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 .
Claim Rejections - 35 USC § 102
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 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.
Claims 1-2, 4, 6, 8-13 and 15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kokones et al. (US 20090105787 A1).
As to claim 1, Kokones et al. discloses a medical device system (Figure 1) comprising: a programmable implantable medical device (neuro-stimulation generator, depicted as 14 in Figure 1; [0017]), configured for providing stimulations to a patient ([0017-0018]) in accordance with programmed stimulation parameters ([0017-0018]); a patient device (patient programmer, depicted as 10 in Figure 1; [0018-0020]), comprising a first interface (Figure 1; [0020-0023]; “Such control input 28 may be obtained from the patient 12 via an appropriate user interface such as a touch screen display, keypad and/or button”[0020] and “The progress input 24 can include measurements taken from sensors mounted on or otherwise coupled to the patient programmer 10, answers to rehabilitation related questions, and so on”[0023]) configured for communication and interaction with the patient (Figure 1; [0020]; “control signals, such as program parameter and stimulation mode selection signals, may also be generated based on the control input 28 and transmitted to the generator 14”) and a second interface (communication interface, depicted as 20 in Figure 1; [0020]; “A processor 26 may use the communication interface 20 to transmit the switching signal to the generator 14 wirelessly”) configured for submitting data for programming the implantable medical device (Figure 1; [0020]); and a clinician device (clinician programmer, depicted as 16 in Figure 1; [0019]), comprising a third interface ([0019]) configured for communication and interaction with a clinician (Figure 1; [0019]), wherein, for programming the implantable medical device, the patient device is configured to automatically pose at least one question to the patient via the first interface ([0020-0023, 0027]; Figure 5B), and to automatically decide upon an action according to at least one feedback from the patient (Figure 5B) entered via the first interface (Figure 1; [0038]) and to submit the adjusted stimulation parameter to the implantable medical device (Figure 1; [0019-0023]), and wherein the patient device and the clinician device are further configured to provide an option to the patient to selectively establish a communication between the patient and the clinician (Figure 1; [0023]).
As to claim 2, Kokones et al. discloses the patient device and the clinician device are further configured to provide an option to the patient to communicate with a clinician by establishing a data communication between the patient device and the clinician device (Figure 1; [0023]).
As to claim 4, Kokones et al. discloses the patient device and the clinician device are further configured to provide an option to the clinician device to establish access to data stored in the patient device using the data communication between the patient device and the clinician device (Figure 1; [0023]).
As to claim 6, Kokones et al. discloses the patient device is configured to automatically pose the at least one question in a manner mimicking an inter-human communication ([0015, 0027-0030]).
As to claim 8, Kokones et al. discloses the medical device system comprises at least one body position sensor ([0024-0025, 0037]), wherein the medical device system is configured for automatically determining a position of the patient's body ([0025]) based on signals provided by the body position sensor ([0024-0025]; Figure 2), and wherein the patient device is configured to at least one of: (i) automatically pose the at least one question to the patient in dependence of the determined position of the patient's body ([0024-0025]; “and a motion sensor 34c could be used for a motor skills task such as lifting the patient programmer off of a table and raising it above one's head. The motion sensor 34c may therefore track the speed and duration of the task and output this information for storage on the patient programmer and reporting purposes” ([0024]) and “progress module 22 also interacts with sensors external to the patient programmer to give a more complete view of the patient recovery. For example, the motion sensor 34c could interact with a sensor held by the patient during rehabilitation tasks. This interaction could indicate the distance traveled by the patient's extremity during the course of a specific rehabilitation task. Another example is that the motion sensor 34c could interact with a sensor implanted in the patient as part of the implantable therapeutic system. One possibility is that the interaction of these sensors could indicate overall movement of the patient in both body and head movement, which could be informative as to the overall rehabilitation status of the patient. Another possibility is that each of the sensors could generate independent readings, wherein the patient programmer conducts an analysis of the readings to obtain information regarding the patient's progress”([0025])).
As to claim 9, Kokones et al. discloses the action comprises at least one of: (i) an adjustment of at least one stimulation parameter ([0018-0019]; patient programmer adjustment limits for multiple programs, collect measurements and diagnostic data from the generator 14 and may be used to switch the generator 14 on and off”([0019])) and (v) posing another question to the patient via the first interface ([0015, 0027-0030]).
As to claim 10, Kokones et al. discloses the patient device is configured to submit the adjusted stimulation parameter to the implantable medical device exclusively upon the patient having authorized such submitting ([0018-0019]; patient programmer adjustment limits for multiple programs, collect measurements and diagnostic data from the generator 14 and may be used to switch the generator 14 on and off”([0019]). Therefore, since the patient programmer adjust the stimulation programs, the stimulation parameters or program adjustments are enacted and thus authorized by the patient).
As to claim 11, Kokones et al. discloses the patient device comprises a stop stimulation button ([0020]) configured for immediately instructing the implantable medical device to stop providing stimulations to the patient upon the stop stimulation button being actuated by the patient ([0020-0021]).
As to claim 12, Kokones et al. discloses a medical device system (Figure 1) comprising: (a) a programmable implantable medical device ((neuro-stimulation generator, depicted as 14 in Figure 1; [0017]), configured for providing stimulations to a patient ([0017-0018]) in accordance with programmed stimulation parameters ([0017-0018]); (b) a patient device (patient programmer, depicted as 10 in Figure 1; [0018-0020]), comprising a first interface ((Figure 1; [0020-0023]; “Such control input 28 may be obtained from the patient 12 via an appropriate user interface such as a touch screen display, keypad and/or button”[0020] and “The progress input 24 can include measurements taken from sensors mounted on or otherwise coupled to the patient programmer 10, answers to rehabilitation related questions, and so on”[0023]) configured for communication and interaction with the patient (Figure 1; [0020]; “control signals, such as program parameter and stimulation mode selection signals, may also be generated based on the control input 28 and transmitted to the generator 14”) and a second interface (communication interface, depicted as 20 in Figure 1; [0020]; “A processor 26 may use the communication interface 20 to transmit the switching signal to the generator 14 wirelessly”) configured for submitting data for programming the implantable medical device (3); and (c) a clinician device (Figure 1; [0020]); and a clinician device (clinician programmer, depicted as 16 in Figure 1; [0019]), comprising a third interface ([0019]) configured for communication and interaction with a clinician (Figure 1; [0019]), wherein the method comprises: (a) automatically posing at least one question to the patient via the first interface of the patient device (0020-0023]; Figure 5B); (b) automatically decide upon an action according to at least one feedback from the patient (Figure 5B) entered via the first interface (Figure 1; [0038]); and (c) submitting the adjusted stimulation parameter to the implantable medical device for programming the implantable medical device (Figure 1; [0019-0023]), wherein, during operation of the patient device, an option is provided to the patient to selectively establish a communication between the patient and the clinician (Figure 1; [0023]).
As to claim 13, Kokones et al. discloses the patient device and the clinician device are further configured to provide an option to the patient to communicate with a clinician by establishing a data communication between the patient device and the clinician device (Figure 1; [0023]).
As to claim 15, Kokones et al. discloses during operation of the patient device, an option is provided to the clinician to access to data stored in the patient device using the data communication between the patient device and the clinician device (Figure 1; [0023]).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Kokones et al. (US 20090105787 A1).
Kokones et al. discloses the invention substantially as claimed with communications between the patient and the clinician (Figures 1 and 4) and input buttons ([0020]) but does not explicitly disclose a button for establishing the communication between the patient and the clinician upon the clinician contact button being actuated by the patient. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the communication means between the patient and the clinician to include a button, that upon actuation, can establish communication between the patient and the clinician in order to provide the predictable results of initiating communication for real time communication and transmission in the event of an adverse event or situation at which the patient feels it is pertinent that the clinician immediately review the patient data or parameters in order to optimize treatment to meet specific patient therapeutic needs and requirements.
Claims 3 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Kokones et al. (US 20090105787 A1) in view Thompson (US 20030028082 A1).
Kokones et al. discloses the clinician device comprises a fourth interface (Figure 1; [0023]), and wherein for establishing the communication between the patient and the clinician (Figure 1; [0023]). Kokones et al. discloses the invention substantially as claimed with a patient device, clinician device and communication between the patient and the clinician, but does not explicit disclose employing an external server “configured to setup a data communication to the clinician device and the patient device via the fourth interface, wherein the data communication between the patient device and the clinician device is carried out via the external server”. Thompson discloses in Figure 4 and paragraph 47, “There are a variety of wireless mediums through which data communications could be established between programmer 20 or interface medical unit (IMU) 20' and data center 62. The communications link between Programmer 20 or IMU 20' and data center 62 could be modem 60, which is connected to programmer 20 on one side at line 63 and data center 62 at line 64 on the other side. In this case, data is transferred from data center 62 to programmer 20 via modem 60. Alternate data transmission systems include, without limitations, stationary microwave and/or RF antennas 48 being wirelessly connected to programmer 20 via tunable frequency wave delineated by line 50. Antenna 48 is in communications with data center 62 via wireless link 65. Similarly, IMU 20', mobile vehicle 52 and satellite 56 are in communications with data center 62 via wireless link 65. Further, mobile system 52 and satellite 56 are in wireless communications with programmer 20 or IMU 20' via tunable frequency waves 54 and 58, respectively”. Thompson discloses a data center or modem that functions as the external server ([0025, 0028, 0047]). It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the communications of Kokones et al. to include an external server as disclosed by Thompson in order to provide the predictable results of facilitating communications and wireless transmission of data between the patient and clinician devices. Furthermore, external servers are well known components in wireless transmission, particularly with medical devices that wirelessly communicate with a programmer or clinician.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Kokones et al. (US 20090105787 A1) in view Gerber et al. (US 20120277621 A1).
Kokones et al. discloses a patient device and an implantable medical device comprises at least one implantable electrode for stimulation ([0018]) but does not explicitly disclose the “medical device system is configured for automatically determining a position of the implantable electrode relative to one of: (i) the patient's body, or (ii) a position of a neighboring electrode, and wherein the patient device is configured to at least one of: (i) automatically pose the at least one question to the patient in dependence of the determined position of the implantable electrode, or (ii) automatically decide upon an action according to at least one feedback from the patient in dependence of the determined position of the implantable electrode”. Gerber et al. discloses determining a position of an implantable electrode relative to a neighboring electrode (Figure 8; [0064-0077]) and automatically decide upon an action according to at least one feedback from the patient in dependence of the determined position of the implantable electrode ([0064-0077]; “A patient or clinician, using clinician programmer 26 or patient programmer 28, identifies a first electrode that produced the first stimulation threshold. The programmer then associates the first stimulation threshold with the first electrode. IMD 12 increases the stimulation intensity from the first stimulation threshold until a second stimulation threshold is reached. In some examples, the programmer 26 is again used to identify an electrode responsible for the second stimulation threshold. The steps of increasing stimulation intensity until a threshold is reached, identifying an electrode responsible for the threshold, and association of the electrode with the threshold may be repeated until each electrode has been associated with a threshold”[0069]). It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the patient device of Kokones et al. to include the ability determining a position of the implantable electrode relative to a position of a neighboring electrode and automatically decide upon an action according to at least one feedback from the patient in dependence of the determined position of the implantable electrode as disclosed by Gerber et al. in order to provide the predictable results of optimizing treatment to meet specific patient therapeutic needs and requirements.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALYSSA M ALTER whose telephone number is (571)272-4939. The examiner can normally be reached M-F 8am-4pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David E 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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/ALYSSA M ALTER/Primary Examiner, Art Unit 3796