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
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 11 Nov 2025 has been entered.
Response to Amendment
Status of the Claims
Receipt of Applicant’s response, filed 11 Nov 2025 has been entered.
Claims 1, 3-7, 11, 12, 14, 15, 17, 18, 20, 21, 24, 25 and 27-30 remain pending in the application.
Claims 1, 3, 4, 7, 12, 15, 17, 20 and 27 are amended.
Claims 2, 8-10, 13, 16, 19, 22, 23, and 26 are cancelled.
Claims 28-30 are newly added
Claims 1, 3-7, 11, 12, 14, 15, 17, 18, 20, 21, 24, 25, and 27-30 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Objections Withdrawn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The claim objections set forth in the Final Office Action mailed 15 Aug 2025 are hereby withdrawn in light of applicant’s amendments of the claims.
Rejections Withdrawn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pursuant to 35 U.S.C. 112(a), 112(b) and 112(d) set forth in the Final Office Action mailed 15 Aug 2025 are hereby withdrawn in light of applicants amendment of the claims.
Rejections Pursuant to 35 USC § 103
The rejection of claims 1, 3, 4, 7, 11, 12, 14, 17, 18 and 20-27 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 Bruun et al. (WO 2018/233782, published 27 Dec 2018) and Kucuksen et al. (WO 2018/135943 published 26 Jul 2018) and evidenced by the instant specification is withdrawn in light of applicant’s amendment of the claims, and in favor of the new grounds of rejection set forth below.
The rejection of claim 5 and 6 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 Bruun et al. (WO 2018/233782, published 27 Dec 2018) and Kucuksen et al. (WO 2018/135943 published 26 Jul 2018) and evidenced by the instant specification as applied to claims 1, 3, 4, 7, 11, 12, 14, 17, 18 and 20-27 , and further in view of 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) is withdrawn in light of applicant’s amendment of the claims, and in favor of the new grounds of rejection set forth below.
The rejection of claim 15 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 Bruun et al. (WO 2018/233782, published 27 Dec 2018) and Kucuksen et al. (WO 2018/135943 published 26 Jul 2018) and evidenced by the instant specification as applied to claims 1, 3, 4, 7, 11, 12, 14, 17, 18 and 20-27 , and further in view of Johnson et al. (US 2019/0054036, published 21 Feb 2019) is withdrawn in light of applicant’s amendment of the claims, and in favor of the new grounds of rejection set forth below.
Rejections Pursuant to Double Patenting
The rejections under double patenting over U.S. Patent No. 10,933,016 and 11,534,413 are withdrawn in light of applicant’s amendment of the claims and the double patenting rejections are reapplied below.
New Grounds of Objections/Rejections
Claim Objections
Claims 4 and 27 are objected to because of the following informalities:
Claim 4 recites “further comprise” but this should be “further comprises.”
Claim 27 recites “comprising” in the second to last line but this would be improved as “comprises.”
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1, 3, 4-7, 11, 14, 15, 17, 18, 24 and 25 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 is indefinite for the recitation from the third line from the bottom of “the one or more caffeine” for lacking proper antecedent basis. The caffeine in the claim is not previously referred to as the “one or more caffeine” and it is not clear if the “one or more caffeine” is intended to refer to the same caffeine already recited in the claim or if it refers to an alternative caffeine. Claims 3, 4-7, 11, 14, 15, 17, 18, 24 and 25 are included in this rejection as they depend directly, indirectly, or include all the limitations of independent claim 1.
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, 4-7, 11, 12, 14, 17, 18, 20, 21, 24, 25, and 27-30 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) 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]).
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 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. 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, the aperture size is an art-recognized result effective variable such that determining that each of the apertures should have a diameter between 400 to 800 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 through routine experimentation in order to appropriately hold and release desired materials from the pouch.
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 11 Nov 2025 have been fully considered but they are not persuasive. Applicant states that the rejection did not provide rational as to how one of ordinary skill would arrive at the instant invention. The examiner notes that the previous rejection has been modified in light of the applicant’s amendments and that the applied rejection provides a prima facie case of obviousness over the instant claims, as described in the rejection above.
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, 3, 4-7, 11, 12, 14, 17, 18, 20, 21, 24, 25, and 27-30 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.
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.
Claims 1, 3-7, 11, 12, 14, 15, 17, 18 and 20-27 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 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, the aperture size is an art-recognized result effective variable such that determining that each of the apertures should have a diameter between 400 to 800 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 through routine experimentation in order to appropriately hold and release desired materials from the pouch.
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 20-27 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 cannabinboid is THC, and the THC is comprised in the electrospun nanofiber.
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, 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.
Claims 1, 3-7, 11, 12, 14, 15, 17, 18 and 20-27 are directed to an invention not patentably distinct from claims 1-6 of commonly assigned U.S. Patent No. 10,933,016. Specifically, see above.
The U.S. Patent and Trademark Office may not institute a derivation proceeding in the absence of a timely filed petition. The USPTO normally will not institute a derivation proceeding between applications or a patent and an application having common ownership (see 37 CFR 42.411). Commonly assigned U.S. Patent No. 10,933,016, discussed above, would be prior art to the noted claims under 35 U.S.C. 102(a)(2) if the patentably indistinct inventions were not commonly owned or deemed to be commonly owned as of the effective filing date under 35 U.S.C. 100(i) of the claimed invention.
In order for the examiner to resolve this issue the applicant or patent owner can provide a statement under 35 U.S.C. 102(b)(2)(C) and 37 CFR 1.104(c)(4)(i) to the effect that the subject matter and the claimed invention, not later than the effective filing date of the claimed invention, were owned by the same person or subject to an obligation of assignment to the same person. Alternatively, the applicant or patent owner can provide a statement under 35 U.S.C. 102(c) and 37 CFR 1.104(c)(4)(ii) to the effect that the subject matter was developed and the claimed invention was made by or on behalf of one or more parties to a joint research agreement that was in effect on or before the effective filing date of the claimed invention, and the claimed invention was made as a result of activities undertaken within the scope of the joint research agreement; the application must also be amended to disclose the names of the parties to the joint research agreement.
A showing that the inventions were commonly owned or deemed to be commonly owned as of the effective filing date under 35 U.S.C. 100(i) of the claimed invention will preclude a rejection under 35 U.S.C. 102 or 103 based upon the commonly assigned case. Alternatively, applicant may take action to amend or cancel claims such that the applications, or the patent and the application, no longer contain claims directed to patentably indistinct inventions.
Response to Arguments
Applicant's arguments filed 11 Nov 2025 have been fully considered. Applicant states that a terminal disclaimer was filed to overcome the rejections, however, a terminal disclaimer has not been submitted.
Conclusion
No claim is allowed.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to EDWIN C MITCHELL whose telephone number is (571)272-7007. The examiner can normally be reached Mon-Fri 8:00-5:00.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David Blanchard can be reached on (571)272-0827. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/E.C.M./Examiner, Art Unit 1619
/BENNETT M CELSA/Quality Assurance Specialist , Art Unit 1600