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 Amendments
The Amendment filed 9/30/2025 has been entered. Claims 3, 6, 12, 17-19, 21, and 23 were amended, claims 1-2 and 7 were canceled, and claim 27 was new. Thus, claims 3-6 and 8-27 are pending in the application.
Claim Objections
Claims 17 and 20-21 are objected to because of the following informalities:
Claim 17 recites “the magnetic fastener components on the third strap and the fourth strap” in line 4, and is suggested to read --the third magnetic fastener component on the third strap and the fourth magnetic fastener component on the fourth strap-- in order to more clearly reference how the limitations were originally claimed and to provide clarity.
Claim 20 recites “the textile and/or foam material” in lines 2-3, and is suggested to read --the textile and/or the foam material-- in order to ensure proper antecedent basis.
Claim 21 recites “the two layers” in line 3, and is suggested to read --the at least two layers-- in order to more clearly reference how the limitation was originally claimed.
Appropriate correction is required.
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 is: “magnetic fastener component” in claim 3 lines 5-6, claim 17 lines 2, 3, and 5, and claim 18 line 4.
Because this claim limitation is being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it is being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
According to the Applicant’s specification para. [0190], the “magnetic fastener component” limitation is being interpreted as a magnet or a material that is attracted to or repelled by a magnetic field, or equivalents thereof.
If applicant does not intend to have this limitation 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 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 recites sufficient structure to perform the claimed function so as to avoid it being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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 18 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.
Regarding claim 18, the limitations “a patient interface” in line 2 and “at least one patient interface fastener half” in line 3 are confusing, as it is unclear whether or not these limitations are meant to be the same as or different from “a patient interface” and “at least one corresponding patient interface fastener half” in claim 3, respectively. For the purposes of examination, they will be interpreted as the same respective limitations.
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.
Claims 3-5, 8-11, 13-20, and 27 are rejected under 35 U.S.C. 103 as being unpatentable over Tebbutt et al. (US 2021/0187234 A1) in view of Allan et al. (US 2011/0146685 A1) and Perez (US 2013/0341978 A1).
Regarding claim 3, Tebbutt discloses a positioning and stabilising structure for a patient interface system (headgear assembly for an interface) (Fig. 18; abstract), comprising:
at least one strap (side arms 702 with upper portions 792 and lower portions 794) (Fig. 18; para. [0140]; para. [0143]);
and at least one strap fastener half (upper and lower portions 792, 794 have a structure at connection point 32 to connect to the interface 30, such as a magnet) (Fig. 18; paras. [0142-0143]);
a textile material and/or a foam material of the at least one strap (side arms can include fabric, textile, and/or foam materials) (para. [0167]);
wherein the at least one strap fastener half is configured to, in use, engage with at least one corresponding patient interface fastener half on a patient interface to attach the positioning and stabilising structure to the patient interface (the magnets of upper and lower portions 792, 794 would engage with their corresponding magnets of the patient interface 30 to attach the structures together) (Fig. 18; paras. [0142-0143]).
Tebbutt does not disclose wherein the at least one strap fastener half comprises at least one magnetic fastener component permanently attached directly to a textile material and/or a foam material of the at least one strap.
However, Allan teaches a patient interface (Allan; abstract) including wherein the at least one strap fastener half comprises at least one magnetic fastener component is permanently attached directly to a textile material and/or a foam material of the at least one strap (magnets on straps can include holes to allow the magnets to be stitched directly on the straps, where stitching would effectively permanently attach the magnets and straps; straps can be made of material such as fabric or foam) (Allan; Fig. 47; para. [0539]; paras. [0557-0558]; para. [0579-0580]).
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 Tebbutt at least one strap fastener half such that the at least one strap fastener half comprises at least one magnetic fastener component permanently attached directly to a textile material and/or a foam material of the at least one strap, as taught by Allan, for the purpose of providing the system with a more specific magnetic fastening mechanism which one of ordinary skill in the art could feasibly assume to work reasonably well.
Tebbutt does not teach wherein the at least one of the first strap fastener half comprises an insertion portion configured to, in use, be inserted into a receiving portion of the at least one corresponding patient interface fastener half.
However, Perez teaches a strap assembly (Perez; abstract) wherein the at least one of the first strap fastener half comprises an insertion portion configured to, in use, be inserted into a receiving portion of the at least one corresponding patient interface fastener half (fastener 30 can be a magnetic snap-type fastener made of two portions 32, 34, where one portion 32 has a male projection and the other portion 34 is female to receive the male projection of portion 32) (Perez; Figs. 2-3; para. [0032]).
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 modified Tebbutt system’s strap fastener half such that the at least one of the first strap fastener half comprises an insertion portion configured to, in use, be inserted into a receiving portion of the at least one corresponding patient interface fastener half, as taught by Perez, for the purpose of ensuring the fastener portions or halves stay in proper alignment when attached (Perez; para. [0032]).
Regarding claim 4, the modified Tebbutt teaches wherein the at least one magnetic fastener component comprises a first magnetic fastener component and a second magnetic fastener component (the modified Tebbutt would have Allan magnets for all of the side arm 702 upper portions 792 and lower portions 794) (Tebbutt, Fig. 18, para. [0140], paras. [0142-0143]; Allan, Fig. 47, paras. [0557-0558]), and wherein the at least one strap comprises a first strap and a second strap (both side arm 702 lower portions 794) (Tebbutt; Fig. 18; para. [0140], para. [0143]), and the at least one strap fastener half comprises a first strap fastener half and a second strap fastener half, the first strap fastener half including the first magnetic fastener component and the second strap fastener half including the second magnetic fastener component (both the modified Tebbutt side arm 702 lower portion 794 ends with their respective Allan magnets) (Tebbutt, Fig. 18, para. [0140], para. [0143]; Allan, Fig. 47, paras. [0557-0558]).
Regarding claim 5, the modified Tebbutt teaches wherein the first magnetic fastener component is permanently attached to the first strap, and the second magnetic fastener component is permanently attached to the second strap (Allan magnets sewn into both Tebbutt lower portions 794 so as to be effectively permanently attached) (Tebbutt, Fig. 18, para. [0143]; Allan, Fig. 47, paras. [0557-0558]).
Regarding claim 8, the modified Tebbutt teaches wherein the at least one magnetic fastener component is permanently attached directly to the foam material (when the Tebbutt cover layer of the side arm 702 is made of foam, the Allan magnets would be sewn into the foam so as to be effectively permanently attached) (Tebbutt, Fig. 19, para. [0167]; Allan, Fig. 47, paras. [0557-0558]).
Regarding claim 9, the modified Tebbutt teaches wherein the at least one strap has a multi-layer construction comprising a first layer of material and at least one additional layer of material (side arms can comprise multiple layers of material, such as plastic covered by fabric, textile, or foam) (Tebbutt; para. [0167]).
Regarding claim 10, the modified Tebbutt teaches herein the at least one additional layer of material includes the textile material (side arms can comprise a fabric or textile material) (Tebbutt; para. [0167]).
Regarding claim 11, the modified Tebbutt teaches wherein the first layer of material is the foam material (side arms can comprise foam material) (Tebbutt; para. [0167]).
Regarding claim 13, the modified Tebbutt teaches wherein the at least one strap has a patient contacting surface, and wherein the at least one magnetic fastener component is located on a distal side of the patient contacting surface from the patient's face in use (Tebbutt side arm 702 has a surface facing the patient, and the Allan magnet would be on a distal side of this surface toward the end of the side arm 702 in order to interact with the corresponding magnet on the interface 30) (Tebbutt, Fig. 18, para. [0140], paras. [0142-0143]; Allan, Fig. 47, paras. [0557-0558]).
Regarding claim 14, the modified Tebbutt teaches a third strap and a fourth strap (both upper portions 792) (Tebbutt; Fig. 18; para. [0140]).
Regarding claim 15, the modified Tebbutt teaches wherein the first strap and the second strap are a pair of lower straps of the positioning and stabilising structure (both lower portions 794) (Tebbutt; Fig. 18; para. [0140]; para. [0143]) and the third strap and the fourth strap are a pair of upper straps of the positioning and stabilising structure (both upper portions 792) (Tebbutt; Fig. 18; para. [0140]).
Regarding claims 16-17, the modified Tebbutt teaches wherein the third strap and the fourth strap each comprises a connector configured to in use releasably attach the positioning and stabilising structure to a patient interface; wherein the connector on the third strap includes a third magnetic fastener component and the connector on the fourth strap includes a fourth magnetic fastener component, wherein the magnetic fastener components on the third strap and the fourth strap are configured to be magnetically attracted to corresponding magnetic fastener components on the patient interface (both the modified Tebbutt side arm 702 upper portion 792 ends with their respective Allan magnets that in turn correspond to attract respective magnets on the Tebbutt interface 30 to form a releasable magnetic connection) (Tebbutt, Fig. 18, para. [0140], para. [0142]; Allan, Fig. 47, paras. [0557-0558]).
Regarding claim 18, as best understood, the modified Tebbutt teaches a treatment system, comprising a patient interface to deliver a supply of pressurised breathable gas to one or more of a patient's airways (headgear assembly for an interface, including a supply of pressurized breathable gases to deliver to a patient’s airway) (Tebbutt; Fig. 18; abstract; para. [0053]), the patient interface comprising at least one patient interface fastener half including at least one patient interface magnetic fastener component (magnets on Tebbutt patient interface 30) (Tebbutt, Fig. 18, paras. [0142-0143]; Allan, Fig. 47, paras. [0557-0558]): and the positioning and stabilising structure according to claim 3 (see 35 U.S.C. 103 rejection of claim 3 above), wherein, in use, the at least one magnetic fastener component of the positioning and stabilising structure is configured to be magnetically attracted to the at least one patient interface magnetic fastener component to removably connect the at least one strap to the patient interface (the modified Tebbutt side arm 702 upper and lower portions 792, 794 have Allan magnets that in turn correspond to attract respective magnets on the Tebbutt interface 30 to form a releasable magnetic connection) (Tebbutt, Fig. 18, paras. [0143-0142]; Allan, Fig. 47, paras. [0557-0558]).
Regarding claim 19, Tebbutt discloses a method of manufacturing a positioning and stabilising structure for a patient interface system (manufacture and assembly of a headgear assembly for an interface) (Fig. 18; abstract; para. [0049]), the method comprising:
selecting a first layer of material of a headgear strap (side arms 702 can include fabric, textile, and/or foam materials) (Fig. 18; para. [0167]):
providing a strap fastener half comprising a magnetic fastener component (upper and lower portions 792, 794 have a structure at connection point 32 to connect to the interface 30, such as a magnet) (Fig. 18; paras. [0142-0143]),
positioning the magnetic fastener component and the first layer of material relative to each other (the material of the side arm 702 upper portions 792 and lower portions 794 would be positioned relative to a magnet for fastening the upper and lower portions 792, 794 to interface 30) (Fig. 18; paras. [0142-0143]);
wherein the first layer of material of the headgear strap comprises a textile material and/or a foam material (side arms 702 can include fabric, textile, and/or foam materials) (Fig. 18; para. [0167]),
wherein the strap fastener half is configured to, in use, engage with a corresponding patient interface fastener half on a patient interface to attach the positioning and stabilizing structure to the patient interface (the magnets of upper and lower portions 792, 794 would engage with their corresponding magnets of the patient interface 30 to attach the structures together) (Fig. 18; paras. [0142-0143]).
Tebbutt does not disclose permanently attaching the magnetic fastener component directly to the first layer of material of the headgear strap.
However, Allan teaches a patient interface (Allan; abstract) including permanently attaching the magnetic fastener component directly to the first layer of material of the headgear strap (magnets on straps can include holes to allow the magnets to be stitched directly on the straps, where stitching would effectively permanently attach the magnets and straps; straps can be made of material such as fabric or foam) (Allan; Fig. 47; para. [0539]; paras. [0557-0558]; para. [0579-0580]).
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 Tebbutt method to include permanently attaching the magnetic fastener component directly to the first layer of material of the headgear strap, as taught by Allan, for the purpose of providing the method with a more specific magnetic fastening mechanism which one of ordinary skill in the art could feasibly assume to work reasonably well.
Tebbutt does not teach wherein the strap fastener half comprises an insertion portion configured to, in use, be inserted into a receiving portion of the corresponding patient interface fastener half.
However, Perez teaches a strap assembly (Perez; abstract) wherein the strap fastener half comprises an insertion portion configured to, in use, be inserted into a receiving portion of the corresponding patient interface fastener half (fastener 30 can be a magnetic snap-type fastener made of two portions 32, 34, where one portion 32 has a male projection and the other portion 34 is female to receive the male projection of portion 32) (Perez; Figs. 2-3; para. [0032]).
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 modified Tebbutt system’s strap fastener half such that the strap fastener half comprises an insertion portion configured to, in use, be inserted into a receiving portion of the corresponding patient interface fastener half, as taught by Perez, for the purpose of ensuring the fastener portions or halves stay in proper alignment when attached (Perez; para. [0032]).
Regarding claim 20, the modified Tebbutt teaches wherein the step of permanently attaching the magnetic fastener component to the textile material and/or foam material involves forming at least a portion of the headgear strap for the positioning and stabilising structure (Tebbutt side arm 702 upper and lower portions 792, 794 were modified to include the Allan magnets with holes for stitching the magnets directly on the straps, where stitching would effectively permanently attach the magnets and straps; the Tebbutt side arm 702 is formed with intra-moulded features) (Tebbutt, Fig. 18, para. [0140], para. [0167]; Allan, Fig. 47, paras. [0557-0558]).
Regarding claim 27, the modified Tebbutt teaches wherein the at least one strap is configured to be in tension in use and when the positioning and stabilising structure is attached to the patient interface (as upper and lower portions 792, 794 are held between straps 712, 714 and patient interface 30 at fixed connection points 32, 798 to apply a sealing force, there would be a tension force through the upper and lower portions 792, 794) (Tebbutt; Fig. 18; para. [0144]).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Tebbutt in view of Allan and Perez as applied to claim 4 above, and further in view of Hocking et al. (US 2019/0175863 A1), or alternatively over Tebbutt in view of Allan and Perez as applied to claim 4 above, and further in view of Hasegawa (US 2021/0322705 A1).
Regarding claim 6, the modified Tebbutt teaches the invention as previously claimed, but does not teach wherein a portion of the at least one magnetic fastener component is embedded in the at least one strap.
However, Hocking teaches a respiratory interface (Hocking; abstract) wherein a portion of the at least one magnetic fastener component is embedded in the at least one strap (protrusion 541 having a magnet embedded in the strap; apertures 543 having small annular magnets embedded in the strap) (Hocking; Fig. 16A; para. [0159]).
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 modified Tebbutt by substituting out sewing for embedding as a means of permanent attachment for the at least one magnetic fastener component, such that a portion of the at least one magnetic fastener component is embedded in the at least one strap, as taught by Hocking, for the purpose of providing the fastener component with an alternate means of being permanently secured to the strap which one of ordinary skill in the art could reasonably expect to perform similarly well.
As another alternative, Hasegawa teaches a face covering apparatus with cloth and magnets (Hasegawa; abstract) wherein a portion of the at least one magnetic fastener component is embedded in the textile material (magnets 206 embedded and/or stitched into cloth 204) (Hasegawa; Fig. 2A; para. [0042]).
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 modified Tebbutt by including Hasegawa embedding to the Allan stitching/sewing means of attachment for the at least one magnetic fastener component, such that a portion of the at least one magnetic fastener component is embedded in the textile material, as taught by Hasegawa, for the purpose of providing an additional securing mechanism to the at least one magnetic fastener component, thereby helping to ensure at least one magnetic fastener component is more securely fastened to the textile material.
With this modification, the modified Tebbutt device would thus teach wherein a portion of the at least one magnetic fastener component is embedded in the at least one strap (Allan magnets would be stitched, as taught by Allan, and embedded, as taught by Hasegawa, in the Tebbutt textile/foam cover layer of the side arms 792, 794) (Tebbutt, Fig. 18, para. [0167]; Allan, Fig. 47, paras. [0557-0558]; Hasegawa, Fig. 2A, para. [0042]).
Claims 12 and 21-22 are rejected under 35 U.S.C. 103 as being unpatentable over Tebbutt in view of Allan and Perez as applied to claims 10 and 20 above, and further in view of Amarasinghe et al. (US 2018/0250486 A1).
Regarding claim 12, the modified Tebbutt teaches the invention as previously claimed, but does not teach wherein the first layer of material and the at least one additional layer of material of the multi-layer construction are laminated or glued together.
However, Amarasinghe teaches a patient interface (Amarasinghe; abstract) wherein the first layer of material and the at least one additional layer of material of the multi-layer construction comprises a plurality of layers (foam and tactile layer glued or laminated together over the arm) (Amarasinghe; para. [0271]).
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 Tebbutt multi-layered construction such that the first layer of material and the at least one additional layer of material of the multi-layer construction are laminated or glued together, as taught by Amarasinghe, for the purpose of providing the arm or headgear strap with materials to enhance patient comfort, absorb compressive forces, conform to facial profile variations, and provide a desirable tactile feel (Amarasinghe; para. [0269]), and which should not alter the shape and rigidity of the arms or headgear straps (Amarasinghe; para. [0271]).
Regarding claim 21, the modified Tebbutt teaches wherein forming the headgear strap involves laminating at least two layers of material to each other to form a multi-layer structure, the two layers of material including the textile material and/or the foam material (foam and tactile layer laminated together over the arm) (Amarasinghe; para. [0271]).
Regarding claim 22, the modified Tebbutt teaches wherein laminating the at least two layers of material to each other permanently attaches the magnetic fastener component to the headgear strap (Tebbutt was modified by Allan to have a magnet directly stitched to a Tebbutt side arm 702 upper portion 792 and lower portion 794 material; the addition of Amarasinghe layers laminated on top of the modified Tebbutt side arm 702 would further effectively permanently attach the Allan magnet to the Tebbutt side arm 702) (Tebbutt, Fig. 18; Allan, Fig. 47, paras. [0557-0558]; Amarasinghe, para. [0271]).
Claims 23-26 are rejected under 35 U.S.C. 103 as being unpatentable over Tebbutt in view of Allan and Perez as applied to claim 19 above, and further in view of Freestone et al. (US 2018/0207385 A1).
Regarding claims 23-24, the modified Tebbutt teaches the invention as previously claimed, but does not teach including a step of shaping the headgear strap to have a predetermined shape, wherein the step of shaping the headgear strap includes cutting.
However, Freestone teaches a headgear assembly for retaining a respiratory mask (Freestone; abstract) including a step of shaping the headgear strap to have a predetermined shape, wherein the step of shaping the headgear strap includes cutting (the components that make up the headgear assembly can be trimmed to size for a user’s measurements via cutting) (Freestone; paras. [0285-0286]).
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 Tebbutt method to include a step of shaping the headgear strap to have a predetermined shape, wherein the step of shaping the headgear strap includes cutting, as taught by Freestone, for the purpose of providing an individual fit for a user (Freestone; para. [0286]).
Regarding claims 25-26, the modified Tebbutt teaches another component of the positioning and stabilising structure (top strap 712, rear strap 714, and/or chin strap 710) (Tebbutt; Fig. 18; para. [0140]), but does not teach including a step of attaching the headgear strap to another component of the positioning and stabilising structure, wherein the step of attaching the headgear strap to another component involves sewing to create a joint.
However, Freestone further teaches a step of attaching the headgear strap to another component of the positioning and stabilising structure, wherein the step of attaching the headgear strap to another component involves sewing to create a joint (components of the headgear assembly can be attached to one another via sewing) (Freestone; para. [0285]).
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 Tebbutt method to include a step of attaching the headgear strap to another component of the positioning and stabilising structure, wherein the step of attaching the headgear strap to another component involves sewing to create a joint, as taught by Freestone, for the purpose of providing a suitable manner in which to attach headgear assembly components (Freestone; para. [0285]) which one of ordinary skill in the art could feasibly expect to perform reasonably well.
Response to Arguments
Applicant's arguments filed 9/30/2025 have been fully considered but they are not persuasive.
On page 8 in the “Drawings” and “Claim Objections” sections of the Applicant’s remarks, the Applicant argues that the drawings and claims have been amended to overcome the objections of the previous office action. The Examiner agrees, and has thus withdrawn those objections. However, the newly amended claims have raised new claim objections as detailed above.
On page 8 in the “Rejections Under 35 U.S.C. 112” section of the Applicant’s remarks, the Applicant argues that the claims have been amended to overcome the 35 U.S.C. 112(b) rejections of the previous office action. The Examiner partially agrees, and has thus withdrawn those rejections which were addressed. However, the unaddressed issues with claim 18 remain rejected under 35 U.S.C. 112(b) as detailed above.
On page 10 in the last paragraph to page 13 in the third paragraph of the Applicant’s remarks, the Applicant argues that the Allan magnetic connectors are intended to be low profile magnets that are weak and easily disconnected with a relatively small tension force, and that stronger larger profile magnets as in the Applicant’s invention would put undue stress on a strap material if stitched directly thereto, and thus Allan teaches away from the Applicant’s claimed invention. However, the Examiner respectfully disagrees. Neither the Applicant’s claimed invention nor the Tebbutt reference recites a particular magnetic strength or profile is required, nor what tension force should be needed to disconnect the magnets. In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., a particular magnetic strength, magnet profile, and/or releasing tension force) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Nevertheless, in Allan, the release tension for the first and second ends of a connector is less than 10N (Allan; para. [0155]), wherein the connector can include engaging magnets (Allan; paras. [0556-0557]). Other references support this magnetic connector release tension as being sufficiently strong for a strap connected to a patient interface. For example, Smith et al. (US 2003/0051732 A1, hereinafter Smith ‘732), teaches a mask (Smith ‘732; Fig. 8; abstract) wherein the preselected tension appropriate for to fix a mask and straps against a patient’s head is between 1 and 10 Newtons (Smith ‘732; para. [0060]). Moreover, Smith et al. (US 2013/0074845 A1, hereinafter Smith ‘845) teaches a patient interface with connecting straps (Smith ‘845; Fig. 13; abstract) wherein each of four straps is under 1.5-15 Newtons of force (Smith ‘845; para. [0305]). Thus, the modification of Tebbutt to include the Allan magnetic fasteners between the straps or side arms and the patient interface would result in straps or side arms capable of holding the patient interface against a patient’s head, and as such the current prior art of record can still be used to teach the Applicant’s claimed invention.
On page 13 in the fourth to sixth paragraphs of the Applicant’s remarks, the Applicant argues that the Tebbutt side arms cannot be modified to be stitched as taught by Allan, as a needle could not pass through both the Tebbutt plastic core and its textile covering to attach a magnet. However, the Examiner respectfully disagrees. A needle for stitching would not need to go through the Tebbutt plastic core in order to attach the Allan magnet to the Tebbutt textile covering, as the Allan magnet could be stitched to the Tebbutt textile covering before it is injected with the plastic core (Tebbutt; para. [0167]). Thus, the current combination of prior art of record can still be used to teach the Applicant’s claimed invention.
On page 13 in the seventh paragraph to page 14 in the sixth paragraph of the Applicant’s remarks, the Applicant argues that the other prior art of Perez, Amarasinghe, and Freestone do not make up for the shortcomings of Tebbutt and Allan as argued above, and thus the Applicant’s invention is allowable. However, the Examiner respectfully disagrees. The Examiner has addressed the Applicant’s arguments and explained how the Tebbutt and Allan references can still be used to teach the Applicant’s claimed invention as discussed above, and does not rely on the other teaching references of Perez, Amarasinghe, and Freestone to make up for the argued shortcomings. Thus, this argument is moot, and the current combination of prior art of record can still be used to teach the Applicant’s claimed invention.
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.
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/JACQUELINE M PINDERSKI/Examiner, Art Unit 3785
/RACHEL T SIPPEL/Primary Examiner, Art Unit 3785