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 August 19, 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 Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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.
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 (Maintained Rejections)
1) Claims 1-4, 7-8, 11-12 and 14-15 are rejected under 35 U.S.C. 103 as being unpatentable over Eisfeld et al. (WO 0230376) as evidenced by Ross Organic (retrieved 2022) in view of Wolpo (US 20140093836).
Eisfeld et al. disclose aqueous dental cleaning agents consisting of particulate polishing agent components, humectants and surfactants. The surfactants contain a combination of anionic surfactants (A), non-ionic surfactants (N) and vegetable protein hydrolysates or their fatty acid (C12-C22) condensates. The protein hydrolysates or their fatty acid condensates in a quantity of 0.5-2.0 wt.- %, in relation to the total weight of the dental cleaning agent (Abstract). Protein hydrolysates include wheat protein (Gluadin® W20 and W40) and rice proteins (page 3, paragraph 5). Gluadin® W40 is a hydrolyzed wheat protein that is an amber liquid, with a characteristic inherent odor, a dry substance of 40.0-44.0%, a total nitrogen content of 5.2-6.5%, and an ash content of <= 1.5% (as evidenced by Ross Organic). The compositions comprise silica, humectants and antimicrobial agents. Other ingredients include those that act against tooth and gum disease such as sodium fluoride (instant claim 7). Buffers are used and include primary, secondary and tertiary alkali phosphate buffers (page 4, paragraphs 7-11). The composition kill bacteria, which would inhibit white spots. The compositions may be formulated into aqueous, pasty or liquid dispersions (meeting mouthwash) (page 2 paragraph 2). The tooth cleaning agents are primarily intended to clean the tooth surface from food residues, discolorations caused by, e.g., tobacco or tea and support, and inhibiting plaque (page 2, paragraph 3). This would encompass a cosmetic method as recited by instant claim 14. This would also encompass reducing the incidence of white spots.
Gluadin® W40 is the same hydrolyzed wheat protein used in the instant claims. Therefore it is concluded that the Gluadin® W40 of Eisfeld et al. would have the molecular weight distribution of the instant claims.
Eisfeld et al. differ from the instant claims insofar as they do not disclose identifying a patient population.
Wolpo discloses oral hygiene systems for cleaning the teeth and gums. The system removes plaque, which causes white-spot lesions, dental caries and gingivitis (paragraph 0002).
In regards to identifying a patient, a patient having plaque would be susceptible to white spots because white spots may be caused by plaque. This would meet the limitation of a identifying a patient in need of reducing the incidence of white spot lesions. The compositions of Eisfeld et al. are used to clean the teeth, which would remove plaque and reduce the incidence of white spots lesions. Therefore it would have been obvious to one of ordinary skill in the art prior to filing the instant application to have used the composition of Eisfeld et al. to reduce the incidence of white spots on a patient identified as having plaque (which leads to white spots) because the composition clean the teeth, thereby removing plaque. This would lead to the reduction of incidence of white spot lesions.
The composition are used to clean the teeth and therefore are applied to the teeth of the patient in an effective amount.
Response to Arguments
The Examiner submits that Wolpo discloses using the disclosed composition can treat plaque, and that plaque can cause white-spot lesions, dental caries and gingivitis. As applicant argues in response to the New Matter rejection, it does not have to be explicitly disclosed that a patient is identified to meet the limitation of identifying a patient. In the instant case, the condition of treating plaque that can cause white-spot lesions implicitly indicates that a patient has been identified to need such treatment. Therefore, Wolpo alone and in combination with Eisfeld identifies a patient for the specific purpose of treating, mitigating, and/or reducing the incidence, size or visibility of white spot lesion. In regards to the method, treating plaque would lead to reducing the incidence, size or viability of white lesions. Therefore the rejection is maintained.
2) Claims 1-4, 7-9, 11-12 and 14-15 are rejected under 35 U.S.C. 103 as being unpatentable over Nakajima et al. (JP2008074774) in view of Eisfeld et al. (WO 0230376) as evidenced by Ross Organic (retrieved 2022) in further view of Wolpo (US 20140093836).
Nakajima et al. disclose oral compositions comprising a zinc compound and a protein hydrolysate derived from soybean or wheat. The compositions are used to control tartar (tartar is formed from plaque) from forming on the teeth. The wheat includes wheat gluten and has a molecular weight of 700 (Promois WG with additives methylparaben, propylparaben and butylene glycol (preservatives)) (paragraph 0021). The protein hydrolysate may comprise 1 to 4% by weight of the composition (Abstract). The molecular weight of the protein hydrolysates range from 300 to 4,000, preferably 500 to 2,000 (paragraph 0018). Other components may be used and include various medicinal ingredients (paragraph 0027). The compositions may be formulated in to mouthwashes. A mouthwash comprises purified water, a water-soluble zinc compound, sodium fluoride, sodium monofluorophosphate, sodium saccharin, xylitol and glycerin (paragraph 0040). The mouthwash of Example 10 comprises 1% of wheat hydrolyzed protein, 0.05 sodium fluoride (225 ppm) and 75.34 % water. The mouthwash does not comprise polishing agents. Another example of a mouthwash comprises 0.2% sodium monofluorophosphate, which is 263 ppm F (Example 11). The mouthwash compositions may also comprise a fragrance (paragraph 0044). Humectants comprise 1 to 50% and include glycerin, sorbitol, propylene glycol, xylitol and polyethylene glycol (paragraph 0031). Surfactants may be used and include nonionic surfactants (paragraph 0029). The compositions may comprise ethanol.
Nakajima et al. differ from the instant claims insofar as they do not disclose the molecular weight distribution of the instant claims.
Eisfeld et al. disclose aqueous dental cleaning agents consisting of particulate polishing agent components, humectants and surfactants. The surfactants contain a combination of anionic surfactants (A), non-ionic surfactants (N) and vegetable protein hydrolysates or their fatty acid (C12-C22) condensates. The protein hydrolysates or their fatty acid condensates in a quantity of 0.5-2.0 wt.- %, in relation to the total weight of the dental cleaning agent (Abstract). Protein hydrolysates include wheat protein (Gluadin® W20 and W40) and rice proteins (page 3, paragraph 5). Gluadin® W40 is a hydrolyzed wheat protein that is an amber liquid, with a characteristic inherent odor, a dry substance of 40.0-44.0%, a total nitrogen content of 5.2-6.5%, and an ash content of <= 1.5% (as evidenced by Ross Organic). The compositions comprise silica, humectants and antimicrobial agents. Other ingredients include those that act against tooth and gum disease such as sodium fluoride (instant claim 7). Buffers are used and include primary, secondary and tertiary alkali phosphate buffers (page 4, paragraphs 7-11). The composition kill bacteria, which would inhibit white spots. The compositions may be formulated into aqueous, pasty or liquid dispersions (meeting mouthwash) (page 2 paragraph 2). The tooth cleaning agents are primarily intended to clean the tooth surface from food residues, discolorations caused by, e.g., tobacco or tea and support, and inhibiting plaque (page 2, paragraph 3). This would encompass a cosmetic method as recited by instant claim 14. This would also encompass reducing the incidence of white spots.
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 have been obvious to one of ordinary skill in the art at the time the invention was made to have used Gluadin® W40 as the hydrolyzed wheat protein in the compositions of Nakajima et al. because it is a suitable hydrolyzed proteins for use in oral care compositions.
Gluadin® W40 is the same hydrolyzed wheat protein used in the instant claims. Therefore it is concluded that Gluadin® W40 would have the molecular weight distribution of the instant claims.
Nakajima et al. in view of Eisfeld et al. differs from the instant claims insofar as they do not disclose identifying a patient population.
Wolpo discloses oral hygiene systems for cleaning the teeth and gums. The system removes plaque, which causes white-spot lesions, dental caries and gingivitis (paragraph 0002).
In regards to identifying a patient, a patient having plaque would be susceptible to white spots because white spots may be caused by plaque. This would meet the limitation of a identifying a patient in need of reducing the incidence of white spot lesions. The compositions of Nakajima et al. in view of Eisfeld et al. are used to inhibit calculus formation on the teeth, which would inhibit plaque and white spots. Therefore it would have been obvious to one of ordinary skill in the art prior to filing the instant application to have used the composition of Nakajima et al. in view of Eisfeld et al. to reduce the incidence of white spots on the teeth a patient identified as having plaque (which leads to white spots) because the composition clean the teeth, thereby removing plaque. This would lead to the reduction of incidence of white spot lesions.
The composition are used to clean the teeth and therefore are applied to the teeth of the patient in an effective amount.
Response to Arguments
The Examiner submits that Nakajima discloses a molecular weight ranging from 300 to 4000, which would encompass about 65%<3500D and about 84-92% < 6000D. The amounts above this may be as little as 1%. One of ordinary skill in the art would recognize that the hydrolyzed wheat protein of Nakajima would have close to the same properties as that of Eisfeld because the majority of the protein is substantially the same as that of Nakajima, less than 6000D. Therefore one of ordinary skill in the art would be motivated to use the protein of Eisfeld in the composition of Nakajima. In regards to identifying the patient, the argument submitted above applies here. Eisfeld discloses that the composition may be used to treat a certain condition, plaque that leads to white lesions. Therefore, a patient population has been identified because the composition is used to treat plaque, which would be plaque on the teeth of a patient. Therefore, the rejection is maintained.
3) Claims 1-15 are rejected under 35 U.S.C. 103 as being unpatentable over Nakajima et al. (JP2008074774) in view of Eisfeld et al. (WO 0230376) and Wolpo (US 20140093836) in further view of Vermeer (US 5,624,906).
Nakajima et al. in view of Eisfeld et al. and Wolpo is discussed and differs from the instant claims insofar as it does not disclose cetylpyridinium chloride and a buffer.
Vermeer disclosed composition that may be formulated into mouthwashes. The mouthwash and dental rinse compositions are preferably liquids based predominantly on water. Therapeutic mouthwashes are formulated for the purpose of relieving infection, preventing dental caries, or mitigating some other pathological condition that may be associated with the mouth, teeth or throat (col. 1, lines 62-65). Water general comprises 45% to about 90% by weight of the composition. Fluoride may be included and typical levels of fluoride are from about 0% to about 5% by weight of the composition. Flavors are used and typical levels of flavor oil are from about 0.01% to about 4% by weight of the composition. Antibacterial agents include cetylpyridinium chloride and comprise 0 to about 5% by weight of the composition. Surfactants include nonionic surfactant. Anionic surfactants include hydrolyzed protein from wheat gluten. Typical levels of surfactant are about 0.02% to about 25% by weight of the composition. Examples of humectants useful in the present invention which serve to add body or mouth feel to a mouthwash or dental rinse composition and retain moisture in a dentifrice composition include polyethylene glycol, propylene glycol (PG), glycerol (glycerin), erythritol, xylitol, sorbitol, mannitol, hydrogenated starch hydrolysates and mixtures thereof. Typical levels of humectant are from about 0% to about 80% by weight of a composition. Alcohol does not have to be present. Typical levels of sweetener are from about 0.01% to about 4% by weight of the composition. Buffers are used to adjust the pH. The pH ranges from about 3 to about 8 (col. 36, lines 39-50). Compositions may comprise sodium triphosphate.
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 have been obvious to one of ordinary skill in the art at the time the invention was made to have used cetylpyridinium chloride and a phosphate buffer in the compositions of Nakajima et al. to use in a method of reducing the incidence, size or visibility of white lesions on teeth to obtain their therapeutic function as an antibacterial agent pH adjusting agent.
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to have used the compositions of Nakajima et al. in view of Eisfeld et al. and Wolpo to reduce the incidence, size or visibility of white lesions on teeth because the compositions comprise agents that would remove plaque and therefore would reduce the incidence of white spot lesions of the teeth.
The composition are used to clean the teeth and therefore are applied to the teeth of the patient in an effective amount.
Response to Arguments
The Examiner submits that Vermeer cures the deficiencies of the instant claims by disclosing cetylpyridinium chloride. Therefore based on the arguments above, the rejection is maintained.
Obvious-Type Double Patenting (Maintained Rejections)
1) Claims 1-15 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4, 6-11, 14 and 16-19 of copending Application No. 15/771,258 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because they are coextensive insofar as they both recite compositions comprising a partially hydrolyzed protein in an oral care composition. The instant claims differ from the copending claims insofar as the instant claims recite a method and the copending claims recite a composition and a method. However it would have been obvious to one of ordinary skill at the time the applications were filed to have used the compositions of the copending claims in the method of the instant claims because the composition of the copending claims and the composition used in the method of the instant claims are oral care compositions comprising a partially hydrolyzed protein.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
The Examiner submits that the molecular weight of the copending application encompass the range of the instant claims. Therefore, this rejection is maintained and neither allowable subject matter has been indicated, nor has a terminal disclaimer been filed.
2) Claims 1-15 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 and 15-21 of copending Application No. 15/771,246 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because they are coextensive insofar as they both recite compositions comprising a partially hydrolyzed protein in an oral care composition. The instant claims differ from the copending claims insofar as the instant claims recite a method and the copending claims recite a composition and a method. However it would have been obvious to one of ordinary skill at the time the applications were filed to have used the compositions of the copending claims in the method of the instant claims because the composition of the copending claims and the composition used in the method of the instant claims are oral care compositions comprising a partially hydrolyzed protein.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
The Examiner submits that the molecular weight of the copending application encompass the range of the instant claims. Therefore, this rejection is maintained and neither allowable subject matter has been indicated, nor has a terminal disclaimer been filed.
Conclusion
Claims 1-15 are rejected.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LEZAH ROBERTS whose telephone number is (571)272-1071. The examiner can normally be reached Monday-Friday 11:00-7:30.
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/LEZAH ROBERTS/Primary Examiner, Art Unit 1612