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 .
Status of Claims
The present Office action is responsive to the application as filed on 11-02-2023. As directed, claims 1-26 are currently pending examination.
Claim Objections
Claims 1-3, 8-9, 11, 15-18, and 21 are objected to because of the following informalities:
At claim 1, line 8, it is suggested that “a flow controller” be replaced with “at least one flow controller” to avoid confusion with respect to claim 8.
At claim 1, line 9, it is suggested that “the product gas flow” be replaced with “a product gas flow” as the limitation has not been introduced.
At claim 2, line 2, it is suggested that “the flow controller” be replaced with “the at least one flow controller” in accordance with a previous suggestion for claim 1.
At claim 3, line 1, it is suggested that “provides” be replaced with “is configured to provide” to avoid recitation of method steps in an apparatus claim.
At claim 8, line 2, it is suggested that “the flow controller” be replaced with “the at least one flow controller” in accordance with a previous suggestion for claim 1.
At claim 9, line 1, it is suggested that “a flow of” be eliminated as a flow of each of the product and reactant gas was already introduced in claim 1.
At claim 9, line 2, it is suggested that “one or” be replaced with “one of” for clarity.
At claim 9, line 2, it is suggested that “the” be added before “product gas” for clarity.
At claim 11, line 1, it is suggested that “a pressure” be replaced with “the pressure” as the plasma chamber pressure was introduced in claim 10, from which claim 11 depends.
At claim 15, line 1, it is suggested that “a” before “flow” be eliminated because “the product gas flow” of claim 1 could reasonably overlap with the flow claimed in claim 15.
At claim 16, line 1, it is suggested that “The flow controller” be replaced with “the at least one flow controller” in accordance with a previous suggestion for claim 1.
At claim 17, line 1, it is suggested that “The flow controller” be replaced with “the at least one flow controller” in accordance with a previous suggestion for claim 1.
At claim 18, line 7, it is suggested that “the product gas flow” be replaced with “a product gas flow” as the limitation has not been introduced.
At claim 21, line 1, it is suggested that “provides” be replaced with “is configured to provide” to avoid recitation of method steps in an apparatus claim.
Appropriate correction is required.
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.
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 non-obviousness.
Claims 1, 4-11, 14-19, and 22-26 are rejected under 35 U.S.C. 103 as being unpatentable over Zapol (US 2018/0243527).
Regarding claim 1, Zapol discloses a nitric oxide (NO) generation system (paragraph 120, lines 1-2; paragraph 580, lines 1-24; Fig. 88), comprising:
one or more plasma chambers (1110+1112) configured to ionize a reactant gas to generate a plasma for producing a product gas containing nitric oxide (NO) using a flow of the reactant gas through the one or more plasma chambers (1110+1112) (paragraph 580, lines 15-21; note paragraph 5, lines 6-14, paragraph 184, lines 4-6 for explanation of plasma generation in plasma chambers, ad paragraph 336, lines 1-4; Fig. 88);
a scrubber reservoir (see each of FSFs in Fig. 88) downstream of the one or more plasma chambers (1110+1112), the scrubber reservoir (see each one of FSFs in Fig. 88) being configured to remove NO2 from the product gas and store the product gas therein (paragraph 580, lines 18-21; Fig. 88; see also paragraph 19, lines 4-6 for explanation of NO2 removal in a scavenger cartridge from generated nitric oxide; note that the product gas is at least stored in the FSF while it travels therethrough).
While Zapol indicates the presence of check valves downstream of the scrubber reservoir (see each of FSFs in Fig. 88) (paragraph 580, lines 21-24; Fig. 88), in this embodiment Zapol fails to explicitly disclose a flow controller positioned downstream of the scrubber reservoir, the flow controller having at least one setting to allow the product gas flow entering the scrubber reservoir to be greater than the product gas flow exiting the scrubber reservoir such that a pressure of the product gas in the scrubber reservoir increases.
However, Zapol separately teaches that in certain embodiments, a flow controller (see “flow restriction”) can be positioned downstream of the scrubber reservoir (see “scavenger”) (paragraph 578, lines 10-15; paragraph 680, lines 22-26; note also paragraph 185, lines 1-7 which expressly teaches that a flow restriction has the purpose of raising “the upstream pressure and density”), the flow controller (see “flow restriction”) having at least one setting to allow the product gas flow entering the scrubber reservoir (see “scavenger”) to be greater than the product gas flow exiting the scrubber reservoir (see “scavenger”) such that a pressure of the product gas in the scrubber reservoir (see “scavenger”) increases (paragraph 578, lines 10-15; paragraph 680, lines 22-26; note also paragraph 185, lines 1-7 which expressly teaches that a flow restriction has the purpose of raising “the upstream pressure and density”; note that the scrubber reservoir is upstream of the flow restriction as outlined in each of paragraphs 580 and 680 by the term “end”) in order to allow NO-containing gas at higher pressure to be able to flow into the vent flow at all times (paragraph 578, lines 10-15; paragraph 680, lines 22-26).
Therefore, 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 NO generation system of Zapol’s Figure 88 to further include a flow controller positioned downstream of each scrubber reservoir, the flow controller having at least one setting to allow the product gas flow entering the scrubber reservoir to be greater than the product gas flow exiting the scrubber reservoir such that a pressure of the product gas in the scrubber reservoir increases, as additionally taught by Zapol, in order to establish NO-containing gas at higher pressure, so that it can flow into the vent flow at all times.
Regarding claim 4, Zapol discloses the system of claim 1, as discussed above.
Zapol fails to explicitly disclose wherein the scrubber reservoir includes one or more pneumatic connections that are configured to be under high pressure, in the presently relied on combination.
However, Zapol additionally teaches wherein the scrubber reservoir (“scavenger”/”scavenger path”) includes one or more pneumatic connections that are configured to be under high pressure (paragraph 437, lines 20-28, see “tube”; note that “high pressure is relative, and throughout Zapol’s embodiments, pressurized air is delivered to the circuitry via pressurized air sources and pumps, and the scrubber reservoir tubing is understood to withstand such pressure).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide the scrubber reservoir of modified Zapol with one or more pneumatic connections that are configured to be under high pressure, as further taught by Zapol, as a known tube-based configuration for scrubbing the NO product gas.
Regarding claim 5, Zapol discloses the system of claim 4, as discussed above.
Modified Zapol further discloses wherein the one or more pneumatic connections are configured to be replaceable (paragraph 437, lines 22-23, where the device is disposable).
Regarding claim 6, Zapol discloses the system of claim 1, as discussed above.
Zapol further discloses wherein the scrubber reservoir (see FSFs in Fig. 88) is replaceable (note in Fig. 88, the portion containing FSFs is noted as a scavenger cartridge, and in paragraph 215, the scavenger cartridge is noted to be replaceable).
Regarding claim 7, Zapol discloses the system of claim 1, as discussed above.
Zapol further discloses a controller configured to regulate an amount of nitric oxide in the product gas using one or more parameters as an input to the controller, the one or more parameters including information from a plurality of sensors configured to collect information relating to at least one of the reactant gas, the product gas, and an inspiratory gas into which the product gas flows (paragraph 580, lines 1-18, see “feedback loop”, “controlled”, and “control algorithm”; paragraph 16, lines 1-10).
Regarding claim 8, Zapol discloses the system of claim 1, as discussed above.
As modified, Zapol discloses where the flow controller (see “flow restriction” of paragraphs 578 and 680) is comprised of a plurality of flow controllers (see “flow restriction” of paragraphs 578 and 680) (note the rejection of claim1 above, and Fig. 88, where the relied upon flow restrictors are positioned downstream of each of FSFs in Fig. 88).
Regarding claim 9, Zapol discloses the system of claim 1, as discussed above.
Zapol fails to disclose a pump configured to pump a flow of at least one or the reactant gas and product gas.
However, in a separate embodiment, Zapol further teaches a pump (400) configured to pump a flow of product gas in order to control and synchronize dispersal of the product gas to the inspiratory flow with patient breath (paragraph 225, lines 1-15; Fig. 19).
Therefore, 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 device of modified Zapol to further include a piston pump disposed downstream of the plasma chamber and upstream of the scrubber reservoir, as taught by Zapol’s Fig. 19, in order to control and synchronize dispersal of the product gas to the inspiratory flow with patient breath.
Regarding claim 10, Zapol discloses the system of claim 9, as discussed above.
Modified Zapol further discloses wherein the pump (410; Fig. 19) is positioned between the one or more plasma chambers (1110+1112 of Fig. 88) and the scrubber reservoir (FSFs of Fig. 88) such that a pressure in the one or more plasma chambers (1110+1112 of Fig. 88) and the scrubber reservoir differ (FSFs of Fig. 88) (paragraph 225, lines 1-15, note that stroke and speed of the pump can be variably controlled based on patient breath, and thus the piston is configured to pressurize the scrubber reservoir flow relative to the plasma chamber flow; Fig. 19, note Fig. 88 and the modification with respect to claim 9 for the positioning of the piston).
Regarding claim 11, Zapol discloses the system of claim 10, as discussed above.
In the relied upon combination, Zapol does not explicitly provide that a pressure within the one or more plasma chambers is near atmospheric.
However, separately, Zapol contemplates that a target pressure within the one or more plasma chambers is near atmospheric when a flow restrictor is placed downstream of the plasma chamber, in order to improve NO production efficiency by increasing air pressure within the chamber (paragraph 681, lines 7-14).
Therefore, 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 device of modified Zapol to target the pressure within the one or more plasma chambers to be near atmospheric, as additionally taught by Zapol, in order to improve NO production efficiency by increasing air pressure within the chamber.
Regarding claim 14, Zapol discloses the system of claim 1, as discussed above.
Zapol further discloses a flow sensor (see either of FS1 OR FS2 in Fig. 88) configured to measure a flow of the reactant gas into the one or more plasma chambers (1110+1112) (paragraph 580, lines 9-14 and see paragraph 7, lines 1-2 where the reactant gas source is configured to be in the form of a reservoir; Fig. 88, note that FS1 and FS2 are upstream of flow restrictors and the plasma chambers 1110 and 1112).
Regarding claim 15, Zapol discloses the system of claim 1, as discussed above.
In the presently relied on embodiment, Zapol fails to disclose a flow sensor configured to measure a flow of the product gas downstream of the one or more plasma chambers.
However, in a separate embodiment, Zapol additionally teaches a flow sensor (see “gas sensors”) configured to measure a flow of the product gas downstream of the one or more plasma chambers in order to measure various characteristics of the flow exiting the plasma chambers (paragraph 187, lines 4-6, 10-11, and 16-19).
Therefore, 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 device of modified Zapol to further include a flow sensor configured to measure a flow of the product gas downstream of the one or more plasma chambers, as taught by Zapol’s additional embodiment, in order to measure various characteristics of the flow exiting the plasma chambers.
Regarding claim 16, Zapol discloses the system of claim 1, as discussed above.
Zapol further discloses wherein the flow controller (see “flow restriction” of paragraphs 578 and 680 above, which are modified to be positioned following the FSFs in Fig. 88) is configured to be positioned to release an amount of product gas into an inspiratory flow in proportion to a measured flow rate of the inspiratory gas (paragraph 580, lines 9-12 and 21-24; Fig. 88, note that the above-identified position of the flow controllers are positioned to deliver pulses of product gas to the check valves and inspiratory limb; see also paragraph 377, lines 13-17).
Regarding claim 17, Zapol discloses the system of claim 1, as discussed above.
Zapol further discloses wherein the flow controller (see “flow restriction” of paragraphs 578 and 680 above, which are modified to be positioned following the FSFs in Fig. 88) is configured to be positioned to release one or more pulses of product gas into an inspiratory flow (paragraph 580, lines 21-24; Fig. 88, note that the above-identified position of the flow controllers are positioned to deliver pulses of product gas to the check valves and inspiratory limb).
Regarding claim 18, Zapol discloses a nitric oxide (NO) generation system (paragraph 120, lines 1-2; paragraph 580, lines 1-24; Fig. 88), comprising:
one or more plasma chambers (1110+1112) configured to ionize a reactant gas to generate a plasma for producing a product gas containing nitric oxide (NO) using a flow of the reactant gas through the one or more plasma chambers (1110+1112) (paragraph 580, lines 15-21; note paragraph 5, lines 6-14, paragraph 184, lines 4-6 for explanation of plasma generation in plasma chambers, ad paragraph 336, lines 1-4; Fig. 88);
a reservoir (see one of FSFs in Fig. 88) downstream of the one or more plasma chambers (1110+1112), the reservoir (see either one of FSFs in Fig. 88) configured to store the product gas therein (paragraph 580, lines 18-21; Fig. 88; see also paragraph 19, lines 4-6 for explanation of NO2 removal in a scavenger cartridge from generated nitric oxide; note that the product gas is at least stored in the FSF while it travels therethrough).
While Zapol indicates the presence of check valves downstream of the reservoir (see one of FSFs in Fig. 88) (paragraph 580, lines 21-24; Fig. 88), in this embodiment Zapol fails to explicitly disclose a flow controller positioned downstream of the reservoir, the flow controller having at least one setting to allow the product gas flow entering the reservoir to be greater than the product gas flow exiting the reservoir such that a pressure of the product gas in the reservoir increases.
However, Zapol separately teaches that in certain embodiments, a flow controller (see “flow restriction”) can be positioned downstream of the reservoir (see “scavenger”) (paragraph 578, lines 10-15; paragraph 680, lines 22-26; note also paragraph 185, lines 1-7 which expressly teaches that a flow restriction has the purpose of raising “the upstream pressure and density”), the flow controller (see “flow restriction”) having at least one setting to allow the product gas flow entering the reservoir (see “scavenger”) to be greater than the product gas flow exiting the reservoir (see “scavenger”) such that a pressure of the product gas in the reservoir (see “scavenger”) increases (paragraph 578, lines 10-15; paragraph 680, lines 22-26; note also paragraph 185, lines 1-7 which expressly teaches that a flow restriction has the purpose of raising “the upstream pressure and density”; note that the reservoir is upstream of the flow restriction as outlined in each of paragraphs 580 and 680 by the term “end”) in order to allow NO-containing gas at higher pressure to be able to flow into the vent flow at all times (paragraph 578, lines 10-15; paragraph 680, lines 22-26).
Therefore, 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 NO generation system of Zapol’s Figure 88 to further include a flow controller positioned downstream of the reservoir, the flow controller having at least one setting to allow the product gas flow entering the reservoir to be greater than the product gas flow exiting the reservoir such that a pressure of the product gas in the reservoir increases, as additionally taught by Zapol, in order to establish NO-containing gas at higher pressure, so that it can flow into the vent flow at all times.
Regarding claim 19, Zapol discloses the system of claim 18, as discussed above.
Zapol further discloses wherein the reservoir (see one of FSFs in Fig. 88) includes scrubber material to remove NO2 from the product gas during storage of the product gas (paragraph 580, lines 18-21; Fig. 88; see also paragraph 19, lines 4-11 for explanation of NO2 removal in a scavenger cartridge from generated nitric oxide).
Regarding claim 22, Zapol discloses the system of claim 18, as discussed above.
Zapol fails to disclose a pump configured to pump a flow of at least one or the reactant gas and product gas.
However, in a separate embodiment, Zapol further teaches a pump (400) configured to pump a flow of product gas in order to control and synchronize dispersal of the product gas to the inspiratory flow with patient breath (paragraph 225, lines 1-15; Fig. 19).
Therefore, 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 device of modified Zapol to further include a piston pump disposed downstream of the plasma chamber and upstream of the reservoir, as taught by Zapol’s Fig. 19, in order to control and synchronize dispersal of the product gas to the inspiratory flow with patient breath.
Regarding claim 23, Zapol discloses the system of claim 18, as discussed above.
Zapol further discloses a controller configured to regulate an amount of nitric oxide in the product gas using one or more parameters as an input to the controller, the one or more parameters including information from a plurality of sensors configured to collect information relating to at least one of the reactant gas, the product gas, and an inspiratory gas into which the product gas flows (paragraph 580, lines 1-18, see “feedback loop”, “controlled”, and “control algorithm”; paragraph 16, lines 1-10).
Regarding claim 24, Zapol discloses a method of generating nitric oxide (NO) (paragraph 5, lines 6-14; paragraph 120, lines 1-2; paragraph 580, lines 1-24; Fig. 88), comprising:
ionizing a reactant gas inside one or more plasma chambers (1110+1112) to generate a plasma for producing a product gas containing nitric oxide using a flow of the reactant gas through the one or more plasma chambers (1110+1112) (paragraph 580, lines 15-21; note paragraph 5, lines 6-14, paragraph 184, lines 4-6 for explanation of plasma generation in plasma chambers, ad paragraph 336, lines 1-4; Fig. 88);
storing the product gas in a reservoir (see one of FSFs in Fig. 88) downstream of the one or more plasma chambers (1110+1112) (paragraph 580, lines 18-21; Fig. 88; see also paragraph 19, lines 4-6 for explanation of NO2 removal in a scavenger cartridge from generated nitric oxide; note that the product gas is at least stored in the FSF while it travels therethrough).
While Zapol indicates the presence of check valves downstream of the reservoir (see one of FSFs in Fig. 88) (paragraph 580, lines 21-24; Fig. 88), in this embodiment Zapol fails to explicitly disclose providing a flow of pressurized product gas from the reservoir to a flow controller downstream of the reservoir, the flow controller controlling the flow of product gas flow from the reservoir to an inspiratory gas flow.
However, Zapol separately teaches that in certain embodiments, it is possible to provide a flow of pressurized product gas from the reservoir (see “scavenger”) to a flow controller (see “flow restriction”) downstream of the reservoir (see “scavenger”), the flow controller (see “flow restriction”) controlling the flow of product gas flow from the reservoir (see “scavenger”) to an inspiratory gas flow (paragraph 578, lines 10-15; paragraph 680, lines 22-26; note also paragraph 185, lines 1-7 which expressly teaches that a flow restriction has the purpose of raising “the upstream pressure and density”, and thus the flow restriction is understood to pressurize the upstream flow; note that the reservoir is upstream of the flow restriction as outlined in each of paragraphs 580 and 680 by the term “end”) in order to allow NO-containing gas at higher pressure to be able to flow into the vent flow at all times (paragraph 578, lines 10-15; paragraph 680, lines 22-26).
Therefore, 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 NO generation method of Zapol’s Figure 88 to further include providing a flow of pressurized product gas from the reservoir to a flow controller downstream of the reservoir, the flow controller controlling the flow of product gas flow from the reservoir to an inspiratory gas flow, as additionally taught by Zapol, in order to establish NO-containing gas at higher pressure, so that it can flow into the vent flow at all times.
Regarding claim 25, Zapol discloses the method of claim 24, as discussed above.
Zapol further discloses wherein the reservoir (see one of FSFs in Fig. 88) includes a scrubbing material that removes NO2 from the product gas (paragraph 580, lines 18-21; Fig. 88; see also paragraph 19, lines 4-11 for explanation of NO2 removal in a scavenger cartridge from generated nitric oxide).
Regarding claim 26, Zapol discloses the method of claim 24, as discussed above.
Zapol further discloses controlling an amount of nitric oxide in the product gas using one or more parameters as input to a control algorithm used by one or more controllers to control the one or more plasma chambers (1110+1112), at least one of the one or more parameters being related to a target concentration of NO in a combination of the product gas and an inspiratory gas into which the product gas flows (paragraph 580, lines 1-18, see “feedback loop”, “controlled”, and “control algorithm”; paragraph 16, lines 1-10).
Claims 2-3 and 20-21 are rejected under 35 U.S.C. 103 as being unpatentable over Zapol (US 2018/0243527), as applied to claims 1 and 18 above, in view of Acker (US 2015/0320953).
Regarding claim 2, Zapol discloses the system of claim 1, as discussed above.
Zapol fails to explicitly disclose wherein a dead volume of gas between the scrubber reservoir and the flow controller is minimized.
However, Acker teaches gas coupling within a therapy gas delivery system (paragraph 127, lines 21-26 and 38-45; abstract, lines 1-3), wherein a dead volume of gas between components is minimized in order to avoid the difficulty of purging NO2 from the connections and avoid causing NO2 to be generated (paragraph 127, lines 21-26 and 38-45).
Therefore, 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 connection between the scrubber reservoir and the flow controller of Zapol such that a dead volume between them were minimized, as taught by Acker, in order to avoid the difficulty of purging NO2 from the connections and avoid causing NO2 to be generated.
Regarding claim 3, Zapol in view of Acker disclose the system of claim 1, as discussed above.
Zapol further discloses wherein a pressurized product gas delivery tube introduces the product gas to an inspiratory flow (paragraph 580; Fig. 88, see inspiratory limb following the check valves; paragraph 449, lines 1-14, note that the “pneumatic routing” is cited to route product gas to a ventilator, or route gas to a ventilator cartridge; paragraph 450, lines 1-3, where when multiple manifolds are used, the pneumatic pathways are handled in different manifolds).
Zapol fails to explicitly disclose wherein the tube provides minimal dead volume to an introduction of an inspiratory flow.
However, Acker teaches gas coupling within a therapy gas delivery system (paragraph 127, lines 21-26 and 38-45; abstract, lines 1-3), wherein a dead volume of gas between components is minimized in order to avoid the difficulty of purging NO2 from the connections and avoid causing NO2 to be generated (paragraph 127, lines 21-26 and 38-45).
Therefore, 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 connection between the tube and the inspiratory limb of Zapol such that a dead volume between them were minimized, as taught by Acker, in order to avoid the difficulty of purging NO2 from the connections and avoid causing NO2 to be generated.
Regarding claim 20, Zapol discloses the system of claim 18, as discussed above.
Zapol fails to explicitly disclose wherein a dead volume of gas between the reservoir and the flow controller is minimized.
However, Acker teaches gas coupling within a therapy gas delivery system (paragraph 127, lines 21-26 and 38-45; abstract, lines 1-3), wherein a dead volume of gas between components is minimized in order to avoid the difficulty of purging NO2 from the connections and avoid causing NO2 to be generated (paragraph 127, lines 21-26 and 38-45).
Therefore, 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 connection between the reservoir and the flow controller of Zapol such that a dead volume between them were minimized, as taught by Acker, in order to avoid the difficulty of purging NO2 from the connections and avoid causing NO2 to be generated.
Regarding claim 21, Zapol in view of Acker disclose the system of claim 20, as discussed above.
Zapol further discloses wherein a pressurized product gas delivery tube introduces the product gas to an inspiratory flow (paragraph 580; Fig. 88, see inspiratory limb following the check valves; paragraph 449, lines 1-14, note that the “pneumatic routing” is cited to route product gas to a ventilator, or route gas to a ventilator cartridge; paragraph 450, lines 1-3, where when multiple manifolds are used, the pneumatic pathways are handled in different manifolds).
Zapol fails to explicitly disclose wherein the tube provides minimal dead volume to an introduction of an inspiratory flow.
However, Acker teaches gas coupling within a therapy gas delivery system (paragraph 127, lines 21-26 and 38-45; abstract, lines 1-3), wherein a dead volume of gas between components is minimized in order to avoid the difficulty of purging NO2 from the connections and avoid causing NO2 to be generated (paragraph 127, lines 21-26 and 38-45).
Therefore, 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 connection between the tube and the inspiratory limb of Zapol such that a dead volume between them were minimized, as taught by Acker, in order to avoid the difficulty of purging NO2 from the connections and avoid causing NO2 to be generated.
Claims 12-13 are rejected under 35 U.S.C. 103 as being unpatentable over Zapol (US 2018/0243527), as applied to claim 1 above, in view of Zapol (US 2016/0038710), hereinafter referred to as Zapol ‘710.
Regarding claim 12, Zapol discloses the system of claim 1, as discussed above.
Zapol, as presently modified, fails to disclose wherein the flow of reactant gas through the one or more plasma chambers is a constant value.
However, Zapol ‘710 teaches wherein the flow of reactant gas through the one or more plasma chambers is a constant value (paragraph 118; paragraph 170, lines 1-5; Figs. 2A and 35).
Therefore, 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 a constant flow rate of reactant gas through the Zapol plasma chambers, as taught by Zapol ‘710, as a known value of reactant gas flow rate provided to a plasma chamber for creating product gas.
Regarding claim 13, Zapol in view of Zapol ‘710 disclose the system of claim 12, as discussed above.
As presently modified, Zapol fails to disclose wherein the flow of product gas into the scrubber reservoir is a constant value.
However, in a separate embodiment, Zapol further teaches a pump (400/460) configured to pump a flow of product gas in order to control and synchronize dispersal of the product gas to the inspiratory flow with patient breath (paragraph 225, lines 1-15; Figs. 19 and 25), wherein the flow of product gas into the scrubber reservoir is a constant value (paragraph 225, final 5 lines)
Therefore, 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 device of modified Zapol to further include a piston pump disposed downstream of the plasma chamber and upstream of the scrubber reservoir and to provide gas flow out of the pump to the scrubber reservoir at a constant flow rate, as taught by Zapol’s Fig. 19, in order to control and synchronize dispersal of the product gas to the inspiratory flow with patient breath.
Conclusion
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/PAIGE KATHLEEN BUGG/Primary Examiner, Art Unit 3785
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