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 12/02/2025).
Election/Restrictions
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Claims 30-36, 38-39, 41-57 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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.
Drawings
The drawings filed on 09/27/2022 have been accepted.
Information Disclosure Statement
No Information Disclosure Statement (IDS) has been filed in this application. Applicant is reminded that each individual associated with the filing and prosecution of a patent application has a duty of candor and good faith in dealing with the U.S. Patent and Trademark Office, which includes a duty to disclose to the Office all information known to that individual to be material to patentability (see 37 C.F.R. §1.56).
Abstract Objection
The abstract of the disclosure is objected to because it does not comply with the proper language and format (see MPEP 608.01(b)). Appropriate correction is required.
Applicant is reminded of the proper language and format for an abstract of the disclosure. The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words. It is important that the abstract not exceed 150 words in length since the space provided for the abstract on the computer tape used by the printer is limited. The form and legal phraseology often used in patent claims, such as “means” and “said” should be avoided. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details. The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns”, “The disclosure defined by this invention”, or “The disclosure describes”, etc.
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.
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.
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.
Conclusion
No claims were allowed.
Correspondence Information
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/NGHI V NGUYEN/Primary Examiner, Art Unit 1653