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 . 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 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.
Information Disclosure Statement
Applicant is reminded of the continuing obligation under 37 CFR 1.56, to timely apprise the Office of any information which is material to patentability of the claims under consideration in this application.
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “device for filling” in claim 1, “ventilation device” in claims 1 and 18, and “fluid draining device” in claims 2 and 17.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof (e.g. for “device for filling,” a pump as in ¶¶s 0018 and 0087, for “ventilation device,” as in Fig. 1, and for “fluid draining device,” also the pump as in ¶ 0018, or more specifically a valve as in ¶ 0087).
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-20 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 pre-AIA the applicant regards as the invention.
Regarding claims 1, 13, 18, and 20, the uses of the phrase “in particular” make the claims unclear. There is question or doubt as to whether the feature introduced by this language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Regarding claim 9, the use of the phrase “i.e.” makes it unclear which language controls.
Regarding claim 19, there is insufficient antecedent basis for the phrase “at least one additional method step implicitly mentioned,” and it is unclear what constitutes an implicit step or an implicit mention.
Claims 2-17, 19, and 20 are rejected because they depend on rejected claims.
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.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claims 1-17 are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101).
Regarding claim 1, the recitation of “a device for filling the balloon probe with a measuring fluid after placing the balloon probe in the esophagus” can be considered as impermissibly including the esophagus/human within the scope of the claim.
Claims 2-17 are rejected because they depend on rejected claims.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1, 4-8, 14-16, 18, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over various teachings of US Patent Application Publication 2017/0304154 (“Azzolini”).
Regarding claim 1, Azzolini teaches [a] calibration system (figure 1, "1 appliance"; paragraph 56: "the calculation means are able to calculate, e.g. according to the methodology described below, the optimal volume of the probe's balloons") for automatically setting an intended operational filling of an esophageal catheter with balloon probe, which can be inserted into the esophagus (paragraph 27: "a first inflatable balloon for detecting the pressure inside the patient's oesophagus"; paragraph 67: "the operator can then proceed with the calibration of the probe, i.e., with the search phase of the optimal volume at least of the first inflatable balloon. This phase can be performed [ ... ] automatically at predefined time intervals"), for determining an esophageal pressure (paragraph 35: "the appliance 1 comprises processing means 8 having at least detection means which can be connected at inlet at least to the first balloon to detect at least the patient's oesophageal pressure p.sub.es"), in particular for a ventilation device (paragraph 38: "can be connected at inlet to a detection device such as, e.g., a fan used for the forced ventilation of the patient"; paragraph 39 "the serial or parallel connection to an external ventilation device"), comprising: - a device for filling the balloon probe with a measuring fluid (paragraph 30: "at least one pneumatic circuit 3 having pumping means 4 associated with the first air inlet/outlet mouth for the inflation/deflation of the first balloon"; paragraph 121: "the pumping means 4 and the air outlet means to perform the operation of deflation/reinflation of the relative balloon, so as to return it to the desired volume of inflation V.sub.g") after placing the balloon probe in the esophagus (paragraph 66 "continuous reading and detection of the oesophageal pressure values p.sub.es"; paragraph 67: "Advantageously, the operator can then proceed with the calibration of the probe"), - a pressure sensor for detecting the esophageal pressure (Peso) prevailing in the balloon probe (paragraph 35: "the appliance 1 comprises processing means 8 having at least detection means which can be connected at inlet at least to the first balloon to detect at least the patient's oesophageal pressure p.sub.es"), and - a calibration controller (paragraph 41: "the appliance 1 comprises calculation means"; paragraph 56: "Preferably, the calculation means are able to calculate, e.g. according to the methodology described below, the optimal volume of the probe's balloons") which is designed such that it incrementally changes the amount of measuring fluid in the balloon probe (paragraphs 69-70: "The calibration procedure is performed as follows: inflation of the balloon to a certain external volume V.sub.g between a minimum volume and a maximum volume"; paragraph 73 "repetition of these phases for each intermediate volume V.sub.g"), the calibration controller recording an esophageal pressure detected by the pressure sensor for each amount of measuring fluid in the balloon probe set incrementally as a measuring point in this way (paragraph 86 and Table 1: "Vg(1) ... Vg(10)"), and assigning the esophageal pressure to the respective set amount of measuring fluid in the balloon probe (paragraph 71: "reading and recording, once the desired volume has been reached and for a specific time period, of the values of oesophageal pressure p.sub.es"; paragraph 73 "repetition of these phases for each intermediate volume V.sub.g"), wherein the calibration controller is designed such that, for approaching the respective measuring points, it monotonically changes the amount of measuring fluid in at least two steps (paragraph 86: "Vg(1):0 ml, Vg(2):0.5 ml ... Vg(10):7ml" – although it is not explicit that the amount of measuring fluid changes monotonically, paragraphs 68, 70, and 73 suggest repeating/increasing inflation, and paragraphs 86, 87, Table 1, etc. suggest monotonic changes in triplets. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use monotonic changes for the purpose of efficiently obtaining the triplets (or the entire series)(i.e., without having to deflate and reinflate the balloon each time), and as a matter of obvious design choice (selecting the order in which to obtain the values from a small number of possibilities)), starting from a start value until an end value is reached (paragraphs 70 and 73: "between a minimum volume and a maximum volume;" “repetition of these phases for each intermediate volume V.sub.g”).
Regarding claim 18, Azzolini teaches [a] method for automated calibration (figure 1, "1 appliance"; paragraph 56: "the calculation means are able to calculate, e.g. according to the methodology described below, the optimal volume of the probe's balloons") of an intended operational filling of an esophageal catheter with balloon probe, which can be inserted into the esophagus (paragraph 27: "a first inflatable balloon for detecting the pressure inside the patient's oesophagus"; paragraph 67: "the operator can then proceed with the calibration of the probe, i.e., with the search phase of the optimal volume at least of the first inflatable balloon. This phase can be performed [ ... ] automatically at predefined time intervals"), for determining an esophageal pressure (paragraph 35: "the appliance 1 comprises processing means 8 having at least detection means which can be connected at inlet at least to the first balloon to detect at least the patient's oesophageal pressure p.sub.es"), in particular for a ventilation device (paragraph 38: "can be connected at inlet to a detection device such as, e.g., a fan used for the forced ventilation of the patient"; paragraph 39 "the serial or parallel connection to an external ventilation device"), comprising the following steps: - filling the balloon probe with a measuring fluid (paragraph 30: "at least one pneumatic circuit 3 having pumping means 4 associated with the first air inlet/outlet mouth for the inflation/deflation of the first balloon"; paragraph 121: "the pumping means 4 and the air outlet means to perform the operation of deflation/reinflation of the relative balloon, so as to return it to the desired volume of inflation V.sub.g") after placing the balloon probe in the esophagus (paragraph 66 "continuous reading and detection of the oesophageal pressure values p.sub.es"; paragraph 67: "Advantageously, the operator can then proceed with the calibration of the probe"), - detecting the esophageal pressure prevailing in the balloon probe (paragraph 35: "the appliance 1 comprises processing means 8 having at least detection means which can be connected at inlet at least to the first balloon to detect at least the patient's oesophageal pressure p.sub.es"), and - incrementally changing an amount of measuring fluid in the balloon probe (paragraphs 69-70: "The calibration procedure is performed as follows: inflation of the balloon to a certain external volume V.sub.g between a minimum volume and a maximum volume"; paragraph 73 "repetition of these phases for each intermediate volume V.sub.g"), wherein for each amount of measuring fluid in the balloon probe set incrementally as a measuring point in this way (paragraph 86 and Table 1: "Vg(1) ... Vg(10)"), the esophageal pressure is detected and assigned to the respective set amount of measuring fluid in the balloon probe (paragraph 71: "reading and recording, once the desired volume has been reached and for a specific time period, of the values of oesophageal pressure p.sub.es"; paragraph 73 "repetition of these phases for each intermediate volume V.sub.g"), wherein, for approaching the respective measuring points, the amount of measuring fluid is changed monotonically in at least two steps (paragraph 86: "Vg(1):0 ml, Vg(2):0.5 ml ... Vg(10):7ml" – although it is not explicit that the amount of measuring fluid changes monotonically, paragraphs 68, 70, and 73 suggest repeating/increasing inflation, and paragraphs 86, 87, Table 1, etc. suggest monotonic changes in triplets. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use monotonic changes for the purpose of efficiently obtaining the triplets (or the entire series)(i.e., without having to deflate and reinflate the balloon each time), and as a matter of obvious design choice (selecting the order in which to obtain the values from a small number of possibilities)), starting from a start value until an end value is reached (paragraphs 70 and 73: "between a minimum volume and a maximum volume;" “repetition of these phases for each intermediate volume V.sub.g”).
Regarding claim 4, various teachings of Azzolini teach all the features with respect to claim 1, as outlined above. Azzolini further teaches wherein the calibration controller is designed to execute at least two measurement cycles in succession (paragraph 82: "if the ratio is not satisfied, the analysis of volume Vg (i) is repeated"; paragraph 92: "If there are not at least 4 volumes V g(i) belonging to the Plateau then the above steps are performed a second time using the adjacent volumes X,5 within the triplet with minimum slope. Example triplet with minimum slope 3-4-5: the half volumes 2.5 3.5 4.5 and 5.5 are evaluated").
Regarding claims 5-8, various teachings of Azzolini teach all the features with respect to claims 1 and 4, as outlined above. Azzolini further teaches wherein the measuring range of the at least two successive measuring cycles is different, wherein a preceding measuring cycle determines the measuring range for a subsequent measuring cycle, wherein the calibration controller is designed such that it sets the distance between successive measuring points differently for the preceding measuring cycle and for the subsequent measuring cycle, wherein the calibration controller is configured to adaptively determine the increments between successive measuring points within the measuring range in a measuring cycle, wherein the calibration controller is designed such that the measuring fluid is not completely drained from the balloon probe between a preceding measuring cycle and a subsequent measuring cycle (paragraphs 90-92: "If there are not at least 4 volumes Vg(i) belonging to the Plateau then the above steps are performed a second time using the adjacent volumes X,5 within the triplet with minimum slope. Example triplet with minimum slope 3-4-5: the half volumes 2.5 3.5 4.5 and 5.5 are evaluated").
Regarding claim 14, various teachings of Azzolini teach all the features with respect to claim 1, as outlined above. Azzolini further teaches wherein the calibration controller is configured to monitor for each measuring point between the start value and the end value whether the respective measurement of the esophageal pressure is affected by external circumstances, and to discard the respective measurement if such external circumstances are ascertained (paragraph 81: "calculate the maximum excursion of the pes F min in 20 seconds, which should not exceed 2 cm H2O:"; paragraph 82: "If the ratio is not satisfied, the analysis of volume V.sub.g (i) is repeated; in case of its not being satisfied again, a window appears asking if the patient is truly passive”).
Regarding claim 15, various teachings of Azzolini teach all the features with respect to claim 1, as outlined above. Azzolini further teaches wherein the calibration controller is designed to calculate a quality index based on the data ascertained during the calibration procedure (paragraph 118: "An indication of the quality of the oesophageal pressure signal is graphically displayed based on the R2 of the ratio (Pes-Vol)").
Regarding claim 16, various teachings of Azzolini teach all the features with respect to claim 1, as outlined above. Azzolini further teaches wherein the calibration controller is configured such that the esophageal pressure does not exceed a predetermined maximum pressure (¶ 0070, there is a maximum V.sub.g and a corresponding p.sub.es).
Regarding claim 19, various teachings of Azzolini teach all the features with respect to claim 18, as outlined above. Azzolini further teaches at least one additional method step implicitly mentioned with reference to a formation of a calibration system (figure 1, "1 appliance"; paragraph 56: "the calculation means are able to calculate, e.g. according to the methodology described below, the optimal volume of the probe's balloons").
Claims 2 and 3 are rejected under 35 U.S.C. 103 as being unpatentable over various teachings of Azzolini in view of US Patent Application Publication 2008/0113081 (“Hossainy”).
Regarding claim 2, various teachings of Azzolini teach all the features with respect to claim 1, as outlined above. Azzolini further teaches a fluid draining device configured to drain measuring fluid from the balloon probe (¶ 0064, pumping means 4 and outlet means for inflating and deflating the balloon), but does not appear to explicitly teach wherein the calibration controller controls the draining device for approaching the respective measuring points such that the amount of measuring fluid in the balloon probe decreases monotonically in at least two steps starting from the start value until the end value is reached.
Hossainy teaches monotonically increasing and/or decreasing pressure in a balloon catheter (claim 27).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to monotonically decrease rather than increase the amount of measuring fluid in the balloon probe to reach the measurement points, in Azzolini as in Hossainy, as a simple substitution with predictable results (Hossainy: claim 27, alternatives; Azzolini: still being able to reach the measurement points, obtain triplets, etc.).
Regarding claim 3, Azzolini-Hossainy teach all the features with respect to claim 2, as outlined above. Azzolini-Hossainy further teaches wherein the calibration controller is configured to control the arrangement for filling the balloon probe with a measuring fluid at least in a first measuring cycle for filling the balloon probe with an amount of measuring fluid that is greater than an upper limit of the measuring range between the start value and the end value (Azzolini: ¶ 0086, etc., inflating to e.g. V.sub.g(10) when desiring to also obtain the measurements below it based on the deflation described in Hossainy. Further, it would have been obvious to overinflate the balloon in the attempt to reach the measurement points via deflation, to make it easier to reach the maximum measurement point by not requiring switching from inflation to deflation specifically at that point).
Claims 9-13 are rejected under 35 U.S.C. 103 as being unpatentable over various teachings of Azzolini in view of non-patent publication Mojoli, Francesco, et al. "In vivo calibration of esophageal pressure in the mechanically ventilated patient makes measurements reliable." Critical care 20.1 (2016): 98 (“Mojoli”).
Regarding claims 9-11, various teachings of Azzolini teach all the features with respect to claim 1, as outlined above. Azzolini does not appear to explicitly teach wherein the calibration controller is designed such that for each measuring point, i.e. for each set amount of measuring fluid in the balloon probe, between the start value and the end value, it ascertains a respective measurement value for the esophageal pressure at the end of an inspiration phase and a measurement value for the esophageal pressure at the end of an expiration phase, and then determines the difference between the esophageal pressure at the end of the inspiration phase and the esophageal pressure at the end of the expiration phase, wherein the calibration controller is configured to determine a maximum value for the difference between the esophageal pressure at the end of the inspiration phase and the esophageal pressure at the end of the expiration phase within a range lying between the start value for the amount of measuring fluid in the balloon probe and the end value for the amount of measuring fluid in the balloon probe, wherein the calibration controller is designed such that, for a respective measuring point between the start value and the end value, it ascertains the measurement value for the esophageal pressure at the end of an inspiration phase and the measurement value for the esophageal pressure at the end of an expiration phase during ongoing ventilation (although ¶¶s 0042 and 0043 do describe calculating variation between two different moments corresponding to e.g. the beginning and end of inhalation/exhalation).
Mojoli teaches obtaining end-expiratory and end-inspiratory esophageal pressure, and then taking the difference between the two (page 2, second and third paragraphs of the Methods section, to find V.sub.BEST). The difference is a maximum difference (V.sub.BEST). The method is performed during ongoing ventilation (Methods section).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to obtain, for each measuring point and during ongoing ventilation, esophageal measurements at end-expiratory and end-inspiratory points, and to take the difference between the two, in Azzolini as in Mojoli, for the purpose of being able to find V.sub.BEST (Mojoli: page 2, second and third paragraphs of the Methods section – also see Abstract: Conclusion). It would have been obvious to obtain the maximum difference as the one corresponding to V.sub.BEST (Mojoli: page 2, second and third paragraphs of the Methods section).
Regarding claim 12, Azzolini-Mojoli teach all the features with respect to claim 11, as outlined above. Azzolini-Mojoli further teaches wherein the calibration controller is configured such that it compares the differences between the esophageal pressure at the end of the inspiration phase and the esophageal pressure at the end of the expiration phase, as determined for the respective measuring points, and then, when across a plurality of successive measuring points, the respective difference determined is within a predetermined fluctuation range about the maximum value, determines an optimum amount of measuring fluid in the balloon probe as an amount having a predetermined distance from an upper and/or lower edge of said plurality of successive measuring points (Mojoli: page 2, third paragraph of the Methods section, “[w]ithin the appropriate volume range, we identified the volume providing the maximum difference between Pes.sub.EI and Pes.sub.EE (V.sub.BEST);” Fig. 5, using a standard deviation with V.sub.BEST and obtaining a mean difference).
Regarding claim 13, various teachings of Azzolini teach all the features with respect to claim 1, as outlined above. Azzolini does not appear to explicitly teach wherein the calibration controller is designed such that it ascertains a plurality of measurement values, in particular a plurality of pairs of measurement values, for the esophageal pressure at the end of an inspiration phase and for the esophageal pressure at the end of an expiration phase, for each measuring point between the start value and the end value, wherein the calibration controller determines an average and a statistical dispersion for the measurement value or pairs of measurement values for each measuring point on the basis of the plurality of measurement values or pairs of measurement values or a parameter derived therefrom, in particular the difference between the esophageal pressure at the end of the inspiration phase and the esophageal pressure at the end of the expiration phase, and determines the number of measurements per measuring point such that the average obtained can be regarded as statistically significant (although ¶ 0078 does mention a moving average).
Mojoli teaches obtaining end-expiratory and end-inspiratory esophageal pressure, and then taking the difference between the two (page 2, second and third paragraphs of the Methods section, to find V.sub.BEST). The difference is a maximum difference (V.sub.BEST). Mojoli teaches obtaining the average end-expiratory and end-inspiratory pressure-volume curves (page 4, right column, first full paragraph), as well as mean and dispersion values that can be used to determine statistical significance (Figs. 4 and 5).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to obtain, for each measuring point and during ongoing ventilation, esophageal measurements at end-expiratory and end-inspiratory points, and to take the difference between the two, in Azzolini as in Mojoli, for the purpose of being able to find V.sub.BEST (Mojoli: page 2, second and third paragraphs of the Methods section – also see Abstract: Conclusion). It would have been obvious to obtain the maximum difference as the one corresponding to V.sub.BEST (Mojoli: page 2, second and third paragraphs of the Methods section). It would have been obvious to evaluate the average/mean and dispersion/statistical significance of these measures as well, as in Mojoli, for the purpose of being able to account for and remove the effects of artifacts (Mojoli: Fig. 5).
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over various teachings of Azzolini in view of US Patent Application Publication 2008/0113081 (“Hossainy”) and non-patent publication Mojoli, Francesco, et al. "In vivo calibration of esophageal pressure in the mechanically ventilated patient makes measurements reliable." Critical care 20.1 (2016): 98 (“Mojoli”).
Regarding claim 17, Azzolini-Hossainy teaches all the features with respect to claim 2, as outlined above. Azzolini-Hossainy further teaches wherein the calibration controller, when approaching the respective measuring points, controls the draining device such that the amount of measuring fluid in the balloon probe, starting from the start value, is incrementally reduced further and further (based on the monotonic deflation of the combination), but does not appear to explicitly teach reducing until the end value is reached when a predetermined minimum end-expiratory esophageal pressure is reached or fallen short of.
Mojoli teaches obtaining esophageal pressure measurements during end-expiratory and end-inspiratory periods, as well as using V.sub.MIN as a threshold (page 2, second and third paragraphs of the Methods section, to find V.sub.BEST).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to reduce pressure until a predetermined minimum was reached, as in Mojoli, since this is the point of zero transmural pressure (Mojoli: page 2, third paragraph of the Methods section), and for the purpose of being able to find V.sub.BEST (Mojoli: page 2, second and third paragraphs of the Methods section – also see Abstract: Conclusion).
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over various teachings of Azzolini in view of US Patent Application Publication 2018/0140793 (“Stenqvist”).
Regarding claim 20, various teachings of Azzolini teach all the features with respect to claim 18, as outlined above. Azzolini does not appear to explicitly teach [a] computer program product containing program instructions, upon execution of which on a data processing system, in particular on a microprocessor or a microcontroller for controlling an esophageal catheter with balloon probe, a method according to claim 18 is carried out.
Stenqvist teaches using a computer program, stored on a computer-readable medium, to carry out the method of the invention (¶ 0021).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the method of Azzolini into program instructions contained in a computer program product, as in Stenqvist, for the purpose of being able to carry out the method on a variety of different data processing systems.
Conclusion
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/ANDREY SHOSTAK/Primary Examiner, Art Unit 3791