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.
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 oral care composition comprises 2-20% cellulose. The claim is indefinite since it is not clear if the claim is further limiting the amount of hydroxypropyl methyl cellulose in claim 1 or is reciting wherein the composition further comprises a cellulose compound different from hydroxypropyl methyl cellulose recited in claim 1.
Response to Arguments
Applicant argues that it is well known in the art that hydroxypropyl 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 provided any evidence showing wherein it is well known in the art that hydroxypropyl methyl cellulose recited in claim 1 and cellulose recited in claim 7 refer to two different substances. Furthermore, this rejection can be obviated amending claim 7 to recite the phase “further comprising” instead of “comprising” to differentiate between the hydroxypropyl methyl cellulose recited in claim 1 and cellulose recited in claim 7. As such, Applicant’s argument is unpersuasive.
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, 8 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Wang et al. (CN 109260033 A, Jan. 25, 2019) (hereinafter Wang), as evidenced by SidleyChem (HydroxyPropyl MethylCellulose (HPMC), 2025) and Sigma-Aldrich, ((Hydroxypropyl)methyl cellulose, 2025).
Wang discloses a solid gargle particle (abstract). The solid gargle particle may comprise 0.05% to 2% hydroxypropyl methylcellulose, 10% xylitol (i.e., flavoring agent) (i.e., sweetening agent), 5% to 15% sorbitol (i.e. humectant) (page 3 of translation), and 0.5% to 5% sodium fluoride (i.e., functional additive) (i.e., anticaries agent) (page 4 of translation). Xylitol is a natural sweetener (page 4 of translation). Sodium fluoride is an anticaries agent (abstract). The solid gargle is used as follows: solid gargle granules are placed into the mouth, crushed, and then using the tongue the gums, teeth, and tongue are washed. A foam is discharged (i.e., foamable) and the mouth is rinsed with water several times (page 5 of translation).
Wang differ from the instant claims insofar as not disclosing 2.5-4 wt. % hydroxypropyl methyl cellulose.
However, Wang discloses 0.05% to 2% hydroxypropyl methylcellulose.
A prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. See MPEP 2144.05(I), wherein alloy having 0.8% nickel, 0.3% molybdenum, up to 0.1% iron, balance titanium is obvious over a reference disclosing alloys of 0.75% nickel, 0.25% molybdenum, balance titanium. Accordingly, since the claimed amount of 2.5% is so close to 2% disclosed by Wang, one of ordinary skill in the art would have expected them to have the same properties. Therefore, the claimed range comprising 2.5% would have been obvious.
In regards to instant claim 1 reciting a surface tension of the hydroxypropyl methyl cellulose in an aqueous solution at a concentration of 0.1 mass % is not greater than 56 mN/m, as evidenced by SidleyChem, hydroxypropyl methylcellulose has a surface tension of 42-56 dyn/cm for 2% aqueous solution and as evidenced by Sigma-Aldrich, hydroxypropyl methylcellulose has a surface tension of 43-55 dyn/cm at 0.05 wt. %. Accordingly, hydroxypropyl methylcellulose has a surface tension no greater than 56 mN/m at 0.1 mass%.
In regards to instant claims 8 and 9 reciting wherein the composition does not comprise a surfactant, a bacteriostatic agent, and a preservative, Wang does not disclose wherein the composition comprises or requires these components.
2. Claims 2-6 and 11-18 are rejected under 35 U.S.C. 103 as being unpatentable over Wang et al. (CN 109260033 A, Jan. 25, 2019) (hereinafter Wang) in view of Dogo-Isonagie et al. (US 2019/0167545, Jun. 6, 2019) (hereinafter Dogo-Isonagie).
The teachings of Wang are discussed above. Wang does not disclose wherein the solid gargle comprises 10-50% abrasive and 1-12% starch.
However, Dogo-Isonagie discloses a solid oral care composition, e.g., powder for the bleaching of tenacious teeth stains, such as tobacco stains and coffee stains (abstract). The composition may contain an abrasive, such as calcium carbonate in an amount of 10-90% (¶ [0020]). The composition may contain a disintegrating agent. Disintegrating agents include natural starches. Typical amounts of disintegrating agents are about 0.5% to about 20% (¶ [0022]).
Accordingly, it would have been prima facie obvious to one of ordinary skill in the art to have incorporated 10-90% calcium carbonate into the composition of Wang since abrasives are known and suitable carriers/excipients for solid oral compositions in particulate form as taught by Dogo-Isonagie.
Wang discloses wherein the solid gargle is crushed when used. Accordingly, it would have been prima facie obvious to one of ordinary skill in the art to have incorporated about 0.5% to about 20% natural starch into the composition of Wang motivated by the desire to aid in breaking up the solid gargle since natural starch is a disintegrating agent as taught by Dogo-Isonagie.
2. Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Wang et al. (CN 109260033 A, Jan. 25, 2019) (hereinafter Wang) in view of Dogo-Isonagie et al. (US 2019/0167545, Jun. 6, 2019) (hereinafter Dogo-Isonagie), and further in view of Boyd et al. (CN 101912350 A, Dec. 15, 2010) (hereinafter Boyd).
The teachings of Wang and Dogo-Isonagie are discussed above. Wang and Dogo-Isonagie do not disclose wherein the solid gargle comprises 5-30% lactobacillus fermentation compound.
However, Boyd discloses an oral care composition (abstract). The composition may be in the form of a tooth powder (¶ [0002]). The composition may comprise about 0.01 to about 12 wt. % lactic acid as a saliva stimulating agent. The saliva stimulating agent can be used for improving drying of the oral cavity (¶ [0070]).
Accordingly, it would have been prima facie obvious to one of ordinary skill in the art to have incorporated about 0.01 to about 12 wt. % lactic acid (i.e., lactobacillus fermentation compound) into the composition of Wang motivated by the desire to additionally treat dryness in the oral cavity as taught by Boyd.
3. Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Wang et al. (CN 109260033 A, Jan. 25, 2019) (hereinafter Wang) in view of Daniels et al. (US 2017/0071988, Mar. 16, 2017) (hereinafter Daniels).
The teachings of Wang are discussed above. Wang does not disclose wherein the solid gargle has a water activity of less than 0.75.
However, Daniels discloses mucoadhesive active granules with a water activity less than 0.1 (¶ [0091]).
Accordingly, it would have been prima facie obvious to one of ordinary skill in the art to have formulated the solid gargle particulates of Wang to have a water activity of less than 0.1 since this is a known and desirable physical property for solid oral particulates as taught by Daniels.
4. Claims 19 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Wang et al. (CN 109260033 A, Jan. 25, 2019) (hereinafter Wang) in view of Dogo-Isonagie et al. (US 2019/0167545, Jun. 6, 2019) (hereinafter Dogo-Isonagie), and further in view of Daniels et al. (US 2017/0071988, Mar. 16, 2017) (hereinafter Daniels).
The teachings of Wang and Dogo-Isonagie are discussed above. Wang and Dogo-Isonagie do not disclose wherein the solid gargle has a water activity of less than 0.75.
However, Daniels discloses mucoadhesive active granules with a water activity less than 0.1 (¶ [0091]).
Accordingly, it would have been prima facie obvious to one of ordinary skill in the art to have formulated the solid gargle particulates of Wang to have a water activity of less than 0.1 since this is a known and desirable physical property for solid oral particulates as taught by Daniels.
Response to Arguments
Applicant argues that Wang fails to teach the element “a content of the hydroxypropyl methyl cellulose in the composition is 2.5-4.0 weight %, based on the weight of the composition.”
The Examiner does not find Applicant’s argument to be persuasive. A prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. See MPEP 2144.05(I), wherein an alloy having 0.8% nickel, 0.3% molybdenum, up to 0.1% iron, balance titanium is obvious over a reference disclosing alloys of 0.75% nickel, 0.25% molybdenum, balance titanium. Accordingly, since the claimed amount of 2.5% is so close to 2% disclosed by Wang, one of ordinary skill in the art would have expected them to have the same properties. Therefore, the claimed range comprising 2.5% would have been obvious.
Applicant argues that the present inventor demonstrated with experimental data that exemplary compositions encompassed within the present claim 1 have foaming effect as compared to surfactant-containing toothpaste sold in the market, achieved a preservative effect using preservative-free toothpaste compositions, and have better safety as compared to surfactant-containing toothpaste.
The Examiner does not find Applicant’s argument to be persuasive. 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). In the instant case Wang is the closest prior art for the claimed invention to be compared to since Wang does not disclose a surfactant or a preservative. Since Applicant has not compared to the closest prior art, Applicant’s argument is unpersuasive.
Furthermore, even if Applicant’s showing is the closest prior art, Applicant’s showing would still be unpersuasive. It is not clear from Table 1 of the instant specification how each formulation has a different surface tension when it appears that each formulation comprises substantially the same ingredients in substantially the same amount. Also, it is not surprising that the composition in the showing achieved a reduction in bacteria after a number of days without a preservative since the composition in the showing comprises dicalcium phosphate, which is an alkalizing agent, and alkalizing agents neutralize acidic materials which generates bacteria. Moreover, Applicant has not shown wherein the claimed composition is better in safety. Applicant tested safety by seeing how long small fish would survive in a solution of the claimed composition compared with a surfactant-containing toothpaste solution. Evidence for unexpected results should establish that the differences in results are in fact unexpected and unobvious and of both statistical and practical significance. See MPEP 716/02(b). Toothpastes are used by humans. It is not clear how showing that fish can survive longer in the claimed toothpaste is of practical significance since fishes don’t live or use toothpastes. Applicant has not shown wherein the claimed composition is better in safety for humans. As such, Applicant’s argument is unpersuasive.
Applicants argues that the secondary references do not cure the deficiencies of Wang.
The Examiner submits that arguments regarding Wang have been addressed above and are unpersuasive. Therefore, all the rejections 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.
Claims 1-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No. 18/026,694 (reference application) 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 hydroxypropyl methyl cellulose. However, Gaserod discloses a gelled biopolymer-based foam for use in oral hygiene comprising a foaming agent (abstract) such as hydroxypropyl methyl cellulose (claim 3). Accordingly, it would have been obvious to one of ordinary skill in the art to have substituted methyl cellulose for hydroxypropyl methyl cellulose since it is another known and effective foaming agent as taught by Gaserod.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Applicant argues that the copending Application and Gaserod do not teach the claimed hydroxypropyl methyl cellulose content.
The Examiner disagrees. The copending Application discloses 0.1-10% methyl cellulose and, as discussed in the rejection, it would have been obvious to one of ordinary skill in the art to have substituted methyl cellulose for hydroxypropyl methyl cellulose since it is another known and effective foaming agent as taught by Gaserod. Therefore, the claimed hydroxypropyl methyl cellulose content is taught and Applicant’s argument is unpersuasive.
Applicant argues that the present inventor demonstrated with experimental data that exemplary compositions encompassed within the present claim 1 have foaming effect as compared to surfactant-containing toothpaste sold in the market, achieved a preservative effect using preservative-free toothpaste compositions, and have better safety as compared to surfactant-containing toothpaste.
The Examiner submits that this argument has been addressed above and is 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.
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.
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/TRACY LIU/Primary Examiner, Art Unit 1614