DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 17 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 17 depends from claim 1. Claim 1 requires “a free water content of greater than about 10%, by weight”. Claim 17 requires “free water is present in an amount from about 10 to 20%, by weight”. Since the term “about” is inclusive of amounts above and below the recited value, claim 17 reads on amounts less than 10%, while claim 1 requires greater than about 10%. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
1) Claims 1-15, 17-19 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Bilali (US 6,169,118, cited in IDS) in view of Gaffar et al. (US 5,135,738).
Bilali teaches compositions for masking the unpleasant taste or aftertaste of zinc (Abstract), wherein the composition forms include “paste and gel forms such as dentifrices; liquids such as syrups, mouthwashes, and sprays” (col. 4, lines 62-66). As a dentifrice it would have been obvious to contact the oral cavity surface of a patent, as per claim 15.
The compositions comprise water soluble fluoride such as sodium fluoride (col. 4, lines 48-51; clms. 11, 12), and polyphosphates and pyrophosphates generally as antitartar agents (col. 2, lines 38-42). Accordingly, it would have been obvious to add tetrasodium pyrophosphate, as per claim 13. Water usually comprises up to about 50% of the composition (col. 3, lines 62-64), as per claims 1, 14, 17. Sweeteners may also be added such as “saccharin”, used a levels of “from about 0.05% to about 2%” (col. 3, lines 58-61), which makes obvious sodium saccharin of claim 19.
The compositions comprise mixtures of ionizable zinc compounds selected from zinc oxide, zinc citrate and zinc hydroxide (see Claim 4 at col. 6). "Zinc citrate is preferred for dental formulations” (col. 2, lines 45-46) for tartar removal/anti-odor. “[D]ental formulations include such materials as zinc oxide for use in inhibiting bacterial attack in dentifrices" (col. 2, lines 33-34). “In general, the concentration of zinc compounds in orally administered formulations varies from 0.1 to 15%", preferably "from about 0.2 to 2 wt.%" (col. 2, lines 49-55).
Generally, in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists (MPEP 2144.05).
Accordingly, it would have been obvious to a person having ordinary skill in the art at the time of applicant's invention to combine zinc citrate as a preferred zinc salt (first metal salt) and zinc oxide (second metal salt) for inhibiting bacterial attack in a dentifrice, where the concentration of zinc citrate fall within about 2%, and the zinc oxide falls within about 0.25 or 0.5%, since the amount of zinc in Bilali is from about 0.1 to 15 wt %. The combination is sufficient to provide a synergistic increase in delivery of metal ion of the first or second metal salt.
Bilali does not teach polymethyl ether/maleic anhydride copolymer.
Gaffar et al. teaches oral care compositions for treating or inhibiting development of plaque on teeth (Abstract).
In that effort, Gaffar et al. teaches, “Additionally, it may be desirable to employ a polycarboxylate, such as polyvinyl methyl ether anhydride (PVM/MA) copolymer (Gantrez®) in an amount corresponding to about 0.5 to 4% of the dentifrice”, which “has been found substantially to improve the anti-plaque action of the antibacterial compound” (col. 7, lines 55-59).
“The selection of a known material based on its suitability for its intended use supported a prima facie obviousness determination in Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945)” (see MPEP 2144.07).
It would have been obvious to a person having ordinary skill in the art at the time of applicant’s invention to add polyvinyl methyl ether anhydride copolymer to the compositions of Bilali based on its suitability for its intended use in treating the oral cavity, including dental plaque, as taught by Gaffar et al.
2) Claims 1-15, 17-19 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Pader (US 4,100,269, cited in IDS) in view of Bilali (US 6,169,118, cited in IDS) and further in view of Gaffar et al. (US 5,135,738).
The compositions of Pader comprise insoluble zinc compounds "having a solubility of less than about one gm of zinc per 100 cc of water at 20C" (col. 3, lines 12-14). Suitable zinc compounds include zinc tribromosalicylanilide, zinc citrate, zinc oxide, zinc silicate, (col. 3, line 28); the amount of zinc salt ranges from 1/10% to about 25% (Abstract); an abrasive (col. 2, lines 33-35).
Pader et al. teaches a mouthwash formulation comprising 5% zinc citrate (first metal salt/ tartar control agent) and 0.125% zinc tribromosalicylanilide (second metal salt), and free water greater than about 10 and 15% by weight (see Example 1 at col. 5 below, as per claims 1, 14:
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Since Zinc tribromosalicylanilide is described as a having a solubility “not more than about 0.5 gm of zinc per 100cc of water at 20°C” along with zinc oxide, it is shown to be a suitable replacement for zinc oxide and thus reasonably expected to have the same properties. Accordingly, the property of “wherein the second metal salt is present in an amount effective to provide a synergistic increase in delivery of the metal ion of the first or second metal salt”, would have been inherent.
As a mouthwash, it would have been obvious to contact the oral cavity surface of a patient, as per claim 15.
Pader does not require zinc oxide or zinc silicate as the second metal salt.
Generally, it is obvious to replace one component for another equivalent component if it is recognized in the art that two components are equivalent and is not based on the Applicant’s disclosure (see MPEP 2144.06).
Accordingly, it would have been obvious to replace the zinc tribromosalicylanilide with zinc oxide based on the art recognized equivalence.
Since the formulations are taught to comprise “formulations being generally prepared in accordance with the art-recognized practice” (col. 2, lines 15-16), it would have been obvious for the compositions to also comprise common dentifrice components such as fluoride.
Pader does not teach sodium fluoride and tetrasodium pyrophosphate.
Bilali, also taught above, teaches use of polyphosphates for tartar removal (col. 2, lines 39-42) and sodium fluoride as additional therapeutic material (col. 4, lines 48-51).
Bilali also provides further motivation for adding zinc oxide, in particular, to the zinc citrate compositions of Pader, i.e., “dental formulations include such materials as zinc oxide for use in inhibiting bacterial attack in dentifrices” (col. 2, lines 33-34 of Bilali).
It would have been obvious to a person having ordinary skill in the art at the time of applicant’s invention to add sodium fluoride and tetrasodium pyrophosphate to the compositions of Pader, since these are typical ingredients found in dental formulation, as taught by Bilali.
Generally, it is prima facie obvious to select a known material based on its suitability for its intended use (see MPEP 2144.07). Also, established precedent holds that it is generally obvious to add known ingredients to known compositions with the expectation of obtaining their known function (see 2144.06).
Further, the sodium fluoride would have been expected to provide additional therapeutic benefit, i.e. treatment of dental caries and tetrasodium pyrophosphate would have provided additional anti-tartar protection.
The combination of Pader and Bilali does not teach polymethyl ether/maleic anhydride copolymer.
Gaffar et al. teaches oral care compositions for treating or inhibiting development of plaque on teeth (Abstract). Suitable compositions include “paste or gel dentifrice or a liquid mouthwash” (Abstract).
In that effort to treat the oral cavity, Gaffar et al. teaches, “Additionally, it may be desirable to employ a polycarboxylate, such as polyvinyl methyl ether anhydride (PVM/MA) copolymer (Gantrez®) in an amount corresponding to about 0.5 to 4% of the dentifrice”, which “has been found substantially to improve the anti-plaque action of the antibacterial compound” (col. 7, lines 55-59).
The compositions of Gaffar also comprise “Sodium saccharin” at 0.02% (col. 12, Example 2), as per claims 18-19.
“The selection of a known material based on its suitability for its intended use supported a prima facie obviousness determination in Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945)” (see MPEP 2144.07).
It would have been obvious to a person having ordinary skill in the art at the time of applicant’s invention to add polyvinyl methyl ether anhydride copolymer and sodium saccharin to the compositions of Pader based on its suitability for its intended use in oral care formulations for treating the oral cavity, including dental plaque, as taught by Gaffar et al.
3) Claims 1-15, 17-21 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Roberts (US 3,622,662, cited in IDS) in view of Piechota (US 5,256,396, cited in IDS) and further in view of Gaffar et al. (US 5,135,738).
Roberts teaches a dental cream comprising 17% water, 0.6% zinc sulfate (first metal salt), 1.0% zinc oxide (second metal salt) sodium benzoate (antibacterial agent), 0.2% sodium saccharin (sweetener) (Example 1A at col. 4). As a dentifrice, it would have been obvious to contact the oral cavity surface of a patent, as per claim 15.
Zinc oxide can be from 0.15-2% (col. 1, lines 66-71) and the zinc sulfate can be from 0.25-3% (col. 2, lines 5-8), as per claims 6-10. Compositions further comprise a fluoride ion source, e.g. “sodium fluoride” (col. 3, lines 60-71) as per claims 11-12; tetrasodium pyrophosphate (col. 1, line 74) as per claim 13, “sodium saccharine” (col. and “stannous fluoride” (col. 3, lines 64-65), as per claims 20-21.
Accordingly, the prior art has "a synergystic increase in delivery of the metal ion of the first or second metal salt” insofar as it teaches a zinc sulfate as the first metal salt, and zinc oxide as the second metal salt, and free water greater than about 10%.
Roberts does not teach where the astringent is zinc citrate.
Piechota teaches, “Such active ingredients may also include astringent salts . . . . Examples of astringent compounds utilized in orally applied compositions include zinc salts such as zinc chloride and zinc citrate which are soluble in water” (col. 4, lines 55-63).
Generally, it is prima facie obvious to select a known material based on its suitability for its intended use (see MPEP 2144.07). Also, established precedent holds that it is generally obvious to add known ingredients to known compositions with the expectation of obtaining their known function (see 2144.06).
It would have been obvious to a person having ordinary skill in the art at the time of applicant’s invention to replace the zinc sulfate of Roberts with the zinc citrate of Piechota et al. since they are recognized as equivalent in regard to providing astringency to orally applied compositions.
The combination of Roberts and Piechota does not teach polymethyl ether/maleic anhydride copolymer.
Gaffar et al. teaches oral care compositions for treating or inhibiting development of plaque on teeth (Abstract).
In that effort, Gaffar et al. teaches, “Additionally, it may be desirable to employ a polycarboxylate, such as polyvinyl methyl ether anhydride (PVM/MA) copolymer (Gantrez®) in an amount corresponding to about 0.5 to 4% of the dentifrice”, which “has been found substantially to improve the anti-plaque action of the antibacterial compound” (col. 7, lines 55-59).
“The selection of a known material based on its suitability for its intended use supported a prima facie obviousness determination in Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945)” (see MPEP 2144.07).
It would have been obvious to a person having ordinary skill in the art at the time of applicant’s invention to add polyvinyl methyl ether anhydride copolymer to the compositions of Roberts based on its suitability for its intended use in oral care formulations for treating the oral cavity, including dental plaque, as taught by Gaffar et al.
4) Claims 1-15, 17-21 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Modak et al., (US 2012/0201902, cited in IDS) in view of Roberts (US 3,622,662, cited in IDS) and further in view of Gaffar et al. (US 5,135,738).
Modak et al. teaches antimicrobial/preservative compositions comprising “[c]ombinations of zinc salts” (p. 7, para. [0089]). “[P]roducts include but are not limited to oral products such as mouth rinse, toothpaste, and dental floss coatings . . .” (p. 8, para. [0099]). As a dentifrice it would have been obvious to contact the oral cavity surface of a patent, as per claim 15.
Modak et al. teaches a specific embodiment of a topical cream comprising 0.2% zinc lactate, 0.3% zinc oxide, and 54.56% water (Table 15B, p. 13). Other sufficient embodiment are taught as well, i.e. Table 34 (p. 18), Table 47 (p. 22), Table 48 (p. 23), Table 49 (Id.), Table 95 (p. 35), Table 134 (p, 43), Table 158 (p. 48), Table 160 (Id.), Table 161 (p. 49), Table 162 (Id.), Table 167, Table 168 (p. 50).
Note: oral care products are topical products.
As a solvent water may be present from about “0% to about 90%” (p. 4, para. [0065] and [0069]).
Since the prior art teaches combining zinc lactate and zinc oxide it inherently possess the claimed synergistic property wherein the second metal salt provides synergistic increase in delivery of the metal ion of the first or second metal salt”. Note that zinc lactate is disclosed by applicant as a suitable first metal salt.
Assuming arguendo, that the prior art embodiments do not suffice as oral care compositions it would have been obvious to formulate oral care compositions since the prior art teaches formulating oral care products. Given the vast number of embodiments having combinations of first and second metal salts, as claimed, it would have been obvious to formulate an oral care composition with this feature. Thus, the synergistic increase in delivery of the metal ion of the first or second metal salt, would have been implicit.
In regard to zinc salt amounts, Modak et al. teaches, “Zinc salts are used in amounts ranging from about 0.2 to about 1% w/w" (p. 7, para. [0089]), as per claims 6-8). Since the term “about” is inclusive of amounts above and below the recited value, there is an overlap with the about 1% of the prior art and the about 2% of claim 1. Where the prior art does not disclose the exact claimed values, even a slight overlap in range establishes a prima facie case of obviousness. In re Peterson, 65 USPQ2d 1379, 1382 (Fed. Cir. 2003).
The prior art teaches a first metal salt, a second metal salt, and a free water content of greater than about 10% by weight, as per claim 1, but is not anticipatory insofar as it does not require zinc citrate, zinc nitrate or zinc glycinate.
Modak teaches zinc citrate as a suitable zinc salt (p. 7, para. [0088]), as per claim 4. Modak also teaches 0.08% sodium saccharin (p. 21, para. [0148], Table 45), as per claims 18-19..
Accordingly, it would have been obvious for the compositions to comprise zinc citrate and zinc oxide.
Modak et al., does not teach the claimed fluoride ion source and tartar control agent.
Roberts, also taught above, teaches oral care compositions comprising a fluoride ion source, e.g. sodium fluoride, stannous fluoride (col. 3, lines 60-71); tetrasodium pyrophosphate (col. 1, line 74), as per claims 11-13, 19-21.
Generally, it is prima facie obvious to select a known material based on its suitability for its intended use (see MPEP 2144.07). Also, established precedent holds that it is generally obvious to add known ingredients to known compositions with the expectation of obtaining their known function (see 2144.06).
It would have been obvious to add the claimed source of fluoride and tartar control agent to the compositions of Modak et al. based on their recognized suitability for use in dental compositions have two sources of zinc ions, as taught by Roberts.
The combination of Modak et al. and Roberts does not teach polymethyl ether/maleic anhydride copolymer.
Gaffar et al. teaches oral care compositions for treating or inhibiting development of plaque on teeth (Abstract).
In that effort, Gaffar et al. teaches, “Additionally, it may be desirable to employ a polycarboxylate, such as polyvinyl methyl ether anhydride (PVM/MA) copolymer (Gantrez®) in an amount corresponding to about 0.5 to 4% of the dentifrice”, which “has been found substantially to improve the anti-plaque action of the antibacterial compound” (col. 7, lines 55-59).
“The selection of a known material based on its suitability for its intended use supported a prima facie obviousness determination in Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945)” (see MPEP 2144.07).
It would have been obvious to a person having ordinary skill in the art at the time of applicant’s invention to add polyvinyl methyl ether anhydride copolymer to the compositions of Modak et al. based on its suitability for its intended use in treating the oral cavity, including dental plaque, as taught by Gaffar et al.
5) Claims 1-15, 17-22 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Modak, (US 2011/0229534, cited in IDS) in view of Roberts (US 3,622,662, cited in IDS) and further in view of Gaffar et al. (US 5,135,738).
Modak teaches a toothpaste comprising 0.3% zinc lactate (first metal salt), 0.2% zinc oxide (second metal salt), 0.2% sodium saccharin, and water qs ~43% (greater than about 10%) (Example 5 at p. 6). This embodiment includes an antimicrobial agent, i.e. tetrahydro-curcuminoid.
The prior art teaches a first metal salt, a second metal salt, and a free water content of greater than about 10% by weight, as per claim 1, but is not anticipatory insofar as it does not require zinc citrate. The prior art salts are not contained in a film.
Since the prior art teaches combining zinc lactate and zinc oxide it inherently possess the claimed synergistic property wherein the second metal salt provides synergistic increase in delivery of the metal ion of the first or second metal salt”. Note that zinc lactate is disclosed by applicant as a suitable first metal salt.
Modak teaches zinc citrate as a suitable zinc salt (p. 2, para. [0018]). In regard zinc compound concentration Modak teaches, “Other zinc salts, including for example zinc hydrochloride may be present in amounts ranging from about 0.1% to about 2.0%” (p. 2, para. [0019]). Here, a prima facie case of obviousness exists insofar as the claimed ranges for zinc salts overlap with the range disclosed by the prior art.
Accordingly, it would have been prima facie obvious to add zinc citrate or replace zinc lactate with zinc citrate in the prior art compositions, as per claim 1.
Modak does not teach a fluoride ion source.
Roberts, also taught above, teaches oral care compositions comprising a fluoride ion source, e.g. sodium fluoride, stannous fluoride (col. 3, lines 60-71); tetrasodium pyrophosphate (col. 1, line 74).
Generally, it is prima facie obvious to select a known material based on its suitability for its intended use (see MPEP 2144.07). Also, established precedent holds that it is generally obvious to add known ingredients to known compositions with the expectation of obtaining their known function (see 2144.06).
It would have been obvious to add the claimed source of fluoride and tartar control agent, i.e. tetrasodium pyrophosphate, and stannous, to the compositions of Modak et al. based on their recognized suitability for use in dental compositions have two sources of zinc ions, as taught by Roberts. It should be noted here that Modak et al. recognized “zinc salicylate and other zinc salts (e.g. zinc gluconate and zinc lactate) along with an inorganic fluoride salt has been used in oral compositions for inhibiting odor causing bacteria and preventing plaque formation” (p. 1, para. [0009]).
The combination of Modak and Roberts does not teach polymethyl ether/maleic anhydride copolymer.
Gaffar et al. teaches oral care compositions for treating or inhibiting development of plaque on teeth (Abstract).
In that effort, Gaffar et al. teaches, “Additionally, it may be desirable to employ a polycarboxylate, such as polyvinyl methyl ether anhydride (PVM/MA) copolymer (Gantrez®) in an amount corresponding to about 0.5 to 4% of the dentifrice”, which “has been found substantially to improve the anti-plaque action of the antibacterial compound” (col. 7, lines 55-59).
“The selection of a known material based on its suitability for its intended use supported a prima facie obviousness determination in Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945)” (see MPEP 2144.07).
It would have been obvious to a person having ordinary skill in the art at the time of applicant’s invention to add polyvinyl methyl ether anhydride copolymer to the compositions of Modak based on its suitability for its intended use in oral care compositions for treating the oral cavity, including dental plaque, as taught by Gaffar et al.
Nonstatutory Obvious-type 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 obviousness-type 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); and 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 a nonstatutory double patenting ground provided the conflicting application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement.
Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b).
Conclusion
1) Claims 1-15, 17-22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of U.S. Patent No. 9,486,396 in view of Gaffar et al. (US 5,135,738). Both applications claim compositions comprising first and second metal salts, e.g. zinc citrate and zinc oxide, and greater than 10% water. The instant claims differ from the ‘396 patent insofar as the instant claims comprise pvme/ma copolymer. This deficiency is made obvious in view of Gaffar et al. teaching, “Additionally, it may be desirable to employ a polycarboxylate, such as polyvinyl methyl ether anhydride (PVM/MA) copolymer (Gantrez®) in an amount corresponding to about 0.5 to 4% of the dentifrice”, which “has been found substantially to improve the anti-plaque action of the antibacterial compound” (col. 7, lines 55-59). It would have been obvious to add pvme/ma copolymer to the compositions of the ‘396 patent motivated by the desire to treat or prevent dental plaque.
2) Claims 1-15, 17-22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of U.S. Patent No. 10,195,124 in view of Gaffar et al. (US 5,135,738). Both applications claim compositions comprising first and second metal salts, e.g. stannous, zinc citrate and zinc oxide, tetrasodium pyrophosphate, and greater than 10% water. The instant claims differ from the ‘124 patent insofar as the instant claims comprise pvme/ma copolymer. This deficiency is made obvious in view of Gaffar et al. teaching, “Additionally, it may be desirable to employ a polycarboxylate, such as polyvinyl methyl ether anhydride (PVM/MA) copolymer (Gantrez®) in an amount corresponding to about 0.5 to 4% of the dentifrice”, which “has been found substantially to improve the anti-plaque action of the antibacterial compound” (col. 7, lines 55-59). It would have been obvious to add pvme/ma copolymer to the compositions of the ‘124 patent motivated by the desire to treat or prevent dental plaque.
3) Claims 1-15, 17-22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of U.S. Patent No. 10,342,750 in view of Gaffar et al. (US 5,135,738). Both applications claim compositions comprising first and second metal salts, e.g. zinc citrate and zinc oxide, fluoride, and greater than 10% water. The instant claims differ from the ‘750 patent insofar as the instant claims comprise pvme/ma copolymer. This deficiency is made obvious in view of Gaffar et al. teaching, “Additionally, it may be desirable to employ a polycarboxylate, such as polyvinyl methyl ether anhydride (PVM/MA) copolymer (Gantrez®) in an amount corresponding to about 0.5 to 4% of the dentifrice”, which “has been found substantially to improve the anti-plaque action of the antibacterial compound” (col. 7, lines 55-59). It would have been obvious to add pvme/ma copolymer to the compositions of the ‘750 patent motivated by the desire to treat or prevent dental plaque.
4) Claims 1-15, 17-22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of U.S. Patent No. 11,278,477 in view of Gaffar et al. (US 5,135,738). Both applications claim compositions comprising first and second metal salts, e.g. zinc citrate and zinc oxide, fluoride and greater than 10% water. The instant claims differ from the ‘477 patent insofar as the instant claims comprise pvme/ma copolymer. This deficiency is made obvious in view of Gaffar et al. teaching, “Additionally, it may be desirable to employ a polycarboxylate, such as polyvinyl methyl ether anhydride (PVM/MA) copolymer (Gantrez®) in an amount corresponding to about 0.5 to 4% of the dentifrice”, which “has been found substantially to improve the anti-plaque action of the antibacterial compound” (col. 7, lines 55-59). It would have been obvious to add pvme/ma copolymer to the compositions of the ‘477 patent motivated by the desire to treat or prevent dental plaque. Gaffar et al. also teaches adding sodium lauryl sulfate (col. 7, line 45), which would have also been obvious to include in the instant claims based on its suitability for its intended use in oral care formulations.
Conclusion
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Any inquiry concerning this communication or earlier communications from the examiner should be directed to WALTER E WEBB whose telephone number is (571)270-3287 and fax number is (571) 270-4287. The examiner can normally be reached from Mon-Fri 7-3:30.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sahana Kaup can be reached (571) 272-6897. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Walter E. Webb
/WALTER E WEBB/Primary Examiner, Art Unit 1612
Prosecution Insights