Patent Application 17761074 - ORGAN PERFUSION SYSTEM AND METHOD - Rejection

Patent Application 17761074 - ORGAN PERFUSION SYSTEM AND METHOD

Title: ORGAN PERFUSION SYSTEM AND METHOD

Application Information

• Invention Title: ORGAN PERFUSION SYSTEM AND METHOD
• Application Number: 17761074
• Submission Date: 2025-04-08T00:00:00.000Z
• Effective Filing Date: 2022-03-16T00:00:00.000Z
• Filing Date: 2022-03-16T00:00:00.000Z
• National Class: 435
• National Sub-Class: 001200
• Examiner Employee Number: 88556
• Art Unit: 1653
• Tech Center: 1600

Rejection Summary

• 102 Rejections: 2
• 103 Rejections: 1

Cited Patents

The following patents were cited in the rejection:

• US 1913691🔗
• US 0275364🔗
• US 0049096🔗

Office Action Text

    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 .

Status of the Claims    
Claims 1-23 are pending (claim set as filed on 03/14/2025).

Election/Restrictions
Applicant’s election without traverse of Group I, method claims, in the reply filed on 03/14/2025 is acknowledged. 
Claims 11-23 drawn to the device are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. 
Therefore, only method claims 1-10 are presented for examination.

Priority
	This application is a 371 of PCT/EP2020/065011 filed on 05/29/2020, which has a foreign application to UK 1913691.0 filed on 09/23/2019.

Drawings
	The drawings filed on 03/16/2022 have been accepted.

Information Disclosure Statement
The Information Disclosure Statements (IDS) submitted on 03/16/2022 and 09/23/2022 are acknowledged. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the Examiner.

Claim Rejections - 35 USC §102, Anticipation
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 1-5 and 7-10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hassanein (US 2007/0275364 A1).
	Hassanein’s general disclosure relates to system, methods, and devices relating to portable ex vivo organ care at near physiological conditions and methods of adequate perfusion (see abstract & ¶ [0002]). In particular, Hassanein teaches ex vivo organ care of the heart (see ¶ [0003]-[0004]). 
	Regarding claims 1-3 pertaining to a perfusion method, Hassanein teaches an organ care system (OCS) that circulates an oxygenated nutrient enriched perfusion fluid to an organ at or near physiological temperature, pressure, and flow rate (see ¶ [0010]). Hassanein teaches the OCS includes a module that has a chassis, an organ chamber assembly that is mounted to the chassis and is adapted to contain a heart during perfusion. The organ care system (OCS) includes a fluid conduit with a first interface for connecting to an aorta of the heart and a second interface for connecting to a pulmonary vein of the heart. The organ care system also includes a sensor for measuring lactate differentials and the aortic pressure in the OCS (see ¶ [0012], [0095]). Hassanein further teaches that prior to cannulating the harvested heart, the system requires priming wherein various parameters are initialized and calibrated via the operator interface during priming and the system further provides an organ bypass conduit 810 installed into the organ chamber assembly wherein the organ bypass conduit includes three segments to enables the system to be thoroughly tested and primed prior to cannulating the heart into place (see ¶ [0019], [0223]-[0224], Figure 27). Hassanein further teaches that the OCS comprises: a reservoir, a perfusion fluid circulation pump, a heater assembly for maintaining temperature, a flow mode selector, an oxygenator, a nutritional reservoir, and a sensor subsystem for monitoring temperature, pressure, flow rate, and/or oxygenation of the perfusion fluid, an operator interface for assisting an operator in monitoring system operations and/or conditions of the heart, and/or for enabling the operator to set various operator parameters, and a control subsystem for controlling operation of the OCS (see ¶ [0015]-[0018], [0155]-[0159]). Hassanein teaches the sensors include electrocardiogram, perfusion fluid flow rate, and/or flow pressure sensors, which provide feedback for controlling the perfusion fluid pump (see ¶ [0020]-[0021], [0107]). Hassanein teaches a method of determining or evaluating heart perfusion status comprising placing a heart in a protective chamber, pumping the perfusion fluid through the heart, and measuring the differential lactate values of the fluid leading to and away from the heart (see ¶ [0013]). Hassanein teaches “If the function and characteristics of the heart are not acceptable, the system can be adjusted as appropriate, for example, to provide appropriate fluid oxygenation or nutritional levels, or to increase or decrease the appropriate fluid temperature” (see ¶ [0226]-[0230]). 
	Regarding claims 4 and 7 pertaining to the temperature and volume rate, Hassanein teaches a perfusion fluid heater assembly to provide temperature control of the fluid and further includes temperature sensors for reporting the temperatures (see ¶ [0027]-[0033], [0095], [0121]). The perfusion fluid being at a temperature of between about 25°C and about 37°C, and at a volume of between about 200 ml/min and about 5 L/min, monitoring one or more physiologic characteristics of the heart while it is beating in the protective chamber, and adjusting a pumping characteristic based at least in part on the electrical characteristics to preserve the heart ex vivo (see ¶ [0045]-[0046], [0124]). Hassanein teaches “In response to detecting that the temperature of the perfusion fluid is within the operator-selected temperature range, the controller maintains the drive signals and at constant or substantially constant levels” (see ¶ [0137], [0139]).
Regarding claim 5 pertaining to the pressure, Hassanein teaches the fluid back-pressure provided to the aorta is between about 55 mmHg and about 85 mmHg, which is within an acceptable near-physiologic range of mean aortic blood pressure (which is typically between about 80 mmHg and about 100 mmHg) (see ¶ [0107]). 
Regarding claim 8 pertaining to the gaseous mix, Hassanein further teaches the ABG (carbon dioxide) and electrolytes are within acceptable ranges, SvO2 is >80% (see ¶ [0231]). Hassanein teaches “the gas includes an oxygen and carbon dioxide mixture. An exemplary composition of such a mixture contains about 85% O2, about 1% CO2, with the balance being N2. Subsequent to re-oxygenation, the oxygenator returns the perfusion fluid to the reservoir” (see ¶ [0103], [0301]).
	Regarding claims 9-10 pertaining to monitoring parameters, Hassanein teaches the OCS includes one or more oxygen saturation sensors to measure the oxygen saturation level of the perfusion fluid to ensure that the perfusion fluid is maintained at physiological oxygen levels (see ¶ [0017], [0301]). Hassanein teaches the nutritional subsystem replenishes the nutrients in the perfusion fluid as they are metabolized by the organ (see ¶ [0015], [0095]). Hassanein teaches the system includes a plurality of compliance chambers for stimulating the human body’s vascular compliance by aiding the system in mimicking blood flow and used for regulating back pressure seen by the aorta during normal flow mode operation (see ¶ [0020]).


Claims 1-7 and 9-10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Steen (WO 2011/037511 A1 - cited by the ISA and in the IDS filed on 03/16/2022). 	
Steen’s general disclosure relates to a method and a device for treatment of a heart after harvesting and a perfusion fluid therefore (see page 1, lines 5-7). 
Regarding claims 1-3 pertaining to a method of extracorporeal perfusion of a heart, Steen teaches a device for the treatment of a heart after harvesting and before transplantation wherein the device comprises a container for the heart, a first line for connection to an aorta, a fluid circuit comprising an oxygenator for oxygenating said fluid and a heater/cooler for regulating the temperature of said fluid; and a pump (36) for perfusion of said fluid through the coronary blood vessels of the heart (see abstract & Figures 1-4). Steen teaches a method for treatment of a heart after harvesting and before transplantation, comprising: arranging the heart in a container; connecting an aorta of the heart to a source of a perfusion fluid; oxygenating and possibly regulating the temperature of said fluid; perfusion of said fluid through the coronary blood vessels of the heart; wherein said fluid comprising an oncotic agent exerting an oncotic pressure larger than about 30 mmHg; said fluid being cardioplegic; and said perfusion being performed at a pressure, which is at least 15 mmHg and at least 15 mmHg lower than said oncotic pressure (see page 1, lines 26-33).
Regarding claim 4 pertaining to the temperature, Steen teaches a decrease to about 30°C may be appropriate, but the harvesting of the organs should be performed at a temperature of no less than about 34°C (see page 6, lines 4-9, & page 7, lines 4-14).
Regarding claims 5-6 pertaining to the pressure and pump, Steen teaches “the oncotic pressure should be sufficient to counteract swelling. We have found that an oncotic pressure higher than 30 mmHg would be sufficient in most cases, although 40 mmHg would guarantee that swelling does not occur. Since the heart is exposed to a mechanical pressure during circulation, an oncotic pressure of between 50 mmHg and 70 mmHg may be used in certain situations” (see page 7, lines 33-37). Steen teaches “the pump may be a conventional peristaltic pump or a centrifugal pump or any other type of pump” (see page 12, lines 26-37).
Regarding claim 7 pertaining to the volume rate, Steen teaches the flow rate is within specified limits, such as between 50 ml/min and 200 ml/min (see pages 12-13, lines 33-2). 
Regarding claims 9-10 pertaining to the monitoring, Steen teaches “the method may further comprise: monitoring at least one of the following parameters of the fluid: temperature; pressure before the heart; pressure after the heart; flow rate; oxygenation level before the heart; oxygenation level after the heart; pH; carbon dioxide level; color; and adjusting the perfusion in accordance with at least one of said parameters” (see page 2, lines 23-27). Steen teaches “since the flow resistance of the heart is individual, it may be required to fine-tune the pressure and the flow rate, which may be performed by adjusting the pressure so that light red fluid exits the heart at the end of a perfusion period” (see page 9, lines 16-18, and page 14, lines 1-14). 

Claim Rejections - 35 USC §103, Obviousness
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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 non-obviousness.

Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Steen as applied to claims 1-7 and 9-10 above, and in view of Kay (US 2017/0049096 A1).
Steen’s disclosure is taught above as it as it pertains a method of perfusion of a heart.
However, Steen does not teach: wherein the perfusate is oxygenated using a gaseous mix of about 95% air to about 5% carbon dioxide (claim 8).
Kay’s general disclosure relates to perfusion systems for bodily organs, in particular human organs (see abstract & ¶ [0002]). In particular, Kay discloses “a system for extracorporeal organ perfusion in which a human or non-human organ can be preserved, for example prior to transplant into a patient. The system typically comprises a reservoir for perfusion fluid, which may be blood or another perfusion solution, and a circuit for circulating the fluid through the organ” (see ¶ [0003]). 
Kay teaches “a perfusion system for the perfusion of an organ, the system comprising a perfusion fluid circuit for circulating perfusion fluid through the organ, adjustment means for adjusting the content of at least one component in the fluid, measuring means for measuring the content of said at least one component in the perfusion fluid, and control means arranged to control the adjustment means … the at least one component comprises carbon dioxide, and the adjustment means may comprises carbon dioxide extraction means arranged to extract carbon dioxide from the fluid. This may be arranged to supply air, or another gas, which can absorb or extract carbon dioxide from the fluid. This function can be performed by an oxygenator which also supplies oxygen, or it can be performed by a separate device or system” (see ¶ [0004]-[0009] & [0055]). Kay teaches “the carbon dioxide (CO2) level in the perfusate is also monitored and controlled by the controller 18 during perfusion in a similar way to the oxygen level, with the controller 18 continuously using the CO2 level signal from the BGA 192 to measure the CO2 level in the perfusate, comparing it with target levels stored in memory in the controller 18, and controlling the air flow control valve 226 to control the flow rate of air into the oxygenator 16. The target CO2 level can also be set and adjusted by a user by means of the user input 17” (see ¶ [0068]-[0069]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to employ a perfusate that is oxygenated using a gaseous mix of about 95% air to about 5% carbon dioxide in the method of Steen. The ordinary artisan would have been motivated to do so is because Kay discloses that blood gas levels may be monitored and adjusted to optimize the levels for the organ. Thus, the perfusate fluid gas mix contents are optimizable variables within the purview of the ordinary artisan to determine and considered a routine expedient. 
Conclusion
No claims were allowed.

Correspondence Information
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/NGHI V NGUYEN/Primary Examiner, Art Unit 1653