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 .
Election/Restrictions
Applicant’s election without traverse of Invention II (claims 11-20) in the reply filed on 08 December 2025 is acknowledged.
Response to Amendment
The amendment filed 08 December 2025 has been entered. Claim(s) 11-28 are pending in the application; claims 1-10 are cancelled.
Drawings
The drawings are objected to because Fig. 8, step 72 “Classfield” should be “Classified”.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claims 12 and 16 are objected to because of the following informalities:
Claim 12, line 2 “the power” should be –a power—.
Claim 16, line 4 “the comparison” should be –a comparison--.
Claim 16, line 5 “the likelihood” should be –a likelihood--.
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.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: memory device in claim 15-18 and 21-24 and post-processing feature in claims 15 and 21.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
Memory device is thus interpreted as a memory according to Fig. 7 of the instant disclosure.
Post-processing feature is interpreted as steps of processing data performed by the controller after the data been collected by the controller (“controller 50 comprises a processor 51 and a memory device 52 which includes instructions 53 that, when executed by the processor 51, activates a recording cycle 54 and a post-processing feature 55”).
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 12-19 and 21-28 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 12, 15, 19, 21, 25, and 27-28 are rejected for indefiniteness. Claim 11 refers to “at least one first percussion device” and “at least one second percussion device” in lines 4 and 5 of the claim. Claims 12 and 27-28 refer to “the first and second percussion devices” in lines 1-2, while claims 15 and 21 refer to a “respective percussion device” in line 2 and 7-8, to “the percussion device” in line 5, and “the additional percussion device” in line 6, and claims 19 and 25 refer to “the percussion devices”. As there is no consistent convention, it is not clear if these limitations are intended to refer to the same at least one first and at least one second percussion device or if any of these limitations refers to a particular device or devices. The limitations are currently interpreted as referring to the “at least one first percussion device” and “at least one second percussion device”.
Claim 18 recites the limitation “the extraction of sound features” in line 3 of the claim. There is no antecedent basis for this limitation of claim. It is not clear where this step is performed as antecedent is provided in claim 16 rather than claim 15, but claim 18 would be a duplicate of claim 17 if amended to depend from claim 16. The limitation is interpreted as referring to applying a digital signal filter to the sound data prior to sending the sound data to a post processing feature.
Claim 24 recites the limitation “the extraction of sound features” in line 3 of the claim. There is no antecedent basis for this limitation of claim. It is not clear where this step is performed as antecedent is provided in claim 22 rather than claim 21, but claim 24 would be a duplicate of claim 23 if amended to depend from claim 22. The limitation is interpreted as referring to applying a digital signal filter to the sound data prior to sending the sound data to a post processing feature.
Claims 12-18 and 22-27 are additionally rejected under 35 U.S.C. 112(b) as indefinite due to their dependence on claims 12 and 21, which have been rejected as indefinite.
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.
Claim(s) 11-15, 18, 21, 24, and 27-28 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lee (US 20190142686 A1) in view of Shockley (US 20170156976 A1).
Regarding claim 11, Lee teaches a high frequency chest wall oscillation (HFCWO) system (Wearable device 1) comprising
an adjustable garment configured to be positioned on a patient (Article of clothing 6; paragraph 0030—the article of clothing 6 may also include various straps…may be adjustable by one or more buckles 9 for a secure fit to the torso of the body…),
at least one first percussion device positioned on a first side of the garment (oscillator elements 100 and 102 on a first side of the garment; paragraph 0031—each oscillating element (e.g. 100, 101, 102, or 103) may be a bladder (e.g. air-filled) actuator, solenoid, piezoelectric mechanism, electrically actuated hammer, or other compressive or impact device that may provide oscillations to the chest of the user), and
at least one second percussion device positioned on a second side of the garment (Oscillating elements 101 and 103 on a second side of the garment; paragraph 0031),
wherein the garment is adjustable (Paragraph 0030) and first and second percussion devices may be used to target therapy to an upper zone of the patient's lungs or to a lower zone of the patient's lungs (Paragraph 0031—transmit a force to the user’s body (e.g. to specific lobes of the lungs); Fig. 3 shows the at least one first percussion device (100/102) and at least one second percussion device (101/103) may target specifically the upper or lower zones of the lungs; paragraph 0055—the intensity (amplitude) of the pulses generated by the oscillating element, the frequency of the oscillations, the duration of the oscillations, and/or other parameters for each region of the lung may be adjusted to individually control each oscillating element).
However, Lee fails to explicitly disclose the garment is adjustable between a first position locating the first and second percussion devices to target therapy to an upper zone of the patient's lungs and a second position locating the first and second percussion devices to target therapy to a lower zone of the patient's lungs.
Shockley, in the same field of endeavor of a system and method for monitoring use of a wearable chest wall oscillation device, teaches a wearable garment wherein the garment is adjustable between a first position locating the first and second percussion devices to target therapy to an upper zone of the patient's lungs and a second position locating the first and second percussion devices to target therapy to a lower zone of the patient's lungs (Paragraph 0072-0073—the method may include positioning a wearable system on a subject. The method may include adjusting the wearable system such that an oscillation force is applied to at least a first zone and to at least a second zone of the subject (e.g. and possibly more zones))… A system 100 may allow for adjusting where forces are applied to the subject, for example, to what are identified as at least the first zone 220a and the second zone 220b.).
It would have been obvious to one having ordinary skill in the art at the time of filing to modify Lee with the teachings of Shockey, where Lee discloses that oscillating elements may be operated independently to target different regions of the lungs and that a garment is generally adjustable with straps, to adjust the positioning of the garment to target therapy to an upper and lower zone of the lungs as disclosed by Shockley in order to predictably improve the ability of the device to target particular areas for therapy regardless of the body size of a user (see Shockley, paragraph 0073—known HFCWO do not allow for a user adjusting where forces are applied to on the subject. This is problematic because although some known HFCWO systems may come in different sizes to accommodate differently sized subjects, there are far too many people of different sizes and so it is impractical to produce enough differently sized systems for all of the differently sized subjects) and may additionally improve symptoms of different lung disease which benefit from targeting of different areas of the lungs (see Shockley, paragraph 0073-- Applying high frequency forces to zones 220 as opposed to zones 210 may allow for greater remediation of symptoms associated with certain forms of chronic lung disease).
Regarding claim 12, the combination of Lee and Shockley teaches the HFCWO system of claim 11. Lee additionally teaches wherein the first and second percussion devices are operable to vary the power of the therapy delivered to the patient's lungs such that a first power can be delivered at each respective zone (paragraph 0055—the intensity (amplitude) of the pulses generated by the oscillating element, the frequency of the oscillations, the duration of the oscillations, and/or other parameters for each region of the lung may be adjusted to individually control each oscillating element). In particular, the first and second percussion devices of Lee may be individually controlled and adjusted such that the power of the therapy may be the same or different at each respective zone.
Regarding claim 13, the combination of Lee and Shockley teaches the HFCWO system of claim 12. Lee additionally teaches wherein the adjustable garment includes an adjustable strap (paragraph 0030—the article of clothing 6 may also include various straps…may be adjustable by one or more buckles 9 for a secure fit to the torso of the body…).
Regarding claim 14, the combination of Lee and Shockley teaches the HFCWO system of claim 13. Lee additionally teaches wherein the adjustable strap comprises at least one adjustable shoulder strap (paragraph 0030—the article of clothing 6 may also include various straps…may be adjustable by one or more buckles 9 for a secure fit to the torso of the body…; Fig. 1-2, article of clothing 6).
Lee does not explicitly teach at least one adjustable underarm strap. Shockley, in the same field of endeavor, teaches at least one adjustable underarm strap (See straps 120, Fig. 1; paragraph 0078-- In some embodiments, the wearable system may be adjustable at least across a chest and/or portion of a torso of a subject (e.g., as depicted in FIG. 1 using friction fittings and straps 120). In some embodiments, the wearable system may be adjustable at least across one or more shoulders of a subject (e.g., as depicted in FIG. 1).).
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the system of Lee with the underarm strap of Shockley to predictably improve the fit and therapy targeting of the device by allowing for greater adjustment of the wearable garment.
Regarding claim 15, the combination of Lee and Shockley teaches the HFCWO system of claim 14. Lee additionally teaches further comprising a sensor associated with each respective percussion device (Sound detection elements 50-55), and a controller including a processor and a memory device (Controller 4 having RAM 41; paragraph 0043) including instructions that, when executed by the processor, sequentially and independently activates each sensor to begin recording sound data from the patient's respiratory system (Paragraph 0040-0046—the sound detector 3 of the wearable device 1 may be configured to optimally sense all of the adventitious lung sounds…the adventitious lung sounds (e.g. crackles and wheezes) may be monitored before, during, and after chest wall oscillation treatment; paragraph 0056-0057—an activate button 22…may therefore be able to activate (e.g. turn on) or deactivate (e.g. turn off) the wearable device 1), activates the percussion device associated with the respective sensor to simulate manual chest tapping (Paragraph 0040-0046, 0055, 0066—For example, the intensity (amplitude) of the pulses generated by the oscillating element, the frequency of the oscillations, the duration of the oscillations, and/or other parameters for each region of each lung may be adjusted to individually control each oscillating element. For example, each of the duration, frequency, and intensity of the oscillations may be increased, decreased, continued at the same level, or the therapy may be terminated…control by the controller may be based on the assessment score tally, individually on just one parameter, or on a combination of a plurality of parameters. Depending on the assessment score, a frequency, intensity, or duration may be varied in subsequent therapy), collects sound data from the patient's respiratory system (Paragraph 0040-0046), deactivates the additional sensor and the additional percussion device (Paragraph 0040-0046, 0055-0057, 0066), repeats the sequential and independent activation of the sensor, respective percussion device, data collection and deactivation of the sensor and respective percussion device for each set of sensors and percussion devices (Paragraph 0040-0046), and sends the sound data from the additional sensor to a post processing feature (Paragraph 0060—the controller 4 may be configured to export (e.g. wirelessly or wired) the characterizations and calculations of the adventitious lung sounds in a non-readable fashion or readable fashion, such as a graph, table or other suitable chart…the lung sounds may be recorded, measured, graphically displayed, analyzed, and the user treated respective to the analyzed results).
Regarding claim 18, the combination of Lee and Shockley teaches the HFCWO system of claim 15. Lee additionally teaches wherein the memory device includes further instructions that, when executed by the processor, applies a digital signal filter to the sound data prior to performing the extraction of sound features (Paragraph 0044—the controller 4 may also implement filters (e.g. high pass filter, band pass filter, or low pass filter) to isolate the lung sounds from the operation of the chest wall oscillator 2 and/or to filter out background noise).
Regarding claim 21, the combination of Lee and Shockley teaches the HFCWO system of claim 11. Lee additionally teaches further comprising a sensor associated with each respective percussion device (Sound detection elements 50-55), and a controller including a processor and a memory device (Controller 4 having RAM 41; paragraph 0043) including instructions that, when executed by the processor, sequentially and independently activates each sensor to begin recording sound data from the patient's respiratory system (Paragraph 0040-0046—the sound detector 3 of the wearable device 1 may be configured to optimally sense all of the adventitious lung sounds…the adventitious lung sounds (e.g. crackles and wheezes) may be monitored before, during, and after chest wall oscillation treatment; paragraph 0056-0057—an activate button 22…may therefore be able to activate (e.g. turn on) or deactivate (e.g. turn off) the wearable device 1), activates the percussion device associated with the respective sensor to simulate manual chest tapping (Paragraph 0040-0046, 0055, 0066—For example, the intensity (amplitude) of the pulses generated by the oscillating element, the frequency of the oscillations, the duration of the oscillations, and/or other parameters for each region of each lung may be adjusted to individually control each oscillating element. For example, each of the duration, frequency, and intensity of the oscillations may be increased, decreased, continued at the same level, or the therapy may be terminated…control by the controller may be based on the assessment score tally, individually on just one parameter, or on a combination of a plurality of parameters. Depending on the assessment score, a frequency, intensity, or duration may be varied in subsequent therapy), collects sound data from the patient's respiratory system (Paragraph 0040-0046), deactivates the additional sensor and the additional percussion device (Paragraph 0040-0046, 0055-0057, 0066), repeats the sequential and independent activation of the sensor, respective percussion device, data collection and deactivation of the sensor and respective percussion device for each set of sensors and percussion devices (Paragraph 0040-0046), and sends the sound data from the additional sensor to a post processing feature (Paragraph 0060—the controller 4 may be configured to export (e.g. wirelessly or wired) the characterizations and calculations of the adventitious lung sounds in a non-readable fashion or readable fashion, such as a graph, table or other suitable chart…the lung sounds may be recorded, measured, graphically displayed, analyzed, and the user treated respective to the analyzed results).
Regarding claim 24, the combination of Lee and Shockley teaches the HFCWO system of claim 21. Lee additionally teaches wherein the memory device includes further instructions that, when executed by the processor, applies a digital signal filter to the sound data prior to performing the extraction of sound features (Paragraph 0044—the controller 4 may also implement filters (e.g. high pass filter, band pass filter, or low pass filter) to isolate the lung sounds from the operation of the chest wall oscillator 2 and/or to filter out background noise).
Regarding claim 27, the combination of Lee and Shockley teaches the HFCWO system of claim 21. Lee additionally teaches wherein the first and second percussion devices are operable to vary the power of the therapy delivered to the patient's lungs such that a different power can be delivered at each respective zone (Paragraph 0031—transmit a force to the user’s body (e.g. to specific lobes of the lungs); Fig. 3 shows the at least one first percussion device (100/102) and at least one second percussion device (101/103) may target specifically the upper or lower zones of the lungs; paragraph 0055—the intensity (amplitude) of the pulses generated by the oscillating element, the frequency of the oscillations, the duration of the oscillations, and/or other parameters for each region of the lung may be adjusted to individually control each oscillating element). In particular, the first and second percussion devices of Lee may be individually controlled and adjusted such that the power of the therapy may be the same or different at each respective zone.
Regarding claim 28, the combination of Lee and Shockley teaches the HFCWO system of claim 11. Lee additionally teaches wherein the first and second percussion devices are operable to vary the power of the therapy delivered to the patient's lungs such that a different power can be delivered at each respective zone (Paragraph 0031—transmit a force to the user’s body (e.g. to specific lobes of the lungs); Fig. 3 shows the at least one first percussion device (100/102) and at least one second percussion device (101/103) may target specifically the upper or lower zones of the lungs; paragraph 0055—the intensity (amplitude) of the pulses generated by the oscillating element, the frequency of the oscillations, the duration of the oscillations, and/or other parameters for each region of the lung may be adjusted to individually control each oscillating element). In particular, the first and second percussion devices of Lee may be individually controlled and adjusted such that the power of the therapy may be the same or different at each respective zone.
Claim(s) 16-17 and 22-23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lee in view of Shockley, further in view of Maev (US 20190223726 A1).
Regarding claim 16, the combination of Lee and Shockley teaches the HFCWO system of claim 15. Lee additionally teaches wherein the memory device includes further instructions that, when executed by the processor, processes the sound data to extract sound features, classifies the sound features, compares the classified sound features to threshold settings (Paragraph 0038-0046, 0067-0070—the lung sounds may be characterized by calculating one or more of the CALSA parameters…For example, the one or more thresholds for the one or more CALSA parameters may be individually set at a lowest, low, high, or highest value)
However, Lee fails to disclose based on the comparison of the sound features to the threshold settings, predicts the likelihood that the patient is experiencing pleural effusion.
Maev, in the same field of endeavor of a system and method for providing percussion to the chest of a user and measuring sounds from the user’s chest to detect the condition of the user (Paragraph 0009--the apparatus includes a pulsed force generator which is operable to transmit or output to a selected patient target area, a percussion or a mechanical disturbance in the form of a pulse force. The apparatus is provided with one or more sensors which are operable to sense the waves and/or vibrations induced by percussion. Such sensors may include one or more of acoustic sensors… Based on the detected surface vibration and/or return wave properties… providing an indication of the presence or absence of a potential pulmonary disease and/or other patient condition), teaches processing sound data to extract sound features (Paragraph 0009), classifies the sound features (Paragraph 0010, 0031, 0039-- the diagnostic apparatus is provided with a processor which is operable to classify the type of sensed data and/or output signal (here and after collectively an output signal) provided by the analyzer), compares the classified sound features to threshold settings (Paragraph 0019-- sensed waveforms are preferably assessed to identify whether or not the detected wave profile deviates from one or more predetermined profiles by a threshold amount indicative of an identified medical anomaly), and, based on the comparison of the sound features to the threshold settings predicts the likelihood that the patient is experiencing pleural effusion (Paragraph 0007-0009, 0019-- a portable diagnostic analyzer which is operable to provide an indication of either the presence or absence of a potential pulmonary and/or abdominal condition in a patient. Such conditions may include… pleural effusion).
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the system of Lee to utilize the processing to predict a likelihood of pleural effusion of Maev in order to predictably improve the ability of the device to determine the presence of additional medical conditions and anomalies.
Regarding claim 17, the combination of Lee, Shockley, and Maev teaches the HFCWO system of claim 16. Lee additionally teaches wherein the memory device includes further instructions that, when executed by the processor, applies a digital signal filter to the sound data prior to performing the extraction of sound features (Paragraph 0044—the controller 4 may also implement filters (e.g. high pass filter, band pass filter, or low pass filter) to isolate the lung sounds from the operation of the chest wall oscillator 2 and/or to filter out background noise).
Regarding claim 22, the combination of Lee and Shockley teaches the HFCWO system of claim 1. Lee additionally teaches wherein the memory device includes further instructions that, when executed by the processor, processes the sound data to extract sound features, classifies the sound features, compares the classified sound features to threshold settings (Paragraph 0038-0046, 0067-0070—the lung sounds may be characterized by calculating one or more of the CALSA parameters…For example, the one or more thresholds for the one or more CALSA parameters may be individually set at a lowest, low, high, or highest value)
However, Lee fails to disclose based on the comparison of the sound features to the threshold settings, predicts the likelihood that the patient is experiencing pleural effusion.
Maev, in the same field of endeavor of a system and method for providing percussion to the chest of a user and measuring sounds from the user’s chest to detect the condition of the user (Paragraph 0009--the apparatus includes a pulsed force generator which is operable to transmit or output to a selected patient target area, a percussion or a mechanical disturbance in the form of a pulse force. The apparatus is provided with one or more sensors which are operable to sense the waves and/or vibrations induced by percussion. Such sensors may include one or more of acoustic sensors… Based on the detected surface vibration and/or return wave properties… providing an indication of the presence or absence of a potential pulmonary disease and/or other patient condition), teaches processing sound data to extract sound features (Paragraph 0009), classifies the sound features (Paragraph 0010, 0031, 0039-- the diagnostic apparatus is provided with a processor which is operable to classify the type of sensed data and/or output signal (here and after collectively an output signal) provided by the analyzer), compares the classified sound features to threshold settings (Paragraph 0019-- sensed waveforms are preferably assessed to identify whether or not the detected wave profile deviates from one or more predetermined profiles by a threshold amount indicative of an identified medical anomaly), and, based on the comparison of the sound features to the threshold settings predicts the likelihood that the patient is experiencing pleural effusion (Paragraph 0007-0009, 0019-- a portable diagnostic analyzer which is operable to provide an indication of either the presence or absence of a potential pulmonary and/or abdominal condition in a patient. Such conditions may include… pleural effusion).
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the system of Lee to utilize the processing to predict a likelihood of pleural effusion of Maev in order to predictably improve the ability of the device to determine the presence of additional medical conditions and anomalies.
Regarding claim 23, the combination of Lee, Shockley, and Maev teaches the HFCWO system of claim 22. Lee additionally teaches wherein the memory device includes further instructions that, when executed by the processor, applies a digital signal filter to the sound data prior to performing the extraction of sound features (Paragraph 0044—the controller 4 may also implement filters (e.g. high pass filter, band pass filter, or low pass filter) to isolate the lung sounds from the operation of the chest wall oscillator 2 and/or to filter out background noise).
Claim(s) 19-20 and 25-26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lee in view of Shockley, further in view of Drlik (US 20140005579 A1).
Regarding claim 19, the combination of Lee and Shockley teaches the HFCWO system of claim 11. Lee additionally teaches wherein the percussion devices administer at a frequency no more than 20 Hertz (Paragraph 0035—the controller 4 may individually configure each oscillating element of the chest wall oscillator 2 to vibrate at a different frequency (e.g. between 0 Hz and 25 Hz, between 5 Hz and 20 Hz, etc.), at a different intensity, and for a different duration).
However, Lee fails to explicitly disclose a therapy force of no more than 18 Newton.
Drlik, in the same field of endeavor of a wearable device for providing percussion therapy force (Abstract, paragraph 0001), teaches a percussion device administers a therapy force of no more than 18 Newton (Paragraph 0038-- The rigid elements (30), actuators (40) and the controller (60) may be tuned to produce desired force specifications… The actuator (40) comprises three springs having a spring rate of 10 lbs per inch and the actuators (40) are "preloaded" to apply a force of approximately 1 lb, within a reasonable range of 0 to 5 lbs. It is noted that a force of 1 lb equates to 4.448N and 5lbs equates to 22.24N).
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the system of Lee to include the therapy force of Drlik in order to predictably improve the effectiveness of the device, as Drlik additionally discloses that this range of forces is “similar to the magnitude of forces applied by a therapist administering manual CPT” (Paragraph 0038) such that it is known to be effective.
Regarding claim 20, the combination of Lee and Shockley teaches the HFCWO system of claim 11. Lee additionally teaches wherein the frequency of the therapy force is at a range of 5 to 20 Hertz (Paragraph 0035—the controller 4 may individually configure each oscillating element of the chest wall oscillator 2 to vibrate at a different frequency (e.g. between 0 Hz and 25 Hz, between 5 Hz and 20 Hz, etc.), at a different intensity, and for a different duration).
However, Lee fails to disclose the therapy force is administered at a range of 3 to 18 Newton.
Drlik, in the same field of endeavor of a wearable device for providing percussion therapy force (Abstract, paragraph 0001), teaches a percussion device therapy force is administered at a range of 3 to 18 Newton (Paragraph 0038-- The rigid elements (30), actuators (40) and the controller (60) may be tuned to produce desired force specifications… The actuator (40) comprises three springs having a spring rate of 10 lbs per inch and the actuators (40) are "preloaded" to apply a force of approximately 1 lb, within a reasonable range of 0 to 5 lbs. It is noted that a force of 1 lb equates to 4.448N and 5lbs equates to 22.24N).
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the system of Lee to include the therapy force of Drlik in order to predictably improve the effectiveness of the device, as Drlik additionally discloses that this range of forces is “similar to the magnitude of forces applied by a therapist administering manual CPT” (Paragraph 0038) such that it is known to be effective.
Regarding claim 25, the combination of Lee and Shockley teaches the HFCWO system of claim 11. Lee additionally teaches wherein the percussion devices administer at a frequency no more than 20 Hertz (Paragraph 0035—the controller 4 may individually configure each oscillating element of the chest wall oscillator 2 to vibrate at a different frequency (e.g. between 0 Hz and 25 Hz, between 5 Hz and 20 Hz, etc.), at a different intensity, and for a different duration).
However, Lee fails to explicitly disclose a therapy force of no more than 18 Newton.
Drlik, in the same field of endeavor of a wearable device for providing percussion therapy force (Abstract, paragraph 0001), teaches a percussion device administers a therapy force of no more than 18 Newton (Paragraph 0038-- The rigid elements (30), actuators (40) and the controller (60) may be tuned to produce desired force specifications… The actuator (40) comprises three springs having a spring rate of 10 lbs per inch and the actuators (40) are "preloaded" to apply a force of approximately 1 lb, within a reasonable range of 0 to 5 lbs. It is noted that a force of 1 lb equates to 4.448N and 5lbs equates to 22.24N).
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the system of Lee to include the therapy force of Drlik in order to predictably improve the effectiveness of the device, as Drlik additionally discloses that this range of forces is “similar to the magnitude of forces applied by a therapist administering manual CPT” (Paragraph 0038) such that it is known to be effective.
Regarding claim 26, the combination of Lee and Shockley teaches the HFCWO system of claim 21. Lee additionally teaches wherein the frequency of the therapy force is at a range of 5 to 20 Hertz (Paragraph 0035—the controller 4 may individually configure each oscillating element of the chest wall oscillator 2 to vibrate at a different frequency (e.g. between 0 Hz and 25 Hz, between 5 Hz and 20 Hz, etc.), at a different intensity, and for a different duration).
However, Lee fails to disclose the therapy force is administered at a range of 3 to 18 Newton.
Drlik, in the same field of endeavor of a wearable device for providing percussion therapy force (Abstract, paragraph 0001), teaches a percussion device therapy force is administered at a range of 3 to 18 Newton (Paragraph 0038-- The rigid elements (30), actuators (40) and the controller (60) may be tuned to produce desired force specifications… The actuator (40) comprises three springs having a spring rate of 10 lbs per inch and the actuators (40) are "preloaded" to apply a force of approximately 1 lb, within a reasonable range of 0 to 5 lbs. It is noted that a force of 1 lb equates to 4.448N and 5lbs equates to 22.24N).
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the system of Lee to include the therapy force of Drlik in order to predictably improve the effectiveness of the device, as Drlik additionally discloses that this range of forces is “similar to the magnitude of forces applied by a therapist administering manual CPT” (Paragraph 0038) such that it is known to be effective.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANNA ROBERTS whose telephone number is (571)272-7912. The examiner can normally be reached M-F 8:30-4:30 EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Alexander Valvis can be reached at (571) 272-4233. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/ANNA ROBERTS/Examiner, Art Unit 3791