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 .
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in parent Application No. 63/256,981, filed on October 18, 2021.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-10 and 12-15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hassanein (US20080017194A1).
Regarding claim 1, Hassanein teaches:
A system for growing or supporting an organ, the system comprising (Hassanein; Abstract; Para. [0104]):
an enclosure configured to support the organ therein in a perfusate flow (Hassanein; Para. [0104], Fig. 1, organ chamber assembly (104), perfusion fluid (108)), the enclosure including a perfusate inlet and a perfusate outlet to receive the perfusate flow through the enclosure and through the organ (Hassanein; Paras. [0104] and [0108-0112], Fig. 1, organ chamber assembly (104), perfusion fluid (108), first interface (162) also referred to as the aorta interface or left ventricle interface, second interface (166) also referred to as the pulmonary artery interface or right ventricle interface, third interface (170) also referred to as the pulmonary vein interface or left atrium interface; In one flow mode (retrograde mode) the perfusate inlet is the first interface (162) and the outlet is the second interface (166) with little to no flow out of the third interface (170) and in the other flow mode (normal mode) the perfusate inlet is the third interface (170) and there are two perfusate outlets being the first (162) and second (166) interfaces.);
a perfusate circuit connected to the perfusate inlet and the perfusate outlet and configured to circulate perfusate through the system and the organ (Hassanein; Perfusate circuit is the collection of components in which the perfusion fluid (18) flows through as depicted in Fig. 1);
a perfusion pump connected to the circuit and configured to circulate perfusate through the perfusate circuit (Hassanein; Para. [0104], Fig. 1, organ chamber assembly (104), perfusion fluid (108), perfusion fluid pump (106));
a gas transfer unit connected to the perfusate circuit and configured to transfer gas to
and from the perfusate (Hassanein; Para. [0112], Fig. 1, oxygenator (114), gas flow chamber (176), gas source (172), gas regulator (174));
a sensor connected to the perfusate circuit and configured to produce a sensor signal based on a condition of the perfusate (Hassanein; Paras. [0028], [0144], [0104], Fig. 12, sensor subsystem (147));
an injection system connected to the perfusion circuit; the injection system configured to inject nutrients into the system (Hassanein; Paras. [0113], Fig. 1, nutritional subsystem (115), infusion pump (182), glucose (116), therapeutics and preservatives (118)); and
a controller configured to operate the pump, the gas transfer unit, and the injection
system based on the sensor signal (Hassanein; Para. [0143], controller (150)).
Regarding claim 2, Hassanein teaches all of the elements of the current invention as stated with respect to claim 1. Hassanein further teaches:
The system of claim 1, further comprising: a gas mixture unit connected to the gas transfer unit and configured to deliver gas to the gas transfer unit (Hassanein; Para. [0112], Fig. 1, gas source (172), gas regulator (174); The gas mixture unit as claimed requires only the delivery of gas to the gas transfer unit/system, therefore the gas source of Hassanein reads on this limitation).
Regarding claim 3, Hassanein teaches all of the elements of the current invention as stated with respect to claim 2. Hassanein further teaches:
The system of claim 2, wherein the gas mixture unit delivers one or more of Carbon Dioxide, Dioxygen, Nitrogen, or Argon to the gas transfer unit (Hassanein; Para. [0112]; Carbon dioxide and Oxygen; Dioxygen is the same and equivalent to Oxygen in the colloquial use which is referring to O2 aka Dioxygen).
Regarding claim 4, Hassanein teaches all of the elements of the current invention as stated with respect to claim 3. Hassanein further teaches:
The system of claim 3, further comprising: a gas control valve connected to the gas mixture unit and in communication with the controller (Hassanein; Para. [0112], perfusion fluid oxygenation sensor (140), controller (150), gas regulator (174) which can be a solenoid valve that controls the gas flow, gas flow chamber (176)), the controller configured to operate the control valve to deliver the gas to the gas transfer unit based on the sensor signal (Hassanein; Para. [0112], perfusion fluid oxygenation sensor (140), controller (150), gas regulator (174) which can be a solenoid valve that controls the gas flow, gas flow chamber (176)).
Regarding claim 5, Hassanein teaches all of the elements of the current invention as stated with respect to claim 4. Hassanein further teaches:
The system of claim 4, wherein the sensor is a gas sensor configured to transmit a gas signal to the controller (Hassanein; Paras. [0028], [0030], [0104], [0112], perfusion fluid oxygenation sensor (140)), the controller is configured to determine gas consumption of the organ based on the sensor signal (Hassanein; Paras. [0028], [0030], [0104], [0112], perfusion fluid oxygenation sensor (140)), and wherein the controller is configured to operate the gas valve to supply a gas mixture to the organ based on the determined gas consumption of the organ (Hassanein; Paras. [0104], [0112], perfusion fluid oxygenation sensor (140), controller (150), gas regulator (174) which can be a solenoid valve that controls the gas flow; The gas consumption of the organ is found due to the oxygenation sensor (140) being placed to measure the perfusion fluid leaving the organ chamber (104) and the known control values of the oxygenation of the perfusion fluid (108) entering the organ and as a result the oxygenation sensor value serves the same purpose as the claimed).
Regarding claim 6, Hassanein teaches all of the elements of the current invention as stated with respect to claim 5. Hassanein further teaches:
The system of claim 5, further comprising: a gas meter connected to the gas mixture unit and configured to transmit a gas meter signal to the controller (Hassanein; Para. [0112], gas pressure gauge (178), transducer (132) communicates the gas flow rate to the controller (150)), the controller configured to operate the control valve based on the gas meter signal (Hassanein; Para. [0112], gas regulator (174), gas pressure gauge (178), transducer (132) communicates the gas flow rate to the controller (150)).
Regarding claim 7, Hassanein teaches all of the elements of the current invention as stated with respect to claim 3. Hassanein further teaches:
The system of claim 3, further comprising: a plurality of gas mixture units connected to the gas transfer unit and configured to different gasses or different gas concentrations to the gas transfer unit (Hassanein; Para. [0012], [0112], [0250]; Fig. 1, gas source (172), gas regulator (174); Fig. 34, where the single use module (1002) is an oxygenator (114), gas supplies (172, 1028a, 1028b)).
Regarding claim 8, Hassanein teaches all of the elements of the current invention as stated with respect to claim 7. Hassanein further teaches:
The system of claim 7, further comprising: a plurality of gas control valves each connected to one of the gas mixture units gas mixture units and each in communication with the controller (Hassanein; Para. [0277], gas regulators (174, 1030a, 1030b), gas flow chambers and gas supplies (172, 1028a, 1028b), the gas sources and flow chambers are referred to as a singular entity) the controller configured to operate the plurality of gas control valves to deliver gasses to the gas transfer unit based on the sensor signal (Hassanein; Para. [0277], transducers (132, 1032a, 1032b), controller (150)).
Regarding claim 9, Hassanein teaches all of the elements of the current invention as stated with respect to claim 8. Hassanein further teaches:
The system of claim 8, wherein the sensor is a plurality of gas sensors each configured to transmit a gas signal to the controller (Hassanein; Paras. [0030], one or more oxygen saturation sensors), the controller is configured to determine gas consumption of the organ based on the sensor signals (Hassanein; Paras. [0104], [0112], Fig. 1; perfusion fluid oxygenation sensor (140); The gas consumption of the organ is found due to the oxygenation sensor (140) being placed to measure the perfusion fluid leaving the organ chamber (104) and the known control values of the oxygenation of the perfusion fluid (108) entering the organ and as a result the oxygenation sensor value serves the same purpose as the claimed), and wherein the controller is configured to operate the plurality of gas control valves to supply a gas mixture to the organ based on the determined gas consumption of the organ (Hassanein; Paras.[0104], [0112], perfusion fluid oxygenation sensor (140), gas regulator (174)).
Regarding claim 10, Hassanein teaches all of the elements of the current invention as stated with respect to claim 3. Hassanein further teaches:
The system of claim 3, wherein the gas transfer unit is an oxygenator (Hassanein; Para. [0112], Fig. 1, oxygenator (114), gas flow chamber (176), gas source (172), gas regulator (174)).
Regarding claim 12, Hassanein teaches all of the elements of the current invention as stated with respect to claim 2. Hassanein further teaches:
The system of claim 2, further comprising: a heating system connected to the gas transfer unit to exchange heat with the perfusate through the gas transfer unit (Hassanein; Para. [0276], heater assembly (110)).
Regarding claim 13, Hassanein teaches all of the elements of the current invention as stated with respect to claim 12. Hassanein further teaches:
The system of claim 12, further comprising: an inlet temperature sensor connected to the circuit upstream of the enclosure (Hassanein; Para. [0129], Fig. 1, temperature sensors (120, 122, 124); Temperature sensor (124) is the inlet sensor upstream of the enclosure.), the inlet temperature sensor configured to produce an inlet temperature signal based on an inlet temperature of the perfusate entering the enclosure (Hassanein; Para. [0129], Fig. 1, temperature sensors (120, 122, 124); Temperature sensor (124) is the inlet sensor upstream of the enclosure.); and an outlet temperature sensor connected to the circuit downstream of the enclosure the outlet temperature sensor configured to produce an outlet temperature signal based on an outlet temperature of the perfusate leaving the enclosure (Hassanein; Para. [0129], Fig. 1, temperature sensors (120, 122, 124); Temperature sensor (122) is the outlet sensor downstream of the enclosure.).
Regarding claim 14, Hassanein teaches all of the elements of the current invention as stated with respect to claim 13. Hassanein further teaches:
The system of claim 13, wherein the controller is configured to: receive the inlet temperature signal and the outlet temperature signal (Hassanein; Para. [0104]; Temperature sensors in communication with the control system); and operate the pump, the gas transfer unit, and the heating system based on the inlet temperature signal and the outlet temperature signal (Hassanein; Para. [0104]).
Regarding claim 15, Hassanein teaches all of the elements of the current invention as stated with respect to claim 1. Hassanein further teaches:
The system of claim 1, further comprising: an injection system connected to the perfusate circuit upstream of the enclosure and in communication with the controller (Hassanein; Paras. [0113], ,Fig. 1, nutritional subsystem (115), infusion pump (182)), the controller configured to operate the injection system based on the sensor signal to deliver supplements to the perfusate (Hassanein; Paras. [0113], ,Fig. 1, nutritional subsystem (115), infusion pump (182), glucose (116), therapeutics and preservatives (118)).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
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 16 & 17 are rejected under 35 U.S.C. 103 as being unpatentable over Hassanein (US20080017194A1).
Regarding claim 16, Hassanein teaches all of the elements of the current invention as stated with respect to claim 15.
Hassanein teaches:
The system of claim 15, wherein the injection system includes an injection pump configured to deliver a supplement to the perfusate (Hassanein; Paras. [0113], , Fig. 1, nutritional subsystem (115), glucose (116), therapeutics and preservatives (118), infusion pump (182)), the controller configured to operate the injection pump based on the sensor signal to deliver supplements to the perfusate (Hassanein; Paras. [0113], ,Fig. 1, nutritional subsystem (115), infusion pump (182), glucose (116), therapeutics and preservatives (118)).
Hassanein discloses the claimed invention except for wherein the injection system includes a plurality of injection pumps. It would have been obvious to one of ordinary skill in the art before the effective filing date to include a plurality of injection pumps, since it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. MPEP 2144.04(VI)(B).
Regarding claim 17, Hassanein teaches all of the elements of the current invention as stated with respect to claim 16. Hassanein further teaches:
The system of claim 16, wherein the plurality of injection pumps are each configured to deliver to the perfusate and the organ, one or more of cell culture media, cells, glutamine, glucose, buffer, sodium chloride, essential amino acids, non-essential amino acids, drugs, ammonia (ammonium chloride), HEPES (CsHisN2O4S), Sodium Bicarbonate, Insulin, Epinephrine, Albumin, linoleic acid, dexamethasone, and glucagon (Hassanein; Paras. [0113], , Fig. 1, nutritional subsystem (115), glucose (116), therapeutics and preservatives (118), infusion pump (182)).
Claims 11 & 21 are rejected under 35 U.S.C. 103 as being unpatentable over Hassanein (US20080017194A1) in view of Arndt (US20230024642A1 with a priority date of 22 July 2021).
Regarding claim 11, Hassanein teaches all of the elements of the current invention as stated with respect to claim 10.
Hassanein does not teach:
The system of claim 10, wherein the gas transfer unit includes an air separator.
Arndt teaches:
wherein the oxygenator includes an air separator (Arndt; Para. [0018], oxygen supply (38) is an oxygen concentrator which operates by taking in ambient air and removing nitrogen).
Arndt further teaches that an oxygen concentrator is safer and more convenient than bottled oxygen as it does not include high pressure components and can operate as long as electrical power is available (Arndt; Para. [0018]).
Therefore, it would be obvious for one having ordinary skill in the art before the effective filing date of the claimed invention to modify the oxygenator of Hassanein by including an air separator (oxygen concentrator) as the gas source for an oxygenator as taught by Arndt. The references are analogous since, both Hassanein and Arndt are directed to oxygenation of biological substrates. Arndt teaches that an oxygen concentrator is safer and more convenient than bottled oxygen as it does not include high pressure components and can operate as long as electrical power is available (Arndt; Para. [0018]).This involves applying a known technique (air separator for oxygen source of an oxygenator) to a similar device (an oxygenator for oxygenation of a biological substrate) to yield predictable results (safer and more convenient oxygenation of the biological substrate).
Regarding claim 21, Hassanein teaches all of the elements of the current invention as stated with respect to claim 1.
Hassanein does not teach:
The system of claim 1, further comprising: a secondary perfusate pump connected to the circuit downstream of the perfusate pump and configured to circulate perfusate through a secondary vessel of the organ.
Arndt teaches:
a secondary perfusate pump connected to the circuit downstream of the perfusate pump and configured to circulate perfusate through a secondary vessel of the organ (Arndt; Paras. [0008], [0013-0014], second pump (34); The two inlet connections are for two different vessels of the liver.).
Arndt further teaches that having multiple inlet pumps for perfusate is to allow for the perfusion of more than one veinous inlet, which broadens the variety of organs the device is able to support (Arndt; Para. [0008]).
Therefore, it would be obvious for one having ordinary skill in the art before the effective filing date of the claimed invention to modify the perfusate inlet pump of Hassanein by including another pump meant for a secondary veinous inlet of an organ as taught by Arndt. The references are analogous since, both Hassanein and Arndt are directed towards an apparatus for the perfusion of an organ. Arndt teaches that having multiple inlet pumps for perfusate allows for the perfusion of more than one veinous inlet and broadens the variety of organs the device is able to support (Arndt; Para. [0008]). This involves applying a known technique (a pump for individual veinous inlet of an organ) to a similar device (an organ perfusion apparatus) to yield predictable results (the perfusion of multiple veinous inlets of a target organ).
Claims 18 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Hassanein (US20080017194A1) in view of Svitek (US20150150715A1).
Regarding claim 18, Hassanein teaches all of the elements of the current invention as stated with respect to claim 16.
Hassanein does not teach:
wherein the injection system includes an enclosure supporting the plurality of injection pumps and the supplements. (The recitation of the claim is being interpreted as each pump having an enclosure, whether that is a singular enclosure for the plurality of pumps or each pump within the plurality has its own enclosure.)
Svitek teaches:
wherein the injection system includes an enclosure supporting the injection pump and the supplements (Svitek; Para. [0027], Fig. 2, common housing (110)).
wherein the injection system includes a cooling system configured to cool an environment of the injection system (Svitek; Paras. [0012], [0016], [0028], Fig. 2, pump/heat exchanger device (40); The cooling portion of the pump/heat exchanger is being brought into the system of Hassanein for claim 19)
Svitek further teaches that the housing allows for organizing multiple fluid pathways in isolation from each other and maximizes fluid contact with the heat exchange portion within the housing (Svitek; Paras. [0013-0014]).
Therefore, it would be obvious for one having ordinary skill in the art before the effective filing date of the claimed invention to combine the infusion pump system of Hassanein with the temperature controlled pump housing/enclosure as taught by Svitek. The references are analogous since, both Hassanein and Svitek are directed to pump systems with biological fluids. Svitek teaches that the housing allows for organizing multiple fluid pathways in isolation from each other and maximizes fluid contact with the heat exchange portion within the housing (Svitek; Paras. [0013-0014]). This involves applying a known teaching (an enclosure for pumps containing a heat exchanger) to a similar device (a system of pumps without an enclosure) to yield predictable results (a system of pumps organized within an enclosure with the ideal heat exchange organization).
Regarding claim 19, Modified Hassanein (Hassanein in view of Svitek) teaches all of the elements of the current invention as stated with respect to claim 18.
Modified Hassanein teaches:
The system of claim 18, wherein the injection system includes a cooling system configured to cool an environment of the injection system (Svitek; Paras. [0012], [0016], [0028], Fig. 2, pump/heat exchanger device (40); The cooling portion of the pump/heat exchanger is being brought into the system of Hassanein), the cooling system in communication with the controller (Hassanein; Paras. [0028], [0129-0130], [0143], [0145], heating subsystem (149), control system (100); Hassanein discloses that there is a heat exchanger in the system which is controlled showing the control system is capable of controlling a heat exchange system), the controller configured to operate the cooling system (Hassanein; Paras. [0028], [0129-0130], [0143], [0145], heating subsystem (149), control system (100), temperature sensors (120, 122, 124); Hassanein discloses that there is a heat exchanger in the system which is controlled showing the control system is capable of controlling a heat exchange system.) to maintain a desired temperature of the environment of the injection system (Intended use language. See MPEP 2114(II)).
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Hassanein (US20080017194A1) in view of Svitek (US20150150715A1) as applied to claim 19 above, and further in view of Argoudelis (US20110294108A1).
Regarding claim 20, Modified Hassanein (Hassanein in view of Svitek) teaches all of the elements of the current invention as stated with respect to claim 19.
Modified Hassanein teaches:
control valves in communication with the controller and the controller configured to operate control valves. (Hassanein; Para. [0277], transducers (132, 1032a, 1032b), controller (150); Paras. [0104], [0112], perfusion fluid oxygenation sensor (140), controller (150), gas regulator (174) which can be a solenoid valve that controls the gas flow)
Modified Hassanein does not teach:
an inlet control valve connected to the perfusate circuit at the inlet of the enclosure, the inlet control valve in communication with the controller; and an outlet control valve connected to the perfusate circuit at the outlet of the enclosure,
Argoudelis teaches:
an inlet control valve connected to the perfusate circuit at the inlet of the enclosure, and an outlet control valve connected to the perfusate circuit at the outlet of the enclosure (Argoudelis; Para. [0021], Figs. 3 and 4, perfusion pump (20), inlet line (22a), outlet line (22b), valves (24); The valves (24) are connected and the perfusate inlet and outlet and used to control the flow of perfusate in and out of the organ.)
Therefore, it would be obvious for one having ordinary skill in the art before the effective filing date of the claimed invention to combine the control valve control system and organ enclosure of Hassanein with the organ enclosure perfusate inlet and outlet as taught by Argoudelis. Both Hassanein and Argoudelis are directed to organ preservation devices. Argoudelis teaches that the valves attached to the perfusate inlet and outlet allow for control of the perfusate to the organ (Argoudelis; Para. [0021]). This involves applying a known teaching (valves and inlet and outlet) to a similar device (organ preservation device using perfusion) to yield predictable results (easier control of the organ perfusate inflow and outflow).
Claim 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hassanein (US20080017194A1) in view of Freed (US20200329699A1).
Regarding claim 22, Hassanein teaches all of the elements of the current invention as stated with respect to claim 1.
Hassanein does not teach:
a vacuum pump connected to the enclosure and configured to create a negative air pressure within the enclosure.
Freed teaches:
a vacuum pump connected to the enclosure and configured to create a negative air pressure within the enclosure (Freed; Paras. [0005] and [0064], a turbine provides the vacuum within the organ chamber).
Freed further teaches that the use of negative pressure in the organ chamber when the organ is lungs will allow for natural filling or the organ and using a turbine is beneficial due to its small footprint and energy efficiency (Freed; Paras. [0005] and [0054]).
Therefore, it would be obvious for one having ordinary skill in the art before the effective filing date of the claimed invention to modify the organ enclosure of Hassanein by including a turbine to create a negative pressure within the organ enclosure as taught by Freed. The references are analogous since, both Hassanein and Freed are directed to ex vivo organ preservation. Freed teaches that the use of negative pressure in the organ chamber when the organ is lungs will allow for natural filling or the organ and using a turbine is beneficial due to its small footprint and energy efficiency (Freed; Paras. [0005] and [0054]). This involves applying a known technique (a turbine to create a negative pressure within an organ enclosure) to a similar device (an organ enclosure without any pressure difference) to yield predictable results (negative pressure within an organ enclosure allowing for more natural function when the preserved organ is a lung).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DONAVAN L BRIDGES whose telephone number is (571)272-9636. The examiner can normally be reached Mon-Fri 8:00am-5:00pm EST.
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/D.L.B./Examiner, Art Unit 1758
/MATTHEW D KRCHA/Primary Examiner, Art Unit 1796
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