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 .
DETAILED ACTION
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 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.
Response to Amendments
Applicant’s amendments and response filed Oct. 10, 2025 have been received and entered into the case.
Status of the Claims
Claims 1-20 are currently pending.
Claims 1, 8, 9, 11 and 13 are amended.
Claims 1-20 have been considered on the merits.
Claim Objections
The claim objections are withdrawn due to amendment.
Claim Rejections - 35 USC § 112
The claim rejections under 35 USC § 112, (b) or second paragraph (pre-AIA ), are withdrawn due to amendment. New claim rejections under 35 USC § 112, (b) or second paragraph (pre-AIA ) have been added to address the claim amendments.
Claim Rejections - 35 USC § 103
New claim rejections under 35 USC § 103 have been added to address the claim amendments.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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.
Claims 1-6 are rejected under 35 U.S.C. 103 as being unpatentable over Owen et al. (US 6,673,594 B1) (ref. of record) in view of Yarmush et al. (US 2014/0030231 A1) (ref. of record).
With respect to claim 1, Owen discloses an apparatus (a system) for perfusing an organ to monitor, sustain and/or restore the viability of the organ and/or for transporting and/or storing the organ (Col. 1 lines 13-16 and Col. 3 lines 45-57). Further with respect to the limitations of the system being enabled for sustained normothermic or subnormothermic of claim 1, the perfusion system, and the temperature management system of claim 1 part 3, and the perfusion pump pumping a perfusion solution at the desired temperature through the kidney of claim 2, Owen discloses the organ perfusion apparatus and monitor, sustains and/or restores organ viability by perfusing the organ at hypothermic (subnormothermic) and/or normothermic temperatures (normothermic perfusion mode) preferably after flushing of the organ such as by hypothermic flushing followed by static organ storage and/or organ perfusion at hypothermic temperatures for transport and/or storage of the organ (Col. 3 lines 45-57). Further with respect to claim 1, Owen discloses the perfusion apparatus may be used for various organs, such as the kidneys (Col. 5 lines 20-24).
Owen discloses in the hypothermic mode, the organ is perfused with a medical fluid (the claimed “perfusate”) (Col. 4 lines 50-51 and Col. 34 lines 47-55). Owen discloses the medical fluid is preferably fed into the organ by pressure from an intermediary tank which has a low pressure head so over-pressurization of the organ is avoided (Col. 4 lines 59-61).
With respect to the gas bubble of claim 1 part 1, Owen discloses a bubble detection system may be installed to sense bubbles in the perfusate (Col. 14 lines 34-42 and Col. 18 lines 11- 21). Owen discloses an air sensor and sensor board are preferably used (Col. 18 lines 11- 21). Owen discloses the output of the sensor activates a debubbler system, such as an open solenoid valve, to rid bubbles from the perfusate flow prior to organ introduction (Col. 18 lines 11- 21). Owen discloses as with all of the sensors and detectors in the system, the bubble detector may be positioned at any point in the system that is effective based on the particular parameters or design characteristics of the system (Col. 18 lines 11- 21).
With respect to the limitations of a perfusion system operably coupled with at least one orifice of the kidney, the perfusion system circulating perfusate through the kidney, the perfusion system enabling monitoring and adjustment of the perfusate as the perfusate circulates of claim 1 part 2, Owen discloses in the normothermic perfusion mode, gross organ perfusion pressure is preferably provided by a pneumatically pressurized medical fluid reservoir controlled in response to a sensor disposed in an end of tubing placed in the organ, which may be used in combination with a stepping motor/cam valve or pinch valve which provides for perfusion pressure fine tuning, prevents over-pressurization and/or provides emergency flow cut-off (Col. 4 lines 20-27).
With respect to the limitation of temperature management system maintaining the solution bath and the perfusate at a desired temperature claim 1, part 3, Owen discloses the medical fluid (“perfusate) within reservoir 10 (“solution bath”) is preferably brought to a predetermined temperature by a first thermoelectric unit 30a in heat transfer communication with the reservoir 10 (Col. 9 lines 44-58). Owen teaches the temperature management system capable of maintaining the perfusion solution and the fluid within the solution bath simultaneously (Col. 9 line 16-58 and Col. 14 lines 3-5, Col. 17 lines 16-31, Co. 35 lines 25-37). Owen teaches the transporter contains thermal insulation (Col. 15 lines 49-54).
With respect to the limitation of an oxygenator supplying oxygen to the perfusate, enabling carbon dioxide to escape from the kidney of claim 3, Owen discloses an oxygenator 110 which comprises a filter which is a CO2 scrubber 100 and that the CO2 is removed by vacuum venting (Col. 19 line 52 to Col. 20 line 2). With respect to the limitation of the claimed tank preventing recirculation of gas bubbles by allowing gas bubbles to exit an exposed top surface of the solution bath of claim 1, part 1, Owen discloses the cassette 65 (“tank”) may be provided with a closeable air vent 61 (see, for example, FIG. 11D and Col. 10 lines 10-11).
With respect to the limitation of coupled with at least one orifice of the kidney in claim 1, part 2 and the tank limiting exposure or the kidney to vacuum pressure of claim 1, part 1, Owen discloses gross organ perfusion pressure is preferably provided by a pneumatically pressurized medical fluid reservoir controlled in response to a sensor disposed in an end of tubing placed in the organ, which may be used in combination with a stepping motor/cam valve or pinch valve which provides for perfusion pressure fine tuning and prevents over- pressurization (Col. 4 lines 20-40).
Owen discloses the fluid in the organ bath may be collected, or the venous outflow may be captured, to be analyzed (Col. 26 lines 19-36). Owen discloses the fluid is collected and passed via transfer line 2860 to analyzer 2820 (Col. 26 lines 19-36). Owen discloses transfer line 2860 may also be provided with a separate heating and cooling unit. Owen discloses after the fluid is analyzed; it may be collected in a waste receptacle 3090 (Col. 26 lines 19-36).
With respect to the limitation of tank holding a solution bath, the solution bath surrounding the kidney of claim 1, part 1, Owen discloses preferably the cassette 65 includes side walls 67a, a bottom wall 67b and an organ supporting surface 66, which is preferably formed of a porous or mesh material to allow fluids to pass therethrough (Col. 10 lines 1-4).
With respect to claim 1, part 4, Owen discloses a transporter (the claimed “carrying case”) enabling transport of the kidney (Fig. 19 and Col. 6 lines 48-49). With respect to claim 1, part 4, Owen discloses the transporter comprises the cassette and pump (the claimed “perfusion system”) and that transporter 1900 of Fig. 21 is intended to provide hypothermic perfusion and may operate at any temperature (the claimed “temperature management system”) (Col. 13 lines 59-66). With respect to the limitation of temperature management system includes insulation” of claim 1, part 3, Owen discloses that Fig. 23 shows the transporter 1900 comprises insulation 2320 (Col. 15 lines 49-51). With respect to the limitations of at least one sensor collecting at least one perfusate characteristic of the perfusate and at least one kidney characteristic of the kidney of claim 6, Owen discloses the transporter has a control panel 1920 which may display characteristics, such as, infusion temperature and vascular resistance of an organ (Col. 15 lines 4-14).
With respect to the limitation of an infusion pump pumping a selected solution into the tank of claim 4, Owen teaches collected effluent medical fluid is pumped out by the pump 80 via tubing 81 through the filter unit 82 and then returned to the organ bath or tank (Col. 33 lines 38-45).
With respect to the limitation of an infusion pump pumping a selected solution into the kidney of claim 5, Owen teaches a pump for pumping perfusate into the organ (Col. 4 lines 27-31).
Owen does not teach the system where the perfusion system draws perfusate from the solution bath surrounding the kidney as recited in claim 1, part 2. However, Yarmush teaches a system for sustaining an organ in normothermic or subnormothermic where the perfusate is continuously recycled in a closed circuit and the organ is bathed in the perfusate in a perfusion chamber (0488, 0514, 0554-0555, Fig. 1A and Fig. 54). Accordingly, at the effective time of filing of the claimed invention, one of ordinary skill in the art would have been motivated to modify the system of Owen to include a feature of drawing the perfusate from the solution bath to perfuse the organ for the benefit of maintaining a closed system as taught by Yarmush. It would have been obvious to one of ordinary skill in the art to make such a modification to the system of Owen, since similar systems for perfusing organs to maintain the organs were known to use such features as taught by Yarmush. For these reasons as well, one of ordinary skill in the art would have had a reasonable expectation of success in making such a modification.
Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the effective time of filing of the invention, especially in the absence of evidence to the contrary.
Claim 7 is rejected under 35 U.S.C. 103(a) as being unpatentable over Owen in view of Yarmush (as applied to claims 1-6 above), and further in view of Anderson et al. (US 2015/0017627 A1) (ref. of record).
The teachings of Owen and Yarmush can be found in the previous rejection above.
Owens differs from the claims in that the document fails to disclose a container collecting urine from the kidney. However, Anderson cures the deficiency.
With respect to the limitation of the urine indicating at least one kidney characteristic of the kidney of claim 7, Anderson discloses a system for hypothermic transport of samples such as tissues for donation (title and abstract). Anderson discloses urine was collected from kidneys after 90 minutes and urine output measured to evaluate kidney function ([0231]).
It would have been obvious to one of ordinary skill to modify the Owen system by including a collection container collecting urine to determine at least one kidney characteristic as suggested by Anderson in view of the teachings of Anderson measuring urine output to determine kidney function. One of ordinary skill would have had a reasonable expectation of success in modifying the Owen system by including a collection container in view of the teachings of Anderson that kidney can be stored for up to 24 hours using cold storage without a substantial decrease in functionality ([0234]). One of ordinary skill would have been motivated to include a urine collection container in the Owen system in order to determine the effect transport had on kidney function ([0234]).
Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the effective time of filing of the invention, especially in the absence of evidence to the contrary.
Claims 8-15 are rejected under 35 U.S.C. 103 as being unpatentable over Owen et al. (US 6,673,594 B1) (ref. of record) in view of Yarmush et al. (US 2014/0030231 A1) (ref. of record) and Anderson et al. (US 2015/0017627 A1) (ref. of record).
With respect to claim 8, Owen discloses a method of perfusing an organ to monitor, sustain and/or restore the viability of the organ and/or for transporting and/or storing the organ by perfusing the organ at hypothermic and/or normothermic temperatures (normothermic perfusion mode) (Col. 1 lines 13-16 and Col. 3 lines 45-57). Further with respect to claim 8, Owen discloses the perfusion method may be used for various organs, such as the kidneys (Col. 5 lines 20-24). Owen teaches that the kidney has an artery (Col. 11 lines 52-54).
With respect to the limitation of a tank housing the kidney within a perfusion system of claim 8, Owen discloses an organ chamber with a cassette 65 which houses the kidney (Col. 5 lines 25-33 and Col. 9 lines 59-62).
With respect to the limitation of the kidney being transported from a donor to a recipient of claim 8, Owen discloses the kidney can be a donor kidney and that (95) the organ may be perfused at normothermic temperatures to sustain, monitor and/or restore its viability prior to being perfused at hypothermic temperatures preparatory to storage and/or transport and then the organ may be transplanted into a recipient while remaining at hypothermic temperatures (Col. 5 lines 20-24, and Col. 29 lines 50-64).
With respect to the first recited step of claim 8, placing a kidney into the tank and connecting the renal artery to the perfusion system, Owen teaches placing a kidney into the organ chamber in a cassette with a chair and connecting a renal artery to the perfusion system (Col. 9 lines 59-67 and Col. 11 line 10 to Col. 12 line 22).
With respect to the second recited step of claim 8, pumping perfusate from the tank using a pump in the perfusion system into the renal artery and where the kidney is surrounded by a solution bath filling a tank, Owen teaches the pumping of the perfusate into the organ (Col. 4 lines 27-31, Col. 5 lines 25-33 and Col. 9 lines 59-62).
With respect to the third recited step of claim 8, monitoring perfusate characteristics via sensors in the perfusion system of the perfusate, Owen discloses during operation the conditions experienced by the system, in particular by the organ and the perfusate, are detected and monitored (Col. 36 lines 23-31). Owen discloses the detected operating conditions are compared with prestored operating conditions. Owen discloses a signal can then be generated indicative of organ viability based on the comparison and that the various detectors, sensors and monitoring devices are described above, but include at least a pressure sensor, a pH detector, an oxygen sensor and a flow meter (Col. 36 lines 23-31).
With respect to the fourth recited step of claim 8, Owen teaches the temperature management system maintaining the perfusion solution and the fluid within the solution bath simultaneously (Col. 9 line 16-58 and Col. 14 lines 3-5, Col. 17 lines 16-31, Co. 35 lines 25-37).
With respect to the fifth recited step of claim 8, of adjusting, via a control system connected to the sensor, at least one characteristic of the perfusate based on data for the sensors while the kidney is being transported, it would have been obvious to one of ordinary skill to monitor and adjust the perfusate characteristics while the kidney is being transported based on the teachings of Owen. Owen teaches that the pumps used for machine perfusion may increase the risk of over pressurization of the organ (Col. 1 line 66 to Col. 2 line 2) and that sensors and monitoring devices are used detect pressure, pH, oxygen and flow (Col. 36 lines 23-31). Additionally, Owen teaches control areas for monitoring and controlling perfusion and monitoring and controlling the temperature of the perfusate and organ (Col. 7 lines 29-39 and Col. 36 lines 32-38). One of ordinary skill would have had a reasonable expectation of success in adjusting the perfusate characteristics in view of the teachings of Owen where the method includes the use of sensors and monitoring devices to detect pressure, pH, oxygen, temperature and flow (Col. 36 lines 23-38). One of ordinary skill would have been motivated to monitor and adjusting the perfusate characteristics while the kidney is being transported in view of the teachings of Owen that the techniques used for assessment of the viability of these machine perfused organs have been a critical factor in limiting the organs from greater use (Col. 2 lines 9-14).
With respect to the limitation of the perfusion system maintaining the perfusate at a pre-selected temperature while the kidney is being transported of claim 9, Owen discloses the medical fluid (“perfusate) within reservoir 10 (“solution bath”) is preferably brought to a predetermined temperature by a first thermoelectric unit 30a in heat transfer communication with the reservoir 10 (Col. 9 lines 44-58).
With respect to the limitation of the perfusion system monitoring the solution bath characteristics of the solution bath of claim 11, part 1, Owens discloses (10) the medical fluid (perfusate) within reservoir 10 is preferably brought to a predetermined temperature by a first thermoelectric unit 30a in heat transfer communication with the reservoir 10. Owens discloses (10) temperature sensor T3 relays the temperature within the reservoir 10 to the microprocessor 150, which adjusts the thermoelectric unit 30a to maintain a desired temperature within the reservoir 10 and/or displays the temperature on a control and display areas 5a for manual adjustment (Col. 9 lines 44-58).
With respect to the limitation of controlling a selector valve and an infusion pump, the selector valve and the infusion pump drawing selected solutions in the solution bath based on solution bath characteristics of claim 11, part 2, Owen discloses the system includes default values based on previously stored values appropriate for the particular organ. Owen discloses the user may also select intermittent perfusion, single pass perfusion, and recirculation perfusion and that depending on the type of perfusion selected, aerobic or anaerobic medical fluids may be specified (Col. 35 line 66 to Col. 36 line 14).
Owen discloses the type of flow control for each selected perfusion mode is set. Owen discloses the flow control selector selects flow control based on at least one of perfusate flow rate, perfusate pH, organ inlet pressure and timed sequences. Owen discloses in the preferred embodiment, the flow control is based on detected pressure at the perfusion inlet to the organ and that the flow of the medical fluid is then based on the selected perfusion mode and flow control (Col. 36 line 15-22).
With respect to the limitation of controlling a temperature management system based on the solution bath characteristics of claim 11, part 3, Owen discloses in operation, as seen in FIG. 15, the basic steps of operation to control perfusion of one or more organs include first inputting organ data. Owen discloses the organ data includes at least the type of organ and the mass. Owen discloses the program will prompt the user to select one or more types of perfusion modes. Owen discloses the types of perfusion modes include hypothermic perfusion, normothermic perfusion, and sequential perfusion using both normothermic and hypothermic perfusion. Owen discloses when both normothermic and hypothermic perfusion are employed, the user can select between medical fluids at different temperatures (Col. 35 line 66 to Col. 36 line 14).
With respect to the limitation of the perfusion system oxygenating the perfusate while the kidney is being transported of claim 12, Owens discloses the medical fluid (“perfusate”) is oxygenated (Col. 3 lines 58-66 and Col. 30 line 65 to Col. 31 line 1). It would have been obvious to one of ordinary skill to oxygenate the kidney during transport in view of the teachings of Owens that the mitochondria of the cells of the organ require oxygen to function (Col. 2 lines 56-64).
Owen silent with respect to whether the kidney has an ureter and does not teach the method where the kidney has an ureter as recited in the preamble of claim 8. Similarly, Owen does not teach the sampling of urine from the ureter and disposing of the sampled urine as recited in claim 10.
However, Anderson teaches a similar method and system for the hypothermic transport of samples such as tissues for donation (title, abstract, 0002). Anderson teaches the method where the perfusate is pumped into the kidney via the renal artery and discloses the kidney included ureters (0228 and 0231). Anderson further teaches the method where urine is collected from kidneys after 90 minutes and urine output is measured to evaluate kidney function (0231). Although, Anderson is silent to whether the urine is saved or disposed of as recited in claim 10, it would have been obvious to one of ordinary skill to dispose of the urine sample once taken as a routine sanitary and since urine is a waste product.
Accordingly, one of ordinary skill in the art would have been motivated to modify the method of Owen to use a kidney with an ureter, to sample urine from the ureter and dispose of the urine for the benefit of being able to evaluate the function of the kidney as taught by Anderson. It would have been obvious to one of ordinary skill in the art to modify the method of Owen to use a kidney with an ureter, to sample urine from the ureter and dispose of the urine, since similar methods of transport and preserving kidneys for transplantation were known to include kidneys with ureters and to evaluate the urine from the ureter as taught by Anderson. Furthermore, one of ordinary skill would have had a reasonable expectation of success in modifying the Owen system by including a kidney having an ureter in view of theses teachings of Anderson.
Owen does not teach the method where the pumping of the perfusate is by a pump in the perfusion system that draws perfusate from the solution bath surrounding the kidney as recited in the second recited step of claim 8. However, Yarmush teaches a method for sustaining an organ in normothermic or subnormothermic where the perfusate is continuously recycled in a closed circuit and the organ is bathed in the perfusate in a perfusion chamber (0488, 0514, 0554-0555, Fig. 1A and Fig. 54). Accordingly, at the effective time of filing of the claimed invention, one of ordinary skill in the art would have been motivated to modify the method of Owen to include a step of drawing the perfusate from the solution bath to perfuse the organ for the benefit of maintaining a closed system as taught by Yarmush. It would have been obvious to one of ordinary skill in the art to make such a modification to the method of Owen, since similar systems for perfusing organs to maintain the organs were known to include such steps as taught by Yarmush. For these reasons as well, one of ordinary skill in the art would have had a reasonable expectation of success in making such a modification.
With respect to the limitation of a system for enabling sustained normothermic or subnormothermic perfusion of an organ with perfusate of claim 13 and the limitation of a thermal management subsystem adjusting temperature of the perfusate according to a pre- selected threshold, the pre-selected threshold being normothermic or subnormothermic of claim 13, part 3, Owen discloses (16) an apparatus and method for perfusing an organ to monitor, sustain and/or restore the viability of the organ and/or for transporting and/or storing the organ. Owen discloses (16) the organ perfusion apparatus and monitor, sustain and/or restore organ viability by perfusing the organ at hypothermic and/or normothermic temperatures (normothermic perfusion mode) preferably after flushing of the organ such as by hypothermic flushing followed by static organ storage and/or organ perfusion at hypothermic temperatures for transport and/or storage of the organ (Col. 3 lines 42-57). Owen discloses the perfusion apparatus may be used for various organs, such as the kidneys (Col. 5 lines 20-24).
With respect to the limitation of the gas management subsystem adjusting gas saturation in the perfusate of claim 13, part 2, Owen discloses a bubble detection system may be installed to sense bubbles in the perfusate. Owen discloses an air sensor and sensor board are preferably used. Owen discloses (the output of the sensor activates a debubbler system, such as an open solenoid valve, to rid bubbles from the perfusate flow prior to organ introduction . Owen discloses as with all of the sensors and detectors in the system, the bubble detector may be positioned at any point in the system that is effective based on the particular parameters or design characteristics of the system (Col. 18 lines 11-21). Owen discloses a bubble trap 2130 removes air bubbles from the perfusate (Col. 14 lines 45-46).
With respect to the limitation of the perfusion subsystem circulating perfusate through the organ of claim 13, part 4 and the thermal management system, the perfusate enabling sustained normothermic or subnormothermic conditions for the organ of claim 13, parts 7 and 8, Owen discloses in the hypothermic mode, the organ is perfused with a medical fluid (the claimed “perfusate”) (Col. 4 lines 49-56). Additionally, Owen teaches the temperature management system maintaining the perfusion solution and the fluid within the solution bath simultaneously (Col. 9 line 16-58 and Col. 14 lines 3-5, Col. 17 lines 16-31, Co. 35 lines 25-37).
With respect to the limitations of the tissue enclosure with a fluid reservoir surrounding an organ contained within and having a platform with a height, and the organ being positioned on the platform of claim 13, parts 1 and 2, Owen discloses an organ chamber 40 which supports a cassette 65 which houses the kidney and which allows fluids to pass therethrough and an organ chair 1800 (Col. 9 lines 59-67, Col. 10 lines 1-32 and Col. 11 lines 11-22). With respect to the limitation of the output management subsystem measuring output from the organ of claim 14, Owens discloses the organ chair can be configured to funnel the venous outflow in a venous outflow sampler 1810 which permits analysis of the perfusate leaving the organ (Col. 11 lines 33-51).
With respect to the limitation of the fluid reservoir having a fluid level, the fluid level being lower than the height of claim 13, part 2, Owen discloses (12) the cassette 65, and more particularly the organ support, opening(s), tubing(s) and/or connection(s), may be specifically tailored to the type of organ and/or size of organ to be perfused (Col. 10 lines 1-32). It would have been obvious to one of ordinary skill to use that amount of fluid giving optimal organ preservation results. One of ordinary skill would have had a reasonable expectation of success in choosing a fluid level giving optimal results in view of the teachings of Owen that organ support may be specifically tailored to the type of organ and/or size of organ to be perfused.
With respect to the limitation of gas management system claim 13 and the gas trap removing gas from the perfusate of claim 15, Owen discloses one or both of gas valves GV1 and GV2 may be vented to the atmosphere (Fig. 2, Col. 7 lines 61 to Col. 8 line and Col. 8 line 6).
Additionally, with respect to claim 14, Owen discloses the perfusion apparatus, transporter, cassette, and organ diagnostic apparatus may be networked to permit remote management, tracking and monitoring of the location and therapeutic and diagnostic parameters of the organ or organs being stored or transported. Owen discloses the information systems may be used to compile historical data of organ transport and storage, and provide cross- referencing with hospital and United Network for Organ Sharing (UNOS) data on the donor and recipient. Owen discloses the systems may also provide outcome data to allow for ready research of perfusion parameters and transplant outcomes (Col. 5 lines 51-61).
Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the effective time of filing of the invention, especially in the absence of evidence to the contrary.
Claims 16, 17, 19 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Owen et al. (US 6,673,594 B1) (ref. of record).
With respect to the limitation of the system comprising a disposable portion, the disposable portion including disposable components and tubing coupling the disposable components together to form a circulation loop, the circulation loop enabling circulation of the perfusate through a fluid reservoir surrounding an organ contained therein of claim 16, part 1, Owen discloses the bubble trap 2130 can be disposable. Owen discloses (38) medical fluid flows through tubing and that all tubing can be disposable (Col. 14 lines 45-51).
With respect to the limitation of the durable portion including a pneumatic system driving the circulation of the perfusate of claim 16, part 2, Owen discloses a durable portion comprising a pneumatic system for controlling the pressure of medical fluid (perfusate) (Col. 4 lines 20-40).
With respect to the limitation of a thermal energy source supplying thermal energy to the perfusate to maintain the circulating perfusate at normothermic or subnormothermic temperatures of claim 16, part 2 and the limitation of a system for enabling sustained normothermic or subnormothermic perfusion of an organ of claim 16, preamble Owen discloses heat is conducted from the walls of the perfusion reservoir and cassette 65 into coolant 2110 enabling control within the desired temperature range (Col. 15 line 45 to Col. 16 line 14).
With respect to the limitation of a control system controlling the pneumatic system and the thermal energy source of claim 16, part 3, Owen discloses an organ diagnostic apparatus may also be provided to produce diagnostic data such as an organ viability index and that the organ diagnostic apparatus includes features of an organ perfusion apparatus, such as sensors and temperature controllers (Col. 5 lines 25-33).
With respect to the limitation of a heat exchanger transferring heat from the thermal energy source to the perfusate of claim 17, Owen discloses (82) the system can comprise a heat exchanger 3080 (Fig. 30 and Col. 26 lines 19-36).
With respect to the limitation of an oxygenator providing oxygen to the perfusate of claim 19, Owen discloses the oxygenator provides oxygen to the medical fluid (perfusate) (Col. 19 line 52 to Col. 20 line 2). With respect to the limitation of the disposable portion of claims 17, 19 and 20, Owen discloses all tubing is preferably disposable, easily replaceable and interchangeable (Col. 17 lines 32-48).
With respect to the limitation of at least one pump pumping the perfusate through the organ, the pneumatic system driving the at least one pump of claim 20, Owen discloses use of pneumatically pressurized and gravity fed fluid pumps configured to avoid over pressurization and that organ perfusion in this system can be performed, e.g., with either hydrostatic perfusion (gravity or pressure fed flow) or peristaltic perfusion by introducing flow to the organ from a peristaltic (roller) pump (Col. 17 line 58 to Col. 18 line 10). Owen discloses all tubing is preferably disposable, easily replaceable and interchangeable (Col. 17 lines 32-48).
It would have been obvious to one of ordinary skill to use disposable components and tubing for the pump in view of the teachings of Owen that all tubing is preferably disposable, easily replaceable and interchangeable (Col. 17 lines 32-48). One of ordinary skill would have had a reasonable expectation of success in using disposable components in view of the teachings of Owen that all tubing is preferably disposable. One of ordinary skill would have been motivated to use disposable components in order to minimize microbial contamination and optimize organ sterility and patient therapy.
Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the effective time of filing of the invention, especially in the absence of evidence to the contrary.
Claim 18 is rejected under 35 U.S.C. 103(a) as being unpatentable over Owen (as applied to claims 16, 17, 19 and 20 above), and further in view of Owen (US 6,014,864) (Owen2)(ref. of record) and Milne et al. (US 2019/0075786 A1) (ref. of record).
The teachings of Owen can be found in the previous rejection above.
The teachings of Owen above are incorporated herein in their entirety. Owen differs from the claims in that the document fails to disclose a heat exchanger comprising a plate and a thermally conductive membrane as recited in claim 18. However, Owen2 and Milne cure the deficiency.
Owen2 discloses a method of cooling fluids includes receiving and allowing expansion of a compressed cryogenic fluid within a chamber, flowing a fluid to be cooled, for example, a medical fluid, past the chamber, and allowing the transfer of heat between the chamber and the fluid to be cooled (Col. 2 lines 42-51). Owen2 discloses (4) the transfer of heat may be accomplished by providing the chamber with at least one wall formed of a material having high thermal conductivity and high resistivity to low temperature (Col. 2 lines 53-57). Owen2 discloses the transfer of heat may be further accomplished by circulating a fluid to be cooled through a fluid path disposed adjacent to the at least one wall, preferably on the opposite side of the wall from the cryogenic fluid (Col. 3 lines 3-10).
Milne discloses a device which is operable to cool samples ([0029]). With respect to the limitation of a second opposing side positioned against a tissue enclosure of claim 18, part 1, Milne discloses the samples may be cooled by conduction of heat therefrom to a cold source such as a cooled material and the cooled material may be in contact with the one or more members, but may particularly be isolated from the sample e.g. from the outer surface of the members, to ensure and maintain a dry system ([0029]).
With respect to the limitation of the plate having a fist side etched with a fluid path and a second opposing side of claim 18, part 1, Milne discloses the cooled material may flow through, in or adjacent to one or more members, as discussed above in relation to heating ([0030]). Milne discloses the cooled material may comprise liquid nitrogen, carbon dioxide, or domestic or industrial refrigerants ([0030]). Milne discloses the thermal connection between the member and the cold source may be indirect through an intermediary element which could be a conductive material, operably in use to transfer heat energy from a member to a cold source ([0031]).
With respect to the limitation of a thermally-conductive membrane having a first membrane side covering the first side of claim 18, part 2 and the limitation of the thermally-conductive membrane having a second opposing membrane side positioned against the thermal energy source of claim 18, last part, Milne discloses the membrane can be flexible and may comprise a thermally conductive material ([0105]). Milne discloses the size of the flexible membrane may be selected on the container size ([0105]).
It would have been obvious to one of ordinary skill to modify the Owen system by using a heat exchanger have a thermally conductive membrane as suggested by Milne in view of the teachings of Owen2 disclosing the transfer of heat may be accomplished by providing the chamber with at least one wall formed of a material having high thermal conductivity and high resistivity to low temperature (Col. 2 lines 53-57). One of ordinary skill would have had a reasonable expectation of success in modifying the Owen method by using a thermally conductive membrane in view of the teachings of Milne, disclosing the thermal connection between the member and the cold source may be indirect through an intermediary element which could be a conductive material, operably in use to transfer heat energy from a member to a cold source ([0031]). One of ordinary skill would have been motivated to use a thermally conductive membrane in view of the teachings of Milne that the membrane is an improvement for freezing samples enclosed within containers.
Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the effective time of filing of the invention, especially in the absence of evidence to the contrary.
Response to Arguments
Applicant's arguments filed Oct. 10, 2025 have been fully considered but they are not persuasive.
With respect to the rejections under 35 U.S.C. § 103, Applicant argues that claim 1 requires that the organ being perfused resided in the reservoir where perfusate is being drawn for circulation and reperfusion whereas the organ being perfused in Owen is a separate container and is perfused from fluid from separate reservoir containers (Remarks pg. 7 para. 5-6, pg. 8 last para., pg. 9-10 bridging para.). In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Owen is being relied upon for many of the limitations of the independent claims including the teaching of an apparatus and method of perfusing a kidney to sustain normothermic or subnormothermic perfusion of an kidney where the perfusion system is coupled with an orifice the kidney and controlling the temperature of the perfusate and solution bath and Yarmush is being relied upon for the recycling of the perfusate from the holding tank. Applicant addressed each prior art reference separately and only with regard to the specific limitations of that reference. However, when the prior art references are taken as a whole, they teach that the skilled artisan knows each step of the method as currently claimed.
Applicant argues that by position the organ within the perfusion tank the temperature of the organ and the perfusate can be maintained simultaneously at the same temperature by providing additional thermal mass that makes it easier to maintain a tightly controlled temperature and reduce thermal shock to the organ from temperature fluctuations (Remarks pg. 7 last para. 1, pg. 8 last para., pg. 9-10 bridging para., pg. 10-11 bridging para., pg. 11 para. 2, pg. 12 para. 1). However, these arguments were not found to be persuasive, since the combined teachings of Owen and Yarmush teach the claimed system and the fact that the inventor has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious. See Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985).
Applicant argues that neither Owen or Yarmush teach the organ within the perfusion tank so that the temperature of the organ and perfusate reservoir can be maintained simultaneously at the same temperature (Remarks pg. 8 para. 2, pg. 9 para. 1, pg. 10 para. 2). The Applicant’s amendments limiting the claims to include the system being capable of maintaining the temperature simultaneously and the method to include maintaining the temperature simultaneously necessitated a new rejection. Applicant’s arguments are drawn to Owen and Yarmush failing to teach this new limitation. However, this new limitation is addressed in the new rejection and is taught by Owen.
Applicant argues an additional benefit of the claimed invention is that by having a relatively large tank of perfusate with a large surface area allows for the escape of gas bubbles so that they are not recirculated to the organ during the perfusion process (Remarks pg. 8 para. 2, pg. 9 para. 2, pg. 10 para. 3). In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., a large tank with a large surface area) are not recited in the rejected claims. Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Additionally, Owen teaches the tank with an air vent to remove air from the tank (see, for example, FIG. 11D and Col. 10 lines 10-11).
Applicant argues that Anderson does not remedy the deficiencies of Owen, since it is cited as disclosing a container to collect waste products from the organ (Remarks pg. 8 para. 3, pg. 10 para. 4). However, this argument was not found to be persuasive, since the arguments with respect to the rejections over Owen were not found to be persuasive as explained above.
Applicant argues that Owen teaches the replenishment of the reservoirs which contain fresh, unused materials during the perfusion period whereas in the claim method the perfusate is fully recirculated (Remarks pg. 10-11 bridging para., pg. 11 last para.). In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Owen is being relied upon for many of the limitations of the independent claims including the teaching of an apparatus and method of perfusing a kidney to sustain normothermic or subnormothermic perfusion of an kidney where the perfusion system is coupled with an orifice the kidney and controlling the temperature of the perfusate and solution bath and Yarmush is being relied upon for the recycling of the perfusate from the holding tank. Applicant addressed each prior art reference separately and only with regard to the specific limitations of that reference. However, when the prior art references are taken as a whole, they teach that the skilled artisan knows each step of the method as currently claimed.
Applicant argues that Milne does not remedy the deficiencies of Owen, since it is cited as disclosing a devices for cooling samples (Remarks pg. 12 para. 2). However, this argument was not found to be persuasive, since the arguments with respect to the rejections over Owen were not found to be persuasive as explained above.
Conclusion
No claims are allowed.
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.
Examiner Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to EMILY ANN CORDAS whose telephone number is (571)272-2905. The examiner can normally be reached on M-F 9:00-5:30 EST.
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/EMILY A CORDAS/Primary Examiner, Art Unit 1632