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 22-36, 38-39, and 41-57 are pending (claim set as filed on 04/07/2026).
Applicant’s election without traverse of Group II, apparatus/system claims, in the reply filed on 12/02/2025 is acknowledged.
Claims 30-36, 38-39, 41-57 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 apparatus/system claims 22-29 are presented for examination.
Priority
This application is a 371 of PCT/IB2021/052546 filed on 03/26/2021, which has a provisional application no.: 63/001,304 filed on 03/28/2020.
Information Disclosure Statement
The Information Disclosure Statement (IDS) submitted on 06/04/2026 is acknowledged. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the Examiner.
Withdrawal of Rejections
The response and amendments filed on 04/07/2026 are acknowledged. Any previously applied minor objections and/or minor rejections (i.e., formal matters), not explicitly restated herein for brevity, have been withdrawn necessitated by Applicant’s formality corrections and/or amendments. For the purposes of clarity of the record, the reasons for the Examiner’s withdrawal, and/or maintaining if applicable, of the substantive or essential claim rejections are detailed directly below and/or in the Examiner’s response to arguments section.
The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Maintained Rejections
Claim Rejections - 35 USC §103, Obviousness
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 22-24 and 28-29 are rejected under 35 U.S.C. 103 as being unpatentable over Chapman (US 2017/0188571 A1) in view of Bagnato (US 2020/0138015 A1).
Chapman’s general disclosure relates to systems and methods for normothermic extracorporeal organ perfusion (see ¶ [0002]). The organ to be perfused may be a body organ liver, kidney, heart, lung, spleen, and pancreas (see ¶ [0008], [0096]).
Chapman teaches “a normothermic extracorporeal organ perfusion system. This system may be used for perfusion of ex-vivo organs at a warm physiological temperature. In one aspect, this system encompasses an active system and uses the flow pumps to assist in the flow of fluid. The system may also include a dialyzer that helps in maintaining the perfusate volume, removes impurities, and maintains pH that allows for longer perfusion time on the perfusion system. One aspect encompasses a parallel circuit of a reservoir, at least one centrifugal pump, a membrane oxygenator, a heat exchanger, a dialyzer, a flow control, at least one pressure probe, at least one flow probe, a measurement cell for real-time monitoring of oxygen saturation and hematocrit, and an organ chamber. The reservoir may be used to store the perfusate. The membrane oxygenator may be used to exchange the carbon dioxide in the perfusate to oxygen. The dialyzer may be used to remove excess liquid and impurities from the perfusate and maintain the pH of the perfusate” (see ¶ [0006]-[0008], [0098]-[0099]).
Chapman teaches the flows and pressures may be constantly monitored and the hematocrit may be kept between about 20 and about 25 by ultra-filtration of excess fluid by dialysis and at various rates of mL or units per hour (see ¶ [0100]-[0103]).
However, Chapman does not teach: a deoxygenator for deoxygenating the organ perfusion solution (claim 22’s 2nd limitation); or a blood cell filter for capturing blood cells flushed from the organ during perfusion (claim 29’s limitation).
Bagnato’s general disclosure relates to systems and methods for inactivating micro-organisms in donor organs such as lungs using ex vivo perfusion (see ¶ [0002]-[0004], [0008]-[0009]). Bagnato teaches ex vivo lung perfusion (EVLP) with a ventilator, perfusion solution, et. al. (see ¶ [0095]-[0100]). Bagnato teaches “lung perfusate is pumped using a centrifugal pump into the membrane (De)oxygenator where it is deoxygenated by a gas mixture (for example 86% N2, 8% CO2 and 6% O2) and warmed to normothermia and heat exchanger (heater/cooler) 413. The lung perfusate then optionally passes through a leukocyte filter before reentering the lungs” (see ¶ [0166]-[0167]).
Regarding claim 23, Bagnato teaches “the perfusate is a lung perfusate. In one embodiment, the flow rate is 1.5 liters per minute to ensure constant flow in the lung and/or accommodate the lung size. In another embodiment, the flow rate is 2 liters per minute to ensure constant flow in the lung and/or accommodate the lung size. In a further embodiment, the flow rate is 2.5 liters per minute to ensure constant flow in the lung and/or accommodate the lung size” (see ¶ [0109]-[0111]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to employ or use a deoxygenator for deoxygenating the organ perfusion solution such as taught by Bagnato in the organ perfusion system of Chapman. The ordinary artisan would have been motivated to do so is because the use of a deoxygenator would allow for the control of oxygen levels which is an objective of Chapman (see, e.g., Chapman at ¶ [0098]). Moreover, it would have been further obvious to employ or use a blood cell filter such as taught by Bagnato to purify or remove impurities before returning the perfusate back to the lungs. The ordinary artisan would have had a reasonable expectation of success because both of the cited references are directed to ex vivo organ perfusion apparatuses.
Regarding claims 22 and 24 pertaining to the “directly connecting an input vessel of the organ or a conduit that defines a return fluid path directly connecting to an outlet vessel of the organ”, the primary reference of Chapman invites modification “having described several embodiments, it will be recognized by those skilled in the art that various modifications, alternative constructions, and equivalents may be used without departing from the spirit of the invention. Additionally, a number of well-known processes and elements have not been described in order to avoid unnecessarily obscuring the present invention. Accordingly, the above description should not be taken as limiting the scope of the invention” (see Chapman at ¶ [0013], [0161]-[0162]). Furthermore, the MPEP 2144.04 provides “examples directed to various common practices which the court has held normally require only ordinary skill in the art and hence are considered routine expedients” which include: reversal of parts, duplication of parts, or rearrangement of parts, wherein the particular placement of device was held to be an obvious matter of design choice. In other words, the amended claim limitations featuring direct connection of the delivery fluid paths to the vessel of an organ is deemed a matter of engineering and design choice within the purview of the ordinary artisan.
Claims 25-27 are rejected under 35 U.S.C. 103 as being unpatentable over Chapman in view of Bagnato as applied to claims 22-24 and 28-29 above, and in further view of Storr (US 2019/0247560 A1).
The combined disclosures of Chapman and Bagnato, herein referred to as modified-Chapman-Bagnato, is discussed above as it pertains to an organ perfusion system.
However, modified-Chapman-Bagnato does not teach: a dialysis filter cartridge (claim 25); or continuous veno-venous hemodialysis without filtration (claim 26); or a dialysis filter cartridge that comprises a polyarylethysulfone (PAES) membrane (claim 27).
Storr an “extracorporeal blood circuit according to the invention is configured to perform hemoperfusion. Accordingly, the blood treatment device according to the invention is perfused with whole blood and is located within an extracorporeal circuit (FIG. 3). According to one aspect of the invention, the device is a cartridge comprising a membrane … the cartridge can be located downstream or upstream of a hemodialyzer which is configured to perform hemodialysis on the blood of a patient (FIGS. 4A and 4B) and can be operated in different treatment modes selected from hemodialysis, hemodiafiltration and hemofiltration” (see ¶ [0153]-[0154]).
Storr teaches membranes are adaptable to be used in various sizes and formats (see ¶ [0127]) and further teaches hemodialysis hollow fiber membrane dialyzer, wherein the filter is a hemodialyzer (see ¶ [0128]). Storr teaches a blood treatment device wherein the hollow fiber membrane is composed of at least one polysaccharide derivative or synthetic polymer including polyarylethersulfone (PAES) (see ¶ [0063], [0129]).
It would have been obvious to one of ordinary skill in the art to employ or use a dialysis filter cartridge for hemodialysis for dialyzing out molecules of different sizes such as taught by Storr in the organ perfusion system of modified-Chapman-Bagnato. The ordinary artisan would have been motivated to do so because the filter cartridge allows for the replacement and in dialyzing out different molecules. Furthermore, it would have also been obvious to substitute a membrane comprising PAES such as taught by Storr as it would have been deemed to a simple substitution of one known element for another.
Examiner’s Response to Arguments
Applicant’s amendments and arguments filed on 04/07/2026 have been fully considered but they are not persuasive and deemed insufficient to overcome the prior arts of record.
In response to Applicant’s argument (addressing pages 11-13 of the remarks) that Chapman nor Bagnato teach the amended claim limitation of “directly connecting an input vessel of the organ or a conduit that defines a return fluid path directly connecting to an outlet vessel of the organ”: this argument is not persuasive because the MPEP 2141.02(I) states that “In determining the differences between the prior art and the claims, the question under 35 U.S.C. 103 is not whether the differences themselves would have been obvious, but whether the claimed invention as a whole would have been obvious”. In the instant case, the claimed invention and cited reference, as a whole, are directed to systems and methods for organ perfusion and the primary reference of Chapman invites modification “having described several embodiments, it will be recognized by those skilled in the art that various modifications, alternative constructions, and equivalents may be used without departing from the spirit of the invention. Additionally, a number of well-known processes and elements have not been described in order to avoid unnecessarily obscuring the present invention. Accordingly, the above description should not be taken as limiting the scope of the invention” (see Chapman at ¶ [0013], [0161]-[0162]). Furthermore, the MPEP 2144.04 provides “examples directed to various common practices which the court has held normally require only ordinary skill in the art and hence are considered routine expedients” which include: reversal of parts, duplication of parts, or rearrangement of parts, wherein the particular placement of device was held to be an obvious matter of design choice. In other words, the amended claim limitations featuring direct connection of the delivery fluid paths to the vessel of an organ is deemed a matter of engineering and design choice within the purview of the ordinary artisan. There is no assertion from Applicant regarding an alleged benefit, advantage, or a patentable significance of the amended claim features such as increased viability or decreased necrosis of the organ.
Conclusion
No claims were allowed.
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 extension fee 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 date of this final action.
Correspondence Information
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/NGHI V NGUYEN/Primary Examiner, Art Unit 1653
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