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 02/25/2026. As directed by the amendment, claims 2-8, 10-11, 15-17, 19-34, 36-41, 43-53, 56-57, and 60-71 were canceled, claim 1 was amended, and no claims were newly added. Thus, claims 1, 9, 12-14, 18, 35, 42, 54-55, 58-59 and 72-73 are presently pending in this application.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every
feature of the invention specified in the claims. Therefore, the
“a pair of side straps, each of the pair of side straps directly coupled to the user interface patch of a corresponding one of the facial pads and extending along a side of a corresponding cheek of the user” of claim 1 lines 8-10
“a mechanical fastener” and “a complementary mechanical fastener” of claim 1 lines 9 and 11
must be shown or the feature(s) canceled from the claim(s). No new matter should be
entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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 1, 9, 12-14, 18, 35, 42, 54-55, 58-59 and 72-73 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 1 lines 8-9, the term “a pair of side straps, each of the pair of side straps directly coupled to the user interface patch of a corresponding one of the facial pads” is unclear as to how the strap is able to couple directly to the user interface patch. In present application Fig. 2, user interface patch 274 is shown as between dermal patch 272 and facial pad 250. It is unclear how the middle layer user interface patch 274 is able to couple to a strap in any way. There is no form of connection or connector that is distinctly claimed.
Any remaining claims are rejected as being dependent upon a rejected base claim.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 12-14, 18, 58, and 72-73 are rejected under 35 U.S.C. 103 as being unpatentable over Fai et al. (US 2016/0121068; hereinafter referred to solely as “Fai”) in view of Behan (US 4,641,647) and Rose et al. (US 2013/0133646; hereinafter “Rose”).
Regarding claim 1, Fai discloses a patient interface (see Fai patient interface device 300 Fig. 17-18), comprising:
a mask seal body defining a breathing chamber (see Fai sealing assembly 304 with opening 308) and having a user-contacting surface configured to contact a face of a user and surround at least nares of the user (see Fai cushion 305 to seal around the nares);
a pair of facial pads (see Fai distal ends of support frame 340, comprising slots 242).
Fai is silent as to each facial pad of the pair of facial pads configured to connect to an adjustable bonnet on opposing sides of the mask seal body. However, Behan teaches each facial pad of the pair of facial pads (see Behan extensions 6 on each side) configured to connect to an adjustable bonnet on opposing sides of the mask seal body (see Behan head covering 1 and straps 2, where the head covering 1 is connected to extensions 6 by mechanical fasteners straps 2 through openings 5). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the facial pads of Fai with mechanical fastener configuration to connect to a bonnet as taught by Behan so as to provide a more comfortable securement system for the user.
Modified Fai discloses each facial pad of the pair of facial pads comprising: a user interface patch (see Fai slots 242 on the further end of distal ends of bridging portion 340); a pair of side straps, each of the pair of side straps extending along a side of a corresponding cheek of the user (see Fai [0068] “A headgear (not shown) is coupled to the support frame via slots 242”, wherein previously added straps 2 of Behan (in Behan, attaching to extensions 6 via openings 5) attach to the modified Fai using slots 242 as “headgear” would).
Modified Fai is silent as to each of the pair of side straps comprises a mechanical fastener configured to directly and removably connect to the adjustable bonnet, wherein the mechanical fastener is a hook or a loop material configured to directly connect to a complementary mechanical fastener on the adjustable bonnet. However, Rose teaches each of the pair of side straps comprises a mechanical fastener configured to directly and removably connect to the adjustable bonnet (see Rose straps 32A,32B with end portions 56A,56B. Straps 32A,B thread through loops 54A,B on the patient interface and then attach to the helmet 30 via hook connector patch 50), wherein the mechanical fastener is a hook or a loop material configured to directly connect to a complementary mechanical fastener on the adjustable bonnet (see Rose helmet 30 comprising hook connector patch 50, where hook fasteners portions 56A,B are on straps 32A,B). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the straps and bonnet connection of modified Fai with the hook and loop strap to bonnet connection as taught by Rose as this would have been an obvious substitution for one known type of fastening connection for another and would yield predictable results, i.e. fasten the strap to the bonnet.
Modified Fai discloses a pair of bridging portions (see Fai central left and right side portions of support frame 340 that extend the length of support member 302), each bridging portion of the pair of bridging portions connecting the mask seal body and a respective facial pad of the pair of facial pads (see Fai Fig. 17-18 central left and right side portions of support frame 340 extend into distal ends of support frame 340), each bridging portion of the pair of bridging portions comprising a cutout configured to receive a breathing tube (see Fai cutouts in which support member 302 is inserted; support member 302 allows for passage 306 which gets airflow to the patient… support member 302 is analogous to support member 202 described as [0064] “Support member 202 includes an internal passage or lumen 206 that serves as a pathway for the flow of gas to and from the user”),
wherein each bridging portion of the pair of bridging portions has a curved shape in use urging the mask seal body toward the face of the user to create or maintain sealing engagement between the user-contacting surface and the face of the user (see Fai each side of support frame 340, and corresponding parts urge to seal cushion 305 to the face; Field of Invention [0002-3] “a patient interface… provides a stable platform supporting a sealing assembly…”).
Regarding claim 12, modified Fai discloses each of the pair of bridging portions comprises an S-shape as viewed from above (see Fai Fig. 18 each side of support frame 340 creates an S-shape from above).
Regarding claim 13, modified Fai discloses wherein the mask seal body is reinforced (see Fai support member 302 on which sealing assembly 302 is mounted).
Regarding claim 14, modified Fai discloses a reinforcing element (see Fai support member 302), wherein the reinforcing element is at least one of (iii) a hardened interface tube connection attached to the mask seal body (see Fai support member 302 is cylindrical in shape [0072]).
Regarding claim 18, modified Fai discloses the mask seal body is configured to be placed around an alar region of the user (see Fai [0073] “Cushion 305 is sized and configured to seal around the nares of the user”).
Regarding claim 58, modified Fai discloses one or more respiratory tubes configured to deliver gas (see Fai [0011] “a further object of the present invention to provide a system for delivering a flow of gas to a user using the patient interface device described above”… in which any embodiment of the invention use/connect to patient circuit 12, and [0050] “Patient circuit 12 is any device, such as a flexible tubing, that carries the flow of gas from the pressure/flow generator in the pressure support system to the patient interface device”).
Regarding claim 72, modified Fai the adjustable bonnet comprises one or more sections of loop material (see Behan bonnet modified by hook and loop connector patch 50 of Rose), the one or more sections of loop material configured to engage the user interface patch (see Rose patch 50 engage the slots 242 of Fai via straps 2 of Behan, see rejection to claim 1 above).
Regarding claim 73, modified Fai discloses a system comprising:
the patient interface of Claim 1 (see modified Fai rejection to claim 1 above); and
the adjustable bonnet (see rejection to claim 1 above, specifically Behan head covering 1 with straps 2 are adjustable).
Claims 9 and 42 are rejected under 35 U.S.C. 103 as being unpatentable over Fai in view of Behan and Rose as applied to claim 1 above, and further in view of Ho et al. (US 2006/0060200; hereinafter referred to solely as “Ho”).
Regarding claim 9, modified Fai discloses the pair of bridging portions is split into an upper section and a lower section (see Fai central left and right side portions of support frame 340, and corresponding portions of the upper section border closer to the user’s eye, and the lower section border closer to the user’s chin), but is silent as to the upper section and lower section that are separate from one another. However, Ho teaches each of the pair of bridging portions is split into an upper section and a lower section that are separate from one another (see Ho upper strap 82 and lower strap 74). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the upper and lower section of the bridging portion of modified Fai with the upper and lower sections that are separate from one another as taught by Ho as this would have been an obvious substitution for one known type of bridging portion for another and would yield predictable results, i.e. both bridging portions, separated or not, are performing the same function of keeping the interface on the user’s face.
Regarding claim 42, modified Fai discloses the pair of bridging portions, as well as a part similar to one or more hinges (see Fai left and right side portions of support frame 340 portion that curves in S-shaped section; the bending portion able to hinge in order to urge the support frame 340 towards the user’s face). However, even if modified Fai does not explicitly discloses the hinges, Ho teaches the pair of bridging portions comprise one or more hinges (see Ho [0031] Lines 2-5 “This arcuate configuration allows for upper straps 82 and lower straps 74 to easily slide within the eyelet to create a pseudo-hinge or pivot point between headgear assembly 40 and support body 36”). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the portions of the support frame functioning as the bridging portions of modified Fai with the hinges on the bridging portion as taught by Ho so as to provide more flexibility to better urge the interface towards the user’s face.
Claim 35 is rejected under 35 U.S.C. 103 as being unpatentable over Fai in view of Behan and Rose as applied to claim 1 above, and further in view of Weinman (US 2013/0319417).
Regarding claim 35, modified Fai discloses the patient interface of Claim 1, but is silent as to a third facial pad. However, Weinman teaches a patient interface (see Weinman breathing mask 40) comprising a third facial pad configured to engage a forehead of the user above the mask seal body (see Weinman cushion 63) and a third bridging portion connecting the mask seal body and the third facial pad (see Weinman bracket 61). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the patient interface mask seal body of modified Fai with the third facial pad as taught by Weinman so as to provide additional support.
Claims 54-55 are rejected under 35 U.S.C. 103 as being unpatentable over Fai in view of Behan and Rose as applied to claim 1 above, and further in view of Olsen et al. (US 2014/0096774; hereinafter referred to solely as “Olsen”).
Regarding claim 54, modified Fai discloses the mask seal body comprises an upper region (see Fai top of cushion 305, on patient contacting surface 314). Modified Fai is silent as to wherein at least part of the upper region rolls when the mask seal body is positioned on a user's face. However, Olsen teaches a mask seal body (see Olsen mask seal 110) wherein at least part of the upper region rolls when the mask seal body is positioned on a user's face (see Olsen [0103] Lines 1-3 “the upper portion 154 of the mask seal 110 is designed to roll over onto an outer surface 170 of the mask assembly 102”). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the upper region of modified Fai with the upper region that rolls as taught by Olsen so as to allow the cushion to pivot and fit different sized faces.
Regarding claim 55, modified Fai discloses the upper region comprises a portion with a thinner wall located between portions having thicker walls (see Olsen [0104] Lines 2-5 “the upper portion 154 can have a varying thickness or a varying stiffness. In the configuration shown in FIG. 12, the upper portion 154 comprises a thick/thin/thick configuration”).
Claim 59 is rejected under 35 U.S.C. 103 as being unpatentable over Fai in view of Behan and Rose as applied to claim 1 above, and further in view of Martin et al. (10,420,909; hereinafter referred to as “Martin”).
Regarding claim 59, modified Fai is silent as to the one or more respiratory tubes comprise an inspiratory tube configured to deliver gas to the user, and an expiratory tube configured to deliver gas from the user. However, Martin teaches a patient interface (see Martin patient interface 3000) one or more respiratory tubes comprise an inspiratory tube configured to deliver gas to the user (see Martin Fig. 4a inlet limb 3104), and an expiratory tube configured to deliver gas from the user (see Martin Fig. 4b outlet limb 3106 exhalation toward controllable valve 3108). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the respiratory tubes of modified Fai with the specific inspiratory tube and expiratory tube as taught by Martin so as to have more control over respiratory flow.
Response to Arguments
Applicant's arguments filed 02/25/2026 have been fully considered but they are not persuasive.
Applicant argues, on page 6 of the remarks, that “Applicant submits that a person of ordinary skill would understand the claimed "mechanical fastener" and "complementary mechanical fastener" of Claim 1 without requiring further detailed illustrations.” However, Examiner disagrees since the drawing objection clearly states that every feature of the invention specified in the claims must be shown. Therefore, the objection still stands.
Applicant’s arguments with respect to claim 1 have been considered but are moot because the new ground of rejection does not solely rely on the references applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. See modified rejection to claim 1 again for amended language.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GWYNNETH L HOWELL whose telephone number is (703)756-4742. The examiner can normally be reached 8:30-4:30 M-F.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Tim Stanis can be reached on (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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/GWYNNETH L HOWELL/Examiner, Art Unit 3785 /RACHEL T SIPPEL/Primary Examiner, Art Unit 3785