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 Arguments
The examiner notes that the arguments filed 04/22/2026 that Case fails to teach the limitations of claim 1 alone are found to be persuasive. As such said action is nonfinal and the rejection has been updated to a 103 of Case in view of Lamego, detailed below.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 35-41,43-48 is/are rejected under 35 U.S.C. 103 as being unpatentable over Case US 2020/0222617, provided in the previous office action and IDS, in view of Lamego et al. US 2012/0330112, hereafter Lamego.
Regarding claim 35, Case discloses a blood circuit (fig. 1) including a withdrawal line (para. 0024 where an apheresis procedure is detailed and a needle inserted into the user. Thus, the blood being removed through the needle during apheresis is interpreted to be the withdrawal line), the withdrawal line configured to transmit blood from vasculature of a patient (para. 0024, for the reasons detailed directly above)); an adjustable cuff (cuff 12, inflated by pump (per para. 0014)) configured to receive a portion of a limb of a patient (para. 0012), wherein: the cuff is configured to selectively engage with the limb to apply an external force to the limb and correspondingly inhibit flow of blood within the vasculature of the limb (para. 0006-0008). The examiner notes that per these paragraph citations, the cuff is controlled to be inflated and/or deflated based on data from sensors, where said sensors may include a sensor for measuring blood pressure (per para. 0006 and 0008). Also, per paragraph 0016, in use, the cuff is inflated to stop blood flow through the arm, where the device is then deflated to a desired value to obtain flow. Said flow rate is determined based on the systolic pressure, and thus the blood pressure sensor is indicative of flow rate of blood. Per paragraph 0025, the same sensor is able to determine “flow/pressure of the vein”.
As detailed above under the same rejection in view of paragraphs 0006-0008 and 0016, Case further discloses the cuff is adjustable to change the force applied to the limb and correspondingly change flow of blood from the vasculature the blood circuit. Case discloses and a controller in communication with the cuff and configured to operate the cuff to adjust the force applied to the limb of the patient (para. 0016, 0025), wherein: the controller is configured to monitor venous flow rate using one or more physiological sensors (abstract, para. 0025, sensors 28 and 30); and the controller is configured to operate the cuff to adjust the force applied to the limb based on changes in the monitored venous flow rate (para. 0025), including: the controller is configured to operate the cuff and increase the force applied to the limb based on a decrease in the monitored venous flow rate; or the controller is configured to operate the cuff and decrease the force applied to the limb based on an increase in the monitored venous flow rate (para. 0025). The examiner notes that while this does not teach away from increasing the force applied to the limb based on a decrease in flow rate (understood by examiner to continue to decrease flow rate) decreasing the force applied to the limb based on an increase in flow rate (understood by examiner to continue to increase flow rate), the controller operation of Case is not disclosed to perform this operation.
Lamego teaches a patient monitoring system comprising an inflatable cuff and is thus considered analogous to the claimed invention. Lamego teaches that in use, the cuff inflates, where a sensor is configured to detect variations in pressure in the artery based on blood flow (para. 0099). The cuff continues to inflates, further obstructing (thus decreasing blood flow) the artery, where once the artery is fully occluded, a valve is actuated allowing the cuff to deflate (para. 0100). Similar to the inflation cycle, as the cuff deflates, the sensor beings to observe increased pressure oscillations (thus increased blood flow), and the cuff continues to deflate (para. 0101). Therefore, based on the disclosure, the device of Lamego inflates/deflates, measures and determines blood pressure and blood flow, and then continues to inflate/deflate. The inflation/deflation continues until it is determined that a threshold is reached where said thresholds include (for inflated) until artery is completely occluded determined by a decreased variation in pressure as taught by para. 0100 and (for deflated) until the artery has no pressure exerted on it by the cuff and the pressure oscillations are significantly increased (para. 0101). This information can be seen in the graphs in figures 4a-c. Further, as seen in figure 5B, a flow chart detailing operation can be seen where the cuff is inflated (step 550), and a threshold pressure is checked (552). If the threshold is not met, the cuff continues to inflate. Thus, it is interpreted that the device inflates/deflates, checks the pressure (indicative of blood flow as detailed above and paragraphs 0099-0101), and continues to inflate/deflate based on said pressure increase/decrease until the thresholds are met. Therefore, as Lamego teaches that prior to a switch between inflation/deflation, pressure and flow can be monitored and checked to continue inflation/deflation until a threshold point (artery fully occluded or fully opened), it would have been obvious to configure the control of Case to perform the same action, where if blood flow is sensed to be decreasing but not at max occlusion, the controller operates the cuff to keep inflating (increase pressure) to further decrease blood flow, and vice versa during deflation. Doing so would require applying a known technique (checking sensed values during inflation and deflation and comparing them to a threshold to continue inflation/deflation) to a known device (blood circuit) ready for improvement to yield predictable results (that being continuing an increasing pressure in a cuff until occlusion of the artery and continuing a decreasing pressure in a cuff until the artery is open) and thus a prima facie case of obviousness exists.
Regarding claim 36, Case and Lamego teach the blood filtration system of claim 35, wherein the cuff is configured to inhibit distal blood flow in the vasculature and correspondingly redirect the blood flow into the withdrawal line. The examiner notes that as detailed under the rejection of claim 35, the cuff of Case inhibits blood flow and blood is removed from a patient through a withdraw line. As such it is interpreted that the device of Case reads to the claimed limitation. Should applicant disagree the examiner notes that per the MPEP section 2114 section II “"[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 Case disclose a blood collection device including a cuff that is disclosed to inhibit flow through the vasculature and further discloses a withdrawal line through which blood is removed, Case is understood to teach the required structure and thus reads to the claimed function of “inhibit distal blood flow in the vasculature and correspondingly redirect the blood flow into the withdrawal line”. As such Case reads to the claimed limitation.
Regarding claim 37, Case and Lamego teach the blood filtration system of claim 35, wherein the cuff is configured to inhibit venous return within the limb. Per paragraph Case 0016, in use, the cuff is inflated to stop blood flow through the arm, where the device is then deflated to a desired value to obtain flow. Said flow rate is determined based on the systolic pressure, and thus the blood pressure sensor is indicative of flow rate of blood. The blood is removed from the patient through a withdrawal line as detailed under the rejection of claim 35. The examiner notes that per the MPEP section 2114 section II “"[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 Case disclose a blood collection device including a cuff that is disclosed to inhibit flow through the vasculature, Case is understood to teach the required structure and thus reads to the claimed function of “to inhibit venous return within the limb”. As such Case reads to the claimed limitation.
Regarding claim 38, Case and Lamego teach the blood filtration system of claim 35, wherein: the cuff is configured to inhibit venous return within the limb; and the cuff is configured to permit arterial inflow into the limb. Per paragraph Case 0016, in use, the cuff is inflated to stop blood flow through the arm, where the device is then deflated to a desired value to obtain flow. Said flow rate is determined based on the systolic pressure, and thus the blood pressure sensor is indicative of flow rate of blood. The blood is removed from the patient through a withdrawal line as detailed under the rejection of claim 35. The examiner notes that per the MPEP section 2114 section II “"[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 Case disclose a blood collection device including a cuff that is disclosed to inhibit flow through the vasculature, Case is understood to teach the required structure and thus reads to the claimed function of “to inhibit venous return within the limb” and “permit arterial inflow”. As such Case reads to the claimed limitation.
Per the amendments filed 04/22/2026, the claim requires that the blood flow circuit includes an infusion line configured to transmit blood into the vasculature of a patient, where the cuff is more proximal on the limb than the input of the withdrawal line and more distal on the limb than the output of the infusion line. The examiner notes that per Case paragraph 0012 the cuff is placed around an arm, where the cuff inflates to stop blood flow through the vessels in the cuffed arm (para. 0016 of Case). Further, per para. 0026, the needle (withdrawal line) is placed in the crease of the elbow. Based on said disclosure, and the function of the device it is interpreted that the cuff “on the arm” is more proximal on the arm than a withdrawal input at the elbow, as para. 0026 teaches that said elbow area is warmed/heated, where said heating is done by the cuff and therefore the blood must pass through the heated cuff to be warmed at the elbow. Further, per para. 0027, Case teaches that there is a blood return line, however the return side is not disclosed to be above the cuff (thus the cuff is more distal on the arm). While it can be argued that as blood flow is cut off during use of the cuff, the return would be above the cuff to allow the return blood to flow into the body, this is not specifically stated by case. The examiner notes however that per MPEP Section 2144.04 VI C In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950) (Claims to a hydraulic power press which read on the prior art except with regard to the position of the starting switch were held unpatentable because shifting the position of the starting switch would not have modified the operation of the device.) The examiner notes therefore, as the return line is configured to flow blood back into the body, and positioning the return line further up the arm from the cuff would reasonably perform the same function of returning blood to the body, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to place the return line above the cuff (thus having the cuff more distal on the arm) as an obviousness rearrangement of parts.
Regarding claim 39, Case and Lamego teach the blood filtration system of claim 35, wherein: the controller is configured to compare the monitored venous flow rate with a venous flow rate threshold; and the controller is configured to operate the cuff to adjust the force applied to the limb based on the comparison of the monitored venous flow rate with the venous flow rate threshold (Case para. 0025, figure 3). Per paragraph 0025 of Case, the controller monitors the flow rate/pressure and then adjusts the cuff, as needed, to keep the rate/pressure at an acceptable level. The examiner further notes that in view of Lamego, during the inflation of the cuff the sensor data is checked to compare to a threshold, where the cuff continues to inflate if the threshold is not met.
Regarding claim 40, Case and Lamego teach the blood filtration system of claim 35, wherein the withdrawal line is configured for communication with a first portion of the vasculature and the physiological sensors are configured to determine the venous flow rate of a second portion of the vasculature. The examiner notes that Case’s sensor (30) can be seen in figures 1 and 2 as being incorporated or within the cuff (see Case para. 0015,0017 disclosing various location in which sensor can be located). The examiner notes that as the needle is separate from the cuff and is positioned, preferably, in the crook of the elbow, the withdraw line and sensor would be located at different locations within the vasculature and thus it is interpreted that the withdraw line is in communication with a first portion and the sensor is at a second portion of the vasculature.
Regarding claim 41, Case and Lamego teach the blood filtration system of claim 35, further comprising the one or more physiological sensors. The examiner notes that as detailed under the rejection of claim 35, the device may comprise sensors (Case 28 and 30).
Regarding claim 42, Case and Lamego teach the blood filtration system of claim 35, wherein: the controller is configured to operate the cuff and increase the force applied to the limb based on a decrease in the monitored venous flow rate; and the controller is configured to operate the cuff and decrease the force applied to the limb based on an increase in the monitored venous flow rate. The examiner notes that as detailed under the rejection of claim 35, as Lamego teaches that prior to a switch between inflation/deflation, pressure and flow can be monitored and checked to continue inflation/deflation until a threshold point (artery fully occluded or fully opened), it would have been obvious to configure the control of Case to perform the same action, where if blood flow is sensed to be decreasing but not at max occlusion, the controller operates the cuff to keep inflating (increase pressure) to further decrease blood flow, and vice versa during deflation. Doing so would require applying a known technique (checking sensed values during inflation and deflation and comparing them to a threshold to continue inflation/deflation) to a known device (blood circuit) ready for improvement to yield predictable results (that being continuing an increasing pressure in a cuff until occlusion of the artery and continuing a decreasing pressure in a cuff until the artery is open) and thus a prima facie case of obviousness exists. As such the prior art combination reads to the claimed limitation.
Regarding claim 43, Case and Lamego teach the blood filtration system of claim 35, wherein: the one or more physiological sensors are configured to determine a venous pressure of the patient (Case para. 0017); the controller is in communication with the one or more physiological sensors (Case para. 0025); and the controller is configured to operate the cuff to adjust the force applied to the limb in correspondence with the determined venous pressure (Case para. 0025). The examiner further notes that in view of Lamego, during the inflation of the cuff the sensor data is checked to compare to a threshold, where the cuff continues to inflate if the threshold is not met.
Regarding claim 44, Case and Lamego teach the blood filtration system of claim 43, wherein the controller is configured to adjust a cuff pressure corresponding to the force applied to the limb such that the cuff pressure is greater than or equal to the venous pressure (Case para. 0025, where the cuff pressure (inflation of the cuff) is adjusted based on the sensor parameters as compared to an acceptable level). In the example given, when the flow rate/pressure falls below a desired level the cuff is inflated such that the flow rate/pressure is increased back to the desired level. As such Case reads to the claimed limitation. Should applicant argue that the interpretation provided above is incorrect, the examiner notes that per the MPEP section 2114 section II “"[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 Case disclose a blood collection device including a cuff that increases or decreases in pressure by use of a controller, such that the corresponding flow rate/pressure returns to a desired value, Case is understood to teach the required structure and thus reads to the claimed function of “adjusting the cuff pressure such that the cuff pressure is greater than or equal to the venous pressure”. As such Case reads to the claimed limitation.
Regarding claim 45, Case and Lamego teach the blood filtration system of claim 35, wherein the controller is configured to operate the cuff to allow arterial inflow into the limb in correspondence with inhibiting venous return from the limb. Per Case paragraph 0016, in use, the cuff is inflated to stop blood flow through the arm, where the device is then deflated to a desired value to obtain flow. Said flow rate is determined based on the systolic pressure, and thus the blood pressure sensor is indicative of flow rate of blood. The blood is removed from the patient through a withdrawal line as detailed under the rejection of claim 35. The examiner notes that per the MPEP section 2114 section II “"[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 Case disclose a blood collection device including a cuff that is disclosed to inhibit flow through the vasculature, Case is understood to teach the required structure and thus reads to the claimed function of “to inhibit venous return within the limb” and “permit arterial inflow”. As such Case reads to the claimed limitation.
Per the amendments filed 04/22/2026, the claim requires that the blood flow circuit includes an infusion line configured to transmit blood into the vasculature of a patient, where the cuff is more proximal on the limb than the input of the withdrawal line and more distal on the limb than the output of the infusion line. The examiner notes that per Case paragraph 0012 the cuff is placed around an arm, where the cuff inflates to stop blood flow through the vessels in the cuffed arm (para. 0016 of Case). Further, per Case para. 0026, the needle (withdrawal line) is placed in the crease of the elbow. Based on said disclosure, and the function of the device it is interpreted that the cuff “on the arm” is more proximal on the arm than a withdrawal input at the elbow, as para. 0026 teaches that said elbow area is warmed/heated, where said heating is done by the cuff and therefore the blood must pass through the heated cuff to be warmed at the elbow. Further, per para. 0027, Case teaches that there is a blood return line, however the return side is not disclosed to be above the cuff (thus the cuff is more distal on the arm). While it can be argued that as blood flow is cut off during use of the cuff, the return would be above the cuff to allow the return blood to flow into the body, this is not specifically stated by case. The examiner notes however that per MPEP Section 2144.04 VI C In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950) (Claims to a hydraulic power press which read on the prior art except with regard to the position of the starting switch were held unpatentable because shifting the position of the starting switch would not have modified the operation of the device.) The examiner notes therefore, as the return line is configured to flow blood back into the body, and positioning the return line further up the arm from the cuff would reasonably perform the same function of returning blood to the body, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to place the return line above the cuff (thus having the cuff more distal on the arm) as an obviousness rearrangement of parts.
Regarding claim 46, Case and Lamego teach the blood filtration system of claim 45, wherein the one or more physiological sensors are configured to determine one or more of a venous pressure or an arterial pressure of the patient (para. 0017), wherein the controller is configured to adjust the force applied to the limb to correspondingly apply a pressure that is greater than or equal to the venous pressure (Case para. 0025, where the cuff pressure (inflation of the cuff) is adjusted based on the sensor parameters as compared to an acceptable level). In the example given, when the flow rate/pressure falls below a desired level the cuff is inflated such that the flow rate/pressure is increased back to the desired level. As such Case reads to the claimed limitation. The examiner further notes that in view of Lamego, during the inflation of the cuff the sensor data is checked to compare to a threshold, where the cuff continues to inflate if the threshold is not met.
Regarding claim 47, Case and Lamego teach the blood filtration system of claim 46, wherein the controller is configured to adjust the force applied to the limb to correspondingly apply a pressure that is less than or equal to one or more of systolic arterial pressure or diastolic arterial pressure (Case para. 0016). Per para. 0016 Case discloses that the cuff is initially inflated to a level that stops blood flow through the blood vessels of the cuffed arm. The cuff is then deflated by the controller via the deflation valve of the device to a pressure below the systolic pressure so that blood once again flows through the arm. AS such Case reads to the claimed limitation.
Regarding claim 48, Case and Lamego teach the blood filtration system of claim 35, wherein the limb of the patient includes an arm of the patient (Case para. 0013).
Claim(s) 49 is/are rejected under 35 U.S.C. 103 as being unpatentable over Case in view of Lamego and further in view of Hill et al. US 20030216775 A1 hereafter Hill.
Regarding claim 49 The blood filtration system of claim 35, wherein the limb of the patient may be an arm or other limb (para. 0012, where an other limb may be interpreted to be a leg since an arm is disclosed). However, there is no specific disclosure that the “other” limb is a leg of the patient.
Hill teaches a device for controlling blood flow in a patient and is thus considered analogous to the claimed invention. Hill teaches that the device comprises a compression member, such as a cuff, that compresses an appropriate limb such as an arm or leg to achieve desired compression on a patient’s body (para. 0032). Said compression allows for controlling flow of blood (para. 0015). Therefore as Case teaches the cuff and blood system may be applied to an arm or other limb, and Hill teaches that blood flow controlling devices such as cuffs may be applied to arms and legs, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to use the cuff of Case on the leg of a patient, since Hill teaches that arms and legs are both suitable limbs for placing a blood flow controlling cuff. Doing so merely involves combining prior art elements according to known methods (applying a limb cuff to an arm or leg) to yield predictable results (controlling of blood flow) and thus a prima facie case of obviousness exists.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Ganske et al. US 20170273695 A1, disclosing a system comprising a cuff, where said cuff’s inflation is controlled by a controller.
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/MATTHEW WRUBLESKI/Examiner, Art Unit 3781
/ARIANA ZIMBOUSKI/Primary Examiner, Art Unit 3781
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