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 .
Election/Restrictions
Applicant’s election without traverse of Invention I in the reply filed on 11/12/2025 is acknowledged. Applicant has cancelled the claims of the non-elected invention.
Specification
The disclosure is objected to because of the following informalities: Paragraph [0058] lines 9-10 disclose “external coil 103”; this reference number is used in the disclosure as the headset and should be changed to 104.
Appropriate correction is required.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-2, 8-10, 12-15, 22, 24-26, and 29 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Reed et al (US Publication 2017/0252568).
Referring to Claim 1, Reed et al teaches a system, comprising: at least two implantable devices (e.g. Figure 19, Elements 10a and Paragraph [0269] disclose implants on left and right side of the head); an external system configured to communicate with each of the at least two implantable devices (e.g. Figure 19, Element 1908 and Paragraph [0269] discloses charger/processor body 1908 which contains processor circuitry and batteries for both charging the internal battery in the implants 10a and also communicating with the implants 10a); a programmer configured to communicate with the external system, the programmer including: a user interface, the user interface including a display (e.g. Figure 8A, handheld unit 40 and Paragraph [0269] discloses for communication, an external interface is provided to the user via the handheld unit described in FIGS. 8A and 8B); a processor configured to provide on the display (e.g. Figure 8, Elements 42-44 and Paragraph [0243] discloses monitoring and displaying recharge level along with toggling, selecting and adjusting of stimulation via buttons and therefore necessarily includes a processor): implantable device icons corresponding to each of the at least two implantable devices, an external system icon corresponding to the external system (e.g. Figure 8A and Paragraph [0243] discloses display area 42 for depicting a left icon depicting the level on the left implant and a right icon depicting the level on the right implant; and icon 43 depicting a recharge level of the external charging system and Paragraph [0269] discloses 1908 is the body containing batteries for charging the internal battery in the implants), wireless link representations corresponding to wireless links between the external system and each of the at least two implantable devices, wherein the system is configured to use the wireless links for at least one of communication or power transfer (e.g. Figure 8A, Element 42 illustrates the charge level of each neurostimulator system).
Referring to Claim 2, Reed et al teaches the system of claim 1, wherein the wireless representations provide a status indicator for a current status for each of the wireless links (e.g. Figure 8A, Elements 42 and 43 provide a status of the wireless links by providing the charge level).
Referring to Claim 8, Reed et al teaches the system of claim 1, wherein each of the implantable devices include a rechargeable battery (e.g. Paragraphs [0010] and [0269] discloses the IPG having rechargeable batteries), and the processor is further configured to provide on the display charge state representations for the rechargeable battery in each of the implantable devices (e.g. Figure 8, Elements 42).
Referring to Claim 9, Reed et al teaches the system of claim 1, wherein each of the at least two implantable devices are configured to be programmed with a stimulation configuration, wherein the processor is configured to guide a user with acceptable programming inputs when programming the stimulation configuration (e.g. Figure 8A, programmer 40 and Paragraph [0243] discloses the programmer allows the user to increase/decrease the level of stimulation).
Referring to Claim 10, Reed et al teaches the system of claim 9, wherein the stimulation configuration includes an electrode configuration and an amplitude configuration (e.g. Figure 8A, programmer 40 and Paragraph [0243] discloses the programmer allows the user to increase/decrease the level of stimulation).
Referring to Claim 12, Reed et al teaches the system of claim 9, wherein the processor is configured to guide the user to select allowable amplitudes for a selected electrode configuration (e.g. Figure 8A, programmer 40 and Paragraphs [0208] and [0243] discloses the programmer allows the user to increase/decrease the level of stimulation).
Referring to Claim 13, Reed et al teaches a system, comprising: at least two implantable devices (e.g. Figure 19, Elements 10a and Paragraph [0269] disclose implants on left and right side of the head), each of the at least two implantable devices being configured to deliver stimulation to different regions of a body according to different stimulation configurations (e.g. Figure 8A, programmer 40 and Paragraph [0243] discloses the programmer allows the user to increase/decrease the level of stimulation); an external system configured to communicate with each of the at least two implantable devices (e.g. Figure 19, Element 1908 and Paragraph [0269] discloses charger/processor body 1908 which contains processor circuitry and batteries for both charging the internal battery in the implants 10a and also communicating with the implants 10a); a programmer configured to communicate with the external system, the programmer being configured for use to program the at least two implantable devices by associating the different stimulation configurations with the different regions of the body, and receiving programming inputs for the different stimulation configurations associated with the different regions of the body, wherein the programmer includes a user interface, and the user interface includes a display that includes identifiers for each of the different regions of the body and includes the different stimulation configurations associated with the different regions (e.g. Figure 8A, handheld unit 40, display area 42 for depicting a left icon depicting the level on the left implant and a right icon depicting the level on the right implant and Paragraph [0269] discloses for communication, an external interface is provided to the user via the handheld unit described in FIGS. 8A and 8B).
Referring to Claim 14, Reed et al teaches the system of claim 13, wherein the different regions include a left orbital region, a right orbital region, a left occipital region and a right occipital region (e.g. Figure 19, frontal electrode array 25 (for orbital nerve), and occipital lead 30b and Paragraph [0243] discloses a first frontal section including the supraorbital nerve region, a medial section including the parietal nerve region and a distal section that includes the occipital nerves).
Referring to Claim 15, Reed et al teaches the system of claim 13, wherein the display includes, for each of the different regions, an electrode configuration, an amplitude, a pulse width and a frequency (e.g. Figure 8A and Paragraph [0218] discloses pulse amplitude, frequency and pulse width and Paragraph [0243] discloses the programmer allows the user to increase/decrease the level of stimulation; therefore changing the electrode configuration).
Referring to Claim 22, Reed et al teaches a method performed in a system having at least two implantable devices (e.g. Figure 19, Elements 10a and Paragraph [0269] disclose implants on left and right side of the head), an external system configured to communicate with each of the at least two implantable devices (e.g. Figure 19, Element 1908 and Paragraph [0269] discloses charger/processor body 1908 which contains processor circuitry and batteries for both charging the internal battery in the implants 10a and also communicating with the implants 10a), and a programmer configured to communicate with the external system (e.g. Figure 8A, handheld unit 40, display area 42 for depicting a left icon depicting the level on the left implant and a right icon depicting the level on the right implant and Paragraph [0269] discloses for communication, an external interface is provided to the user via the handheld unit described in FIGS. 8A and 8B), wherein the method includes: displaying a representation of the system on the display (e.g. Figure 8A, display 41); and performing at least one of: determining a link status for at least links between the external system and the implantable devices, displaying the link status within the displayed representation of the system; or determining a status of rechargeable batteries, and displaying the rechargeable battery status within the displayed representation of the system (e.g. Figure 8A, Element 42 illustrates the charge level of each neurostimulator system).
Referring to Claim 24, Reed et al teaches the method of claim 22, further comprising guiding selection of an allowable stimulation configuration for the system (e.g. Figure 8A, programmer 40 and Paragraph [0243] discloses the programmer allows the user to increase/decrease the level of stimulation).
Referring to Claim 25, Reed et al teaches the method of claim 22, wherein displaying the representation of the system includes displaying implantable device icons corresponding to each of the at least two implantable devices, an external system icon corresponding to the external system (e.g. Figure 8A and Paragraph [0243] discloses display area 42 for depicting a left icon depicting the level on the left implant and a right icon depicting the level on the right implant; and icon 43 depicting a recharge level of the external charging system and Paragraph [0269] discloses 1908 is the body containing batteries for charging the internal battery in the implants), and wireless link representations corresponding to wireless links between the external system and each of the at least two implantable devices (e.g. Figure 8A, Element 42 illustrates the charge level of each neurostimulator system).
Referring to Claim 26, Reed et al teaches the method of claim 25, wherein the external system includes a headset (e.g. Figure 19, Element 1902) having at least two external coils (e.g. Figure 19, Elements 1904 and 1906), and wherein the method further comprises displaying status indicators for corresponding wireless links between each of the at least two external coils and the at least two implantable devices (e.g. Figure 8A and Paragraph [0243] discloses display area 42 for depicting a left icon depicting the level on the left implant and a right icon depicting the level on the right implant; and icon 43 depicting a recharge level of the external charging system).
Referring to Claim 29, Reed et al teaches the method of claim 22, wherein each of the at least two implantable devices is configured to be programmed with a stimulation configuration, and wherein the method further comprises guiding a user with acceptable programming inputs when programming the stimulation configuration (e.g. Figure 8A, programmer 40 and Paragraph [0243] discloses the programmer allows the user to increase/decrease the level of stimulation).
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 3-5, 23, and 27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Reed et al (US Publication 2017/0252568) in view of Wenning et al (US Publication 2023/0191141).
Referring to Claim 3, Reed et al teaches the system of claim 2, except wherein the processor is configured to provide on the display a suggested action to remedy a problem with the wireless status. Wenning et al teaches that it is known to use a display of the alignment between coils and an indication of how the charging coil should be moved to improve alignment as set forth in Figures 16 and 17, Elements 1600 and 1500 to provide improved wireless efficiency as the coils become more concentrically aligned. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Reed et al, with processor is configured to provide on the display a suggested action to remedy a problem with the wireless status as taught by Wenning et al, since such a modification would provide the predictable results of improved wireless efficiency as the coils become more concentrically aligned.
Referring to Claim 4, Reed et al teaches the system of claim 1, wherein the external system includes a headset (e.g. Figure 19, Element 1902), and the headset includes at least two external coils (e.g. Figure 19, Elements 1904 and 1906), wherein the external system (e.g. Figure 19, Element 1908) is configured to provide wireless links, wherein the wireless links include a first link between a first one of the external coils and a first one of the implantable devices, and a second link between a second one of the external coils and a second one of the implantable devices (e.g. Figure 19 and Paragraph [0269] discloses headset 1902 includes right and left coupling coil enclosures 1904 and 1906, respectively that contain coils coupled to the respective coils in the implants 10a), wherein the wireless link representations provide status indicators for corresponding wireless links between each of the at least two external coils and the at least two implantable devices (e.g. Figure 8A, Elements 42 illustrates a display of charge level and therefore provides a status indicator that the wireless link is made).
In the alternative that the status indicator for corresponding wireless links is an indication of alignment. Wenning et al teaches that it is known to use a display of the alignment between coils and an indication of how the charging coil should be moved to improve alignment as set forth in Figures 16 and 17, Elements 1600 and 1500 to provide improved wireless efficiency as the coils become more concentrically aligned. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Reed et al, with the wireless link representations provide status indicators for corresponding wireless links between each of the external coil and the implantable device as taught by Wenning et al, since such a modification would provide the predictable results of improved wireless efficiency as the coils become more concentrically aligned.
Referring to Claim 5, Reed et al in view of Wenning et al teaches the system of claim 4, except wherein the processor is configured to provide on the display a suggestion to align a specific one of the external coils when the status indictor for the wireless link corresponding to the specific one of the coils indicates misalignment.
Wenning et al teaches that it is known to use a display of the alignment between coils and an indication of how the charging coil should be moved to improve alignment as set forth in Figures 16 and 17, Elements 1600 and 1500 to provide improved wireless efficiency as the coils become more concentrically aligned. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Reed et al, with the processor configured to provide on the display a suggestion to align a specific one of the external coils when the status indictor for the wireless link corresponding to the specific one of the coils indicates misalignment as taught by Wenning et al, since such a modification would provide the predictable results of improved wireless efficiency as the coils become more concentrically aligned.
Referring to Claim 23, Reed et al teaches the method of claim 22, except further comprising suggesting remedial action for the determined link status or the determined status of rechargeable batteries.
Wenning et al teaches that it is known to use a display of the alignment between coils and an indication of how the charging coil should be moved to improve alignment as set forth in Figures 16 and 17, Elements 1600 and 1500 to provide improved wireless efficiency as the coils become more concentrically aligned. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the method as taught by Reed et al, with suggesting remedial action for the determined link status or the determined status of rechargeable batteries as taught by Wenning et al, since such a modification would provide the predictable results of improved wireless efficiency as the coils become more concentrically aligned.
Referring to Claim 27, Reed et al teaches the method of claim 26, except further comprising providing on the display a suggestion to align a specific one of the external coils when the status indicator for the wireless link corresponding to the specific one of the coils indicates misalignment.
Wenning et al teaches that it is known to use a display of the alignment between coils and an indication of how the charging coil should be moved to improve alignment as set forth in Figures 16 and 17, Elements 1600 and 1500 to provide improved wireless efficiency as the coils become more concentrically aligned. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the method as taught by Reed et al, with providing on the display a suggestion to align a specific one of the external coils when the status indicator for the wireless link corresponding to the specific one of the coils indicates misalignment as taught by Wenning et al, since such a modification would provide the predictable results of improved wireless efficiency as the coils become more concentrically aligned.
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Reed et al (US Publication 2017/0252568) in view of Wenning et al (US Publication 2023/0191141), as applied above, and further in view of Rondoni et al (US Publication 2015/0367136).
Referring to Claim 6, Reed et al in view of Wenning et al teaches the system of claim 4, except wherein the external system includes an external device configured to be connected to the headset via a cable, wherein the processor is configured to provide on the display a cable representation corresponding to a connection of the cable between the headset and the external device, and the processor configured to provide on the display, when a status indicator for the cable representation indicates a failed connection between the headset and the external device, a suggestion to remedy the failed connection. Rondoni et al teaches that it is known to use a cable to connect two devices and wherein the processor is configured to provide on the display a cable representation corresponding to a connection of the cable between the devices, and the processor configured to provide on the display, when a status indicator for the cable representation indicates a failed connection between the devices, a suggestion to remedy the failed connection as set forth in Paragraph [0050] to provide a more secure connection that is less likely to be subject to interference and to provide improved problem solving when the issue is a result of cable connection issues. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Reed et al, with a cable to connect two devices and wherein the processor is configured to provide on the display a cable representation corresponding to a connection of the cable between the devices, and the processor configured to provide on the display, when a status indicator for the cable representation indicates a failed connection between the headset and the external device, a suggestion to remedy the failed connection as taught by Rondoni et al, since such a modification would provide the predictable results of a more secure connection that is less likely to be subject to interference and to provide improved problem solving when the issue is a result of cable connection issues.
Claim(s) 7 and 28 is/are rejected under 35 U.S.C. 103 as being unpatentable over Reed et al (US Publication 2017/0252568) in view of Rondoni et al (US Publication 2015/0367136).
Referring to Claim 7, Reed et al teaches the system of claim 1, except wherein the processor is further configured to provide on the display a programmer icon corresponding to the programmer, wherein the communication link representations further include a communication link representation corresponding to a communication link between the programmer icon and the external system icon.
Rondoni et al teaches that it is known to use a cable to connect two devices and wherein the processor is configured to provide on the display a representation corresponding to a connection between the devices, and the processor configured to provide on the display a link representation, as set forth in Paragraph [0050] to provide a more secure connection that is less likely to be subject to interference and to provide easy identification of the connection status. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Reed et al, with a cable to connect two devices and wherein the processor is configured to provide on the display a cable representation corresponding to a connection of the cable between the devices, and the processor configured to provide on the display, when a status indicator for the cable representation indicates a failed connection between the headset and the external device, a suggestion to remedy the failed connection as taught by Rondoni et al, since such a modification would provide the predictable results of more secure connection that is less likely to be subject to interference and to provide easy identification of the connection status.
Referring to Claim 28, Reed et al teaches the method of claim 25, except wherein the external system includes an external device configured to be connected to a headset via a cable, and wherein the method further comprises displaying a cable representation corresponding to a connection of the cable between the headset and the external device, and providing on the display, when a status indicator for the cable representation indicates a failed connection, a suggestion to remedy the failed connection.
Rondoni et al teaches that it is known to use a cable to connect two devices and wherein the processor is configured to provide on the display a cable representation corresponding to a connection of the cable between the devices, and the processor configured to provide on the display, when a status indicator for the cable representation indicates a failed connection between the devices, a suggestion to remedy the failed connection as set forth in Paragraph [0050] to provide a more secure connection that is less likely to be subject to interference and to provide improved problem solving when the issue is a result of cable connection issues. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the method as taught by Reed et al, with a cable to connect two devices and wherein the processor is configured to provide on the display a cable representation corresponding to a connection of the cable between the devices, and the processor configured to provide on the display, when a status indicator for the cable representation indicates a failed connection between the headset and the external device, a suggestion to remedy the failed connection as taught by Rondoni et al, since such a modification would provide the predictable results of a more secure connection that is less likely to be subject to interference and to provide improved problem solving when the issue is a result of cable connection issues.
Claim(s) 11 and 30 is/are rejected under 35 U.S.C. 103 as being unpatentable over Reed et al (US Publication 2017/0252568) in view of Lee et al (US Publication 2004/0199216).
Referring to Claim 11, Reed et al teaches the system of claim 9, wherein the electrodes are designated as an anode or a cathode and any combination (e.g. Paragraphs [0200]-[0201], and [0208]). However, Reed et al does not explicitly disclose wherein the processor is configured to guide the user to select at least one anode electrode and at least one cathode electrode. Lee et al teaches that it is known to use the processor (of the programmer) is configured to guide the user to select at least one anode electrode and at least one cathode electrode as set forth in Paragraphs [0008] and [0058] to provide improved customization of the therapy to improve the efficacy while minimizing the side effects associated with the therapy. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Reed et al, with the processor is configured to guide the user to select at least one anode electrode and at least one cathode electrode as taught by Lee et al, since such a modification would provide the predictable results of improved customization of the therapy to improve the efficacy while minimizing the side effects associated with the therapy.
Referring to Claim 30, Reed et al teaches the method of claim 29, wherein the stimulation configuration includes an electrode configuration and an amplitude configuration (e.g. Figure 8A, programmer 40 and Paragraphs [0208] and [0243] discloses the programmer allows the user to increase/decrease the level of stimulation), and wherein the electrodes are designated as an anode or a cathode and any combination (e.g. Paragraphs [0200]-[0201], and [0208]). However, Reed et al does not explicitly disclose wherein guiding the user comprises guiding the user to select at least one anode electrode and at least one cathode electrode. Lee et al teaches that it is known to use the processor (of the programmer) is configured to guide the user to select at least one anode electrode and at least one cathode electrode as set forth in Paragraphs [0008] and [0058] to provide improved customization of the therapy to improve the efficacy while minimizing the side effects associated with the therapy. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the method as taught by Reed et al, with the processor is configured to guide the user to select at least one anode electrode and at least one cathode electrode as taught by Lee et al, since such a modification would provide the predictable results of improved customization of the therapy to improve the efficacy while minimizing the side effects associated with the therapy.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Hansen et al (US Publication 2018/0078329) discloses displaying a degree of coupling between an external coil and an implanted coil.
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/William J Levicky/Primary Examiner, Art Unit 3796