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) 2-3, 7-9, 12-13, and 15-16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Rosenbluth et al (US 2015/0321000) hereinafter Rosenbluth.
Regarding claim 2, Rosenbluth discloses a wearable device (Figs. 14A-E) for transcutaneous stimulation of a first afferent lower extremity nerve for treating urinary symptoms in a patient, the device comprising:
a controller ([0130] Decision Unit 702);
a first peripheral nerve effector ([0127] effector 730), comprising at least one stimulation electrode configured to be positioned to transcutaneously modulate a first afferent lower extremity nerve ([0135] Electrical effectors can include an electrode, an electrode pair, an array of electrodes or any device capable of delivering an electrical stimulation to a desired location); and
a stimulator ([0127] controls module 740) configured to deliver a first electrical stimulus to the first afferent lower extremity nerve through the first peripheral nerve effector to reduce urinary symptoms by modifying a brain or spinal cord autonomic feedback loop relating to bladder function ([0139] control unit 740 which could apply electrical stimulation via the electrodes),
wherein the device is not configured for implantation within the patient ([0161] the system 700 from FIG. 7 can be non-invasive),
wherein the first electrical stimulus comprises burst stimulation ([0061] first electrical stimulus as a plurality of bursts of electrical stimulation; [0147] As shown in FIG. 10B, bursts of high-frequency stimulation may be timed).
Regarding claim 3, Rosenbluth discloses at least one biomedical sensor or data input source ([0127] sensor 780) configured to provide feedback information ([0127] a sensor 780 connected to the processor 797 which may detect information of predefined parameters and transmits said parameter information to the processor 797);
wherein the controller ([0130] decision unit 702) comprises a processor and a memory (Fig. 7D: Decision unit 702 contains processor 797 and memory 770) for receiving the feedback information from the at least one biomedical sensor ([0127] The device may include a data storage unit 770 connected to the sensor 780 and processor 797) that, when executed by the processor, cause the device to:
adjust one or more parameters of the first electrical stimulus based at least in part on the feedback information ([0062-0063] memory storing instructions that, when executed by the processor, further cause the decision unit to set parameters of the first electrical stimulus).
Regarding claim 7, Rosenbluth discloses wherein the first electrical stimulus comprises a stimulation parameter modulated within a range from a first lower predetermined value to a second higher predetermined value ([0140] digitally stored protocols cycle through various stimulation parameters), wherein the stimulation parameter is selected from the group consisting of pulse width, frequency, and amplitude ([0140] parameters are selected from a group including but not limited to frequency, intensity, pulse width or pulse duration, and overall duration and outputs preferably have a power limit set by the maximum output voltage; Fig. 10B).
Regarding claim 8, Rosenbluth discloses wherein the first electrical stimulus is stimulatory to the first afferent lower extremity nerve ([0116] The effect of delivery of the signal to the neural tissue may be excitatory or inhibitory).
Regarding claim 9, Rosenbluth discloses wherein the first electrical stimulus is inhibitory to the first afferent lower extremity nerve ([0116] The effect of delivery of the signal to the neural tissue may be excitatory or inhibitory).
Regarding claim 12, Rosenbluth discloses wherein the feedback information comprises real-time feedback information ([0212] processor 797 can also receive information from the sensors 780 and process that information on board and adjust the stimulation accordingly).
Regarding claim 13, Rosenbluth discloses wherein the feedback information comprises autonomic nervous system activity of the patient ([0133] sensor units 780, sensing motion, temperature, etc.).
Regarding claim 15, Rosenbluth discloses wherein the feedback information comprises information relating to nocturia events of the patient ([0132] sensor 780 could include motion sensors including accelerometers).
Regarding claim 16, Rosenbluth discloses wherein the feedback information comprises information relating to patient sleep state ([0178] sensors may also be used to determine activities, such as to distinguish involuntary movements (e.g. tremor) from voluntary movements (e.g. drinking, writing) or the presence and absence of the tremor relative to the time of day or other detected activities such as sleep/wake cycles).
Claim(s) 17 and 19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Moffitt et al (US 2016/0082253) hereinafter Moffitt.
Regarding claim 17, Moffitt discloses A wearable system for treating urinary symptoms in a patient, the system comprising:
a first controller ([0036] control module 102a) and a second controller ([0036] control module 102b) configured to operably communicate with each other, the first controller and the second controller not in physical communication with each other ([0043] separate control modules (see e.g., FIG. 1C) in communication with one another);
a first peripheral nerve effector ([0038] electrode set 132), comprising at least one stimulation electrode ([0038] electrodes 132a-b) configured to be positioned to transcutaneously modulate a first afferent nerve pathway associated with bladder function ([0039] electrodes are formed as conductive pads designed for temporarily adhering to patient skin during a stimulation procedure); and
a second peripheral nerve effector ([0038] electrode set 134), comprising at least one stimulation electrode ([0038] electrodes 134a-b) configured to be positioned to transcutaneously modulate the first afferent nerve pathway associated with bladder function ([0039] electrodes are formed as conductive pads designed for temporarily adhering to patient skin during a stimulation procedure);
at least one input source ([0084] sensor 152) configured to provide feedback information ([0092] sensor 152 and processing unit 162 may also be in communication with one another);
a stimulator ([0092] programming unit 508) configured to deliver a first electrical stimulus to the first afferent nerve pathway through the first peripheral nerve effector to reduce urinary symptoms by modifying a first brain or spinal cord autonomic feedback loop relating to bladder function ([0092] programming unit 508 may be utilized to control and adjust stimulation);
and deliver a second electrical stimulus to the first afferent nerve pathway through the second peripheral nerve effector to reduce urinary symptoms by modifying the first brain or spinal cord autonomic feedback loop relating to bladder function ([0092] programming unit 508 may be utilized to control and adjust stimulation).
Regarding claim 19, Moffitt discloses wherein the feedback information comprises autonomic nervous system activity of the patient ([0084] a sensor 152 that senses a pain indicator, such as frequency shifts in the theta band).
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.
Claim(s) 4-6 are rejected under 35 U.S.C. 103 as being unpatentable over Rosenbluth (US 2015/0321000) in view of Mishelevich (US 2017/0246481).
Regarding claim 4, Rosenbluth discloses the system of claim 2 as discussed above, but fails to disclose wherein the burst stimulation comprises alpha, delta, or theta burst stimulation. However, Mishelevich discloses wherein the burst stimulation comprises alpha, delta, or theta burst stimulation ([0570] Theta-Burst Stimulation (TBS) that consists of short bursts (e.g., three) of high-frequency pulses impulses repeated). It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Rosenbluth with the burst stimulation comprises alpha, delta, or theta burst stimulation as taught by Mishelevich. Such a modification would provide the predictable results of treating clinical conditions using superficial neuromodulation (Mishelevich, Abstract).
Regarding claim 5, Rosenbluth discloses the system of claim 2 as discussed above, but fails to disclose wherein the burst stimulation comprises theta burst stimulation. However, Mishelevich discloses wherein the burst stimulation comprises theta burst stimulation ([0570] Theta-Burst Stimulation (TBS) that consists of short bursts (e.g., three) of high-frequency pulses impulses repeated). It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Rosenbluth with the burst stimulation comprises theta burst stimulation as taught by Mishelevich. Such a modification would provide the predictable results of treating clinical conditions using superficial neuromodulation (Mishelevich, Abstract).
Regarding claim 6, Rosenbluth discloses the system of claim 2 as discussed above, but fails to disclose wherein the burst stimulation comprises intermittent, intermediate, or continuous theta burst stimulation. However, Mishelevich discloses wherein the burst stimulation comprises intermittent, intermediate, or continuous theta burst stimulation ([0570] Theta-Burst Stimulation (TBS) that consists of short bursts (e.g., three) of high-frequency pulses impulses repeated). It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Rosenbluth with the burst stimulation comprises intermittent, intermediate, or continuous theta burst stimulation as taught by Mishelevich. Such a modification would provide the predictable results of treating clinical conditions using superficial neuromodulation (Mishelevich, Abstract).
Claim(s) 10 is rejected under 35 U.S.C. 103 as being unpatentable over Rosenbluth (US 2015/0321000) in view of Vallejo et al (US 2016/0256689) hereinafter Vallejo.
Regarding claim 10, Rosenbluth discloses the system of claim 2 as discussed above, but fails to disclose wherein the device is further configured to deliver a priming electrical nerve stimulus prior to delivering the first electrical stimulus, wherein the priming electrical nerve stimulus is a non-theta burst stimulus. However, Vallejo discloses wherein the device is further configured to deliver a priming electrical nerve stimulus prior to delivering the first electrical stimulus ([0087] priming signal) , wherein the priming electrical nerve stimulus is a non-theta burst stimulus ([0087] The frequent pulsing of the priming signal also contributes to a lower threshold for depolarization of nerve fibers via membrane integration of the electrical stimulus). It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Rosenbluth with a priming electrical nerve stimulus prior to delivering the first electrical stimulus, wherein the priming electrical nerve stimulus is a non-theta burst stimulus. Such a modification would provide the predictable results of lowering the threshold for depolarization of nerve fibers (Vallejo, [0087]).
Claim(s) 11 is rejected under 35 U.S.C. 103 as being unpatentable over Rosenbluth (US 2015/0321000).
Regarding claim 11, Rosenbluth discloses wherein the first electrical stimulus has a frequency of between about 5 Hz and about 30 Hz ([0014] the first stimulus has a frequency from about 10 to 5000 Hz). It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the method as taught by Rosenbluth with a frequency of between about 5 Hz and about 30 Hz, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art [In re Aller, 105 USPQ 233] and/or since it has been held that a prima facie case of obviousness exists where the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have the same properties. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 227 USPQ (Please see MPEP 2144.05).
Claim(s) 14 is rejected under 35 U.S.C. 103 as being unpatentable over Rosenbluth (US 2015/0321000) in view of Amurthur et al (US 2008/0288016) hereinafter Amurthur.
Regarding claim 14, Rosenbluth discloses the system of claim 3 as discussed above, but fails to disclose wherein the feedback information comprises heart rate variability. However, Amurthur discloses wherein the feedback information comprises heart rate variability ([0035] sensor for monitoring heart rate variability (HRV)). It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Rosenbluth with the feedback information comprises heart rate variability as taught by Amurthur. Such a modification would provide the predictable results of cardiac improvement therapy by adjusting the neural stimulation in response to the sensed parameter (Amurthur, Abstract).
Claim(s) 18 and 20-21 are rejected under 35 U.S.C. 103 as being unpatentable over Moffitt (US 2016/0082253) in view of Rosenbluth (US 2015/0321000).
Regarding claim 18, Moffitt discloses wherein the first controller and the second controller ([0036] control modules 102a-b) each comprise a processor ([0066] control module (102 in FIG. 1) may include the same components shown in, and described with reference to, FIG. 5; [0067] processor 504) but fails to disclose wherein the first controller and the second controller each comprise a processor and a memory for receiving the feedback information from the input source that, when executed by the processor, cause the device to: adjust one or more parameters of the first electrical stimulus based at least in part on the feedback information; and adjust one or more parameters of the second electrical stimulus based at least in part on the feedback information independent from the first electrical stimulus; and wherein the first electrical stimulus and the second electrical stimulus both comprise burst stimulation.
However, Rosenbluth discloses a controller ([0130] Decision Unit 702) comprising a processor ([0127] processor 797) and a memory ([0127] memory 770) for receiving the feedback information from the input source ([0127] 780) that, when executed by the processor, cause the device to:
adjust one or more parameters of the first electrical stimulus based at least in part on the feedback information ([0212] processor 797 can also receive information from the sensors 780 and process that information on board and adjust the stimulation accordingly); and
adjust one or more parameters of the second electrical stimulus based at least in part on the feedback information independent from the first electrical stimulus ([0212] processor 797 can also receive information from the sensors 780 and process that information on board and adjust the stimulation accordingly); and
wherein the first electrical stimulus and the second electrical stimulus both comprise burst stimulation ([0147] As shown in FIG. 10B, bursts of high-frequency stimulation may be timed).
It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the first and second controllers as taught by Moffitt to each comprise a processor and a memory for receiving the feedback information from the input source that, when executed by the processor, cause the device to: adjust one or more parameters of the first electrical stimulus based at least in part on the feedback information; and adjust one or more parameters of the second electrical stimulus based at least in part on the feedback information independent from the first electrical stimulus; and wherein the first electrical stimulus and the second electrical stimulus both comprise burst stimulation as taught by Rosenbluth. Such a modification would provide the predictable results of delivering an adaptive closed-loop control of the stimulation.
Regarding claim 20, Moffitt discloses the system of claim 17 as discussed above, but fails to disclose wherein the feedback information comprises information relating to nocturia events of the patient. However, Rosenbluth discloses wherein the feedback information comprises information relating to nocturia events of the patient ([0132] sensor 780 could include motion sensors including accelerometers). It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Moffitt with the feedback information comprises information relating to nocturia events of the patient as taught by Rosenbluth. Such a modification would provide the predictable results of delivering an adaptive closed-loop control of the stimulation in order to improve the user’s sleep quality.
Regarding claim 21, Moffitt discloses the system of claim 17 as discussed above, but fails to disclose wherein the feedback information comprises information relating to patient sleep state. However, Rosenbluth discloses wherein the feedback information comprises information relating to patient sleep state ([0178] sensors may also be used to determine activities, such as to distinguish involuntary movements (e.g. tremor) from voluntary movements (e.g. drinking, writing) or the presence and absence of the tremor relative to the time of day or other detected activities such as sleep/wake cycles). It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Moffitt with the feedback information comprises information relating to patient sleep state as taught by Rosenbluth. Such a modification would provide the predictable results of delivering an adaptive closed-loop control of the stimulation in order to improve the user’s sleep quality.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WILLOW GRACE WELCH whose telephone number is (703)756-1596. The examiner can normally be reached Usually M-F 8:00am - 4:00pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Benjamin Klein can be reached at 571-270-5213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/WILLOW GRACE WELCH/Examiner, Art Unit 3792
/William J Levicky/Primary Examiner, Art Unit 3796
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