DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
This Office Action is in response to the amendment filed on 04/15/2026. Claims 1, 3, 7-8, 10, 14-15, and 17 are amended. Claims 2, 9, and 16 are canceled. Claims 4-6, 10-13, and 18-20 are as previously presented. As such, claims 1, 3-8, 10-15, and 17-20 are pending in the instant application.
All objections have been withdrawn in light of the filed amendments.
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 1, 3-4, 6-8, 10-11, 13-15, 17-18, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Jestrabek-Hart (US 20010032648 A1) in view of Daugherty (US 20040226559 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 is configured to seal 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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Jestrabek-Hart fails to explicitly disclose the one or more exhaust air hoses surround the one or more intake air hoses, and wherein the one or more intake air hoses extend through the one or more exhaust air hoses along an entire length of the one or more exhaust air hoses.
However, Daugherty teaches an analogous unilimb breathing circuit (20; Fig. 1) with an outer expiratory tube (22; Fig. 1) coaxially arranged about an inner inspiratory tube (24; Figs. 1-2; [0047]), where the inner inspiratory tube (24) extends through the outer expiratory tube (22) along the entire length of the outer expiratory tube (see Fig. 1), and the unilimb breathing circuit (20) has a connector (26; Fig. 1) at the patient end to connect to an adapter (62; Fig. 1) of a face tent (60, see Fig. 1; [0050]). Daugherty further teaches the outer expiratory tube (22) and the inner inspiratory tube (24) connect to an outer port (32) and an inner port (34), respectively (Fig. 1; first two sentences of [0048]), to couple to a central oxygen gas source via a reverse flow adapter (40; Fig. 1; [0055]).
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 exhaust tube (30) and the inlet conduit (26), as taught by Jestrabek-Hart, with the outer expiratory tube (22) and inner inspiratory tube (24) of the unilimb breathing circuit (20), as taught by Daugherty above, and to modify the mask taught by Jestrabek-Hart to have the adapter (62) taught by Daugherty, such that the unilimb breathing circuit (Daugherty 20) and connect to the mask (34) via the connector (Daugherty 26) and the adapter (Daugherty 62), and that the one or more exhaust air hoses (Daugherty 22; Daugherty Fig. 1) surround the one or more intake air hoses (Daugherty 22 surrounds Daugherty 24, see Daugherty Figs. 1-2), and wherein the one or more intake air hoses (Daugherty 24) extend through the one or more exhaust air hoses along an entire length of the one or more exhaust air hoses (see Daugherty Figs. 1-2) to increase patient comfort during treatment by utilizing the expired gases flowing through the outer expiratory tube to warm and humidify the air being delivered to the patient through the inner inspiratory tube (Daugherty [0052]).
Regarding claim 3, Jestrabek-Hart as modified above teaches 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 a head, a neck, and an ear of the user (see Figs. 1-2).
Regarding claim 4, Jestrabek-Hart as modified above teaches the invention as set forth in claim 1, wherein the mask system comprises a plurality of exhaust ports to pass exhaust to the one or more exhaust air hoses (Daugherty 26 and 62; [0050], where, according to Merriam-Webster Dictionary, a port is defined as an opening for intake or exhaust of a fluid, hence the connector 26 and the adapter 62 can be interpreted as exhaust ports).
Regarding claim 6, Jestrabek-Hart as modified above teaches the invention as set forth in claim 4, wherein the one or more exhaust air hoses are coupled to the CPAP or BiPAP machine (Daugherty 22 can connect to CPAP machine taught by Jestrabek-Hart via the Daugherty 32 and 40; Daugherty Fig. 1; first two sentences of Daugherty [0048] and Daugherty [0055]).
Regarding claim 7, Jestrabek-Hart as modified above 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 one or more intake air hoses (Daugherty [0052]).
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 to the user and removing 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 is configured to seal 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 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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Jestrabek-Hart fails to explicitly disclose the one or more exhaust air hoses surround the one or more intake air hoses, and wherein the one or more intake air hoses extend through the one or more exhaust air hoses along an entire length of the one or more exhaust air hoses.
However, Daugherty teaches an analogous unilimb breathing circuit (20; Fig. 1) with an outer expiratory tube (22; Fig. 1) coaxially arranged about an inner inspiratory tube (24; Figs. 1-2; [0047]), where the inner inspiratory tube (24) extends through the outer expiratory tube (22) along the entire length of the outer expiratory tube (see Fig. 1), and the unilimb breathing circuit (20) has a connector (26; Fig. 1) at the patient end to connect to an adapter (62; Fig. 1) of a face tent (60, see Fig. 1; [0050]). Daugherty further teaches the outer expiratory tube (22) and the inner inspiratory tube (24) connect to an outer port (32) and an inner port (34), respectively (Fig. 1; first two sentences of [0048]), to couple to a central oxygen gas source via a reverse flow adapter (40; Fig. 1; [0055]).
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 exhaust tube (30) and the inlet conduit (26), as taught by Jestrabek-Hart, with the outer expiratory tube (22) and inner inspiratory tube (24) of the unilimb breathing circuit (20), as taught by Daugherty above, and to modify the mask taught by Jestrabek-Hart to have the adapter (62) taught by Daugherty, such that the unilimb breathing circuit (Daugherty 20) and connect to the mask (34) via the connector (Daugherty 26) and the adapter (Daugherty 62), and that the one or more exhaust air hoses (Daugherty 22; Daugherty Fig. 1) surround the one or more intake air hoses (Daugherty 22 surrounds Daugherty 24, see Daugherty Figs. 1-2), and wherein the one or more intake air hoses (Daugherty 24) extend through the one or more exhaust air hoses along an entire length of the one or more exhaust air hoses (see Daugherty Figs. 1-2) to increase patient comfort during treatment by utilizing the expired gases flowing through the outer expiratory tube to warm and humidify the air being delivered to the patient through the inner inspiratory tube (Daugherty [0052]).
Regarding claim 10, Jestrabek-Hart as modified above teaches 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 a head, a neck, and an ear of the user (see Figs. 1-2).
Regarding claim 11, Jestrabek-Hart as modified above teaches the invention as set forth in claim 8, wherein the mask system comprises a plurality of exhaust ports to pass exhaust to the one or more exhaust air hoses (Daugherty 26 and 62; [0050], where, according to Merriam-Webster Dictionary, a port is defined as an opening for intake or exhaust of a fluid, hence the connector 26 and the adapter 62 can be interpreted as exhaust ports).
Regarding claim 13, Jestrabek-Hart as modified above teaches the invention as set forth in claim 11, wherein the one or more exhaust air hoses are coupled to the CPAP or BiPAP machine (Daugherty 22 can connect to CPAP machine taught by Jestrabek-Hart via the Daugherty 32 and 40; Daugherty Fig. 1; first two sentences of Daugherty [0048] and Daugherty [0055]).
Regarding claim 14, Jestrabek-Hart as modified above 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 one or more intake air hoses (Daugherty [0052]).
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 is configured to seal 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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Jestrabek-Hart fails to explicitly disclose the one or more exhaust air hoses surround the one or more intake air hoses, and wherein the one or more intake air hoses extend through the one or more exhaust air hoses along an entire length of the one or more exhaust air hoses.
However, Daugherty teaches an analogous unilimb breathing circuit (20; Fig. 1) with an outer expiratory tube (22; Fig. 1) coaxially arranged about an inner inspiratory tube (24; Figs. 1-2; [0047]), where the inner inspiratory tube (24) extends through the outer expiratory tube (22) along the entire length of the outer expiratory tube (see Fig. 1), and the unilimb breathing circuit (20) has a connector (26; Fig. 1) at the patient end to connect to an adapter (62; Fig. 1) of a face tent (60, see Fig. 1; [0050]). Daugherty further teaches the outer expiratory tube (22) and the inner inspiratory tube (24) connect to an outer port (32) and an inner port (34), respectively (Fig. 1; first two sentences of [0048]), to couple to a central oxygen gas source via a reverse flow adapter (40; Fig. 1; [0055]).
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 exhaust tube (30) and the inlet conduit (26), as taught by Jestrabek-Hart, with the outer expiratory tube (22) and inner inspiratory tube (24) of the unilimb breathing circuit (20), as taught by Daugherty above, and to modify the mask taught by Jestrabek-Hart to have the adapter (62) taught by Daugherty, such that the unilimb breathing circuit (Daugherty 20) and connect to the mask (34) via the connector (Daugherty 26) and the adapter (Daugherty 62), and that the one or more exhaust air hoses (Daugherty 22; Daugherty Fig. 1) surround the one or more intake air hoses (Daugherty 22 surrounds Daugherty 24, see Daugherty Figs. 1-2), and wherein the one or more intake air hoses (Daugherty 24) extend through the one or more exhaust air hoses along an entire length of the one or more exhaust air hoses (see Daugherty Figs. 1-2) to increase patient comfort during treatment by utilizing the expired gases flowing through the outer expiratory tube to warm and humidify the air being delivered to the patient through the inner inspiratory tube (Daugherty [0052]).
Regarding claim 17, Jestrabek-Hart as modified above teaches 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 a head, a neck, and an ear of the user (see Figs. 1-2).
Regarding claim 18, Jestrabek-Hart as modified above teaches the invention as set forth in claim 15, wherein the mask system comprises a plurality of exhaust ports to pass exhaust to the one or more exhaust air hoses (Daugherty 26 and 62; [0050], where, according to Merriam-Webster Dictionary, a port is defined as an opening for intake or exhaust of a fluid, hence the connector 26 and the adapter 62 can be interpreted as exhaust ports).
Regarding claim 20, Jestrabek-Hart as modified above teaches the invention as set forth in claim 17, wherein the one or more exhaust air hoses are coupled to the CPAP or BiPAP machine (Daugherty 22 can connect to CPAP machine taught by Jestrabek-Hart via the Daugherty 32 and 40; Daugherty Fig. 1; first two sentences of Daugherty [0048] and Daugherty [0055]).
Claims 5, 12, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Jestrabek-Hart (US 20010032648 A1) in view of Daugherty (US 20040226559 A1) as applied to claims 4, 11, and 18 above, and further in view of Fukunaga et al. (US 20030183232 A1; hereinafter “Fukunaga”).
Regarding claim 5, Jestrabek-Hart as modified above teaches the invention as set forth in claim 4, but fails to teach the one or more exhaust air hoses are not coupled to the CPAP or BiPAP machine.
However, Fukunaga teaches an analogous breathing tube (5; Fig. 2A), where expiratory gases pass through a breathing lumen (54; Fig. 2A; last sentence of [0075]) and fresh gases travel through a fresh gas flow lumen (58; Fig. 2A) where the fresh gases are provided by a fresh gas source (1; Fig. 2A) to the fresh gas flow lumen (via 52 and 56, see Fig. 2A; first sentence of [0069]). Fukunaga further teaches a proximal terminal (50; Fig. 2A) connected to a flow splitting component (6; Fig. 2A) with an expiratory port (22; Fig. 2A) to receive the expiratory gases from the breathing tube (5), and allow the expiratory gases to be scrubbed in a recirculation module ([0070]).
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 unilimb breathing circuit, the outer port, and inner port, as taught by Daugherty in claim 1 above, with the breathing tube, proximal terminal, and recirculation module, as taught by Fukunaga above, such that the fresh gas flow lumen taught by Fukunaga (58; Fig. 2A) can connect to the CPAP device taught by Jestrabek-Hart (see claim 1; where Fukunaga 58 connects to Jestrabek-Hart’s CPAP via Fukunaga 52 and 56, see Fukunaga Fig. 2A; first sentence of Fukunaga [0069]), and the expiratory gases from the patient flow through the breathing lumen taught by Fukunaga (54; Fig. 2A; last sentence of [0075]) to the recirculation module taught by Fukunaga (see Fig. 2A; [0070]), not to the CPAP taught by Jestrabek-Hart, to improve patient safety during treatment by minimizing rebreathing of high concentrations of CO2 (Fukunaga [0032], lines 1-13).
Regarding claim 12, Jestrabek-Hart as modified above teaches the invention as set forth in claim 11, but fails to teach the one or more exhaust air hoses are not coupled to the CPAP or BiPAP machine.
However, Fukunaga teaches an analogous breathing tube (5; Fig. 2A), where expiratory gases pass through a breathing lumen (54; Fig. 2A; last sentence of [0075]) and fresh gases travel through a fresh gas flow lumen (58; Fig. 2A) where the fresh gases are provided by a fresh gas source (1; Fig. 2A) to the fresh gas flow lumen (via 52 and 56, see Fig. 2A; first sentence of [0069]). Fukunaga further teaches a proximal terminal (50; Fig. 2A) connected to a flow splitting component (6; Fig. 2A) with an expiratory port (22; Fig. 2A) to receive the expiratory gases from the breathing tube (5), and allow the expiratory gases to be scrubbed in a recirculation module ([0070]).
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 unilimb breathing circuit, the outer port, and inner port, as taught by Daugherty in claim 8 above, with the breathing tube, proximal terminal, and recirculation module, as taught by Fukunaga above, such that the fresh gas flow lumen taught by Fukunaga (58; Fig. 2A) can connect to the CPAP device taught by Jestrabek-Hart (see claim 8; where Fukunaga 58 connects to Jestrabek-Hart’s CPAP via Fukunaga 52 and 56, see Fukunaga Fig. 2A; first sentence of Fukunaga [0069]), and the expiratory gases from the patient flow through the breathing lumen taught by Fukunaga (54; Fig. 2A; last sentence of [0075]) to the recirculation module taught by Fukunaga (see Fig. 2A; [0070]), not to the CPAP taught by Jestrabek-Hart, to improve patient safety during treatment by minimizing rebreathing of high concentrations of CO2 (Fukunaga [0032], lines 1-13).
Regarding claim 19, Jestrabek-Hart as modified above teaches the invention as set forth in claim 18, but fails to teach the one or more exhaust air hoses are not coupled to the CPAP or BiPAP machine.
However, Fukunaga teaches an analogous breathing tube (5; Fig. 2A), where expiratory gases pass through a breathing lumen (54; Fig. 2A; last sentence of [0075]) and fresh gases travel through a fresh gas flow lumen (58; Fig. 2A) where the fresh gases are provided by a fresh gas source (1; Fig. 2A) to the fresh gas flow lumen (via 52 and 56, see Fig. 2A; first sentence of [0069]). Fukunaga further teaches a proximal terminal (50; Fig. 2A) connected to a flow splitting component (6; Fig. 2A) with an expiratory port (22; Fig. 2A) to receive the expiratory gases from the breathing tube (5), and allow the expiratory gases to be scrubbed in a recirculation module ([0070]).
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 unilimb breathing circuit, the outer port, and inner port, as taught by Daugherty in claim 15 above, with the breathing tube, proximal terminal, and recirculation module, as taught by Fukunaga above, such that the fresh gas flow lumen taught by Fukunaga (58; Fig. 2A) can connect to the CPAP device taught by Jestrabek-Hart (see claim 15; where Fukunaga 58 connects to Jestrabek-Hart’s CPAP via Fukunaga 52 and 56, see Fukunaga Fig. 2A; first sentence of Fukunaga [0069]), and the expiratory gases from the patient flow through the breathing lumen taught by Fukunaga (54; Fig. 2A; last sentence of [0075]) to the recirculation module taught by Fukunaga (see Fig. 2A; [0070]), not to the CPAP taught by Jestrabek-Hart, to improve patient safety during treatment by minimizing rebreathing of high concentrations of CO2 (Fukunaga [0032], lines 1-13).
Response to Arguments
Applicant’s arguments with respect to claims ---1, 8, and 15 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
On page 7 of the Remarks (filed on 04/15/2026), Applicant argues Jestrabek-Hart fails to disclose “wherein the one or more exhaust air hoses surround the one or more intake air hoses, and wherein the one or more intake air hoses extend through the one or more exhaust air hoses along an entire length of the one or more exhaust air hoses”, as recited in amended independent claims 1, 8, and 15. While the Examiner agrees, Applicant’s argument is moot as the amendment of the limitation “wherein the one or more exhaust air hoses surround the one or more intake air hoses, and wherein the one or more intake air hoses extend through the one or more exhaust air hoses along an entire length of the one or more exhaust air hoses” to independent claims 1, 8, and 15 changes the scope of said independent claims. As such, new ground(s) of rejection are necessitated by the amendments. Daugherty has been presented to teach the amended limitation in independent claims 1, 8, and 15, as Daugherty teaches a unilimb breathing circuit (20) with an outer expiratory tube (22) and an inner inspiratory tube (24) that extends through the full length of the expiratory tube (see Fig. 1; see rejection of claims 1, 8, and 15 under 35 U.S.C. 103 above).
On pages 9-12 of the Remarks, with regard to claims 2, 9, and 16, Applicant argues Jestrabek-Hart fails to teach or disclose “the one or more exhaust air hoses surround the one or more intake air hoses, and wherein the one or more intake air hoses extend through the one or more exhaust air hoses along an entire length of the one or more exhaust air hoses”, and neither Lurie nor Lalonde cure this deficiency. Claims 2, 9, and 16 have been canceled in the amendment filed on 04/15/2026; hence, Applicant’s argument is not persuasive. While amended claims 1, 8, and 15 now include similar limitations to the limitations recited in claims 2, 9, and 16 (before said claims were canceled), Jestrabek-Hart, Lurie, and Lalonde are not relied upon to teach the amended limitation of “wherein the one or more exhaust air hoses surround the one or more intake air hoses, and wherein the one or more intake air hoses extend through the one or more exhaust air hoses along an entire length of the one or more exhaust air hoses”. Daugherty is now relied upon to teach a unilimb breathing circuit (20) with an outer expiratory tube (22) and an inner inspiratory tube (24) that extends through the full length of the expiratory tube (see Fig. 1; see rejection of claims 1, 8, and 15 under 35 U.S.C. 103 above).
In regard to claims 4-7, 11-14, and 18-20, Applicant argues Lalonde fails to cure Jestrabek-Hart’s deficiency of failing to teach air intake hoses extending through exhaust hoses along an entire length of the exhaust air hoses (see pgs. 13-15 of Remarks). However, Daugherty is now relied upon to teach an inner inspiratory tube (24) that extends through the full length of an expiratory tube (22; see Fig. 1; see rejection of claims 1, 8, and 15 under 35 U.S.C. 103 above). Hence, Applicant’s argument is not persuasive.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Winkler et al. (US 20230173215 A1): Regarding a medical airway device with an inner inspiratory tube coaxially aligned with an outer expiratory tube, where the inner inspiratory tube extends the full length of the outer expiratory tube.
Frede (GB 2465358 A): Regarding a nasal CPAP device with a breathing having an outer expiratory tube and an inner inhalation/fresh gas tube extending the full length of the outer expiratory tube.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/ABIGAYLE DALE/Examiner, Art Unit 3785
/BRANDY S LEE/Supervisory Patent Examiner, Art Unit 3785