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 .
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, 2, 4, 5, 7-12, 16, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Faulkner et al. (US20120116152A1) in view of Church et al. (WO2019133929A1).
Regarding Claim 1, Faulkner teaches the following:
A perfusion system including a means for circulating fluid such as a pump (para 25)(a system comprising a pump configured to generate a flow of fluid)
An organ enclosure 24 which provides physical protection and isolates it from the external environment (para 28)(a container defining an interior cavity configured to receive at least one organ and maintain at least one environmental condition associated with the at least one organ within the cavity)
A fluid circuit defined by plastic tubing or another suitable type of conduit connected to an organ by an inlet line 14 and an outlet line 16 (para 24)(a fluid circuit configured to fluidically couple the pump to the at least one organ or tissue)
A lower support pad 26 within the enclosure 24 (platform operably coupled to the container)
Faulkner does not teach at least one actuator coupled to the platform via an assembly arm, wherein the at least one actuator is configured to move the platform in one or more dimensions via the assembly arm to mimic at least one biological movement associated with the at least one organ or tissue.
Church teaches a treatment system for biological fluids with a chamber and platform (para 118). Church further teaches the platform may be slidable movable in a drawer configuration by any suitable actuator (which would require an arm attached to the platform), such as an electric motor or servo (para 118) and the translation of the platform may be effected by any number of actuators (para 150).
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 Faulkner with the actuator as taught by Church. One would have been motivated to make this modification as Church teaches it to be an effective method for the movement of a platform within the chamber.
Further, the actuator configured to move the platform in one or more dimensions via the assembly arm to mimic at least one biological movement associated with the at least one organ or tissue 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 actuator is capable of moving the platform in one or more dimensions, it would be capable of mimicking a biological movement of the organ or tissue.
Regarding Claim 2, Faulkner in view of Church teaches all of the limitations of Claim 1 (see above). Faulkner further teaches the pump to comprise a pump outlet and the fluid circuit comprises an inlet line which couples to the pump outlet and the container comprises an inlet which allows passage of the inlet line into the interior of the cavity to couple to the organ (para 24 and Fig. 1, below).
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Regarding Claim 4, Faulkner in view of Church teaches all of the limitations of Claim 1 (see above). Faulkner further teaches an electronic controller to be used to control the operation of the perfusion system (e.g. control the pump)(para 25)(control circuitry configured to control the pump). Church further teaches the actuators are controlled by control circuitry which increases or decreases the distance between any pair of platforms (para 150)(control circuitry which controls the at least one actuator to move the platform via the assembly arm along a predetermined path at a specific distance).
Regarding Claim 5, Faulkner in view of Church teaches all of the limitations of Claim 1 (see above). Faulkner further teaches the lower support pad (platform) is within the organ enclosure 24 (interior cavity of the container) and the lower support pad 26 rests on the floor 32 (of the organ enclosure)(the container mechanically supports the platform) and the organ rests on top of the lower supports pad 26 (the platform mechanically supports the at least one organ or tissue (para 29 and Fig. 3, below).
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Regarding Claim 7, Faulkner in view of Church teaches all of the limitations of Claim 1 (see above). Faulkner further teaches a pass through opening for making a connection to the ureter to allow urine to drain (para 28)(access port to allow insertion of a medical device into the interior cavity).
Regarding Claim 8, Faulkner in view of Church teaches all of the limitations of Claim 7 (see above). Faulkner further teaches the front wall 36 is provided with pass-through openings for making connections (para 28). The access port facilitating simulation of at least one of femoral access or radial access to the at least one organ or tissue 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 pass-through openings are located on the front wall for making connections, the system of Faulkner would be capable of simulating femoral or radial access and therefore meets the claim.
Regarding Claim 9, Faulkner in view of Church teaches all of the limitations of Claim 1 (see above). Faulkner further teaches the enclosure isolates the organ form an external environment (para 28). This means the enclosure would be maintaining the humidity and fluid level of the fluid in the cavity.
Regarding Claims 10-12, Faulkner in view of Church teaches all of the limitations of Claim 1 (see above). The limitations of Claims 10-12 are directed to the material worked upon by the apparatus, all the structural limitations of the claim has been disclosed by Faulkner and the apparatus of Faulkner is capable of working on the fluid that is transparent, comprised of sodium, potassium, chloride, calcium, magnesium sulfate, bicarbonate, phosphate, and glucose, or blood. As such, it is deemed that the claimed apparatus is not differentiated from the apparatus of Faulkner (see MPEP §2115). Note: the fluid is not a positively recited component of the system.
Regarding Claim 16, Faulkner in view of Church teaches all of the limitations of Claim 1 (see above). Faulkner further teaches an image device may be used to observe the organ (para 27)(at least one image sensor configured to collect image data of the at least one organ or tissue).
Regarding Claim 20, Faulkner teaches the following:
A perfusion system including a means for circulating fluid such as a pump (para 25)(a system comprising a pump configured to generate a flow of fluid)
An organ enclosure 24 which provides physical protection and isolates it from the external environment (para 28)(a container defining an interior cavity configured to receive at least one organ and maintain at least one environmental condition associated with the at least one organ within the cavity)
A fluid circuit defined by plastic tubing or another suitable type of conduit connected to an organ by an inlet line 14 and an outlet line 16 (para 24)(a fluid circuit configured to fluidically couple the pump to the at least one organ or tissue)
An image device may be used to observe the organ (para 27)(at least one image sensor configured to collect image data of the at least one organ or tissue).
A lower support pad 26 within the enclosure 24 (platform operably coupled to the container)
Faulkner does not teach at least one actuator coupled to the platform via an assembly arm, wherein the at least one actuator is configured to move the platform in one or more dimensions via the assembly arm to mimic at least one biological movement associated with the at least one organ or tissue.
Church teaches a treatment system for biological fluids with a chamber and platform (para 118). Church further teaches the platform may be slidable movable in a drawer configuration by any suitable actuator (which would require an arm attached to the platform), such as an electric motor or servo (para 118) and the translation of the platform may be effected by any number of actuators (para 150).
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 Faulkner with the actuator as taught by Church. One would have been motivated to make this modification as Church teaches it to be an effective method for the movement of a platform within the chamber.
Further, the actuator configured to move the platform in one or more dimensions via the assembly arm to mimic at least one biological movement associated with the at least one organ or tissue 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 actuator is capable of moving the platform in one or more dimensions, it would be capable of mimicking a biological movement of the organ or tissue.
Claims 1, 6, and 13-14 are rejected under 35 U.S.C. 103 as being unpatentable over Messer et al. (GB2587350A) in view of Church et al. (WO2019133929A1).
Regarding Claim 1, Messer teaches the following:
A heart perfusion system comprising an organ chamber (container defining an interior cavity configured to receive at least one organ or tissue) and a first fluid flow path comprising a pump interface (page 2, lines 19-20)(a system comprising a pump configured to generate a flow of fluid). Given the organ container is a closed organ container, it would maintain at least one environmental condition associated with the at least one organ.
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A fluid flow path 19 (fluid circuit) fluidically coupling the pump 23 to the organ (see Fig.2, below)
An organ chamber support member 53 is rotatable relative to the chassis disposed on platform 55 (page 14, line 9)(a platform operably connected to the container)
The platform is rotatable in a horizontal plane (indicating the presence of an actuator which moves the platform).
Messer does not explicitly teach at least one actuator coupled to the platform via an assembly arm, wherein the at least one actuator is configured to move the platform in one or more dimensions via the assembly arm to mimic at least one biological movement associated with the at least one organ or tissue.
Church teaches a treatment system for biological fluids with a chamber and platform (para 118). Church further teaches the platform may be slidable movable in a drawer configuration by any suitable actuator (which would require an arm attached to the platform), such as an electric motor or servo (para 118) and the translation of the platform may be effected by any number of actuators (para 150).
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 Messer with the actuator as taught by Church. One would have been motivated to make this modification as Church teaches it to be an effective method for the movement of a platform within the chamber.
Further, the actuator configured to move the platform in one or more dimensions via the assembly arm to mimic at least one biological movement associated with the at least one organ or tissue 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 actuator is capable of moving the platform in one or more dimensions, it would be capable of mimicking a biological movement of the organ or tissue.
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Regarding Claim 6, Messer in view of Church teaches all of the limitations of Claim 1 (see above). Messer further teaches the platform to be positioned underneath the container and configured to mechanically support the container (see Fig. 9, below).
Regarding Claims 13 and 14, Messer in view of Church teaches all of the limitations of Claim 1 (see above). Messer further teaches a monitor which is configured to display output information of one or more sensors of the heart perfusion system such as oxygen saturation sensors, pressure sensors, temperature sensors, or flow rate sensors (page 13, lines 30-35)(the system comprises at least one physiological sensor configured to measure at least one physiological condition which includes pressure of a fluid, flow rate, etc.).
Claims 3 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Messer et al. (GB2587350A) in view of Church et al. (WO2019133929A1) and further in view of Iaizzo et al. (US20140370490A1).
Regarding Claim 3, Messer in view of Church teaches all of the limitations of Claim 1 (see above). Messer in view of Church does not teach a pressure column configured to adjust the pressure of fluid within the at least one organ.
Iaizzo teaches an isolated heart in which normal pumping of all four chambers of the heart is preserved (Abstract). Iaizzo further teaches a preload chamber 210 (pressure column) which comprises a fluid column adjusted to maintain approximately 5 mmHg pressure going into the right atrium (para 30).
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 Messer in view of Church with the preload chamber as taught by Iaizzo. One would have been motivated to make this modification as it allows the delivering of perfusate at appropriate physiological pressures (para 25).
Regarding Claim 15, Messer in view of Church teaches all of the limitations of Claim 1 (see above). Messer in view of Church does not teach the system to include an electrode positioned in the interior of the cavity to deliver electrical signal to the organ.
Iaizzo teaches electrodes on the surface of the left ventricle (interior of the cavity) to deliver a defibrillation shock (deliver electrical signals)(para 27).
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 Messer in view of Church with the electrodes as taught by Iaizzo. One would have been motivated to make this modification as it would enable moderation and control of the heart rhythm as necessary (para 27).
Response to Arguments
Applicant's arguments filed 04/03/2026 have been fully considered but they are not persuasive.
Applicant’s arguments are directed towards newly amended claims and have been addressed above with the combinations of previously cited prior art and the addition of Church et al. (WO2019133929A1).
Conclusion
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JONATHAN E LEPAGE whose telephone number is (571)270-3971. The examiner can normally be reached 8:30-5:30 ET.
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/J.E.L./Examiner, Art Unit 1796
/MICHAEL A MARCHESCHI/Supervisory Patent Examiner, Art Unit 1799
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