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 .
Priority
This application, filed 01/16/2024 is a National Stage entry of PCT/GB2022/051900, International Filing Date: 07/21/2022. PCT/GB2022/051900 Claims Priority from Provisional Application 63224570, filed 07/22/2021.
Status of Claims
Claims 1-5, 7, 10-15, 17, 20-21, 23-25, and 27-28 are pending as of the response filed on 6/5/26. Claims 6, 8-9, 16, 18-19, 22, and 26 have been canceled.
Applicant's election with traverse of invention I, claims 1-5, 7, 10-15, 17, 20-21, 23, and 27; and the species of cannabidiol (CBD) as the constituent of cannabis; and hydroxypropyl methyl cellulose (HPMC) as the crystallization inhibiting additive in the reply filed on 6/5/26 is acknowledged. The traversal in response to the restriction requirement is on the ground(s) that there should be no undue burden in examining all of the claims in the application. This is not found persuasive because the application is a national stage entry of an international application, and the establishment of lack of unity between inventions, rather than examination burden is proper for restriction. As discussed in the previous action, inventions I, II, and III lack unity because the shared technical feature doesn’t make a contribution over the prior art in view of Garti et. al., US 20190314326 A1. As the shared technical feature isn’t novel, unity of invention is lacking.
Applicants have traversed the species election requirement, having argued Garti fails to disclose additives that slow crystallization or a constituent, derivative, or extract of cannabis as claimed, as Garti only mentions solubilizers of cannabis constituents. This argument is not persuasive, as additives that inhibit crystallization include surfactants such as polyoxyethylene castor oil derivatives, sorbitan fatty acid esters, and lecithin, all taught by Garti as components in the composition (see for instance para [0035-0036], [0045]). As discussed in the office action, these surfactants all differ structurally from each other; as such, unity of invention among the species is lacking for at least these reasons as well as those discussed in the restriction requirement.
The requirement is still deemed proper and is therefore made FINAL.
Claims 24-25 and 28 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 6/5/26.
Claims 1-5, 7, 10-15, 17, 20-21, 23, and 27 were examined and are rejected.
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.
Claims 4-5, 7, and 20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claims 4-5 and 7, 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 7 contains the trademark/trade names Tween, Solutol, Cremophor, Myrj, Span, Brij, and Nonxynol. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe the products and, accordingly, the identification/description is indefinite.
Claim 20 recites the composition “in the form of a solid unit dosage form”, followed by “a powder or granules”. This language renders the claim indefinite, because “a solid unit dosage form” is considerably broader than “a powder or granules”, and it is uncertain if the composition can be in any solid unit dosage form or is limited to a powder or granule dosage form. For compact prosecution, this claim was given the broader interpretation.
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.
Claim(s) 1-4, 11-13, and 15 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Archibald, US 20190254988 A1, publ. 8/22/2019.
Although a species election was made to HPMC as the crystallization inhibitor additive, this rejection is made over the broad scope of the claim to provide compact prosecution.
Archibald discloses non-crystalline cannabidiol compositions, wherein the concentration of cannabidiol (CBD) is 30% w/w or greater, further comprising at least one terpene alcohol (title & abstract). Archibald discloses cannabinoids such as CBD have medicinal and psychoactive properties making them of great interest, however, their bioavailability is increased when they are administered in non-crystalline form (para [0002], [0004]). Archibald discloses the incorporation of a terpene alcohol in the compositions comprising CBD inhibits crystallization due to hydrogen bonding disruption (para [0003]). Archibald discloses compositions comprising 30% w/w CBD, alpha-bisabolol as a terpene alcohol, and limonene as a diluent, i.e. solvent (para [0069]; para [0070], see Tables 1, 2, & 3), wherein the crystallization scores for the compositions measured at days 7, 14, and 27 were 0 (para [0071] and Tables 5-7). Limonene is well-known in the art as an oil. Archibald therefore anticipates the claims.
Regarding instant claim 13, wherein the composition has enhanced bioavailability properties in the gastric system, Archibald discloses a composition that has the same components as required by the claims. Therefore, the composition would have necessarily had this characteristic. See MPEP 2112.01(II): "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). 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.
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.
Claim(s) 5, 10, 17, and 20-21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Archibald, US 20190254988 A1, as applied to claims 1-4, 11-13, and 15 as discussed previously, in view of Schaneville, US 20170290870 A1, publ. 10/12/2017.
The disclosure of Archibald as discussed previously is incorporated herein. Additionally, Archibald teaches the composition can further include an additional active such as a dopamine reuptake inhibitor, a dopamine releasing agent, an opioid receptor agonist, an antidepressant, an NMDA antagonist, or a 5-HT2 receptor agonist (para [0016]). In addition to a viscous liquid, i.e., a solution, Archibald teaches the composition in the form of a wax, a tincture, a pill, tablet, a suppository, or microencapsulated powder (para [0018-0019]). Archibald teaches additional carriers for the composition to include povidone, also known in the art as polyvinylpyrrolidone (para [0021]), as well as a disintegrant to aid in tablet dispersion (para [0043]). As tablets are taught as suitable dosage forms, it would have been prima facie obvious that the tablet would have been water dispersible, as recited by instant claim 21, e.g., upon oral ingestion.
Archibald doesn’t explicitly teach the elected crystallization inhibitor, HPMC.
Schaneville teaches film compositions comprising a matrix and one or more active agents from hemp or cannabis within the matrix (title & abstract). Schaneville teaches the compositions can further comprise crystallization inhibitors, with HPMC exemplified as such an inhibitor (para [0038], [0054]).
It would have been prima facie obvious to one of ordinary skill in the art, before the effective filing date of the claims to have incorporated the elected species, HPMC, as a crystallization inhibitor additive into the composition of Archibald, in consideration of Schaneville’s teaching and exemplification of HPMC as a crystallization inhibitor. Archibald and Schaneville both teach compositions comprising cannabis components as active agents, while Archibald teaches the inclusion of a crystallization inhibitor, a terpene alcohol, to improve bioavailability. As Schaneville teaches HPMC also as a crystallization inhibitor, it would have been prima facie obvious to have incorporated HPMC as a crystallization inhibitor, with the reasonable expectation that bioavailability of CBD would have been similarly improved. See MPEP 2144.06(II): An express suggestion to substitute one equivalent component or process for another is not necessary to render such substitution obvious. In re Fout, 675 F.2d 297, 213 USPQ 532 (CCPA 1982).
Claim(s) 7, 14, 23, and 27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Archibald, US 20190254988 A1, as applied to claims 1-4, 11-13, and 15 as discussed previously, and further in view of Heller, WO 2018204326 A1, publ. 11/8/2018.
The disclosure of Archibald as discussed previously is incorporated herein. However, Archibald doesn’t teach or suggest encapsulation by a micelle comprising a surfactant; wherein the composition further comprises a component that enhance intestinal absorption; or wherein the composition is a colloidal dispersion.
Heller teaches compositions comprising particulate material derived from a cannabis plant, comprising a cannabinoid and a terpene, as well as a polymeric mixture that encapsulates the cannabinoid and terpene (title & abstract; para [0001]). Heller teaches conventional cannabinoid compositions typically have a limited shelf life, contain volatile components, and/or require complex emulsifying agents and processes in order to form a desired product (para [0002]). Heller teaches a composition comprising a cannabinoid and terpene that is self-emulsifying, wherein the cannabinoid is homogeneously dispersed and entrapped within a polymer network; the composition has substantially higher bioavailability compared to a traditional cannabinoid dissolved in an edible oil (para [0003-0005]). A colloidal solution form is taught (para [0009]), and CBD is exemplified as a cannabinoid (para [0011], [0018], [0067]). Heller further teaches the composition to comprise an emulsifier or surfactant for encapsulation, including micelles and liposomes (para [0089]). Heller further teaches the composition as a beverage or other liquid oral dosage form having long term stability (para [00379]).
It would have been prima facie obvious to one of ordinary skill in the art, before the effective filing date of the claims to have incorporated the dosage forms taught by Heller, e.g. a surfactant containing micelle or liposome, into the composition taught by Archibald, for the advantages taught by Heller. Both Archibald and Heller teach CBD compositions, while Heller teaches the inclusion of a polymer and surfactant, such as in micelle or liposome form, to encapsulate a cannabinoid such as CBD and a terpene allowing for enhanced bioavailability. As such, one of ordinary skill in the art would have been motivated to have incorporated a micelle or liposome containing a polymer and surfactant for encapsulating CBD and terpene containing components of the composition taught by Archibald, with the reasonable expectation that bioavailability would have been enhanced.
Regarding instant claim 14, Applicants’ specification defines a liposome as a component that enhances intestinal absorption (p. 16, lines 12-35). Therefore, the teaching of a liposome meets this limitation.
Claim Rejections-Nonstatutory 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 filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual 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/apply/applying-online/eterminal-disclaimer.
Claims 1-5, 10-13, 17, 20-21, and 23 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 4, 6, 8-11, 13, 17-18, 20, and 22 of copending application 18580066. Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are drawn to a composition comprising a constituent, derivative, or extract of cannabis, a lipid or solvent in which the constituent, derivative, or extract of cannabis is at least partially soluble, and an additive that slows or inhibits crystallization of the constituent, derivative, or extract of cannabis. For instance, both sets of claims include CBD as a constituent, derivative, or extract of cannabis (instant claim 11 & copending claim 4); and inhibitors of crystallization that include HPMC (copending claim 17 & instant claims 1 and 10). Additionally, both sets of claims include oils as the lipids (see copending claim 2 & instant claim 3). As such, the instant and copending claims are not patentably distinct.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-5, 7, 10-15, 17, 20-21, 23, and 27 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5, 9, 11, 14, 17, 19-20, 22-23, 28, and 32 of copending application 18580022. Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are drawn to a composition comprising a constituent, derivative, or extract of cannabis, a lipid or solvent in which the constituent, derivative, or extract of cannabis is at least partially soluble, and an additive that slows or inhibits crystallization of the constituent, derivative, or extract of cannabis. For instance, both sets of claims include CBD as a constituent, derivative, or extract of cannabis (instant claim 11 & copending claim 3); and inhibitors of crystallization that include PVP (copending claim 17 & instant claims 1 and 10). Additionally, both sets of claims encompass encapsulation within a micelle containing a surfactant (copending claim 11 & instant claim 5); a component for enhancing enterocyte intestinal absorption (copending claim 19 & instant claim 14); a component for increasing intestinal lymphatic transport (copending claim 20 & instant claim 15); and wherein the composition is in the form of a beverage (copending claim 32 & instant claim 27). As such, the instant and copending claims are not patentably distinct.
Claims 1-5, 10-13, 17, 20-21, and 23 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 5, 7-8, 10, 15-16, 18 and 26-28 of copending application 18579985. Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are drawn to a composition comprising a constituent, derivative, or extract of cannabis, a lipid or solvent in which the constituent, derivative, or extract of cannabis is at least partially soluble, and an additive that slows or inhibits crystallization of the constituent, derivative, or extract of cannabis. For instance, both sets of claims include CBD as a constituent, derivative, or extract of cannabis (instant claim 11 & copending claim 5); and inhibitors of crystallization that include HPMC (copending claim 15 & instant claims 1 and 10). Additionally, both sets of claims include a solvent in which the cannabis constituent is at least partially soluble (copending claim 28). As such, the instant and copending claims are not patentably distinct.
Claims 1-5, 7, 10-15, 17, 20-21, 23, and 27 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3-5, 7-8, 10, 13, 16, 18-19, 21-23, 25, 28, and 32 of copending application 18580005. Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are drawn to a composition comprising a constituent, derivative, or extract of cannabis, a lipid or solvent in which the constituent, derivative, or extract of cannabis is at least partially soluble, and an additive that slows or inhibits crystallization of the constituent, derivative, or extract of cannabis. For instance, both sets of claims include CBD as a constituent, derivative, or extract of cannabis (instant claim 11 & copending claim 5); inhibitors of crystallization that include PVP (copending claim 16 & instant claims 1 and 10); and a second active agent (copending claim 1 & instant claim 17). Additionally, both sets of claims encompass encapsulation within a micelle containing a surfactant (copending claim 10 & instant claim 5); a component for enhancing enterocyte intestinal absorption (copending claim 18 & instant claim 14); a component for increasing intestinal lymphatic transport (copending claim 19 & instant claim 15); and wherein the composition is in the form of a beverage (copending claim 32 & instant claim 27). As such, the instant and copending claims are not patentably distinct.
Claims 1-5, 10-13, 17, 20-21, and 23 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, 6, 8, 12, 16-17, 19, 23, 28, and 32 of copending application 18579797. Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are drawn to a composition comprising a constituent, derivative, or extract of cannabis, a lipid or solvent in which the constituent, derivative, or extract of cannabis is at least partially soluble, and an additive that slows or inhibits crystallization of the constituent, derivative, or extract of cannabis. For instance, both sets of claims include CBD as a constituent, derivative, or extract of cannabis (instant claim 11 & copending claim 4); inhibitors of crystallization that include PVP and HPMC (copending claim 17 & instant claims 1 and 10). Additionally, both sets of claims encompass encapsulation within a micelle containing a surfactant (copending claim 19 & instant claim 5). As such, the instant and copending claims are not patentably distinct.
Claims 1-5, 7, 10-15, 17, 20-21, 23, and 27 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 5, 8-13, 18-21, and 25 of copending application 18580411. Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are drawn to a composition comprising a constituent, derivative, or extract of cannabis, a lipid or solvent in which the constituent, derivative, or extract of cannabis is at least partially soluble, and an additive that slows or inhibits crystallization of the constituent, derivative, or extract of cannabis. For instance, both sets of claims include CBD as a constituent, derivative, or extract of cannabis (instant claim 11 & copending claim 9); inhibitors of crystallization that include PVP (copending claim 8 & instant claims 1 and 10); and a second active agent (copending claim 15 & instant claim 17). Additionally, both sets of claims encompass encapsulation within a micelle containing a surfactant (copending claim 5 & instant claim 5); a component for enhancing enterocyte intestinal absorption (copending claim 12 & instant claim 14); a component for increasing intestinal lymphatic transport (copending claim 13 & instant claim 15); and wherein the composition is in the form of a beverage (copending claim 25 & instant claim 27). As such, the instant and copending claims are not patentably distinct.
Claims 1-5, 10-13, 17, 20-21, and 23 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 5-6, 17, 22, 24, and 26 of copending application 18580361. Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are drawn to a composition comprising a constituent, derivative, or extract of cannabis, a lipid or solvent in which the constituent, derivative, or extract of cannabis is at least partially soluble, and an additive that slows or inhibits crystallization of the constituent, derivative, or extract of cannabis. For instance, both sets of claims include CBD as a constituent, derivative, or extract of cannabis (instant claim 11 & copending claim 6); and inhibitors of crystallization that include HPMC (copending claim 3 & instant claims 1 and 10). Additionally, both sets of claims include a solvent in which the cannabis constituent is at least partially soluble (copending claim 2). As such, the instant and copending claims are not patentably distinct.
Information Disclosure Statements
The IDS filed on 1/16/24 and 11/13/25 have been considered.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARAH PIHONAK whose telephone number is (571)270-7710. The examiner can normally be reached Monday-Friday 9:00-5:30 EST.
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SARAH . PIHONAK
Primary Examiner
Art Unit 1627
/SARAH PIHONAK/Primary Examiner, Art Unit 1627
Prosecution Insights