DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. 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
2. This office action is responsive to the preliminary amendment filed on March 13, 2026. As directed by the amendment: claims 89, 92, 94, and 98 have been amended, claim 90 has been cancelled, and no claims have been added. Thus, claims 89 and 91-108 are presently pending in this application.
Claim Rejections - 35 USC § 112
3. 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.
4. Claim 98 is 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 98 recites the limitation "the clearance" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 103
5. 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.
6. 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.
7. Claim(s) 89-104 and 106 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kooij et al. (US 2019/0022343) in view of Rummery et al. (US 2014/0007881).
Regarding claim 89, Kooij discloses a positioning and stabilizing structure (fig. 17, patient interface 3000) to provide a force to hold a seal-forming structure (fig. 17, cushion assembly 3150) in a therapeutically effective position on a patient's head (fig. 17, rear headgear strap 3310 can secure the cushion assembly 3150 in place during use), the 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 (fig. 4A, cushion assembly 3150 comprises a seal-forming structure 3100 which seals the airways, see [0134]) for sealed delivery of a flow of air at a therapeutic pressure of at least 6 cmH20 above ambient air pressure ([0024] states that a positive pressure of about 10 cmH2O relative to ambient air pressure can be provided) to at least the patient's nares (fig. 4A, nasal seal-forming structure 3170 delivers air to the nares) throughout the patient's respiratory cycle in use ([0024] states that air is provided to the nose during therapy), the positioning and stabilizing structure comprising:
a gas delivery tube (fig. 17, headgear tube 3350) to receive the flow of air from a connection port (fig. 17, top opening 3343 allows connection between an air circuit and connection port, see [0337]) on top of the patient's head (fig. 17, the top opening and therefore connection port are located at the top of the device) and to deliver the flow of air to the entrance of the patient's airways ([0024]) via the seal-forming structure ([0133] states that cushion assembly 3150 facilitates the supply of air to the airways), the gas delivery tube being constructed and arranged to contact, in use, at least a region of the patient's head superior to an otobasion superior of the patient's head (fig. 11, shows an example of headgear tubes 3350 being positioned at a distance from the top, front section of the patient’s ear),
the positioning and stabilizing structure further comprising an elongate textile sleeve (fig. 17, elastic sleeve 3340 which can be made of fabric for easy washing, see [0339]) provided around the gas delivery tube ([0335] states that sleeves 3340 cover tubes 3350) and arranged to be in contact, in use, with the patient's face ([0339] states that sleeve 3340 may contact the patient’s hair or skin in use), the sleeve comprising a wall with an opening therein ([0337] states that sleeves 3340 can include rear or side openings 3342) for allowing the patient to view a portion of the gas delivery tube when the positioning and stabilizing structure is not in use (fig. 17, openings 3342 inherently allow a patient to see the tube because it is not covering the tube),
and further shows the opening as having a width that appears around 50% of the opening (fig. 17, opening 3342), but does not expressly state that the opening is less than 50% of the circumference of the gas delivery tube, when the opening and the tube are measured at the same longitudinal position.
However, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the opening of the structure of Kooij to be less than 50% of the circumference of the gas delivery tube, for the purpose of allowing a connection point between the rear straps and the tubes, and since it has been held that where the general conditions of a claim are discloses in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. Furthermore, Applicant has not provided criticality that the opening being less than 50% of the circumference of the tubes provides an advantage, is used for a particular purpose, or solves a stated problem beyond stating that it ensures material at the edge of the opening stays in contact with the tube, see the paragraph [0253] in the specification. Further it appears the opening of the structure of Kooij would perform equally well with the recited opening size. MPEP 2144.05(II).
The modified structure of Kooij further reads on the elongate textile sleeve is made from a material which is elastic (fig. 17, elastic sleeves 3340 are defined as elastic, see [0334]) in an axial direction and a circumferential direction ([0334] states the sleeve is made of an elastic material which would inherently allow flexion in a axial/circumferential direction), but does not expressly state that the material has a greater elasticity in the axial direction than the circumferential direction.
However, Rummery teaches of an air delivery conduit that has an outer textile or fabric layer (fig. 2-3, textile 220) than can have different fibers or threads for the warp and weft of the textile ([0061]) and therefore stretch more in the lengthwise direction (fig. 2-2, direction B) allowing the conduit to more readily deform ([0061]).
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to replace the material of the elastic sleeves of Kooij with the material as taught by Rummery as a simple substitution of one known element for another to obtain a predictable result of wrapping around the gas delivery tubes while still allowing the gas delivery tubes to bend or deform.
The further modified device of Kooij reads on the textile sleeve is made of a material that has a greater elasticity in the axial direction than the circumferential direction (Rummery [0061]).
Regarding claim 91, the modified structure of Kooij reads on the limitations of claim 89 and further shows the opening as having a rounded shape (Kooij fig. 17, 3342), but does not expressly disclose that the shape is substantially oval, elliptical or stadium shaped.
However, it would have been an obvious matter of design choice to one of ordinary skill before the effective filing date of the claimed invention to make the opening an oval, elliptical, or stadium shape since such a modification would have involved a mere change in the form or shape of a component. A change in shape or form is generally recognized as being within the level of ordinary skill in the art. Further, Applicant has not provided criticality that the shape of the opening provides and advantage, is used for a particular purpose, or solves a stated problem. It appears modified opening of Kooij would perform equally well with an oval, elliptical, or stadium shape for allowing a strap connection to the tubes 3350.
Regarding claim 92, the modified structure of Kooij reads on the limitations of claim 89 and further reads on the gas delivery tube comprises a concertina portion (Kooij fig. 17, concertina tube sections 3362) and a non-concertina portion (Kooij fig. 17, non-adjustable tube section 3363), wherein the non-concertina portion is on the opposite side of the concertina portion Kooij (fig. 17, the non-adjustable section 3363 is opposite of the connection port area 3343 relative to the concertina tube section 3362), wherein the textile sleeve is arranged such that the entire edge of the opening lies over the non-concertina portion of the gas delivery tube (Kooij fig. 17, elastic sleeve 3340 fully covers the concertina tube section 3362).
Regarding claim 93, the modified structure of Kooij reads on the limitations of claim 92 and further reads on the sleeve extends to the end of the non-concertina portion of the gas delivery tube which is opposite the concertina portion (Kooij fig. 17, elastic sleeve 3340 extends until it reaches cushion assembly 3150 thereby extending to the end of the non-adjustable section 3363).
Regarding claim 94, the modified structure of Kooij reads on the limitations of claim 89 and further reads on a tab (Kooij fig. 17, 3345) which connects to rear strap (fig. 17, 3310) near the opening of the elastic sleeve (Kooij fig. 17, 3342), but does not expressly show the tab being connected to the gas delivery tube.
However, Kooij teaches of another embodiment (fig. 7A) where the tab (fig. 7A, 3345) is connected directly to the gas delivery tube (fig. 7A, 3350).
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to replace the tab of the modified structure of Kooij with the tab connected directly to the gas delivery tube as taught by the embodiment shown in figure 7A of Kooij as a simple substitution of one known element for another to obtain a predictable result of connecting the structure with a rear strap.
Regarding claim 95, the modified structure of Kooij reads on the limitations of claim 94 and further reads on the strap engaging portion comprises a tab (Kooij fig. 17, tab 3345).
Regarding claim 96, the modified structure of Kooij reads on the limitations of claim 94 and further reads on a clearance between the edge of the opening (Kooij fig. 17, the edge of opening 3342 is shown to be above and below the position of tab 3345) and the strap engaging portion (Kooij fig. 17, tab 3345).
Regarding claim 97, the modified structure of Kooij reads on the limitations of claim 96 and further reads on the clearance is in the longitudinal direction (Kooij fig. 17, opening 3342 has its edge above and below the position of tab 3345 where the longitudinal direction is interpreted as along the tubes 3350).
Regarding claim 98, the modified structure of Kooij reads on the limitations of claim 92 and further reads on the clearance allows the gas delivery tube to stretch, in use (Kooij fig. 17, concertina tube sections 3362 allow stretching of the gas delivery tube), without the strap engaging portion contacting the edge of the opening (Kooij fig. 17, tab 3345 is located centrally relative to the edge of the opening 3342 which would allow at least some expansion from the concertina tube section 3362)
Regarding claim 99, the modified structure of Kooij reads on the limitations of claim 89 and further states that the tubes 3350 are between 15-30 cm (Kooij [0161]) and the opening appears to be around 30% of that value (Kooij fig. 17, opening 3342 appears to be the length of around a third of the tube), but does not expressly disclose that the opening is substantially 65mm long.
However, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify length of the opening of the structure of Kooij to be substantially 65mm long, for the purpose of allowing the rear straps to connect to the tubes ([0337]), and since it has been held that where the general conditions of a claim are discloses in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. Furthermore, Applicant has not provided criticality that an opening substantially 65mm long provides an advantage, is used for a particular purpose, or solves a stated problem beyond stating that the length of the opening is substantially 65mm and may vary to accommodate different strap engaging portions, see the paragraphs [0255]-[0256] in the specification. Further it appears the opening of Kooij would perform equally well with the recited length of substantially 65mm. See MPEP 2144.05(II).
Regarding claim 100, the modified structure of Kooij reads on the limitations of claim 89 and further states the rear or side openings allow headgear straps to connect to the tubes (Kooij [0337]), but does not expressly state that the length of the opening is less than 65mm long.
However, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify length of the opening of the structure of Kooij to be less than 65mm long, for the purpose of allowing the rear straps to connect to the tubes ([0337]), and since it has been held that where the general conditions of a claim are discloses in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. Furthermore, Applicant has not provided criticality that an opening less than 65mm long provides an advantage, is used for a particular purpose, or solves a stated problem beyond stating that the length of the opening is substantially 65mm and may vary to accommodate different strap engaging portions, see the paragraphs [0255]-[0256] in the specification. Further it appears the opening in the structure of Kooij would perform equally well with the recited length of less than 65mm. See MPEP 2144.05(II).
Regarding claim 101, the modified structure of Kooij reads on the limitations of claim 96 and further states that the width of the tubes may be in the range of 8-25mm (Kooij [0166]) and the opening appears to be around 100% of the width of the tubes (Kooij fig. 17, opening 3342 appears to expose one side of the tube), but does not expressly disclose that the width of the opening is less than 5mm.
However, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the width of the opening of the structure of Kooij to be less than 5mm, for the purpose of allowing the rear straps to connect to the tubes ([0337]), and since it has been held that where the general conditions of a claim are discloses in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. Furthermore, Applicant has not provided criticality that a width of the opening less than 5mm provides an advantage, is used for a particular purpose, or solves a stated problem beyond stating that it may result in an integrated appearance, may assist in preventing creasing/wrinkling, and can vary to accommodate strap portions of different widths, see the paragraphs [0255]-[0256] in the specification. Further it appears the opening in the structure of Kooij would perform equally well with the recited width of less than 5mm. See MPEP 2144.05(II).
Regarding claim 102, the modified structure of Kooij reads on the limitations of claim 89 and further reads on the textile sleeve comprises a first material on a patient contacting side of the sleeve (Kooij [0340] states that the elastic sleeve can be formed of a textile that helps wick moisture away from the patient’s face and therefore must be in contact with the patient’s face), and a second material on a non-patient contacting side of the sleeve (Kooij [0336] states that elastic sleeve 3340 can be formed of multiple elastic sheets sewn together meaning another material can be used on the non-patient contacting side).
Regarding claim 103, the modified structure of Kooij reads on the limitations of claim 102 and further reads on the first material is connected to the second material by a seam (Kooij [0336] states that the elastic sleeve may be sewn together which requires a seam), wherein the seam is configured to allow stretch in the circumferential direction (Kooij [0334] states the elastic sleeve allows stretching, therefore the seam allows stretching as it is part of the sleeve).
Regarding claim 104, the modified structure of Kooij reads on the limitations of claim 102 and further reads on the first material comprises a moisture wicking knit material (Kooij [0340] states that the elastic sleeve can be formed of a textile that helps wick moisture away from the patient’s face) and the second material comprises a smooth surface (Kooij [0334] states the elastic sleeve can further be made of elastane which would comprise a smooth surface).
Regarding claim 106, the modified structure of Kooij reads on the limitations of claim 89 and further reads on the textile sleeve comprises a connection port opening (Kooij fig. 17, top opening 3343) configured to allow an air circuit or an elbow to be connected to the connection port, in use (Kooij [0337] states that the top opening allows an air circuit 4170 to connect to a port 3600).
8. Claim(s) 105 and 107-108 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kooij in view of Rummery as applied to claim 89 above, and further in view of Kooij et al. (US 2018/0214655) hereinafter Kooij2 and Cross et al. (US 2013/0192943).
Regarding claim 105, the modified structure of Kooij reads on the limitations of claim 89, but is silent on covering the edge of the opening with seam tape to reduce or eliminate fraying of the textile.
However, Kooij2 teaches of a headgear which finishes the edges of the headgear to avoid rough edges and preventing fraying of the material ([0187]) which is accomplished by using a covering material folded over along an elongate edge of a flexible strap ([0051]).
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to provide the edges of the elastic sleeve of the modified structure of Kooij with the covering material as taught by Kooij2 to improve comfort when contacting the edges and prevent fraying of the material (Kooij2 [0187]).
The modified structure of Kooij is still silent on composition of the covering material.
However, Cross states that seam tape is traditionally used to finish fabric edges to prevent fraying ([0004]).
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to replace the covering material of the modified structure of Kooij with the seam tape as taught by Cross as a simple substitution of one known element for another to obtain a predictable result of preventing fraying at the edges of the textile sleeve.
Regarding claim 107, the modified structure of Kooij presented in the rejection to claim 105 reads on the limitations of claim 89 and further reads on seam tape (Cross [0004]) is provided to the edge of the opening (Kooij2 [0051] states the covering material can be folded over an elongate edge) to reduce or eliminate fraying of the textile (Kooij2 [0187]).
Regarding claim 108, the modified structure of Kooij reads on the limitations of claim 107 and further reads on the seam tape provided to the edge of the connection port opening is provided to an inner surface of the textile sleeve (Kooij2 [0051] states that the covering material is folded over and along the elongate edge thereby being on both the outer and inner surface of the elastic sleeve 3340 of Kooij).
Response to Arguments
9. Applicant’s arguments with respect to claim(s) 89 and 91-108 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.
Conclusion
10. 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.
11. Any inquiry concerning this communication or earlier communications from the examiner should be directed to THOMAS Z CHANG whose telephone number is (571)272-0432. The examiner can normally be reached Monday-Friday 9:00 am-5:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Timothy Stanis can be reached at (571)272-5139. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/THOMAS Z CHANG/Examiner, Art Unit 3785
/TIMOTHY A STANIS/Supervisory Patent Examiner, Art Unit 3785
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