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 Amendment
The amendments filed on 10/20/2025 has been entered. Claims 13-24 are pending in this application. Claim 13 has been amended.
Response to Arguments
Applicant’s arguments with respect to claim(s) 13 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Though overall the same prior art references are used herein, the amendment of claim 13 necessitated in a change in the grounds of the rejection as detailed below in the prior art rejection.
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) 13 and 20-24 are rejected under 35 U.S.C. 103 as being unpatentable over Lura et al. (Publication No. US 2017/0021086 A1) in view of Gorsuch et al. (Publication No. US 2006/0106331 A1), and Pohlmeier et al. (Publication No. US 2017/0304522 A1).
Regarding claim 13, Lura teaches a method of priming an extracorporeal blood circuit (Abstract) using a blood treatment apparatus (Abstract) comprising a dialysis liquid preparation system (caddy; Figure 2-4; Paragraph 0123) having a source of water (water source is connected to main dialysate flow path 106; Paragraph 0116 and 0123), a source of bicarbonate concentrate (sodium bicarbonate container 102; Paragraph 0120; Figure 2-4) and a source of acid concentrate including sodium chloride (sodium chloride container 103 is filled mixed with water – Paragraph 0101 – ““sodium chloride reservoir” and “sodium chloride container”… can store a source of sodium, such as sodium chloride in solid and/or solution form” and solution form of sodium chloride is mixed with water to make saline solution; Paragraph 0120; Figure 2-4), the blood treatment apparatus configured to prepare a dialysis liquid from water, the bicarbonate concentrate and the acid concentrate only (Paragraph 0116-118 – water is mixed with sodium bicarbonate and sodium chloride fluid; Paragraph 0119 – cation infusate is optional to be administered in dialysis fluid), the method comprising a first phase comprising: preparing a priming solution from the source of water and the source of acid concentrate only to obtain an acid/water solution, wherein bicarbonate from the source of bicarbonate concentrate is absent from the solution (Paragraph 0116-0117 and 0121-0122; capable of only delivering an acid/water priming solution with the control of the pumps and valves).
Lura does not teach the source of acid concentrate including sodium chloride and another solute, the dialysis liquid preparation system not having or being connected to a source that has a solution of only sodium chloride.
However, Gorsuch teaches the source of acid concentrate including sodium chloride and another solute, the dialysis liquid preparation system not having or being connected to a source that has a solution of only sodium chloride (backflush fluid has saline and heparin; Claim 4 and 5; Paragraph 0021).
Lura and Gorsuch are considered to be analogous to the claimed invention because they are in the same field of extracorporeal blood circuits. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Lura to incorporate the teachings of Gorsuch and have the source of acid concentrate of Lura to include sodium chloride and heparin as the other solute, as taught by Gorsuch. This allows for system anticoagulation protection during hemodialysis (Gorsuch; Paragraph 0021).
The combination of Lura in view of Gorsuch does not teach wherein the extracorporeal blood circuit comprises an arterial line section, connectable to a patient, for drawing blood from the patient, a venous line section, connectable to the patient, for returning the blood to the patient, and a blood side compartment or blood chamber of a blood filter, connecting the arterial line section to an outlet of the dialysis liquid preparation system of the blood treatment apparatus and, filling the extracorporeal blood circuit with the priming solution.
However, Pohlmeier teaches wherein the extracorporeal blood circuit comprises an arterial line section, connectable to a patient, for drawing blood from the patient (arterial conduit section 1; Paragraph 0068; Figure 1), a venous line section, connectable to the patient, for returning the blood to the patient (venous conduit section 3; Paragraph 0068; Figure 1), and a blood side compartment or blood chamber of a blood filter (blood filter 3000 with chamber; Paragraph 0068; Figure 1), connecting the arterial line section to an outlet of the dialysis liquid preparation system of the blood treatment apparatus (arterial conduit section 1 is connected to the outlet of the priming fluid Q4’ through conduit 6; Figure 6; Paragraph 0073-0077) and, filling the extracorporeal blood circuit with the priming solution (Paragraph 0073-0077).
Lura in view of Gorsuch and Pohlmeier are considered to be analogous to the claimed invention because they are in the same field of extracorporeal blood circuits. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Lura in view of Gorsuch to incorporate the teachings of Pohlmeier and have the dialysis liquid preparation system of Lura in view of Gorsuch connected to the extracorporeal blood circuit with a controller of Pohlmeier to make a blood treatment device, as taught by Pohlmeier. This allows for the extracorporeal blood circuit to automate the priming and regulate/operate the blood treatment after priming (Pohlmeier; Paragraph 0044).
Regarding claim 20, Lura in view of Gorsuch and Pohlmeier teaches the method of claim 13. The combination of Lura in view of Gorsuch and Pohlmeier further teaches a control device or closed-loop control device configured to carry out or to initiate the method according to claim 13 in interaction with the blood treatment apparatus (Pohlmeier; Paragraph 0056 and 0086; see rejection of claim 1 above).
Regarding claim 21, Lura in view of Gorsuch and Pohlmeier teaches the control device or closed-loop control device of claim 20. The combination of Lura in view of Gorsuch and Pohlmeier further teaches a blood treatment apparatus for the extracorporeal treatment of a patient's blood (Pohlmeier; Abstract; Paragraph 0067-0069), comprising the control device or closed-loop control device according to claim 20 (see rejection of claim 20 above).
Regarding claim 22, Lura in view of Gorsuch and Pohlmeier teaches the apparatus of claim 21. The combination of Lura in view of Gorsuch and Pohlmeier further teaches wherein the blood treatment apparatus comprises a hemodialysis apparatus, hemofiltration apparatus or hemodiafiltration apparatus (Pohlmeier; Paragraph 0047-0048).
Regarding claim 23, Lura in view of Gorsuch and Pohlmeier teaches the apparatus of claim 21. The combination of Lura in view of Gorsuch and Pohlmeier further teaches wherein the blood treatment apparatus is configured for acute or chronic renal replacement therapy (Pohlmeier; apparatus is fully capable to provide blood treatment for acute or chronic renal replacement therapy; Paragraph 0047-0048).
Regarding claim 24, Lura in view of Gorsuch and Pohlmeier teaches the apparatus of claim 23. Lura further teaches further comprising sensors arranged and configured to measure a sodium concentration, in the priming solution (concentration/conductivity sensor to measure sodium based concentrations in priming solution; Paragraph 0124, 0126, and 0145).
Claim(s) 14-19 are rejected under 35 U.S.C. 103 as being unpatentable over Lura et al. (Publication No. US 2017/0021086 A1) in view of Gorsuch et al. (Publication No. US 2006/0106331 A1) and Pohlmeier et al. (Publication No. US 2017/0304522 A1), as applied to claim 13 above, and further in view of Martens (Publication No. US 2008/0077087 A1).
Regarding claim 14, Lura in view of Gorsuch and Pohlmeier teaches the method of claim 13. The combination of Lura in view of Gorsuch and Pohlmeier does not teach wherein during the first phase the temperature of the priming solution is kept below 35°C.
However, Martens teaches wherein during the first phase the temperature of the priming solution is kept below 35°C (Paragraph 0005 – saline, water with NaCl solution, is stored at room temperature or 25 degrees Celsius; Paragraph 0028).
Lura in view of Gorsuch and Pohlmeier and Martens are considered to be analogous to the claimed invention because they are in the same field of intravenous fluid devices. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Lura in view of Gorsuch and Pohlmeier to incorporate the teachings of Martens and have the first phase temperature of the water with sodium chloride solution to be at room temperature. This allows for the stable storage of saline to be maintained before fluid is used for administration (Martens; Paragraph 0005).
Regarding claim 15, Lura in view of Gorsuch and Pohlmeier teaches the method of claim 13. The combination of Lura in view of Gorsuch and Pohlmeier does not teach wherein during the first phase the temperature of the priming solution is kept between 25°C and 30°C.
However, Martens teaches wherein during the first phase the temperature of the priming solution is kept between 25°C and 30°C (Paragraph 0005 – saline, water with NaCl solution, is stored at room temperature or 25 degrees Celsius; Paragraph 0028).
Lura in view of Gorsuch and Pohlmeier and Martens are considered to be analogous to the claimed invention because they are in the same field of intravenous fluid devices. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Lura in view of Gorsuch and Pohlmeier to incorporate the teachings of Martens and have the first phase temperature of the water with sodium chloride solution to be at room temperature. This allows for the stable storage of saline to be maintained before fluid is used for administration (Martens; Paragraph 0005).
Regarding claim 16, Lura in view of Gorsuch and Pohlmeier and Martens teaches the method of claim 15. Lura further teaches wherein the method further comprises a second phase, following the first phase, the second phase comprising: adding bicarbonate from the source of bicarbonate concentrate to the priming solution (Paragraph 0117-0118).
Regarding claim 17, Lura in view of Gorsuch and Pohlmeier and Martens teaches the method of claim 16. The combination of Lura in view of Gorsuch and Pohlmeier and Martens does not teach wherein during the second phase the temperature of the priming solution is raised to at least 35°C.
However, Martens teaches wherein during the second phase the temperature of the priming solution is raised to at least 35°C (Paragraph 0005; solution is warmed to body temperature, 36 to 38 degrees Celsius, before administering; Paragraph 0027).
Lura in view of Gorsuch and Pohlmeier and Martens are considered to be analogous to the claimed invention because they are in the same field of intravenous fluid devices. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Lura in view of Gorsuch and Pohlmeier to incorporate the teachings of Martens and have the second phase temperature of the water, bicarbonate, and sodium bicarbonate to be heated to body temperature by incorpating the heating device of Martens in the dialysis preparation system of Lura in view of Gorsuch and Pohlmeier. This allows for the patient’s temperature to be maintained when the fluids are administered (Martens; Paragraph 0005).
Regarding claim 18, Lura in view of Gorsuch and Pohlmeier and Martens teaches the method of claim 16. The combination of Lura in view of Gorsuch and Pohlmeier and Martens does not teach wherein the priming is continued for at least 5 minutes before the priming is considered as completed.
However, Polhmeier teaches wherein the priming is continued for at least 5 minutes before the priming is considered as completed (priming fluid fills the extracorporeal circuit for between 10 and 15 minutes, preferably between 12 and 13 minutes, more preferably 12.5 minutes; Paragraph 0039).
Pohlmeier is analogous to the claimed invention because they are in the same field of extracorporeal blood circuits. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Lura in view of Gorsuch and Pohlmeier and Martens to incorporate the teachings of Pohlmeier and have the priming of the circuit be more than 5 minutes, as taught by Pohlmeier. This allows for the extracorporeal blood circuit to avoid hypocalcemia (Pohlmeier; Paragraph 0039).
Regarding claim 19, Lura in view of Gorsuch and Pohlmeier and Martens teaches the method of claim 18. The combination of Lura in view of Gorsuch and Pohlmeier and Martens further teaches wherein circulation of the priming solution within the extracorporeal circuit is continued for at least 5 minutes before the priming is considered as completed (Pohlmeier; priming fluid is conveyed through the circuit for a maximum time of 15 minutes; Paragraph 0040).
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 KATHERINE-PH M PHAM whose telephone number is (571)272-0468. The examiner can normally be reached Mon-Fri, 8AM to 5PM ET.
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, Rebecca Eisenberg can be reached at (571) 270-5879. 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.
/KATHERINE-PH MINH PHAM/Examiner, Art Unit 3781
/KAI H WENG/Primary Examiner, Art Unit 3781