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 § 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.
Claim(s) 1-8, 11-15, and 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Perez(US 20180085580 A1) in view of Bengtsson(CN 101401314 A) (both cited previously), and further in view of Shepard(US 20200230400 A1).
Regarding claim 1, Perez discloses a system for wirelessly providing therapy to one or more anatomical elements comprising(The device is adapted to provide electrical stimulation as per stimulation protocols and to communicate wirelessly with a companion control device configured to monitor and record appetite patterns of the patient and deliver titrated therapy[abstract]): a first capsule configured to wirelessly transmit instructions to a second capsule; a second capsule configured to receive the wirelessly transmitted instructions; a processor; and a memory storing data for processing by the processor, the data, when processed, causes the processor to: receive an activation signal; apply a first current to a first anatomical element using the first capsule based on the activation signal; and wirelessly transmit a first set of instructions to the second capsule to cause the second capsule to apply a second current to a second anatomical element(an electrical dermal patch comprising: a housing; a controller positioned within the housing; at least one electrode in physical communication with the housing and adapted to be in electrical contact with the patient's skin; and, a pulse generator positioned within the housing and in electrical communication with the controller and said at least one electrode, wherein the pulse generator is configured to generate a plurality of stimulation sessions comprising a plurality of electrical pulses defined by stimulation parameters; a first plurality of programmatic instructions stored in a non-transient memory in a client device separate from the electrical dermal patch, wherein, when executed, said first plurality of programmatic instructions communicates with said electrical dermal patch and prompts the patient to input data indicative of the patient's degree of appetite via a microphone or display of said client device; and a second plurality of programmatic instructions stored in a non-transient memory in the client device or another device separate from the electrical dermal patch, wherein, when executed, the second plurality of programmatic instructions receives the data indicative of the patient's degree of appetite, processes the data indicative of the patient's degree of appetite to develop predictions of whether the patient's degree of appetite will be above or below a threshold value in a future time window[0142]). Perez fails to explicitly define a wherein each of the first capsule and the second capsule comprise an electrode, wherein the first capsule comprises a first body and the second capsule comprises a second body, each of the first body and the second body comprising a hinge to enable each of the first body and the second body to move between an open position that enables placement on the one or more anatomical elements and a closed position that encompasses the one or more anatomical elements after placement on the one or more anatomical elements, and wherein each of the first capsule and the second capsule further comprises a locking mechanism to lock the first body and the second body in the closed position and secure the first body and the second body to the one or more anatomical elements; and a first and second capsule to transmit and receive instruction signals.
However, Bengtsson teaches the controller unit comprises: a first controller unit transmitter adapted to transmit information to the transducer coil, adapted to transmit the second control information to the process unit receiver controller unit transmitter adapted to receive information from the controller unit of the processing unit transmitter to a receiver, and is connected with the first and the second controller unit transmitter and controller unit receiver-controller unit processor, wherein the first device of communication comprises the transducer coil and the first controller unit transmitter. and the second communication device comprises a processing unit transmitter, the process unit receiver, the second controller unit transmitter, and a controller unit receiver(see attached translation, page 4, paragraph 1).
It would be obvious to one of ordinary skill in the art before the effective date to configure the electrical stimulation system of Perez with the medical device communication system of Bengtsson. The controller functions similarly to the capsule in the application and the sequence of the system with one controller transmitting information and a second receiving controller defines a clear and effective communication pattern for devices.
However, Shepard teaches “The electrode mounting devices 110, 120, 130 each include a locking mechanism to secure the first and second wings 113, 114, and specifically their first and second cuff portions 115, 117, in the looped configuration. In this embodiment, the locking mechanism is provided in part by an opening 1131 of the first wing 113, the opening 1131 being located at a transition between the first cuff portion 115 and the first elongate extension portion 116. The second wing 114 is movable to extend at least partly through the opening 1131, the movement bringing the second ends 1152, 1172 of the first and second cuff portions 115, 117 into engagement to form the loop A as shown in FIG. 4b[0104]. The electrode mounting device may comprise a pivot such as a hinge or bearing, e.g. a flexible bearing, that connects the first ends of the cuff portions together[0033]. Each electrode mounting device may comprise a first wing and a second wing that are adapted to extend on opposite sides of the peripheral nerve and to be engageable with each other to form the loop[0027][Fig. 5a][Fig. 5b]”,
It would be obvious to one of ordinary skill in the art before the effective filing date to configure the electrical stimulation system of Perez with the hinge electrode mechanism of the nerve electrode array of Shepard. Doing so would specify multiple electrodes(capsules) to be configured with hinges to better attach to the anatomical elements of the patient for optical stimulation.
Regarding claim 2, Perez in view of Bengtsson and Shepard teaches the system of claim 1, wherein the first current comprises a low frequency stimulation, the first anatomical element comprises a celiac branch of a nerve, the second current comprises a high frequency blockade, and the second anatomical element comprises a hepatic branch of the nerve(Perez - In some embodiments, a stimulation protocol includes alternating stimulation sessions between a first session having a low pulse frequency, for example, less than 50 Hz, followed by a second session having a high pulse frequency, for example, greater than 50 Hz[1166]. Optionally, said electrical dermal patch is adapted to be adhered to the epidermis of the patient such that an electrical field, generated by said plurality of stimulation sessions, directly contacts at least one of the patient's C5, C6, C7, C8, T1, T2, T3, T4, T5, T6, T7, T8, T9, T10, T11, and T12 frontal and lateral dermatomes[0251]. Optionally, the second plurality of stimulation parameters are selected such that, after applying a stimulation session defined by the second plurality of stimulation parameters, a hepatic gluconeogenesis of said patient is lowered by at least 1% relative to the hepatic gluconeogenesis prior to applying the stimulation session[0183]).
Regarding claim 3, Perez in view of Bengtsson and Shepard teaches the system of claim 1, but Perez fails to disclose wherein the locking mechanism when unlocked, allows the first body and the second body to move to the open position.
However, Shepard teaches “FIGS. 5a to 5e show steps taken to move the electrode mounting device of FIGS. 4a and 4b from the open to the closed configuration relative to a peripheral nerve[0070]. electrodes 2, 12, and/or 112. One or more flaps 12 can be spring loaded to keep the flap closed when the device 16 is idle[0049]. The electrode mounting devices 110, 120, 130 each include a locking mechanism to secure the first and second wings 113, 114, and specifically their first and second cuff portions 115, 117, in the looped configuration. In this embodiment, the locking mechanism is provided in part by an opening 1131 of the first wing 113, the opening 1131 being located at a transition between the first cuff portion 115 and the first elongate extension portion 116[0103]”.
It would be obvious to one of ordinary skill in the art before the effective filing date to configure the electrical stimulation system of Perez with the hinge electrode mechanism of the nerve electrode array of Shepard. Doing so would specify multiple electrodes(capsules) to be configured with hinges to better attach to the anatomical elements of the patient for optical stimulation.
Regarding claim 4, Perez in view of Bengtsson and Shepard teaches the system of claim 3, wherein each of the first body and the second body comprises a first bore and a second bore, respectively, wherein at least one first electrode is positioned in the first bore and at least one second electrode is positioned in the second bore(Perez - discrete components of the controller assembly 431 are either surface mounted or “thru hole” mounted comparable to the process used in the manufacture of rigid printed circuit boards[0810]. Perforation holes 542 along the anchor 540 perimeter length are included so that the material of the overmold portions 505, 510 can seep therein and attach thereto to fully envelope the electrode contacts 535 as well as the hydrogel pads 520[0825]).
Regarding claim 5, Perez in view of Bengtsson and Shepard teaches the system of claim 1, wherein each of the first capsule and the second capsule comprises a first interface and a second interface, respectively, each of the first interface and the second interface configured to utilize a communication channel between each of the first capsule and the second capsule, respectively, and a third device, and wherein each of the first capsule and the second capsule is configured to wirelessly transmit data to the third device via the communication channel(Perez - In embodiments, the electrical dermal patch, using the plurality of programmatic instructions configured to execute on the device external to the electrical dermal patch, interfaces with a second device (third party device) to automatically receive at least one of the data[0953] a housing comprising a controller in electrical communication with a pulse generator; and at least two electrodes adapted to be adhered to the patient's skin and in electrical communication with the pulse generator, wherein the controller comprises programmatic instructions that, when executed and transmitted to the pulse generator, cause the pulse generator to generate and transmit to the at least two electrodes a first electrical stimulation pulse and a second electrical stimulation pulse[0095]).
Regarding claim 6, Perez in view of Bengtsson and Shepard teaches the system of claim 5, wherein the third device is a user device(Perez - wherein, when executed, said second plurality of programmatic instructions determines an appetite pattern of the patient based upon said inputted data; and a third plurality of programmatic instructions stored in a non-transient memory in the client device or another device separate from the electrical dermal patch, wherein, when executed, said third plurality of programmatic instructions determines an intervention and generates said intervention based on the appetite pattern[0127]).
Regarding claim 7, Perez in view of Bengtsson and Shepard teaches the system of claim 1, wherein each of the first capsule and the second capsule are configured to record data resulting from the applied first current and the applied second current, respectively(Perez - Inputs from the electrical neuro-stimulation device and from other sources of information, for example, a device, with physiological sensors, configured to be worn on the human body, such as around the wrist, in order to monitor, acquire, record, and/or transmit the physiological data would be stored[0053]).
Regarding claim 8, Perez in view of Bengtsson and Shepard teaches the system of claim 1, wherein the memory stores further data for processing by the processor that, when processed, causes the processor to: wirelessly transmit a second set of instructions to the second capsule to cause the second capsule to deactivate(Perez - associating or linking the TPM and the user enables a plurality of functions such as, but not limited to, allowing the TPM to regularly receive and access, in real time or near real time, the user's health related information and progress reports related to various therapeutic objectives, to accordingly modulate or titrate stimulation protocols and parameters when needed; and enabling the TPM to deactivate and reactivate the EDP device remotely, when needed[1309]).
Regarding claim 11, Perez in view of Bengtsson and Shepard teaches the system of claim 1, wherein the second capsule is configured to only receive instructions and execute the instructions from the first capsule(Perez - a first plurality of programmatic instructions stored in a non-transient memory in a client device separate from the electrical dermal patch, wherein, when executed, said first plurality of programmatic instructions communicates with said electrical dermal patch and prompts the patient to input data indicative of the patient's degree of appetite via a microphone or display of said client device; and a second plurality of programmatic instructions stored in a non-transient memory in the client device or another device separate from the electrical dermal patch, wherein, when executed, the second plurality of programmatic instructions receives the data indicative of the patient's degree of appetite[0142]).
Regarding claim 13, Perez discloses a system for wirelessly providing therapy to one or more anatomical elements(The device is adapted to provide electrical stimulation as per stimulation protocols and to communicate wirelessly with a companion control device configured to monitor and record appetite patterns of the patient and deliver titrated therapy[abstract]) comprising: a first capsule configured to wirelessly transmit instructions to a second capsule; a processor; and a memory storing data for processing by the processor, the data, when processed, causes the processor to: apply a first current to the first anatomical element using the first capsule; wirelessly transmit a first set of instructions to the second capsule to cause the second capsule to apply a second current to a second anatomical element; and wirelessly transmit a second set of instructions to the second capsule to cause the second capsule to deactivate(an electrical dermal patch comprising: a housing; a controller positioned within the housing; at least one electrode in physical communication with the housing and adapted to be in electrical contact with the patient's skin; and, a pulse generator positioned within the housing and in electrical communication with the controller and said at least one electrode, wherein the pulse generator is configured to generate a plurality of stimulation sessions comprising a plurality of electrical pulses defined by stimulation parameters; a first plurality of programmatic instructions stored in a non-transient memory in a client device separate from the electrical dermal patch, wherein, when executed, said first plurality of programmatic instructions communicates with said electrical dermal patch and prompts the patient to input data indicative of the patient's degree of appetite via a microphone or display of said client device; and a second plurality of programmatic instructions stored in a non-transient memory in the client device or another device separate from the electrical dermal patch, wherein, when executed, the second plurality of programmatic instructions receives the data indicative of the patient's degree of appetite, processes the data indicative of the patient's degree of appetite to develop predictions of whether the patient's degree of appetite will be above or below a threshold value in a future time window[0142]. Associating or linking the TPM and the user enables a plurality of functions such as, but not limited to, allowing the TPM to regularly receive and access, in real time or near real time, the user's health related information and progress reports related to various therapeutic objectives, to accordingly modulate or titrate stimulation protocols and parameters when needed; and enabling the TPM to deactivate and reactivate the EDP device remotely, when needed.[1309]). Perez fails to explicitly define a first and second capsule to transmit and receive instruction signals, and wherein the first capsule and the second capsule comprise an electrode, wherein the first capsule comprises a first body and the second capsule comprises a second body, each of the first body and the second body comprising a hinge to enable each of the first body and the second body to move between an open position that enables placement on the one or more anatomical elements and a closed position, and wherein, in the closed position, the first body and the second body are configured to wrap around a first anatomical element and a second anatomical element after placement on the first anatomical element and a second anatomical element; and wherein each of the first capsule and the second capsule further comprises a locking mechanism to lock the first body and the second body in the closed position and secure the first body and the second body to the first anatomical element and the second anatomical element.
However, Bengtsson teaches the controller unit comprises: a first controller unit transmitter adapted to transmit information to the transducer coil, adapted to transmit the second control information to the process unit receiver controller unit transmitter adapted to receive information from the controller unit of the processing unit transmitter to a receiver, and is connected with the first and the second controller unit transmitter and controller unit receiver-controller unit processor, wherein the first device of communication comprises the transducer coil and the first controller unit transmitter. and the second communication device comprises a processing unit transmitter, the process unit receiver, the second controller unit transmitter, and a controller unit receiver(see attached translation, page 4, paragraph 1).
It would be obvious to one of ordinary skill in the art before the effective date to configure the electrical stimulation system of Perez with the medical device communication system of Bengtsson. The controller functions similarly to the capsule in the application and the sequence of the system with one controller transmitting information and a second receiving controller defines a clear and effective communication pattern for devices.
However, Shepard teaches “The electrode mounting devices 110, 120, 130 each include a locking mechanism to secure the first and second wings 113, 114, and specifically their first and second cuff portions 115, 117, in the looped configuration. In this embodiment, the locking mechanism is provided in part by an opening 1131 of the first wing 113, the opening 1131 being located at a transition between the first cuff portion 115 and the first elongate extension portion 116. The second wing 114 is movable to extend at least partly through the opening 1131, the movement bringing the second ends 1152, 1172 of the first and second cuff portions 115, 117 into engagement to form the loop A as shown in FIG. 4b[0104]. The electrode mounting device may comprise a pivot such as a hinge or bearing, e.g. a flexible bearing, that connects the first ends of the cuff portions together[0033]. Each electrode mounting device may comprise a first wing and a second wing that are adapted to extend on opposite sides of the peripheral nerve and to be engageable with each other to form the loop[0027][Fig. 5a][Fig. 5b]. Each electrode mounting device may be adapted to clamp to the peripheral nerve. Each electrode mounting device may be adapted to form a loop around the peripheral nerve[0026]”.
It would be obvious to one of ordinary skill in the art before the effective filing date to configure the electrical stimulation system of Perez with the hinge electrode mechanism of the nerve electrode array of Shepard. Doing so would specify multiple electrodes(capsules) to be configured with hinges to better attach to the anatomical elements of the patient for optical stimulation.
Regarding claim 14, Perez in view of Bengtsson and Shepard teaches the system of claim 13, wherein the second set of instructions is sent based on user input received by the first capsule(Perez- a first plurality of programmatic instructions stored in a non-transient memory in a client device separate from the electrical dermal patch, wherein, when executed, said first plurality of programmatic instructions communicates with said electrical dermal patch and prompts the patient to input data indicative of the patient's degree of appetite via a microphone or display of said client device; and a second plurality of programmatic instructions stored in a non-transient memory in the client device or another device separate from the electrical dermal patch, wherein, when executed, the second plurality of programmatic instructions receives the data indicative of the patient's degree of appetite[0142]).
Regarding claim 15, Perez in view of Bengtsson and Shepard teaches the system of claim 13, wherein the memory stores further data for processing by the processor that, when processed, causes the processor to :receive an activation signal(Perez - the trigger is a signal from a health care provider and received by the plurality of programmatic instructions and said signal causes the plurality of programmatic instructions to modify the plurality of stimulation sessions by reducing at least one of a number, an amplitude, a frequency or a pulse width of the electrical pulses of the plurality of stimulation sessions[0079]. programmatic instructions stored in a non-transient memory in said at least one server, wherein, when executed, said second plurality of programmatic instructions receives the data indicative of the patient's degree of appetite, processes the data indicative of the patient's degree of appetite to determine if the patient's degree of appetite is above or below a threshold value[0202]).
Regarding claim 18, Perez in view of Bengtsson and Shepard teaches the system of claim 13, wherein each of the first capsule and the second capsule are configured to record data.(Perez - Inputs from the electrical neuro-stimulation device and from other sources of information, for example, a device, with physiological sensors, configured to be worn on the human body, such as around the wrist, in order to monitor, acquire, record, and/or transmit the physiological data would be stored[0053]).
Regarding claim 19, Perez in view of Bengtsson and Shepard teaches the system of claim 13, wherein each of the first capsule and the second capsule comprises a first interface and a second interface, respectively, each of the first interface and the second interface configured to utilize a communication channel between each of the first capsule and the second capsule, respectively, and a third device, and wherein each of the first capsule and the second capsule is configured to wirelessly transmit data to the third device via the communication channel(Perez - In embodiments, the electrical dermal patch, using the plurality of programmatic instructions configured to execute on the device external to the electrical dermal patch, interfaces with a second device (third party device) to automatically receive at least one of the data[0953] a housing comprising a controller in electrical communication with a pulse generator; and at least two electrodes adapted to be adhered to the patient's skin and in electrical communication with the pulse generator, wherein the controller comprises programmatic instructions that, when executed and transmitted to the pulse generator, cause the pulse generator to generate and transmit to the at least two electrodes a first electrical stimulation pulse and a second electrical stimulation pulse[0095]). Perez fails to explicitly disclose both “capsules” having an interface.
However, Bengtsson teaches “Advantageously also, the processor device is adapted to receive flow instruction from the control unit, the control unit comprises a user interface, said user interface allows user input stream instructions for subsequent transmission to the processing unit, for example, programming the basic infusion rate profile or a bolus. the processing unit can be adapted to be implanted or outlet[zzzz]”.
It would be obvious to one of ordinary skill in the art before the effective date to configure the electrical stimulation system of Perez with the medical device communication system of Bengtsson. The controller functions similarly to the capsule in the application and the sequence of the system with one controller transmitting information and a second receiving controller defines a clear and effective communication pattern for devices.
Regarding claim 20, Perez discloses a system for wirelessly providing therapy to one or more anatomical elements(The device is adapted to provide electrical stimulation as per stimulation protocols and to communicate wirelessly with a companion control device configured to monitor and record appetite patterns of the patient and deliver titrated therapy[abstract]) comprising: a first capsule configured to wirelessly transmit instructions to a second capsule, the first capsule comprising a first body and one or more first electrodes configured to apply a current to an anatomical element; a second capsule configured to receive the wirelessly transmitted instructions, the second capsule comprising a second body and one or more second electrodes configured to apply a current to the anatomical element; a processor; and a memory storing data for processing by the processor, the data, when processed, causes the processor to: receive an activation signal; apply a first current to a first anatomical element using the first capsule based on the activation signal, the first current applied using the one or more first electrodes; wirelessly transmit a first set of instructions to the second capsule to cause the second capsule to apply a second current to a second anatomical element using the one or more second electrodes; and wirelessly transmit a second set of instructions to the second capsule to cause the second capsule to deactivate(an electrical dermal patch comprising: a housing; a controller positioned within the housing; at least one electrode in physical communication with the housing and adapted to be in electrical contact with the patient's skin; and, a pulse generator positioned within the housing and in electrical communication with the controller and said at least one electrode, wherein the pulse generator is configured to generate a plurality of stimulation sessions comprising a plurality of electrical pulses defined by stimulation parameters; a first plurality of programmatic instructions stored in a non-transient memory in a client device separate from the electrical dermal patch, wherein, when executed, said first plurality of programmatic instructions communicates with said electrical dermal patch and prompts the patient to input data indicative of the patient's degree of appetite via a microphone or display of said client device; and a second plurality of programmatic instructions stored in a non-transient memory in the client device or another device separate from the electrical dermal patch, wherein, when executed, the second plurality of programmatic instructions receives the data indicative of the patient's degree of appetite, processes the data indicative of the patient's degree of appetite to develop predictions of whether the patient's degree of appetite will be above or below a threshold value in a future time window[0142]. Associating or linking the TPM and the user enables a plurality of functions such as, but not limited to, allowing the TPM to regularly receive and access, in real time or near real time, the user's health related information and progress reports related to various therapeutic objectives, to accordingly modulate or titrate stimulation protocols and parameters when needed; and enabling the TPM to deactivate and reactivate the EDP device remotely, when needed.[1309]). Perez fails to explicitly define a first and second capsule to transmit and receive instruction signals, and wherein each of the first body and the second body comprise a hinge to enable each of the first body and the second body to move between an open position that enables placement on the anatomical element and a closed position that encompasses the anatomical element after placement on the anatomical element, and wherein each of the first capsule and the second capsule further comprises a locking mechanism to lock the first body and the second body in the closed position and secure the first body and the second body to the anatomical element.
However, Bengtsson teaches the controller unit comprises: a first controller unit transmitter adapted to transmit information to the transducer coil, adapted to transmit the second control information to the process unit receiver controller unit transmitter adapted to receive information from the controller unit of the processing unit transmitter to a receiver, and is connected with the first and the second controller unit transmitter and controller unit receiver-controller unit processor, wherein the first device of communication comprises the transducer coil and the first controller unit transmitter. and the second communication device comprises a processing unit transmitter, the process unit receiver, the second controller unit transmitter, and a controller unit receiver(see attached translation, page 4, paragraph 1).
It would be obvious to one of ordinary skill in the art before the effective date to configure the electrical stimulation system of Perez with the medical device communication system of Bengtsson. The controller functions similarly to the capsule in the application and the sequence of the system with one controller transmitting information and a second receiving controller defines a clear and effective communication pattern for devices.
However, Shepard teaches “The electrode mounting devices 110, 120, 130 each include a locking mechanism to secure the first and second wings 113, 114, and specifically their first and second cuff portions 115, 117, in the looped configuration. In this embodiment, the locking mechanism is provided in part by an opening 1131 of the first wing 113, the opening 1131 being located at a transition between the first cuff portion 115 and the first elongate extension portion 116. The second wing 114 is movable to extend at least partly through the opening 1131, the movement bringing the second ends 1152, 1172 of the first and second cuff portions 115, 117 into engagement to form the loop A as shown in FIG. 4b[0104]. The electrode mounting device may comprise a pivot such as a hinge or bearing, e.g. a flexible bearing, that connects the first ends of the cuff portions together[0033]. Each electrode mounting device may comprise a first wing and a second wing that are adapted to extend on opposite sides of the peripheral nerve and to be engageable with each other to form the loop[0027][Fig. 5a][Fig. 5b]. Each electrode mounting device may be adapted to clamp to the peripheral nerve. Each electrode mounting device may be adapted to form a loop around the peripheral nerve[0026]”.
It would be obvious to one of ordinary skill in the art before the effective filing date to configure the electrical stimulation system of Perez with the hinge electrode mechanism of the nerve electrode array of Shepard. Doing so would specify multiple electrodes(capsules) to be configured with hinges to better attach to the anatomical elements of the patient for optical stimulation.
Regarding claim 21, Perez in view of Bengtsson and Shepard teaches the system of claim 13, wherein the second set of instructions is sent at an end of the period of time(Perez - Optionally, the method further comprises, using a second plurality of programmatic instructions configured to execute on a second device external to the electrical dermal patch and in data communication with the plurality of programmatic instructions configured to execute on the device external to the electrical dermal patch, prompting a health care provider to input the data indicative of the weight loss goal. The method may further comprises, after the predefined period of time, using the plurality of programmatic instructions configured to execute on the device external to the electrical dermal patch[0067]).
Claim(s) 9-10, and 16-17 are rejected under 35 U.S.C. 103 as being unpatentable over Perez in view of Bengtssom and Shepard as applied to claims 1 and 13 above, and further in view of Tamir(WO 2017115368 A1) (cited previously).
Regarding claim 9, Perez in view of Bengtsson and Shepard teaches the system of claim 1, but fails to disclose wherein the activation signal is triggered when a predetermined parameter is met. However, Tamir teaches “The method includes the steps of detecting a predetermined physiological state and applying stimulation to one of the cranial nerves during the predetermined physiological state by one or more stimulators of a neuromodulation system[abstract]” .
It would be obvious to one of ordinary skill in the art before the effective date to configure the electrical stimulation system of Perez with the neuromodulation system of Tamir. Clarifying that the predetermined state must be met before stimulation begins helps define the timing and efficiency of the stimulation system.
Regarding claim 10, Perez in view of Bengtsson, Shepard, and further in view of Tamir teaches the system of claim 9, wherein the predetermined parameter comprises at least one of a high glycemic value, a post prandial response, or a patient activation(Perez - Optionally, the second plurality of stimulation parameters are selected such that, after applying a stimulation session defined by the second plurality of stimulation parameters, a glycemic indicator of the patient improves relative to the patient's said glycemic indicator prior to applying the stimulation session[0163]).
Regarding claim 16, Perez in view of Bengtsson and Shepard teaches the system of claim 15, but fails to disclose wherein the activation signal is triggered when a predetermined parameter is met. However, Tamir teaches “The method includes the steps of detecting a predetermined physiological state and applying stimulation to one of the cranial nerves during the predetermined physiological state by one or more stimulators of a neuromodulation system[abstract]” .
It would be obvious to one of ordinary skill in the art before the effective date to configure the electrical stimulation system of Perez with the neuromodulation system of Tamir. Clarifying that the predetermined state must be met before stimulation begins helps define the timing and efficiency of the stimulation system.
Regarding claim 17, Perez in view of Bengtsson, Shepard and further in view of Tamir teaches the system of claim 16, wherein the predetermined parameter comprises at least one of a high glycemic value, a post prandial response, or a patient activation(Perez - Optionally, the second plurality of stimulation parameters are selected such that, after applying a stimulation session defined by the second plurality of stimulation parameters, a glycemic indicator of the patient improves relative to the patient's said glycemic indicator prior to applying the stimulation session[0163]).
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-11, and 13-21 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Applicant argues that Perez fails to disclose a first and second electrode capsule with a hinge for attachment to an anatomical element and a locking transition to an open and closed position. However, new art Shepard teaches an nerve electrode nerve stimulator with electrodes that wrap around nerves of the patient and contain locking mechanisms that transition between an open and closed state[Figs. 3-6b], “The first elongate extension portion 118 is then pulled through the opening 1131 (FIG. 5d) to a point where the second ends 1152, 1172 of the first and second cuff portions 115, 117 engage each other to form the loop A about the peripheral nerve 200 (FIGS. 5e and 6b). At this point, the first and second wings 113, 114 lock to each other by virtue of the shoulder 1141 of the second wing 114 squeezing through the opening 1131 and subsequently expanding, preventing retraction of the second elongate extension portion 118 back through the opening 1131[0107]”. The natural combination of Perez with Bengtsson and Shepard as wireless electrical stimulation devices to disclose all the claimed material. Therefore the 103 rejections for all claims stands.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARIA CATHERINE ANTHONY whose telephone number is (703)756-4514. The examiner can normally be reached 7:30 am - 4:30 pm, EST, M-F.
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/MARIA CATHERINE ANTHONY/Examiner, Art Unit 3796
/CARL H LAYNO/Supervisory Patent Examiner, Art Unit 3796