DETAILED ACTION
Applicants' arguments, filed 11/13/2025, 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 Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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 63/151,096 filed on 02/19/2021.
Information Disclosure Statement
The information disclosure statements (IDS) dated 02/10/2026 and 11/13/2025 both comply with provisions of 37 CFR 1.97, 1.98 and MPEP §609. Accordingly, they have been placed in the application file and the information therein has been considered as to the merits.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-2, 4-9, 11-24, 26-27, and 34-36 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites the limitation "a ratio of the amphiphilic polymer to the alkyl alcohol" in line 10. There is insufficient antecedent basis for this limitation in the claim. In the amended instant claim the term “amphiphilic polymer” is not used before line 10, therefore there is insufficient antecedent basis for the tern “the amphiphilic polymer”. Claims 2, 4-9, 11-24, 26-27, and 34-36 depend from claim 1 and are therefore also indefinite.
Claim 1 recites the limitation "a ratio of the amphiphilic polymer to the alkyl alcohol" in line 10. There is insufficient antecedent basis for this limitation in the claim. In the amended instant claim the term “alkyl alcohol” is not used before line 10, therefore there is insufficient antecedent basis for the tern “the alkyl alcohol”. Claims 2, 4-9, 11-24, 26-27, and 34-36 depend from claim 1 and are therefore also indefinite.
Claim 26 recites the limitation "the amphiphilic polymer" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim. There is insufficient antecedent basis for the tern “the amphiphilic polymer”.
Claim 27 recites the limitation "the amphiphilic polymer" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim. There is insufficient antecedent basis for the tern “the amphiphilic polymer”.
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, 4-9, 11-24, 26-27, and 34-36 are rejected under 35 U.S.C. 103 as being unpatentable over Deckner et al. (U.S. Patent App. Pub. 2012/0219606) and Schweizer et al (U.S. Patent 3,112,247) in view of Midha et al. (U.S. Patent App. Pub. 2017/281486 A1).
Deckner teaches an oral care composition comprising arginine (Deckner at [0085], [0120]), peroxide (Deckner at [0108-0109]), water (Deckner at [0033]), calcium pyrophosphate (Deckner at [0083], [0091], [0094]), stannous fluoride (Deckner at [0102]), zinc (Deckner at [0190]), stearyl alcohol (Deckner at [0165]), and sodium lauryl sulfate (Deckner at [0171]). Deckner further teaches the use of arginine as an anti-sensitivity agent (Deckner at [0085]) and an antibacterial agent (Deckner at [0120]). Deckner teaches that anionic surfactants such as sodium lauryl sulfate, are preferred and used in a range of about 0.1% to 20% (Deckner at 0171-0172]), which overlaps the instantly claimed range of about 1% to about 10%.
The teachings of Deckner differ from that of the instant application insofar as they do not teach the use of calcium pyrophosphate with a specific gamma to beta ratio.
Schweizer teaches an oral care composition wherein the percent of beta phase calcium pyrophosphate is at least 50% and the remainder of the calcium pyrophosphate is gamma phase calcium pyrophosphate (Schweizer at column 2 lines 27-36). Schweizer teaches that this ratio is beneficial for increasing fluoride compatibility. Schweizer teaches wherein the composition is a dentifrice like a toothpaste and comprises calcium pyrophosphate, stannous fluoride, and water.
Deckner et al. disclose wherein the dentifrice composition comprises calcium pyrophosphate, but does not disclose a ratio between gamma and beta phase within the calcium pyrophosphate. Accordingly, it would have been obvious to one of ordinary skill in the art to have formulated the calcium pyrophosphate of Deckner et al. to have a ratio of about 1 since that ratio is a known and effective ratio for gamma to beta calcium pyrophosphate used in dentifrice compositions for the benefit of improved fluoride capacity as taught by Schweizer.
The combined teachings of Deckner and Schweizer differ from instant claim 18 and 19 insofar as they do not specifically disclose a specific Brookfields unit viscosity value. The teachings of Midha cure this deficit.
Midha recites an oral care composition comprising a peroxide (Midha at claim 1), AMPS polymer which is an amphiphilic polymer (Midha at claim 4), cetyl alcohol which is an alkyl alcohol (Midha at claim 7), and water (Midha at claim 9). Midha further recites wherein the water is present at 25% to 70% of the composition (Midha at claim 9). Midha further recites wherein the composition has a viscosity of from about 10 BKUs to about 45 BKUs, aka Brookfield Units (Midha at claim 8). Midha recites wherein the composition comprises from about 0.1% to about 8% peroxide (Midha at claim 2). Midha recites an oral care composition comprising sodium monofluorophosphate (Midha at claim 1), calcium pyrophosphate (Midha at claim 3), stannous fluoride (Midha at claim 1), zinc lactate (Midha at [0068]). Midha teaches the use of AMPS (Midha at [0046-0047]) polyacrylates cross polymer-6 or Sepimax Zen in a range of about 0.1% to about 10%
Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use. See MPEP 2144.07. Deckner et al. disclose wherein the oral care composition comprises calcium pyrophosphate, but does not disclose a target viscosity. Accordingly, it would have been obvious to one of ordinary skill in the art to have formulated the calcium pyrophosphate of Deckner et al. to have a viscosity of from about 10 BKUs to about 45 BKUs, aka Brookfield Units since that viscosity is a known and effective for oral care compositions using calcium pyrophosphate as taught by Midha.
Regarding instant claim 1, Deckner teaches the use of peroxide (Deckner at [0108]). Deckner teaches the use of form about 0.5% to about 10% of peroxide (Deckner at [0108]) which overlaps with the instantly claimed range of about 1% 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). Deckner teaches the use of AMPS (Deckner at [0105]) in a range of 0.1% to 15%, which overlaps the instantly claimed range of about 1% to about 10%. Midha teaches the use of AMPS (Midha at [0046-0047]) polyacrylates cross polymer-6 or Sepimax Zen in a range of about 0.1% to about 10%, which overlaps the instantly claimed range of about 1% to about 5%. It would be prima facie obvious to have combined the polymers AMPS and polyacrylate cross polymer-6 as taught in Midha for the same purpose as a polymer in an oral care composition. See MPEP 2144.06(I). Deckner teaches the use of fatty amphiphiles include a combination of cetyl alcohol and stearyl alcohol in a range of about 0.1% to 20% (Deckner at 0170-0172]) which overlaps with the instantly claimed range of about 1% 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). Deckner teach that humectants including water may be present in an amount of from about 0.1% to about 99% (Deckner at [0173]). The amounts of AMPS and cetyl alcohol taught by Deckner combine in ratios that overlaps the instantly claimed ratio of from about 1.0 to about 3. Since the prior art composition contains substantially the same components in the same relative proportions as instantly claimed, it would be expected to inherently possess the same chemical and physical properties, such as viscosity in Brookfeild units and the peroxide release rate. Deckner further teaches that the composition may be a powder or a tablet which as a solid would have a Brookfeilds unit viscosity of at least 10. Deckner does not require the use of nitrate.
Regarding instant claim 2, Deckner teaches the use of hydrogen peroxide (Deckner at [0108]).
Regarding instant claim 4, Deckner teaches the use of form about 0.5% to about 10% of peroxide (Deckner at [0108]) which overlaps with the instantly claimed range of about 3% 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 5, Deckner teaches the use of form about 0.5% to about 10% of peroxide (Deckner at [0108]) which overlaps with the instantly claimed range of about 3.5% 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 6-8, Deckner teaches the use of calcium pyrophosphate (Deckner at [0083], [0091], [0094]) in an amount of 1- 10%.
Regarding instant claim 9, Deckner teaches the use of calcium pyrophosphate (Deckner at [0083], [0091], [0094]). Schweizer teaches an oral care composition wherein the percent of beta phase calcium pyrophosphate is at least 50% and the remainder of the calcium pyrophosphate is gamma phase calcium pyrophosphate (Schweizer at column 2 lines 27-36) which overlaps with the instantly claimed range for the ratio of gamma to beta phase calcium pyrophosphate of at least about 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). Schweizer teaches that this ratio is beneficial for increasing fluoride compatibility (Schweizer at column 2 lines 27-36). One would be motivated to use the ratio of Schweizer for improved fluoride capacity.
Regarding instant claim 11-16, Deckner teaches the use of sodium monofluorophosphate zinc fluoride and stannous fluoride (Deckner at [0102]).
Regarding instant claim 17, Deckner teaches the use of zinc citrate or zinc lactate (Deckner at [0204]).
Regarding instant claim 18, Deckner teaches the use of amino acids (Deckner at [0085]).
Regarding instant claim 19, Deckner teaches the use of amino acids including arginine (Deckner at [0085]).
Regarding instant claim 20, Deckner teaches that anionic surfactants such as sodium lauryl sulfate, are preferred (Deckner at 0171-0172]).
Regarding instant claim 21, Deckner teaches that anionic surfactants such as sodium lauryl sulfate, are preferred and used in a range of about 0.1% to 20% (Deckner at 0171-0172]) which overlaps with the instantly claimed range of at least about 1.5% (Deckner at 0171-0172]).
Regarding instant claim 22, Deckner teaches that anionic surfactants such as sodium lauryl sulfate, are preferred and used in a range of about 0.1% to 20% (Deckner at 0171-0172]) which overlaps with the instantly claimed range of greater than 1.5%(Deckner at 0171-0172]).
Regarding instant claim 23, Deckner teaches that anionic surfactants such as sodium lauryl sulfate, are preferred (Deckner at 0171-0172]).
Regarding instant claim 24, Deckner teaches that anionic surfactants such as sodium lauryl sulfate, are preferred (Deckner at 0171-0172]).
Regarding instant claim 26, Deckner teaches the use of AMPS (Deckner at [0105]).
Regarding instant claim 27, Deckner teaches the use of AMPS (Deckner at [0105]).
Regarding instant claim 34, Deckner teaches the use of AMPS (Deckner at [0105]). Deckner teaches the use of AMPS (Deckner at [0105]) in a range of 0.1% to 15%, which overlaps the instantly claimed range of about 1.25% to about 2.25%. Midha teaches the use of AMPS (Midha at [0046-0047]) polyacrylates cross polymer-6 or Sepimax Zen in a range of about 0.1% to about 10%, which overlaps the instantly claimed range of about 1.25% to about 2.25%. It would be prima facie obvious to have combined the polymers AMPS and polyacrylate cross polymer-6 as taught in Midha for the same purpose as a polymer in an oral care composition. See MPEP 2144.06(I).
Regarding instant claim 35, Deckner teaches the use of fatty amphiphiles include a combination of cetyl alcohol and stearyl alcohol in a range of about 0.1% to 20% (Deckner at 0170-0172]) which overlaps with the instantly claimed range of about 0.75% to about 1.25%. 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 36, Deckner teaches the use of fatty amphiphiles include a combination of cetyl alcohol and stearyl alcohol in a range of about 0.1% to 20% (Deckner at 0170-0172]). The amounts of stearyl and cetyl alcohol taught by Deckner combine in ratios that overlaps the instantly claimed ratio of from about 1:1. Deckner further teaches the use of a 1:1 ratio of stearyl and cetyl alcohol (Deckner at [0205]).
With regards to the release rate of hydrogen peroxide purely en arguendo for the compact prosecution and completeness of record.
B) Claim 1 is rejected under 35 U.S.C. 103 as being unpatentable over Deckner et al. (U.S. Patent App. Pub. 2012/0219606) and Schweizer et al (U.S. Patent 3,112,247) and of Midha et al. (U.S. Patent App. Pub. 2017/281486 A1) as applied to claims 2, 4-9, 11-24, 26-27, and 34-36 above, and further in view of Chaffer et al (US Patent Application Publication 20080274067 A1).
The teaching of Deckner, Schweizer and Midha are discussed above.
The teaching of Deckner, Schweizer and Midha differ from the instant application insofar as they do not specifically discuss peroxide release rate. The teachings of Chaffer cure this deficit.
Chaffer recites an oral care composition comprising an active agent e.g. a whitening agent, and a carrier including a carrier base comprising a wax and a substantivity agent (Chaffer at claim 1). Chaffer recites wherein the active agent comprises a whitening agent (Chaffer at claim 5). Chaffer recites wherein the active agent comprises an antimicrobial compound, mineralization compound, desensitization compound, anti-calculus agents, anti-inflamatory agents or anti-oxidants (Chaffer at claim 6). Chaffer recites wherein the whitening agent comprises a peroxide whitening agent and the composition further comprises a peroxide releasing agent (Chaffer at claim 7). Chaffer recites a method of whitening teeth comprising applying onto teeth a composition, for a period of time sufficient to produce an improvement in the whiteness of the teeth (Chaffer at claim 10). Chaffer recites a method of preparing a composition which method comprises an admixture of components of the composition (Chaffer at claim 11). Chaffer teaches that the whitening agent includes a peroxide whitening compound e.g. hydrogen peroxide, carbamide peroxide, calcium peroxide, persulfate salts, percarbonate salts, perborate salts, PVP-peroxide complexes, entrapped or encapsulated forms of peroxide, STP, metal chlorites such as calcium chlorite, barium chlorite, magnesium chlorite, sodium chlorite and potassium chlorite; peroxyacids, persulfates, chlorine dioxide, other hydrogen peroxide complexes and mixtures thereof. (Chaffer at [0013]). Chaffer teaches that the whitening agent is used in an amount ranging from 0.1 to 35% w/w of the composition, preferably 2 to 15% w/w based on the hydrogen peroxide or the proportional amount of active oxygen based on the whitening moiety (Chaffer at [0014]). Chaffer teaches that the compositions of the invention may comprise an active releasing agent to improve release of the agent on hydration in the oral cavity. Although not bound by any particular mechanism of action, the inventors believe that such an agent provides hydration channels in the composition milieu, allowing water to penetrate the composition and allowing the active component to leach out. When a peroxide whitening agent is used the composition comprises a peroxide releasing agent. Suitable peroxide releasing agents include water-soluble/swellable polymers e.g. xanthan gum, polyvinyl pyrrolidone, polyacrylic acid, maleic acid copolymers, polyvinyl alcohol, PEG, PPG, copolymers of PEG and/or PPG, and other suitable polymers containing either repetitive alcohol or organic acid functionalities. Xanthan gum may perform a dual role in a composition according to the invention, acting as both a substantivity agent and as a peroxide releasing agent (Chaffer at [0017]). Chaffer teaches that the peroxide releasing agent is used in an amount ranging from 0.5 to 20-% w/w of the composition, preferably from 2 to 10% w/w of the composition. The peroxide releasing agent may be utilized to control the release rate of peroxide e.g. more releasing agent for faster release and less for a slow release. (Chaffer at [0013]). Chaffer teaches the use of water-soluble salts of fluoride e.g. sodium fluoride, potassium fluoride and stannous fluoride, sodium fluorosilicate and ammonium fluorosilicate; mineralization combinations e.g. calcium salt/phosphate salt, calcium salt/ionic fluoride sources, zinc salt/phosphate salt (Chaffer at [0032]). Chaffer teaches the use of pyrophosphates (Chaffer at [0032]). Chaffer teaches that water is present in a range from 5 to 10% (Chaffer at [0023]). Chaffer does not require a nitrate.
It would be prima facie obvious to have optimized the release rate of the peroxide in the compositions of Deckner, Schweizer and Midha order to control the degree or speed of whitening and the length of utility in the oral cavity as taught by Chaffer. See MPEP 2144.05(II).
Response to Arguments
Applicant's arguments filed 11/13/2025 have been fully considered but they are not persuasive.
Applicant argues that the unexpected results of tables 2 and 3 overcome the prima facie case of obviousness.
The Examiner does not agree. Any differences between the claimed invention and the prior art may be expected to result in some differences in properties. The issue is whether the properties differ to such an extent that the difference is really unexpected. In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). See MPEP 716.02. The burden is on Applicant to describe the practical and statistical significance of the data. Applicant has not to best of the Examiners understanding provided statistical information for the data nor explained the practical significance of the results. The evidence relied upon should establish "that the differences in results are in fact unexpected and unobvious and of both statistical and practical significance." Ex parte Gelles, 22 USPQ2d 1318, 1319 (Bd. Pat. App. & Inter. 1992). See MPEP 716.02(b)(I). Further it is the Applicants burden to explain the data provided. "[A]ppellants have the burden of explaining the data in any declaration they proffer as evidence of non-obviousness." Ex parte Ishizaka, 24 USPQ2d 1621, 1624 (Bd. Pat. App. & Inter. 1992). See MPEP 716.02(b)(II). With regards to Table 2, the table provides data only within the claimed ranges there is no upper or lower example showing an incompatible BKU with less than or more than the amount or range taught. Therefore, it is difficult to draw unexpected results when all of the compositions are within range and there is nothing to compare them against. Furthermore, even if data were unexpected the claims are not within the scope of the data provided. The data provides up to 2.25% for the polyacrylate crosspolymer-6 and up to 1.25 for the alcohols. The independent instant claim recites up to 5% for each which is not presently supported by the data. With regards to Table 3, there is only one data point provided in the table a 1:1 ratio with both components at 1.6%. The data does not include a control of 3.2% of each component, polyacrylate crosspolymer-6 and the alcohols, separately to ensure the additional mass of thickener is not responsible for the BKU increase, which makes it difficult to determine unexpected results. Even if, purely arguendo, the results were synergistic they would only support the very close range of a 1:1 ratio of polyacrylate crosspolymer-6 and the alcohols at a the very specific amount of 1.6%. As such, no unexpected results have been established and the obviousness rejection stands.
Relevant Prior Art
Midha et. al. (U.S. Patent App. Pub. 2017/0027849 A1)
Midha recites an oral care composition comprising greater than about 0.5% peroxide selected from the group consisting of hydrogen peroxide, urea peroxide, calcium peroxide, sodium peroxide, zinc peroxide, or combinations thereof; a 2-acrylamido-2-methylpropane sulfonic acid polymer, copolymer, and/or cross polymer; and a fluoride ion source selected from the group consisting of stannous fluoride, sodium fluoride, potassium fluoride, amine fluoride, sodium monofluorophosphate, indium fluoride, amine fluorides, and combinations thereof (Midha at claim 1). Midha further recites wherein the 2-acrylamido-2-methylpropane sulfonic acid polymers, copolymers, and/or cross polymers is polyacrylate crosspolymer-6 (Midha at claim 2). Midha further recites wherein the peroxide is hydrogen peroxide (Midha at claim 4). Midha further recites wherein the composition further comprises from about 0.5% to about 7% fatty alcohol (Midha at claim 6). Midha further recites wherein the viscosity of the composition is from about 10 BKUs to about 70 BKUs (Midha at claim 15).Midha further recites an abrasive selected from the group consisting of silica, polyorganosilsequioxane, calcium pyrophosphate, poly(methyl methacrylate), calcium carbonate, dicalcium phosphate, barium sulfate, and combinations thereof (Midha at claim 16). Midha further recites greater than about 10% water (Midha at claim 16). Midha further teaches the use of stannous fluoride (Midha at [0065]) and zinc lactate (Midha at [0067]).
Hoke et al (U.S. Patent App. Pub. 2017/0281493 A1)
Hoke et al recites a composition comprising at least 4% fatty amphiphile; from about 2% to about 25%, by weight of the composition, abrasive; a fluoride ion source selected from the group consisting of stannous fluoride, sodium fluoride, potassium fluoride, amine fluoride, sodium monofluorophosphate, indium fluoride, amine fluoride, and combinations thereof; and from about 1% to about 90% water (Hoke at claim 17). Hoke further recites wherein the composition further comprises from about 0.5% to about 10%, by weight of the composition, of a peroxide compound (Hoke at claim 20). Hoke teaches that the composition can comprise 1% to 40% sodium lauryl sulfate (Hoke at [0088]). Hoke further teaches the use of zinc lactate (Hoke at [000102]), stannous fluoride (Hoke at [0101]), sodium monofluorophosphate (Hoke at [0098]), hydrogen peroxide (Hoke at [0119]). Hoke teaches the use of AMPS polymer, aka 2-acrylamido-2-methylpropane sulfonic acid polymer in an amount from between 1% and 10% (Hoke at [00115-0117]). Hoke teaches the use of calcium pyrophosphate (Hoke at [0127]).
Midha et al (U.S. Patent App. Pub. 2017/0281476 A1)
Midha recites an oral care composition comprising from about 3% to about 17% fatty amphiphile, an abrasive, and a fluoride ion source selected from the group consisting of stannous fluoride, sodium fluoride, potassium fluoride, amine fluoride, sodium monofluorophosphate, indium fluoride, amine fluoride, and combinations thereof (Midha at claim 1). Midha recites wherein the fatty amphiphile comprises a fatty alcohol selected from the group consisting of cetyl alcohol, stearyl alcohol, and combinations thereof (Midha at claim 3). Midha recites wherein the composition has a viscosity from about from about 10 BKUs to about 45 BKUs (Midha at claim 8). Midha recites wherein the composition further comprises from about 25% to about 70% water (Midha at claim 9). Midha recites wherein the composition further comprises a peroxide component selected from the group consisting of hydrogen peroxide, urea peroxide, calcium peroxide, sodium peroxide, zinc peroxide, polyvinylpyrrolidone peroxide complex or combinations thereof (Midha at claim 1). Midha recites wherein the composition comprises 1% or more peroxide (Midha at claim 11) and wherein the peroxide is hydrogen peroxide (Midha at claim 12). Midha recites wherein the composition further comprises 2-acrylamido-2-methylpropane sulfonic acid (AMPS) polymer (Midha at claim 14). Midha further teaches the use of zinc lactate (Midha at [0070]) and calcium pyrophosphate (Midha at [0103]).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1-2, 4-9, 11-24, 26-27, and 34-36 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8,10-13,15-28,31-32, 35-36 and 38 of copending Application No. 17,577,402 in view of Deckner et al. (U.S. Patent App. Pub. 2012/0219606) and Schweizer et al (U.S. Patent 3,112,247) in view of Midha et al. (U.S. Patent App. Pub. 2017/281486 A1).
The instant application recites an oral care composition comprising a peroxide, amphiphilic polymer, alkyl alcohol, and water wherein the ratio of alkyl alcohol to amphiphilic polymer is at least about 0.5. The instant application further recites an oral care composition comprising peroxide, amphiphilic polymer, alkyl alcohol and at least 1.5 % by weight of the composition sodium alkyl sulfate surfactant.
The copending ‘402 application recites an oral care composition comprising peroxide, calcium pyrophosphate, and water wherein the oral care composition comprises a ratio of gamma phase calcium pyrophosphate to beta phase calcium pyrophosphate of at least about 0.8 (‘402 at claim 1). ‘402 recites an oral care composition wherein the peroxide comprises hydrogen peroxide, urea peroxide, carbamide peroxide, calcium peroxide, sodium peroxide, zinc peroxide, sodium percarbonate, polyvinylpyrrolidone-hydrogen peroxide complex, cross-linked polyvinyl pyrrolidone- hydrogen peroxide complex, or combinations thereof (‘402 at claim 2). ‘402 recites an oral care composition wherein the oral care composition comprises at least about 1%, by weight of the oral care composition, of the peroxide (‘402 at claim 3). ‘402 recites an oral care composition wherein the oral care composition comprises at least about 3%, by weight of the oral care composition, of the peroxide (‘402 at claim 4). ‘402 recites an oral care composition wherein the oral care composition comprises at least about 3.5%, by weight of the oral care composition, of the peroxide. (‘402 at claim 5). ‘402 recites an oral care composition wherein the oral care composition comprises from about 5%, to about 75%, by weight of the oral care composition, of the water (‘402 at claim 6). ‘402 recites an oral care composition wherein the oral care composition comprises from about 1%, to about 30%, by weight of the oral care composition, of the calcium pyrophosphate (‘402 at claim 7). ‘402 recites an oral care composition wherein the oral care composition comprises from about 1% to less than 15%, by weight of the oral care composition, of the calcium pyrophosphate (‘402 at claim 8). ‘402 recites an oral care composition wherein the ratio of gamma phase calcium pyrophosphate to beta phase calcium pyrophosphate is at least about 1 (‘402 at claim 9). ‘402 recites an oral care composition comprising sodium monofluorophosphate (‘402 at claim 13), stannous chloride (‘402 at claim 16), zinc lactate (‘402 at claim 17), arginine (‘402 at claim 20), sodium lauryl sulfate (‘402 at claim 24), 2- acrylamido-2-methylpropane sulfonic acid polymer, copolymer, cross polymer, or combination thereof (‘402 at claim 28) and cetyl alcohol, stearyl alcohol, or combinations thereof (‘402 at claim 32). ‘402 recites an oral care composition wherein the oral care composition comprises greater than 1.5%, by weight of the oral care composition of anionic surfactant (‘402 at claim 22). ‘402 recites an oral care composition is a dentifrice (‘402 at claim 10).
‘402 does not recite the viscosity of the composition. The teachings of Midha, Schweizer, and Deckner cure this deficit.
The teachings of Midha, Schweizer, and Deckner are discussed above.
It would have been prima facie obvious to one of ordinary skill in the art following the claims of the copending ‘402 application to have formatted the dentifrice having an appropriate viscosity such as that taught by Midha (i.e.10 to 45 BKU). One would have had a reasonable expectation of success because both Midha and the copending ‘402 application teach oral care dentifrices comprising peroxide, calcium pyrophosphate, alkyl alcohols, amphiphilic polymers, and water. Further, one would have been motivated to optimize the viscosity of the dentifrice to produce the desired texture and mouthfeel for the user. See MPEP 2143 (A) and MPEP 2144.05(II).
This is a provisional nonstatutory double patenting rejection.
Response to Arguments
Applicant states that upon indication of otherwise allowable subject matter, Applicant will consider filing a terminal disclaimer if necessary.
Since terminal disclaimers have not yet been filed, the non-statutory double patenting rejections are maintained.
Conclusion
No claims are currently 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
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/AMANDA MICHELLE PETRITSCH/Examiner, Art Unit 1612
/SAHANA S KAUP/Supervisory Primary Examiner, Art Unit 1612