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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 09/16/2026 is being considered by the examiner.
Response to Amendment
The amendment filed 09/09/2026 has been entered. Claims 2-22 remain pending in the application. Applicant’s amendments to the Specification, Drawings, and Claims have overcome each and every objection and 112(b) rejection previously set forth in the Non-Final Office Action mailed 06/09/2026. More details below.
Response to Arguments
Drawing Objections:
Applicant amended drawings and addressed all previous drawings objections and the objections have been withdrawn.
Specification Objections:
Applicant amended specification and addressed all previous specification objections and the objections have been withdrawn.
Claim Objections:
Applicant amended claims and addressed all previous claim objections and the objections have been withdrawn.
35 USC § 112(b):
Claims 2, 13, and 14 have been amended, therefore the previous 112(b) rejection is withdrawn.
Claim 10 has been amended, therefore the previous 112(b) rejection is withdrawn.
35 USC § 103:
Applicant’s arguments, see pg. 13-15, filed September, with respect to the rejection(s) of claims 2-7, 9-18, and 20-22 under 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Woods et al. (US 20030114899 A1).
Applicant’s arguments, see pg. 15-16, filed September, with respect to the rejection(s) of claims 8 and 19 under 103 have been fully considered but they are not persuasive.
On pg. 15 of applicant’s response applicant argues that James does not disclose “using memory T-cell levels as a biomarker for inflammation”. Although James does not explicitly disclose using the memory T-cells as a biomarker for inflammation, James teaches that the memory T-cells were at a higher frequency in rheumatoid arthritis patients, thus providing information associated with the inflammatory response in the disease (Fig. 3C, pg. 6). Therefore, it would have been obvious for a person of ordinary skill in the art to have modified Huston’s biomarker for inflammation to incorporate the teachings of James listed, and provide memory T cells. Doing so would have enabled monitoring of cytokine and memory T cell levels to identify trends that could indicate the effectiveness of the neural stimulation treatment to the user (para. 0051, 0083).
Double Patenting:
Applicant’s arguments, see pg. 11-13, filed September , with respect to the rejection(s) of claims 2-22 for double patenting, have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Huston et al. (US 20060178703 A1), and in further view of Whitehurst et al. (US 20110077721 A1), and Woods et al. (US 20030114899 A1),
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 2-12 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 and 12 of U.S. Patent No. 12121726 B2 view of Huston et al. (US 20060178703 A1), hereinafter Huston, and in further view of Whitehurst et al. (US 20110077721 A1), hereinafter Whitehurst, and Woods et al. (US 20030114899 A1), hereinafter Woods. The claims of the instant application and the claims of the reference patent are compared in the table below.
Instant Application
U.S. Patent 12121726 B2
2. A system for treating rheumatoid arthritis, the system comprising: an implantable microstimulator configured to apply neural stimulation to a cholinergic anti-inflammatory pathway (NCAP); an external programmer configured to communicate with the implantable microstimulator; and a non-transitory computer-readable medium including computer-program instructions, that, when executed by one or more processors, perform a computer-implemented method comprising: receiving, via a mobile device, user input for delaying or cancelling a scheduled dosing delivered by the implantable microstimulator to treat rheumatoid arthritis;
1. A system for treating inflammation, the system comprising: an implantable microstimulator configured to apply neural stimulation to a cholinergic anti- inflammatory pathway (NCAP); an external programmer configured to communicate with the implantable microstimulator; and a non-transitory computer-readable medium including computer-program instructions, that, when executed by one or more processors, perform a computer-implemented method comprising: presenting a user interface for adjusting stimulation parameters of the implantable microstimulator; receiving user input for adjusting or delaying dosing delivered by the implantable microstimulator;
receiving, via the mobile device, a pairing-status indicator from the external programmer indicating that the external programmer is paired with the implantable microstimulator; and transmitting the user input from the mobile device to the external programmer for transmission to the implantable microstimulator based on the pairing- status indicator
confirming that the external programmer is paired with the implantable microstimulator before transmitting the user input; and transmitting the user input indirectly to the implantable microstimulator through the external programmer when the external programmer is paired with the implantable microstimulator.
3. The system of claim 2, wherein the implantable microstimulator is a leadless implantable microstimulator.
2. The system of claim 1, wherein the implantable microstimulator is a leadless implantable microstimulator.
4. The system of claim 2, wherein the non-transitory computer-readable medium is configured to execute on a user's mobile device.
3. The system of claim 1, wherein the non-transitory computer-readable medium is configured to execute on a user's mobile device.
5. The system of claim 2, wherein the external programmer comprises a charger.
4. The system of claim 1, wherein the external programmer comprises a charger.
6. The system of claim 2, wherein the computer-implemented method further comprises receiving data associated with a patient metric and adjusting the dosing based on the patient metric.
5. The system of claim 1, wherein the computer-implemented method further comprises receiving data associated with a patient metric and adjusting the dosing based on the patient metric.
7. The system of claim 6, wherein the patient metric comprises a biomarker for inflammation.
6. The system of claim 5, wherein the patient metric comprises a biomarker for inflammation.
8. The system of claim 7, wherein the biomarker for inflammation comprises a cytokine level and/or a memory T cell level.
7. The system of claim 6, wherein the biomarker for inflammation comprises a cytokine level and/or a memory T cell level.
9. The system of claim 6, wherein the patient metric comprises an activity metric or a physiological metric.
8. The system of claim 5, wherein the patient metric comprises an activity metric or a physiological metric.
10. The system of claim 2, further comprising receiving, from the user interface, an emergency stop command and transmitting the emergency stop directly to the implantable microstimulator.
9. The system of claim 1, further comprising receiving, from the user interface, an emergency stop command and transmitting the emergency stop directly to the implantable microstimulator.
11. The system of claim 2, wherein receiving user input for adjusting or delaying dosing delivered by the implantable microstimulator comprises receiving the user input when the external programmer is not in communication with the implantable microstimulator.
10. The system of claim 1, wherein receiving user input for adjusting or delaying dosing delivered by the implantable microstimulator comprises receiving the user input when the external programmer is not in communication with the implantable microstimulator.
12. The system of claim 2, wherein the external programmer is configured to prevent improper modification of dosing.
12. The system of claim 1, wherein the external programmer is configured to prevent improper modification of dosing.
Claim 1 of the reference patent recites all the limitations of claim 1 of the instant application except “treating rheumatoid arthritis, receiving user input, via a mobile device, receiving, via the mobile device, a pairing-status indicator from the external programmer indicating that the external programmer is paired with the implantable microstimulator; and transmitting the user input from the mobile device to the external programmer for transmission to the implantable microstimulator based on the pairing- status indicator”.
However, Huston teaches treating rheumatoid arthritis (para. 0066 (condition can be mediated by a localized inflammatory cytokine cascade, as in rheumatoid arthritis)). It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to treat rheumatoid arthritis, as disclosed in Huston, within the system of claim 1 to enable treatment of rheumatoid arthritis by applying neural stimulation to modulate the inflammatory response associated with the disease. Doing so would reduce levels of pro-inflammatory cytokines and expand the therapeutic applicability of Skelton’s system and method.
Huston does not teach receiving user input, via a mobile device, receiving, via the mobile device, a pairing-status indicator from the external programmer indicating that the external programmer is paired with the implantable microstimulator; and transmitting the user input from the mobile device to the external programmer for transmission to the implantable microstimulator based on the pairing- status indicator.
However, Whitehurst teaches receiving, via a mobile device (Fig. 4, element 218 – telephone modem), user input for delaying or cancelling a scheduled dosing delivered by the implantable microstimulator (para. 0106 (external programmer 200 is provided with an interface means 216 for interacting with other computing means 218, such as by a serial interface cable or infrared link to a personal computer or to a telephone modem or the like. Such interface means 216 may permit a clinician to monitor the status of the implant and prescribe new stimulation parameters from a remote location)); and
transmitting the user input from the mobile device to the external programmer for transmission to the implantable microstimulator (para. 0106 (external programmer 200 is provided with an interface means 216 for interacting with other computing means 218, such as by a serial interface cable or infrared link to a personal computer or to a telephone modem or the like. Such interface means 216 may permit a clinician to monitor the status of the implant and prescribe new stimulation parameters from a remote location)).
Whitehurst does not teach receiving, via the mobile device, a pairing-status indicator from the external programmer indicating that the external programmer is paired with the implantable microstimulator, and transmitting user input based on the pairing- status indicator.
However, Woods teaches receiving, via an external device (Fig. 1, element 204), a pairing-status indicator (Fig. 7C, element 250 – status icon) from an external programmer (Fig. 1, element 202 – hand held programmer) indicating that the external programmer is paired with an implantable medical device (Fig. 1, element 100, para. 0189 (status icons 250 are provided that display the status of the patient-programmer-to-implant link and the patient-programmer-to-clinician-programmer link), 0164 (a communication link status between devices is always depicted on a screen associated with the programmer 204)) and transmitting user input based on the pairing-status indicator (para. 0092 (The handheld programmer is thus considered to be in “telecommunicative” contact with the IPG, and the clinician programmer is likewise considered to be in telecommunicative contact with the handheld programmer), 0167 (All devices in the link with the IPG, e.g., the hand held device 202, and clinician programmer 204, and the clinician programmer 204, are synchronized so that each device receives accurate and current data… physician is able to program the stimulator through either the patient programmer 202 or the clinician programmer 204 while linked together through the link 203, with all programming changes being mirrored in both devices)).
Huston, Whitehurst, and Woods are all considered to be analogous to the claimed invention because they are in the same field of applying stimulation to a user. Therefore, it would also have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Huston to incorporate the teachings of Whitehurst listed and provide a mobile phone to transmit the user input to the external programmer, to then be transmitted to the stimulator. Doing so optimizes the system by having a mobile phone, that is easy to carry around, to allow the physician to change parameters that will be transmitted to the stimulator, through the external programmer.
Additionally, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Huston (in view of Whitehurst) to incorporate the teachings of Woods and provide a pairing status indicator from the external programmer, and transmitting the user input from the mobile device to the external programmer for transmission to the implantable microstimulator based on the pairing- status indicator. Doing so ensures a connection between the external programmer and the stimulator, to ensure that the user input from the mobile device is able to be transmitted.
Claims 2-10 and 12 of the reference patent recite the same limitations as claims 3-12 of the instant application.
Claims 13-22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 13-21 and 23 of U.S. Patent No. 12121726 B2 view of Skelton et al. (US 20100280500 A1), hereinafter Skelton, and in further view of Huston et al. (US 20060178703 A1), hereinafter Huston, and Whitehurst et al. (US 20110077721 A1), hereinafter Whitehurst, and Woods et al. (US 20030114899 A1), hereinafter Woods. The claims of the instant application and the claims of the reference patent are compared in the table below.
Instant application
13. A system for treating rheumatoid arthritis, the system comprising: an implantable microstimulator configured to apply neural stimulation to a cholinergic anti-inflammatory pathway (NCAP);an external programmer comprising a charger configured to communicate with the implantable microstimulator and to charge the implantable microstimulator; and a non-transitory computer-readable medium including computer-program instructions, that, when executed by one or more processors of a mobile device, perform a computer-implemented method comprising: receiving, via the mobile device, user input for delaying or cancelling a scheduled dosing delivered by the implantable microstimulator to treat rheumatoid arthritis;
U.S. Patent No. 12121726 B2
13. A system for treating inflammation, the system comprising: an implantable microstimulator configured to apply neural stimulation to a cholinergic anti- inflammatory pathway (NCAP); an external programmer configured to communicate with the implantable microstimulator; and a non-transitory computer-readable medium including computer-program instructions, that, when executed by one or more processors, perform a computer-implemented method comprising: presenting a user interface for adjusting stimulation parameters of the implantable microstimulator;
receiving, via the mobile device, a pairing-status indicator from the charger indicating that the charger is associated with the implantable microstimulator; and transmitting the user input from the mobile device to the charger for transmission to the implantable microstimulator based on the pairing-status indicator.
receiving user input for adjusting or delaying dosing delivered by the implantable microstimulator; confirming that the external programmer is paired with the implantable microstimulator; transmitting the user input indirectly to the implantable microstimulator through the external programmer when the external programmer is paired with the implantable microstimulator; and receiving an emergency stop and directly transmitting the emergency stop to the implantable microstimulator.
14. A method of treating rheumatoid arthritis using an implantable microstimulator, the method comprising: receiving, through the user interface on a user's mobile device, user input for delaying or cancelling a scheduled dosing by the implantable microstimulator for dosing delivered by the implantable microstimulator to treat rheumatoid arthritis, wherein the user input for delaying dosing is received when an external programmer is not in communication with the implantable microstimulator;
14. A method of treating inflammation using an implantable microstimulator configured to apply neural stimulation to a cholinergic anti-inflammatory pathway (NCAP), an external programmer configured to communicate with the implantable microstimulator, and a user's mobile device, the method comprising: presenting a user interface for adjusting stimulation parameters of the implantable microstimulator on the user's mobile device;
receiving, via the mobile device, a pairing-status indicator from the charger indicating that the charger is associated with the implantable microstimulator; and transmitting the user input from the mobile device to the charger for transmission to the implantable microstimulator based on the pairing-status indicator.
receiving, through the user interface, user input for delaying dosing by the implantable microstimulator or adjusting stimulation parameters of the implantable microstimulator for dosing delivered by the implantable microstimulator, wherein the user input for delaying dosing is received when the external programmer is not in communication with the implantable microstimulator; confirming that the external programmer is paired with the implantable microstimulator; transmitting the user input from the user's mobile device indirectly to the implantable microstimulator through the external programmer when the external programmer is paired with the implantable microstimulator; and adjusting the implantable microstimulator based on the user input
15. The method of claim 14, wherein the implantable microstimulator is a leadless implantable microstimulator.
15. The method of claim 14, wherein the implantable microstimulator is a leadless implantable microstimulator.
16. The method of claim 14, wherein the charger comprises an inductive charger.
16. The method of claim 14, wherein the external programmer comprises an inductive charger.
17. The method of claim 14, further comprising receiving data associated with a patient metric and adjusting the dosing based on the patient metric.
17. The method of claim 14, further comprising receiving data associated with a patient metric and adjusting the dosing based on the patient metric.
18. The method of claim 17, wherein the patient metric comprises a biomarker for inflammation
18. The method of claim 17, wherein the patient metric comprises a biomarker for inflammation.
19. The method of claim 17, wherein the biomarker for inflammation comprises a cytokine level and/or a memory T cell level.
19. The method of claim 18, wherein the biomarker for inflammation comprises a cytokine level and/or a memory T cell level.
20. The method of claim 17, wherein the patient metric comprises an activity metric or a physiological metric.
20. The method of claim 17, wherein the patient metric comprises an activity metric or a physiological metric.
21. The method of claim 14, further comprising receiving an emergency stop and transmitting the emergency stop directly to the implantable microstimulator.
21. The method of claim 14, further comprising receiving an emergency stop and transmitting the emergency stop directly to the implantable microstimulator.
22. The method of claim 14, further comprising preventing, by the external programmer, improper modification of dosing
23. The method of claim 14, further comprising preventing, by the external programmer, improper modification of dosing.
Claims 13-14 of the reference patent recites all the limitations of claim 13-14 of the instant application except “an external programmer comprising a charger, treating rheumatoid arthritis, receiving user input, via a mobile device, receiving, via the mobile device, a pairing-status indicator from the charger indicating that the charger is associated with the implantable microstimulator; and transmitting the user input from the mobile device to the charger for transmission to the implantable microstimulator based on the pairing-status indicator”.
However, Skelton teaches an external programmer (Fig. 6, element 20) comprising a charger configured to communicate with the implantable microstimulator para. 0064 (IMD communicates with external programmer)) and to charge the implantable microstimulator (para. 0122 (external inductive power supply), 0131 (external programmer may include a charger module capable of recharging a power source)). It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have the external programmer comprise a charger, as disclosed in Skelton, within the system of claim 13, to allow the implantable stimulator to be charged. Doing so prevents the implantable device from being removed from a patient to replace the battery.
Skelton does not teach treating rheumatoid arthritis, receiving user input, via a mobile device, receiving, via the mobile device, a pairing-status indicator from the charger indicating that the charger is associated with the implantable microstimulator; and transmitting the user input from the mobile device to the charger for transmission to the implantable microstimulator based on the pairing-status indicator.
However, Huston teaches treating rheumatoid arthritis (para. 0066 (condition can be mediated by a localized inflammatory cytokine cascade, as in rheumatoid arthritis)). It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to treat rheumatoid arthritis, as disclosed in Huston, within the system of Skelton, to enable treatment of rheumatoid arthritis by applying neural stimulation to modulate the inflammatory response associated with the disease. Doing so would reduce levels of pro-inflammatory cytokines and expand the therapeutic applicability of Skelton’s system and method.
Huston does not teach an implantable microstimulator, receiving user input, via a mobile device, receiving, via the mobile device, a pairing-status indicator from the charger indicating that the charger is associated with the implantable microstimulator; and transmitting the user input from the mobile device to the charger for transmission to the implantable microstimulator based on the pairing-status indicator.
Whitehurst teaches an implantable microstimulator (para. 001 (implantable microstimulator)) configured to apply stimulation (para. 0065 (stimulation));
receiving, via a mobile device (Fig. 4, element 218 – telephone modem), user input for delaying or cancelling a scheduled dosing delivered by the implantable microstimulator (para. 0106 (external programmer 200 is provided with an interface means 216 for interacting with other computing means 218, such as by a serial interface cable or infrared link to a personal computer or to a telephone modem or the like. Such interface means 216 may permit a clinician to monitor the status of the implant and prescribe new stimulation parameters from a remote location)); and
transmitting the user input from the mobile device to the external programmer for transmission to the implantable microstimulator (para. 0106 (external programmer 200 is provided with an interface means 216 for interacting with other computing means 218, such as by a serial interface cable or infrared link to a personal computer or to a telephone modem or the like. Such interface means 216 may permit a clinician to monitor the status of the implant and prescribe new stimulation parameters from a remote location)).
Whitehurst does not teach receiving, via the user's mobile device, a pairing status indicator from a charger indicating the charger is paired with the implantable microstimulator; and transmitting the user input from the user's mobile device to the charger for transmission to the implantable microstimulator based on the pairing status indicator.
Woods teaches receiving, via an external device (Fig. 1, element 204), a pairing-status indicator (Fig. 7C, element 250 – status icon) from an external programmer (Fig. 1, element 202 – hand held programmer) indicating that the external programmer is paired with an implantable medical device (Fig. 1, element 100, para. 0189 (status icons 250 are provided that display the status of the patient-programmer-to-implant link and the patient-programmer-to-clinician-programmer link), 0164 (a communication link status between devices is always depicted on a screen associated with the programmer 204));
a battery status indicator (para. 0012 (battery status indicator that is located on an external programmer which can be used to upload battery status information from the medical device and convey that information via the status indicator to the patient or clinician)); and
transmitting user input based on the pairing-status indicator (para. 0092 (The handheld programmer is thus considered to be in “telecommunicative” contact with the IPG, and the clinician programmer is likewise considered to be in telecommunicative contact with the handheld programmer), 0167 (All devices in the link with the IPG, e.g., the hand held device 202, and clinician programmer 204, and the clinician programmer 204, are synchronized so that each device receives accurate and current data… physician is able to program the stimulator through either the patient programmer 202 or the clinician programmer 204 while linked together through the link 203, with all programming changes being mirrored in both devices)).
It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Skelton to incorporate the teachings of Whitehurst and provide a microstimulator. Skelton teaches an implantable stimulator device, but does not explicitly disclose a microstimulator. Therefore, incorporating the microstimulator taught by Whitehurst, would allow a minimal surgical procedure by implanting the microstimulator via a small incision, preventing more complicated surgical procedures, thereby reducing tissue trauma.
Skelton teaches receiving user input and transmitting the user input to the external programmer for transmission to the implantable microstimulator (para. 0125, 0129). Whitehurst teaches receiving user input from a mobile device and transmitting it to the external programmer for transmission to the implantable microstimulator (para. 0106). Therefore, it would also have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Skelton to incorporate the teachings of Whitehurst listed and provide a mobile phone transmitting user input to the external programmer that comprises the charger. Doing so optimizes the system by having a mobile phone, that is easy to carry around, to allow the physician to change parameters that will be transmitted to the stimulator, through the external programmer, and establish a connection with the charger of the external programmer.
Woods teaches a clinician programmer that communicates with the implantable medical device through the external programmer, and that the clinician programmer displays a communication status, that ensures that the external system is connected to the implantable system (para. 0164, 0167, 0189). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Skelton (in view of Whitehurst) to incorporate the teachings of Woods and provide a pairing status indicator from the charger, and transmitting the user input from the mobile device to the charger for transmission to the implantable microstimulator based on the pairing- status indicator. Doing so ensures a connection between the charger within the external programmer and the stimulator, to ensure that the user input from the mobile device is able to be transmitted, and ensures that the implantable stimulator is connected to the charger to be recharged.
Claims 15-21 and 23 of the reference patent recite the same limitations as claims 15-22 of the instant application.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claims 2-7, 9-11, 13-18, 20 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Skelton et al. (US 20100280500 A1), hereinafter Skelton, and in view of Huston et al. (US 20060178703 A1), hereinafter Huston, and in further view of Whitehurst et al. (US 20110077721 A1), hereinafter Whitehurst, and Woods et al. (US 20030114899 A1), hereinafter Woods.
Regarding claim 2, Skelton teaches a system (para. 0032 (implantable electrical stimulation system)) the system comprising:
an implantable microstimulator (para. 0004 (implantable stimulator device)) configured to apply neural stimulation (para. 0003 (neurostimulator), 0046 (IMD may be used with… peripheral nerve stimulation));
an external programmer (Fig. 6, element 20) configured to communicate with the implantable microstimulator (para. 0064 (IMD communicates with external programmer)); and
a non-transitory computer-readable medium including computer-program instructions (para. 0009 (computer readable storage medium comprising instructions)), that, when executed by one or more processors (para. 0093 (memory may store instructions for execution by processor)), perform a computer-implemented method (para. 0239 (instructions may be executed)) comprising:
receiving user input (para. 0129 (receive input from a user)) for delaying or cancelling a scheduled dosing delivered by the implantable microstimulator (para. 0231 (receive input from a user defining a new time period, receive a selection of new therapy parameters));
transmitting the user input to the external programmer for transmission to the implantable microstimulator (para. 0125 (external programmer includes telemetry circuit), 0130 (telemetry circuit may communicate with IMD… when the telemetry circuit detects the proximity of stimulator… telemetry circuit may communicate with IMD when signaled by a user through user interface)).
Skelton does not teach a system treating rheumatoid arthritis, a microstimulator, applying neural stimulation to a NCAP, receiving user input from a mobile device, the mobile device receiving a pairing status indicator from the external programmer, and transmitting the user input from the mobile device to the external programmer for transmission to the implantable microstimulator based on the pairing- status indicator.
Huston teaches treating rheumatoid arthritis (abstract (A method and an apparatus for treating a patient suffering from, or at risk for, a condition mediated by the inflammatory cytokine cascade, by electrically stimulating vagus nerve activity in an amount sufficient to inhibit the inflammatory cytokine cascade), para. 0067 (conditions which can be usefully treated include… rheumatoid arthritis)) and apply neural stimulation to a cholinergic anti-inflammatory pathway (NCAP) (0010 (electrical vagus nerve stimulation was sufficient for activation of the cholinergic anti-inflammatory pathway), 0085 (cholinergic anti-inflammatory pathway activation is responsive to… electrical stimulation parameters)).
Huston does not teach receiving user input from a mobile device, the mobile device receiving a pairing status indicator from the external programmer, and transmitting the user input from the mobile device to the external programmer for transmission to the implantable microstimulator based on the pairing- status indicator.
Whitehurst teaches a system (para. 0001 (system)), the system comprising:
an implantable microstimulator (para. 001 (implantable microstimulator)) configured to apply stimulation (para. 0065 (stimulation));
receiving, via a mobile device (Fig. 4, element 218 – telephone modem), user input for delaying or cancelling a scheduled dosing delivered by the implantable microstimulator (para. 0106 (external programmer 200 is provided with an interface means 216 for interacting with other computing means 218, such as by a serial interface cable or infrared link to a personal computer or to a telephone modem or the like. Such interface means 216 may permit a clinician to monitor the status of the implant and prescribe new stimulation parameters from a remote location)); and
transmitting the user input from the mobile device to the external programmer for transmission to the implantable microstimulator (para. 0106 (external programmer 200 is provided with an interface means 216 for interacting with other computing means 218, such as by a serial interface cable or infrared link to a personal computer or to a telephone modem or the like. Such interface means 216 may permit a clinician to monitor the status of the implant and prescribe new stimulation parameters from a remote location)).
Whitehurst does not teach receiving, via the mobile device, a pairing-status indicator from the external programmer indicating that the external programmer is paired with the implantable microstimulator, and transmitting user input based on the pairing- status indicator.
Woods teaches receiving, via an external device (Fig. 1, element 204), a pairing-status indicator (Fig. 7C, element 250 – status icon) from an external programmer (Fig. 1, element 202 – hand held programmer) indicating that the external programmer is paired with an implantable medical device (Fig. 1, element 100, para. 0189 (status icons 250 are provided that display the status of the patient-programmer-to-implant link and the patient-programmer-to-clinician-programmer link), 0164 (a communication link status between devices is always depicted on a screen associated with the programmer 204)) and
transmitting user input based on the pairing-status indicator (para. 0092 (The handheld programmer is thus considered to be in “telecommunicative” contact with the IPG, and the clinician programmer is likewise considered to be in telecommunicative contact with the handheld programmer), 0167 (All devices in the link with the IPG, e.g., the hand held device 202, and clinician programmer 204, and the clinician programmer 204, are synchronized so that each device receives accurate and current data… physician is able to program the stimulator through either the patient programmer 202 or the clinician programmer 204 while linked together through the link 203, with all programming changes being mirrored in both devices)).
Skelton, Huston, Whitehurst, and Woods are all considered to be analogous to the claimed invention because they are in the same field of applying stimulation to a user. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Skelton’s system to incorporate the teachings of Huston and provide a system for treating rheumatoid arthritis and applying neural stimulation to a cholinergic anti-inflammatory pathway. Skeleton teaches a system to treat chronic pain but does not disclose treating rheumatoid arthritis and applying neural stimulation to a cholinergic anti-inflammatory pathway (para. 0039). Huston teaches that applying stimulation to the NCAP, reduces cytokine production (para. 0085). One of ordinary skill in the art would have been motivated to target the NCAP as Huston teaches that the NCAP’s effects are long lasting after stimulation (para. 0087). Therefore, such targeting would improve treatment specificity, providing a more effective therapeutic approach for managing rheumatoid arthritis.
It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Skelton to incorporate the teachings of Whitehurst and provide a microstimulator. Skelton teaches an implantable stimulator device, but does not explicitly disclose a microstimulator. Therefore, incorporating the microstimulator taught by Whitehurst, would allow a minimal surgical procedure by implanting the microstimulator via a small incision, preventing more complicated surgical procedures, thereby reducing tissue trauma.
Skelton teaches receiving user input and transmitting the user input to the external programmer for transmission to the implantable microstimulator (para. 0125, 0129). Whitehurst teaches receiving user input from a mobile device and transmitting it to the external programmer for transmission to the implantable microstimulator (para. 0106). Therefore, it would also have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Skelton to incorporate the teachings of Whitehurst listed and provide a mobile phone to transmit the user input to the external programmer, to then be transmitted to the stimulator. Doing so optimizes the system by having a mobile phone, that is easy to carry around, to allow the physician to change parameters that will be transmitted to the stimulator, through the external programmer.
Woods teaches a clinician programmer that communicates with the implantable medical device through the external programmer, and that the clinician programmer displays a communication status, that ensures that the external system is connected to the implantable system (para. 0164, 0167, 0189). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Skelton (in view of Whitehurst) to incorporate the teachings of Woods and provide a pairing status indicator from the external programmer, and transmitting the user input from the mobile device to the external programmer for transmission to the implantable microstimulator based on the pairing- status indicator. Doing so ensures a connection between the external programmer and the stimulator, to ensure that the user input from the mobile device is able to be transmitted.
Regarding claim 3, Skelton (in view of Huston, Whitehurst, and Woods) teaches the system of claim 2, wherein the implantable microstimulator is a leadless implantable microstimulator (para. 0043 (IMD may be a leadless stimulator).
Regarding claim 4, Skelton (in view of Huston, Whitehurst, and Woods) teaches the system of claim 2, wherein the non-transitory computer-readable medium is configured to execute on the mobile device (para. 0125 (programmer may be a cell phone)).
Regarding claim 5, Skelton (in view of Huston, Whitehurst, and Woods) teaches the system of claim 2, wherein the external programmer comprises a charger (para. 0131 (external programmer may include a charger module capable of recharging a power source)).
Regarding claim 6, Skelton (in view of Huston, Whitehurst, and Woods) teaches the system of claim 2, wherein the computer-implemented method further comprises receiving data associated with a patient metric and adjusting the dosing based on the patient metric (para. 0003 (allow for therapy activation, and/or adjustments to therapy parameters), 0058 (may transmit parameter adjustments to support therapy modification relating to changes in the posture state of patient), 0110 (processor may also adjust therapy for a new posture when posture state module indicates that patient has in fact changes postures… stimulation adjustments in response to posture state may be automatic or semi-automatic), 0226 (IMD receives a therapy adjustment from a programmer to define new therapy parameters)).
Regarding claim 7, Skelton (in view of Huston, Whitehurst, and Woods) teaches the system of claim 6.
Skeleton does not teach wherein the patient metric comprises a biomarker for inflammation.
Huston teaches wherein the patient metric comprises a biomarker for inflammation (Fig. 4, Fig. 5, para. 0051 (proinflammatory cytokine is TNF), 0083 (TNF concentrations)).
It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Skelton to incorporate the teachings of Huston and provide a biomarker for inflammation. Doing so provides a relevant indicator of inflammatory status as pro-inflammatory cytokines are associated with rheumatoid arthritis. Therefore, tracking cytokine levels may allow determination of whether the neural stimulation is effectively suppressing inflammatory signaling.
Regarding claim 9, Skelton (in view of Huston, Whitehurst, and Woods) teaches the system of claim 6, wherein the patient metric comprises an activity metric or a physiological metric (para. 0115 (posture state module may sensor physiological parameters of patient, may include heart rate, respiration rate)), 0109 (posture state module… may correspond to an activity and/or posture undertaken by patient)).
Regarding claim 10, Skelton (in view of Huston, Whitehurst, and Woods) teaches the system of claim 2, further comprising receiving, from the user interface, an emergency stop command and transmitting the emergency stop directly to the implantable microstimulator (para. 0128 (user interface in order to … turn stimulation off)).
Regarding claim 11, Skelton (in view of Huston, Whitehurst, and Woods) teaches the system of claim 2, wherein receiving user input for adjusting or delaying dosing delivered by the implantable microstimulator comprises receiving the user input when the external programmer is not in communication with the implantable microstimulator (para. 0121 (telemetry circuit [within the IMD] may send information to and receive information from external programmer on a continuous basis… or upon request from the stimulator or programmer)).
Regarding claim 13, Skelton teaches a system (para. 0032 (implantable electrical stimulation system)), the system comprising:
an implantable microstimulator (para. 0004 (implantable stimulator device)) configured to apply neural stimulation (para. 0003 (neurostimulator));
an external programmer (Fig. 6, element 20) comprising a charger configured to communicate with the implantable microstimulator para. 0064 (IMD communicates with external programmer)) and to charge the implantable microstimulator (para. 0122 (external inductive power supply), 0131 (external programmer may include a charger module capable of recharging a power source)); and
a non-transitory computer-readable medium including computer-program instructions (para. 0009 (computer readable storage medium comprising instructions)), that, when executed by one or more processors (para. 0093 (memory may store instructions for execution by processor)), perform a computer-implemented method (para. 0239 (instructions may be executed)) comprising:
receiving user input (para. 0129 (receive input from a user)) for adjusting or delaying dosing delivered by the implantable microstimulator (para. 0231 (receive input from a user defining a new time period, receive a selection of new therapy parameters)).
Skelton does not teach a system for treating rheumatoid arthritis, a microstimulator configured to apply neural stimulation to a cholinergic anti-inflammatory pathway (NCAP), one or more processors of a mobile device, receiving, via the mobile device, user input, receiving, via the mobile device, a pairing-status indicator from the charger indicating that the charger is associated with the implantable microstimulator; and
transmitting the user input from the mobile device to the charger for transmission to the implantable microstimulator based on the pairing-status indicator.
Huston teaches treating rheumatoid arthritis (abstract (A method and an apparatus for treating a patient suffering from, or at risk for, a condition mediated by the inflammatory cytokine cascade, by electrically stimulating vagus nerve activity in an amount sufficient to inhibit the inflammatory cytokine cascade), para. 0067 (conditions which can be usefully treated include… rheumatoid arthritis)) and apply neural stimulation to a cholinergic anti-inflammatory pathway (NCAP) (0010 (electrical vagus nerve stimulation was sufficient for activation of the cholinergic anti-inflammatory pathway), 0085 (cholinergic anti-inflammatory pathway activation is responsive to… electrical stimulation parameters)).
Huston does not teach one or more processors of a mobile device, receiving, via the mobile device, user input, receiving, via the mobile device, a pairing-status indicator from the charger indicating that the charger is associated with the implantable microstimulator; and
transmitting the user input from the mobile device to the charger for transmission to the implantable microstimulator based on the pairing-status indicator.
Whitehurst teaches one or more processors of a mobile device (para. 0106 (external programmer 200 is provided with an interface means 216 for interacting with other computing means 218, such as a telephone modem or the like. Such interface means 216 may permit a clinician to monitor the status of the implant and prescribe new stimulation parameters from a remote location));
an implantable microstimulator (para. 001 (implantable microstimulator)) configured to apply stimulation (para. 0065 (stimulation));
receiving, via a mobile device (Fig. 4, element 218 – telephone modem), user input for delaying or cancelling a scheduled dosing delivered by the implantable microstimulator (para. 0106 (external programmer 200 is provided with an interface means 216 for interacting with other computing means 218, such as by a serial interface cable or infrared link to a personal computer or to a telephone modem or the like. Such interface means 216 may permit a clinician to monitor the status of the implant and prescribe new stimulation parameters from a remote location)); and
transmitting the user input from the mobile device to the external programmer for transmission to the implantable microstimulator (para. 0106 (external programmer 200 is provided with an interface means 216 for interacting with other computing means 218, such as by a serial interface cable or infrared link to a personal computer or to a telephone modem or the like. Such interface means 216 may permit a clinician to monitor the status of the implant and prescribe new stimulation parameters from a remote location)).
Whitehurst does not teach receiving, via the mobile device, a pairing-status indicator from the charger indicating that the charger is associated with the implantable microstimulator; and transmitting the user input from the mobile device to the charger for transmission to the implantable microstimulator based on the pairing-status indicator.
Woods teaches receiving, via an external device (Fig. 1, element 204), a pairing-status indicator (Fig. 7C, element 250 – status icon) from an external programmer (Fig. 1, element 202 – hand held programmer) indicating that the external programmer is paired with an implantable medical device (Fig. 1, element 100, para. 0189 (status icons 250 are provided that display the status of the patient-programmer-to-implant link and the patient-programmer-to-clinician-programmer link), 0164 (a communication link status between devices is always depicted on a screen associated with the programmer 204));
a battery status indicator (para. 0012 (battery status indicator that is located on an external programmer which can be used to upload battery status information from the medical device and convey that information via the status indicator to the patient or clinician)); and
transmitting user input based on the pairing-status indicator (para. 0092 (The handheld programmer is thus considered to be in “telecommunicative” contact with the IPG, and the clinician programmer is likewise considered to be in telecommunicative contact with the handheld programmer), 0167 (All devices in the link with the IPG, e.g., the hand held device 202, and clinician programmer 204, and the clinician programmer 204, are synchronized so that each device receives accurate and current data… physician is able to program the stimulator through either the patient programmer 202 or the clinician programmer 204 while linked together through the link 203, with all programming changes being mirrored in both devices)).
It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Skelton’s system to incorporate the teachings of Huston and provide a system for treating rheumatoid arthritis and applying neural stimulation to a cholinergic anti-inflammatory pathway. Skeleton teaches a system to treat chronic pain but does not disclose treating rheumatoid arthritis and applying neural stimulation to a cholinergic anti-inflammatory pathway (para. 0039). Huston teaches that applying stimulation to the NCAP, reduces cytokine production (para. 0085). One of ordinary skill in the art would have been motivated to target the NCAP as Huston teaches that the NCAP’s effects are long lasting after stimulation (para. 0087). Therefore, such targeting would improve treatment specificity, providing a more effective therapeutic approach for managing rheumatoid arthritis.
It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Skelton to incorporate the teachings of Whitehurst and provide a microstimulator. Skelton teaches an implantable stimulator device, but does not explicitly disclose a microstimulator. Therefore, incorporating the microstimulator taught by Whitehurst, would allow a minimal surgical procedure by implanting the microstimulator via a small incision, preventing more complicated surgical procedures, thereby reducing tissue trauma.
Skelton teaches receiving user input and transmitting the user input to the external programmer for transmission to the implantable microstimulator (para. 0125, 0129). Whitehurst teaches receiving user input from a mobile device and transmitting it to the external programmer for transmission to the implantable microstimulator (para. 0106). Therefore, it would also have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Skelton to incorporate the teachings of Whitehurst listed and provide one or more processors of a mobile phone, and the mobile phone transmitting user input to the external programmer that comprises the charger. Doing so optimizes the system by having a mobile phone, that is easy to carry around, to allow the physician to change parameters that will be transmitted to the stimulator, through the external programmer, and establish a connection with the charger of the external programmer.
Woods teaches a clinician programmer that communicates with the implantable medical device through the external programmer, and that the clinician programmer displays a communication status, that ensures that the external system is connected to the implantable system (para. 0164, 0167, 0189). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Skelton (in view of Whitehurst) to incorporate the teachings of Woods and provide a pairing status indicator from the charger, and transmitting the user input from the mobile device to the charger for transmission to the implantable microstimulator based on the pairing- status indicator. Doing so ensures a connection between the charger within the external programmer and the stimulator, to ensure that the user input from the mobile device is able to be transmitted, and ensures that the implantable stimulator is connected to the charger to be recharged.
Regarding claim 14, Skelton teaches a method (para. 0006 (method)) using an implantable stimulator (para. 0004 (implantable stimulator device)), the method comprising:
receiving, through a user interface on a user's mobile device, user input for delaying or cancelling a scheduled dosing by the implantable microstimulator for dosing delivered by the implantable stimulator ((para. 0125 (programmer may be a cell phone), 0129 (receive input from a user), 0231 (receive input from a user defining a new time period, receive a selection of new therapy parameters));
delaying or cancelling the scheduled dose based on the user input (para. 0047 (IMD generates and delivers stimulation therapy according to one or more programs. A program defines values for one or more parameters that define an aspect of the therapy delivered by IMD according to that program), 0064 (IMD communicates with patient programmer to initialize therapy or modify therapy during operation)).
Skelton does not teach a method of treating rheumatoid arthritis, a microstimulator, receiving, via the user's mobile device, a pairing status indicator from a charger indicating the charger is paired with the implantable microstimulator; and transmitting the user input from the user's mobile device to the charger for transmission to the implantable microstimulator based on the pairing status indicator.
Huston teaches a method of treating rheumatoid arthritis (abstract (A method and an apparatus for treating a patient suffering from, or at risk for, a condition mediated by the inflammatory cytokine cascade, by electrically stimulating vagus nerve activity in an amount sufficient to inhibit the inflammatory cytokine cascade)).
Huston does not teach an implantable microstimulator, receiving, via the user's mobile device, a pairing status indicator from a charger indicating the charger is paired with the implantable microstimulator; and transmitting the user input from the user's mobile device to the charger for transmission to the implantable microstimulator based on the pairing status indicator.
Whitehurst teaches an implantable microstimulator (para. 001 (implantable microstimulator)) configured to apply stimulation (para. 0065 (stimulation));
receiving, via a mobile device (Fig. 4, element 218 – telephone modem), user input for delaying or cancelling a scheduled dosing delivered by the implantable microstimulator (para. 0106 (external programmer 200 is provided with an interface means 216 for interacting with other computing means 218, such as by a serial interface cable or infrared link to a personal computer or to a telephone modem or the like. Such interface means 216 may permit a clinician to monitor the status of the implant and prescribe new stimulation parameters from a remote location)); and
transmitting the user input from the mobile device to the external programmer for transmission to the implantable microstimulator (para. 0106 (external programmer 200 is provided with an interface means 216 for interacting with other computing means 218, such as by a serial interface cable or infrared link to a personal computer or to a telephone modem or the like. Such interface means 216 may permit a clinician to monitor the status of the implant and prescribe new stimulation parameters from a remote location)).
Whitehurst does not teach receiving, via the user's mobile device, a pairing status indicator from a charger indicating the charger is paired with the implantable microstimulator; and transmitting the user input from the user's mobile device to the charger for transmission to the implantable microstimulator based on the pairing status indicator.
Woods teaches receiving, via an external device (Fig. 1, element 204), a pairing-status indicator (Fig. 7C, element 250 – status icon) from an external programmer (Fig. 1, element 202 – hand held programmer) indicating that the external programmer is paired with an implantable medical device (Fig. 1, element 100, para. 0189 (status icons 250 are provided that display the status of the patient-programmer-to-implant link and the patient-programmer-to-clinician-programmer link), 0164 (a communication link status between devices is always depicted on a screen associated with the programmer 204));
a battery status indicator (para. 0012 (battery status indicator that is located on an external programmer which can be used to upload battery status information from the medical device and convey that information via the status indicator to the patient or clinician)); and
transmitting user input based on the pairing-status indicator (para. 0092 (The handheld programmer is thus considered to be in “telecommunicative” contact with the IPG, and the clinician programmer is likewise considered to be in telecommunicative contact with the handheld programmer), 0167 (All devices in the link with the IPG, e.g., the hand held device 202, and clinician programmer 204, and the clinician programmer 204, are synchronized so that each device receives accurate and current data… physician is able to program the stimulator through either the patient programmer 202 or the clinician programmer 204 while linked together through the link 203, with all programming changes being mirrored in both devices)).
It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Skelton’s system to incorporate the teachings of Huston and provide a system for treating rheumatoid arthritis and applying neural stimulation to a cholinergic anti-inflammatory pathway. Skeleton teaches a system to treat chronic pain but does not disclose treating rheumatoid arthritis and applying neural stimulation to a cholinergic anti-inflammatory pathway (para. 0039). Huston teaches that applying stimulation to the NCAP, reduces cytokine production (para. 0085). One of ordinary skill in the art would have been motivated to target the NCAP as Huston teaches that the NCAP’s effects are long lasting after stimulation (para. 0087). Therefore, such targeting would improve treatment specificity, providing a more effective therapeutic approach for managing rheumatoid arthritis.
It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Skelton to incorporate the teachings of Whitehurst and provide a microstimulator. Skelton teaches an implantable stimulator device, but does not explicitly disclose a microstimulator. Therefore, incorporating the microstimulator taught by Whitehurst, would allow a minimal surgical procedure by implanting the microstimulator via a small incision, preventing more complicated surgical procedures, thereby reducing tissue trauma.
Skelton teaches receiving user input and transmitting the user input to the external programmer for transmission to the implantable microstimulator (para. 0125, 0129). Whitehurst teaches receiving user input from a mobile device and transmitting it to the external programmer for transmission to the implantable microstimulator (para. 0106). Therefore, it would also have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Skelton to incorporate the teachings of Whitehurst listed and provide a mobile phone transmitting user input to the external programmer that comprises the charger. Doing so optimizes the system by having a mobile phone, that is easy to carry around, to allow the physician to change parameters that will be transmitted to the stimulator, through the external programmer, and establish a connection with the charger of the external programmer.
Woods teaches a clinician programmer that communicates with the implantable medical device through the external programmer, and that the clinician programmer displays a communication status, that ensures that the external system is connected to the implantable system (para. 0164, 0167, 0189). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Skelton (in view of Whitehurst) to incorporate the teachings of Woods and provide a pairing status indicator from the charger, and transmitting the user input from the mobile device to the charger for transmission to the implantable microstimulator based on the pairing- status indicator. Doing so ensures a connection between the charger within the external programmer and the stimulator, to ensure that the user input from the mobile device is able to be transmitted, and ensures that the implantable stimulator is connected to the charger to be recharged.
Regarding claim 15, Skelton (in view of Huston, Whitehurst, and Woods) teaches the method of claim 14, wherein the implantable microstimulator is a leadless implantable microstimulator (para. 0043 (IMD may be a leadless stimulator).
Regarding claim 16, Skelton (in view of Huston, Whitehurst, and Woods) teaches the method of claim 14, wherein the charger comprises an inductive charger (para. 0122 (external inductive power supply), 0131 (external programmer may include a charger module capable of recharging a power source)).
Regarding claim 17, Skelton (in view of Huston, Whitehurst, and Woods) teaches the method of claim 14, further comprising receiving data associated with a patient metric and adjusting the dosing based on the patient metric (para. 0003 (allow for therapy activation, and/or adjustments to therapy parameters), 0058 (may transmit parameter adjustments to support therapy modification relating to changes in the posture state of patient), 0110 (processor may also adjust therapy for a new posture when posture state module indicates that patient has in fact changes postures… stimulation adjustments in response to posture state may be automatic or semi-automatic), 0226 (IMD receives a therapy adjustment from a programmer to define new therapy parameters)).
Regarding claim 18, Skelton (in view of Huston, Whitehurst, and Woods) teaches the method of claim 17.
Skeleton does not teach wherein the patient metric comprises a biomarker for inflammation.
Huston teaches wherein the patient metric comprises a biomarker for inflammation (Fig. 4, Fig. 5, para. 0051 (proinflammatory cytokine is TNF), 0083 (TNF concentrations)).
It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Skelton to incorporate the teachings of Huston and provide a biomarker for inflammation. Doing so would have enabled monitoring of cytokine levels to identify trends that could indicate the effectiveness of the neural stimulation treatment to the user.
Regarding claim 20, Skelton (in view of Huston, Whitehurst, and Woods) teaches the method of claim 17, wherein the patient metric comprises an activity metric or a physiological metric (para. 0115 (posture state module may sensor physiological parameters of patient, may include heart rate, respiration rate)), 0109 (posture state module… may correspond to an activity and/or posture undertaken by patient)).
Regarding claim 21, Skelton (in view of Huston, Whitehurst, and Woods) teaches the method of claim 14, the system further comprising receiving, from the user interface, an emergency stop command and transmitting the emergency stop directly to the implantable microstimulator (para. 0128 (user interface in order to … turn stimulation off)).
Claims 8 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Skelton in view of Huston, and in further view of Whitehurst, Woods, and James et al. (James, E.A., et al. (2014), Citrulline-Specific Th1 Cells Are Increased in Rheumatoid Arthritis and Their Frequency Is Influenced by Disease Duration and Therapy. Arthritis & Rheumatology, 66: 1712-1722, https://doi.org/10.1002/art.38637), hereinafter James.
Regarding claim 8, Skelton (in view of Huston, Whitehurst, and Woods) teaches the system of claim 7.
Skelton does not teach wherein the biomarker for inflammation comprises a cytokine level and/or a memory T cell level.
Huston teaches wherein the biomarker for inflammation comprises a cytokine level (Fig. 4, Fig. 5, para. 0051 (proinflammatory cytokine is TNF), 0083 (TNF concentrations)).
Huston does not teach wherein the biomarker for inflammation comprises a memory T cell level.
James teaches wherein the biomarker for inflammation comprises a memory T cell level (pg. 6 (included memory T cell markers), Fig. 3C).
Skelton, Huston, Whitehurst, Woods, and are all considered to be analogous to the claimed invention because they are in the same field of applying neural stimulation to a user. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Skelton to incorporate the combination of teachings and provide a cytokine level and a memory T cell level. Doing so would have enabled monitoring of cytokine and memory T cell levels to identify trends that could indicate the effectiveness of the neural stimulation treatment to the user.
Regarding claim 19, Skelton (in view of Huston, Whitehurst, and Woods) teaches the method of claim 17.
Skelton does not teach wherein the biomarker for inflammation comprises a cytokine level and/or a memory T cell level.
Huston teaches wherein the biomarker for inflammation comprises a cytokine level (Fig. 4, Fig. 5, para. 0051 (proinflammatory cytokine is TNF), 0083 (TNF concentrations)).
Huston does not teach wherein the biomarker for inflammation comprises a memory T cell level.
James teaches wherein the biomarker for inflammation comprises a memory T cell level (pg. 6 (included memory T cell markers), Fig. 3C).
It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Skelton to incorporate the combination of teachings and provide a cytokine level and a memory T cell level. Doing so would have enabled monitoring of cytokine and memory T cell levels to identify trends that could indicate the effectiveness of the neural stimulation treatment to the user.
Claims 12 and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Skelton in view of Huston, and in further view of Whitehurst, Woods, and Moffitt et al. (US 20160082261 A1), hereinafter Moffitt.
Regarding claim 12, Skelton (in view of Huston, Whitehurst, and Woods) teaches the system of claim 2.
Skelton teaches the external programmer (Fig. 6, element 20).
Skelton does not teach the external programmer preventing improper modification of dosing.
Moffitt teaches wherein the external programmer is configured to prevent improper modification of dosing (para. 0078 (programming control circuit may check values of the plurality of modulation parameters against safety rules to limit these values within constraints of the safety rules), 0072 (delivery of the neuromodulation is controlled by using a plurality of modulation parameters)).
Skelton, Huston, Whitehurst, Woods, and Moffitt are all considered to be analogous to the claimed invention because they are in the same field of applying neural stimulation to a user. It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Skelton’s external programmer to incorporate the teachings of Moffitt to prevent improper modification of dosing. Doing so would provide a safety check to ensure that the patient is modifying the doses within the parameters of the stimulation therapy.
Regarding claim 22, Skelton (in view of Huston, Whitehurst, and Woods) teaches the method of claim 14.
Skelton teaches the external programmer (Fig. 6, element 20).
Skelton does not teach the external programmer preventing improper modification of dosing.
Moffitt teaches wherein the external programmer is configured to prevent improper modification of dosing (para. 0078 (programming control circuit may check values of the plurality of modulation parameters against safety rules to limit these values within constraints of the safety rules), 0072 (delivery of the neuromodulation is controlled by using a plurality of modulation parameters)).
It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Skelton’s external programmer to incorporate the teachings of Moffitt to prevent improper modification of dosing. Doing so would provide a safety check to ensure that the patient is modifying the doses within the parameters of the stimulation therapy.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to EILEEN ROBLES whose telephone number is (571)429-9383. The examiner can normally be reached Monday-Friday: 8:00 - 5:00 PM.
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/EILEEN ROBLES/Examiner, Art Unit 3792
/William J Levicky/Primary Examiner, Art Unit 3796
