Office Action 1: Non-Final Rejection (2024-09-09)
Rejection types: 103 - Obviousness, Double Patenting

CLAIMS:
CLAIMS:

1\. A system for determining blood flow within a blood vessel, the system comprising:
a fluid infusion device configured to continuously infuse a fluid into the blood vessel at an infusion rate that generates a mixture of the fluid and blood within the blood vessel;
at least one sensor configured to simultaneously measure a plurality of temperature
values at a plurality of locations along a length of the blood vessel to determine a temperature profile along the length of the blood vessel;
a temperature values determining processor configured to:
determine, based on the plurality of temperature values, a first temperature value at a first location along the length of the blood vessel, the first temperature
value indicating temperature of the fluid, and
determine, based on the plurality of temperature values, a second temperature value at a second location along the length of the blood vessel, the second temperature value indicating temperature of the mixture; and
a blood flow determining processor configured to:
determine the blood flow within the blood vessel based on the first temperature value, the second temperature values, and the infusion rate.

2\. The system as defined in claim 1, wherein the at least one sensor comprises an optical fiber configured to measure the plurality of temperature values at the plurality of locations along the length of the blood vessel.

3\. The system as defined in claim 2, wherein:
the fluid infusion device comprises a tube; and
the optical fiber is integrated with a guiding element configured to guide the tube into
the blood vessel.

4\. The system as defined in claim 3, wherein the optical fiber is arranged along a longitudinal axis of the guiding element or wound around the guiding element.

5\. The system as defined in claim 2, wherein:
the optical fiber is an optical shape sensing fiber; and
the system further comprises a locations determination processor connectable to the optical fiber and configured to:
determine the first location at which the temperature values determining processor determines the first temperature value, and
determine the second location at which the temperature values determining processor determines the second temperature value.

6\. The system as defined in claim 2, further comprising:
a property sensor configured to generation a sensing signal based on a property to be sensed within the blood vessel; and
a power generator configured to power the property sensor by light received from the optical fiber, wherein the optical fiber is configured to transmit the sensing signal outside of
the blood vessel.

7\. The system as defined in claim 6, wherein:
the property sensor is configured to generate a pressure sensing signal indicating pressure in the blood; and
the system further comprises a resistance determination processor configured to determine resistance based on the pressure indicated by the pressure sensing signal and the determined blood flow.

8\. The system as defined in claim 1, wherein the temperature values determining processor is further configured to:
determine the first location and the second location based on the plurality of temperature values measured at the plurality of locations along the length of the blood vessel.

9\. The system as defined in claim 1, wherein:
the fluid infusion device comprises a tube with a tube opening, wherein the tube is configured to guide the fluid into the blood vessel through the tube opening; and
the temperature values determining processor is further configured to:
determine the first temperature value at the first location which is within the tube or at a location of the tube opening, and determine the second temperature value at the second location which is distal from the tube opening location.

10\. The system as defined in claim 1, further comprising:
an assessment processor configured to determine a quality value indicating a degree of mixing of the fluid and the blood based on the plurality of temperature values measured at the plurality of locations along the length of the blood vessel.

11\. The system as defined in claim 10, wherein the assessment processor is configured to determine that the quality value indicates a sufficient degree of mixing, if a spatial variation of the plurality of temperature values is smaller than a predefined spatial threshold.

12\. The system as defined in claim 1, further comprising:
an assessment processor configured to determine a quality value indicating quality of
determining the blood flow based on a variation of the blood flow determined over time.

13\. A method for determining blood flow within a blood vessel, the method comprising:
infusing a fluid into the blood vessel at an infusion rate that generates a mixture of the fluid and blood within the blood vessel; and
while the fluid is continuously infused into the blood vessel at the infusion rate:
simultaneously measuring a plurality of temperature values at a plurality of locations along a length of the blood vessel to determine a temperature profile along the length of the blood vessel, determining, based on the plurality of temperature values, a first temperature value at
a first location along the length of the blood vessel, the first temperature value indicating temperature of the fluid, determining, based on the plurality of temperature values, a second temperature value at a second location along the length of the blood vessel, the second temperature value indicating temperature of the mixture of the fluid and the blood, and
determining the blood flow based on the first temperature value, the second temperature value, and the infusion rate.

14\. The method as defined in claim 13, further comprising:
determining the first location and the second location based on the plurality of temperature values measured at the plurality of locations along the length of the blood vessel.

15\. The method as defined in claim 13, further comprising:
determining a quality value indicating a degree of mixing of the fluid and the blood based on the plurality of temperature values measured at the plurality of locations along the length of the blood vessel.

16\. The method as defined in claim 13, further comprising:
determining a quality value indicating quality of determining the blood flow based on a variation of the blood flow determined over time.

17\. A non-transitory computer-readable storage medium having stored a computer program comprising instructions for determining blood flow within a blood vessel, the instructions, when executed by a processor, cause the processor to:
while a fluid is continuously infused into the blood vessel at an infusion rate:
receive, from at least one sensor, a plurality of temperature values simultaneously measured at a plurality of locations along a length of the blood vessel
to determine a temperature profile along the length of the blood vessel, determine, based on the plurality of temperature values, a first temperature value at a first location along the length of the blood vessel, the first temperature value indicating temperature of the fluid, determine, based on the plurality of temperature values, a second temperature value at a second location along the length of the blood vessel, the second temperature value indicating temperature of a mixture of the fluid and blood within the blood vessel, and
determine the blood flow based on the first temperature value, the second temperature value, and the infusion rate.

18\. The non-transitory computer-readable storage medium as defined in claim 17, wherein the instructions, when executed by the processor, further cause the processor to:
determine the first location and the second location based on the plurality of temperature values measured at the plurality of locations along the length of the blood vessel.

19\. The non-transitory computer-readable storage medium as defined in claim 17, wherein the instructions, when executed by the processor, further cause the processor to:
determine a quality value indicating a degree of mixing of the fluid and the blood
based on the plurality of temperature values measured at the plurality of locations along the length of the blood vessel.

20\. The non-transitory computer-readable storage medium as defined in claim 17, wherein the instructions, when executed by the processor, further cause the processor to:
determine a quality value indicating quality of determining the blood flow based on a variation of the blood flow determined over time. 5 10 15 20 25 30

OFFICE ACTION:
DETAILED ACTION
Summary
Claims 1-20 are pending in the application. Claims 1-9, 12-14, 16-18, and 20 are rejected under 35 USC 103. Claims 1-9, 12-14, 16-18, and 20 are rejected under non-statutory double patenting.
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 § 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary.  Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-5, 8-9, 13-14, and 17-18 are rejected under 35 U.S.C. 103 as being unpatentable over Pijls (U.S PGPub 2007/0078352 A1) in view of ‘T Hooft et al. (U.S PGPub 2014/0194757 A1).
Regarding Claim 1, Pijls teaches a system for determining blood flow within a blood vessel (Abstract), the system comprising:
a fluid infusion device (Fig. 3, infusion catheter) configured to continuously infuse a fluid into the blood vessel at an infusion rate that generates a mixture of the fluid and blood within the blood vessel [0009];
at least one sensor (Fig. 3, sensor) configured to measure a plurality of temperature values at a plurality of locations along a length of the blood vessel [0032]-[0033];
a temperature values determining processor [0027] configured to:
determine, based on the plurality of temperature values, a first temperature value at a first location along the length of the blood vessel, the first temperature value indicating temperature of the fluid [0033], and
determine, based on the plurality of temperature values, a second temperature value at a second location along the length of the blood vessel, the second temperature value indicating temperature of the mixture [0032]; and
a blood flow determining processor [0027] configured to:
determine the blood flow within the blood vessel based on the first temperature value, the second temperature values, and the infusion rate [0015]-[0016].
Pijls fails to explicitly teach that the at least one sensor is configured to simultaneously measure a plurality of temperature values to determine a temperature profile along the length of the blood vessel.
‘T Hooft teaches a system for measuring blood flow in the body (Abstract). This system contains a sensor which is configured to simultaneously measure a plurality of temperature values [0010]-[0011] to determine a temperatures profile along the length of the blood vessel [0050]+[0057].
It would have been obvious to one of ordinary skill in the art to modify the system of Pijls to use the temperature sensor to simultaneously measure the temperature values, as taught by ‘T Hooft, because this provides an easier method to rapidly perform readings along an artery, as recognized by ‘T Hooft [0006].
Regarding Claim 2, the combination of references teaches the invention substantially as claimed. Pijls fails to explicitly teach wherein the at least one sensor comprises an optical fiber configured to measure the plurality of temperature values at the plurality of locations along the length of the blood vessel.
‘T Hooft further teaches wherein the at least one sensor comprises an optical fiber configured to measure the plurality of temperature values at the plurality of locations along the length of the blood vessel [0008].
It would have been obvious to one of ordinary skill in the art to modify the system of Pijls to so the at least one sensor is an optical fiber, as taught by ‘T Hooft, because this provides an easier method to rapidly perform readings along an artery, as recognized by ‘T Hooft [0006].
Regarding Claim 3, the combination of references teaches the invention substantially as claimed. Pijls further teaches the fluid infusion device comprises a tube (Fig. 3, infusion catheter) [0028]; and the sensor is integrated with a guiding element configured to guide the tube into the blood vessel [0028].
While Pijls teaches the sensor is integrated on a guiding element, Pijls fails to explicitly teach the sensor is an optical fiber.
‘T Hooft further teaches wherein the at least one sensor comprises an optical fiber configured to measure the plurality of temperature values at the plurality of locations along the length of the blood vessel [0008]. This optical fiber can be integrated on a guidewire [0018].
It would have been obvious to one of ordinary skill in the art to modify the system of Pijls to so the at least one sensor is an optical fiber, as taught by ‘T Hooft, because this provides an easier method to rapidly perform readings along an artery, as recognized by ‘T Hooft [0006].
Regarding Claim 4, the combination of references teaches the invention substantially as claimed. Pijls fails to explicitly teach wherein the optical fiber is arranged along a longitudinal axis of the guiding element or wound around the guiding element.
‘T Hooft further teaches the optical fiber is arranged along a longitudinal axis of the guiding element (Fig. 3, the FB (optical fiber) is extending longitudinally along the device) (Fig. 4, the FB is in the center of the guidewire) [0052]-[0053].
It would have been obvious to one of ordinary skill in the art to modify the system of Pijls to so the optical fiber extends along a longitudinal axis, as taught by ‘T Hooft, because this provides an easier method to rapidly perform readings along an artery, as recognized by ‘T Hooft [0006].
Regarding Claim 5, the combination of references teaches the invention substantially as claimed. Pijls fails to explicitly teach wherein: the optical fiber is an optical shape sensing fiber; and the system further comprises a locations determination processor connectable to the optical fiber and configured to: determine the first location at which the temperature values determining processor determines the first temperature value, and determine the second location at which the temperature values determining processor determines the second temperature value.
‘T Hooft further teaches the optical fiber is an optical shape sensing fiber [0063]; and the system further comprises a locations determination processor connectable to the optical fiber [0010]+[0046] and configured to: determine the first location at which the temperature values determining processor determines the first temperature value [0030]-[0031]+[0044], and determine the second location at which the temperature values determining processor determines the second temperature value [0030]-[0031]+[0044].
It would have been obvious to one of ordinary skill in the art to modify the system of Pijls to so the optical fiber is a shape sensing fiber and determining the temperature locations, as taught by ‘T Hooft, because this provides an easier method to rapidly perform readings along an artery, as recognized by ‘T Hooft [0006].
Regarding Claim 8, the combination of references teaches the invention substantially as claimed. Pijls fails to explicitly teach wherein the temperature values determining processor is further configured to: determine the first location and the second location based on the plurality of temperature values measured at the plurality of locations along the length of the blood vessel.
‘T Hooft further teaches wherein the temperature values determining processor  [0063] is further configured to: determine the first location and the second location based on the plurality of temperature values measured at the plurality of locations along the length of the blood vessel [0030]-[0031]+[0044].
It would have been obvious to one of ordinary skill in the art to modify the system of Pijls to so determines the locations based on the temperatures, as taught by ‘T Hooft, because this provides an easier method to rapidly perform readings along an artery, as recognized by ‘T Hooft [0006].
Regarding Claim 9, the combination of references teaches the invention substantially as claimed. Pijls further teaches wherein: the fluid infusion device comprises a tube (Fig. 3, infusion catheter) with a tube opening [0029], wherein the tube is configured to guide the fluid into the blood vessel through the tube opening [0029]; and the temperature values determining processor [0027]  is further configured to: determine the first temperature value at the first location which is within the tube or at a location of the tube opening [0033], and determine the second temperature value at the second location which is distal from the tube opening location [0029]+[0032].
Regarding Claim 13, Pijls teaches a method for determining blood flow within a blood vessel (Abstract), the method comprising:
infusing a fluid into the blood vessel at an infusion rate that generates a mixture of the fluid and blood within the blood vessel; and [0009]
while the fluid is continuously infused into the blood vessel at the infusion rate [0009]:
measuring a plurality of temperature values at a plurality of locations along a length of the blood vessel [0032]-[0033],
determining, based on the plurality of temperature values, a first temperature value at a first location along the length of the blood vessel, the first temperature value indicating temperature of the fluid [0033],
determining, based on the plurality of temperature values, a second temperature value at a second location along the length of the blood vessel, the second temperature value indicating temperature of the mixture of the fluid and the blood [0032], and
determining the blood flow based on the first temperature value, the second temperature value, and the infusion rate [0015]-[0016].
Pijls fails to explicitly teach simultaneously measuring a plurality of temperature values to determine a temperature profile along the length of the blood vessel.
‘T Hooft teaches a system for measuring blood flow in the body (Abstract). This system contains a sensor which is configured to simultaneously measure a plurality of temperature values [0010]-[0011] to determine a temperatures profile along the length of the blood vessel [0050]+[0057].
It would have been obvious to one of ordinary skill in the art to modify the system of Pijls to use the temperature sensor to simultaneously measure the temperature values, as taught by ‘T Hooft, because this provides an easier method to rapidly perform readings along an artery, as recognized by ‘T Hooft [0006].
Regarding Claim 14, the combination of references teaches the invention substantially as claimed. Pijls fails to explicitly teach determining the first location and the second location based on the plurality of temperature values measured at the plurality of locations along the length of the blood vessel.
‘T Hooft further teaches wherein the temperature values determining processor  [0063] is further configured to: determine the first location and the second location based on the plurality of temperature values measured at the plurality of locations along the length of the blood vessel [0030]-[0031]+[0044].
It would have been obvious to one of ordinary skill in the art to modify the system of Pijls to so determines the locations based on the temperatures, as taught by ‘T Hooft, because this provides an easier method to rapidly perform readings along an artery, as recognized by ‘T Hooft [0006].
Regarding Claim 17, Pijls teaches a non-transitory computer-readable storage medium having stored a computer program comprising instructions for determining blood flow within a blood vessel, the instructions, when executed by a processor [0027], cause the processor to:
while a fluid is continuously infused into the blood vessel at an infusion rate [0009]:
receive, from at least one sensor (Fig. 3, sensor), a plurality of temperature values measured at a plurality of locations along a length of the blood vessel [0032]-[0033],
determine, based on the plurality of temperature values, a first temperature value at a first location along the length of the blood vessel, the first temperature value indicating temperature of the fluid [0033],
determine, based on the plurality of temperature values, a second temperature value at a second location along the length of the blood vessel, the second temperature value indicating temperature of a mixture of the fluid and blood within the blood vessel [0032], and
determine the blood flow based on the first temperature value, the second temperature value, and the infusion rate [0015]-[0016].
Pijls fails to explicitly teach that the at least one sensor is configured to simultaneously measure a plurality of temperature values to determine a temperature profile along the length of the blood vessel.
‘T Hooft teaches a system for measuring blood flow in the body (Abstract). This system contains a sensor which is configured to simultaneously measure a plurality of temperature values [0010]-[0011] to determine a temperatures profile along the length of the blood vessel [0050]+[0057].
It would have been obvious to one of ordinary skill in the art to modify the system of Pijls to use the temperature sensor to simultaneously measure the temperature values, as taught by ‘T Hooft, because this provides an easier method to rapidly perform readings along an artery, as recognized by ‘T Hooft [0006].
Regarding Claim 18, the combination of references teaches the invention substantially as claimed. Pijls fails to explicitly teach wherein the instructions, when executed by the processor, further cause the processor to: determine the first location and the second location based on the plurality of temperature values measured at the plurality of locations along the length of the blood vessel.
‘T Hooft further teaches wherein the temperature values determining processor  [0063] is further configured to: determine the first location and the second location based on the plurality of temperature values measured at the plurality of locations along the length of the blood vessel [0030]-[0031]+[0044].
It would have been obvious to one of ordinary skill in the art to modify the system of Pijls to so determines the locations based on the temperatures, as taught by ‘T Hooft, because this provides an easier method to rapidly perform readings along an artery, as recognized by ‘T Hooft [0006].
Claims 6-7 are rejected under 35 U.S.C. 103 as being unpatentable over Pijls in view of ‘T Hooft as applied to claim 2 above, and further in view of Van Der Mark et al. (U.S PGPub 2015/0335231 A1).
Regarding Claim 6, the combination of references teaches the invention substantially as claimed. Pijls further teaches a property sensor configured to generation a sensing signal based on a property to be sensed within the blood vessel [0038] ([0027] shows the pressure sensor outputs a sensing signal).
Pijls fails to explicitly teach a power generator configured to power the property sensor by light received from the optical fiber, wherein the optical fiber is configured to transmit the sensing signal outside of the blood vessel.
Van Der Meek teaches an optical probe system (Abstract). This system has a power generator that powers property sensors [0020]-[0021] by light received from an optical fiber [0025]. The optical fiber system can be used with a pressure sensor [0054], and can transmit the obtained signal to a control unit which is outside of the blood vessel (Fig. 1, 21) [0090]-[0091].
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the combined system to have a power generator, as taught by Van Der Meek, because this provides a faster, more accurate probe for obtaining data, as recognized by Van Der Meek [0014].
Regarding Claim 7, the combination of references teaches the invention substantially as claimed. Pijls further teaches the property sensor is configured to generate a pressure sensing signal indicating pressure in the blood [0038]; and the system further comprises a resistance determination processor [0027] configured to determine resistance based on the pressure indicated by the pressure sensing signal and the determined blood flow [0025]+[0039].
Claims 12, 16 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Pijls in view of ‘T Hooft as applied to claim 1 above, and further in view of Yang et al. (Yang, Xiao-Xing, Lester A. Critchley, and Gavin M. Joynt. Determination of the precision error of the pulmonary artery thermodilution catheter using an in vitro continuous flow test rig. Anesthesia & Analgesia 112.1 (2011): 70-77.).
Regarding Claim 12, the combination of references teaches the invention substantially as claimed. The combination fails to explicitly teach an assessment processor configured to determine a quality value indicating quality of determining the blood flow based on a variation of the blood flow determined over time.
Yang teaches a system for determining blood flow (Abstract). This system uses a processor (Fig. 1, flow meter) to determine a quality value (coefficient of variability) which indicates a quality (the reproducibility) of the blood flow based on variation of the blood flow over time (Pg. 72, The Random Component).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the combined system to determine a quality value, as taught by Yang, because knowing the variability of the measurement helps to quantify the precision error of the measurement, thereby improving the clinician’s ability to interpret the data, as recognized by Yang (Abstract).
Regarding Claim 16, the combination of references teaches the invention substantially as claimed. The combination fails to explicitly teach determining a quality value indicating quality of determining the blood flow based on a variation of the blood flow determined over time.
Yang teaches a system for determining blood flow (Abstract). This system uses a processor (Fig. 1, flow meter) to determine a quality value (coefficient of variability) which indicates a quality (the reproducibility) of the blood flow based on variation of the blood flow over time (Pg. 72, The Random Component).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the combined system to determine a quality value, as taught by Yang, because knowing the variability of the measurement helps to quantify the precision error of the measurement, thereby improving the clinician’s ability to interpret the data, as recognized by Yang (Abstract).
Regarding Claim 20, the combination of references teaches the invention substantially as claimed. The combination fails to explicitly teach wherein the instructions, when executed by the processor, further cause the processor to: determine a quality value indicating quality of determining the blood flow based on a variation of the blood flow determined over time.
Yang teaches a system for determining blood flow (Abstract). This system uses a processor (Fig. 1, flow meter) to determine a quality value (coefficient of variability) which indicates a quality (the reproducibility) of the blood flow based on variation of the blood flow over time (Pg. 72, The Random Component).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the combined system to determine a quality value, as taught by Yang, because knowing the variability of the measurement helps to quantify the precision error of the measurement, thereby improving the clinician’s ability to interpret the data, as recognized by Yang (Abstract).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA  as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-5, 8-9, 13-14, and 17-18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 6, 9, and 10 of U.S. Patent No. 11,564,584in view of Pijls and ‘T Hooft.
Regarding Claim 1, the Patent teaches a system for determining blood flow within a blood vessel, (Claim 1, Col 14, line 59) the system comprising:
a fluid infusion device (Claim 6) configured to infuse a fluid into the blood vessel at an infusion rate that generates a mixture of the fluid and blood within the blood vessel (Claim 1, Col 14, lines 60-63);
at least one sensor (Claim 1, Col 14-15, lines 64-1) configured to measure a plurality of temperature values at a plurality of locations along a length of the blood vessel (Claim 1, Col 14-15, lines 64-1);
a temperature values determining processor configured to: determine, based on the plurality of temperature values, a first temperature value at a first location along the length of the blood vessel (Claim 1, Col 14, lines 63-66),
determine, based on the plurality of temperature values, a second temperature value at a second location along the length of the blood vessel (Claim 1, Col 14-15, lines 67-1),
a blood flow determining processor configured to: determine the blood flow within the blood vessel based on the first temperature value, the second temperature values, and the infusion rate (Claim 1, Col 15, lines 8-17).
The Patent fails to explicitly teach continuously infusing a fluid, the first temperature value indicating temperature of the fluid, and the second temperature value indicating temperature of the mixture.
Pijls teaches continuously infusing a fluid [0009], the first temperature value indicating temperature of the fluid [0033], and the second temperature value indicating temperature of the mixture [0032].
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the Patent to infuse the fluid and measure the temperatures, as taught by Pijls, because this enhances the usefulness of blood flow measurements, as recognized by Pijls [0006].
The combination fails to explicitly teach that the at least one sensor is configured to simultaneously measure a plurality of temperature values to determine a temperature profile along the length of the blood vessel.
‘T Hooft teaches a system for measuring blood flow in the body (Abstract). This system contains a sensor which is configured to simultaneously measure a plurality of temperature values [0010]-[0011] to determine a temperatures profile along the length of the blood vessel [0050]+[0057].
It would have been obvious to one of ordinary skill in the art to modify the combined system to use the temperature sensor to simultaneously measure the temperature values, as taught by ‘T Hooft, because this provides an easier method to rapidly perform readings along an artery, as recognized by ‘T Hooft [0006].
Regarding Claim 2, the combination of references teaches the invention substantially as claimed. The Patent fails to explicitly teach wherein the at least one sensor comprises an optical fiber configured to measure the plurality of temperature values at the plurality of locations along the length of the blood vessel.
‘T Hooft further teaches wherein the at least one sensor comprises an optical fiber configured to measure the plurality of temperature values at the plurality of locations along the length of the blood vessel [0008].
It would have been obvious to one of ordinary skill in the art to modify the combined system to so the at least one sensor is an optical fiber, as taught by ‘T Hooft, because this provides an easier method to rapidly perform readings along an artery, as recognized by ‘T Hooft [0006].
Regarding Claim 3, the combination of references teaches the invention substantially as claimed. The Patent further teaches the fluid infusion device comprises a tube (Claim 4)
The Patent fails to explicitly teach the sensor is integrated with a guiding element configured to guide the tube into the blood vessel [0028].
Pijls further teaches the sensor is integrated with a guiding element configured to guide the tube into the blood vessel [0028].
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the Patent to integrate the sensor, as taught by Pijls, because this enhances the usefulness of blood flow measurements, as recognized by Pijls [0006].
While Pijls teaches the sensor is integrated on a guiding element, Pijls fails to explicitly teach the sensor is an optical fiber.
‘T Hooft further teaches wherein the at least one sensor comprises an optical fiber configured to measure the plurality of temperature values at the plurality of locations along the length of the blood vessel [0008]. This optical fiber can be integrated on a guidewire [0018].
It would have been obvious to one of ordinary skill in the art to modify the combined system to so the at least one sensor is an optical fiber, as taught by ‘T Hooft, because this provides an easier method to rapidly perform readings along an artery, as recognized by ‘T Hooft [0006].
Regarding Claim 4, the combination of references teaches the invention substantially as claimed. The Patent fails to explicitly teach wherein the optical fiber is arranged along a longitudinal axis of the guiding element or wound around the guiding element.
‘T Hooft further teaches the optical fiber is arranged along a longitudinal axis of the guiding element (Fig. 3, the FB (optical fiber) is extending longitudinally along the device) (Fig. 4, the FB is in the center of the guidewire) [0052]-[0053].
It would have been obvious to one of ordinary skill in the art to modify the combined system to so the optical fiber extends along a longitudinal axis, as taught by ‘T Hooft, because this provides an easier method to rapidly perform readings along an artery, as recognized by ‘T Hooft [0006].
Regarding Claim 5, the combination of references teaches the invention substantially as claimed. The Patent fails to explicitly teach wherein: the optical fiber is an optical shape sensing fiber; and the system further comprises a locations determination processor connectable to the optical fiber and configured to: determine the first location at which the temperature values determining processor determines the first temperature value, and determine the second location at which the temperature values determining processor determines the second temperature value.
‘T Hooft further teaches the optical fiber is an optical shape sensing fiber [0063]; and the system further comprises a locations determination processor connectable to the optical fiber [0010]+[0046] and configured to: determine the first location at which the temperature values determining processor determines the first temperature value [0030]-[0031]+[0044], and determine the second location at which the temperature values determining processor determines the second temperature value [0030]-[0031]+[0044].
It would have been obvious to one of ordinary skill in the art to modify the combined system to so the optical fiber is a shape sensing fiber and determining the temperature locations, as taught by ‘T Hooft, because this provides an easier method to rapidly perform readings along an artery, as recognized by ‘T Hooft [0006].
Regarding Claim 8, the combination of references teaches the invention substantially as claimed. The Patent fails to explicitly teach wherein the temperature values determining processor is further configured to: determine the first location and the second location based on the plurality of temperature values measured at the plurality of locations along the length of the blood vessel.
‘T Hooft further teaches wherein the temperature values determining processor  [0063] is further configured to: determine the first location and the second location based on the plurality of temperature values measured at the plurality of locations along the length of the blood vessel [0030]-[0031]+[0044].
It would have been obvious to one of ordinary skill in the art to modify the combined system to so determines the locations based on the temperatures, as taught by ‘T Hooft, because this provides an easier method to rapidly perform readings along an artery, as recognized by ‘T Hooft [0006].
Regarding Claim 9, the combination of references teaches the invention substantially as claimed. The Patent further teaches wherein: the fluid infusion device comprises a tube with a tube opening (Claim 4), wherein the tube is configured to guide the fluid into the blood vessel through the tube opening (Claim 4).
The Patent fails to explicitly teach the temperature values determining processor is further configured to: determine the first temperature value at the first location which is within the tube or at a location of the tube opening [0033], and determine the second temperature value at the second location which is distal from the tube opening location.
Pijls further teaches the temperature values determining processor [0027] is further configured to: determine the first temperature value at the first location which is within the tube or at a location of the tube opening [0033], and determine the second temperature value at the second location which is distal from the tube opening location [0029]+[0032].
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the Patent to determine the temperatures, as taught by Pijls, because this enhances the usefulness of blood flow measurements, as recognized by Pijls [0006].
Regarding Claim 13, the Patent teaches a method for determining blood flow within a blood vessel (Claim 9, Col 16, line 9), the method comprising:
an infusion rate that generates a mixture of the fluid and blood within the blood vessel (Claim 9, Col 16, lines 14-15) ; and
while the fluid is continuously infused into the blood vessel at the infusion rate:
measuring a plurality of temperature values at a plurality of locations along a length of the blood vessel (Claim 9, Col 16, lines 11-23),
determining, based on the plurality of temperature values, a first temperature value at a first location along the length of the blood vessel (Claim 9, Col 16, lines 10-15), the first temperature value indicating temperature of the fluid,
determining, based on the plurality of temperature values, a second temperature value at a second location along the length of the blood vessel (Claim 9, Col 16, lines 16-23), the second temperature value indicating temperature of the mixture of the fluid and the blood, and
determining the blood flow based on the first temperature value, the second temperature value, and the infusion rate (Claim 9, Col 16, lines 24-32).
The Patent fails to explicitly teach continuously infusing a fluid, the first temperature value indicating temperature of the fluid, and the second temperature value indicating temperature of the mixture.
Pijls teaches continuously infusing a fluid [0009], the first temperature value indicating temperature of the fluid [0033], and the second temperature value indicating temperature of the mixture [0032].
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the Patent to infuse the fluid and measure the temperatures, as taught by Pijls, because this enhances the usefulness of blood flow measurements, as recognized by Pijls [0006].
The combination fails to explicitly teach that the at least one sensor is configured to simultaneously measure a plurality of temperature values to determine a temperature profile along the length of the blood vessel.
‘T Hooft teaches a system for measuring blood flow in the body (Abstract). This system contains a sensor which is configured to simultaneously measure a plurality of temperature values [0010]-[0011] to determine a temperatures profile along the length of the blood vessel [0050]+[0057].
It would have been obvious to one of ordinary skill in the art to modify the combined system to use the temperature sensor to simultaneously measure the temperature values, as taught by ‘T Hooft, because this provides an easier method to rapidly perform readings along an artery, as recognized by ‘T Hooft [0006].
Regarding Claim 14, the combination of references teaches the invention substantially as claimed. Pijls fails to explicitly teach determining the first location and the second location based on the plurality of temperature values measured at the plurality of locations along the length of the blood vessel.
‘T Hooft further teaches wherein the temperature values determining processor  [0063] is further configured to: determine the first location and the second location based on the plurality of temperature values measured at the plurality of locations along the length of the blood vessel [0030]-[0031]+[0044].
It would have been obvious to one of ordinary skill in the art to modify the system of Pijls to so determines the locations based on the temperatures, as taught by ‘T Hooft, because this provides an easier method to rapidly perform readings along an artery, as recognized by ‘T Hooft [0006].
Regarding Claim 17, the Patent teaches a non-transitory computer-readable storage medium having stored a computer program comprising instructions for determining blood flow within a blood vessel, the instructions, when executed by a processor (Claim 10), cause the processor to:
while a fluid is infused into the blood vessel at an infusion rate (Claim 9, Col 16, lines 14-15):
receive a plurality of temperature values measured at a plurality of locations along a length of the blood vessel (Claim 9, Col 16, lines 11-23),
determine, based on the plurality of temperature values, a first temperature value at a first location along the length of the blood vessel (Claim 9, Col 16, lines 10-15), the first temperature value indicating temperature of the fluid,
determine, based on the plurality of temperature values, a second temperature value at a second location along the length of the blood vessel (Claim 9, Col 16, lines 16-23), the second temperature value indicating temperature of a mixture of the fluid and blood within the blood vessel, and
determine the blood flow based on the first temperature value, the second temperature value, and the infusion rate (Claim 9, Col 16, lines 24-32).
The Patent fails to explicitly teach at least one sensor continuously infusing a fluid, the first temperature value indicating temperature of the fluid, and the second temperature value indicating temperature of the mixture.
Pijls teaches continuously infusing a fluid [0009], the first temperature value indicating temperature of the fluid with at least one sensor [0033], and the second temperature value indicating temperature of the mixture [0032].
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the Patent to infuse the fluid and measure the temperatures, as taught by Pijls, because this enhances the usefulness of blood flow measurements, as recognized by Pijls [0006].
The combination fails to explicitly teach that the at least one sensor is configured to simultaneously measure a plurality of temperature values to determine a temperature profile along the length of the blood vessel.
‘T Hooft teaches a system for measuring blood flow in the body (Abstract). This system contains a sensor which is configured to simultaneously measure a plurality of temperature values [0010]-[0011] to determine a temperatures profile along the length of the blood vessel [0050]+[0057].
It would have been obvious to one of ordinary skill in the art to modify the combined system to use the temperature sensor to simultaneously measure the temperature values, as taught by ‘T Hooft, because this provides an easier method to rapidly perform readings along an artery, as recognized by ‘T Hooft [0006].
Regarding Claim 18, the combination of references teaches the invention substantially as claimed. Pijls fails to explicitly teach wherein the instructions, when executed by the processor, further cause the processor to: determine the first location and the second location based on the plurality of temperature values measured at the plurality of locations along the length of the blood vessel.
‘T Hooft further teaches wherein the temperature values determining processor  [0063] is further configured to: determine the first location and the second location based on the plurality of temperature values measured at the plurality of locations along the length of the blood vessel [0030]-[0031]+[0044].
It would have been obvious to one of ordinary skill in the art to modify the system of Pijls to so determines the locations based on the temperatures, as taught by ‘T Hooft, because this provides an easier method to rapidly perform readings along an artery, as recognized by ‘T Hooft [0006].
Claims 6-7 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1,and 6, of U.S. Patent No. 11,564,584in view of Pijls, ‘T Hooft, and Van Der Mark et al.
Regarding Claim 6, the combination of references teaches the invention substantially as claimed. The Patent fails to explicitly teach a property sensor configured to generation a sensing signal based on a property to be sensed within the blood vessel
Pijls further teaches a property sensor configured to generation a sensing signal based on a property to be sensed within the blood vessel [0038] ([0027] shows the pressure sensor outputs a sensing signal).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the Patent to integrate the sensor, as taught by Pijls, because this enhances the usefulness of blood flow measurements, as recognized by Pijls [0006].
Pijls fails to explicitly teach a power generator configured to power the property sensor by light received from the optical fiber, wherein the optical fiber is configured to transmit the sensing signal outside of the blood vessel.
Van Der Meek teaches an optical probe system (Abstract). This system has a power generator that powers property sensors [0020]-[0021] by light received from an optical fiber [0025]. The optical fiber system can be used with a pressure sensor [0054], and can transmit the obtained signal to a control unit which is outside of the blood vessel (Fig. 1, 21) [0090]-[0091].
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the combined system to have a power generator, as taught by Van Der Meek, because this provides a faster, more accurate probe for obtaining data, as recognized by Van Der Meek [0014].
Regarding Claim 7, the combination of references teaches the invention substantially as claimed. The Patent fails to explicitly teach the property sensor is configured to generate a pressure sensing signal indicating pressure in the blood and the system further comprises a resistance determination processor configured to determine resistance based on the pressure indicated by the pressure sensing signal and the determined blood flow.
Pijls further teaches the property sensor is configured to generate a pressure sensing signal indicating pressure in the blood [0038]; and the system further comprises a resistance determination processor [0027] configured to determine resistance based on the pressure indicated by the pressure sensing signal and the determined blood flow [0025]+[0039].
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the Patent to use the property sensor, as taught by Pijls, because this enhances the usefulness of blood flow measurements, as recognized by Pijls [0006].
Claims 12, 16, and 20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, and  6, of U.S. Patent No. 11,564,584in view of Pijls, ‘T Hooft, and Yang.
Regarding Claim 12, the combination of references teaches the invention substantially as claimed. The combination fails to explicitly teach an assessment processor configured to determine a quality value indicating quality of determining the blood flow based on a variation of the blood flow determined over time.
Yang teaches a system for determining blood flow (Abstract). This system uses a processor (Fig. 1, flow meter) to determine a quality value (coefficient of variability) which indicates a quality (the reproducibility) of the blood flow based on variation of the blood flow over time (Pg. 72, The Random Component).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the combined system to determine a quality value, as taught by Yang, because knowing the variability of the measurement helps to quantify the precision error of the measurement, thereby improving the clinician’s ability to interpret the data, as recognized by Yang (Abstract).
Regarding Claim 16, the combination of references teaches the invention substantially as claimed. The combination fails to explicitly teach determining a quality value indicating quality of determining the blood flow based on a variation of the blood flow determined over time.
Yang teaches a system for determining blood flow (Abstract). This system uses a processor (Fig. 1, flow meter) to determine a quality value (coefficient of variability) which indicates a quality (the reproducibility) of the blood flow based on variation of the blood flow over time (Pg. 72, The Random Component).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the combined system to determine a quality value, as taught by Yang, because knowing the variability of the measurement helps to quantify the precision error of the measurement, thereby improving the clinician’s ability to interpret the data, as recognized by Yang (Abstract).
Regarding Claim 20, the combination of references teaches the invention substantially as claimed. The combination fails to explicitly teach wherein the instructions, when executed by the processor, further cause the processor to: determine a quality value indicating quality of determining the blood flow based on a variation of the blood flow determined over time.
Yang teaches a system for determining blood flow (Abstract). This system uses a processor (Fig. 1, flow meter) to determine a quality value (coefficient of variability) which indicates a quality (the reproducibility) of the blood flow based on variation of the blood flow over time (Pg. 72, The Random Component).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the combined system to determine a quality value, as taught by Yang, because knowing the variability of the measurement helps to quantify the precision error of the measurement, thereby improving the clinician’s ability to interpret the data, as recognized by Yang (Abstract).
Allowable Subject Matter
Claims 10-11, 15, and 19 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.
Claim 10 recites “an assessment processor configured to determine a quality value indicating a degree of mixing of the fluid and the blood based on the plurality of temperature values measured at the plurality of locations along the length of the blood vessel”. This, in combination with the other limitations, is not taught by the prior art without the benefit of improper hindsight. While Pijls teaches infusing the blood with saline, Pijls does not teach “determine a quality value indicating a degree of mixing of the fluid and the blood based on the plurality of temperature values measured at the plurality of locations along the length of the blood vessel”. Neither ‘T Hooft, Van Der Mark, nor Yang teach the claimed limitations. Therefore, claim 10 is non-obvious over the prior art and would be allowable if rewritten in independent form including all of the limitations of the base claim. Claims 15 and 19 contain similar limitations, and would be allowable for the same reasons. Claim 11 necessarily contains all the limitations claim 10, and also would be allowable by virtue of its dependency.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Goedje et al. (U.S PGPub 2011/0238020 A1), which teaches a fiber optic device for making thermodilution measurements.

APPLICANT REBUTTAL: REMARKS
The Examiner is thanked for indicating that claims 10-11, 15 and 19 would be allowable if rewritten in independent form including all the limitations of the base claim and any intervening claims.
Claim Rejections - 35 U.S.C.
§
Claims 1-5, 8-9, 13-14 and 17-18 were rejected under 35 U.S.C. § 103 as being unpatentable over Pijls (US 2007/0078352), in view of 'T Hooft (US 2014/0194757).
Claims 6-7 were rejected under 35 U.S.C. § 103 as being unpatentable over Pijls in view of 'T Hooft as applied to claim 2 above, and in further view of Van Der Mark (US 2015/0335231).
Claims 12, 16 and 20 were rejected under 35 U.S.C. § 103 as being unpatentable over
Pijls in view of 'T Hooft as applied to claim 1 above, and in further view of Yang ("Determination of the precision error of the pulmonary artery thermodilution catheter using an in vitro continuous flow rest rig").
Double Patenting
Claims 1-5, 8-9, 13-14 and 17-18 were rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 6, 9 and 10 of U.S. Patent No. 11,564,584., in view of Pijls and 'T Hooft.
Claims 6-7 were rejected on the ground of nonstatutory double patenting as being
unpatentable over claims 1 and 6 of U.S. Patent No. 11,564,584, in view of Pijls, 'T Hooft and Van Der Mark.
Claims 12, 16 and 20 were rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 6 of U.S. Patent No. 11,564,584, in view of Pijls, 'T Hooft and Yang.
As noted above, claim 1 has been amended to include the limitations of claim 10. Claim 13 has been amended to include the limitations of claim 15. Claim 17 has been amended to include the limitations of claim 19. In light of the indication in the Office Action that claims 10, 15, and 19 are directed to allowable subject matter, Applicants respectfully submit that the claims are in condition for allowance and that the § 103 and double patenting rejections are no longer relevant.
CONCLUSION

NEXT OFFICE ACTION: DETAILED ACTION
Reasons for Allowance
Claims 1-9, 11-14, 16-18, and 20 allowed.
The following is an examiner’s statement of reasons for allowance: Claims 1, 13 and 17 were amended to contain the features of claims 10, 15, and 19, respectively. Claims 1, 13 and 17 are allowable for the same reasons set forth on pages 22-23 of the non-final rejection mailed 9/9/2024. Claims 2-9, 11-12, 14, 16-18, and 20 necessarily contain the all the limitations of the allowable independent claims, and are allowable by virtue of their dependency.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee.  Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Conclusion

CITED REFERENCE SUMMARIES: Ref US20070078352A1: Claims:
A method for determining the blood flow in an individual coronary artery of a patient, comprising at least the following steps: positioning a temperature sensor mounted at a distal portion of a guide wire at a distal position in the coronary artery; positioning an infusion catheter in the coronary artery such that the distal end of the infusion catheter is proximally of the temperature sensor; measuring blood temperature; infusing cold indicator fluid with a known infusion rate and known or measurable temperature into the coronary artery using the infusion catheter; measuring the temperature of the mixture of blood and indicator fluid using the temperature sensor; and calculating the coronary blood flow by a formula based on the known and measured quantities.
positioning a temperature sensor mounted at a distal portion of a guide wire at a distal position in the coronary artery;
positioning an infusion catheter in the coronary artery such that the distal end of the infusion catheter is proximally of the temperature sensor;
measuring blood temperature;
infusing cold indicator fluid with a known infusion rate and known or measurable temperature into the coronary artery using the infusion catheter;
measuring the temperature of the mixture of blood and indicator fluid using the temperature sensor; and
calculating the coronary blood flow by a formula based on the known and measured quantities.
The method according to claim 1 , further comprising the step of retracting the temperature sensor until the temperature sensor is located inside the infusion catheter and measuring the indicator fluid temperature at the end of the infusion catheter.
The method according to claim 1 , further comprising the step of inducing steady state hyperaemia in the patient before temperature measurement such that the calculated coronary blood flow is the maximum coronary blood flow.
The method according to claim 3 , wherein the formula used for calculating the coronary blood flow is:
Q b = Q k ⁢ T k - T b T - T b
where Q b is the coronary blood flow, Q k is the infusion rate of the indicator fluid, T k is the temperature of the indicator fluid, T b is blood temperature, and T is the temperature of the mixture of blood and indicator fluid.
The method according to claim 1 , wherein the formula used for calculating the coronary blood flow is:
Q b = Q k ⁢ T - T k T b - T
A method for determining the blood flow in an individual coronary artery of a patient and for relating this blood flow to at least one related flow value or to at least one related FFR value, comprising at least the following steps: positioning a temperature sensor mounted at a distal portion of a guide wire at a distal position in the coronary artery; positioning an infusion catheter in the coronary artery such that the distal end of the infusion catheter is proximally of the temperature sensor; inducing steady state hyperaemia in the patient; measuring the blood temperature with the temperature sensor; infusing cold indicator fluid with a known infusion rate and known or measurable temperature into the coronary artery using the infusion catheter; measuring the temperature of the mixture of blood and indicator fluid using the temperature sensor; calculating the maximum coronary blood flow by a formula based on the known and measured quantities; positioning a pressure sensor mounted at a distal portion of a guide wire at a distal position in the coronary artery; measuring a distal pressure by the pressure sensor; measuring the aortic pressure; calculating a first FFR value based on the measured aortic and distal pressures; and calculating a related flow value, or a related FFR value, based on the calculated maximum coronary blood flow and the first FFR value, or a related flow resistance based on the measured pressures and a calculated flow value
inducing steady state hyperaemia in the patient;
measuring the blood temperature with the temperature sensor;
measuring the temperature of the mixture of blood and indicator fluid using the temperature sensor;
calculating the maximum coronary blood flow by a formula based on the known and measured quantities;
positioning a pressure sensor mounted at a distal portion of a guide wire at a distal position in the coronary artery;
measuring a distal pressure by the pressure sensor;
measuring the aortic pressure;
calculating a first FFR value based on the measured aortic and distal pressures; and
calculating a related flow value, or a related FFR value, based on the calculated maximum coronary blood flow and the first FFR value, or a related flow resistance based on the measured pressures and a calculated flow value
The method according to claim 6 , further comprising the step of retracting the temperature sensor until the temperature sensor is located inside the infusion catheter and measuring the indicator fluid temperature at the end of the infusion catheter.
The method according to claim 6 , wherein the temperature measurements and the measurement of the distal pressure are executed with the same guide wire mounted sensor.
The method according to claim 6 , wherein the temperature measurements, the measurement of the distal pressure, and the measurement of the aortic pressure are executed with the same guide wire mounted sensor.
The method according to claim 6 , wherein the measurement of the aortic pressure is executed with a pressure transducer connected to a guide catheter inserted into the patient's aorta.
The method according to claim 6 , further comprising the step of inserting a catheter into the right atrium of the patient's heart and measuring the venous pressure by a pressure transducer connected to the catheter.
The method according to claim 6 , further comprising the step of positioning a balloon arranged at a catheter to a position proximally of the pressure sensor, inflating the balloon to completely occlude the coronary artery, and measuring the coronary wedge pressure using the pressure sensor.
The method according to claim 1 , further comprising the step of measuring the blood temperature with the temperature sensor.
The method according to claim 1 , wherein the infusing comprises continuous infusing.
A system for determining the blood flow in an individual coronary artery of a patient, comprising: a sensor guide wire having a distal portion provided with a temperature sensor and being adapted for positioning in the individual coronary artery; an infusion catheter adapted for positioning in a coronary artery and adapted for injecting an indicator fluid into the individual coronary artery; a device for transforming an output signal from the temperature sensor into a temperature of the medium surrounding the sensor; and a device adapted to be connected to the infusion catheter for continuously delivering a cold indicator fluid from a reservoir into the individual coronary artery.
a sensor guide wire having a distal portion provided with a temperature sensor and being adapted for positioning in the individual coronary artery;
an infusion catheter adapted for positioning in a coronary artery and adapted for injecting an indicator fluid into the individual coronary artery;
a device for transforming an output signal from the temperature sensor into a temperature of the medium surrounding the sensor; and
a device adapted to be connected to the infusion catheter for continuously delivering a cold indicator fluid from a reservoir into the individual coronary artery.
The system according to claim 15 , further comprising a sensor guide wire having a distal portion provided with a pressure sensor and being adapted for positioning in the individual coronary artery.
The system according to claim 16 , wherein the pressure sensor and the temperature sensor are provided at the same guide wire.
Ref US20140194757A1: Claims:
A medical system for interventional measurement of blood flow in an artery (AT), the medical system comprising an interventional device (IVD) comprising at least one optical fiber (FB) comprising a plurality of temperature-sensitive optical sensor segments spatially distributed along its longitudinal extension, wherein the interventional device (IVD) is configured for insertion into an artery (AT) such that the optical fiber (FB) can be positioned inside the artery (AT) and be in thermal contact with blood flowing in the artery (AT), and such that the longitudinal extension of the optical fiber (FB) follows a longitudinal extension of the artery (AT), wherein the interventional device (IVD) comprises a temperature changer (TC) arranged to introduce a local change in temperature (ΔT) of a bolus of blood in the artery (AT) at a position upstream from one end of the optical fiber (FB), a measurement unit (MU) arranged for operational connection to the interventional device (IVD), wherein the measurement unit (MU) comprises a light source (LS) for delivering light to the optical fiber (FB) in the interventional device (IVD), and wherein the measurement unit (MU) is arranged to receive light reflected from the optical fiber (FB) and to generate a corresponding time varying output signal, and a processor unit (PU) for operational connection to the measurement unit (MU), wherein the processor unit (PU) is arranged to run a first processing algorithm (A1) so as to translate the time varying output signal from the measurement unit (MU) into a set of temperatures corresponding to temperatures at respective positions along the optical fiber (FB), and wherein the processor unit (PU) is arranged to run a second processing algorithm (A2) arranged to calculate a measure of blood flow (BF) at respective positions along the optical fiber (FB) in accordance with a temporal behavior of said set of temperatures.
an interventional device (IVD) comprising at least one optical fiber (FB) comprising a plurality of temperature-sensitive optical sensor segments spatially distributed along its longitudinal extension, wherein the interventional device (IVD) is configured for insertion into an artery (AT) such that the optical fiber (FB) can be positioned inside the artery (AT) and be in thermal contact with blood flowing in the artery (AT), and such that the longitudinal extension of the optical fiber (FB) follows a longitudinal extension of the artery (AT), wherein the interventional device (IVD) comprises a temperature changer (TC) arranged to introduce a local change in temperature (ΔT) of a bolus of blood in the artery (AT) at a position upstream from one end of the optical fiber (FB),
a measurement unit (MU) arranged for operational connection to the interventional device (IVD), wherein the measurement unit (MU) comprises a light source (LS) for delivering light to the optical fiber (FB) in the interventional device (IVD), and wherein the measurement unit (MU) is arranged to receive light reflected from the optical fiber (FB) and to generate a corresponding time varying output signal, and
a processor unit (PU) for operational connection to the measurement unit (MU), wherein the processor unit (PU) is arranged to run a first processing algorithm (A1) so as to translate the time varying output signal from the measurement unit (MU) into a set of temperatures corresponding to temperatures at respective positions along the optical fiber (FB), and wherein the processor unit (PU) is arranged to run a second processing algorithm (A2) arranged to calculate a measure of blood flow (BF) at respective positions along the optical fiber (FB) in accordance with a temporal behavior of said set of temperatures.
System according to claim 1 , wherein the measurement unit (MU) comprises an interferometer.
System according to claim 1 , comprising a temperature control unit arranged to temporally control a temperature changing effect of the temperature changer (TC).
System according to claim 3 , wherein the temperature control unit is arranged to control the temperature changer (TC) so as to provide a modulation of cooling or heating of the local bolus of blood at a constant frequency, and wherein the measurement unit (MU) is arranged to measure a spatially distributed temperature at said frequency.
System according to claim 1 , wherein the temperature changer (TC) comprises a catheter (C) arranged for injection of a temporally limited bolus of liquid with a temperature different (ΔT) from a temperature of blood in the artery (AT).
System according to claim 1 , wherein the temperature changer (TC) comprises a temperature changing element arranged for thermal contact with blood in the artery (AT), wherein the temperature changing element is arranged to cool or heat a local bolus of blood.
System according to claim 1 , wherein the plurality of temperature-sensitive optical sensor segments comprises at least one of: Fiber Bragg Gratings, and Rayleigh based sensor segments.
System according to claim 1 , wherein the interventional device (IVD) comprises a guidewire in which the at least one optical fiber (FB) is arranged.
System according to claim 1 , wherein the light source (LS) comprises a laser light source arranged to provide light at different wavelengths.
System according to claim 9 , wherein light from the light source (LS) is split into a first part delivered to the optical fiber (FB) in the interventional device (IVD) and into a second part applied to a wavelength measurement unit arranged to determine a measure of wavelength of the light from the light source (LS).
System according to claim 10 , wherein the wavelength measurement unit comprises a gas cell (GC) with a known optical absorption spectrum, and a Mach Zehnder interferometer.
System according to claim 1 , wherein the first processing algorithm (Al) comprises spatially resolving the output signal as a function of time from the measurement unit into a distributed temperature profile by means of Fourier analysis.
System according to claim 1 , wherein the interventional device (IVD) and the measurement unit (MU) are arranged for interconnection by means of an optical interface so as to allow the measurement unit (MU) and the interventional device (IVD) to be spatially separated during normal use.
System according to claim 1 , wherein the interventional device (IVD) is made of non-magnetic materials.
Method for minimally-invasive measurement of blood flow in an artery, the method comprising providing an interventional device comprising at least one optical fiber comprising a plurality of temperature-sensitive optical sensor segments spatially distributed along its longitudinal extension, wherein the interventional device comprises a temperature changer, inserting the interventional device into an artery such that the optical fiber can be positioned inside the artery and be in thermal contact with blood flowing in the artery, and such that the longitudinal extension of the optical fiber follows a longitudinal extension of the artery, introducing a local change in temperature of a bolus of blood in the artery at a position upstream from one end of the optical fiber by means of the temperature changer, delivering light to the optical fiber in the interventional device, receiving light reflected from the optical fiber, translating the time varying reflected light into a set of temperatures corresponding to temperatures at respective positions along the optical fiber, and calculating a measure of blood flow at respective positions along the optical fiber in accordance with a temporal behavior of said set of temperatures.
providing an interventional device comprising at least one optical fiber comprising a plurality of temperature-sensitive optical sensor segments spatially distributed along its longitudinal extension, wherein the interventional device comprises a temperature changer,
inserting the interventional device into an artery such that the optical fiber can be positioned inside the artery and be in thermal contact with blood flowing in the artery, and such that the longitudinal extension of the optical fiber follows a longitudinal extension of the artery,
introducing a local change in temperature of a bolus of blood in the artery at a position upstream from one end of the optical fiber by means of the temperature changer,
delivering light to the optical fiber in the interventional device,
receiving light reflected from the optical fiber,
translating the time varying reflected light into a set of temperatures corresponding to temperatures at respective positions along the optical fiber, and
calculating a measure of blood flow at respective positions along the optical fiber in accordance with a temporal behavior of said set of temperatures.
Ref US20150335231A1: Claims:
An optical probe system, the system comprising: a radiation source capable of emitting a first radiation beam, said first radiation beam comprising optical energy (O_P) and first data (D_F), a photodetector, the photodetector being arranged for detecting a second radiation beam, and an optical probe, the optical probe being at its proximal end optically connected to the photodetector and the radiation source, the probe having an optical guide capable of connecting the distal end with the proximal end, the optical probe having at its distal end an optical converter circuit, said circuit comprising: an application device, the application device being arranged for monitoring and/or manipulation at the distal end of the probe, the application device being arranged for generating second data (D_R) indicative of the functionality of the application device, and an optoelectronic device, the optoelectronic device being arranged for converting said first radiation beam into electrical energy and for receiving said first data, the first data being related to the functionality of the application device, the optoelectronic device further being arranged for emitting said second radiation beam towards the photodetector, the second radiation beam comprising the second data, the optoelectronic device further being arranged for: converting said first radiation beam into electrical energy and for receiving said first data, and emitting said second radiation beam towards the photodetector, said emission being inducible by the incoming first radiation beam, wherein the optical converter circuit is powerable by said electric energy in the first radiation beam.
a radiation source capable of emitting a first radiation beam, said first radiation beam comprising optical energy (O_P) and first data (D_F),
a photodetector, the photodetector being arranged for detecting a second radiation beam, and
an optical probe, the optical probe being at its proximal end optically connected to the photodetector and the radiation source, the probe having an optical guide capable of connecting the distal end with the proximal end, the optical probe having at its distal end an optical converter circuit, said circuit comprising: an application device, the application device being arranged for monitoring and/or manipulation at the distal end of the probe, the application device being arranged for generating second data (D_R) indicative of the functionality of the application device, and an optoelectronic device, the optoelectronic device being arranged for converting said first radiation beam into electrical energy and for receiving said first data, the first data being related to the functionality of the application device, the optoelectronic device further being arranged for emitting said second radiation beam towards the photodetector, the second radiation beam comprising the second data,
an application device, the application device being arranged for monitoring and/or manipulation at the distal end of the probe, the application device being arranged for generating second data (D_R) indicative of the functionality of the application device, and
an optoelectronic device, the optoelectronic device being arranged for converting said first radiation beam
[Truncated to input limit]