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 .
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 7/21/26 has been entered.
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.
Claim(s) 1 -8 remain rejected under 35 U.S.C. 103 as being unpatentable over Zegareilli (USP2009/0136893) in view of KR 20120090238 (English machine translation provided herewith).
Regarding claim 1, Zegareilli teaches:
A method, comprising:
positioning a substrate to receive a composition, the substrate forming at least a portion of a dental tray (Zegareilli: oral applicance 10; paras. 0034-0052; figs 1-3);
positioning by adhesion a composition (Zegareilli: porous material 18; paras. 0053-0111; figs 1-3) including a hydrophilic polymer (Zegareilli: paras. 0057-0060; figs 1-3) onto the substrate a surface of the substrate, the composition being a therapeutic composition adhered onto the substrate for delivery of the composition to teeth and/or oral tissue for treating an oral condition, the composition being in a gel state (Zegareilli: the porous material contains a therapeutic composition like whitening agent; the medicament/therapeutic composition that is impregnated within the injectionable porous material during the manufacturing of the porous material is in gel form thus allowing the porous material with medicament/therapeutic composition to be considered as being in a gel state; paras. 0075-0076); and
obtaining the substrate while substantially retaining the composition on the surface of the substrate (Zegareilli: the complete oral applicance has the porous material contained within the cargo areas of the oral appliance; paras. 0034-0052; figs 1-3).
However, Zegareilli does not teach positioning a mold relative to substrate; injecting a composition between the mold and the substrate and overmolding the composition onto the substrate; and separating the mold from the substrate.
KR 20120090238 teaches insert-injection molding within a mold an elastic body portion 40 of a mouthpiece onto a support portion 20 of the mouthpiece (figs 1-3). Further, KR 20120090238 teaches insert-injection molding is preferred over the conventional use of adhesives since adhesives can be harmful to the human body. Since Zegareilli and KR 20120090238 are analogous to mouthpieces, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to replace the use of the preformed porous material with medicant with/without adhesive of Zegareilli with the injection molding of the porous material with medicant onto the oral appliance as suggested by KR 20120090238 in order to eliminate the need for an adhesive, and improve process efficiency by reducing cycle time.
Regarding claim 2, such is taught by Zegareilli (Zegareilli: oral applicance 10; paras. 0034-0052; figs 1-3).
Regarding claim 3, such is taught by Zegareilli (Zegareilli: oral applicance 10; paras. 0034-0052; figs 1-3).
Regarding claim 4, such is taught by Zegareilli (Zegareilli: porous material 18; paras. 0053-0111; figs 1-3).
Regarding claim 5, such is taught by Zegareilli (Zegareilli: porous material 18; paras. 0053-0111; figs 1-3).
Regarding claim 6, Zegareilli does not teach using a gel form of the composition. The specific form a composition is a mere obvious matter of choice that is dependent on the desired final product and composition availability. Since gels with medicants are well-known in the mouthpiece/dental tray art, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to use a gel form of the porous material in the process of Zegareilli in order to diversify the product and control release of the medicants.
Regarding claim 7, Zegareilli teaches the porous material having hydrogen peroxide (Zegareilli: paras. 0053-0111; figs 1-3), but does not teach the claimed injection temperature. Molding temperature is well-known in the molding art as an important molding parameter and the desired temperature would have been obviously and readily determined through routine experimentation by one of ordinary skill in the art before the effective filing date of the invention. Further, the claimed temperature is generally well-known in the molding art and it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to inject the porous material of Zegareilli (modified) at the claimed temperature in order to form a high-quality product.
Regarding claim 8, such is taught by Zegareilli (Zegareilli: paras. 0075-0111; figs 1-3).
Claim(s) 9-16 remain rejected under 35 U.S.C. 103 as being unpatentable over Zegareilli (USP2009/0136893) in view of KR 20120090238 (English machine translation provided herewith).
Regarding claim 9, Zegareilli teaches:
A method, comprising:
positioning a dental tray to receive a porous material/composition (Zegareilli: oral applicance 10; paras. 0034-0052; figs 1-3), the oral treatment composition being in a gel state (Zegareilli: the porous material contains the oral treatment composition like whitening agent; the medicament/treatment composition that is impregnated within the injectionable porous material during the manufacturing of the porous material is in gel form thus allowing the porous material with medicament/treatment composition to be considered as being in a gel state; paras. 0075-0076);
positioning by adhesion a porous material/composition (Zegareilli: porous material 18; paras. 0053-0111; figs 1-3) including at least one therapeutic agent effective for treating an oral condition (Zegareilli: paras. 0057-0060; figs 1-3; ) onto one or both of the inner and outer sidewall of the dental tray (Zegareilli: porous material 18; paras. 0053-0111; figs 1-3).
However, Zegareilli does not teach positioning an overmolding mold to the dental tray; and overmolding the composition onto one or both of the inner and outer sidewall of the dental tray.
KR 20120090238 teaches insert-injection molding within a mold an elastic body portion 40 of a mouthpiece onto a support portion 20 of the mouthpiece (figs 1-3). Further, KR 20120090238 teaches insert-injection molding is preferred over the conventional use of adhesives since adhesives can be harmful to the human body. Since Zegareilli and KR 20120090238 are analogous to mouthpieces, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to replace the use of the preformed porous material with medicant with/without adhesive of Zegareilli with the injection molding of the porous material with medicant onto the oral appliance as suggested by KR 20120090238 in order to eliminate the need for an adhesive, and improve process efficiency by reducing cycle time.
Regarding claim 10, Zegareilli teaches at least one hydrophilic polymer (Zegareilli: paras. 0034-0052; figs 1-3) but does not teach using a gel form of the composition. The specific form a composition is a mere obvious matter of choice that is dependent on the desired final product and composition availability. Since gels with medicants are well-known in the mouthpiece/dental tray art, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to use a gel form of the porous material in the process of Zegareilli in order to diversify the product and control release of the medicants.
Regarding claim 11, such is taught by Zegareilli (Zegareilli: porous material 18; paras. 0053-0111; figs 1-3).
Regarding claims 12-13, the above combination of Zegareilli and KR 20120090238 teach the claimed steps of positioning; injecting; and separating. However, the above combination of Zegareilli and KR 20120090238 do not teach, retaining the dental tray in contact with the first mold. Since it is well-known in the insert molding art to retain a first molding within a first mold half and then overmold onto the first molding within the first mold, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to overmold the porous material of Zegareilli onto the molded dental tray held within its forming mold half in order to reduce molding complexity and time.
Regarding claim 14, such is taught by Zegareilli (Zegareilli: porous material 18; paras. 0053-0111; figs 1-3).
Regarding claim 15, Zegareilli does not teach the claimed injection temperature. Molding temperature is well-known in the molding art as an important molding parameter and the desired temperature would have been obviously and readily determined through routine experimentation by one of ordinary skill in the art before the effective filing date of the invention. Further, the claimed temperature is generally well-known in the molding art and it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to inject the porous material of Zegareilli (modified) at the claimed temperature in order to form a high-quality product.
Regarding claim 16, such is taught by Zegareilli since the porous material containing the therapeutic composition includes the claimed polymer (Zegareilli: paras. 0057-0060).
Claim(s) 21-24 remain rejected under 35 U.S.C. 103 as being unpatentable over Zegareilli (USP2009/0136893) in view of KR 20120090238 (English machine translation provided herewith).
Regarding claim 21, Zegareilli teaches:
A method, comprising:
positioning a substrate to receive a composition (Zegareilli: oral applicance 10; paras. 0034-0052; figs 1-3);
positioning by adhesion a composition (Zegareilli: porous material 18; paras. 0053-0111; figs 1-3) including a hydrophilic polymer (Zegareilli: paras. 0057-0060; figs 1-3) onto the substrate a surface of the substrate, the oral treatment composition being in a gel state (Zegareilli: the porous material contains the oral treatment composition like whitening agent; the medicament/treatment composition that is impregnated within the injectionable porous material during the manufacturing of the porous material is in gel form thus allowing the porous material with medicament/treatment composition to be considered as being in a gel state; paras. 0075-0076); and
obtaining the substrate while substantially retaining the composition on the surface of the substrate (Zegareilli: the complete oral applicance has the porous material contained within the cargo areas of the oral appliance; paras. 0034-0052; figs 1-3);
wherein the substrate is a dental tray including a trough defined by inner and outer sidewalls (Zegareilli: paras. 0034-0052; figs 1-3);
wherein the oral treatment composition is adhered onto at least a portion of one or both of the inner and outer sidewalls of the dental tray (Zegareilli: porous material 18; paras. 0053-0111; figs 1-3); and
wherein the oral treatment composition includes at least one therapeutic agent effective for treating an oral condition (Zegareilli: porous material 18; paras. 0053-0111; figs 1-3).
However, Zegareilli does not teach positioning a mold relative to substrate; injecting a composition between the mold and the substrate and overmolding the composition onto the substrate; and separating the mold from the substrate.
KR 20120090238 teaches insert-injection molding within a mold an elastic body portion 40 of a mouthpiece onto a support portion 20 of the mouthpiece (figs 1-3). Further, KR 20120090238 teaches insert-injection molding is preferred over the conventional use of adhesives since adhesives can be harmful to the human body. Since Zegareilli and KR 20120090238 are analogous to mouthpieces, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to replace the use of the preformed porous material with medicant with/without adhesive of Zegareilli with the injection molding of the porous material with medicant onto the oral appliance as suggested by KR 20120090238 in order to eliminate the need for an adhesive, and improve process efficiency by reducing cycle time.
Regarding claim 22, Zegareilli teaches the porous material having hydrogen peroxide (Zegareilli: paras. 0053-0111; figs 1-3).
Regarding claim 23, Zegareilli teaches the porous material being a liquid. (Zegareilli: paras. 0053-0111; figs 1-3).
Regarding claim 24, Zegareilli teaches the porous material including at least one hydrophilic polymer (Zegareilli: paras. 0053-0111; figs 1-3).
Applicant's arguments filed 7/21/26 have been fully considered but they are not persuasive.
Applicant argues Zegareilli does not teach the composition being in a gel,paste, or viscous state; however, this argument is misplaced since Zegareilli teaches the therapeutic composition/medicament is in gel form (Zegareilli: paras. 0075-0076).
Since the medicament/therapeutic composition that is impregnated within the injectionable porous material during the manufacturing of the porous material is in gel form, the porous material with medicament/therapeutic composition can be considered as being in a gel state.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. The following references teach molding a mouthpiece or dental tray: USPs 20120156648, 20100055639, 20070298380, 4553936, 8765031, and 10919209; and JPH06344380. USP20060029908 teaches using adhesive to attach a therapeutic composition to the trough of a dental tray.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to EDMUND H LEE whose telephone number is (571)272-1204. The examiner can normally be reached M-Th 9AM-4PM.
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EHL
/EDMUND H LEE/ Primary Examiner, Art Unit 1744
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