DETAILED ACTION
Note: The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
This Office action is in response to communications filed October 21, 2025.
Status of Claims
1. Claims 1, 2 and 4-10 are pending and currently under consideration for patentability.
Response to Arguments
2. Applicant's arguments filed July 8, 2025 have been fully considered but they are not persuasive.
In response to applicant's argument that O’Mahony describes automatically restarting the apheresis machine upon resolution of the flow condition and does not describe receiving a user input from an operator and restarting at least one pump by the operator as recited in amended claim 1, examiner respectfully disagrees. While examiner acknowledges O’Mahony’s ability to automatically restart the pumps upon resolution of the flow condition, O’Mahony additionally discloses that when problems are more serious, such as total occlusions or extended partial occlusions or the frequency of partial occlusions being too high, the controller will produce an alarm to call for a nurse ([0008]; [0039]) and the alarm may cease after five minutes of not being cleared by a nurse, and at that time the controller shuts down blood pump and the treatment ([0173]). One having ordinary skill in the art would recognize that more serious situations which require the attendance of a nurse or other medical professional will be treated in a similar manner to existing controllers/systems which issue an alarm, stop the pump, and in response the alarm of an occlusion in the blood circuit, a nurse attends to the patient, inspects the blood pump and associate catheters, and restarts the pump, as suggested by O’Mahony in paragraph [0005]. Therefore, in situations where the nurse responds to the alarm within five minutes, inspects the blood pump and associated catheters, and solves the issue – the nurse will then provide a user input of clearing the alarm and subsequently restarting the pump. Accordingly, while applicant’s amendments necessitated a new grounds of rejection to address the new limitations, Franano, Holmes, Lee, and O’Mahony are maintained as the references for rejecting independent claim 1, as seen 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.
3. Claim(s) 1, 2, 4-6 and 8-10 are rejected under 35 U.S.C. 103 as being unpatentable over Franano et al. (US 20170258981 A1) in view of Holmes et al. (US PGPUB 2018/0304004) in view of Lee et al. (WO 2005003738 A2) in view of O’Mahony et al. (US 20030152482 A1).
4. With regard to claims 1, 4 and 10, Franano discloses a method comprising: initiating a draw pump (blood pump, 25; Fig. 1) of an apheresis machine ([0215]): detecting a flow of fluid through the apheresis machine ([0251]); detecting the flow of the fluid is below a predetermined threshold; and in response to detecting the flow of the fluid is below the predetermined threshold, adjusting a rate of the draw pump of the apheresis machine (see where Franano discloses “...a speed control method 680 can detect low flow conditions. When the pump flow rate drops below the safe threshold level to avoid thrombosis of the pump-conduit system 10 at block 682, the pump speed is immediately increased at block 614 and an alarm is triggered...” in [0251] and “... the control system includes sensors in the blood pump or conduits that measure at least one of a blood velocity, a blood flow rate...” in [0034]).
While Franano suggests that the inflow and outflow conduits (20, 30) of the draw pump (25) may be compatible for use with an apheresis machine in an apheresis procedure to facilitate the removal and return of blood from the patient ([0215]), Franano is silent in regard to the method step of initiating a return pump and an anticoagulant pump, in addition to the draw pump.
However, Holmes discloses apheresis methods and systems ([0002]; Figs. 1, 2A), wherein, during use, at least a draw pump (208), a return pump (212) and an anticoagulant pump (216) of an apheresis system (200) are initiated ([0127]; [0130]).
Therefore, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the draw pump disclosed by Franano to be utilized as a draw pump in an apheresis machine which utilizes additional return and anticoagulant pumps, similar to that disclosed by Holmes, in order to facilitate the removal and return of blood from the patient during an apheresis procedure, as suggested by Franano in paragraph [0215].
Further, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the method step of initiating the draw pump of the apheresis machine disclosed by Franano in view of Holmes to further include the initiating of a return pump and an anticoagulant pump, similar to that disclosed by Holmes, in order to better control fluid flow through the apheresis system; namely selectively controlling fluid flow to and or from the donor, while also selectively controlling the flow of anticoagulant throughout the blood component collection set of the apheresis system, as suggested by Holmes in paragraph [0127].
Additionally, while Holmes discloses the use of a color sensor (808, 812, 916-924) to detect the color of the fluid ([0199]; [0204]; [0237-0238]), Franano and Holmes fail to explicitly disclose the step of detecting the flow of fluid comprises using a sensor to detect a color of the fluid; wherein the sensor detects one or more of red, blue or green.
In the analogous art of methods of processing blood (abstract; see also “apheresis” on page 1), Lee discloses wherein detecting characteristics of the flow of the fluid comprises using a sensor to detect a color of the fluid (see lines 2-10 of page 27, wherein Lee discloses using wavelength measurements to optimize the flow conditions in a blood processing device, lines 15-17 of page 42, wherein Lee discloses “...images of the present invention are color images, which provide a measurement of the colors of separated blood components along the separation axis”, and lines 30-32 of page 67, wherein Lee discloses the use of an “optical robot/smart sensor” for measurements). Lee further discloses wherein the sensor detects one or more of red, blue, or green (see the mention of “green light and red light” that can be transmitted, scattered, and detected in lines 2-10 of page 27 of Lee).
Therefore, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the apheresis method disclosed by Franano in view of Holmes to include the method step of detecting characteristics of the flow of the fluid comprises using a sensor to detect a color of the fluid, similar to that disclosed by Lee, since color data of the flow of the fluid can be used to detect the occurrence of hemolysis which is directly related to flow conditions in the apheresis machine, as suggested by Lee in lines 2-10, page 27.
As a final matter, Franano, Holmes and Lee fail to explicitly disclose that the step of adjusting the rate of at least one of the draw pump, return pump, or anticoagulant pump of the apheresis machine includes stopping/turning off at least one of the draw pump, return pump, or anticoagulant pump of the apheresis machine; receiving a user input, from an operator, acknowledging an alarm condition associated with the at least one of the draw pump, the return pump, or the anticoagulant pump of the apheresis machine, the alarm condition being associated with the flow of the fluid being below the predetermined threshold; and restarting, by the operator, at least one of the draw pump, return pump, or anticoagulant pump of the apheresis machine after receiving the user input.
However, within the analogous art of extracorporeal blood circuits (abstract), O’Mahony discloses a method and apparatus for an extracorporeal treatment device to control blood withdrawal and infusion (abstract; Figs. 1, 3), the method comprising: in response to detecting the flow of fluid being below a predetermined threshold, adjusting the rate of one or more pumps (113, 114, 106) of an apheresis machine (100) comprises stopping/turning off the one or more pumps ([0016] and [0038-0039]); receiving a user input (“clearing the alarm/warning”), from an operator (nurse), acknowledging an alarm condition (“alarm to call for nurse” if problem is more serious, “such as total occlusions or extended partial occlusions”, [0008]; “such as the frequency of partial occlusions is too high”, [0039]) associated with the at least one of the pumps (113, 114) of the apheresis machine (100), the alarm condition being associated with the flow of the fluid being below a predetermined threshold ([0051]; [0166]; [0187]); and restarting , by the operator (nurse), at least one of the pumps (113, 114) of the apheresis machine (100) after receiving the user input (“in response to each alarm of an occlusion in the blood circuit, a nurse attends to the patient, inspects the blood pump and associate catheters, and restarts the pump”, [0005]; “the controller may issue an alarm to a nurse if the number of partial occlusions or their frequency exceed threshold values… [the] alarm may cease after five minutes of not being cleared by a nurse, and (at that time) the controller shuts down blood pump and the treatment”, [0173]; therefore, in situations where the nurse responds to the alarm within the five minutes, inspects the blood pump and associated catheters, and solves the issue – the nurse will then provide the user input of clearing the alarm and restarting the pump).
Accordingly, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the pump rate adjusting method step disclosed by Franano in view of Holmes and Lee to include the steps stopping/turning off the one or more pumps and restarting, by the operator, the one or more pumps after receiving a user input, from the operator, acknowledging an alarm condition, similar to that disclosed by O’Mahony, in order to provide a means of stopping blood flow to prevent vein collapse in a patient undergoing apheresis, when a blood flow rate drop is detected, due to occlusion, blood loss, improper component connections or other dangerous conditions, as suggested in [0038] of O’Mahony, and then restoring the withdrawal blood flow rate to its desired flow rate with the assistance of a nurse once detected dangerous conditions are alleviated, as suggested by O’Mahony in [0008], [0010], [0016] and [0170].
5. With regard to claim 2, Franano in view of Holmes, O’Mahony and Lee disclose the method of claim 1. Franano further discloses wherein detecting the flow of the fluid is below the predetermined threshold further comprises detecting a collapsed vein (see [0042], wherein Franano discloses “... the control system monitors blood pressure in the lower extremity vein fluidly connected to the inflow conduit of the blood pump system and adjusts the pump speed to maintain a vein pressure in the desired range that is low enough to result in adequate venous return through the blood pump system while simultaneously avoiding vein wall collapse, or prolapse”).
6. With regard to claim 5, Franano in view of Holmes, O’Mahony and Lee disclose the method of claim 1. Franano further discloses wherein detecting the flow of the fluid is below the predetermined threshold further comprises using a second sensor to detect a flow rate of the fluid (see figs. 36A and 36G, step 604, which consists of measuring the blood flow rate, [0251], and [0033-0034]; [0043-0044]).
7. With regard to claim 6, Franano in view of Holmes, O’Mahony and Lee disclose the method of claim 1. Franano further discloses wherein detecting the flow of the fluid is below the predetermined threshold further comprises using a second sensor to detect a pressure of the flow of the fluid (see [0034], wherein Franano discloses the control system may acquire information from various sources, one of those sources being sensors to measure a blood pressure; also see [0042], wherein Franano discloses “... the control system monitors blood pressure in the lower extremity vein fluidly connected to the inflow conduit of the blood pump system and adjusts the pump speed to maintain a vein pressure in the desired range that is low enough to result in adequate venous return through the blood pump system while simultaneously avoiding vein wall collapse, coaption, or prolapse”; [0033]; [02151]; [0043-0044]).
8. With regard to claim 8, Franano in view of Holmes, O’Mahony and Lee disclose the method of claim 1. Franano, as modified by Holmes above, further discloses wherein adjusting the rate of at least one of the pumps of the apheresis machine comprises sending a control signal to the one or more pumps (see [0283], wherein Franano discloses motor communication signals generated at the blood pump to be sent to the control device and communication signals from the control device to be sent to the blood pump).
9. With regard to claim 9, Franano in view of Holmes, O’Mahony and Lee disclose the method of claim 1. Franano, Holmes, O’Mahony and Lee do not explicitly disclose wherein adjusting the rate of the one or more pumps of the apheresis machine comprises altering a power applied to the one or more pumps, but Franano does disclose wherein flow rate can be estimated using motor input power and pump speed values ([0231-0234]) and wherein the pump speed can be increased when low flow conditions are detected ([0251]). It is also known in the art that adjusting a pump’s power can adjust a pump’s speed, which directly relates to the flow rate of a fluid.
Therefore, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the pump rate adjusting method step disclosed by Franano in view of Holmes, O’Mahony and Lee to comprise altering a power applied to the one or more pumps, in order to efficiently increase and decrease pump speeds when certain flow conditions are detected, as suggested by Franano in paragraph [0251]. Additionally, O’Mahony suggests similar pump speed adjustments in paragraphs [0003] and [0013-0016].
10. Claim(s) 7 is rejected under 35 U.S.C. 103 as being unpatentable over Franano in view of Holmes in view of Lee in view of O’Mahony, as applied to claim 1 above, and further in view of Van Bruggen et al. (US 20180264186 A1).
11. With regard to claim 7, Franano in view of Holmes, O’Mahony and Lee discloses the method of claim 1. While Franano discloses detecting when the fluid flow is below a predetermined threshold ([0034]), Franano, Holmes, O’Mahony and Lee do not disclose wherein detecting the flow of the fluid further comprises using a second sensor to detect a temperature of the fluid.
In the analogous art of the removal of pathogens from blood and blood products (abstract), Van Bruggen teaches wherein detecting characteristics of the flow of the fluid comprises using a sensor to detect a temperature of the fluid (see [0151], wherein Van Bruggen teaches wherein “the system can comprise one or multiple pressure sensors, temperature sensors, air-bubble detectors, flow sensors, and/or other sensors or detectors” and wherein thresholds can be set. Van Bruggen also teaches an example of increasing the output of a pump if the monitored flow rate drops below a certain threshold value and stopping a process if measured variables exceed a threshold value. Furthermore, Van Bruggen teaches in [0151] that it is desirable to maintain blood or blood components at a temperature that is not too high or too low, implying that there is also a minimum threshold the temperature should not fall below).
It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the method disclosed by Franano in view of Holmes, O’Mahony and Lee to include the step of detecting characteristics of the flow of the fluid using a sensor to detect a temperature of the fluid, similar to that disclosed by Van Bruggen, since it is desirable to maintain the blood or blood components near blood temperature ([0151] of Van Bruggen) during apheresis, as it is known to those of ordinary skill in the art that temperatures that are too warm or too cool can cause harm to a patient.
Conclusion
12. 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.
13. Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANDREW J MENSH whose telephone number is (571)270-1594. The examiner can normally be reached M-F 9 a.m. - 6 p.m..
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sarah Al-Hashimi can be reached on (571)272-7159. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ANDREW J MENSH/Primary Examiner, Art Unit 3781