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
Applicant’s arguments filed 01/21/2026 have been fully considered but are not persuasive or are moot in view of new grounds of rejection.
Applicant argues, “Linden does not disclose "measuring real-time stimulation parameters on the stimulation electrode…."the real-time stimulation parameters are periodically sent to the extracorporeal energy controller…..”…"the extracorporeal energy controller comprises a storage unit configured to store the real-time stimulation parameters received from the implantable neurostimulator."
Examiner respectfully disagrees. Linden teaches
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; [0202]: 260 measures stimulation parameters such as heart or spine parameters; [0204]: closed loop sensing provided for sensing parameters which would provide real-time measurement of stimulation parameters; [0298]: data recorded by 260 can be used to assess power transfer; [0226]: power transfer adjusted by adjusting duty cycling parameters),
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 such as heart rate parameter 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 [0398, 0452].
Claim Rejections - 35 USC § 112
Claim 8 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 8 contains the trademark/trade name “Bluetooth”. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe “the upper computer communication module” and, accordingly, the identification/description is indefinite.
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 (fig. 1: 500 is part of external system 50) energy controller (500) 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; [0202]: 260 measures stimulation parameters such as heart or spine parameters; [0204]: closed loop sensing provided for sensing parameters which would provide real-time measurement of stimulation parameters; [0298]: data recorded by 260 can be used to assess power transfer; [0226]: power transfer adjusted by adjusting duty cycling parameters),
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 such as heart rate parameter 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 [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 Bluetooth [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
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.
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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