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 .
Election/Restrictions
Applicant’s election without traverse of claims 30-49 in the reply filed on 10/10/2025 is acknowledged. Accordingly, claims 50-56 are withdrawn from further consideration pursuant to 37 CFR 1.142 (b) as being drawn to a non-elected invention
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.
Claim 40 is 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.
Claim 40 recites the limitation "outlet of the secondary chamber" and “inlet of the secondary chamber” in lines 2 and 3. There is insufficient antecedent basis for these limitations in the claim.
Claim 47 recited the limitation “the inlet” and the limitation “the outlet” in lines 4 and 5. There is insufficient antecedent basis for these limitations in the claim.
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.
Claims 30-49 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by
Weitzel et al. WO 00/64510.
As to claim 30, Weitzel teaches a disposable circuit for extracorporeal treatment of blood comprising (page 7, lines 3-4):
- a filtration unit 300, 48;
- a blood circuit comprising a blood withdrawal line 58 having a first end connected to an inlet of the filtration unit 48 , and
a blood return line 72 having a first end connected to an outlet of the filtration unit 48, the blood withdrawal line 58 and the blood return line 72 configured to connect to a patient cardiovascular system (Fig. 4),
wherein the blood withdrawal line 58 has a second end provided with an arterial connector 190 and the blood return line 72 has a second end provided with a venous connector 192, the arterial connector and the venous connector configured to detachably connect to a vascular access device of a patient (Fig. 4); and
wherein the blood circuit is configured to interface with a blood pump 52 to control flow in the blood circuit 58 (Fig. 4; page 7, lines 8-10);
- at least one fluid line 70 connected to the blood circuit (Fig. 4),
- a first auxiliary connector 42 arranged either on the blood circuit or on the at least one fluid line (Fig. 4), the first auxiliary connector 42 configured to removably connect with one of the arterial connector 190 and the venous connector 192 in a recirculation configuration to define a closed circuit allowing fluid recirculation in the blood circuit (Fig. 4)
- a second auxiliary connector 44 arranged on the blood circuit or on the at least one fluid line 70, wherein the first auxiliary connector 42 and the second auxiliary connector 44 are configured to be removably connected one with the arterial connector and the other with the venous connector to define the closed circuit (Fig. 4; page 20, lines 1-6).
As to claim 31, Weitzel teaches a disposable circuit for extracorporeal treatment of blood comprising:
- a filtration unit 48;
- a blood circuit comprising a blood withdrawal line 58 having a first end connected to an inlet of the filtration unit 48, and a blood return line 72 having a first end connected to an outlet of the filtration unit 48, the blood withdrawal line 58 and the blood return line 50 configured to connect to a patient cardiovascular system (Fig. 4), wherein the blood withdrawal line 58 has a second end provided with an arterial connector 190 and the blood return line 72 has a second end provided with a venous connector 192, the arterial connector and the venous connector configured to detachably connect to a vascular access device of a patient; and wherein the blood circuit is configured to interface with a blood pump to control flow in the blood circuit;
- a first auxiliary connector 42 arranged on the blood circuit, the first auxiliary connector configured to removably connect with one of the arterial connector and the venous connector in a recirculation configuration to define a closed circuit allowing fluid recirculation in the blood circuit;
- a second auxiliary connector 44 arranged on the blood circuit, and wherein the first auxiliary connector and the second auxiliary connector are configured to be removably connected one with the arterial connector and the other with the venous connector to define the closed circuit (Fig. 4).
As to claim 32, Weitzel teaches the disposable circuit is reversibly configurable between a treatment configuration in which the arterial connector and the venous connector are removably connected to the vascular access device of a patient and blood is withdrawn from the patient through the blood withdrawal line, circulated through the filtration unit and returned to the patient through the blood return line; and a recirculation configuration in which the arterial connector and the venous connector are removably connected to the first auxiliary connector and the second auxiliary connector, wherein in the recirculation configuration a fluid contained in the blood circuit is recirculated inside the disposable circuit (page 6, lines 5-10 ).
As to claim 33, Weitzel teaches both the first auxiliary connector 42 and the second auxiliary connector 44 comprise three ports including a disconnectable port configured to be connected to one connector selected among the venous connector and the arterial connector (Fig. 4);
wherein both the first auxiliary connector 42 and the second auxiliary connector 44 are provided with:
- a first and a second non-disconnectable service port fixed to respective tube portions, 88, 90; - the disconnectable port (Fig. 2 and 4).
As to claim 34, at least one fluid line comprises one or more of the following lines:
- a post-blood pump (after pump 4, Fig. 4) pre-dilution infusion line 88 directly connected to the blood withdrawal line 58 (Fig. 2 and 4);
- a pre-blood pump pre-dilution infusion line 54 directly connected to the blood withdrawal line (Fig. 2);
- a post-dilution fluid line 90 directly connected to the blood return line 72 (Fig. 2); wherein the first auxiliary connector 42 comprises a first and a second non-disconnectable service port fixed to a respective tube portion of the fluid line at which the first auxiliary connector 42 (Fig. 4) is arranged.
As to claim 35, the second auxiliary connector 44 comprises a first and a second non-disconnectable service port fixed to a respective tube portion 2 of the fluid line at which the second auxiliary connector is arranged, the first auxiliary connector 42 and the second auxiliary connector 44 being fixed to the same fluid line 2 (Fig. 1, 2, and 4).
As to claim 36, Weitzel teaches a pre-blood pump pre-dilution infusion line 54 directly connected to the blood withdrawal line 58 and wherein the first auxiliary connector 42 and the second auxiliary connector 44 are fixed to the pre-blood pump pre-dilution infusion line (44 via shunt 2), wherein in the recirculation configuration the first auxiliary connector fixed on the pre-blood pump pre-dilution infusion line 54 is connected to the arterial connector 190 and the second auxiliary connector 44 fixed on the pre-blood pump pre-dilution infusion 54 line is connected to the venous connector 192 (Fig. 2 and 4).
As to claim 37, the first auxiliary connector 42 is arranged on the pre-blood pump pre-dilution infusion line 54 downstream the second auxiliary connector 44 (Fig. 2).
As to claim 38, Weitzel teaches a pre-blood pump pre-dilution infusion line 54 configured to allow fluid administration to the blood circuit downstream the arterial connector; the pre-blood pump pre-dilution infusion line 54 comprising a peristaltic pump tract configured to be coupled with a corresponding peristaltic pump 30 and a container 28, the pre-blood pump pre-dilution infusion line 54 being connected to the container, the first auxiliary connector 42 and the second auxiliary connector 44 being connected to the pre-blood pump pre-dilution infusion line downstream from the peristaltic pump tract (Fig. 2).
As to claim 39, Weitzel teaches the disposable circuit of claim 30, comprising a first pressure drop valve 26 or flow resistor configured to even fluid flow distribution during recirculation, the first pressure drop valve 26 or flow resistor being arranged on the blood circuit or on the at least one fluid line 88, the first pressure drop valve or flow resistor configured to even respective fluid flow resistances of two connected branch tube portions during recirculation, wherein the first pressure drop valve 26 or flow resistor 14 is arranged in one of the two connected branch tube portions comprising a portion of the fluid line and a portion of the blood circuit (Fig. 2 and 4; page 10, lines 10-24).
As to claim 40, Weitzel teaches the disposable circuit of claim 30, further comprising:
- an effluent fluid line 22 connected to an outlet of the secondary chamber 20/152 (Fig. 2 and 3; page 9, lines 5-6; page 11, lines 4-14), and
- a dialysis fluid line 24 connected to the inlet of the secondary chamber 20/152, the disposable circuit being a continuous renal replacement therapy (CRRT) disposable circuit (Fig. 2 and 3).
As to claim 41, the first auxiliary connector 42 and the second auxiliary connector 44 are arranged on the blood circuit, wherein in the recirculation configuration, the first auxiliary connector 42 arranged on the blood return line72 is connected to the arterial connector 190 and the second auxiliary connector 44 arranged on the blood withdrawal line 58 is connected to the venous connector 192.
As to claim 42, both the first auxiliary connector and the second auxiliary connector comprise a disconnectable port configured to be connected to a corresponding disconnectable port of either the venous connector or the arterial connector 190 (Fig. 4 element 190 adjacent connectors 42, 44).
As to claim 43, both the first auxiliary connector 42 and the second auxiliary connector 44 comprise three ports including a disconnectable port configured to be connected to a disconnectable 190 (adjacent connectors 42, 44) port the venous connector or the arterial connector (Fig. 4).
As to claim 44, the disconnectable port of the first auxiliary connector and the disconnectable port of the arterial connector or of the venous connector are either a first - male - type or a second - female - type, the first - male - type being configured to introduce into the second - female – type;
- both the arterial connector and the venous connector are connectors provided with a disconnectable port of the first - male - type, or
- both the arterial connector and the venous connector are provided with a disconnectable port of the second - female – type (page 14, lines 18-21).
As to claim 45, the first auxiliary connector and the second auxiliary connector comprise the detachable port both of the first - male -- type or both of the second - female – type (page 14, lines 18-21.
As to claim 46, the first auxiliary connector 42 and the second auxiliary connector 44 (via shunt 2) are installed on the infusion line 54, one of the first auxiliary connector 42 and the second auxiliary connector 44 upstream with respect to the other on the infusion line, the infusion line comprising a fluid pump tract 30 on which a fluid pump operates, the first auxiliary connector and the second auxiliary connector being installed on the infusion line downstream the fluid pump tract (Fig. 2 and 4).
As to claim 47, Weitzel teaches the disposable circuit of claim 30, being a continuous renal replacement therapy (CRRT) disposable circuit configured for use in a renal failure apparatus for extracorporeal treatment of blood in the acute field, the filtration unit 20 comprising a primary chamber 152 connected to the blood circuit using the inlet 144 and the outlet 146 and a secondary chamber 152 separated from the primary chamber by a semi-permeable membrane – where Weitzel teaches the cartridge 20 comprises a plurality of membranes which are hollow fibers 152, the first and second chambers are the lumens 140 of the fibers 152 (Fig. 3; page 11, lines 4-14), the continuous renal replacement therapy (CRRT) disposable circuit comprising a disposable dialysis fluid line irremovably connected to an inlet of the secondary chamber of the filtration unit and a disposable effluent line irremovably connected to an outlet of the secondary chamber of the filtration unit (Fig. 3). Weitzel teaches combining fluids in a chamber with a first inlet and outlet and a second inlet and outlet, the chamber having a plurality of conduits, each having a membrane (page 4, lines 16-24).
As to claim 48, in the recirculation configuration fluid flows from the arterial connector 190 through the filtration unit 48 to the venous connector 192, from the venous connector 192 to the second auxiliary 44 connector and from the second auxiliary connector 44 to the first auxiliary connector 42 and from the first auxiliary connector 42 to the arterial connector 190 (Fig. 4).
As to claim 49, the first auxiliary connector 42 and the second auxiliary connector 44 are separate connectors (Fig. 4).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Carpenter et al. US 2005/0063860 is cited to show disposable circuits for extracorporeal blood treatments.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JACQUELINE F STEPHENS whose telephone number is (571)272-4937. The examiner can normally be reached 8:30-5:00.
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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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/JACQUELINE F STEPHENS/ Primary Examiner, Art Unit 3781