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
The amendments filed 4/23/2026 have been entered. Accordingly, claims 21-42 are pending in the current application.
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.
Claim 38 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. Due to the presence of the term “or” in line 5 of claim 36, from which claim 3 depends upon, claim 38 is indefinite because it further limits an optional limitation. Specifically, claim 38 further limits the structure of the “second strap portion”, however claim 36 recites the limitation of “component or second strap portion”, therefore claim 38 further limits an optional limitation. For the purpose of examination, the examiner will interpret this limitation to be met as long as the prior art teaches the remainder of the recited limitations not involving the term “second strap portion”.
Response to Arguments
Applicant's arguments filed 4/23/2026 have been fully considered but they are not persuasive.
Regarding the 112b rejection previously set forth in the non-final office action regarding claim 38, although Applicant states amendments were made to claim 38 to address the asserted issue, the Examiner notes the amendments made to claim 38 have not addressed the 112b issue previously presented. Claim 38 was rejected under 112b due to the further limiting of an optional limitation, in this case, the “second strap portion”. Claim 36, from which claim 38 is dependent upon, recites the limitation of “component or second strap portion”, therefore due to the presence of the term “or” in claim 36, a second strap portion is not positively recited and/or required by the claim. However, claim 38 contains limitations that further limit the “second strap portion”, therefore further limiting an optional limitation.
Regarding claim 21, Applicant argues on pages 5-6 of the remarks that one of ordinary skill in the art would have not equated Berthon-Jones’ adjustment arrangement as a “worm gear device”, further stating one skilled in the art would not interpret the threaded fastener 628 as a worm screw at least because the threaded fastener is internally threaded. The Examiner respectfully disagrees, first noting that Berthon-Jones’ threaded adjustment member 626 was the element in which was relied upon as the “screw having a shaft with a helical thread”, and not just the threaded fastener 628. Furthermore, the Examiner notes the structural similarities between Applicant’s adjustment mechanism as shown in Figure 59 – comprising a shaft with a helical thread as element 2164, that interfaces with a rotatable dial 2168 – to Berton Jones’ adjustment mechanism as shown in Figure 19 – also comprising a shaft with a helical thread as element 626, interfacing with a rotatable fastener 628.
Regarding claim 23, Applicant argues on page 7 of the remarks that Berton-Jones does not teach the newly added limitation of “the helical thread of the first adjustment mechanism is located on an external surface of the shaft”, stating that the threaded fastener 628 is internally threaded. The Examiner again notes that the externally threaded adjustment member 626 is the structural element of Berthon-Jones’ being relied upon for the shaft, and therefore the Examiner maintains Berthon-Jones’ adjustment mechanism reads on the newly added limitation. Similarly, regarding claim 26, Applicant argues on page 7 that Berthon-Jones’ adjustment mechanism does not teach “an external continuous helical thread”. The Examiner again notes that the externally threaded adjustment member 626 is the structural element of Berthon-Jones’ being relied upon for the shaft, wherein the adjustment member 626 is shown as having an externally threaded helical thread.
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.
Claim(s) 21-22, 24-40 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Berthon-Jones et al. (US 2014/0000619 A1).
Regarding claim 21, Berthon-Jones discloses a headgear assembly for a respiratory mask comprising (headgear assembly 600 for a respiratory mask 800, Figures 15-16 and Paragraph 0067): a plurality of straps comprising a first front strap and a second front strap (headgear assembly comprises a plurality of straps including horizontal strap portions 608, 610, Paragraph 0067 and Figures 15-16); a mask frame (mask frame 700, Figures 15-16 and Paragraph 0071), comprising a first side arm and a second side arm (mask frame 700 may include a pair of horizontally opposing connecting arms 718 comprising a first and second arm portions 720, 722, Paragraph 0073 and Figure 19), the first side arm and the second side arm extending rearwardly (see first and second arm portions 720, 722 of mask frame 700 extending reward, Figure 19); a first adjustment mechanism associated with the first front strap and the first side arm (the anterior ends 612 of the first and second horizontal strap portions 608 and 610 are adjustably connected to the first and second arm portions 720, 722 of the frame 700 via a threaded adjusting member 626 and threaded fastener 628, Paragraph 0069 and Figure 19); and a second adjustment mechanism associated with the second front strap and the second side arm (the anterior ends 612 of the first and second horizontal strap portions 608 and 610 are adjustably connected to the first and second arm portions 720, 722 of the frame 700 via a threaded adjusting member 626 and threaded fastener 628, with the threaded adjusting member 626 disposed on both sides of the headgear, therefore comprising a first and second adjusting mechanism, Paragraph 0069 and Figure 19); wherein the first adjustment mechanism and the second adjustment mechanism each comprise a worm gear device comprising a screw having a shaft with a helical thread (the threaded adjustment member 626 and the threaded fastener 628, Figure 19 and Paragraph 0069).
Regarding claim 22, Berthon-Jones further discloses wherein the first adjustment mechanism comprises a first housing configured to receive the first front strap and the first side arm (see housing structure surrounding the adjustment mechanism as shown in Figure 17, wherein the housing receives the first strap 610 as the adjustment member 626 is integrally formed with the strap 610, as well as the arm portion 722, Figure 19), wherein the second adjustment mechanism comprises a second housing configured to receive the second front strap and the second side arm (adjustment mechanisms disposed on both sides of headgear assembly, Figure 19).
Regarding claim 24, Berthon-Jones further discloses wherein rotation of the screw of the first adjustment mechanism in a first direction moves the headgear assembly closer to the respiratory mask, wherein rotation of the first adjustment mechanism in a second direction moves the headgear assembly away from the respiratory mask (rotation of the threaded fastener 628 comprising head 630 causes either advancement or retraction of the fastener 628 along the adjustment member 626 to thereby adjust the position of the frame 700 relative to the patient’s head, Paragraph 0069).
Regarding claim 25, Berthon-Jones further discloses wherein the first adjustment mechanism connects the first front strap and the first side arm wherein the second adjustment mechanism connects the second front strap and the second side arm (threaded adjustment members 626 connects the straps 608, 610 with the first and second arm portions 722, 720, Figure 19).
Regarding claim 26, Berthon-Jones discloses a headgear assembly for a respiratory mask (headgear assembly 600 for a respiratory mask 800, Figures 15-16 and Paragraph 0067) comprising: a first strap portion (headgear assembly comprises a plurality of straps including horizontal strap portions 608, 610, Paragraph 0067 and Figures 15-16); and an adjustment mechanism comprising a threaded member having an external continuous thread (the anterior ends 612 of the first and second horizontal strap portions 608 and 610 are adjustably connected to the first and second arm portions 720, 722 of the frame 700 via an externally threaded adjusting member 626 and threaded fastener 628, Paragraph 0069 and Figure 19), wherein the adjustment mechanism is configured to connect the first strap portion to a component (threaded adjustment member 626 configured to connect horizontal strap portions 608, 610 with first and second arm portions 720, 722 of mask frame 700, the first and second arm portions being the “component”, Figure 19 and Paragraph 0069; the Examiner notes due to the presence of the term “or” in line 4 of this claim, the limitation of “a second strap portion” is not required by the claim).
Regarding claim 27, Berthon-Jones further discloses wherein the first strap portion is a portion of a first strap and the second strap portion is a portion of a second strap (see first and second strap portions 608, 610, Figure 19).
Regarding claim 28, Berthon-Jones further discloses wherein the component is a mask frame or a strap connector hub (adjustment mechanism 626 connected to the first and second arm portions 720, 722 of the mask frame 700, Figure 19 and Paragraph 0069).
Regarding claim 29, Berthon-Jones further discloses wherein the component (frame 700 comprising first and second arms 720, 722, Figure 19) comprises a threaded aperture configured to engage the threaded member of the adjustment mechanism (first and second arms 720, 722 comprising a connecting portion 702 with a threaded opening to engage with the threaded adjusting member 626, Figure 17 and Paragraph 0069; the Examiner notes due to the presence of the term “or”, the limitation of “a second strap portion” is not required by the claim).
Regarding claim 30, Berthon-Jones further discloses wherein rotation of the threaded member in a first direction moves the first strap portion toward the component, wherein rotation of the threaded member in a second direction moves the first strap portion away from the component (rotation of the threaded fastener 628 comprising head 630 causes either advancement or retraction of the fastener 628 along the adjustment member 626 to thereby adjust the position of the frame 700 relative to the patient’s head, Paragraph 0069; the Examiner notes due to the presence of the term “or”, the limitation of “a second strap portion” is not required by the claim).
Regarding claim 31, Berthon-Jones further discloses wherein the threaded member of the adjustment mechanism is carried by the first strap portion (threaded fastener 628 is supported by the threaded member 626, which may be integrally formed with the strap 610, Figure 19 and Paragraph 0069).
Regarding claim 32, Berthon-Jones further discloses wherein the threaded member extends through the first strap portion to a dial (threaded fastener 628 is supported by the threaded member 626, which may be integrally formed with the strap 610, Figure 19 and Paragraph 0069, with the threaded member extending to a dial 640, Figure 17).
Regarding claim 33, Berthon-Jones further discloses wherein the dial is inset in the first strap portion (see dial 630 inset the first strap portion, Figure 19).
Regarding claim 34, Berthon-Jones further discloses wherein the dial is located at an end of the first strap portion (see dial 630 disposed at the end of strap portion 610, Figure 19).
Regarding claim 35, Berthon-Jones further discloses wherein the dial is coupled to the threaded member such that a user can rotate the dial to rotate the threaded member to adjust a length of the first strap portion (dial 630 is coupled to threaded fastener 628 such that rotation of the threaded fastener 628 comprising head 630 causes either advancement or retraction of the fastener 628 along the adjustment member 626 to thereby adjust the position of the frame 700 relative to the patient’s head, Paragraph 0069).
Regarding claim 36, Berthon-Jones further discloses wherein the threaded member comprises a first enlarged end (see threaded adjustment member 626 having a first enlarged end, annotated Figure 19 below) and the threaded aperture comprises a second enlarged end (see member 702 comprising the threaded opening having a second enlarged end, annotated Figure 19 below), wherein the first enlarged end limits axial movement of the threaded member relative to the first strap portion (the first enlarged end as shown in annotated Figure 19 is the juncture between the threaded member 626 and the strap 610, therefore limits axial movement of the member 626 relative to strap 610), wherein the second enlarged end limits axial movement of the threaded aperture relative to the component (the second enlarged end s shown in annotated Figure 19 limits the axial movement of the opening relative to the mask frame 700; the Examiner notes due to the presence of the term “or”, the limitation of “a second strap portion” is not required by the claim).
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Regarding claim 37, Berthon-Jones further discloses wherein the first enlarged end secures the threaded member in a fixed position relative to the first strap portion (the first enlarged end as shown in annotated Figure 19 is the juncture between the threaded member 626 and the strap 610, therefore secures the member 626 in a fixed positive relative to strap 610).
Regarding claim 38, Berthon-Jones further discloses wherein the adjustment mechanism is configured to connect the first strap portion to the second strap portion (the Examiner notes the 112b rejection presented above; however notes Berthon-Jones’ adjustment member 626 is configured to connect various strap portions of the overall device, Figure 19) the second enlarged end is located within an elongate passage defined within an interior of the second strap portion (see second enlarged end located with the elongated column 702, annotated Figure 19 as shown above; the Examiner notes the 112b rejection regarding this limitation as presented above).
Regarding claim 39, Berthon-Jones further discloses wherein the second enlarged end prevents separation of the threaded member and the component (the second enlarged end prevents separation of the threaded member 626 and the frame 700 as it secures the two components together, Figure 19).
Regarding claim 40, Berthon-Jones further discloses wherein the adjustment mechanism provides fine length adjustment of the first strap portion or of the headgear assembly (rotation of the threaded fastener 628 comprising head 630 causes either advancement or retraction of the fastener 628 along the adjustment member 626 to thereby adjust the position of the frame 700 relative to the patient’s head, Paragraph 0069).
Allowable Subject Matter
Claims 23 and 41-42 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Regarding claim 23, and 41-42, these claims are directed towards the first front strap comprising a plurality of notches, wherein the helical thread of the first adjustment mechanism is located on an external surface of the shaft, and configured to engage the plurality of notches on the first strap portion, wherein each of the plurality of notches extends through a thickness of a respective one of the first front strap and the second front strap, such that the entirety of the screw is located on a side of the respective one of the first front strap and the second front strap. Although Berthon-Jones teaches an adjustment mechanism comprising an externally threaded shaft (adjustment member 626), Berthon-Jones does not teach or suggest motivation for the externally threaded shaft to engage with a plurality of notches disposed on a first front strap portion, such that the adjustment mechanism is configured to connect the first and seconds strap portions. Therefore, a radical structural modification of Berthon-Jones head gear assembly would be needed in order to achieve the structure as claimed in claims 23, and 41-42.
Conclusion
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARAH B LEDERER whose telephone number is 571-272-7274. The examiner can normally be reached on Monday - Friday, 7:30 AM - 4:30 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, Brandy Lee can be reached on (571)-270-7410. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SARAH B LEDERER/Examiner, Art Unit 3785
/MARGARET M LUARCA/Primary Examiner, Art Unit 3785
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