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 DKPA202070298 filed 05/08/2020. The instant application is a CON of 17/245,330 filed 04/30/2021.
Information Disclosure Statement
The information disclosure statement (IDS) dated 09/24/2024 complies with provisions of 37 CFR 1.97, 1.98 and MPEP §609. Accordingly, it has been placed in the application file and the information therein has been considered as to the merits.
Claim Interpretation
With regards to claim 1 section b) the Examiner is interpreting the term “by at human subject” as a simple typo of “by a human subject”.
With regards to components followed by parenthetical descriptors in claims 9-15, 20, 23, examples including directly compressible (DC) or cetyl pyridinium chloride (CPC) or vitamin C (ascorbic acid), the Examiner understands that these are common alternate names or short-hands 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.
Claim Objections
Claim 1 is objected to because of the following informalities: typographical error. Appropriate correction is required. Examiner is interpreting the term “by at human subject” as a simple typo of “by a human subject”.
Claim 5 is objected to because of the following informalities: grammar. Appropriate correction is required. The Examiner recommends changing “more than 1.5mL fluid is generated” to “more than 1.5mL of fluid is generated”
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.
Claim 23 is 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 23 recites the use of aspirin twice when listing active ingredients for the gastrointestinal tract. It is presently unclear if the second aspirin is intended to denote a different aspirin containing composition or if it was a typographical error.
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 1-3, 5, 8-12, 16, and 19-23 are rejected under 35 U.S.C. 103 as being unpatentable over Bartlett (WO 94/12150), in view of Cullup et al. (US Patent Application Publication 2009/0172902 A1) and Kashid et al. (WO 2007074472 A2).
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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).
Bartlett differs from instant claim 1 insofar as it does not disclose that the powder is dissolved by the user’s mouth. The teaching of Cullup cure this deficit.
Cullup teaches a dried powder mouthwash which is activated by the user’s saliva (Cullup at abstract).
The combined teachings of Bartlett and Cullup differ from instant claim 1 insofar as they do not disclose that the sugar alcohol particles have different sizes. The teachings of Kashid cure this deficit.
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).
Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use. See MPEP 2144.07. Bartlett and Cullup et al. disclose wherein the disintegrating oral powder composition comprises sugar alcohol particles, but does not disclose a range of particle sizes. Accordingly, it would have been obvious to one of ordinary skill in the art to have formulated the sugar alcohol particles of Bartlett and Cullup et al. to have the size range taught in Kashid since those sizes are a known and effective range of sizes for sugar alcohol particles used in disintegrating oral powder compositions as taught by Kashid.
Regarding instant claim 1, Cullup teaches a dried powder mouthwash which is activated by the user’s saliva. Bartlett teaches that the mouthwash may be diluted before use (Bartlett at page 9 lines 12-21). Kashid teaches that the composition can also be converted into other dosage forms like dispersible tablets, granules (aka powder), and sachets containing such granules (Kashid page 6, paragraph 2).
Regarding instant claim 2, Kashid teaches that the composition dissolves in 60 seconds or less (Kashid claim 10) and preferably 30 seconds or less (Kashid at page 2, paragraph 1). The ranges provided by Kashid for the rate of dissolving overlap with the instantly claimed ranges of time to move the particles in the mouth. When the tablet is dissolved or granules are dissolved into saliva, an aqueous liquid is created with saliva given water is the primary component of saliva. 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, 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).
Regarding instant claim 5, Kashid teaches that the composition dissolves in 60 seconds or less (Kashid claim 10) and preferably 30 seconds or less (Kashid at page 2, paragraph 1). The ranges provided by Kashid for the rate of dissolving overlap with the instantly claimed ranges of time to move the particles in the mouth. When the tablet is dissolved or granules are dissolved into saliva, an aqueous liquid is created with saliva given water is the primary component of saliva. 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, Kashid teaches that the composition would have minimum grit or less of a sandy effect (Kashid at page 4 lines 11-13).
Regarding instant claim 9, Kashid teaches that the composition may include xylitol, mannitol, lactitol, erythritol, and maltitol (Kashid at page 7 lines 27-30). Bartlett teaches the use of sorbitol (Bartlett at page 7 lines 27-32 and Examples 22-24) and xylitol (Examples 22-24).
Regarding instant claim 10, Kashid teaches that the composition may include xylitol, mannitol, lactitol, erythritol, and maltitol (Kashid at page 7 lines 27-30). Bartlett teaches the use of sorbitol (Bartlett at page 7 lines 27-32 and Examples 22-24) and xylitol (Examples 22-24).
Regarding instant claim 11, Kashid teaches that the composition may include xylitol, mannitol, lactitol, erythritol, and maltitol (Kashid at page 7 lines 27-30). Bartlett teaches the use of sorbitol (Bartlett at page 7 lines 27-32 and Examples 22-24) and xylitol (Examples 22-24).
Regarding instant claim 12, Kashid teaches that the composition may include xylitol, mannitol, lactitol, erythritol, and maltitol (Kashid at page 7 lines 27-30). Bartlett teaches the use of sorbitol (Bartlett at page 7 lines 27-32 and Examples 22-24) and xylitol (Examples 22-24).
Regarding instant claim 16, Bartlett teaches that the composition teaches the use of menthol and cetyl pyridium chloride (Bartlett at Examples 22-24).
Regarding instant claim 19, Bartlett teaches the use of whitening agents (Bartlett at page 10 lines 15-23).
Regarding instant claim 20, Bartlett teaches that the composition teaches the use of menthol and cetyl pyridium chloride (Bartlett at Examples 22-24).
Regarding instant claim 21, Kashid teaches the use of talc (Kashid at page 9 lines 15-16) and calcium carbonate (page 9 lines 29-31).
Regarding instant claim 22, Kashid teaches the use of silicon dioxide (Kashid at page 11 lines 1-5).
Regarding instant claim 23, Bartlett teaches that the composition teaches the use of menthol and cetyl pyridium chloride (Bartlett at Examples 22-24).
II) Claims 6-7, 13-15, and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Bartlett (WO 94/12150), Cullup et al. (US Patent Application Publication 2009/0172902 A1) and Kashid et al. (WO 2007074472 A2) as applied to claims 1-3, 5, 8-12, 16, and 19-23 above, and further in view of Geonnotti et al (US Patent Application Publication 2018/0140521A1).
The teachings of Bartlett, Cullup and Kashid are discussed above.
The combined teachings of Bartlett, Cullup and Kashid differ from that of claim 6 insofar as they do not disclose that any of the ingredients have a cooling effect. The teachings of Geonnotti cure this deficit. Purely en arguendo, and in regard to this ground of rejection only, the examiner understands Bartlett, Cullup, and Kashid to fail to teach the required ratio between particles
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]).
Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use. See MPEP 2144.07. Bartlett, Cullup and Kashid disclose wherein the liquid producing oral care composition comprises sugar alcohol particles, but does not disclose a ratio between particles. Accordingly, it would have been obvious to one of ordinary skill in the art to have formulated the sugar alcohol particles of Bartlett, Cullup and Kashid to have the ratios between particle types of Geonnotti since those ratios are known and effective ratios for sugar alcohol particles used in liquid producing oral care compositions as taught by Geonnotti.
Regarding instant claim 5, 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]). Kashid teaches that the composition dissolves in 60 seconds or less (Kashid claim 10) and preferably 30 seconds or less (Kashid at page 2, paragraph 1). The ranges provided by Kashid for the rate of dissolving overlap with the instantly claimed ranges of time to move the particles in the mouth. When the tablet is dissolved or granules are dissolved into saliva, an aqueous liquid is created with saliva given water is the primary component of saliva. 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 6, Bartlett teaches that the composition teaches the use of menthol and cetyl pyridium chloride (Bartlett at Examples 22-24). Geonnotti further teaches the use of eucalyptol and menthol as cooling agents (Geonnotti at [0023]).
Regarding instant claim 7, 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]).
Regarding instant claim 13-15, Kashid teaches a dissolving or disintegrating oral pharmaceutical comprising an active, one or more fillers larger than 150 microns (Kashid claim 1). Kashid further teaches the use of directly compressible, non-directly compressible and granulated sugar alcohol particles. 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]). These ranges would overlap with the instantly claimed particle sizes and ratios between DC and non-DC sugar alcohol particles. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP§2144.05(I).
Regarding instant claim 17, 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]).
III) Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Bartlett (WO 94/12150), Cullup et al. (US Patent Application Publication 2009/0172902 A1) and Kashid et al. (WO 2007074472 A2) as applied to claims 1-3, 5, 8-12, 16, and 19-23 above, and further in view of Perez et al (US Patent Application Publication 20160000695 A1).
The teachings of Bartlett, Cullup, and Kashid are discussed above.
The teachings of Bartlett, Cullup, and Kashid differ from that of instant claim 18 in that they do not teach the use of zinc gluconate. The teachings of Perez et al. cure this deficit.
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]).
Perez does not teach the use of multiple sugar alcohol particles only the use of xylitol. The teachings of Bartlett, Cullup, and Kashid cure this deficit.
It would have been prima facie obvious for one of ordinary skill in the art to have combined composition of Bartlett, Cullup, and Kashid with the zinc gluconate of Perez for the predictable result of a mouthwash powder. See MPEP § 2143 (A). One would have been motivated to include the zinc gluconate in the composition of Bartlett, Cullup, and Kashid for the benefit of treating bad breath.
IV) Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Bartlett (WO 94/12150), Cullup et al. (US Patent Application Publication 2009/0172902 A1), Perez et al (US Patent Application Publication 20160000695 A1), and Kashid et al. (WO 2007074472 A2) as applied to claims 1-3, 5, 8-12, 16, and 18-23 above, and further in view of Turner et al (US Patent Publication 2016/0263170 A1).
The teachings of Bartlett, Cullup, Kashid, and Perez are discussed above.
The teachings of Bartlett, Cullup, Kashid, and Perez differ from that of instant claim 4 in that they do not mention a Hausner ratio for the composition. The teachings of Turner et al. cure this deficit.
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 et al. differs from the instant claims insofar as it does not teach that the powder is moved around the oral cavity.
Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use. See MPEP 2144.07. Bartlett, Cullup, Kashid, and Perez disclose wherein the sugar alcohol composition comprises dry powdered particles, but does not disclose a Hausner ratio. Accordingly, it would have been obvious to one of ordinary skill in the art to have formulated the dry freely-flowing powder particles of Perez to have a Hausner ratio of less than 1.5 since that ratio is a known and effective ratio for particles used in freely-flowing compositions as taught by Turner.
Regarding instant claim 4, Bartlett, Cullup and Kashid teach dry powders that are used as powders. Perez teaches that the powder form of the composition before tableting is a free-flowing powder (Perez at [0054-0055]). 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. See MPEP §2144.05(I) stating that where claimed ranges overlap with prior art ranges, a prima facie case of obviousness exists.
V) Claims 1-23 are rejected under 35 U.S.C. 103 as being unpatentable over Bartlett (WO 94/12150), Cullup et al. (US Patent Application Publication 2009/0172902 A1) and Kashid et al. (WO 2007/074472 A2), Perez et al (US Patent Application Publication 20160000695 A1) and Turner et al (US Patent Publication 2016/0263170 A1) in further view of Geonnotti et al (US Patent Application Publication 2018/0140521A1).
The teachings of Bartlett, Cullup, Kashid, Perez, and Turner are discussed above.
The combined teachings of Bartlett, Kashid, Cullup, Perez, and Turner differ from that of instant claim 6 insofar as they do not disclose that any of the ingredients have a cooling effect. The teachings of Geonnotti cure this deficit.
The teachings of Geonotti are discussed above.
The teachings of Geonotti differ from that of instant claim 1 insofar as they do not disclose that the product is a powder. Purely en arguendo, and in regard to this ground of rejection only, the examiner understands Bartlett, Cullup, and Kashid to fail to teach the required ratio between particles. The teachings of Bartlett, Kashid, Cullup, Perez, and Turner cure this deficit.
Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use. See MPEP 2144.07. Bartlett, Cullup, Kashid, Perez and Turner disclose wherein the liquid producing oral care composition comprises sugar alcohol particles, but does not disclose a ratio between particles. Accordingly, it would have been obvious to one of ordinary skill in the art to have formulated the sugar alcohol particles of Bartlett, Cullup, Kashid, Perez and Turner to have the ratios between particle types of Geonnotti since those ratios are known and effective ratios for sugar alcohol particles used in liquid producing oral care compositions as taught by Geonnotti.
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 1-23 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-29 of U.S. Patent No. 12,128,138 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the reference patent requires the administration of the particles to the oral cavity of a human subject which is not required by the instant application. The instant application recites a 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.
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 1-23 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 in view of Cullup et al. (US Patent Application Publication 2009/0172902 A1). The instant application recites a 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.
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).
The reference patent differs from the instant application insofar as it does not teach a method of using the oral care composition. The teachings of Cullup cure this deficit.
Cullup teaches a planar blank is made of disposable paper and embedded with dry toothpaste or mouthwash which is activated by the user's saliva when used (Cullup at abstract).
It would have been prima facie obvious to have used an oral care composition in the oral cavity as taught by Cullup. See MPEP 2144.07.
Reference claims and prior art combine to produce a prima facie case of obviousness type non-statutory double patenting.
C) Claims 1-23 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 in view of Cullup et al. (US Patent Application Publication 2009/0172902 A1). The instant application recites a 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.
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).
The reference patent differs from the instant application insofar as it does not teach a method of using the oral care composition. The teachings of Cullup cure this deficit.
Cullup teaches a planar blank is made of disposable paper and embedded with dry toothpaste or mouthwash which is activated by the user's saliva when used (Cullup at abstract).
It would have been prima facie obvious to have used an oral care composition in the oral cavity as taught by Cullup. See MPEP 2144.07.
Reference claims and prior art combine to produce a prima facie case of obviousness type non-statutory double patenting.
D) Claims 1-23 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of copending Application No. 19/046,728 in view of Cullup et al. (US Patent Application Publication 2009/0172902 A1). The instant application recites a 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.
The reference 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 (‘728 at claim 1). The reference application recites wherein at least one of i) or ii) having a particle size with more than 50% of the particles being below 250 microns (‘728 at claim 2). The reference application 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 being present in an amount of at least 20% by weight of the powder mixture (‘728 at claim 3). The reference application 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 (‘728 at claim 4). The reference application 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 (‘728 at claim 5). The reference application recites wherein 2 at least one of said at least two types of sugar alcohol particles comprises i) non-directly compressible (non-DC) sugar alcohol particles; and at least i) having a particle size with more than 50% of the particles being below 250 microns (‘728 at claim 6). The reference application 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; 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 (‘728 at claim 7). The reference application 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 least20% by weight of the powder mixture (‘728 at claim 8). The reference application 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 (‘728 at claim 9). The reference application 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; and at least ii) having a particle size with more than 50% of the particles being below 250microns (‘728 at claim 10). The reference application 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; and 3 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 [east 20% by weight of the powder mixture (‘728 at claim 11). The reference application 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 (‘728 at claim 12). The reference application recites wherein at least 50% by weight of said at least two types of sugar alcohol particles have a particle size below 250 microns (‘728 at claim 13). The reference application recites wherein the population of particles includes at least 20% of one type of sugar alcohol particles having a particle size with more than80% 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 (‘728 at claim 14). The reference application recites wherein the population of particles includes i) non-directly compressible (non-DC) sugar alcohol particles and iii) granulated sugar alcohol particles (‘728 at claim 15). The reference application 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 (‘728 at claim 16). The reference application 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 (‘728 at claim 17). The reference application 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 (‘728 at claim 18). The reference application 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 and combinations thereof (‘728 at claim 19). The reference application recites wherein i) and ii) having both a particle size with more than 50% of the particles being below 250 microns (‘728 at claim 20). The reference application recites 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 (‘728 at claim 21). The reference application recites wherein i) and ii) being both present in an amount of at least 20% by weight of the powder mixture (‘728 at claim 22). The reference application recites wherein the one or more active ingredients comprises zinc acetate and/or zinc gluconate and/or zinc citrate (‘728 at claim 23). The reference application 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 (728 at claim 24). The reference application recites wherein the one or more active ingredients comprises oral care agents for oral care benefits including one or more probiotic agents (‘728 at claim 25). The reference application recites wherein the one or more active ingredients comprises anti-septics including cetyt pyridinium chloride (CPC) and/or essential oils selected from the group consisting of cineole, menthol, methyl salicylate, thymol, and any combination thereof (‘728 at claim 26). The reference application recites further comprising flow promoting agents including one or more of silicon dioxide, rice hulls, and cellulosic species (‘728 at claim 27). The reference 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 (‘728 at claim 28). The reference application 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 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 particle (‘728 at claim 29). The reference application 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 being present in an amount of at least 20% by weight of the powder mixture (‘728 at claim 30).
The reference application differs from the instant application insofar as it does not teach a method of using the oral care composition. The teachings of Cullup cure this deficit.
Cullup teaches a planar blank is made of disposable paper and embedded with dry toothpaste or mouthwash which is activated by the user's saliva when used (Cullup at abstract).
It would have been prima facie obvious to have used an oral care composition in the oral cavity as taught by Cullup. See MPEP 2144.07.
Reference claims and prior art combine to produce a prima facie case of obviousness type non-statutory double patenting.
This is a provisional nonstatutory double patenting rejection.
E) Claims 1-23 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 Cullup et al. (US Patent Application Publication 2009/0172902 A1). The instant 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.
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 application insofar as it does not teach a method of using the oral care composition. The teachings of Cullup cure this deficit.
Cullup teaches a planar blank is made of disposable paper and embedded with dry toothpaste or mouthwash which is activated by the user's saliva when used (Cullup at abstract).
It would have been prima facie obvious to have used an oral care composition in the oral cavity as taught by Cullup. See MPEP 2144.07.
Reference claims and prior art combine to produce a prima facie case of obviousness type non-statutory double patenting.
This is a provisional nonstatutory double patenting rejection.
Conclusion
No claims presently allowable.
Correspondence
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/AMANDA MICHELLE PETRITSCH/Examiner, Art Unit 1612
/SAHANA S KAUP/Supervisory Primary Examiner, Art Unit 1612
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