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 .
Claim Objections
Claim(s) 13 is/are objected to because of the following informalities:
Claim 13, Ln. 2 recites “a flow rate of the ventilator drive gas” which should read “the flow rate of the ventilator drive gas” following after claim 8
Appropriate correction is required.
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 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1, 4-9 and 15-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wallen (U.S. Pub. 2012/0125329).
Regarding claim 1, Wallen discloses a method for an anesthesia system (Fig. 2; ¶0043), comprising: flowing ventilator drive gas (Fig. 2 along #51; ¶0055) through a bellowless plenum (Fig. 2 #26; ¶0051 – fixed volume) separating a ventilator drive gas circuit (Fig. 2 upstream of #26) from an inspiratory gas circuit (Fig. 2 downstream of #26); and providing the ventilator drive gas flowing through the bellowless plenum to an inspiratory port (Fig. 2 #15 or connection of #6 to #4; various “ports” in Wallen are readable as the inspiratory port) of the inspiratory gas circuit. The term “bellowless” is understood that the volume of the plenum can in no way be defined by a bellows type of structure. It is noted that while the claim is recited as “for an anesthesia system” there are not found to be any recitations in the claim which specifically define the system as for use with anesthesia, as opposed to merely being a generic ventilator system. It is noted that the embodiment of Fig. 3 in Wallen can be similarly read on the instant claim.
Regarding claim 4, Wallen discloses providing the ventilator drive gas flowing through the bellowless plenum to the inspiratory port of the inspiratory gas circuit includes: mixing the ventilator drive gas with mixer gas (Fig. 2 from #21 delivered to #19; ¶0047) from a mixer gas source (Fig. 2 #21; ¶0047) to form an inspiratory gas mixture (gas mixture at Fig. 2 #19); and delivering the inspiratory gas mixture to the inspiratory port (Fig. 2 connection of #6 to #4). It is noted that the inspiratory port is not required to be an upstream port of the inspiratory gas circuit.
Regarding claim 5, Wallen discloses combining the ventilator drive gas with the mixer gas occurs downstream of the bellowless plenum along a flow path from the bellowless plenum to the inspiratory port (Fig. 2).
Regarding claim 6, Wallen discloses adjusting a gas ratio of the inspiratory gas mixture, where the gas ratio is a ratio of the ventilator drive gas to the mixer gas (¶¶0102, 0105, 0108).
Regarding claim 7, Wallen discloses adjusting an amount of the mixer gas within the inspiratory gas mixture based on a composition of the ventilator drive gas (¶¶0102, 0108).
Regarding claim 8, Wallen discloses a method for an anesthesia system (Fig. 2; ¶0043), comprising: flowing ventilator drive gas (Fig. 2 along #51; ¶0055) from a ventilator drive gas source (Fig. 2 #53 or #20D and/or #20E; ¶¶0064-0065) to a patient inspiratory port (Fig. 2 #2; ¶0093) via a bellowless plenum (Fig. 2 #26; ¶0051 – fixed volume) separating the ventilator drive gas source from a mixer gas source (Fig. 2 #21; ¶0047); and adjusting a flow rate of the ventilator drive gas based on the mixer gas source (¶0056 – gas flow ratio adjusted between lines 18 and 14). The term “bellowless” is understood that the volume of the plenum can in no way be defined by a bellows type of structure. It is noted that while the claim is recited as “for an anesthesia system” there are not found to be any recitations in the claim which specifically define the system as for use with anesthesia, as opposed to merely being a generic ventilator system.
Regarding claim 9, Wallen discloses forming a mixture (gas mixture at Fig. 2 #19) of the ventilator drive gas and a mixer gas (Fig. 2 from #21 delivered to #19; ¶0047) from the mixer gas source downstream of the bellowless plenum and upstream of the patient inspiratory port.
Regarding claim 15, Wallen discloses after flowing the ventilator drive gas from the ventilator drive gas source to the patient inspiratory port via the bellowless plenum, controlling a ventilator drive gas selector to flow a second ventilator drive gas from a second ventilator drive gas source (Fig. 2 other of #20D or #20E not read as the ventilator drive gas source in claim 8; e.g. ¶0102) to the patient inspiratory port via the bellowless plenum. The claim does not exclude the possibility of the ventilator drive gas and the second ventilator drive gas being provided together.
Regarding claim 16, Wallen discloses while flowing the ventilator drive gas to the patient inspiratory port via the bellowless plenum, maintaining an exhalation valve (Fig. 2 #40; ¶0059 – opens only during expiration) arranged between the ventilator drive gas source and the bellowless plenum in a closed position.
Regarding claim 17, Wallen discloses an anesthesia system (Fig. 2; ¶0043), comprising: a ventilator drive gas source (Fig. 2 #53 or #20D and/or #20E; ¶¶0064-0065); a patient inspiratory port (Fig. 2 #2; ¶0093); a bellowless plenum (Fig. 2 #26; ¶0051 – fixed volume) separating the ventilator drive gas source from the patient inspiratory port and including a first port (Fig. 2 upstream end of #26) fluidly coupled to the ventilator drive gas source and a second port (Fig. 2 downstream end of #26) fluidly coupled to the patient inspiratory port; and an electronic controller (Fig. 2 #56; ¶¶0058-0061) including instructions stored in non-transitory memory that when executed, cause the electronic controller to: flow a ventilator drive gas from the ventilator drive gas source through the bellowless plenum to the patient inspiratory port (standard operation of Fig. 2). The term “bellowless” is understood that the volume of the plenum can in no way be defined by a bellows type of structure. It is noted that while the claim is recited as an “anesthesia system” there are not found to be any recitations in the claim which specifically define the system as for use with anesthesia, as opposed to merely being a generic ventilator system. It is noted that the embodiment of Fig. 3 in Wallen can be similarly read on the instant claim.
Regarding claim 18, Wallen discloses while flowing the ventilator drive gas from the ventilator drive gas source through the bellowless plenum to the patient inspiratory port, an entire amount of ventilator drive gas output by the ventilator drive gas source flows through the bellowless plenum to the patient inspiratory port (Fig. 2 reading the ventilator drive gas source as #20D and/or #20E).
Regarding claim 19, Wallen discloses instructions stored in the non- transitory memory that when executed, cause the electronic controller to: adjust a flow rate of the ventilator drive gas (¶0056 – gas flow ratio adjusted between lines 18 and 14) based on a mixer gas source (Fig. 2 #21; ¶0047) fluidly coupled to the patient inspiratory port via an inspiratory gas circuit (Fig. 2 downstream of #19).
Regarding claim 20, Wallen discloses a ventilator drive gas selector; and instructions stored in the non-transitory memory of the electronic controller than when executed, cause the electronic controller to: control the ventilator drive gas selector to selectably fluidly couple a second ventilator drive gas source (Fig. 2 other of #20D or #20E not read as the ventilator drive gas source in claim 17; e.g. ¶0102) to the patient inspiratory port via the bellowless plenum.
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 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 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.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) 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 nonobviousness.
Claim(s) 2-3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wallen (U.S. Pub. 2012/0125329) in view of Burgess et al. (U.S. Pub. 2024/0261523).
Regarding claim 2, Wallen fails to disclose flowing the ventilator drive gas through the bellowless plenum to a nasal cannula.
Burgess teaches a respiratory system which can deliver anesthesia (Fig. 28; ¶0384) and which can selectively either deliver anesthetic gases through an endotracheal tube (Fig. 38 #120; ¶0393) or deliver non-anesthetic gases through a nasal cannula (Fig. 38 #220; ¶0399). Burgess teaches the option to deliver from a flow source to either of two forms of patient interface as providing the benefit of creating a modular system which can perform in both a first mode which delivers anesthetic gases and a second mode which delivers high flow therapy (¶¶0392-0396).
It would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the invention to have incorporated in Wallen flowing the ventilator drive gas through the bellowless plenum to a nasal cannula in order to provide the benefit of creating a modular system which can perform in both a first mode which delivers anesthetic gases and a second mode which delivers high flow therapy in view of Burgess.
Regarding claim 3, Wallen teaches the invention as modified above and Burgess as incorporated therein further teaches flowing the ventilator drive gas provided to the inspiratory port through a multi-outlet gas diverter (Fig. 38 #1020; ¶0391) arranged upstream of the nasal cannula.
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wallen (U.S. Pub. 2012/0125329) in view of Rice et al. (U.S. Pub. 2007/0265877).
Regarding claim 10, Wallen fails to disclose flowing the mixture of the ventilator drive gas and the mixer gas to a nasal cannula coupled to the patient inspiratory port.
Rice teaches an anesthesia deliver system (Fig. 1 #12; ¶0017) which can deliver an anesthetic gas mixture to a patient via different forms of patient connection, to include an endotracheal tube or a nasal cannula (¶0017). Rice thus teaches a nasal cannula as an obvious design choice alternative to an endotracheal tube when desiring to deliver an anesthetic gas mixture to a patient.
It would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the invention to have incorporated in Wallen flowing the mixture of the ventilator drive gas and the mixer gas to a nasal cannula coupled to the patient inspiratory port based upon an obvious design choice in the art to substitute a nasal cannula for an endotracheal tube when desiring to deliver an anesthetic gas mixture to a patient in view of Rice.
Claim(s) 11-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wallen (U.S. Pub. 2012/0125329).
Regarding claim 11, Wallen discloses adjusting the mixture of the ventilator drive gas and the mixer gas (¶¶0102, 0108); and a user interface device (Fig. 2 #58; ¶0058).
Wallen is silent as to whether the adjusting is based on a selection input via the user interface device.
One of ordinary skill in the art would obviously have expected the user input/output interface of Wallen to be usable for allow a user to select a desired gas mixture. Further, Wallen teaches that various gas mixtures may be provided to the system (¶¶0102, 0108). The implementation of using the user input/output interface already taught by Wallen to provide user selection of a desired gas mixture would have thus been an obvious explaining how the different gas mixtures already contemplated by Wallen are brought into actual practice.
It would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the invention to have specified in Wallen the adjusting is based on a selection input via the user interface device based upon an obvious expectation of using the user input/output interface already taught by Wallen to provide user selection of a desired gas mixture to specify how the different gas mixtures already contemplated by Wallen are brought into actual practice.
Regarding claim 12, Wallen teaches the invention as modified above and further suggests as obvious adjusting the mixture of the ventilator drive gas and the mixer gas based on the selection input via the user interface device includes adjusting a ratio of the ventilator drive gas to the mixer gas (¶¶0102, 0105, 0108).
Regarding claim 13, Wallen teaches the invention as modified above and further suggests as obvious adjusting the ratio of the ventilator drive gas to the mixer gas includes adjusting the flow rate of the ventilator drive gas or a flow rate of the mixer gas (¶0056 – gas flow ratio adjusted between lines 18 and 14).
Regarding claim 14, Wallen fails to explicitly disclose adjusting the flow rate of the ventilator drive gas based on the mixer gas source includes setting the flow rate of the ventilator drive gas according to a composition of a mixer gas of the mixer gas source.
However, Wallen teaches using gas analyzer 23 to measure gas concentrations for feedback control of the anesthetic agent concentration being delivered to the patient (¶0081). Wallen also teaches sensor unit 640 as upstream of the fresh gas (i.e. the claimed “mixer gas”) introduction (Figs. 2-3) and teaches sensor unit 640 as able to measure gas concentration (¶0078). One of ordinary skill in the art would thus have expected the feedback control of the gas mixture delivered to the patient, which accounts for both the measurements of gas analyzer 23 and sensor unit 640, to be suitable to make adjustments to the flow from both the claimed ventilator drive gas source and the claimed mixer gas source in order to successfully deliver the desired anesthetic gas concentration to the patient.
It would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the invention to have specified in Wallen adjusting the flow rate of the ventilator drive gas based on the mixer gas source includes setting the flow rate of the ventilator drive gas according to a composition of a mixer gas of the mixer gas source based upon an obvious expectation of using the outputs of both gas analyzer 23 and sensor unit 640, which each measure gas concentration, in order to make adjustments to the flow from both the claimed ventilator drive gas source and the claimed mixer gas source in order to successfully deliver the desired anesthetic gas concentration to the patient.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure, see PTO-892 for additional attached references. Regarding the independent claims further attention is specifically drawn to Heinonen et al. (U.S. Pub. 2010/0078018; Fig. 2 with long gas flow channel 41 as a bellowless plenum) and Broberg et al. (U.S. Pub. 2015/0250960; Figs. 4-5 read similarly to the readings from Wallen above).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOSEPH D BOECKER whose telephone number is (571)270-0376. The examiner can normally be reached M-F 9:00 AM - 4:00 PM.
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/JOSEPH D. BOECKER/Primary Examiner, Art Unit 3785