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
Claim 4 is objected to because of the following informalities:
Claim 4 recites that the imaging data “includes at least a position of the diaphragm”; as this cannot be considered to be “indicating a dimension”, the claim should recite that the data further includes this additional information.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 19 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claim 19 calls for determining a chest wall compliance from “the received imaging data” and then calculating “the pressure value” based on the chest wall compliance and the calculated diaphragmatic muscle pressure. Per claim 1, the only imaging data received is data indicating a dimension of a diaphragm; the disclosure does not provide any indication of using a dimension of a diaphragm to find chest wall compliance, and appears to use other information from imaging data (see paragraphs [0044]-[0046] as filed). Further, per claim 1, “the pressure value” is “at least one of a transpulmonary pressure or a tidal variation in the transpulmonary pressure”; the only disclosed parameter relating to transpulmonary pressure that is described in the specification as being calculated from chest wall compliance and diaphragmatic muscle pressure is a tidal variation in transpulmonary pressure (see equation 6 as filed); there is no disclosure of transpulmonary pressure itself as being possible to calculate using these parameters. As such, the disclosure does not reasonably convey possession of a system configured to determine a chest wall compliance from “the received imaging data” and then calculate “the pressure value” of at least one of transpulmonary pressure and a variation in transpulmonary pressure based on the chest wall compliance and the calculated diaphragmatic muscle pressure at the time the invention was filed.
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 1-4, 10-12, 16-19 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 1, in lines 6-7, recites that the pressure value is calculated “based on at least the imaging data and the dimension of the diaphragm”; per line 3, the imaging data itself is “indicating a dimension of a diaphragm”. It is unclear if the intent is for the imaging data to include additional data in addition to the dimension of the diaphragm, or if the calculation using both the imaging data and the dimension is a redundant recitation because only the dimension is present in the imaging data. Clarification 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 1-4, 10-12, 16-19 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Please see the following Subject Matter Eligibility (“SME”) analysis:
For analysis under SME Step 1, the claims herein are directed to a system, which would be classified under one of the listed statutory classifications (SME Step 1=Yes).
For analysis under revised SME Step 2A, Prong 1, independent claim 1 recites a ventilation device comprising an electronic controller configured to receive imaging data of a ventilated patient, calculate a transpulmonary pressure from the data, and if the calculated pressure does not meet a criterion, output an alert or output a recommendation.
The dependent claims appear to be encompassed by the abstract idea of the independent claims since they merely indicate processing the data (claims 2, 12, 16), obtaining additional data and generating additional information based on the additional data (claim 3, 4 , 10, 11, 19), and outputting the result (claim 18); claim 17 includes an additional element of adjusting a therapy, discussed below.
The underlined portions of the claims are an indication of elements additional to the abstract idea (to be considered below).
The claim elements may be summarized as the idea of obtaining and storing model data to report biometric information; however, the Examiner notes that although this summary of the claims is provided, the analysis regarding subject matter eligibility considers the entirety of the claim elements, both individually and as a whole (or ordered combination). This idea is within the following grouping(s) of subject matter:
Mental processes (e.g., concepts performed in the human mind such as observation, evaluation, judgment, and/or opinion) as based on the observation and evaluation of imaging data to generate a pressure for evaluation – including a judgment or opinion regarding pressure values.
Therefore, the claims are found to be directed to an abstract idea.
For analysis under revised SME Step 2A, Prong 2, the above judicial exception is not integrated into a practical application because the additional elements do not impose a meaningful limit on the judicial exception when evaluated individually and as a combination. The additional elements are that claim 1 recites an electronic controller as apparently performing the activities, where the activities also include receipt of data and output of an alert or recommendation. These additional elements do not reflect an improvement in the functioning of a computer or an improvement to other technology or technical field, effect a particular treatment or prophylaxis for a disease or medical condition (the “recommended adjustment” is not actively implemented a nor is the generation of the “recommended adjustment” recited with any specificity), implement the judicial exception with, or by using in conjunction with, a particular machine or manufacture that is integral to the claim, effect a transformation or reduction of a particular article to a different state or thing (there is no transformation/reduction of a physical article), and/or apply or use the judicial exception in some other meaningful way beyond generically linking use of the judicial exception to a particular technological environment. Claim 17’s recitation of adjusting ventilator settings corresponding to a recommended adjustment also does not meet the criteria of effecting a particular treatment or prophylaxis as the treatment is still not recited with any specificity, particularly its relation to the abstract idea.
The claims appear to merely apply the judicial exception, include instructions to implement an abstract idea on a computer, or merely use a computer as a tool to perform the abstract idea. The additional elements appear to merely add insignificant extra-solution activity to the judicial exception and/or generally link the use of the judicial exception to a particular technological environment or field of use.
For analysis under SME Step 2B, the claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the additional elements, as indicated above, are merely “[a]dding the words ‘apply it’ (or an equivalent) with the judicial exception, or mere instructions to implement an abstract idea on a computer, e.g., a limitation indicating that a particular function such as creating and maintaining electronic records is performed by a computer, as discussed in Alice Corp.” that MPEP § 2106.05(I)(A) indicates to be insignificant activity.
There is no indication the Examiner can find in the record regarding any specialized computer hardware or other “inventive” components, but rather, the claims merely indicate computer components which appear to be generic components and therefore do not satisfy an inventive concept that would constitute “significantly more” with respect to eligibility. Paragraph [0023] as filed indicates “an electronic controller 13 (e.g., an electronic processor or a microprocessor)” – i.e., a generic or general-purpose computer.
Receipt of data is, at best, data gathering, where the data is not even actively sensed but merely acquired from an external source - see MPEP 2106.05(d), where determining the level of a biomarker by any means, Mayo, 566 U.S. at 79, 101 USPQ2d at 1968; Cleveland Clinic Foundation v. True Health Diagnostics, LLC, 859 F.3d 1352, 1362, 123 USPQ2d 1081, 1088 (Fed. Cir. 2017) is held to be well-understood, routine, and conventional.
The output of an alert or a recommendation, as recited, is at best an insignificant post-solution output of a result (see MPEP 2106.05 - Presenting data, OIP Techs., 788 F.3d at 1362-63, 115 USPQ2d at 1092-93 - another type of activity that the courts have found to be well-understood, routine, conventional activity when they are claimed in a merely generic manner (e.g., at a high level of generality) or as insignificant extra-solution activity), where these outputs are not disclosed as being output to or with any particular component nor is there any indication of any response occurring as a result of these outputs.
The individual elements therefore do not appear to offer any significance beyond the application of the abstract idea itself, and there does not appear to be any additional benefit or significance indicated by the ordered combination, i.e., there does not appear to be any synergy or special import to the claim as a whole other than the application of the idea itself.
The dependent claims, as indicated above, appear encompassed by the abstract idea since they merely limit the idea itself or the computer components performing the abstract idea, or recite receiving additional data, where the additional data is not sensed by the claimed invention and as presented this is merely the transfer of information from an unnamed source; therefore the dependent claims do not add significantly more than the idea.
Therefore, SME Step 2B=No, any additional elements, whether taken individually or as an ordered whole in combination, do not amount to significantly more than the abstract idea, including analysis of the dependent claims.
Please see the Subject Matter Eligibility (SME) guidance and instruction materials at https://www.uspto.gov/patent/laws-and-regulations/examination-policy/subject-matter-eligibility, which includes the latest guidance, memoranda, and update(s) for further information.
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) 1-3, 10-12, 16-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Euliano (US 2021/0016035) in view of Peterson (US 2022/0130040).
Regarding claims 1 and 16, Euliano discloses a mechanical ventilation device (paragraph [0018]) comprising at least one electronic controller (paragraph [0078]) configured to:
receive imaging data related to a dimension of a diaphragm of a patient during inspiration and expiration while the patient undergoes mechanical ventilation therapy with an associated mechanical ventilator (paragraph [0105], any imaging data is “related” to a dimension);
calculate a pressure value (P;, DP,) of pressure in a chest of the patient based on at least the imaging data (paragraphs [0104], [0105]), wherein the pressure comprises at least one of a transpulmonary pressure or a tidal variation in the transpulmonary pressure (paragraphs [0004], [0068]-[0069], [0104], [0105]); and
when the calculated pressure value (P;, DP,) does not satisfy an acceptance criterion, perform, during the therapy, at least one of:
output an alert indicative of the calculated pressure value (Pi, DP,) failing to satisfy the acceptance criterion (paragraph [0125], [0135]); and
output a recommended adjustment to one or more parameters of the mechanical ventilation therapy delivered to the patient (paragraph [0135]).
Euliano discloses using the imaging data of a diaphragm to acquire a noninvasive transpulmonary pressure (paragraph [0004], [0105]-[0106]), but does not explicitly recite the data comprising and indicating the dimensions thereof; the Examiner notes that absent any frame of reference any dimensions of a three-dimensional object will inherently include a “thickness” in some direction.
Peterson teaches a mechanical ventilation system comprising a controller configured to receive imaging data indicating a dimension of a diaphragm of a patient during inspiration and expiration (paragraph [0013], [0072]), and to calculate a transpulmonary pressure based on the imaging data and the dimension of the diaphragm (paragraphs [0011], [0092]). It would have been obvious to one of ordinary skill in the art at the time the invention was filed to have made the system of Euliano with the imaging data indicating a dimension of the diaphragm during the ventilation therapy, as taught by Peterson, as Euliano does not specify what parameter in the imaging data should be used for the calculation and Peterson teaches using a dimension of a diaphragm for calculating transpulmonary pressure.
Regarding claim 2, Euliano further discloses that the at least one electronic controller is configured to calculate the pressure value by:
determining a diaphragmatic muscle pressure (Pmus) from the received imaging data; and calculating the pressure value based on at least the calculated diaphragmatic muscle pressure (paragraph [0105]).
Regarding claim 3, Euliano further discloses a wearable ultrasound transducer configured to acquire at least a portion of the imaging data as ultrasound imaging data of at least the diaphragm of the patient (paragraph [0105]).
Regarding claim 10, Euliano further discloses that the at least one electronic controller is further configured to:
receive, from the associated mechanical ventilator, at least one of an airflow during inhalation of the patient and an airflow pressure in an airway of the patient during mechanical ventilation therapy; and calculate the pressure value further based on the airflow and/or the airflow pressure (paragraph [0018]).
Regarding claim 11, Euliano further discloses a mechanical ventilator configured to deliver the mechanical ventilation therapy to the patient; wherein the mechanical ventilator is configured to measure the at least one of an airflow during inhalation of the patient and an airflow pressure in an airway of the patient during the mechanical ventilation therapy (paragraph [0018]).
Regarding claim 12, Euliano further discloses that the mechanical ventilator includes a display device (paragraph [0024]), and the at least one electronic controller is further configured to:
control the display device to display a pressure-volume curve of lungs of the patient during the mechanical ventilation therapy (paragraph [0109]; figure 15); and at least one of:
output the alert when the calculated pressure value is outside of a range of values defined by the displayed pressure-volume curve (paragraph [0076]); and
output a recommended adjustment to one or more parameters of the mechanical ventilation therapy delivered to the patient (figure 10).
Regarding claim 17, Euliano further discloses that the at least one electronic controller is further configured to adjust setting of the mechanical ventilator corresponding to the recommended adjustment to the one or more parameters (paragraph [0109]).
Regarding claim 18, Euliano further discloses that the at least one electronic controller is further configured to output the alert by displaying a message on a display device of the mechanical ventilator (paragraph [0024]).
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Euliano, as modified by Peterson above, and further in view of DiNino (DiNino E, Gartman EJ, Sethi JM, et al Diaphragm ultrasound as a predictor of successful extubation from mechanical ventilation Thorax 2014;69:431-435.).
Regarding claim 4, Euliano further discloses that the ultrasound imaging data includes at least a position of the diaphragm of the patient during inspiration and expiration while the patient undergoes mechanical ventilation therapy to determine the diaphragmatic muscle pressure (Pmus) (paragraph [0105]); Euliano does not disclose further determining a diaphragm thickness change (TFdi) of the diaphragm, and Peterson does not disclose the dimensions involved as including a thickness. DiNino teaches a device configured to receive ultrasound imaging data relating to a dimension of a diaphragm during mechanical ventilation therapy (p. 423, “Abstract: Methods”; p. 424, “Measurements”, “Protocol”), where the imaging data includes at least a position of the diaphragm during inhalation and exhalation for determining a thickness change of the diaphragm (p. 424, “Measurements”, particularly Δtdi%, the per cent change in diaphragm thickness between end-expiration and end-inspiration). It would have been obvious to one of ordinary skill in the art at the time the invention was filed to have made the device of Euliano, as modified, and configured it to further determine a diaphragm thickness change, as taught by DiNino, in order to allow additional assessment of possible diaphragm disfunction (DiNino, “Discussion” p. 425-426)
Response to Arguments
Applicant's arguments filed 21 April 2026 have been fully considered but they are not persuasive.
Regarding the rejections under 101, Applicant initially argues that the invention as claimed does not recite an abstract idea which falls into the category of mental processes because a “human mind” cannot perform the tasks of receiving data and calculating a pressure value based on data from during delivered therapy. This is entirely unpersuasive; the task of “receiving” data is not recited as having any aspects that cannot be replicated by a human observing an image or thinking about a number. Similarly, Applicant asserts that the task of calculating a pressure cannot be performed “efficiently” enough to be done “during the mechanical ventilation therapy”; aside from the claim not limiting the calculation itself to being during therapy, only reciting that the dimension data was obtained during therapy, mechanical ventilation therapy does not have any inherent time limit or speed associated with the therapy; rather, patients are often on ventilators for extended time periods which include months or even years, such that no part of calculating the pressure needs to be done with any sort of rapidity that might preclude it from being performed in the human mind.
Applicant next asserts that the process of calculating the transpulmonary pressure or tidal variation thereof from imaging data provides an improvement based on a general assertion that such a determination “can be difficult”; it should be noted that an improvement must be provided by an additional element, not the abstract idea itself, where in this case the abstract idea itself is the process of calculating the transpulmonary pressure, such that merely performing a calculation using received data cannot be considered an additional element providing any sort of improvement.
Applicant then asserts that these calculations “improve the functionality of ventilatory systems” and thus provide a technological improvement – it is entirely unclear what this improvement to ventilatory systems might be, as the results of these calculations are merely “output” and do not have any recited, claimed, particular effect that might result in “protecting the patient” as asserted by Applicant.
Applicant continues by presenting extensive discussion of the cases upon which step 2B of analysis is established; Applicant does not address any of the actual claim limitations beyond referring to “various elements”, such that this general assertion of being significantly more is entirely unpersuasive.
The claims remain rejected.
Applicant’s arguments with respect to the rejections under Euliano have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Applicant’s remarks address only the newly added limitations, which have been rejected above.
Conclusion
No art has been applied against claim 19; however, as the claim is rejected under 112a, 112b, and 101 above, it is not presently allowable.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: Scaramuzzo G, Spadaro S, Spinelli E, Waldmann AD, Bohm SH, Ottaviani I, Montanaro F, Gamberini L, Marangoni E, Mauri T and Volta CA (2021) Calculation of Transpulmonary Pressure From Regional Ventilation Displayed by Electrical Impedance Tomography in Acute Respiratory Distress Syndrome. Front. Physiol. 12:693736. doi: 10.3389/fphys.2021.693736
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/KAREN E TOTH/Examiner, Art Unit 3791
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