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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 04/02/2026 has been entered.
Applicants’ arguments, filed 04/02/2026, 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 Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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 § 103
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 (i.e., changing from AIA to pre-AIA ) 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.
Claims 1, 10, 11, 14, 16, 18, 21, 25, 27, 29, and 37-38 are rejected under 35 U.S.C. 103 as being unpatentable over Pan et al. (US 2019/0159981) in view of Delfanti et al. (IADR/PER General Session, 2010, ID: 1877).
Regarding instant claims 1, 10, 14, 16 and 37-38, Pan et al. teaches oral care compositions comprising “an orally acceptable vehicle, a peroxide whitening agent, and one or more gelling agents”, wherein one or more gelling agents includes “at least one of palmitic acid, stearic acid, or mixtures thereof” (Abstract).
The reference teaches several specific embodiment its oral care formulations below (p. 6, para. [0053]):
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Note that the excipients include “anticalculus agents”, but none are specifically disclosed here. Pan et al. teaches use of “zinc citrate trihydrate” as an “[i]lustrative anticalculus agent” (see p. 5, para. [0045]). Accordingly, it would have been reasonable or obvious to add zinc citrate trihydrate as the anticalculus agent for the compositions of Table 3. Consequently, incorporation of the soluble zinc salt, zinc citrate trihydrate, would have resulted in the dissociation of zinc ions from citrate, availing themselves of attachment to other ingredients in the formulation, namely the stearic acid, thereby providing a divalent salt of those fatty acids, as per claim 1 and 8, in situ. Additionally, the fatty acids of Pan et al. may be present “from about 1 weight % to about 50 weighty %” (p. 1, para. [0011]). Contacting a tooth surface with the formulations, as per claim 37, are anticipated by the intended use of the reference, as oral care composition.
The prior art is not anticipatory insofar as zinc citrate, which would have provided divalent salts of the fatty acids recited therein, is not required for the practice of the invention: however, it would have been obvious to add it, as anticalculus agent, given its plain enumeration in the prior art. Additionally, Pan does not disclose a specific concentration of zinc ions.
Delfanti measured “zinc concentration and lactate generation in plaque after brushing with toothpaste containing 2% zinc citrate trihydrate (ZCT)” [Objective]. Delfanti found that “2% ZCT toothpaste delivered significant levels of zinc to plaque and reduced food-induced lactate production in plaque” [Conclusion].
It would have been obvious to one of ordinary skill in the art, before the effective filling date of the claimed invention, to have combine the 2% zinc citrate trihydrate of Delfanti with the compositions disclosed by Pan because Delfanti discloses 2% zinc citrate trihydrate delivered significant levels of zinc to plaque. One would have had an expectation of success because Delfanti discloses the zinc citrate trihydrate was delivered by toothpaste. See MPEP 2143, Exemplary Rationale A.
Additionally, a skilled artisan would have understood that the concentration of zinc citrate trihydrate would have affected the total zinc ions available and therefore final amount of zinc ions delivered to the plaque. As such, Delfanti teaches the concentration of zinc citrate trihydrate is a result effective variable. Accordingly, it would have been obvious to a skilled artisan to optimize the amount of zinc citrate trihydrate in composition. "[W]here 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 experimentation" (see MPEP 2144.05 IIA quoting In re Aller, 220 F.2d 454, 456 (105 USPQ 233)).
The molar mass of zinc citrate trihydrate is 628.38 g/mol1 and provides three zinc ions upon disassociation. The molar mass of zinc stearate is 632.33 g/mol2. Therefore:
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Accordingly 2% zinc citrate trihydrate would have provided zinc ions in amounts great enough to result in salts of fatty acids within the instantly claimed range.
Similarly, with respect to the amount of orally acceptable vehicle, 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). In the present case, the instantly claimed amount of orally acceptable vehicle, 5-80 wt. %, overlaps with the amount of the prior art, 24.95 wt. % propylene glycol, and so a prima facie case of obviousness exists.
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filling date of the claimed invention, to have formulated a composition comprising a propylene glycol (orally acceptable carrier) in the presently claimed amounts, a crosslinked PVP complexed with hydrogen peroxide (i.e., hydrogen peroxide source; instant claim 14) and zinc stearate in the presently claimed amounts. Wherein the composition does not comprise water.
Regarding instant claims 11, 18, 21, 25, 27, Pan discloses:
The formulations comprise “block copolymers of ethylene oxide (EO) and propylene oxide (PO)”, e.g. “PLURONIC® P105”, as humectant, which as a molecular weight more than 5000 Da, i.e. about 6500 Da (see USBiological Live Sciences cited by Examiner), as per claim 10-11, where humectants may be present “from 5 weight % to about 60 weight %” (p. 2, para. [0031]).
The whitening agent, e.g., crosslinked PVP with hydrogen peroxide, may be present “from about 8 weight % to about 14 weight %” (p. 3, para. [0034]), as per claim 18.
Fluorides such as “stannous fluoride” “may be greater than 0 weight % and less than 0.8 wt%” (p. 4, para. [0042]), as per claim 21.
The formulations are “substantially free of fatty alcohols” (p. 1, para. [0012]), as per claim 25.
Abrasives, such as, “sodium metaphosphate” shown in Table 3 above, was present at about 24 % based on a total weight of the oral care product, as per claim 27.
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). In the present case, the instantly claimed ranges for peroxide whitening agent (e.g., PVP-hydrogen peroxide), fluoride ion source (stannous fluoride), fatty alcohol and abrasive (sodium metaphosphate) overlap with the respective ranges of the prior art and so a prima facie case of obviousness exists for each range.
Regarding instant claim 29, Pan discloses antioxidants, such as, “butylated hydroxyanisole (BHA)”, as per claim 28, may also be present (p. 5, para. [0046]). The prior art is silent as to the amount antioxidant present in the composition; however, because the presence of antioxidants is taught, it would have been obvious to optimize the range of antioxidants. Accordingly, "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 experimentation." (see MPEP 2144.05, II. A, quoting In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955)).
2) Claim(s) 32, 34, 35 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pan et al. (US 2019/0159981) in view of Delfanti et al. (IADR/PER General Session, 2010, ID: 1877) as applied to claims 1, 10, 11, 14, 16, 18, 21, 25, 27, 29, and 37-38 above, and further in view of Potnis et al. (US 2017/0181942 A1).
Pan et al. and Delfanti, which are taught above, differ from claims 32, 34, 35 insofar as they do not teach any specific surfactants or a pH range for the compositions.
Potnis et al. teaches storage stable tooth whitening compositions (Abstract), comprising surfactants, such as, “sodium lauryl sulfate”, which may be present from “about 0.5 to about 3%” (p. 3, para. [0028]), as per claims 32, 34.
Potnis et al. also teaches use of a buffering agent “sufficient to provide a pH of about 5 to about 9, preferably about 6 to about 8” (p. 2, para. [0019]), as per claim 35.
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).
In this case, it would have been obvious add sodium lauryl sulfate, as surfactant, and a buffer sufficient to provide a pH within the claimed range of about 6 to about 9, based on its suitability for its intended use of oral care tooth whitening formulations, as taught by Potnis et al. The artisan would have had a reasonable expectation of success with the combination insofar as the compositions of Pan et al. comprise surfactants (see Table 3) and pH modifying agents (p. 4, para. [0043).
3) Claims 1, 10, 14, 16, 18, 21, 25, 27, 32, 34, 35 and 37-38 are rejected under 35 U.S.C. 103 as being unpatentable over Potnis et al. (US 2017/0181942 A1).
Potnis discloses an anhydrous composition comprising a tooth whitening inorganic salt of peroxymonosulfate [abstract & 0015]. Additional whitening agents, such as, hydrogen peroxide, as per claims 14 and 16 may also be present [0026]. The composition may further comprise about 10% to about 60% by weight polyethylene glycol (i.e., orally acceptable carrier according to instant claim 10) [0021] and lubricants including, for example, zinc stearate in amounts from 1% to 15% by weight (i.e., instant claims 1, 38-43) [0025]. Potnis also discloses a method comprising applying to composition to the teeth (i.e., instant claim 37) [p. 8, claim 15]. Potnis does not discloses the presence of fatty alcohols (i.e., instant claim 25) and discloses “[t]he solid compositions of the present disclosure contain no water or have a low water content” (i.e., instant claim 38) [0015].
Potnis is not anticipatory because it does not discloses all the claimed elements in one example or embodiment.
However, given the disclosure of each component individually, it would have been prima facie obvious for a person having ordinary skill in the art at, at the time of filling, to have selected and combined known components for their established functions with predictable results by following the teachings of Potnis. MPEP 2143 and 2144.06(I).
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). In the present case, the instantly claimed range of zinc stearate of 3-10 w.t% overlaps with the 1-15 w.t% range of the prior art, and so a prima facie case of obviousness exists. Similarly, the claimed ranges for the orally acceptable vehicle (polyethylene glycol; 5-80% instant claim 10), and water (less than 5%; instant claim 38) overlap with the ranges of the prior art and a prima facie case of obviousness exists.
Therefore, it would have been obvious to one of ordinary skill in the art, at the time of filling, to have formulated a non-aqueous composition comprising an orally acceptable vehicle (polyethylene glycol), a hydrogen peroxide whitening agent, and zinc stearate in the instantly claimed amounts. Wherein the composition does not comprise fatty alcohols and water.
Regarding instant claim 18, the prior art is silent as to the amount of additional whitening agents present in the composition; however, because the presence of additional whitening agent is taught, it would have been obvious to optimize the range of additional whitening agent, as per claim 18. Accordingly, "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 experimentation." (see MPEP 2144.05, II. A, quoting In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955)).
Regarding instant clam 21, Potnis discloses mouthrinse compositions may comprise an anti-cavity agent such as sodium fluoride [0043].
It would have been obvious to one of ordinary skill in the art, before the effective filling date of the claimed invention, to have combined the sodium fluoride with the solid composition of Potnis for the desirable effect of anti-cavity action. One would have had an expectation of success because Potnis discloses sodium fluoride is an anti-cavity agent. See MPEP 2143, Exemplary Rationale A.
Furthermore, the prior art is silent as to the amount of anti-cavity agent present in the composition; however, because the presence of anti-cavity agent is taught, it would have been obvious to optimize the range of anti-cavity agent, as per claim 21. Accordingly, "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 experimentation." (see MPEP 2144.05, II. A, quoting In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955)).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filling date of the claimed invention, to have formulated the composition taught by Potnis, and discussed above, to further comprise sodium fluoride within the instantly claimed amounts.
Regarding instant claims 27, 32, 34 and 35, Potnis discloses drying agents, such as calcium pyrophosphate (i.e., abrasive), may be present in amounts from 0.1% to about 60% by weight of the total composition [0018], as per claim 27.
The composition may also include surfactants [0027]. “Examples of the surfactant that can be used are sodium lauryl sulfate” [0028], wherein “[t]ypical amounts of surfactant are about 0.5% to about 3%” [0028], as per claims 32 and 34.
“The amount of buffering agent is sufficient to provide a pH of about 5 to about 9” [0019], as per claim 35.
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). In the present case, the claimed ranges for the abrasive (calcium pyrophosphate; 5-80% instant claim 10) and pH (6-9) overlap with the ranges of the prior art and a prima facie case of obviousness exists.
Finally, contacting a tooth surface with the formulations, as per claim 37, are anticipated by its intended use, as oral care composition.
4) Claims 11 and 29 are rejected under 35 U.S.C. 103 as being unpatentable over Potnis et al. (US 2017/0181942 A1) as applied to claims 1, 10, 14, 16, 18, 21, 25, 27, 32, 34, 35 and 37-38 above, and in further view of Pan et al. (US 2019/0159981).
Potnis, which is taught above, differs from the instant claims insofar as it does not disclose a copolymer according to instant claim 11 and an antioxidant.
According to Potnis “[i]n some embodiments, the present disclosure also concerns a method for whitening teeth comprising mixing the solid composition described herein into water, a mouthrinse base, or a toothpaste base” [0041].
Pan discloses an oral care composition comprising an orally acceptable vehicle, a peroxide whitening agent and a gelling agent, wherein the composition is a toothpaste [p. 6, claim 1]. Pan discloses suitable orally acceptable vehicles include “block copolymers of ethylene oxide (EO) and propylene oxide (PO)”, e.g. “PLURONIC® P105”, as humectant, which as a molecular weight more than 5000 Da, i.e. about 6500 Da (see USBiological Live Sciences cited by Examiner), as per claim 11, where humectants may be present “from 5 weight % to about 60 weight %” (p. 2, para. [0031]).
It would have been obvious to one of ordinary skill in the art, at the time of filling, to have combined the orally acceptable vehicle taught by Pan in the amounts taught by Pan with the composition taught by Potnis. One would have been motivated to make this combination because Potnis desires a toothpaste base and Pan discloses PLURONIC® P105 is part of a suitable vehicle for toothpastes. One would have had an expectation of success because Pan discloses the PLURONIC® P105 is suitable for oral care compositions comprising a peroxide whitening agent. Additionally, in combining these elements one would have expected nothing more than predictable results because, when combined, each prior art element would have performed the same function as it had separately. See MPEP 2143, Exemplary Rationale A.
Pan also discloses antioxidants, such as, “butylated hydroxyanisole (BHA)”, as per claim 28, may also be present (p. 5, para. [0046]). The prior art is silent as to the amount antioxidant present in the composition; however, because the presence of antioxidants is taught, it would have been obvious to optimize the range of antioxidants. Accordingly, "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 experimentation." (see MPEP 2144.05, II. A, quoting In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955)).
Additionally, it would have been obvious to one of ordinary skill in the art, at the time of filling, to have combined the antioxidants of Pan with the composition taught by Potnis to gain the desirable effects of antioxidants. One would have had an expectation of success because Pan discloses these antioxidants for use in an oral care composition comprising a peroxide whitening agent. See MPEP 2143, Exemplary Rationale A.
Therefore, it would have been obvious to one of ordinary skill in the art, at the time of filling, to formulated the composition taught by Potnis to further comprise block copolymers of ethylene oxide (EO) and propylene oxide (PO) with a molecular weight greater than 5000 Da and an antioxidant within the instantly claimed amounts.
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.
1) Claim 1, 10, 11, 14, 16, 18, 21, 25, 27, 29, 32, 34, 35 and 37-38 stand provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1, 3-5, 7, 13, 14, 16-18, 23, 24, 28, 32-34, 36, 39, 42, and 44 of copending Application No. 18/043703 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because they both claim a nonaqueous (i.e., less than 5wt% water; instant claim 28) oral care composition comprising an orally acceptable vehicle, a whitening agent, and one or more gelling agents which include divalent salts of fatty acids [claim 1; instant claim 1]. They both further claim the fatty acid may be saturated [claim 3; instant claim 3], unsaturated [claim 4; instant claim 4], palmitic acid [claim 5; instant claim 5], calcium palmitate [claim 13; instant claim 8 and 39] and comprise 3-10 wt.% of the total composition [claim 16; instant claim 9]. They both claim the orally acceptable carrier may comprise propylene glycol in amounts of 5-80 wt. % [claim 17; instant claim 10] and may further comprise a copolymer of ethylene oxide and propylene oxide at 5-20 wt% [claim 18; instant claim 11]. They both claim a peroxide whitening agent such as peroxy acids in amounts from 1-10 wt. % [claim 24; instant claim 14, 16 and 17]. They both claim a fluoride ion source such as stannous fluoride in amounts from 0.01-5 wt.% [claim 28; instant claim 21]. They both claim the composition comprises less than 5 wt. % fatty alcohol and water [claims 32 and 33; instant claim 25 and 26]. They claim the same abrasives [claim 34; instant claim 27], antioxidants [claim 36; instant claim 29], surfactants [claim 39; instant claim 32 and 34] and pH [claim 42; instant claim 35]. It would have been obvious to one of ordinary skill in the art, at the time of filling, to have contacted the oral care composition comprising a whitening agent of claims ‘703 to a tooth surface, thereby achieving the instantly claimed method.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
2) Claims 1, 10, 11, 14, 16, 18, 21, 25, 27, 29, 32, 34, 35 and 37-38 stand provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3-5, 7, 10-13, 15, 17, 19, 24, 28, 30, 32, 35, 37, 38 and 39 of copending Application No. 18/043,679., in view of Pan et al. (US 2019/0159981).
The claims of copending Application No. 18/043,679 (‘679) disclose a nonaqueous (i.e., less than 5wt% water; instant claim 38) oral care composition comprising an orally acceptable vehicle, a whitening agent, and one or more gelling agents, wherein the gelling agent comprises a monovalent salt of a fatty acid, wherein the fatty acid is a C12 to C32- fatty acid [claim 1].
Pan discloses oral compositions comprising a whitening agent and a fatty acid gelling agent [abstract]. The examples include “anticalculus agents”, such as “zinc citrate trihydrate” (see [0058]). Accordingly, it would have been reasonable or obvious to add zinc citrate trihydrate as the anticalculus agent for the compositions of claims ‘679. Consequently, incorporation of the soluble zinc salt, zinc citrate trihydrate, would have resulted in the dissociation of zinc ions from citrate, availing themselves of attachment to other ingredients in the formulation, namely the monovalent salts of fatty acids, thereby providing a divalent salt of those fatty acids, as per claim 1 and 8, in situ.
Additionally, the claims of ‘679 and the instant claims disclose overlapping ranges for the amount of gelling agent [claim 10; instant claim 9], the same orally acceptable vehicle [claim 12-13 and 15; instant claims 10 and 11], source of hydrogen peroxide as the whitening agent [claims 17 and 19; instant claims 14, 16 and 18], fluoride ion source [claim 24; instant claim 21], abrasives [claim 30; instant claim 27], antioxidants [claim 32; instant claim 29] surfactants [claim 35 and 37; instant claims 32 and 34] and the same methods [claim 38l; instant claim 37]. The claims of ‘679 also disclose the composition may be free of water [claim 1 and 29] and fatty alcohols [claim 28]. Finally, because the compositions comprise substantially the same components, one of ordinary skill in the art would have expected them to have the same properties, i.e., pH between 6 and 9.
This is a provisional nonstatutory double patenting rejection.
3) Claims 1, 10, 11, 14, 16, 18, 21, 25, 27, 29, 32, 34, 35 and 37-38 stand rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of U.S. Patent No. 11,141,364 in view of Potnis et al. (US 2017/0181942 A1; publication date 06/29/2017) and Pan et al. (US 2019/0159981).
The claims of ‘364 disclose an oral care composition comprising an orally acceptable vehicle, a peroxide whitening agent and a fatty acid gelling agent, such as stearic acid and palmitic acid [claim 1], wherein the composition is anhydrous (i.e., nonaqueous and less than 5wt% water; instant claim 39) [claim 9].
Pan discloses oral compositions comprising a whitening agent and a fatty acid gelling agent [abstract]. The examples include “anticalculus agents”, such as “zinc citrate trihydrate” (see [0058]). Accordingly, it would have been reasonable or obvious to add zinc citrate trihydrate as the anticalculus agent for the compositions of claims ‘364. Consequently, incorporation of the soluble zinc salt, zinc citrate trihydrate, would have resulted in the dissociation of zinc ions from citrate, availing themselves of attachment to other ingredients in the formulation, namely the stearic and palmitic acids, thereby providing a divalent salt of those fatty acids, as per claim 1 and 8, in situ.
Potnis discloses a storage-stable solid (i.e., nonaqueous) composition comprising a tooth whitening agent (i.e., oral care composition) [abstract]. Potnis also discloses the pH of the composition is between 5 and 9 [0019].
It would have been obvious to one of ordinary skill in the art, at the time of filling, to have provided the composition taught above at a pH from 5 to 9 because Potnis discloses 5-9 is a suitable pH range for a nonaqueous oral care composition. See MPEP 2144.07. As a result, the instantly claimed range (pH of 6-9; instant claim 35) lies inside the range of the prior art and so a prima facie case of obviousness exists. It would have been obvious because 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).
Both the claims of ‘364 and the instant claims teach a composition which comprises; 0wt% fatty alcohols [claim 7; instant claim 25], the same sources of hydrogen peroxide [claim 10-12; instant claims 14 and 16]. They also both discloses the same methods of use [claim 13; instant claim 37].
Response to Arguments
1) On page 7 of their Remarks, Applicant argues that Pan is silent regarding divalent salts of fatty acids and “[t]he fact that the Office cited additional art in the Office Action dated 06/03/2025 to present an obviousness case is evidence that Pan itself does not render the present claims obvious.”
This argument is not persuasive. As discussed above, upon the addition of soluble zinc salts, divalent salts of fatty acids would have formed in situ.
2) On page 8 of their Remarks, Applicant argues that “the Office's theory that adding zinc citrate trihydrate as an anticalculus agent would result in "in situ" formation of divalent fatty acid salts as gelling agents is speculative and unsupported.” And that “nothing in Pan would have led one of skill in the art to select zinc citrate trihydrate from the long list of anticalculus agents reported in Pan.”
This argument is not persuasive. The "in situ" formation of divalent salts of fatty acids is a matter of chemistry insofar as salts, in solution, are capable of dissociating and re-associating with other molecules based on electrostatic attraction. This notion is supported by the instant specification at Examples 1 and 4 on pages 20-22, where divalent salts of fatty acids are formed in situ upon the addition of a ZnCl2.
A skilled artisan would have been motivated to selected the zinc citrate trihydrate because Pan discloses it is a suitable anticalculus agent. The prior art’s mere disclosure of more than one alternative does not constitute teaching away from any of these alternative because such disclosure does not criticize, discredit or otherwise discourage the solution. See MPEP 2123. There is nothing directly stated in Pan that would have discredited or discouraged the selection of zinc citrate trihydrate.
3) On page 7 of their Remarks, Applicant argues that “the Office has improperly used the present specification and claims as a template to pick and choose elements of Pan to cobble together its obviousness allegation with no motivation or reasonable expectation of success.” And that “the Office has improperly relied on knowledge gleaned only from applicant's disclosure - the use of zinc chloride and a fatty acid to form a gel – rather than what is reported in Pan. Nothing in Pan teaches or suggests "in situ" formation of divalent salts of fatty acids.”
This argument is not persuasive. In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971). In the present case, Pan would have motivated a skilled artisan to select zinc citrate trihydrate because it was discloses as a suitable anticalculus agent.
The formation of the divalent salt in the presence of free zinc ions is a matter of chemistry insofar as salts, in solution, are capable of dissociating and re-associating with other molecules based on electrostatic attraction. The Examiner only cites the specification as evidence for this notion, not for a suggestion, or motivation to combined the zinc citrate trihydrate with the compositions disclosed by Pan.
4) On page 7 of their Remarks, Applicant argues that “the skilled artisan would not have been motivated to combine the zinc citrate trihydrate and the fatty acid, since it would no longer be a useful anticalculus agent as intended by Pan.”
This argument is not persuasive. A skilled artisan would have been motivated to combine the zinc citrate trihydrate with the compositions disclosed by Pan, which call for anticalculus agents, because Pan discloses zinc citrate trihydrate is a suitable anticalculus agent.
5) On page 8 of their Remarks, Applicant argues that “[t]he number of choices that one of skill in the art would have to make, without guidance, to modify the compositions of Pan to arrive at the recited compositions, are such that the resulting composition would not be obvious to one of skill in the art.”
This argument is not persuasive. A skilled artisan would have been motivated by Pan for each choice cited by applicant: (1) selecting anticalculus agent, (2) choosing zinc citrate trihydrate and (3) choosing the appropriate amount of zinc citrate trihydrate. A skilled artisan would have been motivated to select an anticalculus agent for its desirable affects in preventing tartar. One would have been motivated to select zinc citrate trihydrate because Pan discloses it is a suitable anticalculus agent. And a skilled artisan would have been motivated to selected the appropriate amount of zin citrate trihydrate in view of Delfanti, as discussed above.
Additionally, the prior art’s mere disclosure of more than one alternative (i.e., alternatives to anticalculus agents, and alternatives to zinc citrate trihydrate) does not constitute teaching away from any of these alternative because such disclosure does not criticize, discredit or otherwise discourage the solution. See MPEP 2123. There is nothing directly stated in Pan would have discredited or discouraged the solution as claimed therefore this argument has not been found persuasive.
6) On page 8 and later on page 10 of their Remarks, Applicant argues that zinc stearate provides unexpected peroxide stability. Applicant cites Examples 2-4 on pages 21-22 of the instant specification for support.
This argument is not persuasive. Overcoming a rejection based on unexpected results requires the combination of three different elements: (i) the results must fairly compare with the prior art, (ii) the results must truly be unexpected and (iii) the claims must be commensurate in scope. MPEP §716.02. The burden rests with Applicant to establish results are unexpected and significant. MPEP §716.02(b). Applicant's showing of allegedly unexpected results does not satisfy any of these requirements.
(i) In the present case the results have not been compared to the closest prior art. The closest prior art is disclosed by Pan at Table 3 on page 6. See MPEP 716.02(e).
(ii) 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) (MPEP 716.02(b)). In the present case it does not appear that the results are truly unexpected in view of Pan. Pan discloses fatty acids increase peroxide stability: "The present inventors have also surprisingly and unexpectedly discovered a method for increasing peroxide stability in a single phase oral care product and / or a single phase oral care composition thereof. The method for increasing peroxide stability may include replacing conventional thickening agents with fatty acids" [0026]. Furthermore, Pan welcomes the addition of compounds that act as ion sources (see, for example, [0041] and [0045]). Thus, a skilled artisan would have expected salts of fatty acids to provide similar stability to peroxide whitening agents and similar gelling properties to the composition.
(iii) Finally, the "objective evidence of nonobviousness must be commensurate in scope with the claims which the evidence is offered to support" (see MPEP 716.02(d) quoting In re Clemens, 622 F.2d 1029, 1036, 206 USPQ 289,296 (CCPA 1980)). In the present case, the claims are not commensurate in scope with the evidence. For example, the claims recite "an orally acceptable carrier" which includes solid carriers while the evidence only discloses compositions comprising propylene glycol and copolymer of ethylene oxide and propylene glycol as the carrier.
7) On pages 10 of their Remarks, Applicant rejection over Potnis should be withdrawn “because Potnis does not teach or suggest divalent salts of fatty acids as gelling agents.” And that a “person of ordinary skill in the art would not look to tablet lubricants to serve as gelling agents in a nonaqueous oral care composition such as a toothpaste.”
This argument is not persuasive. “Products of identical chemical composition can not have mutually exclusive properties.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. See MPEP 2112.01 (II).
The composition taught by Potnis reads on the claimed composition, regardless of the function of the divalent salts of fatty acids. That is to say, even though the Potnis discloses the divalent salts of fatty acids for a different purpose, Potnis nevertheless disclose every claimed element, including the divalent salts of fatty acids and teaches they may be combined to form a nonaqueous composition, as discussed above. As such a skilled artisan is not looking to a tablet lubricant to serve as a gelling agent. Rather, the zinc stearate reads on the instantly claimed gelling agents because they are present in a composition which reads on the instantly claimed composition.
8) Applicant argues the cited secondary references do not cure the deficiencies of the primary references. Namely, Applicant argues that Potnis does not cure the deficiencies of Pan (i.e., pH and presence surfactants), and Pan does not cure the deficiencies of Potnis (i.e., presence of the claimed humectant).
The Examiner disagrees for the reasons above and of record.
9) On pages 11-12 of their Remarks, Applicant requests the double patenting rejections be withdrawn.
The conflicting claims continue to read on the instant claims. The instant claims stand rejected over the conflicting claims for the reasons above and of record.
Technological Background
The prior art made of record is considered pertinent to applicant's disclosure.
1. PubChem Compound Summary for CID 71587583, Zinc citrate trihydrate. Retrieved April 8, 2026 from https://pubchem.ncbi.nlm.nih.gov/compound/Zinc-citrate-trihydrate, which is pertinent for teaching the molar mass of zinc citrate trihydrate.
2. PubChem Compound Summary for CID 11178, Zinc Stearate. Retrieved April 8, 2026 from https://pubchem.ncbi.nlm.nih.gov/compound/Zinc-Stearate, which is pertinent for teaching the molar mass of zinc stearate.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to COLMAN WELLES whose telephone number is (571)272-3843. The examiner can normally be reached Monday - Friday, 8:30am - 5:00pm ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sahana Kaup can be reached at (571)272-6897. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/C.T.W./Examiner, Art Unit 1612
/WALTER E WEBB/Primary Examiner, Art Unit 1612
1 PubChem Compound Summary for CID 71587583, Zinc citrate trihydrate. Retrieved April 8, 2026 from https://pubchem.ncbi.nlm.nih.gov/compound/Zinc-citrate-trihydrate.
2 PubChem Compound Summary for CID 11178, Zinc Stearate. Retrieved April 8, 2026 from https://pubchem.ncbi.nlm.nih.gov/compound/Zinc-Stearate.
Prosecution Insights