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 .
Examiners Comment
The Examiner assigned to this case has changed. Please note the Examiner’s contact information at the close of this Office action.
Election/Restrictions
Applicant's election with traverse of Group I, in the reply filed on June 9, 2026, is acknowledged. The traversal is on the ground(s) that all claims were searched according to the international search report and written opinion and is not burdensome. This is not found persuasive because for the reasons of record, the claims lack unity in view because the shared technical feature among the groups is not a special technical feature as it does not make a contribution over the prior art as it is taught by Renwick (US 20180085308 A1). The requirement is still deemed proper and is therefore made FINAL.
Claims 1-2, 4, 6, 8-11, 13-18, 20, 22-25, and 28 are pending or which claims 22-25, and 28 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Pending claims 1-2, 4, 6, 8-11, 13-18, and 20 have been examined on the merits.
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, 11, 13-14, 18, 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.
Claims 9 and 13 contain the trademark/trade names, respectively: Solutol HS15® and Tween®, Solutol HS15®Cremophore® (and the EL, ELP, RH40 variant products thereof), Myrl®, Span®, 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 (e.g. “compositions sold under the tradename”), 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 parenthetically to identify/describe some composition or source of the adjacent non-parenthetical expression and, accordingly, the identification/description is indefinite. It is suggested to recite the generic terms in the claims (and cancel the tradenames in the claims).
Claims 11 and 18 are unclear because the terms do not set forth the minimal structure required of the term and the broad or absent functions, i.e. the term “agent” modified by the terms/phrasing: effervescent, combination of, further active and the broad terms “flavour” and “sensate” are unclear as to what materials, if any, are included or excluded by the claims and as such one would not be apprised as to the metes and bounds of, and what applicant in intending by, the claims. Appropriate correction is required.
Claim 20 is unclear because the claim recites the composition is a solid, powder, granule, or particulate form; however, renders the claims unclear what form(s) is/are intended because claim 1, from which the claim depends, recites the composition is in a solution or solubilized form. For clarity of the record it is also noted that additional claims depending from claim 1 (not depending from claim 20) recite the functional term “surfactant”, which absent the specific surfactant-forming materials (such as enumerated in claim 13) is understood the composition requiring a form in which a liquid-liquid or liquid-solid interface is present (though instantly not expressly recited as such). Clarification is required.
All other claims depend directly or indirectly from the rejected claims and are, therefore, also rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, for the reasons set forth above.
Claim Rejections - 35 USC § 102/103
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 –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
(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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
The following is a quotation of 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims under 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of 35 U.S.C. 103(c) and potential 35 U.S.C. 102(e), (f) or (g) prior art under 35 U.S.C. 103(a).
Claims 1, 2, 4, 6, 8-11, 13-18, and 20 are rejected under 35 U.S.C. 102(a)(1) and/or (a)(2)) as anticipated by or, in the alternative, under 35 U.S.C. 103(a) as obvious over Renwick et al (US 2018/0085308 A1; IDS).
The instant claims are drawn to a composition comprising (i) a cannabis compound comprising a constituent, derivative, or extract thereof, and (ii) a lipophilic solvent.
Renwick et al ‘308, however, teaches cannabis comprising compositions, containing in a dosage form in the form of a powder/granule or tablet, and which may be emulsified (self-emulsifying, water-solublized/-dissolution or delayed-release-capable forms)(see ‘308 e.g. at [0061-0064](see instant claims 1+, esp. claims 1,20). The composition may comprise cannabinoid extracts, including thereamong THC and/or CBD (‘308 at [0065-0066]; one or more constituent, derivative, or extract as in instant claims 1,2,4); and may further contain sesame oil (lipophilic solvent; see e.g. [0101]; ), HPMC and hydrophilic polymers (water soluble material; see instant claim 8,9,17, to control drug release and erosion [0041]; surfactants and emulsifiers, including lecithin and/or PEG-6 caprylic/capric glycerides (sold under the tradename Labrasol) [0088, 0092]; see instant claims 11,13).
The cited reference discloses a composition comprising cannabis extract/components, carrier materials, and lipophilic solvent (oils), which appear to be identical to the presently claimed composition since it was produced by the same or similar components materially as instantly claimed. Consequently, the claimed composition appears to be anticipated by the reference.
In the alternative, even if the composition (with respect to amounts and proportions or substitution among similar components (e.g. among surfactants, emulsifiers, identification of the criticality of providing, or the agents providing flavourant, senstate, or active agency, to the orally-administrable compositions, and selection of dissolution/release/delay profile intrinsic to the components) is not identical to the referenced composition, with regard to some unidentified characteristics, the differences between that which is claimed and that which is disclosed, is so slight that the referenced composition is likely to inherently possess the same characteristics of the claimed composition, particularly in view of the similar characteristics which they have been shown to share (e.g. contain the same materials and remains inclusive of the prior art compositions). Thus, the claimed composition would have been obvious to those of ordinary skill in the art within the meaning of 35 USC § 103(a).
Accordingly, the claimed invention as a whole was at least prima facie obvious, if not anticipated by the reference, especially in the absence of sufficient, clear, and convincing evidence to the contrary.
Please note, since the Office does not have the facilities for examining and comparing Applicants’ composition with the composition of the prior art, the burden is on applicant to show a novel or unobvious difference between the claimed product and the product of the prior art. See In re Best, 562 F.2d 1252, 195 USPQ 430 (CCPA 1977) and In re Fitzgerald, 619 F.2d 67, 205 USPQ 594 (CCPA 1980), and “as a practical matter, the Patent Office is not equipped to manufacture products by the myriad of processes put before it and then obtain prior art products and make physical comparisons therewith.” In re Brown, 459 F.2d 531, 535, 173 USPQ 685, 688 (CCPA 1972).
Conclusion
No claims are presently allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AARON J KOSAR whose telephone number is (571)270-3054. The examiner can normally be reached Mon.-Fri. 9-6 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anand Desai can be reached at (571)272-0947. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/AARON J KOSAR/
Primary Examiner, Art Unit 1655
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