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 .
Applicants’ arguments, filed 07/16/2026, have been fully considered. Rejections and/or objections not reiterated from previous office action are hereby withdrawn.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 – New by Amendment
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.
1) Claims 1, 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, 11, 14, 16, 18, 21, 27 and 37, 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 38, 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]). The formulations comprise propylene glycol and “block copolymers of ethylene oxide (EO) and propylene oxide (PO)”, e.g. “PLURONIC® P105” which as a molecular weight more than 5000 Da, i.e. about 6500 Da (see USBiological Live Sciences cited by Examiner; instant claim 11), as humectants which may be present “from 5 weight % to about 60 weight %” (p. 2, para. [0031]). 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. 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 claims 1 and 27. According to Pan the source of hydrogen peroxide, i.e., crosslinked PVP hydrogen peroxide as per instant claim 16 according to Examples 4-6 of Pan discussed herein, “may be present in an amount of from about 1 weight % […] to about 17 weight %” (i.e., instant claim 18) [0034]. 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 combined 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.
Finally, 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 amounts of propylene glycol (40-75% w/w), copolymer of ethylene oxide and propylene oxide (5-15% w/w), stannous fluoride (0.01-3% w/w), abrasive (10-30% w/w) and whitening agent (i.e., hydrogen peroxide source; 1-7% w/w and 4-6% w/w; claims 1 and 18, respectively) overlap with the amounts disclosed in the prior art of propylene glycol (5-60% w/w), copolymer of ethylene oxide and propylene oxide (5-60% w/w), stannous fluoride (0-0.8% w/w), abrasive (15% w/w) and whitening agent (crosslinked PVP hydrogen peroxide; 1-17% w/w), and so a prima facie case of obviousness exists for each claimed range.
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, copolymer of ethylene oxide and propylene oxide, stannous fluoride, abrasive (sodium metaphosphate) and whitening agent (crosslinked PVP hydrogen peroxide; hydrogen peroxide source) within the instantly claimed amounts, in addition to zinc stearate in the instantly claimed amounts and wherein the composition does not comprise water (instant claims 1, 14, 16, 18, 21, and 27). Wherein the copolymer of ethylene oxide and propylene oxide has a molecular weight as instantly claimed (instant claim 11).
Regarding instant claim 38, "even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985) (See MPEP 2113.). In the present case, the prior art product appears to be the same or obvious as claim, despite not teaching the claimed steps of forming zinc stearate, insofar as the prior art composition comprises zinc stearate, as taught above.
Regarding instant claim 25, the formulations are “substantially free of fatty alcohols” (p. 1, para. [0012]), as per claim 25.
In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05(I). In the present case, the instantly claimed range fatty alcohol overlaps with the range of the prior art and so a prima facie case of obviousness exists.
Regarding instant claim 29, Pan discloses antioxidants, such as, “butylated hydroxyanisole (BHA)”, 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, 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, 11, 14, 16, 18, 21, 25, 27, 29, 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) in view of Pan et al. (US 2019/0159981).
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 lubricants including, for example, zinc stearate in amounts from 1% to 15% by weight (i.e., instant claims 1 and 38) [0025]. Potnis also discloses a method comprising applying to composition to the teeth (i.e., instant claim 37) [p. 8, claim 15]. Potnis 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 desires an anti-cavity agent such as sodium fluoride (i.e., instant claim 1 and 21) [0043]. 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. 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] and Potnis welcomes propylene glycol as a humectant [0043].
Potnis does not disclose the instantly claimed amounts of propylene glycol and copolymer of ethylene oxide and propylene oxide.
Pan discloses an oral care composition comprising an orally acceptable vehicle, a peroxide whitening agent and a fatty acid gelling agent, wherein the composition is a toothpaste [p. 6, claim 1]. Pan discloses suitable orally acceptable vehicles include propylene glycol and “block copolymers of ethylene oxide (EO) and propylene oxide (PO)”, e.g. “PLURONIC® P105”, as humectants which may be present “from 5 weight % to about 60 weight %” (p. 2, para. [0031-32]). “PLURONIC® P105” has a molecular weight more than 5000 Da, i.e. about 6500 Da (see USBiological Live Sciences cited by Examiner), as per instant claim 11. Pan desires a composition comprising an abrasive, such as calcium pyrophosphate [0038], in amounts “greater than 0 weight % to about 40 weight %”[0040]. Furthermore, according to Pan a suitable amount of hydrogen peroxide whitening agent for these compositions is “from about 1 weight % […] to about 17 weight %” (i.e., instant claim 18) [0034] and a suitable amount of a fluoride ion source, such as sodium fluoride, is “greater than 0 weight % and less than 0.8 wt %” [0042]. Finally, Pan discloses the composition is anhydrous [0015].
It would have been obvious to one of ordinary skill in the art, at the time of filling, to have combined the toothpaste composition 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 a toothpaste suitable for whitening agents. One would have had an expectation of success because according to Pan the composition disclosed therein are suitable for oral care compositions comprising a peroxide whitening agent. Additionally, Potnis welcomes many of the toothpaste components disclosed by Pan, such as propylene glycol, sodium fluoride, calcium pyrophosphate and whitening agents. Finally, 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.
Additionally, "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 IIA quoting In re Aller, 220 F.2d 454, 456 (105 USPQ 233)). In the present case, it would have been obvious to one of ordinary skill in the art, before the effective filling date of the claimed invention, to have optimized that amount of peroxide whitening agent to provide a suitable amount of hydrogen peroxide in the final toothpaste compositions, as disclosed by Pan (e.g., 1-17% w/w). One would have had an expectation of success because Pan discloses a suitable range for peroxide whitening agents.
Similarly, it would have been obvious to one of ordinary skill in the art, before the effective filling date of the claimed invention, to have optimized the mixing ratio of the solid composition disclosed by Potnis to the toothpaste base disclosed by Pan to ensure optimal workable ranges of each component in the final composition, e.g., zinc stearate. One would have had an expectation of success because Potnis discloses ranges of each component and desires mixing the solid composition with a toothpaste base.
Finally, 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 amounts of propylene glycol (40-75% w/w), copolymer of ethylene oxide and propylene oxide (5-15% w/w), fluoride ion source (sodium fluoride) (0.01-3% w/w), and abrasive (10-30% w/w) overlap with the amounts disclosed in the prior art of propylene glycol (5-60% w/w), copolymer of ethylene oxide and propylene oxide (5-60% w/w), sodium fluoride (0-0.8% w/w), and abrasive (0-40% w/w), and so a prima facie case of obviousness exists for each claimed range.
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, copolymer of ethylene oxide and propylene oxide, sodium fluoride, abrasive (calcium pyrophosphate) and whitening agent (hydrogen peroxide) within the instantly claimed amounts, in addition to zinc stearate in the instantly claimed amounts and wherein the composition does not comprise water (instant claims 1, 14, 16, 18, 21, and 27). Wherein the copolymer of ethylene oxide and propylene oxide has a molecular weight as instantly claimed (instant claim 11).
Regarding instant claim 38, "even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985) (See MPEP 2113.). In the present case, the prior art product appears to be the same or obvious as claim, despite not teaching the claimed steps of forming zinc stearate, insofar as the prior art composition comprises zinc stearate, as taught above.
Regarding instant claim 25, Potnis does not disclose fatty alcohols.
Pan discloses the formulations are “substantially free of fatty alcohols” (p. 1, para. [0012]), as per claim 25.
In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05(I). In the present case, the instantly claimed range of fatty alcohols (less than 5 wt.%) overlaps with the range of the prior art (substantially free of fatty alcohols) and so a prima facie case of obviousness exists.
Regarding instant claim 29, Pan also discloses antioxidants, such as, “butylated hydroxyanisole (BHA)”, 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 and Pan 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 and Pan, as discussed above, to further comprise butylated hydroxyanisole (BHA).
Regarding instant claims 32, 34 and 35, Potnis discloses 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 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 the intended use of Potnis and Pan, as oral care composition.
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, 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, 5, 13, 14, 18, 23, 24, 28, 32, 34, 36, 39, 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 oral care composition comprising an 50-70% w/w propylene glycol and copolymer of ethylene oxide and propylene oxide, 0.01-3% w/w fluoride ion source (e.g., sodium fluoride) an abrasive (e.g., calcium pyrophosphate), anionic surfactants, whitening agent, and 3-10% w/w of one or more gelling agents comprising zinc stearate [claim 1; instant claim 1]. They both claim the whitening agent may be hydrogen peroxide [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; instant claim 25 and 26]. They claim the same abrasives [claim 34; instant claim 27], antioxidants [claim 36; instant claim 29], and pH [claim 1; 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, 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, 12-13, 15, 17, 19, 24, 28, 30, 32, 35, 37, 38 and 39-40 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]. The compositions of the ‘679 claims my comprise 5-15% w/w copolymer of ethylene oxide and propylene oxide and 55-70% w/w propylene glycol [claim 39] which overlaps with the instantly claimed amounts. See MPEP 2144.05(I). Wherein the compositions may comprise 0.01-5% w/w fluoride ion source, such as sodium fluoride [claim 24] and 10-20% w/w abrasives [claim 30], both of which overlap with the instantly claimed ranges. See MPEP 2144.05(I).
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], 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, 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. Additionally, the formulations comprise propylene glycol and “block copolymers of ethylene oxide (EO) and propylene oxide (PO)”, e.g. “PLURONIC® P105” which as a molecular weight more than 5000 Da, i.e. about 6500 Da (see USBiological Live Sciences cited by Examiner; instant claim 11), as humectants which may be present “from 5 weight % to about 60 weight %” (p. 2, para. [0031]). 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. 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 claims 1 and 27. According to Pan the source of hydrogen peroxide “may be present in an amount of from about 1 weight % […] to about 17 weight %” (i.e., instant claim 18) [0034]. Contacting a tooth surface with the formulations, as per claim 37, are anticipated by the intended use of the reference, as oral care composition.
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 pages 8-9 of their Remarks, Applicant asserts that zinc stearate would not inherently form as discussed above, arguing that factors such as other excipients, e.g., sodium metaphosphate, carrier balance, insufficient mixing and insufficient heating might prevent the formation of zinc stearate.
This argument is not persuasive.
“Arguments presented by the applicant cannot take the place of evidence in the record. In re Schulze, 346 F.2d 600, 602, 145 USPQ 716, 718 (CCPA 1965) and In re De Blauwe, 736 F.2d 699, 705, 222 USPQ 191, 196 (Fed. Cir. 1984). Examples of statements which are not evidence and which must be supported by an appropriate affidavit or declaration include statements regarding unexpected results, commercial success, solution of a long-felt need, inoperability of the prior art, invention before the date of the reference, and allegations that the author(s) of the prior art derived the disclosed subject matter from the inventor or at least one joint inventor.” See MPEP 716.01(C)II. In the present case, applicant has not provided evidence to support the assertion that zinc stearate would not form upon combining the components as discussed above, i.e., inoperability of the prior art.
Furthermore, even though the composition comprises other cations in solution a skilled artisans would have nevertheless expected favorable formation of zinc stearate because zinc stearate would have precipitated (zinc stearate is insoluble in water; Potnis at paragraph [0025]) out of the ion dissociations/associations equilibrium. That is to say, once associated, zinc stearate would have remained as an insoluble precipitate, thereby pushing the equilibrium to favor the formation of zinc stearate. One would have expected the carriers to be effective because Pan discloses they are suitable carriers for the disclosed components. While Pan does not disclose a specific mixing protocol, the compositions is nevertheless combined into a single solution and so the ions would have interacted. Finally, even though Pan does not disclose a heating step, such a step does not appear to be necessary for the formation of zinc stearate. For example, see Makowski et al. (US4153588A, publication date 05/08/1979). Makowski discloses “[i]n the 70/45 gums the plasticizer is a mixture of stearic acid and zinc stearate which is formed during neutralization” [col. 20, lines 47-49] wherein the referenced neutralization comprises the mixing of stearic acid into a solution of zinc acetate dihydrate (i.e., zinc ions) [col. 19, lines 50-57]. This is important because the neutralization step if Makowski does not comprise heating.
2) On page 9 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 and Delfanti to cobble together its obviousness allegation with no motivation or reasonable expectation of success.”
This argument is not persuasive. 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, each component, e.g., zinc stearate and zinc citrate trihydrate, was known and disclosed for use in the oral care compositions discussed above.
3) On pages 9 and 11-12 of their Remarks, Applicant argues that the prior art is silent with respect to how the zinc stearate is formed.
This argument is not persuasive. As discussed above, "even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985) (See MPEP 2113.). In the present case, the prior art product appears to be the same or obvious as claim, despite not teaching the claimed steps of forming zinc stearate, insofar as the prior art composition comprises zinc stearate, as taught above.
4) On page 9 of their Remarks, Applicant argues Examples 2-4 of the present invention demonstrate unexpected stability. Additionally, on page 11-12 of their Remarks, Applicant argues: “[l]acking any Examples of or motivation to use gelling agents containing divalent salts of fatty acids [of Potnis], one of skill in the art could not have predicted the unexpected results demonstrated in the present application.”
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 points (i) and (ii).
(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.
5) On page 11 of their Remarks, “Applicant respectfully asserts that this rejection 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. “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.” MPEP2112.01 (II). In the present case, the zinc stearate of Potnis reads on the zinc stearate of the instant claims, regardless of its intended use.
6) On page 12 of their remarks, Applicant asserts Potnis discloses zin stearate as a lubricant, not gelling agent, that Potnis is a solid composition (e.g., tablets powders granules) and that Potnis provides not examples comprising zinc stearate, arguing that “[f]or at least these reasons, one skilled in the art would not have been motivated to combine the cited references or make the modifications necessary to arrive at the claimed invention.”
This argument is not persuasive. In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, a skilled artisan would have been motivated to combined Potnis and Pan because, as discussed above, Potnis desires a toothpaste base and Pan discloses a toothpaste composition suitable for whitening agents.
7) On pages 13-14 of their Remarks, Applicant respectfully requests the rejection be reconsidered and withdrawn in view of the above remarks discussed above.
The conflicting claims continue to read on the instant claims and the double patenting rejections stand for the reasons above and of record.
Conclusion
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.
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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/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.
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