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 preliminary amendment filed on 12/23/2025. As directed by the amendment, no claims were canceled, claims 1-4, 6, 8-10, 12, 14-15, and 17 were amended, and no claims were newly added. Thus, claims 1-20 are presently pending in this application.
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.
Claims 10-20 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 10 line 1, the term “anesthetic gas” is unclear as to if the term is the same or different than “anesthetic gas” of claim 8 line 2.
Any remaining claims are rejected as being dependent upon a rejected base claim.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-2, 4, and 8-12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kuzelka et al. (US 2021/0008327; hereinafter “Kuzelka”).
Regarding claim 1, Kuzelka discloses a system for a vaporizer gas mixer (anesthetic vaporizer cartridge 200 installed in anesthesia machine 201) comprising:
a one-piece body (anesthetic vaporizer cartridge 200);
a gas inlet passage (input 284) and a gas outlet passage (output 286);
a first flow path fluidically coupled to the gas inlet passage and the gas outlet passage (flow path through gas inlet passage 236 and gas outlet passage 238 and pressure equalization tube 237), the first flow path having a plurality of curves (Fig. 2A-B show passages 238, 238 contain a plurality of curves, and single curve of pressure equalization tube 237);
wherein the first flow path comprises a first mixing passage that only provides in-plane mixing with respect to the gas inlet passage and the gas outlet passage (see Kuzelka gas mixing in outlet passage 238; has an S-curve in plane with inlet, outlet 284, 286, see annotated Fig. 2A below “in-plane-plane”) and a second mixing passage that only provides out-of-plane mixing with respect to the gas inlet passage and the gas outlet passage (see Kuzelka gas mixing in pressure equalization tube 237 has vertical portion perpendicular to the gas inlet, outlet in the “out-of-plane-plane” in annotated Fig. 2A below); and
a second flow path fluidically coupled to the first flow path and a vaporizing chamber (vapor delivery passage 240 in Fig. 2B into pressure equalization tube 237 in Fig. 2A),
wherein the first flow path and the second flow path merge after the gas inlet passage and before the plurality of curves (Fig. 2A flow from input 284, vapor flows up from passage 240, through pressure equalization tube 237 into line before curves in outlet passage 238).
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Kuzelka Annotated Fig. 2A
Regarding claim 2, Kuzelka discloses wherein the first mixing passage comprises an s-curve in-plane with respect to the gas inlet passage and the gas outlet passage (see Kuzelka Fig. 2A gas outlet passage 238 has an S-curve in plane with inlet, outlet 284, 286).
Regarding claim 4, Kuzelka discloses the second mixing passage comprises a curve out-of-plane with respect to the gas inlet passage and the gas outlet passage (see Kuzelka Fig. 2A pressure equalization tube 237 curves out of plane with respect to inlet, outlet 284, 286).
Regarding claim 8, Kuzelka discloses a system (anesthetic vaporizer cartridge 200 installed in anesthesia machine 201), comprising:
an anesthetic source of anesthetic gas (liquid anesthetic agent 210 in sump 222);
a vaporizer gas mixer (sump 222) having a one-piece plastic body (housing 204; [0034] comprised of plastics, with connection to quick disconnect pneumatic system 282) coupled with the anesthetic source (liquid anesthetic agent 210 in sump 222), the one-piece plastic body having a gas inlet passage (input 284) and a gas outlet passage (output 286) in a first plane with a flow path therebetween (flow path through gas inlet passage 236 and gas outlet passage 238, with merging flow from vapor delivery passage 240 in Fig. 2B into pressure equalization tube 237 in Fig. 2A), wherein the flow path comprises a first mixing passage curving only in the first plane (Fig. 2A-B show passages 238, 238 contain a plurality of curves; see annotated Fig. 2A above) and a second mixing passage curving only out of the first plane (Fig. 2A pressure equalization tube 237 curves out of plane before merging into plane with passages 236, 238; see annotated Fig. 2A above).
Regarding claim 9, Kuzelka discloses the one-piece plastic body further coupled with a source of medical gas ([0037] “Input 284 is configured to connect to a fresh gas flow of anesthesia machine 201 and, when connected, enables fresh gas (e.g., oxygen, air, nitrous oxide, and combinations thereof) to flow from anesthesia machine 201 to anesthetic vaporizer cartridge 200 via a gas inlet passage 236”).
Regarding claim 10, Kuzelka discloses anesthetic gas from the anesthetic source enters the flow path through an opening in an internal wall of the flow path (Fig. 2B top opening of manifold 254 into passage 240), the opening positioned in the flow path before the first mixing passage and the second mixing passage (Fig. 2B manifold 254 is before passages 236, 238, 240 and pressure equalization tube 237).
Regarding claim 11, Kuzelka discloses gas flows from the source of medical gas enter the vaporizer gas mixer through the gas inlet passage ([0037] input 284 connects to fresh gas flow into anesthetic vaporizer cartridge 200) and combines flow with the anesthetic source of anesthetic gas at and downstream from the opening (gas is mixed when vaporized anesthetic flows up through passage 240 and pressure equalization tube 237 into passages 236, 238 before the outlet 286), the combined flow exiting the vaporizer gas mixer through the gas outlet passage ([0037] output 286 connects to the mixed gas flow of anesthesia machine 201 to flow out).
Regarding claim 12, Kuzelka discloses curves of the first mixing passage and the second mixing passage are in a central region of the one-piece plastic body (Fig. 2A curves are in the middle of the anesthetic vaporizer cartridge 200 in passages 236, 238, etc).
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.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Kuzelka as applied to claim 2 above, and further in view of Kuzelka.
Regarding claim 3, Kuzelka discloses the first mixing passage comprises an s-curve in-plane with respect to the gas inlet passage and the gas outlet passage, except for at least two s-curves in plane. It would have been an obvious matter of design choice to modify the first mixing passage of Kuzelka from the shape of a single s-curve to the shape of at least two s-curves, since such a modification would have involved a mere change in the form or shape of a component. A change in form or shape is generally recognized as being within the level of ordinary skill in the art. In re Dailey, 149 USPQ 47 (CCPA 1976).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Kuzelka as applied to claim 1 above, and further in view of Falb et al. (US 5,243,973; hereinafter “Falb”).
Regarding claim 5, Kuzelka is silent as to gas flows from the vaporizing chamber into the second flow path is actuated by a valve. However, Falb teaches gas flows from the vaporizing chamber (see Falb container 6 with anesthetic 2 heated by coil 11) into the second flow path (see Falb outlet line 10) is actuated by a valve (see Falb float valve 16). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the connection between the vaporizing chamber and second flow path of Kuzelka with the addition of an actuatable valve as taught by Falb so as to provide an extra measure of safety to the patient.
Claims 6-7 are rejected under 35 U.S.C. 103 as being unpatentable over Kuzelka as applied to claim 1 above, and further in view of Albarda (US 4,477,395).
Regarding claim 6, Kuzelka is silent as to one or more sensors are positioned in the gas inlet passage to sense gas flows in the first flow path before being combined with gas flows from the second flow path. However, Albarda teaches one or more sensors are positioned in the gas inlet passage to sense gas flows in the first flow path before being combined with gas flows from the second flow path (see Albarda inlet temperature sensor 6 in inlet 3). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the gas inlet passage of Kuzelka with the addition of a sensor to measure gas flow in the first flow path as taught by Albarda so as to have an initial sensor reading of the gas flow before mixing with the anesthetic to ensure patient safety and dosage accuracy in some regard.
Regarding claim 7, modified Kuzelka is silent as to one or more point sensors are positioned in the gas outlet passage to sense gas flows in the first flow path after being combined with gas flows in the second flow path. However, Albarda teaches one or more point sensors are positioned in the gas outlet passage to sense gas flows in the first flow path after being combined with gas flows in the second flow path (see Albarda outlet temperature sensor 7 in outlet 4 able to measure thermal conductivity of gas mixture [see present invention specification [0049]], outlet would be past any flow path). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the gas outlet passage of modified Kuzelka with the addition of a point sensor to measure gas flow after mixing with the anesthetic as taught by Albarda so as to ensure patient safety and dosage accuracy of anesthetic.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Kuzelka as applied to claim 12 above, and further in view of Pernikoff et al. (US 2015/0209546; hereinafter “Pernikoff”).
Regarding claim 13, Kuzelka discloses the vaporizer gas mixer having a first sensor (see Kuzelka first temperature sensor 228) and a second sensor (see Kuzelka second temperature sensor 252), but is silent as to a plurality of through-holes for at least a first sensor and at least a second sensor. However, Pernikoff teaches a plurality of through-holes for at least a first sensor and at least a second sensor (see Pernikoff Fig. 2 thru hole 7 for acoustic sensor L1; thru hole 9 for temperature sensor T1; etc.). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the location of the sensors of Kuzelka with the location of a through hole for the sensors as taught by Pernikoff so as to provide more protection to the sensors to maintain their calibration.
Claims 14-20 are rejected under 35 U.S.C. 103 as being unpatentable over Kuzelka in view of Pernikoff as applied to claim 13 above, and further in view of Albarda (US 4,477,395).
Regarding claim 14, modified Kuzelka discloses the first sensor is positioned in the gas inlet passage before medical gas combines with anesthetic gas and the second sensor is positioned in the gas outlet passage after the first mixing passage and the second mixing passage of the flow path. However, Albarda teaches the first sensor is positioned in the gas inlet passage before medical gas combines with anesthetic gas (see Albarda inlet temperature sensor 6 in inlet 3) and the second sensor is positioned in the gas outlet passage after the first mixing passage and the second mixing passage of the flow path (see Albarda outlet temperature sensor 7 in outlet 4, outlet would be past any flow path). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the location of the sensors of modified Kuzelka with the placement of the sensors in the inlet and outlet passages as taught by Albarda so as to measure the sensor data from the beginning and ending of the flow cycle (at the inlet and outlet) to ensure proper gas mixing is being delivered to the patient.
Regarding claim 15, modified Kuzelka discloses the second mixing passage comprises a U-shaped bend out-of-plane of the one-piece plastic body (see Kuzelka Fig. 2A pressure equalization tube 237 curves out of plane as a U-shaped bent protrusion out of housing 204).
Regarding claim 16, modified Kuzelka discloses the gas flows between the anesthetic source of anesthetic gas and the one-piece plastic body are controlled by an actuator (see Kuzelka [0030] valve position of the anesthesia machine may be controlled via controller that transits an electrical signal to an actuator in order to adjust valves to output positions).
Regarding claim 17, modified Kuzelka discloses the flow path comprises a plurality of s-curves (see Kuzelka inlet passage 236 and outlet passage 238), the first mixing passage having at least two s-curves in-plane (see Kuzelka one s-curve in each of the inlet and outlet passages 236, 238 makes two s-curves in plane) and the second mixing passage having at least one curve out-of-plane (see Kuzelka Fig. 2A pressure equalization tube 237 curves out of plane before merging into plane with passages 236, 238). Modified Kuzelka is silent as to at least one s-curve shape out-of-plane. It would have been an obvious matter of design choice to modify the at least one curve out-of-plane of modified Kuzelka with the s-curve shape, since such a modification would have involved a mere change in the form or shape of a component. A change in form or shape is generally recognized as being within the level of ordinary skill in the art. In re Dailey, 149 USPQ 47 (CCPA 1976).
Regarding claim 18, modified Kuzelka discloses the flow path from the gas inlet passage to the gas outlet passage comprises a smooth internal wall (see Kuzelka passages 236, 238 are smooth tubes, no baffles or other protrusions are shown that would make a non-smooth passage 236, 238).
Regarding claim 19, modified Kuzelka discloses the flow path narrows after the opening in the internal wall of the flow path and before the plurality of s-curves (see Kuzelka Fig. 2B venturi 260 occurs after manifold 254, which is before passages 236, 238, 240 and pressure equalization channel 237).
Regarding claim 20, modified Kuzelka discloses a controller (see Kuzelka controller 225) storing executable instructions in non-transitory memory (see Kuzelka [0042] controller 225 responds to non-volatile memory (e.g., EEPROM, a microcontroller, etc.)) that, when executed cause the controller to:
receive signals from the first sensor and the second sensor (see Kuzelka [0048] sensors 228, 252 transfers signals to controller 225);
Modified Kuzelka is silent as to compare a signal difference of the first sensor and the second sensor to a threshold signal difference; and,
responsive to identifying signal difference greater than a threshold difference, adjust the actuator controlling the flow of anesthetic gas between the anesthetic source and the one-piece plastic body.
However, Albarda teaches compare a signal difference of the first sensor and the second sensor to a threshold signal difference (see Albarda Col. 3 lines 58-61 “The temperature sensors 6, 7 are resistance sensors and form part of a bridge circuit 17 whose output (difference) signal is sent via an amplifier 18”); and,
responsive to identifying signal difference greater than a threshold difference (see Albarda Col. 4 lines 3-5, 13-18 “control and evaluating circuit 19 has a set point corresponding to a nominal value for the anesthetic flow”; and heating system 8 is controlled by the difference of sensors 6, 7), adjust the actuator controlling the flow of anesthetic gas between the anesthetic source and the one-piece plastic body (see Albarda Col. 3 lines 62-68 difference signal controls evaluating circuit 19 to control heating element 8, where the temperature level would vaporize more or less anesthetic). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the controller of modified Kuzelka with the controller and sensor information processing as taught by Albarda so as to precisely control the rate of vaporization using the sensor information.
Response to Arguments
Applicant's arguments filed 12/23/2025 have been fully considered but they are not persuasive.
Applicant argues, on page 9 of the remarks, that “Applicant can find no disclosure in Kuzelka of a first flow path that comprises "a first mixing passage that only provides in-plane mixing with respect to the gas inlet passage and the gas outlet passage and a second mixing passage that only provides out-of-plane mixing with respect to the gas inlet passage and the gas outlet passage," as specified in Applicant's amended claim 1” and nearly equivalent language from amended claim 8 on pages 9-10 of the remarks. However, Examiner disagrees. Prior art Kuzelka does appear to have the necessary features, and annotated Fig. 2A was added above to further emphasize the Examiner’s position. Therefore, the rejection still stands.
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 GWYNNETH L HOWELL whose telephone number is (703)756-4742. The examiner can normally be reached 8:30-4:30 M-F.
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/GWYNNETH L HOWELL/Examiner, Art Unit 3785
/RACHEL T SIPPEL/Primary Examiner, Art Unit 3785