DETAILED ACTION
Acknowledgements
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 1-15 are pending.
This action is Final.
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 1-15 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.
The independent claims have been amended to recite the limitations “an extracorporeal device adapted to be attached to a patient's skin,.. wherein the extracorporeal device comprises: - a transceiver unit implanted into the patient's body or attached to the patient's skin and adapted to receive the intra-body communication signal,” (claim 1 representative), which is rejected for new matter. Applicant has amended the claims to include an optional configuration where the extracorporeal transceiver unit is implanted into the patient’s body which is new matter. The response identifies paragraphs 54 and 58 of the PGPub as support, but there is no support in these passages for the limitations of the transceiver unit being implanted into the patient’s body. In fact, such is counter to the known meaning of extracorporeal device and the description which commonly refers to the element as worn. In medicine, extracorporeal means occurring or operating outside the body. The term comes from the Latin extra- (“outside”) and corpus (“body”). It is used to describe any medical procedure, device, or process that functions externally rather than inside the body. Hence, a component implanted would be against the accepted meaning in addition to the entire concept being new matter. As such, one of skill in the art would not have recognized applicant was in possession of the claimed invention at the time the application was filed. The dependent claims are rejected for depending on a rejected claim.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-15 are 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.
The independent claims have been amended to recite the limitations “an extracorporeal device adapted to be attached to a patient's skin,.. wherein the extracorporeal device comprises: - a transceiver unit implanted into the patient's body or attached to the patient's skin and adapted to receive the intra-body communication signal,” (claim 1 representative), which is rejected for being inconsistent with the disclosure as filed. Applicant has amended the claims to include an optional configuration where the extracorporeal transceiver unit is implanted into the patient’s body which is new matter as addressed above. The response identifies paragraphs 54 and 58 of the PGPub as support, but there is no support in these passages for the limitations of the transceiver unit being implanted into the patient’s body. In fact, such is counter to the known meaning of extracorporeal device and the description which commonly refers to the element as worn. In medicine, extracorporeal means occurring or operating outside the body. The term comes from the Latin extra- (“outside”) and corpus (“body”). It is used to describe any medical procedure, device, or process that functions externally rather than inside the body. Hence, a component implanted would be against the accepted meaning in addition to the entire concept being new matter. As such, the metes and bounds of the claim are unclear which renders the claim indefinite. The dependent claims are rejected for depending on a rejected claim.
Regarding claim 7, the limitations “the data communication connection to the active IMD” lacks proper antecedent basis.
The dependent claims are rejected for depending on a rejected claim.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claims 1-9 are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101). Under a broadest reasonable interpretation, the limitations “a transceiver unit implanted into the patient's body or attached to the patient's skin and adapted to receive the intra-body communication signal” are directed to or encompass human organisms. The rejection can be overcome by amended the limitation to read “a transceiver unit adapted to be implanted into the patient's body or adapted to be attached to the patient's skin and adapted to receive the intra-body communication signal”. The dependent claims are rejected for depending on a rejected claim.
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.
Claims 1-8, 10-14 are rejected under 35 U.S.C. 103 as being unpatentable over Gerber et al. (Gerber, US 2006/0020225) in view of Poore (US 5,697,959) and Gerber (Gerber’388, US 2007/0100388) and Von Arx et al. (Von Arx, US 2006/0009818).
Regarding claim 1, Gerber teaches a medical system comprising
an active implantable medical device (IMD) (see at least Figures 1-2 interpreted as element 12, also present in additional Figures and descriptions; it is noted that the document uses 18 is some Figures/passages, but such also means monitor 12 and not bladder 28/18 as is readably apparent, this notice serves for all recitations of the claim rejection) and
an extracorporeal device adapted to be attached to a patient's skin (see at least Figures 1, 3 interpreted as element 14, also present in additional Figures and descriptions, [0056]; it is noted that it is readably apparent that element 22 is mislabeled in Figure 3 and readably apparent that such is element 14, this notice serves for all recitations of the claim rejection; [0062] “External controller 14 may take the form of a portable, handheld device, like a pager or cell phone, that can be carried by patient 12. External controller 14 may include an internal antenna, an external antenna protruding from the recorder, or an external antenna that extends from the recorder on a cable and is attached to the body of patient 12 at a location proximate to the location of monitor 12 to improve wireless communication reliability. Also, in some embodiments, external controller 14 also may receive operational or status information from monitor 12, and may be configured to actively configure and interrogate the monitor to receive the information.”), and the active IMD comprises:
- a measurement unit adapted to generate patient data and determine data regarding at least one bodily parameter of the patient, wherein the active IMD is implantable within a body of the patient (see at least Figure 2, sensor(s) 26, [0037], [0045]-[0050] urodynamic information, [0071], [0088] a first of many voiding events and related data, where data events are captured over a period of several days),
- a processor adapted to process the at least one bodily parameter data and to detect at least one first condition associated with a plurality of predefined conditions based on the at least one bodily parameter data (see at least Figure 2 processor 24, [0041] “Processor 24 controls telemetry interface 30 and handles processing and storage of information obtained by sensor 26…Memory 28 may store program instructions that, when executed by processor 24, cause the controller to perform the functions ascribed to it herein. For example, memory 28 may store instructions for processor 24 to execute in support of control of wireless telemetry interface 30 and control of, and processing of information obtained by, sensor 26.”, [0046] “Pressure, contractile force or other measurements may be used to detect bladder or urinary sphincter functions in order to automatically detect the onset of an attempt to void urine from bladder 18. For example, an elevated pressure or force, or change in pressure or force, may indicate a contraction of the bladder muscle, which may be used to generate a voiding event activation command to trigger collection of urodynamic information for recording in a voiding diary. As a further example, if monitor 12 is implanted within urethra 20, the voiding event may be detected by detecting the presence of urine in the urethra, e.g., by flow, pressure, temperature, or impedance sensing. Accordingly, in some embodiments, the use of two monitors 12 may be desirable, e.g., one in bladder 18 and one in urethra 20. Hence, for automated detection, processor 24 may periodically sample and monitor the output of sensor 26.”), and
- a communication unit adapted to periodically send an intra-body communication signal representing the at least one detected first condition to the extracorporeal device, the intra-body communication signal being a short encoded beacon travelling through the patient's body (see at least Figure 2 element 30 data transmitted periodic basis would not be long continuous stream which meets the intended signal form of short and encoded with the data traveling between the implantable device and external device; [0040]-[0042], [0046], [0051], [0055] “The most recently stored segment or segments of information may be transmitted via uplink telemetry transmission from monitor 12 to external controller 14 on a continuous or periodic basis, or when a memory interrogation telemetry session is initiated by a medical care provider using the external controller.” [0061] “proximal inductive interaction of external controller 14 with monitor 12” [0062] External controller 14 may include an internal antenna, an external antenna protruding from the recorder, or an external antenna that extends from the recorder on a cable and is attached to the body of patient 12 at a location proximate to the location of monitor 12 to improve wireless communication reliability.” [0066]),
wherein the extracorporeal device comprises:
- a transceiver unit adapted to receive the intra-body communication signal (see at least Figure 3 element 40; [0057] “Processor 34 controls telemetry interface 40 to obtain urodynamic information from monitor 18. Processor 34 also may control telemetry interface 40 to receive information from monitor 18 on a substantially continuous basis, at periodic intervals, or only upon receipt of a user activation command. Hence, external controller 14 may obtain on ongoing, up-to-date indication of the physiological conditions sensed by monitor 12. More particularly, however, external controller 14 is configured to respond to a voiding event activation command 46 entered by patient 16 via user input device 42. In response to the voiding event activation command 46, external controller 14 generates an activation control signal and transmits the control signal to monitor 12 via telemetry interface 40.” [0061]), and
- a notification unit adapted to provide at least one predefined notification signal to the patient to motivate the patient to perform a predefined action based on the received intra-body communication signal (notification signal interpreted as output, see at least Figure 3 element 44, Figures 11-12 element 94; [0059] “External controller 14 permits a user to receive urodynamic information obtained by a sensor carried by monitor 12 during the course of a voiding event. In addition, external controller 14 may process and record information obtained from monitor 12, and present the information to a user via display 44 or other output media. In some embodiments, the information may include one or more advisories with respect to the presence or level of a urodynamic parameter. In addition, the recorded information may be transmitted from external device 14 to other external devices for presentation, archival or further analysis. [0072], [0087]-[0088]).
However, the following features when considered as a whole: wherein the active IMD is configured to provide active therapeutic impact to the patient's body, the transceiver unit implanted into the patient's body or attached to the patient's skin, wherein the transceiver unit of the extracorporeal device is further adapted to send a termination signal to the communication unit of the active IMD, wherein the communication unit of the active IMD is further adapted to receive the termination signal and to subsequently terminate sending the intra-body communication signal representing the at least one detected first condition, and wherein the measurement unit continues to generate additional patient data and determine additional data regarding at least one bodily parameter and the processor continues to process the additional at least one bodily parameter data for detecting at least one second condition after the sending of the intra-body communication signal is terminated, are not directly taught.
Gerber does additionally teach that the sensor unit can be used to continuously monitor signals which include event signals and those between events, which include first, second, and further events, and that functions continue to occur at intervals (see at least [0034] In other embodiments, rather than immediately transmitting the urodynamic information to external controller 14, monitor 12 may initially store the information internally for subsequent wireless transmission to external controller 14 or another device. Hence, in some embodiments, the urodynamic information may be stored within monitor 12, and later transmitted to external controller 14 upon interrogation of the monitor. Interrogation may be initiated by the patient 16 by entering a command into external controller 14. In further embodiments, monitor 12 may store the information internally on a persistent basis for later retrieval by external controller 14, or upon explantation of the monitor. [0051] In some embodiments, monitor 12 also may be capable of continuously or periodically performing urodynamic testing over an extended period of time, encompassing voiding events and measurements between voiding events. [0046] “Hence, for automated detection, processor 24 may periodically sample and monitor the output of sensor 26.”), and the periodically can include interrogation signals by the extracorporeal device can be used to send the data collected by the monitor to the extracorporeal device (see at least [0034] In other embodiments, rather than immediately transmitting the urodynamic information to external controller 14, monitor 12 may initially store the information internally for subsequent wireless transmission to external controller 14 or another device. Hence, in some embodiments, the urodynamic information may be stored within monitor 12, and later transmitted to external controller 14 upon interrogation of the monitor. Interrogation may be initiated by the patient 16 by entering a command into external controller 14. In further embodiments, monitor 12 may store the information internally on a persistent basis for later retrieval by external controller 14, or upon explantation of the monitor. [0055] The most recently stored segment or segments of information may be transmitted via uplink telemetry transmission from monitor 12 to external controller 14 on a continuous or periodic basis, or when a memory interrogation telemetry session is initiated by a medical care provider using the external controller. [0057] Processor 34 controls telemetry interface 40 to obtain urodynamic information from monitor 18. Processor 34 also may control telemetry interface 40 to receive information from monitor 18 on a substantially continuous basis, at periodic intervals, or only upon receipt of a user activation command. [0062] Also, in some embodiments, external controller 14 also may receive operational or status information from monitor 12, and may be configured to actively configure and interrogate the monitor to receive the information.).
Poore teaches a related system for communications with an implantable unit (see Figure 1), and teaches a process of using interrogation signals to establish telemetry links and using an external end button to send an end signal to stop communications (see col. 12 lines 64-col. 13 line 6, col. 13 lines 23-29; col. 20 lines 20-26 Finally, if the "End" button 335 is depressed, a "termination" command signal is generated and passed to the pacemaker thereby halting the pacemaker communication routine and the APS-II returns to the Main Menu screen display 310 until the next "Interrogate" command is given to re-establish the telemetry link with the pacemaker); which when combined with the additional teachings above in the Gerber continuous measurements and usage of interrogation reasonably teaches the claimed functional features of: wherein the transceiver unit of the extracorporeal device is further adapted to send a termination signal to the communication unit of the active IMD, wherein the communication unit of the active IMD is further adapted to receive the termination signal and to subsequently terminate sending the intra-body communication signal representing the at least one detected first condition, and wherein the measurement unit continues to generate additional patient data and determine additional data regarding at least one bodily parameter and the processor continues to process the additional at least one bodily parameter data for detecting at least one second condition after the sending of the intra-body communication signal is terminated. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine prior art elements according to known methods to yield predictable results of including an end button in an extracorporeal unit in order to send end/terminate signals to an implantable unit to stop telemetry communications from the implantable as such can further conserve power consumption by only having telemetry links when initiated and ended by a user.
While Gerber teaches IMD of “implantable device with incorporated active on-board circuitry”, the intended use of the argued special definition of active IMD to be “an active implantable medical device adapted for providing active therapeutic impact to a patient’s body” and present in the limitations wherein the active IMD is configured to provide active therapeutic impact to the patient's body are not directly taught.
However, Gerber’388 teaches the intended use as the sensor can be included in a system that provides therapy. Such is as much stated by Gerber’388 which incorporates by reference the disclosure of Gerber (see at least Figures 1, 4, [0037], [0033] “In embodiments that include sensor 20, neurostimulator 12 may receive information from sensor 20 via wireless telemetry…In alternative embodiments, sensor 20 may be integrated within the housing of neurostimulator 12 or coupled to the neurostimulator 12 via one or more leads”). It would have been obvious to one of ordinary skill in the art (such as Gerber) before the effective filing date of the claimed invention to combine the sensor of Gerber into a neurostimulator capable structure as taught by Gerber’388 in order to allow for treatment when a diagnosis is made of a condition such as incontinence.
Von Arx teaches a related system which can be used in any implantable system for communication between external components and internal components (see at least [0032]), and teaches the usage of telemetry systems which can communicate via different communication protocols, including acoustical, where an external device has a coupler on the skin in order to allow for communication with a coupler on an implant for the benefit of decreased power consumption relative to inductive or radio communication (see at least [0037]), which reasonably teaches the transceiver unit implanted into the patient's body or attached to the patient's skin (see at least [0032], [0039]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine prior art elements according to known methods to yield predictable results of using an acoustic coupler on the skin of an individual for communications with an implanted device in order to conserve power more efficiently.
Regarding claim 2, the limitations are met by Gerber in view of Poore and Gerber’388 and Von Arx, where the combination teaches the medical system according to claim 1, wherein, the transceiver unit of the extracorporeal device is configured to send the termination signal automatically to the communication unit of the active IMD, or the transceiver unit of the extracorporeal device is configured to send the termination signal to the communication unit of the active IMD after the at least one predefined notification signal is acknowledged by the patient (see cited documents, especially Poore col. 20 lines 20-26 Finally, if the "End" button 335 is depressed, a "termination" command signal is generated and passed to the pacemaker thereby halting the pacemaker communication routine and the APS-II returns to the Main Menu screen display 310 until the next "Interrogate" command is given to re-establish the telemetry link with the pacemaker). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine prior art elements according to known methods to yield predictable results of including an end button in an extracorporeal unit in order to send end/terminate signals to an implantable unit to stop telemetry communications from the implantable as such can further conserve power consumption by only having telemetry links when initiated and ended by a user.
Regarding claim 3, the limitations are met by Gerber in view of Poore and Gerber’388 and Von Arx, where Von Arx teaches wherein the intra-body communication signal is an acoustic signal, an electrical signal and/or an impedance-based signal (see at least [0032], [0039]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine prior art elements according to known methods to yield predictable results of using an acoustic coupler on the skin of an individual for communications with an implanted device in order to conserve power more efficiently.
Regarding claim 4, the limitations are met by Gerber in view of Poore and Gerber’388 and Von Arx, where Gerber teaches wherein the at least one predefined notification signal comprises a visual signal, haptic/tactile signal, and/or an acoustic signal (see at least Figure 11, [0059], [0072], [0087]-[0088]).
Regarding claim 5, the limitations are met by Gerber in view of Poore and Gerber’388 and Von Arx, where Gerber teaches wherein the extracorporeal device is a smart watch, a wrist band, a mobile phone adapted to be worn in direct physical contact with the patient's skin and/or a patch device (see at least [0062]).
Regarding claim 6, the limitations are met by Gerber in view of Poore and Gerber’388 and Von Arx, where Gerber teaches wherein the at least one predefined notification signal to motivate the patient further includes: a reporting to an user of the at least one first condition detected by the active IMD, and/or an invitation of the patient to take a medication, and/or an invitation of the patient to visit a healthcare professional (see at least Figure 11, [0059], [0072], [0087]-[0088]).
Regarding claim 7, the limitations are met by Gerber in view of Poore and Gerber’388 and Von Arx, where Gerber teaches the system includes a patient device (see at least [0034] “another device”), wherein the system establishes the data communication connection to the active IMD (see at least [0034] “In other embodiments, rather than immediately transmitting the urodynamic information to external controller 14, monitor 12 may initially store the information internally for subsequent wireless transmission to external controller 14 or another device.”), but as modified in the rejection of claim 1 does not directly teach any limitations of the “another device” such that the limitations of the patient device is configured to send the at least one bodily parameter data determined by the active IMD to a remote services infrastructure, and/or the patient device is configured to provide access to the IMD to a user by means of the patient device or by means of the remote services infrastructure via the patient device are not directly taught.
As discussed in claim 1, Gerber’388 teaches a related device in monitoring sensors inside a bladder (see at least [0032]-[0033]), and teaches another device that can communicate with both internal and remote networks in the form of a programmer and that such programmer can be used to interact with the implantable sensor and other devices and reasonably teaches the patient device is configured to send the at least one bodily parameter data collected by the active IMD to a remote services infrastructure, and/or the patient device is configured to provide access to the active IMD to a user by means of the patient device or by means of the remote services infrastructure via the patient device (see at least Figure 1 [0033], [0039], [0041], [0053], [0054]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include a programmer type device capable of integration into a system with a recorder type device in order to allow for internal programming controls of internal devices by authorized user, in addition to further external communication of internal device status with remote networks by such device in order to allow for increased monitoring and control of a patient’s disease management.
Regarding claim 8, the limitations are met by Gerber in view of Poore and Gerber’388 and Van Arx, where Gerber teaches wherein the at least one bodily parameter data determined by the active IMD comprises: specific information related to the at least one first condition recognized by the active IMD, and/or data determined by the active IMD for a follow-up examination (see at least Figures 11-12, [0036], [0066], [0087]-[0088]).
Regarding claim 10, Gerber teaches a method for operation of a medical system comprising an active implantable medical device (IMD) (see at least Figures 1-2 interpreted as element 12, also present in additional Figures and descriptions; it is noted that the document uses 18 is some Figures/passages, but such also means monitor 12 and not bladder 28/18 as is readably apparent, this notice serves for all recitations of the claim rejection) and an extracorporeal device attached to a patient's skin (see at least Figures 1, 3 interpreted as element 14, also present in additional Figures and descriptions, [0056]; it is noted that it is readably apparent that element 22 is mislabeled in Figure 3 and readably apparent that such is element 14, this notice serves for all recitations of the claim rejection; [0062] “External controller 14 may take the form of a portable, handheld device, like a pager or cell phone, that can be carried by patient 12. External controller 14 may include an internal antenna, an external antenna protruding from the recorder, or an external antenna that extends from the recorder on a cable and is attached to the body of patient 12 at a location proximate to the location of monitor 12 to improve wireless communication reliability. Also, in some embodiments, external controller 14 also may receive operational or status information from monitor 12, and may be configured to actively configure and interrogate the monitor to receive the information.”), comprising the following steps:
- generating patient data and determining data regarding at least one bodily parameter of the patient by a measurement unit of the active IMD, wherein the active IMD is implantable within a body of the patient (see at least Figure 2, sensor(s) 26, [0037], [0045]-[0050] urodynamic information),
- processing the at least one bodily parameter data and detecting at least one first condition of a plurality of predefined conditions based on the at least one bodily parameter data by a processor of the active IMD (see at least Figure 2 processor 24, [0041] “Processor 24 controls telemetry interface 30 and handles processing and storage of information obtained by sensor 26…Memory 28 may store program instructions that, when executed by processor 24, cause the controller to perform the functions ascribed to it herein. For example, memory 28 may store instructions for processor 24 to execute in support of control of wireless telemetry interface 30 and control of, and processing of information obtained by, sensor 26.”, [0046] “Pressure, contractile force or other measurements may be used to detect bladder or urinary sphincter functions in order to automatically detect the onset of an attempt to void urine from bladder 18. For example, an elevated pressure or force, or change in pressure or force, may indicate a contraction of the bladder muscle, which may be used to generate a voiding event activation command to trigger collection of urodynamic information for recording in a voiding diary. As a further example, if monitor 12 is implanted within urethra 20, the voiding event may be detected by detecting the presence of urine in the urethra, e.g., by flow, pressure, temperature, or impedance sensing. Accordingly, in some embodiments, the use of two monitors 12 may be desirable, e.g., one in bladder 18 and one in urethra 20. Hence, for automated detection, processor 24 may periodically sample and monitor the output of sensor 26.” [0071], [0088] a first of many voiding events and related data, where data events are captured over a period of several days),
- periodically sending an intra-body communication signal representing the at least one detected first condition by a communication unit of the active IMD to the extracorporeal device, the intra-body communication signal being a short encoded beacon travelling through the patient's body (see at least Figure 2 element 30 data transmitted periodic basis would not be long continuous stream which meets the intended signal form of short and encoded with the data traveling between the implantable device and external device; [0040]-[0042], [0046], [0051], [0055] “The most recently stored segment or segments of information may be transmitted via uplink telemetry transmission from monitor 12 to external controller 14 on a continuous or periodic basis, or when a memory interrogation telemetry session is initiated by a medical care provider using the external controller.” [0061] “proximal inductive interaction of external controller 14 with monitor 12” [0062] External controller 14 may include an internal antenna, an external antenna protruding from the recorder, or an external antenna that extends from the recorder on a cable and is attached to the body of patient 12 at a location proximate to the location of monitor 12 to improve wireless communication reliability.” [0066]),
- receiving the intra-body communication signal by a transceiver unit of the extracorporeal device (see at least Figure 3 element 40; [0057] “Processor 34 controls telemetry interface 40 to obtain urodynamic information from monitor 18. Processor 34 also may control telemetry interface 40 to receive information from monitor 18 on a substantially continuous basis, at periodic intervals, or only upon receipt of a user activation command. Hence, external controller 14 may obtain on ongoing, up-to-date indication of the physiological conditions sensed by monitor 12. More particularly, however, external controller 14 is configured to respond to a voiding event activation command 46 entered by patient 16 via user input device 42. In response to the voiding event activation command 46, external controller 14 generates an activation control signal and transmits the control signal to monitor 12 via telemetry interface 40.” [0061]),
- providing at least one predefined notification signal by the extracorporeal device to the patient to motivate the patient to perform a predefined action based on the received intra-body communication signal (notification signal interpreted as output, see at least Figure 3 element 44, Figures 11-12 element 94; [0059] “External controller 14 permits a user to receive urodynamic information obtained by a sensor carried by monitor 12 during the course of a voiding event. In addition, external controller 14 may process and record information obtained from monitor 12, and present the information to a user via display 44 or other output media. In some embodiments, the information may include one or more advisories with respect to the presence or level of a urodynamic parameter. In addition, the recorded information may be transmitted from external device 14 to other external devices for presentation, archival or further analysis. [0072], [0087]-[0088]),
However, the following features when considered as a whole: the active IMD being configured to provide active therapeutic impact to the patient's body, the transceiver unit being implanted into the patient's body or attached to the patient's skin, sending a termination signal by the transceiver unit of the extracorporeal device to the communication unit of the active IMD, receiving the termination signal by the communication unit of the active IMD and subsequently terminating sending the intra-body communication signal representing the at least one detected first condition, and continuing to generate additional patient data and determine additional data regarding at least one bodily parameter and process the additional at least one bodily parameter data for detecting at least one second condition after sending of the intra-body communication signal is terminated, are not directly taught.
Gerber does additionally teach that the sensor unit can be used to continuously monitor signals which include event signals and those between events (see at least [0034] In other embodiments, rather than immediately transmitting the urodynamic information to external controller 14, monitor 12 may initially store the information internally for subsequent wireless transmission to external controller 14 or another device. Hence, in some embodiments, the urodynamic information may be stored within monitor 12, and later transmitted to external controller 14 upon interrogation of the monitor. Interrogation may be initiated by the patient 16 by entering a command into external controller 14. In further embodiments, monitor 12 may store the information internally on a persistent basis for later retrieval by external controller 14, or upon explantation of the monitor. [0051] In some embodiments, monitor 12 also may be capable of continuously or periodically performing urodynamic testing over an extended period of time, encompassing voiding events and measurements between voiding events.), and the periodically can include interrogation signals by the extracorporeal device can be used to send the data collected by the monitor to the extracorporeal device (see at least [0034] In other embodiments, rather than immediately transmitting the urodynamic information to external controller 14, monitor 12 may initially store the information internally for subsequent wireless transmission to external controller 14 or another device. Hence, in some embodiments, the urodynamic information may be stored within monitor 12, and later transmitted to external controller 14 upon interrogation of the monitor. Interrogation may be initiated by the patient 16 by entering a command into external controller 14. In further embodiments, monitor 12 may store the information internally on a persistent basis for later retrieval by external controller 14, or upon explantation of the monitor. [0055] The most recently stored segment or segments of information may be transmitted via uplink telemetry transmission from monitor 12 to external controller 14 on a continuous or periodic basis, or when a memory interrogation telemetry session is initiated by a medical care provider using the external controller. [0057] Processor 34 controls telemetry interface 40 to obtain urodynamic information from monitor 18. Processor 34 also may control telemetry interface 40 to receive information from monitor 18 on a substantially continuous basis, at periodic intervals, or only upon receipt of a user activation command. [0062] Also, in some embodiments, external controller 14 also may receive operational or status information from monitor 12, and may be configured to actively configure and interrogate the monitor to receive the information.).
Poore teaches a related system for communications with an implantable unit (see Figure 1), and teaches a process of using interrogation signals to establish telemetry links and using an external end button to send an end signal to stop communications (see col. 12 lines 64-col. 13 line 6, col. 13 lines 23-29; col. 20 lines 20-26 Finally, if the "End" button 335 is depressed, a "termination" command signal is generated and passed to the pacemaker thereby halting the pacemaker communication routine and the APS-II returns to the Main Menu screen display 310 until the next "Interrogate" command is given to re-establish the telemetry link with the pacemaker); which when combined with the additional teachings above in the Gerber continuous measurements and usage of interrogation reasonably teaches the claimed functional features of sending a termination signal by the transceiver unit of the extracorporeal device to the communication unit of the active IMD, receiving the termination signal by the communication unit of the active IMD and subsequently terminating sending the intra-body communication signal representing the at least one detected first condition, and continuing to generate additional patient data and determine additional data regarding at least one bodily parameter and process the additional at least one bodily parameter data for detecting at least one second condition after sending of the intra-body communication signal is terminated. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine prior art elements according to known methods to yield predictable results of including an end button in an extracorporeal unit in order to send end/terminate signals to an implantable unit to stop telemetry communications from the implantable as such can further conserve power consumption by only having telemetry links when initiated and ended by a user.
While Gerber teaches IMD of “implantable device with incorporated active on-board circuitry”, the intended use of the argued special definition of active IMD to be “an active implantable medical device adapted for providing active therapeutic impact to a patient’s body” and present in the limitations the active IMD being configured to provide active therapeutic impact to the patient's body are not directly taught.
However, Gerber’388 teaches the intended use as the sensor can be included in a system that provides therapy. Such is as much stated by Gerber’388 which incorporates by reference the disclosure of Gerber (see at least Figures 1, 4, [0037], [0033] “In embodiments that include sensor 20, neurostimulator 12 may receive information from sensor 20 via wireless telemetry…In alternative embodiments, sensor 20 may be integrated within the housing of neurostimulator 12 or coupled to the neurostimulator 12 via one or more leads”). It would have been obvious to one of ordinary skill in the art (such as Gerber) before the effective filing date of the claimed invention to combine the sensor of Gerber into a neurostimulator capable structure as taught by Gerber’388 in order to allow for treatment when a diagnosis is made of a condition such as incontinence.
Von Arx teaches a related system which can be used in any implantable system for communication between external components and internal components (see at least [0032]), and teaches the usage of telemetry systems which can communicate via different communication protocols, including acoustical, where an external device has a coupler on the skin in order to allow for communication with a coupler on an implant for the benefit of decreased power consumption relative to inductive or radio communication (see at least [0037]), which reasonably teaches the transceiver unit implanted into the patient's body or attached to the patient's skin (see at least [0032], [0039]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine prior art elements according to known methods to yield predictable results of using an acoustic coupler on the skin of an individual for communications with an implanted device in order to conserve power more efficiently.
Regarding claim 11, the limitations are met by Gerber in view of Poore and Gerber’388 and Von Arx, where the combination teaches wherein, the termination signal is sent automatically by the transceiver unit of the extracorporeal device to the communication unit of the active IMD, or the termination signal is sent by the transceiver unit of the extracorporeal device to the communication unit of the active IMD after the notification signal is acknowledged by the patient (see cited documents, especially Poore col. 20 lines 20-26 Finally, if the "End" button 335 is depressed, a "termination" command signal is generated and passed to the pacemaker thereby halting the pacemaker communication routine and the APS-II returns to the Main Menu screen display 310 until the next "Interrogate" command is given to re-establish the telemetry link with the pacemaker). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine prior art elements according to known methods to yield predictable results of including an end button in an extracorporeal unit in order to send end/terminate signals to an implantable unit to stop telemetry communications from the implantable as such can further conserve power consumption by only having telemetry links when initiated and ended by a user.
Regarding claim 12, the limitations are met by Gerber in view of Poore and Gerber’388 and Von Arx, where Gerber teaches wherein the at least one predefined notification signal to motivate the patient further includes: a reporting to a user of the at least one first condition detected by the active IMD, an invitation of the patient to take a medication, and/or an invitation of the patient to visit a healthcare professional (see at least Figure 11, [0059], [0072], [0087]-[0088]).
Regarding claim 13, the limitations are met by Gerber in view of Poore and Gerber’388 and Von Arx, where Gerber teaches use of the system to include patient device (see at least [0034] “another device”), wherein establishing a data communication to the active IMD (see at least [0034] “In other embodiments, rather than immediately transmitting the urodynamic information to external controller 14, monitor 12 may initially store the information internally for subsequent wireless transmission to external controller 14 or another device.”), but as modified in the rejection of claim 10 does not directly teach any limitations of the “another device” such that the limitations of the sending the at least one bodily parameter data determined by the active IMD to a remote services infrastructure via a patient device, and/or accessing the active IMD via the patient device or by means of a remote services infrastructure via the patient device are not directly taught.
As discussed in claim 10, Gerber’388 teaches a related device in monitoring sensors inside a bladder (see at least [0032]-[0033]), and teaches another device that can communicate with both internal and remote networks in the form of a programmer and that such programmer can be used to interact with the implantable sensor and other devices and reasonably teaches sending the at least one bodily parameter data determined by the active IMD to a remote services infrastructure via a patient device, and/or accessing the active IMD via the patient device or by means of a remote services infrastructure via the patient device (see at least Figure 1 [0033], [0039], [0041], [0053], [0054]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include a programmer type device capable of integration into a system with a recorder type device in order to allow for internal programming controls of internal devices by authorized user, in addition to further external communication of internal device status with remote networks by such device in order to allow for increased monitoring and control of a patient’s disease management.
Regarding claim 14, the limitations are met by Gerber in view of Poore and Gerber’388 and Von Arx, where Gerber teaches further comprising sending the at least one bodily parameter data determined by the active IMD to the remote services infrastructure, wherein the at least one bodily parameter data includes: specific information related to the detected at least one first condition recognized by the active IMD, and/or information/data for a follow-up examination (see at least Figures 11-12, [0036], [0066], [0069]-[0070], [0087]-[0088]).
Claims 9, 15 are rejected under 35 U.S.C. 103 as being unpatentable over Gerber et al. (Gerber, US 2006/0020225) in view of Poore (US 5,697,959) and Gerber (Gerber’388, US 2007/0100388) and Von Arx et al. (Von Arx, US 2006/0009818) as applied to claims 1, 10 above, and further in view of Katra et al (Katra, US 2020/0357513).
Regarding claim 9, the limitations are met by Gerber in view of Poore and Gerber’388 and Von Arx, where Gerber teaches providing a notification signal (notification signal interpreted as output, see at least Figure 3 element 44, Figures 11-12 element 94; [0059] “External controller 14 permits a user to receive urodynamic information obtained by a sensor carried by monitor 12 during the course of a voiding event. In addition, external controller 14 may process and record information obtained from monitor 12, and present the information to a user via display 44 or other output media. In some embodiments, the information may include one or more advisories with respect to the presence or level of a urodynamic parameter. In addition, the recorded information may be transmitted from external device 14 to other external devices for presentation, archival or further analysis. [0072], [0087]-[0088]), in a network system (see Figure 6), but does not directly teach wherein the at least one predefined notification signal provided by the extracorporeal device further comprises information from a remote service infrastructure, wherein the information is sent: from the remote service infrastructure to the extracorporeal device, or from the remote service infrastructure via a patient device to the extracorporeal device.
Katra teaches a related system for monitoring and communicating with implantable devices with sensing capabilities (see at least abstract, title, [0142]), and teaches a limitation of sending information from a networked device to a patient interface for desired medical interventions based on physician direction such as a basis for potential infection of the implanted area, which reasonably teaches the claimed features (see at least Figures, 1, 23,[0134] “In some examples, the clinician may enter instructions for a medical intervention for patient 4 into an application executed by computing device 2, such as based on a status of a patient condition determined by another one of computing device(s) 2, medical device(s) 17, edge device(s) 12, server(s) 94, or any combination thereof, or based on other patient data known to the clinician. The patient condition may include an implant status, such as a potential infection at an implantation site of the implant. Computing device 2 of a user may receive the instructions, via network 10. In return, computing device 2 may display a message on a display device indicating the medical intervention message.”). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine prior art elements according to known methods to yield predictable results of displaying information for intervention to a patient in order to alert the patient to critical conditions highlighted by a physician monitoring networked data.
Regarding claim 15, the limitations are met by Gerber in view of Poore and Gerber’388 and Von Arx, where Gerber teaches providing a notification signal (notification signal interpreted as output, see at least Figure 3 element 44, Figures 11-12 element 94; [0059] “External controller 14 permits a user to receive urodynamic information obtained by a sensor carried by monitor 12 during the course of a voiding event. In addition, external controller 14 may process and record information obtained from monitor 12, and present the information to a user via display 44 or other output media. In some embodiments, the information may include one or more advisories with respect to the presence or level of a urodynamic parameter. In addition, the recorded information may be transmitted from external device 14 to other external devices for presentation, archival or further analysis. [0072], [0087]-[0088]), in a network system (see Figure 6), but does not directly teach sending information from a remote service infrastructure pertaining to the at least one predefined notification signal provided by the extracorporeal device, the sending includes sending the information: from the remote service infrastructure to the extracorporeal device, or from the remote service infrastructure via the patient device to the extracorporeal device.
Katra teaches a related system for monitoring and communicating with implantable devices with sensing capabilities (see at least abstract, title, [0142]), and teaches a limitation of sending information from a networked device to a patient interface for desired medical interventions based on physician direction such as a basis for potential infection of the implanted area, which reasonably teaches the claimed features (see at least Figures, 1, 23,[0134] “In some examples, the clinician may enter instructions for a medical intervention for patient 4 into an application executed by computing device 2, such as based on a status of a patient condition determined by another one of computing device(s) 2, medical device(s) 17, edge device(s) 12, server(s) 94, or any combination thereof, or based on other patient data known to the clinician. The patient condition may include an implant status, such as a potential infection at an implantation site of the implant. Computing device 2 of a user may receive the instructions, via network 10. In return, computing device 2 may display a message on a display device indicating the medical intervention message.”). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine prior art elements according to known methods to yield predictable results of displaying information for intervention to a patient in order to alert the patient to critical conditions highlighted by a physician monitoring networked data.
Response to Arguments
The examiner acknowledges applicant’s submission of amendments to the claims filed 2/25/2026.
Applicant’s arguments regarding the claim objections have been fully considered and are persuasive due to the cancelation of claims; the objections are withdrawn.
Applicant’s arguments regarding the rejections of the claims under 35 U.S.C. 112 have been fully considered and are partially persuasive due to the amendments to the claims. However, the amendments did not address all issues and/or necessitated new grounds as presented above.
Applicant’s arguments regarding the rejections of the claims in view of prior art have been fully considered but are not persuasive in view of the new grounds of rejection necessitated by the amendments to the claims.
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.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. US 2012/0296177 and US 2016/0330573 teach related systems/processes of communications with implantable and extracorporeal structures and each could additionally likely be used in making prior art rejections and should each be reviewed prior to further amendments to expedite prosecution.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL R BLOCH whose telephone number is (571)270-3252. The examiner can normally be reached M-F 11-8 EST.
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/MICHAEL R BLOCH/Primary Examiner, Art Unit 3791
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