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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant’s submission filed on 12/9/2025 has been entered.
Claim Objections
Claim 1 is objected to because of the following informalities:
in claim 1, line 2: a comma should be inserted after “replacement volume”.
Appropriate correction is required.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-6 and 9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by the Article “Noninvasive measurement of stroke volume changes in critically ill patients by means of electrical impedance tomography” (Braun)(previously cited).
First Interpretation
With respect to claim 1, Braun teaches a method for performing hemodynamic assessment using an impedance-based device, prior to an introduction of a replacement volume comprising:
determining a first impedance quantification (determining ΔZHM1 at M1; section 2.3 of Braun) associated with a first region of interest (ROI) in a first impedance image (the ROIH or the ROIL; section 2.2 of Braun) using the impedance-based device, wherein the first impedance image is associated with a first state of a patient prior to an external maneuver (at M1 prior to the fluid challenge via the injection of 500 mL of balanced electrolyte solution; section 2.1 of Braun), wherein the external maneuver causes an intrathoracic pressure change, a simulated replacement volume, or both (section 2.1 of Braun);
performing the external maneuver (the fluid challenge via the injection of 500 mL of balanced electrolyte solution; section 2.1 of Braun);
determining a second impedance quantification (determining ΔZHM2 at M2; section 2.3 of Braun) associated with the first region of interest in a second impedance image (the ROIH or the ROIL; section 2.2 of Braun) using the impedance-based device, wherein the second impedance image is associated with a second state of the patient following the external maneuver (at M2 right after the fluid challenge via the injection of 500 mL of balanced electrolyte solution; section 2.1 of Braun);
receiving at least one parameter associated with the external maneuver (receiving SVRefM2; section 2.3 of Braun); and
determining at least one hemodynamic parameter in consideration of the at least one parameter associated with the external maneuver and a difference between the first impedance quantification and the second impedance quantification (determining the comparison between SVEITM1 and SVRefM1 or the comparison between SVEITM3 and SVRefM3 which considers SVRefM2 and the differences between ΔZHM1 at M1 and ΔZHM2 at M2; section 2.3 of Braun).
With respect to claim 2, Braun teaches that the at least one parameter associated with the maneuver comprises one or more of a positive end-expiratory pressure (PEEP) value, a PEEP change, an inspiration time, an expiration time, a respiratory cycle period, a tidal volume value, a tidal volume change, or a position change (SVRefM2 is the volume of blood pumped from the ventricle per beat which makes it a position change value for the amount of blood; section 2.3 of Braun).
With respect to claim 4, Braun teaches that the at least one parameter associated with the maneuver is received from an external device, from a sensor disposed within the impedance-based device, or from both (the SVRefM2 is the result of the calibration of the impedance-based device or a processor that stores the value; sections 2.2-2.4 of Braun).
With respect to claim 6, Braun teaches that the first ROI is associated with a cardiac region or a lung region, or both (the ROIH or the ROIL; section 2.2 of Braun).
With respect to claim 9, Braun teaches: acquiring a first plurality of electrical impedance signals; reconstructing the first impedance image from the first plurality of electrical impedance signals; acquiring a second plurality of electrical impedance signals; and reconstructing the second impedance image from the second plurality of electrical impedance signals (each of the images were reconstructed; sections 2.2-2.3 of Braun).
Second Interpretation
With respect to claim 1, Braun teaches a method for performing hemodynamic assessment using an impedance-based device, prior to an introduction of a replacement volume comprising:
determining a first impedance quantification (determining ΔZHM1 at M1; section 2.3 of Braun) associated with a first region of interest (ROI) in a first impedance image (the ROIH or the ROIL; section 2.2 of Braun) using the impedance-based device, wherein the first impedance image is associated with a first state of a patient prior to an external maneuver (at M1 prior to the fluid challenge via the injection of 500 mL of balanced electrolyte solution; section 2.1 of Braun), wherein the external maneuver causes an intrathoracic pressure change, a simulated replacement volume, or both (section 2.1 of Braun);
performing the external maneuver (the fluid challenge via the injection of 500 mL of balanced electrolyte solution; section 2.1 of Braun);
determining a second impedance quantification (determining ΔZHM2 at M2; section 2.3 of Braun) associated with the first region of interest in a second impedance image (the ROIH or the ROIL; section 2.2 of Braun) using the impedance-based device, wherein the second impedance image is associated with a second state of the patient following the external maneuver (at M2 right after the fluid challenge via the injection of 500 mL of balanced electrolyte solution; section 2.1 of Braun);
receiving at least one parameter associated with the external maneuver (the ventilator data, the functional ventilation image, or the variation in tidal volume ratios; sections 2.4 and 3 of Braun); and
determining at least one hemodynamic parameter (the fluid responsiveness; section 3 of Braun) in consideration of the at least one parameter associated with the external maneuver (the variation in tidal volume ratios exceeding the 95% limits; section 3 of Braun) and a difference between the first impedance quantification and the second impedance quantification (the difference in SV of more than 15%).
With respect to claim 2, Braun teaches that the at least one parameter associated with the maneuver comprises one or more of a positive end-expiratory pressure (PEEP) value, a PEEP change, an inspiration time, an expiration time, a respiratory cycle period, a tidal volume value, a tidal volume change, or a position change (the ventilator data, the functional ventilation image, or the variation in tidal volume ratios; section 2.4 of Braun).
With respect to claim 3, Braun teaches that the at least one parameter associated with the maneuver is received from one or more of a mechanical ventilation device, a pressure sensor configured to measure a respiratory pressure of the patient, a flow sensor, or a carbon dioxide sensor (the ventilator data or the variation in tidal volume ratios is received from a ventilator; section 2.4 of Braun).
With respect to claim 4, Braun teaches that the at least one parameter associated with the maneuver is received from an external device, from a sensor disposed within the impedance-based device, or from both (the ventilator data or the variation in tidal volume ratios is received from a ventilator; section 2.4 of Braun).
With respect to claim 5, Braun teaches that the method further comprises: determining a respiratory component data from the first impedance quantification and the second impedance quantification determined using the impedance-based device; and generating the at least one parameter associated with the maneuver from the respiratory component data (the functional ventilation image, or the variation in tidal volume ratios from the EIT images; section 2.4 of Braun).
With respect to claim 6, Braun teaches that the first ROI is associated with a cardiac region or a lung region, or both (the ROIH or the ROIL; section 2.2 of Braun).
With respect to claim 9, Braun teaches: acquiring a first plurality of electrical impedance signals; reconstructing the first impedance image from the first plurality of electrical impedance signals; acquiring a second plurality of electrical impedance signals; and reconstructing the second impedance image from the second plurality of electrical impedance signals (each of the images were reconstructed; sections 2.2-2.3 of Braun).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Braun.
Braun teaches that passive leg raising can be a substitute for the fluid challenge since it “could lead to higher variations in SV” (section 4.3 of Braun). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the passive leg raising in place of the fluid challenge since it could lead to higher variations in SV. With respect to claim 7, Braun teaches or suggests that that the maneuver comprises a cardiac pre-load simulation maneuver comprising one or more of a change in a posture of the patient or a change in a position of at least one limb (the passive leg raising of Braun).
Response to Arguments
The Applicant’s arguments filed 12/9/2025 have been fully considered.
Claim objections
There are new grounds of claim objections.
35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph
In view of the claim amendments filed on 12/9/2025, the claim rejections under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, are withdrawn.
35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph
In view of the claim amendments filed on 12/9/2025, the claim rejections under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, are withdrawn.
Prior art rejection based on Braun
There are new grounds of rejection based on new interpretations of Braun.
With respect to the first interpretation, the Applicant asserts:
PNG
media_image1.png
476
1073
media_image1.png
Greyscale
This argument is not persuasive. Claim 1 merely recites “receiving at least one parameter associated with the external maneuver”. The recitation does not place any limitation upon the claimed parameter other than it is associated with the external maneuver. That is, the claim language does not preclude the interpretation that the claimed parameter is another hemodynamic parameter. Also, a parameter being “associated” with the external maneuver merely requires that there is some relation between the parameter and the external maneuver. The value SVRefM2 is a parameter and its value is associated with the external maneuver by virtue of being the reference measurement for M2 which occurs right after the fluid challenge via the injection of 500 mL of balanced electrolyte solution. The claim does not require anything more. For example, the claim does not require that the parameter describes how the fluid challenge is performed or is used as an input into a particular calculation. Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
With respect to the second interpretation, the Applicant asserts:
PNG
media_image2.png
527
1080
media_image2.png
Greyscale
This argument is not persuasive. Claim 1 merely recites “receiving at least one parameter associated with the external maneuver”. The recitation does not place any limitation upon the claimed parameter other than it is associated with the external maneuver. That is, the claim language does not preclude the interpretation that the claimed parameter is a quality-control signal. Also, a parameter being “associated” with the external maneuver merely requires that there is some relation between the parameter and the external maneuver. The ventilator data, a functional ventilation image, or the variation in tidal volume ratio is a parameter and its value is associated with the external maneuver by virtue of being based on measurements taken right after prior to the fluid challenge via the injection of 500 mL of balanced electrolyte solution. The claim does not require anything more. For example, the claim does not require that the parameter characterize the fluid challenge itself or that the parameter be incorporated into a calculation to determine the hemodynamic parameter. Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
In view of the above, the rejections of claim 1 based on both the first and second interpretations are proper.
The rejection of claims 2-7 and 9 are proper because the rejection of claim 1 is proper, Braun teaches all the features of claims 2-6 and 9, and Braun teaches or suggests all the features of claim 7.
Additionally, the calculations of Braun is not being altered such that the principle of operation of Braun is not being altered with respect to the calculations.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MATTHEW KREMER whose telephone number is (571)270-3394. The examiner can normally be reached Monday - Friday 8 am to 6 pm; every other Friday off.
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, JACQUELINE CHENG can be reached at (571) 272-5596. 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.
/MATTHEW KREMER/Primary Examiner, Art Unit 3791