DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA . 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 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.
Status of the Claims
The reply filed 03/04/2026 is acknowledged.
Claims 1-4, 7-8, 10-15, 19-22, and 28-30 are pending.
Claims 28-30 are new.
Claims 1-4, 7-8, and 10-15 remain withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 10/31/2025.
Claims 19-22 and 28-30 are treated on the merits in this action.
The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application. Rejections not reiterated herein have been withdrawn.
Withdrawn
The rejection of claims 19-22 are rejected under 35 U.S.C. 103 as being unpatentable over Shah, US 20210205235 and Nowak, WO 2020016653 A1 has been withdrawn.
Shah, US 20210205235 has been disqualified as prior art under the 35 U.S.C. § 102(b)(2)(C) exception.
The rejection of claims 19-22 are rejected under 35 U.S.C. 103 as being unpatentable over Shah, US 20230065736 and Nowak, WO 2020016653 A1 has been withdrawn.
Shah, US 20230065736 has been disqualified as prior art under the 35 U.S.C. § 102(b)(2)(C) exception.
Response to Arguments
Applicant's arguments filed 03/04/2026 have been fully considered but they are not persuasive. Applicant’s arguments are addressed in as much as the they apply to the new rejections made in response to Applicant’s amendment.
Applicant has argued Nowak fails to teach the percent release of the amended claims. Applicant argues Nowak teaches percent release of one or more cannabinoids, but is silent to a method where 20% or less of the cannabinoid oil is released in the stomach. Applicant argues Friedman fails to teach or suggest the claimed region of the gastrointestinal tract for local delivery of cannabinoids. Applicant argues Friedman merely discloses a method for treating gastrointestinal disease, wherein each dose provides local delivery of the cannabinoids to one or more regions of the gastrointestinal tract, selected from the ilium, jejunum, distal jejunum, and the colon, i.e. locations in the intestines. Applicant argues Friedman is silent as to a method where any cannabinoid oil, let alone 20% or less, is released in the stomach.
This argument is unpersuasive.
Nowak teaches 20% or less release within one hour and 40% or less release in two hours. Noting Nowak does not expressly relate this time frame to the stomach, it was understood that the residence time in the stomach is generally considered as a two-hour time frame from ingestion. For example, Friedman teaches dissolution studies simulating the gastrointestinal tract include a dissolution media compartment with simulated gastric fluid at pH 1.5 with a residence time of two hours, followed by transfer to a dissolution media compartment containing simulated intestinal fluid with a residence time of four hours (Friedman, e.g., example 12, pg. 52). Furthermore, Shah expressly teaches formulating particulate cores containing a volatile active agent oil with an enteric coating such that the cores release less than 20% of the active in the stomach (Shah, e.g., 0062). Shah also relates the multiparticulate show not more than 20% release of the active within about two hours of being placed in simulated gastric fluid, i.e., 0.1N HCl solution, (Shah, e.g., claim 15). Thus, the skilled artisan understood that the claimed range is within the range of not more than 40% release within two hours as related in Nowak because the residence time of the dosage form in the stomach is generally considered to be about two hours, and Shah expressly teaches an enteric coating is designed to release less than 20% of the active in the stomach so that the dose is released in the intestine (Shah, e.g., 0062) due to the fact that that enteric coating does not dissolve in the stomach (Shah, e.g., 0004). Thus, to reduce the number of times Nowak’s dosage forms must be administered in the practice of Nowak’s method for treating central nervous system disorders, the skilled artisan would have been motivated improve Nowak’s dosage forms with delayed release enteric coated particulate cores as suggested by Friedman and Shah so that a single dosage form could deliver at least one additional dose of the cannabinoid oil in the intestine, e.g., the duodenum with a reasonable expectation of success.
Applicant argues Shah 2014 fails to remedy the deficiencies of Nowak and Friedman. Applicant argues Shah 2014 is directed to treating a gastrointestinal disorder with the rapid release of peppermint oil, wherein preferably 20% or less of the peppermint oil is released in the stomach.7 Applicant argues one skilled in the art would recognize that cannabinoid oil and peppermint oil are not interchangeable, as these terms are used to refer to two distinct plants with two distinct chemical compositions. Applicant argues the skilled artisan would have no reasonable expectation of success that the method described in Shah 2014 to target the release of 20% or less of peppermint oil in the stomach could also be used to target the release of 20% or less of cannabinoids in the stomach. Applicant argues Shah 2014 does not disclose or suggest the use of releasing 20% or less of cannabinoid oil in the stomach and therefore does not overcome the deficiencies of Nowak and Friedman. The skilled artisan would not have combined the cited references to arrive at the present claims.
These arguments are unpersuasive.
Applicant acknowledges Shah teaches multiparticulate cores which release 20% or less of the encapsulated peppermint oil in the stomach. However, Applicant argues cannabinoid oil and peppermint oil are not interchangeable because they come from distinct plants. This argument is not persuasive because peppermint oil and cannabinoid oils are both volatile active oils even if they come from distinct plants. Further, Friedman expressly teaches dosage forms for cannabinoids may contain an acid resistant, i.e., enteric, i.e., pH resistant, coating for delayed release in the intestine (Friedman, e.g., claim 15, claim 20, 0023, 0030, and particularly 00127). Shah teaches multiparticulate cores based on microcrystalline cellulose like those of Nowak which are formulated with an acid resistant, i.e., enteric, i.e., pH resistant, coating for insolubility in the stomach resulting in a delayed release - after about a two hour residence time in the stomach – after transiting the lower pylorus of the stomach, e.g., in the intestine, e.g., the duodenum. At least from Friedman, the skilled artisan would have had motivation and a reasonable expectation of successfully applying Shah’s known enteric formulation techniques to improve the practice of Nowak’s method by modifying the dosage forms used in Nowak’s method with multiparticulate microcrystalline cellulose cores containing the cannabinoid oil and an enteric coating to realize Nowak’s goal of relieving the multiple dosing regimen burden on patients for effective treatment of central nervous system disorders with cannabinoids (Nowak, e.g., 0008 and 0010).
Rejections Addressing Applicant’s Amendment
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 20 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 20 includes the limitation the plurality of individual particles comprise spheroidal having an average diameter of 0.5 mm to 1.7 mm. The phrase “comprise spheroidal” is not clear, e.g., it is not clear if the limitation is complete.
Clarification is required.
Claim 28 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 28 includes the limitation of substantially dry. The term “substantially” in claim 28is a relative term which renders the claim indefinite. The term “substantially” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is not clear how dry the cannabinoid oil bound in the microcrystalline cellulose must be to meet the claim limitation. The skilled artisan is not able to reasonably determine the metes and bounds for which Applicant is claiming protection.
Clarification is required.
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 of this title, 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.
Claims 19-22 and 28-30 are rejected under 35 U.S.C. 103 as being unpatentable over Nowak, WO 2020016653 A1 and Friedman, WO 2019159174 A1 (both cited previously) and further in view of Shah, US 20140017325 A1.
Nowak teaches extended-release cannabinoid formulations (Nowak, e.g., Title, Abstract, claims, examples). Nowak teaches formulations containing cannabinoid oil applied to microcrystalline cellulose cores when preparing granules (Nowak, e.g., 0059-0060, i.e., cannabinoid containing drug dispersions applied onto cores of microcrystalline cellulose). This technique enables control over particle size distribution to achieve more uniform drug distribution and targeted delivery profiles (Nowak, e.g., 0060). Nowak teaches extended release to avoid the need for multiple dose administration (Nowak, e.g., 0010-0011). The formulations may offer targeted pharmacokinetic profiles and provide a uniform drug distribution in the gastrointestinal tract (Nowak, e.g., 0002 and 0017). Nowak teaches formulations which are self-emulsifying (Nowak, e.g., 0046). Nowak teaches particle sizes ranging from about 0.03 to about 2 mm (Nowak, e.g., 0036 and claim 20). 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); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). MPEP 2144.05.
Nowak further teaches the cannabinoid dosage forms effective for treating pain, multiple sclerosis, epilepsy, anxiety, depression, schizophrenia (Nowak, e.g., 0008 and 0013 and claims 27-29). Nowak teaches cannabinoids have neuroprotective effect (Nowak, e.g., 0013). Nowak teaches administering the formulations to treat subjects, e.g., orally (Nowak, e.g., 0062-0068, 0024, 0037, claims 27-29). These teachings in Nowak would have prompted the skilled artisan to practice a method comprising administering extended-release cannabinoid compositions to subjects within the scope of claim 19 since at least pain, multiple sclerosis, epilepsy, anxiety, depression, schizophrenia are central nervous system disorders.
Nowak teaches the cores further comprising release controlling polymers and excipients which promote release, e.g., disintegrants (Nowak, e.g., 0038, 0042, 0049, and 0053), but does not expressly teach the cores comprising an enteric coating over the solid core.
Friedman also teaches emulsifying cannabinoid formulations (Friedman, e.g., 0079 and examples). Friedman teaches the composition and dosage forms of their invention enable precise control of the release profile of the cannabinoid and enable targeting the release to specific parts of the gastrointestinal system, e.g., small intestine and/or large intestine (Friedman, e.g., 0010, 0022, 0051, 0138). Friedman teaches enteric coatings protect from decomposition in acidic gastric pH and enables targeted release of cannabinoids in the intestine, e.g., delayed release (Friedman, e.g., 0021-0023 and 0138, 0030, and claim 15 and claim 20). Friedman teaches disintegrants, e.g., croscarmellose sodium or sodium starch glycolate may be added to the solid matrix to avoid incomplete drug release (Friedman, e.g., 00115), and exemplifies cores containing a disintegrant, e.g., crosscarmellose sodium (Friedman, e.g., 0162-0163, and Tables 2-3). Friedman teaches delayed release includes release in the small intestine (Friedman, e.g., 0010), e.g., upon crossing the stomach (Friedman, e.g., 0138). Since the duodenum is in the small intestine after crossing the stomach, the skilled artisan would have understood Friedman teaches delayed release may include targeted release in the duodenum.
It would have been obvious before the effective filing date of the presently claimed invention to modify particulates used in Nowak’s methods by incorporating an enteric coating on cores with a reasonable expectation of success. Since Nowak teaches a need for reducing the number of doses required by the patient, the skilled artisan would have seen this modification as the use of a known technique to improve similar methods in the same way. The skilled artisan would have been motivated to administer dosage forms containing enteric coated pellets for a delayed release dose which is targeted to the small intestine. The skilled artisan would have understood that this delayed release may be useful to provide a delayed dose of cannabinoids with a single administration thereby realizing Nowak’s objective of reducing the number of doses required for therapeutic treatment.
The combined teachings of Nowak and Friedman teach a method for treating central nervous system disorders comprising administering a multiparticulate composition comprising a plurality of individual particles containing a solid core including an effective amount of cannabinoid bound in microcrystalline cellulose and an enteric coating over the core, wherein the dosage form is configured to release in the small intestine (Friedman, e.g., 0010), e.g., upon crossing the stomach (Friedman, e.g., 0138). Nowak further teaches the dosage form may be configured such that less than 40% is released after two hours (Nowak, e.g., 0059). However, the combined teachings of Nowak and Friedman do not expressly teach wherein 20% or less of the cannabinoid is released in the stomach.
Shah teaches similar multiparticulate dosage forms comprising 35-75% microcrystalline cellulose, 2-15% methylcellulose, and an enteric coating (Shah, e.g., claim 9, and 0049), and wherein the enteric coating is present in an amount ranging from about 2-35% (Shah, e.g., 0058), and wherein the enteric coating is sufficient to release the active after 2 hours, and wherein 20% or less of the active is released in the stomach, so that release of the dose occurs, e.g., after the particulates pass through the stomach for delivery to the small intestine and wherein the release is targeted for the duodenum section of the small intestine (Shah, e.g., 0063). Thus, from Shah, the skilled artisan understood the amount of enteric coating may be optimized for release after 2 hours which is within the time frame desired by Nowak, which is after the particles leave the stomach, and which results in the release of a dose of the active after two hours in the duodenum. Shah teaches one of the advantages of dispersing the active in MCC is that it allows excess water to be removed without also removing the active oil, i.e., the core can be processed without substantial loss of the active oil (Shah, e.g., 0042). Further advantages of Shah’s techniques are realized when the particulates are modified with an enteric coating, e.g., improved active stability during storage (Shah, e.g., 0051) and retention of volatile active oils during curing of the enteric coating with heat (Shah, e.g., 0052-0056).
It would have been obvious before the effective filing date of the presently claimed invention to modify methods suggested by Nowak and Friedman using duodenum targeted release taught by Shah with a reasonable expectation of success. Since Friedman teaches delayed release may occur in the small intestine, the skilled artisan would have looked to the prior art for techniques useful to minimize release in the stomach and provide a delayed release dose in the small intestine including the duodenum as reported by Shah. The skilled artisan would have been motivated to apply core preparation techniques known from Shah to prepare multiparticulates for dosage forms to practice Nowak’s method for benefits including higher core loading, active oil retention during core preparation, and 2 hour delayed dosing with a single administration. The skilled artisan would have had a reasonable expectation of success because Shah teaches duodednal targeted release is effective for release about two hours after administration thereby extending the therapeutic window of a single administration with a delayed release of about two hours. The skilled artisan would have understood that this delayed release is useful to achieve a delayed dose of cannabinoids with a single administration thereby realizing Nowak’s objective of reducing the number of doses required for therapeutic treatment of central nervous system disorders.
Applicable to claim 20: The size limitations of the particulate in claim 20 overlap with the size range suggested by Nowak. Nowak teaches particle sizes ranging from about 0.03 to about 2 mm (Nowak, e.g., 0036 and claim 20). Shah teaches cores are spheroidal and not more than 3 mm in diameter (Shah, e.g., 0017). 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); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). MPEP 2144.05.
Nowak teaches the cores further comprising release controlling polymers and excipients which promote release, e.g., disintegrants (Nowak, e.g., 0038, 0042, 0049, and 0053). Friedman teaches disintegrants, e.g., croscarmellose sodium or sodium starch glycolate may be added to the solid matrix to avoid incomplete drug release (Friedman, e.g., 00115), and exemplifies cores containing a disintegrant, e.g., crosscarmellose sodium (Friedman, e.g., 0162-0163, and Tables 2-3).
Both Friedman and Shah teach formulating multiparticulate particles with an enteric coating (Friedman, e.g., 0022 and examples), for delayed release (Friedman, e.g., 0023 and 0127), e.g., after two hours (Shah, e.g., 0088-89 and claim 15), wherein the enteric coating is configured to release most of the active after two hours, e.g., in the duodenum (Shah, e.g., 0063).
It would have been obvious before the effective filing date of the presently claimed invention to combine these prior art features to improve Nowak’s method by configuring the dosage form to have multiparticulates sized in the range of 0.03 to about 2 mm, and which contain an amount of enteric coating effective to retain the cannabinoid in the stomach for release in the intestine, e.g., duodenum, thereby producing the predictable results of formulating the dosage form with a delayed dose to reduce the need for multiple doses: an enteric coating capable of releasing less than 20% of the cannabinoid in the stomach for a delayed dose after 2 hours, ensuring complete release with a disintegrant containing core in combination with the enteric coating, and targeting release to the duodenum since this is the first section of the small intestine which occurs after leaving the stomach after two hours.
Applicable to claim 21: Nowak teaches particle sizes ranging from about 0.03 to about 2 mm (Nowak, e.g., 0036 and claim 20). 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); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). MPEP 2144.05. Nowak teaches the dosage form used in the method comprising particles which are configured to release cannabinoid for at least 6 hours (Nowak, e.g., claim 1). Nowak teaches release which results in drug distribution in the gastrointestinal tract (Nowak, e.g., 0002).
Applicable to claim 22: Nowak teaches formulations containing cannabinoid oil applied to microcrystalline cellulose cores when preparing granules (Nowak, e.g., 0059-0060, i.e., cannabinoid containing drug dispersions applied onto cores of microcrystalline cellulose). Shah teaches wherein the active is dispersed in the MCC matrix which allows drying of the cores without risking substantial loss of the active dispersed in the MCC matrix (Shah, e.g., 0042).
Applicable to claim 28: Nowak teaches the cannabinoid oils applied to MCC and the pellets were dried (Nowak, e.g., 0094). Shah teaches the cores are dried (Shah, e.g., 0020). Shah teaches one of the advantages of dispersing the active in MCC is that it allows excess water to be removed without also removing the active oil, i.e., the core can be processed without substantial loss of the active oil (Shah, e.g., 0042).
Applicable to claim 29: The references do not expressly teach a ratio range for the cannabinoid oil and the microcrystalline cellulose. However, Shah teaches core comprising 15-40wt% active oil and about 35-75wt% microcrystalline cellulose (Shah, e.g., 0049). To take advantage of Shah’s higher loading, active oil retention, and delayed dose release after 2 hours, the skilled artisan would have prepared cannabinoid oil particulate cores using Shah’s techniques for use in Nowak’s method to reduce the administration frequency.
Applicable to claim 30: Shah teaches multiparticulate dosage forms comprising about 15-40% active oil, 35-75% microcrystalline cellulose, 2-15% methylcellulose, and an enteric coating (Shah, e.g., claim 9, and 0049). The enteric coating is present in an amount ranging from about 2-35% (Shah, e.g., 0058) for release after the particles leave the stomach, and to target intestinal release, e.g., in the duodenum (Shah, e.g., 0063). 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); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). MPEP 2144.05.
To take advantage of Shah’s higher loading, active oil retention, and delayed dose release after 2 hours, the skilled artisan would have prepared cannabinoid oil particulate cores using Shah’s techniques for use in Nowak’s method to reduce the administration frequency.
Accordingly, the subject matter of claims 19-22 and 28-30 would have been prima facie obvious before the effective filing date of the presently claimed invention, absent evidence to the contrary.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Nowak, WO 2020016653 A1 and Friedman, WO 2019159174 A1 (both cited previously) as applied to claims 19-22 above and further in view of Shah, US 20140017325 A1.
The combined teachings of Nowak and Friedman enumerated above apply here.
The size limitations of the particulate in claim 20 overlap with the size range suggested by Nowak. Nowak and Friedman teach the cores comprising an enteric coating and further comprising a disintegrant (Friedman, e.g., 00115, 0162-0163, and Tables 2-3). Friedman teaches delayed release includes release in the small intestine (Friedman, e.g., 0010), e.g., upon crossing the stomach (Friedman, e.g., 0138). Since the duodenum is in the small intestine after crossing the stomach, the skilled artisan would have understood Friedman teaches delayed release may include targeted release in the duodenum. However, neither Nowak nor Friedman expressly teach release in the duodenum. To the extent that the skilled artisan, reading Nowak and Friedman, would not have understood the duodenum is in the small intestine after crossing the stomach, Shah cures this defect. Shah teaches multiparticulate enteric coated core formulations like those of Nowak and Friedman (Shah, e.g., Abstract, examples, claims), wherein the formulation is targeted for release in the duodenum, e.g., after the particulates pass through the stomach for delivery to the small intestine, and wherein most of the delivery takes place after about 2 hours in the duodenum (Shah, e.g., 0063).
It would have been obvious before the effective filing date of the presently claimed invention to modify methods suggested by Nowak and Friedman using duodenum targeted release taught by Shah with a reasonable expectation of success. Since Friedman teaches delayed release may occur in the small intestine, the skilled artisan would have looked to the prior art for techniques useful for release in the small intestine including the duodenum as reported by Shah. The skilled artisan would have had a reasonable expectation of success because Shah teaches duodednal targeted release is effective for release about two hours after administration thereby extending the therapeutic window of a single administration with a delayed release of about two hours.
Accordingly, the subject matter of claim 20 would have been prima facie obvious before the effective filing date of the presently claimed invention, absent evidence to the contrary.
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 claims at issue 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); and 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 a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form 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 http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claim(s) 19-22 and 28-30 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim(s) 1-16 of US 11717494 in view of Nowak, WO 2020016653 A1 and Shah, US 20140017325.
Although the claims at issue are not identical, they are not patentably distinct from each other because:
The reference claims are directed to a composition comprising: an oral multiparticulate dosage form including a plurality of individual particulates, wherein the individual particulates are spheroidal and comprise: (a) a solid core including an effective amount of cannabinoid oil bound in microcrystalline cellulose (MCC) in a ratio of the cannabinoid oil to the MCC of 0.5:1 to 1.5:1; and (b) an enteric coating over the solid core, wherein the individual particulates are selected from the group consisting of: (i) the individual particulates have an average diameter of 0.5 mm to 1.7 mm and further comprise an enteric coating material and a disintegrant combination configured for the individual particulates to release at least about 50% of the cannabinoid oil in a subject's duodenum for treating inflammation of the duodenum; (ii) the individual particulates have an average diameter of 0.5 to 1.7 mm and are configured to release at least about 50% of the cannabinoid oil in a subject's jejunum for treating inflammation of the jejunum; and (iii) the individual particulates have an average diameter of 0.5 to 1.7 mm and are configured to release at least about 50% of the cannabinoid oil in a subject's ileum for treating inflammation of the ileum, wherein the individual particulates comprise 10% w/w to 50% w/w of the cannabinoid oil, 40% w/w to 75% w/w of the microcrystalline cellulose, 2% w/w to 10% w/w methyl cellulose, and 2% w/w to 35% w/w of the enteric coating (claim 1).
The reference claims do not expressly teach administering the oral multiparticulate dosage form to treat a central nervous system disorder.
However, Nowak suggests administering cannabinoid dosage forms to subject for treating central nervous system disorders including multiple sclerosis, anxiety, depression, epilepsy, and/or migraines (Nowak, e.g., claims 27-29).
It would have been obvious before the effective filing date of the presently claimed invention to modify the method claimed by the reference patent by administering the dosage form to a subject for treating multiple sclerosis, anxiety, depression, epilepsy, and/or migraines with a reasonable expectation of success. The teachings of Nowak provide an express teaching which would have prompted the skilled artisan to make this modification with a reasonable expectation of success. Since the reference claims suggest the dosage forms effective for treating subjects having inflammation, the skilled artisan would have found it obvious to administer an effective amount the dosage forms for other indications known to be treatable by cannabinoids with a reasonable expectation of success.
The reference claims teach the dosage form is configured to release at least about 50% the cannabinoid oil in the ileum (claim 1). This means the dosage form must release at least less than 50% of the cannabinoid in the stomach since the intestines follow the stomach and since the dose must be retained for release in the intestine. However, the combined teachings of the reference claims and Nowak do not expressly teach wherein the dosage form releases 20% or less of the cannabinoid oil in the stomach. Shah teaches enteric coatings configured to release 20% or less of the encapsulated active oil in the stomach from similar enteric coated microcrystalline cellulose cores, and expressly teaches this for targeting a delayed dose to the subject’s intestines, e.g., duodenum and ileum (Shah, e.g., 0063).
It would have been obvious before the effective filing date of the presently claimed invention to modify a dosage form known from the reference claims for use in Nowak’s method using techniques known Shah for targeting release of similar oils from similar multiparticulate dosage forms with a reasonable expectation of success. Shah provides an express teaching which would have prompted the skilled artisan to formulate the enteric coating so that it is effective to release 20% or less in the stomach to maximize the amount of dose available for release in the intestine with a reasonable expectation of success.
Accordingly, the subject matter of claims 19-22 and 28-30 would have been prima facie obvious before the effective filing date of the presently claimed invention, absent evidence to the contrary.
Claim(s) 19-22 and 28-30 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim(s) 1-17 of US 12186281 in view of Nowak, WO 2020016653 A1 and Shah, US 20140017325.
Although the claims at issue are not identical, they are not patentably distinct from each other because:
The reference claims teach method for preparing an oral pharmaceutical dosage form, the method comprising: wet granulating microcrystalline cellulose and a cannabinoid oil together forming a solid matrix in which the cannabinoid oil is bound in the microcrystalline cellulose; and combining the solid matrix with at least one pharmaceutical excipient to form the oral pharmaceutical dosage form, the oral pharmaceutical dosage form comprising a plurality of individual particulates, wherein the individual particulates are spheroidal and comprise: (a) a solid core including an effective amount of the cannabinoid oil bound in the microcrystalline cellulose (MCC) in a ratio of the cannabinoid oil to the MCC of 0.5:1 to 1.5:1; and (b) an enteric coating over the solid core, wherein the individual particulates are selected from the group consisting of: (i) the individual particulates have an average diameter of 0.5 mm to 1.7 mm and further comprise an enteric coating material and a disintegrant combination configured for the individual particulates to release at least about 50% of the cannabinoid oil in a subject's duodenum for treating inflammation of the duodenum; (ii) the individual particulates have an average diameter of 0.5 to 1.7 mm and are configured to release at least about 50% of the cannabinoid oil in a subject's jejunum for treating inflammation of the jejunum; and (iii) the individual particulates have an average diameter of 0.5 to 1.7 mm and are configured to release at least about 50% of the cannabinoid oil in a subject's ileum for treating inflammation of the ileum, wherein the individual particulates comprise 10% w/w to 50% w/w of the cannabinoid oil, 40% w/w to 75% w/w of the microcrystalline cellulose, 2% w/w to 10% w/w methyl cellulose, and 2% w/w to 35% w/w of the enteric coating.
The reference claims do not expressly teach administering the oral multiparticulate dosage form to treat a central nervous system disorder.
However, Nowak suggests administering cannabinoid dosage forms to subject for treating central nervous system disorders including multiple sclerosis, anxiety, depression, epilepsy, and/or migraines (Nowak, e.g., claim 27-29).
It would have been obvious before the effective filing date of the presently claimed invention to modify the method claimed by the reference patent by administering the dosage form to a subject for treating multiple sclerosis, anxiety, depression, epilepsy, and/or migraines with a reasonable expectation of success. The teachings of Nowak provide an express teaching which would have prompted the skilled artisan to make this modification with a reasonable expectation of success. Since the reference claims suggest the dosage forms effective for treating subjects having inflammation, the skilled artisan would have found it obvious to administer an effective amount the dosage forms for other indications known to be treatable by cannabinoids with a reasonable expectation of success.
The reference claims teach the dosage form is configured to release at least about 50% the cannabinoid oil in the ileum (claim 1). This means the dosage form must release at least less than 50% of the cannabinoid in the stomach since the intestines follow the stomach and since the dose must be retained for release in the intestine. However, the combined teachings of the reference claims and Nowak do not expressly teach wherein the dosage form releases 20% or less of the cannabinoid oil in the stomach. Shah teaches enteric coatings configured to release 20% or less of the encapsulated active oil in the stomach from similar enteric coated microcrystalline cellulose cores, and expressly teaches this for targeting a delayed dose to the subject’s intestines, e.g., duodenum and ileum (Shah, e.g., 0063).
It would have been obvious before the effective filing date of the presently claimed invention to modify a dosage form known from the reference claims for use in Nowak’s method using techniques known Shah for targeting release of similar oils from similar multiparticulate dosage forms with a reasonable expectation of success. Shah provides an express teaching which would have prompted the skilled artisan to formulate the enteric coating so that it is effective to release 20% or less in the stomach to maximize the amount of dose available for release in the intestine with a reasonable expectation of success.
Accordingly, the subject matter of claims 19-22 and 28-30 would have been prima facie obvious before the effective filing date of the presently claimed invention, absent evidence to the contrary.
Conclusion
No claim is allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. 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 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.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WILLIAM A CRAIGO whose telephone number is (571)270-1347. The examiner can normally be reached on Monday - Friday, 9am - 6pm, PDT.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert A WAX can be reached on 571-272-0623. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/WILLIAM CRAIGO/Examiner, Art Unit 1615
/SUSAN T TRAN/Primary Examiner, Art Unit 1615