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(s) filed on 03/23/2024 is/are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement(s) is/are being considered by the examiner.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the connector of claim 4 and differential pressure sensor, air pressure sensor and first, second and third portion of claim 8 must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Rejections - 35 USC § 112
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.
Claim(s) 1-8 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.
Claim 1, line 3, recites “…and valves configured to resist outflow of expired gases…” and further discusses a continuous expiratory airway resistance valve and an inspiration valve but it is unclear whether or not the valves configured to resist outflow of expired gases is the expiratory airway resistance valve and inspiration valve or is another valve(s). The specification recites “the CEAR valve comprises a tube-within-tube (12, 14) design with dedicated channels for inspired and expired gases facilitated by valves (2, 3); this resists outflow of expired gases (see [0054)” and further discusses the Continuous Expiratory Airway Resistance Valve to be valve 2 and the inspiratory valve to be valve 3 as seen in [0057]-[0058]. For examination purposes, as best understood, the valves configured to resist outflow of expired gases are the continuous expiratory airway resistance valve and inspiration valve.
Claims 2-8 are rejected as they depend from and therefore incorporate the claimed subject matter rejected under this statute.
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) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived 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.
Claim(s) 1-3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Xiao (CN 107899201 A; machine translated 7/29/2026).
Regarding claim 1, Xiao teaches a respiratory system (Xiao teaches a parallel inhalation and exhalation breathing training apparatus as seen in Figs. 1-7 and page 4, lines 4-7) comprising:
a tube-within-tube (outer cylinder 1 and outer screw sleeve 2, see Fig. 1) having an outer cylinder tube (outer cylinder 1, see Fig. 1) for expired air flow (Xiao teaches expired gas to pass through exhalation valve core 10 as seen in page 5, paragraphs 2-4 which is within outer cylinder 1 as seen in Fig. 1) and an inner cylinder (outer screw sleeve 2, see Fig. 1) tube for inspired air flow (Xiao teaches external gas to be sucked into the lungs through inhalation valve core 4 which is within outer screw sleeve 2 as seen in Fig. 1 and page 4, fourth paragraph) and valves (inhalation valve core 4, exhalation pressure regulating spring 5, inspiratory pressure adjustment spring 6 and exhalation valve core 10, see Fig. 1) configured to resist outflow of expired gases (inspired air flows through outer screw sleeve 2 and expired air flows through outer cylinder 1 as seen in Fig. 1 and page 4, paragraph 4 and page 5, paragraphs 2-4 (similar to paragraph [0023] of applicant’s specification));
a continuous expiratory airway resistance valve (exhalation pressure regulating spring 5 and exhalation valve core 10, see Fig. 1) that is cylindrical and co-axial with the outer cylindrical tube and the inner cylindrical tube (exhalation valve core 10 is cylindrical and co-axial with outer cylinder 1 and outer screw sleeve 2 as seen in Fig. 1), wherein the continuous expiratory airway resistance valve is an adjustable, spring-loaded, resistance unidirectional valve configured to generate pressure to gas flow and maintain a set resistance during time of post-expiratory pause and configured to open only during expiration and to close during inspiration so as to provide a first dedicated channel for expiration, and wherein the continuous expiratory airway resistance valve provides an adjustable level of resistance (Xiao teaches expired gas to pass through exhalation valve core 10 and outer screw sleeve 2, wherein the exhalation valve core 10 is a one-way valve controlled by exhalation pressure regulation spring 5 as seen on Fig. 1 and page 5, paragraphs 2-4. The regulation spring 5 acts on the valve core 10 until the exhalation pressure is great enough to open the exhalation valve core 10, allowing gas exhaled from the oral cavity to the outside atmospheric environment. The exhalation pressure regulation spring 5 can have the exhalation resistance be adjusted as seen on page 5, paragraphs 2-4);
an inspiration valve (inhalation valve core 4 and inspiratory pressure adjustment spring 6, see Fig. 1) that is a unidirectional valve (see Fig. 1 and page 4, paragraph 4 and page 5, paragraph 2), wherein the inspiration valve is inside the inner cylinder tube (the inhalation valve core 4 is within outer screw sleeve 2 as seen in Fig. 1), wherein the inspiration valve is configured to open only during inspiration and to close during expiration so as to provide a second dedicated channel for inspiration (Xiao teaches external air to be sucked in through suction valve core 4 when it is moved to the right due to the suction power of inhalation as seen on page 4, paragraph 4. Furthermore, Xiao teaches the one-way valve formed by suction valve core 4 does not allow exhalation gas to be discharged, it can only travel through the exhalation valve core 10 as seen on page 5, paragraph 2), and wherein the continuous expiratory airway resistance valve is configured such that all the expired gas passes through only the outer cylinder tube housing the spring-loaded adjustable valve during expiration (Xiao teaches the one-way valve formed by suction valve core 4 does not allow exhalation gas to be discharged and it can only travel through the exhalation valve core 10 as seen on page 5, paragraph 2)
but does not teach the inspiration valve to be located at a patient end of the tube-within-tube but does teach the patient end to be where mouthpiece 12 lies in Fig. 1.
With respect to Claim 1, Xiao does not explicitly teach the inspiration valve to be located at a patient end of the tube-within-tube. However, it has been held that the mere rearrangement of parts does not constitute a patentable improvement in the art when said rearrangement does not result in a non-obvious change in functionality (see MPEP § 2144.04. VI. C.). In this case, it is unclear why repositioning the inspiration valve to be located at a patient end of the tube-within-tube would substantially change the functionality of the device in a non-obvious way. Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the instant application to modify Xiao to have the inspiration valve to be located at a patient end of the tube-within-tube, since it has been held that the rearrangement of parts involves only routine skill in the art.
Regarding claim 2, Xiao teaches the system of claim 1, and further teaches wherein the continuous expiratory airway resistance valve is a unidirectional valve (Xiao teaches the exhalation valve core 10 is a one-way valve controlled by exhalation pressure regulation spring 5 as seen on Fig. 1 and page 5, paragraphs 2-4).
Regarding claim 3, Xiao teaches the system of claim 1, and further teaches wherein the outer cylinder tube is spaced apart from the inner cylinder tube, wherein a mouth of the inner cylinder tube abuts a mouth of the outer cylinder tube, and wherein the inner cylinder tube is co-axial with the outer cylinder tube (Fig. 1 shows outer cylinder 1 is spaced apart from outer screw sleeve 2, wherein a mouth of outer screw sleeve 2 abuts a mouth of outer cylinder 1 (see where reference 2 is pointed towards) and the outers screw sleeve 2 is co-axial with outer cylinder 1).
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Xiao (CN 107899201 A; machine translated 7/29/2026) and Sloan (US 6484724 B1).
Regarding claim 4, Xiao teaches the system of claim 1, but does not teach further comprising:
a connector configured to connect to a patients tracheostomy outer end with incentive spirometry, wherein the connector is a universal female adapter.
However, Sloan teaches a connector (adaptor 10, see Fig. 2) configured to connect to a patients tracheostomy outer end with incentive spirometry (adaptor 10 has a patient end 12 and a machine end 14 as seen in Col. 3, lines 23-58 and can connect to both a facemask and a tracheal tube as seen in Col. 1, lines 6-10 and 22-32), wherein the connector is a universal female adapter (Sloan teaches a universal adaptor with a female port as seen in Col. 3, lines 31-58).
Xiao teaches a mouthpiece 12 that is connected to the end cap 11 and can be disassembled as seen in Fig. 1 and page 3, paragraph 1. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the system taught by Xiao to include a connector as taught by Sloan for a universal adaptor that can be used to rapidly connect and disconnect pieces of equipment to allow connections to a mask or a tracheal tube (see Col. 2, lines 11-16).
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Xiao (CN 107899201 A; machine translated 7/29/2026) and Hoenig (US 6135108 A).
Regarding claim 5, Xiao teaches the system of claim 1, but does not teach wherein the continuous expiratory airway resistance valve is configured to instill pressure to the gas flow ranging from 3 cm H2O to 30 cm H2O.
However, Hoenig teaches PEEP valve 50 is provided with an internal valve, or relief valve such as a spring biased flapper valve that is set to open and close between 2.5 to 20 cm H2O, such that the valve will not open until the exhalation gas from a patient reaches the valve setting as seen in Fig. 4 and Col. 3, lines 50-61.
Xiao teaches exhalation valve core 10 with exhalation pressure regulating spring 5 as seen in Fig. 1 and page 5, paragraphs 2-4, but is silent on the pressure ranges. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the system taught by Xiao to have the expiratory resistance valve instill pressure to the gas flow ranging from 2.5 to 20 cm H2O as taught by Hoenig as a known range of pressure used for an exhaust valve within the art.
However, Xiao in view of Hoenig does not explicitly teach the continuous expiratory airway resistance valve is configured to instill pressure to the gas flow ranging from 3 cm H2O to 30 cm H2O.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the range of pressure of Xiao in view of Hoenig from between 2.5 to 20 cm H2O to be between 3 to 20 cm H2O as applicant appears to have placed no criticality on the claimed range ([0056] of applicant’s specification only recites what is within the claims without placing criticality on a reason and [0057] states the spring-based pressure is to only generate a minimum of 3 cm H2O pressure (resistance) to gas flow) and since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists”. In re Wertheim, 541F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed.Cir. 1990).
Claim(s) 6-7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Xiao (CN 107899201 A; machine translated 7/29/2026) and Lurie (US 20210386961 A1).
Regarding claim 6, Xiao teaches the system of claim 1, but does not teach wherein the inspiration valve is a fish mouth valve for inspiration.
However, Lurie teaches wherein the inspiration valve is a fish mouth valve for inspiration (Lurie teaches an inspiratory resistor valve with expiratory port use to regulate intrathoracic pressure of a patient, wherein the one-way valve can be the form of check valves, fish mouth valves, spring valves and ball valves and/or other mechanical or electronically controlled valves as seen in Fig. 1A and [0039]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the system taught by Xiao to replace the inspiration valve with a fish mouth valve as taught by Lurie for an alternative one-way inspiratory valve which would perform a similar function.
Regarding claim 7, Xiao teaches the system of claim 1, but does not teach wherein the inspiration valve is a ball valve for inspiration.
However, Lurie teaches wherein the inspiration valve is a ball valve for inspiration (Lurie teaches an inspiratory resistor valve with expiratory port use to regulate intrathoracic pressure of a patient, wherein the one-way valve can be the form of check valves, fish mouth valves, spring valves and ball valves and/or other mechanical or electronically controlled valves as seen in Fig. 1A and [0039]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the system taught by Xiao to replace the inspiration valve with a ball valve as taught by Lurie for an alternative one-way inspiratory valve which would perform a similar function.
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Xiao (CN 107899201 A; machine translated 7/29/2026), Perez (US 20160242675 A1) and Kagan (US 20180177961 A1).
Regarding claim 8, Xiao teaches the system of claim 1, and further teaches a first port (third air hole 23, see Fig. 1), second port (first air hole 21, see Fig. 1) and a third port (second air hole 22, see Fig. 1), wherein the third port is at a level of the first port (Xiao teaches the outer screw sleeve with a first airhole 21 at one end and a second air hole 22 at the other end and a third air hole 24 is on the convex ring as seen in Fig. 1 and page 1, last paragraph and page 2, first paragraph) but does not teach further comprising:
a differential air pressure sensor between a first port and a second port, wherein the first port is a proximal port of the differential air pressure sensor, wherein the second port is a distal port of the differential air pressure sensor spaced apart from the proximal port, wherein the differential air pressure sensor is configured to measure two different readings of pressure created by created by flow of air during exhalation;
an air pressure sensor configured to measure gauge pressure at a third port at a level of the first port; and
a microcontroller configured to receive data from the differential air pressure sensor and the air pressure sensor to monitor the flow rate measurements and the gauge pressure readings in real time.
However, Perez teaches a differential air pressure sensor (differential pressure sensor 1111, see Fig. 2 and [0034] and [0036]) between a first port (second pneumatic input port 1113, see Fig. 2) and a second port (first pneumatic input port 1112, see Fig. 2) (see Fig. 2 and [0035]), wherein the first port is a proximal port of the differential air pressure sensor, wherein the second port is a distal port of the differential air pressure sensor spaced apart from the proximal port (differential pressure sensor 1111 is closer to second pneumatic input port 1113 and further from first pneumatic input port 1112, wherein first pneumatic input port 1112 is spaced apart from second pneumatic input port 1113 as seen in Fig. 2);
a microcontroller (computer device 12 and processor 122, see Fig. 1) configured to receive data from the differential air pressure sensor to monitor the flow rate measurements (“The processor 122 provided as part of the computer device 12 is configured to measure the respiratory rate of the patient based on variations in the flow/pressure of gas in the pipe (i.e. using the data provided by the sensor unit 11), and to implement a trend analysis of the respiratory rate measured over a period of time.” See [0033]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the system taught by Xiao to include a differential air pressure sensor and computer device as taught by Perez to measure the flow of gas/pressure to assure the patient’s health is not deteriorating based on the trend analysis of the flow/pressure (see [0033]). Xiao in view of Perez teaches wherein the differential air pressure sensor is configured to measure two different readings of pressure created by created by flow of air during exhalation (Xiao teaches a first port (third air hole 23, see Fig. 1) and second port (first air hole 21, see Fig. 1) and Perez teaches differential pressure sensor 1111 measuring between the two ports. As such, Xiao in view of Perez teaches differential pressure sensor 1111 (of Perez) measuring two different readings of pressure created by the flow of air during exhalation due to the locations of the third air hole 23 and first air hole 21).
However, Kagan teaches an air pressure sensor (pressure sensor 5, see Fig. 1) configured to measure gauge pressure within a conduit (pressure sensor 5 is to measure the inlet pressure of oxygen within oxygen duct 20 as seen in Fig. 1 and [0041] and [0020]); and
a microcontroller configured to receive data from air pressure sensor to monitor the gauge pressure readings in real time (Kagan teaches a microprocessor to adjust flow rates, pressures and more from the inlet pressure from the sensors as seen in [0046] and [0048]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the system taught by Xiao in view of Perez to include a pressure sensor and microprocessor as taught by Kagan to measure the inlet pressure (see [0041]) as another point of data to look at and monitor for patient health.
However, Xiao in view of Perez and Kagan does not explicitly teach an air pressure sensor at a third port at a level of the first port. But it has been held that the mere rearrangement of parts does not constitute a patentable improvement in the art when said rearrangement does not result in a non-obvious change in functionality (see MPEP § 2144.04. VI. C.). In this case, it is unclear why repositioning air pressure sensor to be located at the third port would substantially change the functionality of the device in a non-obvious way. Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the instant application to modify Xiao in view of Perez and Kagan to have the air pressure sensor to be located the third port, since it has been held that the rearrangement of parts involves only routine skill in the art. Furthermore, Kagan teaches the air pressure sensor to measure inlet pressures and second air hole 22 would be where external gas enters.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Higashiyama (US 20190282771 A1) teaches a differential pressure sensor across two ports.
Chalvignac (US 9923442 B2) teaches a breathing assistance device with a valve.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Tina Zhang whose telephone number is (571)272-6956. The examiner can normally be reached Monday - Friday 9:00AM-5:00PM.
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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.
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/TINA ZHANG/Examiner, Art Unit 3785
/BRANDY S LEE/Supervisory Patent Examiner, Art Unit 3785
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