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 08/22/2023 and 04/10/2024 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.
Election/Restrictions
Claim(s) 7 is withdrawn (and claims 3 and 8-10 have been cancelled) from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Species B/C, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 05/19/2026.
Furthermore, claims 1, and 15-16 have been amended. As such, claims 1-2,4-6 and 11-16 are being examined in the current application.
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.
Claim(s) 1-2 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Dantanarayana (US 20040094157 A1).
Regarding claim 1, Dantanarayana teaches a patient interface (breathing mask shell 32, see Fig. 7 and [0022] and [0071]) comprising a plenum chamber (Breathing mask shell 32 comprises a plenum chamber as breathing mask shell 32 covers the mouth and/or nose of the patient 50 and operates with the flow regulation vent to regulate pressure as seen in Fig. 7 and [0070]-[0071] (similar to applicant’s plenum chamber in Figs. 7A-7B)) and a valve, or a plurality of valves, (flow regulation vent/valve 10, see Figs. 1-7 and [0028] and [0070]) wherein the or each valve is in fluid communication with the plenum chamber (Dantanarayana teaches gas to transfer from mask shell 32 to flow regulation vent 10 to the atmosphere as seen in [0071]-[0073]), the or each valve comprising a valve member (movable portion 12, see Figs. 1-3) and a valve seat portion (fixed portion 14, see Figs. 1-3), wherein the or each valve member is biased away from the seat portion and is configured to close when a pressure within the plenum chamber exceeds a predetermined valve closing pressure (Dantanarayana teaches movable portion 12 to be biased by the force of springe hinge 16 into a relaxed position away from fixed portion 14 as seen in Fig. 3 and for movable portion 12 to move towards fixed portion 14 as CPAP pressure within the mask increases as seen in Fig. 2 and [0073]-[0074]), and
wherein the valve member comprises a plurality of apertures configured to form a vent when the valve member is closed (movable portion 12 includes one or more bleed orifices 24 as seen in Fig. 1, that is configured to vent when movable portion 12 is in a fully pressurized position as shown in Fig. 2 and 0070]).
Regarding claim 2, Dantanarayana teaches the patient interface of claim 1, and further teaches wherein only one valve is provided (Dantanarayana teaches a single flow regulation vent/valve 10 as seen in Figs. 1-7).
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) 4 -5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dantanarayana (US 20040094157 A1) in view of Rapoport (US 20140000610 A1).
Regarding claim 4, Dantanarayana teaches the patient interface of claim 2, but does not teach wherein the valve member is configured to close when a pressure within the plenum chamber exceeds 1 cmH2O.
However, Rapoport teaches wherein the valve member (Rapoport teaches a valve 250 with a valve member movable between two positions as seen in Fig. 2 and [0074] and [0129]) is configured to close when a pressure within the plenum chamber exceeds 1 cmH2O (Rapoport teaches the valve is stable and closed when there is a mask pressure of about 1.7 cm H2O as seen in [0239]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the patient interface taught by Dantanarayana to have the valve member close when the pressure within the plenum chamber is 1.7 cmH2O as taught by Rapoport as a known data point for mask pressure used for a closed and stable valve that performs similarly to the valve taught by Dantanarayana (see [0074], [0124] and [0239]).
Regarding claim 5, Dantanarayana teaches the patient interface of claim 2, but does not teach wherein the valve member is configured to close when a pressure within the plenum chamber exceeds 0.5 cmH2O.
However, Rapoport teaches wherein the valve member (Rapoport teaches a valve 250 with a valve member movable between two positions as seen in Fig. 2 and [0074] and [0129]) is configured to close when a pressure within the plenum chamber exceeds 0.5 cmH2O (Rapoport teaches the valve is stable and closed when there is a mask pressure of about 1.7 cm H2O as seen in [0239]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the patient interface taught by Dantanarayana to have the valve member close when the pressure within the plenum chamber is 1.7 cmH2O as taught by Rapoport as a known data point for mask pressure used for a closed and stable valve that performs similarly to the valve taught by Dantanarayana (see [0074], [0124] and [0239]).
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dantanarayana (US 20040094157 A1) in view of Doshi (US 20070277832 A1).
Regarding claim 6, Dantanarayana teaches the patient interface of claim 2, and Dantanarayana further teaches wherein the valve member is configured to reduce the flow area through the valve in proportion to an increase in pressure in the plenum chamber (Dantanarayana teaches movable portion 12 to be biased away from fixed position 14 as seen in Fig. 2 and [0073]. However, as CPAP pressure increases, the movable portion 12 will move towards fixed portion 14 due to the increasing pressures, resulting in reduced flow area as seen in [0074])
But does not teach wherein the valve member is configured to reduce the flow area through the valve in proportion to an increase in pressure in the plenum chamber over a plenum chamber pressure range of 0 cmH2O to 4 cmH2O.
However, Doshi teaches when the valve is in the closed position, the pressure across the flap valve is between 3 and 15 cmH2O.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the patient interface taught by Dantanarayana to have the valve be closed when the pressure is between 3 and 15 cmH2O as taught by Doshi as a known flap closed pressure with leak holes (see [0102]).
However, Dantanarayana in view of Doshi does not expressly disclose the valve member is configured to reduce the flow area over a plenum chamber pressure range of 0cmH2O to 4cmH2O as required by the claim.
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 closing pressure of the valve Dantanarayana in view of Doshi to be from between 3 and 15 cmH2O to 4 cmH2O as applicant appears to have placed no criticality on the claimed range (see [0164], wherein the valves may close when the pressure reaches 1 cmH2O or 2 cmH2O) 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, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). Dantanarayana in view of Doshi teaches wherein the valve member is configured to reduce the flow area through the valve in proportion to an increase in pressure in the plenum chamber over a plenum chamber pressure range of 0 cmH2O to 4 cmH2O (Doshi teaches the closing pressure to be 4 cmH2O. Therefore, Dantanarayana in view of Doshi teaches moving portion 12 to reduce the flow area as pressures increase from 0 to 4 cm H2O, as moving portion 12 moves towards fixed portion 14 to be closed as seen in Fig. 3 and [0074]).
Claim(s) 11-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dantanarayana (US 20040094157 A1) in view of Cragg (US 20140246024 A1).
Regarding claim 11, Dantanarayana teaches the patient interface of claim 1, but does not teach wherein the or each valve seat portion is constructed from a soft material.
However, Cragg teaches wherein the or each valve seat portion (valve seat seal 434, see Figs. 21A-21B) is constructed from a soft material (Cragg teaches valve seat seal 434 to have a material having a durometer of at least 10 A as seen in [0256]).
Dantanarayana teaches the flow regulation vent to reduce the operating noise of the CPAP system (see [0026], [0071] and [0080]). Dantanarayana further teaches using other materials for vent 10 can exhibit the desired combination of rigidity, flexibility, springiness and resistance as seen in [0078]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the patient interface taught by Dantanarayana to have the valve seat portion be of a material having a durometer of at least 10 A as taught by Cragg as a known softness/hardness used for a valve within the art which will aid in reducing noise if the valve member is to contact the valve seat portion.
Regarding claim 12, Dantanarayana in view of Cragg teaches the patient interface of claim 11, and further teaches wherein the valve seat portion is constructed from a material having a Shore A Durometer hardness of less than 40 (Dantanarayana in view of Cragg teaches fixed portion 14 of Dantanarayana to have a durometer of at least 10A (taught by Cragg) which is less than 40).
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dantanarayana (US 20040094157 A1) in view of Cragg (US 20140246024 A1), and further in view of Martin (US 20090133700 A1).
Regarding claim 13, Dantanarayana in view of Cragg teaches the patient interface of claim 11, but does not teach wherein the valve seat portion is constructed from foam.
However, Martin teaches wherein the valve seat portion (seal surface 34, see Fig. 3) is constructed from foam (“The seal surface may, e.g., be in the form of a coating, a film, a ring such as an O-ring, or a foam such as a cellular, closed cell foam.” See [0123]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the patient interface taught by Dantanarayana in view of Cragg to have the valve seal portion be constructed as foam as taught by Martin as a material within the art that is known to be soft and for the resiliency (see [0123]).
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dantanarayana (US 20040094157 A1) in view of Tobia (US 20220160989 A1).
Regarding claim 14, Dantanarayana teaches the patient interface of claim 1, but does not teach wherein at least one of the valves is an electrically actuated valve.
However, Tobia teaches a pressure regulator can be any suitable pressure-reducing valve (including a membrane-based) that can be set electronically or by mechanical means as seen in [0026]). Tobia further teaches expiratory valve 74 is an electronically-controlled normally open valve which shifts, responsive to a control signal from controller as seen in Fig. 2 and 3B and [0029] and [0031].
Dantanarayana teaches attaching a strain gauge 60 between movable portion 12 and the fixed portion 14 and a processor as seen in [0087]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the patient interface taught by Dantanarayana to have the valve be an electrically actuated valve as taught by Tobia as a pressure-reducing valve can be either electronic or mechanical.
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dantanarayana (US 20040094157 A1) in view of Klasek (US 20140144438 A1).
Regarding claim 15, Dantanarayana teaches the patient interface of claim 1, and further teaches wherein the patient interface comprises a sensor (Dantanarayana teaches attaching a strain gauge 60 between movable portion 12 and the fixed portion 14 and a processor as seen in [0087])
but does not teach wherein the patient interface comprises a sensor configured to sense a characteristic of the air within the plenum chamber, wherein the characteristic is indicative of whether a patient wearing the patient interface is asleep.
However, Klasek teaches wherein the patient interface comprises a sensor configured to sense a characteristic of the air within the plenum chamber (“The sensors may be located for example, proximate to the patient interface (e.g., in or at the mask) and/or proximate to each ion generator. The controller may detect or measure the level of ions or anions in the breathable gas generated based on a signal from one or more of such sensor(s).” see [0061] and [0060]), wherein the characteristic is indicative of whether a patient wearing the patient interface is asleep (Klasek teaches by analyzing the signal from a sensor, the controller can determine a respiratory rate in which if the respiratory rate falls below a pre-set threshold rate, the user is asleep as seen in [0079]).
Dantanarayana teaches a system to use in treatment for obstructive sleep apnea and similar sleep disordered breathing conditions as seen in [0003]. 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 patient interface taught by Dantanarayana to include the sensor and controller as taught by Klasek to aid in determining if the user is asleep (see [0079]).
Claim(s) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dantanarayana (US 20040094157 A1) in view of Lalonde (US 20120304985 A1).
Regarding claim 16, Dantanarayana teaches the patient interface of claim 1, but does not teach wherein the patient interface comprises a sensor configured to sense an orientation of the patient interface to determine, in use, whether a patient wearing the patient interface is lying on their back or on their side.
However, Lalonde teaches wherein the patient interface (mask 44, see Fig. 3) comprises a sensor (accelerometer 282, see Fig. 3) configured to sense an orientation of the patient interface to determine, in use, whether a patient wearing the patient interface is lying on their back or on their side (Lalonde teaches accelerometer 282 within the mask (see Fig. 3 and [0021]), wherein the accelerometer determines if the mask is in a certain orientation as seen in Fig. 11 and [0090]. Therefore, accelerometer 282 can determine if the patient interface/patient has moved).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the patient interface taught by Dantanarayana to include the accelerometer and controller as taught by Lalonde to determine if the patient interface has moved from its original location to provide data on how restless a patient is or/and if there are possible leaks due to the movement of the mask.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Radko (US 6230708 B1) teaches the valve of the chamber to be connected to the exhalation valve that moves from an open to closed position due to pressure.
Leeflang (US 20170028162 A1) teaches the valve membrane to be formed of polymer foams.
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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