616DETAILED 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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 10/8/2025 has been entered.
Response to Arguments
Applicant’s arguments with respect to claim(s) 65-68, 70-73, 77, 79-80,83-86, and 90-91 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 Examiner notes that while the same prior art from the final rejection dated 4/8/2925 is still being relied upon in the current office action, a different interpretation of the references is now being used.
Regarding the 112a rejection previously set forth in the final office action, the Examiner maintains that even with the amended language to claim 65, the claim remains unclear. Paragraph 0403 and Figure 2c of Application’s specification clearly describes the first and second ends of the headband as being 12a and 12b, with the flexible joints 13 disposed above the first and second ends. Therefore, the Examiner maintains that none of Applicant’s figures show the flexible joints positioned at the first or second ends (or end portions) of the headband, as the claim recites. Rather, the flexible joints 13 appear to be located near the center of the headband.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 65, and thus its dependent claims, are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 65 has been amended to recite “a first flexible joint positioned at or on the first end of the resilient headband and a second flexible joint positioned at or on the second end of the resilient headband”. However, paragraph 0403 and Figure 2c of Applicant’s specification describes the first and second ends of the headband as being 12a and 12b, with the flexible joints being element 13, therefore none of Applicant’s figures show the flexible joints 13 being positioned at or on the first and/or second ends of the headband.
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 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 65-66, 68, 70, 83-84, 86 and 91 are rejected under 35 U.S.C. 103 as being unpatentable over Huddart et al. (US 2016/0144146 A1) in view of McDonald et al. (US 6,595,207 B1).
Regarding claim 65, Huddart discloses a headgear for a patient interface comprising (headgear portion 620 for a mask 610, Figure 20 and Paragraph 0331): at least one headgear member connectable to the patient interface separate any tube or conduit that provides a flow of respiratory gases to the interface (headgear 620 attached to the patient interface 610 via an adjustment portion 630, respiratory gases do not flow through portion 630, Paragraph 0331 and Figure 20); a pair of flexible joints formed from a soft flexible material that is adapted to connect the at least one headgear member to the patient interface (the adjustment portions 630 comprise a stretchable material 640 such as a braided material, adjustment portion 630 connects the headgear strap to the patient interface 610, Paragraph 0332 and Figure 20) each of the pair of flexible joints attached to a respective end or end portion of the resilient head band (each adjustment portion 630 is located at a respect end 680 of the headgear portion, Figure 20), each of the pair of flexible joints allowing free relative movement with at least two degrees of freedom between the at least one headgear member and the patient interface or the adjacent headgear member, or any combination thereof (the stretchable material 640 of the adjustment portions 630 fully capable of being stretched in various directions, therefore allowing for at least two degrees of freedom, Paragraph 0332); wherein each of the pair of flexible joints is disposed about and forms a unitary and integral member with an end of the resilient headband (adjustment portions 630 may be a unitary/integral part of the headgear arrangement, Paragraph 0331), the first flexible joint positioned at or on the first or end and the second flexible joint positioned at or on the second end of the resilient headband to engage the user's head to hold the headgear in place (each adjustment portion 630 is located at a respect end 680 of the headgear portion, Figure 20; the adjustment portions 630 allow for the adjusting of the headgear in the desired position and therefore assisting in holding the headgear in place, Paragraph 0331).
However, although Huddart teaches a headgear assembly (Figure 20), Huddart doesn’t explicitly state the at least one headgear member comprising a resilient headband comprising an arcuate shape extending between a first end and a second end, the resilient headgear configured to have having a bias towards an undeflected shape, wherein, in the undeflected shape, a first lateral distance between the first end and the second is less than a second lateral between left and right side portions of the resilient headband at a point intermediate between the first and second ends and a top of the resilient headband; wherein, during use, each of the first end and the second end of the resilient headband is deflected outwardly from the undeflected shape by a user's head causing the bias towards the undeflected shape to apply a lateral force at each of the first end and the second end of the resilient headband.
However, McDonald teaches a headgear for a patient interface assembly (Abstract and Figure 1) comprising least one headgear member comprising a resilient headband comprising an arcuate shape extending between a first end and a second end (curved resilient headband 6 extending between a first end and second end comprising pads 10, Col. 3 lines 12-13 and Figure 1), the resilient headgear configured to have having a bias towards an undeflected shape (due to the headband 6 being resilient, when the headband 6 is not being worn it maintains its original undeflected shape, Figure 1), wherein, in the undeflected shape (Figure 1), a first lateral distance between the first end and the second is less than a second lateral between left and right side portions of the resilient headband at a point intermediate between the first and second ends and a top of the resilient headband (the first lateral distance between the first and second end of the headband 6 is less than an intermediate lateral distance between left and right side portions 8 of the headband 6 due to the curved nature of the headband 6, Figure 1); wherein, during use, each of the first end and the second end of the resilient headband is deflected outwardly from the undeflected shape by a user's head causing the bias towards the undeflected shape to apply a lateral force at each of the first end and the second end of the resilient headband (when the resilient headband 6 is being worn by a user, the ends of the headband would therefore deflect outwardly as the user positions the headband 6 onto his/her head, applying a lateral force, Figure 1).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify Huddart’s headgear assembly by having a resilient headband configured to have a bias towards an undeflected shape, as taught by McDonald, as providing such a resilient headband structure may aide in preventing slippage of the headgear assembly by the application of lateral forms onto the user’s head when the headband is deflected outwards when being worn, improving the overall fit of the headgear assembly.
Regarding claim 66, Huddart in view of McDonald teach the headgear of claim 65, with Huddart further teaching wherein the pair of flexible joints (adjustment portions 630, Figure 20 and Paragraph 0331) can elongate to allow free relative movement between the at least one headgear member and the patient interface or the adjacent headgear member, or any combination thereof (the stretchable nature of adjustment portion 630 permits an adjustment of distance between the mask 610 and the headgear, Paragraph 0331).
Regarding claim 68, Huddart in view of McDonald teach the headgear of claim 65, with Huddart further teaching wherein each of the pair of flexible joints can bend or fold laterally to a longitudinal axis of an end portion of the at least one headgear member (adjustment portion 630 comprises stretchable material 640 which may be braided material incorporating stretch elements, therefore fully capable of bending and folding laterally along a longitudinal axis of an end portion of the headgear member, Paragraph 0332).
Regarding claim 70, Huddart in view of McDonald teach the headgear of claim 65, with Huddart further teaching wherein each of the pair of flexible joints is an elastomeric member or a hollow tubular member, or any combination thereof (adjustment portion 630 comprises stretchable material 640 which can be configured to return towards its non-stretched position, therefore demonstrating elastomeric properties, Paragraph 0332).
Regarding claim 83, Huddart further teaches wherein an end of the at least one headgear member extends beyond at least one of the pair of flexible joints (see at least one headgear member portion extending beyond the adjustment portions 630, Figure 20).
Regarding claim 84, Huddart in view of McDonald teach the headgear of claim 65, with Huddart further teaching wherein each of the pair of flexible joints engages a respective side of a user's head in use (see adjustment portion 630 engaging a respective side of a user’s head while in use, Figure 20).
Regarding claim 86, Huddart in view of McDonald teach the headgear of claim 65, with McDonald further teaching wherein the resilient headband (headband 6, Figure 1) is shaped to fit a user's head with each end of the resilient headband located to and biased against a respective side of the user's head (see each respective end of the resilient headband 6 located to and biased against a respective side of the user’s head when the device is worn, Figure 1).
Regarding claim 91, Huddart discloses a headgear for a patient interface comprising (headgear portion 620 for a mask 610, Figure 20 and Paragraph 0331): a headband connectable to the patient interface separate any tube or conduit that provides a flow of respiratory gases to the interface (headgear 620 attached to the patient interface 610 via an adjustment portion 630, respiratory gases do not flow through portion 630, Paragraph 0331 and Figure 20); a pair of flexible joints formed from a soft flexible material that is adapted to connect the at least one headgear member to the patient interface (the adjustment portions 630 comprise a stretchable material 640 such as a braided material, adjustment portion 630 connects the headgear strap to the patient interface 610, Paragraph 0332 and Figure 20) each of the pair of flexible joints attached to a respective end or end portion of the head band (each adjustment portion 630 is located at a respect end 680 of the headgear portion, Figure 20), each of the pair of flexible joints allowing free relative movement with at least two degrees of freedom between the at least one headgear member and the patient interface or the adjacent headgear member, or any combination thereof (the stretchable material 640 of the adjustment portions 630 fully capable of being stretched in various directions, therefore allowing for at least two degrees of freedom, Paragraph 0332); wherein one of the pair of flexible joints is disposed about a first end or end portion of the headband and another of the pair of flexible joints is disposed about a second end or end portion of the headband (each adjustment portion 630 is located at a respect end 680 of the headgear portion, Figure 20), wherein each of the pair of flexible joints comprises a hollow tubular member (adjustment portions 630 are tubular members, Figure 20; see also the embodiment shown in Figure 19 with paragraph 0330 describe the adjustment portion as a hollow conduit), each of the pair of flexible joints allowing free relative movement with at least two degrees of freedom between the at least one headgear member and the patient interface or the adjacent headgear member, or any combination thereof (the stretchable material 640 of the adjustment portions 630 fully capable of being stretched in various directions, therefore allowing for at least two degrees of freedom, Paragraph 0332).
However, although Huddart teaches a headgear assembly (Figure 20), Huddart doesn’t explicitly state the at least one headgear member comprising a resilient headband comprising an arcuate shape extending between a first end and a second end, the resilient headgear configured to have having a bias towards an undeflected shape, wherein, in the undeflected shape, a first lateral distance between the first end and the second is less than a second lateral between left and right side portions of the resilient headband at a point intermediate between the first and second ends and a top of the resilient headband; wherein, during use, each of the first end and the second end of the resilient headband is deflected outwardly from the undeflected shape by a user's head causing the bias towards the undeflected shape to apply a lateral force at each end of the resilient band against the user’s head to hold the headgear in place.
However, McDonald teaches a headgear for a patient interface assembly (Abstract and Figure 1) comprising least one headgear member comprising a resilient headband comprising an arcuate shape extending between a first end and a second end (curved resilient headband 6 extending between a first end and second end comprising pads 10, Col. 3 lines 12-13 and Figure 1), the resilient headgear configured to have having a bias towards an undeflected shape (due to the headband 6 being resilient, when the headband 6 is not being worn it maintains its original undeflected shape, Figure 1), wherein, in the undeflected shape (Figure 1), a first lateral distance between the first end and the second is less than a second lateral between left and right side portions of the resilient headband at a point intermediate between the first and second ends and a top of the resilient headband (the first lateral distance between the first and second end of the headband 6 is less than an intermediate lateral distance between left and right side portions 8 of the headband 6 due to the curved nature of the headband 6, Figure 1); wherein, during use, each of the first end and the second end of the resilient headband is deflected outwardly from the undeflected shape by a user's head causing the bias towards the undeflected shape to apply a lateral force at each of the first end and the second end of the resilient headband (when the resilient headband 6 is being worn by a user, the ends of the headband would therefore deflect outwardly as the user positions the headband 6 onto his/her head, applying a lateral force, Figure 1).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify Huddart’s headgear assembly by having a resilient headband configured to have a bias towards an undeflected shape, as taught by McDonald, as providing such a resilient headband structure may aide in preventing slippage of the headgear assembly by the application of lateral forms onto the user’s head when the headband is deflected outwards when being worn, improving the overall fit of the headgear assembly.
Claim(s) 67, 71 and 73 are rejected under 35 U.S.C. 103 as being unpatentable over Huddart et al. (US 2016/0144146 A1) in view of McDonald et al. (US 6,595,207 B1) and in further view of Pastoor et al. (US 2015/0202397 A1).
Regarding claim 67, Huddart in view of McDonald teach the headgear of claim 65, however are silent wherein each of the pair of flexible joints comprises a hinge.
However, Pastoor teaches a headgear for a patient interface comprising (patient interface assembly 10 comprising a headgear assembly 30, Paragraph 0049 and Figure 1): at least one headgear member connectable to the patient interface separate of any tube or conduit that provides a flow of respiratory gases to the patient interface (headgear assembly 30 comprises two straps 32 and 34 to thereby attach to the patient interface 20, Paragraph 0049 and Figure 1; headgear assembly 30 attaches to patient interface without any tubes or conduits that provide a flow of respiratory gases, as the respiratory gases are provided through connector 23 in which supplies gases to the patient, Paragraph 0048 and Figure 1); and a pair of flexible joints (pair of force limiters 40 comprising a spring-like element 49 implemented as a special section of strap 32 having a higher degree of flexibility, Paragraph 0063 and Figure 5A), formed from a soft flexible material (force limiter 40 may be made from an elastic material such as silicone and/or rubber, Paragraph 0033), wherein the flexible joints comprise a hinge (In light of Applicant’s specification, the hinge of the flexible joint is described as “a narrowed portion” in Paragraph 0302; therefore, the force limiter 40 as shown in Figure 6 comprising a flexible bellows structure 51, comprising a plurality of narrowed portions, similarly comprises a hinge as described by Applicant’s specification, Paragraph 0066).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify Huddart’s headgear assembly by having the flexible joints include a hinge in the form of a narrowed portion, such as a flexible bellows portion, as taught by Pastoor, as such a bellows-like structure may further aide in the flexibility of the connection between the headgear member and the patient interface, improving the overall adjustability of the headgear assembly.
Regarding claim 71, Huddart in view of McDonald teach the headgear of claim 65, however are silent wherein each of the pair of flexible joints or the at least one headgear member comprises a connecting structure that is releasably attachable to the patient interface or an adjacent headgear member.
However, Pastoor teaches a headgear for a patient interface comprising (patient interface assembly 10 comprising a headgear assembly 30, Paragraph 0049 and Figure 1): at least one headgear member connectable to the patient interface separate of any tube or conduit that provides a flow of respiratory gases to the patient interface (headgear assembly 30 comprises two straps 32 and 34 to thereby attach to the patient interface 20, Paragraph 0049 and Figure 1; headgear assembly 30 attaches to patient interface without any tubes or conduits that provide a flow of respiratory gases, as the respiratory gases are provided through connector 23 in which supplies gases to the patient, Paragraph 0048 and Figure 1); and a pair of flexible joints (pair of force limiters 40 comprising a spring-like element 49 implemented as a special section of strap 32 having a higher degree of flexibility, Paragraph 0063 and Figure 5A), formed from a soft flexible material (force limiter 40 may be made from an elastic material such as silicone and/or rubber, Paragraph 0033), wherein the flexible joints comprise a connecting structure that is releasably attachable to the patient interface or an adjacent headgear member (the force limiter 40 as shown in Figure 3 comprises a hook 43 that is adapted to engage with an opening 26 of the patient interface, Paragraph 0051).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify Huddart’s headgear assembly by including flexible joints comprising a connecting structure releasably attachable to the patient interface, as further taught by Pastoor, as providing such a connecting structure would allow for a quick and effective means of removing the flexible joints and/or headgear straps from the patient interface as needed, such as if the patient desires for the straps to be cleaned after multiple uses.
Regarding claim 73, Pastoor further teaches an alternative embodiment wherein the connecting structure comprises a recess or aperture that receives a projection or boss (force limiter 40 as shown in Figure 3 comprises a slot 44 that receives end of strap 35, Paragraph 0051 and Figure 3).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify McDonald’s headgear assembly by having the flexible joints comprise a connecting structure comprising a recess or aperture that receives a projection, as further taught by Pastoor, as providing such a connecting structure would allow for a quick and effective means of removing the flexible joints and/or headgear straps from the patient interface as needed, such as if the patient desires for the straps to be cleaned after multiple uses.
Claim 72 is rejected under 35 U.S.C. 103 as being unpatentable over Huddart et al. (US 2016/0144146 A1) in view of McDonald et al. (US 6,595,207 B1), Pastoor et al. (US 2015/0202397 A1) and in further view of Busch et al. (US 2013/0008449 A1).
Regarding claim 72, Huddart in view of McDonald and Pastoor teach the headgear of claim 71, however is silent wherein the connecting structure provides a pivotal connection.
However, Busch teaches a headgear assembly attached to a patient interface separate of any tubing and/or conduits (headgear component 18 connected to patient interface 10 via a first and second mask attachment element 22, Figure 1 and Paragraph 0015) wherein the pair of mask attaching elements are made from a soft, flexible material (mask attachment element 22 comprises a flexible linkage portion 28 made from a material that is softer and more flexible than both mask attachment portion and strap attachment portion, such as silicone rubber, Paragraph 0020) and also comprise a connecting structure with a pivotable connection (ball and socket coupling may be used in place of the hooked portion in order to connect to patient interface 10, which would then provide a pivotal connection, Paragraph 0018).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify Huddart’s headgear assembly by including flexible joints comprise a connecting structure with a pivotable connection, as taught by Busch, as providing such a pivoting connecting structure would provide the flexible joints with a larger range of motion, and therefore increase the overall adjustability of the headgear assembly.
Claims 77, 79-80 are rejected under 35 U.S.C. 103 as being unpatentable over Huddart et al. (US 2016/0144146 A1) in view of McDonald et al. (US 6,595,207 B1) and in further view of McLaren et al. (US 2015/0283349 A1).
Regarding claim 77, Huddart in view of McDonald teach the headgear of claim 65, however are silent wherein the at least one headgear member is moveably attached to each of the pair of flexible joints such that the at least one headgear member can move relative to the adjacent headgear member along a longitudinal axis of the at least one headgear member.
However, McLaren teaches an adjustable headgear assembly for use with a patient interface (Abstract, Figure 38) comprising at least one headgear member (post 424 connected to patient interface frame 430, Figure 38) that is moveable attached to a flexible joint (post 424 may be moveably attached to resilient sleeve 422 by inserting post 424 to a desired length within passage of sleeve 422, Figure 38 and Paragraph 0164) such that the headgear member can move relative to an adjacent headgear member along a longitudinal axis (post 424 can move relative to adjacent headgear strap 476, Figure 38 and Paragraph 0164).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify Huddart’s headgear assembly by including at least one headgear member that is moveably attached to a flexible joint such that the headgear member can move relative to an adjacent headgear member, as taught by McLaren, as this would provide additional adjustability to the overall headgear assembly, further assisting in providing the user with a customized fit.
Regarding claim 79, McLaren further teaches wherein each of the pair of flexible joints comprises at least one passageway that allows a passage of the at least one headgear member (flexible sleeve 422 comprises a passage that allows for the insertion of post 424, Figure 38 and Paragraph 0164).
Regarding claim 80, McLaren further teaches wherein the at least one headgear member comprises at least one stop to limit movement of the at least one headgear member relative to each of the pair of flexible joints or the at least one passageway of each of the pair of flexible joints, or any combination thereof (tabs 458 within passage 456 resist withdrawal of the post 454 from the flexible sleeve 452, therefore limiting movement between the post 454 and the flexible sleeve 452, Paragraph 0166 and Figures 41-42).
Therefore, it would have been obvious at the time of invention to further modify the adjusting mechanism of Huddart in view of McDonald, as described in the claim 77 analysis, to include at least one stop and/or tab that limits movement between the two components, as further described by McLaren, as this would prevent unwanted movement between the two components and provide a more secure fit.
Claim 85 is rejected under 35 U.S.C. 103 as being unpatentable over Huddart et al. (US 2016/0144146 A1) in view of McDonald et al. (US 6,595,207 B1) and in further view of Huddart et al. (US 2016/0074614 A1).
Regarding claim 85, Huddart in view of McDonald (‘146) teaches the headgear of claim 65, however doesn’t explicitly state wherein the at least one headgear member is formed from a stiff resilient material, wherein a modulus of elasticity of the stiff resilient material is greater than a modulus of elasticity of the soft flexible material.
However, Huddart (‘614) teaches a headgear assembly comprising a headgear component (headgear 4100 comprises a top strap 4140, rear strap 4150, and front strap 4160, Figure 1A) connected to a patient interface device (connector 4180 connects straps to breathing apparatus 4110, Figure 1A), further teaching the headgear member comprising a resilient headband (headgear 4100 comprising a top strap 4140 includes a plastic composition core 4220, offering the benefit of a resilient structure, Paragraph 0294) wherein the at least one headgear member is formed from a stiff resilient material (headgear 4100 comprising a top strap 4140 includes a plastic composition core 4220, offering the benefit of a resilient structure, Paragraph 0294), wherein the modulus of elasticity of the stiff resilient material is greater than the modulus of elasticity of the soft flexible material (modulus of elasticity of a rigid or semi rigid material is greater than a soft flexible material used in the flexible linkage portion 46).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify Huddart in view of McDonald by having the headgear member be formed from a stiff resilient material while having the flexible joints be formed from a soft flexible material, as providing the headgear member with a more stiff/rigid material as compared to the flexible joints would provide the headgear components with greater structural integrity, while allowing the headgear assembly to flex in certain areas to allow the user to make minor adjustments in size.
Claim 90 is rejected under 35 U.S.C. 103 as being unpatentable over Pastoor et al. (US 2015/0202397 A1) in view of Huddart et al. (US 2016/0074614 A1).
Regarding claim 90, Pastoor discloses a headgear for a patient interface comprising (patient interface assembly 10 comprising a headgear assembly 30, Paragraph 0049 and Figure 1):at least one headgear member connectable to the patient interface separate of any tube or conduit that provides a flow of respiratory gases to the patient interface (headgear assembly 30 comprises two straps 32 and 34 to thereby attach to the patient interface 20, Paragraph 0049 and Figure 1; headgear assembly 30 attaches to patient interface without any tubes or conduits that provide a flow of respiratory gases, as the respiratory gases are provided through connector 23 in which supplies gases to the patient, Paragraph 0048 and Figure 1); a pair of flexible joints (pair of force limiters 40 comprising a spring-like element 49 implemented as a special section of strap 32 having a higher degree of flexibility, Paragraph 0063 and Figure 5A), formed from a soft flexible material (force limiter 40 may be made from an elastic material such as silicone and/or rubber, Paragraph 0033) that is adapted to connect the at least one headgear member to the patient interface or an adjacent headgear member, or any combination thereof (force limiter 40 is connected to headgear strap 32 having a first side 36 and a second side 37, Figure 5A and Paragraph 0063)and wherein each of the pair of flexible joints allowing free relative movement with at least two degrees of freedom between the at least one headgear member and the patient interface or the adjacent headgear member, or any combination thereof (force limiter 40 is made from a flexible, elastic material therefore may flex/bend with at least two degrees of freedom between either the adjacent headgear strap 32 or the patient interface 20, Figure 1 and Paragraph 0033) and wherein the at least one headgear member does not extend about a rear portion of a patient's head (see headgear strap 34 not extending about a rear portion of the patient’s head, Figure 1).
However, although Pastoor further teaches the headgear member having an increased stiffness than that of the flexible force limiter (Paragraph 0063), Pastoor doesn’t explicitly state the at least one headgear member comprising a resilient headband having a bias towards an undeflected shape such that, during use, each end of the resilient headband is deflected outwardly by a user's head causing the bias towards the undeflected shape to apply a lateral force at each end of the resilient band against the user's head to hold the headgear in place;
However, Huddart teaches a headgear assembly comprising a headgear component (headgear 4100 comprises a top strap 4140, rear strap 4150, and front strap 4160, Figure 1A) connected to a patient interface device (connector 4180 connects straps to breathing apparatus 4110, Figure 1A), further teaching the headgear member comprising a resilient headband (headgear 4100 comprising a top strap 4140 includes a plastic composition core 4220, offering the benefit of a resilient structure, Paragraph 0294) having a bias towards an undeflected state such that, during use, each end of the resilient headband is deflected outwardly by a user’s head causing the bias towards the undeflected shape to apply a lateral force at each end of the resilient headband against the user’s head to hold the headgear in place (the plastic core 4220 provides a resilient structure that is capable of maintaining a preformed shape while conforming somewhat to the individual cranial geometry of the user while in use, the plastic core 4220 allows the headgear 4100 to be flexible in a horizontal direction in order to conform to user’s head while providing rigidity to stabilize the breathing apparatus 4110 of the user’s face, Paragraph 0294 and Figures 1A and 2).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify Pastoor’s headgear assembly to include a resilient headband component that is biased towards an undeflected shape such that during use, the headband is deflected outwardly by the user’s head, as taught by Huddart, as providing such a resilient structure for a headgear component provides flexibility to allow the headgear to conform to the user’s head while also providing rigidity that stabilizes and minimizes dislodging of the breathing apparatus on the user’s face (Paragraph 0294 of Huddart).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARAH B LEDERER whose telephone number is 571-272-7274. The examiner can normally be reached on Monday - Friday, 7:30 AM - 4:30 PM.
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/SARAH B LEDERER/Examiner, Art Unit 3785
/MARGARET M LUARCA/ Primary Examiner, Art Unit 3785