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 .
Response to Amendments/Arguments
Applicant’s amendments and arguments, filed 26 January 2026, with respect to the rejections of the claims, as amended, over Sterman have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Herzlinger, as presented below.
Applicant argued that Sterman does not disclose or suggest the use of catheters that support a flow rate of 700mL/min. The Examiner agrees and has added the Herzlinger reference to teach the new limitations.
Claim Rejections - 35 USC § 103
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.
Claims 1, 4-13, 25, 30, are rejected under 35 U.S.C. 103 as being unpatentable over US 6,699,231 to Sterman et al in view of WO 2020/236626 to Herzlinger et al.
In the specification and figures, Sterman discloses the method and apparatus substantially as claimed by Applicant. With regard to claims 1, 25, and 30, Sterman discloses a method and apparatus for perfusing an organ (which may comprise a kidney) of a patient including placing a perfusion catheter 10 in to an artery of the organ, positioning a recovery catheter 16 in a vein of the organ, wherein the catheters and an oxygenation device with a pump form a closed circuit, and perfusing the organ through the circuit (see FIGS 2, 3, column 4, lines 35-40). Sterman does not disclose a membrane oxygenation device, but discloses that the components may comprise items that are used in conventional cardiopulmonary bypass circuits (see column 9, lines 55-65). It would be within a skill of a worker in the art to select a membrane oxygenator, which is used in conventional cardiopulmonary bypass circuits, to perform the method as disclosed by Sterman.
Sterman does not disclose the use of catheters that may withstand a 700mL/min flow rate. However, Herzlinger discloses a method of providing extracorporeal circulation, wherein the flow rate may be as high or higher than as 700 mL/min, teaching that such catheters are known in the art (see FIG 1, ¶0096).
Where a claimed improvement on a device or apparatus is no more than "the simple substitution of one known element for another or the mere application of a known technique to a piece of prior art ready for improvement," the claim is unpatentable under 35 U.S.C. 103(a). Ex Parte Smith, 83 USPQ.2d 1509, 1518-19 (BPAI, 2007) (citing KSR v. Teleflex, 127 S.Ct. 1727, 1740, 82 USPQ2d 1385, 1396 (2007)). Applicant claims a combination that only unites old elements with no change in the respective functions of those old elements, and the combination of those elements yields predictable results; absent evidence that the modifications necessary to effect the combination of elements is uniquely challenging or difficult for one of ordinary skill in the art, the claim is unpatentable as obvious under 35 U.S.C. 103(a). Ex Parte Smith, 83 USPQ.2d at 1518-19 (BPAI, 2007) (citing KSR, 127 S.Ct. at 1740, 82 USPQ2d at1396. Accordingly, since the applicant[s] have submitted no persuasive evidence that the combination of the above elements is uniquely challenging or difficult for one of ordinary skill in the art, the claim is unpatentable as obvious under 35 U.S.C. 103(a) because it is no more than the predictable use of prior art elements according to their established functions resulting in the simple substitution of one known element for another or the mere application of a known technique to a piece of prior art ready for improvement.
In the instant case, it would have been obvious to a person having ordinary skill in the art at the time of filing to use the catheters disclosed by Herzlinger in the apparatus and method disclosed by Sterman, since all elements were known in the art at the time of filing.
With regard to claims 4 and 5, Sterman teaches that the isolated perfused organ may comprise a kidney, which, to one of ordinary skill in the art, means placing the catheters via the arteria femoralis and the vena femoralis (see FIG 9 and accompanying text).
With regard to claim 6, Sterman discloses a recirculating embodiment, in which the perfusate passes through the oxygenator prior to entering the artery (see column 9, lines 45-65).
With regard to claim 7, Sterman discloses that additional perfusate may be added to the recirculation system (see FIG 3, column 15, lines 45-50).
With regard to claim 8, Sterman does not disclose the flow rates as claimed by Applicant. However, a perfusionist is highly skilled in the art of organ perfusion, and it is within the skill of a perfusionist to calculate and select the proper flow rate to treat a patient.
With regard to claim 9, Sterman discloses a pump and an oxygenator, wherein the pump provides negative pressure to the recovery catheter (see FIG 3 and accompanying text). Sterman does not disclose the pressure ranges claimed by Applicant. However, It has been held that where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. See MPEP § 2144.05(II)(A).
With regard to claim 10, Sterman discloses that the catheters may be implanted percutaneously (see column 15, lines 1-5).
With regard to claims 11 and 13, Sterman discloses a recirculation embodiment that circulates patient blood for a desired time period (see column 16, lines 34-48, column 25, lines 1-15). Sterman does not disclose the time periods claimed by Applicant. However, It has been held that where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. See MPEP § 2144.05(II)(A).
With regard to claim 12, Sterman does not teach the step of selecting blood components based on the presence of antibodies. Sterman does teach the use of antibodies as a treatment, suggesting the limitations of the claim (see column 4, lines 35-58).
Claims 2 and 3 are rejected under 35 U.S.C. 103 as being unpatentable over US 6,699,231 to Sterman et al in view of WO 2020/236626 to Herzlinger et al, further in view of Maiden1.
In the specification and figures, the cited prior art suggests the method and apparatus substantially as claimed by Applicant (see rejections above). With regard to claims 2 and 3,, Sterman does not disclose the steps of positioning a recovery balloon catheter in the bladder or the ureters. However, such techniques are known in the art of isolated organ perfusion as taught by Maiden. Maiden discloses that it is standard procedure to cannulate the renal artery, vein, and ureter in order to assess filtration and urine production. Since the ureter is connected to the bladder, one of ordinary skill in the art would find it equally desirable to cannulate the ureter, as taught by Maiden, or the bladder. It would have been obvious to a person of ordinary skill in the art at the time of filing to place recovery catheters in the excretory path (as disclosed by Maiden) of the kidneys perfused by Sterman, in order to assess kidney function, as taught by Maiden.
Claims 14-17 are rejected under 35 U.S.C. 103 as being unpatentable over US 6,699,231 to Sterman et al in view of WO 2020/236626 to Herzlinger et al, further in view of US 2016/0324988 to Atkinson et al.
In the specification and figures, the cited prior art suggests the method and apparatus substantially as claimed by Applicant (see rejections above). With regard to claims 14-17, Sterman does not disclose the claimed components of the perfusate. However, Atkinson discloses methods for delivering fluid to kidney tissues in order to treat kidney injury and pathologies, wherein the perfusate may comprise a polynucleotide, adenovirus vectors or AAV (see ¶0115, 0128).
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over US 6,699,231 to Sterman et al in view of WO 2020/236626 to Herzlinger et al, in view of US 2016/0324988 to Atkinson et al, further in view of Pleyer2.
In the specification and figures, the cited prior art discloses the method and apparatus substantially as claimed by Applicant (see rejections above). With regard to claim 18, the prior art does not disclose the use of AAV serotypes in the perfusate. However, Pleyer discloses the identification of at least six serotypes suitable for gene therapy in 2003. As such, one of ordinary skill in the art at the time of filing could have looked at the discovered serotypes and used any one of the discovered serotypes for gene therapy.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. 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 nonprovisional extension fee (37 CFR 1.17(a)) 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 mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LESLIE R DEAK whose telephone number is (571)272-4943. The examiner can normally be reached Monday-Friday, 9am to 5:30pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sarah Al-Hashimi can be reached at 571-272-7159. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LESLIE R DEAK/Primary Examiner, Art Unit 3799 9 February 2026
1 Maiden, M. “Chapter 17- Experimental Models of Acute Kidney Injury.” Crit. Care Nephrology 3d Ed. 99-105, 100 (2019).
2 Pleyer U, Ritter T. “Gene therapy in immune-mediated diseases of the eye.” Progress in Retinal and Eye Res. 22:3 277-293, 283 (2003).