DETAILED ACTION
Response to Arguments
Applicant’s arguments, see page 12, filed 2/6/2026, with respect to the rejections of claims 2-8 under Orinski in view of Buddha and Shanahan have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground of rejection is made in view of Sochor.
Applicant’s arguments, see pages 12-13, filed 2/6/2026, with respect to the rejections of claims 9-11 under Orinski in view of Buddha and Hirata have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground of rejection is made in view of Loo.
In response to applicant's argument that Hirata is nonanalogous art, it has been held that a prior art reference must either be in the field of the inventor’s endeavor or, if not, then be reasonably pertinent to the particular problem with which the inventor was concerned, in order to be relied upon as a basis for rejection of the claimed invention. See In re Oetiker, 977 F.2d 1443, 24 USPQ2d 1443 (Fed. Cir. 1992). In this case, the examiner agrees with the applicant’s argument, and the rejection is withdrawn.
Applicant’s arguments, see page 14, filed 2/6/2026, with respect to the rejection of claim 20 under Orinski in view of Buddha and Leigh has been fully considered and is persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground of rejection is made in view of Reed.
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 2 and 5 are rejected under 35 U.S.C. 103 as being unpatentable over Orinski (U.S. Patent No. 10,576,292) in view of Sochor (U.S. Patent No. 7,736,191) and Buddha et al. (WIPO Pub. No. 2021/003439).
Regarding claim 2, Orinski teaches a device (Fig. 1, Col. 1, lines 34-35),
comprising: at least one lead (Fig. 1, Col. 1, lines 40-41), each of the at least one lead including a plurality of electrodes (Fig. 1, Col. 1, line 39); a housing (Fig. 4A, Col. 3, lines 3-5) including a lead retention feature (Col. 3, line 5); stimulator circuitry (Col. 4, line 45); and a battery (Fig. 5, Col. 4, line 41) configured to provide electrical power (Col. 5, lines 40-41) to the stimulator circuitry, wherein the stimulator circuitry and the battery are within the housing (Col. 4, lines 44-46), each of the at least one lead including a plurality of electrical conductors (Col. 5, lines 57-58) extending from the proximal lead end (Fig. 1, Col. 3, line 52) to provide electrical connections (Col. 5, line 9) to the plurality of electrodes, the plurality of electrical conductors being electrically connected to the stimulator circuitry (Col. 6, lines 1-6), the proximal lead end being retained within the housing by the lead retention feature (Col. 3, lines 52-55).
Orinski does not teach that the lead retention feature includes, for each of the at
least one lead, at least one clip configured to receive and grip a proximal lead end to retain the proximal lead end within the housing, each of the least one clip includes housing features separated by a gap corresponding to a diameter of the proximal lead end, and the proximate lead end is received by the gap and clipped between the features.
Sochor, however, teaches an implantable connector that has a lead retention
feature (Fig. 1A-1B, Col. 6, line 37) that includes at least one clip (Fig. 2, Col. 7, line 18) configured to receive and grip (Fig. 3-4) a proximal lead end (Fig. 1A-B, Col. 7, lines 1-2) to retain the proximal lead end within the housing (Fig. 2). Sochor also teaches that the at least one clip includes housing features (Fig. 5, Col. 8, line 20) separated by a gap corresponding to a diameter of the proximal lead end (Fig. 3-4), and the proximate lead end is received by the gap and clipped between the features (Fig. 3-4).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Orinski to incorporate the teachings of Sochor to include that the lead retention feature includes at least one clip configured to receive and grip a proximal lead end to retain the proximal lead end within the housing, where each clip includes housing features separated by a gap corresponding to a diameter of the proximal lead end, and the proximate lead end is received by the gap and clipped between the features. Doing so would ensure that the proximal lead ends don’t get disconnected from the housing or move around inside, as recognized by Sochor.
Orinski also does not teach that the stimulator circuitry includes a waveform
generator configured to generate an electrical waveform and a controller configured to electrically drive the electrical waveform through at least one of the plurality of electrodes. Buddha, however, teaches an implantable device that comprises a controller (Paragraph 0082, line 6), which further includes a stimulation waveform generator (Paragraph 0082, lines 6-7). Buddha also teaches that the controller delivers stimulation energy (Paragraph 0097, line 1) in the form of a stimulation waveform (Paragraph 0097, lines 21-22).
It would have been obvious to one of ordinary skill in the art before the effective
filing date of the claimed invention to have modified Orinski to incorporate the teachings of Buddha to use stimulator circuitry that includes a waveform generator and controller, where the controller is configured to electrically drive the electrical waveform. Doing so would allow for manipulation of voltages and electrical energy that is being delivered to the plurality of electrodes, as recognized by Buddha
Regarding claim 5, Orinski teaches the device (Fig. 1, Col. 1, lines 34-35) of claim 2, further comprising a coil (Fig. 5, Col. 4, lines 36-37) electrically connected to the stimulator circuitry (Col. 3, line 37), the housing (Fig. 4A, Col. 3, lines 3-5) including a coil frame (Fig. 5, Col. 4, lines 37-38) configured to hold the coil, wherein the coil frame includes the lead retention feature (Col. 3, line 5).
Orinski does not teach that the lead retention feature includes the at least one clip
for each of the at least one lead. Sochor, however, teaches an implantable connector that has a lead retention feature (Fig. 1A-1B, Col. 6, line 37) that includes at least one clip (Fig. 2, Col. 7, line 18) for each of the at least one lead (Fig. 1-2).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Orinski to incorporate the teachings of Sochor to include that the lead retention feature includes the at least one clip for each of the at least one lead. Doing so would ensure that the proximal lead ends don’t get disconnected from the housing or move around inside, as recognized by Sochor.
Claims 3-4 and 6-8 are rejected under 35 U.S.C. 103 as being unpatentable over Orinski (U.S. Patent No. 10,576,292) in view of Sochor (U.S. Patent No. 7,736,191) and Buddha et al. (WIPO Pub. No. 2021/003439) as applied to claim 2 above, and further in view of Shanahan et al. (U.S. PGPub No. 2016/0158558).
Regarding claim 3, Orinski teaches the device (Fig. 1, Col. 1, lines 34-35) of
claim 2. Orinski does not teach that the at least one clip for each of the at least one lead includes at least two clips to provide a non-linear lead path for gripping the proximal lead end to retain the proximal lead end within the housing.
Sochor, however, teaches an implantable connector that has a lead retention
feature (Fig. 1A-1B, Col. 6, line 37) that includes at least one clip (Fig. 2, Col. 7, line 18)
configured to receive and grip (Fig. 3-4) a proximal lead end (Fig. 1A-B, Col. 7, lines 1-2) to retain the proximal lead end within the housing (Fig. 2). Sochor also teaches that the at least one clip includes at least two clips (Fig. 2). Shanahan, however, teaches an electrical stimulation system with a lead retention feature (Fig. 4B, Paragraph 0059, lines 1-4) that includes a non-linear lead path (Fig. 4A-B) for gripping the proximal lead end to retain it in the housing.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Orinski to incorporate the teachings of Sochor and Shanahan to include that the at least one clip for each of the at least one lead includes at least two clips to provide a non-linear lead path for gripping the proximal lead end to retain it within the housing. Doing so would ensure that the proximal lead ends don’t get disconnected from the housing or move around inside, as recognized by Sochor and Shanahan.
Regarding claim 4, Orinski teaches the device (Fig. 1, Col. 1, lines 34-35) of claim 3. Orinski does not teach wherein the at least one clip for each of the at least one lead includes at least three clips, and the non-linear lead path includes a winding path. Sochor, however, teaches that the at least one clip (Fig. 2, Col. 7, line 18) includes at least three clips (Fig. 2). Shanahan, however, teaches an electrical stimulation system with a lead retention feature (Fig. 4B, Paragraph 0059, lines 1-4) that includes a non-linear lead path that includes a winding path (Fig. 4A-B).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Orinski to incorporate the teachings of Sochor and Shanahan to include that the at least one clip for each of the at least one lead includes at least three clips, and the non-linear lead path includes a winding path. Doing so would ensure that the proximal lead ends don’t get disconnected from the housing or move around inside, as recognized by Sochor and Shanahan.
Regarding claim 6, Orinski teaches the device (Fig. 1, Col. 1, lines 34-35) of claim 5, wherein the coil frame (Fig. 5, Col. 4, lines 37-38) includes a periphery (Fig. 11, Col. 9, lines 41-43) configured to receive the coil (Fig. 5, Col. 4, lines 36-37). Orinski does not teach a raised central region corresponding to a center of the coil, wherein at least some of the at least three clips are in the raised central region.
Sochor, however, teaches that the at least one clip (Fig. 2, Col. 7, line 18) includes at least three clips (Fig. 2). Shanahan, however, teaches an electrical stimulation system with a lead retention feature (Fig. 4B, Paragraph 0059, lines 1-4) located in a raised central region (Fig. 4A-4C).
It would have been obvious to one of ordinary skill in the art before the effective
filing date of the claimed invention to have modified Orinski to incorporate the teachings
of Sochor and Shanahan to provide a raised central region including at least some of the at least three clips in the center of the coil as part of the overall coil frame. Doing so would ensure that coil frame encompasses both the interior and exterior peripheries of the coil so as to further limit movement of the coil, as recognized by Sochor and Shanahan.
Regarding claim 7, Orinski teaches the device (Fig. 1, Col. 1, lines 34-35) of claim 5. Orinski does not teach wherein the at least one clip includes raised features separated by a distance corresponding to a diameter of the proximal lead end to receive the proximal lead end between the raised features.
Sochor, however, teaches an implantable connector that has a lead retention feature (Fig. 1A-1B, Col. 6, line 37) that includes at least one clip (Fig. 2, Col. 7, line 18) for each of the at least one lead (Fig. 1-2). Furthermore, Sochor teaches that the at least one clip includes raised features (Fig. 5, Col. 8, lines 16-20) separated by a distance corresponding to a diameter of the proximal lead end (Fig. 3-4) to receive the proximal lead end between the raised features (Fig. 3-4).
It would have been obvious to one of ordinary skill in the art before the effective
filing date of the claimed invention to have modified Orinski to incorporate the teachings of Sochor to include at least one clip that includes raised features separated by a distance corresponding to the diameter of the proximal lead. Doing so would ensure that the proximal lead ends fit tightly within the clip mechanism so that they are secure and do not move around within the housing, as recognized by Sochor.
Regarding claim 8, Orinski teaches the device (Fig. 1, Col. 1, lines 34-35) of claim 7. Orinski does not teach that the proximal lead end includes an insulator coating that is compressed when the proximal lead end is inserted between the raised features. Sochor, however, teaches an implantable connector that includes at least one clip (Fig. 2, Col. 7, line 18) that includes raised features (Fig. 5, Col. 8, lines 16-20) to receive the proximal lead end between the raised features (Fig. 3-4). Shanahan, however, teaches a proximal lead end that includes an insulator coating (Paragraph 0043, lines 9-12) that is compressed (Paragraph 0059, lines 11-13) when the proximal lead end is in between the raised features (Fig. 4A-4C, Paragraph 0059, lines 13-15).
It would have been obvious to one of ordinary skill in the art before the effective
filing date of the claimed invention to have modified Orinski to incorporate the teachings
of Sochor and Shanahan to have a proximal lead end that includes an insulator coating and is compressed when in between raised features of the clip mechanism. Doing so would improve electrical conduction for the proximal lead end and ensure a tight fit within the clip so that the lead end is secure, as recognized by Sochor and Shanahan.
Claims 9-11 and 16-19 are rejected under 35 U.S.C. 103 as being unpatentable over Orinski (U.S. Patent No. 10,576,292) in view of Buddha et al. (WIPO Pub. No. 2021/003439) and Loo et al. (U.S. Patent No. 12,309,954).
Regarding claim 9, Orinski teaches a device (Fig. 1, Col. 1, lines 34-35),
comprising: a housing (Fig. 4A, Col. 3, lines 3-5) including a lead retention feature (Col. 3, line 5); at least one lead (Fig. 1, Col. 1, lines 40-41), each of the at least one lead including a plurality of electrodes (Fig. 1, Col. 1, line 39); stimulator circuitry (Col. 4, line 45); and a battery (Fig. 5, Col. 4, line 41) configured to provide electrical power (Col. 5, lines 40-41) to the stimulator circuitry; wherein the stimulator circuitry and the battery are within the housing (Col. 4, lines 44-46), each of the at least one lead including a plurality of electrical conductors (Col. 5, lines 57-58) extending from a proximal lead end (Fig. 1, Col. 3, line 52) to provide electrical connections (Col. 5, line 9) to the plurality of electrodes, the plurality of electrical conductors being electrically connected to the stimulator circuitry (Col. 6, lines 1-6), and the proximal lead end being retained within the housing by the lead retention feature (Col. 3, lines 52-55).
Orinski does not teach that the stimulator circuitry includes a waveform generator
configured to generate an electrical waveform and a controller configured to electrically drive the electrical waveform through at least one of the plurality of electrodes. However, Buddha teaches an implantable device that comprises a controller (Paragraph 0082, line 6), which further includes a stimulation waveform generator (Paragraph 0082, lines 6-7). Buddha also teaches that the controller delivers stimulation energy (Paragraph 0097, line 1) in the form of a stimulation waveform (Paragraph 0097, lines 21-22).
It would have been obvious to one of ordinary skill in the art before the effective
filing date of the claimed invention to have modified Orinski to incorporate the teachings of Buddha to use stimulator circuitry that includes a waveform generator and controller, where the controller is configured to electrically drive the electrical waveform. Doing so would allow for manipulation of voltages and electrical energy that is being delivered to the plurality of electrodes, as recognized by Buddha.
Orinski also does not teach that the device further includes a battery liner adjacent to at least a portion of a periphery of the battery, the battery liner including at least one spring configured to press against the periphery of the battery to resist battery movement in the device.
Loo, however, teaches a protective housing for implantable medical devices that includes a battery (Col. 11, lines 32-36 and Col. 18, line 8) and a battery liner (Col. 19, line 60) adjacent to at least a portion of a periphery of the battery (Fig. 4C-4D). Loo also teaches that the battery liner includes at least one spring (Fig. 4C, 4G, Col. 19, lines 57-58) configured to press against the periphery of the battery (Fig. 4C-4D, Col. 19, lines 59-60) to resist battery movement in the device (Fig. 4G, Col. 19, lines 60-63).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Orinski to incorporate the teachings of Loo to include a battery liner adjacent to at least a portion of a periphery of the battery, where the battery liner includes at least one spring configured to press against the periphery of the battery to resist battery movement in the device. Doing so would ensure that the battery does not move around within the housing once the device is implanted, which would further improve device functionality and longevity, as recognized by Loo.
Regarding claim 10, Orinski teaches the device (Fig. 1, Col. 1, lines 34-35) of claim 9. Orinski does not teach a battery liner that is configured to be positioned along at least a width edge of the battery and a length edge of the battery, wherein the at least one spring includes one or more springs along the width edge of the battery to constrain battery movement in a length direction and one or more springs along the length edge of the battery to constrain the battery movement in a width direction.
Loo, however, teaches a protective housing for implantable medical devices that includes a battery (Col. 11, lines 32-36 and Col. 18, line 8) and a battery liner (Col. 19, line 60) adjacent to at least a portion of a periphery of the battery (Fig. 4C-4D). Loo teaches that the battery liner is configured to be positioned along at least a width edge (Fig. 4C-4D) of the battery and a length edge (Fig. 4C-4D) of the battery.
Loo also teaches that the battery liner includes at least one spring (Fig. 4C, 4G, Col. 19, lines 57-58) along the depth edge configured to resist battery movement in a depth direction (Fig. 4G, Col. 19, lines 60-63). However, Loo discloses that the springs could be mounted to the curved portions (422) or angled faces of the battery liner as well (Fig. 4G, Col. 19, lines 60-63). It would therefore be understood that placing the springs along the flat or curved portions would be along either the width edge of the battery to constrain battery movement in a length direction, and along the length edge of the battery to constrain the battery movement in a width direction.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Orinski to incorporate the teachings of Loo to include a battery liner around the periphery of the battery along both the length and width edges, and to include one or more springs on both the width and length sides of the battery to restrict movement in both directions. Doing so would ensure that the battery does not move around within the housing in either direction, which would further improve device functionality and longevity, as recognized by Loo.
Regarding claim 11, Orinski teaches the device (Fig. 1, Col. 1, lines 34-35) of claim 9. Orinski does not teach that the at least one spring includes an arch spring. Loo, however, teaches a protective housing for implantable medical devices that includes at least one spring (Fig. 4C, 4G, Col. 19, lines 57-58) that is an arch spring (Fig. 4G, Col. 19, line 58).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Orinski to incorporate the teachings of Loo to include that the at least one spring includes an arch spring. Doing so would ensure that the battery does not move around within the housing once the device is implanted, which would further improve device functionality and longevity, as recognized by Loo.
Regarding claim 16, Orinski in view of Buddha and Loo discloses the claimed invention of claim 9. Orinski further discloses a device (Fig. 1, Col. 1, lines 34-35) of claim 9, wherein the device includes a bottom surface corresponding to a contour of a skull (Fig. 3A-3B, Col. 8, lines 41-43).
Regarding claim 17, Orinski in view of Buddha and Loo discloses the claimed invention of claim 16. Orinski further discloses a device (Fig. 1, Col. 1, lines 34-35) of claim 16, wherein the housing (Fig. 4A, Col. 3, lines 3-5) of the device includes; a base mold (Fig. 5, Col. 4, lines 18-21) having a first portion with a first planar bottom surface (Fig. 3B, Col. 3, lines 14-16) and a second portion with a second planar bottom surface (Fig. 3B, Col. 3, lines 14-16), the first and second planar bottom surfaces forming an angle corresponding to a skull contour (Fig. 3A-3B, Col. 8, lines 41-43); a coil frame (Fig. 5, Col. 4, lines 37-38) for holding a coil (Fig. 5, Col. 4, lines 36-37) on the first portion of the base mold (Fig. 5); and a can assembly (Fig. 4A, Col. 3, lines 22-23) for housing the stimulator circuitry (Col. 3, line 37) on the second portion of the base mold.
Regarding claim 18, Orinski in view of Buddha and Loo discloses the claimed invention of claim 17. Orinski further discloses a device (Fig. 1, Col. 1, lines 34-35) of claim 17, wherein the coil frame (Fig. 5, Col. 4, lines 37-38) has an interface (Fig. 4C, 5, 6C-6D) with the can assembly (Fig. 4A, Col. 3, lines 22-23), each of the coil frame near the interface and the can assembly near the interface having features for enhancing an ability of epoxy (Col. 6, lines 59-61) to fix the coil frame to the can assembly, wherein the epoxy is provided over the interface and hardens (Col. 7, lines 49-52) to fix the coil frame to the can assembly.
Regarding claim 19, Orinski in view of Buddha and Loo discloses the claimed invention of claim 18. Orinski further discloses a device (Fig. 1, Col. 1, lines 34-35) of claim 18, wherein the features for enhancing the ability of the epoxy (Col. 6, lines 59-61) to fix the coil frame (Fig. 5, Col. 4, lines 37-38) to the can assembly (Fig. 4A, Col. 3, lines 22-23) includes apertures (Fig. 7B, Col. 6, lines 58-59) in each of the coil frame and the can assembly, and wherein the epoxy at least partially fills the apertures.
Claims 12-15 are rejected under 35 U.S.C. 103 as being unpatentable over Orinski (U.S. Patent No. 10,576,292) in view of Buddha et al. (WIPO Pub. No. 2021/003439) and Loo et al. (U.S. Patent No. 12,309,954) as applied to claim 9 above, and further in view of Shanahan et al. (U.S. PGPub No. 2016/0158558).
Regarding claim 12, Orinski teaches a device (Fig. 1, Col. 1, lines 34-35) of claim 9, further comprising a strain relief at a housing-lead interface where the at least one lead (Fig. 1, Col. 1, lines 40-41) enters the housing (Fig. 4A, Col. 3, lines 3-5). Orinski does not teach a strain relief element at a housing-lead interface. However, Shanahan teaches a strain relief element for a lead that is entering a housing (Fig. 5A-5C, paragraph 0061, lines 7-8).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Orinski to incorporate the teachings of Shanahan to have a strain relief element located at a lead-housing interface. Doing so would create less strain on the proximal lead end as it enters the housing, which would in turn prevent the proximal lead end from becoming disconnected, as recognized by Shanahan.
Regarding claim 13, Orinski teaches a device (Fig. 1, Col. 1, lines 34-35) of claim 12, wherein the strain relief includes side webs (Fig. 4A) on each side of the at least one lead (Fig. 1, Col. 1, lines 40-41), each of the side webs extending from a first position (Fig. 4A) that is near the housing (Fig. 4A, 4C) and away from the leads to a second position (Fig. 4A) that is near the leads and away from the housing (Fig. 4A, 4C).
Orinski does not teach a strain relief element that includes side webs on each side
of the at least one lead. However, Shanahan teaches a strain relief element for a lead that
is entering a housing (Fig. 5A-5C, paragraph 0061, lines 7-8).
It would have been obvious to one of ordinary skill in the art before the effective
filing date of the claimed invention to have modified Orinski to incorporate the teachings
of Shanahan to have a strain relief element include the side web elements that are taught
in Orinski. Doing so would create less strain on the proximal lead end as it enters the
housing, which would in turn prevent the proximal lead end from becoming
disconnected, as recognized by Shanahan.
Regarding claim 14, Orinski teaches a device (Fig. 1, Col. 1, lines 34-35) of claim 13, further comprising a suture hole formed in at least one of the side webs (Fig. 4A). Orinski also teaches screw holes that can be used to attach the device to the patient's skull (Fig. 3B, Col. 3, lines 28-33). Orinski does not teach suture holes being used to attach the device to a patient's skull. Buddha, however, teaches suture holes (Paragraph 0161, lines 1-10) that are used to attach the implantable device to tissue within the patient's body.
It would have been obvious to one of ordinary skill in the art before the effective
filing date of the claimed invention to have modified Orinski to incorporate the teachings
of Buddha to allow the screw holes that are used to attach the device to a patient's skull
to also be used as suture holes. Doing so would provide healthcare providers with a less
invasive way to attach said implantable device to a patient's skull, as recognized by
Buddha.
Regarding claim 15, Orinski teaches a device (Fig. 1, Col. 1, lines 34-35) of claim 13, further comprising a suture hole formed in each of the side webs (Fig. 4A). Orinski also teaches screw holes that can be used to attach the device to the patient's skull (Fig. 3B, Col. 3, lines 28-33). Orinski does not teach suture holes being used to attach the device to a patient's skull. Buddha, however, teaches suture holes (Paragraph 0161, lines 1-10) that are used to attach the implantable device to tissue within the patient's body.
It would have been obvious to one of ordinary skill in the art before the effective
filing date of the claimed invention to have modified Orinski to incorporate the teachings
of Buddha to allow the screw holes that are used to attach the device to a patient's skull
to also be used as suture holes. Doing so would provide healthcare providers with a less
invasive way to attach said implantable device to a patient's skull, as recognized by
Buddha.
Claims 20-21 are rejected under 35 U.S.C. 103 as being unpatentable over Orinski (U.S. Patent No. 10,576,292) in view of Buddha et al. (WIPO Pub. No. 2021/003439) and Reed et al. (WIPO Pub. No. 2019/104187).
Regarding claim 20, Orinski teaches a device (Fig. 1, Col. 1, lines 34-35),
comprising: a housing (Fig. 4A, Col. 3, lines 3-5) including a lead retention feature (Col. 3, line 5); at least one lead (Fig. 1, Col. 1, lines 40-41), each of the at least one lead including a plurality of electrodes (Fig. 1, Col. 1, line 39); stimulator circuitry (Col. 4, line 45); a battery (Fig. 5, Col. 4, line 41) configured to provide electrical power (Col. 5, lines 40-41) to the stimulator circuitry; wherein the stimulator circuitry and the battery are within the housing (Col. 4, lines 44-46), each of the at least one lead including a plurality of electrical conductors (Col. 5, lines 57-58) extending from a proximal lead end (Fig. 1, Col. 3, line 52) to provide electrical connections (Col. 5, line 9) to the plurality of electrodes, the plurality of electrical conductors being electrically connected to the stimulator circuitry (Col. 6, lines 1-6), the proximal lead end being retained within the housing by the lead retention feature (Col. 3, lines 52-55), wherein the housing of the device includes; a base mold (Fig. 5, Col. 4, lines 18-21) having a first portion with a first planar bottom surface (Fig. 3B, Col. 3, lines 14-16) and a second portion with a second planar bottom surface (Fig. 3B, Col. 3, lines 14-16), the first and second planar bottom surfaces forming an angle corresponding to a skull contour (Fig. 3A-3B, Col. 8, lines 41-43) such that the bottom surfaces for both the first and second portions are approximately tangent to a skull surface (Fig. 3B); a coil frame (Fig. 5, Col. 4, lines 37-38) for holding a coil (Fig. 5, Col. 4, lines 36-37) on the first portion of the base mold (Fig. 5); and a can assembly (Fig. 4A, Col. 3, lines 22-23) for housing the stimulator circuitry on the second portion of the base mold.
Orinski does not teach that the stimulator circuitry includes a waveform generator
configured to generate an electrical waveform and a controller configured to electrically drive the electrical waveform through at least one of the plurality of electrodes. However, Buddha teaches an implantable device that comprises a controller (Paragraph 0082, line 6), which further includes a stimulation waveform generator (Paragraph 0082, lines 6-7). Buddha also teaches that the controller delivers stimulation energy (Paragraph 0097, line 1) in the form of a stimulation waveform (Paragraph 0097, lines 21-22).
It would have been obvious to one of ordinary skill in the art before the effective
filing date of the claimed invention to have modified Orinski to incorporate the teachings of Buddha to use stimulator circuitry that includes a waveform generator and controller, where the controller is configured to electrically drive the electrical waveform. Doing so would allow for manipulation of voltages and electrical energy that is being delivered to the plurality of electrodes, as recognized by Buddha
Orinski also does not teach that the device further includes a flexible tail, the
flexible tail and the coil frame being on opposing sides of the can assembly, the base mold having a third portion with a third planar bottom portion, the flexible tail being formed on the third portion, the third portion having a bottom surface forming an angle corresponding to the skull contour.
Reed, however, teaches a low-profile head-located neurostimulator that includes a flexible tail (Fig. 71A-B, Paragraph 0275, lines 1-3), a coil frame (Fig. 71A-B), and a can assembly (Fig. 71A-B, Paragraph 0274, line 2). Furthermore, Reed teaches that the flexible tail and the coil frame are on opposite sides of the can assembly (Fig. 71A-B). Reed also teaches the neurostimulator has a base mold (Fig. 71A-B, Paragraph 0275, line 1), wherein the base mold has a third portion with a third planar bottom portion (Fig. 71A-B). Reed teaches that the flexible tail is formed on the third portion (Fig. 71A-B), and that the third portion has a bottom surface forming an angle corresponding to the skull contour (Fig. 71A-B, Paragraph 0254, lines 1-5).
It would have been obvious to one of ordinary skill in the art before the effective
filing date of the claimed invention to modify Orinski to incorporate the teachings of Reed to include that the device further includes a flexible tail, the flexible tail and the coil frame being on opposing sides of the can assembly, the base mold having a third portion with a third planar bottom portion, the flexible tail being formed on the third portion, and the third portion having a bottom surface forming an angle corresponding to the skull contour. Doing so would ensure that the implantable device better fits to the contour of each patient’s skull, as recognized by Reed.
Regarding claim 21, Orinski teaches the device (Fig. 1, Col. 1, lines 34-35) of claim 20, wherein: the coil frame (Fig. 5, Col. 4, lines 37-38) has an interface (Fig. 4C, 5, 6C-D) with the can assembly (Fig. 4A, Col. 3, lines 22-23), each of the coil frame near the interface and the can assembly near the interface having features for enhancing an ability of epoxy (Col. 6, lines 59-61) to fix the coil frame to the can assembly, the epoxy is provided over the interface and hardens (Col. 7, lines 49-52) to fix the coil frame to the can assembly, the features for enhancing the ability of the epoxy to fix the coil frame to the can assembly includes apertures (Fig. 7B, Col. 6, lines 58-59) in each of the coil frame and the can assembly, and the epoxy at least partially fills the apertures.
Conclusion
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.
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/H.A.H./Patent Examiner, Art Unit 3796
/CARL H LAYNO/Supervisory Patent Examiner, Art Unit 3796