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 .
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference character “40” has been used to designate both the intake air hose and the intake air hole(s). Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claims 1-3, 7-10, and 14-17 are objected to because of the following informalities:
Claim 1 (line 3), claim 8 (line 4), and claim 15 (line 4): “seals around one or both of a nose and a mouth of a user” should read “is configured to seal around one or both of a nose and a mouth of a user” to avoid an interpretation of the limitation encompassing, or being directed to, a human organism (e.g., nose and mouth of a user).
Claim 1 (line 6): The spacing between “contact” and “with” should be a single space.
Claim 2, claim 7, claim 9, claim 14, and claim 16: “the intake air hose” should read “the one or more intake air hoses” for clarity and consistency.
Claim 3, claim 10, and claim 17: “the user’s head, neck, and ear” should read “a head, a neck, and an ear of the user” to establish antecedent basis.
Claim 8, lines 2-3: “providing input air and exhaust gas from the user” should read “providing input air to the user and removing exhaust gas from the user” for clarity.
Appropriate correction is required.
Claim Rejections - 35 USC § 102
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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 3, 8, 10, 15, and 17 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Jestrabek-Hart (US 20010032648 A1).
Regarding claim 1, Jestrabek-Hart discloses a mask system (Figs. 1-2) for use in continuous positive airway pressure (CPAP) ([0010]) or bilevel positive airway pressure (BiPAP) therapy, the mask system comprising:
a mask (34; Figs. 1-2) comprising (i) a cup (see Annotated Fig. 2 below) that seals around one or both of a nose and a mouth of a user ([0010]), and (ii) head gear (see headgear in Figs. 1-2);
one or more intake air hoses (26; Figs. 1-2) designed to couple with a CPAP or BiPAP machine (see Fig. 7A, where 26 is coupled with air supply 35, where air is supplied by a CPAP device); and
one or more exhaust air hoses (30; Figs. 1-2) that are in physical contact with the one or more intake air hoses (30 in physical contact with 26, see Figs. 1-2; [0025]).
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Annotated Fig. 2
Regarding claim 3, Jestrabek-Hart discloses the invention as set forth in claim 1, wherein the head gear comprises a plurality of straps designed to loop around one or more of the user’s head, neck, and ear (see Figs. 1-2).
Regarding claim 8, Jestrabek-Hart discloses a method of using a continuous positive airway pressure (CPAP) or a bilevel positive airway pressure (BiPAP) machine comprising fitting a user with a mask system (Figs. 1-2 and 7B) and providing input air and exhaust gas from the user ([0010]-[0011]); wherein the mask system comprises:
a mask (34; Figs. 1-2) comprising (i) a cup (see Annotated Fig. 2 below) that seals around one or both of a nose and a mouth of a user ([0010]), and (ii) head gear (see headgear in Figs. 1-2);
one or more intake air hoses (26; Figs. 1-2) designed to couple with a CPAP or BiPAP machine (see Fig. 7A, where 26 is coupled with air supply 35, where air is supplied by a CPAP device); and
one or more exhaust air hoses (30; Figs. 1-2) that are in physical contact with the one or more intake air hoses (30 in physical contact with 26, see Figs. 1-2; [0025]).
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Annotated Fig. 2
Regarding claim 10, Jestrabek-Hart discloses the invention as set forth in claim 8, wherein the head gear comprises a plurality of straps designed to loop around one or more of the user’s head, neck, and ear (see Figs. 1-2).
Regarding claim 15, Jestrabek-Hart discloses a method of treating sleep apnea comprising use of a mask system (Figs. 1-2) in conjunction with a continuous positive airway pressure (CPAP) (35, where 35 is a CPAP device; [0010]) or a bilevel positive airway pressure (BiPAP) machine to provide positive air pressure to a user (Abstract; [0010]); the mask system comprising:
a mask (34; Figs. 1-2) comprising (i) a cup (see Annotated Fig. 2 below) that seals around one or both of a nose and a mouth of a user ([0010]), and (ii) head gear (see headgear in Figs. 1-2);
one or more intake air hoses (26; Figs. 1-2) designed to couple with a CPAP or BiPAP machine (see Fig. 7A, where 26 is coupled with air supply 35, where air is supplied by a CPAP device); and
one or more exhaust air hoses (30; Figs. 1-2) that are in physical contact with the one or more intake air hoses (30 in physical contact with 26, see Figs. 1-2; [0025]).
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Annotated Fig. 2
Regarding claim 17, Jestrabek-Hart discloses the invention as set forth in claim 15, wherein the head gear comprises a plurality of straps designed to loop around one or more of the user’s head, neck, and ear (see Figs. 1-2).
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.
Claims 2, 9, and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Jestrabek-Hart (US 20010032648 A1) in view of Lurie et al. (US 20100319691 A1), hereinafter Lurie.
Regarding claim 2, Jestrabek-Hart discloses the invention as set forth in claim 1. Jestrabek-Hart fails to explicitly disclose wherein the one or more exhaust air hoses surround the intake air hose.
However, Lurie teaches an analogous mask system with a dual limb patient circuit, where an inner lumen is an inspiratory path and an outer lumen is an expiratory path ([0189], lines 3-8).
Therefore, it would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the intake air hose (26) and exhaust air hose (30) taught by Jestrabek-Hart to be arranged concentrically, as taught by Lurie, such that the one or more exhaust air hoses surround the intake air hose (30 is arranged concentrically around 26 as taught by Lurie [0189], lines 3-8) to prevent mixing up the intake air hose and exhaust air hose connections to the mask and/or CPAP device, facilitating the setup and connection of the mask system and the CPAP device (Lurie [0189], lines 13-17).
Regarding claim 9, Jestrabek-Hart discloses the invention as set forth in claim 8. Jestrabek-Hart fails to explicitly disclose wherein the one or more exhaust air hoses surround the intake air hose.
However, Lurie teaches an analogous mask system with a dual limb patient circuit, where an inner lumen is an inspiratory path and an outer lumen is an expiratory path ([0189], lines 3-8).
Therefore, it would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the intake air hose (26) and exhaust air hose (30) taught by Jestrabek-Hart to be arranged concentrically, as taught by Lurie, such that the one or more exhaust air hoses surround the intake air hose (30 is arranged concentrically around 26 as taught by Lurie [0189], lines 3-8) to prevent mixing up the intake air hose and exhaust air hose connections to the mask and/or CPAP device, facilitating the setup and connection of the mask system and the CPAP device (Lurie [0189], lines 13-17).
Regarding claim 16, Jestrabek-Hart discloses the invention as set forth in claim 15. Jestrabek-Hart fails to explicitly disclose wherein the one or more exhaust air hoses surround the intake air hose.
However, Lurie teaches an analogous mask system with a dual limb patient circuit, where an inner lumen is an inspiratory path and an outer lumen is an expiratory path ([0189], lines 3-8).
Therefore, it would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the intake air hose (26) and exhaust air hose (30) taught by Jestrabek-Hart to be arranged concentrically, as taught by Lurie, such that the one or more exhaust air hoses surround the intake air hose (30 is arranged concentrically around 26 as taught by Lurie [0189], lines 3-8) to prevent mixing up the intake air hose and exhaust air hose connections to the mask and/or CPAP device, facilitating the setup and connection of the mask system and the CPAP device (Lurie [0189], lines 13-17).
Claims 4-7, 11-14, and 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Jestrabek-Hart (US 20010032648 A1) in view of Lalonde (US 20130104883 A1).
Regarding claim 4, Jestrabek-Hart discloses the invention as set forth in claim 1. The mask system disclosed by Jestrabek-Hart is silent to comprising a plurality of exhaust ports to pass exhaust to the one or more exhaust air hoses.
However, an analogous mask system (Fig. 2A) with a plurality of exhaust ports (106; Figs. 2A-2B) to pass exhaust to an exhaust air hose (144; [0056]).
Therefore, it would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the mask system taught by Jestrabek-Hart to have plurality of exhaust ports (Lalonde 106; Lalonde Figs. 2A-2B), as taught by Lalonde, such that the plurality of exhaust ports (Lalonde 106; Lalonde Figs. 2A-2B) pass exhaust to an exhaust air hose (pass exhaust to Jestrabek-Hart 30; Lalonde [0056]) to increase patient comfort by managing the pressure within the mask (Lalonde [0009]).
Regarding claim 5, Jestrabek-Hart as modified teaches the invention as set forth in claim 4, wherein the one or more exhaust air hoses are not coupled to the CPAP or BiPAP machine (30 is not coupled to 35, see Figs. 1-2 and 7B).
Regarding claim 6, Jestrabek-Hart as modified teaches the invention as set forth in claim 4. Jestrabek-Hart as modified fails to teach wherein the one or more exhaust air hoses are coupled to the CPAP or BiPAP machine.
However, Lalonde teaches an exhaust conduit (144; Fig. 2A) coupled to a CPAP device (144 couples to CPAP system 20, see Fig. 1, where hose 26 includes conduit 144; [0056]), where the CPAP device (20) includes a heat moisture exchanger (HME 210; Fig. 4) to collect moisture from a user’s exhalation to humidify a pressurized air flow provided to the user ([0059]).
Therefore, it would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to further modify the mask system taught by Jestrabek-Hart with Lalonde such that the one or more exhaust air hoses (30) are coupled to the CPAP (35; Lalonde [0056]) machine to improve patient comfort by reclaiming moisture from exhaled air to humidify the air being supplied to the user (Lalonde [0059]).
Regarding claim 7, Jestrabek-Hart as modified teaches the invention as set forth in claim 6, wherein moisture contained in the exhaust is recycled for use in humidifying air for use in the intake air hose (26; Lalonde [0059]).
Regarding claim 11, Jestrabek-Hart discloses the invention as set forth in claim 8. The mask system disclosed by Jestrabek-Hart is silent to comprising a plurality of exhaust ports to pass exhaust to the one or more exhaust air hoses.
However, an analogous mask system (Fig. 2A) with a plurality of exhaust ports (106; Figs. 2A-2B) to pass exhaust to an exhaust air hose (144; [0056]).
Therefore, it would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the mask system taught by Jestrabek-Hart to have plurality of exhaust ports (Lalonde 106; Lalonde Figs. 2A-2B), as taught by Lalonde, such that the plurality of exhaust ports (Lalonde 106; Lalonde Figs. 2A-2B) pass exhaust to an exhaust air hose (pass exhaust to Jestrabek-Hart 30; Lalonde [0056]) to increase patient comfort by managing the pressure within the mask (Lalonde [0009]).
Regarding claim 12, Jestrabek-Hart as modified teaches the invention as set forth in claim 11, wherein the one or more exhaust hoses are not coupled to the CPAP or BiPAP machine (30 is not coupled to 35, see Figs. 1-2 and 7B).
Regarding claim 13, Jestrabek-Hart as modified teaches the invention as set forth in claim 11. Jestrabek-Hart as modified fails to teach wherein the one or more exhaust air hoses are coupled to the CPAP or BiPAP machine.
However, Lalonde teaches an exhaust conduit (144; Fig. 2A) coupled to a CPAP device (144 couples to CPAP system 20, see Fig. 1, where hose 26 includes conduit 144; [0056]), where the CPAP device (20) includes a heat moisture exchanger (HME 210; Fig. 4) to collect moisture from a user’s exhalation to humidify a pressurized air flow provided to the user ([0059]).
Therefore, it would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to further modify the mask system taught by Jestrabek-Hart with Lalonde such that the one or more exhaust air hoses (30) are coupled to the CPAP (35; Lalonde [0056]) machine to improve patient comfort by reclaiming moisture from exhaled air to humidify the air being supplied to the user (Lalonde [0059]).
Regarding claim 14, Jestrabek-Hart as modified teaches the invention as set forth in claim 13, wherein moisture contained in the exhaust is recycled for use in humidifying air for use in the intake air hose (26; Lalonde [0059]).
Regarding claim 18, Jestrabek-Hart discloses the invention as set forth in claim 15. The mask system disclosed by Jestrabek-Hart is silent to comprising a plurality of exhaust ports to pass exhaust to the one or more exhaust air hoses.
However, an analogous mask system (Fig. 2A) with a plurality of exhaust ports (106; Figs. 2A-2B) to pass exhaust to an exhaust air hose (144; [0056]).
Therefore, it would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the mask system taught by Jestrabek-Hart to have plurality of exhaust ports (Lalonde 106; Lalonde Figs. 2A-2B), as taught by Lalonde, such that the plurality of exhaust ports (Lalonde 106; Lalonde Figs. 2A-2B) pass exhaust to an exhaust air hose (pass exhaust to Jestrabek-Hart 30; Lalonde [0056]) to increase patient comfort by managing the pressure within the mask (Lalonde [0009]).
Regarding claim 19, Jestrabek-Hart as modified teaches the invention as set forth in claim 18, wherein the one or more exhaust air hoses are not coupled to the CPAP or BiPAP machine (30 is not coupled to 35, see Figs. 1-2 and 7B).
Regarding claim 20, Jestrabek-Hart discloses the invention as set forth in claim 17. Jestrabek-Hart as modified fails to teach wherein the one or more exhaust air hoses are coupled to the CPAP or BiPAP machine.
However, Lalonde teaches an exhaust conduit (144; Fig. 2A) coupled to a CPAP device (144 couples to CPAP system 20, see Fig. 1, where hose 26 includes conduit 144; [0056]), where the CPAP device (20) includes a heat moisture exchanger (HME 210; Fig. 4) to collect moisture from a user’s exhalation to humidify a pressurized air flow provided to the user ([0059]).
Therefore, it would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to further modify the mask system taught by Jestrabek-Hart with Lalonde such that the one or more exhaust air hoses (30) are coupled to the CPAP (35; Lalonde [0056]) machine to improve patient comfort by reclaiming moisture from exhaled air to humidify the air being supplied to the user (Lalonde [0059]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Burk (US 20060157056 A1): Regarding a heat and moisture exchanging device for respiratory therapy with an inspiratory circuit tube and an expiratory circuit tube in physical contact with one another.
Hurmez et al. (US 20130098360 A1): Regarding a respiratory therapy system with a inspiratory tube and an expiratory tube in physical contact with one another at an outlet, and further includes recycling humidity from expiratory gases to humidify the air supplied to a user.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ABIGAYLE DALE whose telephone number is (571)272-1080. The examiner can normally be reached Monday-Friday from 8:45am to 5:45pm ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Brandy Lee can be reached at (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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/ABIGAYLE DALE/Examiner, Art Unit 3785
/BRANDY S LEE/Supervisory Patent Examiner, Art Unit 3785