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 37-40.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 06/19/2026 has been entered.
Applicants' arguments, filed 06/19/2026, 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 Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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, 3-5, 7, 10, 12, 13, 15, 17, 19, 24, 28, 30 and 38-40 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) and Elejalde et al. (US 2011/0189376, Aug. 4, 2011) (hereinafter Elejalde), 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 fatty acid gelling agent. Accordingly, it would have been obvious to one of ordinary skill in the art to have incorporated a sodium salt of the fatty acid gelling agent (e.g., sodium stearate and sodium palmitate) into the composition of Pan since they are known and effective fatty acid gelling agents for oral and dental care compositions as taught by Johannpeter.
The combined teachings of Pan and Johannpeter do not teach 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 can contain non-trans fatty acids (¶ [0221]).
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 wherein the composition comprises fatty acids. Accordingly, it would have been obvious to one of ordinary skill in the art to have incorporated a fatty acid with an iodine value of 10 or less into the composition since this is a known and effective fatty acid for oral compositions as taught by Elejalde.
2. 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), Elejalde et al. (US 2011/0189376, Aug. 4, 2011) (hereinafter Elejalde), and further in view of Pan et al. (US 2016/0302011, Oct. 20, 2016) (hereinafter Pan II).
The teachings of Pan I, Johannpeter and Elejalde are discussed above. Pan I Johannpeter, and Elejalde 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 Elejalde is directed towards sugar free confectionary products. The present application is directed towards the stability of peroxide in high pH oral care compositions. Elejalde is silent on peroxides and their stability. Accordingly, one of skill in the art would not look to the disclosure of Elejalde when working to formulate an oral care composition containing peroxides.
The Examiner does not find Applicant’s argument to be persuasive. In order for a reference to be proper for use in an obviousness rejection under 35 U.S.C. 103, the reference must be analogous art to the claimed invention. A reference is analogous art to the claimed invention if: (1) the reference is from the same field of endeavor as the claimed invention (even if it addresses a different problem); or (2) the reference is reasonably pertinent to the problem faced by the inventor (even if it is not in the same field of endeavor as the claimed invention). See MPEP 2141.01(a). Thus, since it is not necessary for a reference to be reasonably pertinent to the problem faced by the inventor, Elejalde does not need to address Applicant’s problem of peroxides and its stability. Elejalde is in the same field of endeavor as the claimed invention by disclosing an oral composition. As such, it is proper to use the teachings of Elejalde in the rejection and Applicant’s argument is unpersuasive.
Applicant argues that Elejalde discloses iodine values for fat/oil, not for a fatty acid.
The Examiner does not find Applicant’s argument to be persuasive. Elejalde discloses in paragraph [0221] wherein the fat/oil can contain non-trans fatty acids. As such, Elejadle does disclose iodine values for a fatty acid and 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 Pan II does not cure the deficiencies of Pan, Johannpeter, and Elejalde.
The Examiner submits that arguments regarding Pan, Johannpeter, and Elejalde are addressed above and are unpersuasive. Therefore, the rejection with Pan II is 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 37-40 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 37-40 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) and Elejalde et al. (US 2011/0189376, Aug. 4, 2011) (hereinafter Elejalde).
The pending claims differ from the copending claims insofar as disclosing a sodium salt of fatty acid and an iodine value of less than 5. 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. 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 can contain non-trans fatty acids (¶ [0221]). Accordingly, it would have been obvious to one of ordinary skill in the art to have incorporated a fatty acid with an iodine value of 10 or less into the composition since this is a known and effective fatty acid for oral compositions as taught by Elejalde.
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 37-40 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), Pan et al. (US 2019/0159981, May 30, 2019), and Elejalde et al. (US 2011/0189376, Aug. 4, 2011) (hereinafter Elejalde).
The pending claims differ from the copending claims insofar as disclosing a sodium salt of fatty acid, a copolymer of ethylene oxide and propylene oxide, and an iodine value of less than 5. 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. 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 can contain non-trans fatty acids (¶ [0221]). Accordingly, it would have been obvious to one of ordinary skill in the art to have incorporated a fatty acid with an iodine value of 10 or less into the composition since this is a known and effective fatty acid for oral compositions as taught by Elejalde.
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 37-40 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), Pan et al. (US 2019/0159981, May 30, 2019), and Elejalde et al. (US 2011/0189376, Aug. 4, 2011) (hereinafter Elejalde).
The pending claims differ from the copending claims insofar as disclosing a sodium salt of fatty acid, a copolymer of ethylene oxide and propylene oxide, and a iodine value of less than 5. 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. 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 can contain non-trans fatty acids (¶ [0221]). Accordingly, it would have been obvious to one of ordinary skill in the art to have incorporated a fatty acid with an iodine value of 10 or less into the composition since this is a known and effective fatty acid for oral compositions as taught by Elejalde.
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 37-40 are rejected.
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TRACY LIU whose telephone number is (571)270-5115. The examiner can normally be reached Mon-Fri 9 am - 5 pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Ali Soroush can be reached at 571-272-9925. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/TRACY LIU/Primary Examiner, Art Unit 1614
Prosecution Insights