical composition (in the form of a hydroalcoholic gel) which contains 1-10 wt.% of cannabidiol (in crystalline form), 0.1-15 wt.% of penetration enhancer, 15-95 wt.% of ethanol, 0.1-10 wt.% of thickening agent, 5-25 wt.% Dead Sea salt (sodium chloride) and water in a quantity for the composition to obtain a total of 100 wt.%. The ranges for the cannabidiol, penetration enhancer, ethanol, thickening agent, Dead Sea salt (sodium chloride) and water overlap with instant ranges of claim 33 for the corresponding components, thus rendering instant ranges prima facie obvious. In re Wertheim, supra.
With respect to instant limitation “0.1-0.3 wt.% glycerine”, as discussed above, Stinchcomb renders obvious using glycerin (as emollient). Stinchcomb also teaches that its composition may contain one or more emollients in the amount of 1-30 wt.%. Instant range (0.1-0.3 wt.%) for the amount of glycerine (alone) would have been obvious to one skilled in the art before the effective filing date of the claimed range since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, supra.
Stinchcomb does not teach the use of instant extract of aloe barbadensis leaf, panthenol or retinyl palmitate. However, as evidenced by Wootten ([0090] and claims 37-39), aloe barbadensis leaf juice, retinyl palmitate and panthenol are known in the art as skin conditioning agents, which are often used in topical formulations that are useful for treating a skin disorder, such as psoriasis. Wootten teaches ([0090]) that such skin conditioning agents are used to maintain, improve or enhance a skin condition. It would be obvious to one skilled in the art to use aloe barbadensis leaf juice, retinyl palmitate and panthenol as skin conditioning agents in Stinchcomb’s composition with a reasonable expectation of maintaining, improving or enhancing the skin condition. As to instant range for the amount of the aloe barbadensis leaf juice, retinyl palmitate and panthenol, Stinchcomb teaches ([0076]) that if (skin) emollient (a skin conditioning agent) is used, it would be used in the amount of 5-15%. Based on such guideline given by Stinchcomb, instant ranges for the amounts of extract of aloe barbadensis leaf, panthenol and retinyl palmitate would have been obvious to one skilled in the art before the effective filing date of the claimed invention since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, supra.
With respect to instant 0.01-0.03 wt.% of antioxidant, Stinchcomb teaches (claims 21 and 23) that its composition may further comprise an antioxidant in the amount of 0.01-1 wt.% of the composition. Such range overlaps with instant range 0.01-0.03 wt.% for the amount of antioxidant, thus rendering instant range prima facie obvious. In re Wertheim, supra.
Thus, Stinchcomb in view of Guy and Shomer, and further in view of Wootten renders obvious instant claim 34.
Response to Arguments
With respect to instant 103 rejections over Stinchcomb in view of Guy and Shomer, applicant argue that because the claimed formulation is oil-free, CBD is not trapped under an oily barrier and can penetrate efficiently and argue that such controlled, epidermal-level synergy is not taught in any prior art. Applicant argue that in the claimed oil-free hydroalcoholic delivery system, ethanol (10-30%) gently opens the stratum corneum and the penetration enhancer transports CBD into the epidermis, precisely where psoriatic keratinocyte hyperproliferation occurs. Applicant argue that oils form an occlusive membrane that blocks CBD uptake and thus the claimed oil free gel allows for a controllable delivery of CBD to a targeted penetration depth for alleviating psoriasis related issues. However, as already discussed above, Stinchcomb’s composition of claim 1 does not include an oil, and none of Stinchcomb’s working examples include any oil. Thus, Stinchcomb teaches instant hydroalcoholic oil free gel composition. Furthermore, Stinchcomb teaches that its ethanol can be present in the amount of 15-95 wt.%, which range overlaps with instant range 10-30%, thus rendering instant range prima facie obvious. In re Wertheim, supra.
Applicant argue that Stinchcomb’s transdermal CBD delivery systems
are not intended for the treatment of psoriasis because: Stinchcomb’s formulations do not disclose or suggest dermatologically active excipients such as Dead Sea salt, aloe, panthenol, or tocopherol; Stinchcomb fails to teach or suggest keratinocyte hyperproliferation, pruritus, scaling, erythema, and the mechanisms associated with psoriasis; and Stinchcomb’s text provides no clinical dermatology data. Applicant argue that the claimed embodiments ensure gentle, tolerable, controlled epidermal delivery of cannabidiol (CBD) to alleviate psoriatic plaque, which stands in contrast to Stinchcomb's high-flux, deep-penetration drug delivery systems. Applicant thus argue that Stinchcomb is technically, functionally and therapeutically unrelated to the claimed subject matter. The Examiner disagrees. First of all, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981). Where a rejection of a claim is based on two or more references, a reply that is limited to what a subset of the applied references teaches or fails to teach, or that fails to address the combined teaching of the applied references may be considered to be an argument that attacks the reference(s) individually. Although Stinchcomb does not teach the use of sodium chloride in its pharmaceutical composition, the Examiner already established above in detail that Stinchcomb in view of Shomer renders it obvious to include 5-25 wt.% Dead Sea salt in Stinchcomb’s pharmaceutical composition (see Paragraph 13 above). As discussed above, Stinchcomb’s composition of as modified by Shomer’s teaching to further include Dead Sea salt teaches all of instant components (a)-(f) and thus would inherently be capable of treating psoriasis as recited in the pre-amble of claim 22 (it is not required that Stinchcomb teaches or suggests keratinocyte hyperproliferation, pruritus, scaling, erythema and the mechanisms associated with psoriasis or provides clinical dermatology data as long as Stinchcomb’s composition as modified by the teachings of Shomer is capable of treating psoriasis unless proven otherwise by applicant). Besides, as already discussed above, Stinchcomb already teaches that its hydroalcoholic gel composition can be used to treat medical conditions including psoriasis.
Applicant points out that Stinchcomb incorporates Novak reference, which appears to teach the advancement in cannabinoid (CBN) synthesis methodology to provide a more efficient route to cannabinol for research and argue that the Novak reference does not provide any teaching or suggestion towards formulations or
medical use. Applicant argue that that the combined teaching of Novak and
Stinchcomb is a lab method for producing cannabinol (CBN) and does not teach or suggest the cannabidiol (CBD), psoriasis, inflammation or pain relief and also argue that Novak provides no clinical results and no therapeutic application and thus, Novak is chemically and functionally unrelated to the claimed CBD topical application. However, The Examiner does not understand what point applicant is trying to make here because Stinchcomb incorporates Novak simply for the synthesis of cannabidiol, and instant 103 rejection is not based on Stinchcomb in view of Novak, but on Stinchcomb in view of Guy and Shomer (Novak was not even mentioned in the rejection).
Applicant argue that application of Stinchcomb's transdermal CBD systems to a psoriatic skin that is damaged, inflamed, sensitive, and often fissured, would cause intense stinging, burning, and barrier disruption and that such levels of ethanol are intended to maximize systemic absorption, not treat compromised psoriatic plaques. Applicant argue that Stinchcomb’s systems are clinically intolerable for psoriasis patients and would worsen symptoms, not relieve them. Applicant argue that in contrast to Stinchcomb, the claimed Psoriasis Gel uses only 10-30% ethanol, is oil-free, and
allows for the further incorporation of tolerable soothing agents (panthenol, aloe,
glycerine) and further allows for the presence of sodium chloride (e.g. Dead Sea salt) in
the claimed range to stabilize and calm inflamed skin. Applicant argue that the claimed formulation is furthermore applicable for daily use on sensitive, painful psoriatic plaques, which is fundamentally different from Stinchcomb's harsh, deep-penetrating trans-dermal delivery approach. The Examiner disagrees. Since Stinchcomb teaches that its ethanol can be present in the amount that ranges anywhere from 15 wt.% to 95 wt.%, and since Stinchcomb lists medical conditions that can be treated using its hydroalcoholic (oil free) gel composition, one skilled in the art would be able to determine the optimal amount of ethanol as well as to determine the appropriate soothing agents and other necessary additives depending on the specific medical condition being treated.
As to the Shomer reference, applicant argue that the reference does not appear to teach or suggest CBD, cannabinoids, penetration enhancers, ethanol, nor a hydroalcoholic system and also argue that Shomer’s formulations appear to be oil-based, whereas the claimed Psoriasis Gel is oil-free. Applicant argue that such a difference is critical, because oils form a blocking membrane on the skin that inhibits CBD penetration. Applicant further argue that Shomer's gels are merely skin-soothing salt gels and that there is no teaching or suggestion in Shomer regarding CBD delivery, a penetration enhancer, hydroalcoholic penetration, epidermal CBD uptake, clinical CBD effects including psoriasis-specific mechanisms (itch, scaling, cytokines). However, instant 103 rejection is based on Stinchcomb in view of Guy and Shomer, not on Shomer alone, and applicant cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. In re Keller, supra. As already discussed above, Shomer first teaches that it is known in the art that bathing in the Dead Sea has beneficial effect to the skin of patients suffering from different skin disorders. Shomer then teaches that using a gel form composition comprising sea salts (paraffin oil is not a required component in Shomer’s gel form composition) gives the same effects that can be achieved as with a bath in the sea and teaches that such gel form composition may be used for treating skin diseases or disorders including obstinate psoriasis, rheumatoid arthritis and osteoarthritis. Since Stinchcomb teaches that its hydroalcoholic gel composition can be used in treating medical condition such as Rheumatoid arthritis, psoriasis and osteoarthritis, one skilled in the art would have found it obvious to include 5-25 wt.% Dead Sea salt in Stinchcomb’s hydroalcoholic gel composition with a reasonable expectation of obtaining the same beneficial effects that can be achieved as with a bath in the Dead Sea and achieving an enhanced therapeutic effect in treating obstinate psoriasis, rheumatoid arthritis and osteoarthritis.
Applicant argue that Wootten teaches cosmetic combinations, rather than specific CBD applications, and thus, the context provided does not directly address CBD. Applicant also argue that Wootten focuses on developing cosmetic formulations that incorporate CBD combined with other plant extracts and oils, from which the present invention is free and argue that Wootten’s teachings are not centered on CBD itself. Applicant argue that Wooten’s formulation is intended for treating skin damage and signs of aging by improving pore size, diminishing bacterial damage, reducing problematic skin areas, protecting against sun damage, and maintaining or enhancing skin tone. Applicant argue that Wootton discloses compositions are mild cosmetic lotions, not pharmaceutical topical gels achieving CBD skin penetration. Applicant thus argue that Wootton is technically, chemically, and therapeutically unrelated and cannot anticipate the claimed CBD hydroalcoholic oil-free gel system for treating psoriasis. However, again, instant 103 rejection on claims 33 and 34 is based on Stinchcomb in view of Guy and Shomer, and further in view of Wootten, not on Wootten alone, and applicant cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. In re Keller, supra. The Examiner already established in Paragraph 14 above that Stinchcomb in view of Guy and Shomer renders obvious instant claims 33 and 34. Also, in instant 103 rejection on claims 33 and 34, Wootten is being used merely as an evidentiary reference to show that aloe barbadensis leaf juice, retinyl palmitate and panthenol are known in the art as skin conditioning agents often used in topical formulations, which can be used for treating skin disorders, including psoriasis (see claims 37-39) (Wootten clearly teaches in many places of its specification that its compositions can used for a subject suffering from a skin disorder, such as psoriasis).
For the reasons stated above, instant 103 rejections over Stinchcomb in view of Guy and Shomer still stand.
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/SIN J LEE/
Primary Examiner, Art Unit 1613
March 27, 2026
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