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 Arguments
This Office Action is in response to the Amendment filed 07/21/2025. As directed by the amendment, Claims 1, 3, 7, and 13 are amended and Claim 2 is cancelled. Claims 1 and 3-33 are pending in the application.
Regarding the Office Action filed 05/16/2025:
Applicant’s arguments, see Remarks pg. 14-19, filed 07/21/2025, with respect to the rejection(s) of amended claim(s) 1 and 13 under 103 with respect to Muller and Larsson have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Mullner and Hargasser.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Claim Objections
Claims 1, 3-12, and 14-33 are objected to because of the following informalities:
Claims 3-12 and 14-33, line 1, “A” should be “The” as the claims are dependent on other claims.
“connection element” should be “patient connection element” for the sake of clarity, in the following claims: claim 1 lines 37, 40, and 41; claim 6 line 4; claim 7 line 4; claim 8 line 4; claim 15 lines 2 and 6; claim 23 line 3-4; claim 24 line 6; claim 27 line 3; claim 33 line 4.
Claim 14, line 2, “a reflection unit” should be “the reflection unit”.
Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
“breathing gas connection system” in claim 1,
structure provided in specifications [0033].
“patient connection element” in claim 1,
structure provided in specifications [0033].
“switching unit” in claim 1 and 13,
structure provided in specifications [0038] and [0061].
“dispensing system” in claim 1.
structure provided in specifications [0049].
“connection element” in claim 13,
structure provided in specifications [0033].
“gas feed unit” in claim 15,
structure provided in specifications [0033].
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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, 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(s) 1, 3-8, 10-11, and 13-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mullner (US 20080029091 A1) and Hargasser (US 20100258117 A1).
Regarding claim 1, Mullner discloses a ventilating and oxygenating system for ventilating and oxygenating a patient (Method and Device for Administering Xenon to Patients; Title), the ventilating and oxygenating system comprising:
a ventilation system ([0022] ventilator/anesthesia device V; Fig. 1) configured with devices for supplying breathing gases to the patient with a breathing gas connection system connected to the ventilation system ([0033] artificial respiration is administered to a patient P by means of an anesthesia device V via a line 1. The respiratory gas stream that is exhaled by the patient P is fed back to the anesthesia device V via the line 1'; Fig. 1), wherein the breathing gas connection system is configured for a gas-carrying connection for a supply with feeding and removal of breathing gases to the patient ([0033] artificial respiration is administered to a patient P by means of an anesthesia device V via a line 1. The respiratory gas stream that is exhaled by the patient P is fed back to the anesthesia device V via the line 1'; Fig. 1);
an oxygenation system with an oxygenation connection system ([0033] CPB system (M, 2, 2’); Fig. 1), wherein the oxygenation system comprises a membrane configured for a gas exchange with a blood circulation of the patient ([0033] patient P is connected via a membrane M--depicted by the line 13 that is shown in dotted lines and that symbolizes a hose system via which the blood of the patient is pumped through the oxygenator--to a CPB system, depicted by the lines 2 and 2'; Fig. 1) with a feed of a quantity of oxygen ([0038] control unit S can be associated in addition--as depicted in the FIGURE--via line 8 with at least one additional source G of a one- or multi-component gas or gas mixture. In this connection, the source G is used in particular for the storage and dispensing of gas mixtures, such as air, oxygen, carbon dioxide, nitrogen oxide, anesthesia gases, volatile anesthesias, etc; Fig. 1) and of a quantity of inhalable and/or volatile substances into the blood circulation of the patient ([0037] control unit S is connected via the line 3 to a source X of xenon and/or a xenon-containing medium, in particular a xenon-containing gas mixture; Fig. 1) and for removing carbon dioxide from the blood circulation of the patient ([0034] Since the gas (mixture) that leaves the oxygenator is in most cases enriched with CO.sub.2, the gas (mixture), before it is fed back to the oxygenator, is preferably guided through a CO.sub.2-absorber and/or adsorber, not depicted in the FIGURE, and thus reduces the CO.sub.2 concentration; Fig. 1), and wherein the oxygenation system comprises devices for feeding and/or supplying a quantity of purge gas to the membrane ([0037] control unit S is connected via the line 3 to a source X of xenon and/or a xenon-containing medium, in particular a xenon-containing gas mixture; Fig. 1) and wherein the oxygenation connection system is configured to supply the patient with quantities of blood enriched with the inhalable and/or volatile substances and with oxygen ([0039] Based on the determined xenon content(s) in the inhalation system and/or the CPB system, xenon or a xenon-containing medium in the desired concentration can be added in measured quantities to the latter via the lines 4 and/or 5; Fig. 1) and remove quantities of blood enriched with carbon dioxide (Since the gas (mixture) that leaves the oxygenator is in most cases enriched with CO.sub.2, the gas (mixture), before it is fed back to the oxygenator, is preferably guided through a CO.sub.2-absorber and/or adsorber, not depicted in the FIGURE, and thus reduces the CO.sub.2 concentration; Fig. 1);
a sedation by inhalation system (the combination of elements ventilator/anesthesia device V, lines 1, 1’, 3, 4, 6, 8, 10, and 12, source of xenon and/or of a xenon-containing medium X, source for a one- or multi-component gas or gas mixture G, control, metering and supply unit S, and xenon-reprocessing or xenon-recovery unit W; Fig. 1) comprising a dispensing system configured to dispense the inhalable and/or volatile substances or volatile anesthetics ([0023] control, metering and supply unit S; Fig. 1. [0037] source of xenon and/or of a xenon-containing medium X and [0038] source of a one-or multi-component gas or gas mixture G (oxygen, carbon dioxide, nitrogen oxide, anesthesia gases, volatile anesthesias, etc.); Fig. 1), a gas removal port ([0041] gas line 10; Fig. 1. the inhalation system and the CPB system can be connected to a recovery unit or a reprocessing unit W via the lines 10 or 11, in which regulating valves b or c and optionally pumps P2 or P3 are also arranged. The latter unit is used in the recovery and optionally reprocessing of xenon from the gas or fluid mixtures of the inhalation system and/or CPB system), and a gas return port ([0042] the direct supply of the reprocessed xenon via the line 12, shown in dotted lines, to the xenon source X would also be conceivable; Fig. 1);
a breathing gas dispensing path ([0039] gas line 4; Fig. 1);
a purge gas dispensing path ([0039] gas line 5; Fig. 1);
a switching unit ([0023] S control, metering and supply unit; Fig. 1), wherein the switching unit is configured for splitting and/or distributing quantities of gas enriched with the inhalable and/or volatile substances into the breathing gas dispensing path and into the purge gas dispensing path ([0039] Based on the determined xenon content(s) in the inhalation system and/or the CPB system, xenon or a xenon-containing medium in the desired concentration can be added in measured quantities to the latter via the lines 4 and/or 5. In this connection, this addition of measured quantities in the system or the systems can take place either simultaneously or at other times; Fig. 1. [0049] it is advantageous that both systems can be supplied from a common source of xenon or of the xenon-containing medium. Examiner notes that S control, metering and supply unit is a functional equivalent to the switching unit disclosed as it comprises a control unit with the function of supplying gas to the inhalation system and/or the CPB system thereby being able to switch between supply to line 4 and/or 5), and is configured to feed and to supply a partial quantity of breathing gas enriched with the inhalable and/or volatile substances by means of the breathing gas dispensing path ([0039] Based on the determined xenon content(s) in the inhalation system and/or the CPB system, xenon or a xenon-containing medium in the desired concentration can be added in measured quantities to the latter via the lines 4 and/or 5; Fig. 1) and is configured to feed and to supply a partial quantity of breathing gas enriched with the inhalable and/or volatile substances to the oxygenation system by means of the purge gas dispensing path ([0039] Based on the determined xenon content(s) in the inhalation system and/or the CPB system, xenon or a xenon-containing medium in the desired concentration can be added in measured quantities to the latter via the lines 4 and/or 5; Fig. 1. [0033] The patient P is connected via a membrane M--depicted by the line 13 that is shown in dotted lines and that symbolizes a hose system via which the blood of the patient is pumped through the oxygenator--to a CPB system, depicted by the lines 2 and 2'; Fig. 1), wherein the breathing gas connection system is configured for feeding a partial quantity of breathing gas enriched with the inhalable and/or volatile substances from the switching unit ([0039] Based on the determined xenon content(s) in the inhalation system and/or the CPB system, xenon or a xenon-containing medium in the desired concentration can be added in measured quantities to the latter via the lines 4 and/or 5; Fig. 1.) and the breathing gas connection system is configured for feeding an additional partial quantity of breathing gas not enriched with inhalable and/or volatile substances from the ventilation system to the patient ([0033] artificial respiration is administered to a patient P by means of an anesthesia device V via a line 1; Fig. 1); and
a controller, comprising at least one control unit, configured for controlling the switching unit ([0035] Via a central control unit S, in which the necessary analysis and metering functions are implemented, the xenon contents in the inhalation system 1 and 1' as well as the CPB system 2 and 2' are determined via the measuring lines 6 and 7; Fig. 1).
Mullner is silent as to a patient connection system comprising a patient connection element located adjacent to the patient, the patient connection system being connected to the breathing gas connection system and the breathing gas connection system feeding quantities of gas by means of/via the patient connection element located adjacent the patient;
a reflection unit, the reflection unit being located adjacent to the patient connection element, wherein the reflection unit is configured to deliver the breathing gas directly to the connection element.
However, Hargasser teaches an anesthesia breathing system (Fig. 1 and 3) comprising:
a patient connection system comprising a patient connection element located adjacent to the patient (first conduit 2 and second conduit 3 including branching piece or Y piece 7; Fig. 1 and 3), the patient connection system being connected to a breathing gas connection system and the breathing gas connection system feeding quantities of gas by means of/via the patient connection element located adjacent the patient ([0042] This enables, for example, the removal and disposal of the exhausted breathable gas through the conduit 8 and the provision of fresh breathable gas through the supply conduit 9; Fig. 1 and 3);
a reflection unit ([0039] retaining filter 1; Fig. 1 and 3), the reflection unit being located adjacent to the patient connection element (Fig. 1 and 3), wherein the reflection unit is configured to deliver the breathing gas directly to the connection element ([0039] The first breathable gas mixture exhaled again is passed via the conduit 2 through the retaining filter 1, wherein part of the xenon contained in the gas mixture is adsorbed in the retaining filter. In the next breathing cycle, this adsorbed xenon can be discharged at least partially again into the second breathable gas mixture coming from the conduit 3).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Muller to implement a y-piece connection conduit adjacent to a retaining filter and connected to the breathing gas connection system and located adjacent to the patient via a larynx mask or endotracheal tube in order to recycle exhaled xenon while delivering breathing gas to a patient and discharging exhaled breathing gas, as taught by Hargasser [0038-0039]. As such, all gas flow to and from the patient flows through the patient connection element (y-piece connection conduit) and reflection unit (retaining filter) as modified above.
Additionally, the modified invention of Mullner teaches wherein the gas return port (12; Fig. 1), the reflection unit (H: retaining filter located adjacent to the patient at P Fig. 1 of Mullner) and the patient connection element system located adjacent to the patient (H: Y piece connection conduit and retaining filter located adjacent to the patient at P Fig. 1 of Mullner) are configured as a single assembly unit (the components in Fig. 1 of Mullner as modified are configured as a single assembly unit as each component is a collection of parts fitted together to form a complete unit/machine/assembly/system/device, etc.), the single assembly unit being located adjacent to the patient (see Fig. 1, the entire system is located adjacent to a patient P).
Regarding claim 3, the modified invention of Mullner discloses a ventilating and oxygenating system in accordance with claim 1, wherein the gas return port (M: 12; Fig. 1) is located adjacent to the reflection unit (H: retaining filter located adjacent to the patient at P Fig. 1 of Mullner) (the components of the modified invention of Mullner as seen in Fig. 1 are all located adjacent to each other via the lines connecting the entire system), the gas return port being located one side of the single assembly unit (M: line 12 located on a lower half and right half of the assembly unit depicted in Fig. 1), the patient connection element being located on another side of the single assembly unit (M: Y piece connection conduit located adjacent to the patient at P is located on a upper half and left half of the assembly unit depicted in Fig. 1 close to the patient), wherein the single assembly unit is configured to deliver the breathing gas directly to the patient via the patient connection system and the breathing gas connection system (M: [0033] artificial respiration is administered to a patient P by means of an anesthesia device V via a line 1. The respiratory gas stream that is exhaled by the patient P is fed back to the anesthesia device V via the line 1'. As modified, all gas flow to and from the patient flows through the patient connection element (y-piece connection conduit)).
Regarding claim 4, the modified invention of Mullner discloses a ventilating and oxygenating system in accordance with claim 1, wherein a filter element is arranged at the reflection unit (H: retaining filter 1; Fig. 1 and 3. [0012] The retaining filter essentially comprises an organic or inorganic adsorbent which is adapted to adsorb xenon and desorb it again. At the same time, the retaining filter should be essentially permeable to oxygen, carbon dioxide and nitrogen. For this purpose, for example, activated carbon, silica, aluminium oxide, aluminium silicate, zeolite or similar materials are conceivable).
Regarding claim 5, the modified invention of Mullner discloses a ventilating and oxygenating system in accordance with claim 4, but is silent as to wherein:
the filter element is configured as a heat and moisture exchanging (HME) filter for absorbing and releasing moisture; or
the filter element is configured as a filter for retaining germs, viruses or bacteria present in the breathing gas.
However, Hargasser teaches an anesthesia breathing system wherein the filter element is configured as a heat and moisture exchanging (HME) filter for absorbing and releasing moisture ([0040] The device further comprises a means 5 for exchanging heat and humidity. This means, for example, allows for partially absorbing the humidity contained in the exhaled breathable gas mixture and discharging it again into the breathable gas mixture to be inhaled. [0045] FIG. 3 schematically shows a variant of the preferred embodiment according to FIG. 1, in which the means 5 for exchanging heat and humidity as well as the retaining filter 1 are integrated in one part).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the retaining filter of modified Mullner to implement an integrated means for exchanging heat and humidity in order to allow for partially absorbing the humidity contained in the exhaled breathable gas mixture and discharging it again into the breathable gas mixture to be inhaled, as taught by Hargasser [0040].
Regarding claim 6, the modified invention of Mullner discloses a ventilating and oxygenating system in accordance with claim 4, wherein the gas removal port (M: 10; Fig. 1) and the gas return port (M: 12; Fig. 1) are configured in a common assembly unit with the reflection unit (H: retaining filter located adjacent to the patient at P Fig. 1 of Mullner) and/or with the breathing gas connection system (M: 1 and 1’; Fig. 1) and/or with the connection element located adjacent to the patient (H: Y-piece connection conduit located adjacent to the patient at P Fig. 1 of Muller) and/or with the filter element (H: retaining filter located adjacent to the patient at P Fig. 1 of Mullner) (Fig. 1 depicts the components connected to each other and all in one common assembly unit).
Regarding claim 7, the modified invention of Mullner discloses a ventilating and oxygenating system in accordance with claim 4, wherein the gas removal port (M: 10; Fig. 1) and the gas return port (M: 12; Fig. 1) are configured in the single assembly unit with the reflection unit (H: retaining filter located adjacent to the patient at P Fig. 1 of Mullner) and/or with the breathing gas connection system (M: 1 and 1’; Fig. 1) and/or with the connection element located adjacent to the patient (H: Y-piece connection conduit located adjacent to the patient at P Fig. 1 of Muller) and/or with the filter element (H: retaining filter located adjacent to the patient at P Fig. 1 of Mullner) (Fig. 1 depicts the components connected to each other and all in a single assembly unit as each component is a collection of parts fitted together to form a complete unit/machine/assembly/system/device, etc.), wherein the single assembly unit is configured to deliver the breathing gas directly to the breathing gas connection system (M: [0033] artificial respiration is administered to a patient P by means of an anesthesia device V via a line 1. The respiratory gas stream that is exhaled by the patient P is fed back to the anesthesia device V via the line 1'. As modified, all gas flow to and from the patient flows through the patient connection element (y-piece connection conduit)).
Regarding claim 8, the modified invention of Mullner discloses a ventilating and oxygenating system in accordance with claim 1, wherein the control unit is configured to control the dispensing system to control the dispensing of the inhalable and/or volatile substances on the basis of concentrations of inhalable and/or volatile substances determined at the breathing gas connection system (M: [0035] Via a central control unit S, in which the necessary analysis and metering functions are implemented, the xenon contents in the inhalation system 1 and 1' as well as the CPB system 2 and 2' are determined via the measuring lines 6 and 7. [0036] By means of the measuring lines 6 and 7, moreover, additional parameters of the inhalation system and/or CPB system, which are detected by means of corresponding measuring devices, can advantageously be forwarded to the control unit S. Such parameters are, for example, the concentrations of additional gas (mixture)s, flows, pressures, temperatures, etc.; Fig. 1).
Regarding claim 10, the modified invention of Mullner discloses a ventilating and oxygenating system in accordance with claim 1, wherein the dispensing system (M: the combination of elements [0023] control, metering and supply unit S, [0037] The control unit S is connected via the line 3 to a source X of xenon and/or a xenon-containing medium, in particular a xenon-containing gas mixture and [0038] control unit S can be associated in addition--as depicted in the FIGURE--via line 8 with at least one additional source G of a one- or multi-component gas or gas mixture); Fig. 1) is configured as a part of at least one of:
the sedation by inhalation system (M: the combination of elements ventilator/anesthesia device V, lines 1, 1’, 3, 4, 6, 8, 10, and 12, source of xenon and/or of a xenon-containing medium X, source for a one- or multi-component gas or gas mixture G, control, metering and supply unit S, and xenon-reprocessing or xenon-recovery unit W; Fig. 1); and
the ventilation system (M: The combination of elements S, line 3, X, line 8, and G are part of the ventilation system (V, 1, 1’) as the dispensing of breathing gases flows from control unit S to lines 1 and 1’ of the ventilation system [0038-0039]); and
the breathing gas connection system (M: The combination of elements S, line 3, X, line 8, and G are part of the breathing connection system as the dispensing of breathing gases flows from control unit S to lines 1 and 1’ [0038-0039]) .
Regarding claim 11, the modified invention of Mullner discloses a ventilating and oxygenating system in accordance with claim 1, wherein the switching unit (M: [0023] S control, metering and supply unit; Fig. 1) is configured as a part of at least one of:
the sedation by inhalation system (M: the combination of elements ventilator/anesthesia device V, lines 1, 1’, 3, 4, 6, 8, 10, and 12, source of xenon and/or of a xenon-containing medium X, source for a one- or multi-component gas or gas mixture G, control, metering and supply unit S, and xenon-reprocessing or xenon-recovery unit W; Fig. 1);
the ventilation system (M: control, metering, and supply unit S is part of the ventilation system (V, 1, 1’) as breathing gases flow from control unit S to lines 1 and 1’ of the ventilation system [0038-0039]; Fig. 1);
the breathing gas connection system (M: control, metering, and supply unit S is part of the breathing gas connection system as breathing gases flow from control unit S to lines 1 and 1’ [0038-0039]; Fig. 1);
the oxygenation connection system (M: control, metering, and supply unit S is part of the oxygenation connection system as gases flow from control unit S to lines 2 and 2’ [0038-0039]; Fig. 1);
the purge gas dispensing path (M: control, metering, and supply unit S is part of the purge gas dispensing path as gases flow from control unit S to line 5 [0039]; Fig. 1);
the breathing gas dispensing path (M: control, metering, and supply unit S is part of the breathing gas dispensing path as gases flow from control unit S to line 4 [0039]; Fig. 1);
and the dispensing system (M: the combination of elements [0023] control, metering and supply unit S, [0037] The control unit S is connected via the line 3 to a source X of xenon and/or a xenon-containing medium, in particular a xenon-containing gas mixture and [0038] control unit S can be associated in addition--as depicted in the FIGURE--via line 8 with at least one additional source G of a one- or multi-component gas or gas mixture); Fig. 1).
Regarding claim 13, Mullner discloses a gas splitting unit for a ventilating and oxygenating system for ventilating and oxygenating a patient (Method and Device for Administering Xenon to Patients; Title), the gas splitting unit comprising:
a switching unit ([0023] S control, metering and supply unit; Fig. 1; see [0038-0039]. Examiner notes that S control, metering and supply unit is a functional equivalent to the switching unit disclosed as it comprises a control unit with the function of supplying gas to the inhalation system and/or the CPB system thereby being able to switch between supply to line 4 and/or 5);
a breathing gas dispensing path ([0039] gas line 4 and lines 1 and 1’; Fig. 1. [0039] Based on the determined xenon content(s) in the inhalation system and/or the CPB system, xenon or a xenon-containing medium in the desired concentration can be added in measured quantities to the latter via the lines 4 and/or 5; Fig. 1);
a gas removal port configured to remove partial quantities of breathing gas from inhalation gas ([0041] the inhalation system and the CPB system can be connected to a recovery unit or a reprocessing unit W via the lines 10 or 11, in which regulating valves b or c and optionally pumps P2 or P3 are also arranged. The latter unit is used in the recovery and optionally reprocessing of xenon from the gas or fluid mixtures of the inhalation system and/or CPB system; Fig. 1);
a gas return port for inhalation gas ([0042] the direct supply of the reprocessed xenon via the line 12, shown in dotted lines, to the xenon source X would also be conceivable; Fig. 1);
and a purge gas dispensing path ([0039] gas line 5; Fig. 1).
Mullner is silent as to the breathing gas dispensing path comprising a reflection unit; a connection element located adjacent to the patient; wherein the reflection unit is configured to deliver the breathing gas directly to the connection element.
However, Hargasser teaches an anesthesia breathing system (Fig. 1 and 3) comprising:
a connection element located adjacent to the patient (first conduit 2 and second conduit 3 including branching piece or Y piece 7; Fig. 1 and 3);
a reflection unit ([0039] retaining filter 1; Fig. 1 and 3), wherein the reflection unit is located in a breathing gas dispensing path ([0042] path of conduit 9, conduit 3, and conduit 2; Fig. 1 and 3), wherein the reflection unit is configured to deliver the breathing gas directly to the connection element ([0039] The first breathable gas mixture exhaled again is passed via the conduit 2 through the retaining filter 1, wherein part of the xenon contained in the gas mixture is adsorbed in the retaining filter. In the next breathing cycle, this adsorbed xenon can be discharged at least partially again into the second breathable gas mixture coming from the conduit 3).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Muller to implement a y-piece connection conduit adjacent to a retaining filter and connected to the breathing gas dispensing path and located adjacent to the patient via a larynx mask or endotracheal tube in order to recycle exhaled xenon while delivering breathing gas to a patient and discharging exhaled breathing gas, as taught by Hargasser [0038-0039]. As such, all gas flow to and from the patient flows through the patient connection element (y-piece connection conduit) and reflection unit (retaining filter) as modified above.
Further regarding claim 13, the modified invention of Mullner discloses the gas return port being located adjacent to the connection element (M: the gas return port 12 is located adjacent to the Y-piece connection conduit at P/ lines 1 and 1’ as the components of the device of Mullner as seen in Fig. 1 are all located adjacent to each other via the lines connecting the entire system), wherein at least the switching unit (M: [0023] S control, metering and supply unit; Fig. 1), the breathing gas dispensing path (M: [0039] gas line 4 and lines 1 and 1’; Fig. 1), the connection element located adjacent to the patient (H:Y-piece connection conduit at P Fig. 1 of Muller), the gas removal port (M: [0041] gas line 10; Fig. 1), and the gas return port (M: [0041] gas line 12; Fig. 1) form a common assembly unit (Fig. 1 depicts the components connected to each other and all in one common assembly unit), the common assembly comprising a single assembly structure located adjacent to the patient (the components in Fig. 1 of Mullner as modified are configured as a single assembly unit as each component is a collection of parts fitted together to form a complete unit/machine/assembly/system/device, etc. and is located adjacent to the patient P during use), the single assembly structure comprising the gas removal port (M: [0041] gas line 10; Fig. 1), the reflection unit (H: retaining filter located adjacent to the patient at P Fig. 1 of Mullner) and the connection element (H: Y piece connection conduit at P Fig. 1 of Muller).
Regarding claim 14, the modified invention of Mullner discloses a gas splitting unit in accordance with claim 13, wherein the gas splitting unit further comprises a reflection unit (H: retaining filter located adjacent to the patient at P Fig. 1 of Mullner) and/or an additional filter element (M: Claim 7-wherein the CPB system (M, 2, 2') has a CO.sub.2 absorber, a CO.sub.2 adsorber and/or a CO.sub.2 filtering device, preferably a permeative CO.sub.2 filtering device) in the common assembly unit (Fig. 1 depicts the components connected to each other and all in one common assembly unit).
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mullner (US 20080029091 A1) and Hargasser (US 20100258117 A1) as applied to claim 8 above, and further in view of Kuzelka (US 20190099542 A1).
Regarding claim 9, the modified invention of Mullner discloses a system in accordance with claim 8, but does not explicitly disclose wherein the control unit is configured to control the dispensing system to control the dispensing of the inhalable and/or volatile substances on the basis of an end-tidal concentration of at least one inhalable substance or of at least one anesthetic.
However, Kuzelka teaches a ventilation and oxygenation system (Anesthesia system for Cardiopulmonary Bypass Machine; Title) wherein the control unit is configured to control the dispensing system to control the dispensing of the inhalable and/or volatile substances on the basis of an end-tidal concentration of at least one inhalable substance or of at least one anesthetic ([0078] a vaporizer of the anesthesia machine (e.g., similar to vaporizer 14 described above with reference to FIGS. 1A-1C) may vaporize liquid anesthetic agent stored in one or more containers on the anesthesia machine. The vaporizer may mix the vaporized anesthetic agent with gases (e.g., oxygen, air, etc.) and flow the mixture through the breathing circuit to the airway of the patient until the patient is sufficiently sedated for a cardiopulmonary bypass procedure (e.g., unconscious). The amount (e.g., concentration) of the anesthetic agent supplied to the breathing circuit may be controlled (e.g., manually by an anesthesiologist or automatically by the controller of the anesthesia machine) based on output from the respiratory gas module. For example, the respiratory gas module may measure the end-tidal concentration of the anesthetic agent mixed with the gases in the breathing circuit and allow for control of the concentration of anesthetic agent relative to the minimum alveolar concentration, adjusted for patient age, ambient temperature, and ambient pressure, for example; Fig. 6A-6B).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Mullner to implement the control unit detecting the end-tidal concentration of the anesthetic and allowing for the control of the delivered anesthetic gas based on the detected end-tidal concentration in order to ensure sufficient sedation of the patient as taught by Kuzelka [0078], and to prevent over-sedation.
Claim(s) 12, 15-16, 18, 21-26, and 32-33 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mullner (US 20080029091 A1) and Hargasser (US 20100258117 A1) as applied to claim 1 above, and further in view of Joost et al. (US 20140216252 A1).
Regarding claim 12, the modified invention of Mullner discloses a ventilating and oxygenating system in accordance with claim 1, further comprising a blood feed unit, for transporting quantities of blood to the patient and/or away from the patient, arranged in or at the oxygenation connection system and/or at the oxygenation system (M: [0033] the patient P is connected via a membrane M--depicted by the line 13 that is shown in dotted lines and that symbolizes a hose system via which the blood of the patient is pumped through the oxygenator--to a CPB system, depicted by the lines 2 and 2'; Fig. 1), but does not explicitly disclose wherein the purge gas is configured to receive the carbon dioxide from the blood circulation of the patient at the membrane.
However, Mullner teaches [0033] the patient P is connected via a membrane M--depicted by the line 13 that is shown in dotted lines and that symbolizes a hose system via which the blood of the patient is pumped through the oxygenator--to a CPB system, depicted by the lines 2 and 2’. [0034] The CPB system consists of, for example, a pump, which repeatedly supplies the gas already guided through the oxygenator to the oxygenator, by which a closed system is produced. Since the gas (mixture) that leaves the oxygenator is in most cases enriched with CO.sub.2, the gas (mixture), before it is fed back to the oxygenator, is preferably guided through a CO.sub.2-absorber and/or adsorber, not depicted in the FIGURE, and thus reduces the CO.sub.2 concentration; Fig. 1). Examiner notes that if the gas leaving the oxygenator is enriched with co2, the gas must receive the CO2 from the patient’s blood circulation and therefore the purge gas receives the carbon dioxide from the blood circulation of the patient.
Additionally, Joost teaches an arrangement for removing carbon dioxide from an extracorporeal flow of blood ([0027] arrangement 10 comprises a filter designed as an oxygenator 12 and having a blood region 14 and a gas region 18 separated from this blood region 14 via a membrane 16. The extracorporeal flow of blood is passed through the blood region 14 according to the arrows P1 and P2, for which a supply line 20 and a discharge line 22 are provided; Fig. 1), wherein the purge gas ([0028] A purge gas contained in a storage tank 24 and supplied to the gas region 18 via a supply line 26 is passed through the gas region 18, which is indicated by the arrow P3; Fig. 1) is configured to receive the carbon dioxide from the blood circulation of the patient at the membrane ([0029] As a result of the pressure difference of the partial pressure of the carbon dioxide between the blood region 14 and the gas region 18 or the concentration difference between the blood region 14 and the gas region 18, carbon dioxide is removed from the flow of blood through the membrane 16 and is supplied to the purge gas so that the carbon dioxide content of the flow of blood is reduced; Fig. 1. Also see [0004] and [0044]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the oxygenator of Mullner to implement a filter having a blood region and a gas region as taught by Joost in order to facilitate the removal of carbon dioxide from a patient’s blood [0028]-[0029] and additionally, it the purge gas comprises oxygen, to facilitate the oxygenation of blood [0004] and [0044].
Regarding claim 15, the modified invention of Mullner discloses a system in accordance with claim 1, wherein:
the switching unit (M: [0023] S control, metering and supply unit; Fig. 1), the breathing gas dispensing path (M: [0039] gas line 4; Fig. 1), the connection element located adjacent to the patient (H: Y piece connection conduit located adjacent to the patient at P Fig. 1 of Muller), the gas removal port, which is configured to remove partial quantities of breathing gas from inhalation gas (M: [0041] the inhalation system and the CPB system can be connected to a recovery unit or a reprocessing unit W via the lines 10 or 11, in which regulating valves b or c and optionally pumps P2 or P3 are also arranged. The latter unit is used in the recovery and optionally reprocessing of xenon from the gas or fluid mixtures of the inhalation system and/or CPB system; Fig. 1), the gas return port for inhalation gas (M: [0042] the direct supply of the reprocessed xenon via the line 12, shown in dotted lines, to the xenon source X would also be conceivable; Fig. 1), and the purge gas dispensing path (M: [0039] gas line 5; Fig. 1), comprise a gas splitting unit;
at least the switching unit (M: [0023] S control, metering and supply unit; Fig. 1), the breathing gas dispensing path ([0039] gas line 4; Fig. 1), the connection element located adjacent to the patient (H: Y-piece connection conduit located adjacent to the patient at P Fig. 1 of Muller), and the gas removal port (M: [0041] gas line 10; Fig. 1), the gas return port (M: [0041] gas line 12; Fig. 1) form a common assembly unit (Fig. 1 depicts the components connected to each other and all in one common assembly unit); and
a gas feed unit, configured to transport purge gas, is arranged in the oxygenation system (M: [0034] The CPB system consists of, for example, a pump, which repeatedly supplies the gas already guided through the oxygenator to the oxygenator, by which a closed system is produced), at least a portion of the purge gas dispensing path being located adjacent to a membrane of the oxygenation system (M: gas line 5 is located adjacent to membrane M of the CPB system as can be seen by the connection of M and line 5 via lines 2 and 2’. The components of the device of Mullner as seen in Fig. 1 are all located adjacent to each other via the lines connecting the entire system), but does not explicitly disclose wherein the purge gas is configured to receive carbon dioxide from blood circulation of the patient at the membrane.
However, Mullner teaches [0033] the patient P is connected via a membrane M--depicted by the line 13 that is shown in dotted lines and that symbolizes a hose system via which the blood of the patient is pumped through the oxygenator--to a CPB system, depicted by the lines 2 and 2’. [0034] The CPB system consists of, for example, a pump, which repeatedly supplies the gas already guided through the oxygenator to the oxygenator, by which a closed system is produced. Since the gas (mixture) that leaves the oxygenator is in most cases enriched with CO.sub.2, the gas (mixture), before it is fed back to the oxygenator, is preferably guided through a CO.sub.2-absorber and/or adsorber, not depicted in the FIGURE, and thus reduces the CO.sub.2 concentration; Fig. 1). Examiner notes that if the gas leaving the oxygenator is enriched with co2, the gas must receive the CO2 from the patient’s blood circulation and therefore the purge gas receives the carbon dioxide from the blood circulation of the patient.
Additionally, Joost teaches an arrangement for removing carbon dioxide from an extracorporeal flow of blood ([0027] arrangement 10 comprises a filter designed as an oxygenator 12 and having a blood region 14 and a gas region 18 separated from this blood region 14 via a membrane 16. The extracorporeal flow of blood is passed through the blood region 14 according to the arrows P1 and P2, for which a supply line 20 and a discharge line 22 are provided; Fig. 1), wherein the purge gas ([0028] A purge gas contained in a storage tank 24 and supplied to the gas region 18 via a supply line 26 is passed through the gas region 18, which is indicated by the arrow P3; Fig. 1) is configured to receive the carbon dioxide from the blood circulation of the patient at the membrane ([0029] As a result of the pressure difference of the partial pressure of the carbon dioxide between the blood region 14 and the gas region 18 or the concentration difference between the blood region 14 and the gas region 18, carbon dioxide is removed from the flow of blood through the membrane 16 and is supplied to the purge gas so that the carbon dioxide content of the flow of blood is reduced; Fig. 1. Also see [0004] and [0044]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the oxygenator of Mullner to implement a filter having a blood region and a gas region as taught by Joost in order to facilitate the removal of carbon dioxide from a patient’s blood [0028]-[0029] and additionally, it the purge gas comprises oxygen, to facilitate the oxygenation of blood [0004] and [0044].
Regarding claim 16, the modified invention of Mullner discloses a system in accordance with claim 15, wherein a purge gas absorber unit for removing carbon dioxide from the purge gas is arranged in the oxygenation system (M: [0034] Since the gas (mixture) that leaves the oxygenator is in most cases enriched with CO.sub.2, the gas (mixture), before it is fed back to the oxygenator, is preferably guided through a CO.sub.2-absorber and/or adsorber, not depicted in the FIGURE, and thus reduces the CO.sub.2 concentration. Claim 7- wherein the CPB system (M, 2, 2') has a CO.sub.2 absorber, a CO.sub.2 adsorber and/or a CO.sub.2 filtering device, preferably a permeative CO.sub.2 filtering device).
Regarding claim 18, the modified invention of Mullner discloses a system in accordance with claim 15, wherein the controller is configured as a central control unit (M: [0035] a central control unit S; Fig. 1).
Regarding claim 21, the modified invention of Mullner discloses a system in accordance with claim 15, wherein the controller takes into consideration respective provided data of the ventilation system and/or of the oxygenation system when controlling the switching unit (M: [0035] Via a central control unit S, in which the necessary analysis and metering functions are implemented, the xenon contents in the inhalation system 1 and 1' as well as the CPB system 2 and 2' are determined via the measuring lines 6 and 7. To keep the xenon consumption low, the analysis gas stream(s) is or are fed back to the inhalation system or the CPB system. [0036] By means of the measuring lines 6 and 7, moreover, additional parameters of the inhalation system and/or CPB system, which are detected by means of corresponding measuring devices, can advantageously be forwarded to the control unit S. Such parameters are, for example, the concentrations of additional gas (mixture)s, flows, pressures, temperatures, etc. [0039] Based on the determined xenon content(s) in the inhalation system and/or the CPB system, xenon or a xenon-containing medium in the desired concentration can be added in measured quantities to the latter via the lines 4 and/or 5; Fig. 1).
Regarding claim 22, the modified invention of Mullner discloses a system in accordance with claim 15, further comprising a process gas analysis unit (M: [0023] S control, metering and supply unit; Fig. 1) associated with the oxygenation system, wherein the process gas analysis unit is configured to provide gas analysis data determined based on an analysis for the system or for the controller (M: [0035] Via a central control unit S, in which the necessary analysis and metering functions are implemented, the xenon contents in the inhalation system 1 and 1' as well as the CPB system 2 and 2' are determined via the measuring lines 6 and 7. To keep the xenon consumption low, the analysis gas stream(s) is or are fed back to the inhalation system or the CPB system. [0036] By means of the measuring lines 6 and 7, moreover, additional parameters of the inhalation system and/or CPB system, which are detected by means of corresponding measuring devices, can advantageously be forwarded to the control unit S. Such parameters are, for example, the concentrations of additional gas (mixture)s, flows, pressures, temperatures, etc.; Fig. 1).
Regarding claim 23, the modified invention of Mullner discloses a system in accordance with claim 15, further comprising a process gas analysis unit, for an gas analysis (M: [0023] S control, metering and supply unit; Fig. 1), connected to the gas splitting unit (M: S control, metering and supply unit is part of the gas splitting unit) or to the connection element located adjacent to the patient by means of a measured gas line (M: S control, metering and supply unit is connected to the Y-piece connection conduit at patient P via breathing gas line 4 and the inhalation system lines 1 and 1’), or arranged in or at the sedation by inhalation system or is associated with the sedation by inhalation system (M: S control, metering and supply unit is part of the sedation by inhalation system unit), wherein the process gas analysis unit is configured to provide gas analysis data determined on the basis of the analysis for the sedation by inhalation system, for the system and/or for the controller (M: [0035] Via a central control unit S, in which the necessary analysis and metering functions are implemented, the xenon contents in the inhalation system 1 and 1' as well as the CPB system 2 and 2' are determined via the measuring lines 6 and 7. To keep the xenon consumption low, the analysis gas stream(s) is or are fed back to the inhalation system or the CPB system. [0036] By means of the measuring lines 6 and 7, moreover, additional parameters of the inhalation system and/or CPB system, which are detected by means of corresponding measuring devices, can advantageously be forwarded to the control unit S. Such parameters are, for example, the concentrations of additional gas (mixture)s, flows, pressures, temperatures, etc.; Fig. 1).
Regarding claim 24, the modified invention of Mullner discloses a system in accordance with claim 23, wherein: a central process gas analysis unit is arranged in the system or is associated with the system (M: [0023] S control, metering and supply unit; Fig. 1); the central process gas analysis unit is configured, together with a switching and distribution control unit, to carry out analyses of gas samples of the sedation by inhalation system, of the breathing gas connection system, of the connection element located adjacent to the patient, of the oxygenation system, of the oxygenation connection system, of the dispensing system or of the switching unit (M: S control, metering and supply unit meters gas via lines 6 and 7 from the inhalation and oxygenation system which includes the sedation by inhalation system, the breathing gas connection system, the connection element located adjacent to the patient, of the oxygenation system, the oxygenation connection system, the dispensing system and the switching unit) and/or to provide data determined on the basis of the analyses for the system and/or for the controller (M: [0035] Via a central control unit S, in which the necessary analysis and metering functions are implemented, the xenon contents in the inhalation system 1 and 1' as well as the CPB system 2 and 2' are determined via the measuring lines 6 and 7. To keep the xenon consumption low, the analysis gas stream(s) is or are fed back to the inhalation system or the CPB system. [0036] By means of the measuring lines 6 and 7, moreover, additional parameters of the inhalation system and/or CPB system, which are detected by means of corresponding measuring devices, can advantageously be forwarded to the control unit S. Such parameters are, for example, the concentrations of additional gas (mixture)s, flows, pressures, temperatures, etc.; Fig. 1).
Regarding claim 25, the modified invention of Mullner discloses a system in accordance with claim 23, wherein: a blood gas analysis unit for a blood analysis (M: [0023] S control, metering and supply unit; Fig. 1) is associated with the oxygenation system or with the oxygenation connection system (M: S control, metering and supply unit is associated with the oxygenation system and the oxygenation connection system via lines 5 and 7; Fig. 1); and the blood gas analysis unit is configured to provide data determined on the basis of the analysis for the oxygenation system, for the system and/or for the controller (M: [0035] Via a central control unit S, in which the necessary analysis and metering functions are implemented, the xenon contents in the inhalation system 1 and 1' as well as the CPB system 2 and 2' are determined via the measuring lines 6 and 7. To keep the xenon consumption low, the analysis gas stream(s) is or are fed back to the inhalation system or the CPB system. [0036] By means of the measuring lines 6 and 7, moreover, additional parameters of the inhalation system and/or CPB system, which are detected by means of corresponding measuring devices, can advantageously be forwarded to the control unit S. Such parameters are, for example, the concentrations of additional gas (mixture)s, flows, pressures, temperatures, etc.; Fig. 1).
Regarding claim 26, the modified invention of Mullner discloses a system in accordance with claim 23, wherein: a process gas analysis unit for a gas analysis (M: [0023] S control, metering and supply unit; Fig. 1) is arranged in or is associated with the switching unit or the dispensing system (M: S control, metering and supply unit is part of both switching unit and dispensing unit); and the process gas analysis unit is configured to provide gas analysis data determined on the basis of the analysis for the switching unit, for the dispensing system, for the system and/or for the controller ([0035] Via a central control unit S, in which the necessary analysis and metering functions are implemented, the xenon contents in the inhalation system 1 and 1' as well as the CPB system 2 and 2' are determined via the measuring lines 6 and 7. To keep the xenon consumption low, the analysis gas stream(s) is or are fed back to the inhalation system or the CPB system. [0036] By means of the measuring lines 6 and 7, moreover, additional parameters of the inhalation system and/or CPB system, which are detected by means of corresponding measuring devices, can advantageously be forwarded to the control unit S. Such parameters are, for example, the concentrations of additional gas (mixture)s, flows, pressures, temperatures, etc.; Fig. 1).
Regarding claim 32, the modified invention of Mullner discloses a system in accordance with claim 15, wherein the controller is configured to control a quantity of inhalable and/or volatile substances as a function of a data provided by the controller (M: [0035] Via a central control unit S, in which the necessary analysis and metering functions are implemented, the xenon contents in the inhalation system 1 and 1' as well as the CPB system 2 and 2' are determined via the measuring lines 6 and 7. To keep the xenon consumption low, the analysis gas stream(s) is or are fed back to the inhalation system or the CPB system. [0036] By means of the measuring lines 6 and 7, moreover, additional parameters of the inhalation system and/or CPB system, which are detected by means of corresponding measuring devices, can advantageously be forwarded to the control unit S. Such parameters are, for example, the concentrations of additional gas (mixture)s, flows, pressures, temperatures, etc. [0039] Based on the determined xenon content(s) in the inhalation system and/or the CPB system, xenon or a xenon-containing medium in the desired concentration can be added in measured quantities to the latter via the lines 4 and/or 5; Fig. 1).
Regarding claim 33, the modified invention of Mullner discloses a system in accordance with claim 15, wherein the controller is configured to control a distribution and/or a splitting of a quantity of inhalable and/or volatile substances into the purge dispensing path to the oxygenation system and into the breathing gas dispensing path to the connection element located adjacent to the patient or to the reflection unit as a function of the data provided by the controller (M: [0035] Via a central control unit S, in which the necessary analysis and metering functions are implemented, the xenon contents in the inhalation system 1 and 1' as well as the CPB system 2 and 2' are determined via the measuring lines 6 and 7. To keep the xenon consumption low, the analysis gas stream(s) is or are fed back to the inhalation system or the CPB system. [0036] By means of the measuring lines 6 and 7, moreover, additional parameters of the inhalation system and/or CPB system, which are detected by means of corresponding measuring devices, can advantageously be forwarded to the control unit S. Such parameters are, for example, the concentrations of additional gas (mixture)s, flows, pressures, temperatures, etc. [0039] Based on the determined xenon content(s) in the inhalation system and/or the CPB system, xenon or a xenon-containing medium in the desired concentration can be added in measured quantities to the latter via the lines 4 and/or 5; Fig. 1).
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mullner (US 20080029091 A1), Hargasser (US 20100258117 A1), and Joost (US 20140216252 A1) as applied to claim 15 above, and further in view of Heinonen (US 20150144135 A1).
Regarding claim 17, the modified invention of Mullner discloses a system in accordance with claim 15, but does not disclose further comprising a waste gas line extending from the ventilation system to the gas splitting unit or to the switching unit and configured to feed exhaled gases from the ventilation system to a mixing chamber arranged in or at the switching unit or in or at the gas splitting unit and the removal of carbon dioxide from the breathing gas.
However, Mullner teaches [0041] the inhalation system and the CPB system can be connected to a recovery unit or a reprocessing unit W via the lines 10 or 11, in which regulating valves b or c and optionally pumps P2 or P3 are also arranged. The latter unit is used in the recovery and optionally reprocessing of xenon from the gas or fluid mixtures of the inhalation system and/or CPB system. In this connection, the xenon recovery is carried out by means of suitable measures, such as, for example, filtering, absorption, adsorption, compression, etc; Fig. 1.
Additionally, Heinonen teaches an anesthesia breathing system with scavenging of expired gas and removal of CO2 [0002]. Specifically, Heinonen teaches [0016] The ventilator 1 is connected to the breathing circuit 2 with the reciprocating unit 8 for both inspired and expired gas flows. The breathing circuit 2 comprises an inspiration tube 18 for inspired gas, an expiration tube 19 for expired gas, a carbon dioxide (CO2) remover 20, such as CO2 absorber, to remove or absorb carbon dioxide from the exhaled gas coming from the subject 5, a first one way valve 21 for inspired gas in the inspiration tube 18, a second one way valve 22 for expired gas in the expiration tube 19, a branching unit 23, such as a Y-piece, having at least three limbs, one of them being an inhalation limb 24 for inspired gas, a second one being an expiration limb 25 for expired gas, a third one being a combined inspiration and expiration limb 26 for both inspired and expired gases; Fig. 1.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Mullner to include a line for expired gas flow and a CO2 absorber in the recovery unit connected to expiratory line in order to recirculate the expired gas to subsequent inspiration of the gases in the circuit to lower cost and environmental exhaust as taught by Heinonen [0002].
Claim(s) 19-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mullner (US 20080029091 A1), Hargasser (US 20100258117 A1), and Joost (US 20140216252 A1) as applied to claim 15 above, and further in view of Larsson (US 20190344005 A1).Regarding claim 19, the modified invention of Mullner discloses a system in accordance with claim 15, wherein: the controller comprises the at least one control unit (M: [0035] a central control unit S; Fig. 1) but does not disclose further individual control units forming a non-central control system; and at least one of the at least one control unit and further individual control units is arranged in the oxygenation system and in the ventilation system.
However, Larsson teaches a ventilation and oxygenation system (a system (1) for carbon dioxide [CO2] removal from the circulatory system of a patient (3), comprising a medical device (5) for providing extracorporeal lung assist [ECLA] treatment to the patient (3) through extracorporeal removal of CO2 from the patient's blood; Abstract) wherein the controller comprises the at least one control unit and further individual control units forming a non-central control system ([0072] the standalone monitor unit 47 comprises a control unit 22C which alone or in combination with any or both of the control units 22A and 22B provides the above described functionality. The control unit 22C is coupled to the bioelectric sensor 7 via a signalling link 49C and to the control units 22A, 22B of the ECLA device 5 and the ventilator 30 via a respective control link 51A and 51B; Fig. 3); and at least one of the at least one control unit and further individual control units is arranged in the oxygenation system ([0050] The sensors 17, 19, 21, the flow generator 9, and the oxygenator 13 are coupled to a control unit 22A of the ECLA device 5, which control unit 22A may be configured to automatically control the flow generator 9 and/or the oxygenator 13 based on sensor data obtained by the various sensors 17, 19, 21; Fig. 3) and in the ventilation system ([0058] The ventilator 30 further comprises a control unit 22B for controlling the ventilation of the patient 3 based on preset parameters and/or measurements obtained by various sensors of the ventilator, such as flow sensors, pressure sensors, gas analysers, etc. In this exemplary embodiment, the ventilator 30 comprises a first pressure and flow sensor arrangement 38A arranged in an inspiratory module of the ventilator, and a second pressure and flow sensor arrangement 38B arranged in an expiratory module of the ventilator 30; Fig. 3).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Mullner to implement individual control units at the oxygenation system and ventilation communicating with a main control unit in order to effectively control the parameters of both the oxygenation system and ventilation system as taught by Larsson [0027].
Regarding claim 20, the modified invention of Mullner discloses a system in accordance with claim 19, wherein:
at least one of the at least one control unit is arranged in the switching unit (M: [0023] S control, metering and supply unit; Fig. 1) and/or is arranged in the dispensing system and/or an external control unit is arranged in the non-central control system;
one of the individual control units (M: [0023] S control, metering and supply unit; Fig. 1) is configured as the at least one control unit to control the switching unit (M: [0039] Based on the determined xenon content(s) in the inhalation system and/or the CPB system, xenon or a xenon-containing medium in the desired concentration can be added in measured quantities to the latter via the lines 4 and/or 5. In this connection, this addition of measured quantities in the system or the systems can take place either simultaneously or at other times; Fig. 1) and/or the dispensing system (M: [0037-0039] control unit S controls the dispensing of gases from source X of xenon and/or source G).
Claim(s) 27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mullner (US 20080029091 A1), Hargasser (US 20100258117 A1), and Joost et al. (US 20140216252 A1) as applied to claim 15 above, and further in view of Assi et al. (WO 2016157106 A1).
Regarding claim 27, the modified invention of Mullner discloses a system in accordance with claim 15, but does not disclose wherein a humidifying/heating system for breathing gas is arranged for heating breathing gases in or at one or more of the gas splitting unit, the switching unit, the connection element located adjacent to the patient, and the breathing gas connection system.
However, Assi teaches an apparatus for oxygenation and/or CO2 removal (Title) wherein a humidifying/heating system for breathing gas is arranged for heating breathing gases in the breathing gas connection system (humidifier 17; Fig. 1 and 1C). Specifically, Assi teaches [00127] A humidifier 17 can optionally be provided between the flow source and the patient to provide humidification of the delivered gas. One or more sensors 18a, 18b, 18c, 18d, such as flow, oxygen fraction, pressure, humidity, temperature or other sensors can be placed throughout the system and/or at, on or near the patient 16. Alternatively, or additionally, sensors from which such parameters can be derived could be used. In addition, or alternatively, the sensors 18a-18d can be one or more physiological sensors for sensing patient physiological parameters such as, heart rate, oxygen saturation, partial pressure of oxygen in the blood, respiratory rate, partial pressure of C02 in the blood. Alternatively or additionally, sensors from which such parameters can be derived could be used. Other on patient sensors could comprise EEG sensors, torso bands to detect breathing, and any other suitable sensors. In some configurations the humidifier may be optional or it may be preferred due to the advantages of humidified gases helping to maintain the condition of the airways. One or more of the sensors might form part of the apparatus, or be external thereto, with the apparatus having inputs for any external sensors. [00137] The controller 19 can also control the humidifier 17 based on feed- back from the sensors 18a-18d; Fig. 1 and 1C.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Mullner to implement a humidifier in the breathing gas connection system controlled by feedback from sensors in order to help maintain the condition of the patient’s airways as taught by Assi [00127].
Claim(s) 28, 29, and 31 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mullner (US 20080029091 A1), Hargasser (US 20100258117 A1), and Joost et al. (US 20140216252 A1) as applied to claim 15 above, and further in view of Kuck et al. (US 20190151584 A1).
Regarding claim 28, the modified invention of Mullner discloses a system in accordance with claim 15, but does not disclose wherein:
a data network is arranged in or at the system or is associated with the system;
the data network is configured to provide data to at least one of the system, the controller, the blood gas analysis unit, the process gas analysis units, the ventilation system, the oxygenation system, the switching unit, the dispensing system, and the sedation by inhalation system to enable the controller to control and/or to coordinate the switching unit and/or the dispensing unit.
However, Kuck teaches a system for administering inhalational anesthetic agents ([0003]) comprising a data network at the system and associated with the system configured to provide data to the controller (Fig. 1D). Specifically, Kuck teaches [0068] The bus 113, and all buses specified in this description can also be implemented over a wired or wireless network connection and each of the subsystems, including the processor 103, a mass storage device 104, an operating system 105, control processing software 106, control processing data 107, a network adapter 108, system memory 112, an Input/Output Interface 110, a display adapter 109, a display device 111, and a human machine interface 102, can be contained within one or more remote computing devices 114a,b,c at physically separate locations, connected through buses of this form, in effect implementing a fully distributed system; Fig. 1D. [0073] Optionally, in exemplary aspects, the processor 32, 103 of the controller 30 disclosed herein can receive manual inputs from a user or other individual supervising the delivery of anesthetic agents to a patient. Such manual inputs can correspond to an identity of a delivered agent, desired agent concentrations or concentration limits, desired flow rates, desired flow pathway configurations (including instructions regarding opening, closing, or adjusting of the positions of any valves disclosed herein), or patient information (physical condition, age, weight, and the like). It is still further contemplated that the processor 32, 103 can be communicatively coupled to a memory as further disclosed herein that stores a pre-set profile corresponding to the patient or to a particular anesthesia administration protocol. In operation, the processor 32, 103 can make use of these instructions to provide a customized anesthesia delivery profile for the patient and ensure that any adjustments to the anesthesia delivery parameters or system configuration are consistent with the instructions; Fig. 1C and 1D. [0075] The computing device 101 can operate in a networked environment using logical connections to one or more remote computing devices 114a,b,c. By way of example, a remote computing device can be a personal computer, portable computer, smartphone, a tablet, a server, a router, a network computer, a peer device or other common network node, and so on. In exemplary aspects, a remote computing device can be operated by a clinician involved with the administration (or supervision of the administration) of anesthesia to the patient. Logical connections between the computing device 101 and a remote computing device 114a,b,c can be made via a network 115, such as a local area network (LAN) and/or a general wide area network (WAN). Such network connections can be through a network adapter 108. A network adapter 108 can be implemented in both wired and wireless environments; Fig. 1D.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Mullner to implement a remote computing device connected to the control unit(s) via a data network for an operator to remotely communicate inputs to be used to control and personalize a patient’s anesthesia protocol as taught by Kuck [0073].
Regarding claim 29, the modified invention of Mullner discloses a system in accordance with claim 15, but does not disclose further comprising a physiological patient monitoring system arranged in or connected to the system, wherein the physiological patient monitoring system is configured to provide physiological data for the system, for the ventilation system, for the oxygenation system, for the dispensing system, for the switching unit, for the controller and/or for a data network.
However, Kuck teaches a system for administering inhalational anesthetic agents ([0003]) comprising a physiological patient monitoring system arranged in or connected to the system, wherein the physiological patient monitoring system is configured to provide physiological data for the system and the controller. Specifically, Kuck teaches [0073] the processor 32, 103 can be communicatively coupled to other components, such as a heart rate monitor or other monitoring device that provides physiological feedback (e.g. heart rate) or other parameter measurements to the processor 32, 103.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Mullner to implement a heart rate monitor to provide heart rate feedback to the controller and system as taught by Kuck to monitor the patient [0073] and ensure patient safety.
Regarding claim 31, the modified invention of Mullner discloses a system in accordance with claim 15, but does not disclose wherein the system is configured to provide data with a data network in a data exchange.
However, Kuck teaches a system for administering inhalational anesthetic agents ([0003]) wherein the system is configured to provide data with a data network in a data exchange (Fig. 1D). Specifically, Kuck teaches [0068] The bus 113, and all buses specified in this description can also be implemented over a wired or wireless network connection and each of the subsystems, including the processor 103, a mass storage device 104, an operating system 105, control processing software 106, control processing data 107, a network adapter 108, system memory 112, an Input/Output Interface 110, a display adapter 109, a display device 111, and a human machine interface 102, can be contained within one or more remote computing devices 114a,b,c at physically separate locations, connected through buses of this form, in effect implementing a fully distributed system; Fig. 1D. [0073] Optionally, in exemplary aspects, the processor 32, 103 of the controller 30 disclosed herein can receive manual inputs from a user or other individual supervising the delivery of anesthetic agents to a patient. Such manual inputs can correspond to an identity of a delivered agent, desired agent concentrations or concentration limits, desired flow rates, desired flow pathway configurations (including instructions regarding opening, closing, or adjusting of the positions of any valves disclosed herein), or patient information (physical condition, age, weight, and the like). It is still further contemplated that the processor 32, 103 can be communicatively coupled to a memory as further disclosed herein that stores a pre-set profile corresponding to the patient or to a particular anesthesia administration protocol. In operation, the processor 32, 103 can make use of these instructions to provide a customized anesthesia delivery profile for the patient and ensure that any adjustments to the anesthesia delivery parameters or system configuration are consistent with the instructions; Fig. 1C and 1D. [0075] The computing device 101 can operate in a networked environment using logical connections to one or more remote computing devices 114a,b,c. By way of example, a remote computing device can be a personal computer, portable computer, smartphone, a tablet, a server, a router, a network computer, a peer device or other common network node, and so on. In exemplary aspects, a remote computing device can be operated by a clinician involved with the administration (or supervision of the administration) of anesthesia to the patient. Logical connections between the computing device 101 and a remote computing device 114a,b,c can be made via a network 115, such as a local area network (LAN) and/or a general wide area network (WAN). Such network connections can be through a network adapter 108. A network adapter 108 can be implemented in both wired and wireless environments; Fig. 1D. Fig. 1D depicts the two way communication of data from computing device 101 to network 116 and from network 116 to remote computing device 114a-c and vice versa.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Mullner to implement a remote computing device connected to the control unit(s) via a data network for an operator for two-way communicate of data that can be used to control and personalize a patient’s anesthesia protocol as taught by Kuck [0073].
Claim(s) 30 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mullner (US 20080029091 A1), Hargasser (US 20100258117 A1), and Joost et al. (US 20140216252 A1) as applied to claim 15 above, and further in view of Oldfield et al. (US 20180071469 A1).
Regarding claim 30, the modified invention of Mullner discloses a system in accordance with claim 15, but does not disclose further comprising a heart and lung imaging and diagnostic system arranged in or connected to the system, wherein the heart and lung imaging and diagnostic system is configured to provide data for the system, for the ventilation system, for the oxygenation system, for the dispensing system, for the switching unit, for a physiological patient monitoring system, for the controller and/or for a data network.
However, Oldfield teaches a ventilation system (Apparatus for Controlling Gas Delivery to a Patient; Title) comprising a heart and lung imaging and diagnostic system arranged in or connected to the system, wherein the heart and lung imaging and diagnostic system is configured to provide data for the system, for the ventilation system and for the controller. Specifically, Oldifield teaches [0248] A controller 18 is also provided, that controls various operations of the system/apparatus 1. Among other connections, the controller is connected to the valve(s) 13 and to a portion of the system 1 that senses/monitors a patient's breathing phases and/or another patient parameter (including but not limited to: a patient's chest movements such as chest compressions using Electrical Impedance Tomography bands (referred to as EIT bands), oxygen saturation of the patient (e.g. via pulse oximeter), or patient CO2 output to provide an indicator of a patient's breathing phase or an exhalation phase of the patient, or one or more pressure sensors may be utilised (e.g. pressure sensors can be used to measure pressure in a patient airway or alternatively measure a differential pressure in the supply tube or conduit to determine the inspiration phase or expiration phase of the patient), such as the breathing circuit 15 or patient interface 16 or other sensors or monitoring devices for sensing or monitoring other patient parameters.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Mullner to implement a monitoring device connected to the control for sensing/monitoring a patient’s breathing phases and chest compressions using Electrical Impedance Tomography (EIT) as taught by Oldfield to monitor the patient [0248] and ensure patient safety.
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 Mautin I Ashimiu whose telephone number is (571)272-0760. The examiner can normally be reached Monday - Friday, 7:30 a.m. - 4:30 p.m. ET.
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/M.I.A./Examiner, Art Unit 3785
/VALERIE L WOODWARD/Primary Examiner, Art Unit 3785
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