DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Election/Restriction
Applicant's election with traverse of Group I, claims 1-3, 5-6, 8-9, 11-12, 14-15, 17, 20, 22, and 24, in the reply filed on 7/28/2026 is acknowledged. The traversal is on the grounds that “there is no undue burden to examine all of the claims” because “the Examiner in the international PCT application examined all of the claims” and “the claims of Groups II and III dependent either directly or indirectly upon independent claim 1”. This is not found persuasive because the actions of the Examiner in the international PCT application are not dispositive in a national stage application (the Office “may cause the question of unity of invention to be reexamined”, 35 U.S.C. 372(b)(2)). Further, undue/serious burden is a test under U.S. restriction practice under 37 CFR 1.141-1.146 for applications filed under 35 U.S.C. 111(a). This test is not applicable to the present Application, which is a National Stage Application submitted under 35 U.S.C. 371 that is instead subject to Unity of Invention practice under 37 CFR 1.499 (see MPEP § 1896(III)). As previously indicated in the requirement for restriction, Groups I, II and III lack unity of invention because the shared technical feature is not a special technical feature, as it does not make a contribution over the prior art.
The requirement is still deemed proper and is therefore made FINAL.
Claims 26-27, 29, and 32-33 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to nonelected inventions, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 7/28/2026.
Status of the Claims
Claims 1-3, 5-6, 8-9, 11-12, 14-15, 17, 20, 22, 24, 26-27, 29, and 32-33 are pending. Claims 26-27, 29, and 32-33 are withdrawn. Claims 2-3, 5-6, 8-9, 11-12, 14-15, 17, 20, 22, 24, 26-27, 29, and 32 have been amended.
Specification
The use of the terms Solutol HS 15®, Tween®, Cremophor® EL, ELP, RH 40, Myrj®, Span®, Brij®, Nonoxynol®, and Vitashure®, which are trade names or marks used in commerce, has been noted in this application. The terms should be accompanied by the generic terminology; furthermore the terms should be capitalized wherever they appear or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
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 9 rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 9, 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). For the purpose of this Office action, “polysaccharides, such as cellulose, starch and their derivatives” in lines 3-4 is interpreted as “polysaccharides” and “polymers and copolymers, such as cellulosics” in line 4 is interpreted as “polymers and copolymers”.
Claim 14 is indefinite due to its dependence from claim 9.
Regarding claim 12, 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). For the purpose of this Office action, “polysaccharides, such as cellulose, starch and their derivatives” in line 4 is interpreted as “polysaccharides” and “polymers and copolymers, such as cellulosics” in line 5 is interpreted as “polymers and copolymers”.
Regarding claim 17, the examples listed within the parentheticals listed below render the claim indefinite because it is unclear whether the limitation(s) within the parentheticals are part of the claimed invention. See MPEP § 2173.05(d). For the purpose of this Office action:
“polyoxyethylene sorbitan fatty acid esters (Polysorbate, Tween®)” in lines 4-5 is interpreted as “polyoxyethylene sorbitan fatty acid esters”;
“polyoxyethylene castor oil derivatives (Cremophor® EL, ELP, RH 40)” in line 6 is interpreted as “polyoxyethylene castor oil derivatives”;
“polyoxyethylene stearates (Myrj®)” in lines 6-7 is interpreted as “polyoxyethylene stearates”;
“sorbitan fatty acid esters (Span®)” in line 7 is interpreted as “sorbitan fatty acid esters”;
“polyoxyethylene alkyl ethers (Brij®)” in line 7 is interpreted as “polyoxyethylene alkyl ethers”.
Further, claim 17 contains the trademarks/trade names Tween®, Cremophor® EL, ELP, RH 40, Myrj®, Span®, and Brij®. 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, while the trademark/trade name Solutol HS 15® provides an alternate name for a specific identified chemical, polyoxyethylene 15 hydroxy stearate, which is not indefinite, the trademarks/trade names Tween®, Cremophor® EL, ELP, RH 40, Myrj®, Span®, and Brij® are used to identify/describe groups of chemicals and, accordingly, the identification/description is indefinite.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-3, 5-6, 8-9, 12, 14-15, 17, 20, 22, and 24 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Schaneville (US 2019/0240274 A1, provided by applicant on IDS filed 1/18/2024).
Regarding claim 1, Schaneville discloses a composition (“films”, ¶ 0030) comprising one or more constituent, derivative or extract of cannabis in amorphous form (“The active agent being an extracted substance from cannabis or hemp”, ¶ 0009, which may be “in any form . . . . such as an oil or wax extract”, ¶ 0031) and an additive capable of slowing or inhibiting crystallisation of the one or more constituent, derivative or extract of cannabis in an aqueous environment (“Crystallization inhibitors, if present in the film, may be selected from polyvinylpyrollidone”, ¶ 0059).
Regarding claim 2, Schaneville discloses the composition as claimed in claim 1 as stated above. Schaneville further discloses wherein the additive is a polymer (as discussed in the rejection of claim 1, the additive is polyvinylpyrollidone, which is a polymer, “Examples of non-saccharide based, water soluble polymers include . . . polyvinylpyrrolidone”, ¶ 0119).
Regarding claim 3, Schaneville discloses the composition as claimed in claim 1 as stated above. Schaneville further discloses wherein the additive is polyvinylpyrrolidone (“Crystallization inhibitors, if present in the film, may be selected from polyvinylpyrollidone”, ¶ 0059).
Regarding claim 5, Schaneville discloses the composition as claimed in claim 1 as stated above. Schaneville further discloses wherein the constituent, derivative or extract of cannabis is one or more compounds selected from: cannabinoids; terpenes; alkaloids; and flavonoids (“The active agent being an extracted substance from cannabis or hemp, may include cannabinoids”, ¶ 0009).
Regarding claim 6, Schaneville discloses the composition as claimed in claim 1 as stated above. Schaneville further discloses wherein the constituent, derivative or extract of cannabis is tetrahydrocannabinol (THC) (“The active agent being an extracted substance from cannabis or hemp, may include . . . tetrahydrocannabinol (THC)”, ¶ 0009).
Regarding claim 8, Schaneville discloses the composition as claimed in claim 1 as stated above. Schaneville also discloses the composition further comprising a carrier material (“sheet matrix”, ¶ 0128) onto which the amorphous constituent, derivative or extract of cannabis is adsorbed (“the active agent . . . may be included as particles . . . . embedded in a surface” of the sheet matrix, ¶ 0128).
Regarding claim 9, Schaneville discloses the composition as claimed in claim 8 as stated above. Schaneville further discloses wherein the carrier material is water soluble (“a solid water soluble polymeric matrix”, ¶ 0113).
Regarding claim 12, Schaneville discloses the composition as claimed in claim 1 as stated above. Schaneville further discloses wherein the additive is embedded within a water soluble matrix (“The film may further include one or more components in the matrix, such as . . . crystallization inhibitor”, ¶ 0043, emphasis added, where the matrix is “a solid water soluble polymeric matrix”, ¶ 0113).
Regarding claim 14, Schaneville discloses the composition as claimed in claim 9 as stated above. Schaneville further discloses wherein the additive is embedded in the water soluble carrier onto which the amorphous constituent, derivative or extract of cannabis is adsorbed (“The film may further include one or more components in the matrix, such as . . . crystallization inhibitor”, ¶ 0043, emphasis added).
Regarding claim 15, Schaneville discloses the composition as claimed in claim 1 as stated above. Schaneville also discloses the composition further comprising an effervescent agent (“The film may further include one or more components in the matrix such as . . . an effervescent agent”, ¶ 0043).
Regarding claim 17, Schaneville discloses the composition as claimed in claim 1 as stated above. Schaneville also discloses the composition further comprising a surfactant (“The film may further include one or more components in the matrix such as . . . a surfactant”, ¶ 0043).
Regarding claim 20, Schaneville discloses the composition as claimed in claim 1 as stated above. Schaneville further discloses wherein release of the one or more constituent, derivative or extract of cannabis from the compositions begins within a period of 30 seconds following exposure of the composition to water (“The film unit of the present disclosure is at least partially dissolvable when exposed to a wetting agent or may be substantially dissolvable when exposed to a wetting agent. The film of the present disclosure may be absorbed through the mucosal tissue within about 20 seconds . . . . so that the bulk of the active agent seeps through the mucosal tissue of the subject”, ¶ 0122, using “a wetting agent, such as water”, ¶ 0112).
Regarding claim 22, Schaneville discloses the composition as claimed in claim 1 as stated above. Schaneville also discloses the composition comprising a further flavour (“The film may further include one or more components in the matrix such as . . . flavoring agent”, ¶ 0043).
Regarding claim 24, Schaneville discloses the composition as claimed in claim 1 as stated above. Schaneville further discloses that the composition is in the form of a solid unit dosage form (“the film can be cured and solidified”, ¶ 0084, emphasis added, and “Each of the films prepared according to the present disclosure may be divided into smaller individual film units which may be sized and packaged to provide dosage units for consumption”, ¶ 0113, emphasis added).
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.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Schaneville (US 2019/0240274 A1) as applied to claim 8 above.
Regarding claim 11, Schaneville discloses the composition as claimed in claim 8 as stated above. Schaneville does not disclose the weight of the carrier material relative to the weight of the total composition (which includes the carrier material, the constituent, derivative or extract of cannabis and the crystallization inhibitor) in order to determine if it falls within the claimed range. However, Schaneville teaches that the composition is for improved delivery of the constituent, derivative or extract of cannabis (¶ 0008). The efficacy of the composition for this result depends on the weight of the carrier material relative to the weight of the total composition. If the relative weight of the carrier material is too low, there will not be sufficient carrier to hold the constituent, derivative or extract of cannabis and the crystallization inhibitor. If the relative weight of the carrier material is too high, then the dose of the constituent, derivative or extract of cannabis per unit of composition will be too low. Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to optimize the weight of the carrier material relative to the weight of the total composition such that it falls within the claimed range. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." (In re Aller, 105 USPQ 233 (C.C.P.A. 1955); MPEP § 2144.05(II)(A)).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to COURTNEY G CULBERT whose telephone number is (571)270-0874. The examiner can normally be reached Monday-Friday 9am-4pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael H Wilson can be reached at (571)270-3882. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/COURTNEY G CULBERT/Examiner, Art Unit 1747
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