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 .
Information Disclosure Statement
The information disclosure statement filed 09/07/2023 fails to comply with 37 CFR 1.98(a)(2), which requires a legible copy of each cited foreign patent document; each non-patent literature publication or that portion which caused it to be listed; and all other information or that portion which caused it to be listed. A copy of the following NPL document listed in the IDS filed on 09/07/2023 were not filed:
OPPERSMA, E. et al., "Functional assessment of the diaphragm by speckle tracking ultrasound during inspiratory loading". J. Appl Phys. 123:1063-1070, (2017).
Santana PV, Cardenas. Diaphragmatic ultrasound: a review of its methodological aspects and clinical uses. J Bras Pneumol. 2022 Nov 20.
https://sonophysio.co.uk/wp-content/uploads/2019/05/LUS-Atelectasis.pdf
The information referred to therein has not been considered.
Claim Objections
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 4-14 are objected to under 37 CFR 1.75(c) as being in improper form because a multiple dependent claim cannot depend from any other multiple dependent claim. See MPEP § 608.01(n). Accordingly, the claims 4-14 have not been further treated on the merits.
Claims 2 and 3 are objected to because of the following informalities:
Claim 2, line 4: “the ventilator data” should read “the received ventilator data” for consistency and clarity.
Claim 2, line 5: “the imaging data” should read “the received imaging data” for consistency and clarity.
Claim 3, lines 1-2: “wherein the electronic controller (13) is configured to:” should read “wherein the electronic controller (13) is further configured to:” for clarity.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 2 and 3 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 2 recites the limitation “wherein the electronic controller (13) is further configured to determine a respiratory pressure of the patient” in lines 1-2. It is unclear if the respiratory pressure of the patient being determined is the same respiratory pressure as the respiratory pressure of the patient disclosed in claim 1 (see lines 6-7), or if Applicant is attempting to disclose a new limitation. For the purpose of examination, the above limitation recited in claim 2 will be interpreted as – a second respiratory pressure of the patient – to clarify the limitation is disclosing a new, or alternative, respiratory pressure value being determined. This interpretation is based on [0037] of Applicant’s specification, where the respiratory pressure of the patient determined based on the received imaging data and the received ventilator data may correspond to one of a driving pressure, transpulmonary pressure, or “any other pressure associated with respiratory of the patient.”
Additionally, claim 2 recites “the respiratory pressure of the patient” in line 6. For at least the reasons provided above, the limitation will be interpreted as – a reference to the second respiratory pressure of the patient – as disclosed earlier in claim 2 (see above).
Claim 3 is rejected due to its dependency on a rejected claim.
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 1-3 and 15 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 1-3 and 15 have been analyzed to determine whether it is directed to any judicial exceptions.
Step 2A, Prong 1
Each of claims 1-3 and 15 recites at least one step or instruction for observation, judgement, and evaluation, which is grouped as a mental process under the 2019 PEG or a certain method of organizing human activity under the 2019 PEG. The claims involve acquiring patient data, determining other parameters of patient data based on the acquired patient data, and displaying the determined parameters of patient data. Accordingly, each of claims 1-3 and 15 recite an abstract idea.
Specifically, claim 1 recites,
A mechanical ventilation device comprising an electronic controller;
A mechanical ventilator;
A display device;
receive imaging data and ventilator data associated with lungs of a patient, determine a respiratory pressure of the patient based at least on the received ventilator data, determine a lung volume and a lung flow for at least one region of the lungs based on lung sliding data determined from the received imaging data and the determined respiratory pressure, determine a regional resistance and elastance for the at least one region of the lungs from the lung volume and the lung flow for the at least one region, and display the regional resistance and elastance for the at least one region of the lungs (observation, judgment or evaluation, which is grouped as a mental process under the 2019 PEG).
Specifically, claim 15 recites,
An electronic controller;
A mechanical ventilator;
A display device;
receiving imaging data (22) and ventilator data associated with lungs of a patient, determining a respiratory pressure of the patient based at least on the received ventilator data, determining a lung volume and a lung flow for at least one region of the lungs based on lung sliding data determined from the received imaging data and the determined respiratory pressure, determining a regional resistance and elastance for the at least one region of the lungs from the lung volume and the lung flow for the at least one region, and displaying the regional resistance and elastance for the at least one region of the lungs (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 2 and 3 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 claims 1 and 15 (and their respective dependent claims 2 and 3) are not integrated into a practical application under 2019 PEG because the additional elements (identified above in independent claims 1 and 15), 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: a mechanical ventilation device, an electronic controller, a mechanical ventilator, and a display device as recited in independent claim 1 and its dependent claims; and an electronic controller, a mechanical ventilator, and a display device as recited in independent claim 15, are generically recited computer elements in independent claims 1 and 15 (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 claims 1 and 15 (and their respective dependent claims) are not integrated into 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 (e.g., an electronic controller and a display device 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 claims 1 and 15 (and their respective dependent claims) are not integrated into practical application under the 2019 PEG.
Accordingly, independent claims 1 and 15 (and their respective dependent claims) are each directed to an abstract idea under 2019 PEG.
Step 2B
None of claims 1-3 and 15 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: a mechanical ventilation device, an electronic controller, a mechanical ventilator, and a display device as recited in independent claim 1 and its dependent claims; and an electronic controller, a mechanical ventilator, and a display device as recited in independent claim 15.
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, [0025], “…a mechanical ventilator 2 for providing ventilation therapy to an associated patient P … The mechanical ventilator 2 also includes an electronic controller (e.g., a microprocessor) 13 for controlling operation of the mechanical ventilator 2, a display device 14 for displaying information about the patient P and/or settings of the mechanical ventilator 2 during mechanical ventilation of the patient P …”.
Accordingly, in light of Applicant’s specification, the claimed terms an electronic controller, a mechanical ventilator, and a display device are 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 electronic controller, mechanical ventilator, or display device. 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 activit[ies]’ previously known to the industry” will not make claims patent-eligible (TLI Communications).
The recitation of the above-identified additional limitations in claims 1-3 and 15 amount 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 1-3 and the method of claim 15 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 1-3 and 15 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 15 (and their respective 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 1-3 and 15 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 1-3 and 15 amount to significantly more than the abstract idea itself.
Accordingly, claims 1-3 and 15 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.
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)(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 and 15 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Kaczka et al. (US 20150290418 A1; hereinafter “Kaczka”).
Regarding claim 1, Kaczka discloses a mechanical ventilation device (100; Fig. 1), comprising an electronic controller (102; Fig. 1; “The system 100 includes the computer 102 that has actuating software installed thereon to control the delivery of medication as described herein,” see [0030]) configured to:
receive imaging data and ventilator data associated with lungs of a patient while the patient undergoes mechanical ventilation therapy with an associated mechanical ventilator ([0046], lines 8-19; [0050]; first two sentences of [0059]);
determine a respiratory pressure of the patient based at least on the received ventilator data (first sentence of [0034]; [0037]);
determine a lung volume and a lung flow for at least one region of the lungs based on lung sliding data determined from the received imaging data and the determined respiratory pressure (first and last sentence of [0034]; [0037]; [0042], lines 1-12; [0050], lines 1-10; [0055], lines 1-8);
determine a regional resistance and elastance for the at least one region of the lungs from the lung volume and the lung flow for the at least one region ([0037], lines 5-11; [0042], lines 1-13; [0050], where tissue stiffness is a fundamental measure of tissue elastance; [0054]-[0055]); and
display the regional resistance and elastance for the at least one region of the lungs on a display device ([0019], lines 6-12, and [0063], hence the system is capable of displaying on a display device, such as display module 340 (see [0032]), calculated/determined values of regional resistance and elastance).
Regarding claim 15, Kaczka discloses a mechanical ventilation method (Abstract; [0017]; second sentence of [0024]) comprising, with an electronic controller (102; Fig. 1; “The system 100 includes the computer 102 that has actuating software installed thereon to control the delivery of medication as described herein,” see [0030]):
receiving imaging data and ventilator data associated with lungs of a patient while the patient undergoes mechanical ventilation therapy with an associated mechanical ventilator ([0046], lines 8-19; [0050]; first two sentences of [0059]);
determining a respiratory pressure of the patient based at least on the received ventilator data (first sentence of [0034]; [0037]);
determining a lung volume and a lung flow for at least one region of the lungs based on lung sliding data determined from the received imaging data and the determined respiratory pressure (first and last sentence of [0034]; [0037]; [0042], lines 1-12; [0050], lines 1-10; [0055], lines 1-8);
determining a regional resistance and elastance for the at least one region of the lungs from the lung volume and the lung flow for the at least one region ([0037], lines 5-11; [0042], lines 1-13; [0050], where tissue stiffness is a fundamental measure of tissue elastance; [0054]-[0055]); and
displaying the regional resistance and elastance for the at least one region of the lungs on a display device ([0019], lines 6-12, and [0063], hence the system is capable of displaying on a display device, such as display module 340 (see [0032]), calculated/determined values of regional resistance and elastance).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 2 and 3 are rejected under 35 U.S.C. 103 as being unpatentable over Kaczka (US 20150290418 A1) in view of Boettger et al. (US 20150073765 A1; hereinafter “Boettger”).
Regarding claim 2, Kaczka discloses the invention as set forth in claim 1. While Kaczka does disclose determining an airway opening pressure (instantaneous pressure measured at patient airway opening, see [0060], where the instantaneous pressure is ventilation data as it is obtained the use of an Enhance Ventilator Waveform, EVW, and enhanced ventilator pressure waveforms are measured directly by the ventilator, see [0049]), Kaczka fails to explicitly disclose determining a respiratory pressure of the patient based on the received ventilator data and further based on the received imaging data by:
determining a respiratory muscle pressure from the imaging data; and
determining the respiratory pressure of the patient from the airway opening pressure and the respiratory muscle pressure.
However, Boettger teaches an analogous system for obtaining patient-specific respiratory data via imaging and creating a biomechanical model of the patient’s respiratory system based on the obtained data ([0007]), where a driving force (i.e., driving pressure) of the respiratory system is defined by a patient-specific thoracic (Examiner Note: thoracic portion of trachea can be interpreted as an airway opening before the tracheal bifurcation) and diaphragmatic pressure distribution ([0027]) obtained from imaging data ([0019] and [0026]; Fig. 10).
Therefore, it would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Kaczka to determine a diaphragm pressure from imaging data (Boettger [0019] and [0026]), as taught by Boettger, such that a driving pressure of the patient’s respiratory system can be determined based on the determined airway opening pressure ([0060]) and the determined diaphragm pressure (Boettger [0019] and [0026]), as taught by Boettger ([0027]), to improve the accuracy in calculating and determining a patient’s driving pressure and better understand the motion and deformation of a patient’s lungs during the respiratory cycle (Boettger [0025]).
Regarding claim 3, Kaczka as modified teaches the invention as set forth in claim 2, wherein the electronic controller (102) is configured to:
synchronize the received imaging data and the received ventilator data with respect to time (received airway opening pressure is received ventilation data, and received diaphragm pressure is received imaging data, see claim 2 above; to determine a driving pressure of the respiratory system, as taught in claim 2 above, it is inherent that the airway opening pressure and diaphragm pressure would be measured at the same time, such that the driving pressure represents the driving pressure of the respiratory system at a specific point in time during a respiratory cycle, Boettger [0026]-[0027] further supports this; Hence, Kaczka as modified by Boettger in claim 2 above teaches the received imaging data of diaphragm pressure, and the received ventilator data of airway opening pressure, is synchronized with respect to time).
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Kaczka (US 20150290418 A1) in view of Teschner & Stenqvist (US 20100228143 A1; hereinafter “Teschner”).
Regarding claim 3, Kaczka discloses the invention as set forth in claim 1, but fails to explicitly disclose wherein the electronic controller (102) is configured to:
synchronize the received imaging data and the received ventilator data with respect to time.
However, Teschner teaches an analogous apparatus to determine functional lung characteristic that are indicative of a patient’s breathing activity of lung areas ([0014]) based on imaging data ([0015]) and ventilation data ([0036]), where airway pressure is simultaneously recorded together with Electrical Impedance Tomography (EIT) data ([0064] and last sentence of [0065]). Teschner further teaches determining an impedance distribution at multiple time points during the breathing cycle of a patient to derive a global impedance change curve, where the global impedance change curve is displayed as a function of time and corresponds to a volume curve of the patient’s breathing cycle ([0035]; Fig. 5).
Therefore, it would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Kaczka to synchronize the received respiratory data and the received imaging data, as taught by Teschner above (Teschner [0064], last sentence of [0065], [0035]; Teschner Fig. 5), such that regional compliance and its intratidal variations can be accurately determined (Teschner [0064], lines 2-3) and to derive phases of a patient’s breathing cycle (Teschner [0036]) to provide personalized and improved treatment to the patient.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Raju et al. (US 11166666 B2): Regarding a portable care management device equipped with a ventilator and imaging system capable of measuring and determining various respiratory parameters and characteristics.
Kremeier et al. (US 11696699 B2): Regarding a system with a ventilator and imaging device capable of measuring local tissue resistances of a patient’s lung for storage and use by the ventilator, and data collected by the ventilator is synchronized with data collected by the imaging device.
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/ABIGAYLE DALE/Examiner, Art Unit 3785
/BRANDY S LEE/Supervisory Patent Examiner, Art Unit 3785
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