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 .
Election/Restrictions
This action is responsive to the election filed 12/19/2025. Applicant withdraws claims 1-14, 18-23, 27-30 and 32-33 without traverse, thus claims 15-17, 24-26, 31 and 34-57 are addressed below.
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.
Claims 17, 49, 50 and 56 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.
Regarding claims 17 and 56, the phrase "preferably" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Regarding claims 49-50, the phrase "optionally" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
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, 24-26, 31, 34, 38-42, 46-47, 51 and 54-57 are rejected under 35 U.S.C. 103 as being unpatentable over Cragg (US 2014/0246025 A1) in view of Jones (US 2004/0211427 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 heated, humidified oxygen enriched air to the patient (par 0232 discloses oxygen, par 0026 discloses variable flow rate, par 0232 discloses monitoring temperature and humidity of delivered flow thus disclosing heated and humidified), 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 heated, humidified 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).
Jones discloses a nasal mask with an inflatable cushion for the face contacting member (abstract, par 0009, 0051, #12 fig 1-2).
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 cushion for the mask of Cragg as taught by Jones as doing so allows for the mask seal to be customized for the user through inflation and deflation (Jones: par 0009).
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, preferably 0.3 to 0.7 kPa (par 0018 2-5 cm water is about 0.2-0.5 kPa), preferably 0.4 to 0.6 kPa (par 0018 5 cm water is about 0.5 kPa).
Regarding claim 24, Cragg discloses a nasal respiratory mask (#22 fig 3a, 4a-4e, par 0153) for a high flow oxygen therapy apparatus (Par 0232 discloses oxygen delivery, par 0034 discloses both low and higher flow rates, par 0054 discloses 50 L/min), comprising: a mask frame (main body of #22); a mask contact portion (#38 fig 4a, 4e, par 0160) on the mask frame for contacting and substantially sealing against a face of a patient (par 0160), the mask frame and mask cushion defining a nasal breathing cavity (interior of mask 22, visible in fig 4a); the mask frame having: a hose attachment portion (#32 fig 4a-4e, par 0152) for attaching a hose for delivering a supply of oxygen enriched air to the patient; and a mask aperture having 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 outside the mask (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 valve opening pressure for maintaining 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).
Jones discloses a nasal mask with an inflatable cushion for the face contacting member (abstract, par 0009, 0051, #12 fig 1-2).
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 cushion for the mask of Cragg as taught by Jones as doing so allows for the mask seal to be customized for the user through inflation and deflation (Jones: par 0009).
Regarding claim 25, modified Cragg discloses the mask of claim 24. Cragg further discloses the one-way valve is a biased one-way valve (par 0460 disclosing biasing the expiratory valve) having a valve opening pressure of less than 1 kPa or less than 0.8 kPa and/or wherein the valve opening pressure is greater than 0.2 kPa (par 0018 discloses 2-5 cm water opening pressure, about 0.2-0.5kPa).
Regarding claim 26, modified Cragg discloses the mask of claim 25. Cragg further discloses the one-way valve is a flapper valve or a lift-check valve (par 0164 “flap valve”).
Regarding claim 31, modified Cragg discloses the mask of claim 24. Cragg further discloses the one-way valve is a flapper valve or a lift-check valve (par 0164 “flap valve”).
Regarding claim 34, modified Cragg discloses the mask of claim 24. Cragg further discloses the mask frame has a generally domed shape (see fig 4b, 4e).
Regarding claim 38, modified Cragg discloses the mask of claim 24. Jones further discloses the mask cushion is inflatable and deflatable (abstract, par 0009).
Regarding claim 39, modified Cragg discloses the mask of claim 24. Cragg further discloses the hose attachment portion is substantially centrally located on a vertical centre line of the mask frame (see fig 4a-4e).
Regarding claim 40, modified Cragg discloses the mask of claim 24. Cragg further discloses the hose attachment portion is located towards a lower end of the mask frame, preferably so as to be adjacent a middle of a user's mouth when worn (see fig 4a-4e).
Regarding claim 41, modified Cragg discloses the mask of claim 24. Cragg further discloses two of the mask apertures spaced substantially symmetrically about a vertical centre line of the mask frame (see aperture for expiratory valve 28 and aperture for valve 30 fig 3a).
Regarding claim 42, modified Cragg discloses the mask of claim 41. Cragg further discloses the two mask apertures are located towards a lower end of the mask frame so as to be adjacent either side of a user's mouth when worn (see fig 3a, 4a-4b, 4d).
Regarding claim 46, modified Cragg discloses the mask of claim 24. Jones further teaches the hose attachment portion comprises a swivel connector configured to provide relative rotation between the mask frame and the hose (par 0045).
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 swivel connector as taught by Henry on the mask of modified Cragg as doing so allows for the hose to adjust position relative to the mask as the user moves their head, thus preventing disconnection or breakage in the hose.
Regarding claim 47, modified Cragg discloses the mask of claim 24. Cragg further discloses a pair of opposing straps and/or harness extending from the mask frame (par 0153).
Regarding claim 51, modified Cragg discloses a nasal respiratory mask system comprising the nasal respiratory mask of claim 24 (see claim 24 above) and a hose (Cragg: #26 fig 3a, #146 fig 3b, #156 fig 3c) for attaching to the hose attachment portion of the nasal respiratory mask for delivering a supply of oxygen enriched air to the user (par 0152).
Regarding claim 54, modified Cragg discloses the mask system of claim 51. Cragg 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 (par 0157 discloses a flexible tube, fig 3b-3c disclose a corrugated tubing thus disclosing the hose to be deformable and retaining a given shape).
Regarding claim 55, modified Cragg discloses a high flow oxygen therapy apparatus comprising: the nasal respiratory mask system of claim 51 (see claim 51 above); 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 0232 discloses oxygen delivery).
Regarding claim 56, modified Cragg discloses the apparatus of claim 55. Cragg further discloses the oxygen enriched air supply is configured to deliver a flow rate of at least 5 litres per minute to the user, and preferably a flow rate of between 30 and 60 litres per minute (par 0054 discloses 50 L/min).
Regarding claim 57, modified Cragg discloses the apparatus of claim 55. Cragg further discloses the oxygen enriched air supply is configured to deliver a flow rate of less than 70 litres per minute to the user (par 0054 discloses 50 L/min).
Claims 35-37 are rejected under 35 U.S.C. 103 as being unpatentable over modified Cragg as applied to claim 24 above, and further in view of Henry (US 2016/0296720 A1).
Regarding claim 35, modified Cragg discloses the mask of claim 24. Modified Cragg is silent to the mask cushion comprises a thermoplastic elastomer and/or silicone.
Henry discloses a nasal mask (#3310 fig 30-37 and #3200 fig 34) and a mask cushion (#3100 fig 34) where the mask cushion comprises a thermoplastic elastomer and/or silicone (par 0459).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize silicone for the cushion of Cragg as taught by Henry as doing so provides a soft and resilient material for the seal (Henry: par 0459).
Regarding claim 36, modified Cragg discloses the mask of claim 24. Modified Cragg is silent to the mask cushion and at least a perimeter of the mask frame are integrally formed of the same material.
Henry discloses a nasal mask (#3310 fig 30-37 and #3200 fig 34) and a mask cushion (#3100 fig 34) where the mask cushion and at least a perimeter of the mask frame are integrally formed of the same material (par 0079 disclosing the cushion and mask both being made of silicone, see also fig 34 showing the mask frame and cushion being integral).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize silicone for the cushion and mask of Cragg as taught by Henry as doing so provides a soft and resilient material for the mask (Henry: par 0459).
Regarding claim 37, modified Cragg discloses the mask of claim 24. Modified Cragg is silent to at least a portion of the mask frame comprises a substantially less flexible material than the material of the mask cushion.
Henry discloses a nasal mask (#3310 fig 30-37 and #3200 fig 34) and a mask cushion (#3100 fig 34) where at least a portion of the mask frame comprises a substantially less flexible material than the material of the mask cushion. (par 0079).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize silicone for the cushion and mask of Cragg as taught by Henry as doing so provides a soft and resilient material for the seal integrally formed to the mask preventing breakage (Henry: par 0459, 0079).
Claims 43-45 and 52-53 is/are rejected under 35 U.S.C. 103 as being unpatentable over modified Cragg as applied to claims 24 and 51 above, and further in view of Hurmez (US 2013/0098360 A1).
Regarding claim 43, modified Cragg discloses the mask of claim 24. Modified Cragg 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 utilize a water permeable material as taught by Hurmez for the mask frame of modified Cragg as doing so prevents condensation build up on the components impacting pressure maintenance and the system the mask is connected to (Hurmez: par 0007).
Regarding claim 44, modified Cragg discloses the mask of claim 43. Hurmez further discloses at least 50% of the mask frame is formed from the water permeable material (as Hurmez par 0020 discloses forming the water permeable material into a mask it is seen that the entire mask frame is formed of the material thus at least 50% is formed of the material).
Regarding claim 45, modified Cragg discloses the mask of claim 43. Hurmez further discloses the water permeable material is permeable to liquid water and/or water vapour (par 0020 “water vapor permeable”).
Regarding claim 52, modified Cragg discloses the system of claim 51. Modified Cragg 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 utilize a water permeable material as taught by Hurmez for the hose of modified Cragg as doing so prevents condensation build up on the component impacting the system the hose is connected to (Hurmez: par 0007).
Regarding claim 53, modified Cragg discloses the system of claim 52. Hurmez further discloses the water permeable material is permeable to liquid water and/or water vapour (par 0020 “water vapor permeable”).
Claims 48 and 49 are rejected under 35 U.S.C. 103 as being unpatentable over modified Cragg as applied to claim 24 above, and further in view of Lehman (US 8,365,734 B1).
Regarding claim 48, modified Cragg discloses the mask of claim 24. Modified Cragg is silent to 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 In 44-46) on the mask frame for attaching a carbon dioxide monitoring line (#32 fig 5-4, col 5 In 44- 46) and/or a carbon dioxide sensor (col 5 In 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 modified Cragg in order to ensure that the mask is properly expelling carbon dioxide.
Regarding claim 49, modified Cragg discloses the mask of claim 48. Lehman further discloses a carbon dioxide monitoring line (#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), optionally wherein the carbon dioxide monitoring line comprises a water permeable material (due to the use of the term “optionally” this claim is seen as met without the latter limitation disclosed).
Claim 50 is rejected under 35 U.S.C. 103 as being unpatentable over modified Cragg as applied to claim 24 above, and further in view of Howe (US 2012/0012111 A1).
Regarding claim 50, modified Cragg discloses the mask of claim 24. Modified Cragg is silent to a filter membrane arranged to cover the mask aperture, optionally wherein the filter membrane is arranged to cover at least half of the mask frame, and optionally wherein the filter membrane is arranged to cover a patient's mouth.
Howe teaches a PEEP valve with an incorporated filter (abstract).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate a filter membrane as taught by Howe onto the mask aperture/one-way valve of modified Cragg as doing so prevents or reduces the passage of microbes from the patients exhalation to the atmosphere (Howe: abstract).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 24-25, 31 and 34-57 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2 and 6-30 of copending Application No. 17/505,332 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because they overlap such that infringement on the copending app would result in infringement of the instant app.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Regarding claim 24, app ‘332 discloses a nasal respiratory mask for a high flow oxygen therapy apparatus (claim 1 ln 1-2), comprising: a mask frame (claim 1 ln 3); a mask cushion on the mask frame for contacting and substantially sealing against a face of a patient (claim 1 ln 4-5), the mask frame and mask cushion defining a nasal breathing cavity (claim 1 ln 5-6); the mask frame having: a hose attachment portion for attaching a hose for delivering a supply of oxygen enriched air to the patient (claim 1 ln 7-9); and a mask aperture (claim 1 ln 20) having a passive one-way valve (claim 1 ln 10) 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 outside the mask (claim 1 ln 10-15), wherein the one-way valve has a valve opening pressure for maintaining 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 (claim 1 ln 15-17).
Claims 25, 31 and 34-57 of the instant application correspond to claims 2 and 6-30 respectively of app ‘332.
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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/KIRA B DAHER/Examiner, Art Unit 3785
/BRADLEY H PHILIPS/Primary Examiner, Art Unit 3799