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, 10, 12, 13, 15, 17, 19, 24, 28, 30, 32, 35, and 37-39.
Applicants' arguments, filed 03/04/2026, 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 Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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
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, 10, 12, 13, 15, 17, 19, 24, 28, 30, 38 and 39 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) in view of Johannpeter et al. (US 2009/0005463, Jan. 1, 2009) (hereinafter Johannpeter), as evidenced by US Biological Life Sciences (Pluronic P-105 Technical Data, 2025).
Pan discloses an oral care composition comprising an orally acceptable vehicle, a peroxide whitening agent, and one or more gelling agents. The gelling agents mat 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 water in an amount of less than 5.0 weight % (¶ [0015]). 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). A method of whitening teeth comprises contacting a tooth surface of a subject in need thereof with the oral care composition (claim 16).
Pan differs from the instant claims insofar as not disclosing wherein the composition comprises a sodium 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 and sodium palmitate into the composition of Pan since are known and effective C12-22 fatty acid gelling agents for oral and dental care compositions as taught by Johannpeter.
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) in view of Johannpeter et al. (US 2009/0005463, Jan. 1, 2009) (hereinafter Johannpeter), and further in view of Elejalde et al. (US 2011/0189376, Aug. 4, 2011) (hereinafter Elejalde).
The teachings of Pan and Johannpeter are discussed above. Pan and Johannpeter 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 discloses whereon 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. Claims 32, 35 and 37 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), and further in view of Pan et al. (US 2016/0302011, Oct. 20, 2016) (hereinafter Pan II).
The teachings of Pan I and Johannpeter are discussed above. Pan I and Johannpeter do not teach the amount of antioxidant and wherein the composition comprises about 0.03% to about 5% sodium lauryl sulfate.
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 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.
Response to Arguments
Applicant argues that the high water content formulations of Johannpeter are fundamentally incompatible with the claimed nonaqueous oral care compositions. Accordingly, one of skill in the art would not look to the teachings of Johannpeter to modify the compositions of Pan to arrive at the claimed invention.
The Examiner does not find Applicant’s argument to be persuasive. The rejection does not state to incorporate the entire formulation of Johannpeter into the composition of Pan. The rejection states to incorporate only sodium stearate and sodium palmitate into the composition of Pan. Incorporating only sodium stearate and sodium palmitate would not be incompatible with the claimed nonaqueous oral care composition. Pan discloses wherein the composition comprises C12-28 fatty acid gelling agents. Sodium stearate and sodium palmitate are C12-22 fatty acid gelling agents. Therefore, one of ordinary skill in the art would have had a reasonable expectation of success of incorporating sodium stearate and sodium palmitate into the composition of Pan. As such, Applicant’s argument is unpersuasive.
Applicant argues that Johannpeter explicitly teaches against using propylene oxide-containing substances. Therefore, one of skill in the art would not include substances containing propylene oxide, such as a copolymer of ethylene oxide and propylene oxide, in any formulation.
The Examiner does not find Applicant’s argument to be persuasive. Johannpeter discloses wherein a solubilizer is free from components containing propylene oxide (see abstract and claims 1 and 8 of Johannpeter). Thus, components containing propylene oxide are undesirable for forming a solubilizer. Johannpeter does not disclose wherein components containing propylene oxide are undesirable for forming an oral care composition. As such, Applicant’s argument is unpersuasive.
Applicant argues that Example 2 of the specification shows that the viscosity of the inventive composition remains stable over time, even under elevated temperature storage conditions.
The Examiner does not find Applicant’s argument to be persuasive. Without comparing the claimed composition with another composition, unexpected results with regards to viscosity stability cannot be determined. The claimed subject matter must be compared with the closest prior art to be effective to rebut a prima facie case of obviousness. See MPEP 716.02(e). As such, Applicant’s argument is unpersuasive.
Applicant argues that Example 3 demonstrates that a control formulation lacking the fatty acid salt experiences immediate bloating due to peroxide decomposition, whereas the claimed formulation was stable.
The Examiner does not find Applicant’s argument to be persuasive. The control formulation comprises H2O2 and fatty alcohol, instead of fatty acid salt. This is not the closest prior art. As discussed above, the claimed subject matter must be compared with the closest prior art to be effective to rebut a prima facie case of obviousness. See MPEP 716.02(e). The composition of Pan is the closest prior art because it comprises hydrogen peroxide and fatty acid, which is more closely related to fatty acid salt than fatty alcohol. As such, Applicant’s argument is unpersuasive.
Applicant argues that Elejalde and Pan II do not cure the deficiencies of Pan and Johannpeter.
The Examiner submits that arguments regarding Pan and Johannpeter are addressed above and are unpersuasive. Therefore, the rejections with Elejalde and Pan II are maintained.
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, 10, 12, 13, 15, 17, 19, 24, 28, 30, 32, 35, and 37-39 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3-5, 7, 13, 14, 16-18, 23, 24, 28, 32-34, 36, 39, 42 and 44 of copending Application No. 18/043,703 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the conflicting claims recite a more specific version of the instant claims (i.e., the conflicting claims recite additional gelling agent) and thus read on the instant claims.
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, 10, 12, 13, 15, 17, 19, 24, 28, 30, 32, 35, and 37-39 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 sodium 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]). Therefore, it would have been obvious to have used sodium salt of a fatty acid since it is a suitable gelling agent as taught by Johannpeter.
This is a provisional nonstatutory double patenting rejection.
3. Claims 1, 3-5, 7, 10, 12, 13, 15, 17, 19, 24, 28, 30, 32, 35, and 37-39 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 Pan et al. (US 2019/0159981, May 30, 2019)
The pending claims differ from the copending claims insofar as disclosing a sodium salt of fatty acid and a copolymer of ethylene oxide and propylene oxide. 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]). Therefore, it would have been obvious to have used sodium salt of a fatty acid since it is a suitable gelling agent as taught by Johannpeter. Pan discloses wherein an 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]). Therefore, it would have been obvious to have incorporated a copolymer of ethylene oxide and propylene oxide since it is a known and effective orally acceptable vehicle as taught by Pan.
This is a provisional nonstatutory double patenting rejection.
4. Claims 1, 3-5, 7, 10, 12, 13, 15, 17, 19, 24, 28, 30, 32, 35, and 37-39 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 Pan et al. (US 2019/0159981, May 30, 2019).
The pending claims differ from the copending claims insofar as disclosing a sodium salt of fatty acid and a copolymer of ethylene oxide and propylene oxide. 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]). Therefore, it would have been obvious to have used sodium salt of a fatty acid since it is a suitable gelling agent as taught by Johannpeter. Therefore, it would have been obvious to have used sodium salt of a fatty acid since it is a suitable gelling agent as taught by Joerger. Pan discloses wherein an 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]). Therefore, it would have been obvious to have incorporated a copolymer of ethylene oxide and propylene oxide since it is a known and effective orally acceptable vehicle as taught by Pan.
Response to Arguments
Applicants respectfully defer these issues until the application is otherwise in condition for allowance. Since this has not occurred, the rejection is maintained.
Conclusion
Claims 1, 3-5, 7, 10, 12, 13, 15, 17, 19, 24, 28, 30, 32, 35, and 37-39 are rejected.
No claims are allowed.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/TRACY LIU/Primary Examiner, Art Unit 1614