Patent Application 15734821 - IMPLANTABLE DEVICE FOR DETERMINING A FLUID

Title: IMPLANTABLE DEVICE FOR DETERMINING A FLUID VOLUME FLOW THROUGH A BLOOD VESSEL

Application Information

Invention Title: IMPLANTABLE DEVICE FOR DETERMINING A FLUID VOLUME FLOW THROUGH A BLOOD VESSEL
Application Number: 15734821
Submission Date: 2025-05-23T00:00:00.000Z
Effective Filing Date: 2020-12-03T00:00:00.000Z
Filing Date: 2021-07-19T00:00:00.000Z
National Class: 600
National Sub-Class: 016000
Examiner Employee Number: 98259
Art Unit: 3796
Tech Center: 3700

Rejection Summary

102 Rejections: 0
103 Rejections: 8

Cited Patents

The following patents were cited in the rejection:

Office Action Text

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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 9/23/2024 has been entered.
Response to Arguments
Applicant’s arguments on Pg. 6-7 of Applicant’s Remarks filed 9/23/2024 (“Applicant’s Remarks”) regarding the rejection of Independent Claim 16 under 35 U.S.C. 102 as being anticipated by U.S. Patent No. 5,289,821 A to Swartz (“Swartz”) have been fully considered and are persuasive. Independent Claim 16 has been amended to affirmatively recite “a vessel wall port….” The Examiner agrees that Swartz does not disclose such a “vessel wall port” as is recited in amended Claim 16. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of WO 2017066257 A1 to Braido et al. (“Braido”) in view of EP 3378421 A1 to Kahlert et al. (“Kahlert”).
The Examiner notes as potentially relevant WO 1989006513 A1, which appears to teach a similar cuff to that of Claim 16.
Applicant’s arguments on Pg. 7-10 of Applicant’s Remarks regarding the rejection of Independent Claims 29 and 33 under 35 U.S.C. 103 have been fully considered and are persuasive for reasons similar to those explained above for Claim 16. Independent Claims 29 and 33 have also been amended to affirmatively recite “a vessel wall port.” In the Final Office Action dated 6/21/2024, Swartz is cited as teaching such a “vessel wall port” as previously recited. The Examiner agrees that the cited combination of references does not teach such a “vessel wall port” as is affirmatively recited by Claims 29 and 33 as amended. Therefore, the rejections have been withdrawn. However, upon further consideration, a new ground of rejection is made in view of WO 2017066257 A1 to Braido et al. (“Braido”) in view of EP 3378421 A1 to Kahlert et al. (“Kahlert”).
Applicant’s arguments regarding dependent Claims 17-23, 26-28, 30-32, and 34-35 have been fully considered and are persuasive. Applicant’s arguments are based on the dependency of Claims 17-23, 26-28, 30-32, and 34-35 upon the independent Claims from which they respectively depend. As explained above, the Examiner agrees with Applicant’s arguments regarding those respective independent Claims. Therefore, the rejections have been withdrawn. However, upon further consideration, a new ground of rejection is made in view of WO 2017066257 A1 to Braido et al. (“Braido”) in view of EP 3378421 A1 to Kahlert et al. (“Kahlert”).
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 16 and 26-28 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2017066257 A1 to Braido et al. (“Braido”)1 in view of EP 3378421 A1 to Kahlert et al. (“Kahlert”).
Regarding Independent Claim 16, Braido teaches:
A device for determining a blood volume flow through a blood vessel, comprising: (Para. [0009], “…a sensor implantation assembly for depositing a diagnostic sensor in a body of a patient is described. … A diagnostic sensor may also be included…”);
The preamble recitation “for determining a blood volume flow…” is being interpreted as a preamble statement reciting purpose or use. See MPEP 2111.02(II).
at least one sensor configured to detect at least one flow parameter of blood in the blood vessel, the blood vessel being in fluid communication with a pump of a cardiac assist system configured to be implanted in the blood vessel; (Figs. 12A and 12B, “sensor 800;” Para. [0070], “Sensors 200 may be used to measure and/or calculate one or more parameters including real time blood pressure, flow velocity (e.g., blood flow)….”);
“Sensor 800” is configured similarly to “sensors 200” (see Para. [0070], “Methods of using sensors 200 to measure aortic regurgitation or other body conditions are presented in the present disclosure with reference to FIGS. 6A through 15.”).
It is noted that only “at least one sensor” is affirmatively recited. The limitation “the blood vessel being in fluid communication with a pump of a cardiac assist system configured to be implanted in the blood vessel” limits the claim only in the sense that it requires the affirmatively recited sensor be capable of detecting at least one flow parameter of blood in such a vessel. Actual communication with such a pump is not required by the claim. Braido’s sensor is capable of such detecting.
a cuff configured to at least partially encircle an exterior wall of the blood vessel and retain the at least one sensor in or on the exterior wall; (Figs. 12A and 12B, “clip 801;” Para. [0100], “ FIGS. 12A-12B show an embodiment wherein a clip 801 or other external attachment device may be used to secure a sensor 800 to the exterior of an artery wall 340.”);
As shown in Fig. 12B, “arms 804” of “clip 801” “extend around the artery wall 340 to retain the sensor 800 in place” (see Para. [0070]).
wherein the cuff comprises at least one opening configured to receive the vessel wall port and retain the vessel wall port in a desired circumferential position in or on the exterior wall (Fig. 12B; see Annotated Fig. 12B, below).
It is noted that Braido does not teach such a “vessel wall port” as claimed. However, the limitation “at least one opening configured to receive the vessel wall port and retain the vessel wall port in a desired circumferential position in or on the exterior wall” imparts structural requirements to the recited “cuff” (rather than to the “vessel wall part”). The opening in Braido’s cuff (i.e., “clip 801”) is structurally capable of receiving a vessel wall port (e.g., receipt in the area between respective clip ends) and of retaining such a vessel wall port in place (e.g., in the same manner as sensor 800 is so-retained).

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Braido does not disclose:
and a vessel wall port coupled to the cuff, the vessel wall port shaped to penetrate the exterior wall of the blood vessel to receive a portion of the cardiac assist system therethrough,
Kahlert describes “an endovascular device arrangement (1) comprising a vascular access port (10); an endovascular device (20) for inserting into a patient's blood vessel through said vascular access port” (Abstract) in the context of cardiac catheter navigation (Para. [0004], which device “comprises a sensor” (Para. [0018]). Kahlert is analogous art.
Kahlert teaches:
and a vessel wall port coupled to the cuff, the vessel wall port shaped to penetrate the exterior wall of the blood vessel to receive a portion of the cardiac assist system therethrough, (Fig. 1, “vascular access port 10;” Para. [0029], “…the vascular access port 10 may provide access to the blood vessel 5 for an endovascular device 20, such as a catheter or a guide wire, which may be inserted into the blood vessel 5…”).
Kahlert’s “vascular access port 10” does in fact penetrate the exterior wall of the blood vessel, and thus is shaped in the manner claimed.
Kahlert’s “vascular access port 10” “provide access to the blood vessel 5 for an endovascular device 20, such as a catheter….” A catheter is such a portion of a cardiac assist system as claimed (e.g., such a percutaneous LVAD as the Present Specification states the invention is used with at Pg. 1, Ln. 7-11). Kahlert’s “vascular access port 10” is thus “shaped … to receive a portion of the cardiac assist system therethrough” as claimed.
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Braido with the teachings of Kahlert (i.e., to position Kahlert’s “vascular access port 10” within the opening shown in Annotated Fig. 12B of Braido’s “clip 801,” thereby “coupling” Kahlert’s “vascular access port 10” to Braido’s “clip 801” via such a “pressure fit” as described at Braido’s Para. [0100]) in order to “provide access to the blood vessel 5 for an endovascular device 20, such as a catheter or a guide wire, which may be inserted into the blood vessel 5 by a clinician through a channel 13 in the vascular access port 10, upon which the clinician may manipulate the endovascular device 20, e.g. push in, pull-out and/or twist (torque) …, in order to move the endovascular device 20 into a desired location within the patient's body, e.g. the patient's heart.” (Kahlert at Para. [0029]).
Regarding Claim 26, the combination of Braido and Kahlert renders obvious the entirety of Claim 16 as explained above.
Braido additionally teaches:
wherein the cuff is configured to position the vessel wall port to receive the portion of the cardiac assist system (Fig. 12B, “clip 801;” see Annotated Fig. 12B, above).
The limitation “configured to position the vessel wall port to receive the portion of the cardiac assist system” imparts structure to the claim only in the sense that the recited “cuff” is required to be structurally capable of positioning the vessel wall port in a particular manner. No details regarding the particular position are recited. Braido’s “clip 801,” and in particular the opening of Braido’s “clip 801” shown in Annotated Fig. 12B, position whatever is within the opening by virtue of the opening being situated in a distinct location. Braido’s “clip 801” is thus configured in the manner claimed.
Regarding Claim 27, the combination of Braido and Kahlert renders obvious the entirety of Claim 16 as explained above.
Kahlert additionally teaches:
wherein the vessel wall port comprises a feed-through for a cable of the cardiac assist system (Para. [0033], “The transmission stage 150 is driven by input power 152, which input power may be received from a user console coupled to the vascular access port 10, e.g. via one or more wires in the connection cable 18.”).
The limitation “a feed-through for a cable…” is being interpreted to mean an opening through which a cable (e.g., an electrical cable) may be inserted (see, e.g., Present Specification at Pg. 9, Ln. 9-11).
The limitation “for a cable” is being interpreted as an intended use of the recited “feed-through.”
Kahlert’s “vascular access port 10” comprises such an opening as evidenced by Para. [0033], and thus “comprises” such a “feed-through” as claimed.
Regarding Claim 28, the combination of Braido and Kahlert renders obvious the entirety of Claim 16 as explained above.
Kahlert additionally teaches:
wherein the vessel wall port comprises an opening for a bypass line of the cardiac assist system (Para. [0033], “The transmission stage 150 is driven by input power 152, which input power may be received from a user console coupled to the vascular access port 10, e.g. via one or more wires in the connection cable 18;” Para. [0029], “…the vascular access port 10 may provide access to the blood vessel 5 for an endovascular device 20, such as a catheter or a guide wire, which may be inserted into the blood vessel 5…”).
The limitation “for a bypass line” is being interpreted as an intended use of the recited opening. Kahlert’s opening is structurally capable of accommodating such a bypass line as recited.
Claims 17-18 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2017066257 A1 to Braido et al. (“Braido”) in view of EP 3378421 A1 to Kahlert et al. (“Kahlert”) as applied to Claim 16 above, and further in view of previously cited U.S. Patent No. 5,289,821 A to Swartz (“Swartz”).
Regarding Claim 17, the combination of Braido and Kahlert renders obvious the entirety of Claim 16 as explained above.
The combination of Braido and Kahlert does not disclose:
wherein the at least one sensor comprises an ultrasonic element
Swartz describes “A method of employing ultrasonic Doppler monitoring of blood flow in a patient's blood vessel…” (Abstract). Swartz is analogous art.
Swartz teaches:
wherein the at least one sensor comprises an ultrasonic element (Col. 3, Ln. 17-26, “Secured to or within strip 2 in a manner to be described hereinafter is a transducer 4 which preferably is in the high frequency range of about 20 MHz and may be generally cylindrical, having a diameter of about 1.00 mm. A wire 6, which is preferably a silver wire which is silicone encased, connects the transducer with ultrasonic processing means 10 which serves both to energize the crystal 4 to emit an ultrasonic pulse and to receive the echo pulse and process the same.”).
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of combined Braido and Kahlert with the teachings of Swartz (i.e., to use as Braido’s sensor such an ultrasonic sensor as taught by Swartz) in order to provide “an improved means for monitoring blood flow within a patient” (Swartz at Col. 2, Ln. 1-3).
Regarding Claim 18, the combination of Braido and Kahlert renders obvious the entirety of Claim 16 as explained above.
The combination of Braido and Kahlert does not disclose:
wherein the at least one sensor is configured to perform a pulsed Doppler measurement
Swartz describes “A method of employing ultrasonic Doppler monitoring of blood flow in a patient's blood vessel…” (Abstract). Swartz is analogous art.
Swartz teaches:
wherein the at least one sensor is configured to perform a pulsed Doppler measurement (Col. 2, Ln. 7-12, “The present method of ultrasonic Doppler monitoring of blood flow in a patient's blood vessel includes employing ultrasonic processing means which are adapted to both provide pulsed energy to the transducer and receive returned signals from the transducer and process the same.”).
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of combined Braido and Kahlert with the teachings of Swartz (i.e., to use as Braido’s sensor such an ultrasonic sensor which makes pulsed Doppler measurements as taught by Swartz) in order to provide “an improved means for monitoring blood flow within a patient” (Swartz at Col. 2, Ln. 1-3).
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over WO 2017066257 A1 to Braido et al. (“Braido”) in view of EP 3378421 A1 to Kahlert et al. (“Kahlert”) as applied to Claim 16 above, and further in view of previously cited U.S. Patent No. 5,289,821 A to Swartz (“Swartz”) as evidenced by previously cited Non-Patent Literature A. Vieli, "Doppler Flow Determination," British Journal of Anaesthesia, Volume 60, Supplement 1, 1988, Pages 107S-112S (“Vieli”).
Regarding Claim 19, the combination of Braido and Kahlert renders obvious the entirety of Claim 16 as explained above.
The combination of Braido and Kahlert does not disclose:
wherein the at least one sensor is configured to record a blood vessel cross-section of the blood vessel
Swartz describes “A method of employing ultrasonic Doppler monitoring of blood flow in a patient's blood vessel…” (Abstract). Swartz is analogous art.
Swartz teaches:
wherein the at least one sensor is configured to record a blood vessel cross-section of the blood vessel (Col. 2, Ln. 7-12, “The present method of ultrasonic Doppler monitoring of blood flow in a patient's blood vessel includes employing ultrasonic processing means which are adapted to both provide pulsed energy to the transducer and receive returned signals from the transducer and process the same.”).
Swartz’s ultrasonic processing means implicitly discloses recording a blood vessel cross-section of the blood vessel. The area of such a cross-section is a required piece of information for performing Doppler ultrasound measurements of flow rate (see Non-Patent Literature A. Vieli, "Doppler Flow Determination," British Journal of Anaesthesia, Volume 60, Supplement 1, 1988, Pages 107S-112S, Pg. 109S, Left Column, Third Paragraph, “…three quantities must be measured for the calculation of flow rate, namely the angle of incidence, the cross-sectional area of the vessel, and the mean transluminal blood flow velocity.”). In order to make a determination based on a required piece of information, that required piece of information must somehow be recorded (even if only transiently). Swartz’s ultrasonic processing means implicitly discloses recording a blood vessel cross-section of the blood vessel when the term is afforded its broadest reasonable interpretation.
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of combined Braido and Kahlert with the teachings of Swartz (i.e., to use as Braido’s sensor such an ultrasonic sensor which makes pulsed Doppler measurements as taught by Swartz, thereby causing the sensor to be configured to record a blood vessel cross-section of the blood vessel) in order to provide “an improved means for monitoring blood flow within a patient” (Swartz at Col. 2, Ln. 1-3).
Claims 20 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2017066257 A1 to Braido et al. (“Braido”) in view of EP 3378421 A1 to Kahlert et al. (“Kahlert”) as applied to Claim 16 above, and further in view of previously cited U.S. Patent No. 6,053,873 A to Govari et al. (“Govari”).
Regarding Claim 20, the combination of Braido and Kahlert renders obvious the entirety of Claim 16 as explained above.
The combination of Braido and Kahlert does not disclose:
wherein the at least one sensor comprises two ultrasonic elements
Govari describes “Implantable apparatus for measuring a fluid flow in the body of a subject, including a stent, having a generally cylindrical radial outer wall and a central lumen. A flow parameter sensor is fixed to the stent, and measures a parameter relating to a rate of blood flow through the stent,” (Abstract). Govari is thus analogous art.
Govari teaches:
wherein the at least one sensor comprises two ultrasonic elements (Col. 16, Lns. 3-14, “In one preferred embodiment of the present invention, circuitry 110 and transducers 112 and 114 function as a transit-time flow meter. Circuitry 110 drives downstream transducer 112 to emit ultrasonic waves into lumen 34. These waves are received by upstream transducer 114, after an upstream transit time dependent on the (fixed) distance between the two transducers and the velocity of blood flow through the lumen. Similarly, transducer 114 is driven to emit and transducer 112 receives, after a downstream transit time, ultrasonic waves. The difference between the longer upstream and the shorter downstream transit times is indicative of the blood flow velocity in lumen 34.”).
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of combined Braido and Kahlert with the teachings of Govari (i.e., to modify the device of combined Braido and Kahlert such that Braido’s sensors include two ultrasonic transducers as taught by Govari) in order to facilitate determination of blood flow velocity (Govari at Col. 16, Lns. 3-14).
Regarding Claim 21, the combination of Braido, Kahlert and Govari renders obvious the entirety of Claim 20 as explained above.
Govari additionally discloses:
wherein the two ultrasonic elements are offset relative to one another in a flow direction of the blood in the blood vessel (Col. 16, Lns. 3-14, “In one preferred embodiment of the present invention, circuitry 110 and transducers 112 and 114 function as a transit-time flow meter. Circuitry 110 drives downstream transducer 112 to emit ultrasonic waves into lumen 34. These waves are received by upstream transducer 114, after an upstream transit time dependent on the (fixed) distance between the two transducers and the velocity of blood flow through the lumen. Similarly, transducer 114 is driven to emit and transducer 112 receives, after a downstream transit time, ultrasonic waves. The difference between the longer upstream and the shorter downstream transit times is indicative of the blood flow velocity in lumen 34.”).
Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over WO 2017066257 A1 to Braido et al. (“Braido”) in view of EP 3378421 A1 to Kahlert et al. (“Kahlert”) and previously cited U.S. Patent No. 6,053,873 A to Govari et al. (“Govari”) as applied to Claim 20 above, and further in view of previously cited US 2013/0116575 A1 to Mickle et al. (“Mickle”).
Regarding Claim 22, the combination of Braido, Kahlert and Govari renders obvious the entirety of Claim 20 as explained above.
The combination of Braido, Kahlert and Govari does not disclose:
wherein the two ultrasonic elements are arranged opposite each other and aligned facing each other.
Mickle describes “…a method and device for detecting blood flow using an implantable wireless Doppler blood flow monitor.” (Para. [0001]). Mickle is thus analogous art.
Mickle discloses:
wherein the two ultrasonic elements are arranged opposite each other and aligned facing each other (Para. [0053], “FIGS. 2A and 2B are each a schematic representation of a cross-section of a sensor cuff 22 or 22' according to the invention. Sensor cuff 22 comprises a first transducer 24 for generating a signal through medium such as blood in a vessel. A second transducer 26 is positioned approximately 180.degree. opposite transducer 24 to receive the signal, at a shift commensurate with Doppler shift theory.”)
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of combined Braido, Kahlert and Govari with the teachings of Mickle (i.e., to position the ultrasonic elements opposite each other and facing one another) in order to minimize size of the device (Mickle at Para. [0058], “…the sensor cuff may comprise magnesium, possibly alloyed, with a single transducer or two transducers attached facing each other, which can result in a minimal diameter compared to the prior art.”).
Claim 23 is rejected under 35 U.S.C. 103 as being unpatentable over WO 2017066257 A1 to Braido et al. (“Braido”) in view of EP 3378421 A1 to Kahlert et al. (“Kahlert”) as applied to Claim 16 above, and further in view of previously cited U.S. Patent Publication No. 2001/0016686 A1 to Okada (“Okada”).
Regarding Claim 23, the combination of Braido and Kahlert renders obvious the entirety of Claim 16 as explained above.
The combination of Braido and Kahlert does not disclose:
wherein the sensor is configured to change a main beam direction of the sensor.
Okada describes “an ultrasonic diagnostic apparatus, and in particular to an apparatus for measuring blood vessel diameter, blood flow velocity, or the like,” (Para. [0002]), which diagnostic apparatus is “used for diagnosing blood vessel condition, heart functionality, and the like” (Para. [0004]). Okada is thus analogous art.
Okada discloses:
wherein the sensor is configured to change a main beam direction of the sensor. (Para. [0077], “Desirably, the transmitter-receiver includes an array transducer comprising a plurality of ultrasonic transducer elements, and the array transducer carries out transmission and reception of an ultrasonic beam in the first direction and that in the second direction in a time sharing manner. In such a case, first and second beams are desirably transmitted and received via parts on the array transducer. Desirably, the direction of a second beam is dynamically corrected following a change, if occurs, of the position of a sample gate.”).
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of combined Braido and Kahlert with the teachings of Okada (i.e., to modify the sensor of Braido such that it is configured to change a main beam direction) in order to “enable[] acquisition of data for use in evaluation value calculation, under angular condition appropriate for both displacement measurement and Doppler measurement (blood velocity measurement)” (Okada at Para. [0076]).
Claims 29-32 are rejected under 35 U.S.C. 103 as being unpatentable over previously cited U.S. Patent Publication No. 2010/0197994 A1 to Mehmanesh (“Mehmanesh”) in view of WO 2017066257 A1 to Braido et al. (“Braido”) and EP 3378421 A1 to Kahlert et al. (“Kahlert”).
Regarding Independent Claim 29, Mehmanesh teaches:
A system comprising: (Abstract, “A cardiac assist device (100) comprises a stent 103, 403) which is implantable into a blood vessel of a patient. … The cardiac assist device (100) further comprises a fluid supply adapted for periodically inflating and deflating the at least one inflatable element (104, 409-413)....”);
a cardiac assist system configured to be implanted within a blood vessel; (Para. [0014], “The cardiac assist device can be implanted in a blood vessel of the patient such as, for example, into the aorta or pulmonary artery.”);
and a device configured to determine blood volume flow of blood within the blood vessel, (Paras. [0054] – [0055], “The cardiac assist device 100 may further comprise a heartbeat detector 106. … The heartbeat detector can be configured to detect a cardiac action of the patient wearing the cardiac assist device. In some embodiments, the heartbeat detector 106 may comprise a flow sensor adapted to detect a flow speed of blood in the vicinity of the heartbeat detector.);
the device comprising: at least one sensor configured to detect at least one flow parameter of the blood in the blood vessel; (Para. [0055], “The heartbeat detector can be configured to detect a cardiac action of the patient wearing the cardiac assist device. In some embodiments, the heartbeat detector 106 may comprise a flow sensor adapted to detect a flow speed of blood in the vicinity of the heartbeat detector.);
Mehmanesh does not disclose:
a cuff configured to at least partially encircle an exterior wall of the blood vessel and retain the at least one sensor in or on the exterior wall; and a vessel wall port coupled to the cuff, the vessel wall port shaped to penetrate the exterior wall of the blood vessel to receive a portion of the cardiac assist system therethrough, wherein the cuff comprises at least one opening configured to receive the vessel wall port and retain the vessel wall port in a desired circumferential position in or on the exterior wall.
Braido describes “Vascular sensor implantation devices and methods” (Title) in the context of intravascular surgical procedures (Para. [0003]). Braido is analogous art.
Braido teaches:
a cuff configured to at least partially encircle an exterior wall of the blood vessel and retain the at least one sensor in or on the exterior wall; (Figs. 12A and 12B, “clip 801;” Para. [0100], “ FIGS. 12A-12B show an embodiment wherein a clip 801 or other external attachment device may be used to secure a sensor 800 to the exterior of an artery wall 340.”);
As shown in Fig. 12B, “arms 804” of “clip 801” “extend around the artery wall 340 to retain the sensor 800 in place” (see Para. [0070])
wherein the cuff comprises at least one opening configured to receive the vessel wall port and retain the vessel wall port in a desired circumferential position in or on the exterior wall (Fig. 12B; see Annotated Fig. 12B, above).
It is noted that Braido does not teach such a “vessel wall port” as claimed. However, the limitation “at least one opening configured to receive the vessel wall port and retain the vessel wall port in a desired circumferential position in or on the exterior wall” imparts structural requirements to the recited “cuff” (rather than to the “vessel wall part”). The opening in Braido’s cuff (i.e., “clip 801”) is structurally capable of receiving a vessel wall port (e.g., receipt in the area between respective clip ends) and of retaining such a vessel wall port in place (e.g., in the same manner as sensor 800 is so-retained).
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Mehmanesh with the teachings of Braido (i.e., to modify the cardiac assist system of Mehmanash so that it is used in conjunction with such a cuff system as taught by Braido) in order to overcome the difficulty associated with precisely securing a sensor in place in the artery (Braido at Para. [0005]).
The combination of Mehmanesh and Braido does not disclose:
and a vessel wall port coupled to the cuff, the vessel wall port shaped to penetrate the exterior wall of the blood vessel to receive a portion of the cardiac assist system therethrough,
Kahlert describes “an endovascular device arrangement (1) comprising a vascular access port (10); an endovascular device (20) for inserting into a patient's blood vessel through said vascular access port” (Abstract) in the context of cardiac catheter navigation (Para. [0004], which device “comprises a sensor” (Para. [0018]). Kahlert is analogous art.
Kahlert teaches:
and a vessel wall port coupled to the cuff, the vessel wall port shaped to penetrate the exterior wall of the blood vessel to receive a portion of the cardiac assist system therethrough, (Fig. 1, “vascular access port 10;” Para. [0029], “…the vascular access port 10 may provide access to the blood vessel 5 for an endovascular device 20, such as a catheter or a guide wire, which may be inserted into the blood vessel 5…”).
Kahlert’s “vascular access port 10” does in fact penetrate the exterior wall of the blood vessel, and thus is shaped in the manner claimed.
Kahlert’s “vascular access port 10” “provide access to the blood vessel 5 for an endovascular device 20, such as a catheter….” A catheter is such a portion of a cardiac assist system as claimed (e.g., such a percutaneous LVAD as the Present Specification states the invention is used with at Pg. 1, Ln. 7-11). Kahlert’s “vascular access port 10” is thus “shaped … to receive a portion of the cardiac assist system therethrough” as claimed.
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of combined Mehmanesh and Braido with the teachings of Kahlert (i.e., to position Kahlert’s “vascular access port 10” within the opening shown in Annotated Fig. 12B of Braido’s “clip 801,” thereby “coupling” Kahlert’s “vascular access port 10” to Braido’s “clip 801” via such a “pressure fit” as described at Braido’s Para. [0100]) in order to “provide access to the blood vessel 5 for an endovascular device 20, such as a catheter or a guide wire, which may be inserted into the blood vessel 5 by a clinician through a channel 13 in the vascular access port 10, upon which the clinician may manipulate the endovascular device 20, e.g. push in, pull-out and/or twist (torque) …, in order to move the endovascular device 20 into a desired location within the patient's body, e.g. the patient's heart.” (Kahlert at Para. [0029]).
Regarding Claim 30, the combination of Mehmanesh, Braido and Kahlert renders obvious the entirety of Claim 29 as explained above.
Braido additionally teaches:
wherein the cuff is configured to position the vessel wall port to receive the portion of the cardiac assist system (Fig. 12B, “clip 801;” see Annotated Fig. 12B, above).
This limitation is being interpreted similarly to similar Claim 26 above, the explanation of which applies equally here.
Regarding Claim 31, the combination of Mehmanesh, Braido and Kahlert renders obvious the entirety of Claim 29 as explained above.
Kahlert additionally teaches:
wherein the vessel wall port comprises a feed-through for a cable of the cardiac assist system( Para. [0033], “The transmission stage 150 is driven by input power 152, which input power may be received from a user console coupled to the vascular access port 10, e.g. via one or more wires in the connection cable 18.”).
This limitation is being interpreted similarly to similar Claim 27 above, the explanation of which applies equally here.
Regarding Claim 32, the combination of Mehmanesh, Braido and Kahlert renders obvious the entirety of Claim 29 as explained above.
Kahlert additionally teaches:
wherein the vessel wall port comprises an opening for a bypass line of the cardiac assist system. (Para. [0033], “The transmission stage 150 is driven by input power 152, which input power may be received from a user console coupled to the vascular access port 10, e.g. via one or more wires in the connection cable 18;” Para. [0029], “…the vascular access port 10 may provide access to the blood vessel 5 for an endovascular device 20, such as a catheter or a guide wire, which may be inserted into the blood vessel 5…”).
This limitation is being interpreted similarly to similar Claim 28 above, the explanation of which applies equally here.
Claims 33-35 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2017066257 A1 to Braido et al. (“Braido”) in view of EP 3378421 A1 to Kahlert et al. (“Kahlert”) and previously cited Non-Patent Literature C.A.D. Leguy, E.M.H. Bosboom, A.P.G. Hoeks, F.N. van de Vosse, Assessment of blood volume flow in slightly curved arteries from a single velocity profile, Journal of Biomechanics, Volume 42, Issue 11, 2009, Pages 1664-1672, (Year: 2009) (“Leguy”).
Regarding Independent Claim 33, Braido teaches:
A method for determining a blood volume flow through a blood vessel having a cardiac assist system configured to be implanted therein, the method comprising: (Abstract, “A sensor implantation assembly is disclosed…. The diagnostic sensor may be placed within a tissue wall to gather diagnostic information.”);
performing a measurement with at least one sensor of a device, the device comprising; (Abstract, “A sensor implantation assembly is disclosed…. The diagnostic sensor may be placed within a tissue wall to gather diagnostic information.”);
a cuff configured to at least partially encircle an exterior wall of the blood vessel and retain the at least one sensor in or on the exterior wall; (Figs. 12A and 12B, “clip 801;” Para. [0100], “ FIGS. 12A-12B show an embodiment wherein a clip 801 or other external attachment device may be used to secure a sensor 800 to the exterior of an artery wall 340.”);
As shown in Fig. 12B, “arms 804” of “clip 801” “extend around the artery wall 340 to retain the sensor 800 in place” (see Para. [0070])
wherein the cuff comprises at least one opening configured to receive the vessel wall port and retain the vessel wall port in a desired circumferential position in or on the exterior wall; (Fig. 12B; see Annotated Fig. 12B, above).
It is noted that Braido does not teach such a “vessel wall port” as claimed. However, the limitation “at least one opening configured to receive the vessel wall port and retain the vessel wall port in a desired circumferential position in or on the exterior wall” imparts structural requirements to the recited “cuff” (rather than to the “vessel wall part”). The opening in Braido’s cuff (i.e., “clip 801”) is structurally capable of receiving a vessel wall port (e.g., receipt in the area between respective clip ends) and of retaining such a vessel wall port in place (e.g., in the same manner as sensor 800 is so-retained).
Braido does not disclose:
and a vessel wall port coupled to the cuff, the vessel wall port shaped to penetrate the exterior wall of the blood vessel to receive a portion of the cardiac assist system therethrough,
and determining the blood volume flow based at least in part on the measurement.
Kahlert describes “an endovascular device arrangement (1) comprising a vascular access port (10); an endovascular device (20) for inserting into a patient's blood vessel through said vascular access port” (Abstract) in the context of cardiac catheter navigation (Para. [0004], which device “comprises a sensor” (Para. [0018]). Kahlert is analogous art.
Kahlert teaches:
and a vessel wall port coupled to the cuff, the vessel wall port shaped to penetrate the exterior wall of the blood vessel to receive a portion of the cardiac assist system therethrough, (Fig. 1, “vascular access port 10;” Para. [0029], “…the vascular access port 10 may provide access to the blood vessel 5 for an endovascular device 20, such as a catheter or a guide wire, which may be inserted into the blood vessel 5…”).
Kahlert’s “vascular access port 10” does in fact penetrate the exterior wall of the blood vessel, and thus is shaped in the manner claimed.
Kahlert’s “vascular access port 10” “provide access to the blood vessel 5 for an endovascular device 20, such as a catheter….” A catheter is such a portion of a cardiac assist system as claimed (e.g., such a percutaneous LVAD as the Present Specification states the invention is used with at Pg. 1, Ln. 7-11). Kahlert’s “vascular access port 10” is thus “shaped … to receive a portion of the cardiac assist system therethrough” as claimed.
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of combined Mehmanesh and Braido with the teachings of Kahlert (i.e., to position Kahlert’s “vascular access port 10” within the opening shown in Annotated Fig. 12B of Braido’s “clip 801,” thereby “coupling” Kahlert’s “vascular access port 10” to Braido’s “clip 801” via such a “pressure fit” as described at Braido’s Para. [0100]) in order to “provide access to the blood vessel 5 for an endovascular device 20, such as a catheter or a guide wire, which may be inserted into the blood vessel 5 by a clinician through a channel 13 in the vascular access port 10, upon which the clinician may manipulate the endovascular device 20, e.g. push in, pull-out and/or twist (torque) …, in order to move the endovascular device 20 into a desired location within the patient's body, e.g. the patient's heart.” (Kahlert at Para. [0029]).
The combination of Braido and Kahlert does not disclose:
and determining the blood volume flow based at least in part on the measurement.
Leguy describes “Assessment of blood volume flow in slightly curved arteries from a single velocity profile.” Leguy is thus analogous art.
Leguy discloses:
and determining the blood volume flow based at least in part on the measurement (Abstract, “Computational fluid dynamics simulations were used to compute the influence of curvature on velocity profiles. The BVF was then estimated from the simulation results with the CTM and methods based on Poiseuille, Womersley and using the center stream velocity and the velocity waveform at the position where the maximum velocity is observed, and compared to the prescribed BVF.”).
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the method disclosed by combined Braido and Kahlert with the teachings of Leguy (i.e., to determine blood volume flow in the manner describe by Leguy) in order to facilitate assessment of cardiac risk (Leguy at 1664, Left Column, First Paragraph).
Regarding Claim 34, the combination of Braido, Kahlert and Leguy renders obvious the entirety of Claim 33 as explained above.
Kahlert additionally teaches:
wherein the vessel wall port comprises a feed-through for a cable of the cardiac assist system( Para. [0033], “The transmission stage 150 is driven by input power 152, which input power may be received from a user console coupled to the vascular access port 10, e.g. via one or more wires in the connection cable 18.”).
This limitation is being interpreted similarly to similar Claim 27 above, the explanation of which applies equally here.
Regarding Claim 35, the combination of Braido, Kahlert and Leguy renders obvious the entirety of Claim 33 as explained above.
Kahlert additionally teaches:
wherein the vessel wall port comprises an opening for a bypass line of the cardiac assist system. (Para. [0033], “The transmission stage 150 is driven by input power 152, which input power may be received from a user console coupled to the vascular access port 10, e.g. via one or more wires in the connection cable 18;” Para. [0029], “…the vascular access port 10 may provide access to the blood vessel 5 for an endovascular device 20, such as a catheter or a guide wire, which may be inserted into the blood vessel 5…”).
This limitation is being interpreted similarly to similar Claim 28 above, the explanation of which applies equally here.

Conclusion
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/C.J.M./Examiner, Art Unit 3796

/LYNSEY C Eiseman/Primary Examiner, Art Unit 3796

1 WO 2017066257 A1 was disclosed by Applicant in the IDS dated 9/24/2021.