DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Arguments
35 USC 101
Applicant’s arguments, see pages 8-15, filed on 11/05/2025, with respect to the 35 USC 101 rejections of claims 1-12 have been fully considered and are persuasive. The 35 USC 101 rejection of claims 1-12 has been withdrawn.
112b
Applicant’s arguments, see pages 15-16, filed on 11/05/2025, with respect to the 35 USC 112(b) rejection of claims 1-11 have been fully considered and are persuasive. The 35 USC 112(b) rejection of claims 1-11 has been withdrawn.
Prior Art Rejections
Applicant’s arguments with respect to claim(s) 1-12 and 16-23 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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, 7-8, 12, 16, and 22-23 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Torgerson (US 2020/0038660).
Regarding claims 1, 12, and 16 Torgerson discloses a system (Fig. 1: system 100) comprising:
electrodes (electrodes of leads 16A, 16B) configured to deliver electrical stimulation to a patient (patient 12; [0032]); and
a device (Fig. 2: IMD 102) comprising electrical stimulation circuitry (Fig. 2: stimulation generator 202) configured to deliver the electrical stimulation to the patient via the electrodes [0062]; and
processing circuitry (Fig. 2: processor 210) configured to:
determine, for a patient, a loading dose (stimulation therapy program) of the electric stimulation ([0101] Processor 210 may control the delivery of electrical stimulation therapy according to one or more electrical stimulation therapy programs),
wherein the loading dose is configured to provide a pain relief therapy ([0101] electrical stimulation therapy programs configured to provide pain relief to patient 12);
cause electrical stimulation circuitry to deliver, during a first time period, the loading dose to the patient (Fig. 5: step 402; [0107]);
receive patient feedback (evoked response) representing a response of the patient to pain relief provided by the loading dose ([0109] Processor 210 determines that the electrical stimulation therapy evokes a compound action potential in the target tissue of patient 112 (504));
determine, based on patient feedback, a maintenance dose (adjusted therapy) of electrical stimulation, wherein the maintenance dose is configured to maintain the pain relief therapy ([0110] processor 210 adjusts one or more parameters defining the stimulation therapy to eliminate the evoked compound action potentials in the tissue of the patient (506)); and
cause the electrical stimulation circuitry to deliver, and during a second time period that is after the first time period (subsequent delivery), a maintenance dose of the electrical stimulation ([0110] subsequent delivery of the electrical stimulation),
wherein delivering the maintenance dose of electrical stimulation consumes less power than delivering the loading dose of electrical stimulation ([0110] processor 210 reduces the magnitude of the one or more parameters defining the electrical stimulation therapy program (e.g., a current amplitude, a voltage amplitude, a frequency, a pulse width, etc.)).
Regarding claims 7 and 22, Torgerson discloses wherein the patient feedback comprises one or more of: an evoked compound action potential, a local field potential, a heart rate, a heart rate variability, a blood flow, a galvanic skin response, a network excitability, a pain response, pain score, an area of pain, an amount of paresthesia, an area of paresthesia, a voiding rate, a patient position, a patient movement, a patient movement history over a predetermined amount of time, and a history of patent-selected stimulation parameters over a predetermined amount of time ([0109] processor 210 determines that the electrical stimulation therapy evokes a compound action potential (504)).
Regarding claims 8 and 23, Torgerson discloses wherein at least one of: an amplitude of the maintenance dose is less than an amplitude of the loading dose, a pulse width of the maintenance dose is less than a pulse width of the loading dose, a pulse frequency of the maintenance dose is less than a pulse frequency of the loading dose, a cycling frequency of the maintenance dose is less than a cycling frequency of the loading dose, an amount of off-time of the maintenance dose is greater than an amount of off-time of the loading dose, or an amount of on-time of the maintenance dose is less than an amount of on-time of the loading dose ([0110] processor 210 reduces the magnitude of the one or more parameters defining the electrical stimulation therapy program (e.g., a current amplitude, a voltage amplitude, a frequency, a pulse width, etc.)).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 2, 5, 17, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Torgerson (US 2020/0038660) in view of Pivonka et al (US 2018/0256906) hereinafter Pivonka.
Regarding claims 2 and 17, Torgerson discloses wherein causing the electrical stimulation circuitry to deliver the loading dose comprises causing first electrical stimulation circuitry of a first stimulator device to deliver the loading dose, the first stimulator device is configured to deliver pain relief therapy, but fails to disclose wherein causing the electrical stimulation circuitry to deliver the maintenance dose comprises causing second electrical stimulation circuitry of a second stimulator device that is implantable in the patient, to deliver the maintenance dose,
the first stimulator device is different than the second stimulator device, and
the first stimulator device and the second stimulator device are configured to deliver pain relief therapy.
However, Pivonka discloses causing second electrical stimulation circuitry of a second stimulator device (implantable devices 200) that is implantable in the patient, to deliver the maintenance dose ([0504] each implantable device can be configured to deliver energy),
the first stimulator device is different than the second stimulator device ([0504] one or more implantable devices 200), and
the first stimulator device and the second stimulator device are configured to deliver pain relief therapy ([0464] Apparatus 10 (containing implantable devices 200 as shown in Fig. 2) can be configured to treat pain).
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/method as taught by Torgerson with causing second electrical stimulation circuitry of a second stimulator device that is implantable in the patient, to deliver the maintenance dose, the first stimulator device is different than the second stimulator device, and the first stimulator device and the second stimulator device are configured to deliver pain relief therapy as taught by Pivonka. Such a modification would provide the predictable results of providing one or more implantable devices designed for simplicity of implantation and use, as well as enhanced flexibility and capability in treating patients and/or recording patient data (Pivonka, [0006]).
Regarding claims 5 and 20, The modified Torgerson discloses the system/method of claims 2 and 17 as discussed above, but fails to disclose wherein the first stimulator device is configured to deliver the loading dose via at least one electrode included with a first lead, wherein the second stimulator device is configured to deliver the maintenance dose via at least one electrode included with a second lead.
However, Pivonka discloses wherein the first stimulator device (Fig. 2: implantable device 200a) is configured to deliver the loading dose via at least one electrode included with a first lead ([0509] Each implantable device 200 can comprise one or more leads 265),
wherein the second stimulator device is configured to deliver the maintenance dose via at least one electrode included with a second lead ([0509] Each implantable device 200 can comprise one or more leads 265).
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/method as taught by Torgerson with wherein the first stimulator device is configured to deliver the loading dose via at least one electrode included with a first lead, wherein the second stimulator device is configured to deliver the maintenance dose via at least one electrode included with a second lead as taught by Pivonka. Such a modification would provide the predictable results of providing one or more implantable devices designed for simplicity of implantation and use, as well as enhanced flexibility and capability in treating patients and/or recording patient data (Pivonka, [0006]).
Claim(s) 3-4, 6, 18-19, and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Torgerson (US 2020/0038660) in view of Pivonka (US 2018/0256906) and further in view of Baynham (US 2020/0289822).
Regarding claims 3 and 18, the modified Torgerson discloses the system/method of claims 2 and 17 as discussed above, but fails to disclose wherein the second stimulator device is not independently capable of delivering the loading dose. However, Baynham discloses wherein the second stimulator device is not independently capable of delivering the loading dose ([0026] signal generator 101 can transmit signals (e.g., electrical signals) to the signal delivery elements 110 that excite and/or suppress target nerves (e.g., sympathetic nerves)).
It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to further modify the system/method as taught by Torgerson with the second stimulator device not being independently capable of delivering the loading dose as taught by Baynham. Such a modification would provide the predictable results of delivering therapies for treating pain (Baynham, [0074]).
Regarding claims 4 and 19, the modified Torgerson discloses the system/method of claims 3 and 18 as discussed above, but fails to disclose wherein causing the electrical stimulation circuitry to deliver the loading dose comprises causing the electrical stimulation circuitry to deliver the loading dose by the second stimulator device when the second stimulator device is connected to an external power source.
However, Baynham discloses wherein causing the electrical stimulation circuitry to deliver the loading dose comprises causing the electrical stimulation circuitry to deliver the loading dose by the second stimulator device when the second stimulator device is connected to an external power source ([0028] the external power source 103 can bypass an implanted signal generator and generate a therapy signal directly at the signal delivery devices 110). It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to further modify the system/method as taught by Torgerson with causing the electrical stimulation circuitry to deliver the loading dose by the second stimulator device when the second stimulator device is connected to an external power source as taught by Baynham. Such a modification would provide the predictable results of delivering therapies for treating pain (Baynham, [0074]).
Regarding claims 6 and 21, Torgerson discloses wherein the processing circuitry is further configured to:
receive patient feedback (evoked response) representing a response of the patient to the maintenance dose ([0109] Processor 210 determines that the electrical stimulation therapy evokes a compound action potential in the target tissue of patient 112 (504));
and based on the patient feedback (Fig. 6: step 608), cause the second electrical stimulation circuitry to deliver a rescue dose of electrical stimulation during a third time period that is after the second time period ([0117] IMD 102 slightly increases the magnitude of the electrical stimulation therapy program (612)),
wherein delivering the rescue dose of electrical stimulation consumes more power than delivering the maintenance dose of electrical stimulation (Fig. 6: increase stimulation amplitude 612; Examiner notes that increasing the amplitude would require more power than the previously delivered maintenance dose delivered at step 606).
Torgerson fails to disclose wherein the processing circuitry is configured to: deliver a rescue dose of electrical stimulation while the second stimulator device is connected to an external power source. However, Baynham discloses delivering a rescue dose of electrical stimulation while the second stimulator device is connected to an external power source ([0028] the external power source 103 can bypass an implanted signal generator and generate a therapy signal directly at the signal delivery devices 110). It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to further modify the system/method as taught by Torgerson with delivering a rescue dose of electrical stimulation while the second stimulator device is connected to an external power source as taught by Baynham. Such a modification would provide the predictable results of providing stimulation using a rechargeable external power source to avoid draining the internal battery.
Claim(s) 9-11 are rejected under 35 U.S.C. 103 as being unpatentable over Torgerson (US 2020/0038660) in view of Thacker et al (US 2013/0066411) hereinafter Thacker.
Regarding claim 9, Torgerson discloses wherein causing the electrical stimulation circuitry to deliver the loading dose comprises causing the electrical stimulation circuitry to deliver the loading dose according to a first cycling ([0107] processor 210 controls stimulation generator 202 to deliver electrical stimulation therapy according to one or more electrical stimulation therapy programs; Examiner notes the stimulation therapy program would necessarily have to have a first cycling), but fails to disclose:
wherein causing the electrical stimulation circuitry to deliver the maintenance dosing comprises causing the electrical stimulation circuitry to deliver the maintenance doses according to a second cycling,
wherein a cycling frequency of the second cycling is less than a cycling frequency of the first cycling.
However, Thacker discloses wherein causing the electrical stimulation circuitry to deliver the maintenance dosing comprises causing the electrical stimulation circuitry to deliver the maintenance doses according to a second cycling ([0067] duty cycle may be reduced),
wherein a cycling frequency of the second cycling is less than a cycling frequency of the first cycling ([0067] duty cycle may be reduced). 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 Torgerson with wherein causing the electrical stimulation circuitry to deliver the maintenance dosing comprises causing the electrical stimulation circuitry to deliver the maintenance doses according to a second cycling, wherein a cycling frequency of the second cycling is less than a cycling frequency of the first cycling as taught by Thacker. Such a modification would provide the predictable results of a net power savings (Thacker, [0067]).
Regarding claim 10, Torgerson discloses wherein an amount of on-time of each cycle of the second cycling is less than an amount of on-time of each cycle of the first cycling ([0110] processor 210 reduces the magnitude of the one or more parameters defining the electrical stimulation therapy program (e.g., a current amplitude, a voltage amplitude, a frequency, a pulse width, etc.)).
Regarding claim 11, Torgerson discloses wherein an amount of off-time of each cycle of the second cycling is more than an amount of off-time of each cycle of the first cycling ([0110] processor 210 reduces the magnitude of the one or more parameters defining the electrical stimulation therapy program (e.g., a current amplitude, a voltage amplitude, a frequency, a pulse width, etc.); Examiner notes that if the pulse width is decreased in the second cycling (maintenance dose duty cycle) then the amount of off time would necessarily be more than the amount of off time of each cycle of the first cycling).
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 WILLOW GRACE WELCH whose telephone number is (703)756-1596. The examiner can normally be reached Usually M-F 8:00am - 4:00pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Benjamin Klein can be reached at 571-270-5213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/WILLOW GRACE WELCH/Examiner, Art Unit 3792
/Benjamin J Klein/Supervisory Patent Examiner, Art Unit 3792
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