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
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.
Claim(s) 1-2, 8 & 18 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Yoo et al. (U.S. Patent Application 2016/0339239 A1).
Claim 1: Yoo teaches –
A system [stimulation system] (Figure 18a) for treatment of an injury [treatment of…spinal cord injury] (Para 0178; intended use), the system comprising:
an implantable device [implanted device] (Para 0249 and Figure 18b, Element 110) configured to be implanted into a body [implantable neurostimulator] (Para 0249),
the implantable device [implanted device] (Figure 18b, Element 110) having
a first sensing device [sensors disposed on the housing of the device 110] (Para 0249)
a treatment device [stimulator 116 such as stimulation electrode which contains at least one contact] (Para 01249 and Figure 18b, Element 116),
the first sensing device configured to sense a first condition of the injury [processing module 58 enables the assessment of sensed data and can provide detection of events that are defined to cause delivery or adjustment of stimulation] (Para 0231 and Figure 18b, Element 58 & 110) and to
Examiner’s Note: Figure 18a and Figure 18b are disclosed as usable together. Para 0239 states, “Any of the modules of the device 50 shown in FIG. 18a, can be realized partially or fully in the physician/patient programmer 70, or EXD 72, or neurostimulation system of FIG. 18b”. Thus, referencing either Figure 18a or Figure 18b is not an improper combination of different embodiments.
generate a first signal corresponding to the first sensed condition [a sensing module…which can communicate with sensors] (Para 0249),
the treatment device configured to selectively provide treatment to the injury [processing module 58…can provide detection of events that are defined to cause delivery or adjustment of stimulation] (Para 0231 and Figure 18b, Element 58 & 116);
a wearable device [stimulation electrode] (Figure 18a, Element 88 & 89) configured to be wearable on or adjacent to an external portion of the body [electrically conductive cutaneous electrodes] (Para 0234) [two or more electrodes can be placed on the patient's back using the system of FIG. 18a] (Para 0214),
the wearable device having a second sensing device configured to sense a second condition of the body related to the injury [electrode 88 can serve as sensor when the sensing module] (Para 0236) and
to generate a second signal corresponding to the second sensed condition [sensors that are configured to measure bladder activity, bladder pressure, bladder fullness, or other characteristic related to a condition or disorder being treated] (Para 0178); and
Examiner’s Note: The Specification of the Applicant in Para 032 discloses, conditions, as blood pressure, temperature, bladder pressure, volume, motion of human limbs, etc. The first condition of the implantable device is motion [angle/position sensors] (Para 0249) and the second condition of the wearable device is electrical from the electrode [electrode 88 can serve as sensor] (Para 0236). The sensors can then generate a second signal corresponding to the second sensed condition of bladder pressure.
a control device [control module] (Figure 18a, Element 52) connected to the implantable device and connected to the wearable device [The device 50 comprises a control module 52 having a processor and control circuitry for controlling the various other modules such as the stimulation module 54 and sensing module 55] (Para 0231),
the control device configured to
receive a first signal from the implantable device [a sensing module…which can communicate with sensors] (Para 0249) and a second signal from the wearable device [electrode 88 can serve as sensor when the sensing module…during a period when sensing occurs] (Para 0236), and to
control the implantable device to selectively cause the treatment device to apply the treatment based on the first signal and/or the second signal [components to provide for control 52, stimulation 54] (Para 0249) [The processing module can aid in, for example, processing data as part of steps such as 38, 40, 42, and 258. For example, sensed data can be compared to at least one treatment criterion, and if the criterion is passed then stimulation is not changed (or is not provided), and if the treatment criterion is not passed, then stimulation is adjusted or provided, as defined by the treatment protocol] (Para 0231).
Examiner’s Note: Para 0231 provides support for the steps of Figure 17 for use with Figures 18a and 18b. Thus, referencing either Figure 17, 18a or Figure 18b is not an improper combination of different embodiments.
Claim 2/1: Yoo teaches wherein the implantable device comprises a first implantable device and a second implantable device (Figure 18a and Figure 18b).
Examiner’s Note: The claim limitation is met by pointing out that Figure 18a and 18b disclose multiple implantable devices such as: implanted device [implanted device] (Para 0249), IPC [IPC] (Para 0249) and sensors [sensors disposed on the housing of the device] (Para 0249). The claim limitation of Claim 2 does not require any further specific details beyond that there are at least two implantable devices.
Claim 8/2/1: Yoo teaches further comprising a third implantable device [IPC] (Para 0231), the third implantable device comprising an epidural spinal stimulator device [spinal stimulation] (Para 0249) [stimulate a spinal target by implantation adjacent to the associated foramen and may reside in the epidural space] (Para 0395) configured to selectively apply electrical stimulation to a spinal cord [IPC will successfully serve to enhance the stimulation of target tissue] (Para 0231).
Claim 18: Yoo teaches –
A method for monitoring and treating an injury [treatment of…spinal cord injury] (Para 0178), the method comprising:
implanting a first implantable device [implanted device] (Para 0249 and Figure 18b, Element 110) into a body [stimulate a spinal target by implantation adjacent to the associated foramen and may reside in the epidural space] (Para 0395),
the implantable device [implanted device] (Para 0249 and Figure 18b, Element 110) having
a sensor [sensors disposed on the housing of the device 110] (Para 0249) and
a treatment device [stimulator 116 such as stimulation electrode which contains at least one contact] (Para 01249 and Figure 18b, Element 116),
the sensor configured to sense a first condition of the injury [processing module 58 enables the assessment of sensed data and can provide detection of events that are defined to cause delivery or adjustment of stimulation] (Para 0231 and Figure 18b, Element 58 & 110) and
to generate a signal corresponding to the first sensed condition [a sensing module…which can communicate with sensors] (Para 0249),
the treatment device configured to selectively provide treatment to the injury [processing module 58…can provide detection of events that are defined to cause delivery or adjustment of stimulation] (Para 0231 and Figure 18b, Element 58 & 116);
attaching a first wearable device [stimulation electrode] (Figure 18a, Element 88 & 89) on an external portion of the body [electrically conductive cutaneous electrodes] (Para 0234) [two or more electrodes can be placed on the patient's back using the system of FIG. 18a] (Para 0214),
the first wearable device [stimulation electrode] (Figure 18a, Element 88 & 89) having a first sensing device configured to sense a second condition of the body related to the injury [electrode 88 can serve as sensor when the sensing module] (Para 0236);
receiving signals from the first implantable device [The device 50 comprises a control module 52 having a processor and control circuitry for controlling the various other modules such as the stimulation module 54 and sensing module 55] (Para 0231) and from the wearable device at a control device outside the body [a first stimulator conduit 84, a second stimulator conduit 86, to communicate signals to a first stimulator 88 and second stimulator 90] (Para 0234); and
controlling the first implantable device with the control device [components to provide for control 52, stimulation 54] (Para 0249) based on the signals received from the implantable device and/or from the first wearable device to selectively cause the treatment device to apply the treatment [The processing module can aid in, for example, processing data as part of steps such as 38, 40, 42, and 258. For example, sensed data can be compared to at least one treatment criterion, and if the criterion is passed then stimulation is not changed (or is not provided), and if the treatment criterion is not passed, then stimulation is adjusted or provided, as defined by the treatment protocol] (Para 0231).
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(s) 3-7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yoo et al. (U.S. Patent Application 2016/0339239 A1) as applied to claim(s) 1-2 above, and further in view of Sampath et al. (U.S. Patent Application 2020/0030099 A1).
Claim 3/2/1: Yoo teaches wherein the sensed data includes imaging data related to ultrasound (Para 0123). Yoo teaches the treatment device of the first implantable device comprises an ultrasound treatment device and/or an electrical stimulation treatment device configured to apply treatment to the injury [stimulator 116 such as stimulation electrode which contains at least one contact] (Para 01249 and Figure 18b, Element 116).
Yoo fails to teach wherein the first implantable device comprises an ultrasound imaging device. However, Sampath teaches wherein the first implantable device comprises an ultrasound imaging device configured to generate a signal corresponding to the injury after the implantable device is implanted into the body [The ultrasound compatible inner disc further provides the practitioner with the ability to image the brain during drainage of the cerebrospinal fluid combined with the ability to monitor intracranial pressure with the ICP monitor] (Para 0057) in order to allow for the continuous, uninterrupted, simultaneous monitoring at the patient's bedside (Abstract)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the first implantable device of Yoo to include the ultrasound imaging device of Sampath in order to allow for the continuous, uninterrupted, simultaneous monitoring at the patient's bedside (Abstract).
Claim 4/3/2/1: Yoo teaches wherein the device [sensors disposed on the housing of the device 110] (Para 0249) is configured to send the first signal to the control device [control module] (Figure 18a, Element 52), and the control device [control module] (Figure 18a, Element 52) is configured to control the ultrasound treatment device and/or the electrical stimulation treatment device to selectively apply the treatment to the injury [components to provide for control 52, stimulation 54] (Para 0249) [The processing module can aid in, for example, processing data as part of steps such as 38, 40, 42, and 258. For example, sensed data can be compared to at least one treatment criterion, and if the criterion is passed then stimulation is not changed (or is not provided), and if the treatment criterion is not passed, then stimulation is adjusted or provided, as defined by the treatment protocol] (Para 0231).
Yoo fails to teach the ultrasound imaging device. However, Sampath teaches wherein the ultrasound imaging device is configured to control [used to image and monitor congenital or acquired hydrocephalus at the bedside, in particular, allowing the treating physician the capability of evaluating cerebral spinal fluid diversion] (Para 0054) in order to allow for the continuous, uninterrupted, simultaneous monitoring at the patient's bedside (Abstract)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Yoo to include the ultrasound imaging device of Sampath in order to allow for the continuous, uninterrupted, simultaneous monitoring at the patient's bedside (Abstract).
Claim 5/2/1: Yoo teaches wherein the second implantable device comprises a plurality of sensor devices [sensors disposed on the housing of the device 110] (Para 0249)
Examiner’s Note: Yoo teaches that there are additional sensors and stimulators but those elements are not shown in order to not clutter the Figures in the Drawings [Additional sensors and stimulators are not shown in addition to sensor/stimulator electrodes 88,89 to avoid cluttering of the figure] (Para 0237)
Although Yoo teaches a catheter device to drain the bladder (Para 0201). Yoo fails to teach a catheter device configured to selectively drain spinal fluid from the body. However, Sampath teaches a catheter device configured to selectively drain spinal fluid from the body [external ventricular drainage catheter acts as a pathway to drain cerebral spinal fluid from the patient's ventricles to relieve intracranial pressure. EVD catheters are connected to an external drainage and monitoring system] (Para 0057) in order to allow for the continuous, uninterrupted, simultaneous monitoring at the patient's bedside (Abstract)
Examiner’s Note: Although the claim limitation is directed to an implantable device and the catheter of Sampath is described as external, catheters for spinal drainage are both external and internal in order for the drainage of the spinal fluid from internal to external. Thus, the catheter of Sampath reads on the claim limitation.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Yoo to include the catheter of Sampath in order to allow for the continuous, uninterrupted, simultaneous monitoring at the patient's bedside (Abstract).
Claim 6/5/2/1: Yoo teaches the sensor devices [sensors disposed on the housing of the device 110] (Para 0249) are configured to generate signals [components to provide for control 52, stimulation 54] (Para 0249) indicative of the sensed conditions (Para 0231) and to send the signals to the control device [control module] (Figure 18a, Element 52).
Yoo fails to teach all the claimed sensors. However, Sampath teaches wherein the plurality of sensor devices comprise a temperature sensor [temperature probe] (Para 0058), a pressure sensor [pressure monitors] (Claim 7-8) and a biomarker sensor [chemical analysis] (Claim 8) configured to sense conditions including temperature (Para 0058), pressure [pressure monitors] (Claim 7-8) and biomarker conditions [chemical analysis] (Claim 8) in order to allow for the continuous, uninterrupted, simultaneous monitoring at the patient's bedside (Abstract)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Yoo to include the sensors of Sampath in order to allow for the continuous, uninterrupted, simultaneous monitoring at the patient's bedside (Abstract).
Claim 7/6/5/2/1: Although Yoo teaches a catheter device to drain the bladder (Para 0201). Yoo fails to teach wherein the control device is configured to control the catheter device to selectively drain spinal fluid from the body based on the signals [external ventricular drainage catheter acts as a pathway to drain cerebral spinal fluid from the patient's ventricles to relieve intracranial pressure. EVD catheters are connected to an external drainage and monitoring system] (Para 0057) received from the temperature sensor [temperature probe] (Para 0058), the pressure sensor [pressure monitors] (Claim 7-8) and/or the biomarker sensor [chemical analysis] (Claim 8) in order to allow for the continuous, uninterrupted, simultaneous monitoring at the patient's bedside (Abstract)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Yoo to include the catheter of Sampath in order to allow for the continuous, uninterrupted, simultaneous monitoring at the patient's bedside (Abstract).
Claim(s) 9-11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yoo et al. (U.S. Patent Application 2016/0339239 A1) as applied to claim(s) 1 above, and further in view of Bar-Yoseph et al. (U.S. Patent Application 2015/0142074 A1).
Claim 9/1: Yoo teaches wherein the device comprises a first device [sensed physiological data including…blood pressure] (Para 0276), a second device [bladder pressure which is sensed by a sensor implanted] (Para 0210) and a third device [accelerometers, angle/position sensors] (Para 0249).
Yoo fails to teach wearable. However, Bar-Yoseph teaches wherein the wearable device comprises a first wearable device [blood pressure can be measured by a pressure sensor…measured externally as known in the art] (Para 0524), a second wearable device [Bladder pressure can be measured by…extravesical pressure sensor…the pressure sensor is located on the outside of the body part] (Para 0524) and a third wearable device [electrode][EMG][electrical recordings of muscle twitching] (Para 0524) in order to allow for stimulation and/or control of body physiology are used as a long term treatment with a goal of treating, preventing degradation and/or maintaining a patient (Para 0328)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the devices of Yoo to include the wearable devices of Bar-Yosef in order to allow for stimulation and/or control of body physiology are used as a long term treatment with a goal of treating, preventing degradation and/or maintaining a patient (Para 0328).
Claim 10/9/1: Yoo teaches wherein the device comprises a first device [sensed physiological data including…blood pressure] (Para 0276), a second device [bladder pressure which is sensed by a sensor implanted] (Para 0210) and a third device [accelerometers, angle/position sensors] (Para 0249).
Yoo fails to teach wearable. However, Bar-Yoseph teaches wherein the first wearable device comprises a blood pressure sensor configured to measure a blood pressure [blood pressure can be measured by a pressure sensor… measured externally as known in the art] (Para 0524), the second wearable device comprises a bladder sensor device configured to sense a volume of a bladder [Bladder pressure can be measured by…extravesical pressure sensor…the pressure sensor is located on the outside of the body part] (Para 0524) and the third wearable device comprises an electromyograph (EMG) sensor [EMG] (Para 0524) configured to monitor motion of a limb [sensor may indicate movement] (Para 0340) in order to allow for stimulation and/or control of body physiology are used as a long term treatment with a goal of treating, preventing degradation and/or maintaining a patient (Para 0328)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the devices of Yoo to include the wearable devices of Bar-Yosef in order to allow for stimulation and/or control of body physiology are used as a long term treatment with a goal of treating, preventing degradation and/or maintaining a patient (Para 0328).
Claim 11/10/9/1: Yoo teaches wherein the sensor includes a plurality [sensors disposed on the housing of the device 110] (Para 0249) of accelerometers [sensing module 55 which may contain, for example, accelerometers] (Para 0340) configured to sense a motion of a limb of the human [motion data, etc indicating…that the patient is laying down] (Para 0211) and to generate a signal corresponding to the sensed motion [The device 50 comprises a control module 52 having a processor and control circuitry for controlling the various other modules such as the stimulation module 54 and sensing module 55] (Para 0231), and to send the signal corresponding to the sensed motion to the control device [processing module 58 enables the assessment of sensed data and can provide detection of events that are defined to cause delivery or adjustment of stimulation] (Para 0231 and Figure 18b, Element 58 & 110).
Yoo fails to teach the EMG sensor. However, Bar-Yoseph teaches the EMG sensor [EMG] (Para 0524) in order to allow for stimulation and/or control of body physiology are used as a long term treatment with a goal of treating, preventing degradation and/or maintaining a patient (Para 0328)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the sensors of Yoo to include the EMG sensor of Bar-Yosef in order to allow for stimulation and/or control of body physiology are used as a long term treatment with a goal of treating, preventing degradation and/or maintaining a patient (Para 0328).
Claim(s) 12 & 14-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yoo et al. (U.S. Patent Application 2016/0339239 A1) and further in view of Sampath et al. (U.S. Patent Application 2020/0030099 A1).
Claim 12: Yoo teaches –
A system [stimulation system] (Figure 18a) for monitoring and treatment of a spinal cord injury [treatment of…spinal cord injury] (Para 0178; intended use), comprising:
a first implantable device [implanted device] (Para 0249 and Figure 18b, Element 110) configured to be implantable into a body adjacent the spinal cord injury [stimulate a spinal target by implantation adjacent to the associated foramen and may reside in the epidural space] (Para 0395),
the first implantable device including a device configured to monitor the spinal cord [processing module 58 enables the assessment of sensed data and can provide detection of events that are defined to cause delivery or adjustment of stimulation] (Para 0231 and Figure 18b, Element 58 & 110), and including
a treatment device [implantable neurostimulator] (Para 0249) configured to selectively treat the injury [The processing module can aid in, for example, processing data as part of steps such as 38, 40, 42, and 258. For example, sensed data can be compared to at least one treatment criterion, and if the criterion is passed then stimulation is not changed (or is not provided), and if the treatment criterion is not passed, then stimulation is adjusted or provided, as defined by the treatment protocol] (Para 0231);
a wearable device [stimulation electrode] (Figure 18a, Element 88 & 89) configured to be wearable on or adjacent to an external portion of the body [electrically conductive cutaneous electrodes] (Para 0234) [two or more electrodes can be placed on the patient's back using the system of FIG. 18a] (Para 0214),
the wearable device including a sensor configured to sense a condition related to the injury [electrode 88 can serve as sensor when the sensing module] (Para 0236); and
Examiner’s Note: The Specification of the Applicant in Para 032 discloses, conditions, as blood pressure, temperature, bladder pressure, volume, motion of human limbs, etc. The first condition of the implantable device is motion [angle/position sensors] (Para 0249) and the second condition of the wearable device is electrical from the electrode [electrode 88 can serve as sensor] (Para 0236).
a control device connected to the first implantable device [implanted device 110 will have ports 112 for securely connecting to an electrical conduit 114 (which may have an intervening connection member 115 to connect various types of implantable electrode conduits and sensors) and for communicating stimulation pulse waveforms] (Para 0249),
connected to the second implantable device [The device 50 comprises a control module 52 having a processor and control circuitry for controlling the various other modules such as the stimulation module 54 and sensing module 55] (Para 0231), and
connected [a first stimulator conduit 84, a second stimulator conduit 86, to communicate signals to a first stimulator 88 and second stimulator 90] (Para 0234) to the wearable device [stimulation electrode] (Figure 18a, Element 88 & 89),
the control device configured to receive data from the first implantable device [processing module 58 enables the assessment of sensed data and can provide detection of events that are defined to cause delivery or adjustment of stimulation] (Para 0231 and Figure 18b, Element 58 & 110),
to receive a signal from each of the sensor devices of the second implantable device [The device 50 comprises a control module 52 having a processor and control circuitry for controlling the various other modules such as the stimulation module 54 and sensing module 55] (Para 0231), and
to receive a signal corresponding to the sensed condition from the wearable device [a first stimulator conduit 84, a second stimulator conduit 86, to communicate signals to a first stimulator 88 and second stimulator 90] (Para 0234), and
configured to control [components to provide for control 52, stimulation 54] (Para 0249) the first implantable device to cause the treatment device to selectively apply the treatment based on the data [The processing module can aid in, for example, processing data as part of steps such as 38, 40, 42, and 258. For example, sensed data can be compared to at least one treatment criterion, and if the criterion is passed then stimulation is not changed (or is not provided), and if the treatment criterion is not passed, then stimulation is adjusted or provided, as defined by the treatment protocol] (Para 0231) of the spinal cord [treatment of…spinal cord injury] (Para 0178), and
a plurality of sensor devices configured to sense conditions of the body [sensors disposed on the housing of the device] (Para 0249)
Yoo fails to teach wherein the first implantable device comprises an ultrasound imaging device. However, Sampath teaches –
a first implantable device configured to be implantable into a body adjacent the spinal cord injury, the first implantable device including an imaging device configured to create an image of the spinal cord [The ultrasound compatible inner disc further provides the practitioner with the ability to image the brain during drainage of the cerebrospinal fluid combined with the ability to monitor intracranial pressure with the ICP monitor] (Para 0057)
receive the image from the first implantable device and cause to selectively apply the treatment based on the image of the spinal cord [used to image and monitor congenital or acquired hydrocephalus at the bedside, in particular, allowing the treating physician the capability of evaluating cerebral spinal fluid diversion] (Para 0054) in order to allow for the continuous, uninterrupted, simultaneous monitoring at the patient's bedside (Abstract)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the first implantable device of Yoo to include the ultrasound imaging device of Sampath in order to allow for the continuous, uninterrupted, simultaneous monitoring at the patient's bedside (Abstract).
Yoo fails to teach a catheter for draining spinal fluid. However, Sampath teaches –
a catheter device configured to selectively drain spinal fluid from the body [external ventricular drainage catheter acts as a pathway to drain cerebral spinal fluid from the patient's ventricles to relieve intracranial pressure. EVD catheters are connected to an external drainage and monitoring system] (Para 0057) and;
to control the device to selectively cause the catheter device to drain the spinal fluid based on the sensed conditions of the body [external ventricular drainage catheter acts as a pathway to drain cerebral spinal fluid from the patient's ventricles to relieve intracranial pressure. EVD catheters are connected to an external drainage and monitoring system] (Para 0057) in order to allow for the continuous, uninterrupted, simultaneous monitoring at the patient's bedside (Abstract)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Yoo to include the catheter of Sampath in order to allow for the continuous, uninterrupted, simultaneous monitoring at the patient's bedside (Abstract).
Claim 14/12: Yoo teaches wherein the sensed data includes imaging data related to ultrasound (Para 0123). Yoo teaches the treatment device is an ultrasound treatment device and/or an electrical stimulation treatment device configured to apply treatment to the injury [stimulator 116 such as stimulation electrode which contains at least one contact] (Para 01249 and Figure 18b, Element 116).
Yoo fails to teach wherein the imaging device is an ultrasound imaging device. However, Sampath teaches wherein the imaging device is an ultrasound imaging device [The ultrasound compatible inner disc further provides the practitioner with the ability to image the brain during drainage of the cerebrospinal fluid combined with the ability to monitor intracranial pressure with the ICP monitor] (Para 0057) in order to allow for the continuous, uninterrupted, simultaneous monitoring at the patient's bedside (Abstract)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the first implantable device of Yoo to include the ultrasound imaging device of Sampath in order to allow for the continuous, uninterrupted, simultaneous monitoring at the patient's bedside (Abstract).
Claim 15/12: Yoo teaches the sensor devices [sensors disposed on the housing of the device 110] (Para 0249) are configured to generate signals [components to provide for control 52, stimulation 54] (Para 0249) indicative of the sensed conditions (Para 0231) and to send the signals to the control device [control module] (Figure 18a, Element 52) .
Yoo fails to teach all the claimed sensors. However, Sampath teaches wherein the plurality of sensor devices comprise a temperature sensor [temperature probe] (Para 0058), a pressure sensor [pressure monitors] (Claim 7-8) and a biomarker sensor [chemical analysis] (Claim 8) configured to sense conditions including temperature (Para 0058), pressure [pressure monitors] (Claim 7-8) and biomarker conditions [chemical analysis] (Claim 8) in order to allow for the continuous, uninterrupted, simultaneous monitoring at the patient's bedside (Abstract)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Yoo to include the sensors of Sampath in order to allow for the continuous, uninterrupted, simultaneous monitoring at the patient's bedside (Abstract).
Claim(s) 16-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yoo et al. (U.S. Patent Application 2016/0339239 A1) and Sampath et al. (U.S. Patent Application 2020/0030099 A1) as applied to claim 12 above, and further in view of Bar-Yoseph et al. (U.S. Patent Application 2015/0142074 A1).
Claim 16/12: Yoo teaches wherein the device comprises a first device [sensed physiological data including…blood pressure] (Para 0276), a second device [bladder pressure which is sensed by a sensor implanted] (Para 0210) and a third device [accelerometers, angle/position sensors] (Para 0249).
Yoo and Sampath fails to teach the details of the wearables. However, Bar-Yoseph teaches wherein the wearable device comprises a first wearable device [blood pressure can be measured by a pressure sensor…measured externally as known in the art] (Para 0524), a second wearable device [Bladder pressure can be measured by…extravesical pressure sensor…the pressure sensor is located on the outside of the body part] (Para 0524) and a third wearable device [electrode][EMG][electrical recordings of muscle twitching] (Para 0524 and shown in Figure 43, Element 200) in order to allow for stimulation and/or control of body physiology are used as a long term treatment with a goal of treating, preventing degradation and/or maintaining a patient (Para 0328)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the devices of Yoo and Sampath to include the wearable devices of Bar-Yosef in order to allow for stimulation and/or control of body physiology are used as a long term treatment with a goal of treating, preventing degradation and/or maintaining a patient (Para 0328).
Claim 17/16/12: Yoo teaches wherein the device comprises a first device [sensed physiological data including…blood pressure] (Para 0276), a second device [bladder pressure which is sensed by a sensor implanted] (Para 0210) and a third device [accelerometers, angle/position sensors] (Para 0249).
Yoo and Sampath fails to teach the details of the wearables. However, Bar-Yoseph teaches wherein the first wearable device comprises a blood pressure sensor configured to measure a blood pressure [blood pressure can be measured by a pressure sensor… measured externally as known in the art] (Para 0524), the second wearable device comprises a bladder sensor device configured to sense a volume of a bladder [Bladder pressure can be measured by…extravesical pressure sensor…the pressure sensor is located on the outside of the body part] (Para 0524) and the third wearable device comprises an electromyograph (EMG) sensor [EMG] (Para 0524) configured to monitor motion of a limb [sensor may indicate movement] (Para 0340) in order to allow for stimulation and/or control of body physiology are used as a long term treatment with a goal of treating, preventing degradation and/or maintaining a patient (Para 0328)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the devices of Yoo and Sampath to include the wearable devices of Bar-Yosef in order to allow for stimulation and/or control of body physiology are used as a long term treatment with a goal of treating, preventing degradation and/or maintaining a patient (Para 0328)
Claim(s) 19-21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yoo et al. (U.S. Patent Application 2016/0339239 A1) as applied to claim(s) 18 above, and further in view of Sampath et al. (U.S. Patent Application 2020/0030099 A1).
Claim 19/18: Yoo teaches wherein the injury is a spinal cord injury [treatment of…spinal cord injury] (Para 0178), and the first sensing device is an ultrasound device (Para 0123) configured to generate sensed data of the injury [stimulator 116 such as stimulation electrode which contains at least one contact] (Para 01249 and Figure 18b, Element 116).
Yoo fails to teach wherein the first sensing device is an ultrasound imaging device configured to generate an image of the injury. However, Sampath teaches wherein the first sensing device is an ultrasound imaging device configured to generate an image of the injury [The ultrasound compatible inner disc further provides the practitioner with the ability to image the brain during drainage of the cerebrospinal fluid combined with the ability to monitor intracranial pressure with the ICP monitor] (Para 0057) in order to allow for the continuous, uninterrupted, simultaneous monitoring at the patient's bedside (Abstract)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the first implantable device of Yoo to include the ultrasound imaging device of Sampath in order to allow for the continuous, uninterrupted, simultaneous monitoring at the patient's bedside (Abstract).
Claim 20/19/18: Yoo teaches wherein the treatment device of the first implantable device comprises an ultrasound treatment device and/or an electrical stimulation treatment device configured to apply treatment to the injury [stimulator 116 such as stimulation electrode which contains at least one contact] (Para 01249 and Figure 18b, Element 116) [components to provide for control 52, stimulation 54] (Para 0249) [The processing module can aid in, for example, processing data as part of steps such as 38, 40, 42, and 258. For example, sensed data can be compared to at least one treatment criterion, and if the criterion is passed then stimulation is not changed (or is not provided), and if the treatment criterion is not passed, then stimulation is adjusted or provided, as defined by the treatment protocol] (Para 0231).
Claim 21/19/18: Yoo teaches further comprising:
implanting a second implantable device [sensors disposed on the housing of the device 110] (Para 0249) into the body [implanted device] (Figure 18b, Element 110),
the second implantable device [sensors disposed on the housing of the device 110] (Para 0249) comprising
a plurality of sensor devices [sensors disposed on the housing of the device 110] (Para 0249)
receiving signals at the control device [control module] (Figure 18a, Element 52) from the plurality of sensor devices [components to provide for control 52, stimulation 54] (Para 0249); and
controlling the control device based on the signals from the plurality of sensor devices [components to provide for control 52, stimulation 54] (Para 0249) [The processing module can aid in, for example, processing data as part of steps such as 38, 40, 42, and 258. For example, sensed data can be compared to at least one treatment criterion, and if the criterion is passed then stimulation is not changed (or is not provided), and if the treatment criterion is not passed, then stimulation is adjusted or provided, as defined by the treatment protocol] (Para 0231)
Although Yoo teaches a catheter device to drain the bladder (Para 0201). Yoo fails to teach a catheter device configured to selectively drain spinal fluid from the body. However, Sampath teaches a catheter device configured to selectively drain spinal fluid from the body [external ventricular drainage catheter acts as a pathway to drain cerebral spinal fluid from the patient's ventricles to relieve intracranial pressure. EVD catheters are connected to an external drainage and monitoring system] (Para 0057) in order to allow for the continuous, uninterrupted, simultaneous monitoring at the patient's bedside (Abstract)
Examiner’s Note: Although the claim limitation is directed to an implantable device and the catheter of Sampath is described as external, catheters for spinal drainage are both external and internal in order for the drainage of the spinal fluid from internal to external. Thus, the catheter of Sampath reads on the claim limitation.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Yoo to include the catheter of Sampath in order to allow for the continuous, uninterrupted, simultaneous monitoring at the patient's bedside (Abstract).
Although Yoo teaches a catheter device to drain the bladder (Para 0201). Yoo fails to teach controlling the catheter device with the control device to selectively drain spinal fluid from the body. However, Sampath teaches controlling the catheter device with the control device to selectively drain spinal fluid from the body [external ventricular drainage catheter acts as a pathway to drain cerebral spinal fluid from the patient's ventricles to relieve intracranial pressure. EVD catheters are connected to an external drainage and monitoring system] (Para 0057) in order to allow for the continuous, uninterrupted, simultaneous monitoring at the patient's bedside (Abstract)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Yoo to include the catheter of Sampath in order to allow for the continuous, uninterrupted, simultaneous monitoring at the patient's bedside (Abstract).
Claim(s) 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yoo et al. (U.S. Patent Application 2016/0339239 A1) and Sampath et al. (U.S. Patent Application 2020/0030099 A1) as applied to claim(s) 19-21 above, and further in view of Bar-Yoseph et al. (U.S. Patent Application 2015/0142074 A1).
Claim 22/21/19/18: Yoo teaches further comprising:
attaching a second device on an external portion of the body,
the second device having a second sensing device configured to sense a second condition of the body related to the injury [bladder pressure which is sensed by a sensor implanted] (Para 0210);
attaching a third device on a portion of the body [accelerometers, angle/position sensors] (Para 0249),
the device having a third sensing device configured to sense a second condition of the body related to the injury [motion data, etc indicating, for example, that the patient is laying down] (Para 0211); and
receiving signals from the second device and from the third device at the control device [components to provide for control 52, stimulation 54] (Para 0249) [The processing module can aid in, for example, processing data as part of steps such as 38, 40, 42, and 258. For example, sensed data can be compared to at least one treatment criterion, and if the criterion is passed then stimulation is not changed (or is not provided), and if the treatment criterion is not passed, then stimulation is adjusted or provided, as defined by the treatment protocol] (Para 0231)
Yoo and Sampath fails to teach the details of the wearables and attaching a third device on an external portion of the body. However, Bar-Yoseph teaches wearable devices [blood pressure can be measured by a pressure sensor…measured externally as known in the art] (Para 0524) [Bladder pressure can be measured by…extravesical pressure sensor…the pressure sensor is located on the outside of the body part] (Para 0524) and attaching a third device [EMG] (Para 0524) on an external portion of the body (as shown in Figure 43, Element 200) in order to allow for stimulation and/or control of body physiology are used as a long term treatment with a goal of treating, preventing degradation and/or maintaining a patient (Para 0328)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the sensors of Yoo and Sampath to include the EMG sensor of Bar-Yosef in order to allow for stimulation and/or control of body physiology are used as a long term treatment with a goal of treating, preventing degradation and/or maintaining a patient (Para 0328).
Response to Arguments
Applicant’s arguments, see Page 7, filed 05/11/2026, with respect to 35 USC § 112, second paragraph rejection have been fully considered and are persuasive. The 35 USC § 112, second paragraph rejection of the claims has been withdrawn.
Applicant's arguments filed 05/11/2026 have been fully considered but they are not persuasive. The Applicant submitted arguments that the electrodes provide therapy for chronic disease such as Parkinson’s and no for treatment of an injury.
First, the Examiner contends that the claim limitation of A system for treatment of an injury is intended use. The system has no capability to determine the treatment is being applied to an injury nor does the system have any diagnostic capabilities to verify that. The claim is directed to a system comprising a control device to selectively cause the treatment device to apply the treatment. The patient is not required in the claim for the treatment to be applied to. Second, Para 0178 discloses a stimulation protocol for the treatment of spinal cord injury. The Applicant failed to address the argument with respect to the cited Para 0178.
The Applicant, on Page 9, argues that Yoo does not teach a wearable device having a sensing device configured to sensor either a first or the second condition of the body related to the injury and to generate a second signal corresponding to the second sensed condition. The Examiner respectfully disagrees. The Applicant acknowledged that Yoo does teach that the electrode of Yoo can serve as both stimulator and sensor. Yoo further describes what the capabilities of the sensor of Yoo is used for. In Para 0237, Yoo teaches:
sensors that are configured to measure bladder activity, bladder pressure, bladder fullness, or other characteristic related to a condition or disorder being treated
The above paragraph makes it clear that the electrodes 88, 90 of Yoo serve as both stimulator and sensor and the sensors are configured to sense a condition of the body such as bladder pressure. The argument is unconvincing.
The Applicant, on Page 9, states that Yoo’s disclosure teaches that electrode 88 can serve as a sensor to detect the signal from electrode 90. The argument is unclear. How can electrodes 88 & 90 serving as both stimulators and sensors detect signals from each other? In Figure 18a, the electrodes 88 and 90 are not directly connected together. Rather electrodes 88 and 90 are connected through the control circuitry of the device 50 and signals are sent from each electrode to the control circuitry. The argument is unconvincing as it is not clear how electrode 88 can detect the signal from electrode 90 and the Applicant fails to point out support for this arrangement in the disclosure of Yoo. The Applicant is stating terms such as “cutaneous electrodes”, “different moments in time” and “conditional disclosure”. However there is no discernible arguments being made. Is the Applicant arguing that the cutaneous electrodes are not external or wearable? Is the Applicant arguing that the wearable device operates in different times as a sensor and stimulator and thus fails to read on the claim limitation? The following paragraph just summarizes the claim limitations but fails to provide any substantive argument as to why Yoo fails to teach the claim limitation. The Examiner is confused as to the arguments being presented and the arguments are being addressed as best understood by the Examiner.
At the bottom on Page 9, the Applicant notes Yoo is a primary reference. Then proceeds to argue that the primary reference is non-analogous art. The Examiner respectfully disagrees. Previously discussed above, the Examiner pointed out Para 0178 and the disclosure of a stimulation protocol for the treatment of spinal cord injury. The Examiner contends that Yoo teaches a system directed to monitoring and treating an injury using implantable and/pr wearable sensing devices as demonstrated in the rejection above. The argument is unconvincing.
The Applicant on Page 11 submitted arguments that Sampath is directed to a cranial prothesis and not an implantable spinal cord injury device. The Examiner contends that Sampath is analogous art because it addresses the problem of injury monitoring of cerebral spinal fluid diversion (Para 0054 of Sampath). The Examiner notes that the Applicant acknowledges that the problem being addressed by the invention of the Applicant is monitor injury-related conditions (Page 10 of the Remarks of the Applicant filed 05/1/2026). The argument is unconvincing.
The Applicant submitted arguments that Sampath fails to teach an implantable ultrasound imaging device. However, the combination was regarding the replacement of electrode monitoring for ultrasound monitoring. Replacing the ultrasound monitoring of Sampath for the electrode monitoring of Yoo would have been obvious as the ultrasound monitoring as taught by Sampath would be able to perform the sensing and treating via electrode or ultrasound transducer. The Examiner contends that one of ordinary skill in the art would understand the electrode monitoring and treatment of Yoo can similarly and obviously be performed by ultrasound as taught by Sampath. The argument is unconvincing.
The Applicant submitted arguments on Page 13 that Sampath is non-analogous art. The Examiner contends that Sampath is reasonably pertinent to the problem faced by the inventor (monitor and treatment of an injury). Replacing the ultrasound monitoring of Sampath for the electrode monitoring of Yoo would have been obvious as the ultrasound monitoring as taught by Sampath would be able to perform the sensing and treating via electrode or ultrasound transducer. The Examiner contends that one of ordinary skill in the art would understand the electrode monitoring and treatment of Yoo can similarly and obviously be performed by ultrasound as taught by Sampath. The argument is unconvincing.
The rejection is deemed proper and is hereby maintained.
Conclusion
THIS ACTION IS MADE FINAL. 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HELENE C BOR whose telephone number is (571)272-2947. The examiner can normally be reached Mon - Fri 10:30 - 6:30.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Christopher Koharski can be reached at (571) 272-7230. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/Helene Bor/Examiner, Art Unit 3797
/JOSEPH M SANTOS RODRIGUEZ/Primary Examiner, Art Unit 3797
Prosecution Insights