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 .
Status of Claims
The present Office action is responsive to the Request for Continued Examination filed on 04-27-2026. As directed, claims 1, 3-6, 7, 10, 18, and 20 have been amended, claim 9 was previously canceled, no claims have been newly canceled in the present reply, and no new claims have been added. Thus, claims 1-8 and 10-20 are currently pending examination.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 04-27-2026 has been entered.
Response to Amendment
Applicant has amended each of claims 1, 3-5, 7, 10, 15, 18, and 20 to address minor informalities within these claims. The previously held claim objections are hereby withdrawn.
Response to Arguments
Applicant argues, see Remarks as filed page 7, that the relied upon combination of Pamukoff, Pisharodi, and Yu fail to disclose the newly amended language of claims 1 and 20. In particular, it is argued that none of the references teach use of the claimed device by an individual with an ACL injury, which produces change in the length of the quadriceps and excites the quadriceps via the muscle spindle system, thus restoring native function of the knee. Applicant alleges that this is because Pamukoff only studied healthy individuals, free from knee injury or dysfunction, and does not discuss stimulating the quadriceps. Applciant also alleges that both Yu and Pisharodi, as relied upon, are relied on for functions other than restoring native function of the quadriceps following knee injury (i.e. pain management), and thus combination of Pamukoff with Yu and/or Pisharodi is not obvious.
However, upon further examination of Pamukoff, it is believed that Pamukoff either anticipates or renders obvious the additionally claimed portions of claim 1 and 20. First, the claims now require wherein the treatment surface of the subject is an area of the subject's thigh proximal to a quadriceps muscle of the subject. Such a placement of the Pamukoff device is explicitly shown in the bottom tiles of Figure 1, where the stimulator is placed over the knee, and overlaps with the thigh in the area of the quadriceps at the anterior thigh. Further, the description under Figure 1 explicitly states “The under surface of the frame was curved to accommodate the shape of the anterior thigh” and the disclosure additionally provides “A custom-built LMV device was secured over the quadriceps tendon” (see pg. 889, second column, first two lines under the heading “2.5 Local muscle vibration intervention”).
Further, the claims now require an electromagnetic electromagnetic oscillator “for applying vibratory stimulus to the quadriceps muscle, producing changes in length of the quadriceps muscle and exciting the quadriceps muscle via a muscle spindle system of the quadriceps muscle, for restoring native function of the quadriceps muscle following knee injury or disease of the knee”. Pamukoff also contemplates these limitations. First, as noted above, the Pamukoff device, including the claimed electromagnetic oscillator, is placed over the knee, and overlaps with the thigh in the area of the quadriceps at the anterior thigh. Further, the description under Figure 1 explicitly states “The under surface of the frame was curved to accommodate the shape of the anterior thigh” and the disclosure additionally provides “A custom-built LMV device was secured over the quadriceps tendon” (see pg. 889, second column, first two lines under the heading “2.5 Local muscle vibration intervention”). Additionally, the conclusion clearly states “Our findings suggest that 30 Hz LMV treatment acutely enhances EMG activity in the quadriceps muscles” (see pg. 893, first two lines under the heading “5. Conclusion”). Thus, it is established that Pamukoff contemplates the stimulation of the quadriceps muscle. Further though, Pamukoff establishes that vibration is known to produce changes in length of the muscle and exciting the muscle via a muscle spindle system of the muscle (see pg. 888, first two sentences under the heading “1. Introduction”; note that vibration stimuli is noted to stimulate muscle spindles, and cause tonic vibratory reflex, which is a type of muscle contraction, where contraction changes the length of the muscle). Finally, Pamukoff also posits that “Our data indicate increased EMG activity persists for 5 min following LMV, which is consistent with prior studies (Bazett-Jones et al., 2008; McBride et al., 2010). This is a clinically relevant finding since vibration could be used prior to strengthening exercises in patients with deficits in voluntary quadriceps activation. For example, patients with knee osteoarthritis and ACL injury have impaired voluntary quadriceps activation (Hart et al., 2010; Pietrosimone et al., 2011), which limits the efficacy of rehabilitation (Hopkins and Ingersoll, 2000; Hurley et al., 1994)” (see pg. 892, first column, final paragraph), and further concludes “These findings suggest that LMV may be useful as an adjunct to traditional exercise to elicit improvements in neuromuscular function” (see pg. 893, lines 4-6 under the heading “5. Conclusion”). Thus, Pamukoff explicitly provides the ordinarily skilled artisan with a disclosure that patients with knee injuries could be treated with local muscle vibration in order to activate the quadriceps as a part of a rehabilitation effort to restore/improve function thereto.
For these reasons, Applicant’s arguments are unpersuasive, and the previously applied combination of Pamukoff, Pisharodi, and Yu will be updated to address the newly amended language, and maintained hereinbelow.
Claim Objections
Claims 1, 5, and 20 are objected to because of the following informalities:
At claim 1, line 7, it is suggested that “configured for” be added prior to “producing” to more explicitly avoid claiming the human organism.
At claim 1, line 8, it is suggested that “configured for” be added prior to “exciting” to more explicitly avoid claiming the human organism.
At claim 1, line 9, it is suggested that “knee injury” be replaced with “injury to a knee” for proper antecedent basis.
At claim 1, line 12, it is suggested that “causes” be replaced with “configured to cause” to avoid recitation of positive method steps in a device claim.
At claim 5, line 2, it is suggested that “the” be added before “vibratory stimulus” for clarity.
At claim 20, line 6, it is suggested that “knee injury” be replaced with “injury to a knee” for proper antecedent basis.
At claim 20, line 6, it is suggested that “electromagnetic” be added before “electromagnetic oscillator” for consistency throughout the remainder of the claim.
At claim 20, line 7, it is suggested that “the” be added before “vibratory stimulus” for clarity.
At claim 20, lines 8-9, it is suggested that “a quadriceps muscle” be replaced with “the quadriceps muscle” as the limitation was introduced in line 4.
At claim 20, line 12, it is suggested that “the” be added before “vibratory stimulus” for clarity.
At claim 20, line 13, it is suggested that “thereby” be added before “producing” for clarity.
Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
As such, the “means for securing” in claim 1 is being interpreted relative to claim 8 and the instant specification to refer to a strap, and the “means for securing” in claim 17 is being interpreted relative to the instant specification at Figure 1A to include a strap.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or non-obviousness.
Claims 1, 5, 8, 10-11, 15, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Pamukoff et al. “The acute effects of local muscle vibration frequency on peak torque, rate of torque development, and EMG activity” as cited on the IDS submitted on 09-23-2022 and hereinafter referred to as Pamukoff, in view of Yu (US 10,589,116) and Pisharodi (US 2017/0348184).
Regarding claim 1, Pamukoff discloses a wearable local muscle vibratory stimulator (page 889, section 2.5; Fig. 1 and its appended description, noting the LMV device worn on the subject in the bottom right image) comprising:
a frame including a concave surface for conforming to a treatment surface of a subject, wherein the treatment surface of the subject is an area of the subject’s thigh proximal to a quadriceps muscle of the subject (Fig. 1, and its appended description, which notes “the LMV stimulator consisted of a single-axis electromagnetic oscillator mounted on a plastic frame. The under surface of the frame was curved to accommodate the shape of the anterior thigh”; see pg. 889, second column, first two lines under the heading “2.5 Local muscle vibration intervention”, which refers to the device being secured over the quadriceps tendon);
an electromagnetic oscillator located in the frame for applying vibratory stimulus to the quadriceps muscle, producing changes in length of the quadriceps muscle and exciting the quadriceps muscle via a muscle spindle system of the quadriceps muscle, for restoring native function of the quadriceps muscle following knee injury or disease of the knee (Fig. 1, and its appended description, which notes “the LMV stimulator consisted of a single-axis electromagnetic oscillator mounted on a plastic frame”, page 889, section 2.5 further outlines treatment of the muscles and tendons underneath the skin of the applied region; see pg. 893, first two lines under the heading “5. Conclusion”, where stimulation of the quadriceps is detailed; see pg. 888, first two sentences under the heading “1. Introduction”; note that vibration stimuli is noted to stimulate muscle spindles, and cause tonic vibratory reflex, which is a type of muscle contraction, where contraction changes the length of the muscle; see pg. 892, first column, final paragraph, which outlines that restoration/improvement of muscle function can be achieved using LMV for patients with ACL injury or osteoarthritis; see also pg. 893, lines 4-6 under the heading “5. Conclusion”);
an accelerometer coupled to the electromagnetic oscillator for measuring frequency and acceleration of oscillation of the electromagnetic oscillator (Fig. 1, and its appended description, which notes “the LMV stimulator consisted of a single-axis electromagnetic oscillator mounted on a plastic frame” and “the acceleration was constrained to 2g via feedback provided to the controller from an accelerometer”);
a controller coupled to the electromagnetic oscillator and the accelerometer for receiving measurements of frequency and acceleration of oscillation of the electromagnetic oscillator from the accelerometer and controlling the frequency and acceleration of oscillation of the electromagnetic oscillator to minimize a difference between the desired frequency and acceleration of oscillation of the electromagnetic oscillator and the frequency and acceleration of oscillation measured by the accelerometer (Fig. 1, and its appended description, which notes “the LMV stimulator consisted of a single-axis electromagnetic oscillator mounted on a plastic frame” and “the acceleration was constrained to 2g via feedback provided to the controller from an accelerometer”); and
means for securing the frame to the subject’s thigh so that the electromagnetic oscillator is wearable and positioned to deliver the vibratory stimulus to the quadriceps muscle of the subject for restoring native function of the quadriceps muscle following the knee injury or disease of the knee (see Fig. 1, where the LMV is mounted to the subject’s knee via a series of straps, and in particular to the anterior thigh; see pg. 893, first two lines under the heading “5. Conclusion”, where stimulation of the quadriceps is detailed; see pg. 888, first two sentences under the heading “1. Introduction”; note that vibration stimuli is noted to stimulate muscle spindles, and cause tonic vibratory reflex, which is a type of muscle contraction, where contraction changes the length of the muscle; see pg. 892, first column, final paragraph, which outlines that restoration/improvement of muscle function can be achieved using LMV for patients with ACL injury or osteoarthritis; see also pg. 893, lines 4-6 under the heading “5. Conclusion”).
Pamukoff fails to explicitly disclose:
a waveform generator coupled to the electromagnetic oscillator for generating an electrical signal that causes the electromagnetic oscillator to oscillate; and
a controller user interface for receiving user input regarding a desired frequency and acceleration of oscillation of the electromagnetic oscillator, wherein the controller user interface comprises a graphical user interface including a first graphical tool for selecting one a plurality of different frequencies for controlling the frequency of the oscillation of the electromagnetic oscillator and a second graphical tool for selecting one of a plurality of different force values for controlling the acceleration of the oscillation.
However, Yu teaches a wearable pain management system (10) (Col. 4, lines 24-25; Fig. 1) which includes an electromagnetic oscillator (95) and a waveform generator (91) coupled to the electromagnetic oscillator (95) for generating an electrical signal that causes the electromagnetic oscillator (95) to oscillate by sending a particular commanded waveform in order to improve intercellular fluid and blood flow, stimulate electron transport, and stimulate the release of endorphins to mask pain (Col. 4, lines 63-66; Col. 5, lines 1-4; Fig. 5); and
a controller user interface for receiving user input regarding a desired frequency and acceleration of oscillation of the electromagnetic oscillator (Col. 5, lines 36-41, where the external device, i.e, smart phone, is the controller user interface).
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 electromagnetic oscillator of Pamukoff to have included a waveform generator in communication with the electromagnetic oscillator in order to direct and command particular electromagnetic oscillatory waveforms to the electromagnetic oscillator as desired, as taught by Yu, in order to achieve various health outcomes such as improvement of intercellular fluid and blood flow, stimulation of electron transport, and stimulation of the release of endorphins to mask pain, and as a known method of producing oscillation of the electromagnetic oscillator.
It would have been further obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the LMV device of Pamukoff to include a controller user interface for receiving user input regarding a desired frequency and acceleration of oscillation of the electromagnetic oscillator, as further taught by Yu, in order to enable a user to control the operation of the waveform generator, and thus the electromagnetic oscillator.
The device of now modified Pamukoff fails to disclose wherein the controller user interface comprises a graphical user interface including a first graphical tool for selecting one a plurality of different frequencies for controlling the frequency of the oscillation of the electromagnetic oscillator and a second graphical tool for selecting one of a plurality of different force values for controlling the acceleration of the oscillation.
However, Pisharodi teaches a controller user interface (610B) with a graphical user interface (720) for controlling the device (600) which includes a first graphical tool for selecting one of a plurality of different frequencies for controlling the frequency of oscillation and a second graphical tool for selecting one of a plurality of different force values for controlling the acceleration of the oscillation (paragraph 42, lines 1-11; paragraph 48, lines 1-23, see in particular the variables ZV and fV, which are respectively defined as amplitude and frequency at paragraph 36, lines 3-6; further, note paragraph 35, lines 13-18 and Fig. 4A, where the amplitude is defined as a force in the Z-axis, where force and acceleration are related through Newton’s second law; at paragraph 48, lines 9-20, note the use of vibration intensity selection button 730, and each of the up and down arrows 755 for setting frequency and amplitude, where at least the respective up and down arrows read on the first and second graphical tools; Fig. 7).
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 controller user interface of modified Pamukoff to further include a graphical user interface including a first graphical tool for selecting one a plurality of different frequencies for controlling the frequency of the oscillation of the electromagnetic oscillator and a second graphical tool for selecting one of a plurality of different force values for controlling the acceleration of the oscillation, as taught by Pisharodi, in order to visually ascertain the settings of the device, and allow the user to manipulate the frequency and force values for the actuator.
Regarding claim 5, Pamukoff in view of Yu and Pisharodi disclose the stimulator of claim 1, as discussed above.
Pamukoff further discloses wherein the electromagnetic oscillator comprises a single-axis electromagnetic oscillator for applying vibratory stimulus to the treatment surface along a single axis (Fig. 1, and its appended description, which notes “the LMV stimulator consisted of a single-axis electromagnetic oscillator mounted on a plastic frame” and note LMV stands for “local muscle vibration”).
Regarding claim 8, Pamukoff in view of Yu and Pisharodi disclose the stimulator of claim 1, as discussed above.
Pamukoff further discloses wherein the means for holding includes at least one strap (see Fig. 1, where the LMV is mounted to the subject’s knee via a series of straps).
Pamukoff does not explicitly disclose or illustrate that the frame includes strap guides located at opposite ends of the concave surface.
However, Yu further teaches strap guides (see Fig. 1, where bottom surface 22 includes vertically oriented guides into which the belt body 45 is inserted) on opposite ends of a frame (20) (Fig. 1).
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 frame of Pamukoff to includes strap guides on opposite ends of the bottom concave surface, as further taught by Yu, in order to secure the straps to the frame and facilitate attachment of the frame to the user’s body.
Regarding claim 10, Pamukoff in view of Yu and Pisharodi disclose the stimulator of claim 9, as discussed above.
Modified Pamukoff further discloses wherein the graphical user interface is displayable on a mobile device (Yu: Col. 5, lines 34-41 and Pisharodi: paragraph 47, lines 1-8) and wherein the stimulator (Pamukoff: electromagnetic stimulator) further comprises a user control communication interface (Yu: 90) for receiving control input from the user via the graphical user interface and for communicating the control input to the controller (Pamukoff: controller) (Yu: Col. 5, lines 36-41, and note the use of Bluetooth in Pisharodi’s paragraph 47).
Regarding claim 11, Pamukoff in view of Yu and Pisharodi disclose the stimulator of claim 10, as discussed above.
Modified Pamukoff further discloses wherein the user control communication interface (Yu: 90) comprises a wireless communication interface (Yu: Col. 5, lines 36-41, see “wireless”; see also “Bluetooth” in Pisharodi’s paragraph 47).
Regarding claim 15, Pamukoff in view of Yu and Pisharodi disclose the stimulator of claim 1, as discussed above.
Modified Pamukoff further discloses an amplifier coupled to the waveform generator, the controller, and the electromagnetic oscillator for controlling the acceleration of oscillations of the electromagnetic oscillator (Fig. 1, and its appended description, which notes “The device was coupled with an amplifier causing it to vibrate in the anterior-posterior direction”, and given that the modified device includes the electromagnetic oscillator and controller of Pamukoff and the waveform generator of Yu, and Pamukoff describes that the amplifier is coupled to the overall device, Examiner interprets the amplifier to be in communication with each of the elements of the device by virtue of its described coupling with the device, and its described function of causing the vibration).
Regarding claim 20, Pamukoff discloses a method for applying vibratory stimulus to a subject during physical rehabilitation or exercise (page 889, section 2.5; Fig. 1 and its appended description, noting the LMV device worn on the subject in the bottom right image, and that the subject is instructed to squat, where a squat is an exercise), the method comprising:
attaching a wearable local muscle vibratory stimulator to the subject’s thigh and positioned to deliver the vibratory stimulus to a quadriceps muscle of the subject for restoring native function of the quadriceps muscle following knee injury or disease of the knee (see Fig. 1, and its appended description where the LMV is mounted to the subject’s knee via a series of straps, and in particular to the anterior thigh; see pg. 893, first two lines under the heading “5. Conclusion”, where stimulation of the quadriceps is detailed; see pg. 888, first two sentences under the heading “1. Introduction”; note that vibration stimuli is noted to stimulate muscle spindles, and cause tonic vibratory reflex, which is a type of muscle contraction, where contraction changes the length of the muscle; see pg. 892, first column, final paragraph, which outlines that restoration/improvement of muscle function can be achieved using LMV for patients with ACL injury or osteoarthritis; see also pg. 893, lines 4-6 under the heading “5. Conclusion”), the wearable vibratory stimulator including an electromagnetic oscillator for oscillating with a frequency and acceleration to deliver vibratory stimulus to a treatment region of the subject, wherein the treatment region includes a quadriceps muscle of the subject (Fig. 1, and its appended description, which notes “the LMV stimulator consisted of a single-axis electromagnetic oscillator mounted on a plastic frame”; see pg. 889, second column, first two lines under the heading “2.5 Local muscle vibration intervention”, which refers to the device being secured over the quadriceps tendon);
while the subject is performing physical rehabilitation or exercise wearing the vibratory stimulator, causing the electromagnetic oscillator to oscillate and deliver vibratory stimulus to the quadriceps muscle, producing changes in length of the quadriceps muscle and exciting the quadriceps muscle via a muscle spindle system of the quadriceps muscle, for restoring native function of the quadriceps muscle following knee injury or disease of the knee (Fig. 1, and its appended description, which notes “the LMV stimulator consisted of a single-axis electromagnetic oscillator mounted on a plastic frame”, page 889, section 2.5 further outlines treatment of the muscles and tendons underneath the skin of the applied region; see pg. 893, first two lines under the heading “5. Conclusion”, where stimulation of the quadriceps is detailed; see pg. 888, first two sentences under the heading “1. Introduction”; note that vibration stimuli is noted to stimulate muscle spindles, and cause tonic vibratory reflex, which is a type of muscle contraction, where contraction changes the length of the muscle; see pg. 892, first column, final paragraph, which outlines that restoration/improvement of muscle function can be achieved using LMV for patients with ACL injury or osteoarthritis; see also pg. 893, lines 4-6 under the heading “5. Conclusion”);
measuring, using an accelerometer, the frequency and acceleration of oscillation of the electromagnetic oscillator (Fig. 1, and its appended description, which notes “the LMV stimulator consisted of a single-axis electromagnetic oscillator mounted on a plastic frame” and “the acceleration was constrained to 2g via feedback provided to the controller from an accelerometer”);
controlling, using a controller, the frequency and acceleration of oscillation of the electromagnetic oscillator to minimize a difference between the desired frequency and acceleration of oscillation of the electromagnetic oscillator and the frequency and acceleration of oscillation measured by the accelerometer (Fig. 1, and its appended description, which notes “the LMV stimulator consisted of a single-axis electromagnetic oscillator mounted on a plastic frame” and “the acceleration was constrained to 2g via feedback provided to the controller from an accelerometer”).
Pamukoff fails to explicitly disclose:
receiving, from a controller user interface, user input regarding a desired frequency and acceleration of oscillation of the electromagnetic oscillator, wherein the controller user interface comprises a graphical user interface including a first graphical tool for selecting one a plurality of different frequencies for controlling the frequency of the oscillation of the electromagnetic oscillator and a second graphical tool for selecting one of a plurality of different force values for controlling the acceleration of the oscillation.
However, Yu teaches a wearable pain management system (10) (Col. 4, lines 24-25; Fig. 1) which includes an electromagnetic oscillator (95) and a waveform generator (91) coupled to the electromagnetic oscillator (95) for generating an electrical signal that causes the electromagnetic oscillator (95) to oscillate by sending a particular commanded waveform in order to improve intercellular fluid and blood flow, stimulate electron transport, and stimulate the release of endorphins to mask pain (Col. 4, lines 63-66; Col. 5, lines 1-4; Fig. 5), wherein a controller user interface for receiving user input regarding a desired frequency and acceleration of oscillation of the electromagnetic oscillator is used to issue control commands to the electromagnetic oscillator (95) (Col. 5, lines 36-41, where the external device, i.e, smart phone, is the controller user interface).
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 device and method of Pamukoff to include a controller user interface for receiving user input regarding a desired frequency and acceleration of oscillation of the electromagnetic oscillator, as taught by Yu, in order to enable a user to control the operation of the waveform generator, and thus the electromagnetic oscillator.
The device and method of now modified Pamukoff fails to disclose wherein the controller user interface comprises a graphical user interface including a first graphical tool for selecting one a plurality of different frequencies for controlling the frequency of the oscillation of the electromagnetic oscillator and a second graphical tool for selecting one of a plurality of different force values for controlling the acceleration of the oscillation.
However, Pisharodi teaches a controller user interface (610B) with a graphical user interface (720) for controlling the device (600) which includes a first graphical tool for selecting one of a plurality of different frequencies for controlling the frequency of oscillation and a second graphical tool for selecting one of a plurality of different force values for controlling the acceleration of the oscillation (paragraph 42, lines 1-11; paragraph 48, lines 1-23, see in particular the variables ZV and fV, which are respectively defined as amplitude and frequency at paragraph 36, lines 3-6; further, note paragraph 35, lines 13-18 and Fig. 4A, where the amplitude is defined as a force in the Z-axis, where force and acceleration are related through Newton’s second law; at paragraph 48, lines 9-20, note the use of vibration intensity selection button 730, and each of the up and down arrows 755 for setting frequency and amplitude, where at least the respective up and down arrows read on the first and second graphical tools; Fig. 7).
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 controller user interface of modified Pamukoff to further include a graphical user interface including a first graphical tool for selecting one a plurality of different frequencies for controlling the frequency of the oscillation of the electromagnetic oscillator and a second graphical tool for selecting one of a plurality of different force values for controlling the acceleration of the oscillation, as taught by Pisharodi, in order to visually ascertain the settings of the device, and allow the user to manipulate the frequency and force values for the actuator.
Claims 2, 6-7, 16, and 18-19 are rejected under 35 U.S.C. 103 as being unpatentable over Pamukoff in view of Yu (US 10,589,116) and Pisharodi (US 2017/0348184), as applied to claim 1 above, in further view of Rahman (US 2018/0085283).
Regarding claim 2, Pamukoff in view of Yu and Pisharodi disclose the stimulator of claim 1, as discussed above.
Modified Pamukoff fails to explicitly disclose wherein the frame includes an electromagnetic oscillator holder and an accelerometer holder.
However, Rahman teaches a sensory output device (10) (paragraph 14, lines 1-8; Fig. 1) which includes a frame (comprisal of 110A and 110B) wherein the frame (comprisal of 110A and 110B) includes an electromagnetic oscillator holder (see the opening in substrate 170 for output device 120) and a sensor holder (170), as a method of arranging the internal device components (paragraph 16, lines 1-10; paragraph 32, lines 1-10; Fig. 1, where 120 is seated in the opening in 170, and sensor 140 is held on substrate 170 within the housing 110; paragraph 34, lines 1-8).
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 frame of Pamukoff to include an electromagnetic oscillator holder and an accelerometer (i.e. a sensor) holder, arranged in the manner as taught by Rahman, as a known arrangement of protectively housing the internal device components in a sensory output device.
Regarding claim 6, Pamukoff in view of Yu, Pisharodi, and Rahman disclose the stimulator of claim 2, as discussed above.
Modified Pamukoff further discloses wherein the accelerometer (see Fig. 1’s appended description in Pamukoff for the accelerometer, and position of sensor 140 in Rahman, taken as analogous to the accelerometer for purposes of modification) is located on an outer edge of the electromagnetic oscillator holder (Rahman: opening in 170) (see Rahman at Fig. 1, where 140 is at the edge of the opening of the aperture for the analogous electromagnetic oscillator 120).
Regarding claim 7, Pamukoff in view of Yu, Pisharodi, and Rahman disclose the stimulator of claim 2, as discussed above.
Modified Pamukoff further discloses wherein the accelerometer (see Fig. 1’s appended description in Pamukoff for the accelerometer, and position of sensor 140 in Rahman, taken as analogous to the accelerometer for purposes of modification) is located at or near a center of the electromagnetic oscillator holder (Rahman: opening in 170) adjacent to a center of the electromagnetic oscillator (see Fig. 1’s appended description in Pamukoff for the electromagnetic electromagnetic oscillator) (Rahman: opening in 170) (see Rahman at Fig. 1, where taking an axis that cuts through the center of 140, sensor 140 is at a center of the opening of the aperture for the analogous electromagnetic oscillator 120, and thus at a center of the analogous electromagnetic oscillator 120).
Regarding claim 16, Pamukoff in view of Yu and Pisharodi disclose the stimulator of claim 1, as discussed above.
Modified Pamukoff fails to disclose a controller printed circuit board, wherein the controller and the waveform generator are located on the printed circuit board.
However, Rahman teaches a controller printed circuit board (170) (paragraph 32, lines 1-11; Fig. 1), wherein all of the electronic components, including the controller (130), sensors (140) communication modules (150), and the power module (160) are located on the printed circuit board in order to facilitate electrical communication and conduction between components thereon (paragraph 32, lines 1-11; note paragraph 33 indicates that additional components can be placed on 170, and note that paragraph 24 describes that 130 an be a controller).
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 device of modified Pamukoff to have provided a controller printed circuit board onto which all of the electronic components were situated, as taught by Rahman, as a known method of electrically connecting the electronic components within a treatment device.
Regarding claim 18, Pamukoff in view of Yu, Pisharodi, and Rahman disclose the stimulator of claim 16, as discussed above.
Presently modified Pamukoff fails to disclose wherein the controller printed circuit board is attached to or integrated within the frame.
However, Rahman further teaches wherein the controller printed circuit board (170) is attached to or integrated within the frame (110) (paragraph 35, lines 1-2).
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 controller printed circuit board of modified Pamukoff to have integrated the controller printed circuit board with the frame, as taught by Rahman, as a known method of constructing a treatment device.
Regarding claim 19, Pamukoff in view of Yu, Pisharodi, and Rahman disclose the stimulator of claim 2, as discussed above.
Modified Pamukoff further discloses wherein the accelerometer holder (Rahman: 170) includes a central aperture for allowing passage of a connector for connecting to the accelerometer (Rahman: Fig. 1, note the opening where the electromagnetic oscillator will be fit in 170, and given that the aperture is described as functionally allowing passage of a connector, the limitation is deemed to be met since the aperture could reasonably function to pass a connector to the accelerometer therethrough; further note that paragraph 34, lines 1-8 indicate an electrical connection between 120 and 170).
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Pamukoff in view of Yu (US 10,589,116), Pisharodi (US 2017/0348184), and Rahman (US 2018/0085283), as applied to claim 2 above, in further view of Ehrenreich (US 2013/0102937).
Regarding claim 3, Pamukoff in view of Yu, Pisharodi, and Rahman disclose the stimulator of claim 2, as discussed above.
Modified Pamukoff further discloses wherein the electromagnetic oscillator holder (Rahman: see aperture in 170 for electromagnetic oscillator 120) includes a central recess for holding the electromagnetic oscillator (Rahman: see Fig. 1 where 170 includes a central aperture for the analogous electromagnetic oscillator 120).
Modified Pamukoff fails to disclose wherein the electromagnetic oscillator comprises a speaker.
However, Ehrenreich teaches an electromagnetic oscillator configured as a speaker to vibrate the treatment device (paragraph 167, lines 1-9, and note that the frequencies described in paragraph 168 all fall within the EM spectrum).
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 substituted the electromagnetic oscillator of Pamukoff for the speaker taught by Ehrenreich, while still yielding the predictable result of delivering a vibratory stimulus (see MPEP 2143.I, exemplary rationale B).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Pamukoff in view of Yu (US 10,589,116), Pisharodi (US 2017/0348184), and Rahman (US 2018/0085283), as applied to claim 2 above, in further view of Ehrenreich (US 2013/0102937) and Hutcheon (US 2013/0012850).
Regarding claim 4, Pamukoff in view of Yu, Pisharodi, and Rahman disclose the stimulator of claim 2, as discussed above.
Modified Pamukoff further discloses wherein the electromagnetic oscillator holder (Rahman: see aperture in 170 for electromagnetic oscillator 120) includes a central aperture for holding the electromagnetic oscillator (Rahman: see Fig. 1 where 170 includes a central aperture for the analogous electromagnetic oscillator 120).
Modified Pamukoff fails to disclose wherein the electromagnetic oscillator comprises a speaker, and fails to explicitly disclose that the apertures in the housing and on the holder allow for direct contact with the treatment region, given that Rahman uses a layer of material (300) to cover the holder and electromagnetic oscillator.
However, Ehrenreich teaches an electromagnetic oscillator configured as a speaker to vibrate the treatment device (paragraph 167, lines 1-9, and note that the frequencies described in paragraph 168 all fall within the EM spectrum).
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 substituted the electromagnetic oscillator of Pamukoff for the speaker taught by Ehrenreich, while still yielding the predictable result of delivering a vibratory stimulus (see MPEP 2143.I, exemplary rationale B).
Modified Pamukoff still fails to disclose that the apertures in the housing and on the holder allow for direct contact with the treatment region, given that Rahman uses a layer of material (300) to cover the holder and electromagnetic oscillator.
However, Hutcheon teaches that it is advantageous for an electromagnetic oscillator (see vibration motor and vibration nozzle in Fig. 2) to directly contact the treatment region, and shows its electromagnetic oscillator projecting from an aperture in the holder and housing for achieving direct contact with the treatment region (paragraph 31, lines 1-7; Fig. 1).
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 housing of modified Pamukoff to allow the central aperture in the electromagnetic oscillator holder to align with an aperture in the device housing and allow the electromagnetic oscillator to extend therefrom, so that the electromagnetic oscillator was able to directly contact the treatment region, as taught by Hutcheon, in order to directly apply vibratory stimulus to the affected region.
Claims 12-13 are rejected under 35 U.S.C. 103 as being unpatentable over Pamukoff in view of Yu (US 10,589,116) and Pisharodi (US 2017/0348184), as applied to claim 1 above, in further view of Baxter (US 2018/0369064).
Regarding claim 12, Pamukoff in view of Yu and Pisharodi disclose the stimulator of claim 1, as discussed above.
Modified Pamukoff further discloses a control communication interface (Yu: 90) for communicating control signals from the controller (Yu: 92) to the waveform generator (Yu: 91) (Yu: Col. 5, lines 36-41).
Modified Pamukoff fails to explicitly disclose a measurement communication interface for communicating the measurements from the accelerometer to the controller.
However, Baxter teaches a controller (1100) including a measurement communication interface (1116) to allow for communication between the controller (1100) and certain sensors (paragraph 135, lines 1-8, see “transceivers, sensors”).
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 controller of modified Pamukoff to include a measurement communication interface, as taught by Baxter, in order to allow for communication between the controller and the accelerometer (i.e. a sensor) to control the device based on accelerometer feedback, as already contemplated by Pamukoff.
Regarding claim 13, Pamukoff in view of Yu, Pisharodi, and Baxter disclose the stimulator of claim 12, as discussed above.
Presently modified Pamukoff fails to disclose wherein the control communication interface and the measurement communication interface comprise a single connector.
However, Baxter further discloses that the communication connection (1116) is capable of facilitating communication between the controller (1100) and a sensor (paragraph 135, lines 1-7), as previously discussed, and Baxter further indicates that this single connector (i.e. the communication connection 1116) is further capable of additionally communicating with wireless devices (1122) (paragraph 135, lines 1-7).
Given that the control user interface of modified Pamukoff is a smart phone, and Yu contemplates the use of a wireless transceiver for the control communication interface, it would have been obvious to one of ordinary skill in the art before the effect4ive filing date of the claimed invention to substitute the two separate interfaces of Yu and Baxter as presented in modified Pamukoff, with a single connector (i.e. 1116 of Baxter) capable of relaying commands from the control user interface (Yu’s smart phone, analogous to the wireless device 1122 of Baxter) and from the Pamukoff accelerometer to the controller, as taught by Baxter, in order to reduce the number of working components in the device, and reduce manufacture cost and complexity.
Claims 12 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Pamukoff in view of Yu (US 10,589,116) and Pisharodi (US 2017/0348184), as applied to claim 1 above, in further view of Tomita (US 2021/0138240).
Regarding claim 12, Pamukoff in view of Yu and Pisharodi disclose the stimulator of claim 1, as discussed above.
Modified Pamukoff further discloses a control communication interface (Yu: 90) for communicating control signals from the controller (Yu: 92) to the waveform generator (Yu: 91) (Yu: Col. 5, lines 36-41).
Modified Pamukoff fails to explicitly disclose a measurement communication interface for communicating the measurements from the accelerometer to the controller.
However, Tomita teaches a measurement communication interface (wired or wireless connection between 102 and 103) for allowing communication between the controller (103) and certain sensors (102) (paragraph 160, lines 1-4, where paragraph 153, lines 1-4 assert that detection section 102 comprises sensors; Fig. 1).
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 controller of modified Pamukoff to include a measurement communication interface, as taught by Tomita, in order to allow for communication between the controller and the accelerometer (i.e. a sensor) to control the device based on accelerometer feedback, as already contemplated by Pamukoff.
Regarding claim 14, Pamukoff in view of Yu, Pisharodi, and Tomita disclose the stimulator of claim 12, as discussed above.
Modified Pamukoff further discloses wherein the control communication interface and the measurement communication interface comprise separate connectors (Yu: Col. 5, lines 36-41 separate transceiver for communicating with the smart phone, and Tomita: separate interface/connector at paragraph 160, lines 1-4, where paragraph 153, lines 1-4 assert that detection section 102 comprises sensors; Fig. 1, note the separate communication section 104 which communicates with external apparatus 4).
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Pamukoff in view of Yu (US 10,589,116), Pisharodi (US 2017/0348184), and Rahman (US 2018/0085283), as applied to claim 16 above, in further view of Talish (EP 1180057).
Regarding claim 17, Pamukoff in view of Yu, Pisharodi, and Rahman disclose the stimulator of claim 16, as discussed above.
Modified Pamukoff fails to disclose wherein the controller printed circuit board is separate from the frame and the stimulator further comprises a bag for holding the controller printed circuit board and means for securing the bag to the subject.
However, Talish teaches a stimulator (14) (paragraph 37, lines 1-4; Fig. 1) which includes a main operation unit (12) separate from the frame (22) and further comprising a bag (18) for holding the main operation unit (12) and means for securing the bag (18) to the subject (paragraph 37, lines 1-18 and Fig. 1, note the strap attached to 18 in the figure).
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 device such that the printed circuit board of modified Pamukoff was provided as separate from the frame, with its own bag and means for securing the bag to the subject, as a known construction for separating the control and treatment elements of a stimulation device, and so that the separated printed circuit board were protected within the bag, and provided with means to easily carry the bag.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Mischi (US 2021/0228929) is cited for its explanation of activation of muscle stretch and the muscle spindle via mechanical force at paragraph 4.
Jaquish (US 2020/0269079) is cited for its explanation of activation of the muscle spindle via vibration to produce contractions at paragraph 66.
Yamaguchi (US 2020/0156523) is cited for its explanation of an illusory kinetic event induced by vibration due to activation of the muscle spindle and induced muscle stretch at paragraph 55.
Jung (KR 101578203) is cited for its disclosure that “Vibration stimulation stimulates the muscle-tendon complex, which causes Ia (primary core) fiber, the primary ending nerve in the muscle spindle, to respond sensitively to the rate of change in length, By stimulating the neurons, the muscles contract and, in the end, have similar effects to the resistance exercise for traditional muscle strengthening” in its specification.
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/PAIGE KATHLEEN BUGG/Primary Examiner, Art Unit 3785
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