DETAILED ACTION
Claims 1-2, 4, 6, 9-10, 12-13, 15-17, 19-20, 22, 24-30 are currently pending. Claims 1-2, 4, 6, 9, 12-13, 15-17, 19, 25-30 are currently under examination.
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 .
Withdrawn Rejections
The prior rejection of claim 6 and 12-13 under 112(b) is withdrawn in light of Applicant’s claim amendments to remove preferably language, which the Examiner finds persuasive.
Examiner’s Note
Applicant's amendments and arguments filed 01/16/2026 are acknowledged and have been fully considered. The Examiner has re-weighed all the evidence of record. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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. In the Applicant’s response, filed 01/16/2026, it is noted that claims 6, 12-13, 17 have been amended and claims 25-30 are newly added. No new matter or claims have been added.
Modified Rejections:
The following rejections are modified based on Applicant’s claim amendments and newly added claims.
Claim Rejections - 35 USC § 103
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.
Claim(s) 1-2, 4, 6, 9, 12-13, 15 and 25-30 is/are rejected under 35 U.S.C. 103 as being unpatentable over WO 95/16023 (previously applied) as evidenced by GuideChem (GuideChem, Acusol 820, pgs. 1-2).
Regarding claims 1-2, 4, 6, 25-26, the limitation of a system for preparing a peroxide composition, the system comprising a first composition comprising a peroxide agent and water having a pH lower than 7, a second component comprising an amount of basic agent, and amount of pH induced thickener capable of thickening an aqueous composition upon an increase of the pH of this aqueous compristion from an acidic o an alkaline value, the pH induced thickener being present in a solvent in which the pH induced thickener is dissolved and is a HASE polymer; the peroxide compristion being obtainable by combining the first composition and the second composition to induce thickening and the amount of the basic agent being sufficient for causing the peroxide composition to have a compristion pH in the range of 7 to 12 is met by the ‘023 publication teaching two separate liquid compositions, a first of which contains an acid or neutral compristion, which comprises a peroxide and a second of which contains an alkaline compristion, said first and second composition being stored separately and sprayed form a single unit to a common point (abstract, page 5, lines 1-10). Peroxide solutions are taught to be aqueous (page 6, lines 20-30). Thickeners can be present in the at least one of the first and second compristion (page 9, lines 10-20). The thickeners are taught to thicken when the components are mixed (page 9, lines 30-35). Suitable thickeners only thicken at alkaline pH and include Acusol820 an acrylate copolymer that form a viscous gel at pH 6, whereas very little thickening is exhibited at pH 3.0 (page 10, lines 20-35). The instant specification teaches Acusol 820 is an acrylic HASE polymer is the preferred polymer (page 7, lines 25-35) and GuideChem provides the structure of Acusol 820 (page 1). Simultaneous spraying of the first and second compositions is taught (page 15, lines 10-25). The ‘023 publication teaches thickening at a pH of 6, wherein the pH of mixing the first and second composition to obtain gelling is an optimizable parameter. As MPEP 2144.05 recites “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine optimization”.
Regarding claim 9, the limitation of wherein the first composition comprise the pH induced thickener in the solvent and/or dispersion medium containing form; and/or wherein the second composition water and has a second pH higher than 7 is met by the ‘023 publication teaching two separate liquid compositions, a first of which contains an acid or neutral compristion, which comprises a peroxide and a second of which contains an alkaline compristion, said first and second composition being stored separately and sprayed form a single unit to a common point (abstract, page 5, lines 1-10). Peroxide solutions are taught to be aqueous (page 6, lines 20-30). Thickeners can be present in the at least one of the first and second compristion (page 9, lines 10-20). The thickeners are taught to thicken when the components are mixed (page 9, lines 30-35). Suitable thickeners only thicken at alkaline pH and include Acusol810 an acrylate copolymer that form a viscous gel at pH 6, whereas very little thickening is exhibited at pH 3.0 (page 10, lines 20-35). The ‘023 publication teaches thickening at a pH of 6, wherein the pH of mixing the first and second composition to obtain gelling is an optimizable parameter. As MPEP 2144.05 recites “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine optimization”.
Regarding claims 12 and 27-28, the limitation of wherein the first composition and the second composition are sufficient to mix them in a ratio of the first composition to the second compristion in a arrange of 10 to 0.1 is met by the ‘023 publication teaching a mixing ratio of 2:1 to 1:2 (page 7, lines 2-25).
Regarding claims 13, 15 and 29-30, the limitation of wherein the first composition comprises a solvent and/or dispersion medium and has a viscosity lower than 1000 mPas is met by the ‘023 publication teaching the thickener present in the peroxide compristion wherein low viscosity is exhibited wherein the pH of the first composition is acidic (page 10, lines 10-25). As MPEP 2144.05 recites “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine optimization”.
It must be remembered that “[w]hen a patent simply arranges old elements with each performing the same function it had been known to perform and yields no more than one would expect from such an arrangement, the combination is obvious”. KSR v. Teleflex, 127 S,Ct. 1727, 1740 (2007)(quoting Sakraida v. A.G. Pro, 425 U.S. 273, 282 (1976)). “[W]hen the question is whether a patent claiming the combination of elements of prior art is obvious”, the relevant question is “whether the improvement is more than the predictable use of prior art elements according to their established functions.” (Id.). Addressing the issue of obviousness, the Supreme Court noted that the analysis under 35 USC 103 “need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ.” KSR v. Teleflex, 127 S.Ct. 1727, 1741 (2007). The Court emphasized that “[a] person of ordinary skill is… a person of ordinary creativity, not an automaton.” Id. at 1742.
Consistent with this reasoning, it would have been obvious to have selected various combinations of disclosed ingredients (for example the pH induced thickener in the peroxide composition and a second alkaline composition) from within the prior art disclosure of the ‘023 patent, to arrive at the instantly claimed peroxide composition “yielding no more than one would have expected from such an arrangement”.
Claim(s) 1-2, 4, 6, 9, 12-13, 15-16 and 25-30 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 6,503,485 (IDS dated 03/21/2022) in view of WO 95/16023 (previously applied) as evidenced by GuideChem (GuideChem, Acusol 820, pgs. 1-2).
Regarding claims 1 and 15, the limitation of a system for preparing a peroxide composition, the system comprising: a first component comprising peroxide agent and water and having a pH lower than 7, a second composition separate from the first composition comprising an amount of an acidic agent, is met by the ‘485 patent teaching the ‘485 patent teaching dental bleaching systems that include ab leaching component and a neutralizing component, when mixed together yield the desired bleaching activity and viscosity, wherein the bleaching compristion includes a suitable bleaching agent such as hydrogen peroxide and the neutralizing component includes a thickening agent and a base such as hydroxides (abstract). The pH of the bleaching composition is less than about 5 (column 6, lines 15-25). Upon mixing the two components the pH is between about 5 and 9 (column 4, lines 15-25).
Regarding claims 12, and 27-28 the limitation of wherein the first comprising and the second composition are sufficient to mix them in a ratio of the first composition to the second comprising in a range of 10 to 0.1 is met by the ‘485 patent teaches the ratio of part 1 to part two will be in the range of about 1:2 to 5:1 (column 7, lines 55-67).
Regarding claim 16, the limitation of comprising one or more selected from a group including flavoring agent is met by the ‘485 patent teaching flavorants (column 6, lines 5-20).
The ‘485 patent does not specifically teach an amount of a pH induced thickener capable of thickening an aqueous composition upon an increase of the pH of the aqueous composition from an acidic to an alkaline value, the pH induced thickener being present in the system in a solvent and/or dispersion medium in which the pH induced thickener dissolved and is a HASE polymer (claim 1) wherein the Has polymers are not crosslinked (claim 2) and fall within the formula of claim 6.
The ‘023 publication teaches two separate liquid compositions, a first of which contains an acid or neutral compristion, which comprises a peroxide and a second of which contains an alkaline compristion, said first and second composition being stored separately and sprayed form a single unit to a common point (abstract, page 5, lines 1-10). Peroxide solutions are taught to be aqueous (page 6, lines 20-30). Thickeners can be present in the at least one of the first and second compristion (page 9, lines 10-20). The thickeners are taught to thicken when the components are mixed (page 9, lines 30-35). Suitable thickeners only thicken at alkaline pH and include Acusol820 an acrylate copolymer that form a viscous gel at pH 6, whereas very little thickening is exhibited at pH 3.0 (page 10, lines 20-35). The instant specification teaches Acusol 820 is an acrylic HASE polymer is the preferred polymer (page 7, lines 25-35) and GuideChem provides the structure of Acusol 820 (page 1). Simultaneous spraying of the first and second compositions is taught (page 15, lines 10-25). The ‘023 publication teaches thickening at a pH of 6, wherein the pH of mixing the first and second composition to obtain gelling is an optimizable parameter. As MPEP 2144.05 recites “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine optimization”. the ‘023 publication teaching the thickener present in the peroxide compristion wherein low viscosity is exhibited wherein the pH of the first composition is acidic (page 10, lines 10-25). As MPEP 2144.05 recites “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine optimization”.
It would have been prima facie obvious to one of ordinary skill in the art before the filing date of the claimed invention to use Acusol 820 as the thickening polymer in the peroxide composition of the dental bleaching composition because the ‘485 patent teaches a two part bleaching composition including a peroxide and alkaline compositions and a thickening polymer and the ‘023 publication teaches Acusol820 used a thickening polymer in a two part peroxide composition and alkaline composition system, thus the ‘485 patent and the ‘023 publication are directed to two part compositions containing thickening polymer, peroxide composition and an alkaline composition. One of ordinary skill in the art would be motivated to include Acusol 820 in the peroxide composition as the ‘485 patent teaches the composition to contain a thickening agent and the ‘023 publication teaches Acusol 820 to be a thickening agent known to be used in a peroxide containing compositions to thicken the composition once combined. It would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention the thickening agent may be used in the peroxide containing composition as the ‘023 publication teaches thickening polymer to be used in either the first or second compositions. One of ordinary skill in the art before the filing date of the claimed invention would be motivated to use Acusol 820 in the composition of the ‘485 patent as the ‘023 publication teaches the thickening agent to only thicken when mixed so as to not run off the application surface.
Claim(s) 17 and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 6,503,485 in view of WO 95/16023 as evidenced by GuideChem (GuideChem, Acusol 820, pgs. 1-2) as applied to claims 1-2, 4, 6, 9, 12-13, 15-16 and 25-30 above, and further in view of US 10,918,574 (previously applied) and US 2004/0062723 (IDS dated 03/21/2022, previously applied).
As mentioned in the above 103(a) rejection, all of the limitations of claims 1-2, 4,6,9,12-13, 15-16 and 25-30 are taught by the combination of the ‘485 patent and the ‘023 publication.
Regarding claim 19, the limitation of for providing the peroxide composition for use as an orally applicable tooth whitening compristion or a disinfectant composition in the prevention or treatment of oral infections is met by the ‘485 patent teaching a multi-part dental bleaching system (claim 1) wherein the mixture is applied to a person’s teeth (claim 29).
The combination of references does not specifically teach mixing compartment attachable to or attached to the multicompartment syringe for receiving and mixing the respective quantities and the amount of pH induced thickener and having an outlet for permitting the resulting peroxide compristion to exit the syringe, syringe upon the use of the syringe, wherein the dispersing system comprising a mixing unit, a user interface for enabling a user to provide input parameter relating to at least one of use of the peroxide composition and a selectin module for controlling the mixing unit to determine the quantities of components to be combine for the peroxide compristion base on the input parameter (claim 17).
The ‘723 publication teaches a dual component tooth whitening compristion (title) whereby the components are mixed and combined for the first time and exposure to the surface of teeth to obtain minimal tooth sensitivity (abstract). Double barreled syringes are taught as useful for dispensing the dual copoint whitening composition. Dual component compositions of the present invention use double barreled syringe adapted of mixing and dispending two component viscous material. Chambers in the syringe are filled with the appropriate amount of the dentifrice components. The double barreled syringe are equipped with a plunger for dispersing equal weight amount of the components to form an admixture which simultaneously discharged and having static mixing [0043].
The ‘574 patent teaches systems and methods for dispensing and administering precise, customized doses of one or more preparation constituents (abstract, column 1, lines 60-67, column 2, lines 1-10). The ‘574 patent teaches an embodiment where a liquid or fluid is dispensed from a dual chamber module, each separately housing a different preparation or liquid (column 2, lines 35-55). The ‘574 patent further teaches that a user interface may be used to control the dispensing device and teaches that the dispensed dose can be tailored to a specific target individual by using the user interface to enter constituent amounts and ratio information (column 3, lines 30-60).
It would be obvious to one skilled in the art to use the ‘574 patent user interface in 723 publication’s two component hydrogel dispensing system for administrating the whitening composition taught by the ‘485 patent with a reasonable expectation of administering precise, customized doses of the ‘485 patent whitening composition. Since the ‘574 patent teaches that both the amounts and the ratio of the constituents may be selected using the user interface, it is the Examiner’s position that both the user interface and selection module limitation of claim 14 are inherently taught by the ‘574 patent and one would be motivated to a dual chamber syringe with mixing component and user modified interface as taught by the ‘574 patent and the ‘723 publication to administer the whitening composition of the ‘485 patent as the ‘485 patent teaches a wide range of ratio of components that can be used and would be capable of obtained the desired viscosity.
Response to Arguments:
Applicant’s arguments have been fully considered and are not deemed to be persuasive.
103: The ‘023 publication (Smith)
Applicant argues the ‘023 publication expressly teaches placing an acrylate thickener in an alkaline component and using a different thickener (cellulose derivative) in an acidic peroxide composition to address spray behavior and mist. This is a classic teaching away from the claimed configuration (page 9, lines 25-29, page 10, lines 28-35). The ‘023 publication teaches the skilled artisan to put cellulose-type thickeners in the acidic peroxide component to avoid mist and to achieve proper spray behavior. This is the opposite of the claimed system which requires the HASE thickener to be dissolved/dispersed at the first acidic pH.
In response, the ‘023 publication teaches the thickener is originally present in an acidic, peroxide compound containing composition at a pH where a low viscosity is exhibited and in use the solution is mixed with a more alkaline component in a quality sch that the pH of the resulting mixture is one at which the thickener exhibits an increased viscosity, wherein suitable polymer include polyacrylic acids and copolymer such as Acusol 820 which has little thickening at pH 3 and forms a viscous gel at pH 6 (page 10). Thus the thickening polymer is taught to be placed in the acidic peroxide composition and thicken when mixed with the basic component upon use.
Applicant argues claim 13 and 29 require the viscosity for the post mix composition be greater than 50000 mPa s at standard conditions. The office relies on routine optimization to bridge multiple missing limitations including the claimed extremely high post mix viscosity thresholds as claimed.
In response, the instant claims require the solvent and/or dispersion medium has a viscosity lower than 1000 mPa s and/or wherein the amount of pH induced thickener is sufficient for causing the peroxide compristion to have a viscosity higher than 50000 mPa s. Thus the instant claims do not require the final viscosity, wherein the instant rejection addresses the low starting viscosity.
103: the ‘485 patent (Allred) in view of the ‘023 publication (Smith)
Applicant argues the ‘485 patent teaches polymeric thickeners lose gel performance in concentrated acidic H2O2 and therefore are kept in a water-free base gel, not in the acidic peroxide part. The ‘023 publication likewise teaches placing the pH triggered acrylate thickener on the alkaline side while using cellulose only (not HASE) in the acidic peroxide. Thus the prior art teaches away.
In response, the ‘023 publication teaches the thickener is originally present in an acidic, peroxide compound containing composition at a pH where a low viscosity is exhibited and in use the solution is mixed with a more alkaline component in a quality sch that the pH of the resulting mixture is one at which the thickener exhibits an increased viscosity, wherein suitable polymer include polyacrylic acids and copolymer such as Acusol 820 which has little thickening at pH 3 and forms a viscous gel at pH 6 (page 10). Thus the thickening polymer is taught to be placed in the acidic peroxide composition and thicken when mixed with the basic component upon use. It would have been prima facie obvious to one of ordinary skill in the art before the filing date of the claimed invention to use Acusol 820 as the thickening polymer in the peroxide composition of the dental bleaching composition because the ‘485 patent teaches a two part bleaching composition including a peroxide and alkaline compositions and a thickening polymer and the ‘023 publication teaches Acusol820 used a thickening polymer in a two part peroxide composition and alkaline composition system, thus the ‘485 patent and the ‘023 publication are directed to two part compositions containing thickening polymer, peroxide composition and an alkaline composition. One of ordinary skill in the art would be motivated to include Acusol 820 in the peroxide composition as the ‘485 patent teaches the composition to contain a thickening agent and the ‘023 publication teaches Acusol 820 to be a thickening agent known to be used in a peroxide containing compositions to thicken the composition once combined.
The ‘485 patent, the ‘023 publication, the ‘574 patent and the ‘723 publication:
Applicant argues that claim 17 requires the selectin module explicitly determines and controlled dispenses quantities to meet user specified target composition and to produce an instant gel meeting defined viscosity within a short thickening period. None of the cited reference teaches a controller that compute and drives component ratios to achieve pH and viscosity objective. The ‘574 patent only sets volumes for nanoemulsion and the’723 publication only statically mixes.
In response, the ‘574 patent further teaches that a user interface may be used to control the dispensing device and teaches that the dispensed dose can be tailored to a specific target individual by using the user interface to enter constituent amounts and ratio information (column 3, lines 30-60). It would be obvious to one skilled in the art to use the ‘574 patent user interface in 723 publication’s two component hydrogel dispensing system for administrating the whitening composition taught by the ‘485 patent with a reasonable expectation of administering precise, customized doses of the ‘485 patent whitening composition. Since the ‘574 patent teaches that both the amounts and the ratio of the constituents may be selected using the user interface, it is the Examiner’s position that both the user interface and selection module limitation of claim 14 are inherently taught by the ‘574 patent and one would be motivated to a dual chamber syringe with mixing component and user modified interface as taught by the ‘574 patent and the ‘723 publication to administer the whitening composition of the ‘485 patent as the ‘485 patent teaches a wide range of ratio of components that can be used and would be capable of obtained the desired viscosity.
Conclusion
No claims are allowed.
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.
Examiner Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LYNDSEY MARIE BECKHARDT whose telephone number is (571)270-7676. The examiner can normally be reached Monday-Thursday 9am to 4pm and Friday 9am to 2pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Brian-Yong Kwon can be reached at 571-272-0581. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/LYNDSEY M BECKHARDT/Examiner, Art Unit 1613
/BRIAN-YONG S KWON/Supervisory Patent Examiner, Art Unit 1613