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 § 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 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 1-8, 10-13, 15, 17-20, 22, 24 and 28 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Salisbury et al. (US 2024/0009057; hereinafter “Salisbury”).
Regarding claim 1, Salisbury teaches a method of testing a muscle or a muscle group for muscle stiffness or spasticity, the method comprising: controlling an actuator to periodically change between a pressurized state and a relaxed state (e.g. ¶¶ 24, 81, etc. – “piezoelectric actuator” where the examiner considers the step of deforming “so as to deliver a mechanical stimulus to a muscle” to be the pressurized state) such that the actuator in at least the pressurized state provides a cyclic force contributing to at least one deformation of a piezoelectric film (e.g. ¶¶ 81-83), the actuator in at least the relaxed state providing a lateral surface in abutment with the piezoelectric film (e.g. ¶¶ 17 – “shaped to indent”), the piezoelectric film being variably deformable and conformable to the muscle or the muscle group (e.g. ¶¶ 83-84 – “To be effective in providing a stimulus to the muscle afferents of a wearer, rather than simply to the surface of the wearer's skin, the stimulation device 10 is shaped to indent the flesh of a wearer's limb”); acquiring a signal generated by the at least one deformation of the piezoelectric film, wherein a change in the signal corresponds to the at least one deformation of the piezoelectric film; and determining a quantitative measure of a muscle spasticity state of the muscle or the muscle group based on the signal (e.g. ¶¶ 113, 152-153 – “deform by up to 2 mm, for example between 1 mm and 2 mm when a charge is applied, which may result in a force of between 6 and 10N being transmitted to the casing of the device”).
Regarding claim 20, Salisbury discloses a device for testing a muscle or a muscle group for muscle stiffness or spasticity in accordance with the method as recited in claim 1, the device comprising: a piezoelectric film (e.g. ¶¶ 89 – piezoelectric layer); and an actuator (e.g. ¶¶ 24, 81, etc. – “piezoelectric actuator”), the actuator in at least a relaxed state having a lateral surface in abutment with the piezoelectric film (e.g. ¶¶ 17 – “shaped to indent”), the actuator being operable to periodically change between a pressurized state and the relaxed state (e.g. ¶¶ 24, 81, etc. – where the examiner considers the step of deforming “so as to deliver a mechanical stimulus to a muscle” to be the pressurized state) such that the actuator in at least the pressurized state provides a cyclic force contributing to at least one deformation of the piezoelectric film (e.g. ¶¶ 81-83), the piezoelectric film being variably deformable and conformable to the muscle or the muscle group, wherein the at least one deformation of the piezoelectric film is configured to generate a signal, and wherein a change in the signal corresponds to the at least one deformation of the piezoelectric film (e.g. ¶¶ 113, 152-153 – “deform by up to 2 mm, for example between 1 mm and 2 mm when a charge is applied, which may result in a force of between 6 and 10N being transmitted to the casing of the device”).
Regarding claim 28, Salisbury discloses a system for performing the method of testing a muscle or a muscle group for muscle stiffness or spasticity as recited in claim 1,the system comprising: a wearable article; a piezoelectric film; an actuator, the actuator including a lateral surface, the actuator being attachable to the wearable article with the piezoelectric film is disposed between the lateral surface of the actuator and the muscle or the muscle group the actuator being configured to enable the piezoelectric film to be variably deformable and conformable to the muscle or the muscle group (e.g. Fig. 6); a controller; and a fluid source, the fluid source being coupled to the controller, the controller being configured to open or close a fluid communication between the fluid source and the actuator to periodically changed the actuator between a the pressurized state and the relaxed state (e.g. ¶¶ 204-205) wherein the controller is configured to: control the actuator to periodically change between the pressurized state and the relaxed state, the actuator in at least the pressurized state providing a cyclic force contributing to at least one deformation of the piezoelectric film, the actuator in at least the relaxed state having the lateral surface in abutment with the piezoelectric film (e.g. ¶¶ 81-86); acquire a signal generated by the at least one deformation of the piezoelectric film, a change in the signal corresponding to the at least one deformation of the piezoelectric film; and determine a quantitative measure of a muscle spasticity state of the muscle or the muscle group based on the signal (e.g. ¶¶ 113, 152-153 – “deform by up to 2 mm, for example between 1 mm and 2 mm when a charge is applied, which may result in a force of between 6 and 10N being transmitted to the casing of the device”).
Regarding claim 2, Salisbury teaches the piezoelectric film is conformable to both the actuator in the pressurized state and to the muscle or the muscle group (e.g. ¶¶ 83-86).
Regarding claim 3, Salisbury teaches the piezoelectric film is flexible, and wherein the piezoelectric film is variably deformable in response to a stiffness of the muscle or the muscle group (e.g. ¶¶ 176).
Regarding claim 4, Salisbury teaches the piezoelectric film is held in a test position independently of the cyclic force, the test position being between the lateral surface and the muscle or the muscle group (e.g. ¶¶ 128-130, etc.).
Regarding claim 5, Salisbury teaches controlling a fluid communication between a fluid source and an elastic bag of the actuator, wherein the lateral surface is part of the elastic bag, and wherein the actuator is in the pressurized state if the elastic bag is inflated by the fluid source, wherein the actuator is in the relaxed state if the elastic bag is at least partially deflated (e.g. ¶¶ 205).
Regarding claim 6, Salisbury teaches the signal is a time series voltage signal comprising at least one local peak corresponding to the pressurized state (e.g. ¶¶ 144-146, etc.).
Regarding claim 7, Salisbury teaches a mean amplitude of the at least one local peak corresponds to a degree of severity of a muscle spasticity state (e.g. ¶¶ 44, 129).
Regarding claim 8, Salisbury teaches the signal acquired when the muscle or the muscle group is in one of an isometric contraction and a static state (e.g. ¶¶ 84).
Regarding claim 10, Salisbury teaches the signal includes at least one first local peak if the muscle or the muscle group is in a flexion state, and wherein the signal includes at least one second local peak if the muscle or the muscle group is in an extended state (e.g. ¶¶ 176-179).
Regarding claim 11, Salisbury teaches the muscle spasticity state based on a ratio between the at least one first local peak and the at least one second local peak (e.g. ¶¶ 144-146).
Regarding claim 13, Salisbury teaches determining the muscle spasticity state based on a difference between the at least one first local peak and the at least one second local peak (e.g. ¶¶ 144-146).
Regarding claim 15, Salisbury teaches periodically switching the actuator between the pressurized state and the relaxed state; and concurrently acquiring the signal from the piezoelectric film when the muscle is in a transition state, the transition state being characterized by a dynamic motion of the muscle or the muscle group between a flexion state of the muscle and an extended state of the muscle (e.g. ¶¶ 83-86).
Regarding claim 17, Salisbury teaches the signal comprises a time series of peaks, the signal including at least one first local peak corresponding to the flexion state, at least one second local peak corresponding to the extended state, and at least one third local peak corresponding to the transition state (e.g. ¶¶ 128-130).
Regarding claim 18, Salisbury teaches the at least one third local peak is characterized by a smaller voltage value than each of the at least one first local peak and the at least one second local peak (e.g. ¶¶ 144-146).
Regarding claim 19, Salisbury teaches a difference between the at least one third local peak and the at least one first local peak corresponds to a muscle spasticity state (e.g. ¶¶ 44, 129).
Regarding claim 22, Salisbury teaches the piezoelectric film is flexible and wherein the piezoelectric film is variably deformable in response to a stiffness of the muscle or the muscle group and wherein the piezoelectric film is configured to provide a first signal representative of a first curvature change of the piezoelectric film when the muscle is in flexion and a second signal representative of a second curvature change of the piezoelectric film when the muscle is in extension (e.g. ¶¶ 144-146, etc.).
Regarding claim 24, Salisbury teaches a wearable article, wherein the piezoelectric film is held by the wearable article in a test position independently of the cyclic force (e.g. Fig. 6), the test position being between the lateral surface and the muscle or the muscle group, and wherein the piezoelectric film has a higher tension stiffness along a neutral plane of the piezoelectric film, and wherein the piezoelectric film has a lower bending stiffness about a bending axis in the neutral plane of the piezoelectric film (e.g. ¶¶ 144-146, etc.).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Michael D’Abreu whose telephone number is (571) 270-3816. The examiner can normally be reached on 7AM-4PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David Hamaoui can be reached at (571) 270-5625. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHAEL J D'ABREU/Primary Examiner, Art Unit 3796