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 .
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 (Zegareilli: the porous material that contains therapeutic composition like whitening agent; paras. 0006-0007; 0052; 0057-0060; and 0079; figs 1-3); 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);
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; 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 12/12/25 have been fully considered but they are not persuasive.
Applicant argues there is no teaching, suggestion, motivation, or reasoning that the porous material with medicant of Zegareilli could be injection molded or “double injection” to attach the porous material with medicant to the oral appliance of Zegareilli. This argument is misplaced since Zegareilli teaches combining the medicant with the porous material during the injection molding of the porous material (paras. 0056 and 0076); and using an adhesive to connect the porous material to the oral appliance (para. 0052). Since KR 20120090238 teaches injection molding a sleeve onto a mouthpiece, i.e. overmolding a layer onto a preform, is advantageous over the conventional method of adhesively bonding a preformed sleeve onto a mouthpiece, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to replace the adhesive bond between the preformed porous material with medicant of Zegareilli and the oral applicance of Zegareilli with the overmolding process taught by KR 20120090238 in order to eliminate the need for an adhesive that can be harmful for humans, and improve process efficiency by reducing cycle time. It should be noted that both Zegareilli and KR 20120090238 teach using ABS, as one example, as the polymer for both the porous material/sleeve and oral appliance/injection molded elastic body, which implies the inherent bonding or fusing between the materials. Also, it is reminded that Zegareilli teaches the porous material with medicant is injectionable since it can be formed by injection molding (para. 0056).
Applicant argues the one skilled in the art would not have combined Zegareilli and KR 20120090238 because they perform different function, in different ways, to obtain different results. Applicant is reminded that the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981). Here, one of ordinary skill in the art before the effective filing date of the invention would have found it obvious to overmold as taught by KR 20120090238 the porous material with medicant of Zegareilli onto the oral appliance of Zegareilli instead of using an adhesive as taught by Zegareilli in order to eliminate any harmful controversy to the human body that can come from using an adhesive. It is reminded that explicitly teaches using an overmolding process, double-injectioning, is advantageous over using an adhesive since using an adhesive exposes the human body to harmful controversy (para. 0020: “In this case, the thermal fusion of the main body 20 and the elastic body 40 in the present invention refers to a form that is attached to the main body 20 while the elastic body 40 is molded by heat during injection molding. Of course, the attachment for the integration of the main body 20 and the elastic body 40 can be achieved through other methods, but this is because there is a concern of improved cost and harmful controversy to the human body by applying a separate processing or adhesive, Was proposed to heat-bond the main body 20 and the elastic body 40 through the double injection.”).
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.
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 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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