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 05/08/2026. Claims 1-14, 20-26, 31 and 34-57 are now canceled. Thus claims 15-19 are pending with claims 18 and 19 withdrawn in response to restriction. The previous 112 and double patenting rejections are withdrawn in response to amendment.
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 15-17 are rejected under 35 U.S.C. 103 as being unpatentable over Cragg (US 2014/0246025 A1) in view of Smith (US 2003/0094177 A1).
Regarding claim 15, Cragg discloses a method of administering high flow oxygen therapy to a patient (Par 0232 discloses oxygen delivery, par 0034 discloses both low and higher flow rates, par 0054 discloses 50 L/min) using a high flow oxygen therapy system, the system comprising: a nasal respiratory mask (#22 fig 3a, 4a-4e, par 0153) comprising: a mask frame (main body of #22); a mask contact portion on the mask frame (#38 fig 4a, 4e, par 0160), the mask frame and mask contact portion defining a nasal breathing cavity (interior of mask 22, visible in fig 4a); a hose attachment portion (#32 fig 4a-4e, par 0152); and a mask aperture, wherein the mask aperture has a passive one-way valve (#28 fig 4a-4b, 4d-4e, par 0152) 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 directly to ambient (par 0152 “expiratory valve” thus disclosing closed position prevent flow into the mask and open allows flow out of the mask), wherein the one-way valve has a variable valve opening pressure (par 0168 "in some embodiments the opening pressure may be adjustable"); and an oxygen enriched air supply having a variable flow rate output for supplying oxygen enriched air to the patient (par 0232 discloses oxygen, par 0026 discloses variable flow rate,), the method comprising: providing the nasal respiratory mask to the patient's face so that the nasal breathing cavity surrounds the patient's nose and not the mouth (par 0162 explicitly discloses the nasal mask may cover only the nose “whether the mask covers only the nose or the nose and mouth”), and the mask contact portion contacts and substantially seals against the face of the patient (par 0160); connecting a hose (#26 fig 3a) between the hose attachment portion of the mask and the oxygen enriched air supply (par 0152); adjusting the variable flow rate output of the oxygen enriched air supply to provide a flow rate of the oxygen enriched air to the mask (par 0026, 0030 disclosing varying the flow output/commencing flow); adjusting the valve opening pressure of the mask to maintain a positive end- expiratory pressure (PEEP) in the nasal breathing cavity of between 0.2 kPa and 1 kPa during the administering of high flow oxygen therapy to the patient (par 0018 discloses 2-5 cm water opening pressure, about 0.2-0.5kPa).
Cragg is silent to the contact portion being a cushion, Cragg instead discloses an adhesive contact portion (par 0160). Cragg is further silent to the supplied air being heated and humidified, Cragg only discloses monitoring temperature and humidity of delivered flow (par 0348).
Smith discloses a similar nasal mask with a cushion for the face contacting member (#104 fig 2, par 0047) and delivering heated and humidified air (par 0043 disclosing utilizing a humidifier and heaters to treat the air that is delivered).
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 cushion for the mask of Cragg as taught by Jones as doing so allows for the mask to provide an effective seal against the patients face (Smith: par 0047). It would have further been obvious to incorporate heaters and humidifier as taught by Smith for treating the delivered air of Cragg as delivering heated and humidified air is known to minimize dryness in the patients nasal cavity and thus increase comfort.
Regarding claim 16, modified Cragg discloses the method of claim 15. Cragg further discloses the one-way valve has a variable valve opening pressure of between 0.0 kPa and 1 kPa (par 0018 discloses 2-5 cm water opening pressure, about 0.2-0.5kPa).
Regarding claim 17, modified Cragg discloses the method of claim 16. Cragg further discloses adjusting the valve opening pressure of the mask to maintain a positive end-expiratory pressure (PEEP) in the nasal breathing cavity of approximately 0.5 kPa (par 0018 5 cm water is about 0.5 kPa) during the administering of high flow oxygen therapy to the patient.
Response to Arguments
Applicant’s arguments with respect to claim 15 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.
Isaacson US 4,207,884 discloses a valve with a plunger to adjust the opening pressure between 3 and 12 cm water
Rapoport US 5,065,756 discloses a screw adjusting spring valve for adjusting opening pressure
Hoenig US 6,135,108 discloses a spring biased flapper valve adjusting between 2.5 and 20 cm water opening pressure
Bowditch US 2014/0144445 A1 discloses a cpap mask relief valve with an opening pressure adjustable by a tool utilized by a physician or user
Robitaille US 10,314,991 B2 discloses a valve with springs and adjusters for varying the opening pressure
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.
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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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/KIRA B DAHER/Examiner, Art Unit 3785
/BRADLEY H PHILIPS/Primary Examiner, Art Unit 3799
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