DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Objections
Claims 7, 9, 17-21, and 24 are objected to because of the following informalities:
Claim 7, line 3, “one or more parameters” should read “the one or more parameters”
Claim 9, line 3, “one or more parameters” should read “the one or more parameters”
Claim 17, lines 2-3, “one or more breathing parameter ratios and/or one or more additional breathing parameters” should read “the one or more breathing parameter ratios and/or the one or more additional breathing parameters”
Claim 18, lines 2-3, “one or more breathing parameter ratios and/or breathing parameters” should read “the one or more breathing parameter ratios and/or the breathing parameter data”
Claim 19, lines 3-4, “one or more breathing parameter ratios and/or breathing parameters” should read “the one or more breathing parameter ratios and/or the breathing parameter data”
Claim 20, lines 2-3, it is recommended to change “one or more breathing parameter ratios and/or breathing parameters” to “the one or more breathing parameter ratios and/or the breathing parameter data”
Claim 21, line 3-4, “breathing parameters” should read “the breathing parameter data”
Claim 24, line 3; “one or more flow rate sensors” should read “the one or more flow rate sensors”
Appropriate correction is required.
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, 5-14, 17-20, and 22-24 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Each of Claims 1, 5-14, 17-20, and 22-24 has been analyzed to determine whether it is directed to any judicial exceptions.
Step 2A, Prong 1
Each of Claims 1, 5-14, 17-20, and 22-24 recites at least one step or instruction for a respiration treatment apparatus to process flow data to make a series of calculation for one or more breathing parameter ratios, which is grouped as a mental process under the 2019 PEG or a certain method of organizing human activity under the 2019 PEG. Accordingly, each of Claims 1, 5-14, 17-20, and 22-24 recites an abstract idea.
Specifically, Claim 1 recites
a respiratory apparatus (additional element) that is configured to provide a flow of gases to a user patient for respiratory therapy comprising:
a flow generator that is operable to generate a flow of gases (additional element);
a controller that is operatively connected to the flow generator and operable to control a flow rate of the flow of gases by controlling the flow generator (additional element),
wherein the controller is configured during operation to:
receive flow rate data indicative of or representing the flow rate of the flow of gases (observation, judgment or evaluation, which is grouped as a mental process under the 2019 PEG);
process the flow rate data to extract or generate breathing parameter data indicative of or representing a patient's breathing or respiration from the flow rate data (observation, judgment or evaluation, which is grouped as a mental process under the 2019 PEG); and
process the breathing parameter data to calculate one or more breathing parameter ratios representative of a ratio between inspiration time and/or expiration time to total respiration time for a patient's breathing cycle (observation, judgment or evaluation, which is grouped as a mental process under the 2019 PEG).
Accordingly, as indicated above, each of the above-identified claims recites an abstract idea.
Further, dependent Claims 5-14, 17-20, and 22-24 are merely include limitations that either further define the abstract idea (and thus don’t make the abstract idea any less abstract) or amount to no more than generally linking the use of the abstract idea to a particular technological environment or field of use because they’re merely incidental or token additions to the claims that do not alter or affect how the process steps are performed.
Step 2A, Prong 2
The above-identified abstract idea in each of independent Claim 1 and their respective dependent Claims 5-14, 17-20, and 22-24) is not integrated into a practical application under 2019 PEG because the additional elements (identified above in independent Claim 1), either alone or in combination, generally link the use of the above-identified abstract idea to a particular technological environment or field of use. More specifically, the additional elements of:
Respiration apparatus, flow generator, and a controller
as recited in independent Claim 1 and its dependent claims are generically recited structural/computer elements in independent Claim 1 (and their respective dependent claims) which do not improve the functioning of a computer, or any other technology or technical field. Nor do these above-identified additional elements serve to apply the above-identified abstract idea with, or by use of, a particular machine, effect a transformation or apply or use the above-identified abstract idea in some other meaningful way beyond generally linking the use thereof to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception. Furthermore, the above-identified additional elements do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a computer. For at least these reasons, the abstract idea identified above in independent Claim 1 (and their respective dependent claims) is not integrated into a practical application under 2019 PEG.
Moreover, the above-identified abstract idea is not integrated into a practical application under 2019 PEG because the claimed method and system merely implements the above-identified abstract idea (e.g., mental process and certain method of organizing human activity) using rules (e.g., computer instructions) executed by a computer (controller as claimed). In other words, these claims are merely directed to an abstract idea with additional generic computer elements which do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a computer. Additionally, Applicant’s specification does not include any discussion of how the claimed invention provides a technical improvement realized by these claims over the prior art or any explanation of a technical problem having an unconventional technical solution that is expressed in these claims. That is, like Affinity Labs of Tex. v. DirecTV, LLC, the specification fails to provide sufficient details regarding the manner in which the claimed invention accomplishes any technical improvement or solution. Thus, for these additional reasons, the abstract idea identified above in independent Claim 1 (and their respective dependent claims) is not integrated into a practical application under the 2019 PEG.
Accordingly, independent Claim 1 (and their respective dependent claims) are each directed to an abstract idea under 2019 PEG.
Step 2B
None of Claims 1, 5-14, 17-20, and 22-24 include additional elements that are sufficient to amount to significantly more than the abstract idea for at least the following reasons.
These claims require the additional elements of:
Respiration apparatus, flow generator, and a controller as recited in independent Claim 1 and its dependent claims.
The above-identified additional elements are generically claimed computer components which enable the above-identified abstract idea(s) to be conducted by performing the basic functions of automating mental tasks. The courts have recognized such computer functions as well understood, routine, and conventional functions when claimed in a merely generic manner (e.g., at a high level of generality) or as insignificant extra-solution activity. See, Versata Dev. Group, Inc. v. SAP Am., Inc. , 793 F.3d 1306, 1334, 115 USPQ2d 1681, 1701 (Fed. Cir. 2015); and OIP Techs., 788 F.3d at 1363, 115 USPQ2d at 1092-93.
Per Applicant’s specification, the controller 19 can include one or more hardware and/or software processors and can be configured or programmed to control the component of the system and the system 10 can include a wired connection, for example, using cables or wires, to enable the controller 19 to receive data signals from the operation sensors and/or to control the various components of the apparatus 10 (fig. 1 and 19b, [0129] and [0141] of publication).
Accordingly, in light of Applicant’s specification, the claimed term “controller” is reasonably construed as a generic computing device. Like SAP America vs Investpic, LLC (Federal Circuit 2018), it is clear, from the claims themselves and the specification, that these limitations require no improved computer resources, just already available computers, with their already available basic functions, to use as tools in executing the claimed process.
Furthermore, Applicant’s specification does not describe any special programming or algorithms required for the controller. This lack of disclosure is acceptable under 35 U.S.C. §112(a) since this hardware performs non-specialized functions known by those of ordinary skill in the computer arts. By omitting any specialized programming or algorithms, Applicant's specification essentially admits that this hardware is conventional and performs well understood, routine and conventional activities in the computer industry or arts. In other words, Applicant’s specification demonstrates the well-understood, routine, conventional nature of the above-identified additional elements because it describes these additional elements in a manner that indicates that the additional elements are sufficiently well-known that the specification does not need to describe the particulars of such additional elements to satisfy 35 U.S.C. § 112(a) (see Berkheimer memo from April 19, 2018, (III)(A)(1) on page 3). Adding hardware that performs “‘well understood, routine, conventional activities’ previously known to the industry” will not make claims patent-eligible (TLI Communications).
The recitation of the above-identified additional limitations in Claims 1, 5-14, 17-20, and 22-24 amounts to mere instructions to implement the abstract idea on a computer. Simply using a computer or other machinery in its ordinary capacity for economic or other tasks (e.g., to receive, store, or transmit data) or simply adding a general purpose computer or computer components after the fact to an abstract idea (e.g., a fundamental economic practice or mathematical equation) does not provide significantly more. See Affinity Labs v. DirecTV, 838 F.3d 1253, 1262, 120 USPQ2d 1201, 1207 (Fed. Cir. 2016) (cellular telephone); and TLI Communications LLC v. AV Auto, LLC, 823 F.3d 607, 613, 118 USPQ2d 1744, 1748 (Fed. Cir. 2016) (computer server and telephone unit). Moreover, implementing an abstract idea on a generic computer, does not add significantly more, similar to how the recitation of the computer in the claim in Alice amounted to mere instructions to apply the abstract idea of intermediated settlement on a generic computer.
A claim that purports to improve computer capabilities or to improve an existing technology may provide significantly more. McRO, Inc. v. Bandai Namco Games Am. Inc., 837 F.3d 1299, 1314-15, 120 USPQ2d 1091, 1101-02 (Fed. Cir. 2016); and Enfish, LLC v. Microsoft Corp., 822 F.3d 1327, 1335-36, 118 USPQ2d 1684, 1688-89 (Fed. Cir. 2016). However, a technical explanation as to how to implement the invention should be present in the specification for any assertion that the invention improves upon conventional functioning of a computer, or upon conventional technology or technological processes. That is, the disclosure must provide sufficient details such that one of ordinary skill in the art would recognize the claimed invention as providing an improvement. Here, Applicant’s specification does not include any discussion of how the claimed invention provides a technical improvement realized by these claims over the prior art or any explanation of a technical problem having an unconventional technical solution that is expressed in these claims. Instead, as in Affinity Labs of Tex. v. DirecTV, LLC 838 F.3d 1253, 1263-64, 120 USPQ2d 1201, 1207-08 (Fed. Cir. 2016), the specification fails to provide sufficient details regarding the manner in which the claimed invention accomplishes any technical improvement or solution.
For at least the above reasons, the apparatus of Claims 1, 5-14, 17-20, and 22-24 are directed to applying an abstract idea (e.g., mental process or certain method of organizing human activity) on a general purpose computer without (i) improving the performance of the computer itself (as in McRO, Bascom and Enfish), or (ii) providing a technical solution to a problem in a technical field (as in DDR). In other words, none of Claims 1, 5-14, 17-20, and 22-24 provide meaningful limitations to transform the abstract idea into a patent eligible application of the abstract idea such that these claims amount to significantly more than the abstract idea itself.
Taking the additional elements individually and in combination, the additional elements do not provide significantly more. Specifically, when viewed individually, the above-identified additional elements in independent Claims 1 (and their dependent claims) do not add significantly more because they are simply an attempt to limit the abstract idea to a particular technological environment. That is, neither the general computer elements nor any other additional element adds meaningful limitations to the abstract idea because these additional elements represent insignificant extra-solution activity. When viewed as a combination, these above-identified additional elements simply instruct the practitioner to implement the claimed functions with well-understood, routine and conventional activity specified at a high level of generality in a particular technological environment. As such, there is no inventive concept sufficient to transform the claimed subject matter into a patent-eligible application. As such, the above-identified additional elements, when viewed as whole, do not provide meaningful limitations to transform the abstract idea into a patent eligible application of the abstract idea such that the claims amount to significantly more than the abstract idea itself. Thus, Claims 1, 5-14, 17-20, and 22-24 merely apply an abstract idea to a computer and do not (i) improve the performance of the computer itself (as in Bascom and Enfish), or (ii) provide a technical solution to a problem in a technical field (as in DDR).
Therefore, none of the Claims 1, 5-14, 17-20, and 22-24 amounts to significantly more than the abstract idea itself.
Accordingly, Claims 1, 5-14, 17-20, and 22-24 are not patent eligible and rejected under 35 U.S.C. 101 as being directed to abstract ideas implemented on a generic computer in view of the Supreme Court Decision in Alice Corporation Pty. Ltd. v. CLS Bank International, et al. and 2019 PEG.
It is recommended to further add limitation similar to claim 21 such as “wherein the controller is configured to modify or alter operation of the flow generator based on the one or more breathing parameter ratios and/or the breathing parameter data” which provides a closed-loop to the calculations; therefore, integrating it into practical application
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, 5, 10-14, 17, 18, and 21 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mulqueeny (US 20120037159).
Regarding claim 1, Mulqueeny discloses
a respiratory apparatus that is configured to provide a flow of gases to a user patient for respiratory therapy (see fig. 11; respiratory treatment apparatus 1102 with servo controlled blower 1104 is connected to mask 1108 to deliver breathable air /gas to and/or from the patient; [0289] and [0290]) comprising:
a flow generator that is operable to generate a flow of gases (fig. 11; servo controlled blower 1104 adjusts the flow delivered to the patient interface 1108; [0289]-[0292]);
a controller that is operatively connected to the flow generator and operable to control a flow rate of the flow of gases by controlling the flow generator (fig. 11; controller 1112 generates blower control signals based on sensor signals, flow signals f(t) and pressure signals p(t); [0289]-[0292]),
wherein the controller is configured during operation to:
receive flow rate data indicative of or representing the flow rate of the flow of gases (figs. 11-12; flow sensor generates a signal representative of patient’s respiratory flow; controller 1112 receives sensor signals such as flow f(t) and pressure p(t); [0289]-[0292]);
process the flow rate data to extract or generate breathing parameter data indicative of or representing a patient's breathing or respiration from the flow rate data (figs. 3-9 and 12-19; the controller synchronizes treatment with patient’s respiration and is made in conjunction of a detection of a state of a patient respiration such as by analysis of the flow signals and by use of asynchrony detector; [0045]-[0051] and [0292]); and
process the breathing parameter data (figs. 3-9 and 12-19; “detection values may include: respiratory rate based features, volume based features, respiratory mechanics based features, expiratory flow morphology based features, power based power based features, etc., derivable with pressure and/or flow data and detection variables such as RR breath, RR ratio, IE ratio, Vol.sub.I, Vol.sub.E, breath Leak, Vol ratio, PEEPii, R.sub.i, C.sub.i, Tau.sub.i, PEEPie, Re, Ce, Tau.sub.e, InterpMinima, InterpMinima-2/3, PW linear approx. power, PW vol deviation, PW dist. flow maxmin, and PW distance ratio”; [0064]) to calculate one or more breathing parameter ratios representative of a ratio (such values can be calculated based on sensor signals on a breath by breath basis; [0063]-[0064]) between inspiration time and/or expiration time to total respiration time for a patient's breathing cycle (figs. 3-9 and 12-19 and Table II on page 5; the feature set of detection values may be two or more of features of a group of features consisting of (a) a respiratory rate based feature, respiratory rate may be determined as the ratio of inspiratory time for the breath to the period of the breath; [0017] and [0064]-[0068]).
Regarding claim 5, Mulqueeny further discloses
a respiratory apparatus (respiration treatment apparatus 1102) of Claim 1,
wherein the controller is configured to process the breathing parameter data (figs. 3-9 and 12-19; controller 1112 with asynchrony detector processes sensor signal data to calculate detection values (see claim 1 above); [0064]) to generate the one or more breathing parameter ratios (figs. 3-9 and 12-19 and Table II on page 5; the feature set of detection values may be two or more of features of a group of features consisting of (a) a respiratory rate based feature, respiratory rate may be determined as the ratio of inspiratory time for the breath to the period of the breath; [0017] and [0065]-[0068]) by:
fitting a function (see fig. 10; a breath segmentation algorithm/function; [0098]-[0099]) or line (respiratory mechanics based features for each breath may also be determined. For example, mechanics parameters can be calculated for both inspiratory and expiratory phases (denoted by subscript i and e respectively) of each breath by a multiple linear regression fit of pressure, flow and volume data; [0074], see [0064]-[0075]) to a selected portion of the breathing parameter data (see fig. 10 and 13; it is readily understood that the breath segmentation algorithm is applied to a selected portion of the data, [0098]-[0099]; regardless, the processor may be configured to control a comparison of the data of the feature set of detection values (a selected set of detection values of the data) with a set of stored data threshold of the memory, [0009])and
calculating the one or more breathing parameter ratios (figs. 3-9 and 12-19 and Table II on page 5; the feature set of detection values may be two or more of features of a group of features consisting of (a) a respiratory rate based feature, respiratory rate may be determined as the ratio of inspiratory time for the breath to the period of the breath; [0017] and [0064]-[0068]) based at least partly on one or more parameters defining the function or line (fig. 10; segmentation algorithm automatically demarks each breath instance by analyzing the flow and volume signals (shown as "Flow" and "Volume" conditions of FIG. 10) to identify the points in time at the beginning and end of each inspiration, calculates inspiration times based on thresholds (see fig. 10); [0098]-[0099]).
Regarding claim 10, Mulqueeny further discloses
the respiratory apparatus (respiration treatment apparatus 1102) of Claim 1,
the controller is further configured to:
receive or calculate respiratory rate data representing or indicative of [[the ]]a patient's respiratory rate (see figs. 3-9 and 11-19 and Table II on page 5; controller 1112 with asynchrony detection receives signal representative of the patient's respiratory flow (represents respiration rate) from flow sensor and further calculates respiration rate using asynchrony detector; [0291] and [0063]-[0080]), and
calculate one or more additional breathing parameter ratios and/or one or more additional breathing parameters (figs. 3-19 and Table II on page 5; the asynchrony detector of the controller would be capable of calculating additional ratios and breathing parameters as inspiration time for breath to the period of the breath is already calculated [0068], the breath segmentation algorithm also detects expiration states [0098]-[0099], [0112]-[0115], and detection values that are calculated may be one or more of RR breath, RR ratio, IE ratio, Vol.sub.I, Vol.sub.E, breathLeak, Vol ratio, PEEPi.sub.i, R.sub.i, C.sub.i, Tau.sub.i, PEEPi.sub.e, R.sub.e, C.sub.e, Tau.sub.e, (…) and/or expRatio [0064] and [0269]) based on an initially calculated breathing parameter ratio(s) and the respiratory rate data (it would have been readily understood by one of ordinary skill in the art that the controller and asynchrony detector would be able to calculate additional parameters such as expiratory time and additional ratios such as an inspiratory to expiratory ratio or expiratory time to total respiratory time; by using the known ratio of inspiration time over total respiration time (calculated “feature based on the respiratory rate determined as the ratio of inspiratory time for the breath to the period of the breath”, [0064]-[0068]) to calculate expiration time (expiration time = total respiration time – inspiratory time) and then further calculate inspiration to expiration ratio (inspiration time/expiration time) or an expiration time to total respiration time ratio (expiration time/total respiration time)).
Regarding claim 11, Mulqueeny further discloses
the respiratory apparatus (respiration treatment apparatus 1102) of Claim 10,
wherein the one or more additional breathing parameter ratios calculated (see fig. 11 and Table II on page 5; using the known ratio of inspiration time over total respiration time (calculated “feature based on the respiratory rate determined as the ratio of inspiratory time for the breath to the period of the breath”, [0064]-[0068]) to calculate additional ratios) comprise any additional ratio between any combination or permutation of two of the one or more additional breathing parameters: inspiration time, expiration time, and total respiration time (see claim 10 above; calculate expiration time (expiration time = total respiration time – inspiratory time) and then further calculate inspiration to expiration ratio (inspiration time/expiration time) or an expiration time to total respiration time ratio (expiration time/total respiration time).
Regarding claim 12, Mulqueeny further discloses
the respiratory apparatus (respiration treatment apparatus 1102) of Claim 10,_
wherein the one or more additional breathing parameters calculated (the controller and asynchrony detector would be able to calculate additional parameters such as expiratory time; see fig. 11 and Table II on page 5; using the known ratio of inspiration time over total respiration time (calculated “feature based on the respiratory rate determined as the ratio of inspiratory time for the breath to the period of the breath”, [0064]-[0068]) comprise any one or more of: inspiration time, expiration time, and/or total respiration time (see fig. 11 and Table II on page 5; inspiration time and total respiration time are already calculated/known, [0064]-[0068]; see claim 10 above; calculate expiration time (expiration time = total respiration time – inspiratory time)).
Regarding claim 13, Mulqueeny further discloses
the respiratory apparatus (respiration treatment apparatus 1102) of Claim 10,
wherein the respiratory rate data is received or retrieved from a device or sensor (figs. 11-12; flow sensor generates a signal representative of patient’s respiratory flow which is used to calculate respiratory rate based features, [0017] and [0063]-[0080]; controller 1112 receives sensor signals such as flow f(t) and pressure p(t); [0289]-[0292]) operatively connected to the respiratory apparatus (see fig. 11; respiration apparatus 1102 includes sensors 1110 such as pressure sensor and/or flow sensor; [0291]).
Regarding claim 14, Mulqueeny further discloses
the respiratory apparatus (respiration treatment apparatus 1102) of Claim 10,
wherein the controller is configured to calculate the respiratory rate data from the breathing parameter data extracted from the flow rate data (fig. 11 and Table II on page 5; the controller 1112 with the asynchrony detector calculates respiration rate using data of detection values and variables based on sensor signals (analyzing flow signals corresponding to patients flow respiration); [0063]-[0080] and [0291]).
Regarding claim 17, Mulqueeny further discloses
the respiratory apparatus (respiration treatment apparatus 1102) of Claim 10,
wherein the controller is configured to display one or more breathing parameter ratios and/or one or more additional breathing parameters (figs. 3-10 and 12-19; display total respiration, inspiration, and expiration times and ratios; [0063]-[0080] and [0098]-[0099]) on a display (see figs. 12 (shows an example of controller 1112) and 13; detection device 1206 includes a display interface 1210 to output data from the detection methodologies as previously discussed (e.g., asynchrony events and information, etc.; [0298])of the respiratory apparatus (figs. 11-13; controller 1112 is part of the respiration apparatus 1102; [0289]-[0292]).
Regarding claim 18, Mulqueeny further discloses
the respiratory apparatus (respiration treatment apparatus 1102) of Claim 10,
wherein the controller is configured to display (see figs. 12 (shows an example of controller 1112) and 13; detection device 1206 includes a display interface 1210 to output data from the detection methodologies as previously discussed (e.g., asynchrony events and information, etc.; [0298]) one or more breathing parameter ratios and/or breathing parameters (figs. 3-10 and 12-19; display total respiration, inspiration, and expiration times and ratios; [0063]-[0080] and [0098]-[0099]) numerically and/or as a graph, plot or chart (see fig. 13; display interface 1210 output data as results or graphs as described herein such as on a monitor or LCD panel; [0298]).
Regarding claim 21, Mulqueeny further discloses
the respiratory apparatus (respiration treatment apparatus 1102) of Claim 1,
wherein the controller is configured to modify or alter operational and/or therapy settings (figs. 11 and 12; controller 1112 controls flow generation means 1104 to provide synchronized respiratory treatment based on sensor signals and detection values; [0015]-[0020]; [0271] and [0289]-[0292]) based on the one or more breathing parameter ratios and/or breathing parameters (fig. 11; adjustments to respiratory treatment by a ventilator may be automated/modified according to the detected events; [0271] and [0289]-[0292]).
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.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 6-9 are rejected under 35 U.S.C. 103 as being unpatentable over Mulqueeny (US 20120037159) in view of Younes (US 20060278223).
Regarding claim 6, Mulqueeny discloses
a respiratory apparatus (respiration treatment apparatus 1102) of Claim 1,
wherein the controller is configured to process the breathing parameter data (figs. 3-9 and 12-19; controller 1112 with asynchrony detector processes sensor signal data to calculate detection values (see claim 1 above); [0064]) to generate the one or more breathing parameter ratios (figs. 3-9 and 12-19 and Table II on page 5; the feature set of detection values may be two or more of features of a group of features consisting of (a) a respiratory rate based feature, respiratory rate may be determined as the ratio of inspiratory time for the breath to the period of the breath; [0017] and [0065]-[0068]) by:
fitting a function (see fig. 10; a breath segmentation algorithm/function; [0098]-[0099]) or line (respiratory mechanics based features for each breath may also be determined. For example, mechanics parameters can be calculated for both inspiratory and expiratory phases (denoted by subscript i and e respectively) of each breath by a multiple linear regression fit of pressure, flow and volume data; [0074], see [0064]-[0075]) to a selected portion of the breathing parameter data (see fig. 10 and 13; it is readily understood that the breath segmentation algorithm is applied to a selected portion of the data, [0098]-[0099]; regardless, the processor may be configured to control a comparison of the data of the feature set of detection values (a selected set of detection values of the data) with a set of stored data threshold of the memory, [0009]),
calculating a breathing parameter value based at least partly on one or more parameters defining the function or line (fig. 10; segmentation algorithm automatically demarks each breath instance by analyzing the flow and volume signals (shown as "Flow" and "Volume" conditions of FIG. 10) to identify the points in time at the beginning and end of each inspiration, calculates inspiration times based on thresholds (see fig. 10); [0098]-[0099]), and
determining the one or more of the breathing parameter ratios (figs. 3-9 and 12-19 and Table II on page 5; the feature set of detection values may be two or more of features of a group of features consisting of (a) a respiratory rate based feature, respiratory rate may be determined as the ratio of inspiratory time for the breath to the period of the breath; [0017] and [0064]-[0068])
Mulqueeny does not explicitly disclose determining the one or more of the breathing parameter ratios based on a rolling average of the breathing parameter value.
Younes discloses an analogous ventilator apparatus with control circuitry that determines respiration rate and breathing parameter ratio ([0018]-[0025] and [0034]-[0037]) and
determines the one or more of the breathing parameter ratios (fig. 3;“calculates the ventilator inflation phase duration that would result in a physiologically desirable T.sub.I/T.sub.TOT. Desirable T.sub.I is estimated from patient current average T.sub.TOT value (20)”; [0058]) based on a rolling average of the breathing parameter value (fig. 3; “the desirable T.sub.I/T.sub.TOT ratio, and the patient current average T.sub.TOT value (20) is updated continuously at suitable intervals, desirable T.sub.I is automatically updated at the same intervals, preferably after each elapsed ventilator cycle”, [0058], see [0053]-[0060]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the controller of Mulqueeny with the updating average algorithms of Younes to continuously update the desirable inspiration time and patient current average of total time (total breath period) in order to continuously update/adjust the desirable inspiration output/ventilator inspiration time appropriately in response to spontaneous changes in the patient rate, which are quite frequent (Younes: [0053]-[0067], see [0058] and [0065]).
Regarding claim 7, Mulqueeny further discloses
a respiratory apparatus (Mulqueeny: respiration treatment apparatus 1102; Younes: rolling average algorithm) of Claim 6,
wherein the breathing parameter value is a Boolean or Categorical value or data type (see fig. 10; breath segmentation algorithm demarks expiration and inspiration as well as inspiration time based on thresholds, i.e. inspiration confirmed state is when flow > α and expiration confirmed state is when flow < = α , [0098]-[0099]; it would have been readily understood that the algorithm uses Boolean operators to produce a categorical value; in other words, it compares flow and volume values and evaluates whether it’s true or false to determine the categorical value (which of the four states corresponds to the applied data segment) that is calculated or determined based on one or more parameters defining the fitted function or line (fig. 10; segmentation algorithm automatically demarks each breath instance by analyzing the flow and volume signals (shown as "Flow" and "Volume" conditions of FIG. 10) to identify the points in time at the beginning and end of each inspiration, calculates inspiration times based on flow and volume thresholds (see fig. 10); [0098]-[0099]).
Regarding claim 8, Mulqueeny discloses
a respiratory apparatus (respiration treatment apparatus 1102) of Claim 1,
wherein the controller is configured to process the breathing parameter data (figs. 3-9 and 12-19; controller 1112 with asynchrony detector processes sensor signal data to calculate detection values (see claim 1 above); [0064]) to generate the one or more breathing parameter ratios (figs. 3-9 and 12-19 and Table II on page 5; the feature set of detection values may be two or more of features of a group of features consisting of (a) a respiratory rate based feature, respiratory rate may be determined as the ratio of inspiratory time for the breath to the period of the breath; [0017] and [0065]-[0068]) by:
calculating a breathing parameter value based on the breathing parameter data (figs. 3-9 and 12-19; calculates detection values based on sensor signals on a breath by breath basis; [0063]-[0064]) and
determining the one or more of the breathing parameter ratios (figs. 3-9 and 12-19 and Table II on page 5; the feature set of detection values may be two or more of features of a group of features consisting of (a) a respiratory rate based feature, respiratory rate may be determined as the ratio of inspiratory time for the breath to the period of the breath; [0017] and [0064]-[0068])
Mulqueeny does not explicitly disclose determining the one or more of the breathing parameter ratios based on a rolling average of the breathing parameter value.
Younes discloses an analogous ventilator apparatus with control circuitry that determines respiration rate and breathing parameter ratio ([0018]-[0025] and [0034]-[0037]) and
determines the one or more of the breathing parameter ratios (fig. 3;“calculates the ventilator inflation phase duration that would result in a physiologically desirable T.sub.I/T.sub.TOT. Desirable T.sub.I is estimated from patient current average T.sub.TOT value (20)”; [0058]) based on a rolling average of the breathing parameter value (fig. 3; “the desirable T.sub.I/T.sub.TOT ratio, and the patient current average T.sub.TOT value (20) is updated continuously at suitable intervals, desirable T.sub.I is automatically updated at the same intervals, preferably after each elapsed ventilator cycle”, [0058], see [0053]-[0060]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the controller of Mulqueeny with the updating average algorithms of Younes to continuously update the desirable inspiration time and patient current average of total time (total breath period) in order to continuously update/adjust the desirable inspiration output/ventilator inspiration time appropriately in response to spontaneous changes in the patient rate, which are quite frequent (Younes: [0053]-[0067], see [0058] and [0065]).
Regarding claim 9, Mulqueeny further discloses
the respiratory apparatus (Mulqueeny: respiration treatment apparatus 1102; Younes: rolling average algorithm) of Claim 8,
wherein the breathing parameter value is a Boolean or Categorical value or data type (see fig. 10; breath segmentation algorithm demarks expiration and inspiration as well as inspiration time based on thresholds, i.e. inspiration confirmed state is when flow > α and expiration confirmed state is when flow < = α , [0098]-[0099]; it would have been readily understood that the algorithm uses Boolean operators to produce a categorical value; in other words, it compares flow and volume values and evaluates whether it’s true or false to determine the categorical value (which of the four states corresponds to the applied data segment) that is calculated or determined based on one or more parameters defining the fitted function or line (fig. 10; segmentation algorithm automatically demarks each breath instance by analyzing the flow and volume signals (shown as "Flow" and "Volume" conditions of FIG. 10) to identify the points in time at the beginning and end of each inspiration, calculates inspiration times based on flow and volume thresholds (see fig. 10); [0098]-[0099]).
Claims 19, 20, and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Mulqueeny (US 20120037159) in view of White (US 20160193438).
Regarding claim 19, Mulqueeny discloses
the respiratory apparatus (respiration treatment apparatus 1102) of Claim 1,
wherein the controller is configured to display on the respiratory apparatus (see figs. 12 (shows an example of controller 1112 of respiration apparatus 1102) and 13; detection device 1206 includes a display interface 1210 to output data from the detection methodologies as previously discussed (e.g., asynchrony events and information, etc.; [0298]) based on analysing the one or more breathing parameter ratios and/or breathing parameters (figs. 3-10 and 12-19; display total respiration, inspiration, and expiration times and ratios; [0063]-[0080] and [0098]-[0099]).
Mulqueeny does not disclose wherein the controller is configured to trigger alarms and/or notifications for display on the respiratory apparatus.
White discloses an analogous flow therapy apparatus
wherein the controller (fig. 1; controller 13 controls components of apparatus such as user interface 14 for output/displaying information; [0493]) is configured to trigger alarms and/or notifications for display on the respiratory apparatus (fig. 1; triggers alarm based on information of trends in the patient’s inspiratory or expiratory flow rates displayed (tabular form, graphically or by some other means) on interface 14 of flow therapy apparatus 1; [0792]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the display interface and controller of Mulqueeny with the alarm of the user interface of White to automatically change the delivered flow rate and/or oxygen, provide a treatment recommendation to the user or a recommendation that the user change the patient treatment to a higher or lower level respiratory support based on inspiratory/expiratory information such as when the device detects that the patients inspiratory or expiratory flow rate exceeds a certain pre-defined limit (White: [0493] and [0792]-[0794]).
Regarding claim 20, Mulqueeny discloses
the respiratory apparatus (respiration treatment apparatus 1102) of Claim 1,
Mulqueeny does not explicitly disclose wherein the controller is configured to apply trend analysis to one or more breathing parameter ratios and/or breathing parameters, and triggers alarms and/or notifications for display based on the trend analysis and configurable trend thresholds.
White discloses an analogous flow therapy apparatus
wherein the controller (fig. 1; controller 13 controls components of apparatus such as user interface 14 for output/displaying information; [0493]) is configured to apply trend analysis to one or more breathing parameter ratios and/or breathing parameters (fig. 1; display of the trend in a patient's inspiratory or expiratory flow rate (for example in tabular form, graphically or by some other means on the input/output interface 14) could help to provide information; [0792]-[0794]), and triggers alarms and/or notifications for display based on the trend analysis and configurable trend thresholds. (fig. 1; triggers alarm based on information of trends in the patient’s inspiratory or expiratory flow rates to be displayed (tabular form, graphically or by some other means) on interface 14 of flow therapy apparatus 1; [0792]-[0794]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the display interface and controller of Mulqueeny with the alarm of the user interface of White to automatically change the delivered flow rate and/or oxygen, provide a treatment recommendation to the user or a recommendation that the user change the patient treatment to a higher or lower level respiratory support based on inspiratory/expiratory information such as when the device detects that the patients inspiratory or expiratory flow rate exceeds a certain pre-defined limit (White: [0493] and [0792]-[0794]).
Regarding claim 22, Mulqueeny discloses
the respiratory apparatus (respiration treatment apparatus 1102) of Claim 1,
wherein the respiratory apparatus is configured or operable to deliver high flow therapy to a patient (fig. 11; the respiratory treatment apparatus 1102 will also carry a flow of air or breathable gas to and/or from a patient; [0290]) via an interface (fig. 11; via a mask 1108; [0290]).
Mulqueeny does not explicitly disclose the respiration apparatus configured to deliver therapy to a patient via an unsealed interface.
White discloses an analogous respiration apparatus (fig. 1; flow therapy apparatus [0007] and [0493])
configured to deliver therapy to a patient via an unsealed interface (fig. 1; flow therapy apparatus that delivers gas flow to a patient with a non-sealing patient interface; [0007] and [0855]-[0856]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the mask of Mulqueeny with the non-sealing patient interface as disclosed in White to yield the predictable result of providing high flow therapy to a patient in a non-sealed system where are flows are freely available to exhaust to the atmosphere (White: [0007] and [0855]-[0856]).
Claims 23 and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Mulqueeny (US 20120037159) in view of Peake (US 20200360636).
Regarding claim 23, Mulqueeny discloses
the respiratory apparatus (respiration treatment apparatus 1102) of Claim 1,
Mulqueeny does not disclose wherein the respiratory apparatus further comprises a humidifier that is configured to heat and/or humidify the flow of gases, and wherein the flow generator and humidifier are integrated within or provided in a main housing.
Peake discloses an analogous flow system using a flow generator, sensor, and computing device
wherein the respiratory apparatus (figs. 1-4c and 5b-5c; apparatus or device of treating a respiratory disorder; [0078]) further comprises a humidifier that is configured to heat and/or humidify the flow of gases (figs. 1-4c and 5b-5c; air from RPT device 4000 (flow generator) is humidified in humidifier 5000; [0056]-[0058] and [0162]-[0167]), and wherein the flow generator and humidifier are integrated within or provided in a main housing (see figs. 1-4c; RPT device 4000 for generating flow and humidifier 5000 are integrated/provided together; [0056]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the respiratory treatment apparatus of Mulqueeny with the humidifier as disclosed in Peake to increase the temperature or humidity of the flow before delivery to the patient’s airways, therefore, providing a therapeutically beneficial amount of water vapor to a flow of air to ameliorate a medical respiratory condition of a patient (Peake: [0056]-[0058] and [0162]-[0167]; [0192]).
Regarding claim 24, the modified device of Mulqueeny further discloses
the respiratory apparatus (Mulqueeny: respiratory treatment apparatus; Peake: humidified integrated with RPT device) of Claim 23,
wherein the flow rate data is received from one or more flow rate sensors (Mulqueeny: figs. 11-12; the apparatus 1102 also may include sensors 1110, such as a pressure sensor and/or flow sensor; [0291]) in the main housings (Peake: figs. 1-4c; RPT device includes transducers 4270 which include flow rate sensors 4274 and RPT device may comprise one or more of the components in an integral unit and humidifier 5000 includes air flow rate transducers 5214; [0085] and [0088]; [0164]), and wherein the flow rate data is received from one or more flow rate sensors that are configured to sense the flow rate of the flow of gases in a flow path of the main housing (Mulqueeny: figs. 11-12; the data may be based on flow f(t) and/or pressure p(t) signals taken from a flow sensor and/or pressure sensor of such an apparatus; [0047]; Peake: Peake: figs. 1-4c; RPT device includes transducers 4270 which include flow rate sensors 4274 which are integrated into the RPT device to adjust the operation of the RPT device and humidifier 5000 includes air flow rate transducer 5214 which sense flow rate if the flow of air in the humidifier; [0085], [0088], [0114], [0133]; [0164]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Lain (US 20120145152) – A mechanical ventilator with a processor and sensors that can calculate one or more patient parameters such as an inhalation to exhalation ratio and respiration rate
Melker (US 6000396) – a microprocessor controller ventilator unit that can calculate inspiratory time and Inspiratory-Expiratory ratio as well as display a warning
Banner (US 20140276173) – a ventilator with a processor that can calculate respiratory parameters from respiratory data such as breathing frequency, inspiratory time, expiratory time, inhalation-to-exhalation time ratio (I:E), etc.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SYDNEY REYES RUSSELL whose telephone number is (703)756-4567. The examiner can normally be reached M-F 930am -6pm.
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/S.R.R./Examiner, Art Unit 3785
/BRANDY S LEE/Supervisory Patent Examiner, Art Unit 3785
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