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 .
DETAILED ACTION
Response to Amendment
Status of the Claims
Receipt of Applicant’s response, filed 02 Apr 2026 has been entered.
Claims 1, 4-7, 11, 12, 14, 15, 17, 18, 20, 21, 24, 25, and 27-32 remain pending in the application.
Claims 1, 4, and 27 are amended.
Claim 2, 3, 8-10, 13, 16, 19, 22, 23, and 26 are cancelled.
Claims 31 and 32 are new.
Claims 1, 4-7, 11, 12, 14, 15, 17, 18, 20, 21, 24, 25, and 27-32 are under consideration to the extent that the bioactive ingredient is psilocybin or cannabinoid, the terpene is β-caryophyllene, cineole, eucalyptol, pulegone, linalool, myrcene, pinene, limonene, or borneol, and the fibrous matrix material is coconut coir.
Objections Withdrawn
Objections to the Claims
The claim objections set forth in the Non-Final Office Action mailed 01 Dec 2025 are hereby withdrawn in light of applicant’s amendments of the claims.
Rejections Withdrawn
Rejections Pursuant to 35 USC § 112
The rejections of claims pursuant to 35 U.S.C. 112(b) set forth in the Non-Final Office Action mailed 01 Dec 2025 is hereby withdrawn in light of applicant’s amendment of the claims.
Rejections Maintained – in modified form
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.
The rejection below was made previously and has been modified to reject new claims 31 and 32.
Claims 1, 4-7, 11, 12, 14, 17, 18, 20, 21, 24, 25, and 27-32 are rejected under 35 U.S.C. 103 as being unpatentable over Mandel et al. (US 2019/0060225, Published 28 Feb 2019, included in the IDS filed 20 Jan 2022) in view of Mishra et al. (US 2014/0271791, published 18 Sep 2014), Bruun et al. (WO 2018/233782, published 27 Dec 2018), Rushforth et al. (US 2014/0026912) and Lindsay et al. (US 2018/0125777, published 10 May 2018, included in the IDS filed 20 Jan 2022) and evidenced by the instant specification.
Mandel teaches compositions and methods for oral administration of water soluble cannabinoids and terpenoids (title, abstract, [0007], [0025]). Mandel teaches an orally administered cannabis product that is disposed within a pouch ([0044]). Mandel teaches that the cannabis product is disposed upon a fibrous carrier such as coconut coir ([0043]). Mandel further teaches that the pouch material may be cellulose ([0044]), rendering obvious the fibrous matrix material of claims 25 and 30. Mandel teaches that the cannabis product is composed of flavoring agents such as stevia and miracle fruit related sweeteners ([0047]), rendering obvious a sweetener and a flavorant as in claims 11, 20 and 27. Mandel teaches that the cannabis product is composed of binding agents such as guar gum, pectin, agar, and gelatin ([0046]). As evidenced by the instant specification, these are all stabilizers (page 18 lines 2-4), rendering obvious the stabilizer of claim 11. Mandel teaches the inclusion of caffeine ([0049], [0060]), rendering obvious the caffeine of claim 1. Mandel teaches terpene and terpenoids for the invention such as beta caryophyllene, linalool, myrcene, pinene, limonene, and borneol ([0033]-[0034]), rendering obvious the terpene of claims 4 and 17. Mandel teaches examples where the active components are mixed with the dry components such as coconut coir ([0058]), rendering obvious the blended composition of claim 18 and that the caffeine is absorbed on coconut coir.
Mandel does not teach that the pouch consists of a plurality of apertures (claim 5, 6, 14, 20) that extend through the fibrous matrix material (claim 14), that each of the plurality of apertures have a diameter that is between about 400 μm to about 800 μm (claims 5, 6 and 29) or that the pouch is adapted to release between 40% to 90% of caffeine present in the fill material in under 15 minutes (claim 1) or 70-90% in under 10 minutes (claim 20) or between 5 to 10 minutes (claim 7) or that the caffeine is above 20% (claims 1, 20 and 27) or the particle size of claims 12, 21, and 24. These deficiencies are made up for in the teachings of Mishra, Bruun, Rushforth, and Lindsay.
Mishra teaches a composition for human consumption comprising a predetermined quantity of a base composition and encapsulated caffeine dispersed throughout at least a portion of the base composition ([0004]). Mishra teaches an oral pouch product comprising a porous pouch wrapper, an inner botanical filling material contained within the pouch wrapper and encapsulated caffeine ([0008]). Mishra teaches that the botanical material includes plant material and the encapsulated caffeine is dispersed throughout the botanical material ([0009]). Mishra teaches that the product has a relatively high caffeine content to provide a consumer with a burst of energy and that caffeine is from about 50 mg to about 200 mg ([0023]).
Bruun teaches a pouch for administration of an active ingredient such as cannabinoid (abstract). Bruun teaches that the pouch may be used as a medicament, for example in use in alleviation of pain or mitigation of appetite deficiency (page 13 line 19 – page 14 line 9). Bruun teaches an embodiment of the invention where the pouch consists of a matrix composition and a sealed barrier enclosing the matrix composition (page 3 lines 23-24, page 17 line 22, page 24 lines 25). Bruun teaches that pouch refers to a container typically formed by a web of fibrous material enclosing a cavity ([page 15 lines 5-6). Regarding claims 12, 21 and 24, Bruun teaches that a preferred composition is in the form of a powder (page 8 lines 13-29) and that the pouch is formed by filling the pouch with the powdered composition and sealing (page 17 line 22). Bruun teaches that the powdered matrix is above 1 micrometer (page 35 lines 15-16) or the particle size is between 1 and 1200 micrometers (page 8 lines 28-29) and further teaches that the average powder diameter is larger than the average opening dimension of the pouch (page 9 lines 4-5), rendering it obvious to have particles greater than the pouch opening, such as greater than 1 micrometer, so that the particles do not fall out of the pouch. Regarding claims 14 and 20, Bruun teaches that the pouches comprise openings, where the characteristic opening dimension is adapted to a characteristic dimension of the matrix composition so as to retain the matrix composition inside the pouch before use and/or to retain a part of the matrix composition, such as an insoluble composition, inside the pouch during use (page 17 lines 1-5). Bruun teaches the pouch membrane allows passage of saliva and prevents or inhibits passage of the matrix composition (page 17 lines 11-12). The term “aperture” as recited in instant claims 14 and 20 is understood in light of the specification as referring to an opening in a fibrous matrix material ([0037]). Therefore, the openings in the pouches as taught by Bruun are understood to read on a plurality of apertures. Additionally, as Bruun teaches that the dimensions of the openings are adapted to the specific matrix composition so as to retain parts of the composition inside the pouch, this is understood to teach that if the openings were too large then components could escape the pouch, thus teaching that the openings extend through the fibrous matrix material, as in claim 14. Bruun teaches that the complete release of cannabinoids may be obtained by a relatively fast release such that within a typical usage time period of 10 minutes, the complete amount of cannabinoids and carrier is released to the oral cavity (page 4 lines 3-6). Bruun teaches target fill weights for the pouch may vary from 250-800 mg of powder per pouch (page 25 lines 6-8).
Rushforth teaches a fleece for a smokeless tobacco pouch that is formed with apertures (abstract, [0005]). Rushforth teaches that the size and range of the apertures are sufficiently large to increase the release of tobacco constituents as well as flavourants as well as sufficiently small to retain almost all of the snus particles received in a snus pouch ([0082]). Rushforth teaches an embodiment of the invention where at least 100% of the apertures have a diameter of at least 100 μm ([0056]). Rushforth additionally teaches an embodiment where the mean diameter of the apertures is at least 400 μm ([0058]). Rushforth teaches that the apertured fleece also has 16-24 visible apertures per cm2 ([0059]).
Lindsay teaches a sublingual dosage form comprising decarboxylated cannabis plant material, and a dispenser for delivering at least one pharmacologically active cannabinoid from the decarboxylated cannabis plant material contained inside the dispenser into the sublingual cavity of a subject when the dispenser is placed within the subject's sublingual cavity with the decarboxylated cannabis plant material contained therein (abstract). Lindsay teaches that a suitable dispenser includes a pouch ([0168]). Lindsay teaches that in some aspects, the invention provides a wrapping comprising a plurality of apertures configured to retain cannabis plant material inside the wrapping while permitting an effective amount of at least one pharmacologically active agent released from the cannabis plant material upon exposure to saliva to flow with the saliva into a subject's sublingual cavity when the wrapping is folded around the cannabis plant material and placed in the subject's sublingual cavity ([0040]).
Therefore, it would have been prima facia obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to have formed an oral pouch comprising openings (i.e. apertures) that extend through the pouch material and where the pouch contains coconut coir carrier and a composition of 50-200 mg caffeine, cannabinoid, a terpene, flavoring agents and a fruit sweetener. Cannabinoid pouches with the inclusion of caffeine and a coconut coir carrier and cannabinoid, terpene, flavoring agents and fruit sweetener are known from Mandel. It is obvious to include 50 mg-200mg caffeine in the pouches as this is able to provide a consumer with a burst of energy, as taught by Mishra. Bruun likewise teaches the oral administration of cannabinoids via a pouch with openings (apertures) and it is known from the teachings of Bruun that the amount of material in a cannabinoid pouch is variable and that suitable amounts are 250-800 mg. The inclusion of 50-250 mg caffeine and the obviousness of varying the amount of fill material in a pouch, for example from 250-800 mg, renders obvious the caffeine in an amount of more than 20% w/w of the fill material. For example, 200mg caffeine and 250-800 mg fill material gives a range of 25%-80% w/w caffeine of the fill material, rendering obvious the limitation of claim 1. The inclusion of opening or apertures in the pouch is obvious as this is a method of forming a pouch, as is known from Bruun, Rushforth and Lindsay. Openings/apertures in a pouch allow for the passage of saliva while preventing passage of the matrix material, as taught by Bruun and Lindsay. It is further obvious to have the particle sizes of the material in the pouch greater than the pouch opening, such as greater than 1 micrometer or between 1-1200 micrometer so that the particles do not fall out, as taught by Bruun, thus rendering the claimed particles sizes of 800 to 900 μm (claims 12, 21 and 27) and 1500-2000 μm (claims 24) as obvious and the ground coconut coir between 600-900 μm (claim 32) as obvious. It would have been further obvious to have a plurality of apertures having a mean diameter of at least 400 μm and where each aperture has a diameter of at least 100 μm according to Rushforth because Bruun, Lindsay and Rushford teach pouches that retain the material inside the pouches, while permitting release of the active agent. As this is a suitable aperture size for retaining the matrix material while allowing for saliva and active agent transferal, one of ordinary skill would have a reasonable expectation of success in having the openings/apertures with a diameter of at least 400 μm, rendering obvious the aperture size of claims 5, 6 and 29. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). Further, in view of the teachings of Bruun, Lindsay and Rushford that the pouches should be designed to retain the material inside the pouch, specifically with apertures small enough to retain certain material as well as large enough to allow desirable materials to be released and that the particle size of the material in the pouch is variable (e.g 1-1200 μm), the aperture size and particulate size are art-recognized result effective variables such that determining that each of the apertures should have a diameter between 400 to 800 μm and that the coconut coir should be ground to 600-900 μm would be a matter of optimization through routine experimentation. "[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). Thus, it would have been obvious to one of ordinary skill in the art to have formed apertures in the pouch with a diameter of between 400 to 800 μm and coir particle sizes from 600-900 μm through routine experimentation in order to appropriately hold and release desired materials from the pouch. Regarding claim 32, it is obvious to have 16-24 visible apertures per cm2 as this density of apertures is known from Rushford, thus providing one of ordinary skill a reasonable expectation of success in including the apertures at this density.
Regarding the limitations that the “pouch is adapted to release between 40% to 90% of the one or more caffeine present in the fill material in under 15 minutes” (claim 1 and 28) or 5 to 10 minutes (claim 7), 70 to 90% in under 10 minutes (claim 20), these limitations are met by the pouch that is obvious from the teachings described supra. As described above, it is obvious to form pouches with apertures that allow for passage of saliva and active ingredients while retaining the matrix fill in the pouch, rendering obvious pouch apertures of 400 to 800 μm. As evidenced by the instant specification, the apertures allow for bioactive ingredient to be released faster from matrix material than when there is no aperture ([0025], [0066], [0072], [00118]). Thus, the release rate of the material is a function of the of apertures in the pouch. As the same product of the claims is obvious from the art, namely a pouch comprising caffeine, cannabinoid and coconut coir and having openings/apertures of 400 to 800 μm in the pouch material, the pouch rendered obvious would have the same functional property of being “adapted to release” in the amounts as claimed. Where 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. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977).
Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by the references.
Response to Arguments
Applicant's arguments filed 02 Apr 2026 have been fully considered but they are not persuasive. Applicant argues that the cited references fail to teach or suggest “caffeine in an amount of more than 20% w/w of the fill material, and coconut coir having the caffeine absorbed thereon” (page 8 of remarks). The applicant argues that Mishra, Bruun, Rushforth, Lindsay and Johnson are individually silent regarding these limitations (page 8 of remarks). The examiner is not persuaded and notes that one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). The combined teachings of the prior art render obvious the claimed pouch. Mandel renders obvious pouches with fibrous coconut coir and the inclusion of components such as caffeine and the mixing of an emulsion containing active components with dry components including coconut coir. Coconut coir is an absorbent material (as described in the instant specification [0048]), and when the caffeine component is mixed with the coir component, as is obvious to do, it is expected that it would absorb on the coir material. Even if the art doesn’t use the exact description as the applicant, the art renders obvious the same components combined is such a way that it would meet the limitations of the claim and the applicant has not provided any evidence as to why the art would not result in the same product of the claims. Similarly, even if the art dose not describe the caffeine as more than 20% of the fill material, the art renders obvious a product that meets the limitation. The inclusion of 50-250 mg of caffeine is an obvious amount of caffein for the pouch and 250-800 mg of material in a pouch is also obvious. As described in the rejection, caffeine and pouch material in these amounts renders obvious the more than 20% of caffeine in the pouch as claimed. Thus, even though the art may not describe the caffeine with the exact language of the claims, the product obvious from the art nevertheless meets the limitations.
Applicant argues that Mishra and Bruun cannot be combined to teach the claimed limitations (page 9 of remarks). Applicant argues that Mishra teaches caffeine encapsulated and designed to remain intact until reaching the stomach, and not to be absorbed onto a fibrous carrier like coconut coir (page 9 of remarks). Applicant argues that Bruun describes a pouch designed for oral administration and that the examiners calculation combining Mishra’s 200 mg caffeine with Bruun’s 250-800 mg fill weight ignores that the references address entirely different formulations (page 9 of remarks). Applicant argues that one would not combine Mishra and Bruun with Mandel as this would require fundamentally altering Mishra’s encapsulated caffeine complex (page 10 of remarks). The examiner does not agree with this argument. The inclusion of caffeine is obvious from the teachings of Mandel, which does not require any type of encapsulation. Thus, whether or not the encapsulated caffeine of Mishra could be absorbed on the coir (a point that the examiner does not necessarily agree with as the coir could still take in the encapsulated caffeine) is not persuasive as Mishra is not used for its specific encapsulated caffeine. Instead, Mishra is relied upon for the teaching that 50-200 mg of caffeine is an amount known to provide a consumer with a burst of energy, thus rendering this an obvious amount of caffeine to include. Thus, there is no fundamental altering required of Mishra’s encapsulated caffeine as the encapsulated caffeine is not relied upon. It is obvious to include caffeine from the teachings of Mandel and 50-200 mg is an obvious amount as it can provide an energy burst, as known from Mishra. Thus, the argument regarding a lack of compatibility between the art is not persuasive.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Mandel et al. (US 2019/0060225, Published 28 Feb 2019) in view of Mishra et al. (US 2014/0271791, published 18 Sep 2014), Bruun et al. (WO 2018/233782, published 27 Dec 2018), Rushforth et al. (US 2014/0026912) and Lindsay et al. (US 2018/0125777, published 10 May 2018, included in the IDS filed 20 Jan 2022) and evidenced by the instant specification as applied to claims 1, 4-7, 11, 12, 14, 17, 18, 20, 21, 24, 25, and 27-32 above, and further in view of Johnson et al. (US 2019/0054036, published 21 Feb 2019).
The teachings of Mandel, Mishra, Bruun, Rushforth and Lindsay and are described supra.
Mandel, Mishra, Bruun, Rushforth and Lindsay do not teach an electrospun nanofiber comprising cannabidiol. This deficiency is made up for in the teachings of Johnson.
Johnson teaches electrospun fibers having a pharmaceutical (title). Johnson teaches that electrospinning is one method of fabricating fibers while finely controlling their properties and the amount of substance they include ([0002]). Johnson teaches that the fibers may be formed into a variety of shapes by using a range of receiving surfaces ([0023]). Johnson teaches that the diameter of the fiber is on the nanometer scale and may be referred to as a nanofiber ([0023]). Johnson teaches that the type of polymer may determine the characteristics of the electrospun fiber and that the fibers may degrade or disintegrate at a faster controlled rate, such as a rate appropriate for drug delivery ([0032]).
Johnson teaches that a large percentage of drugs, such as cannabidiol ([0021]), have poor water solubility and there is a need for drug delivery mechanisms capable of improving their bioavailability ([0020]). Johnson teaches that the fibers may comprise an electrospun polymer and a pharmaceutical where the pharmaceutical may be dispersed throughout the fiber ([0003], [0023]). Johnson teaches that the fiber may comprise a CBD (cannabidiol) oil ([0038], [0046]). Johnson teaches that the fibrous scaffold containing cannabidiol may be made from a polymer with desirable degradation rate in vivo and thus make the scaffold a promising candidate for drug delivery ([0047]). Johnson teaches that the fiber may applied in an oral region, a buccal region, or a sublingual region ([0046]).
Therefore, it would have been prima facia obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to have modified the pouch made obvious over Mandel, Mishra, Bruun, Rushforth and Lindsay by incorporating an electrospun nanofiber comprising cannabidiol. One of ordinary skill would be motivated to use the fibers containing cannabidiol as Johnson teaches that the nanofibers may be designed to increase the bioavailability for poorly soluble pharmaceuticals such as cannabidiol and that the fibers may degrade or disintegrate with a controlled rate for appropriate drug delivery. Johnson further teaches that the fiber may be delivered orally and that the fibers may be formed into a variety of shapes, thus giving one of ordinary skill in the art a reasonable expectation of successfully incorporating the electrospun nanofibers into a pouch.Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by the references.
Response to Arguments
Applicant's arguments filed 02 Apr 2026 have been fully considered but they are not persuasive. Applicant argues the limitations of the claim are not met due to its dependence on claim 1 which the art does not render obvious the limitations of 20% caffeine absorbed on coconut coir. These arguments have been addressed in the response to arguments above and the examiner maintains that the claims are obvious for the reasons provided.
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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
The rejections below have been maintained and revised to address new claims 31 and 32.
Claims 1, 3-7, 11, 12, 14, 15, 17, 18 and 20-32 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 of U.S. Patent No. 10,933,016 as evidenced by the instant specification and in view of Mandel et al. (US 2019/0060225, Published 28 Feb 2019), Mishra et al. (US 2014/0271791, published 18 Sep 2014), Bruun et al. (WO 2018/233782, published 27 Dec 2018), Rushforth et al. (US 2014/0026912), Lindsay et al. (US 2018/0125777, published 10 May 2018) and Johnson et al. (US 2019/0054036, published 21 Feb 2019).
Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1-12 and 14 of the ‘016 patent make obvious instant claims 1-20.
Claim 1 recites a product for oral administration of cannabinoids comprising a cannabinoid, including water soluble cannabinoids, a terpene (such as beta caryophyllene), a fibrous carrier (such as coconut coir), a flavoring, a binding agent (such as guar gum), and a pouch.
Claim 2 recites a product for oral administration of cannabinoids comprising a cannabinoid, including water soluble cannabinoids, a terpene (such as beta caryophyllene), a fibrous carrier (such as coconut coir), one or combination of flavorings, one or a combination of binding agents (such as guar gum), one or a combination of emulsifiers and a pouch.
Claim 3 recites a product for oral administration of cannabinoids comprising a cannabinoid, including water soluble cannabinoids, a terpene (such as beta caryophyllene), a fibrous carrier (such as coconut coir), one or a combination of flavorings such as miracle fruit related sweeteners, one or a combination of binding agents (such as guar gum), one or a combination of emulsifiers, one or a combination of vitamins, caffeine, and a pouch of cellulose.
Claims 1-6 of patent ‘016 do not recite that the components are in the pouch with apertures, the size of the apertures, the amount or the release rate of the caffeine from the pouch, the particle size, or where the fill contains electrospun fiber containing cannabinoid.
These are made obvious by Mandel, Mishra, Bruun, Rushforth, Lindsay, and Johnson. The teachings of Mandel, Brun, Rushforth, Lindsay, and Johnson are described supra.
Therefore, it would have been prima facia obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to have 50-250 mg caffeine as this provides energy to the user, as taught by Mishra, and to vary the amount of fill material, for example between 250 to 800 mg, as taught by Bruun. The amount of caffeine obvious to include and the variable fill amount renders obvious the more than 20% caffeine. The inclusion of opening or apertures in the pouch is obvious as this is a method of forming a pouch, as is known from Bruun, Rushforth and Lindsay. Openings/apertures in a pouch allow for the passage of saliva while preventing passage of the matrix material, as taught by Bruun and Lindsay. It additionally would be obvious to have a particle size above 1 micrometer or between 1-1200 micrometers so that particles don’t fall out of the pouch, as taught by Bruun, rendering obvious the particle sizes of the instant claims. It would have been further obvious to have a plurality of apertures having a mean diameter of at least 400 μm and where each aperture has a diameter of at least 100 μm according to Rushforth because Bruun, Lindsay and Rushford teach pouches that retain the material inside the pouches, while permitting release of the active agent. As this is a suitable aperture size for retaining the matrix material while allowing for saliva and active agent transferal, one of ordinary skill would have a reasonable expectation of success in having the openings/apertures with a diameter of at least 400 μm, rendering obvious the aperture size of claims 5, 6 and 29. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). Further, in view of the teachings of Bruun, Lindsay and Rushford that the pouches should be designed to retain the material inside the pouch, specifically with apertures small enough to retain certain material as well as large enough to allow desirable materials to be released and that the particle size of the material in the pouch is variable (e.g 1-1200 μm), the aperture size and particulate size are art-recognized result effective variables such that determining that each of the apertures should have a diameter between 400 to 800 μm and that the coconut coir should be ground to 600-900 μm would be a matter of optimization through routine experimentation. "[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). Thus, it would have been obvious to one of ordinary skill in the art to have formed apertures in the pouch with a diameter of between 400 to 800 μm and coir particle sizes from 600-900 μm through routine experimentation in order to appropriately hold and release desired materials from the pouch. Regarding claim 32, it is obvious to have 16-24 visible apertures per cm2 as this density of apertures is known from Rushford, thus providing one of ordinary skill a reasonable expectation of success in including the apertures at this density.
Regarding the limitations that the “pouch is adapted to release between 40% to 90% of the one or more caffeine present in the fill material in under 15 minutes” (claim 1 and 28) or 5 to 10 minutes (claim 7), 70 to 90% in under 10 minutes (claim 20), these limitations are met by the pouch that is obvious from the teachings described supra. As described above, it is obvious to form pouches with apertures that allow for passage of saliva and active ingredients while retaining the matrix fill in the pouch, rendering obvious pouch apertures of 400 to 800 μm. As evidenced by the instant specification, the apertures allow for bioactive ingredient to be released faster from matrix material than when there is no aperture ([0025], [0066], [0072], [00118]). Thus, the release rate of the material is a function of the of apertures in the pouch. As the same product of the claims is obvious from the art, namely a pouch comprising caffeine, cannabinoid and coconut coir and having openings/apertures of 400 to 800 μm in the pouch material, the pouch rendered obvious would have the same functional property of being “adapted to release” in the amounts as claimed. Where 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. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). One of ordinary skill would further have a reasonable expectation of successfully forming a pouch with electrospun fiber containing cannabidiol as Johnson teaches that cannabidiol may be incorporated into electrospun fibers and used in a form of oral drug delivery.
Claims 1, 3-7, 11, 12, 14, 15, 17, 18 and 20-32 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of U.S. Patent No. 11,534,413 in view of Mandel et al. (US 2019/0060225, Published 28 Feb 2019), Mishra et al. (US 2014/0271791, published 18 Sep 2014), and Bruun et al. (WO 2018/233782, published 27 Dec 2018).
Claim 1 of the ‘413 patent recites a pouch for administration of a cannabinoid, comprising a fibrous matrix material incorporating a plurality of apertures defining a sealed pouch wherein the cannabinoid containing cured filled material comprises at least one of a flavorant, a sweetener, or a stabilizer, wherein the cannabinoid may be cannabidiol, wherein the cured fill material is produced by a process comprising mixing and curing coconut coir together with the cannabinoid extract cannabinoid oil, palm oil and at least one of a flavorant, a sweetener, or a stabilizer for at least 24 hours prior to positioning the cured fill material in the pouch and sealing the pouch; and wherein each of the plurality of apertures is defined by the an aperture size of between about 400 μm to about 800 μm in diameter. Note that there are additional limitations of claim 1 regarding the type of cannabinoid, a curing process for the fill material, the size of the fill material, and the distance between apertures that are all more specific limitations of the pouch that read upon the instant claims.
Claim 2 recites the pouch is adapted to release between 40% to 90% of the cannabinoid present in the fill material in under 10 minutes when placed in a mouth of a user. Claim 3 recites that at least about 50% of the plurality of apertures have the identified size. Claim 4 recites that at least about 90% of the plurality of apertures have the identified size. Claim 5 recites that plurality of apertures is circular in shape and claim 8 recites that the apertures comprise holes extending through the fibrous matrix material. Claim 6 recites that the cannabinoid containing fill material further comprises a terpene and a natural oil and claim 10 specifies that the terpene may be caryophyllene. Claim 7 recites that the fill material comprises a cannabidiol isolate. Claim 11 recites that the cannabinoid containing fill material comprises a blended composition having a total weight. Claim 12 recites a fibrous matrix material of cellulose. Claim 9 recites that the fill material comprises an electrospun nanofiber, wherein the cannabinoid is THC, and the THC is comprised in the electrospun nanofiber. Claims 13 recites an aperture density between 1-100 apertures per cm2.
The claims of patent ‘413 do not recite the inclusion of caffeine or that the terpene is β-caryophyllene, the limitation that the particles have a mean size range of between about 800 μm to 900 μm or 1500-2000 μm, however, these are made obvious over the teachings of Mandel, Mishra and Bruun.
The teachings of Mandel, Mishra and Bruun, are described supra.
Therefore, it would have been prima facia obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to have included 50-250 mg caffeine as this is a known combination, as taught by Mandel, and this amount provides energy to the user, as taught by Bruun. The amount of fill material in the pouch is variable, for example between 250-800 mg, as taught by Bruun, rendering obvious the more than 20% of caffeine in the fill material. It would have been obvious to have substituted the THC as the cannabinoid in the electrospun fiber with cannabidiol, to have used beta caryophyllene as the terpene, to have used coconut coir as a fibrous carrier where the coconut coir has a particle size of above 1 μm or from 1-1200 μm, as these are known parameters suitable for such pouches, as taught by Mandel and Bruun. Additionally, Mandel teaches beta caryophyllene as a suitable terpene and coconut coir as a fibrous carrier for pouches. One of ordinary skill would have a reasonable expectation of success as each of these components have been taught as suitable for oral administration in pouches.
Response to Arguments
Applicant's arguments filed 02 Apr 2026 have been fully considered but they are not persuasive. Applicant argues the limitations of the claims are as the claims are not obvious over Mandel, Mishra and Bruun for the reasons discussed in the 103 rejection above. These arguments have been addressed in the response to arguments above and the examiner maintains that the claims are obvious for the reasons provided.
Conclusion
No claims are 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 extension fee 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 date of this final action.
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/E.C.M./Examiner, Art Unit 1619 /ANNA R FALKOWITZ/Primary Examiner, Art Unit 1600
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