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 .
Status of Claims
The present Office action is responsive to the Preliminary Amendment filed on 03-22-2024. As directed, claims 1-33 have been canceled, and new claims 34-51 have been added. Thus, claims 34-51 are currently pending examination.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Claim Objections
Claims 34, 40, 42, and 44-45 are objected to because of the following informalities:
At claim 34, line 8, it is suggested that “contacts the patient’s face” be replaced with “is configured to contact the patient’s face” to more explicitly avoid claiming the human organism.
At claim 34, line 12, it is suggested that “the length” be replaced with “a length” as the limitation has not been introduced previously.
At claim 40, line 3, it is suggested that “the entire” be replaced with “an entire” as the limitation has not been previously introduced.
At claim 42, line 4, it is suggested that “returns” be replaced with “is configured to return” for clarity.
At claim 44, line 2, it is suggested that “a” be added before “width” to provide antecedent basis for the claim term.
At claim 45, lines 2-3, it is suggested that “the width” be replaced with “a width” as the width of the thermoformable layer has not been previously introduced, only the width of the headgear structure.
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 44-45 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.
Regarding claim 44, lines 3-5 recite “a direction or directions” twice, which each render the claim indefinite. This is because it is unclear, given that the thermoformable layer is part of the headgear structure, if the direction or directions of claim 44 are the same or different than the first direction and the second direction in claim 43 from which claim 44 depends. For the purposes of examination, claim 44 will be interpreted such that the thermoformable layer is configured to stretch in a direction/directions that at least coincide with the first direction of claim 43, and resist stretch in a direction/directions that coincides with the second direction of claim 43.
Claim 45 is rejected by virtue of its dependence on claim 44.
Regarding claim 45, lines 1-2 recite “the thermoformable material” which renders the claim indefinite. This is because the dependency chain including claim 45 lacks antecedent basis for the claim term, and therefore it is unclear whether “the thermoformable layer” should refer instead to “a thermoformable layer” or if one of claims 43-45 are meant to depend from claim 38 which introduces “a thermoformable layer”. For the purposes of examination, the claim limitation will be interpreted as “a thermoformable material”.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 34-38, 40-42, 46, and 48-51 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Barlow (WO 2020/157559).
Regarding claim 34, Barlow discloses a positioning and stabilising structure (3300) configured to hold a seal-forming structure (3100) of a patient interface (3000) in a sealing position on a patient's face (paragraph 381, lines 1-5; paragraph 395, lines 1-6; Fig. 4B), the positioning and stabilising structure (3300) comprising:
a headgear structure (right and left arms 3302 and 3304 including tube 3350) configured to extend, in use, over a portion of the patient's face and/or head (paragraph 381, lines 3-5; paragraph 410, lines 1-6; Fig. 4B), the headgear structure (right and left arms 3302 and 3304 including tube 3350) comprising:
a sleeve (comprisal of 3360 and 3366) comprising an outer surface (outermost layers of 3360 and 3366 of Fig. 4F-1 forming the outer perimeter of 3352 and 3354) and an inner surface (innermost portion of 3360 and 3366 that textile sheets 3362 and 3370 contact in Fig. 4F-1), wherein the outer surface (outermost layers of 3360 and 3366 of Fig. 4F-1 forming the outer perimeter of 3352 and 3354) of the sleeve (comprisal of 3360 and 3366) forms an outer surface of the headgear structure (right and left arms 3302 and 3304 including tube 3350) which contacts the patient's face and/or head in use (paragraph 425, lines 1-10; paragraph 426, lines 1-9; paragraph 499, lines 8-23; Figs. 8C-D); and
a thermoformable layer (3362), wherein the thermoformable layer (3362) is thermoformed to the inner surface (innermost portion of 3360 and 3366 that textile sheets 3362 and 3370 contact in Fig. 4F-1) of the sleeve (comprisal of 3360 and 3366) to provide a pre-defined shape to the sleeve (comprisal of 3360 and 3366) and form an inner surface of the headgear structure (right and left arms 3302 and 3304 including tube 3350) which surrounds a cavity (3372) extending through at least a portion of the length of the headgear structure (right and left arms 3302 and 3304 including tube 3350) (paragraph 426, lines 1-11; paragraph 427, lines 1-5, see “air passage”; paragraph 499, lines 1-23, see “thermoformed to a predetermined shape”; paragraph 500, lines 1-4; Figs. 4B, 4F-4F-2, and 8A-F), and wherein the outer surface (outermost layers of 3360 and 3366 of Fig. 4F-1 forming the outer perimeter of 3352 and 3354) of the sleeve (comprisal of 3360 and 3366) is circumferentially continuous (paragraph 431, lines 1-7, note “cylindrical” for a circular cross-section; Figs. 4B and 4F, where the outer perimeter of the tube 3350 forms a continuous surface to enclose the cavity 3372).
Regarding claim 35, Barlow discloses the positioning and stabilizing structure of claim 34, as discussed above.
Barlow further discloses wherein the inner surface (innermost portion of 3360 and 3366 that textile sheets 3362 and 3370 contact in Fig. 4F-1) of the sleeve (comprisal of 3360 and 3366) is continuous (see each of Figs. 4F and 8F where the inner tube surface forms a continuous enclosure for the cavity).
Regarding claim 36, Barlow discloses the positioning and stabilizing structure of claim 34, as discussed above.
Barlow further discloses wherein the inner surface (innermost portion of 3360 and 3366 that textile sheets 3362 and 3370 contact in Fig. 4F-1) of the sleeve (comprisal of 3360 and 3366) is configured to be smooth (see each of Figs. 4F-4F-2 and 8F where the inner tube surface forms a smooth surface free of protrusions, ridges, or other outcroppings).
Regarding claim 37, Barlow discloses the positioning and stabilizing structure of claim 34, as discussed above.
Barlow further discloses wherein the sleeve (comprisal of 3360 and 3366) is a continuous structure, when viewed in cross-section from a side in a direction substantially parallel to a longitudinal axis of the headgear structure (right and left arms 3302 and 3304 including tube 3350) (see the portion of tube 3350 in Fig. 4F, and note that surfaces 3360 and 3362 are continuous along the length of the tube; see also Fig. 4B, where tube 3350 includes a continuous outer surface along its length, from the patient’s left side to the patient’s right side).
Regarding claim 38, Barlow discloses the positioning and stabilizing structure of claim 34, as discussed above.
Barlow further discloses wherein the thermoformable layer (3362) comprises a thermoformable material (paragraph 499, lines 1-23, see “thermoformed to a predetermined shape”; paragraph 500, lines 1-4; note Figs. 4F-4F-2, where each of layers 3360 and 3362 form part of inner and outer surfaces 3352 and 3354, which are detailed as being thermoformed).
Regarding claim 40, Barlow discloses the positioning and stabilizing structure of claim 34, as discussed above.
Barlow further discloses wherein the thermoformable layer (3362) is a continuous structure, when viewed in cross-section from a side in a direction substantially parallel to a longitudinal axis of the headgear structure (right and left arms 3302 and 3304 including tube 3350) (see each of Figs. 4F and 8A-D where 3362 is a continuous structure along the length of tube 3350).
Regarding claim 41, Barlow discloses the positioning and stabilizing structure of claim 34, as discussed above.
Barlow further discloses wherein the headgear structure (right and left arms 3302 and 3304 including tube 3350) comprises a patient facing side and a non-patient facing side (note Figs. 4B and 4F-4F-2, where tube 3350 includes inner and outer surfaces 3352 and 3354, where 3352 is arranged to contact the patient and 3354 is arranged in a non-contacting manner with the patient, note also that the exterior of 3352 and 3354 may be interpreted as the patient-contacting side, and interior components 3362 and 3370/3364/3368 may be interpreted as non-patient contacting; paragraph 425, lines 1-10), wherein at least one of the patient facing side and the non-patient facing side is substantially convex shaped (paragraph 427, lines 1-5, see D-shaped; note paragraph 431, where in a cylindrical form, 3354 would still have a convex curvature).
Regarding claim 42, Barlow discloses the positioning and stabilizing structure of claim 34, as discussed above.
Barlow further discloses wherein the thermoformable layer (3362), when thermoformed to the inner surface (innermost portion of 3360 and 3366 that textile sheets 3362 and 3370 contact in Fig. 4F-1) of the sleeve (comprisal of 3360 and 3366), configures the headgear structure (right and left arms 3302 and 3304 including tube 3350) to be substantially resilient or to act resiliently such that the headgear structure (right and left arms 3302 and 3304 including tube 3350) returns to the predefined shape when flexed, bent, and/or compressed from the predefined shape (paragraph 439, lines 1-4, where although outer layer 3354 is more resilient than inner layer 3352, it is implied that 3352 still includes resiliency; paragraph 499, lines 11-13 and 18-23; paragraph 507, lines 1-6; paragraph 522, lines 4-5).
Regarding claim 46, Barlow discloses the positioning and stabilizing structure of claim 34, as discussed above.
Barlow further discloses the headgear structure (right and left arms 3302 and 3304 including tube 3350) further comprises a rigidiser component (paragraph 436, lines 1-4).
Regarding claim 48, Barlow discloses the positioning and stabilizing structure of claim 46, as discussed above.
Barlow further discloses wherein the rigidiser component and the headgear structure (right and left arms 3302 and 3304 including tube 3350) are permanently attached or formed together (see paragraph 468: “Further, separate rigidizers beyond inner layer 3352 and outer layer 3354 may be included in various portions of tube 3350, such as within arm support 3314 or along the outer surfaces of arm support 3314”, where within implies a permanent attachment, particularly given that paragraph 468 further defines the arm 3314 as being comprised of layers 3352 and 3354, see Figs. 4F-4F-2).
Regarding claim 49, Barlow discloses the positioning and stabilizing structure of claim 34, as discussed above.
Barlow further discloses wherein a first region of the headgear structure (right and left arms 3302 and 3304 including tube 3350) is configured to be harder, stiffer or more rigid than a second region of the headgear structure (right and left arms 3302 and 3304 including tube 3350) (paragraph 439, lines 4-10).
Regarding claim 50, Barlow discloses the positioning and stabilizing structure of claim 34, as discussed above.
Barlow further discloses wherein a section of the thermoformable layer (3362) located in the first region of the headgear structure (right and left arms 3302 and 3304 including tube 3350) comprises a greater amount of a thermoformable material with respect to a section of the thermoformable layer (3362) located in the second region of the headgear structure (right and left arms 3302 and 3304 including tube 3350) (paragraph 421, lines 11-13; note paragraph 426 where 3362 is a “textile membrane”; see also paragraph 499, lines 1-23 and paragraph 500, lines 1-4 for thermoforming).
Regarding claim 51, Barlow discloses the positioning and stabilizing structure of claim 34, as discussed above.
Barlow further discloses a patient interface (3000) (paragraph 395, lines 1-3; Fig. 4B), wherein the patient interface (3000)comprises:
a plenum chamber (3200) pressurisable to a therapeutic pressure of at least 6 cmH2O above ambient air pressure (paragraph 95, lines 1-3; paragraph 404, lines 1-5; Fig. 4B), wherein the plenum chamber (3200) comprises an inlet configured to receive a flow of air at the therapeutic pressure for breathing by a patient (paragraph 95, lines 1-6, see “plenum chamber inlet port”);
a seal-forming structure (3100) configured to form a seal with a region of the patient's face surrounding an entrance to the patient's airways, wherein the seal-forming structure (3100) is configured to maintain said therapeutic pressure in the plenum chamber (3200) throughout the patient's respiratory cycle in use (paragraph 95, lines 5-11; paragraph 381, lines 1-6; paragraph 395, lines 1-10; Fig. 4B).
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 non-obviousness.
Claims 39 and 43-45 are rejected under 35 U.S.C. 103 as being unpatentable over Barlow (WO 2020/157559).
Regarding claim 39, Barlow discloses the positioning and stabilizing structure of claim 34, as discussed above.
As presently construed, Barlow fails to disclose wherein the thermoformable material comprises a thermo-fusible yarn.
However, in a separate embodiment, Barlow teaches imbuing an inner portion of an analogous tube with a rigidiser portion by providing the inner tube portion with a thermo-fusible yarn, wherein the rigidiser portion provides rigidity to the tube in desired locations of the tube (paragraph 679, lines 1-7; paragraph 680, lines 1-5; note that since the yarn is configured to be melted, it is read as thermo-fusible).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the thermoformable material residing on the inner portion of Barlow’s tube with a thermo-fusible yarn, as taught by Barlow’s additional embodiment, in order to form a rigidiser that provides rigidity to the tube in desired locations of the tube.
Regarding claim 43, Barlow discloses the positioning and stabilizing structure of claim 34, as discussed above.
As presently construed, Barlow fails to disclose wherein the headgear structure is configured to stretch in a first direction and restrict stretching in a second direction, wherein the first direction is different to the second direction.
However, in a separate embodiment, Barlow teaches wherein the headgear structure is configured to stretch in a first direction and restrict stretching in a second direction, wherein the first direction is different to the second direction in order to accommodate particular tubular stretching to due applied air pressure and resist such stretching in other directions (paragraph 417, lines 1-15, note that the tube throughout the embodiments of the invention is part of the headgear structure, see e.g. tube 3350 of Fig. 4B).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the headgear structure of Barlow such that the headgear structure is configured to stretch in a first direction and restrict stretching in a second direction, wherein the first direction is different to the second direction, as taught in Barlow’s separate embodiment, in order to accommodate particular tubular stretching to due applied air pressure and resist such stretching in other directions.
Regarding claim 44, Barlow discloses the positioning and stabilizing structure of claim 43, as discussed above.
Barlow further discloses wherein the sleeve (comprisal of 3360 and 3366) is configured to stretch in directions which extend along the length and width of the headgear structure (right and left arms 3302 and 3304 including tube 3350) (paragraph 524, lines 1-10, note that intake 3608 has length and width dimensions to be stretched around in Figs. 4M-N), and wherein the thermoformable layer (3362) is configured to stretch in a direction or directions which extend along the length of the headgear structure (right and left arms 3302 and 3304 including tube 3350) and restrict stretching in a direction or directions which extend along the width of the headgear structure (right and left arms 3302 and 3304 including tube 3350) (paragraph 913, lines 1-3, note that resistance to stretch still allows for some amount of stretch; note paragraph 426, where 3362 is a textile membrane).
Regarding claim 45, Barlow discloses the positioning and stabilizing structure of claim 44, as discussed above.
As presently construed, Barlow fails to disclose wherein the thermoformable material is positioned on the thermoformable layer to extend along at least a portion of the width of the thermoformable layer to restrict stretching along the width of the headgear structure.
However, in a separate embodiment, Barlow teaches imbuing an inner portion of an analogous tube with a rigidiser portion by providing the inner tube portion with a thermo-fusible yarn, wherein the rigidiser portion provides rigidity to the tube in desired locations of the tube, where, given the 3-D nature of a yarn, the thermo-fusible yarn extends along at least a portion of the width of the inner tube (paragraph 679, lines 1-7; paragraph 680, lines 1-5, note increased stiffness, where stiffness is a resistance to stretch/flexibility/bending; note that since the yarn is configured to be melted, it is read as thermo-fusible).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the thermoformable material residing on the inner portion of Barlow’s tube with a thermo-fusible material that extends along at least a portion of the width of the thermoformable layer to restrict stretching along the width of the headgear structure, as taught by Bartlow’s additional embodiment, in order to form a rigidiser that provides rigidity to the tube in desired locations of the thermoformable layer.
Claims 46 and 47 are rejected under 35 U.S.C. 103 as being unpatentable over Barlow (WO 2020/157559), as applied to claim 34 above, in view of Ovzinsky (US 2017/0333662).
Regarding claim 46, Barlow discloses the positioning and stabilizing structure of claim 34, as discussed above.
Under a separate interpretation, Barlow fails to disclose wherein the headgear structure further comprises a rigidiser component.
However, Ovzinsky teaches an air delivery conduit (1020) (see paragraph 208, lines 1-3 and note that analogous conduit 520 in Fig. 6 is configured as a headgear structure) comprising a rigidiser component (1060) to imbue the conduit with crush resistant properties (paragraph 209, lines 1-7; Fig. 40-1).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the headgear structure of Barlow to further include a rigidiser component placed within the headgear structure, as taught by Ovzinsky, in order to imbue the conduit with crush resistant properties.
Regarding claim 47, Barlow in view of Ovzinsky disclose the positioning and stabilizing structure of claim 46, as discussed above.
Modified Barlow further discloses wherein the rigidiser component (Ovzinsky: 1060) is positioned inside the cavity (see Ovzinsky at Fig. 38, where 1060 is positioned in the cavity formed by 1050/1055, where, as modified 1060 would be placed in cavity 3372 of Barlow to impart crush resistance).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Rummery (US 11,752,367) is cited for its conduit wrap 450 as shown in Fig. 25O.
Hammer (WO 2015/151019) is cited for its hollow headgear as shown throughout the figures.
Huddart (US 2016/0074614) is cited for its hollow headgear as shown in Figs. 123A-132C.
Henry (US 2016/0296720) is cited for its headgear with a cavity as shown in Figure 65.
Guney (WO 2021/081595) is cited for its headgear complete with cavity as shown in Figs. 5-7.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PAIGE BUGG whose telephone number is (571)272-8053. The examiner can normally be reached Monday-Friday 9-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kendra Carter can be reached at (571) 272-9034. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PAIGE KATHLEEN BUGG/Primary Examiner, Art Unit 3785
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