DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. 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
2. This office action is responsive to the amendment filed on November 12, 2025. As directed by the amendment: claims 1, 4, 6-10, 13, and 15-20 have been amended, claim 14 has been cancelled, and no claims have been added. Thus, claims 1-13 and 15-20 are presently pending in this application.
Claim Interpretation
3. The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
4. The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
5. This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
“a force transmitting device (FTD)” in claim 2 lines 1-2 and claim 11 line 2 is interpreted as a belt, wrap vest, or the like according to specification paragraph [0084].
“a CO2 controller” in claim 5 line 1 is interpreted as a passive or active valve for venting gas near the interface or the like according to specification paragraph [0115].
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 112
6. The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-13 and 15-20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 1, the limitation “at least one sensor configured to sense air pressure and flow at the patient interface” in line 5 is unclear on how the claimed option of a single sensor would be able to measure both pressure and flow. The specification contemplates using multiple sensors to accomplish this in paragraph [0035] where a pressure sensor monitors pressure while a flow sensor monitors respiratory gas flow at the patient interface.
Regarding claims 1 and 10, the limitation “controlling the air source to deliver a low-level PAP until patient initiated inhalation is sensed via the at least one sensor, followed by, for a single insufflation phase, controlling the air source to first deliver a series of high-level PAP, followed by a low-level PAP” in claim 1 lines 15-19 and claim 10 lines 11-15 is unclear if the “low-level PAP” following the high level PAP is referring to the same low-level PAP delivered to the patient until the initiation of inhalation, or simply a pressure level that is low relative to the “high-level PAP”. The claim is being interpreted as though the two “low-level” PAPs are not required to be the same pressure levels.
Regarding claims 6 and 15, the limitation “deliver the MAC to the patient when both of a target breathing flow and a target inhalation time period are sensed by the at least one sensor” in claim 6 lines 2-4 and claim 15 lines 2-4 is unclear in how the MAC can be delivered after the breath pacing procedure which lasts until “an end of inhalation” (see claim 1 line 19 and claim 10 line 13) and also after a “target inhalation time period”. This claim is being interpreted as though the “target inhalation time period” is at the end of inhalation.
Claim 19 recites the limitation “the at least one sensor” in line 9. There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 20, the limitation “increasing a duration of the series of high-level PAP” in lines 4-5 is unclear. Delivering the MAC is based on the breath pacing procedure which spans a single insufflation and ends at the end of inhalation (see claim 19 line 12). However, the recited limitation suggests a controlled period of time is being used to deliver the MAC. Therefore, it is not clear if what is being used to deliver the MAC is the patient’s end of inhalation or a preset time period which is adjusted. The claim is being interpreted as relying on the patient’s end of inhalation.
Any remaining claims are rejected as being dependent upon a rejected based claim.
Claim Rejections - 35 USC § 103
7. 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.
8. 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.
9. Claims 1, 2, 5- 11, and 15- 20, as best understood, are rejected under 35 U.S.C. 103 as being unpatentable over Lee (US 2017/0333653) in view of Bobey et al. (US 2017/0027813) and Birnkrant et al. (US 2021/0008309).
Regarding claim 1, Lee discloses a mechanical insufflation-exsufflation (MI-E) device (fig. 1, system for the insufflation and exsufflation of a subject 10) that is configured to time delivery of a mechanically assisted cough ([0022] the pressure generator 14 can be controlled to quickly reduce pressure to remove mucus or other debris mimicking a cough) using a breath pacing procedure (defined as a controlled sequence of high and low pressures delivered in response to a patient initiated inhalation according to the specification paragraph [0019], Lee [0022] states that after expiration is complete, a first pressure is then resumed to initiate another in-exsufflation), comprising:
an air source (fig. 1, pressure generator 14) configured to provide patient airway pressure including positive airway pressure (PAP) (fig. 1, 14 provides a pressurized flow to the airway of a subject, see [0018]);
a patient interface coupled to the air source (fig. 1, interface 32 is coupled to generator 14 via conduit 30) and configured to be flow coupled to a user (fig. 1, interface 32 is coupled with subject 12, see [0023]));
at least one sensor configured to sense air pressure and flow at the patient interface (fig. 1, sensors 18, see [0025]); and
a controller coupled to the air source and the at least one sensor (fig. 1, processor 20 is connected with generator 14 and sensors 18), the controller being configured to control the air source to deliver the MAC ([0022] the pressure generator 14 can be controlled to quickly reduce pressure to remove mucus or other debris mimicking a cough) to the patient in response to the breath pacing procedure, the breath pacing procedure comprising:
controlling the air source to deliver a low-level PAP (fig. 5, step 502 creates an initial pressurized flow prior to inexsufflation therapy), the controller being configured to deliver the MAC after the end of inhalation ([0022] states that the pressure is reduced after insufflation) and following the breath pacing procedure (fig. 5, step 514 states that inexsufflation therapy can also be provided after an initial cycle).
Lee further discloses that during insufflation a first pressure is delivered ([0021]) at the end of exsufflation ([0022]), but fails to disclose that the breath pacing procedure includes a series of high-level PAP followed by a series of low-level PAP over the duration of a single insufflation phase and does not expressly disclose that patient initiated inhalation is sensed and an end of inhalation is sensed.
Regarding the series of high-level PAP followed by a series of low-level PAP over the duration of a single insufflation phase, Bobey teaches a respiratory therapy apparatus that uses a controller to provide oscillations to the positive insufflation pressure ([0007] discloses applying oscillations to the positive insufflation pressure, wherein such oscillations are considered “a series of high level PAP followed by a series of low-level PAP”).
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to replace the program of Lee which generates a positive pressure (Lee [0022]) with the program as taught by Bobey which generates a positive insufflation pressure with oscillations (Bobey [0007]) as a simple substitution of one known element for another to obtain a predictable result of assisting insufflation of the patient’s lungs.
Regarding the sensing of a patient-initiated inhalation and the sensing of an end of inhalation, Birnkrant teaches of a respiratory therapy management system for ventilation and cough assistance ([0004]) that can ventilate the lungs by detecting a beginning and end of inhalation ([0052]).
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to replace the program for a predetermined insufflation time of Lee (Lee [0003]) with the program for detecting a beginning and end of inhalation as taught by Birnkrant as a simple substitution of one known element for another to obtain a predictable result of providing an assistive pressure during inhalation. Such a modification further provides accurate start and stopping times for inhalation in order to execute the steps of the cough assist maneuver.
The modified device of Lee further reads on the limitations of the breath pacing procedure includes a series of high-level PAP (Bobey fig. 3, insufflation mode 202 has a high pressure at each oscillation peak) followed by a series of low-level PAP over the duration of a single insufflation phase (Bobey fig. 3, insufflation mode 202 has a low pressure at each oscillation trough) over a single insufflation phase which begins when patient initiated inhalation is sensed via the at least one sensor (Birnkrant [0052]) until an end of inhalation is sensed via the at least one sensor (Birnkrant [0052]).
Regarding claim 2, the modified device of Lee reads on the limitations of claim 1, but is silent on a force transmitting device coupled to the controller which applies an abdominal thrust synchronized to the MAC.
However, Bobey teaches of a respiratory therapy apparatus for providing mechanical insufflation/exsufflation therapy to a patient (fig. 1) that uses a high frequency chest wall oscillator (fig. 1) which includes a vest (fig. 1, 12) that is fed air to apply a compressive force to the patient ([0023]) that is synced to a negative exsufflation pressure ([0041]).
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to provide the device of Lee with the controls and vest as taught by Bobey for the purpose of producing a more productive cough using a combination of negative pressure and a squeeze to the torso of the patient (Bobey [0041]).
Regarding claim 5, the modified device of Lee reads on the limitations of claim 1 and further reads on a CO2 controller (Lee [0024] states subject interface 16 includes a second limb to selectively exhaust gas) coupled to the patient interface (Lee [0024] states that the second limb can exhaust exhaled gases which inherently means it is in communicating with the patient interface which is where the exhaled gases originate) and configured to control a concentration of CO2 gas at the patient interface (Lee [0024] states the second limb can exhaust exhaled gases which limits CO2 buildup which originates at the patient interface, meaning it is controlling the concentration of CO2 at the patient interface).
Regarding claim 6, the modified device of Lee reads on the limitations of claim 1 and further reads on the controller is configured to control the air source (Lee fig. 1, controller 20 can control pressure generator 14, see [0031]) to deliver the MAC (Lee [0022] the pressure generator 14 can be controlled to quickly reduce pressure to remove mucus or other debris mimicking a cough) to the patient when both of a target breathing flow and a target inhalation time period are sensed by the at least one sensor (Lee [0022] states that the abrupt pressure reduction is performed after insufflation, which is after inhalation ends and is detected by Birnkrant [0052]).
Regarding claim 7, the modified device of Lee reads on the limitations of claim 1 and further reads on the controller (Lee fig. 1, processor 20 includes 22, 24, and 26) is configured to only continue the high-level PAP responsive to determining that inhalation continues (Birnkrant [0052] states that a beginning of inhalation is detected and then supported until an end of inhalation is detected, therefore high-level PAP is provided while inhalation continues).
Regarding claim 8, the modified device of Lee reads on the limitations of claim 1 and further reads on that the controller is configured to increase a duration of the series of high-level PAP by a predetermined period of time (Lee [0039] states that control component 26, which is part of processor 20, can increase the insufflation time).
Regarding claim 9, the modified device of Lee reads on the limitations of claim 1 and further reads on that the controller is configured to increase the pressure of the series of high-level PAP by a predetermined pressure (Lee [0039] states that control component 26, which is part of processor 20, can increase the insufflation pressure).
Regarding claim 10, Lee discloses a mechanical insufflation-exsufflation (MI-E) device (fig. 1, system for the insufflation and exsufflation of a subject 10) that is configured to time delivery of a mechanically assisted cough ([0022] the pressure generator 14 can be controlled to quickly reduce pressure to remove mucus or other debris mimicking a cough) using a breath pacing procedure (defined as a controlled sequence of high and low pressures delivered in response to a patient initiated inhalation according to the specification paragraph [0019], Lee [0022] states that after expiration is complete, a first pressure is then resumed to initiate another in-exsufflation), comprising:
a controller configured to control an air source (fig. 1, processor 20 is connected with generator 14 and sensors 18) to deliver the MAC ([0022] the pressure generator 14 can be controlled to quickly reduce pressure to remove mucus or other debris mimicking a cough) to the patient in response to the breath pacing procedure, the breath pacing procedure comprising:
controlling the air source to deliver a low-level PAP (fig. 5, step 502 creates an initial pressurized flow prior to inexsufflation therapy), the controller being configured to deliver the MAC after the end of inhalation ([0022] states that the pressure is reduced after insufflation) and following the breath pacing procedure (fig. 5, step 514 states that inexsufflation therapy can also be provided after an initial cycle).
Lee further discloses that during insufflation a first pressure is delivered ([0021]) at the end of exsufflation ([0022]), but fails to disclose that the breath pacing procedure includes a series of high-level PAP followed by a series of low-level PAP over the duration of a single insufflation phase and does not expressly disclose that patient initiated inhalation is sensed and an end of inhalation is sensed.
Regarding the series of high-level PAP followed by a series of low-level PAP over the duration of a single insufflation phase, Bobey teaches of a respiratory therapy apparatus that uses a controller to provide oscillations to the positive insufflation pressure ([0007]).
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to replace the program of Lee which generates a first pressure (Lee [0022]) with the program as taught by Bobey which generates a positive insufflation pressure with oscillations (Bobey [0007]) as a simple substitution of one known element for another to obtain a predictable result of assisting insufflation of the patient’s lungs.
Regarding the sensing of a patient initiated inhalation and the sensing of an end of inhalation, Birnkrant teaches of a respiratory therapy management system for ventilation and cough assistance ([0004]) that can ventilate the lungs by detecting a beginning and end of inhalation ([0052]).
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to replace the program for a predetermined insufflation time of Lee (Lee [0003]) with the program for detecting a beginning and end of inhalation as taught by Birnkrant as a simple substitution of one known element for another to obtain a predictable result of providing an assistive pressure during inhalation.
The modified device of Lee further reads on the limitations of the breath pacing procedure includes a series of high-level PAP (Bobey fig. 3, insufflation mode 202 has a high pressure at each oscillation peak) followed by a series of low-level PAP over the duration of a single insufflation phase (Bobey fig. 3, insufflation mode 202 has a low pressure at each oscillation trough) over a single insufflation phase which begins when patient initiated inhalation is sensed via the at least one sensor (Birnkrant [0052]) until an end of inhalation is sensed via the at least one sensor (Birnkrant [0052]).
Regarding claim 11, the modified device of Lee discloses the limitations of claim 10, but is silent on a force transmitting device coupled to the controller which applies an abdominal thrust synchronized to the MAC.
However, Bobey teaches of a respiratory therapy apparatus for providing mechanical insufflation/exsufflation therapy to a patient (fig. 1) that uses a high frequency chest wall oscillator (fig. 1) which includes a vest (fig. 1, 12) that is fed air to apply a compressive force to the patient ([0023]) that is synced to a negative exsufflation pressure ([0041]).
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to provide the device of Lee with the controls and vest as taught by Bobey for the purpose of producing a more productive cough using a combination of negative pressure and a squeeze to the torso of the patient (Bobey [0041]).
The modified device of Lee includes a force transmitting device (Bobey fig. 1, vest 12) to apply an abdominal thrust (Bobey [0023] states air is fed into the vest to apply a compressive force) that is synchronized to the MAC (Bobey [0041] states the squeeze applied to the torso is synced with the negative exsufflation pressure in the patient’s airway).
Regarding claim 15, the modified device of Lee reads on the limitations of claim 10 and further reads on the controller configured to control the air source (Lee fig. 1, controller 20 can control pressure generator 14, see [0031]) to deliver the MAC (Lee [0022] the pressure generator 14 can be controlled to quickly reduce pressure to remove mucus or other debris mimicking a cough) to the patient when both of a target breathing flow and a target inhalation time period are sensed by the at least one sensor (Lee [0022] states that the abrupt pressure reduction is performed after insufflation, which is after inhalation ends and is detected by Birnkrant [0052]).
Regarding claim 16, the modified device of Lee reads on the limitations of claim 10 and further reads on the controller (Lee fig. 1, processor 20 includes 22, 24, and 26) is configured to only continue the high-level PAP responsive to determining that inhalation continues (Birnkrant [0052] states that a beginning of inhalation is detected and then supported until an end of inhalation is detected, therefore high-level PAP is provided while inhalation continues).
Regarding claim 17, the modified device of Lee reads on the limitations of claim 10 and further reads on the controller is configured to increase a duration of the series of high-level PAP by a predetermined period of time (Lee [0039] states that control component 26, which is part of processor 20, can increase the insufflation time).
Regarding claim 18, the modified device of Lee reads on the limitations of claim 10 and further reads on the controller is configured to increase the pressure of the series of high-level PAP by a predetermined pressure (Lee [0039] states that control component 26, which is part of processor 20, can increase the insufflation pressure).
Regarding claim 19, Lee discloses a method of controlling a mechanical insufflation-exsufflation (MI-E) device (Lee fig. 5) to time delivery of a mechanically assisted cough (MAC) using a breath pacing procedure (Lee fig. 5, step 510 delivers the first inexsufflation therapy regime), the method comprising:
Controlling an air source to deliver the MAC ([0022] the pressure generator 14 can be controlled to quickly reduce pressure to remove mucus or other debris mimicking a cough) to the patient in response to the breath pacing procedure, the breath pacing procedure comprising:
controlling the air source to deliver a low-level PAP (fig. 5, step 502 creates an initial pressurized flow prior to inexsufflation therapy), the controller being configured to deliver the MAC after the end of inhalation ([0022] states that the pressure is reduced after insufflation) and following the breath pacing procedure (fig. 5, step 514 states that inexsufflation therapy can also be provided after an initial cycle).
Lee further discloses that during insufflation a first pressure is delivered ([0021]) at the end of exsufflation ([0022]), but fails to disclose that the breath pacing procedure includes a series of high-level PAP followed by a series of low-level PAP over the duration of a single insufflation phase and does not expressly disclose that patient initiated inhalation is sensed and an end of inhalation is sensed.
Regarding the series of high-level PAP followed by a series of low-level PAP over the duration of a single insufflation phase, Bobey teaches of a respiratory therapy method that provides oscillations to the positive insufflation pressure ([0007]).
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to replace the program of Lee which generates a first pressure (Lee [0022]) with the program as taught by Bobey which generates a positive insufflation pressure with oscillations (Bobey [0007]) as a simple substitution of one known element for another to obtain a predictable result of assisting insufflation of the patient’s lungs.
Regarding the sensing of a patient initiated inhalation and the sensing of an end of inhalation, Birnkrant teaches of a respiratory therapy management system for ventilation and cough assistance ([0004]) that can ventilate the lungs by detecting a beginning and end of inhalation ([0052]).
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to replace the program for a predetermined insufflation time of Lee (Lee [0003]) with the program for detecting a beginning and end of inhalation as taught by Birnkrant as a simple substitution of one known element for another to obtain a predictable result of providing an assistive pressure during inhalation.
The modified method of Lee further reads on the limitations of the breath pacing procedure includes a series of high-level PAP (Bobey fig. 3, insufflation mode 202 has a high pressure at each oscillation peak) followed by a series of low-level PAP over the duration of a single insufflation phase (Bobey fig. 3, insufflation mode 202 has a low pressure at each oscillation trough) over a single insufflation phase which begins when patient initiated inhalation is sensed via the at least one sensor (Birnkrant [0052]) until an end of inhalation is sensed via the at least one sensor (Birnkrant [0052]).
Regarding claim 20, the modified method of Lee reads on the limitations of claim 19 and further reads on the act of controlling the air source to deliver the MAC to the patient comprises at least one of increasing a duration of the series of high-level PAP by a predetermined period of time (Birnkrant [0052] detects an end of inhalation) and increasing the pressure of the series of high-level PAP by a predetermined pressure (Lee [0039] states that control component 26 can increase the insufflation pressure).
10. Claim(s) 3-4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lee in view of Bobey and Birnkrant as applied to claim 1 above, and further in view of Lee (US 2018/0243521) hereinafter ‘521.
Regarding claim 3, the modified device of Lee reads on the limitations of claim 1 and further reads on the controller is configured to receive flow and pressure information from the at least one sensor (Lee [0025] states that sensors 18 includes sensors for measuring a flow rate and pressure, the controller tracks the volume which is integrally related to flow), and that the pressure is monitored between a first and second pressure (Lee [0021]-[0022]). Lee does not expressly disclose that the device creates a flow and pressure waveform.
However, ‘521 teaches of a device which synchronizes a patient’s cough with a mechanical insufflation-exsufflation device (fig. 1, 10) by monitoring pressure and volume values (fig. 2 shows the pressure waveform, fig. 3, shows the flow waveform, [0023] states that parameters of the pressure waveform assist in cough synchronization, and [0052] states that the flow rate can also initiate cough synchronization).
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to provide the controls for measuring and synchronizing a patient’s cough (‘521 fig. 1, processor 20) to the device of Lee as taught by ‘521 for the purpose of improving the accuracy of the synchronization between the patient and the device (‘521 [0005]-[0006]) via pressure and flow waveforms.
Regarding claim 4, the modified device of Lee reads on the limitations of claim 3 and further reads on the series of high-level PAP (Lee [0022] states that after insufflation, the pressure drops from a first pressure to a second pressure during exsufflation; after which, the pressure may return to the first pressure level to start inspiration) is delivered in response to detecting an inhalation trigger in a form of a change in pressure below ambient in the pressure waveform (Birnkrant [0052] states that a patient generated negative pressure is used to detect the start of inhalation).
11. Claim(s) 12-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lee in view of Bobey and Birnkrant as applied to claim 10 above, and further in view of ‘521.
Regarding claim 12, the modified device of Lee reads on the limitations of claim 10 and further reads on the controller is configured to receive flow and pressure information from the at least one sensor (Lee [0025] states that sensors 18 includes sensors for measuring a flow rate and pressure, the controller tracks the volume which is integrally related to flow), and that the pressure is monitored between a first and second pressure (Lee [0021]-[0022]). Lee does not expressly disclose that the device creates a flow and pressure waveform.
However, ‘521 teaches of a device which synchronizes a patient’s cough with a mechanical insufflation-exsufflation device (fig. 1, 10) by monitoring pressure and volume values (fig. 2 shows the pressure waveform, fig. 3, shows the flow waveform, [0023] states that parameters of the pressure waveform assist in cough synchronization, and [0052] states that the flow rate can also initiate cough synchronization).
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to provide the controls for measuring and synchronizing a patient’s cough (‘521 fig. 1, processor 20) to the device of Lee as taught by ‘521 for the purpose of improving the accuracy of the synchronization between the patient and the device (‘521 [0005]-[0006]) via pressure and flow waveforms.
Regarding claim 13, the modified device of Lee reads on the limitations of claim 12 and further reads on the series of high-level PAP (Lee [0022] states that after insufflation, the pressure drops from a first pressure to a second pressure during exsufflation; after which, the pressure may return to the first pressure level to start inspiration) is delivered in response to detecting an inhalation trigger in a form of a change in pressure below ambient in the pressure waveform (Birnkrant [0052] states that a patient generated negative pressure is used to detect the start of inhalation).
Response to Arguments
12. Applicant’s arguments with respect to claim(s) 1-13 and 15-20 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
13. The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Emerson (US 2005/0039749) discloses an insufflation-exsufflation system that senses inhalation an automatically triggers an inhalation phase. Brand et al. (US 2012/0111329) discloses a cough assisting device that uses an oscillation inhalation and exhalation airflow.
14. Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
15. Any inquiry concerning this communication or earlier communications from the examiner should be directed to THOMAS Z CHANG whose telephone number is (571)272-0432. The examiner can normally be reached Monday-Friday 9:00 am-5:00 pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Timothy Stanis can be reached at (571)272-5139. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/THOMAS Z CHANG/ Examiner, Art Unit 3785
/TIMOTHY A STANIS/ Supervisory Patent Examiner, Art Unit 3785
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