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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 4/1/2026 has been entered.
Amendment
This action is in response to the Amendment filed on 4/1/2026.
Claims 1-10 and 12-27 are pending.
Response to Arguments
Applicant's arguments filed 4/1/2026 have been fully considered but they are not persuasive.
Rejections under 35 U.S.C. § 103 -U.S. Patent Application Publication No. 2008/0092911 ("Schulman"), U.S. Patent No. 6,978,181 ("Snell") U.S. Patent Application Publication No. 2019/0358454 ("Lin"),
Independent claims 1, 9 and 17 have been amended to now recite
“at least one connection managing module configured and arranged to:
determine whether there exists a unidirectional data transfer from the second computing device to the third computing device, or a unidirectional data transfer from the third computing device to the second
computing device; and
based on the determination that there exists a unidirectional data transfer from the second computing device to the third computing device or a unidirectional data transfer from the third computing device to the second
computing device, block connection and/or data transfer between:
the first computing device and the second computing device, or the first computing device and the third computing device.”
Applicant states that support for these amendments can be found in the original application at, for example, [0042] - [0044] and argues that the prior art fails to teach the claims as recited.
Upon review of the amendments and the originally filed specifications the examiner respectfully disagrees for the following reasons.
Paragraphs [0042]-[0044] have been reproduced below.
[0042] Alternatively, or additionally, the connection between at least one of the implanted pulse generator 12, the controller 14, the first user input terminal 18, or the second user input terminal 16 and the connection managing module 20 can be enabled by at least one of a telemetry module, Bluetooth module, or communication module. In such embodiments, the connection managing module 20 may allow only unidirectional connection or unidirectional data transfer between the controller 14 and the first user input terminal 18, the controller 14 and the second user input terminal 16, or the first user input terminal 18 and the second user input terminal 16.
[0043] The connection managing module can block bidirectional connection or data transfer between the controller 14 and the first user input terminal 18, the controller 14 and the second user input terminal 16, or the first user input terminal 18 and the second user input terminal 16.
[0044] Further, in such embodiments, the connection managing module 20 can either provide 1) connection or data transfer between the controller 14 and the first user input terminal 18 or between the controller 14 and the second user input terminal 16, or 2) connection or data transfer between the first user input terminal 18 and the second user input terminal 16. The connection managing module 20 may only provide connection or data transfer between the controller 14 and the first user input terminal 18 or the controller 14 and the second user input terminal 16 when there is no connection or data transfer between the first user input terminal 18 and the second user input terminal 16. The connection managing module 20 may block connection or data transfer between the controller 14 and the first user input terminal 18 or the controller 14 and the second user input terminal 16 when there exists a connection or data transfer between the first user input terminal 18 and the second user input terminal 16.
In these paragraphs (and in the rest of the originally filed specifications) the connection managing module (which may be embodied as a software module in any of the first, second or third computing devices) does not recite any specific step of actually positively “determining whether there is a unidirectional data transfer” between the second and third computing device or the third and second computing device. It just states that the connection managing module may only provide connection or data transfer between when there is no connection or data transfer first and third devices. There is no written description of “determining whether a unidirectional data transfer exists” as claimed.
Snell teaches “blocking” connection and/or data transfer by preventing interference between devices by having a programmer select and reserve a channel to communicate with a target device and then the programmer communicates the selection of that channel with the other programmers to minimize or avoid communication until the operation is performed by the current programmer. The programmer informs other programmers to stop communicating temporarily (e.g. 512 Fig. 5 col. 8 line 6-10) to ensure that transmission of programming parameters over the channel is free from any interference (e.g. Fig. 5, Col. 7 line 27). They also teach informing other programmers of an impending operation, so then the other programmers temporarily avoid communication on that channel and “perhaps any communication on any channel” (e.g. Col. 8 lines17-22). Thus they clearly teach blocking connection and/or data transfer between the other programmers and the target device on that channel while it is communicating with the target device. As best understood, the determination that there is a unidirectional transfer between a pair of devices is made based on the alert sent to the other devices that they should stop communicating temporarily and the alert sent to the other programmers of an impending operation. That is the device determines that it wants to communicate with another device and informs the other device that it is about to transfer data or receive data and the other device stops communication with the two devices thus interference is prevented during unidirectional communication. Therefore, as best understood Schuler in view of Snell teaches the independent claims with the newly added limitations as recited.
Therefore, the rejection in maintained.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-10 and 12-17 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Independent claims 1, 9 and 17 have been amended to now recite
“at least one connection managing module configured and arranged to:
determine whether there exists a unidirectional data transfer from the second computing device to the third computing device, or a unidirectional data transfer from the third computing device to the second computing device; and
based on the determination that there exists a unidirectional data transfer from the second computing device to the third computing device or a unidirectional data transfer from the third computing device to the second computing device, block connection and/or data transfer between: the first computing device and the second computing device, or the first computing device and the third computing device.”
Upon review of the amendments and the originally filed specifications, there is no support for the connection managing module determining whether a unidirectional data transfer exists.
Paragraphs [0042]-[0044] have been reproduced below.
[0042] Alternatively, or additionally, the connection between at least one of the implanted pulse generator 12, the controller 14, the first user input terminal 18, or the second user input terminal 16 and the connection managing module 20 can be enabled by at least one of a telemetry module, Bluetooth module, or communication module. In such embodiments, the connection managing module 20 may allow only unidirectional connection or unidirectional data transfer between the controller 14 and the first user input terminal 18, the controller 14 and the second user input terminal 16, or the first user input terminal 18 and the second user input terminal 16.
[0043] The connection managing module can block bidirectional connection or data transfer between the controller 14 and the first user input terminal 18, the controller 14 and the second user input terminal 16, or the first user input terminal 18 and the second user input terminal 16.
[0044] Further, in such embodiments, the connection managing module 20 can either provide 1) connection or data transfer between the controller 14 and the first user input terminal 18 or between the controller 14 and the second user input terminal 16, or 2) connection or data transfer between the first user input terminal 18 and the second user input terminal 16. The connection managing module 20 may only provide connection or data transfer between the controller 14 and the first user input terminal 18 or the controller 14 and the second user input terminal 16 when there is no connection or data transfer between the first user input terminal 18 and the second user input terminal 16. The connection managing module 20 may block connection or data transfer between the controller 14 and the first user input terminal 18 or the controller 14 and the second user input terminal 16 when there exists a connection or data transfer between the first user input terminal 18 and the second user input terminal 16.
In these paragraphs (and in the rest of the originally filed specifications) the connection managing module (which may be embodied as a software module in any of the first, second or third computing devices) does not recite any specific step of actually positively “determining whether there is a unidirectional data transfer” between the second and third computing device or the third and second computing device. It just states that the connection managing module may only provide connection or data transfer between when there is no connection or data transfer first and third devices. There is no written description for the condition of “determining whether a unidirectional data transfer exists” as claimed.
The dependent claims inherit the deficiency.
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 1-8 are rejected under 35 U.S.C. 103 as being unpatentable over Schulman et al (U.S. Patent Application Publication Number: US 2008/0092911 A1 hereinafter “Schulman”- PREVIOUSLY CITED) in view of Snell (U.S. Patent Number: US 6978181 B1 hereinafter “Snell”- PREVIOUSLY CITED).
Regarding claim 1 (as best understood), Schulman teaches a system for planning and/or controlling neuromodulation for a patient comprising:
a medical device (i.e. stimulator, sensor e.g. 100a,100c Fig.1, [0029]);
a first computing device (i.e. system control unit (SCU) e.g. 302 Fig.1, [0029]) configured to be in bi-directional communication with the medical device;
a second computing device (i.e. patient control unit e.g. 174 Fig.1, [0029]);
a third computing device (i.e. clinician programmer e.g. 172 Fig.1, [0029]);
Schulman does not specifically teach at least one connection managing module configured and arranged to:
determine whether there is a unidirectional data transfer from the second computing device to the third computing device, or a unidirectional data transfer from the third computing device to the second computing device, and based on the determination, blocking connection and/or data transfer between the first computing device and the second computing device, and the first computing device and the third computing device.
In a similar field of endeavor, Snell teaches an IMD and a plurality of external computing devices (i.e. programmers e.g. abstract) and further teaches communication process that enables point-to-point communication that is free of interference between any pair of participating devices by permitting only unidirectional communication between two computing devices while preventing communication from the other devices (e.g. Col. 7 line 9-20, Col.8 lines 7-25 : Snell teaches the “the programmer might want to inform other programmers to stop communicating temporarily to ensure that transmission of programming parameters over the channel is free from any interference” (e.g. Col. 8 lines 6-10) and also teaches “an alternative approach is to signal all devices to transition to a "listen only" mode to temporarily halt communication. They also teach informing other programmers of an impending operation, so then the other programmers temporarily avoid communication on that channel and “perhaps any communication on any channel” (e.g. Col. 8 lines17-22).This allows the programmer to communicate directly with one intended device, while other programmers and/or devices wait without communicating (e.g. Col. 8 lines 22-25)) and therefore they teach a connection managing module (Note: applicant’s specifications describe the connection managing module as software) configured and arranged to: determine whether there exists a unidirectional data transfer from the second computing device to the third computing device, or a unidirectional data transfer from the third computing device to the second computing device and based on the determination, blocking connection or data transfer between the first computing device and the second computing device, and the first computing device and the third computing device.
Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to modify the teachings of Schulman to permit unidirectional data transfer between two computing devices while blocking connection or data transfer between the other devices as taught by Snell in order to provide the predictable results of reducing any interference. (Note: As discussed in the response to arguments section, the claims as recited raises 112 first paragraph issues of new matter. The claims do not provide any additional limitations that preclude Snell’s teachings since Snell teaches informing the other programming device that there is going to be an impending unidirectional communication to and from between two programming devices and the other programming device should stop communication with them and therefore a determination of a unidirectional data transfer between two devices is made).
Regarding claim 2, Schulman in view of Snell teaches the invention as claimed as discussed above and Schulman further teaches that the first computing device, the second computing device, and the third computing device are configured to communicate with each other using wireless communications (i.e. transceiver e.g. Fig.1, [0029],[0033], [0034] ) .
Regarding claim 3, Schulman in view of Snell teaches the invention as claimed as discussed above and Schulman further teaches the medical device comprises a neuromodulator and/or a neurostimulator (e.g. [0015]: nerve stimulation).
Regarding claim 4, Schulman in view of Snell teaches the invention as claimed as discussed above and Schulman further teaches the first computing device comprises a controller configured to control operation of the medical device (i.e. system control unit (SCU) e.g. 302 Fig.1, [0029],[0031],[0032]).
Regarding claim 5, Schulman in view of Snell teaches the invention as claimed as discussed above and Schulman further teaches the second computing device (i.e. patient control unit, 174Fig.1, [0029]) comprises a programable device configured to allow a user to: (i) select a specific stimulation program and/or a specific input therapy parameter, (ii) alter a selected stimulation program, and/or (iii) control when and how a selected stimulation program is executed (e.g. [0030]-[0033]).
Regarding claim 6, Schulman in view of Snell teaches the invention as claimed as discussed above and Schulman further teaches the third computing device (i.e. clinician programmer, 172Fig.1, [0029], [0030]) comprises a programable device configured to allow a user to: (i) review at least one of stimulation data or patient data associated with the medical device, and/or (ii) adjust stimulation provided by the medical device (e.g. [0030]).
Regarding claims 7 and 8, Schulman in view of Snell teaches the invention as claimed as discussed above and Schulman further teaches the second computing device (i.e. patient control unit e.g. 174 Fig. 1) and the third computing device (i.e. clinician’s programmer e.g. 172 Fig.1) each include a display for presenting information (e.g. [0076]: display unit) and a user interface for receiving input (e.g. [0076] the sensor and stimulator device implanted in the patient are programmable and controllable by the patient control unit 174 and the clinician programmer 172 and therefore the devices are capable of receiving input from a user and a clinician using user interface).
Claims 9-17 are rejected under 35 U.S.C. 103 as being unpatentable over Schulman et al (U.S. Patent Application Publication Number: US 2008/0092911 A1 hereinafter “Schulman” - PREVIOUSLY CITED) in view of Lin et al (U.S. Patent Application Publication Number: US 2019/0358454 hereinafter “Lin” - PREVIOUSLY CITED) and further in view of Snell (U.S. Patent Number: US 6978181 B1 hereinafter “Snell” - PREVIOUSLY CITED).
Regarding claims 9 and 17 (as best understood), Schulman teaches a method for planning and/or controlling neuromodulation for a patient and a computer-implemented system for optimizing computer implemented tasks comprising:
accessing, from a second computing device (i.e. patient control unit e.g. 174 Fig. 1), an applications module of a first computing device (i.e. system control unit (SCU) e.g. 302 Fig.1, [0029], [0031], [0032]);
presenting to a user, at the second computing device (i.e. patient control unit e.g. 174 Fig. 1), information from the applications module (e.g. [0031]: display unit of the patient control unit 174 displays information from the SCU);
While Schulman teaches that the second computing device (i.e. patient control unit e.g. 174 Fig. 1) and the third computing device (i.e. clinician programmer e.g. 172 Fig.1, [0029]) are in bidirectional communication (e.g. Fig. 2 shows bidirectional communication between 172 and 174) and that the software that controls the operation of the programmable controller 308 of the first computing device (i.e. SCU), can be remotely downloaded, (e.g., from the clinician's programmer 174) (e.g. [0036]) and that the clinician programmer can be used to program/ command the implanted devices (e.g. [0041]), they do not specifically teach transmitting data from the second computing device (i.e. the patient control unit) to the third computing device (i.e. clinician programming unit); updating neuromodulation control data at the third computing device; transferring the updated neuromodulation control data from the third computing device to the first computing device; updating installed control commands on the second computing device with the updated neuromodulation control data; sending instructions from the second computing device to the first computing device for controlling a medical device based on the updated installed control commands; and
wherein a connection managing module is configured to control communications by: determining whether there exists a unidirectional data transfer from the second computing device to the third computing device, or a unidirectional data transfer from the third computing device to the second computing device, and based on the determination, blocking connection and/or data transfer between: the first computing device and the second computing device, and the first computing device and the third computing device.
In a similar field of endeavor, Lin teaches a medical system for providing neurostimulation therapy comprising a third computing device (i.e. clinician programmer device, program modelling system e.g. 720, 710 Fig.7), second computing device (i.e. patient programmer unit (e.g. 602 Fig.7) and a first computing device (e.g. 750 Fig.7) in bidirectional communication and transmitting data from the second computing device 602 to the third computing device710, 720 updating neuromodulation control data at the third computing device; transferring the updated neuromodulation control data from the third computing device to the first computing device; updating installed control commands on the second computing device with the updated neuromodulation control data; sending instructions from the second computing device to the first computing device for controlling a medical device based on the updated installed control commands (e.g. [0106]-[0109]). Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to modify the teachings of Schulman to include the teachings of Lin and provide updating of the neuromodulation data of the IMD and the patient programming device by the clinician/ program modeling system as taught by Lin in order to provide the predictable results of improving safety of the system and allowing only limited control of the IMD by the patient device.
Further, in a similar field of endeavor, Snell teaches an IMD and a plurality of external computing devices (i.e. programmers e.g. abstract) and further teaches communication process that enables point-to-point communication that is free of interference between any pair of participating devices by permitting only unidirectional communication between two computing devices while preventing communication from the other devices (e.g. Col. 7 line 9-20, Col.8 lines 7-25 : Snell teaches the “the programmer might want to inform other programmers to stop communicating temporarily to ensure that transmission of programming parameters over the channel is free from any interference” (e.g. Col. 8 lines 6-10) and also teaches “an alternative approach is to signal all devices to transition to a "listen only" mode to temporarily halt communication. They also teach informing other programmers of an impending operation, so then the other programmers temporarily avoid communication on that channel and “perhaps any communication on any channel” (e.g. Col. 8 lines17-22). This allows the programmer to communicate directly with one intended device, while other programmers and/or devices wait without communicating (e.g. Col. 8 lines 22-25)) and therefore they teach a connection managing module (Note: applicant’s specifications describe the connection managing module as software) configured to control communications by: determining whether there exists a unidirectional data transfer from the second computing device to the third computing device, or a unidirectional data transfer from the third computing device to the second computing device, blocking connection or data transfer between the first computing device and the second computing device, and the first computing device and the third computing device.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to further modify the teachings of Schulman in view of Lin to permit unidirectional data transfer between two computing devices while blocking connection or data transfer between the other devices as taught by Snell in order to provide the predictable results of reducing any interference. (Note: As discussed in the response to arguments section, the claims as recited raises 112 first paragraph issues of new matter. The claims do not provide any additional limitations that preclude Snell’s teachings since Snell teaches informing the other programming device that there is going to be an impending unidirectional communication to and from between two programming devices and the other programming device should stop communication with them and therefore a determination of a unidirectional data transfer between two devices is made).
Regarding claim 10, Schulman in view of Lin and Snell teaches the invention as claimed as discussed above and Schulman further teaches that the first computing device, the second computing device, and the third computing device are configured to communicate with each other using wireless communications (i.e. transceiver e.g. Fig.1, [0029],[0033], [0034] ).
Regarding claim 11, Schulman in view of Lin and Snell teaches the invention as claimed as discussed above and Schulman further teaches the medical device comprises a neuromodulator and/or a neurostimulator (e.g. [0015]: nerve stimulation).
Regarding claim 12, Schulman in view of Lin and Snell teaches the invention as claimed as discussed above and Schulman further teaches the first computing device comprises a controller configured to control operation of the medical device (i.e. system control unit (SCU) e.g. 302 Fig.1, [0029],[0031],[0032]).
Regarding claim 13, Schulman in view of Lin and Snell teaches the invention as claimed as discussed above and Schulman further teaches the second computing device (i.e. patient control unit, 174Fig.1, [0029]) comprises a programable device configured to allow a user to: (i) select a specific stimulation program and/or a specific input therapy parameter, (ii) alter a selected stimulation program, and/or (iii) control when and how a selected stimulation program is executed (e.g. [0030]-[0033]).
Regarding claim 14, Schulman in view of Lin and Snell teaches the invention as claimed as discussed above and Schulman further teaches the third computing device (i.e. clinician programmer, e.g. 172 Fig.1, [0029], [0030]) comprises a programable device configured to allow a user to: (i) review at least one of stimulation data or patient data associated with the medical device, and/or (ii) adjust stimulation provided by the medical device (e.g. [0030]).
Regarding claims 15 and 16, Schulman in view of Lin and Snell teaches the invention as claimed as discussed above and Schulman further teaches the presenting information to a patient and a healthcare provider respectively using displays (e.g. [0076]: display unit) included in each of the second computing device (i.e. patient control unit e.g. 174 Fig. 1) and the third computing device (i.e. clinician programmer, e.g. 172 Fig.1) and receiving input from a patient and a healthcare provider respectively using user interfaces included in each of the second computing device and the third computing device each (e.g. [0039], [0076]: the sensor and stimulator device implanted in the patient are programmable and controllable by the patient control unit 174 and the clinician programmer 172 and therefore the devices are capable of receiving input from a user and a clinician using user interfaces).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MALLIKA DIPAYAN FAIRCHILD whose telephone number is (571)270-7043. The examiner can normally be reached Monday- Friday 8 am-5pm EST.
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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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/MALLIKA D FAIRCHILD/Primary Examiner, Art Unit 3792
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