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 .
Status of Claims
Applicant's arguments, filed 06/11/2026, have been fully considered. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Applicants have amended their claims, filed 06/11/2026, and therefore rejections newly made in the instant office action have been necessitated by amendment.
Applicants have amended claims 1, 6, 16, and 18-20.
Applicants have left claims 2, 3, 7-15, and 17 as originally filed/previously presented.
Applicants have canceled/previously canceled claims 4 and 5.
Applicants have introduced new claims 21 and 22.
Claims 1-3 and 6-22 are the current claims hereby under examination.
Claim Objections - Newly Applied Necessitated by Applicant’s Amendments
Claims 1, 7-11, 13, and 16 are objected to because of the following informalities:
Regarding claim 1, line 9 recites “the sensors”, however it appears it should read --the plurality of sensors-- (emphasis added) to maintain consistent claim language.
Regarding claim 1, lines 11-12 recite “the sensors”, however it appears it should read --the plurality of sensors-- (emphasis added) to maintain consistent claim language.
Regarding claim 1, line 20 recites “the sensors”, however it appears it should read --the plurality of sensors-- (emphasis added) to maintain consistent claim language.
Regarding claim 1, line 24 recites “the sensors”, however it appears it should read --the plurality of sensors-- (emphasis added) to maintain consistent claim language.
Regarding claim 7, line 2 recites “the at least four sensors”, however it appears it should read --the plurality of sensors-- (emphasis added) to maintain consistent claim language.
Regarding claim 8, lines 1-2 recite “the at least four sensors”, however it appears it should read --the plurality of sensors-- (emphasis added) to maintain consistent claim language.
Regarding claim 9, lines 1-2 recite “the at least four sensors”, however it appears it should read --the plurality of sensors-- (emphasis added) to maintain consistent claim language.
Regarding claim 10, lines 1-2 recite “the at least four sensors”, however it appears it should read --the plurality of sensors-- (emphasis added) to maintain consistent claim language.
Regarding claim 11, lines 1-2 recite “the at least four sensors”, however it appears it should read --the plurality of sensors-- (emphasis added) to maintain consistent claim language.
Regarding claim 11, line 3 recites “the at least four sensors”, however it appears it should read --the plurality of sensors-- (emphasis added) to maintain consistent claim language.
Regarding claim 13, line 4 recites “the at least four sensors”, however it appears it should read --the plurality of sensors-- (emphasis added) to maintain consistent claim language.
Regarding claim 16, line 9 recites “the sensors”, however it appears it should read --the plurality of sensors-- (emphasis added) to maintain consistent claim language.
Regarding claim 16, line 19 recites “the sensors”, however it appears it should read --the plurality of sensors-- (emphasis added) to maintain consistent claim language.
Regarding claim 16, line 23 recites “the sensors”, however it appears it should read --the plurality of sensors-- (emphasis added) to maintain consistent claim language.
Regarding claim 16, line 24 recites “the sensors”, however it appears it should read --the plurality of sensors-- (emphasis added) to maintain consistent claim language.
Regarding claim 16, line 32 recites “the sensors”, however it appears it should read --the plurality of sensors-- (emphasis added) to maintain consistent claim language.
Regarding claim 16, line 35 recites “the sensors”, however it appears it should read --the plurality of sensors-- (emphasis added) to maintain consistent claim language.
Claim Rejections - 35 USC § 112 - Withdrawn
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.
Response to Arguments
Applicant’s arguments, see page 10 of Remarks, filed 06/11/2026, with respect to claims 1-20 have been fully considered and are persuasive. Applicants have amended the claims, rendering the 112(b) rejections moot. The 112(b) rejections of claims 1-20 has been withdrawn.
Claim Rejections - 35 USC § 101 - Withdrawn and Newly Applied Necessitated by Applicant’s Amendments
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 1-3 and 6-22 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, lines 25-26 recite “an external position sensor in communication with the controller and connected to an external surface of the human body”, which is directed to or encompasses a human organism. It is recommended to the Applicant to amend the claim to read along the lines of --an external position sensor in communication with the controller and configured to be connected to an external surface of the human body-- (emphasis added).
The dependent claims of the above rejected claim are rejected due to their dependency.
Regarding claim 16, lines 26-27 recite “an external position sensor in communication with the controller and connected to an external surface of the human body”, which is directed to or encompasses a human organism. It is recommended to the Applicant to amend the claim to read along the lines of --an external position sensor in communication with the controller and configured to be connected to an external surface of the human body-- (emphasis added).
The dependent claims of the above rejected claim are rejected due to their dependency.
Response to Arguments
Applicant’s arguments, see page 10 of Remarks, filed 06/11/2026, with respect to claims 16-20 have been fully considered and are persuasive. Applicants have amended the claims, rendering the previous 101 rejections moot. The 101 rejections of claims 16-20 has been withdrawn. However, Applicant’s amendments have necessitated new grounds of rejection.
Claim Rejections - 35 USC § 103 - Newly Applied Necessitated by Applicant’s Amendments
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1, 3, 6-16, and 18-22 are rejected under 35 U.S.C. 103 as being unpatentable over Glover et al. (US 20170027458 A1) (previously cited), hereinafter referred to as Glover, in view of Mitchell et al. (US 20250099039 A1) (previously cited), hereinafter referred to as Mitchell, in view of Larson et al. (US 20160296160 A1), hereinafter referred to as Larson.
The claims are generally directed towards a fluid monitoring apparatus for a venous system of a human body, comprising: a catheter tube insertable into a blood vessel of the venous system of the human body and configured to have a fluid from the blood vessel enter and exit the catheter tube, wherein the catheter tube comprises at least one lumen; and wherein the catheter tube has a first end and a second end that has a round shape; a plurality of sensors attached to an internal surface of the catheter tube, wherein the sensors are in contact with the fluid upon the catheter tube inserted in the blood vessel, wherein the sensors are disposed at the second end of the catheter tube and wherein the sensors are at least four selected from the group consisting of a first pressure sensor, a fluid movement sensor, a vasodilation detector, a second pressure sensor, and a volume sensor, wherein the sensors are disposed in tandem in a respective order of the first pressure sensor, the fluid movement sensor, the vasodilation detector, the second pressure sensor and the volume sensor, with the first pressure sensor being the closest to the second end of the catheter tube; a controller communicatively coupled to the sensors; and an external position sensor in communication with the controller and connected to an external surface of the human body, wherein the external position sensor is configured to sense a change in position of the human body, wherein the change in position comprises trendelenburg position and reverse trendelenburg position.
Regarding claim 1, Glover discloses a fluid monitoring apparatus for a venous system of a human body (Abstract, Fig. 6, Fig. 9), comprising:
a catheter tube insertable into a blood vessel of the venous system of the human body and configured to have a fluid from the blood vessel enter and exit the catheter tube (Fig. 6, Fig. 9, element 2002, para. [0080], “catheter tubing …”, para. [0081], “apertures … allow for fluid contact with the optical pressure sensors …”, para. [0091], “placement of the multi-sensor catheter … introduced into the heart …”), wherein the catheter tube comprises at least one lumen (para. [0080], “sensor … individual lumen … of the multi-lumen catheter …”), and
wherein the catheter tube has a first end and a second end that has a round shape (Fig. 6, Fig. 7, - element 2002 has a first end closest to element 2006 and a second end closest to element 2012-7, the entire catheter tube has a cross section that is a round shape);
a plurality of sensors attached to an internal surface of the catheter tube (Fig. 6, elements P1, P2, P3, T, para. [0080], “positioning of the optical sensors within the catheter tubing … each of these lumens have a respective distal aperture … for fluid contact …”, para. [0110], “secure the sensor at the appropriate sensor location”),
wherein the sensors are in contact with the fluid upon the catheter tube inserted in the blood vessel, wherein the sensors are disposed at the second end of the catheter tube (Fig. 6, elements P1, P2, P3, T, para. [0080], “positioning of the optical sensors within the catheter tubing … each of these lumens have a respective distal aperture … for fluid contact …”, para. [0081]) and wherein the sensors are at least four selected from the group consisting of
a first pressure sensor (Fig. 6, element P1, para. [0081], “pressure sensors at sensor positions P1 … distal end portion …”),
a second pressure sensor (Fig. 6, element P2 or P3, para. [0081], “pressure sensors at sensor positions … P2, P3 …”),
wherein the sensors are disposed in tandem in a respective order of the first pressure sensor, the second pressure sensor, with the first pressure sensor being the closest to the second end of the catheter tube (Fig. 6, element P1, para. [0081], “pressure sensors at sensor positions P1 … distal end portion …”, para. [0081], “pressure sensors at sensor positions … P2, P3 …”);
a controller communicatively coupled to the sensors (Fig. 5, element 2151, para. [0075], “control unit”, para. [0083], “four optical sensors … connects … control unit … houses a control system comprising a controller …”).
However, Glover does not explicitly disclose the sensors are at least four selected from the group consisting of a fluid movement sensor, a vasodilation detector, and a volume sensor.
Mitchell teaches an analogous fluid monitoring apparatus for a venous system of a human body (Abstract, Fig. 11A, para. [0002]). Mitchell teaches the apparatus includes a catheter tube insertable into a blood vessel of the venous system of the human body (Fig. 11A, para. [0040]). Mitchell teaches at least four sensors attached to an internal surface of the catheter tube (Fig. 11A, elements 1106, para. [0040]). Mitchel further teaches the sensors are at least four selected from the group consisting of a fluid movement sensor, a vasodilation detector, and a volume sensor (para. [0039], “multi sensors are used, the different sensors can … comprise different types of sensors … impedance sensor, a pressure sensor, an optical sensor, a flow sensor, an ultrasonic transducer, a PPG sensor, a chemical sensor, a movement sensor, an electrochemical sensor …”). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the sensors disclosed by Glover to additionally include a fluid movement sensor, a vasodilation detector, and a volume sensor, as taught by Mitchell. This is because Mitchell teaches different sensors, such as fluid movement sensors, vasodilation sensors, and volume sensors, in combination with pressure sensors, allow for multiple physiological parameters to be determined with a single device (para. [0029]).
However, modified Glover does not explicitly disclose the respective order is the first pressure sensor, the fluid movement sensor, the vasodilation detector, the second pressure sensor and the volume sensor.
Mitchell further teaches the multiple different sensors can be located at different portions of the lumen based on the desired location within the coronary sinus and/or the desired sensor measurement (para. [0039]). As such, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the respective order and the first pressure sensor and the second pressure sensor disclosed by Glover to explicitly be in an order of the first pressure sensor, the fluid movement sensor, the vasodilation detector, the second pressure sensor and the volume sensor as an obvious matter of design choice and desired sensor measurement parameter (see MPEP 2144.04, VI, C).
However, modified Glover does not explicitly disclose an external position sensor in communication with the controller and connected to an external surface of the human body, wherein the external position sensor is configured to sense a change in position of the human body, wherein the change in position comprises trendelenburg position and reverse trendelenburg position.
Larson teaches an analogous system for monitoring a patient (Abstract). Larson further teaches an external position sensor in communication with a controller and connected to an external surface of the human body (para. [0014], para. [0058]). Larson further teaches the external position sensor is configured to sense a change in position of the human body, wherein the change in position comprises trendelenburg position and reverse trendelenburg position (para. [0014], para. [0075-0076]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system taught by modified Glover to additionally include an external position sensor in communication with the controller and connected to an external surface of the human body, wherein the external position sensor is configured to sense a change in position of the human body, wherein the change in position comprises trendelenburg position and reverse trendelenburg position, as taught by Larson. This is because Larson teaches determining an orientation of the patient, specifically a trendelenburg position and reverse trendelenburg position allows for optimization of signals to be performed (para. [0014]).
Regarding claim 3, modified Glover discloses the fluid monitoring apparatus of claim 1, wherein each of the first pressure sensor and the second pressure sensor are at least one of a piezo-resistive sensor, photo-electric sensor and a photo-optic sensor (para. [0084], “optical pressure sensors …”).
However, modified Glover does not explicitly disclose wherein the fluid movement sensor is at least one of an electromagnetic sensor and an electrochemical sensor, wherein the vasodilation detector is at least one of a capacitive strain gauge sensor or a bio-impedance sensor, and wherein the volume sensor is at least one of a photoplethysmography (PPG) sensor and an electromagnetic sensor.
Mitchell further teaches the fluid movement sensor is at least one of an electromagnetic sensor and an electrochemical sensor, wherein the vasodilation detector is at least one of a capacitive strain gauge sensor or a bio-impedance sensor, and wherein the volume sensor is at least one of a photoplethysmography (PPG) sensor and an electromagnetic sensor (para. [0039], “impedance sensor … PPG sensor … electrochemical sensor …”). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the sensors to include at least one of an electromagnetic sensor and an electrochemical sensor, at least one of a capacitive strain gauge sensor or a bio-impedance sensor, and at least one of a photoplethysmography (PPG) sensor and an electromagnetic sensor, as taught by Mitchell. This is because Mitchell teaches multiple physiological sensors allow for multiple physiological parameters to be determined with a single device (para. [0029]), and these sensors are known for sensing physiological parameters (para. [0039]).
Regarding claim 6, modified Glover discloses the fluid monitoring apparatus of claim 1.
However, modified Glover does not explicitly disclose an external cable connected between the external position sensor and the controller.
Larson further teaches an external cable connected between the external position sensor and the controller (para. [0058], “sensor … microprocessor … communications with a base station/host … wired …”). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the external position sensor and the controller taught by modified Glover to additionally be connected by an external cable, as taught by Larson. This is because Larson teaches a wired connection is a reliable and known method of data transfer (para. [0058]).
Regarding claim 7, modified Glover discloses the fluid monitoring apparatus of claim 1, further comprising a plurality of cables connected between the at least four sensors attached to the catheter tube and the controller (Fig. 5, Fig. 6, para. [0080], “optical sensor … optically coupled to a respective individual optical fiber …”, para. [0083], “optical coupling … to the control unit …”).
Regarding claim 8, modified Glover discloses the fluid monitoring apparatus of claim 1.
However, modified Glover does not explicitly disclose wherein each of the at least four sensors has a length in a range from 1 cm up to 3 cm.
Glover does clearly teach the variability of the dimensions and dimensional relationships of the components, which suggests that the dimensions can be optimized based on manufacturing, design, and use applications. For example, Glover teaches the diameter of the catheter tubing can vary depending on the desired gauge (para. [0075], para. [0087]), and depending on the sensor, the sensor diameter can have multiple different diameters (para. [0084-0085]). As such, the dimensions and dimensional relationships of the components are results-effective variables that would have been optimized through routine experimentation based on the manufacturing, design, and use applications. The actual size of the sensors depends upon the desired type of sensor and the desired gauge of the catheter. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to select the dimensions and dimensional relationships of the components, using the teachings of Glover as a starting point, so as to obtain the desired manufacturing, design, and use applications.
Regarding claim 9, modified Glover discloses the fluid monitoring apparatus of claim 1.
However, modified Glover does not explicitly disclose wherein each of the at least four sensors has an external diameter in a range from 1 mm up to 2 mm.
Glover does clearly teach the variability of the dimensions and dimensional relationships of the components, which suggests that the dimensions can be optimized based on manufacturing, design, and use applications. For example, Glover teaches the diameter of the catheter tubing can vary depending on the desired gauge (para. [0075], para. [0087]), and depending on the sensor, the sensor diameter can have multiple different diameters (para. [0084-0085]). As such, the dimensions and dimensional relationships of the components are results-effective variables that would have been optimized through routine experimentation based on the manufacturing, design, and use applications. The actual external diameter of the sensors depends upon the desired type of sensor and the desired gauge of the catheter. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to select the dimensions and dimensional relationships of the components, using the teachings of Glover as a starting point, so as to obtain the desired manufacturing, design, and use applications.
Regarding claim 10, modified Glover discloses the fluid monitoring apparatus of claim 1.
However, modified Glover does not explicitly disclose wherein each of the at least four sensors has an external diameter up to 0.9 times of a diameter of the catheter tube.
Glover does clearly teach the variability of the dimensions and dimensional relationships of the components, which suggests that the dimensions can be optimized based on manufacturing, design, and use applications. For example, Glover teaches the diameter of the catheter tubing can vary depending on the desired gauge (para. [0075], para. [0087]), and depending on the sensor, the sensor diameter can have multiple different diameters (para. [0084-0085]). As such, the dimensions and dimensional relationships of the components are results-effective variables that would have been optimized through routine experimentation based on the manufacturing, design, and use applications. The external diameter of the sensor in relation to the diameter of the catheter tube depends upon the desired type of sensor and the desired gauge of the catheter. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to select the dimensions and dimensional relationships of the components, using the teachings of Glover as a starting point, so as to obtain the desired manufacturing, design, and use applications.
Regarding claim 11, modified Glover discloses the fluid monitoring apparatus of claim 1, wherein the at least four sensors are longitudinally spaced apart from one another inside the catheter tube (Fig. 6, para. [0081], “sensor positions … spaced by distances …”), wherein a flexible separator is present between each sensor of the at least four sensors, wherein the flexible separator comprises a flexible cellular polymer (Fig. 7, Fig. 8, para. [0075], “seven lumens …”, para. [0086], “multi-lumen catheter is a flexible polymer …”).
Regarding claim 12, modified Glover discloses the fluid monitoring apparatus of claim 1, wherein the catheter tube is made of a flexible material (para. [0086], “flexible polymer …”).
Regarding claim 13, modified Glover discloses the fluid monitoring apparatus of claim 1, wherein the catheter tube comprises an insertion port having a length of at least 1 cm at the insertable tip of the catheter tube for insertion of a guidewire from a center point of the insertion port and along an edge of the at least four sensors attached to the catheter tube (Fig. 6, para. [0076], “110 cm in length …”, para. [0079], “central lumen … internal diameter which is sized to receive a standard guidewire …”).
Regarding claim 14, modified Glover discloses the fluid monitoring apparatus of claim 1, wherein the catheter tube is a central venous catheter (Fig. 9, para. [0076]).
Regarding claim 15, modified Glover discloses the fluid monitoring apparatus of claim 1, wherein the catheter tube is integrated into an intra-aortic balloon pump (Fig. 6, element 2160, para. [0079]).
Regarding claim 16, Glover discloses a fluid management system for an invasive monitoring of a venous system of a human body (Abstract, Fig. 6, Fig. 9), comprising:
a catheter tube insertable into a blood vessel of the venous system of the human body through a guidewire, wherein the catheter tube comprises at least one lumen, wherein a fluid from the blood vessel is configured to enter and exit the catheter tube (Fig. 6, Fig. 9, element 2002, para. [0079-0080], “guidewire … facilitate insertion of the catheter”, para. [0080], “catheter tubing …”, para. [0081], “apertures … allow for fluid contact with the optical pressure sensors …”, para. [0091], “placement of the multi-sensor catheter … introduced into the heart …”), wherein the catheter tube comprises at least one lumen (para. [0080], “sensor … individual lumen … of the multi-lumen catheter …”), and
wherein the catheter tube comprises a first end and a second end that is rounded (Fig. 6, Fig. 7, - element 2002 has a first end closest to element 2006 and a second end closest to element 2012-7, the entire catheter tube has a cross section that is a round shape);
a plurality of sensors attached to an internal surface of the catheter tube and configured to be in contact with the fluid upon the catheter tube inserted in the blood vessel (Fig. 6, elements P1, P2, P3, T, para. [0080], “positioning of the optical sensors within the catheter tubing … each of these lumens have a respective distal aperture … for fluid contact …”, para. [0081]), wherein the sensors are at least four selected from
a first pressure sensor (Fig. 6, element P1, para. [0081], “pressure sensors at sensor positions P1 … distal end portion …”, para. [0090]),
a second pressure sensor (Fig. 6, element P2 or P3, para. [0081], “pressure sensors at sensor positions … P2, P3 …”),
wherein the sensors are disposed in tandem at the second end of the catheter tube in a respective order of the first pressure sensor, the second pressure sensor, with the first pressure sensor being the closest to the second end (Fig. 6, element P1, para. [0081], “pressure sensors at sensor positions P1 … distal end portion …”, para. [0081], “pressure sensors at sensor positions … P2, P3 …”);
a controller communicatively coupled to the sensors configured to receive a measurement value from each of the sensors and to assess a fluid requirement of the human body (Fig. 5, element 2151, para. [0075], “control unit”, para. [0083], “four optical sensors … connects … control unit … houses a control system comprising a controller … display of sensor data”);
a plurality of cables extending from the catheter tube to the controller configured to conduct communication between the sensors and the controller (Fig. 5, Fig. 6, para. [0080], “optical sensor … optically coupled to a respective individual optical fiber …”, para. [0083], “optical coupling … to the control unit …”); and
an insertion port having a length of at least 1 cm at the insertable tip of the catheter tube for insertion of the guidewire from a center point of the insertion port and along an edge of the sensors attached to the catheter tube (Fig. 6, para. [0076], “110 cm in length …”, para. [0079], “central lumen … internal diameter which is sized to receive a standard guidewire …”).
However, Glover does not explicitly disclose the sensors additionally comprise a fluid movement sensor, a vasodilation detector, and a volume sensor.
Mitchell teaches an analogous fluid monitoring apparatus for a venous system of a human body (Abstract, Fig. 11A, para. [0002]). Mitchell teaches the apparatus includes a catheter tube insertable into a blood vessel of the venous system of the human body (Fig. 11A, para. [0040]). Mitchell teaches at least four sensors attached to an internal surface of the catheter tube (Fig. 11A, elements 1106, para. [0040]). Mitchel further teaches the sensors are at least four selected from the group consisting of a fluid movement sensor, a vasodilation detector, and a volume sensor (para. [0039], “multi sensors are used, the different sensors can … comprise different types of sensors … impedance sensor, a pressure sensor, an optical sensor, a flow sensor, an ultrasonic transducer, a PPG sensor, a chemical sensor, a movement sensor, an electrochemical sensor …”). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the sensors disclosed by Glover to additionally include a fluid movement sensor, a vasodilation detector, and a volume sensor, as taught by Mitchell. This is because Mitchell teaches different sensors, such as fluid movement sensors, vasodilation sensors, and volume sensors, in combination with pressure sensors, allow for multiple physiological parameters to be determined with a single device (para. [0029]).
However, modified Glover does not explicitly disclose the respective order is the first pressure sensor, the fluid movement sensor, the vasodilation detector, the second pressure sensor and the volume sensor.
Mitchell further teaches the multiple different sensors can be located at different portions of the lumen based on the desired location within the coronary sinus and/or the desired sensor measurement (para. [0039]). As such, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the respective order and the first pressure sensor and the second pressure sensor disclosed by Glover to explicitly be in an order of the first pressure sensor, the fluid movement sensor, the vasodilation detector, the second pressure sensor and the volume sensor as an obvious matter of design choice and desired sensor measurement parameter (see MPEP 2144.04, VI, C).
However, modified Glover does not explicitly disclose an external position sensor in communication with the controller and connected to an external surface of the human body, wherein the external position sensor is configured to sense a change in position of the human body, wherein the change in position comprises trendelenburg position and reverse trendelenburg position.
Larson teaches an analogous system for monitoring a patient (Abstract). Larson further teaches an external position sensor in communication with a controller and connected to an external surface of the human body (para. [0014], para. [0058]). Larson further teaches the external position sensor is configured to sense a change in position of the human body, wherein the change in position comprises trendelenburg position and reverse trendelenburg position (para. [0014], para. [0075-0076]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system taught by modified Glover to additionally include an external position sensor in communication with the controller and connected to an external surface of the human body, wherein the external position sensor is configured to sense a change in position of the human body, wherein the change in position comprises trendelenburg position and reverse trendelenburg position, as taught by Larson. This is because Larson teaches determining an orientation of the patient, specifically a trendelenburg position and reverse trendelenburg position allows for optimization of signals to be performed (para. [0014]).
Regarding claim 18, modified Glover discloses the fluid management system of claim 16, wherein the second pressure sensor is configured to measure and communicate a pressure of the fluid against a wall of the blood vessel to the controller (Fig. 6, element P2 or P3, para. [0081], “pressure sensors at sensor positions … P2, P3 …”, para. [0090]).
Regarding claim 19, modified Glover discloses the fluid management system of claim 16.
However, modified Glover does not explicitly disclose wherein the controller is connected to the external position sensor through an external cable.
Larson further teaches a controller is connected to the external position sensor through an external cable (para. [0058], “sensor … microprocessor … communications with a base station/host … wired …”). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the external position sensor and the controller taught by modified Glover to additionally be connected by an external cable, as taught by Larson. This is because Larson teaches a wired connection is a reliable and known method of data transfer (para. [0058]).
Regarding claim 20, modified Glover discloses the fluid management system of claim 19.
However, modified Glover does not explicitly disclose wherein the external position sensor is configured to communicate a change in an orientation of the human body to the controller.
Larson further teaches the external position sensor is configured to communicate a change in an orientation of the human body to the controller (para. [0014], para. [0075-0076]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system taught by modified Glover to additionally communicate a change in an orientation of the human body to the controller, as taught by Larson. This is because Larson teaches determining an orientation change of the patient, specifically a trendelenburg position and reverse trendelenburg position allows for optimization of signals to be performed (para. [0014]).
Regarding claim 21, modified Glover discloses the fluid monitoring apparatus of claim 1.
However, modified Glover does not explicitly disclose wherein the external position sensor is configured to report data related to the change in position to the controller.
Larson further teaches the external position sensor is configured to report data related to the change in position to the controller (para. [0014], para. [0075-0076]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system taught by modified Glover to additionally report data related to the change in position to the controller, as taught by Larson. This is because Larson teaches determining an orientation change of the patient, specifically a trendelenburg position and reverse trendelenburg position allows for optimization of signals to be performed (para. [0014]).
Regarding claim 22, modified Glover discloses the fluid monitoring apparatus of claim 21.
However, modified Glover does not explicitly disclose wherein the change in position is a move from the trendelenburg position to the reverse trendelenburg position.
Larson further teaches the change in position is a move from the trendelenburg position to the reverse trendelenburg position (para. [0014], para. [0075-0076]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system taught by modified Glover to additionally report the change in position is from the trendelenburg position to the reverse trendelenburg position, as taught by Larson. This is because Larson teaches determining an orientation change of the patient, specifically a trendelenburg position and reverse trendelenburg position allows for optimization of signals to be performed (para. [0014]).
Claims 2 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Glover et al. (US 20170027458 A1) (previously cited), hereinafter referred to as Glover, in view of Mitchell et al. (US 20250099039 A1) (previously cited), hereinafter referred to as Mitchell, in view of Larson et al. (US 20160296160 A1), hereinafter referred to as Larson as applied to claims 1 and 16 above, and further in view of McCaffrey et al. (US 20150133800 A1) (previously cited), hereinafter referred to as McCaffrey.
Regarding claim 2, modified Glover discloses the fluid monitoring apparatus of claim 1.
However, modified Glover does not explicitly disclose wherein the controller further comprises a transducer in communication with the first pressure sensor and the second pressure sensor.
McCaffrey reaches an analogous fluid monitoring apparatus for a venous system of a human body, including a catheter and a pressure sensor (Fig. 3A, para. [0039]). McCaffrey further teaches a controller comprises a transducer in communication with the pressure sensor (para. [0047]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the controller taught by modified Glover to additionally include a transducer in communication with the first pressure sensor and the second pressure sensor, as taught by McCaffrey. This is because McCaffrey teaches a transducer allows for certain types of pressure sensors to obtain an internal pressure measurement (para. [0047]).
Regarding claim 17, modified Glover discloses the fluid management system of claim 16.
However, modified Glover does not explicitly disclose wherein the controller further comprises a transducer in communication with the first pressure sensor.
McCaffrey reaches an analogous fluid monitoring system, including a catheter and a pressure sensor (Fig. 3A, para. [0039]). McCaffrey further teaches a controller comprises a transducer in communication with the pressure sensor (para. [0047]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the controller taught by modified Glover to additionally include a transducer in communication with the first pressure sensor, as taught by McCaffrey. This is because McCaffrey teaches a transducer allows for certain types of pressure sensors to obtain an internal pressure measurement (para. [0047]).
Response to Arguments
Applicant’s arguments, see pages 9-12 of Remarks, filed 06/11/2026, with respect to the rejection(s) of claim(s) 1-20 under 35 USC 103 have been fully considered and are partially persuasive. Specifically, Applicant’s have amended the claims to further define the external position sensor. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Larson et al. (US 20160296160 A1), hereinafter referred to as Larson.
Applicant's arguments, filed 06/11/2026, in regards to the positioning of the sensors have been fully considered but they are not persuasive.
Applicants have argued on pages 10-12 of Remarks, filed 06/11/2026, that “Glover nor Mitchell discloses or suggests the order of sensors recited in the present claims … there is no particular order of sensors in Mitchell … the order of the sensors is critical … first pressure sensor being closest to the second end … provide a baseline pressure reference … fluid movement sensor … provide accurate readings and minimize potential disturbances … volume sensor … record a magnitude of change …”.
The Examiner respectfully disagrees. First, Applicants arguments are not commensurate in scope with the claimed invention. The claims currently do not recite what the sensors are configured to measure. Second, as recited above, Mitchell discloses a first pressure sensor being closest to the second end. Third, the specificity of the location of the fluid movement sensor is in relation to the insertable tip, not the first pressure sensor (Instant spec, pg. 16, lines 15-16). Fourth, the specificity of the location of the volume sensor is in regards to the catheter tube, not the other sensors (Instant spec, pg. 17, line 11).
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.
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/K.W.K./Examiner, Art Unit 3791
/JASON M SIMS/Supervisory Patent Examiner, Art Unit 3791
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