Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
Applicant has submitted amendments to the claims on 12/10/2025.
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) 1-28 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cramer et al (US PUB. 20170069223, herein Cramer) in view of Killin et al (US PUB. 20170069223, herein Killin) in further view of Brown et al (US PUB. 20200350076, herein Brown).
Regarding claim 1, Cramer teaches A treatment apparatus, comprising:
a machine configured to be manipulated by a patient to perform a regimen for rehabilitation of the patient, wherein the regimen corresponds to a regimen for a body part, the body part comprising at least one of a joint, a bone, and a muscle group (fig. 10, fig. 1, 0050-0057);
and one or more internal sensors configured to generate data indicating performance of the regimen by the patient (0030 “the motion tracking system can be a further motion tracking system that includes a further camera, such as the camera or motion tracking sensor 56 mounted to the top of the computer/monitor”),
wherein the machine is configured to:
receive at least one of a first input from a clinician interface and a second input from a patient interface, wherein (i) the first input corresponds to a prompt, presented on the clinician interface, to modify the regimen, wherein the modification of the regimen is based on the data indicating performance of the regimen (0201 “system is modular and open to reconfiguration and personalization. The same system can be used to treat patients with many different diagnoses and can be adjusted and personalized (by the therapist, patient, or both) to be useful to persons with any degree of disease severity”, 0199 “A wide variety of information can be provided to the physical therapist. As is apparent from the figures, the information can include the total therapy sessions, the fractions of these sessions that were supervised or unsupervised, the start date of the therapy, the last day of the therapy, the exercises performed, the games played, the user interface devices used, patient compliance, patient game scores, images of the patient performing activities, etc. Generally speaking, any data that can be collected by the patient workstation can be presented to the physical therapist to assist him or her in facilitating the patient's recovery to the greatest extent possible”).
The cited prior art do not teach and (ii) the second input corresponds to at least one response to a plurality of questions, presented on the patient interface, pertaining to a current or past physical condition of the patient, and responsive to the at least one of the first input and the second input, selectively stop or prevent operation of the machine by the patient and responsive to at least one of the first input and the second input, transmitting an alert message including pseudonymized data, anonymized data, or both to the clinician interface.
Killin teaches and (ii) the second input corresponds to at least one response to a plurality of questions, presented on the patient interface, pertaining to a current or past physical condition of the patient (0035-0040, 0030 “he user can also communicate answers or responses through a Personal Digital Assistant (PDA) or a wireless phone. In yet another embodiment the user would respond, as prompted, to the questions that are verbally presented. In an alternative embodiment, the user can respond to prompts from the system 10 based on a list of written questions that the user previously received”) ,
responsive to the at least one of the first input and the second input, selectively stop or prevent operation of the machine by the patient (0042 “Questions can be weighted based upon many factors, such as relevance to the particular assessment and/or time since the injury and/or surgery As the user performs a reassessment, a recalculation is preferably performed to determine an updated exercise or plan of care”, 0015 “present invention also provides computer guided questions, the answers to which provide time based assessments resulting in exercise therapy and related care plans for specific wellness, general health, diseases, pre-employment physical capacity tests, prevention of repetitive stress”)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to have modified the teachings of Cramer with the teachings of Killin since Killin teaches a means for improving “physical and functional capabilities” of a user (0015).
The cited prior art do not teach and responsive to at least one of the first input and the second input, transmitting an alert message including pseudonymized data, anonymized data, or both to the clinician interface.
Brown teaches and responsive to at least one of the first input and the second input, transmitting an alert message including pseudonymized data, anonymized data, or both to the clinician interface (0025 “mechanism of action may include sending an alert to a healthcare provider device associated with a healthcare provider supervising the patient”, 0042 “he patient record 105 may be encrypted while stored on the data storage 158 so that any information identifying the patient 101 is anonymized, but may later be decrypted when the patient 101 or supervising HCP 109 requests the patient record 105 (assuming the requester is authorized/authenticated to access the patient record 105). All data transmitted over the network 106 between the patient device 102 and the cloud computing system 150 may be encrypted and sent over secure communication channels. For instance, the patient application 103 may encrypt the event data 122 before transmitting to the therapy service 160 via the HTTPS protocol and decrypt a patient record 105 received from the therapy service 160. When network connectivity is not available, the patient application 103 may store the event data 122 in an encrypted queue within the memory hardware 114 until network connectivity is available”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to have modified the teachings of Cramer and the teachings of Killin with the teachings of Brown since Brown teaches a means for alerting clinicians of situations and providing the information in a secure manner (0025 0042).
Regarding claim 2, the cited prior art teach The treatment apparatus of claim 1.
Cramer teaches wherein the regimen is a physical rehabilitation regimen for improving strength or range of motion of the body part (0044 “he therapist control system presents potential activities for the patient based upon the particular needs of the patient (e.g., decreased grip strength)”).
Regarding claim 3, the cited prior art teach A system comprising the treatment apparatus of claim 1.
Cramer teaches and further comprising the clinician interface, wherein the clinician interface comprises a patient profile display configured to present the data and the prompt (0199 “A wide variety of information can be provided to the physical therapist. As is apparent from the figures, the information can include the total therapy sessions, the fractions of these sessions that were supervised or unsupervised, the start date of the therapy, the last day of the therapy, the exercises performed, the games played, the user interface devices used, patient compliance, patient game scores, images of the patient performing activities, etc. Generally speaking, any data that can be collected by the patient workstation can be presented to the physical therapist to assist him or her in facilitating the patient's recovery to the greatest extent possible”).
Regarding claim 4, the cited prior art teach The system of claim 3.
Killin teaches further comprising the patient interface, the patient interface comprising an output device and an input device for respectively transmitting and receiving, to and from the patient, information regarding the performance of the regimen implemented by using the treatment apparatus (0030 “user can perform an assessment, preferably in substantially real-time at a single session, and using any of the devices 40 to communicate the information to the system 10, wherein the application program will receive and read the data that is later stored in the database. The user can also communicate answers or responses through a Personal Digital Assistant (PDA) or a wireless phone”), wherein the patient interface is configured to present (i) instructions and status information to the patient regarding the performance of the regimen (0042 “algorithms determine that the person should be referred to a health care provider, then at step 106 the user is provided instructions to contact a health care provider. In one embodiment, the user would simply receive instructions to contact a health care provider, while in another embodiment, the user is provided with a choice of health care providers located near the user and at step 108 the information provided by the user, in response to the questions, is forwarded to the healthcare provider selected by the user”) and (ii) a questionnaire soliciting the patient to answer the plurality of questions (0030 “user can perform an assessment, preferably in substantially real-time at a single session, and using any of the devices 40 to communicate the information to the system 10, wherein the application program will receive and read the data that is later stored in the database. The user can also communicate answers or responses through a Personal Digital Assistant (PDA) or a wireless phone”).
Regarding claim 5, the cited prior art teach The system of claim 4.
Killin teaches wherein the system is configured to take an action in response to a selected response to one of the plurality of questions (0042 “algorithms determine that the person should be referred to a health care provider, then at step 106 the user is provided instructions to contact a health care provider. In one embodiment, the user would simply receive instructions to contact a health care provider, while in another embodiment, the user is provided with a choice of health care providers located near the user and at step 108 the information provided by the user, in response to the questions, is forwarded to the healthcare provider selected by the user”).
Regarding claim 6, the cited prior art teach The system of claim 5.
Cramer teaches wherein the action comprises transmitting an alert to a clinician (0213 “The system also can generate regular progress reports, which can focus on patient goals, therapist goals, or feedback (to patient or therapist) of patient performance and usage statistics”).
Regarding claim 7, the cited prior art teach The system of claim 6.
The cited prior art teach wherein the alert to the clinician comprises an alert message (Cramer 0213 “The system also can generate regular progress reports, which can focus on patient goals, therapist goals, or feedback (to patient or therapist) of patient performance and usage statistics”), the alert message including information relating to the selected response to the one of the plurality of questions (Killin 0042 “the user is provided with a choice of health care providers located near the user and at step 108 the information provided by the user, in response to the questions, is forwarded to the healthcare provider selected by the user”).
Regarding claim 8, the cited prior art teach The system of claim 7.
Cramer teaches wherein the alert to the clinician comprises a real-time communication to the clinician outside of the clinician interface (0038 “the data can be transmitted with the network interface device 26 over the network 14 to the server 18 (FIG. 1). The data can be transmitted in a variety of ways. In some embodiments, the data can be transferred in real time as it is collected”).
Regarding claim 9, the cited prior art teach The system of claim 5.
Killin teaches wherein, before the action is taken, the patient interface presents a prompt for the patient to confirm the selected response to the one of the plurality of questions (0030 “user can perform an assessment, preferably in substantially real-time at a single session, and using any of the devices 40 to communicate the information to the system 10, wherein the application program will receive and read the data that is later stored in the database. The user can also communicate answers or responses through a Personal Digital Assistant (PDA) or a wireless phone”).
Regarding claim 10, the cited prior art teach The system of claim 4.
Cramer teaches wherein the patient interface and the treatment apparatus are each configured to enable operation of the machine from a patient location geographically separate from a location of the clinician interface (0021 “the therapist can provide online synchronous personal assistance to the patient in his or her home even through the therapist is in a different location”).
Regarding claim 11, the cited prior art teach The system of claim 4.
Killin teaches wherein predetermined responses to the plurality of questions must be provided before the patient is authorized to use the treatment apparatus ((0042 “algorithms determine that the person should be referred to a health care provider, then at step 106 the user is provided instructions to contact a health care provider. In one embodiment, the user would simply receive instructions to contact a health care provider, while in another embodiment, the user is provided with a choice of health care providers located near the user and at step 108 the information provided by the user, in response to the questions, is forwarded to the healthcare provider selected by the user”).
Regarding claim 12, the cited prior art teach The system of claim 4.
The cited prior art teach wherein the patient interface comprises a session period action screen configured to present a real-time status of measurements regarding use of the treatment apparatus by the patient, wherein the patient interface generates a triggering event based on the measurements (Cramer 0211 “system can further provide feedback that can come in many forms, be in real time, and be used to improve future performances. As an extension of this, real-time measures of patient performance can be used to adjust the difficulty level of rehabilitation games and exercises on the fly according to pre-selected rules”), and wherein the patient interface presents a help display in response to the triggering event (Killin 0043 “If it is determined that the user is not having or has not recently had surgery, then at step 120 the non-surgical users are given instructions via audio, text and video on program use and questions, which if answered appropriately will allow the user access to the program routine for non-surgical users. If the answer is not appropriate for continued use, the user is referred to a health care provider”, 0073 “related scoring in the example of the initial assessment in FIG. 4 would be displayed in audio and video along with text. The system automatically takes the user to the appropriate Phase of care for the specific concern and body area. An example of an initial assessment as reported to the user is shown in the text below: Stop Here: Your score is 30 or less, ***STOP***. Go to Exercise Program Phase 1. DO NOT continue with the rest of this assessment.”).
Regarding claim 13, the cited prior art teach The system of claim 12.
Killin teaches wherein the help display includes (ii) a first control for the patient to stop using the treatment apparatus or to request additional help in using the treatment apparatus and (ii) a second control for the patient to continue using the treatment apparatus (0043 “If it is determined that the user is not having or has not recently had surgery, then at step 120 the non-surgical users are given instructions via audio, text and video on program use and questions, which if answered appropriately will allow the user access to the program routine for non-surgical users. If the answer is not appropriate for continued use, the user is referred to a health care provider”, 0073-0075).
Regarding claim 14, the cited prior art teach The treatment apparatus of claim 1.
The cited prior art teach wherein the one or more internal sensors include an internal sensor configured to measure at least one of a linear motion and an angular motion of the body part of the patient (0030 “the motion tracking system can be a further motion tracking system that includes a further camera, such as the camera or motion tracking sensor 56 mounted to the top of the computer/monitor 22. A commercial example of a further motion tracking system is the Nintendo Wii™. Notably, in addition to tracking “shots” from the gun controller 54, the Wii™ tracking system can be positioned in different locations and configured to track movement of the patient's head, torso, and limbs”), and wherein the plurality of questions includes a question based on a measurement by the internal sensor (Kllin 0035 “If yes to any of the above 3 questions, you should have additional medical screening for other potential problems. If you have had additional screening and have been cleared to participate in a rehab program, please continue. Do you have numbness, tingling or pain in your thigh, leg or foot that change with changes in posture, position or activity?”).
Claims 15-28 are rejected using similar reasoning as the rejection of claims 1-14 due to reciting similar limitations but directed towards a method.
Response to Arguments
Applicant’s arguments, filed 12/10/2025, with respect to the rejection(s) of claim(s) 1 under 35 USC 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Cramer et al (US PUB. 20170069223, herein Cramer) in view of Killin et al (US PUB. 20170069223, herein Killin) in further view of Brown et al (US PUB. 20200350076, herein Brown).
Applicant argues that the cited prior art fail to teach the amendments to the claims.
However, as a result of further search and consideration, Brown has been introduced. Brown teaches a means for clinicians to get alerts about patient health data (0025). Brown further teaches patient record is stored anonymously (0041). Therefore, the cited prior art teach the broadest reasonable interpretation of the argued limitation.
Therefore, claim 1 and its dependent claims are rejected. Claims 15-28 are similar and are similarly rejected.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/TAMEEM D SIDDIQUEE/
Primary Examiner
Art Unit 2116