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
Response to Amendment
Status of the Claims
Receipt of Applicant’s response, filed 14 Aug 2025 has been entered.
Claims 1-15, 24, 28, 32, and 37 remain pending in the application.
Claims 1, 2, 4, 5, 7, 9, 12, and 15 are amended.
Claims 16-23, 25-27, 29-31and 33-36 are cancelled.
Claims 6, 9-11, 24, 28, 32 and 37 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Claims 1-5, 7, 8 and 12-15 are under consideration to the extent of the elected species, i.e., that the cannabinoid is CBD, the dispersing agent is PEG300 and the cyclodextrin is HPβCD.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 10 Jun 2025 is in compliance with the provisions of 37 CFR 1.97, except where noted. Accordingly, the information disclosure statement is being considered by the examiner.
Objections Withdrawn
Objections to the Specification
The specification objections set forth in the Non-Final Office Action mailed 25 Feb 2025 are hereby withdrawn in light of applicant’s amendments of the specification.
Objections to the Claims
The claim objections set forth in the Non-Final Office Action mailed 25 Feb 2025 are hereby withdrawn in light of applicant’s amendments of the claims.
Rejections Withdrawn
Rejections Pursuant to 35 USC § 112
The rejections of claims 1-5, 7, 8 and 12-15 pursuant to 35 U.S.C. 112(b) set forth in the Non-Final Office Action mailed 25 Feb 2025 are hereby withdrawn in light of applicant’s amendment of the claims.
Rejections Maintained
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-5, 7, 8 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Donsky et al. (WO 2015/068052, published 14 May 2015, listed in IDS filed 27 Sep 2022) as evidenced by the instant specification.
Donsky teaches liposome formulations of terpenes and cannabinoids where the liposomes encapsulate a cannabinoid (title, abstract, [0036]). Donsky teaches that cannabinoid may be cannabidiol ([0024]). Donsky teaches adjusting the liposome such that the rate of release of the cannabinoid can be controlled ([0067]) and additionally teaches dosage forms coated using compounds that accelerate or decrease the release of active agents ([0064]), rendering obvious a “prolonged release formulation” as in claim 1. Donsky teaches that the liposomes encapsulate the cannabinoid ([0036] and further teaches components as associated with the lipophilic membrane or entrapped in the aqueous fluid that forms the core of the liposome ([0037]), rendering obvious the liposome having a lipid membrane and an intraliposomal aqueous core with entrapped cannabinoid as in clam 1. Donsky further teaches the inclusion of additives such as solubilizers which may be PEG 300 ([0068]), rendering obvious the dispersing agent/solubilizer/co-solvent of claims 1, 5, 7 and 8.
Donsky teaches that the amount of the cannabinoid in the solutions as from about 10% w/w to about 80% w/w ([0030]) and teaches phospholipids for obtaining the liposomes ([0026]) and that the phospholipid content is from about 20 to about 99% ([0030]). These weight percent ranges for the cannabinoid and the phospholipid render obvious the mole ratio range of cannabinoid to liposome between 1 to 10 as recited in claim 15. For example, Donsky teaches lipids such as phosphatidylcholine ([0023]), which has a molar mass of about 786.1 g/mol. The cannabinoid cannabidiol has a molar mass of about 314.47 g/mol. Assuming a total weight of 100 g of solution for the example, the 10-80% w/w cannabinoid taught by Donsky results in about 0.03-0.25mol cannabidiol and the 20-99% phospholipid results in about 0.03-0.13 mol of phosphatidylcholine
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. This results in a ratio of the cannabidiol to the phospholipid phosphatidylcholine of 0.3:1 to 8.3:1 which renders obvious the recited ratio between 1 to 10. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976).
Donsky does not expressly teach selecting the cannabidiol and PEG 300 as part of the liposomal formulations with sufficient specificity to rise to the level of anticipation.
However, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to have formed liposomes encapsulating cannabidiol and that contain PEG 300. One of ordinary skill in the art would have been motivated to do so as liposomal formulations comprising cannabinoids such as cannabidiol and including solubilizers such as PEG 300 are taught by Donsky. Adjusting the liposome to control the release rate and the coating dosage forms decrease the release of active agents is known from the teachings of Donsky, Thus, one of ordinary skill in the art would have a reasonable expectation of successfully forming a prolonged release liposomal formulation comprising cannabidiol and PEG 300 as they are known by Donsky since the modification of the prior art represents nothing more than the predictable use of prior art elements according to their established functions.
Regarding the limitations of claims 1, 3 and 4 that at least a portion of the cannabinoid and dispersing agent are entrapped within said intraliposomal aqueous core and claim 15 that at least a portion of the cannabinoid is entrapped in the lipid membrane, these limitations would necessarily be met from the formation of the liposomes as taught by Donsky. The examiner notes that the claims merely require that a “portion” of the cannabinoid/dispersing agent is in the aqueous core lipid membrane. Thus, even the smallest amount of the component would qualify as a “portion” as there is no limitation on the exact amount that needs to be in the membrane or core. As evidenced by the specification, cannabinoid will at least partially embed within the lipid membrane due to the hydrophobicity of the cannabinoid (page 6 lines 23-25). It is further evidenced by the instant specification that the dispersing agent physically associates with the cannabinoid and becomes entrapped within the liposomes (page 8 lines 18-20) and the dispersing agent maintains cannabinoid in the intraliposomal aqueous medium (page 9 lines 1-2). Thus, the cannabinoid cannabidiol will necessarily embed at least partially in the lipid membrane due to the hydrophobicity of the cannabinoid and the PEG 300 would associate with the cannabidiol which would allow at least a portion of the cannabidiol to be entrapped in the aqueous core. "[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer." Atlas Powder Co. v. IRECO Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus, the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977).
Accordingly, the instant claims are rendered prima facie obvious over the teachings of Donsky.
Response to Arguments
Applicant's arguments filed 14 Aug 2025 have been fully considered but they are not persuasive. Applicant argues that Donsky does not teach co-encapsulation of both the cannabinoid and a dispersing agent within the aqueous core of the liposome and that Donsky’s PEG 300 is part of the external formulation (page 9 of remarks). The examiner does not find this persuasive as Donsky teaches the inclusion of components as associated with the lipophilic membrane or entrapped in the aqueous fluid of the core ([0037]) so it is obvious to include components in the core and the inclusion would also occur as a part of the formation as noted in the rejection. As further evidence to the point, Donsky identifies carriers that may be entrapped within the aqueous core ([0037]) as components such as ethanol and polyols such as polyethylene glycol ([0066]). Thus, there it is obvious to include such components in the core and it is expected that at least a portion of the components would be encapsulated from the preparation of the formulation. The applicant looks to the instant specification to argue that the deliberate inclusion of the dispersing agent within the liposome core improves the sustainability of the liposome (page 9 of remarks) and that Donsky can’t be considered to teach cannabinoid and dispersing agent entrapped within the liposome wherein the dispersing agent is effective to disperse said cannabinoid in an aqueous phase (page 10 of remarks). This is not persuasive as the broadest reasonable interpretation of the claims does not require that the dispersing agent is present in the core in a certain amount or that it maintains the cannabinoid liposomes with a certain level of sustainability or dispersion. It may have been the intention of the applicant that “the present invention specifically and deliberately incorporates the dispersing agent within the liposome in a manner that facilitates cannabinoid solubility and retention” (as noted on page 9 of remarks) but this kind of limitation is not required per the claims. Thus, the arguments are not persuasive to overcome the rejection.
Claims 12-14 are rejected under 35 U.S.C. 103 as being unpatentable over Donsky et al. (WO 2015/068052, published 14 May 2015, listed in IDS filed 27 Sep 2022) as evidenced by the instant specification as applied to claims 1-5, 7, 8 and 15 above and further in view of Gharib et al. (Journal of Drug Delivery Science and Technology 44, 13 Dec 2017, 101–107).
Donsky teaches freeze-drying liposomes to a powder ([0100]) and teaches the inclusion of various additives such as stabilizers to the formulations ([0068]), but does not teach the inclusion of HP-β-CD. This deficiency is made up for in the teachings of Gharib.
Gharib teaches that cyclodextrin inclusion complexes improve the bioavailability, the stability of drugs, and limit their toxic effects (page 101 left column). Gharib teaches that to ensure stable encapsulation of lipophilic drugs, cyclodextrin/ drug inclusion complexes may be inserted into liposomes (page 101 left column). Gharib teaches that HP-β-CD liposomes have been shown stable after storage and that cyclodextrins are known for their cryoprotectant ability during lyophilization of liposomes (page 102 left column). Gharib teaches that HP-β-CD protects liposomes during freeze-drying when present in the interior aqueous compartment of liposomes (page 106 Conclusions).
Therefore, it would have been prima facie obvious to one of ordinary skill in the
art, before the effective filing date of the claimed invention to have included HP-β-CD in the liposomal formulations of Donsky. The liposomal formulations may include additives such as stabilizers and may be freeze-dried, as taught by Donsky, and cyclodextrins such as HP-β-CD are known to improve stability and offer cryoprotectant ability to liposomes during freeze-drying. Thus, one of ordinary skill would have a reasonable expectation of success in improving the stability of the liposomes rendered obvious from Donsky by including HP-β-CD in the liposomal formulations as HP-β-CD is known to offer this improvement to liposomal formulations.
Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by the references.
Response to Arguments
Applicant's arguments filed 14 Aug 2025 have been fully considered but they are not persuasive. Applicant argues that Gharib does not suggest that HP-β-CD contributes to prolonged release (page 10 of remarks). This is not persuasive as it is not necessary for the art to teach the same reason for including the cyclodextrin as the reason used by the applicant. The reason or motivation to modify the reference may often suggest what the inventor has done, but for a different purpose or to solve a different problem. It is not necessary that the prior art suggest the combination to achieve the same advantage or result discovered by applicant. See, e.g., In re Kahn, 441 F.3d 977, 987, 78 USPQ2d 1329, 1336 (Fed. Cir. 2006) (motivation question arises in the context of the general problem confronting the inventor rather than the specific problem solved by the invention). In KSR Int' l Co. v. Teleflex Inc., 550 U.S. 398 (2007), the Supreme Court cautioned that, "[i]n determining whether the subject matter of a patent claim is obvious, neither the particular motivation nor the avowed purpose of the patentee controls. What matters is the objective reach of the claim. If the claim extends to what is obvious, it is invalid under § 103." Id. at 419. The inclusion of HP-β-CD is obvious as it is known to improve stability of liposomes as noted in the rejection. The applicant argues that Gharib does not teach the inclusion of a non-CD dispersing agent co-encapsulated with the cannabinoid to achieve controlled release (page 10 of remarks). The examiner again notes that it is not necessary for the art to teach the same reasons for combining, such as controlled release, as used by the applicant. More directly though, the examiner notes that Gharib was relied upon for including HP-β-CD, not for including a non-CD component and thus this argument does not address the reason for using the teachings of Gharib. The inclusion of a non-CD dispersing agent was obvious from the teachings of Donsky as described above.
Conclusion
No claims are allowed.
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 extension fee 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 date of this final action.
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/E.C.M./Examiner, Art Unit 1619 /BENNETT M CELSA/Quality Assurance Specialist , Art Unit 1600