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 .
Specification
The use of the term Bluetooth and BLE (Bluetooth Low Energy), which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Claim Objections
Claims 8 and 11-12 are objected to because of the following informalities:
Claim 8 “a measuring device according to claim 1” should be “the measuring device according to claim 1” as the measuring device has already been introduced in claim 1.
Claim 11, line 3 “the position” should be “a position”.
Claim 11, line 3 “the barycenter” should be “a barycenter”.
Claim 12, line 3 “the contour” should be “a contour”.
Claim 12, line 4 “the outline” should be “an outline”.
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 1-12 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.
Claim 1 recites the limitation “the foot” in line 1-2 of the claim. There is insufficient antecedent basis for this limitation of the claim as a user generally has two feet and the current claim language does not clarify which foot is being monitored. It is suggested that the limitation be amended to “a foot”.
Claim 1 recites the limitation “the forces” in line 6. There is insufficient antecedent basis for this limitation of the claim. It is suggested that the limitation be amended to “forces”.
Claim 1 recites “a finite set of separate contact zones” followed by references within claim 1 and the dependent claim to “the contact zones” and “the corresponding contact zones”. It is recommended that the limitations be amended for consistency to refer to “contact zones” or “each of the contact zones” as necessary to clarify when the entire finite set of separate contact zones is being referred to elsewhere in the claim and when only a single contact zone of the set is being discussed.
Claim 1 recites “sensors interposed between the support and the inner sole respectively at the contact zones, and each configured to provide a signal representative of a force exerted on the corresponding contact zone; and a processing unit connected to the sensors and configured to acquire the force signals provided by the sensors”. Claim 1 and its dependents thus appear to refer interchangeably to “signal representative of a force” measured by each of the sensors, “the signals”, and “the force signals”. It is recommended that a single term be adopted throughout the claims for consistency, and each of these terms from claim 1 and its dependents is interpreted as referring to the same element.
Claim 6 recites the limitation “the sole”. There is insufficient antecedent basis for this limitation of the claim. The limitation is interpreted as referring to the inner sole.
Claims 2-12 are additionally rejected under 35 U.S.C. 112(b) as indefinite due to their dependence on claim 1, which has been rejected as indefinite.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-4 and 6-10 is/are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Gray (US 6122846 A).
Regarding claim 1, Gray teaches a device for measuring a bearing force exerted by the foot of a patient (shoe 10), the device comprising:
a support (lower sole portion 26, figure 1);
an inner sole (foot plate 16, figure 2) that is intended to support the patient's foot and that is held on the support, the support and the sole being arranged so that, when the patient's foot is bearing on the inner sole, the forces exerted by the patient's foot on the inner sole are transmitted to the support in a finite number of separate contact zones (figure 10 shows forces on the foot plate 16 being transmitted to contact zones 39, 38, 52 between the foot plate and the support 26; column 5, lines 25-36, column 7, lines 14-35—foot plate 16 is positioned above the upper surface 28 of the sole. Foot plate 16 rests on foot plate front support 36 and foot plate rear support 38…forces transmitted directly downward onto the horizontal length of the beam 52 through front support 36 and rear support 38…the weight Fw applied vertically downward by the wearer is converted to forces applied within the beam 52…);
sensors (strain gauge 90) that are interposed between the support and the inner sole respectively at the contact zones and that are each configured to deliver a signal representative of a force exerted on the corresponding contact zone (column 7, lines 14-64— the weight Fw applied vertically downward by the wearer is converted to forces applied within the beam 52 by force component F.sub.1 of weight F.sub.w exerted by the user's heel bearing upon foot plate 16, foot plate rear support 38, and cross-pin 82, and onto beam 52, thus creating a clockwise moment defined by F.sub.1 multiplied by distance X.sub.3 about cross-pin 84, which is the center of rotation for rear half frame 74. Likewise, the user's forefoot creates force component F.sub.2 of weight F.sub.w upon foot plate 16, foot plate front support 36, and cross-pin 64, and onto beam 52, thus creating counter-clockwise moment defined by F.sub.2 multiplied by distance X.sub.4 about cross-pin 62, which is the sliding center of rotation for front half frame 54…strain which can be measured by the strain gauge 90…); and
a processing unit (Analyzing means 100) connected to the sensors and configured to acquire the force signals delivered by the sensors (column 7, line 52 – column 8, line 7-- electronic means of the analyzing means 100 includes microprocessor having circuitry to analyze the strain gage signals 96 generated by at least one strain gage 90. One embodiment utilizes a microchip and microcontroller that provides sufficient computing power to accomplish the calculations required for analyzing the strain recorded by strain gages 90, and for calculating forces imposed on the foot plate 16 by the wearer, along with additional software for completion of the multiple tasks such as analog to digital conversion of electrical signals).
Regarding claim 2, Gray teaches the device according to claim 1. Gray additionally teaches a retaining member (Fig. 2—screws may pass through holes 22 and 24 to secure the foot plate 16 to the lower sole portion 26) arranged between the inner sole and the support in a retaining zone distinct from the contact zones, for securing the inner sole to the support without transmitting the forces exerted on the sole to the support (column 4, lines 34-64 and column 5, lines 14-24-- The foot plate front support 36 is attachable by screws to the underside 20 of foot plate 16 by attachment to front attachment holes 22. The foot plate 16 is attachable at the heel area 32 with screws (not shown) to the rear foot plate support 38, that is located at the rear portion of the beam 52, in front of the rear beam support 46 connector).
Regarding claim 3, Gray teaches the device according to claim 2. Gray additionally teaches wherein the retaining member is configured to be partially engaged in an orifice (Fig. 2—screws may pass through holes 22 and 24 to secure the foot plate 16 to the lower sole portion 26) through the support and to be fixed in the inner sole, such that the retaining member is retained by the support upwards with a non-zero clearance (column 4, lines 34-64 and column 5, lines 14-24-- The foot plate front support 36 is attachable by screws to the underside 20 of foot plate 16 by attachment to front attachment holes 22. The foot plate 16 is attachable at the heel area 32 with screws (not shown) to the rear foot plate support 38, that is located at the rear portion of the beam 52, in front of the rear beam support 46 connector).
Regarding claim 4, Gray teaches the device according to claim 1. Gray additionally teaches wherein the support comprises an outer sole of a domed shape along a longitudinal axis of the support (Figs. 1-2, lower surface 30 of the lower sole portion 26).
Regarding claim 6, Gray teaches the device according to claim 1. Gray additionally teaches wherein the support has the shape of a shell with a rim surrounding the sole (Fig. 2).
Regarding claim 7, Gray teaches the device according to claim 1. Gray additionally teaches the processing unit is configured to calculate in real time a force value applied by the foot of the patient on the inner sole from the signals provided by the sensors (column 7, line 52 – column 8, line 7-- electronic means of the analyzing means 100 includes microprocessor having circuitry to analyze the strain gage signals 96 generated by at least one strain gage 90. One embodiment utilizes a microchip and microcontroller that provides sufficient computing power to accomplish the calculations required for analyzing the strain recorded by strain gages 90, and for calculating forces imposed on the foot plate 16 by the wearer, along with additional software for completion of the multiple tasks such as analog to digital conversion of electrical signals), and transmit the force value to an external equipment (Col. 8, line 31-51--transmittal of output signals 102 by transmitter 104 to the receiver unit circuitry 106…), and/or
the processing unit is configured to transmit in real time measurements representative of the signals provided by the sensors to the external equipment, the external equipment being configured to calculate in real time a force value applied by the foot of the patient on the inner sole from the measurements provided by the processing unit (Col. 8, line 31-Col. 9, line 8--Analyses as to whether the output signals 102 have exceeded pre-selected upper threshold limits, or are below pre-selected lower threshold limits for minimum required weight placed on the foot, are accomplished in the receiver and display unit 118, which can be a device in the shape of a pager 118 (FIG. 1). The transmitted output signals 102 from the transmitter 104 of the force sensing unit 50, are received by a receiver unit circuitry having signal processing means 106 within the receiver and display unit 118; Col. 9, line 15-25-- The information gathered by the receiver and display unit 118 can be transmitted to a remote computer database and associated software for storage and calculations of the wearer's history of weight transfer onto the limb undergoing rehabilitation, for displaying real-time on a computer monitor, and for training of the wearer to improve the wearer's weight transfer on the limb undergoing rehabilitation).
Regarding claim 8, Gray teaches the device according to claim 1. Gray additionally teaches a system for rehabilitating a lower limb of a patient (Col. 2, line 41-45, Col. 3, line 63-Col. 4, line 6-- An improved force monitoring system… during rehabilitation of an injured lower extremity), the system comprising:
a measuring device according to claim 1 (Col. 3, line 63-Col. 4, line 6-- incorporating a force monitoring apparatus within an orthopedic shoe including various features of the present invention is illustrated generally as a force monitoring shoe 10), and human-machine interface (Receiver and display unit 118) in communication with the processing unit of the measuring device (Col. 8, line 45-48-- transmitted output signals 102 from the transmitter 104 of the force sensing unit 50, are received by a receiver unit circuitry having signal processing means 106 within the receiver and display unit 118) and configured to emit in real time a signal representative of a force value calculated from the force signals provided by the sensors (Col. 8, line 52-Col. 9, line 25-- The receiver and display unit 118 can provide audible warnings in the form of alarms or variable volume controlled audio tones, and/or visual displays in the form of colored LED display 120 and a numerical display 124, and/or vibrator action of the pager shaped device to allow for notification of the wearer that preset weight limits have been exceeded for upper threshold limits…The receiver and display unit 118 can be programmed to display numerically the weights measured by the force sensing unit 50…).
Regarding claim 9, Gray teaches the device according to claim 8. Gray additionally teaches wherein the human-machine interface comprises a mobile terminal in communication with the processing unit (Col. 8, line 40-52-- The transmitted output signals 102 from the transmitter 104 of the force sensing unit 50, are received by a receiver unit circuitry) and provided with a dedicated application configured to process signals transmitted by the processing unit (Col. 8, line 40-52--signal processing means 106 within the receiver and display unit 118, for comparisons of weight measurements with pre-selected upper threshold and lower threshold weight limits by appropriate software and computations of the processing means).
Regarding claim 10, Gray teaches the device according to claim 8. Gray additionally teaches wherein the human-machine interface is configured to emit in real time: a first light and/or sound signal when the force value is comprised in a first range of force values, and a second light and/or sound signal when the force value is comprised in a second range of force values, greater than the first range of force values, and less than a set value (Col. 8, line 52-Col. 9, line 25-- The receiver and display unit 118 can provide audible warnings in the form of alarms or variable volume controlled audio tones, and/or visual displays in the form of colored LED display 120 and a numerical display 124, and/or vibrator action of the pager shaped device to allow for notification of the wearer that preset weight limits have been exceeded for upper threshold limits. The colored LED display 120 can indicate by show of colored lights whether the lower threshold limits are met by the wearer of the force monitoring shoe 10…). It is noted that by providing an alarm or other notification to the user that a preset weight limit has been exceeded, the system may be seen to provide a first notification when the force value is in a first range (not yet exceeded an upper limit) and a second notification when the force value is in a second range greater than the first range (exceeded threshold). As the system is described as including additional upper and lower threshold limits, it may additionally be seen to teach a first light and/or sound signal when the force value is comprised in a first range of force values, and a second light and/or sound signal when the force value is comprised in a second range of force values, greater than the first range of force values, and less than a set value.
Claim(s) 1 and 4-12 is/are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Czaja (US 20210046356 A1).
Regarding claim 1, Czaja teaches a device for measuring a support force exerted by the foot of a patient (Shoe 111; Figs. 2-3), the device comprising:
a support (Lower insole surface 101);
an inner sole intended to support the patient's foot, held on the support (Upper insole surface 102), the support and the inner sole being arranged so that, when the foot of the patient is bearing on the inner sole, the forces exerted by the foot of the patient on the inner sole are transmitted to the support in a finite set of separate contact zones (Fig. 3; paragraph 0179);
sensors interposed between the support and the inner sole respectively at the contact zones, and each configured to provide a signal representative of a force exerted on the corresponding contact zone (Sensors 1032; paragraph 0179-- a motion and force processing sub-system and a feedback sub-system 103 is sandwiched between the insole surfaces 101, 102…at least three force sensors 1032, positioned under the user's foot 1.sup.st Metatarsal, 5.sup.th Metatarsal and the heel (foo POB)…); and
a processing unit connected to the sensors and configured to acquire the force signals provided by the sensors (microprocessor 1034; paragraph 0179).
Regarding claim 4, Czaja teaches the device according to claim 1. Czaja additionally teaches wherein the support comprises an outer sole of a domed shape along a longitudinal axis of the support (Fig. 5—the outer sole curves in a dome shape).
Regarding claim 5, Czaja teaches the device according to claim 1. Czaja additionally teaches wherein the sensors comprise three force sensors including a sensor arranged under a rear portion of the inner sole, and two sensors arranged under a front portion of the inner sole (Fig. 3, sensors 1032; paragraph 0179-- at least three force sensors 1032, positioned under the user's foot 1.sup.st Metatarsal, 5.sup.th Metatarsal and the heel (foo POB)).
Regarding claim 6, Czaja teaches the device according to claim 1. Czaja additionally teaches wherein the support has the shape of a shell with a rim surrounding the sole (Fig. 5—the outer sole has a shell shape that surrounds the upper insole surface).
Regarding claim 7, Czaja teaches the device according to claim 1. Czaja additionally teaches the processing unit is configured to calculate in real time a force value applied by the foot of the patient on the inner sole from the signals provided by the sensors, and transmit the force value to an external equipment (Paragraph 0179-0180--microprocessor assembles motion information (for example, g-force, acceleration, Euler Angles and Quaternion information) and force vectors from all of the force sensors into a data packet. After appropriate encapsulation with packet control information the microprocessor communicates the packet to the Bluetooth interface for transmission to the smartphone based analysis application…), and/or
the processing unit is configured to transmit in real time measurements representative of the signals provided by the sensors to the external equipment, the external equipment being configured to calculate in real time a force value applied by the foot of the patient on the inner sole from the measurements provided by the processing unit (Paragraph 0116, 0157-0158, 0174--transmits the pressure and motion data obtained from the ski-boot insole together with the GPS timing and coordinates to the remote location for post-processing using wireless cellular network. During post-processing, a 3D map based on GPS coordinates is retrieved and superimposed on the motion/pressure data, which may be provided in real-time on a remote computer or a smartphone…)
Regarding claim 8, Czaja teaches the device according to claim 1. Czaja additionally teaches a system for rehabilitating a lower limb of a patient (Fig. 1Bl paragraph 0010, 0015, 0172), the system comprising: a measuring device according to claim 1 (see above), and human-machine interface (Smartphone 200) in communication with the processing unit of the measuring device (Paragraph 0178) and configured to emit in real time a signal representative of a force value calculated from the force signals provided by the sensors (Paragraph 0125, 0161, 0178-0179, 0195-0196, 0202-- resultant graphical and numerical parameters displayed on a remote computer or on the user's smartphone).
Regarding claim 9, Czaja teaches the device according to claim 8. Czaja additionally teaches wherein the human-machine interface comprises a mobile terminal (Monitoring application 300 of the smartphone 200) in communication with the processing unit and provided with a dedicated application configured to process signals transmitted by the processing unit (Paragraph 0125, 0161, 0178-0179, 0195-0196, 0202-- The monitoring application 300 pre-processes motion and pressure data, retrieves a GPS time and coordinates from the smartphone, and transmits this data using a smartphone cellular radio interface 221 in some embodiments, to the cloud service 500, for further post-processing…).
Regarding claim 10, Czaja teaches the device according to claim 8. Czaja additionally teaches wherein the human-machine interface is configured to emit in real time: a first light and/or sound signal when the force value is comprised in a first range of force values, and a second light and/or sound signal when the force value is comprised in a second range of force values, greater than the first range of force values, and less than a set value (Paragraph 0010, 0125, 0161, 0176-0179, 0184-0185, 0195-0196, 0202--analyzing of complex GRF in 3D space provides potential to avoid many foot injuries by alerting the user when such forces exceeds predefined safety threshold or when a repetitive force may lead to a stress in the specific foot area…).
Regarding claim 11, Czaja teaches the device according to claim 8. Czaja additionally teaches wherein the processing unit or the human-machine interface is configured to calculate in real time the position of a pressure center located at the barycenter of the forces exerted on the contact zones and measured by the sensors (Paragraph 0010, 0083-0087, 0174, -0177, 0183, 0187, 0190-0196-- recordings of motion and force vectors, synchronized with GPS time and coordinates, are transmitted to a smartphone based application for analysis, storage and to compute a corrective response which is send back to the haptic actuator(s) embedded in the insoles. Such corrective feedback response is based on the past and current motion and force vectors, and difference between biomechanical model of activity and kinematics of current user motion and intended to provide information on time and the location the center of pressure (COP) must be located during a next turn or phase of the gait… Past and current locations of the COP and the user foot motion in 3-dimantional space obtained by calculating Quaternion of the motion vectors allows for prediction of foot movement during the next gait phase or even next gait cycle…).
Regarding claim 12, Czaja teaches the device according to claim 11. Czaja additionally teaches wherein the human machine interface is configured to display the position of the center of pressure in relation to the contour of a human foot, and/or variations over time of the position of the center of pressure in the form of chronograms and/or in relation to the outline of a human foot (Paragraph 0010, 0083-0087, 0174, -0178, 0183, 0187, 0190-0196-- Past and current locations of the COP and the user foot motion in 3-dimantional space obtained by calculating Quaternion of the motion vectors allows for prediction of foot movement during the next gait phase or even next gait cycle…; Fig. 6B, 7A-B, 14-15, 21A-B, 23A-B, 24A-B).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 5, 11-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gray in view of Czaja.
Regarding claim 5, Gray teaches the device according to claim 1. Gray additionally teaches the sensors may comprise multiple sensors (Column 7, lines 1-13). However, Gray does not explicitly disclose wherein the sensors comprise wherein the sensors comprise three force sensors including a sensor arranged under a rear portion of the inner sole, and two sensors arranged under a front portion of the inner sole.
Czaja, in the same field of endeavor of a force sensing insole apparatus, teaches wherein the sensors comprise three force sensors including a sensor arranged under a rear portion of the inner sole, and two sensors arranged under a front portion of the inner sole (Fig. 3, sensors 1032; paragraph 0179-- at least three force sensors 1032, positioned under the user's foot 1.sup.st Metatarsal, 5.sup.th Metatarsal and the heel (foo POB)).
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the device of Gray, including one or more sensors for monitoring the forces of the user’s foot, to include three force sensors including a sensor arranged under a rear portion of the inner sole, and two sensors arranged under a front portion of the inner sole as described by Czaja in order to predictably improve the ability of the system to monitor the gait of the user by enabling the system to determine the center of pressure, center of force, and center of mass based on the position of multiple force sensors (see paragraphs 0083-0087, 0179 of Czaja).
Regarding claim 11, Gray teaches the device according to claim 8. However, Gray fails to teach wherein the processing unit or the human-machine interface is configured to calculate in real time the position of a pressure center located at the barycenter of the forces exerted on the contact zones and measured by the sensors.
Czaja, in the same field of endeavor of a force sensing insole apparatus, teaches wherein the processing unit or the human-machine interface is configured to calculate in real time the position of a pressure center located at the barycenter of the forces exerted on the contact zones and measured by the sensors (Paragraph 0010, 0083-0087, 0174, -0177, 0183, 0187, 0190-0196-- recordings of motion and force vectors, synchronized with GPS time and coordinates, are transmitted to a smartphone based application for analysis, storage and to compute a corrective response which is send back to the haptic actuator(s) embedded in the insoles. Such corrective feedback response is based on the past and current motion and force vectors, and difference between biomechanical model of activity and kinematics of current user motion and intended to provide information on time and the location the center of pressure (COP) must be located during a next turn or phase of the gait… Past and current locations of the COP and the user foot motion in 3-dimantional space obtained by calculating Quaternion of the motion vectors allows for prediction of foot movement during the next gait phase or even next gait cycle…).
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the system of Gray to perform the pressure center calculations of Czaja in order to predictably improve the usefulness of the device in rehabilitation as knowledge of the center of pressure may enable more accurate and thorough monitoring of the gait of the user.
Regarding claim 12, the combination of Gray and Czaja teaches the system according to claim 11. Gray generally teaches a display for providing signals to a user to assist in rehabilitation (Receiver and display unit 118; Col. 8, line 52-Col. 9, line 25). However, Gray fails to teach wherein the human machine interface is configured to display the position of the center of pressure in relation to the contour of a human foot, and/or variations over time of the position of the center of pressure in the form of chronograms and/or in relation to the outline of a human foot.
Czaja additionally teaches wherein the human machine interface is configured to display the position of the center of pressure in relation to the contour of a human foot, and/or variations over time of the position of the center of pressure in the form of chronograms and/or in relation to the outline of a human foot (Paragraph 0010, 0083-0087, 0174, -0178, 0183, 0187, 0190-0196-- Past and current locations of the COP and the user foot motion in 3-dimantional space obtained by calculating Quaternion of the motion vectors allows for prediction of foot movement during the next gait phase or even next gait cycle…; Fig. 6B, 7A-B, 14-15, 21A-B, 23A-B, 24A-B).
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the system of Gray to display the pressure center positions of Czaja in order to predictably improve the usefulness of the device in rehabilitation as knowledge of the center of pressure may enable more accurate and thorough monitoring of the gait of the user and display of the center of pressure may allow a user to adjust their gait to improve balance and positioning.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANNA ROBERTS whose telephone number is (571)272-7912. The examiner can normally be reached M-F 8:30-4:30 EST.
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/ANNA ROBERTS/Examiner, Art Unit 3791
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