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 § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-13, and 18 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The claims recite determining a progression of a reperfusion therapy, and presenting the results.
The limitations of receiving a first and second external imaging data, as drafted, are processes that, under its broadest reasonable interpretation, covers gathering information but for the recitation of generic computer components. That is, other than reciting “a processor circuit”, nothing in the claim element precludes the step from practically being performed in the mind. For example, but for the “a processor circuit” language, “receiving” in the context of this claim encompasses the user visually obtaining images. Similarly, the limitation of determining a first and second measurements, are processes that, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components. For example, but for the “a processor circuit” language, “measurement” in the context of this claim encompasses the user calculating visually and manually the measurement. Furthermore, determining a progression of a reperfusion can be easily performed with a mental calculation of the user. If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components, then it falls within the “Mental Processes” grouping of abstract ideas. Accordingly, the claim recites an abstract idea.
This judicial exception is not integrated into a practical application. In particular, the claim only recites one additional element – using a processor to perform calculations and measurements. The processor circuit in the claim is recited at a high-level of generality such that it amounts no more than mere instructions to apply the exception using a generic computer component. Accordingly, this additional element does not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea. Additionally, the limitation of outputting a visual representation of the progression of the reperfusion therapy is a mere generic computer functionality that does not amount to significantly more that an abstract idea.
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the additional element of using a processor to perform both the measuring and determining steps amounts to no more than mere instructions to apply the exception using a generic computer component. Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept. The claim is not patent eligible.
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.
Claim(s) 1-10, 12-17 are rejected under 35 U.S.C. 103 as being unpatentable over Vaisnys et al. (US 2011/0092951) in view of Mohl (US 2011/0295302).
(1) regarding claim 1:
Vaisnys ‘951 discloses a system, comprising:
a processor circuit (paragraph [0051], where a processor is disclosed as able to performed the invention) configured to:
receive first external imaging data (paragraph [0043], monitoring maybe be non-invasive) of a first area of a heart of a patient associated with a first blood vessel with a blockage, wherein the first external imaging data includes blood flow through the first area (paragraph [0050]-[0053], where a first area of the patient with a blockage (ischemia is a form of blockage in the arteries) is analyzed for blood flow through the area);
determine a first measurement representative of the blood flow through the first area (paragraph [0051], the measure of oxygen saturation of hemoglobin in circulating blood is some blood vessel);
receive second external imaging data (paragraph [0043], monitoring maybe be non-invasive) of a different, second area of the heart associated with a different, second blood vessel of the heart lacking the blockage, wherein the second external imaging data includes blood flow through the second area (paragraph [0059]-[0062], where information is gathered from another area associated with healthy tissue);
determine a second measurement representative of the blood flow through the second area (paragraph [0055], and [0059]-[0062], where a measurement of the blood flow will be taken from the readings of the data of the healthy tissue as well);
determine a progression of a reperfusion therapy associated with the first area (paragraph [0055] and [0059], where feedback of the reperfusion therapy is obtained);
wherein, to determine the progression of the reperfusion therapy, the processor circuit is configured to determine a parameter representative of a relative blood flow between the first area and the second area based on the first measurement and the second measurement (paragraph [0053], and [0058]-[0059], where values concerning raw sensor signals to derive a sensor reading are defined, since these may be non-invasive sensor signals relevant to circulating blood is some blood vessels, it is evident that a ratio of blood flow is established between the reading of different areas of the patient tissues).
Vaisnys ‘951 discloses all the subject matter as described above except output a visual representation of the progression of the medical procedure to a display in communication with the processor circuit,
However, Mohl ‘302 teaches output a visual representation of the progression of the medical procedure to a display in communication with the processor circuit (paragraph [0025], where a display is used to offer visual references about the progress of a medical procedure to the surgeon),
Having a system of Mohl ‘302 reference and then given the well-established teaching of Vaisnys ‘951 reference, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Vaisnys ‘951 to include the limitations as taught by Mohl ‘302 because the user can readily monitor the patient's condition and the effects of intermittently occluding the coronary sinus 20 by viewing the graphical user interface while contemporaneously handling the coronary sinus occlusion catheter 120 other heart treatment instruments (e.g., angioplasty catheters, stent delivery instruments, or the like). It is believed that a rapid change in coronary flow can be detected by observing the pressure in the occluded coronary sinus, thus indicating any detrimental change of nutritive flow (paragraph [0025]).
(2) regarding claim 2:
Vaisnys ‘951 further discloses wherein the first external imaging data and the second external imaging data are obtained with contrast agent (paragraph [0043] and [0045], where the use of a contrast agent is used to obtain the reading of the vessel images).
(3) regarding claim 3:
Vaisnys ‘951 further discloses control, based on the parameter, an infusion pump in communication with the processor circuit to deliver the contrast agent to the first area and the second area (paragraphs [0043], [0045], where it is well known that several methods to pump (in inject) a contrast agent are used, e.g. syringe and pump).
(4) regarding claim 4:
Vaisnys ‘951 further discloses further comprising the infusion pump (paragraphs [0043], [0045], where it is well known that several methods to pump (in inject) a contrast agent are used, e.g. syringe and pump).
(5) regarding claim 5:
Vaisnys ‘951 further discloses the reperfusion therapy (paragraph [0055] and [0059], where feedback of the reperfusion therapy is obtained).
Vaisnys ‘951 discloses all the subject matter as described above except wherein the visual representation of the progression of the medical procedure comprises a visual representation of a derivative with respect to time of the parameter.
However, Mohl ‘302 teaches wherein the visual representation of the progression of the medical procedure comprises a visual representation of a derivative with respect to time of the parameter (paragraph [0025], where a display is used to offer visual references about the progress of a medical procedure to the surgeon, and where time is an essential parameter).
Having a system of Mohl ‘302 reference and then given the well-established teaching of Vaisnys ‘951 reference, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Vaisnys ‘951 to include the limitations as taught by Mohl ‘302 because the user can readily monitor the patient's condition and the effects of intermittently occluding the coronary sinus 20 by viewing the graphical user interface while contemporaneously handling the coronary sinus occlusion catheter 120 other heart treatment instruments (e.g., angioplasty catheters, stent delivery instruments, or the like). It is believed that a rapid change in coronary flow can be detected by observing the pressure in the occluded coronary sinus, thus indicating any detrimental change of nutritive flow (paragraph [0025]).
(6) regarding claim 6:
Vaisnys ‘951 further discloses wherein, to determine the parameter, the processor circuit is configured to: determine a ratio of the first measurement and the second measurement (paragraph [0053], and [0058]-[0059], where values concerning raw sensor signals to derive a sensor reading are defined, since these may be non-invasive sensor signals relevant to circulating blood is some blood vessels, it is evident that a ratio of blood flow is established between the reading of different areas of the patient tissues).
(7) regarding claim 7:
Vaisnys ‘951 further discloses wherein the first measurement comprises at least one of a wash-in rate, a wash-out rate, an intensity of the first external imaging data, a brightness of the first external imaging data, or a contrast velocity (paragraph [0043] and [0045], where the movement of the contrast agent is one of the main reasons why to use the contrast agent, with the movement of the contrast agent, the velocity can be easily obtained).
(8) regarding claim 8:
Vaisnys ‘951 further discloses receive selection of the first area, wherein the processor circuit is further configured to determine the first measurement responsive to the selection of the first area (paragraph [0050]-[0053], where a first area of the patient with a blockage (ischemia is a form of blockage in the arteries) is selected).
(9) regarding claim 9:
Vaisnys ‘951 further discloses identify the first area based on one or more features of the first external imaging data (paragraph [0050]-[0053], where a first area of the patient with a blockage (ischemia is a form of blockage in the arteries) is analyzed for blood flow through the area),
wherein the processor circuit is further configured to determine the first measurement responsive to the identification of the first area (paragraph [0051], the measure of oxygen saturation of hemoglobin in circulating blood is some blood vessel).
(10) regarding claim 10:
Vaisnys ‘951 further discloses wherein the one or more features of the first external imaging data comprise a stent, intravascular reperfusion therapy device, or the blockage (paragraph [0050]-[0053], where a first area of the patient with a blockage (ischemia is a form of blockage in the arteries) is analyzed for blood flow through the area).
(11) regarding claim 12:
Vaisnys ‘951 further discloses wherein the first area comprises a first portion of a myocardium of the heart and the second area comprises a different, second portion of the myocardium (paragraphs [0043], where different areas of the myocardium are used).
(12) regarding claim 13:
Vaisnys ‘951 further comprises wherein the first blood vessel comprises a first coronary artery and the second blood vessel comprises a second coronary artery (paragraphs [0043], [0045]).
(13) regarding claim 14:
Vaisnys ‘951 further discloses control delivery of the reperfusion therapy based on the parameter (paragraph [0053], and [0058]-[0059], where values concerning raw sensor signals to derive a sensor reading are defined, since these may be non-invasive sensor signals relevant to circulating blood is some blood vessels, it is evident that a ratio of blood flow is established between the reading of different areas of the patient tissues).
(14) regarding claim 15:
Vaisnys ‘951 further discloses instruct an intravascular reperfusion therapy device in communication with the processor circuit and positioned within a vessel of the patient to control the blood flow through the first area (paragraph [0058]).
(15) regarding claim 16:
Vaisnys ‘951 further discloses wherein the vessel comprises a coronary vein (paragraph [0045]).
(16) regarding claim 17:
Vaisnys ‘951 further discloses the intravascular reperfusion therapy device (paragraph [0058]).
Claim(s) 11, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Vaisnys et al. (US 2011/0092951) and Mohl (US 2011/0295302) as applied to claims above, and further in view of Nishioka et al. (US 2020/0113450).
(1) regarding claim 11:
Vaisnys ‘951 and Mohl ‘302 disclose all the subject matter as described above except wherein the first external imaging data comprises an x-ray image of the first area.
However, Nishioka ‘450 teaches wherein the first external imaging data comprises an x-ray image of the first area (paragraph [0029], where an x-ray image is used for imaging the blood flow).
Having a system of Nishioka ‘450 reference and then given the well-established teaching of Vaisnys ‘951 and Mohl ‘302, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Vaisnys ‘951 and Mohl ‘302 to include the limitations as taught by Nishioka ‘450 because the X-ray CT apparatus collects coronary angiography CT image data for calculating the blood flow volume of the coronary artery through fluid analysis, or myocardial contrast-enhanced CT image data for calculating the blood flow volume of the myocardium through perfusion analysis (paragraph [0029]).
(2) regarding claim 18:
Vaisnys ‘951 discloses a system, comprising:
a processor circuit (paragraph [0051], where a processor is disclosed as able to performed the invention) configured to:
receive first imaging data (paragraph [0043], monitoring maybe be non-invasive) of a first area of a heart of a patient, wherein the first imaging data comprises blood flow through the first area from a first blood vessel with a blockage, wherein the first area of the heart comprises at least one of a first portion of the myocardium (paragraphs [0043], where different areas of the myocardium are used) or the first blood vessel, wherein the first blood vessel comprises a first coronary artery (paragraph [0050]-[0053], where a first area of the patient with a blockage (ischemia is a form of blockage in the arteries) is analyzed for blood flow through the area);
determine, using the first imaging data, a first measurement representative of the blood flow through the first area based on a contrast agent (paragraph [0043] and [0045], where the use of a contrast agent is used to obtain the reading of the vessel images) within the first area (paragraph [0051], the measure of oxygen saturation of hemoglobin in circulating blood is some blood vessel);
receive second imaging data (paragraph [0043], monitoring maybe be non-invasive) of a different, second area of the heart, wherein the second imaging data comprises blood flow through the second area from a different, second blood vessel lacking the blockage, wherein the second area comprises at least one of a second portion of the myocardium or the second blood vessel, wherein the second blood vessel comprises a second coronary artery (paragraph [0059]-[0062], where information is gathered from another area associated with healthy tissue);
determine, using the second imaging data, a second measurement representative of the blood flow through the second area based on the contrast agent within the second area (paragraph [0055], and [0059]-[0062], where a measurement of the blood flow will be taken from the readings of the data of the healthy tissue as well);
determine a progression of a reperfusion therapy associated with the first area (paragraph [0055] and [0059], where feedback of the reperfusion therapy is obtained);
wherein, to determine the progression of the reperfusion therapy, the processor circuit is configured to determine a parameter representative of a relative blood flow between the first area and the second area based on the first measurement and the second measurement (paragraph [0053], and [0058]-[0059], where values concerning raw sensor signals to derive a sensor reading are defined, since these may be non-invasive sensor signals relevant to circulating blood is some blood vessels, it is evident that a ratio of blood flow is established between the reading of different areas of the patient tissues).
Vaisnys ‘951 discloses all the subject matter as described above except output a visual representation of the progression of the medical procedure to a display in communication with the processor circuit,
However, Mohl ‘302 teaches output a visual representation of the progression of the medical procedure to a display in communication with the processor circuit (paragraph [0025], where a display is used to offer visual references about the progress of a medical procedure to the surgeon),
Having a system of Mohl ‘302 reference and then given the well-established teaching of Vaisnys ‘951 reference, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Vaisnys ‘951 to include the limitations as taught by Mohl ‘302 because the user can readily monitor the patient's condition and the effects of intermittently occluding the coronary sinus 20 by viewing the graphical user interface while contemporaneously handling the coronary sinus occlusion catheter 120 other heart treatment instruments (e.g., angioplasty catheters, stent delivery instruments, or the like). It is believed that a rapid change in coronary flow can be detected by observing the pressure in the occluded coronary sinus, thus indicating any detrimental change of nutritive flow (paragraph [0025]).
Vaisnys ‘951 and Mohl ‘302 disclose all the subject matter as described above except wherein the imaging data is x-ray imaging data.
However, Nishioka ‘450 teaches wherein the imaging data is x-ray imaging data (paragraph [0029], where an x-ray image is used for imaging the blood flow).
Having a system of Nishioka ‘450 reference and then given the well-established teaching of Vaisnys ‘951 and Mohl ‘302, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Vaisnys ‘951 and Mohl ‘302 to include the limitations as taught by Nishioka ‘450 because the X-ray CT apparatus collects coronary angiography CT image data for calculating the blood flow volume of the coronary artery through fluid analysis, or myocardial contrast-enhanced CT image data for calculating the blood flow volume of the myocardium through perfusion analysis (paragraph [0029]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LENNIN R RODRIGUEZ whose telephone number is (571)270-1678. The examiner can normally be reached Monday-Thursday 9:00am-7:00pm.
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/LENNIN R RODRIGUEZGONZALEZ/ Primary Examiner, Art Unit 2683