DETAILED ACTION
Note: 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 Claims
1. Claims 1-7 are pending and currently under consideration for patentability.
Priority
2. Acknowledgment is made of applicant's claim for foreign priority under 35 U.S.C. 119(a)-(d). The certified copy has been filed in the instant application.
Information Disclosure Statement
3. The information disclosure statements (IDS) submitted on January 22, 2024 and June 12, 2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the examiner.
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.
4. Claim(s) 1, 5 and 6 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Jansson et al. (US PGPUB 2014/0165733 A1).
5. With regard to claim 1, Jansson discloses a blood purification apparatus (hemodialysis machine, 1) configured to purify a patient's blood by causing the blood to extracorporeally circulate through a blood circuit (flow path, 2) and a blood purifier (membrane arrangement, 8; Figs. abstract), the blood circuit (2) including an arterial blood circuit (second portion of flow path, 4) and a venous blood circuit (first portion of flow path, 3; [0048]), the apparatus (1) being arbitrarily switchable between a double-needle state (‘double-needle mode’; Fig. 1) in which an arterial puncture needle (second needle, 9b) and a venous puncture needle (first needle, 9a) are connected to distal ends of the arterial blood circuit (4) and the venous blood circuit (3; [0049]), respectively, and a single-needle state (‘single-needle mode’; Fig. 2) in which a single needle (single needle, 9c) is connected to the distal ends of the arterial blood circuit (4) and the venous blood circuit (3) with an aid of a Y-shaped tube (blood access device, 9; [0003]; [0048]; [0050-0051]), the apparatus (1) comprising: a blood pump (pump, 7) configured to deliver liquid in the blood circuit (2; [0048]); a delivery-amount-detecting unit (detecting device, 20) configured to detect an amount of liquid delivery made with operation of the blood pump (7; implicit, as in the “second test” the pump adds a “known small volume”; [0056-0057]); a pressure detector (first pressure sensor, 5) configured to detect a pressure in the blood circuit (2; [0048]; [0054]); a chamber (first expansion chamber, 15) member connected in the single-needle state (Fig. 2) to the blood circuit (2) at a position on a downstream side relative to the blood pump (7; Fig. 2), the chamber member (15) being configured to receive and store the blood in the blood circuit (2) in a blood-collection phase in which blood is collected from the patient (implicit in hemodialysis) and to discharge the stored blood into the blood circuit (2) in a blood-return phase in which the blood is returned to the patient (implicit in hemodialysis; [0051] ;[0058-0059]); and a connection-checking unit (calculation unit, 10 or “controller”; [0055]) configured to check whether the chamber member is connected (“determine what type of tubing set is connected”; [0056]), the checking being performed with reference to the amount of liquid delivery (“known small volume”) detected by the delivery-amount-detecting unit (20) and the pressure detected by the pressure detector (5; “pressure measured after the volume has been added”; [0057]).
6. With regard to claims 5 and 6, Jansson discloses that the checking by the connection-checking unit (10) of whether the chamber member (15) is connected is performed at a start of a blood purification treatment (“start-up phase”) to be performed in the single-needle state (Fig. 2; [0054]; [0056]), or is performed in a connection test (“second test”) that is conducted with pressure application before blood purification treatment ([0054]; [0056]; [0073]).
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
7. Claim(s) 2 is rejected under 35 U.S.C. 103 as being unpatentable over Jansson in view of Mitschulat et al. (US PGPUB 2019/0167889 A1).
8. With regard to claim 2, Jansson discloses a venous clamp (14a) capable of opening and closing a flow route at a distal part of the venous blood circuit (3; Fig. 2; [0051]); and a control unit (“controller”; [0054]) capable of controlling switching between the blood-collection phase and the blood-return phase in the single- needle state (Fig. 2) in such a manner as to execute the blood-collection phase for blood collection by activating the blood pump (7) with the venous clamp (14a) closed, to switch to the blood-return phase ([0051]), to execute the blood-return phase for blood return by opening the venous clamp (14a) and stopping the blood pump (7), and to switch to the blood-collection phase ([0051]; [0054]), wherein the connection-checking unit (10) checks whether the chamber member (15) is connected by checking whether the amount of liquid delivery detected when an upper-limit pressure (“limits of tolerance”) at which the blood-collection phase is switched to the blood-return phase is reached exceeds a preset reference value (“reference value”; [0055]).
However, while Jansson discloses that the pressure detector (5) and controller (10 or separate controller; [0054]) are in communication with one another, where the controller utilizes preset reference values and preset limits of tolerance ([0055]), Jansson fails to explicitly disclose switching to the blood-return phase when the pressure detected by the pressure detector reaches a preset upper-limit pressure, and switching to the blood-collection phase when the pressure detected by the pressure detector reaches a preset lower-limit pressure
Mitschulat, within the same field of endeavor, discloses an automated method for leukocyte collection from whole blood (abstract; Figs. 2, 3) comprising: a control unit (processor device, 133; [0025]) configured to control switching between a blood-collection phase (“collect”) and a blood-return phase (“return”) in a single-needle state (Figs. 2, 3) in such a manner as to execute the blood-collection phase for blood collection by activating a blood pump (pump section, 20 and whole blood pump, 22) with a venous clamp (clamp, 110) closed (Figs. 2, 3; [0064]; [0074-0075]; [0097-0099]), to switch to the blood-return phase when the turbidity detected by a detector (“optical sensor”) reaches a preset upper-limit (“predefined threshold”), to execute the blood-return phase for blood return by opening the venous clamp (110) and stopping the blood pump (22), and to switch to the blood-collection phase when the turbidity detected by the detector reaches a preset lower-limit ([0040-0041]; [0075]; [0099]; [0109]).
Therefore, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the controller disclosed by Jansson to be configured to base the switching between blood-collection and blood-return on pressured rising above or falling below upper and lower limits, respectively, similar to that disclosed by Mitschulat, in order to allow for the blood-collection phase to be stopped automatically without user intervention, as suggested by Mitschulat in paragraph [0099].
9. Claim(s) 3, 4 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Jansson in view of Fresnius Medical et al. (DE 10 2005001779 A1).
10. With regard to claims 3, 4 and 7, while it is known common-practice within extracorporeal blood treatment systems to include a blood circuit that is an airless circuit in which no air layer is to be formed in a flow route through which the blood extracorporeally circulates in a double-needle state, Jansson is silent in regard to an air-trap chamber that is connected to the venous blood circuit and to and from which the chamber member is attachable and detachable; wherein the air-trap chamber is provided with a connection tube extending from a top of the air-trap chamber, and the chamber member is connectable to the connection tube with an arbitrary timing; and that the blood circuit is an airless circuit in which no air layer is to be formed in a flow route through which the blood extracorporeally circulates in the double-needle state.
However, within the same field of endeavor, Fresnius discloses a disposable set for extra-corporal blood treatment using either single- or dual-needle operation, includes air separator connecting to expansion unit to increase its volume (abstract; Figs. 1, 2, 4); an air-trap chamber (air separation unit, 9) that is connected to the venous blood circuit (8b) and to and from which the chamber member (expansion member, 36) is attachable and detachable (via fittings/coupling, 16 and 40; Fig. 4; [0042]); wherein the air-trap chamber (9) is provided with a connection tube (16, 40) extending from a top (11) of the air-trap chamber (9), and the chamber member (36) is capable of being connected to the connection tube (16, 40) with an arbitrary timing (inherently; Fig. 4; [0041-0042]); and that the blood circuit (circuit, 6) is an airless circuit in which no air layer is to be formed in a flow route (blood supply line, 7) through which the blood extracorporeally circulates in the double-needle state (Fig. 1; abstract; [0042]).
Therefore, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the blood purification apparatus disclosed by Jansson to include an air-trap chamber connectable to the chamber member, similar to that disclosed by Fresnius, in order to ensure separation of air from the extracorporeal circuit/system, as suggested in the abstract and throughout Fresnius, enhancing patient safety by reducing the risk of air-related complications, as is well-known in the art.
Conclusion
11. The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Troutner et al. (US 4,486,189) discloses a dual mode hemodialysis system.
Min (US PGPUB 2010/0217174 A1) discloses a blood processing system for single or double access draw and return.
Toyoda et al. (US PGPUB 2017/0361004 A1) disclose a blood purification apparatus.
12. Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANDREW J MENSH whose telephone number is (571)270-1594. The examiner can normally be reached M-F 9 a.m. - 6 p.m..
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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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/ANDREW J MENSH/ Primary Examiner, Art Unit 3781