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
Information Disclosure Statement
The information disclosure statement (IDS) filed June 24, 2024, fails to comply with 37 CFR 1.98(a)(2), which requires a legible copy of each cited foreign patent document; each non-patent literature (NPL) publication or that portion which caused it to be listed; and all other information or that portion which caused it to be listed. Currently, it does not include the cited NPL “Final Office Action mailed December 14, 2020 for U.S. Patent Application No. 14/016,042”. The IDS has been placed in the application file and been fully considered except for the section struck through therein.
Election/Restriction
Restriction to one of the following inventions is required under 35 U.S.C. 121:
Claims 1-12, drawn to a high flow therapy system, classified in A61M16/0066
Claims 13-20, drawn to a valve assembly, classified in A61M16/20
The inventions are independent or distinct, each from the other because: Inventions I and II are related as combination and subcombination. Inventions in this relationship are distinct if it can be shown that (1) the combination as claimed does not require the particulars of the subcombination as claimed for patentability, and (2) that the subcombination has utility by itself or in other combinations (MPEP § 806.05(c)).
In the instant case, the combination as claimed does not require the particulars of the subcombination as claimed because the combination of Claims 1-12 does not require the valve assembly of Claims 13-20 to deliver the respiratory gas at flow rates up to 60 L/min. The subcombination has separate utility as a gas delivery system without a microprocessor or high flow therapy system. The subcombination could also alternatively utilize a sealed respiratory interface.
The examiner has required restriction between combination and subcombination inventions. Where applicant elects a subcombination, and claims thereto are subsequently found allowable, any claim(s) depending from or otherwise requiring all the limitations of the allowable subcombination will be examined for patentability in accordance with 37 CFR 1.104. See MPEP § 821.04(a). Applicant is advised that if any claim presented in a divisional application is anticipated by, or includes all the limitations of, a claim that is allowable in the present application, such claim may be subject to provisional statutory and/or nonstatutory double patenting rejections over the claims of the instant application.
Restriction for examination purposes as indicated is proper because all the inventions listed in this action are independent or distinct for the reasons given above and there would be a serious search and/or examination burden if restriction were not required because one or more of the following reasons apply:
The inventions have acquired a separate status in the art in view of their different classification (and thus different classes must be searched);
The inventions have acquired a separate status in the art due to their recognized divergent subject matter;
The inventions require a different field of search (for example, searching different classes/subclasses or electronic resources, or employing different search queries);
The prior art applicable to one invention would not likely be applicable to another invention;
The inventions are likely to raise different non-prior art issues under 35 U.S.C. 101 and/ 35 U.S.C. 112(a).
Applicant is advised that the reply to this requirement to be complete must include (i) an election of an invention to be examined even though the requirement may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing the elected invention.
The election of an invention may be made with or without traverse. To reserve a right to petition, the election must be made with traverse. If the reply does not distinctly and specifically point out supposed errors in the restriction requirement, the election shall be treated as an election without traverse. Traversal must be presented at the time of election in order to be considered timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are added after the election, applicant must indicate which of these claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
During a telephone conversation with Ray Churchill on July 22, 2026, a provisional election was made without traverse to prosecute the invention of Group I, Claims 1-12. Affirmation of this election must be made by applicant in replying to this Office action. Claims 13-20 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Claim Rejections - 35 USC § 102
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 1-5, 8, and 11-12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lewis et al. (US 20080142019 A1, hereinafter "Lewis").
Regarding Claim 1, Lewis discloses: A high flow therapy system for delivering heated and humidified respiratory gas to an airway of a patient (Paragraph 0110, Now referring to FIGS. 15-17, a high flow therapy device 2000 is shown. High flow therapy device 2000 is configured for use with a non-sealing respiratory interface, such as cannula 100, for example, to deliver gas to a patient. In various embodiments, high flow therapy device 2000 is able to heat, humidify, and/or oxygenate a gas prior to delivering the gas to a patient), the high flow therapy system comprising:
a non-sealing respiratory interface (Paragraph 0111, A non-sealing respiratory interface (such as a nasal cannula illustrated in FIGS. 1-14 (e.g., 100 or 1200 and hereinafter referred to as 100), is configured to mechanically cooperate with gas outlet port 2050 to supply a patient with gas);
a delivery circuit for delivering the respiratory gas to the airway of the patient via the non- sealing respiratory interface (Paragraph 0116, a circuit 2210 disposed between respiratory interface 100 and gas outlet port 2050), (Paragraph 0143, With reference to FIGS. 25-28, a connector 4000 for use a system for delivery of respiratory gases (e.g., high flow therapy device 2000) is shown. Connector 4000 includes a gas lumen 4010 and a pressure conduit 4020. Gas lumen 4010 is configured to link a gas outlet 4110 of a therapy device 4100 (e.g., high flow therapy device 2000) with a gas inlet 4210 of a delivery conduit 4200);
a microprocessor configured to control a flow rate of the respiratory gas (Paragraph 0114, based on measurements taken by sensor 2120 and relayed to microprocessor 2060, microprocessor 2060 is able to adjust the temperature of the gas, the humidity of the gas, the amount of oxygen of the gas, flow rate of the gas and/or the volume of the gas delivered to the patient),
wherein the microprocessor is configured to control delivery of flow rates up to 60 L/min (Paragraph 0117, Blower 2080 is configured to provide a patient (e.g., an adult patient) with a gas flow rate of up to about 60 liters per minute);
a first manifold adapted to affect a flow rate (Paragraph 0140, The present disclosure also relates to a high flow therapy system 2000 including a microprocessor 2060, a heating element 2110, a humidity chamber 2020, a conduit 2130, at least one proportional valve 2132 (see FIGS. 32A and 32B) and a feedback system) of a first portion of the respiratory gas (Paragraph 0118, As shown in FIGS. 16 and 17, oxygen flowing through oxygen flow tube 2150 mixes with ambient air (or filtered air) flowing through air flow tube 2140 in a mixing area 2155 prior to entering humidity chamber 2020),
wherein the first manifold includes a gas inlet, a gas outlet (Paragraph 0111, High flow therapy device 2000 is shown in FIG. 15 including a housing 2010, a humidity chamber 2020 (e.g., vapor generator), a user interface 2030, a gas inlet port 2040 and a gas outlet port 2050. A microprocessor 2060, an air inlet port 2070, a blower 2080, an oxygen inlet 2090 and a proportional valve 2100 are illustrated in FIG. 16), a first proportional valve, and a second proportional valve (Figures 32A-32B, proportional valve 2132),
wherein the first proportional valve and the second proportional valve are coupled in parallel between the gas inlet and the gas outlet (Figures 32A-32B, Paragraph 0150, The schematic illustrates how two proportional valves 2132 may be used to control flow over a wider range than would be effective with a single proportional valve);
and a second manifold adapted to affect a flow rate of a second portion of the respiratory gas (Paragraph 0140, The present disclosure also relates to a high flow therapy system 2000 including a microprocessor 2060, a heating element 2110, a humidity chamber 2020, a conduit 2130, at least one proportional valve 2132 (see FIGS. 32A and 32B) and a feedback system),
wherein the first portion of the respiratory gas is different from the second portion of the respiratory gas (Paragraph 0118, With continued reference to FIG. 16, oxygen inlet 2090 and is configured to connect to an external source of oxygen (or other gas) (not explicitly shown) to allow oxygen to pass through high flow therapy device 2000 and mix with ambient air, for instance […] As shown in FIGS. 16 and 17, oxygen flowing through oxygen flow tube 2150 mixes with ambient air (or filtered air) flowing through air flow tube 2140 in a mixing area 2155 prior to entering humidity chamber 2020).
Regarding Claim 2, Lewis discloses all of the limitations of Claim 1. Lewis further discloses: wherein the first portion of the respiratory gas is air from a compressed gas source (Paragraph 0139, It is envisioned that high flow therapy system 2000 includes at least one compressed gas entry port 2090).
Regarding Claim 3, Lewis discloses all of the limitations of Claim 1. Lewis further discloses: wherein the first portion of the respiratory gas is ambient air (Paragraph 0117. Relating to the embodiment illustrated in FIG. 16, blower 2080 is used to draw in ambient air from air inlet port 2070 and force it through an air flow tube 2140, through gas inlet port 2040, through humidity chamber 2020 and through gas outlet port 2050 towards non-sealing respiratory interface 100).
Regarding Claim 4, Lewis discloses all of the limitations of Claim 1. Lewis further discloses: wherein the second portion of respiratory gas is oxygen (Paragraph 0118, As shown in FIGS. 16 and 17, oxygen flowing through oxygen flow tube 2150 mixes with ambient air (or filtered air) flowing through air flow tube 2140 in a mixing area 2155 prior to entering humidity chamber 2020).
Regarding Claim 5, Lewis discloses all of the limitations of Claim 1. Lewis further discloses: wherein the second manifold includes a gas inlet, a gas outlet, a first proportional valve, and a second proportional valve, wherein the first proportional valve and the second proportional valve are coupled in parallel between the gas inlet and the gas outlet (Paragraph 0150, FIGS. 32A and 32B illustrate a schematic diagram of a further embodiment of an HFT device which allows for relatively low percentage gas mixtures, for example low FiO2 when O2 is mixed with air […] The schematic illustrates how two proportional valves 2132 may be used to control flow over a wider range than would be effective with a single proportional valve)
PNG
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(Lewis, Annotated Figure 32B)
Regarding Claim 8, Lewis discloses all of the limitations of Claim 1. Lewis further discloses: further comprising a mixing area coupled to the first manifold and the second manifold, the mixing area configured to mix the first portion of the respiratory gas and the second portion of the respiratory gas (Paragraph 0118, As shown in FIGS. 16 and 17, oxygen flowing through oxygen flow tube 2150 mixes with ambient air (or filtered air) flowing through air flow tube 2140 in a mixing area 2155 prior to entering humidity chamber 2020).
Regarding Claim 11, Lewis discloses all of the limitations of Claim 8. Lewis further discloses: further comprising a port coupled to the mixing area, the port configured to couple to an oxygen analyzer (Paragraph 0124, As shown schematically in FIG. 17, the gas sample can be taken from a patient's upper airway via conduit 2130 or from mixing area 2155 via a sample line 2180 and a sample port 2182 (FIG. 16) […] The gas analyzer can compare measurements of the gas sample(s) with predetermined measurements to ensure high flow therapy device 2000 is working optimally)
Regarding Claim 12, Lewis discloses all of the limitations of Claim 1. Lewis further discloses: further comprising one or more filters coupled to a flow path of the high flow therapy system, the one or more filters having viral and/or anti-bacterial properties (Paragraph 0117, Additionally, an air intake filter 2072 (shown schematically in FIG. 17) may be provided adjacent air inlet port 2070 to filter the ambient air being delivered to the patient. It is envisioned that air intake filter 2072 is configured to reduce the amount of particulates (including dust, pollen, fungi (including yeast, mold, spores, etc.) bacteria, viruses, allergenic material and/or pathogens) received by blower 2080)
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.
Claims 6-7 and 9-10 are rejected under 35 U.S.C. 103 as being unpatentable over Lewis (US 20080142019 A1) in view of Niland et al. (US 20090090363 A1, hereinafter "Niland").
Regarding Claim 6, Lewis discloses all of the limitations of Claim 5. Lewis further discloses: wherein at least one of the first manifold and the second manifold further includes a regulator coupled between the gas inlet and the first and second proportional valves (Paragraph 0150, FIGS. 32A and 32B illustrate a schematic diagram of a further embodiment of an HFT device which allows for relatively low percentage gas mixtures, for example low FiO2 when O2 is mixed with air)
Lewis depicts a regulator in Figures 32A and 32B, and further discloses pressure sensing and adjusting the system to a predetermined pressure (Paragraph 0114, For example, if the pressure at the patient's upper airway is measured and determined to be too low (e.g., by a pre-programmed algorithm embedded on microprocessor 2060 or from a setting inputted by a operator), microprocessor 2060 may, for example, adjust the speed of blower 2080 and/or oxygen proportional valve 2100 so that sufficient pressure levels are maintained).
Though not explicitly stated, the system of Lewis is capable of being configured to reduce a pressure of gas received from a first source to a predetermined pressure and provide the gas to the first and second proportional valves.
However, if the Applicant is not convinced, Niland more explicitly discloses: wherein at least one of the first manifold and the second manifold further includes a regulator coupled between the gas inlet and the first and second proportional valves (Paragraph 0051, Gas input into base unit 110 is controlled by two proportional solenoids PSOL1, PSOL2 that regulate the flow of gas 50a, 50b, respectively, into base unit 110. Proportional solenoids PSOL1, PSOL2, respectively, to regulate gas input flow into base unit 110. Gas pressure sensors PS1, PS2 monitor gas pressure upstream of solenoids PSOL1, PSOL2, respectively. Check valves 51a, 51b direct gas flow into gas blending device 84 and prevent reverse flow of gas 50a, 50b), the regulator configured to reduce a pressure of gas received from a first source to a predetermined pressure and provide the gas to the first and second proportional valves (Paragraph 0052, Gas pressure sensor PS4 is coupled to a microcontroller (not shown) and monitors the pressure of the blended gas. If the blended gas pressure exceeds a certain safety threshold, humidification system 100 emits an audible and a visual alarm. Additionally, when gas pressure sensor PS4 senses a low pressure, gas flow is limited by system 100).
Both Niland and Lewis teach heated respiratory therapy devices with gas blending elements and proportional valves. Thus, it would have been obvious to one skilled in the art before the effective filing date to incorporate the teachings of the pressure regulating elements disclosed by Niland with the regulator and manifold arrangement depicted by Lewis. The regulator and sensors help maintain appropriate pressure throughout the system based on user comfort or respiratory therapy needs.
Regarding Claim 7, Lewis discloses all of the limitations of Claim 5. Lewis further discloses: wherein at least one of the first manifold and the second manifold further includes a flow sensor (Paragraph 0139, In an embodiment, it is envisioned that at least one gas flow sensor 2120 is disposed in electrical communication with the microprocessor 2060 and is configured to detect at least one flow characteristic of the gas), (Paragraph 0150, Also shown is how a single sensor may be configured to sense flow from two flow tubes (e.g., pneumotachs), in this instance, one for high and one for low volume flow)
Lewis does not explicitly disclose the position of the flow sensor to be between the gas outlet and the first and second proportional valves, but modifying the placement of and/or adding additional sensors is known in the art of controlled respiratory devices.
However, if the Applicant is not convinced, Niland discloses: wherein at least one of the first manifold and the second manifold further includes a flow sensor (Paragraph 0052, In an exemplary embodiment, gas flow rate of air 50a and oxygen gas 50b are monitored by mass flow sensor MFS1, MFS2, respectively, positioned on gas blending device 84) coupled between the gas outlet (Paragraph 0062, As shown in FIGS. 6A-6C, first portion 71 of gas blending device 84 includes sensor openings 76a, 76b which open into either end of passage 76c), (Paragraph 0063, Second portion 81 includes threaded inserts 89a, 89b to mount mass flow sensor MFS2 through openings 86a, 86b. Main gas outlet 68 provides an exit for blended gas to flow to gas outlet 649, shown in FIG. 8C, of base unit 110) and the first and second proportional valves (Paragraph 0051, Gas input into base unit 110 is controlled by two proportional solenoids PSOL1, PSOL2 that regulate the flow of gas 50a, 50b, respectively, into base unit 110. Proportional solenoids PSOL1, PSOL2, respectively, to regulate gas input flow into base unit 110)
Both Niland and Lewis teach heated respiratory therapy devices with gas blending elements and proportional valves. Thus, it would have been obvious to one skilled in the art before the effective filing date to incorporate the teachings of the flow sensor positioning disclosed by Niland with the regulator and manifold arrangement depicted by Lewis. The regulator and sensors help maintain appropriate flow rates throughout the system based on user comfort or respiratory therapy needs.
Regarding Claim 9, Lewis discloses all of the limitations of Claim 8. Lewis further discloses: further comprising a pressure sensor configured to measure pressure thereof (Paragraph 0117, It is also envisioned that a pressure sensor is disposed adjacent air intake filter 2072 (shown schematically in FIG. 17), (Paragraph 0119, In a disclosed embodiment, sensor 2120 measures both inspiration pressure and expiration pressure of the patient. In the embodiment illustrated in FIGS. 18 and 19, conduit 2130 delivers the pressure measurements to sensor 2120 (not explicitly shown in FIGS. 18 and 19), which may be disposed adjacent microprocessor 2060).
Lewis does not explicitly disclose the position of the pressure sensor to be coupled to the mixing area, but modifying the placement of and/or adding additional sensors is known in the art of controlled respiratory devices.
However, if the Applicant is not convinced, Niland more explicitly discloses: a pressure sensor coupled to the mixing area and configured to measure pressure thereof (Paragraph 0052, Air 50a and oxygen gas 50b are blended in gas blending device 84 and blended gas pressure is monitored by gas pressure sensor PS4 […] Gas pressure sensor PS4 is coupled to a microcontroller (not shown) and monitors the pressure of the blended gas. If the blended gas pressure exceeds a certain safety threshold, humidification system 100 emits an audible and a visual alarm. Additionally, when gas pressure sensor PS4 senses a low pressure, gas flow is limited by system 100)
Both Niland and Lewis teach heated respiratory therapy devices with gas blending elements and proportional valves. Thus, it would have been obvious to one skilled in the art before the effective filing date to incorporate the teachings of the pressure regulating elements disclosed by Niland with the gas blender arrangement depicted by Lewis. The sensors help detect and maintain appropriate pressure throughout the system based on user comfort or respiratory therapy needs.
Regarding Claim 10, Lewis discloses all of the limitations of Claim 8. Lewis depicts a relief valve coupled to the mixing area in Figures 32a and 32B, and discloses adjusting the system if it exceeds a certain pressure (Paragraph 0116, For example, if the pressure at the patient's upper airway is measured and determined to be too low (e.g., by a pre-programmed algorithm embedded on microprocessor 2060 or from a setting inputted by a operator), microprocessor 2060 may, for example, adjust the speed of blower 2080 and/or oxygen proportional valve 2100 so that sufficient pressure levels are maintained)
Though not explicitly stated, the system of Lewis is capable of vent[ing] the respiratory gas if pressure in the mixing area exceeds a certain pressure.
However, if the Applicant is not convinced, Niland more explicitly discloses: a relief valve coupled to the mixing area, wherein the relief valve is configured to vent the respiratory gas if pressure in the mixing area exceeds a certain pressure (Paragraph 0058, Blending channel 73c leads to main terminal channel 73d where blended gas may exit through second portion 81 and flow to a gas outlet, shown as gas outlet 649 in FIG. 8C, of base unit 110. Upstream of main terminal channel 73d is a pressure relief outlet 74c that functions as a secondary gas exit if gas pressure exceeds a predetermined value. In an exemplary embodiment, pressure relief outlet 74c is part of a pressure relief valve system, which may open or close pressure relief valve 91 (shown schematically in FIG. 5), depending on gas pressure within gas blending device 84).
Both Niland and Lewis teach heated respiratory therapy devices with gas blending elements and proportional valves. Thus, it would have been obvious to one skilled in the art before the effective filing date to incorporate the teachings of the pressure-regulating relief valve disclosed by Niland with the therapy system depicted by Lewis. The relief valve helps to maintain appropriate pressure throughout the system based on user comfort or respiratory therapy needs. The structural arrangement of the relief valve in relation to the gas blending elements, as described by Niland, provides further clarity on how the valve element depicted by Lewis was intended to be incorporated into the overall therapy system.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure
Schnitzer et al. (US 5692497 A) discloses a microprocessor-controlled ventilator system with flow-regulating elements
White et al. (US 20160193438 A1) discloses a non-sealing respiratory flow system
Acker et al. (US 20150320953 A1) discloses a therapeutic gas delivery system with a gas blending device
Wilt et al. (US 20130037485 A1) discloses a fluid flow circuit for dialysis and hemodialysis systems
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MISHAL HUSSAIN whose telephone number is (703)756-1206. The examiner can normally be reached M-F, 8:30am - 5:00pm.
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 S. 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.
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/MISHAL HUSSAIN/
Examiner
Art Unit 3785
/BRANDY S LEE/Supervisory Patent Examiner, Art Unit 3785
Prosecution Insights