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 .
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 1-2, 6, and 9 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 “a posture of the patient” in line 18, but it is not clear if this recitation is the same as, related to, or different from “a posture of the patient” in claim 1, line 8. If they are the same, “a posture of the patient” in line 18 should be “the posture of the patient”. If they are different, their relationship should be made clear; they should be clearly distinguished from each other (e.g., when multiple elements have similar or the same labels, distinct identifiers such as “first” and “second” should be used to clearly differentiate the elements); and any subsequent recitation of the posture should make it clear which recitation is being referred to.
Claim 1 recites “a position of the at least one limb” in line 18, but it is not clear if this recitation is the same as, related to, or different from “a position of at least one limb” in claim 1, lines 8-9. If they are the same, “a position of the at least one limb” in line 18 should be “the position of the at least one limb”. If they are different, their relationship should be made clear; they should be clearly distinguished from each other (e.g., when multiple elements have similar or the same labels, distinct identifiers such as “first” and “second” should be used to clearly differentiate the elements); and any subsequent recitation of the position of the at least one limb should make it clear which recitation is being referred to.
Claim 1 recites “performance of the cardiac pre-load simulation maneuver” in line 19, but it is not clear if this recitation is the same as, related to, or different from “performing the external maneuver” in claim 1, line 10. If they are the same, “performance of the cardiac pre-load simulation maneuver” in line 19 should be “the performance of the cardiac pre-load simulation maneuver”. If they are different, their relationship should be made clear; they should be clearly distinguished from each other (e.g., when multiple elements have similar or the same labels, distinct identifiers such as “first” and “second” should be used to clearly differentiate the elements); and any subsequent recitation of the performance of the cardiac pre-load simulation maneuver should make it clear which recitation is being referred to.
Claims 2, 6, and 9 are rejected by virtue of their dependence from claim 1.
Claim 2 recites “wherein the at least one parameter associated with the maneuver comprises one or more of bed position data from an automated bed on which the patient is disposed, actual-position data measured by a position sensor in contact with the patient or by a position sensor placed in an automated bed on which the patient is disposed, user-entered position data indicating a posture of the patient or a position of at least one limb of the patient, or relative-limb-position data quantified from a video recording of the patient by an image processing system” in lines 1-9, which renders the claim indefinite.
First, it is not clear if “one or more of bed position data from an automated bed on which the patient is disposed, actual-position data measured by a position sensor in contact with the patient or by a position sensor placed in an automated bed on which the patient is disposed, user-entered position data indicating a posture of the patient or a position of at least one limb of the patient, or relative-limb-position data quantified from a video recording of the patient by an image processing system” is the same as, related to, or different from “position data associated with the cardiac pre-load simulation maneuver” of claim 1, line 17. Both recitations connote that they are comprised in the at least one parameter, but the claim does not make it clear if they are the same thing or the at least one parameter is intended to comprise two different things. This ambiguity renders claim 2 indefinite.
Second, it is not clear if the expression “one or more of” is referring to just “bed position data from an automated bed on which the patient is disposed”1 or is referring to the entire list of “bed position data from an automated bed on which the patient is disposed, actual-position data measured by a position sensor in contact with the patient or by a position sensor placed in an automated bed on which the patient is disposed, user-entered position data indicating a posture of the patient or a position of at least one limb of the patient, or relative-limb-position data quantified from a video recording of the patient by an image processing system”. This ambiguity renders claim 2 indefinite.
Third, it is not clear if “a position sensor” in line 6 is the same as, related to, or different from “a position sensor” in lines 5-6. If they are the same, “a position sensor” in line 6 should be “the position sensor”. If they are different, their relationship should be made clear and they should be clearly distinguished from each other (e.g., when multiple elements have similar or the same labels, distinct identifiers such as “first” and “second” should be used to clearly differentiate the elements).
Fourth, it is not clear if “an automated bed” in line 6 is the same as, related to, or different from “an automated bed” in lines 4-5. If they are the same, “an automated bed” in line 6 should be “the automated bed”. If they are different, their relationship should be made clear and they should be clearly distinguished from each other (e.g., when multiple elements have similar or the same labels, distinct identifiers such as “first” and “second” should be used to clearly differentiate the elements).
Fifth, it is not clear how “actual-position data measured … by a position sensor placed in an automated bed on which the patient is disposed” in lines 5-7 is different from “bed position data from an automated bed on which the patient is disposed” in lines 4-5. It appears a sensor on an automated bed is bed position data, rather than actual-position data, but the claim connotes that such a sensor can be either. This confusion renders claim 2 indefinite.
Sixth, claim 2 recites “a posture of the patient” in line 18, but it is not clear if this recitation is the same as, related to, or different from “a posture of the patient” in claim 1, line 8 and/or “a posture of the patient” in claim 1, line 18. The relationship among these recitations should be made clear.
Sixth, claim 2 recites “a position of at least one limb of the patient” in lines 7-8, but it is not clear if this recitation is the same as, related to, or different from “a position of at least one limb” in claim 1, lines 8-9 and/or “a position of the at least one limb” in claim 1, line 18. Further, it is not clear if “at least one limb of the patient” in lines 7-8 is the same as, related to, or different from “at least one limb” in claim 1, line 9. The relationships among these recitations should be made clear.
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 1-2, 6, and 9 are rejected under 35 U.S.C. 103 as being unpatentable over the Article “Noninvasive measurement of stroke volume changes in critically ill patients by means of electrical impedance tomography” (Braun)(previously cited), in view of U.S. Patent Application Publication No. 2021/0353163 (Whitmarsh).
Braun teaches the performance of an external maneuver (the fluid challenge via the injection of 500 mL of balanced electrolyte solution; section 2.1 of Braun). Braun also 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.
Braun teaches the use of passive leg raising. Whitmarsh teaches the use of an accelerometer and/or a gyroscope as an orientation sensors for measuring the orientation of a limb (paragraphs 0019, 0050 and 0057 of Whitmarsh). Whitmarsh also teaches that a system can use the orientation sensor and its readings to mark the beginning and duration of sensor measurements directed to leg elevation so as to categorize the leg elevation stages for analysis (paragraphs 0075 and 0088 of Whitmarsh). 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 accelerometer and/or the gyroscope of Whitmarsh to mark the time related to the beginning, duration, and ending of the passive leg raising so that the readings at particular leg elevation stages can be identified and used for analysis.
First Interpretation
With respect to claim 1, the combination teaches or suggests teaches a method for performing hemodynamic assessment using an impedance-based device, 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 passive leg raising of Braun; sections 2.1 and 4.3 of Braun), wherein the external 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; sections 2.1 and 4.3 of Braun);
performing the external maneuver (performing the passive leg raising of Braun; sections 2.1 and 4.3 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 passive leg raising of Braun; sections 2.1 and 4.3 of Braun);
receiving at least one parameter associated with the external maneuver (receiving orientation data as suggested by Whitmarsh), the at least one parameter comprising position data associated with the cardiac pre-load simulation maneuver (the orientation data as suggested by Whitmarsh with respect to the passive leg raising of Braun), wherein the position data indicates a posture of the patient or a position of the at least one limb during performance of the cardiac pre-load simulation maneuver (the orientation data as suggested by Whitmarsh with respect to the passive leg raising of Braun); and
determining at least one hemodynamic parameter in consideration of the position data 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; the determination also considers the orientation data since the orientation data is used to demark the times before, during, and after the passive leg raising).
With respect to claim 2, Braun teaches that the at least one parameter associated with the maneuver comprises one or more of bed position data from an automated bed on which the patient is disposed, actual-position data measured by a position sensor in contact with the patient (the orientation data of the leg as provided by the accelerometer and/or gyroscope of Whitmarsh) or by a position sensor placed in an automated bed on which the patient is disposed, user-entered position data indicating a posture of the patient or a position of at least one limb of the patient, or relative-limb-position data quantified from a video recording of the patient by an image processing system.
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, the combination teaches or suggests a method for performing hemodynamic assessment using an impedance-based device, 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 passive leg raising of Braun; sections 2.1 and 4.3 of Braun), wherein the external 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; sections 2.1 and 4.3 of Braun);
performing the external maneuver (the passive leg raising of Braun; sections 2.1 and 4.3 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 passive leg raising of Braun; sections 2.1 and 4.3 of Braun);
receiving at least one parameter associated with the external maneuver (receiving orientation data as suggested by Whitmarsh), the at least one parameter comprising position data associated with the cardiac pre-load simulation maneuver (the orientation data as suggested by Whitmarsh with respect to the passive leg raising of Braun), wherein the position data indicates a posture of the patient or a position of the at least one limb during performance of the cardiac pre-load simulation maneuver (the orientation data as suggested by Whitmarsh with respect to the passive leg raising of Braun); and
determining at least one hemodynamic parameter (the fluid responsiveness; section 3 of Braun) in consideration of the position data and a difference between the first impedance quantification and the second impedance quantification (the difference in SV of more than 15%; the determination also considers the orientation data since the orientation data is used to demark the times before, during, and after the passive leg raising).
With respect to claim 2, Braun teaches that the at least one parameter associated with the maneuver comprises one or more of bed position data from an automated bed on which the patient is disposed, actual-position data measured by a position sensor in contact with the patient (the orientation data of the leg as provided by the accelerometer and/or gyroscope of Whitmarsh) or by a position sensor placed in an automated bed on which the patient is disposed, user-entered position data indicating a posture of the patient or a position of at least one limb of the patient, or relative-limb-position data quantified from a video recording of the patient by an image processing system.
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).
Response to Arguments
The Applicant’s arguments filed 5/22/2026 have been fully considered.
Claim objections
In view of the claim amendments filed on 5/22/2026, the previous claim objections are withdrawn.
35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph
There are new grounds of claim rejections under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, that were necessitated by the claim amendments filed on 5/22/2026.
Prior art rejections
The Applicant’s arguments with respect to the rejection of claims 1, 2, 6, and 9 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. That is, there are new grounds of rejections that were necessitated by the claim amendments filed on 5/22/2026.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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.
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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.
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/MATTHEW KREMER/Primary Examiner, Art Unit 3791
1 Although the term “data” is used in casual conversation to be singular; grammatically speaking, “data” is actually plural with the expression “datum” being the singular expression.
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