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 Amendment
Applicant has amended claim 29 which were previously objected to; Examiner accordingly withdraws the objections of claim 29.
Applicant has also added a practical application of the controller after using to controller to carry out a mental process (the practical application being the causing of a representation of the computed microvasculature resistance to be displayed on a display), overcoming the previous rejection of all pending claims on 35 U.S.C. 101.
Claims 1-14 have been cancelled. Applicant has added new claims 33-39 (40, see below); no new matter has been entered.
Examiner additionally notes that claim 26 remains withdrawn as it remains drawn to a nonelected species as called out in the previous Office Action.
Claim Objections
Claims 34 and both claims 35 are objected to because of the following informalities:
Regarding claim 34, there is a typographical error wherein the claim recites “below the reference pressure and he second arterial pressure is above” and should instead recite “”.
There is an error are currently 2 claims labeled as “Claim 35”. For the purposes of compact prosecution, Examiner has listed the second “Claim 35” as “Claim 40”. This is further reflected in the Index of Claims where the claim is reflected as claim 40.
Appropriate correction is required.
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.
Claim(s) 15-25 and 27-40 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gilbert (US 20170119260, henceforth Gilbert) in view of O’Connell et al. (US 20150133799, henceforth O’Connell) and Wahab (“Interpolation and Extrapolation”, by Muhammad Abdul Wahab on 05 February 2017, henceforth Wahab).
Regarding claim 15, Gilbert discloses an apparatus (assembly of fig. 6) for assessing a patient with a vascular stenosis and/or dysfunction (quantifying severity of coarctation of the aorta, [0002]), the apparatus comprising: a catheter (catheter of fig. 6A and [0085]) having a distal region (tip of catheter as in [0085]) sized and shaped to be advanced into an arterial vessel ([0045]), the catheter comprising a lumen (lumen that connects flow rate source 616 and the tip of the catheter for injection fluid as in [0085]-[0096]) for delivering a fluid into the arterial vessel ([0088]); a pressure sensor (first pressure sensor 610, fig. 6A) disposed at the distal region of the catheter (see fig. 6A and [0085]) to measure a pressure (sensor 610 measures pressure Ptip, [0085]); a reference pressure sensor (second pressure sensor 612, fig. 6A and [0085]) configured to measure a reference pressure (sensor 612 measures pressure Pb, [0085]) at a location proximal to the distal region (see [0085] and fig. 6A); and a controller (computing device or system of [0097]) operatively coupled to the reference pressure sensor and the pressure sensor (see [0085], the mentioned computing interface system is understood to be the computing device of [0097]), the controller configured to: cause the fluid to be delivered at a first volumetric flow rate through the lumen into the arterial vessel; measure a first arterial pressure in the arterial vessel while the fluid is delivered at the first volumetric flow rate; cause the fluid to be delivered at a second volumetric flow rate through the lumen into the arterial vessel; measure a second arterial pressure in the arterial vessel while the fluid is delivered at the second volumetric flow rate (patterns of flow rates as in [0002] includes at least a first and a second volumetric flow rate as at least two flow rates are required to constitute a pattern; see also [0061] and [0089] which discuss some of the optional patterns; Ptip is measured throughout the injection with varying flow rates as in [0092]-[0095], including a first Ptip at the first volumetric flow rate and a second Ptip at the second volumetric flow rate); perform analysis (the mathematical assessment disclosed in [0091]-[0094] is an analysis because it is a detailed examination of data to understand its nature which is the definition of an analysis per Merriam Webster) using the first and second volumetric flow rates and the first and second arterial pressures (use of the first Ptip at the first volumetric flow rate and the second Ptip at the second volumetric flow rate, see [0091]-[0094]) to determine an equipoise volumetric flow rate at which the corresponding pressure corresponds to the reference pressure (see [0091]-[0094]; this discloses that the controller is configured to determine how injected flow rates from the flow rate pattern cause the pressure at the tip of the catheter to vary in addition to the variations measured at the reference pressure sensor, which is understood to include the claimed equipoise volumetric flow rate since this would be determinable from the recorded values and the determined values present in the provided equations; see also claim 15, which discloses maintaining blood flow in the vasculature; see also the modification below with regards to Wahab); compute microvasculature resistance based on the equipoise volumetric flow rate and the reference pressure (see the given equations in [0093]; if resistance, or the inverse of conductance G, was desired, one of ordinary skill in the art would be able to manipulate the equations to see that resistance is equal to a set pressure measurement divided by a set flow rate; for the desired resistance value, the equipoise flow rate could be used; see also the modification below with regards to Wahab); and cause a representation of the computed microvasculature resistance to be displayed on a display (see [0007], the calculated values are shown on a display unit, such as unit 911 in [0121]).
While it appears that the apparatus of Gilbert is structurally and functionally capable of being used for assessing a patient with a vascular stenosis as claimed, there is no explicit disclosure in Gilbert as to how this could be achieved. O’Connell discloses an apparatus similar to that of Gilbert (see fig. 3) which is used for assessing a patient with a vascular stenosis ([0002]) including through the use of multiple pressure measurements (see Abstract and [0002]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have used the apparatus of Gilbert for the assessment of a patient with a vascular stenosis as in O’Connell for assessing severity of the stenosis and determining whether interventional treatment is needed or effective (see O’Connell [0002]). This assessment could be made by positioning the pressure sensor of the catheter of Gilbert in the same manner as the pressure sensor of the catheter of O’Connell (pressure sensor 124, fig. 1) where the pressure sensor is moved both distally and proximally to the stenosis to provide pressure measurements (see [0025], [0026]).
{Examiner notes that Gilbert claim 15 appears to be especially relevant when considering Gilbert in view of O’Connell, as O’Connell teaches that blood flow is reduced distal to a stenosis (see [0002], “the blockage limits blood flow within the vessel”), and Gilbert claim 15 includes maintaining blood flow; maintaining blood flow in the case of a stenosis blocking blood flow is understood to then mean calculating and delivering fluid at the equipoise volumetric flow rate as claimed.}
Gilbert as modified by O’Connell does not explicitly disclose that the analysis is regression analysis. Wahab teaches that regression analysis can be done on measured data sets to analyze mathematical relationships within and beyond that data set (Wahab, Section II, paragraph 3).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have configured the controller to have used the mathematical fitting equation of Gilbert (the equation disclosed in Gilbert [0093]) in a linear regression analysis to allow for linear extrapolation and interpolation of data points as desired such as in Wahab (Wahab, Section II, paragraphs 2 and 3). This would further allow one of ordinary skill in the art to configure the controller to calculate a flow rate or a pressure for any desired data point along the curve fitted by Gilbert and Wahab, such as the equipoise volumetric flow rate as claimed.
{Examiner notes that this curve fitting is a regression analysis as claimed where Merriam Webster defines a regression analysis to mean “the use of mathematical and statistical techniques to estimate one variable from another especially by the application of regression coefficients, regression curves, regression equations, or regression lines to empirical data”. In Gilbert as modified, empirical data is fitted to a linear equation to provide for further interpolation and extrapolation and estimation of one variable from another or from a desired data point, which makes this analysis a linear regression analysis.}
Regarding claim 16, Gilbert as modified discloses the apparatus wherein the controller is configured to compute microvasculature resistance by dividing the reference pressure by the equipoise volumetric flow rate (see the given equations in [0093]; if resistance, or the inverse of conductance G, was desired, one of ordinary skill in the art would be able to manipulate the equations to see that resistance is equal to a set pressure measurement divided by a set flow rate; for the desired resistance value, the equipoise flow rate could be used; this is further possible in light of the teachings of the use of interpolation and extrapolation from Wahab which teach using a fit curve to estimate one variable from another, see Wahab, Section III, part A.).
Regarding claim 17, Gilbert as modified discloses the apparatus wherein the fluid contains little or no available oxygen (the injected fluid appears to be drug or dissolved pharmacological agents as in [0008], it is understood that this would have little or no available oxygen since it the fluid pharmacological agents do not typically have much free oxygen).
Regarding claim 18, Gilbert as modified discloses the apparatus wherein the pressure sensor is disposed on the catheter (see fig. 6A and [0085], pressure sensor 610 is mounted onto the catheter).
Regarding claim 19, Gilbert as modified discloses the apparatus wherein the pressure sensor is disposed on the catheter (see fig. 6A and [0085], pressure sensor 610 is mounted onto the catheter).
Gilbert does not disclose the apparatus wherein the pressure sensor is disposed on a slidably guidewire coupled to and extendable beyond a distal end of the catheter. O’Connell teaches that mounting a pressure sensor on a catheter and mounting a pressure sensor on a guidewire coupled to a catheter are equivalent arrangements ([0024]). O’Connell further teaches this guidewire to be slidably coupled to said catheter (see at least Abstract, [0008]) and extendable beyond a distal end of the catheter (see fig. 3).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have mounted the pressure sensor on a guidewire coupled to the catheter of Gilbert instead of mounting the pressure sensor directly on the catheter as in Gilbert as O’Connell teaches these to be equivalent arrangements and such a substitution would have yielded the same, predictable result of a pressure sensor which can be located at the distal tip of the catheter and can be used to read pressure in the arterial vessel.
{Examiner notes that this modification does not require the sensor to be positioned such that it is extendable beyond a distal end of the catheter, as this is not required by the claim; rather, this is simply a mounting of the pressure sensor on the guidewire instead of on the catheter, with the pressure sensor still located in the same position along the catheter during measurement taking and operations of the device as disclosed in Gilbert. This would then not interfere with the functioning of Gilbert as the operational use of the apparatus is the same; it is simply a changing of arrangement as taught to be known as an obvious equivalent as in O’Connell.}
Regarding claim 20, Gilbert as modified discloses the apparatus wherein the catheter is balloonless (see fig. 6A, the catheter shown does not have a balloon and is thus balloonless).
Regarding claim 21, Gilbert as modified discloses the apparatus wherein regression analysis includes at least one of extrapolation or interpolation (see the modification made above in claim 15 and see Wahab, Section III, part A, interpolation and extrapolation are used following a function derived from multiple data points to find variable values for a desired data point).
Regarding claim 22, Gilbert as modified discloses the apparatus wherein the controller is further configured to cause the fluid to be delivered at the equipoise volumetric flow rate (see the first Examiner note in the rejection of claim 15 above and see Gilbert claim 15).
Regarding claim 23, Gilbert discloses the apparatus wherein the pressure sensor is configured to be advanced from a proximal side of a stenosis to a distal side of the stenosis (see fig. 1 of O’Connell and see [0002] of O’Connell, this advancement from a distal side of the stenosis to the proximal side of the stenosis is a part of measuring the pressures on either side of the stenosis to determine the severity of the stenosis; note also that while O’Connell shows this as being done with pressure sensors disposed on a guidewire, it notes that this can be completed with pressure sensors on a catheter as well as in [0024] which is the case for the use of the apparatus of Gilbert).
Regarding claim 24, Gilbert as modified does not disclose the apparatus further comprising a second pressure sensor, the pressure sensor and second pressure sensor configured to be disposed on opposite sides of a stenosis. O’Connell teaches the apparatus further comprising a second pressure sensor (pressure sensor 324B, fig. 3), a pressure sensor (pressure sensor 324A, which appears to be equivalent to the pressure sensor in Gilbert as it is used for the distal most measurement) and the second pressure sensor configured to be disposed on opposite sides of a stenosis (see fig. 3).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have used multiple pressure sensors at the site of the stenosis as in O’Connell instead of a single sensor at the distal measurement site as in Gilbert as O’Connell teaches that multiple pressure sensors disposed on either side of the stenosis is an equivalent embodiment to the use of a single sensor which is moved ([0025] and [0037]) and thus such a modification would have yielded the same, predictable result of pressure measurements being taken on both sides of the stenosis such as to be able to effectively measure pressures and assess the flow and pressure conditions of the arterial vessel. Such a modification could have been achieved either by adding the second sensor from O’Connell near the tip of the catheter of Gilbert in the catheter wall, or by arranging the sensors on a guidewire as shown in O’Connell (fig. 3) – note that O’Connell teaches either of these arrangements to be equivalent embodiments ([0027]).
Regarding claim 25, Gilbert as modified discloses the apparatus wherein the catheter is configured to deliver the fluid through an outlet port disposed at the distal region (see fig. 6A, the ending of the catheter is depicted as an outlet port which is the truncation of the internal lumen which allows for fluid to be injected therethrough; see [0085]).
Regarding claim 27, Gilbert as modified discloses the apparatus wherein the reference pressure sensor is disposed on the catheter at a location proximal to the distal region (see fig. 6A and [0085], second pressure sensor 612 is disposed on the catheter wall and is proximal to the catheter tip by a distance Δ as shown).
Regarding claim 28, Gilbert as modified discloses the apparatus wherein the reference pressure sensor is configured to be disposed in the patient's aorta (see [0001], sensor 612 is on the catheter which is capable of being inserted into the aorta, and thus it is considered that sensor 612 is capable of being, or configured to be, inserted into the aorta as claimed).
Regarding claim 29, Gilbert as modified does not disclose the apparatus further configured to measure a third arterial pressure and a fourth arterial pressure, the third arterial pressure measured at a point proximal of a stenosis in the arterial vessel and the fourth arterial pressure measured at a point distal to the stenosis. O’Connell teaches the apparatus further comprising the first pressure sensor (pressure sensor 324A, fig. 3) and the second pressure sensor (pressure sensor 324B, fig. 3), with the first pressure sensor and the second pressure sensor configured to be disposed on opposite sides of a stenosis (see fig. 3), and measuring a third arterial pressure (pressure measurement from sensor 324B, fig. 3 and [0037]) and a fourth arterial pressure (pressure measurement from sensor 324A, fig. 3 and [0037]), the third arterial pressure measured at a point proximal of a stenosis in the arterial vessel and the fourth arterial pressure measured at a point distal to the stenosis (see fig. 3 and [0037]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have added the second sensor of O’Connell to the apparatus of Gilbert and to have used these sensors to take the claimed multiple arterial pressure measurements at the same exact time as in O’Connell ([0037]) to provide the benefit of real-time calculations regarding the fractional flow reserve (FFR) and indicating in real time the stenosis severity (see O’Connell [0002] and [0037]). Such a modification could have been achieved either by adding the second sensor from O’Connell near the tip of the catheter of Gilbert in the catheter wall, or by arranging the sensors on a guidewire as shown in O’Connell (fig. 3) – note that O’Connell teaches either of these arrangements to be equivalent embodiments ([0027]).
Regarding claim 30, Gilbert as modified discloses the apparatus wherein the controller is further configured to characterize the stenosis based on the third arterial pressure and the fourth arterial pressure (see O’Connell [0002], “Calculation of the FFR value provides a lesion specific index of the functional severity of the stenosis”, and [0032], “Such continuous pressure calculations may provide additional information related to lesion morphology and significance of the stenosis to the operator.” – these denote a characterization of the stenosis based on the provided pressure measurements and calculations).
Regarding claim 31, Gilbert as modified discloses the apparatus wherein the controller is further configured to determine various conductance values (see Gilbert [0050] and [0093], resistance measurements are calculated as the inverse of the disclosed conductance).
Gilbert as modified does not explicitly disclose the determination of a stenosis resistance based on the third arterial pressure, the fourth arterial pressure, and the equipoise volumetric flow rate. However, in the modified device of Gilbert and O’Connell, it is the Examiner’s understanding that since the third arterial pressure, fourth arterial pressure, and equipoise volumetric flow rate are already measured or configured to be calculated, and since the mathematical relationships between these elements are disclosed especially in Gilbert ([0093]) and Wahab (see Sections II and III), one of ordinary skill in the art prior to the effective filing date could have replaced the appropriate variables to arrive at the stenosis resistance as claimed to provide additional information and metrics regarding the stenosis severity and its impact on blood flow.
Regarding claim 32, Gilbert as modified does not explicitly disclose the apparatus wherein the controller is further configured to determine a fractional flow reserve (FFR) based on the ratio of the fourth arterial pressure to the third arterial pressure. O’Connell teaches the determination of a FFR (see [0002] and [0037]) based on the ratio of the fourth arterial pressure to the third arterial pressure (see [0037]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have used the modified apparatus of Gilbert to have determined a FFR based on the ratio of the fourth arterial pressure to the third arterial pressure as in O’Connell as O’Connell teaches the use of FFR to be a useful indicator for determining the severity of a stenosis and determining whether or not treatment is needed or effective (O’Connell [0002]).
Regarding claim 33, Gilbert as modified discloses the apparatus wherein the regression analysis is linear regression analysis (see rejection of claim 15 above, the regression analysis is linear regression analysis because the equations given by Gilbert [0093] and further explained with regards to use of exactly two data points in Wahab, Section III, part A are linear equations used to fit a curve to data points to allow for estimation of various variables) and includes extrapolation (see Wahab, Section II, paragraph 3 regarding use of extrapolation) when the first arterial pressure and the second arterial pressure are below the reference pressure (when the data points used for linear regression analysis such as in Gilbert as modified both have values below the desired input value, extrapolation is used to estimate the desired variable, such as is disclosed in Wahab, Section II, paragraph 3).
Regarding claim 34, Gilbert as modified discloses the apparatus wherein the regression analysis is linear regression analysis (see rejection of claim 15 above, the regression analysis is linear regression analysis because the equations given by Gilbert [0093] and further explained with regards to use of exactly two data points in Wahab, Section III, part A are linear equations used to fit a curve to data points to allow for estimation of various variables) and includes interpolation (see Wahab, Section III, part A) when the first arterial pressure is below the reference pressure and the second arterial pressure is above the reference pressure (when the data points used for linear regression analysis such as in Gilbert as modified creates a range which the desired input value is within, interpolation is used to estimate the desired variable, such as is disclosed in Wahab, Section III, part A).
Regarding claim 35, Gilbert as modified discloses the apparatus wherein the regression analysis is linear regression analysis (see rejection of claim 15 above, the regression analysis is linear regression analysis because the equations given by Gilbert [0093] and further explained with regards to use of exactly two data points in Wahab, Section III, part A are linear equations used to fit a curve to data points to allow for estimation of various variables) and includes (1) extrapolation (see Wahab, Section II, paragraph 3 regarding use of extrapolation) when the first arterial pressure and the second arterial pressure are below the reference pressure (when the data points used for linear regression analysis such as in Gilbert as modified both have values below the desired input value, extrapolation is used to estimate the desired variable, such as is disclosed in Wahab, Section II, paragraph 3), and (2) interpolation (see Wahab, Section III, part A) when the first arterial pressure is below the reference pressure and the second arterial pressure is above the reference pressure (when the data points used for linear regression analysis such as in Gilbert as modified creates a range which the desired input value is within, interpolation is used to estimate the desired variable, such as is disclosed in Wahab, Section III, part A).
Regarding claim 36, Gilbert as modified discloses the apparatus wherein the controller is configured to determine the equipoise volumetric flow rate based on a plurality of infused flow rates including only the first flow rate and the second flow rate (in the modified device of Gilbert, the controller is configured to utilize interpolation and extrapolation based on only 2 collected data points as taught in Wahab; this means that the controller is functionally capable of determining the equipoise volumetric flow rate based on only the first flow rate and the second flow rate as claimed, and interpolation or extrapolation are then used to determine the equipoise volumetric flow rate).
Regarding claim 37, Gilbert as modified discloses the apparatus wherein the controller is configured to determine the equipoise volumetric flow rate based on a plurality of measured pressures including only the first arterial pressure, the second arterial pressure, and the reference pressure (in the modified device of Gilbert, the controller is configured to utilize interpolation and extrapolation based on only 2 collected data points as taught in Wahab; this means that the controller is functionally capable of determining the equipoise volumetric flow rate based on only the first measured pressure and the second measured pressure since these are variables which form part of the 2 data points, and interpolation or extrapolation are then used to determine the equipoise volumetric flow rate based on the measured reference pressure, where the measured reference pressure is used as the input variable which the output can be derived from, with the desired output variable being the equipoise volumetric flow rate).
Regarding claim 38, Gilbert as modified discloses the apparatus wherein the catheter includes an enlarged diameter section (outer shaft 618, fig. 6B, which is a part of the catheter of fig. 6 as disclosed in [0098]) configured to increase hydrodynamic resistance (since the diameter of outer shaft 618, as shown in fig. 6B, is larger than the diameter of insertion member 614, it would have a larger hydrodynamic resistance if fluid was meant to flow around it since it would take up more of the space of the vessel in which it is inserted due to its larger diameter).
Regarding claim 39, Gilbert as modified does not disclose the apparatus wherein the reference pressure sensor is remote from the catheter. O’Connell teaches that mounting a pressure sensor on a catheter and mounting a pressure sensor on a guidewire coupled to a catheter are equivalent arrangements ([0024]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have mounted the pressure sensor on a guidewire coupled to the catheter of Gilbert instead of mounting the pressure sensor directly on the catheter as in Gilbert as O’Connell teaches these to be equivalent arrangements and such a substitution would have yielded the same, predictable result of a pressure sensor which can be located along the length of the catheter and can be used to read pressure in the arterial vessel. Such a modified device would then include that the reference pressure sensor is remote from the catheter since it would be assembled integrally with a guidewire as opposed to formed into the wall of the catheter as in Gilbert.
Regarding claim 40, or second claim 35, Gilbert as modified discloses the apparatus wherein the controller is configured to determine the equipoise volumetric flow rate without causing the fluid to be delivered at the equipoise volumetric flow rate (in the modified device of Gilbert, the controller is functionally capable of determining the equipoise volumetric flow rate as claimed using interpolation and extrapolation as needed as described further in Wahab; this means that the controller is functionally capable of doing such a calculation without delivering the fluid at said flow rate; since this is a functional limitation and not a method step, this meets the claim limitations).
Response to Arguments
Applicant’s arguments with respect to claim(s) 15 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. The teaching of regression analysis, and more specifically linear regression analysis in dependent claims, come from new reference Wahab and thus render the previous arguments moot.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SAMUEL J MARRISON whose telephone number is (703)756-1927. The examiner can normally be reached M-F 7:00a-3:30p ET.
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/SAMUEL J MARRISON/Examiner, Art Unit 3783 /EMILY L SCHMIDT/Primary Examiner, Art Unit 3783