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 .
Status of Claims
The present Office action is responsive to the application as filed on 12-12-2023. As directed, claims 1-51 are currently pending examination.
Claim Objections
Claims 1, 6-7, 9, 14-15, 18-21, 25, 27, 43-47, and 49-51 objected to because of the following informalities:
At claim 1, lines 4-5, it is suggested that “a portion of the inhalation periods including an end of the inhalation period” be replaced with “a portion of each of the plurality of inhalation periods including an end of each inhalation period” for consistency and clarity in the claim.
At claim 1, lines 6-7, it is suggested that “a portion of the exhalation periods including an end of the exhalation period” be replaced with “a portion of each of the plurality of exhalation periods including an end of each exhalation period” for consistency and clarity in the claim.
At claim 6, line 2, it is suggested that “the beginning” be replaced with “a beginning” as the claim term has not yet been introduced.
At claim 6, line 2, it is suggested that “the next inhalation period” be replaced with “a next inhalation period” as the claim term has not yet been introduced.
At claim 7, line 1, it is suggested that “the beginning” be replaced with “a beginning” as the claim term has not yet been introduced.
At claim 7, lines 1-2, it is suggested that “the next inhalation period” be replaced with “a next inhalation period” as the claim term has not yet been introduced.
At claim 9, line 1, it is suggested that “the beginning” be replaced with “a beginning” as the claim term has not yet been introduced.
At claim 9, lines 1-2, it is suggested that “the next inhalation period” be replaced with “a next inhalation period” as the claim term has not yet been introduced.
At claim 14, line 4, it is suggested that “the exhalation period” be replaced with “each exhalation period” for consistency in the claims.
At claim 15, line 4, it is suggested that “the exhalation period” be replaced with “each exhalation period” for consistency in the claims.
At claim 18, lines 1-2, it is suggested that “the inhalation period” be replaced with “each inhalation period” for consistency in the claims.
At claim 19, line 1, it is suggested that “the beginning” be replaced with “a beginning” as the claim term has not yet been introduced.
At claim 19, lines 1-2, it is suggested that “the next exhalation period” be replaced with “a next exhalation period” as the claim term has not yet been introduced.
At claim 20, line 1, it is suggested that “the beginning” be replaced with “a beginning” as the claim term has not yet been introduced.
At claim 20, lines 1-2, it is suggested that “the next exhalation period” be replaced with “a next exhalation period” as the claim term has not yet been introduced.
At claim 21, line 1, it is suggested that “the beginning” be replaced with “a beginning” as the claim term has not yet been introduced.
At claim 21, lines 1-2, it is suggested that “the next exhalation period” be replaced with “a next exhalation period” as the claim term has not yet been introduced.
At claim 25, line 4, it is suggested that “the exhalation period” be replaced with “each exhalation period” for consistency in the claims.
At claim 27, line 4, it is suggested that “the exhalation period” be replaced with “each exhalation period” for consistency in the claims.
At claim 43, lines 5-6, it is suggested that “a portion of the inhalation periods including an end of the inhalation period” be replaced with “a portion of each of the plurality of inhalation periods including an end of each inhalation period” for consistency and clarity in the claim.
At claim 43, lines 6-7, it is suggested that “a portion of the exhalation periods including an end of the exhalation period” be replaced with “a portion of each of the plurality of exhalation periods including an end of each exhalation period” for consistency and clarity in the claim.
At claim 44, line 4, it is suggested that “the exhalation period” be replaced with “each exhalation period” for consistency in the claims.
At claim 45, line 3, it is suggested that “the exhalation period” be replaced with “each exhalation period” for consistency in the claims.
At claim 45, line 4, it is suggested that “the exhalation period” be replaced with “each exhalation period” for consistency in the claims.
At claim 46, lines 2-3, it is suggested that “the exhalation period” be replaced with “each exhalation period” for consistency in the claims.
At claim 47, lines 5-6, it is suggested that “a portion of the exhalation periods including an end of the exhalation period” be replaced with “a portion of each of the plurality of exhalation periods including an end of each exhalation period” for consistency and clarity in the claim.
At claim 47, line 7, it is suggested that “a portion of the inhalation periods” be replaced with “a portion of each of the plurality of inhalation periods” for consistency and clarity in the claim.
At claim 49, lines 7-8, it is suggested that “a portion of the inhalation periods including an end of the inhalation period” be replaced with “a portion of each of the plurality of inhalation periods including an end of each inhalation period” for consistency and clarity in the claim.
At claim 49, lines 9-10, it is suggested that “a portion of the exhalation periods including an end of the exhalation period” be replaced with “a portion of each of the plurality of exhalation periods including an end of each exhalation period” for consistency and clarity in the claim.
At claim 49, line 12, it is suggested that “the exhalation period” be replaced with “each exhalation period” for consistency in the claims.
At claim 50, line 5, it is suggested that “the type of patient interface connected to the patient’s respiratory system” be replaced with “a type of patient interface configured to be connected to the patient’s respiratory system” to properly introduce a new claim term and to more explicitly avoid claiming the human organism.
At claim 51, line 3, it is suggested that “the air flow” be replaced with “an air flow” as the term has not yet been introduced.
At claim 51, line 6, it is suggested that “the air flow” be replaced with “an air flow” as the term has not yet been introduced.
Appropriate correction is required.
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.
Claims 1, 5-8, 17-20, 27, 33, 43, 49, and 51 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Colbaugh (US 2014/0109910).
Regarding claim 1, Colbaugh discloses a method for treating sleep disordered breathing (abstract, lines 1-5; paragraph 39, lines 1-13; paragraph 40, lines 8-11; paragraph 41, lines 15-17; paragraph 42, lines 1-5; Figs. 4-7), the method comprising:
providing pressure into a patient's airway over a period of time that includes a plurality of inhalation periods (2) and a plurality of exhalation periods (3) (paragraph 39, lines 1-13 and Fig. 4; or paragraph 40, lines 8-11 and Fig. 5; or paragraph 41, lines 15-17 and Fig. 6; or paragraph 42, lines 1-5 and Fig. 7);
wherein the pressure is at a relief positive airway pressure during a portion of the inhalation periods (2) including an end of the inhalation period (see Fig. 4, where the pressure during inhalation periods 2 ranges from a relief positive airway pressure of 0-12 cm H2O; see Figs. 5-7, where the pressure during inhalation periods 2 ranges from a relief positive airway pressure of 4-12 cm H2O);
wherein the pressure is at a therapy positive airway pressure during a portion of the exhalation periods (3) including an end of the exhalation period, the therapy positive airway pressure greater than the relief positive airway pressure (see Fig. 4, where the pressure during exhalation periods 3 ranges from a therapy positive airway pressure of 12-16 cm H2O; see Figs. 5-6, where the pressure during exhalation periods 3 is a therapy positive airway pressure of 12 cm H2O; see Fig. 7, where the pressure during exhalation periods 3 ramps up from 4 cm H2O to about 12 cm H2O; note that in each waveform, at least a portion of the exhalation period therapy positive pressure is greater than at least a portion of the inhalation period relief positive pressure, e.g. the peak pressure during exhalation in each waveform is greater than the lowest pressure during inhalation); and
wherein the pressure decreases from the therapy positive airway pressure to the relief positive airway pressure after the end of the exhalation period (see Figs. 4-7, where the pressure at the end of each exhalation period 3 experiences a decrease when the period switches from exhalation 3 to inhalation 2).
Regarding claim 5, Colbaugh discloses the method of claim 1, as discussed above.
Colbaugh further discloses wherein the therapy positive airway pressure is maintained for a period of time (paragraph 10, lines 1-4; see Figs. 4-7, where the pressure during exhalation periods 3 is maintained throughout each exhalation period; more particularly, the portion of the pressure waveform for each exhalation period 3 that is greater than the lowest inhalation period pressure is maintained for a period of time on each waveform).
Regarding claim 6, Colbaugh discloses the method of claim 5, as discussed above.
Colbaugh further discloses wherein the period of time extends between about 0 seconds and about 2 seconds after the beginning of the next inhalation period (see each of Figs. 4-7, where the pressure during each exhalation period 3 experiences a pressure drop as soon as an inhalation period 2 is entered, thus the exhalation pressure is reasonably maintained until 0 seconds after the beginning of the following inhalation period).
Regarding claim 7, Colbaugh discloses the method of claim 5, as discussed above.
Colbaugh further discloses wherein the period of time extends after the beginning of the next inhalation period between about 0% seconds and about 50% of an expected length of the next inhalation period (see each of Figs. 4-7, where the pressure during each exhalation period 3 experiences a pressure drop as soon as an inhalation period 2 is entered, thus the exhalation pressure is reasonably maintained until 0% of the length of the following inhalation period).
Regarding claim 8, Colbaugh discloses the method of claim 5, as discussed above.
Colbaugh further discloses wherein the period of time extends until a triggering event occurs (see each of Figs. 4-7, where inhalation triggers the pressure drop between each of exhalation periods 3 and inhalation periods 2; paragraph 38, lines 1-8).
Regarding claim 17, Colbaugh discloses the method of claim 1, as discussed above.
Colbaugh further discloses wherein the relief positive airway pressure is maintained for a period of time (paragraph 10, lines 1-4; see Figs. 4-7, where the pressure during inhalation periods 2 is maintained throughout each inhalation period; more particularly, the portion of the pressure waveform for each inhalation period 2 that is less than the exhalation period pressure is maintained for a period of time on each waveform).
Regarding claim 18, Colbaugh discloses the method of claim 17, as discussed above.
Colbaugh further discloses wherein the period of time includes substantially all of the inhalation period (see Figs. 4-5, where the portion of the pressure waveform for inhalation periods 2 that is less than the pressure during exhalation periods 3 covers substantially the entire inhalation period with the exception of the very beginning of the inhalation phase and the period of inhalation right before crossing into exhalation; see Figs. 6-7, where the portion of the pressure waveform for inhalation periods 2 that is less than the pressure during exhalation periods 3 covers substantially the entire inhalation period).
Regarding claim 19, Colbaugh discloses the method of claim 17, as discussed above.
Colbaugh further discloses wherein the period of time extends after the beginning of the next exhalation period between about 0 seconds and about 5 seconds (see each of Figs. 4-7, where the pressure during each exhalation period 3 experiences a pressure increase as soon as an inhalation period 2 is ended, thus the inhalation pressure is reasonably maintained until 0 seconds after the beginning of the following exhalation period).
Regarding claim 20, Colbaugh discloses the method of claim 17, as discussed above.
Colbaugh further discloses wherein the period of time extends after the beginning of the next exhalation period between about 0% and about 80% of an expected length of the next exhalation period (see each of Figs. 4-7, where the pressure during each exhalation period 3 experiences a pressure increase as soon as an inhalation period 2 is ended, thus the inhalation pressure is reasonably maintained until 0% of an expected length the following exhalation period).
Regarding claim 27, Colbaugh discloses the method of claim 1, as discussed above.
Colbaugh further discloses wherein, during the exhalation period, the pressure increases from the relief positive airway pressure to the therapy positive airway pressure over a therapy transition period (paragraph 38, lines 1-8; see each of Figs. 4-7, where the pressure increases up to the peak exhalation pressure in time periods 3 from the lowest inhalation period pressure over a ramped time period, this ramped period is the therapy transition period).
Regarding claim 33, Colbaugh discloses the method of claim 1, as discussed above.
Colbaugh further discloses wherein the pressure decreases from the therapy positive airway pressure to the relief positive airway pressure over a relief transition period (paragraph 38, lines 1-8; see each of Figs. 4-7, where the pressure decreases to the lowest inhalation pressure in time periods 2 from the exhalation period pressure over a gradual time period, this gradual time period of decay is the relief transition period).
Regarding claim 43, Colbaugh discloses a method for treating sleep disordered breathing (abstract, lines 1-5; paragraph 39, lines 1-13; paragraph 42, lines 1-5; Fig. 7), the method comprising:
providing pressure into a patient's airway over a period of time that includes a plurality of inhalation periods (2) and a plurality of exhalation periods (3) (paragraph 39, lines 1-13; paragraph 42, lines 1-5 and Fig. 7), the pressure varying between a lower relief positive airway pressure and a higher therapy positive airway pressure (see Fig. 7, where the pressure during inhalation periods 2 and prior to the peak in exhalation period 3 is regarded as the relief positive airway pressure, and the peak of the exhalation period 3 is regarded as the therapy positive airway pressure, where the peak of the pressure is higher than the remaining portions of the waveform);
wherein the pressure is at a relief positive airway pressure during a portion of the inhalation periods (2) including an end of the inhalation period and a portion of the exhalation periods (3) including the end of the exhalation period (3) (see Fig. 7, where the identified relief positive airway pressure extends from the beginning of inhalation until the end of exhalation right before the peak pressure during exhalation located towards the end of the exhalation cycle; note also paragraph 42, lines 1-12 and paragraph 38, lines 8-11).
Regarding claim 49, Colbaugh discloses a system (100) for treating sleep disordered breathing (abstract, lines 1-5; paragraph 15, lines 1-7; Fig. 1), the system (100) comprising:
a flow generator (140) (paragraph 16, lines 1-7); and
a conduit (182) operably connected to the flow generator (140), the conduit (182) having an outlet (end of conduit 182 near interface 184) configured to connect to a patient's respiratory system via a patient interface (184) to provide pressure into a patient's airway over a period of time that includes a plurality of inhalation periods and a plurality of exhalation periods (paragraph 16, lines 1-7; paragraph 19, lines 1-13; Fig. 1);
wherein the flow generator (140) provides a relief positive airway pressure during a portion of the inhalation periods (2) including an end of the inhalation period (paragraph 39, lines 1-13 and Fig. 4; or paragraph 40, lines 8-11 and Fig. 5; or paragraph 41, lines 15-17 and Fig. 6; or paragraph 42, lines 1-5 and Fig. 7; see Fig. 4, where the pressure during inhalation periods 2 ranges from a relief positive airway pressure of 0-12 cm H2O; see Figs. 5-7, where the pressure during inhalation periods 2 ranges from a relief positive airway pressure of 4-12 cm H2O);
wherein the flow generator (140) provides a therapy positive airway pressure during a portion of the exhalation periods (3) including an end of the exhalation period, the therapy positive airway pressure greater than the relief positive airway pressure (see Fig. 4, where the pressure during exhalation periods 3 ranges from a therapy positive airway pressure of 12-16 cm H2O; see Figs. 5-6, where the pressure during exhalation periods 3 is a therapy positive airway pressure of 12 cm H2O; see Fig. 7, where the pressure during exhalation periods 3 ramps up from 4 cm H2O to about 12 cm H2O; note that in each waveform, at least a portion of the exhalation period therapy positive pressure is greater than at least a portion of the inhalation period relief positive pressure, e.g. the peak pressure during exhalation in each waveform is greater than the lowest pressure during inhalation); and
wherein the pressure decreases from the therapy positive airway pressure to the relief positive airway pressure after the end of the exhalation period (see each of Figs. 4-7, where the pressure decreases from the peak exhalation pressure in period 3 to the lowest inhalation pressure in period 2 following an exhalation period 3).
Regarding claim 51, Colbaugh discloses a computer with a processor (110) (paragraph 33, lines 1-10; Fig. 1), the processor (110) configured to control the flow generator (140) based on feedback provided from at least one of:
a flow meter (142) configured to measure the air flow provided by the flow generator (paragraph 30, lines 1-7, see “flow”; paragraph 31, lines 1-7 and 13-17; paragraph 33, lines 1-10; paragraph 35, lines 1-8; paragraph 36, lines 1-4; paragraph 37, lines 1-2 and 26-29);
a pressure sensor configured to measure the pressure provided into the patient's airway (paragraph 30, lines 1-7, see “pressure”; paragraph 31, lines 1-7 and 13-17; paragraph 33, lines 1-10; paragraph 35, lines 1-8; paragraph 36, lines 1-4; paragraph 37, lines 1-2 and 26-29); and
a patient flow sensor configured to monitor the air flow produced by the patient's lungs (paragraph 30, lines 1-7; paragraph 31, lines 1-7 and 13-17; paragraph 33, lines 1-10; paragraph 35, lines 1-8, note “flow of breathable gas in or out of the airway”; paragraph 36, lines 1-4; paragraph 37, lines 1-2 and 26-29).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or non-obviousness.
Claims 2-3 are rejected under 35 U.S.C. 103 as being unpatentable over Colbaugh (US 2014/0109910), as applied to claim 1 above, in view of McLaren (US 2020/0129720).
Regarding claim 2, Colbaugh discloses the method of claim 1, as discussed above.
Colbaugh fails to explicitly disclose wherein a difference between the relief positive airway pressure and the therapy positive airway pressure is about 3 cm H2O to about 4 cm H2O.
However, when describing bi-level PAP ventilation, McLaren teaches that it is known to vary an inspiratory positive airway pressure (IPAP) relative to an expiratory positive airway pressure (EPAP) by an amount between 1 and 10 cm H2O (paragraph 8, lines 8-13).
In the case where the range taught by the claimed ranges lie inside those disclosed/taught by the prior art, a prima facie case of obviousness exists (see MPEP 2144.05 I). In the instant case, the range of 3-4 cm H2O lies within the range of 1-10 cm H2O taught by McLaren, thereby rendering the claimed range obvious.
Given that Colbaugh discloses a type of bi-level PAP and that the claimed range lies within the range taught by McLaren, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have selected a difference in pressure between the relief positive airway pressure and the therapy positive airway pressure to be about 3 cm H2O to about 4 cm H2O, as a known range of values for varying inspiratory pressure levels relative to expiratory pressure levels in a bi-level PAP system and method.
Regarding claim 3, Colbaugh discloses the method of claim 1, as discussed above.
Colbaugh fails to explicitly disclose wherein a difference between the relief positive airway pressure and the therapy positive airway pressure is less than about 40% of the therapy positive airway pressure.
However, when describing bi-level PAP ventilation, McLaren teaches that it is known to vary an inspiratory positive airway pressure (IPAP) relative to an expiratory positive airway pressure (EPAP) by an amount between 1 and 10 cm H2O (paragraph 8, lines 8-13).
In the case where the range taught by the claimed ranges lie inside those disclosed/taught by the prior art, a prima facie case of obviousness exists (see MPEP 2144.05 I).
Given that Colbaugh discloses a type of bi-level PAP, and further discloses a therapy positive pressure value of about 12 cm H2O (see Figs. 6-7 in periods 3), it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have selected a difference in pressure between the relief positive airway pressure and the therapy positive airway pressure to be in the range of about 4.8 cm H2O or less, which coincides with 40% or less of the value of 12 cm H2O, and is contained within McLaren’s taught range, as a known range of values for varying inspiratory pressure levels relative to expiratory pressure levels in a bi-level PAP system and method.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Colbaugh (US 2014/0109910), as applied to claim 1 above, in view of Ross Jr. (US 2013/0239961).
Regarding claim 4, Colbaugh discloses the method of claim 1, as discussed above.
Colbaugh further discloses wherein a user interface (120) is provided in order for the patient to provide feedback to the system (100) (paragraph 27, lines 1-8).
However, Colbaugh fails to explicitly disclose a step of the patient choosing the relief positive airway pressure that is equal to or above a predetermined minimum pressure level.
Ross Jr. teaches a portable breathing assistance device capable of delivering bi-PAP ventilation (paragraph 48, lines 1-9), and including the step of a caregiver choosing the relief positive airway pressure that is equal to or above a predetermined minimum pressure level (paragraph 48, lines 9-18, see “vary the IPAP and/or EPAP levels”, and note that the lowest setting allowed by the machine is considered the predetermined minimum pressure for the IPAP/EPAP levels).
Given that Colbaugh discloses and describes similar control functionalities as those taught by Ross Jr., and also discloses that either a patient or caregiver can manipulate those controls (see paragraph 27 of Colbaugh), it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Colbaugh to include the step of the patient choosing the relief positive airway pressure that is equal to or above a predetermined minimum pressure level, such that the patient were able to select a pressure level that best corresponds to their comfort.
Claims 9, 11, 13, 21, and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Colbaugh (US 2014/0109910), as applied to claims 8 and 17 above, in view of Farrugia (US 2015/0047639).
Regarding claim 9, Colbaugh discloses the method of claim 8, as discussed above.
While Colbaugh indicates that the triggering event is an inhalation (see each of Figs. 4-7, where inhalation triggers the pressure drop between each of exhalation periods 3 and inhalation periods 2; paragraph 38, lines 1-8), Colbaugh fails to disclose wherein the triggering event is an inhalation volume after the beginning of the next inhalation period reaching an inhalation volume threshold.
However, Farrugia teaches a method of integrating flow in a CPAP system wherein integration of the flow results in calculation of a volume, and exhalation is taken to occur when the calculated volume is negative, and inhalation is taken to occur when the calculated volume is positive (paragraph 70, lines 1-4; see also paragraphs 79-80 where the crossing of the values from negative to positive is used to set a new targeted pressure).
Given that Colbaugh contemplates the triggering event to coincide with a transition between exhalation and inhalation (paragraph 35, lines 1-10 and paragraph 38, lines 1-8), it would have been obvious to one of ordinary skill in the art to modify the method of Colbaugh by determining the integral of a flow in order to determine a calculated volume and assign negative volumes to exhalation and positive volumes to inhalation, as taught by Farrugia, and thus assign an inhalation volume threshold value as a positive flow value for the triggering event in the beginning of a next inhalation period, as a manner of using flow data from the patient to determine how to transition control of the pressure/flow profile of the system to align with a patient’s inhalation as desired.
Regarding claim 11, Colbaugh discloses the method of claim 8, as discussed above.
While Colbaugh indicates that the triggering event is an inhalation (see each of Figs. 4-7, where inhalation triggers the pressure drop between each of exhalation periods 3 and inhalation periods 2; paragraph 38, lines 1-8), Colbaugh fails to disclose wherein the triggering event is an airflow after the beginning of the next inhalation period reaching an airflow threshold value.
However, Farrugia teaches a method of determining a zero crossing in a CPAP system in order to determine transitions between inhalation and exhalation, wherein exhalation is taken to occur when the value is negative, and inhalation is taken to occur when the value is positive (paragraph 68, lines 6-13; see also paragraphs 79-80 where the crossing of the values from negative to positive is used to set a new targeted pressure).
Given that Colbaugh contemplates the triggering event to coincide with a transition between exhalation and inhalation (paragraph 35, lines 1-10 and paragraph 38, lines 1-8), it would have been obvious to one of ordinary skill in the art to modify the method of Colbaugh by determining a crossing of an air flow threshold value into the positive domain as a transition to inhalation, as taught by Farrugia, and thus assign an air flow threshold value as a positive flow value for the triggering event in the beginning of a next inhalation period, as a manner of using flow data from the patient to determine transitional control of the pressure/flow profile of the system to align with a patient’s inhalation as desired.
Regarding claim 13, Colbaugh discloses the method of claim 8, as discussed above.
While Colbaugh indicates that the triggering event is an inhalation (see each of Figs. 4-7, where inhalation triggers the pressure drop between each of exhalation periods 3 and inhalation periods 2; paragraph 38, lines 1-8), Colbaugh fails to disclose wherein the triggering event is zero patient flow.
However, Farrugia teaches a method of determining a zero flow crossing in a CPAP system in order to determine transitions between inhalation and exhalation, wherein exhalation is taken to occur when the value is negative, and inhalation is taken to occur when the value is positive, and the transition between the two triggers a change in supplied pressure (paragraph 68, lines 6-13; see also paragraphs 79-80 where the crossing of the values from negative to positive is used to set a new targeted pressure).
Given that Colbaugh contemplates the triggering event to coincide with a transition between exhalation and inhalation (paragraph 35, lines 1-10 and paragraph 38, lines 1-8), it would have been obvious to one of ordinary skill in the art to modify the method of Colbaugh by determining a zero crossing of patient air flow, as taught by Farrugia, and thus control the supplied pressure/flow to a new desired level based on the zero crossing, as a manner of using flow data from the patient to determine transitional control of the pressure/flow profile of the system to align with a patient’s inhalation as desired.
Regarding claim 21, Colbaugh discloses the method of claim 17, as discussed above.
While Colbaugh indicates that the triggering event is an exhalation (see each of Figs. 4 and 6-7, where exhalation triggers the pressure increase up to a peak exhalation pressure following each of inhalation periods 2; paragraph 38, lines 1-8), Colbaugh fails to disclose wherein the triggering event is an airflow after the beginning of the next exhalation period reaching an airflow threshold value.
However, Farrugia teaches a method of determining a zero crossing in a CPAP system in order to determine transitions between inhalation and exhalation, wherein exhalation is taken to occur when the value is negative, and inhalation is taken to occur when the value is positive (paragraph 68, lines 6-13; see also paragraphs 79-80 where the crossing of the values from negative to positive is used to set a new targeted pressure).
Given that Colbaugh contemplates the triggering event to coincide with a transition between inhalation and exhalation (paragraph 35, lines 1-10 and paragraph 38, lines 1-8), it would have been obvious to one of ordinary skill in the art to modify the method of Colbaugh by determining a crossing of an air flow threshold value into the negative domain as a transition to exhalation, as taught by Farrugia, and thus assign an air flow threshold value as a negative flow value for the triggering event in the beginning of a next exhalation period, as a manner of using flow data from the patient to determine transitional control of the pressure/flow profile of the system to align with a patient’s exhalation as desired.
Regarding claim 24, Colbaugh discloses the method of claim 17, as discussed above.
While Colbaugh indicates that the triggering event is an inhalation (see each of Figs. 4 and 6-7, where exhalation triggers the pressure increase up to a peak exhalation pressure following each of inhalation periods 2; paragraph 38, lines 1-8), Colbaugh fails to disclose wherein the triggering event is zero patient flow.
However, Farrugia teaches a method of determining a zero flow crossing in a CPAP system in order to determine transitions between inhalation and exhalation, wherein exhalation is taken to occur when the value is negative, and inhalation is taken to occur when the value is positive, and the transition between the two triggers a change in supplied pressure (paragraph 68, lines 6-13; see also paragraphs 79-80 where the crossing of the values from negative to positive is used to set a new targeted pressure).
Given that Colbaugh contemplates the triggering event to coincide with a transition between exhalation and inhalation (paragraph 35, lines 1-10 and paragraph 38, lines 1-8), it would have been obvious to one of ordinary skill in the art to modify the method of Colbaugh by determining a zero crossing of patient air flow, as taught by Farrugia, and thus control the supplied pressure/flow to a new desired level based on the zero crossing, as a manner of using flow data from the patient to determine transitional control of the pressure/flow profile of the system to align with a patient’s exhalation as desired.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Colbaugh (US 2014/0109910), as applied to claim 8 above, in view of Adametz (US 2022/0160990).
Regarding claim 9, Colbaugh discloses the method of claim 8, as discussed above.
While Colbaugh indicates that the triggering event is an inhalation (see each of Figs. 4-7, where inhalation triggers the pressure drop between each of exhalation periods 3 and inhalation periods 2; paragraph 38, lines 1-8), Colbaugh fails to disclose wherein the triggering event is an inhalation volume after the beginning of the next inhalation period reaching an inhalation volume threshold.
However, Adametz further teaches wherein a triggering event for transition in therapeutic pressure level is an inhalation volume after the beginning of the next inhalation period reaching an inhalation volume threshold, based on tidal volume measured, in order to drive the inhalation pressure value to an appropriate level (see paragraphs 90-95).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Colbaugh to provide the triggering event responsive to determination that an inhalation volume after the beginning of the next inhalation period reaches an inhalation volume threshold that is based on tidal volume, as taught by Adametz, in order to appropriately drive the inhalation pressure value to the desired support level based on detection of inhalation at a particular threshold value.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Colbaugh (US 2014/0109910) in view of in view of Adametz (US 2022/0160990), as applied to claim 9 above, in further view of Laura Lapoint (US 2015/0306325).
Regarding claim 10, Colbaugh in view of Adametz disclose the method of claim 9, as discussed above.
Modified Colbaugh further discloses wherein the inhalation volume threshold value is determined based on a tidal volume measured (paragraphs 90-95 of Adametz, note comparison between a first set volume and a current tidal volume).
Presently modified Colbaugh fails to disclose wherein the tidal volume threshold is based on a tidal volume measured during one or more previous inhalation periods.
However, Laura Lapoint teaches configuring various breath parameter thresholds in a CPAP system based on previous breathing cycles of the user (paragraph 33, lines 6-10).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of modified Colbaugh to configure the threshold for the tidal volume-based triggering event to be based on measurements of tidal volume for previous inhalation periods of the patient, as taught by Laura Lapoint, in order to individualize the control parameters to the patient.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Colbaugh (US 2014/0109910), as applied to claim 8 above, in view of Bassin (US 2021/0008311).
Regarding claim 11, Colbaugh discloses the method of claim 8, as discussed above.
While Colbaugh indicates that the triggering event is an inhalation (see each of Figs. 4-7, where inhalation triggers the pressure drop between each of exhalation periods 3 and inhalation periods 2; paragraph 38, lines 1-8), Colbaugh fails to disclose wherein the triggering event is an airflow after the beginning of the next inhalation period reaching an airflow threshold value.
However, Bassin teaches that a triggering event for switching between an IPAP and an EPAP value can be an airflow after the beginning of the next inhalation period reaching an airflow threshold value (paragraph 5, lines 1-9, note that when the value is above the threshold, IPAP is delivered, and upon air flow falling below the threshold, EPAP is delivered).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Colbaugh such that the triggering event is an airflow after the beginning of the next inhalation period reaching an airflow threshold value, as taught by Bassin, as a manner of controlling a pressure output in a respiratory system in order to align inhalation and expiration pressures with desired, different levels.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Colbaugh (US 2014/0109910) in view of in view of Bassin (US 2021/0008311), as applied to claim 11 above, in further view of Laura Lapoint (US 2015/030325).
Regarding claim 12, Colbaugh in view of Bassin disclose the method of claim 11, as discussed above.
Modified Colbaugh further discloses wherein the air flow threshold value is determined based on a peak flow (paragraph 5, lines 1-9 of Bassin, note “percentage of peak”).
Presently modified Colbaugh fails to disclose wherein the air flow threshold is based on a peak onhalation flow measured during one or more previous inhalation periods.
However, Laura Lapoint teaches configuring various breath parameter thresholds in a CPAP system based on previous breathing cycles of the user (paragraph 33, lines 6-10).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of modified Colbaugh to configure the threshold for the air flow threshold triggering event to be based on previous peak inhalation values for one or more previous inhalation periods inhalation of the patient, as taught by Laura Lapoint, in order to individualize the control parameters to the patient.
Claims 14, 25, 30-31, 36-37, and 44-46 are rejected under 35 U.S.C. 103 as being unpatentable over Colbaugh (US 2014/0109910), as applied to claims 5, 17, 27, 33, and 43 above, in view of Mechlenberg (US 2011/0240025).
Regarding claim 14, Colbaugh discloses the method of claim 5, as discussed above.
Colbaugh fails to disclose wherein the period of time the therapy positive airway pressure is maintained is proportional to a difference between the relief positive airway pressure and the therapy positive airway pressure, such that, when the difference is greater, the therapy positive airway pressure is maintained for more time before the end of the exhalation period.
However, Mechlenberg teaches a method of providing bi-level positive pressure support therapy (paragraph 42, lines 1-4; Fig. 4), wherein the period of time the higher positive airway pressure is maintained is proportional to a difference between the lower positive airway pressure and the higher positive airway pressure, such that, when the difference is greater, the higher positive airway pressure is maintained for more time in order to gradually increase the pressure values between their peaks and valleys which helps to improve patient comfort (paragraph 22, lines 16-25, note use of the term “gradual” and “straight lines (fixed rates”, indicating that a constant slope for the transitions is contemplated; Figs. 4 and 6-7, note that when the peak of the graph is higher, the time period that the higher pressure is maintained is longer than scenarios where the higher pressure is lower, and thus, the hold time of the higher therapy pressure increases as the higher therapy pressure level increases).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Colbaugh to have the period of time the therapy positive airway pressure is maintained be proportional to a difference between the relief positive airway pressure and the therapy positive airway pressure, such that, when the difference is greater, the therapy positive airway pressure is maintained for more time before the end of the exhalation period, as taught by Mechlenberg, in order to gradually increase the pressure values between their peaks and valleys which helps to improve patient comfort.
Regarding claim 25, Colbaugh discloses the method of claim 17, as discussed above.
Colbaugh fails to disclose wherein the period of time the relief positive airway pressure is maintained is proportional to a difference between the relief positive airway pressure and the therapy positive airway pressure, such that, when the difference is greater, the relief positive airway pressure is maintained for less time before the end of the exhalation period.
However, Mechlenberg teaches a method of providing bi-level positive pressure support therapy (paragraph 42, lines 1-4; Fig. 4), wherein the period of time the lower positive airway pressure is maintained is proportional to a difference between the lower positive airway pressure and the higher positive airway pressure, such that, when the difference is greater, the lower positive airway pressure is maintained for less time in order to facilitate gradual increase and decrease of the pressure values between their peaks and valleys which helps to improve patient comfort (paragraph 22, lines 16-25, note use of the term “gradual” and “straight lines (fixed rates”, indicating that a constant slope for the transitions is contemplated; Figs. 4 and 6-7, note that when the peak of the graph is higher, the time period that the higher pressure is maintained is longer than scenarios where the higher pressure is lower, and thus, the hold time of the lower positive pressure decreases relative to its percent of the entire respiratory cycle as the higher therapy pressure level increases and the difference is greater).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Colbaugh to have the period of time the relief positive airway pressure is maintained be proportional to a difference between the relief positive airway pressure and the therapy positive airway pressure, such that, when the difference is greater, the relief positive airway pressure is maintained for less time before the end of the exhalation period, as taught by Mechlenberg, in order to gradually increase and decrease the pressure values between their peaks and valleys which helps to improve patient comfort.
Regarding claim 30, Colbaugh discloses the method of claim 27, as discussed above.
Colbaugh fails to discloses wherein the pressure increases proportionally to the therapy positive airway pressure.
However, Mechlenberg teaches a method of providing bi-level positive pressure support therapy (paragraph 42, lines 1-4; Fig. 4), wherein the pressure increases proportionally to the higher positive airway pressure in order to facilitate gradual increase and decrease of the pressure values between their peaks and valleys which helps to improve patient comfort (paragraph 22, lines 16-25, note use of the term “gradual” and “straight lines (fixed rates”, indicating that a constant slope for the transitions is contemplated, and being that slope is equal to rise over run, the slope is proportional to the rise in pressure between the peak and valley; Figs. 4 and 6-7, note that when the peak of the graph is higher, the time period that the higher pressure is maintained is longer than scenarios where the higher pressure is lower, and thus, the hold time of the lower positive pressure decreases relative to its percent of the entire respiratory cycle as the higher therapy pressure level increases and the difference is greater).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Colbaugh such that the pressure increases proportionally to the therapy positive airway pressure, as taught by Mechlenberg, in order to gradually increase the pressure values between their peaks and valleys which helps to improve patient comfort.
Regarding claim 31, Colbaugh discloses the method of claim 27, as discussed above.
Colbaugh fails to discloses wherein the pressure increases proportionally to a difference between the relief positive airway pressure and the therapy positive airway pressure.
However, Mechlenberg teaches a method of providing bi-level positive pressure support therapy (paragraph 42, lines 1-4; Fig. 4), wherein the pressure increases proportionally to a difference between the lower positive airway pressure and the higher positive airway pressure in order to facilitate gradual increase of the pressure values between their peaks and valleys which helps to improve patient comfort (paragraph 22, lines 16-25, note use of the term “gradual” and “straight lines (fixed rates”, indicating that a constant slope for the transitions is contemplated, and being that slope is equal to rise over run, the slope is proportional to the rise in pressure between the peak and valley, which is equivalent to the difference in each pressure level; Figs. 4 and 6-7, note that when the peak of the graph is higher, the time period that the higher pressure is maintained is longer than scenarios where the higher pressure is lower, and thus, the hold time of the lower positive pressure decreases relative to its percent of the entire respiratory cycle as the higher therapy pressure level increases and the difference is greater).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Colbaugh such that wherein the pressure increases proportionally to a difference between the relief positive airway pressure and the therapy positive airway pressure, as taught by Mechlenberg, in order to gradually increase the pressure values between their peaks and valleys which helps to improve patient comfort.
Regarding claim 36, Colbaugh discloses the method of claim 33, as discussed above.
Colbaugh fails to discloses wherein the pressure decreases proportionally to the therapy positive airway pressure.
However, Mechlenberg teaches a method of providing bi-level positive pressure support therapy (paragraph 42, lines 1-4; Fig. 4), wherein the pressure decreases proportionally to the higher positive airway pressure in order to facilitate gradual decrease of the pressure values between their peaks and valleys which helps to improve patient comfort (paragraph 22, lines 16-25, note use of the term “gradual” and “straight lines (fixed rates”, indicating that a constant slope for the transitions is contemplated, and being that slope is equal to rise over run, the slope is proportional to the rise in pressure between the peak and valley; Figs. 4 and 6-7, note that when the peak of the graph is higher, the time period that the higher pressure is maintained is longer than scenarios where the higher pressure is lower, and thus, the hold time of the lower positive pressure decreases relative to its percent of the entire respiratory cycle as the higher therapy pressure level increases and the difference is greater).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Colbaugh such that the pressure decreases proportionally to the therapy positive airway pressure, as taught by Mechlenberg, in order to gradually increase the pressure values between their peaks and valleys which helps to improve patient comfort.
Regarding claim 37, Colbaugh discloses the method of claim 33, as discussed above.
Colbaugh fails to discloses wherein the pressure decreases proportionally to a difference between the relief positive airway pressure and the therapy positive airway pressure.
However, Mechlenberg teaches a method of providing bi-level positive pressure support therapy (paragraph 42, lines 1-4; Fig. 4), wherein the pressure decreases proportionally to a difference between the lower positive airway pressure and the higher positive airway pressure in order to facilitate gradual increase of the pressure values between their peaks and valleys which helps to improve patient comfort (paragraph 22, lines 16-25, note use of the term “gradual” and “straight lines (fixed rates”, indicating that a constant slope for the transitions is contemplated, and being that slope is equal to rise over run, the slope is proportional to the rise in pressure between the peak and valley, which is equivalent to the difference in each pressure level; Figs. 4 and 6-7, note that when the peak of the graph is higher, the time period that the higher pressure is maintained is longer than scenarios where the higher pressure is lower, and thus, the hold time of the lower positive pressure decreases relative to its percent of the entire respiratory cycle as the higher therapy pressure level increases and the difference is greater).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Colbaugh such that wherein the pressure increases proportionally to a difference between the relief positive airway pressure and the therapy positive airway pressure, as taught by Mechlenberg, in order to gradually increase the pressure values between their peaks and valleys which helps to improve patient comfort.
Regarding claim 44, Colbaugh discloses the method of claim 43, as discussed above.
Colbaugh fails to disclose wherein the period of time the therapy positive airway pressure is maintained is proportional to a difference between the relief positive airway pressure and the therapy positive airway pressure, such that, when the difference is greater, the therapy positive airway pressure is maintained for more time before the end of the exhalation period.
However, Mechlenberg teaches a method of providing bi-level positive pressure support therapy (paragraph 42, lines 1-4; Fig. 4), wherein the period of time the higher positive airway pressure is maintained is proportional to a difference between the lower positive airway pressure and the higher positive airway pressure, such that, when the difference is greater, the higher positive airway pressure is maintained for more time in order to gradually increase the pressure values between their peaks and valleys which helps to improve patient comfort (paragraph 22, lines 16-25, note use of the term “gradual” and “straight lines (fixed rates”, indicating that a constant slope for the transitions is contemplated; Figs. 4 and 6-7, note that when the peak of the graph is higher, the time period that the higher pressure is maintained is longer than scenarios where the higher pressure is lower, and thus, the hold time of the higher therapy pressure increases as the higher therapy pressure level increases).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Colbaugh to have the period of time the therapy positive airway pressure is maintained be proportional to a difference between the relief positive airway pressure and the therapy positive airway pressure, such that, when the difference is greater, the therapy positive airway pressure is maintained for more time before the end of the exhalation period, as taught by Mechlenberg, in order to gradually increase the pressure values between their peaks and valleys which helps to improve patient comfort.
Regarding claim 45, Colbaugh in view of Mechlenberg disclose the method of claim 44, as discussed above.
Presently modified Colbaugh fails to disclose wherein the period of time the relief positive airway pressure is maintained is proportional to a difference between the relief positive airway pressure and the therapy positive airway pressure, such that, when the difference is greater, the relief positive airway pressure is maintained for less time before the end of the exhalation period.
However, Mechlenberg further teaches a method of providing bi-level positive pressure support therapy (paragraph 42, lines 1-4; Fig. 4), wherein the period of time the lower positive airway pressure is maintained is proportional to a difference between the lower positive airway pressure and the higher positive airway pressure, such that, when the difference is greater, the lower positive airway pressure is maintained for less time in order to facilitate gradual increase and decrease of the pressure values between their peaks and valleys which helps to improve patient comfort (paragraph 22, lines 16-25, note use of the term “gradual” and “straight lines (fixed rates”, indicating that a constant slope for the transitions is contemplated; Figs. 4 and 6-7, note that when the peak of the graph is higher, the time period that the higher pressure is maintained is longer than scenarios where the higher pressure is lower, and thus, the hold time of the lower positive pressure decreases relative to its percent of the entire respiratory cycle as the higher therapy pressure level increases and the difference is greater).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Colbaugh to have the period of time the relief positive airway pressure is maintained be proportional to a difference between the relief positive airway pressure and the therapy positive airway pressure, such that, when the difference is greater, the relief positive airway pressure is maintained for less time before the end of the exhalation period, as taught by Mechlenberg, in order to gradually increase and decrease the pressure values between their peaks and valleys which helps to improve patient comfort.
Regarding claim 46, Colbaugh in view of Mechlenberg disclose the method of claim 44, as discussed above.
Colbaugh further discloses wherein the pressure increases from the relief positive airway pressure to the therapy positive airway pressure at least 0.5 seconds after the beginning of the exhalation period (Fig. 7; paragraph 38, lines 8-11; paragraph 42, lines 1-5).
Claims 16 and 32 are rejected under 35 U.S.C. 103 as being unpatentable over Colbaugh (US 2014/0109910), as applied to claims 5 and 1 respectively above, in view of Colbaugh (US 2019/0183417), hereinafter referred to as Colbaugh ‘417.
Regarding claim 16, Colbaugh discloses the method of claim 5, as discussed above.
While Colbaugh discloses the therapy positive airway pressure and the period of time the therapy positive airway pressure is maintained (see each of Figs. 4-7), Colbaugh fails to disclose that these variables are configured to maintain the patient's airway so as to avoid obstructive events.
However, Colbaugh ‘417 teaches that bi-level PAP treatments are configured to maintain the patient's airway so as to avoid obstructive events, such that normal respiration is maintained (paragraph 38, lines 5-12, see “free of apneas and hypopneas” and “stable and/or unobstructed”).
Therefore, it would have been obvious to one of ordinary sill in the art before the effective filing date of the claimed invention to have modified the method of Colbaugh such that the therapy positive airway pressure and its maintenance time were selected and configured to maintain the patient's airway so as to avoid obstructive events, as taught by Colbaugh ‘417, in order to maintain normal patient respiration during treatment.
Regarding claim 32, Colbaugh discloses the method of claim 1, as discussed above.
Colbaugh fails to disclose wherein, during the inhalation period, the pressure decreases from the therapy positive airway pressure to the relief positive airway pressure instantaneously.
However, Colbaugh ‘417 teaches wherein, during the inhalation period (see 43, 45, and 47 in Fig. 3), the pressure decreases from the therapy positive airway pressure to the relief positive airway pressure instantaneously (see 43, 45, and 47 in Fig. 3, where at the onset of inhalation, the square wave drops instantaneously from the higher pressure during exhalation to the lower inhalation pressure; paragraph 54, lines 1-24).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Colbaugh to have the decrease from the therapy positive pressure to the relief positive pressure happen instantaneously resulting from a square wave control pattern, as taught by Colbaugh ‘417, such that immediately upon a breathing cycle changing from exhalation to inhalation, the bi-level pressure change were configured to occur and accommodate the change in breathing.
Claim 26 is rejected under 35 U.S.C. 103 as being unpatentable over Colbaugh (US 2014/0109910), as applied to claim 1 above, in view of Romano (US 2019/0290869).
Regarding claim 26, Colbaugh discloses the method of claim 1, as discussed above.
Colbaugh fails to disclose wherein the relief positive airway pressure is configured to reduce mean airway pressure and thus improve comfort of the patient.
However, Romano teaches wherein the relief positive airway pressure is configured to reduce mean airway pressure and thus improve comfort of the patient (paragraph 32, lines 1-5).
Therefore, it would have been obvious to one of ordinary skill in the art that the reduced relief positive airway pressure of the method of Colbaugh is configured to reduce mean airway pressure and thus improve comfort of the patient, as taught by Romano, since Romano specifically teaches that the reduction in supplied inspiratory pressure consequently decreases mean airway pressure to increase patient comfort.
Claims 28 and 34 are rejected under 35 U.S.C. 103 as being unpatentable over Colbaugh (US 2014/0109910), as applied to claims 27 and 33 above, in view of Gray (US 2024/0033456).
Regarding claim 28, Colbaugh discloses the method of claim 27, as discussed above.
Colbaugh fails to disclose wherein the pressure increases according to a sigmoidal function.
However, Gray teaches a pressure increase within a respiratory system that follows a sigmoidal function in order to allow for a pressure increase to occur without the controller subsequently reducing flow and to enable modulation of gas flow at variable rates (paragraph 249, lines 1-8 and paragraph 253, lines 13-18).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Colbaugh to provide an increase in pressure according to a sigmoidal function, as taught by Gray, in order to allow for a pressure increase to occur without the controller subsequently reducing flow and to enable modulation of gas flow at variable rates.
Regarding claim 34, Colbaugh discloses the method of claim 33, as discussed above.
Colbaugh fails to disclose wherein the pressure decreases according to a sigmoidal function.
However, Gray teaches a pressure increase within a respiratory system that follows a sigmoidal function in order to allow for a pressure increase to occur without the controller subsequently reducing flow and to enable modulation of gas flow at variable rates (paragraph 249, lines 1-8 and paragraph 253, lines 13-18, see increase and decrease).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Colbaugh to provide a decrease in pressure according to a sigmoidal function, as taught by Gray, in order to allow for a pressure decrease to occur without the controller subsequently changing flow and to enable modulation of gas flow at variable rates.
Claims 29 and 35 are rejected under 35 U.S.C. 103 as being unpatentable over Colbaugh (US 2014/0109910), as applied to claims 27 and 33 above, in view of Estes (US 5,535,738).
Regarding claim 29, Colbaugh discloses the method of claim 27, as discussed above.
Colbaugh fails to disclose wherein the pressure increases proportionally to an air flow in the patient's airway.
However, Estes teaches a method of delivering bi-level pressure support to a patient (Col. 8, line 54-Col. 9, line 15; Fig. 3) wherein the pressure increases proportionally to an air flow in the patient's airway in order to increase patient comfort (Col. 11, lines 12-16; Fig. 3; Col. 7, lines 56-59).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Colbaugh such that the therapy positive airway pressure and the relief positive airway pressure were delivered such that the pressure increases proportionally to an air flow in the patient's airway, as taught by Estes, in order to enhance patient comfort during treatment.
Regarding claim 35, Colbaugh discloses the method of claim 33, as discussed above.
Colbaugh fails to disclose wherein the pressure increases proportionally to an air flow in the patient's airway.
However, Estes teaches a method of delivering bi-level pressure support to a patient (Col. 8, line 54-Col. 9, line 15; Fig. 3) wherein the pressure decreases proportionally to an air flow in the patient's airway in order to increase patient comfort (Col. 11, lines 12-16; Fig. 3; Col. 7, lines 56-59).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Colbaugh such that the therapy positive airway pressure and the relief positive airway pressure were delivered such that the pressure decreases proportionally to an air flow in the patient's airway, as taught by Estes, in order to enhance patient comfort during treatment.
Claims 38-42 are rejected under 35 U.S.C. 103 as being unpatentable over Colbaugh (US 2014/0109910), as applied to claim 33 above, in view of Rapoport (US 2019/0255272).
Regarding claim 38, Colbaugh discloses the method of claim 33, as discussed above.
Colbaugh fails to disclose wherein, during the relief transition period, the pressure provided within the patient's airway decreases from the therapy positive airway pressure an initial amount before maintaining substantially constant at an intermediate pressure and subsequently decreasing in one or more additional steps from the intermediate pressure to the relief positive airway pressure.
However, Rapoport teaches a step-wise change in provided pressure during a period where delivered pressure is set to decrease, such that the pressure decreases an initial amount before maintaining a constant level at an intermediate pressure and then decreasing to a final pressure (paragraph 184, final four lines; paragraph 185, lines 1-3 and Fig. 9 to establish an illustration of the “stepped” change in an increasing pressure profile, note Fig. 9A, which includes an initial pressure, a stepped increase and hold, another stepped increase which would coincide with the intermediate pressure, and finally, the last pressure increase) in order to allow the lungs to reach functional residual capacity between breaths (paragraph 175, lines 10-16).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Colbaugh such that during the relief transition period, the pressure provided within the patient's airway decreases from the therapy positive airway pressure an initial amount before maintaining substantially constant at an intermediate pressure and subsequently decreasing in one or more additional steps from the intermediate pressure to the relief positive airway pressure, as taught by Rapoport, in order to allow the lungs to reach functional residual capacity between breaths, and as a known alternative waveform shape when decreasing pressure support between multiple levels.
Regarding claim 39, Colbaugh in view of Rapoport disclose the method of claim 38, as discussed above.
Presently modified Colbaugh fails to disclose wherein the pressure provided within the patient's airway decreases the initial amount of between about 2 cmH2O and about 4 cmH2O.
However, Rapoport further teaches wherein the pressure provided within the patient's airway decreases the initial amount of between about 3 cmH2O and about 5 cmH2O in order to affect a change in lung volume by a controlled amount (paragraph 158, lines 37-41; paragraph 184, final four lines).
In the case where the claimed range is overlapped or lies within the range disclosed by the prior art, a prima facie case of obviousness exists (see MPEP 2144.05 I). In the instant case, the disclosed range of 3-5 cm H2O overlaps the claimed range of 2 cmH2O and about 4 cmH2O, and thus the range claimed is prima facie obvious in light of Rapoport’s teachings.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided the stepped pressure decrease in the range of 3 cmH2O and about 5 cmH2O, as taught by Rapoport, in order to affect a change in lung volume by a controlled amount.
Regarding claim 40, Colbaugh in view of Rapoport disclose the method of claim 38, as discussed above.
Presently modified Colbaugh fails to disclose wherein a particular range that the pressure provided within the patient's airway decreases the initial amount.
However, Rapoport further teaches wherein the pressure provided within the patient's airway decreases the initial amount of between about 3 cmH2O and about 5 cmH2O in order to affect a change in lung volume by a controlled amount (paragraph 158, lines 37-41; paragraph 184, final four lines).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided the stepped pressure decrease in the range of 3 cmH2O and about 5 cmH2O, as taught by Rapoport, in order to affect a change in lung volume by a controlled amount.
Given that Colbaugh provides various differences between the therapy positive airway pressure and the relief positive airway pressure, to include 16 cmH2O (see Fig. 4), and 8 cmH2O (see Figs. 5-7), and the initial decrease as modified lies within the range of 3-5 cmH2O, modified Colbaugh contemplates wherein the pressure provided within the patient's airway decreases the initial amount of between about 20% and about 50% of a difference between the relief positive airway pressure and the therapy positive airway pressure, since a pressure change of 4-5 cmH2O under the 16 cmH2O difference condition equates to 25% and 31.25% respectively, and a pressure change of 3-4 cmH2O under the 8 cmH2O difference condition equates to 37.5% and 50% respectively.
Regarding claim 41, Colbaugh in view of Rapoport disclose the method of claim 38, as discussed above.
Modified Colbaugh further discloses wherein the pressure provided within the patient's airway decreases from the intermediate pressure to the relief positive airway pressure after peak inhalation flow (note the breath cycles in each of Colbaugh’s Figs. 4-7, and the identified therapy and relief pressures in claim 1, as well as the pressure step profile evidenced in Rapoport’s Fig. 9 and Rapoport’s teaching in the final four lines of paragraph 184; given that multiple breath cycles occur, and as modified the pressure increase/decrease occurs over a single respiration cycle, the decrease from intermediate to relief pressure occurs after the prior respiration’s inhalation peak; note this interpretation and application of art may be overcome by specifying the inhalation peak within the same breath cycle).
Regarding claim 42, Colbaugh in view of Rapoport disclose the method of claim 41, as discussed above.
Modified Colbaugh further discloses wherein the pressure provided within the patient's airway decreases from the intermediate pressure to the relief positive airway pressure before peak exhalation flow (note the breath cycles in each of Colbaugh’s Figs. 4-7, and the identified therapy and relief pressures in claim 1, as well as the pressure step profile evidenced in Rapoport’s Fig. 9 and Rapoport’s teaching in the final four lines of paragraph 184; given that multiple breath cycles occur, and as modified the pressure increase/decrease occurs over a single respiration cycle, the decrease from intermediate to relief pressure occurs before the subsequent respiration’s exhalation peak; note this interpretation and application of art may be overcome by specifying the inhalation peak within the same breath cycle).
Claim 50 is rejected under 35 U.S.C. 103 as being unpatentable over Colbaugh (US 2014/0109910), as applied to claim 33 above, in view of Carter (US 2008/0202528).
Regarding claim 50, Colbaugh discloses the system of claim 49, as discussed above.
Colbaugh further discloses wherein the patient interface (184) is a full face mask, a partial face mask, or a nasal pillow (paragraph 20, lines 14-17).
Colbaugh fails to disclose wherein the relief positive airway pressure, the therapy positive airway pressure, or both the relief positive airway pressure and the therapy positive airway pressure are adjusted depending on the type of patient interface connected to the patient's respiratory system.
However, Carter teaches a comfort feature function (66) which controls a level of pressure support in the respiratory system (paragraph 45, lines 1-9; paragraph 47, lines 1-13), wherein the comfort feature function (66) can be modified based on the type of patient interface attached to the system (paragraphs 69 and 74).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Colbaugh to include a comfort feature function, as taught by Carter, in order to adjust the relief positive airway pressure, the therapy positive airway pressure, or both the relief positive airway pressure and the therapy positive airway pressure depending on the type of patient interface connected to the patient's respiratory system in order to enhance and ensure patient comfort during treatment regardless of interface attachment.
Claims 47-48 are rejected under 35 U.S.C. 103 as being unpatentable over Colbaugh (US 2014/0109910) in view of Rapoport (US 2019/0255272).
Regarding claim 47, Colbaugh discloses a method for treating sleep disordered breathing (abstract, lines 1-5; paragraph 39, lines 1-13; paragraph 42, lines 1-5; Fig. 7), the method comprising:
providing pressure into a patient's airway over a period of time that includes a plurality of inhalation periods (2) and a plurality of exhalation periods (3) (paragraph 39, lines 1-13; paragraph 42, lines 1-5 and Fig. 7), the pressure varying between a lower relief positive airway pressure and a higher therapy positive airway pressure (see Fig. 7, where the pressure during inhalation periods 2 and prior to the peak in exhalation period 3 is regarded as the relief positive airway pressure, and the peak of the exhalation period 3 is regarded as the therapy positive airway pressure, where the peak of the pressure is higher than the remaining portions of the waveform);
wherein the pressure is at a relief positive airway pressure during a portion of the inhalation periods (2) including an end of the inhalation period (see Fig. 4, where the pressure during inhalation periods 2 ranges from a relief positive airway pressure of 0-12 cm H2O; see Figs. 5-7, where the pressure during inhalation periods 2 ranges from a relief positive airway pressure of 4-12 cm H2O);
wherein the pressure is at a therapy positive airway pressure during a portion of the exhalation periods (3) including an end of the exhalation period, the therapy positive airway pressure greater than the relief positive airway pressure (see Fig. 4, where the pressure during exhalation periods 3 ranges from a therapy positive airway pressure of 12-16 cm H2O; see Figs. 5-6, where the pressure during exhalation periods 3 is a therapy positive airway pressure of 12 cm H2O; see Fig. 7, where the pressure during exhalation periods 3 ramps up from 4 cm H2O to about 12 cm H2O; note that in each waveform, at least a portion of the exhalation period therapy positive pressure is greater than at least a portion of the inhalation period relief positive pressure, e.g. the peak pressure during exhalation in each waveform is greater than the lowest pressure during inhalation).
Colbaugh fails to disclose wherein, during a portion of the inhalation periods, the pressure is maintained substantially constant at an intermediate pressure less than the therapy positive airway pressure and greater than the relief positive airway pressure; and
wherein the pressure subsequently decreases from the intermediate pressure to the relief positive airway pressure.
However, Rapoport teaches a step-wise change in provided pressure during a period where delivered pressure is set to decrease, such that the pressure decreases an initial amount before maintaining a constant level at an intermediate pressure and then decreasing to a final pressure (paragraph 184, final four lines; paragraph 185, lines 1-3 and Fig. 9 to establish an illustration of the “stepped” change in an increasing pressure profile, note Fig. 9A, which includes an initial pressure, a stepped increase and hold, another stepped increase which would coincide with the intermediate pressure, and finally, the last pressure increase) in order to allow the lungs to reach functional residual capacity between breaths (paragraph 175, lines 10-16).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Colbaugh such that during a portion of the inhalation periods, the pressure is maintained substantially constant at an intermediate pressure less than the therapy positive airway pressure and greater than the relief positive airway pressure, and wherein the pressure subsequently decreases from the intermediate pressure to the relief positive airway pressure in one or more steps, as taught by Rapoport, in order to allow the lungs to reach functional residual capacity between breaths, and as a known alternative waveform shape when decreasing pressure support between multiple levels.
Regarding claim 48, Colbaugh in view of Rapoport disclose the method of claim 47, as discussed above.
Modified Colbaugh further discloses wherein the pressure provided within the patient's airway decreases from the intermediate pressure to the relief positive airway pressure after peak inhalation flow and before peak exhalation flow (note the breath cycles in each of Colbaugh’s Figs. 4-7, and the identified therapy and relief pressures in claim 1, as well as the pressure step profile evidenced in Rapoport’s Fig. 9 and Rapoport’s teaching in the final four lines of paragraph 184; given that multiple breath cycles occur, and as modified the pressure increase/decrease occurs over a single respiration cycle, the decrease from intermediate to relief pressure occurs after the prior respiration’s inhalation peak and the decrease from intermediate to relief pressure occurs before the subsequent respiration’s exhalation peak; note this interpretation and application of art may be overcome by specifying the inhalation peak within the same breath cycle).
Allowable Subject Matter
Claims 15 and 22-23 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.
Conclusion
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/PAIGE KATHLEEN BUGG/Primary Examiner, Art Unit 3785
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