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 .
Response to Amendment
The following section is in reference to the Applicant’s Arguments, filed July 02, 2025
Applicant’s arguments with respect to Claims 1-8 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Claim Rejections - 35 USC § 102/103
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.
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.
Claim 1 is rejected under 35 U.S.C. 102(a)(2) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Hely et al. (WO 9826830 A1, hereinafter “Hely”).
Regarding Claim 1, Hely discloses: A connector apparatus (Page 4, lines 21-23, Figure 1 is a general schematic drawing of a system comprising a flow generator being connected to a valve and mask via tubing in which the mask is connected to a patient), comprising:
a mask connector member to be secured to a mask to govern fluid flow through a vent in the mask (Page 9, lines 11-13, Figures 14 and 15 illustrate embodiments which incorporate the valve 14 into the mask 16. These embodiments have the advantage of not needing to make the additional connections of the airflow tube between the mask and the valve), the mask connector member forming a mask fluid flow passage through the vent between an external inlet and an internal outlet (Page 6, lines 18-25, The normal air flow for the valve 14 shown in Figures 2 and 3 A comes from the flow generator from the direction of the flow generator housing 22 wherein it passes through the flow generator housing 22, through valve element 24 through mask housing 26 and into tube 28)
the mask connector member including a mask valve received in the mask fluid flow passage (Figure 14, valve element 24), the mask valve movable between
a rest position in which the mask fluid flow passage is blocked by the mask valve (Page 8, lines 9-11, Figure 4A illustrates the slider valve element 24 wherein the airflow from the flow generator has diminished to the point where it does not override the attractive or biasing force pulling the slider valve element 24 closed) and
an actuated position in which the mask fluid flow passage is unblocked by the mask valve (Page 7, lines 3-5, The slider element 24 has at least two positions. The two positions are shown in Figures 3A and 4A. In Figure 3A, slider valve element 24 is forced open by the airflow)
the mask connector member further including a biasing member biasing the mask valve towards the rest position to block a fluid flow (Page 8, lines 11-16, What occurs in Figures 4 and 4A is the force of the air which had originally been pushing on base plate 39 keeping the valve 14 open has decreased to a point such that the attraction of the two magnets 36 and 38 is not overcome anymore. The slider valve 24 then moves to the left, thereby closing off the ability of the air to flow freely between the flow generator and the mask) from a fluid hose (Figure 2, air flow tube 12) through the mask fluid flow passage (Page 7, lines 1-2, The airflow comes through tube 12, into flow generator housing 22, whereby it enters the slider element portion of the valve 24);
and a hose connector member (Figure 14, flow generator housing 22) to be secured to the fluid hose the hose connector member forming a hose fluid flow passage between a hose inlet and a mask outlet (Page 6, lines 21-28, The normal air flow for the valve 14 shown in Figures 2 and 3 A comes from the flow generator from the direction of the flow generator housing 22 wherein it passes through the flow generator housing 22, through valve element 24 through mask housing 26 and into tube 28 wherein the air flows into the mask shown as 16 in Figure 1),
the hose inlet shaped to receive the fluid flow from the fluid hose when the fluid hose is secured to the hose connector member (Figure 14, Page 7, lines 1-2, The airflow comes through tube 12, into flow generator housing 22, whereby it enters the slider element portion of the valve 24)
the mask outlet shaped to form a sealed connection with the external inlet of the mask connector member to supply the fluid flow to the external inlet of the mask connector member when the hose connector member is coupled to the mask connector member (Figure 14, Page 12, lines 9-13, A valve having a first end and a second end, said first end secured to a flexible tubing which in turn is secured to a means to deliver a breathing gas, said second end secured to a breathing mask which is secured to a patient, said valve, means to deliver a breathing gas, and tubing defining a system which in a first operational mode is a substantially closed system)
the hose connector member including a valve actuator to move the mask valve to the actuated position when the hose connector member is coupled to the mask connector member (Page 7, lines 3-8, The two positions are shown in Figures 3A and 4A. In Figure 3A, slider valve element 24 is forced open by the airflow. The airflow overcomes the force generated by, in the preferred embodiment, magnets located at 36 and 38. The magnetic force imparted to the slider element 24 by magnets 36 and 38 is a very slight force, which is overcome by the flow of air shown in Figure 3A) to unblock the fluid flow through the mask fluid flow passage for supplying the fluid flow from the fluid hose to the vent in the mask (Pages 6-7, lines 28-1, This airflow is best shown in Figure 3 A wherein the arrows indicate the airflow)
Regarding Claim 2, Hely discloses all of the limitations of Claim 1. Hely further discloses: wherein the mask valve includes a first magnetic element and the valve actuator includes a second magnetic element configured to attract the first magnetic element to draw the mask valve from the rest position to the actuated position (Figures 12-13, Page 8, lines 11-19, What occurs in Figures 4 and 4A is the force of the air which had originally been pushing on base plate 39 keeping the valve 14 open has decreased to a point such that the attraction of the two magnets 36 and 38 is not overcome anymore. The slider valve 24 then moves to the left, thereby closing off the ability of the air to flow freely between the flow generator and the mask. In the preferred embodiment, both 36 and 38 are magnets. However, as described above, there are many options, and the other options would be that one of the elements, e.g., 36 would be a magnet wherein element 38 would merely be some material capable of being attracted to a magnet, such as iron, or an iron composite)
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Hely Annotated Figure 5
Regarding Claim 3, Hely discloses all of the limitations of Claim 2. Hely discloses the mask connector as being incorporated in the mask (Page 9, lines 11-13, Figures 14 and 15 illustrate embodiments which incorporate the valve 14 into the mask 16. These embodiments have the advantage of not needing to make the additional connections of the airflow tube between the mask and the valve), but does not explicitly disclose what sealing assemblies are incorporated in the structure.
Gunaratnam does disclose wherein the mask connector includes:
an inner assembly to seal against an inner surface of the face mask around an inner periphery of the vent (Figure 1, mating portion 22), (Column 2, lines 37-48, The mask 10 includes a circular aperture 12 sized to receive a mating portion 22 of the vent/connector piece 28. The mating portion 22 has an annular groove 23 formed therein that receives a locking means 30 in the form of a C-shaped clip attached after mating to the mask. The clip 30 has an outside diameter greater than the width of the aperture 12 and an inner diameter adapted to ensure a snug fit within the annular groove 23 ... As shown in FIG. 1, the clip 30 is located onto the mating portion 22 or, the inside of the mask 10);
and an outer assembly to seal against an outer surface of the face mask around an outer periphery of the vent (Column 3, lines 12-20, The corresponding surface is an annulus 50 having a protruding rim 51 the outer circumference of which preferably engages the inner surface of the detents 42 on insertion of the mating portion 22 into the aperture 12. This engagement prevents the detents from being pushed radially inwards sufficiently for the detents to disengage from behind the slot-forming formations 44, thus preventing the elbow 26 and vent/connector piece 28 from separating whilst still attached to the mask frame 11),
the inner assembly and the outer assembly releasably connectable through the vent to form the mask fluid flow passage through the vent (Column 3, lines 4-7, Resilient detents 42 on the elbow 26 pass through and engage behind slot-forming formations 44 in the vent/connector piece 28 to provide releasable engagement of the two parts), (Column 3, lines 22-26, the anti-asphyxia valve arrangement cannot be disassembled without first removing the elbow and vent/connector piece assembly from the mask. However, once disconnected from the mask, the assembly may be readily separated for cleaning and then reassembled)
It would have been obvious to one skilled in the art before the effective filing date to incorporate the art-recognized sealing means taught by Gunaratnam with the overall mask structure taught by Hely. Hely teaches a variety of applicable interfaces for the device (Pages 5-6, lines 29-3, The mask shown is just an example of numerous types of breathing-patient interfaces. Although the present invention's valve can be used for any type of closed air delivery system, it is preferably used in CPAP applications), and thus the sealing arrangement could be adjusted based on the specific mask structure.
Regarding Claim 5, Hely discloses all of the limitations of Claim 3. Hely further discloses: wherein the mask connector member includes a first mechanical coupling element and the hose connector member includes a second mechanical coupling element the first and second mechanical coupling elements configured to releaseably couple the hose connector member to the mask connector member (Figure 5, Page 10, lines 12-15, The valve of the present invention is also very easily cleaned, and may be disassembled, cleaned and reassembled very easily at home or at a hospital or clinic) (Page 9, lines 6-10, Figures 12 and 13 are exploded perspective views illustrating the preferred embodiment of the valve of the present invention. As can be seen, the elements are easily moulded components preferably out of an engineered polymer or thermoplastic. It is important to note that the valve can be easily taken apart and thereafter easily reassembled)
Regarding Claim 6, Hely discloses all of the limitations of Claim 2. Hely further discloses: wherein the hose fluid flow passage is a non-linear passage (Figure 15, Page 6, lines 9-15, The location of the valve 14 shown in Figure 1 is just one example of a location under this invention. Valve 14 could be connected to mask 16, or it could be an integral part of mask 16, as shown in figures 14 and 15. It also could be located at the outlet of the flow generator 10)
Regarding Claim 8, Hely discloses all of the limitations of Claim 1. Hely further wherein the biasing member is a compression spring (Page 7, lines 9-16, Generally, this will be referred to as the returning force which acts to close the slider valve 24 in the event of decreased air flow. This returning force means can be any type of force which imparts a force on the slider valve 24 to close in the event that airflow is terminated or diminished. A preferred force is a magnetic force, but in other embodiments (not shown) springs, electro magnetic pulses, elastic materials, gravity, or other biasing forces are non-limiting examples of other types of forces are used. These are merely examples of biasing forces, other structural mechanisms are also used to close the slider valve 24 in the event that airflow is terminated or slowed to the extent that not enough air is delivered to the patient).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Hely (WO 9826830 A1) in view of Cragg et al. (US 10272226 B2, hereinafter “Cragg”), further in view of Ho et al. (US 20080078395 A1, hereinafter “Ho”)
Regarding Claim 7, Hely discloses all of the limitations of Claim 2. However, Hely does not disclose wherein the mask valve is a disc valve
Cragg does disclose wherein the mask valve is a disc valve (Column 18 ,lines 16-21, According to various embodiments, valves may be any of a number of different types of valves, such as but not limited to flap valves, hinge-less valves, balloon valves, stepper valves, ball valves, shape memory flap valves, membrane valves, iris valves, flute valves, slit valves or the like), (Column 20, lines 17-20, one embodiment of an expiratory valve 40 may be a disc valve made of a flexible material)
Ho also discloses (Paragraph 0042, A sealing member 16 (such as, without limitation, an umbrella valve, a diaphragm valve, a butterfly valve, a duck-bill valve, a cone valve, a spiral valve, and a bi-leaflet valve) is structured to control flow of positive pressure gas 18 through inner ports 12)
It would have been obvious to one skilled in the art before the effective filing date to incorporate the art-recognized valve alternatives taught in other connector apparatus designs, such as the ones presented by Cragg or Ho. It would have been an obvious modification, as the alternative valve arrangements would serve the same purpose of providing a controllable means of regulating air flow to a user, and would not impede on the functionality of Hely’s connector apparatus.
Claim 1 is rejected under 35 U.S.C. 102(a)(2) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Ho (US 20080078395 A1)
Regarding Claim 1, Ho discloses: A connector apparatus (Paragraph 0038, FIGS. 2-11, 20, and 21 illustrate various embodiments of a pressure reducing valve for use with a system adapted to provide a regimen of respiratory therapy to a patient, such as and without limitation, system 100), comprising:
a mask connector member (Paragraph 0040, Pressure reducing valve 1 includes a valve body 2 and an inner sleeve 10) to be secured to a mask to govern fluid flow through a vent in the mask (Paragraph 0037, Any type of patient interface device 105, however, which facilitates the delivery of the flow of breathing gas communicated from pressure generating device 103 to the airway of patient 101 may be used while remaining within the scope of the present invention. As shown in FIG. 1, patient interface 105 is coupled directly with pressure reducing valve 1; other arrangements, however, are contemplated), the mask connector member forming a mask fluid flow passage through the vent between an external inlet and an internal outlet (Paragraph 0038, In each embodiment, the pressure reducing valve is structured to isolate the patient's airway from the flow of breathing gas by "dumping" the flow of breathing gas to atmosphere during the expiratory phase. The pressure reducing valve is also structured to dump a flow of exhalation gas to atmosphere with minimal or no mixing of the flow of breathing gas and the flow of exhalation gas)
the mask connector member including a mask valve received in the mask fluid flow passage (Paragraph 0040, Patient interface end 6 is structured to deliver the flow of positive pressure gas 18 to the airway of a patient and/or to receive a flow of exhalation gas (as indicated by arrow 20, for example, in FIG. 3) from the airway of the patient), the mask valve movable between
a rest position in which the mask fluid flow passage is blocked by the mask valve (Paragraph 0046, As employed herein, pressure reducing valve 1 is said to be "closed" or in a "closed position" when inner ports 12 are substantially closed (i.e., when sealing member 16 substantially occludes inner ports 12) and pressurized gas exhaust ports 8a and exhalation gas exhaust ports 8b are substantially closed (i.e., when inner sleeve 10 substantially occludes exhaust ports 8a and 8b)) and
an actuated position in which the mask fluid flow passage is unblocked by the mask valve (Paragraph 0044, As employed herein, pressure reducing valve 1 is said to be "open" or in an "open position" when inner ports 12 are substantially open (i.e., when sealing member 16 does not substantially occlude inner ports 12) and pressurized gas exhaust ports 8a and exhalation gas exhaust ports 8b are substantially open (i.e., when inner sleeve 10 does not substantially occlude exhaust ports 8a and 8b))
the mask connector member further including a biasing member (Figure 20, biasing member 17) biasing the mask valve towards the rest position to block a fluid flow (Paragraph 0052, it is contemplated that the biasing members may be structured to cause the inner sleeve to return to the open position) from a fluid hose through the mask fluid flow passage (Paragraph 0051, FIGS. 20-21, for example, show pressure reducing valve 1'''' employing magnets (17a, 17b) as the biasing member 17. When flow of positive pressure gas 18 is absent, attraction between magnets 17a and magnets 17b causes inner sleeve 10'' to return to the closed position (FIG. 21). It is contemplated that the location and/or polarity of magnets 17a and/or 17b may altered such that magnets 17a and magnets 17b repel each other to cause inner sleeve 10'' to return to the closed position);
and a hose connector member to be secured to the fluid hose the hose connector member (Paragraph 0040, Pressure generator end 4 is structured to receive a flow of positive pressure gas (i.e., breathing gas; indicated by arrow 18, for example, in FIG. 2) from a pressure generating device), (Paragraph 0042, Inner sleeve 10 is received within valve body 2 and is movable therein (for example, between first stop ring 7a and second stop ring 7b) forming a hose fluid flow passage between a hose inlet and a mask outlet (Paragraph 0036, Patient circuit 102 is structured to communicate the flow of breathing gas from pressure generating device 103 to patient interface device 105)
the hose inlet shaped to receive the fluid flow from the fluid hose when the fluid hose is secured to the hose connector member (Paragraph 0040, For example, pressure generator end 4 is adapted to couple with one end of conduit 104 (FIG. 1); the other end of conduit 104 is adapted to couple with pressure generating device 103), (Paragraph 0045, Referring to FIG. 2, the radial surface at the end of inner sleeve 10 nearest pressure generator end 4 may be referred to as a "pressure generator impingement face" 10a […] Flow of positive pressure gas 18 exerts a force on pressure generator impingement face 10a causing inner sleeve 10 to move within valve body 2)
the mask outlet shaped to form a sealed connection with the external inlet of the mask connector member to supply the fluid flow to the external inlet of the mask connector member when the hose connector member is coupled to the mask connector member (Paragraph 0040, pressure generator end 4 is adapted to couple with one end of conduit 104 (FIG. 1); the other end of conduit 104 is adapted to couple with pressure generating device 103. […] patient interface end 6 is adapted to couple with patient interface device 105 (FIG. 1) which is in fluid communication with the airway of patient 101)
the hose connector member including a valve actuator to move the mask valve to the actuated position when the hose connector member is coupled to the mask connector member to unblock the fluid flow through the mask fluid flow passage for supplying the fluid flow from the fluid hose to the vent in the mask (Paragraph 0051, It is contemplated that the location and/or polarity of magnets 17a and/or 17b may altered such that magnets 17a and magnets 17b repel each other to cause inner sleeve 10'' to return to the closed position)
Response to Arguments
Applicant’s arguments with respect to the 103 rejection of Claim 1 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
The Applicant has amended Claim 1 to include the following new limitations:
“the mask connector member further including a biasing member biasing the mask valve towards the rest position to block fluid flow from a fluid hose through the mask fluid flow passage” and
“the hose connector member is coupled to the mask connector member to unblock fluid flow through the mask fluid flow passage for supplying the fluid flow from the fluid hose to the vent in the mask”
Based on the amended claim language, the prior art rejection for Claim 1 has been updated accordingly. Please refer to Claim 1 above for further explanation. Additional relevant art is listed below in the Conclusion.
Allowable Subject Matter
Claim 4 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims. The following is a statement of reasons for the indication of allowable subject matter:
The following limitation is the primary reason for allowance:
wherein the second magnetic element is secured to a hose valve,
the hose valve received in the hose fluid flow passage and movable between a rest position in which the hose fluid flow passage is blocked by the hose valve and an actuated position in which the hose fluid flow passage is unblocked by the hose valve,
the hose valve configured to be drawn toward the actuated position when adjacent the mask valve by the first magnetic element
Regarding Claim 4, Hely discloses all of the limitations of Claim 3. However, Hely does not disclose an embodiment of the connection apparatus that further includes a “hose valve” that is actuated through the “second magnetic element” (Figure 5, magnet 38) being drawn toward the “first magnetic element” (Figure 5, magnet 36). Likewise, Ho also does not disclose magnetic elements (Figure 20, magnets 17a, 17b) “secured to a hose valve”
Cragg discloses an optional inspiration or expiration valve incorporated in the air flow tubing (Column 4, lines 12-24, a one-way, variable resistance expiratory valve coupled with the mask or the tube to allow exhaled air to exit the mask during exhalation […] Optionally, the system may further include an inspiration valve in the mask or the tube that opens during inspiration to allow outside air to enter the mask). Cragg further describes “magnetic elements” within the valve that serve as actuators (Column 29, lines 45-57, As mentioned above, the various embodiments of variable resistance, one-way, expiratory valves described in this application may generally be driven (or actuated) in one of two different ways … In other embodiments, expiratory valves may be driven by mechanical or electromechanical means), (Column 29, lines 1-6, one of rods 174 may be coupled with a stationary support member, and the other rod 174 may be free to move. In addition, rods 174 may have facing ends that either oppose or attract one another, according to various embodiments, and may be forced to move in one way or another, based on whether they tend to oppose or attract).
However, it would not be an obvious modification to incorporate this valve structure into the connector apparatus disclosed by Hely or Ho, as there is no teaching of the hose valve being attached to the biasing member in order to concurrently actuate a separate mask valve.
None of the prior art of record (applied individually or in combination) teaches “the hose valve configured to be drawn toward the actuated position when adjacent the mask valve by the first magnetic element”, nor does the prior art render said limitation obvious.
Any comments considered necessary by applicant must be submitted no later than the payment
of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Hallett et al. (US 10272223 B2) disclose a pressure responsive respiratory valve apparatus with multiple internal valve locations
Holyoake et al. (US 10716912 B2) discloses a respiratory interface that incorporates a valve mechanism within a gas supply tube
Kim (KR 100828132 B1) discloses a respiratory mask that incorporates magnetic valve biasing elements
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MISHAL ZAHRA HUSSAIN whose telephone number is (703)756-1206. The examiner can normally be reached M-F, 8:30am - 5:00pm.
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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 ZAHRA HUSSAIN/
Examiner
Art Unit 3785
/BRANDY S LEE/Supervisory Patent Examiner, Art Unit 3785