DETAILED ACTION
This office action is in response to the claims filed 7/21/2023. Claims 1-15 are presenting pending in this application.
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 § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim(s) 1-6 is/are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention.
Claim 1 recites the limitation "the first conduit" in line 4. There is insufficient antecedent basis for this limitation in the claim. For purposes of examination, it is considered that the limitation “the first conduit” refers back to the previously recited outer conduit.
Claims 2-6 are rejected for being either directly or indirectly depending from a rejected claim base.
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 of this title, 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.
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 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.
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) 1-3 and 5-6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Petrochenko et al (2020/0398014) in view of Milne et al (2016/0045702).
Regarding claim 1, Petrochenko in fig 8 discloses a patient breathing circuit (801) (coaxial tube) comprising: an outer conduit (811) (para [0134]) having a first end (left end) connectable to a patient interface (includes patient end connector (815), which is connected to a patient (810)) (para [0134]) and a second end (right end) connectable to a ventilator (para [0134])); an inner conduit (807) positioned within the first conduit (811) (para [0134]), wherein a first lumen (813) (space) is defined within an interior of the inner conduit (807) (para [0135]) and a second lumen (809) (second space) is defined between an exterior of the inner conduit (807) and an interior of the outer conduit (811) (para [0134]); a first heater wire coupled to the inner conduit (807) (resistance heater filament may be provided within either the inner tube (807) or outer tube (811) or disposed within the gases spaces (809) or (813)) (para [0138]), and an expiratory extension having a first end extending from the outer conduit (811) and a second end connectable to an expiratory port of a ventilator (805) (as shown in fig 8, breathing circuit (801) includes an extension extending from an upper right portion of outer conduit (811) and connected to an expiratory port of a ventilator (805) (para [0134]), wherein a heater may be provided within the expiratory portion of the breathing circuit (para [0138]), and Petrochenko fig 1 discloses an inspiratory tube (103) having a first end connectable to a patient interface (115) and second end connectable to a humidifier (107) (fig 1, para [0056]), and therefore the Petrochenko’s device discloses that the proximal end of the outer conduit (811) would be physically connected to a humidifier by the inner conduit (807) (fig 8, para [0134]).
Petrochenko does not disclose the expiratory extension is a boost-heated expiratory extension wherein the boost-heated expiratory extension includes at least one of a second heater wire or a metallic post for heating gases flowing through the boost-heated expiratory extension.
However, Milne in fig 8 teaches a respiratory device including a drying expiratory limb (210) including multiple heater sections which can be selectively controlled by a controller (122) through connectors (216a, b) (para [0088]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the invention to modify the device of Petrochenko by providing the expiratory portion of breathing circuit with multiple heating sections including at least a first and second heater connected by a connector to selectively supply power to the heater sections as taught by Milne in order to allow the device to selectively provide electrical power to heat the gas in the expiratory has to control the temperature drop of the gas to increase drying of the gas or to be above the dew point by a targeted amount (Milne, para [0012]).
The now-modified Petrochenko’s device discloses the expiratory portion includes multiple heated portions to selectively receive electrical power to heat gases in the expiratory portion; however, modified Petrochenko does not disclose that the expiratory extension includes a heated portion comprising at least one of a second heater wire or a metallic post.
However, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the invention to modify the device of modified Petrochenko so that the expiratory portion includes a second heater wire to selectively receive electrical power to heat gases in the expiratory portion, as it would be an obvious rearrangement of parts, as the feature of providing multiple heated sections in an expiratory portion of a breathing circuit is known in the art, the expiratory extension is an element of the expiratory portion, and therefore would be expected to perform equally well to heat expiratory gases passing through the expiratory extension. See MPEP 2144.04(VI)(C).
Regarding claim 2, Petrochenko disclose the first lumen (813) is configured to carry humidified breathing gases from the humidifier to the patient interface (805) (para [0135]); and the second lumen (809) is configured to carry exhaled gases from the patient interface (805) to the boost-heated expiratory extension (para [0134]).
Regarding claim 3, the modified Petrochenko’s references discloses a third heater wire coupled to the outer conduit (expiratory portion of the breathing circuit may include multiple heated segments (Milne, para [0088]), and resistance heater filament may be provided within the outer tube (811 of Petrochenko) or disposed within the gases spaces (809 of Petrochenko)) (Petrochenko, para [0138]).
Regarding claim 5, the modified Petrochenko’s reference discloses the boost-heated expiratory extension includes the second heater wire (as shown in fig 8 of Milne, distal portion of expiratory limb (210) has a heater wire, and as discussed above, the boost-heated expiratory extension is at the distal portion of the expiratory limb and includes the second heater wire (Milne, fig 8, para [0089]).
Regarding claim 6, modified Petrochenko discloses an outer conduit (811 of Petrochenko) and a boost-heated expiratory extension connected to ventilator (805 of Petrochenko) (Petrochenko, fig 8, para [0134]), and as shown in fig 8 of Petrochenko, the boost-heated expiratory extension is shown to have a second length that is less than 50% of the first length of the outer conduit (811 of Petrochenko).
In the alternative, although modified Petrochenko does not explicitly disclose that the second length is less than 50% of the first length, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the invention to modify the relative lengths of the outer conduit and the boost-heated expiratory extension so that the second length is less than 50% of the first length, as it has been held that changes in sizes and shape, and optimization of ranges, are within the level of skill of one of ordinary skill in the art. Therefore, modifying the lengths of the outer conduit and the boost-heated expiratory extension by routine experimentation would have been an obvious modification to allow the multiple heated segments to be of a suitable size for the device to selectively apply heat to different segments of the expiratory portion of the breathing circuit to provide a tailored temperature profile (Milne, abstract).
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Petrochenko et al and Milne et al as applied to claim 1 above, and further in view of Novkov (2019/0344038).
Regarding claim 4, modified Petrochenko discloses a boost-heated expiratory extension including a heater wire (Milne, para [0088]).
Modified Petrochenko does not disclose the boost-heated expiratory extension includes the metallic post.
However, Novkov teaches a respiratory circuit including a short conduit that can be provided in an expiratory limb of a respiratory (heating tube (not shown) may be placed on an exhalation side), wherein the short conduit includes a metallic post (119) (heating tube (119) may be a tube (hollow post) made of a thermally conductive metal or alloy) heated by a heating element (not shown) (para [0039]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the invention to modify the device of modified Petrochenko by substituting the heating wire heating mechanism of the boost-heated expiratory extension with a heating mechanism comprising a metallic post comprising a heating tube made of a suitable metal or alloy and heated by a heating element as taught by Novkov, as it would be a substitution of one known heating mechanism known in the art to heat an expiratory limb of a breathing circuit to prevent rainout (Novkov, para [0039]), and it appears that the device of modified Petrochenko would perform equally well to heat the boost-heated expiratory extension to prevent rainout in the circuit. See MPEP 2143(I)(A).
Claim(s) 7-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Milne et al in view of Novkov.
Regarding claim 7, Milne in fig 1 teaches a patient breathing circuit comprising: an expiratory conduit (210) (expiratory limb) for carrying expiratory gases from a patient interface (115) towards an expiratory port of a ventilator (102) (gases source) (para [0065]), and as shown in fig 8, the expiratory limb (210) including multiple heater sections including a heater wire section at a proximal portion of the expiratory limb (210) for carrying expiratory gases from the expiratory conduit towards to the expiratory port (para [0088]).
Milne does not disclose the heating section includes a metallic post connectable to the expiratory conduit for carrying expiratory gases from the expiratory conduit towards to the expiratory port; and a heater coupled to the metallic post to heat the metallic post.
However, Novkov teaches a patient breathing circuit comprising: an expiratory conduit (137) (expiratory limb) for carrying expiratory gases from a patient interface (180) towards an expiratory port of a ventilator (102) (pneumatic system) (para [0028]); a metallic post (119) (heating tube may be made of a suitable metal or alloy) for carrying expiratory gases (second heating tube (not shown) may be placed on an expiration side for carrying expiratory gases, and a heater (heating element) coupled to the metallic post (119) to heat the metallic post (119) (para [0039]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the invention to modify the device of Milne by substituting the heating wire heating mechanism with a heating mechanism including a metallic post connectable to the expiratory conduit for carrying expiratory gases from the expiratory conduit towards to the expiratory port; and a heater coupled to the metallic post to heat the metallic post as taught by Novkov, as it would be a substitution of one known heating mechanism known in the art to heat an expiratory portion of a breathing circuit to prevent rainout (Novkov, para [0039]), and it appears that the device of modified Milne would perform equally well to heat the expiratory portion to prevent rainout in the circuit by providing a metallic post connectable to the expiratory conduit for carrying expiratory gases from the expiratory conduit towards the expiratory port. See MPEP 2143(I)(A).
Regarding claim 8, the modified Milne’s reference discloses the metallic post (119 of Novkov) has a length that is less than or equal to 6 inches (2 to 5 inches long) (Novkov, para [0039]).
Regarding claim 9, modified Milne discloses the heater is configured to heat the metallic post (119 of Novkov) (Novkov, para [0039]).
Modified Milne does not disclose the heater is configured to heat the metallic post to a temperature greater than 50 degrees Celsius.
However, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the invention to modify the device of modified Milne to configure the heater heat the metallic post to a temperature greater than 50 degrees Celsius, as it has been held that optimization of ranges are within the level of skill of one of ordinary skill in the art. Therefore, modifying the temperature that the heater is configured to heat the metallic post by routine experimentation would be an obvious modification to prevent rainout in the expiratory portion of the breathing circuit (Novkov, para [0039]).
Regarding claim 10, modified Milne discloses a metallic post.
Modified Milne does not disclose an insulating cover covering the metallic post.
However, Milne in figs 3-4 teaches an expiratory circuit (210), wherein the expiratory circuit (210) includes an insulating material (214) covering the expiratory circuit (210) (para [0082]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the invention to modify the device of modified Milne by providing an insulating cover covering the expiratory tube as taught by Milne in order to provide insulation to control the temperature of gas along the tube (Milne, para [0082]). The now-modified Milne’s device is considered that the insulating cover covers the metallic post, as the insulation (214 of Milne) is disposed on the outside of the expiratory circuit, and therefore would cover the metallic post disposed in the expiratory circuit.
Claim(s) 11-12 and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Petrochenko et al in view of Milne et al and Borsari (2019/0358423).
Regarding claim 11, Petrochenko in fig 8 discloses a device whose ordinary use discloses the method for controlling heating within a concentric patient breathing circuit (801) (coaxial tube) shown in fig 8 including an inspiratory conduit (813) concentrically positioned within an expiratory conduit (809) and including a first heater wire within the inspiratory conduit (813) and a second heater wire within the expiratory conduit (809) (para [0138]), an expiratory extension having a first end extending from the outer conduit (811) and a second end connectable to an expiratory port of a ventilator (805) (as shown in fig 8, breathing circuit (801) includes an extension extending from an upper right portion of outer conduit (811) and connected to an expiratory port of a ventilator (805) (para [0134]), and in fig 1 discloses receiving a first temperature measurement (via temperature sensor (135)) of breathing gases flowing through the inspiratory conduit (103) of the breathing circuit coupled to a patient interface (115); based on the first temperature measurement, generating a first heater wire control signal for a first heater wire coupled to the inspiratory conduit (103), the first heater wire control signal configured to cause breathing gases entering the patient interface (115) to reach a patient-specific temperature (para [0061]), and receiving a second temperature measurement for exhaled gases flowing through the expiratory conduit (117), and generating a second control signal for controlling a heater wire, the control signal configured to heat exhaled gases entering the expiratory conduit (117) (expiratory tube (117) may have a temperature sensor and/or heating element, such as a heater wire to adjust a temperature of gases flowing through the expiratory tube (para [0062]).
Modified Petrochenko does not disclose the expiratory extension is a boost-heated expiratory extension, wherein the method comprises receiving a second temperature measurement for exhaled gases flowing through a boost- heated expiratory extension, the boost-heated expiratory extension extending from the expiratory conduit to an expiratory port of a ventilator; and generating a boost control signal for controlling at least one of a heater wire or a heater of the boost-heated expiratory extension, the boost control signal configured to heat exhaled gases entering the expiratory port to a heat-boosted target temperature.
However, Milne in fig 8 teaches a respiratory device including a drying expiratory limb (210) including multiple heater sections which can be selectively controlled by a controller (122) through connectors (216a, b) (para [0088]), wherein the method comprises receiving a temperature measurements for exhaled gases flowing through each of the heater segments via connectors (216a, b), and generating a boost control signal for controlling a heater wire of each of the heater segments, the boost control signal configured to heat exhaled gases entering the expiratory port to a heat-boosted target temperature (connectors (216a, b) couple the heater segments and allow the controller to selectively apply heat to different sections of the drying expiratory limb, and each connector, and connectors (216a, b) are configured to allow temperature sensors (not shown) to enable a controller (122) to acquire their respective outputs) (para [0089]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the invention to modify the method of Petrochenko by providing the expiratory portion of breathing circuit with multiple heating sections including at least a first and second heater connected by a connector to selectively supply power to the heater sections, wherein the method comprises receiving a second temperature measurement for exhaled gases flowing through each of the heater segments; and generating a boost control signal for controlling at least one of a heater wire or a heater of the heater segments, the boost control signal configured to heat exhaled gases entering the expiratory port to a heat-boosted target temperature as taught by Milne in order to allow the device to selectively provide electrical power to heat the gas in the expiratory has to control the temperature drop of the gas to increase drying of the gas or to be above the dew point by a targeted amount (Milne, para [0012]).
The now-modified Petrochenko’s method discloses the expiratory portion includes multiple heated segments to selectively receive electrical power to heat gases in the expiratory portion; however, modified Petrochenko does not disclose that the expiratory extension includes at least one of a second heater wire or a heater.
However, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the invention to modify the device of modified Petrochenko so that the expiratory portion includes a second heater wire to selectively receive electrical power to heat gases in the expiratory portion, as it would be an obvious rearrangement of parts, as the feature of providing multiple heated sections in an expiratory portion of a breathing circuit is known in the art, the expiratory extension is an element of the expiratory portion, and therefore would be expected to perform equally well to heat expiratory gases passing through the expiratory extension. See MPEP 2144.04(VI)(C).
The now-modified Petrochenko’s device does not disclose the heat-boosted target temperature being at least 5 degrees Celsius greater than the patient-specific temperature.
However ,Borsari teaches a respiratory device including a an inhalation tube (120) including a heating element (123) (para [0042]), an expiratory tube (140) including a heating element (143) (para [0044]), wherein a temperature of the expiratory tube (140) is configured to heat the exhalation tube (140) to a temperature greater than a patient-specific temperature (air inside the inhalation tube (140) is heated to a greater value as that inhaled by a person) (para [0067]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the invention to modify the method of modified Petrochenko so that heat-boosted target temperature is greater than the patient-specific temperature as taught by Borsari in order to provide a suitable temperature to avoid condensation in the exhalation circuit, and heating an exhalation gas to a higher temperature would provide no problem to the patient (Borsari, para [0067]).
The now-modified Petrochenko’s method disclose the heat-boosted target temperature is greater than the patient-specific temperature (Borsari, para [0067]); however, modified Petrochenko does not disclose the heat-boosted target temperature is at least 5 degrees Celsius greater than the patient-specific temperature.
However, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the invention to modify the method of modified Petrochenko so that the heat-boosted target temperature is at least 5 degrees Celsius greater than the patient-specific temperature, as it has been held that optimization of ranges is within the level of skill of one of ordinary skill in the art. Therefore, modifying the heat-boosted target temperature by routine experimentation would have been an obvious modification to provide a suitable temperature to avoid condensation in the exhalation circuit, and heating an exhalation gas to a higher temperature would provide no problem to the patient (Borsari, para [0067]).
Regarding claim 12, the modified Petrochenko’s references discloses generating a second heater wire control signal for a second heater wire coupled to the expiratory conduit (second heater wire is coupled to expiratory conduit (813 of Petrochenko) (Petrochenko, para [0138]), and controller to selectively apply heat to different sections of the drying expiratory limb (210 of Milne) (Milne, para [0089])).
Regarding claim 15, modified Petrochenko discloses provide a heat-boosted target temperature.
Modified Petrochenko does not disclose the heat-boosted target temperature is at least 45 degrees Celsius and less than 60 degrees Celsius.
However, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the invention to modify the method of modified Petrochenko so that the heat-boosted target temperature is at least 45 degrees Celsius and less than 60 degrees Celsius, as it has been held that optimization of ranges is within the level of skill of one of ordinary skill in the art. Therefore, modifying the heat-boosted target temperature by routine experimentation would have been an obvious modification to provide a suitable temperature to avoid condensation in the exhalation circuit, and heating an exhalation gas to a higher temperature would provide no problem to the patient (Borsari, para [0067]).
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Petrochenko et al, Milne et al, and Borsari as applied to claim 12, and further in view of Forrester et al (2020/0330718).
Regarding claim 13, modified Petrochenko discloses a second heater wire control signal.
Modified Petrochenko does not disclose the second heater wire control signal is based on the first temperature measurement.
However, Forrester in fig 2a teaches a respiratory circuit including a first heater wire coupled to an inspiratory conduit (1200) and a second heater wire coupled to an expiratory conduit (1600) (para [0066]), a temperature sensor (930) configured to receive a first temperature measurement of gases flowing through the inspiratory conduit (1200) coupled to a patient interface (940) (para [0069]), wherein the device is configured to provide a second heater wire control signal to the second heater wire (1600) based on the first temperature measurement (930) (device may selectively turn on and off the provision of electric power to heating wires within the expiratory hose (1600) to selectively apply heat thereto based on the temperature sensed by the temperature sensor (930)) (para [0075]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the invention to modify the method of modified Petrochenko so that the second heater wire control signal is based on the first temperature measurement as taught by Forrester in order to provide a known control mechanism for controlling the heating of gases to prevent condensation from occurring within the expiratory hose (Forrester, para [0076]).
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Petrochenko et al, Milne et al, and Borsari as applied to claim 12, and further in view of Liu et al (2018/0280651).
Regarding claim 14, modified Petrochenko discloses a first heater wire control signal.
Modified Petrochenko does not disclose the first heater wire control signal is a pulse-width-modified (PWM) signal.
However, Liu teaches a respiratory circuit including an inspiratory limb (202) including a plurality of heater wires (206, b), wherein the heater wires (206a, b) is controlled using control signal comprising a pulse-width-modified (PWM) signal (para [0112]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the invention to modify the method of modified Petrochenko so that the first heater wire control signal is a pulse-width-modified (PWM) signal as taught by Liu in order to allow a duty cycle to the control signal to control the power delivered to the heater wire (Liu, para [0112]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: Bedford et al (2012/0125333) and Buechi et al (2014/0311487) disclose heated respiratory circuits, and Chua (4,967,744), Suzuki (4,463,755), and Smith et al (6,536,428) disclose coaxial breathing circuits.
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/DOUGLAS Y SUL/Examiner, Art Unit 3785
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