DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 08/10/2026 has been entered.
Applicants' arguments, filed 08/10/2026, 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 Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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.
Claim Rejections - 35 USC § 112—New by Amendment
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 22 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 22 recites the limitation "the silica abrasive" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim.
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 22 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 22 recites “wherein the silica abrasive is a high cleaning abrasive”. However, since the independent claim 1 has been amended to recite “an abrasive system consisting of 5-20 wt.% of calcium pyrophosphate abrasive” no other abrasive can be added. The transitional phrase “consisting of” prevents the addition of any other abrasive. Accordingly, claim 22, requiring high cleaning silica, fails to further limit claim 1. 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—Previous
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.
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.
1) Claim(s) 1-2, 4-15, 17, 21-23 remain rejected under 35 U.S.C. 103 as being unpatentable over Merianos et al., (US 5,130,124) in view of Chopra et al., (US 2013/0287710) and further in view of Milanovich et al., (US 2005/0271601).
Merianos et al. teaches, “a stabilized, aqueous, film-forming, antimicrobial composition of hydrogen peroxide”, wherein the hydrogen peroxide “is stabilized in an aqueous-polyol solvent system of predetermined polarity containing PVP” (Abstract). “Suitably, the composition herein includes about 1-20% by weight hydrogen peroxide, about 0.1-50% by weight PVP, and about 0.1-80% by weight of a polyol, the rest being water. Preferably, about 5-20% by weight of water is present in the composition” (Id.), as per claims 1, 4, 7, 10, 15-16, 21. Here, the aqueous hydrogen peroxide is the only oxidizing agent in the composition.
Since PVP (polyvinylpyrrolidone) is the only thickener required in Merianos et al., it would have been obvious for prior art to have a thickening system consisting of 5-20% polyvinylpyrrolidone and 3-4% fumed silica (taught below).
Given the overlapping range amounts of water and hydrogen peroxide, it would have been obvious to have about an equal amount of water and hydrogen peroxide by weight, as per claim 5.
It is the object of the prior art invention to provide a “composition of hydrogen peroxide which has a stable shelf-life, is capable of being retained on the oral tissue for extended periods of time” and “which can be formulated in situ from an aqueous hydrogen peroxide solution, a stabilizing, film-forming and complexing agent capable of complexing with hydrogen peroxide in a defined molar ratio” (col. 1, lines 62-col. 2, line 5).
Given the range amounts of polyvinylpyrrolidone and hydrogen peroxide, it would have been obvious for the compositions to have the weight ratios, as per claim 14.
Here, the hydrogen peroxide-pvp complex is taught to be formed in situ, i.e. not added to the composition during manufacture, as per claims 6, 11.
The hydrogen peroxide is further taught to be “added as 30-70% aqueous solution”, as per claims 1-2 (see table at col. 2).
The PVP (polyvinylpyrrolidone) is taught to be “added as a K-15 to K-90, water soluble or water-insoluble powder) (Id.). Since suitable pvp includes water soluble or water insoluble types, the artisan would have been reasonably expected to utilize non-crosslinked and crosslinked pvp, e.g. povidone and cPVP, as per claim 16 (see Technological Background below for support).
The compositions are effective as a “mouthwash” or “toothpaste” (col. 2, lines 67- col. 3, line 1).
Optional components include “Wetting, emulsifying, surfactant and suspending agents” (Table at col. 2).
The prior art teaches a specific embodiment comprising “a 70% aqueous solution of H2O2 (9.1 g H2O2), 42.5 g of PVP (soluble PVP-K-15, <1% water), 42.6 g of propylene glycol and 5 g of water. After 5 months at 40ºC. in an oven closed off from air, the H2O2 content was analyzed at 9.5%” (col. 3, lines 10-20, Example 1A). Accordingly, the artisan would have reasonably expected “about 5% or less of hydrogen peroxide degradation when stored at a temperature of 40ºC for 4 weeks” from the prior art compositions.
Here, the amount of propylene glycol is approximately 43% by weight of the composition, and is the only polyol, as per claims 1, 8-9, 17.
Use of metal ion chelating agents, as per claim 13, are not taught by the prior art. Accordingly, it would have been obvious to exclude them.
Merianos does not teach fumed silica, calcium pyrophosphate or a polyethylene glycol/polypropylene glycol random copolymer.
Chopra et al. teaches, “Oral care compositions comprising a crosslinked polyvinylpyrrolidone complexed with hydrogen peroxide, together with an ethylene oxide-propylene oxide block copolymer. Some embodiments further comprise a calcium abrasive, e.g. calcium pyrophosphate . . . “ (Abstract).
Calcium pyrophosphate may be present in an amount of “less than 20%” (p. 3, para. [0051]), as per claims 15.
Ethylene oxidex-propylene oxidey block copolymers can be present from “1-15%, e.g. about 5%” (p. 3, table at para. [0046]), as per claims 12, 15-16, including wherein the integer x is 80-150, and y is 30-80 (Id. at para. [0039]).
The compositions further comprise fumed silica (silica abrasive), as thickening agent, where “[o]ne or more thickening agents are optionally present in total amount of 0.1% to about 90%” (p. 4, para. [0060]), as per claims 15-16; tartar control agents, e.g. tetrasodium pyrophosphate (TSPP) (p. 4, para. [0056]); “humectants, mouth feel agents, sweetening agents, flavor agents, colorants, preservatives, and combinations thereof” (p. 4, para. [0062]).
Chopra et al. teaches a specific single phase/single component embodiment of a dentifrice gel comprising 7.5% PEG118/PPG66 co-polymer (polyethylene glycol/polypropylene glycol co-polymer), 25% propylene glycol, 5.5% crosslinked PVP/H2O2, 0.76% sodium monofluorophosphate, 2% TSPP, 10% calcium pyrophosphate, 0.03% BHT (antioxidant), 2% sodium lauryl sulfate, 2% Flavor (p. 6, Example 2, Table 2, para. [0078]), as per claims 15-16.
Here, calcium pyrophosphate is the only abrasive. Accordingly, it would have been obvious to provide an abrasive system consisting of 5-20% calcium pyrophosphate.
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).
“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 filing to add fumed silica, calcium pyrophosphate and a polyethylene glycol/polypropylene glycol random copolymer to the compositions of Merianos et al., including sodium lauryl sulfate, tetrasodium pyrophosphate, sodium monofluorophosphate, flavoring agents, antioxidants (e.g. BHT), and preservatives, based on their art recognized suitability for their intended use in oral care compositions comprising complexes of PVP and hydrogen peroxide, as taught by Chopra et al.
The combination of Merianos et al. and Chopra et al., which is taught above, differs from claim 1 and 22 insofar as it does not teach a pH of 5.5-7.5 or a high cleaning silica abrasive.
Milanovich et al. teaches anti-staining antibacterial dentifrices (Abstract) including “one or more peroxy compounds” (p. 5, para. [0054]).
Concerning pH, Milanovich et al. teaches, “one or more compounds selected from acidifying, basifying and buffering agents can be included to provide a pH of about 2 to about 10, or in various illustrative embodiments about 2 to about 8, about 3 to about 9, about 4 to about 8, about 5 to about 7, about 6 to about 10, about 7 to about 9, etc.” (p. 8, para. [0078]).
The reference further teaches, “In a particular embodiment the composition comprises one or more high-cleaning silicas (HCS) to enhance whitening performance of the dentifrice by mechanically removing existing stain and debris from a dental surface by means of HCS” (p. 6, para. [0076]).
It would have been obvious to a person having ordinary skill in the art at the time of applicant’s filing to provide a pH of 5.5-7.5 in Merianos et al., since a pH of about 5 to about 7 is suitable for oral care compositions having peroxide, as taught by Milanovich. It would have also been obvious to add a high-cleaning silica to the compositions of Merianos et al. for the advantage of enhancing its whitening performance by mechanically removing existing stain and debris from a dental surface by means of high-cleaning silica, as taught by Milanovich et al.
Concerning claim 23, since Meriano et al. only requires hydrogen peroxide, pvp, polyol, and water, it would have been obvious to formulate a composition consisting of these ingredients plus fumed silica, anionic surfactants, pyrophosphates, fluoride, flavoring, calcium pyrophosphate and copolymer from Chopra et al., and pH from Milanovich et al.
2) Claim(s) 16 remains rejected under 35 U.S.C. 103 as being unpatentable over Merianos et al., (US 5,130,124) in view of Chopra et al. (US 2013/0287710) and further in view of Milanovich et al., (US 2005/0271601) as applied to claim 1 above, and further in view of Prencipe et al., (US 2015/0366766).
The combination of Merianos et al., Chopra et al., and Milanovich, which is taught above, differs from claim 16 insofar as it does not teach disodium pyrophosphate (DSPP).
Prencipe et al. teaches “oral care compositions comprising . . . a crosslinked polyvinylpyrrolidone complexed with hydrogen peroxide” and “sodium acid pyrophosphosphate (Na2H2P2O7) [disodium pyrophosphate] in an amount of from 0.05 wt% to 5 wt% based on the weight of the composition (Abstract).
Prencipe et al. further teaches, “The inventors have unexpectedly found that sodium acid pyrophosphate (Na2H2P2O7), otherwise referred to as SAPP or disodium pyrophosphate, can increase both the chemical peroxide stability and the physical phase stability in dentifrice including a peroxide whitening agent in the form of a whitening complex” (p. 2, para. [0026]).
It would have been obvious to a person having ordinary skill in the art at the time of applicant’s filing to add disodium pyrophosphate to the dentifrice compositions of Merianos et al. for the advantage of increasing both the chemical peroxide stability and the physical phase stability of the dentifrice, as taught by Prencipe et al.
Technological Background
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure Kurakula et al. (Journal of Drug Delivery Science and Technology, 2020). Kurakula et al. is pertinent for teaching that water-insoluble forms of PVP are crosslinked, e.g. crospovidone (p. 3, Table 2; see also sec. 4.2.3).
Response to Arguments
Applicant argues that the rejection should be withdrawn in view of the amendments. However, the rejection will be maintained for the reasons give above in the rejection.
Applicant also argues, “Merianos does not establish or even teach that its peroxide/PVP/polyol/water mixtures would have adequate stability in the presence of the claimed abrasive system and/or the claimed thickening system.
However, the compositions of Merianos are designed for the stability of hydrogen peroxide (see Example 1 of Merianos at col. 3). There is nothing in Merianos to suggest that the claimed ingredients would made inadequate the stability of hydrogen peroxide in the compositions of Merianos. In other words, the artisan would have not expected inadequate stability of hydrogen peroxide form the claimed ingredients if added to the compositions of Merianos.
Conclusion
All claims are identical to or patentably indistinct from, or have unity of invention with claims in the application prior to the entry of the submission under 37 CFR 1.114 (that is, restriction (including a lack of unity of invention) would not be proper) and all claims could have been finally rejected on the grounds and art of record in the next Office action if they had been entered in the application prior to entry under 37 CFR 1.114. Accordingly, THIS ACTION IS MADE FINAL even though it is a first action after the filing of a request for continued examination and the submission under 37 CFR 1.114. See MPEP § 706.07(b). 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.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
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