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 .
Specification
Applicant is reminded of the proper content of an abstract of the disclosure.
A patent abstract is a concise statement of the technical disclosure of the patent and should include that which is new in the art to which the invention pertains. The abstract should not refer to purported merits or speculative applications of the invention and should not compare the invention with the prior art.
If the patent is of a basic nature, the entire technical disclosure may be new in the art, and the abstract should be directed to the entire disclosure. If the patent is in the nature of an improvement in an old apparatus, process, product, or composition, the abstract should include the technical disclosure of the improvement. The abstract should also mention by way of example any preferred modifications or alternatives.
Where applicable, the abstract should include the following: (1) if a machine or apparatus, its organization and operation; (2) if an article, its method of making; (3) if a chemical compound, its identity and use; (4) if a mixture, its ingredients; (5) if a process, the steps.
Extensive mechanical and design details of an apparatus should not be included in the abstract. The abstract should be in narrative form and generally limited to a single paragraph within the range of 50 to 150 words in length.
See MPEP § 608.01(b) for guidelines for the preparation of patent abstracts.
The abstract of the disclosure is objected to because it is less than 50 words and contains the phrase “The disclosure relates to” which can be implied. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
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 for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 3, 4, 6, 8-14, 16, and 18-20 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Truschel et al. (US 2024/0091473).
As to claim 1, Truschel discloses a system, comprising:
a respiratory device 10 (ventilator system 10, Fig. 1, paragraph [0053]) configured to deliver fluid to a patient, wherein the respiratory device 10 is operable in a mechanical cough mode (mucus clearing system 100, Fig. 3; parameter controller for mucus clearance mode, Fig. 5, paragraph [0059]); and
a controller (processing unit 30, Fig. 3, paragraph [0053]; parameter controller for mucus clearance mode, Fig. 5, paragraph [0059]) configured to issue one or more commands to the respiratory device 10 such that, during an insufflation phase of the mechanical cough mode, (i) a flow rate of the fluid conducted to the patient by the respiratory device 10 is substantially constant throughout the insufflation phase, or (ii) a flow rate of the fluid conducted to the patient by the respiratory device gradually increases throughout the insufflation phase (Truschel discloses scenario (ii) in Fig. 6D. 4 and paragraph [0064], the rise time and inspiratory time has been increased so that the rise time for the flow (and pressure) is equal to about 1.6 seconds (which is the length of the insufflation phase) before the flow is reversed and the exsufflation phase begins. The effect is a slower gradual increase in flow over the course of the insufflation phase as compared to the initial setting in Fig. 6D.2 where the flow rises fairly quickly and falls slightly before the exsufflation phase begins).
As to claim 3, Truschel discloses the system as recited in claim 1, wherein, during the insufflation phase of the mechanical cough mode, a flow rate of the fluid conducted to the patient by the respiratory device gradually increases throughout the insufflation phase (In the situation of Fig. 6D.4 and paragraph [0064], the rise time and inspiratory time has been increased so that the rise time for the flow (and pressure) is equal to about 1.6 seconds (which is the length of the insufflation phase) before the flow is reversed and the exsufflation phase begins. The effect is a slower gradual increase in flow over the course of the insufflation phase as compared to the initial setting in Fig. 6D.2 where the flow rises fairly quickly and falls slightly before the exsufflation phase begins).
As to claim 4, Truschel discloses the system as recited in claim 1, wherein the controller is configured to issue one or more commands to the respiratory device such that, during the insufflation phase of the mechanical cough mode, the pressure of the fluid conducted to the patient by the respiratory device substantially follows a line having a constant positive slope (see Fig. 5, Fig. 6D.5, paragraph [0064]: the pressure support is adjusted according to the algorithm in Fig. 5, along with the fall time, rise time, and inspiratory time to achieve the desired Target Flow Bias ratio of 1.1; the result is that the pressure follows a substantially constant slope, as shown in Fig. 6D.5).
As to claim 6, Truschel discloses the system as recited in claim 1, wherein the controller is configured to issue one or more commands to the respiratory device such that, during the insufflation phase of the mechanical cough mode, the flow rate of the fluid conducted to the patient by the respiratory device substantially follows a line having a constant positive slope (the line for the flow in Fig. 6D.4 is shown to substantially follow a line having a constant slope, as compared to the line for the flow in Fig. 6D.2, due to the longer rise time and inspiratory time).
As to claim 8, Truschel discloses the system as recited in claim 1, further comprising:
a connection (tube 12, Fig. 1); and
a patient interface (mask 14, Fig. 1) connected to the connection 12, wherein the respiratory device 10 is configured to conduct flow to the patient 16 through the patient interface 14 via the connection 12 (paragraph [0046]).
As to claim 9, Truschel discloses the system as recited in claim 8, further comprising:
a pressure sensor 34 (Fig. 3, paragraph [0055]: one or more sensors associated with the ventilator; flow and pressure are common measurements most ventilators are configured to measure); and
a flow rate sensor 34 (Fig. 3, paragraph [0018]: one or more sensors configured to detect flow rate associated with the ventilator), wherein the controller is configured to interpret signals from the pressure sensor as a pressure of the fluid conducted to the patient by the respiratory device and to interpret signals from the flow rate sensor as a flow rate of the fluid conducted to the patient by the respiratory device (Fig. 3, paragraph [0018]: one or more sensors configured to detect flow rate associated with the ventilator; paragraph [0055]: flow and pressure are common measurements most ventilators are configured to measure).
As to claim 10, Truschel discloses the system as recited in claim 1, wherein the respiratory device is operable in a ventilation mode (Figs. 3-5, paragraph [0052]: utilizes existing ventilators where parameters such as rise time, fall time, and inspiratory time are changed to operate in a mucus clearing mode, can operate in normal prescribed pressure ranges of 5-25 cmH2O for consistent ventilator use).
As to claim 11, Truschel discloses the system as recited in claim 1, wherein: the respiratory device is a ventilator 10 (Fig. 1, paragraph [0046]: basic ventilator system 10; paragraph [0010]: utilizes current mechanical ventilator equipment), and the controller 30 (Fig. 3) is configured to issue one or more commands to the ventilator 10 such that the mechanical cough mode is activated periodically (paragraph [0052]: by changing Rise Time, Fall Time, and Inspiratory Time, existing ventilators can be used for clearing mucus; paragraph [0053]: ventilator system used as a mucus clearing system 100; see Fig. 5: Parameter Controller for Mucus Clearing Mode).
As to claim 12, Truschel discloses the system as recited in claim 1, wherein the respiratory device 10 is a ventilator 10 or a mechanical insufflation-exsufflation device (basic ventilator system 10, Fig. 1, paragraph [0046]).
As to claim 13, Truschel discloses a method, comprising:
conducting fluid to a patient using a respiratory device 10 (ventilator system 10, Fig. 1, paragraph [0053]) operating in a mechanical cough mode (mucus clearing system 100, Fig. 3; parameter controller for mucus clearance mode, Fig. 5, paragraph [0059]) such that, during an insufflation phase of the mechanical cough mode 100, (i) a flow rate of the fluid conducted to the patient by the respiratory device is substantially constant throughout the insufflation phase, or (ii) a flow rate of the fluid conducted to the patient by the respiratory device gradually increases throughout the insufflation phase (Truschel discloses scenario (ii) in Fig. 6D. 4 and paragraph [0064], the rise time and inspiratory time has been increased so that the rise time for the flow (and pressure) is equal to about 1.6 seconds (which is the length of the insufflation phase) before the flow is reversed and the exsufflation phase begins. The effect is a slower gradual increase in flow over the course of the insufflation phase as compared to the initial setting in Fig. 6D.2 where the flow rises fairly quickly and falls slightly before the exsufflation phase begins).
As to claim 14, Truschel discloses the method as recited in claim 13, wherein the pressure of the fluid conducted to the patient by the respiratory device substantially follows a line having a constant positive slope (see Fig. 5, Fig. 6D.5, paragraph [0064]: the pressure support is adjusted according to the algorithm in Fig. 5, along with the fall time, rise time, and inspiratory time to achieve the desired Target Flow Bias ratio of 1.1; the result is that the pressure follows a substantially constant slope, as shown in Fig. 6D.5).
As to claim 16, Truschel discloses the method as recited in claim 13, wherein the flow rate of the fluid conducted to the patient 16 by the respiratory device 10 substantially follows a line having a constant positive slope (the line for the flow in Fig. 6D.4 is shown to substantially follow a line having a constant slope, as compared to the line for the flow in Fig. 6D.2, due to the longer rise time and inspiratory time).
As to claim 18, Truschel discloses the method as recited in claim 13, wherein the respiratory device 10 is configured to conduct fluid to the patient 16 through a patient interface 14 via a connection 12 (see Fig. 3, paragraph [0046]).
As to claim 19, Truschel discloses the method as recited in claim 18, wherein a controller issues one or more commands to the respiratory device 10 in response to signals from a pressure sensor or a flow rate sensor 34 (Figs. 3-5, paragraphs [0055]-[0057],[0059]).
As to claim 20, Truschel discloses the method as recited in claim 13, wherein the respiratory device 10 is operable in a ventilation mode (Figs. 3-5, paragraph [0052]: utilizes existing ventilators where parameters such as rise time, fall time, and inspiratory time are changed to operate in a mucus clearing mode, can operate in normal prescribed pressure ranges of 5-25 cmH2O for consistent ventilator use).
Claims 1, 2, and 12 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Goebel (US 2019/0151581).
As to claim 1, Goebel discloses a system (Fig. 1), comprising:
a respiratory device 1 configured to deliver fluid to a patient (Fig. 1, paragraph [0105]),
wherein the respiratory device 1 is operable in a mechanical cough mode (coughing device 10, used for targeted assistance of secretion removal from the airways of a patient, paragraph [0105])); and
a controller 11 (Fig. 1) configured to issue one or more commands to the respiratory device 1 (control unit 11, Fig. 1, paragraph [0106]) such that, during an insufflation phase of the mechanical cough mode, (i) a flow rate of the fluid conducted to the patient by the respiratory device 1 is substantially constant throughout the insufflation phase or (ii) a flow rate of the fluid conducted to the patient by the respiratory device 1 gradually increases throughout the insufflation phase (Goebel discloses scenario (i). Fig. 11 shows the flow during insufflation 304 in the middle graph - while there is a beginning ramp up period, once the desired flow is reached, it is held constant through the end of insufflation; this constant flow period represents the majority of the insufflation period and thus, reads on the flow rate being “substantially constant throughout the insufflation phase”; see also paragraph [0016]: Because of the at least two fans, it is possible to change substantially more quickly between insufflation and exsufflation, since it is not first necessary to wait for a speed adaptation or the like. Using the valve unit, it is then possible to switch rapidly from one fan to the other, while, for example, a speed of the fans was already set appropriately beforehand).
As to claim 2, Goebel discloses the system as recited in claim 1, wherein, during the insufflation phase of the mechanical cough mode, a flow rate of the fluid conducted to the patient by the respiratory device is substantially constant throughout the insufflation phase (Fig. 11 shows the flow during insufflation 304 in the middle graph - while there is a beginning ramp up period, once the desired flow is reached, it is held constant through the end of insufflation; this constant flow period represents the majority of the insufflation period and thus, reads on the flow rate being “substantially constant throughout the insufflation phase”; see also paragraph [0016]: Because of the at least two fans, it is possible to change substantially more quickly between insufflation and exsufflation, since it is not first necessary to wait for a speed adaptation or the like. Using the valve unit, it is then possible to switch rapidly from one fan to the other, while, for example, a speed of the fans was already set appropriately beforehand).
As to claim 13, Goebel discloses a method, comprising:
conducting fluid to a patient using a respiratory device 1 (Fig. 1, paragraph [0105]) operating in a mechanical cough mode (coughing device 10, used for targeted assistance of secretion removal from the airways of a patient, paragraph [0105]) such that, during an insufflation phase of the mechanical cough mode, (i) a flow rate of the fluid conducted to the patient by the respiratory device is substantially constant throughout the insufflation phase, or (ii) a flow rate of the fluid conducted to the patient by the respiratory device gradually increases throughout the insufflation phase (Goebel discloses scenario (i). Fig. 11 shows the flow during insufflation 304 in the middle graph - while there is a beginning ramp up period, once the desired flow is reached, it is held constant through the end of insufflation; this constant flow period represents the majority of the insufflation period and thus, reads on the flow rate being “substantially constant throughout the insufflation phase”; see also paragraph [0016]: Because of the at least two fans, it is possible to change substantially more quickly between insufflation and exsufflation, since it is not first necessary to wait for a speed adaptation or the like. Using the valve unit, it is then possible to switch rapidly from one fan to the other, while, for example, a speed of the fans was already set appropriately beforehand).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 5, 7, 15, and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Truschel et al. (US 2024/0091473), in view of Goebel (US 2019/0151581).
As to claim 5, Truschel discloses the system as recited in claim 4, but does not disclose that the controller is configured to issue one or more commands to the respiratory device such that, during the insufflation phase of the mechanical cough mode, the pressure of the fluid conducted to the patient by the respiratory device oscillates relative to the line. However, Goebel teaches a coughing device and method which includes an oscillator unit to oscillate the pressure and/or flow during an insufflation phase (paragraph [0051]). Therefore, it would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to modify the system of Truschel so that the pressure oscillates relative to the slope of the line, as taught by Goebel, to further encourage the breaking up of fluid in the airways of the patient for better secretion removal (see Goebbel, paragraph [0051]).
As to claim 7, Truschel discloses the system as recited in claim 6, but does not disclose that the controller is configured to issue one or more commands to the respiratory device such that, during the insufflation phase of the mechanical cough mode, the flow rate of the fluid conducted to the patient by the respiratory device oscillates relative to the line. However, Goebel teaches a coughing device and method which includes an oscillator unit to oscillate the pressure and/or flow during an insufflation phase (paragraph [0051]). Therefore, it would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to modify the system of Truschel so that the flow oscillates relative to the slope of the line, as taught by Goebel, to further encourage the breaking up of fluid in the airways of the patient for better secretion removal (see Goebbel, paragraph [0051]).
As to claim 15, Truschel discloses the method as recited in claim 14, but does not disclose that the pressure of the fluid conducted to the patient by the respiratory device oscillates relative to the line. However, Goebel teaches a coughing device and method which includes an oscillator unit to oscillate the pressure and/or flow during an insufflation phase (paragraph [0051]). Therefore, it would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to modify the method of Truschel so that the pressure oscillates relative to the slope of the line, as taught by Goebel, to further encourage the breaking up of fluid in the airways of the patient for better secretion removal (see Goebbel, paragraph [0051]).
As to claim 17, Truschel discloses the method as recited in claim 16, but does not disclose that the flow rate of the fluid conducted to the patient by the respiratory device oscillates relative to the line. However, Goebel teaches a coughing device and method which includes an oscillator unit to oscillate the pressure and/or flow during an insufflation phase (paragraph [0051]). Therefore, it would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to modify the method of Truschel so that the flow oscillates relative to the slope of the line, as taught by Goebel, to further encourage the breaking up of fluid in the airways of the patient for better secretion removal (see Goebbel, paragraph [0051]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Oldfield et al. (US 2021/0052844) discloses a ventilator wherein the flow rate is oscillated.
Bobey (US 20170027813) discloses a cough assist device that utilizes an oscillator to superimpose oscillations onto the insufflation pressure.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to VALERIE L WOODWARD whose telephone number is (571)270-1479. The examiner can normally be reached on Monday - Friday 8:30 am - 4:30 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, KENDRA CARTER can be reached on 571-272-9034. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/VALERIE L WOODWARD/Primary Examiner, Art Unit 3785
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