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 Arguments
Applicant’s amendment filed 07/24/2026 is accepted and entered. Applicant’s amendments to the claims have overcome the previous 112 rejections and the previous 112 rejections have been withdrawn.
Applicant’s arguments, see pages 10-14, filed 07/24/2026, with respect to the rejection(s) of claim(s) 22 under USC 103 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 Therefore, the rejection has been withdrawn.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 a different interpretation of the claims and Utterberg, as set forth below.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 29 and 33 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding Claim 29, it is unclear if the limitation “a second withdrawal valve” is intended to refer to the same “a second withdrawal valve” as that recited in Claim 22 or if this recitation of “a second withdrawal valve” is intended to refer to a different withdrawal valve (i.e. a third withdrawal valve). Claim 33 is also rejected based on its dependency on Claim 29.
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) 22-34 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Utterberg et al (US 2007/0010779).
Regarding Claim 22, Utterberg discloses a fluid diverting device (43, Fig. 1) for an apparatus for extracorporeal treatment of blood (Fig. 1), the apparatus comprising:
a blood treatment unit (30, Fig. 1);
an extracorporeal blood circuit (Fig. 1) coupled to the blood treatment unit (30, Fig. 1) and comprising a blood withdrawal line (14, Fig. 1) and a blood return line (34, Fig. 1) connectable to a vascular access (12 and 36, Fig. 1) of a patient; and
a blood pump (22, Fig. 1) configured to be coupled to a pump section (20, Fig. 1) of the extracorporeal blood circuit (Fig. 1),
wherein the fluid diverting device (43, Fig. 1) comprises:
a substantially H-shaped conduit assembly (¶ [0036]) comprising a withdrawal conduit (14a, Fig. 1), a return conduit (34a, Fig. 1), and at least one bridging conduit (44, Fig. 1) connecting or configured to connect the withdrawal conduit (14a, Fig. 1) to the return conduit (34a, Fig. 1; ¶ [0036]),
wherein the withdrawal conduit is connected or connectable upstream and downstream to the withdrawal line (14, Fig. 1), and
wherein the return conduit (34a, Fig. 1) is connected or connectable upstream and downstream to the return line (34, Fig. 1); and
a plurality of distributors (46 and 48, Fig. 1) operating on the withdrawal conduit (14a, Fig. 1), on the return conduit (34a, Fig. 1), and on the at least one bridging conduit (44, Fig. 1),
wherein the plurality of distributors (46 and 48, Fig. 1) are configured to divert a flow of liquid and/or blood without disconnecting the patient (¶ [0036-0038]).
Since the claim does not explicitly require a plurality of valves, but initially provides the option between a plurality of valves or distributors, the limitations regarding the plurality of valves comprising a withdrawal valve, a return valve, a bridging valve, and the locations of these valves are considered to be disclosed by Utterberg since Utterberg discloses the plurality of distributors.
Regarding Claim 23, Utterberg discloses the withdrawal conduit (14a, Fig. 1) is substantially parallel (¶ [0036]) to the return conduit (34a, Fig. 1) and wherein the bridging conduit (44, Fig. 1) is at least in part transverse (¶ [0036]) to the withdrawal conduit (14a, Fig. 1) and to the return conduit (34a, Fig. 1).
Regarding Claim 24, Utterberg discloses at least one of the withdrawal conduit (14a, Fig. 1), the return conduit (34a, Fig. 1), or the bridging conduit (44, Fig. 1) is at least in part straight (¶ [0036], Fig. 1).
Regarding Claims 25, Claim 22 from which Claim 25 depends does not explicitly require a plurality of valves. Thus, such limitations of Claim 25 regarding the return valve being placed downstream of a junction between the bridging conduit and the return conduit, with respect to a flow of blood during treatment is disclosed by Utterberg as Utterberg discloses the distributors of Claim 22.
Regarding Claims 26, Claim 22 from which Claim 26 depends does not explicitly require a plurality of valves. Thus, such limitations of Claim 26 regarding the bridging valve comprises a first bridging valve and a second bridging valve operating on the bridging conduit, and wherein the first bridging valve is placed closed to the return conduit and the second bridging valve is placed closer to the withdrawal conduit is disclosed by Utterberg as Utterberg discloses the distributors of Claim 22.
Regarding Claim 27, Utterberg discloses a liquid source (28, Fig. 1; ¶ [0032]) connected or connectable to the access point (¶ [0032]; the liquid source is connectable to the blood circuit). Claim 22 from which Claim 27 depends does not explicitly require a plurality of valves. Thus, such limitations of Claim 27 regarding the bridging conduit has an access point located between the first bridging valve and the second bridging valve is disclosed by Utterberg as Utterberg discloses the distributors of Claim 22.
Regarding Claim 28, Utterberg discloses a holder (43, Fig. 1; ¶ [0048]; the assembly will have some sort of housing or plate to hold the various conduits and valves together) configured to hold the substantially H-shaped conduit assembly. Claim 22 from which Claim 28 depends does not explicitly require a plurality of valves. Thus, such limitations of Claim 28 regarding the holder configured to hold the plurality of valves is disclosed by Utterberg as Utterberg discloses the distributors of Claim 22.
Regarding Claim 29, Claim 22 from which Claim 29 depends does not explicitly require a plurality of valves. Thus, such limitations of Claim 29 regarding the plurality of valves are configured to be arranged in a treatment configuration, in which the first withdrawal valve, a second withdrawal valve, and the return valve are open and the bridging valve is closed, to perform treatment of the patient is disclosed by Utterberg as Utterberg discloses the distributors of Claim 22.
Regarding Claim 30, Claim 22 from which Claim 30 depends does not explicitly require a plurality of valves. Thus, such limitations of Claim 30 regarding the plurality of valves are configured to be arranged in a recirculation configuration, in which the return valve is closed, the first withdrawal valve is closed, the second withdrawal valve is open, and the bridging valve is open, so that blood or liquid recirculates in the blood treatment unit of the apparatus without disconnecting the patient is disclosed by Utterberg as Utterberg discloses the distributors of Claim 22.
Regarding Claim 31, Claim 22 from which Claim 31 depends does not explicitly require a plurality of valves. Thus, such limitations of Claim 31 regarding the plurality of valves are configured to be arranged in a return branch flushing configuration, in which the first bridging valve is open, the second bridging valve is closed, and the liquid source is connected to the access point to inject liquid and flush a branch of the return conduit placed downstream a junction of the bridging conduit to the return conduit is disclosed by Utterberg as Utterberg discloses the distributors of Claim 22.
Regarding Claim 32, Claim 22 from which Claim 32 depends does not explicitly require a plurality of valves. Thus, such limitations of Claim 32 regarding the plurality of valves are configured to be arranged in a withdrawal branch flushing configuration, in which the first bridging valve is closed, the second bridging valve is open, the second withdrawal valve is closed and the liquid source is connected to the access point to inject liquid and flush a branch of the withdrawal conduit placed upstream of a junction between the bridging conduit and the withdrawal conduit is disclosed by Utterberg as Utterberg discloses the distributors of Claim 22.
Regarding Claim 33, Claim 22 from which Claim 33 depends does not explicitly require a plurality of valves. Thus, such limitations of Claim 33 regarding the valves of the plurality of valves are operatively connected or connectable to a control unit of one or both of the apparatus for extracorporeal treatment of blood or the fluid diverting device, and wherein the control unit is configured for commanding the configurations of the plurality of valves is disclosed by Utterberg as Utterberg discloses the distributors of Claim 22.
Regarding Claim 34, Claim 22 from which Claim 34 depends does not explicitly require a plurality of valves. Thus, such limitations of Claim 34 regarding the at least one of the plurality of valves is a rotating clamp, and wherein the rotating clamp comprises a rotating body and an abutment element is disclosed by Utterberg as Utterberg discloses the distributors of Claim 22.
Claim(s) 35 is/are rejected under 35 U.S.C. 103 as being unpatentable over Utterberg et al (US 2007/0010779 in view of Delnevo et al (US 2005/0011823).
Regarding Claim 35, Utterberg is silent whether at least one infusion line is connected to the access point, and wherein an infusion fluid container is connected to the infusion line and an infusion pump operates on the infusion line.
Delnevo teaches an extracorporeal blood circuit, thus being in the same field of endeavor, with an infusion line (6, Fig. 1) connected to an access point (26, Fig. 1), and wherein an infusion fluid container (7, Fig. 1) is connected to the infusion line (6, Fig. 1) and an infusion pump (13, Fig. 1) operates on the infusion line (6, Fig. 1; ¶ [0074-0078]). This allows fluid to be infused into the blood circuit and therefore into the patient.
Therefore, it would have been obvious to modify the device of Utterberg to include an infusion line connected to the access point, and wherein an infusion fluid container is connected to the infusion line and an infusion pump operates on the infusion line, as taught by Delnevo, to allow fluid to be infused into the blood circuit and therefore into the patient.
Claim(s) 36 is/are rejected under 35 U.S.C. 103 as being unpatentable over Utterberg et al (US 2007/0010779) in view of Sakamoto et al (US 2013/0150768).
Regarding Claim 36, Utterberg is silent regarding an auxiliary bridging conduit connecting or configured to connect the withdrawal conduit to the return conduit and arranged in parallel with respect to the bridging conduit; and an auxiliary pump operating on the auxiliary bridging conduit.
Sakamoto teaches an extracorporeal blood circuit, thus being in the same field of endeavor, with an auxiliary bridging conduit (L6, Fig. 1) arranged in parallel with respect to the bridging conduit (L7, Fig. 1), and an auxiliary pump (6, Fig. 1) operating on the auxiliary bridging conduit (L6, Fig. 1) to allow positive or negative pressure to be applied to the blood circuit easily (¶ [0090]).
Therefore, it would have been obvious to modify the device of Utterberg to include an auxiliary bridging conduit connecting the withdrawal conduit to the return conduit and arranged in parallel with respect to the bridging conduit, and an auxiliary pump operating on the auxiliary bridging conduit, as taught by Sakamoto, to allow positive or negative pressure to be applied to the blood circuit easily (as motivated by Sakamoto ¶ [0090]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jessica Arble whose telephone number is (571)272-0544. The examiner can normally be reached Mon - Fri 9 AM - 5 PM.
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.
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.
/JESSICA ARBLE/ Primary Examiner, Art Unit 3781
