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 Amendment
Applicant’s arguments filed 05/08/2026 have been entered. Claims 1-20 are pending in the application, claims 14-20 are withdrawn, the 112(b) rejections previously set forth are withdrawn in view of the arguments and amendment.
Response to Arguments
Applicant's arguments filed 05/08/2026 have been fully considered but they are not persuasive.
In response to applicant’s argument that Davidner does not teach “a dedicated recirculation path between a blood reservoir and a filtration device” or “closed loop recirculation” examiner notes applicant’s arguments are not commensurate in scope with the claim language, Davidner teaches a recirculation loop connecting a pheresis system, oxygenator, reservoir and patient, and flow controlled such that pump 120 slowly withdraws blood into the extracorporeal device, and clamps are opened and closed to a high flow rate in the recirculation loop (C10/L4-63), blood which exits the reservoir is pumped into pheresis system 150 (C8/L62-68), Fig. 4, such that the flow rates would be decoupled, of simultaneous and/or intermittent treatment using separate treatment modalities (C1/L5-10), where blood is shunted to the reservoir, subjected to treatment, back to the reservoir, and may be recirculated or returned to the patient (C12/L10-44) as discussed below, and during treatment blood is preferably maintained under very slow flow conditions by circulating through a reservoir for a period of time, after which the blood is returned to the patient or shunted to an additional treatment (C6/L17-55, C11/L10-41) returning treated blood via a recirculating blood processing loop connecting the blood chamber to the legacy system. Absent clarification of the claim language, the art reads on the claims.
Claim Interpretation
Claim 1 recites wherein the filtration device is part of a legacy system, legacy system is interpreted in view of the instant specification to include dual lumen devices/catheters (0005) plasma exchange and apheresis devices, for example, hemodialysis (HD), liver dialysis, hemoperfusion, oxygenator, extracorporeal CO2 removal, combinations thereof (0016 -0019, 0060), or equivalents thereof.
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.
Claim(s)1, 2, 4, 7, 9, 12, 13 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Davidner (US 4,950,225).
With respect to claim 1, Davidner teaches a method for treating blood (abstract, a blood treatment method), where blood is withdrawn from a vein of a patient through a single lumen cannula 80 and directed to reservoir 98 (Fig. 4, C3/L15-62, C5/C6, C8/L4-62 (a) conveying a volume of blood via a first conduit from a vascular access of a patient to a blood chamber, the first conduit having only a single lumen); blood is subjected to treatments methods including shear, thermic treatment, irradiation treatment, including membrane oxygenation and pheresis (C5/L43-C6/L16, C8/L27-35, C10-12, (b) conveying the blood from the blood chamber through a filtration device wherein the filtration device is part of a legacy system, to perform an extracorporeal treatment on the blood (see claim interpretation of legacy system), in an embodiment blood is shunted to the reservoir, subjected to treatment, back to the reservoir, and may be recirculated or returned to the patient (C12/L10-44, and returning the treated blood to the blood chamber; and (c) returning the blood from the blood chamber to the vascular access of the patient), that pump 120 slowly withdraws blood into the extracorporeal device, and clamps are opened and closed to a high flow rate in the recirculation loop (C10/L4-63), blood which exits the reservoir is pumped into pheresis system 150 (C8/L62-68), Fig. 4, such that the flow rates in would be decoupled from and independent from of both the first and third flow rates.
Applcant amended to require: the returning of the treated blood via a recirculating blood processing loop connecting the blood chamber to the legacy system;
Davidner teaches the circuit capable of simultaneous and/or intermittent treatment using separate treatment modalities (C1/L5-10), where blood is shunted to the reservoir, subjected to treatment, back to the reservoir, and may be recirculated or returned to the patient (C12/L10-44) as discussed above, and during treatment blood is preferably maintained under very slow flow conditions by circulating through a reservoir for a period of time, after which the blood is returned to the patient or shunted to an additional treatment (C6/L17-55, C11/L10-41) returning treated blood via a recirculating blood processing loop connecting the blood chamber to the legacy system.
With respect to claim 2, the method of claim 1, is taught above. Davidner teaches a cannula as discussed above, wherein the first conduit is a needle or cannula forming at least part of the vascular access.
With respect to claim 4, the method of claim 1, is taught above. Davidner teaches an oxygenator and pheresis system as discussed above, the legacy system is a hemodialysis (HD) system, a hemoperfusion system, hemofiltration system, hemodiafiltration system, a liver dialysis system, an oxygenator, an extracorporeal CO2 removal (ECCO2R) system, a plasma exchange device and an apheresis device or a combination thereof.
With respect to claim 7, the method of claim 4 is taught above. Davidner teaches the device is capable of conducting the three separate treatments simultaneously and/or separately, in and order (C10/L19-42, wherein the combination of legacy systems is run in parallel or in series).
With respect to claim 9, the method of claim 1, is taught above. Davidner teaches a membrane oxygenation system (C6/L2, C8/L37-62, wherein the filtration device of the legacy system comprises a membrane or adsorption media).
With respect to claim 12, the method of claim 1, is taught above. Davidner teaches flow rate through the oxygenator of approximately 200 ml/min (C11/L15-21, wherein the second flow rate is 50 ml/min - 500 ml/min, inclusive).
With respect to claim 13, the method of claim 1, is taught above. Davidner teaches pumps 120 and 118 leading to an oxygenator and pheresis system respectively (Fig. 4), and the use of commercial systems for each (C5/L56-C6/L15, C7/L22-44, C8/L37-68, C11/L25-41). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to optimize the flow rate the second flow rate, depending on the manufacturers requirements for the filter, such that the flow rate is at least 300 ml/min, depending on the manufactures recommendations.
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.
Claim(s) 3 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Davidner (US 4,950,225), with evidence from Spearman (US 2019/0175813).
With respect to claim 3. the method of claim 2, is taught above. Davidner teaches withdrawal of blood is generally accomplished by insertion of a single or double lumen cannula into a sizeable vein such as the femoral vein, but is silent as to the size of the cannula, however, the selection of the size of the cannula would be an obvious choice to one of ordinary skill in the art before the effective filing date of the claimed invention, such that a catheter or needle of the first conduit has a size of either 2 to 20 French or 10 to 23 gauge, depending on the size of the patient and desired blood flow, as evidenced by Spearman, Spearman teaches catheter and cannula sizes can be determined by patient weight and blood flow requirements or desires. Ranges for these sizes can include: 18, 20, 22 and 24 French sizes.
Claim(s) 13 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Davidner (US 4,950,225).
With respect to claim 13, the method of claim 1, is taught above. Davidner teaches pumps 120 and 118 leading to an oxygenator and pheresis system respectively (Fig. 4), and the use of commercial systems for each (C5/L56-C6/L15, C7/L22-44, C8/L37-68, C11/L25-41). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to optimize the flow rate the second flow rate, depending on the manufacturers requirements for the filter, such that the flow rate is at least 300 ml/min, depending on the manufactures recommendations.
Claim(s) 5, 6, 8, 13 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Davidner (US 4,950,225), in view of Spearman (US 2019/0175813).
With respect to claim 5, the method of claim 4 is taught above. While Davidner does not explicitly teach the system includes a legacy hemodialysis (HD) system, Davidner teaches methods for extracorporeal blood treatment by way of an extracorporeal circuit capable of simultaneously and/or intermittently carrying out three separate treatment modalities, and a number of prior art devices are known of carrying out extracorporeal blood treatment and have become well established as routine, including dialysis (C1/L34-50), and extracorporeal treatment of blood using an oxygenator as discussed above. The use of extracorporeal treatment of blood using modalities of an oxygenator in combination with hemodialysis is known in the art as shown by Spearman, Spearman teaches a system of treating blood outside the body (abstract), where the system includes one or more dialysis modules and an oxygenator (0007), such that it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide a hemodialysis (HD) system, as according to Davidner the dialysis is routine and as shown by Spearmen the use of oxygenators and hemodialysis is known in the art, the courts have held that combining prior art elements according to known methods to yield predictable results would have been obvious to a person of ordinary skill in the art before the filing date, see MPEP §2143.
Davidner is silent as to the location of treatment or portability of the system, however, making a device portable is an obvious choice in order to allow for use in various locations, such as for home use, absent unexpected results, see MPEP 2144.01, V. A. fact that a claimed device is portable , such that it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide the legacy hemodialysis (HD) system is a portable system or suitable for home use (HHD).
With respect to claim 6, the method of claim 4, is taught above. Examiner suggests adding wherein the legacy system is a combination of legacy systems, to increase clarity.
As discussed above with respect to claim 5, the use of dialysis is known in the art. Spearman further teaches the system may further include removal of carbon dioxide from the blood (0007-0009, 0032, combination of legacy systems is hemodialysis (HD) and hemoperfusion, liver dialysis and hemoperfusion, extracorporeal C02 removal and hemodialysis (HD) or hemoperfusion, hemodialysis (HD) and ECCO2R), such that it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide CO2 removal and hemodialysis (HD), as according to Davidner dialysis is routine and as shown by Spearmen the use of oxygenators in use with CO2 removal and hemodialysis is known in the art, the courts have held that combining prior art elements according to known methods to yield predictable results would have been obvious to a person of ordinary skill in the art before the filing date, see MPEP §2143.
With respect to claim 8, the method of claim 1, is taught above. Davidner does not teach wherein the legacy system performs one or more mode(s) of hemodialysis selected from the group consisting of slow continuous ultrafiltration (SCUF), continuous venovenous hemodialysis (CVVHD), continuous venovenous hemodiafiltration (CVVHDF), and continuous venovenous high-flux hemodialysis (CVVHFD). As discussed above with respect to claim 5, Spearman teaches dialysis and oxygenation, and further teaches convection dialysis, and example of which is CVVH (0052), such that it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide one or more mode(s) of hemodialysis selected from the group consisting of slow continuous ultrafiltration (SCUF), continuous venovenous hemodialysis (CVVHD), as according to Davidner dialysis is routine and as according to Spearmen dialysis can be configured in accordance with various considerations such as the sizes and molecular weights of the toxins, the methods to remove the toxins (0050) and convection dialysis can better remove toxins in the range of 1 to 60,000 Daltons or higher.
With respect to claim 13, the method of claim 1, is taught above. Davidner teaches pumps 120 and 118 leading to an oxygenator and pheresis system respectively (Fig. 4), and the use of commercial systems for each (C5/L56-C6/L15, C7/L22-44, C8/L37-68, C11/L25-41). While Davidner does not explicitly teach the second flow rate is at least 300 ml/min, as discussed above with respect to Claim 5 Spearman teaches a system comprising an oxygenator and dialysis in the same system, and as an example flow rates in the dialysis system can range between 200 and 7000 ml/min (0053) such that it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide a hemodialysis (HD) system with flow rates in the dialysis system which can range between 200 and 7000 ml/min (0053), as according to Davidner the dialysis is routine and as shown by Spearmen the use of oxygenators and hemodialysis is known in the art, and as shown by Spearman flow rates of the second flow rate is at least 300 ml/min are known in the art and the courts have held that combining prior art elements according to known methods to yield predictable results would have been obvious to a person of ordinary skill in the art before the filing date, see MPEP §2143.
Claim(s) 10 ,11 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Davidner (US 4,950,225), in view of Bently (US 4,094792).
With respect to claims 10 and 11, the method of claim 9, is taught above. Davidner is silent as to the material of the membrane or wherein the membrane of the filtration device comprises at least one polymer which is a member selected from the group consisting of a polyamide, a polysulfone, a polyethersulfone, a cellulose acetate, a triacetate, a polyacrylonitrile and a polymethylmethacylate, each of the foregoing optionally surface modified for improved blood compatibility, the selection of a membrane polymer would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as the use of the recited membrane materials, including polysulfone is well known in the art, as shown by Bently, Bently teaches a membrane used to oxygenate blood (abstract), comprising polysulfone (claim 17).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-4, 6, 7, 12, 13 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, 6, 7, 18, 19, 20 of U.S. Patent No. 12,311,090.
Although the claims at issue are not identical, they are not patentably distinct from each other because the reference patent claims anticipate the instant claims by reciting narrowed versions of the
instant claims. The reference claims include substantially the same features i.e. conveying blood to a chamber at a first flow rate, through a filtration device at second flow rate, returning to the chamber at a third flow rate, via single lumen conduit, with additional features regarding the specific nature vascular access and blood monitoring. Dependent claims 2, 3, 4, 19, 20 correspond to instant claims, 2-4, dependent claims 6, 7 correspond to instant claims 12, 13.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
DiMilla (US 2003/0157709), independent flow rates, loop
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 JEANNIE MCDERMOTT whose telephone number is (571)272-4479. The examiner can normally be reached Monday - Friday 8:30 - 5:00 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jennifer Dieterle can be reached at 571 270-7872. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JEANNIE MCDERMOTT/Examiner, Art Unit 1776
/BRADLEY R SPIES/ Primary Examiner, Art Unit 1776
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