DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of Claims
The present Office action is responsive to the preliminary amendment filed on 02-28-2024. As directed, claims 1-15 have been amended and new claims 16-17 have been added. Thus, claims 1-17 are presently pending examination.
Claim Objections
Claims 1-17 are objected to because of the following informalities:
At claim 1, line 17, it is suggested that “the supply” be replaced with “a supply” as the limitation has not been previously introduced.
At claim 1, lines 22-23, it is suggested that “on the basis” be replaced with “based on” for clarity.
At claim 1, line 25, it is suggested that “bring about” be replaced with “cause” for clarity.
At claim 1, line 26, it is suggested that “on the basis” be replaced with “based on” for clarity.
At claims 2-9, line 1, it is suggested that “An assembly” be replaced with “The assembly” as the assembly is already introduced in claim 1.
At claim 2, line 7, it is suggested that “also include” be replaced with “further include” for clarity.
At claim 2, lines 8-9, it is suggested that “the bringing about of” be eliminated for clarity.
At claim 3, line 6, it is suggested that “also include” be replaced with “further include” for clarity.
At claim 3, line 7, it is suggested that “the bringing about of” be eliminated for clarity.
At claim 4, line 6, it is suggested that “also include” be replaced with “further include” for clarity.
At claim 4, line 7, it is suggested that “further” or “additionally” be added before “indicate flow rates” for clarity.
At claim 5, line 8, it is suggested that “also include” be replaced with “further include” for clarity.
At claim 5, line 9, it is suggested that “respective” be added before “oxygen concentration” for clarity.
At claim 5, line 9, it is suggested that “the bringing about of” be eliminated for clarity.
At claim 6, line 3, it is suggested that “also take into account” be replaced with “further account for” for clarity.
At claim 6, line 3, it is suggested that “the first pressure sensor” be replaced with “a first pressure sensor” as claim 1 does not provide antecedent basis for the term.
At claim 6, line 4, it is suggested that “the additional pressure sensor” be replaced with “an additional pressure sensor” as claim 1 does not provide antecedent basis for the term.
At claim 6, lines 4-5, it is suggested that “the additional flow sensor” be replaced with “an additional flow sensor” as claim 1 does not provide antecedent basis for the term.
At claim 6, line 5, it is suggested that “the oxygen sensor” be replaced with “an oxygen sensor” as claim 1 does not provide antecedent basis for the term.
At claim 6, lines 5-6, it is suggested that “during the control of the operation with bringing about of changes of state” be replaced with “during the operation when the control unit is configured to cause the state of change” for clarity.
At claim 9, lines 1-2, it is suggested that “or ventilator” be eliminated, as the remainder of the claim and its dependents do not refer back to the ventilator, only the “anesthesia device”.
At claim 9, line 7, it is suggested that “the supply” be replaced with “a supply” as the limitation has not yet been introduced.
At claim 9, line 9, it is suggested that “acquiring a measured signal with a detection of measured signals” be replaced with “acquiring and detecting measured signals” for clarity.
At claim 9, line 12, it is suggested that “on the basis of” be replaced with “based on” for clarity, as “the basis” lacks antecedent basis.
At claim 9, line 12, it is suggested that the comma following the semi-colon be eliminated.
At claim 9, lines 16-17, it is suggested that “wherein the determination is carried out to determine whether an operating state is present, in which certain partial quantities or quantities of” be replaced with “wherein the determination of the operating state further indicates whether the operating state allows certain partial quantities or quantities of” for clarity. If this suggestion is taken, “to” should also be added before “flow” in line 18.
At claim 9, line 18, it is suggested that “the patient” be replaced with “a patient” as the limitation has not yet been introduced.
At line 1 of claims 10-14, “A process for operating an” should be replaced with “The process for operating the” as the limitations were previously introduced.
At claim 10, line 3, it is suggested that “the measured signal analysis” be replaced with “the measured value analysis” for consistency with claim 9, line 11.
At claim 10, lines 3-4, it is suggested that “the current inspiratory tidal volume” be replaced with “a current inspiratory tidal volume” as the limitation has not been introduced.
At claim 10, line 4, it is suggested that “the phase of inhalation” be replaced with “a current phase of inhalation” as the limitation has not been introduced.
At claim 10, line 4, it is suggested that “on the basis” be replaced with “based on” as basis lacks antecedent basis.
At claim 10, line 9, it is suggested that “the current tidal volume” be replaced with “the current inspiratory tidal volume” for consistency with line 3.
At claim 11, lines 3-4, it is suggested that “does not take place during each phase of breathing, but only from time to time or proportionally” be replaced with “occurs temporarily or proportionally” in accordance with the instant specification at paragraph 89.
At claim 12, line 3, it is suggested that “the activation” be replaced with “an activation” or that the claim be amended to depend from claim 10, as a/the activation is recited in claim 10 as opposed to claim 9.
At claim 12, line 4, it is suggested that “a closed anesthesia system” be replaced with “a closed system” to differentiate from the anesthesia system that has already been introduced.
At claim 12, line 4, it is suggested that “an open anesthesia system” be replaced with “an open system” to differentiate from the anesthesia system that has already been introduced.
At claim 12, line 5, it is suggested that “first” be added before “defined volume range” to distinguish between the volume range of line 8.
At claim 12, line 6, it is suggested that “the deactivation” be replaced with “a deactivation” as the limitation has not been introduced.
At claim 12, lines 8, it is suggested that “second” be added before “defined volume range” to distinguish between the volume range of line 5.
At claim 12, line 7, it is suggested that “a closed anesthesia system” be replaced with “the closed system” to differentiate from the anesthesia system that has already been introduced, and in accordance with a previous suggestion.
At claim 12, line 7, it is suggested that “an open anesthesia system” be replaced with “the open system” to differentiate from the anesthesia system that has already been introduced, and in accordance with a previous suggestion.
At claim 13, lines 3-4, it is suggested that “a closed anesthesia system” be replaced with “the closed system” to differentiate from the anesthesia system that has already been introduced, and in accordance with a previous suggestion.
At claim 13, line 4, it is suggested that “an open anesthesia system” be replaced with “the open system” to differentiate from the anesthesia system that has already been introduced, and in accordance with a previous suggestion.
At claim 13, line 4, it is suggested that “on the basis” be replaced with “based on” as basis lacks antecedent basis.
At claim 13, line 5, it is suggested that “on the basis” be replaced with “based on” as basis lacks antecedent basis.
At claim 13, lines 5-6, it is suggested that “the breathing gas” be replaced with “the breathing gases” for consistency with claim 9, lines 4-5.
At claim 14, line 3, it is suggested that “a closed anesthesia system” be replaced with “the closed system” to differentiate from the anesthesia system that has already been introduced, and in accordance with a previous suggestion.
At claim 14, line 3, it is suggested that “an open anesthesia system” be replaced with “the open system” to differentiate from the anesthesia system that has already been introduced, and in accordance with a previous suggestion.
At claim 14, line 4, it is suggested that “the open state” be replaced with “an open state” as the limitation has not been introduced.
At claim 14, line 6, it is suggested that “an activation” be replaced with “the activation” as the limitation was introduced in line 4.
At claim 15, line 2, it is suggested that a hyphen be added between “non” and “transitory” to correct a grammatical error.
At claim 15, lines 4, it is suggested that “the processes steps” be replaced with “the steps” for clarity.
At claim 16, line 2, it is suggested that a comma be added following “breathing gases”.
At claim 16, lines 10-11, it is suggested that “the reservoir” be replaced with “the gas reservoir” for consistency with line 9.
At claim 17, line 2, it is suggested that a comma be added following “breathing gases”.
At claim 17, lines 10-11, it is suggested that “the reservoir” be replaced with “the gas reservoir” for consistency with line 9.
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.
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:
A/the “breathing connection element” in claims 1, 9, and 16-17. The term is interpreted relative to the instant specification at paragraph 26 to be an internal Y-piece, and functional equivalents thereof
A/the “patient connection element” in claims 1, 9, and 16-17. The term is interpreted relative to the instant specification at paragraph 36 to be a patient Y-piece, and functional equivalents thereof
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 § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 15 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 15, the limitation “at least some of the processes steps” in line 3 renders the claim indefinite. First, line 1 positively sets forth a process “in accordance with claim 9”, thus the additional recitation of “at least some of” the steps of the process of claim 9 makes it unclear which and how many of those steps must be carried out in order to read on the claim as drafted. As such, the metes and bounds of the claim are indeterminable.
It is suggested that “at least some of” be eliminated from the claim to overcome the rejection. Alternatively, the claim could be written in independent form with the set of required steps specifically detailed without reliance on the process of claim 9 to overcome the rejection.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 9-15 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception without significantly more.
Claim 9 is rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception without significantly more.
Step 1: Statutory Category
The claimed invention is directed to a method/process, and thus falls under one of the acceptable statutory categories (Step 1: YES).
Step 2, Prong 1: Judicial Exception
Claim 9 recites:
“with a measured value analysis, determining an operating state of the anesthesia system on the basis of the measured signals;” and
“wherein the determination is carried out to determine whether an operating state is present, in which certain partial quantities or quantities of carbon dioxide-containing and oxygen-depleted exhaled gases, which are exhaled by the patient, flow back to the patient.”
As presently drafted, these limitations (see “acquiring”, “determining”, and “to determine” steps) are process steps that, under their broadest reasonable interpretation, cover the performance of the limitations in the human mind since the limitations merely recite an analysis of measured signals from a plurality of sensors in determining an operating state of the anesthesia system, and whether there is backflow in the system. The human mind is capable of performing these steps as the mind is able to observe a quantitative measurement, qualitatively assess and analyze such a measurement, and then determine an operating state based on the measurement. At present, nothing in the claim precludes the steps from being performed in the mind and/or with the aid of pen and paper. As such, the claim recites a mental process-type abstract idea (Step 2A, Prong II: YES).
Step 2A, Prong II: Integration into a practical application
The claim recites the following additional elements:
a control unit; a radial compressor as a source for providing quantities of breathing gases; an internal closed-circuit system comprising: a carbon dioxide absorber; a breathing system connection element; an inspiratory path with an inspiratory nonreturn valve; and an expiratory path with an expiratory nonreturn valve; a flush valve assembly; a patient connection element; an adjustable pressure-limiting valve assembly; a breathing bag; and a mixing unit for the supply of fresh gas to the internal closed-circuit system, the process comprising the steps of:
acquiring a measured signal with a detection of measured signals of a first pressure sensor and of a first flow sensor;” and
“adapting an operation of the anesthesia system with control of the flush valve assembly as a function of the determined operating state in a sequence of steps”.
Reception of signals from the flow and pressure sensors is a data gathering step that is a form of insignificant pre-solution activity that does not integrate the judicial exception into an abstract idea. The step of “adapting” the operation of the system does note explicitly, as presently drafted, require any structural component of the anesthesia system to control the state of the flush valve. Rather, the claim merely recites that the operation of the system may be adapted “with control of the flush valve assembly”. Thus, the “adapting” step fails to integrate the judicial exception into a practical application because, on the basis of the acquisition, analysis, and determination steps, control of the flush valve assembly is not functionally or structurally linked to the anesthesia system as claimed.
Further, each of the control unit, radial compressor as a source for providing quantities of breathing gases, internal closed-circuit system comprising: a carbon dioxide absorber, a breathing system connection element, an inspiratory path with an inspiratory nonreturn valve, an expiratory path with an expiratory nonreturn valve, a flush valve assembly, a patient connection element, an adjustable pressure-limiting valve assembly, a breathing bag; and a mixing unit for the supply of fresh gas to the internal closed-circuit system are well-known, routine, and conventional elements for use in an anesthesia system (see Lampotang: anesthesia delivery system 10; controller 34; centrifugal blower 36; circulation loop 12; CO2 absorber 60; see Fig. 2, and the attaching tubes 137 and 184 at arrows 37 and towards purge valve 130 and enclosure 182 for the Y-piece breathing connection element; one-way inspiratory valve and one-way expiratory valve, and patient Y 14 for providing the inspiratory and expiratory branch paths; purge valve 130; patient Y 14; manual bag 92; see syringe pump 40 with tube 37 for mixing unit; note “flow/pressure monitor” and “pressure sensor” in the patient Y 14; Fig. 2 and Col. 2, lines 21-35, Col. 7, lines 3-21 and 43-45 Col. 8, lines 22-30, Col. 9, lines 22-25, Col. 10, lines 20-27; see Kopali: paragraph 27, lines 1-8 and Fig. 2 for APL valve 212 and its associated tubing). Thus, the use of these additional elements fails to integrate the abstract idea into a practical application because they are each generic and well-known in the art of anesthesia delivery devices, and do not serve to apply the abstract idea with or by use of a particular machine, effect a transformation, or apply/use the abstract idea in some other meaningful way beyond generally linking the use thereof to a particular technological environment to avoid monopolizing the exception (Step 2A, Prong II: NO).
Step 2B: Inventive Concept
As has been similarly outlined with respect to Step 2A, Prong II, the additional elements merely recite insignificant pre-solution activity, and/or fail to link the pre-solution activity into a practical application by specifically controlling a structure in the system to act on the flush valve based on the measured signals and the analysis thereof, neither of which amounts to significantly more than the abstract idea. In particular, the additional claim elements were shown to be well-known, routine, and conventional known in each of Lampotang and Kopali.Thus, the claim does not include an inventive concept and is ineligible (Step 2B: NO).
Each of claims 10-15 are rejected and ineligible at least by virtue of their dependence on claim 9.
Notably, claims 10-14 aim to further limit the steps outlined with respect to the rejection of claim 9, and thus incur rejections on the same basis as discussed with respect to the analysis of claim 9 under Step 2A Prong II.
This rejection may be overcome by amending to clarify that the process steps are configured to be carried out by the control unit of the system. In this case, the mental process-type abstract idea would be properly integrated into a practical application by making clear that controlling the flush valve operation is achieved explicitly by the control unit on the basis of the measured and analyzed signals.
Claim 15 is rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception without significantly more.
Step 1: Statutory Category
The claimed invention is directed to a method/process, and thus falls under one of the acceptable statutory categories (Step 1: YES).
Step 2, Prong 1: Judicial Exception
Claim 15 (by virtue of its dependence on claim 9) recites:
“with a measured value analysis, determining an operating state of the anesthesia system on the basis of the measured signals;” and
“wherein the determination is carried out to determine whether an operating state is present, in which certain partial quantities or quantities of carbon dioxide-containing and oxygen-depleted exhaled gases, which are exhaled by the patient, flow back to the patient.”
As presently drafted, these limitations (see “acquiring”, “determining”, and “to determine” steps) are process steps that, under their broadest reasonable interpretation, cover the performance of the limitations in the human mind since the limitations merely recite an analysis of measured signals from a plurality of sensors in determining an operating state of the anesthesia system, and whether there is backflow in the system. The human mind is capable of performing these steps as the mind is able to observe a quantitative measurement, qualitatively assess and analyze such a measurement, and then determine an operating state based on the measurement. At present, nothing in the claim precludes the steps from being performed in the mind and/or with the aid of pen and paper. As such, the claim recites a mental process-type abstract idea (Step 2A, Prong II: YES).
Step 2A, Prong II: Integration into a practical application
The claim recites the following additional elements (both in the body of claim 15 itself, and by virtue of its dependence on claim 9):
a control unit; a radial compressor as a source for providing quantities of breathing gases; an internal closed-circuit system comprising: a carbon dioxide absorber; a breathing system connection element; an inspiratory path with an inspiratory nonreturn valve; and an expiratory path with an expiratory nonreturn valve; a flush valve assembly; a patient connection element; an adjustable pressure-limiting valve assembly; a breathing bag; and a mixing unit for the supply of fresh gas to the internal closed-circuit system, the process comprising the steps of:
acquiring a measured signal with a detection of measured signals of a first pressure sensor and of a first flow sensor;” and
“adapting an operation of the anesthesia system with control of the flush valve assembly as a function of the determined operating state in a sequence of steps” and
“a non transitory computer readable media for carrying out at least some of the processes steps when the program code is executed on a computer, on a processor or on a programmable hardware component”.
Reception of signals from the flow and pressure sensors is a data gathering step that is a form of insignificant pre-solution activity that does not integrate the judicial exception into an abstract idea. The step of “adapting” the operation of the system does note explicitly, as presently drafted, require any structural component of the anesthesia system to control the state of the flush valve. Rather, the claim merely recites that the operation of the system may be adapted “with control of the flush valve assembly”. Thus, the “adapting” step fails to integrate the judicial exception into a practical application because, on the basis of the acquisition, analysis, and determination steps, control of the flush valve assembly is not functionally or structurally linked to the anesthesia system as claimed. Additionally, the use of a processor for carrying out program code with non-transitory media for the process steps fails to integrate the judicial exception into a practical application because it is merely used to perform the judicial exception.
Further, each of the control unit, radial compressor as a source for providing quantities of breathing gases, internal closed-circuit system comprising: a carbon dioxide absorber, a breathing system connection element, an inspiratory path with an inspiratory nonreturn valve, an expiratory path with an expiratory nonreturn valve, a flush valve assembly, a patient connection element, an adjustable pressure-limiting valve assembly, a breathing bag; a mixing unit for the supply of fresh gas to the internal closed-circuit system, and a computer program with code and non-transitory computer readable media executed on a computer, processor, or hardware component are well-known, routine, and conventional elements for use in an anesthesia system (see Lampotang: anesthesia delivery system 10; controller 34; centrifugal blower 36; circulation loop 12; CO2 absorber 60; see Fig. 2, and the attaching tubes 137 and 184 at arrows 37 and towards purge valve 130 and enclosure 182 for the Y-piece breathing connection element; one-way inspiratory valve and one-way expiratory valve, and patient Y 14 for providing the inspiratory and expiratory branch paths; purge valve 130; patient Y 14; manual bag 92; see syringe pump 40 with tube 37 for mixing unit; note “flow/pressure monitor” and “pressure sensor” in the patient Y 14; Fig. 2 and Col. 2, lines 21-35, Col. 7, lines 3-21 and 43-45 Col. 8, lines 22-30, Col. 9, lines 22-25, Col. 10, lines 20-27; see Kopali: paragraph 27, lines 1-8 and Fig. 2 for APL valve 212 and its associated tubing and paragraph 22, lines 1-8 for non-transitory media, stored code, and execution on a processor). Thus, the use of these additional elements fails to integrate the abstract idea into a practical application because they are each generic and well-known in the art of anesthesia delivery devices, and do not serve to apply the abstract idea with or by use of a particular machine, effect a transformation, or apply/use the abstract idea in some other meaningful way beyond generally linking the use thereof to a particular technological environment to avoid monopolizing the exception (Step 2A, Prong II: NO).
Step 2B: Inventive Concept
As has been similarly outlined with respect to Step 2A, Prong II, the additional elements merely recite insignificant pre-solution activity, and/or fail to link the pre-solution activity into a practical application by specifically controlling a structure in the system to act on the flush valve based on the measured signals and the analysis thereof, neither of which amounts to significantly more than the abstract idea. In particular, the additional claim elements were shown to be well-known, routine, and conventional known in each of Lampotang and Kopali.Thus, the claim does not include an inventive concept and is ineligible (Step 2B: NO).
As above, this rejection may be overcome by amending claim 9 to clarify that the process steps are configured to be carried out by the control unit of the system. In this case, the mental process-type abstract idea would be properly integrated into a practical application by making clear that controlling the flush valve operation is achieved explicitly by the control unit on the basis of the measured and analyzed signals.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or non-obviousness.
Claims 9 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Kapoli (US 2021/0322709) in view of Lampotang (US 6,131,571), Broberg (US 2015/0250960), and Jaffe (US 2005/0028817).
Regarding claim 9, Kopali discloses a process for operating an anesthesia device (100 in Fig. 1) with a pneumatic system (200 in Fig. 2) (paragraph 26, lines 1-4; paragraph 27, lines 1-16; Figs. 1-2), comprising:
a control unit (140 which includes 240) (paragraph 22, lines 1-10; paragraph 28, lines 6-8; Figs. 1-2);
a radial compressor as a source for providing quantities of breathing gases (paragraph 39, lines 16-22, see “compressor” which feeds oxygen);
an internal closed-circuit system (210; see Fig. 2 and paragraph 27, lines 12-13) comprising:
a carbon dioxide absorber (236) (paragraph 32, lines 1-10; Fig. 2);
a breathing system connection element (see annotated Fig. 2 below);
an inspiratory path (218) with an inspiratory nonreturn valve (220) (paragraph 29, lines 3-4; Fig. 2); and
an expiratory path (222) with an expiratory nonreturn valve (224) (paragraph 29, lines 4-5; Fig. 2);
a patient connection element (226 and the wye in Fig. 2 leading from paths 28 and 222 to 226) (paragraph 29, lines 1-5; Fig. 2);
an adjustable pressure-limiting valve assembly (212 and associated tubing) (paragraph 27, lines 6-8; Fig. 2);
a breathing bag (206) (paragraph 27, lines 6-8; Fig. 2); and
a mixing unit (114+228) for the supply of fresh gas to the internal closed-circuit system (210) (paragraph 32, lines 1-8; Figs. 1-2),
the process comprising the steps of:
acquiring a measured signal with a detection of measured signals of a first pressure sensor and of a first flow sensor (230) (paragraph 29, lines 1-7 and 14-21; paragraph 33, lines1-6);
with a measured value analysis, determining an operating state of the anesthesia system on the basis of the measured signals (paragraph 29, lines 1-7 and 14-21, where inhalation or exhalation, i.e. the instantaneous operating state, is determined as a result of the signals from the inhalation and exhalation sensor).
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Kopali fails to disclose:
a flush valve assembly;
adapting an operation of the anesthesia system with control of the flush valve assembly as a function of the determined operating state in a sequence of steps, and
wherein the determination is carried out to determine whether an operating state is present, in which certain partial quantities or quantities of carbon dioxide-containing and oxygen-depleted exhaled gases, which are exhaled by the patient, flow back to the patient.
However, Lampotang teaches an anesthesia delivery system (10) (Col. 7, lines 3-7; Fig. 2) which includes a flush valve assembly (130 and 137) connected to a scavenging system (150) for providing a pathway for discharging the gas mixture within the breathing circuit and to purge oxygen as desired, in order to change the concentration of gases within the breathing circuit (Col. 8, lines 34-38; Col. 14, lines 6-17; Fig. 2).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided a connection between the exhalation pathway of the Kapoli circuit and its scavenging system (see “to scavenge: in Kapoli’s Fig. 3), as taught by Lampotang, for providing a pathway for discharging the gas mixture within the exhalation pathway of the breathing circuit, and to purge oxygen/gas as desired in order to change the concentration of gases within the breathing circuit.
Modified Kapoli fails to disclose:
adapting an operation of the anesthesia system with control of the flush valve assembly as a function of the determined operating state in a sequence of steps, and
wherein the determination is carried out to determine whether an operating state is present, in which certain partial quantities or quantities of carbon dioxide-containing and oxygen-depleted exhaled gases, which are exhaled by the patient, flow back to the patient.
However, Broberg teaches adapting an operation of the anesthesia system with control of the flush valve assembly (37) as a function of the determined operating state in a sequence of steps in order to scrub the exhalant of anesthetic (paragraph 141, lines 1-16, where exhalation and its associated pressure drives the opening and closing of valve 37 to evacuation 42 following measurement by a pressure sensor and flow sensor, where exhalation is one of the operating states listed above; paragraph 147, lines 8-14).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method and device of modified Kopali to adapt an operation of the anesthesia system with control of the flush valve assembly as a function of the determined operating state in a sequence of steps, as taught by Broberg, in order to scrub anesthetic from exhaled gas as a result of exhalation being determined with associated pressure and flow sensors.
Further modified Kapoli fails to disclose:
wherein the determination is carried out to determine whether an operating state is present, in which certain partial quantities or quantities of carbon dioxide-containing and oxygen-depleted exhaled gases, which are exhaled by the patient, flow back to the patient.
However, Jaffe teaches wherein the determination is carried out to determine whether an operating state is present in which certain partial quantities or quantities of carbon dioxide-containing and oxygen-depleted exhaled gases, which are exhaled by the patient, flow back to the patient in order to determine if a valve in the breathing circuit is faulty (paragraph 42, lines 1-16, note sensing of either inspired carbon dioxide or end-tidal carbon dioxide to determine if a rebreathing valve 550 is faulty; given that the sensors operate in either inhalation or exhalation, the operating states identified above, Jaffe’s determination implicitly occurs following determination by a sensor of inhalation or exhalation phase).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of further modified Kapoli to include the provision that the determination is carried out to determine whether an operating state is present, in which certain partial quantities or quantities of carbon dioxide-containing and oxygen-depleted exhaled gases, which are exhaled by the patient, flow back to the patient, as taught by Jaffe, in order to determine if the flush valve is faulty and carries back carbon-dioxide containing gas to the patient.
Regarding claim 15, Kapoli in view of Lampotang, Broberg, and Jaffe disclose the process in accordance with claim 9, as discussed above.
Kapoli further discloses wherein a computer program with a program code provided with a non-transitory computer readable media for carrying out at least some of the processes steps when the program code is executed on a processor (paragraph 22, lines 1-10).
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Kapoli (US 2021/0322709) in view of Lampotang (US 6,131,571).
Regarding claim 16, Kopali discloses an assembly of components (100+200) for a pneumatic system (200 in Fig. 2) process for an anesthesia device (100 in Fig. 1) (paragraph 26, lines 1-4; paragraph 27, lines 1-16; Figs. 1-2), comprising:
an internal closed-circuit system (210; see Fig. 2 and paragraph 27, lines 12-13) comprising:
a carbon dioxide absorber (236) (paragraph 32, lines 1-10; Fig. 2);
a breathing system connection element (see connection of 228 and 234 in Fig. 2, forming a Y by virtue of the two branches off of 228 at 234);
an inspiratory path (218) with an inspiratory nonreturn valve (220) (paragraph 29, lines 3-4; Fig. 2); and
an expiratory path (222) with an expiratory nonreturn valve (224) (paragraph 29, lines 4-5; Fig. 2);
a patient connection element (226 and the wye in Fig. 2 leading from paths 28 and 222 to 226) connected to the internal closed-circuit system (210) (paragraph 29, lines 1-5; Fig. 2);
a gas reservoir (paragraph 17, lines 1-10, see “gas source(s)”);
a radial compressor as a source for providing quantities of breathing gases at the breathing system connection element (paragraph 39, lines 16-22, see “compressor” which feeds oxygen).
Kapoli fails to explicitly disclose a filter between the radial compressor and the breathing system connection element.
However, Lampotang teaches a filter (46) between the radial compressor (36) and the breathing system connection element (see branched circuit formed by tubes 37 and 14 downstream of the filter 46 in Fig. 2) for filtering bacteria out of the delivered gas before delivery to the patient (Col. 8, lines 24-27).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Kapoli to further include a filter between the radial compressor and the breathing system connection element, as taught by Lampotang, in order to filter bacteria out of the delivered gas before delivery to the patient.
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Kapoli (US 2021/0322709) in view of Rumph (US 2011/0056491).
Regarding claim 17, Kopali discloses an assembly of components (100+200) for a pneumatic system (200 in Fig. 2) process for an anesthesia device (100 in Fig. 1) (paragraph 26, lines 1-4; paragraph 27, lines 1-16; Figs. 1-2), comprising:
an internal closed-circuit system (210; see Fig. 2 and paragraph 27, lines 12-13) comprising:
a carbon dioxide absorber (236) (paragraph 32, lines 1-10; Fig. 2);
a breathing system connection element (see connection of 228 and 234 in Fig. 2, forming a Y by virtue of the two branches off of 228 at 234);
an inspiratory path (218) with an inspiratory nonreturn valve (220) (paragraph 29, lines 3-4; Fig. 2); and
an expiratory path (222) with an expiratory nonreturn valve (224) (paragraph 29, lines 4-5; Fig. 2);
a patient connection element (226 and the wye in Fig. 2 leading from paths 28 and 222 to 226) connected to the internal closed-circuit system (210) (paragraph 29, lines 1-5; Fig. 2);
a gas reservoir (paragraph 17, lines 1-10, see “gas source(s)”);
a radial compressor as a source for providing quantities of breathing gases at the breathing system connection element (paragraph 39, lines 16-22, see “compressor” which feeds oxygen);
a flush branch (214) leading from the internal closed-circuit system (210) (paragraph 27, lines 17-20; Fig. 2)
a flush valve (212) in the flush branch (214) (paragraph 27, lines 17-20; Fig. 2).
Kapoli fails to explicitly disclose a filter in the flush branch.
However, Rumph teaches a filter in the flush branch in order to scrub exhaled anesthesia from the exhaled gas (paragraph 40, lines 14-20, where the passage including pop-off/bleed valve 30 is the flush branch, note “charcoal filter”; Fig. 4).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Kapoli to further include a filter in the flush branch, as taught by Rumph, in order to scrub exhaled anesthesia from the exhaled gas.
Allowable Subject Matter
Claims 1-8 would be allowed if amended to address each outstanding formal matter outlined with respect to the claim objection section of the Office action.
Claims 10-14 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims. Further, the rejection under 35 USC 101 to include claims 9-15 would need to be successfully overcome in order for claim 9 to be passed towards allowance.
The following is a statement of reasons for the indication of allowable subject matter:
Regarding claim 1, the closest identified prior art of record is Kopali (US 2021/0322709), Lampotang (US 6,131,571), and Pasadilla (US 2024/0285885).
As addressed in-part above, Kopali discloses n assembly of components (100+200) for a pneumatic system (200 in Fig. 2) process for an anesthesia device (100 in Fig. 1) (paragraph 26, lines 1-4; paragraph 27, lines 1-16; Figs. 1-2), comprising:
a control unit (140 which includes 240) (paragraph 22, lines 1-10; paragraph 28, lines 6-8; Figs. 1-2);
a radial compressor as a source for providing quantities of breathing gases (paragraph 39, lines 16-22, see “compressor” which feeds oxygen);
an internal closed-circuit system (210; see Fig. 2 and paragraph 27, lines 12-13) comprising:
a carbon dioxide absorber (236) (paragraph 32, lines 1-10; Fig. 2);
a breathing system connection element (see annotated Fig. 2 below);
an inspiratory path (218) with an inspiratory nonreturn valve (220) (paragraph 29, lines 3-4; Fig. 2); and
an expiratory path (222) with an expiratory nonreturn valve (224) (paragraph 29, lines 4-5; Fig. 2);
a patient connection element (226 and the wye in Fig. 2 leading from paths 28 and 222 to 226) (paragraph 29, lines 1-5; Fig. 2);
an adjustable pressure-limiting valve assembly (212 and associated tubing) (paragraph 27, lines 6-8; Fig. 2);
a breathing bag (206) (paragraph 27, lines 6-8; Fig. 2); and
a mixing unit (114+228) for the supply of fresh gas to the internal closed-circuit system (210) (paragraph 32, lines 1-8; Figs. 1-2); and
a first flow sensor, wherein the first flow sensor is configured to detect and to provide measured signals, which indicate a flow rate flowing in the internal closed-circuit system (210), to the control unit (140) (paragraph 29, lines 1-7 and 14-21, see either inspiratory or expiratory flow sensors).
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Kopali fails to disclose:
a flush valve assembly; and
wherein the control unit is configured to determine a current tidal volume on the basis of the measured signals, which indicate a flow rate flowing in the internal closed-circuit system, and wherein the control unit is configured to bring about a state of change of the flush valve assembly on the basis of the current, determined tidal volume.
However, Lampotang teaches an anesthesia delivery system (10) (Col. 7, lines 3-7; Fig. 2) which includes a flush valve assembly (130 and 137) connected to a scavenging system (150) for providing a pathway for discharging the gas mixture within the breathing circuit and to purge oxygen as desired, in order to change the concentration of gases within the breathing circuit (Col. 8, lines 34-38; Col. 14, lines 6-17; Fig. 2).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided a connection between the exhalation pathway of the Kapoli circuit and its scavenging system (see “to scavenge: in Kapoli’s Fig. 3), as taught by Lampotang, for providing a pathway for discharging the gas mixture within the exhalation pathway of the breathing circuit, and to purge oxygen/gas as desired in order to change the concentration of gases within the breathing circuit.
Presently modified Kapoli still fails to disclose wherein the control unit is configured to determine a current tidal volume on the basis of the measured signals, which indicate a flow rate flowing in the internal closed-circuit system, and wherein the control unit is configured to bring about a state of change of the flush valve assembly on the basis of the current, determined tidal volume.
With respect to this limitation, Pasadilla supplies the closest teaching. Pasadilla indicates a rebreather for a SCBA system wherein the control unit (“controller”) is configured to determine a current volume on the basis of the measured signals (singlas from sensor assembly 630), and wherein the control unit is configured to bring about a state of change of the flush valve assembly (650) on the basis of the current, determined volume (paragraph 56, lines 7-17, see “volume”).
Notably, Pasadilla does not explicitly contemplate use of a tidal volume, nor does Pasadilla explicitly refer to a measured flow rate. Further though, it would not be considered prima facie obvious to combine the control architecture of Pasadilla SCBA rebreather with the scavenging architecture in Kapoli. This is because Pasadilla device singularly controls the feeding of oxygen into the system (600), whereas Kapoli’s device accounts for delivery of a mixture of breathing gases which includes oxygen as well as anesthetic agent. Therefore, the underlying calculation/schemes for controlling the analogous flush valves would reasonably be different enough because of the diverging fields of use of either device/system, such that the ordinarily skilled artisan would not reasonably look to Pasadilla’s simplified control scheme containing delivery of only oxygen, to modify the control scheme of the more complicated gas delivery in Kapoli’s system.
With respect to claims 10-14, the closest identified prior art of record are those references employed in the 103 rejection against claim 9. None of the cited documents contemplate signal analysis and flush valve control on the basis of tidal volume. Each of claims 10-14, either by virtue of dependency or in the body of the claim itself, requires use of tidal volume measurements for various control schemes employed in the process.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Burgess (US 2024/0261523) is cited for its anesthetic delivery system with rebreathing components as shown diagrammatically in Figure 1.
Brown (US 2023/0310778) is cited for its anesthetic delivery system with rebreathing components as shown diagrammatically in Figure 1.
Homuth (US 2021/0244899) is cited for its anesthetic delivery system with rebreathing components as shown diagrammatically in Figure 1.
McCormick (US 2020/0353200) is cited for its anesthetic delivery system with rebreathing components as shown diagrammatically in Figure 1.
Modi (US 2020/0306472) is cited for its anesthetic delivery system with rebreathing components as shown diagrammatically in Figures 1 and 2.
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/PAIGE KATHLEEN BUGG/Primary Examiner, Art Unit 3785
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