DETAILED ACTION
This office action is responsive to the amendment filed 9/24/2025. As directed, claim 69, 71, 78, 82, 84, 86, and 87 has been amended, claims 75-77, 80, 83, 85, and 88 have been canceled, and claim 89 has been added. Thus claims 69-74, 78, 79, 81, 82, 84, 86, 87, and 89 are currently pending.
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 § 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.
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) 69, 71-73, 82, 86, 87, and 89 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hardin et al (2013/0199524) in view of Barnes (3,667,463) and Coleman et al. (2014/0158130).
Regarding claims 69 and 87, Hardin discloses a respiratory assistance system, comprising an inspiratory conduit (4) and a humidification chamber (26, 27); a cap (i.e. spring loaded covers 56, 58) configured to close a conduit (54) of the respiratory assistance system, a bypass adaptor (30) configured to enable the inspiratory conduit (4) to be connected between a gases source (22) and a patient interface (42; patient interface) to bypass the humidification device (26), the bypass adaptor (30) comprising: an inlet connector (60) configured to be directly and removably connected to an outlet (28 or 48) of the gases source ([0005] lines 1-4; [0032] lines 1-5 disclose the valve can be disconnected for cleaning and reuse and [0033] lines 10-15 disclose the valve can be directly connected to ventilator outlet 28 and/or 48) and configured to not connect to an outlet (i.e. male outlet connector 80) of the humidification chamber (i.e. [0029] discloses that both outlet connector 60 and outlet connector 80 are male connectors and therefore unable to directly connect; see [0029] lines15-20 and 40-45); an outlet connector (68) configured to be directly and removably connected to a connector (40) of the inspiratory conduit (4) ([0005] lines 1-4; [0032] lines 1-5 disclose the valve can be disconnected for cleaning and reuse) and configured to not connect to an outlet (i.e. male outlet connector 80) of the humidification chamber (i.e. [0029] discloses that both outlet connector 68 and outlet connector 80 are male connectors and therefore unable to directly connect; see [0029] lines15-20 and 40-45); and a hollow body (54, 66) defining a gas flow path between the inlet connector and the outlet connector (fig; 4 54, 66) but does not specifically disclose wherein the inlet connector is different from the outlet connector in at least an inner or outer diameter. However, Barnes teaches the inlet connector (30 and/or 42) is different from the outlet connector (38) in a diameter (as shown, connectors i.e. 42, 30, 38 have smaller diameters than the larger connector mouth of the top of the humidifier 12, 14); the external diameter of the inlet connector is different from the respective external diameter of the outlet connector (as shown, the external diameter of tube 300 is larger having a square outlet and while the internal diameter is smaller). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the connectors of Hardin to be physically different as taught by Barnes to provide the advantage of enhanced identification of connectors for prevention of accidental connection and/or reconnection i.e. during assembly or after cleaning/maintenance.
Hardin discloses an interface connector (42) configured to form a connection between an end of the inspiratory conduit (4) and the cap (i.e. valve covers of the bypass adaptor) but does not specifically disclose and an expiratory conduit. However, Coleman teaches an expiratory conduit (130). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided the circuit of Hardin with an expiratory conduit as taught by Coleman to provide the advantage of enhanced separation of flows and expiratory recovery for monitoring.
Regarding claim 70, the modified Hardin teaches (see fig. 2 of Barnes) a shape of the inlet connector (30) is different from a shape of the outlet connector (38).
Regarding claim 71, the modified Hardin teaches (see fig. 2 of Barnes)each of the inlet connector (30 and the outlet connector (38) is tubular.
Regarding claim 72, the modified Hardin teaches (see fig. 2 of Barnes) a length of the inlet connector is different from a length of the outlet connector (as shown in figs. 2, connector 30 is taller).
Regarding claim 73, the modified Hardin teaches (see fig. 2 of Barnes) at least one of the inlet connector (42) tapers along its length.
Regarding claim 74, the modified Hardin teaches (see fig. 2 of Barnes) each of the inlet connector (i.e. 42) and the outlet connector 938) is tapered, and the taper on the inlet connector is different from the taper on the outlet connector (as shown, the connector 38 is tapered at the distal end different from taper of 42).
Regarding claim 82, Hardin discloses a conduit retainer (i.e. connector) such that the bypass adaptor (30) can be retained on or to the inspiratory conduit (as shown, the connectors are retained on the respective conduits) when not connected to the outlet of the gases source (i.e. the connector is able to connect the adaptor the inspiratory conduit even when removed from the gases source).
Regarding claim 86, Hardin discloses a supply conduit (28) configured to be connected between a gases source (22) and the humidification device (26).
Regarding claim 89, Hardin discloses wherein the bypass adaptor is configured to enable the gases source to conduct a test without the humidification chamber connected ([0005] lines 1-4; [0032] lines 1-5 disclose the valve can be disconnected for cleaning and reuse and [0033] lines 10-15 disclose the valve can be directly connected to ventilator outlet 28 and/or 48 such that the gases source is able to conduct a test without the humidifier connected since it is removable).
Claim(s) 78, 79, and 81 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hardin et al in view of Barnes and Coleman, as applied to claim 69 above, and further in view of Bedford (2012/0125333).
Regarding claim 78, Hardin discloses each of the inlet connector(38) and the outlet connector (40) is elongate and has a respective longitudinal axis, and the longitudinal axis of the inlet connector is not aligned with the longitudinal axis of the outlet connector (as shown, the connectors are parallel and not on the same line) and substantially teaches the claimed invention except for the longitudinal axis of the inlet connector is at an obtuse angle relative to the longitudinal axis of the outlet connector. However, Bedford teaches in fig. 6 longitudinal axis of the inlet connector (54) is at an obtuse angle relative to the longitudinal axis of the outlet connector (52) (as shown, the tubes are at an obtuse angle). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided the circuit of Hardin with obtuse angles tubes as taught by McCauley to provide the advantage of enhanced discernment of tubes.
Regarding claims 79 and 81, the modified Hardin discloses an obtuse angle (fig. 6; Bedford) but does not specifically discloser the angle between the longitudinal axis of the inlet connector from the longitudinal axis of the outlet connector is between about 110 degrees and about 160 degrees; the angle between the longitudinal axis of the inlet connector from the longitudinal axis of the outlet connector is between about 110 degrees and about 145 degrees; nor the angle between the longitudinal axis of the inlet connector from the longitudinal axis of the outlet connector is about 112 degrees. However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided the circuit of Hardin with obtuse angles within the claimed range as such would be considered a design choice easily implementable by one of ordinary skill. In addition it has been held that where the general conditions of ca claim are known, it is not inventive to determine optimumor workable ranges by routine experimentation.
Claim(s) 84 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hardin et al in view of Barnes and Coleman, as applied to claim 82 above, and further in view of McCauley (2012/0204870).
Regarding claim 84, Hardin substantially teaches the claimed invention except for a conduit retainer comprises a ring through which the inspiratory conduit or another conduit is received or a spring clip defining a variable size mouth configured to receive the inspiratory conduit or the other conduit, the mouth being biased to a condition in which the mouth retains the inspiratory conduit. However McCauley teaches a conduit retainer comprises a ring through which the inspiratory conduit or another conduit is received ([1206]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided the circuit of Hardin with a retaining ring as taught by McCauley to provide the advantage of enhanced tube patency and protection against accidental disconnection.
Response to Arguments
Applicant's arguments filed 9/24/2025 have been fully considered but they are not persuasive.
Applicant argues on page 6 1st-3rd paragraphs that Hardin does not disclose a cap and adapter as claimed. Examiner respectfully disagrees as Hardin discloses hinged covers 56, 58 as cap of an adapter in the form of bypass valve housing (30). As shown in fig. 4, the adapter 30 includes a manifold enabling the inspiratory conduit 4 to be connected between a gases source 22 and patient interface 42 wherein the inlet connector (38) of the valve adapter is directly connected to an outlet (28 or 48) of the gas source ([0026] last 15 lines). Further, Hardin discloses disconnection at least during transport of the patient and to bypass the humidifier ([(0016] lines 1-10, [0033] last 4 lines, [0035] lines 1-10). In addition Hardin discloses in [0005] lines 1-4, [0032] lines 1-5 disclose the valve can be disconnected for cleaning and reuse and [0033] lines 10-15 disclose the valve can be directly connected to ventilator outlet 28 and/or 48. Thus Hardin teaches a removable connection as claimed.
Conclusion
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LATOYA M LOUIS whose telephone number is (571)270-5337. The examiner can normally be reached M-F 1 pm - 6:30 pm ET.
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/LaToya M Louis/Primary Examiner, Art Unit 3785