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
This action is responsive to the amendment filed 11/10/2025. Claims 31 and 35 have been canceled and claims 36-37 added. Thus claims 1-2, 4, 6-30, 34 and 36-37 are pending.
Claim Interpretation
Regarding claim 1, the limitations of a “nasal respiratory mask” and a “nasal breathing cavity” are seen to call to masks and spaces that include a user’s nose and optionally include a user’s mouth. Although the term “nasal mask” typically refers to masks that cover only a user’s nose and leave a mouth unobstructed, dependent claims 13 and 15 along with applicant’s disclosure suggest that the mask of the instant application may also cover a user’s mouth.
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 1-2, 4, 6-10, 12-15, 19-20, 23-24, 27-30 and 36-37 are rejected under 35 U.S.C. 103 as being unpatentable over Henry (US 2016/0296720 A1) in view of Cragg (US 2013/0312757 A1) and Foley (US 5645049 A).
Regarding claim 1, Henry discloses a nasal respiratory mask for a high flow oxygen therapy apparatus (3000 fig 1b, par 0952 discloses supplying oxygen, par 0945 discloses supply at 120 liters/minute thus disclosing high flow), comprising: a mask frame (3310 fig 30-37 and 3200 fig 34, par 0525); and a mask cushion (3100 fig 34, par 0458) on the mask frame for contacting and substantially sealing against a face of a user (par 0458, 0525 “seal forming structure”, par 0483), the mask frame and mask cushion defining a nasal breathing cavity (internal area of the cushion and mask frame, par 0483 “sealed path for breathable gas”), wherein the mask frame comprises: a hose attachment portion (3600 fig 33) for attaching a hose for delivering a supply of oxygen enriched air to the user (par 0455); and two vents (3400 fig 30-34, par 0525).
Henry is silent to two passive one-way valves, each one-way valve being configured to move from a closed position in which air is restricted from flowing through the one-way valve, to an open position in which air can flow from the nasal breathing cavity through the one- way valve to outside the mask, wherein each of the one-way valve has a valve opening pressure of between 0.2 kPa and 1 kPa, instead disclosing two vents (#3400 fig 30-34, par 0525) for exhausting air (par 0832 “arranged to allow for washout of exhaled air”, par 00834) and maintaining an internal mask pressure (par 0854).
Cragg teaches a respiratory mask with a passive one-way valve (#28 fig 3A, 4A-4B, 4D-4E, par 0086 “expiration valve 28”) configured to move from a closed position in which air is restricted from flowing through the one-way valve, to an open position in which air can flow from the nasal breathing cavity through the one-way valve to outside the mask (par 0086 discloses an expiration valve thus disclosing a one way valve where the open position allows air to pass to the outside of the mask), wherein the one-way valve has a valve opening pressure of between 0.2 kPa and 1 kPa (par 0019 discloses the expiration valve having an opening pressure of preferably 2-5 cm H2O equal to about 0.2-0.5kPa) each one-way valve including: an aperture (see aperture covered by 28 in fig 5A-5B); a diaphragm that sits over the aperture (#28 fig 5a-5B), the diaphragm being moveable between a closed position (see fig 5B) in which the diaphragm prevents air passing through the aperture from outside the mask to inside the nasal breathing cavity and an open position (see fig 5A) in which air may move through the aperture to outside the mask.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to replace the washout/expiration vents of Henry with passive one-way expiration valves as taught by Cragg as doing so prevents outside air from entering the mask thereby preserving the oxygen concentration delivered to the patient.
Modified Henry remains silent to each of the one-way valves further including a stem connected to the diaphragm, the stem extending through the mask frame.
Foley teaches a face mask with a one way exhalation valve (#60 fig 1-2, 4-5, 7-8), the valve including an aperture (#58 fig 2-5); a diaphragm that sits over the aperture (#62 fig 4-8), the diaphragm being moveable between a closed position (see full line position in fig 4) in which the diaphragm prevents air passing through the aperture from outside the mask to inside the nasal breathing cavity and an open position (see dotted line position in fig 4, col 4 ln 15-19) in which air may move through the aperture to outside the mask and a stem (#68 fig 4, 7) connected to the diaphragm, the stem extending through the mask frame (see fig 4).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize a check valve with a stem as taught by Foley, as the structure is common for check valves and will thus reduce manufacturing costs.
Regarding claim 2, modified Henry discloses the mask of claim 1. Cragg further discloses the valve opening pressure is less than 0.8 kPa (par 0019 preferably 2-5 cm H2O equal to about 0.2-0.5kPa).
Regarding claim 4, modified Henry discloses the mask of claim 1. Modified Henry further discloses a flow rate through the one-way valve in the open position is configured to be at least 2 litres per minute (Henry: par 0854 discloses a flow rate of 47-53 litres per minute through the vent, Cragg: par 0018 discloses the valve as having variable resistance, thus the valve of Cragg is capable of a flow rate as disclosed/intended by Henry).
Regarding claim 6, modified Henry discloses the mask of claim 1. Cragg further discloses the one-way valve is a flapper valve or a lift-check valve (par 0098 “flap valves”).
Regarding claim 7, modified Henry discloses the mask of claim 1. Henry further discloses the mask frame has a generally domed shape (see fig 1b).
Regarding claim 8, modified Henry discloses the mask of claim 1. Henry further discloses the mask cushion comprises a thermoplastic elastomer and/or silicone (par 0459).
Regarding claim 9, modified Henry discloses the mask of claim 1. Henry further discloses the mask cushion and at least a perimeter of the mask frame are integrally formed of the same material (see fig 34 showing the cushion 3100 and the perimeter of the mask frame 3200 being integrally formed, see also par 0079 disclosing the cushion and mask frame both being made of silicon).
Regarding claim 10, modified Henry discloses the mask of claim 1. Henry further discloses at least a portion of the mask frame comprises a substantially less flexible material than the material of the mask cushion (par 0079).
Regarding claim 12, modified Henry discloses the mask of claim 1. Henry further discloses the hose attachment portion is substantially centrally located on a vertical centre line of the mask frame (see fig 32).
Regarding claim 13, modified Henry discloses the mask of claim 1. Henry is silent to the hose attachment portion is located towards a lower end of the mask frame, as to be adjacent a middle of a user’s mouth when worn.
Cragg teaches a hose attachment portion located towards a lower end of the mask frame (see 12a fig 2, and 32 fig 4a, 4b, 4e ) as to be adjacent a middle of a user’s mouth when worn (fig 2 #12a,b,c showing the lower end of the mask adjacent to a middle of a user’s mouth.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the mask of Henry to extend to cover a user’s mouth and have the hose attachment located at the lower mouth end of the mask as taught by Cragg as doing so allows for a user to inhale the oxygen enriched air through their mouth as well as their nose.
Regarding claim 14, modified Henry discloses the mask of claim 1. Modified Henry further discloses the two passive one-way valves spaced substantially symmetrically about a vertical centre line of the mask frame (Henry: fig 32, par 0061 discloses two vents on either side of the centre line, with modification of Cragg there are two valves one on either side).
Regarding claim 15, modified Henry discloses the mask of claim 1. Henry is silent to the two one-way valves are located towards a lower end of the mask frame so as to be adjacent either side of a user's mouth when worn.
Cragg additionally teaches two or more valves located towards a lower end of the mask frame so as to be adjacent either side of a user's mouth when worn (see 28/30 fig 4a-b, 4d-e).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the mask of Henry to extend to cover a user’s mouth and have the vents located at either side of a user’s mouth as taught by Cragg as doing so allows for a user to exhale through their mouth directly to the outlet vents, better expelling air exhaled through the mouth.
Regarding claim 19, modified Henry discloses the mask of claim 1. Henry further discloses the hose attachment portion comprises a swivel connector configured to provide relative rotation between the mask frame and the hose (par 0871 "it may also be possible to form the connection port 3600 separately from the frame 3310 and connect these components such that the connection port 3600 may rotate relative to the frame 3310 using a swivel connection").
Regarding claim 20, modified Henry discloses the mask of claim 1. Henry further discloses a pair of opposing straps and/or harness extending from the mask frame (3300 fig 30-34, par 0525).
Regarding claim 23, modified Henry discloses the mask of claim 1. Modified Henry further discloses a filter membrane arranged to cover the one-way valve (Henry: par 0842 discloses a porous element on the vent, par 0834 discloses the porous region as providing a tortuous airpath thus the element is seen as a filter membrane, with modifications of Cragg the porous membrane would be on the valve).
Regarding claim 24, Henry discloses a nasal respiratory mask system comprising the nasal respiratory mask of claim 1 (see claim 1 above, with modification of Cragg) and a hose (4180 fig 30-34) for attaching to the hose attachment portion of the nasal respiratory mask for delivering a supply of oxygen enriched air to the user (par 0511 discloses connecting the hose to a pap device, 0952 discloses supplying oxygen).
Regarding claim 27, modified Henry discloses the system of claim 24. Henry further discloses the hose is malleable and/or comprises a malleable member, such that the hose is configured to be deformable and retain a given shape when the hose is manipulated (see par 0897-0899 disclosing flexibility of the tube due to coiling/corrugation).
Regarding claim 28, Henry discloses A high flow oxygen therapy apparatus comprising: the nasal respiratory mask system of claim 24 (see claim 24 above, with modification of Cragg from claim 1); and an oxygen enriched air supply coupled via the hose to the respiratory mask and configured to supply oxygen enriched air to a user (par 0952 discloses supplying oxygen, par 0511 connected to the pap device via hose).
Regarding claim 29, modified Henry discloses the apparatus of claim 28. Henry further discloses the oxygen enriched air supply is configured to deliver a flow rate of at least 5 litres per minute to the user (par 0945 discloses supply at 120 liters/minute).
Regarding claim 30, modified Henry discloses the mask of claim 28. Henry is silent to the oxygen enriched air supply is configured to deliver a flow rate of less than 70 litres per minute to the user.
Cragg teaches a respiratory mask where an air supply is configured to deliver a flow rate of less than 70 litres per minute to the user (par 0024).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Henry to deliver a lower flow rate as taught by Cragg as extremely high flow rates can be uncomfortable for the user (Cragg par 0007).
Regarding claim 36, modified Henry discloses the mask of claim 1. Foley further discloses the diaphragm is configured to have a curved shape in the open position that allows air to pass through the aperture from the nasal breathing cavity to outside the mask (see dotted line position in fig 4, col 4 ln 15-19).
Regarding claim 36, modified Henry discloses the mask of claim 1. Foley further discloses the stem comprises an outward projection disposed in the nasal breathing cavity for securing the one-way valve (#72 fig 4, 7).
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over modified Henry as applied to claim 1 above, and further in view of Jones (US 2004/0211427 A1).
Regarding claim 11, Henry discloses the mask of claim 1. Henry is silent to the mask cushion is inflatable and deflatable.
Jones discloses a respiratory mask with a mask cushion that is inflatable and deflatable (par 0009).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize an inflatable and deflatable cushion as taught by Jones for the cushion of Henry as doing so allows for the cushion to be customized for patient comfort and preventing air leakage (Jones par 0009).
Claims 16-18 and 25-26 are rejected under 35 U.S.C. 103 as being unpatentable over modified Henry as applied to claims 1 and 24 above, and further in view of Hurmez (US 20130098360 A1).
Regarding claim 16, modified Henry discloses the mask of claim 1. Henry is silent to the mask frame is at least partially formed from a water permeable material.
Hurmez teaches a respiratory system in which a mask frame is at least partially formed from a water permeable material (par 0020).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have the mask component of the Henry be made of a water vapor permeable material as taught by Hurmez as doing so prevents condensation build up on the component impacting pressure maintenance and the systems the mask is connected to (Hurmez par 0007).
Regarding claim 17, modified Henry discloses the mask of claim 16. Modified Henry further discloses at least 50% of the mask frame is formed from the water permeable material (as Henry discloses constructing the entire mask of water permeable material , see par 0020, it is seen that at least 50% of the mask frame is formed of the material upon modification).
Regarding claim 18, modified Henry discloses the mask of claim 16. Modified Henry further discloses the water permeable material is permeable to liquid water and/or water vapour (par 0020 water vapor permeable).
Regarding claim 25, modified Henry discloses the system of claim 24. Henry is silent to the hose comprises a water permeable material.
Hurmez teaches a respiratory system in which a hose comprises a water permeable material (par 0020).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have the hose of the Henry be made of a water vapor permeable material as taught by Hurmez as doing so prevents condensation build up on the component impacting the systems the hose is connected to (Hurmez par 0007).
Regarding claim 26, modified Henry discloses the system of claim 25. Modified Henry further discloses the water permeable material is permeable to liquid water and/or water vapour (par 0020 water vapor permeable).
Claims 21-22 are rejected under 35 U.S.C. 103 as being unpatentable over modified Henry as applied to claim 1 above, and further in view of Lehman (US 8,365,734 B1).
Regarding claim 21, modified Henry discloses the mask of claim 1. Henry discloses a carbon dioxide sensor (par 0962); however, Henry does not expressly disclose a carbon dioxide monitoring line connector on the mask frame for attaching a carbon dioxide monitoring line and/or a carbon dioxide sensor.
Lehman teaches a respiratory mask with a carbon dioxide monitoring line connector (31 fig 1-2, col 5 ln 44-46) on the mask frame for attaching a carbon dioxide monitoring line (32 fig 5-4, col 5 ln 44-46) and/or a carbon dioxide sensor (col 5 ln 44-46 “carbon dioxide monitor (such as a capnograph)”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the carbon dioxide monitoring line system of Lehman onto the mask of Henry as capnographs with monitoring lines are common in the art thus making the mask compatible with existing carbon dioxide monitoring systems.
Regarding claim 22, modified Henry discloses the mask of claim 21. Modified Henry further discloses a carbon dioxide monitoring line (Lehman 32 fig 5-4, col 5 ln 44-46) attached to the carbon dioxide monitoring line connector and a carbon dioxide sensor attached to the carbon dioxide monitoring line (col 5 ln 44-46).
Claim 34 is rejected under 35 U.S.C. 103 as being unpatentable over modified Henry as applied to claim 1 above, and further in view of Dantanarayana (US 2018/0264222 A1).
Regarding claim 34, modified Henry discloses the mask of claim 1. Modified Henry further discloses a connector for attaching the hose, the connector being connected to the hose attachment portion (par 0870-0871).
Modified Henry is silent to the connector for attaching the hose being a one-way snap-fit connection.
Dantanarayana teaches a connector for attaching the hose (#9110 fig 7A, par 0439), the connector being connected to the hose attachment portion by a one-way snap-fit connection (par 0439 “the conduit connector 9110 and the vent housing 9120 may comprise a snap-fit, may be permanent such that the connection cannot be separated without damaging at least one of the components” the disclosure of the snap-fit connection being permanent is seen as disclosing a one-way snap fit connection).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize a one-way snap-fit connection for the hose connection as taught by Dantanarayana on the device of modified Henry as doing so allows for the connection of the hose to the patient interface to be permanently secured thus preventing disconnection of the air supply from the patient.
Response to Arguments
Applicant’s arguments with respect to 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.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
GB 696,769 discloses a respiratory device valve that allows for the outlet valve opening to be adjusted in size
CN 112957586 A discloses a respiratory mask with a valve adjustment member (see fig 4-5)
Rapoport US 5,065,756 discloses a respiratory system with a vented mask
Drew US 6,581,594 B1 discloses a mask with a washout vent having a bubble point of 2 kPa
Lepel US 2007/0049841 A1 discloses a peep valve having an opening pressure of 0.5kPA
Terry US 2008/0027344 A1 discloses tubing permeable to water vapor
Cragg US 2013/0312757 A1 discloses an expiration/peep valve with an opening pressure of 0-1.5 kPa
Bowditch US 2014/0144445 A1 discloses a nasal mask with relief valves for 0.8, 0.9, 1kPa pressures
McCarthy US 2017/0143932 A1 discloses a mask with an inflatable cushion and a lever or knob for valve adjustment
Robitaille US 10,314,991 B2 discloses a valve adjustment mechanism to adjust the opening pressure
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 KIRA B DAHER whose telephone number is (571)270-0190. The examiner can normally be reached M-F 8am-5pm.
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 Lee can be reached on (571) 270-7410. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/K.B.D./Examiner, Art Unit 3785
/BRADLEY H PHILIPS/Primary Examiner, Art Unit 3799