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 .
Claim Objections
Claim 1 is objected to because of the following informalities:
Line 12 of claim 1 should read --the vent structure--, as the vent structure has already been introduced in the preceding line.
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.
Claim(s) 1-5, 8-17 and 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Nelson et al. (US 2020/0324150 A1) in view of Dantanarayana et al. (US2004/0094157 A1).
Regarding claim 1, Nelson teaches a patient interface comprising a plenum chamber and a seal-forming structure (patient interface 400 comprising a mask body 3 forming a chamber and a mask seal 4, Abstract, Paragraph 0180 and Figures 20-23), the patient interface also comprising a positioning and stabilising structure to provide a force to hold the seal-forming structure in a therapeutically effective position on a patient’s head (the mask is held in place on a user by a headgear assembly 7 that extends around a part or parts of a user’s head, Paragraph 0140 and Figure 1; see also Paragraph 0197 stating features from differing embodiments may be combined), wherein the seal-forming structure is 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 cmH2O above ambient air pressure throughout the patient’s respiratory cycle in use (mask seal 4 configured to cover the user’s mouth and/or nose to deliver the respiratory gases to the user from the gas source, the pressurized gas source is fully capable of delivering a flow of air at a therapeutic pressure of at least 6 cm H2O above ambient, Paragraphs 0139, 0005), the plenum chamber comprising: a chassis having an anterior surface and a posterior surface (mask body 3 comprises an anterior surface and posterior surface, Figure 21 and Paragraph 0058), wherein the posterior surface defines at least a portion of the plenum chamber (the mask body 3 and mask seal 4 are arranged to define an interior breathing chamber of the patient interface, therefore the posterior surface of the mask body 3 defines at least a portion of the chamber, Paragraph 0058 and Figure 15); an opening extending between the anterior surface and the posterior surface (see vent opening 409 extending between the anterior and posterior surface of the mask body 3, Paragraph 0181 and Figures 20-21), the opening configured to receive a vent structure (opening 409 configured to receive a valve flap 405, Paragraphs 0181-0185 and Figures 20-21); wherein the vent structure is configured to engage with the opening such that the vent surface is pivotally moveable relative to the anterior surface of the plenum chamber (the valve flap 405 is pivotally mounted to the interior side of the mask body above the valve opening 409 via a mount 411, Paragraph 0181 and Figures 20-21).
Although Nelson teaches a pivotally mounted vent structure, Nelson is silent on the vent structure including a vent surface provided with one or more holes.
However, Dantanarayana teaches a patient interface device (mask 32, Figures 7-8, abstract) comprising a pivoting venting assembly (flow regulation vent 10 comprising a pivotable portion 12, a base portion 30, and cover 40 Paragraph 0070 and Figures 1-4) wherein the venting surface is provided with one or more holes (the cover 40 and base 30 may comprise one or more orifices 38 and 42, Paragraph 0071 and Figure 4).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify Nelson’s patient interface device by having the valve flap surface comprise one or more vent holes, as taught by Dantanarayana, as providing a plurality of smaller venting holes may help in reducing venting airflow noises within the device while it is being worn by the user (Paragraph 0071 of Dantanarayana).
Regarding claim 2, Nelson teaches a plenum chamber for a patient interface, the plenum chamber (patient interface 400 comprising a mask body 3 forming a chamber and a mask seal 4, Abstract, Paragraph 0180 and Figures 20-23) comprising: a chassis having an anterior surface and a posterior surface (mask body 3 comprises an anterior surface and posterior surface, Figure 21 and Paragraph 0058), wherein the posterior surface defines at least a portion of the plenum chamber (the mask body 3 and mask seal 4 are arranged to define an interior breathing chamber of the patient interface, therefore the posterior surface of the mask body 3 defines at least a portion of the chamber, Paragraph 0058 and Figure 15); an opening extending between the anterior surface and the posterior surface (see vent opening 409 extending between the anterior and posterior surface of the mask body 3, Paragraph 0181 and Figures 20-21), the opening configured to receive a vent structure (opening 409 configured to receive a valve flap 405, Paragraphs 0181-0185 and Figures 20-21); and wherein the vent structure is configured to engage with the opening such that the vent surface is pivotally moveable relative to the anterior surface of the plenum chamber (the valve flap 405 is pivotally mounted to the interior side of the mask body above the valve opening 409 via a mount 411, Paragraph 0181 and Figures 20-21).
Again, although Nelson teaches a pivotally mounted vent structure, Nelson is silent on the vent structure including a vent surface provided with one or more holes.
However, Dantanarayana teaches a patient interface device (mask 32, Figures 7-8, abstract) comprising a pivoting venting assembly (flow regulation vent 10 comprising a pivotable portion 12, a base portion 30, and cover 40 Paragraph 0070 and Figures 1-4) wherein the venting surface is provided with one or more holes (the cover 40 and base 30 may comprise one or more orifices 38 and 42, Paragraph 0071 and Figure 4).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify Nelson’s patient interface device by having the valve flap surface comprise one or more vent holes, as taught by Dantanarayana, as providing a plurality of smaller venting holes may help in reducing venting airflow noises within the device while it is being worn by the user (Paragraph 0071 of Dantanarayana).
Regarding claim 3, Nelson in view of Dantanarayana teach the plenum chamber as claimed in claim 2, with Nelson further teaching wherein the opening of the plenum chamber includes at least one flange extending posteriorly into the plenum chamber (opening 409 includes a peripheral lip or flange that seals against the interior surface of the mask body 3, Paragraph 0181).
Regarding claim 4, Nelson further teaches wherein the flange substantially circumscribes the opening of the plenum chamber (opening 409 includes a peripheral lip or flange that seals against the interior surface of the mask body 3, Paragraph 0181).
Regarding claim 5, Nelson in view of Dantanarayana teach the plenum chamber as claimed in claim 2, with Nelson further teaching wherein the vent structure includes a body (valve 403 comprises a valve flap 405 body, Paragraph 0180 and Figures 20-21).
Regarding claim 8, Nelson further teaches wherein the vent structure includes an engagement portion configured to engage with a complementary engagement portion provided to a portion of the flange of the opening of the plenum chamber (The flap 405 comprises a body that fills opening 409 and a peripheral lip or flange that overlays and seals against the interior surface of the mask body 3 about the margin of the opening 409, an upper part of the flap 405 is pivotally mounted on the mask body 3 above the valve opening 409 via a mount 411, Paragraph 0181).
Regarding claim 9, Nelson in view of Dantanarayana teach the plenum chamber as claimed in claim 8, however is silent wherein the complementary engagement portion provided to the flange is the pin of a hinging mechanism.
However, Dantanarayana teaches a patient interface device (mask 32, Figures 7-8, abstract) comprising a pivoting venting structure (vent 10 comprising a pivotable portion 12, Paragraph 0070 and Figures 1-3) wherein the venting structure comprising an engaging portion in the form of a pin of hinging mechanism (a pin 62 is mounted to the cover 40 and contacts an edge of the movable portion 12, the pin 62 is a part of the hinge 16, Figure 11 and Paragraph 0082).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify Nelson’s patient interface by having the valve flap mounting element comprising a pin and a hinging mechanism, as taught by Dantanarayana, as providing a pin and hinge configuration is a well-known means of providing pivotable motion between two structural components.
Regarding claim 10, Dantanarayana further teaches wherein the engagement portion of the vent structure is a notch which receives the pin of the hinging mechanism (see notch 66 configured to receive the pin 62 of the hinging mechanism, Paragraph 0082 and Figure 11).
Regarding claim 11, Nelson further teaches wherein the opening of the plenum chamber is substantially rectangular in a plan view (see opening 409 being substantially rectangular, Figure 21).
Regarding claim 12, Nelson further teaches wherein at least a portion of the vent structure is substantially rectangular and complementary, in a plan view, to the opening of the plenum chamber (see vent flap 405 being substantially rectangular and complementary to the shape of the opening 409, Figure 21).
Regarding claim 13, Nelson further teaches wherein the vent structure is pivotal between an inferior orientation to a superior orientation (valve flap 405 is pivotally mounted to the interior side of the mask body 3, therefore pivotable between an inferior and superior orientation, Paragraph 0181).
Regarding claim 14, Nelson in view of Dantanarayana teach the plenum chamber as claimed in claim 2, with Nelson teaching an alternative embodiment wherein a portion of the vent structure is configured with a channel with a plurality of discrete notches (see embodiment shown in Figures 9-12 showing a vent structure configured with a channel have a plurality of discrete notches 209, Paragraph 0152; see also Paragraph 0197 stating features from differing embodiments may be combined).
Regarding claim 15, Nelson further teaches an alternative embodiment wherein a portion of the plenum chamber includes a structure configured to engage with the channel and the plurality of discrete notches in an interference fit (see embodiment shown in Figures 9-12 showing a vent structure configured with a channel have a plurality of discrete notches 209 configured to engage with the chamber, Paragraph 0152; see also Paragraph 0197 stating features from differing embodiments may be combined).
Regarding claim 16, Nelson in view of Dantanarayana teach the plenum chamber as claimed in claim 2, however is silent wherein the opening of the plenum chamber is substantially circular in a plan view.
However, Dantanarayana teaches a patient interface device (mask 32, Figures 7-8, abstract) comprising a pivoting venting structure (vent 10 comprising a pivotable portion 12, Paragraph 0070 and Figures 1-3) disposed in an opening of the chamber that is substantially circular in plain view (see vent 10 and corresponding opening being circular, Figure 1, 4).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify Nelson’s patient interface by having the opening of the chamber being substantially circular, as taught by Dantanarayana, or any other shape or expedient for a given application, as a change in shape is generally recognized as being within the level of ordinary skill in the art.
Regarding claim 17, Dantanarayana further teaches a portion of the vent structure is substantially spherical and complementary, in a plan view, to the opening of the plenum chamber (see circular vent 10 arrangement, Figure 1, 4).
Regarding claim 19, Nelson further teaches wherein the vent structure is pivotal between an inferior orientation to a superior orientation and at least one lateral orientation (valve flap 405 is pivotally mounted to the interior side of the mask body 3, or the flap 405 may be pivotably mounted at any other location, therefore fully capable of being pivotable between an inferior and superior orientation, or a lateral orientation, Paragraph 0181).
Regarding claim 20, Nelson further teaches wherein at least a portion of the vent structure is configured to receive a weight (a user may press the protrusion 425 of the flap 405, therefore configured to receive a weight of the user’s finger, Paragraph 0182).
Claims 6-7 are rejected under 35 U.S.C. 103 as being unpatentable over Nelson et al. (US 2020/0324150 A1) in view of Dantanarayana et al. (US 2004/0094157 A1) and in further view of Dantanarayana et al. (US 2022/0401681 A1).
Regarding claim 6, Nelson in view of Dantanarayana (‘157) teaches the plenum chamber as claimed in claim 5, however is silent wherein the body of the vent structure is received in the opening of the plenum chamber and engages with the flange in a friction fit.
However, Dantanarayana (‘681) teaches a patient interface device (Abstract, Figure 1) comprising a vent structure (vent module 3450, Figure 7B and Paragraph 0317) configured to be received in an opening of the chamber and engage with a flange via a friction-fit (vent module 3450 received in opening 3620 comprising a peripheral flange via a friction fit, Paragraph 0317 and Figure 7B).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify Nelson’s patient interface by having the vent structure friction-fit with the opening, as taught by Dantanarayana (‘681), as providing such a friction-fit connection may aid in the securement of the valve body within the opening.
Regarding claim 7, Nelson in view of Dantanarayana (‘157) teach the plenum chamber as claimed in claim 5, however is silent wherein the body of the vent structure is received in the opening of the plenum chamber and engages with the flange in a snap-lock fit.
However, Dantanarayana (‘681) teaches a patient interface device (Abstract, Figure 1) comprising a vent structure (vent module 3450, Figure 7B and Paragraph 0317) configured to be received in an opening of the chamber and engage with a flange via a snap-fit lock (vent module 3450 received in opening 3620 comprising a peripheral flange via a snap-fit mechanism, Paragraph 0317 and Figure 7B).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify Nelson’s patient interface by having the vent structure snap-fit with the opening, as taught by Dantanarayana, as providing such a snap-fit connection may aid in the securement of the valve body within the opening.
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Nelson et al. (US 2020/0324150 A1) in view of Dantanarayana et al. (US 2004/0094157 A1) and in further view of Fong et al. (US 2014/0150798 A1).
Regarding claim 18, Nelson in view of Dantanarayana teach the plenum chamber as claimed in claim 2, however is silent wherein the vent structure is received in the opening of the plenum chamber in a ball-joint fit.
However, Fong teaches a patient interface device (Abstract, Figure 1) comprising a vent structure (plurality of vents 145 on angled flange 141, Paragraph 0112 and Figure 32) wherein the vent structure is received in the opening of the chamber via a ball-joint fit (flange 141 comprising vents 145 disposed within opening of chamber 133 via a ball joint connection 140, Figure 32 and Paragraph 0116).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify Nelson’s patient interface by having the vent structure be received in the opening via a ball-joint fit, as such a connection allows for easy and quick movement or translation of the vent structure as needed.
Claims 21-24 are rejected under 35 U.S.C. 103 as being unpatentable over Nelson et al. (US 2020/0324150 A1) in view of Dantanarayana et al. (US 2004/0094157 A1) and in further view of Dantanarayana et al. (US 2022/0168521 A1).
Regarding claim 21, Nelson in view of Dantanarayana (‘157) teach the plenum chamber as claimed in claim 2, however is silent wherein at least a portion of the vent surface is provided with a magnet.
However, Dantanarayana (‘521) teaches a patient interface device (Abstract, Figure 1) comprising a vent structure (vent assembly 5400, Paragraph 0294 and Figures 7A-7C) wherein at least a portion of the vent structure is provided with a magnet (vent assembly 5400 may comprise an electro-magnetic activator 6900 structured and arranged to deflect the membrane 5800, therefore the vent surface has a magnet, Paragraph 0294 and Figures 7A-7C).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify Nelson’s patient interface by providing the vent structure with a magnet, as taught by Dantanarayana, as providing such a magnetic component to the venting structure may allow for precise control of the flow characteristics across the venting surface (Paragraph 0295 of Dantanarayana).
Regarding claim 22, Dantanarayana (‘521) further teaches wherein at least one structure comprising or including a magnetic material is provided adjacent the opening of the plenum chamber (vent assembly 5400 may comprise an electro-magnetic activator 6900 structured and arranged to deflect the membrane 5800, therefore the vent surface has a magnet, Paragraph 0294 and Figures 7A-7C).
Regarding claim 23, Dantanarayana (‘521) further teaches wherein the magnet of the vent surface is attracted to the magnetic material of the structure (vent assembly 5400 may comprise an electro-magnetic activator 6900 structured and arranged to deflect the membrane 5800, therefore fully capable of attracting the magnet in the membrane to corresponding magnet, Paragraph 0294 and Figures 7A-7C).
Regarding claim 24, Dantanarayana (‘521) further teaches wherein the magnet of the vent surface is repelled by the magnetic material of the structure (vent assembly 5400 may comprise an electro-magnetic activator 6900 structured and arranged to deflect the membrane 5800, therefore fully capable of repelling the magnet in the membrane to corresponding magnet, Paragraph 0294 and Figures 7A-7C).
Claims 21-24 are rejected under 35 U.S.C. 103 as being unpatentable over Nelson et al. (US 2020/0324150 A1) in view of Dantanarayana et al. (US 2004/0094157 A1) and in further view of Rummery et al. (US 2013/0152918 A1).
Regarding claim 25, Nelson in view of Dantanarayana teach the plenum chamber as claimed in claim 2, however is silent wherein the vent structure is comprised of one or more plastics material of polycarbonate (PCB), polypropylene (PPE), nylon or a blend thereof.
However, Rummery teaches a patient interface device (Abstract, Figure 1) comprising a vent structure comprised of polycarbonate (the vent may be constructed of a rigid or semi rigid material such as polycarbonate, Figure 4 and Paragraph 0102).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify Nelson’s patient interface by having the vent structure comprise a plastic such as polycarbonate, as it may offer various benefits such as high impact resistance, and lightweight durability.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: Huddart et al. (US 2016/0008558 A1) and Rose (US 2022/0023569 A1).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARAH B LEDERER whose telephone number is 571-272-7274. The examiner can normally be reached on Monday - Friday, 7:30 AM - 4:30 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Brandy Lee can be reached on (571)-270-7410. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SARAH B LEDERER/ Examiner, Art Unit 3785
/MARGARET M LUARCA/ Primary Examiner, Art Unit 3785
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