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 .
Response to Amendment
This Office Action is in response to the amendments and arguments filed on 08/04/2025. Claims 1, 6 and 11 are amended. Claims 1-15 remain pending in the instant application.
Response to Arguments
Applicant's arguments filed 08/04/2025 have been fully considered but they are not persuasive.
Applicant presents arguments generally asserting that the teachings of Berthon-Jones do not teach or suggest the limitations of claim 1 regarding adjusting the base pressure based on the measure of ventilation during the apnea and particularly asserts that Berthon-Jones does not disclose the terms “measure of ventilation” and “respiratory airflow”, pulling from definitions of the glossary section of Applicant’s specification (see Pages 7-9 of Remarks).
Examiner respectfully disagrees with the presented arguments.
It is first noted that the citation of the respiratory flowrate signal of Berthon-Jones towards the limitation of “detect[ing] an apnea from the signal representative of respiratory flow rate” matches the definition provided in the glossary as cited by applicant (Applicant’s specification Paragraph 0392), and is not refuted or contended by applicant. A signal obtained from the sensor provides a respiratory flowrate signal in Berthon-Jones, which is representative of the respiratory flow rate as the signal will change according to the patient’s respiratory rate. However, while applicant points to a definition of ventilation provided in the glossary section (Paragraph 0399 of Applicant’s specification) and additionally to other ways in which ventilation may be determined (such as in Paragraphs 0392, 0399-400), the limitation “measure of ventilation” is broader than applicant may intend or asserts to be. As applicant points to, ventilation can be derived from respiratory airflow can be defined as ‘a measure of the total amount of gas being exchanged by the patient’s respiratory system’ (Page 9 of Remarks). The RMS value is similarly derived from the respiratory flowrate signal and is a moving average across a number of seconds. This value will include one or both of inspiratory and expiratory flow of the patient and is a measure of the gas being exchanged by the patient’s respiratory system. For example, a normal RMS value indicates that the patient is receiving a particular level of gas and that air is being normally exchanged in the respiratory system. A low RMS indicates that either inspiratory/expiratory flow is reduced and thus that the total amount of gas being exchanged with the patient is decreased. Furthermore, it is noted that the glossary even suggests that flow rate is usually instantaneous or on extremely short scale, whereas ventilation is measured on longer timescales (Paragraph 0400 of Applicant’s specification), which matches the relationship between instantaneous values of the respiratory flowrate signal and the RMS airflow averaged across longer timescales of Berthon-Jones. Thus, in the same regard the RMS airflow average meets the limitations as currently filed and is congruent with the definition as recited by Applicant’s specification/glossary.
Secondly, Examiner agrees that the adjustment of the set point for the base pressure is disclosed in Berthon-Jones to be based on an evaluation of the duration of the apnea. However, the RMS airflow still informs the detected duration of the apnea, or in other words, the particular values of the RMS airflow are what dictate the evaluation of the duration of the apnea and are part of the earlier causal chain/processing. Thus, the adjustment can also be said to also be based on the measure of ventilation. As presented above, the RMS values are indeed a measure of ventilation as currently recited. Berthon-Jones discloses that the prescribed pressure increase from a base pressure is determined based on the detected duration of apnea (Col. 2 lines 58 – Col. 3 line 2). Additionally, the duration of the apnea is determined by the particular values of the RMS airflow being below a threshold value for a duration (Col. 6 lines 3-12, 1-22, etc.). Thus, the prescribed increase in pressure is determined upsteam by the RMS airflow values and thus by the measure of ventilation during the apnea. In other words, though the adjustment of the set point for the base pressure is based on the previous method step of the determination of the duration of the apnea, the detected duration is contingent upon the measure of ventilation, the RMS values, during the apnea. The measure of ventilation, though more upstream and a step removed from the detected duration, still dictates the prescribed increase in pressure.
Examiner notes that a simple amendment to the claim such as a recitation that the adjustment of the set point is based primarily on the measure of ventilation during the apnea, or similar such phrasing, would distinguish over Berthon-Jones as the RMS flow is what determines the duration of the sensed apnea, and the duration is the primary measure which prescribes the adjustment of the base pressure.
Thus, all rejections are maintained and are repeated below.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-2, 6-7, 11-12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Berthon-Jones (U.S 6,367,474 B1).
Regarding claim 1, Berthon-Jones discloses an apparatus for treating a respiratory disorder in a patient (Abstract), comprising:
a pressure generator configured to supply a flow of air at positive pressure to an airway of the patient through a patient interface (see Fig. 1 and Col. 4 lines 19-31, a blower 34 pressurizes and delivers air as CPAP treatment to the patient through a mask 30);
a sensor configured to generate a signal representative of respiratory flow rate of the patient (Col. 2 lines 43-57, a flow sensor can provide a signal to determine patient respiratory airflow); and a controller (controller, Col. 2 lines 40-54) configured to:
control the pressure generator to provide ventilation therapy to the patient, the ventilation therapy having a base pressure (see Col. 2 lines 48 - Col. 3 line 4; The pressure generator is controlled to provide a first initial treatment pressure of 4 cmH2O),
detect an apnea from the signal representative of respiratory flow rate (Col. 2 lines 48-61, an apnea is detected based on the airflow signal being a reduction to below a threshold value, such as 25% of the RMS airflow over the past 5 minutes of normal breathing),
compute a measure of ventilation of the patient from the signal representative of respiratory flow rate (Col. 2 line 40 - Col. 3 lines 4, the sensor provides a measure of respiratory flow, and the patient’s flow rate is compared to a computed RMS for the past 5 minutes to determine when an apnea is present as a drop in flow below a proportion of the RMS); and
adjust a set point for the base pressure of the ventilation therapy in response to the apnea based the measure of ventilation during the apnea (Col. 2 line 58 - Col. 3 line 4, Col. 5 line 55 - Col. 6 line 46; The pressure is incremented from a set base point of 4 cmH2O that is an increasing function of the apnea duration when it increases above 10 seconds, up to a maximum pressure increase of 8 cmH2O per minute of apnea; Thus, the longer the ventilation remains below the 25% RMS threshold during the apnea, the greater the increase of pressure to a set point from the base pressure).
Regarding claim 2, Berthon-Jones discloses the device of claim 1.
Berthon-Jones further discloses wherein the adjusting the set point for the base pressure of the ventilation therapy in response to the apnea comprises: computing an effective duration of the apnea dependent on the measure of ventilation during the apnea (Col. 2 line 58 - Col. 3 line 4, Col. 5 line 55 - Col. 6 line 46; A 2 second RMS airflow during the apnea is compared to a longterm average RMS over the past 5 minutes, and if the 2 second RMS airflow is less than 25% of longterm average RMS, then the apnea duration is increased; The effective duration is based on the average RMS for the past two seconds and thus is not an absolute duration and is instead an effective duration), and adjusting the set point for the base pressure based on the effective duration of the apnea (Col. 2 line 58 - Col. 3 line 4, Col. 5 line 55 - Col. 6 line 46, the pressure is incremented the longer the apnea lasts above 10 seconds).
Regarding claim 6, Berthon-Jones discloses a method for respiratory apparatus that is configured for treating a respiratory disorder in a patient (Abstract), the method comprising:
controlling, with a ventilator, a ventilation therapy to the patient through a patient interface, the ventilation therapy having a base pressure (see Fig. 1 and Col. 4 lines 19-31, a blower 34 pressurizes and delivers air as CPAP treatment to the patient through a mask 30; see Col. 2 lines 48 - Col. 3 line 4; The pressure generator is controlled by a controller to provide a first initial treatment pressure of 4 cmH2O),
detecting, in a controller of the ventilator, an apnea from a sensor signal representative of respiratory flow rate of the patient (Col. 2 lines 43-57, a flow sensor can provide a signal to a controller to determine patient respiratory airflow; Col. 2 lines 48-61, an apnea is detected based on the airflow signal being a reduction to below a threshold value, such as 25% of the RMS airflow over the past 5 minutes of normal breathing),
computing a measure of ventilation of the patient during the apnea from the signal representative of respiratory flow rate (Col. 2 line 40 - Col. 3 lines 4, the sensor provides a measure of respiratory flow, and the patient’s flow rate is compared to a computed RMS for the past 5 minutes to determine when an apnea is present as a drop in flow below a proportion of the RMS), and
adjusting, in the controller of the ventilator, a set point for the base pressure of the ventilation therapy in response to the apnea based the measure of ventilation during the apnea (Col. 2 line 58 - Col. 3 line 4, Col. 5 line 55 - Col. 6 line 46; The pressure is incremented from a set base point of 4 cmH2O that is an increasing function of the apnea duration when it increases above 10 seconds, up to a maximum pressure increase of 8 cmH2O per minute of apnea; Thus, the longer the ventilation remains below the 25% RMS threshold during the apnea, the greater the increase of pressure to a set point from the base pressure).
Regarding claim 7, Berthon-Jones discloses the method of claim 6.
Berthon-Jones further discloses wherein the adjusting the set point for the base pressure of the ventilation therapy in response to the apnea comprises: computing an effective duration of the apnea dependent on the measure of ventilation during the apnea (Col. 2 line 58 - Col. 3 line 4, Col. 5 line 55 - Col. 6 line 46; A 2 second RMS airflow during the apnea is compared to a longterm average RMS over the past 5 minutes, and if the 2 second RMS airflow is less than 25% of longterm average RMS, then the apnea duration is increased; The effective duration is based on the average RMS for the past two seconds and thus is not an absolute duration and is instead an effective duration), and adjusting the set point for the base pressure based on the effective duration of the apnea (Col. 2 line 58 - Col. 3 line 4, Col. 5 line 55 - Col. 6 line 46, the pressure is incremented the longer the apnea lasts above 10 seconds).
Regarding claim 11, Berthon-Jones discloses a processor-readable medium, having stored thereon processor-executable instructions which, when executed by one or more processors, cause respiratory apparatus to treat a respiratory disorder of a patient (Abstract; also see Col. 5 lines 2-12, the controller includes instructions in memory to perform its programmed functions), the processor-executable instructions comprising:
instructions to control, with a ventilator, a ventilation therapy to the patient through a patient interface, the ventilation therapy having a base pressure (see Fig. 1 and Col. 4 lines 19-31, a blower 34 pressurizes and delivers air as CPAP treatment to the patient through a mask 30; see Col. 2 lines 48 - Col. 3 line 4; The pressure generator is controlled by a controller to provide a first initial treatment pressure of 4 cmH2O),
instructions to detect, in a controller of the ventilator, an apnea from a sensor signal representative of respiratory flow rate of the patient (Col. 2 lines 43-57, a flow sensor can provide a signal to a controller to determine patient respiratory airflow; Col. 2 lines 48-61, an apnea is detected based on the airflow signal being a reduction to below a threshold value, such as 25% of the RMS airflow over the past 5 minutes of normal breathing),
instructions to compute a measure of ventilation of the patient during the apnea from the signal representative of respiratory flow rate (Col. 2 line 40 - Col. 3 lines 4, the sensor provides a measure of respiratory flow, and the patient’s flow rate is compared to a computed RMS for the past 5 minutes to determine when an apnea is present as a drop in flow below a proportion of the RMS), and
instructions to adjust, in the controller of the ventilator, a set point for the base pressure of the ventilation therapy in response to the apnea based the measure of ventilation during the apnea (Col. 2 line 58 - Col. 3 line 4, Col. 5 line 55 - Col. 6 line 46; The pressure is incremented from a set base point of 4 cmH2O that is an increasing function of the apnea duration when it increases above 10 seconds, up to a maximum pressure increase of 8 cmH2O per minute of apnea; Thus, the longer the ventilation remains below the 25% RMS threshold during the apnea, the greater the increase of pressure to a set point from the base pressure).
Regarding claim 12, Berthon-Jones discloses the device of claim 11.
Berthon-Jones further discloses wherein the instructions to adjust the set point for the base pressure of the ventilation therapy in response to the apnea comprise: instructions to compute an effective duration of the apnea dependent on the measure of ventilation during the apnea (Col. 2 line 58 - Col. 3 line 4, Col. 5 line 55 - Col. 6 line 46; A 2 second RMS airflow during the apnea is compared to a longterm average RMS over the past 5 minutes, and if the 2 second RMS airflow is less than 25% of longterm average RMS, then the apnea duration is increased; The effective duration is based on the average RMS for the past two seconds and thus is not an absolute duration and is instead an effective duration), and instructions to adjust the set point for the base pressure based on the effective duration of the apnea (Col. 2 line 58 - Col. 3 line 4, Col. 5 line 55 - Col. 6 line 46, the pressure is incremented the longer the apnea lasts above 10 seconds).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 3-5, 8-10 and 13-15 are rejected under 35 U.S.C. 103 as being unpatentable over Berthon-Jones (U.S 6,367,474 B1), in view of Bassin (WO 2013152403 A1).
Regarding claim 3, Berthon-Jones discloses the device of claim 2.
Berthon-Jones is silent regarding wherein the computing an effective duration comprises, for each apnea detection interval, computing a deweighting factor based on the measure of ventilation during the apnea detection interval, and incrementing a current effective duration of the apnea using the deweighting factor.
However, Bassin teaches computing a weighting scaling factor based on the measure of ventilation during an apnea detection interval, and incrementing the current effective duration of the apnea using the scaling factor (see Paragraphs 251-253, an effective duration of an apnea event over an apnea detection interval can be calculated by first calculating a weight function for each time, with weighting being 1 when an apnea is true, and being multiplied by a scaling factor between 0 and 1 for when apnea is not positively detected but ventilation impedance is high, and thus might be a less severe hypopnea which requires less pressure therapy; Thus, when apnea is positively indicated, weight is 1 for that time period, and when apnea is not positively indicated but patient flow is still obstructed or reduced, then weight is set between 0 and 1 to attribute less duration and according pressure therapy for a less serious obstruction).
Thus, it would have been obvious to one having ordinary skill in the prior art before the effective filing date of the claimed invention to have modified the device of Berthon-Jones to have included computing a weighting scaling factor based on the measure of ventilation during an apnea detection interval, and to adjust/increment the effective duration of the apnea using the scaling factor, such as that taught by Bassin, in order to account for both periods of definite apnea and also high ventilation impedance periods during obstructed breathing (Paragraph 0251) and to apply appropriate levels of pressure therapy according to the severity of obstructions that occur across an apnea detection interval (Paragraph 0253, where full apnea contributes more heavily to the effective duration, and therefore the therapeutic pressure to be applied, than a lesser hypopnea phase).
Regarding claim 4, the modified device of Berthon-Jones discloses the device of claim 3.
Bassin further teaches wherein the deweighting factor decreases from 1 to 0 as the measure of ventilation increases above a threshold (see Paragraph 0251-0253; The weighting is 1 for a full apnea, but is multiplied by the scaling factor between 0 and 1 when apnea is not positively detected but high ventilation impedance is occurring; Berthon-Jones also teaches the threshold for apnea being 25% of the RMS average flow, and thus Bassin teaches weighting of 1 below this apnea threshold, and scaling between 1 to 0 as the flow becomes less obstructed and approaches normal flow).
Regarding claim 5, the modified device of Berthon-Jones discloses the device of claim 4.
Berthon-Jones further discloses wherein the threshold is a small fraction of an expected normal ventilation (Col. 2 lines 48-61, the apnea threshold is a small fraction, i.e. 1/4th of the normal ventilation RMS average).
Regarding claim 8, Berthon-Jones discloses the method of claim 7.
Berthon-Jones is silent regarding wherein the computing an effective duration comprises, for each apnea detection interval, computing a deweighting factor based on the measure of ventilation during the apnea detection interval, and incrementing a current effective duration of the apnea using the deweighting factor.
However, Bassin teaches computing a weighting scaling factor based on the measure of ventilation during an apnea detection interval, and incrementing the current effective duration of the apnea using the scaling factor (see Paragraphs 251-253, an effective duration of an apnea event over an apnea detection interval can be calculated by first calculating a weight function for each time, with weighting being 1 when an apnea is true, and being multiplied by a scaling factor between 0 and 1 for when apnea is not positively detected but ventilation impedance is high, and thus might be a less severe hypopnea which requires less pressure therapy; Thus, when apnea is positively indicated, weight is 1 for that time period, and when apnea is not positively indicated but patient flow is still obstructed or reduced, then weight is set between 0 and 1 to attribute less duration and according pressure therapy for a less serious obstruction).
Thus, it would have been obvious to one having ordinary skill in the prior art before the effective filing date of the claimed invention to have modified the method of Berthon-Jones to have included computing a weighting scaling factor based on the measure of ventilation during an apnea detection interval, and to adjust/increment the effective duration of the apnea using the scaling factor, such as that taught by Bassin, in order to account for both periods of definite apnea and also high ventilation impedance periods during obstructed breathing (Paragraph 0251) and to apply appropriate levels of pressure therapy according to the severity of obstructions that occur across an apnea detection interval (Paragraph 0253, where full apnea contributes more heavily to the effective duration, and therefore the therapeutic pressure to be applied, than a lesser hypopnea phase).
Regarding claim 9, the modified method of Berthon-Jones discloses the method of claim 8.
Bassin further teaches wherein the deweighting factor decreases from 1 to 0 as the measure of ventilation increases above a threshold (see Paragraph 0251-0253; The weighting is 1 for a full apnea, but is multiplied by the scaling factor between 0 and 1 when apnea is not positively detected but high ventilation impedance is occurring; Berthon-Jones also teaches the threshold for apnea being 25% of the RMS average flow, and thus Bassin teaches weighting of 1 below this apnea threshold, and scaling between 1 to 0 as the flow becomes less obstructed and approaches normal flow).
Regarding claim 10, the modified method of Berthon-Jones discloses the method of claim 9.
Berthon-Jones further discloses wherein the threshold is a small fraction of an expected normal ventilation (Col. 2 lines 48-61, the apnea threshold is a small fraction, i.e. 1/4th of the normal ventilation RMS average).
Regarding claim 13, Berthon-Jones discloses the device of claim 12.
Berthon-Jones is silent regarding wherein the instructions to compute an effective duration comprises, instructions to compute, for each apnea detection interval, a deweighting factor based on the measure of ventilation during the apnea detection interval, and instructions to increment, for each apnea detection interval, a current effective duration of the apnea using the deweighting factor.
However, Bassin teaches computing a weighting scaling factor based on the measure of ventilation during an apnea detection interval, and incrementing the current effective duration of the apnea using the scaling factor (see Paragraphs 251-253, an effective duration of an apnea event over an apnea detection interval can be calculated by first calculating a weight function for each time, with weighting being 1 when an apnea is true, and being multiplied by a scaling factor between 0 and 1 for when apnea is not positively detected but ventilation impedance is high, and thus might be a less severe hypopnea which requires less pressure therapy; Thus, when apnea is positively indicated, weight is 1 for that time period, and when apnea is not positively indicated but patient flow is still obstructed or reduced, then weight is set between 0 and 1 to attribute less duration and according pressure therapy for a less serious obstruction).
Thus, it would have been obvious to one having ordinary skill in the prior art before the effective filing date of the claimed invention to have modified the device of Berthon-Jones to have included instructions for computing a weighting scaling factor based on the measure of ventilation during an apnea detection interval, and to adjust/increment the effective duration of the apnea using the scaling factor, such as that taught by Bassin, in order to account for both periods of definite apnea and also high ventilation impedance periods during obstructed breathing (Paragraph 0251) and to apply appropriate levels of pressure therapy according to the severity of obstructions that occur across an apnea detection interval (Paragraph 0253, where full apnea contributes more heavily to the effective duration, and therefore the therapeutic pressure to be applied, than a lesser hypopnea phase).
Regarding claim 14, the modified device of Berthon-Jones discloses the device of claim 13.
Bassin further teaches wherein the deweighting factor decreases from 1 to 0 as the measure of ventilation increases above a threshold (see Paragraph 0251-0253; The weighting is 1 for a full apnea, but is multiplied by the scaling factor between 0 and 1 when apnea is not positively detected but high ventilation impedance is occurring; Berthon-Jones also teaches the threshold for apnea being 25% of the RMS average flow, and thus Bassin teaches weighting of 1 below this apnea threshold, and scaling between 1 to 0 as the flow becomes less obstructed and approaches normal flow).
Regarding claim 15, the modified device of Berthon-Jones discloses the device of claim 14.
Berthon-Jones further discloses wherein the threshold is a small fraction of an expected normal ventilation (Col. 2 lines 48-61, the apnea threshold is a small fraction, i.e. 1/4th of the normal ventilation RMS average).
Conclusion
THIS ACTION IS MADE FINAL. 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 THOMAS WILLIAM GREIG whose telephone number is (571)272-5378. The examiner can normally be reached Monday - Thursday: 7:30AM - 5:00PM.
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/THOMAS W GREIG/Examiner, Art Unit 3785
/JOSEPH D. BOECKER/Primary Examiner, Art Unit 3785