DETAILED ACTION
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 .
Status of Application
Receipt of Applicant’s remarks and amended claims filed on February 18, 2026 is acknowledged.
Claims 1-5, 9, 13-14, 16, 18-19, 27-31, and 38-43 are pending in this application.
Claims 6-8, 10-12, 15, 17, 20-26, and 32-37 have been cancelled.
Claims 1, 4, 16, and 27 have been amended.
Claims 42-43 are new.
All pending claims are under examination.
Withdrawn Objections/Rejections
Claim Objections
The objection of claim 16 because the claim should read “is comprised in a liquid formulation” has been withdrawn in view of the amendment to the claim to recite “wherein the nanoparticle composition is comprised in a liquid formulation….”.
Claim Rejections - 35 USC § 112
The rejection of claim 13 under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends because claim 1, from which 13 depends, recites the surfactant is an optional component, therefore the particle would be surfactant free has been withdrawn in view of the amendment to claim 1 to delete the optional component language.
Claim Rejections - 35 USC § 102
The rejection of claims 1-5, 9, 13-14, 28-29, 31, 38 and 40 under 35 U.S.C. 102(a)(1) as being anticipated by Kaufman (US 2017/0000744) has been withdrawn in view of the amendments to claim 1 to recite the “at least one active agent comprising an unenriched extract, full spectrum extract, or broad spectrum extract”.
Maintained Rejections
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.
Claims 1-5, 9, 13-14, 18, 27-31, 38, 40-43 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sloat et al. (WO 2020/123407).
Sloan discloses a nanoparticle-based composition and their use in methods (abstract).
Claim 1 discloses a lipid-based particle composition comprising:
a nanoparticle comprising:
cannabidiol (CBD) at a weight percent in the composition ranging from 1% to 10%;
a phosphatidylcholine at a weight percent in the composition ranging from 2.5% to 15%;
a sterol at a weight percent in the composition ranging from 0.5% to 5%; and
a medium chain triglyceride at a weight percent in the composition ranging from 2.5% to 15%; and
water at a weight percent in the composition ranging from 60% to about 80%; wherein the nanoparticles have an average size ranging from about 75 nm to about 200 nm; and
wherein, upon storage for a period of one month, the average size of the nanoparticles changes by less than about 20%.
Example 13 discloses the CBD origin is from a full spectrum or a broad spectrum hemp extract.
Regarding claims 2-4, as noted above, the active agent is cannabidiol. A flavoring agent can also be added (paragraph 0084).
Regarding claim 5, CBD is a small molecule. While CBD is recited in the embodiments, it is disclosed that other hydrophobic therapeutic agents or nutrients can be employed such as fish oil, vitamin D and other lipid soluble vitamins (paragraph 0046).
Regarding claim 9, as noted above, the particle comprises phosphatidylcholine.
Regarding claim 13, the composition recited in claim 1 does not require a surfactant.
Regarding claim 14, the lipid-based particle composition (e.g., when in water or dried) comprises multilamellar nanoparticle vesicles, unilamellar nanoparticle vesicles, multivesicular nanoparticles, emulsion particles, irregular particles with lamellar structures and bridges, partial emulsion particles, combined lamellar and emulsion particles, and/or combinations thereof. In some embodiments, the composition is characterized by having multiple types of particles (e.g., lamellar, emulsion, irregular, etc.) (paragraph 0090).
Regarding claims 18 and 30, the composition can further comprise a preservative comprising one or more of citric acid, potassium sorbate, sodium benzoate, and vitamin E (paragraph 0014). The sterol is disclosed to include medium chain triglycerides include capric and caprylic acid (paragraph 0007). Applicant’s attention is directed to Example 1.
Regarding claim 27, claim 13 recites a lipid-based particle composition comprising:
a particle comprising:
cannabidiol (CBD) at a weight percent in the composition ranging from 5% to 20%;
a phosphatidylcholine at a weight percent in the composition ranging from 35% to 60%’
a sterol at a weight percent in the composition ranging from 2.5% to 10%; and
a medium chain triglyceride at a weight percent in the composition ranging from 35% to 50%;
wherein the composition has a Cmax of 80 ng/ml after oral dose of 15 mg/kg to a subject. Claim 14 recites the composition is a dry powder, thereby indicating the composition is free of water.
Regarding claim 28, as noted above, the composition comprises cannabidiol. Claim 19 additionally recites the inclusion of a flavoring agent.
Regarding claims 29 and 40, the lipid based particle composition is in the form and/or comprises one or more of liposomes, an oil in water nano emulsion (and/or microparticle emulsion) and/or solid lipid particles (paragraph 0017).
Regarding claim 31, the particles comprising CBD can be used to alleviate pain, treat epilepsy, and the treatment of certain neurological disorders (paragraph 0003).
Regarding claim 38, the nanoparticle powder can be reconstituted to provide a nanoparticle composition (claim 4). The lipid based particle composition is additionally disclosed to be aqueous (paragraph 0009).
Regarding claim 41, Sloat discloses preparation of compositions having different combinations of particles, for example, paragraph 0090 discloses, in some embodiments, the composition is characterized by having multiple types of particles (e.g., lamellar, emulsion, irregular, etc.). In other embodiments, a majority of the particles present are emulsion particles. In several embodiments, a majority of the particles present are lamellar (multilamellar and/or unilamellar). In other embodiments, a majority of the particles present are irregular particles. In still other embodiments, a minority of the particles present are emulsion particles. In some embodiments, a minority of the particles present are lamellar (multilamellar and/or unilamellar). In other embodiments, a minority of the particles present are irregular particles. The only active method step in the instant claim is “adjusting the ratio of at least two of…”, therefore, the different combinations of particles disclosed in paragraph 0090 would necessarily result in an adjustment of density.
Regarding claim 42, in some embodiments surfactants are absent (column 13, lines 36-65).
Regarding claim 43, as noted above, the extract is a hemp extract which is a cannabis extract.
Sloat, therefore, anticipates the rejected claims.
Response to Arguments
Applicant's arguments have been fully considered but they are not persuasive.
Applicant argues:
*claims 1 and 27 have been amended to recite the at least one active agent comprising an unenriched extract, full spectrum extract, or broad spectrum extract”.
As noted above, the CBD is obtained from a full spectrum or a broad spectrum hemp extract.
Claims 1-5, 9, 13-14, 28-29, 31, 38, 40, and 42-43 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kaufman (US 2017/0000744)
Kaufman discloses a phospholipid nanoparticles of cannabinoids (abstract).
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The minimum/maximum percentage of all required components is 13.11% and 100%, respectively therefore, the amount of the carrier (i.e. water) can be 0%-86.89%.
The nanoparticles are used in cannabinoid therapy (paragraphs 0058-0068).
Kaufman does not disclose the active agent cannabinoid extract is enriched with any additional components, therefore, it would be presumed to be unenriched.
Regarding claims 2-4 and 28, as noted above, the active agent is a cannabinoid. They include the phytocannabinoids delta-9-tetrahydrocannabinol (THC), cannabidiol (CBD), cannabinol (CBN) cannabigerol (CBG), cannabigerol (CBG), cannabichromene (CBC), cannabicyclol (CBL), canabivarol (CBV), tetrahydrocannabivarin (THCV), cannabidivarin (CBDV), cannabichromevarin (CBCV), cannabigerol monoethyl ether (CBGM), or the like; or mixtures or combinations thereof (paragraph 0038).
Regarding claim 5, it is noted cannabinoids are small molecules.
Regarding claim 9, the phospholipid includes phosphatidylcholine (paragraph 0035; 0091).
Regarding claim 13, as noted above, the surfactant is not required.
Regarding claims 14, 29 and 40, the solid nanoparticles can be emulsions, liposomes, and polymeric nanoparticles (paragraph 0158).
Regarding claim 31, the term “cannabinoid therapy” in this disclosure refers to the use of cannabinoids to prevent, treat and/or ameliorate and disease and/or pathology that includes and is not limited to Alzheimer Disease, Amyotrophic Lateral Sclerosis (ALS), chronic pain, diabetes mellitus, dystonia, epilepsy, fibromyalgia, gastrointestinal disorders, gliomas, cancer, Hepatitis C, Human Immunodeficiency Virus (HIV) Huntington Disease, hypertension, incontinence, methicillin-resistant Staphyloccus aureus (MRSA), multiple sclerosis, osteoporosis, pruritus, rheumatoid arthritis, sleep apnea and Tourette Syndrome (paragraph 0043).
Regarding claim 38, as noted above, the nanoparticles are containing in a carrier.
Regarding claim 42, as noted above, surfactants can be included in 0-40%.
Regarding claim 43, the cannabinoid is extracted from hempseed/cannabis.
Kaufman, therefore, anticipates the rejected claims.
Response to Arguments
Applicant's arguments have been fully considered but they are not persuasive.
Applicant argues:
*claims 1 and 27 have been amended to recite the at least one active agent comprising an unenriched extract, full spectrum extract, or broad spectrum extract”.
As noted above, Kaufman does not disclose the active agent cannabinoid extract is enriched with any additional components, therefore, it would be presumed to be unenriched.
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, 9, 13-14, 16, 18, 27-31, 38-39, and 40-43 are rejected under 35 U.S.C. 103 as being unpatentable over Sloat et al. (WO 2020/123407).
The teachings of Sloat are discussed above.
Sloat does not explicitly disclose the density of the nanoparticle composition in relation to the density of the liquid formulation.
As noted above, Sloat discloses preparation of compositions having different combinations of particles. It is additionally discloses the different particles can be present in varying amounts within the composition (paragraph 0090-0097).
Regarding claims 16 and 39, in view of the teachings of varying the different particle types in Sloat and the instant specificity teachings in paragraph 0145 the density is modified by adjust the ratio of different nanoparticle types (e.g., liposomes, solid lipid nanoparticles, etc.)), the skilled artisan would be able to optimize the density of the formulation to the specific parameters desired. Applicant is reminded that where the general conditions of the claims are met, burden is shifted to applicant to provide a patentable distinction. Where 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. See In re Aller, 220 F.2d 454 105 USPQ 233,235 (CCPA 1955).
It would have been obvious to one of ordinary skill in the art to have adjusted the ratio of the different particles disclosed to modify the density of the compositions as recited in the instant claims in order to prepare compositions with various density’s in order to create aqueous solutions.
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Kaufman (US 2017/0000744).
The teachings of Kaufman are discussed above. Kaufman discloses in the Examples disclose dissolving the lipid, active agent and surfactants in water.
The process of synthesizing lipid nanoparticles in the present disclosure may include homogenization techniques such as hot high pressure homogenization technique, cold high pressure homogenization technique, melt emulsification ultrasound (ultrasonication) homogenization technique, high shear homogenization and/or ultrasound technique, microemulsion technique, emulsification-solvent evaporation technique, solvent displacement or injection technique, emulsification-solvent diffusion technique, phase inversion technique, film ultrasonication dispersion technique, and multiple emulsion technique (paragraph 0207).
It is additionally discloses the term “ultra sonification” in this disclosure refers methods in the assembly of phospholipid nanoparticles from ultrasound waves in which ultrasonic amplitudes generate intense cavitation alternating high-pressure and low-pressure cycles that disperse and break up particles down to the nanometer scale.
Kaufman teaches all the claimed requirements, but not necessarily in the same embodiment. Together these would provide the method as claimed. The prior art is not anticipatory insofar as these combinations must be selected from various lists/locations in the reference. It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the invention to have made the composition of claim 1 according to the method recited in the instant claims. Since the modifications within the prior art represent nothing more than the predictable use of prior art elements according to their established functions, a prima facie case of obviousness exists. Applicant is directed to MPEP 2141 C which states the person of ordinary skill in the art is a hypothetical person who is presumed to have known the relevant art at the relevant time. Factors that may be considered in determining the level of ordinary skill in the art may include: (1) "type of problems encountered in the art;" (2) "prior art solutions to those problems;" (3) "rapidity with which innovations are made;" (4) "sophistication of the technology; and" (5) "educational level of active workers in the field." In re GPAC, 57 F.3d 1573, 1579, 35 USPQ2d 1116, 1121 (Fed. Cir. 1995). "In a given case, every factor may not be present, and one or more factors may predominate." Id. See also Custom Accessories, Inc. v. Jeffrey-Allan Indust., Inc., 807 F.2d 955, 962, 1 USPQ2d 1196, 1201 (Fed. Cir. 1986); Environmental Designs, Ltd. v. Union Oil Co., 713 F.2d 693, 696, 218 USPQ 865, 868 (Fed. Cir. 1983). "A person of ordinary skill in the art is also a person of ordinary creativity, not an automaton."KSR, 550 U.S. at 421, 82 USPQ2d at 1397. "[I]n many cases a person of ordinary skill will be able to fit the teachings of multiple patents together like pieces of a puzzle."Id. at 420, 82 USPQ2d at 1397.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-5, 9, 13-14, 16, 18-19, 27-31, and 38-41 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of U.S. Patent No. 11,260,033. Although the claims at issue are not identical, they are not patentably distinct from each other because both applications are drawn to lipid based nanoparticles comprising an active agent (CBD), a lipid (phosphatidylcholine, and water. Additional components such as a sterol is additionally disclosed in dependent claims.
Response to Arguments
Applicant's arguments have been fully considered but they are not persuasive. Applicant argues:
*Applicant submits that the arguments regarding patentability over Sloat made above apply to the 033’ Patent and the double patenting rejection is obviated for at least those reasons.
As noted above, the CBD is obtained from a full spectrum or a broad spectrum hemp extract.
Conclusion
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MELISSA S MERCIER whose telephone number is (571)272-9039. The examiner can normally be reached M-F 6:30 am to 4 pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert A Wax can be reached at 571-272-0623. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MELISSA S MERCIER/ Primary Examiner, Art Unit 1615
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