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 .
Amendment
This office action is responsive to the preliminary amendment filed on 8/8/23. As directed by the amendment: claims 1-11 have been amended, no claims have been canceled, and no new claims have been added. Thus, claims 1-11 are presently pending in the application.
Drawings
The drawings are objected to because figures 1-9 have numbers and words that are illegible. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The disclosure is objected to because of the following informalities: Page 8, line 9 recites “Figures 5 to o” suggested to be changed to --Figures 5 to 9-- to correct a typographical error.
Appropriate correction is required.
Claim Objections
Claims 1, 3-5 and 8 are objected to because of the following informalities:
Claim 1 recites “the ventilator” in lines 5 and 10, suggested to be changed to --the pulmonary ventilator-- for consistency.
Claim 1 recites “the time series points” in the last 2 lines, suggested to be changed to --the curve points-- for consistency.
Claims 1 (lines 7-8 and 11) and 5 recite “the algorithm” suggested to be changed to --the predictive time-series algorithm-- for consistency.
Claim 3, line 2, claim 4, lines 2-3 and claim 8, line 1 recites “a pulmonary ventilator” suggested to be changed to --the pulmonary ventilator-- in order to refer back to the recited pulmonary ventilator of claim 1.
Claim 4, line 2 recites “a breathing simulator” suggested to be changed to --the breathing simulator-- in order to refer back to the recited breathing simulator of claim 3. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-11 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 recites “the muscle pressure” in line 1, “the database” in line 2 and the muscle pressure value” in the last line, which lack proper antecedent basis.
Claim 1, line 5 recites “the ventilator” suggested to be changed to --the pulmonary ventilator respiratory cycles-- for clarity.
Claim 1, line 8 and claim 5, line 3 recite “a pulmonary ventilator” however it is unclear if applicant intends to refer back to the pulmonary ventilator or the pulmonary ventilator respiratory cycles.
Claim 3 recites “muscles pressures” in line 4, however it is unclear if applicant is referring back to the muscle pressure from claim 1 or introducing new and different muscle pressures.
Claim 5 recites “the populating step the algorithm with pressure” is confusing language that needs rephrasing.
Claim 5 recites “a point,” “forty points” and “said points” however it is unclear if applicant is referring back to the curve points of claim 1 or introducing new and different points.
Claim 5 recites “the pressure, volume and flow curves,” which lacks proper antecedent basis.
Claim 6 recites “estimating points” however it is unclear if applicant is referring back to the curve points of claim 1 or points in claim 5 or introducing new and different points.
Any remaining claims are rejected as being dependent on a rejected base claim.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-11 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Each of Claims 1-11 have been analyzed to determine whether it is directed to any judicial exceptions.
Step 2A, Prong 1
Each of Claims 1-11 recite at least one step for an estimating muscle pressure of a patient method, which is grouped as a mental process and mathematical concept under the 2019 PEG (see MPEP 2106.04(a)). Accordingly, each of Claims 1-11 recite an abstract idea.
Specifically, independent Claim 1 recites (additional elements are in bold, abstract ideas are underlined):
A method for estimating the muscle pressure of a patient being ventilated by a pulmonary ventilator, said method comprising: creating the database that correlates data on pressure, volume and flow of pulmonary ventilator respiratory cycles with muscle pressure data corresponding to said pressure, volume and flow data of the ventilator; using the database to create a training data set; training a predictive time-series algorithm with the training data set; populating the algorithm with pressure, volume and flow data from a pulmonary ventilator, the pressure, volume and flow data comprising at least one time series with pressure, volume and flow curve points generated by the ventilator; and using the algorithm to estimate the muscle pressure value for at least one of the time series points.
The abstract ideas indicated by the underlined sections involve observation, judgment or evaluation, which is grouped as a mental process under the 2019 PEG.
Accordingly, as indicated above, each of the above-identified claims recites an abstract idea.
Further, dependent Claims 2-11 merely include limitations that either further define the abstract idea (and thus don’t make the abstract idea any less abstract) or amount to no more than generally linking the use of the abstract idea to a particular technological environment or field of use because they’re merely incidental or token additions to the claims that do not alter or affect how the process steps are performed.
Specifically, Claim 2 recites (additional elements are in bold, abstract ideas are underlined): wherein the predictive time-series algorithm is an LSTM (Long Short-Term Memory) recurrent neural network.
Specifically, Claim 3 recites (additional elements are in bold, abstract ideas are underlined): wherein the database covers data obtained with a pulmonary ventilator connected to a breathing simulator, the breathing simulator enabling the simulation of different resistance and elastance parameters and the introduction of muscle pressures having adjustable amplitude and duration.
Specifically, Claim 4 recites (additional elements are in bold, abstract ideas are underlined): wherein the database covers data obtained with a breathing simulator and data obtained with a pulmonary ventilator in operation.
Specifically, Claim 5 recites (additional elements are in bold, abstract ideas are underlined): wherein the populating step the algorithm with pressure, volume and flow data from a pulmonary ventilator comprises populating the data relating to a point, taken in a same time period, in each of the pressure, volume and flow curves and also forty points on each side of said points taken in the same time period.
Specifically, Claim 6 recites (additional elements are in bold, abstract ideas are underlined): wherein the estimating step comprises estimating points of a muscle pressure curve.
Specifically, Claim 7 recites (additional elements are in bold, abstract ideas are underlined): further comprising a post-processing step wherein a two-order Savitzky-Golay filter is applied to the muscle pressure curve.
Specifically, Claim 8 recites (additional elements are in bold, abstract ideas are underlined): An auxiliary device for a pulmonary ventilator, comprising a device trained with the method defined in claim 1.
Specifically, Claim 9 recites (additional elements are in bold, abstract ideas are underlined): wherein said device is connectable to the pulmonary ventilator.
Specifically, Claim 10 recites (additional elements are in bold, abstract ideas are underlined): wherein said device is integrated to the pulmonary ventilator.
Specifically, Claim 11 recites (additional elements are in bold, abstract ideas are underlined): wherein said device is integrated to a vital signs monitor.
Step 2A, Prong 2
The above-identified abstract idea in the independent Claim 1 and its dependent Claims 2-11 are not integrated into a practical application under 2019 PEG because the additional elements (identified above in Claims 1-11), either alone or in combination, generally link the use of the above-identified abstract idea to a particular technological environment or field of use. More specifically, the additional elements of: pulmonary ventilator, breathing simulator, auxiliary device and vital signs monitor as recited in Claims 1, 3-5 and 9-11 do not serve to apply the above-identified abstract idea with, or by use of, a particular machine, effect a transformation or apply or use the above-identified abstract idea in some other meaningful way beyond generally linking the use thereof to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception. Furthermore, the above-identified additional elements do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a computer. For at least these reasons, the abstract idea identified above in Claims 1-11 is not integrated into a practical application under 2019 PEG.
Accordingly, independent Claim 1 and its dependent claims 2-11 are each directed to an abstract idea under 2019 PEG.
Step 2B
None of Claims 1-11 include additional elements that are sufficient to amount to significantly more than the abstract idea for at least the following reasons.
These claims require the additional elements of: pulmonary ventilator, breathing simulator, auxiliary device and vital signs monitor as recited in Claims 11, 3-5 and 9-11.
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 Claims 1, 3-5 and 9-11 do not add significantly more because they are simply an attempt to limit the abstract idea to a particular technological environment. That is, neither the general computer elements nor any other additional element adds meaningful limitations to the abstract idea because these additional elements represent insignificant extra-solution activity. When viewed as a combination, these above-identified additional elements simply instruct the practitioner to implement the claimed functions with well-understood, routine and conventional activity specified at a high level of generality in a particular technological environment. As such, there is no inventive concept sufficient to transform the claimed subject matter into a patent-eligible application. As such, the above-identified additional elements, when viewed as whole, do not provide meaningful limitations to transform the abstract idea into a patent eligible application of the abstract idea such that the claims amount to significantly more than the abstract idea itself. Thus, Claims 1-11 merely apply an abstract idea to a computer and do not provide a technical solution to a problem in a technical field.
Therefore, none of the Claims 1-11 amount to significantly more than the abstract idea itself.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Al-Rawas et al. (2012/0330177) directed towards a system and method for assessing real time pulmonary mechanics, Banner et al. (2014/0276173) directed towards methods and systems for monitoring resistance and work of breathing, Euliano et al. (2012/0215081) directed towards method and apparatus for predicting work of breathing, and Younes (2009/0221926) directed towards a method and device for generating of a signal that reflects respiratory effort.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RACHEL T SIPPEL whose telephone number is (571)270-1481. The examiner can normally be reached M-F 9:00-5:00 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Timothy Stanis can be reached at (571) 272-5139. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/RACHEL T SIPPEL/Primary Examiner, Art Unit 3785
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