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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 8/11/2026 has been entered.
Response to Amendments
The Amendment filed 8/11/2026 has been entered. Claims 1 and 34-35 were amended, and claims 7-9 and 31-33 were canceled. Thus, claims 1-6, 10-30, and 34-35 are pending in the application.
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 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, 5, 11-21, 25, 27-29, and 34-35 are rejected under 35 U.S.C. 103 as being unpatentable over Harwood et al. (US 2015/0209541 A1) in view of Price et al. (US 2009/0032026 A1), Mraz (see "Fundamentals of Annular Snap-Fit Joints" article attached), and Ratner et al. (US 2016/0166794 A1).
Regarding claim 1, Harwood discloses a nasal cannula configured to deliver airflow to a user (nasal cannula for patient respiratory therapy) (abstract; para. [0072]), comprising:
a manifold (manifold 104; alternatively the manifold 104 in combination with frame 62) (Figs. 21-22; para. [0107]);
a connector for attaching a gas tube to the manifold (end of elbow 160 for connecting the supply tube 90 to the manifold 104) (Figs. 21-22; para. [0107]);
a pair of non-sealing nasal prongs extending from the manifold for delivering a supply of gas to the user via the gas tube (nasal delivery elements 82 can be prongs which do not create a complete seal with the nares of the user; nasal delivery elements 82 extend from manifold 104 to deliver air from the supply tube 90 to the user) (Figs. 21-22; para. [0080]; para. [0107]);
wherein the connector is configured to form a swivel connection with the manifold so as to provide relative rotation between the manifold and the gas tube (elbow 160 end pivots about at least one axis relative to the manifold 104/frame 62 when directly coupled to the frame 62) (Figs. 21-22; para. [0107]).
Harwood does not disclose the manifold having a ridge; the connector forming a one-way snap-fit connection with the manifold, the connector including a tapered lip having an edge that contacts the ridge to form the one-way snap-fit connection with the manifold.
However, Price teaches a mask for delivery of respiratory therapy (Price; abstract) wherein the connector forms a one-way snap-fit connection (swivel coupling 93 permanently attached to the elbow 90 with a snap-fit) (Price; Fig. 7-2; para. [0093]; para. [0097]). Moreover, Mraz teaches annular snap fits (Mraz; page 1 first paragraph) including the manifold having a ridge; the connector forming a one-way snap-fit connection with the manifold, the connector including a tapered lip having an edge that contacts the ridge to form the one-way snap-fit connection with the manifold (female hub has an internal ridge formed by an undercut groove; male plug can form a permanent connection with the female hub when the return angle is 90 degrees; the male plug has a front tapered ridge feature, and a back edge at 90 degrees that contacts the female hub internal ridge formed by the undercut groove when inserted to form the permanent connection) (Mraz; Figures on page 2; page 1 last paragraph; page 2 first five paragraphs).
Therefore, 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 Harwood manifold 104/frame 62 and elbow 160 end connector such that the connector forms a one-way snap-fit connection, as taught by Price, for the purpose of preventing separation of the parts (Price; para. [0097]). Moreover, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the modified Harwood device’s manifold 104/frame 62 and the elbow 160 end connector with the Price permanent snap fit connection, such that the manifold has a ridge; the connector forming a one-way snap-fit connection with the manifold, the connector including a tapered lip having an edge that contacts the ridge to form the one-way snap-fit connection with the manifold, as taught by Mraz, for the purpose of providing a specific suitable structure for the permanent snap-fit with which is easily joined together in the assembly (Mraz; page 1 first paragraph).
Harwood does not disclose the swivel connection being arranged to selectively hold the connector in a plurality of angular positions relative to the manifold and configured to allow the connector to be selectively retained at each of the plurality of angular positions until a predetermined degree of torque is applied to the connector.
However, Ratner teaches a patient facemask with a swivel connector (Ratner; abstract) including the swivel connection being arranged to selectively hold the connector in a plurality of angular positions relative to the manifold and configured to allow the connector to be selectively retained at each of the plurality of angular positions until a predetermined degree of torque is applied to the connector (swivel connector 10 has either the patient member 20 or the gas supply member 14 with at least one detent 22 to interface with at least one protrusion 19 on the other of the patient member 20 or the gas supply member 14; the detents 22 hold the patient member 20/gas supply member 14 in a particular position of rotation with respect to each other; the protrusions 19 interface with detents 22 to provide resistance to rotation, and thus a predetermined amount of torque would be necessary to overcome this resistance; the detents 22 and protrusions 19 allow for rotational position adjustments in increments, and so allows for a plurality of rotational positions) (Ratner; Fig. 4; para. [0030]; para. [0034]).
Therefore, 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 modified Harwood swivel connection such that the swivel connection is arranged to selectively hold the connector in a plurality of angular positions relative to the manifold and configured to allow the connector to be selectively retained at each of the plurality of angular positions until a predetermined degree of torque is applied to the connector, as taught by Ratner, for the purpose of enabling the connector to be held in a particular position of rotation with respect to the manifold after being positioned as desired, otherwise it could rotate freely out of the desired position (Ratner; para. [0030]).
Regarding claim 2, the modified Harwood teaches further comprising an elbow between the swivel connection and the gas tube (the Ratner detents 22 and protrusions 19 in the modified Harwood elbow 160 end form the swivel connection between the Harwood manifold 104/frame 62; the rest of the Harwood elbow 160 is between the Ratner detents 22/protrusions 19 and the Harwood supply tube 90) (Harwood, Figs. 21-22, para. [0107]; Ratner, Fig. 4, para. [0030], para. [0034]).
Regarding claim 5, the modified Harwood teaches wherein the swivel connection is configured to provide at least 120 degrees relative rotation (swivel connector 10 can provide up to 360 degrees of rotation) (Ratner; para. [0033]).
Regarding claim 11, the modified Harwood teaches comprising a pair of opposing straps extending from the manifold (frame 62 has opposing unlabeled arms or straps extending on either side to attach to the headgear 80) (Harwood; Figs. 21-22; para. [0089]).
Regarding claim 12, the modified Harwood teaches wherein the connector attaches to the manifold via an aperture formed in the manifold (gas supply member 14 is inserted into the patient member 20 via an aperture in the patient member 20) (Ratner; Fig. 4).
Regarding claim 13, the modified Harwood teaches wherein the aperture is located on the manifold between opposing ends of the manifold (in the modified Harwood device, the opening for the swivel elbow end connection would be centrally located between opposing ends of Harwood manifold 104) (Harwood, Figs. 21-22, para. [0107]; Ratner, Fig. 4).
Regarding claim 14, the modified Harwood teaches wherein the connector is configured to be inserted through the aperture (gas supply member 14 is inserted into the patient member 20 via an aperture in the patient member 20) (Ratner; Fig. 4).
Regarding claim 15, the modified Harwood teaches wherein the manifold comprises a face mount portion configured to be placed proximate the face of the user (Harwood manifold 104 has a portion on which the nasal delivery elements 82 sit which would be placed proximate the user’s face when in use) (Harwood; Figs. 20-22), and the aperture is on an opposite side of the manifold to the face mount portion (the opening for the elbow 160 end is on the opposite side of the manifold 104) (Harwood; Figs. 21-22; para. [0107]).
Regarding claim 16, the modified Harwood teaches wherein the manifold comprises a rigid manifold structure (manifold 104 is contrasted of relatively rigid material) (Harwood; Figs. 21-22; para. [0091]) and a flexible manifold cover configured to cover at least a portion of the rigid manifold structure (bridge or frame 62 is somewhat flexible; frame 62 covers at least a portion of the manifold 104) (Harwood; Figs. 21-22; para. [0116]).
Regarding claim 17, the modified Harwood teaches wherein the swivel connection has a first connection portion formed in the rigid manifold structure (Ratner patient member 20 is formed with detents 22; the modified Harwood manifold 104 of rigid material would thus also have that Ratner structure) (Harwood, Figs. 21-22, para. [0091]; Ratner, Figs. 1-4, para. [0030], para. [0034]) and a second connection portion formed in the connector (Ratner gas supply member 14 is formed with protrusions 19; the modified Harwood elbow 160 end would thus also have that Ratner structure) (Harwood, Figs. 21-22; Ratner, Figs. 1-4, para. [0030], para. [0034]).
Regarding claim 18, the modified Harwood teaches wherein the pair of non-sealing nasal prongs are integrally formed with the flexible manifold cover (nasal delivery elements 82 can be permanently secured to the frame 62) (Harwood; Figs. 21-22; para. [0088]).
Regarding claim 19, the modified Harwood teaches wherein the manifold comprises a rigid manifold structure (manifold 104 is contrasted of relatively rigid material) (Harwood; Figs. 21-22; para. [0091]) and a flexible manifold cover configured to cover at least a portion of the rigid manifold structure (bridge or frame 62 is somewhat flexible; frame 62 covers at least a portion of the manifold 104) (Harwood; Figs. 21-22; para. [0116]), and wherein the straps are integrally formed with the flexible manifold cover (frame 62 integrally formed opposing unlabeled arms or straps extending on either side to attach to the headgear 80) (Harwood; Figs. 21-22; para. [0089]).
Regarding claim 20, the modified Harwood teaches wherein the connector comprises a single gas tube port for connecting the manifold to only one gas tube at a time (there is only one supply tube 90 attached to the elbow 160 end, and so there would be one port with which they can fluidly communicate with each other and the manifold 104) (Harwood; Figs. 21-22; para. [0107]).
Regarding claim 21, the modified Harwood teaches wherein the manifold comprises a face mount portion configured to be placed proximate the face of the user, the face mount portion being substantially planar (manifold 104 has a portion on which the nasal delivery elements 82 sit which would be placed proximate the user’s face when in use, and which is substantially flat) (Harwood; Figs. 20-22).
Regarding claim 25, the modified Harwood teaches comprising a gas tube connected to the connector (supply tube 90 connected to the elbow 160 end) (Harwood; Figs. 21-22; para. [0107]).
Regarding claim 27, the modified Harwood teaches comprising a support attached to the gas tube between opposing ends of the gas tube and configured to support a position of the gas tube when the gas tube is manipulated (hose attachment clip 172 can be attached to supply tube 90 between its ends to support the position of the tube 90, which can be manipulated as it is flexible) (Harwood; Figs. 21-22, 31; para. [0087]; para. [0118]).
Regarding claim 28, the modified Harwood teaches the nasal cannula according to claim 1 (see rejection of claim 1 above); and a gas supply configured to supply gas to the user via the gas tube (flow generator 52 supplies gas to the user via the supply tube 90) (Harwood; Figs. 1, 21-22; para. [0087]).
Regarding claim 29, the modified Harwood teaches wherein the nasal cannula further comprises a pair of opposing straps extending from the manifold and wherein the opposing straps are each releasably attached to a patient head band (frame 62 has opposing unlabeled arms or straps extending on either side to releasably attach to the headgear 80 via clips or a hook-and-loop arrangement) (Harwood; Figs. 21-22; para. [0089]).
Regarding claim 34, the modified Harwood teaches wherein the nasal cannula comprises a detent configured to releasably restrict the angular position of the connector (swivel connector 10 has either the patient member 20 or the gas supply member 14 with detents 22 to interface with protrusions 19 on the other of the patient member 20 or the gas supply member 14; the detents 22 and protrusions 19 allow for relative rotation between the patient member 20 or the gas supply member 14 when enough force is applied to overcome the restriction of resistance) (Ratner; Fig. 4; para. [0030]; para. [0034]).
Regarding claim 35, the modified Harwood teaches wherein the manifold comprises a first connection portion (Ratner patient member 20 end with a detent 22; the modified Harwood manifold 104 of rigid material would thus also have that Ratner structure) (Harwood, Figs. 21-22, para. [0091]; Ratner, Figs. 1-4, para. [0030], para. [0034]), the connector comprises a second connection portion (Ratner gas supply member 14 end with a protrusion 19; the modified Harwood elbow 160 end would thus also have that Ratner structure) (Harwood, Figs. 21-22; Ratner, Figs. 1-4, para. [0030], para. [0034]), and the first connection portion and second connection portion cooperate to form the swivel connection (a detent 22 interfaces with a protrusion 19 to hold the patient member 20/gas supply member 14 in a particular position of rotation with respect to each other until a user applies the torque for their relative rotation) (Ratner; Fig. 4; para. [0030]; para. [0034]), and wherein the first connection portion and second connection portion comprise a retainer configured to selectively hold the connector in the plurality of angular positions relative to the manifold (collar 12 fits over the gas supply member 14 and patient member 20 ends to hold them together while allowing for their relative rotation; alternatively, other ones of the detents 22 and/or protrusions 19 can teach the retainer as they would also function to hold the gas supply member 14 and patient member 20 in a desired position of rotation) (Ratner; Figs. 1-4; para. [0030]; paras. [0033-0034]).
Claims 3-4 are rejected under 35 U.S.C. 103 as being unpatentable over Harwood in view of Price, Mraz, and Ratner as applied to claim 2 above, and further in view of Allan et al. (US 2011/0146685 A1).
Regarding claim 3, the modified Harwood teaches the invention as previously claimed, but is silent on wherein the elbow is configured to redirect gas flow at an angle greater than 30 degrees.
However, Allan teaches a patient interface (Allan; abstract) wherein the elbow is configured to redirect gas flow at an angle greater than 30 degrees (swivel elbow 313 defines an angle between flow in the conduit and to the mask connection of preferably 45 degrees) (Allan; Figs. 3A-3C, 5B-5C; para. [0433]).
Therefore, 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 Harwood elbow such that the elbow is configured to redirect gas flow at an angle greater than 30 degrees, as taught by Allan, for the purpose of providing the elbow with a specific suitable angle for delivering gas flow to a patient interface.
Regarding claim 4, the modified Harwood teaches wherein the swivel connection has an axis of rotation configured to be substantially normal to a face of the user (swiveling elbow can pivot about an axis perpendicular to connection with mask, and thus perpendicular or normal to the patient’s face) (Allan; Figs. 3A-3C, 5B-5C; para. [0407]).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Harwood in view of Price, Mraz, and Ratner as applied to claim 1 above, and further in view of Gunaratnam et al. (US 2005/0241644 A1).
Regarding claim 6, the modified Harwood teaches the invention as previously claimed, bit does not teach wherein the swivel connection is configured to limit the relative rotation to an angle range less than 360 degrees.
However, Gunaratnam teaches a nasal assembly (Gunaratnam; abstract) wherein the swivel connection is configured to limit the relative rotation to an angle range less than 360 degrees (movement of air delivery tube 606 is confined by swivel stops 631, 632 to allow for between 220-300 degrees of rotation) (Gunaratnam; Figs. 7-8; para. [0064-0065]; para. [0069]).
Therefore, 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 Harwood swivel connection such that the swivel connection is configured to limit the relative rotation to an angle range less than 360 degrees, as taught by Gunaratnam, for the purpose of ensuring undesirable contact between the air delivery tube and the patient is minimized or avoided (Gunaratnam; para. [0065]).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Harwood in view of Price, Mraz, and Ratner as applied to claim 1 above.
Regarding claim 10, the modified Harwood teaches the invention as previously claimed, but does not explicitly disclose wherein the gas tube has a substantially constant internal cross-sectional area.
However, Harwood does suggest wherein the gas tube has a substantially constant internal cross-sectional area (as illustrated in Figs. 15, 18, 21-23, the supply tube 90 appears to have a substantially constant internal cross-section area, as no internal section appears to expand outward or taper inward).
Therefore, 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 Harwood gas tube such that the gas tube has a substantially constant internal cross-sectional area, as suggested by Harwood, for the purpose of helping to ensure the gas flow is delivered to the patient with minimal changes in flow speed and turbulence along the gas tube length.
Claims 22 and 30 are rejected under 35 U.S.C. 103 as being unpatentable over Harwood in view of Price, Mraz, and Ratner as applied to claims 1 and 28 above, and further in view of Lewis et al. (US 2007/0175473 A1).
Regarding claim 22, the modified Harwood teaches the invention as previously claimed, but is silent on being configured to deliver a flow rate of less than 100 Standard litres per minute.
However, Lewis teaches a high flow therapy system with a patient interface (Lewis; abstract) wherein it is configured to deliver a flow rate of less than 100 Standard litres per minute (system is adapted to deliver a gas flow between 40-60 liters per minute) (Lewis; para. [0104]).
Therefore, 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 Harwood device such that it is configured to deliver a flow rate of less than 100 Standard litres per minute, as taught by Lewis, for the purpose of providing the device with a specific flow rate suitable for a patient’s high airflow therapy (Lewis; para. [0104]; claims 12-13).
Regarding claim 30, the modified Harwood teaches wherein the system is configured for high flow oxygen therapy (system is adapted to deliver oxygen with high flow nasal therapy) (Lewis; abstract; para. [0097]).
Claim 23 is rejected under 35 U.S.C. 103 as being unpatentable over Harwood in view of Price, Mraz, and Ratner as applied to claim 1 above, and further in view of Prentice et al. (US 2014/0174446 A1).
Regarding claim 23, the modified Harwood teaches the invention as previously claimed, but does is silent on wherein the swivel connection is non air-tight.
However, Prentice teaches an interface assembly (Prentice; abstract) wherein the swivel connection is non air-tight (swivel 210 has leakage of 0.05-0.4 L/min at 10 cm H2O) (Prentice; para. [0098]).
Therefore, 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 Harwood swivel connection mechanism to be non air-tight, as taught by Prentice, for the purpose of providing the device with a minimized leakage between components (Prentice; para. [0091]; para. [0098]) which one of ordinary skill in the art could feasibly consider suitable for a swivel connection of a patient breathing interface.
Claim 24 is rejected under 35 U.S.C. 103 as being unpatentable over Harwood in view of Price, Mraz, Ratner, and Prentice as applied to claim 23 above, and further in view of Lewis.
Regarding claim 24, the modified Harwood teaches the invention as previously claimed, but does not teach wherein the swivel connection is configured to allow gas leakage below 10% at flows of up to 50 Standard litres per minute.
However, Lewis teaches a high flow therapy system with a patient interface (Lewis; abstract) wherein it is configured to deliver flows of up to 50 Standard litres per minute (system is adapted to deliver a gas flow of 40 liters per minute) (Lewis; para. [0104]). Moreover, Prentice already teaches an interface assembly (Prentice; abstract) wherein the swivel connection is configured to allow gas leakage (swivel 210 has leakage of 0.05-0.4 L/min) (Prentice; para. [0098]). The Prentice swivel gas leakage of 0.05-0.4 L/min is below 10% of the Lewis gas flow of 40 L/min.
Therefore, 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 modified Harwood swivel connection such that the swivel connection is configured to allow gas leakage below 10% at flows of up to 50 Standard litres per minute, as taught by Prentice and Lewis, for the purpose of ensuring the leakage is reduced (Prentice; para. [0098]) while also providing the device with a specific flow rate suitable for a patient’s high airflow therapy (Lewis; para. [0104]; claims 12-13).
Claim 26 is rejected under 35 U.S.C. 103 as being unpatentable over Harwood in view of Price, Mraz, and Ratner as applied to claim 25 above, and further in view of Wondka (US 2005/0066976 A1).
Regarding claim 26, the modified Harwood teaches the invention as previously claimed, but does not disclose wherein the gas tube is malleable or comprises a malleable member, such that the gas tube is configured to be deformable and retain a given shape when the gas tube is manipulated.
However, Wondka teaches a nasal ventilation interface (Wondka; abstract) wherein the gas tube is malleable or comprises a malleable member, such that the gas tube is configured to be deformable and retain a given shape when the gas tube is manipulated (interface tubes 32, which deliver ventilation gas to a user, have an integral malleable member; malleable members can be shaped and re-shaped repeatedly by a user) (Wondka; Figs. 5A-5B, 19A-19B; para. [0082]; para. [0103]; para. [0166]; para. [0173]).
Therefore, 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 Harwood gas tube such that the gas tube is malleable or comprises a malleable member, such that the gas tube is configured to be deformable and retain a given shape when the gas tube is manipulated, as taught by Wondka, for the purpose of allowing the gas tube to be curved optimally to fit a patient’s anatomy (Wondka; para. [0103]).
Response to Arguments
Applicant's arguments filed 8/11/2026 have been fully considered but they are not persuasive.
On page 11 in the “Objections to the Drawings”, “Claim Objections”, and “Rejections under 35 U.S.C. 112(b)” sections of the Applicant’s remarks, the Applicant argues that the drawings and claims have been amended to overcome the objections and 35 U.S.C. 112(b) rejections of the previous office action. The Examiner agrees and has thus withdrawn those objections and 35 U.S.C. 112(b) rejections.
Applicant’s arguments on pages 11-15 in the “Rejections under 35 U.S.C. 103” section of the Applicant’s remarks have been considered but are moot in view of new grounds of rejection with new additional Mraz and Ratner references being used in the current rejection as discussed above.
Conclusion
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/JACQUELINE M PINDERSKI/Examiner, Art Unit 3785
/RACHEL T SIPPEL/Primary Examiner, Art Unit 3785
