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 .
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 and 10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Allum et al (US 2010/0071693), hereinafter Allum.
Regarding claim 1, Allum teaches a ventilator system configured to switch between one or more invasive ventilation modes and one or more non-invasive ventilation modes (Paragraph 92, may operate during spontaneous breathing or non-invasively or during controlled ventilation, invasive ventilation see paragraph 60 typically provided with an endotracheal tube), the ventilator system comprising:
an externally pressurized source of pre-mixed gas including air and oxygen; (Paragraph 95, may have a compressed oxygen supply and compressed air fed to a blender 187, external to the ventilator, paragraph 96, the blender may external or internal to the ventilator)
one or more inspiratory valves configured to delivery incoming pre-mixed gas to a patient’s breathing circuit (Paragraph 92, inspiratory valve 103) ; and
one or more expiratory valves configured to remove outgoing gas from the patient’s breathing circuit (paragraph 92, exhalation valve 109);
wherein in the one or more invasive ventilation modes, the inspiratory valves and the expiratory valves are configured to open and close to allow or prevent the passage of gas as needed in order to enforce a respiration cycle within the patient (the valves may be switched to an active valve which is cycled open by the ventilator controls, paragraph 92); and
wherein in the one or more non-invasive modes, the inspiratory valves and the expiratory valves are kept open in order to allow the gas to pass freely through the system (Paragraph 92, the valve is typically a passive valve opened with light pressure).
Regarding claim 10, Allum teaches a method (Paragraph 92, may operate during spontaneous breathing or non-invasively or during controlled ventilation, invasive ventilation see paragraph 60 typically provided with an endotracheal tube)comprising:
delivering, by a ventilator, incoming pre-mixed gas including air and oxygen to a patient’s breathing circuit (Paragraph 95, may have a compressed oxygen supply and compressed air fed to a blender 187, external to the ventilator, paragraph 96, the blender may external or internal to the ventilator)
via one or more inspiratory valves of the ventilator; (paragraph 92, inspiratory valve 103)
removing, by the ventilator, outgoing gas from the patient’s breathing circuit via one or more expiratory valves of the ventilator; (Paragraph 92, exhalation valve) and
switching, by the ventilator, between one or more invasive ventilations modes and one or more non-invasive ventilation modes; (paragraph 92, may be changed from an open ventilation to a closed ventilation)
in the one or more invasive ventilation modes, opening and closing, by the ventilator, the inspiratory valves and the expiratory valves to allow or prevent the passage of gas as needed in order to enforce a respiration cycle with the patient; (the valves may be switched to an active valve which is cycled open by the ventilator controls, paragraph 92); and
in the one or more non-invasive ventilation modes, opening, by the ventilator, the inspiratory valves and the expiratory valves in order to allow the gas to pass freely through the system. (Paragraph 92, the valve is typically a passive valve opened with light pressure).
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 nonobviousness.
Claims 2 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Allum in view of Atkins (US Pat. No. 5,239,994), hereinafter Atkins.
Regarding claim 2, Allum teaches the ventilator system of claim 1, but does not explicitly state wherein the respiration cycle is based on a pressure-limited-time-cycled breathing loop.
However, Atkins teaches a ventilation device (Abstract, Fig. 1, Fig. 2) wherein the respiration cycle is based on a pressure-limited time cycled breathing loop. (Col. 1: lines 22-25)
It would have been obvious to a person of ordinary skill in the art at the time the invention was filed to have provided a respiration cycle based on a pressure-limited-time-cycled breathing loop as taught by Atkins because such cycles are typically provided to neonatal patients to provide a generally constant flow of gas through the breathing circuit.
Regarding claim 11, Allum teaches the method of claim 10, but does not explicitly state wherein the respiration cycle is based on a pressure-limited-time-cycled breathing loop.
However, Atkins teaches a ventilation device (Abstract, Fig. 1, Fig. 2) wherein the respiration cycle is based on a pressure-limited time cycled breathing loop. (Col. 1: lines 22-25)
It would have been obvious to a person of ordinary skill in the art at the time the invention was filed to have provided a respiration cycle based on a pressure-limited-time-cycled breathing loop as taught by Atkins because such cycles are typically provided to neonatal patients to provide a generally constant flow of gas through the breathing circuit.
Claims 3, 4, 12, and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Allum in view of Decker (US 2017/0241581), hereinafter Decker.
Regarding claim 3, Allum teaches the ventilator system of claim 1, but is silent as to comprising a manual control valve.
However, Decker teaches an oxygen supply quick adapter (Abstract) further comprising a manual control valve, wherein a flow rate is set by a user via the manual control valve. (Paragraph 5, attached at the outlet a Thorpe Tube which regulates the flow through the use of a knob that is turned counter clockwise or clockwise to achieve the desired flow rate)
It would have been obvious to a person of ordinary skill in the art to have included a manual control valve in the device of Allum as this is a standard way of adjusting a flow rate from a hospital oxygen or air flow outlet. (paragraph 5)
Regarding claim 4, Allum in view of Decker teaches the ventilator system of claim 1, and Decker further teaches wherein the manual control valve is a Thorpe Tube. (Paragraph 5)
Regarding claim 12, Allum teaches the method of claim 10, but is silent as to comprising a manual control valve.
However, Decker teaches an oxygen supply quick adapter (Abstract) further comprising a manual control valve, wherein a flow rate is set by a user via the manual control valve. (Paragraph 5, attached at the outlet a Thorpe Tube which regulates the flow through the use of a knob that is turned counter clockwise or clockwise to achieve the desired flow rate)
It would have been obvious to a person of ordinary skill in the art to have included a manual control valve in the device of Allum as this is a standard way of adjusting a flow rate from a hospital oxygen or air flow outlet. (paragraph 5)
Regarding claim 13, Allum teaches the method of claim 10, and Decker further teaches wherein the manual control valve is a Thorpe Tube. (Paragraph 5)
Claims 5 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Allum in view of Kroupa (US 2008/03202363), hereinafter Kroupa.
Regarding claim 5, Allum teaches the ventilator system of claim 1, but is silent as to wherein an inspiratory time is set by a user such that a known volume of gas is delivered during each inspiration phase.
However, Kroupa teaches a ventilator apparatus (Abstract, Fig. 1) wherein an inspiratory time is set by a user such that a known volume of gas is delivered during each inspiration phase. (Paragraph 42, 44), the user selects the time in combination with other factors to determine the desired volume)
It would have been obvious to a person of ordinary skill in the art to have included wherein an inspiratory time is set by a user such that known volume of gas is delivered during each inspiration phase as taught by Kroupa in order to deliver the desired tidal volume to a user.
Regarding claim 14, Allum teaches the method of claim 10, but is silent as to wherein an inspiratory time is set by a user such that a known volume of gas is delivered during each inspiration phase.
However, Kroupa teaches a ventilator apparatus (Abstract, Fig. 1) wherein an inspiratory time is set by a user such that a known volume of gas is delivered during each inspiration phase. (Paragraph 42, 44), the user selects the time in combination with other factors to determine the desired volume)
It would have been obvious to a person of ordinary skill in the art to have included wherein an inspiratory time is set by a user such that known volume of gas is delivered during each inspiration phase as taught by Kroupa in order to deliver the desired tidal volume to a user.
Claims 6, 7, 15, and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Allum in view of Bernard (US Pat. No. 4,870,961), hereinafter Bernard.
Regarding claim 6, Allum teaches the ventilator system of claim 1, but does not teach further comprising one or more sensors positioned on the expiration side of the patients’ breathing circuit and configured to measure exhaled volume of gas.
However, Bernard teaches a ventilator (abstract, Fig. 1) comprising one or more sensors positioned on the expiration side of the patients’ breathing circuit and configured to measure exhaled volume of gas. (col. 4: lines 29-39, spirometer 17)
It would have been obvious to a person of ordinary skill in the art prior to the filing date of the invention to have provided Allum with a sensor positioned on the expiration side of the patient’s breathing circuit to detect a system malfunction or circuit leak. (Col. 4: lines 29-39)
Regarding claim 7, Allum in view of Bernard teaches the ventilator system of claim 6, and Bernard further teaches wherein the one or more sensors include one or more of a flowmeter or spirometer. (Col. 4: lines 29-39, spirometer)
Regarding claim 15, Allum teaches the method of claim 10 but does not teach further comprising one or more sensors positioned on the expiration side of the patients’ breathing circuit and configured to measure exhaled volume of gas.
However, Bernard teaches a ventilator (abstract, Fig. 1) comprising one or more sensors positioned on the expiration side of the patients’ breathing circuit and configured to measure exhaled volume of gas. (col. 4: lines 29-39, spirometer 17)
It would have been obvious to a person of ordinary skill in the art prior to the filing date of the invention to have provided Allum with a sensor positioned on the expiration side of the patient’s breathing circuit to detect a system malfunction or circuit leak. (Col. 4: lines 29-39)
Regarding claim 16, Allum teaches the method of claim 16, and Bernard further teaches wherein the one or more sensors include one or more of a flowmeter or spirometer. (Col. 4: lines 29-39, spirometer)
Claims 8 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Allum in view of Isaza (US 2008/0060656), hereinafter Isaza.
Regarding claim 8, Allum teaches the ventilator system of claim 1, but does not teach further comprising a monitoring device configured to monitor pressures in the inspiratory valves and the expiratory valves to identify instances of leaks or blockages.
However, Isaza teaches a ventilator system (Fig. 1) comprising a monitoring device configured to monitor pressures in the inspiratory valves and the expiratory valves (Paragraph 41, Fig. 1B, an inhalation monitor, an exhalation monitor which use pressure transducers capable of sensing pressure conditions in the communicating passage) to identify instances of leaks or blockages. (paragraph 11, the controller is further adapted to determine whether a circuit disconnect or an occlusion exists based on the monitored pressure.)
It would have been obvious to a person of ordinary skill in the art prior to the filing date of the invention to have included monitoring the pressure in the inspiratory and expiratory valves in the system of Allum as taught by Isaza in order to monitor for anomalies to maximize safety of the ventilator. (paragraph 11)
Regarding claim 17, Allum teaches the method of claim 10, , but does not teach further comprising a monitoring device configured to monitor pressures in the inspiratory valves and the expiratory valves to identify instances of leaks or blockages.
However, Isaza teaches a ventilator system (Fig. 1) comprising a monitoring device configured to monitor pressures in the inspiratory valves and the expiratory valves (Paragraph 41, Fig. 1B, an inhalation monitor, an exhalation monitor which use pressure transducers capable of sensing pressure conditions in the communicating passage) to identify instances of leaks or blockages. (paragraph 11, the controller is further adapted to determine whether a circuit disconnect or an occlusion exists based on the monitored pressure.)
It would have been obvious to a person of ordinary skill in the art prior to the filing date of the invention to have included monitoring the pressure in the inspiratory and expiratory valves in the system of Allum as taught by Isaza in order to monitor for anomalies to maximize safety of the ventilator. (paragraph 11)
Claims 9 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Allum in view of Woodring et al (US 2003/0062045), hereinafter Woodring.
Regarding claim 9, Allum teaches the ventilator system of claim 1, but is silent as to wherein switching between the one or more invasive ventilation modes and the one or more non-invasive ventilation modes is controlled based on input from a user.
However, Woodring teaches a mechanical ventilator (Abstract, Figs. 1-2) wherein switching between the one or more invasive ventilation modes and the one or more non-invasive ventilation modes is controlled based on input from a user. (paragraph 87)
It would have been obvious to a person of ordinary skill in the art prior to the filing date of the invention to have provided Allum with the ability to switch between one or more invasive ventilation modes and one or more non-invasive modes controlled on input from a user in order to allow the operator to select the desired mode. (paragraph 87)
Regarding claim 18, Allum teaches the method of claim 10, but is silent as to wherein switching between the one or more invasive ventilation modes and the one or more non-invasive ventilation modes is controlled based on input from a user.
However, Woodring teaches a mechanical ventilator (Abstract, Figs. 1-2) wherein switching between the one or more invasive ventilation modes and the one or more non-invasive ventilation modes is controlled based on input from a user. (paragraph 87)
It would have been obvious to a person of ordinary skill in the art prior to the filing date of the invention to have provided Allum with the ability to switch between one or more invasive ventilation modes and one or more non-invasive modes controlled on input from a user in order to allow the operator to select the desired mode. (paragraph 87)
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARGARET M LUARCA whose telephone number is (303)297-4312. The examiner can normally be reached 6:30 am - 3:30 pm MT.
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, Brandy Lee can be reached at 571-270-7410. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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.
/MARGARET M LUARCA/Primary Examiner, Art Unit 3785