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 .
Receipt is acknowledged of Amendments and Remarks filed on 03/30/26. Claims 1, 6, 14, 20 and 36 have been amended, claims 18, 35 and 38 have been canceled and new claims 58-59 have been added. Accordingly, claims 1-4, 6, 14-15, 20-21, 23, 25, 28-29, 31, 36-37, 40 and 58-59 are pending and under examination on the merits.
Rejections and/or objections not reiterated from the previous Office Action are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set of rejections and/or objections presently being applied to the instant application.
Claim objection
Claim 23 recites “… the pharmaceutical acceptable salt…”. It appears this is a typographical error and should be changed to pharmaceutically acceptable salt.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-4, 6, 14-15, 20-21, 23, 25, 28-29, 31, 36-37, 40 and 58-59 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claims 1 and 58-59 recite that the dry powder formulation is contained within an inhaler unit, a diffuser or a nebulizer. However, there is no evidence that a dry powder can be delivered via a nebulizer or a diffuser. The art states that a nebulizer turns a liquid medication into a fine mist. The Specification dose not provide any support for a dry powder being contained in a nebulizer or delivered via a nebulizer.
The Specification states “In some embodiments, administering can comprise inhalation and the inhalation can comprise inhalation by a diffuser, an inhaler, a nebulizer, or any combination thereof. In some embodiments, administering can comprise inhalation and the inhalation can comprise inhalation by a diffuser. In some embodiments, administering can comprise inhalation and the inhalation can comprise inhalation by a nebulizer” (See [0126] of the published Spec).
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.
Claims 1-4, 6, 14-15, 20-21, 23, 25, 28-29, 31, 36-37, 40 and 58-59 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 (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 1 recites the broad recitation an inhaler unit, and the claim also recites a diffuser or a nebulizer which are the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
All other claims depend from rejected claim 1.
Applicant’s claims,
Claim 1 is the broadest claim and is drawn to: A powdery pharmaceutical composition, comprising: i) particles of a pharmaceutically acceptable excipient; and ii) a plurality of spray dried particles, comprising a cannabinoid or a pharmaceutically acceptable salt thereof substantially encapsulated in a coating material, at least a portion thereof having a particle diameter ranging from about 1 micrometer to about 10 micrometer, as measured by a particle analyzer using laser diffraction, wherein the coating material comprises a hydroxypropyl methylcellulose (HPMC), a hydroxypropyl methylcellulose acetate succinate (HPMCAS), a cyclodextrin, a maltodextrin, a povidone, a copovidone or any combination thereof and wherein the powdery pharmaceutical composition is inhalable and is contained within a diffuser, an inhaler unit or a nebulizer.
Claim 36 is drawn to a method of treating a disease or condition.
Claim interpretation:
Specification defines “substantially encapsuled” as a qualitative condition that exhibits an entire or nearly total range or degree of a feature or characteristic of interest. In some cases, substantially may refer to at least about: 70%, ….. 99%, or 100% of the total range or degree of a feature or characteristic of interest.
The term “spray-dried particles” is a product-by process limitation.
Claims 15, 20-21 and 28 list a number of species, but the claims do not use the Markush type language and use the term “comprising” which does not limit the excipient or carbohydrate to those listed.
Limitations such as “contained within a capsule”, “contained in an inhaler unit”, “contained in a nebulizer” or “contained in a diffuser” are only relevant to the storage of the claimed powder formulation (after it has been produced) and do not materially affect the scope of the composition or claim 1.
The Specification does not provide a definition for diffuser. The art recognizes that any device that defuses a material is a diffuser and the Specification states that the formulation is inhaled via a diffuser. Thus, any inhaler reads on a diffuser.
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.
Claims 1-4, 6, 14-15, 20-21, 23, 25, 28-29, 31, 36-37, 40 and 58-59 are rejected under 35 U.S.C. 103 as being unpatentable over Wilkhu et al (11,160,757) in view of Temtsin-Krayz (WO 2019038756 or US 20200368156) (citations from the US document) and DeHaan et al (US 20150136130).
Wilkhu et al teach pH dependent release coated microparticle cannabinoid formulation.
Regarding the powdery composition comprising a plurality of spray dried particles comprising a cannabinoid and an excipient, of claim 1, Wilkhu et al teach a composition that can be in a form of powder comprising coated microparticles of one or more cannabinoid, and wherein the composition comprises excipients (See Col. 6, lines 50-53 and claim 9). Wilkhu et al teach a method of preparing the said microparticulate cannabinoid containing formulation comprising spray drying the formulation (See Col. 3, lines 64-67 and Example 3).
Regarding the coating material of claim 1, Wilkhu et al teach that the pH dependent release polymer is selected from the group consisting of: hydroxypropyl methyl cellulose acetate succinate (HPMCAS), hydroxypropyl methyl cellulose phthalate (HPMCP), polyvinyl acetate phthalate (PVAP), shellac, etc, (See Col. 2, lines 53-67 and claim 4).
Regarding claims 3 and 6, it is disclosed that the said microparticulates may be formulated in any suitable formulation, including a powder, a solid powder filled capsule, (i.e. a unit dose), etc, (See col. 6, lines 53-60, paragraph bridging columns 22-23 and Col. 32, lines 42-50).
The said formulations may be administered in the form of inhalation (See Col. 26, lines 36-41).
Regarding claims 20 and 21, it is disclosed that the said excipients include carriers, diluents and fillers such as lactose, starch, cellulose, dextrin, etc. The said lactose may be lactose monohydrate or lactose anhydrous (See Col. 24, line 16 to col. 25, line 12).
Regarding claims 25 and 28-29, it is disclosed that the said formulation comprises a microparticulate comprising one or more cannabinoids, and one or more pharmaceutically acceptable excipients. The cannabinoid is selected from the group consisting of: cannabichromene (CBC), cannabidiol (CBD), cannabidivarin (CBDV), cannabigerol (CBG), tetrahydrocannabinol (THC), etc, (See Col. 7, lines 18-40). In a preferred embodiment, the formulation comprises at least two cannabinoids, selected from the group consisting of, cannabidiol (CBD), tetrahydrocannabinol (THC), cannabigerol (CBG) etc, (See Col. 7, lines 53-57).
Regarding claim 36, it is disclosed that the said microparticles comprising cannabinoid are administered to a subject in need of treatment for convulsion, seizure, epilepsy, anxiety, neuropathic pain, schizophrenia, etc, (See Col. 3, lines 50-67 and Col. 29, lines 4-25). The said formulations may be administered in the form of inhalation (See Col. 26, lines 36-41).
The examined claims differ from the teachings of Wilkhu et al in that while inhalation is disclosed as a method of administration, the specifics of inhalation are not disclosed, such as particle diameter of the active agent or the excipient, the inhaler, or the amount. These are known in the art as taught by Temtsin-Krayz and DeHaan et al.
Temtsin-Krayz teaches a pharmaceutical composition in a form of dry powder for intranasal administration, comprising solid particles of at least one active agent and solid particles of a diluent, said pharmaceutical composition being substantially free of excipients other than the solid diluent, wherein said pharmaceutical composition having at least 90% of the particles of said at least one active agent with a mean particle size of 10 micron to 30 microns and the particles of said diluent have a mean particle size of 30-200 microns. The said formulation prepared by spray drying method to prepare the said dry powder (See abstract).
Further, regarding claims 1 and 3, it is disclosed that the active agent may be cannabis active compound (See [0018], [0093], [0109] and claim 4), the particles are spray dried and that the powders may be powder microspheres, coated powder microspheres, liposomal dispersions and combinations thereof (See [0034] and [0100]).
Regarding claims 1 and 20-21, Temtsin-Krayz teaches that the said solid diluent is selected from lactose monohydrate or a lactose monohydrate functional analogue, such as lactose, cellulose and derivatives, starch and derivatives, sorbitol, mannitol, maltitol, xylitol or mixtures thereof, preferred solid diluent being lactose monohydrate (See [0035] and [0095]).
Regarding claim 2, Temtsin-Krayz teach that the formulations are administered via a nasal spray or inhaler device (See [0102]-[0103]).
Regarding the dosing frequency in claim 37, a method of treatment is disclosed wherein the therapeutically effective dose of at least one active agent is administered once daily (See [0106]).
Regarding claim 4, Temtsin-Krayz teach that the particle size range of the solid diluent is from 30 to 200 microns, or 50-200 microns (See Abstract, [0016], [0043], [0050], claims 2 and 6-7).
DeHaan et al teach dry powders that contain a therapeutic agent. The dry powders have characteristics, e.g., they are processable and/or dense in therapeutic agent that provide advantages for formulating and delivering therapeutic agents to patients (See abstract).
Regarding claims 1, 23 and 28, DeHaan et al disclose that the said therapeutic agent may be tetrahydrocannabinol (THC or Δ9-THC), cannabidiol (CBD), cannabichromene (CBC), cannabigerol (CBG), cannabiniol (CBN), tec (See [0146]).
Regarding the particle diameter of claims 1 and 31, DeHaan et al teach that the mass of powder has an aerodynamic diameter of less than about 5 microns or 4.4 micrometers, and is representative of the mass which deposits in the lung, and a volume median geometric diameter emitted from the inhaler of 10 microns or less (See [0021], [0034], [0046]-[0047] and claim 49).
Regarding claims 2 and 6, DeHaan et al teach a device (inhaler) comprising one or more receptacles that contain a powder formulation and are sealed. The respirable dry powder is filled or deposited into receptacles using standard filling equipment. The receptacle may be a single dose or multi-dose capsule or cartridge contained in a dry powder inhaler (See [0013] and claim 49).
Regarding claim 15, DeHaan et al teach that preferably, the receptacle is a size 2 or a size 3 capsule (See [0018]).
Regarding claim 14, it is disclosed that the “Capsules are solid dosage forms in which the drug is enclosed within either a hard or soft soluble container or “shell.” The shells are usually formed from gelatin; however, they also may be made from starch, such as hydroxypropyl methylcellulose (HPMC), or other suitable substances” (See [0279]).
Regarding claims 23 and 40, it is disclosed that the respirable dry powders consisting of respirable dry particles can be deposited into receptacles to provide a total dry powder mass of between about 5 mg to about 15 mg, the total content of therapeutic agent or agents in the respirable dry powder is at least 20%, at least 25%, at least 35%, at least 50%, at least 65%, or at least 80% by weight (i.e., dry weight relative to the total dry weight of dry powder) (See [0010]-[0012]). (That is 50% of 15 mg is 7.5 mg and 80% of 5 mg is 4 mg, which meet the claimed amount of 1 to 10 mg).
It would have been prima facie obvious to a person of ordinary skilled in the art at the time the invention was made to have combined the teachings of Temtsin-Krayz and DeHaan et al with that of Wilkhu et al to arrive at the instant invention. It would have been obvious to do so because Wilkhu et al teach a powdery composition comprising one or more cannabinoids and a suitable excipient for administration wherein the administration may be by inhalation. Wilkhu et al also teach that the formulation comprises coated microparticles comprising the cannabinoid for optimum delivery and that the coating material provides for a pH dependent release of the active agent. Wilkhu et al however is silent with regard to the particle sizes, inhalers, amounts of cannabinoid for inhalation or capsules. Thus, one of ordinary skill in the art is motivated to look for these specifics to ensure an effective inhalation delivery of the formulations. Temtsin-Krayz teaches a dry powder formulation comprising cannabis compounds and one or more suitable excipients and teaches that the said particles may be in the form of coated microparticles. Temtsin-Krayz provides guidance for particle size range for the active agent and excipients and that the inhaler may comprise such formulations in a capsule. DeHaan et al also disclose powder formulations comprising cannabinoids which are stored and delivered form a unit dose receptacle including a capsule and provide further guidance on the particle size, the amounts, capsule size and material. Thus, one of ordinary skill in the art wishing to follow Wilkhu et al’s teachings to make coated particles for inhalation would need to look in the art for suggestions on the inhaler, unit dose (receptacle) and their specifics for optimum delivery of a powdery formulation comprising cannabinoids to the subject for treating a condition such as seizures, pain, etc. The person of ordinary skill in the art would find such suggestion in the teachings of Tamtsin-krayz and DeHaan et al as they teach the limitations regarding inhalable particles and devices.
That is, the claims would have been obvious because a person of ordinary skill has good reasons to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely the product not of innovation but of ordinary skill and common sense.
Therefore, the combination of references would have led one of ordinary skill in the art to the same formulation and method as claimed with a reasonable expectation of success.
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 1-4, 6, 14-15, 20-21, 23, 25, 28-29, 31, 36-37, 40 and 58-59 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 4-9, 20-23, 26-29, 34-37 of copending Application No. 18/561,351 (US 20240261227) in view of Tamtsin-Krayz (WO 2019038756 or US 20200368156) and DeHaan et al (US 20150136130).
The Obviousness Double Patenting rejection is appropriate because while the conflicting claims are not identical, the examined claims are not patentably distinct from the reference claims and would have been obvious over the reference claims in view of Tamtsin-Krayz and DeHaan et al.
The examined claims are delineated above.
The reference claims are also directed to a powdery pharmaceutical composition, comprising: i) particles of a pharmaceutically acceptable excipient; and ii) a plurality of spray dried particles, each particle of the plurality of spray dried particles comprising: an epinephrine or a pharmaceutically acceptable salt thereof substantially encapsulated in a coating material, wherein: within the plurality of spray dried particles at least a portion of the spray dried particles comprising the epinephrine or the pharmaceutically acceptable salt thereof substantially encapsulated in the coating material, individually have a particle diameter of about 30 micrometers, as measured by a particle analyzer using laser diffraction and, the coating material comprises a hydroxypropyl methylcellulose (HPMC), a hydroxypropyl methylcellulose acetate succinate (HPMCAS), a povidone, a copovidone or any combination thereof.
The differences between the recited claims of the instant application and the recited claims of copending Application are 1) the active agent and 2) the particle diameter. That is, the instant application claims are directed to a composition comprising a cannabinoid while the reference claims recite an epinephrine. Also, the particle diameter of the instant claimed composition is from about 1 to 10 micrometers while the reference claims recite a diameter of about 30 micrometers.
However, the examined claims would have been obvious over the reference claims in view of the knowledge available to one of ordinary skill in the art, especially Tamtsin-Krayz. Tamtsin-Krayz teach a powdery formulation comprising an active agent and suitable excipients wherein the active agent may be epinephrine, a cannabinoid (cannabis active compounds), etc. It is further recited that the particle diameter may be from 10-30 micrometer. DeHaan et al also teach powder formulations of inhalation and teach that the suitable particle diameter for inhalation to the lung is less than 5 microns. Thus, the combination of references fully advises one of ordinary skill in the art as to the suitable particle size range for pulmonary and nasal administration.
Thus, it is held that the recited claims of the instant application are not mutually exclusive of the reference claims in view of the knowledge available to one of ordinary skill in the art and especially in view of Tamtsin-Krayz and DeHaan et al.
This is a provisional nonstatutory double patenting rejection.
Claims 1-4, 6, 14-15, 20-21, 23, 25, 28-29, 31, 36-37, 40 and 58-59 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 6, 24-25, 27-28, 31-34, 36-37, 41 and 45 of copending Application No. 18/027,655 (US 20230372345) in view of Tamtsin-Krayz (WO 2019038756 or US 20200368156).
The Obviousness Double Patenting rejection is appropriate because while the conflicting claims are not identical, the examined claims are not patentably distinct from the reference claims and would have been obvious over the reference claims in view of Tamtsin-Krayz.
The examined claims are delineated above.
The reference claims are also directed to an inhalable powdery pharmaceutical composition, comprising: i) particles of a pharmaceutically acceptable excipient comprising a lactose or a pharmaceutically acceptable salt thereof, which have an average particle diameter ranging from about 60 micrometers to about 80 micrometers, as measured by a particle analyzer using laser diffraction; and ii) a plurality of spray dried particles, each particle of the plurality of spray dried particles comprising sildenafil, an ester thereof, or a pharmaceutically acceptable salt thereof, substantially encapsulated in a coating material, wherein within the plurality of spray dried particles at least a portion of the spray dried particles comprising the sildenafil, the ester thereof, or the pharmaceutically acceptable salt thereof, substantially encapsulated in the coating material, individually have a particle diameter ranging from about 1 micrometer to about 10 micrometers, as measured by a particle analyzer using laser diffraction and, the coating material comprises a hydroxypropyl methylcellulose acetate succinate (HPMCAS),
The difference between the recited claims of the instant application and the recited claims of copending Application is the active agent. That is, the instant application claims are directed to a composition comprising cannabinoid while the reference claims recite sildenafil.
However, the examined claims would have been obvious over the reference claims in view of the knowledge available to one of ordinary skill in the art, especially Tamtsin-Krayz. Tamtsin-Krayz teach a powdery formulation comprising an active agent and suitable excipients wherein the active agent may be cannabis compounds, sildenafil, etc. Thus, the combination of references fully advises one of ordinary skill in the art as to the same powder formulation comprising either cannabinoids or sildenafil, or other active agents for pulmonary administration.
Thus, it is held that the recited claims of the instant application are not mutually exclusive of the reference claims in view of the knowledge available to one of ordinary skill in the art and especially in view of Tamtsin-Krayz.
This is a provisional nonstatutory double patenting rejection.
Claims 1-4, 6, 14-15, 20-21, 23, 25, 28-29, 31, 36-37, 40 and 58-59 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8, 10-14, 16, 29-30, 32, 36, 44, 48-49 of copending Application No. 18/265,464 (US 20240041782) in view of DeHaan et al (US 20150136130).
The Obviousness Double Patenting rejection is appropriate because while the conflicting claims are not identical, the examined claims are not patentably distinct from the reference claims and would have been obvious over the reference claims in view of DeHaan et al.
The examined claims are delineated above.
The reference claims are also directed to a pharmaceutical or dietary supplement composition, in unit dose form, comprising: a first active ingredient or a pharmaceutically acceptable salt thereof comprising a plurality of spray dried particles, each particle of the plurality of spray dried particles comprising a cannabinoid or a pharmaceutically acceptable salt thereof, substantially encapsulated in a coating material; wherein within the plurality of spray dried particles the plurality of spray dried particles individually have a particle diameter ranging from about 50 micrometers to about 150 micrometers, as measured by a particle analyzer using laser diffraction; wherein the coating material comprises a hydroxypropyl methylcellulose (HPMC), a hydroxypropyl, methylcellulose acetate succinate (HPMCAS), a maltodextrin, a povidone, a copovidone or any combination thereof; and wherein the plurality of spray dried particles are at least partially surrounded by a first capsule and a second capsule, and wherein the first capsule is surrounded by the second capsule.
The differences between the recited claims of the instant application and the recited claims of copending Application are 1) the particle size and 2) the capsules. That is, the instant application claims are directed to a composition comprising cannabinoid in a particle size range of from 1 to 10 micron, while the reference claims recite particle size range of from 50-150 micrometer. Also, the reference claims recite that the particles are at least partially surrounded by a first capsule and a second capsule, a limitation not expressly recited in the examined claims.
However, the examined claims would have been obvious over the reference claims in view of the knowledge available to one of ordinary skill in the art, especially DeHaan et al. DeHaan et al teach a powdery formulation comprising an active agent and suitable excipients wherein the active agent may be a cannabinoid and wherein the particle size range is less than 5 microns. Thus, it would be obvious to select a different particle size range for different routes of administration. Regarding the first and second capsule, it is noted that while the examined claims do not expressly recite this limitation, they do encompass it. It is further noted that both examined claims and reference claims recite that the coating material may be a combination of components and since the claims are drawn to an encapsulated particle, the capsule can be interpreted as referring to the encapsulation.
Thus, it is held that the recited claims of the instant application are not mutually exclusive of the reference claims in view of the knowledge available to one of ordinary skill in the art and especially in view of DeHaan et al.
This is a provisional nonstatutory double patenting rejection.
Claims 1-4, 6, 14-15, 20-21, 23, 25, 28-29, 31, 36-37, 40 and 58-59 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of copending Application No. 19/252,506 (US 20260053751) in view of DeHaan et al (US 20150136130).
The Obviousness Double Patenting rejection is appropriate because while the conflicting claims are not identical, the examined claims are not patentably distinct from the reference claims and would have been obvious over the reference claims in view of DeHaan et al.
The examined claims are delineated above.
The reference claims are also directed to a powdery composition, comprising: a) a plurality of encapsulated spray dried particles, wherein each particle of the plurality of spray dried particles is substantially encapsulated by a first coating, wherein the first coating is substantially encapsulated by one or more additional coatings; and b) wherein the plurality of encapsulated spray dried particles comprise a cannabinoid or a pharmaceutically acceptable salt thereof, wherein within the plurality of encapsulated spray dried particles, the plurality of encapsulated spray dried particles individually have a particle diameter ranging from about 20 micrometers to about 200 micrometers, or have a mean or median particle diameter of about 20 micrometers to about 200 micrometers, as measured by a particle analyzer using laser diffraction, i) wherein the first coating comprises a hydroxypropyl methylcellulose (HPMC), a hydroxypropyl methylcellulose acetate succinate (HPMCAS), a cyclodextrin, a maltodextrin, a povidone, a copovidone or any combination thereof; and ii) wherein the one or more additional coatings comprise an enteric coating.
The differences between the recited claims of the instant application and the recited claims of copending Application are 1) the particle size and 2) the capsules. That is, the instant application claims are directed to a composition comprising cannabinoid in a particle size range of from 1 to 10 micron, while the reference claims recite particle size range of from 20-200 micrometer. Also, the reference claims recite that the particles are at least partially surrounded by a first capsule and a second capsule, a limitation not expressly recited in the examined claims.
However, the examined claims would have been obvious over the reference claims in view of the knowledge available to one of ordinary skill in the art, especially DeHaan et al. DeHaan et al teach a powdery formulation comprising an active agent and suitable excipients wherein the active agent may be a cannabinoid and wherein the particle size range is less than 5 microns. Thus, it would be obvious to select a different particle size range for different routes of administration. Regarding the first and second capsule, it is noted that while the examined claims do not expressly recite this limitation, they do encompass it. It is further noted that both examined claims and reference claims recite that the coating material may be a combination of components and since the claims are drawn to an encapsulated particle, the capsule can be interpreted as referring to the encapsulation.
Thus, it is held that the recited claims of the instant application are not mutually exclusive of the reference claims in view of the knowledge available to one of ordinary skill in the art and especially in view of DeHaan et al.
This is a provisional nonstatutory double patenting rejection.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Appel et al (US 20090142404).
Appel et al teach a dosage form comprising a low-solubility drug, and a precipitation-inhibiting polymer. The drug is in a solubility-improved form and in the form of particles at least partially coated with the precipitation-inhibiting polymer including HPMCAS (See abstract).
Exemplary coating polymers include hydroxypropyl methyl cellulose acetate succinate (HPMCAS), hydroxypropyl methyl cellulose phthalate (HPMCP), hydroxypropyl methyl cellulose acetate, hydroxypropyl methyl cellulose, hydroxypropyl cellulose, methyl cellulose, hydroxyethyl methyl cellulose, hydroxyethyl cellulose acetate, and hydroxyethyl ethyl cellulose (See [0058], [0061], [0065]-[0066]).
Appel et al teach that one method to reduce particle size is by melting or spray drying to form a powder (See [0033], [0078]-[0079] and claim 12).
Appel et al further disclose that the said formulations may comprise additives including fillers, or diluents include lactose, mannitol, xylitol, dextrose, sucrose, sorbitol, microcrystalline cellulose, powdered cellulose, starch, hydroxypropyl methyl cellulose, crospovidone (polyvinylpolypyrrolidone), sodium alginate, etc, (See [0089]-[0091]).
Response to Arguments
Applicant's arguments filed 03/30/26 have been fully considered but they are not persuasive. Applicant’s amendments to the claims have necessitated modified grounds of rejections. Applicant’s arguments so far as they pertain to the maintained references and rejections are discussed below.
Applicant’s first argument is that “the obviousness rejection over Wilkhu, Temtsin-Krayz and DeHann is traversed and should be reconsidered and withdrawn for essentially the same reasons - one of ordinary skill in the art looking to improve or modify Wilkhu (oral administration) would not look to either Temtsin-Krayz or DeHann (intranasal inhalation) for suggestion, direction, or guidance, as the several references are drawn to different and distinct arts, i.e., they are non- analogous” (See Remarks, pages 6-7).
The above argument is neither persuasive nor sufficient to overcome the rejection. A reference is good not only for what it teaches by direct anticipation but also for what one of ordinary skill in the art might reasonably infer from the teachings. (In re Opprecht 12 USPQ 2d 1235, 1236 (Fed Cir. 1989); In re Bode 193 USPQ 12 (CCPA) 1976). Wilkhu et al clearly teach coated microparticulates comprising an active agent including cannabinoids and disclose that “Different forms of administration may be utilized to deliver the formulations described herein, including (but not limited to) oral, parenteral, inhalation topical”. Thus, Wilkhu et al clearly teach the claimed invention. Additionally, it is noted that, as clearly stated in the “claim interpretation” section of the rejection, that the claims are drawn to a powdery composition, and that where it is stored in or how it is delivered are not limitations that materially affect the claimed powdery composition. Additionally, DeHaan et al teach a dry powder composition comprising a cannabinoid contained within a dry powder inhaler.
Therefore, the references are both in the same field of endeavor and reasonably pertinent to the claimed subject matter.
Applicant’s next argument is that “The problem addressed in the present application and Temtsin-Krayz and DeHann is providing inhalable pharmaceutical compositions. The problem solved by Wilkhu is entirely different and unrelated: the application and use of a pH-dependent polymer to ensure good delivery to the gut after oral administration” (See Remarks, page 8).
This argument is also not found convincing. “In determining obviousness, neither the particular motivation to make the claimed invention nor the problem the inventor is solving controls. The proper analysis is whether the claimed invention would have been obvious to one of ordinary skill in the art after consideration of all the facts.” MPEP § 2141. Here it has been shown that Wilkhu et al teach coated microparticles of cannabinoid in a dry powder formulation and for inhalation. Temtsin-Krayz and DeHaan et al both teach dry powder compositions comprising microparticles of cannabinoid for administration via a nasal or inhalation device.
Claims 1-4, 6, 14-15, 20-21, 23, 25, 28-29, 31, 36-37, 40 and 58-59 are rejected.
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.
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/Mina Haghighatian/
Mina Haghighatian
Primary Examiner
Art Unit 1616
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