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 .
Election/Restrictions
Claims 73-84 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 09/17/2025.
Claim Objections
Claims 63 and 72 are objected to because of the following informalities:
Claim 63 line 8, insert “:” after “comprises”.
Claim 63 line 11, “the predetermined time” should be “a predetermined time”.
Claim 72, line 1-2, “a first ventilation parameter to a second ventilation parameter” should be “the first ventilation parameter to the second ventilation parameter”.
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 63-72 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.
Step 1
Claims 63-72 are directed to a method and are one of the four statutory categories.
Each of Claims 63-72 has been analyzed to determine whether it is directed to any judicial exceptions.
Step 2A, Prong 1
Each of Claims 63-72 recites at least one step or instruction for evaluating volume responsiveness by analyzing values of a parameter capable of reflecting a heartbeat of a patient, which is grouped as a mental process under the 2019 PEG or a certain method of organizing human activity under the 2019 PEG. The claimed limitations can equivalently be done by a medical professional analyzing and comparing values calculated from measurement values obtained under different operating conditions of a respiratory assistance device. The medical professional may also be controlling the operating conditions of the respiratory assistance device. Accordingly, each of Claims 63-72 recites an abstract idea.
Specifically, Claim 63 recites a method for evaluating volume responsiveness, comprising:
collecting first sequence values of a parameter capable of reflecting a heartbeat of a patient within a predetermined time when a first ventilation parameter is used to control a respiratory assistance device to provide respiratory support for the patient;
calculating a variation of the first sequence values;
evaluating whether the patient is volume responsive based on the variation of the first sequence values, and when the variation of the first sequence values is less than or equal to a first threshold, the method further comprises switching the first ventilation parameter to a second ventilation parameter;
collecting second sequence values of the parameter capable of reflecting the heartbeat of the patient within the predetermined time when the second ventilation parameter is used to control the respiratory assistance device to provide respiratory support for the patient, wherein the second ventilation parameter is capable of increasing a variation of an intrapleural pressure of the patient compared to the first ventilation parameter;
calculating a variation of the second sequence values; and
evaluating whether the patient is volume responsive based on the variation of the second sequence values.
Specifically, Claim 72 recites a method for evaluating volume responsiveness, comprising:
when the volume responsiveness needs to be evaluated, switching a first ventilation parameter currently used for controlling a respiratory assistance device to provide respiratory support for a patient to a second ventilation parameter, wherein the second ventilation parameter is capable of increasing a variation of an intrapleural pressure of the patient compared to the first ventilation parameter;
collecting second sequence values of a parameter capable of reflecting a heartbeat of the patient within a predetermined time when the second ventilation parameter is used to control the respiratory assistance device to provide respiratory support for the patient;
calculating a variation of the second sequence values; and
evaluating whether the patient is volume responsive based on the variation of the second sequence values.
(additional element);
Underlined portions of independent claims 63 and 71 recite observations, judgments or evaluations that may be performed by a medical professional, which is grouped as a mental process under the 2019 PEG), additionally this may involve managing interactions between people, namely, humans following rules, which is grouped as a certain method of organizing human activity under 2019 PEG and/or a judgement or evaluation, which is grouped as a mental process under 2019 PEG;
Bolded portions of independent claims 63 and 71 recite additional elements.
Accordingly, as indicated above, each of the above-identified claims recites an abstract idea.
Further, dependent Claims 64-70 and 72 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 63 and 71 (and their respective dependent Claims 64-70 and 72 is not integrated into a practical application under 2019 PEG because the additional elements (identified above in independent Claims 63 and 71), 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 respiratory assistance device as recited in independent claims 63 and 71 are generically recited computer elements in independent Claims 63 and 71 (and their respective dependent claims) do not amount to significantly more because these elements are generic and well-known in the art. The additional element of a respiratory assistance device to provide support for the patient as recited in independent claims 63 and 71 is well-known in the art, as established by Ahmad (US 20140283834 A1) [0008] Mechanical ventilators comprise medical devices that either perform or supplement breathing for patients. Conventional ventilators use positive pressure to deliver gas to the patient's lungs via a patient circuit between the ventilator and the patient. 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 63 and 71 (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 (e.g., a processor, which has not yet been 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 63 and 71 (and their respective dependent claims) is not integrated into a practical application under the 2019 PEG.
Accordingly, independent Claims 63 and 71 (and their respective dependent claims) are each directed to an abstract idea under 2019 PEG.
Step 2B
None of Claims 63-72 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 respiratory assistance device as recited in independent claim 63 and 71.
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.
Additionally, the additional element of a respiratory assistance device to provide support for the patient as recited in independent claims 63 and 71 is well-known in the art, as established by Ahmad (US 20140283834 A1) [0008] Mechanical ventilators comprise medical devices that either perform or supplement breathing for patients. Conventional ventilators use positive pressure to deliver gas to the patient's lungs via a patient circuit between the ventilator and the patient.
The recitation of the above-identified additional limitations in independent Claims 63 and 71 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 methods of Claims 63-72 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 63-72 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 63 and 71 (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 63-72 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 63-72 amounts to significantly more than the abstract idea itself.
Accordingly, Claims 63-72 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)(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) 71 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Myatra et al. (The Changes in Pulse Pressure Variation or Stroke Volume Variation After a “Tidal Volume Challenge” Reliably Predict Fluid Responsiveness During Low Tidal Volume Ventilation).
Regarding claim 71, Myatra discloses a method for evaluating volume responsiveness (title), comprising:
when the volume responsiveness needs to be evaluated (pg. 415, see Objectives), switching a first ventilation parameter (Vt 6mL/kg PBW) currently used for controlling a respiratory assistance device to provide respiratory support for a patient (patients received ventilation using volume-assist control ventilation; pg. 416, see Patients) to a second ventilation parameter (Patients were ventilated using Vt 6mL/kg PBW (12), and transpulmonary thermodilution variables, PPV (PPV6 ), and SVV (SVV6 ) were recorded. EEOT was performed (EEOT6 ) (17). The “tidal volume challenge” was performed by increasing Vt to 8mL/kg PBW, and pulse contour cardiac index, PPV (PPV8 ), and SVV (SVV8 ) were recorded after 1 minute.; pg. 416, see Methods), wherein the second ventilation parameter is capable of increasing a variation of an intrapleural pressure of the patient compared to the first ventilation parameter (The “tidal volume challenge” was performed by increasing Vt to 8mL/kg PBW, and pulse contour cardiac index, PPV (PPV8 ), and SVV (SVV8 ) were recorded after 1 minute.; pg. 416, see Methods. Applicant’s specifications pg. 18 teaches “the change of the intrapleural pressure of the patient may be increased by means of increasing the tidal volume Vt”);
collecting second sequence values of a parameter capable of reflecting a heartbeat of the patient within a predetermined time when the second ventilation parameter is used to control the respiratory assistance device to provide respiratory support for the patient (The “tidal volume challenge” was performed by increasing Vt to 8mL/kg PBW, and pulse contour cardiac index, PPV (PPV8 ), and SVV (SVV8 ) were recorded after 1 minute; pg. 416, see Methods; also see Table 2 and 3);
calculating a variation of the second sequence values (the absolute change and percentage change in PPV and SVV (ΔPPV6–8 and ΔSVV6–8) and (%ΔPPV6–8 and %ΔSVV6–8); pg. 417, see Prediction of Fluid Responsiveness and pg. 418, see Discussion; Table 3); and
evaluating whether the patient is volume responsive based on the variation of the second sequence values (pg. 417, see Prediction of Fluid Responsiveness and Table 2 and 3. The main finding of our study is that when Vt is increased from 6 to 8mL/kg PBW (tidal volume challenge), the absolute change in PPV and SVV (ΔPPV6–8 and ΔSVV6–8) reliably predicts fluid responsiveness with cutoff values of 3.5% and 2.5%, respectively, whereas PVV and SVV at Vt 6mL/kg PBW do not. Although the percentage change in PPV and SVV (%ΔPPV6–8 and %ΔSVV6–8) is reliable in predicting fluid responsiveness, it requires additional calculations and is not practical for use at the bedside. The PPV8 and SVV8 also reliably discriminate responders from nonresponders; however, their sensitivity (75% for both) and negative predictive value (78% and 76%, respectively) are lower than those of ΔPPV6–8 and ΔSVV6–8 (Table 3) and will thus fail to identify one in four responders; pg. 418-419, see Discussion. also see pg. 415, Results).
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) 72 is/are rejected under 35 U.S.C. 103 as being unpatentable over Myatra et al. (The Changes in Pulse Pressure Variation or Stroke Volume Variation After a “Tidal Volume Challenge” Reliably Predict Fluid Responsiveness During Low Tidal Volume Ventilation), as applied to claim 71 above, and further in view of Pfeiffer et al. (US 20210228095 A1).
Regarding claim 72, Myatra discloses the method of claim 71, wherein before switching a first ventilation parameter to a second ventilation parameter, the method further comprises:
detecting a compliance of the patient (The heart rate (HR), systolic blood pressure, diastolic blood pressure, mean arterial pressure, cardiac index, PPV, SVV, central venous pressure (CVP), ratio of the HR and respiratory rate (HR/RR), plateau pressure (Pplat), driving pressure (Pplat – positive end-expiratory pressure [PEEP]), and compliance of the respiratory system (Crs) were recorded at baseline and at specific intervals (Fig. 1); pg. 416, see Methods);
but is silent as to obtaining a correction coefficient when the detected compliance is less than a fifth threshold; and correcting the variation of the second sequence values by the correction coefficient.
However, Myatra teaches PPV is less reliable in predicting fluid responsiveness when Crs is less than 30 mL/cm H2 O than when Crs is greater than or equal to 30 mL/cm H2 O (18); pg. 420 first paragraph.
However, Pfeiffer teaches a method for determining at least one fluid responsiveness parameter including pulse pressure variation (abstract and [0021]) comprising:
detecting a compliance of the patient ([0176-0178] the compliance, Crs, of the respiratory system. The static compliance of whole respiratory system, Crs, comprises lung compliance per se, Cls, and chest wall compliance, Ccw);
obtaining a correction coefficient (degree of adjustment to be applied) and correcting the fluid responsiveness parameter by the correction coefficient ([0035] Preferably, the fluid responsiveness parameter, FRP_norm, is determined by considering a compliance of a respiratory system, Crs, of the individual. [0194] an adaption of f_FRP_MV to the different conditions of the chest wall compliance Ccw is required as made in step S314. Here input data are required that give information if Ccw is normal, increased or decreased and by which degree Ccw is increased or decreased; figure 10 and 13. [0242] an adaption of a FRP normalization function f_FRP_SB, that can be either dependent of RR (f_FRP_SB_RR) or dependent of TVnorm (f_FRP_SB_TV), to the different conditions of static lung compliance Cls further requires input data that gives information if Cls is normal or if and by which degree Cls is increased. This is made in step S440; figure 14 and 19).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Myatra to implement adjusting the fluid responsiveness parameter based on a degree of compliance of the individual, when Crs is less than 30 mL/cm H2O, as it has been established by Myatra that the PPV will be less reliable in this case, in order to obtain pure standardized fluid responsiveness parameters as taught by Pfeiffer [0034].
Allowable Subject Matter
Claim 63-71 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 101, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: the closest prior art of recorded fails to teach among all the limitations or render obvious the combination of features recited in claim 63, as claimed in the instant application. Claim 63 teaches a method for evaluating volume responsiveness, comprising:
collecting first sequence values of a parameter capable of reflecting a heartbeat of a patient within a predetermined time when a first ventilation parameter is used to control a respiratory assistance device to provide respiratory support for the patient;
calculating a variation of the first sequence values;
evaluating whether the patient is volume responsive based on the variation of the first sequence values, and when the variation of the first sequence values is less than or equal to a first threshold, the method further comprises switching the first ventilation parameter to a second ventilation parameter;
collecting second sequence values of the parameter capable of reflecting the heartbeat of the patient within the predetermined time when the second ventilation parameter is used to control the respiratory assistance device to provide respiratory support for the patient, wherein the second ventilation parameter is capable of increasing a variation of an intrapleural pressure of the patient compared to the first ventilation parameter;
calculating a variation of the second sequence values; and
evaluating whether the patient is volume responsive based on the variation of the second sequence values.
The closest prior art of record is Myatra et al. and Su et al. (US 20140073889 A1).
Myatra teaches a method of evaluating volume responsiveness by evaluating the absolute change and percentage change in pulse pressure variation and stroke volume variation after an increase to the tidal volume delivered to the patient. However, Myatra does not support determining the volume responsiveness bases on values before the tidal volume challenge is performed. On the contrary, Myatra explicitly discloses that PPV and SVV values before the increase in tidal volume were not able to reliably predict fluid responsiveness (pg. 418, see Discussion). As such, Myatra does not disclose “evaluating whether the patient is volume responsive based on the variation of the first sequence values, and when the variation of the first sequence values is less than or equal to a first threshold” since the tidal volume experiment is performed without consideration of the first sequence values (PPV6/SVV6) being less than or equal to a threshold. Su teaches a method for determining fluid responsiveness based on SVV, PVI, or PPV values being a certain threshold. However, Su and other prior art such as Aboy et al. (US 20110270097 A1) do not teach performing a secondary test if the fluid responsiveness parameter is below the predetermined threshold wherein before the secondary test comprises changing a ventilation parameter to increase the intrapleural pressure of the patient.
As allowable subject matter has been indicated, applicant's reply must either comply with all formal requirements or specifically traverse each requirement not complied with. See 37 CFR 1.111(b) and MPEP § 707.07(a).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Mautin I Ashimiu whose telephone number is (571)272-0760. The examiner can normally be reached Monday - Friday, 7:30 a.m. - 4:30 p.m. ET.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kendra Carter can be reached at 571-272-9034. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/M.I.A./Examiner, Art Unit 3785
/VALERIE L WOODWARD/Primary Examiner, Art Unit 3785