DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 07/21/2026 has been entered.
Response to Arguments
Applicant’s arguments filed 07/21/2026 have been fully considered but are not persuasive or are moot in view of new grounds of rejection.
Applicant argues, “The Office Action relies on Linden paragraphs [0302], [0204], [0202], [0298], and [0226] for the claimed "post measurement feedback circuit" and the claimed measurement of "real-time stimulation parameters on the stimulation electrode." Those passages do not disclose the amended claim language. Linden paragraphs [0302] and [0204] describe recording or measuring patient parameters, including patient physiologic parameters, and broadly mention closed-loop sensing. But those disclosures do not directly and unambiguously disclose "a post measurement feedback circuit for measuring real-time stimulation parameters on the stimulation electrode," much less real-time stimulation parameters "comprising parameters of the stimulation pulse sequences applied to the stimulation electrode." Similarly, Linden paragraph [0298] refers to analyzing data recorded by stimulation element 260 to assess power transfer, and paragraph [0226] describes adjusting transmitted power. Those disclosures concern power-transfer assessment or external transmitter power adjustment, not measurement of the particular real-time stimulation parameters recited in amended claim 1.”
Examiner respectfully disagrees. Linden discloses that adjustments to power transfer can be made in real-time [0043] and that fast real-time integer computations may be made [0567], and can be made once per stimulation period [0569], which may include multiple stimulation pulses [0061]. Additionally, Linden teaches that energy delivered may be controlled by controlling the stimulation parameters [0276], and that data received by the external system 50 includes stimulation parameter data [0227], which includes one or more parameters of a stimulation waveform [0182].
Further, Linden teaches that programmer 600 monitors power transfer in real time [0233], and that data recorded by 260 can be used to assess power transfer [0298], which can be controlled by adjusting stimulation parameters [0226] transmitted by the implantable device 200 [0226].
Applicant argues, “The Office Action also relies on Linden paragraphs [0320], [0248], [0398], and [0452]- [0453] for the limitation that the main control CPU "periodically sends the real-time stimulation parameters to the extracorporeal energy controller." These disclosures also fall short. Paragraph [0320] broadly states that an implantable device may transmit data, including examples such as stimulation information, patient physiologic information, patient environment information, and device performance or configuration information. Paragraph [0248] discusses synchronization or coordination between implantable and external devices. Paragraph [0398] concerns setting or adjusting stimulation waveform frequency or other stimulation parameters based on a sensor signal. Paragraphs [0452]-[0453] discuss impedance and ECAP monitoring.”
Examiner respectfully disagrees. As stated above, Linden discloses that the apparatus can make adjustments to power transfer in real-time [0043], including adjustments to “power transmission amplitude, duty cycle, frequency, phase, and periodicity” [0233], and that real-time power transfer properties adjustments [0508] occur from a communication link between external device 500 and implantable device 200 [0508], which would require the implantable device periodically sends the real-time stimulation parameters to the extracorporeal energy controller, since functional elements 560 records data associated with stimulation delivered by the implantable device 200 [0243], so that energy delivered may be controlled by controlling the stimulation parameters [0276].
Applicant argues, “Linden also separately describes a different communication approach. In paragraph [0451], Linden states that, "to avoid collisions with data transmitted from the external system 50”.
Examiner respectfully disagrees. Linden discloses that the implantable system 20 can be configured to transmit only upon request after data transmissions from the external system 50 [0451], but does not prevent real-time data transmissions from the implantable system 20 before data transmissions from the external system 50. In other words, as disclosed above, the implantable system 20 is still able to measure real-time stimulation parameters on the stimulation electrode Linden: ([0227]: data received by the external system 50 includes stimulation parameter data, which includes one or more parameters of a stimulation waveform [0182]; [0298]: data recorded by 260 can be used to assess power transfer; [0226]: power transfer adjusted by adjusting duty cycling parameters).
Applicant argues, “Amended claim 1 further requires that "the extracorporeal energy controller comprises a storage unit comprising a memory configured to store the real-time stimulation parameters received from the implantable neurostimulator." Applicant does not dispute that Linden discloses memory in an external controller. But the mere presence of memory is not enough. The claim requires storage of the claimed "real-time stimulation parameters received from the implantable neurostimulator." For the reasons discussed above, Linden does not disclose that the implantable neurostimulator measures and periodically sends those claimed real-time stimulation parameters in the first place.”
Examiner respectfully disagrees. Linden discloses that external system 50 can comprise external programmer 600 [0192], and that 600 monitors power transfer in real time [0233], and that data transfer between implant system 20 and external system 50 includes power transfer efficiency data [0225]. Therefore, to monitor power transfer in real time, the extracorporeal energy controller must comprises a storage unit comprising a memory configured to store the real-time stimulation parameters received from the implantable neurostimulation, as also discussed further below.
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)(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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-11 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Linden et al. (US 2020/0306528).
In re claim 1, Linden discloses an implantable [0007] nerve stimulator system (10),
comprising an implantable neurostimulator (fig. 1: 20) having
a stimulator ([0206]: transmits power; [0189]: power used to deliver stimulation) antenna module (240) and
an extracorporeal energy controller (fig. 1: external system 50 including 50 and 600 [0192]) having an energy controller antenna module (540),
through the stimulator antenna module and the energy controller antenna module [0222], the implantable neurostimulator communicating with and receiving electrical energy from the extracorporeal energy controller ([0184]: implantable device delivers stimulation energy via energy receives wirelessly from external devices; [0270]: power signal may be adjusted by adjusting 540 and 240; [0239, 0244]) through radio frequency ([0256]: housing 210 receives radiofrequency signals; [0177]: data signal which comprises radiofrequency signal includes both power and data; [0059]),
wherein the implantable neurostimulator has
a main control CPU (250),
a main control memory (0282]: 250 comprises a memory register) for storing control information containing clinical stimulation parameters ([0405]: implantable device 200 delivers stimulation by varying stimulation parameters systematically and therefore they must be stored), and
a stimulation electrodes (260; [0325]: stimulation elements 260 comprise electrodes), and
the main control CPU
uses the clinical stimulation parameters to actively generate stimulation pulse sequences ([0276]: plurality of electrodes would provide stimulation pulse sequences; [0355]) and
applies the stimulation pulse sequences to the stimulation electrodes [0276]
wherein the implantable neurostimulator further comprises a post measurement feedback circuit ([0302]: 260 records patient parameters to adjust stimulation; [0204]: various closed loop sensing configurations may be used between implantable device 200 and external device 500) for measuring real-time stimulation parameters on the stimulation electrode
([0302]: 260 i.e. the stimulation electrode records patient parameters; [0227]: data received by the external system 50 includes stimulation parameter data, which includes one or more parameters of a stimulation waveform [0182]; [0233]: programmer 600 monitors power transfer in real time; [0298]: data recorded by 260 can be used to assess power transfer; [0226]: power transfer adjusted by adjusting duty cycling parameters),
the real-time stimulation parameters comprising parameters of the stimulation pulse sequences applied to the stimulation electrode
([0043]: adjustments to power transfer can be made in real-time; [0567-0569]: fast real-time integer computations may be made and can be made once per stimulation period, which may include multiple stimulation pulses [0061]. [0276]: energy delivered may be controlled by controlling the stimulation parameters; [0227]: data received by the external system 50 includes stimulation parameter data, which includes one or more parameters of a stimulation waveform [0182]),
which are transmitted to the main control CPU ([0274-026]: controller 250 controls 260 by receiving sensor data; [0302]: patient parameters used to adjust therapy),
which stores the real-time stimulation parameters in the main control memory ([0202]: stimulation parameters must be stored so they can be used to provide automatic adjustments; [0203-0204, 0398]) and
periodically sends the real-time stimulation parameters to the extracorporeal energy controller
([0320]: implantable device 200 transmits data such as stimulation information to external device 500; [0248]: data recording of 200 happens sequentially and involves coordination with 500; [0398]: external device used to automatically adjust stimulation waveform parameter and therefore must receive the real-time stimulation parameters; [0452-0453]: functional element 560 may automatically adjust therapeutic parameters by monitoring ECAP which can be used to continuously modify stimulation parameters and therefore real-time stimulation parameters must be sent periodically);
the extracorporeal energy controller comprises a storage unit [0449] comprising a memory (fig. 16: 558; [0449]) configured to store the real-time stimulation parameters received from the implantable neurostimulator ([0192]: external system 50 can comprise external programmer 600; [0233]: 600 monitors power transfer in real time; [0225]: data transfer between implant system 20 and external system 50 includes power transfer efficiency data, therefore, the extracorporeal energy controller must comprise a memory to store the real-time stimulation parameters from the implantable neurostimulator; [0398, 0452]).
In re claim 2, Linden discloses wherein
the implantable neurostimulator further comprises
a rectification energy storage circuit (fig. 2: combination of 232 and 270) for storing the received electrical energy ([0552]: rectifier receives energy; [0287, 0553]) and
a front measurement feedback circuit ([0553]: optimization algorithm of arrangement 11 measures stored energy; [0551]: 11 adapts so power delivery from 500 to 200 remains safe and reliable; [0550]: 11 may be performed by external device 500 and implantable device 200) for measuring the electrical energy storage amount in the rectification energy storage circuit [0553], and
when the electrical energy storage amount is insufficient ([0551-0552]: there is a limited energy storage capacity therefore an increase in power consumption that causes insufficient electrical energy storage amount would result in an adjustment), the main control CPU sends a power adjustment instruction to the extracorporeal energy controller which adjusts transmission power based on the received power adjustment instruction ([0550-0551]: arrangement 11 adapts to adjust power delivery from external device 500, and arrangement 11 may be in both the implantable device and the external device; [0043]).
In re claim 3, Linden discloses
wherein the main control CPU sends the real-time stimulation parameters to the extracorporeal energy controller in response to a data read instruction from the extracorporeal energy controller
([0451]: to avoid collisions with external system 50, implantable system 20 may only transmit upon request at specific timings from external system 50; [0248]: coordinated communication between implantable device 200 and external device 500 which means data read instruction must be sent from the external device 500 to receive data; [0398, 0452]);
the storage unit of the extracorporeal energy controller stores the real-time stimulation parameters received from the implantable neurostimulator [0398, 0452]).
In re claim 4, Linden discloses wherein
the extracorporeal energy controller further comprises
an input device (580),
a display device [0230] and
a power supply (570);
the input device and the display device are used to achieve human-machine interaction [0230], so as to send the control information to the implantable neurostimulator ([0230]: user interface used to allow patient or user adjust one or more parameters; [0452]: external device 500 may manually input a change in patient position which adjusts therapeutic parameters; [0251]);
the control information comprises an instruction for modifying the clinical stimulation parameters ([0452]: adjusting therapeutic parameters changes stimulation level and/or therapeutic program; [0230]).
In re claim 5, Linden discloses wherein the control information further comprises an up/down shift instruction ([0231-0232]: external device 500 includes user interface 680 which may adjust stimulation parameters and must be either increase or decrease the parameter; [0456]) to adjust stimulation intensity ([0182]: stimulation parameters include amplitude of voltage and/or current) of the stimulation pulse sequences as needed ([0355]: repeated stimulation periods; [0232, 0452]).
In re claim 6, Linden discloses wherein
the extracorporeal energy controller further comprises the storage unit [0449] that stores
operating program of the extracorporeal energy controller [0449],
information coming from the input device ([0230]: inherent that the input device information would be saved so that the input can be sent over to apparatus 10), and
data received from the implantable neurostimulator ([0451]: data from implantable device must be stored);
the control information also comprises the data read instruction to read operation data comprising real-time stimulation parameters from the implantable neurostimulator at any time ([0508]: adjustments to power transfer properties can be made in real-time; [0553-0554]: feedback loop of arrangement 11 to raise duty cycle in response to disturbance of power, which varies power transfer; [0182]: duty cycle parameter and amount of energy/power are considered stimulation parameters).
In re claim 7, Linden discloses wherein
the implantable nerve stimulator system further comprises an upper computer (600) serving as
a control [0231] and
information processing station [0232], and
the extracorporeal energy controller further comprises an upper computer communication module ([0231]: portion of external device 500 which communicates with programmer 600), through which the upper computer communicates with the extracorporeal energy controller [0231], thereby
sending an instruction to the implantable neurostimulator through the extracorporeal energy controller (optional), or
reads data from the extracorporeal energy controller [0231-0232],
wherein the upper computer communication module is a wireless communication interface ([0228]: Bluetooth would be a wireless communication interface; [0236]).
In re claim 8, Linden discloses wherein the upper computer communication module is a wireless communication module [0228, 0236].
In re claim 9, Linden discloses wherein
the upper computer has an upper computer software ([0192]: inherent that external programmer would have software), through which a user sends an instruction to the extracorporeal controller of a neural stimulation system [0192] to
operate the extracorporeal controller of the neural stimulation system [0192], or
operate the implantable neurostimulator through the extracorporeal controller of the neural stimulation system (optional),
the operations comprising
setting ([0232]: sets stimulation parameters),
measuring ([0232]: receives information),
programming [0232] and
data management ([0232]: receives information from implantable devices that are used to adapt parameters)
of the clinical stimulation parameters [0232-0233],
the clinical stimulation parameters involved in the data management comprising
measurable relevant parameters [0232-0233],
modified data ([0232-0233]: information received is used to modify configuration parameters) and
observation variables ([0232-0233]: confirms adequate power transmission and if parameters need to be adjusted), and
the relevant parameters being generated during operation of
the extracorporeal controller [0232-0233] and
the implantable neurostimulator of the neural stimulation system [0232-0233].
In re claim 10, Linden discloses wherein the upper computer software is capable of operating the upper computer to connect to a network or an internal server ([0228]: programmer 600 and external device can communicate via the internet; [0235]: external programmer must be connected to a network or an internal server to adjust stimulation signal parameters) for
backup ([0231]: programmer 600 can receive commands from external devices 500; [0235-0236]: external programmer 600 receives data and adjusts stimulation parameters which requires program and data to be stored; [0398]) and
update [0398]
of the clinical stimulation parameters
program ([0398]: programmer 600 may update clinical stimulation parameters of the implantable device for automatic adjustment of paraments; [0232]: may update data recording parameter; [0235]).
In re claim 11, Linden discloses
wherein the extracorporeal energy controller further comprises the storage unit that stores
operating program of the extracorporeal energy controller [0449],
information coming from the input device ([0449]: memory of controller 550 would store input from user interface; [0450]), and
data received from the implantable neurostimulator ([0449]: controller 550 would include memory to hold data received from components of apparatus 10);
the control information also comprises the data read instruction to read operation data comprising real-time stimulation parameters from the implantable neurostimulator at any time ([0449]: controller 550 would include a memory that accesses the transmitted data from the implantable device 200 at any time).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant’s disclosure:
Foutz et al. (US 2013/0338732) discloses an apparatus and method for providing efficient stimulation (abstract), wherein pulse generator voltage is adjusted in real time [0051] in response to a current feedback measurement [0051].
Contact
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RUMAISA R BAIG whose telephone number is (571)270-0175. The examiner can normally be reached Mon-Fri: 8am- 5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David Hamaoui can be reached at (571) 270-5625. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/RUMAISA RASHID BAIG/Examiner, Art Unit 3796
/DAVID HAMAOUI/SPE, Art Unit 3796
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