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 .
Status of Claims
2. Claims 1-27 are pending and currently under consideration for patentability under 37 CFR 1.104.
Election/Restrictions
Applicant’s election without traverse of Invention I, in the reply filed on August 24, 2026, is acknowledged. As such, claims 15-26 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Information Disclosure Statement
The information disclosure statement filed August 13, 2024, fails to comply with 37 CFR 1.98(a)(2), which requires a legible copy of each cited foreign patent document; each non-patent literature publication or that portion which caused it to be listed; and all other information or that portion which caused it to be listed. No copy has been provided for JP 201900928. However, it is noted that this appears to contain a typographical error for JP 2019500928. Additionally, it is noted that the IDS lists WO 2018183386, but has provided the incorrect document WO 2018183366.
It has been placed in the application file, but the information referred to therein has not been considered.
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.
Claim Objections
Claims 2 and 7 are objected to because of the following informalities:
Claim 2, line 3 recites “a joint manipulation device system” and the Examiner suggests –the joint manipulation device system—to clarify the antecedent basis from claim 1, line 1.
Claim 2, line 4 recites “a joint manipulation device” and the Examiner suggests –the joint manipulation device—to clarify the antecedent basis from claim 1, lines 9-10.
Claim 7, line 3 recites “a joint manipulation device system” and the Examiner suggests –the joint manipulation device system—to clarify the antecedent basis from claim 1, line 1.
Claim 7, line 4 recites “a joint manipulation device” and the Examiner suggests –the joint manipulation device—to clarify the antecedent basis from claim 1, lines 9-10.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim(s) 1-14 and 27 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, line 4 recites “the memory device” which lacks antecedent basis. Claim 1 previously recites “one or more memory devices.” Thus, the Examiner suggests –the one or more memory devices—.
Claim 4, line 7 recites “a second audible alert” which is confusing because this is the first audible alert that has been recited. Thus, it is unclear whether claim 4 requires two audible alerts, or one.
Claim 11, lines 1-3 recite “the effectiveness data is transmitted to one or more doctors, physical therapists, or insurance provider organizations associated with the user or the joint manipulation device system” which is a method step. A single claim which claims both an apparatus and the method steps of using the apparatus is indefinite under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph. See In re Katz Interactive Call Processing Patent Litigation, 639 F.3d 1303, 97 USPQ2d 1737 (Fed. Cir. 2011). MPEP 2173.05(p)(II).
Claim 14, lines 2-3 recite “as measured from one or more pictures taken by the user using the application running on the mobile device” which is a method step. A single claim which claims both an apparatus and the method steps of using the apparatus is indefinite under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph. See In re Katz Interactive Call Processing Patent Litigation, 639 F.3d 1303, 97 USPQ2d 1737 (Fed. Cir. 2011). MPEP 2173.05(p)(II).
Claim Rejections - 35 USC § 102
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.
(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.
Claim 27 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Malone et al. (2018/0271436).
Regarding claim 27, Malone discloses a system for monitoring compliance (Fig. 1, Figs. 14-16. Able to monitor compliance through sensor(s) 2, see the penultimate sentence of [0041] and lines 5-10 of [0022]), the system comprising:
one or more memory devices (data acquisition modules 22, servers 58, cloud storage 60, client devices 62, 64, Figs. 14-16. Each of these elements would have an associated memory); and
one or more processing devices (data acquisition modules 22, patient and therapist client devices 62, 64, Figs. 14-16; “data acquisition device may include a processor configured to receive and process data” see para. [0044], and the client devices 62, 64, are computers such as smart phones or tablets, desktop computers, mobile devices, see para. [0044], [0050]) operatively coupled to the memory device (they are “operatively coupled” because data is able to be transmitted, processed, and stored among the one or more memory devices and the one or more processing devices depicted in Figs. 14-16. See para. [0049]), wherein the one or more processing devices are configured to execute computer-readable computer program code (the one or more processing devices include smart phones or tablets, desktop computers, mobile devices, etc., see Figs. 14-16, para. [0044], para. [0050]-[0051]) to:
receive compliance data from a joint manipulation device system associated with compliant operation of a joint manipulation device by a user (sensor(s) 2, Fig. 1, “may detect placement of the limb (e.g., via pressure), and may send signals to a data logger for tracking patient compliance” see the penultimate sentence of [0041], and “non-compliance may be identified and acted upon during the session in question,” see lines 5-10 of [0022]);
compare the received compliance data with predetermined compliant conditions (one of ordinary skill in the art would recognize that a certain number and/or amount of pressure read from the sensors 2 will be predetermined to indicate the proper placement of the limb, see the penultimate sentence of [0041]. Additionally, the system states: “Reminders and alerts may remind patients of upcoming sessions and may also include compliance related information during a session. Such information may tell the patient when to initiate the session, when to stop, and reminders to continue should the sensor network detect the patient has stopped before the prescribed terminal point” para. [0047]. Using the “sensor network” to detect the patient has stopped before a prescribed terminal point is a comparison of received compliance data from sensor(s) 2 with predetermined compliant conditions);
determine, based on the comparison of the received compliance data with the predetermined compliant conditions, whether the joint manipulation device is currently compliant with the predetermined compliant conditions (a determination is made as to whether the placement of the limb is indicative of compliance, see the penultimate sentence of [0041], see lines 5-10 of [0022], and a determination is made as to whether “the patient has stopped before a prescribed terminal point,” see para. [0047]); and
transmit one or more control signals configured to cause a speaker associated with the joint manipulation device (the patient client 62 or 64, such as their smart phone, Figs. 13-16; “The system may be able to send reminders, alerts, and other pertinent information to a patient during the therapy session … Such alerts and reminders may be in the form of phone notifications, emails, text messages, automated phone calls, or other electronic communication modalities” see para. [0047]. At least the automated phone calls would read on a speaker device associated with the joint manipulation system, as the user’s phone is receiving sensor data and providing feedback about the usage of the joint manipulation system) to emit either (i) an audible alert representing the compliant operation of the joint manipulation device, or (the claim only requires one of either (i) or (ii)) (ii) an audible alert representing the not compliant operation of the joint manipulation device (“reminders to continue should the sensor network detect the patient has stopped before the prescribed terminal point” see para. [0047]. Stopping before the prescribed terminal point is non-compliant use).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1-7, and 9-14 are rejected under 35 U.S.C. 103 as being unpatentable over Malone et al. (2018/0271436) in view of Noda et al. (2018/0153445).
Regarding claim 1, Malone discloses a system (Figs. 14-16; i.e., para. [0049]) for measuring and monitoring a joint manipulation device system (physical therapy device 4, Fig. 1, Figs. 14-16), the system comprising:
one or more memory devices (data acquisition modules 22, servers 58, cloud storage 60, client devices 62, 64, Figs. 14-16. Each of these elements would have an associated memory); and
one or more processing devices (data acquisition modules 22, patient and therapist client devices 62, 64, Figs. 14-16; “data acquisition device may include a processor configured to receive and process data” see para. [0044], and the client devices 62, 64, are computers such as smart phones or tablets, desktop computers, mobile devices, see para. [0044], [0050]) operatively coupled to the memory device (they are “operatively coupled” because data is able to be transmitted, processed, and stored among the one or more memory devices and the one or more processing devices depicted in Figs. 14-16. See para. [0049]), wherein the one or more processing devices are configured to execute computer-readable computer program code (the one or more processing devices include smart phones or tablets, desktop computers, mobile devices, etc., see Figs. 14-16, para. [0044], para. [0050]-[0051]) to:
receive progress data (one or more sensors 2, Fig. 1; “sensors 2 may maintain communication with other network devices through a data acquisition module 22 that attaches to the therapy device 4 being used. Such a module may act as a data acquisition device for data collection, conditioning, and transmission … may use wired or wireless protocols for communication with the sensors 2 and other devices in the network” see para. [0044] and Figs. 14-16) corresponding to the joint manipulation device system (the sensors 2 are part of the joint manipulation device system 4 and thus correspond), wherein the progress data comprises at least one of pressure data, force data, time data, and range of motion data associated with a joint of a user during operation of a joint manipulation device (“such feedback may include … start and stop times, … range of motion based on an array of sensors … pressure profile seen across the contact area…” see para. [0024]; “sensors 2 may be temperature sensors, pressure sensors, force sensors” see the first sentence of [0040]);
aggregate the received progress data into effectiveness data (“ability to aggregate compliance data for multiple users to gather information pertaining to demographic analysis of patient compliance” see para. [0052]. The aggregated patient compliance data is considered “effectiveness data” as it represents effective uses of the device, i.e., being compliant); and
in response to aggregating the received progress data, transmit the effectiveness data to one or more third party systems (see Figs. 14-16, the data acquisition module 22 is configured to transmit collected data to remote patient and therapist client devices 62, 64, via a server 58 and/or a cloud 60. See para. [0049]. These may be third party systems, such as being accessible by healthcare workers/doctors. See para. “The data may also be made available to the patient by means of a terminal or smart device, such as a phone or tablet, and thus allow compliance to be monitored by the patient, therapist, or both during a session in real time” see the first sentence of [0046]. “DAQ may send all data solely to the cloud 60 and all client devices 62 and 64 may access the data from the cloud 60” see the last sentence of [0049]).
Malone states that the sensors (2) “may detect placement of the limb (e.g., via pressure), and may send signals to a data logger for tracking patient compliance” (see the penultimate sentence of [0041]) and states that periods of “non-compliance may be identified and acted upon during the session in question” (see lines 5-10 of [0022]). However, Malone is silent regarding wherein progress data collected during a period of non-compliance is excluded from the effectiveness data.
Noda teaches a related rehabilitation system for measuring range of motion (see Figs. 1-3; creating an index value for evaluating rehabilitation, see para. [0009]) with a data collecting unit (data acquisition unit 11, Fig. 2; “acquires positional information on a plurality of predetermined portions of limbs of the test subject on the basis of the information obtained from the three-dimensional sensor 7” see the first sentence of [0054]), wherein progress data (i.e., range of motion data collected in Figs. 3-8) collected during a period of non-compliance (periods when the user’s posture is improper are considered period(s) of non-compliance) is excluded from the effectiveness data (“measurement device 10 excludes the angle calculated in (S82) from the subsequent selection candidates of a maximum value in a case where it is determined that the posture is improper. This is because an angle measured with an improper posture is not set to be an accurate ability index.” See the last two sentences of [0090], emphasis added. “Thereby, only an ability index measured in a proper posture is set to be a maximum value, and thus it is possible to accurately present the ability of a limb of the test subject” see the penultimate sentence of [0096]). Thus, when a patient is not compliant with the exercise protocol by having an improper posture, the measured range of motion data is excluded. This improves the accuracy of the range of motion measurements.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the Malone device such that when Malone’s sensors identify a period of non-compliance, the progress data collected during the period of non-compliance is excluded from the effectiveness data as generally taught by Noda because this improves the accuracy of the range of motion measurements by excluding data taken with an improper (i.e., non-compliant) posture.
Regarding claim 2, the modified Malone/Noda device discloses wherein the one or more processing devices (data acquisition modules 22, patient and therapist client devices 62, 64, Figs. 14-16 of Malone) are further configured to execute computer-readable computer program code to: receive compliance data corresponding to a joint manipulation device system associated with compliant operation of a joint manipulation device by a user (sensor(s) 2 of Malone “may detect placement of the limb (e.g., via pressure), and may send signals to a data logger for tracking patient compliance” (see the penultimate sentence of [0041], and “non-compliance may be identified and acted upon during the session in question,” see lines 5-10 of [0022] of Malone); compare the received compliance data with predetermined compliant conditions (one of ordinary skill in the art would recognize that a certain number and/or amount of pressure read from the sensors 2 will be predetermined to indicate the proper placement of the limb, see the penultimate sentence of [0041] of Malone); and provide an indication of a compliant status to the user at an indicator (such as the user’s mobile phone, see Figure 13 of Malone, “Session Compliance: 100% You are meeting your goals!”; and “Reminders and alerts may remind patients of upcoming sessions and may also include compliance related information during a session. Such information may tell the patient when to initiate the session, when to stop, and reminders to continue should the sensor network detect the patient has stopped before the prescribed terminal point” para. [0047] of Malone) based on the comparison of the received compliance data and the predetermined compliant conditions (the sensors are used to determine limb placement and prescribed terminal points, based on predetermined compliant conditions).
Regarding claim 3, the modified Malone/Noda device discloses wherein providing an indication of a compliant status to the user at an indicator (such as the user’s mobile phone, see Figure 13 and para. [0046]-[0047] of Malone) based on the comparison of the received compliance data and the predetermined compliant conditions (compliance being determined based on the sensor(s) 2) further comprises: determining that the received compliance data does not meet the predetermined compliant conditions (“reminders to continue should the sensor network detect the patient has stopped before the prescribed terminal point” see para. [0047] of Malone); and transmitting control signals configured to cause a speaker device associated with the joint manipulation device system to emit a first audible alert to the user (“The system may be able to send reminders, alerts, and other pertinent information to a patient during the therapy session … Such alerts and reminders may be in the form of phone notifications, emails, text messages, automated phone calls, or other electronic communication modalities” see para. [0047] of Malone. At least the automated phone calls would read on a speaker device associated with the joint manipulation system, as the user’s phone is receiving sensor data and providing feedback about the usage of the joint manipulation system), wherein the first audible alert is associated with non-compliant use of the joint manipulation device (“reminders to continue should the sensor network detect the patient has stopped before the prescribed terminal point” see para. [0047] of Malone. Stopping before the prescribed terminal point is non-compliant use).
Regarding claim 4, the modified Malone/Noda device discloses wherein providing an indication of a compliant status to the user at an indicator (such as the user’s mobile phone, see Figure 13 and para. [0046]-[0047] of Malone) based on the comparison of the received compliance data and the predetermined compliant conditions (compliance being determined based on the sensor(s) 2) further comprises: determining that the received compliance data does meet the predetermined compliant conditions (“Session Compliance: 100%” see Fig. 13; see also ”Session Complete” in the first sentence of [0048] of Malone); and transmitting control signals configured to cause a speaker device associated with the joint manipulation device system to emit a second audible alert to the user (“The system may be able to send reminders, alerts, and other pertinent information to a patient during the therapy session … Such alerts and reminders may be in the form of phone notifications, emails, text messages, automated phone calls, or other electronic communication modalities” see para. [0047] of Malone. At least the automated phone calls would read on a speaker device associated with the joint manipulation system, as the user’s phone is receiving sensor data and providing feedback about the usage of the joint manipulation system), wherein the second audible alert is associated with compliant use of the joint manipulation device (the alerts “may include compliance related information during a session.” Malone additionally states “Messages of encouragement and motivation also may be delivered to the patient” see the last sentence of [0048]. One of ordinary skill in the art would recognize that these alerts/messages could be used to relay both positive and negative reinforcement).
Regarding claim 5, the modified Malone/Noda device discloses wherein the one or more processing devices (data acquisition modules 22, patient and therapist client devices 62, 64, Figs. 14-16 of Malone) are further configured to execute computer-readable computer program code to: compare the effectiveness data with predetermined goals associated with compliance of the user in operating the joint manipulation device (“progress and goals may be displaced on screen” see the penultimate sentence of [0048], and see “Session Information” in Figure 12 listing “Target Repetitions”, “Target Time” which are also goals); determine, based on the comparison, that a feature of the joint manipulation device needs to be adjusted to meet one of the predetermined goals; and in response to determining that the feature needs to be adjusted, transmitting control signals configured to cause the joint manipulation device to adjust the feature (see Figure 12, the “Target Repetitions” goal is compared to “Repetitions Completed” and the “Target Time” goal is compared to the “Time Elapsed” to show “Time Remaining.” Additionally, Malone states in para. [0024] that a variety of feedback may be provided, such as “patient initiation and cessation of a physical therapy regime, start and stop times, how accurately the patient performs the prescribed actions, range of motion based on array of sensors, positioning of the patient limbs on the device, positioning of the patient’s body with respect to the device, orientation of the device with respect to support surfaces,” etc. Thus, when a feature of the joint manipulation device needs to be adjusted, feedback is provided to the device and its associated client devices to cause the feature to be adjusted).
Regarding claim 6, the modified Malone/Noda device discloses wherein the one or more processing devices (data acquisition modules 22, patient and therapist client devices 62, 64, Figs. 14-16 of Malone) are further configured to execute computer-readable program code to: receive input from the one or more third party systems (input may be provided by the therapist client device as seen in Figure 12; The interface “may be automatically populated from other sources, such as orders from a physician … The interface may have links or buttons for the therapist to make notes on the session in question” para. [0045]), wherein the input comprises a recommendation to adjust a feature of the joint manipulation device to maintain compliance from a medical professional associated with the user (the interface allows the physician to enter notes on the session, and “any non-compliance may be identified and acted upon during the session in question. This may allow the therapist or patient to immediately bring the therapy into compliance during the session” see para. [0022]. Thus, the recitation of intended use is met because the therapist can enter notes to suggest how to maintain compliance); and in response to receiving the input, transmit control signals configured to cause the joint manipulation device to adjust the feature (Malone states in para. [0024] that a variety of feedback may be provided, such as “patient initiation and cessation of a physical therapy regime, start and stop times, how accurately the patient performs the prescribed actions, range of motion based on array of sensors, positioning of the patient limbs on the device, positioning of the patient’s body with respect to the device, orientation of the device with respect to support surfaces,” etc. Thus, when a feature of the joint manipulation device needs to be adjusted, feedback is provided to the device and its associated client devices to cause the feature to be adjusted) or to cause communication of a notification to a device technician to adjust the feature (the notes are communicated to the patient via the patient portal, Figs. 12-13. Furthermore, the device can provide a variety of alerts/notifications to user(s), see para. [0047]).
Regarding claim 7, the modified Malone/Noda device discloses wherein the one or more processing devices (data acquisition modules 22, patient and therapist client devices 62, 64, Figs. 14-16 of Malone) are further configured to execute computer-readable computer program code to: receive compliance data corresponding to a joint manipulation device system associated with compliant operation of a joint manipulation device by a user (sensor(s) 2 of Malone “may detect placement of the limb (e.g., via pressure), and may send signals to a data logger for tracking patient compliance” (see the penultimate sentence of [0041], and “non-compliance may be identified and acted upon during the session in question,” see lines 5-10 of [0022] of Malone); and compare the received compliance data with predetermined compliant conditions (one of ordinary skill in the art would recognize that a certain number and/or amount of pressure read from the sensors 2 will be predetermined to indicate the proper placement of the limb, see the penultimate sentence of [0041] of Malone); and wherein the compliance data comprises at least a pressure exerted between a limb engaging member of the joint manipulation device and a portion of a limb of the user associated with the joint of the user (sensor(s) 2 detect a pressure exerted between a limb engaging member such as pad 6, Fig. 1; see the penultimate sentence of [0041] of Malone).
Regarding claim 9, it is noted that claim 1 only recites the “range of motion data” in the alternative (“progress data comprises at least one of…”), and claim 9 does not require that the progress data include range of motion data. Thus, the modified Malone/Noda device satisfies the limitations of claim 9 because the “range of motion data” is not positively required. Furthermore, the modified Malone/Noda device discloses wherein the range of motion data comprises a minimum and a maximum degree of rotation for the joint of the user (range of motion is calculated based on sensor data as stated in the last two sentences of [0041] of Malone. This will necessarily involve a minimum and maximum. Alternatively, Noda measures minimum and maximum angles of rotation when determining a range of motion, see for example para. [0072]), as measured by one or more sensors of the joint manipulation device system (2 of Malone, 7 of Noda).
Regarding claim 10, it is noted that claim 1 only recites the “time data” in the alternative (“progress data comprises at least one of…”), and claim 10 does not require that the progress data include time data. Thus, the modified Malone/Noda device satisfies the limitations of claim 10 because the “time data” is not positively required. Furthermore, the modified Malone/Noda device discloses wherein the time data comprises one or more periods of time during which the joint manipulation device system was operated in compliance with predetermined compliant conditions (as modified by Noda, the sensed data will exclude time(s) when the system was operated in a non-compliant manner, and thus include time(s) when the system was operated in compliance. Furthermore, Figs. 12-13 of Malone show the system is tracking one or more periods of time during which the device is operated in compliance).
Regarding claim 11, the modified Malone/Noda device discloses wherein the effectiveness data is transmitted to one or more doctors, physical therapists, or insurance provider organizations associated with the user or the joint manipulation device system (the data is able to be transmitted through data acquisition unit 22, server 58, cloud 60, to various patient and therapist clients 62, 64, Figs. 14-16; see para. [0049]. For example, as seen at the therapist’s mobile phone application in Fig. 12 of Malone).
Regarding claim 12, the modified Malone/Noda device discloses wherein the progress data are received from the joint manipulation device system (from the sensor(s) 2 of the joint manipulation device system, see Fig. 1 of Malone; “sensors 2 may maintain communication with other network devices through a data acquisition module 22 that attaches to the therapy device 4 being used. Such a module may act as a data acquisition device for data collection, conditioning, and transmission … may use wired or wireless protocols for communication with the sensors 2 and other devices in the network” see para. [0044] and Figs. 14-16).
Regarding claim 13, the modified Malone/Noda device discloses wherein the system comprises a mobile device (patient or therapist clients 62, 64, Figs. 14-16, may be smart phones, see para. [0044], [0050], and Figs. 12-13 of Malone) running an application for receiving the compliance data and progress data as inputs self-reported by the user (see Figs. 12-13 of Malone, illustrating a smart phone application that receives compliance and progress data. The user is able to self-report data, see the “Patient Input” section of the application in Figure 13 with “Pain Level” and “Comments”).
Regarding claim 14, it is noted that claim 1 only recites the “range of motion data” in the alternative (“progress data comprises at least one of…”), and claim 14 does not require that the progress data include range of motion data. Thus, the modified Malone/Noda device satisfies the limitations of claim 14 because the “range of motion data” is not positively required. Furthermore, the modified Malone/Noda device discloses wherein the range of motion data comprises a minimum and a maximum degree of rotation for the joint of the user (range of motion is calculated based on sensor data as stated in the last two sentences of [0041] of Malone. This will necessarily involve a minimum and maximum. Alternatively, Noda measures minimum and maximum angles of rotation when determining a range of motion, see for example para. [0072]), as measured from one or more pictures (as taught by Noda’s motion capture detection) taken by the user using the application running on the mobile device (this is a method step recited in an apparatus claim, and it is reiterated that the “range of motion data” is not positively required, and thus the intended picture taking step is similarly not required).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Malone et al. (2018/0271436) in view of Noda et al. (2018/0153445) as applied to claim 7 above, and further in view of Avni et al. (2018/0312549).
Regarding claim 8, the modified Malone/Noda device discloses wherein the compliance data meets the predetermined compliant conditions based upon the pressure exerted between the limb engaging member of the joint manipulation device and the portion of the limb of the user associated with the joint of the user (sensor(s) 2 detect a pressure exerted between a limb engaging member such as pad 6, Fig. 1; see the penultimate sentence of [0041] of Malone). The modified device does not specifically state this is when the pressure is at or above a predetermined threshold pressure value.
Avni teaches a related rehabilitation system (Fig. 1B) in which the patient interface includes pressure sensors (sensors 130, Fig. 1A; “Sensors 130 may sense, for example, forces exerted by patient 110 on one or more of the cuffs” see para. [0242]); and the system determines if a compliance threshold is reached based upon an exerted force being above a target threshold (“if a compliance threshold is reached (e.g., the exerted force is above a target threshold), the processor may control the robot to speed up the walking pace, so as to train the patient in faster walking.” See para. [0256]).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the sensor network of Malone/Noda to utilize a predetermined threshold pressure value as taught by Avni to determine whether the patient is applying sufficient force/pressure to the joint manipulation device.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-14 and 27 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-27 of U.S. Patent No. 11,957,481, in view of Malone et al. (2018/0271436), Noda et al. (2018/0153445), and Avni et al. (2018/0312549).
Although the claims at issue are not identical, the instant claims are merely broader versions of the patented claims. For example, instant claim 1 omits “receive compliance data corresponding to a joint manipulation device system associated with compliant operation of a joint manipulation device by a user”, “compare the received compliance data with predetermined compliant conditions.” Furthermore, to any extent that the dependent claims recite element(s) not disclosed by claims 1-27 of U.S. Patent No. 11,957,481, Malone, Noda, and/or Avni teach the remaining limitation(s) (see the 35 USC 103 rejection(s) above), and the feature(s) would merely provide expected results.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Zhao et al. (2017/0360636) discloses a rehabilitation device that has a data harvesting unit that excludes data considered “ineffective or outside a predetermined tolerance range.” Hyde et al. (2013/0043993) discloses a related system that excludes a portion of sensor data if that portion of data is apparently useless. Rubinstein et al. (2019/0295436) discloses a related exercise feedback system that may classify or label certain exercises as improper form. Goldfain (2016/0174099) discloses a wearable device with a system of marking, flagging, or otherwise indicating that data is unacceptable for use in calculating a metric. Hughes et al. (2015/0302162) discloses a related rehabilitation system that has an embedded camera that can be part of a smart phone to take one or more photos of the patient’s injury. Peles (2004/0243025) discloses a related arm rehabilitation device that detects force/angle data and responsive to the data, updates at least one parameter of the treatment session. Denson et al. (2017/0100301) discloses a compression garment that has sensor(s) to determine if the garment is in a wrapped configuration or if it is not being worn properly, and to indicate a data recording as compliant if the device is worn properly. Zaharkin et al. (5,474,088) discloses a related joint angle detection device with an indicator to provide feedback. Bhugra et al. (10,179,078) discloses a related range of motion rehabilitation device that discards unusually good or bad data.
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/CHRISTOPHER E MILLER/ Examiner, Art Unit 3785
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