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 responsive to the amendment filed on February 23, 2025. As directed by the amendment: claims 53, 54, 63, and 67 have been amended, claims 1-52 have been canceled, and no new claims have been added. Thus, claims 53-72 are presently pending in the application.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier.
Such claim limitation(s) is/are:
“an adjustment member” in claims 54-72, interpreted in accordance with any of the embodiments of adjustment member 3370 in Figs. 5-17 and 20A-30C, and equivalents thereof.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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 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.
Claims 53, 54, and 62 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Kooij et al. (US 2019/0022343).
As to claim 53, Kooij discloses a positioning and stabilising structure 3300 (Fig. 3A-3E) to provide a force to hold a seal- forming structure 3100 in a therapeutically effective position on a patient's head, the seal-forming structure 3100 constructed and arranged to form a seal with a region of the patient's face surrounding an entrance to the patient's airways for sealed delivery of a flow of air at a therapeutic pressure of at least 6 cmH20 above ambient air pressure to at least the patient's nares throughout the patient's respiratory cycle in use (paragraphs [0132]-[0133],[0068]), the positioning and stabilising structure comprising:
a gas delivery tube 3350 to receive the flow of air from a connection port 3600 on top of the patient's head and to deliver the flow of air to the entrance of the patient's airways via the seal-forming structure 3100, 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 (see Fig. 3A-3E, paragraphs [0152],[0155]),
the gas delivery tube 3350 (show generally in Figs. 3A-3E, but having the form described in Fig. 13 embodiment) further comprising a first portion (the left less stretchable section 3354 shown in Fig. 13), a second portion (the right less stretchable section 3354 shown in Fig. 13), and a variable length portion (the relatively stretchable section 3355) between the first and second portions 3354 which is extendible and/or compressible (see Fig. 13, paragraph [0256]),
the positioning and stabilising structure further comprising an adjustment means 3356 (securing mechanism 3356, see Fig. 13) which is attached or attachable to the first portion 3354 of the gas delivery tube 3350 and is attached or attachable to the second portion 3354 of the gas delivery tube 3350, wherein the connection between the adjustment means 3356 and the gas delivery tube 3350 is adapted to be varied to thereby adjust the length of the variable length portion 3355 (see Fig. 13, paragraph [0256]).
As to claim 54, Kooij discloses a positioning and stabilising structure 3300 (Figs. 3A-3E) to provide a force to hold a seal- forming structure 3100 in a therapeutically effective position on a patient's head, 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 for sealed delivery of a flow of air at a therapeutic pressure of at least 6 cmH20 above ambient air pressure to at least the patient's nares throughout the patient's respiratory cycle in use (paragraphs [0132]-[0133],[0068]), the positioning and stabilising structure 3300 comprising:
a gas delivery tube 3350 to receive the flow of air from a connection port 3600 on top of the patient's head and to deliver the flow of air to the entrance of the patient's airways via the seal-forming structure 3100, 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 (see Fig. 3A-3E, paragraphs [0152],[0155]),,
the gas delivery tube (show generally in Figs. 3A-3E, but having the form described in Fig. 13 embodiment) further comprising a first portion (the top right less stretchable section 3354 shown in Fig. 13), a second portion (the bottom left less stretchable section 3354 shown in Fig. 13), and a variable length portion (the relatively stretchable section 3355 shown in Fig. 13) between the first 3354 and second portions 3354 which is extendible and/or compressible (see Fig. 13, paragraph [0256]), the variable length portion 3355 being integrally formed with the first and second portions 3354 (see Fig. 13, paragraphs [0255]-[0256], portion 3355 is just a more stretchable portion of tube 3350 and portions 3354 are less stretchable sections of the same tube 3350), wherein a plurality of spaced apart attachment means (openings in securing member 3358 of Fig. 13) protrude from a surface of the second portion (see Fig. 13, the walls of each opening in securing member 3358 protrude from the left tube section 3354, when the securing member 3358 is mounted to left section 3354, paragraph [0256]),
the positioning and stabilising structure 3300 further comprising an adjustment member (3357 of Fig. 13) which is attached or attachable to the first portion 3354 of the gas delivery tube 3350 (paragraph [0256]: first securing member 3357 is mounted on a length of tube 3350 on one side of the stretchable section 3355) and is attachable to the second portion of the gas delivery tube 3350 at a selected one of the attachment means 3358 (at one of the plurality of openings on 3358) to thereby adjust the length of the variable length portion 3355 (see Fig. 13, paragraph [0256]: securing member 3358 may comprise a plurality of sites at which the other securing member 3357 may connect to it to allow the tube 3350 to be secured at the desired length).
As to claim 62, modified Kooij discloses the positioning and stabilising structure of claim 54, wherein the adjustment member 3357 extends, in use, over the top of the patient's head (see Fig. 7A showing an adjustable section of tubing on the top of the head).
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 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.
Claims 55 and 56 are rejected under 35 U.S.C. 103 as being unpatentable over Kooij et al. (US 2019/0022343), in view of Rummery et al. (WO 2009/052560).
As to claim 55, modified Kooij discloses the positioning and stabilizing structure of claim 54 (relying on the Fig. 13 embodiment) but does not disclose that each attachment means (openings in securing member 3358) comprises a projecting portion adapted to engage an aperture in the adjustment member 3357 (Fig. 13).
However, Rummery teaches a positioning and stabilizing structure including an securing mechanism (Fig. 25F) for adjustably securing two strap portions 74r, 74l together, the adjustment mechanism having a plurality of attachment means each comprising a projecting portion (studs 74m on strap 74r) that selectively engages a corresponding aperture associated with the strap portion 74l (the spaces between studs 74m on strap 74l, Fig. 25f, paragraph [00237]).
Therefore, it would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to modify the securing mechanism 3356 (Fig. 13) of Kooij so that each attachment means on the second portion is in the form of a projection/stud 74m (Fig. 25f of Rummery) adapted to engage a corresponding aperture/space between two studs 74m of the first portion, as taught by Rummery, in order to provide an equally suitable type of securing mechanism that accomplishes the same result of securing the two portions in a selected one of a plurality of positions.
As to claim 56, modified Kooij discloses the positioning and stabilising structure of claim 55 wherein the attachment means comprise mushroom connectors (studs 74m on portion 74r, see Fig. 25f of Rummery, paragraph [00237]).
Allowable Subject Matter
Claims 57-61 and 63-67 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.
Claims 68-72 are allowed.
Response to Arguments
Applicant's arguments filed February 23, 2026 have been fully considered but they are not persuasive.
As to claim 53, Applicant argues on pages 7-9 of the remarks that the Fig. 13 embodiment of Kooij “does not disclose the feature "the connection between the adjustment means and the gas delivery tube can be varied to thereby adjust the length of the variable length portion". Rather, it is the effective length of the securing mechanism 3356 itself which changes.”
However, the argument is not well taken because Kooij recites:
[0256] FIG. 13 illustrates a headgear tube 3350 having a relatively stretchable section of tube 3355 connected to one or more non- or less stretchable sections of tube 3354. A securing mechanism 3356 may be provided to hold the tube 3350 in position when the desired length is attained. Securing mechanism 3356 may comprise a first securing member 3357 mounted on a length of tube 3350 on one side of the stretchable section 3355 and a second securing member 3358 mounted to a length of tube 3350 on the other side of the stretchable section 3355. First and second securing members 3357 and 3358 are configured to connect together by any appropriate mechanism, for example an interlocking clip, magnet connection, hook-and-loop fasteners. One of the securing members 3358 may comprise a plurality of sites at which the other securing member 3357 may connect to it to allow the tube 3350 to be secured at the desired length.
In other words, the length of tube 3350 between the two securing members 3357 and 3358 varies in length by stretching the stretchable section 3355 to a desired length and securing the first and second securing members 3357,3358 together at one of the plurality of sites. When securing member 3357 is in the farthest site on securing member 3358 shown in Fig. 13, the stretchable section 3355 is in its most compressed and shortest state. When securing member 3357 is in the closest site on securing member 3358, the stretchable section 3355 is in its most stretched and longest state. By changing which of the plurality of attachment sites securing member 3357 connects to on securing member 3358, the length of the stretchable section 3355 varies by holding the variable/stretchable section in a more or less stretched state. Thus, the limitation is met and the rejection stands.
As to claim 54, Applicant argues on page 11 of the remarks that the first tube portion 3370 of Fig. 8 of Kooij is clearly formed separately from second portion/variable length portion 3372. Examiner finds the argument persuasive. However, Kooij’s Fig. 13 embodiment still applies to claim 54 as amended because the more and less stretchable sections 3355, 3354 are part of the same tube 3350 and are thus integrally formed. Therefore, the rejection stands.
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 VALERIE L WOODWARD whose telephone number is (571)270-1479. The examiner can normally be reached on Monday - Friday 8:30 am - 4:30 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, KENDRA CARTER can be reached on 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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/VALERIE L WOODWARD/Primary Examiner, Art Unit 3785