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 .
Response to Arguments
Applicant’s response from 3/5/2025 is acknowledged.
Specification
In view of Applicant’s specification amendments, the objections are hereby withdrawn.
Claim Rejections - 35 USC § 112
In view of Applicant’s claim amendments, this rejection is hereby withdrawn. However, in view of Applicant’s claim amendments, a new rejection has been made below.
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.
Double patenting
Applicant has not addressed the rejection, in view of which it is maintained.
Claims 1-11, 13 and 15-21 are pending, and have been examined herewith.
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 2 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 1, as amended, recites the following limitation with respect to the cannabinoids and their total amounts: “a Cannabis plant-isolated cannabidiol, cannabidiol isomer, or cannabidiol analog, having a concentration of about 1% to about 30% relative to the total weight of the composition, wherein the cannabidiol, cannabidiol isomer, or cannabidiol analog is about 80% (w/w) to about 100% (w/w) of cannabinoids in the composition”.
Claim 2 recites the limitation “wherein the composition further comprises a number of other cannabinoids”. This limitation is vague and indefinite and subject to many different interpretations since this claim depends from claim 1, and claim 1 as amended already sets a limit on the total amount of all cannabinoids relative to that of the Cannabis plant-isolated cannabidiol, cannabidiol isomer, or cannabidiol analog.
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 1-6, 8-11, 13 and 15-19 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over US 20100273895 to Stinchcomb et al. (“Stinchcomb”), and further in view of US 2018/0116998 A1 to Sinai et al. (“Sinai”, of record).
Claim interpretation
With respect to Applicant’s composition claims 1-10, it is noted that to the extent that the composition of the instant application is amended to recite that it is “oral”, this is a limitation in the pre-amble, which is not given any patentable weight. “[A] claim preamble has the import that the claim as a whole suggests for it.” Bell Communications Research, Inc. v. Vitalink Communications Corp., 55 F.3d 615, 620 (Fed. Cir. 1995). In instances where a patentee uses the claim preamble to recite structural limitations of his claimed invention, the PTO and courts give effect to that usage. Rowe v. Dror, 112 F.3d 473, 478 (Fed. Cir. 1997) (citing Corning Glass Works v. Sumitomo Elec. U.S.A., Inc., 868 F.2d 1251, 1257 (Fed. Cir. 1989). Conversely, where a patentee defines a structurally complete invention in the claim body and uses the preamble only to state a purpose or intended use for the invention, the preamble is not a claim limitation. Id. (citing Bell Communications, 55 F.3d at 620; Kropa v. Robie, 187 F.2d 150 (1951). In the instant case, the limitation “oral” only states a purpose or intended use for the invention and patentee defines a structurally complete invention in the claim body.
Rejection
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 as amended 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). This falls within the scope of Applicant’s claimed bioenhacer “lipid-based systems” of claim 5 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]).
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]). 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]). Although Stinchcomb relates to transdermal delivery methods of administration, it does nonetheless explicitly acknowledge that there are cannabinoid oral dosage forms, including cannabidiol. ([0011]). In fact, Stinchcomb also discloses the benefit of administering by means such as oral, concurrently with the transdermal route. ([0015]).
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 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 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.”
Oral 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]).
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 oral or topical administration, and quercetin is an additional therapeutic agent, and further provides that the combination with such a therapeutic agent provides a synergistic effect. Although Stinchcomb does not disclose the amount of the additional therapeutic agent it would have been obvious to a person of skill in the art before the effective filing date of the claimed invention to optimize the amount of additional therapeutic agent, based on the disclosure of Sinai alone. The skilled artisan would have been motivated to do so since for each agent and specific condition being treated it is always a primary consideration to administer it within optimal therapeutic doses for this agent and condition. Therefore, it is not inventive to discover such amounts by routine experimentation when the general conditions of a claim are disclosed in the prior art. See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) and MPEP §2144.05(11).
Claims 7 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over US 2018/0116998 A1 to Sinai et al. (“Sinai”, of record), and further in view of US 2016/0235661 A1 to Changoer et al. (“Changoer”), as applied to claims 1-6, 8-11, 13 and 15-19, 21 and 22 in the 35 U.S.C. 103 rejection above, and further in view of US 8,758,826 to Bevier (“Bevier”, of record), and Sarwa K.K. et al., Potential of capsaicin-loaded transferosomes in arthritic rats. Drug Deliv. 2014; 22: 638–646 (“Sarwa”, of record).
Stinchcomb and Sinai are discussed in the 35 U.S.C. 103 rejection above.
Sinai discloses oral and transdermal delivery, but does not specifically disclose by means such as transferosomes (an alternative bioenhancer of Applicant’s claims 7 and 20).
Bevier relates to compositions and methods for topical delivery of cannabinoid receptor binding agents, and related therapeutic uses. (Abstract). Bevier claims a composition comprising a cannabidiol present at about 1% to about 55% by weight of the composition, and a polymeric nanoparticle containing the cannabidiol, wherein the polymeric nanoparticles are present at about 75% or less and greater than 1% by weight of the composition. (claim 6). Claim 13 of Bevier recites the composition of claim 6, further comprising a vesicle to encapsulate the cannabidiol and polymeric nanoparticles to modify a property of the composition, the vesicle selected from the group consisting of liposomes (also disclosed as a suitable delivery vehicle in Sinai), ethosomes, niosomes, and transferosomes.
Bevier further provides: “One may prepare a mixture of such cannabinoid receptor binding agents, selective for particular receptors or portions thereof. Moreover, because some cannabinoids also bind to other receptors, one may select a cannabinoid receptor binding agent that binds one or more non-cannabinoid receptors. These include a vanilloid receptor, including a capsaicin receptor, and an epidermal growth factor receptor.” (col. 6, ll. 21-25).
Bevier does not explicitly disclose that the transferosomes are a particular type of transferosomes, e.g. capsaicin transferomes, colchicine transferosomes, vincristine transferomes, per Applicant’s claims 7 and 20.
Sarwa is a study of to the biopotential of capsaicin (an active principle of capsicum) as a topical antiarthritic agent in transfersomal vesicular system in experimental rats. The study reports that the formulation possesses superior inhibitory activity of the specially designed transfersomal delivery system than the marketed Thermagel formulation at the same dosage level, as well as better tolerance. (Abstract). Per Sarwa: “The traditional uses of capsicum fruits in various musculoskeletal disorders such as toothache, waist pain, muscle pain, have been reported from different parts of the world. Capsaicin, a bioactive principle of capsicum, is well known for its use in modern topical drug delivery system such as cream, intended for administration in several clinical indications like arthritic pain, neuralgia, psoriasis, and pruritis.” (Introduction). It is noted that rheumatoid arthritis is a claimed disease by Applicant, as well as that fibromyalgia is known to one of ordinary skill in the art as a type of arthritis that causes pain.
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, Sinai, Bevier and Sarwa 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 both Stinchcomb and Sinai disclose both oral and topical compositions of CBD, with Sinai further disclosing utility in the treatment of fibromyalgia. The skilled artisan would have been further motivated to do so in view of the teachings of Bevier, which specifically discloses a composition comprising a cannabidiol present at about 1% to about 55% by weight of the composition, and a polymeric nanoparticle containing the cannabidiol, wherein the polymeric nanoparticles are present at about 75% or less and greater than 1% by weight of the composition, further comprising a vesicle to encapsulate the cannabidiol and polymeric nanoparticles to modify a property of the composition, the vesicle selected from the group consisting of liposomes (also disclosed as a suitable delivery vehicle in Sinai), ethosomes, niosomes, and transferosomes. Bevier places no limit on the type of transferosome. But if one were to try and select a particular type of transferosome, further motivation to select e.g. a capsaicin transferosome, is in view of the disclosure in Bevier that cannabinoids bind to the capsaicin receptor, and the disclosure in Sarwa that capsaicin transferosomes have been studied and found to be effective in the treatment of rheumatoid arthritis (a claimed condition by Applicant), and pain associated therewith, and further in view of fibromyalgia too being known to one of ordinary skill in the art as a type of arthritis that causes pain (a further claimed condition by Applicant, as well as one disclosed in Sinai). Moreover, while transfersomes are primarily known for their transdermal drug delivery capabilities, they have also been explored for oral drug delivery due to their overall ability to enhance the bioavailability of poorly water-soluble drugs, which is further motivating factor as well. Thus, multiple lines or reasoning render obvious Applicant’s claimed invention.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-10 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 1 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 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, 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.. ([0059]). Dependent claims recite further agents, i.e. anti-inflammatory agent, antibiotics (claim 8), of which there are many known examples of natural agents.
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 1-10 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 21-23 and 25-31 of copending Application No. 18/317,445 (reference application). 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 instant application is amended to recite that it is “oral”, this is a limitation in the pre-amble, which is not given any patentable weight. “[A] claim preamble has the import that the claim as a whole suggests for it.” Bell Communications Research, Inc. v. Vitalink Communications Corp., 55 F.3d 615, 620 (Fed. Cir. 1995). In instances where a patentee uses the claim preamble to recite structural limitations of his claimed invention, the PTO and courts give effect to that usage. Rowe v. Dror, 112 F.3d 473, 478 (Fed. Cir. 1997) (citing Corning Glass Works v. Sumitomo Elec. U.S.A., Inc., 868 F.2d 1251, 1257 (Fed. Cir. 1989). Conversely, where a patentee defines a structurally complete invention in the claim body and uses the preamble only to state a purpose or intended use for the invention, the preamble is not a claim limitation. Id. (citing Bell Communications, 55 F.3d at 620; Kropa v. Robie, 187 F.2d 150 (1951).
Other relevant art
The Examiner also notes for the record the following cumulative prior art:
-US 20150359755- para [0047-53], [0071]
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SVETLANA M IVANOVA whose telephone number is (571)270-3277. The examiner can normally be reached 8:30-5:00.
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/SVETLANA M IVANOVA/Primary Examiner, Art Unit 1627