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 .
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 –3
(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 1-4, 6-7, 12, 14, 16, and 18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Shmulewitz (US 2001/0027287).
Regarding claim 1, Shmulewitz discloses a system (e.g. as shown in Figure 1), comprising:
an intravascular reperfusion therapy device configured to be positioned within a coronary vein of a patient to deliver reperfusion therapy to a myocardium of a heart of the patient associated with the coronary vein (e.g. device 10), wherein the intravascular reperfusion therapy device comprises
a sensor (e.g. flow probe disposed on conduit 30 as disclosed in [0048]);
a pump (e.g. pump 12), and
a catheter comprising a lumen (e.g. conduit 30 including lumen 33),
wherein the intravascular reperfusion therapy device is configured to, using the pump, direct flow of a fluid through the lumen to deliver the reperfusion therapy (e.g. abstract); and
a processor circuit (e.g. control circuitry 14) communication with the intravascular reperfusion therapy device and configured to:
receive, from the sensor, physiological data associated with blood flow through the coronary vein (e.g. data regarding pressure and flow rate as disclosed in [0048]);
determine, based on the physiological data, a progression of the reperfusion therapy delivered to the myocardium of the heart (e.g. flow probe that measures the pressures and as describe in [0048]).
control, based on the progression of the reperfusion therapy, the flow of the fluid through the lumen such that the reperfusion therapy is controlled (e.g. controlling the pump as disclosed in [0047] – [0048]).
Regarding claim 2, Shmulewitz additionally discloses wherein, to control the flow of the fluid through the lumen, the processor circuit is configured to control, via the pump, a flow rate of the flow of the fluid through the lumen (e.g. control of the flow rate as disclosed in [0048]).
Regarding claim 3, Shmulewitz additionally discloses wherein, to control the flow of the fluid through the lumen, the processor circuit is configured to control, via the pump, a direction of the flow of the fluid through the lumen (e.g. the fluid is either not traveling at all, or traveling from the conduit to the coronary vein).
Regarding claim 4, Shmulewitz additionally discloses wherein, to control the direction of the flow of the fluid through the lumen, the processor circuit is configured to control the intravascular reperfusion therapy device to, using the pump deliver the fluid from the lumen to the coronary vein to generate a back pressure in a first direction, wherein the first direction is opposite a second direction of the blood flow through the coronary vein (e.g. flow as taught in [0048], wherein the blood will necessarily create the back pressure as required by the claim).
Regarding claim 6, Shmulewitz additionally discloses wherein the intravascular reperfusion therapy device is further configured to control a temperature of the fluid to deliver the reperfusion therapy, wherein, based on the progression of the reperfusion therapy, the processor circuit is further configured to: control the intravascular reperfusion therapy device to control the temperature of the fluid such that temperature of the myocardium is controlled (e.g. control of the temperature of the fluid circuit as disclosed in [0040]).
Regarding claim 7, Shmulewitz additionally discloses wherein the intravascular reperfusion therapy device is further configured to control an oxygen saturation level in the fluid to deliver the reperfusion therapy, wherein, based on the progression of the reperfusion therapy, the processor circuit is further configured to: control the intravascular reperfusion therapy device to control the oxygen saturation level in the fluid (e.g. the reperfusion uses oxygenated blood and thus the oxygen saturation level is necessarily controlled).
Regarding claim 12, Shmulewitz additionally discloses wherein the sensor is positioned at a distal portion of the catheter (e.g. flow probe disposed on conduit 30 as disclosed in [0048], wherein the flow probe will necessarily be “distal” to the end of the conduit’s connection to pump 12 which is outside of the patient’s heart);
Regarding claim 14, Shmulewitz additionally discloses wherein the fluid comprises at blood (e.g. oxygenated blood as disclosed in [0001]).
Regarding claim 16, Shmulewitz additionally discloses wherein the sensor comprises a flow sensor, wherein the physiological data comprises a blood flow rate (e.g. flow probe disposed on conduit 30 as disclosed in [0048]).
Regarding claim 18, Shmulewitz discloses a system, comprising:
an intravascular reperfusion therapy device configured to be positioned within a coronary vein of a patient to deliver reperfusion therapy to a myocardium of a heart of the patient associated with the coronary vein, wherein the intravascular reperfusion therapy device comprises:
a catheter comprising a lumen (e.g. conduit 30 including lumen 33),
a flow sensor positioned at a distal portion of the catheter (e.g. flow probe disposed on conduit 30 as disclosed in [0048]); and
a pump in fluid communication with the lumen (e.g. pump 12),
wherein the intravascular reperfusion therapy device is configured to deliver the reperfusion therapy by, using the pump, directing flow of a fluid through the lumen to the coronary vein in a first direction to generate back pressure in an opposite, second direction within the coronary vein (e.g. flow as taught in [0048]); and
a processor circuit in communication with the intravascular reperfusion therapy device and configured to:
receive, from the flow sensor, flow data associated with blood flow through the coronary vein (e.g. data regarding pressure and flow rate as disclosed in [0048]);;
determine, based on the flow data, a progression of the reperfusion therapy delivered to the myocardium of the heart; and
control, based on the progression of the reperfusion therapy, the flow of the fluid through the lumen such that the back pressure within the coronary vein is controlled. (e.g. controlling the pump as disclosed in [0047] – [0048]).
Claim Rejections - 35 USC § 103
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.
Claims 11, 13, 15, and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Shmulewitz.
Regarding claim 11, Shmulewitz (the embodiment in Figure 1) but does not expressly disclose a pump that is external to the patient. Shmulewitz does disclose in a separate embodiment (the embodiment of Figure 6) that a pump can be positioned external to the patient (e.g. external hydraulically-actuated pump 100). It would have been obvious to one having ordinary skill in the art at the time the invention was made to use the Figure 6 external pump in the Figure 1 embodiment of Shmulewitz since such a modification would provide the system with the predictable results of a greater flexibility and a reliable means of using a pump most suitable for a patient’s particular situation.
Regarding claim 13, Shmulewitz (embodiment of Figure 1) discloses the claimed invention except the express mention of an additional sensor. The embodiment of Figure 11 in Shmulewitz additionally discloses an additional sensor (e.g. sensor 165), wherein the processor circuit is further configured to receive, from the additional sensor, additional physiological data associated with blood flow through the coronary vein, wherein the processor circuit is configured to determine the progression of the reperfusion therapy further based on the additional physiological data (e.g. use of sensor 165 to measure flow, pressure or other types of data as disclosed in [0076]). It would have been obvious to one having ordinary skill in the art to include the additional sensor of the Figure 11 embodiment in the device of the Figure 1 embodiment in order to provide the system with the predictable results of a reliable means of measuring physiological data.
Regarding claim 15, Shmulewitz additionally discloses wherein the processor circuit is further configured to output, to display in communication with the processor circuit, a visual representation of the progression of the reperfusion therapy (e.g. use of input pad or keyboard as disclosed in [0053] will necessarily require some sort of display to display a representation of the values inputted by the clinician). While not expressly disclosed, it would be obvious for the display to disclose a visual representation of the progression of the reperfusion, as any data related to the output will be considered a representation of the progression of the reperfusion therapy. It would have been obvious to one having ordinary skill in the art at the time the invention was made to include a visual representation of the progression of the reperfusion therapy in the display device of Shmulewitz since it will provide the predictable results of a reliable means of displaying information.
Regarding claim 17, as disclosed in claim 13, the embodiment of Figure 11 in Shmulewitz additionally discloses wherein the sensor comprises a pressure sensor, wherein the physiological data comprises pressure data (e.g. use of sensor 165 to measure flow, pressure or other types of data as disclosed in [0076]).
Claims 8-10 are rejected under 35 U.S.C. 103 as being unpatentable over Shmulewitz in view of Farnan (US 2009/0171137).
Regarding claims 8-10, Shmulewitz discloses the claimed invention except the express mention of a pump is coupled to the catheter and is configured to be positioned within a blood vessel of the patient, a first port proximal of the pump and a second port distal of the pump, wherein the first port, the second port, and the pump are in fluid communication with the lumen and a device configured to control the pump to intake the fluid via the first port and output the fluid via the second port such that the fluid flows through the lumen in a first direction; or intake the fluid via the second port and output the fluid via the first port such that the fluid flows through the lumen in a different, second direction. Farnan discloses that the use of such pumps located in a blood vessel is well known in the art (e.g. placement of device as shown in Figure 1). It would have been obvious to one having ordinary skill in the art to include the inline blood pump of Farnan in the device of Shmulewitz since such a modification would provide the system with the predictable results of more reliable pump ([0004] of Farnan).
Allowable Subject Matter
Claim 5 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: The prior art of record does not disclose a system wherein the pump oscillates a direction of the flow of the fluid through the lumen between a first direction and a different, second direction in combination with the other elements of the claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Amanda K Hulbert whose telephone number is (571)270-1912. The examiner can normally be reached Monday - Friday 9:00-5:00.
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, Unsu Jung can be reached at 571-272-8506. 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.
/Amanda K Hulbert/Primary Examiner, Art Unit 3792