DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after 16 March 2013, is being examined under the first inventor to file provisions of the AIA .
Status of the Claims
The listing of claims filed 14 November 2025, have been examined. Claims 1-3, 5, 7-11, 13, and 14 are pending. Claims 15-17, 19, 20, 22, 25, 26, and 30 are in groups that were not elected and will not be further considered in this examination. Claims 4, 6, 12, 18, 21, 23, 24, 27-29, and 31-33 are canceled.
In response to the 14 August 2025, Requirement for Restriction/Election, the applicant’s election for examination without traverse of Group I, claims 1-3, 5, 7-11, 13, and 14, and species A9-tetrahydrocannabinol (THC) hydrophobic payload, undecanoic acid (UDA) release agent, calcium sulfate drying agent, octanoic acid (OA) leave-in solvent, Neobee® 1053 sequestering agent, and buccal mode of administration, in the reply filed on 14 November 2025, is acknowledged. Thus, the examination herein is limited to claims 1-3, 5, 7-11, 13, and 14 the relevant elected species.
The election without traverse is therefore made final and cannot be further petitioned under 37 CFR 1.144. Accordingly, claims 15-17, 19, 20, 22, 25, 26, and 30 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a non-elected invention (see also MPEP § 821.03).
Claim Objections
Claims 2, 3, and 8-10 are objected to because of the following informalities:
Claim 2 lacks a period at the end. Correction is required.
Claim 3 recites “a release agent encapsulated within the hollow internal space of the YP along with the hydrophobic payload; or a sequestering agent encapsulated within the hollow internal space of the YP along with the payload.” The first alternative uses “the hydrophobic payload” and the second uses “the payload”. To ensure proper antecedent basis, the applicant is advised to replace “along with the payload” to “along with the hydrophobic payload”.
Claim 8 recites "...wherein the leave-in solvent is selected..." (singular), which depends from claim 2. However, claim 2 introduces "one or more leave-in solvents" (plural). Thus, claim 8 switches to the singular "the leave-in solvent" without previously establishing a single solvent. Claim 8 should be corrected to read "the one or more leave-in solvents are selected..." or Claim 2 should be amended to the singular.
Claims 9 and 10 are objected to because they recite the ungrammatical phrase "a glycerin." Glycerin is a mass noun and cannot be preceded by an indefinite article. The limitation should be corrected to read "glycerin".
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 Applicant regards as his invention.
Claims 9 and 10 are 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, regards as the invention.
Claims 9 and 10 recite proprietary commercial brand names and trademark designations including PLURONIC® 17R4, IGEPAL CO-520, TRITON™ X-100, Brij58, Brij35, CAPMUL®, NEOBEE® 1053, BRIJ®, and PLURONIC®. Trademark terminology does not define the chemical structure of the claimed components. Trademarked and commercial trade names may vary between manufacturers, are subject to change by the manufacturer at any time without public notice, and therefore do not provide a clear structural limitation.
Consequently, the public cannot ascertain the permanent, exact structural and chemical boundaries of the claimed composition over the lifetime of the patent. Thus, the trademark designations do not particularly point out and distinctly define the claimed invention. The applicant is required to amend the claims to replace these proprietary trademarks and trade names with their precise scientific or generic chemical names, formulations, or structural characteristics.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. § 102 and 103 (or as subject to pre-AIA 35 U.S.C. § 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-3 are rejected under 35 U.S.C. § 102(a)(1) as being anticipated by Franklin and Ostroff (US20140170198A1; published 19 June 2014, hereinafter “Franklin”).
Franklin teaches yeast-derived particle delivery systems having a hollow internal cavity suitable for carrying payloads, such as for terpenes (Abstract; ¶[0001]). Franklin describes the yeast cell wall particles and hollow glucan particles produced by removal of intracellular yeast contents as delivery vehicles capable of encapsulating a variety of pharmaceutical agents (¶[0017]-[0021]), and other biologically active agents including terpenes (¶[0042], ¶[0055], ¶[0070], ¶[0071], and claims 81 and 82). The encapsulated terpenes exemplified by Franklin, including L-carvone, citral, thymol, eugenol, and geraniol, or mixtures thereof, are all molecules known for their hydrophobicity (Table 13).
Franklin teaches that compositions comprising a terpene component can be used in suspension or solution in a solvent, suitably the solvent is water (¶[0038]), adjuvant surfactants for suspensions or emulsions (¶[0040] and ¶[0041]), and additionally; adjuvants can be used to increase efficacy (¶[0549]). Franklin teaches wherein, “The surfactant acts to hold the terpene component in an emulsion and also assists encapsulation of the terpene component into the hollow glucan particle or cell wall particle. The surfactant can also act to modify or control the release characteristics of the terpene from the hollow glycan particle or cell wall particle.” (¶[0061]). Thus, a surfactant component can be used as a “sequestering agent” and/or “release agent”. A dispersal agent (“release agent”), such as xanthan gum which promotes dispersal of the composition may also be used (¶[0078]). Adjuvants xanthan and polysorbate and the solvent water are used in an exemplary formulation presented in Table 20. Thus, Franklin teaches all the limitations of instant claims 1-3.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. § 102 and 103 (or as subject to pre-AIA 35 U.S.C. § 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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 and 13 are rejected under 35 U.S.C. § 103 as being unpatentable over Franklin and Ostroff (US20140170198A1; published 19 June 2014, hereinafter “Franklin”).
Franklin teaches the limitations of instant claim 1, as described above, from which instant claim 13 depends, however does not explicitly teach the specific limitations of instant claim 13, wherein the YP delivery system of instant claim 1 is provided as a kit.
Franklin teaches that the yeast particle compositions are useful as delivery systems for hydrophobic active agents and may be formulated into compositions suitable for the medical, veterinary and agricultural fields (Abstract). Franklin teaches oral, parenteral and topical administration (¶[0080]-[0083]), however, does not explicitly teach wherein the YP delivery system is provided as a kit.
However, it would have been prima facie obvious to one of ordinary skill in the art prior to the instant effective filing date of the claimed invention to provide the YP delivery system of Franklin as a kit because packaging compositions, delivery vehicles, and associated excipients or administration components as a kit represents a predictable and routine modification of compositions for product commercialization. One of ordinary skill in the art would have recognized that a commercial pharmaceutical delivery system would commonly be provided with associated components in a kit format to facilitate storage, preparation, and administration.
The modification would have required only the application of a known packaging technique to a known delivery composition and would not have altered the structure or function of the yeast particle delivery system. Modifications involving known components and conventional arrangements are obvious where the skilled artisan would have expected the modification to achieve predictable results (see MPEP §2144).
Further, adding a "kit" limitation to a composition claim fails to impart patentable weight because the physical and chemical properties of the composition remain completely unchanged regardless of whether the composition is sitting by itself or inside a retail box (see In re Ngai, 367 F.3d 1336 (Fed. Cir. 2004)). The only distinction between Franklin and claim 13 is the presentation of the known composition as a kit, which is an obvious matter of packaging and administration. A person of ordinary skill in the art would have had a reasonable expectation of success because the underlying yeast particle delivery system, active ingredient encapsulation, and pharmaceutical formulation components remain unchanged.
Claims 1, 5, 11, and 14 are rejected under 35 U.S.C. § 103 as being unpatentable over Franklin and Ostroff (US20140170198A1; published 19 June 2014, hereinafter “Franklin”) in view of Friedman (US20190298683A1; published 03 October 2019).
Franklin teaches the limitations of instant claim 1, as described above, from which instant claims 5, 11 and 14 depend, however does not explicitly teach the specific limitations of instant claims 5, 11 and 14 including a self-emulsifying delivery system (SEDDS) solvent, THC/cannabinoids as the hydrophobic payload, or the specific pharmaceutical composition containing a pharmaceutically acceptable excipient.
Franklin teaches use of solvents, surfactants, and adjuvants associated with encapsulation of hydrophobic compounds. Specifically, Franklin teaches use of non-aqueous solvents including propylene glycol [1,3- propanediol] (¶[0081]), surfactants to maintain emulsions and improve encapsulation (¶¶[0040]-[0041], [0061]), and adjuvants to improve efficacy (¶[0549]), however does not explicitly teach wherein it is specifically a self-emulsifying delivery system (SEDDS) solvent.
Friedman teaches a self-emulsifying composition comprising a cannabinoid, including tetrahydrocannabinol (THC), and a terpene (claims 49 and 51), that may further comprise about lecithin as an emulsifier (¶[0090]), and triglycerides as a co-solvent (¶[0039]), including medium chain triglycerides (¶[0090]) and ¶[0091]), and propylene glycol [1,3- propanediol] (¶[0091]). Cannabinoids are known hydrophobic compounds that share similar physicochemical properties with terpenes.
In addition, Franklin recites, “ Parenteral administration is generally characterized by injection. For injectables it will be appreciated that, in general, all materials used in the composition and any excipient used must be of pharmaceutical grade.” (¶[0081]). Friedman explicitly teaches the further inclusion of a pharmaceutically acceptable excipient (¶[0015]).
Thus, it would have been prima facie obvious to one of ordinary skill in the art prior to the instant effective filing date of the invention to modify the teachings of Franklin by replacing or supplementing Franklin’s solvent/surfactant system with Friedman’s self-emulsifying solvent system because both references are directed to improving delivery of poorly soluble hydrophobic compounds and add the additional pharmaceutically acceptable excipient and THC hydrophobic agent taught by Friedman to the terpene of Franklin. The motivation to combine would have been to improve dispersion of hydrophobic payloads, bioavailability, formulation stability, and delivery efficiency.
A skilled artisan would have recognized that cannabinoids, terpenes, and similar hydrophobic compounds suffer from poor aqueous solubility and therefore benefit from lipid-based self-emulsifying delivery systems. The combination represents the predictable use of prior art elements according to their established functions (KSR Int'l Co. v. Teleflex Inc., 550 U.S. 416 (2007)). The use of Friedman’s SEDDS components would merely represent selection of known formulation variables to optimize solubilization and delivery. Optimization of known result-effective variables is obvious (see In re Aller, 220 F.2d 454, 456 (CCPA 1955) and In re Peterson, 315 F.3d 1325, 1329 (Fed. Cir. 2003)), wherein a skilled artisan would have reasonably expected success because SEDDS systems were specifically developed to enhance delivery of hydrophobic compounds, and Franklin already teaches incorporation of hydrophobic agents into yeast particles using surfactant/adjuvant systems.
Claims 1 and 7 are rejected under 35 U.S.C. § 103 as being unpatentable over Franklin and Ostroff (US20140170198A1; published 19 June 2014, hereinafter “Franklin”) in view of Finley and Bestwick (US20180344661A1; published 06 December 2018, hereinafter “Finley”).
Franklin teaches the limitations of instant claim 1, as described above, from which instant claim 7 depends, however does not explicitly teach the specific limitation of a drying agent of instant claim 7.
Franklin teaches drying the particles using known drying techniques after encapsulation of active agents (¶[0089]), however does not explicitly teach incorporation of a specific drying agent. The difference between Franklin and instant claim 7 is therefore only the selection of a known drying agent for its known purpose.
Finley teaches cannabis oil compositions (Abstract), that may comprise the active ingredient(s), together with calcium sulfate (¶[0193]), a known drying agent. Further, drying agents are conventional manufacturing additives. A skilled artisan preparing yeast particle compositions would have recognized the need to control moisture, storage stability, and particle aggregation. Selection of calcium sulfate would have been a routine choice from known drying agents.
Thus, it would have been prima facie obvious to one of ordinary skill in the art prior to the instant effective filing date of the invention to incorporate calcium sulfate into Franklin’s yeast particle delivery system because both references address preparation of stable compositions containing hydrophobic active compounds. The motivation to do so would have been to improve moisture control, storage stability, and powder handling characteristics. A skilled artisan would have expected success because calcium sulfate was a known drying agent used in pharmaceutical and nutraceutical formulations. The selection of calcium sulfate represents a routine optimization of a known formulation parameter (see In re Peterson, 315 F.3d 1325, 1329 (Fed. Cir. 2003)).
Claims 1, 2 and 8 are rejected under 35 U.S.C. § 103 as being unpatentable over Franklin and Ostroff (US20140170198A1; published 19 June 2014, hereinafter “Franklin”) in view of Stinchcomb and Banks (US20100273895A1; published 28 October 2010, hereinafter “Stinchcomb”).
Franklin teaches the limitations of instant claims 1 and 2, as described above, from which instant claim 8 depends, and encapsulation of active materials, however does not explicitly teach octanoic acid as the leave-in solvent as required by instant claim 8.
Stinchcomb teaches pharmaceutical compositions comprising cannabidiol or cannabidiol prodrugs, which are administered orally, buccally, or sublingually (¶[0016]) with a penetration enhancers including octanoic acid/caprylic acid (Claim 6, 43, 44, and 46 and ¶[0063]). The references do not specifically disclose “leave-in solvents”, although they both teach inclusion of solubilizing solvents and excipients with hydrophobic compounds, wherein including a compatible solvent within the yeast particle payload mixture to improve loading efficiency and dissolution would have been obvious.
Thus, it would have been prima facie obvious to one of ordinary skill in the art prior to the instant effective filing date to add the octanoic acid taught by Stinchcomb as a solvent to the YP delivery system taught by Franklin because octanoic acid was known to improve delivery of hydrophobic cannabinoids through biological membranes. The motivation to combine is the common goal of improving absorption of poorly soluble compounds. A skilled artisan would have expected success because Franklin already teaches incorporation of hydrophobic compounds with solvents and surfactants, and Stinchcomb confirms octanoic acid’s compatibility with cannabinoid delivery systems.
Claims 1, 3 and 9 are rejected under 35 U.S.C. § 103 as being unpatentable over Franklin and Ostroff (US20140170198A1; published 19 June 2014, hereinafter “Franklin”) in view of Elsohly and Repka (US20060257463A1; published 16 November 2006, hereinafter “Elsohly”).
Franklin teaches the limitations of instant claims 1 and 3, as described above, from which instant claim 9 depends, and the use of surfactants/release-modifying agents but does not expressly teach undecanoic acid as the release agent as required by instant claim 9.
Elsohly teaches a transmucosally delivering a cannabinoid preparation containing the cannabinoid (Abstract), preferably contain a penetration enhancer (which may also be referred to as an absorption enhancer or permeability enhancer) including undecanoic acid, propylene glycol, or glycerin (¶[0016]). The references do not expressly identify a “release agent”. However, a skilled artisan would have recognized that release kinetics and stability are routine formulation considerations. Adding fatty acids, surfactants, or glycerol derivatives would predictably modify dissolution, dispersion and release characteristics (see In re Aller, 220 F.2d 454 (CCPA 1955)). Optimization of conditions and selection of suitable materials for achieving desired properties is obvious absent unexpected results.
Thus, it would have been prima facie obvious to one of ordinary skill in the art prior to the instant effective filing date of the invention to substitute undecanoic acid for or include it with Franklin’s release-modifying agents because undecanoic acid was known to improve transport and delivery of cannabinoid compounds. The modification would have been a predictable selection among known penetration-enhancing excipients that modify release (see MPEP §2144.05).
Claims 1, 3 and 10 are rejected under 35 U.S.C. § 103 as being unpatentable over Franklin and Ostroff (US20140170198A1; published 19 June 2014, hereinafter “Franklin”) in view of Ristevski and Bolton (WO2021046628A1; published 18 March 2021, hereinafter “Ristevski”) and Tian et al. (CN112755006A; published 07 May 2021, hereinafter “Tian”).
Franklin teaches the limitations of instant claims 1 and 3, as described above, from which instant claim 10 depends, and the use of agents affecting encapsulation and release, however, does not explicitly teach NEOBEE® 1053 as a sequestering agent as required by instant claim 10.
Ristevski teaches stable cannabidiol compositions containing lipophilic solvents (e.g. medium chain triglycerides (MCT); Abstract and ¶[0077]). Ristevski specifically identifies NEOBEE® 1053 as a triglyceride-containing formulation component (¶[0064]). In addition, Tian teaches wherein the oil or oil-like material is selected from NEOBEE® in the self-emulsifying system (claim 4) for orally administered cannabidiol film formulations (Abstract). The references do not expressly identify a “sequestering agent.” However, a skilled artisan would have recognized that release kinetics and stability are routine formulation considerations. Adding fatty acids would predictably modify dissolution, dispersion and release characteristics (see In re Aller, 220 F.2d 454 (CCPA 1955)). Optimization of conditions and selection of suitable materials for achieving desired properties is obvious absent unexpected results.
Thus, it would have been prima facie obvious to one of ordinary skill in the art prior to the instant effective filing date of the invention to incorporate NEOBEE® 1053 into Franklin’s yeast particle system because NEOBEE® was a known lipid carrier for hydrophobic cannabinoids. The motivation would have been to improve loading efficiency, dispersion, and bioavailability. The combination is merely the predictable use of a known lipid carrier in another known hydrophobic drug delivery system.
It would be obvious to one of ordinary skill in the art to combine familiar elements according to known methods to achieve predictable results or make a simple substitution of known ingredients to achieve the same predictable functional properties in a composition. One of ordinary skill in the art would have reasonably expected success because Franklin already teaches that surfactants and solvents improve encapsulation of hydrophobic compounds, and Ristevski and Tian confirm compatibility of NEOBEE® with cannabinoid delivery.
In summary, The instant claimed differences represent selection and combination of known formulation components for their known functions, yielding predictable improvements in delivery, stability, and bioavailability.
Claim Rejections – Nonstatutory 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).
Claims 1-3, 11, 13 and 14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, 12, and 13 of US Patent No. 10,638,750 B2. Although the claims at issue are not identical, they are not patentably distinct from each for the reasons outlined below.
US 10,638,750 B2 claims a closely related genus of yeast/glucan particle delivery systems having a hollow cavity encapsulating hydrophobic molecules (terpenes). US 10,638,750 B2 specifically teaches yeast/glucan particles, hollow central cavities, encapsulation of hydrophobic compounds, terpene components, and surfactants associated with hydrophobic payloads. The claimed yeast particle delivery system differs only in the selection of a hydrophobic payload and inclusion of an adjuvant.
Pending claim 1 requires a yeast particle delivery system comprising a YP having a hollow internal space, a hydrophobic payload substantially encapsulated within the hollow internal space, and an adjuvant. US 10,638,750 B2 claim 1 claims a composition comprising a glucan particle or cell wall particle ... encapsulating a terpene component, wherein the particle comprises a hollow central cavity suitable for encapsulating the terpene component. US 10,638,750 B2 is highly similar. The only meaningful differences are the specific hydrophobic payload of THC versus a terpene in US 10,638,750 B2 and adjuvant formulation.
Cannabinoids and terpenes are both hydrophobic natural products, thus, selection of a particular hydrophobic active agent from known classes is obvious (see In re Peterson, 315 F.3d 1325 (Fed. Cir. 2003)), as are conventional formulation additives or a kit (see KSR v. Teleflex, 550 U.S. 398 (2007)). Selecting THC as the hydrophobic payload would have been an obvious substitution because cannabinoids are known hydrophobic biologically active compounds suitable for encapsulation within lipid-compatible delivery systems. Adding conventional formulation components such as solvents, surfactants, and excipients would have been an obvious modification because such components are routinely used to improve loading, stability, and delivery of hydrophobic compounds.
Instant claim 2 requires a leave-in solvents encapsulated within the hollow internal space. US 10,638,750 B2 teaches terpene associated with surfactants in liquid formulations. Instant claim 3 requires a release agent or sequestering agent encapsulated with hydrophobic payload. US 10,638,750 B2 claim 12 teaches a terpene component associated with a surfactant. A surfactant associated with the terpene is analogous to a release agent or sequestration/stabilization agent.
Instant claim 14 requires a pharmaceutical composition with an acceptable excipient. US10638750B2 claim 14 teaches composition further comprising antimicrobial, insecticidal, anti-inflammatory agent, or anesthetic.
Thus, it would have been obvious to modify the particulate delivery system of US 10,638,750 B2 to include a hydrophobic payload and conventional pharmaceutical adjuvants because such modifications merely involve selection of known active agents and formulation components for their established purposes. A person of ordinary skill would have expected success because US 10,638,750 B2 already teaches yeast particles as delivery vehicles for active agents.
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 (see MPEP § 717.02, § 2146, § 2159). A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
A complete reply to a nonstatutory double patenting rejection requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action (see MPEP § 804, 706.07(e) and 714.13; 37 CFR 1.111(a) or (c)). The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. A web-based eTerminal Disclaimer may be filled out online. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-3, 10, 13 and 14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, and 9-12 of US Patent No. 9,682,135 B2. Although the claims at issue are not identical, they are not patentably distinct from each for the reasons outlined below.
US 9,682,135 B2 claim 1 claims a closely related genus of yeast/glucan particle delivery systems having a hollow cavity encapsulating small organic molecules, claim 9 describes a kit and claim 10 wherein it is a pharmaceutical composition comprising a pharmaceutically acceptable excipient. Claim 11 adds wherein the payload molecule and the payload trapping molecule are soluble in the same solvent system and claim 12 wherein the payload trapping molecule stabilizes the association of the payload molecule and is present in an amount sufficient to facilitate retention of the payload molecule within the yeast cell wall. Further, the specification details that suitable aqueous and nonaqueous carriers, diluents, solvents, or vehicles include water, polyols (propylene glycol, polyethylene glycol glycerol, and the like), and triglycerides, including vegetable oils such as olive oil may be used. Thus, instant claims 1-3, 10, 13, and 14 are taught by US 9,682,135 B2.
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 (see MPEP § 717.02, § 2146, § 2159). A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
A complete reply to a nonstatutory double patenting rejection requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action (see MPEP § 804, 706.07(e) and 714.13; 37 CFR 1.111(a) or (c)). The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. A web-based eTerminal Disclaimer may be filled out online. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-3, 10, 13 and 14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 19, 20 and 9-12 of US Patent No. 7,740,861 B2. Although the claims at issue are not identical, they are not patentably distinct from each for the reasons outlined below.
US 7,740,861 B2 claims 1-13 and 19 claims a closely related genus of yeast/glucan particle delivery systems having a hollow cavity encapsulating small organic molecules and a payload trapping molecule, claim 20 describes a kit and claim 21, wherein it is a pharmaceutical composition with a pharmaceutically acceptable excipient. The specification of US 7,740,861 B2 details that suitable aqueous and nonaqueous carriers, diluents, solvents, or vehicles include water, polyols (propylene glycol, polyethylene glycol glycerol, and the like), and triglycerides, including vegetable oils such as olive oil. Thus, US 7,740,861 B2 teaches the limitations of instant claims 1-3, 10, 13 and 14.
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 (see MPEP § 717.02, § 2146, § 2159). A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
A complete reply to a nonstatutory double patenting rejection requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action (see MPEP § 804, 706.07(e) and 714.13; 37 CFR 1.111(a) or (c)). The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. A web-based eTerminal Disclaimer may be filled out online. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-3, 10, 11, 13, and 14 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 11-12, 14, 35, and 36 of co-pending Application No. 18/202,573 (published as US20230413823A1). Although the claims at issue are not identical, they are not patentably distinct from each other for the reasons outlined below. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Co-pending application 18/202,573 claim 1 teaches a particulate delivery system, comprising an extracted yeast cell wall and a pro-payload molecule, wherein the pro-payload molecule comprises a payload molecule operably linked to a payload scaffolding molecule through a chemical linker (release agent or a sequestering agent). Claims 11-12, 14, and 36 claims wherein the payload molecule may be a small organic active agent, a terpene, a terpenoid, a tetrahydrocannabinol, a cannabidiol, or a mixture thereof, tetrahydrocannabinol, or cannabidiol. Claim 35 claims a kit and claim 36 wherein it is a pharmaceutical composition with a pharmaceutically acceptable excipient.
The specification of co-pending application 18/202,573 further teaches loading hydrophobic payloads into the yeast particles together with solvents and surfactants in the specification and specifies that suitable aqueous and nonaqueous carriers, diluents, solvents, or vehicles include water, polyols, e.g., propylene glycol, polyethylene glycol, and glycerol, and triglycerides, including vegetable oils such as olive oil (¶[0210]).
The co-pending application teaches yeast particles, hydrophobic payloads, cannabinoid payloads, encapsulation, leave-in solvents, surfactants, pharmaceutical compositions, and kits. Thus, instant claims 1-3, 10, 11, 13, and 14 are taught by co-pending application 18/202,573. The differences represent routine optimization of payload loading, excipient selection, and formulation components.
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 (see MPEP § 717.02, § 2146, § 2159). A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
A complete reply to a nonstatutory double patenting rejection requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action (see MPEP § 804, 706.07(e) and 714.13; 37 CFR 1.111(a) or (c)). The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. A web-based eTerminal Disclaimer may be filled out online. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to REBECCA L. SCOTLAND whose telephone number is (571) 272-2979. The examiner can normally be reached M-F 9:00 am to 5:00 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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/RL Scotland/
Examiner, Art Unit 1615
/Robert A Wax/Supervisory Patent Examiner, Art Unit 1615
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