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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 10/2/2025 has been entered.
Response to Arguments
Applicant’s response from 10/2/2025 is acknowledged.
Claim Rejections - 35 USC § 103
Applicant has amended the claims, and made arguments against the claims as amended. In view of Applicant’s claim amendments, a modified rejection has been made below.
The Examiner further notes the following regarding Applicant’s arguments. Applicant has taken the position that: “As noted previously, a bioenhancer enhances bioavailability and bioefficacy of a particular drug without any pharmacological activity on its own whereas a penetration enhancer is an excipient that aids in the delivery of an active agent into and/or through the stratum corneum. None of the cited references teach, suggest, or motivate to include a bioenhancer. Accordingly, the instant claimed composition could not have been obvious to one skilled in the art.” The Examiner disagrees. As the office action provides: “Sinai discloses a composition comprising a therapeutically effective amount of Cannabidiol (CBD) or a derivative thereof, for use in relieving a subject suffering from fibromyalgia syndrome symptoms, wherein the concentration of said CBD is in the range of about 2% to about 85%. (claim 88 and 89). The composition is administered in a manner selected from the group consisting of: intranasal, transdermal, intradermal, topical, intravenous, oral, and any combination thereof, in combination with at least one therapeutic agent selected from the group comprising of quercetin (Applicant’s claimed P-glycoprotein bioenhancer), gabapentin, paracetamol, tramadol, codeine (further analgesic agents, according to Applicant’s claims 9 and 18), and formulated in a dosage form selected from oil (i.e. lipid-based). (claim 92, [0030], [0032]). ”As the Federal Circuit holds, the elements must be arranged as required by the claim, but this is not an ipsissimis verbis test, i.e., identity of terminology is not required. In re Bond, 910 F.2d 831, 15 USPQ2d 1566 (Fed. Cir. 1990). See also MPEP 2131.”
Further to Applicant’s subsequent arguments the Examiner also reminds Applicant that it is impermissible to attack references singly when the Examiner relies upon the combined teachings of the references, nor may they attack a reference for not teaching a limitation of the claim when the Examiner has explicitly relied upon another reference as teaching that limitation. See In re Kotzab, 217 F.3d 1365, 1370 (Fed. Cir. 2000)).
Regarding Applicant’s arguments pertaining to an isolated cannabinoid, the Examiner draws again Applicant’s attention to the office action, which provides in relevant part: “Stinchcomb recites that “one embodiment described herein, the cannabinoid, or mixture of cannabinoids, is obtained from the extract from of a natural source, such as plants from the cannabis genus (e.g., Cannabis sativa, Cannabis indicia and Cannabis ruderalis)”, or in an alternative embodiment- from synthetic chemical reactions. ([0045]).”
Double patenting
Applicant has not addressed the rejection. In view of Applicant’s claim amendments in the co-pending application the rejection has been modified.
Claim Rejections - 35 USC § 101
Applicant’s response argues that the CBDA is in isolated and in a defined concentration, but presents no argument to address to address how this concentration somehow provides a “marked” change in its characteristics. As the office action provides: “Further, the recitation of a specific percent range of the Cannabis plant-isolated cannabidiol, cannabidiol isomer, or cannabidiol analog and of the bioenhancer does not add a “marked” change in characteristics of the Cannabis plant-isolated cannabidiol, cannabidiol isomer, or cannabidiol analog and of the bioenhancer found in nature, because the additional presence of a pharmaceutically acceptable carrier, excipient, diluent, reagent, or combination thereof does not change the structure, function, or other properties of the Cannabis plant-isolated cannabidiol, cannabidiol isomer, or cannabidiol analog and of the bioenhancer in any marked way. The Cannabis plant-isolated cannabidiol, cannabidiol isomer, or cannabidiol analog and of the bioenhancer retain their naturally occurring structure and properties (e.g. anti-inflammatory effects, and penetration enhancement, respectively) is in the claimed formulation with a pharmaceutically acceptable carrier, excipient, diluent, reagent, or combination thereof which also retains its naturally occurring structure and properties (e.g., solubility). There are no other exceptions in the claim, which add significantly more.”
Claim Rejections - 35 USC § 101
Applicant’s response argues that the CBDA is in isolated and in a defined concentration, but presents no argument to address to address how this concentration somehow provides a “marked” change in its characteristics. As the office action provides: “Further, the recitation of a specific percent range of the Cannabis plant-isolated cannabidiol, cannabidiol isomer, or cannabidiol analog and of the bioenhancer does not add a “marked” change in characteristics of the Cannabis plant-isolated cannabidiol, cannabidiol isomer, or cannabidiol analog and of the bioenhancer found in nature, because the additional presence of a pharmaceutically acceptable carrier, excipient, diluent, reagent, or combination thereof does not change the structure, function, or other properties of the Cannabis plant-isolated cannabidiol, cannabidiol isomer, or cannabidiol analog and of the bioenhancer in any marked way. The Cannabis plant-isolated cannabidiol, cannabidiol isomer, or cannabidiol analog and of the bioenhancer retain their naturally occurring structure and properties (e.g. anti-inflammatory effects, and penetration enhancement, respectively) is in the claimed formulation with a pharmaceutically acceptable carrier, excipient, diluent, reagent, or combination thereof which also retains its naturally occurring structure and properties (e.g., solubility). There are no other exceptions in the claim, which add significantly more.”
Claims 21, 22, 25-33 and 36-41 are pending, and have been examined herewith.
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.
Claims 21, 22, 25-33 and 36-41 are rejected under 35 U.S.C. 103 as being unpatentable over US 20100273895 to Stinchcomb et al. (“Stinchcomb”, of record), and further in view of US 2018/0116998 A1 to Sinai et al. (“Sinai”, of record) alone, or further in view of US 2016/0235661 A1 to Changoer et al. (“Changoer”, of record).
Stinchcomb claims a pharmaceutical composition comprising: a. cannabidiol present in an amount of about 0.1% to about 20% (wt/wt) of the composition; b. a first penetration enhancer (bioenhancer) present in an amount of about 0.1% to about 20% (wt/wt) of the composition; and c. water in a quantity sufficient for the composition to total 100% (wt/wt). (claim 45).
Applicant’s claims recite a Cannabis plant isolated cannabidiol. Stinchcomb recites that “one embodiment described herein, the cannabinoid, or mixture of cannabinoids, is obtained from the extract from of a natural source, such as plants from the cannabis genus (e.g., Cannabis sativa, Cannabis indicia and Cannabis ruderalis)”, or in an alternative embodiment- from synthetic chemical reactions. ([0045]).
Stinchcomb claims a method of treating a medical condition in a mammal comprising the steps of: a. providing a pharmaceutical composition comprising: i. an active pharmaceutical agent consisting essentially of cannabidiol present in an amount of about 0.1% to about 20% (wt/wt) of the composition; ii. an alcohol present in an amount of about 15% to about 95% (wt/wt) of the composition; wherein the alcohol is selected from the group consisting of ethanol, isopropyl alcohol and mixtures of the foregoing; iii. a first penetration enhancer present in an amount of about 0.1% to about 20% (wt/wt) of the composition; wherein the first penetration enhancer is selected from the group consisting of: ethyl oleate, isopropyl myristate, butyl stearate. (claim 46).
The office action previously noted that this falls within the scope of Applicant’s claimed bioenhacer “lipid-based systems” of claims 27 and 38 because these are fatty acid triglycerides, and of Applicant’s claimed amount for it. To that end, Stinchcomb further discloses that “Aliphatic fatty acid esters enhance penetration by increasing diffusivity in the stratum corneum and/or the partition coefficient. In addition, certain aliphatic fatty acid esters, such as IPM, enhance penetration by directly acting on the stratum corneum and permeating into the liposome bilayers thereby increasing fluidity. Alkyl fatty acid esters, such as ethyl acetate, butyl acetate, methyl acetate, methylvalerate, methylpropionate, diethyl sebacate, ethyl oleate, butyl stearate and methyl laurate, can act as penetration enhancers.” ([0063]). Stinchcomb also discloses on its list of penetration enhancers some linear fatty acids, such as oleic acid, which is another example of lipid-based systems. ([0063]). To take “butyl stearate” as a non-limiting example, it is one such solid lipid, and therefore the rejection over claims 27 and 38 continually applies for a subset of lipids within “lipid-based systems”.
Stinchcomb discloses further ethyl laurate, diisopropyl adipate, glyceryl monolaurate (i.e. a humectant, according to Applicant’s claims 28 and 39), diethylene glycol monoethyl ether, alkylaryl ethers of polyethylene oxide, polyethylene oxide monomethyl ethers, polyethylene oxide dimethyl ethers, dimethyl sulfoxide, glycerol (a further ingredient according to Applicant’s claims 29 and 40), ethyl acetate, acetoacetic ester, N-alkylpyrrolidone, and terpenes; and iv. water in a quantity sufficient for the composition to total 100% (wt/wt); and b. administering a therapeutically effective amount of the composition to the skin of the mammal to treat a medical condition; and wherein the medical condition is selected from the group consisting of: dermatitis, contact dermatitis, eczema, bullous dermatitis herpetiformis, exfoliative dermatitis and seborrheic dermatitis. (claim 46).
Per Stincomb, cannabiodiol may be in any suitable form for administration to a mammal such as in the form of a free base, free acid, salt, hydrate, anhydrate, enantiomer, isomer, tautomer, polymorph, or the like. ([0053]). Suitable acids for preparing acid addition salts include both organic acids, e.g., acetic acid, propionic acid, glycolic acid, pyruvic acid, oxalic acid, malic acid, malonic acid, succinic acid, maleic acid, fumaric acid, tartaric acid, citric acid, benzoic acid, cinnamic acid, mandelic acid, methanesulfonic acid, ethanesulfonic acid, p-toluenesulfonic acid, salicylic acid, and the like, as well as inorganic acids, e.g., hydrochloric acid, hydrobromic acid, sulfuric acid, nitric acid, phosphoric acid, and the like. ([0056]).
In one embodiment, the formulation is a gel, gel-like composition, an ointment, a cream or a patch. ([0103]). It can further comprise finely divided solids, i.e. a solid filler. ([0079]).
Per Stinchcomb, "cannabidiol" refers to cannabidiol; cannabidiol prodrugs; pharmaceutically acceptable derivatives of cannabidiol, including pharmaceutically acceptable salts of cannabidiol, cannabidiol prodrugs, and cannabidiol derivatives. ([0045]). This alone discloses the possible presence of more than just cannabidiol. Further, Stinchcomb’s transitional phrase “comprising” in the claims does not preclude the presence of other cannabinoids. Stinchcomb even further explicitly contemplates a further embodiment wherein the composition comprises (a) cannabidiol present in the amount of about 1% to about 98% (wt/wt). ([0047]). Stinchcomb discloses elsewhere the presence of other cannabinoids in the composition as well. “Described herein are compositions comprising cannabinoids, including cannabidiol and penetration enhancers that when transdermally administered to a mammal, such as a human, provide a therapeutic systemic concentration of cannabidiol.” ([0013]). In all embodiments and examples described herein containing cannabidiol, one or more prodrugs of cannabidiol or other cannabinoid may be included with the cannabidiol. ([0052]). All of this summarily provides disclosure supporting a composition, according to Applicant’s independent claims, comprising: “a Cannabis plant-isolated cannabidiol, cannabidiol isomer, or cannabidiol analog having a concentration of about 1% (w/w) to about 30% (w/w), relative to the total weight of the composition, wherein the isolated cannabidiol, cannabidiol isomer, or cannabidiol analog is present in an amount of about 80% (w/w) to about 100% (w/w) of the total cannabinoids in the composition.
Even where Stinchcomb discloses a further embodiment, in which the cannabinoid is “substantially free from impurities”, even in this embodiment Stinchcomb defines that “’substantially free of impurities’ shall mean that impurities, including any cannabinoid not intended to be administered in a therapeutically effective quantity, are present in an amount by weight of the composition of less than about 10%, less than about 5%, less than about 4%, less than about 3%, less than about 2%, less than about 1%, or less than about 0.1%.” ([0046]). Assuming, per Applicant’s independent claims, the total cannabidiol is about 100% of the total cannabinoids in the composition. Stinchcomb defines “about” very broadly. “As used herein, the terms "about" and "approximately" when referring to a numerical value shall have their plain and ordinary meanings to a person of ordinary skill in the art to which the disclosed subject matter is most closely related or the art relevant to the range or element at issue. The amount of broadening from the strict numerical boundary depends upon many factors. For example, some of the factors which may be considered include the criticality of the element and/or the effect a given amount of variation will have on the performance of the claimed subject matter, as well as other considerations known to those of skill in the art.” ([0192]). Applicant defines it as: “The word “about” when immediately preceding a numerical value means a range of plus or minus 10% of that value.” ([0027]). So, this disclosure of Stinchcomb encompasses within its meaning wherein the cannabinoid CBL is present alone with no presence of other cannabinoids in the composition, because less than about 0.1% of impurities (which includes any other cannabinoids) is within Applicant’s claimed range of the isolated CBL being about 100% of the total cannabinoids. Even this narrower meaning of “substantially free of impurities”/ other cannabinoids, supports a range of less than about 10% of impurities/ other cannabinoids. Either way, whether other cannabinoids are present or not, this disclosure too supports a composition, according to Applicant’s independent claims, comprising: “a Cannabis plant-isolated cannabidiol, cannabidiol isomer, or cannabidiol analog having a concentration of about 1% (w/w) to about 30% (w/w), relative to the total weight of the composition, wherein the isolated cannabidiol, cannabidiol isomer, or cannabidiol analog is present in an amount of about 80% (w/w) to about 100% (w/w) of the total cannabinoids in the composition.
Sinai discloses a composition comprising a therapeutically effective amount of Cannabidiol (CBD) or a derivative thereof, for use in relieving a subject suffering from fibromyalgia syndrome symptoms, wherein the concentration of said CBD is in the range of about 2% to about 85%. (claim 88 and 89). The composition is administered in a manner selected from the group consisting of: intranasal, transdermal, intradermal, topical, intravenous, oral, and any combination thereof, in combination with at least one therapeutic agent selected from the group comprising of quercetin (Applicant’s claimed P-glycoprotein bioenhancer), gabapentin, paracetamol, tramadol, codeine (further analgesic agents, according to Applicant’s claims 9 and 18), and formulated in a dosage form selected from oil (i.e. lipid-based). (claim 92, [0030], [0032]). The composition additionally comprises at least one carrier or excipient selected from the group consisting of diluents, antiadherents, binders, coatings, disintegrants, surfactants, dissolving agents, solubilising agents in a dosage form selected from topical, cream, gel, etc. (claim 94). Sinai discloses formulating the composition as liposomes. ([0039]).
Sinai discloses that the term “cannabidiol (CBD)” refers hereinafter to one of at least 85 active cannabinoids identified in cannabis, and that cannabidiol is a major phytocannabinoid, accounting for up to 40% of the plant's extract. ([0115]). Other cannabinoids include, e.g. THC. ([0136]). Sinai discloses wherein the concentration of CBD in the composition is from about 2% to about 85%. ([0023]).
Accordingly, it would have been obvious to a person of skill in the art before the effective filing date of the claimed invention to combine the teachings of Stinchcomb and Sinai in order to practice Applicant’s claimed invention with a reasonable expectation of success. The skilled artisan would have been motivated to do so since Stinchcomb specifically discloses a composition according to Applicant’s claims and further discloses a very wide array of bioenhancers as suitable for use in it. Further motivation to do so is found in view of Sinai, which discloses a composition comprising a therapeutically effective amount of Cannabidiol for topical administration, and quercetin is an additional therapeutic agent, and further provides that the combination with such a therapeutic agent provides a synergistic effect.
Other cumulative art also exists concerning Applicant’s elected bioenhancer quercetin of dependent claims 26 and 37. The art is cumulative, because the Examiner already addressed quercetin with Sinai, which is relevant to claims 26 and 37, and lipid-based systems as bioenhancers, which is relevant to claim 38, from which the instant amendments deleted quercetin lipid-based systems, but for which Stinchcomb still continually provides support for lipid-based systems, as also addressed above.
Changoer teaches a cosmetic composition for topical application comprising hemp oil or cannabis oil containing about 1-10% of cannabidiol (CBD), 3-24% of cannabigerol (CBG) which is cannabinoids analogue, at least one anti-oxidant, at least one antiseptics including anti-microbial agent, anti-inflammatory agent, preservative, at least one emulsifier, suitable cosmetic additives and carriers, and de-ionized water. The composition is said to be used as acne treatment cream or tonic, or anti-rash cream and its administration, and the anti-aging cream can be applied to skin to reduce signs of aging including sagging skin, discoloration, dryness, and crow’s feet (=fine lines and wrinkles). Changoer further discloses that cannabinoids are also available in synthetic form, with the synthetic compound usually coming isolated without other cannabinoids mixed in. ([0009)].
Per Changoer, the word “cannabinoid” is used to mean any compound that interacts with a cannabinoid receptor and other cannabinoid mimetics, including, but not limited to, their salts. ([0036)].
Changoer further discloses: “A topical composition for dermal application comprising: hemp oil containing cannabigerol at about 3 to 24 by weight percent and cannabidiol at about 1 to 10 by weight percent; at least one anti-oxidant selected from the group consisting of . . . quercetins. . . at least one anti-inflammatory agent . . . at least one emulsifier; suitable cosmetic additives and carriers; and de-ionized water.”
Changoer further discloses that “topical” dermal compositions used on the skin during daylight should have ultraviolet (UV) ray protection properties to protect the dermis from sun damage. . . CBG has neuro-protective properties as well as anti-oxidant properties, which may be useful is prevention of photodamage of the skin from UV rays exposures.” ([0043]).
Per Applicant’s specification, treating dermatological diseases according to the invention include sunburn. ([0083]).
Accordingly, it would have been obvious to a person of skill in the art before the effective filing date of the claimed invention to combine the teachings of Stinchcomb and Changoer in order to practice Applicant’s claimed invention with a reasonable expectation of success. The skilled artisan would have been motivated to do so since Stinchcomb specifically discloses a composition according to Applicant’s claims and further discloses a very wide array of bioenhancers as suitable for use in it. Further motivation to do so is found in view of Changoer, which discloses a topical composition for dermal application comprising hemp oil containing cannabigerol at about 3 to 24 by weight percent and cannabidiol at about 1 to 10 by weight percent, and at least one anti-oxidant selected from the group consisting of quercetins.
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 21, 22 and 25-31 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) does/do not fall within at least one of the four categories of patent eligible subject matter because the claimed invention is directed to a composition of products of nature without significantly more.
An invention is patent-eligible if it claims a “new and useful process, machine, manufacture, or composition of matter.” 35 U.S.C. § 101. However, the U.S. Supreme Court has interpreted 35 U.S.C. § 101 to include implicit exceptions: “[l]aws of nature, natural phenomena, and abstract ideas” are not patent-eligible. See, e.g., Alice Corp. v. CLS Bank Int’l, 573 U.S. 208, 216 (2014).
In determining whether a claim falls within an excluded category, we are guided by the Court’s two-part framework, described in Mayo and Alice. Id. at 217–18 (citing Mayo Collaborative Servs. v. Prometheus Labs., Inc., 566 U.S. 66, 75–77 (2012)). In accordance with that framework, we first determine to what concept the claim is “directed.” See Alice, 573 U.S. at 219 (“On their face, the claims before us are drawn to the concept of intermediated settlement, i.e., the use of a third party to mitigate settlement risk.”); see also Bilski v. Kappos, 561 U.S. 593, 611 (2010) (“Claims 1 and 4 in petitioners’ application explain the basic concept of hedging, or protecting against risk.”).
If the claim is “directed to” an abstract idea or law of nature or natural phenomenon, we turn to the next step of the Alice and Mayo framework, where “we must examine the elements of the claim to determine whether it contains an ‘inventive concept’ sufficient to ‘transform’ the claimed abstract idea [or law of nature or natural phenomenon] into a patent-eligible application.” Alice, 573 U.S. at 221 (internal quotation marks omitted). For example, “[a] claim that recites an abstract idea must include ‘additional features’ to ensure ‘that the [claim] is more than a drafting effort designed to monopolize the [patent-ineligible concept].’” Id. (alterations in original) (quoting Mayo, 566 U.S. at 77).
In January 2019, the U.S. Patent and Trademark Office (USPTO) published revised guidance on the application of § 101. See 2019 Revised Patent Subject Matter Eligibility Guidance, 84 Fed. Reg. 50 (Jan. 7, 2019) (“Revised Guidance”). The Office issued further guidance on October 17, 2019, clarifying the Revised Guidance. USPTO, October 2019 Update: Subject Matter Eligibility (the “October 2019 Update”) (available at https://www.uspto.gov/sites/default/files/documents/peg_oct_2019_update.pdf). All USPTO personnel are, as a matter of internal agency management, expected to follow the guidance.” Id. at 51; see also October 2019 Update at 1. Under the Revised Guidance and the October 2019 Update, (as “Step 2A”) we first look to whether the claim recites:
(1) any judicial exceptions, including certain groupings of abstract ideas (i.e., mathematical concepts, certain methods of organizing human activity such as a fundamental economic practice, or mental processes) (“Step 2A, Prong One”); and
(2) additional elements that integrate the judicial exception into a practical application (see MPEP §§ 2106.05(a)–(c), (e)–(h) (9th ed. Rev. 08.2017, Jan. 2018)) (“Step 2A, Prong Two”).
Revised Guidance, 84 Fed. Reg. at 52–55.
This includes (a) identifying whether there are any additional elements recited in the claim beyond the judicial exception, and (b) evaluating those additional elements individually and in combination to determine whether the claim as a whole integrates the exception into a practical application. See Revised Guidance — Section III(A)(2), 84 Fed. Reg. at 54–55.
Only if a claim (1) recites a judicial exception and (2) does not integrate that exception into a practical application, do we then look, under Step 2B, to whether the claim:
(3) adds a specific limitation beyond the judicial exception that is not “well-understood, routine, conventional” in the field (see MPEP § 2106.05(d)); or
(4) simply appends well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception.
Revised Guidance, 84 Fed. Reg. at 52–56.
With these standards in mind, the Examiner addresses the application
Claim 21 is directed to a composition comprising:
a Cannabis plant-isolated cannabidiol, cannabidiol isomer, or cannabidiol analog having a concentration of about 1% (w/w) to about 30% (w/w), relative to the total weight of the composition, wherein the isolated cannabidiol, cannabidiol isomer, or cannabidiol analog is present in an amount of about 80% (w/w) to about 100% (w/w) of the total cannabinoids in the composition;
a bioenhancer having a concentration of about 0.05% (w/w) to about 20% (w/w), relative to the total weight of the composition;
and
a pharmaceutically acceptable carrier, excipient, diluent, reagent, or combination thereof.
First, the composition comprises a Cannabis plant-isolated cannabidiol, cannabidiol isomer, or cannabidiol analog, i.e. a natural product. Second, the composition comprises a bioenhancer, which is claimed in the dependent claims to be various natural products, i.e., as non-limiting examples, piperine, quercetin, naringin, aloe vera, lipid-based systems, lecithin, etc. Third, the composition comprises a pharmaceutically acceptable carrier, excipient, diluent, reagent, or combination thereof, which too is defined in the specification as various natural products, i.e. diluents (i.e. this could be as simple as water), sweeteners (i.e. this could be as simple as sugar) and pigments, etc.. ([0081]). Dependent claims recite further natural ingredients, i.e. a humectant, which is lecithin (claim 28), one or more fragrances, dyes, proteins (claim 29).
Further, the recitation of a specific percent range of the Cannabis plant-isolated cannabidiol, cannabidiol isomer, or cannabidiol analog and of the bioenhancer does not add a “marked” change in characteristics of the Cannabis plant-isolated cannabidiol, cannabidiol isomer, or cannabidiol analog and of the bioenhancer found in nature, because the additional presence of a pharmaceutically acceptable carrier, excipient, diluent, reagent, or combination thereof does not change the structure, function, or other properties of the Cannabis plant-isolated cannabidiol, cannabidiol isomer, or cannabidiol analog and of the bioenhancer in any marked way. The Cannabis plant-isolated cannabidiol, cannabidiol isomer, or cannabidiol analog and of the bioenhancer retain their naturally occurring structure and properties (e.g. anti-inflammatory effects, and penetration enhancement, respectively) is in the claimed formulation with a pharmaceutically acceptable carrier, excipient, diluent, reagent, or combination thereof which also retains its naturally occurring structure and properties (e.g., solubility). There are no other exceptions in the claim, which add significantly more.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 21, 22 and 25-31 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 3-10 of copending Application No. 18/317,487 (reference application), and further in view of US 2018/0116998 A1 to Sinai et al. (“Sinai”, of record). Although the claims at issue are not identical, they are not patentably distinct from each other because they disclose overlapping subject matter, i.e. a composition comprising overlapping amounts of CBD, CBD isomer, or CBD analog, and bioenhancer, in overlapping amounts. To the extent that the composition of the reference application is amended to recite that it is “oral”, and that in the instant application to recite “topical”, this is a limitation in the pre-amble, which is not given any patentable weight.
Moreover, both oral and topical compositions of CBD, to include with Applicant’s claimed bioenhancer quercetin (which Stinchcomb does not disclose per se) and with other active agents, are further disclosed in Sinai.
Sinai discloses a composition comprising a therapeutically effective amount of Cannabidiol (CBD) or a derivative thereof, for use in relieving a subject suffering from fibromyalgia syndrome symptoms, wherein the concentration of said CBD is in the range of about 2% to about 85%. (claim 88 and 89). The composition is administered in a manner selected from the group consisting of: intranasal, transdermal, intradermal, topical, intravenous, oral, and any combination thereof, in combination with at least one therapeutic agent selected from the group comprising of quercetin (Applicant’s claimed P-glycoprotein bioenhancer), gabapentin, paracetamol, tramadol, codeine (further analgesic agents, according to Applicant’s claims 9 and 18), and formulated in a dosage form selected from oil (i.e. lipid-based). (claim 92, [0030], [0032]). The composition additionally comprises at least one carrier or excipient selected from the group consisting of diluents, antiadherents, binders, coatings, disintegrants, surfactants, dissolving agents, solubilising agents in a dosage form selected from topical, cream, gel, etc. (claim 94). Sinai discloses formulating the composition as liposomes. ([0039]).
Accordingly, it would have been obvious to a person of skill in the art before the effective filing date of the claimed invention to combine the teachings of the co-pending application with Sinai, in order to practice Applicant’s claimed invention with a reasonable expectation of success. The skilled artisan would have been motivated to do so because Sinai discloses both oral and topical compositions of CBD alike, formulated with a bioenhancer such as quercetin.
Other relevant art
The Examiner also restates for the record the following cumulative prior art:
-US 20150359755- para [0047-53], [0071]
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/SVETLANA M IVANOVA/Primary Examiner, Art Unit 1627