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 mailed 09/12/2022 states the instant application is a 371 of PCT/US2020/057448, filed 10/27/2020 which claims benefit of provisional application 62/927,238, filed 10/29/2019.
The instant application finds support in both the PCT document and provisional application. Therefore, the instant effective filing date is 10/29/2019.
Information Disclosure Statement
The information disclosure statement submitted 04/07/2022 has been considered.
Election/Restriction
The elections made in the remarks submitted 06/20/2025 is acknowledged. Applicant has elected the following:
-Cannabinoid species: cannabidiol
-oil: sesame oil
-phosphatidylcholine: wherein R1 and R2 are oleyl groups (structure shown below).
-sugar: honey
-flavoring: maple
-acid: citrus acid
Applicant has further elected lemon juice as the species of citrus acid.
Elected Phosphatidylcholine (1,2-dioleylphosphatidylcholine)
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The elected species read on the following claims: 1-2,4-5,7,9,12-14,16,18 and 75-79.
Claims 3, 6, and 15 are withdrawn from further consideration being drawn to non-elected species.
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, 4-5, 7, 9, 12-14, 16, 18, and 75-79 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kaufman (US2018/0296493) in view of Manyikana (Pharm. Dev. Technol. 2016; 21(3), 354-366), Hoogevest (Eur. J. Lipid. Soc. Technol. 2014, 116, 1088-1107),), Ciriminna (Chemistry Central Journal, 2017, 11:22), and Marie (Marie, L., 1991, Handbook of Sweeteners, Springer).
In regards to claims 1, 2, 12-14, 16, 76-77, Kaufmann on p. 15, para. [0237]-[0244] teaches compositions comprising cannabinoids, phospholipids, and lipids. Kaufmann on p. 3, para. [0039] teaches cannabidiol (CBD) as a cannabinoid. Kaufmann on p. 15, para. [0245] teaches a composition comprising CBD.
Kaufmann on p. 13, para. [0199] contemplates the addition of sweeteners where it states “Preferred sweeteners for this disclosure should be natural sweeteners such as…erythritol.” Kaufmann on p. 13, para. [0201] contemplates the addition of flavorings agents.
Regarding claim 16, Kaufmann in para. [0200] teaches concentrations of sweeteners ranging from 0.05% to 2.5% w/w. While this range falls outside of the claimed percent by weight concentration of erythritol, the instant specification does not indicate whether the claimed concentration range imparts some characteristic feature that is critical to the claimed composition. The MPEP section 2144.05, subsection II 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.
Therefore, modifying the concentration of sweetener discussed in Kaufmann to what is instantly claimed would be within the skillset of one of ordinary skill and would therefore be obvious.
Kaufmann on p. 11, para. [0176] contemplates the addition of sesame oil as a lipid. Additionally, Kaufmann in para. [0030] and figure 4 teaches a composition comprising sesame oil.
Kaufmann on p. 3, para. [0036] contemplates phospholipids which includes “phosphatidylcholine”.
Kaufmann does not discuss explicitly discuss a solid matrix the elected phosphatidylcholine, honey, citric acid, lemon juice, or maple flavoring. This is addressed by the combination of Hoogevest, Ciriminna, and Marie.
Manyikana on p. 358, sec. Phase Transition Process teaches a process for creating solid tablets carrying drugs by compressing and heating two sugar alcohols (xylitol and erythritol) with said drugs. While Manyikana does not explicitly discuss cannabinoids, one of ordinary skill in the art would be able to modify the composition of Kaufman by incorporating the phase transition process. The benefits of this process is “media pore size and hardness of the tablets was increased resulting tablets with acceptable disintegrating properties and mechanical strength.”
Hoogevest teaches phospholipids as pharmaceutical ingredients. Regarding claims, 1, 12-14, and 76, Hoogevest on p. 1099, table 8 teaches 1,2-dioleylphosphatidylcholine (DOPC) as a synthetic phospholipid.
Ciriminna teaches citric acid as critical ingredient in biotechnology (title). Regarding claims, 1, 4, 9, 18, 75, 78, and 79 Ciriminna on p. 1, sec, Background states “Citric acid…is an acidulant, preservative, emulsifier, flavorant, sequestrant and buffering agent widely used across many industries in food, beverage, pharmaceutical, nutraceutical and cosmetic products.” Ciriminna continues “First crystallized from lemon juice…” indicating that citric acid is a component of lemon juice (claim 9, 18).
Regarding claim 5, 7, 75, 78, and 79, Marie teaches sweeteners (title). Marie on p. 54, sec. 3.2.2 Applications teaches honey as a common sweetener that can be used to extend shelf life as well as contribute sweetness in baked goods. Additionally, Marie on p. 54-55 teaches that Honey can be used to replace sugars or starch-based syrups in most food formulations.
Marie on p. 55, sec. 3.3 Maple syrup and sugar teaches Maple sweeteners (maple flavorings). Marie in this section teaches “The pure product [maple syrup] is more expensive, by an order of magnitude, than sucrose or starch-based sweeteners, and so many blends of maple syrup, with other syrups, or of other syrups with maple flavoring, are available…”.
One of ordinary skill could modify the composition of Kaufmann to include the sweeteners discussed in Marie as well as using the citric acid (lemon juice) of Ciriminna as a flavorant.
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 taught in Kaufmann by adding the honey, citric acid (lemon juice), and maple flavoring discussed in Ciriminna and Marie. One of ordinary skill in the art would also be able to incorporate the process of Manyikana to create a solid composition comprising the nanoparticles of Kaufman to arrive at the instant claims with a reasonable assumption of success. One of ordinary skill would find motivation to make the modifications to Kaufmann in that the flavorants can enhance the acceptability to consumers and the solid composition has beneficial “disintegrating properties and mechanical strength”.
The addition of Manyikana has been necessitated by amendments made to the claims.
Response to Arguments
Applicant argues that “Kaufman identifies a problem of how to deliver cannabinoids effectively, but he proposes a solution that is distinct from, and teaches away from, the applicant’s invention.”
Applicant states that “Kaufman teaches the use of phospholipid nanoparticles and delivering them as “NanoSphere liquid gels” to circumvent the “intrinsic problems of inhalation, oral and intraoral delivered cannabinoid compositions.” Applicant continues stating “He defines ‘Nanosphere’ as ‘phospholipid nanoparticles as liquid gels that are mostly less than 100 nm diameter’.
Comparing the instant invention, applicant states that the “invention achieves bioavailability in a different manner: trough the use of a solid matrix that does not require limitation on the size of cannabinoid particles. Because a solid matrix and a gel are mutually exclusive states, Kaufman not only fails to suggest the applicant’s invention as claimed in claim 1, but also Kaufman teaches away from that invention.”
Regarding dioleylphosphatidylcholine (DOPC), applicant states that “Hoogevest states that the synthetic phospholipids of Table 8 are only used for parenteral/injectable administration. Thus Hoogevest not only fails to teach the use of DOPC in a solid matrix, it also teaches away from that use.”
Regarding Ciriminna, applicant states that “neither Ciriminna nor Marie suggest using the applicant’s phosphatidylcholine as part of micelles of cannabinoids in a solid matrix.”
Finally, regarding Marie and the teaching of honey and maple as sweeteners, applicant states “Marie disclosed the use of honey to replace other sweeteners. Therefore, it teaches away from use both honey and maple. Moreover, the applicant notes that its combination of honey and maple is non-obvious in light of the prior art because the value of the combination lies in the ability of the honey to serve as a functional part of a solid matrix while the matrix adds flavor.”
While Hoogevest does show DOPC as suitable for parenteral administration, it’s use in oral administration is known as discussed in Moutardier (International Journal of Pharmaceutics, Vol. 260, Iss. 1, 2003). Moutardier in sec. 2.1 Production or radiolabeled liposomes teaches the use of DOPC as a radio label carrier in a radiolabeled liposome composition. This composition was then administered orally to rats as discussed in sec. 2.7 Body distribution of LSP after oral administration to rats.
Applicant argues that honey serves a functional part of the solid matrix. This is simply an intended use and does not make the use of honey as a sweetener distinct from its use within the solid matrix. Additionally, this is not reflected in the claims.
Regarding the “solid matrix” of applicant’s argument and claim 1, the term “solid matrix” is not explicitly defined within the specification. The only instances of “solid matrix” within the instant specification are in discussion in para. [0097]-[0098], which do not explain the structure or components of the “solid matrix.” There is discussion of “sugar matrix” throughout the specification and in Figure 1, but it is not explicitly clear that the two terms are interchangeable. Nonetheless, sugar matrixes are well-known within the art as discussed in Manyikana (Pharm. Dev. Technol. 2016; 21(3), 354-366)
Manyikana in sec. Phase transition process states “This process involves using a combination of low- and high-melting point alcohols during a process of phases transitions to manufactures [Oradispersible drug delivery technologies (ODDT)] bypassing the need to use special equipment. ODDTs are manufactures by compressing the powder containing two sugar-alcohols of high-and low-melting points followed by a heating process at a temperature between the melting points of the two sugar alcohols. Kuno prepares ODDTs in tablet form by compressed powder containing xylitol and erythritol followed by heating at ~93o C for 15 min.” This process is similar to the process within figure 1 and the process in para. [0072]. Para. [0072] states “The sugar matrix is formed by the combination of erythritol and sugars, if present, with acid and water.”
Regarding the discussion of the “NanoSphere liquid gel” of Kaufman, there is significant discussion of phospholipid nanoparticles, “NanoSpheres” and liquid gels within Kaufman. Kaufman in para. [0035] states “The term ‘NanoSphere’ in the present disclosure refers to phospholipid lipid nanoparticles as liquid gels…” as stated by applicant. However, applicant assumes that “liquid gels” here refers to the physical form of the phospholipid nanoparticles and not the full composition.
Kaufman gives more details in para. [0157]-[0161] where Kaufman states “Lipid nanoparticles may be assembled as solid lipid nanoparticles (SLN), nanostructure lipid carriers (NLC), and NanoSpheres (NS). Kaufman continues “’Solid lipid nanoparticles (SLN)’ are colloidal drug carriers and dynamic structures that are typically synthesized from phospholipids, lipids, and excipients. They are composed of an outer phase membrane of lipids and/or phospholipids and inner phase solid lipid inner core.”
Additionally, the cited example in the rejection refers to a “Basic Intraoral Cannabinoid Phospholipid Nanoparticle Carrier”. There is no indication regarding the physically structure of the composition. Additionally, Kaufman, para. [0245] Example 1 details the process for the preparation of its “THC Cannabinoid Phospholipid Nanoparticle Carrier Composition”. Kaufman’s process involves dissolving the phospholipid or phospholipids, in a vessel under heating and addition of a cannabis sativa extract. This resulting composition is then homogenized and cooled to form the phospholipid nanoparticle cannabinoid composition.
Therefore, each limitation is known within the art and each are also predictable. That is, one of ordinary skill in the art could predictably modify the composition of Kaufman to include the ingredients of Hoogevest, Ciriminna and Marie and further modify the composition to incorporate the solid tablet of Manyikana with a reasonable assumption of success. See KSR Rationale D.
Specification
New Objection
Drawings include notations to blank features which are not discussed in the specification. See Figure 3, below.
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“300” points to blank space and the instant specification, para. [0097]-[0099] do not explain what the blank space represents. Discussion of Figure 3 in para. [0022] is also lacking explanation. Similarly, figure 2 uses “200” but does not explain what “200” is.
Conclusion
No claims allowed
THIS ACTION IS MADE FINAL. 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.
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/L.G./Examiner, Art Unit 1624
/SUSANNA MOORE/Primary Examiner, Art Unit 1624