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 Objections
Claim 1 is objected to because of the following informalities: claim 1 recites “a pump disposed within the enclosure configured to cause flow in the line” whereas the claim previously introduces “a fluid line.” It is therefore unclear whether “the line” refers to the previously-recited fluid line or to some other line, (e.g., an air line). For clarity and consistency with the specification, applicant is advised to amend “the line” in claim 1 to read “the fluid line”.
Claim 2 is objected to because of the following informalities: claim 2 recites “a wireless control module connected to control module” and should likely read “a wireless control module connected to the control module” to provide proper antecedent basis for the control module in claim 2.
Claims 19 and 20 are objected to because of the following informalities: claims 19 and 20 each recite “The non-transitory computer readable of claim [18/19]…” omitting the word “medium” after “computer readable“ such that the antecedent “non-transitory computer readable medium” in claim 17 is not properly carried through and the claimed subject is unclear. For clarity and consistency with claim 17 and the specification, applicant is advised to amend “The non-transitory computer readable of claim [18/19]” in claims 19 and 20 to read “The non-transitory computer readable medium of claim [18/19].”
Appropriate correction is required.
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 1-4, 6-11, and 13-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Freed (US Publication No. 2017/0339945), hereinafter Freed.
Regarding claim 1, Freed discloses:
an organ procurement perfusion pump system (apparatus 1000 in fig. 1, para [0040]), comprising:
a portable enclosure (base unit 1001 in fig. 1, para [0040], Lines 2-4 and base unit 1002 in figs. 2-4, para [0051]);
a fluid line (conduit series (122, 132, 138, 142,148) or conduit series (122, 132,138, 150) or conduit series (124, 162, 170, 178) or conduit series (124, 162, 180, 188) or conduit series (190, 196) in figs. 2-4, para [0055]);
a pump (pumps 130 and 160 in figs. 2-4) disposed within the enclosure (base unit 1002 in figs. 2-4) configured to cause flow in the line (para [0043]);
one or more sensors (flow sensors 144, 174, 186, 194 in figs. 2-4) disposed in functional communication with the fluid line (conduit series (122, 132, 138, 142,148) with flow sensor 144; or (124, 162, 170, 178) with flow sensor 174; or (124, 162, 180, 188) with flow sensor 182; or (190, 196) with flow sensor 194 in figs. 2-4, para [0063, 0067-0071]);
a thermal control cavity (reservoir 120 in figs. 2-4) within the enclosure (base unit 1002 in figs. 2-4) configured to contain one or more perfusate containers which connect to the fluid line (conduit series (122, 132, 138, 142,148) or conduit series (122, 132,138, 150) or conduit series (124, 162, 170, 178) or conduit series (124, 162, 180, 188) or conduit series (190, 196) in figs. 2-4) to regulate the temperature of the perfusate (para [0067, 0107]; reservoir 120 is connected to heat exchanger 134 and thus is ‘configured to’ regulate temperature); and
a control module (controller 110 in figs. 2-4) operatively connected to the pump (pumps 130 and 160 in figs. 2-4) and the one or more sensors (flow sensors 144, 174, 186, 194 in figs. 2-4), and configured to control the pump (para [0060]).
Regarding claim 2, Freed discloses the system of claim 1 (apparatus 1000 in fig. 1), further comprising a wireless communication module (I/O interface 604 in fig. 9) connected to control module (controller 110 in figs. 2-4) to allow communication with a mobile device (para [0060, 0113-0114]).
Regarding claim 3, Freed discloses the system of claim 1 (apparatus 1000 in fig. 1), wherein the control module (controller 110 in figs. 2-4) is configured to output data to a mobile device (computing device 600 in fig. 9), and/or to receive commands from the mobile device to control the pump (para [0108]).
Regarding claim 4, Freed discloses the system of claim 3 (apparatus 1000 in fig. 1), wherein the control module (controller 110 in figs. 2-4) is configured to automatically control the pump (pumps 130 and 160 in figs. 2-4) as a function of output (para [0060]) from the one or more sensors (flow sensors 144, 174, 186, 194 in figs. 2-4) to maintain perfusate parameters within one or more thresholds (para [0085]).
Regarding claim 6, Freed discloses the system of claim 4 (apparatus 1000 in fig. 1), wherein the system includes an active cooling system (heat exchanger 134 in figs. 2-4) in thermal communication with the thermal control cavity (reservoir 120 in figs. 2-4, Para [0067]) configured to regulate the temperature of the perfusate (para [0057]).
Regarding claim 7, Freed discloses the system of claim 6 (apparatus 1000 in fig. 1), further comprising an energy supply configured to power the active cooling system (heat exchanger 134 in figs. 2-4, para [0057]).
Regarding claim 8, Freed discloses the system of claim 7 (apparatus 1000 in fig. 1), wherein the control module (controller 110 in figs. 2-4) is configured to control the active cooling system (heat exchanger 134 in figs. 2-4) to control a temperature of the perfusate based on one or more temperature signals (para [0060, 0107]; controller 110 in communication with heat exchanger 134 and feedback control of perfusate source via measured temperature in perfusion modules 112.).
Regarding claim 9, Freed discloses the system of claim 1 (apparatus 1000 in fig. 1), wherein the one or more sensors (flow sensors 144, 174, 186, 194 in figs. 2-4) include a flow meter (flow sensors 144, 174, 186, 194 in figs. 2-4) configured to read a flow in the fluid line (conduit series (122, 132, 138, 142,148) with flow sensor 144; or conduit series (124, 162, 170, 178) with flow sensor 174; or conduit series (124, 162, 180, 188) with flow sensor 182; or conduit series (190, 196) with flow sensor 194 in figs. 2-4), a pressure sensor (pressure sensors 147, 177, 186, 193 in figs. 2-4) configured to read a pressure in the fluid line (conduit series (122, 132, 138, 142,148) with pressure sensor 147; or conduit series (124, 162, 170, 178) with pressure sensor 177; or conduit series (124, 162, 180, 188) with pressure sensor 186; or conduit series (190, 196) with pressure sensor 193 in figs. 2-4), and a temperature sensor configured to read temperature of the perfusate in the fluid line (para [0059], temperature sensors give feedback of perfusate temperature to controller 110).
Regarding claim 10, Freed discloses the system of claim 9 (apparatus 1000 in fig. 1), further comprising an air filter (purge line 150 in figs. 2-4) configured to remove air from the fluid line (conduit series (122, 132, 138, 142,148) or conduit series (122, 132,138, 150) or (124, 162, 170, 178) or conduit series (124, 162, 180, 188) or conduit series (190, 196) in figs. 2-4) upstream of the one or more fluid sensors (fig. 4, para [0068]).
Regarding claim 11, Freed discloses the system of claim 10 (apparatus 1000 in fig. 1), wherein the one or more fluid sensors (flow sensors 144, 174, 186, 194 in figs. 2-4) are downstream of the pump (pumps 130 in fig. 4, para [0068], flow sensor 144 is downstream of pump 130).
Regarding claim 13, Freed discloses a method, comprising: actively controlling a pressure and/or flow of perfusate to an organ of a donor during organ procurement (paras [0006, 0042]).
Regarding claim 14, Freed discloses the method of claim 13, further comprising controlling temperature of the perfusate during organ procurement (para [0107]).
Regarding claim 15, Freed discloses the method of claim 13, wherein actively controlling includes using a portable (para [0003], for transportation of harvested organs) perfusate pump system (fluid subsystem 100 in fig. 1, para [0043], contains centrifugal pumps 130 and 160).
Regarding claim 16, Freed discloses the method of claim 15, wherein actively controlling includes using a mobile device (computing device 600 in fig. 9) connected to the portable perfusate pump system (fluid subsystem 100 in fig. 1, para [0043], para [0108]).
Regarding claim 17, Freed discloses:
a non-transitory computer readable medium (memory 606 in fig. 9) comprising computer executable instructions configured to cause a computer (processors 602 in fig. 9) to perform a method (para [0116]), the method comprising:
actively controlling a pressure and/or flow of perfusate to an organ of a donor during organ procurement as a function of feedback (para [0077]) from one or more pressure sensors and/or flow sensors (flow sensors 144, 174, 186, 194 and pressure sensors 147, 177, 186, 193 in figs. 2-4).
Regarding claim 18, Freed discloses the non-transitory computer readable medium of claim 17 (memory 606 in fig. 9), wherein the method further comprises controlling temperature of the perfusate during organ procurement as a function of temperature feedback (para [0060, 0046, 0107]) from one or more temperature sensors (para [0059]).
Regarding claim 19, Freed discloses the non-transitory computer readable of claim 18 (memory 606 in fig. 9), wherein actively controlling includes controlling a portable (para [0003], for transportation of harvested organs) perfusate pump system (fluid subsystem 100 in fig. 1, para [0043], contains centrifugal pumps 130 and 160).
Regarding claim 20, Freed discloses the non-transitory computer readable of claim 19 (memory 606 in fig. 9), wherein actively controlling includes receiving inputs from a mobile device (para [0107-0108]; portable computing devices such as mobile phone, netbook, laptop, personal data assistant (PDA), or tablet) connected to the portable (para [0003], for transportation of harvested organs) perfusate pump system (fluid subsystem 100 in fig. 1, para [0043], contains centrifugal pumps 130 and 160) to control the portable perfusate pump system.
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.
Claims 5 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Freed in view of Gharb (US Publication No. 2021/0289771), hereinafter Gharb.
Regarding claim 5, Freed discloses the system of claim 4 (apparatus 1000 in fig. 1) with a thermal control cavity (reservoir 120 in figs. 2-4), but Freed fails to disclose wherein the cavity is configured to contain and/or insulate passive temperature regulation media.
Gharb teaches a thermal control cavity (perfusion core 16 in fig. 3) that is configured to contain and/or insulate passive temperature regulation media (Gharb, para [0043], cooled via ice and/or a nitrogen gas mixture).
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 thermal control cavity of Freed to be able to contain and/or insulate passive temperature regulation media such as ice and/or a nitrogen gas mixture, as taught by Gharb, in order to maintain consistent perfusate temperature control in a simple, reliable, and portable manner during organ procurement.
Regarding claim 12, Freed discloses the system of claim 11 (apparatus 1000 in fig. 1), but Freed fails to disclose the system further comprising a manifold upstream of the pump configured to connect to a plurality of perfusate containers.
Gharb teaches a manifold (fig. 3 and fig. 4, para [0042-0043]; the multi-container arrangement of perfusate reservoirs 30, 32, and 34, connected to the at least one conduit 18) upstream of the pump (pump 46 in fig. 3) configured to connect to a plurality of perfusate containers (first perfusate reservoir 30, second perfusate reservoir 32, and third perfusate reservoir 34 in fig. 3).
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 organ procurement perfusion pump system of Freed to include a manifold upstream of the pump configured to connect to a plurality of perfusate containers, as taught by Gharb, in order to facilitate the use of multiple perfusate reservoirs and improve flexibility in solution selection and exchange during perfusion.
Conclusion
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/ZACHARIAH K WHITROCK/Patent Examiner, Art Unit 3783
/MICHAEL J TSAI/Supervisory Patent Examiner, Art Unit 3783