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 .
Status of Claims
Claims 1-5 and 7-9 are pending and currently under consideration for patentability.
Claim 6 and 10-13 are cancelled.
Response to Arguments
Applicant's arguments filed 4/13/2026 have been fully considered but they are not persuasive.
In response to the applicant’s argument of the pump of Sohn, and 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). In this case the new pump of Corbett would replace the pump of Sohn.
In response to the applicant’s argument regarding ctc cells, the case law used is common, and the ctc cells are not part of the invention, and in fact would trigger a new rejection if they were to hold patentable weight: Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
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) 1 and 2 are rejected under 35 U.S.C. 103 as being unpatentable over Sohn (WO 9529716 A1) in view of Corbett (US 20150328383 A1).
Regarding Claim 1, Sohn teaches a device for comminution or inactivation of circulating tumor cells (CTC) or tumor cell clusters (CTCC) from a tumor-affected organ or organ part, comprising:
a pump (110) arranged inside an outer jacket tube (111) having a form factor configured for intracorporeal placement in a venous drain of the tumor-affected organ or organ part and venous blood flow between an inlet and a pump outlet(page 10, lines 14-30), which has a pressure-increasing section and a pressure- reducing throttle (116) arranged at the pump outlet, and corresponds on the output side in its design point given by volumetric flow (Q) and pumping pressure (p) to the volumetric flow and the blood pressure of the venous drain of the tumor-affected organ or organ part (claims 8-9), the combination of the pressure-increasing section (118) and the pressure-reducing throttle (116) at the pump outlet configured for providing shear stress on the venous blood flow effective for comminution or inactivation of CTCs and CTCCs, wherein the pump (110) comprises a micro-axial pump with a sequence of pressure-increasing blades arranged along a screw shaft of the micro-axial pump rotatable in the outer jacket tube (111) by a drive(page 10, lines 14-30), and the pressure-reducing throttle comprises a flow resistance structure projecting radially from the screw shaft of the micro-axial pump (figure 17) (page 10, lines 14-30), which flow resistance structure has a cylindrical section which forms a circular-cylindrical annular gap with the outer jacket tube enclosing the pressure-reducing throttle, to allow selective control of both shear stress and pressure differential on the blood removed at the inlet and ejected at the pump outlet (page 10, lines 14-30) (claim 17, 22)
Sohn fails to explicitly teach inactivation of circulating tumor cells (CTC) or tumor cell clusters (CTCC) from a tumor-affected organ or organ part. It has been held that a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus satisfying the claimed structural limitations. Ex parte Masham, 2 USPQ2d 1647 (1987). In this case, the device of Sohn could easily be used for circulating tumor cells (CTC) or tumor cell clusters (CTCC) from a tumor-affected organ or organ part.
Sohn fails to explicitly teach wherein a coaxial, inner jacket tube which is fixed to the blades of the micro-axial pump is provided within the outer jacket tube. Corbett teaches a blood pump housing wherein a coaxial, inner jacket tube (801) which is fixed to the blades of the micro-axial pump is provided within the outer jacket tube (paragraph [0034]). Therefore, it would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to modify Sohn to include the pump of Corbett so the sizing minuscule and can fit in small places.
Regarding Claim 2, Sohn teaches the device according to claim 1. Sohn fails to teach wherein the volumetric flow of the pump in the design point is 0.1-1.5 liters/minute. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have the volumetric flow of the pump in the design point is 0.1-1.5 liters/minute in order to fit the particular procedure being done since this claimed dimension of the flow pump speed is non critical. Since applicant has not given any criticality to why the dimension disclosed has any importance to the function of the claimed device (see page 8, lines 23 of applicants specification), the Federal Circuit held that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device. In Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777.
Claim(s) 3-5, and 7-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sohn (WO 9529716 A1) in view of Corbett (US 20150328383 A1) in view of Nitzan (US 20160331378 A1).
Regarding Claim 3, Sohn teaches the device according to claim 1. However Sohn fails to teach wherein the pumping pressure of the pump is 4-20 hPa in the design point. In the same field of endeavor, Nitzan teaches wherein the pumping pressure of the pump is 4-20 hPa in the design point (paragraph [0104]). Therefore, it would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to modify Sohn wherein the pumping pressure of the pump is 4-20 hPa in the design point, similar to Nitzan, so the flow rate being adjustable can help the pump accommodate changes in the patient's condition over time and/or allow the pump to be driven at a selected rate for a particular patient (motivated by Nitzan, paragraph [0104]).
Regarding Claim 4, Sohn teaches the device according to claim 1. However Sohn fails to teach wherein before the pump and after the pressure-reducing throttle a respective pressure sensor is provided, and a control unit, which controls the pressure difference of the pressure values measured by the two pressure sensors to a predetermined setpoint value by varying the speed of the screw shaft.
Nitzan further teaches wherein before the pump and after the pressure-reducing throttle a respective pressure sensor (paragraph [0105]) is provided, and a control unit, which controls the pressure difference of the pressure values measured by the two pressure sensors to a predetermined setpoint value by varying the speed of the screw shaft (paragraph [0024], [0107]). Therefore, it would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the pressure reducing throttle of Sohn, wherein before the pump and after the pressure-reducing throttle a respective pressure sensor is provided, and a control unit, which controls the pressure difference of the pressure values measured by the two pressure sensors to a predetermined setpoint value by varying the speed of the screw shaft, similar to Nitzan, can detect if the system is working as intended or if there is a medical issue.
Regarding Claim 5, Sohn in view of Nitzan teaches the device according to claim 4. However Sohn fails to teach wherein the setpoint value predetermined for the pressure difference is 0. Nitzan further teaches wherein the setpoint value predetermined for the pressure difference is 0 (paragraph [0112]). Therefore, it would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to modify wherein the setpoint value predetermined for the pressure difference is 0, similar to Nitzan, so the flow is not disturbed by a change in pressure (motivated by Nitzan, paragraph [0112]). Therefore, it would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the pressure reducing throttle of Sohn, wherein before the pump and after the pressure-reducing throttle a respective pressure sensor is provided, and a control unit, which controls the pressure difference of the pressure values measured by the two pressure sensors to a predetermined setpoint value by varying the speed of the screw shaft, similar to Nitzan, can detect if the system is working as intended or if there is a medical issue.
Regarding Claim 7, Sohn teaches the device according to claim 2. However Sohn fails to teach wherein the pumping pressure of the pump is 4-20 hPa in the design point. In the same field of endeavor, Nitzan teaches wherein the pumping pressure of the pump is 4-20 hPa in the design point (paragraph [0104]). Therefore, it would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to modify Sohn wherein the pumping pressure of the pump is 4-20 hPa in the design point, similar to Nitzan, so the flow rate being adjustable can help the pump accommodate changes in the patient's condition over time and/or allow the pump to be driven at a selected rate for a particular patient (motivated by Nitzan, paragraph [0104]).
Regarding Claim 8, Sohn teaches the device according to claim 2. However Sohn fails to teach wherein before the pump and after the pressure-reducing throttle a respective pressure sensor is provided, and a control unit, which controls the pressure difference of the pressure values measured by the two pressure sensors to a predetermined setpoint value by varying the speed of the screw shaft.
Nitzan further teaches wherein before the pump and after the pressure-reducing throttle a respective pressure sensor (paragraph [0112]) is provided, and a control unit (9), which controls the pressure difference of the pressure values measured by the two pressure sensors to a predetermined setpoint value by varying the speed of the screw shaft (102) (paragraph [0104- 0105]). Therefore, it would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the pressure reducing throttle of Sohn, wherein before the pump and after the pressure-reducing throttle a respective pressure sensor is provided, and a control unit, which controls the pressure difference of the pressure values measured by the two pressure sensors to a predetermined setpoint value by varying the speed of the screw shaft, similar to Nitzan, can detect if the system is working as intended or if there is a medical issue.
Regarding Claim 9, Sohn in view of Nitzan teaches the device according to claim 3. However Sohn fails to teach wherein before the pump and after the pressure-reducing throttle a respective pressure sensor is provided, and a control unit, which controls the pressure difference of the pressure values measured by the two pressure sensors to a predetermined setpoint value by varying the speed of the screw shaft.
Nitzan further teaches wherein before the pump and after the pressure-reducing throttle a respective pressure sensor is provided, and a control unit (9), which controls the pressure difference of the pressure values measured by the two pressure sensors to a predetermined setpoint value by varying the speed of the screw shaft (102) (paragraph [0104- 0105]). Therefore, it would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the pressure reducing throttle of Sohn, wherein before the pump and after the pressure-reducing throttle a respective pressure sensor is provided, and a control unit, which controls the pressure difference of the pressure values measured by the two pressure sensors to a predetermined setpoint value by varying the speed of the screw shaft, similar to Nitzan, can detect if the system is working as intended or if there is a medical issue.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATE ELIZABETH STRACHAN whose telephone number is (571)272-7291. The examiner can normally be reached M-F: 8:00-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Rebecca Eisenberg can be reached on (571)-270-5879. The fax phone number for the organization where this application or proceeding is assigned is (571)-270-5879.
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/KATE ELIZABETH STRACHAN/ Examiner, Art Unit 3781
/REBECCA E EISENBERG/Supervisory Patent Examiner, Art Unit 3781
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