DETAILED ACTION
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on January 26th, 2024, has been entered.
Applicants' arguments, filed October 25th, 2024, have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
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 domestic priority to PRO 63/178,914 filed on 04/23/2021.
Claim Rejections - 35 USC § 103 - Obviousness
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 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.
A) Claims 1-2, 4-8, 11-15 and 21-22 are rejected under 35 U.S.C. 103 as being unpatentable over Swartz et al. (U.S. Patent App. Pub.2019/0343735 A1) in view of Shanler et al. (U.S. Patent App. Pub. 2013/0079379 A1).
Swartz recites two tables which disclose oral care embodiments comprising a sugar alcohol and a lubricant (see Tables 1 and 9). Swartz further recites the use of polyvinylpyrrolidone (Swartz in claim 13). Swartz teaches the use of poloxamers in combination with sodium lauryl sulfate and stearates in an amount between about 0.01% to about 20% by weight of the composition (Swartz at [0150-0162]). Swartz teaches that the composition may be a tablet or powder (Swartz at [0017], [0020], [0041]). Swartz further teaches the use of sugar alcohols (Swartz at [0108-0119]). Swartz recites Examples 1-6 which comprise a sugar alcohol, xylitol or sorbitol, and at least one anionic surfactant, sodium lauryl sulfate, which is a lubricant (Swartz at Tables 1 and 9). Swartz teaches wherein the oral care composition may include one or more surfactants at a level of from about 0.1% to about 15% (Swartz [0151]).
The teachings of Swartz differ from that of the instant claims insofar as Swartz does not specifically teach the use of preservatives nor specific poloxamers. The teachings of Shanler cure the deficit.
Shanler teaches a composition comprising gum disease and oral care agents that may be used to treat perioral dermatitis and other conditions (Shanler at [0138]). Shanler teaches that the composition may be administered orally (Shanler at [0091]). Shanler teaches the use of poloxamer 407 (Shanler at [0136]) and sorbitol (Shanler at [0154]). Shanler teaches a composition comprising 0.01% to 20% preservatives (Shanler at [0141]) and further recites sodium benzoate and potassium sorbate (Shanler at [0130]). Shanler teaches the composition may comprise two or more surfactants where each surfactant may be from about 0.5% to about 5% by weight of the composition (Shanler at [0150]).
The teaching of Shanler differ from that of the instant invention insofar as Shanler does not specifically teach that the composition is a tablet.
A person having ordinary skill in the art following the teaching of Swartz would have been motivated to have included the preservatives of Shanler for the benefit of a longer lasting product. One would have a reasonable expectation of success because both compositions comprise poloxamer, stearates, surfactants, and sugar alcohols. One would have a reasonable expectation of success because both Swartz and Shanler teach a gel composition. Swartz further teaches the same composition may be a gel or a tablet therefore one of ordinary skill in the art would understand how to transfer the composition of a gel into the form of a tablet as expected in Swartz.
Generally, it is prima facie obvious to select a known material such as the poloxamer 407 of Shanler for incorporation into a composition which is taught to include poloxamers such as that of Swartz, based on its recognized suitability for its intended use. See MPEP 2144.07.
Regarding instant claim 1, Swartz recites Examples 1-6 which comprise a sugar alcohol, xylitol or sorbitol, and at least one anionic surfactant, sodium lauryl sulfate, which is a lubricant (Swartz at Tables 1 and 9). Swartz teaches the use of poloxamers in combination with sodium lauryl sulfate and stearates in an amount between about 0.01% to about 20% by weight of the composition (Swartz at [0150-0162]). Swartz more specifically states the use of anionic surfactants, like poloxamers and stearates, in a range of about 0.1% to about 8% which is a narrower range (Swartz at [0150-0162]). The instant claims recite 0.01%-0.5% poloxamer, 1-5% anionic surfactant and 0.1-0.5% stearate. Swartz teaches wherein the oral care composition may include one or more surfactants at a level of from about 0.1% to about 15% (Swartz [0151]), which overlaps the instantly claimed range of 0.1 to 5%. Shanler teaches the composition may comprise two or more surfactants where each surfactant may be from about 0.5% to about 5% by weight of the composition (Shanler at [0150]), which overlaps the instantly claimed range of 0.1 to 5%. 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). Shanler teaches the use of sodium benzoate and potassium sorbate (Shanler at [0130]) as preservatives. Shanler teaches a composition comprising 0.01% to 20% preservatives (Shanler at [0141]) and further recites sodium benzoate and potassium sorbate (Shanler at [0130]), which overlaps with the instantly claimed range of 15-25% of sodium benzoate and 1-8% of potassium sorbate. 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 2, under the broadest reasonable interpretation the instant application did not specify the “sufficient amount” or the property that was stabilized within the composition therefore any amount of poloxamer including none would be considered “sufficient”.
Regarding instant claim 4, Swartz recites the use of polyvinylpyrrolidone (Swartz in claim 13).
Regarding instant claim 5, Swartz teaches the use of polyvinylpyrrolidone in an amount from about 0.1 to about 50% by weight of the oral care composition (Swartz at [0082-0103]). Swartz teaches the use of poloxamers in combination with sodium lauryl sulfate and stearates in an amount between about 0.01% to about 20% by weight of the composition (Swartz at [0150-0162]). Swartz more specifically states the use of anionic surfactants, like poloxamers and stearates in a range of about 0.1% to about 8% which is a narrower range (Swartz at [0150-0162]). Therefore, the ratio between the polyvinyl pyrrolidone and the poloxamer may overlap the instantly claimed range of 25:1 to 1:1. 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 6, Shanler teaches the use of poloxamer 407 (Shanler at [0136]). Generally, it is prima facie obvious to select a known material (e.g. the poloxamer 407 of Shanler for incorporation into a composition (that of Swartz), based on its recognized suitability for its intended use (a poloxamer in a personal care composition). See MPEP 2144.07.
Regarding instant claim 7, Swartz recites Examples 1-6 which comprise a sugar alcohol, xylitol or sorbitol (Swartz at Tables 1 and 9).
Regarding instant claim 8, Shanler teaches a composition comprising 0.01% to 20% preservatives (Shanler at [0141]) and further recites sodium benzoate and potassium sorbate (Shanler at [0130]), under the broadest reasonable interpretation the instant application did not specify the “sufficient amount” or the property that was stabilized within the composition therefore any amount of preservative including none would be considered “sufficient”.
Regarding instant claim 11, Swartz teaches that the composition may be a tablet or powder (Swartz at [0017], [0020], [0041]).
Regarding instant claim 12, Swartz recites Examples 1-6 which comprise polyvinyl alcohol (Swartz at Tables 1 and 9).
Regarding instant claim 13a-c, Swartz teaches the use of poloxamers in combination with sodium lauryl sulfate and stearates in an amount between about 0.01% to about 20% by weight of the composition (Swartz at [0150-0162]) which overlaps with the instantly claimed ranges of each of the lubricants of the instant application. Swartz more specifically states the use of anionic surfactants, like poloxamers and stearates in a range of about 0.1% to about 8% which is a narrower range (Swartz at [0150-0162]).The instant applicant recites 0.01%-0.5% poloxamer, 1-5% anionic surfactant and 0.1-0.5% stearate. 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). Shanler teaches the use of poloxamer 407 (Shanler at [0136]). Generally, it is prima facie obvious to select a known material (e.g. the poloxamer 407 of Shanler for incorporation into a composition (that of Swartz), based on its recognized suitability for its intended use (a poloxamer in a personal care composition). See MPEP 2144.07.
Regarding instant claim 13d, Swartz teaches the use of polyols including mannitol and sorbitol in an amount ranging between 2% to about 25% by weight of the oral care composition (Swartz at [0108-0119]) which overlaps with the instantly claimed range of about 15%-25%. 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 13e, Shanler teaches a composition comprising 0.01% to 20% preservatives (Shanler at [0141]) and further recites sodium benzoate and potassium sorbate (Shanler at [0130]), which overlaps with the instantly claimed range of 15-25% of sodium benzoate and 1-8% of potassium sorbate. 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 14, Swartz teaches the use of polyvinylpyrrolidone in an amount from about 0.1 to about 50% by weight of the oral care composition (Swartz at [0082-0103]) which overlaps the instantly claimed range of 2% to 6%. 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 15g, Swartz teaches the use of hydroxypropyl cellulose in an amount from 0.1% to 50% by weight of the composition (Swartz at [0082-0103]) which overlaps with the claimed range of 1% to 5%. 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 15h, Swartz teaches the use of multiple buffering agents including 0.5% to 75% of sodium carbonate (Swartz at [0121-0129]) and 0.005% to 10% of citric acid (Swartz at [0182-0186]) which overlaps with the instantly claimed range of 20-30% buffering agents. 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 15i, Swartz teaches the use of multiple buffering agents including 0.5% to 75% of sodium bicarbonate (Swartz at [0121-0129]) which overlaps with the instantly claimed 15-20% of carbonate. 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 21, Swartz teaches wherein the oral care composition may include one or more surfactants at a level of from about 0.1% to about 15% (Swartz [0151]), which overlaps the instantly claimed range of 0.3 to 3%. Shanler teaches the composition may comprise two or more surfactants where each surfactant may be from about 0.5% to about 5% by weight of the composition (Shanler at [0150]), which overlaps the instantly claimed range of 0.3 to 3%. 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 22 Swartz teaches wherein the oral care composition may include one or more surfactants at a level of from about 0.1% to about 15% (Swartz [0151]), which overlaps the instantly claimed range of 0.5 to 2.5%. Shanler teaches the composition may comprise two or more surfactants where each surfactant may be from about 0.5% to about 5% by weight of the composition (Shanler at [0150]), which overlaps the instantly claimed range of 0.5 to 2.5%. 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).
B) Claims 1-2, 4-8, 11-15 and 20-22 are rejected under 35 U.S.C. 103 as being unpatentable over Swartz et al. (U.S. Patent App. Pub.2019/0343735 A1) and Shanler et al. (U.S. Patent App. Pub. 2013/0079379 A1) in view of Wynn et al (US Patent App. Pub. 2004/0265373 A1).
The teachings of Swartz and Shanler are discussed above.
The teachings of Swartz and Shanler differ from instant claim 20 insofar as they do not explicitly teach the use of magnesium stearate. The teachings of Wynn cure this deficit.
Wynn teaches a solid tablet with immediate release in the mouth (Wynn at abstract). Wynn teaches the use of magnesium stearate as a lubricant in the tablet (Wynn at [0055]). Wynn teaches the use of pharmaceutically acceptable adjuvants including preservatives in a range of no more than about 25% of the composition (Wynn at [0058]). Wynn teaches the use of sugar alcohols including mannitol sorbitol and xylitol (Wynn at [0057]). Wynn teaches the use of polyvinyl pyrrolidone (Wynn at [0038]). Wynn teaches the use of ionic and non-ionic surfactants which would include anionic surfactants (Wynn at [0042]). Wynn teaches the use of celluloses (Wynn at abstract).
The teachings of Wynn differ from the instant claim insofar as they do not specifically teach potassium sorbate and sodium benzoate as preservatives. The teachings of Swartz and Shanler cure this deficit.
It would have been prima facie obvious to one of ordinary skill in the art to have used the magnesium stearate taught by Wynn for the magnesium ion source of Swartz. One would have been motivated to use magnesium stearate as the magnesium ion source because Wynn teaches magnesium stearate for its benefit as a lubricant in a tablet (Wynn at [0055]). One would have a reasonable expectation of success because Swartz teaches the use of a magnesium ion source in a tablet and Wynn teaches that magnesium stearate is a lubricant used in tablets.
Regarding instant claim 1, Swartz recites Examples 1-6 which comprise a sugar alcohol, xylitol or sorbitol, and at least one anionic surfactant, sodium lauryl sulfate, which is a lubricant (Swartz at Tables 1 and 9). Swartz teaches the use of poloxamers in combination with sodium lauryl sulfate and stearates in an amount between about 0.01% to about 20% by weight of the composition (Swartz at [0150-0162]). Swartz more specifically states the use of anionic surfactants, like poloxamers and stearates, in a range of about 0.1% to about 8% which is a narrower range (Swartz at [0150-0162]). The instant claims recite 0.01%-0.5% poloxamer, 1-5% anionic surfactant and 0.1-0.5% stearate. 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). Swartz teaches wherein the oral care composition may include one or more surfactants at a level of from about 0.1% to about 15% (Swartz [0151]), which overlaps the instantly claimed range of 0.1 to 5%. Shanler teaches the composition may comprise two or more surfactants where each surfactant may be from about 0.5% to about 5% by weight of the composition (Shanler at [0150]), which overlaps the instantly claimed range of 0.1 to 5%. 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). Shanler teaches the use of sodium benzoate and potassium sorbate (Shanler at [0130]) as preservatives. Shanler teaches a composition comprising 0.01% to 20% preservatives (Shanler at [0141]) and further recites sodium benzoate and potassium sorbate (Shanler at [0130]), which overlaps with the instantly claimed range of 15-25% of sodium benzoate and 1-8% of potassium sorbate. 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). Wynn teaches the use of pharmaceutically acceptable adjuvants including preservatives in a range of no more than about 25% of the composition (Wynn at [0058]).
Regarding instant claim 2, under the broadest reasonable interpretation the instant application did not specify the “sufficient amount” or the property that was stabilized within the composition therefore any amount of poloxamer including none would be considered “sufficient”.
Regarding instant claim 4, Swartz recites the use of polyvinylpyrrolidone (Swartz in claim 13).
Regarding instant claim 5, Swartz teaches the use of polyvinylpyrrolidone in an amount from about 0.1 to about 50% by weight of the oral care composition (Swartz at [0082-0103]). Swartz teaches the use of poloxamers in combination with sodium lauryl sulfate and stearates in an amount between about 0.01% to about 20% by weight of the composition (Swartz at [0150-0162]). Swartz more specifically states the use of anionic surfactants, like poloxamers and stearates in a range of about 0.1% to about 8% which is a narrower range (Swartz at [0150-0162]). Therefore, the ratio between the polyvinyl pyrrolidone and the poloxamer may overlap the instantly claimed range of 25:1 to 1:1. 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 6, Shanler teaches the use of poloxamer 407 (Shanler at [0136]). Generally, it is prima facie obvious to select a known material (e.g. the poloxamer 407 of Shanler for incorporation into a composition (that of Swartz), based on its recognized suitability for its intended use (a poloxamer in a personal care composition). See MPEP 2144.07.
Regarding instant claim 7, Swartz recites Examples 1-6 which comprise a sugar alcohol, xylitol or sorbitol (Swartz at Tables 1 and 9).
Regarding instant claim 8, Shanler teaches a composition comprising 0.01% to 20% preservatives (Shanler at [0141]) and further recites sodium benzoate and potassium sorbate (Shanler at [0130]), under the broadest reasonable interpretation the instant application did not specify the “sufficient amount” or the property that was stabilized within the composition therefore any amount of preservative including none would be considered “sufficient”.
Regarding instant claim 11, Swartz teaches that the composition may be a tablet or powder (Swartz at [0017], [0020], [0041]).
Regarding instant claim 12, Swartz recites Examples 1-6 which comprise polyvinyl alcohol (Swartz at Tables 1 and 9).
Regarding instant claim 13a-c, Swartz teaches the use of poloxamers in combination with sodium lauryl sulfate and stearates in an amount between about 0.01% to about 20% by weight of the composition (Swartz at [0150-0162]) which overlaps with the instantly claimed ranges of each of the lubricants of the instant application. Swartz more specifically states the use of anionic surfactants, like poloxamers and stearates in a range of about 0.1% to about 8% which is a narrower range (Swartz at [0150-0162]). The instant applicant recites 0.01%-0.5% poloxamer, 1-5% anionic surfactant and 0.1-0.5% stearate. 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). Shanler teaches the use of poloxamer 407 (Shanler at [0136]). Generally, it is prima facie obvious to select a known material (e.g., the poloxamer 407 of Shanler for incorporation into a composition (that of Swartz), based on its recognized suitability for its intended use (a poloxamer in a personal care composition). See MPEP 2144.07.
Regarding instant claim 13d, Swartz teaches the use of polyols including mannitol and sorbitol in an amount ranging between 2% to about 25% by weight of the oral care composition (Swartz at [0108-0119]) which overlaps with the instantly claimed range of about 15%-25%. 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 13e, Shanler teaches a composition comprising 0.01% to 20% preservatives (Shanler at [0141]) and further recites sodium benzoate and potassium sorbate (Shanler at [0130]), which overlaps with the instantly claimed range of 15-25% of sodium benzoate and 1-8% of potassium sorbate. 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 14, Swartz teaches the use of polyvinylpyrrolidone in an amount from about 0.1 to about 50% by weight of the oral care composition (Swartz at [0082-0103]) which overlaps the instantly claimed range of 2% to 6%. 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 15g, Swartz teaches the use of hydroxypropyl cellulose in an amount from 0.1% to 50% by weight of the composition (Swartz at [0082-0103]) which overlaps with the claimed range of 1% to 5%. 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 15h, Swartz teaches the use of multiple buffering agents including 0.5% to 75% of sodium carbonate (Swartz at [0121-0129]) and 0.005% to 10% of citric acid (Swartz at [0182-0186]) which overlaps with the instantly claimed range of 20-30% buffering agents. 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 15, Swartz teaches the use of multiple buffering agents including 0.5% to 75% of sodium bicarbonate (Swartz at [0121-0129]) which overlaps with the instantly claimed 15-20% of carbonate. 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 20, Swartz teaches the inclusion of a magnesium ion source (Swartz at [0136-0140]). Wynn teaches the use of magnesium stearate as a lubricant in the tablet (Wynn at [0055]).
Regarding instant claim 21, Swartz teaches wherein the oral care composition may include one or more surfactants at a level of from about 0.1% to about 15% (Swartz [0151]), which overlaps the instantly claimed range of 0.3 to 3%. Shanler teaches the composition may comprise two or more surfactants where each surfactant may be from about 0.5% to about 5% by weight of the composition (Shanler at [0150]), which overlaps the instantly claimed range of 0.3 to 3%. 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 22 Swartz teaches wherein the oral care composition may include one or more surfactants at a level of from about 0.1% to about 15% (Swartz [0151]), which overlaps the instantly claimed range of 0.5 to 2.5%. Shanler teaches the composition may comprise two or more surfactants where each surfactant may be from about 0.5% to about 5% by weight of the composition (Shanler at [0150]), which overlaps the instantly claimed range of 0.5 to 2.5%. 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).
Response to Arguments
Applicant's arguments filed 10/25/2024 have been fully considered but they are not persuasive.
Applicant argues that the prior art does not show an embodiment with the specific ranges of surfactants disclosed in the instant claims. Applicant argues that the teaching of Swartz is too broad and teaches too many surfactants. As such the obviousness rejection should be withdrawn.
The Examiner does not agree. The use of patents as references is not limited to what the patentees describe as their own inventions or to the problems with which they are concerned. They are part of the literature of the art, relevant for all they contain. See MPEP 2123(I). The prior art does not have to teach a specific embodiment with the exact range and materials for an obviousness rejection. The art is relevant for all it teaches. Including the finite list of surfactants that may be combined to act for the intended purpose as a surfactant in an oral care composition. Swartz teaches wherein the oral care composition may include one or more surfactants at a level of from about 0.1% to about 15% (Swartz [0151]), which overlaps the instantly claimed ranges of 0.1 to 5%, 0.3 to 3%, and 0.5 to 2.5%. Shanler teaches the composition may comprise two or more surfactants where each surfactant may be from about 0.5% to about 5% by weight of the composition (Shanler at [0150]), which overlaps the instantly claimed ranges of 0.1 to 5%, 0.3 to 3%, and 0.5 to 2.5%. 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). As such the Applicant’s arguments are not persuasive and the obviousness rejection is maintained.
Relevant Prior Art
Cutler et. al. (U.S. Patent 8,6581,39 B1)
Cutler recites dental products to prevent and treat dentinal hypersensitivity, prevent tooth decay and heal incipient caries, prevent formation of oral plaque and tartar, prevent and treat aphthous ulcers, oral mucositis, periodontal disease, perioral dermatitis, halitosis, oral candida, and chapped lips, and ameliorate the condition of those suffering from xerostomia and cold sores, comprising: 0.25 to 40 weight percent of nanocalcite particles having a particle size of 1 to 1000 nm; 8 to 95% by weight of xylitol; a surfactant system employing poloxamer as the main surfactant, wherein said poloxamer, or a mixture of poloxamers, comprise 0.01 to 10 weight % of said dental product, said system further comprising anionic polysaccharide (AP), or a mixture of APs, plus a nonionic cellulose ether (NCE), or a mixture of NCEs, in a ternary surfactant system having enhanced foaming power relative to poloxamers alone or to poloxamers plus APs or to poloxamers plus NCEs, wherein the weight ratio of said poloxamer to said APs is greater than 1, and the weight ratio of said AP to said NCE is greater than 1 (Cutler at claim 1). Cutler further recites wherein the dental product comprises one or more optional ingredients:
(a) 5 to 90% by weight of polyol humectants selected from the group consisting of glycerol, erythritol, sorbitol, mannitol, maltitol, and polyethylene glycol;
(b) 0.001 to 5% by weight of sweeteners selected from the group consisting of acesulfame and its salts, aspartame, dihydrochalcones, glycyrrhizin and its derivatives, raw and extracted licorice, saccharin, stevia and the rebaudosides, sucralose, talin and the thaumatins;
(c) 1 to 60% by weight of a mild abrasive, having a hardness less than or equal to that of tooth enamel, selected from the group consisting of calcium carbonate, dibasic calcium phosphate, tribasic calcium phosphate, calcium pyrophosphate, and hydroxyapatite;
(d) 1 to 60% by weight of a strong abrasive, having a hardness greater than that of tooth enamel, selected from the group consisting of alumina, silica, titania, and fluoroapatite;
(e) 0.1 to 10% by weight of flavor;
(f) 1 to 5000 ppm by weight of a fluoride containing compound selected from the group consisting of sodium fluoride and sodium monofluorophosphate;
(g) 0.1 to 10% by weight of a mono-, di-, or polydentate acid or its salts selected from the group consisting of citric acid, ethylenediaminetetraacetic acid, ascorbic acid, phosphoric acid, hydrochloric acid, and sulfuric acid to adjust and maintain the pH between 6 and 10;
(h) 0.1 to 1.0% by weight of preservative selected from the group consisting of paraben, potassium sorbate, lactoferrin, lysozyme, and calcium propionate;
(i) 0.1 to 1.0% by weight of antioxidant selected from the group consisting of ascorbic acid, α-tocopherol, β-carotene, coenzyme Q10 and melatonin;
(j) 5 to 95% by weight of water; or
(k) 0.1 to 10% of a thickener selected from the group consisting of colloidal cellulose, hydrated silica, polyethylene glycol, and polyvinylpyrrolidone (Cutler at claim 5). Cutler further recites that the dental product can be in the form of a dentifrice powder, said dental product further comprising one or more optional ingredients, including an abrasive, and a mild flavor; if desired, the powder can be granulated by the usual methods; if further desired, the granules can be blended with 0.1 to 0.5% by weight of a tablet lubricant selected from the group consisting of calcium stearate, magnesium stearate, hydrogenated vegetable oil, and beeswax; the granules can be compressed into a tablet which disintegrates in the mouth and can then be chewed into a paste (Cutler at claim 10).
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 Cutler et al (US Patent 8,6581,39 B1) appears to be just as good as Swartz et al. (U.S. Patent Application Publication 20190343735 A1). As such, no rejection over Cutler et al (US Patent 8,6581,39 B1) has been written in view of the provisions of MPEP 904.03.
Kilpatrick-Liverman (U.S. 2018/0318200 A1)
Kilpatrick-Liverman teaches a mouthwash comprising partially hydrolyzed plant protein, which is useful, e.g. in methods of repairing or inhibiting dental erosion, promoting dental remineralization, and/or enhancing the anti-cavity effects of fluoride (Kilpatrick-Liverman at abstract). Kilpatrick-Liverman teaches a composition comprising a nonionic surfactant, for example (i) a copolymer of propylene glycol and ethylene glycol, for example a triblock copolymer consisting of a central hydrophobic block of polypropylene glycol flanked by two hydrophilic blocks of polyethylene glycol, e.g. a poloxamer, e.g., poloxamer 188, poloxamer 338, poloxamer 407, or mixtures thereof, e.g. in an amount of 0.1-2% by weight, e.g. about 0.5%, and/or (ii) a polysorbate, for example, polysorbate 20, e.g. in an amount of 0.1-1% by weight, e.g. about 0.5%, and/or (iii) a polyethoxylated vegetable oil, e.g. polyoxyl 40 hydrogenated castor oil, e.g. in an amount of 0.05-0.5% by weight, e.g. about 0.1% (Kilpatrick-Liverman at 1A.13) . Kilpatrick-Liverman an oral care composition of the invention comprises a preservative. The preservative may be selected from parabens, potassium sorbate, benzyl alcohol, phenoxyethanol, polyaminopropryl biguanide, caprylic acid, sodium benzoate and cetylpyridinium chloride. In some embodiments, the preservative is present at a concentration of from about 0.001 to about 1 weight %, by total weight of the composition (Kilpatrick-Liverman at [0153]). Kilpatrick-Liverman teaches that the composition comprises an anionic surfactant, for example sodium lauryl sulfate or sodium lauryl ether sulfate or mixtures thereof, e.g. in an amount of 0.01-0.5%, e.g. about 0.05% by weight (Kilpatrick-Liverman at 1A.12).
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 Kilpatrick-Liverman appears to be just as good as Swartz et al. As such, no rejection over Kilpatrick-Liverman has been written in view of the provisions of MPEP 904.03.
Conclusion
No claims are presently allowable.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the date of this final action.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMANDA MICHELLE PETRITSCH at (571)272-6812. The examiner can normally be reached M-F 08:30-17:00 EST ALT Fridays.
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/AMANDA MICHELLE PETRITSCH/Examiner, Art Unit 1612
/WALTER E WEBB/Primary Examiner, Art Unit 1612
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