DETAILED ACTION
Applicants' arguments, filed 11/25/2025, have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections 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 62/891,597 filed 08/26/2019. The instant application is a 371 of PCT/US20/47697 filed 08/24/2020.
Information Disclosure Statement
The information disclosure statement (IDS) dated 10/03/2025 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 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.
A) Claims 1-3, 7-9, 13-14, and 16-17 are rejected under 35 U.S.C. 103 as being unpatentable over Adusumilli et al (US Patent Application Publication 20100298463A1) in view of Prosise (US Patent Application Publication 20130209376 A1, provided in the IDS filed 03/28/2022).
Adusumilli teaches the use of poly(methylvinyl ether-co-maleic acid) and its derivatives, such as Gantrez® acids, Gantrez® salts (for example, sodium, calcium, magnesium, zinc), and Gantrez® anhydride. As used herein, the term “Gantrez® double or triple salts” refers to the copolymer of methylvinyl ether-co-maleic acid neutralized by two or more sodium, calcium, magnesium and/or zinc ions. In one embodiment, the composition comprises 0.5 to 10 wt. % Gantrez® salt polymer (Adusumilli at [0030]). Adusumilli teaches the use of carboxymethyl-cellulose. Adusumilli teaches the use of carboxymethyl-cellulose (Adusumilli at [0028]). Adusumilli further teaches that the composition may contain 8 to 20% hydroxypropyl methyl cellulose (Adusumilli at [0035]). (Adusumilli at [0028]). Adusumilli teaches the use of polyvinylpyrrolidone, copolymers of vinylpyrrolidone and their derivatives, such as Plasdone® and Polyplasdone® or polyvinylalcohol and its derivatives, such as Kollicoat® polymers, or combination thereof. In one embodiment, the composition comprises 5 to 20 wt.% Plasdone® polymer (Adusumilli at [0033]). Adusumilli teaches the use of vehicles including water, glycerin, propylene glycol, or a low molecular weight polyethylene glycol, alone or in combination. In one embodiment of the invention, the denture adhesive vehicle comprises water alone as the vehicle. In one embodiment of the invention, the composition comprises between 20 and 80 wt. % of water alone as the vehicle (Adusumilli at [0026]). Adusumilli teaches that the denture adhesive compositions may be in the form of a powder, a paste, a cream, a gel or a liner (Adusumilli at [0046]). Adusumilli teaches that the amount of sweetener may be about 0.001 to about 5 wt. % of the total denture adhesive composition (Adusumilli at [0041]). Adusumilli teaches the use of flavoring in an amount from about 0.01% to about 5% (Adusumilli at [0039]). Adusumilli teaches the use of therapeutic actives in a range from 0 to 40% of the composition (Adusumilli at [0044-045). Adusumilli teaches that therapeutic agents may be antimicrobial agents such as iodine, sulfonamides, bisbiguanides, triclosan or phenolics; antibiotics such as tetracycline, neomycin, kanamycin, metronidazole, or clindamycin; anti-inflammatory agents such as aspirin, acetaminophen, naproxen and its salts, ibuprofen, ketorolac, flurbiprofen, indomethacin, eugenol, or hydrocortisone; dentinal desensitizing agents such as potassium nitrate, potassium chloride, strontium chloride or sodium fluoride; anesthetic agents such as lidocaine or benzocaine; antifungals; aromatics such as camphor, eucalyptus oil, and aldehyde derivatives such as benzaldehyde; insulin; steroids; and anti-neoplastics. It is recognized that in certain forms of therapy, combinations of these agents in the same delivery system may be useful in order to obtain an optimal effect. Thus, for example, an antimicrobial and an anti-inflammatory agent may be combined in a single delivery system to provide combined effectiveness (Adusumilli at [0044-045).
The teachings of Adusumilli differ from instant claim 1 insofar as they do not specifically teach the use of FLEXITHIX. The teachings of Prosise cure this deficit.
Prosise teaches a denture product (Prosise at [0006]). Prosise teaches the suse of synthetic anionic polymeric polycarboxylates, in the form 1:4 to 4:1 copolymers of maleic anhydride or acid with another polymerizable ethylenically unsaturated monomer, preferably methyl vinyl ether/maleic anhydride having a molecular weight (M.W.) of about 30,000 to about 1,000,000, most preferably about 30,000 to about 800,000. These copolymers are available for example as Gantrez®, e.g. AN 139 (M.W. 500,000), AN 119 (M.W. 250,000) and preferably S-97 Pharmaceutical Grade (M.W. 700,000) available from ISP (Prosise at [0040]). Prosise teaches the use of sodium carboxymethyl cellulose (Prosise at [0028]). Prosise teaches the use of strongly swellable, lightly to moderately crosslinked PVP include, but are not limited to, FLEXITHIX™, ACP-1120, ACP-1179, and ACP-1180, available from International Specialty Products (Wayne, N.J.) (Prosise at [0013]). Prosise teaches wherein a flavor and sweetening agents may each or together comprise from about 0.1% to 5% or more of the preparation (Prosise at [0036]). Prosise teaches wherein a surface-active agent is typically present in amounts of about 0.5-5% by weight, more particularly about 1-2.5% (Prosise at [0034]). Prosise teaches wherein water is typically present in an amount of at least about 3% by weight, generally about 3-35% and a humectant, typically glycerine, xylitol and/or sorbitol, typically total about 6.5-75% or 80% by weight of the oral composition, more typically about 10-75% (Prosise at [0016]).
The teachings of Prosise differ from instant claim 1 insofar as they do not specifically teach the amount of the Gantrez ® or maleic acid or maleic anhydride copolymer that is metal salt. The teachings of Adusumilli cure this deficit.
It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art. See MPEP 2144.06. It would have been prima facie obvious to have combined the polyvinylpyrrolidone of Adusumilli with the FLEXITHIX polyvinylpyrrolidone of Prosise for the reasonable result of a polyvinylpyrrolidone oral care composition.
Regarding instant claim 1, Adusumilli teaches an improved denture adhesive composition (Adusumilli at abstract).
Regarding instant claim 1i, Adusumilli teaches the use of poly(methylvinyl ether-co-maleic acid) and its derivatives, such as Gantrez® acids, Gantrez® salts (for example, sodium, calcium, magnesium, zinc), and Gantrez® anhydride. As used herein, the term “Gantrez® double or triple salts” refers to the copolymer of methylvinyl ether-co-maleic acid neutralized by two or more sodium, calcium, magnesium and/or zinc ions. In one embodiment, the composition comprises 0.5 to 10 wt. % Gantrez® salt polymer (Adusumilli at [0030]), which overlaps the instantly claimed range of about 10 to about 75%. 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 1ii, Adusumilli teaches the use of carboxymethyl-cellulose (Adusumilli at [0028]). Adusumilli further teaches that the composition may contain 8 to 20% hydroxypropyl methyl cellulose (Adusumilli at [0035]), which overlaps the instantly claimed range of about 10 to about 50%. 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 1iii, Prosise teaches the use of strongly swellable, lightly to moderately crosslinked PVP include, but are not limited to, FLEXITHIX™, ACP-1120, ACP-1179, and ACP-1180, available from International Specialty Products (Wayne, N.J.) (Prosise at [0013]). Adusumilli teaches the use of polyvinylpyrrolidone, copolymers of vinylpyrrolidone and their derivatives, such as Plasdone® and Polyplasdone® or polyvinylalcohol and its derivatives, such as Kollicoat® polymers, or combination thereof. In one embodiment, the composition comprises 5 to 20 wt.% Plasdone® polymer (Adusumilli at [0033]), which overlaps the instantly claimed range of about 0.01 to about 10%. 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 1iv, Adusumilli teaches the use of vehicles including water, glycerin, propylene glycol, or a low molecular weight polyethylene glycol, alone or in combination. In one embodiment of the invention, the denture adhesive vehicle comprises water alone as the vehicle. In one embodiment of the invention, the composition comprises between 20 and 80 wt. % of water alone as the vehicle (Adusumilli at [0026]), which overlaps the instantly claimed range of about 30 to about 70%. 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 1v, Adusumilli teaches the use of therapeutic actives in a range from 0 to 40% of the composition (Adusumilli at [0044-045), which overlaps the instantly claimed range of about 0.01% to about 20%. 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). Adusumilli teaches that therapeutic agents may be antimicrobial agents such as iodine, sulfonamides, bisbiguanides, triclosan or phenolics; antibiotics such as tetracycline, neomycin, kanamycin, metronidazole, or clindamycin; anti-inflammatory agents such as aspirin, acetaminophen, naproxen and its salts, ibuprofen, ketorolac, flurbiprofen, indomethacin, eugenol, or hydrocortisone; dentinal desensitizing agents such as potassium nitrate, potassium chloride, strontium chloride or sodium fluoride; anesthetic agents such as lidocaine or benzocaine; antifungals; aromatics such as camphor, eucalyptus oil, and aldehyde derivatives such as benzaldehyde; insulin; steroids; and anti-neoplastics. It is recognized that in certain forms of therapy, combinations of these agents in the same delivery system may be useful in order to obtain an optimal effect. Thus, for example, an antimicrobial and an anti-inflammatory agent may be combined in a single delivery system to provide combined effectiveness (Adusumilli at [0044-045).
Regarding instant claim 2, Adusumilli teaches the use of poly(methylvinyl ether-co-maleic acid) and its derivatives, such as Gantrez® acids, Gantrez® salts (for example, sodium, calcium, magnesium, zinc), and Gantrez® anhydride. As used herein, the term “Gantrez® double or triple salts” refers to the copolymer of methylvinyl ether-co-maleic acid neutralized by two or more sodium, calcium, magnesium and/or zinc ions (Adusumilli at [0030]).
Regarding instant claim 3, Prosise teaches the use of synthetic anionic polymeric polycarboxylates, in the form 1:4 to 4:1 copolymers of maleic anhydride or acid with another polymerizable ethylenically unsaturated monomer, preferably methyl vinyl ether/maleic anhydride having a molecular weight (M.W.) of about 30,000 to about 1,000,000, most preferably about 30,000 to about 800,000. These copolymers are available for example as Gantrez®, e.g. AN 139 (M.W. 500,000), AN 119 (M.W. 250,000) and preferably S-97 Pharmaceutical Grade (M.W. 700,000) available from ISP (Prosise at [0040]), which overlaps with the instantly claimed molecular weight of about 500,000 to 3,000,000. 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 7, Prosise teaches the use of synthetic anionic polymeric polycarboxylates, in the form 1:4 to 4:1 copolymers of maleic anhydride or acid with another polymerizable ethylenically unsaturated monomer, preferably methyl vinyl ether/maleic anhydride having a molecular weight (M.W.) of about 30,000 to about 1,000,000, most preferably about 30,000 to about 800,000. These copolymers are available for example as Gantrez®, e.g. AN 139 (M.W. 500,000), AN 119 (M.W. 250,000) and preferably S-97 Pharmaceutical Grade (M.W. 700,000) available from ISP (Prosise at [0040]), which overlaps with the instantly claimed molecular weight of about 700,000 to 3,000,000. 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 8, Adusumilli teaches the use of carboxymethyl-cellulose (Adusumilli at [0028]). Adusumilli further teaches that the composition may contain 8 to 20% hydroxypropyl methyl cellulose (Adusumilli at [0035])
Regarding instant claim 9, Adusumilli teaches the use of carboxymethyl-cellulose (Adusumilli at [0028]).
Regarding instant claim 13, Adusumilli teaches the use of polyvinylpyrrolidone, copolymers of vinylpyrrolidone and their derivatives, such as Plasdone® and Polyplasdone® or polyvinylalcohol and its derivatives, such as Kollicoat® polymers, or combination thereof.
Regarding instant claim 14, Adusumilli teaches that the amount of sweetener may be about 0.001 to about 5 wt. % of the total denture adhesive composition (Adusumilli at [0041]), which overlaps the instantly claimed range of about 0.001 to about 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 16, Adusumilli teaches the use of vehicles including water, glycerin, propylene glycol, or a low molecular weight polyethylene glycol, alone or in combination (Adusumilli at [0026]).
Regarding instant claim 17, Adusumilli teaches that the denture adhesive compositions may be in the form of a powder, a paste, a cream, a gel or a liner (Adusumilli at [0046]).
B) Claims 4-6 and 18-22 are rejected under 35 U.S.C. 103 as being unpatentable over Adusumilli et al (US Patent Application Publication 20100298463A1) and Prosise (US Patent Application Publication 20130209376 A1, provided in the IDS filed 03/28/2022) as applied to claims 1-3, 7-9, 13-14, and 16-17 above, and in view of Rajaiah (WO 2007/056612 A2).
The teachings of Adusumilli and Prosise are discussed above.
The teachings of Adusumilli and Prosie differ from instant claim 18 in so far as they do not teach the greater range of maleic acid or maleic anhydride copolymers. The teachings of Rajaiah cure this deficit.
Rajaiah teaches that the level of copolymer of maleic acid or anhydride may be from about 15% to about 70% (Rajaiah at page 12). Rajaiah teaches that the article comprises from about 10, 20, 30% to about 40, 50, 60%, in any combination, of plasticizer or carrier, which include hydroxypropyl methyl cellulose and water (Rajaiah at page 14).Rajaiah teaches that the level of the gellant agent, including polyvinyl pyrrolidone derivatives ranges from about 0.01% to about 40% (Rajaiah at page 14). Rajaiah teaches that flavorings may be present at a level of from about 0% to about 40%, in another embodiment from about 0.05 to about 5%, and in another embodiment from about 0.1 to about 2%, by weight of the article (Rajaiah at pages 14-15). Rajaiah teaches that a therapeutic active may be present at a level of from about 0% to about 70%, by weight of the article, and in one embodiment from about 1% to about 20% by weight of the article (Rajaiah at page 15). Rajaiah teaches that the specific viscosity of the starting copolymer acid or copolymer anhydride is from about 1.2 to about 14, when preferably measured in a 1% weight/volume solution in MEK (methyl ethyl ketone) at 25°C (Rajaiah at page 12).
The teachings of Rajaiah differ from the instant invention insofar as they do not specifically teach the use of sweeteners in the denture adhesive. The teachings of Adusumilli and Prosise cure this deficit.
One would have been motivated to increase the amount of the adhesive agent maleic acid and maleic anhydride copolymers for a more adhesive denture adhesive. See MPEP 2144(II).
It would have been obvious to have increased the amount of adhesive agent, Gantrez®, of Adusumilli to 15 to 75% as that amount is a known and effective amount for maleic acid and maleic anhydride copolymers used as adhesive agents in denture adhesive compositions as taught by Rajaiah. See MPEP 2144.05(II). See MPEP 2144.07.
One would have been motivated to have added the sweetener of Adusumilli to the composition of Rajaiah for a better tasting denture adhesive.
Regarding instant claim 1, Adusumilli teaches an improved denture adhesive composition (Adusumilli at abstract).
Regarding instant claim 1i, Adusumilli teaches the use of poly(methylvinyl ether-co-maleic acid) and its derivatives, such as Gantrez® acids, Gantrez® salts (for example, sodium, calcium, magnesium, zinc), and Gantrez® anhydride. As used herein, the term “Gantrez® double or triple salts” refers to the copolymer of methylvinyl ether-co-maleic acid neutralized by two or more sodium, calcium, magnesium and/or zinc ions. In one embodiment, the composition comprises 0.5 to 10 wt. % Gantrez® salt polymer (Adusumilli at [0030]), which overlaps the instantly claimed range of about 10 to about 75%. 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 1ii, Adusumilli teaches the use of carboxymethyl-cellulose (Adusumilli at [0028]). Adusumilli further teaches that the composition may contain 8 to 20% hydroxypropyl methyl cellulose (Adusumilli at [0035]), which overlaps the instantly claimed range of about 10 to about 50%. 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 1iii, Prosise teaches the use of strongly swellable, lightly to moderately crosslinked PVP include, but are not limited to, FLEXITHIX™, ACP-1120, ACP-1179, and ACP-1180, available from International Specialty Products (Wayne, N.J.) (Prosise at [0013]).Adusumilli teaches the use of polyvinylpyrrolidone, copolymers of vinylpyrrolidone and their derivatives, such as Plasdone® and Polyplasdone® or polyvinylalcohol and its derivatives, such as Kollicoat® polymers, or combination thereof. In one embodiment, the composition comprises 5 to 20 wt.% Plasdone® polymer (Adusumilli at [0033]), which overlaps the instantly claimed range of about 0.01 to about 10%. 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 1iv, Adusumilli teaches the use of vehicles including water, glycerin, propylene glycol, or a low molecular weight polyethylene glycol, alone or in combination. In one embodiment of the invention, the denture adhesive vehicle comprises water alone as the vehicle. In one embodiment of the invention, the composition comprises between 20 and 80 wt. % of water alone as the vehicle (Adusumilli at [0026]), which overlaps the instantly claimed range of about 30 to about 70%. 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 1v, Adusumilli teaches the use of therapeutic actives in a range from 0 to 40% of the composition (Adusumilli at [0044-045), which overlaps the instantly claimed range of about 0.01% to about 20%. 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). Adusumilli teaches that therapeutic agents may be antimicrobial agents such as iodine, sulfonamides, bisbiguanides, triclosan or phenolics; antibiotics such as tetracycline, neomycin, kanamycin, metronidazole, or clindamycin; anti-inflammatory agents such as aspirin, acetaminophen, naproxen and its salts, ibuprofen, ketorolac, flurbiprofen, indomethacin, eugenol, or hydrocortisone; dentinal desensitizing agents such as potassium nitrate, potassium chloride, strontium chloride or sodium fluoride; anesthetic agents such as lidocaine or benzocaine; antifungals; aromatics such as camphor, eucalyptus oil, and aldehyde derivatives such as benzaldehyde; insulin; steroids; and anti-neoplastics. It is recognized that in certain forms of therapy, combinations of these agents in the same delivery system may be useful in order to obtain an optimal effect. Thus, for example, an antimicrobial and an anti-inflammatory agent may be combined in a single delivery system to provide combined effectiveness (Adusumilli at [0044-045).
Regarding instant claim 2, Adusumilli teaches the use of poly(methylvinyl ether-co-maleic acid) and its derivatives, such as Gantrez® acids, Gantrez® salts (for example, sodium, calcium, magnesium, zinc), and Gantrez® anhydride. As used herein, the term “Gantrez® double or triple salts” refers to the copolymer of methylvinyl ether-co-maleic acid neutralized by two or more sodium, calcium, magnesium and/or zinc ions (Adusumilli at [0030]).
Regarding instant claim 3, Prosise teaches the use of synthetic anionic polymeric polycarboxylates, in the form 1:4 to 4:1 copolymers of maleic anhydride or acid with another polymerizable ethylenically unsaturated monomer, preferably methyl vinyl ether/maleic anhydride having a molecular weight (M.W.) of about 30,000 to about 1,000,000, most preferably about 30,000 to about 800,000. These copolymers are available for example as Gantrez®, e.g. AN 139 (M.W. 500,000), AN 119 (M.W. 250,000) and preferably S-97 Pharmaceutical Grade (M.W. 700,000) available from ISP (Prosise at [0040]), which overlaps with the instantly claimed molecular weight of about 500,000 to 3,000,000. 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 4, Rajaiah teaches that the maleic acid copolymers has a cationic salt function comprising from about 5% to about 50% (Rajaiah at pages 9-12) , which overlaps with the instantly claimed range of about 50 to about 100%. 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). Prosise teaches the use of synthetic anionic polymeric polycarboxylates, in the form 1:4 to 4:1 copolymers of maleic anhydride or acid with another polymerizable ethylenically unsaturated monomer, preferably methyl vinyl ether/maleic anhydride having a molecular weight (M.W.) of about 30,000 to about 1,000,000, most preferably about 30,000 to about 800,000. These copolymers are available for example as Gantrez®, e.g. AN 139 (M.W. 500,000), AN 119 (M.W. 250,000) and preferably S-97 Pharmaceutical Grade (M.W. 700,000) available from ISP (Prosise at [0040]), which overlaps with the instantly claimed molecular weight of 50,000 about 500,000. 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 5, Rajaiah teaches that the specific viscosity of the starting copolymer acid or copolymer anhydride is from about 1.2 to about 14, when preferably measured in a 1% weight/volume solution in MEK (methyl ethyl ketone) at 25°C (Rajaiah at page 12) which overlaps the instantly claimed range of 2.5 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 6, Rajaiah teaches that the level of copolymer of maleic acid or anhydride may be from about 15% to about 70% (Rajaiah at page 12), which overlaps the instantly claimed range of about 18 to about 66%. 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 7, Prosise teaches the use of synthetic anionic polymeric polycarboxylates, in the form 1:4 to 4:1 copolymers of maleic anhydride or acid with another polymerizable ethylenically unsaturated monomer, preferably methyl vinyl ether/maleic anhydride having a molecular weight (M.W.) of about 30,000 to about 1,000,000, most preferably about 30,000 to about 800,000. These copolymers are available for example as Gantrez®, e.g. AN 139 (M.W. 500,000), AN 119 (M.W. 250,000) and preferably S-97 Pharmaceutical Grade (M.W. 700,000) available from ISP (Prosise at [0040]), which overlaps with the instantly claimed molecular weight of about 700,000 to 3,000,000. 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 8, Adusumilli teaches the use of carboxymethyl-cellulose (Adusumilli at [0028]). Adusumilli further teaches that the composition may contain 8 to 20% hydroxypropyl methyl cellulose (Adusumilli at [0035]).
Regarding instant claim 9, Adusumilli teaches the use of carboxymethyl-cellulose (Adusumilli at [0028]). Rajaiah teaches the use of sodium carboxymethyl cellulose (Rajaiah at claim 6).
Regarding instant claim 13, Adusumilli teaches the use of polyvinylpyrrolidone, copolymers of vinylpyrrolidone and their derivatives, such as Plasdone® and Polyplasdone® or polyvinylalcohol and its derivatives, such as Kollicoat® polymers, or combination thereof.
Regarding instant claim 14, Adusumilli teaches that the amount of sweetener may be about 0.001 to about 5 wt. % of the total denture adhesive composition (Adusumilli at [0041]), which overlaps the instantly claimed range of about 0.001 to about 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 16, Adusumilli teaches the use of vehicles including water, glycerin, propylene glycol, or a low molecular weight polyethylene glycol, alone or in combination (Adusumilli at [0026]).
Regarding instant claim 17, Adusumilli teaches that the denture adhesive compositions may be in the form of a powder, a paste, a cream, a gel or a liner (Adusumilli at [0046]).
Regarding instant claim 18, Adusumilli teaches an improved denture adhesive composition (Adusumilli at abstract).
Regarding instant claim 18i, Adusumilli teaches the use of poly(methylvinyl ether-co-maleic acid) and its derivatives, such as Gantrez® acids, Gantrez® salts (for example, sodium, calcium, magnesium, zinc), and Gantrez® anhydride. As used herein, the term “Gantrez® double or triple salts” refers to the copolymer of methylvinyl ether-co-maleic acid neutralized by two or more sodium, calcium, magnesium and/or zinc ions. In one embodiment, the composition comprises 0.5 to 10 wt. % Gantrez® salt polymer (Adusumilli at [0030]). Rajaiah teaches that the level of copolymer of maleic acid or anhydride may be from about 15% to about 70% (Rajaiah at page 12), which overlaps the instantly claimed range of about 15 to about 70%. 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 18ii, Adusumilli teaches the use of carboxymethyl-cellulose (Adusumilli at [0028]). Adusumilli teaches the use of carboxymethyl-cellulose (Adusumilli at [0028]). Adusumilli further teaches that the composition may contain 8 to 20% hydroxypropyl methyl cellulose (Adusumilli at [0035]), which overlaps the instantly claimed range of about 10 to about 50%. 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 18iii, Prosise teaches the use of strongly swellable, lightly to moderately crosslinked PVP include, but are not limited to, FLEXITHIX™, ACP-1120, ACP-1179, and ACP-1180, available from International Specialty Products (Wayne, N.J.) (Prosise at [0013]). Adusumilli teaches the use of polyvinylpyrrolidone, copolymers of vinylpyrrolidone and their derivatives, such as Plasdone® and Polyplasdone® or polyvinylalcohol and its derivatives, such as Kollicoat® polymers, or combination thereof. In one embodiment, the composition comprises 5 to 20 wt.% Plasdone® polymer (Adusumilli at [0033]), which overlaps the instantly claimed range of about 0.01 to about 10%. 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 18iv, Adusumilli teaches the use of vehicles including water, glycerin, propylene glycol, or a low molecular weight polyethylene glycol, alone or in combination. In one embodiment of the invention, the denture adhesive vehicle comprises water alone as the vehicle. In one embodiment of the invention, the composition comprises between 10 and 60 wt. % of water alone as the vehicle (Adusumilli at [0026]), which overlaps the instantly claimed range of about 30 to about 70%. 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 18v, Adusumilli teaches the use of therapeutic actives in a range from 0 to 40% of the composition (Adusumilli at [0044-045), which overlaps the instantly claimed range of about 0.01% to about 20%. 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). Adusumilli teaches that therapeutic agents may be antimicrobial agents such as iodine, sulfonamides, bisbiguanides, triclosan or phenolics; antibiotics such as tetracycline, neomycin, kanamycin, metronidazole, or clindamycin; anti-inflammatory agents such as aspirin, acetaminophen, naproxen and its salts, ibuprofen, ketorolac, flurbiprofen, indomethacin, eugenol, or hydrocortisone; dentinal desensitizing agents such as potassium nitrate, potassium chloride, strontium chloride or sodium fluoride; anesthetic agents such as lidocaine or benzocaine; antifungals; aromatics such as camphor, eucalyptus oil, and aldehyde derivatives such as benzaldehyde; insulin; steroids; and anti-neoplastics. It is recognized that in certain forms of therapy, combinations of these agents in the same delivery system may be useful in order to obtain an optimal effect. Thus, for example, an antimicrobial and an anti-inflammatory agent may be combined in a single delivery system to provide combined effectiveness (Adusumilli at [0044-045).
Regarding instant claim 19, Adusumilli teaches an improved denture adhesive composition (Adusumilli at abstract).
Regarding instant claim 19i, Adusumilli teaches the use of poly(methylvinyl ether-co-maleic acid) and its derivatives, such as Gantrez® acids, Gantrez® salts (for example, sodium, calcium, magnesium, zinc), and Gantrez® anhydride. As used herein, the term “Gantrez® double or triple salts” refers to the copolymer of methylvinyl ether-co-maleic acid neutralized by two or more sodium, calcium, magnesium and/or zinc ions. In one embodiment, the composition comprises 0.5 to 10 wt. % Gantrez® salt polymer (Adusumilli at [0030]). Rajaiah teaches that the level of copolymer of maleic acid or anhydride may be from about 15% to about 70% (Rajaiah at page 12), which overlaps the instantly claimed range of about 15 to about 70%. 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 19ii, Adusumilli teaches the use of carboxymethyl-cellulose (Adusumilli at [0028]). Adusumilli teaches the use of carboxymethyl-cellulose (Adusumilli at [0028]). Adusumilli further teaches that the composition may contain 8 to 20% hydroxypropyl methyl cellulose (Adusumilli at [0035]), which overlaps the instantly claimed range of about 10 to about 50%. 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 19iii, Prosise teaches the use of strongly swellable, lightly to moderately crosslinked PVP include, but are not limited to, FLEXITHIX™, ACP-1120, ACP-1179, and ACP-1180, available from International Specialty Products (Wayne, N.J.) (Prosise at [0013]). Adusumilli teaches the use of polyvinylpyrrolidone, copolymers of vinylpyrrolidone and their derivatives, such as Plasdone® and Polyplasdone® or polyvinylalcohol and its derivatives, such as Kollicoat® polymers, or combination thereof. In one embodiment, the composition comprises 5 to 20 wt.% Plasdone® polymer (Adusumilli at [0033]), which overlaps the instantly claimed range of about 0.01 to about 10%. 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 19iv, Adusumilli teaches the use of vehicles including water, glycerin, propylene glycol, or a low molecular weight polyethylene glycol, alone or in combination. In one embodiment of the invention, the denture adhesive vehicle comprises water alone as the vehicle. In one embodiment of the invention, the composition comprises between 20 and 80 wt. % of water alone as the vehicle (Adusumilli at [0026]), which overlaps the instantly claimed range of about 10 to about 60%. 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 19v, Adusumilli teaches the use of therapeutic actives in a range from 0 to 40% of the composition (Adusumilli at [0044-045), which overlaps the instantly claimed range of about 0.01% to about 20%. 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). Adusumilli teaches that therapeutic agents may be antimicrobial agents such as iodine, sulfonamides, bisbiguanides, triclosan or phenolics; antibiotics such as tetracycline, neomycin, kanamycin, metronidazole, or clindamycin; anti-inflammatory agents such as aspirin, acetaminophen, naproxen and its salts, ibuprofen, ketorolac, flurbiprofen, indomethacin, eugenol, or hydrocortisone; dentinal desensitizing agents such as potassium nitrate, potassium chloride, strontium chloride or sodium fluoride; anesthetic agents such as lidocaine or benzocaine; antifungals; aromatics such as camphor, eucalyptus oil, and aldehyde derivatives such as benzaldehyde; insulin; steroids; and anti-neoplastics. It is recognized that in certain forms of therapy, combinations of these agents in the same delivery system may be useful in order to obtain an optimal effect. Thus, for example, an antimicrobial and an anti-inflammatory agent may be combined in a single delivery system to provide combined effectiveness (Adusumilli at [0044-045).
Regarding instant claim 20, Adusumilli teaches that adherent creams, liquids, powders, and “liners” are often used to secure dentures within the mouth. Liners are denture adhesives in the form of a thin film, strip, or wafer with a certain desirable strength and integrity for the liner to be placed in between the prosthesis and the palate or jaw, which swells in the mouth fluid and provides the adhesive effect (Adusumilli at [0002]).
Regarding instant claim 21, Adusumilli teaches an improved denture adhesive composition (Adusumilli at abstract). Adusumilli teaches a better adhesive grip with less oozing, mouth moisturizing/lubricating properties, better mouth feel, improved sensate attributes and a better taste profile to denture wears (Adusumilli at [0010]).
Regarding instant claim 22, Adusumilli teaches an improved denture adhesive composition (Adusumilli at abstract). Adusumilli teaches that adherent creams, liquids, powders, and “liners” are often used to secure dentures within the mouth. Liners are denture adhesives in the form of a thin film, strip, or wafer with a certain desirable strength and integrity for the liner to be placed in between the prosthesis and the palate or jaw, which swells in the mouth fluid and provides the adhesive effect (Adusumilli at [0002]).
Regarding instant claim 22i, Adusumilli teaches the use of poly(methylvinyl ether-co-maleic acid) and its derivatives, such as Gantrez® acids, Gantrez® salts (for example, sodium, calcium, magnesium, zinc), and Gantrez® anhydride. As used herein, the term “Gantrez® double or triple salts” refers to the copolymer of methylvinyl ether-co-maleic acid neutralized by two or more sodium, calcium, magnesium and/or zinc ions. In one embodiment, the composition comprises 0.5 to 10 wt. % Gantrez® salt polymer (Adusumilli at [0030]). Rajaiah teaches that the level of copolymer of maleic acid or anhydride may be from aboiut 15% to about 70% (Rajaiah at page 12), which overlaps the instantly claimed range of about 15 to about 70%. 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 22ii, Adusumilli teaches the use of carboxymethyl-cellulose (Adusumilli at [0028]). Adusumilli teaches the use of carboxymethyl-cellulose (Adusumilli at [0028]). Adusumilli further teaches that the composition may contain 8 to 20% hydroxypropyl methyl cellulose (Adusumilli at [0035]), which overlaps the instantly claimed range of about 10 to about 50%. 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 22iii, Prosise teaches the use of strongly swellable, lightly to moderately crosslinked PVP include, but are not limited to, FLEXITHIX™, ACP-1120, ACP-1179, and ACP-1180, available from International Specialty Products (Wayne, N.J.) (Prosise at [0013]). Adusumilli teaches the use of polyvinylpyrrolidone, copolymers of vinylpyrrolidone and their derivatives, such as Plasdone® and Polyplasdone® or polyvinylalcohol and its derivatives, such as Kollicoat® polymers, or combination thereof. In one embodiment, the composition comprises 5 to 20 wt.% Plasdone® polymer (Adusumilli at [0033]), which overlaps the instantly claimed range of about 0.01 to about 20%. 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 22iv, Adusumilli teaches the use of vehicles including water, glycerin, propylene glycol, or a low molecular weight polyethylene glycol, alone or in combination. In one embodiment of the invention, the denture adhesive vehicle comprises water alone as the vehicle. In one embodiment of the invention, the composition comprises between 20 and 80 wt. % of water alone as the vehicle (Adusumilli at [0026]), which overlaps the instantly claimed range of about 10 to about 60%. 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 22v, Adusumilli teaches the use of therapeutic actives in a range from 0 to 40% of the composition (Adusumilli at [0044-045), which overlaps the instantly claimed range of about 0.01% to about 20%. 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). Adusumilli teaches that therapeutic agents may be antimicrobial agents such as iodine, sulfonamides, bisbiguanides, triclosan or phenolics; antibiotics such as tetracycline, neomycin, kanamycin, metronidazole, or clindamycin; anti-inflammatory agents such as aspirin, acetaminophen, naproxen and its salts, ibuprofen, ketorolac, flurbiprofen, indomethacin, eugenol, or hydrocortisone; dentinal desensitizing agents such as potassium nitrate, potassium chloride, strontium chloride or sodium fluoride; anesthetic agents such as lidocaine or benzocaine; antifungals; aromatics such as camphor, eucalyptus oil, and aldehyde derivatives such as benzaldehyde; insulin; steroids; and anti-neoplastics. It is recognized that in certain forms of therapy, combinations of these agents in the same delivery system may be useful in order to obtain an optimal effect. Thus, for example, an antimicrobial and an anti-inflammatory agent may be combined in a single delivery system to provide combined effectiveness (Adusumilli at [0044-045).
C) Claims 10-12 are rejected under 35 U.S.C. 103 as being unpatentable over Adusumilli et al (US Patent Application Publication 20100298463A1), Prosise (US Patent Application Publication 20130209376 A1, provided in the IDS filed 03/28/2022) and Rajaiah (WO 2007/056612 A2) as applied to claims 1-9, 13-14, and 16-22 above, as evidenced by Sodium carboxymethyl cellulose information page (Thermo Fisher Scientific accessed on Scifindern, 2024).
The teachings of Adusumilli, Prosise, and Rajaiah are discussed above.
The teachings of Adusumilli, Prosise, and Rajaiah differ from instant claims 10 and 11 insofar as they do not explicitly state the average molecular weight of sodium carboxymethyl cellulose.
Regarding instant claims 10 and 11, the Sodium Carboxymethyl Cellulose Information Page (Thermo Fisher Scientific) discloses a typical commercially available product having an average molecular weight of 700,000. This falls squarely within the instantly claimed ranges of 500,000 to 1,200,000, and 600,000 to 800,000, respectively. It would have been obvious to have used the known product of the Information Page to impart it’s known thickening function, per the reasoning of MPEP 2144.07.
Regarding instant claim 12, Adusumilli further teaches that the composition may contain 8 to 20% cellulose (Adusumilli at [0035]).
Response to Arguments
Applicant's arguments filed 11/25/2025 have been fully considered but they are not persuasive.
Applicant argues that the rejection does not include all of the limitations of the amended claims. The Applicant amends claim 1 to include the limitation " wherein the polymer has a Brookfield viscosity of at least about 500 to about 50,000 cps in 4% aqueous solution", which is not present in the present rejection. Since claims 2-14, 16, and 17 depend directly or indirectly on amended claim 1 and include all its limitations, the Applicant respectfully submits that these combinations do not fairly teach or suggest all the limitations of these dependent claims. The Applicant amends claims 18, 19, and 22 to include the limitation “wherein the polymer has a Brookfield viscosity of at least about 500 to about 50,000 cps in 4% aqueous solution”, which is not present in the present rejection. Since claim 21 depends directly on amended claim 19 and includes all its limitations, the Applicant respectfully submits that these combinations do not fairly teach or suggest all the limitations of this dependent claim. In view of the foregoing remarks, the Applicants respectfully request that the Examiner reconsider and withdraw the rejection of the claims as unpatentable.
The Examiner does not find the argument persuasive. Paragraph 44 of the instant specification from which the amendment “wherein the polymer has a Brookfield viscosity of at least about 500 to about 50,000 cps in 4% aqueous solution” is supported recites;
[0044] According to one embodiment of the present application, there is employed a strongly swellable, moderately crosslinked PVP (polyvinylpyrrolidone) polymer available under the tradename FlexiThix™ from Ashland LLC obtained directly as a fine powder by precipitation polymerization of vinyl pyrrolidone in the presence of a predetermined amount of a multifunctional crosslinking agent and a free radical initiator in an organic solvent. The crosslinked PVP has a Brookfield viscosity of at least about 500 to about 50,000 cps in 4% aqueous solution. The preferred viscosity ranges of the crosslinked PVP in the present application can be varied from about 500 to about 50,000 cps or from about 800 to about 20,000 cps or from about 1000 to about 10,000 cps. The Brookfield viscosity can be measured at 2.5, 5, 10, 12, 20, 30, or 50 RPM and at 25°C.
. Therefore, based on the instant specification a teaching of the use of FlexiThix would provide for a strongly swellable, moderately crosslinked PVP with a Brookfield viscosity of at least about 500 to about 50,000 cps in 4% aqueous solution. Prosise teaches the use of strongly swellable, lightly to moderately crosslinked PVP include, but are not limited to, FLEXITHIX™, ACP-1120, ACP-1179, and ACP-1180, available from International Specialty Products (Wayne, N.J.) (Prosise at [0013]). Therefore, the rejections of Adusumilli in view of Prosise as well as Adusumilli and Prosise in view of Rajaiah teach the use of FLEXITHIX and subsequently a strongly swellable, moderately crosslinked PVP with a Brookfield viscosity of at least about 500 to about 50,000 cps in 4% aqueous solution. As such, the Applicant’s argument is not persuasive and the rejection stands.
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 mailing date of this final action.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMANDA MICHELLE PETRITSCH whose telephone number is (571)272-6812. The examiner can normally be reached M-F 08:30-17:00 EST ALT Fridays.
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/AMANDA MICHELLE PETRITSCH/Examiner, Art Unit 1612 /SAHANA S KAUP/Supervisory Primary Examiner, Art Unit 1612