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
The amendments filed 3/2/2026 have been entered. Accordingly, claims 1-13, and 72-78 are pending in the current application.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-13, and 72-78 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 upon further search and consideration, a new reference is now being applied to better reflect the claim limitations.
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.
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.
Claim(s) 1-4, 6-9, 11-12 and 72-77 rejected under 35 U.S.C. 103 as being unpatentable over Baigent (WO 2016/082001 A1) in view of Scheiner et al. (US 2015/0342306 A1) and further in view of Scott et al. (US 2018/0221191 A1).
Regarding claim 1, Baigent discloses a patient interface for sealed delivery of a flow of air at a continuously positive pressure with respect to ambient air pressure to an entrance to a patient's airways including at least entrance of a patient's nares (patient interface 3000 for sealed delivery of a flow of air at a continuously positive pressure to an entrance of a patient’s nares, Abstract and Figure 43), wherein the patient interface is configured to maintain a therapy pressure in a range of about 4 cmH20 to about 30 cmH20 above ambient air pressure in use (positive pressure delivered to patient at about 10 cm H20 relative to ambient pressure, therefore within the claimed pressure range, Paragraph 0021), throughout a patient's respiratory cycle, while the patient is sleeping, to ameliorate sleep disordered breathing (positive pressure of 10 cm H20 delivered to patient throughout respiratory cycle, while patient is sleeping, in order to ameliorate sleep disordered breathing, Paragraph 0071), the patient interface comprising: a cushion assembly configured to deliver a flow of air to the patient's airways (seal forming structure 3100, Figure 30 and Paragraph 0299), the cushion assembly including: a plenum chamber at least partially forming a cavity pressurisable to a therapeutic pressure of at least 6 cmH20 above ambient air pressure (plenum chamber 3200, Figures 30 and 43 and Paragraph 0288; positive pressure delivered to patient at about 10 cm H20 relative to ambient pressure, therefore within the claimed pressure range, therefore at least 6 cm H20 Paragraph 0021), said plenum chamber including a plenum chamber inlet port sized and structured to receive the flow of air at the therapeutic pressure for breathing by a patient (plenum chamber 3200 comprises connection port 3600 for connection to air circuit 4170, Figure 43 and Paragraph 0288); and a seal-forming structure constructed and arranged to form a seal with a region of the patient's face surrounding an entrance to the patient's airways (seal forming structure 3100 comprising sealing regions 3113 to form seal with a region of the patient’s face surrounding the patients airway, Paragraph 0339 and Figure 44), said seal-forming structure having a hole formed therein such that the flow of air at said therapeutic pressure is delivered to at least an entrance to the patient's nares (sealing structure 3100 having holes formed therein such that the flow of air is delivered to patient’s nares, Figure 44), the seal-forming structure constructed and arranged to maintain said therapeutic pressure in the cavity throughout the patient's respiratory cycle in use (sealing cushion arranged such that therapeutic pressure is maintained throughout the patient’s respiratory cycle in use, Paragraph 0075); and a positioning and stabilising structure to provide a force to hold the seal-forming structure in a therapeutically effective position on the patient's head (positioning and stabilizing structure 3300, Figures 30 and 55 and Paragraph 0369), the positioning and stabilising structure being constructed and arranged so that at least a portion overlies a region of the patient's head superior to an otobasion superior of the patient's head in use (see rear strap 3305 of stabilizing structure 3300, Figure 55 and Paragraph 0296), wherein the positioning and stabilizing structure comprises a headgear strap (see stabilizing structure 3300 comprising a various headgear straps, Figure 55 and Paragraph 0319), the knitted headgear strap including: at least one first area having a first knit structure (see side strap 3301 comprising a first area comprised of a first knit structure 3316, Paragraph 0424 and Figure 55); and at least one second area having a second knit structure having increased stretchability as compared to the at least one first area (see rear strap 3305 comprising a second knit structure 3320, the textile of the rear strap 3305 may be more stretchable than the textile material of the side strap 3301, Paragraph 0369 and Figure 55), the at least one second area being configured to extend over a rear portion of the patient's head in use (rear strap 3305 comprising second knit structure 3320 extends over the rear of the patients head, Figure 55), wherein the second knit structure is different than the first knit structure, and the at least one second area has increased stretchability as compared to the first area due to at least partially the different knit structures (different textile materials are used for that of the side straps 3301 and rear strap 3305, with the textile material of the rear strap 3305 being more stretchable than the textile material of the side strap 3301, Paragraph 0369 and Figure 55).
However, Baigent doesn’t explicitly wherein the positioning and stabilizing structure comprises a one-piece knitted headgear strap of a single piece of material; and although Baigent teaches varying first and second textile/knit structures that correspond to varying stretchability among the headgear straps (Paragraph 0369, Figure 55), Baigent doesn’t explicitly state wherein the second knit structure is a rib knit structure.
However, Scheiner teaches a respiratory headgear assembly (Abstract and Figure 39) comprising a headgear strap (strap 3301 comprising side straps 3315, 3316, and back strap 3317, Figure 65 and Paragraph 0475) wherein the headgear strap is made from a single piece of material (strap 3301 is a 3D knitted fabric that is knit by computer control as a single unitary piece, Paragraph 0475), further teaching wherein the headgear strap has different areas of different knit structures and stretchability (variation in the thread and stitching may occur at various positions along the strap 3301 to adjust the elasticity, strength and durability of the strap at certain locations, Paragraph 0475 and Figures 65-66).
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 Baigent’s headgear assembly by having the headgear strap be made from a single piece of unitary material, while still having a first and second area of varying stretchability, as taught by Scheiner, as forming the headgear strap from a single piece of material may reduce manufacturing costs by reducing the number of materials used, while having varying stretchability at certain locations along the strap allows the strap to be adjusted as needed to better fit the user’s head.
Regarding the second knit structure being a rib knit structure, Scott teaches a patient interface device (Abstract, Figure 1) comprising a headgear assembly (head positioning aid 100, Paragraph 0053 and Figures 1-4) comprising a strap portion extending over a rear portion of the patient’s head (headgear member 110, Paragraph 0076 and Figures 1-4), wherein the strap comprises a rib knit structure (headwear member 110 may comprise a stretchable, ribbed knit material, Paragraph 0074).
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 Baigent’s second knitted structure by having it comprise a rib knitted structure, as taught by Scott, as using a rib knitted material in the rear portion of a headgear assembly provides a flexible, stretchable, breathable and comfortable material for the patient’s head while in use.
Regarding claim 2, Baigent in view of Scheiner and Scott teach the patient interface of claim 1, with Baigent further teaching wherein the at least one second area comprises 1) an upper portion configured to extend above the otobasion superior of the patient's head in use (rear strap 3301 comprising second knit structure 3320 extending above the otobasion superior of the patient’s head in sure, Figure 55), however the embodiment shown in Figure 55 is silent on a lower portion configured to extend below the otobasion inferior of the patient's head in use.
However, Baigent teaches an alternative embodiment of the positioning and stabilizing structure 3300 in Figure 28 comprising a strap with a portion configured to extend below the otobasion inferior of the patient’s head in use (see lower portion of strap 3301 extending bellowing the otobasion inferior of the patients head, Figure 28 and Paragraph 0367).
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 the embodiment of Baigent shown in Figure 55 by including a lower portion of a strap extending below the otobasion inferior of the patient’s head, as taught by the embodiment as shown in Figure 28 of Baigent, as providing an additional strap around beneath the bottom of the user’s ear may assist in providing a more secure and better fitting headgear assembly.
Regarding claim 3, Baigent in view of Scheiner and Scott teach the patient interface of claim 1, however the embodiment of Baigent shown in Figure 55 is silent on wherein the at least one first area includes a neck strap portion configured to overlay the occipital bone of the patient's head and/or lie against the patient's neck in use, and wherein the neck strap portion has increased rigidity as compared to the at least one second area.
However, Baigent teaches an alternative embodiment of the positioning and stabilizing structure 3300 in Figure 28 comprising a neck strap portion configured to overlay the occipital bone of the patients head and/or lie against the patient’s neck in use (see bottom portion of the strap 3301 extending across occipital bone and against user’s neck in use, Figure 28) wherein the neck strap portion has increased rigidity as compared to the rear strap (the textile of the rear strap 3305 may be more stretchable than the textile materials of the side straps 3301 and crown strap 3307, Paragraph 0369).
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 the embodiment of Baigent shown in Figure 55 by including a neck strap extending against the neck of the user, as taught by the embodiment as shown in Figure 28 of Baigent, as providing an additional strap extending around the user’s neck may assist in providing a more secure and better fitting headgear assembly.
Regarding claim 4, Baigent in view of Scheiner and Scott teach the patient interface of claim 1, with Baigent further teaching wherein the at least one first area (see strap 3311 comprising a first area comprised of a first knit structure 3316, Paragraph 0424 and Figure 55) comprises a front portion of the headgear strap configured to interface with the cushion assembly (see first knit structure 3316 comprising a front portion configured to interface with cushion assembly 3100, Figure 55), wherein the front portion has increased rigidity as compared to the at least one second area (the textile of the rear strap 3305 may be more stretchable than the textile materials of the side straps 3301, therefore the front portion of the side strap 3301 has increased rigidity as compared to the rear strap 3305 comprising material 3320, Paragraph 0369 and Figure 30).
Regarding claim 6, Baigent in view of Scheiner and Scott teach the patient interface of claim 1, with Baigent further teaching wherein the first knit structure of the at least one first area has increased rigidity as compared to the second rib knit structure (the textile of the rear strap 3305 may be more stretchable than the textile materials of the side straps 3301 and crown strap 3307, therefore the side straps 3301 and crown strap 3307 have increased rigidity as compared to the more stretchable rear strap 3305, Paragraph 0369 and Figure 30).
Regarding claim 7, Baigent in view of Scheiner and Scott teach the patient interface of claim 1, with Baigent further teaching wherein the first knit structure of the at least one first area is an interlock knit structure (straps may be made by 3D knitting techniques, therefore the side straps 3301 and crown strap 3307 form an interlocking knit structure, Paragraph 0291).
Regarding claim 8, Baigent discloses the patient interface of claim 1, however the embodiment shown in Figure 30 is silent on further comprising at least one third area having a third knit structure, the at least one third area having increased stretchability as compared to the at least one first area and reduced stretchability as compared to the at least one second area.
However, Baigent teaches an alternative embodiment of the positioning and stabilizing structure (Figure 24 ad Paragraph 0363) comprising a plurality of straps (side straps 3301, cheek straps 3304, rear straps 3305, and crown strap 3307, Figure 24), wherein at least one of the straps comprises at least one third area having a third knit structure, the at least third area having increased stretchability as compared to the at least one first area and reduced stretchability as compared to the at least one second area (each strap 3301, 3304, 3305, and 3307 may be made from a different textile material to provide a unique function and/or stretch that corresponds to the portion of the patient’s head which it engages, therefore Baigent’s device is fully capable of providing three straps with three distinct knit structures with varying stretchability, Paragraph 0363).
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 the embodiment of Baigent shown in Figure 30 by including a third area of the straps having a third knit structure, as taught by the embodiment as shown in Figure 24 and Paragraph 0363 of Baigent, as providing a plurality of straps made of different textile materials, and therefore their own degree of stretchability corresponding to the portion of the patient’s head with which it engages, would therefore provide a more customizable headgear assembly with varying degrees of stretchability.
Regarding claim 9, Baigent further teaches wherein the at least one third area comprises a first section therewithin having a fourth mesh knit structure forming at least one ventilation area (vented structure 3400 made of a space fabric mesh, Figure 29A and Paragraph 0368), and wherein the third knit structure is a different knit structure than the fourth mesh knit structure (vented structure 3400 may of a space fabric mesh, whereas the straps are textile, therefore comprise different knitted compositions).
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 the embodiment of Baigent shown in Figure 30 by including a mesh knit structure forming at least one ventilation area, as taught by the embodiment shown in Figure 29A and Paragraph 0368 of Baigent, as providing such a ventilation area in the form a mesh allows for the washout of exhaled gases (Paragraph 0425 of Baigent).
Regarding claim 11, Baigent in view of Scheiner teach the patient interface of claim 1, with Baigent further teaching wherein the at least one first area comprises a front portion having an aperture to receive an air delivery tube connector (see side strap 3301 comprising first knit structure 3316 comprising a front portion having an aperture to receive air delivery tube 4170 connection, Figure 55).
Regarding claim 12, the embodiment shown in Figure 28 of Baigent further teaches wherein the upper portion and the lower portion include respective strap ends that are configured to attach to the cushion assembly (see upper and lower portions of strap 3301 comprising respective strap end connectors 3315 to thereby attach to cushion assembly, Figure 28 and Paragraph 0367).
Regarding claim 72, Baigent’s embodiment as shown in Figure 24 further teaches wherein the at least one first area forms a front portion of the headgear strap configured to interface with the cushion assembly (see side strap 3301 extending overing the sealing cushion structure 3100, Figure 24), wherein the at least one second area forms a rear portion of the headgear strap (rear strap 3305, Figure 24), and wherein the at least one third area forms an intermediate portion of the headgear strap between the front portion and the rear portion (cheek strap 3304 forms an intermediate portion of the headgear strap between the front and rear portion, Figure 24).
Regarding claim 73, Baigent’s embodiment as shown in Figure 24 further teaches wherein the intermediate portion is configured to, in use, extend along respective sides of the patient's face between the patient's eye and ear (see cheek strap 3304 extending along respective sides of the patent’s face between the patient’s eye and ear, Figure 24).
Regarding claim 74, Baigent’s embodiment as shown in Figure 29A further teaches the intermediate portion has at least one section with a mesh knit structure forming at least one ventilation area (vented structure 3400 may of a space fabric mesh, whereas the straps are textile, therefore comprise different knitted compositions).
Regarding claim 75, Baigent’s embodiment as shown in Figure 24 further teaches wherein the intermediate portion has a different textile composition than the front portion thereby providing the intermediate portion with increased stretchability as compared to the front portion (each strap 3301, 3304, 3305, and 3307 may be made from a different textile material to provide a unique function and/or stretch that corresponds to the portion of the patient’s head which it engages, therefore Baigent’s device is fully capable of providing the intermediate cheek strap 3304 with a different textile composition than that of the side strap 3301 and rear strap 3305 with varying stretchability).
Regarding claim 76, Baigent in view of Scheiner and Scott teach the patient interface of claim 1, with Baigent further teaching wherein the headgear strap is configured to form a closed loop around the patient's head, in use, extending across the cushion assembly, along respective sides of the patient's head, and across a rear portion of the patient's head (see straps 3301, 3305 and 3307 forming a closed loop around the patients head, with strap 3301 extending across the cushion assembly and along the sides of the patients head, and strap 3305 extending across a rear portion of the patient’s head, Figure 55).
Regarding claim 77, Baigent discloses the patient interface of claim 1, however the embodiment shown in Figure 55 is silent wherein the cushion assembly is an oro-nasal cushion assembly.
However, Baigent teaches an alternative embodiment of the sealing cushion (Figure 11A-11B and Paragraph 0316) wherein the cushion assembly is an oro-nasal cushion assembly (seal forming structure 3100 provided with openings to seal with nares and the mouth of the patient, Paragraph 0316 and Figure 11C).
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 the embodiment of Baigent shown in Figure 30 by having the cushion assembly be an oro-nasal cushion assembly, as taught by the embodiment shown in Figure 11C of Baigent, as providing a cushion assembly covering both the patients mouth and nose may aide in the delivery of oxygen towards the patients airways.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Baigent (WO 2016/082001 A1) in view of Scheiner et al. (US 2015/0342306 A1), Scott et al. (US 2018/0221191 A1) and in further view of Hammer et al. (US 2017/0182276 A1).
Regarding claim 5, Baigent in view of Scheiner and Scott teach the patient interface of claim 1, and although Baigent further teaches the first area being more rigid as compared to the at least one second area (the textile of the rear strap 3305 may be more stretchable than the textile materials of the side straps 3301 and crown strap 3307, therefore the side straps 3301 and crown strap 3307 have increased rigidity as compared to the more stretchable rear strap 3305, Paragraph 0369 and Figure 30), Baigent doesn’t explicitly state wherein the at least one first area includes a rigidizing yarn that is rigidized to provide the at least one first area with increased rigidity as compared to the at least one second area.
However, Hammer teaches a patient interface headgear assembly (Abstract and Figure 1) comprising a at least one first area (region 1026, Paragraph 0096 and Figure 6) and at least one second area (region 1024, Figure 6 and Paragraph 0096) wherein the first area includes a rigidizing yarn to provide the first area with increased rigidity as compared to the second area (region 1026 may be provided with a more rigid yarn, therefore having increased rigidity than that of region 1024).
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 Baigent’s device by including a rigidizing yarn in the at least one first area, provides an effectives means of rigidizing a portion of the headgear assembly to allow for customizable stretching characteristics of the overall device.
Claims 10 and 78 are rejected under 35 U.S.C. 103 as being unpatentable over Baigent (WO 2016/082001 A1) in view of view of Scheiner et al. (US 2015/0342306 A1), Scott et al. (US 2018/0221191 A1) and in further view of Collins et al. (US 2019/0374737 A1).
Regarding claim 10, Baigent in view of Scheiner and Scott teach the patient interface of claim 8, however doesn’t explicitly state wherein the at least one third area has a tubular form.
However, Collins teaches a patient interface assembly (Abstract and Figure 1) comprising a headgear with a plurality of straps that have a tubular form (front strap 150, crown strap 160 and rear strap 170 are tubular, Figure 1 and Paragraph 0155).
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 Baigent’s device by having all of the straps, including the third area, to have a tubular form, as providing headgear straps with tubular and/or rounded edges may provide the user with greater comfort when using the device.
Regarding claim 78, Baigent further discloses wherein the at least one first area forms a front portion of the headgear strap configured to interface with the cushion assembly (see side strap 3301 extending over cushion assembly 3100, Figure 30), wherein the at least one second area forms a rear portion of the headgear strap (rear strap 3305, Figure 30), wherein the headgear strap is configured to form a closed loop around the patient's head, in use, extending across the cushion assembly, along respective sides of the patient's head, and across a rear portion of the patient's head (see headgear straps forming closed loop around patient’s head, with strap 3301 extending across the cushion assembly 3100 and sides of the patient’s head, and strap 3305 extending across rear portion, Figure 30).
However, the embodiment of Baigent as shown in Figure 30 is silent wherein the at least one third area forms an intermediate portion of the headgear strap between the front portion and the rear portion, wherein the intermediate portion is configured to, in use, extend along respective sides of the patient's face between the patient's eye and ear, wherein the intermediate portion has at least one section with a mesh knit structure forming at least one ventilation area, wherein the front portion has increased rigidity as compared to the intermediate portion, and wherein the intermediate portion has a tubular form.
However, Baigent teaches an embodiment as shown in Figure 24 wherein the at least one third area forms an intermediate portion of the headgear strap between the front portion and the rear portion (cheek strap 3304 forms an intermediate portion of the headgear strap between the front and rear portion, Figure 24) wherein the intermediate portion is configured to, in use, extend along respective sides of the patient's face between the patient's eye and ear (see cheek strap 3304 extending along respective sides of the patent’s face between the patient’s eye and ear, Figure 24), wherein the intermediate portion has at least one section with a mesh knit structure forming at least one ventilation area (vented structure 3400 may of a space fabric mesh, whereas the straps are textile, therefore comprise different knitted compositions) wherein the front portion has increased rigidity as compared to the intermediate portion (each strap 3301, 3304, 3305, and 3307 may be made from a different textile material to provide a unique function and/or stretch that corresponds to the portion of the patient’s head which it engages, therefore Baigent’s device is fully capable of providing the intermediate cheek strap 3304 with a different textile composition than that of the side strap 3301 and rear strap 3305 with varying stretchability).
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 the embodiment of Baigent shown in Figure 30 by including an intermediate area between the front and rear straps, as taught by the embodiment as shown in Figure 24 and Paragraph 0363 of Baigent, as providing a plurality of straps made of different textile materials, and therefore their own degree of stretchability corresponding to the portion of the patient’s head with which it engages, would therefore provide a more customizable headgear assembly with varying degrees of stretchability.
In regards to the intermediate portion of the strap being of tubular form, Collins teaches a patient interface assembly (Abstract and Figure 1) comprising a headgear with a plurality of straps that have a tubular form (front strap 150, crown strap 160 and rear strap 170 are tubular, Figure 1 and Paragraph 0155).
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 Baigent’s device by having all of the straps, including the intermediate portion, to have a tubular form, as providing headgear straps with tubular and/or rounded edges may provide the user with greater comfort when using the device.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Baigent (WO 2016/082001 A1) in view of view of Scheiner et al. (US 2015/0342306 A1), Scott et al. (US 2018/0221191 A1) and in further view of the NPL Document (Questions about ribbing sewing discussion topic @ PatternReview.com).
Regarding claim 13, Baigent in view of Scheiner and Scott teach the patient interface of claim 1, and although Scott teaches a rib knitted structure being used in a strap portion extending over the rear portion of the patient’s head, Scott doesn’t explicitly state the rib knit structure being a 1x1, 2x2, 3x3, or 1x2 rib knit structure.
However, the NPL document teaches 1x1, 2x2, 3x3 or 1x2 rib knit structures are common rib knitting stitches used to make comfortable, stretchable rib knitted materials (Page 2 of NPL Document).
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 Baigent’s device by having the second knitted structure be a 1x1, 2x2, 3x3, or 1x2 rib knit structure, as providing a rib knitted material provides comfort and stretchability to the material, with 1x1, 2x2, 3x3, or 1x2 rib knit structures being art-recognized rib-knit stitching techniques.
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
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