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 .
Election/Restrictions
Applicant’s election without traverse of an organ perfusion/preservation system, corresponding to claims 1-13 in the reply filed on 4/29/2026, is acknowledged.
Claims 14-26 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected method of preserving/re-warming a donated organ, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 4/29/2026.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1,3,5 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by WO 2015138263 A1.
WO 2015138263 A1 discloses a portable organ perfusion system as found in Figure 1. The system comprising a fluid reservoir (40) containing a perfusion fluid (1). Perfusion fluid flows through an oxygenator (34) and into a reservoir (40). Pump-B (48) then draws oxygenated perfusion fluid from the reservoir (40) and pumps it toward the organ (2), wherein it first passes through a heat exchanger (50). This makes pump b (48) an inflow pump. A fluid line (7) connects the oxygenator to pump B and then connects pump B to the heat exchanger and then connects the heat exchanger to the organ. The perfusion fluid flows through the organ (2), which is in the organ chamber (3), and exits through a fluid line (7). A second pump, pump-A (15), which is in fluid connection with the fluid outflow line (7) and the reservoir (40), pumps fluid away from the organ and back towards the reservoir (40). Importantly, the inflow pump, the outflow pump and the heat exchanger are all operatively connected to the electronic control system (132). The electronic control system is configured to select parameters to reversibly heat and reversibly cool the organ. Specifically, "the electronic control system (132) adjusts the temperature of the perfusion fluid (1) by either heating or cooling of the fluid (1) to the desired temperature..." (paragraph 45). This disclosure contains all of the structural limitations of clam 1, and therefore anticipates claim 1. Additionally, "The electronic control system (132) is responsible for closed loop feedback for controlling temperature and serves as the control system for adjustments in pump speeds." (paragraph 85). Furthermore, "Pump-A (15), pump-B (48), and the dialysis fluid pump (25), are all connected to their respective controller hardware (138, 137, 136), each of which controls the on-off or speed of the motors as necessary." (paragraph 89). Importantly, "the overall average perfusion fluid rate for both pumps (15, 48) should be substantially identical under normal operation of the perfusion system." (paragraph 47). This anticipates claim 3 as it discloses a configuration where the inflow rate (pump-B (48)) and the outflow rate (pump-A (15)) are controlled independently of one another (see controllers 138 and 137), and the flow rates are equal. They also disclose that, 1) the heat exchanger controls the heating/cooling operations (paragraph 89), 2) that temperature is sensed and heat is removed or added to the perfusion fluid (paragraph 55), 3) the fluid may be chilled at some times or it may be heated at other times (paragraph 57), and 4) temperature control as a function of time is a capability of the controller (paragraph 92). Therefore, the electronic controller is disclosed as controlling temperature over time, including directing heating and cooling of perfusion fluid. The system expressly discloses the same perfusion fluid can be cooled for periods of time and heating during others. Therefore, the controller has the capability to cyclically warm and cool the perfusion fluid which results in cyclically heating or cooling the organ. This anticipates claim 5.
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.
Claims 2,4 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2015138263 A1 as applied to claim 1 above, and further in view of US 20190209762 A1.
WO 2015138263 A1 discloses a dual pump organ perfusion system as described above.
WO 2015138263 A1 does not disclose the integration of the heat exchanger and oxygenator into single unit and it does not disclose having the controller adjust flow rates based on the measured temperature of the perfusion fluid.
US 20190209762 A1 discloses a heat exchanger system intended to be used with extracorporeal fluid-based perfusion system. It discloses an integrated heat exchanger and oxygenator. Specifically, “in some embodiments, the perfusion system heat exchanger is part of an oxygenator.” (paragraph 0015). Additionally, they disclose a system wherein a controller adjusts flow rates based on measured fluid temperature. Specifically, “For instance, a controller may interpret the temperature value, as read by a temperature sensor of the temperature sensor arrangement, against a set temperature threshold. The controller may operate the flow-control arrangement to reduce or increase, as necessary, the rate at which temperature-controlled fluid is circulated…” (paragraph 0105).
Therefore, it would be obvious to a person of ordinary skill in the art, before the effective filing date, to use the integrated heat exchanger and oxygenator unit disclosed in US 20190209762 A1 in the dual pump perfusion system of WO 2015138263 A1. The integration of the two units reduces circuit complexity by reducing the number of components in the system. The resulting reduction in tubing connections reduces the potential contamination/leak points within the system.
Furthermore, it would be obvious to a person of ordinary skill in the art, before the effective filing date, to reprogram the modified perfusion system described above so that the electronic controller alters flow rates based on measured fluid temperature. Controlling perfusion fluid flow rates based on temperature provides a precise and efficient mechanism for thermal cycling in organ perfusion. By adjusting flow rate based on fluid temperature, the system can regulate the amount of time the perfusion fluid is in contact with/able to exchange heat with the organ and the heat exchange device. This provides more accurate and responsive warming and cooling cycles. Therefore, claims 2,4 are rendered obvious.
Claims 6-9 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2015138263 A1 as applied to claim 1 above, and further in view of US 6953655 B1.
WO 2015138263 A1 discloses the organ perfusion system as described above.
WO 2015138263 A1 does not disclose the perfusion fluid contain blood from the donor (autologous blood). They also do not disclose an organ chamber that is filled with fluid for immersing the organ, and that the immersion fluid contain a preservative.
US 6953655 B1 discloses an organ perfusion apparatus wherein both a perfusion fluid and an organ immersion fluid contain autologous blood and a preservation solution. They also disclose the organ chamber is filled with the immersion solution, resulting in submersion of the organ. Specifically, “The present invention provides a system for preserving a human or human-compatible harvested organ...(a) containment means for containing said organ in communication with a physiologic media or fluid comprising (i) whole blood (or leukocyte-depleted whole blood) compatible with said organ and (ii) a preservation solution;... delivery means for delivering said fluid to at least one major vessel of said organ…includes means for delivering said fluid to said containment means so that the exterior of said organ is substantially completely bathed in or surrounded by said fluid." (column 4).
It would be obvious to a person of ordinary skill in the art, before the effective filing date, to use the autologous blood and a preservation solution containing compositions (aka the perfusion immersion fluid compositions) disclosed in US6953655B1, in the dual pump perfusion circuit of WO 2015138263 A1 as both a veinous perfusate (perfusion fluid) and an organ immersion (immersion fluid). Using a perfusion fluid comprising autologous blood helps maintain organ health and structure by providing a physiologically natural perfusate. This reduces osmotic pressure/shock/damage, provides proteins and electrolytes, and facilitates pH stability. The result is maintenance of vascular integrity during the process. Incorporation of a preservation solution in the immersion fluid helps mitigate cellular and structural degradation through reduced swelling and mitigates oxygen deprivation-induced damage/degradation. Immersion provides protection from organ drying as well. This renders claims 6-9 obvious.
Claims 10-13 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2015138263 A1 as applied to claim 1 above, and further in view of US 10039879 B2 and US 5894011 A.
WO 2015138263 A1 discloses a dual pump organ perfusion system as described above.
WO 2015138263 A1 does not disclose incorporating a valve in the fluid circuit, wherein the valve alters the flow pathway of fluid selectively to one chamber or another in a dual chamber reservoir.
US 10039879 B2 discloses a closed-circuit, pump-driven medical device for circulating fluid through the circulatory system of a patient wherein the system contains a dual chambered reservoir in fluid communication with the patient and the pump. Specifically, "pump-driven infusion systems incorporating dual-chambered reservoirs for delivering medical fluid infusate to a patient in a closed configuration..." (column 3). They do not disclose an inlet valve controlling the fluid flow pathway into either chamber A or chamber B when entering the reservoir.
US 5894011 A discloses a closed-circuit, pump-driven medical device for circulating blood through the circulatory system of a patient wherein a “valve” is used to control the pathway the circulating fluid (blood) takes through the apparatus. Specifically, "The present invention is a device for reversing the direction of flow to and from the patient…a mechanism having a plurality of positions, said plurality comprising at least a first position that simultaneously aligns the first patient fluid fitting with the first blood treatment apparatus fluid fitting and the second patient fluid fitting with the second blood treatment apparatus fluid fitting, and a second position that simultaneously aligns the first patient fluid fitting with the second blood treatment apparatus fluid fitting and the second patient fluid fitting with the first blood treatment apparatus fluid fitting and, while in said first position and said second position, said mechanism maintaining substantially unobstructed fluid connections between aligned fluid fittings" (paragraph 1 in summary of the invention). Importantly, a valve is specifically disclosed in the exemplarily embodiment as shown in Figure 1.
Therefore, it would be obvious to a person of ordinary skill in the art, before the effective filling date, to implement dual chambered reservoir structure disclosed by US10039879B2 into the dual-pump organ perfusion apparatus disclosed in WO 2015138263 A1. Furthermore, it would be obvious to a person of ordinary skill in the art, before the effective filing date, to take the selective pathway control mechanism (aka valve) of US 5894011 A and use it to enable the dual-chambered reservoir perfusion system to selective exchange perfusion fluid. The additional structural features of a dual chamber reservoir comprising a valve that directs the organ perfusion outflow to one chamber or another enables an initial washout/ equilibration phase. When perfusion is started, equilibration between the organ and the perfusion fluid results in selective exchange of molecules, compounds, and gasses from organ to fluid and fluid to organ, fundamentally altering fluid outflow composition. When perfusion begins, the system can be configured to selectively route the initial returning/outflow fluid into a designated reservoir "waste" chamber while simultaneously maintaining inflow of uncontaminated perfusion fluid from the alternative chamber. Therefore, contaminated fluid is removed from the circuit and fresh/clean fluid is feed into the circuit. An additional benefit for this design is that it provides uninterrupted organ support by continuously maintaining circulation through the system. Once equilibration has completed, the valve can be turned to allow the outflow fluid to return to the initial reservoir chamber, instead of the waste chamber. This reduces the amount of perfusion fluid used in the process. This renders claims 10-13 obvious.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Adam M Smith whose telephone number is (571)272-7517. The examiner can normally be reached Monday- Friday 10:30AM-5PM.
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, Tracy Vivlemore can be reached at (571) 272-2914. 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.
/Tracy Vivlemore/ Supervisory Primary Examiner, Art Unit 1638
Prosecution Insights