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 .
This Office action is in response to communications filed June 2, 2026.
Status of Claims
1. Claims 1-14 are pending and currently under consideration for patentability.
Claims 8-14 are newly added as of the June 2, 2026 claim amendment.
Information Disclosure Statement
2. The information disclosure statements (IDS) submitted on August 2, 2026 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the examiner.
Response to Arguments
3. Applicant’s arguments with respect to claim(s) 1 and 3 have been considered but are moot because the new ground of rejection does not rely on the same combination of reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Furuhashi et al. (US PGPUB 2015/0151036) is newly cited as a secondary reference as necessitated by the instant amendment. Kell (US 4,412,916) is also introduced as a new secondary reference for addressing dependent claims.
With regard to applicant’s argument against the rejection of claim 2 in the most recent Office action; namely, that Mitschulat’s threshold is a predefined color rather than a pressure threshold, so Mitschulat cannot remedy Jansson’s deficiencies, examiner respectfully disagrees. In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Additionally, applicant is reminded that the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981). Jansson is the primary reference in the rejection of claim 2, and is already cited for disclosing 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), to switch to the blood-return phase ([0051]), to execute the blood-return phase for blood return, and to switch to the blood-collection phase ([0051]; [0054]), wherein the pressure detector (5) and controller (10 or separate controller; [0054]) are in communication with one another, wherein the controller utilizes preset reference values and preset limits of tolerance ([0055]). Mitschulat is merely utilized as a secondary reference whose combined teachings with Jansson render obvious the claimed control unit configuration; the features and particulars of Mitschulat are not intended to be bodily incorporated into the structure of Jansson, rather it is what the combined teachings of Jansson in view of Mitschulat would have suggested to those of ordinary skill in the art. Mitschulat 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]). While Mitschulat bases it phase switch control on turbidity/color thresholds, Jansson already discloses a control unit and associated pressure sensors. Accordingly it is maintained that 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].
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.
4. Claim(s) 1, 3-6 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Jansson et al. (US PGPUB 2014/0165733 A1) in view of Furuhashi et al. (US PGPUB 2015/0151036).
5. With regard to claims 1, 3 and 4, 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 venous blood circuit (3) in a blood-collection phase in which blood is collected from the patient (implicit in hemodialysis) and to discharge the stored blood into the venous blood circuit (3) 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]).
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 configured to remove bubbles from blood purified by a dialyzer, 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, Furuhashi discloses a blood purification apparatus and priming method for the same (abstract; Fig. 1) comprising an air-trap chamber (venous air trap chamber, 6) configured to remove bubbles from blood purified by a dialyzer (3; [0068]; [0076]), that is connected to the venous blood circuit (2) and to and from which the chamber member is attachable and detachable ([0009]; [0015]; [0066]; [0092]; [0102]); and wherein the air-trap chamber (6) is provided with a connection tube extending from a top of the air-trap chamber (6, connected to 3b; Fig. 1), and the chamber member is connectable to the connection tube with an arbitrary timing (inherently, depending on pre-use, post-use or replacement).
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 Furuhashi, in order to ensure efficient air bubble purging to prevent air bubbles from unintentionally flowing through the system, as suggested by Furuhashi in paragraphs [0092] and [0102], enhancing patient safety by reducing the risk of air-related complications, as is well-known in the art.
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]).
7. With regard to claim 14, Jansson discloses that the connection-checking unit (10) is further configured to perform a connection test (“second test”) before blood purification treatment ([0054]; [0056]; [0073]).
8. Claim(s) 2 is rejected under 35 U.S.C. 103 as being unpatentable over Jansson in view of Furuhashi, as applied to claim 1 above, and further in view of Mitschulat et al. (US PGPUB 2019/0167889 A1).
9. 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 and Furuhashi fail 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 in view of Furuhashi 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].
10. Claim(s) 7-12 are rejected under 35 U.S.C. 103 as being unpatentable over Jansson in view of Furuhashi, as applied to claim 1 above, and further in view of Kell (US 4,412,916).
11. With regard to claim 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 and Furuhashi are silent in regard to the blood circuit being 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 of hemodialysis, Kell discloses an airless artificial kidney assembly (abstract; Fig. 1), wherein 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 (col. 3, lines 40-47).
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 specified that the blood circuit disclosed by Jansson in view of Furuhashi is an airless blood circuit, similar to that disclosed by Kell, in order to ensure an airless assembly free of a blood-air interface at any location along the extracorporeal circuit, as suggested by Kell in column 3, lines 40-47, ensuring patient safety during use.
12. With regard to claim 8, Jansson and Furuhashi are silent in regard to the pressure detector further comprising a liquid-phase part, a gas-phase part, and a diaphragm that is configured to separate the liquid-phase part and the gas-phase part.
However, Kell discloses a pressure detector (blood pressure sensing device, 34) comprising a liquid-phase part, a gas-phase part (gas tight cavity, 70), and a diaphragm (54) that is configured to separate the liquid-phase part and the gas-phase part (Fig. 1; col. 6, lines 46-68).
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 pressure detector disclosed by Jansson in view of Furuhashi to include a liquid/gas diaphragm design, similar to that disclosed by Kell, in order to function to reflect small changes in pressure of the blood flowing in housing and the consequent deflection of the flexible convex dome into cavity as pressure increases, and vice versa; the gas that is thus displaced is transmitted to a previously calibrated pressure transducer, not shown, to provide a continuous pressure indication on a conventional indicator, or the transmitted gas may be used to activate an alarm or pressure control means to maintain the preset safe pressure level of normal operation, as suggested by Kell in column 6, line 63 to column 7, line 5.
13. With regard to claims 9-12, while Jansson discloses a chamber (15), a connecting part (port for connection to tubing) and a connecting tube (2, 3, 4; Fig. 2); wherein the connecting part of the chamber member is configured to be attachable to and detachable from a connecting part of the air-trap chamber (6, as modified by Furuhashi above), wherein the connecting tube is configured to allow blood from the air-trap chamber (6; as modified by Furuhashi above) to flow into the chamber (Fig. 2, as modified above); and Furuhashi discloses a liquid-level- adjusting tube (liquid level adjustment device, 11; abstract; [0073-0075]), Jansson and Furuhashi are silent in regard to the chamber member further comprising a hydrophobic filter; wherein the hydrophobic filter is configured to block liquid from flowing therethrough but allow gas to flow therethrough.
However, Kell discloses a chamber member further comprising a hydrophobic filter (microporous vent, 40); wherein the hydrophobic filter (40) is configured to block liquid from flowing therethrough but allow gas to flow therethrough (col. 5, lines 46-62).
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 chamber disclosed by Jansson in view of Furuhashi to include a hydrophobic filter, similar to that disclosed by Kell, in order to vent and permit permeation of air, or gas, through the thin layer of material and concurrently prevent the migration of blood or other aqueous liquid through the layer under pressures encountered during normal or abnormal conditions of use, as suggested by Kell in column 5, lines 46-62.
14. Claim(s) 13 is rejected under 35 U.S.C. 103 as being unpatentable over Jansson in view of Furuhashi, as applied to claim 1 above, and further in view of Fresnius Medical et al. (DE 10 2005001779 A1).
15. With regard to claim 13, while Jansson discloses a delivery-amount-detecting unit (detecting device, 20), Jansson and Furuhashi are silent in regard to the delivery-amount- detecting unit being further configured to detect a stroke volume of liquid with reference to a number of revolutions of a rotor of the blood pump.
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); including a delivery-amount-detecting unit being further configured to detect a stroke volume of liquid with reference to a number of revolutions of a rotor of the blood pump ([0008]; [0011]; [0014]; [0047]).
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 delivery-amount-detecting unit disclosed by Jansson in view of Furuhashi to be configured to detect stroke volume of liquid, similar to that disclosed by Fresnius, in order for measured pressure and the known system volumes to be calculated at any time; if the desired stroke volume is reached, it is switched to the venous phase; the blood pump is stopped, the venous hose clamp is opened, and blood is conveyed to the patient by the overpressure in the system; the air pump can in turn be used to control the pressure so that the delivery rate of the blood can be optimally adjusted, as suggested by Fresnius in paragraph [0047].
Conclusion
16. 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.
17. 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..
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, 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
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