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 .
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 04/11/2024 (5 were submitted on this date), 09/04/2024, 11/04/2024, 10/27/2025, 10/28/2025, and 11/06/2025 have been considered by the examiner. All lined through foreign references were not considered as there were no matching references or translations provided. Applicant should note that the large number of references in the attached IDSs have been considered by the examiner in the same manner as other documents in Office search files are considered by the examiner while conducting a search of the prior art in a proper field of search.
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
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 limitations are:
• “control portion” first recited in claim 1.
Because these claim limitations are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, they are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
The corresponding structure for “control portion” is identified as a controller and a memory as described in [0261].
If applicant does not intend to have these limitations 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 10-13 and 22-31 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.
Regarding claim 10, the claim recites the limitation “the slope of each expiratory phase” in line 2. There is insufficient antecedent basis for this limitation.
For the purposes of examination, the claim is interpreted as “a slope of each expiratory phase”.
Regarding claim 12, the claim recites the limitation “the slope of each inspiratory phase” in line 2. There is insufficient antecedent basis for this limitation.
For the purposes of examination, the claim is interpreted as “a slope of each inspiratory phase”.
Regarding claim 22, the claim recites “wherein the control portion is configured to apply the electrical stimulation” in line 4. It is unclear how the control portion is capable of applying an electrical stimulation. The control portion is interpreted as a controller and a memory (see Claim Interpretation section above), and it is unclear how a controller and a memory is capable of applying an electrical stimulation to an upper airway. Clarification is requested.
For the purposes of examination, the claim is interpreted as “wherein the control portion is configured to instruct the electrode to apply the electrical stimulation”.
All claims not explicitly addressed above are rejected under 35 U.S.C. 112(b) are rejected by virtue of their dependency on a rejected base claim.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1, 10-14, 17, and 19-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) as a whole, considering all claim elements both individually and in combination, do not amount to significantly more than an abstract idea. A streamlined analysis of claim 1 follows.
Step 1
Regarding claim 1, the claim recites a device configured to perform series of steps or acts, including predicting a midpoint of a future inspiratory phase based on previous midpoints of each respiratory phase. Thus, the claim is directed to a machine, which is one of the statutory categories of invention.
Step 2A, Prong One
The claim is then analyzed to determine whether it is directed to any judicial exception. The step of predicting a midpoint of a future inspiratory phase based on previous midpoints of each respiratory phase sets forth a judicial exception. This step describes the use of mathematical relationships, mathematical formulas or equations, and/or mathematical calculations. This step also describes a concept performed in the human mind (including an observation, evaluation, judgment, opinion). Thus, the claim is drawn to a Mathematical Concept and/or Mental Process, which are Abstract Ideas.
Step 2A, Prong Two
Next, the claim as a whole is analyzed to determine whether the claim recites additional elements that integrate the judicial exception into a practical application. The claim fails to recite an additional element or a combination of additional elements to apply, rely on, or use the judicial exception in a manner that imposes a meaningful limitation on the judicial exception.
The predicting of a midpoint of a future inspiratory phase does not provide an improvement to the technological field as the functional limitation does not effect a particular treatment or effect a particular change based on the predicted midpoint, nor does the method use a particular machine to perform the Abstract Idea. Claim 1 recites the additional limitations of a sensor securable to a patient to provide a sensor signal, the sensor to sense changes in acceleration indicative of respiration of a patient, and a control portion configured to carry out the functional limitations. Each of these components are generic components recited at a high level of generality that do not amount to a particular machine.
Step 2B
Next, the claim as a whole is analyzed to determine whether any element, or combination of elements, is sufficient to ensure that the claim amounts to significantly more than the exception. Besides the Abstract Idea, the claim recites the additional limitations of a sensor securable to a patient to provide a sensor signal, the sensor to sense changes in acceleration indicative of respiration of a patient, and a control portion configured to carry out the functional limitations. The recited sensor is a generic sensor capable of sensing acceleration. Any accelerometer placed on or in a patient can sense changes in acceleration indicative of respiration. Besides the Abstract Idea, the controller is further configured to perform the additional steps of determining a midpoint of each respiratory phase and identify each expiratory or inspiratory phase. Determining the midpoint of respiratory phases and identifying inspiratory and expiratory phases of respiration are well-understood, routine and conventional activity for those in the field of medical diagnostics. Further, the determining and identifying steps are each recited at a high level of generality such that it amounts to insignificant presolution activity, e.g., mere data gathering step necessary to perform the Abstract Idea. When recited at this high level of generality, there is no meaningful limitation, such as a particular or unconventional step that distinguishes it from well-understood, routine, and conventional data gathering and comparing activity engaged in by medical professionals prior to Applicant's invention. Furthermore, it is well established that the mere physical or tangible nature of additional elements such as the sensor and control unit do not automatically confer eligibility on a claim directed to an abstract idea (see, e.g., Alice Corp. v. CLS Bank Int'l, 134 S.Ct. 2347, 2358-59 (2014)).
Consideration of the additional elements as a combination also adds no other meaningful limitations to the exception not already present when the elements are considered separately. Unlike the eligible claim in Diehr in which the elements limiting the exception are individually conventional, but taken together act in concert to improve a technical field, the claim here does not provide an improvement to the technical field. Even when viewed as a combination, the additional elements fail to transform the exception into a patent-eligible application of that exception. Thus, the claim as a whole does not amount to significantly more than the exception itself. The claim is therefore drawn to non-statutory subject matter.
The dependent claims 10-14, 16-17, and 19-20 also fail to add something more to the abstract independent claims as they generally recite method steps pertaining to data gathering and details of the generic sensor. The predicting step recited in the independent claim maintains a high level of generality even when considered in combination with the dependent claims.
It is noted that dependent claim 22, and the claims that depend therefrom are not rejected under 35 U.S.C. 101 as the electrode is configured to apply an electrical stimulation, which would effect a particular treatment or effect a particular change based on the predicted midpoint.
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 1, 14, 16-17, 19-20 and 22, are rejected under 35 U.S.C. 103 as being unpatentable over US Patent Publication 2023/0293098 by Greenberg et al. – cited by Applicant, hereinafter “Greenberg” in view of US Patent Publication 2024/0252820 by Keenan et al., hereinafter “Keenan”.
Regarding claim 1, Greenberg teaches a device (Fig. 1, system 100) comprising: a sensor securable to a patient to provide a sensor signal (Fig. 1, IMU 102), the sensor to sense changes in acceleration indicative of respiration of the patient ([0042]; IMU 102 comprises an accelerometer and/or gyroscope to detect movement indicative of respiration); and a control portion (Fig. 3, controller 104) configured to: determine a midpoint of each respiratory phase of the patient based on the sensor signal ([0046, 0063]; The system 100 is configured to deliver stimulation via electrode 112. The system may deliver the stimulation at a mid-point of the local minimum and maximum as determined by the IMU data); identify each expiratory phase or each inspiratory phase of the patient based on the sensor signal ([0013, 0063]; The controller may accurately determine the starting and ending points of inspiration and exhalation to determine when to apply stimulation). Greenberg does not teach wherein the controller is configured to predict a midpoint of a future inspiratory phase based on previous midpoints of each respiratory phase.
Keenan teaches a system to provide stimulation to a patient to prevent an upper airway obstruction. Keenan teaches that it is advantageous to predict the future time of stimulation, as relying on processed respiratory sensor data is subject to delays resulting from the sensor used, the mechanical effects of respiration, and digital filter group delay. Keenan teaches a method of using the knowledge of the previous respiratory data to predict the stimulation timepoint for the next inspiratory cycle ([0055]).
It would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to have modified the controller of the device of Greenberg to predict a midpoint of a future inspiratory phase based on previous midpoints of each respiratory phase, in order to avoid delays resulting from processing the respiratory data, as taught by Keenan ([0055]).
Regarding claim 14, Greenberg in view of Keenan teaches the device of claim 1, wherein the sensor comprises an accelerometer (Greenberg, IMU 102 comprises an accelerometer) to sense rotational movement (Greenberg, Fig. 5; the accelerometer data is used to calculate roll and pitch angles (i.e., rotational movement)).
Regarding claim 16, Greenberg in view of Keenan teaches the device of claim 14, wherein the accelerometer comprises a three axis accelerometer (Greenberg; [0016]; “the accelerometer comprises a 3-axis accelerometer”).
Regarding claim 17, Greenberg in view of Keenan teaches the device of claim 16, wherein the three axis accelerometer provides three respective sensor signals (Greenberg; Fig. 4, Ax, Ay, and Az are the three respective sensor signals), and wherein the control portion is configured to: determine a confidence factor associated with each of the three respective sensor signals; identify which respective sensor signal exhibits the greatest confidence factor; and determine the midpoint of each respiratory phase of the patient based on the identified sensor signal exhibiting the greatest confidence factor (Greenberg; [0023]; In some aspects, the accelerometer is a 3-axis accelerometer and the controller is configured to determine whether the SNR of at least two out of the three axes of the accelerometer are above a predetermined threshold and to use the strongest component signal to determine the respiratory cycle of the subject.).
Regarding claims 19-20, Greenberg in view of Keenan teaches the device of claim 1, further comprising: a filter configured to filter the sensor signal (Greenberg; [0018]; Data generated by the sensor may be filtered) such that zero crossings of the sensor signal indicate the midpoints of each respiratory phase (Greenberg; [0063]; The midpoint is defined as a “zero-crossing event”), and wherein the filter comprises a bandpass filter (Greenberg; [0018]; The filter may comprise a bandpass filter).
Regarding claim 22, Greenberg in view of Keenan teaches the device of claim 1, further comprising: an electrode to deliver electrical stimulation to an upper airway patency-related nerve of the patient (Greenberg, [0043]; electrode 112 is used to stimulate a respiratory system. The electrode capable of stimulating any nerve it delivers stimulation to, including an upper airway patency-related nerve of the patient), wherein the control portion is configured to apply the electrical stimulation based on the predicted midpoint of the future inspiratory phase (Greenberg, Fig. 6, [0063]; The electrical stimulation can be started at (b) a mid-point. In the combination of Greenberg and Keenan, this mid-point is a future midpoint).
Claims 10 and 12, and 23-25 are rejected under 35 U.S.C. 103 as being unpatentable over Greenberg in view of Keenan, as applied to claim 1, in view of US Patent Publication 2019/0160282 by Dieken et al., hereinafter “Dieken”.
Regarding claims 10 and 12, Greenberg in view of Keenan teaches the device of claim 1, but does not teach wherein the control portion is configured to identify whether the slope of each expiratory phase is positive or negative, or whether the slope of each inspiratory phase is positive or negative.
Dieken teaches a method of determining a change in posture of an individual wherein a respiration signal of the individual is measured by an accelerometer. The respiration signal can be inverted with due to posture changes, with the inversion being determined by inspiration as having a predominantly negative slope and expiration having a predominantly positive slope. The slope of the waveform may be observable over several cycles, and can be calculated by taking comparing mean of the signal to a midpoint value ([0107-0109]). Detecting an inverted signal may ensure that accurate tracking of patient respiration occurs ([0109]).
It would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to have modified the device taught by Greenberg in view of Keenan such that the control portion is configured to identify whether the slope of each expiratory phase is positive or negative, and whether the slope of each inspiratory phase is positive or negative, in order to determine if the respiration signal is inverted and ensure accurate tracking of patient respiration, as taught by Dieken ([0109]).
Regarding claims 23-24, Greenberg in view of Keenan teaches the device of claim 22, but does not teach wherein the control portion is configured to apply the electrical stimulation starting relative to the predicted midpoint by a first predetermined interval and ending after the predicted midpoint by a second predetermined interval; or wherein the control portion is configured to apply the electrical stimulation starting an amount of time prior to the predicted midpoint computed as a percentage of a respiratory rate and ending after the predicted midpoint.
Dieken teaches a stimulation manager that includes aa stimulation onset and/or offset parameter. Dieken teaches that the onset and offset parameter may be applied such that the stimulation begins before a designated point by the onset parameter (i.e., a first predetermined interval) and that stimulation ends a fixed time after the designated point (i.e., a second predetermined interval). The onset and offset parameters can be set relative to the same designated time point, or different time points ([0211, 0215]).
It would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to have modified the device of Greenberg in view of Keenan such that the control portion is configured to apply the electrical stimulation starting relative to the predicted midpoint by a first predetermined interval and ending after the predicted midpoint by a second predetermined interval, or wherein the control portion is configured to apply the electrical stimulation starting an amount of time prior to the predicted midpoint computed as a percentage of a respiratory rate and ending after the predicted midpoint, as taught by Dieken. This modification merely comprises a simple substitution of one known element (stimulation schedule of Greenberg) for another (stimulation schedule with onset and offset parameters of Dieken) to obtain predictable results. See MPEP 2143.I.B.
It is noted that par. [0064] of Greenberg teaches that it is contemplated that additional stimulation schedules are possible and compatible with the present systems and methods. In the combination, the designated point in which the onset and offset parameters are applied relative to is the mid-point of Greenberg.
Regarding claim 25, the combination of Greenberg in view of Keenan teaches the device of claim 22, wherein the control portion is configured to apply the electrical stimulation starting an amount of time prior to the predicted midpoint computed as a percentage of a respiratory rate plus and ending after the predicted midpoint (Greenberg, [0064]; the stimulation may occur as a duration that is a ratio of (i.e., percentage of) the average respiratory cycle period.). Greenberg in view of Keenan does not teach the amount of time prior to the predicted midpoint including a predetermined amount of time.
It would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to have modified the device taught by Greenberg in view of Keenan to include a predetermined amount of time, as taught by Dieken (i.e., onset parameter). This modification comprises combining known prior art elements to yield predictable results. See MPEP 2143.I.A.
Claims 11 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Greenberg in view of Keenan in view of Dieken, as applied to claims 10 and 12, in view of US Patent Publication 2015/0258290 by Landwehr, hereinafter “Landwehr”.
Regarding claim 11, the combination of Greenberg, Keenan, and Dieken teaches the device of claim 10, wherein the control portion is configured to: determine a value indicative of data points of the sensor signal between a current midpoint and at least two previous midpoints (Dieken, [0108]; the presence of an inverted signal can be determined over several past respiratory cycles (i.e., including at least two previous midpoints) by taking the mean (i.e., value indicative of the data points) of the signal over that time and comparing it to a midpoint value); identify the slope of the expiratory phase as negative in response to the value indicative of the data points being less than 0; and identify the slope of the expiratory phase as positive in response to the value indicative of the data points being greater than 0 (Greenberg; the midpoint value is a zero-crossing, therefore in the combination, the mean is compared to zero. Dieken, [0108] the expiratory phase of an inverted signal has a positive slope. The signal is considered inverted if the mean of the signal is greater than the midpoint value (i.e., zero). Therefore, if the mean is greater than the midpoint, the expiratory phase has a positive slope (inverted signal), and if the means is less than the midpoint, the expiratory phase has a negative slope (not an inverted signal)). The combination of Greenberg, Keenan, and Dieken do not teach the value indicative of the data points being a median.
Landwehr teaches a method of monitoring respiration data from a patient for abnormalities in breathing. Landwehr teaches using the median of the respiratory data over a preset time instead of the mean because the median is robust against outlier values ([0019]).
It would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to have modified the device taught by the combination of Greenberg, Keenan, and Dieken such the determination of the slope uses the median instead of a mean, in order to be more robust against outliers, as taught by Landwehr ([0019]).
Regarding claim 13, the combination of Greenberg, Keenan, and Dieken teaches the device of claim 12, wherein the control portion is configured to: determine a value indicative of data points of the sensor signal between a current midpoint and at least two previous midpoints (Dieken, [0108]; the presence of an inverted signal can be determined over several past respiratory cycles (i.e., including at least two previous midpoints) by taking the mean (i.e., value indicative of the data points) of the signal over that time and comparing it to a midpoint value); identify the slope of the inspiratory phase as negative in response to the value indicative of the data points being less than 0; and identify the slope of the expiratory phase as positive in response to the value indicative of the data points being greater than 0 (Greenberg; the midpoint value is a zero-crossing, therefore in the combination, the mean is compared to zero. Dieken, [0108] the inspiratory phase of an inverted signal has a negative slope. The signal is considered inverted if the mean of the signal is greater than the midpoint value (i.e., zero). Therefore, if the mean is greater than the midpoint, the inspiratory phase has a negative slope (inverted signal), and if the means is less than the midpoint, the inspiratory phase has a positive slope (not an inverted signal)). The combination of Greenberg, Keenan, and Dieken do not teach the value indicative of the data points being a median.
Landwehr teaches a method of monitoring respiration data from a patient for abnormalities in breathing. Landwehr teaches using the median of the respiratory data over a preset time instead of the mean because the median is robust against outlier values ([0019]).
It would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to have modified the device taught by the combination of Greenberg, Keenan, and Dieken such the determination of the slope uses the median instead of a mean, in order to be more robust against outliers, as taught by Landwehr ([0019]).
Claims 26 and 29 are rejected under 35 U.S.C. 103 as being unpatentable over Greenberg in view of Keenan in view of Dieken, as applied to claim 22, in view of US Patent Publication 2021/0315463 by D’Mello et al., hereinafter “D’Mello”.
The combination of Greenberg, Keenan, and Dieken teaches the device of claim 22, but does not teach wherein the control portion is to compute an expiratory to inspiratory half cycle as the midpoint of an inspiratory phase minus the midpoint of an immediately previous expiratory phase or to compute an inspiratory to expiratory half cycle as the midpoint of an expiratory phase minus the midpoint of an immediately previous inspiratory phase.
D’Mello teaches a cycle isolator that computes an initial positive half-cycle and a subsequent negative half cycle. The positive half cycle is calculated by subtracting the zero-crossing (i.e., midpoint) of an inspiratory phase minus the zero-crossing of an expiratory phase. The negative half cycle is calculated by subtracting the zero-crossing of an expiratory phase minus the zero-crossing of an inspiratory phase. The half cycles can be used to determine the inspiration and/or expiration phases of respiration ([0170]).
It would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to have modified the device taught by the combination of Greenberg, Keenan, and Dieken such that the control unit is to compute an expiratory to inspiratory half cycle as the midpoint of an inspiratory phase minus the midpoint of an immediately previous expiratory phase or to compute an inspiratory to expiratory half cycle as the midpoint of an expiratory phase minus the midpoint of an immediately previous inspiratory phase, in order to determine the inspiration and/or expiration phases of respiration ([0170]).
Claims 27-28 and 30-31 are rejected under 35 U.S.C. 103 as being unpatentable over Greenberg in view of Keenan in view of Dieken in view of D’Mello, as applied to claims 26 and 29, in view of US Patent Publication 2019/0009093 by Ni et al. – cited by Applicant, hereinafter “Ni”.
Regarding claim 27, the combination of Greenberg, Keenan, Dieken, and D’Mello teaches the device of claim 26, wherein the control portion is to apply the electrical stimulation starting an amount of time prior to the predicted midpoint (Dieken, onset parameter) and ending after the predicted midpoint (offset parameter), but does not teach that the amount of time is computed as a percentage of the expiratory to inspiratory half cycle.
Fig. 5B of Ni teaches a method of applying electrical stimulation to a patient during a specific portion of the respiratory cycle, relative to the zero-crossing points (beginning/end of inspiration and expiration). Ni teaches that the stimulation begins before the midpoint and ends after the midpoint. The stimulation can begin prior to the midpoint by a designated percentage of the inspiratory phase (this can be considered the expiratory to inspiratory half cycle) ([0066, 0069]).
It would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to have modified the device taught by the combination of Greenberg, Keenan, Dieken, and D’Mello such that the control portion is configured to apply the electrical stimulation starting an amount of time prior to the predicted midpoint computed as a percentage of the expiratory to inspiratory half cycle, as taught by Ni. This modification comprises the use of a known technique (stimulation schedule based on the respiratory cycle as taught by Ni) to improve similar devices (The device taught by the combination of Greenberg, Keenan, Dieken, and D’Mello) in the same way. See MPEP 2143.I.C.
It is reiterated that par. [0064] of Greenberg teaches that it is contemplated that additional stimulation schedules are possible and compatible with the present systems and methods. In the combination, the designated point in which the onset and offset parameters are applied relative to is the mid-point of Greenberg.
Regarding claim 28, the combination of Greenberg, Keenan, Dieken, and D’Mello, teaches the device of claim 26, wherein the control portion is to apply the electrical stimulation starting prior to the predicted midpoint (Dieken, onset parameter) and ending after the predicted midpoint by an amount of time (Dieken, offset parameter), but does not teach wherein the amount of time is computed as a percentage of the expiratory to inspiratory half cycle.
Fig. 5B of Ni teaches a method of applying electrical stimulation to a patient, wherein the stimulation begins before the midpoint and ends after the midpoint. The stimulation can end after the midpoint by a designated percentage of the expiratory phase (this can be considered the expiratory to inspiratory half cycle) ([0067, 0070]).
It would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to have modified the device taught by the combination of Greenberg, Keenan, Dieken, and D’Mello such that the control portion is configured such that the application of the electrical stimulation ends after the predicted midpoint by an amount of time computed as a percentage of the expiratory to inspiratory half cycle, as taught by Ni. This modification comprises the use of a known technique (stimulation schedule based on the respiratory cycle as taught by Ni) to improve similar devices (The device taught by the combination of Greenberg, Keenan, Dieken, and D’Mello) in the same way. See MPEP 2143.I.C.
Regarding claim 30, the combination of Greenberg, Keenan, Dieken, and D’Mello teaches the device of claim 29, wherein the control portion is configured to apply the electrical stimulation starting an amount of time prior to the predicted midpoint (Dieken, onset parameter), and ending after the predicted midpoint (Dieken, offset parameter) but does not teach the amount of time computed as a percentage of the inspiratory to expiratory half cycle.
Fig. 5B of Ni teaches a method of applying electrical stimulation to a patient, wherein the stimulation begins before the midpoint and ends after the midpoint. The stimulation can begin prior to the midpoint by a designated percentage of the inspiratory phase (this can be considered the inspiratory to expiratory half cycle) ([0066, 0069]).
It would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to have modified the device taught by the combination of Greenberg, Keenan, Dieken, and D’Mello such that the control portion is configured to apply the electrical stimulation starting an amount of time prior to the predicted midpoint computed as a percentage of the inspiratory to expiratory half cycle, as taught by Ni. This modification comprises the use of a known technique (stimulation schedule based on the respiratory cycle as taught by Ni) to improve similar devices (The device taught by the combination of Greenberg, Keenan, Dieken, and D’Mello) in the same way. See MPEP 2143.I.C.
Regarding claim 31, the combination of Greenberg, Keenan, Dieken, and D’Mello teaches the device of claim 29, wherein the control portion is configured to apply the electrical stimulation starting prior to the predicted midpoint (Dieken; onset parameter) and ending after the predicted midpoint by an amount of time (Dieken; offset parameter), but does not teach the amount of time computed as a percentage of the inspiratory to expiratory half cycle.
Fig. 5B of Ni teaches a method of applying electrical stimulation to a patient, wherein the stimulation begins before the midpoint and ends after the midpoint. The stimulation can end after the midpoint by a designated percentage of the expiratory phase (this can be considered the inspiratory to expiratory half cycle) ([0067, 0070]).
It would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to have modified the device taught by the combination of Greenberg, Keenan, Dieken, and D’Mello such that the control portion is configured such that the application of the electrical stimulation ends after the predicted midpoint by an amount of time computed as a percentage of the inspiratory to expiratory half cycle, as taught by Ni. This modification comprises the use of a known technique (stimulation schedule based on the respiratory cycle as taught by Ni) to improve similar devices (The device taught by the combination of Greenberg, Keenan, Dieken, and D’Mello) in the same way. See MPEP 2143.I.C.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US Patent Publication 2012/0302900 by Yin et al. teaches an apparatus comprising a multi-axial accelerometer configured to measure physiological signals representative of respiration.
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/NELSON ALEXANDER GLOVER/Examiner, Art Unit 3791
/ADAM J EISEMAN/Primary Examiner, Art Unit 3791