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
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 18 May 2026 has been entered.
Response to Amendment
Status of the Claims
Receipt of Applicant’s response, filed 18 May 2026 has been entered.
Claims 1-3, 5-15, 24, 28, 32, and 37 remain pending in the application.
Claims 1, 3, 12, 15, 24, 28, and 37 are amended.
Claims 4, 16-23, 25-27, 29-31, and 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Claims 6, 9-11, 24, 28, 32 and 37 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.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 1-3, 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.
Rejections Maintained – in modified form
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.
The rejection below was previously applied and has been modified to better address the current claim limitations.
Claims 1-3, 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 that drugs and carriers can be 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 and that drug and carrier components may be in the membrane or the core of the liposome. Donsky teaches that suitable carriers, diluents, solvents or vehicles include polyols such as polyethylene glycol ([0066]). Donsky further describes the suitability of polyethylene glycol with the compositions by noting it additionally as an emulsifier ([0060]) and solubilizer ([0068]). Donsky further teaches the polyethylene glycol PEG 300 as suitable for formulations of the invention ([0068]), thus indicating PEG 300 as a polyethylene glycol known to be suitable with components of the invention and an obvious glycol to include.
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
e
.
g
.
f
o
r
10
%
w
w
c
a
n
n
a
b
i
d
i
o
l
%
w
w
100
*
t
o
t
a
l
w
e
i
g
h
t
m
o
l
a
r
m
a
s
s
=
10
%
100
*
100
g
314.47
g
m
o
l
=
0.03
m
o
l
. 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 the aqueous core comprising the cannabinoid and dispersing agent 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 a polyethylene glycol such as PEG 300 and where the cannabidiol is in the membrane and the core of the liposome. One of ordinary skill in the art would have been motivated to do so as liposomal formulations comprising cannabinoids such as cannabidiol and carriers such as polyethylene glycol are taught by Donsky and it is further known from Donsky that drug and carrier components may be in the membrane or aqueous core of the liposomes. PEG 300 is a specific polyethylene glycol known from Donsky to be suitable with the liposomal formulations and thus it would be obvious to one of ordinary skill to use PEG300 as it is already known as suitable with the formulations. Adjusting the liposome to control the release rate and coated dosage forms decreasing the release of active agents is known from the teachings of Donsky and thus, one of ordinary skill in the art would have a reasonable expectation of successfully forming a liposomal formulation with prolonged release that comprises cannabidiol and PEG 300 as they are known by Donsky and the modification of the prior art represents nothing more than the predictable use of prior art elements according to their established functions.
Regarding the limitation that the dispersing agent forms a non-covalent linkage with the cannabinoid and is present aqueous core in an amount sufficient to prolong the release of the cannabinoid from the liposome by maintaining the cannabinoid in the core in a dissolved or dispersed form, these limitations would necessarily be met from the formation of the liposomes that are obvious from the teachings of Donsky. As described above, it is obvious from Donsky to form liposomes with cannabidiol and polyethylene glycol carriers where drug and carriers are in membrane or core components of the liposomes. A non-covalent linkage merely describes the association between the cannabidiol and the polyethylene glycol that forms as the components are brought together and the maintaining in dissolved/dispersed form merely describes the result of that interaction. As evidenced by the instant specification, the dispersing agent physically associates with the cannabinoid and becomes entrapped within the liposomes in the form of non-covalent complexes (page 8 lines 18-20) and the dispersing agent maintains cannabinoid in the intraliposomal aqueous medium and facilitates the controlled release of the active ingredient (page 9 lines 1-2). Thus, the combination of the cannabinoid cannabidiol and the polyethylene glycol, as is obvious from Donsky, would result in the non-covalent linkage between the components and the maintaining in dispersed/dissolved form. "[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). Regarding the limitation that the dispersing agent is “in an amount sufficient to prolong the release” the examiner notes that the polyethylene glycol is described by Donsky as a carrier/diluent/solvent/vehicle which implies that the glycol is present in an amount sufficient to serve these functions and would be a significant component of the formulation. There is no definition or indication in the claim or the specification to limit what the “amount” of the dispersing agent is and the claim does not further limit what is meant by “prolong.” As it is obvious to include the polyethylene glycol as a carrier and this would necessarily result in the association with the cannabidiol, as described above, the examiner understands that the addition of polyethylene glycol as is obvious from Donsky would be in an “amount sufficient to prolong the release.”
Accordingly, the instant claims are rendered prima facie obvious over the teachings of Donsky.
Response to Arguments
Applicant's arguments filed 18 May 2026 have been fully considered but they are not persuasive. Applicant argues that the functional language requiring that the dispersant is at an amount sufficient to prolong the release of the cannabinoid from the liposome is not disclosed by Donsky and that Donsky does not teach how to prolong the release of the cannabinoids from the core (page 8 of remarks). Applicant notes that Donsky teaches that pharmaceutically acceptable carriers may be entrapped in the core but argues that Donsky teaches fast-acting liposomes and not prolong release of the actives (page 8 into 9 of remarks). Applicant argues that the teaching of Donsky regarding polyethylene glycol as a carrier is in the context of the formulation for administration and not the components used to make the liposomes and that this does not provide motivation to use the excipients within the core of the liposomes (page 9 of remarks). Applicant argues that the art does not teach the non-covalent linkage with the cannabinoid and prolonged release from the liposomes (page 10 of remarks). Applicant argues that it is improper for the examiner to use the applicant’s specification to establish what will physically happen when the prior art elements are combined as the non-covalent linkage is an important part of the present invention and is not prior art (pages 10-11 of remarks). Applicant argues that the claim now written explicitly requires an amount of dispersing agent sufficient to prolong the release of the cannabinoid from the liposome by maintaining in a dissolved or dispersed form and this amount is not disclosed by Donsky (page 11 of remarks). Applicant argues that the language requires that enough dispsersant to be present to have a practical effect on the rate of release (page 12 of remarks).
The examiner does not find these arguments persuasive. As described above, Donsky teaches that drug and pharmaceutically acceptable carrier components may be included in the liposome membrane or entrapped in the aqueous fluid of the liposome core ([0037]). Thus, it is obvious that such components may be included in either the membrane or the core of the liposome. It is true, as the applicant notes, that Donsky teaches fast acting systems, but Donsky also teaches decreasing the release of active agents (e.g. [0064]) thus rendering obvious a prolonged release formulation. While the applicant may not use a coating, the claims do not preclude such a coating. While Donsky does describe polyethylene glycol as a carrier in the context of the formulations, as noted by the applicant, it still is known that polyethylene glycol can serve as a carrier. Given the favorable disposition that Donsky takes with polyethytlene glycol by indicating its suitability as a carrier and further indicating it for uses such as an emulsifier and solubilizer, it is clear that polyethylene glycol is a suitable component for the compositions, thus providing a reasonable expectation of success in using it as a component such as a carrier with the liposomes. Donsky teaches including components such as carriers in the aqueous core and there certainly is nothing teaching against the use of polyethylene glycol and the broad utility of polyethylene glycol with the invention, as taught by Donsky, provides sufficient reason for its inclusion with the liposome, including the aqueous core of the liposome. Regarding the arguments around the functional language of non-covalent linkage, the examiner holds that such a property is a result of including the components as is obvious from Donsky. The examiner notes the instant specification was not used in the rejection as prior art to render the feature obvious, but rather as evidence to indicate that such as property would be present when from the combination of the components. There is nothing to indicate that the non-covalent linkage requires anything further added to the composition or any specific processing that would not be obvious from Donsky. While the applicant may have determined that such a linkage occurs between the components, 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). Regarding the “amount sufficient to prolong the release of the cannabinoid,” the examiner does not find that this limitation clearly distinguishes the claimed formulation from that of Donsky. The limitation is broad and there is no indication in the claim or the specification that a specific amount (such as a certain ratio) is needed to maintain the cannabinoid in the core and the claims do not require a specific amount of cannabinoid to be present in the core that has to be maintained and do not require that the cannabinoid be maintained for a specific amount of time in the core. Thus, only a small amount of cannabinoid (i.e. above 0%) would need to be present to meet the claim limitation and any extension of the release time would meet the limitation that the release is prolonged. As only a small amount of cannabinoid needs to be present and the release only needs to delayed by any amount, this leads to the expectation that there would not need to be much polyethylene glycol present to meet the limitation. As Donsky describes polyethylene glycol in the context of carrier/diluent/solvent/vehicle, emulsifier, solubilizer, it is understood that a sufficient amount of the glycol would need to be present to have these functions, and absent evidence to the contrary, this is understood to meet the limitation the dispersing agent is in an “amount sufficient to prolong release.” The examiner notes again that it is not necessary for the art to describe features that are necessarily present and based on the current evidence it is understood that including the polyethylene glycol in the core, as is obvious, would necessarily meet the limitation of prolonged release.
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.
New Grounds of Objections/Rejections
Claim Objections
Claim 13 is objected to because of the following informalities: “Solfobutyl ether” should be spelled “sulfobutylether.” Appropriate correction is required.
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.
Claim 1-3, 5, 7, 8, and 12-15 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 1 recites the limitation "said dispersing agent forms a non-covalent linkage". There is insufficient antecedent basis for this limitation in the claim. Base claim 1 recites “at least one dispersing agent”, which encompasses multiple dispersing agents, and it is unclear whether “said dispersing agent” includes just one or more than one dispersing agents. Amending the claim to recite “said at least one dispersing agent forms a non-covalent linkage” would overcome this rejection. Claims 2, 3, 5, 7, 8, and 12-15 are included in this rejection as they depend directly, indirectly, or include all the limitations of independent claim 1.
Claim 15 is indefinite in the recitation of “a mole ratio between said cannabinoid and said one or more liposome forming lipids in the range between 1 to 10.” It is unclear what is meant by describing the ratio as in the range between “1 to 10.” Ratios express the relative amount of one component to another and it is unclear if a range between 1 to 10 is intended to require a ratio of 1:10, or 1:1 to 1:10, or 1:1 to 10:1. Thus, the metes and bounds of the claim cannot be determined.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-3, 5, 7, 8, and 12-15 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The amendment filed 18 May 2026 has introduced new matter into the claims. Amended claim 1 recites that the “dispersing agent…is present in an amount sufficient to prolong the release of the cannabinoid”. The response filed 18 May 2026 indicates that support for amended claim 1 can be found on page 9, lines 1-4, and page 13 lines 26-27. This has been fully considered but is not found persuasive. The originally filed disclosure at these locations describe the dispersing agent controlling the release of the active ingredient, but there is nothing indicating that the agent is in an “amount sufficient” for prolonging the release.
Instant claim 1 now recites limitations, which were not clearly disclosed in the specification as filed, and now change the scope of the instant disclosure as filed. Such limitations recited in newly amended claim 1, which did not appear in the specification, as filed, introduce new concepts and violate the description requirement of the first paragraph of 35 U.S.C 112. Applicant is required to provide sufficient written support for the limitations recited in present claim 1 in the specification or claims, as-filed, or remove these limitations from the claims in response to this Office Action. Claims 2-3, 5, 7, 8, and 12-15 are included in this rejection as they depend directly, indirectly, or include all the limitations of independent claim 1.
Conclusion
No claim is allowed.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to EDWIN C MITCHELL whose telephone number is (571)272-7007. The examiner can normally be reached Mon-Fri 8:00-5:00.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David Blanchard can be reached on (571)272-0827. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/EDWIN COLEMAN MITCHELL/Examiner, Art Unit 1619
Prosecution Insights