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 November 26, 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 Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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 (New Rejection)
Claims 1-4, 7-8, 11, 13, 15-22 and 25 are rejected under 35 U.S.C. 103 as being unpatentable over Rege et al. (WO 2017223292) in view of Doyle et al. (US 20070053849).
Rege et al. disclose oral care compositions comprising zinc phosphate and stannous fluoride (Abstract). The care composition is for intermittent use, e.g., daily use, in the form of a dentifrice, gel, lozenge, mint, chewing gum or other suitable oral care formulation. The oral care composition comprises zinc phosphate, stannous fluoride and water. The zinc phosphate may be added to the oral care composition as a preformed salt (paragraph 0014). The combination of zinc and stannous ions provides one or more of the following benefits: improved antimicrobial benefits compared to the zinc ions alone; improved control of plaque and/or gingivitis; improved protection against the erosion of tooth enamel (paragraph 0019). The amount of zinc phosphate used in the compositions ranges from 0.9 to 1.1% by weight, or about 1% by weight (paragraph 0015, 1.3). The amount of the stannous fluoride used in the compositions ranges from 0.4 to 0.5% by weight or about 0.45% (paragraph 0015, 1.4). An example is a dentifrice comprising 0.454% stannous fluoride, 1% zinc phosphate, 1.2% citrate buffer and 4% tetrasodium pyrophosphate (Example 5). Another example comprises 11. 74% water, 0.454% stannous fluoride, 1.15% zinc phosphate (“about” 1%), 3% trisodium citrate dihydrate and 0.60% citric acid (Example 4). The pH of the composition is from 6 to 9, such as from 6.5 to 8, or from 3 to 7 or from 4 to 7 or from 5 to 7, or from 5 to 6 (paragraph 0015, 1.19). The compositions of the can have any pH suitable for a product for use in oral care. Examples of suitable pH ranges are from 6 to 9, such as from 6.5 to 8 (paragraph 0042).
Rege et al. differ from the instant claims insofar as they do not disclose the organic acid buffer system.
Doyle et al. disclose compositions for treating diseases and conditions of the oral cavity. The conditions include gingivitis and periodontal disease (paragraph 0019). Antibacterial agents are used in the disclosed composition. The antibacterial agents preferred are those with selectivity for gram negative anaerobic bacteria involved in periodontal disease, such as P. gingivalis. P. gingivalis infects the gingival sulcus, producing a number of virulence factors including cysteine proteases known as gingipains. Gingipains act on several immune system molecules, including kinogens, complement factors, immunoglobins, resulting in fluid influx into the sulcus, neutrophil recruitment, and bleeding. Suitable antibacterial agents include zinc ion agents. The present compositions may contain a buffering agent. Buffering agents, as used herein, refer to agents that can be used to adjust the pH of the compositions to a range of about pH 3.0 to about pH 10. Suitable buffering agents include acetic acid, sodium acetate, citric acid, sodium citrate, benzoic acid and sodium benzoate. Buffering agents are used at a level of from about 0.1% to about 30%, preferably from about 1% to about 10%, and more preferably from about 1.5% to about 3%, by weight of the composition (paragraph 0099).
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 prior to filing the instant application to have used an acetic acid/acetate buffer in the composition of Rege et al. because they are suitable buffers to maintain the pH of an oral care composition.
In regards to the method of increasing protein that reduces signals associated with neutrophil recruitment, antibacterials treat P. gingivalis, which infects the gingival sulcus, producing a number of virulence factors including cysteine proteases known as gingipains. Gingipains act on several immune system molecules, including neutrophil recruitment. Antibacterials include zinc ions. The composition of Rege et al. is used to treat or prevent plaque and gingivitis. However, excess of bacteria biofilm (plaque) creates an inflammation state that recruits more immune cells, mainly neutrophils to the gingiva (as evidenced by Cortes-Vieyra, Abstract). Therefore, since the compositions are used to treat plaque and gingivitis, which is inflammation of the gingiva and zinc salts are used against P. gingivalis, 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 Rege et al. to increase protein that reduces signals associated with neutrophil recruitment because the zinc salt would act on P. gingivalis, which is associated with neutrophil recruitment.
The compositions would affect proteins present in the gingival crevice and comprise the required active components, zinc phosphate and stannous fluoride, in the required effective amounts. Therefore the composition of Rege et al. in view of Doyle et al. would act on TNFa and MIF.
In regards to the pH ranging from 4 to 5.5, in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. Rege teaches overlapping pH ranges as well as a range that encompasses the range of the instant claims, 4 to 7. In addition, Rege and Doyle teach the use of buffers like citrate and acetate. Therefore it would have been obvious to one of ordinary skill in the art prior to filing the instant application to have made the compositions of Rege et al. with a pH of 4 to 5.5 because this range falls withing the range disclosed by Rege et al.
Obvious-Type Double Patenting (Maintained Rejections)
1) Claims 1-4, 7-8, 11, 13, 15-22 and 25 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 and 9-10 of copending Application No. 17/309,895 (reference application). The rejection is maintained.
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims are coextensive insofar as they both recite methods of regulating proteins associated with neutrophils by applying a composition comprising a zinc salt and stannous fluoride. The instant claims differ from the copending claims insofar as the independent claim recites zinc phosphate and not zinc oxide and zinc citrate in the independent claim. However the instant claim do recited that an additional zinc salt may be added to the compositions and include zinc citrate and zinc oxide. Therefore the instant claims are obvious over the copending claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Applicants respectfully defer these issues until the application is otherwise in condition for allowance. Since this has not occurred, the rejection is maintained.
2) Claims 1-4, 7-8, 11, 13, 15-22 and 25 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of U.S. Patent No. 10,576,029. The Rejection is maintained.
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims are coextensive insofar as they recite a composition comprising stannous fluoride and zinc phosphate. The instant claims differ from the patented claims insofar as they recite a method and patented claims recite a composition. However, it would have been obvious to one of ordinary skill in the art to have used the compositions of the patented claims in the method of the instant claims because the instant claim use a composition comprising the same components as the compositions of the patented claims. Therefore the instant claims are obvious over the patented claims.
Response to Arguments
Applicants respectfully defer these issues until the application is otherwise in condition for allowance. Since this has not occurred, the rejection is maintained.
3) Claims 1-4, 7-8, 11, 13, 15-22 and 25 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-26 of U.S. Patent No. 11,395,791.
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims are coextensive insofar as they recite a method of using a composition comprising stannous fluoride, zinc phosphate and a buffer. The instant claims differ from the patented claims insofar as they recite a method if increasing protein that reduces signals associated with neutrophil recruitment and reducing protein that induces neutrophil recruitment within an individual’s gingival crevice whereas the patented claims recite a method of increasing sIgA and mucin 5B levels in an. However, it would have been obvious to one of ordinary skill in the art to have used the compositions of the patented claims in the method of the instant claims because the instant claim use a composition comprising the same components as the compositions used in the method of the patented claims. Therefore the instant claims are obvious over the patented claims.
Response to Arguments
Applicants respectfully defer these issues until the application is otherwise in condition for allowance. Since this has not occurred, the rejection is maintained.
Conclusion
Claims 1-4, 7-8, 11, 13, 15-22 and 25 are rejected.
No claims allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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