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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 11/12/2025 has been entered.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-5 and 11-15 are rejected under 35 U.S.C. 103 as being unpatentable by Kyi et al. (CA2980782A1) in view of Levner et al. (US20170058257A1).
Regarding Claim 1, Kyi teaches the following:
A portable organ care system 100 including an organ chamber assembly 104 for containing a heart (a transport container configured to receive an organ)(page 19, lines 21-24)
Perfusion fluid 108 is prepared for use in the system 100 and loaded into reservoir 160 (part of organ chamber assembly 104)(the transport container configured to be at least partially filled with preservation fluid)(page 21, lines 9-10)
A pump 106 pumps the perfusion fluid from the reservoir to the heater assembly 110, from the heater assembly the perfusion fluid flows to a mode selector valve 112 (flow regulator valve), which directs the perfusion fluid into the organ chamber assembly 104 via a first interface 162 (inlet)(a fluid circuit comprising an inlet configured to be in communication with the preservation fluid and a flow regulator valve in fluid communication with the inlet)(page 21, lines 11-21)
The system 100 includes a plurality of sensors including temperature sensors, pressure sensors, and perfusion flow rate sensors (page 20, lines 4-5). The flow regulator valve configured to regulate flow rate from the fluid circuit to the organ based on at least one organ parameter is an intended use of the device. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim (see MPEP 2114). Given the device of Kyi teaches sensors to detect temperature and flow rate, the device would be capable of regulating the flow based on those parameters and therefore meets the claim.
The perfusion fluid 108 is pumped out of the heart through the right ventricle via a second interface 166 (outlet)(an outlet in fluid communication with the flow regulator valve and the organ)(page 21, lines 24-26)
As above, a pump 106 pumps the perfusion fluid from the reservoir to the heater assembly 110, from the heater assembly the perfusion fluid flows to a mode selector valve 112, which directs the perfusion fluid into the organ chamber assembly 104 via a first interface 162 (inlet)(a pump configured to pump the preservation fluid from the inlet to the organ)(page 21, lines 11-21). The pump configured to operate independently of the at least one organ parameter is an intended use of the invention. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim (see MPEP 2114). The pump in the device of Kyi would be capable of operating independently of at least one organ parameter and therefore meets the claim.
Kyi does not teach the flow regulator valve to comprise a mechanically actuated valve configured to shift between the first configuration and second configuration by the preservation fluid flowing in the fluid circuit.
Levner teaches a culture module that allow perfusion and a method for pressure control of flow rate while perfusing cells (Abstract). Levner further teaches a pressure manifold including one or more valves adapted to controllably shut off one or more of the fluidic conduits and a variety of suitable valves are known in the art such as ball valves and spring-loaded valves (mechanically actuated valves)(para 191). Note: Applicant’s specification paragraph 156 states the flow regulator valve can include a ball and spring. Levner further teaches the valves can be controlled by sensing whether a fluidic element is present and such sensing can involve mechanical means (para 191).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the mode selector valve of Kyi with the spring-loaded valve as taught by Levner. One would have been motivated to make this modification as Levner teaches the spring-loaded valve to one of a variety of valves known in the art suitable for controlling the flow through fluidic conduits (para 191) and substituting equivalents known for the same purpose is prima facie obvious. See MPEP 2144.06(II).
Further, the flow regulator valve configured to shift between a first configuration and a second configuration in direct response to the pressure within the fluid circuit, the first configuration to increase flow rate and the second configuration to decrease flow rate is an intended use of the device. Since the device of Kyi in view of Levner would be capable of shifting between multiple configurations using the spring loaded valve, it meets the claim.
Regarding Claim 2, Kyi in view of Levner teaches all of the limitations of Claim 1 (see above). The at least one organ parameter being vessel resistance, organ temperature, or flow rate is an intended use of the device. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim (see MPEP 2114). Kyi further teaching the system 100 to includes a plurality of sensors including temperature sensors, pressure sensors, and perfusion flow rate sensors (page 20, lines 4-5) means the at least one organ parameter in which the flow regulator valve regulates flow is based on is capable of being organ temperature, vessel resistance, or flow rate and therefore meets the claim.
Regarding Claim 3, Kyi in view of Levner teaches all of the limitations of Claim 1 (see above). Kyi further teaches the organ chamber assembly includes a pad 222 and preferably from a material resilient enough to cushion the heart (an organ rest configured to support the organ)(page 27, lines 5-7).
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Regarding Claim 4, Kyi in view of Levner teaches all of the limitations of Claim 3 (see above). Kyi further teaches the heart is harvested and cannulated into the organ chamber assembly (page 21, lines 8-9) and cannulation can be formed by inserting directly in to the left atrium and clamping (barb) the device (page 22, lines 22-24). This means there is a cannula (or organ adapter) which seals the vessels of the organ. The cannula would in some capacity be adjustable along the groove which the organ rest creates between the organ and the organ rest (see Fig. 5E, above).
Regarding Claim 5, Kyi in view of Levner teaches all of the limitations of Claim 1 (see above). Kyi further teaches system 100 also includes a plurality of compliance chambers (pressure dampeners) which provide flow back-pressure and/or by filtering/reducing fluid pressure spikes due to flow rate changes and/or the pumping of the pump (a pressure dampener configured to reduce pulsation in the fluid circuit caused by the pump)(page 24, lines 7-13).
Regarding Claim 11, Kyi teaches the following:
A portable organ care system 100 including an organ chamber assembly 104 for containing a heart (a transport container configured to receive an organ)(page 19, lines 21-24)
Perfusion fluid 108 is prepared for use in the system 100 and loaded into reservoir 160 (part of organ chamber assembly 104)(the transport container configured to be at least partially filled with preservation fluid)(page 21, lines 9-10)
A pump 106 pumps the perfusion fluid from the reservoir to the heater assembly 110, from the heater assembly the perfusion fluid flows to a mode selector valve 112, which directs the perfusion fluid into the organ chamber assembly 104 via a first interface 162 (inlet)(a pump configured to pump the preservation fluid from transport container to the organ in a fluid circuit)(page 21, lines 11-21). The pump configured to operate independently of the vessel resistance is an intended use of the invention. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim (see MPEP 2114). The pump in the device of Kyi would be capable of operating independently of the vessel resistance and therefore meets the claim.
As above, a pump 106 pumps the perfusion fluid from the reservoir to the heater assembly 110, from the heater assembly the perfusion fluid flows to a mode selector valve 112 (flow regulator valve), which directs the perfusion fluid into the organ chamber assembly 104 via a first interface 162 (inlet)(a flow regulator valve in fluid communication with the fluid circuit)(page 21, lines 11-21)
The system 100 includes a plurality of sensors including temperature sensors, pressure sensors, and perfusion flow rate sensors (page 20, lines 4-5). The flow regulator valve configured to regulate flow rate from the fluid circuit to the organ based on at least one organ parameter is an intended use of the device. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim (see MPEP 2114). Given the device of Kyi teaches sensors to detect temperature and flow rate, the device would be capable of regulating the flow based on those parameters and therefore meets the claim.
Kyi does not teach the flow regulator valve to comprise a mechanically actuated valve configured to shift between the first configuration and second configuration by the preservation fluid flowing in the fluid circuit.
Levner teaches a culture module that allow perfusion and a method for pressure control of flow rate while perfusing cells (Abstract). Levner further teaches a pressure manifold including one or more valves adapted to controllably shut off one or more of the fluidic conduits and a variety of suitable valves are known in the art such as ball valves and spring-loaded valves (mechanically actuated valves)(para 191). Note: Applicant’s specification paragraph 156 states the flow regulator valve can include a ball and spring. Levner further teaches the valves can be controlled by sensing whether a fluidic element is present and such sensing can involve mechanical means (para 191).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the mode selector valve of Kyi with the spring-loaded valve as taught by Levner. One would have been motivated to make this modification as Levner teaches the spring-loaded valve to one of a variety of valves known in the art suitable for controlling the flow through fluidic conduits (para 191) and substituting equivalents known for the same purpose is prima facie obvious. See MPEP 2144.06(II).
Further, the flow regulator valve configured to shift between a first configuration and a second configuration in direct response to the pressure within the fluid circuit, the first configuration to increase flow rate and the second configuration to decrease flow rate is an intended use of the device. Since the device of Kyi in view of Levner would be capable of shifting between multiple configurations using the spring loaded valve, it meets the claim.
Regarding Claim 12, Kyi in view of Levner teaches all of the limitations of Claim 11 (see above). The at least one organ parameter being vessel resistance, organ temperature, or flow rate is an intended use of the device. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim (see MPEP 2114). Kyi further teaching the system 100 to includes a plurality of sensors including temperature sensors, pressure sensors, and perfusion flow rate sensors (page 20, lines 4-5) means the at least one organ parameter in which the flow regulator valve regulates flow is based on is capable of being organ temperature, vessel resistance, or flow rate and therefore meets the claim.
Regarding Claim 13, Kyi in view of Levner teaches all of the limitations of Claim 11 (see above). Kyi further teaches the organ chamber assembly includes a pad 222 and preferably from a material resilient enough to cushion the heart (an organ rest configured to support the organ)(page 27, lines 5-7).
Regarding Claim 14, Kyi in view of Levner teaches all of the limitations of Claim 13 (see above). Kyi further teaches the heart is harvested and cannulated into the organ chamber assembly (page 21, lines 8-9) and cannulation can be formed by inserting directly in to the left atrium and clamping (barb) the device (page 22, lines 22-24). This means there is a cannula (or organ adapter) which seals the vessels of the organ. The cannula would in some capacity be adjustable along the groove which the organ rest creates between the organ and the organ rest (see Fig. 5E, below).
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Regarding Claim 15, Kyi in view of Levner teaches all of the limitations of Claim 11 (see above). Kyi further teaches system 100 also includes a plurality of compliance chambers (pressure dampeners) which provide flow back-pressure and/or by filtering/reducing fluid pressure spikes due to flow rate changes and/or the pumping of the pump (a pressure dampener configured to reduce pulsation in the fluid circuit caused by the pump)(page 24, lines 7-13).
Claim 6 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Kyi et al. (CA2980782A1) in view of Levner et al. (US20170058257A1) and further in view of Steen et al. (CA2775327A1).
Regarding Claim 6, Kyi in view of Levner teaches all of the limitations of Claim 1 (see above). Kyi in view of Levner does not teach the pump to be a peristaltic pump.
Steen teaches an organ container comprising an organ immersed in fluid, an inlet tube, an outlet tube, a heater, an oxygenator, a pump, and valves (page 11, lines 29-34). Steen further teaches the pump may be a conventional peristaltic pump or any other type of pump (page 12, lines 31-32).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Kyi in view of Levner with a peristaltic pump as taught by Steen. One would have been motivated to make this modification as Steen teaches the peristaltic pump to be a viable option for use in organ containers and it would have resulted in an effective pump for the pumping of perfusion fluid in the device of Kyi in view of Levner. See also MPEP 2144.06(II).
Regarding Claim 16, Kyi in view of Levner teaches all of the limitations of Claim 11 (see above). Kyi in view of Levner does not teach the pump to be a peristaltic pump.
Steen teaches an organ container comprising an organ immersed in fluid, an inlet tube, an outlet tube, a heater, an oxygenator, a pump, and valves (page 11, lines 29-34). Steen further teaches the pump may be a conventional peristaltic pump or any other type of pump (page 12, lines 31-32).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Kyi in view of Levner with a peristaltic pump as taught by Steen. One would have been motivated to make this modification as Steen teaches the peristaltic pump to be a viable option for use in organ containers and it would have resulted in an effective pump for the pumping of perfusion fluid in the device of Kyi in view of Levner. See also MPEP 2144.06(II).
Claim 7 and 17 is rejected under 35 U.S.C. 103 as being unpatentable over Kyi et al. (CA2980782A1) in view of Levner et al. (US20170058257A1) and further in view of Steinman et al. (CN104619169A).
Regarding Claim 7, Kyi in view of Levner teaches all of the limitations of Claim 1 (see above). Kyi in view of Levner does not teach the container to comprise a plurality of posts and an organ retainer adjustably couplable to the plurality of posts.
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Steinman teaches an apparatus for holding on organ for transport (para 21). Steinman further teaches the peripheral ridge of the organ container may include a plurality of slits through which a plurality of straps (organ retainer) may be disposed, and a plurality of notches configured with protrusions (plurality of posts) for securing the plurality of straps (para 59 and Fig. 7, below). Further, the straps are adjustably couplable to the posts as they can be removed to allow the organ to be removed from the container.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Kyi in view of Levner with the straps and protrusions as taught by Steinman. One would have been motivated to make this modification as it would hold the organ in place during transport (para 59).
Regarding Claim 17, Kyi in view of Levner teaches all of the limitations of Claim 11 (see above). Kyi in view of Levner does not teach the container to comprise a plurality of posts and an organ retainer adjustably couplable to the plurality of posts.
Steinman teaches an apparatus for holding on organ for transport (para 21). Steinman further teaches the peripheral ridge of the organ container may include a plurality of slits through which a plurality of straps (organ retainer) may be disposed, and a plurality of notches configured with protrusions (plurality of posts) for securing the plurality of straps (para 59 and Fig. 7, above). Further, the straps are adjustably couplable to the posts as they can be removed to allow the organ to be removed from the container.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Kyi in view of Levner with the straps and protrusions as taught by Steinman. One would have been motivated to make this modification as it would hold the organ in place during transport (para 59).
Claims 8 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Kyi et al. (CA2980782A1) in view of Levner et al. (US20170058257A1) and further in view of Fishman et al. (US20090197325A1, in IDS filed 01/30/2025).
Regarding Claim 8, Kyi in view of Levner teaches all of the limitations of Claim 1 (see above). Kyi in view of Levner does not teach a one-way valve in fluid communication with the fluid circuit configured to take in preservation fluid from the transport container when fluid is drawn out of the fluid circuit.
Fishman teaches an organ care system which circulates perfusion fluid (para 57). Fishman further teaches the perfusion module 400 includes a relief valve (one-way valve) which provides for controlled release of gas to be expelled to the outside (takes in the fluid from the transport container when fluid is drawn out of the circuit)(para 71).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Kyi in view of Levner with the relief valve as taught by Fishman. One would have been motivated to make this modification as it would reduce pressure within the loop (para 71).
Regarding Claim 18, Kyi in view of Levner teaches all of the limitations of Claim 11 (see above). Kyi in view of Levner does not teach a one-way valve in fluid communication with the fluid circuit configured to take in preservation fluid from the transport container when fluid is drawn out of the fluid circuit.
Fishman teaches an organ care system which circulates perfusion fluid (para 57). Fishman further teaches the perfusion module 400 includes a relief valve (one-way valve) which provides for controlled release of gas to be expelled to the outside (takes in the fluid from the transport container when fluid is drawn out of the circuit)(para 71).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Kyi in view of Levner with the relief valve as taught by Fishman. One would have been motivated to make this modification as it would reduce pressure within the loop (para 71).
Claims 9, 19, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Kyi et al. (CA2980782A1) in view of Levner et al. (US20170058257A1) and further in view of Anderson et al. (CA3149024A1).
Regarding Claim 9, Kyi in view of Levner teaches all of the limitations of Claim 1 (see above). Kyi in view of Levner does not teach an accumulation chamber configured to seal a port on a lid of the transport container, the accumulation chamber comprising a balloon configured to expand when the preservation fluid expands and contract when the preservation fluid contracts.
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Anderson teaches systems for prolonging viability of bodily tissue through use of sealed organ transport system filled with preservation fluid (Abstract). Anderson further teaches an in-line pressurizer using an elastomeric balloon (accumulation chamber) which seals to a port on the lid of the organ chamber and inflates during the filling process (expands and contracts based on the preservation fluid)(page 8, para 2, and Fig. 6A and 6B, below)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Kyi in view of Levner with the elastomeric balloon pressurizer as taught by Anderson. One would have been motivated to make this modification as it would help achieve and maintain the desired pressure within the system (page 5, lines 5-7).
Regarding Claims 19 and 20, Kyi in view of Levner teaches all of the limitations of Claim 11 (see above). Kyi in view of Levner does not explicitly teach a lid comprising a fill port and a vent port. Anderson teaches the organ container to comprise a vent port and a fill port (Claim 1) and an in-line pressurizer using an elastomeric balloon (accumulation chamber) which seals to a port on the lid of the organ chamber and inflates during the filling process (expands and contracts based on the preservation fluid)(page 8, para 2, and Fig. 6A and 6B, above)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Kyi in view of Levner with the ports on the lid and the elastomeric balloon pressurizer as taught by Anderson. One would have been motivated to make this modification as it would help achieve and maintain the desired pressure within the system (page 5, lines 5-7).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Kyi et al. (CA2980782A1) in in view of Levner et al. (US20170058257A1) and further view of Fahy (WO1996030111A1).
Kyi in view of Levner teaches all of the limitations of Claim 1 (see above). Kyi in view of Levner does not teach the system to include a bubble trap integrated in the fluid circuit.
Fahy teaches an organ storage device for static storage and perfusion without removing the organ (Abstract). Fahy further teaches the perfusion tube contains a bubble trap 111 (page 9, line 14).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Kyi in view of Levner with the bubble trap as taught by Fahy.
One would have been motivated to make this modification as it prevents bubbles from entering the organ through the perfusion tube (page 9, lines 30-32).
Response to Arguments
Applicant's arguments filed 11/12/2025 have been fully considered. Applicant’s arguments are directed toward the newly amended claims which have been address above with newly cited Levner et al. (US20170058257A1). This reference replaces Kay due to amendments to the claims.
Conclusion
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/J.E.L./Examiner, Art Unit 1796
/ELIZABETH A ROBINSON/Supervisory Patent Examiner, Art Unit 1796