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 .
Claims Accounting
Applicant's arguments, filed 04/30/2026, have been fully considered.
The following rejections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Applicants have amended their claims, filed 04/30/2026, and therefore rejections newly made in the instant office action have been necessitated by amendment.
Claims 1, 10-13, 23-26, and 29 have been amended.
Claim 22 has been canceled.
Claim 43 is newly presented.
Claims 1, 10-14, 16-17, 19-20, 23-31 and 43 are the current claims hereby under examination.
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 par. [0261] of the published written description.
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 § 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, and 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over US Patent Publication 2023/0293098 by Greenberg et al. – previously cited, hereinafter “Greenberg” in view of US Patent Publication 2024/0252820 by Keenan et al., hereinafter “Keenan” – previously cited.
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); 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); and a control portion (Fig. 3, controller 104) configured to: determine a midpoint of each respiratory phase of the respiration 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 of inhalation as determined by the IMU data. This requires the determination of the respiratory phase of each respiration. Further, par. [0063] teaches that the controller may start or end stimulation at either of the zero-crossing events, meaning the midpoint of inspiration or exhalation.); identify each respiratory phase as an expiratory phase or an inspiratory phase of the respiration 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); and apply, via the electrode, the electrical stimulation based on the midpoint of an inspiratory phase (Greenberg, Fig. 6, [0063]; The electrical stimulation can be started at (b) a mid-point.). 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 or wherein the electrical stimulation is applied based on the predicted midpoint of the future inspiratory 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]). In this combination of Greenberg and Keenan, it is noted that the predicted midpoint of a future inspiratory phase is determined in order to apply the stimulation to the patient. Therefore, the electrical stimulation would be applied based on the predicted midpoint of the future inspiratory phase.
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).
Claims 10, 12, 23-25, and 43 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 a slope of each expiratory phase is positive or negative, or whether a 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 1, 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 a 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. It is further noted that the onset parameter of Greenberg teaches that the stimulation may occur as a duration that is a ratio of (i.e., percentage of) the average respiratory cycle period (i.e., respiratory rate) and may be shifted prior to the originally determined start of stimulation ([0063-0064]).
Regarding claim 25, the combination of Greenberg in view of Keenan teaches the device of claim 1, 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, and therefore the ). 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 the rejections of claims 23-24). See MPEP 2143.I.A.
Regarding claim 43, the combination of Greenberg, Keenan, and Dieken (as applied to claims 10 and 12) teaches the device of claim 1, wherein the control portion is configured to predict the midpoint of the future inspiratory phase based on at least one of a mean of the previous midpoints (Dieken, [0107-0109]; The detection of the inverted signal is based on the previous several cycles, and can be calculated by taking comparing mean of the signal. Because the processed data is based on the detection of the signal being inverted or not, the prediction of the future midpoint is based on the detection of the signal being inverted or not, which is based on the mean of the previous several cycles. The mean of the signal of the previous several cycles would include the mean of the previous midpoints of the previous several cycles.), a median of the previous midpoints, a linear extrapolation of the previous midpoints, or a non-linear extrapolation of the previous midpoints.
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 – previously cited, 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 does 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]).
Allowable Subject Matter
Claims 26-31 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter regarding claims 26 and 29:
The closest prior art is identified as the combination of Greenberg, Keenan, and Dieken, as applied to claim 1, 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 1, but does not teach wherein the control portion is configured to compute an expiratory to inspiratory half cycle as the midpoint of an inspiratory phase minus the midpoint of an immediately previous expiratory phase (claim 26) 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 (claim 29).
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]). However, the half-cycles taught by D’Mello correspond to the inhalation and exhalation of the subject. D’Mello fails to teach using the midpoints of the half cycles to compute an expiratory to inspiratory half cycle or an inspiratory to expiratory half cycle by subtracting the midpoints of the phases with the midpoints of the immediately previous phase.
Therefore, the limitations of these claims are patentably distinct over the prior art cited in this Office action and any other prior art.
Response to Arguments
Applicant’s arguments, filed 04/30/2026 have been fully considered.
The amendments to the claims overcome the rejections under 35 U.S.C. 112(b) of claims 10 and 12.
The amendments to the claims overcome the rejection under 35 U.S.C. 101.
Applicant’s assertions regarding the rejection of claim 1 under 35 U.S.C. 103 are acknowledged.
Regarding claim 1, Applicant argues that neither Greenberg or Keenan teaches starting or stopping stimulation based on a predicted midpoint of a future inspiratory phase. This argument is not persuasive. Examiner relies on Greenberg to teach applying electrical stimulation based on a midpoint of an inspiratory or expiratory phase. Fig. 6 of Greenberg teaches that stimulation may be started at the minima, mid-point (zero-crossing), or end of exhalation. The bottom plot of Fig. 8 of Greenberg depicts the waveform of the data obtained from the IMU, where the troughs are the minima (i.e., beginning of inspiration) and the following peaks are the end of inspiration ([0037]). The mid-point is defined as the mid-point between the local minimum (i.e., beginning of inspiration) and local maximum (i.e., end of inspiration) ([0063]). Therefore, this mid-point of Greenberg is the mid-point of the inspiratory phase. Keenan is not relied upon to teach predicting a future mid-point of the inspiratory phase. Rather, Keenan is relied upon to teach using previous sensor data to predict a stimulation timepoint for the next respiratory cycle (i.e., in the future). The combination of applying stimulation at the mid-point of the inspiratory cycle as taught by Greenberg and using previous sensor data to predict a future stimulation timepoint as taught by Keenan teaches the limitation of predicting a midpoint of a future inspiratory phase based on the previous midpoints of each respiratory phase.
Regarding claims 23-25, Applicant argues that neither Greenberg, Keenan, nor Dieken teaches starting or ending stimulation relative to a predicted midpoint of a future inspiratory phase. This argument is not found persuasive. As stated above, the combination of Greenberg and Keenan teach starting stimulation at a predicted midpoint of a future inspiratory phase. Dieken is relied upon to teach an onset and an offset parameter that to begin stimulation either before or after the designated stimulation point. The designated stimulation point in the combination of Greenberg and Keenan is the predicted midpoint of a future inspiratory phase. The combination of the device taught by Greenberg in view of Keenan with the onset and offset parameters taught by Dieken results in adjusting the stimulation relative to the predicted midpoint of a future inspiratory phase.
Regarding claims 26 and 29, Applicant argues that Greenberg, Keenan, Dieken, and D’Mello fails to disclose computing an inspiratory to expiratory half cycle or an expiratory to inspiratory half cycle. Applicant argues that the fitting of the sinusoidal waveform to the data and the determining of a midpoint of an initial positive half-cycle to a subsequent negative half-cycle does not read on the aforementioned claim limitations. This argument is found persuasive. While D’Mello teaches computing the midpoint of a positive half-cycle (inhalation) and a negative half-cycle (exhalation), D’Mello fails to teach computing an inspiratory to expiratory half cycle as the midpoint of an inspiratory phase minus the midpoint of an immediately previous expiratory phase or an expiratory to inspiratory half cycle as the midpoint of an inspiratory phase minus the midpoint of an immediately previous expiratory phase. Due to these limitations, claims 26 and 29 are patentably distinct over the prior art, as noted above.
By virtue of their dependency from claims 26 and 29, claims 27-28 and 30-31 are also patentably distinct over the prior art.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NELSON A GLOVER whose telephone number is (571)270-0971. The examiner can normally be reached Mon-Fri 8:00-5:00 EST.
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/NELSON ALEXANDER GLOVER/Examiner, Art Unit 3791
/ADAM J EISEMAN/Primary Examiner, Art Unit 3791
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