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 Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 41-42, 45-55, and 63-70 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kenyon (WO 2020/208603 A1).
Regarding claim 41, Kenyon discloses a patient interface for treating a patient with a respiratory disorder (Abstract, Paragraph 0163 and Figures 6A-6E), comprising: a respiratory pressure therapy (RPT) device (respiratory therapy device 3000, Figures 6A-6E) including an electric blower configured to generate pressurized breathable air (blower 4142 configured to provide a flow of pressurized breathable gas to the user, Paragraph 0193 and Figures 6A-6E); a seal-forming structure configured to form a seal against the patient's face (seal forming structure 3100, Paragraph 0193 and Figures 6A-6E), the seal-forming structure at least partially defining a plenum chamber configured to receive the pressurized air (plenum chamber 3200 configured to receive pressurized air, Paragraph 0193 and Figure 6B); a flow generator casing that at least partly encloses the electric blower and is connected to the plenum chamber (see flow generator housing 4132 enclosing the blower 4142 and connected to plenum chamber 3200, Figures 6A-6E and Paragraph 0213), the casing including at least one air opening to receive ambient air for delivery to the RPT device (opening 4143, Figures 20A and Paragraph 0209; see also openings 4306, Paragraph 0230 and Figure 22A); and a positioning and stabilising structure configured to maintain the seal-forming structure and the blower in a therapeutically effective position (headgear 3303 configured to maintain position of seal forming structure 3100 and blower 4142, Paragraph 0193 and Figures 6A-6E).
Regarding claim 42, Kenyon further discloses wherein the patient interface includes no tube or forehead support that is configured to extend between the patient's eyes (see Figure 6A showing no tube or forehead support extending between eyes of patient).
Regarding claim 45, Kenyon further discloses wherein the casing includes a rear case and a front case (see housing 4133 having both a front a rear portion, Figure 6D) that define a cavity in which the blower is fully enclosed (see Figure 6E showing a cavity formed within the housing 4133 such that the blower 4142 is enclosed).
Regarding claim 46, Kenyon further discloses wherein the casing includes a central section and two side sections (as housing 4133 is rectangular in shape, it comprises a central section and two side sections, Figure 6D), the central portion housing the blower (central section houses the blower 4142, Figure 6D), the central section and the side sections providing a continuous curvature (see sections of the housing 4133 forming a continuous curvature, Figure 6D).
Regarding claim 47, Kenyon further discloses wherein the front case is removably attached to the rear case to expose the blower within the cavity (housing portions may be removable to exposed blower 4142 within cavity, Figure 6E) and one or more electrical components within the cavity (motor 4145 disposed within housing cavity, Figure 6E).
Regarding claim 48, Kenyon further discloses wherein the one or more electrical components includes a pressure sensor (pressure sensor 4272, Paragraph 0277).
Regarding claim 49, Kenyon further discloses wherein the blower has a substantially cylindrical shape and is arranged laterally within the cavity anterior to the rear case (see Figure 6E showing cylindrical blower 4142 arranged laterally with cavity of housing).
Regarding claim 50, Kenyon further discloses wherein a longitudinal axis of the blower runs perpendicular to an inlet of the casing that leads to the plenum chamber (longitudinal axis of blower 4142 runs perpendicular to the inlet of the casing that leads to chamber 3200, Figures 6C, 20H).
Regarding claim 51, Kenyon further discloses further comprising a suspension to support the blower within the cavity (see blower 4142 suspended within cavity of housing via mounting rails 4183, Figure 6C and Paragraph 0291).
Regarding claim 52, Kenyon further discloses wherein the suspension includes at least a first opening to allow flow of ambient air into the blower, and a second opening to receive the air after pressurization (mounting rails 4183 form first a second openings, Figure 6C).
Regarding claim 53, Kenyon further discloses further comprising a manifold within the cavity and configured to guide the pressurized air from the blower towards the plenum chamber (a blower outlet 4141 is positioned downstream the second stator, such that a flow path 4138 is formed to guide air from blower 4142 towards chamber 3200, Paragraph 0290 and Figure 6E).
Regarding claim 54, Kenyon further discloses wherein the manifold redirects the pressurized air from one direction to another direction (see Figure 7E showing flow path 4138 within the cavity, such that the blower outlets 4141 redirect axially orientated air to another direction).
Regarding claim 55, Kenyon further discloses wherein the suspension includes an opening configured to direct pressurized air generated by the blower to a manifold configured to guide the pressurized air from the blower towards the plenum chamber (see Figure 7E showing flow path within the cavity, such that the mounting rails direct air from the blower towards the blower outlets 4141).
Regarding claim 63, Kenyon further discloses further comprising at least one gas washout vent configured to allow exhaled gas to exhaust to ambient, wherein the gas washout vent is provided as part of the front case and/or rear case and/or on the seal-forming portion (see vent washout assembly 3400 disposed on the casing, Figure 16A and Paragraph 0198).
Regarding claim 64, Kenyon further discloses wherein the blower includes at least a pair of impellers coupled to a common shaft and arranged in parallel (blower includes pair of impellers 4160 coupled to a common shaft 4146 arranged in parallel, Figure 14).
Regarding claim 65, Kenyon further discloses further comprising an elastomeric bearing configured to limit vibrations of the blower (the first impeller may comprise a deformable elastomeric materials such as silicone that may be coupled with second impeller, Paragraph 0353).
Regarding claim 66, Kenyon further discloses wherein the seal-forming portion includes a pillows mask, a full face mask or a nasal mask (seal forming structure 3100 is a nasal mask, Figure 6A).
Regarding claim 67, Kenyon further discloses wherein the seal-forming portion includes a first portion to surround the patient's mouth and a second portion to seal with a lower surface of the patient's nose (see Paragraph 0212 describing the seal forming structure 3100 may be formed as a oro-nasal cushion that includes separate openings to provide flow of gases to patient’s nose and mouth separately).
Regarding claim 68, Kenyon further discloses wherein the second portion includes a pair of openings to align with the patient's nares (see Paragraph 0212 describing the seal forming structure 3100 may be formed as a oro-nasal cushion that includes separate openings to provide flow of gases to patient’s nose and mouth separately).
Regarding claim 69, Kenyon further discloses wherein the seal-forming portion does not extend over the patient's nasal ridge (seal forming structure 3100 in the form of a pair of nasal inserts, therefore does not directly extend over nasal ridge, Figure 15b; see also Paragraph 0212).
Regarding claim 70, Kenyon further discloses further comprising 1) an electrical connector for connection to a power cord to power the blower with a power source, and/or 2) a battery to supply power to the blower (blower 4142 powered by a battery, Paragraph 0237).
Claim Rejections - 35 USC § 103
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 43 is rejected under 35 U.S.C. 103 as being unpatentable over Kenyon (WO 2020/208603 A1) in view of Taylor et al. (US 2013/0263854 A1).
Regarding claim 43, Kenyon teaches the patient interface of claim 41, however is silent wherein further comprising a display supported by the flow generator casing, the display being configured to generate a computer-generated image to the patient.
However, Taylor teaches a respiratory treatment apparatus (Abstract and Figure 1) comprising a flow generator casing (blower 124 is housed within chassis 21, Paragraph 0053 and Figure 1) wherein the casing further comprises a display configured to generate computer generated images (chassis 21 comprises a display device 24 which may control the generation of images, Paragraph 0069 and Figure 1).
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 Kenyon’s patient interface device by including a display device supported by the flow generator casing, as taught by Taylor, as providing a display device on the flow generator casing may allow useful apparatus information to be displayed to the user while the device is being used.
Claim(s) 56 is rejected under 35 U.S.C. 103 as being unpatentable over Kenyon (WO 2020/208603 A1) in view of Kuriger (WO 2017068530 A2).
Regarding claim 56, Kenyon teaches the patient interface of claim 41, and although Kenyon further teaches the plenum chamber including an anterior surface that receives an exterior part of the casing that houses the blower (Figures 6A-6E), Kenyon doesn’t explicitly state wherein the plenum chamber includes an anterior surface with a concave section that receives a convex exterior part of the casing or rear case that houses the blower.
However, Kuriger teaches a patient interface device (Abstract) comprising a plenum chamber having a concave section (see plenum chamber 550 having concave section, Figure 14B) configured to receive a corresponding convex exterior part of a casing configured to house a blower (see housing 533 configured to house blower 350, Figure 14b).
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 Kenyon’s patient interface device such that the plenum chamber and casing housing the blower comprise concave/convex portions, as taught by Kuriger, as providing concave surfaces intended to rest upon the user’s face may provide a more comfortable and secure fit.
Claim(s) 58-62 are rejected under 35 U.S.C. 103 as being unpatentable over Kenyon (WO 2020/208603 A1) in view of Yu et al. (US 2017/0361133 A1).
Regarding claim 58, Kenyon teaches the patient interface of claim 41, and although Kenyon further teaches a flexible membrane configured to open upon patient exhalation to thereby allow for exhaled gases to exit through vent holes to therefore direct pressurized gas from the chamber to an exhaust channel of the casing (membrane 3405 and vent holes 3402, Figure 21G Paragraph 0258), Kenyon is silent on an expiratory activated valve (EAV) to direct pressurized gas from the cavity to the plenum chamber during inhalation and/or from the plenum chamber to an exhaust channel of the casing during exhalation.
However, Yu teaches a respiratory apparatus configured to deliver pressurized gas to a user (Abstract) that may be configured as a respiratory mask (mask 2805, Paragraph 0202) wherein the mask further comprises an expiratory activated valve to direct pressurized gas to an exhaust channel upon exhalation (an expiratory activated valve (EAV) may be used to reduce the amount of CO2 built up at the mask interface, and may be triggered upon the detection of exhaling, Paragraph 0156)).
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 Kenyon’s patient interface device by including an expiratory activated valve (EAV), as taught by Yu, as providing such a valve would aid in the removal of built-up CO2 at the mask interface, reducing stuffiness felt by the user and therefore improving overall comfort (Paragraph 0156 of Yu).
Regarding claim 59, Kenyon in view of Yu teach the patient interface of claim 58, with Kenyon further teaching a one-way duck bill valve to direct incoming pressurized gas to the plenum chamber, the duck bill valve being movable between a closed position during exhalation and an open position during inhalation (see flexible membrane 3405 formed as a duck-bill valve that is moveable between and open and closed position, allowing exhaled gases to exit the vent holes upon exhalation, Figure 21G Paragraph 0258).
Again, Kenyon is silent on an expiratory activated valve (EAV).
However, Yu teaches a respiratory apparatus configured to deliver pressurized gas to a user (Abstract) that may be configured as a respiratory mask (mask 2805, Paragraph 0202) wherein the mask further comprises an expiratory activated valve to direct pressurized gas to an exhaust channel upon exhalation (an expiratory activated valve (EAV) may be used to reduce the amount of CO2 built up at the mask interface, and may be triggered upon the detection of exhaling, Paragraph 0156)).
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 Kenyon’s patient interface device by including an expiratory activated valve (EAV), as taught by Yu, as providing such a valve would aid in the removal of built-up CO2 at the mask interface, reducing stuffiness felt by the user and therefore improving overall comfort (Paragraph 0156 of Yu).
Regarding claim 60, Kenyon further teaches a membrane that is movable during exhalation while the duck bill valve is in the closed position to guide exhaled air along outside of the duck bill valve, such that in use the exhaled air passes through an exhaust channel (see flexible membrane 3405 formed as a duck-bill valve that is moveable between and open and closed position, allowing exhaled gases to exit the vent holes upon exhalation, Figure 21G Paragraph 0258).
Again, Kenyon is silent on an expiratory activated valve (EAV).
However, Yu teaches a respiratory apparatus configured to deliver pressurized gas to a user (Abstract) that may be configured as a respiratory mask (mask 2805, Paragraph 0202) wherein the mask further comprises an expiratory activated valve to direct pressurized gas to an exhaust channel upon exhalation (an expiratory activated valve (EAV) may be used to reduce the amount of CO2 built up at the mask interface, and may be triggered upon the detection of exhaling, Paragraph 0156)).
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 Kenyon’s patient interface device by including an expiratory activated valve (EAV), as taught by Yu, as providing such a valve would aid in the removal of built-up CO2 at the mask interface, reducing stuffiness felt by the user and therefore improving overall comfort (Paragraph 0156 of Yu).
Regarding claim 61, Kenyon further teaches wherein the exhaust channel directs exhaled gas to a gas washout vent having one or more holes leading to ambient (gas may be exhausted to ambient via vent holes 3402, Paragraph 0267).
Regarding claim 62, Kenyon further teaches wherein the duck bill valve is positioned within an inlet of the casing leading to the plenum chamber (membrane 3405 positioned at the inlet of the casing 4133 leading to the plenum chamber, Figure 21G).
Allowable Subject Matter
Claims 44, 57 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Regarding claim 44, although Taylor teaches a display disposed on a flow generator casing, neither Kenyon or Taylor teach wherein the flow generator casing has a single posterior opening dimensioned to span both the patient's eyes and allow the patient to view the display through the posterior opening, and further comprising a user interface structure corresponding to the posterior opening and being constructed of a comfortable material to engage the patient's forehead and extend around the patient's eyes.
Regarding claim 57, although Kenyon teaches a flow generator casing and a plenum chamber (Figure 6A), Kenyon is silent wherein the casing or rear case includes an inlet tube positioned above the convex exterior part of the casing or rear case and the plenum chamber includes an inlet opening removably attached to the inlet tube and positioned above the concave portion of the plenum chamber.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: Nitta et al. (US 2015/0217073 A1) and Ewers et al. (US 9,492,086 B2).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARAH B LEDERER whose telephone number is 571-272-7274. The examiner can normally be reached on Monday - Friday, 7:30 AM - 4:30 PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Brandy Lee can be reached on (571)-270-7410. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SARAH B LEDERER/Examiner, Art Unit 3785
/MARGARET M LUARCA/Primary Examiner, Art Unit 3785
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