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 January 23, 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 Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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 (Maintained Rejections)
1) Claims 1, 3-5, 8, 16 and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Reynolds (WO 2016/101041, already of record) as evidenced by Vratny (GB 2138701).
Reynolds discloses mineralization fluoride compositions. The compositions are used for mineralizing hypomineralized lesions (including subsurface lesions) in the tooth enamel caused by various means including dental caries, dental corrosion and fluorosis. The compositions comprises a compound capable of maintaining the pH of a solution, calcium monofluorophosphate and a mineralizing agent . The mineralizing agent is preferably a stabilized amorphous calcium phosphate (ACP) and/or amorphous calcium fluoride phosphate (ACFP) (page 19, lines 8-15). The ACP or ACFP is in the form of a casein phosphopeptide stabilized ACP or ACFP complex. For oral compositions, it is preferred that the amount of the CPP-ACP and/or CPP-ACFP administered is 0.01 - 50% by weight of the composition. The amount of calcium monofluorophosphate is present in an amount of about 200 ppm to about 3000 ppm fluoride (F). The pH of the compositions is preferably maintained at about 7.5 (page 19, lines 13-19). The compositions may also comprise sodium fluoride. The method incudes the steps of contacting a dental surface with the composition (page 17, lines 10-15).
The compositions are used for mineralizing hypomineralized lesions (including subsurface lesions) in the tooth enamel and thereby, will reduce the visibility of a hypomineralized dental surface or subsurface.
In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art”, a prima facie case of obviousness exists. MPEP 2144.05 A. The instant claims recite at least 40% phosphopeptide stabilized amorphous calcium phosphate whereas the reference discloses 0.01 to 50%. However, it would have been obvious to one of ordinary skill in the art to have used amounts within the gap.
Response to arguments
In regards to Reynolds not disclosing how to make a composition comprising more than 40%, it would have been in the relative skill of one of ordinary skill in the art to have adjusted the conditions in order make a liquid with a higher concentration of active. Further, it has been disclosed in the art that careful stirring and gradual addition of a powder to a solvent avoids gel formation (see Vratny, GB 2138701, page 3, lines 9-19). Therefore, it would have been obvious to slowly add the powder of Reynolds to water to avoid gel formation. Further, in regards to the 45% solution, it was not disclosed how the solution was made in the instant specification. However, it would have been obvious to gradually stir in a large amount of powder when attempting to make a solution. One of skill in the art would take in consideration the solubility of the powder and adjust the condition accordingly. As stated above, one would want to avoid gelation or clumping when adding large amounts of powder to a solvent. Additionally, the claims do not specify how the concentrated solutions were made. It would be reasonable to conclude that a solution could also be made by concentrating a dilute composition with the slow evaporation of solvent. Therefore the rejection is maintained.
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2) Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Reynolds (WO 2016/101041, already of record) in view of Boskey (J. of Phys. Chem., 1973).
Reynolds is discussed above and differs from the instant claims insofar as it does not disclose the composition was heated when applied to the teeth.
Boskey teaches the effect of temperature on the rate of conversion of ACP to crystalline hydroxyapatite (Abstract; pg 2315, Figure 3). An “increase in temperature results in both a shortening of the induction time and an increase in the rate of crystal proliferation” (pg 2315, right column, first full paragraph). It is noted that the data displayed in Figure 3 of Boskey was obtained at pH 8. Heating the ACP to a temperature of 48 degrees C produces a more rapid onset, as well as an increased rate of crystallization to form hydroxyapatite from ACP, when compared with a temperature of 37 degrees C, the normal temperature of the mouth.
It would have been obvious to one of ordinary skill in the art prior to filing the instant application to have added the heated the composition of Reynolds and add the composition to the teeth in order to produce a more rapid onset, as well as increase the rate of crystallization to form hydroxyapatite on the teeth from ACP.
Response to Arguments
The Examiner submits that Reynolds is discussed above. Boskey cures the deficiencies of the instant claims by providing a reason to add heat. Therefore the rejection is maintained.
Response to Declaration
The Examiner submits that in regards to Reynolds not being enabling, Reynolds discloses the composition may comprise up to 50% of the stabilized ACP and/or ACFP and may be formulated into liquids. Although there is no exemplified method of make a liquid with the higher amount, one of ordinary skill in the through routine experimentation would be able to form a liquid with the higher amounts. Further, the claims do not recite controlling the pH while stirring in the powder into a liquid. Additionally it is not clear if the gelling or solidification of the Declaration would occur in other liquids encompassed by the instant claims. Even if the results of the Declaration were indeed persuasive, the claims are not commensurate in scope with the claims. The claims do not recite that the pH is held constant while mixing.
Obvious-Type Double Patenting (Maintained Rejection)
Claims 1, 3-5, 8-9, 16 and 23 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 2, 4, 10, 19, 31-32, 43, 49, 61, 64-65 and 67-72 of copending Application No. 17/438,272 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims are coextensive insofar as both sets of claims recite a method for mineralizing a dental surface. The instant claims differ from the copending claims insofar as they recite hypomineralizing and at least 40% of stabilized ACP whereas the copending claims recite mineralizing and gives a range of stabilized ACP. However the methods have the same end results and the amount overlap. 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.
Claims 1, 3-5, 8-9, 16 and 23 are rejected.
Claims 2, 24, 28-30, 34, 48, 52, 60, 67 and 70-71.
No claims allowed.
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/LEZAH ROBERTS/ Primary Examiner, Art Unit 1612