Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 1, 7, 13 and 17 recite the limitation "the protocol" in lines 13, 12, 2 and 9, respectively. There is insufficient antecedent basis for this limitation in the claim.
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.
Claims 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over Matos (20140371816) in view of Reich et al. (20140194250).
Regarding claim 1, Matos teaches a computer-implemented system (Fig. 1A, pars. 28, 207 - IMD system), comprising:
an electromechanical device (Fig. 1A – IMD) configured to be manipulated by a user, (Fig. 1A, pars. 34-40, 207-209 – the IMD/electromechanical device is used by patient/user);
an interface comprising an output device configured to present information (Fig. 1A-104, Fig. 2-222, Fig. 4A-402, pars. 228-234, 253);
and a processing device configured to: receive a treatment plan for a user, wherein the treatment plan is generated by an artificial intelligence engine (Par. 218 – teaches that the automated device provides expert medical guidance, including comparing potential therapeutic plans, which could be interpreted as treatment plans. It can also evaluate and develop neural network-based approaches, which is an artificial intelligence engine. Pars. 303-323 teach that the IMD may run a treatment determining algorithm, where the algorithm may include a medical profession’s recommendation (par. 311) and entail neural network style learning features (par. 313). The recommendation of the algorithms can also use weighted rankings of the different types of treatment options (pars. 315-318). Par. 393 teaches that treatment instructions are output. Pars. 454-457 teach using different tiers of therapy (therapy is a treatment plan);
during a session, use the treatment plan to generate at least one parameter (Fig. 5, par. 51 teaches of treatment parameters. Pars. 258-259, 262-276 - during a session, a patient/user uses a contact device that sends information to the patient device/processing device to generate at least one parameter such as ECG, skin resistance, blood pressure, and information from accelerometer. Pars. 388-292 teach that information may be analyzed which predict successful treatment outcomes, and uses parameters from those treatment plans, such as sensor signals and clinical data (par. 391), to form a basis of a treatment recommendation. That is, a treatment plan will always provide some type of parameter to achieve a result);
and responsive to at least one trigger condition occurring, control based on the at least one parameter and using the artificial intelligence engine, at least one operation while the electromechanical device is operating, to facilitate user compliance with the protocol (treatment plan) (Figs. 23-24, pars. 64, 624 and 627 - triggering condition can be when the heart rate is greater than a threshold, and then the treatment threshold and interrogating a patient threshold will be lower. Fig. 25, pars. 646-648 - the patient response time can be one of the trigger conditions. If the patient does not reply within a given time interval, the IMD can select an aggressive therapy such as high energy shock which might lead to increasing pressure. Par. 793 - the patient/user or medical profession can adjust the treatment plan given by the IMD/electromechanical device based on the triggered condition and the best option for the patient to follow. Par. 825 - the patient can adjust the treatment plan offered by ICD/electromechanical device. It will make it easier for the patient to follow the treatment plan since the patients are aware of their health and can choose what is best for them. See Fig. 78 as an example, pars.1007-1012 - the patient device/ processing device can adjust insulin dosage if both patient and IMD/electromechanical device have not managed the insulin dosage with satisfactory result. Pars 315-327 also teach that control signals are input to a master IMD algorithm, which includes a treatment choice.).
Although Matos does teach that the personal medical device (PMD) can refer to a medical device outside of the body (Par. 206), Matos does not explicitly teach of a PMD that comprises 1) an electromechanical device which comprises at least one pedal, 2) during a session, the parameter comprising a range of motion to be provided by the at least one pedal, and 3) responsive to at least one trigger condition occurring, control at least one operation associated with the at least one pedal.
Reich et al. teaches of a therapy system that includes an electromechanical device, wherein the electromechanical device comprises one pedal (Fig. 4- see exercise bike/electromechanical device comprises pedals 450), a processing device configured to:
during a session, use a treatment plan (rehabilitation/physical therapy plan (set exercise program) – Abstract, pars. 55-62, 216) to generate at least one parameter comprising a range of motion to be provided by the at least one pedal (Figs. 3-5, pars. 79, 88, 124 and 151-153 - the device parameter (such as rate of movement/range of motion) can be adjusted based on sensed patient conditions).
and responsive to at least one trigger condition occurring, control based on the at least one parameter, at least one operation associated with the at least one pedal (Par. 88 - the electromechanical device can be controlled and adjusted based on the sensors output information including “a position, velocity, and/or acceleration of a moveable element of the resistance system, a force applied to a portion of the exercise system” which can be associated with pedal. Also, the electromechanical device can be responsive to a trigger condition, “for example, the heart rate of the user is measured using a heart rate monitor and the physical resistance supplied by the electric motor is varied to maintain the heart rate in a target zone.”)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Matos by incorporating the teaching of Reich so that the electromechanical device taught by Matos could further be part of a rotational movement system. This would have been obvious because both Matos and Riech are associated with therapy systems that comprise programs that provide control to an electromechanical device via sensors and can also be monitored by a remote medical professional (Matos – Pars. 208-209, 425-428; Reich – Pars. 124, 208, 216), and further, doing so would allow the system of Matos to expand medical options to include rehabilitation using enhanced exercise performance (Reich - Abstract, par. 41).
Regarding claim 2, Matos in view of Reich teach the system of claim 1, wherein the electromechanical device comprises a sensor for detecting data associated with the at least one operation (Matos et al., Fig. 4A-416, par. 251 - IMD/ electromechanical device includes a sensor).
Regarding claim 3, Matos in view of Reich teach the system of claim 2, wherein the processing device is configured to receive the data from the sensor in real-time or near real-time (Matos et al., Fig. 4A, par. 253 - as shown in FIG. 4A, patient device/ processing device can communicate with IMD/electromechanical device via relay 406, 408, 410. Therefore, the processing device can receive data from a sensor, via those relays, in real-time or near real time. Pars. 262-263 - processing device/patient device receive information from the sensor. Fig. 6, pars. 278, 284 - patient device/processing device receive sensor information from the IMD/electromechanical device).
Regarding claim 4, Matos in view of Reich teach the system of claim 3, wherein, to determine the at least one trigger condition, the one or more processing devices are configured to use at least one of the data, the at least one parameter, and a user input (Matos et al., Figs. 4A, 5 and 6, pars. 262-276 - processing device/patient device receive at least one parameter such as ECG, skin resistance, blood pressure, and information from accelerometer. Par. 291 - processing device can receive a protocol/information/instruction for a patient/ user. Par. 528 - the patient device/processing device can receive sensor data and patient interrogation data. Figs. 21, 23 and 24, par. 627 - one of the trigger conditions can be when the heart rate is greater than 180. Thus, if the processing device can receive information about the data parameter and user input, it can determine at least one trigger condition using that information. For instance, the ECG information can be used to determine whether the patient’s heart rate is greater than 180 or in normal condition).
Regarding claim 5, Matos in view of Reich et al. teaches the system of claim 1, wherein the controlling of the at least one operation of the electromechanical device comprises causing the electromechanical device to modify at least one of a volume, a pressure, a resistance, an angle, a speed, an angular or rotational velocity, and a time period (Matos et al., Figs. 5, 16-20, pars. 262-276, 452, 460 - if the patient condition is not good, the ICD/electromechanical device can modify the therapy which leads to affect the patient’s blood pressure or respiratory rate. Pars. 462-486 - patient assessments are used to determine the patient’s condition, and the ICD/ electromechanical device can be programmed based on the patient assessments to modify at least one of a volume, a pressure, etc. Par. 601 - shock frequency- time period).
Regarding claim 6, Matos in view of Reich et al. teaches the system of claim 1, wherein the at least one parameter is at least one of a force parameter, a resistance parameter, a temperature parameter, a pain level parameter, an exercise session parameter, a vital sign parameter, and a time parameter (Matos et al., Fig. 5, pars. 262-276 - ECG/vital sign, skin resistance, information from accelerometers/ range of motion, and body attitude information/ pain level parameters. Fig. 19 includes force parameter/blood pressure, vital sign/heart rate, blood gas/ temperature, blood glucose/volume, and GSR/resistance parameters. Par. 601 - shock frequency- time parameter. Fig. 25, pars. 646-648 - if the patient’s responding time is a trigger condition, time can be one of the parameters).
Claims 7-12 correspond to claims 1-6 above, respectively, and are therefore rejected on the same premises.
Regarding claim 13, Matos in view of Reich teach the system of claim 7, wherein the one or more processing devices are configured to receive the protocol (treatment plan) from a clinical portal (Matos - Fig. 1A, pars. 207-209 - patient device/processing device can communicate with health professionals through remote station/clinical portal.; Fig. 4A, pars. 252, 254 - the processing device/patient device can communicate with remote station/clinical portal, and remote station can store information such as the protocol or any information related to the patient/user. Therefore, the processing device can receive the protocol from a clinical portal/remote station).
Regarding claim 14, Matos in view of Reich teach the system of claim 7, wherein the one or more processing devices are further configured to:
transmit a notification to a clinical portal in real-time or near real-time (Matos - Fig. 4A, pars. 252, 254 - both patient device/processing device and clinical portal can receive and transmit information and communicate with each other. Therefore, patient device/processing device can transmit a notification to clinical portal/ remote station in real-time or near real time.);
receive at least one adjusted parameter in real-time or near real-time (Matos - Fig. 5, pars. 262-276 - processing device/patient device receive a sensor information of IMD/electromechanical device and ECG information. Figs. 23-24, pars. 607-624 - the heart rate/ vital sign is adjusted by ICD/electromechanical device shock. If one of the parameters can be adjusted, and processing device can receive sensor information (real-time or near real-time) about some of the parameters, then it can receive at least one adjusted parameter in real-time or near real-time.);
and using the at least one adjusted parameter, control the at least one operation of the device in real-time or near real-time (Matos - Fig. 23, pars. 619-623 - the ICD/electromechanical device delivers the second or third shock after receiving the first adjusted heart rate/vital sign parameter in real-time or near real-time. Par. 763 - processing device/patient device controls IMD/electromechanical device).
Regarding claim 15, Matos in view of Reich teach the system of claim 7, wherein the one or more processing devices are further configured to:
transmit a notification to a clinical portal (Matos - Fig. 4A, pars. 252, 254);
receive at least one adjusted parameter (Matos - Figs. 5, 23, 24, pars. 262-276, 607-624 - the processing device/patient device can receive at least one adjusted parameter such as heart rate/vital sign parameter after being shocked by ICD/ electromechanical device.);
and using the at least one adjusted parameter, control the at least one operation of the device at a time subsequent to receiving the at least one adjusted parameter (Matos - Fig. 23, pars. 619-623 - the ICD/electromechanical device delivers the second or third shock after receiving the first adjusted heart rate/vital sign parameter).
Regarding claim 16, Matos in view of Reich teach the system of claim 7, wherein the device comprises at least one of a physical therapy device, a brace, a cap, a mat, and a wrap (Matos - Fig. 1A, par. 209 - IMD can be implantable defibrillator, a pacemaker, a device for controlling blood pressure, and some other physical therapy devices).
Regarding claims 17-20, the claims recite a method corresponding to the limitations of claims 1-4 above, respectively, and are therefore rejected on the same premises.
Response to Arguments
Applicant's arguments filed 3/2/2026 have been fully considered but they are not persuasive.
The applicant states:
“Matos does not teach or suggest that a processing device receives a treatment plan for a user where the treatment plan is generated by an artificial intelligence engine, as currently recited by the amended independent claims. Indeed, Matos appears to be completely silent regarding the use of artificial intelligence, much less using artificial intelligence to generate a treatment plan. Further, since Matos is silent regarding the use of artificial intelligence at all, Matos also fails to teach or suggest controlling, based on at least one parameter and using an artificial intelligence engine, at least one operation associated with the at least one pedal, as currently recited by the amended independent claims. Reich appears to be completely silent regarding the use of artificial intelligence, and Reich does not cure the deficiencies of Matos.”
The examiner respectfully disagrees.
With respect to the applicant’s argument that Matos does not receive a treatment plan generated by an artificial intelligence engine, par. 218 teaches that the automated device provides expert medical guidance, including comparing potential therapeutic plans, which clearly could be interpreted as treatment plans. The automated device draws on a large database of information to aid in its decision making. Further, it can evaluate experimental algorithms and develop neural network-based approaches, which is an artificial intelligence engine. Pars. 303-323 further teach that the IMD may run a treatment determining algorithm, where the algorithm may include a medical profession’s recommendation (par. 311) and entail neural network style learning features (par. 313). The recommendation of the algorithms can also use weighted rankings of the different types of treatment options (pars. 315-318). Par. 393 teaches that treatment instructions are output, and pars. 454-457 teach using different tiers of therapy (therapy is a treatment plan).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See PTO-892.
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/SCOTT T BADERMAN/Supervisory Patent Examiner, Art Unit 2118
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