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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on July 24, 2025 has been entered.
Information Disclosure Statement
The information disclosure statement(s) filed June 03, 2024, November 18, 2024, September 18, 2025, and July 24, 2026 has/have been considered by the Examiner.
Claim Interpretation
In accordance to MPEP 2111.04, such term(s) as “configured to” in the claim(s) do not limit claim scope to the particular function performed, and merely suggest optional functionality since the claim does not introduce any structure that positively recites and limits the features of the invention for exclusive use as intended. Absent limiting structural features, limitations following said clauses will be interpreted as recitations of intended use, wherein prior art will be evaluated based on its capability of performing and its suitability for the intended use. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. "[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). 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).
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.
Claim(s) 2-3, 11-19, 29, and 32 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pianca (US 20120041497 A1 – hereinafter Pianca) [PREVIOUSLY CITED] in view of Kallmyer (US 20130106347 A1 – hereinafter Kallmyer) [NEW].
Re. claim 2, Pianca teaches a method for treating a patient, comprising:
implanting an implantable device within the patient (paragraph 0024 – “The electrical stimulation system or components of the electrical stimulation system, including one or more of the lead bodies 106, the paddle body 104, and the control module 102, are typically implanted into the body of a patient”), wherein the implantable device comprises:
a housing (figure 1, housing 114);
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and further teaches a conduit integrated with and extending from the housing (figure 1, connector 144 sits above to integrate with the housing 114 and extends from the top of housing 114 to expose the connector 144),
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and a port positioned on a distal end of the conduit (similar embodiment figure 3A shows port 304 on a distal end of the connector 144), wherein the port comprises one or more first contacts (similar embodiment figure 3A shows the port 304 with contacts 314);
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and releasably coupling one or more second contacts on a lead to the one or more first contacts of the port to releasably couple the implantable device to the lead (paragraph 0023 – “The control module 102 typically includes a connector 144 (FIGS. 2 and 3A, see also 322 and 350 of FIG. 3B) into which the proximal end of the one or more lead bodies 106 can be plugged to make an electrical connection via connector contacts on the control module 102 and terminals (e.g., 310 in FIG. 3A and 336 of FIG. 3B) on each of the one or more lead bodies 106”; see figure 3A below),
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wherein the implantable device is configured to deliver stimulation energy to the patient via the lead (paragraph 0024 – “The electrical stimulation system or components of the electrical stimulation system, including one or more of the lead bodies 106, the paddle body 104, and the control module 102, are typically implanted into the body of a patient. The electrical stimulation system can be used for a variety of applications including, but not limited to, brain stimulation, neural stimulation, spinal cord stimulation, muscle stimulation, and the like”).
Pianca teaches the conduit as stated above (figure 1, connector 144), but does not explicitly teach a flexible filament integrated with and extending from the housing, the flexible filament comprising one or more wires, optical fibers, or wave guides.
Kallmyer teaches an implantable energy transfer device (figure 4A, 50),
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Which includes a protruding connector 54 from a flexible housing 52, and further includes wires 56 within the flexible housing 52 (figure 4A; paragraph 0070 – “Energy transfer device 34 is an example of energy transfer device 26 of FIG. 1. As shown in FIG. 3A, energy transfer device 34 includes flexible coil 40, phase change material 42, flexible housing 36, and connector portion 38”).
Since Pianca teaches the implantable device comprising the conduit connector with contacts and distal port, and Kallmyer teaches the implantable device comprising the flexible connector with wires as stated above, 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 connector of Pianca, to incorporate the flexible connector material with the wires as taught by Kallmyer, since such modification would predictably result in allowing lead connection to the implantable device.
Re. claim 3, the combined invention of Pianca and Kallmyer (hereinafter the combined invention) further teaches delivering stimulation to the patient via one or more stimulation elements of the lead (Pianca paragraph 0024 – “The electrical stimulation system can be used for a variety of applications including, but not limited to, brain stimulation, neural stimulation, spinal cord stimulation, muscle stimulation, and the like”; paragraph 0059 – “In one embodiment, electrical current is emitted by the electrodes 134 on the paddle or lead body…”; figure 1-2, stimulation electrodes 134).
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Re. claim 11, the combined invention further teaches wherein the implantable device further comprises an antenna within the housing (Pianca figure 8, antenna 818 within a control module; paragraph 0056 – “Some of the components (for example, power source 812, antenna 818, receiver 802, and processor 804) of the electrical stimulation system can be positioned on one or more circuit boards or similar carriers within a sealed housing of an implantable pulse generator, if desired”), and the method further comprises receiving, via the antenna, one or both of power and data from an external device (Pianca paragraph 0041 – “…the housing 105 can contain at least a portion of an implantable telemetry circuit 106, such as a transmitter, a receiver, or a transceiver, configured to wirelessly transfer information electromagnetically using an implantable antenna 110 included at least partially within a dielectric compartment 107. In an example, the external module 115 can include an external antenna 117 coupled to an external telemetry circuit 116”).
Re. claim 12, the combined invention further teaches wherein the conduit is a first conduit, the port is a first port, and the lead is a first lead (Pianca figure 1, connector 144 with a first port and lead),
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The combined invention, specifically the embodiments of Pianca figures 1-2 does not explicitly teach wherein the implantable device further comprises a second conduit extending from the housing and a second port positioned on a distal end of the second conduit comprising a second port and the method further comprising releasably coupling a second lead to the implantable device via the second port.
Pianca in a similar embodiment teaches wherein the implantable device further comprises a second conduit extending from the housing (Pianca similar embodiment figure 3B shows a second conduit connector 322 extending via lead 324 from the housing 352 with first conduit connector 350) and comprising a second port for releasably coupling a second lead to the implantable device via the second port (Pianca figure 3B, connector 322 comprises lead port 330 to couple to second lead 334 by directional arrow 338).
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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 implantable device embodiment of figure 1-2, to incorporate the second conduit connector 322 with the second port 330, as taught by Pianca figure 3B since such modification would predictably result in extending the distance between one or more lead bodies and the control modules (Pianca paragraph 0023 – “A percutaneous lead may be isodiametric along the length of the lead. In addition, one or more lead extensions 324 (e.g., FIG. 3B) can be disposed between the one or more lead bodies 106 and the control module 102 to extend the distance between the one or more lead bodies 106 and the control module 102 of the embodiments shown in FIGS. 1 and 2”).
Re. claim 13, Pianca discloses a system for treating a patient (abstract; paragraph 0001 – “The present invention is directed to the area of implantable electrical stimulation systems and methods of making and using the systems”), comprising:
an implantable device (paragraph 0001 - “The present invention is directed to the area of implantable electrical stimulation systems and methods of making and using the systems”) comprising:
a housing (figure 1, housing 114);
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a conduit integrated with and extending from the housing (figure 1, connector 144 sits above to integrate with the housing 114 and extends from the top of housing 114 to expose the connector 144),
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and a port positioned on a distal end of the conduit (similar embodiment figure 3A shows port 304 on a distal end of the connector 144), wherein the port comprises one or more first contacts (similar embodiment figure 3A shows the port 304 with contacts 314);
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and a lead comprising one or more second contacts configured to couple with the one or more first contacts of the port and configured to releasably couple to the implantable device via the port (paragraph 0023 – “The control module 102 typically includes a connector 144 (FIGS. 2 and 3A, see also 322 and 350 of FIG. 3B) into which the proximal end of the one or more lead bodies 106 can be plugged to make an electrical connection via connector contacts on the control module 102 and terminals (e.g., 310 in FIG. 3A and 336 of FIG. 3B) on each of the one or more lead bodies 106”; see figure 3A below),
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wherein the implantable device is configured to deliver stimulation energy to the patient via the lead (paragraph 0024 – “The electrical stimulation system or components of the electrical stimulation system, including one or more of the lead bodies 106, the paddle body 104, and the control module 102, are typically implanted into the body of a patient. The electrical stimulation system can be used for a variety of applications including, but not limited to, brain stimulation, neural stimulation, spinal cord stimulation, muscle stimulation, and the like”).
Pianca teaches the conduit as stated above (figure 1, connector 144), but does not explicitly teach wherein the conduit comprises a flexible filament comprising one or more wires, optical fibers, or wave guides.
Kallmyer teaches a similar connector for implantable medical devices (Kallmyer abstract – “A body implantable connector for connecting a plurality of implantable devices, such as connecting an extension to a lead”). Kallmyer further teaches the conduit (Kallmyer figure 1, lead connector 12) comprises a flexible filament comprising one or more wires, optical fibers, or wave guides (Kallmyer column 4, lines 7-52: “Connector 12 comprises a sheath 14 and a wire 15. Sheath 14 is open at both ends 26 and 27. Wire 15 is bent to form several projections such as 28 and 29, which projections extends a distance greater from the axis of wire 15 than the radius of wire 15”, the flexible wire 15 shown below) which allows connection from the lead 10 to the conduit 12.
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Both Pianca and Kallmyer teach within the field of connectors for implantable medical devices, specifically with conduit lead connectors. 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 connector conduit of Pianca, to incorporate the flexible wire 15 as taught by Kallmyer, since such modification would predictably result in establishing an electrical connection with the lead and connector (Kallmyer abstract – “A wire extends longitudinally within the sheath and mates with lumens in the conductors of the lead and the extension to make electrical connection between the lead and the extension”), as well as provide structural stability in the conduit connector.
Re. claim 14, the combined invention of Pianca and Kallmyer (hereinafter the combined invention) further teaches wherein the conduit comprises a first conduit, the port comprises a first port, and the lead comprises a first lead (Pianca figure 1, connector 144 with a first port),
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The combined invention, specifically the embodiments of Pianca figures 1-2 does not explicitly teach wherein the implantable device further comprises a second conduit extending from the housing and comprising a second port configured to releasably couple to a second lead.
Pianca of the combined invention in a similar embodiment teaches wherein the implantable device further comprises a second conduit extending from the housing (Pianca similar embodiment figure 3B shows a second conduit connector 322 extending via lead 324 from the housing 352 with first conduit connector 350) and comprising a second port configured to releasably couple to a second lead (Pianca figure 3B, connector 322 comprises lead port 330 to couple to second lead 334 by directional arrow 338).
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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 implantable device embodiment of figure 1, to incorporate the second conduit connector 322 with the second port 330 as taught by Pianca figure 3B since such modification would predictably result in extending the distance between one or more lead bodies and the control modules (Pianca paragraph 0023 – “A percutaneous lead may be isodiametric along the length of the lead. In addition, one or more lead extensions 324 (e.g., FIG. 3B) can be disposed between the one or more lead bodies 106 and the control module 102 to extend the distance between the one or more lead bodies 106 and the control module 102 of the embodiments shown in FIGS. 1 and 2”).
Re. claim 15, the combined invention further teaches wherein the lead comprises one or more stimulation elements configured to deliver the stimulation energy to the patient (Pianca figure 1-2, stimulation electrodes 134).
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Re. claim 16, the combined invention further discloses wherein the one or more second contacts are configured to electrically couple the one or more stimulation elements the implantable device (Pianca figure 1-2, lead 106 connects electrodes 134 to the pulse generator 102; also shown in figure 3A).
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Re. claim 17, the combined invention further teaches wherein the one or more second contacts are positioned on a proximal portion of the lead (Pianca figure 3A, contacts 310 on proximal end of lead 308).
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Re. claim 18, the combined invention further teaches wherein the port is configured to receive the proximal portion of the lead (Pianca figure 3A shows port 304 receiving the proximal portion of lead 308 by arrow 312).
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Re. claim 19, the embodiments of figures 1-2 of Pianca of the combined invention teaches the claimed invention of claim 13 as stated above, but does not explicitly teach the system further comprising an external device comprising a first antenna, wherein the implantable device further comprises a second antenna within the housing, the second antenna configured to receive one or more of power and data from the first antenna.
However, Pianca of the combined invention teaches in a schematic overview of a similar implantable stimulation system 800 comprising:
an external device (Pianca figure 8, external telemetry unit 806; paragraph 0061 – “…the antenna 818 is capable of receiving signals (e.g., RF signals) from an external telemetry unit 806 which is programmed by a programming unit 808”) comprising:
a first antenna (Pianca paragraph 0061 – “The telemetry unit 806 can be a device that is worn on the skin of the user or can be carried by the user and can have a form similar to a pager, cellular phone, or remote control, if desired…The programming unit 808 can be part of the telemetry unit 806 or can provide signals or information to the telemetry unit 806 via a wireless or wired connection. One example of a suitable programming unit is a computer operated by the user or clinician to send signals to the telemetry unit 806”),
wherein the implantable device further comprises a second antenna within the housing (Pianca figure 8, antenna 818 within a control module; paragraph 0056 – “Some of the components (for example, power source 812, antenna 818, receiver 802, and processor 804) of the electrical stimulation system can be positioned on one or more circuit boards or similar carriers within a sealed housing of an implantable pulse generator, if desired”),
the second antenna configured to receive one or more of power and data from the first antenna (Pianca figure 8, antenna 818 receives power from power source 812 and data from telemetry unit 806; paragraph 0058 – “If the power source 812 is a rechargeable battery, the battery may be recharged using the optional antenna 818, if desired. Power can be provided to the battery for recharging by inductively coupling the battery through the antenna to a recharging unit 816 external to the user”; paragraph 0061 – “In one embodiment, the antenna 818 is capable of receiving signals (e.g., RF signals) from an external telemetry unit 806 which is programmed by a programming unit 808”).
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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 stimulation system of combined invention, to incorporate the external device with a first antenna, and second antenna within the implantable housing, as taught by Pianca figure 8, since such modification would predictably result in providing power to the implantable device (Pianca paragraph 0056), or provide signals or information to the implantable device (Pianca paragraph 0061).
Re. claim 29, the combined invention further teaches wherein the one or more first contacts are operatively connected with a controller within the housing of the implantable device (Pianca figures 1-3B, leads with contacts [figure 3A] are operably connected to the connectors of the housing; paragraph 0023 – “The control module 102 typically includes a connector 144 (FIGS. 2 and 3A, see also 322 and 350 of FIG. 3B) into which the proximal end of the one or more lead bodies 106 can be plugged to make an electrical connection via connector contacts on the control module 102 and terminals (e.g., 310 in FIG. 3A and 336 of FIG. 3B) on each of the one or more lead bodies 106”).
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Re. claim 32, Pianca further teaches wherein the implantable device comprises a first implantable device, the method further comprising: detaching the first implantable device from the lead; and releasably coupling a second implantable device to the lead via a port of the second implantable device (Pianca paragraph 0031 – “…a patient with a malfunctioning currently-implanted control module may need to undergo a subsequent surgical procedure to replace the malfunctioning control module. However, the malfunctioning control module may be designed to couple to an eight-terminal lead and the replacement control module may be designed to couple to a sixteen-terminal lead. Thus, the currently-implanted lead may not be readily compatible with the replacement control module.”; figures 1-3B show different implantable devices and leads).
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pianca (US 20120041497 A1 – hereinafter Pianca) [PREVIOUSLY CITED] in view of Kallmyer (US 20130106347 A1 – hereinafter Kallmyer) [NEW], in view of in further view of King (US 20060253174 A1 – hereinafter King) [NEW].
Re. claim 5, the combined invention of Pianca and Kallmyer (hereinafter the combined invention) further teaches wherein the lead comprises a first lead (Pianca figures 1-2, lead 106; figure 3A, lead 308).
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The combined invention does not explicitly teach the method further comprising, prior to implanting the implantable device, replacing a second lead within the patient with the first lead.
King similarly teaches a method for treating a patient (King paragraph 0002 – “The invention is directed to medical devices and, more particularly, medical devices that deliver electrical stimulation”) using an external stimulator (King figure 1, trial stimulator 26) and an implantable medical device (IMD) (King figure 1, IMD 14), and further teaches prior to implanting the implantable device, replacing a second lead within the patient with the first lead (King paragraph 0038 – “Trial stimulator 26 may be used prior to implantation of IMD 14 to determine whether delivery of stimulation by IMD 14 will be efficacious, e.g., relieve symptoms of patient 12. Trial stimulator 26 may be coupled to the same leads 16 as IMD 14 will later be coupled to, or to different leads which will eventually be replaced by leads 16, for delivery of stimulation, e.g., via percutaneous extensions”).
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The combined invention and King all teach within the field of implantable medical systems, specifically for treating a patient. 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 method of the combined invention, to incorporate the step of replacing a second lead within the patient with the first lead as taught by King, since such modification would predictably result in allowing users to determine whether delivery of stimulation by the IMD will be efficacious (King paragraph 0038 – “…to determine whether delivery of stimulation by IMD 14 will be efficacious, e.g., relieve symptoms of patient 12”).
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pianca (US 20120041497 A1 – hereinafter Pianca) [PREVIOUSLY CITED] in view of Kallmyer (US 20130106347 A1 – hereinafter Kallmyer) [NEW] and King (US 20060253174 A1 – hereinafter King) [NEW], and in further view of Moffit (US 20160082254 A1 – hereinafter Moffit) [NEW].
Re. claim 6, the combined invention of Pianca, Kallmyer and King (hereinafter the combined invention) teaches the method of claim 5 of replacing a second lead within the patient with the first lead as stated above, but does not explicitly teach wherein the first lead is used during a first treatment period and the second lead is used during a second, shorter treatment period.
Moffit teaches a similar system for treating a patient comprising an external stimulator with lead 102 (Moffit figures 1A-1B, external stimulator 104 with lead 102),
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and an implantable stimulator with leads 208 (Moffit figure 2, implantable electrical stimulation system 200; paragraph 0068 – “…electrical stimulation system 200 that includes an implantable control module and leads 208 (e.g., a stimulator or pulse generator) 202, one or more leads 208 with electrodes…”).
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Moffit further teaches the wherein the first lead is used during a first treatment period and the second lead is used during a second, shorter treatment period (Moffit paragraph 0058 – “… the patient may undergo successive insertion and stimulation procedures in regular intervals of time. The regular intervals of time between successive stimulation procedures may be at least one month, two months, three months, four months, six months, nine months, a year, eighteen months, two years, or longer”).
The combined invention and Moffit all teach within the field of systems for treating patients, specifically with implantable stimulation systems. 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 system/method of the combined invention, specifically the implantable and external electrical stimulation system leads, to incorporate the first treatment periods as high as two years, and second shorter treatment periods by as low as one month, as taught by Moffit, since such modification would predictably result in providing therapy to a patient (Moffit paragraph 0002 – “The present invention is directed to the area of electrical stimulation systems and methods of using the systems. The present invention is also directed to systems and methods for providing therapy to a patient using intermittent electrical stimulation generated from an electrical stimulation system”).
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pianca (US 20120041497 A1 – hereinafter Pianca) [PREVIOUSLY CITED] in view of Kallmyer (US 20130106347 A1 – hereinafter Kallmyer) [NEW] and King (US 20060253174 A1 – hereinafter King) [NEW], and in further view of Cappa (US 20100048062 A1 – hereinafter Cappa) [PREVIOUSLY CITED].
Re. claim 7, the combined invention of Pianca, Kallmyer and King (hereinafter the combined invention) teaches the method of claim 5 of replacing a second lead within the patient with the first lead as stated above, but does not explicitly teach prior to replacing the second lead, releasably coupling the second lead to an external stimulation device via an attachment assembly.
Cappa discloses a similar electrical stimulation system comprising a first implantable stimulation device (Cappa figure 1, electrical stimulation device 28), and a second, different stimulation device (Cappa paragraph 0041 – “…the PSA 40 is an external testing and measuring device which, for example, can pace the heart…”)
and an attachment assembly (Cappa figure 1, connector block 42), and further teaches prior to replacing the second lead, releasably coupling the second lead to an external stimulation device via an attachment assembly (figure 1, connector block 42 releasably connects to the PSA 40 via lead 44; also shown in figure 8).
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Both the combined invention and Cappa all teach within the field of implantable stimulation systems. 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 stimulation system/method of combined invention, to incorporate the step of releasably coupling the second lead to an external stimulation device via an attachment assembly, as taught by Cappa above, since such modification would predictably result in, for example, allowing a user to “…measure stimulation thresholds, sensing thresholds, and lead impedance” (Cappa paragraph 0041).
Claim(s) 8, 20-21, 24-27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pianca (US 20120041497 A1 – hereinafter Pianca) [PREVIOUSLY CITED] in view of Kallmyer (US 20130106347 A1 – hereinafter Kallmyer) [NEW], and in further view of Cappa (US 20100048062 A1 – hereinafter Cappa) [PREVIOUSLY CITED].
Re. claim 8, combined invention of Pianca and Kallmyer (hereinafter the combined invention) teaches the method of claim 2 as stated above, but does not explicitly teach prior to implanting the first implantable device, delivering stimulation energy to the patient via a second, different stimulation device and the lead.
Cappa discloses a similar electrical stimulation system comprising a first implantable stimulation device (Cappa figure 1, implantable electrical stimulation device 28), and a second, different stimulation device (Cappa figure 1, PSA 40), and further teaches prior to implanting the first implantable device, delivering stimulation energy to the patient via a second, different stimulation device and the lead (Cappa paragraph 0041 – “…the PSA 40 is an external testing and measuring device which, for example, can pace the heart…”; paragraph 0042 – “…the PSA [40] can determine the efficacy of the chosen body tissue site 22 chosen for an electrode 24 at a distal end of a lead 26 intended for connecting an implantable electrical stimulation device 28 to the body tissue”).
Both the combined invention and Cappa all teach within the field of implantable stimulation systems. 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 stimulation system/method of combined invention, to incorporate the step of delivering stimulation energy to the patient via a second, different stimulation device and the lead prior to implanting the first implantable device, as taught by Cappa as stated above, since such modification would predictably result in, for example, allowing a user to “…measure stimulation thresholds, sensing thresholds, and lead impedance” via the PSA, or other second stimulation device (Cappa paragraph 0041).
Re. claim 20, the combined invention of Pianca and Kallmyer (hereinafter the combined invention) further teaches wherein the implantable device is a first stimulation device (Pianca paragraph 0024 – “The electrical stimulation system or components of the electrical stimulation system, including one or more of the lead bodies 106, the paddle body 104, and the control module 102, are typically implanted into the body of a patient”) as stated above in claim 13.
The combined invention does not explicitly teach the system further comprises a second, different stimulation device, and an attachment assembly, wherein the attachment assembly is configured releasably couple the lead to the second stimulation device via a connector thereof.
Cappa discloses a similar electrical stimulation system comprising a first implantable stimulation device (Cappa figure 1, implantable electrical stimulation device 28), and a second, different stimulation device (Cappa paragraph 0041 – “…the PSA 40 is an external testing and measuring device which, for example, can pace the heart…”),
and an attachment assembly (Cappa figure 1, connector block 42), wherein the attachment assembly is configured releasably couple the lead to the second stimulation device via a connector thereof (figure 1, connector block 42 connects to the PSA 40 via lead 44; also shown in figure 8).
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Both the combined invention and Cappa all teach within the field of implantable stimulation systems. 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 stimulation system of combined invention, to incorporate the external stimulator and attachment assembly as taught by Cappa, since such modification would predictably result in, for example, allowing a user to “…measure stimulation thresholds, sensing thresholds, and lead impedance” (Cappa, paragraph 0041).
Re. claim 21, the newly combined invention including Cappa (hereinafter the combined invention) teaches the claimed invention of claim 20 as stated above, and further teaches wherein the second stimulation device is an external stimulation device (Cappa figure 1, external stimulator 40, paragraph 0041 – “…the PSA 40 is an external testing and measuring device which, for example, can pace the heart during the implantation procedure and can measure stimulation thresholds, sensing thresholds, and lead impedance).
Re. claim 24, the combined invention further discloses wherein the attachment device further comprises a recess configured to receive a portion of the lead (Cappa figure 5, lead 26 fitted within recess of connector block 42).
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Re. claim 25, the combined invention further discloses wherein the attachment assembly further comprises a clip having one or more hinged portions that configure the clip to transition between an open configuration and a closed configuration (Cappa figures 8-9, hinge mechanism 60 of the connector block 42).
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Re. claim 26, the combined invention further discloses wherein, in the closed configuration, the clip secures the portion of the lead within the attachment assembly (Cappa figure 8 shows the lead 26 secured in the closed configuration of the connector block 42).
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Re. claim 27, the combined invention further discloses wherein the attachment assembly further comprises a projection configured to engage a recess of the clip, and wherein the clip transitions from the open configuration to the closed configuration when the projection is engaged with the recess (figures 7-10, switch handle 66 through opening 96 in closed position; paragraph 0049 – “…switch handle 66 is pivotally mounted on the cover 86 beneath the lower surface 94 and projects through the opening 96 to a location above the upper surface 92”).
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Claim(s) 9-10 and 22-23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pianca (US 20120041497 A1 – hereinafter Pianca) in view of Kallmyer (US 20130106347 A1 – hereinafter Kallmyer) [NEW], and Cappa (US 20100048062 A1 – hereinafter Cappa), and in further view of Moffit (US 20160082254 A1 – hereinafter Moffit).
Re. claim 9, the combined invention of Pianca, Kallmyer and Cappa (hereinafter the combined invention) teaches the claimed invention of claim 8 as stated above, but does not explicitly teach wherein the first stimulation device is used during a first treatment period and the second stimulation device is used during a second, shorter treatment period.
Moffit teaches a similar system for treating a patient comprising an external stimulator (Moffit figures 1A-1B, external stimulator 104),
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and an implantable stimulator (Moffit figure 2, implantable electrical stimulation system 200; paragraph 0068 – “…electrical stimulation system 200 that includes an implantable control module (e.g., a stimulator or pulse generator) 202, one or more leads 208 with electrodes…”).
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Moffit further teaches wherein the first stimulation device is used during a first treatment period and the second stimulation device is used during a second, shorter treatment period (Moffit paragraph 0058 – “… the patient may undergo successive insertion and stimulation procedures in regular intervals of time. The regular intervals of time between successive stimulation procedures may be at least one month, two months, three months, four months, six months, nine months, a year, eighteen months, two years, or longer”).
The combined invention and Moffit all teach within the field of systems for treating patients, specifically with implantable stimulation systems. 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 system/method of the combined invention, specifically the implantable and external electrical stimulation systems, to incorporate the first treatment periods as high as two years, and second shorter treatment periods by as low as one month, as taught by Moffit stated above, since such modification would predictably result in providing therapy to a patient (Moffit paragraph 0002 – “The present invention is directed to the area of electrical stimulation systems and methods of using the systems. The present invention is also directed to systems and methods for providing therapy to a patient using intermittent electrical stimulation generated from an electrical stimulation system”).
Re. claim 10, the newly combined invention including Moffit further teaches wherein the first treatment period is at least 3 months, and the second treatment period is less than 3 months (Moffit paragraph 0058 – “… the patient may undergo successive insertion and stimulation procedures in regular intervals of time. The regular intervals of time between successive stimulation procedures may be at least one month, two months, three months, four months, six months, nine months, a year, eighteen months, two years, or longer”).
Re. claim 22, the combined invention of Pianca, Kallmyer and Cappa (hereinafter the combined invention) teaches the claimed invention of claim 20 as stated above, but does not explicitly teach wherein the first stimulation device is configured to be used during a first treatment period and the second stimulation device is configured to be used during a second, shorter treatment period.
Moffit teaches a similar system for treating a patient comprising an external stimulator (Moffit figures 1A-1B, external stimulator 104),
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and an implantable stimulator (Moffit figure 2, implantable electrical stimulation system 200; paragraph 0068 – “…electrical stimulation system 200 that includes an implantable control module (e.g., a stimulator or pulse generator) 202, one or more leads 208 with electrodes…”).
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Moffit further teaches wherein the first stimulation device is configured to be used during a first treatment period and the second stimulation device is configured to be used during a second, shorter treatment period (Moffit paragraph 0058 – “… the patient may undergo successive insertion and stimulation procedures in regular intervals of time. The regular intervals of time between successive stimulation procedures may be at least one month, two months, three months, four months, six months, nine months, a year, eighteen months, two years, or longer”).
The combined invention and Moffit all teach within the field of systems for treating patients, specifically with implantable stimulation systems. 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 system of the combined invention, specifically the implantable and external electrical stimulation systems, to incorporate the first treatment periods as high as two years, and second shorter treatment periods by as low as one month, as taught by Moffit stated above, since such modification would predictably result in providing therapy to a patient (Moffit paragraph 0002 – “The present invention is directed to the area of electrical stimulation systems and methods of using the systems. The present invention is also directed to systems and methods for providing therapy to a patient using intermittent electrical stimulation generated from an electrical stimulation system”).
Re. claim 23, the newly combined invention including Moffit further teaches wherein the first treatment period is at least 3 months and the second treatment period is less than 3 months (Moffit paragraph 0058 – “… the patient may undergo successive insertion and stimulation procedures in regular intervals of time. The regular intervals of time between successive stimulation procedures may be at least one month, two months, three months, four months, six months, nine months, a year, eighteen months, two years, or longer”).
Claim(s) 28 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pianca (US 20120041497 A1 – hereinafter Pianca) [PREVIOUSLY CITED] in view of Kallmyer (US 20130106347 A1 – hereinafter Kallmyer) [NEW], and in further view of Meskins (US 20120109256 A1 – hereinafter Meskins) [PREVIOUSLY CITED].
Re. claim 28, the combined invention of Pianca and Kallmyer (hereinafter the combined invention) teaches the claimed invention of claim 13 as stated above, but does not explicitly teach wherein the housing of the implantable device comprises a volume of less than or equal to 2,000 mm3.
Meskins discloses a communication system for implantable medical device (Meskins abstract – “A communication system for an active implantable medical device”), and further teaches in figure 2, an active implantable medical device (AIMD) 55 comprising an implantable component 100 with a housing/casing 102, wherein the housing of the implantable device comprises a volume of less than or equal to 2,000 mm3 (Meskins paragraph 0026 – “…as shown in FIG. 2, the presence of the additional MI radio coil 151 would require additional feedthroughs 107 in the casing 102 of implantable component 100 and increase the total area and volume of implantable component 100 (by, e.g., 400 mm.sup.2 or 1600 mm.sup.3)”).
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The combined invention and Meskins all teach within the field of implantable medical devices. 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 implantable combined invention, specifically the housing volume of the implantable medical device, to incorporate the housing volume of less than or equal to 2,000 mm3 as taught by Meskins, since such modification would predictably result in allowing additional components to the housing of the implantable medical system (i.e. an additional coil as per Meskins paragraph 0026).
Claim(s) 31 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pianca (US 20120041497 A1 – hereinafter Pianca) [PREVIOUSLY CITED] in view of Kallmyer (US 20130106347 A1 – hereinafter Kallmyer) [NEW], and in further view of Belden (US 20030018364 A1 – hereinafter Belden) [PREVIOUSLY CITED].
Re. claim 31, the combined invention of Pianca and Kallmyer (hereinafter the combined invention) teaches the claimed invention of claim 13 as stated above, but does not explicitly teach wherein the implantable device further comprises a sleeve or a collar configured to create a seal between the lead and the port.
Belden teaches an implantable medical device (Belden abstract), where in figure 5 shows a connector block 12, lead 122, and a protective sleeve 128 that is wrapped around low-profile lead body 122 after insertion of its proximal end into strain relief zone/port 106 (Belden paragraph 0037). Slits 130 and region 132 allow for the protective sleeve to roll over itself to seal the lead and create a sleeve or a collar configured to create a seal between the lead and the port (Belden paragraph 0037 – “Protective sleeve 128 has longitudinal slit 130 that has overlapping design 132 that, when in place within strain relief zone 106, compresses the edges of protective sleeve 128 together”; see figure 5 below).
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Since Belden and the combined invention are within the field of implantable medical devices, 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 implantable medical device of the combined invention, specifically the lead and the port, to incorporate the protective sleeve 128 as taught by Belden since such modification would predictably result in providing additional sealing to prevent ingress of body fluids into the bore (Belden paragraph 0037).
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Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Anh-Khoa N. Dinh whose telephone number is (571)272-7041. The examiner can normally be reached Mon-Fri 7:00am-4:00pm EST.
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/ANH-KHOA N DINH/Examiner, Art Unit 3796
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