DETAILED ACTION
Claim Rejections - 35 USC § 103
1. 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.
2. Claims 1, 3, 4, 7-9, 11, 12, 15-17 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Knipfer et al, U.S. Patent Application Publication No. 2010/0274309 (hereinafter Knipfer) in view of Duggan, U.S. Patent No. 4,481,950 (hereinafter Duggan).
Regarding claim 1, Knipfer discloses an implantable medical device (from abstract, see Described herein is an implantable medical device and methods for making a device that includes a metal housing a molding process), the device comprising:
a metal case (from paragraph 0004, see Described herein is an implantable medical device that includes a metal housing having a first portion, second portion, a header attachment element and an electronics package configured to be disposed within the housing, in one embodiment);
a mold layer internal to the metal case and including a molded cavity arranged next to the metal case (from paragraph 0073, see As used herein, the term "molding" refers to a process of manufacturing in which a pliable raw material is shaped using a pattern or mold having a desired size and shape. Typically, the mold defines a cavity that is configured to receive a flowable material such as a liquefied or molten metal or metal alloy. After the flowable material is introduced into the mold, it is allowed to harden and adopt the shape of the mold. After the material hardens, the final product is removed from the mold. Many molding processes are known and include, but are not limited to: injection molding, compression molding, transfer molding, extrusion molding, rotational molding, and the like. Briefly, in an injection molding process, the flowable material is forced into a mold cavity where it cools and hardens to the configuration of the mold cavity. In a compression molding process, the molding material is generally placed in an open mold cavity which is then closed with a top force or plug member and pressure is applied to force the material into contact with all mold areas. In a transfer molding process, the molding material is preheated and loaded into a chamber. A plunger is then used to force the material from the chamber through channels known as a sprue and runner system into the mold cavities. The mold remains closed as the material is added and is opened to release the molded component. In an extrusion molding process, the material is heated and then loaded into a die or container. A ram then presses the material to push it out of the die. In a rotational molding process the mold is slowly rotated (usually around two perpendicular axes) causing the material to flow into to the mold and adhere to the walls of the mold); and
a component arranged between the metal case and the molded cavity of the mold layer, wherein the component contacts the metal case (from paragraph 0003, see Implantable medical devices (IMDs) are commonly used to provide treatment to patients. Implantable medical devices can include cardiac rhythm management (CRM) devices, including pacemakers and Implantable Cardioverter Defibrillators (ICDs). In general, CRM devices deliver electrical stimuli to a target tissue via a lead wire having one or more electrodes disposed in or about the target tissue. The lead wire is typically connected to a pulse generator contained within a housing. In addition to the pulse generator, the housing can also contain other system components. Typically, the housing is formed by stamping the desired shaped components from a sheet of metal).
Still on the issue of claim 1, Knipfer does not teach the component is a piezo speaker. All the same, Duggan discloses the component is a piezo speaker (from abstract, see A piezoelectric element positioned adjacent the inside wall of the implantable device is selectively energized by an oscillator circuit operating from an energy storage capacitor). Therefore, it would have been obvious to one of ordinary skill in the art to modify Knipfer wherein the component is a piezo speaker as taught by Duggan. This modification would have improved the system’s efficiency by providing a means for transmitting data from within the implanted device to be received and sensed outside the body as suggested by Duggan.
Regarding claim 3, the combination of Knipfer and Duggan discloses the mold layer includes a ridge around the molded cavity (from paragraph 0036 of Knipfer, see Similarly, the second portion 230 includes substantially parallel opposing inner 232 and outer 231 surfaces and is configured to enclose the cavity 227 defined by the first portion 220 when the housing 200 is assembled. In one embodiment, the second portion 230 includes one or more sidewalls 250b extending from the top 235. In one embodiment, the sidewalls 250b of the second portion 230 generally mirror the shape of the first portion 220 sidewalls 250a such that the one or more second portion 230 sidewalls 250b are configured to mate with the first portion 220 sidewalls 250a when the housing 200 is assembled. The sidewalls 250b of the second portion 230 terminate in a peripheral edge 266 disposed between the inner 232 and outer 231 surfaces of the sidewall 250b. In one embodiment, the second portion 230 sidewalls 250b have a height that is less than the height of the first 220 portion sidewalls 250a. In another embodiment, the second portion 230 sidewalls 250b have a height that is greater than the height of the first 220 portion sidewalls 250a. As used in the context of the first portion 220 sidewall 250a, the term "height" refers to the shortest linear distance between the top (or plane defined by the top) surface 225 of the housing 200 to the peripheral edge 265 of the sidewall 250a. Similarly, as used in the context of the second portion 230 sidewall 250b, the term "height" refers to the shortest linear distance between the base (or plane defined by the base) surface 235 of the housing 200 to the peripheral edge 266 of the sidewall 250b. In another embodiment, the second portion 230 sidewalls 250b have a height that is substantially the same as the first portion 220 sidewalls 250a. In an alternate embodiment (not shown), the second portion 230 does not include a sidewall, but rather includes a protrusion extending from the interior surface 232 of the top 235 that is spaced from the edge of the second portion 230 and follows the perimeter of the second portion 230. In this embodiment, the first portion 220 sidewall 250a is configured to physically overlap and rest externally to the protrusion such that the peripheral edge 265 of the first portion 220 engages the interior surface 232 of the top 235 when the housing 200 is assembled) and the piezo speaker (from abstract of Duggan, see A piezoelectric element positioned adjacent the inside wall of the implantable device is selectively energized by an oscillator circuit operating from an energy storage capacitor) contacts the ridge.
Regarding claim 4, the combination of Knipfer and Duggan discloses an insulating layer (from column 5 of Duggan, see A plastic insulating layer 57 is sandwiched between the top of transducer 22 and inner partition 53 for purposes of electrical insulation. In case a separate inner partition 53 is not used, plastic layer 57 would insulate the transducer from the battery case itself) around the piezo speaker except for a portion of the piezo speaker that contacts the ridge.
Regarding claim 7, the combination of Knipfer and Duggan discloses the piezo speaker includes a piezo element (from column 5 of Duggan, see Referring now to FIGS. 3 and 4, the transducer used in the preferred embodiment of the invention, and its mounting in a pacemaker housing are shown. The preferred transducer as shown in FIG. 3 is a ceramic piezoelectric element. It comprises a generally circular brass disc or plate 40, on top of which is bonded a ceramic piezoelectric element indicated by reference number 41. Brass disc 40 serves as one electrode for the transducer, and a metalized layer is formed on top of piezoelectric element 41 to serve as the other electrode. In FIG. 3, the metalized layer electrode is indicated by reference number 42. A zone of layer 42 is cut away to provide separation for a separate tab or finger portion indicated by reference number 43. This tab is also made of the metalized electrode layer in contact with the underlying ceramic piezoelectric element, but it is electrically separate from electrode portion 42, so as to provide a feedback electrode. Electrical connections are made via brass disc 40, and an electrical conductor 44 which is soldered to electrode 42, and conductor 45 which is soldered to electrode 43) contacting a metal substrate; and wherein the device further includes an insulating layer (from column 5 of Duggan, see A plastic insulating layer 57 is sandwiched between the top of transducer 22 and inner partition 53 for purposes of electrical insulation. In case a separate inner partition 53 is not used, plastic layer 57 would insulate the transducer from the battery case itself) covering the metal substrate and the piezo element.
Regarding claim 8, the combination of Knipfer and Duggan discloses the metal substrate includes a brass disk, the piezo element includes a piezoelectric ceramic (from column 5 of Duggan, see Referring now to FIGS. 3 and 4, the transducer used in the preferred embodiment of the invention, and its mounting in a pacemaker housing are shown. The preferred transducer as shown in FIG. 3 is a ceramic piezoelectric element. It comprises a generally circular brass disc or plate 40, on top of which is bonded a ceramic piezoelectric element indicated by reference number 41. Brass disc 40 serves as one electrode for the transducer, and a metalized layer is formed on top of piezoelectric element 41 to serve as the other electrode. In FIG. 3, the metalized layer electrode is indicated by reference number 42. A zone of layer 42 is cut away to provide separation for a separate tab or finger portion indicated by reference number 43. This tab is also made of the metalized electrode layer in contact with the underlying ceramic piezoelectric element, but it is electrically separate from electrode portion 42, so as to provide a feedback electrode. Electrical connections are made via brass disc 40, and an electrical conductor 44 which is soldered to electrode 42, and conductor 45 which is soldered to electrode 43), and the insulation layer includes polymide (from column 5 of Duggan, see Transducer 22 is mounted to the inside of lower wall 52. Specifically, brass disc 40 may be secured to wall 52 by a suitable adhesive, or by welding. Adhesive bonding can be accomplished by coating the entire surface of the disc with Eastman 910 adhesive, for example. A plastic insulating layer 57 is sandwiched between the top of transducer 22 and inner partition 53 for purposes of electrical insulation. In case a separate inner partition 53 is not used, plastic layer 57 would insulate the transducer from the battery case itself).
Regarding claim 9, Knipfer discloses a method of forming a mechanism of an implantable medical device (from abstract, see Described herein is an implantable medical device and methods for making a device that includes a metal housing a molding process), the method comprising:
forming a metal case (from paragraph 0004, see Described herein is an implantable medical device that includes a metal housing having a first portion, second portion, a header attachment element and an electronics package configured to be disposed within the housing, in one embodiment);
forming a mold layer including a molded cavity (from paragraph 0073, see open mold cavity which is then closed with a top force or plug member and pressure is applied to force the material into contact with all mold areas);
arranging the mold layer in the metal case with the molded cavity arranged to a wall of the metal case (from paragraph 0004, see Described herein is an implantable medical device that includes a metal housing having a first portion, second portion, a header attachment element and an electronics package configured to be disposed within the housing, in one embodiment. The first portion includes a base and one or more sidewalls, each with an interior surface and an exterior surface, wherein the interior surfaces of the base and sidewalls define a cavity. The second portion is configured to enclose the cavity defined by the first portion when the housing is assembled. The header attachment element extends from the first or second portion of the housing, and includes a header attachment surface with one or more header attachment structures configured to mate with a connector header. In one embodiment, the header attachment element is integrally molded with the first or second portion of the housing. In another embodiment, the implantable medical device includes a header attachment surface comprising one or more header retaining features configured to secure a connector header to the header attachment surface. In one embodiment, one or more header retaining features include a handle-shaped projection. In another embodiment, the housing includes one or more structural elements extending from and integrally molded with the interior surface of the first or second portions of the housing. Also disclosed are methods of making the implantable medical device); and
arranging a component between the metal case and the molded cavity of the mold layer, wherein the component contact the metal case (from paragraph 0003, see Implantable medical devices (IMDs) are commonly used to provide treatment to patients. Implantable medical devices can include cardiac rhythm management (CRM) devices, including pacemakers and Implantable Cardioverter Defibrillators (ICDs). In general, CRM devices deliver electrical stimuli to a target tissue via a lead wire having one or more electrodes disposed in or about the target tissue. The lead wire is typically connected to a pulse generator contained within a housing. In addition to the pulse generator, the housing can also contain other system components. Typically, the housing is formed by stamping the desired shaped components from a sheet of metal).
Still on the issue of claim 9, Knipfer does not teach the component is a piezo speaker. All the same, Duggan discloses the component is a piezo speaker (from abstract, see A piezoelectric element positioned adjacent the inside wall of the implantable device is selectively energized by an oscillator circuit operating from an energy storage capacitor). Therefore, it would have been obvious to one of ordinary skill in the art to modify Knipfer wherein the component is a piezo speaker as taught by Duggan. This modification would have improved the system’s efficiency by providing a means for transmitting data from within the implanted device to be received and sensed outside the body as suggested by Duggan.
Regarding claim 11, the combination of Knipfer and Duggan discloses forming the mold layer includes forming a mold layer that includes a ridge around the molded cavity (from paragraph 0036, see Similarly, the second portion 230 includes substantially parallel opposing inner 232 and outer 231 surfaces and is configured to enclose the cavity 227 defined by the first portion 220 when the housing 200 is assembled. In one embodiment, the second portion 230 includes one or more sidewalls 250b extending from the top 235. In one embodiment, the sidewalls 250b of the second portion 230 generally mirror the shape of the first portion 220 sidewalls 250a such that the one or more second portion 230 sidewalls 250b are configured to mate with the first portion 220 sidewalls 250a when the housing 200 is assembled. The sidewalls 250b of the second portion 230 terminate in a peripheral edge 266 disposed between the inner 232 and outer 231 surfaces of the sidewall 250b. In one embodiment, the second portion 230 sidewalls 250b have a height that is less than the height of the first 220 portion sidewalls 250a. In another embodiment, the second portion 230 sidewalls 250b have a height that is greater than the height of the first 220 portion sidewalls 250a. As used in the context of the first portion 220 sidewall 250a, the term "height" refers to the shortest linear distance between the top (or plane defined by the top) surface 225 of the housing 200 to the peripheral edge 265 of the sidewall 250a. Similarly, as used in the context of the second portion 230 sidewall 250b, the term "height" refers to the shortest linear distance between the base (or plane defined by the base) surface 235 of the housing 200 to the peripheral edge 266 of the sidewall 250b. In another embodiment, the second portion 230 sidewalls 250b have a height that is substantially the same as the first portion 220 sidewalls 250a. In an alternate embodiment (not shown), the second portion 230 does not include a sidewall, but rather includes a protrusion extending from the interior surface 232 of the top 235 that is spaced from the edge of the second portion 230 and follows the perimeter of the second portion 230. In this embodiment, the first portion 220 sidewall 250a is configured to physically overlap and rest externally to the protrusion such that the peripheral edge 265 of the first portion 220 engages the interior surface 232 of the top 235 when the housing 200 is assembled); and wherein the arranging the piezo speaker includes arranging the piezo speaker to contact the ridge of the mold layer and a metal wall of the metal case (from abstract of Duggan, see A piezoelectric element positioned adjacent the inside wall of the implantable device is selectively energized by an oscillator circuit operating from an energy storage capacitor).
Claim 12 is rejected for the same reasons as claim 4.
Claim 15 is rejected for the same reasons as claim 7.
Regarding claim 16, the combination of Knipfer and Duggan discloses arranging, between the metal case and the molded cavity, a piezo speaker that includes a circular piezoelectric ceramic contacting a brass disk (from column 5 of Duggan, see Referring now to FIGS. 3 and 4, the transducer used in the preferred embodiment of the invention, and its mounting in a pacemaker housing are shown. The preferred transducer as shown in FIG. 3 is a ceramic piezoelectric element. It comprises a generally circular brass disc or plate 40, on top of which is bonded a ceramic piezoelectric element indicated by reference number 41. Brass disc 40 serves as one electrode for the transducer, and a metalized layer is formed on top of piezoelectric element 41 to serve as the other electrode. In FIG. 3, the metalized layer electrode is indicated by reference number 42. A zone of layer 42 is cut away to provide separation for a separate tab or finger portion indicated by reference number 43. This tab is also made of the metalized electrode layer in contact with the underlying ceramic piezoelectric element, but it is electrically separate from electrode portion 42, so as to provide a feedback electrode. Electrical connections are made via brass disc 40, and an electrical conductor 44 which is soldered to electrode 42, and conductor 45 which is soldered to electrode 43), and covering the brass disk and the piezoelectric ceramic with a layer of polymide (from column 5 of Duggan, see Transducer 22 is mounted to the inside of lower wall 52. Specifically, brass disc 40 may be secured to wall 52 by a suitable adhesive, or by welding. Adhesive bonding can be accomplished by coating the entire surface of the disc with Eastman 910 adhesive, for example. A plastic insulating layer 57 is sandwiched between the top of transducer 22 and inner partition 53 for purposes of electrical insulation. In case a separate inner partition 53 is not used, plastic layer 57 would insulate the transducer from the battery case itself).
Regarding claim 17, Knipfer discloses an apparatus comprising:
a hermetically sealed metal case having a metal wall (from paragraph 0030, see FIG. 1 is a schematic view of an implantable medical device 100 shown in conjunction with a heart 50. The device 100 generally includes a hermetically sealed housing 200 that encases the electronics for the device 100);
a mold layer arranged within the metal case, the mold layer including a molded cavity (from paragraph 0073, see As used herein, the term "molding" refers to a process of manufacturing in which a pliable raw material is shaped using a pattern or mold having a desired size and shape. Typically, the mold defines a cavity that is configured to receive a flowable material such as a liquefied or molten metal or metal alloy. After the flowable material is introduced into the mold, it is allowed to harden and adopt the shape of the mold. After the material hardens, the final product is removed from the mold. Many molding processes are known and include, but are not limited to: injection molding, compression molding, transfer molding, extrusion molding, rotational molding, and the like. Briefly, in an injection molding process, the flowable material is forced into a mold cavity where it cools and hardens to the configuration of the mold cavity. In a compression molding process, the molding material is generally placed in an open mold cavity which is then closed with a top force or plug member and pressure is applied to force the material into contact with all mold areas. In a transfer molding process, the molding material is preheated and loaded into a chamber. A plunger is then used to force the material from the chamber through channels known as a sprue and runner system into the mold cavities. The mold remains closed as the material is added and is opened to release the molded component) and a ridge around the perimeter of the molded cavity (from paragraph 0036, see Similarly, the second portion 230 includes substantially parallel opposing inner 232 and outer 231 surfaces and is configured to enclose the cavity 227 defined by the first portion 220 when the housing 200 is assembled. In one embodiment, the second portion 230 includes one or more sidewalls 250b extending from the top 235. In one embodiment, the sidewalls 250b of the second portion 230 generally mirror the shape of the first portion 220 sidewalls 250a such that the one or more second portion 230 sidewalls 250b are configured to mate with the first portion 220 sidewalls 250a when the housing 200 is assembled. The sidewalls 250b of the second portion 230 terminate in a peripheral edge 266 disposed between the inner 232 and outer 231 surfaces of the sidewall 250b. In one embodiment, the second portion 230 sidewalls 250b have a height that is less than the height of the first 220 portion sidewalls 250a. In another embodiment, the second portion 230 sidewalls 250b have a height that is greater than the height of the first 220 portion sidewalls 250a. As used in the context of the first portion 220 sidewall 250a, the term "height" refers to the shortest linear distance between the top (or plane defined by the top) surface 225 of the housing 200 to the peripheral edge 265 of the sidewall 250a. Similarly, as used in the context of the second portion 230 sidewall 250b, the term "height" refers to the shortest linear distance between the base (or plane defined by the base) surface 235 of the housing 200 to the peripheral edge 266 of the sidewall 250b. In another embodiment, the second portion 230 sidewalls 250b have a height that is substantially the same as the first portion 220 sidewalls 250a. In an alternate embodiment (not shown), the second portion 230 does not include a sidewall, but rather includes a protrusion extending from the interior surface 232 of the top 235 that is spaced from the edge of the second portion 230 and follows the perimeter of the second portion 230. In this embodiment, the first portion 220 sidewall 250a is configured to physically overlap and rest externally to the protrusion such that the peripheral edge 265 of the first portion 220 engages the interior surface 232 of the top 235 when the housing 200 is assembled); and
a component, wherein the ridge of the mold layer biases the component against the metal wall, and the component is arranged within the molded cavity (from paragraph 0003, see Implantable medical devices (IMDs) are commonly used to provide treatment to patients. Implantable medical devices can include cardiac rhythm management (CRM) devices, including pacemakers and Implantable Cardioverter Defibrillators (ICDs). In general, CRM devices deliver electrical stimuli to a target tissue via a lead wire having one or more electrodes disposed in or about the target tissue. The lead wire is typically connected to a pulse generator contained within a housing. In addition to the pulse generator, the housing can also contain other system components. Typically, the housing is formed by stamping the desired shaped components from a sheet of metal).
Still on the issue of claim 17, Knipfer does not teach the component is a piezo speaker. All the same, Duggan discloses the component is a piezo speaker (from abstract, see A piezoelectric element positioned adjacent the inside wall of the implantable device is selectively energized by an oscillator circuit operating from an energy storage capacitor). Therefore, it would have been obvious to one of ordinary skill in the art to modify Knipfer wherein the component is a piezo speaker as taught by Duggan. This modification would have improved the system’s efficiency by providing a means for transmitting data from within the implanted device to be received and sensed outside the body as suggested by Duggan.
Regarding claim 19, the combination of Knipfer and Duggan discloses a first insulating layer; and wherein the piezo circuit element includes the piezoelectric ceramic attached to a metal disk (from column 5 of Duggan, see The preferred transducer as shown in FIG. 3 is a ceramic piezoelectric element. It comprises a generally circular brass disc or plate 40, on top of which is bonded a ceramic piezoelectric element indicated by reference number 41. Brass disc 40 serves as one electrode for the transducer, and a metalized layer is formed on top of piezoelectric element 41 to serve as the other electrode. In FIG. 3, the metalized layer electrode is indicated by reference number 42. A zone of layer 42 is cut away to provide separation for a separate tab or finger portion indicated by reference number 43. This tab is also made of the metalized electrode layer in contact with the underlying ceramic piezoelectric element, but it is electrically separate from electrode portion 42, so as to provide a feedback electrode. Electrical connections are made via brass disc 40, and an electrical conductor 44 which is soldered to electrode 42, and conductor 45 which is soldered to electrode 43), and the insulating layer (from column 5 of Duggan, see A plastic insulating layer 57 is sandwiched between the top of transducer 22 and inner partition 53 for purposes of electrical insulation) is arranged between the metal disk of the piezo circuit element and the metal wall.
3. Claims 2 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Knipfer combined with Duggan in further view of O’Phelan et al, U.S. Patent No. 5,876,424 (hereinafter O’Phelan).
Regarding claim 2, the combination of Knipfer and Duggan discloses the molded cavity (from paragraph 0073 of Knipfer, see As used herein, the term "molding" refers to a process of manufacturing in which a pliable raw material is shaped using a pattern or mold having a desired size and shape. Typically, the mold defines a cavity that is configured to receive a flowable material such as a liquefied or molten metal or metal alloy. After the flowable material is introduced into the mold, it is allowed to harden and adopt the shape of the mold. After the material hardens, the final product is removed from the mold. Many molding processes are known and include, but are not limited to: injection molding, compression molding, transfer molding, extrusion molding, rotational molding, and the like. Briefly, in an injection molding process, the flowable material is forced into a mold cavity where it cools and hardens to the configuration of the mold cavity. In a compression molding process, the molding material is generally placed in an open mold cavity which is then closed with a top force or plug member and pressure is applied to force the material into contact with all mold areas. In a transfer molding process, the molding material is preheated and loaded into a chamber. A plunger is then used to force the material from the chamber through channels known as a sprue and runner system into the mold cavities. The mold remains closed as the material is added and is opened to release the molded component. In an extrusion molding process, the material is heated and then loaded into a die or container. A ram then presses the material to push it out of the die. In a rotational molding process the mold is slowly rotated (usually around two perpendicular axes) causing the material to flow into to the mold and adhere to the walls of the mold) of the mold layer includes a cavity surface opposite the piezo speaker (from abstract of Duggan, see A piezoelectric element positioned adjacent the inside wall of the implantable device is selectively energized by an oscillator circuit operating from an energy storage capacitor). Still on the issue of claim 2, the combination of Knipfer and Duggan does not clearly teach that the cavity surface is concave. All the same, O’Phelan discloses that the cavity surface is concave (from column 4, see End 68 includes a concave surface 80 contoured to correspond to the exterior shape). Therefore, it would have been obvious to one of ordinary skill in the art to further modify the combination of Knipfer and Duggan wherein the cavity surface is concave as taught by O’Phelan. This modification would have improved the system’s reliability by providing better protection as suggested by O’Phelan.
Regarding claim 10, although the combination of Knipfer and Duggan discloses forming the mold layer includes forming a mold layer (from paragraph 0073 of Knipfer, see As used herein, the term "molding" refers to a process of manufacturing in which a pliable raw material is shaped using a pattern or mold having a desired size and shape. Typically, the mold defines a cavity that is configured to receive a flowable material such as a liquefied or molten metal or metal alloy. After the flowable material is introduced into the mold, it is allowed to harden and adopt the shape of the mold. After the material hardens, the final product is removed from the mold. Many molding processes are known and include, but are not limited to: injection molding, compression molding, transfer molding, extrusion molding, rotational molding, and the like. Briefly, in an injection molding process, the flowable material is forced into a mold cavity where it cools and hardens to the configuration of the mold cavity) that includes a molded cavity having a cavity surface; and wherein arranging the piezo speaker includes arranging the piezo speaker opposite the cavity surface and in contact with a metal wall of the metal case (from abstract of Duggan, see A piezoelectric element positioned adjacent the inside wall of the implantable device is selectively energized by an oscillator circuit operating from an energy storage capacitor), the combination of Knipfer and Duggan does not clearly teach that the cavity surface is concave. All the same, O’Phelan discloses that the cavity surface is concave (from column 4, see End 68 includes a concave surface 80 contoured to correspond to the exterior shape). Therefore, it would have been obvious to one of ordinary skill in the art to further modify the combination of Knipfer and Duggan wherein the cavity surface is concave as taught by O’Phelan. This modification would have improved the system’s reliability by providing better protection as suggested by O’Phelan.
4. Claims 6 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Knipfer combined with Duggan in further view of Stahmann et al, U.S. Patent Application Publication No. 2019/0184179 (hereinafter Stahmann).
Regarding claim 6, although Knipfer discloses the mold layer includes a ridge around the molded cavity (from paragraph 0036 of Knipfer, see Similarly, the second portion 230 includes substantially parallel opposing inner 232 and outer 231 surfaces and is configured to enclose the cavity 227 defined by the first portion 220 when the housing 200 is assembled. In one embodiment, the second portion 230 includes one or more sidewalls 250b extending from the top 235. In one embodiment, the sidewalls 250b of the second portion 230 generally mirror the shape of the first portion 220 sidewalls 250a such that the one or more second portion 230 sidewalls 250b are configured to mate with the first portion 220 sidewalls 250a when the housing 200 is assembled. The sidewalls 250b of the second portion 230 terminate in a peripheral edge 266 disposed between the inner 232 and outer 231 surfaces of the sidewall 250b. In one embodiment, the second portion 230 sidewalls 250b have a height that is less than the height of the first 220 portion sidewalls 250a. In another embodiment, the second portion 230 sidewalls 250b have a height that is greater than the height of the first 220 portion sidewalls 250a. As used in the context of the first portion 220 sidewall 250a, the term "height" refers to the shortest linear distance between the top (or plane defined by the top) surface 225 of the housing 200 to the peripheral edge 265 of the sidewall 250a. Similarly, as used in the context of the second portion 230 sidewall 250b, the term "height" refers to the shortest linear distance between the base (or plane defined by the base) surface 235 of the housing 200 to the peripheral edge 266 of the sidewall 250b. In another embodiment, the second portion 230 sidewalls 250b have a height that is substantially the same as the first portion 220 sidewalls 250a. In an alternate embodiment (not shown), the second portion 230 does not include a sidewall, but rather includes a protrusion extending from the interior surface 232 of the top 235 that is spaced from the edge of the second portion 230 and follows the perimeter of the second portion 230. In this embodiment, the first portion 220 sidewall 250a is configured to physically overlap and rest externally to the protrusion such that the peripheral edge 265 of the first portion 220 engages the interior surface 232 of the top 235 when the housing 200 is assembled), the combination of Knipfer and Duggan does not clearly teach the molded cavity includes a gas sealed by the ridge around the molded cavity. All the same, Stahmann discloses the cavity includes a gas sealed around the cavity (from paragraph 0043, see Additionally, commonly used housings may be non-conformal requiring control of gases inside the housing including, for example, controlling gaseous water and/or hydrogen). Therefore, it would have been obvious to one of ordinary skill in the art to further modify the combination of Knipfer and Duggan wherein the cavity includes a gas sealed around the cavity as taught by Stahmann. This modification would have improved the system’s flexibility by providing a drug infusion pump as suggested by Stahmann.
Claim 14 is rejected for the same reason as claim 6.
5. Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Knipfer combined with Duggan and O’Phelan in further view of Stahmann.
Regarding claim 18, although the combination of Knipfer and Duggan discloses the molded cavity includes a surface (from paragraph 0004, see The first portion includes a base and one or more sidewalls, each with an interior surface and an exterior surface, wherein the interior surfaces of the base and sidewalls define a cavity), the combination of Knipfer and Duggan does not clearly teach that the cavity surface is concave. All the same, O’Phelan discloses that the cavity surface is concave (from column 4, see End 68 includes a concave surface 80 contoured to correspond to the exterior shape). Therefore, it would have been obvious to one of ordinary skill in the art to further modify the combination of Knipfer and Duggan wherein the cavity surface is concave as taught by O’Phelan. This modification would have improved the system’s reliability by providing better protection as suggested by O’Phelan.
Still on the issue of claim 18, the combination of base references does not clearly teach gas sealed in the molded cavity. All the same, Stahmann discloses sealed gas (from paragraph 0043, see Additionally, commonly used housings may be non-conformal requiring control of gases inside the housing including, for example, controlling gaseous water and/or hydrogen). Therefore, it would have been obvious to one of ordinary skill in the art to further modify the combination of references with sealed gas as taught by Stahmann. This modification would have improved the system’s flexibility by providing a drug infusion pump as suggested by Stahmann.
6. Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Knipfer combined with Duggan in further view of Bobgan et al, U.S. Patent Application Publication No. 2016/0287880 (hereinafter Bobgan).
Regarding claim 20, the combination of Knipfer and Duggan does not clearly teach a second insulating layer arranged between the piezo circuit element and the mold layer. All the same, Barry discloses a second insulating layer arranged between the circuit element and the layer (from paragraph 0058, see a single layer flex circuit 350 includes a single conductive layer 352 sandwiched between two dielectric, insulating layers 354, 356). Therefore, it would have been obvious to one of ordinary skill in the art to further modify the combination of Knipfer and Duggan with a second insulating layer arranged between the circuit element and the layer as taught by Barry. This modification would have improved the system’s reliability by providing better shielding as suggested by Bobgan.
Allowable Subject Matter
7. Claims 5 and 13 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
8. Any inquiry concerning this communication or earlier communications from the examiner should be directed to OLISA ANWAH whose telephone number is 571-272-7533. The examiner can normally be reached Monday to Friday from 8.30 AM to 6 PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Carolyn Edwards can be reached on 571-270-7136. The fax phone numbers for the organization where this application or proceeding is assigned are 571-273-8300 for regular communications and 571-273-8300 for After Final communications.
Any inquiry of a general nature or relating to the status of this application or proceeding should be directed to the receptionist whose telephone number is 571-272-2600.
Olisa Anwah
Patent Examiner
January 9, 2026
/OLISA ANWAH/Primary Examiner, Art Unit 2692
/CAROLYN R EDWARDS/Supervisory Patent Examiner, Art Unit 2692