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 .
Applicants' arguments, filed July 8, 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 Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims
Claim Rejections - 35 USC § 103 – Obviousness (Revised)
Claims 1 and 4-6 are rejected under 35 U.S.C. 103 as being unpatentable over Chen (CN 105476936) in view of Yu et al. (CN 1044902) in further view of Johansen (US 6,100,080).
Chen discloses a high efficient stain-dispelling toothpaste, comprising 3 to 8 parts of a stain removing agent, and 2 to 6 parts of an enzyme preparation (Abstract). An embodiment is a toothpaste comprising 3 parts of enzyme preparation, 2 parts of tetrasodium pyrophosphate, 2 parts of sodium fluoride, 0.1 parts of sodium monofluorophosphate, 0.01 parts of calcium bisulfate, 3 parts of anhydrous silicon dioxide, 5 parts of wollastonite, 2 parts of sorbitol, 3 parts of sodium carboxymethyl cellulose, 3 parts of green tea extract, 2 parts of glycerol, 5 parts of xanthan gum, 2 parts of stevioside, 1 part of peppermint, 2 parts of water, 6 parts of strontium chloride, 1 part of paeonol, 1 part of thymol, 2 parts of asarum, 4 parts of herba schizonepetae, 2 parts of immunoglobulin, 1 part of sargent barberry bark extract, 3 parts of betelnut extractive, 2 parts of herba patriniae, 1 part of blackberry lily, 2 parts of garlic. Mannanase appears to be the only enzyme in the composition.
Chen differs from the instant claims insofar as it does not disclose that the composition stays in contact for about 5 minutes.
Yu et al. disclose a toothpaste for protecting the teeth and preventing caries. The composition comprises fluoride, carboxymethylcellulose, glycerol, an enzyme and a phosphate salt. The carboxymethyl cellulose amount ranges from 4 to 7% in order become the main carrier of the toothpaste. The toothpaste is brushed on the teeth. The paste creates a film on the teeth and is held on the teeth for 3 to 5 minutes. This leads to exerting its performance. Then the paste is rinsed off with water. The toothpaste is suitable for men, women, the old, the young. It is especially suitable for the kindergarten and primary school students.
Carboxymethyl cellulose is a thickening agent. One of ordinary skill in the art would reasonably conclude that by adding more carboxymethylcellulose, as taught by Yu et al., the thicker the toothpaste, and this would lead to the toothpaste staying on the teeth for a longer period of time.
Leaving the toothpaste on the teeth for a longer period of time would lead to a longer time the actives are in contact with the teeth. Therefore, it would have been obvious to one of ordinary skill in the art prior to filing the instant application to have formulated the toothpaste of Chen to remain on the teeth for 5 minutes in order to effectively deliver the enzyme to the teeth for a longer period of time to obtain its therapeutic effect.
It would also have been obvious to one of ordinary skill in the art prior to the filing of the instant application to have used the compositions on children teeth when the enzyme system of Chen et al. is used in the vehicle/composition of Yu et al. because these toothpastes are suitable for all ages.
Chen in view of Yu et al. is discussed above and discloses enzymes. It differs from the instant claims insofar as it does not explicitly disclose the type of mannanase.
Johansen disclose enzymatic treatment of biofilm. Biofilms are a severe problem in medical science and industry including dental plaque. Enzymes capable of biofilm degradation includes 1,4-β-D-mannan mannanohydrolase, α- D-mannoside mannohydrolase and β-D-mannoside mannohydrolase (beta-mannosidase). The one or more enzymes may be added to a composition. A method of treating the biofilm includes contacting the biofilm with a cleaning composition comprising one or more hydrolases, wherein the hydrolases include hemicellulases including mannanases (reference claims 1-2). The amount of hydrolase in the cleaning composition ranges from 0.01 to about 5000 micrograms protein/ml.
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. It would also have been obvious to one of ordinary skill in the art prior to the filing of the instant application to have used one of the mannanases of Johansen in the composition of Chen in view of Yu et al. because they are disclosed to disrupt biofilms. This would lead to the disruption of biofilms on the teeth.
It would also have been obvious to one of ordinary skill in the art prior to the filing of the instant application to have used the compositions on children teeth when the enzyme system of Chen et al. and Johansen are used in the vehicle/composition of Yu et al. because these toothpastes are suitable for all ages.
It would also have been obvious to one of ordinary skill in the art prior to the filing of the instant application to have added mannanase, as the enzyme, to the compositions of Yu et al. in order to obtain its therapeutic effect inhibiting tooth decay and biofilm.
In regards to the amount 0.05 units (0.016-0.025 microgram/mL) to 20 units (1.9 to 6.25 microgram/mL, the range overlaps that disclosed by Johansen, 0.01 to about 5000 micrograms protein/ml. It is well-settled, however, that even a slight overlap in range establishes a prima facie case of obviousness. See MPEP 2144.05. Accordingly, since an overlap plainly exists here, it would have been obvious to have selected values within the overlap, consistent with MPEP 2144.05. Therefore, it would have been obvious to one of ordinary skill in the art prior to filing the instant application to have used an amount within the gap because it is effective for disrupting biofilm.
Response to Arguments
The Examiner submits that it cannot be concluded that Chen does not disclose mannanase. However, to advance prosecution, it is concluded that Chen does not disclose mannanase. However, Johansen cures this deficiency as applied above. Johansen discloses using enzymes to treat biofilm. The enzymes may be used alone or in combination. Therefore, Johansen discloses using single enzymes and it would have been obvious to have used mannanase in the composition of Chen in view of Yu because it removes biofilms from the teeth. In regards to the alleged unexpected results, enzymes act on a specific substrate. Therefore, one would reasonably conclude that a specific enzyme targets a specific microbe or structure of a microbe. Further, the claims recite a composition for treating dental caries. They do not recite that the mannanase or composition has a specific mechanism to treat dental caries. Therefore, the combination of references meet the limitation of the instant claims.
Conclusion
Claims 1, 4-6 are rejected.
Claims 7-17 are withdrawn.
No claims 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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/LEZAH ROBERTS/Primary Examiner, Art Unit 1612
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