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 .
This Non-Final Rejection is being sent in view of the Pre-Appeal Brief Conference decision to reopen prosecution.
Status of Claims
Claims 1-14 are rejected. Claim 15 is canceled. Claims 16-20 are withdrawn.
Claim Rejections - 35 USC § 103
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1, 3-5, 9, and 12-14 are rejected under 35 U.S.C. 103 as being unpatentable over Singhal (US 20070074732 filed on 9/25/06 as cited in the IDS) in view of Howard (US 20170214268 filed on 11/17/16).
Regarding claim 1, Singhal teaches an implantable medical device (¶61-implantale medical device 201; Fig. 2) comprising: a housing (Fig. 2-housing of 201; ¶61-each of modules 210-212 includes a respective housing) comprising a first major surface (Fig. 2-see top surface of 201; ¶61), a second major surface (Fig. 2-see bottom surface of 201; ¶61), a sidewall that extends between the first major surface and the second major surface (Fig. 2-see slanted and curved sidewall defining the perimeter of the housing of 201; ¶61), and a port disposed in the sidewall (Fig. 2-see cable 102 connects to 213 and extends through port in housing; ¶61-modular implantable medical device 201 also contains a set of lead connection modules 213 that permits external leads 102 (FIGS. 1C and 1D) to be connected to control module 210 as needed), wherein the sidewall defines a perimeter of the housing (Fig. 2-see slanted and curved sidewall defining the perimeter of the housing of 201; ¶61); an electronic component disposed within the housing (Fig. 2-see control module 210; ¶61- modular implantable medical device 201 includes three modules: a control module 210, a power source module 211, and a recharge module 212); and a cable electrically connected to the electronic component disposed within the housing, wherein the cable extends through the port (Fig. 2-see cable 102 connects to 213 to connect to control module 210 and extend through port; ¶61-modular implantable medical device 201 also contains a set of lead connection modules 213 that permits external leads 102 (FIGS. 1C and 1D) to be connected to control module 210 as needed).
However, Singhal does not explicitly teach a fastener configured to removably connect at least a portion of the cable to the housing adjacent an outer surface of the sidewall such that the portion of the cable extends along at least a portion of the perimeter of the housing when the portion of the cable is removably connected to the housing, and wherein the fastener is configured to be directly secured to the housing at one or more predetermined positions relative to the perimeter of the housing.
Howard relates to a wireless charger for an implantable medical device such as an implantable pulse generator (¶3). Howard further teaches the invention using the following steps:
a fastener configured to removably connect at least a portion of the cable to the housing adjacent an outer surface of the sidewall such that the portion of the cable extends along at least a portion of the perimeter of the housing (¶39-cable-holding mechanism 140 is shown in FIGS. 9A and 9B as comprising a material separate from the housings 104a and 104b, in other examples it could simply comprise the edges of the housings 104a and 104b as they are formed. Also, cable-holding mechanism 140 could comprise other well-known structures such as clips, clasps, Velcro™, etc; ¶42-these are just examples, and the housings 104a and 104b can be connectable and separable in other ways, such as by clips, grooves, Velcro™, etc.; Figs. 9A and 9B; MPEP 2114: "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987)); when the portion of the cable is removably connected to the housing (¶39-cable-holding mechanism 140 is shown in FIGS. 9A and 9B as comprising a material separate from the housings 104a and 104b, in other examples it could simply comprise the edges of the housings 104a and 104b as they are formed. Also, cable-holding mechanism 140 could comprise other well-known structures such as clips, clasps, Velcro™, etc; ¶42-these are just examples, and the housings 104a and 104b can be connectable and separable in other ways, such as by clips, grooves, Velcro™, etc.; ¶30-a cable connects these two housings. The two housings can be connected in a first physical configuration, and separated in a second physical configuration; Figs. 9A and 9B; MPEP 2114: "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987)), and wherein the fastener is configured to be directly secured to the housing at one or more predetermined positions relative to the perimeter of the housing (¶39-cable-holding mechanism 140 is shown in FIGS. 9A and 9B as comprising a material separate from the housings 104a and 104b, in other examples it could simply comprise the edges of the housings 104a and 104b as they are formed. Also, cable-holding mechanism 140 could comprise other well-known structures such as clips, clasps, Velcro™, etc; ¶42-these are just examples, and the housings 104a and 104b can be connectable and separable in other ways, such as by clips, grooves, Velcro™, etc.; Figs. 9A and 9B-show cable-holding mechanism 140 at one or more predetermined positions relative to the perimeter of the housing 104a and 104b; MPEP 2114: "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987)).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Singhal to include a fastener configured to removably connect at least a portion of the cable to the housing adjacent an outer surface of the sidewall such that the portion of the cable extends along at least a portion of the perimeter of the housing when the portion of the cable is removably connected to the housing, and wherein the fastener is configured to be directly secured to the housing at one or more predetermined positions relative to the perimeter of the housing of Howard in order to retain the cable against the edges of either or both of the electronics housing and coil housing (Howard, ¶38) to prevent extra slack of the cable (Howard, ¶38).
Regarding claim 3, the combination of Singhal and Howard teaches the device of claim 1, wherein the fastener comprises a slot disposed adjacent the sidewall of the housing, wherein the slot is adapted to retain the portion of the cable that is removably connected to the housing (Howard, Fig. 9A-cable-holding mechanism 140 is adjacent the sidewall of the housing; ¶39-cable-holding mechanism 140 could also comprise a recess formed into either or both of the housings 104 a and 104 b into which the cable 108 can be stuffed when the housings are connected; ¶38-FIG. 9A shows an example in which cable-holding mechanism 140 comprises a deformable rubberized material including a groove 142 ( FIG. 9B) into which the cable 108 can be press fit when the electronics housing 104 b and the coil housing 104 a are connected ( FIG. 4A), and from which the cable 108 can be “peeled” when the two housings are separated ( FIG. 5); Fig. 9B).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Singhal to include wherein the fastener comprises a slot disposed adjacent the sidewall of the housing, wherein the slot is adapted to retain the portion of the cable that is removably connected to the housing of Howard in order for the cable to press fit when the electronics housing and coil housing are connected, and from which the cable can be peeled when the two housings are separated (Howard, ¶38). In addition, the slot retains the cable against the edges of either or both of the electronics housing and coil housing to prevent extra slack of the cable (Howard, ¶38).
Regarding claim 4, the combination of Singhal and Howard teaches the device of claim 3, further comprising a resilient gasket that is disposed over the sidewall of the housing (Howard, ¶38-cable-holding mechanism 140 comprises a deformable rubberized material; Figs. 9A, 9B), wherein the slot is disposed in the resilient gasket (Howard, ¶38- cable-holding mechanism 140 comprises a deformable rubberized material including a groove 142 ( FIG. 9B) into which the cable 108 can be press fit when the electronics housing 104 b and the coil housing 104 a are connected ( FIG. 4A)).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Singhal to include a resilient gasket that is disposed over the sidewall of the housing, wherein the slot is disposed in the resilient gasket of Howard in order for the cable to press fit when the electronics housing and coil housing are connected, and from which the cable can be peeled when the two housings are separated (Howard, ¶38). In addition, the slot retains the cable against the edges of either or both of the electronics housing and coil housing to prevent extra slack of the cable (Howard, ¶38).
Regarding claim 5, the combination of Singhal and Howard teaches the device of claim 4, wherein the resilient gasket comprises an outer edge (Howard, ¶38-a cable-holding mechanism 140 to retain the cable 108 against the edges of either or both of the electronics housing 104 b and coil housing 104 a. FIG. 9A shows an example in which cable-holding mechanism 140 comprises a deformable rubberized material; Figs. 9A, 9B-show the cable-holding mechanism 140 comprising a deformable rubberized material including a groove 142 on an outer edge between 104a and 104b) that is adapted to deflect when engaging tissue of a patient to stabilize the device within the tissue (Singhal, ¶48-a lubricious material, as described herein, may be disposed on or impregnated in at least a portion of the implantable medical device 80. A lubricious material is any material that when applied to an implantable medical device reduces the friction between the implantable medical device and the adjacent tissue; MPEP 2114: "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987)).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Singhal to include wherein the resilient gasket comprises an outer edge of Howard in order for the cable to press fit when the electronics housing and coil housing are connected, and from which the cable can be peeled when the two housings are separated (Howard, ¶38).
Regarding claim 9, the combination of Singhal and Howard teaches the device of claim 1, further comprising a resilient substrate disposed on the second major surface of the housing (Singhal, ¶68-member 214 at least partially encapsulates modules 210-212. Further, as will be described in greater detail below, lead connection modules 213 may be formed in member 214. Member may integrate modules 210-212 into a structure. Member 214 may provide a flexible structure that permits the device 501 to conform to a variety of implant locations; ¶70-member 214 may comprise a solid biocompatible elastomeric material that is soft and flexible such as silicone. In some embodiments, member 214 comprises two or more materials, and two or more components. For example, member may comprise one or more elastomeric components formed of an elastomeric material, such as silicone, and one or more non-elastomeric components formed of a non-elastomeric material, such as polysulfone, or a polyurethane; ¶26; Fig. 2), wherein a portion of the resilient substrate is adapted to extend over the portion of the cable and be connected to the first major surface of the housing by the fastener (Howard, ¶38-a cable-holding mechanism 140 to retain the cable 108 against the edges of either or both of the electronics housing 104 b and coil housing 104 a, cable-holding mechanism 140 comprises a deformable rubberized material including a groove 142 ( FIG. 9B) into which the cable 108 can be press fit when the electronics housing 104 b and the coil housing 104 a are connected ( FIG. 4A), and from which the cable 108 can be “peeled” when the two housings are separated ( FIG. 5); Figs. 9A, 9B).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Singhal to include wherein a portion of the resilient substrate is adapted to extend over the portion of the cable and be connected to the first major surface of the housing by the fastener of Howard in order for the cable to press fit when the electronics housing and the coil housing are connected, and from which the cable can be peeled when the two housings are separated (Howard, ¶38).
Regarding claim 12, the combination of Singhal and Howard teaches the device of claim 9, wherein the fastener is connected to the housing and the resilient substrate (Howard, ¶38-a cable-holding mechanism 140 to retain the cable 108 against the edges of either or both of the electronics housing 104 b and coil housing 104 a, cable-holding mechanism 140 comprises a deformable rubberized material including a groove 142 ( FIG. 9B) into which the cable 108 can be press fit when the electronics housing 104 b and the coil housing 104 a are connected ( FIG. 4A), and from which the cable 108 can be “peeled” when the two housings are separated ( FIG. 5); Figs. 9A, 9B-cable-holding mechanism 140 is connected to housings 104a and 104b, as well as a deformable rubberized material including a groove 142).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Singhal to include wherein the fastener is connected to the housing and the resilient substrate of Howard in order for the cable to press fit when the electronics housing and the coil housing are connected, and from which the cable can be peeled when the two housings are separated (Howard, ¶38).
Regarding claim 13, the combination of Singhal and Howard teaches the device of claim 1, wherein the housing is encased within a resilient material (Singhal, ¶26-a member coupled to the module or modules for providing a smooth interface between the device and the scalp or the tissue near the scalp, the member can include elastomeric materials, such as silicone, and/or non-elastomeric materials such as polysulfone and polyurethane; Fig. 2-member 214; ¶70).
Regarding claim 14, Singhal teaches a wireless energy transfer system comprising an implantable medical device (¶62-power source module 211 includes a power source that provides energy to control module 210, which in some embodiments is a rechargeable power source such as a rechargeable battery and/or capacitor. Recharge module 212 includes a recharge coil for inductively receiving energy to recharge a rechargeable power source within power source module 211; ¶61-implantale medical device 201; Fig. 2), the system comprising: a housing (Fig. 2-housing of 201; ¶61-each of modules 210-212 includes a respective housing) comprising a first major surface (Fig. 2-see top surface of 201; ¶61), a second major surface (Fig. 2-see bottom surface of 201; ¶61), a sidewall that extends between the first major surface and the second major surface (Fig. 2-see slanted and curved sidewall defining the perimeter of the housing of 201; ¶61), and a port disposed in the sidewall (Fig. 2-see cable 102 connects to 213 and extends through port in housing; ¶61-modular implantable medical device 201 also contains a set of lead connection modules 213 that permits external leads 102 (FIGS. 1C and 1D) to be connected to control module 210 as needed), wherein the sidewall defines a perimeter of the housing (Fig. 2-see slanted and curved sidewall defining the perimeter of the housing of 201; ¶61); an electronic component disposed within the housing (Fig. 2-see control module 210; ¶61- modular implantable medical device 201 includes three modules: a control module 210, a power source module 211, and a recharge module 212); a coil disposed within the housing and electrically connected to the electronic component (Fig. 2-see recharge module 212; ¶62-recharge module 212 includes a recharge coil for inductively receiving energy to recharge a rechargeable power source within power source module 211); and a cable electrically connected to the electronic component disposed within the housing, wherein the cable extends through the port (Fig. 2-see cable 102 connects to 213 to connect to control module 210 and extend through port; ¶61-modular implantable medical device 201 also contains a set of lead connection modules 213 that permits external leads 102 (FIGS. 1C and 1D) to be connected to control module 210 as needed).
However, Singhal does not explicitly teach a fastener configured to removably connect at least a portion of the cable to the housing adjacent an outer surface of the sidewall such that the portion of the cable extends along at least a portion of the perimeter of the housing when the portion of the cable is removably connected to the housing, and wherein the fastener is configured to be directly secured to the housing at one or more predetermined positions relative to the perimeter of the housing.
Howard teaches a fastener configured to removably connect at least a portion of the cable to the housing adjacent an outer surface of the sidewall such that the portion of the cable extends along at least a portion of the perimeter of the housing (¶39-cable-holding mechanism 140 is shown in FIGS. 9A and 9B as comprising a material separate from the housings 104a and 104b, in other examples it could simply comprise the edges of the housings 104a and 104b as they are formed. Also, cable-holding mechanism 140 could comprise other well-known structures such as clips, clasps, Velcro™, etc; ¶42-these are just examples, and the housings 104a and 104b can be connectable and separable in other ways, such as by clips, grooves, Velcro™, etc.; Figs. 9A and 9B; MPEP 2114: "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987)) when the portion of the cable is removably connected to the housing (¶39-cable-holding mechanism 140 is shown in FIGS. 9A and 9B as comprising a material separate from the housings 104a and 104b, in other examples it could simply comprise the edges of the housings 104a and 104b as they are formed. Also, cable-holding mechanism 140 could comprise other well-known structures such as clips, clasps, Velcro™, etc; ¶42-these are just examples, and the housings 104a and 104b can be connectable and separable in other ways, such as by clips, grooves, Velcro™, etc.; ¶30-a cable connects these two housings. The two housings can be connected in a first physical configuration, and separated in a second physical configuration; Figs. 9A and 9B; MPEP 2114: "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987)), and wherein the fastener is configured to be directly secured to the housing at one or more predetermined positions relative to the perimeter of the housing (¶39-cable-holding mechanism 140 is shown in FIGS. 9A and 9B as comprising a material separate from the housings 104a and 104b, in other examples it could simply comprise the edges of the housings 104a and 104b as they are formed. Also, cable-holding mechanism 140 could comprise other well-known structures such as clips, clasps, Velcro™, etc; ¶42-these are just examples, and the housings 104a and 104b can be connectable and separable in other ways, such as by clips, grooves, Velcro™, etc.; Figs. 9A and 9B-show cable-holding mechanism 140 at one or more predetermined positions relative to the perimeter of the housing 104a and 104b; MPEP 2114: "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987)).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Singhal to include a fastener configured to removably connect at least a portion of the cable to the housing adjacent an outer surface of the sidewall such that the portion of the cable extends along at least a portion of the perimeter of the housing when the portion of the cable is removably connected to the housing, and wherein the fastener is configured to be directly secured to the housing at one or more predetermined positions relative to the perimeter of the housing of Howard in order to retain the cable against the edges of either or both of the electronics housing and coil housing (Howard, ¶38) to prevent extra slack of the cable (Howard, ¶38).
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Singhal in view of Howard as applied to claim 1 above, and further in view of Barolat (US 20080058876 filed on 9/6/06 as cited in the IDS).
Regarding claim 2, the combination of Singhal and Howard teaches the device of claim 1. However, the combination of Singhal and Howard does not explicitly teach wherein the fastener comprises a suture connected to the housing through an opening disposed in at least one of the first major surface or the second major surface of the housing adjacent the perimeter of the housing.
Barolat teaches wherein the fastener comprises a suture connected to the housing through an opening disposed in at least one of the first major surface or the second major surface of the housing adjacent the perimeter of the housing (¶10-an aperture adapted for receiving a suture; ¶41-referring now to FIGS. 9 and 10, and in accordance with embodiments of the present invention, a spool 204 is shown that includes an optional suture aperture 900 for suturing the spool 204 to surrounding tissue at a desired implantation site; Fig. 10-outer surface 222 has an opening 900 for suture 204 that is adjacent the perimeter of the housing).
Barolat relates to medical implants, and more particularly, to implants comprising a material that may be coiled (¶1).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Singhal to include wherein the fastener comprises a suture connected to the housing through an opening disposed in at least one of the first major surface or the second major surface of the housing adjacent the perimeter of the housing of Barolat in order to provide a way to secure the spool to a tissue of the patient (Barolat, ¶41).
Claims 6-7 are rejected under 35 U.S.C. 103 as being unpatentable over Singhal in view of Howard as applied to claims 1 and 5 above, and further in view of Fenster (US 5107836 filed on 10/3/90).
Regarding claim 6, the combination of Singhal and Howard teaches the device of claim 5. However, the combination of Singhal and Howard does not explicitly teach wherein the outer edge comprises first and second tabs disposed on each side of the slot, wherein the first and second tabs are adapted to rotate away from the slot when the outer edge of the gasket engages tissue of the patient.
Fenster teaches wherein the outer edge comprises first and second tabs disposed on each side of the slot (Figs. 3 and 5-36, 40, and 42; 40 and 42 are first and second tabs respectively on the outer edge of slot 36), wherein the first and second tabs are adapted to rotate away from the slot when the outer edge of the gasket engages tissue of the patient (col. 6, lines 56-58-the space 44 between the parts 40 and 42 which causes the parts to separate by a distance at least as great as a diameter of the electrical lead; MPEP 2114: "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987)).
Fenster relates to body implantable electrical signal generators and surgical procedures for implanting body implantable electrical signal generators (col. 1 and lines 7-10).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Singhal to include wherein the outer edge comprises first and second tabs disposed on each side of the slot, wherein the first and second tabs are adapted to rotate away from the slot when the outer edge of the gasket engages tissue of the patient of Fenster in order to causes the electrical lead to be retained within the channel (Fenster, col. 6 and lines 58-59) and eliminate the possibility of the coils of the redundant lead wire coming loose either during the surgical procedure or after the surgical procedure (Fenster, col. 6 and lines 63-65).
Regarding claim 7, the combination of Singhal and Howard teaches the device of claim 1. However, the combination of Singhal and Howard does not explicitly teach wherein the portion of the cable extends along at least 10% of the perimeter of the housing.
Fenster teaches wherein the portion of the cable extends along at least 10% of the perimeter of the housing (Fig. 4: 27, where the cable lead wire 27 wraps around and therefore extends around, 100% of the perimeter of housing 24).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Singhal to include wherein the portion of the cable extends along at least 10% of the perimeter of the housing of Fenster in order to force the excess electrical lead into the lead retainers so that only the electrical lead necessary to connect the signal generator to the part of the body is free to move after the incision is closed (Fenster, col. 5 and lines 37-41).
Claims 8 and 10-11 are rejected under 35 U.S.C. 103 as being unpatentable over Singhal in view of Howard as applied to claims 1 and 9 above, and further in view of Wilson (US 20130150940 filed on 11/20/12).
Regarding claim 8, the combination of Singhal and Howard teaches the device of claim 1. However, the combination of Singhal and Howard does not explicitly teach wherein the fastener comprises a resilient mesh, wherein the housing is disposed within the resilient mesh.
Wilson teaches wherein the fastener comprises a resilient mesh (Fig. 12-1202; ¶13-a reinforced compliant cuff body is provided that includes a compliant reinforcing mesh and a compliant coating attached to the reinforcing mesh), wherein the housing is disposed within the resilient mesh (¶91-the cuff body 102 may be a sheet or tube built from a natural or synthetic elastomeric polymer material including, but not limited to: silicone, urethane, nylon, rubber, polyester, polyethylene, or any other known elastomeric polymer material. The electrode assembly 100 may further incorporate a reinforcing textile or other reinforcing element (not shown) such as a polymer formed into a strand, sheet, or fabric).
Wilson relates to electrode assemblies for stimulating and/or recording electrical impulses in a biological structure such as a nerve, and more particularly to an improved reinforced compliant cuff body design that increases the safety and performance of implanted cuff assemblies. The invention offers enhancements for accessing biological structures such as peripheral nerves, cranial nerves, spinal roots, and the like and is of particular advantage for small diameter nerves, nerves that change diameter due to swelling or growth, and/or nerves that change shape, diameter, and position due to body movement (¶2).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Singhal to include wherein the fastener comprises a resilient mesh, wherein the housing is disposed within the resilient mesh of Wilson in order to form a reinforced protective cover over the entire outer surface of the device (Wilson, ¶118).
Regarding claim 10, the combination of Singhal and Howard teaches the device of claim 9. However, the combination of Singhal and Howard does not teach wherein the resilient substrate comprises a reinforcing layer disposed within a matrix.
Wilson teaches wherein the resilient substrate comprises a reinforcing layer disposed within a matrix (¶110-the one or more reinforcing members may be provided in the form of a mesh reinforcing element such as a deformable textile that defines a plurality of openings throughout the mesh; ¶111-the reinforcing textile may be incorporated directly into the cuff body matrix to form a composite material; ¶15; ¶100).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Singhal to include wherein the resilient substrate comprises a reinforcing layer disposed within a matrix of Wilson in order to form a reinforced protective cover over the entire outer surface of the device (Wilson, ¶118).
Regarding claim 11, the combination of Singhal, Howard, and Wilson teaches the device of claim 10, wherein the reinforcing layer comprises a mesh (Wilson, Fig. 12-1202; ¶13-a reinforced compliant cuff body is provided that includes a compliant reinforcing mesh and a compliant coating attached to the reinforcing mesh; ¶91-the cuff body 102 may be a sheet or tube built from a natural or synthetic elastomeric polymer material including, but not limited to: silicone, urethane, nylon, rubber, polyester, polyethylene, or any other known elastomeric polymer material. The electrode assembly 100 may further incorporate a reinforcing textile or other reinforcing element (not shown) such as a polymer formed into a strand, sheet, or fabric).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Singhal to include wherein the reinforcing layer comprises a mesh of Wilson in order to form a reinforced protective cover over the entire outer surface of the device (Wilson, ¶118).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 8209016: relates to implantable medical devices, more particularly devices employing medical leads and apparatuses for managing implanted leads (col. 1 and lines 13-15).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAURA HODGE whose telephone number is (571) 272-7101. The examiner can normally be reached M-F: 8:00 am-5:00 pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, UNSU JUNG can be reached at (571) 272-8506. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LAURA HODGE/Examiner, Art Unit 3792
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