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 .
Detailed Action
Filing Receipt and Priority
The filing receipt states that the instant application is a 371 of PCT/IB2021/060499, filed 11/12/2021. The filing receipt also states that the instant application claims foreign benefit of Italian application IT102020000027408, filed 11/16/2020.
The received certified copy of the Italian application supports the instant application. Therefore, the effective filing date is 11/16/2020.
Information Disclosure Statements
The information disclosure statements (IDS) received 05/08/2023 have been considered. The size assertion is also acknowledged.
Restriction/Species Election
The election without traverse of the following invention and species is acknowledged.
Applicant has elected Group I, claims 1-10 and 14.
Applicant has elected the following species:
-soy lecithin (lipid excipient),
-microcrystalline cellulose (hydrophilic excipient),
-no surfactants,
-nutraceutical formulations.
Although applicant did not explicitly state whether the election was made with or without traverse, applicant does not attempt to argue against the restriction requirement and species election. Therefore, the election is being treated as an election without traverse.
Status of Claims
Claims 1-5, 8-9, and 14 are under examination.
Claims 6-7 and 10-13 are withdrawn.
Rejections
Claim Rejections - 35 USC § 112(b)
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 4 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 4 states “wherein the lipid excipient is a sunflower or soy lecithin containing phosphatidylcholine in the amount of not less than 25%.”
Claim 4 does not include a unit. One of ordinary skill in the art would not know the exact metes and bounds of “25%”.
For the purpose of examination, the claim is interpreted to mean “25% of the total weight” of lecithin.
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.
(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.
Claim(s) 1, 3-5, 8-9, and 14 is/are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Renwick (US2018/0250262, of the record) as evidenced by List (Polar Lipids, 2015, p. 1-33), and Webster (Nutraceutical, url=https://www.merriam-webster.com/dictionary/nutraceutical, accessed 11/19/2025).
Claim 1 is drawn to a composition in solid dispersion form comprising CBD 2 and at least two excipients wherein at least one of the excipients is a lipid excipient and wherein the other excipient is a hydrophilic excipient. An additional limitation of claim 1 requires that the lipid excipient be present in an amount that is equal to or lower than 20% of the total weight of the composition.
Dependent claim 3 is drawn to embodiments wherein the lipid excipient is selected from mono-, di-, triglycerides, fatty acids, lecithins and combinations thereof. Claim 4 is drawn to lipid excipients which include sunflower or soy lecithin with a phosphatidylcholine content less than 25%.”
Claim 5 is drawn to embodiments wherein the hydrophilic excipient is selected from a number of excipients. See claim for full listing. Applicant has elected “microcrystalline cellulose” as hydrophilic excipient.
Claims 8 and 9 specify ratios of CBD to either lipid excipient (claim 8) and hydrophilic excipient (claim 9).
Claim 14 claims Oral or nutraceutical formulations comprising the composition of claim 1. Applicant has elected nutraceutical formulations.
Regarding claims 1, 3-5, and 8-9, Renwick on p. 8-10, examples 1-10 discloses compositions comprising cannabinoid resin, soy lecithin and ProSolv90 (silicified microcrystalline cellulose). Example 7 specifically contains soy lecithin in a weight % amount that is ~10%, a CBD to soy lecithin ratio 1:1, and a CBD to hydrophilic excipient ratio that is 1:1.
Renwick on p. 1, para. [0003] states “Cannabidiol (CBD) is another major constituent of the [cannabis] plant.” Renwick on p. 5, para. [0066] states “The cannabinoid extracts of the present invention can be extracted and formulated to provide a number of sustained release combination useful in the present invention. Of particular interest are …100% CBD tablets, 10:1 THC/CBD, 1:10 THC/CBD, and 50:50 THC/CBD.”
Regarding claim 5, List on p. 512 teaches that the content % of phosphatidylcholine within commercial soybean lecithin (soy lecithin) is 16%.
Regarding claim 14, applicant does not explicitly define “nutraceutical”. A definition taken from Webster teaches that “nutraceutical” is “a foodstuff (such as fortified food or dietary supplement) that provides health benefits in addition to its basic nutritional value.” The earliest use of this definition was 1990 as indicated by Webster on p. 2.
Therefore, the broadest reasonable interpretation of a “nutraceutical formulation” would include formulations that provide health benefits beyond their basic nutritional value. Renwick in para. [0011] states “Cannabidiol (CBD) is a non-psychoactive cannabinoid that been clinically demonstrated to have analgesic, antispasmodic, anxiolytic, antipsychotic, antinausea, and anti-rheumatoid arthritic properties.” The teaching of the compositions embraces the elements of claim 14.
Note: Applicant refers to the claimed compound as “CBD 2”. However, the compound CBD 2, is identical to CBD as known within the art. Therefore, the “CBD 2” is understood to be nomenclature used by the applicant to refer to CBD.
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.
KSR Rationales
The MPEP in section 2143, subsection I gives examples of Rationales for supporting a conclusion of obvious. These rationales are non-exhaustive and include (A) Combining prior art elements according to known methods to yield predictable results; (B) Simple substitution of one known element for another to obtain predictable results; (C) Use of known technique to improve similar devices (methods, or products) in the same way; (D) Applying a known technique to a known device (method, or product) ready for improvement to yield predictable results; (E) “Obvious to try” – choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success; (F) Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art; (G) Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention.
Claim(s) 1-5, 8-9, and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Renwick (US2018/0250262) as evidenced by List (Polar Lipids, 2015, p. 1-33), and Webster (Nutraceutical, url=https://www.merriam-webster.com/dictionary/nutraceutical, accessed 11/19/2025).
Discussion regarding the rejection of claims 1, 3-5, 8-9, and 14 from the 102 rejection above are incorporated here.
Claim 2 is drawn to an embodiment wherein the hydrophilic excipient is present in amount equal to or higher than 40% of the total weight of the composition.
While Renwick does not explicitly teach compositions comprising a hydrophilic excipient in amounts equal to or great than 40%, this modification falls within the skillset of one of ordinary skill.
The MPEP section 2144.05 states:
“The adjustment of particular conventional working conditions (e.g., determining result effective amounts of the ingredients beneficially taught by the cited references), is deemed merely a matter of judicious selection and routine optimization which is well within the purview of the skilled artisan. Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical.
“[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, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Accordingly, this type of modification would have been well within the purview of the skilled artisan and no more than an effort to optimize results.”
Essentially, one of ordinary skill could easily modify the amounts within the composition to optimize a formulation that has been taught within the art.
Therefore, it would have been prima facie obvious at the time of the effective filing date for one of ordinary skill in the art to have modified the composition of Renwick to read on the instant claims with a reasonable assumption of success. One of ordinary skill would find motivation to make the modification as it would be obvious to try to optimize the formulation taught by Renwick.
Examiner’s Comments
Compositions similar, if not identical to those in Renwick, are discussed in Lefler (US 10,772,837, published 2020). The Lefler reference shares an inventor with the Renwick reference above.
Conclusion
No claims allowed.
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/L.G./Examiner, Art Unit 1624
/SUSANNA MOORE/Primary Examiner, Art Unit 1624
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