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 .
Response to Amendment
The amendment filed 09 December 2025 has been entered. Claims 1, 4, 6, 8-9, 16-17, 10, and 21-22 are currently amended. Claims 2, 3, 5, 7, 10-14, 18, and 23 are canceled, and claims 24-31 are new. Claims 1, 4, 6, 8-9, 15-17, 19-22, and 24-31 are pending in the application.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1, 4, 8, 19-20, 24, 26, 29, and 31 are rejected under 35 U.S.C. 103 as being unpatentable over Schulman et al. (US Patent No. 5,358,514), hereinafter Schulman, in view of Hovland et al. (US PGPub No. 2016/0129264), hereinafter Hovland, and Hassler et al. (US Patent No. 5,470,345), hereinafter Hassler, and further in view of Perraud et al. (US PGPub No. 2016/0015987), hereinafter Perraud.
Regarding claim 1, Schulman teaches an implantable nerve transducer (col 1, lines 12-15: “microminiature stimulator (or "microstimulator") or microminiature sensor (or "microsensor") adapted to securely attach to one or more muscle or nerve fibers”) comprising:
a fully non-metallic biocompatible glass housing defining a chamber (Fig. 3: glass housing 22 and glass bead 26 defining a chamber);
a stimulator circuit positioned within the chamber (Fig. 3: IC chip 28; electrodes 14 and 15 within housing 22);
the chamber being hermetically sealed (col 4, lines 14-15: “a hermetically-sealed housing that is inert to body fluids and tissue”);
the implantable nerve transducer being configured to be implantable and configured to stimulate a nerve, block a neural signal, or sense nerve signals of a living organism (col 2, lines 44-51: “an implantable microdevice, e.g., a microstimulator or microsensor, is housed within a small, sealed, housing. Such housing includes all the requisite electronic circuitry for sensing a specified parameter or generating electrical stimulation pulses that can be applied to a selected nerve or muscle, as well as circuitry for inductively receiving power and control signals from an external source”).
Schulman does not teach a battery or a hermetic second chamber for housing such a battery. However, in an analogous art, Hovland teaches an implantable stimulator with a battery (par. 0002: “In order to provide the implantable medical device with autonomy from any external power source, an internal battery may be included to provide the electrical power”) and a hermetic second chamber for housing the battery separate from the stimulation circuitry (Fig. 2: medical device 102 with stimulation circuitry 202 and separate battery enclosure 112; par. 0024: “The medical device 102 is attached to a separate battery enclosure 112 that contains a battery that has a housing that is insulated from exterior conditions”), which provides modularity for different types of batteries (par. 0005: “providing a separate enclosure for the battery that may be attached to the enclosure of the medical device to provide modularity. Thus, the separate enclosure may be constructed as necessary to accommodate the desired battery while the medical device may remain the same”). Hovland further teaches wherein the first and second chambers are separated by a rigid separator plate with a first aperture passing through the rigid separator plate and configured to electrically connect the hermetic solid-state battery to the stimulator circuit (Fig. 7: adapter plate 406, opening 407; par. 0034: “The adapter plate 406 also includes one or more openings 407 that allow the terminal pins 412 to extend beyond the outer enclosure 404 and therefore exits the separate enclosure configuration 402 in order to extend into the housing 210 of the medical device 202”).
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 device of Schulman by including a battery housed in a separate hermetic chamber with a rigid separator plate having an aperture for electrical connection, as taught by Hovland, in order to provide the implantable device with autonomy from any external power source, as well as modularity for different types of batteries, as taught by Hovland.
The combined reference does not explicitly teach wherein the rigid separator plate is made of glass. However, in an analogous art, Hassler teaches using a fully dielectric material for a feedthrough substrate providing electrical connection through a hermetic seal (Fig. 4: ceramic feedthrough area 408 with vias 410). In light of Hassler’s teaching, and because Schulman teaches glass and ceramic as obvious alternatives of one another for use in the housing of an implantable device (col 12, lines 58-61: “Alternatively, the housing may be a ceramic, cast or molded epoxy or silicon rubber, or other material which is hermetically-sealable, inert and suitable for implantation”), it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to select glass as the material for the rigid separator plate, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416. See also Ballas Liquidating Co. v. Allied industries of Kansas, Inc. (DC Kans) 205 USPQ 331.
The combined reference further does not explicitly teach wherein the battery is a stack of glass wafer-based solid-state battery cells, each of the battery cells comprising a solid electrolyte disposed between an anode and a cathode, all formed in or on a glass wafer-based substrate. However, in an analogous art, Perraud teaches a solid-state battery for use in implantable devices that comprises a stack of glass wafer-based solid-state battery cells (par. 0051: “Each secondary battery consists of a substrate onto which a thin-film stack has been deposited or transferred. The various secondary batteries may be stacked on top of each other […] This allows the voltage or the capacity of the energy storing subsystem to be increased”),
each of the battery cells comprising a solid electrolyte disposed between an anode and a cathode, all formed in or on a glass wafer-based substrate (Fig. 5: thin film stack 53 and substrate 52; par. 0051: “The substrate 52 is for example a silicon wafer, a glass wafer […] The thin-film stack 53 comprises current collector materials (metals), materials for forming cathodes (TiOxSy, LiCoO2, LiMn2O4, LiFePO4, V2O5, etc.), materials for forming electrolytes (solid electrolytes such as Lipon, which is a material based on lithium, phosphorus, oxygen and nitrogen), and materials for forming anodes (Li, or an alloy of Li with C, Si, Ge and/or Sn)”).
Perraud teaches that solid electrolyte batteries can withstand large numbers of charge/discharge cycles (par. 0003) and that the disclosed thin-film solid-state batteries allows for implantable devices to be ultra-thin (par. 0021-0022: “Advantageously, such an implantable power source may have over the entirety of its area, or over at least 80% of the latter if it also comprises subsystems that are difficult to produce in thin-film technologies, a thickness smaller than or equal to 1 mm (and therefore “ultra-thin”). Another subject of the invention is an implantable device comprising an implantable power source as claimed in one of the preceding claims and a medical apparatus connected to said energy storing subsystem in order to be powered. Advantageously, said medical device may in turn be ultra-thin”). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to use Perraud’s stack of thin-film solid-state battery cells in the implantable device of the combined reference, so that the battery can withstand several thousand recharging cycles with a larger voltage or capacity of energy storage while allowing the device to be ultra-thin, as taught by Perraud. Examiner further interprets a solid-state battery sealed in a hermetic chamber, as disclosed by the combined reference, to read on the limitation of a hermetic solid-state battery, as broadly as claimed.
Regarding claim 4, the combination teaches the device of claim 1 as described previously. Schulman further teaches wherein the stimulator circuit comprises a controller and a coil configured to wirelessly receive electromagnetic energy (Fig. 3: IC chip 28 and coil 11; col 4, lines 37-41: “information and power are received by the coil, inside the body, from an alternating magnetic field modulated in accordance with information, where the alternating magnetic field is generated from a source and location outside the body”), but does not explicitly teach wherein the coil is configured to provide electrical power to the hermetic solid-state battery to recharge the hermetic solid-state battery. However, Perraud further teaches a coil configured to provide electrical power to the hermetic solid-state battery to recharge the hermetic solid-state battery (par. 0013: “at least one energy harvesting subsystem connected to said energy storing subsystem so as to allow the latter to be charged” and par. 0049: “The energy harvesting subsystem of the rechargeable implantable power source may comprise a thin-film spiral coil […] In this case, the rechargeable implantable power source may be recharged by transcutaneous transfer of energy by inductive coupling”), which provides longer battery life without need for a surgical operation (par. 0003: “the secondary battery can be recharged by transcutaneous energy transfer, without the need for a surgical operation. This type of implantable power source has the advantage of possessing a longer lifetime than primary batteries”). 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 device of the combined reference by configuring the coil to recharge the battery, as taught by Perraud, to provide longer battery life without need for a surgical operation, as taught by Perraud.
Regarding claim 8, the combination teaches the device of claim 1 as described previously. Hovland teaches providing electrical passthrough pins configured for connection with a lead (Figs. 1-2: lead 106, header block 104, feedthrough conductors 206), but does not explicitly teach further comprising a second aperture passing through the rigid separator plate at an exposed external portion of the second opposite side of the rigid separator plate and configured to align with a lead connector of the stimulator circuit, the second housing covering a portion of the opposite second side, the remaining portion being the exposed external portion. However, to simply rearrange the disclosed parts in the device of the combined reference and provide the lead connection portion on the same side of the electronic compartment as the battery (rather than the opposite side of the electronic compartment as disclosed) would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, since it has been held that rearranging parts of an invention involves only routine skill in the art. In re Japikse, 86 USPQ 70.
Regarding claim 19, the method limitations are rejected for the same reasons set forth previously in the rejection of claim 1, because the method as claimed merely recites the formation of an implantable nerve transducer as recited in claim 1.
Regarding claim 20, the combination teaches the method of claim 19 as described previously. Schulman further teaches implanting the implantable nerve transducer within the living organism; and powering the implantable nerve transducer to stimulate the nerve, block a nerve signal of the nerve, or sense nerve signals from the nerve of the living organism (col 6, lines 53-62: “The present invention relates to a microdevice that uses a self-attaching electrode to anchor or otherwise secure the microdevice in a desired implant location, e.g., to a desired nerve bundle or muscle tissue. The microdevice may comprise an electronic stimulating device that derives operating power from an externally applied alternating magnetic field; with the microdevice being controlled by control information that modulates such magnetic field”).
Regarding claims 24 and 29, the combination teaches the device of claim 1 and method of claim 19 as described previously. The combination does not explicitly teach wherein the stimulator circuit is mounted directly upon a glass wafer-based substrate attached to or formed as the rigid glass separator plate. However, Hassler further teaches wherein electronics can be mounted directly to a wall of an implantable device enclosure, which saves time, money, and parts (col 3, lines 11-15: “The multi-layered nature of the wall 402 of the ceramic enclosure half 206 allows the hybrid circuitry 406 of the pacemaker to be mounted directly on the ceramic enclosure, thereby saving time, money and parts compared with prior art ceramic enclosures”). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to mount the stimulator circuit directly to the rigid glass separator plate (that is, one of the walls of the enclosure), as taught by Hassler, in order to save time, money, and parts, as taught by Hassler.
Regarding claims 26 and 31, the combination teaches the device of claim 1 and the method of claim 19 as described previously. Hassler further teaches wherein the first aperture is filled with conductive material forming a bi-directional conductive contact to which both the stimulator circuit and the hermetic solid-state battery are coupled (Fig. 4: feedthroughs 410; col 3, lines 18-27: “a feedthrough area 408. The several layers of the ceramic material have metal-plated input/output vias used to electrically connect the various layers. […] The feedthroughs 410 electrically connect the circuitry carried by the enclosure to the connector block 208;” wherein plated and filled vias both provide feedthrough electrical connection on opposite sides of a substrate such that they are functional equivalents). Hassler also teaches that the disclosed feedthrough substrate is less expensive to produce (col 1, lines 50-52: “an implantable medical device wherein its feedthrough substrate is less expensive than prior art feedthrough substrates”). 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 device of the combined reference by providing vias for electrical connection through the separator plate, as suggested by Hassler, so that the substrate may be less expensive to produce, as taught by Hassler.
Claims 6, 9, and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Schulman in view of Hovland, Hassler, and Perraud, and further in view of Faltys et al. (US Patent No. 6,308,101), hereinafter Faltys ‘101.
Regarding claims 6 and 9, Schulman in view of Hovland, Hassler, and Perraud teaches the device of claim 1 as described previously. Schulman further teaches wherein the coil can directly power the device without a battery (col 4, lines 37-39: “information and power are received by the coil, inside the body, from an alternating magnetic field”), but the combination does not explicitly teach wherein the coil is configured to provide electrical power to the controller when the solid-state battery is discharged, or wherein the stimulator circuit comprises a bypass circuit, which together with the controller and coil is configured to wirelessly receive electromagnetic energy and provide electrical power directly to the controller bypassing the solid-state battery using the bypass circuit.
However, in related art, Faltys ‘101 teaches an battery-powered implantable medical device with a coil configured to provide electrical power to a controller when the battery is discharged (Fig. 8: coil 220 receiving electromagnetic energy from external device 232; col 19, lines 22-25: “should ISP unit malfunction, or should its battery go dead, or for other reasons, the patient can still use the ICS unit as long as it is coupled in conventional manner (through coil 220) with an external controller;” col 2, lines 30-39: “the rechargeable device may be continuously powered from a small, lightweight external unit, if necessary or desirable. Thus, in the event the internal (implanted) battery within the device malfunctions, or for whatever reason cannot be used, or the user or clinician (or other medical personnel) does not want to use it, it is still possible, through use of the lightweight external device, to provide operating power to the implantable device so that it may continue to provide its intended function (e.g., stimulating and/or sensing);” examiner notes that a bypass circuit that bypasses the battery is implicit with the disclosed configuration). Faltys ‘101 teaches that the disclosed configuration advantageously allows the patient to indefinitely delay battery replacement or corrective surgery (col 2, lines 39-41: “Advantageously, by having such a backup option available, the patient may delay indefinitely battery-replacement and/or corrective surgery”).
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 transducer of the combined reference by configuring the coil to provide electrical power to the controller when the battery is discharged, as taught by Faltys ‘101, in order to allow the patient to indefinitely delay battery replacement or corrective surgery in the event of a battery dying or malfunctioning, as taught by Faltys ‘101.
Regarding claim 21, Schulman in view of Hovland, Hassler, and Perraud teaches the method of claim 20 as described previously. Perraud further teaches charging the hermetic solid-state battery using electromagnetic energy wirelessly received by a coil, wherein powering the implantable nerve transducer comprises powering the implantable nerve transducer using the solid-state battery when the solid-state battery is not fully discharged (par. 0049: “The energy harvesting subsystem of the rechargeable implantable power source may comprise a thin-film spiral coil […] In this case, the rechargeable implantable power source may be recharged by transcutaneous transfer of energy by inductive coupling”). The combined reference does not explicitly teach powering the implantable nerve transducer using the coil when the solid-state battery is fully discharged, but the combination in view of Faltys ‘101 teaches this limitation for the same reasons set forth in the rejection of claims 6 and 9.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Schulman in view of Hovland, Hassler, and Perraud, and further in view of Brockway et al. (US PGPub No. 2009/0192381), hereinafter Brockway.
Schulman in view of Hovland, Hassler, and Perraud teaches the device of claim 1 as described previously. The combination does not explicitly teach further comprising a wireless antenna placed in the second chamber and configured to avoid electrical interference with the stimulator circuit in the first chamber. However, in an analogous art, Brockway teaches an implantable device with two chambers, comprising a wireless antenna placed in a second chamber apart from an electrical circuit in the first chamber and configured to avoid electrical interference with the circuit in the first chamber (Fig. 23 and par. 0092: “In this implementation, the battery 1030 and electronics module 1035 are grouped within the first rigid section 1015a, and the charging coil 1040 and the telemetry antenna 1045 are grouped within the second rigid section 1015b;” examiner interprets the separation of the wireless antenna and circuit as configured to avoid electrical interference), which can be used to communicate with an external device (par. 0074: “A telemetry module 935 may be used, in conjunction with the telemetry antenna, for communication with an external device”). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to provide the transducer of Scott with the wireless antenna taught by Brockway in order to communicate with an external device, as taught by Brockway.
Claims 16-17 and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Schulman in view of Perraud and further in view of Berrang et al. (US PGPub No. 2003/0109903), hereinafter Berrang.
Regarding claim 16, as laid out previously in the rejection of claim 1, Schulman teaches an implantable nerve transducer comprising:
a fully non-metallic biocompatible glass housing defining a single hermetically sealed chamber;
and a stimulator circuit positioned within the glass housing;
the implantable nerve transducer being configured to be implantable and configured to stimulate a nerve, block a neural signal, or sense nerve signals of a living organism.
Schulman in view of Perraud further teaches a solid-state, wafer-based battery comprising a plurality of stacked cells, each of the cells comprising a glass substrate layer formed from a wafer and a solid electrolyte layer disposed between an anode and a cathode, the battery comprising no intervening enclosures between a top cell of the plurality of stacked cells and the glass housing (this limitation is regarded to be met since Schulman only teaches one enclosure), for the same reasons laid out previously in the rejection of claim 1.
Perraud further teaches a non-metallic biocompatible wafer-based substrate upon which a bottom cell of the plurality of stacked cells is directly mounted (par. 0051: “The substrate 52 is for example a silicon wafer, a glass wafer”).
The combined reference does not explicitly teach wherein the stimulator circuit is directly attached to a first side of the substrate, and the solid-state battery is disposed on an opposite second side of the substrate. However, in a related implantable medical device art, Berrang teaches a single-chambered housing (Fig. 22: housing 2,3 defining a single chamber) with a battery disposed on an opposite second side of a substrate from a first side upon which electronics are positioned (Fig. 22: low profile electronics 17 on first side of substrate, with low profile battery 67 on opposite side of substrate). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to arrange the battery and stimulator circuit of Schulman and Perraud on opposite sides of a substrate, as taught by Berrang, since it has been held that rearranging parts of an invention involves only routine skill in the art. In re Japikse, 86 USPQ 70.
Regarding claims 17 and 22, the combination teaches the device of claim 16 as described previously. Perraud further teaches wherein the wafer-based substrate comprises a ceramic material, or is a wafer-based glass substrate (par. 0051: “The substrate 52 is for example a silicon wafer, a glass wafer”).
Claims 25 and 30 are rejected under 35 U.S.C. 103 as being unpatentable over Schulman in view of Hovland, Hassler, and Perraud, and further in view of Gray et al. (US PGPub No. 2004/0263172), hereinafter Gray.
Schulman in view of Hovland, Hassler, and Perraud teaches the device of claim 24 and the method of claim 29 as described previously. Perraud further teaches wherein the hermetic solid-state battery comprises no free-lithium materials (par. 0051: “materials for forming electrolytes (solid electrolytes such as Lipon, which is a material based on lithium, phosphorus, oxygen and nitrogen)”), but the combination does not explicitly teach wherein the implantable nerve transducer is MRI compatible. However, in an analogous art, Gray teaches making an implantable medical device MRI compatible (par. 0024: “medical device or system that reduces or eliminates the undesirable effects of changing magnetic fields from an MRI system on the medical devices and/or patients undergoing medical procedures or that have temporary or permanent implanted materials and/or devices with conducting components”) to protect a patient, physician, and electronic components (par. 0003: “a device for protecting a patient, physician, and/or electronic components in an electrical device implanted or partially implanted within the patient. More particularly, the present invention is directed to a device for protecting the conductive parts of the electrical device from current and voltage surges induced by magnetic resonance imaging systems' oscillating magnetic fields”). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to make the implantable nerve transducer of the combined reference MRI compatible, as taught by Gray, in order to protect the patient, physician, or electronic components, as taught by Gray.
Claim 27 is rejected under 35 U.S.C. 103 as being unpatentable over Schulman in view of Perraud and Berrang and further in view of Hassler.
Schulman in view of Perraud and Berrang teaches the device of claim 16 as described previously. The combined reference in view of Hassler teaches further comprising a first aperture passing through the wafer-based substrate, the first aperture being filled with conductive material forming a bi-directional conductive contact to which both the stimulator circuit and the solid-state, wafer-based battery are coupled; for the same reasons set forth previously in the rejection of claims 26 and 31.
Claim 28 is rejected under 35 U.S.C. 103 as being unpatentable over Schulman in view of Perraud and Berrang and further in view of Gray.
Schulman in view of Perraud and Berrang teaches the device of claim 22 as described previously. The combination in view of Gray teaches the limitations of claim 28 for the same reasons set forth previously in the rejection of claims 25 and 30.
Response to Arguments
Applicant’s arguments, filed 09 December 2025, with respect to the rejection(s) of claim(s) 1, 16, and 19 under 35 U.S.C. 103 have been fully considered and are persuasive. Therefore, in light of the amendments to the claims, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Schulman, Hovland, Hassler, and Perraud. As described previously, Schulman teaches a glass housing for an implantable device, and Perraud teaches a stacked glass wafer-based solid-state battery.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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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/LINDA C DVORAK/Primary Examiner, Art Unit 3794
/D.E.L./Examiner, Art Unit 3794