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 .
Election/Restrictions
Applicant’s election without traverse of Group I (claims 1-8 and 14) in the reply filed on 6/30/2026 is acknowledged.
Claims 9-13 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 6/30/2026.
Information Disclosure Statement
Examiner would like to note that citation AE on the IDS filed 5/22/2024 to US Patent No. 9,750,722 is listed as a patent by Gushchin et al. but corresponds to a patent by Chen.
US Patent No. 9,750,727 (Gushchin et al.) has been considered in lieu of US Patent No. 9,750,722.
Specification
The use of the term POLYPLASDONE XL-10, which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore, the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
The specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-2, 4 and 14 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Bruun et al. (US 2023/0218512 A1, effectively filed 12/13/2019, cited on the 5/22/2024 IDS), as evidenced by Vanhoorne et al. (2016).
Examiner would like to note that the instant recitation of “beverage” in the preamble is
is interpreted as intended use and does not constitute a functional limitation. If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction. MPEP 2111.02. In the instant case, the preamble does not add a structural distinction to the claim. As the prior art anticipates the claimed structure, the limitations of the claims have been met.
Regarding claims 1-2, 4, and 14, Bruun teaches a fast-disintegrating tablet comprising 39.6% mannitol (reads on sugar alcohol), 5% crospovidone (i.e. crosslinked polyvinylpyrrolidone or cPVP, reads on superdisintegrant), 39.6% microcrystalline cellulose (reads on binder), 10% CBD (reads on psychoactive cannabinoid), and 1% magnesium stearate (reads on lubricant, see para. 0177) [Table 9, Example FDT(d)]. Exemplary Tablet FDT(d) has a mean maximum dissolution time of 177 seconds (i.e. disintegrates in less than 10 minutes) and a mean hardness of at least 19 N, which equals 1.937 kP [Table 16]. Bruun does not explicitly designate microcrystalline cellulose (MCC) as a binder, however, a chemical composition and its properties are inseparable, and MCC is known to be a dry binder in tablet formulations (see instant Specification at pg. 5). As evidenced by Vanhoorne et al., MCC is less soluble than D-mannitol [Abstract]. Regarding the recitation of “tested according to the Tablet Disintegration Test Method”, the U.S. Patent Office is not equipped with analytical instruments to test prior art compositions for the infinite number of ways that a subsequent applicant may present previously unmeasured characteristics. When as here, the prior art appears to contain the exact same ingredients and applicant's own disclosure supports the suitability of the prior art composition as the inventive composition component, the burden is properly shifted to applicant to show otherwise.
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 1-7 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Bruun et al. (US 2023/0218512 A1, effectively filed 12/13/2019, cited on the 5/22/2024 IDS), as evidenced by Vanhoorne et al. (2016).
Examiner would like to note that the instant recitation of “beverage” in the preamble is
is interpreted as intended use and does not constitute a functional limitation. If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction. MPEP 2111.02. In the instant case, the preamble does not add a structural distinction to the claim. As the prior art makes obvious the claimed structure, the limitations of the claims have been met.
Regarding claims 1-2, 4 and 14, Bruun teaches a fast-disintegrating tablet comprising 39.6% mannitol (reads on sugar alcohol), 5% crospovidone (i.e. crosslinked polyvinylpyrrolidone, reads on superdisintegrant), 39.6% microcrystalline cellulose (reads on binder), 10% CBD (reads on psychoactive cannabinoid), and 1% magnesium stearate (reads on lubricant, see para. 0177) [Table 9, Example FDT(d)]. Exemplary Tablet FDT(d) has a mean maximum dissolution time of 177 seconds (i.e. disintegrates in less than 10 minutes) and a mean hardness of at least 19 N, which equals 1.937 kP [Table 16]. Bruun does not explicitly designate microcrystalline cellulose (MCC) as a binder, however, a chemical composition and its properties are inseparable, and MCC is shown to be a suitable dry binder in tablet formulations (see instant Specification at pg. 5). As evidenced by Vanhoorne et al., MCC is less soluble than D-mannitol [Abstract]. Regarding the recitation of “tested according to the Tablet Disintegration Test Method”, the U.S. Patent Office is not equipped with analytical instruments to test prior art compositions for the infinite number of ways that a subsequent applicant may present previously unmeasured characteristics. When as here, the prior art appears to contain the exact same ingredients and applicant's own disclosure supports the suitability of the prior art composition as the inventive composition component, the burden is properly shifted to applicant to show otherwise.
Regarding claim 3, Bruun teaches that the fast-disintegrating tablet may comprise of sugar alcohols, including mannitol [0053], and may further comprise of inulin [0081]. Bruun does not explicitly designate inulin as a binder, however, a chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. MPEP 2112.01.
Regarding claim 5, claim 5 depends from claim 3 above, and further recites the limitation wherein the superdisintegrant comprises cPVP. Bruun teaches crospovidone (i.e. cPVP) as a superdisintegrant [0042].
Regarding claims 6-7, Bruun teaches Exemplary Tablet FDT(d), which comprises 39.6% mannitol, 5% crospovidone, 39.6% microcrystalline cellulose, 10% CBD, and 1% magnesium stearate [Table 9, Example FDT(d)].The amounts of mannitol and cPVP taught by Bruun fall within and make obvious the instantly claimed ranges of sugar alcohol/mannitol and superdisintegrant/cPVP. See MPEP 2131.03. Bruun does not explicitly teach a range for binders, however, as discussed previously, MCC is widely known and used as a binder in tablet formulation. Bruun provides various examples in which MCC is taught in amounts ranging from 5% up to 43% [see Tables 12 and 13]. The amounts taught in the prior art overlap with the instantly claimed ranges, thus a prima facie case of obviousness exists. MPEP 2144.05
Claims 6-7 are rejected under 35 U.S.C. 103 as being unpatentable over Bruun et al. (US 2023/0218512 A1, effectively filed 12/13/2019, cited on the 5/22/2024 IDS) as applied to claim 1 above, and further in view of Divi et al. (WO 03/086361 A1, published 10/23/2003).
Regarding claims 6 and 7, Bruun teaches a fast-disintegrating tablet comprising 39.6% mannitol and 5% crospovidone as discussed above [Table 9, Example FDT(d)]. Bruun teaches that the tablet may comprise of a binder [claim 12], but does not explicitly teach the amounts in which the binder may be present. Divi teaches a solid drug tablet that rapidly disperses in water [Abstract; pg. 3]. The tablet of Divi comprises at least one binder in the amount of 2% to 10% [claim 1]. It would be obvious to one of ordinary skill in the art to modify the teachings of Bruun with that of Divi to include a binder in the amount that binders are taught to be suitable in. However, Examiner would like to note that differences in concentration will generally not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration is critical. MPEP 2144.05.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Bruun et al. (US 2023/0218512 A1, effectively filed 12/13/2019, cited on the 5/22/2024 IDS) and Divi et al. (WO 03/086361 A1, published 10/23/2003), as applied to claims 1 and 6-7 above, and further in view of van Dijk et al. (US 2002/0192278 A1, published 12/19/2002, cited on the 5/22/2024 IDS).
Regarding claim 8, this claim recites limitations that have been previously addressed and made obvious. The analysis for these limitations will not be repeated herein. Claim 8 recites the further limitation wherein the beverage tablet comprises from 5% to 30% by weight of inulin. (As discussed, the teachings of Bruun in view of Divi make obvious a tablet wherein the binder comprises from 5% to 30% by weight.) Bruun teaches that the tablet may comprise of inulin [0081], but does not explicitly teach inulin as a binder. As evidenced by van Dijk, inulin is a particularly suitable filler-binder (reads on binder) for tablets [0012-0014] due to its good physical stability and inert nature [0016]. Thus, it would be obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the teachings of Bruun with that of Divi and van Dijk to arrive at a tablet wherein the binder comprised of 5% to 30% inulin. It would be obvious to select inulin as a binder for its aforementioned properties, and to use a binder in the amount that binders are taught to be suitable in.
Conclusion
No claims are allowed.
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/AMANDA LYNN CHI/Examiner, Art Unit 1613
/JENNIFER A BERRIOS/ Primary Examiner, Art Unit 1613
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