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 .
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.
Current Status of 18/728,964
This Office Action is responsive to the amended claims of 15 July 2024.
Currently amended claims 1-9, 11-14, 16, and 18-23 have been examined on the merits.
Priority
The effective filing date is 14 January 2022.
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 15 July 2024, is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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.
Claim 18 is rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. Claim 18 is drawn to “Use of” which is a “use” claim. Use claims are non-statutory in nature. The claim(s) does/do not fall within at least one of the four categories of patent eligible subject matter because “use” claims are not compositions-of-matter, process, machine, or manufactures.
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 18-22 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.
Claim 18 recites the limitation "spray dried product obtained with the method according to claim 1". There is insufficient antecedent basis for this limitation in the claim.
This limitation renders the metes and bounds of claim 18 undefined (hence rendering claim 18 indefinite under 35 USC 112(b)) since the artisan does not know where antecedent basis can be found for “spray dried product” within claim 1. The same issue occurs in claims 19-20 and 22, which is similarly rejected as indefinite under 35 USC 112(b). Similarly, there is no antecedent basis to “Second liquid” within claim 21, which is rejected under 35 USC 112(b) indefiniteness.
Claim 18 is a “use” claim. The “use” limitation renders the metes and bounds of the claim undefined (hence rendering claim 18 indefinite under 35 USC 112(b)) since the artisan does not know if the “use” claim is intended as a method claim. The “use” makes claim 18 indefinite since there are missing steps (steps must be written in active /gerund “-ing” ending) verbs. Please revise to a method claim with active steps to render moot this rejection.
Conclusion
Claims 18-22 are not presently allowable as written.
Claims 1-9, 11-14, 16, and 23 are presently allowable as written.
There is no known prior art references that either teaches or anticipates a method according to instant claims 1 and 23.
The order of steps of instant claims 1 and 23 are specific to the instant invention and thus are novel and non-obvious.
Instant claims 1 and 23 define a method of producing a CBD-containing liquid. These methods recite preparation of said liquid from water, oil, and CBD and an emulsifier using a high shear mixture (“ultra turrax”) and subjecting this mix to a pressure of at least 250 bar.
The reference FRANCKE (Francke, Nadine Monika et al. “Formulation of Cannabidiol in Colloidal Lipid Carriers.” Molecules. (2021-03-08), 1469, discussed in Written Opinion for PCT/NL2023/050011, referenced in IDS of 15 July 2024), discloses a colloidal lipid emulsions containing CBD (see Chapter 2.2). These emulsions correspond to the first phase defined in instant claim 1 and these emulsions were prepared by subjecting aqueous phase (sodium azide, emulsifier, bidistilled water) and lipophilic phase (CBD being added to oils is described in 2.6-i.e. oil being previously incubated with CBD) to ultra turrax 11,000 RPM, followed by high-pressure homogenization approximately 10 times through the microfluidizer at 300-1500 bar. However, FRANCKE is silent as to the instantly claimed emulsifier and the CBD.
The reference WOELFEL (U.S. 2019/015383 A1, discussed in Written Opinion for PCT/NL2023/050011, referenced in IDS of 15 July 2024), discloses, in example 1, a mixture of canola oil and a cannabinoid subjected together with modified food starch (an emulsifier) and water to emulsification at 5,000 RPM and homogenized twice at 5,000 psi (i.e., 340 bar). The cannabinoid is not defined in said example, but CBD and THC seem to be preferred in further examples of this documents. This seems to correspond to combined first and second of the presently claimed stages, followed by the homogenization. WOELFEL does not describe a first premixing stage to provide a first stage mixture, to which the water is added at the start of the second stage.
The reference FRANCKE 2 (Francke, Nadine Monika et al. “Formulation of Cannabidiol in Lipid Carriers.” Symposium on Pharmaceutical Engineering Research SPhERe, 27 September 2019, discussed in Written Opinion for PCT/NL2023/050011, referenced in IDS of 15 July 2024), discloses a similar process as in FRANCKE (above), however the pressure is not reported for the microfluidizer homogenization procedure on p. 2.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOHN S KENYON whose telephone number is (571)270-1567. The examiner can normally be reached Monday-Friday 10a-6p.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Andrew D Kosar can be reached at (571) 272-0913. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JOHN S KENYON/Primary Patent Examiner, Art Unit 1625
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