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 .
Status of Claims
The amendments and arguments filed on 03/19/2026 are acknowledged and have been fully considered. Claims 1-10,12, and 18-19 have been amended. Claims 13-17 have been withdrawn. Claims 11 has been canceled; claim 20-25 are new. Applicants’ amendments are supported by the originally filed disclosure.
No new matter has been added.
Thus, claims 1-10,12, and 18-25 will be examined on the merits herein.
Withdrawn Rejections
Rejections under 35 USC 102/103 and 103
Applicants’ amendment to claim 1 is persuasive in overcoming the previously raised prior art rejections based on McGrane et al (US 20190382327 A1) and WAGNER et al (US 20210000789 A1) as well as McGrane and WAGNER further in view of FRIEDMAN (US 20190298683 A1; as submitted on IDS of 02/14/2023). Said rejections are withdrawn.
New Grounds of Rejection — Necessitated by Amendment
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.
Claim(s) 1-2,4-8,10,12 ,18-25 are rejected under 35 U.S.C. 103 as being unpatentable over Taha (US 20160051480 A1) and in view of McGrane et al (US 20190382327 A1) and WAGNER et al (US 20210000789 A1).
Taha discloses coatings and methods for the administration of cannabinoids to a patient, and in a specific embodiment, the coatings and methods may utilize or include cannabinoids, and one or more active pharmaceutical ingredients, wherein said coating is configured for oral delivery through a capsule or tablet (see entire document, for instance, abstract). Taha teaches a coating composed of Cannabinoid is an attractive alternative that not only provides functionality, but is a more natural substitute to the artificial coatings in the market today ([0003]). Taha discloses a tablet includes an outer coating having cannabinoid, and an inner core having one or more active pharmaceutical ingredients substantially encapsulated by the outer coating ([0005]). Taha teaches a capsule includes a cannabinoid outer shell, and an inner content wherein the inner content is within the cannabinoid outer shell (see entire document, for instance [0006], claims 9-15). Taha in Figure D depicts a cannabinoid capsule releasing APIs when open or dissolved (see entire document, for instance, Figure D [0012], [0028]). Taha teaches the inner content of the capsule can be active or inactive ingredients in combination with cannabinoids (see entire document, for instance, claim 16). Taha discloses cannabinoids will be used herein to refer to Cannabidiol (CBD) and other isolated cannabinoids like Cannabinol (CBN) and non-Tetrahydrocannabinol (THC), or very low THC, parts of the Cannabis plant species including by way of non-limiting example Cannabis sativa (including hemp), Cannabis indica and Cannabis ruderalis and all resins, stalks, flowers, seeds and oils related thereto ([0018]). Instant specification discloses cannabis-derived resins also include hemp-derived resins as they also have a similar physical and chemical make-up and can be crystallized ([0014]). However, it a does not expressly disclose including an extraction methods or seal. McGrane et al and WAGNER et al remedy this deficiency.
McGrane discloses crude plant extracts can be processed to yield crystalline materials ([0004]). Crystalline materials may have desirable attributes, such as being more stable and having longer shelf lives than crude plant extracts ([0004]). McGrane teaches THCA crystal structures ([0067]). McGrane discloses an extraction process can be a solventless extraction process ([0062]). McGrane discloses an extraction process can be a solvent-based extraction process ([0030]). McGrane teaches the crystalline material may have higher purity than the original extract (e.g. live resin or crude oil) ([0036]). The crystalline material may have higher potency than the original extract ([0036]). The crystalline material may be more stable and have a longer shelf life than the original extract ([0036]). The crystalline material may be easier to store and transport than the original extract ([0036]). The crystalline material may be easier to precisely dose and administer than the original extract ([0036]). McGrane discloses the cannabis plant extract is a hemp-derived cannabis plant extract (see entire document, for instance, claim 13). The instant specification teaches the cannabis-derived resin can be extracted from any type or strain of cannabis or hemp, including indica, sativa, and ruderalis ([0067]). Instant specification discloses cannabis-derived resins also include hemp-derived resins as they also have a similar physical and chemical make-up and can be crystallized ([0014]).
WAGNER discloses cannabis pods comprising THCA ([0005]). WAGNER teaches “pod” is defined as a single unit package containing ground plant source material ([0048]). The single unit package comprises an outer layer ([0048]). WAGNER discloses a thread may be configured to be fixed in place, alternatively it may be releasable by the user so as to release the inner Cannabis contents of the pod ([0102]). WAGNER teaches pods of encapsulated Cannabis flower (the inner material comprising an ingestible material) ([0026]). WAGNER teaches encapsulating the Cannabis preparation within a textile of primarily natural fiber ([0015]). WAGNER discloses additives such as terpenes ([0014]). WAGNER teaches use of preferred primarily natural fiber textiles for encapsulating the Cannabis preparation ([0033]). WAGNER discloses the textile is integrally formed as a single unitary body ([0089]). The edges of the unitary body may be joined at a junction to seal the Cannabis material therein ([0089]). WAGNER discloses inner material is a cannabis preparation, shell is natural fiber and a seal. WAGNER teaches cannabis plant material preparation is prepared from one or more Cannabis plants selected from the group consisting of Charlotte's Web and other high CBDA, low THCA plant varieties ([0014]). WAGNER discloses examples of naturally sourced materials for use with this invention include Cannabis material ([0085]). Instant specification discloses the cannabis-derived resin may be made mostly of isolated cannabinoids, such as THCA (tetrahydrocannabinol acid extracted from trichomes), CBDA (cannabidiolic acid), CBGA (cannabigerolic acid), or any other cannabinoid resin whose physical and chemical make-up allows it to crystallize or harden ([0068]). WAGNER teaches following extraction of the vaporizable material in a suitable solvent such as methanol (a solvent extraction method) ([0083]). WAGNER discloses the textile comprises materials that exhibit high temperature tolerance and are able to withstand relatively high heat temperatures ([0084]). WAGNER discloses the pods may be oval, spherical, cylindrical, conical, cubic, rectangular, square, pyramid and the like (shaped substantially semi-spherical) ([0093]). WAGNER discloses the dimensions of the pod are not meant to be limiting the thickness may be about 1 mm ([0095]). The pod may be wider or narrower, or thinner or thicker as may be desired ([0095]). WAGNER teaches the pod may include further structure such as coupling features (e.g., threaded portions, elastomeric covers, pull-tabs, tearable strips, flaps etc.) for attaching to the pod ([0099]). For example, when suitably coupled, the coupling feature may form a seal with the fibrous material of the pod ([0099]). Such a seal may be appropriate for locking in the overall aroma and freshness of the Cannabis composition, preserving the contents therein ([0099]). The coupling feature may also function to block external light and air, while the pod is sealed ([0099]).
Thus, would have been obvious to utilize extraction methods and seal as taught in McGrane et al and WAGNER et al in the composition of Taha. One would have been motivated to do so in order to achieve optimal melting point of the dosing capsule. It would be within the purview of the skilled artisan to manipulate amounts of components within said ranges by routine experimentation, with a reasonable expectation of success. It is noted that MPEP 2144.05 states: "Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature 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).” In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists (MPEP 2144.05). In this case, it would be within the purview of the ordinarily skilled artisan to select amounts of each component from within the disclosed ranges, including amounts instantly claimed, by routine experimentation, with a reasonable expectation of success.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the instantly claimed invention, to utilize a capsule comprising crystallized cannabinoid such as THCA or derived from hemp. One would have been motivated to do so since prior art teaches a coating composed of Cannabinoid is an attractive alternative that not only provides functionality, but is a more natural substitute to the artificial coatings in the market today. A tablet includes an outer coating having cannabinoid, and an inner core having one or more active pharmaceutical ingredients substantially encapsulated by the outer coating. As well as crystalline materials may have desirable attributes, such as being more stable and having longer shelf lives than crude plant extracts.
Claim(s) 1-10, 12, and 18-25 are rejected under 35 U.S.C. 103 as being unpatentable over Taha (US 20160051480 A1) and in view of McGrane et al (US 20190382327 A1) and WAGNER et al (US 20210000789 A1) as applied to claims 1-2,4-8,10,12 ,18-25 above, and further in view of FRIEDMAN (US 20190298683 A1; as submitted on IDS of 02/14/2023).
The teachings of Taha, McGrane and WAGNER et al have been set forth above. However, they do not expressly disclose the shell is in a hardened state at ambient temperature, and when the capsule is heated to a pre-determined temperature, the shell liquifies, thereby allowing the inner material to be ingested.
Taha teaches a coating composed of Cannabinoid is an attractive alternative that not only provides functionality, but is a more natural substitute to the artificial coatings in the market today ([0003]). Taha discloses a tablet includes an outer coating having cannabinoid, and an inner core having one or more active pharmaceutical ingredients substantially encapsulated by the outer coating ([0005]). WAGNER discloses the textile comprises materials that exhibit high temperature tolerance and are able to withstand relatively high heat temperatures ([0084]). FRIEDMAN discloses cannabinoid compositions and formulations, to improve administration of cannabinoids (see entire document, for instance, Abstract). FRIEDMAN teaches pharmaceutical composition comprises about 30% to about 80% by weight of a cannabinoid or a mixture of cannabinoids ([0017]). In certain embodiments, the cannabinoid is tetrahydrocannabinolic acid (THCA) ([0017]). FRIEDMAN teaches the dosage form has a melting point of above 40° C. and from 40° C. to 80° C., or 40° C. to 70° C. or 42° C. to 60° C. or 44° C. to 50° C. or 38° C. to 40° C., in such a way that the pharmaceutical composition does not liquefy at storage condition, accelerated stability studies and at body temperature.
Thus, 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 incorporate the composition as described by Taha, McGrane and WAGNER with the composition of FRIEDMAN. One would have been motivated to do so in order to administer therapeutically-effective amounts of cannabinoids in a single unit dose, and provide patients with a convenient route of cannabinoid administration to improve patient compliance ([0010]). It is noted that MPEP 2144.05 states: "Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature 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).” In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists (MPEP 2144.05). In this case, it would be within the purview of the ordinarily skilled artisan to select amounts of each component from within the disclosed ranges, including amounts instantly claimed, by routine experimentation, with a reasonable expectation of success.
Response to Arguments
Applicant’s arguments with respect to claims have been considered but they are not persuasive in view of the modified grounds of rejection as necessitated by amendment.
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, 6-8 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 7,10-12 of copending Application No. 18/835,555 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
The copending claims are directed to a composition for a dosing capsule having a shell made of a cannabis-derived resin; first cannabis-derived resin in powder form; heating the first cannabis-derived resin such that the first cannabis-derived resin powder melts to become liquid; filling the hardened shell in the first mold plate with an inner material; and dispensing a second cannabis-derived resin over the hardened shell and inner material to seal the inner material within the hardened shell. The first cannabis-derived resin comprises THCA. The inner material comprises a cannabis derived resin, a pharmaceutical product. The second cannabis-derived resin comprises THCA.
While the copending claims teach all of the instantly claimed elements, the teaching does not rise to the level of statutory double patenting.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the instantly claimed invention, by doing no more than following the guidance provided in the copending claims to arrive at the instantly claimed invention. One would have been motivated to do so since the copending claims expressly teach the instantly claimed elements and the instantly claimed orientation of said elements, wherein by simply following the guidance of the copending claims one would arrive at the instantly claimed invention.
Response to Arguments
Applicant requests in the Remarks filed 03/19/2026 that the rejection be held in abeyance. Applicant's argument is not found persuasive and the rejection is therefore maintained.
Conclusion
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 JANET JOSEPH whose telephone number is (571)270-1372. The examiner can normally be reached Monday and Thursday 0730-1730 Eastern.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bethany Barham, can be reached at (571)272-6175. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JANET JOSEPH/Patent Examiner, Art Unit 1611
/BETHANY P BARHAM/Supervisory Patent Examiner, Art Unit 1611
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