DETAILED ACTION
Response to Amendment
This action is in response to the amendment after non-final filed 11 December 2025. Claims 32-34, 37, 39, 42, 46-51, 53-58, and 62 are pending.
Response to Arguments
Applicant’s arguments filed with respect to the rejection(s) of claim(s) 32 under Gesotti (US Publication no. 2004/0088025) in view of Chahine et al. (US Publication no. 2017/0056644), further in view of Okimoto (WO 2019/093069 – relying on English Machine translation provided by WIPO of PCT/JP2018/038090). have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Harry et al. (US Publication no. 2008/0077192) in view of Maghribi et al. (US Publication no. 2004/0243204).
Rejections previously made under 35 USC 112 and claim objection raised have been overcome by Applicant’s amendment and are thereby withdrawn.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claim 62 is rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) does/do not fall within at least one of the four categories of patent eligible subject matter. Claim 62 appears to recite a joint or part of the body as required structure of the embodiment claimed therein. Body parts may not be claimed as structure in an invention. Instead, the language should be amended in a manner that recites the stimulation devices are “configured to” or “adapted to” be attached near the desired body part.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 39 recites the limitation "the stretchable electrical conductions" in lines 1-2. There is insufficient antecedent basis for this limitation in the base claim.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 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) 32-34, 39, and 42 is/are rejected under 35 U.S.C. 103 as being unpatentable over Harry et al. (US Publication no. 2008/0077192) in view of Maghribi et al. (US Publication no. 2004/0243204).
In regard to claim 32, Harry et al. disclose a neuro-stimulation system for guiding movement of one or more parts of a body of a subject (para 15), the stimulation system comprising (refer to figures 10A and 14A, and in subsequent figures 13A,B, and 14A,B):
at least two stimulation devices 2110 and 2120, each stimulation device positioned, in use, adjacent the one or more parts of a body, (para 97 and 98, stimulation system 200 includes delivery of electrical stimulation and mechanical vibration stimulation, the two stimulation devices comprises by electrode 2110 and vibration element 2120 co-located on pads 2102A and 2102B; also see figures 13A,B with para 103depicting the device secured to an appendage of a user) each stimulation device comprising:
a stretchable stimulator circuit 2130 comprising at least one stimulator configured 2100, in use, to provide a mechanical vibration stimulus to the one or more parts of a body to guide movement of the one or more parts of the body (para 110, flex circuit 2130 includes stimulator 2100 comprising electrical stimulation electrode 2110 and vibration element 2120, vibration element 2120 provides a mechanical stimulus to a body part, para 98, 106);
a flexible material substrate 2130 (depicted in figure 10a, comprising arms 2104 a and 2104 B) adapted to be worn by the subject and to conform to an outer surface of the one or more parts of the body (para 103, figures 13A,B the neuro-stimulation system is depicted conforming to a user’s appendage); wherein the stretchable stimulator circuit 2130 is supported by the flexible material substrate so the at least one stimulator is secured to the one or more body parts of the body by the flexible material substrate (para 103 and 104, contact areas 2102A and 2102B are placed onto a user’s skin to deliver the electrical and mechanical stimuli, figures 13A,B show that the contact areas 2102A,B may be flexibly conformed via 2130 to the various parts of the user’s body); and
at least one controller 2200 operably connected, in use, to the stretchable stimulator circuits 2130 of the at least two stimulation devices 2110/2120 device to control the at least one stimulator in the at least two stimulator devices (para 97),
wherein a control signal sequence in communication with the at least two stimulation devices deliver the mechanical vibration stimulus at multiple points (via electrode 2110 and vibrator 2120 of two contact pads 2101A and 2102B which provide multiple stimulation points) on to the one or more parts of the body to cause synchronized stimulation of the body (para 97, stimulator 2100 is placed into contact with a body part of a subject, or patient, to deliver electrical current and/or mechanical vibration. The controller 2200 is operated to control the delivery of the electrical current and/or mechanical vibration through the stimulator 2100 according to the neuro-stimulation therapies, the therapies may be delivered simultaneously (para 98, and see the embodiment of para 88 which is considered to pertain to the embodiment of figures 10 A,B), the simultaneous delivery of therapy considered to comprise synchronized delivery of electrical and mechanical therapy), and
wherein the stretchable stimulator circuit 2130 of the at least two stimulation devices 2110/2120 allow components of the stimulation devices to move closer together and apart from each other in one or more directions relative to the at least one stimulator, enabling the stimulation devices to adapt to changing shape and movement of the part of the body to maintain effective contact between the at least one simulator and the part of the body to effectively provide stimulation to the part of the body to effect the guiding movement (this feature is considered to be demonstrated by figures 13A,B that enables contacts 2012A and 2102B to be bent to conform to the shape or orientation of a user’s appendage thus permitting movement as claimed).
Harry et al. is considered to substantially describe each and every limitation of the invention as claimed such that Harry et al. anticipates the present invention. However, in as much as flexible circuit 2130 permits movement in the desired manner and for allowing conformance to body structures, it is unclear that the flexible circuit 2130 has stretchable properties. Harry et al. provides suggestion for modifying the neuro-stimulation system, such as the one relied on in figures 10A,B into a garment composed of stretchable material in order to improve an operator's ability to use the device or to enhance the effectiveness of the device (para 16), wherein a stretchable garment provides the advantage of allowing the neuro-stimulation system to closely conform to the subject and securely hold the stimulation devices securely against the subject's skin to prevent displacement of the stimulation devices during the prolonged motion involved in an exercise regimen (para 84). As Harry et al. explicitly teach and suggest the modification of the neuro-stimulation system into a wearable garment, one of ordinary skill in the art would therefore find it is obvious to implement the stimulators into a stretchable configuration to enhance the user’s comfort when worn.
Maghribi et al. discloses a stretchable polymer-based electronic circuit. The device 500 depicted in figure 5 includes stretchable conductive circuit 503 and 504 and electronic component 502 embedded in a stretchable polymer substrate (para 9, 84 and 86). The apparatus 500 is configured to stretch in the longitudinal direction while maintaining the integrity of the circuit lines 503 and 504 and the electronic component 502. The stretchable electronic circuit 500 of Maghribi et al. is considered to useful in the configuration of arms 2104A,B and flexible circuit 2130 of Harry et al. to provide stress release and increased stretchability of arms to enhance conformance and fit of the device to a user’s body. Modification of flexible circuit 2130 and arms 2104A,B in Harry et al. to be a stretchable circuit is considered to have been obvious to one of ordinary skill in the art in order to allow stretchability in a longitudinal direction to enhance conformance and to provide stress relief to the conductors of circuit 2130 of arms 2104A,B when bent or flexed.
In regard to claim 33, Harry et al. further teach that the at least one other stimulation device is configured to provide an electrical vibration stimulus to the one or more parts of the body to guide movement of the one or more parts of the body (para 98 and 106).
In regard to claim 34, Harry et al. further teach that the one or more parts of the body is selected from the group consisting of a Golgi tendon organ, a muscle, a nerve, and a tendon (para 88, neuro-stimulation system may be a muscle stimulator, tendon stimulator, etc; also implied by the background teachings of para 5-9).
In regard to claim 39, Harry et al. in view of Maghribi et al. suggest the invention as claimed. Maghribi et al. teach that the stretchable electrical conductors 503/504 are comprised of conductive wires in a reduced or non-linear arrangement so as, in use, to extend in a direction in which the flexible substrate is stretched (figures 2 and 3, para 46, the conductive wires are in a zig-zag configuration to permit stretching along axis 205). Modification of a wearable garment embodiment of Harry et al. to include stretchable electrical conductors as claimed is considered to have been obvious to one of ordinary skill in the art in view of the teachings of Maghribi et al. which teaches that electrical conductors arranged in this manner to avoid damaging the conductors when the wearable garment is under tension when being worn.
In regard to claim 42, Harry et al. suggest modification into a garment (para 16 and 84). The garments facilitates contact between the stimulation device and intended body target (para 84).
In regard to claim 48, Harry et al. teach that the controller 2200 as used in the embodiment of figures 10A,B includes a rechargeable power supply that includes a rechargeable battery (para 123, 171, 172).
Claim(s) 37 and 47 is/are rejected under 35 U.S.C. 103 as being unpatentable over Harry et al. (US Publication no. 2008/0077192) and Maghribi et al. (US Publication no. 2004/0243204) in view of Kaib et al. (WO 2011/146448).
In regard to claim 37, Harry et al. in view of Maghribi et al., suggest the invention as claimed, however do not teach or suggest within the wearable garment embodiment includes the stretchable stimulator circuit comprises: stretchable electrical conductors extending longitudinally of the flexible substrate in a sinusoidal configuration; and short conductive wires interconnecting the stretchable electrical conductors and rigid stimulator components, and wherein the stretchable stimulator circuit is adapted to stretch longitudinally and/or laterally relative to the stimulator components to retain the stimulator components in contact with the wearer's skin and provide consistent mechanical stimulus during movement. Kaib et al. describe a wearable therapeutic device that includes a garment to provide electrical stimulation to the wearer. Figure 5 of Kaib et al. depicts a flexible, stretchable substrate 110 comprising a conductive wire/thread 505 sewn in a zigzag pattern and extending longitudinally through substrate 110. The zigzag pattern of the conductive thread 505 that can stretch as the garment is worn. Not numbered, but figure 5 is considered to depict short conductive wires that connect conductive wires 505 to electrodes 140 (e.g., the rigid components of the stimulator). Additionally, within the substrate 110, a control unit 130 is located therein as part of element 135 (see pages 23-24).
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Modification of the conductive wires in Harry et al. to include stretchable conductive wires and short conductive wires that connect between the stretchable wires and rigid electrodes is considered to have been obvious to one of ordinary skill in the art in order to avoid damaging the conductors when the wearable garment is under tension when being worn.
In regard to claim 47, Harry et al. in view of Maghribi et al. suggest the invention as claimed, however do not teach or suggest within the wearable garment embodiment includes controller as part of the stretchable stimulator circuit. Maghribi et al. teach that the stretchable circuit 500 includes an electronic component 502. However, it is not clear if the electronic component comprises a controller. Kaib et al. describe a wearable therapeutic device that includes a garment to provide electrical stimulation to the wearer. Figure 5 of Kaib et al. depicts a flexible, stretchable substrate 110 comprising a conductive wire/thread 505 sewn in a zigzag pattern and extending longitudinally through substrate 110. Additionally, within the substrate 110, a control unit 130 is located therein as part of element 135 (see pages 23-24). In this manner, it is considered that Kaib et al. demonstrates that a control unit 130may be part of a stretchable circuit. Modification of the invention described by Harry et al. and Maghribi et al. to provide the controller as part of the stretchable stimulator circuit is considered to have been obvious to one of ordinary skill in the art since it is explicitly demonstrated by Kaib et al. and would provide the advantage of reducing the bulk worn by the patient during use.
Claim(s) 46 and 49 is/are rejected under 35 U.S.C. 103 as being unpatentable over Harry et al. (US Publication no. 2008/0077192) and Maghribi et al. (US Publication no. 2004/0243204), in view of Peiffer et al. (US Publication no. 2020/0222686 – previously cited).
In regard to claim 46, Harry et al. in view of Maghribi et al. is considered to substantially suggest the invention as claimed, however does not teach further comprising padding to cushion the one or more parts of the body. Pieffer et al. describes a wearable system similar to the above documents, wherein Pieffer et al. includes cushioning material (para 390). Modification of the cited prior art to include cushioning material in the wearable garment embodiment of Harry et al. is considered to have been obvious to one of ordinary skill in the art to enhance user comfort.
In regard to claim 49, Harry et al. in view of Maghribi et al., is considered to substantially suggest the invention as claimed, however does not teach that the rechargeable power supply is configured for wireless charging. Pieffer et al. describes a wearable system similar to the above documents, wherein Pieffer et al. includes a power source wherein the power source can be charged wirelessly (para 473). Modification of the rechargeable battery of Harry et al. to be wirelessly recharged since Pieffer et al. explicitly demonstrates this feature for providing power to a wearable garment, the wireless recharging ability providing the benefit of allowing recharge without having to physically connect the device to a charging cord.
Claim(s) 50, 57, 58, and 62 is/are rejected under 35 U.S.C. 103 as being unpatentable over Harry et al. (US Publication no. 2008/0077192) and Maghribi et al. (US Publication no. 2004/0243204), in view of Gesotti (US Publication no. 2004/0088025 – previously cited).
In regard to claim 50, Harry et al. in view of Maghribi et al. is considered to substantially suggest the invention as claimed, however does not teach comprising at least one sensor operably connected with the controller, the at least one sensor configured to receive monitoring data to track movement of the subject. Gesotti discloses a stimulation system device for guiding movement of one or more parts of a body of a subject (para 17-21, Gesotti is directed to a system for treating symptoms of neurological movement disorders using a plurality of stimulation points). Gesotti includes at least one sensor operably connected with the controller, the at least one sensor configured to receive monitoring data (para 34-35, controller 108 is connected to one or more motion sensors 107). The sensor is a motion sensor that detects one or more movement parameters of a patient including lack of movement, acceleration, deceleration, etc (para 34). Modification of the stimulation system of Harry et al. to include a motion sensor is considered to have been obvious to one of ordinary skill in the art at the time of the invention since Gesotti teaches that the motion sensor provides information to the controller to control stimulation parameters provided to the stimulation electrodes and/or stimulators (para 35).
In regard to claim 57, Harry et al. in view of Maghribi et al. is considered to substantially suggest the invention as claimed, however does not teach that the controller 2200 comprises a user device wirelessly connected to the at least two stimulation devices, configured to display monitoring data and/or to transmit instructions to the controller to generate a control signal.
Gesotti teaches that the system comprises a user device wirelessly connected to the stimulation devices and configured to display monitoring data and/or to transmit instructions to the controller to generate a control signal (para 37, display and control panel 116 which may be wirelessly controlled via control interface 106; para 90, in one embodiment, the stimulators are controlled by a wireless link adjusting parameters and synchronizing stimulation). Modification of controller in Harry et al. to comprise a wirelessly connected device to the stimulators would provide the advantage of reducing bulk worn by the patient when using the device and since Gesotti explicitly show that the stimulation parameters may be adjusted and synchronized using a wireless control device.
In regard to claim 58, Harry et al. in view of Maghribi et al. is considered to substantially suggest the invention as claimed, however does not teach the at least two stimulation devices are adapted to deliver stimuli in a synchronized manner to the one or more parts of the body to guide movement of the one or more parts of the body, and wherein, in use, each of the at least two stimulations devices is configured to wireless communicate with the other(s) of the at least two stimulation devices. Harry et al. does teach that the stimulation provided by stimulators 2110 and 2120 may be provided simultaneously, which is considered to comprise a synchronized manner (para 76, 88, 96, and 98).
Gesotti teaches that the system comprises a user device wirelessly connected to the stimulation devices and configured to display monitoring data and/or to transmit instructions to the controller to generate a control signal (para 37, display and control panel 116 which may be wirelessly controlled via control interface 106; para 90, in one embodiment, the stimulators are controlled by a wireless link adjusting parameters and synchronizing stimulation). Modification of controller in Harry et al. to comprise a wirelessly connected device to the stimulators would provide the advantage of reducing bulk worn by the patient when using the device and since Gesotti explicitly show that the stimulation parameters may be adjusted and synchronized using a wireless control device.
In regard to claim 62, Harry et al. in view of Maghribi et al. suggest the invention as claimed including comprising at least four stimulation devices having an arrangement of at least two stimulation devices attached at or near a joint on a part of the a body to be stimulated, and at least two stimulation devices attached near a second joint on a second part of the body to be stimulated (i.e., the embodiment of figures 10A,B that is also depicted in figures 13A,B and 14A,B includes stimulation components 2110 and 2120 of contact 2102A (i.e., comprising 2 stimulators) and stimulation components 2110 and 2120 of contact 2102B (i.e., comprising another 2 stimulators thereby being 4 stimulation devices); figures 13A,B show that the stimulator via contacts pads 2102A and 2102B is capable of being attached near first and second body parts).
Harry et al. is also considered to teach that a control signal sequence is applied to the stimulation devices either simultaneously or in a coordinated manner so a user can receive stimulation at the multiple joints on a part of the body (para 76, 88, 96, and 98, Harry et al. teaches that the stimulation provided by stimulators 2110 and 2120 may be provided simultaneously, which is considered to comprise a synchronized manner).
However, Harry et al. does not teach that the control signal is delivered wirelessly. Gesotti teaches that the system comprises a user device wirelessly connected to the stimulation devices and configured to display monitoring data and/or to transmit instructions to the controller to generate a control signal (para 37, display and control panel 116 which may be wirelessly controlled via control interface 106; para 90, in one embodiment, the stimulators are controlled by a wireless link adjusting parameters and synchronizing stimulation). Modification of controller in Harry et al. to comprise a wirelessly connected device to the stimulators would provide the advantage of reducing bulk worn by the patient when using the device and since Gesotti explicitly show that the stimulation parameters may be adjusted and synchronized using a wireless control device.
Claim(s) 51 and 53 is/are rejected under 35 U.S.C. 103 as being unpatentable over Harry et al. (US Publication no. 2008/0077192) and Maghribi et al. (US Publication no. 2004/0243204) in view of Gesotti (US Publication no. 2004/0088025 – previously cited), further in view of Chahine et al. (US Publication no. 2020/0367823 – hereinafter Chahine ‘823 – previously cited) and Longinotti-Buitoni et al. (US Publication no. 2017/0196513 – previously cited).
In regard to claim 51, Harry et al. in view of Maghribi et al. and Gesotti are considered to substantially suggest the invention as claimed, however does not teach the at least one sensor is configured to detect a contact pressure at the interface between the flexible substrate and skin of the subject, the at least one sensor is selected from the group consisting of a pressure sensor and a motion sensor, and monitoring data is stored in a database. Chahine ‘823 discloses wearable sensing garment similar to those of Gesotti and Chahine et al., wherein Chahine ‘823 includes a sensor platform incorporating pressure sensors 41 for detecting the skin contact pressure at the interface between the flexible substrate and skin of the subject (para 48). Modification of the cited prior art to include a pressure sensor to detect a contact pressure at the interface between the flexible substrate and skin of the subject is considered to have been obvious to one of ordinary skill in the art at the time of filing since Chahine ‘823 explicitly teaches this sensor for obtaining feedback to regulate the electrical stimulation applied by the garment.
Harry et al. in view of Gesotti and Chahine ‘823 are considered to substantially suggest the invention as claimed, however does not teach the sensor data is stored in a database. Longinotti-Buitoni et al. teaches that once the sensor module collects the data, the sensor module may store, analyze, or transmit the data (para 51).
Modification of the cited prior art to store sensor data is considered to have been obvious to one of ordinary skill in the art at the time of filing since Longinotti-Buitoni et al. explicitly teaches this capability.
In regard to claim 53, Gesotti teaches that motion sensor data may be used to reduce tremor activity and improve gait (para 30, 17), which is considered to suggest that the sensors obtain information related to these indications. Additionally, Longinotti-Buitoni et al. teaches that the body sensor of the wearable garment may sense information related to speed, cadence, movement, velocity, acceleration, etc (para 32). It is considered to have been obvious to one of ordinary skill in the art at the time of filing to features related to movement as feedback for treatment that aids movement of a user. All of the other recited indications are considered to comprise obvious alternative equivalents for detecting impact of treating motion.
Claim(s) 54-56 is/are rejected under 35 U.S.C. 103 as being unpatentable over Harry et al. (US Publication no. 2008/0077192) and Maghribi et al. (US Publication no. 2004/0243204) in view of Gesotti (US Publication no. 2004/0088025 – previously cited), Chahine et al. (US Publication no. 2020/0367823 – hereinafter Chahine ‘823 – previously cited) and Longinotti-Buitoni et al. (US Publication no. 2017/0196513 – previously cited), further in view of Omid-Zohoor et al. (US Publication no. 2019/0224528 – previously cited).
In regard to claim 54, Harry et al. in view of Maghribi et al., Gesotti, Chahine ‘823 and Longinotti-Buitoni et al. suggest the invention as claimed, however does not teach that he device further comprises a processor configured to compare the obtained monitoring data with pre-determined movement information. Omid-Zohoor et al. describes a system and method for analyzing and improving the performance of a body motion by acquiring sensor data to compare with a pre-determined movement information (para 18 and 42, the sensor data may be compared with data in a database that includes expert or standard performance data). Therefore, modification of the cited prior art to configure the processor to compare the obtained monitoring data with pre-determined movement information is considered to have been obvious to one of ordinary skill in the art at the time of filing since Omid-Zohoor et al. explicitly teaches that this allows for deviations in motion from pre-defined benchmarks to be detected to optimize treatment parameters.
In regard to claim 55, Omid-Zohoor et al. explicitly teaches that the pre-defined movement information may be historical movement data (para 18, the user’s own prior test performance data).
In regard to claim 56, in Omid-Zohoor et al., the processor and sensors are also configured to determine a control signal upon determining that a desired movement has not occurred (para 155, sensors are positioned on the critical points of the anatomy to provide motion data sufficient to define initial positions and range of motion, which is considered to suggest that the sensors therein can be used to indicate if desired or undesired motions have or have not occurred).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/BRIAN T GEDEON/Primary Examiner, Art Unit 3796 27 March 2026