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 .
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-4, 10-14, 17-19, and 21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 11839585. Although the claims at issue are not identical, they are not patentably distinct from each other because the reference claim recites every limitation of the instant claims. See table under paragraph 5 of this action below.
Claims 1-5, 7, and 9-22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 7 of U.S. Patent No. 11839585. Although the claims at issue are not identical, they are not patentably distinct from each other because the reference claim recites every limitation of the instant claims.
Instant Application
U.S. Patent No. 11839585
1
A ventilation monitoring system comprising:
[A] a processor; and
[B] a non-transitory computer-readable medium having instructions that, when executed by the processor, cause the processor to:
[C] monitor a ventilation signal, wherein the ventilation signal is at least partly based on at least one measurement from at least one sensor in fluid communication with airflows exchanged with lungs of a patient during ventilation of the patient; and
[D] determine whether at least one clinical artifact is present in the ventilation signal.
1.
A resuscitation and ventilation monitoring system, the system comprising:
[A] a processor; and
[B]a non-transitory computer-readable medium having instructions that, when executed by the processor, cause the processor to:
receive user input from a user, the user input comprising at least one of a height, weight, gender, or age of a patient;
[C] during a ventilation of the patient, generate a ventilation signal [L] indicative of a current mode of ventilation and associated ventilator settings based on at least one of airflow, pressure, oxygen, or carbon dioxide [O]measurements received from at least one of an airflow meter or one or more sensors in fluid communication with airflows exchanged with lungs of the patient;
[D]identify and [E] filter out at least one clinical artifact present in the ventilation signal, [F] wherein each of the at least one clinical artifact corresponds to a [K] ventilation event other than patient ventilator asynchrony;
[M] determine that the ventilation corresponds to patient ventilator asynchrony in response to determining that the current mode of ventilation and associated ventilator settings are not within a predetermined limit defined by the user input; and
based on the determination that the ventilation corresponds to patient ventilator asynchrony:
[F] identify a subtype of patient ventilator asynchrony observed, [G] wherein the patient ventilator asynchrony subtype is at least one of a double trigger asynchrony, breath stacking asynchrony, flow asynchrony, delayed termination asynchrony, early termination asynchrony, forced exhalation asynchrony, and ineffective trigger asynchrony;
[N] generate an alert indicating the presence of patient ventilator asynchrony; and
suggest user-implementable corrective action, via a user interface, to adjust ventilator settings of a mechanical ventilator in order to correct the patient ventilator asynchrony.
2
The ventilation monitoring system of claim 1, wherein the instructions of the non- transitory computer-readable medium, when executed by the processor, further cause the processor to [E] filter out the at least one clinical artifact from the ventilation signal.
7.
The resuscitation and ventilation monitoring system of claim 1, wherein the at least one clinical artifact corresponds to at least one of [H] a suction event, [I] a cough, or [J] a patient-ventilator disconnect.
3
The ventilation monitoring system of claim 1, wherein the instructions of the non- transitory computer-readable medium, when executed by the processor, further cause the processor to [F] differentiate between the at least one clinical artifact and patient ventilator asynchrony.
4
The ventilation monitoring system of claim 3, wherein [G] the patient ventilator asynchrony comprises double trigger asynchrony, breath stacking asynchrony, flow asynchrony, delayed termination asynchrony, early termination asynchrony, forced exhalation asynchrony, and/or ineffective trigger asynchrony.
5
The ventilation monitoring system of claim 1, wherein the at least one clinical artifact comprises [H] at least one suction event during the ventilation of the patient.
7
The ventilation monitoring system of claim 1, wherein the at least one clinical artifact comprises [I] at least one cough by the patient during the ventilation of the patient.
9
The ventilation monitoring system of claim 1, wherein the at least one clinical artifact comprises [J] at least one patient-ventilator disconnect event.
10
The ventilation monitoring system of claim 1, wherein the at least one clinical artifact corresponds to [K] a ventilation event other than patient ventilator asynchrony.
11
The ventilation monitoring system of claim 1, wherein the ventilation signal is [L] indicative of a current mode of ventilation and associated ventilator settings based on an airflow measurement, a pressure measurement, an oxygen measurement, and/or a carbon dioxide measurement received from the at least one sensor.
12
The ventilation monitoring system of claim 11, wherein the instructions of the non- transitory computer-readable medium, when executed by the processor, further cause the processor to [M] determine that the ventilation signal corresponds to patient ventilator asynchrony in response to determining that the current mode of ventilation and associated ventilator settings are not within a predetermined limit.
13
The ventilation monitoring system of claim 12, wherein the instructions of the non- transitory computer-readable medium, when executed by the processor, further cause the processor to [N] generate an alert indicating a presence of patient ventilator asynchrony.
14
The ventilation monitoring system of claim 1, wherein the [O] at least one sensor comprises an airflow meter, a pressure sensor, an oxygen sensor, a carbon dioxide sensor, a temperature sensor, and/or a humidity sensor.
16
The ventilation monitoring system of claim 1, wherein the processor [D] determines the presence of the at least one clinical artifact in the ventilation signal [L] at least partly based on a measured pressure and/or flow waveforms, and wherein the at least one clinical artifact comprises [H] at least one suction event during the ventilation of the patient, closed in-line suctioning of secretions through an endotracheal tube, [I] at least one cough by the patient during the ventilation of the patient, and/or at least one cough morphology resembling patient ventilator asynchrony.
17
A method of monitoring ventilation of a patient, the method comprising:
[C] monitoring a ventilation signal, wherein the ventilation signal is at least partly based on at least one measurement from at least one sensor in fluid communication with airflows exchanged with lungs of the patient during ventilation of the patient; and
[D] determining whether at least one clinical artifact is present in the ventilation signal.
18
The method of claim 17, further comprising [E] filtering out the at least one clinical artifact from the ventilation signal.
19
The method of claim 18, wherein the at least one clinical artifact corresponds to [K] a ventilation event other than patient ventilator asynchrony.
20
The method of claim 17, wherein the at least one clinical artifact comprises [H] at least one suction event during the ventilation of the patient, [I] at least one cough by the patient during the ventilation of the patient, at least one cough morphology resembling patient ventilator asynchrony, and/or [J] at least one patient-ventilator disconnect event.
21
The method of claim 17, wherein [L] the ventilation signal is indicative of a current mode of ventilation and associated ventilator settings based on an airflow measurement, a pressure measurement, an oxygen measurement, and/or a carbon dioxide measurement received from the at least one sensor.
22
The method of claim 17, wherein the [D] determination of whether the at least one clinical artifact is present in the ventilation signal is [L] at least partly based on a measured pressure and/or flow waveforms, and wherein the at least one clinical artifact comprises [H] at least one suction event during the ventilation of the patient, closed in-line suctioning of secretions through an endotracheal tube, [I] at least one cough by the patient during the ventilation of the patient, and/or at least one cough morphology resembling patient ventilator asynchrony.
Claims 1-2, 11, 14, 17-18, and 21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 11464703. Although the claims at issue are not identical, they are not patentably distinct from each other because the reference claim recites every limitation of the instant claims. See table under paragraph 7 of this action below.
Claims 1-2, 5, 7, 9, 11, 14, 16-18, and 20-22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 6 of U.S. Patent No. 11464703. Although the claims at issue are not identical, they are not patentably distinct from each other because the reference claim recites every limitation of the instant claims.
Instant Application
U.S. Patent No. 11464703
1
A ventilation monitoring system comprising:
[A] a processor; and
[B] a non-transitory computer-readable medium having instructions that, when executed by the processor, cause the processor to:
[C] monitor a ventilation signal, wherein the ventilation signal is at least partly based on at least one measurement from at least one sensor in fluid communication with airflows exchanged with lungs of a patient during ventilation of the patient; and
[D] determine whether at least one clinical artifact is present in the ventilation signal.
1.
A resuscitation and ventilation monitoring system, the system comprising:
[A] a processor; and
[B]a non-transitory computer-readable medium having instructions that, when executed by the processor, cause the processor to:
receive user input from a user, the user input comprising at least one of a height, weight, gender, or age of a patient;
[C] during a ventilation of the patient, generate a ventilation signal [L] indicative of a current mode of ventilation and associated ventilator settings based on at least one of airflow, pressure, oxygen, or carbon dioxide [O]measurements received from at least one of an airflow meter or one or more sensors in fluid communication with airflows exchanged with lungs of the patient;
[D]identify and [E] filter out at least one artifact present in the ventilation signal,
classify the ventilation as either on-target or off-target based on whether the current mode of ventilation and associated ventilator settings are within a predetermined limit defined by the user input;
determine off-target ventilation type and generate an alert if the ventilation is off-target; and
suggest corrective action based on the off-target ventilation type via a user interface if the alert is generated, the suggested corrective action implementable by the user to adjust a manual bagging of the patient or ventilator settings of a mechanical ventilator.
2
The ventilation monitoring system of claim 1, wherein the instructions of the non- transitory computer-readable medium, when executed by the processor, further cause the processor to [E] filter out the at least one clinical artifact from the ventilation signal.
6.
The resuscitation and ventilation monitoring system of claim 1, wherein the at least one ventilation signal artifact corresponds to at least one of [H] a suction event, [I] a cough, or [J] a patient-ventilator disconnect.
5
The ventilation monitoring system of claim 1, wherein the at least one clinical artifact comprises [H] at least one suction event during the ventilation of the patient.
7
The ventilation monitoring system of claim 1, wherein the at least one clinical artifact comprises [I] at least one cough by the patient during the ventilation of the patient.
9
The ventilation monitoring system of claim 1, wherein the at least one clinical artifact comprises [J] at least one patient-ventilator disconnect event.
11
The ventilation monitoring system of claim 1, wherein the ventilation signal is [L] indicative of a current mode of ventilation and associated ventilator settings based on an airflow measurement, a pressure measurement, an oxygen measurement, and/or a carbon dioxide measurement received from the at least one sensor.
14
The ventilation monitoring system of claim 1, wherein the [O] at least one sensor comprises an airflow meter, a pressure sensor, an oxygen sensor, a carbon dioxide sensor, a temperature sensor, and/or a humidity sensor.
16
The ventilation monitoring system of claim 1, wherein the processor [D] determines the presence of the at least one clinical artifact in the ventilation signal [L] at least partly based on a measured pressure and/or flow waveforms, and wherein the at least one clinical artifact comprises [H] at least one suction event during the ventilation of the patient, closed in-line suctioning of secretions through an endotracheal tube, [I] at least one cough by the patient during the ventilation of the patient, and/or at least one cough morphology resembling patient ventilator asynchrony.
17
A method of monitoring ventilation of a patient, the method comprising:
[C] monitoring a ventilation signal, wherein the ventilation signal is at least partly based on at least one measurement from at least one sensor in fluid communication with airflows exchanged with lungs of the patient during ventilation of the patient; and
[D] determining whether at least one clinical artifact is present in the ventilation signal.
18
The method of claim 17, further comprising [E] filtering out the at least one clinical artifact from the ventilation signal.
20
The method of claim 17, wherein the at least one clinical artifact comprises [H] at least one suction event during the ventilation of the patient, [I] at least one cough by the patient during the ventilation of the patient, at least one cough morphology resembling patient ventilator asynchrony, and/or [J] at least one patient-ventilator disconnect event.
21
The method of claim 17, wherein [L] the ventilation signal is indicative of a current mode of ventilation and associated ventilator settings based on an airflow measurement, a pressure measurement, an oxygen measurement, and/or a carbon dioxide measurement received from the at least one sensor.
22
The method of claim 17, wherein the [D] determination of whether the at least one clinical artifact is present in the ventilation signal is [L] at least partly based on a measured pressure and/or flow waveforms, and wherein the at least one clinical artifact comprises [H] at least one suction event during the ventilation of the patient, closed in-line suctioning of secretions through an endotracheal tube, [I] at least one cough by the patient during the ventilation of the patient, and/or at least one cough morphology resembling patient ventilator asynchrony.
Claim 8 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 7 of U.S. Patent No. 11839585 in view of Covidien (US 20140150795 A1).
Covidien, in the same field of endeavor of a system for monitoring the ventilation of a patient, discloses wherein the at least one clinical artifact comprises at least one cough morphology resembling patient ventilator asynchrony (Paragraph 0029-0033, 0051--a double-triggering event may occur due to a cough, sigh, or yawn… an isolated double-triggering event or a few intermittent double-triggering events may not necessarily indicate that the patient may benefit from an adjustment in ventilator settings and/or a different ventilator operating mode…).
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the system of the reference application, which discloses detecting a double trigger asynchrony, with the teachings of Covidien which disclose detecting at least one cough morphology resembling patient ventilator asynchrony by the patient in the form of a double-triggering event in the ventilation signal in order to predictably improve the ability of the system to detect additional causes of clinical artifacts and distinguish between these causes and ventilation asynchrony.
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.
Utilizing the two step process adopted by the Supreme Court (Alice Corp vs CLS Bank Int'l, US
Supreme Court, 110 USPQ2d 1976 (2014) and the recent 101 guideline Federal Register Vol. 84, No., Jan
2019)), determination of the subject matter eligibility under the 35 U.S.C. 101 is as follows: Specifically, the Step 1 requires claim belongs to one of the four statutory categories (process, machine, manufacture, or composition of matter). If Step 1 is satisfied, then in the first part of Step 2A (Prong One), identification of any judicial recognized exceptions in the claim is made. If any limitation in the claim is identified as judicial recognized exception, then in the second part of Step 2A (Prong Two), determination is made whether the identified judicial exception is being integrated into practical application. If the identified judicial exception is not integrated into a practical application, then in Step 2B, the claim is further evaluated to see if the additional elements, individually and in combination provide "inventive concept" that would amount to significantly more than the judicial exception. If the element and combination of elements do not amount to significantly more than the judicial recognized exception itself, then the claim is ineligible under the 35 U.S.C. 101.
Claims 1-22 are rejected under 35 U.S.C. 101.
Claim 1 is rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception, in this case an abstract idea, without significantly more. The claim recite(s) "determine whether at least one clinical artifact is present in the ventilation signal". This judicial exception is not integrated into a practical application and the claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception.
Claim 1 satisfies Step 1, namely the claim is directed to one of the four statutory classes, machine. Following Step 2A Prong one, any judicial exceptions are identified in the claims. In claim 1, the limitations "determine whether at least one clinical artifact is present in the ventilation signal" are abstract ideas as they are directed to a mental process or mathematical concept. With the identification of an abstract idea, the next phase is to proceed Step 2A, Prong Two, wherewith additional elements and taken as a whole, evaluation occurs of whether the identified abstract idea is integrated into a practical application.
In Step 2A, Prong Two, the claim does not recite any additional elements or evidence that amounts to significantly more than the judicial exception. Besides the abstract idea, the claim recites the additional elements “a processor; and a non-transitory computer-readable medium having instructions that, when executed by the processor, cause the processor to: monitor a ventilation signal, wherein the ventilation signal is at least partly based on at least one measurement from at least one sensor in fluid communication with airflows exchanged with lungs of a patient during ventilation of the patient”. However, these components may be seen as the use of well-understood, routine, or conventional elements to perform a non-mental process in order to gather data for the mental process step, much like the example given in MPEP 2106.04(d)(2)(c), such that these limitations are extra-solution activity and thus do not integrate the judicial exception into a practical application. The measurement step leads to the final limitation of “determin[ing]” such that the end result of use of the system is only the generic determined presence of at least one clinical artifact which may be any generic output, or no output at all. As this determination is not defined as requiring any further action, such as a form of prophylaxis or treatment or an improvement to a computer or other technology, the claim limitations constitute mere generation of data, in this case the measurement of a ventilation signal, such that the claim does not integrate the judicial exception into any practical application. Regarding “a processor”, the limitation amounts to nothing more than an instruction to apply the abstract idea using a generic computer, which does not render an abstract idea eligible. The steps performed by the processor are, as claimed, capable of being performed in the human mind similar to the examples given in MPEP 2106.04(a)(2)(III)(A)-(C), wherein it is described that “a claim to ‘collecting information, analyzing it, and displaying certain results of the collection and analysis’ where the data analysis steps are recited at a high level of generality such that they could practically be performed in the human mind” recites a mental process and that claims which merely use a computer as a tool to perform a mental process are not eligible when “there is nothing in the claims themselves that foreclose them from being performed by a human, mentally or with pen and paper” such as “mental processes of parsing and comparing data” when the steps are recited at a high level of generality and a computer is used merely as a tool to perform the processes. Under the broadest reasonable interpretation, the claim elements are recited with a high level of generality (as written, each claimed step of the processor may be performed by a person in an undefined manner) that there are no meaningful limitations to the abstract idea. Consequently, with the identified abstract idea not being integrated into a practical application, the next step is Step 2B, evaluating whether the additional elements provide "inventive concept" that would amount to significantly more than the abstract idea.
In Step 2B, claim 1 does not include additional elements that are sufficient to amount to significantly more than the judicial exception. The limitation of “a processor; and a non-transitory computer-readable medium having instructions that, when executed by the processor, cause the processor to: monitor a ventilation signal, wherein the ventilation signal is at least partly based on at least one measurement from at least one sensor in fluid communication with airflows exchanged with lungs of a patient during ventilation of the patient” constitutes extra-solution activity to the judicial exception, which does not amount to an inventive concept when the activity is well-understood, routine, or conventional, and are thus not indicative of integration into a practical application. The claim limitation constitutes adding a generic processor, memory, and sensor, which Covidien (US 20140150795 A1) demonstrates to be well-understood, routine, or conventional in its description of processor and memory components (Paragraph 0022) and sensors for obtaining ventilation signals which may be “any suitable sensor 48 for determining flow, pressure, nerve impulses, concentrations of components in the patient's respiratory gas, or any other desired parameter may be used. For example, the sensors 48 may be pressure sensors, flow sensors, electroencephalogy (EEG) sensors, neural sensors, and/or optical sensors” (Paragraph 0022-0024). This is further shown with the presence of such components in a ventilation monitoring system in Milne (US 20150090258 A1, see paragraphs 0004-0005, 0045-0046, and 0049 for processor and memory “components of the type commonly found in command and control computing devices” and paragraphs 0052-0057, 0083, 0115-0118, 0120, 0124 for sensors “any suitable sensing device as known by a person of skill in the art for a ventilator”) and Mulqueeny (US 20120037159 A1, see paragraph 0271, 0293 for processor and memory “a programmed general purpose computer having memory and one or more processors or a specific purpose computer” and paragraphs 0291-0291 for sensors). As discussed above with respect to integration of the abstract idea into a practical application, the present elements amount to no more than mere indications to apply the exception.
In Summary, claim 1 recites abstract idea without being integrated into a practical application, and does not provide additional elements that would amount to significantly more. As such, taken as a whole, the claim and is ineligible under the 35 U.S.C. 101.
Claims 2-16 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception, in this case an abstract idea, without significantly more. As each of these claims depends from claim 1, which was rejected under 35 U.S.C. 101 in paragraph 11 of this action, these claims must be evaluated on whether they sufficiently add to the practical application of claim 1, or comprise significantly more than the limitations of claim 1.
Besides the abstract idea of claim 1: claims 2-3 and 12 recite additional limitations which are themselves abstract ideas directed toward mental processes or mathematical concepts as “filtering”, “differentiating”, and “determining” may be performed in the human mind such as through a basic mathematical calculation; claims 4-10 and 16 recite further details of the abstract ideas of claim 1 as identified above which may additionally be seen as abstract as a presence of a particular kind of artifact may be determined in the human mind such as by observing a signal for a particular change in amplitude or morphology; claims 11, 13-15 disclose additional components for the use of well-understood, routine, or conventional elements to perform a non-mental process in order to gather data for the mental process step or output data from the mental process step, much like the example given in MPEP 2106.04(d)(2)(c), such that these limitations are extra-solution activity and thus do not integrate the judicial exception into a practical application.
The limitation of “the at least one sensor” of claim 11, “generate an alert” in claim 13, “the at least one sensor comprises an airflow meter, a pressure sensor, an oxygen sensor, a carbon dioxide sensor, a temperature sensor, and/or a humidity sensor” in claim 14, and “generate a visual representation of the ventilation signal on a display” in claim 15 constitutes extra-solution activity to the judicial exception, which does not amount to an inventive concept when the activity is well-understood, routine, or conventional, and are thus not indicative of integration into a practical application. The claim limitation constitutes adding a generic sensor and generic display or output device, which Covidien (US 20140150795 A1) demonstrates to be well-understood, routine, or conventional in its description of airflow or pressure sensors for obtaining ventilation signals which may be “any suitable sensor 48 for determining flow, pressure, nerve impulses, concentrations of components in the patient's respiratory gas, or any other desired parameter may be used. For example, the sensors 48 may be pressure sensors, flow sensors, electroencephalogy (EEG) sensors, neural sensors, and/or optical sensors” (Paragraph 0022-0024) and a display “a visual indication, which may be textual, graphical, or any other suitable indication” (Paragraph 0032, 0035-0038 and Figs. 3-10). This is further shown with the presence of such components in a ventilation monitoring system in Milne (US 20150090258 A1, see paragraphs 0052-0057, 0083, 0115-0118, 0120, 0124 for airflow or pressure sensors “any suitable sensing device as known by a person of skill in the art for a ventilator” and paragraph 0011, 0045, 0050 for display) and Mulqueeny (US 20120037159 A1, see paragraphs 0291-0291 for airflow or pressure sensors and paragraph 0049, 0101, 0298 for display). The claim element of claim 1 of a ventilation monitoring system is recited with a high level of generality (as written, the actions of the processing circuitry may be carried out by a person alone or with a generic computer in any undefined manner). The limitations of claims 2-16 provide no practical application, nor do they provide meaningful limitations to the abstract idea.
Claim 17 is rejected for similar reasons to claim 1.
Claims 18-22 are rejected for similar reasons to claims 2-16.
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.
Claim(s) 1, 3-4, 9-15, 17, 20-21 is/are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Milne (US 20150090258 A1).
Regarding claim 1, Milne teaches a ventilation monitoring system (Paragraph 0005, 0048-- a ventilatory system for issuing a smart prompt when asynchrony is implicated during ventilation of a patient is provided) comprising:
a processor (Paragraph 0005, 0045, 0049—at least one processor); and
a non-transitory computer-readable medium having instructions that, when executed by the processor (Paragraph 0004-0005, 0046, 0049-- The at least one memory is communicatively coupled to the at least one processor and contains instructions that are executed by the at least one processor), cause the processor to:
monitor a ventilation signal, wherein the ventilation signal is at least partly based on at least one measurement from at least one sensor in fluid communication with airflows exchanged with lungs of a patient during ventilation of the patient (Paragraph 0052-0057, 0083, 0115-0118, 0120, 0124-- the ventilator may detect patient triggering via a pressure-monitoring method, a flow-monitoring method, direct or indirect measurement of neuromuscular signals, or any other suitable method. Internal sensors 220 and/or distributed sensors 218 suitable for this detection may include any suitable sensing device as known by a person of skill in the art for a ventilator); and
determine whether at least one clinical artifact is present in the ventilation signal (Paragraph 0132-- data processing module 222 may be configured to determine if the ventilation tubing system 130 or patient circuit has become disconnected from the patient or the ventilator during ventilation. Data processing module 222 determines that a patient circuit is disconnected by any suitable means. In some embodiments, data processing module 222 determines that the patient circuit is disconnected by evaluating data, such as exhaled pressure and/or exhaled volume; paragraph 0134-0135, 0151-0174, 0182-0198-- ventilator 202 may further include asynchrony module 224. Asynchrony is detected by the asynchrony module 224 when an ineffective effort, an auto-trigger, a late trigger, an early cycle, a late cycle, a double trigger, an inadequate flow, and/or a high tidal volume is detected; paragraph 0136-0138-- Ventilator 202 may further include an ineffective effort detection module 224a. An ineffective effort, as used herein, is a patient inspiratory effort that does not result in the delivery of a breath by the ventilator. An ineffective effort occurs when the ventilator does not detect a patient inspiratory expiratory effort.; paragraph 0139-0146-- Ventilator 202 may further include an auto-trigger detection module 224c. An auto-trigger, as used herein, occurs when the ventilator delivers inspiration prior to a patient's desire for an inspiration or prior to a patient's inspiratory effort).
Regarding claim 3, Milne teaches the ventilation monitoring system of claim 1. Milne additionally teaches wherein the instructions of the non- transitory computer-readable medium, when executed by the processor, further cause the processor to differentiate between the at least one clinical artifact and patient ventilator asynchrony (Paragraph 0134-0135, 0151-0174-- the recommendation message may be based on particular ventilatory parameter(s) (e.g., respiration rate, expiratory time, tidal volume, etc.) that implicated asynchrony. Additionally or alternatively, the recommendation message may be based on current ventilatory settings (e.g., breath type, patient interface type, and etc.) such that suggestions are directed to a particular patient's treatment. Additionally or alternatively, the recommendation message may be based on secondary conditions (e.g., elevated resistance, leak detection, and etc.) such that suggestions are directed to a particular patient's treatment…based on the particular parameters that implicated asynchrony, the recommendation module 230 provides suggestions for addressing asynchrony… That is, if auto-trigger is implicated, the one or more recommendation messages may include suggestions or recommendations for the following…).
Regarding claim 4, Milne teaches the ventilation monitoring system of claim 3. Milne additionally teaches wherein the patient ventilator asynchrony comprises double trigger asynchrony, breath stacking asynchrony, flow asynchrony, delayed termination asynchrony, early termination asynchrony, forced exhalation asynchrony, and/or ineffective trigger asynchrony (Paragraph 0134-0135-- Asynchrony is detected by the asynchrony module 224 when an ineffective effort, an auto-trigger, a late trigger, an early cycle, a late cycle, a double trigger, an inadequate flow, and/or a high tidal volume is detected).
Regarding claim 9, Milne teaches the ventilation monitoring system of claim 1. Milne additionally teaches wherein the at least one clinical artifact comprises at least one patient-ventilator disconnect event (Paragraph 0132-- data processing module 222 may be configured to determine if the ventilation tubing system 130 or patient circuit has become disconnected from the patient or the ventilator during ventilation… data processing module 222 determines that the patient circuit is disconnected by evaluating data, such as exhaled pressure and/or exhaled volume).
Regarding claim 10, Milne teaches the ventilation monitoring system of claim 1. Milne additionally teaches wherein the at least one clinical artifact corresponds to a ventilation event other than patient ventilator asynchrony (Paragraph 0136-0138-- Ventilator 202 may further include an ineffective effort detection module 224a. An ineffective effort, as used herein, is a patient inspiratory effort that does not result in the delivery of a breath by the ventilator. An ineffective effort occurs when the ventilator does not detect a patient inspiratory expiratory effort. The ventilator may not detect the inspiratory because the trigger threshold is set too high and/or because the inspiratory is below the minimum trigger detection level for the trigger type; paragraph 0154-0174-- enable leak compensation… check patient circuit for condensate… check for causes of increased resistance…).
Regarding claim 11, Milne teaches the ventilation monitoring system of claim 1. Milne additionally teaches wherein the ventilation signal is indicative of a current mode of ventilation and associated ventilator settings based on an airflow measurement, a pressure measurement, an oxygen measurement, and/or a carbon dioxide measurement received from the at least one sensor (Paragraph 0008, 0148, 0153, 0186, 0201-0203--The ventilatory system includes: means for detecting an auto-trigger based on at least one of a monitored respiration rate and an expiratory time, means for identifying the current ventilator settings and secondary conditions; paragraph 0120-0121--any suitable device either known or developed in the future may be used for detecting airflow in the ventilatory circuit; paragraph 0124-0125--Pressure may be measured by any appropriate, internal or distributed device or sensor within the ventilatory system 200).
Regarding claim 12, Milne teaches the ventilation monitoring system of claim 11. Milne additionally teaches wherein the instructions of the non- transitory computer-readable medium, when executed by the processor, further cause the processor to determine that the ventilation signal corresponds to patient ventilator asynchrony in response to determining that the current mode of ventilation and associated ventilator settings are not within a predetermined limit (Paragraph 0201-0205-- the ventilator may identify one or more ventilatory parameters that implicated asynchrony and/or secondary patient conditions. For example, at operation 404, the ventilator may identify if the patient has an elevated resistance, if the patient exhibits a long inspiratory time, if the patient suffers from auto PEEP, if the patient has a high tidal volume, and/or if a leak is detected… Based on the parameters that implicated the asynchrony, the ventilator during the parameters operation 404 may further identify the type of asynchrony detected, such as ineffective effort and/or auto-trigger).
Regarding claim 13, Milne teaches the ventilation monitoring system of claim 12. Milne additionally teaches wherein the instructions of the non- transitory computer-readable medium, when executed by the processor, further cause the processor to generate an alert indicating a presence of patient ventilator asynchrony (Paragraph 0201-0205-- As may be appreciated, the ventilator may also use information regarding ventilatory parameters that implicated asynchrony in determining an appropriate notification and/or recommendation message of the smart prompt… For example, the appropriate notification message may alert the clinician that asynchrony has been implicated and, optionally, may provide information regarding the type of asynchrony and the ventilatory parameter(s) that implicated asynchrony.).
Regarding claim 14, Milne teaches the ventilation monitoring system of claim 1. Milne additionally teaches wherein the at least one sensor comprises an airflow meter, a pressure sensor, an oxygen sensor, a carbon dioxide sensor, a temperature sensor, and/or a humidity sensor (Paragraph 0115-0117-- Distributed sensors 218 may further include pressure transducers that may detect changes in circuit pressure (e.g., electromechanical transducers including piezoelectric, variable capacitance, or strain gauge). Distributed sensors 218 may further include various flowmeters for detecting airflow (e.g., differential pressure pneumotachometers)…).
Regarding claim 15, Milne teaches the ventilation monitoring system of claim 1. Milne additionally teaches wherein the instructions of the non- transitory computer-readable medium, when executed by the processor, further cause the processor to generate a visual representation of the ventilation signal on a display (Paragraph 0050-- The GUI may be an interactive display, e.g., a touch-sensitive screen or otherwise, and may provide various windows (i.e., visual areas) comprising elements for receiving user input and interface command operations and for displaying ventilatory information (e.g., including ventilatory data, alerts, patient information, parameter settings, etc.)… Display module 204 may also provide useful information in the form of various ventilatory data regarding the physical condition of a patient and/or a prescribed respiratory treatment…).
Regarding claim 16, Milne teaches the ventilation monitoring system of claim 1. Milne additionally teaches wherein the processor determines the presence of the at least one clinical artifact in the ventilation signal at least partly based on a measured pressure and/or flow waveforms, and wherein the at least one clinical artifact comprises at least one suction event during the ventilation of the patient, closed in-line suctioning of secretions through an endotracheal tube, at least one cough by the patient during the ventilation of the patient, and/or at least one cough morphology resembling patient ventilator asynchrony.
Regarding claim 17, Milne teaches a method of monitoring ventilation of a patient (Paragraph 0005, 0048-- a ventilatory system for issuing a smart prompt when asynchrony is implicated during ventilation of a patient is provided) the method comprising:
monitoring a ventilation signal, wherein the ventilation signal is at least partly based on at least one measurement from at least one sensor in fluid communication with airflows exchanged with lungs of the patient during ventilation of the patient (Paragraph 0052-0057, 0083, 0115-0118, 0120, 0124-- the ventilator may detect patient triggering via a pressure-monitoring method, a flow-monitoring method, direct or indirect measurement of neuromuscular signals, or any other suitable method. Internal sensors 220 and/or distributed sensors 218 suitable for this detection may include any suitable sensing device as known by a person of skill in the art for a ventilator); and
determining whether at least one clinical artifact is present in the ventilation signal (Paragraph 0132-- data processing module 222 may be configured to determine if the ventilation tubing system 130 or patient circuit has become disconnected from the patient or the ventilator during ventilation. Data processing module 222 determines that a patient circuit is disconnected by any suitable means. In some embodiments, data processing module 222 determines that the patient circuit is disconnected by evaluating data, such as exhaled pressure and/or exhaled volume; paragraph 0134-0135, 0151-0174, 0182-0198-- ventilator 202 may further include asynchrony module 224. Asynchrony is detected by the asynchrony module 224 when an ineffective effort, an auto-trigger, a late trigger, an early cycle, a late cycle, a double trigger, an inadequate flow, and/or a high tidal volume is detected; paragraph 0136-0138-- Ventilator 202 may further include an ineffective effort detection module 224a. An ineffective effort, as used herein, is a patient inspiratory effort that does not result in the delivery of a breath by the ventilator. An ineffective effort occurs when the ventilator does not detect a patient inspiratory expiratory effort.; paragraph 0139-0146-- Ventilator 202 may further include an auto-trigger detection module 224c. An auto-trigger, as used herein, occurs when the ventilator delivers inspiration prior to a patient's desire for an inspiration or prior to a patient's inspiratory effort).
Regarding claim 20, Milne teaches the method of claim 17. Milne additionally teaches wherein the at least one clinical artifact comprises at least one suction event during the ventilation of the patient, at least one cough by the patient during the ventilation of the patient, at least one cough morphology resembling patient ventilator asynchrony, and/or at least one patient-ventilator disconnect event (Paragraph 0132-- data processing module 222 may be configured to determine if the ventilation tubing system 130 or patient circuit has become disconnected from the patient or the ventilator during ventilation. Data processing module 222 determines that a patient circuit is disconnected by any suitable means. In some embodiments, data processing module 222 determines that the patient circuit is disconnected by evaluating data, such as exhaled pressure and/or exhaled volume).
Regarding claim 21, Milne teaches the method of claim 17. Milne additionally teaches wherein the ventilation signal is indicative of a current mode of ventilation and associated ventilator settings based on an airflow measurement, a pressure measurement, an oxygen measurement, and/or a carbon dioxide measurement received from the at least one sensor (Paragraph 0008, 0148, 0153, 0186, 0201-0203--The ventilatory system includes: means for detecting an auto-trigger based on at least one of a monitored respiration rate and an expiratory time, means for identifying the current ventilator settings and secondary conditions; paragraph 0120-0121--any suitable device either known or developed in the future may be used for detecting airflow in the ventilatory circuit; paragraph 0124-0125--Pressure may be measured by any appropriate, internal or distributed device or sensor within the ventilatory system 200).
Claim(s) 1, 3-4, 7-8, 11-17, 20-22 is/are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Covidien (US 20140150795 A1).
Regarding claim 1, Covidien discloses a ventilation monitoring system (Paragraph 0017-0019) comprising:
a processor (Processor 38); and
a non-transitory computer-readable medium having instructions that, when executed by the processor (Paragraph 0022-- The processor 38 may access and execute coded instructions, such as for implementing the algorithms discussed herein, from one or more storage components of the ventilator 12, such as a RAM 40, ROM 42, and/or a mass storage device 44…), cause the processor to:
monitor a ventilation signal, wherein the ventilation signal is at least partly based on at least one measurement from at least one sensor in fluid communication with airflows exchanged with lungs of a patient during ventilation of the patient (Paragraph 0022-0024-- the processor 38 may receive information from one or more sensors 48 of the ventilation system 10… sensors 48 located within the ventilator 12, such as within the inspiratory and the expiratory modules 26 and 28. Additionally, sensors 48 may be disposed about the respiratory circuit 14. In certain embodiments, inspiratory, expiratory, and patient conduits 16, 18, and 20 and the Y-connector 22 may each include one or more sensors 48. Additionally, it may be desirable to obtain measurements near the lungs and/or near the diaphragm of the patient. As such, one or more sensors 48 may be located within or disposed about the patient interface 24); and
determine whether at least one clinical artifact is present in the ventilation signal (Paragraph 0027-0033-- the processor 38 may detect a decrease in pressure and/or flow in the patient's airway… the processor 38 may determine that a double-triggering event occurred if the exhaled tidal volume is less than the threshold volume. Moreover, the processor 38 may be configured to monitor other parameters to detect double-triggering events, such as the expiratory time or the ratio of the exhaled tidal volume with respect to the inhaled tidal volume…A zero millimeter threshold may identify double-triggering events that may be caused by inappropriate ventilator settings, rather than coughs, sighs, and yawns. For example, the patient may transition to expiration without triggering a stacked breath, but the patient may cough, sigh, or yawn during the expiratory period, which may trigger a stacked breath. As such, this double-triggering event may not indicate that the patient may benefit from an adjustment in ventilator settings. In contrast, an exhaled tidal volume that is approximately equal to zero millimeters may indicate that the patient did not expire between the two breaths. Rather, it may indicate that the patient continued to inspire (e.g., to achieve a greater inhaled tidal volume and/or a longer inspiratory time), thus, triggering a stacked breath.).
Regarding claim 3, Covidien teaches the ventilation monitoring system of claim 1. Covidien additionally discloses wherein the instructions of the non- transitory computer-readable medium, when executed by the processor, further cause the processor to differentiate between the at least one clinical artifact and patient ventilator asynchrony (Paragraph 0029-0033-- A zero millimeter threshold may identify double-triggering events that may be caused by inappropriate ventilator settings, rather than coughs, sighs, and yawns… determining whether the exhaled tidal volume is approximately equal to zero may be desirable to more accurately identify double-triggering events that may be more indicative of inappropriate ventilator settings).
Regarding claim 4, Covidien teaches the ventilation monitoring system of claim 3. Covidien additionally discloses wherein the patient ventilator asynchrony comprises double trigger asynchrony, breath stacking asynchrony, flow asynchrony, delayed termination asynchrony, early termination asynchrony, forced exhalation asynchrony, and/or ineffective trigger asynchrony (Paragraph 0004--the caregiver may wish to monitor the degree of asynchrony between the patient and the ventilator. Asynchrony may occur when the patient's neural inspiratory time (i.e., the patient's desired inspiratory time) differs from the mechanical inspiratory time set by the ventilator. Double-triggering, which is a type of asynchrony, may occur when the patient's neural inspiratory time is greater than the preset mechanical inspiratory time and/or when the patient's desired flow is greater than the preset flow…; Paragraph 0029-0033--a double-triggering event may result from a patient cough, a patient sigh, a patient yawn, inappropriate ventilator settings (e.g., inspiratory time, inhaled tidal volume, and/or respiratory rate), and/or a condition of the patient. A zero millimeter threshold may identify double-triggering events that may be caused by inappropriate ventilator settings, rather than coughs, sighs, and yawns…).
Regarding claim 7, Covidien teaches the ventilation monitoring system of claim 1. Covidien additionally discloses wherein the at least one clinical artifact comprises at least one cough by the patient during the ventilation of the patient (Paragraph 0029-0033, 0051--a double-triggering event may occur due to a cough, sigh, or yawn… an isolated double-triggering event or a few intermittent double-triggering events may not necessarily indicate that the patient may benefit from an adjustment in ventilator settings and/or a different ventilator operating mode…).
Regarding claim 8, Covidien teaches the ventilation monitoring system of claim 1. Covidien additionally discloses wherein the at least one clinical artifact comprises at least one cough morphology resembling patient ventilator asynchrony (Paragraph 0029-0033, 0051--a double-triggering event may occur due to a cough, sigh, or yawn… an isolated double-triggering event or a few intermittent double-triggering events may not necessarily indicate that the patient may benefit from an adjustment in ventilator settings and/or a different ventilator operating mode…).
Regarding claim 11, Covidien teaches the ventilation monitoring system of claim 1. Covidien additionally discloses wherein the ventilation signal is indicative of a current mode of ventilation and associated ventilator settings (Paragraph 0025-0026-- Additionally, the inspiratory and expiratory modules 26 and 28 may be configured to terminate the delivered breath and transition to expiration based at least in part upon a preset inspiratory time, inhaled tidal volume, and/or respiratory rate, and may be at least partially dependent upon the mode of ventilation…) based on an airflow measurement, a pressure measurement, an oxygen measurement, and/or a carbon dioxide measurement received from the at least one sensor (Paragraph 0022-0024-- the sensors 48 may be pressure sensors, flow sensors, electroencephalogy (EEG) sensors, neural sensors, and/or optical sensors. Additionally, the sensors 48 may generate signals related to certain physiological parameters, such as pressure and flow, which may be used by the processor 38 to derive other physiological parameters…; paragraph 0050-- The data relating to the patient's condition may be collected by the ventilation system 10 and/or one or more external medical devices (e.g., a pulse oximeter, an electrocardiography device, an end-tidal carbon dioxide (EtCo.sub.2) monitor, and/or an electroencephalogy (EEG) device)).
Regarding claim 12, Covidien teaches the ventilation monitoring system of claim 11. Covidien additionally discloses wherein the instructions of the non- transitory computer-readable medium, when executed by the processor, further cause the processor to determine that the ventilation signal corresponds to patient ventilator asynchrony in response to determining that the current mode of ventilation and associated ventilator settings are not within a predetermined limit (Paragraph 0025-0035-- a double-triggering event may result from a patient cough, a patient sigh, a patient yawn, inappropriate ventilator settings (e.g., inspiratory time, inhaled tidal volume, and/or respiratory rate))… the method 80 may include determining whether a frequency of double-triggering is above a respective double-triggering frequency threshold (block 92)… the ventilator 12 and/or the accessory device 56 may direct the caregiver's attention to the ventilator 12 and/or the accessory device 56, so that the caregiver may be aware of the severity of the patient's double-triggering and may consider actions to reduce the frequency of double-triggering).
Regarding claim 13, Covidien teaches the ventilation monitoring system of claim 12. Covidien additionally discloses wherein the instructions of the non- transitory computer-readable medium, when executed by the processor, further cause the processor to generate an alert indicating a presence of patient ventilator asynchrony (Paragraph 0025-0035-- the processor 38 may cause the display 52 and/or a display of the accessory device 56 to display a visual indication, which may be textual, graphical, or any other suitable indication. Various embodiments of the indication of the frequency of double-triggering will be described in more detail below with respect to FIGS. 7-10. Additionally or alternatively, the processor 38 may cause the speaker 54 and/or a speaker of the accessory device 56 to provide an audible indication, such as an alarm or a beep).
Regarding claim 14, Covidien teaches the ventilation monitoring system of claim 1. Covidien additionally discloses wherein the at least one sensor comprises an airflow meter, a pressure sensor, an oxygen sensor, a carbon dioxide sensor, a temperature sensor, and/or a humidity sensor (Paragraph 0022-0024-- the sensors 48 may be pressure sensors, flow sensors, electroencephalogy (EEG) sensors, neural sensors, and/or optical sensors. Additionally, the sensors 48 may generate signals related to certain physiological parameters, such as pressure and flow, which may be used by the processor 38 to derive other physiological parameters…; paragraph 0050-- The data relating to the patient's condition may be collected by the ventilation system 10 and/or one or more external medical devices (e.g., a pulse oximeter, an electrocardiography device, an end-tidal carbon dioxide (EtCo.sub.2) monitor, and/or an electroencephalogy (EEG) device)).
Regarding claim 15, Covidien teaches the ventilation monitoring system of claim 1. Covidien additionally discloses wherein the instructions of the non- transitory computer-readable medium, when executed by the processor, further cause the processor to generate a visual representation of the ventilation signal on a display (Paragraph 0025-0040-- the display 52 may display ventilator settings 124, calculated and/or derived physiological characteristics 126, a graph 128 of the pressure of the patient's respiratory circuit over time, and a graph 134 of the flow of the patient's respiratory circuit over time).
Regarding claim 16, Covidien teaches the ventilation monitoring system of claim 1. Covidien additionally discloses wherein the processor determines the presence of the at least one clinical artifact in the ventilation signal at least partly based on a measured pressure and/or flow waveforms (Paragraph 0022-0024-- the sensors 48 may be pressure sensors, flow sensors, electroencephalogy (EEG) sensors, neural sensors, and/or optical sensors. Additionally, the sensors 48 may generate signals related to certain physiological parameters, such as pressure and flow, which may be used by the processor 38 to derive other physiological parameters…), and wherein the at least one clinical artifact comprises at least one suction event during the ventilation of the patient, closed in-line suctioning of secretions through an endotracheal tube, at least one cough by the patient during the ventilation of the patient, and/or at least one cough morphology resembling patient ventilator asynchrony (Paragraph 0029-0033, 0051--a double-triggering event may occur due to a cough, sigh, or yawn… an isolated double-triggering event or a few intermittent double-triggering events may not necessarily indicate that the patient may benefit from an adjustment in ventilator settings and/or a different ventilator operating mode…).
Regarding claim 17, Covidien discloses a method of monitoring ventilation of a patient (Paragraph 0017-0019), the method comprising:
monitoring a ventilation signal, wherein the ventilation signal is at least partly based on at least one measurement from at least one sensor in fluid communication with airflows exchanged with lungs of the patient during ventilation of the patient (Paragraph 0022-0024-- the processor 38 may receive information from one or more sensors 48 of the ventilation system 10… sensors 48 located within the ventilator 12, such as within the inspiratory and the expiratory modules 26 and 28. Additionally, sensors 48 may be disposed about the respiratory circuit 14. In certain embodiments, inspiratory, expiratory, and patient conduits 16, 18, and 20 and the Y-connector 22 may each include one or more sensors 48. Additionally, it may be desirable to obtain measurements near the lungs and/or near the diaphragm of the patient. As such, one or more sensors 48 may be located within or disposed about the patient interface 24); and
determining whether at least one clinical artifact is present in the ventilation signal (Paragraph 0027-0033-- the processor 38 may detect a decrease in pressure and/or flow in the patient's airway… the processor 38 may determine that a double-triggering event occurred if the exhaled tidal volume is less than the threshold volume. Moreover, the processor 38 may be configured to monitor other parameters to detect double-triggering events, such as the expiratory time or the ratio of the exhaled tidal volume with respect to the inhaled tidal volume…A zero millimeter threshold may identify double-triggering events that may be caused by inappropriate ventilator settings, rather than coughs, sighs, and yawns. For example, the patient may transition to expiration without triggering a stacked breath, but the patient may cough, sigh, or yawn during the expiratory period, which may trigger a stacked breath. As such, this double-triggering event may not indicate that the patient may benefit from an adjustment in ventilator settings. In contrast, an exhaled tidal volume that is approximately equal to zero millimeters may indicate that the patient did not expire between the two breaths. Rather, it may indicate that the patient continued to inspire (e.g., to achieve a greater inhaled tidal volume and/or a longer inspiratory time), thus, triggering a stacked breath.).
Regarding claim 20, Covidien teaches the method of claim 17. Covidien additionally discloses wherein the at least one clinical artifact comprises at least one suction event during the ventilation of the patient, at least one cough by the patient during the ventilation of the patient, at least one cough morphology resembling patient ventilator asynchrony, and/or at least one patient-ventilator disconnect event (Paragraph 0029-0033, 0051--a double-triggering event may occur due to a cough, sigh, or yawn… an isolated double-triggering event or a few intermittent double-triggering events may not necessarily indicate that the patient may benefit from an adjustment in ventilator settings and/or a different ventilator operating mode…).
Regarding claim 21, Covidien teaches the method of claim 17. Covidien additionally discloses wherein the ventilation signal is indicative of a current mode of ventilation and associated ventilator settings (Paragraph 0025-0026-- Additionally, the inspiratory and expiratory modules 26 and 28 may be configured to terminate the delivered breath and transition to expiration based at least in part upon a preset inspiratory time, inhaled tidal volume, and/or respiratory rate, and may be at least partially dependent upon the mode of ventilation…) based on an airflow measurement, a pressure measurement, an oxygen measurement, and/or a carbon dioxide measurement received from the at least one sensor (Paragraph 0022-0024-- the sensors 48 may be pressure sensors, flow sensors, electroencephalogy (EEG) sensors, neural sensors, and/or optical sensors. Additionally, the sensors 48 may generate signals related to certain physiological parameters, such as pressure and flow, which may be used by the processor 38 to derive other physiological parameters…; paragraph 0050-- The data relating to the patient's condition may be collected by the ventilation system 10 and/or one or more external medical devices (e.g., a pulse oximeter, an electrocardiography device, an end-tidal carbon dioxide (EtCo.sub.2) monitor, and/or an electroencephalogy (EEG) device)).
Regarding claim 22, Covidien teaches the method of claim 17. Covidien additionally discloses wherein the determination of whether the at least one clinical artifact in the ventilation signal at least partly based on a measured pressure and/or flow waveforms (Paragraph 0022-0024-- the sensors 48 may be pressure sensors, flow sensors, electroencephalogy (EEG) sensors, neural sensors, and/or optical sensors. Additionally, the sensors 48 may generate signals related to certain physiological parameters, such as pressure and flow, which may be used by the processor 38 to derive other physiological parameters…), and wherein the at least one clinical artifact comprises at least one suction event during the ventilation of the patient, closed in-line suctioning of secretions through an endotracheal tube, at least one cough by the patient during the ventilation of the patient, and/or at least one cough morphology resembling patient ventilator asynchrony (Paragraph 0029-0033, 0051--a double-triggering event may occur due to a cough, sigh, or yawn… an isolated double-triggering event or a few intermittent double-triggering events may not necessarily indicate that the patient may benefit from an adjustment in ventilator settings and/or a different ventilator operating mode…).
Claim(s) 1-2, 14, and 16-18 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Freeman (WO 2012162048 A1).
Regarding claim 1, Freeman teaches a ventilation monitoring system (Paragraph 0002, 0005-0006—systems and methods for regarding ventilation of a patient…systems and techniques that may be used to monitor ventilation to a patient) comprising:
a processor (Paragraph 0006, 0015-0023, 0188-0189—a processor arranged to receive data generated by the airflow sensor and the pressure sensor…); and
a non-transitory computer-readable medium having instructions that, when executed by the processor, cause the processor to:
monitor a ventilation signal, wherein the ventilation signal is at least partly based on at least one measurement from at least one sensor in fluid communication with airflows exchanged with lungs of a patient during ventilation of the patient (Paragraph 0082-0084; Paragraph 0188-0193-- ventilation data including pressure and volume are received from the ventilation device (e.g., using sensor devices described herein); paragraph 0048, 0058, 00200-00201-- the system generates an estimate of a thoracic state impedance based on an estimate of lung volume. The estimate of lung volume can be determined using one or more of the processes described herein); and
determine whether at least one clinical artifact is present in the ventilation signal (Paragraph 00200-00202-- the system can filter ventilation- induced artifacts in the transthoracic impedance signal).
Regarding claim 2, Freeman teaches the ventilation monitoring system of claim 1. Freeman additionally teaches wherein the instructions of the non- transitory computer-readable medium, when executed by the processor, further cause the processor to filter out the at least one clinical artifact from the ventilation signal (Paragraph 0200-0201-- The estimate of thoracic state impedance can be provided to an adaptive filter and the system can filter ventilation- induced artifacts in the transthoracic impedance signal to provide a more accurate estimate of the impedance changes induced by cardiac output for the impedance cardiography (ICG) signal).
Regarding claim 14, Freeman teaches the ventilation monitoring system of claim 1. Freeman additionally teaches wherein the at least one sensor comprises an airflow meter, a pressure sensor, an oxygen sensor, a carbon dioxide sensor, a temperature sensor, and/or a humidity sensor (Paragraph 0082-0084; Paragraph 0188-0193-- ventilation data including pressure and volume are received from the ventilation device (e.g., using sensor devices described herein)).
Regarding claim 17, Freeman teaches a method of monitoring ventilation of a patient (Paragraph 0002, 0005-0006—systems and methods for regarding ventilation of a patient…systems and techniques that may be used to monitor ventilation to a patient) the method comprising:
monitoring a ventilation signal, wherein the ventilation signal is at least partly based on at least one measurement from at least one sensor in fluid communication with airflows exchanged with lungs of the patient during ventilation of the patient (Paragraph 0082-0084; Paragraph 0188-0193-- ventilation data including pressure and volume are received from the ventilation device (e.g., using sensor devices described herein); paragraph 0048, 0058, 00200-00201-- the system generates an estimate of a thoracic state impedance based on an estimate of lung volume. The estimate of lung volume can be determined using one or more of the processes described herein); and
determining whether at least one clinical artifact is present in the ventilation signal (Paragraph 00200-00202-- the system can filter ventilation- induced artifacts in the transthoracic impedance signal).
Regarding claim 18, Freeman teaches the method of claim 17. Freeman additionally teaches further comprising filtering out the at least one clinical artifact from the ventilation signal (Paragraph 0200-0201-- The estimate of thoracic state impedance can be provided to an adaptive filter and the system can filter ventilation- induced artifacts in the transthoracic impedance signal to provide a more accurate estimate of the impedance changes induced by cardiac output for the impedance cardiography (ICG) signal).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 2 and 18-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Milne in view of Mulqueeny (US 20120037159 A1).
Regarding claim 2, Milne teaches the ventilation monitoring system of claim 1. However, Milne does not explicitly disclose wherein the instructions of the non- transitory computer-readable medium, when executed by the processor, further cause the processor to filter out the at least one clinical artifact from the ventilation signal.
Mulqueeny, in the same field of endeavor of systems and methods for detecting conditions such as asynchrony associated with a ventilator (Abstract), discloses wherein the instructions of the non- transitory computer-readable medium, when executed by the processor, further cause the processor to filter out the at least one clinical artifact from the ventilation signal (Paragraph 0074-0080, 0173-- Respiratory Mechanics based features for each breath may also be determined… Expiratory flow morphology based features may also be determined. Asynchronies may be characterized by irregularities or perturbations on the pressure and flow signals. To identify these during expiration, significant deviations of the flow curve may be derived from an approximated "normal" expiratory shape. A segmented moving average filter with time constant, such as about 0.1 seconds, can be applied to a flow signal separately for each respiratory phase; paragraph 0257-- The desire for a good fit is to achieve an expiratory breath without expiratory effort or other spurious artefacts, such that the flow waveform follows an exponential decay… One way to accomplish this may be to implement a median filter, such as one with a width of about 15, such that the median values of the fitted mechanics parameters from the last number breaths (e.g., about 15) can be taken to represent the expiratory breaths with more regular exponential decay.).
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the system of Milne with the filtering of Mulqueeny in order to predictably improve the ability of the system to accurately measure respiratory features of the breaths of a user by providing means of excluding artifacts in the signal such as clinical artifacts which do not reflect the normal respiratory features of the user’s breaths.
Regarding claim 18, Milne teaches the method of claim 17. However, Milne does not explicitly disclose further comprising filtering out the at least one clinical artifact from the ventilation signal.
Mulqueeny, in the same field of endeavor of systems and methods for detecting conditions such as asynchrony associated with a ventilator (Abstract), discloses further comprising filtering out the at least one clinical artifact from the ventilation signal (Paragraph 0074-0080, 0173-- Respiratory Mechanics based features for each breath may also be determined… Expiratory flow morphology based features may also be determined. Asynchronies may be characterized by irregularities or perturbations on the pressure and flow signals. To identify these during expiration, significant deviations of the flow curve may be derived from an approximated "normal" expiratory shape. A segmented moving average filter with time constant, such as about 0.1 seconds, can be applied to a flow signal separately for each respiratory phase; paragraph 0257-- The desire for a good fit is to achieve an expiratory breath without expiratory effort or other spurious artefacts, such that the flow waveform follows an exponential decay… One way to accomplish this may be to implement a median filter, such as one with a width of about 15, such that the median values of the fitted mechanics parameters from the last number breaths (e.g., about 15) can be taken to represent the expiratory breaths with more regular exponential decay.).
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the method of Milne with the filtering of Mulqueeny in order to predictably improve the ability of the method to accurately measure respiratory features of the breaths of a user by providing means of excluding artifacts in the signal such as clinical artifacts which do not reflect the normal respiratory features of the user’s breaths.
Regarding claim 19, the combination of Milne and Mulqueeny teaches the method of claim 18. Milne additionally teaches wherein the at least one clinical artifact corresponds to a ventilation event other than patient ventilator asynchrony (Paragraph 0136-0138-- Ventilator 202 may further include an ineffective effort detection module 224a. An ineffective effort, as used herein, is a patient inspiratory effort that does not result in the delivery of a breath by the ventilator. An ineffective effort occurs when the ventilator does not detect a patient inspiratory expiratory effort. The ventilator may not detect the inspiratory because the trigger threshold is set too high and/or because the inspiratory is below the minimum trigger detection level for the trigger type; paragraph 0154-0174-- enable leak compensation… check patient circuit for condensate… check for causes of increased resistance…).
Claim(s) 7-8, 16, 20, and 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Milne in view of Covidien.
Regarding claim 7, Milne teaches the ventilation monitoring system of claim 1. Milne additionally discloses determining a double trigger asynchrony of the ventilation (Paragraph 0134-0135-- Asynchrony is detected by the asynchrony module 224 when an ineffective effort, an auto-trigger, a late trigger, an early cycle, a late cycle, a double trigger, an inadequate flow, and/or a high tidal volume is detected). However, Milne fails to explicitly teach wherein the at least one clinical artifact comprises at least one cough by the patient during the ventilation of the patient.
Covidien, in the same field of endeavor of a system for monitoring the ventilation of a patient, discloses wherein the at least one clinical artifact comprises at least one cough by the patient during the ventilation of the patient (Paragraph 0029-0033, 0051--a double-triggering event may occur due to a cough, sigh, or yawn… an isolated double-triggering event or a few intermittent double-triggering events may not necessarily indicate that the patient may benefit from an adjustment in ventilator settings and/or a different ventilator operating mode…).
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the system of Milne, which discloses detecting a double trigger asynchrony, with the teachings of Covidien which disclose detecting at least one cough by the patient in the form of a double-triggering event in the ventilation signal in order to predictably improve the ability of the system to detect additional causes of clinical artifacts and distinguish between these causes and ventilation asynchrony.
Regarding claim 8, Milne teaches the ventilation monitoring system of claim 1. Milne additionally discloses determining a double trigger asynchrony of the ventilation (Paragraph 0134-0135-- Asynchrony is detected by the asynchrony module 224 when an ineffective effort, an auto-trigger, a late trigger, an early cycle, a late cycle, a double trigger, an inadequate flow, and/or a high tidal volume is detected). However, Milne fails to explicitly teach wherein the at least one clinical artifact comprises at least one cough by the patient during the ventilation of the patient.
Covidien, in the same field of endeavor of a system for monitoring the ventilation of a patient, discloses wherein the at least one clinical artifact comprises at least one cough morphology resembling patient ventilator asynchrony (Paragraph 0029-0033, 0051--a double-triggering event may occur due to a cough, sigh, or yawn… an isolated double-triggering event or a few intermittent double-triggering events may not necessarily indicate that the patient may benefit from an adjustment in ventilator settings and/or a different ventilator operating mode…).
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the system of Milne, which discloses detecting a double trigger asynchrony, with the teachings of Covidien which disclose detecting at least one cough morphology resembling patient ventilator asynchrony by the patient in the form of a double-triggering event in the ventilation signal in order to predictably improve the ability of the system to detect additional causes of clinical artifacts and distinguish between these causes and ventilation asynchrony.
Regarding claim 16, Milne teaches the ventilation monitoring system of claim 1. Milne additionally discloses determining a double trigger asynchrony of the ventilation (Paragraph 0134-0135-- Asynchrony is detected by the asynchrony module 224 when an ineffective effort, an auto-trigger, a late trigger, an early cycle, a late cycle, a double trigger, an inadequate flow, and/or a high tidal volume is detected). However, Milne fails to explicitly teach wherein the processor determines the presence of the at least one clinical artifact in the ventilation signal at least partly based on a measured pressure and/or flow waveforms, and wherein the at least one clinical artifact comprises at least one suction event during the ventilation of the patient, closed in-line suctioning of secretions through an endotracheal tube, at least one cough by the patient during the ventilation of the patient, and/or at least one cough morphology resembling patient ventilator asynchrony.
Covidien, in the same field of endeavor of a system for monitoring the ventilation of a patient, discloses wherein the processor determines the presence of the at least one clinical artifact in the ventilation signal at least partly based on a measured pressure and/or flow waveforms (Paragraph 0022-0024-- the sensors 48 may be pressure sensors, flow sensors, electroencephalogy (EEG) sensors, neural sensors, and/or optical sensors. Additionally, the sensors 48 may generate signals related to certain physiological parameters, such as pressure and flow, which may be used by the processor 38 to derive other physiological parameters…), and wherein the at least one clinical artifact comprises at least one suction event during the ventilation of the patient, closed in-line suctioning of secretions through an endotracheal tube, at least one cough by the patient during the ventilation of the patient, and/or at least one cough morphology resembling patient ventilator asynchrony (Paragraph 0029-0033, 0051--a double-triggering event may occur due to a cough, sigh, or yawn… an isolated double-triggering event or a few intermittent double-triggering events may not necessarily indicate that the patient may benefit from an adjustment in ventilator settings and/or a different ventilator operating mode…).
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the system of Milne, which discloses detecting a double trigger asynchrony, with the teachings of Covidien which disclose detecting at least one cough or cough morphology resembling patient ventilator asynchrony by the patient in the form of a double-triggering event in the ventilation signal in order to predictably improve the ability of the system to detect additional causes of clinical artifacts and distinguish between these causes and ventilation asynchrony.
Regarding claim 22, Milne teaches the method of claim 17. Milne additionally discloses determining a double trigger asynchrony of the ventilation (Paragraph 0134-0135-- Asynchrony is detected by the asynchrony module 224 when an ineffective effort, an auto-trigger, a late trigger, an early cycle, a late cycle, a double trigger, an inadequate flow, and/or a high tidal volume is detected). However, Milne fails to explicitly teach wherein the determination of whether the at least one clinical artifact is present in the ventilation signal is at least partly based on a measured pressure and/or flow waveforms, and wherein the at least one clinical artifact comprises at least one suction event during the ventilation of the patient, closed in-line suctioning of secretions through an endotracheal tube, at least one cough by the patient during the ventilation of the patient, and/or at least one cough morphology resembling patient ventilator asynchrony.
Covidien, in the same field of endeavor of a system for monitoring the ventilation of a patient, discloses wherein the determination of whether the at least one clinical artifact is present in the ventilation signal is at least partly based on a measured pressure and/or flow waveforms (Paragraph 0022-0024-- the sensors 48 may be pressure sensors, flow sensors, electroencephalogy (EEG) sensors, neural sensors, and/or optical sensors. Additionally, the sensors 48 may generate signals related to certain physiological parameters, such as pressure and flow, which may be used by the processor 38 to derive other physiological parameters…), and wherein the at least one clinical artifact comprises at least one suction event during the ventilation of the patient, closed in-line suctioning of secretions through an endotracheal tube, at least one cough by the patient during the ventilation of the patient, and/or at least one cough morphology resembling patient ventilator asynchrony (Paragraph 0029-0033, 0051--a double-triggering event may occur due to a cough, sigh, or yawn… an isolated double-triggering event or a few intermittent double-triggering events may not necessarily indicate that the patient may benefit from an adjustment in ventilator settings and/or a different ventilator operating mode…).
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the system of Milne, which discloses detecting a double trigger asynchrony, with the teachings of Covidien which disclose detecting at least one cough or cough morphology resembling patient ventilator asynchrony by the patient in the form of a double-triggering event in the ventilation signal in order to predictably improve the ability of the system to detect additional causes of clinical artifacts and distinguish between these causes and ventilation asynchrony.
Conclusion
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/ANNA ROBERTS/Examiner, Art Unit 3791
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