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 in the Request for Continued Examination, filed March 20, 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 Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Revised Rejection
1) 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) as evidenced by Baillie (Diseases, Conditions, Syndromes, 2017), Puracy (Mannanase, 2020) and Geocon, (retrieved March 30, 2026).
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 is 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.
The composition comprises mannanase, which breaks down mannan. Mannan contributes to biofilm leading to childhood tooth decay. Mannanase breaks down mannans, which contributes to adherence of biofilm to the teeth and causes childhood tooth decay (as evidenced by Baillie, K. and Puracy). Therefore, it would disrupt the formation of a biofilm and be effective in treating dental caries. 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 mannanase 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 added mannanase, as the enzyme, to the compositions of Yu et al. in order to obtain its therapeutic effect inhibiting tooth decay.
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 toothpaste are suitable for all ages.
In regards to the amount of enzyme in Units, the Units represent the enzymatic activity. Therefore, it is a result effective variable. It would have taken no more than the relative skill of one of ordinary skill in the art to have adjusted the amount of enzyme to reach the desire enzymatic activity. Therefore, the instantly claimed range of 0.05 U to about 20 U is obvious over that of Chen.
In regards to the mannanase being a beta mannanase, a synonym for mannanase includes beta-mannosidase. When mannanase is used, it refers to the beta form (as evidenced by Geocon, retrieved March 30, 2026). Therefore, the mannanase of Chen would meet the limitation of a beta-mannanase.
Response to Augments
The Examiner submits that mannanase is a synonym for beta-mannanase. Therefore the composition of the combined references teach beta-mannanase.
New Rejections
2) Claims 1 and 5-6 are rejected under 35 U.S.C. 103 as being unpatentable over Chen (CN 105476936) as evidenced by Baillie (Diseases, Conditions, Syndromes, 2017), Puracy (Mannanase, 2020) and Geocon, (retrieved March 30, 2026).
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 is the only enzyme in the composition.
In regards to the amount of enzyme in Units, the Units represent the enzymatic activity. Therefore, it is a result effective variable. It would have taken no more than the relative skill of one of ordinary skill in the art to have adjusted the amount of enzyme to reach the desire enzymatic activity. Therefore, the instantly claimed range of 0.05 U to about 20 U is obvious over that of Chen. See MPEP 2144.05.
In regards to the mannanase being a beta mannanase, a synonym for mannanase includes beta-mannosidase. When mannanase is used, it refers to the beta form (as evidenced by Geocon, retrieved March 30, 2026). Therefore, the mannanase of Chen would meet the limitation of a beta-mannanase.
In regards to disrupting biofilm, the composition comprises mannanase. Therefore, one of ordinary skill in the art would reasonably conclude that the composition would perform this function.
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, making it a result effective variable. 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 mannanase to the teeth for a longer period of time to obtain its therapeutic effect. See MPEP 2144.05.
3) 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) as applied above in further view of Johansen (US 6,100,080).
Chen in view of Yu et al. is discussed above and discloses mannanase, which would encompass the mannanase recited by instant claim 2. However, purely arguendo, 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. is used in the vehicle/composition of Yu et al. because these toothpaste are suitable for all ages.
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.
Conclusion
Claims 1, 4-6 are rejected.
Claims 7-17 are withdrawn.
No claims allowed.
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/LEZAH ROBERTS/Primary Examiner, Art Unit 1612