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 Objections
Claims 2-12, 21-23 objected to because of the following informalities:
Claims 7-9 each recite “The system of any of claim 1” should be -The high flow therapy system of claim 1-
Claims 2-6, 10-12, 21-23 each recite “The system of” in line 1 should be -The high flow therapy system of-
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.
(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 1-10 and 13-26 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Oldfield (US 20180071469 A1).
Regarding claim 1, Oldfield discloses a high flow therapy system (see [0001]) (Fig. 1-14), comprising:
an oxygen source ([0098]) configured to provide oxygen to an oxygen delivery lumen (Fig. 1A and [0252] there is an oxygen delivery gas line 12) at a first flow rate of between 15 lpm and 60 lpm ([0282] oxygen flow rate may be provided to a user via the oxygen gas line during inspiration phase, wherein [0345] provides the flow rate of gases may be 40-80 lpm as a useful flow rate range);
an air source ([0101] second gas provided is an air source) configured to provide air to an air delivery lumen (Fig. 1A and [0252] there is an air delivery gas line 12) at a second flow rate of between 15 lpm and 60 lpm (see [0281] air is delivered to a user via the air delivery lumen during exhalation phase at a flow rate of 30-70 lpm); and
a controller ([0096]) (Fig. 1A-1C) configured to (i) direct the oxygen source to provide the oxygen to the oxygen delivery lumen at the first flow rate during an inhalation phase of a breath ([0281] controller controls the oxygen to be provided via gas line being the oxygen delivery lumen at its first flow rate during inhale) (Fig. 1A-1C), and
(ii) direct the air source to provide the air to the air delivery lumen at the second flow rate during an exhalation phase of the breath ([0281] controller controls the oxygen to stop being provided with just an air flow being administered during exhale at the second flow rate) (Fig. 1A-1C).
Regarding claim 2, Oldfield discloses the invention of claim 1.
Oldfield further discloses wherein the controller is further configured to (iii) direct the oxygen source to cease delivery of the oxygen during the exhalation phase of the breath ([0281] the valve of oxygen delivery is closed, and oxygen is stored and preserved during the exhalation phase of breath, see [0132, 0242]), and (iv) direct the air source to cease delivery of the air during the inhalation phase of the breath ([0241], during inhalation/inspiration normal air delivery is ceased to allow gases such as oxygen from reservoirs to be delivered instead).
Regarding claim 3, Oldfield discloses the invention of claim 1.
Oldfield further discloses wherein the controller is configured to direct the oxygen source to provide the oxygen to the oxygen delivery lumen during a first period of the inhalation phase ([0095-0101, 0365-0366] controller controls pure oxygen to be delivered, thus inhaled, to the user during a first period of time), and wherein the controller is further configured to direct the air source to provide the air to the air delivery lumen during a second period of the inhalation phase ([0095-0101, 0365-0366] during a second period of delivery, being inhalation, to a patient, a lower mixed amount of oxygen and helium/nitrogen being air may be delivered).
Regarding claim 4, Oldfield discloses the invention of claim 1.
Oldfield further discloses wherein the first flow rate is between 30 lpm and 60 lpm, and wherein the second flow rate is between 30 lpm and 60 lpm ([0287] the flow rate of provided gases may be at the substantially same level at all phases, thus as provided in [0281] the second flow rate during expiration/exhale of 30-70 lpm may also be the first flow rate during inspiration/inhale).
Regarding claim 5, Oldfield discloses the invention of claim 1.
Oldfield further discloses wherein the first flow rate and the second flow rate are about the same ([0287] the flow rate of provided gases may be at the substantially same level at all phases, thus as provided in [0281] the second flow rate during expiration/exhale of 30-70 lpm may also be the first flow rate during inspiration/inhale).
Regarding claim 6, Oldfield discloses the invention of claim 1.
Oldfield further discloses a pressure sensor, wherein the controller is configured to identify the inhalation phase and/or the exhalation phase based at least in part on one or more inputs from the pressure sensor ([0248-0249] pressure sensors used to determine by controller the inhalation and exhalation phase).
Regarding claim 7, Oldfield discloses the invention of claim 1.
Oldfield further discloses a first flow sensor configured to measure a flow of the oxygen from the oxygen source and a second flow sensor configured to measure a flow of air from the air source ([0292-0293, 302] there are flow sensors able to measure and the flow of any of the gases present, thus there being a first flow sensor corresponding to oxygen flow rate and a second flow sensor for flow of air).
Regarding claim 8, Oldfield discloses the invention of claim 1.
Oldfield further discloses a housing, wherein the oxygen source and the air source are positioned within the housing ([0241, 0270] the flow generator 50 may contain both the air supply and gas supply, thus being a housing containing each source of oxygen/air therein).
Regarding claim 9, Oldfield discloses the invention of claim 1.
Oldfield further discloses a patient circuit (breathing circuit 15, [0247], Fig. 1A-1B) including the oxygen delivery lumen and the air delivery lumen, wherein the oxygen delivery lumen and the air delivery lumen are fluidly isolated (Fig. 1A and [0247], there is the gas line 12 going from the flow source 10/flow meter 11 to the reservoir 14 containing oxygen having then another gas line 17 going through the circuit 15 to then reach the patient being the oxygen delivery lumen, and a second gas line 12 that instead extends directly from the flow meter 11 to the circuit 15, see [0250] wherein these may be independent fluidly isolated lumen configurations, see further [0252).
Regarding claim 10, Oldfield discloses the invention of claim 9.
Oldfield further discloses wherein the oxygen delivery lumen is coupled to the air delivery lumen (Fig. 1A-1B, each of the oxygen and air delivery lumen are shown to be coupled to each other via the coupling to the flow meter 11 and ultimate coupling to the breathing circuit 15).
Regarding claim 13, Oldfield discloses a method for delivering high flow therapy to a patient (see [0001]) (Fig. 1A-1B, method in Fig. 1C, also Fig. 5A-5C), the method comprising:
detecting a beginning of an inhalation phase of a breath of the patient ([0233, 0248, 0281] the inspiration/inhalation phase of breath is detected and determined);
delivering oxygen to the patient during the inhalation phase ([0281] controller controls the oxygen to be provided via gas line being the oxygen delivery lumen at its first flow rate during inhale, see also [0233, 0243]) (Fig. 1A-1C and 5A-5C) at a first flow rate of between 15 lpm and 60 lpm ([0282] oxygen flow rate may be provided to a user via the oxygen gas line during inspiration phase, wherein [0345] provides the flow rate of gases may be 40-80 lpm as a useful flow rate range);
detecting a beginning of an exhalation phase of the breath of the patient ([0281] the exhalation phase of breathing is detected and determined by the system); and
delivering air to the patient during the exhalation phase ([0281] controller controls the oxygen to stopped being provided with just an air flow being administered during exhale at the second flow rate) (Fig. 1A-1C, 5A-5C) at a second flow rate of between 15 lpm and 60 lpm (see [0281] air is delivered to a user via the air delivery lumen during exhalation phase at a flow rate of 30-70 lpm).
Regarding claim 14, Oldfield discloses the invention of claim 13.
Oldfield further discloses ceasing delivery of the oxygen during the exhalation phase of the breath ([0281] the valve of oxygen delivery is closed, and oxygen is stored and preserved during the exhalation phase of breath, see [0132, 0242]), and ceasing delivery of the air during the inhalation phase of the breath ([0241], during inhalation/inspiration normal air delivery is ceased to allow gases such as oxygen from reservoirs to be delivered instead).
Regarding claim 15, Oldfield discloses the invention of claim 13.
Oldfield further discloses wherein the first flow rate is between 30 lpm and 60 lpm, and wherein the second flow rate is between 30 lpm and 60 lpm ([0287] the flow rate of provided gases may be at the substantially same level at all phases, thus as provided in [0281] the second flow rate during expiration/exhale of 30-70 lpm may also be the first flow rate during inspiration/inhale).
Regarding claim 16, Oldfield discloses the invention of claim 13.
Oldfield further discloses wherein the first flow rate and the second flow rate are about the same ([0287] the flow rate of provided gases may be at the substantially same level at all phases, thus as provided in [0281] the second flow rate during expiration/exhale of 30-70 lpm may also be the first flow rate during inspiration/inhale).
Regarding claim 17, Oldfield discloses the invention of claim 13.
Oldfield further discloses wherein the oxygen is delivered through a first lumen and the air is delivered through a second lumen, wherein the first lumen is fluidly isolated from the second lumen along a substantial portion of the first lumen and the second lumen (Fig. 1A and [0247], there is the gas line 12 going from the flow source 10/flow meter 11 to the reservoir 14 containing oxygen having then another gas line 17 going through the circuit 15 to then reach the patient being the oxygen delivery first lumen, and a second gas line 12 that instead extends directly from the flow meter 11 to the circuit 15 being the air second lumen, see [0250] wherein these may be independent fluidly isolated lumen configurations thus fluidly isolated along a substantial portion of the first/second lumens, see further [0252).
Regarding claim 18, Oldfield discloses the invention of claim 13.
Oldfield further discloses humidifying the oxygen before delivering the oxygen to the patient during the inhalation phase ([0270] and Fig. 5A-5B, shows the oxygen gas held in the reservoir 14 will be passed through the humidifier 51 to be humidified before then being delivered to the patient, [0030, 0243] oxygen is delivered during inhale/inspiration).
Regarding claim 19, Oldfield discloses the invention of claim 13.
Oldfield further discloses humidifying the air before delivering the air to the patient during the exhalation phase ([0270] and Fig. 5A-5B, shows the air gas from the flow source will be passed through the humidifier 51 to be humidified before then being delivered to the patient, [0281, 0243] air is delivered during exhale/expiration).
Regarding claim 20, Oldfield discloses the invention of claim 13.
Oldfield further discloses delivering the oxygen to the patient during the inhalation phase delivers an oxygenated breath to the user ([0270, 0281, 243] concentrated oxygen is delivered to patient during inspiration/inhale, thus delivering an oxygenated breath to the user), and
wherein delivering the air to the to the patient during the exhalation phase clears carbon dioxide from the patient's airways ([0281, 0243] air/less oxygenated gas is delivered during exhale/expiration, [0272] CO2 is flushed from the user with this system).
Regarding claim 21, Oldfield discloses the invention of claim 1.
Oldfield further discloses wherein the oxygen is greater than 21% O2 ([0328] during inspiration the oxygen supplementary gas may be 80% oxygen).
Regarding claim 22, Oldfield discloses the invention of claim 1.
Oldfield further discloses wherein the oxygen is between about 80% and 100% O2 ([0328] during inspiration the oxygen supplementary gas may be 80% oxygen).
Regarding claim 23, Oldfield discloses the invention of claim 1.
Oldfield further discloses wherein the controller is further configured to (iii) direct the air source to provide the air to the air delivery lumen during the inhalation phase of the breath in combination with directing the oxygen source to provide the oxygen to the oxygen delivery lumen (Fig. 1B, 5B, [0241] during inspiration/inhalation phase both oxygen as well as other gases being the air may be supplied to the patient simultaneously through their lumens).
Regarding claim 24, Oldfield discloses the invention of claim 13.
Oldfield further discloses wherein the oxygen is greater than 21% O2 ([0328] during inspiration the oxygen supplementary gas may be 80% oxygen).
Regarding claim 25, Oldfield discloses the invention of claim 13.
Oldfield further discloses wherein the oxygen is between about 80% and 100% O2 ([0328] during inspiration the oxygen supplementary gas may be 80% oxygen).
Regarding claim 26, Oldfield discloses the invention of claim 13.
Oldfield further discloses delivering the air during the inhalation phase in combination with delivering the oxygen during the inhalation phase (Fig. 1B, 5B, [0241] during inspiration/inhalation phase both oxygen as well as other gases being the air may be supplied to the patient simultaneously through their lumens).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 11-12 are rejected under 35 U.S.C. 103 as being unpatentable over Oldfield (US 20180071469 A1) in view of Canady (US 20210316153 A1).
Regarding claim 11, Oldfield discloses the invention of claim 1.
Oldfield further discloses a first humidifier 51 configured to heat and/or humidify the oxygen and air (Fig. 5A-5B, [0270] there is a central humidifier 51 that humidifies and heats both the oxygen and air).
Oldfield does not disclose the first humidifier being configured to heat and/or humidify the oxygen, and a second humidifier configured to heat and/or humidify the air.
However, Canady teaches an analogous gas system (Fig. 1-11) comprising an supply carrier gas being an analogous oxygen source (Fig. 6 and [0015]) being separate from a supply feed gas being an analogous air source (Fig. 6 and [0015]), wherein there is a first humidifier being configured to heat and/or humidify the oxygen (Fig. 6 and [0015-0017], first humidifier for the carrier gas), and a second humidifier configured to heat and/or humidify the air (Fig. 6 and [0015-0017], second humidifier for the feed gas).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the humidifier 51 of Oldfield to be a separate first and second humidifier such that there is a first humidifier being configured to heat and/or humidify the oxygen, and a second humidifier configured to heat and/or humidify the air as taught by Canady in order to be able better control the humidity of each gas (Canady [0017] separate humidifiers enables different humidity levels to be controlled).
Regarding claim 12, Oldfield discloses the invention of claim 11.
Oldfield as combined with Canady teaches a humidifier assembly, the humidifier assembly including the first humidifier and the second humidifier, and wherein the humidifier assembly is configured to isolate the oxygen and the air (Canady Fig. 6 and [0017] there is a humidifier assembly being the first and second humidifiers, wherein they as described each separately interact with the feed gas and carrier gas sources, thus as combined with Oldfield, the oxygen and air are isolated within the assembly).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KEVIN S ALBERS whose telephone number is (571)272-0139. The examiner can normally be reached Monday-Friday 7:30 am to 5:00 pm.
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/KEVIN S ALBERS/Patent Examiner, Art Unit 3786
/KERI J NELSON/Primary Examiner, Art Unit 3786
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