DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Status
Applicant’s remarks and amendments, filed 30 March 2026 in response to the non-final rejection mailed 29 December 2025, are acknowledged and have been fully considered. Applicant’s amendments to the claims are acknowledged. The listing of claims filed 30 March 2026 replaces all prior versions and listings of the claims.
Claims 1-5, 7-9, 11, and 14-17 are pending. Claims 6 and 10 are canceled by Applicant’s amendment. Claims 11, 14, and 16 remain withdrawn. Claims 1, 7, 11, and 15 are amended. Claims 1-5, 7-9, 15, and 17 are being examined on the merits.
Response to Amendment
Any previous rejection or objection not mentioned herein is withdrawn.
Applicant’s amendment to Claim 15 has overcome the claim objection in regards to minor informalities. The objection to Claim 15 has thus been withdrawn.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-5, 7-9, 15, and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Finley et al. (WO 2017/091764 A1) in view of Melnychuk (Palo Alto Homeopathy, 2005, 7 pages) and Taha (US 2016/0051480 A1).
The instant claims are as of record, drawn to cannabinoid loaded granules consisting of neutral homeopathic orodispersible sugar granules loaded with at least one cannabinoid compound, wherein said granules have a circular shape and a diameter of about 2-10 millimeters, wherein said cannabinoid loaded granules are impregnated or sugar-coated with a sugar syrup and an extract containing at least one cannabinoid compound, and wherein said loaded granules are further coated with a sugar syrup comprising a coloring agent, flavoring agent, natural gum, natural wax, or any combination thereof.
Finley et al. teach cannabis oils (extracts) comprising cannabinoids (cannabinoid compound) including cannabigerol, CBD, and THC, wherein the cannabinoid is present in an amount ranging from about 0.001% to about 99% by weight, (Finley et al., [0135]-[0137], pages 27-33; as required for instant Claims 1, 4, 7). The at least one cannabinoid of the instant specification lines may be “under a purified form comprising at least 90% of said cannabinoid in weight” and may be in the form of an oil (page 9, lines 28-32), thus the cannabinoid oil of Finley et al. is analogous to the cannabinoid of the instant claims.
The cannabis oil is derived from extraction of Cannabis sativa plants (natural; Finley et al., [0052], page 7; as required for instant Claims 5 and 7) and oils generally contain at least one terpene compound (Finley et al., [0151], page 40; as required for instant Claim 9). Additionally, the cannabis oil is administered in doses ranging from 1-2000 mg of cannabis oil, and thus, for example, a 10 mg dose of cannabinoid oil comprising 99% cannabinoid would have a dose of 9.9 mg of cannabinoid (Finley et al., [0194], page 81; as required for instant Claim 8). The overall possible range of cannabinoid present in the cannabis oil would thus be 0.00001-1980 mg of cannabinoid, which overlaps the ranges of instant Claims 8 and 17.
Finley et al. does not teach neutral homeopathic orodispersible sugar granules, wherein the granules are coated with a sugar syrup and an extract containing at least one cannabinoid compound, or wherein the granules are coated with a sugar syrup comprising a color or flavoring agent, natural gum, natural wax, or any combination thereof
Melnychuk, however, teaches that homeopathic remedies are commonly supplied in the form of 2.0-3.5 mm diameter solid round globules (circular shape) made of sucrose (saccharose) and lactose, sucrose (saccharose), or xylitol (neutral homeopathic sugar granules; Melnychuk, page 2; as required for instant Claims 1-3). Additionally, the remedies are administered orally (orodispersible; Melnychuk, page 3; as required for instant Claim 1).
Taha teaches an orally-deliverable tablet comprising an outer coating having cannabinoid and an inner core having one or more active pharmaceutical ingredients substantially encapsulated by the outer coating. Tablet coatings, including sugar (sugar coated; sugar syrup), polysaccharides (natural gum), pigments (coloring agent; Taha, [0022], page 2; as required for instant Claims 6 and 10), and cannabidiol (Taha, [0023], page 2; as required for instant Claim 6) can be used in order to improve taste, allow for timed release, and provide functional properties.
While Finley et al., Melnychuk, and Taha do not explicitly teach that the granules are impregnated or cannabinoid-loaded, it would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the instant application to provide the cannabis oil or Finley et al. using the neutral homeopathic orodispersible sugar globules of Melnychuk. The sugar globules are a common way to provide homeopathic remedies and it would be obvious to a skilled artisan to instead provide a cannabinoid-containing cannabis oil using the common homeopathic dosage form of globules (e.g., impregnate with cannabis oil) due to the various positive effects of cannabinoids such as pain relief, aiding sleep, bacterial inhibition, reduce the symptoms of cancer, epilepsy, autoimmune disease, neurodegeneration, Alzheimer’s disease, Lyme disease, post-traumatic stress disorder, inflammation, and provide therapeutic effects in patients with glaucoma, dysmenorrhea, migraines, and anxiety disorders (Finley et al., [0003], page 2). Since the cannabinoid-containing oil of Finley et al. can be provided in the form of a tablet comprising the active ingredient and a filler such as sucrose ([0190], page 79), a skilled artisan could therefore select the homeopathic globule of Melnychuk as a mode of administration with a reasonable expectation of success. It also would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the instant application to coat the granule in order to improve the taste (Taha, [0022], page 2) while also providing the functional properties of cannabinoids (Taha, [0023], page 2). A skilled artisan would also be motivated to provide a coating comprising a cannabinoid because the fibers of cannabinoids are strong, versatile, and malleable (Taha, [0025], page 2). A skilled artisan could therefore produce the claimed cannabinoid-loaded granules comprising sugar and cannabinoid coatings with a reasonable expectation of success. Finally, since the combination of Finley et el. and Melnychuk teach the composition of Claim 1, the teaching of the prior art is therefore also drawn to the nutritional complement of instant Claim 15. Thus, the preamble of the claim is not considered a limitation and is of no significance to claim construction. See MPEP § 2111.02.
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
Please note, since the Office does not have the facilities for examining and comparing Applicants’ composition with the composition of the prior art, the burden is on applicant to show a novel or unobvious difference between the claimed product and the product of the prior art. See In re Best, 562 F.2d 1252, 195 USPQ 430 (CCPA 1977) and In re Fitzgerald, 619 F.2d 67, 205 USPQ 594 (CCPA 1980), and “as a practical matter, the Patent Office is not equipped to manufacture products by the myriad of processes put before it and then obtain prior art products and make physical comparisons therewith.” In re Brown, 459 F.2d 531, 535, 173 USPQ 685,
688 (CCPA 1972).
Response to Arguments
Applicant's arguments filed 30 March 2026 have been fully considered but they are not persuasive.
Applicant argues that loading lipophilic compounds onto hydrophilic sugar granules would not be efficient, that homeopathic granules when used in homeopathic remedies are loaded with small amounts of active compounds, and that homeopathic granules are friable and fragile, therefore combination of the references would not be obvious due to these technical problems.
This argument is not persuasive, however, because the amount of homeopathic tincture loaded onto granules does not preclude one of skill in the art from adding a larger amount of a different compound with differing known effective doses. Additionally, it is noted that while Finley et al. do not explicitly teach homeopathic sugar granules, they do disclose that the cannabinoid oil can be provided in the form of a tablet comprising the active ingredient and a filler such as sucrose ([0190], page 79), indicating that even if, as applicant claims, the combination of lipophilic cannabinoid oil with hydrophilic sugar tablets would not be efficient, it is still disclosed in the art. Finally, since homeopathic sugar granules are friable and fragile, a skilled artisan would be further motivated to provide the cannabinoid coating of Taha as the coating of an extract containing a cannabinoid of instant Claim 1 due to the fibers of cannabinoids being strong, versatile, and malleable, which would counter the fragility of the sugar granules.
Applicant additionally argues that because the instantly claimed invention was not achieved by late 2017 after the publication of Finley et al., the invention cannot be obvious. Contentions that the reference patents are old are not impressive absent a showing that the art tried and failed to solve the same problem notwithstanding its presumed knowledge of the references. See In re Wright, 569 F.2d 1124, 193 USPQ 332 (CCPA 1977).
Applicant also notes that the “cannabinoids” of Taha refer to a cannabinoid extract which is used as a coating material rather than an active compound, however the instant claim does not refer to an active compound and instead refers to a sugar granule which is loaded with cannabinoid, coated with a sugar syrup and with an extract containing a cannabinoid (e.g., the cannabinoid coating of Taha), and then additionally coated with a sugar syrup comprising a coloring agent, flavoring agent, natural gum, natural wax, or any combination thereof. Applicant goes on to argue that coating homeopathic globules - e.g., sugar in the shape of a globe - had never been disclosed or suggested in the cited art, however it would have been obvious to a person of ordinary skill in the art to provide a coating in order to in order to improve taste, allow for timed release, and provide functional properties, similarly to the tablets or pills (e.g., homeopathic globules are also known as pellets, pillules, or pills, see Melnychuk, “Different name, same thing,” page 2).
Additionally, it would have been obvious to a skilled artisan to also provide the cannabinoid coating of Taha as the coating of an extract containing a cannabinoid of instant Claim 1 due to the fibers of cannabinoids being strong, versatile, and malleable (e.g., strength provides stability). Finally, applicant notes that Taha does not specifically mention “sugar syrup,” however in the field of sugar coating pills (e.g., the pill coating field of Taha), it is known that “sugar coating” refers to a well-known pharmaceutical coating technique wherein sucrose-based compounds are deposited via aqueous solutions (e.g., sugar syrup), as evidenced by Shechter (Pion, 2015, pages 2-3).
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., improved stability, aesthetic appeal, fixation of cannabinoid onto the granule, protection from breakage) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
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 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.
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/J.L.C./Examiner, Art Unit 1655
/AARON J KOSAR/Primary Examiner, Art Unit 1655
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