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 .
Priority
This application, filed on 02/24/2022, claims priority from BE2021/5139, filed on 02/26/2021.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 10/31/2024 has been entered.
Election/Restriction
Applicant’s response filed on 10/30/2025 to Restriction/Election Requirement filed on 09/12/2025, is acknowledged. Applicant elected with traverse Group II drawn to a composition in the form of a friable/brittle thermoformed extrudate of at least one natural or synthetic cannabinoid and natural or synthetic saccharides including modified starches. Claims 54-63 read on the elected Group. Claims 17, 19, 22, 38, 49 and 51-53 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Response to Argument
Applicant argues:
It is respectfully submitted that claims could be examined together without imposing an undue burden. As stated in §803 of the Manual of Patent Examining Procedure (MPEP), "[i]f the search and examination of all the claims in an application can be made without serious burden, the Examiner must examine it on the merits, even though it includes claims to distinct or independent inventions." Under this standard, it is believed the search of groups jointly would not impose a serious burden. The Restriction Requirement indicates that the two groups have different classifications, namely Group I is classified in A61K 45/06, and Group II is classified in A61K 31/658. Notably, A61K 31/658 incorporates a prior classification of A61K 31/05. The Examiner has previously conducted multiple searches of A61K 45/06 and A61K 31/05 (now A61K 31/658) together. Such as search was conducted on May 22, 2023. The Restriction Requirement also indicated that different search queries are needed to search the two groups. However, the search history shows that the Examiner has already conducted searches combining proteins and saccharides. Several such searches were conducted on May 18, 2023. In addition, Group I and Group II are connected in design, operation, and effect. Because the record establishes that there would be no serious burden to continue to search the two classifications of Group I and Group II, as has been done repeatedly during the pendency of this application and because Group I and Group 11 are related in design, operation, and effect, the Application requests reconsideration and withdrawal of the restriction requirement.
Examiner response:
Applicant's arguments have been fully considered but they are not persuasive for the following reasons. In the amendments filed on 08/08/2025, claims 17, 22, and 49 were amended, and claims 51-63 were added. The added claims, specifically claims 54-63 were directed to a composition in the form of a friable/brittle thermoformed extrudate comprising a natural or synthetic non-euphoric cannabinoid, and modified starches selected from the group consisting of octenyl succinate starch, acid treated starch, or acetylated starch. The composition of the added claims is distinct from the previous composition in terms of the components of the composition (e.g., the carriers of claim 17 are distinct from the modified starches recited in the newly added claims 54-63). These differences lead to two compositions not capable of use together or that can have a materially different design, mode of operation, function, or effect, and the inventions do not overlap in scope because the cannabinoid composition of claim 17 and its dependent claims can be used in the treatment of autoimmune disease, multiple sclerosis, and Crohn's disease, according to US20220265743A1 (cited in the PTO-892 dated 09/12/2025, discloses composition of cannabinoid and pea protein), whereas composition of the newly added claims 54-63 is used to treat insomnia, interrupted sleep, and jet-lag according to WO 2018/152334 A1 (Cited in the previous PTO-892 dated 11/15/2023, discloses composition of cannabinoid and pregelatinized starches). Furthermore, the inventions as claimed do not encompass overlapping subject matter and there is nothing of record to show them to be obvious variants, because the claims of Group II require saccharides and pea protein derivatives do not encompass saccharides, and claims of Group I require pea protein and saccharides do not encompass pea protein or derivates thereof. With regard to serious burden to Examiner, the inventions have acquired a separate status in the art in view of their different classification; the inventions have acquired a separate status in the art due to their recognized divergent subject matter; the inventions require a different field of search (for example, searching different classes/subclasses or electronic resources, or employing different search queries). Moreover, the prior art applicable to one invention would not likely be applicable to other inventions. For these reasons, the restriction requirement is deemed to be proper and is therefore made FINAL.
Status of Claims
Amendment and applicant argument filed on 08/08/2025 have been received and have been carefully considered. Claims 17, 22 and 49 were amended, claim 23, 39-48 and 50 were currently cancelled, claims 1-16, 18, 20-21, 24, 27-37 were previously cancelled, and claims 51-63 were added. The Applicant’s Arguments submitted on 10/30/2025 have been received and have been carefully considered.
Currently, claims 17, 19, 22, 25-26, 38, 49 and 51-63 are pending with claims 17, 19, 22, 38, 49 and 51-53 are withdrawn, and claims 54-63 are under consideration.
Claim interpretation
Examination requires claim terms first be construed in terms in the broadest reasonable manner during prosecution as is reasonably allowed in an effort to establish a clear record of what applicant intends to claim. See MPEP § 2111. Under a broadest reasonable interpretation, words of the claim must be given their plain meaning, unless such meaning is inconsistent with the specification. See MPEP § 2111.01. It is also appropriate to look to how the claim term is used in the prior art, which includes prior art patents, published applications, trade publications, and dictionaries. MPEP § 2111.01 (III). However, specific embodiments of the specification cannot be imported into the claims, particularly where the subject claim limitation is broader than the embodiment. MPEP § 2111.01(II).
Claim interpretation for “Thermoformed Extrudate” and “friable/brittle”
Independent claims 17 and 54 recite “a composition in the form of a friable/brittle thermoformed extrudate…” The instant specification defined “thermoformed extrudate” as:
“A material which comes out of an apparatus, in particular which comes out of an extruder, in which it has undergone a transformation by the effect of heat, optionally by the combined effect of heat and of shear forces of a worm screw. Such a transformation by the effect of heat, optionally by the combined effect of heat and of shear forces of a worm screw, can be obtained with the Hot Melt Extrusion, HME, technique.” [Instant specification, pg. 9, ln. 24-31].
As such the term “thermoformed extrudate” is interpreted as a material in the form of dispersion obtained by heat and shear force i.e., hot melt extrusion technique.
The instant specification defined “friable/brittle” as:
“The terms "friable/brittle thermoformed extrudate", refer, within the meaning of the present invention, to an extrudate which easily disaggregates, which can be easily reduced to powder and/or to small fragments/pieces.” [Instant specification, pg. 12, ln. 6-9].
As such the term “friable/brittle” is interpreted as a powder or small pieces extrudate that does not have elastic or sticky properties.
Therefore, the friable/brittle thermoformed extrudate will be interpreted as a powder or small pieces composition comprising at least one natural or synthetic non-euphoric cannabinoid and at least one natural or synthetic carrier.
Claim interpretation for “plasticizer”
Claims 22 and 43-46 recite “the composition according to claim 17, further including at least one plasticizer.”
The instant specification defined “plasticizer” as:
“Preferentially, according to the invention, said plasticizer is chosen from the group consisting of polyols, lipids, lecithins, sucrose esters, water, triethyl citrate, polyethylene glycol, glycerol, dibutyl sebate, butyl stearate, glycerol monostearate, sodium dodecyl sulphate, diethyl phthalate, the derivatives thereof and the mixtures thereof.” [Instant specification, pg. 37, ln. 23-27].
As such the term “plasticizer” is interpreted consistent with the instant specification.
Withdrawn Claim Rejection - 35 USC § 103
Rejection to claims 17, 19, 22-23, and 39-48 under 35 U.S.C. 103 as being unpatentable over A. Silcock (WO 2020/240184 A1, 12/03/2020) in view of W. Faraci (WO 2018/152334 A1, 08/23/2018), is withdrawn in view of Applicant amendment filed on 08/08/2025 and the response for Restriction Requirement that elected Group II drawn to claims 54-63, and withdraw claims 17, 19, 22, 38, 49 and 51-53 from further consideration.
Rejection to claims 38 and 49 under 35 U.S.C. 103 as being unpatentable over A. Silcock (WO 2020/240184A1, 12/03/2020) in view of W. Faraci (WO 2018/152334 A1, 08/23/2018), further in view of D. Friedman (WO 2019/159174 A1, 08/22/2019), is withdrawn in view of Applicant amendment filed on 08/08/2025 and the response for Restriction Requirement that elected Group II drawn to claims 54-63, and withdraw claims 17, 19, 22, 38, 49 and 51-53 from further consideration.
Rejection New in view of the Amendment
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
§ 103 Rejection over Silcock in view of Faraci and Bromley
Claims 54-58 and 62 are rejected under 35 U.S.C. 103 as being unpatentable over A. Silcock (WO 2020/240184 A1, 12/03/2020, “Silcock” cited in the previous PTO-892 dated 06/01/2023) in view of W. Faraci (WO 2018/152334 A1, 08/23/2018, “Faraci” cited in the previous PTO-892 dated 11/15/2023) and P. Bromley (US PG PUB 20150110924 A1, “Bromley” cited in the PTO-892).
Silcock teaches a cannabinoid composition for providing good bioavailability and stability of the cannabinoid active, and providing delivery of the cannabinoid to the gastric and colon areas. [0037]. Silcock teaches that:
“Cannabinoids are also known to metabolize quickly, particularly when delivered as an oral solution. For example, the cannabinoid cannabidiol (CBD) quickly degrades in the body to 7-hydroxy cannabidiol (7-OH CBD) which then subsequently degrades to 7-carboxy cannabidiol (7-COOH CBD). In the treatment of epilepsy, it is known that the 7-OH metabolite is active but the 7-COOH metabolite (which is the final metabolite) is inactive and as such the rapid degradation from CBD to 7-COOH CBD is unwanted and requires more active to be provided to successfully treat a patient. Consequently, avoiding or slowing down the metabolism of the cannabinoid would enable a medicament that produces better bioavailability and would allow for lower doses of medicine to be provided. Specifically delivering drugs to the colon or intestines has been a desirable target for drug delivery systems but thus far have not provided a formulation which comprises the challenging drug substance of cannabinoids. The approaches for colon specific drug delivery are to utilise excipients that interact with one or more aspects of the gastrointestinal system. In addition, the formulation must be able to resist digestion within the stomach.” [0033]- [0036].
Silcock teaches in one embodiment a formulation in the form of a suspension comprising microparticulates which comprise the active agent of a cannabinoid in addition to excipients which enable targeted delivery to the colon or intestines and avoid digestion in the stomach, [0038]. Silcock teaches that the microparticulate cannabinoid formulation comprising one or more cannabinoids and a pH dependent release polymer, wherein the one or more cannabinoids are taken from the group consisting of cannabichromene (CBC), cannabichromenic acid (CBCV), cannabidiol (CBD), etc., wherein the one or more cannabinoids are a pure, isolated or synthetic cannabinoid, and wherein the pH dependent release polymer includes acetyl and succinoyl groups polymers for enhancing solubility of poorly soluble drugs i.e., cannabinoids, specifically when the cannabinoid formulated into a solid dispersion, [0095], [0096], [00100]. Silcock teaches that preferred composition is microparticulate of cannabinoid and polysaccharide able to minimize cannabinoid metabolism and protect the cannabinoid from degradation. [0127].
Silcock teaches that the formulation is an oral dosage form selected from the group consisting of a mucoadhesive gel; a tablet; a powder; a liquid gel capsule; a solid capsule; an oral solution; an oral suspension; a granulate; and an extrudate. [Silcock, pg. 7, 0061].
Silcock teaches a method of preparing the micro particulate cannabinoid containing formulation, comprising: Preparing a mixture of the cannabinoid and pH dependent release polymer; producing an intermediate powder blend; Processing the intermediate powder blend through a hot melt extruder; Pelleting the extrudates; and milling the pellets to 250-500 pm. [Silcock, pg. 8, 0066].
While Silcock teaches that the hot melt extrudate cannabinoid composition comprises polysaccharide for providing solubility, stability and delivery, Silcock does not teach that the polysaccharide is modified starches (pregelatinized starches).
Faraci teaches a composition comprising cannabinoid or cannabinoid extract formulated in a solid oral dosage, [Faraci, pg. 3, ln. 1-9], wherein the composition improved dissolution, stability, and pharmacokinetics, including absorption and/or oral bioavailability, [Abstract], wherein the composition used in a method of treating or preventing a condition in an animal or human including Alzheimer Disease, pain, anxiety, nausea, vomiting, insomnia, restless leg syndrome (RLS), diabetes mellitus, dystonia, epilepsy, fibromyalgia, gastrointestinal disorders, inflammatory bowel disease, rheumatoid arthritis, migraine, etc. [Faraci, pg. 54, ln. 2-30]. Faraci teaches that the cannabinoid composition comprises starches include, pregelatinized starches, or crosslinked starches, [Faraci, pg. 45, ln. 21-23].
Moreover, Bromley teaches compositions contain a modified food starch and one or more non-polar compounds, wherein the non-polar compound is cannabinoid, [Abstract, [0032]]. Bromley teaches:
Non-polar compounds are not easily dissolved in aqueous solutions, such as water or other polar solvent. A number of non-polar compounds are used in compositions for human ingestion, for example, pharmaceuticals, nutraceuticals and/or dietary supplements. Because of poor water solubility, inclusion of non-polar compounds in products for human consumption, for example, supplements, foods and beverages, is often challenging. Available compositions containing non-polar compounds, and methods for formulating such compositions, are limited. Thus, there is a need to develop compositions for human consumption. [0010]-[0011].
Bromley teaches that formulating the non-polar compound e.g., cannabinoid, with modified starch overcome the formulation difficulties, Poor water solubility, and poor bioavailability. [0304]. Bromley teaches that the modified starch surrounds the non-polar compound e.g., cannabinoid, which provides protection against metabolic degradation. [0311], [0192].
Bromley teaches that the starch can be modified physically, enzymatically, chemically or by any combination thereof. For example, the modified food starch can be modified by pregelatinization, esterification, cross-linking, acetylation, wherein the modified starches include octenyl succinate starches (e.g., sodium octenyl succinate starch) [0031], or acid modified starch. [0550].
Bromley teaches that the composition is formulated as hot melt, (e.g., obtained by heat and mixing), [0775]-0779], [0801], [0815].
Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of instantly claimed invention to utilize the modified starch taught by Bromley and Faraci in the Silcock’s composition for treating or preventing Alzheimer Disease, pain, anxiety, nausea, epilepsy, gastrointestinal disorders, rheumatoid arthritis, migraine, etc. One of ordinary skill in the art would have been motivated to utilize the modified starch and substitute Silcock’s polysaccharide with the modified starch with reasonable expectation of success because Silcock looking to formulate a cannabinoid composition with good cannabinoid bioavailability, stability, and delivery of the cannabinoid to the gastric and colon areas; Silcock specifically teaches that the composition is aim to minimize cannabinoid quick degradation, to slow down the metabolism of the cannabinoid which allow for lower dose of drug, and to delivering cannabinoid to the colon or intestines, a desirable target for drug delivery systems [0033]- [0036]; Silcock teaches that the cannabinoid composition can be formulated with excipients which enable targeted delivery to the colon or intestines and avoid digestion in the stomach, [0038]; Bromley utilize modified starch is to formulate composition for non-polar compound, e.g., cannabinoid composition to overcome the formulation challenges, poor water solubility, and poor bioavailability [0304]; Bromley utilize modified starch to provides protection against metabolic degradation. [0311], [0192]; Bromley composition is also formulated as hot melt, (e.g., obtained by heat and mixing); and Faraci teaches that the cannabinoid composition comprising modified starch (pregelatinized starches) improved dissolution, stability, and pharmacokinetics, including absorption and/or oral bioavailability. The properties and advantages of modified starch taught by Bromley and Faraci i.e., cannabinoid solubility, stability, delivery and protection against degradation are matched the properties Silcock is looking for in the excipient to formulate the hot-melt extrude cannabinoid composition. The properties and advantages of modified starch taught by Bromley and Faraci would motivate skilled artisan to utilize the modified starch in Silcock cannabinoid hot-melt extruder composition, and therefore, meet each and every limitation of claim 54.
With regard to claim 55, Silcock teaches that the cannabinoids are taken from the group consisting of cannabichromene (CBC), cannabichromenic acid (CBCV), cannabidiol (CBD), etc., wherein the one or more cannabinoids are a pure, isolated or synthetic cannabinoid. [0041], [0042].
With regard to claims 56, 57, and 58, Bromley teaches that the modified starches include octenyl succinate starches [0031], acid modified starch [0550], corn maize, sodium starch octenyl succinate, sold under the name N-creamer 46 (substituted waxy maize), [0552].
With regard to claim 60, Bromley teaches that the amount of the modified starch is about 70% by weight of the composition, and the amount of the active compound i.e., cannabinoid is between about 1-25% or about 20% of the weight of the composition. [0012], [0013]. Moreover, Faraci teaches that the amount of cannabinoid in the composition is about more than 10%, 20-30%, etc. [Claims 18-19]. Faraci teaches that in some embodiments, the composition comprises cannabinoid in an amount of at least at least 20 wt%, [Pg. 19, ln. 1-3]. Faraci’s ranges render the claimed amount obvious because Faraci’s ranges encompassed and overlapped with the claimed amount, see MPEP 2144.08. Furthermore, MPEP 2144.05.II.A explains: “Generally, differences in concentration will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).” Furthermore, the optimization of known percent amounts for known active agents is considered well within the competence level of an artisan of ordinary skill in the pharmaceutical sciences.
With regard to claims 61-62, Silcock teaches that the formulation further comprises glycerol as a surfactant at a concentration of about 20-35%, [0017]. Faraci teaches that the surfactant is selected from polyethylene glycol, glycerol, etc. [Pg. 14, ln. 17, 27, Pg. 45, ln. 3]. Faraci teaches that in some embodiment, the amount of the surfactant is 10-30 wt.%; 15-25 wt.% [Claims 101, 102]. Silcock’s and Faraci’s surfactant meet the definition of plasticizer as discussed above in claim interpretation. Silcock and Faraci’s ranges render the claimed amount obvious because Silcock and Faraci’s ranges encompassed and overlapped with the claimed amount, see MPEP 2144.08. Furthermore, MPEP 2144.05.II.A explains: “Generally, differences in concentration will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).” Furthermore, the optimization of known percent amounts for known active agents is considered well within the competence level of an artisan of ordinary skill in the pharmaceutical sciences.
§ 103 Rejection over Silcock, Faraci, and Bromley in view of LEROMA
Claim 59 is rejected under 35 U.S.C. 103 as being unpatentable over A. Silcock (WO 2020/240184 A1, 12/03/2020, “Silcock” cited in the previous PTO-892 dated 06/01/2023) in view of W. Faraci (WO 2018/152334 A1, 08/23/2018, “Faraci” cited in the previous PTO-892 dated 11/15/2023) and P. Bromley (US PG PUB 20150110924 A1, “Bromley” cited in the PTO-892), as applied above to claims 54-58, and 62, further in view of LEROMA, JAN. 2021, https://leroma.de/blog/id/sustainable-alternative-pea-starch-concentrate.html, “LEROMA” cited in the PTO-892).
The combination of Silcock, Faraci and Bromley teaches the use of hot-melt extruder to formulate a composition in the form of a friable/brittle thermoformed extrudate comprising a natural or synthetic non-euphoric cannabinoid, and modified starches selected from the group consisting of octenyl succinate starch, acid treated starch, or acetylated starch, wherein the modified starch is corn maize starch. However, the combination of Silcock, Faraci, and Bromley does not teach that the modified starch is pea starch.
Bromley teaches that the starch can be modified by acetylation, wherein the starch is modified corn, potato, wheat, rice, tapioca, sago, oat, barley, amaranth, waxy corn, cassava, waxy barley, waxy rice, glutinous rice or sweet rice starch.
LEROMA teaches the advantages of using pea starch over wheat, potato and corn starches. LEROMA teaches that pea starch in comparison to the other starches, is a natural source of proteins, minerals, fiber, and low digestible starch. LEROMA teaches that pea starch makes products with a low glycaemic index, particularly important to control insulin resistance-related diseases, and vegan, and gluten-free formulations. LEROMA teaches that pea starch is highly soluble in water make it excellent for dispersion and mixing behavior, is high resistant starch with stability against shear forces, acids, high temperatures and enzymes, and it’s good for dry milling.
Therefore, one of ordinary skill in the art would have been motivated to substitute the corn, potato, or wheat starch with pea and use acetylated pea starch in place of corn starch for the composition taught by Silcock, Faraci and Bromley. One of ordinary skill in the art would have been motivated to do so with reasonable expectation of success because
LEROMA teaches that pea starch is advantageous over other starches for many reasons including pea starch is a source of many nutrients, has low glycaemic index, low content of fast digestible starches, does not produce high glucose peaks, is highly soluble in water, is highly stable against shear forces, and it is suitable for dry milling. Therefore, the combination of Silcock, Faraci, Bromley and LEROMA meet the limitations of claim 59.
§ 103 Rejection over Silcock, Faraci, and Bromley in view of Friedman
Claim 63 is rejected under 35 U.S.C. 103 as being unpatentable over A. Silcock (WO 2020/240184 A1, 12/03/2020, “Silcock” cited in the previous PTO-892 dated 06/01/2023) in view of W. Faraci (WO 2018/152334 A1, 08/23/2018, “Faraci” cited in the previous PTO-892 dated 11/15/2023) and P. Bromley (US PG PUB 20150110924 A1, “Bromley” cited in the PTO-892), as applied above to claims 54-58, and 62, further in view of D. Friedman (WO 2019/159174 A1, 08/22/2019, “Friedman” cited in the PTO-892 dated 03/13/2025).
The combination of Silcock, Faraci and Bromley teaches the use of hot-melt extruder to formulate a composition in the form of a friable/brittle thermoformed extrudate comprising a natural or synthetic non-euphoric cannabinoid, and modified starches selected from the group consisting of octenyl succinate starch, acid treated starch, or acetylated starch. However, the combination of Silcock, Faraci, and Bromley does not teach that the at least one natural or synthetic non-euphoric cannabinoid is over 50% by mass an amorphous phase and the remaining mass a crystalline phase.
In the same field of endeavor, Friedman teaches a solid solution composition comprising one or more cannabinoids as active agents, wherein said cannabinoids are dissolved in a solvent system comprising non-ionic emulsifiers and solid matrix-forming agents. [Abstract]. Friedman teaches that the cannabinoids prepared as a hot melt extrusion dissolved in a mixture of emulsifiers and solid matrix forming agents such as polymers and waxes. [Pg. 3, [0012], ln. 24-26]. The solid solution of cannabinoid is not a pure crystalline solid dispersion or pure amorphous solid dispersion. [Pg. 2, [0005]]. Friedman teaches a cannabinoid composition wherein in formulation II there is about 18% of the CBD is in crystals state, wherein formulation II shows that over 80 of the CBD is solubilized and in a solid solution form. [Pg. 50, [00170], ln. 12-17]. Note that 18% in crystalline state indicates that the rest of cannabinoid is in amorphous phase, which reads on claim 38 “over 50% by mass an amorphous phase and the remaining mass a crystalline phase.”
Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of instantly claimed invention to use crystalline and amorphous phase of cannabinoid in the composition of Silcock and Faraci e.g., over 50% of amorphous phase in view of the teachings of Friedman. One of ordinary skill in the art would have been motivated to do so with reasonable expectation of success because Friedman teaches that a composition comprising amorphous and crystalline phase provide solubilized cannabinoid and is more stable and has a longer shelf life and different polymer excipients can be employed to prepare immediate and sustained release profiles via the hot melt extrusion. Therefore, the combination of Silcock, Bromley, Faraci and Friedman meets the limitations of claim 63.
Conclusion
Claims 54-63 are rejected. 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MANAHIL MIRGHANI ALI ABDALHAMEED whose telephone number is (571)272-1242. The examiner can normally be reached M-F 7:30 am - 5:00 pm.
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/M.M.A./Examiner, Art Unit 1622
/JAMES H ALSTRUM-ACEVEDO/
Supervisory Patent Examiner, Art Unit 1622