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 1-20.
Applicants' arguments, filed 09/22/2025, 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 Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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 § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 7 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 7 recites wherein the composition comprises 2-20% cellulose. The claim is indefinite since it is unclear whether the claim is further limiting the amount of methyl cellulose, which is a cellulose, recited in claim 1 or whether the claim is reciting wherein the composition comprises an additional cellulose.
Response to Arguments
Applicant argues that it is well known in the art that methyl cellulose recited in claim 1 and cellulose recited in claim 7 refer to two different substances.
The Examiner does not find Applicant’s argument to be persuasive. Applicant has not shown wherein it is well known in the art that methyl cellulose and cellulose refer to two different substances. Methyl cellulose is a type of cellulose so it is reasonable for one of ordinary skill in the art to think that they are the same. Furthermore, Applicant can obviate this issue by reciting “further comprising” instead of “comprising” in claim 7.
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 1-6, 8, 9 and 11-18 are rejected under 35 U.S.C. 103 as being unpatentable over Nanda (US 2013/0344009, Dec. 26, 2013) in view of Gaserod et al. (US 2005/0137272, Jun. 23, 2005) (hereinafter Gaserod), as evidenced by PubChem (Methyl Cellulose, 2025).
Nanda discloses an oral care composition comprising a surfactant and/or a foaming agent to cause the composition to foam prior to administration to an oral cavity (abstract). The composition includes an effective amount of one or more active ingredients, such as anticaries, and at least one solvent. The composition optionally includes one or more sweeteners, one or more preservatives, and one or more thickening agents. The composition may also include abrasive material, such as colloidal or hydrated silica (¶ [0008]). In an exemplary embodiment, the composition comprises 5-20 wt.% glycerin (i.e., humectant) as a solvent, 0.01-1 wt. % sucralose as a sweetener (i.e., flavoring agent), and 0.01-0.25 wt. % sodium fluoride as an anti-cavity agent (i.e., functional additive) (¶ [0032]). The composition may comprise 0-10 wt. % of the hydrated silica (i.e., abrasive) (¶ [0035]). The composition may comprise 1.5-10 wt. % surfactant/foaming agent (¶ [0032]).
Nanda differs from the instant claims insofar as not disclosing wherein the composition comprises methyl cellulose.
However, Gaserod discloses gelled biopolymer-based foams comprising a foaming agent and used in oral hygiene (abstract). Suitable foaming agents include methyl cellulose (claim 3).
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. Nanda discloses wherein the oral care composition comprises a foaming agent. Accordingly, it would have been obvious to one of ordinary skill in the art to have incorporated methyl cellulose into the composition of Nanda since it is a known and effective foaming agent for oral use as taught by Gaserod.
In regards to instant claim 1 reciting a surface tension of the methyl cellulose in an aqueous solution at a concentration of 0.1 mass % is less than 60 mN/m, as evidenced by PubChem, methyl cellulose has a surface tension of 47-53 dyn/cm at 0.1% solution. Accordingly, since this is an inherent property of methyl cellulose, the methyl cellulose of the prior art necessarily has the same property.
In regards to instant claim 1 reciting wherein the composition does not comprise surfactants, Nanda discloses wherein the composition comprises surfactants and/or foaming agents. Thus, the composition may comprise foaming agents and not surfactants.
In regards to instant claims 9 and 18 reciting wherein the composition does not comprise preservatives, since Nanda discloses wherein preservatives are optional, it would have been obvious to one of ordinary skill in the art that the composition may be free of preservatives.
Response to Arguments
Applicant argues that it is not true that all types of methyl cellulose have a surface tension of 47-53 dyn/cm at 0.1% solution. For example, as shown in the present specification, some methyl cellulose has a surface tension of 72.79 mN/m, 60 mN/m, and 71.90 mN/m at 0.1% solution. And the methyl cellulose having a surface tension of 72.79 72.79 mN/m, 60 mN/m, or 71.90 mN/m at 0.1% solution actually has foaming incapability.
The Examiner does not find Applicant’s argument to be persuasive. The surface tension of a methyl cellulose solution depends on its concentration. It is not clear how multiple aqueous solutions comprising the same amount of methyl cellulose at 0.1% can each have a different surface tension. Therefore, since Applicant’s showing is unclear, Applicant’s argument is unpersuasive and the rejection is maintained.
Applicant argues that the only and particularly desirable foaming agent taught in Nanda is cocamidopropyl betaine. Cocamidopropyl betaine is also a surfactant.
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 preferred embodiments or working examples. Nanda discloses in the abstract that the composition includes a surfactant and/OR a foaming agent. Thus, the composition of Nanda may comprise a foaming agent and not a surfactant. Foaming agents and surfactants are not synonymous. Gaserod discloses in paragraph [0058] wherein for certain applications, a surfactant may be used as the foaming agent. Gaserod also discloses in paragraph [0053] wherein the foaming agent may be a polymeric foaming agent, a surfactant, or a mixture thereof. As such, a surfactant is not required in Nanda’s composition and Applicant’s argument is unpersuasive.
Applicant argues that it is clear that the compositions taught in Nanda must either contain a primary surfactant alone or a primary surfactant plus a foaming agent. This is supported by claims and actual exemplarily compositions taught in Nanda.
The Examiner does not find Applicant’s argument to be persuasive. As discussed above, a prior art reference is evaluated for all that it reasonably suggests and is not limited to preferred embodiments or working examples. Nanda discloses in the abstract that the composition includes a surfactant and/OR a foaming agent. Nanda discloses in paragraphs [0008] and [0013] wherein the composition comprises at least one surfactant OR foaming agent. As such, a surfactant is not required in Nanda’s composition and Applicant’s argument is unpersuasive.
Applicant argues that there is no evidence to show that the skilled artisan would use methyl cellulose taught in Gaserod as a secondary surfactant.
The Examiner does not find Applicant’s argument to be persuasive. As discussed above, Nanda’s composition requires a surfactant and/OR foaming agent. The term “or” means that the composition may comprise only one of those compounds. Since Gaserod teaches that methyl cellulose is a foaming agent and Nanda’s composition comprises a foaming agent, it would have been obvious to one of ordinary skill in the art to have incorporated methyl cellulose into Nanda’s composition as a suitable and effective foaming agent. As such, Applicant’s argument is unpersuasive.
Applicant argues claim 1 is obvious over the combination of the cited art because, allegedly, methyl cellulose taught in Gaserod could be used in Nanda’s compositions. But this is not the correct inquiry and standard for analyzing the obviousness issue.
The Examiner does not find Applicant’s argument to be persuasive. The rationale used in the rejection is supported in the MPEP. Section 2144.07 of the MPEP states that it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use. Nanda’s composition comprises a foaming agent. Methyl cellulose is suitable for the composition of Nanda since it is a known and effective foaming agent as taught by Gaserod. Applicant has not shown wherein methyl cellulose would not be suitable. Therefore, the rejection is a proper obviousness rejection and Applicant’s argument is unpersuasive.
Applicant argues that combining the cited references to arrive at the method of the present claim 1 would change the principle of operation of using one or two surfactant(s) for foaming to using methyl cellulose for foaming.
The Examiner does not find Applicant’s argument to be persuasive. As discussed above, Nanda teaches wherein the composition may comprising a foaming agent and not a surfactant. As such, Applicant’s argument is unpersuasive.
Applicant argues that the composition encompassed by the present claim 1 possess superior technical properties as compared with oral care compositions containing a surfactant, i.e., almost identical foaming effect as compared to surfactant-containing toothpaste sold in the mark without using any surfactant, achieving a preservative effect by controlling the water activity Aw to be less than 0.7, and avoiding harmful or undesirable effect of chemical components in toothpaste containing a surfactant.
The Examiner does not find Applicant’s argument to be persuasive. The claimed composition comprises methyl cellulose, which is a foaming agent as taught by Gaserod. Therefore, it is not unexpected for the claimed composition to foam like a surfactant-containing toothpaste. Furthermore, Applicant has not made any comparisons with compositions comprising a water activity outside of the claimed range. Therefore, Applicant’s argument that the claimed water activity is unexpected is not persuasive. It should also be noted that the independent claim does not recite water activity. Moreover, Applicant tested safety and toxicity by having mung beans grown in the composition. It is not clear how having mung beans sprout shows that the composition is safe and nontoxic for the human oral cavity. There are no mung beans in the human oral cavity. As such, Applicant’s argument is unpersuasive.
2. Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Nanda (US 2013/0344009, Dec. 26, 2013) in view of Gaserod et al. (US 2005/0137272, Jun. 23, 2005) (hereinafter Gaserod), and further in view of Patel et al. (US 2015/0335548, Nov. 26, 2015) (hereinafter Patel).
The teachings of Nanda and Gaserod are discussed above. Nanda and Gaserod do not disclose wherein the composition comprises 2-20% cellulose, 5-30% lactobacillus fermentation compound, and 1-12% starch.
However, Patel discloses an oral care composition (abstract). The composition may comprise a saliva stimulating agent useful in amelioration of dry mouth. Suitable saliva stimulating agents include lactic acid. The saliva stimulating agent is present in a saliva stimulating effective total amount (¶ [0148]). The composition comprises at least one thickening agent. Suitable thickening agents include cellulosic polymers. One or more thickening agents are present in a total amount of from about 0.01 wt. % to 15 wt. % (¶ [0141]). The composition also comprises at least one sweetener. Suitable sweeteners include partially hydrolyzed starch and hydrogenated starch hydrolysate. One or more sweeteners may be present in a total amount depending strongly on the particular sweetener(s) selected, but typically 0.005 wt. % to 5 wt. % (¶ [0144]).
Accordingly, it would have been prima facie obvious to one of ordinary skill in the art to have incorporated lactic acid (i.e., lactobacillus fermentation compound) into the composition of Nanda motivated by the desire to ameliorate dry mouth as taught by Patel. With regards to the claimed amount, it would have taken no more than the relative skills of one of ordinary skill in the art to have arrived at the claimed amount through routine experimentation since Patel discloses wherein the amount should be in a saliva stimulating effective amount. Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. See MPEP 2144.05(II)(A).
Moreover, 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. Nanda discloses wherein the oral care composition comprises one or more thickening agents and one or more sweeteners. Accordingly, it would have been obvious to one of ordinary skill in the art to have incorporated about 0.01 wt. % to 15 wt. % cellulosic polymers and 0.005 wt. % to 5 wt. % partially hydrolyzed starch or hydrogenated starch hydrolysate into the composition of Nanda since these are known and effective thickening agents and sweeteners and amounts thereof, respectively, for oral care compositions as taught by Patel.
Response to Arguments
Applicant argues that Patel fails to cure the deficiencies of Nanda in view of Gaserod.
The Examiner submits that arguments regarding Nanda and Gaserod have been discussed above and are unpersuasive. Therefore, the rejection is maintained.
3. Claims 10, 19 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Nanda (US 2013/0344009, Dec. 26, 2013) in view of Gaserod et al. (US 2005/0137272, Jun. 23, 2005) (hereinafter Gaserod), and further in view of Burgess et al. (US 2015/0125404, May 7, 2015) (hereinafter Burgess).
The teachings of Nanda and Gaserod are discussed above. Nanda and Gaserod do not disclose wherein the composition has a water activity of less than 0.75, 0.65, or 0.60.
However, Burgess discloses a dentifrice composition, wherein the composition has a water activity from about 0.25 to about 0.46 (abstract). Water activity is an important property of topical compositions such as oral care compositions including dentifrice. Water activity can affect ingredient solubility which in turn can be used to modify product rheology (¶ [0054]).
Accordingly, it would have been prima facie obvious to one of ordinary skill in the art to have formulated the composition of Burgess with a water activity from about 0.25 to about 0.46 motivated by the desire to obtain a composition with desirable rheology as taught by Burgess.
Response to Arguments
Applicant argues that Burgess fails to cure the deficiencies of Nanda in view of Gaserod.
The Examiner submits that arguments regarding Nanda and Gaserod have been discussed above and are unpersuasive. Therefore, 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.
Claims 1-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No. 18/024,838 in view of Gaserod et al. (US 2005/0137272, Jun. 23, 2005) (hereinafter Gaserod).
The pending claims differ from the conflicting claims insofar as reciting methyl cellulose. However, Gaserod discloses a gelled biopolymer-based foam for use in oral hygiene comprising a foaming agent (abstract) such as methyl cellulose (claim 3). Accordingly, it would have been obvious to one of ordinary skill in the art to have substituted hydroxypropyl methyl cellulose for methyl cellulose since it is another known and effective foaming agent as taught by Gaserod.
This is a provisional nonstatutory double patenting rejection.
Response to Arguments
Applicant’s arguments have been addressed above and are unpersuasive. Therefore, the rejection is maintained.
Conclusion
Claims 1-20 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