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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 has been entered.
The Examiner acknowledges the amendments to claims 6, 7, 9 and 22, and the cancellation of claims 3, 5, and 16. Claims 1, 2, 4, 6-15 and 17-23 are currently pending.
Response to Arguments
Applicant’s arguments, see remarks, filed July 15, 2025 have been fully considered but they are not persuasive. While Applicant’s amendments have overcome some of the previous claim objections, claim 22 is still objected to for minor informalities. See claim objections below.
With respect to the rejection of the claims under 35 USC 112(b), though Applicant’s amendments have overcome some of the previous rejections under 35 USC 112(b), indefiniteness issues still remain within the claims. Regarding claims 1, 19 & 21, the phrase “which training mode is limited in time” is still unclear. Applicant argues that a person of ordinary skill in the art knows that limited in time means a limitation in advance, and that in the context of the instant application, it means a training course that is limited in time. Applicant further argues that paragraphs 0039 & 0061 of the specification disclose that the training mode is limited over time, but as claim 1 (and similarly, claims 19 & 21) recites “wherein the control device is configured to stop or to interrupt the training mode as a function of the information of the muscle state” at lines 15-16, it is still unclear whether the time that the training mode is limited to is determined when it goes into the training mode or whether the limited time of the training mode is due to the stopping or interrupting of the training mode once spasming/fatigue of the user reaches a certain threshold. Applicant’s arguments fail to address this, and as such, are found to be unpersuasive. Regarding claim 4, it is unclear how claim 4 further limits claim 1. Applicant argues that claim 4 further limits the features of claim 1 by providing that the control device is capable of affecting the training mode with respect to the training duration. Claim 1 recites “wherein the control device is further configured to operate the breathing influencing device as a function of the information on the muscle state in a training mode, which training mode is limited in time, with a training intensity” at lines 9-11 and “wherein the control device is configured to stop or to interrupt the training mode as a function of the information on the muscle state” at lines 15-16. Therefore, the examiner disagrees with Applicant’s argument that claim 4 further limits the features of claim 1 by providing that the control device is capable of affecting the training mode with respect to the training duration because claim 1 recites that the control device is configured to operate the breathing influencing device in a training mode that is limited in time with a training intensity, and further that the control device can stop or interrupt the training mode based upon information on the muscle state (i.e., affecting the training mode with respect to the training duration based upon information on the muscle state). Therefore, it is still unclear as to how claim 4 further limits claim 1. Regarding claim 6, it is still unclear how a signal that triggers stopping or interruption of a training mode is used to indicate at least one element of an expiratory activity, an inspiratory activity, harmful pressure conditions in the lungs, cough or hiccup, and detection of pathological states, which may be harmful to the person. Applicant argues that a person of ordinary skill in the art would understand that a harmful pressure condition in the lungs is detected and the signal is generated such that the signal is indicative of this harmful situation, but Applicant is silent as to how the signal that triggers stopping or interruption of a training mode is used to indicate the harmful pressure condition in the lungs. Regarding claim 7, it is still unclear how a signal that triggers stopping or interruption of a training mode is used to indicate at least one element of a change/deviation in a muscle group distribution and an anticyclic activity above a threshold considered to be intolerable. Applicant argues that claim 7 further limits claim 1 by indicating what may be associated with the signal, but Applicant fails to explain how a signal that triggers stopping or interruption of a training mode is used to indicate at least one element of a change/deviation in a muscle group distribution and an anticyclic activity above a threshold considered to be intolerable. See 35 USC 112(b) rejections below.
Regarding the rejection of the claims under 35 USC 103, Applicant argues that the combination of the previously used prior art fails to teach or suggest stopping or interrupting a training mode as a function of a signal, wherein the signal indicates at least one of sustained spasms and muscle fatigue above a threshold considered to be intolerable. The Examiner respectfully disagrees with the argument that the previously used prior art references fail to teach or suggest stopping or interrupting a training mode as a function of information on a muscle state. In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., the Maceachern reference fails to disclose an automatic termination of a training mode) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). The “Martin” reference does teach stopping or interrupting the training mode as a function of the information on the muscle state of the user (i.e., a valve supplying breathing gas to a patient ceases to deliver flow to a patient if a inspiratory training pressure is not maintained by the patient) (see Martin, par 0014). Furthermore, Martin teaches that the detection, via a sensing assembly, of low inspiratory flow rates and tidal volumes that are abnormally low due to a patient’s inability to sustain an inspiratory negative pressure causes the system to automatically implement reducing the inspiratory training pressure (i.e., stopping or interrupting the training pressure based upon the detected low inspiratory flow rates/tidal volumes) (see Martin, par 0046). Therefore, Martin as modified by Gumery and Maceachern discloses stopping or interrupting a training mode as a function of information on a muscle state. See 35 USC 103 rejections below.
Claim Objections
Claim 22 is objected to because of the following informalities: "wherein with the . 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: detection device, breathing influencing device, and control device in claims 1, 19 & 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. As described in the specification, the detection device comprises one or more sensors, sensor elements, electrodes or electrode pairs, surface electrodes, pressure sensors, volume sensors, flow sensors, or gas concentration sensors, the breathing influencing device comprises a plurality of sensors that detect the extent of breathing difficulty and convert the breathing difficulty into signals, an inhalation part and an exhalation part, and pneumatic structures such as flexible tubes and a mask that allow the device to be coupled to a person, and the control device is any desired controller or processor or a programmable or programmed hardware component.
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 1-2, 4, 6-15 and 17-23 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.
Claim 1 recites "which training mode is limited in time" at lines 10-11, and “wherein the control device is configured to stop or to interrupt the training mode as a function of the information of the muscle state” at lines 15-16. The phrase "which training mode is limited in time" is unclear because it is unclear whether the time that the training mode is limited to is determined when it goes into the training mode or whether the limited time of the training mode is due to the stopping or interrupting of the training mode once spasming/fatigue of the user reaches a certain threshold. The Examiner respectfully requests clarification of this claim limitation. For examination purposes, it will be interpreted that the training mode occurs for a predetermined period of time. Claims 19 & 21 are similarly rejected and interpreted.
Claim 4 recites "wherein the control device is configured to influence the training mode with respect to a training duration". As claim 1 recites "wherein the control device is further configured to operate the breathing influencing device as a function of the information on the muscle state in a training mode, which training mode is limited in time, with a training intensity" at lines 9-11, it is unclear how claim 4 further limits claim 1. The Examiner respectfully requests clarification of how claim 4 further limits claim 1.
Claim 6 recites “wherein the signal, which triggers stopping or interruption of the training mode, further indicates at least one element of the group of[:] an expiratory activity, an inspiratory activity, harmful pressure conditions in the lungs, cough or hiccup, and detection of pathological states, which may be harmful to the person”. It is unclear how a signal that triggers stopping or interruption of a training mode is used to indicate at least one element of an expiratory activity, an inspiratory activity, harmful pressure conditions in the lungs, cough or hiccup, and detection of pathological states, which may be harmful to the person. The examiner respectfully requests clarification of this claim limitation. For examination purposes, it will be interpreted that the signal which triggers stopping or interruption of the training mode indicates an inspiratory training pressure that has not been sustained.
Claim 7 recites “wherein the signal, which triggers stopping or interruption of the training mode, indicates at least one piece of information on at least one element of the group of[:] a change/deviation in a muscle group distribution and an anticyclic activity above a threshold considered to be intolerable”. It is unclear how a signal that triggers stopping or interruption of a training mode is used to indicate at least one element of a change/deviation in a muscle group distribution and an anticyclic activity above a threshold considered to be intolerable. The examiner respectfully requests clarification of this claim limitation. For examination purposes, it will be interpreted that the signal which triggers stopping or interruption of the training mode indicates a deviation from the inspiratory training pressure that the user is not able to sustain.
Dependent claims are similarly rejected and interpreted as their base claim.
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 nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-2, 4, 6-15, 17-21 & 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over US Patent Application Publication 20090229611, hereinafter referenced as "Martin"--previously cited-- in view of US Patent Application Publication 20100256513, hereinafter referenced as "Gumery"—previously cited—and in further view of US Patent Application Publication 20150272501 –as previously cited--, hereinafter referenced as “Maceachern”.
With respect to claim 1, Martin teaches a device for influencing the inspiratory muscles of a person, the device comprising:
a detection device (i.e., a sensing assembly) for detecting various parameters such as pressure and flow of the breath of a user (see Martin, par 0039, 0043, 0046, fig. 1);
a breathing influencing device (i.e., a ventilator that supplies breathing gases to a patient) (see Martin, par 0037 & 0039, fig. 1); and
a control device (i.e., a microcontroller assembly processing system) (see Martin, par 0039, 0044, fig. 1) for controlling the detection device and the breathing influencing device,
wherein the control device is further configured to operate the breathing influencing device as a function of the information on the muscle state in a training mode, which is limited in time, with a training intensity (i.e., the breathing influencing device is operated based upon information regarding a person’s muscle state such as inspiratory pressure while training at a predetermined training intensity and for a predetermined period of time) (see Martin, par 0014, 0026, 0035, 0041, 0051),
wherein the control device is configured to stop or to interrupt the training mode as a function of the information on the muscle state, wherein the stopping or the interruption of the training mode is carried out as a function of a signal, wherein the signal indicates at least one of: sustained spasms and muscle fatigue above a threshold considered to be intolerable (i.e., a valve supplying breathing gas to a patient ceases to deliver flow to a patient if a inspiratory training pressure is not maintained by the patient, and further when the patient is experiencing fatigue which inhibits them from sustaining an inspiratory negative pressure, low inspiratory flow rates and tidal volumes are detected by sensors causes the system to automatically implement reducing the inspiratory training pressure) (see Martin, par 0014 & 0046).
Martin further teaches an evaluation module that evaluates patient efforts by using the patient’s muscle state information to determine if the patient is working at the ideal training intensity (see Martin, par 0022), and determining a training mode based upon the patient’s response to training, such as their inspiratory flow rate or tidal volume (see Martin, par 0046).
Martin does not teach that the detection device detects one or more electromyographic signals of a person, nor that the control device is configured to determine in the training mode information on a muscle state of an inspiratory muscle of the person based on the one or more electromyographic signals, nor that the control device is configured to determine the information on the muscle state as a function of the one or more electromyographic signals that indicate an intensity of fatigue and/or an intensity of a spasm.
Gumery teaches detecting one or more electromyographic signals of a person (i.e., detecting electromyographic activity of a patient’s thorax to determine the beginning of thoracic inspiratory contractions) (see Gumery, par 0006-0007, 0019, fig. 1), and a control device that is configured to determine information on a muscle state of an inspiratory muscle of the person based on the electromyographic signal (i.e., a digital processor that receives the digitized electromyographic signal and performs analysis on the signals to determine parameters such as delay, sliding averages, or a comparison to a threshold) (see Gumery, par 0025-0026).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Martin to detect electromyographic signals of a person, and to determine in the training mode information on a muscle state of an inspiratory muscle of a person based upon the electromyographic signal, as taught by Gumery, because detecting electromyographic signals and using them in the control device to determine information on a muscle state of a person provides another metric for analyzing a patient’s respiratory state that can be used to assess what training the person needs (see Gumery, par 0005).
Martin as modified by Gumery fails to teach the control device is configured to determine the information on the muscle state as a function of the one or more electromyographic signals that indicate an intensity of fatigue and/or an intensity of a spasm.
Maceachern teaches systems, methods, and devices for acquiring and processing physiological signals, wherein the systems, methods, and devices acquire a plurality of electrical signals, including EMG signals (see Maceachern, par 0049). The acquired EMG signals can be used to track muscle fatigue of a user by measuring decreases in mean and median frequencies of the EMG signals (see Maceachern, par 0054). Further, a fatigue alert based upon the tracked fatigue can alert the user of when a fatigue trend is identified, such that the user does not overtrain their muscles (see Maceachern, par 0054).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Martin as modified by Gumery such that the control device is configured to determine the information on the muscle state as a function of the one or more electromyographic signals that indicate an intensity of fatigue and/or an intensity of a spasm because that enables a user to prevent overtraining their muscles when fatigue is detected based upon the user’s EMG signals (see Maceachern, par 0054).
With respect to claim 2, Martin in view of Gumery and in further view of Maceachern teaches the device in accordance with claim 1. Martin further teaches that the control device is configured to carry out the training mode such that it is difficult for the person to breathe for a duration of time for training the inspiratory muscles (i.e., the breathing influencing device increases the power of breathing range for the user for a duration of time in order to strengthen the inspiratory muscles of the user) (see Martin, par 0054-0056).
With respect to claim 4, Martin in view of Gumery and in further view of Maceachern teaches the device for influencing the inspiratory muscles of a person in accordance with claim 1. Martin further teaches that the control device is configured to influence the training mode with respect to a training duration (i.e., the control device controls the ventilator to provide a duration of the exercise/training session) (see Martin, par 0056).
With respect to claim 6, Martin in view of Gumery and in further view of Maceachern teaches the device for influencing the inspiratory muscles of a person in accordance with claim 1.
Martin further teaches the signal, which triggers stopping or interruption of the training mode further indicates at least one element of the group of:
An expiratory activity,
An inspiratory activity (i.e., an inspiratory training pressure that has not been sustained) (see Martin, par 0014),
Harmful pressure conditions in the lungs,
Cough or hiccup,
And detection of pathological states, which may be harmful to the person.
With respect to claim 7, Martin in view of Gumery and in further view of Maceachern teaches the device for influencing the inspiratory muscles of a person in accordance with claim 1.
Martin further teaches the signal, which triggers stopping or interruption of the training mode indicates at least one piece of information on at least one element of the group of:
a change/deviation in the muscle group distribution (i.e., a deviation from the inspiratory training pressure that the user is not able to sustain) (see Martin, par 0014) and
an anticyclic activity above a threshold considered to be intolerable.
With respect to claim 8, Martin in view of Gumery and in further view of Maceachern teaches the device for influencing the inspiratory muscles of a person in accordance with claim 1.
Martin further teaches that the control device is configured to output parameters of the training mode and/or parameters of a breathing performance of the person during the duration of the training mode or subsequent to the training mode of the breathing influencing device (i.e., as an output variable, the inspiratory training pressure is provided to the user) (see Martin, par 0061-0063),
wherein the control device is further configured to carry out the output optically and/or haptically and/or acoustically and relative to a target variable for the person (i.e., visual feedback is provided on a ventilator display that allows a user to obtain immediate feedback regarding their training efforts) (see Martin, par 0021, 0060-0063).
With respect to claim 9, Martin in view of Gumery and in further view of Maceachern teaches the device for influencing the inspiratory muscles of a person in accordance with claim 8. Martin further teaches that the control device is configured to initiate and/or parameterize operation of the training mode of the breathing influencing device for the person (i.e., the training is initiated by the ventilator that is controlled by the control device) (see Martin, par 0060).
With respect to claim 10, Martin in view of Gumery and in further view of Maceachern teaches the device for influencing the inspiratory muscles of a person in accordance with claim 1. Martin further teaches that the control device is configured to provide feedback on a training course and/or attainment of a goal by maneuvers of the breathing influencing device (i.e., the ventilator controlled by the control device provides training parameters that can be displayed during training and used as goals or targets to provide patient feedback) (see Martin, par 0060).
With respect to claim 11, Martin in view of Gumery and in further view of Maceachern teaches the device for influencing the inspiratory muscles of a person in accordance with claim 1. Martin further teaches that the control device is configured to determine the information on the muscle state as a function of signals that indicate an intensity of an expiratory activity (i.e., the patient inspired flow is monitored by the device to determine evidence of fatigue of the patient which determines the muscle state of the patient and the inspiratory training pressure they can endure) (see Martin, par 0046).
With respect to claim 12, Martin in view of Gumery and in further view of Maceachern teaches the device for influencing the inspiratory muscles of a person in accordance with claim 11. Martin further teaches that the control device is configured to determine an acceptable target intensity of the fatigue and/or of the spasm and/or of an expiratory activity, and wherein the acceptable target intensity is configured as a target range or goal that is variable over time (i.e., the patient inspired flow is monitored by the device to determine evidence of fatigue of the patient which determines the muscle state of the patient and the inspiratory training pressure they can endure) (see Martin, par 0046).
With respect to claim 13, Martin in view of Gumery and in further view of Maceachern teaches the device for influencing the inspiratory muscles of a person in accordance with claim 11. Martin further teaches that the control device is configured to determine an acceptable target intensity of the fatigue and/or of the spasm and/or of an expiratory activity, and wherein the acceptable target intensity is configured as a target range or goal that is constant over time (i.e., the patient inspired flow is monitored by the device to determine evidence of fatigue of the patient which determines the muscle state of the patient and the inspiratory training pressure they can endure, which is a pre-selected value) (see Martin, par 0034, 0036, 0042, 0046, 0053).
With respect to claim 14, Martin in view of Gumery and in further view of Maceachern teaches the device for influencing the inspiratory muscles of a person in accordance with claim 1. Martin further teaches that the control device is configured to determine the information on the muscle state as a function of signals that comprise information on diaphragm muscles and/or on intercostal muscles and/or antagonist muscles (i.e., the muscle state information is determined upon the inspiratory muscles that are used to generate airflow into the lungs, such as the diaphragm and intercostal muscles) (see Martin, par 0012).
With respect to claim 15, Martin in view of Gumery and in further view of Maceachern teaches the device for influencing the inspiratory muscles of a person in accordance with claim 1. Martin further teaches that the control device is configured to determine the information on the muscle state as a function of a pneumatic signal (i.e., the ventilator has a pneumatic subsystem, and therefore uses pneumatic signals to quantify the muscle state of the person) (see Martin, par 0037, 0044).
With respect to claim 17, Martin in view of Gumery and in further view of Maceachern teaches the device for influencing the inspiratory muscles of a person in accordance with claim 1. Martin further teaches that the control device is further configured to carry out a maneuver to determine the muscle state of the person by targeted stressing (i.e., the inspiratory muscles strength training is done at a high intensity to characterize the muscle state of the patient) (see Martin, par 0017, 0055).
With respect to claim 18, Martin in view of Gumery and in further view of Maceachern teaches the device for influencing the inspiratory muscles of a person in accordance with claim 17. Martin further teaches that the control device is further configured to output the results of the maneuver and/or parameters of a breathing performance always relative to target values for the person and/or parameters of the training mode (see Martin, par 0021, 0060-0063).
With respect to claim 19, Martin teaches a breathing unit for ventilating a person, comprising a device for influencing the inspiratory muscles of the person, the device comprising:
a detection device (i.e., a sensing assembly) for detecting various parameters such as pressure and flow of the breath of a user (see Martin, par 0039, 0043, 0046, fig. 1);
a breathing influencing device (i.e., a ventilator that supplies breathing gases to a patient) (see Martin, par 0037 & 0039, fig. 1); and
a control device (i.e., a microcontroller assembly processing system) (see Martin, par 0039, 0044, fig. 1) for controlling the detection device and the breathing influencing device,
wherein the control device is further configured to operate the breathing influencing device as a function of the information on the muscle state in a training mode, which training mode is limited in time, with a training intensity (i.e., the breathing influencing device is operated based upon information regarding a person’s muscle state such as inspiratory pressure while training at a predetermined training intensity) (see Martin, par 0014, 0026, 0041, 0051),
wherein the control device is configured to stop or to interrupt the training mode as a function of the information on the muscle state, wherein the stopping or the interruption of the training mode is carried out as a function of a signal, wherein the signal indicates at least one of: sustained spasms and muscle fatigue above a threshold considered to be intolerable (i.e., a valve supplying breathing gas to a patient ceases to deliver flow to a patient if a inspiratory training pressure is not maintained by the patient, and further when the patient is experiencing fatigue which inhibits them from sustaining an inspiratory negative pressure, low inspiratory flow rates and tidal volumes are detected by sensors causes the system to automatically implement reducing the inspiratory training pressure) (see Martin, par 0014 & 0046).
Martin further teaches an evaluation module that evaluates patient efforts by using the patient’s muscle state information to determine if the patient is working at the ideal training intensity (see Martin, par 0022), and determining a training mode based upon the patient’s response to training, such as their inspiratory flow rate or tidal volume (see Martin, par 0046).
Martin does not teach that the detection device detects one or more electromyographic signals of a person, nor that the control device is configured to determine information on a muscle state of an inspiratory muscle of the person based on the one or more electromyographic signals, nor that the control device is configured to determine in the training mode the information on the muscle state as a function of the one or more electromyographic signals that indicate an intensity of fatigue and/or an intensity of a spasm.
Gumery teaches detecting one or more electromyographic signals of a person (i.e., detecting electromyographic activity of a patient’s thorax to determine the beginning of thoracic inspiratory contractions) (see Gumery, par 0006-0007, 0019, fig. 1), and a control device that is configured to determine information on a muscle state of an inspiratory muscle of the person based on the electromyographic signal (i.e., a digital processor that receives the digitized electromyographic signal and performs analysis on the signals to determine parameters such as delay, sliding averages, or a comparison to a threshold) (see Gumery, par 0025-0026).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Martin to detect electromyographic signals of a person, and to determine information on a muscle state of an inspiratory muscle of a person based upon the electromyographic signal, as taught by Gumery, because detecting electromyographic signals and using them in the control device to determine information on a muscle state of a person provides another metric for analyzing a patient’s respiratory state that can be used to assess what training the person needs (see Gumery, par 0005).
Martin as modified by Gumery fails to teach the control device is configured to determine the information on the muscle state as a function of the one or more electromyographic signals that indicate an intensity of fatigue and/or an intensity of a spasm.
Maceachern teaches systems, methods, and devices for acquiring and processing physiological signals, wherein the systems, methods, and devices acquire a plurality of electrical signals, including EMG signals (see Maceachern, par 0049). The acquired EMG signals can be used to track muscle fatigue of a user by measuring decreases in mean and median frequencies of the EMG signals (see Maceachern, par 0054). Further, a fatigue alert based upon the tracked fatigue can alert the user of when a fatigue trend is identified, such that the user does not overtrain their muscles (see Maceachern, par 0054).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Martin as modified by Gumery such that the control device is configured to determine the information on the muscle state as a function of the one or more electromyographic signals that indicate an intensity of fatigue and/or an intensity of a spasm because that enables a user to prevent overtraining their muscles when fatigue is detected based upon the user’s EMG signals (see Maceachern, par 0054).
With respect to claim 20, Martin in view of Gumery and in further view of Maceachern teaches the breathing unit for ventilating a person in accordance with claim 19. Martin further teaches that the control device is further configured to carry out the training mode as a change in a breathing assist of the person, which change is limited in time (i.e., the breathing unit is used for assisted breathing to prevent or reduce the weakening of inspiratory muscles to reduce the weaning time after treatment with a ventilator), for training the inspiratory muscles of the person (see Martin, par 0026).
With respect to claim 21, Martin teaches a process comprising the steps of:
providing a program code, the program code is executed on a computer, on a processor or on a programmable hardware component (see Martin, par 0066-0069);
providing a breathing influencing device comprising:
a detection device (i.e., a sensing assembly) for detecting various parameters such as pressure and flow of the breath of a user (see Martin, par 0039, 0043, 0046, fig. 1);
a breathing influencing device (i.e., a ventilator that supplies breathing gases to a patient) (see Martin, par 0037 & 0039, fig. 1); and
a control device (i.e., a microcontroller assembly processing system) (see Martin, par 0039, 0044, fig. 1) for controlling the detection device and the breathing influencing device,
wherein the control device is further configured to operate the breathing influencing device as a function of the information on the muscle state in a training mode, which training mode is limited in time, with a training intensity (i.e., the breathing influencing device is operated based upon information regarding a person’s muscle state such as inspiratory pressure while training at a predetermined training intensity) (see Martin, par 0014, 0026, 0041, 0051),
wherein the control device is configured to stop or to interrupt the training mode as a function of the information on the muscle state, wherein the stopping or the interruption of the training mode is carried out as a function of a signal, wherein the signal indicates at least one of: sustained spasms and muscle fatigue above a threshold considered to be intolerable (i.e., a valve supplying breathing gas to a patient ceases to deliver flow to a patient if a inspiratory training pressure is not maintained by the patient, and further when the patient is experiencing fatigue which inhibits them from sustaining an inspiratory negative pressure, low inspiratory flow rates and tidal volumes are detected by sensors causes the system to automatically implement reducing the inspiratory training pressure) (see Martin, par 0014 & 0046).
Martin further teaches an evaluation module that evaluates patient efforts by using the patient’s muscle state information to determine if the patient is working at the ideal training intensity (see Martin, par 0022), and determining a training mode based upon the patient’s response to training, such as their inspiratory flow rate or tidal volume (see Martin, par 0046).
Martin does not teach that the execution of the program code enables the detection device to detect an electromyographic signal of a person, nor that the execution of the program code enables the control device to determine information on a muscle state of an inspiratory muscle of the person based on an electromyographic signal, nor that the execution of the program code enables the control device to determine the information on the muscle state as a function of the one or more electromyographic signals that indicate an intensity of fatigue and/or an intensity of a spasm.
Gumery teaches detecting one or more electromyographic signals of a person (i.e., detecting electromyographic activity of a patient’s thorax to determine the beginning of thoracic inspiratory contractions) (see Gumery, par 0006-0007, 0019, fig. 1), and a control device that is configured to determine information on a muscle state of an inspiratory muscle of the person based on the one or more electromyographic signals (i.e., a digital processor that receives the digitized electromyographic signal and performs analysis on the signals to determine parameters such as delay, sliding averages, or a comparison to a threshold) (see Gumery, par 0025-0026).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the program code of Martin to detect electromyographic signals of a person, and to determine information on a muscle state of an inspiratory muscle of a person based upon the electromyographic signal, as taught by Gumery, because detecting electromyographic signals and using them in the control device to determine information on a muscle state of a person provides another metric for analyzing a patient’s respiratory state that can be used to assess what training the person needs (see Gumery, par 0005).
Martin in view of Gumery fails to teach that the execution of the program code enables the control device to determine the information on the muscle state as a function of the one or more electromyographic signals that indicate an intensity of fatigue and/or an intensity of a spasm.
Maceachern teaches systems, methods, and devices for acquiring and processing physiological signals, wherein the systems, methods, and devices acquire a plurality of electrical signals, including EMG signals (see Maceachern, par 0049). The acquired EMG signals can be used to track muscle fatigue of a user by measuring decreases in mean and median frequencies of the EMG signals (see Maceachern, par 0054). Further, a fatigue alert based upon the tracked fatigue can alert the user of when a fatigue trend is identified, such that the user does not overtrain their muscles (see Maceachern, par 0054).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Martin as modified by Gumery such that the control device is configured to determine the information on the muscle state as a function of the one or more electromyographic signals that indicate an intensity of fatigue and/or an intensity of a spasm because that enables a user to prevent overtraining their muscles when fatigue is detected based upon the user’s EMG signals (see Maceachern, par 0054).
With respect to claim 23, Martin in view of Gumery and in further view of Maceachern teaches the device for influencing the respiratory muscles of a person in accordance with claim 1, and further teaches the control device is further configured to determine the intensity of the fatigue and/or the intensity of the spasm prior to failure of the inspiratory muscle to perform a respiratory task (i.e., acquired EMG signals can be used to track muscle fatigue of a user by measuring decreases in mean and median frequencies of the EMG signals, and further, a fatigue alert based upon the tracked fatigue can alert the user of when a fatigue trend is identified, such that the user does not overtrain their muscles) (see Maceachern, par 0054).
Claim(s) 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Martin as modified by Gumery and Maceachern as applied to claim 1 above, and further in view of US Patent Application Publication 20150359450 --as previously cited-- hereinafter referenced as "Lee".
With respect to claim 22, Martin in view of Gumery and in further view of Maceachern teaches the device for influencing the inspiratory muscles of a person in accordance with claim 1. Martin in view of Gumery and in further view of Maceachern fails to teach the control device is configured, during determination of the information on the muscle state for the one or more electromyographic signals, to carry out an evaluation, weighting, and summary to provide a summarized signal, wherein the summarized signal comprises parameters that are weighted more than other parameters.
Lee teaches a method, system, and computer program product storing a program for physiological signal analysis wherein the system includes a syndrome evaluation module that uses syndrome weight parameters to determine a syndrome grade of small summed intervals of the physiological signal for analysis that are output as a determination result (see Lee, par 0010-0019, 0023-0026, 0029, 0064, 0067, 0077, claim 13).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Martin in view of Gumery and in further view of Maceachern such that the control device is configured, during determination of the information on the muscle state for the one or more electromyographic signals, to carry out an evaluation, weighting, and summary to provide a summarized signal, wherein the summarized signal comprises parameters that are weighted more than other parameters because weight parameters in the evaluation of a subject/user can be used as criteria for the physiological condition analysis of the subject/user that uses the system (see Lee, par 0076).
Conclusion
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/CHARLES A MARMOR II/Supervisory Patent Examiner
Art Unit 3791
/D.J.C./ Examiner, Art Unit 3791