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 Objections
Claims 9 and 18 are objected to because of the following informalities:
In claim 9, line 2, it appears ‘a’ should be ‘the’ and that the term ‘rate’ is missing after ‘flow’.
In claim 18, line 2, it appears ‘a’ should be ‘the’.
Appropriate correction is required.
Claim Rejections - 35 USC § 102
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 1, 5, 7-10, 14, and 16-18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Krivitski et al (US 6,623,436 -cited by applicant).
Re claims 1: Krivitski discloses an apparatus comprising:
(a) an introducer sheath having a proximal section, a distal section, and a passage extending from the proximal section to the distal section (col 11 line 66-col 12, line 2; see the introducer);
(b) an elongate catheter body having a distal section and a proximal end, the catheter body configured to cooperatively engage the introducer sheath to locate a first sensor on a first length of the catheter body beyond the distal port and a second sensor on a second length of the catheter body within the introducer sheath, wherein the second sensor is a thermal sensor (col 6, lines 60-65; col 7 lines 35-45; figures 1 and 2; see the catheter 10 and the injected indicator sensed by a first sensor on the distal end of the catheter; also see the plurality of sensors one of which is a second thermal sensor that is within the sheath), and
(c) a controller configured to receive signals from the second sensor and estimate or extrapolate a first temperature characteristic of a passing indicator corresponding to the received signals from the second sensor, wherein the controller calculates flow rate based on the estimation or extrapolation of the first characteristic (col 4, lines 28-31; see sensor 36 that measures temperature which is a thermal property; col 11, lines 9-23; see the controller that estimates characteristics of the indicator; col 5, lines 58-67; see that the flow rate is determined from the indicator characteristics).
Re claims 8, 17: The characteristic of the indicator is a temperature of the indicator, which corresponds to a predetermined thermal property of at least the second sensor (col 4, lines 28-31; see sensor 36 that measures temperature which is a thermal property).
Re claims 5, 14: The controller is configured to estimate or extrapolate a characteristic of the indicator corresponding to a downslope of a measured curve shape of a dilution curve sensed by the second sensor from a condition prior to passage of the indicator and maximum deviation from the condition prior to passage of the indicator and also corresponding to a lookup table (col 10, lines 19-23; see the dilution curve wherein the time period is correlated to the beginning of the downslope and wherein the values of the curve correspond to values as a lookup table).
Re claims 7, 16: The controller is configured to predict a temperature of the passing indicator corresponding to a predetermined time constant associated with the second sensor (col 5, lines 26-31; wherein the time that the indicator reaches the sensor is determined).
Re claims 9, 18: The controller is configured to receive signals from the second sensor and the first sensor and calculate a flow rate based on the estimation or extrapolation of the characteristic of an indicator passing the second sensor and the signal from first sensor (col 5, lines 58-67; see that the flow rate is determined from the indicator characteristics).
Re claim 10: Krivitski discloses a method comprising:
(a) locating a portion of a catheter assembly within a conduit having a flow to be measured, the catheter assembly having (i) an introducer sheath having a proximal section having an introduction port and a distal section having a distal port; (ii) a catheter having an exterior, wherein a first sensor is located on a distal section of the exterior of the catheter; and (ii) a passage fluidly connecting the introduction port and the distal port, wherein a second sensor is a thermal sensor and is located within the introducer sheath (col 11 line 66-col 12, line 2; col 6, lines 60-65; col 7 lines 35-45; figures 1 and 2; see the introducer which has an introduction port and distal port connected by a passage, the catheter 10 and the injected indicator sensed by a first sensor on the exterior distal end of the catheter; also see the plurality of sensors one of which is a second thermal sensor that is within the sheath);
(b) introducing an indicator into the passage through the introduction port;
(c) receiving signals from the second sensor (col 11, lines 9-23; see the controller that receives the sensor signals);
(d) extrapolating or estimating a characteristic of the passing indicator corresponding to the received signals from the second sensor, where the characteristic is a temperature of the indicator (col 11, lines 9-23; see the controller that estimates characteristics of the indicator; col 4, lines 28-31; see sensor 36 that measures temperature which is a thermal property); and
(e) calculating a flow rate based on the extrapolation or estimation of the first characteristic (col 5, lines 58-67; see that the flow rate is determined from the indicator characteristics).
Response to Arguments
Applicant's arguments filed 10/24/25 have been fully considered but they are not persuasive. Applicant argues that Krivitski does not disclose estimating or extrapolating the temperature of the indicator and then calculating the flow rate based on the extrapolation or estimation, but instead discloses determining blood flow rate by thermodilution measurements. Respectfully, the Examiner disagrees and finds that the dilution thermal sensors (i.e. the claimed second sensor) estimates a temperature of the injectate. Krivitski explicitly recites that the “thermal sensor monitors passage of the injectate” and that blood flow rate is determined based on the thermodilution measurements. While the sensors may be exposed to blood flow within the shunt, the indicator within the blood has a temperature that is measured. Given broadest reasonable interpretation, the measurement of the temperature is an estimate/extrapolation of the temperature of the indicator.
The prior 112 rejections are withdrawn due to amendments.
Conclusion
THIS ACTION IS MADE FINAL. 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 MICHAEL T ROZANSKI whose telephone number is (571)272-1648. The examiner can normally be reached Mon - Fri 8:00-4:00.
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/MICHAEL T ROZANSKI/Primary Examiner, Art Unit 3797