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 statement (IDS) received 03/03/2026 has been considered. The size assertion is also acknowledged.
Restriction/Species Election
The election without traverse of the following invention and species is acknowledged.
Applicant elected Group I, claims 1-2, 5-10 and 14.
Applicant elected the following species:
-soy lecithin (lipid excipient),
-microcrystalline cellulose (hydrophilic excipient),
-no surfactants,
-nutraceutical formulations.
Status of Claims
Claims 1-2, 8-9, and 14 are under examination.
Claims 6-7 and 10-13 are withdrawn.
Withdrawn Rejections
In view of the amendments made, the 112(b) rejection made in the prior office action has been withdrawn.
Modified Rejections
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) 1-2, 5, 8-9, and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jamwal (Journal of Integrative Medicine, 16, 2018, 367-374) in view of Millar (Pharmaceuticals, 2020, 13, 219, published 10/28/2020), and Renwick (US2018/0250262) as evidenced by 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.
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.
Jamwal on p. 369, sec. 3.1.1. teaches the composition commercially known as Meriva®. Jamwal states “Meriva® is a curcumin-phosphatidylcholine phytosome complex of soy lecithin, microcrystalline cellulose and 18-20% curcuminoids.” Jamwal continues “One curcumin is complexed with phosphatidylcholine, the hydrophobic core of the phytosome protects it from degradation while increasing the cellular uptake though facilitated diffusion across lipophilic cell membranes. A randomized, double-blind, crossover study in human found that curcumin absorption was about 29-fold higher for Meriva® compared to unformulated curcuminoid mixture.” Jamwal on p. 368, para. 2 states “Curcumin is currently marketed as a dietary supplement in many countries worldwide and also carries a generally recognized safety status. However, despite the proven preclinical efficacy, poor solubility, low absorption from the gut, rapid metabolism, and rapid systemic elimination contribute to an overall low oral bioavailability. Curcumin is a hydrophobic molecule with a logP of 3.2, which makes it practically insoluble in water.”
Jamwal does not discuss CBD. This is addressed by the combination of Millar.
Millar discusses delivery of cannabidiol (title). Millar in sec. 2, para. 1 states “Poor bioavailability…generally leads to insufficient therapeutic efficacy and is more likely to produce high interindividual variability in pharmacokinetic (PK) parameters. In this context, the bioavailability of CBD varies greatly with route and mode of administration. The oil/water partition coefficient (Log P) describes a drug preference which exists either in the water or oil part of a solution; higher log P values mean more of the drug will be distributed in the oil part of the solution. Due to the highly lipophilic nature of CBD (Log P 6.3), it is most commonly supplied as an oil or alcoholic formulation either in soft-gel capsules, liquid solution…”. The log P of CBD indicates poor water solubility, similar to curcumin.
Considering the above teachings, one of ordinary skill in the art would find it obvious to modify the composition discussed in Jamwal to instead use CBD in place of curcumin in order to take advantage of the increased drug delivery and drug protection afforded via the combination of soy lecithin and microcrystalline cellulose.”
Regarding claims 2 and 8-9, and the limitation “soy lecithin containing a phosphatidylcholine in an amount of not less than 25% of the total weight of the composition, 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.
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.”
Considering the teachings above, one of ordinary skill in the art would find it obvious to modify the composition taught in Jamwal to include CBD in place of curcumin. One of ordinary skill would also find it obvious to modify the composition to the specific percentages and ratios as claimed in claims 1, 2, and 8-9. One of ordinary skill would also find claim 14 obvious in view of the teachings of Renwick.
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 modify the composition of Jamwal to include CBD in the percentages and ratios as claimed with a reasonable assumption of success. One of ordinary skill would be motivated to make the modification as Jamwal teaches the improved drug delivery from the combination of soy lecithin and microcrystalline cellulose which can be applied to poorly soluble compounds such as CBD. See KSR bullet B.
The modification of this rejection is necessitated by amendments made to the claims.
New Rejection
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 1-2, 5, 8-9, and 14 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 1 states “A composition in solid powder dispersion form consisting of…at least two excipients, wherein at least one excipient (“excipient L”) is a lipid excipient and wherein at least one excipient (“excipient I”) is a hydrophilic excipient…”.
The use of both “consisting” and “at least two” is indefinite. “Consisting” is considered closed limiting language. The use of “at least” is open-ended language. Therefore, it is not clear if applicant intends to limit the claim to the combination of CBD, and excipient L and excipient I or if applicant also claims additional excipients.
As claims 2, 5, 8-9, and 14 are dependent on claim 1, they are also rejected.
This new rejection has been necessitated by amendments made to the claims.
Conclusion
No claims allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LUISALBERTO GONZALEZ whose telephone number is (571)272-1154. The examiner can normally be reached M-F 8:30-5:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey Murray can be reached at (571) 272-9023. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/L.G./Examiner, Art Unit 1624
/JEFFREY H MURRAY/Supervisory Patent Examiner, Art Unit 1624
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