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 .
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1, 5, 12, 14-15, 17, 27-28, and 30 is/are rejected under 35 U.S.C. 103 as being unpatentable over Leuthardt (2014/0277582) in view of Mooney (11148279).
With respect to claim 1, Leuthardt discloses a system (100, fig 1A) for assessing a stroke rehabilitation outcome of a subject (see [0003]), the system comprising a home-based brain-controlled interface (BCI) apparatus (101, fig 1A) having a portable brain signal acquisition headset (112/114, fig 1A) that acquires a brain signal from the subject (see [0025]); an orthosis device (102, fig 1A) having a body part interface (104/108, fig 3) configured to be coupled to a body part of the subject (see [0031]), and having a plurality of sensors that generate force data and movement data (see [0048]); a BCI component that receives the brain signal from the brain signal acquisition headset, wherein the BCI component is capable of controlling the orthosis device (see [0030]); and a computer processor (CPU; 256, fig 2) in communication with the BCI apparatus (see fig 2), the computer processor performing instructions to process input data to output a rehabilitation outcome prediction for the subject (264; fig 2 and see [0060]), wherein the input data includes the brain signal, the force data, the movement data (fig 2 and [0061]), but lacks the input data including background information about the subject.
However, Mooney teaches a rehabilitation device (100, fig 1) comprising a computer processor (302, fig 3) with input including background information about the subject (see col. 26, lines 23-37).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the input of Leuthardt to include background information as taught by Mooney so as to personalize and store the user’s information within a profile.
With respect to claim 5, the modified Leuthardt shows the orthosis device comprises a motor-actuated assembly (motors; 282, fig 2 of Leuthardt) that actuates the body part interface to move the body part (see [0064]) of Leuthardt); the plurality of sensors comprises a force sensor (pressure sensor) that generates the force data (see [0048] of Leuthardt); and the force data includes forces applied between the body part interface and the motor-actuated assembly (see [0048] of Leuthardt).
With respect to claim 12, the modified Leuthardt shows all the elements as claimed above but is silent regarding a biometric sensor, wherein the input data includes data the biometric sensor.
However, Mooney teaches a rehabilitation device (100, fig 1) comprising a biometric sensor (1440, fig 14) wherein input data includes data from the biometric sensor (see col. 20, lines 31-47).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of the modified Leuthardt to include a biometric sensor as taught by Mooney so as to monitor the user’s condition and response during rehabilitation.
With respect to claim 17, Leuthardt discloses a method (system of Leuthardt capable of performing the method) for assessing a stroke rehabilitation outcome of a subject (100, fig 1A; [0003]), the method comprising a) collecting (see [0025]) a brain signal, force data and movement data from a home-based brain- controlled interface (BCI) apparatus (101, fig 1A); and b) processing input data (CPU; 256, fig 2), using a computer processor that performs instructions for the processing (see [0030]), wherein the input data comprises the brain signal, the force data and the movement data to output a rehabilitation outcome prediction for the subject (264; fig 2 and see [0060]); wherein the home-based BCI apparatus includes i) a portable brain signal acquisition headset that acquires the brain signal (112/114, fig 1A); ii) an orthosis device (102, fig 1A) having a body part interface (104/108, fig 3) configured to be coupled to a body part of the subject (see [0031]), and having a plurality of sensors that generate the force data and the movement data (see [0048]); and iii) a BCI component that receives the brain signal from the brain signal acquisition headset, wherein the BCI component is capable of controlling of the orthosis device (see [0030]) but lacks the input data including background information about the subject.
However, Mooney teaches a rehabilitation device (100, fig 1) comprising a computer processor (302, fig 3) with input including background information about the subject (see col. 26, lines 23-37).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the input of Leuthardt to include background information as taught by Mooney so as to personalize and store the user’s information within a profile.
With respect to claims 14 and 27, the modified Leuthardt shows the rehabilitation outcome prediction comprises a compatibility of the subject with the BCI apparatus (see [0035] of Leuthardt ‘predict the patient's response to a rehabilitation regime’).
With respect to claims 15 and 28, the modified Leuthardt shows the instructions comprise outputting a modification to a rehabilitation program used by the subject, based on the rehabilitation outcome prediction (see ‘feedback’ in [0047] of Leuthardt).
With respect to claim 30, the modified Leuthardt shows repeating the collecting to collect updated brain signals, updated force data and updated movement data from the home-based BCI apparatus; and revising instructions for processing the input data based on the updated brain signals, the updated force data and the updated movement data (see storing in memory and providing feedback [0051 and 61] of Leuthardt).
Claim(s) 2 and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Leuthardt in view of Mooney as applied to claims 1 and 17 above, and further in view of Bhugra (2021/0106490).
With respect to claims 2 and 18, the modified Leuthardt shows the BCI apparatus further comprises a control system (control module; 272, fig 2 of Leuthardt) configured to operate the orthosis device in a BCI mode in which the orthosis device operates to move or assist in a movement of the body part based on an intention of the subject determined from an analysis of the brain signal (‘free assist mode’ see [0049] of Leuthardt); and a volitional mode (free mode of operation) in which the orthosis device first allows the subject to move or attempt to move the body part in a predefined motion and then operates to move or assist in the predefined motion of the body part (see [0088] of Leuthardt) but lacks a continuous passive mode in which the orthosis device operates to move the body part with no volition from the subject.
However, Bhugra teaches a system (fig 1A) comprising a control system (305, fig 3A) configured to operate an orthosis device (106/108, fig 1A) in a continuous passive mode (387, fig 3C) in which the orthosis device operates to move the body part with no volition from the subject (see [0007]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the control system of the modified Leuthardt to include a continuous passive mode as taught by Bhugra so as to work the body part without making the user put in much effort.
Claim(s) 3 and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Leuthardt, Mooney, and Bhugra as applied to claims 2 and 18 above, and further in view of Zheng (CN107440887).
With respect to claim 3, the modified Leuthardt shows the force data measured by a force sensor in the plurality of sensors during the BCI motor-generated movement (see [0048] of Leuthardt), but lacks the input data comprises a somato-sensory evoked potential (SSEP), wherein the computer processor determines the SSEP from the brain signal acquired as a result of a BCI motor-generated movement.
However, Zheng teaches a system (see fig 1) comprising input data comprises a somato-sensory evoked potential (SSEP) (head array is on the somatic sensory center; see [0024]), wherein the computer processor determines the SSEP from the brain signal acquired as a result of a BCI motor-generated movement (see [0015 and 24]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the input data of the modified Leuthardt to include somato-sensory evoked potential as taught by Zheng so as to acquire signals from a specified part of the user’s anatomy to accurately control and manipulate the system.
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Leuthardt and Mooney as applied to claim 1 above, and further in view of Kelly (2020/0360169).
With respect to claim 4, the modified Leuthardt shows all the elements as claimed above but lacks the plurality of sensors comprises an accelerometer and the movement data includes acceleration data from the accelerometer.
However, Kelly teaches an orthosis (100, fig 1) comprising an accelerometer (IMU senses acceleration; 180, fig 5) and movement data includes acceleration data from the accelerometer (see [0057]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the plurality of sensors of the modified Leuthardt to include an accelerometer as taught by Kelly so as to monitor and control the device based on the acceleration.
Allowable Subject Matter
Claims 7-8 objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The closest prior art of record does not specifically disclose the claimed device and function as presented in claims 7-8, 10-11, 13, 16, 21-22, 24-26 and 29 and to modify would be improper hindsight.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. WO2011/123059, Rickert (2011/0295338), Oweiss (2011/0307079), Chung .
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/KELSEY E BALLER/ Examiner, Art Unit 3785
/TU A VO/ Primary Examiner, Art Unit 3785
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