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 .
Note to Applicant
There currently is not a valid power of attorney in this application. The applicant is encouraged to rectify the issue noted in the Notice Regarding Power of Attorney mailed April 4, 2025 to facilitate future communication during prosecution.
Election/Restrictions
Applicant’s election without traverse of Group II drawn to a method of making a reservoir style dermal patch. The applicant states that the election of group II is inclusive of claim 67 as a “required base composition’ and then states in the species election that the elected species includes beta-caryophyllene and not CBD (presumably representing cannabidiol). Confusingly, the applicant accompanies the election with an amendment that deletes all the embodiments from claim 67 that recite beta-caryophyllene, such that this claim does not require the elected species. Thus the meaning of the applicant’s statement that claim 67 is a “required base composition” is unclear. As a result, the applicant’s election of species chosen from the possible options amongst the recited “at least one of eugenol, capsaicin, cannabidiol (CBD), cannabidiolic acid (CBDA), diclofenac, and b-caryophyllene (BCAP)” is viewed as beta-caryophyllene without cannabidiol.
The restriction is made FINAL
During the course of searching, a dermal patch of group II was encountered, thus this invention group is rejoined, in as much as it reads on the election of species. The applicant has listed numerous dependent claims that add functional limitations to the scope of their parent claim (e.g., claim 70) as ‘withdrawn’. There is no clear indication that this action was made in error, thus they will be withdrawn, in light of the indication by the applicant. In the case of some other claims, such as claims 68 and 79, their listing as ‘withdrawn’ by the applicant is not consistent with the election because they recite components that are not impacted by the election or recite a compound class in which the elected compound is included. Therefore such claims will not be withdrawn. Claims 67, 70, 72-75, 91, 95-110 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention and species, there being no allowable generic or linking claim.
Abstract
The abstract of the disclosure is objected to because it does not appear on a separate page. Correction is required. See MPEP § 608.01(b).
The abstract of the disclosure does not commence on a separate sheet in accordance with 37 CFR 1.52(b)(4) and 1.72(b). A new abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text.
Claim Objections
Claim 111 is are objected to because of the following informalities: Claim 111 includes a random recitation of “Docket No. RBI-010500-PRO 84” in step (iv). Claim 111 recites “two strips (first strip and second strip)”. The parenthetical recitation is seemingly present as a synonym for “two strips”. Since the claim later recites “the first strip” and “the second strip”, the initial recitation of these components should not be parenthetical.
Appropriate correction is required.
Duplicate Claim Warning
Applicant is advised that should claim 79 be found allowable, claim 81 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. The same is true for claims 82 and 83, respectively. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
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 64-66 and 68 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural phenomenon without significantly more. The claims recite a “pharmaceutical formulation…that comprises at least one of eugenol, capsaicin, cannabidiol (CBD), cannabidiolic acid (CBDA), diclofenac, and b-caryophyllene (BCAP), wherein said pharmaceutical formulation further may comprise of a penetration enhancer”. The election of species limits this composition to include b-caryophyllene, but not cannabidiol and may also include limonene as a penetration/permeation enhancer. The terminology “permeation” and “penetration” is employed interchangeably by the instant disclosure (see specification paragraph 37 and claim 65). This judicial exception is not integrated into a practical application because b-caryophyllene in combination with limonene without cannabidiol are naturally occurring compounds found together in multiple varieties of peppers and their extracted essential oil (see Jirovetz et al. (Journal of Chromatography 2002 A976:265-275, abstract, page 266, and table 1). While the composition recites a functional limitation of being capable of reducing menstrual pain when applied to the skin, this function is not linked to any additional structure. Thus the claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because they do not require any more than the naturally occurring combination of components. Therefore the claims embrace non-statutory subject matter.
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 115 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.
Regarding claim 115, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 64 and 66 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sköld et al. (Food and Chemical Toxicology 2006 44:538–545) as evidenced by Ghelardini et al. (Il Farmaco 2001 56:387-389).
Sköld et al. disclose b-caryophyllene in petrolatum as a topically applied composition (see page 540 first column second paragraph and table 4). The compositions contain b-caryophyllene at up to 13.6% (see table 4). Cannabidiol and an active compound as recited in instant claim 66 are not recited as present or required. Ghelardini et al. disclose b-caryophyllene as a topical local anesthetic (see abstract and page 387). Instant claim 64 recites the functional property and intended use of “when applied to the skin, is capable of reducing menstrual pain”. No structure other than the presence of a claimed compound is recited or disclosed as being necessary to achieve this outcome. According to MPEP 2112.01, “A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present.” This treatment results from In re Spada, which states that, “Products of identical chemical composition can not have mutually exclusive properties.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Here the prior art discloses the instantly recited composition and compound, therefore the functional limitation is also met, absent evidence to the contrary. Thus claims 64 and 66 are anticipated by Sköld et al. as evidenced by Ghelardini et al.
Claims 64-66 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Jirovetz et al. (Journal of Agricultural Food Chemistry 2006 54:6303-6307 – henceforth Jirovetz B) as evidenced by Ghelardini et al.
Jirovetz B discloses a clove oil and its components include limonene (penetration enhancer) and b-caryophyllene at 17.4% (see table 1). Ghelardini et al. disclose b-caryophyllene as a topical local anesthetic (see abstract and page 387). Cannabidiol and an active compound as recited in instant claim 66 are not recited as present or required. Instant claim 64 recites the functional property and intended use of “when applied to the skin, is capable of reducing menstrual pain”. No structure other than the presence of a claimed compound is recited or disclosed as being necessary to achieve this outcome. According to MPEP 2112.01, “A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present.” This treatment results from In re Spada, which states that, “Products of identical chemical composition can not have mutually exclusive properties.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Here the prior art discloses the instantly recited composition and compound, therefore the functional limitation is also met, absent evidence to the contrary. Thus claims 64-66 are anticipated by Jirovetz et al. as evidenced by Ghelardini et al.
Claims 64 and 66 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Aung-Din (US PGPub No. 2018/0049994).
Aung-Din disclose a composition with caryophyllene that is topically applied in an amount sufficient to yield a neuro-effective therapy, where the caryophyllene is b-caryophyllene (see claim 7). Caryophyllene is detailed as treating pain (see paragraphs 12-14). Cannabidiol and an active compound as recited in instant claim 66 are not recited as present or required. Instant claim 64 recites the functional property and intended use of “when applied to the skin, is capable of reducing menstrual pain”. No structure other than the presence of a claimed compound is recited or disclosed as being necessary to achieve this outcome. According to MPEP 2112.01, “A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present.” This treatment results from In re Spada, which states that, “Products of identical chemical composition can not have mutually exclusive properties.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Here the prior art discloses the instantly recited composition and compound, therefore the functional limitation is also met, absent evidence to the contrary. Thus claims 64 and 66 are anticipated by Aung-Din.
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 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 64-66, 68-69, 71,79, and 81-85 are rejected under 35 U.S.C. 103 as being unpatentable over Aung-Din.
Aung-Din disclose a composition with caryophyllene that is topically applied in an amount sufficient to yield a neuro-effective therapy, where the caryophyllene is b-caryophyllene (see abstract and claim 7; instant claim 64). They teach the compositions more specifically to treat various types of pain (see paragraphs 12-14; instant claim 79 and 81). Caryophyllene is a terpene compound that is found in essential oils in various plants and b-caryophyllene is the predominant component of West African pepper essential oil, where it usually occurs as in combination with the caryophyllenes isocaryophyllene and α-humulene (see paragraph 57). The term caryophyllene refers to b-caryophyllene, its isomers, metabolites, salts, and adducts (see paragraph 60). An exemplary cream composition is detailed to include caryophyllene, phenoxyethanol (preservative), and ascorbyl palmitate (antioxidant) (see paragraph185 and example 1; instant claim 68 and 85). They go on to teach formulation of the composition with caryophyllene in a reservoir as part of a reservoir type transdermal patch (see paragraph 196; instant claims 69, 71). Aung-Din teaches dosing of the composition such that 30 mg (about 35 mg) of caryophyllene is provided at the treatment site (see example 3; instant claims 82-83). Envisioned permeation enhancers they detail in the composition include isopropyl myristate, dimethyl sulfoxide, propylene glycol, and oleic acid (see paragraph 167; instant claim 65). Cannabidiol and an active compound as recited in instant claim 66 and 69 are not recited as present or required. While a full example of each embodiment that follows from the teachings of Aung-Din is not detailed, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to formulate their exemplary topical composition with caryophyllene in a reservoir as part of a reservoir type transdermal patch with b-caryophyllene as the caryophyllene because they suggest this form of caryophyllene. It would follow to also include the preservative, antioxidant, and permeation enhancer compounds that they explicitly name and exemplify in the composition because they suggest to do so. Instant claim 64 recites the functional property and intended use of “when applied to the skin, is capable of reducing menstrual pain”. No structure other than the presence of a claimed compound is recited or disclosed as being necessary to achieve this outcome. According to MPEP 2112.01, “A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present.” This treatment results from In re Spada, which states that, “Products of identical chemical composition can not have mutually exclusive properties.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Here the prior art discloses the instantly recited composition and compound, therefore the functional limitation is also met, absent evidence to the contrary. Thus claims 64-66, 68-69, 71,79, and 81-85 are obvious over Aung-Din.
Claims 64-66, 68-69, 71,79, 81-85, and 111-115 are rejected under 35 U.S.C. 103 as being unpatentable over Aung-Din as applied to claims 64-66, 68-69, 71,79, and 81-85 above, and further in view of Zaffaroni (US Patent No. 3,598,122) and Tucker (US Patent No. 6,871,477).
Aung-Din renders obvious a drug-in-reservoir transdermal patch comprising a composition according to claims 64-66, 68-69, 71,79, and 81-85, where b-caryophyllene is present along with a preservative, but cannabidiol is not present (see instant claim 112-113 and115). They point to Zaffaroni as a design for the transdermal dermal patches they envision (see paragraph 195). Details of producing the patch as instantly claimed are not detailed.
Zaffaroni teaches a transdermal patch configuration to have a reservoir pouch that holds a composition with an active compound to be delivered transdermally. The top of the pouch is overlaid with a permeable membrane and the bottom of the pouch is overlaid with a backing layer, as shown below in figure 3
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(see column 3 lines 13-19). Here component 12 is the pouch forming the reservoir, component 15 is the active containing composition, component 11 is the backing layer, and component 16 is the permeable membrane. The reservoir pouch material is also permeable to the active (see column 6 lines 38-46). Zaffaroni further detail preparing the pouch reservoir by sealing/closing a film material around the active agent composition and then bonding a sheet of the other layer components to the already formed pouch (see column 6 line 71-column 7 line 4; instant claim 111).
Tucker et al. teach the production of drug-in-reservoir type transdermal patches with a liquid or gel drug composition in the reservoir (see abstract, column 2 line 66-67, and column 3 line 62-column 4 lines 3). The reservoir pouches are produced via a continuous process where two strips of film material are fed, facing and in contact with each other at the same rate, to a machine with heat sealing rollers (see column 2 line 44-column 2 line 18). A film tube is formed, clamped with heated transverse clamps to create pockets that are filled with active composition via an inserted tube, then sealed as the film strips/tube film progresses, as instantly claimed (see column 5 lines 19-60; instant claim 111). The process line is depicted below in the figure where components 13-15 are heat sealing rollers, components 2 and 7 are the film strips, components 21 and 22 are the transverse clamps, components 16 and 17 are sealed edges of the strips to form the film tube, filling tubes that are not shown are inserted in the pocket/pouch components 18 and 19 prior to sealing of the pouch via the transverse clamps (see column 5 lines 19-60).
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Tucker et al. teach their vertically run, continuous process as beneficial for permitting the loading of a liquid fill material without the handling problems known to be encountered in horizontally and compartmentalized processes (se column 1 line 52-column 2 line 8). They additionally detail an active impermeable backing layer heat sealed to a permeable layer in such patches (see column 3 lines 6-23).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to prepare the drug-in-reservoir device of Aung-Din based on their teachings that point to the configuration of Zaffaroni, where a sealed pouch of liquid/gel active agent composition is attached to and sandwiched between a permeable membrane layer and a backing layer. It follows that a preservative would also be included in the drug composition as suggested by Aung-Din. Additionally, it would have been obvious to produce the reservoir pouch according to the method of Tucker then apply the permeable membrane and backing layers subsequently because their continuous reservoir pouch creation and loading process for the fill material is beneficial over other known processes. Further, Tucker details the dermal patches with the backing layer and permeable membrane sealed around their periphery, thus this configuration would have been obvious to apply as a known option for further securing these components around the reservoir. Therefore claims 64-66, 68-69, 71,79, 81-85, and 111-115 are obvious over Aung-Din in view of Zaffaroni and Tucker.
Claims 64-66, 68-69, 71,79, 81-85, and 111-116 are rejected under 35 U.S.C. 103 as being unpatentable over Aung-Din in view of Zaffaroni and Tucker as applied to claims 64-66, 68-69, 71,79, 81-85, and 111-115 above, and further in view of Chang et al. (US Patent No. 4,849,224).
Aung-Din in view of Zaffaroni and Tucker render obvious the limitations of instant claims 64-66, 68-69, 71,79, 81-85, and 111-115, where the permeable membrane layer is a heat sealable film. A particular instantly claimed material is not explicitly detailed for this component.
Chang et al. teach a heat sealable material for a membrane and backing layer for a drug-in-reservoir transdermal patch (see abstract). They detail an example with the membrane is a porous polypropylene (see column 6 lines 4-7).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to select the porous polypropylene of Chang et al. as the membrane layer of Aung-Din in view of Zaffaroni and Tucker. This modification would have been obvious as the simple substitution of one known element for another in order to yield a predictable outcome (e.g., generic porous membrane vs. specific porous membrane). Therefore claims 64-66, 68-69, 71,79, 81-85, and 111-116 are obvious over Aung-Din in view of Zaffaroni, Tucker, and Chang et al.
Conclusion
No claim is allowed.
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/CARALYNNE E HELM/ Examiner, Art Unit 1615