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 § 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.
Claims 1-20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as failing to set forth 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.
Regarding claim 1, the claim recites “a first assessment tool”, “a second assessment tool”, “one or more processors”, and “a display” without disclosing the structural cooperation between the assessment tools and the one or more processors and the display. The claim is incomplete for omitting essential structural cooperative relationships of elements, such omission amounting to a gap between the necessary structural connections (see MPEP § 2172.01). The omitted structural cooperative relationships are: the structural cooperation between the assessment tools and the one or more processors and the display. Further clarification is respectfully requested.
Regarding claim 2, the claim recites the broad limitation “one or more electrical sensors” and the narrower statement of the limitation “one or more acoustic sensors”. A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired (see MPEP § 2173.05(c)). The claim is considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Regarding claim 6, the claim recites that “the second sensor data represents a measured physical value of a swinging motion of the reflex hammer”. On the other hand, the independent claim 1 discloses that “second sensor data” is collected from the second assessment tool, which is not associated with the reflex hammer. The claim does not disclose how the second sensor data associated with the second assessment tool can be configured to represent “a measured physical value of a swinging motion” of the first assessment tool. Further clarification is respectfully requested.
Regarding claim 8, the claim recites that “the second assessment tool includes an intermediate contact portion operable to be placed over an area adjacent the target area, the intermediate contact portion including one or more third sensors operable to measure an impact force of the reflex hammer”. The configuration of “the intermediate contact portion including one or more third sensors” appears to be related to the embodiment where “an intermediate contact portion (e.g., punch or a contact pad) laid over the target area of the subject to be struck by the impact tool” (see paragraph section [0028] of the specification dated 08/29/2024). In this embodiment, the intermediate contact portion is not disclosed to be associated with the second assessment tool including a band. Further clarification is respectfully requested.
Regarding claim 10, the claim recites “a first assessment tool”, “a second assessment tool”, “one or more processors”, and “a display” without disclosing the structural cooperation between the assessment tools and the one or more processors and the display. The claim is incomplete for omitting essential structural cooperative relationships of elements, such omission amounting to a gap between the necessary structural connections (see MPEP § 2172.01). The omitted structural cooperative relationships are: the structural cooperation between the assessment tools and the one or more processors and the display.
Regarding claim 17, the term “light touching” is a relative term which renders the claim indefinite. The term “light” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Further clarification is respectfully requested.
Regarding claim 18, the claim recites “an indication of an objective neurological assessment parameter value calculated based on the first sensor data and the second sensor data” without disclosing the device for performing the calculation and then presenting the indication at the display. The claim is incomplete for omitting essential elements, such omission amounting to a gap between the elements (see MPEP § 2172.01). The omitted elements are: the device for performing the calculation and then presenting the indication at the display. Further clarification is respectfully requested.
Claims 3-5, 7, 9, 11-16, 19-20 are rejected as being dependent on the rejected base claim.
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.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-20 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Freeman et al. (Pat. No. US 12,648,763) (hereafter Freeman).
Regarding claim 1, Freeman teaches a neurological function assessment system comprising:
a first assessment tool being
a reflex hammer (i.e., reflex hammer 100) (see Fig. 1) including a handle (i.e., handle 110) (see Fig. 1), a hammer head (i.e., head 115) (see Fig. 1), and one or more first sensors (i.e., impact force sensors 130 and 135 and head 115 may also include an electronics cavity 140 that substantially rigidly supports one or more inertial measurement units (IMUs) such as gyros or accelerometers 145) (see Fig. 1);
a second assessment tool being a wearable device including:
a band operable to wrap around a body part of a subject (i.e., patient telemetry monitor/device 315) (see Fig. 3), and one or more second sensors disposed on the band operable to sense a target area at the body part (i.e., device 315 may include one or more accelerometers for sensing and generating telemetry data representative of movement of the leg of the patient 305 in response to the smart hammer 100 striking the knee 310) (see Fig. 4); and
one or more non-transitory computer-readable media storing instructions which, when executed by one or more processors (i.e., processors 210 and 510 and monitoring station 330) (see Fig. 2-3 and 5), cause the neurological function assessment system to:
collect first sensor data, from the first assessment tool, corresponding to an assessment event at the first assessment tool (i.e., first acceleration data and force data are received from a first accelerometer and force sensor of the reflex hammer that is used to strike a patient tendon) (see Column 11, line 55, to Column 12, line 19),
collect second sensor data, from the second assessment tool, corresponding to the assessment event (i.e., second acceleration data is received from a second accelerometer coupled to a limb of the patient in response to the strike of the patient tendon at operation 820) (see Column 11, line 55, to Column 12, line 19), and
present, at a display, an indication of an objective neurological assessment parameter value calculated based on the first sensor data and the second sensor data (i.e., collected data is processed at operation 830 to characterize the patient response to the strike. Operation 840 may be performed to display a representation of the characterized patient response, such as by use of an LED or other type of display) (see Column 11, line 55, to Column 12, line 19).
Regarding claim 2, Freeman teaches that the one or more first sensors include one or more electrical sensors (i.e., sensors 145) (see Fig. 1) and one or more acoustic sensors.
Regarding claim 3, Freeman teaches that the first sensor data represents a tissue activation occurring at the target area responsive to the assessment event (i.e., tapping a reflex hammer on the patellar tendon generates neural feedback from the nerves to the spinal cord and back to the muscle to counteract the tendon stretch preventing injury to the muscle and tendon. The smart reflex hammer provides data from the sensors that quantifies several components of the neurological deep tendon reflexes including acceleration and velocity of the hammer, and amplitude of the reflex similar to pendulum action and back) (see Column 4, lines 19-28).
Regarding claim 4, Freeman teaches that the tissue activation includes a muscle activation, a nerve activation, or a tendon activation (i.e., muscle and tendon activation) (see Column 4, lines 19-28).
Regarding claim 5, Freeman teaches that the one or more second sensors include at least one of an accelerometer (i.e., accelerometers 430) (see Fig. 4), a gyroscope, a location sensor, a position sensor, a force sensor, or a motion sensor.
Regarding claim 6, Freeman teaches that the second sensor data represents a measured physical value of a swinging motion of the reflex hammer (i.e., data from device 315 begins in response to the hammer strike at a time delay of response 640. A curve 645 represents acceleration, and hence velocity, of the leg in one example. A peak response time 650 corresponds to the maximum acceleration 652, which then decreases up to a time of response return to zero 655) (see Fig. 6).
Regarding claim 7, Freeman teaches that the assessment event includes a knee jerk reflex test performed with the reflex hammer; and the target area includes an upper leg area of the subject (i.e., knee reflex test) (see Column 4, lines 19-28).
Regarding claim 8, Freeman teaches that the second assessment tool includes an intermediate contact portion operable to be placed over an area adjacent the target area, the intermediate contact portion including one or more third sensors operable to measure an impact force of the reflex hammer (i.e., the bumpers may be supported by the force sensors, or may be sufficiently compliant to consistently transfer force from impacts to the pressure sensor, yet firm enough to trigger sufficient reflex response) (see Fig. 1).
Regarding claim 9, Freeman teaches that the first assessment tool includes one or more electrodes; and the first sensor data includes electrical activity data detected by the one or more electrodes (i.e., impact force sensors 130, 135. Force Sensors detect and respond to the presence or a change in the amount of pressure on an actuator, which can be a ball, button, diaphragm, flat membrane, plunger, or pushbutton. Three example sensor types are force sensing resistor, load cell, and resistive) (see Column 5, lines 1-21).
Regarding claim 10, Freeman teaches a neurological function assessment system comprising:
a first assessment tool (i.e., reflex hammer 100) (see Fig. 1) including one or more first sensors (i.e., impact force sensors 130 and 135 and head 115 may also include an electronics cavity 140 that substantially rigidly supports one or more inertial measurement units (IMUs) such as gyros or accelerometers 145) (see Fig. 1);
a second assessment tool being a wearable device including:
a band operable to wrap around a body part of a subject (i.e., patient telemetry monitor/device 315) (see Fig. 3), and one or more second sensors disposed on the band operable to sense a target area at the body part (i.e., device 315 may include one or more accelerometers for sensing and generating telemetry data representative of movement of the leg of the patient 305 in response to the smart hammer 100 striking the knee 310) (see Fig. 4); and
one or more non-transitory computer-readable media storing instructions which, when executed by one or more processors (i.e., processors 210 and 510 and monitoring station 330) (see Fig. 2-3 and 5), cause the neurological function assessment system to:
collect first sensor data, from the first assessment tool, corresponding to an assessment event including the first assessment tool contacting an area of the subject adjacent the target area (i.e., first acceleration data and force data are received from a first accelerometer and force sensor of the reflex hammer that is used to strike a patient tendon) (see Column 11, line 55, to Column 12, line 19),
collect second sensor data, from the second assessment tool, corresponding to the assessment event (i.e., second acceleration data is received from a second accelerometer coupled to a limb of the patient in response to the strike of the patient tendon at operation 820) (see Column 11, line 55, to Column 12, line 19), and
present, at a display, an indication of an objective neurological assessment parameter value calculated based on the first sensor data and the second sensor data (i.e., collected data is processed at operation 830 to characterize the patient response to the strike. Operation 840 may be performed to display a representation of the characterized patient response, such as by use of an LED or other type of display) (see Column 11, line 55, to Column 12, line 19).
Regarding claim 11, Freeman teaches that the first assessment tool includes a reflex hammer with a handle (i.e., handle 110) (see Fig. 1), a hammer head (i.e., head 115) (see Fig. 1); and the one or more first sensors are formed into the handle or the hammer head, and the one or more first sensors include at least one of an accelerometer, a gyroscope, a location sensor, a position sensor, a force sensor, or a motion sensor (i.e., impact force sensors 130 and 135 and head 115 may also include an electronics cavity 140 that substantially rigidly supports one or more inertial measurement units (IMUs) such as gyros or accelerometers 145) (see Fig. 1).
Regarding claim 12, Freeman teaches that the first assessment tool includes a contact pad, positionable at the target area, and operable to measure an impact force (i.e., each bumper 120, 125 has a corresponding respective embedded impact force sensors 130, 135) (see Column 5, lines 1-21).
Regarding claim 13, Freeman teaches that the one or more second sensors includes a plurality of electrical sensors forming an array on the band of the second assessment tool (i.e., accelerometers 430) (see Fig. 4-5).
Regarding claim 15, Freeman teaches that the instructions, when executed by the one or more processors, cause the neurological function assessment system to collect third sensor data, from the second assessment tool, and responsive to an electric or acoustic stimulus caused by the second assessment tool; and the objective neurological assessment parameter value is calculated based at least partly on the third sensor data (i.e., addition accelerometer 530 may be coupled to the communication bus 520 and may be oriented differently from accelerometer 430. The orientation may be orthogonal in one embodiment to ensure diversity of data in sensing acceleration. Second acceleration data is received from a second accelerometer coupled to a limb of the patient in response to the strike of the patient tendon at operation 820. The collected data is processed at operation 830 to characterize the patient response to the strike) (see Column 8, lines 19-29, and Column 11, line 55, to Column 12, line 19).
Regarding claim 16, Freeman teaches that the objective neurological assessment parameter value is based on at least one of a reflex response value; a motor power response value, or a sensation response value (i.e., tapping a reflex hammer on the patellar tendon generates neural feedback from the nerves to the spinal cord and back to the muscle to counteract the tendon stretch preventing injury to the muscle and tendon. The smart reflex hammer provides data from the sensors that quantifies several components of the neurological deep tendon reflexes including acceleration and velocity of the hammer, and amplitude of the reflex similar to pendulum action and back) (see Column 4, lines 19-28).
Regarding claim 17, Freeman teaches that the first assessment tool includes a swab or a pinprick tool (i.e., bumpers with sensors may be provided with suitable connectors to mate with connectors in the head 115 such that various sized bumpers may be used with the hammer 100) (see Column 6, lines 21-30); and the assessment event includes a light touching with the first assessment tool at the area of the subject adjacent to the target area (i.e., tapping a reflex hammer on the patellar tendon generates neural feedback from the nerves to the spinal cord and back to the muscle to counteract the tendon stretch preventing injury to the muscle and tendon. The smart reflex hammer provides data from the sensors that quantifies several components of the neurological deep tendon reflexes including acceleration and velocity of the hammer, and amplitude of the reflex similar to pendulum action and back) (see Column 4, lines 19-28).
Regarding claim 18, Freeman teaches a method of neurological function assessment, the method comprising:
collecting first sensor data, using a first assessment tool including one or more first sensors, the first sensor data corresponds to the first assessment tool contacting an area adjacent a target area of a subject (i.e., first acceleration data and force data are received from a first accelerometer and force sensor of the reflex hammer that is used to strike a patient tendon) (see Column 11, line 55, to Column 12, line 19);
collecting second sensor data using a second assessment tool being a wearable device including one or more second sensors operable to sense the target area (i.e., second acceleration data is received from a second accelerometer coupled to a limb of the patient in response to the strike of the patient tendon at operation 820) (see Column 11, line 55, to Column 12, line 19); and
present, at a display, an indication of an objective neurological assessment parameter value calculated based on the first sensor data and the second sensor data (i.e., collected data is processed at operation 830 to characterize the patient response to the strike. Operation 840 may be performed to display a representation of the characterized patient response, such as by use of an LED or other type of display) (see Column 11, line 55, to Column 12, line 19).
Regarding claim 19, Freeman teaches calculating, based on the first sensor data, an impact force associated with the first assessment tool contacting the area adjacent to the target area, the objective neurological assessment parameter value is calculated by using the impact force as a normalization factor (i.e., impact force sensors 130, 135 detect and respond to the presence or a change in the amount of pressure on an actuator, which can be a ball, button, diaphragm, flat membrane, plunger, or pushbutton. Three example sensor types are force sensing resistor, load cell, and resistive. Data is generated by the force sensors 130, 135 representative of pounds per square inch (PSI) or pascals on the sensor. Calibration for each hammer may be performed on manufacture to account for manufacturing tolerances by testing each hammer using consistent striking force and surface impacts) (see Column 5, lines 1-21).
Regarding claim 20, Freeman teaches calculating, based on the second sensor data, a tissue activation factor associated with a tissue of the target area, the objective neurological assessment parameter value is calculated based on the tissue activation factor (i.e., data collected may be used at a minimum, to determine a difference in time between impact and delay of response, which can be correlated to one or more patient conditions, including normal responses. Other data, such as the response peak and impact force to response velocity difference, indicated at 670 may be correlated to other patient conditions. The response decay curve 652 and oscillations of the response curve 645 may be correlated to further patient conditions. These correlations may be made via conducting tests and correlating resulting data to known patient conditions) (see Column 9, line 45, to Column 11, line 41).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: pto-892.
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/Tran M. Tran/Examiner, Art Unit 2855
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