CTNF 18/434,965 CTNF 87752 Notice of Pre-AIA or AIA Status 07-03-aia AIA 15-10-aia The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA. Priority Acknowledgment is made of applicant’s claim for priority under 35 U.S.C. § 119(e) with reference to Application Number: 63/444353 filed on 02/09/2023. Information Disclosure Statement The Information Disclosure Statement(s) have been reviewed by the examiner and are found to comply with the provisions of 37 CFR 1.97, 1.98, and MPEP § 609. Drawings The drawing(s) have been reviewed by the examiner and are found to comply with the provisions of 37 CFR 1.81 to 1.85. Claim Rejections - 35 USC § 112 07-30-02 AIA 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. 07-34-01 Claims 11 and 13 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. With regard to claim 11, the phrase “an updated iPEEP value applied by the mechanical ventilator” is unclear, as iPEEP refers to an intrinsic PEEP within the patient herself, rather than the PEEP applied by the ventilator. It is unclear how an updated intrinsic PEEP may be applied by a ventilator. Claim 13 recites the limitation "the determined adjustment" in line 1. There is insufficient antecedent basis for this limitation in the claim. It appears the claim should properly depend on claim 12 rather than claim 11 for appropriate antecedent basis. Examiner to interpret the claim as dependent upon claim 12 for the purposes of examination. Claim Rejections - 35 USC § 101 07-04-01 AIA 07-04 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 1-6, 8 -9, 11 and 14 – 15 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. With respect to step 1, claims 1-15 are all within at least one of the four categories of invention. More specifically, claims 1-14 are directed to a machine and claim 15 is directed to a process. In accordance with MPEP 2106.04, each of claims 1-15 has been analyzed to determine whether it is directed to any judicial exceptions. Step 2A, Prong 1 per MPEP 2106.04(a) Each of claims 1-15 recites at least one step or instruction for calculating an iPEEP, which is grouped as a mathematical concept in MPEP 2106.04(a)(2)(I). The claimed limitations involve mathematical relationships, mathematical formulas or equations, mathematical calculations as in MPEP 2106.04(a)(2)(I). Accordingly, each of claims 1-15 recites an abstract idea. Specifically, independent claim 1 recites: “calculating an intrinsic positive end-expiratory pressure (iPEEP) value for the patient based on the ultrasound imaging data and the respiratory data”. Further, claims 2-6, 8 -9, 11 and 14 – 15 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 claimed functions/steps are performed. Accordingly, as indicated above, each of the above-identified claims recites an abstract idea as in MPEP 2106.04(a). Step 2A, Prong 2 per MPEP 2106.04(d) The above-identified abstract idea in each of independent claims 1 and 15 (and their respective dependent claims 2-6, 8 -9, 11 and 14) is not integrated into a practical application under MPEP 2106.04(d) because the additional elements, either alone or in combination, generally link the use of the above-identified abstract idea to a particular technological environment or field of use according to MPEP 2106.05(h). Per claim 1: “A respiration monitoring device, comprising at least one electronic processor programmed to perform a respiration monitoring method” amounts to general computer processing “receiving ultrasound imaging data of a diaphragm of a patient as a function of time during inspiration and expiration” amounts to mere data gathering “while the patient undergoes mechanical ventilation therapy with a mechanical ventilator” amounts to generally linking the use of the above-identified abstract idea to a particular technological environment or field of use, “receiving respiratory data of the patient as a function of time during the inspiration and expiration while the patient undergoes the mechanical ventilation therapy” amounts to mere data gathering, and “displaying, on a display device, a representation of the calculated iPEEP value” amounts to a generically recited element which does not improve the functioning of a computer. Nor do these above-identified additional elements serve to apply the above-identified abstract idea with, or by use of, a particular machine according to MPEP 2106.05(b), effect a transformation according to MPEP 2106.05(c), provide a particular treatment or prophylaxis according to MPEP 2106.04(d)(2) 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 according to MPEP 2106.04(d)(2) and 2106.05(e). 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 display in accordance with MPEP 2106.05(f). For at least these reasons, the abstract idea identified above in independent claims 1 and 15 (and their respective dependent claims) is not integrated into a practical application in accordance with MPEP 2106.04(d). Moreover, the above-identified abstract idea is not integrated into a practical application in accordance with MPEP 2106.04(d) because the claimed method and system merely implements the above-identified abstract idea (e.g., mathematical concept) using rules (e.g., computer instructions) executed by a computer (e.g., the processing unit as recited in claims 1 and 15). 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 according to MPEP 2106.05(f). 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 according to MPEP 2106.05(a). 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) is not integrated into a practical application under MPEP 2106.04(d)(I). Accordingly, independent claims 1 and 15 (and the identified respective dependent claims) are each directed to an abstract idea according to MPEP 2106.04(d). Step 2B per MPEP 2106.05 None of claims 1-6, 8 -9, 11 and 14 – 15 include additional elements that are sufficient to amount to significantly more than the abstract idea in accordance with MPEP 2106.05 for at least the following reasons. The above-identified additional elements are generically claimed 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, MPEP 2106.05(d)(II) along with 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. Further, the above-identified additional element of ventilator and ultrasound data does no more than generally link the use of the above-identified abstract idea(s) to a particular technological environment or field of use as described in MPEP 2106.05(h). In light of Applicant’s specification, the claimed terms ventilator, ultrasound, processing unit, and display are reasonably construed as generic devices. 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 and machines for data gathering, with their already available basic functions, to use as tools in executing the claimed process. See MPEP 2106.05(f). Furthermore, Applicant’s specification does not describe any special programming or algorithms required for the ventilator, ultrasound, processing unit, and display, as it relates to the calculated iPEEP. 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 and ventilation 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 MPEP 2106.05(d)(I)(2) and 2106.07(a)(III)). Adding hardware that performs “‘well understood, routine, conventional activities’ previously known to the industry” will not make claims patent-eligible ( TLI Communications along with MPEP 2106.05(d)(I)). The recitation of the above-identified additional limitations in claims 1-6, 8 -9, 11 and 14 – 15 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 MPEP 2106.05(f) along with 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. See MPEP 2106.05(a) along with 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, per MPEP 2106.05(a), 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 devices and process of 1-6, 8 -9, 11 and 14 – 15 are directed to applying an abstract idea as identified above on a general purpose computer without (i) improving the performance of the computer itself or providing a technical solution to a problem in a technical field according to MPEP 2106.05(a), or (ii) providing 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 according to MPEP 2106.04(d)(2) and 2106.05(e). 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 dependent claims) do not add significantly more because they are simply an attempt to limit the abstract idea to a particular technological environment according to MPEP 2106.05(h). 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 according to MPEP 2106.05(h). When viewed as whole, the above-identified additional elements 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 according to MPEP 2106.04(d)(2) and 2106.05(e). Moreover, 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 according to MPEP 2106.05(g). As such, there is no inventive concept sufficient to transform the claimed subject matter into a patent-eligible application as required by MPEP 2106.05. Therefore, for at least the above reasons, none of the Claims 1-6, 8 -9, 11 and 14 – 15 amounts to significantly more than the abstract idea itself. Accordingly, 1-6, 8 -9, 11 and 14 – 15 are not patent eligible and rejected under 35 U.S.C. 101. Claim Rejections - 35 USC § 103 07-06 AIA 15-10-15 In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status. 07-20-aia AIA 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. 07-21-aia AIA Claim (s) 1, 6, and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over “A New Ultrasound Method for Estimating Dynamic Intrinsic Positive Airway Pressure: A Prospective Clinical Trial” (hereinafter “Bernardi”) further in view of Blanch (US 20050284476) . 1 . Bernardi discloses a respiration monitoring device used to perform a respiration monitoring method including: receiving ultrasound imaging data of a diaphragm of a patient as a function of time during inspiration and expiration (p. 394, left column, hypercapnic patients underwent ultrasonography visualizing the diaphragm; the patients are on mechanical ventilation connected to a mouthpiece, with the ultrasound sensing hyperechoic divergence of lines during inspiration and a granular pattern at the diaphragm-liver interface ending expiration) while the patient undergoes mechanical ventilation therapy with a mechanical ventilator (see p. 392, right column, the patient is on spontaneous or assisted mechanical ventilation, with treatment inclusive of external PEEP; see also Table 1); receiving respiratory data of the patient as a function of time during the inspiration and expiration while the patient undergoes the mechanical ventilation therapy (see p. 394, left paragraph, airflow is recorded while the mechanically ventilated patient is connected to a mouthpiece, thus creating the flow traces of inspiration and expiration; note also table 1, patients on PS are managed via the inspiration/expiration data); calculating an intrinsic positive end-expiratory pressure (iPEEP) value for the patient based on the ultrasound imaging data and the respiratory data (see 394, right column). However, Bernardi does not disclose at least one electronic processor programmed to perform a respiration monitoring method, and displaying, on a display device, a representation of the calculated iPEEP value. Nonetheless, Blanch discloses a respiration monitoring device, comprising at least one electronic processor programmed to perform a respiration monitoring method (see [0037]) and displaying, on a display device, a representation or indication of the iPEEP value (see Fig. 1, display 26, as well as claim 17). Therefore, it would have been obvious to a person having ordinary skill in the art at the time the invention provide the iPEEP value of Bernardi using a processor and display as taught in Blanch for the benefit of automating the calculation and providing it to medical personnel in charge of the patient, as well as additional benefits such as ventilator control. 6 . Bernardi discloses the device of claim 1, wherein the received respiratory data of the patient as a function of time includes a ventilator flow waveform generated during the mechanical ventilation therapy (see p. 394, left paragraph, airflow is recorded while the mechanically ventilated patient is connected to a mouthpiece, thus creating the flow traces of inspiration and expiration), and calculating the iPEEP value comprises: detecting an onset of inspiratory effort by the patient based on the ultrasound imaging data (see p. 394, right column). However, Bernardi does not disclose determining an air flow value from the lungs of the patient at the detected onset of inspiratory effort by the patient from the ventilator flow waveform; and calculating the iPEEP value based on the determined air flow value from the lungs of the patient at the detected onset of inspiratory effort by the patient. Nonetheless, Blanch discloses determining an air flow value from the lungs of the patient at the detected onset of inspiratory effort by the patient from the ventilator flow waveform (see [0007, 0069-0071], where esophageal balloon measurement is the gold standard of inspiration onset as discussed in Bernardi); and calculating the iPEEP value based on the determined air flow value from the lungs of the patient at the detected onset of inspiratory effort by the patient (see equation in paragraph [0070]). Therefore, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to modify the iPEEP calculation in Bernardi according to that in Blanch as such calculation is understood to provide the predictable result of an iPEEP measurement because if gas is still flowing out of the lungs at the onset of inhalation, it can be reasoned that the only force driving this gas flow, at this instant in time, is iPEEP. 15 . Bernardi as modified by Blanch discloses a respiration monitoring method comprising, with an electronic controller: receiving ultrasound imaging data of a diaphragm of a patient as a function of time during inspiration and expiration while the patient undergoes mechanical ventilation therapy with a mechanical ventilator; receiving respiratory data of the patient as a function of time during the inspiration and expiration while the patient undergoes the mechanical ventilation therapy; calculating a positive end-expiratory pressure (PEEP) value for the patient based on the ultrasound imaging data and the respiratory data; and displaying, on a display device, a representation of the calculated PEEP value (see claim 1 above; it is furthermore noted that, as found paragraph [0002] of the instant specification, intrinsic positive end-expiration pressure may be denoted as merely “PEEP” rather than “iPEEP”; examiner furthermore considers “a positive end expiratory pressure (PEEP) for the patient” as a genus that broadly encompasses “iPEEP”) . 07-21-aia AIA Claim (s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bernardi in view of Blanch in view of Angelico (US 20140034054) . 7 . Bernardi discloses the device of claim 6, but does not disclose wherein the method further includes: triggering the mechanical ventilator to initiate a breath based on the determined onset of inspiratory effort by the patient. Angelico discloses triggering the mechanical ventilator to initiate a breath based on the determined onset of inspiratory effort by the patient (see [0084 – 0087, where examiner notes that the Edi signal would correspond to the ultrasound signal in Bernardi). Therefore, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to modify the method of Bernardi in view of Blanch according to inspiratory onset triggering as taught in Angelico for the benefit of near instantaneous coupling between the ventilator and the patient’s diaphragm . 07-21-aia AIA Claim (s) 2 - 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bernardi in view of Blanch in view of “Diaphragm ultrasound as indicator of respiratory effort in critically ill patients undergoing assisted mechanical ventilation: a pilot clinical study” (hereinafter “Umbrello”) . 2 . Bernardi discloses the device of claim 1, wherein the method further includes: determining a diaphragm activity as a function of time based on the received ultrasound imaging data of the diaphragm of the patient, including a divergence in hyperechoic lines; wherein the iPEEP value is calculated based on the diaphragm activity as a function of time and the respiratory data (see p. 394). However, Bernardi does not disclose determining a diaphragm thickness metric as a function of time based on the received ultrasound imaging data of the diaphragm of the patient; wherein the iPEEP value is calculated based on the diaphragm thickness metric as a function of time and the respiratory data. Nonetheless, Umbrello discloses determining a diaphragm thickness metric as a function of time based on the received ultrasound imaging data of the diaphragm of the patient (see p. 1, “conclusions”; p. 2, para 2; p. 3, end of column 1; “key messages”, p. 9). Therefore, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to modify the ultrasound imaging data of Bernardi based off the diaphragm thickness data as taught in Umbrello since thickening during active breathing reflects the magnitude of diaphragmatic effort. Upon providing the modification, the iPEEP value taught in Bernardi is calculated based on the diaphragm thickness metric as a function of time and the respiratory data, as taught in Umbrello. 3 . Bernardi as modified by Umbrello discloses the device of claim 2, wherein the calculating of the iPEEP value includes: identifying a time corresponding to start of inhalation based on the determined diaphragm thickness metric (see Umbrello, p. 3, end of column 1); and calculating the iPEEP value at the identified time corresponding to start of inhalation (see Bernardi, p. 394, right column). 4 . Bernardi discloses the device of claim 2, wherein the calculating of the iPEEP value includes: identifying a time corresponding to start of inhalation based on the received respiratory data; and calculating the iPEEP value at the identified time corresponding to start of inhalation (see Bernard, p. 394, right column, where the latency time is measured according to the onset of inspiratory flow). 5 . Bernardi discloses the device of claim 3, but does not disclose wherein the iPEEP value is calculated as iPEEP=−R{dot over (V)}(t) where R is a respiratory resistance of lungs of the patient and {dot over (V)}(t) is an airflow at the identified time corresponding to start of inhalation which is part of the received respiratory data of the patient. Nonetheless, Blanch discloses wherein the iPEEP value is calculated as iPEEP=−R{dot over (V)}(t) where R is a respiratory resistance of lungs of the patient and {dot over (V)}(t) is an airflow at the identified time corresponding to start of inhalation which is part of the received respiratory data of the patient (see [0007, 0069-0071], where esophageal balloon measurement is the gold standard of inspiration onset as discussed in Bernardi). Therefore, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to modify the iPEEP calculation in Bernardi according to that in Blanch as such calculation is understood to provide the predictable result of an iPEEP measurement because if gas is still flowing out of the lungs at the onset of inhalation, it can be reasoned that the only force driving this gas flow, at this instant in time, is iPEEP . 07-21-aia AIA Claim (s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bernardi in view of Blanch in view of Umbrello in view of Angelico . 8 . Bernardi discloses the device of claim 1, but does not disclose wherein the method further includes: determining a diaphragmatic excursion value of the diaphragm for successive breaths based on the ultrasound imaging data as a function of time; and displaying, on the display device, an alert in response to an increase or decrease of the diaphragmatic excursion values for the successive breaths over time satisfying an alert criterion. Nonetheless, Umbrello discloses determining a diaphragmatic excursion value of the diaphragm for successive breaths based on the ultrasound imaging data as a function of time, see p. 2, left column, para 1. Therefore, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to modify the method of Bernardi to further include excursion monitoring as taught in Umbrello for the benefit of identifying patients with diaphragm dysfunction. However, Umbrello does not disclose displaying, on the display device, an alert in response to an increase or decrease of the diaphragmatic excursion values for the successive breaths over time satisfying an alert criterion. Nonetheless, Angelico discloses displaying, on the display device, an alert in response to an increase or decrease of the values for the successive breaths over time satisfying an alert criterion, see [0164]. Therefore, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to modify the diaphragmatic monitoring of Bernardi in view of Umbrello with an accompanying alert as taught in Angelico for the benefit of notifying the patient and caregiver personnel of the diaphragm dysfunction . 07-21-aia AIA Claim (s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bernardi in view of Blanch in view of Umbrello in view of “Speckle tracking quantification of lung sliding for the diagnosis of pneumothorax: a multicentric observational study” (hereinafter “Duclos”) in view of Angelico . 9 . Bernardi discloses the device of claim 2, including calculating the iPEEP value from the calculated diaphragm thickness metric. Bernardi does not disclose determining lung sliding of lungs of the patient for successive breaths based on speckle tracking performed on the ultrasound imaging data as a function of time; and displaying, on the display device, an alert in response to an increase or decrease of the lung sliding for the successive breaths over time satisfying an alert criterion. Nonetheless, Duclos discloses determining lung sliding of lungs of the patient for successive breaths based on speckle tracking performed on the ultrasound imaging data as a function of time, see “Discussion”, p. 1214, para 1. Therefore, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to modify the method of Bernardi to further include lung sliding tracking as taught in Duclos for the benefit of identifying conditions such as pneumothorax. However, Duclos does not disclose and displaying, on the display device, an alert in response to an increase or decrease of the lung sliding for the successive breaths over time satisfying an alert criterion. Nonetheless, Angelico discloses displaying, on the display device, an alert in response to an increase or decrease of the values for the successive breaths over time satisfying an alert criterion, see [0164]. Therefore, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to modify the lung sliding monitoring of Bernardi in view of Duclos with an accompanying alert as taught in Angelico for the benefit of notifying the patient and caregiver personel of the diaphragm dysfunction . 07-21-aia AIA Claim (s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bernardi in view of Blanch in view of Hete (US 20020121278) . 10 . Bernardi discloses the device of claim 1, but does not disclose wherein the method further includes: determining a negative pressure value based on a respiratory effort of the patient; and in response to the calculated iPEEP value being above a threshold, determining a modified configuration of the mechanical ventilator effective to apply a negative pressure to the patient during exhalation by the patient during the mechanical ventilation therapy to assist with exhalation by the patient; and one of (i) displaying, on the display device, the determined modified configuration, or (ii) controlling the mechanical ventilator to implement the determined modified configuration. Nonetheless, Hete discloses determining a negative pressure value based on a respiratory effort of the patient (see [0050, 0052]); and in response to the calculated iPEEP value being above a threshold, determining a modified configuration of the mechanical ventilator effective to apply a negative pressure to the patient during exhalation by the patient during the mechanical ventilation therapy to assist with exhalation by the patient; and one of (i) displaying, on the display device, the determined modified configuration, or (ii) controlling the mechanical ventilator to implement the determined modified configuration (see [0050], 0052], the negative pressure is used to eliminate autoPEEP or stagnant pressure when present). Therefore, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to modify the method of Bernardi to provide negative pressure in response to iPEEP accumulation because the development of stagnation pressure creates hyperinflation exhibited by iPEEP, and reduction of the stagnation would thereby eliminate the issue . 07-21-aia AIA Claim (s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bernardi in view of Blanch in view of “Effect of external PEEP in patients under controlled mechanical ventilation with an auto-PEEP of 5 cmH2O or higher” (hereinafter “Natalini”) . 11 . Bernardi discloses the device of claim 1, but does not disclose wherein the method further includes: determining an updated iPEEP value applied by the mechanical ventilator from the received respiratory data; calculating a total PEEP value as a sum of the calculated iPEEP value and the determined updated iPEEP value. Natalini discloses a method of determining an updated iPEEP value applied by the mechanical ventilator from the received respiratory data; calculating a total PEEP value as a sum of the calculated iPEEP value and the determined updated iPEEP value (see p. 6, column 1, para 3 – p. 6, column 2, para 1, Fig. 2, wherein the PEEPtot is equal to the calculated autoPEEP as well as the application of PEEP; for example, the PEEPtot is 10cm H2O with a calculated autoPEEP of 4 cm H2O and applied PEEP of 6 cm H2O in Fig. 2; examiner notes that the interpretation is appropriate per the 112(b) in the rejection above). Therefore, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to modify the method of Bernardi to measure total PEEP and iPEEP as taught in Natalini for the benefit of understanding the fraction of contributing iPEEP in total PEEP, which may furthermore contribute to understanding of potential flow limitation impacting the patient . 07-21-aia AIA Claim (s) 12 - 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bernardi in view of Blanch in view of Mulqueeny (US 20080110461) . 12 . Bernardi discloses the device of claim 1, but does not disclose wherein the method further includes: determining an adjustment of at least one mechanical ventilation setting of the mechanical ventilator based on the calculated iPEEP value; and one of: (i) applying the determined adjustment to the mechanical ventilator or (ii) displaying, on the display device, the determined adjustment as a proposed adjustment. Bernardi does disclose it is important to set the external PEEP correctly during MV to reduce the inspiratory effort required to trigger the ventilator and to avoid further hyperinflation, see c. 392, right column. Mulqueeny discloses wherein the method further includes: determining an adjustment of at least one mechanical ventilation setting of the mechanical ventilator based on the calculated iPEEP value; and one of: (i) applying the determined adjustment to the mechanical ventilator or (ii) displaying, on the display device, the determined adjustment as a proposed adjustment (see [0018], [0020], ventilator applied external PEEP is set to offset PEEPi dependent upon the PEEPi level). Therefore, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to modify the method and processor of Bernardi in view of Blanch according to the offset external PEEP of Mulqueeny in order to reduce the magnitude of negative deflection in pleural pressure required to trigger the ventilator, and since Bernardi already measures PEEPi on a breath-to-breath basis using the applied ultrasound in both spontaneous and assisted breathing. 13 . Bernardi as modified by Mulqueeny discloses the device of claim 12, wherein the determined adjustment includes one of: a change in an exhalation time; and a change in a pressure applied by the mechanical ventilator during exhalation (see [0018], external PEEP) . 07-21-aia AIA Claim (s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bernardi in view of Blanch in view of Souzy (US 20180256075) . 14 . Bernardi discloses the device of claim 1, but does not disclose further comprising: an ultrasound imaging device including an ultrasound patch attached to a portion of the patient, wherein the at least one electronic processor controls the ultrasound imaging device to receive the ultrasound imaging data of the diaphragm of the patient from the ultrasound patch; and a mechanical ventilator configured to deliver mechanical ventilation therapy to the patient. Nonetheless, Souzy discloses an ultrasound imaging device including an ultrasound patch attached to a portion of the patient, wherein the at least one electronic processor controls the ultrasound imaging device to receive the ultrasound imaging data of the diaphragm of the patient from the ultrasound patch (see [0043 – 0050, Figs. 1 and 2); and a mechanical ventilator configured to deliver mechanical ventilation therapy to the patient, see [0094 – 0100]. Therefore, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to modify the method of Bernardi according to the ultrasound patch communicating with ventilator of Souzy for the benefit of stably supporting the ultrasound along the diaphragm so as to automatically monitor and provide feedback for ventilator synchrony . Conclusion 07-96 AIA The prior art made of record and not relied upon is considered pertinent to applicant's disclosure : please see the provided PTO-892 for additional references . Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRADLEY H PHILIPS whose telephone number is (571)270-5180. The examiner can normally be reached 8:00 - 5:00 M-F. 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, Brandy Lee can be reached at (571) 270-7410. 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. /BRADLEY H PHILIPS/Primary Examiner, Art Unit 3799 Application/Control Number: 18/434,965 Page 2 Art Unit: 3799 Application/Control Number: 18/434,965 Page 3 Art Unit: 3799 Application/Control Number: 18/434,965 Page 4 Art Unit: 3799 Application/Control Number: 18/434,965 Page 5 Art Unit: 3799 Application/Control Number: 18/434,965 Page 6 Art Unit: 3799 Application/Control Number: 18/434,965 Page 7 Art Unit: 3799 Application/Control Number: 18/434,965 Page 8 Art Unit: 3799 Application/Control Number: 18/434,965 Page 9 Art Unit: 3799 Application/Control Number: 18/434,965 Page 10 Art Unit: 3799 Application/Control Number: 18/434,965 Page 11 Art Unit: 3799 Application/Control Number: 18/434,965 Page 12 Art Unit: 3799 Application/Control Number: 18/434,965 Page 13 Art Unit: 3799 Application/Control Number: 18/434,965 Page 14 Art Unit: 3799 Application/Control Number: 18/434,965 Page 15 Art Unit: 3799 Application/Control Number: 18/434,965 Page 16 Art Unit: 3799 Application/Control Number: 18/434,965 Page 17 Art Unit: 3799 Application/Control Number: 18/434,965 Page 18 Art Unit: 3799 Application/Control Number: 18/434,965 Page 19 Art Unit: 3799 Application/Control Number: 18/434,965 Page 20 Art Unit: 3799
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