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 .
Information Disclosure Statement
The information disclosure statement(s) (IDS) were submitted on:
04/18/2024
03/20/2025
Accordingly, the information disclosure statement(s) are being considered by the examiner.
Specification
The disclosure is objected to because of the following informalities:
Regarding paragraph [0076], in line 2, the term “unit” is referred to twice.
Regarding paragraph [0080], in line 2, the term “Prothombin time” should be amended to “Prothrombin time”.
Regarding paragraph [0085], in line 6, the last word on the line “a” should be “an”.
Regarding paragraph [00100], in line 1, the term “undefined” exists in the specification.
Regarding paragraph [00102], in line 1, the term “undefined” exists in the specification.
Appropriate correction is required.
Claim Objections
Claims 1-2, 7-8, and 14 are objected to because of the following informalities:
Regarding claim 1, in line 2, the term “the patient” should be “a patient”.
Regarding claim 1, in line 6, the term “the primary blood circuit” should be “the primary circuit”.
Regarding claim 2, in line 2, the term “, the bypass circuit” appears to be repetitive and can be omitted.
Regarding claim 7, in line 2, the term “the inlet oxygen signal” should be “the inlet dissolved oxygen signal”.
Regarding claim 7, in line 2, the term “the outlet oxygen signal” should be “the outlet dissolved oxygen signal”.
Regarding claim 8, in line 2, the term “the inlet oxygen signal” should be “the inlet dissolved oxygen signal”.
Regarding claim 8, in lines 2-3, the term “the outlet oxygen signal” should be “the outlet dissolved oxygen signal”.
Regarding claim 14, in lines 3-4, the term “to deliver supplements” should be “to deliver each supplement”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites the limitation “a secondary sensor” and “a secondary sensor signal” in lines 12-13. There is insufficient antecedent basis for this limitation in the claim. The terms “a secondary sensor” and “a secondary sensor signal” should be “a sensor” and “a sensor signal”, due to the numbering of the elements.
Regarding claim 11, the term “air separator” is indefinite and/or unknown as it is an element that is described based on its action alone. No structure or definition could be found in the specification to guide the interpretation of this term.
Claim 13 recites the limitation “the sensor signal” in line 4. There is insufficient antecedent basis for this limitation in the claim. Currently the claims recite “a secondary sensor signal” in parent claim 1; however, this limitation can be changed, see above claim objection.
Claim 14 recites the limitation “the secondary sensor signal” in line 3. There is insufficient antecedent basis for this limitation in the claim. Currently the claims recite “a secondary sensor signal” in parent claim 1; however, this limitation can be changed, see above claim objection.
Regarding claim 15, in line 4, the term “ammonia (ammonium chloride)” should be amended to be distinctly claimed. It is currently indefinite as there are two components to ammonium chloride (both ammonium ion and the chloride ion) and a single component to ammonia (ammonia).
Regarding the dependent claims 2-20, these claims are rejected for the same reason as the base claim upon which they depend.
Claim Rejections - 35 USC § 103
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 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 1-3 and 10-12 are rejected under 35 U.S.C. 103 as being unpatentable over Linde (US 20050182349) (as cited in the Written Opinion filed 04/18/2024) in view of Voyce (US 20240000063) (newly cited).
Regarding claim 1, Linde discloses a system for supporting a patient organ (paragraphs [0002] and [0019]), the system comprising:
a primary circuit (paragraph [0073]; Fig. 4, elements 2, 6, 84, and 88) including an inlet (paragraph [0041]; Fig. 4, element 1 “double lumen venous catheter”) configured to connect to the patient (Fig. 4, “From Patient”) and an outlet (paragraph [0076]; Fig. 4, element 88 “patient return line”) configured to connect to the patient (Fig. 4, element “To Patient”), the primary circuit comprising:
a primary pump (paragraph [0041]; Fig. 4, element 4 “pump”) configured to circulate blood through the primary circuit and into the patient (Fig. 4);
a secondary circuit (paragraph [0073]; Fig. 4, elements 100, 58 (and other lines following therefrom), and 80) connected to the primary blood circuit (paragraph [0073]; Fig. 4, elements 2, 6, 84, and 88), the secondary circuit comprising:
an enclosure (paragraphs [0019]-[0020] and [0073]; Fig. 4, element 70 “bioreactor”) configured to support an organ therein in a blood flow (paragraphs [0019]-[0020]), the enclosure including a blood inlet (paragraph [0069], Fig. 4, element 62 “inlet line”) and a blood outlet (paragraph [0069]; Fig. 4, element 72 “outlet line”) to receive the blood flow through the enclosure and through the organ (paragraph [0069]);
a secondary pump (paragraph [0069]; Fig. 4, element 78 “pre-filter pump”) configured to circulate blood through the secondary circuit (paragraph [0073]; Fig. 4, elements 100, 58 (and other lines following therefrom), and 80);
a gas transfer unit (paragraphs [0042] and [0067]; Fig. 4, element 52 “oxygenator/warmer compartment”) configured to transfer gas to and from the blood (paragraphs [0042]-[0044]);
a secondary sensor (paragraph [0069]; Fig. 4, element 66 “in-line gas analyzers”) connected upstream (Fig. 4) of the enclosure (paragraphs [0019]-[0020] and [0073]; Fig. 4, element 70 “bioreactor”); and
a controller (paragraph [0045]).
PNG
media_image1.png
577
772
media_image1.png
Greyscale
Linde, Fig. 4
Linde does not disclose:
a secondary sensor … configured to produce a secondary sensor signal based on a condition of the blood; and
a controller configured to:
operate the gas transfer unit based on the secondary sensor signal.
Voyce discloses:
a secondary sensor (paragraph [0008]) … configured to produce a secondary sensor signal (paragraph [0008]) based on a condition of the blood (background section, paragraph [0002]); and
a controller (paragraph [0008] “controller”) configured to:
operate the gas transfer unit based on the secondary sensor signal (paragraph [0008]).
In the analogous art of precision oxygen flow control for organ perfusion systems, it would have been obvious to one skilled in the art before the effective filing date to modify Linde’s perfusion system with the oxygen sensor of Voyce in order to further oxygenate the organ if the oxygen levels are too low in the perfusate or whole blood in the perfusion circuit.
Regarding claim 2, Linde discloses further comprising:
a bypass circuit (paragraph [0073]; Fig. 4, element 89 “recirculation line”) connected to the primary circuit (paragraph [0073]; Fig. 4, elements 2, 6, 84, and 88) and the secondary circuit (paragraph [0073]; Fig. 4, elements 100, 58 (and other lines following therefrom), and 80) [sic, the bypass circuit]; and
a second primary pump (paragraph [0044]; Fig. 4, element 12 “pumps”) located downstream of the patient (Fig. 4), the second primary pump (paragraph [0044]) configured to circulate blood through the primary circuit and from the patient.
Regarding claim 3, modified Linde teaches the secondary circuit (see rejection to claim 1) comprising: a port (paragraphs [0043] and [0068]; Fig. 4, element 64) upstream of the enclosure (paragraphs [0019]-[0020] and [0073]; Fig. 4, element 70 “bioreactor”) for sampling of the blood (paragraphs [0043] and [0068]).
Regarding claim 10, Linde discloses wherein the gas transfer unit is an oxygenator (paragraphs [0042] and [0067] “oxygenator”).
Regarding claim 11, Linde does not disclose wherein the gas transfer unit includes an air separator.
Voyce discloses wherein the gas transfer unit includes an air separator (paragraph [0020] “a membrane”).
In the analogous art of precision oxygen flow control for organ perfusion systems, it would have been obvious to one skilled in the art before the effective filing date to modify the system of Linde with the air separator of Voyce in order to allow oxygen to pass into the perfusion fluid to oxygenate the perfusion fluid (Voyce, paragraph [0020]).
Regarding claim 12, Linde discloses further comprising:
a heating system (Fig. 4, element 54 “Heat Exchanger”; paragraph [0067]) connected to the gas transfer unit (Fig. 4, element 52 “oxygenator”; paragraph [0067]) to exchange heat with the blood through the gas transfer unit (paragraph [0067]).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Linde (US 20050182349) (as cited in the Written Opinion filed 04/18/2024) in view of Voyce (US 20240000063) (newly cited) as applied to claim 1, further in view of Goldman (US 5591399) (newly cited).
Regarding claim 4, Linde discloses further comprising:
a gas unit (paragraph [0017]) connected to the gas transfer unit (paragraphs [0042] and [0067]; Fig. 4, element 52 “oxygenator/warmer compartment”) and configured to deliver gas to the gas transfer unit.
Linde does not disclose a gas mixture unit.
Goldman discloses a gas mixture unit (col. 1, line 64 to col. 2, line 23).
In the analogous art of systems for diagnosing oxygenator failures, it would have been obvious to one skilled in the art before the effective filing date to modify modified Linde with the gas mixture unit of Goldman in order to proportion the gases to achieve the concentration designated (Goldman, col. 2, lines 3-6).
Claims 5-8 are rejected under 35 U.S.C. 103 as being unpatentable over Linde (US 20050182349) (as cited in the Written Opinion filed 04/18/2024) in view of Voyce (US 20240000063) (newly cited) and Goldman (US 5591399) (newly cited) as applied to claim 4, further in view of Ellingboe (US 20020085952) (newly cited).
Regarding claim 5, Linde does not disclose wherein the secondary sensor includes a pressure transducer configured to transmit a pressure signal to the controller based on a pressure of the blood and a temperature sensor configured to transmit a temperature signal to the controller based on a temperature of the blood, the controller to operate the gas transfer unit, the primary pump, and the secondary pump based on the pressure signal and the temperature signal.
Ellingboe discloses wherein the secondary sensor includes a pressure transducer (paragraph [0015] “pressure sensor”) configured to transmit a pressure signal to the controller (paragraph [0015] “control unit of the system”) based on a pressure of the blood (paragraph [0015] “fluid pressure of the oxygenated blood”) and a temperature sensor (paragraph [0015]) configured to transmit a temperature signal to the controller (paragraph [0031] “user interface … temperature”) based on a temperature of the blood (paragraph [0015]), the controller to operate the gas transfer unit (paragraph [0036] “oxygenator”), the primary pump (paragraph [0036] “first pump”), and the secondary pump (paragraph [0029] “second pump”) based on the pressure signal (paragraph [0021]) and the temperature signal (paragraph [0023]).
In the analogous art of blood perfusion systems, it would have been obvious to one skilled in the art before the effective filing date to modify the system of modified Linde with the sensor system and controller of Ellingboe in order to sense parameters such as pressure and temperature to conduct the flow of fluid through the passageways of the circuit (Ellingboe, paragraph [0023]) to keep the fluid parameters within a predetermined range (Ellingboe, paragraph [0031]).
Regarding claim 6, Linde discloses the secondary circuit (paragraph [0073]; Fig. 4, elements 100, 58 (and other lines following therefrom), and 80) comprising:
an inlet dissolved oxygen sensor (paragraphs [0062] and [0069]; Fig. 4, element 66 “in-line gas analyzers”) upstream of the enclosure (Fig. 4); and
an outlet dissolved oxygen sensor (paragraphs [0062] and [0069]; Fig. 4, element 66 “in-line gas analyzers”) downstream of the enclosure (Fig. 4); and,
the controller (paragraph [0045] “control console”).
Regarding the limitations “configured to transmit an inlet oxygen signal to the controller based on an inlet dissolved oxygen level of the blood” and “configured to transmit an outlet oxygen signal to the controller based on an outlet dissolved oxygen level of the blood”, the limitations are not specifically disclosed in Linde, however, it would have been obvious to one skilled in the art before the effective filing date to modify the system of modified Linde with these connections in order to monitor dissolved oxygen, partial pressure of oxygen, or oxygen saturation in the blood of the patient for the purposes of keeping the patient healthy and oxygenated.
Nevertheless, the limitations are disclosed in Ellingboe (paragraph [0139] “oxygen saturation-hematocrit sensor… provide feedback for use in various control circuits”).
In the analogous art of blood perfusion systems, it would have been obvious to one skilled in the art before the effective filing date to modify the system of modified Linde with these connections of Ellingboe in order to monitor dissolved oxygen, partial pressure of oxygen, or oxygen saturation in the blood of the patient for the purposes of keeping the patient healthy and oxygenated.
Regarding claim 7, Linde discloses wherein the controller is configured to determine an oxygen use rate of the organ based on the inlet oxygen signal and the outlet oxygen signal, (Table 2; Figs. 5-9; and paragraphs [0128]-[0130]) and wherein the controller (paragraph [0045] “control console”) is configured to operate the gas transfer unit (paragraph [0042]), the primary pump (Fig. 4, element 4 “pump” and paragraph [0041]), and the secondary pump (Fig. 4, element 12 “pump” and paragraph [0044]) based on the oxygen use rate of the organ (paragraphs [0128]-[0130]).
Regarding claim 8, Linde discloses wherein the controller is configured to determine an oxygen use rate of the organ based on the inlet oxygen signal and the outlet oxygen signal, (Table 2; Figs. 5-9; and paragraphs [0128]-[0130]) and wherein the controller (paragraph [0045] “control console”) is configured to operate the gas transfer unit (paragraph [0042]), the primary pump (Fig. 4, element 4 “pump” and paragraph [0041]), and the secondary pump (Fig. 4, element 12 “pump” and paragraph [0044]) based on the oxygen use rate of the organ (paragraphs [0128]-[0130]).
Regarding the term “patient organ”, Linde does not disclose the term in the above limitation.
However, it would have been obvious to one skilled in the art before the effective filing date to modify the placement of oxygen sensors in the circuit of Linde to sense the oxygen levels to and from the patient in order to detect the oxygen consumption rate of the organ within the patient so that the health and efficacy of the patient organ can be observed.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Linde (US 20050182349) (as cited in the Written Opinion filed 04/18/2024) in view of Voyce (US 20240000063) (newly cited) as applied to claim 2, further in view of Ellingboe (US 20020085952) (newly cited).
Regarding claim 9, Linde discloses the gas transfer unit (paragraphs [0042] and [0067] “oxygenator”).
Linde does not disclose the secondary circuit comprising: a bubble trap and a bubble sensor upstream of the gas transfer unit.
Ellingboe discloses a bubble trap (paragraphs [0025] and [0163] “bubble trap”) and a bubble sensor (paragraphs [0148] and [0163]) downstream of the gas transfer unit (paragraph [0148]).
In the analogous art of blood perfusion systems, it would have been obvious to one skilled in the art before the effective filing date to modify the system of Linde with the bubble trap and bubble sensor of Ellingboe in order to detect and trap bubbles from entering the system’s fluid lines, thereby preventing air bubbles within the patient’s bloodstream.
Regarding the limitation “upstream”, rearrangement of parts would have been obvious to one of ordinary skill in the art as an obvious matter of design choice and would not have modified the operation of the device. MPEP § 2144.04(VI)(C). It would have been obvious to one skilled in the art before the effective filing date to modify the system of Linde with the upstream orientation for the bubble trap and bubble sensor in order to detect and trap bubbles from entering the system’s fluid lines, thereby preventing air bubbles within the oxygenator and the patient’s bloodstream.
Claims 13-15 are rejected under 35 U.S.C. 103 as being unpatentable over Linde (US 20050182349) (as cited in the Written Opinion filed 04/18/2024) in view of Voyce (US 20240000063) (newly cited) as applied to claim 1, further in view of Becker (US 20200375178) (newly cited).
Regarding claim 13, Linde discloses further comprising:
an injection system (paragraph [0067]; Fig. 4, element 40 “glucose pump”) connected to the secondary circuit (paragraph [0073]; Fig. 4, elements 100, 58 (and other lines following therefrom), and 80) upstream (Fig. 4) of the enclosure (paragraphs [0019]-[0020] and [0073]; Fig. 4, element 70 “bioreactor”) and in communication with the controller (paragraph [0045] “control console”), the controller configured to operate the injection system (paragraph [0067]; Fig. 4, element 40 “glucose pump”).
Linde does not disclose the limitation “based on the sensor signal to deliver supplements to the blood”.
Becker discloses: based on the sensor signal (paragraph [0072] “sensor for monitoring the glucose level”) to deliver supplements to the blood (paragraph [0142] “insulin” or “glucagon”).
In the analogous art of perfusion loops assembly for an ex-vivo liver perfusion, it would have been obvious to one skilled in the art before the effective filing date to modify the system of modified Linde with the sensor signal and supplements of Becker in order to deliver the correct amount of glucose to the organ (Becker, paragraph [0142]).
Regarding claim 14, Linde discloses: the injection system (paragraph [0067]; Fig. 4, element 40 “glucose pump”) configured to deliver a supplement to the blood; and, the controller (paragraph [0045]).
Linde does not disclose: wherein the injection system includes a plurality of injection pumps each configured to deliver a supplement to the blood, the controller configured to operate each of the injection pumps based on the secondary sensor signal to deliver supplements to the blood.
Becker discloses: wherein the injection system includes a plurality of injection pumps (paragraphs [0212] and [0129] “syringe pumps”) each configured to deliver a supplement to the blood (paragraphs [0141]-[0143]), the controller configured to operate each of the injection pumps based on the secondary sensor signal (paragraphs [1042]-[0143]) to deliver supplements to the blood.
In the analogous art of perfusion loops assembly for an ex-vivo liver perfusion, it would have been obvious to one skilled in the art before the effective filing date to modify the system of modified Linde with the sensor signal and multiple supplements with respective pumps of Becker in order to deliver the correct amount of glucose to the organ (Becker, paragraph [0142]).
If it is deemed that modified Linde does not disclose the limitation “a plurality of injection pumps”, mere duplication of parts has no patentable significance unless a new and unexpected result is produced. MPEP § 2144.04(VI)(B). It would have been obvious to one skilled in the art before the effective filing date to modify the system of modified Linde with the sensor signal and multiple supplements with respective pumps of Becker in order to deliver the correct amount of glucose to the organ (Becker, paragraph [0142]).
Regarding claim 15, Linde discloses wherein an injection pump is configured to deliver to the blood and the organ, one or more of glucose (paragraph [0067]; Fig. 4, element 40 “glucose pump”).
Linde does not disclose the limitation “the plurality of injection pumps are each configured to deliver to the blood and the organ, one or more of cell culture media, cells, glutamine, … buffer, sodium chloride, essential amino acids, non-essential amino acids, drugs, ammonia (ammonium chloride), HEPES (C8H18N2O4S), Sodium Bicarbonate, Insulin, Epinephrine, Albumin, linoleic acid, dexamethasone, and glucagon”.
Regarding the limitation “the plurality of injection pumps”, mere duplication of parts has no patentable significance unless a new and unexpected result is produced. MPEP § 2144.04(VI)(B). It would have been obvious to one skilled in the art before the effective filing date to modify the system of modified Linde with the sensor signal and multiple supplements with respective pumps in order to deliver supplementary nutrition to the organ.
Nevertheless, Becker discloses the limitation: the plurality of injection pumps are each configured to deliver to the blood and the organ, one or more of (paragraphs [0212] and [0129] “syringe pumps”) insulin and glucagon (paragraph [0142] “insulin” or “glucagon”).
In the analogous art of perfusion loops assembly for an ex-vivo liver perfusion, it would have been obvious to one skilled in the art before the effective filing date to modify the system of modified Linde with the sensor signal and multiple supplements with respective pumps of Becker in order to deliver the correct amount of glucose to the organ (Becker, paragraph [0142]).
Regarding the limitation “cell culture media, cells, glutamine, glucose, buffer, sodium chloride, essential amino acids, non-essential amino acids, drugs, ammonia (ammonium chloride), HEPES (C8H18N2O4S), Sodium Bicarbonate, Insulin, Epinephrine, Albumin, linoleic acid, dexamethasone, and glucagon”, the limitation is phrased in the alternative. Because at least one of the limitations is rejected above, no further rejections are required at this time.
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Linde (US 20050182349) (as cited in the Written Opinion filed 04/18/2024) in view of Voyce (US 20240000063) (newly cited) and Becker (US 20200375178) (newly cited) as applied to claim 15, further in view of Ellingboe (US 20020085952) (newly cited).
Regarding claim 16, Linde discloses the injection system (paragraph [0067]; Fig. 4, element 40 “glucose pump”) includes an injection pump and a supplement (paragraph [0067]; Fig. 4, element 40 “glucose pump”).
Linde does not disclose wherein the injection system includes an enclosure supporting the plurality of injection pumps and the supplements
Ellingboe discloses an enclosure (paragraphs [0089] and [0091]; Fig. 1, element 10 “control unit”) supporting the plurality of injection pumps (paragraphs [0089] and [0091] “roller pump assemblies 31-36”).
In the analogous art of blood perfusion systems, it would have been obvious to one skilled in the art before the effective filing date to modify the system of Linde with the pumps’ housing of Ellingboe in order to hold the pumps in a vertical configuration that would take less space in the length and width of a space (the area) of a room.
Regarding the limitation “and the supplements”, Becker discloses the limitation (paragraph [0142] “insulin” or “glucagon”).
In the analogous art of perfusion loops assembly for an ex-vivo liver perfusion, it would have been obvious to one skilled in the art before the effective filing date to modify the system of modified Linde with the sensor signal and multiple supplements with respective pumps of Becker in order to deliver the correct amount of glucose to the organ (Becker, paragraph [0142]).
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Linde (US 20050182349) (as cited in the Written Opinion filed 04/18/2024) in view of Voyce (US 20240000063) (newly cited), Becker (US 20200375178) (newly cited), and Ellingboe (US 20020085952) (newly cited), as applied to claim 16, further in view of Carson (US 20030163183) (newly cited).
Regarding claim 17, Linde discloses an injection system (paragraph [0067]; Fig. 4, element 40 “glucose pump”) and a controller (paragraph [0045]).
Linde does not disclose wherein the injection system includes a cooling system configured to cool an environment of the injection system, the cooling system in communication with the controller, the controller configured to operate the cooling system to maintain a desired temperature of the environment of the injection system.
Ellingboe discloses a cooling system (paragraphs [0117] and [0214]) configured to cool an environment (paragraph [0214]), the cooling system in communication with the controller (paragraph [0214] “temperature control systems”), the controller configured to operate the cooling system to maintain a desired temperature of the environment (paragraph [0214]).
In the analogous art of blood perfusion systems, it would have been obvious to one skilled in the art before the effective filing date to modify the system of modified Linde with the controlled cooling system of Ellingboe in order to cool the technical components of the invention, such as peristaltic pumps or syringe pumps, or electronics therefor.
Regarding the limitations “an environment of the injection system” and “the environment of the injection system”, it would have been obvious to one skilled in the art before the effective filing date to modify the system of modified Linde with a controlled cooling system of Ellingboe in order to cool the injection pump components housed in an injection system’s environmental enclosure.
If it is deemed that the disclosures above do not fulfill the limitation, Carson discloses a chip-controlled fan for a cooling system (paragraphs [0053]-[0054]).
It would have been obvious to one skilled in the art before the effective filing date to modify the system of modified Linde with a chip-controlled fan of Carson in order to cool the injection pump components housed in an injection system’s environmental enclosure.
Claims 18-19 are rejected under 35 U.S.C. 103 as being unpatentable over Linde (US 20050182349) (as cited in the Written Opinion filed 04/18/2024) in view of Voyce (US 20240000063) (newly cited) as applied to claim 1; or, under 35 U.S.C. 103 as being unpatentable over Linde (US 20050182349) (as cited in the Written Opinion filed 04/18/2024) in view of Voyce (US 20240000063) (newly cited) as applied to claim 1, further in view of Becker (US 20200375178) (newly cited).
Regarding claim 18, Linde discloses a storage container (paragraph [0073]; Fig. 4, element 32 ultrafiltrate generator or “UF generator”), a discharge of the enclosure (paragraph [0069]; Fig. 4, element 72 “bioreactor outlet line”), a discharge of an organ (paragraphs [0019]-[0020]), the secondary pump (paragraph [0069]; Fig. 4, element 78 “pre-filter pump”), and the primary pump (paragraph [0041]; Fig. 4, element 4 “pump”).
Linde does not disclose further comprising: a storage container connected to a discharge of the enclosure and connectable to a discharge of a vessel of the organ, the storage container located upstream of the secondary pump and the primary pump.
Regarding this limitation, rearrangement of parts would have been obvious to one of ordinary skill in the art as an obvious matter of design choice and would not have modified the operation of the device. MPEP § 2144.04(VI)(C). It would have been obvious to one skilled in the art before the effective filing date to modify the arrangement of the components of the perfusion loop as disclosed in Linde in order to have a storage container or reservoir that would handle fluidic capacitance in the perfusion circuits, so the circuits would not abruptly run dry with bubbles during operation if uneven flow occurs.
Regarding the limitation “a discharge of a vessel of the organ”, if the limitation is not deemed to be fulfilled above or inherent to the attached organ, Becker discloses a discharge of a vessel of the organ (Fig. 1 “Vena Cava”; paragraph [0013]).
In the analogous art of perfusion loop assemblies for an ex-vivo liver perfusion, it would have been obvious to one skilled in the art before the effective filing date to modify the discharge of an organ to have a discharge vessel in order to have an outlet for the blood or perfusion fluid to exit the organ.
Regarding claim 19, Linde discloses further comprising: a filter located at least partially within the storage container and configured to filter perfusate passing through the storage container (paragraph [0011] “the UF generator is arranged … and the system can thus separate dialyzed fluid into an ultrafiltrate and a concentrated fluid fraction”).
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Linde (US 20050182349) (as cited in the Written Opinion filed 04/18/2024) in view of Voyce (US 20240000063) (newly cited) as applied to claim 18, further in view of Arzt (US 20140326678) (newly cited); or, under 35 U.S.C. 103 as being unpatentable over Linde (US 20050182349) (as cited in the Written Opinion filed 04/18/2024) in view of Voyce (US 20240000063) (newly cited) and Becker (US 20200375178) (newly cited) as applied to claim 18, further in view of Arzt (US 20140326678) (newly cited).
Regarding claim 20, Linde discloses the gas transfer unit (paragraphs [0042] and [0067]; Fig. 4, element 52 “oxygenator/warmer compartment”) and the storage container (paragraph [0073]; Fig. 4, element 32 ultrafiltrate generator or “UF generator”).
Linde does not disclose further comprising: a purge line connected to the gas transfer unit and connected to the storage container.
Arzt discloses further comprising: a purge line (paragraph [0059], Fig. 5, element 18 “venting line”) connected to the gas transfer unit (paragraph [0059], Fig. 5, element 3 “oxygenator”) and connected to a storage container (paragraph [0059], Fig. 5, element 2 “reservoir”, “connected separably to the upper part of the reservoir”).
In the analogous art of methods and systems for filling and venting a device for extracorporeal blood treatment, it would have been obvious to one skilled in the art before the effective filing date to modify the system of modified Linde with the purge line of Arzt in order to remove air and/or bubbles detected during the setup or operation of the system (Arzt, paragraph [0104]).
Additional Prior Art References
The prior art made of record and not relied upon is considered pertinent to Applicant’s disclosure.
Bacchetta (US 20190141985) (newly cited) – This invention is a cross-circulation platform for extracorporeal organs.
Anderson (US 20140045167) (newly cited) – This invention contains an organ perfusion oxygen rate consumption calculation.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NATHAN G ESPERON whose telephone number is 571-272-9807. The examiner can normally be reached 9 am - 6 pm Monday through Thursday, and 9 am - 6 pm every other Friday.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, Applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Marcheschi can be reached at 571-272-1374. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/N.G.E./Examiner, Art Unit 1799
/MICHAEL A MARCHESCHI/Supervisory Patent Examiner, Art Unit 1799
Prosecution Insights