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 .
Response to Arguments
Applicant’s arguments, see Pages 5 & 6, filed 09/11/2025, with respect to claims 1-4 have been fully considered and are persuasive. The rejection of claims 1-4 has been withdrawn.
Claim Objections
Claim 1 is objected to because of the following informalities: In line 1 of claim 1, the “c’ of “Cc” should be subscript for consistency. The limitation will be read as “Cc” upon further examination. 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 1-4 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.
In regards to line 6 of claim 1, it is unclear whether the term “compliance” stands alone or is in reference to the cavity in line 1. The limitation will be read as “…calculation of the compliance of the cavity Cc using the equation…” upon further examination.
In regards to line 2 of claim 4, the phrase “a fluid” is unclear. Is there an additional “fluid” being taken and supplied, or is the “fluid” the same as recited in line 3 of claim 1? The limitation will be read as “…from which the fluid is taken and supplied…” upon further examination.
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 1-3 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Claim 1 recites a method for determining compliance of a cavity by controlling the introduction of a fluid and calculating the compliance of the cavity using the equation Cc = Vc/pc which is a mathematical concept which describes the relationship between volume and pressure.
This judicial exception is not integrated into a practical application because the claim is directed to an abstract idea with additional generic computer elements, and the generically recited computer elements do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a computer. The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception because the additional limitations only store and retrieve information in memory and these are well-understood, routine, conventional computer functions as recognized by the court decisions listed in MPEP § 2106.05(d). (See Flook, 437 U.S. at 591-92, 198 USPQ2d at 198 ("the novelty of the mathematical algorithm is not a determining factor at all”) Also See MPEP 2016.04(a)(2) I. Mathematical Concepts.
Claim 2 recites the method for determining compliance of a cavity by introducing a temporally offset of two defined fluid volumes into the cavity and calculating a partial pressure increase using equation (dpc/dVc) which is a mathematical concept which describes the relationship between volume and pressure.
This judicial exception is not integrated into a practical application because the claim is directed to an abstract idea with additional generic computer elements, and the generically recited computer elements do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a computer. The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception because the additional limitations only store and retrieve information in memory and these are well-understood, routine, conventional computer functions as recognized by the court decisions listed in MPEP § 2106.05(d). (See Flook, 437 U.S. at 591-92, 198 USPQ2d at 198 ("the novelty of the mathematical algorithm is not a determining factor at all”) Also See MPEP 2016.04(a)(2) I. Mathematical Concepts.
Claim 3 recites the method for determining compliance of a cavity by determining a leakage volumetric flow q1 before the single or multiple measurements of the volume introduced into the cavity and of the cavity pressure resulting therefrom and by taking into account the leakage volumetric flow q1 when calculating Cc using the equation (ΔCc=(ΔVc-q1)/Δpc)I which is a mathematical concept which describes the relationship between volume and pressure.
This judicial exception is not integrated into a practical application because the claim is directed to an abstract idea with additional generic computer elements, and the generically recited computer elements do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a computer. The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception because the additional limitations only store and retrieve information in memory and these are well-understood, routine, conventional computer functions as recognized by the court decisions listed in MPEP § 2106.05(d). (See Flook, 437 U.S. at 591-92, 198 USPQ2d at 198 ("the novelty of the mathematical algorithm is not a determining factor at all”) Also See MPEP 2016.04(a)(2) I. Mathematical Concepts.
Allowable Subject Matter
Claims 1-3 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 101 and 112 set forth in this Office Action.
Claim 4 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is an examiner’s statement of reasons for allowance: In the Examiner’s opinion in regards to claim 4, Jafari et al (US 20100236555 A1) teaches a method of compensating for leakage in a ventilation tubing system (26) during delivery of gas from a medical ventilator (20) to a patient (24). The method includes measuring leakage from the ventilation tubing system (26) during a first breath and calculating a leak-compensated delivered lung volume for the first breath based on the leakage. The method then estimates a lung compliance of the patient (24) based on the leak-compensated delivered lung volume and pressure measurements taken during the first breath. Ventilation is then delivered to the patient (24) in a second breath at a pressure determined based on a desired delivered lung volume, the leak-compensated delivered lung volume and the leak-compensated lung compliance. As part of measuring the leakage, the method may include identifying an inelastic leakage from the ventilation tubing system (26) as a first function of at least one of a pressure measurement and a flow measurement in the ventilation system (26) and identifying an elastic leakage from the ventilation tubing system (26) as a second function of at least one of the pressure measurement and the flow measurement in the ventilation system (26) (Paragraphs 0018-24).
However, Jafari et al does not teach the structural limitations of the device for determining compliance of a cavity using a medical-technical device further comprising at least one pressure sensor for determining the dynamic and static pressure of the fluid, at least one electronic storage element that serves for detecting measurement data, and at least one electronic computing unit (e.g., microcontroller) to carry out the determination for supplying necessary control commands to the actuators and to load parameter data sets from the storage element where the stated limitations are not suggested in addition to not being anticipated or taught in combination with the remaining limitations of dependent claim 4 and independent claim 1 upon overcoming the rejection under 35 U.S.C. 101.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Rovatti et al (US 11701463 B2) - The present invention relates to an infusion set for measuring vital signals of a patient. In more detail, the invention refers to an infusion set for measuring vital signals of a patient comprising a compliance element and a reflective element.
Bharucha et al (US 10194813 B2) – The present invention relates to systems, devices and methods that can be used to obtain objective pressure measurements in a body cavity using one or more monitoring bladders mounted on a catheter. The monitoring bladders may be adapted to connect or be connected to a system capable of providing objective pressure measurements indicative of the compressive forces acting on the one or more monitoring bladder in the body cavity. The body cavity may include, for example, the rectum, esophagus, stomach, intestine, colon, reproductive tract, urethra, oronasopharnygeal tract, etc.
Liu et al (US 20220218928 A1) - The disclosure relates to a medical device, and in particular, to a method for evaluating volume responsiveness.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JERMAINE L JENKINS whose telephone number is (571)272-2179. The examiner can normally be reached M-F 7-3 EST.
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/J.L.J/Examiner, Art Unit 2855
/PETER J MACCHIAROLO/Supervisory Patent Examiner, Art Unit 2855