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 .
Response to Amendments
The Amendment filed 10/27/2025 has been entered. Claims 1-2, 4-7, 9, and 20-21 were amended, claims 3, 8, 10-19, and 22-34 were canceled, and claims 35-38 were new. Thus, claims 1-2, 4-7, 9, 20-21, and 35-38 are pending in the application.
Claim Objections
Claims 1, 21, 35, and 37 are objected to because of the following informalities:
Claim 1 recites, “guiding target movement” in lines 1-2, and is suggested to read --guiding a target movement-- in order to ensure proper antecedent basis.
Claim 1 recites, “to the body” in line 17, and is suggested to read --on the body-- in order to be grammatically correct.
Claim 1 recites, “perpendicular” in line 19, and is suggested to read --perpendicularly-- in order to be grammatically correct.
Claim 21 recites, “claims” in line 1, and is suggested to read --claim-- in order to be grammatically correct.
Claim 35 recites, “guiding target movement” in line 1, and is suggested to read --guiding a target movement-- in order to ensure proper antecedent basis.
Claim 35 recites, “the control unit” in line 9, and is suggested to read --the at least one control unit-- in order to more clearly reference how this limitation was originally claimed.
Claim 35 recites, “network” in line 10, and is suggested to read --network of stimulators-- in order to more clearly reference how this limitation was originally claimed.
Claim 35 recites, “signals a peripheral” in lines 17-18, and is suggested to read --signals of a peripheral-- in order to be grammatically correct.
Claim 37 recites, “guiding target movement” in line 1, and is suggested to read --guiding a target movement-- in order to ensure proper antecedent basis.
Claim 37 recites, “the control unit” in line 7, and is suggested to read --the at least one control unit-- in order to more clearly reference how this limitation was originally claimed.
Appropriate correction is required.
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.
Claims 1-2, 4-7, 9, 20-21, and 35-38 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 1, the limitation "the intended target movement" in line 12 is confusing, as it is unclear whether this limitation is meant to be the same as or different from the “target movement” claimed in line 2.
Regarding claim 2, the limitations "a first layer of rubber” in line 3 and “a second layer of rubber material” in line 5 are confusing, as it is unclear whether these limitations are meant to be the same as or different from the “rubber material” recited in claim 1.
Regarding claim 7, the limitation “it” in line 5 is confusing, as it is unclear as to what limitation is being referenced.
Regarding claim 20, the term “if” in line 31 is confusing, as it is unclear whether the limitations following that term are required for the claimed invention. The Examiner suggests using claim language such as --when-- instead to avoid indefiniteness. Moreover, the limitations "a generated control signal” in lines 26-27 and “stimulus control signals” in line 32 are confusing, as it is unclear whether these limitations are meant to be the same as or different from the limitation of “generate a control signal…of stimulators” claimed in lines 12-14. Furthermore, the limitation "the intended target movement" in line 33 is confusing, as it is unclear whether this limitation is meant to be the same as or different from the “target movement” claimed in line 10.
Regarding claim 35, the limitations “such as” in lines 2 and 3 are confusing, as it is unclear whether the following limitations are required or not for the claimed invention, Moreover, the phrase "or the like" in line 3 renders the claim indefinite because the claim includes elements not actually disclosed (those encompassed by "or the like"), thereby rendering the scope of the claim(s) unascertainable. See MPEP § 2173.05(d). Furthermore, the limitation "the intended target movement" in lines 14-15 is confusing, as it is unclear whether this limitation is meant to be the same as or different from the “target movement” claimed in line 1.
Regarding claim 36, the limitations “a stimulator” in line 2, “the each stimulator” in line 3, “each stimulator” in line 5, and “the at least one stimulator” in line 7 is confusing, as it is unclear whether these limitations are meant to be the same or different from each other, as well as whether they are meant to be a part of or separate from the “network of stimulators” of claim 35. Furthermore, the limitations "a first layer of rubber” in line 4 and “a second layer of rubber material” in line 6 are confusing, as it is unclear whether these limitations are meant to be the same as or different from the “rubber material” recited in line 2.
Regarding claim 37, the limitation "the intended target movement" in line 11 is confusing, as it is unclear whether this limitation is meant to be the same as or different from the “target movement” claimed in line 1. Moreover, the limitation “matching target movement” in line 17 is confusing, as it is unclear whether this is meant to be the same as “target movement” in line 1, “the intended target movement” in line 11, or a new limitation. Furthermore, the limitation “it” in line 21 is confusing, as it is unclear as the what limitation is being referenced.
Any remaining claims are rejected based on their dependency on a rejected base claim.
Claim Rejections - 35 USC § 102/103
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 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.
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.
Claims 1-2, 4-7, and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Oddson et al. (US 2015/0123802 A1) in view of Jeffrey et al. (US 6,675,743 B1) and Staton et al. (US 2018/0263826 A1), or alternatively over Oddson in view of Olaighin et al. (US 2018/0140842 A1), Jeffrey, and Staton.
Regarding claim 1, as best understood, Oddson discloses a stimulation system adapted to assist guiding target movement of at least part of a body of a user (feedback device that provides stimulation to a wearer based on their balance information; the device can be used to provide stimulation for stance and dynamic activities such as walking, and thereby allow for the user to perform a corrective action with their lower limbs while walking) (Figs. 1-12; abstract; para. [0007]; para. [0052]; claim 1), the system comprising:
at least one stimulator (vibro-tactile array 52/stimulation array 68 have multiple vibrators) (Figs. 5-12; paras. [0067-0068]);
at least one control unit in communication with the at least one stimulator, the control unit configured to generate a control signal to control frequency and amplitude of the at least one stimulator (processing subsystem 54, 66 sends stimulation control signals to the vibro-tactile array 52/stimulation array 68, which can include modulating vibration stimulus amplitude and frequency) (Figs. 5-12; paras. [0067-0068]; para. [0075]; para. [0077]);
and at least one sensor in communication with the at least one control unit, the at least one sensor configured to monitor parameters related to the target movement and determine the intended target movement being generated by a central nervous system of the user (processing subsystem 54, 66 communicates with force sensing resistors 50/force pressure sensor array 62/bi-axial goniometer 64, which receive balance information; the wearer would be intending to maintain their balance during their movements, thus so their central nervous system attempt that effect, with the resulting movement being sensed by the sensors) (Figs. 5-12; para. [0052]; paras. [0067-0068]),
wherein the control signal is generated on the basis of the intended target movement (processing subsystem 54, 66 sends stimulation control signals to the vibro-tactile array 52/stimulation array 68 based on balance information from force sensing resistors 50/force pressure sensor array 62/bi-axial goniometer 64, to help the wearer maintain their intended balance) (Figs. 5-12; paras. [0067-0068]), and
wherein the at least one stimulator is adapted to be disposed directly or indirectly to the body in a predefined location based on an area of the body to which stimulation is to be provided (vibro-tactile array 52/stimulation array 68 is on the leg, wherein each vibrator in the array is at a front, back, or side of the leg to stimulate that specific portion of the leg) (Figs. 5-12; paras. [0067-0068]; paras. [0070-0073]) and configured to provide stimulation of a peripheral nervous system of the user by moving at a high frequency relative to the skin surface to assist directing the part of the body to achieve the intended target movement (vibro-tactile array 52/stimulation array 68 may be in contact with sensory neurons or nerves; frequency of applied vibration is high enough to be felt during typical wearer movements, wherein the frequency would be felt on the wearer’s leg skin and used to help the wearer move to maintain their intended balance) (Figs. 5-12; para. [0052]; paras. [0067-0068]; para. [0075]; para. [0091]).
Alternatively, if Oddson is not seen as disclosing the at least one sensor configured to determine the intended target movement being generated by a central nervous system of the user, Olaighin teaches a gait management apparatus that applies stimulation (Olaighin; abstract) wherein the at least one sensor is configured to determine the intended target movement being generated by a central nervous system of the user (controller has sensors to sense when there the patient is walking or has an intention to walk; the central nervous system, or CNS, of the patient is what generates the natural motor response of walking) (Olaighin; abstract; para. [0027]; para. [0031]; para. [0114]; para. [0207]).
Therefore, 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 Oddson at least one sensor such that the at least one sensor is configured to determine the intended target movement being generated by a central nervous system of the user, as taught by Olaighin, for the purpose of enabling the system to cue the wearer only when they are not seated, standing still, or lying down (Olaighin; paras. [0030-0031]), thereby helping to avoid pointless cueing and to conserve power.
Oddson does not disclose the at least one stimulator received within a sheath of rubber material, wherein the sheath effectively holds the stimulator in place to allow the stimulator to move and vibrate effectively with a desired amount of tension.
However, Jeffrey teaches a vibrator blanket (Jeffrey; abstract) wherein the at least one stimulator is received within a sheath of rubber material, wherein the sheath effectively holds the stimulator in place to allow the stimulator to move and vibrate effectively with a desired amount of tension (vibrator motor 17 fit into a boot 20 made of synthetic rubber; as Jeffrey teaches the structure as claimed, the vibrator motor 17 would thus be able function to vibrate effectively with a desired amount of tension as claimed) (Jeffrey; Figs. 3A-3B; col. 3, lines 56-67).
Therefore, 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 Oddson at least one stimulator such that the at least one stimulator is received within a sheath of rubber material, wherein the sheath effectively holds the stimulator in place to allow the stimulator to move and vibrate effectively with a desired amount of tension, as taught by Jeffrey, for the purpose of enabling the stimulators or vibrators to be removably secured (Jeffrey; col. 3, lines 56-62).
Oddson does not disclose wherein the at least one stimulator is configured to provide stimulation of a peripheral nervous system of the user by moving both laterally and perpendicular within the sheath.
However, Oddson does disclose lateral or perpendicular vibration movements (vibrator frequency in the mediolateral direction and anteroposterior direction) (Oddson; para. [0052]), although it is silent as to whether both movements can be performed by a same vibrator. Thus, Staton teaches a wearable device to provide vibration therapy (Staton; abstract; para. [0072]) wherein the at least one stimulator is configured to provide stimulation of a peripheral nervous system of the user by moving both laterally and perpendicular (vibrations in vibration therapy are applied to a part of the patient’s body, and therefore would stimulate their peripheral nervous system; vibrations can occur in the vertical z-direction, lateral y-direction, and/or the longitudinal x-direction) (Staton; para. [0072]).
Therefore, 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 Oddson at least one stimulator such that the at least one stimulator is configured to provide stimulation of a peripheral nervous system of the user by moving both laterally and perpendicular, as taught by Staton, for the purpose of helping to improve the effectiveness of treatment (Staton; para. [0072]).
With this modification, the modified Oddson would thus teach wherein the at least one stimulator is configured to move both laterally and perpendicular within the sheath (Oddson vibrators of the vibro-tactile array 52/stimulation array 68 would be inside a Jeffrey sheath or boot 20 and would move in x, y, and/or z directions as taught by Staton) (Oddson, Figs. 5-12, paras. [0067-0068]; Jeffrey, Figs. 3A-3B, col. 3 lines 56-67; Staton, para. [0072]).
Regarding claim 2, as best understood, the modified Oddson teaches wherein the sheath includes a first layer of rubber fixedly attached to a textile or fabric material (synthetic rubber boot 20 has a mount 22, which would fixedly attach to the under-side blanket 12) (Jeffrey; Figs. 3A-4; col. 3, lines 56-67), and wherein the at least one stimulator is sandwiched between the first layer and a second layer of rubber material (vibrator motor 17 is between the mount 22 of boot 20 and the cylindrical portion of boot 20) (Jeffrey; Figs. 3A-4; col. 3, lines 56-67), and wherein the textile or fabric material is adapted to fix the location of the at least one stimulator relative to the body (vibrators of the stimulation array can be in a stocking, and the vibrators are located at the front, back, and both sides of the leg) (Oddson; Figs. 5-12; paras. [0067-0068]; para. [0080]).
Regarding claim 4, the modified Oddson teaches wherein the at least one stimulator is included in a plurality of stimulators forming a network of stimulators (vibrators are in vibro-tactile array 52/stimulation array 68) (Oddson; Figs. 5-12; paras. [0067-0068]), wherein each of the plurality of stimulators is disposed within a sheath (each Oddson vibrator would be inside its own Jeffrey sheath or boot 20) (Oddson, Figs. 5-12, paras. [0067-0068]; Jeffrey, Figs. 3A-3B, col. 3 lines 56-67) in a predefined location relative to the part of the body to which stimulation is to be provided to achieve the intended target movement (vibro-tactile array 52/stimulation array 68 is on the leg, wherein each vibrator in the array is at a front, back, or side of the leg to stimulate that specific portion of the leg; frequency of applied vibration is high enough to be felt during typical wearer movements, wherein the frequency would be felt on the wearer’s leg skin and used to help the wearer maintain their intended balance during those movements) (Oddson; Figs. 5-12; para. [0052]; paras. [0067-0068]; paras. [0070-0073]; para. [0075]).
Regarding claim 5, the modified Oddson teaches wherein the control signal is generated when at least one pre-defined criteria is met (stimulus is provided to a user when the center of pressure 88, 98 is outside the dead zone 86, and so the vibrators would get the control signal to provide vibration stimulus then) (Oddson; Figs. 8-12; paras. [0070-0074]).
Regarding claim 6, the modified Oddson teaches wherein the control signal further controls timing, synchronisation, duty cycle, location and intensity to coordinate the stimulation provided by the plurality of stimulators (in Oddson, when the vibrators vibrate, which vibrators vibrate, where on the leg the vibrators vibrate, and what frequency the vibrators vibrate at are all controlled; Olaighin modulates the stimulus in 10 second cycles when the patient is detected to be walking) (Oddson, Figs. 8-12, paras. [0070-0075]; Olaighin, paras. [0235-0241]) that reinforce target neuromuscular signals guiding muscle contractions improving target movements within and between limbs and repetitions for the user and thereby minimising excessive conscious movements (the balance information provided by the system is integrated into a patient’s unconscious postural control, i.e. the neurological signals controlling muscle contraction in the legs for balance during repetitive dynamic activities such as walking, thereby eliminating the need for conscious balancing effort) (Oddson; para. [0008]; para. [0052]).
Regarding claim 7, as best understood, the modified Oddson teaches wherein the control signal to the plurality of stimulators is determined using feedback from the plurality of sensors so that the duty cycle of the control signal is increased or decreased until it matches the target movement of the user (in Oddson, when the center of pressure 88, 98 is outside of the dead zone 86 as sensed by the force sensing resistors 50/force pressure sensor array 62/bi-axial goniometer 64, a signal is given to the vibrators in the stimulation array 52, 68, and when the center of pressure 88, 98 is inside of the dead zone 86, i.e. the target balance movement is achieved, there is no more applied vibration stimulus; Olaighin modulates the stimulus in 10 second cycles when the patient is detected to be walking) (Oddson, Figs. 5-12, paras. [0067-0068], paras. [0070-0075]; Olaighin, paras. [0235-0241]).
Regarding claim 9, the modified Oddson teaches wherein the at least one sensor is included in a plurality of sensors (force sensing resistors 50/force pressure sensor array 62/bi-axial goniometer 64 receive balance information) (Oddson; Figs. 5-12; paras. [0067-0068]), wherein the plurality of sensors and the plurality of stimulators are incorporated into a tight fitting garment made from the fabric or textile, which allows the plurality of sensors and the plurality of stimulators to be held in place against the skin (sensor array incorporated in a stocking, and so the sensor array would be held in place against the user’s leg/foot skin) (Oddson; Figs. 5-12; para. [0080]).
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Oddson in view of Jeffrey and Olaighin.
Regarding claim 20, as best understood, Oddson discloses a method of guiding coordinated movement of limbs of a user (feedback device that provides stimulation to a wearer based on their balance information; the device can be used to provide stimulation for stance and dynamic activities such as walking, and thereby allow for the user to perform a corrective action with their lower limbs while walking) (Figs. 1-12; abstract; para. [0007]; para. [0052]; claim 1), comprising the steps of:
(a) providing a network of stimulators woven into a tightly fitting garment to be worn by the user, and wherein the network of stimulators are disposed in a predefined location relative to a part of the limb to which stimulation is to be provided to achieve a target movement (vibro-tactile array 52/stimulation array 68 is in a stocking on the leg, wherein each vibrator in the array is at a front, back, or side of the leg to stimulate that specific portion of the leg to help the wearer maintain their intended balance during dynamic activities such as walking) (Figs. 5-12; para. [0052]; paras. [0067-0068]; paras. [0070-0073]; para. [0080]);
(b) providing at least one control unit in communication with the network of stimulators, the control unit configured to generate a control signal to control frequency and amplitude of the network of stimulators (processing subsystem 54, 66 sends stimulation control signals to the vibro-tactile array 52/stimulation array 68, which can include modulating vibration stimulus amplitude and frequency) (Figs. 5-12; paras. [0067-0068]; para. [0075]; para. [0077]);
(c) providing a network of sensors in communication with the at least one control unit, the network of sensors being incorporated into the tightly fitting garment (processing subsystem 54, 66 communicates with force sensing resistors 50/force pressure sensor array 62/bi-axial goniometer 64 receive balance information; sensor array incorporated in a stocking, and so the sensor array would be held in place against the user’s leg/foot skin) (Figs. 5-12; paras. [0067-0068]; para. [0080]);
(d) providing a stimulus to the limbs through the network of stimulators to guide the target movement of the limbs (vibro-tactile array 52/stimulation array 68 give a wearer vibration feedback to the legs on when to perform a corrective action) (Figs. 5-12; paras. [0067-0068]; claim 1);
(e) receiving data related to at least one parameter relating to the target movement from at least one sensor in the network of sensors (force sensing resistors 50/force pressure sensor array 62/bi-axial goniometer 64 receive balance information) (Figs. 5-12; paras. [0067-0068]);
(f) comparing the at least one parameter relating to the target movement with at least one pre-defined criteria (the center of pressure 88, 98 location is compared to the location of the dead zone 86) (Figs. 8-12; para. [0063]; paras. [0070-0074]);
(g) providing an adjusted stimulus to the limbs through a generated control signal when the at least one parameter does not meet the pre-defined criteria, wherein the adjusted stimulus is generated based on the received data related to the target movement and historical data (the system is meant to train a wearer’s unconscious postural control system, and so would give be used to give multiple different stimulations over time; a next vibration stimulus applied by the processing subsystem 54, 66 to the wearer’s body can be adjusted for a certain number of vibrators used, the locations of the vibrators used, and the frequency of the applied vibrations based on where the center of pressure 88, 98 is outside of the dead zone 86; this applied vibration is based on balance information sensed instantaneously and over time) (Figs. 5-12; para. [0005]; paras. [0070-0074]; claims 1, 3-5); and
(h) ceasing stimulation if the parameter meets the pre-defined criteria (when the center of pressure 88, 98 is inside of the dead zone 86, there is no more applied vibration stimulus) (Figs. 8-12; para. [0070]),
wherein stimulus control signals are coordinated to link the limbs in a cycle matching the intended target movement that reinforce target neuromuscular signals guiding muscle contractions, whereby improved coordination within and between the limbs is achieved by the user (applied vibrations from the vibrators are controlled to coordinate the legs during the cyclical activity of walking, to help the wearer to improve their balance by indicating when they should be adjusting their muscles, which would be done via the wearer’s neuromuscular signals, to achieve the normal walking movement) (Figs. 5-12; para. [0005]; para. [0052]; para. [0067]; paras. [0070-0076]).
Oddson does not disclose wherein each stimulator of the network of stimulators is received in a sheath of rubber material adapted to hold each stimulator in place so as to enable each stimulator to move and vibrate effectively with a desired amount of tension.
However, Jeffrey teaches a vibrator blanket (Jeffrey; abstract) wherein each stimulator of the network of stimulators is received in a sheath of rubber material adapted to hold each stimulator in place so as to enable each stimulator to move and vibrate effectively with a desired amount of tension (vibrator motor 17 fit into a boot 20 made of synthetic rubber; as Jeffrey teaches the structure as claimed, the vibrator motor 17 would thus be able function to vibrate effectively with a desired amount of tension as claimed) (Jeffrey; Figs. 3A-3B; col. 3, lines 56-67).
Therefore, 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 Oddson stimulators such that each stimulator of the network of stimulators is received in a sheath of rubber material adapted to hold each stimulator in place so as to enable each stimulator to move and vibrate effectively with a desired amount of tension, as taught by Jeffrey, for the purpose of enabling the stimulators or vibrators to be removably secured (Jeffrey; col. 3, lines 56-62).
Oddson does not disclose stimulus control signals are coordinated to link the limbs in a predictable duty cycle matching the intended target movement.
However, Olaighin teaches a gait management apparatus that applies stimulation (Olaighin; abstract) wherein stimulus control signals are coordinated to link the limbs in a predictable duty cycle matching the intended target movement (cyclically, every 10 seconds, the controller modulates the stimulus to the legs to help the wearer coordinate leg movements to walk more normally, minimizing FOG incidence) (Olaighin; abstract; para. [0027]; para. [0031]; para. [0207]; paras. [0235-0241]).
Therefore, 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 Oddson stimulus control signals such that the stimulus control signals are coordinated to link the limbs in a predictable duty cycle matching the intended target movement, as taught by Olaighin, for the purpose of enabling the system to cue the wearer only when they are not seated, standing still, or lying down (Olaighin; paras. [0030-0031]), thereby helping to avoid pointless cueing and to conserve power.
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Oddson in view of Jeffrey and Olaighin as applied to claim 20 above, and further in view of Brokaw et al. (US 9,974,478 B1).
Regarding claim 21, the modified Oddson teaches the invention as previously claimed, but does not teach further comprising the steps of: updating at least one stimulation setting based on the received data and the target movement to define at least one updated stimulation setting; and generating an optimised control signal with the updated stimulation setting to provide an adjusted stimulus to the limbs to guide the limbs towards achieving the intended target movement.
However, Brokaw teaches a system and method for helping subjects improve safety and efficacy of their movements (Brokaw; abstract) including updating at least one stimulation setting based on the received data and the target movement to define at least one updated stimulation setting; and generating an optimised control signal with the updated stimulation setting to provide an adjusted stimulus to the limbs to guide the limbs towards achieving the intended target movement (cues or stimuli are adaptive; if the subject does not notice or comprehend the stimulus, the system would recognize that the subject did not correct the undesirable movement, and so the intensity, duration, or frequency of the stimulus can be subsequently increased; an increased stimulus would then be applied to the subject via an output signal from a processor to apply the adapted stimulus to the subject to get the subject to correct the undesirable movement) (Brokaw; col. 44, lines 10-42; col. 50, lines 20-33).
Therefore, 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 Oddson method to include updating at least one stimulation setting based on the received data and the target movement to define at least one updated stimulation setting; and generating an optimised control signal with the updated stimulation setting to provide an adjusted stimulus to the limbs to guide the limbs towards achieving the intended target movement., as taught by Brokaw, for the purpose of helping the user to notice a cue or stimulus after missing one, particularly in urgent situations, and thereby help the user to correct an undesirable movement (Brokaw; col. 44, lines 10-42).
Claim 35 is rejected under 35 U.S.C. 102(a)(1) as anticipated by Oddson or, in the alternative, under 35 U.S.C. 103 as obvious over Oddson in view of Olaighin.
Regarding claim 35, as best understood, Oddson discloses a device adapted to be worn by a user to assist guiding target movement of at least part of a body such as arms and legs of the user (feedback device that provides stimulation to a wearer based on their balance information; the device can be used to provide stimulation for stance and dynamic activities such as walking, and thereby allow for the user to perform a corrective action with their legs while walking) (Figs. 1-12; abstract; para. [0007]; para. [0052]; claim 1), the device comprising:
a fabric or textile substrate such as a sock having a network of stimulators fixed on the fabric or textile, wherein the textile or fabric substrate is adapted to fix the location of the network of stimulators relative to the body in a predefined location based on an area of the body to which stimulation is to be provided (vibrators of the stimulation array can be in a stocking, and the vibrators are located at the front, back, and both sides of the leg) (Figs. 5-12; paras. [0067-0068]; para. [0080]);
at least one control unit in communication with the network of stimulators, the control unit configured to generate a control signal to control frequency and amplitude of each stimulator in the network (processing subsystem 54, 66 sends stimulation control signals to the vibro-tactile array 52/stimulation array 68, which can include modulating vibration stimulus amplitude and frequency) (Figs. 5-12; paras. [0067-0068]; para. [0075]; para. [0077]); and
a network of sensors fixed to the fabric or textile substrate in communication with the at least one control unit, the network of sensors being held to the body by the fabric or textile substrate at predetermined locations of the body and configured to monitor parameters related to the target movement and determine the intended target movement being generated by a central nervous system of the user (sensor array incorporated in a stocking, and so the sensor array would be held in place against the user under the soles of their feet; processing subsystem 54, 66 communicates with the sensor array of force sensing resistors 50/force pressure sensor array 62/bi-axial goniometer 64, which receive balance information; the wearer would be intending to maintain their balance during their movements, thus so their central nervous system attempt that effect, with the resulting movement being sensed by the sensors) (Figs. 5-12; para. [0052]; paras. [0067-0068]; para. [0080]),
wherein the control signal to the network of stimulators is synchronised based on feedback from received monitored parameters to reinforce target neuromuscular signals a peripheral nervous system of the user to improve the target movement (processing subsystem 54, 66 sends stimulation control signals to the vibro-tactile array 52/stimulation array 68 based on balance information from force sensing resistors 50/force pressure sensor array 62/bi-axial goniometer 64, to help the wearer improve their balance; more than one vibrator may be used to provide stimulus at one time when needed, such as seen in Fig. 11; stimulation array may be in contact with sensory nerves) (Figs. 5-12; paras. [0067-0068]; para. [0073]; para. [0091]).
Alternatively, if Oddson is not seen as disclosing the network of sensors configured to determine the intended target movement being generated by a central nervous system of the user, Olaighin teaches a gait management apparatus that applies stimulation (Olaighin; abstract) wherein the network of sensors configured to determine the intended target movement being generated by a central nervous system of the user (controller has sensors to sense when there the patient is walking or has an intention to walk; the central nervous system, or CNS, of the patient is what generates the natural motor response of walking) (Olaighin; abstract; para. [0027]; para. [0031]; para. [0114]; para. [0207]).
Therefore, 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 Oddson network of sensors such that the network of sensors configured to determine the intended target movement being generated by a central nervous system of the user, as taught by Olaighin, for the purpose of enabling the system to cue the wearer only when they are not seated, standing still, or lying down (Olaighin; paras. [0030-0031]), thereby helping to avoid pointless cueing and to conserve power.
Claim 36 is rejected under 35 U.S.C. 103 as being unpatentable over Oddson in view of Olaighin as applied to claim 35 above, and further in view of Jeffrey.
Regarding claim 36, as best understood, the modified Oddson teaches the invention as previously claimed, including wherein the textile or fabric material is adapted to fix the location of the at least one stimulator relative to the body (vibrators of the stimulation array can be in a stocking, and the vibrators are located at the front, back, and both sides of the leg) (Oddson; Figs. 5-12; paras. [0067-0068]; para. [0080]), but does not teach the network of stimulators is each received within a sheath of rubber material, wherein each sheath effectively holds a stimulator in place to allow the each stimulator to move and vibrate effectively with a desired amount of tension; and wherein each of the sheaths includes a first layer of rubber fixedly attached to the textile or fabric substrate, wherein each stimulator is sandwiched between the first layer and a second layer of rubber material.
However, Jeffrey teaches a vibrator blanket (Jeffrey; abstract) wherein the network of stimulators is each received within a sheath of rubber material, wherein each sheath effectively holds a stimulator in place to allow the each stimulator to move and vibrate effectively with a desired amount of tension (vibrator motor 17 fit into a boot 20 made of synthetic rubber; as Jeffrey teaches the structure as claimed, the vibrator motor 17 would thus be able function to vibrate effectively with a desired amount of tension as claimed) (Jeffrey; Figs. 3A-3B; col. 3, lines 56-67); and wherein each of the sheaths includes a first layer of rubber fixedly attached to the textile or fabric substrate (synthetic rubber boot 20 has a mount 22, which would fixedly attach to the under-side blanket 12) (Jeffrey; Figs. 3A-4; col. 3, lines 56-67), wherein each stimulator is sandwiched between the first layer and a second layer of rubber material (vibrator motor 17 is between the mount 22 of boot 20 and the cylindrical portion of boot 20) (Jeffrey; Figs. 3A-4; col. 3, lines 56-67).
Therefore, 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 Oddson network of stimulators to include sheaths such that the network of stimulators is each received within a sheath of rubber material, wherein each sheath effectively holds a stimulator in place to allow the each stimulator to move and vibrate effectively with a desired amount of tension; and wherein each of the sheaths includes a first layer of rubber fixedly attached to the textile or fabric substrate, wherein each stimulator is sandwiched between the first layer and a second layer of rubber material, as taught by Jeffrey, for the purpose of enabling the stimulators or vibrators to be removably secured (Jeffrey; col. 3, lines 56-62).
Claims 37-38 are rejected under 35 U.S.C. 103 as being unpatentable over Oddson in view of Olaighin.
Regarding claim 37, as best understood, Oddson discloses a stimulation system adapted to assist guiding target movement of at least part of a body (feedback device that provides stimulation to a wearer based on their balance information; the device can be used to provide stimulation for stance and dynamic activities such as walking, and thereby allow for the user to perform a corrective action with their lower limbs while walking) (Figs. 1-12; abstract; para. [0007]; para. [0052]; claim 1), the system comprising:
a network of stimulators adapted to be disposed directly or indirectly to the body in a predefined location based on an area of the body to which stimulation is to be provided (vibro-tactile array 52/stimulation array 68 is in a stocking on the leg, wherein each vibrator in the array is at a front, back, or side of the leg to stimulate that specific portion of the leg) (Figs. 5-12; para. [0052]; paras. [0067-0068]; paras. [0070-0073]; para. [0080]);
at least one control unit in communication with the network of stimulators, the control unit configured to generate a control signal to control the network of stimulators (processing subsystem 54, 66 sends stimulation control signals to the vibro-tactile array 52/stimulation array 68, which can include modulating vibration stimulus amplitude and frequency) (Figs. 5-12; paras. [0067-0068]; para. [0075]; para. [0077]); and
a plurality of sensors in communication with the at least one control unit, the plurality of sensors configured to monitor parameters related to the target movement and determine the intended target movement being generated by a central nervous system of a user wherein the control signal is generated on the basis of the intended target movement (processing subsystem 54, 66 communicates with force sensing resistors 50/force pressure sensor array 62/bi-axial goniometer 64, which receive balance information; the wearer would be intending to maintain their balance during their movements, thus so their central nervous system attempt that effect, with the resulting movement being sensed by the sensors; the applied vibration is based on the sensed information) (Figs. 5-12; para. [0052]; paras. [0067-0068]),
wherein the network of stimulators is configured to provide stimulation of a peripheral nervous system of the user and wherein stimulus control signals are coordinated to link movement of the at least part of the body in a cycle matching target movement that reinforce target neuromuscular signals guiding muscle contractions (stimulation array vibrators can be in contact with sensory nerves; stimulation array vibrators are controlled to coordinate the legs during the cyclical activity of walking, to help the wearer to improve their balance by indicating when they should be adjusting their muscles, which would be done via the wearer’s neuromuscular signals, to achieve the normal walking movement) (Figs. 5-12; para. [0005]; para. [0052]; para. [0067]; paras. [0070-0076]; para. [0091]); and
wherein timing of the control signal to the network of stimulators is determined using feedback from the plurality of sensors so that the cycle of the control signal is increased or decreased until it matches the intended target movement of the user (when the vibrators vibrate is controlled based on when the wearer’s center of pressure is sensed to be outside of a dead zone 86; higher or lower frequencies of vibration can be used until the wearer’s center of pressure moves inside the dead zone 86, during which there would be no vibration applied) (Figs. 8-12; paras. [0070-0075]).
Oddson does not disclose stimulus control signals are coordinated to link movement of the at least part of the body in a predictable duty cycle matching target movement.
However, Olaighin teaches a gait management apparatus that applies stimulation (Olaighin; abstract) stimulus control signals are coordinated to link movement of the at least part of the body in a predictable duty cycle matching target movement (cyclically, every 10 seconds, the controller modulates the stimulus to the legs to help the wearer coordinate leg movements to walk more normally, minimizing FOG incidence) (Olaighin; abstract; para. [0027]; para. [0031]; para. [0207]; paras. [0235-0241]).
Therefore, 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 Oddson stimulus control signals such that stimulus control signals are coordinated to link movement of the at least part of the body in a predictable duty cycle matching target movement, as taught by Olaighin, for the purpose of enabling the system to cue the wearer only when they are not seated, standing still, or lying down (Olaighin; paras. [0030-0031]), thereby helping to avoid pointless cueing and to conserve power.
Regarding claim 38, the modified Oddson teaches the invention as previously claimed, but does not teach wherein the network of stimulators comprise electrical stimulators adapted to be held against skin of the user (feedback from stimulation array held against the leg/foot skin of the user can be electrotactile) (Oddson; Figs. 5-12; para. [0088]; claim 1).
Response to Arguments
Applicant's arguments filed 10/27/2025 have been fully considered but they are not persuasive.
On page 12 in the “Drawings” section of the Applicant’s remarks, the Applicant argues that the drawings have been amended to overcome the drawing objections of the previous office action. The Examiner agrees, and has thus withdrawn those drawing objections.
On page 13 in the “Claim Objections” section of the Applicant’s remarks, the Applicant argues that the claims have been amended to overcome the claim objections of the previous office action. The Examiner agrees, and has thus withdrawn those claim objections. However, the newly amended claims have raised new claim objections as detailed above.
On page 13 in the “Claim Rejections Under 35 U.S.C. 112” section of the Applicant’s remarks, the Applicant argues that the claims have been amended to overcome the 35 U.S.C. 112(b) rejections of the previous office action. The Examiner partially agrees, and has thus withdrawn those 35 U.S.C. 112(b) rejections which were addressed. However, the 35 U.S.C. 112(b) rejections which were not addressed are being maintained, along with new 35 U.S.C. 112(b) rejections raised by the newly amended claims as detailed above.
On page 19 in the last paragraph of the Applicant’s remarks, the Applicant argues that the Oddson reference requires a user to consciously think about correcting their movements, and thus cannot be used to teach the Applicant’s claimed invention. However, the Examiner respectfully disagrees. The goal of the Oddson device is that, with practice, a user will be able to use the balance information, i.e. vibration feedback, from the device to unconsciously control their balance (Oddson; para. [0008]; para. [0076]; para. [0088]). Thus, the Oddson device can still be used to teach the Applicant’s invention as currently claimed.
Applicant’s arguments on pages 20-22 with respect to the newly amended claim 1 have been considered but are moot in view of new grounds of rejection with new additional Olaighin, Jeffrey, and Staton references being used in the current rejection as discussed above.
On page 21 in the third paragraph of the Applicant’s remarks, the Applicant argues that the Oddson reference does not teach monitoring parameters related to the target movement and determining the intended target movement being generated by a user, or providing stimulation to the nervous system to assist directing the part of the body to achieve the intended target movement, thus cannot be used to teach the Applicant’s claimed invention. However, the Examiner respectfully disagrees. Oddson does teach monitoring parameters related to the target movement and determining the intended target movement being generated by a user (force sensing resistors 50/force pressure sensor array 62/bi-axial goniometer 64 receive balance information; the wearer would be intending to maintain their balance during their movements, thus so their central nervous system attempt that effect, with the resulting movement being sensed by the sensors) (Oddson; Figs. 5-12; para. [0052]; paras. [0067-0068]), and providing stimulation to the nervous system to assist directing the part of the body to achieve the intended target movement (vibro-tactile array 52/stimulation array 68 may be in contact with sensory neurons or nerves; frequency of applied vibration is high enough to be felt during typical wearer movements, wherein the frequency would be felt by the wearer and used to help the wearer move to maintain their intended balance during a dynamic activity such as walking) (Oddson; Figs. 5-12; para. [0052]; paras. [0067-0068]; paras. [0070-0075]; para. [0091]). Alternatively, as detailed in the 35 U.S.C. 103 rejection of claim 1, if Oddson is not seen as disclosing determining the intended target movement being generated by a user, Olaighin can teach this limitation (controller has sensors to sense when there the patient is walking or has an intention to walk; the central nervous system, or CNS, of the patient is what generates the natural motor response of walking; the sensed walking or intention to walk activates the cueing actuator to prevent gait dysfunction) (Olaighin; abstract; para. [0027]; para. [0031]; para. [0207]). Thus, the current prior art of record, either Oddson or Oddson in view of Olaighin, can be used to teach the Applicant’s invention as currently claimed.
On page 22 in the “Non-Statutory Double Patenting” section of the Applicant’s remarks, the Applicant argues that the claims have been amended to overcome the double patenting rejections of the previous office action. The Examiner agrees, and has thus withdrawn those double patenting rejections.
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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/JACQUELINE M PINDERSKI/Examiner, Art Unit 3785
/RACHEL T SIPPEL/Primary Examiner, Art Unit 3785
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