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 .
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1, 6, 13, and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over “A New Ultrasound Method for Estimating Dynamic Intrinsic Positive Airway Pressure: A Prospective Clinical Trial” (hereinafter “Bernardi”) in view of Blanch (US 20050284476) further in view of Mulqueeny (US 20080110461).
1. Bernardi discloses a respiration monitoring device used to perform a respiration monitoring method including: receiving ultrasound imaging data of a diaphragm of a patient as a function of time during inspiration and expiration (p. 394, left column, hypercapnic patients underwent ultrasonography visualizing the diaphragm; the patients are on mechanical ventilation connected to a mouthpiece, with the ultrasound sensing hyperechoic divergence of lines during inspiration and a granular pattern at the diaphragm-liver interface ending expiration) while the patient undergoes mechanical ventilation therapy with a mechanical ventilator (see p. 392, right column, the patient is on spontaneous or assisted mechanical ventilation, with treatment inclusive of external PEEP; see also Table 1); receiving respiratory data of the patient as a function of time during the inspiration and expiration while the patient undergoes the mechanical ventilation therapy, the respiratory data comprising a ventilator flow waveform (see p. 394, left paragraph, airflow is recorded while the mechanically ventilated patient is connected to a mouthpiece, thus creating the flow traces of inspiration and expiration; note also table 1, patients on PS are managed via the inspiration/expiration data; the air flow value determined from the waveform is the onset of inspiratory flow, see p. 394, right paragraph); and calculating an intrinsic positive end-expiratory pressure (iPEEP) value for the patient based on the ultrasound imaging data (see 394, right column).
Bernardi discloses detecting an onset of inspiratory effort by the patient based on the ultrasound imaging data (see p. 394, right column). However, Bernardi does not disclose at least one electronic processor programmed to perform a respiration monitoring method, wherein the respiratory data comprises a corresponding air flow value determined from the ventilator flow waveform; wherein the iPEEP value for the patient is based on the corresponding air flow value determined from the ventilator flow waveform, identified using the ultrasound imaging data. Nonetheless, Blanch discloses a respiration monitoring device, comprising at least one electronic processor programmed to perform a respiration monitoring method (see [0037]), wherein respiratory data comprises a corresponding air flow value determined from the ventilator flow waveform (flow at inspiratory effort onset per [0070] is determined from the flow waveform per [0056], Fig. 3); and calculating an iPEEP value for the patient based on detecting an inspiratory effort onset by the patient and the corresponding air flow value determined from the ventilator flow waveform, identified using the inspiratory effort onset data (see [0007, 0023, 0069-0071], where esophageal balloon measurement is the gold standard for detecting inspiratory effort onset as discussed in Bernardi). Therefore, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to modify ultrasound inspiratory onset data of Bernardi to derive the additional iPEEP calculation as taught in Blanch, as such calculation is understood to provide the predictable result of an iPEEP measurement because if gas is still flowing out of the lungs at the onset of inhalation, it can be reasoned that the only force driving this gas flow, at this instant in time, is iPEEP. It is noted that the additional iPEEP calculation may provide another marker for detecting, quantifying, and verifying the iPEEP value, see [0015] in Blanch, and may do so using inspiratory onset data that is derived non-invasively.
However, Bernardi does not disclose wherein the method further includes: determining an adjustment of at least one mechanical ventilation setting of the mechanical ventilator based on the calculated iPEEP value; and one of: (i) applying the determined adjustment to the mechanical ventilator or (ii) displaying, on the display device, the determined adjustment as a proposed adjustment. Bernardi does disclose it is important to set the external PEEP correctly during MV to reduce the inspiratory effort required to trigger the ventilator and to avoid further hyperinflation, see c. 392, right column. Mulqueeny discloses wherein the method further includes: determining an adjustment of at least one mechanical ventilation setting of the mechanical ventilator based on the calculated iPEEP value; and one of: (i) applying the determined adjustment to the mechanical ventilator or (ii) displaying, on the display device, the determined adjustment as a proposed adjustment (see [0018], [0020], ventilator applied external PEEP is set to offset PEEPi dependent upon the PEEPi level). Therefore, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to modify the method and processor of Bernardi in view of Blanch according to the offset external PEEP of Mulqueeny in order to reduce the magnitude of negative deflection in pleural pressure required to trigger the ventilator, and since Bernardi already measures PEEPi on a breath-to-breath basis using the applied ultrasound in both spontaneous and assisted breathing.
6. Bernardi as modified by Blanch discloses the device of claim 1, wherein calculating the iPEEP value comprises: detecting an onset of inspiratory effort by the patient based on the ultrasound imaging data (see Bernardi, p. 394, right column), wherein Blanch discloses determining the corresponding air flow value from the lungs of the patient at the detected onset of inspiratory effort by the patient from the ventilator flow waveform (see Blanch, [0007, 0069-0071], where esophageal balloon measurement is the gold standard of inspiration onset as discussed in Bernardi); and calculating the iPEEP value based on the corresponding air flow value from the lungs of the patient at the detected onset of inspiratory effort by the patient (see equation in paragraph [0070]).
13. Bernardi as modified by Mulqueeny discloses the device of claim 1, wherein the determined adjustment includes one of: a change in an exhalation time; and a change in a pressure applied by the mechanical ventilator during exhalation (see [0018], external PEEP).
15. Bernardi as modified by Blanch and Mulqueeny discloses a respiration monitoring method comprising, with an electronic controller: receiving ultrasound imaging data of a diaphragm of a patient as a function of time during inspiration and expiration while the patient undergoes mechanical ventilation therapy with a mechanical ventilator; receiving respiratory data of the patient as a function of time during the inspiration and expiration while the patient undergoes the mechanical ventilation therapy, the respiratory data comprising a corresponding air flow value determined from a ventilator flow waveform; calculating a intrinsic positive end-expiratory pressure (PEEP) value for the patient based on the ultrasound imaging data and the corresponding air flow value determined from the ventilator flow waveform, identified using the ultrasound imaging data; determining an adjustment of at least one mechanical ventilation setting of the mechanical ventilator based on the calculated iPEEP value; and one of: (i) applying the determined adjustment to the mechanical ventilator or (ii) displaying, on a display device, the determined adjustment as a proposed adjustment (see claim 1 above).
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bernardi in view of Blanch in view of Mulqueeny in view of Angelico (US 20140034054).
7. Bernardi discloses the device of claim 6, but does not disclose wherein the method further includes: triggering the mechanical ventilator to initiate a breath based on the determined onset of inspiratory effort by the patient. Angelico discloses triggering the mechanical ventilator to initiate a breath based on the determined onset of inspiratory effort by the patient (see [0084 – 0087, where examiner notes that the Edi signal would correspond to the ultrasound signal in Bernardi). Therefore, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to modify the method of Bernardi in view of Blanch according to inspiratory onset triggering as taught in Angelico for the benefit of near instantaneous coupling between the ventilator and the patient’s diaphragm.
Claim(s) 2 – 5 and 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bernardi in view of Blanch in view of Mulqueeny in view of “Diaphragm ultrasound as indicator of respiratory effort in critically ill patients undergoing assisted mechanical ventilation: a pilot clinical study” (hereinafter “Umbrello”).
2. Bernardi discloses the device of claim 1, wherein the method further includes: determining a diaphragm activity as a function of time based on the received ultrasound imaging data of the diaphragm of the patient, including a divergence in hyperechoic lines; wherein the iPEEP value is calculated based on the diaphragm activity as a function of time and the respiratory data (see p. 394, Bernardi; as discussed in claim 1 above, Blanch uses an inspiratory onset effort to identify the airflow value, and Bernardi uses an ultrasound diaphragm metric to identify inspiratory onset in the calculation of iPEEP). However, Bernardi does not disclose determining a diaphragm thickness metric as a function of time based on the received ultrasound imaging data of the diaphragm of the patient; wherein the iPEEP value is calculated based on the diaphragm thickness metric as a function of time and the respiratory data. Nonetheless, Umbrello discloses determining a diaphragm thickness metric as a function of time based on the received ultrasound imaging data of the diaphragm of the patient, the diaphragm thickness metric to identify the onset of inspiratory effort (see p. 1, “conclusions”; p. 2, para 2; p. 3, end of column 1; “key messages”, p. 9, Fig. 1). Therefore, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to modify the ultrasound imaging data used to determine inspiratory onset effort in Bernardi in view of Blanch based off the diaphragm thickness data as taught in Umbrello since thickening during active breathing reflects the magnitude of diaphragmatic effort and is the predictable result of divergence in hyperechoic lines. Upon providing the modification, the iPEEP value taught in Bernardi in view of Blanch is calculated based on the diaphragm thickness metric as a function of time and the respiratory data, as taught in Umbrello.
3. Bernardi as modified by Blanch and Umbrello discloses the device of claim 2, wherein the calculating of the iPEEP value includes: identifying a time corresponding to start of inhalation based on the determined diaphragm thickness metric (see Umbrello, p. 3, end of column 1); and calculating the iPEEP value at the identified time corresponding to start of inhalation (upon providing the modification, the iPEEP value taught in Bernardi in view of Blanch is calculated based on ultrasound derived inspiratory onset effort, and the corresponding airflow value is identified using the diaphragm thickness metric to identify the onset of inspiratory effort as taught in Umbrello).
4. Bernardi discloses the device of claim 2, wherein the calculating of the iPEEP value includes: identifying a time corresponding to start of inhalation based on the received respiratory data; and calculating the iPEEP value at the identified time corresponding to start of inhalation (see Bernard, p. 394, right column, where the latency time is measured according to the onset of inspiratory flow).
5. Bernardi discloses the device of claim 3, but does not disclose wherein the iPEEP value is calculated as iPEEP=−R{dot over (V)}(t) where R is a respiratory resistance of lungs of the patient and {dot over (V)}(t) is the corresponding airflow value at the identified time corresponding to start of inhalation which is part of the received respiratory data of the patient. Nonetheless, Blanch discloses wherein the iPEEP value is calculated as iPEEP=−R{dot over (V)}(t) where R is a respiratory resistance of lungs of the patient and {dot over (V)}(t) is an airflow at the identified time corresponding to start of inhalation which is part of the received respiratory data of the patient (see [0007, 0069-0071], where esophageal balloon measurement is the gold standard of inspiration onset as discussed in Bernardi). Therefore, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to modify the iPEEP calculation in Bernardi according to that in Blanch as such calculation is understood to provide the predictable result of an iPEEP measurement because if gas is still flowing out of the lungs at the onset of inhalation, it can be reasoned that the only force driving this gas flow, at this instant in time, is iPEEP.
16. Bernardi as modified by Blanch discloses the respiratory monitoring method of claim 15, wherein the method further includes: determining a diaphragm activity as a function of time based on the received ultrasound imaging data of the diaphragm of the patient, including a divergence in hyperechoic lines; wherein the iPEEP value is calculated based on the diaphragm activity as a function of time and the respiratory data, the corresponding airflow value being identified using the diaphragm metric to identify the onset of inspiratory effort (see p. 394, Bernardi; as discussed in claim 1 above, Blanch uses an inspiratory onset effort to identify the airflow value, and Bernardi uses an ultrasound diaphragm metric to identify inspiratory onset in the calculation of iPEEP). However, Bernardi does not disclose determining a diaphragm thickness metric as a function of time based on the received ultrasound imaging data of the diaphragm of the patient; wherein the iPEEP value is calculated based on the diaphragm thickness metric as a function of time and the respiratory data; the corresponding airflow value being identified using the diaphragm thickness metric to identify the onset of inspiratory effort.. Nonetheless, Umbrello discloses determining a diaphragm thickness metric as a function of time based on the received ultrasound imaging data of the diaphragm of the patient, the diaphragm thickness metric to identify the onset of inspiratory effort (see p. 1, “conclusions”; p. 2, para 2; p. 3, end of column 1; “key messages”, p. 9, Fig. 1). Therefore, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to modify the ultrasound imaging data used to determine inspiratory onset effort in Bernardi in view of Blanch based off the diaphragm thickness data as taught in Umbrello since thickening during active breathing reflects the magnitude of diaphragmatic effort and is the predictable result of divergence in hyperechoic lines. Upon providing the modification, the iPEEP value taught in Bernardi in view of Blanch is calculated based on the diaphragm thickness metric as a function of time and the respiratory data, and the corresponding airflow value is identified using the diaphragm thickness metric to identify the onset of inspiratory effort as taught in Umbrello.
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bernardi in view of Blanch in view of Mulqueeny in view of Umbrello in view of Angelico.
8. Bernardi discloses the device of claim 1, but does not disclose wherein the method further includes: determining a diaphragmatic excursion value of the diaphragm for successive breaths based on the ultrasound imaging data as a function of time; and displaying, on the display device, an alert in response to an increase or decrease of the diaphragmatic excursion values for the successive breaths over time satisfying an alert criterion. Nonetheless, Umbrello discloses determining a diaphragmatic excursion value of the diaphragm for successive breaths based on the ultrasound imaging data as a function of time, see p. 2, left column, para 1. Therefore, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to modify the method of Bernardi to further include excursion monitoring as taught in Umbrello for the benefit of identifying patients with diaphragm dysfunction.
However, Umbrello does not disclose displaying, on the display device, an alert in response to an increase or decrease of the diaphragmatic excursion values for the successive breaths over time satisfying an alert criterion. Nonetheless, Angelico discloses displaying, on the display device, an alert in response to an increase or decrease of the values for the successive breaths over time satisfying an alert criterion, see [0164]. Therefore, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to modify the diaphragmatic monitoring of Bernardi in view of Umbrello with an accompanying alert as taught in Angelico for the benefit of notifying the patient and caregiver personnel of the diaphragm dysfunction.
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bernardi in view of Blanch in view of Mulqueeny in view of Umbrello in view of “Speckle tracking quantification of lung sliding for the diagnosis of pneumothorax: a multicentric observational study” (hereinafter “Duclos”) in view of Angelico.
9. Bernardi discloses the device of claim 2, including calculating the iPEEP value from the calculated diaphragm thickness metric. Bernardi does not disclose determining lung sliding of lungs of the patient for successive breaths based on speckle tracking performed on the ultrasound imaging data as a function of time; and displaying, on the display device, an alert in response to an increase or decrease of the lung sliding for the successive breaths over time satisfying an alert criterion. Nonetheless, Duclos discloses determining lung sliding of lungs of the patient for successive breaths based on speckle tracking performed on the ultrasound imaging data as a function of time, see “Discussion”, p. 1214, para 1. Therefore, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to modify the method of Bernardi to further include lung sliding tracking as taught in Duclos for the benefit of identifying conditions such as pneumothorax.
However, Duclos does not disclose and displaying, on the display device, an alert in response to an increase or decrease of the lung sliding for the successive breaths over time satisfying an alert criterion. Nonetheless, Angelico discloses displaying, on the display device, an alert in response to an increase or decrease of the values for the successive breaths over time satisfying an alert criterion, see [0164]. Therefore, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to modify the lung sliding monitoring of Bernardi in view of Duclos with an accompanying alert as taught in Angelico for the benefit of notifying the patient and caregiver personel of the diaphragm dysfunction.
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bernardi in view of Blanch in view of Mulqueeny in view of Hete (US 20020121278).
10. Bernardi discloses the device of claim 1, but does not disclose wherein the method further includes: determining a negative pressure value based on a respiratory effort of the patient; and in response to the calculated iPEEP value being above a threshold, determining a modified configuration of the mechanical ventilator effective to apply a negative pressure to the patient during exhalation by the patient during the mechanical ventilation therapy to assist with exhalation by the patient; and one of (i) displaying, on the display device, the determined modified configuration, or (ii) controlling the mechanical ventilator to implement the determined modified configuration. Nonetheless, Hete discloses determining a negative pressure value based on a respiratory effort of the patient (see [0050, 0052]); and in response to the calculated iPEEP value being above a threshold, determining a modified configuration of the mechanical ventilator effective to apply a negative pressure to the patient during exhalation by the patient during the mechanical ventilation therapy to assist with exhalation by the patient; and one of (i) displaying, on the display device, the determined modified configuration, or (ii) controlling the mechanical ventilator to implement the determined modified configuration (see [0050], 0052], the negative pressure is used to eliminate autoPEEP or stagnant pressure when present). Therefore, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to modify the method of Bernardi to provide negative pressure in response to iPEEP accumulation because the development of stagnation pressure creates hyperinflation exhibited by iPEEP, and reduction of the stagnation would thereby eliminate the issue.
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bernardi in view of Blanch in view of Mulqueeny in view of Souzy (US 20180256075).
14. Bernardi discloses the device of claim 1, but does not disclose further comprising: an ultrasound imaging device including an ultrasound patch attached to a portion of the patient, wherein the at least one electronic processor controls the ultrasound imaging device to receive the ultrasound imaging data of the diaphragm of the patient from the ultrasound patch; and a mechanical ventilator configured to deliver mechanical ventilation therapy to the patient. Nonetheless, Souzy discloses an ultrasound imaging device including an ultrasound patch attached to a portion of the patient, wherein the at least one electronic processor controls the ultrasound imaging device to receive the ultrasound imaging data of the diaphragm of the patient from the ultrasound patch (see [0043 – 0050, Figs. 1 and 2); and a mechanical ventilator configured to deliver mechanical ventilation therapy to the patient, see [0094 – 0100]. Therefore, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to modify the method of Bernardi according to the ultrasound patch communicating with ventilator of Souzy for the benefit of stably supporting the ultrasound along the diaphragm so as to automatically monitor and provide feedback for ventilator synchrony.
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bernardi in view of Blanch in view of Mulqueeny in view of “Diaphragmatic excursion correlates with exercise capacity and dynamic hyperinflation in COPD patients” (hereinafter “Shiraishi”).
17. Bernardi as modified discloses the respiration monitoring method of claim 15, wherein the ultrasound imaging data is used to determine iPEEP. However, Bernardi does not disclose to directly measure a cumulative effect of the iPEEP. Nonetheless, Shiraishi discloses direct measurement of diaphragmatic excursion mobility which is caused by dynamic hyperinflation (see Title, Conclusion, last paragraph of Discussion), and is thus a cumulative effect of the iPEEP (see applicant’s specification, paragraph [0042]). Examiner notes that the claims as currently written are directed to direct measurement of the effect, e.g. the excursion value, rather than the iPEEP itself. Therefore, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to modify Bernardi to measure additional values such as diaphragm excursion values as taught by Shiraishi as such measurements may indicate dynamic hyperinflation in patient’s having diseased lungs such as COPD.
Response to Arguments
Applicant's arguments filed 08/21/2026 have been fully considered but they are not persuasive.
On page 9, paragraph 2, applicant argues that Bernardi fails to disclose the corresponding air flow value determined from the ventilator flow waveform identified using ultrasound imaging data. However, the arguments fail to address Blanch, and claim 1 has been rejected over Bernardi in view of Blanch as set forth in the action above.
On page 10, paragraph 1, applicant argues that Umbrello should not be combined with Bernardi, since Umbrello states that it is unknown if his study results “can be translated to patients with intrinsic PEEP or COPD because this was an exclusion criterion”. Contrary to applicant’s assertion, the statement does not constitute a teaching away. Rather, the statement merely reflects patient selection criterion for determining the impacts of pressure support titration on diaphragm thickness as a part of Umbrello’s study protocol, see p. 6, left column, first para, p. 8, right column, third para. Bernardi discloses that diaphragm ultrasound yields two parallel hyperechoic lines that diverge during inspiration, see p. 3, para 1, and Umbrello discloses that change in diaphragm thickness is the predictable result of divergence between the echogenic layers, see p. 3, right column, para 6. One of ordinary skill in the art would have been motivated to use ultrasound diaphragm thickness to measure the ultrasound inspiratory onset effort of Bernardi in view of Blanch since thickening during active breathing reflects the magnitude of diaphragmatic effort, see Umbrello, p. 2, para 2.
Similarly, with respect to applicant’s arguments on p. 10, para 2, one of ordinary skill in the art would have been motivated to modify Bernardi in view of Blanch with Umbrello for the benefits discussed in the action above. See motivational statements in claims 1 and 2 for modifying Bernardi with Blanch, as well as modifying Bernardi and Blanch with Umbrello.
As such, examiner hereby maintains rejection of claim 1 and dependents therein.
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 BRADLEY H PHILIPS whose telephone number is (571)270-5180. The examiner can normally be reached 8:00 - 5:00 M-F.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Brandy Lee can be reached at (571) 270-7410. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRADLEY H PHILIPS/Primary Examiner, Art Unit 3799
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