DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
Amendments entered 05/13/2026 have been entered. Amendments to the claims overcome the previous 101 rejection as well as the claim interpretation under 112(f). The 101 rejections have been withdrawn, and while the amendments remove the need for 112f interpretation for the detection unit, a 112f interpretation is still applied to the flow rate calculation unit as said language was introduced into claim 1.
Response to Arguments
Applicant's arguments filed 05/13/2026 have been fully considered but they are not persuasive.
Applicant argues that Utsugida as applied would not have been obvious to combine with Burke as such a combination would reduce or eliminate the patient’s ability to go about daily life unencumbered. The examiner finds said argument to be nonpersuasive as both arts are directed to cardiac/circulatory assisting devices and thus said combination would be obvious. Further, the examiner notes that Bolling as also combined with Burke and Utsugida, shows that circulatory assist device may have external components and thus the combination of Burke and Utsugida would have been obvious to one having ordinary skill in the art.
Applicant further argues that Burke recites that the right blood pump receives blood from the right ventricle and supplies blood to the patient’s pulmonary system, so no oxygenator is needed for the system of Burke. Thus, adding an oxygenator of Utsugida (per the new limitation of the instant application) would be redundant to the operation of the system of Burke. The examiner respectfully disagrees. While Burke’s second pump is connected to the pulmonary system, this does not exclude the combination of an oxygenator or artificial lung being used. Utsugida teaches that in use the system performs extracorporeal circulation with an artificial lung by operating the pump the draw blood from a patient’s vein, performing gas exchange in the blood using an artificial lung to oxygenate the blood, and then returning the oxygenated blood to the patient’s artery or vein, where said device “substitutes for the functions of the heart and lungs” (para. 0034 of Utsugida). The examiner notes that therefore an artificial or substitute for lungs can be readily combined with a substitute for the heart to circulate blood and oxygenate is when needed, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to provide the system of Burke with an artificial lung on the second pump circuit as a means to oxygenate the blood. The examiner notes that the second pump loop of Burke supplies blood to the pulmonary system and thus to the femoral artery, and as the oxygenated blood of Utsugida is said to be returned to the body in veins or arteries, said combination would still allow the second blood loop of Burke to function in the intended manner.
Applicant further argues that the system of the prior art operates in manner opposite from the claimed limitation. The instant application performs a calculation of maintaining a target flow rate of blood, in that the auxiliary flow rate = target flow rate – detected flow rate), and applicant argues that this differs from the prior art determination that blood flow rate is balanced between the two pumps (as flow through one is increased, the other is also increased). The examiner respectfully disagrees with the argument that Burke does not teach that auxiliary flow rate = target flow rate-detected flow rate. Per the previous rejection (of claim 2), the examiner cites paragraphs 0054-0058. Per said citations, blood flow is calculated through each of the pumps, where said calculation is done by sensed data (para. 0055). Per para. 0056 the system calculates a target flow rate and then compares the target to the calculated (sensor data) rate and adjusts the pump up or down to reach the target rate. Per para. 0057, rather than determining a target blood flow, the controller may compare blood flow through the pumps to determine is a predetermined range is satisfied, where the controller then adjusts the pump such that the relationship is achieved. The examiner notes that as that while not explicitly in the words as claimed, a target rate is compared to a sensed rate, where said difference is thus determined (interpreted as the auxiliary rate), and the controller then adjusts the pump based on said difference (auxiliary rate). As such, the prior art is interpreted to read to the claimed invention.
Claim Objections
Claim 1 objected to because of the following informalities: In the newly amended clause beginning with "wherein the first blood circulation device comprises" , the term based is misspelled as "base"
In the last line of the claim, auxiliary is misspelled as “auxiliar”. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 3,6 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.
The examiner notes that in claim 1, it was amended to include “wherein the second blood circulation device comprises an input section configured to receive a user input for a target flow rate of blood”. Claim 3 requires the system of claim 1, “further comprising a second input section in the second control section configured for a medical user to input the target flow rate for the patient”. Based on paragraph 0066 of the instant application, it appears that the second section only comprises a singe input section (150) for inputting a target flow rate. The examiner notes that while it is understood that both the first (para. 0037) and second section may have independent input sections (thus two total input sections), the second section itself does not have a second input section. As such it is interpreted that the input section of claim 3 is the same input section as claimed in claim 1.
The examiner notes that in claim 4, it was amended to include “wherein the first blood circulation device comprises an input section configured to receive a user input for a target flow rate of blood”. Claim 6 requires the system of claim 4, “further comprising a first input section in the first control section configured for a medical user to input the target flow rate for the patient”. This limitation is unclear as claim 4 is providing an input section in the first section so how can another input section be the first in the first section. Based on paragraph 0037 of the instant application, it appears that the first section only comprises a single input section (70) for inputting a target flow rate. The examiner notes that while it is understood that both the first and second (para. 0066) section may have independent input sections (thus two total input sections), the first section itself does not have a two input sections. As such it is interpreted that the input section of claim 6 is the same input section as claimed in claim 4.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
The calculation unit of claim 2-3,5-6 is interpreted under 112f. Per paragraph 0037 and 0065, the first control unit is a controller comprising the flow calculation unit, and the second control unit is a controller comprising the flow calculation unit, where both are controlled by a program. Therefore, it is interpreted that the calculation unit is a programmed controller.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claim(s) 1,3,4,6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Burke et al. EP 2618862 in view of Bolling et al. 2005/0085683 and further in view of Utsugida et al. WO 2020261688, and further in view of Botterbusch, where Botterbusch was applied in the previous office action, hereafter Burke, Bolling, Utsugida, and Botterbusch respectively.
Regarding claim 1, Burke discloses a blood circulation system (para. 0001) configured to remove blood from a living body of a patient and send the blood to the living body (para. 0010) the blood circulation system comprising: a first blood circulation device (figure 1, pump 16) a second blood circulation device (figure 1, pump 18); and a flow sensor (para. 0034, where sensor 36 measures flow through pump 16 and sensor 38 measures flow through pump 18); wherein the first blood circulation device is comprised of: a first blood removal vessel portion having a distal end inserted into a left ventricle of the living body via a subclavian artery of the living body (figure 1, para. 0025, where pump 16 receives blood from the left ventricle) a first blood sending vessel portion having a distal end inserted into an ascending aorta of the living body via the subclavian artery (para. 0025 where the pump sends blood to the patient’s vasculature, as seen in figure 1, the pump is connected to the aorta). The examiner notes that Burke does not disclose insertion through the subclavian artery for either portion. However, the examiner notes that this is an intended use of the device claim, not a method of insertion. PER MPEP Section 2114, [A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Therefore, as Burke teaches a first blood flow system connected to both the left ventricle and the aorta (As is the claimed device) where said device is at least inserted into said locations, and the specific insertion through the subclavian artery is functional language, it is interpreted that the device reads to the claimed invention.
Burke further discloses a first centrifugal pump (para. 0027), including a first inlet port and a first outlet port (the examiner notes that the portion of the pump receiving blood from the ventricle is the inlet and the portion of the pump for sending is the outlet) , wherein the first centrifugal pump removes blood from the left ventricle to the first inlet port (para. 0025), and wherein the first centrifugal pump sends blood from the first outlet port to the ascending aorta (para. 0025, figure 1); and a first control section that controls the first centrifugal pump ((para 0025, where the pumps are operated by independent control signals, where the signal controlling the second pump is the second control section)).
The examiner notes that however, the pump of Burke is not located outside the body.
Bolling teaches a heart circulation pumping system and is thus considered analogous to the claimed invention. Bolling teaches that the system comprises a pump (abstract) that may be a centrifugal pump (para. 0039) having an inlet and an outlet connected to it (para. 0039). As seen in figure 1-3 the pump is located within the body, whereas in figure 6-7 the pump is located externally. Per paragraph 0068, the pump and its associated driving means and controls are employed extracorporeally. Therefore, as Bolling teaches a heart circulation pump where the pump comprises an inlet and an outlet, and where the pump may be located internally or externally, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to provide both the first (16) and second (18) circulation pump of Burke with an inlet and outlet (for connecting to receiving and sending portions respectfully) and provided the pumps externally. Said combination involves some teaching, suggestion, or motivation in the prior art (circulation pumps may be internal or external) that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings (modify the pump of Burke to be external as said location is an known location in which said pumps can function) to arrive at the claimed invention, and thus a prima facie case of obviousness exists. The examiner notes that per the combination the first blood removal vessel portion is interpreted to be the connection between the inlet port and the left ventricle and via the first blood sending vessel portion is interpreted to be the connection between the outlet port and the aorta. The examiner further notes that per the combination the second blood removal vessel portion is interpreted to be the connection between the inlet port and the right ventricle and the second blood sending vessel portion is interpreted to be the connection between the outlet port and the connection to the pulmonary system.
The examiner notes that Burke discloses wherein the second blood circulation device is comprised of: a second blood removal vessel portion having a distal end (para. 0025 where the second device comprises the pump (18) with a receiving end in the right ventricle); a second blood sending vessel portion having a distal end (para. 0025 where the second device comprises the pump (18) with a sending end for sending to the pulmonary system); a second centrifugal pump that is disposed outside the living body (per the obvious combination in view of Bolling the second pump is also external), including a second inlet port and a second outlet port, wherein the second centrifugal pump removes blood to the second inlet port via the second blood removal vessel portion (see obviousness statement in view of Bolling above, also para. 0025), and wherein the second centrifugal pump sends blood from the second outlet port via the second blood sending vessel portion (see obviousness statement in view of Bolling above, also para. 0025), the second inlet port being connected to a proximal end of the second blood removal vessel portion, the second outlet port being connected to a proximal end of the second blood sending vessel portion. Per the combination the second blood removal vessel portion is interpreted to be the connection between the inlet port and the right ventricle and the second blood sending vessel portion is interpreted to be the connection between the outlet port and the connection to the pulmonary system.; and a second control section that controls the second centrifugal pump (para 0025, where the pumps are operated by independent control signals, where the signal controlling the second pump is the second control section). Further per para. 0029, the controller can be distributed among several different devices.
The examiner notes that while the defined second circulation device would reasonably connect to the femoral artery (through the pulmonary system) and the femoral vein (through the right ventricle) (as deoxygenated blood flows from the femoral vein to the right atrium and then the right ventricle, and further flows from the right ventricle to the pulmonary system ([lungs] and then through the femoral artery, there is no specific disclosure that the inlet and outlet are directing inserted into the femoral vein/artery. The examiner does note that said insertion into the femoral vein/artery is a statement of intended use. As such the device of Burke would reasonably function if placed in the same locations as claimed as the circulation pathway is the same. However, for clarity the examiner further relies on Utsugida.
Utsugida teaches a circulation device and is thus considered analogous to the claimed invention. Utsugida teaches that the circulation system comprises a blood removal side inserted into the femoral vein (para. 0036) and a blood sending side inserted into the femoral artery (para. 0037). The device of Utsugida further comprises a centrifugal pump (para. 0035) for said circulation. Therefore, as Utsugida teaches a blood circulation system using a centrifugal pump, where the inlet and outlet are located at the femoral vein and artery respectively, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to provide the second circulation device of Burke at the located as claimed by Utsugida. Doing so would merely involve applying a known technique (inflow and outflow at a femoral vein and artery) to a known device (blood circulation device) ready for improvement to yield predictable results (that being the circulation blood through the femoral vein/artery);
With new amended limitation (per 05/13/26) regarding to the limitation that the first control section, second control section, and the blood flow rate sensor are configured to be disposed outside the body, the examiner notes that per the combination of Burke with Bolling, the pump as well as conduits may be located outside the body. As the sensors within the flow pathway where said flow pathway extends both internally and externally, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention, via rearrangement of parts (See MPEP Section 2144.04 VI C), to have the sensors within the external portion of the conduit. Doing so would not have impeded the detection function as the sensor is still exposed to flowing blood. Further, per paragraph 0068 of Bolling, the pump, driving means, and control means are extracorporeal and thus upon the combination above under the same rejection, the control sections would be located outside the body. Per paragraph 0034 of Burke, the controller receives flow data from the sensors. Per para. 0054-0058, the controller operates by at least calculating blood flow through the pumps, measures input from the flow sensors, determines the average or instant flow, and sets the speed of the pumps based on the flow. The controller may also compare flow between the two pumping systems and determine if the relationship between the flows is suitable. Therefore, the controller may control the first pump based on a result (value) of the second detection unit via the comparison of the two sensors.
The examiner notes that per the claim amendments filed 05/13/26, new limitations were introduced. Said limitations include an oxygenator configured to be disposed outside the living body and oxygenate blood flowing through, an input section in the second circulation device for receiving a user input and where the first blood circulation device comprises a flow rate calculation unit configured to calculate an auxiliary flow rate of blood targeted to flow into the first blood sending vessel portion based on the auxiliary flow rate equaling the target flow rate minus the detected flow rate from the blood flow rate sensor.
Regarding the oxygenator, Utsugida teaches that in use the system performs extracorporeal circulation with an artificial lung by operating the pump the draw blood from a patient’s vein, performing gas exchange in the blood using an artificial lung to oxygenate the blood, and then returning the oxygenated blood to the patient’s artery or vein, where said device “substitutes for the functions of the heart and lungs” (para. 0034 of Utsugida). The examiner notes that therefore an artificial or substitute for lungs can be readily combined with a substitute for the heart to circulate blood and oxygenate is when needed, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to provide the system of Burke with an artificial lung on the second pump circuit as a means to oxygenate the blood. The examiner notes that the second pump loop of Burke supplies blood to the pulmonary system and thus to the femoral artery, and as the oxygenated blood of Utsugida is said to be returned to the body in veins or arteries, said combination would still allow the second blood loop of Burke to function in the intended manner.
Regarding the input section limitation, the examiner notes that per para. 0145 of Burke the system may comprise an input/output device for communicating signals to peripheral devices, where said devices may include instructions such as controlling operation of the pump. Para. 0006 and 0008 of Burke disclose the controller setting the pump speeds, and para. 0037 teaches that the clinician can input operating parameters for one or both pumps.
However no specific disclosure is made regarding an input section in the second control section configured for a user to input the target flow rate.
Botterbusch teaches a heart pumping system and is thus considered analogous to the claimed invention. Botterbusch teaches that the device comprises a controller (30) and a programmer (50), where said programmer “may be conventional laptop loaded with programmed software routines for configuring controller 30 and setting operational parameters that controller 30 uses to control operation of implantable pump 20” (para. 0056). Further, per para. 0056, the programmer is located in a clinician’s office and parameters set may include target flow rate. “When first implanted, the surgeon or clinician may use programmer 50 to communicate initial operating parameters to controller 30”. Therefore, it is interpreted that the clinician sets the target flow rate upon first use, and may make adjustments as detailed in para. 0056. Therefore, as Botterbusch teaches a programmer for allowing a clinician to set various parameters of pump operation within a circulation system, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to provide a clinician programmer for the device of Burke, as Burke discloses communication with outside devices and target setting for flow rate. Doing so would merely involve combining prior art elements (circulation pumping systems with a clinician input to the controller with a circulation pumping system with controller) according to known methods to yield predictable results (that being clinician setting of target values). The examiner notes that as Burke teaches that the parameters may be entered for one or both pumps, it is interpreted that said pump inputs may be input separately and thus each section (first and second) would have an input for their respective pumps.
Lastly, regarding the new limitation of “where the first blood circulation device comprises a flow rate calculation unit configured to calculate an auxiliary flow rate of blood targeted to flow into the first blood sending vessel portion based on the auxiliary flow rate equaling the target flow rate minus the detected flow rate from the blood flow rate sensor”, the examiner cites paragraphs of Burke 0054-0058 (previously cited under the rejection of claim 2). Per said citations, blood flow is calculated through each of the pumps, where said calculation is done by sensed data (para. 0055). Per para. 0056 the system calculates a target flow rate and then compares the target to the calculated (sensor data) rate and adjusts the pump up or down to reach the target rate. Per para. 0057, rather than determining a target blood flow, the controller may compare blood flow through the pumps to determine is a predetermined range is satisfied, where the controller then adjusts the pump such that the relationship is achieved. The examiner notes that as a target rate is compared to a sensed rate, where said difference is thus determined (interpreted as the auxiliary rate), and the controller then adjusts the pump based on said difference (auxiliary rate). As such, the prior art is interpreted to read to the claimed invention.
Regarding claim 3, Burke, Bolling, Utsugida, and Botterbusch teach the blood circulation system according to claim 2 comprising a second input section in the second control section configured for a medical user to unput the target flow rate for the patient to flow into the ascending aorta, as detailed under the rejection of claim 1.
Regarding claim 4 Burke discloses a blood circulation system (para. 0001) configured to remove blood from a living body of a patient and send the blood to the living body (para. 0010) the blood circulation system comprising: a first blood circulation device (figure 1, pump 16) a second blood circulation device (figure 1, pump 18); and a flow rate sensor (para. 0034, where sensor 36 measures flow through pump 16 and sensor 38 measures flow through pump 18); wherein the first blood circulation device is comprised of: a first blood removal vessel portion having a distal end inserted into a left ventricle of the living body via a subclavian artery of the living body (figure 1, para. 0025, where pump 16 receives blood from the left ventricle); a first blood sending vessel portion having a distal end inserted into an ascending aorta of the living body via the subclavian artery para. 0025 where the pump sends blood to the patient’s vasculature, as seen in figure 1, the pump is connected to the aorta) The examiner notes that Burke does not disclose insertion through the subclavian artery for either portion. However, the examiner notes that this is an intended use of the device claim, not a method of insertion. PER MPEP Section 2114, [A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Therefore, as Burke teaches a first blood flow system connected to both the left ventricle and the aorta (As is the claimed device) where said device is at least inserted into said locations, and the specific insertion through the subclavian artery is functional language, it is interpreted that the device reads to the claimed invention.
Burke further discloses a first centrifugal pump (para. 0027), including a first inlet port and a first outlet port (the examiner notes that the portion of the pump receiving blood from the ventricle is the inlet and the portion of the pump for sending is the outlet), wherein the first centrifugal pump removes blood from the left ventricle to the first inlet port (para. 0025), and wherein the first centrifugal pump sends blood from the first outlet port to the ascending aorta (para. 0025, figure 1); and a first control section that controls the first centrifugal pump ((para 0025, where the pumps are operated by independent control signals, where the signal controlling the second pump is the second control section)).
The examiner notes that however, the pumps of Burke are not located outside the body.
Bolling teaches a heart circulation pumping system and is thus considered analogous to the claimed invention. Bolling teaches that the system comprises a pump (abstract) that may be a centrifugal pump (para. 0039) having an inlet and an outlet connected to it (para. 0039). As seen in figure 1-3 the pump is located within the body, whereas in figure 6-7 the pump is located externally. Per paragraph 0068, the pump and its associated driving means and controls are employed extracorporeally. Therefore, as Bolling teaches a heart circulation pump where the pump comprises an inlet and an outlet, and where the pump may be located internally or externally, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to provide both the first (16) and second (18) circulation pump of Burke with an inlet and outlet (for connecting to receiving and sending portions respectfully) and provided the pumps externally. Said combination involves some teaching, suggestion, or motivation in the prior art (circulation pumps may be internal or external) that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings (modify the pump of Burke to be external as said location is an known location in which said pumps can function) to arrive at the claimed invention, and thus a prima facie case of obviousness exists. The examiner notes that per the combination the first blood removal vessel portion is interpreted to be the connection between the inlet port and the left ventricle and via the first blood sending vessel portion is interpreted to be the connection between the outlet port and the aorta. The examiner further notes that per the combination the second blood removal vessel portion is interpreted to be the connection between the inlet port and the right ventricle and the second blood sending vessel portion is interpreted to be the connection between the outlet port and the connection to the pulmonary system.
The examiner notes that Burke discloses wherein the second blood circulation device is comprised of: a second blood removal vessel portion having a distal end (para. 0025 where the second device comprises the pump (18) with a receiving end in the right ventricle); a second blood sending vessel portion having a distal end (para. 0025 where the second device comprises the pump (18) with a sending end for sending to the pulmonary system); a second centrifugal pump that is disposed outside the living body (per the obvious combination in view of Bolling the second pump is also external), including a second inlet port and a second outlet port, wherein the second centrifugal pump removes blood to the second inlet port via the second blood removal vessel portion (see obviousness statement in view of Bolling above, also para. 0025), and wherein the second centrifugal pump sends blood from the second outlet port via the second blood sending vessel portion (see obviousness statement in view of Bolling above, also para. 0025), the second inlet port being connected to a proximal end of the second blood removal vessel portion, the second outlet port being connected to a proximal end of the second blood sending vessel portion. Per the combination the second blood removal vessel portion is interpreted to be the connection between the inlet port and the right ventricle and the second blood sending vessel portion is interpreted to be the connection between the outlet port and the connection to the pulmonary system.; and a second control section that controls the second centrifugal pump (para 0025, where the pumps are operated by independent control signals, where the signal controlling the second pump is the second control section). Further per para. 0029, the controller can be distributed among several different devices.
The examiner notes that while the defined second circulation device would reasonably connect to the femoral artery (through the pulmonary system) and the femoral vein (through the right ventricle) (as deoxygenated blood flows from the femoral vein to the right atrium and then the right ventricle, and further flows from the right ventricle to the pulmonary system ([lungs] and then through the femoral artery, there is no specific disclosure that the inlet and outlet are directing inserted into the femoral vein/artery. The examiner does note that said insertion into the femoral vein/artery is a statement of intended use. As such the device of Burke would reasonably function if placed in the same locations as claimed as the circulation pathway is the same. However, for clarity the examiner further relies on Utsugida.
Utsugida teaches a circulation device and is thus considered analogous to the claimed invention. Utsugida teaches that the circulation system comprises a blood removal side inserted into the femoral vein (para. 0036) and a blood sending side inserted into the femoral artery (para. 0037). The device of Utsugida further comprises a centrifugal pump (para. 0035) for said circulation. Therefore, as Utsugida teaches a blood circulation system using a centrifugal pump, where the inlet and outlet are located at the femoral vein and artery respectively, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to provide the second circulation device of Burke at the located as claimed by Utsugida. Doing so would merely involve applying a known technique (inflow and outflow at a femoral vein and artery) to a known device (blood circulation device) ready for improvement to yield predictable results (that being the circulation blood through the femoral vein/artery);
With new amended limitation (per 05/13/26) regarding to the limitation that the first control section, second control section, and the blood flow rate sensor are configured to be disposed outside the body, the examiner notes that per the combination of Burke with Bolling, the pump as well as conduits may be located outside the body. As the sensors within the flow pathway where said flow pathway extends both internally and externally, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention, via rearrangement of parts (See MPEP Section 2144.04 VI C), to have the sensors within the external portion of the conduit. Doing so would not have impeded the detection function as the sensor is still exposed to flowing blood. Further, per paragraph 0068 of Bolling, the pump, driving means, and control means are extracorporeal and thus upon the combination above under the same rejection, the control sections would be located outside the body. Per paragraph 0034 of Burke, the controller receives flow data from the sensors. Per para. 0054-0058, the controller operates by at least calculating blood flow through the pumps, measures input from the flow sensors, determines the average or instant flow, and sets the speed of the pumps based on the flow. The controller may also compare flow between the two pumping systems and determine if the relationship between the flows is suitable. Therefore, the controller may control the first pump based on a result (value) of the second detection unit via the comparison of the two sensors.
The examiner notes that per the claim amendments filed 05/13/26, new limitations were introduced. Said limitations include an oxygenator configured to be disposed outside the living body and oxygenate blood flowing through, an input section in the second circulation device for receiving a user input and where the first blood circulation device comprises a flow rate calculation unit configured to calculate an auxiliary flow rate of blood targeted to flow into the first blood sending vessel portion based on the auxiliary flow rate equaling the target flow rate minus the detected flow rate from the blood flow rate sensor.
Regarding the oxygenator, Utsugida teaches that in use the system performs extracorporeal circulation with an artificial lung by operating the pump the draw blood from a patient’s vein, performing gas exchange in the blood using an artificial lung to oxygenate the blood, and then returning the oxygenated blood to the patient’s artery or vein, where said device “substitutes for the functions of the heart and lungs” (para. 0034 of Utsugida). The examiner notes that therefore an artificial or substitute for lungs can be readily combined with a substitute for the heart to circulate blood and oxygenate is when needed, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to provide the system of Burke with an artificial lung on the second pump circuit as a means to oxygenate the blood. The examiner notes that the second pump loop of Burke supplies blood to the pulmonary system and thus to the femoral artery, and as the oxygenated blood of Utsugida is said to be returned to the body in veins or arteries, said combination would still allow the second blood loop of Burke to function in the intended manner.
Regarding the input section limitation, the examiner notes that per para. 0145 of Burke the system may comprise an input/output device for communicating signals to peripheral devices, where said devices may include instructions such as controlling operation of the pump. Para. 0006 and 0008 of Burke disclose the controller setting the pump speeds, and para. 0037 teaches that the clinician can input operating parameters for one or both pumps.
However no specific disclosure is made regarding an input section in the first control section configured for a medical user to input the target flow rate for the patient to flow to the ascending aorta.
Botterbusch teaches a heart pumping system and is thus considered analogous to the claimed invention. Botterbusch teaches that the device comprises a controller (30) and a programmer (50), where said programmer “may be conventional laptop loaded with programmed software routines for configuring controller 30 and setting operational parameters that controller 30 uses to control operation of implantable pump 20” (para. 0056). Further, per para. 0056, the programmer is located in a clinician’s office and parameters set may include target flow rate. “When first implanted, the surgeon or clinician may use programmer 50 to communicate initial operating parameters to controller 30”. Therefore, it is interpreted that the clinician sets the target flow rate upon first use, and may make adjustments as detailed in para. 0056. Therefore, as Botterbusch teaches a programmer for allowing a clinician to set various parameters of pump operation within a circulation system, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to provide a clinician programmer for the device of Burke, as Burke discloses communication with outside devices and target setting for flow rate. Doing so would merely involve combining prior art elements (circulation pumping systems with a clinician input to the controller with a circulation pumping system with controller) according to known methods to yield predictable results (that being clinician setting of target values). The examiner notes that as Burke teaches that the parameters may be entered for one or both pumps, it is interpreted that said pump inputs may be input separately and thus each section (first and second) would have an input for their respective pumps.
Lastly, regarding the new limitation of “where the first blood circulation device comprises a flow rate calculation unit configured to calculate an auxiliary flow rate of blood targeted to flow into the first blood sending vessel portion based on the auxiliary flow rate equaling the target flow rate minus the detected flow rate from the blood flow rate sensor”, the examiner cites paragraphs of Burke 0054-0058 (previously cited under the rejection of claim 2). Per said citations, blood flow is calculated through each of the pumps, where said calculation is done by sensed data (para. 0055). Per para. 0056 the system calculates a target flow rate and then compares the target to the calculated (sensor data) rate and adjusts the pump up or down to reach the target rate. Per para. 0057, rather than determining a target blood flow, the controller may compare blood flow through the pumps to determine is a predetermined range is satisfied, where the controller then adjusts the pump such that the relationship is achieved. The examiner notes that as a target rate is compared to a sensed rate, where said difference is thus determined (interpreted as the auxiliary rate), and the controller then adjusts the pump based on said difference (auxiliary rate). As such, the prior art is interpreted to read to the claimed invention.
Regarding claim 6, Burke, Bolling, Utsugida, and Botterbusch teach the blood circulation system according to claim 4 comprising a second input section in the second control section configured for a medical user to unput the target flow rate for the patient to flow into the ascending aorta, as detailed under the rejection of claim 4.
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Burke in view of Utsugida.
Regarding claim 7 Burke discloses a method of circulating blood of a living body of a patient (para. 0001,0010) using a first blood circulation device (figure 1, pump 16), a second blood circulation device (figure 1, pump 18), and a detection unit (para. 0034, where sensor 36 measures flow through pump 16 and sensor 38 measures flow through pump 18), the method comprising the steps of: connecting the first blood circulation device to the patient so that a first centrifugal pump (para. 0027) removes blood from a left ventricle of the patient (para. 0025 where pump 16 receives blood from the left ventricle) and sends blood to an ascending aorta of the patient (para. 0025 where the pump sends blood to the patient’s vasculature, as seen in figure 1, the pump is connected to the aorta); connecting the second blood circulation device to the patient so that a second centrifugal pump (para. 0027) removes blood (para. 0025 where the second device comprises the pump (18) with a receiving end in the right ventricle) and sends blood (para. 0025 where the second device comprises the pump (18) with a sending end for sending to the pulmonary system).
The examiner notes that while the defined second circulation device would reasonably connect to the femoral artery (through the pulmonary system) and the femoral vein (through the right ventricle) (as deoxygenated blood flows from the femoral vein to the right atrium and then the right ventricle, and further flows from the right ventricle to the pulmonary system ([lungs] and then through the femoral artery, there is no specific disclosure that the inlet and outlet are, in a method step, inserted into the femoral vein/artery.
Utsugida teaches a circulation device and is thus considered analogous to the claimed invention. Utsugida teaches that the circulation system comprises a blood removal side inserted into the femoral vein (para. 0036) and a blood sending side inserted into the femoral artery (para. 0037). The device of Utsugida further comprises a centrifugal pump (para. 0035) for said circulation. Therefore, as Utsugida teaches a blood circulation system using a centrifugal pump, where the inlet and outlet are located at the femoral vein and artery respectively, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to provide the second circulation device of Burke at the located as claimed by Utsugida. Doing so would merely involve applying a known technique (inflow and outflow inserted at a femoral vein and artery ) to a known device (blood circulation device) ready for improvement to yield predictable results (that being the circulation blood through the femoral vein/artery). Therefore, the combination would include a step of attaching the second inflow and outflow to the femoral vein and artery.
Burke further discloses setting a target flow rate for the patient to flow to the ascending aorta (Per para. 0024, 0051,0056, where per 0051 the lead pump (16) has a target rate); detecting a main flow rate of blood flowing through one of the first blood circulation device or the second blood circulation device to generate a detection result (para. 0055 where the controller measures inputs from flow sensors); calculating an auxiliary flow rate of blood targeted to flow in the other one of the first blood circulation device or the second blood circulation device based on the target flow rate that was set and the detection result (para. 0056, where the second pump target rate is calculated based on the first pump); and controlling a rotation speed of the centrifugal pump in the other one of the first blood circulation device or the second blood circulation device according to the calculated auxiliary flow rate (0056, where the controller controls the pump speed to be in the target).
The examiner notes that per the claim amendments filed 05/13/26, new limitations were introduced. Said limitations include an oxygenator where blood is sent through said oxygenator and where the calculation of the auxiliary flow rate in calculated such that the auxiliary flow rate equals the target flow rate minus the detected flow rate from the blood flow rate sensor.
Regarding the oxygenator, Utsugida teaches that in use the system performs extracorporeal circulation with an artificial lung by operating the pump the draw blood from a patient’s vein, performing gas exchange in the blood using an artificial lung to oxygenate the blood, and then returning the oxygenated blood to the patient’s artery or vein, where said device “substitutes for the functions of the heart and lungs” (para. 0034 of Utsugida). The examiner notes that therefore an artificial or substitute for lungs can be readily combined with a substitute for the heart to circulate blood and oxygenate is when needed, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to provide the system of Burke with an artificial lung on the second pump circuit as a means to oxygenate the blood. The examiner notes that the second pump loop of Burke supplies blood to the pulmonary system and thus to the femoral artery, and as the oxygenated blood of Utsugida is said to be returned to the body in veins or arteries, said combination would still allow the second blood loop of Burke to function in the intended manner. Per said citation of Utsugida, blood flows through the artificial lung.
Regarding the new limitation of “auxiliary flow rate equals the target flow rate minus the detected flow rate from the blood flow rate sensor”, the examiner cites paragraphs of Burke 0054-0058 (previously cited under the rejection of claim 2). Per said citations, blood flow is calculated through each of the pumps, where said calculation is done by sensed data (para. 0055). Per para. 0056 the system calculates a target flow rate and then compares the target to the calculated (sensor data) rate and adjusts the pump up or down to reach the target rate. Per para. 0057, rather than determining a target blood flow, the controller may compare blood flow through the pumps to determine is a predetermined range is satisfied, where the controller then adjusts the pump such that the relationship is achieved. The examiner notes that as a target rate is compared to a sensed rate, where said difference is thus determined (interpreted as the auxiliary rate), and the controller then adjusts the pump based on said difference (auxiliary rate). As such, the prior art is interpreted to read to the claimed invention.
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Burke in view of Utsugida and further in view of Botterbusch.
Regarding claim 8 Burke and Utsugida teach the method of claim 7 wherein the auxiliary flow rate is communicated from the one of the first blood circulation device or the second blood circulation device to the other one of the first blood circulation device or the second blood circulation device (para. 0056 where the flow rate of the first pump is used to control the flow rate of the second pump, where the values are then compared. Para. 0057 also discloses comparing the relationship between the flows).
However, the art fails to teach wherein the target flow rate for the patient to flow to the ascending aorta is set by a medical user.
Botterbusch teaches a heart pumping system and is thus considered analogous to the claimed invention. Botterbusch teaches that the device comprises a controller (30) and a programmer (50), where said programmer “may be conventional laptop loaded with programmed software routines for configuring controller 30 and setting operational parameters that controller 30 uses to control operation of implantable pump 20” (para. 0056). Further, per para. 0056, the programmer is located in a clinician’s office and parameters set may include target flow rate. “When first implanted, the surgeon or clinician may use programmer 50 to communicate initial operating parameters to controller 30”. Therefore, it is interpreted that the clinician sets the target flow rate upon first use, and may make adjustments as detailed in para. 0056. Therefore, as Botterbusch teaches a programmer for allowing a clinician to set various parameters of pump operation within a circulation system, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to provide a clinician programmer for the device of Burke, as Burke discloses communication with outside devices and target setting for flow rate. Doing so would merely involve combining prior art elements (circulation pumping systems with a clinician input to the controller with a circulation pumping system with controller) according to known methods to yield predictable results (that being clinician setting of target values).
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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/MATTHEW WRUBLESKI/Examiner, Art Unit 3781
/ARIANA ZIMBOUSKI/Primary Examiner, Art Unit 3781
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