DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
This Office Action is in response to the amendment filed on 02/02/2026. Claims 1, 3-7, 9-10, 12, 15-20, 22, and 24 are amended. Claims 2, 8, 11, 13-14, 21, 23, and 25 are as previously presented. Claims 26-98 are canceled. Claims 99-101 are new. As such claims 1-25 and 99-101 are pending in the instant application.
All objections and rejections pursuant of 35 U.S.C. 112(b) are withdrawn in light of the amendments.
Claim Objections
Claims 1, 5, 15, and 101 are objected to because of the following informalities:
Claim 1, line 7: “the patient’s frontal bone” should read “a frontal bone of the patient” to establish antecedent basis.
Claim 1, line 20: “the patient’s cheeks” should read “cheeks of the patient” to establish antecedent basis.
Claim 5, line 7: “the patient’s parietal bone” should read “a parietal bone of the patient” to establish antecedent basis.
Claim 15, line 2: “said the first” should read “the first” for clarity.
Claim 101, line 2: “a plenum chamber pressurisable to a therapeutic pressure” should read “a plenum chamber configured to be pressurized to a therapeutic pressure” for clarity.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 4-6 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 4 recites the limitation "the rear section of the headband" in line 2. There is insufficient antecedent basis for this limitation in the claim. It is unclear if the limitation is drawn to the rear section of the positioning and stabilizing structure as recited in claim 1 (line 3), or if Applicant is trying to disclose a new limitation of a rear section of a headband. For the purpose of examination, the above limitation will be interpreted as – the rear section of the positioning and stabilizing structure – as recited in claim 1 (line 3).
Claims 5-6 are rejected as they depend from a rejected claim.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-7 and 9-14 are rejected under 35 U.S.C. 103 as being unpatentable over Rummery et al. (US 20100229868 A1; hereinafter “Rummery”) in view of McLaren et al. (US 11986595 B2; hereinafter “McLaren”), and in further view of Sims et al. (WO 2019003094 A1; hereinafter “Gareth”).
Regarding claim 1, Rummery discloses a positioning and stabilising structure (36; Fig. 14a) for a patient interface (32; Fig. 14a), comprising:
a front section (38, 68, 68a. 68b; Fig. 14a) and a rear section (40 and 42; Fig. 14a) forming a continuous loop of material (38 connects 40 to 42 to form a continuous loop of material around the crown of the patient’s head, see Figs. 14a and 14b), the front section (38, 68, 68a. 68b; Fig. 14a) forming a first bifurcated section (68, 68a, 68b; Fig. 14a) with a first front part (68a; Fig. 14a) and a second front part (68b; Fig. 14a);
an upper textile portion (40 and 68a; Fig. 14a) comprising a resilient circumferential band ([0135], lines 12-14; [0138], lines 3-6; Figs. 14a and 14b; EXAMNINER NOTE: [0236] of Applicant’s specification recites “one or more resilient straps extending therefrom to engage with a harness that retains the seal-forming structure in place”, hence straps 40, 38, 68, 68a, and 68b of Rummery are resilient) for fitting to a patient's head in use (Fig. 14a; [0134], lines 10-13), the upper textile portion (40 and 68a; Fig. 14a) formed from the rear section (40; Fig. 14a) and from the first front part (68a; Fig. 14a); and
at least one lower textile portion (68b; Fig. 14a) including a first lower textile portion (68b; Fig. 14a) formed from the second front part (68b; Fig. 14a);
wherein the first lower textile portion (68b; Fig. 14a) is stretchable relative to the upper textile portion (40 and 68a; [0218], lines 3-4, where 68 is formed of soft flexible material, hence 68b is capable of stretching relative to 40 and 68a), and is constructed and arranged to provide a force to hold a seal-forming structure of the patient interface in a therapeutically effective position on the patient's head ([0219]; [0138], lines 1-6, where 68b is included in 68 and 38, see Fig. 14a), and
wherein the first lower textile portion (68b; Fig. 14a) is configured to be proximate to the first front part (68a; Fig. 14a; [0222], lines 5-7, where if the length of 68a and 68b is substantially equal, 68b would be located proximally to 68a), and the first lower textile portion (68b; Fig. 14a) is configured to be distal to the first front part and overlay the patient’s cheeks in a second position (68a; Fig. 14a; [0222], lines 5-7, where if the length of 68a and 68b is substantially different, 68b would be located distally from 68a) and overlay the patient's cheeks in the second position (68b lays over the cheek of patient 1 in Fig. 14a).
While Rummery does disclose the at least one lower textile portion (68b; Fig. 14a) being stretchable relative to the upper textile portion (40 and 68a; [0218], lines 3-4; see claim 1 above), Rummery fails to explicitly disclose the upper textile portion (40 and 68a; Fig. 14a) being configured to overlay at least the patient’s frontal bone in use; at least one lower textile portion (68b; Fig. 14a) being movably connected to the upper textile portion (40 and 68a; Fig. 14a); wherein, when the positioning and stabilising structure is worn by the patient, the first lower textile portion is configured to be movable between a first position and a second position.
However, McLaren teaches an analogous mask interface (102; Figs. 13a and 13b) that can rest on a user’s forehead (Fig. 13a), where the side straps (204; Fig. 13a) are elastic (Col. 5, line 45, where the side straps are lower side straps 204) and moveably connected to a top strap (206; Fig. 13b) and a rear section (208; Fig. 13a).
Therefore, it would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the upper textile portion (40 and 68a; Fig. 14a) and the stretchable first lower textile portion (68b; Fig. 14a), as taught by Rummery, with the elastic material of the side straps, as taught by McLaren (see McLaren Figs. 13a-13b and col. 5, line 45), such that the upper textile portion (40 and 68a; Fig. 14a) is capable overlaying at least the patient’s frontal bone in use (see McLaren Fig. 13a), and the at least one lower textile portion (68b; Fig. 14a) is movably connected to the upper textile portion (40 and 68a; Fig. 14a; see McLaren Figs. 13a-13b, where elastic side straps 204 are movably connected to top strap 206 and rear section 208) to improve user comfort when removing the patient interface or putting the patient interface on for use (McLaren: Col. 19, lines 65-67; Col. 20, lines 1-6).
As such, the first lower textile portion (68b; Fig. 14a), taught by Rummery as modified by McLaren above, would be capable of moving between a first position and a second position when the positioning and stabilizing structure is being worn by the patient (depicted in McLaren Figs. 13a-13b).
Rummery, as modified by McLaren, fails to explicitly teach the first lower textile portion (68b; Fig. 14a) is configured to overlay the patient’s frontal bone in the first position when the positioning and stabilising structure is not connected to the patient interface.
However, Gareth teaches an analogous headgear assembly (2200) with a yoke (2202) that is received by a recessed region of a mask interface (2102 and 2106; Fig. 74), where the yoke (2202) retains a seal retention band (2300; Fig. 74).
Therefore, it would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the patient interface (32; Fig. 14a), as taught by Rummery, with the mask interface (2102 and 2106; Fig. 74) taught by Gareth, to removably attach the first lower textile portion (68b; Fig. 14a) to the patient interface (68b of Rummery is received by the yoke 2202 of Gareth, where Gareth’s yoke 2202 is received by a recessed region of Gareth’s mask interface 2102 and 2106; see Gareth Fig. 74; pg. 3, lines 25-27), such that the first lower textile portion (68b; Fig. 14a) is capable of overlaying the patient’s frontal bone in the first position (see McLaren Fig. 13a) when the positioning and stabilising structure is not connected to the patient interface to improve comfort for a user and facilitate the process of donning and doffing the positioning and stabilizing structure.
Regarding claim 2, Rummery as modified teaches the invention as set forth in claim 1, wherein the first lower textile portion (68b; Fig. 14a) is integral with the upper textile portion (40 and 68a; see Fig. 14a, where 68b is the same piece of fabric as 40 and 68a).
Regarding claim 3, Rummery as modified teaches the invention as set forth in claim 1, wherein the positioning and stabilising structure (36; Fig. 14a) is in the form of a headband (see 36 of Figs. 14a and 14b).
Regarding claim 4, Rummery as modified teaches the invention as set forth in claim 1, wherein the rear section (40 and 42; Fig. 14a) of the headband (see 36 of Figs. 14a and 14b) comprises a second bifurcated section (40 and 42; Fig. 14a) comprising a first rear part (40; Fig. 14a) and a second rear part (42; Fig. 14a),
wherein the first rear part (40; Fig. 14a) forms part of the upper textile portion (40 is part of upper textile portion formed by 40 and 68a, see claim 1 above; Fig. 14a) and the second rear part (42; Fig. 14a) forms a second lower textile portion (42; Fig. 14a).
Regarding claim 5, Rummery as modified teaches the invention as set forth in claim 4, wherein the rear section (40 and 42; Fig. 14a) comprises the first rear part (40; Fig. 14a) and the second lower textile portion (42; see Fig. 14a),
wherein, in use, the first rear part (40; Fig. 14a) and the second lower textile portion (42; Fig. 14a) are configured to overlay the patient's occipital bone in the first position of the positioning and stabilizing structure (14a; McLaren: Fig. 13a, where the position of 208 and 206 is overlayed relative to the occipital bone of the patient), and
wherein, in use, the first rear part (40; Fig. 14a) is movable away from the second lower textile portion (42; Fig. 14a; [0216], lines 2-3) to overlay the parietal bone in the second position of the positioning and stabilizing structure (Fig. 14a; [0216], lines 2-3; [0221], lines 5-7, where the adjustment in length of 40 allows 40 to be positioned over the parietal bone of the patient).
Regarding claim 6, Rummery as modified teaches the invention as set forth in claim 5, wherein the front section (38, 68, 68a. 68b; Fig. 14a) and the rear section (40 and 42; Fig. 14a) combine to form an X-shape in the second position of the positioning and stabilizing structure (see Annotated Fig. 14a below).
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Annotated Fig. 14a
Regarding claim 7, Rummery as modified teaches the invention as set forth in claim 1, wherein the first lower textile portion (68b; Fig. 14a) is a seal retention band (68b provides force to hold seal-forming structure of patient interface in place, see claim 1) that is resiliently (EXAMNINER NOTE: [0236] of Applicant’s specification recites “one or more resilient straps extending therefrom to engage with a harness that retains the seal-forming structure in place”, hence straps 40, 38, 68, 68a, and 68b of Rummery are resilient) stretchable along at least part of its length ([0218], lines 3-4, where 68 is formed of soft flexible material, hence 68b is capable of stretching), and is configured to, in use, engage with an outer surface of the patient interface to hold the seal- forming structure in the therapeutically effective position (Fig. 14a; see claim 1 above).
Regarding claim 9, Rummery as modified teaches the invention as set forth in claim 7, wherein the seal retention band (68b provides force to hold seal-forming structure of patient interface in place, see claim 1; Fig. 14a) is configured to be received in a channel of the patient interface (68b of Rummery is received by the yoke 2202 of Gareth, where Gareth’s yoke 2202 is received by a recessed region of Gareth’s mask interface 2102 and 2106; see Gareth Fig. 74).
Regarding claim 10, Rummery as modified teaches the invention as set forth in claim 9, wherein the channel of the patient interface (Gareth: channel within yoke 2202, where the yoke 2202 is received by a recessed region of Gareth’s mask interface 2102 and 2106; Fig. 74) is formed in a plenum chamber (Gareth: where the yoke 2202 and the recess to receive yoke 2202 are formed in the mask interface 2102 and 2106; EXAMINER NOTE: [0068] of Applicant’s specification recites “a patient interface, e.g., the plenum chamber”, hence the channel within yoke 2202 and the recess to receive yoke 2202 being formed in the mask interface 2102 and 2106 reads on the limitation of claim 10) of the patient interface (32; Fig. 14a).
Regarding claim 11, Rummery as modified teaches the invention as set forth in claim 7, wherein the seal retention band (edge of 68b, where 68b provides force to hold seal-forming structure of patient interface in place, see claim 1; Fig. 14a) comprises a port (connection port between swivel neck 17 and patient interface structure 32, where the edge of 68b comprises said connection port) for coupling the seal-forming structure (seal of patient interface structure 32) to an air circuit for supplying pressurised air to the patient ([0221], lines 12-16; [0212], last sentence of paragraph).
Regarding claim 12, Rummery as modified teaches the invention as set forth in claim 1, wherein said first lower textile portion (68b; Fig. 14a) comprises a pair of lower textile portions (pair of 68b, where a strap 68b is provided on both the left and right side of the patient interface 32) configured to couple to each other, and/or to an intermediate structure (Rummery right side 68b and left side 68b are coupled to Garth yoke 2202, where Garth yoke 2202 is coupled to Garth frame 2106, see claims 9 and 10 above), to provide the force to hold the seal-forming structure of the patient interface in a therapeutically effective position on the patient’s head (68b provides force to hold seal-forming structure of patient interface in place, see claim 1; Fig. 14a).
Regarding claim 13, Rummery as modified teaches the invention as set forth in claim 12, wherein the intermediate structure (Garth: yoke 2202 and frame 2106) is a harness (see Garth Fig. 74) that, in use, retains the seal-forming structure in the therapeutically effective position (Garth yoke 2202 and frame 2106 retains Rummery patient interface 32 in a therapeutically effective position via Rummery 68b, see claims 1 and 12 above).
Regarding claim 14, Rummery as modified teaches the invention as set forth in claim 12, wherein the intermediate structure (Garth: yoke 2202 and frame 2106) comprises the seal- forming structure (Garth yoke 2202 and frame 2106 retains Rummery patient interface 32 in a therapeutically effective position via Rummery 68b, see claims 1 and 12 above), or part thereof.
Claims 8, 15, and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Rummery (US 20100229868 A1) in view of McLaren (US 11986595 B2) in view of Gareth (WO 2019003094 A1) as applied to claims 1 and 7 above, and further in view of Huddart et al. (US 20160074614 A1; hereinafter “Huddart”).
Regarding claim 8, Rummery as modified teaches the invention as set forth in claim 7, but is silent to the seal retention band (68b provides force to hold seal-forming structure of patient interface in place, see claim 1; Fig. 14a) is more stretchable than the upper textile portion.
However, Huddart teaches a headgear configuration (10100), where the rear portion (10122) is more rigid than the frontal portion (10124; [0466], lines 14-18), hence the frontal portion (10124) is more elastic than the rear portion (10122).
Therefore, it would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the straps 68b and 40 of Rummery with the material and elasticity characteristics of straps 10122 and 10124 of Huddart such that the seal retention band (68b provides force to hold seal-forming structure of patient interface in place, see claim 1; Fig. 14a) is more stretchable than the upper textile portion (Huddart: [0466], lines 14-18, where the straps 68b and 40 of Rummery have the same material and elasticity characteristics of straps 10122 and 10124 of Huddart) to allow the positioning and stabilising structure to stretch such that the positioning and stabilising structure may be placed on a patient’s face for use (Huddart: [0466], lines 16-18).
Regarding claim 15, Rummery as modified teaches the invention as set forth in claim 1, but is silent to wherein said the first lower textile portion (68b; Fig. 14a) comprises one or more rigidized sections.
However, Huddart teaches a textile portion (10122 and 10124; Fig. 127a) can have different constructions, where the rear portion (10122; Fig. 127a) may be more rigid than the frontal portion (10124; Fig. 127a; [0466], lines 12-14).
Therefore, it would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the first lower textile portion (68b; Fig. 14a) of Rummery with the construction of the textile portion (10122 and 10124; Fig. 127a) taught by Huddart such that said the first lower textile portion (68b; Fig. 14a) comprises one or more rigidized sections (Huddart: Fig. 127a; [0466], lines 12-14) to provide a retention force to the patient interface and allow the positioning and stabilizing structure to be placed on the patient’s face (Huddart: [0466], lines 16-18).
Regarding claim 16, Rummery as modified teaches the invention as set forth in claim 15, but fails to explicitly teach the first lower textile portion (68b; Fig. 14a) has a higher rigidity in an intermediate section (42; Fig. 14a) thereof than at end portions thereof (left side 68b and right side 68b; Fig. 14a; see claim 15 above, where 48 is more rigid than 68b).
However, Huddart teaches straps (5502, 5504, 5506, 5508, 5510; Fig. 21) of a headgear (5500; Fig. 21) with a core (5512; Figs. 22A-22E) and a cover layer (5514; Figs. 22A-22E), where the core (5512) provides a foundation for the overall structure of the headgear (third sentence of [0342]). Huddart further teaches the cover layer (5514) and core (5512) can be provided with an amount of elasticity, and that the cross sectional dimensions of various headgear portions can be varied along a length of said portions to provide additional structure in some portions of the headgear and increased elasticity in other portions of the headgear ([0342]).
Therefore, it would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify further modify at least the first lower textile portion (68b; Fig. 14a), as taught by Rummery, with the above core and cover layer strap configuration, as taught by Huddart, such that an intermediate section of the first lower textile portion (68b; Fig. 14a) has a higher rigidity compared to its ends (Huddart [0342]) to improve the performance of the headgear at particular locations and/or sections (Huddart [0342], lines 29-31).
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Rummery (US 20100229868 A1) in view of McLaren (US 11986595 B2) in view of Gareth (WO 2019003094 A1) as applied to claim 1 above, and further in view of Togliatti (US 20200142434 A1).
Regarding claim 17, Rummery as modified teaches the invention as set forth in claim 1, but is silent to comprising at least one sensor provided in or on the upper textile portion and/or the at least one lower textile portion.
However, Togliatti teaches one or more sensors (306; Fig. 3) in headgear (305; [0028], lines 4-6) of a CPAP system (300; Fig. 3), where the one or more sensors (306; Fig. 3) are disposed in a strap of the headgear (see position of 306a and 306b in headgear 305; Figs. 3 and 4a; [0028], lines 5-6; [0019], lines 1-3, where the one or more sensors are the one or more sensors 306).
Therefore, it would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the side straps (38, 68, 68a, and 68b; Fig. 14a) of Rummery to include the sensors (306a and 306b; Fig. 3) of Togliatti such that at least one sensor (Togliatti: 306a and 306b; Fig. 3) provided in or on the upper textile portion and/or the at least one lower textile portion (Togliatti sensors 306a and 306b are provided on Rummery side straps 38, 68, 68a, and 68b) to prevent triggering a shutoff or deactivation of air supply to a patient as a result of tension increases in the headgear due to body movement during treatment (Togliatti: [0027], lines 12-14).
Claims 18-20 and 22-23 are rejected under 35 U.S.C. 103 as being unpatentable over Rummery (US 20100229868 A1) in view of McLaren (US 11986595 B2) in view of Gareth (WO 2019003094 A1) in view of Togliatti (US 20200142434 A1) as applied to claim 17 above, and in further view of McLaren & Hammer (US 20150283349 A1).
Regarding claim 18, Rummery as modified teaches the invention as set forth in claim 17, but is silent to comprising at least one actuator provided in or on the upper textile portion and/or the at least one lower textile portion.
However, McLaren & Hammer teaches an actuator located in headgear for a patient interface ([0206], lines 14-15).
Therefore, it would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to further modify Rummery with the above teachings of McLaren & Hammer such that at least one actuator (McLaren & Hammer: actuator; [0206], lines 14-15) provided in or on the upper textile portion and/or the at least one lower textile portion (McLaren & Hammer: [0206], lines 14-15, where the headgear is the positioning and stabilising structure 36 of Rummery) to improve operation of the respiratory therapy device due to the monitorization and adjustment functions of an actuator (McLaren & Hammer: [0206], lines 17-18).
Regarding claim 19, Rummery as modified teaches the invention as set forth in claim 18, wherein the at least one sensor (Togliatti: 306a and 306b; Fig. 3) and/or the at least one actuator is partly exposed to ambient environment at an exterior surface of the upper textile portion or at an exterior surface of the at least one lower textile portion; and/or is partly exposed at a patient-contacting surface of the upper textile portion or the one or at a patient-contacting surface of the at least one lower textile portion (Togliatti sensors 306a and 306b are provided on Rummery side straps 38, 68, 68a, and 68b), so as to contact skin of the patient in use (Togliatti: [0019], lines 1-3, where the one or more sensors are the one or more sensors 306, hence the one or more sensors 306 are in contact with a surface of Rummery side straps 38, 68, 68a, and 68b which are in contact with the skin of the patient during use).
Regarding claim 20, Rummery as modified teaches the invention as set forth in claim 18, wherein the at least one sensor (Togliatti: 306a and 306b; Fig. 3) and/or the at least one actuator is at least partly embedded between an outer layer of the upper textile portion and a patient-contacting layer of the upper textile portion, or between an outer layer of the at least one lower textile portion and a patient-contacting layer of the at least one lower textile portion (Togliatti: [0019], lines 1-3, where the one or more sensors are the one or more sensors 306, hence the one or more sensors 306 are embedded in between an outer layer of Rummery side straps 38, 68, 68a, and 68b and a surface of Rummery side straps 38, 68, 68a, and 68b which are in contact with the skin of the patient during use).
Regarding claim 22, Rummery as modified teaches the invention as set forth in claim 18, comprising at least one sensor-retaining structure (38, 68, 68a, and 68b) for a respective attachment of the at least one sensor (Togliatti: 306a and 306b; [0019], lines 1-3, where the one or more sensors are the one or more sensors 306, hence the one or more sensors 306 are embedded in between an outer layer of Rummery side straps 38, 68, 68a, and 68b and a patient-contacting surface of Rummery side straps 38, 68, 68a, and 68b to retain the one or more sensors 306 for attachment) and/or the at least one actuator.
Regarding claim 23, Rummery as modified teaches the invention as set forth in claim 22, wherein the at least one sensor-retaining structure (38, 68, 68a, and 68b) comprises at least one pocket (Togliatti: [0019], lines 1-3, hence the one or more sensors 306 are embedded in a pocket formed from an outer layer of Rummery side straps 38, 68, 68a, and 68b and a patient-contacting surface of Rummery side straps 38, 68, 68a, and 68b; see claim 22 above) to accommodate the at least one sensor (Togliatti: [0019], lines 1-3, where the one or more sensors 306 are disposed in the pocket formed by an outer layer of Rummery side straps 38, 68, 68a, and 68b and a patient-contacting surface of Rummery side straps 38, 68, 68a, and 68b; see claim 22 above) and/or the at least one actuator.
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Rummery (US 20100229868 A1) in view of McLaren (US 11986595 B2) in view of Gareth (WO 2019003094 A1) in view of Togliatti (US 20200142434 A1) in view of McLaren & Hammer (US 20150283349 A1) as applied above in claim 18, and further in view of Dunn et al. (US 20140209098 A1; hereinafter “Dunn”).
Regarding claim 21, Rummery as modified teaches the invention as set forth in claim 18, but is silent to wherein the at least one sensor (Togliatti: 306a and 306b; Fig. 3) and/or the at least one actuator comprises circuitry that is at least partially formed by one or more conductive threads, and/or one or more conductive ink traces.
However, Dunn teaches headgear that is made of conductive yarn or thread to convey electricity and/or data to and from sensors, tensioning systems, on/off buttons, power sources, computer chips, and controllers ([0050]).
Therefore, it would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to further modify Rummery to be constructed from conductive yarn or thread as taught by Dunn such that the at least one sensor (Togliatti: 306a and 306b; Fig. 3) comprises circuitry that is at least partially formed by one or more conductive threads (Dunn: [0050]) to allow the sensors to be activated via power supply of the conductive thread, and provide a means of transmitting data from the sensors (Dunn: [0050], lines 8-9).
Claims 24-25 are rejected under 35 U.S.C. 103 as being unpatentable over Rummery (US 20100229868 A1) in view of McLaren (US 11986595 B2) in view of Gareth (WO 2019003094 A1) in view of Togliatti (US 20200142434 A1) in view of McLaren & Hammer (US 20150283349 A1) as applied above in claim 18, and in further view of Schneider et al. (US 20080092898 A1; hereinafter “Schneider”).
Regarding claim 24, Rummery as modified teaches the invention as set forth in claim 18, but is silent to comprising a wireless communications interface for transmitting data from the at least one sensor to one or more external computing devices, and/or for receiving data at the at least one actuator from the one or more external computing devices.
However, Schneider teaches wireless communication for transmitting data from an EEG sensor, EOG sensor, EMG sensor, and/or heart rate sensor with a remote electronics module, where the EEG sensor, EOG sensor, EMG sensor, and/or heart rate sensor can be incorporated into headgear for a respiratory therapy device (Schneider: [0028], lines 9-21).
Therefore, it would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to further modify Rummery with the wireless communication to transmit data from one or more sensors located in headgear to a remote electronics module as taught by Schneider such that a wireless communications interface for transmitting data (Schneider: wireless communication, [0028], lines 9-21) from the at least one sensor (Schneider: EEG sensor, EOG sensor, EMG sensor, and/or heart rate sensor located within headgear; [0028], last sentence of paragraph) to one or more external computing devices (Schneider: [0028], lines 9-21) to transmit the monitored signals to an external unit for analysis to improve patient comfort and quality of respiratory therapy (Schneider: [0029], line 12).
Regarding claim 25, Rummery as modified teaches the invention as set forth in claim 18, wherein the at least one sensor (Schneider: EEG sensor, EOG sensor, EMG sensor, and/or heart rate sensor located within headgear; [0028], last sentence of paragraph) and/or the at least one actuator comprises one or more of: an accelerometer; a gyroscope; a humidity sensor; a temperature sensor; a microphone; a camera; a pulse oximeter; an EEG sensor; an EMG sensor; an EOG sensor; a touch sensor; a vibration device; and an audio output device ([0028], last sentence of paragraph).
Claim 99 is rejected under 35 U.S.C. 103 as being unpatentable over Rummery (US 20100229868 A1) in view of McLaren (US 11986595 B2) in view of Gareth (WO 2019003094 A1) as applied above in claim 1, and in further view of Togliatti (US 20200142434 A1) and Schneider (US 20080092898 A1).
Regarding claim 99, Rummery as modified teaches the invention as set forth in claim 1, but is silent to further comprising at least one sensor embedded within the continuous loop of material formed by the front section and the rear section.
However, Togliatti teaches one or more sensors (306; Fig. 3) in headgear (305; [0028], lines 4-6) of a CPAP system (300; Fig. 3), where the one or more sensors (306; Fig. 3) are disposed in a strap of the headgear (see position of 306a and 306b in headgear 305; Figs. 3 and 4a; [0028], lines 5-6; [0019], lines 1-3, where the one or more sensors are the one or more sensors 306).
Therefore, it would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the continuous loop of material formed by the front section and the rear section (see claim 1 above), as taught by Rummery, to include at least one sensor embedded therein, as taught by Togliatti (306; [0028], lines 4-6; [0019], lines 1-3), to improve patient safety by adjusting therapy delivered to the patient according to at least the data gathered by the sensors (Togliatti [0027, lines 12-14 and [0031]).
Rummery as modified by Togliatti fails to teach wherein the at least one sensor is configured to measure an attribute of the patient or an attribute of the ambient atmosphere.
However, Schneider an EEG sensor, EOG sensor, EMG sensor, and/or heart rate sensor can be incorporated into headgear for a respiratory therapy device (Schneider: [0028], lines 9-21).
Therefore, it would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to substitute the sensors, taught by Togliatti, for at least one of an EEG sensor, EOG sensor, EMG sensor, and/or heart rate sensor, as taught by Schneider, to personalize the treatment being supplied to the patient (Schneider [0028] and [0079]).
Claim 100 is rejected under 35 U.S.C. 103 as being unpatentable over Rummery (US 20100229868 A1) in view of McLaren (US 11986595 B2) in view of Gareth (WO 2019003094 A1) in view of view of Togliatti (US 20200142434 A1) in view of Schneider (US 20080092898 A1) as applied above in claim 99, and in further view of Freestone et al. (US 20180207385 A1; hereinafter “Freestone”).
Regarding claim 100, Rummery as modified teaches the invention as set forth in claim 99, but is silent to further comprising a processor module embedded within the continuous loop of material.
However, Freestone teaches an analogous headgear assembly (3010; Figs. 83-87) where a smart hub (3050; Figs. 83-87) can transmit collected data to an external computing device (first sentence of [0297]; [0298]), where the smart hub is located within a top strap of the headgear assembly (see second to last sentence of [0297]; Figs. 87).
Therefore, it would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the continuous loop of material formed by the front section and the rear section (see claim 1 above), as taught by Rummery, to include the smart hub, as taught by Freestone (3050; Figs. 83-87), such that data can be transmitted to an external computing device (Freestone first sentence of [0297]; Freestone [0298]) to improve treatment received by the patient by monitoring compliance and efficacy of therapy (Freestone first sentence of [0297]).
Claim 101 is rejected under 35 U.S.C. 103 as being unpatentable over Rummery (US 20100229868 A1) in view of McLaren (US 11986595 B2) in view of Gareth (WO 2019003094 A1), and in further view of Barlow et al. (WO 2020157559 A1; hereinafter “Barlow”).
Regarding claim 101, Rummery discloses a patient interface (Fig. 14a) comprising:
a plenum chamber (32; Fig. 14a; EXAMINER NOTE: [0068] of Applicant’s specification recites “a patient interface, e.g., the plenum chamber”, hence patient interface 32 is interpreted as a plenum chamber), said plenum chamber including a plenum chamber inlet port sized and structured to receive a flow of air at a therapeutic pressure for breathing by a patient (32 includes inlet port to receive 17 and 16, such that a flow of pressurized breathable gas can be delivered from 16 to 32 and the patient, see [0212] and [0221]; Fig. 14a);
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 of 32, e.g. nozzle arrangement, see [0221]; Figs. 14a-14b), said seal-forming structure having a hole therein such that the flow of air is delivered to at least an entrance to the patient's nares (nozzle arrangement of 32 is a nasal cannula, hence flow of air from 32 travels through nozzle arrangement to be delivered to the nares of the patient, see Figs. 14a-14b), the seal-forming structure constructed and arranged to maintain said therapeutic pressure in the plenum chamber throughout the patient's respiratory cycle in use ([0009]-[0010]; [0153]).
Rummery fails to explicitly disclose a positioning and stabilising structure according to claim 1.
However, Rummery as modified by McLaren and Gareth in claim 1 above does teach a positioning and stabilising structure according to claim 1 (see claim 1 above), the positioning and stabilising structure being configured to provide a force to hold the seal-forming structure in a therapeutically effective position on the patient's head ([0219]; [0138], lines 1-6, where 68b is included in 68 and 38, see Fig. 14a; see 103 rejection of claim 1 above).
Rummery as modified is silent to the plenum chamber (32; Fig. 14a) pressurisable to a therapeutic pressure of at least 6 cmH2O above ambient air pressure.
However, Barlow teaches an analogous patient interface (Fig. 4a), where a seal formed with a region of a patient’s face surrounding an entrance to the patient’s airways, and a plenum chamber of the patient interface is pressurisable to a therapeutic pressure of at least 6 cmH20 above ambient air pressure to maintain the delivery of pressurized air at a therapeutic pressure of at least 6 cmH2O above ambient pressure to the patient’s nares ([0144]).
Therefore, it would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the seal-forming structure taught by Rummery with the seal-forming structure taught by Barlow, such that a pressurized flow of at least 10 cmH2O being delivered to the patient is maintained during therapy (Barlow [0144]) to guarantee a successful therapy session for the patient.
Response to Arguments
Applicant’s arguments with respect to claim 1 have been considered but are moot because the arguments rely on amended limitations that necessitate new ground of rejection.
On pages 8-12 of the Remarks filed on 02/02/2026, Applicant argues the combination of Rummery and McLaren proposed in the Office Action mailed on 10/01/2025 fails to teach or suggest the first lower textile portion is configured to be proximate to the first front part and to overlay the patient’s frontal bone in the first position when the positioning and stabilizing structure is not connected to the patient interface, as recited in amended claim 1. However, Rummery does teach a first lower textile portion is configured to be proximate to the first front part (Fig. 14a; [0222], lines 5-7, where if the length of 68a and 68b is substantially equal, 68b would be located proximally to 68a; see 103 rejection of claim 1 above). Examiner agrees with Applicant’s position that Rummery alone, or in combination with McLaren, fails to teach or suggest the first lower textile portion is configured to overlay the patient’s frontal bone in the first position when the positioning and stabilizing structure is not connected to the patient interface. However, Rummery in combination with McLaren (side straps 204 are elastic and are positionable over patient’s frontal bone, see Fig. 13a and col.5, line 45) and Gareth (yoke 2202 received recessed region of a mask interface 2102 and 2106 retains seal retention band 2300 such that the patient interface is removably connected to the headgear, see Fig. 74 and pg. 3, lines 25-27) does teach the first lower textile portion is configured to overlay the patient’s frontal bone in the first position when the positioning and stabilizing structure is not connected to the patient interface (see 103 rejection of claim 1 above).
Regarding newly presented claim 99, Applicant states the sensors (306) taught by Togliatti are tension sensors and fail to measure an attribute of the patient or an attribute of the ambient atmosphere, as recited in newly presented claim 99 (see Remarks pg. 13). Applicant further states Schneider teaches sensors (88, 92) attached to straps (74,76), but fails to disclose or teach the sensors (88, 92) are embedded in the straps, as recited in newly amended claim 99. However, Rummery in combination with McLaren and Gareth, as presented in the rejection of amended claim 1 under 35 U.S.C. 103, and further in view of Togliatti and Schneider does teach or suggest at least one sensor embedded within the continuous loop of material formed by the front section and the rear section, wherein the at least one sensor is configured to measure an attribute of the patient or an attribute of the ambient atmosphere (see 103 rejection of claim 99 above).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Guney & Scheiner (WO 2020079617 A1): Regarding a patient interface with a plenum chamber and a seal-forming structure, where the plenum chamber is configured to be pressurized to a therapeutic pressure of at least 6 cmH2O.
Sofranko & Greenberg (WO 2012085755 A1): Regarding headgear with a hole therein to facilitate the connection and disconnection of a patient interface.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/ABIGAYLE DALE/Examiner, Art Unit 3785
/BRANDY S LEE/Supervisory Patent Examiner, Art Unit 3785
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