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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 12/04/2025 has been entered.
Status of Claims
The amendments and arguments filed on 12/04/2025 are acknowledged and have been fully considered. Claims 1-3, 45, 49, and 52-57 are now pending. Claims 4-44, 46-48, and 50-51 are canceled; claims 45 and 49 are withdrawn; claim 57 is new.
Claims 1-3 and 52-57 will be examined on the merits herein.
Objections/Rejections Withdrawn
Rejections and/or objections not reiterated from previous Office Actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied, and constitute the complete set presently being applied to the instant application.
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.
Claim 57 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. The claim recites the limitation of components (a) and (b) form a “substantially homogeneous mixture”, however there is no previous mention of a “substantially homogeneous mixture” in the disclosure. As such, this is considered new matter. The specification does teach that the components form a homogeneous mixture (see instant specification as filed, examples), but do not teach a “substantially” homogenous mixture specifically.
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 52 and 57 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.
Claim 1 recites the limitation of “wherein the one or more intra-granule excipients comprise one or more surfactants, the one or more surfactants comprising one or more poloxamers”. Claim 52 limits the one or more surfactants to be consisting of polysorbates and polyethylene glycol esters of ricinoleic acid. It is not clear if the surfactants are meant to be in place of the surfactant of claim 1 or used additionally, especially as the consisting of language limits the use of other surfactants in the composition. One with ordinary skill in the art would not understand the metes and bounds of the claims as written, thus they are indefinite. For purpose of search and consideration, the claims are understood as such:
Claim 52. The composition of claim 1, wherein the one or more surfactants further comprise…ricinoleic acid.
Claim 57 recites the limitation that components (a) and (b) for a “substantially” homogeneous mixture, however substantially is a relative term with no definition given in the specification or disclosure overall. It is not clear what level of homogeneity would be considered “substantial” (e.g., is 50% considered substantial or is 51% or more considered substantial). As one with ordinary skill in the art would not understand the metes and bounds of the claim as written, it is indefinite. For purposes of search and consideration, the claim is understood to be “The composition of claim 1, wherein…form a homogenous mixture”.
Response to Arguments
Applicant's arguments filed 12/04/2025 have been fully considered but they are not persuasive. Claim 52 still has the issue as discussed on the Office action of 10/18/2025. Applicant argues that the consisting of language applies only to the Markush group in claim 52 (i.e., one or more surfactants) rather than the one or more surfactant of claim 1. However, even with this in mind, the language of the claim is not clear still. Claim 1 has the limitation that the one or more surfactant comprises one or more poloxamers but then claim 52 recites that the one or more surfactant is selected from the group that consists of polysorbates and polyethylene glycol esters of ricinoleic acid. It is not clear whether the surfactant of claim 52 is meant to be in place of the other surfactants in claim 1 or not and as such that is why the claim is indefinite. With the interpretation of the claim offered (and used in the office action), it is clear that the surfactant of claim 52 is used along with the poloxamer of claim 1, rather than instead of it.
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 1-3 and 57 are rejected under 35 U.S.C. 103 as being unpatentable over US PGPUB 20180214412 A1 (Renwick, 2018) in view of US PGPUB 20180147179 A1 (Raber, 2018) as evidenced by NPL3 (A review of disintegration mechanisms and measurement techniques, Markl et al., 2017).
In regards to claims 1-3, Renwick teaches an immediate release pharmaceutical composition comprising one or more cannabinoids and one or more pharmaceutically acceptable excipients (see Renwick, abstract). Renwick further teaches that the composition comprises granules comprising cannabidiol, dibasic calcium phosphate, lactose monohydrate (both calcium phosphate and lactose monohydrate are diluents (see Renwick, paragraphs 0071-0072)), pregelatinized modified starch, and hydroxyl ethyl cellulose (see Renwick, paragraphs 0025-0030). Renwick also teaches that the composition comprises an opiate such as morphine as an additional active (see Renwick, paragraph 0037).
Renwick is silent on the composition comprising particles between about 20µm and about 2000µm in diameter and the use of a poloxamer in the composition.
In regards to claim 1 and 57, Raber teaches a powder composition comprising cannabinoids and mixtures of pigments, emulsifiers, or odorants (see Raber, abstract). It is taught that emulsifier is a secondary coating substance of the particle (see Raber, paragraph 0038). The emulsifier is taught to be poloxamer 188 or various Lutrol® emulsifiers (i.e., poloxamers (see Raber, paragraph 0080). It is taught that the cannabinoid coating is first made into a powder which is then used to coat another powder (see Raber, paragraph 0081-0082). Further it is taught that the coating is homogenous over the other powder (see Raber, paragraphs 0034-0035) and as such, it would be understood by one with ordinary skill in the art that the coating itself would also be homogeneous in order to achieve a truly homogeneous coating. It is also taught that the preferred powder mesh size of the powder is from 1-100µm (see Raber, paragraphs 0075-0077). MPEP 2144.05 states that "[i]n the case where the claimed ranges 'overlap or lie inside ranges disclosed by the prior art' a prima facie case of obviousness exists" quoting In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976).
In regards to claim 3, it is taught that the powder is based on cellulose-based polymers (i.e. cellulose derivatives) (see Raber, abstract).
In regards to claims 1-3 and 57, it would have been prima facie obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to combine the teachings of Renwick and Raber to formulate an immediate release pharmaceutical composition comprising granules comprising cannabidiol, hydroxyl ethyl cellulose, poloxamer, and morphine wherein the granules have a powder mesh size of the powder is from 1-100µm as using smaller particle sizes allows for higher loads of agents, such as cannabinoids (see Raber, paragraph 0100). Further it is taught that the use of an emulsifier can enhance the absorption of the cannabinoids by the human body, can produce stronger effects such as physiological, medicinal, sensory (taste, smell, palatability), aesthetic, psychological, and any combination thereof, while also enhancing the homogeneity of the composition (see Raber, paragraph 0080). One with ordinary skill in the art would be motivated to combine the composition of Renwick with the teachings of Raber according to the making a drug formulation (see Renwick, paragraphs 0100-0105) to yield predictable results with a reasonable expectation of success. One with ordinary skill in the art would be motivated to combine prior art elements according to known methods to yield predictable results.
MPEP 2112.01(I) states that “[w]here the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established.” MPEP 2112.01(II) also states that “[p]roducts of identical chemical composition cannot have mutually exclusive properties” and that “[a] chemical composition and its properties are inseparable.” Regarding claim 1, more specifically to the limitation of “wherein the composition releases at least about 30% of the two or more actives over a period of about 30 minutes or less,” the Examiner submits that since the teachings of Renwick and Raber yield an identical immediate release composition as instantly claimed, the ordinarily skilled artisan would have a reasonable expectation of achieving the aforementioned properties.
Renwick also teaches dronabinol has an onset of action of approximately 0.5 to 1 hours after oral administration (see Renwick, paragraph 0006). Further in regards to the limitation, NPL3 teaches that an immediate release tablet (as the one taught by Renwick) is designed to fully disintegrate and dissolve within a short period of time upon exposure to physiological fluids (2.5 to 10 minutes) (see NLP3, page 891, column 1, paragraph 1).
Claim 52 is rejected under 35 U.S.C. 103 as being unpatentable over US PGPUB 20180214412 A1 (Renwick, 2018) in view of US PGPUB 20180147179 A1 (Raber, 2018) as evidenced by NPL3 (A review of disintegration mechanisms and measurement techniques, Markl et al., 2017) as applied to claims 1-3 and 57 above, and further in view of US PGPUB 20180243210 A1 (Coulter et al., 2018).
The teachings of Renwick and Raber have been described supra.
The teachings of Renwick and Raber are silent on the use of a surfactant selected from the polysorbates and polyethylene glycol esters of ricinoleic acid.
Coulter teaches a composition for treatment in the form of granules or powder (see Coulter et al., paragraph 0341) comprising a cannabinoid (see Coulter et al., paragraph 0131) and a combination of surfactants, including glycerol polyethylene glycol ricinoleate (see Coulter et al., paragraphs 0158-0159).
In regards to claim 52, it would have been prima facie obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to combine the teachings of Renwick, Raber, and Coulter et al. to formulate an immediate release pharmaceutical composition comprising granules comprising cannabidiol, hydroxyl ethyl cellulose, morphine, and surfactants (i.e. glycerol polyethylene glycol ricinoleate and poloxamers) as it is known that surfactants are used to facilitate manufacturing and process of the composition (see Coulter et al., paragraph 0192). It would be obvious to one with ordinary skill in the art to combine the surfactant of Coulter et al with the composition of Renwick and Raber according to the making a drug formulation (see Renwick, paragraphs 0100-0105) to yield predictable results with a reasonable expectation of success. One with ordinary skill in the art would be motivated to combine prior art elements according to known methods to yield predictable results.
Claim 53-56 are rejected under 35 U.S.C. 103 as being unpatentable over US PGPUB 20180214412 A1 (Renwick, 2018) in view of US PGPUB 20180147179 A1 (Raber, 2018) as applied to claims 1-3 and 57 above, and further in view of WO 2017202424 A1 (Schou et al., 2017) and WO 2009007768 A1 (Thorengaard, 2009) as evidenced by NPL3 (A review of disintegration mechanisms and measurement techniques, Markl et al., 2017) and WO 2013006305 A1 (Firrell et al., 2013).
The teachings of Renwick and Raber have been described supra.
The teachings of Renwick and Raber are silent on the composition comprising a plurality of particles in which the particles comprise at least one cannabinoid, but not the non-cannabinoid therapeutic agent or comprise the non-cannabinoid therapeutic agent, but not the cannabinoid or particles that exclude the cannabinoid and non-cannabinoid therapeutic agent.
Schou teaches a powdered composition for immediate delivery of a cannabinoid (see Schou page 3, lines 1-11), such as THC, CBD, and CBN (see Schou, page 9, lines 30-31) in the form of a quick dissolving tablet or chewing gum (see Schou, page 19, lines 25-28).
Schou also teaches that the average particle size of the powdered composition is between 1 and 400µm with at least 75% of the particles having a particle size between 5 and 100µm (see Schou, page 18, lines 5-21).
Schou teaches that an antioxidant is used, such as tocopherol and its salts (i.e., vitamin E) (see Schou, paragraph bridging pages 39-40). Vitamins are taught as a non-cannabinoid therapeutic agent in the instant specification as filed (see paragraph 0027 of instant specification as filed).
Schou further teaches that the composition is in the form of a two-module chewing gum tablet, wherein the modules have different compositions (see Schou, page 72, lines 11-24).
Thorengaard teaches a tablet comprised of modules of compressed granules (see Thorengaard, page 13, lines 26-28) in the form of chewing gum (see Thorengaard, page 7, lines 26-29). Thorengaard teaches that the particles of the invention have a size of 200-2000µm (see Thorengaard, page 13, lines 5-16). Thorengaard teaches that if the active ingredient is a pharmaceutical active, it is advantageous to be comprised in a module substantially free of the gum base and if it is a taste relevant active it may be added in a module as separate particles that are compressed with gum base or incorporated into the gum-based granules (see Thorengaard, page 83, lines 14-24).
In regards to claims 53-56, it would have been prima facie obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to use the teachings of Renwick, and Raber with the teachings of Schou and Thorengaard to formulate an immediate release composition in the form of a chewing gum with multiple modules. Firrell teaches that tocopherol with a fat (such as fatty acids, vegetable oils, among others (see Firrell, paragraph 0025) is used for taste masking, particularly for bitter tasting substances (see Firrell, abstract). These are also taught to be used in the compositions of Schou (see Schou, page 57, lines 8-12) and Thorengaard, especially for providing a smooth surface to the gum base (see Thorengaard, page 50, lines 8-30). Using the teachings of the prior art, one with ordinary skill in the art can envisage a composition as claimed. For example, an immediate release chewing gum with multiple modules with a module comprising particles of the cannabinoid (a pharmaceutical active) and a separate module with particles comprising tocopherol (i.e., vitamin E) with the gum base and particles without the tocopherol (i.e., particles excluding both the cannabinoid and the non-cannabinoid therapeutic). One with ordinary skill in the art would be motivated to combine the teachings of Renwick and Raber with the teachings of Schou and Thorengaard according to the known method of making a drug formulation (see Renwick, paragraphs 0100-0105) to yield predictable results with a reasonable expectation of success. One with ordinary skill in the art would be motivated to combine prior art elements according to known methods to yield predictable results.
Claims 1-3 and 57 are rejected under 35 U.S.C. 103 as being unpatentable over US PGPUB 20200163931 A1 (Dely, 2020; US PGPUB of WO 2018071581 A1 as submitted on IDS of 01/29/2020) in view of US PGPUB 20180147179 A1 (Raber, 2018) evidenced by NPL3 (A review of disintegration mechanisms and measurement techniques, Markl et al., 2017).
In regards to claims 1-3, Dely teaches an oral hard-fill formulation for the immediate release of cannabinoids (see Dely, paragraph 0011) comprising a cannabinoid in a powder form derived from a granulation utilizing microcrystalline cellulose as the carrier (see Dely, paragraph 0014). Further, the carrier comprises cellulose, microcrystalline cellulose, silicified microcrystalline cellulose, starch, pregelatinized starch, dicalcium phosphate, tricalcium phosphate, and mixtures thereof (see Dely, paragraph 0026). Further, the granules are blended with sodium starch glycolate to form a powder blend which is encapsulated into a hard-shell capsule (see Dely, paragraph 0031).
Dely is silent on the composition comprising particles between about 20µm and about 2000µm in diameter, the use of a poloxamer, and the use of a non-cannabinoid therapeutic agent in the particles of the composition.
The teachings of Raber have been described supra. Raber further teaches that the composition comprises terpenes, such as vitamin A and vitamin K (see Raber, paragraphs 0008, 0032). Vitamins are taught as a non-cannabinoid therapeutic agent in the specification as filed (see instant specification, paragraph 0029).
In regards to claims 1-3 and 57, it would have been prima facie obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to combine the teachings of Dely and Raber to formulate an oral hard-fill formulation for the immediate release of cannabinoids steroid (see Dely, paragraph 0011) and a vitamin comprising a cannabinoid in a powder form derived from a granulation utilizing microcrystalline cellulose as the carrier, wherein the granules have a powder mesh size of the powder is from 1-100µm as using smaller particle sizes allows for higher loads of agents, such as cannabinoids (see Raber, paragraph 0100). Further it is taught that the use of an emulsifier can enhance the absorption of the cannabinoids by the human body, can produce stronger effects such as physiological, medicinal, sensory (taste, smell, palatability), aesthetic, psychological, and any combination thereof, while also enhancing the homogeneity of the composition (see Raber, paragraph 0080). One with ordinary skill in the art would be motivated to combine the compositions of Dely and Raber according to the making a hard-fill formulation (see Dely, paragraph 0031) to yield predictable results with a reasonable expectation of success. One with ordinary skill in the art would be motivated to combine prior art elements according to known methods to yield predictable results. MPEP 2144.05 states that "[i]n the case where the claimed ranges 'overlap or lie inside ranges disclosed by the prior art' a prima facie case of obviousness exists" quoting In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976).
MPEP 2112.01(I) states that “[w]here the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established.” MPEP 2112.01(II) also states that “[p]roducts of identical chemical composition cannot have mutually exclusive properties” and that “[a] chemical composition and its properties are inseparable.” Regarding claim 1, more specifically to the limitation of “wherein the composition releases at least about 30% of the two or more actives over a period of about 30 minutes or less,” the Examiner submits that since the teachings of Dely and Raber yield an identical immediate release composition as instantly claimed, the ordinarily skilled artisan would have a reasonable expectation of achieving the aforementioned properties.
Further in regards to the limitation, NPL3 teaches that an immediate release tablet (as the one taught by Dely) is designed to fully disintegrate and dissolve within a short period of time upon exposure to physiological fluids (2.5 to 10 minutes) (see NLP3, page 891, column 1, paragraph 1).
Claim 52 is rejected under 35 U.S.C. 103 as being unpatentable over US PGPUB 20200163931 A1 (Dely, 2020; US PGPUB of WO 2018071581 A1 as submitted on IDS of 01/29/2020) in view of US PGPUB 20180147179 A1 (Raber, 2018) as applied to claims 1-3 and 57 above, and further in view of US PGPUB 20180243210 A1 (Coulter et al., 2018) as evidenced by NPL3 (A review of disintegration mechanisms and measurement techniques, Markl et al., 2017).
The teachings of Dely and Raber have been described supra.
Dely and Raber are silent on the use of a surfactant selected from the polysorbates and polyethylene glycol esters of ricinoleic acid.
The teachings of Coulter et al. have been described supra. Coulter teaches that the composition comprises a cannabinoid and another steroid such as budesonide (see Coulter et al., paragraph 0131).
In regards to claim 52, it would have been prima facie obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to combine the teachings of Dely, Raber, and Coulter et al. to formulate an oral hard-fill formulation for the immediate release of cannabinoids (see Dely, paragraph 0011) and another steroid comprising a cannabinoid in a powder form derived from a granulation utilizing microcrystalline cellulose as the carrier and ethanol or isopropanol and surfactants (i.e. glycerol polyethylene glycol ricinoleate and poloxamers) as it is known that surfactants are used to facilitate manufacturing and process of the composition (see Coulter et al., paragraph 0192). One with ordinary skill in the art would be motivated to combine the composition of Dely and Raber with the teachings of Coulter according to the making a hard-fill formulation (see Dely, paragraph 0031) to yield predictable results with a reasonable expectation of success. One with ordinary skill in the art would be motivated to combine prior art elements according to known methods to yield predictable results.
Claims 53-56 are rejected under 35 U.S.C. 103 as being unpatentable over US PGPUB 20200163931 A1 (Dely, 2020; US PGPUB of WO 2018071581 A1 as submitted on IDS of 01/29/2020) in view of US PGPUB 20180147179 A1 (Raber, 2018) and US PGPUB 20180243210 A1 (Coulter et al., 2018) as applied to claims 1-3, 52, and 57 above, and further in view of further in view of WO 2017202424 A1 (Schou et al., 2017) and WO 2009007768 A1 (Thorengaard, 2009) as evidenced by NPL3 (A review of disintegration mechanisms and measurement techniques, Markl et al., 2017) and WO 2013006305 A1 (Firrell et al., 2013).
The teachings of Dely, Raber, and Coulter have been described supra.
The teachings of Dely, Raber, Coulter are silent on the composition comprising a plurality of particles in which the particles comprise at least one cannabinoid, but not the non-cannabinoid therapeutic agent or comprise the non-cannabinoid therapeutic agent, but not the cannabinoid or particles that exclude the cannabinoid and non-cannabinoid therapeutic agent.
The teachings of Schou and Thorengaard are described supra.
In regards to claims 53-56, it would have been prima facie obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to use the teachings of Dely, Raber, Coulter with the teachings of Schou and Thorengaard to formulate an immediate release composition in the form of a chewing gum with multiple modules. Firrell teaches that tocopherol with a fat (such as fatty acids, vegetable oils, among others (see Firrell, paragraph 0025) is used for taste masking, particularly for bitter tasting substances (see Firrell, abstract). These are also taught to be used in the compositions of Schou (see Schou, page 57, lines 8-12) and Thorengaard, especially for providing a smooth surface to the gum base (see Thorengaard, page 50, lines 8-30). Using the teachings of the prior art, one with ordinary skill in the art can envisage a composition as claimed. For example, an immediate release chewing gum with multiple modules with a module comprising particles of the cannabinoid (a pharmaceutical active) and a separate module with particles comprising tocopherol (i.e., vitamin E) with the gum base and particles without the tocopherol (i.e.; particles excluding both the cannabinoid and the non-cannabinoid therapeutic). One with ordinary skill in the art would be motivated to combine the teachings of Dely, Raber, Coulter with the teachings of Schou and Thorengaard according to the known method of making a drug formulation in a chewing gum (see Schou, example 7) to yield predictable results with a reasonable expectation of success. One with ordinary skill in the art would be motivated to combine prior art elements according to known methods to yield predictable results.
Response to Arguments
Applicant's arguments filed 12/04/2025 have been fully considered but they are not fully persuasive in view of the modified grounds of rejection as necessitated by amendment.
In regards to applicant’s argument that Renwick only teaches a monolithic tablet dosage in paragraph 0035, it is pointed out that the tablet is comprised of granules (see Renwick, paragraph 0025-0034).
In regards to applicant’s argument that Raber teaches poloxamer in a coating and not as an intra-granule excipient, it is pointed out that there is no definition laid out in the instant application for a granule or particle and with the broadest reasonable interpretation, the coating on a particle would be considered part of the particle and as such an intra-granule excipient. Applicant argues that an intra-granule surfactant would a component embedded within the matrix of each particle, however this definition is not present in the claims, nor the specification as filed. Attorney argument is not evidence unless it is an admission, in which case, an examiner may use the admission in making a rejection. See MPEP § 2129 and § 2144.03 for a discussion of admissions as prior art. The arguments of counsel cannot take the place of evidence in the record. In re Schulze, 346 F.2d 600, 602, 145 USPQ 716, 718 (CCPA 1965). Further, it is taught that the coating can be a powder coating (see Raber, paragraph 0081-0082). and as such the coating itself would have individual granules.
In regards to applicant’s argument that the discussion of poloxamers in coating layers in Raber does not render intra-granule use of poloxamers obvious, it is pointed out again that there is nothing in the disclosure that would lend one with ordinary skill in the art to understand a coating not a part of the granule itself. Further applicant argues that poloxamer is a amphiphilic block copolymer, which is different than the sodium lauryl sulfate of Renwick (see Renwick, paragraph 0073), and that the rationale used in the rejection does not support the proposed combination. It is pointed out that poloxamer 188 and various Lutrol® are taught as emulsifiers (see Raber, paragraph 0080) and that emulsifiers are known to have a variety of benefits (see Raber, paragraph 0080). It would be within the purview of one with ordinary skill in the art to understand that poloxamer 188, which is taught as an emulsifier, would display at least one, if not all, of the benefits that are known in the art with a reasonable expectation of success. While there are no working examples, data, or formulation discussion in the art of the combination (as that would be anticipation of the instant invention), it is known that the emulsifiers of Raber have benefits as discussed, which give a motivation to combine the emulsifier of Raber with the composition of Renwick to yield a composition that has better absorption of the cannabinoids by the human body or produce a stronger effect, while also enhancing the homogeneity of the composition as taught in Raber (see Raber, paragraph 0080). All of this would also apply to the composition of Dely, as discussed in the rejections above.
As the applicant’s arguments have been rebutted, the rejections over all of the claims are maintained.
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.
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Claims 1-3, 52, and 57 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of U.S. Patent No. 11439595 in view of US PGPUB 20180214412 A1 (Renwick, 2018) and US PGPUB 20180147179 A1 (Raber, 2018).
US Patent 11439595 claims a composition for immediate release of one or more cannabinoids, the composition comprising a population of particles, wherein each particle comprises: (a) the one or more cannabinoids; (b) one or more intra-granule excipients; wherein about 80% of the particles is between about 20 μm and about 2000 μm in diameter; and wherein the composition releases at least about 30% of the one or more cannabinoids over a period of about 30 minutes or less (see claim 1). The dependent claims further teach wherein the one or more intra-granule excipients comprises one or more diluents, one or more binders, one or more fillers, one or more surfactants/emulsifying agents, one or more disintegrants, or a combination thereof (see claim 4), wherein the cellulose derivative is sorbitol (i.e., polysorbate). US Patent 11439595 is silent on the use of a non-therapeutic cannabinoid agent and the use of poloxamer.
The teachings of Renwick and Raber have been described supra.
In regards to claims 1-3, 52, and 57, it would have been prima facie obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to combine the teachings of US Patent 11439595 with the teachings of Renwick and Raber to formulate the composition of the instant claims as it is known that non-cannabinoid therapeutics like opiates are used in immediate release forms of cannabinoids. Further it is taught that the use of an emulsifier can enhance the absorption of the cannabinoids by the human body, can produce stronger effects such as physiological, medicinal, sensory (taste, smell, palatability), aesthetic, psychological, and any combination thereof, while also enhancing the homogeneity of the composition (see Raber, paragraph 0080). It would be obvious to one with ordinary skill in the art to combine the teachings of Patent 11439595 with the teachings of Renwick and Raber according to the known method of making a drug formulation (see Renwick, paragraphs 0100-0105) to yield predictable results with a reasonable expectation of success. One with ordinary skill in the art would be motivated to combine prior art elements according to known methods to yield predictable results.
Claims 1-3, 52, and 57 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 51-57 of copending Application No. 17880420 in view of US PGPUB 20180214412 A1 (Renwick, 2018) and US PGPUB 20180147179 A1 (Raber, 2018).
17880420 teaches a composition for immediate release of one or more cannabinoids, the composition comprising a population of particles, wherein each particle comprises: (a) the one or more cannabinoids; (b) one or more intra-granule excipients; and wherein the composition releases at least about 30% of the one or more cannabinoids over a period of about 30 minutes or less. One limitation that is different is “wherein about 70% of the particles is between about 100 μm and about 700 μm in diameter” of application 17880420, however with no specific definition of about by applicant, and examining the claims under BRI renders the limitation obvious, as it would be within the purview of one with ordinary skill in the art to understand that about 70% of particles being within the range of about 100µm and 700µm and about 80% of the particles being within about 20µm and about 2000µm would have significant overlap and thus would not be patentably distinct. Further 17880420 is silent is silent on the use of a non-therapeutic cannabinoid agent and the use of poloxamer.
The teachings of Renwick and Raber have been described supra.
In regards to claims 1-3, 52, and 57, it would have been prima facie obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to combine the teachings 17880420 with the teachings of Renwick and Raber to formulate the composition of the instant claims as it is known that non-cannabinoid therapeutics like opiates are used in immediate release forms of cannabinoids. Further it is taught that the use of an emulsifier can enhance the absorption of the cannabinoids by the human body, can produce stronger effects such as physiological, medicinal, sensory (taste, smell, palatability), aesthetic, psychological, and any combination thereof, while also enhancing the homogeneity of the composition (see Raber, paragraph 0080). It would be obvious to one with ordinary skill in the art to combine the teachings of 17880420 with the teachings of Renwick and Raber according to the known method of making a drug formulation (see Renwick, paragraphs 0100-0105) to yield predictable results with a reasonable expectation of success. One with ordinary skill in the art would be motivated to combine prior art elements according to known methods to yield predictable results.
This is a provisional nonstatutory double patenting rejection.
Response to Arguments
Applicant's arguments filed 12/04/2025 have been fully considered but they are not fully persuasive.
In regards to applicant’s argument that Raber teaches poloxamer in a coating and not as an intra-granule excipient, it is pointed out that there is no definition laid out in the instant application for a granule or particle and with the broadest reasonable interpretation, the coating on a particle would be considered part of the particle and as such an intra-granule excipient. Applicant argues that an intra-granule surfactant would a component embedded within the matrix of each particle, however this definition is not present in the claims, nor the specification as filed. Attorney argument is not evidence unless it is an admission, in which case, an examiner may use the admission in making a rejection. See MPEP § 2129 and § 2144.03 for a discussion of admissions as prior art. The arguments of counsel cannot take the place of evidence in the record. In re Schulze, 346 F.2d 600, 602, 145 USPQ 716, 718 (CCPA 1965). Further, it is taught that the coating can be a powder coating (see Raber, paragraph 0081-0082). and as such the coating itself would have individual granules.
As such, the rejection is maintained.
Conclusion
No claims allowed.
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/A.A.A./ Examiner, Art Unit 1611