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 .
DETAILED ACTION
This office action is in response to the filing of the application on 08/07/2024. Since the initial filing, no claims have been amended, added, or canceled, Thus, claims 1-19 are pending in the application.
Specification
The title of the invention, “Patient Interface System” is not descriptive. A new title is required that is clearly indicative of the invention to which the claims are directed.
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.
At present, no claims are interpreted under 35 USC 112(f).
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 15 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 15, the term, “relatively easily” is unclear as this is subjective to different people or scenarios. The amount of force applied and whether or not it is considered “relatively easy” to bend is dependent on the person and the strength required from each person attempting to bend the frame body.
Any remaining claims are rejected as being dependent upon a rejected base claim.
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 9 and 12 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding claim 9, the limitation “anterior wall” is not supported by the specification and is not possessed by the applicant. The specification describes multiple embodiments in reference to an “anterior wall” and further discloses that Figures 5A, 9, and 10 would be defined as having a volume of space defined by a plenum chamber and a frame; however, the specification further discloses that these embodiments may not include an anterior wall and is not shown in Figures 9 and 10 which the claims point to ([0162] discloses that the Figures 5A, 9, and 10 have a volume of space defined by the plenum chamber 3200 and the frame 3360 where these embodiments may not have an anterior wall. Fig 9, there is no distinct anterior wall provided between the frame 3360 and the cushion module 6200).
Regarding claim 12, the limitation the “lateral side of the plenum chamber” is not supported by the specification and is not possessed as the claim points to Figures 9 and 10 and further mixing embodiments. The claim discloses the first and second lateral side of the plenum chamber have a first and second plenum chamber inlet port; however, the specification discloses that the embodiments shown Figures 8A and 8B are the embodiments that possess a first and second plenum chamber inlet port on a first and second lateral side of the plenum chamber, not the frame as described in the claim which is directed to Figures 9 and 10 ([0192] discloses that the embodiments shown in Figs 8A and 8B have the first and second plenum chamber inlet ports 3205 on each lateral side of the plenum chamber).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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 1-7, 9-11, 13, 15-19 are rejected under 35 U.S.C. 103 as being unpatentable over Hartono et al (US 2022/0134039 A1).
Regarding claim 1, Hartono discloses a patient interface (Fig. 1C, the patient interface 3000) for use in delivering breathable gas to a patient (Hartono, [0024] discloses the patient interface may be placed on region of the face to facilitate the delivery of gas), the patient interface comprising: a cushion module (Hartono, Fig 59, cushion assembly 3075); and a frame, wherein the cushion module comprises:
a plenum chamber (Hartono, Fig 3A, plenum chamber 3200) pressurisable to a therapeutic pressure of at least 4 cmH2O above ambient air pressure (Hartono, [0080] discloses a plenum chamber is pressurisable to a therapeutic pressure of at least 4cmH2O above ambient air pressure), said plenum chamber forming a plenum chamber inlet port configured to receive a flow of breathable gas at the therapeutic pressure for breathing by the patient (Hartono, [0080] discloses a plenum chamber has a plenum chamber inlet port structured to receive a flow of air at therapeutic pressure for breathing by the patient);
and a seal-forming structure (Hartono, Fig 59, seal-forming structure 3100) provided to the plenum chamber (Hartono, [0282] discloses that the seal-forming structure 3100 is able to form a portion of the plenum chamber 3200), wherein the seal-forming structure is configured to form a seal with a region of the patient’s face surrounding an entrance to the patient’s airways ([0081] discloses the seal-forming structure is configured to form a seal with a region’s of the patient’s face surrounding the entrance to the patient’s airways), said seal-forming structure having an opening therein such that in use the flow of breathable gas is delivered to the entrance to the patient’s airways ([0264] discloses that the naris opening 3102 which are used to provide flow to the seal-forming structure 3100 which allows corresponds to the patient’s naris to inhale. Fig 32, the naris openings in reference to the seal-forming structure 3100), the seal-forming structure being configured to maintain said therapeutic pressure in the plenum chamber throughout the patient’s respiratory cycle in use ([0080] discloses the seal-forming structure has a hole so the flow of air at a therapeutic pressure is delivered to the entrance of the patient’s nares and is constructed to maintain the therapeutic pressure in the plenum chamber throughout the patient’s respiratory cycle in use);
a first cushion module interlock portion on a first lateral side of a non-patient-facing side of the cushion module (Fig 61, the recess 3177 is the first cushion module interlock portion on the first lateral side);
wherein the frame comprises: a frame body (Fig 58, the frame assembly 3500 is the frame body) forming a frame opening (Fig 58, the connecting portion 3540 is the frame opening) allowing the flow of breathable gas to be delivered to the plenum chamber (Fig 58, the cover connecting portion 3540 is configured to connect to the tube portion 3590 which can bring breathable gas to the plenum chamber); two or more headgear connectors for connecting with headgear (Fig 44A, a pair of finger tabs 3345 and 3355 are the end of the first 3340 and second 3350 straps to connect to the headgear 3330), the headgear connectors being positioned on respective lateral sides of the frame body in use ([0353] discloses that the finger tabs 3345 and 3355 are on respective ends of the straps 3340 and 3350 and connect to the rigidiser arms 3302; Fig 58, the rigidiser arms are on each lateral side);
a first frame interlock portion (Fig 61, protrusion 3537 is the first frame interlock portion on a first lateral side of a patient-facing side of the frame body);
wherein the frame and the cushion module are configured to connect together via a first interlock between the first cushion module interlock portion and the first frame interlock portion disconnect (Hartono, [0303] discloses that the cushion connecting portion 3530 to releasably connect to the cushion assembly 3075 to the frame assembly 3500 (Fig 61, the recess 3177 is the first cushion module interlock portion on the first lateral side. Fig 61, protrusion 3537 is the first frame interlock portion on a first lateral side of a patient-facing side of the frame body).
Hartono does not disclose a second cushion module interlock portion on a second lateral side of the non-patient-facing side of the cushion module and a second frame interlock portion on a second lateral side of the patient-facing side of the frame body. Hartono further does not disclose a second interlock between the second cushion module interlock portion and the second frame interlock portion which is configured to interlock to one another. Hartono also does not disclose wherein the frame is configured to flex to alter a distance between the first frame interlock portion and the second frame interlock portion, and wherein flexing the frame to increase the distance between the first frame interlock portion and the second frame interlock portion enables the cushion module to disconnect from the frame.
However, Hartono discloses a similar embodiment (Fig 16 to Fig 18) in the same reference of a patient interface system with a cushion assembly and frame assembly configured to releasably connect and disconnect (Hartono, [0303] discloses that the cushion connecting portion 3530 to releasably connect to the cushion assembly 3075 to the frame assembly 3500) to each other (Hartono, Fig 16, 17, and 18, the cushion assembly 3075 and the frame assembly 3500). Hartono further discloses that the frame assembly includes one or more protrusions and corresponding recesses which are placed along the frame connecting portion in order to help ensure the proper orientation (Hartono, [0317] discloses there can be one or more protrusions 3537 and the corresponding recesses 3177 which can act as an alignment feature).
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 embodiment (Hartono, Fig 59-61) to include another set of protrusions and recesses on the other side to mirror the first set as taught by Hartono’s other embodiment (Hartono, Fig 16-18). Hartono’s embodiment, pertaining to Figures 16 through 18, have a recess that is configured to receive a protrusion to connect the two pieces together (Hartono, [0319] discloses that the cushion connecting portion 3530 of the frame assembly can include a protrusion 3537 on a lateral side of the frame assembly 3500 to receive a corresponding recess 3177). The modification would involve one protrusion on the opposite lateral side along with a corresponding recess to align to the protrusion (Hartono, see annotated Figure 61 below; the boxed area is where the placement of the male/female protrusion and recess is). The modification of adding one protrusion and recess on the opposite lateral side would make the added protrusion the second frame interlock portion and the added recess acts as the second cushion module interlock portion. Further, Hartono also includes the idea of the frame connection structure that can act as a cushion clip which includes the ability for the cushion assembly and frame assembly to maintain a connection that is not easily removeable but can be released and clipped together (Hartono, [0306] discloses the cushion assembly 3075 and frame assembly 3500 can be arranged to be removeable and repeatedly clipped together. It further discloses that in some cases the frame connection structure 3150 can act as a clip structure. Additionally, it would be obvious to add another recess and corresponding protrusion on the opposite side of the frame assembly and cushion assembly in order to achieve a better alignment and/or a better connection between the two components (See MPEP 2144.04 (VI)(B) – Duplication of Parts for more information). Performing this duplication would not be unexpected as the recess/protrusion coupling would not provide an unexpected result. Use of a mirrored protrusion and recess would allow for a better alignment and for better security between the connections of the frame assembly and cushion assembly. With the modifications, the ability to flex the frame (Hartono, [0291] discloses that the frame main body 3510 may be constructed by a relatively rigid material which could potentially still allow for bending; the claimed invention also points to the use of rigidiser arms in order to help the bending of the frame body; [0293] discloses that rigidiser arms 3302 are included and connected to the main body 3510 by flexible joints 3305 which may act in the same manner as the claimed invention. [0451] discloses that a structure with inherent stiffness can offer different resistances in different directions) to increase the distance between the first and second frame interlock portions as well as the first and second cushion interlock modules would be feasible with the introduction of the mirrored set of connections ([0454] discloses that an I-beam can have a different bending stiffness in a first direction versus a second direction meaning the component could be floppy in a first direction and rigid in a second; Fig 60, the rigidiser arms 3302 are placed on the each lateral side and are connected to flexible joints 3305; [0291] discloses that the frame main body 3510 is relatively rigid which infers difficulty to bend and could be configured to be flexible in one direction while maintaining stiffness in the opposite direction). Bending or flexing in different directions can increase the distances between the first and second frame interlock portions and the first and second cushion interlock directions and allow for release of the connected portions.
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Regarding claim 2, the modified patient interface of Hartono has the first cushion interlock portion comprises a first recess (Hartono, Fig 61, the first cushion interlock portion is on the left lateral side and is the recess 3177), the second cushion interlock portion comprises a second recess (Hartono, Fig 61, the second cushion interlock portion is on the right lateral side and is the recess 3177) , the first frame interlock portion comprises a first protrusion (Hartono, Fig 61, the first frame interlock portion is on the left lateral side and is the protrusion 3537), and the second frame interlock portion comprises a second protrusion (Hartono, Fig 61, the second frame interlock portion is on the right lateral side and is the protrusion 3537).
Regarding claim 3, the modified patient interface of Hartono has the patient-facing side of the frame body is concave (Hartono, Fig 61, the patient facing side is pointing toward the cushion assembly 3075 and you can see the concave curvature of the frame body 3510).
Regarding claim 4, the modified patient interface of Hartono has the first frame interlock portion and the second frame interlock portion extend outwardly from a patient-facing side of the frame in a substantially parallel direction to a frontal plane of the patient during use (Hartono, Fig 60, the protrusion 3537 is pointing outward toward the patient facing side of the frame main body 3510 and when in use, the mask is on the patient’s “frontal” place and the protrusion is parallel to the frontal plane of the patient).
Regarding claim 5, the modified patient interface of Hartono has the cushion module comprises a cushion and a cushion clip (Hartono, Fig 60, the cushion is best represented by 3100. The cushion clip is the frame connection portion 3150) wherein the first cushion module interlock portion and the second cushion module interlock portion are provided on the cushion clip (Hartono, Fig 59, the recesses 3177 on each lateral side, acting as the first cushion module interlock portion and the second cushion module interlock portion, are on the frame connection portion).
Regarding claim 6, the modified patient interface of Hartono has the cushion clip forms a loop around the plenum chamber inlet port (Hartono, Fig 59, the frame connection portion 3150 is in the shape of an oval which loops around the plenum chamber inlet port. Fig 58, the inner circle of the cover connecting portion 3540 is the plenum chamber inlet port).
Regarding claim 7, the modified patient interface of Hartono has the cushion module is connected to the frame, the cushion clip forms a loop around the frame opening (Hartono, Fig 59 and 60, the frame connection portion 3150 is connected with the walls on the outside of the cushion connecting portion 3530 which is implied when the protrusions 3537 are meant to connect in the recesses 3177 on the inner side of the frame connection portion).
Regarding claim 9, the modified patient interface of Hartono has the plenum chamber substantially defines a volume of space (Hartono, [0419] discloses that the patient interface 3000 has one or more ports that give access to the volume in the plenum chamber 3200) and the plenum chamber comprises an anterior wall substantially forming an anterior boundary of the volume of space during use (Hartono, Fig 58, the volume of space is in between the frame assembly 3500 and the cushion assembly 3075/seal-forming structure 3100 with the anterior wall being the frame main body 3510).
Regarding claim 10, the modified patient interface of Hartono has the plenum chamber and the frame together substantially define a volume of space and the frame forms an anterior boundary of the volume of space during use (Hartono, [0235] discloses that the frame assembly and the cushion assembly 3075 form a plenum chamber 3200 where the plenum chamber can receive a flow of air. Fig 58, the volume of space is created between the frame assembly 3500 and the cushion assembly 3075 where the frame main body 3510 acts as the anterior boundary).
Regarding claim 11, the modified patient interface of Hartono has the plenum chamber inlet port located in a central region of the plenum chamber (Hartono, Fig 58, the cover connecting portion 3540 is the plenum chamber inlet port and is in the center of the plenum chamber).
Regarding claim 13, the modified patient interface of Hartono has the frame opening is positioned substantially centrally in the frame body (Hartono, Fig 58, the frame assembly 3500 has a centrally positioned cover connecting portion 3540 which acts as the frame opening).
Regarding claim 15, the modified patient interface of Hartono has the frame body is configured to bend relatively easily when a force is applied to the lateral edges of the frame body (Hartono, [0291] discloses that the frame main body 3510 may be constructed by a relatively rigid material which could potentially still allow for bending; the claimed invention also points to the use of rigidiser arms in order to help the bending of the frame body; Hartono, [0293] discloses that rigidiser arms 3302 are included and connected to the main body 3510 by flexible joints 3305 which may act in the same manner as the claimed invention) in order to push the lateral edges of the frame body towards or away from the patient’s face in use and the frame body is configured to be difficult to bend when a force is applied to the superior and inferior edges of the frame body in order to push the superior and inferior edges of the frame body towards or away from the patient’s face in use (Hartono, [0454] discloses that an I-beam can have a different bending stiffness in a first direction versus a second direction meaning the component could be floppy in a first direction and rigid in a second; Hartono, Fig 60, the rigidiser arms 3302 are placed on the each lateral side and are connected to flexible joints 3305; [0291] discloses that the frame main body 3510 is relatively rigid which infers difficulty to bend and could be configured to be flexible in one direction while maintaining stiffness in the opposite direction).
Regarding claim 16, the modified patient interface of Hartono has the patient interface further comprises a rigidiser arm extending laterally outwardly from each distal end of the frame body (Hartono, Fig 60, the rigidiser arms 3302 are placed laterally on each side of the frame main body 3510 and are outward from the distal end of the frame main body).
Regarding claim 17, the modified patient interface of Hartono has the frame body comprises a collar surrounding the frame opening (Hartono, Fig 58, the frame opening is best represented by the cover connecting portion 3540 and the collar would be best represented by 3511).
Regarding claim 18, the modified patient interface of Hartono has the patient interface (Hartono, Fig 1A, the patient interface 3000) further comprises a vent configured to allow a continuous flow of gases exhaled by the patient from an interior of the plenum chamber to ambient, said vent being configured to maintain the therapeutic pressure in the plenum chamber in use (Hartono, [0373] discloses that the vent 3400 is configured to allow a continuous to vent flow from an interior of the plenum chamber 3200 to ambient whilst the pressure within the plenum chamber is positive with respect to ambient. It further discloses the vent helps maintain therapeutic pressure in the plenum chamber while preventing re-breathing of exhaled carbon dioxide. Hartono, [0091] discloses that the vent assembly has a main body and includes a plurality of orifices extending from the main body to allow gas to the plenum chamber. Hartono, [0292] discloses the main body 3510 includes a cover 3580 and maintains diffusing members of the vent within the frame assembly 3500; Hartono, Fig 60, the main body 3510 is shown with a series of holes that represents the vent 3400 where the main body is part of the frame assembly and the vent would live within the frame assembly).
Regarding claim 19, the modified patient interface of Hartono has the patient interface further comprises headgear for positioning and stabilizing the patient interface in a therapeutically effective position on the patient’s head in use (Hartono, [0080] discloses that the positioning and stabilizing structure is configured to hold the seal-forming structure in a therapeutically effective position to the patient’s head. [0342] discloses that the positioning and stabilizing structure 3300 is comprised of pair of rigidiser arms 3302 and a headgear assembly 3330 which help ensure the sealing position is maintained through the tension generated between the headgear and the seal-forming structure 3100).
Claim 8, 12, 14 is rejected under 35 U.S.C. 103 as being unpatentable over Hartono et al as applied to claim 1 above, and further in view of Law et al (US 2022/0296837 A1).
Regarding claim 8, the modified patient interface of Hartono has the cushion clip (Hartono, Fig 59, the cushion clip is the frame connection portion 3150) and the frame (Hartono, Fig 58, the frame assembly 3500).
The modified patient interface of Hartono does not have a cushion clip that is more rigid than the frame.
However, Law discloses a similar patient interface which has a cushion module that can be constructed of a polycarbonate (Law, [0412] discloses that the cushion module could be made of or partially made of transparent polycarbonate) which is described as a more rigid material (Law, [0909] discloses that a ‘hard’ material may be polycarbonate). Law further discloses the concept of “greater thickness” relating to a “greater stiffness” in different areas of the device (Law, [0701] discloses that a greater thickness of the posterior regions may be greater than the thickness of the central regions which cause the posterior regions to be stiffer as a result).
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 patient interface of Hartono to include the cushion module being constructed of polycarbonate and utilizing a greater thickness to achieve a greater stiffness concept as taught by Law. By modifying the cushion clip to use a stiffer or “harder” material while also including a greater thickness similarly to the claimed invention, then the cushion clip can have a “more rigid” structure compared to the frame. Further, it would be obvious to try different shapes, sizes, thicknesses, and materials in order to achieve a more rigid cushion clip structure in the modified patient interface of Hartono, as one would also expect the modified version to provide predictable solutions with a reasonable expectation of success (See MPEP 2143(I)(E) – “obvious to try” for more information). Use of a greater thickness and different materials can allow for a greater stiffness or more rigid structure of certain components compared to others.
Regarding claim 12, the modified patient interface of Hartono has a single and centrally placed plenum chamber inlet port (Hartono, Fig 58, the cover connecting portion 3540 is the plenum chamber inlet port) which is configured to receive the flow of breathable gas ( Hartono, [0080] discloses the patient interface 3000 is configured to allow the patient to breathe via a plenum chamber inlet port that is sized and structure to receive a flow of air).
The modified patient interface of Hartono does not have the plenum chamber inlet port is a first plenum chamber inlet port located on a first lateral side of the plenum chamber and the plenum chamber further forms a second plenum chamber inlet port located on a second lateral side of the plenum chamber, wherein the second plenum chamber inlet port is configured to receive the flow of breathable gas.
However, Law discloses a similar patient interface with a pair of laterally placed inlet holes which have a connecting portion to receive a flow of air into an interior of a cushion module (Law, [0420] discloses that a pair of laterally projection connection portions 3212 are comprised of a first and second inlets on both sides to receive a flow of air to the cushion module 3150). The first and second inlet holes also include a tube connection (Law, [0407] discloses that the lateral inlet holes 3212 are configured to connect to the gas delivery tubes 3350 that are sized and structured to receive a flow of air while also forming the plenum chamber 3200) that also includes a rigidiser that may be “substantially rigid” meaning finger pressure cannot deform the material alone, as well (Law, [0423] discloses that the rigidiser portion would have the ability to be substantially rigid and can be different materials and provided on each side of the cushion module). The tubes can also be a part of the positioning and stabilizing structure to air in positioning and stabilizing the seal-forming structure (Law, [0567] discloses that the positioning and stabilizing structure 3300 has tubes 3350 to position and stabilize the seal-forming structure 3100 to the patient’s airways). Law discloses a cushion module which is connected to a seal-forming structure which is connected to the cushion module (Law, Fig 7C, the cushion module 3150 is attached to the seal-forming structure 3100 and connected to the first and second inlet holes on each lateral side 3212).
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 patient interface of Hartono to include a first and second inlet holes on each lateral side as taught by Law. The modification would not have the centrally placed plenum chamber inlet hole as the first and second inlet holes, in some forms, replace the need for a singular hole. The placement of the first and second lateral inlet holes would be included on the frame body where the rigidiser arms could be connected to the flexible joints provided on each side overlaying the connection of the tubes to the inlet holes. The rigidiser arms would function to aid in flexing the frame to be able to release and re-clip the frame assembly and cushion assembly as needed. Further, tubes would be sized and structured to fluidly connect to the first and second inlet holes and the inlet holes can allow for a flow of breathable air where the first and second inlet holes form a plenum chamber. Use of the first and second plenum chamber inlet holes allow for receiving a flow of breathable gas and the tube connections aid in positioning and stabilizing the mask to the patient’s airways.
Regarding claim 14, the modified patient interface of Hartono has the frame body (Hartono, Fig 58, the frame assembly 3500) comprises an elongate hollow body with openings at each lateral end, wherein the openings are configured to receive the flow of breathable gas (Law, [0407] discloses that the lateral inlet holes 3212 are configured to connect to the gas delivery tubes 3350 that are sized and structured to receive a flow of air while also forming the plenum chamber 3200).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Hartono et al (US 2024/0148999 A1) and Short (WO 2022/073075 A1) are all patient interface systems that include a cushion, seal-forming structure, headgear, plenum chamber, inlet holes, and vents.
Chodkowski (US 2018/0264218 A1) and Chodkowski (US 2019/0091428 A1) are both patient interface systems with double inlet holes on each lateral side.
Amarasinghe et al (US 2018/0250486 A1), Goldspink (US 2025/0082885 A1) and Harrington (US 2016/0175552 A1) are patient interface systems that include locking tabs or clips or catch mechanisms for connection between a frame and a cushion.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAMIE H. BISHOP whose telephone number is (571)270-1093. The examiner can normally be reached Mon-Thurs: 7:15am-4:15pm; Friday: 7:15-3:15pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Timothy Stanis can be reached at (571) 272-5139. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/JAMIE H. BISHOP/Examiner, Art Unit 3785
/TIMOTHY A STANIS/Supervisory Patent Examiner, Art Unit 3785
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