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 . Claims included in the prosecution are claims 1, 3-5, 7, 13, 14, 16-18, 23, 24, 28, 32, 34, 36, 39, 42 and 44.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 12/05/2025 has been entered.
Applicants' arguments, filed 11/05/2025, 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 Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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
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.
1. Claims 1, 3, 4, 7, 13, 14, 16-18, 23, 24, 28, 32, 34, 36, 39 and 42 are rejected under 35 U.S.C. 103 as being unpatentable over Pan et al. (US 2019/0159981, May 30, 2019) (IDS reference) (hereinafter Pan I) in view of Johannpeter et al. (US 2009/0005463, Jan. 1, 2009) (hereinafter Johannpeter), Moaseri (US 2021/0077411, Priority Date Sep. 12, 2019), and Pan et al. (US 2016/0303011, Oct. 20, 2016) (hereinafter Pan II), as evidenced by US Biological Life Sciences (Pluronic P-105 Technical Data, 2025).
Pan I discloses an oral care composition comprising an orally acceptable vehicle, a peroxide whitening agent, and one or more gelling agents. The gelling agents may include a fatty acid (abstract). The oral care composition prior to use may be anhydrous (¶ [0028]). The fatty acid includes a C12-C28 fatty acid (¶ [0006]). The fatty acid includes a saturated fatty acid (¶ [0008]) or an unsaturated fatty acid (¶ [0009]). Examples of fatty acids include stearic acid and palmitic acid (¶ [0007]). The gelling agents are present in an amount of from about 1 weight % to about 50 weight % (¶ [0011]). The orally acceptable vehicle may include one or more humectants such as glycerin, propylene glycol, polyethylene glycol, and block copolymers of ethylene oxide and propylene oxide. Illustrative block copolymers of ethylene oxide and propylene oxide include PLURONIC® P105 (¶ [0031]). As evidenced by US Biological Life Sciences, Pluronic P-105 has a molecular weight of 6500. The orally acceptable vehicle may be present in an amount of from 5 weight % to about 60 weight % (¶ [0032]). The peroxide whitening agent includes hydrogen peroxide or one or more sources of hydrogen peroxide. Exemplary peroxide whitening agents include hydrogen peroxide, peroxides of alkali and alkaline earth metals, organic peroxy compounds, and peroxy acids (¶ [0034]). The source of hydrogen peroxide may be present in an amount of from about 1 weight % to about 30 weight % (¶ [0034]). The oral care composition may further include fluoride (¶ [0041]). Illustrative fluoride ion sources include stannous fluoride. The amount of the fluoride ion source may be greater than 0 weight % and less than 0.8 weight % (¶ [0042]). The oral care composition may include fatty alcohols in an amount of less than 5.0 weight % (¶ [0013]). The oral care composition may include an abrasive, such as sodium metaphosphate (¶ [0038]). The amount of abrasives may be from greater than 0 weight % to about 40 weight % (¶ [0040]). The oral care composition may include an antioxidant such as butylated hydroxytoluene (BHT) (¶ [0046]). Surfactants may also be included in the composition (Table 1).
Pan I differs from the instant claims insofar as not disclosing wherein the composition comprises a monovalent salt of a fatty acid as the gelling agent.
However, Johannpeter discloses a cosmetic, dermatological, or pharmaceutical formulation comprising gelling agents (¶ [0052]). Cosmetic, dermatological or pharmaceutical formulations include oral and dental care compositions (¶ [0026]). Suitable gelling agents include metal salts of fatty acids, preferably having 12 to 22 carbon atoms, for example sodium stearate, sodium palmitate, and mixtures thereof (¶ [0099]).
Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use. See MPEP 2144.07. The oral care composition comprises a C12-C28 fatty acid gelling agent. Accordingly, it would have been obvious to one of ordinary skill in the art to have incorporated sodium stearate or sodium palmitate into the composition of Pan I since they are known and effective C12-22 fatty acid gelling agents for oral and dental care compositions as taught by Johannpeter.
The combined teachings of Pan I and Johannpeter do not teach wherein the composition comprises a divalent salt of a fatty acid.
However, Moaseri discloses products encapsulating nutrients or other payloads (¶ [0002]). The product may be an oral care product (¶ [0339]). The product may include a lipophilic surface active agent, which may include a metal cation, to cause gelation of an aqueous soluble/gellable polysaccharide. Lipophilic surface active agents may include C6-C20 fatty acids including an appropriate metal cation, for example, calcium stearate, calcium palmitate or other calcium, copper, zinc, potassium or other metal cation salt of a C6-C20 fatty acid (¶ [0162]).
Pan I discloses wherein the composition may comprise one or more C12-C28 fatty acid gelling agent, wherein examples of fatty acids include stearic acid and palmitic acid. Accordingly, it would have been obvious to one of ordinary skill in the art to have incorporated calcium palmitate, calcium stearate, or a zinc salt of stearic acid and palmitic acid into the composition of Pan I since they are known and effective C6-20 fatty acid gelling agents for oral care compositions as taught by Moaseri.
The combined teachings of Pan I, Johannpeter, and Moaseri do not teach the amount of antioxidant, wherein the composition comprises about 0.03% to about 5% sodium lauryl sulfate, and wherein the pH of the composition is from about 6 to about 10.
However, Pan II discloses an oral care composition (abstract). The composition may comprise 0.01-5% antioxidant e.g., BHT and 0-5% surfactant, e.g., SLS (¶ [0033]). The composition has a pH of about 5 to about 9 (¶ [0047]).
The composition of Pan I comprises antioxidants. Accordingly, it would have been obvious to have incorporated 0.01-5% antioxidant into the composition of Pan I since this is a known and effective amount of antioxidants for oral care compositions as taught by Pan II.
The composition of Pan I comprises surfactants. Accordingly, it would have been obvious to have incorporated 0-5% SLS into the composition of Pan I since this is a known and effective surfactant and amount thereof for oral care compositions as taught by Pan II.
Pan I does not disclose the pH of the composition. Accordingly, it would have been obvious to one of ordinary skill in the art to have formulated the composition of Pan I to have a pH of about 5 to about 9 since this is a known and effective pH for oral care compositions as taught by Pan II.
In regards to instant claim 1 reciting wherein the composition is physically stable by exhibiting no phase separation over at least one week at a temperature of 60°C, Pan I discloses in paragraph [0054] and in Table 4 wherein the composition exhibited no phase separation for 13 weeks at 40°C. Accordingly, since the composition of Pan is phase stable at high temperatures for 13 weeks, one of ordinary skill in the art would reasonably expect the composition of Pan I to also exhibit no phase separation over at least one week at a high temperature such as 60°C.
2. Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Pan et al. (US 2019/0159981, May 30, 2019) (IDS reference) (hereinafter Pan I) in view of Johannpeter et al. (US 2009/0005463, Jan. 1, 2009) (hereinafter Johannpeter), Moaseri (US 2021/0077411, Priority Date Sep. 12, 2019), Pan et al. (US 2016/0303011, Oct. 20, 2016) (hereinafter Pan II), and further in view of Elejalde et al. (US 2011/0189376, Aug. 4, 2011) (hereinafter Elejalde).
The teachings of Pan I, Johannpeter, Moaseri, and Pan II are discussed above. Pan I, Johannpeter, Moaseri, and Pan II do not teach wherein the unsaturated fatty acid has an iodine value of less than 5.
However, Elejalde discloses a sugar free confectionery product (abstract). The confectionery composition comprises an oil or fat. The oil or fat has an iodine value of 10 or less (¶ [0055]). The fat/oil may contain monounsaturated fatty acids (¶ [0222]).
Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use. See MPEP 2144.07. Pan I discloses wherein the composition comprises unsaturated fatty acids. Accordingly, it would have been obvious to one of ordinary skill in the art to have incorporated an unsaturated fatty acid with an iodine value of 10 or less into the composition since this is a known and effective unsaturated fatty acid for oral compositions as taught by Elejalde.
3. Claim 44 is rejected under 35 U.S.C. 103 as being unpatentable over Pan et al. (US 2019/0159981, May 30, 2019) (IDS reference) (hereinafter Pan I) in view of Johannpeter et al. (US 2009/0005463, Jan. 1, 2009) (hereinafter Johannpeter), Moaseri (US 2021/0077411, Priority Date Sep. 12, 2019), Pan et al. (US 2016/0303011, Oct. 20, 2016) (hereinafter Pan II), and further in view of Nesta et al. (US 2018/0153781, Jun. 7, 2018) (hereinafter Nesta).
The teachings of Pan I, Johannpeter, Moaseri, and Pan II are discussed above. Pan I, Johannpeter, Moaseri, and Pan II do not teach wherein the composition has a viscosity of from about 500,000 cPs to about 1,750,000 cPs.
However, Nesta discloses a non-aqueous dentifrice composition (abstract). It is preferred that the carriers in the dentifrice provide a dentifrice with a viscosity of about 10,000 cPs to about 700,000 cPs (¶ [0031]).
Pan I does not disclose a viscosity for the oral care composition. Accordingly, it would have been prima facie obvious to one of ordinary skill in the art to have formulated the composition of Pan I to have a viscosity of about 10,000 cPs to about 700,000 cPs since this is a known and effective viscosity for formulating non-aqueous oral care compositions as taught by Nesta.
Response to Arguments
Applicant argues that Pan reports that fatty alcohol containing oral care compositions result in peroxide decomposition and excessive bloating that may cause toothpaste tubes to burst. Accordingly, one skilled in the art armed with Pan would not have been motivated to incorporate the teachings of Pan II in the Pan compositions.
The Examiner does not find Applicant’s argument to be persuasive. Pan recites in claim 9 wherein the oral care composition comprises fatty alcohols in an amount of less than 5.0 wt. %. Pan II recites in claim 4 a dentifrice composition comprising about 0.1 to about 20 wt. % fatty alcohol. Therefore, since Pan discloses wherein the composition may comprise a low amount of fatty alcohols (i.e., less than 5 wt. %) and the composition of Pan II comprises a low amount of fatty alcohols (e.g., 0.1 wt. %), one of ordinary skill in the art would not find Pan II to be teaching away and Applicant’s argument is unpersuasive.
Applicant argues that Pan II does not disclose the pH of any of its exemplary formulations.
The Examiner does not find Applicant’s argument to be persuasive. A prior art reference is evaluated for all that it reasonably suggests and is not limited to working examples. As such, Applicant’s argument is unpersuasive.
Applicant argues that it is known in the art that peroxides decompose under higher pH conditions.
The Examiner does not find Applicant’s argument to be persuasive. Applicant has not provided objective evidence to support their assertion. Therefore, Applicant’s argument is merely speculative and is unpersuasive.
Applicant argues that one of skill in the art could not have predicted that the combination of a peroxide source and salts of a fatty acids would produce a stable composition in the recited pH range.
The Examiner does not find Applicant’s argument to be persuasive. Pan II disclose a dentifrice that is stable (¶ [0005]) and comprising a peroxide source (claim 1) and fatty acids (¶ [0042]), wherein the composition has a pH of about 6 to about 8 (¶ [0047]). Therefore, Applicant argument that one would not expect a composition comprising a peroxide source and salts of a fatty acids and having a pH of from about 6 to about 10 to be stable is not persuasive. Also, as discussed above, Applicant has not provided objective evidence to support their assertion that peroxides decompose under higher pH conditions. Therefore, there is no reason for one of ordinary skill in the art to expect the claimed composition to be unexpected.
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. Claims 1, 3-5, 7, 13, 14, 16-18, 23, 24, 28, 32, 34, 36, 39, 42 and 44 are 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 and 38 of copending Application No. 18/043,679 (reference application) in view of Moaseri (US 2021/0077411, Priority Date Sep. 12, 2019).
The pending claims differ from the conflicting claims insofar as reciting a divalent salt of a fatty acid ester. However, Moaseri discloses products encapsulating nutrients or other payloads (¶ [0002]). The product may be an oral care product (¶ [0339]). The product may include a lipophilic surface active agent, which may include a metal cation, to cause gelation of an aqueous soluble/gellable polysaccharide. Lipophilic surface active agents may include C6-C20 fatty acids including an appropriate metal cation, for example, calcium stearate, calcium palmitate or other calcium, copper, zinc, potassium or other metal cation salt of a C6-C20 fatty acid (¶ [0162]).
Accordingly, it would have been prima facie obvious to one of ordinary skill in the art to have incorporated a divalent salt of a fatty acid into the pending claims since they are known and effective gelling agents for oral care compositions as taught by Moaseri.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
2. Claims 1, 3-5, 7, 13, 14, 16-18, 23, 24, 28, 32, 34, 36, 39, 42 and 44 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3-5, 8-11, 14, 16, 18, 21, 25-27, 29, 32, 34, 35 and 37 of copending Application No. 18/043,695 in view of Johannpeter et al. (US 2009/0005463, Jan. 1, 2009) (hereinafter Johannpeter).
The pending claims differ from the copending claims insofar as disclosing a monovalent salt of fatty acid. However, Johannpeter discloses a cosmetic, dermatological, or pharmaceutical formulation comprising gelling agents (¶ [0052]). Cosmetic, dermatological or pharmaceutical formulations include oral and dental care compositions (¶ [0026]). Suitable gelling agents include metal salts of fatty acids, preferably having 12 to 22 carbon atoms, for example sodium stearate, sodium palmitate, and mixtures thereof (¶ [0099]).
Accordingly, it would have been obvious to one of ordinary skill in the art to have incorporated a monovalent salt of fatty acid into the pending claims since it is a known and effective gelling agent for oral care compositions as taught by Johannpeter.
This is a provisional nonstatutory double patenting rejection.
3. Claims 1, 3-5, 7, 13, 14, 16-18, 23, 24, 28, 32, 34, 36, 39, 42 and 44 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 and 12-17 of copending Application No. 17/472,241 in view of Johannpeter et al. (US 2009/0005463, Jan. 1, 2009) (hereinafter Johannpeter) and Moaseri (US 2021/0077411, Priority Date Sep. 12, 2019).
The pending claims differ from the copending claims insofar as disclosing a monovalent salt of fatty acid and divalent salt of fatty acid. However, Johannpeter discloses a cosmetic, dermatological, or pharmaceutical formulation comprising gelling agents (¶ [0052]). Cosmetic, dermatological or pharmaceutical formulations include oral and dental care compositions (¶ [0026]). Suitable gelling agents include metal salts of fatty acids, preferably having 12 to 22 carbon atoms, for example sodium stearate, sodium palmitate, and mixtures thereof (¶ [0099]). Moaseri discloses products encapsulating nutrients or other payloads (¶ [0002]). The product may be an oral care product (¶ [0339]). The product may include a lipophilic surface active agent, which may include a metal cation, to cause gelation of an aqueous soluble/gellable polysaccharide. Lipophilic surface active agents may include C6-C20 fatty acids including an appropriate metal cation, for example, calcium stearate, calcium palmitate or other calcium, copper, zinc, potassium or other metal cation salt of a C6-C20 fatty acid (¶ [0162]).
Accordingly, it would have been obvious to one of ordinary skill in the art to have incorporated a monovalent salt of fatty acid and divalent salt of fatty acid into the pending claims since they are known and effective gelling agents for oral care compositions as taught by Johannpeter and Moaseri.
This is a provisional nonstatutory double patenting rejection.
4. Claims 1, 3-5, 7, 13, 14, 16-18, 23, 24, 28, 32, 34, 36, 39, 42 and 44 are 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 Johannpeter et al. (US 2009/0005463, Jan. 1, 2009) (hereinafter Johannpeter) and Moaseri (US 2021/0077411, Priority Date Sep. 12, 2019).
The pending claims differ from the copending claims insofar as disclosing a monovalent salt of fatty acid and a divalent salt of fatty acid. However, Johannpeter discloses a cosmetic, dermatological, or pharmaceutical formulation comprising gelling agents (¶ [0052]). Cosmetic, dermatological or pharmaceutical formulations include oral and dental care compositions (¶ [0026]). Suitable gelling agents include metal salts of fatty acids, preferably having 12 to 22 carbon atoms, for example sodium stearate, sodium palmitate, and mixtures thereof (¶ [0099]). Moaseri discloses products encapsulating nutrients or other payloads (¶ [0002]). The product may be an oral care product (¶ [0339]). The product may include a lipophilic surface active agent, which may include a metal cation, to cause gelation of an aqueous soluble/gellable polysaccharide. Lipophilic surface active agents may include C6-C20 fatty acids including an appropriate metal cation, for example, calcium stearate, calcium palmitate or other calcium, copper, zinc, potassium or other metal cation salt of a C6-C20 fatty acid (¶ [0162]).
Accordingly, it would have been obvious to one of ordinary skill in the art to have incorporated a monovalent salt of fatty acid and divalent salt of fatty acid into the pending claims since they are known and effective gelling agents for oral care compositions as taught by Johannpeter and Moaseri.
Response to Arguments
Applicants respectfully defer these issues until the application is otherwise in condition for allowance. Since this has not occurred, the rejections are maintained.
Conclusion
Claims 1, 3-5, 7, 13, 14, 16-18, 23, 24, 28, 32, 34, 36, 39, 42 and 44 are rejected.
No claims are allowed.
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/TRACY LIU/Primary Examiner, Art Unit 1614