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 .
Response to Arguments
Applicant’s arguments filed 3/6/2026 have been fully considered but they are not persuasive.
The 112(b) rejection of claim 46 is withdrawn as the issues identified in the previous office action have been resolved.
The 103 rejections of claims 34-46 and 48-52 are maintained.
The 103 rejection of claim 47 is withdrawn as claim 47 has been cancelled.
In light of the claims as amended, all non-statutory double patenting rejections have been modified or withdrawn and new rejections presented.
103 Rejection over Dolan
Applicant argues that Dolan fails to provide any teaching, suggestion, or motivation to selected the claimed thickening agents as part of a thickening system that has any stabilizing effect on hydrogen peroxide. This is not persuasive. Dolan teaches xanthan gum [0113], silica thickeners [0116], and PVP [0115] as suitable thickening agents, and further teaches the addition of an alkyl alcohol [0074, 0112], such as cetyl alcohol [0077], for purposes of increasing viscosity of the composition [0074] (reads on thickening agent). A “laundry list” of suitable alternatives in the prior art can be sufficient to motivate the selection of those alternatives where the list gives a person of ordinary skill a finite set of predictable choices for solving the same problem (see MPEP 2143 - obviousness rationale; “obvious to try” and predictable success). Here, the listed thickening agents are provided for the purpose of thickening the composition and a skilled artisan could expect to combine those thickening agents with a reasonable expectation of success. Additionally, combining equivalents known for the same purpose is prima facie obvious. “It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980). MPEP 2144.06.
The assertion that Dolan provides no teaching, suggestion, or motivation for the selection of a set of thickening agents for the specific purpose of achieving a stabilizing effect on hydrogen peroxide is immaterial because it is not necessary that the prior art suggest the combination to achieve the same advantage or result discovered by applicant. See, e.g., In re Kahn, 441 F.3d 977, 987, 78 USPQ2d 1329, 1336 (Fed. Cir. 2006). MPEP 2144 IV. Additionally, a chemical composition and its properties are inseparable. If the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. Thus, if the prior art suggests the instantly claimed combination of thickening agents, then the prior art composition would necessarily be capable of stabilizing hydrogen peroxide. Furthermore, the fact that the inventor has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious. See Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985).
Applicant’s argument regarding the unexpected effect of the claimed composition is also not persuasive. An applicant bears the burden of proving unexpectedly good results. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). When unexpected results are used as evidence of non-obviousness, the results must be shown to be unexpected compared with the closest prior art. In re Baxter Travenol Labs, 952 F.2d 388, 392, 21 USPQ2d 1281, 1285 (Fed. Cir. 1991); In re De Blauwe, 736 F.2d 699, 705, 222 USPQ 191, 196, (Fed. Cir. 1984). Applicant cites that Dolan relies on abrasive purity rather than thickener synergy to achieve stability, but this is not persuasive and fails to demonstrate that the instantly claimed combination of thickeners yielded unexpected results compared to Dolan. In order for the comparison to be valid, the closest prior art and the claimed invention must be tested under substantially the same conditions, and test results must include results of the test performed on the invention as claimed an on the closest prior art. An analysis of the test results should include an explanation of why the results are significant and unexpected. Applicant has not provided this information, and conclusory statements without a showing of actual results of the test performed on the prior art and the claimed invention are insufficient.
Applicant also points to data presented in their instant specification at Example 5 and Table 6 as evidence of unexpected results. This is not persuasive as the data is not commensurate in scope with the instant claims, as very specific compositions and ingredients were tested and Applicant has not established a trend in the exemplified data. There also lacks a nexus between the data presented and the instant invention. None of the example compositions shown in Table 6 are indicated to contain cetyl alcohol or crosslinked PVP (see Table 5), and the tested compositions comprise many additional ingredients not required by the instant claims.
103 Rejection over Dolan in view of Chopra
Applicant argues that a skilled artisan, using Dolan and Chopra, would not be motivated to make the modifications necessary to address hydrogen peroxide stability. Applicant contends that neither Dolan nor Chopra teaches or suggests that the specific combination of thickeners has any effect on the stability of hydrogen peroxide. As discussed above, this is not persuasive because it is not necessary that the prior art suggest the combination to achieve the same advantage or result discovered by applicant. MPEP 2144 IV. The fact that the inventor has recognized another advantage which would flow naturally from following the suggestion of the prior art also cannot be the basis for patentability when the differences would otherwise be obvious. See Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985). (Additional reasons why it would be obvious to select the specific combination of thickeners have been discussed above and will not be repeated herein.) Applicant also states “[a]s in Dolan, Chopra only list xanthan gum, and does not discuss cetyl alcohol at all.” However, Dolan, as discussed above, teaches xanthan gum [0113], silica thickeners [0116], and PVP [0115] as suitable thickening agents, and further teaches the addition of an alkyl alcohol [0074, 0112], such as cetyl alcohol [0077], for purposes of increasing viscosity of the composition [0074]. Chopra teaches xanthan gum, fumed silica, and various ingredients such as carboxyvinyl polymers, polyethylene glycol, carrageenans, cellulose derivatives, and other natural gums, to be suitable thickeners [0060]. Chopra also teaches crosslinked PVP that is not complexed with hydrogen peroxide [0050]. Chopra does not explicitly designate crosslinked PVP to be a thickener, but nonetheless cPVP will have thickening properties because a composition and its properties are inseparable.
103 Rejection over Dolan in view of Labib
Examiner would like note that the Examiner’s interpretation of claim 44 in the previous Office Action as “calcium pyrophosphate comprising about 60 wt% or more of the oral care composition” is not incompatible with the claim as written. There is nothing in the claims that precludes calcium pyrophosphate from being the only abrasive present in the oral care composition. As seen in the rejection below, the Examiner makes obvious using calcium pyrophosphate (i.e. a single abrasive), thus, if calcium pyrophosphate is about 60% of the oral care composition, but is the only abrasive presented (i.e. comprises 100% of the total abrasive in the composition), it reads on the instant limitation of “about 60% or more of the total amount of abrasive in the oral care composition.”
Applicant contends that increasing the amount of calcium pyrophosphate taught in Dolan’s oral care composition to Labib’s amount would render Dolan inoperable for its intended purpose. Applicant points to paragraph [0043] of Dolan as evidence that the composition of Dolan must comprise low amounts of calcium pyrophosphate. This is not persuasive. Dolan states, “suitable sources of abrasives, such as calcium pyrophosphate, can comprise less than about 0.001 % ...” [0043] Examiner interprets this language as reciting calcium pyrophosphate merely as a suitable example of abrasive, and not that calcium pyrophosphate, specifically, is required to be present in the composition at the amounts listed at [0043]. Rather, the relevant teaching is that high amounts of soluble metal ions are less compatible with peroxide due to reactivity between the peroxide and metal ions, specifically trace metal ions such as Cr, Mn, Fe, Co, Ni, Cu, and Mo [0043]. Thus, the takeaway from [0043] is that amounts of abrasives that have high amounts of the recited metal ions should be limited (see also Dolan Table 1 and claim 34). Furthermore, claim 7 of Dolan recites that the composition comprises “from about 1% to about 30% by weight of the oral care composition, of the calcium pyrophosphate.” Thus, increasing the amounts of calcium pyrophosphate to amounts taught by Labib would not render Dolan inoperable for its intended purpose, since Dolan claims a composition comprising calcium pyrophosphate in amount that overlaps with the amount taught by Labib.
103 Rejection over Dolan in view of Zaidel
Applicant argues that Zaidel fails to rectify the deficiencies of Dolan and that the additional features of claim 48 are neither taught nor suggested by the cited art. This is not persuasive. Claim 48 recites potassium nitrate in the amount of about 0.1% to about 9% by weight. Dolan teaches that a desensitizing agent may be included in its whitening composition [0128], and Zaidel teaches the use of potassium nitrate as a desensitizing agent for the reduction of sensitivity and irritation resulting from application of a tooth-whitening composition [0049]. It would be obvious to a skilled artisan to follow the explicit suggestion of Dolan to include a desensitizer, such as potassium nitrate as taught by Zaidel, in its whitening composition, since reduction of sensitivity and irritation is a desirable property. Zaidel also teaches potassium nitrate in the amount of about 3% to about 6% by weight, which falls within the instantly claimed range of about 0.1% to about 9% by weight, and is therefore prima facie obvious.
Double Patenting Rejections over Application No. 18/109,223
Applicant argues that the claims are patentably distinct because the copending claims do not recite xanthan gum or cetyl alcohol. This is not persuasive. The copending claims recite a thickening system comprising cPVP and fumed silica. "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980). Thus, the inclusion of additional suitable thickeners such as xanthan gum or cetyl alcohol would be prima facie obvious. Applicant also argues that the low water concentration of reference Application ‘223 renders the claims patentably distinct. This is not persuasive as claim 1 of Application ‘223 permits for up to 53% water by weight of the composition, and claim 16 permits for up to 41.29% water by weight of the composition, which overlaps with the instantly claimed amount of water. Applicant contends that the Examiner’s misinterpretation of claim 44 renders the rejection of claim 44 moot. As discussed, there is nothing in the claims that precludes calcium pyrophosphate from being the sole abrasive in the composition.
Double Patenting Rejections over Application No. 19/155,982
Applicant argues that the claims are patentably distinct because the copending claims do not recite xanthan gum or cetyl alcohol. This is not persuasive. The copending claims recite a thickening system comprising cPVP and fumed silica. "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980). Thus, the inclusion of additional suitable thickeners such as xanthan gum or cetyl alcohol would be prima facie obvious. Applicant also argues that the low water concentration of reference Application ‘982 renders the claims patentably distinct. This is not persuasive as claim 1 of Application ‘982 permits for up to 45% water by weight of the composition, and claim 16 permits for up to 39.3% % water by weight of the composition. The instant specification defines “about” to be within a range of 10% of a number, therefore both values overlap with the instantly claimed range of about 40% to 90% water. Applicant contends that the Examiner’s misinterpretation of claim 44 renders the rejection of claim 44 moot. As discussed, there is nothing in the claims that precludes calcium pyrophosphate from being the sole abrasive in the composition.
Double Patenting Rejections over Application No. 18/544,959
Applicant argues that the claims are patentably distinct because the copending claims do not recite the requisite thickening system, nor does Application ‘959 it recitecetyl alcohol as a thickening agent. This is not persuasive. As discussed, the inclusion of a suitable thickeners that are known in the art, such as xanthan gum and cPVP, would be prima facie obvious. Additionally, the fact that cetyl alcohol is not taught as a thickener is immaterial. A composition and its properties are inseparable. If the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present.
Maintained Claim Objections
Claim 44 is objected to because of the following informalities: “wherein insoluble phosphate salt” should read “wherein the insoluble phosphate salt”.
Appropriate correction is required.
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.
Maintained/Modified § 103 Rejections
Claim(s) 34-43, 45-47, and 49-53 are rejected under 35 U.S.C. 103 as being unpatentable over Dolan et al. (US 2022/0265531 A1, published on 8/22/2022, filed on 1/18/2022, cited on the 12/19/2023 IDS.)
Regarding claim 34, Dolan teaches an oral care composition comprising a peroxide [claim 1]; crosslinked polyvinyl pyrrolidone (cPVP) [claim 2]; calcium pyrophosphate (reads on abrasive) [claim 1]; and water [claim 1]. Dolan further teaches that the composition may contain cetyl alcohol [claim 32]; from about 5% to about 75% of water by weight of the oral care composition [claim 6]; and a pH of about 4 to about 8 [0082]. The amount of water taught by Dolan overlaps with the instantly claimed range. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976). The claims of the present application also do not exclude that the cPVP could be complexed with hydrogen peroxide. Therefore, cPVP complexed with hydrogen peroxide (cPVP-H2O2) is considered to read upon cPVP. Since Dolan teaches the use of one or more peroxides [0034], a combination of a suitable peroxides, such as hydrogen peroxide and cPVP-H2O2, is prima facie obvious.
Regarding claims 35-36 and 51, Dolan teaches the that peroxide in the oral care composition can comprise hydrogen peroxide [claim 2]. Dolan teaches that the peroxide may be non-complexed [0035]. Dolan teaches that the peroxide can comprise from about 0.01% to about 10% by weight of the oral care composition [0037].
Regarding claims 37 and 38, Dolan teaches that oral care composition can comprise one or more thickening agents, including xanthan gum [0113]. Dolan also teaches that the thickening agent can comprise from 0.1% to about 10% of one or more thickening agents [0117]. It would be obvious to use xanthan gum, a disclosed thickening agent, in an amount that thickening agents are taught to be suitable in.
Regarding claim 39, Dolan teaches that the oral care composition can comprise cetyl alcohol [claim 31] and an alkyl sulfate surfactant [claim 23].
Regarding claim 40, Dolan teaches that the oral care composition can comprise from 0.1% to about 10% by weight of one or more thickening agents which includes xanthan gum and silica thickeners [0116-0117]. This overlaps with the instant claimed range and is prima facie obvious.
Regarding claim 41, Dolan teaches that the oral care composition can comprise a thickening agent comprising fumed silica [0116].
Regarding claim 42, Dolan teaches that the oral care composition can comprise a thickening agent comprising a silica thickener [0116]. Dolan also teaches that the thickening agent can comprise from 0.1% to about 10% by weight of one or more thickening agents [0117]. It would be obvious to use silica thickener, a disclosed thickening agent, in an amount that thickening agents are taught to be suitable in.
Regarding claim 43, Dolan teaches that the oral care composition can comprise from about 0.01% to about 20% by weight of peroxide [0037]. Dolan further teaches that suitable peroxide can comprise of cPVP-H2O2 complex [0034]. As previously discussed, cPVP complexed with hydrogen peroxide (cPVP-H2O2) is considered to read upon cPVP. Therefore, it would be obvious to use cPVP in the amount of 0.01 to about 20% by weight as this overlaps with the instantly claimed range.
Regarding claim 45, Dolan teaches that the oral care composition can comprise one or more humectants each in the amount of about 5% to about 50% by weight of the oral care composition [0111]. This overlaps with the instantly claimed range and is prima facie obvious.
Regarding claim 46, Dolan teaches that the oral care composition can comprise one or more suitable humectants, including polyethylene glycol, glycerin, xylitol, sorbitol, mannitol, and/or mixtures thereof. These serve to add body or “mouth texture” to the composition thus their inclusion is prima facie obvious for the stated purpose [0111].
Regarding claims 49 and 50, these claims recite properties of the claimed composition. Since Dolan makes obvious the claimed composition, and a composition and its properties are inseparable, the claimed properties are presumed to be inherent. When a claimed composition and prior art products are substantially identical, claimed properties are presumed to be inherent. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. See MPEP 2112.01.
Regarding claim 52, Dolan teaches an oral care composition comprising a peroxide [claim 1]; crosslinked polyvinyl pyrrolidone (cPVP) [claim 2]; calcium pyrophosphate [Dolan claim 1]; and water [claim 1]. Dolan further teaches that the oral care composition may comprise of one or more thickening agents such as silica thickener [0116] or xanthan gum [0113]; from about 5% to about 50% of humectant [0111]; from about 5% to about 75% water by weight of the composition [0062]; and a pH of about 4 to about 8 [0082]. Since Dolan teaches the use of one or more thickening agents such as silica and xanthan gum, the use of a combination of these two thickening agents is prima facie obvious.
Regarding claim 53, Dolan teaches an oral care composition comprising a peroxide [Dolan claim 1]; crosslinked polyvinyl pyrrolidone (cPVP) [claim 2]; calcium pyrophosphate [claim 1]; and water [claim 1]. Dolan further teaches that the oral care composition may comprise of one or more thickening agents such as silica thickener [0116] or cetyl alcohol [Dolan claim 32]; an anionic sulfate-based surfactant [claim 23]; about 5% to about 50% of humectant by weight of the oral care composition [0111]; about 5% to about 75% of water by weight of the oral care composition [ claim 6]; and a pH of about 4 to about 8 [0082]. As discussed, Dolan makes obvious the use of silica thickeners and cetyl alcohol. While Dolan doesn’t explicitly teach cetyl alcohol to be a thickening agent, a compound and its properties are inseparable and thus the limitations of the claim have been met.
Claims 34 and 43 are rejected under 35 U.S.C. 103 as being unpatentable over Dolan (previously cited) as applied to claim 34 above, and further in view of Chopra et al. (US 2013/0287710 A1, published on 10/31/2013).
As discussed, Dolan makes obvious the limitations of claims 34-43, 45-47, and 49-53. However, Dolan does not explicitly teach cPVP in an amount from about 0.5% go about 20% by weight of the oral care composition as recited in instant claim 43.
Regarding claim 43, Chopra teaches an oral care composition comprising a cPVP complexed with hydrogen peroxide, abrasive, and an additional, stabilizing amount of (uncomplexed) cPVP [0008]. Chopra further teaches that the additional, stabilizing amount of cPVP comprises from about 1% to about 20% by weight of the composition [0050]. This overlaps with the instant claimed range of 0.5% to about 20% of cPVP by weight, and is prima facie obvious. MPEP 2144.05. It would have been obvious to a person having ordinary skill in the art, before the effective filing date of the claimed invention, to modify the teachings of Dolan with those of Chopra to include stabilizing cPVP in the amount of about 0.5% to about 20% by weight of the oral care composition, to improve the stability of the oral care composition, based on its art recognized suitability for use in oral care compositions. It is prima facie obvious to select a known material based on its suitability for its intended purpose (MPEP 2144.07).
Claims 34 and 44 are rejected under 35 U.S.C. 103 as being unpatentable over Dolan (previously cited) as applied to claim 34 above, and further in view of Labib et al. (US 2021/0121386 A1, published on 4/29/2021).
As discussed, Dolan makes obvious the limitations of claims 34-43, 45-47, and 49-53. However, Dolan does not explicitly teach the limitations of instant claim 44.
Regarding claim 44, Labib teaches that abrasives, such as calcium pyrophosphate [0077], may be included in dentifrices in the amounts of between 7% and 90% by weight [0074].. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the limitations of the reference claims with the teachings of Labib to use calcium pyrophosphate as the abrasive of Dolan in the amount 60% or more in order to alter the abrasivity and consistency of the oral care composition.
Claims 34 and 48 are rejected under 35 U.S.C. 103 as being unpatentable over Dolan (previously cited) as applied to claims 34 above, and further in view of Zaidel et al. (US 2005/0163729 A1, published 7/28/2005, cited on the 6/18/2024 IDS).
As discussed, Dolan makes obvious the limitations of claims 34-43, 45-47, and 49-53. However, Dolan does not explicitly teach potassium nitate in the amount of about 0.1% to about 9% by weight as recited in claim 48.
Regarding claim 48, Dolan teaches that a desensitizing agent may be added to the oral care composition [0128]. Dolan does not explicitly teach an oral care composition further comprising potassium nitrate in an amount of about 0.1% to about 9% by weight of the oral care composition. Zaidel teaches that an oral care composition may be formulated to contain desensitizing agents, including potassium nitrate, to reduce tissue sensitivity and irritation upon application of a tooth-whitening composition [0049]. Zaidel further teaches that potassium nitrate may be present in the amount of about 3% by 6% by weight of the oral care composition [0050]. 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). Therefore, it would have been obvious to a person having ordinary skill in the art, before the effective filing date of the claimed invention, to modify the teachings of Dolan to include potassium nitrate in the amounts taught by Zaidel in an oral care composition containing a whitening agent, in order to reduce sensitivity and irritation. Furthermore, "a prior art reference that discloses a range encompassing a somewhat narrower claimed range is sufficient to establish a prima facie case of obviousness." In re Peterson, 315 F.3d 1325, 1330, 65 USPQ2d 1379, 1382-83 (Fed. Cir. 2003) (see MPEP 2144.005). Here, the range taught by Zaidel encompasses a range narrower than the claimed range of about 0.1% to about 9% potassium nitrate by weight of the oral care composition. Thus, the instant claimed range is prima facie obvious.
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 filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual 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/apply/applying-online/eterminal-disclaimer.
Claims 34-38, 40-46, 51-52 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4, 6, 7, 9, 12 and 16 of copending Application No. 18/109,223 (reference application ‘223) in view of Dolan (previously cited).
Although the claims at issue are not identical, they are not patentably distinct from each other because both disclose oral care compositions comprising a peroxide (hydrogen peroxide); a thickening system of cPVP and silica (fumed silica); calcium pyrophosphate abrasive; water; and a pH of 5.5-7.5.
Regarding claims 34-35 and 37-38, ‘223 teaches hydrogen peroxide [claims 1, 16], cPVP [claim 16], fumed silica [claims 1, 16], calcium pyrophosphate [claims 1, 16], and a pH of 5.5-7.5 [claim 1] The composition of ‘223 may comprise up to 53% water [‘223 claim 1] (100 - 1 - 5 - 35 - 5 - 3 - 1 = 53). ‘223 does not explicitly teach xanthan gum or cetyl alcohol, however Dolan teaches xanthan gum [0113], silica thickeners [0116], and PVP [0115] as suitable thickening agents, and further teaches the addition of an alkyl alcohol [0074, 0112], such as cetyl alcohol [0077], for purposes of increasing viscosity of the composition [0074] (reads on thickener). Combining equivalents known for the same purpose is prima facie obvious. Dolan also teaches that the thickening agent can comprise from 0.1% to about 10% of one or more thickening agents [0117]. It would be obvious to use xanthan gum, thickening agent, in an amount that thickening agents are taught to be suitable in.
Regarding claims 36 and 51, ‘223 teaches hydrogen peroxide in the amount of 1% to 10% by weight [claim 1] and 1% to 6% by weight [claim 4], wherein the composition is not formulated using a PVP-H2O2 complex [claim 6].
Regarding claims 40-43, ‘223 teaches a thickening system comprising cPVP in the amount of 6% to 18% by weight and fumed silica in the amount of 3% to 4% by weight [claim 16].
Regarding claim 44, ‘223 teaches compositions comprising calcium pyrophosphate [claim 1, 16]. ‘223 implicitly teaches that calcium pyrophosphate may be the only abrasive (i.e. 100% of the total amount of the abrasive) in the composition (“one or more” in claim 1).
Regarding claims 45-46, ‘223 teaches an oral care composition comprising 35-75% of propylene glycol by weight [claim 1], further disclosing a composition wherein propylene glycol is used as a humectant [claim 9]. Propylene glycol is also taught in claim 7 in amounts that overlap with the instantly claimed range. ‘223 also teaches 5% to 20% by weight of polyethylene glycol/polypropylene glycol random copolymer [claim 12] (reads on PPG and PEG in instant claim 46).
Regarding claim 52, this claim recites limitations that have already been made obvious in the above rejections of claims 34 and 45-46.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 34-38, 40-46, and 51-52 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 9, 10-11, 14-16, and 20-22 of copending Application No. 19/155,982 (reference application ‘982), in view of Dolan (previously cited).
Although the claims at issue are not identical, they are not patentably distinct from each other because both disclose oral care compositions comprising peroxide (hydrogen peroxide); a thickening system comprising silica and cPVP; calcium pyrophosphate abrasive; water; and pH of about 5.5 to about 7.
Regarding claims 34-35 and 37-38, ‘982 teaches hydrogen peroxide [claims 1, 2, 16], silica thickener [claims 1, 16], calcium pyrophosphate [claims 1, 16], and a pH of about 5.5 to about 7 [claim 3]. The composition of ‘982 may comprise up to 45% water [claim 1]. ‘982 does not explicitly teach xanthan gum or cetyl alcohol, however Dolan teaches xanthan gum [0113], silica thickeners [0116], and PVP [0115] as suitable thickening agents, and further teaches the addition of an alkyl alcohol [0074, 0112], such as cetyl alcohol [0077], for purposes of increasing viscosity of the composition [0074] (reads on thickener). Combining equivalents known for the same purpose is prima facie obvious. Dolan also teaches that the thickening agent can comprise from 0.1% to about 10% of one or more thickening agents [0117]. It would be obvious to use xanthan gum, a thickening agent, in an amount that thickening agents are taught to be suitable in.
Regarding claims 36 and 51, reference application ‘982 teaches an oral care composition comprising hydrogen peroxide in the amount of 1% to 10% hydrogen peroxide by weight [claim 1], wherein the composition is not formulated using a PVP-H2O2 complex [claim 6].
Regarding claims 40-43, reference application ‘982 teaches a thickening system comprising from about 6% to 18% by weight of cPVP [claim 16], about 2 to about 4% by weight of thickening silica [claim 1]. ‘982 further teaches fumed silica [claim 16].
Regarding claim 44, ‘982 teaches compositions comprising calcium pyrophosphate [claim 1, 16]. ‘982 implicitly teaches that calcium pyrophosphate may be the only abrasive (i.e. 100% of the total amount of the abrasive) in the composition as it is the only abrasive component recited in claims 1 and 16.
Regarding claims 45 and 46, reference application ‘982 teaches propylene glycol to be a humectant in the amount of 45 – 70% by weight [claims 7, 9]. Propylene glycol is also taught in claims 1 and 16 in amounts that overlap with the instantly claimed range. ‘892 also teaches 5% to 20% by weight of polyethylene glycol/polypropylene glycol random copolymer [claim 12] (reads on PPG and PEG in instant claim 46).
Regarding claim 52, this claim recites limitations that have already been made obvious in the above rejections of claims 34 and 45-46.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 34-39, 40, 45-46, 48, 51 and 53 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7, 10-11, 14-17, 20, and 24-25 of copending Application No. 18/544,959 (reference application ‘959) in view of Dolan (previously cited), and further in view of Kim et al. (US 2021/0236400 A1, published 8/5/2021).
Although the claims at issue are not identical, they are not patentably distinct from each other because both disclose oral care compositions comprising peroxide; a thickening system comprising silica and polysaccharide; calcium pyrophosphate abrasive; water; and cetyl alcohol.
Regarding claims 34-35, 37-38, and 40, ‘959 teaches about 2% to 10% peroxide [claims 1-3, 24-25], silica thickener [claims 15, 17, 25], calcium pyrophosphate abrasive [claims 20, 24-25], water in about 45% or more [claim 1] (water is also recited in amounts overlapping with the instant claims in claims 5, 24-25), and cetyl alcohol [claim 21]. ‘959 does not explicitly teach xanthan gum, however Dolan teaches xanthan gum [0113] as a suitable thickening agent. Combining equivalents known for the same purpose is prima facie obvious. ‘959 teaches thickening agents in the amount of from about 0.1% to about 10% [claim 14]. It would be obvious to use xanthan gum, a thickening agent, in an amount that thickening agents are taught to be suitable in. ‘959 teaches PVP as a thickening agent but does not explicitly specify whether the PVP is cross-linked. Kim teaches that PVP and cPVP and suitable substitutes to be used as thickeners in toothpaste compositions [0046]. Thus, it would be obvious to include cPVP in the composition of ‘959 as substituting equivalents known for the same purpose is prima facie obvious. MPEP 2144.06. ‘959 does not explicitly indicate the pH of its composition, however a composition and its chemical properties are inseparable, thus if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. Furthermore, Dolan teaches the inclusion of buffering [0122] and pH control agents [0128]. One of ordinary skill in the art would be armed with the knowledge to adjust the pH of the composition as needed.
Regarding claims 36 and 51, ‘959 teaches peroxide wherein peroxide is may be hydrogen peroxide or a PVP-complexed hydrogen peroxide [claim 2]. The deliberate inclusion of both hydrogen peroxide and PVP-complexed hydrogen peroxide in the claim language implicitly indicates “hydrogen peroxide” to be non-complexed.
Regarding claim 39, ‘959 teaches an oral care composition comprising cetyl alcohol [claim 21], and an alkyl sulfate surfactant (sodium lauryl sulfate) [claim 7].
Regarding claims 45-46, ‘959 teaches polyol humectants such as sorbitol, glycerin, inositol, propylene glycol, PPG, and PEG [claims 10 and 11].
Regarding claim 48, ‘959 teaches potassium nitrate in an amount of about 5% or more by weight [claim 1]. ‘959 further teaches potassium nitrate in an amount of about 5% to about 15% by weight [‘959 claim 4].
Regarding claim 52, this claim recites limitations that have already been made obvious in the above rejections of claims 34 and 45-46.
Regarding claim 53, ‘959 teaches a humectant in the amount of about 1% to about 50% [claims 10 and 11] and anionic sulfate-based surfactant [claims 6 and 7].
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
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.
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/AMANDA LYNN CHI/Examiner, Art Unit 1613
/JENNIFER A BERRIOS/ Primary Examiner, Art Unit 1613
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