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 .
Priority
The instant application claims foreign priority to DKPA202070298 filed 05/08/2020. The instant application is a CON of 17/245,179 filed 04/30/2021.
Information Disclosure Statement
The information disclosure statements (IDS) dated 02/06/2025, 06/16/2025, and 07/25/2025 all comply with provisions of 37 CFR 1.97, 1.98 and MPEP §609. Accordingly, they have been placed in the application file and the information therein has been considered as to the merits.
Claim Interpretation
With regards to components followed by parenthetical descriptors in claims 1-30 examples including directly compressible (DC) or cetyl pyridinium chloride (CPC), the Examiner understands that these are common alternate names or short-hand for the compound in question and not a narrower or more specific subset of a general compound. As such, the combination is not considered a broad limitation followed by a narrower limitation.
The term “both being present in an amount of at least 20%”, in claims 21 and 22 is being interpreted as the combination of the two sugar alcohols being present in an amount of at least 20%.
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 21 and 22 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 21 recites “The powder mixture according to claim 1, wherein the at least two types of sugar alcohol particles being both present in an amount of at least 20% by weight of the powder mixture” it is presently unclear if each sugar alcohol is at least 20% or if the combination of the sugar alcohols is at least 20%.
Claim 22 recites “The powder mixture according to claim 1, wherein i) and ii) being both present in an amount of at least 20% by weight of the powder mixture.” it is presently unclear if each sugar alcohol is at least 20% or if the combination of the sugar alcohols is at least 20%.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
I) Claims 1-22, 24 and 28-30 are rejected under 35 U.S.C. 103 as being unpatentable over Turner et al (US Patent Publication 2016/0263170 A1).
Turner teaches a composition with at least two sugar alcohol particles (Turner at claim 1) with a multimodal particle size distribution (Turner at claim 2) wherein the sugar alcohols are erythritol, lactitol, maltitol, mannitol, sorbitol, xylitol, or combinations thereof (Turner at claim 9). Turner further teaches that the composition may be used mouthwashes (Turner at [0066]). Turner et al. teaches that a free-flowing composition has a Hausner ratio of less than 1.5 [ Hausner at 0034]. The range of Hausner ratios provided by Turner overlaps with the instantly claimed ranges of Hausner ratios. Turner teaches the repressive sweetener composition formulated to have a mean particle size distribution ranging from about 200 microns to about 700 microns (Turner at [0082]). Turner teaches the sugar alcohols are present in a combined amount of from about 20 wt. % to about 80 wt. %, alternatively from about 30 wt. % to about 70 wt. %, or alternatively from about 38 wt. % to about 60 wt. % based on the total weight of the composition (Turner at [0018]). Turner teaches that the composition may be a component of a treatment for the prevention or reduction of dental caries. Caries is a multi-factorial disease that involves prolonged colonization of acid-producing bacteria on teeth. Fermentation of dietary carbohydrates by caries leads to a localized drop in pH below a critical value of 5.5, resulting in the demineralization of enamel and potentially damaging underlying tooth structure. If left untreated, caries can lead to the progressive destruction of tooth structure, pain, tooth loss, loss of oral function, as well as have systemic health consequences. In an embodiment, an NSC of the type disclosed herein is a component of a regimen designed to reduce the incidence of dental caries in a subject (Turner at [0073]).
Turner differs from the instant claims in this rejection insofar as it does not teach the combination of the instantly recited components with sufficient specificity for anticipation. Turner teaches the components of the instant recited composition and uses each component of their established function in the art but does not explicitly combine the components together into a single embodiment or a preferred composition. However, given the disclosure of each component individually, it would have been prima facie obvious to a person having ordinary skill in the art at a time prior to the filing of the present patent application and following the teachings of Turner to have selected and combined known components for their established functions with predictable results. MPEP §2143 and §2144.06(I).
Regarding instant claim 1, Turner teaches a composition with at least two sugar alcohol particles (Turner at claim 1) with a multimodal particle size distribution (Turner at claim 2) wherein the sugar alcohols are erythritol, lactitol, maltitol, mannitol, sorbitol, xylitol, or combinations thereof (Turner at claim 9). Turner further teaches that the composition may be used mouthwashes (Turner at [0066]). Turner et al. teaches that a free-flowing composition has a Hausner ratio of less than 1.5 (Turner at [0034]). The range of Hausner ratios provided by Turner overlaps with the instantly claimed ranges of Hausner ratios. See MPEP §2144.05(I) stating that where claimed ranges overlap with prior art ranges, a prima facie case of obviousness exists. Turner teaches the repressive sweetener composition formulated to have a mean particle size distribution ranging from about 200 microns to about 700 microns (Turner at [0082]). The range of particle size provided by Turner overlaps with the instantly claimed ranges. See MPEP §2144.05(I) stating that where claimed ranges overlap with prior art ranges, a prima facie case of obviousness exists. Turner teaches the sugar alcohols are present in a combined amount of from about 20 wt. % to about 80 wt. %, alternatively from about 30 wt. % to about 70 wt. %, or alternatively from about 38 wt. % to about 60 wt. % based on the total weight of the composition (Turner at [0018]). The range of sugar alcohol particles provided by Turner overlaps with the instantly claimed ranges. See MPEP §2144.05(I) stating that where claimed ranges overlap with prior art ranges, a prima facie case of obviousness exists.
Regarding instant claim 2, Turner teaches the repressive sweetener composition formulated to have a mean particle size distribution ranging from about 200 microns to about 700 microns (Turner at [0082]). The range of particle size provided by Turner overlaps with the instantly claimed ranges. See MPEP §2144.05(I) stating that where claimed ranges overlap with prior art ranges, a prima facie case of obviousness exists.
Regarding instant claim 3, Turner teaches the repressive sweetener composition formulated to have a mean particle size distribution ranging from about 200 microns to about 700 microns (Turner at [0082]). The range of particle size provided by Turner overlaps with the instantly claimed ranges. See MPEP §2144.05(I) stating that where claimed ranges overlap with prior art ranges, a prima facie case of obviousness exists. Turner teaches the sugar alcohols are present in a combined amount of from about 20 wt. % to about 80 wt. %, alternatively from about 30 wt. % to about 70 wt. %, or alternatively from about 38 wt. % to about 60 wt. % based on the total weight of the composition (Turner at [0018]). The range of sugar alcohol particles provided by Turner overlaps with the instantly claimed ranges. See MPEP §2144.05(I) stating that where claimed ranges overlap with prior art ranges, a prima facie case of obviousness exists.
Regarding instant claim 4, Turner teaches a composition with at least two sugar alcohol particles (Turner at claim 1) with a multimodal particle size distribution (Turner at claim 2) wherein the sugar alcohols are erythritol, lactitol, maltitol, mannitol, sorbitol, xylitol, or combinations thereof (Turner at claim 9).Turner teaches the repressive sweetener composition formulated to have a mean particle size distribution ranging from about 200 microns to about 700 microns (Turner at [0082]). The range of particle size provided by Turner overlaps with the instantly claimed ranges. See MPEP §2144.05(I) stating that where claimed ranges overlap with prior art ranges, a prima facie case of obviousness exists. Turner teaches the sugar alcohols are present in a combined amount of from about 20 wt. % to about 80 wt. %, alternatively from about 30 wt. % to about 70 wt. %, or alternatively from about 38 wt. % to about 60 wt. % based on the total weight of the composition (Turner at [0018]). The range of sugar alcohol particles provided by Turner overlaps with the instantly claimed ranges. See MPEP §2144.05(I) stating that where claimed ranges overlap with prior art ranges, a prima facie case of obviousness exists.
Regarding instant claim 5, Turner teaches a composition with at least two sugar alcohol particles (Turner at claim 1) with a multimodal particle size distribution (Turner at claim 2) wherein the sugar alcohols are erythritol, lactitol, maltitol, mannitol, sorbitol, xylitol, or combinations thereof (Turner at claim 9).
Regarding instant claim 6, Turner teaches a composition with at least two sugar alcohol particles (Turner at claim 1) with a multimodal particle size distribution (Turner at claim 2) wherein the sugar alcohols are erythritol, lactitol, maltitol, mannitol, sorbitol, xylitol, or combinations thereof (Turner at claim 9). Turner teaches the repressive sweetener composition formulated to have a mean particle size distribution ranging from about 200 microns to about 700 microns (Turner at [0082]). The range of particle size provided by Turner overlaps with the instantly claimed ranges. See MPEP §2144.05(I) stating that where claimed ranges overlap with prior art ranges, a prima facie case of obviousness exists.
Regarding instant claim 7, Turner teaches a composition with at least two sugar alcohol particles (Turner at claim 1) with a multimodal particle size distribution (Turner at claim 2) wherein the sugar alcohols are erythritol, lactitol, maltitol, mannitol, sorbitol, xylitol, or combinations thereof (Turner at claim 9). Turner teaches the repressive sweetener composition formulated to have a mean particle size distribution ranging from about 200 microns to about 700 microns (Turner at [0082]). The range of particle size provided by Turner overlaps with the instantly claimed ranges. See MPEP §2144.05(I) stating that where claimed ranges overlap with prior art ranges, a prima facie case of obviousness exists. Turner teaches the sugar alcohols are present in a combined amount of from about 20 wt. % to about 80 wt. %, alternatively from about 30 wt. % to about 70 wt. %, or alternatively from about 38 wt. % to about 60 wt. % based on the total weight of the composition (Turner at [0018]). The range of sugar alcohol particles provided by Turner overlaps with the instantly claimed ranges. See MPEP §2144.05(I) stating that where claimed ranges overlap with prior art ranges, a prima facie case of obviousness exists.
Regarding instant claim 8, Turner teaches a composition with at least two sugar alcohol particles (Turner at claim 1) with a multimodal particle size distribution (Turner at claim 2) wherein the sugar alcohols are erythritol, lactitol, maltitol, mannitol, sorbitol, xylitol, or combinations thereof (Turner at claim 9). Turner teaches the repressive sweetener composition formulated to have a mean particle size distribution ranging from about 200 microns to about 700 microns (Turner at [0082]). The range of particle size provided by Turner overlaps with the instantly claimed ranges. See MPEP §2144.05(I) stating that where claimed ranges overlap with prior art ranges, a prima facie case of obviousness exists. Turner teaches the sugar alcohols are present in a combined amount of from about 20 wt. % to about 80 wt. %, alternatively from about 30 wt. % to about 70 wt. %, or alternatively from about 38 wt. % to about 60 wt. % based on the total weight of the composition (Turner at [0018]). The range of sugar alcohol particles provided by Turner overlaps with the instantly claimed ranges. See MPEP §2144.05(I) stating that where claimed ranges overlap with prior art ranges, a prima facie case of obviousness exists.
Regarding instant claim 9, Turner teaches a composition with at least two sugar alcohol particles (Turner at claim 1) with a multimodal particle size distribution (Turner at claim 2) wherein the sugar alcohols are erythritol, lactitol, maltitol, mannitol, sorbitol, xylitol, or combinations thereof (Turner at claim 9).
Regarding instant claim 10, Turner teaches a composition with at least two sugar alcohol particles (Turner at claim 1) with a multimodal particle size distribution (Turner at claim 2) wherein the sugar alcohols are erythritol, lactitol, maltitol, mannitol, sorbitol, xylitol, or combinations thereof (Turner at claim 9). Turner teaches the repressive sweetener composition formulated to have a mean particle size distribution ranging from about 200 microns to about 700 microns (Turner at [0082]). The range of particle size provided by Turner overlaps with the instantly claimed ranges. See MPEP §2144.05(I) stating that where claimed ranges overlap with prior art ranges, a prima facie case of obviousness exists.
Regarding instant claim 11, Turner teaches a composition with at least two sugar alcohol particles (Turner at claim 1) with a multimodal particle size distribution (Turner at claim 2) wherein the sugar alcohols are erythritol, lactitol, maltitol, mannitol, sorbitol, xylitol, or combinations thereof (Turner at claim 9). Turner teaches the repressive sweetener composition formulated to have a mean particle size distribution ranging from about 200 microns to about 700 microns (Turner at [0082]). The range of particle size provided by Turner overlaps with the instantly claimed ranges. See MPEP §2144.05(I) stating that where claimed ranges overlap with prior art ranges, a prima facie case of obviousness exists. Turner teaches the sugar alcohols are present in a combined amount of from about 20 wt. % to about 80 wt. %, alternatively from about 30 wt. % to about 70 wt. %, or alternatively from about 38 wt. % to about 60 wt. % based on the total weight of the composition (Turner at [0018]). The range of sugar alcohol particles provided by Turner overlaps with the instantly claimed ranges. See MPEP §2144.05(I) stating that where claimed ranges overlap with prior art ranges, a prima facie case of obviousness exists.
Regarding instant claim 12, Turner teaches a composition with at least two sugar alcohol particles (Turner at claim 1) with a multimodal particle size distribution (Turner at claim 2) wherein the sugar alcohols are erythritol, lactitol, maltitol, mannitol, sorbitol, xylitol, or combinations thereof (Turner at claim 9). Turner teaches the repressive sweetener composition formulated to have a mean particle size distribution ranging from about 200 microns to about 700 microns (Turner at [0082]). The range of particle size provided by Turner overlaps with the instantly claimed ranges. See MPEP §2144.05(I) stating that where claimed ranges overlap with prior art ranges, a prima facie case of obviousness exists. Turner teaches the sugar alcohols are present in a combined amount of from about 20 wt. % to about 80 wt. %, alternatively from about 30 wt. % to about 70 wt. %, or alternatively from about 38 wt. % to about 60 wt. % based on the total weight of the composition (Turner at [0018]). The range of sugar alcohol particles provided by Turner overlaps with the instantly claimed ranges. See MPEP §2144.05(I) stating that where claimed ranges overlap with prior art ranges, a prima facie case of obviousness exists.
Regarding instant claim 13, Turner teaches the repressive sweetener composition formulated to have a mean particle size distribution ranging from about 200 microns to about 700 microns (Turner at [0082]). The range of particle size provided by Turner overlaps with the instantly claimed ranges. See MPEP §2144.05(I) stating that where claimed ranges overlap with prior art ranges, a prima facie case of obviousness exists.
Regarding instant claim 14, Turner teaches a composition with at least two sugar alcohol particles (Turner at claim 1) with a multimodal particle size distribution (Turner at claim 2) wherein the sugar alcohols are erythritol, lactitol, maltitol, mannitol, sorbitol, xylitol, or combinations thereof (Turner at claim 9). Turner teaches the repressive sweetener composition formulated to have a mean particle size distribution ranging from about 200 microns to about 700 microns (Turner at [0082]). The range of particle size provided by Turner overlaps with the instantly claimed ranges. See MPEP §2144.05(I) stating that where claimed ranges overlap with prior art ranges, a prima facie case of obviousness exists. Turner teaches the sugar alcohols are present in a combined amount of from about 20 wt. % to about 80 wt. %, alternatively from about 30 wt. % to about 70 wt. %, or alternatively from about 38 wt. % to about 60 wt. % based on the total weight of the composition (Turner at [0018]). The range of sugar alcohol particles provided by Turner overlaps with the instantly claimed ranges. See MPEP §2144.05(I) stating that where claimed ranges overlap with prior art ranges, a prima facie case of obviousness exists.
Regarding instant claim 15, Turner teaches a composition with at least two sugar alcohol particles (Turner at claim 1) with a multimodal particle size distribution (Turner at claim 2) wherein the sugar alcohols are erythritol, lactitol, maltitol, mannitol, sorbitol, xylitol, or combinations thereof (Turner at claim 9).
Regarding instant claim 16, Turner teaches a composition with at least two sugar alcohol particles (Turner at claim 1) with a multimodal particle size distribution (Turner at claim 2) wherein the sugar alcohols are erythritol, lactitol, maltitol, mannitol, sorbitol, xylitol, or combinations thereof (Turner at claim 9).
Regarding instant claim 17, Turner teaches a composition with at least two sugar alcohol particles (Turner at claim 1) with a multimodal particle size distribution (Turner at claim 2) wherein the sugar alcohols are erythritol, lactitol, maltitol, mannitol, sorbitol, xylitol, or combinations thereof (Turner at claim 9).
Regarding instant claim 18, Turner teaches a composition with at least two sugar alcohol particles (Turner at claim 1) with a multimodal particle size distribution (Turner at claim 2) wherein the sugar alcohols are erythritol, lactitol, maltitol, mannitol, sorbitol, xylitol, or combinations thereof (Turner at claim 9).
Regarding instant claim 19, Turner teaches a composition with at least two sugar alcohol particles (Turner at claim 1) with a multimodal particle size distribution (Turner at claim 2) wherein the sugar alcohols are erythritol, lactitol, maltitol, mannitol, sorbitol, xylitol, or combinations thereof (Turner at claim 9).
Regarding instant claim 20, Turner teaches a composition with at least two sugar alcohol particles (Turner at claim 1) with a multimodal particle size distribution (Turner at claim 2) wherein the sugar alcohols are erythritol, lactitol, maltitol, mannitol, sorbitol, xylitol, or combinations thereof (Turner at claim 9). Turner teaches the repressive sweetener composition formulated to have a mean particle size distribution ranging from about 200 microns to about 700 microns (Turner at [0082]). The range of particle size provided by Turner overlaps with the instantly claimed ranges. See MPEP §2144.05(I) stating that where claimed ranges overlap with prior art ranges, a prima facie case of obviousness exists.
Regarding instant claim 21, Turner teaches a composition with at least two sugar alcohol particles (Turner at claim 1) with a multimodal particle size distribution (Turner at claim 2) wherein the sugar alcohols are erythritol, lactitol, maltitol, mannitol, sorbitol, xylitol, or combinations thereof (Turner at claim 9). Turner teaches the sugar alcohols are present in a combined amount of from about 20 wt. % to about 80 wt. %, alternatively from about 30 wt. % to about 70 wt. %, or alternatively from about 38 wt. % to about 60 wt. % based on the total weight of the composition (Turner at [0018]). The range of sugar alcohol particles provided by Turner overlaps with the instantly claimed ranges. See MPEP §2144.05(I) stating that where claimed ranges overlap with prior art ranges, a prima facie case of obviousness exists.
Regarding instant claim 22, Turner teaches a composition with at least two sugar alcohol particles (Turner at claim 1) with a multimodal particle size distribution (Turner at claim 2) wherein the sugar alcohols are erythritol, lactitol, maltitol, mannitol, sorbitol, xylitol, or combinations thereof (Turner at claim 9). Turner teaches the sugar alcohols are present in a combined amount of from about 20 wt. % to about 80 wt. %, alternatively from about 30 wt. % to about 70 wt. %, or alternatively from about 38 wt. % to about 60 wt. % based on the total weight of the composition (Turner at [0018]). The range of sugar alcohol particles provided by Turner overlaps with the instantly claimed ranges. See MPEP §2144.05(I) stating that where claimed ranges overlap with prior art ranges, a prima facie case of obviousness exists.
Regarding instant claim 24, Turner teaches that the composition may be a component of a treatment for the prevention or reduction of dental caries. Caries is a multi-factorial disease that involves prolonged colonization of acid-producing bacteria on teeth. Fermentation of dietary carbohydrates by caries leads to a localized drop in pH below a critical value of 5.5, resulting in the demineralization of enamel and potentially damaging underlying tooth structure. If left untreated, caries can lead to the progressive destruction of tooth structure, pain, tooth loss, loss of oral function, as well as have systemic health consequences. In an embodiment, an NSC of the type disclosed herein is a component of a regimen designed to reduce the incidence of dental caries in a subject (Turner at [0073]).
Regarding instant claim 28, Turner teaches a composition with at least two sugar alcohol particles (Turner at claim 1) with a multimodal particle size distribution (Turner at claim 2) wherein the sugar alcohols are erythritol, lactitol, maltitol, mannitol, sorbitol, xylitol, or combinations thereof (Turner at claim 9). Turner further teaches that the composition may be used mouthwashes (Turner at [0066]). Turner et al. teaches that a free-flowing composition has a Hausner ratio of less than 1.5 (Turner at [0034]). The range of Hausner ratios provided by Turner overlaps with the instantly claimed ranges of Hausner ratios. See MPEP §2144.05(I) stating that where claimed ranges overlap with prior art ranges, a prima facie case of obviousness exists. Turner teaches the repressive sweetener composition formulated to have a mean particle size distribution ranging from about 200 microns to about 700 microns (Turner at [0082]). The range of particle size provided by Turner overlaps with the instantly claimed ranges. See MPEP §2144.05(I) stating that where claimed ranges overlap with prior art ranges, a prima facie case of obviousness exists.
Regarding instant claim 29, Turner teaches a composition with at least two sugar alcohol particles (Turner at claim 1) with a multimodal particle size distribution (Turner at claim 2) wherein the sugar alcohols are erythritol, lactitol, maltitol, mannitol, sorbitol, xylitol, or combinations thereof (Turner at claim 9). Turner further teaches that the composition may be used mouthwashes (Turner at [0066]). Turner et al. teaches that a free-flowing composition has a Hausner ratio of less than 1.5 (Turner at [0034]). The range of Hausner ratios provided by Turner overlaps with the instantly claimed ranges of Hausner ratios. See MPEP §2144.05(I) stating that where claimed ranges overlap with prior art ranges, a prima facie case of obviousness exists.
Regarding instant claim 30, Turner teaches the repressive sweetener composition formulated to have a mean particle size distribution ranging from about 200 microns to about 700 microns (Turner at [0082]). The range of particle size provided by Turner overlaps with the instantly claimed ranges. See MPEP §2144.05(I) stating that where claimed ranges overlap with prior art ranges, a prima facie case of obviousness exists. Turner teaches the sugar alcohols are present in a combined amount of from about 20 wt. % to about 80 wt. %, alternatively from about 30 wt. % to about 70 wt. %, or alternatively from about 38 wt. % to about 60 wt. % based on the total weight of the composition (Turner at [0018]). The range of sugar alcohol particles provided by Turner overlaps with the instantly claimed ranges. See MPEP §2144.05(I) stating that where claimed ranges overlap with prior art ranges, a prima facie case of obviousness exists.
II) Claims 23 and 25-27 are rejected under 35 U.S.C. 103 as being unpatentable over Turner et al (US Patent Publication 2016/0263170 A1) as applied to claims 1-22, 24, and 28-30 above, and further in view of Geonnotti et al (US Patent Application Publication 2018/0140521A1).
The teachings of Turner are discussed above.
The teachings of Turner differ from the instant application insofar as they do not teach the use of zinc citrate or probiotics for oral care benefit. The teachings of Geonnotti cure this deficit.
Geonnotti teaches methods of providing at least one oral care benefit by introducing a tablet into the oral cavity to generate a fluid and forcing at least a portion of fluid generated around the oral cavity, for example, by swishing, rinsing, washing, etc., to provide an oral care benefit (Geonnotti at [0008]). Geonnotti teaches wherein the composition comprises from about 40% to about 99% by weight of the tablet of one or more sugar alcohols selected from the group consisting of sorbitol, lactitol, xylitol, erythritol, mannitol, maltitol, isomalt, and combinations of two or more thereof (Geonnotti at claim 7). Geonnotti further teaches the use of eucalyptol and menthol as cooling agents (Geonnotti at [0023]). Geonnotti further teaches that the mouthfeel provided in certain embodiments is preferably described as relatively smooth, that is, with a reduced sandy or gritty feeling, or a quick transition out of any sandy or gritting feeling while chewing or dissolving the tablet in the mouth. With respect to the watering effect, it is preferred to have a watering or salivation effect to facilitate mouthfeel benefits and/or generation of fluid (Geonnotti at [0010]). Geonnotti further teaches that the composition may comprise sugar alcohols including sorbitol, lactitol, xylitol, erythritol, mannitol, maltitol, isomalt, and polyols; and combinations of two or more thereof (Geonnotti at [0016]). Geonnotti further teaches the sugar alcohol particles may be direct compressible (DC) or non-directly compressible (non-DC) or combinations thereof (Geonnotti at [0017]). Geonnotti further teaches the composition may comprise a total amount of all sugar alcohol particles in amount of at least 40% by weight of the tablet, including from about 40 to about 99%, from about 60 to 99%, from about 75 to about 95%, from about 80 to about 90% by weight of the tablets. In certain embodiments, the tablets comprise at least 20% of each of two or more carbohydrates, including at least 20% of xylitol and at least 20% of one or more other sugar alcohols. In certain embodiments, the tablet comprises from about 20-50% of xylitol, including mixtures comprising from about 20-50% xylitol and from about 20-50% of erythritol (DC or non-DC), including from about 20-50% of xylitol, from about 20-40% of non-DC erythritol, and from about 20-40% of isomalt. In certain embodiments, the tablets comprise from about 20-50% xylitol and at least 20% of one other sugar alcohol selected from the group consisting of sorbitol, lactitol, mannitol, maltitol, isomalt, and combinations two or more thereof (Geonnotti at [0019]). Geonnotti teaches ingredients which are metabolized by oral bacteria to cause a benefit effect in the oral cavity may also be included in these tablets, including arginine, arginine monohydrochloride, and inulin-type fructans, maltodextrin, fructooligosaccharides and galactooligosaccharides. Additionally, these tablets may be used to deliver probiotic strains of bacteria, including certain species of lactobacilli and bifidobacteria, Saccharomyces spp, streptococci, enterococci and commensal Escherichia coli (Geonnotti at [0028]). Geonnotti teaches the use of zinc citrate trihydrate as a tooth strengthener (Geonnotti at [0026]). Geonnotti recites the use of at least one essential oil selected from the group consisting of menthol, thymol, eucalyptol, methyl salicylate and combinations of two or more thereof (Geonnotti at claim 13). Geonnotti teaches the use of crystalline cellulose and starches (Geonnotti at [0026]). Geonnotti teaches the use of fillers include, but are not limited to, water insoluble plastically deforming materials (e.g., microcrystalline cellulose or other cellulosic derivatives), and mixtures thereof (Geonnotti at [0034]).
The teachings of Geonnotti differ from the instant application insofar as they do not teach the use of a powder form that is not turned into a tablet. The teachings of Turner cure this deficit.
One would have been motivated to add the zinc citrate to a mouthwash composition like Turners for the benefit of strengthening teeth as taught by Geonnotti. See MPEP 2144(II).
One would have been motivated to add the oral probiotic to a mouthwash composition like Turners for the benefit of improving oral cavity health and microbiome as taught by Geonnotti. See MPEP 2144(II).
Regarding instant claim 23, Geonnotti teaches the use of zinc citrate trihydrate as a tooth strengthener (Geonnotti at [0026]).
Regarding instant claim 25, Geonnotti teaches ingredients which are metabolized by oral bacteria to cause a benefit effect in the oral cavity may also be included in these tablets, including arginine, arginine monohydrochloride, and inulin-type fructans, maltodextrin, fructooligosaccharides and galactooligosaccharides. Additionally, these tablets may be used to deliver probiotic strains of bacteria, including certain species of lactobacilli and bifidobacteria, Saccharomyces spp, streptococci, enterococci and commensal Escherichia coli (Geonnotti at [0028]).
Regarding instant claim 26, Geonnotti recites the use of at least one essential oil selected from the group consisting of menthol, thymol, eucalyptol, methyl salicylate and combinations of two or more thereof (Geonnotti at claim 13).
Regarding instant claim 27, Geonnotti teaches the use of crystalline cellulose and starches (Geonnotti at [0026]). Geonnotti teaches the use of fillers include, but are not limited to, water insoluble plastically deforming materials (e.g., microcrystalline cellulose or other cellulosic derivatives), and mixtures thereof (Geonnotti at [0034]).
Relevant Prior Art
Bartlett (WO 94/12150)
PNG
media_image1.png
625
629
media_image1.png
Greyscale
Bartlett teaches a sachet of mouthwash powders and tablets (Bartlett at Examples 22-24). Bartlett teaches a method of reducing or preventing the formation of dental plaque by applying an effective amount of the composition to a patient in need thereof (Bartlett at page 10 lines 32-38). Bartlett teaches that the composition teaches the use of menthol and cetyl pyridium chloride (Bartlett at Examples 22-24). Bartlett teaches the use of calcium carbonate (Bartlett at page 7 lines 33-36). Bartlett teaches the use of sorbitol (Bartlett at page 7 lines 27-32 and Examples 22-24) and xylitol (Examples 22-24). Bartlett teaches the use of whitening agents (Bartlett at page 10 lines 15-23).
Bondu (U.S. Patent Application Publication 2012/0276199A1)
Bondu teaches that the composition comprises a mixture of two grades of mannitol one of which is a directly compressible grade and the other is a non-directly compressible grade, in a weight ratio of from about 1:10 to about 10:1 (Bondu at claim 27). Bondu teaches a singular embodiment 2A whose composition is disclosed in the Table [0142] and wherein the manufacturing procedure for 2A discloses that the components are a solid powder at step 11. Embodiment 2A comprises an active, 36% by weight of a directly compressible mannitol with a particle size of 170 microns, 2% crystalline mannitol with a particle size 25 microns, and 27% granulated sugar alcohol particle (intragranular mannitol mixture) – this appears to be directly compressible sugar alcohol. Bondu teaches the use of colloidal silicon dioxide (Bondu at claim 24). Bondu teaches that the different pharmaceutical dosage forms that comprise the pharmaceutical compositions of the present application include solid oral dosage forms such as, but not limited to, powders, granules, pellets, tablets, and capsules [0048]. For the purpose of this rejection based on the arguments and affidavit filed 03/08/2024 the crystalline mannitol present in Embodiment 2A is considered directly compressible.
Cullup et al. (US Patent Application Publication 2009/0172902 A1)
Cullup teaches a dried powder mouthwash which is activated by the user’s saliva (Cullup at abstract).
Daniels (U.S. Patent Application Publication 2017/0071988 A1)
Daniels teaches that the composition may be a solid formulation, such as tablet, dragée, capsule, granule, powder and chewing gum, sticks, liquid formulations, such as solution, suspension, emulsion, syrup, spray, foam and semi-solid formulations, such as ointment, gel, paste (Daniels at [0117]). Daniels further discloses that the composition may be a toothpaste, tooth gel, tooth powder, tooth cleaning liquid, tooth cleaning foam, mouth wash, mouth spray, dental floss, chewing gum and lozenges (Daniels at [0118]). Daniels teaches that the composition may include lactose, glucose, sucrose, dextrose, isomalt and sugar alcohols such as lactose mannitol, sorbitol, xylitol, and erythritol (Daniels at [0067]). Daniels teaches that the composition may include zinc citrate and cetyl pyridinium chloride (Daniels at [0119]). Daniels teaches that the composition may include probiotics (Daniels at [0060]). Daniels teaches that the composition may include whitening products like hydrogen peroxide (Daniels at [0119]).
Kashid et al. (WO 2007074472 A2)
Kashid teaches a dissolving or disintegrating oral pharmaceutical comprising an active, one or more fillers larger than 150 microns (Kashid claim 1). Where the filler is mannitol (Kashid claim 6) and the filler is 30% to 80% by weight of the composition (Kashid claim 4) contains a sweetener or flavoring agent (Kashid claims 11, 24, 25) and the composition dissolves in 60 seconds or less (Kashid claim 10) and preferably 30 seconds or less (Kashid at page 2 paragraph 1). Kashid teaches that the composition can also be converted into other dosage forms like dispersible tablets, granules and sachets containing such granules (Kashid page 6 paragraph 2). Kashid teaches that the powder is a mix of fillers, actives, and excipients (Kashid at page 5, lines 30-33) and teaches that the sugar alcohols can have a variety of size distributions (Kashid at page 7, line 26 - page 8, line 7). Kashid teaches that the composition may include xylitol, mannitol, lactitol, erythritol, and maltitol (Kashid at page 7 lines 27-30).
Khankari et al. (U.S. Patent 6,024,981)
Khankari teaches a hard compressed rapidly dissolvable dosage form adapted for direct oral dosing and minimizing grit in the mouth of the patient (col.2, lines 5-41). The dosage comprises an active ingredient and a matrix including a non-directly compressible filler (Khankari at claim 1) and further describes that the filler can be a non-directly compression sugar alcohol (Khankari at claim 17) ranging from about 25% to about 95% the weight of the composition (Khankari at claim 14). Khankari further teaches that the 85% of directly compressible fillers have an average particle size of less than 100 microns (Khankari Column 9 lines 44-61). Khankari teaches the use of directly compressible sugar alcohols (Khankari column 9, lines 1-30; column 13, lines 8-14) like mannitol (Khankari column 9 lines 49-50) and non-directly compressible sugar alcohols such as mannitol and sorbitol (Khankari column 9 line 62 – column 10 line 3). Khankari teaches that the active may be pharmaceutical ingredients, vitamins, minerals and dietary supplements (Column 4 lines 35-65). Khankari also teaches the use of cellulosic materials as a coating material (Column 6 lines 3-15).
Perez et al (US Patent Application Publication 20160000695 A1)
Perez teaches a mouthwash (Perez at [0075]) which is in a free-flowing powder form before tableting for the benefit of better ingredient mixing (Perez at [0054-005]). Perez further teaches the use of zinc and specifically zinc gluconate (Perez at [0090-0092]) to treat bad breath. Perez further teaches the use of xylitol (Perez at [0053]).
Virtanen et al. (U.S. Patent 5,536,526)
Virtanen et al. teaches a free flowing compressible granulate comprising 94% to 98% xylitol (Virtanen at claim 1) which produces a cooling effect (Virtanen at column 2, lines 48-46), 1% to 5% other polyols or combinations of polyols such as sorbitol (Virtanen at claim 4), mannitol, lactitol, maltitol, or isomalt (Virtanen at claims 3 and 9). Where the average particle size is between 100 microns and 1000 microns (Virtanen at claim 7). Virtanen mentions a known ratio in the art between xylitol and sorbitol as between 1:1 and 0.43:1 (Virtanen at column 5, lines 1-15) but prefers a predominantly xylitol composition. Virtanen further teaches that xylitol may stimulate the production of saliva and reduce plaque (Virtanen at column 2, lines 29-37).
The relevant prior art is presented for completeness of the record and compact prosecution. In selecting the references to be used in rejecting the claims, the examiner should carefully compare the references with one another and with the applicant’s disclosure to avoid an unnecessary number of rejections over similar references. The examiner is not called upon to cite all references that may be available, but only the "best." (See 37 CFR 1.104(c).) Multiplying references, any one of which is as good as, but no better than, the others, adds to the burden and cost of prosecution and should therefore be avoided. See MPEP 904.03, third paragraph in section. The examiner takes the position that above prior art appears to be just as good as Turner and Geonnotti. As such, no rejection over the above prior art has been written in view of the provisions of MPEP 904.03.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
A) Claims 1-30 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-29 of U.S. Patent No. 12,128,138B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the reference method does not require at specific Hausner ratio which is required by the independent claim of the instant application. The instant application recites a powder mixture, the powder mixture having a Hausner ratio of 1.00 to 1.59 and comprising a population of particles and one or more active ingredients, the population of particles including at least two types of sugar alcohol particles selected from the group consisting of i) non-directly compressible (non-DC) sugar alcohol particles, ii) directly compressible (DC) sugar alcohol particles that are not granulated sugar alcohol particles, and iii) granulated sugar alcohol particles, wherein: at least one of said at least two types of sugar alcohol particles having a particle size with more than 50% of the particles being below 250 microns; and at least one of said at least two types of sugar alcohol particles being present in an amount of at least 20% by weight of the powder mixture(Instant application at claim 1).
The reference patent recites a method of achieving oral care benefits, comprising the steps of: a) providing a swishable powder delivery system having a content of at least two types of sugar alcohol particles with different particle size distributions and one or more active ingredients, the powder delivery system being a dry and flowable population of particles in solid form; b) administering said dry and flowable population of particles in solid form without adding water to the oral cavity of a human subject; c) swishing said dry and flowable population of particles in solid form without adding water by the human subject; and wherein fluid is generated in the oral cavity upon swishing said dry and flowable population of particles in solid form without adding water by the human subject, thereby resembling a liquid mouthwash (138 at claim 1). The reference patent recites wherein swishing said powder delivery system is characterised by forcing the powder delivery system around the oral cavity for at least 5 seconds (138 at claim 2). The reference patent recites wherein at least a portion of the fluid generated by swishing said powder delivery system is forced around the oral cavity for at least 10 seconds (138 at claim 3). The reference patent recites wherein oral care benefits are obtained by swishing said powder delivery system and/or at least a portion of the fluid generated in the oral cavity for at least 10 seconds (138 at claim 4). The reference patent recites wherein at least one of the at least two types of sugar alcohol particles with different particle size distributions is substantially free flowing (‘138 at claim 5). The reference patent recites wherein the Hausner ratio of the powder delivery system is between 1.00 and 1.59(138 at claim 6). The reference patent recites wherein the powder delivery system provides an improved cooling effect compared to a powder delivery system without at least one of the at least two types of sugar alcohol particles with different particle size distributions (‘138 at claim 7). The reference patent recites wherein the powder delivery system provides an improved watering effect compared to a powder delivery system without at least one of the at least two types of sugar alcohol particles with different particle size distributions (‘138 at claim 8). The reference patent recites wherein the powder delivery system provides an improved mouthfeel compared to a powder delivery system without at least one of the at least two types of sugar alcohol particles with different particle size distributions, the improved mouthfeel including at least one of less sandy mouthfeel, less dusty mouthfeel, less roughness mouthfeel, less sticky or improved texture (‘138 at claim 9). The reference patent recites wherein the population of particles includes at least 20% of one type of sugar alcohol particles having a particle size with more than 80% of the particles being below 250 microns and at least 20% of another type of sugar alcohol particles having a particle size with more than 80% of the particles being below 250 microns (‘138 at claim 10). The reference patent recites wherein the population of particles includes at least 20% of one type of sugar alcohol particles having a particle size with more than 80% of the particles being below 250 microns and at least 20% of another type of sugar alcohol particles having a particle size with more than 80% of the particles being below 300 microns (‘138 at claim 11). The reference patent recites wherein the population of particles includes at least two types of sugar alcohol particles comprising i) granulated sugar alcohol particles and ii) non-directly compressible (non-DC) sugar alcohol particles (‘138 at claim 12). The reference patent recites wherein the population of particles includes at least two types of sugar alcohol particles comprising i) granulated sugar alcohol particles and iii) directly compressible (DC) sugar alcohol particles that are not granulated sugar alcohol particles (‘138 at claim 13). The reference patent recites wherein the population of particles includes at least two types of sugar alcohol particles comprising ii) non-directly compressible (non-DC) sugar alcohol particles and iii) directly compressible (DC) sugar alcohol particles that are not granulated sugar alcohol particles (‘138 at claim 14). The reference patent recites wherein the population of particles includes at least two types of sugar alcohol particles comprising ii) non-directly compressible (non-DC) sugar alcohol particles in an amount of at least 20% by weight of the population of particles and iii) directly compressible (DC) sugar alcohol particles that are not granulated sugar alcohol particles in an amount of at least 20% by weight of the population of particles (‘138 at claim 15). The reference patent recites wherein the population of particles includes at least two types of sugar alcohol particles comprising ii) non-directly compressible (non-DC) sugar alcohol particles having a particle size with more than 80% of the particles being below 500 microns and iii) directly compressible (DC) sugar alcohol particles that are not granulated sugar alcohol particles having a particle size with more than 80% of the particles being below 500 microns (‘138 at claim 16). The reference patent recites wherein the population of particles includes at least two types of sugar alcohol particles comprising ii) non-directly compressible (non-DC) sugar alcohol particles having a particle size with more than 50% of the particles being below 250 microns and iii) directly compressible (DC) sugar alcohol particles that are not granulated sugar alcohol particles having a particle size with more than 80% of the particles being below 300 microns (‘138 at claim 17). The reference patent recites wherein the population of particles includes at least three types of sugar alcohol particles comprising i) granulated sugar alcohol particles, ii) non-directly compressible (non-DC) sugar alcohol particles and ili) directly compressible (DC) sugar alcohol particles that are not granulated sugar alcohol particles (‘138 at claim 18). The reference patent recites wherein the population of particles includes at least two types of sugar alcohol particles comprising i) granulated sugar alcohol particles selected from granulated particles of xylitol, maltitol, isomalt, mannitol, erythritol, lactitol or combinations thereof (‘138 at claim 19). The reference patent recites wherein the population of particles includes at least two types of sugar alcohol particles comprising ii) non-directly compressible (non-DC) sugar alcohol particles selected from non-DC particles of xylitol, maltitol, isomalt, mannitol, erythritol, lactitol or combinations thereof (‘138 at claim 20). The reference patent recites wherein the population of particles includes at least two types of sugar alcohol particles comprising iii) directly compressible (DC) sugar alcohol particles that are not granulated sugar alcohol particles, and wherein the directly compressible (DC) sugar alcohol particles that are not granulated sugar alcohol particles iii) comprise sorbitol (138 at claim 21). The reference patent recites wherein the population of particles includes at least two types of sugar alcohol particles comprising i) granulated sugar alcohol particles and ii) non-directly compressible (non-DC) sugar alcohol particles in a weight ratio between i) and ii) of between 0.2 and 5 (‘138 at claim 22). The reference patent recites wherein the population of particles includes at least two types of sugar alcohol particles comprising i) granulated sugar alcohol particles and iii) directly compressible (DC) sugar alcohol particles that are not granulated sugar alcohol particles in a weight ratio between i) and iii) of between 0.2 and 5 (‘138 at claim 23). The reference patent recites wherein the population of particles includes at least two types of sugar alcohol particles comprising ii) non-directly compressible (non-DC) sugar alcohol particles and iii) directly compressible (DC) sugar alcohol particles that are not granulated sugar alcohol particles in a weight ratio between ii) and iii) of between 0.2 and 5 (‘138 at claim 24). The reference patent recites wherein the active ingredient comprises oral care agents including zinc acetate and/or zinc gluconate (‘138 at claim 25). The reference patent recites wherein the active ingredient comprises oral care agents for oral care benefits including bad breath, plaque, gingivitis, whitening, or combinations of two or more thereof (‘138 at claim 26). The reference patent recites wherein the active ingredient comprises anti-septics including cetyl pyridinium chloride (CPC) and/or essential oils selected from the group consisting of cineole, menthol, methyl salicylate, thymol, and any combination thereof (‘138 at claim 27). The reference patent recites wherein the swishable powder further comprises abrasive agents, including calcium carbonate and/or talc (‘138 at claim 28). The reference patent recites wherein the swishable powder further comprises flow promoting agents, including silicon dioxide and/or rice hulles and/or cellulosic fibers (‘138 at claim 29).
Reference claims effectively anticipate the instant claims resulting in a prima facie case of anticipatory type non-statutory double patenting.
B) Claims 1-30 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of U.S. Patent No. 12,257,346 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the reference patent requires a salivation effect and a cooling effect from the sugar alcohol particles that is not required in the independent claim of the instant application. The instant application recites a powder mixture, the powder mixture having a Hausner ratio of 1.00 to 1.59 and comprising a population of particles and one or more active ingredients, the population of particles including at least two types of sugar alcohol particles selected from the group consisting of i) non-directly compressible (non-DC) sugar alcohol particles, ii) directly compressible (DC) sugar alcohol particles that are not granulated sugar alcohol particles, and iii) granulated sugar alcohol particles, wherein: at least one of said at least two types of sugar alcohol particles having a particle size with more than 50% of the particles being below 250 microns; and at least one of said at least two types of sugar alcohol particles being present in an amount of at least 20% by weight of the powder mixture(Instant application at claim 1).
The reference patent recites a powder mixture for oral care benefits, the powder mixture having a Hausner ratio of 1.00 to 1.59 and comprising a population of particles and one or more active ingredients, the population of particles being administered as dry and flowable powder and including at least two types of sugar alcohol particles selected from the group consisting of i) non-directly compressible (non-DC) sugar alcohol particles that provide the population of particles with a salivation effect upon oral administration of the population of particles, ii) directly compressible (DC) sugar alcohol particles that are not granulated sugar alcohol particles and provide the population of particles with a cooling effect upon oral administration of the population of particles, and iii) granulated sugar alcohol particles, wherein: at least one of said at least two types of sugar alcohol particles having a particle size with more than 50% of the particles being below 250 microns; and at least one of said at least two types of sugar alcohol particles being present in an amount of at least 20% by weight of the powder mixture (‘346 at claim 1). The reference patent recites wherein at least one of i) or ii) having a particle size with more than 50% of the particles being below 250 microns; and at least one of said at least two types of sugar alcohol particles being present in an amount of at least 20% by weight of the powder mixture (‘346 at claim 2). The reference patent recites wherein at least one of said at least two types of sugar alcohol particles having a particle size with more than 50% of the particles being below 250 microns; and at least one of said at least two types of sugar alcohol particles having a particle size with more than 50% of the particles being below 250 microns being present in an amount of at least 20% by weight of the powder mixture (‘346 at claim 3). The reference patent recites wherein at least one of i) or ii) having a particle size with more than 50% of the particles being below 250 microns; and at least one of said at least two types of sugar alcohol particles having a particle size with more than 50% of the particles being below 250 microns being present in an amount of at least 20% by weight of the powder mixture (‘346 at claim 4). The reference patent recites wherein at least one of said at least two types of sugar alcohol particles comprises i) non-directly compressible (non-DC) sugar alcohol particles; at least one of said at least two types of sugar alcohol particles having a particle size with more than 50% of the particles being below 250 microns; and at least one of said at least two types of sugar alcohol particles being present in an amount of at least 20% by weight of the powder mixture (‘346 at claim 5). The reference patent recites wherein at least one of said at least two types of sugar alcohol particles comprises i) non-directly compressible (non-DC) sugar alcohol particles; at least i) having a particle size with more than 50% of the particles being below 250 microns; and at least one of said at least two types of sugar alcohol particles being present in an amount of at least 20% by weight of the powder mixture (‘346 at claim 6). The reference patent recites wherein at least one of said at least two types of sugar alcohol particles comprises i) non-directly compressible (non-DC) sugar alcohol particles; at least one of said at least two types of sugar alcohol particles having a particle size with more than 50% of the particles being below 250 microns; and at least one of said at least two types of sugar alcohol particles having a particle size with more than 50% of the particles being below 250 microns being present in an amount of at least 20% by weight of the powder mixture (‘346 at claim 7). The reference patent recites wherein at least one of said at least two types of sugar alcohol particles comprises i) non-directly compressible (non-DC) sugar alcohol particles; at least i) having a particle size with more than 50% of the particles being below 250 microns; and at least one of said at least two types of sugar alcohol particles having a particle size with more than 50% of the particles being below 250 microns being present in an amount of at least 20% by weight of the powder mixture (‘346 at claim 8). The reference patent recites wherein at least one of said at least two types of sugar alcohol particles comprises ii) directly compressible (DC) sugar alcohol particles that are not granulated sugar alcohol particles; at least one of said at least two types of sugar alcohol particles having a particle size with more than 50% of the particles being below 250 microns; and at least one of said at least two types of sugar alcohol particles being present in an amount of at least 20% by weight of the powder mixture (‘346 at claim 9). The reference patent recites wherein at least one of said at least two types of sugar alcohol particles comprises ii) directly compressible (DC) sugar alcohol particles that are not granulated sugar alcohol particles; at least ii) having a particle size with more than 50% of the particles being below 250 microns; and at least one of said at least two types of sugar alcohol particles being present in an amount of at least 20% by weight of the powder mixture (‘346 at claim 10). The reference patent recites wherein at least one of said at least two types of sugar alcohol particles comprises ii) directly compressible (DC) sugar alcohol particles that are not granulated sugar alcohol particles; at least one of said at least two types of sugar alcohol particles having a particle size with more than 50% of the particles being below 250 microns; and at least one of said at least two types of sugar alcohol particles having a particle size with more than 50% of the particles being below 250 microns being present in an amount of at least 20% by weight of the powder mixture (‘346 at claim 11). The reference patent recites wherein at least one of said at least two types of sugar alcohol particles comprises ii) directly compressible (DC) sugar alcohol particles that are not granulated sugar alcohol particles; at least ii) having a particle size with more than 50% of the particles being below 250 microns; and at least one of said at least two types of sugar alcohol particles having a particle size with more than 50% of the particles being below 250 microns being present in an amount of at least 20% by weight of the powder mixture (‘346 at claim 12). The reference patent recites wherein at least 50% by weight of said at least two types of sugar alcohol particles have a particle size below 250 microns (‘346 at claim 13). The reference patent recites wherein the population of particles includes at least 20% of one type of sugar alcohol particles having a particle size with more than 80% of the particles being below 250 microns and at least 20% of another type of sugar alcohol particles having a particle size with more than 80% of the particles being below 300 microns (‘346 at claim 14). The reference patent recites wherein the powder mixture provides an improved mouthfeel compared to a powder mixture without the at least one of the at least two types of sugar alcohol particles, the improved mouthfeel including at least one of less sandy mouthfeel, less dusty mouthfeel, less roughness mouthfeel, less sticky or improved texture (‘346 at claim 15). The reference patent recites wherein the population of particles includes i) non-directly compressible (non-DC) sugar alcohol particles and iii) granulated sugar alcohol particles (‘346 at claim 16). The reference patent recites wherein the population of particles includes ii) directly compressible (DC) sugar alcohol particles that are not granulated sugar alcohol particles and iii) granulated sugar alcohol particles (‘346 at claim 17). The reference patent recites wherein the population of particles includes i) non-directly compressible (non-DC) sugar alcohol particles and ii) directly compressible (DC) sugar alcohol particles that are not granulated sugar alcohol particles (‘346 at claim 18). The reference patent recites wherein the population of particles includes at least three types of sugar alcohol particles comprising i) non-directly compressible (non-DC) sugar alcohol particles, ii) directly compressible (DC) sugar alcohol particles that are not granulated sugar alcohol particles and iii) granulated sugar alcohol particles (‘346 at claim 19). The reference patent recites wherein the population of particles includes i) non-directly compressible (non-DC) sugar alcohol particles selected from the group consisting of non-DC particles of xylitol, maltitol, isomalt, mannitol, erythritol, lactitol, and combinations thereof (‘346 at claim 20). The reference patent recites wherein the population of particles includes i) non-directly compressible (non-DC) sugar alcohol particles, and wherein the non-directly compressible (non-DC) sugar alcohol particles provide the population of particles with a salivation effect upon oral administration of the population of particles (‘346 at claim 21). The reference patent recites wherein the population of particles includes ii) directly compressible (DC) sugar alcohol particles that are not granulated sugar alcohol particles, and wherein the directly compressible (DC) sugar alcohol particles that are not granulated sugar alcohol particles provide the population of particles with a cooling effect upon oral administration of the population of particles (‘346 at claim 22). The reference patent recites wherein the population of particles includes i) non-directly compressible (non-DC) sugar alcohol particles and ii) directly compressible (DC) sugar alcohol particles that are not granulated sugar alcohol particles in a weight ratio between i) and ii) of between 0.2 and 5 (‘346 at claim 23). The reference patent recites wherein the one or more active ingredients comprises zinc acetate and/or zinc gluconate and/or zinc citrate (‘346 at claim 24). The reference patent recites wherein the one or more active ingredients comprises one or more oral care agents selected from the group consisting of oral care agents for whitening teeth, oral care agents for the alleviation or treatment of bad breath, oral care agents for the alleviation or treatment of plaque, oral care agents for the alleviation or treatment of gingivitis, and combinations of two or more thereof (‘346 at claim 25). The reference patent recites wherein the one or more active ingredients comprises oral care agents for oral care benefits including one or more probiotic agents (‘346 at claim 26). The reference patent recites wherein the one or more active ingredients comprises anti-septics including cetyl pyridinium chloride (CPC) and/or essential oils selected from the group consisting of cineole, menthol, methyl salicylate, thymol, and any combination thereof (‘346 at claim 27). The reference patent recites further comprising flow promoting agents including one or more of silicon dioxide, rice hulls, and cellulosic species (‘346 at claim 28). The reference patent recites a mouthwash comprising a powder mixture, the powder mixture having a Hausner ratio of 1.00 to 1.59 and comprising a population of particles and one or more active ingredients, the population of particles being administered as dry and flowable powder and including at least two types of sugar alcohol particles selected from the group consisting of i) non-directly compressible (non-DC) sugar alcohol particles that provide the population of particles with a salivation effect upon oral administration of the population of particles, ii) directly compressible (DC) sugar alcohol particles that are not granulated sugar alcohol particles and provide the population of particles with a cooling effect upon oral administration of the population of particles, and iii) granulated sugar alcohol particles, wherein: at least one of said at least two types of sugar alcohol particles having a particle size with more than 50% of the particles being below 250 microns; and at least one of said at least two types of sugar alcohol particles being present in an amount of at least 20% by weight of the powder mixture (‘346 at claim 29). The reference patent recites a toothpaste comprising a powder mixture, the powder mixture having a Hausner ratio of 1.00 to 1.59 and comprising a population of particles and one or more active ingredients, the population of particles being administered as dry and flowable powder and including at least two types of sugar alcohol particles selected from the group consisting of i) non-directly compressible (non-DC) sugar alcohol particles that provide the population of particles with a salivation effect upon oral administration of the population of particles, ii) directly compressible (DC) sugar alcohol particles that are not granulated sugar alcohol particles and provide the population of particles with a cooling effect upon oral administration of the population of particles, and iii) granulated sugar alcohol particles, wherein: at least one of said at least two types of sugar alcohol particles having a particle size with more than 50% of the particles being below 250 microns; and at least one of said at least two types of sugar alcohol particles being present in an amount of at least 20% by weight of the powder mixture (‘346 at claim 30).
Reference claims effectively anticipate the instant claims resulting in a prima facie case of anticipatory type non-statutory double patenting.
C) Claims 1-30 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-28 of U.S. Patent No. 12,551,439 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the reference patent requires a flowpack which is not required by the instant application. The instant application recites a powder mixture, the powder mixture having a Hausner ratio of 1.00 to 1.59 and comprising a population of particles and one or more active ingredients, the population of particles including at least two types of sugar alcohol particles selected from the group consisting of i) non-directly compressible (non-DC) sugar alcohol particles, ii) directly compressible (DC) sugar alcohol particles that are not granulated sugar alcohol particles, and iii) granulated sugar alcohol particles, wherein: at least one of said at least two types of sugar alcohol particles having a particle size with more than 50% of the particles being below 250 microns; and at least one of said at least two types of sugar alcohol particles being present in an amount of at least 20% by weight of the powder mixture(Instant application at claim 1).
The reference patent recites a flowpack for oral delivery of active ingredients, the flowpack comprising an outer package material enclosing a dissolvable unstamped powder delivery system as the entire content of matter filled into the flowpack comprising: a population of particles; and one or more active ingredients, the population of particles including at least two types of sugar alcohol particles with different particle size distributions that are all flowable, wherein at least one of said at least two types of sugar alcohol particles comprises granulated sugar alcohol particles in an amount of at least 20% by weight of the dissolvable unstamped powder delivery system and at least one of said at least two types of sugar alcohol particles, apart from said granulated sugar alcohol particles, have a particle size with more than 80% of the particles being below 500 microns, and wherein a Hausner ratio of the dissolvable unstamped powder delivery system is between 1.00 and 1.45 (‘439 at claim 1). The reference patent recites wherein at least one of said at least two types of sugar alcohol particles, apart from said granulated sugar alcohol particles, comprises: non-directly compressible (non-DC) sugar alcohol particles (‘439 at claim 2). The reference patent recites wherein at least one of said at least two types of sugar alcohol particles, apart from said granulated sugar alcohol particles, comprises: directly compressible (DC) sugar alcohol particles that are not granulated sugar alcohol particles (‘439 at claim 3). The reference patent recites wherein the population of particles includes at least two types of sugar alcohol particles, apart from said granulated sugar alcohol particles, comprising: non-directly compressible (non-DC) sugar alcohol particles; and directly compressible (DC) sugar alcohol particles that are not granulated sugar alcohol particles (‘439 at claim 4). The reference patent recites wherein at least one of said at least two types of sugar alcohol particles, apart from said granulated sugar alcohol particles, comprises: non-directly compressible (non-DC) sugar alcohol particles having a particle size with more than 80% of the particles being below 500 microns (‘439 at claim 5). The reference patent recites wherein at least one of said at least two types of sugar alcohol particles, apart from said granulated sugar alcohol particles, comprises: non-directly compressible (non-DC) sugar alcohol particles having a particle size with more than 80% of the particles being below 250 microns (‘439 at claim 6). The reference patent recites wherein at least one of said at least two types of sugar alcohol particles, apart from said granulated sugar alcohol particles, comprises: directly compressible (DC) sugar alcohol particles that are not granulated sugar alcohol particles having a particle size with more than 80% of the particles being below 500 microns (‘439 at claim 7). The reference patent recites wherein at least one of said at least two types of sugar alcohol particles, apart from said granulated sugar alcohol particles, comprises: directly compressible (DC) sugar alcohol particles that are not granulated sugar alcohol particles having a particle size with more than 80% of the particles being below 300 microns (‘439 at claim 8). The reference patent recites wherein the population of particles includes at least two types of sugar alcohol particles, apart from said granulated sugar alcohol particles, comprising: non-directly compressible (non-DC) sugar alcohol particles having a particle size with more than 80% of the particles being below 250 microns; and directly compressible (DC) sugar alcohol particles that are not granulated sugar alcohol particles having a particle size with more than 80% of the particles being below 300 microns (‘439 at claim 9). The reference patent recites wherein the granulated sugar alcohol particles are in an amount of at least 25% by weight of the dissolvable unstamped powder delivery system (‘439 at claim 10). The reference patent recites wherein at least one of said at least two types of sugar alcohol particles, apart from said granulated sugar alcohol particles, comprises: non-directly compressible (non-DC) sugar alcohol particles in an amount of at least 20% by weight of the dissolvable unstamped powder delivery system (‘439 at claim 11). The reference patent recites wherein at least one of said at least two types of sugar alcohol particles, apart from said granulated sugar alcohol particles, comprises: directly compressible (DC) sugar alcohol particles that are not granulated sugar alcohol particles in an amount of at least 20% by weight of the dissolvable unstamped powder delivery system (‘439 at claim 12). The reference patent recites wherein the population of particles includes at least two types of sugar alcohol particles, apart from said granulated sugar alcohol particles, comprising: non-directly compressible (non-DC) sugar alcohol particles in an amount of at least 20% by weight of the dissolvable unstamped powder delivery system; and directly compressible (DC) sugar alcohol particles that are not granulated sugar alcohol particles in an amount of at least 20% by weight of the dissolvable unstamped powder delivery system (‘439 at claim 13). The reference patent recites wherein the granulated sugar alcohol particles are selected from granulated particles of xylitol, maltitol, isomalt, mannitol, erythritol, lactitol, dextrose or combinations thereof (‘439 at claim 14). The reference patent recites wherein at least one of said at least two types of sugar alcohol particles comprises: non-directly compressible (non-DC) sugar alcohol particles, and wherein the non-DC sugar alcohol particles are selected from non-DC particles of xylitol, maltitol, isomalt, mannitol, erythritol, lactitol or combinations thereof (‘439 at claim 15). The reference patent recites wherein at least one of said at least two types of sugar alcohol particles, apart from said granulated sugar alcohol particles, comprises: directly compressible (DC) sugar alcohol particles that are not granulated sugar alcohol particles, and wherein the DC sugar alcohol particles that are not granulated sugar alcohol particles comprise sorbitol and/or dextrose (‘439 at claim 16). The reference patent recites wherein at least one of said at least two types of sugar alcohol particles, apart from said granulated sugar alcohol particles, comprises: non-directly compressible (non-DC) sugar alcohol particles, wherein a weight ratio between said granulated sugar alcohol particles and said non-DC sugar alcohol particles is between 0.2 and 5 (‘439 at claim 17). The reference patent recites wherein the one or more active ingredients is selected from the group consisting of diphenhydramine, acetaminophen, ibuprofen, phenylephrine, dextromethorphan, guaifenesin, and any combinations thereof (‘439 at claim 18). The reference patent recites wherein the one or more active ingredients comprises one or more of zinc acetate, zinc gluconate and zinc citrate (‘439 at claim 19). The reference patent recites wherein the one or more active ingredients comprises oral care agents for oral care benefits selected from the group consisting of bad breath, plaque, gingivitis, whitening, and combinations thereof (‘439 at claim 20). The reference patent recites wherein the one or more active ingredients comprises oral care agents for oral care benefits selected from one or more probiotic agents (‘439 at claim 21). The reference patent recites wherein the one or more active ingredients comprises anti-septics, and wherein the anti-septics comprise cetyl pyridinium chloride (CPC) and/or essential oils selected from the group consisting of cineole, menthol, methyl salicylate, thymol, and any combination thereof (‘439 at claim 22). The reference patent recites wherein the population of particles is a dose of about 0.5 to 5.0 g (‘439 at claim 23). The reference patent recites wherein the Hausner ratio of the dissolvable unstamped powder delivery system is between 1.00 and 1.34 (‘439 at claim 24). The reference patent recites wherein the Hausner ratio of the dissolvable unstamped powder delivery system is between 1.00 and 1.25 (‘439 at claim 25). The reference patent recites a flowpack for oral delivery of active ingredients, the flowpack comprising an outer package material enclosing a dissolvable unstamped powder delivery system as the entire content of matter filled into the flowpack comprising: a population of particles; and one or more active ingredients, the population of particles including at least two types of sugar alcohol particles with different particle size distributions that are all flowable, wherein at least one of said at least two types of sugar alcohol particles comprises granulated sugar alcohol particles in an amount of at least 20% by weight of the dissolvable unstamped powder delivery system and at least one of said at least two types of sugar alcohol particles, apart from said granulated sugar alcohol particles, comprises non-directly compressible (non-DC) sugar alcohol particles having a particle size with more than 80% of the particles being below 500 microns, and wherein a Hausner ratio of the dissolvable unstamped powder delivery system is between 1.00 and 1.45 (‘439 at claim 26). The reference patent recites wherein the non-directly compressible (non-DC) sugar alcohol particles have a particle size with more than 80% of the particles being below 250 microns (‘439 at claim 27). The reference patent recites flowpack for oral delivery of active ingredients, the flowpack comprising an outer package material enclosing a dissolvable unstamped powder delivery system as the entire content of matter filled into the flowpack comprising: a population of particles; and one or more active ingredients, the population of particles including at least two types of sugar alcohol particles with different particle size distributions that are all flowable, wherein at least one of said at least two types of sugar alcohol particles comprises granulated sugar alcohol particles in an amount of at least 20% by weight of the dissolvable unstamped powder delivery system and at least one of said at least two types of sugar alcohol particles, apart from said granulated sugar alcohol particles, comprises directly compressible (DC) sugar alcohol particles that are not granulated sugar alcohol particles having a particle size with more than 80% of the particles being below 500 microns, and wherein a Hausner ratio of the dissolvable unstamped powder delivery system is between 1.00 and 1.45 (‘439 at claim 28).
Reference claims effectively anticipate the instant claims resulting in a prima facie case of anticipatory type non-statutory double patenting.
D) Claims 1-30 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 12,702,643 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the reference patent requires a mucoadhesive polymer that is not required by the instant application. The instant application recites a powder mixture, the powder mixture having a Hausner ratio of 1.00 to 1.59 and comprising a population of particles and one or more active ingredients, the population of particles including at least two types of sugar alcohol particles selected from the group consisting of i) non-directly compressible (non-DC) sugar alcohol particles, ii) directly compressible (DC) sugar alcohol particles that are not granulated sugar alcohol particles, and iii) granulated sugar alcohol particles, wherein:at least one of said at least two types of sugar alcohol particles having a particle size withmore than 50% of the particles being below 250 microns; andat least one of said at least two types of sugar alcohol particles being present in an amount of at least 20% by weight of the powder mixture(Instant application at claim 1).
The reference patent recites an oral tablet for oromucosal delivery of biologically active compounds, the tablet comprising: i) a sugar alcohol composition in powder form comprising one or more sugar alcohol particles selected from the group consisting of sorbitol particles, erythritol particles, xylitol particles, lactitol particles, maltitol particles, mannitol particles, isomalt particles, and combinations thereof, in an amount of at least 60% by weight of the tablet; and ii) an ion-exchange composition in powder form, the ion-exchange composition in powder form being located in the tablet as a separate composition mixed with the sugar alcohol composition in powder form, and the ion-exchange composition in powder form comprising a plurality of particles consisting of at least one water-soluble anionic mucoadhesive polymer loaded with nicotine, wherein an average particle diameter of the plurality of particles consisting essentially of the at least one water-soluble anionic mucoadhesive polymer loaded with nicotine is from 10 to 1000 microns, wherein the at least one water-soluble anionic mucoadhesive polymer is selected from sulfonated polysaccharides, anionic polysaccharides, polyacrylic acid, and combinations thereof, wherein the plurality of particles consisting of the at least one water-soluble anionic mucoadhesive polymer loaded with nicotine are operable to form a gel in contact with the oral mucosa when hydrated with saliva, wherein the plurality of particles consisting of the at least one water-soluble anionic mucoadhesive polymer loaded with nicotine are operable to protect the nicotine until adherence to the oral mucosa, wherein the weight ratio of the at least one water-soluble anionic mucoadhesive polymer to nicotine is from 2:1 to 20:1, and wherein the oral tablet is an orally disintegrating tablet (‘643 at claim 1). The reference patent recites wherein a weight ratio of the at least one water-soluble anionic mucoadhesive polymer to nicotine is from 2:1 to 15:1 (‘643 at claim 2). The reference patent recites wherein the at least one water-soluble anionic mucoadhesive polymer is weakly acidic (‘643 at claim 3). The reference patent recites wherein the at least one water-soluble anionic mucoadhesive polymer comprises carboxylic functional groups (‘643 at claim 4). The reference patent recites wherein the at least one water-soluble anionic mucoadhesive polymer is selected from the group consisting of xanthan gum, carrageenan, carbomer, carboxymethyl cellulose and combinations thereof (‘643 at claim 5). The reference patent recites wherein the oral tablet comprises the ion-exchange composition in an amount of 0.1 to 25% by weight of the tablet (‘643 at claim 6). The reference patent recites wherein the oral tablet comprises a buffering agent in an amount of 1 to 5% by weight of the tablet (‘643 at claim 7). The reference patent recites wherein the one or more sugar alcohol particles comprises non-DC sugar alcohol particles selected from non-DC particles of erythritol, maltitol, xylitol, isomalt, and combinations thereof (‘643 at claim 8). The reference patent recites wherein the one or more sugar alcohol particles comprises at least 20% by weight of non-DC sugar alcohol particles with a particle size above 500 μm (‘643 at claim 9). The reference patent recites wherein the one or more sugar alcohol particles comprises directly compressible (DC) and non-directly compressible (non-DC) sugar alcohol particles present in the tablet in a weight ratio between said non-DC sugar alcohol particles and said DC sugar alcohol particles of 0.2 and 1.2 (‘643 at claim 10). The reference patent recites wherein the one or more sugar alcohol particles is tableted into a first module and combined with a second population of particles that is tableted into a second module, and wherein the second module is different in composition than the first module (‘643 at claim 11). The reference patent recites wherein the one or more sugar alcohol particles is tableted into a first module and combined with a second population of particles that is tableted into a second module, and wherein the second module includes gum base (‘643 at claim 12). The reference patent recites wherein the oral tablet further comprises a disintegrant in an amount of 1 to 10% by weight of the tablet (‘643 at claim 13). The reference patent recites a powder composition comprising: i) a sugar alcohol composition in powder form comprising one or more sugar alcohol particles selected from the group consisting of sorbitol particles, erythritol particles, xylitol particles, lactitol particles, maltitol particles, mannitol particles, isomalt particles, and combinations thereof, in an amount of at least 60% by weight of the powder composition; and ii) an ion-exchange composition in powder form for oromucosal delivery of biologically active compounds, the ion-exchange composition comprising: a plurality of particles consisting of at least one water-soluble anionic mucoadhesive polymer loaded with nicotine, wherein an average particle diameter of the plurality of particles consisting of the at least one water-soluble anionic mucoadhesive polymer loaded with nicotine is from 10 to 1000 microns, wherein the at least one water-soluble anionic mucoadhesive polymer is selected from the group consisting of xanthan gum, carrageenan, carbomer, carboxymethyl cellulose and combinations thereof, wherein the plurality of particles consisting of the at least one water-soluble anionic mucoadhesive polymer loaded with nicotine are operable to form a gel in contact with the oral mucosa when hydrated with saliva, wherein the plurality of particles consisting of the at least one water-soluble anionic mucoadhesive polymer loaded with nicotine are operable to protect the biologically active compound until adherence to the oral mucosa, and wherein the weight ratio of the at least one water-soluble anionic mucoadhesive polymer to nicotine is from 2:1 to 20:1 (‘643 at claim 14). The reference patent recites wherein the powder composition is included in a sachet (‘643 at claim 15). The reference patent recites wherein the ion-exchange composition ii) is made by providing a water slurry of the at least one water-soluble anionic mucoadhesive polymer, adding nicotine, and evaporating water from the slurry to obtain a final water content below 10% by weight of the ion exchange composition (‘643 at claim 16). The reference patent recites wherein the ion-exchange composition ii) is made by providing a water dispersion of the at least one water-soluble anionic mucoadhesive polymer, adding nicotine, and precipitating the composition from the dispersion by means of a suitable agent to obtain a final water content below 10% by weight of the ion exchange composition (‘643 at claim 17). The reference patent recites powder composition comprising: i) a sugar alcohol composition in powder form comprising one or more sugar alcohol particles selected from the group consisting of sorbitol particles, erythritol particles, xylitol particles, lactitol particles, maltitol particles, mannitol particles, isomalt particles, and combinations thereof, in an amount of at least 60% by weight of the powder composition; and ii) an ion-exchange composition in powder form for oromucosal delivery of nicotine, the ion-exchange composition comprising: a plurality of particles consisting essentially of at least one polacrilex resin loaded with nicotine, the polacrilex resin loaded with nicotine being at least partly coated with at least one water-soluble anionic mucoadhesive polymer, wherein the at least one water-soluble anionic mucoadhesive polymer is selected from sulfonated polysaccharides, anionic polysaccharides, polyacrylic acid, and combinations thereof, wherein the at least one water-soluble anionic mucoadhesive polymer is operable to form a gel in contact with the oral mucosa when hydrated with saliva, wherein the at least one water-soluble anionic mucoadhesive polymer is operable to protect the nicotine until adherence to the oral mucosa, and wherein the weight ratio of the at least one water-soluble anionic mucoadhesive polymer to nicotine is from 2:1 to 20:1 (‘643 at claim 18).
Reference claims effectively anticipate the instant claims resulting in a prima facie case of anticipatory type non-statutory double patenting.
E) Claims 1-30 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 134-156 of copending Application No.18/876,619 in view of Turner et al (US Patent Publication 2016/0263170 A1) and Geonnotti et al (US Patent Application Publication 2018/0140521A1). The instant application recites a powder mixture, the powder mixture having a Hausner ratio of 1.00 to 1.59 and comprising a population of particles and one or more active ingredients, the population of particles including at least two types of sugar alcohol particles selected from the group consisting of i) non-directly compressible (non-DC) sugar alcohol particles, ii) directly compressible (DC) sugar alcohol particles that are not granulated sugar alcohol particles, and iii) granulated sugar alcohol particles, wherein:at least one of said at least two types of sugar alcohol particles having a particle size withmore than 50% of the particles being below 250 microns; andat least one of said at least two types of sugar alcohol particles being present in an amount of at least 20% by weight of the powder mixture(Instant application at claim 1).
The reference application recites a flowpack for oral delivery of active pharmaceutical ingredients, the flowpack comprising a flowable population of particles comprising: a first type of particles comprising one or more distinct portions of particles with a content of one or more active pharmaceutical ingredients in an amount of 20 to 70%o by weight of the population of particles and a carrier for the one or more active pharmaceutical ingredients; a second type of particles in an amount of 30-95%0 by weight of the population of particles separate from the first type of particles, the second type of particles comprising at least 9500 by weight of one or more sweeteners; and a third type of particles in an amount of 1-10% by weight of the population of particles separate from the first and second type of particles, the third type of particles comprising flavor (‘619 at claim 134). The reference application recites wherein the flowable population of particles is a free-flowing population of particles (‘619 at claim 135). The reference application recites wherein the one or more sweeteners of the second type of particles comprises non-directly compressible (non-DC) sweetener particles (‘619 at claim 136). The reference application recites wherein the one or more sweeteners of the second type of particles comprises one or more sugar alcohols selected from the group consisting of erythritol, maltitol, xylitol, isomalt, lactitol, mannitol, sorbitol, and combinations thereof (‘619 at claim 137). The reference application recites wherein the one or more sweeteners of the second type of particles comprises one or more saccharides selected from the group consisting of dextrose, saccharose, dextrin, trehalose, fructose, and combinations thereof (‘619 at claim 138). The reference application recites wherein the third type of particles comprises a powder flavor (‘619 at claim 139). The reference application recites wherein the third type of particles has a load of flavor in a range of 5-25% (‘619 at claim 140). The reference application recites wherein one or more distinct portions of particles of the first type of particles is present in an amount of 30-60% by weight of the population of particles (‘619 at claim 141). The reference application recites wherein the one or more active pharmaceutical ingredients is selected from the group consisting of diphenhydramine, cetirizine, loratadine, chlorpheniramine maleate, levocetirizine, meclizine, dextromethorphan, phenylephrine, famotidine, omeprazole, doxylamine succinate, melatonin, and any combination and mixture thereof (‘619 at claim 142). The reference application recites wherein the one or more active pharmaceutical ingredients is selected from the group consisting of diphenhydramine, fexofenadine, dimenhydrinate, meclizine, pseudoephedrine, aspirin, caffeine, theanine, and any combination and mixture thereof (‘619 at claim 143). The reference application recites wherein the one or more active pharmaceutical ingredients is present in an amount of 20-40% by weight of the population of particles (‘619 at claim 144). The reference application recites wherein the one or more active pharmaceutical ingredients is selected from the group consisting of fexofenadine, guaifenesin, calcium carbonate, magnesium hydroxide, acetaminophen, aspirin, ibuprofen, naproxen sodium, caffeine, and any combination and mixture thereof (‘619 at claim 145). The reference application recites wherein the one or more active pharmaceutical ingredients is present in an amount of 30-70% by weight of the population of particles (‘619 at claim 146). The reference application recites wherein a series of at least 5 samples of the population of particles each having the same fixed weight in the range of 0.5-2 g comprises the one or more active pharmaceutical ingredients in an amount varying with a relative standard deviation (RSD) below 10% (‘619 at claim 147). The reference application recites wherein the first, second and third type of particles have an average particle size difference of at most 200 microns (‘619 at claim 148). The reference application recites wherein the one or more active pharmaceutical ingredients is microencapsulated (‘619 at claim 149). The reference application recites wherein the one or more active pharmaceutical ingredients is granulated with the carrier (‘619 at claim 150). The reference application recites wherein the carrier for the one or more active pharmaceutical ingredients comprises microcrystalline cellulose and starch (‘619 at claim 151). The reference application recites wherein the carrier for the one or more active pharmaceutical ingredients comprises one or more sugar alcohols selected from the group consisting of erythritol, maltitol, xylitol, isomalt, lactitol, mannitol, sorbitol, and combinations thereof (‘619 at claim 152). The reference application recites wherein the carrier for the one or more active pharmaceutical ingredients comprises one or more binders selected from the group consisting of hydroxypropyl cellulose (HPC), hydroxypropylmethyl cellulose (HPMC), carboxymethyl cellulose (CMC), low substituted hydroxypropyl cellulose (L-HPC), polyvinylpyrrolidone (PVP), copovidone, and any mixture and combination thereof (‘619 at claim 153). The reference application recites wherein the flowable population of particles further comprises a disintegrant (‘619 at claim 154). The reference application recites a flowpack for oral delivery of active ingredients comprising a population of particles, an outer package material enclosing the population of particles, the population of particles comprising: a first type of particles comprising one or more distinct portions of particles with a content of one or more active pharmaceutical ingredients in an amount of 40 to 60% by weight of the population of particles and a carrier for the one or more active pharmaceutical ingredients; a second type of particles in an amount of 30-95% by weight of the population of particles separate from the first type of particles, the second type of particles comprising at least 95% by weight of one or more sweeteners; and a third type of particles in an amount of 1-10% by weight of the population of particles separate from the first and second type of particles, the third type of particles comprising flavor (‘619 at claim 155). The reference application recites a flowpack for oral delivery of active ingredients comprising a population of particles, an outer package material enclosing the population of particles, the population of particles comprising: a first type of particles comprising one or more distinct portions of particles with a content of one or more active pharmaceutical ingredients and a carrier for the one or more active pharmaceutical ingredients; a second type of particles in an amount of 30-95% by weight of the population of particles separate from the first type of particles, the second type of particles comprising at least 95% by weight of one or more sweeteners; and a third type of particles in an amount of 1-10% by weight of the population of particles separate from the first and second type of particles, the third type of particles comprising flavor (‘619 at claim 156).
The reference application differs from the instant claim insofar as it teaches a powder with sugar alcohol but it is not specific as to the size of the sugar alcohol particles.
The teachings of Turner and Geonnotti are discussed above.
Generally, it is prima facie obvious to select a known material (e.g.the sugar alcohols of differing particle size) for incorporation into a composition, based on its recognized suitability for its intended use (a oral powder). See MPEP 2144.07. The reference application teaches the use of at least two types of sugar alcohol particles with different particle size distributions but does not specify size. It would be prima facie obvious to select the sugar alcohols of a similar oral powder composition (Turner) with a known size distribution to use in the reference application as the specific sizes are taught by Turner to be useful in the intended use as an oral powder.
This is a provisional nonstatutory double patenting rejection.
Reference claims and prior art combine to produce a prima facie case of obviousness type non-statutory double patenting.
F) Claims 1-30 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-23 of copending Application No.18/894,764 in view of Turner et al (US Patent Publication 2016/0263170 A1) and Geonnotti et al (US Patent Application Publication 2018/0140521A1). The instant application recites a powder mixture, the powder mixture having a Hausner ratio of 1.00 to 1.59 and comprising a population of particles and one or more active ingredients, the population of particles including at least two types of sugar alcohol particles selected from the group consisting of i) non-directly compressible (non-DC) sugar alcohol particles, ii) directly compressible (DC) sugar alcohol particles that are not granulated sugar alcohol particles, and iii) granulated sugar alcohol particles, wherein:at least one of said at least two types of sugar alcohol particles having a particle size withmore than 50% of the particles being below 250 microns; andat least one of said at least two types of sugar alcohol particles being present in an amount of at least 20% by weight of the powder mixture(Instant application at claim 1).
The reference application recites method of generating fluid in the oral cavity, comprising the steps of: a) providing a swishable powder delivery system having a content of at least two types of sugar alcohol particles with different particle size distributions and one or more active ingredients, the powder delivery system being a dry and flowable population of particles in solid form; and b) swishing said dry and flowable population of particles in solid form by at human subject without adding water (‘764 at claim 1). The reference application recites wherein swishing said powder delivery system is characterised by forcing the powder delivery system around the oral cavity for at least 5 seconds (‘764 at claim 2). The reference application recites wherein at least one of the at least two types of sugar alcohol particles with different particle size distributions is substantially free flowing (‘764 at claim 3). The reference application recites wherein the Hausner ratio of the powder delivery system is between 1.00 and 1.59 (‘764 at claim 4). The reference application recites wherein more than 1.5 mL fluid is generated in the oral cavity within a period from 30 to 90 seconds from onset of swishing (‘764 at claim 5). The reference application recites wherein the powder delivery system provides an improved cooling effect compared to a powder delivery system without at least one of the at least two types of sugar alcohol particles with different particle size distributions (‘764 at claim 6). The reference application recites wherein the powder delivery system provides an improved watering effect compared to a powder delivery system without at least one of the at least two types of sugar alcohol particles with different particle size distributions (‘764 at claim 7). The reference application recites wherein the powder delivery system provides an improved mouthfeel compared to a powder delivery system without at least one of the at least two types of sugar alcohol particles with different particle size distributions, the improved mouthfeel including at least one of less sandy mouthfeel, less dusty mouthfeel, less roughness mouthfeel, less sticky or improved texture (‘764 at claim 8). The reference application recites wherein the population of particles includes at least two types of sugar alcohol particles comprising i) granulated sugar alcohol particles and ii) non-directly compressible (non-DC) sugar alcohol particles (‘764 at claim 9). The reference application recites wherein the population of particles includes at least two types of sugar alcohol particles comprising i) granulated sugar alcohol particles and iii) directly compressible (DC) sugar alcohol particles that are not granulated sugar alcohol particles (‘764 at claim 10). The reference application recites wherein the population of particles includes at least two types of sugar alcohol particles comprising ii) non-directly compressible (non-DC) sugar alcohol particles and iii) directly compressible (DC) sugar alcohol particles that are not granulated sugar alcohol particles (‘764 at claim 11). The reference application recites wherein the population of particles includes at least three types of sugar alcohol particles comprising i) granulated sugar alcohol particles, ii) non-directly compressible (non-DC) sugar alcohol particles and iii) directly compressible (DC) sugar alcohol particles that are not granulated sugar alcohol particles (‘764 at claim 12). The reference application recites wherein the population of particles includes at least two types of sugar alcohol particles comprising i) granulated sugar alcohol particles and ii) non-directly compressible (non-DC) sugar alcohol particles in a weight ratio between i) and ii) of between 0.2 and 5 (‘764 at claim 13). The reference application recites wherein the population of particles includes at least two types of sugar alcohol particles comprising i) granulated sugar alcohol particles and iii) directly compressible (DC) sugar alcohol particles that are not granulated sugar alcohol particles in a weight ratio between i) and iii) of between 0.2 and 5 (‘764 at claim 14). The reference application recites wherein the population of particles includes at least two types of sugar alcohol particles comprising ii) non-directly compressible (non-DC) sugar alcohol particles and iii) directly compressible (DC) sugar alcohol particles that are not granulated sugar alcohol particles in a weight ratio between ii) and iii) of between 0.2 and 5 (‘764 at claim 15). The reference application recites wherein the active ingredient comprises an active nutraceutical ingredient and/or a dietary supplement and/or oral care agents (‘764 at claim 16). The reference application recites wherein the active ingredient comprises oral care agents including one or more probiotic agents (‘764 at claim 17). The reference application recites wherein the active ingredient comprises oral care agents including zinc acetate and/or zinc gluconate (‘764 at claim 18). The reference application recites wherein the active ingredient comprises oral care agents for oral care benefits including bad breath, plaque, gingivitis, whitening, or combinations of two or more thereof (‘764 at claim 19). The reference application recites wherein the active ingredient comprises anti-septics including cetyl pyridinium chloride (CPC) and/or essential oils selected from the group consisting of cineole, menthol, methyl salicylate, thymol, and any combination thereof (‘764 at claim 20). The reference application recites wherein the swishable powder further comprises abrasive agents, including calcium carbonate and/or talc (‘764 at claim 21). The reference application recites wherein the swishable powder further comprises flow promoting agents, including silicon dioxide and/or rice hulles and/or cellulosic fibers (‘764 at claim 22). The reference application recites wherein the active ingredient is seleted from active ingredients for the throat selected from the group consisting of a cetylcysteine, ambroxol, amylmetacresol, benzocaine, bisacodyl, bismuth subsalicylate, bromhexine, cetirizine, cetylpyridinium, chlorhexidine, dextromethorphan hydrobromide, 2,4-dichlorobenzyl alcohol, doxylamine succinate, eucalyptus oil, flurbiprofen, glycerin, hexylresorcinol, lidocaine, menthol, myrrh, paracetamol, pectin, peppermint oil, phenol, phenylephrine, povidone-iodine, pseudoephedrine, ranitidine, simethicone, sodium docusate, spearmint, zinc, or any combination thereof; active ingredients for the gastrointestinal tract selected from alginate, atenolol, aspirin (acetylsalicylic acid), ampicillin, aminosalicylates, anhydrous citric acid, aspirin, bisacodyl, bismuth subsalicylate, bupropion, caffeine, calcium, calcium carbonate, cetirizine, cimetidine, cisapride, clarithromycin, desloratadine, dexlansoprazole, diphenhydramine HCl, diphenhydramine citrate, dimenhydrinate, docusate erythromycin, dopamine, esomeprazole, famotidine, fexofenadine HCl, guaifenesin, hydrotalcite, ibuprofen, ketoprofen, lactase enzyme, lansoprazole, loratadine, lorcaserin, loperamide, loperamide HCl, magnesium, magnesium carbonate, magnesium hydroxide, melatonin, methamphetamine HCl, metoclopramide, metronidazole, montelukast, mycostatin, naltrexone, naproxen, naproxen sodium, nizatidine, omeprazole, ondansetron, orlistat, pantoprazole, paracetamol (acetaminophen), pectin, phentermine HCl, polypodium leucotomos, prednisolone, prednisone, progesterone, propranolol, propantheline bromide, pseudoephedrine HCl, phentermine, rabeprazole, ranitidine, roflumilast, scopoloamine butyl hydroxide, simethicone, sodium, sodium bicarbonate, sodium docusate, sumatriptan, testosterone, tetracycline, topiramate, vitamin A, vitamin B, vitamin B12, vitamin C (ascorbic acid), vitamin D, and vitamin E, vitamin K, or any combination thereof, and active ingredients for buccal absorption selected from atenolol, baclofen, caffeine, carvedilol, chlorpheniramine, chlorpheniramine maleate, fluticasone propionate, maleate, desmopressin, diltiazem hydrochloride, doxylamine succinate, mycostatin, nicotine, nifedipine, nitroglycerin, omeprazole, ondansetron, oxymetazoline HCl, oxytocin, phenylephrine, piroxicam, prednisone, propranolol, salbutamol sulphate, scopoloamine butyl hydroxide, sumatriptan, triamcinolonacetonid, and any combination thereof (‘764 at claim 23).
The reference application differs from the instant claim insofar as the reference application does not teach a size for the sugar alcohol particles. The teachings of Turner and Geonnotti cure this deficit.
The teachings of Turner and Geonnotti are discussed above.
Generally, it is prima facie obvious to select a known material (e.g.the sugar alcohols of differing particle size) for incorporation into a composition, based on its recognized suitability for its intended use (a mouthwash or oral care powder). See MPEP 2144.07. The reference application teaches the use of at least two types of sugar alcohol particles with different particle size distributions but does not specify size. It would be prima facie obvious to select the sugar alcohols of a similar powder oral care composition (Turner) with a known size distribution to use in the reference application as the specific sizes are taught by Turner to be useful in the intended use as a powder mouthwash.
This is a provisional nonstatutory double patenting rejection.
Reference claims and prior art combine to produce a prima facie case of obviousness type non-statutory double patenting.
Conclusion
No claims are presently allowable.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMANDA MICHELLE PETRITSCH whose telephone number is (571)272-6812. The examiner can normally be reached M-F 08:30-17:00 EST ALT Fridays.
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, Sahana S. Kaup, can be reached at 571-272-6897. 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.
/AMANDA MICHELLE PETRITSCH/Examiner, Art Unit 1612
/SAHANA S KAUP/Supervisory Primary Examiner, Art Unit 1612
Prosecution Insights