DETAILED ACTION
This Office Action is in response to the claims filed on 08/16/2022.
Claims 1-20 are pending.
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 .
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in parent Application No. DE102021004375, filed on 08/26/2021.
Examiner Notes
Examiner cites particular columns, paragraphs, figures and line numbers in the
references as applied to the claims below for the convenience of the applicant. Although
the specified citations are representative of the teachings in the art and are applied to
the specific limitations within the individual claim, other passages and figures may apply
as well. It is respectfully requested that, in preparing responses, the applicant fully
consider the references in their entirety as potentially teaching all or part of the claimed
invention, as well as the context of the passage as taught by the prior art or disclosed
by the examiner. The entire reference is considered to provide disclosure relating to the
claimed invention. The claims & only the claims form the metes & bounds of the
invention. Office personnel are to give the claims their broadest reasonable
interpretation in light of the supporting disclosure. Unclaimed limitations appearing in the
specification are not read into the claim. Prior art was referenced using terminology
familiar to one of ordinary skill in the art. Such an approach is broad in concept and can
be either explicit or implicit in meaning. Examiner's Notes are provided with the cited
references to assist the applicant to better understand how the examiner interprets the
applied prior art. Such comments are entirely consistent with the intent & spirit of
compact prosecution.
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 06/13/2023 was filed in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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:
“the control module being configured and designed [...] to” in claim 1,
“a simulation unit, which is configured and designed to” in claim 2,
“the expiration unit being configured to” and “the inspiration unit being configured to” in claim 4,
“the gas module is designed and configured to” in claim 6,
“the inspiration unit is configured and designed to” in claim 10,
“the expiration unit being configured and designed to” in claim 11,
“an evaluation unit which is configured and designed to” in claim 14,
“the input unit is configured and designed to” in claim 17.
Because these claim limitations are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, they 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 these limitations 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 § 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 1-20 are rejected under 35 U.S.C. 101 because the claimed invention recites a judicial exception, is directed to that judicial exception (an abstract idea), as it has not been integrated into a practical application and the claim(s) further do/does not recite significantly more than the judicial exception. Examiner has evaluated the claim(s) under the framework provided in MPEP 2106 and has provided such analysis below.
To determine if a claim is directed to patent ineligible subject matter, the Court
has guided the Office to apply the Alice/Mayo test, which requires:
Step 1. Determining if the claim falls within a statutory category of a Process, Machine, Manufacture, or a Composition of Matter (see MPEP 2106.03);
Step 2A. Determining if the claim is directed to a patent ineligible judicial exception consisting of a law of nature, a natural phenomenon, or abstract idea (MPEP 2106.04);
Step 2A is a two-prong inquiry. MPEP 2106.04(II)(A).
Under the first prong, examiners evaluate whether a law of nature, natural phenomenon, or abstract idea is set forth or described in the claim. Abstract ideas include mathematical concepts, certain methods of organizing human activity, and mental processes. MPEP 2106.04(a)(2).
The second prong is an inquiry into whether the claim integrates a judicial exception into a practical application. MPEP 2106.04(d).
Step 2B. If the claim is directed to a judicial exception, determining if the claim recites limitations or elements that amount to significantly more than the judicial exception. (See MPEP 2106).
Step 1:
Claims 1-19 are directed to a system, as such these claims fall within the statutory category of a machine.
Claim 20 is directed to a method, as such these claims fall within the statutory category of process.
Step 2A, Prong 1:
The examiner submits that the foregoing claim limitations constitute abstract ideas, as the claims cover Mathematical Concepts, given the broadest reasonable interpretation.
In order to apply Step 2A, a recitation of claims is copied below. The limitations of those claims which describe an abstract idea are bolded.
As per claim 1, the claim recites the limitations of:
the control module being configured and designed, in a first simulation
part, to mathematically simulate a breathing of a living being (As drafted and under its broadest reasonable interpretation, this limitation amounts to Mathematical Concepts per MPEP 2106.04(a)(2)(I). The mathematical concepts grouping is defined as mathematical relationships, mathematical formulas or equations, and mathematical calculations. A mathematical relationship is a relationship between variables or numbers. A mathematical relationship may be expressed in words or using mathematical symbols. A claim that recites a mathematical calculation, when the claim is given its broadest reasonable interpretation in light of the specification, will be considered as falling within the "mathematical concepts" grouping.)
Step 2A, Prong 2:
As per claim 1, this judicial exception is not integrated into a practical application because the additional claim limitations outside the abstract idea only present Mere Instructions To Apply An Exception. In particular, the claim recites the additional limitations:
the control module being configured and designed, in a second simulation part, to control the gas module on the basis of the mathematical simulation from the first simulation part. (The additional element amounts to Mere Instructions to Apply an Exception per MPEP 2106.05(f). Specifically, this limitation is directed towards mere instructions to implement an abstract idea (i.e. mathematical concepts) on a computer.)
Accordingly, these additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea when considered as an ordered combination and as a whole.
Step 2B:
For step 2B of the analysis, the Examiner must consider whether each claim limitation individually or as an ordered combination amounts to significantly more than the abstract idea. This analysis includes determining whether an inventive concept is furnished by an element or a combination of elements that are beyond the judicial exception. For limitations that were categorized as “apply it” or generally linking the use of the abstract idea to a particular technological environment or field of use, the analysis is the same.
The additional elements as described in Step 2A Prong 2 are not sufficient to amount to significantly more than the judicial exception because the additional limitations are considered directed towards Mere Instructions To Apply An Exception. See MPEP 2106.04(d) referencing MPEP 2106.05(d)/(f)].
Per MPEP 2106.05(d)(II), the courts have recognized the following computer functions as well‐understood, routine, and conventional functions when they are claimed in a merely generic manner (e.g., at a high level of generality) or as insignificant extra-solution activity: i. Receiving or transmitting data over a network, ii. Performing repetitive calculations, iii. Electronic recordkeeping, iv. Storing and retrieving information in memory.
For the foregoing reasons, claim 1 is directed to an abstract idea without significantly more and is rejected as not patent eligible under 35 U.S.C. 101.
Step 2A, Prong 1 (Claim 20):
The examiner submits that the foregoing claim limitations constitute abstract ideas, as the claims cover Mathematical Concepts, given the broadest reasonable interpretation.
In order to apply Step 2A, a recitation of claims is copied below. The limitations of those claims which describe an abstract idea are bolded.
As per independent claim 20, the claim recites the limitations of:
wherein the breathing of the living being is simulated in a first simulation part by a mathematical simulation (As drafted and under its broadest reasonable interpretation, this limitation amounts to Mathematical Concepts per MPEP 2106.04(a)(2)(I). The mathematical concepts grouping is defined as mathematical relationships, mathematical formulas or equations, and mathematical calculations. A mathematical relationship is a relationship between variables or numbers. A mathematical relationship may be expressed in words or using mathematical symbols. A claim that recites a mathematical calculation, when the claim is given its broadest reasonable interpretation in light of the specification, will be considered as falling within the "mathematical concepts" grouping.)
Step 2A, Prong 2 (Claim 20):
As per independent claim 20, this judicial exception is not integrated into a practical application because the additional claim limitations outside the abstract idea only present Mere Instructions To Apply An Exception. In particular, the claim recites the additional limitations:
in a second simulation part, a gas module is controlled on the basis of the mathematical simulation (The additional element amounts to Mere Instructions to Apply an Exception per MPEP 2106.05(f). Specifically, this limitation is directed towards mere instructions to implement an abstract idea (i.e. mathematical concepts) on a computer.)
Accordingly, these additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea when considered as an ordered combination and as a whole.
Step 2B (Claim 20):
For step 2B of the analysis, the Examiner must consider whether each claim limitation individually or as an ordered combination amounts to significantly more than the abstract idea. This analysis includes determining whether an inventive concept is furnished by an element or a combination of elements that are beyond the judicial exception. For limitations that were categorized as “apply it” or generally linking the use of the abstract idea to a particular technological environment or field of use, the analysis is the same.
The additional elements as described in Step 2A Prong 2 are not sufficient to amount to significantly more than the judicial exception because the additional limitations are considered directed towards Mere Instructions To Apply An Exception. See MPEP 2106.04(d) referencing MPEP 2106.05(d)/(f).
Per MPEP 2106.05(d)(II), the courts have recognized the following computer functions as well‐understood, routine, and conventional functions when they are claimed in a merely generic manner (e.g., at a high level of generality) or as insignificant extra-solution activity: i. Receiving or transmitting data over a network, ii. Performing repetitive calculations, iii. Electronic recordkeeping, iv. Storing and retrieving information in memory.
For the foregoing reasons, claim 20 is directed to an abstract idea without significantly more and is rejected as not patent eligible under 35 U.S.C. 101.
Claim 2 recites wherein the control module comprises a simulation unit, which is configured and designed to mathematically simulate the breathing of a living being. The additional element further recites Mathematical Concepts per MPEP 2106.04(a)(2)(I). Therefore, the claim is rejected as not patent eligible under 35 U.S.C. 101.
Claim 3 recites wherein the control module is configured and designed to control the gas module such that in the second simulation part the mathematical simulation of the first simulation part is converted into a physical simulation of the breathing of a living being. The additional element amounts to Mere Instructions to Apply an Exception per MPEP 2106.05(f). Specifically, this limitation recites only the idea of a solution or outcome i.e., the claim fails to recite details of how a solution to a problem is accomplished. Therefore, the claim is rejected as not patent eligible under 35 U.S.C. 101.
Claim 4 recites wherein the gas module comprises at least one expiration unit and at least one inspiration unit, the expiration unit being configured to simulate an expiration of a living being, and the inspiration unit being configured to simulate an inspiration of a living being. The additional element amounts to Mere Instructions to Apply an Exception per MPEP 2106.05(f). Specifically, this limitation recites only the idea of a solution or outcome i.e., the claim fails to recite details of how a solution to a problem is accomplished. Therefore, the claim is rejected as not patent eligible under 35 U.S.C. 101.
Claim 5, the system of claim 2, recites wherein the simulation unit is designed to calculate and/or simulate a pressure which is generated by the simulated living being in lungs. The additional element further recites Mathematical Concepts per MPEP 2106.04(a)(2)(I) and/or Mere Instructions to Apply an Exception per MPEP 2106.05(f). Therefore, the claim is rejected as not patent eligible under 35 U.S.C. 101.
Claim 6 recites wherein the gas module is designed and configured to physically simulate the pressure which is generated by the simulated living being in lungs. The additional element amounts to Mere Instructions to Apply an Exception per MPEP 2106.05(f). Specifically, this limitation recites only the idea of a solution or outcome i.e., the claim fails to recite details of how a solution to a problem is accomplished. Therefore, the claim is rejected as not patent eligible under 35 U.S.C. 101.
Claim 7 recites wherein the gas module is connectable via a port to a ventilator. The additional element simply elaborates on the gas module and thus further amounts to Mere Instructions to Apply an Exception per MPEP 2106.05(f). Therefore, the claim is rejected as not patent eligible under 35 U.S.C. 101.
Claim 8, the system of claim 4, recites wherein the expiration unit comprises at least one gas source and/or at least one fan. The additional limitation generally links the use of a judicial exception to a particular technological environment or field of use, thus is directed towards Field of Use and Technological Environment per MPEP 2106.05(h). Therefore, the claim is rejected as not patent eligible under 35 U.S.C. 101.
Claim 9 recites wherein a mathematically simulated respiratory flow is physically simulated by at least one fan, and a simulated gas composition is achieved by at least one gas source. The additional element recites only the idea of a solution or outcome i.e., the claim fails to recite details of how a solution to a problem is accomplished, thus amounts to Mere Instructions to Apply an Exception per MPEP 2106.05(f). Therefore, the claim is rejected as not patent eligible under 35 U.S.C. 101.
Claim 10, the system of claim 4, recites wherein the inspiration unit is configured and designed to generate an underpressure. The additional element recites only the idea of a solution or outcome i.e., the claim fails to recite details of how a solution to a problem is accomplished, thus amounts to Mere Instructions to Apply an Exception per MPEP 2106.05(f). Therefore, the claim is rejected as not patent eligible under 35 U.S.C. 101.
Claim 11, the system of claim 4, recites wherein the expiration unit comprises a plurality of gas sources, the expiration unit being configured and designed to make available, on the basis of the mathematical simulation, a gas mixture which corresponds to a gas composition of exhaled air of a living being. The additional element recites only the idea of a solution or outcome i.e., the claim fails to recite details of how a solution to a problem is accomplished, thus amounts to Mere Instructions to Apply an Exception per MPEP 2106.05(f). Therefore, the claim is rejected as not patent eligible under 35 U.S.C. 101.
Claim 12 recites wherein a fan is arranged in the gas module, the fan serving both as expiration unit and as inspiration unit by a switching of valves and bypass lines arranged in the gas module. The additional element recites only the idea of a solution or outcome i.e., the claim fails to recite details of how a fan serves as both expiration/inspiration by a switching of valves/bypass lines, thus amounts to Mere Instructions to Apply an Exception per MPEP 2106.05(f). Therefore, the claim is rejected as not patent eligible under 35 U.S.C. 101.
Claim 13 recites wherein the system further comprises a sensor arrangement which is configured and designed to detect values of the breathing. The additional element recites only the idea of a solution or outcome i.e., the claim fails to recite details of how a solution to a problem is accomplished, thus amounts to Mere Instructions to Apply an Exception per MPEP 2106.05(f). Therefore, the claim is rejected as not patent eligible under 35 U.S.C. 101.
Claim 14, the system of claim 13, recites wherein the control module is configured and designed to incorporate values detected via the sensor arrangement into the mathematical simulation, (The additional element amounts to Insignificant Extra-Solution Activity (mere data gathering) per MPEP 2106.05(g). The term "extra-solution activity" can be understood as activities incidental to the primary process or product that are merely a nominal or tangential addition to the claim. Extra-solution activity includes both pre-solution and post-solution activity. An example of pre-solution activity is a step of gathering data for use in a claimed process.)
the control module comprising an evaluation unit which is configured and designed to evaluate and/or analyze the values detected via the sensor arrangement. (The additional element recites Mental Processes (MPEP 2106.04(a)(2)(III)) performed on a computer, which are defined as concepts that can practically be performed in the human mind (e.g. observations, evaluations, judgments, opinions), or by a human using pen and paper as a physical aid. For instance, a person can reasonably evaluate/analyze with/without the aid of pen and paper.)
Therefore, the claim is rejected as not patent eligible under 35 U.S.C. 101.
Claim 15, the system of claim 14, recites wherein the evaluation unit is configured and designed to analyze the values detected via the sensor arrangement in order to ascertain whether the mathematical simulation is correctly implemented by the gas module. The additional element elaborates on the sensor values to be analyzed, therefore further amounts to Mental Processes (MPEP 2106.04(a)(2)(III)) performed on a computer. Therefore, the claim is rejected as not patent eligible under 35 U.S.C. 101.
Claim 16 recites wherein the system further comprises an input unit via which data, values and/or information are input, the data, values and/or information serving at least in part as specifications for the mathematical simulation. (The additional element amounts to Insignificant Extra-Solution Activity (mere data gathering) per MPEP 2106.05(g). Per MPEP 2106.05(d)(II), the courts have recognized the following computer functions as well‐understood, routine, and conventional functions when they are claimed in a merely generic manner (e.g., at a high level of generality) or as insignificant extra-solution activity: i. Receiving or transmitting data over a network, ii. Performing repetitive calculations, iii. Electronic recordkeeping, iv. Storing and retrieving information in memory. Therefore, the claim is rejected as not patent eligible under 35 U.S.C. 101.
Claim 17, the system of claim 16, recites wherein the input unit is configured and designed to input values and/or data and/or information from an evaluation unit into a simulation unit. The additional element elaborates on the input unit, thus further amounts to Insignificant Extra-Solution Activity (mere data gathering) per MPEP 2106.05(g). Per MPEP 2106.05(d)(II), the courts have recognized the following computer functions as well‐understood, routine, and conventional functions when they are claimed in a merely generic manner (e.g., at a high level of generality) or as insignificant extra-solution activity: i. Receiving or transmitting data over a network, ii. Performing repetitive calculations, iii. Electronic recordkeeping, iv. Storing and retrieving information in memory. Therefore, the claim is rejected as not patent eligible under 35 U.S.C. 101.
Claim 18 recites wherein the system further comprises a respiratory gas humidifier and/or a respiratory gas heater. The additional elements further elaborates on the gas module, thus further amounts to Mere Instructions to Apply an Exception per MPEP 2106.05(f). Therefore, the claim is rejected as not patent eligible under 35 U.S.C. 101.
Claim 19 recites wherein the control module is configured and designed to at least partially control a ventilator on the basis of the mathematical simulation, the ventilator being connected to a real person. The additional elements further elaborates on the control module, thus further amounts to Mere Instructions to Apply an Exception per MPEP 2106.05(f). Therefore, the claim is rejected as not patent eligible under 35 U.S.C. 101.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-6, 8, 10-11, 13-17, and 20 are rejected under 35 U.S.C. 102(a)(1) / (a)(2) as being anticipated by Lampotang et al. US Patent No. 5584701 (hereinafter referred to as “Lampotang”).
Regarding claim 1, Lampotang discloses A system for simulating the breathing of a living being (“The present invention discloses a self-regulated lung in a manikin for use in real time in an integrated patient simulator during simulated medical procedures” Lampotang [Col.5 Ln.25-27]), wherein the system comprises at least a gas module and a control module, the control module being configured and designed, in a first simulation part, to mathematically simulate a breathing of a living being , and, in a second simulation part, to control the gas module on the basis of the mathematical simulation from the first simulation part. (“the patient simulator disclosed herein contains a hybrid (mechanical and mathematical) lung model which regulates itself regardless of what type of gas (air, anesthetics, hypoxic, etc.) is inhaled. In addition, even the blunting of physiological control mechanisms (e.g., ventilatory response to carbon dioxide) is self-regulated“ Lampotang [Col.13 Ln.15-21], “Module 34 is responsible for portions of the lung simulator: the gas exchange and mass flow controllers 122 [...] module 44 drives other portions of the lung simulator: the lung mechanics 26 and the two EPRs 108 (See FIG. 2)” Lampotang [Col.14 Ln.21-32])
Regarding claim 2, Lampotang discloses wherein the control module comprises a simulation unit, which is configured and designed to mathematically simulate the breathing of a living being. (“The lung model portion of the patient simulator is capable of simulating spontaneous breathing” Lampotang [Col.12 Ln.8], “the patient simulator disclosed herein contains a hybrid (mechanical and mathematical) lung model which regulates itself regardless of what type of gas (air, anesthetics, hypoxic, etc.) is inhaled.” Lampotang [Col.13 Ln.15-18])
Regarding claim 3, Lampotang discloses wherein the control module is configured and designed to control the gas module such that in the second simulation part the mathematical simulation of the first simulation part is converted into a physical simulation of the breathing of a living being. (“The present invention discloses a self-regulated lung [...] comprising at least one bellows capable of receiving and expelling a gas, a means for actuating the bellows between expanded and contracted states depending upon a time- and event-based script, a computer model or a combination of a time- and event-based script and a computer model based on the physiological state of the patient simulator (i.e. mathematical simulation), at least one mass flow controller capable of directing the gas into the bellows when the bellows expands in volume” Lampotang [Col.5 Ln.27-35])
Regarding claim 4, Lampotang discloses wherein the gas module comprises at least one expiration unit and at least one inspiration unit, the expiration unit being configured to simulate an expiration of a living being, and the inspiration unit being configured to simulate an inspiration of a living being. (“Spontaneous movement of the bellows is driven by an analog muscle pressure signal to simulate inspiration, active expiration, coughing, and different spontaneous breathing patterns (I/E [inhalation/exhalation] ratio” Lampotang [Col.12 Ln.10-14])
Regarding claim 5, the system of claim 2, Lampotang discloses wherein the simulation unit is designed to calculate and/or simulate a pressure which is generated by the simulated living being in lungs. (“The lung model portion of the patient simulator is capable of simulating spontaneous breathing with computer control of tidal volume (VT) and respiratory rate (RR). Spontaneous movement of the bellows is driven by an analog muscle pressure signal to simulate inspiration, active expiration, coughing, and different spontaneous breathing patterns (I/E [inhalation/exhalation] ratio” Lampotang [Col.12 Ln.8-14])
Regarding claim 6, Lampotang discloses wherein the gas module is designed and configured to physically simulate the pressure which is generated by the simulated living being in lungs. (“The muscle pressure signal is generated by the physiologic control model based on arterial blood O2 and CO2 content. The signal is converted by a digital to analog converter into a physical signal directed to the electronic pressure regulators (EPRs).” Lampotang [Col.12 Ln.19-23])
Regarding claim 8, the system of claim 4, Lampotang discloses wherein the expiration unit comprises at least one gas source and/or at least one fan. (“The gas 308 is used to simulate the flow of gases coming from the trachea during inhalation. In addition, the bronchial resistance means allows for the gas to travel in the opposite direction, from the lung 26 to the trachea as in expiration.” Lampotang [Col.21 Ln. 46-50])
Regarding claim 10, the system of claim 4, Lampotang discloses wherein the inspiration unit is configured and designed to generate an underpressure. (“Movement of the top plate 120 in an upward direction increases the volume of the bellows 100. This increased volume creates a slight sub ambient pressure (i.e. underpressure) in the bellows 100, thereby mimicking inhalation or inspiration.” Lampotang [Col.18 Ln.55-58])
Regarding claim 11, the system of claim 4, Lampotang discloses wherein the expiration unit comprises a plurality of gas sources, (“Uptake and delivery of the alveolar gases inside the bellows 100 are physically created by gas substitution. The gases presently contemplated are O2, CO2, N2, N2O” Lampotang [Col.17 Ln.14-16])
the expiration unit being configured and designed to make available, on the basis of the mathematical simulation, a gas mixture which corresponds to a gas composition of exhaled air of a living being. (“when a user changes the inspired gas composition, this change causes changes to the physically simulated alveolar concentrations of the various gases. The physiological model will then determine the effects of these changes in gas concentrations in the lung [...] The lung model physically simulates these changes [...] the lung model changes result in a different composition of gas being exhaled” Lampotang [Col.13 Ln.25-34])
Regarding claim 13, Lampotang discloses wherein the system further comprises a sensor arrangement which is configured and designed to detect values of the breathing. (“Another preferred embodiment comprises the use of intrapleural pressure sensors 101 situated inside the bellows 100. These devices determine the pressure of the bellows which data form a part of the physiological state of the patient simulator 1” Lampotang [Col.19 Ln.29-32])
Regarding claim 14, the system of claim 13, Lampotang discloses wherein the control module is configured and designed to incorporate values detected via the sensor arrangement into the mathematical simulation, (“ The pressure inside the bellows 100 is under continuous monitoring based on the output from a pressure sensor 101. This pressure output is used as one of the inputs to the physiological model coordinated by the computer 16” Lampotang [Col.18 Ln.15-19])
the control module comprising an evaluation unit which is configured and designed to evaluate and/or analyze the values detected via the sensor arrangement (“Before expulsion through the vane pump 106, gases transferred to the conduit 104 are analyzed in a gas analyzer 48 which is situated intermediate the vane pump and the bellows” Lampotang [Col.18 Ln.22-25])
Regarding claim 15, the system of claim 14, Lampotang discloses wherein the evaluation unit is configured and designed to analyze the values detected via the sensor arrangement in order to ascertain whether the mathematical simulation is correctly implemented by the gas module. (“Finally, a gas analyzer 48 may be disposed along the second conduit 104 intermediate the bellows 100 and the vane pump 106, wherein the gas analyzer 48 is capable of assaying the expelled gases. The information on expelled gases is then transmitted via an electric signal (not shown) to the computer 16. In the computer, based upon the current physiological (i.e. mathematical) model and physiological state, a simulated response to the gas analysis is computed. For instance, if no carbon dioxide is being expelled by the modeled lung 26, then an abnormal condition may be deduced in the physiological state.” Lampotang [Col.19 Ln.50-60])
Regarding claim 16, Lampotang discloses wherein the system further comprises an input unit via which data, values and/or information are input, the data, values and/or information serving at least in part as specifications for the mathematical simulation. (“Also included is a unique way of linking the different subsystems to realistically simulate the interactions between the subsystems and the control system in response to the actions of a trainee, student, or other user (including input from both a computer peripheral such as a mouse/keyboard, wired remote keypad, wireless remote control unit, barcode reader and from sensors physically embedded in the full scale lung/patient simulator).” Lampotang [Col.11 Ln.49-56])
Regarding claim 17, the system of claim 16, Lampotang discloses wherein the input unit is configured and designed to input values and/or data and/or information from an evaluation unit into a simulation unit. (“the gas analyzer (i.e. evaluation unit) 48 is capable of assaying the expelled gases. The information on expelled gases is then transmitted via an electric signal (not shown) to the computer 16. In the computer, based upon the current physiological model and physiological state, a simulated response to the gas analysis is computed.” Lampotang [Col.19 Ln.52-57])
Regarding claim 20, Lampotang discloses A method for simulating the breathing of a living being, wherein the breathing of the living being is simulated in a first simulation part by a mathematical simulation and, in a second simulation part, a gas module is controlled on the basis of the mathematical simulation. (“there is a method of simulating a self-regulated lung in real time in an integrated patient simulator [...] comprising the steps of expanding in volume at least one bellows by a bellows actuating means, directing to the bellows a gas flow delivered by at least one mass flow controller [...] a preferred embodiment uses a bellows actuating means [...] to simulate, expand or contract depending upon a time- and event-based script, a computer model or a combination of a time- and event-based script and a computer model based on the physiological state of the patient simulator” Lampotang [Col.8 Ln.31-53]. The patient simulator is interpreted as a mathematical simulation because “the patient simulator disclosed herein contains a hybrid (mechanical and mathematical) lung model” Lampotang [Col.13 Ln.15-17]))
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.
Claims 7, 9, and 18-19 are rejected under 35 U.S.C. 103 as being unpatentable over Lampotang et al. US Patent No. 5584701 (hereinafter referred to as “Lampotang”), in view of Glasgow et al. US Pub. No. 2024/0304111 A1 (provisional application filed Jun 15, 2021) (hereinafter referred to as “Glasgow”).
Regarding claim 7, Lampotang fails to specifically disclose the limitations of claim 7, however, analogous art of Glasgow discloses wherein the gas module is connectable via a port to a ventilator. (“The flow source (i.e. gas module) 50 is shown as part of the apparatus 10. However, in the case of an external oxygen tank or in-wall source, the flow source 50 may be considered a separate component, in which case the apparatus 10 has a connection port to connect to such flow source (i.e. gas module). The flow source can provide a flow of gases that can be delivered to a patient via a delivery conduit 16” Glasgow [P.0088])
Lampotang and Glasgow area analogous art as both address the simulation of respiratory function for training or educational purposes. Each enables the emulation of patient responses to respiratory therapy, and both can be integrated with auxiliary devices (e.g., pulse oximeters, gas analyzers). Both systems allow for modification of simulation parameters to reflect different patient states or therapy conditions. 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 Lampotang’s self-regulating lung system to include a gas module connecting port should one require “an in-wall supply of oxygen, a tank of oxygen, or a tank of other gas” Glasgow [P.0088].
Regarding claim 9, Lampotang discloses ,
and a simulated gas composition is achieved by at least one gas source. (“a constant [a]mount of gas is removed from the lung and its composition analyzed in real time by a gas analyzer 48. For each gas, uptake and delivery is modeled by permitting an appropriate inflow of that gas” Lampotang [Col.30 Ln.9-13])
Lampotang fails to specifically disclose wherein a mathematically simulated respiratory flow is physically simulated by at least one fan.
However, Glasgow discloses wherein a mathematically simulated respiratory flow is physically simulated by at least one fan, (“The flow generator 50B can control flows delivered to the patient 56 using one or more valve[s], or optionally the flow generator 50B can comprise a blower.” Glasgow [P.0088]. Examiner interprets “blower” to include at least one fan.)
Lampotang and Glasgow disclose the limitations of claim 9 and maintain the similar rationale for combination as claim 7.
Regarding claim 18, Lampotang fails to specifically disclose the limitations of claim 18, however Glasgow discloses wherein the system further comprises a respiratory gas humidifier and/or a respiratory gas heater. (“the controller can control components of the breathing assistance apparatus 10, including but not limited to: operating the flow generator to create a flow of gas(es) (gases flow) for delivery to a patient, operating the humidifier (if present) to humidify and/or heat the generated gases flow, controlling a flow of oxygen into the flow generator blower” Glasgow [P.0141])
Glasgow discloses the limitations of claim 18 and maintains similar rationale for combination with Lampotang as claim 7.
Regarding claim 19, Lampotang fails to specifically disclose the limitations of claim 19, however Glasgow discloses wherein the control module is configured and designed to at least partially control a ventilator (“the apparatus controller (i.e. control module) can be configured to control the flow generator (i.e. ventilator) and the valve and transmit signals to the apparatus user interface, wherein the respiratory apparatus can be configured to operate based on the received operating parameters and/or operational settings and the one or more signals from the peripheral device.” Glasgow [P.0045]) on the basis of the mathematical simulation (“the peripheral device can include software configured to model a virtual patient receiving therapy and communicate feedback to the respiratory apparatus in the form of the simulated measurement information of the virtual patient” Glasgow [P.0030]. The virtual patient model is interpreted as a mathematical simulation because “Mathematical approximations can be used in the construction of the models where empirical data for certain types of patients are unavailable or insufficient” Glasgow [P.0277]), the ventilator being connected to a real person. (“The flow source can provide a flow of gases that can be delivered to a patient (i.e. real person) via a delivery conduit 16, and patient interface 51.” Glasgow [P.0088].
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Glasgow discloses the limitations of claim 19 and maintains similar rationale for combination with Lampotang as claim 7.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Lampotang et al. US Patent No. 5584701 (hereinafter referred to as “Lampotang”),
in view of Marcel FR Doc. No. 2704762 A1 (hereinafter referred to as “Marcel”).
Regarding claim 12, Lampotang fails to specifically disclose the limitations of claim 12, however analogous art of Marcel discloses (see Lampotang claim 1 for gas module), the fan serving both as expiration unit and as inspiration unit by a switching of valves and bypass lines arranged in the gas module. (“The vacuum pump (includes a fan) always working in the same direction, a set of normally open and non-salient closed solenoid valves direct the suction flow (i.e. inspiration) to the equipment to be tested [...] and then after excitation, direct the exhalation flow (i.e. expiration) to the equipment under test [...] In the inspiratory phase, it is the suction circuit of the vacuum pump which is directed towards the device to be tested Fig.1. In the exhalation phase, the exhaust circuit of the pump is directed towards the device to be tested and the suction of the vacuum pump is directed to the ambient air Fig.2” Marcel [Pg.2 Ln.45-52]. Examiner interprets the vacuum pump to include a fan. Reference Figures 1 and 2 below for switching valve and bypass line arrangements. Note the vacuum pump is labeled “6”.)
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Lampotang and Marcel are analogous art as both relate to devices for simulating respiratory functions. Lampotang discloses a self-regulating simulated lung using bellows actuated by a piston, controlled by scripts or computer models, and equipped with sensors, pumps, and analyzers for advanced simulation and monitoring. And Marcel discloses an electropneumatic device using a dry vacuum pump to generate respiratory cycles, with features for gas and drug delivery, remote control, and adaptability to various environments. 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 Lampotang system to include the inspiration/expiration system, as taught by Marcel, in order “to create reproducible cycles of” various types of breathing patterns, Marcel [Pg.1 Ln.36].
Conclusion
The prior art made of record, listed on form PTO-892, and not relied upon is
considered pertinent to applicant's disclosure:
Bayerlein (Method for Controlling a Ventilating Apparatus Using a Simulator Arrangement – US Patent No 4917080). “The invention is directed to a method for controlling a ventilating apparatus wherein an adjustment selected according to patient data is changed for optimization after a work-in time period. A first simulator unit simulating the characteristic values of the ventilating apparatus and a second simulator unit simulating patient parameters taken from patient data are connected to a ventilating apparatus such that the new adjustment is processed first on the first simulator unit with unchanged adjustment of the ventilating apparatus. The resulting output values of the first simulator unit are coupled with the patient data of the second simulator unit such that the effects of the changed adjustment on the patient are derived as simulated new patient data. A switchover of the ventilating apparatus to the new adjustment can take place by means of a control command.” [Abstract]
Pasteka, Richard, Mathias Forjan, Stefan Sauermann, and Andreas Drauschke. "Electro-mechanical lung simulator using polymer and organic human lung equivalents for realistic breathing simulation." Scientific reports 9, no. 1 (2019): 19778. “This work introduces a respiratory simulation system, which is bridging the gap between the complex, real anatomical environment and the safe, cost-effective simulation methods. The presented electro-mechanical lung simulator, xPULM, combines in-silico, ex-vivo and mechanical respiratory approaches by realistically replicating an actively breathing human lung.” [Abstract]
Farmer et al. (Valving Arrangement For A Negative Pressure Ventilator – US Patent No 5299599 A). “A valving arrangement primarily designed and intended for use in a negative pressure ventilator system. The valve arrangement has a uniquely designed valve that enables the ventilator to perform a number of operations simply by manipulation of a single, one-piece valve member within a valve housing.” [Abstract]
Schwindth et al. (Patient Simulator – US Patent No 11475796 B2). “The lung simulator serves to simulate various states of a patient's lung, e.g. in terms of resistance and compliance, which is, in particular, of great advantage for practicing mechanical respiration or ventilation by the aid of a patient simulator on real breathing apparatus.” [Col.2 Ln.14]
Jonson (Method And Apparatus For Optimization Of Mechanical Ventilation – US Patent No 6578575 B1). “a mathematical description of the patient's respiratory system is produced in a computer from measured parameters related to properties of the respiratory system, and in the computer the mathematical descriptions for different modes of ventilation are tested on the mathematical description to obtain simulated results.” [Abstract]
Lampotang et al. (Apparatus And Method For Simulating Bronchial Resistance Or Dilation – US Patent No 5772442). “an improved patient simulator capable of realistically simulating nerve stimulation, lung movement, lung volume measurement and lung breathing noise, administration, detection, identification and quantification of medicaments and fluids introduced during simulated surgery.” [Col.1 Ln.27]
Oddo et al. (Mechanical Ventilator With Oxygen Concentrator – US Patent No 11229763 B2). “The present disclosure generally relates to a medical device, and more particularly, to a mechanical ventilator.” [Col.1 Ln.17]
Adametz et al. (Ventilator with Switching Valve – US Pub. No 2019/0275283 A1). “a ventilator with an apparatus input and an apparatus output and with an airway between the apparatus input and the apparatus output, wherein a breathing gas drive, a non-return valve and a switching valve are arranged in the airway.” [P.0002]
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/ANTHONY CHAVEZ/ Examiner, Art Unit 2186
/RENEE D CHAVEZ/Supervisory Patent Examiner, Art Unit 2186