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 12, 2026. As directed by the amendment: claims 45, 52-53, 55-56, and 60 have been amended, no claims have been cancelled, and claim 68 has been added. Thus, claims 45-68 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. Claims 53 and 60 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.
Claims 53 and 60 recites the limitation "receiver(s)" in line 2 of claim 53 and line 2 of claim 60. There is insufficient antecedent basis for this limitation in the claim. It is suggested to amend claim 51 to replace “a receiving means” in line 2 with --a plurality of receivers--.
Claim Rejections - 35 USC § 102
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.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
6. Claim(s) 45-48, 50-51, 53-54, 57, 61-64, and 66 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kooij et al. (US 2019/0022343).
Regarding claim 45, Kooij discloses a patient contacting member (fig. 17, sleeves 3340 and strap 3310) configured to releasably engage a gas delivery tube (fig. 17, sleeves 3340 cover tubes 3350) which forms part of a positioning and stabilizing structure for a patient interface (abstract states that the positioning and stabilizing structure can comprise a gas delivery tube, see fig. 17, tubes 3350), the patient contacting member comprising an elongate sleeve portion (fig. 17, elastic sleeves 3340) which is engageable with the gas delivery tube (fig. 17, sleeves 3340 cover tubes 3350) and a strap (fig. 17, rear headgear strap 3310) directly connected to the elongate sleeve portion (fig. 17, rear headgear strap 3310 connects with sleeves 3340 via tabs 3345) and configured to engage a back of a patient's head, in use (fig. 17, rear headgear strap 3310 passes around the back of the patient’s head, see [0173]).
Regarding claim 46, the structure of Kooij discloses the limitations of claim 45 and further discloses the elongate sleeve portion has a length and width (fig. 17, the tubes 3350 have a length between 15-30 cm according to the head of the patient, [0161], and the width of the tubes being in the range of 8-25 mm, [0166]) where the length is more than twice the width (fig. 17 shows the elastic sleeve 3340 around the tubes 3350 and would therefore have similar dimensions to the tubes, and the tube dimensions have a length range more than double the width range).
Regarding claim 47, see the rejection to claim 46 above. The largest width is 2.5 cm and the smallest length is 15 cm meaning the length is more than four times the width regardless of the selected dimensions.
Regarding claim 48, the structure of Kooij discloses the limitations of claim 45 and further discloses the elongate sleeve portion is configured to be located adjacent an interfacing structure (fig. 17, cushion assembly 3150) of the patient interface in use (fig. 17, elastic sleeves 3340 are adjacent to the cushion assembly).
Regarding claim 50, the structure of Kooij discloses the limitations of claim 45 and further discloses the strap is releasably connectable to the elongate sleeve portion (fig. 17, straps 3310 are shown to connect with tabs 3345, further, [0176] states that tabs 3345 have holes to receive the ends of the strap 3310).
Regarding claim 51, the structure of Kooij discloses the limitations of claim 50 and further discloses the elongate sleeve portion comprises a receiving means (fig. 17, tabs 3345) comprising an opening for receiving the strap ([0176] states that tabs 3345 have holes to receive the straps).
Regarding claim 53, the structure of Kooij discloses the limitations of claim 51 and further discloses each said receiver comprises a tab provided with a slot to receive the strap (fig. 17, tabs 3345 on the left and right both show holes for receiving strap 3310).
Regarding claim 54, the structure of Kooij discloses the limitations of claim 45 and further discloses the patient contacting member comprises two elongate sleeve portions ([0336] states that the elastic sleeves 3340 can comprise two sleeves, one on each tube 3350).
Regarding claim 57, the structure of Kooij discloses the limitations of claim 45 and further discloses the strap comprises an elastically extendible portion ([0185] states that the strap 3310 is resiliently extensible).
Regarding claim 61, the structure of Kooij discloses the limitations of claim 45 and further discloses the elongate sleeve portion has a patient contacting side (fig. 17, the inside of the elastic sleeve 3340) and a non-patient contacting side (fig. 17, the portion of 3340 which does not contact the patient such as where tabs 3345 are located), wherein the patient contacting side contacts at least the patient's cheek region, in use (see fig. 3A, the tube 3350 is shown to be against the patient’s cheek region, when covered by sleeve 3340, the patient contacting side of 3340 instead contacts the patient’s cheek region).
Regarding claim 62, the structure of Kooij discloses the limitations of claim 45 and further discloses the elongate sleeve portion has a window portion (fig. 17, 3340 has opening along the sides, [0337] states that sleeves 3340 has a top opening 3343 and openings 3342) in the non-patient contacting side (the area where the opening is would not contact the patient). Regarding claim 63, the structure of Kooij discloses the limitations of claim 62 and further discloses the window portion comprises an opening in the elongate sleeve portion ([0337] states that sleeves 3340 has a top opening 3343 and openings 3342).
Regarding claim 64, the structure of Kooij discloses the limitations of claim 62 and further discloses the window portion comprises a first side and an opposite second side (fig. 17, in opening 3342, the first side is the left and the second side is the right), wherein an elasticated cord is engaged with the first side and the second side ([0339] states that elastic sleeve 3340 can be made of fabric which inherently include fibers. The elastic fiber in the fabric is woven through the elastic sleeve thereby engaging the first and second side of elastic sleeve 3340).
Regarding claim 66, the structure of Kooij discloses the limitations of claim 62 and further discloses a portion of the non-patient contacting side comprises a mesh ([0339] states that the elastic sleeve can be a fabric which is made of woven fibers and therefore is a mesh).
Claim Rejections - 35 USC § 103
7. 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.
8. Claim(s) 52 and 58-60 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kooij.
Regarding claim 52, the structure of Kooij discloses the limitations of claim 50 and further discloses alternative embodiments with multiple straps ([0175]), but does not expressly disclose a plurality of receivers spaced apart along the elongate sleeve portion.
However, Kooij teaches of another embodiment (fig. 10A) which includes a chin strap (fig. 10A, 3320) to further increase stability (see [0174]-[0175]), but is silent on the connection method between the chin strap (fig. 10A, chin strap 3320 appears to be integrally formed).
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to additionally provide the elastic sleeve of Kooij with a chin strap as taught by Kooij to further increase stability ([0175]). Further, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to replace the connection of the chin strap with an additional tab (fig. 17, tab 3345) as taught by Kooij to allow adjustment of the chin strap ([0177]).
Regarding claim 58, the structure of Kooij discloses the limitations of claim 45, but does not expressly disclose that the elongate sleeve portion (fig. 17, elastic sleeve 3340) comprises a rigidized portion.
However, Kooij teaches of rigidizing elements in the tubes 3350 and stabilizing structures 3300 to promote comfort when the interface is worn and maintain a good seal during use ([0160]).
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to additionally provide the elastic sleeve of Kooij with rigidizing elements as taught by Kooij to further control how areas where forces are applied will deform thereby maintaining a good seal and promoting comfort in use ([0160]).
Regarding claim 59, the modified structure of Kooij discloses the limitations of claim 58 and further discloses the rigidized portion is curved (fig. 17, elastic sleeve 3340 is curved and providing rigidizing elements along the elastic sleeve would inherently mean the rigidized portion is curved).
Regarding claim 60, the structure of Kooij reads on the limitations of claim 51, but does not expressly disclose the patient contacting member comprises a further receiver configured to connect to a strap configured to pass around the back of the patient’s neck
However, Kooij teaches of another embodiment (fig. 10A) which includes a chin strap (fig. 10A, 3320) to further increase stability (see [0174]-[0175]), but is silent on the connection method between the chin strap (fig. 10A, chin strap 3320 appears to be integrally formed).
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to additionally provide the elastic sleeve of Kooij with a chin strap as taught by Kooij to further increase stability ([0175]). Further, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to replace the connection of the chin strap with an additional tab (fig. 17, tab 3345) as taught by Kooij to allow adjustment of the chin strap ([0177]).
The modified structure of Kooij reads on the patient contacting member comprises a further receiving means (fig. 17, tab 3345) configured to connect to a strap or strap portion configured to pass around the back of the patient's neck, in use (fig. 10A, chin strap 3320 is positioned under the chin, see [0174], thereby engaging with the neck of the patient).
9. Claim(s) 49, 55-56, and 68 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kooij in view of Veliss et al. (US 2008/0060649).
Regarding claim 49, the structure of Kooij discloses the limitations of claim 45 and further discloses a strap (fig. 17, 3310) contacting the elongate sleeve portion (fig. 17, 3340), but does not expressly state that strap is formed integrally with the elongate sleeve portion.
However, Veliss teaches of back strap (fig. 10-4) that appears to be integrally formed with a sleeve portion (fig. 10-4, sock S).
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to replace the back strap of the structure of Kooij with the back strap as taught by Veliss as a simple substitution of one known element for another to obtain a predictable result of allowing strap to be adjustable and connected to the sleeve portion. Further, "[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985).
Regarding claim 55, the structure of Kooij reads on the limitations of claim 45, but does not expressly disclose that the strap comprises two strap portions and a connector which connects the strap portions to each other.
However, Veliss teaches of back strap (fig. 10-4) that uses a snap fit connector to connect each strap.
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to replace the back strap of the structure of Kooij with the back strap as taught by Veliss as a simple substitution of one known element for another to obtain a predictable result of allowing strap to be adjustable and connected to the sleeve portion.
The modified structure of Kooij reads on the strap comprises two strap portions (Veliss fig. 10-4, one strap is positioned on the left side and the other on the right) and a connector which connects the strap portions to each other (Veliss fig. 10-4 shows a snap-fit connection between two straps which allows adjustment, see Veliss [0145] which states the back strap uses a baseball cap adjuster).
Regarding claim 56, the modified structure of Kooij teaches of the limitations of claim 55 and further teaches the connector (Veliss fig. 10-4 shows a snap-fit connection between two straps which allows adjustment) allows a length of the strap to be adjusted (Veliss fig. 10-4, the snap-fit connector has multiple holes to allow various lengths, see Veliss [0145] which states the back strap uses a baseball cap adjuster).
Regarding claim 68, the structure of Kooij reads on the limitations of claim 45 and further reads on the strap includes a first portion (fig. 17, the left side of rear headgear strap 3310) with a first end (fig. 17, the connection between strap 3310 and tab 3345) fixed to and extending continuously from the sleeve portion (fig. 17, strap 3310 is extends continuously from sleeve 3340 via the connection between strap 3310 and tab 3345) and a second portion (fig. 17, the right side of strap 3310) extending continuously from the first portion (fig. 17, shows the left and right sides of strap 3310 as continuous) and configured to engage a back of a patient’s head (fig. 17, rear headgear strap 3310 passes around the back of the patient’s head, see [0173]), but does not expressly disclose that the first end, first portion, and the sleeve portion are made from the same material.
However, Veliss teaches of back strap (fig. 10-4) that appears to be integrally formed with a sleeve portion (fig. 10-4, sock S).
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to replace the back strap of the structure of Kooij with the back strap as taught by Veliss as a simple substitution of one known element for another to obtain a predictable result of allowing strap to be adjustable and connected to the sleeve portion.
The modified structure of Kooij reads on the strap includes a first portion (see annotated Veliss fig. 10-4 below) with a first end (see annotated Veliss fig. 10-4 below) fixed to and extending continuously from the sleeve portion (see annotated Veliss fig. 10-4 below) and a second portion extending continuously from the first portion (see annotated Veliss fig. 10-4 below, where the second portion is the portion with the snap fit connectors) and configured to engage a back of a patient's head (Veliss fig. 10-4 shows the strap engaging the back of the patients head), in use, and wherein the first end, the first portion and the sleeve portion are made from the same material (Veliss [0185] states that cover S has a two tone color scheme where the material, colors D and L, extend to the designated first portion, see annotated Veliss fig. 10-4 below).
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10. Claim(s) 65 and 67 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kooij in view of Vandine (US 2008/0060654).
Regarding claim 65, the structure of Kooij discloses the limitations of claim 64 and further discloses that the elastic sleeve can use various connection methods to be secured to the tubes ([0339]), but is silent on the first side is provided with a plurality of first loops and the second side is provided with a plurality of second loops, wherein the elasticate cord extends through a plurality of the first loops and a plurality of the second loops.
However, Vandine discloses a securing system (fig. 2, 20) made of an elastic mesh weave together ([0023]).
Therefore, 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 provide the opening of Kooij with an elastic mesh as taught by Vandine 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 transparent material provides an advantage, is used for a particular purpose, or solves a stated problem. It appears modified device of Kooij would perform equally well with an elastic mesh for allowing the viewing of the underlying tubes.
The modified structure of Kooij reads on the first side is provided with a plurality of first loops (Vandine [0023] the weave connections on the left can be considered first loops) and the second side is provided with a plurality of second loops (Vandine [0023] the weave connections on the right can be considered second loops), wherein the elasticate cord extends through a plurality of the first loops and a plurality of the second loops (Vandine [0023] states the filaments are elastic thereby functioning as an elasticate cord which interlocks with the loops due to the weaved form).
Regarding claim 67, the modified structure of Kooij discloses the limitations of claim 62 and further teaches the window portion comprising a transparent material (Vandine [0023] states interstices 44 form between filaments which allows vision through the elastic mesh).
Response to Arguments
11. Applicant’s arguments with respect to claim(s) 45-67 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.
12. Applicant's arguments filed 03/12/2026 have been fully considered but they are not persuasive.
Applicant argues, see paragraph 6 of page 8 of Remarks, that the straps 3310 of Kooij form part of the conduit headgear tubes and are not part of the sleeves. The rejection to claim 45 above has been updated to clarify that the patient contacting member is considered the sleeves 3340 and strap 3310 which contact the patient in fig. 17 of Kooij. Further, the strap 3310 of Kooij is directly connected to sleeve 3340 of Kooij, see the rejection to amended claim 45 above, and can be considered together to be a patient contacting member.
Applicant argues, see paragraph 7 of page 8 of Remarks, that the amended claim 45 is not anticipated by Kooij because dependent claim 49 recites a portion of the subject matter. However, claim 49 recites in lines 1-2 “the strap is formed integrally with the elongate sleeve portion” while the amended claim 45 recites in lines 4-5 “a strap directly connected or integrally formed with the elongate sleeve portion.” The structure of Kooij (fig. 17) shows the strap 3310 connected to sleeves 3340 thereby reading on “a strap directly connected or integrally formed with the elongate sleeve,” see the updated rejection to claim 45 above.
Applicant argues, see paragraphs 11-12 of page 8 through paragraph 1 of page 9 of Remarks, that Veliss fig. 10-4 shows a sock that covers tubes and can enclose a back strap according to paragraph [0178] of Kooij. However, the portion of the sock of Veliss covering an internal back strap can still be considered a back strap as it is still functioning to secure the device to the head of the patient. Further, Veliss states in [0146] that the tubes and back strap can be co-molded to a rigidizing element, and Veliss [0179] states that a fabric can be co-molded with the silicone to create a one-piece tube where the connection between the back strap, tubes, and outer fabric would similarly read on a strap directly connected to or integrally formed with the elongate sleeve.
Conclusion
13. The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Hashemieh (US 2011/0203595) discloses a connecting strap that extends behind a patient’s head that also forms a sleeve around a nasal cannula.
14. 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.
15. 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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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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