DETAILED ACTION
Claims 1-20 are pending and hereby under examination.
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 Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
“sensory stimulation unit” first recited in claim 1;
“processor” first recited in claim 1;
“sensor processing module” first recited in claim 5;
“mobile device” first recited in claim 9; and
“first / second stimulation unit” first recited in claim 17;
The identified structure for the corresponding claim limitations are as follows:
“sensory stimulation unit” is identified as “wherein the at least one sensory stimulation unit comprises at least two stimulators that are actuable to provide stimulation to the patient based on the balance stimulation signals” (paragraph 0096).
“processor configured to” is identified as “the central processor (such as central processor 18) can calculate patient-specific biomechanical model data (including an estimation of the center of mass (“COM”) of the patient), control the system configuration, provide secure storage, and analyze data, or any combination thereof” (Paragraph 0056),
“In certain embodiments, each footpad (such as footpads 40A in footpad units 12A, 12B) can provide foot pressure data used to calculate the center of pressure (“COP”). That is, an exemplary footpad contains pressure sensors positioned at locations corresponding to the anatomical pressure distribution of the plantar surface of the foot. The back sensor covers most of the pressure from the heel of the foot. The outer sensor covers the lateral side of the foot up to the fifth metatarsal heads. The front sensor is located at the ball of the foot between the first and fifth metatarsal heads. The inner sensor is located medial side of the foot up to the first metatarsal head such that the sensor is loaded by both the first metatarsal head and by the surface under the arch. Regardless of the number of pressure sensors and the positioning thereof, the foot pressure amplitude and distribution data from these sensors can be used to estimate the COP of the patient during activities such as standing and walking and the like” (Paragraph 0053),
“one example of IMUs being used to generate an electronic, real-time full-body human model is shown in FIGS. 3A-5B. More specifically, as shown in FIG. 3A, the IMUs 60A, 60B, 60C, 60D, 60E are positioned on the patient in order to track the movement of the patient. More specifically, the IMU 60A is attached to the patient’s right foot or ankle, the IMU 60B is attached to the patient’s left foot or ankle, the IMU 60C is attached to the patient’s right thigh, the IMU 60D is attached to the patient’s left thigh, and the IMU 60E is attached to the patient’s lower back in a fashion similar to that described above with respect to FIG. 1. Thus, the resulting model generated by the IMUs 60A-60E (as positioned in FIG. 3A) is shown in FIG. 3B, which depicts a graphic user interface displaying the human model, including a front view 62 and a side view 64. According to one embodiment, the views 62, 64 of the model can be displayed on a computer, tablet, or mobile device (such as device 22) as discussed elsewhere herein. In FIG. 4A, the patient is walking such that the right leg moves forward in a hip flexion movement with the right leg sensors 60A, 60C tracking that movement such that it is reflected by the movement of the model in FIG. 4B. Further, in FIG. 5A, the patient’s right leg moves into a right knee flexion movement with the right leg sensors 60A, 60B tracking that movement such that it is reflected in the movement of the model in FIG. 5B. Thus, the various sensors 60A-60E make it possible to track all of the standing, walking, and/or running movements of a patient such that the movements can be reflected in the movement of the electronic model in a similar fashion as above” (Paragraph 0059),
“At this point, the collected data is used to calculate the weight distribution and thus the center of gravity of the patient based on the sensor data (block 90). That is, the data from the sensors in the right and left footpads (such as footpads of units 12A, 12B) is collected, combined, and processed by the local processor 20 (and/or the central processor 18) to calculate the patient’s center of gravity at any given time” (Paragraph 0070),
“Once the patient’s weight distribution/center of gravity is calculated, that data is compared to the target weight distribution/center of gravity to identify the difference therebetween (if any) and calculate the stimulation unit activation period based on same (block 92). That is, the difference between the actual weight distribution and the target distribution is first calculated. As a result, the data can be used to track any shift in the center of gravity, including any shift away from a target weight distribution or center of gravity location. That is, any movement of the patient’s weight distribution away from or toward a desired weight distribution/center of gravity can be calculated based on the collected data and the preset target weight distribution/center of gravity. Once the difference calculated, that information is used to determine the activation period of the stimulation unit. In other words, the amount of the difference determines the activation period. For example, the greater the difference, then the farther that the actual center of gravity is from the target center of gravity (the more that the patient has shifted her weight away from the target center of gravity). And the activation period of the stimulation unit is dependent on the distance between the actual center of gravity and the target center of gravity. For example, in one embodiment, the greater the distance, the greater the activation period (and thus the longer the duration and/or the greater the intensity of the stimulus provided to the patient at the stimulation unit). Alternatively, the greater the distance, the shorter the activation period (and thus the greater the number of activations – vibrations, beeps, or the like – over a shorter period of time provided to the patient at the stimulation unit). In any of the embodiments herein, the parameters provided by the system (the default parameters) or the parameters provided by the clinician or other user as described above will be used as part of the calculation to determine the activation period. In one specific exemplary implementation, a predetermine threshold of movement is set in the parameters such that when the patient shifts her weight to one leg or the other by a sufficient amount to cross that threshold, then the calculation triggers activation. In such an embodiment, a target weight distribution/center of gravity range can be set such that the system does not cause the activation of the stimulation units so long as the patient remains within that target range (a “balance deadzone”). Thus, calculations cause activation of the stimulation units only when the threshold beyond the target range is hit and/or surpassed” (Paragraphs 0071-0072).
“sensor processing module” is identified as “Further, in certain embodiments as noted above, each of the motion/angle sensors (such as sensors 14A- 14E) in the system 10 is incorporated into a unit that includes a local processor. Such a unit can be referred to herein as a sensor processing module ("SPM") such that the motion and angle sensors 14A-14E are also SPMs 14A-14E. The SPM can capture IMU data, and provide local sensor fusion functionality and connectivity” (paragraph 0056).
“mobile device” is identified as “In some implementations, an application running on an off-the-shelf mobile device (such as device 22) such as a phone, tablet, or laptop can provide the central processor functionality” (paragraph 0057).
“first / second stimulation unit” is identified as “wherein the at least one sensory stimulation unit comprises a first stimulation unit disposed on a first lower limb or prosthesis of the patient and a second stimulation unit disposed on a second lower limb or prosthesis of the patient” (paragraph 0016) and “wherein the at least one sensory stimulation unit comprises at least two stimulators that are actuable to provide stimulation to the patient based on the balance stimulation signals” (paragraph 0096).
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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 1-20 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 claims 1, 11, and 17, the processor is configured to generate a patient-specific virtual biomechanical model based on the force and/or pressure signals and the motion and/or angle signals to generate an estimated center of pressure and a center of gravity. It is unclear how the centers of gravity/pressure are “generated” from the model. Is there a calculation, algorithm, or equation used from the model? For examination purposes, any calculation of a center of pressure and center of gravity using force/pressure and motion/angle signals will be required to meet the claim. Claims 2-10, 12-16, and 18-20 are also rejected due to their dependence on claims 1, 11, and 17.
Regarding claims 1, 11, and 17, it is unclear how the sensors are “associated” with the lower limbs of the patient. Are the sensors placed, coupled, or attached to the patient in some way? For examination purposes, the claims will be interpreted based on Applicant’s specification paragraph 0059, wherein the sensors are “attached to the patient”.
Regarding claims 2-3 and 12, it is unclear how the force and/or pressure sensor is “associated” with a first pad. Is the sensor placed, coupled, or attached to the pad? For examination purposes, the claims will be interpreted based on Applicant’s specification paragraph 0053, wherein the force/pressure sensor is “disposed within/integral with the footpad”.
Regarding claims 15 and 19, it is unclear how the sensors / sensor processing modules are “associated” with the stimulators. Do the sensors/modules also have a stimulation function (i.e., they are the same element)? Are the sensors/modules connected to each other or are they merely placed near each other? For examination purposes, “associated” will be interpreted such that the sensors measure force/pressure and/or motion/angle data and the stimulators stimulate based on that data.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-6, 8-12, and 16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Czaja (US 20170225033 – cited by Applicant).
Regarding claim 1, Czaja teaches a system for improving sensorimotor function of a patient, the system comprising:
(a) at least one force and/or pressure sensor associated with at least one lower limb or prosthesis of a patient, wherein the at least one force and/or pressure sensor is configured to detect force and/or pressure information relating to the lower limb or prosthesis and transmit force and/or pressure signals based on the force and/or pressure information (Figs. 2-5; Paragraph 0076, “ In addition, to motion processing, two or more force pressure sensors are also embedded in the sole, said pressure sensors record the force applied to the pressure point on the insole”);
(b) at least one motion and/or angle sensor associated with at least one lower limb or prosthesis of a patient, wherein the at least one motion and/or angle sensor is configured to detect motion and/or angle information relating to the lower limb or prosthesis and transmit motion and/or angle signals based on the motion and/or angle information (Figs. 2-5; Paragraph 0085, “The motion processing element 1031, is configured for analysis of motion with 10-degree of freedom comprising several inertial MEMS sensors: a 3D gyroscope; a 3D accelerometer; a 3D magnetometer”);
(c) a processor (Fig. 4, microprocessor 1034) configured to receive the force and/or pressure signals and the motion and/or angle signals, generate a patient-specific virtual biomechanical model based on the force and/or pressure signals and the motion and/or angle signals (Paragraph 0076, wherein the motion data from the MEMS motion processor and the data from the pressure sensors can be combined to determine the phase the skis are in) to generate an estimated center of pressure and a center of gravity (Paragraph 0082, wherein COP is obtained from pressure sensor data; Paragraph 0119, “Based on signal from sensors, using inertia navigation algorithms, application calculates kinematics of the ski trajectory. Then using user parameters, creates biomechanical model of foot/ski interface, and the sensor kinematics is translated to segments kinematics by measuring the position (and timing) of COF”; Paragraphs 0123 and 0134, wherein center of mass is also calculated), and generate balance stimulation signals based on the estimated center of pressure and the center of gravity (Paragraph 0119, wherein the application provides haptic feedback based on the data and COF; Paragraph 0120); and
(d) at least one sensory stimulation unit disposed on at least one lower limb or prosthesis of the patient, wherein the at least one sensory stimulation unit comprises at least two stimulators that are actuable to provide stimulation to the patient based on the balance stimulation signals (Figs 2-5, haptic actuator 1033; Paragraph 0002, “Furthermore, one or more actuators are embedded in the shoe insole to provide haptic feedback to the user foot”).
Regarding claim 2, Czaja further teaches wherein a first of the at least one force and/or pressure sensor is associated with a first pad, wherein the first pad is disposable under a first foot or prosthetic foot of the patient (Figs. 2-5, insole 100 of ski boot 110 with pressure/force sensors 1032; Paragraph 0076, “In addition, to motion processing, two or more force pressure sensors are also embedded in the sole, said pressure sensors record the force applied to the pressure point on the insole”; Paragraph 0050, ski boots).
Regarding claim 3, Czaja further teaches wherein a second of the at least one force and/or pressure sensor is associated with a second pad, wherein the second pad is disposable under a second foot or prosthetic foot of the patient (Figs. 2-5, insole 100 of ski boot 110 with pressure/force sensors 1032; Paragraph 0076, “In addition, to motion processing, two or more force pressure sensors are also embedded in the sole, said pressure sensors record the force applied to the pressure point on the insole”; Paragraph 0050, ski boots).
Regarding claim 4, Czaja further teaches wherein the at least one motion and/or angle sensor comprises five motion and/or angle sensors (Paragraph 0076, wherein one insole comprises a 3-axis accelerometer, 3 axis gyroscope, and 3 axis magnetometer; Paragraph 0085 and Figs. 2-5, motion processing element 1031; Paragraph 0050, wherein the accelerometer/gyroscope/magnetometer are applied to both boots; thus, there are 6 total sensors).
Regarding claim 5, Czaja further teaches wherein each of the five motion and/or angle sensors is an inertial motion unit disposed within a sensor processing module (Paragraph 0085, “The motion processing element 1031, is configured for analysis of motion with 10-degree of freedom comprising several inertial MEMS sensors: a 3D gyroscope; a 3D accelerometer; a 3D magnetometer (compass); and an atmospheric pressure sensor”; Paragraph 0090 and Fig. 4, wherein the insole motion processing and feedback subsystem 103 includes the motion processing element 1031 and a microprocessor 1034).
Regarding claim 6, Czaja further teaches wherein the at least one sensory stimulation unit comprises a first stimulation unit disposed on a first lower limb or prosthesis of the patient and a second stimulation unit disposed on a second lower limb or prosthesis of the patient (Figs. 2-5, wherein each insole comprises haptic actuator 1033).
Regarding claim 8, Czaja further teaches a user interface operably coupled to the processor, wherein the user interface is configured to display the patient-specific virtual biomechanical model (Paragraph 0084, “Based on GPS coordinates extracted from data, the cloud server retrieves 3D map of the area, then superimposes the graphical and numerical parameters of the run on said 3D map. This map, together with the graphical and numerical parameters of the run may be displayed on the remote computer or viewed on the user smart-phone”; Paragraph 0084, “Here an insole 100, of a ski boot 110, with an insole 100, communicates with a monitoring application 300, hosted in a smart-phone 200”, wherein the insole comprises microprocessor 1033 shown in Figs. 2-5).
Regarding claim 9, Czaja further teaches wherein the user interface comprises an application in a mobile device (Paragraph 0084, “Here an insole 100, of a ski boot 110, with an insole 100, communicates with a monitoring application 300, hosted in a smart-phone 200”).
Regarding claim 10, Czaja further teaches wherein the mobile device comprises a laptop or a smartphone (Paragraph 0084, “Here an insole 100, of a ski boot 110, with an insole 100, communicates with a monitoring application 300, hosted in a smart-phone 200”).
Regarding claim 11, Czaja teaches a system for improving sensorimotor function of a patient, the system comprising:
(a) at least one force and/or pressure sensor associated with at least one lower limb or prosthesis of a patient, wherein the at least one force and/or pressure sensor is configured to detect force and/or pressure information relating to the lower limb or prosthesis and transmit force and/or pressure signals based on the force and/or pressure information (Figs. 2-5; Paragraph 0076, “ In addition, to motion processing, two or more force pressure sensors are also embedded in the sole, said pressure sensors record the force applied to the pressure point on the insole”);
(b) at least one motion and/or angle sensor associated with at least one lower limb or prosthesis of a patient, wherein the at least one motion and/or angle sensor is configured to detect motion and/or angle information relating to the lower limb or prosthesis and transmit motion and/or angle signals based on the motion and/or angle information (Figs. 2-5; Paragraph 0085, “The motion processing element 1031, is configured for analysis of motion with 10-degree of freedom comprising several inertial MEMS sensors: a 3D gyroscope; a 3D accelerometer; a 3D magnetometer”);
(c) a processor (Fig. 4, microprocessor 1034) configured to receive the force and/or pressure signals and the motion and/or angle signals, generate a patient-specific virtual biomechanical model based on the force and/or pressure signals and the motion and/or angle signals (Paragraph 0076, wherein the motion data from the MEMS motion processor and the data from the pressure sensors can be combined to determine the phase the skis are in) to generate an estimated center of pressure and a center of gravity (Paragraph 0082, wherein COP is obtained from pressure sensor data; Paragraph 0119, “Based on signal from sensors, using inertia navigation algorithms, application calculates kinematics of the ski trajectory. Then using user parameters, creates biomechanical model of foot/ski interface, and the sensor kinematics is translated to segments kinematics by measuring the position (and timing) of COF”; Paragraphs 0123 and 0134, wherein center of mass is also calculated), and generate balance stimulation signals based on the estimated center of pressure and the center of gravity (Paragraph 0119, wherein the application provides haptic feedback based on the data and COF; Paragraph 0120);
(d) at least one sensory stimulation unit disposed on at least one lower limb or prosthesis of the patient, wherein the at least one sensory stimulation unit comprises at least two stimulators that are actuable to provide stimulation to the patient based on the balance stimulation signals (Figs 2-5, haptic actuator 1033; Paragraph 0002, “Furthermore, one or more actuators are embedded in the shoe insole to provide haptic feedback to the user foot”); and
(e) a user interface operably coupled to the processor, wherein the user interface is configured to receive information from the processor about the patient-specific virtual biomechanical model and display the patient-specific virtual biomechanical model based on the information from the processor (Paragraph 0084, “Based on GPS coordinates extracted from data, the cloud server retrieves 3D map of the area, then superimposes the graphical and numerical parameters of the run on said 3D map. This map, together with the graphical and numerical parameters of the run may be displayed on the remote computer or viewed on the user smart-phone”; Paragraph 0084, “Here an insole 100, of a ski boot 110, with an insole 100, communicates with a monitoring application 300, hosted in a smart-phone 200”, wherein the insole comprises microprocessor 1033 shown in Figs. 2-5).
Regarding claim 12, Czaja further teaches wherein a first of the at least one force and/or pressure sensor is associated with a first pad, wherein the first pad is disposable under a first foot or prosthetic foot of the patient (Figs. 2-5, insole 100 of ski boot 110 with pressure/force sensors 1032; Paragraph 0076, “In addition, to motion processing, two or more force pressure sensors are also embedded in the sole, said pressure sensors record the force applied to the pressure point on the insole”; Paragraph 0050, ski boots) and a second of the at least one force and/or pressure sensor is associated with a second pad, wherein the second pad is disposable under a second foot or prosthetic foot of the patient (Figs. 2-5, insole 100 of ski boot 110 with pressure/force sensors 1032; Paragraph 0076, “In addition, to motion processing, two or more force pressure sensors are also embedded in the sole, said pressure sensors record the force applied to the pressure point on the insole”; Paragraph 0050, ski boots).
Regarding claim 16, Czaja further teaches wherein the user interface comprises an application in a mobile device, wherein the mobile device comprises a laptop or a smartphone (Paragraph 0084, “Here an insole 100, of a ski boot 110, with an insole 100, communicates with a monitoring application 300, hosted in a smart-phone 200”).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Czaja as applied to claim 1 above, and further in view of Czaja.
Regarding claim 7, while Czaja discloses a haptic actuator in each insole (Figs. 2-5, haptic actuator 1033, totaling to two actuators), Czaja fails to explicitly disclose four total haptic actuators.
However, Czaja discloses wherein each insole may have one or more actuators each (Paragraph 0002, “one or more actuators are embedded in the shoe insole to provide haptic feedback to the user foot”). The actuators provide haptic feedback to the user, indicating timing and direction of force distribution required to execute turn or to correct running or walking pattern (Paragraph 0002). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the insole of Czaja to incorporate two actuators in each insole taught by Czaja to provide haptic feedback to a user for executing or correcting movement.
Claims 13-14 are rejected under 35 U.S.C. 103 as being unpatentable over Czaja as applied to claim 11 above, and further in view of Marcus (US 20220051779).
Regarding claims 13-14, Czaja further discloses wherein the at least one motion and/or angle sensor comprises five motion and/or angle sensors (Paragraph 0076, wherein one insole comprises a 3-axis accelerometer, 3 axis gyroscope, and 3 axis magnetometer; Paragraph 0085 and Figs. 2-5, motion processing element 1031; Paragraph 0050, wherein the accelerometer/gyroscope/magnetometer are applied to both boots; thus, there are 6 total sensors), wherein first and second motion and/or angle sensors are disposed on a first lower limb or prosthesis of the patient, third and fourth motion and/or angle sensors are disposed on a second lower limb or prosthesis of the patient Paragraph 0050, wherein the accelerometer/gyroscope/magnetometer are applied to both boots; thus, there are 6 total sensors, 3 associated with each lower limb), and
Regarding the limitations of claims 13 and 14, Czaja further discloses wherein each of the five motion and/or angle sensors is an inertial motion unit disposed within a sensor processing module (Paragraph 0085, “The motion processing element 1031, is configured for analysis of motion with 10-degree of freedom comprising several inertial MEMS sensors: a 3D gyroscope; a 3D accelerometer; a 3D magnetometer (compass); and an atmospheric pressure sensor”; Paragraph 0090 and Fig. 4, wherein the insole motion processing and feedback subsystem 103 includes the motion processing element 1031 and a microprocessor 1034). While Czaja discloses 6 total motion sensors, Czaja fails to explicitly disclose wherein one of the motion and/or angle sensors is associated with a lower back of the patient being operably coupled to a local central processor, wherein the local central processor is in communication with the processor.
However, Marcus teaches a device concerned with correcting user motion based on pressure and motion signals measured by worn IMUs, wherein a lower back sensor device (Fig. 12, IMU 1220 worn on the back of the torso; Fig. 2A, wherein the sensor devices include a local processor connected to a mobile computing device processor) is implemented to estimate orientation of the torso and identify/predict gait pathologies or changes in the terrain (Paragraph 0045). The device of Czaja is concerned with correcting user movement based on measured motion and pressure signals. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Czaja to incorporate a torso-worn IMU taught by Marcus to aid in identifying and predicting movement and terrain changes to correct the user’s movement.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Czaja as applied to claim 11 above, and further in view of Gesotti (US 6788976 – cited by Applicant).
Regarding claim 15, Czaja further discloses wherein the at least one sensory stimulation unit comprises a first stimulation unit disposed on a first lower limb or prosthesis of the patient and a second stimulation unit disposed on a second lower limb or prosthesis of the patient (Figs. 2-5, wherein each insole comprises haptic actuator 1033),
While Czaja discloses two stimulators (Figs. 2-5, haptic actuator 1033, totaling to two actuators), Czaja fails to explicitly disclose four total haptic actuators. Czaja also fails to explicitly disclose a band coupled to the lower limb or prosthesis, the four stimulators attached to the band, and a motion and/or angle sensor associated with one of the four stimulators.
However, Czaja discloses wherein each insole may have one or more actuators each (Paragraph 0002, “one or more actuators are embedded in the shoe insole to provide haptic feedback to the user foot”). The actuators provide haptic feedback to the user, indicating timing and direction of force distribution required to execute turn or to correct running or walking pattern (Paragraph 0002). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the insole of Czaja to incorporate four actuators taught by Czaja to provide haptic feedback to a user for executing or correcting movement.
Gesotti teaches an ankle band with stimulators that are attachable to the band using straps (Col 9, lines 31-45 and Figs. 5 and 7, ankle-band 504 with stimulation electrodes 510 and sensor device 508 comprising an accelerometer to provide information to the stimulator). This alternative arrangement of motion/angle sensors and stimulation electrodes taught by Gesotti are known. The substitution of the insole with the MEMS sensors and haptic actuators of Czaja with the arrangement taught by Gesotti would yield the predictable results of measuring motion/angle data and stimulating a user based on the motion/angle data. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the insole of Czaja with the ankle band of Gesotti and the results would have been predictable to one of ordinary skill in the art.
Claims 17-18 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Czaja and Marcus.
Regarding claims 17-18, Czaja discloses a system for improving sensorimotor function of a patient, the system comprising:
(a) a first footpad unit comprising a first footpad comprising at least one first force and/or pressure sensor positionable under a first foot or prosthetic foot of a first lower limb or prosthesis of a patient (Figs. 2-5, insole 100 of ski boot 110 with pressure/force sensors 1032; Paragraph 0076, “In addition, to motion processing, two or more force pressure sensors are also embedded in the sole, said pressure sensors record the force applied to the pressure point on the insole”), and a second footpad unit comprising a second footpad comprising at least one second force and/or pressure sensor positionable under a second foot or prosthetic foot of a second lower limb or prosthesis of the patient (Figs. 2-5, insole 100 of ski boot 110 with pressure/force sensors 1032; Paragraph 0076, “In addition, to motion processing, two or more force pressure sensors are also embedded in the sole, said pressure sensors record the force applied to the pressure point on the insole”; Paragraph 0050, ski boots), wherein each of the at least one first and second force and/or pressure sensors are configured to detect force and/or pressure information relating to the first and second lower limbs or prostheses, respectively, and transmit force and/or pressure signals based on the force and/or pressure information (Paragraph 0076, “In addition, to motion processing, two or more force pressure sensors are also embedded in the sole);
(b) first and second sensor processing modules comprising at least one first motion and/or angle sensor associated with the first lower limb or prosthesis of the patient, third and fourth sensor processing modules comprising at least one second motion and/or angle sensor associated with the second lower limb or prosthesis of the patient, wherein each of the at least one first, second, and third motion and/or angle sensors is configured to detect motion and/or angle information and transmit motion and/or angle signals based on the motion and/or angle information (Figs. 2-5; Paragraph 0085, “The motion processing element 1031, is configured for analysis of motion with 10-degree of freedom comprising several inertial MEMS sensors: a 3D gyroscope; a 3D accelerometer; a 3D magnetometer”; Paragraph 0050, wherein each insole comprises the several inertial MEMS sensors);
(c) a processor (Fig. 4, microprocessor 1034) configured to receive the force and/or pressure signals and the motion and/or angle signals, generate a patient-specific virtual biomechanical model based on the force and/or pressure signals and the motion and/or angle signals (Paragraph 0076, wherein the motion data from the MEMS motion processor and the data from the pressure sensors can be combined to determine the phase the skis are in) to generate an estimated center of pressure and a center of gravity (Paragraph 0082, wherein COP is obtained from pressure sensor data; Paragraph 0119, “Based on signal from sensors, using inertia navigation algorithms, application calculates kinematics of the ski trajectory. Then using user parameters, creates biomechanical model of foot/ski interface, and the sensor kinematics is translated to segments kinematics by measuring the position (and timing) of COF”; Paragraphs 0123 and 0134, wherein center of mass is also calculated), and generate balance stimulation signals based on the estimated center of pressure and the center of gravity (Paragraph 0119, wherein the application provides haptic feedback based on the data and COF; Paragraph 0120);
(d) at least one sensory stimulation unit disposed on at least one lower limb or prosthesis of the patient, wherein the at least one sensory stimulation unit comprises at least two stimulators that are actuable to provide stimulation to the patient based on the balance stimulation signals (Figs 2-5, haptic actuator 1033; Paragraph 0002, “Furthermore, one or more actuators are embedded in the shoe insole to provide haptic feedback to the user foot”); and
(e) a user interface operably coupled to the processor, wherein the user interface is configured to receive information from the processor about the patient-specific virtual biomechanical model and display the patient-specific virtual biomechanical model based on the information from the processor (Paragraph 0084, “Based on GPS coordinates extracted from data, the cloud server retrieves 3D map of the area, then superimposes the graphical and numerical parameters of the run on said 3D map. This map, together with the graphical and numerical parameters of the run may be displayed on the remote computer or viewed on the user smart-phone”; Paragraph 0084, “Here an insole 100, of a ski boot 110, with an insole 100, communicates with a monitoring application 300, hosted in a smart-phone 200”, wherein the insole comprises microprocessor 1033 shown in Figs. 2-5).
Regarding the limitations of claims 17 and 18, while Czaja discloses 6 total motion sensors, Czaja fails to explicitly disclose wherein one of the motion and/or angle sensors is associated with a lower back of the patient being operably coupled to a local central processor, wherein the local central processor is in communication with the processor.
However, Marcus teaches a device concerned with correcting user motion based on pressure and motion signals measured by worn IMUs, wherein a lower back sensor device (Fig. 12, IMU 1220 worn on the back of the torso; Fig. 2A, wherein the sensor devices include a local processor connected to a mobile computing device processor) is implemented to estimate orientation of the torso and identify/predict gait pathologies or changes in the terrain (Paragraph 0045). The device of Czaja is concerned with correcting user movement based on measured motion and pressure signals. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Czaja to incorporate a torso-worn IMU taught by Marcus to aid in identifying and predicting movement and terrain changes to correct the user’s movement.
Regarding claim 20, the combination of Czaja and Marcus further discloses wherein the user interface comprises an application in a mobile device, wherein the mobile devices comprises a laptop or a smartphone (Paragraph 0084, “Based on GPS coordinates extracted from data, the cloud server retrieves 3D map of the area, then superimposes the graphical and numerical parameters of the run on said 3D map. This map, together with the graphical and numerical parameters of the run may be displayed on the remote computer or viewed on the user smart-phone”; Paragraph 0084, “Here an insole 100, of a ski boot 110, with an insole 100, communicates with a monitoring application 300, hosted in a smart-phone 200”, wherein the insole comprises microprocessor 1033 shown in Figs. 2-5).
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Czaja and Marcus as applied to claim 17 above, and further in view of Czaja and Gesotti.
Regarding claim 19, Czaja further discloses wherein the at least one sensory stimulation unit comprises a first stimulation unit disposed on a first lower limb or prosthesis of the patient and a second stimulation unit disposed on a second lower limb or prosthesis of the patient (Figs. 2-5, wherein each insole comprises haptic actuator 1033),
While Czaja discloses two stimulators (Figs. 2-5, haptic actuator 1033, totaling to two actuators), Czaja fails to explicitly disclose four total haptic actuators. Czaja also fails to explicitly disclose a band coupled to the lower limb or prosthesis, the four stimulators attached to the band, and a motion and/or angle sensor associated with one of the four stimulators.
However, Czaja discloses wherein each insole may have one or more actuators each (Paragraph 0002, “one or more actuators are embedded in the shoe insole to provide haptic feedback to the user foot”). The actuators provide haptic feedback to the user, indicating timing and direction of force distribution required to execute turn or to correct running or walking pattern (Paragraph 0002). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the insole of Czaja to incorporate four actuators taught by Czaja to provide haptic feedback to a user for executing or correcting movement.
Gesotti teaches an ankle band with stimulators that are attachable to the band using straps (Col 9, lines 31-45 and Figs. 5 and 7, ankle-band 504 with stimulation electrodes 510 and sensor device 508 comprising an accelerometer to provide information to the stimulator). This alternative arrangement of motion/angle sensors and stimulation electrodes taught by Gesotti are known. The substitution of the insole with the MEMS sensors and haptic actuators of Czaja with the arrangement taught by Gesotti would yield the predictable results of measuring motion/angle data and stimulating a user based on the motion/angle data. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the insole of Czaja with the ankle band of Gesotti and the results would have been predictable to one of ordinary skill in the art.
Conclusion
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/NOAH M HEALY/Examiner, Art Unit 3791
/JASON M SIMS/Supervisory Patent Examiner, Art Unit 3791
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