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, 5, 13, 14, 18, 23, 24, 28, 32, 34, 36, 39 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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 08/21/2026 has been entered.
Applicants' arguments, filed 08/21/2026, 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 Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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, 5, 13, 14, 18, 23, 24, 28, 32, 34, 36 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 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), Acme-Hardesty (Sodium Stearate, Mar. 12, 2014), and Elina Kimya (Calcium Stearate, 2026).
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 sodium monofluorophosphate. 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 7 to about 9.
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.
In regards to instant claim 5 reciting wherein the fatty acids of the monovalent salt and divalent salt have an iodine value of less than 5 or less than 1, as evidenced by Acme-Hardesty, sodium stearate has an iodine value of 4 max and as evidenced by Elina Kimya, calcium stearate has an iodine value of 0.5 max.
2. 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 the skilled artisan would have to make dozens of choices from many disparate lists across at least four different references.
The Examiner does not find Applicant’s argument to be persuasive. Reliance on a large number of references in a rejection does not, without more, weigh against the obviousness of the claimed invention. See In re Gorman, 933 F.2d 982, 18 USPQ2d 1885 (Fed. Cir. 1991). Thus, Applicant’s argument regarding the number of references is unpersuasive. Additionally, 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. Therefore, it would have been obvious to have selected ingredients from other references to incorporate into the primary reference composition based on suitability. As such, Applicant’s argument is unpersuasive.
Applicant argues that the number of selections required makes it almost impossible for the skilled artisan to arrive at the claimed invention.
The Examiner does not find Applicant’s argument to be persuasive. Choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success supports a conclusion of obvious. See MPEP 2143(I). Additionally, a reference that “discloses a multitude of effective combinations does not render any particular formulation less obvious.” Merck & Co., Inc. v. Biocraft Labs., Inc., 874 F.2d 804, 807 (Fed. Cir. 1989). Thus, multiple effective combinations do not make any one combination less obvious. As such, Applicant’s argument is unpersuasive.
Applicant argues that without any indication of the stability of peroxides in the presence of salts of fatty acids or in compositions with the recited pH range, one of skill in the art would have no expectation of success in forming a stable composition as demonstrated by the present application.
The Examiner does not find Applicant’s argument to be persuasive. Pan I teaches a stable composition that exhibits no phase separation. The composition of Pan I does not comprise the claimed fatty acid salts or have the recited pH. Thus, Applicant has not shown wherein the claimed salts of fatty acids and the claimed pH range are critical. As such, Applicant’s argument is unpersuasive.
Applicant argues that Nesta would not cure the deficiencies of Pan I, Johannpeter, Moaseri, and Pan II.
The Examiner submits that Applicant’s arguments regarding Pan I, Johannpeter, Moaseri, and Pan II are unpersuasive. As such, the rejection 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, 5, 13, 14, 18, 23, 24, 28, 32, 34, 36, 39 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, 5, 13, 14, 18, 23, 24, 28, 32, 34, 36, 39 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, 5, 13, 14, 18, 23, 24, 28, 32, 34, 36, 39 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, 5, 13, 14, 18, 23, 24, 28, 32, 34, 36, 39 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, 5, 13, 14, 18, 23, 24, 28, 32, 34, 36, 39 and 44 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