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 .
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following figures mentioned in the description: Paragraph 74 of the published specification discloses “linear models shown in FIGS. 5 and 7”. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claims 2, 15, and 21 are objected to because of the following informalities:
In claim 2 “at least one of blood flow rate and blood flow velocity” should be changed to “at least one of the blood flow rate and the blood flow velocity” because it is clear the Applicant intended to refer to the previously set forth blood flow rate and blood flow velocity.
In claim 15 “at least one of blood flow rate and blood flow velocity” should be changed to “at least one of the blood flow rate and the blood flow velocity” because it is clear the Applicant intended to refer to the previously set forth blood flow rate and blood flow velocity.
In claim 21 “the one or more generated linear models” should be changed to “the one or more obtained linear models” or “the one or more .
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 8-9 and 21-22 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding claims 8-9 and 21-22, the claims forth that " obtaining one or more linear models based on the time series analysis, wherein the one or more linear models provide an estimated flow rate at a selected lag time; and inputting a result of the time series analysis for the captured reflected light at the selected lag time into the one or more linear models to determine a flow rate corresponding to the result of the time series analysis". This is understood to be a computer-implemented functional limitation which requires disclosure of the underlying algorithm(s) for obtaining the result in order to comply with the written description requirement. See MPEP § 2161.01(1). While the published specification provides literal support for extracting values "obtain one or more linear models based on the time series analysis, wherein the one or more generated linear models provide an estimated flow rate at a selected lag time; and to input a result of the time series analysis for the captured reflected light at the selected lag time into the one or more linear models to determine a flow rate corresponding to the result of the correlation analysis" as in [0025] [0026] [0072], there is no description as to how the time series analysis is input into the model, what the models do with the time series analysis data to estimate flow rate a given lag time, and what the models do with the time series analysis data to determine flow rate. The specification references Figures 5 and 7 as examples of this model but Figure 7 does not exist, and Figure 5 also does not describe how the time series analysis is input into the model, what the models do with the time series analysis data to estimate flow rate a given lag time, and what the models do with the time series analysis data to determine flow rate. For this reason, applicant has failed to comply with the written description requirement for this computer-implemented function.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 21 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 21, claim 12 recites the limitation “the correlation analysis” in the last two lines. There is insufficient antecedent basis for this limitation in the claim. No correlation analysis has previously been set forth. For examination purposes, this limitation will be interpreted as reciting “the time series analysis” as that is consistent with analogous claim 8 and the specification.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-7 and 14-20 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Tearney et al. (US20110137140, hereafter Tearney).
Regarding claims 1 and 14, Tearney discloses method and system for evaluating characteristics of a blood vessel and/or of blood flowing within the blood vessel (Tearney, Para 2; “Exemplary embodiments of the present disclosure relates generally to measuring apparatus, systems and methods, and more particularly to apparatus, systems and methods for measuring flow and pressure within a vessel.”) (Tearney, Para 13; “For example, the characteristic(s) can comprise particular parameters which includes flow, viscosity, density, velocity, coronary flow reserve, fractional flow reserve, coronary flow velocity reserve, average peak velocity, maximum peak velocity, average velocity and/or pressure of the fluid within the vessel. The characteristic(s) can comprise a multi-dimensional distribution of the particular parameters. The third arrangement can determine the characteristic(s) at multiple longitudinal locations within the vessel. The third arrangement(s) can determine the characteristic(s) at least one proximal or distal to stenosis or blockage. The third arrangement(s) can be further configured to determine the property and/or a geometry of a wall of the vessel. The property of the wall can be a luminal contour or a bio-mechanical property of the wall, or a tissue characteristic of the wall. The third arrangement(s) can determine at least one characteristic of a wall of the vessel.”), the method and system comprising:
an intravascular catheter with a light delivery portion (Tearney, Para 12; “For example, it is possible to use at least one first probe arrangement structured to be insertable into a vessel and configured to direct at least one radiation to at least one portion of the anatomical structure.”) (Tearney, Para 13; “The first probe arrangement(s) can include a catheter, a wire and/or a sheath. The fluid can comprise blood, transparent medium, and/or a combination thereof. The fluid can comprise \blood, transparent medium, and/or a combination thereof. A wavelength of at least one of the first radiation or the second radiation can vary over time.”) and a light capture portion (Tearney, Para 13; “The second arrangement can include at least one array of detectors, each configured to detect a separate wavelength band of the interference.”) (Tearney, Para 28; “For example, FIG. 1A illustrates such exemplary OCT catheter, system and/or arrangement which includes certain exemplary mechanical and/or optical elements that can be utilized in various exemplary catheter designs and/or configuration.”) (Tearney, Para 34; “. In yet another embodiment, the flow velocity information can be acquired proximally to the catheter, within the penetration depth of the OFDI or SD-OCT light and structural information regarding the artery wall is also obtained using intravascular imaging with the OFDI or SD-OCT light or via another imaging means such as angiography, CT, or IVUS known in the art.”); and
a controller coupled to each of the light delivery portion and the light capture portion of the catheter (Tearney, Para 28; “In particular, as shown in FIG. 1A, the exemplary OCT catheter, system and/or arrangement can include an inner core 100, which can contain at least one fiber optic arrangement 75 (e.g., an optical fiber configuration which can include one or more fibers) that is coupled to an OCT system, apparatus or arrangement 50 which can include a processor and a storage medium (e.g., hard drive, CD-ROM, floppy disk, memory stick, combination thereof, etc) at a proximal end thereof (e.g., via an optical rotary junction 100), and can focus and redirect the light at a distal end 110 thereof.”), wherein the controller is programmed to execute a procedure comprising:
(a) delivering light at one or more wavelengths into the blood vessel using the light delivery portion of the catheter (Tearney, Para 12; “For example, it is possible to use at least one first probe arrangement structured to be insertable into a vessel and configured to direct at least one radiation to at least one portion of the anatomical structure.”) (Tearney, Para 13; “The first probe arrangement(s) can include a catheter, a wire and/or a sheath. The fluid can comprise blood, transparent medium, and/or a combination thereof. The fluid can comprise \blood, transparent medium, and/or a combination thereof. A wavelength of at least one of the first radiation or the second radiation can vary over time.”);
(b) capturing reflected light at each of the one or more wavelengths and generating a signal corresponding to light captured at each of the one or more wavelengths using the light capturing portion of the catheter (Tearney, Para 13; “The second arrangement can include at least one array of detectors, each configured to detect a separate wavelength band of the interference.”) (Tearney, Para 28; “For example, FIG. 1A illustrates such exemplary OCT catheter, system and/or arrangement which includes certain exemplary mechanical and/or optical elements that can be utilized in various exemplary catheter designs and/or configuration.”) (Tearney, Para 34; “. In yet another embodiment, the flow velocity information can be acquired proximally to the catheter, within the penetration depth of the OFDI or SD-OCT light and structural information regarding the artery wall is also obtained using intravascular imaging with the OFDI or SD-OCT light or via another imaging means such as angiography, CT, or IVUS known in the art.”); and
(c) determining at least one of blood flow rate and blood flow velocity within the blood vessel from the signal generated in step (b) by the light capturing portion of the catheter (Tearney, Para 12-13; “Further, at least one third arrangement can be provided which is configured to determine at least one characteristic of the fluid as a function of the interference. The third arrangement can determine the characteristic(s) as a function of an intensity of the interference. For example, the characteristic(s) can comprise particular parameters which includes flow, viscosity, density, velocity, coronary flow reserve, fractional flow reserve, coronary flow velocity reserve, average peak velocity, maximum peak velocity, average velocity and/or pressure of the fluid within the vessel.”).
Regarding claims 2 and 15, Tearney discloses all of the limitations of claims 1 and 14 as discussed above.
Tearney further discloses (d) determining at least one of a wall sheer stress level and/or fractional flow reserve ratio for the blood vessel from the at least one of blood flow rate and blood flow velocity determined in step (c) (Tearney, Para 35; “In another exemplary embodiment of the present disclosure, the vessel geometry information may be measured as a function of time to obtain biomechanical information such as shear stress using geometrical methods known in the art and the flow velocity information may be measured as a function of at least one of biomechanical information, spatial location, and time.”) (Tearney, Para 9; “it is another object of an additional exemplary embodiment of the present disclosure to convert the OCT flow and pressure information into derived clinical parameters coronary flow reserve (CFR), Fractional Flow Reserve (FFR), Average Peak Velocity (APV) and other metrics known to those having ordinary skill the art”).
Regarding claims 3 and 16, Tearney discloses all of the limitations of claims 1 and 14 as discussed above.
Tearney further discloses wherein the light delivery portion comprises a first optical guide extending along the catheter and the light capturing portion comprises a second optical guide extending along the catheter, and wherein the first optical guide is the same as or different than the second optical guide (Figure 1A and 6A-6B) (Tearney, Para 28; “particular, as shown in FIG. 1A, the exemplary OCT catheter, system and/or arrangement can include an inner core 100, which can contain at least one fiber optic arrangement 75 (e.g., an optical fiber configuration which can include one or more fibers) that is coupled to an OCT system, apparatus or arrangement 50 which can include a processor and a storage medium (e.g., hard drive, CD-ROM, floppy disk, memory stick, combination thereof, etc) at a proximal end thereof (e.g., via an optical rotary junction 100), and can focus and redirect the light at a distal end 110 thereof.”) (Tearney, Para 35; “shown in FIG. 6 A, the exemplary OFDI catheter 600, used to obtain information from the artery wall 610 can contain an additional apparatus 620 that facilitates the measurement of intraluminal pressure. This exemplary apparatus may contain an optical fiber 621 […] this optical sensor utilizes the same or similar source of electromagnetic radiation as the imaging or flow velocity measurement electromagnetic radiation.”) (Tearney, Para 13; “The second arrangement can include at least one array of detectors, each configured to detect a separate wavelength band of the interference.”) (Tearney, Para 28; “For example, FIG. 1A illustrates such exemplary OCT catheter, system and/or arrangement which includes certain exemplary mechanical and/or optical elements that can be utilized in various exemplary catheter designs and/or configuration.”) (Tearney, Para 34; “. In yet another embodiment, the flow velocity information can be acquired proximally to the catheter, within the penetration depth of the OFDI or SD-OCT light and structural information regarding the artery wall is also obtained using intravascular imaging with the OFDI or SD-OCT light or via another imaging means such as angiography, CT, or IVUS known in the art.”).
Regarding claims 4 and 17, Tearney discloses all of the limitations of claims 3 and 16 as discussed above.
Tearney further discloses wherein the light delivery portion comprises an LED and/or laser coupled to the first optical guide and the light capturing portion comprises a photodetector coupled to the second optical guide (Figure 1A and 6A-6B) (Tearney, Para 28; “particular, as shown in FIG. 1A, the exemplary OCT catheter, system and/or arrangement can include an inner core 100, which can contain at least one fiber optic arrangement 75 (e.g., an optical fiber configuration which can include one or more fibers) that is coupled to an OCT system, apparatus or arrangement 50 which can include a processor and a storage medium (e.g., hard drive, CD-ROM, floppy disk, memory stick, combination thereof, etc) at a proximal end thereof (e.g., via an optical rotary junction 100), and can focus and redirect the light at a distal end 110 thereof.”) (Tearney, Para 35; “shown in FIG. 6 A, the exemplary OFDI catheter 600, used to obtain information from the artery wall 610 can contain an additional apparatus 620 that facilitates the measurement of intraluminal pressure. This exemplary apparatus may contain an optical fiber 621 […] this optical sensor utilizes the same or similar source of electromagnetic radiation as the imaging or flow velocity measurement electromagnetic radiation.”) (Tearney, Para 13; “The second arrangement can include at least one array of detectors, each configured to detect a separate wavelength band of the interference.”) (Tearney, Para 28; “For example, FIG. 1A illustrates such exemplary OCT catheter, system and/or arrangement which includes certain exemplary mechanical and/or optical elements that can be utilized in various exemplary catheter designs and/or configuration.”) (Tearney, Para 34; “. In yet another embodiment, the flow velocity information can be acquired proximally to the catheter, within the penetration depth of the OFDI or SD-OCT light and structural information regarding the artery wall is also obtained using intravascular imaging with the OFDI or SD-OCT light or via another imaging means such as angiography, CT, or IVUS known in the art.”).
Regarding claims 5 and 18, Tearney discloses all of the limitations of claims 1 and 14 as discussed above.
Tearney further discloses wherein the light delivery portion comprises a light source located at an optical interface of the catheter, and the light capturing portion comprises a light detector located at the optical interface (Figure 1A and 6A-6B) (Tearney, Para 28; “particular, as shown in FIG. 1A, the exemplary OCT catheter, system and/or arrangement can include an inner core 100, which can contain at least one fiber optic arrangement 75 (e.g., an optical fiber configuration which can include one or more fibers) that is coupled to an OCT system, apparatus or arrangement 50 which can include a processor and a storage medium (e.g., hard drive, CD-ROM, floppy disk, memory stick, combination thereof, etc) at a proximal end thereof (e.g., via an optical rotary junction 100), and can focus and redirect the light at a distal end 110 thereof.”) (Tearney, Para 35; “shown in FIG. 6 A, the exemplary OFDI catheter 600, used to obtain information from the artery wall 610 can contain an additional apparatus 620 that facilitates the measurement of intraluminal pressure. This exemplary apparatus may contain an optical fiber 621 […] this optical sensor utilizes the same or similar source of electromagnetic radiation as the imaging or flow velocity measurement electromagnetic radiation.”) (Tearney, Para 13; “The second arrangement can include at least one array of detectors, each configured to detect a separate wavelength band of the interference.”) (Tearney, Para 28; “For example, FIG. 1A illustrates such exemplary OCT catheter, system and/or arrangement which includes certain exemplary mechanical and/or optical elements that can be utilized in various exemplary catheter designs and/or configuration.”) (Tearney, Para 34; “. In yet another embodiment, the flow velocity information can be acquired proximally to the catheter, within the penetration depth of the OFDI or SD-OCT light and structural information regarding the artery wall is also obtained using intravascular imaging with the OFDI or SD-OCT light or via another imaging means such as angiography, CT, or IVUS known in the art.”).
Regarding claims 6 and 19, Tearney discloses all of the limitations of claims 1 and 14 as discussed above.
Tearney further discloses wherein step (c) comprises performing a time series analysis for the signal generated in step (b) by the light capturing portion of the catheter, wherein the time series analysis comprises an autocorrelation and/or autocovariance (Tearney, Para 30-31; “One exemplary embodiment of the present disclosure can provide an exemplary system and/or method is to utilize and existing OCT catheter to obtain flow information. […] This information can be processed according to the exemplary correlation methods, such as at least one of spatial and temporal autocorrelation, of the present disclosure to obtain flow information as a function of distance from the catheter optics and also as a function of time. […] In this exemplary embodiment, Windowed (2.5 msec) autocorrelations along time can be computed for each depth location and for all times. The first zero crossing beyond the main autocorrelation peak is identified. The time constant (exponential fit), which has a relationship to flow velocity, can be computed from the autocorrelation peak (up to the first zero crossing) at each time and depth point. Alternatively, the flow information can be obtained by determining the width of the peak or height of the peak. In another embodiment, the autocorrelation can be fit using a multi-exponential, polynomial, Gaussian, or Lorentzian function or another function known for peak fitting in the art.”).
Regarding claims 7 and 20, Tearney discloses all of the limitations of claims 6 and 19 as discussed above.
Tearney further discloses wherein the time series analysis is conducted for one or more lag times (Tearney, Para 30-31; “One exemplary embodiment of the present disclosure can provide an exemplary system and/or method is to utilize and existing OCT catheter to obtain flow information. […] This information can be processed according to the exemplary correlation methods, such as at least one of spatial and temporal autocorrelation, of the present disclosure to obtain flow information as a function of distance from the catheter optics and also as a function of time. […] In this exemplary embodiment, Windowed (2.5 msec) autocorrelations along time can be computed for each depth location and for all times. The first zero crossing beyond the main autocorrelation peak is identified. The time constant (exponential fit), which has a relationship to flow velocity, can be computed from the autocorrelation peak (up to the first zero crossing) at each time and depth point. Alternatively, the flow information can be obtained by determining the width of the peak or height of the peak. In another embodiment, the autocorrelation can be fit using a multi-exponential, polynomial, Gaussian, or Lorentzian function or another function known for peak fitting in the art.”).
Claims 10 and 23 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Tearney as evidenced by Pijls et al. (Nico H.J. Pijls et al., Fractional Flow Reserve : A Useful Index to Evaluate the Influence of an Epicardial Coronary Stenosis on Myocardial Blood Flow, Circulation Volume 92, Number 11, https://doi.org/10.1161/01.CIR.92.11.3183, Originally Published 1 December 1995, https://www.ahajournals.org/doi/full/10.1161/01.CIR.92.11.3183, hereafter Pijls.
Regarding claims 10 and 23, Tearney discloses all of the limitations of claims 2 and 15 as discussed above.
Tearney further disclose wherein step (d) comprises calculating the fraction flow reserve ratio by: obtaining a hypothetical blood flow velocity within the blood vessel; and comparing the calculated at least one of blood flow rate and blood flow velocity of the blood vessel with the hypothetical blood flow velocity (Tearney, Para 35; “In another exemplary embodiment of the present disclosure, the vessel geometry information may be measured as a function of time to obtain biomechanical information such as shear stress using geometrical methods known in the art and the flow velocity information may be measured as a function of at least one of biomechanical information, spatial location, and time.”) (Tearney, Para 9; “it is another object of an additional exemplary embodiment of the present disclosure to convert the OCT flow and pressure information into derived clinical parameters coronary flow reserve (CFR), Fractional Flow Reserve (FFR), Average Peak Velocity (APV) and other metrics known to those having ordinary skill the art”). A person having ordinary skill would understand that FFR is a ratio of actual flow to a hypothetical referential maximum flow in the artery as evidenced by Pijls. (Pijls, Abstract; “Fractional flow reserve (FFR), defined as the ratio of maximum flow in the presence of a stenosis to normal maximum flow”).
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.
Claims 8 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Tearney and Tamada (US20130165780).
Regarding claims 8 and 21, Tearney discloses all of the limitations of claims 6 and 19 as discussed above.
Tearney does not clearly and explicitly disclose wherein to perform step (c), the controller is programmed to obtain one or more linear models based on the time series analysis, wherein the one or more generated linear models provide an estimated flow rate at a selected lag time; and to input a result of the time series analysis for the captured reflected light at the selected lag time into the one or more linear models to determine a flow rate corresponding to the result of the correlation analysis.
In an analogous diagnostic catheter field of endeavor Tamada discloses obtaining one or more linear models, wherein the one or more linear models provide an estimated flow rate at a selected lag time; and inputting a result of the time series analysis for the captured reflected light at the selected lag time into the one or more linear models to determine a flow rate corresponding to the result of the time series analysis (Tamada, Para 49; “With regard to each of the measurements, linear approximation lines (linear regression lines) which are calculated using a least squares method, where the trend in the characteristic values of the blood flow speed and the blood pressure is a type of regression analysis process, are shown in the diagram in combination with the plotting. It is understood that the slope of the linear regression line is substantially constant for each of the measurements. However, it is understood that the overall sizes of the characteristics values are different for each of the measurements, and as a result, the linear regression line shifts up and down.”) (Tamada, Para 53; “As described above, in the embodiment, the correlation characteristics are approximated using a correlation formula (linear regression line) which is expressed using a linear function. The correlation formula is expressed using a formula which has two parameters of the slope and intercept. In the first correction, the correlation formula is rederived by recalculating both of the two parameters. This is equivalent to rederiving the correlation characteristics by recalculating all of the values of the plurality of parameters in the formula which is expressed by the correlation characteristics.”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify wherein to perform step (c), the controller is programmed to obtain one or more linear models based on the time series analysis, wherein the one or more generated linear models provide an estimated flow rate at a selected lag time; and to input a result of the time series analysis for the captured reflected light at the selected lag time into the one or more linear models to determine a flow rate corresponding to the result of the correlation analysis in order to use as taught by Tamada simpler and easier to interpret analysis that is computationally more efficient.
Claims 9 and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Tearney and Tamada as applied to claims 8 and 21 above, and further in view of Fleming et al. (US20160235303, hereafter Fleming).
Regarding claims 9 and 22, Tearney as modified by Tamada discloses all of the limitations of claims 8 and 21 as discussed above.
Tearney does not clearly and explicitly disclose wherein each of the one or more linear models is associated with a different wavelength of light.
In an analogous diagnostic catheter field of endeavor Fleming discloses wherein e one or more linear models is associated with a different wavelength of light (Fleming, Para 71; "Calibrated spectra were fitted to a wavelength-dependent linear model, and slope values were extracted for comparison.") (Fleming, Para 70; “The exemplary spectra can be calibrated to the instrument response at procedure 410, and the exemplary spectra can be fit to a wavelength dependent linear model at procedure 415.”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Tearney wherein each of the one or more linear models is associated with a different wavelength of light as taught by Fleming in order to increase accuracy.
Claims 11 and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Tearney and Cho (US20100249620).
Regarding claims 11 and 24, Tearney discloses all of the limitations of claims 2 and 15 as discussed above.
Tearney further discloses wherein step (c) comprises determining the blood flow rate (Tearney, Para 13; “For example, the characteristic(s) can comprise particular parameters which includes flow”) and step (d) comprises calculating the wall shear stress (Tearney, Para 35; “the vessel geometry information may be measured as a function of time to obtain biomechanical information such as shear stress”).
Tearney does not clearly and explicitly disclose calculating the wall shear stress by the formula: τ=4μQ/πr3, where: τ represents the wall shear stress; μ (mu) is the dynamic viscosity of blood; and Q is the blood flow rate determined in step (c).
In an analogous blood vessel and blood flow monitoring field of endeavor Cho discloses calculating wall shear stress by the formula: τ=4μQ/πr3, where: τ represents the wall shear stress; μ (mu) is the dynamic viscosity of blood; and Q is the blood flow rate. (Cho, Para 68-69; “Wall shear stress in a human coronary can be estimated by applying Poiseuille's Law as follows: τ=4μQ/πr3, where: τ = wall shear stress in dynes/cm2; Q=coronary blood flow rate; μ=viscosity of the blood in units of poise, and r=the luminal radius at the site of constriction in centimeters.”).
Such a modification amounts to the mere combination of known prior art parts to yield predictable results, which has previously been held to involve no more than routine skill in the art. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Tearney to include calculating the wall shear stress by the formula: τ=4μQ/πr3, where: τ represents the wall shear stress; μ (mu) is the dynamic viscosity of blood; and Q is the blood flow rate determined in step (c) as taught by Cho in order to a known, precise, accurate, and tested mathematical model of fluid dynamics.
Claims 12-13 and 25-26 are rejected under 35 U.S.C. 103 as being unpatentable over Tearney and Kawahara (US20070076220).
Regarding claims 12 and 25, Tearney discloses all of the limitations of claims 1 and 14 as discussed above.
Tearney further discloses wherein the one or more wavelengths include a first wavelength and a second wavelength (Tearney, Para 13; “A wavelength of at least one of the first radiation or the second radiation can vary over time. The second arrangement can include at least one array of detectors, each configured to detect a separate wavelength band of the interference.”).
Tearney does not clearly and explicitly disclose wherein the first wavelength is associated with a first penetration depth and the second wavelength is associated with a second penetration depth, the first penetration depth being less than the second penetration depth.
In an analogous optical diagnostic system field of endeavor Kawahara discloses wherein a first wavelength is associated with a first penetration depth and the second wavelength is associated with a second penetration depth, the first penetration depth being less than the second penetration depth (Kawahara, Para 36; “the measurable range (measuring depth) increases as the wavelength resolution increases and decreases as the wavelength resolution decreases, the user can switch the measurable range (measuring depth) according to the application, whereby the convenience of the optical tomography system is improved, when the interference light detecting means can be switched between a first detecting mode in which the interference light detecting means detects the interference light at a first wavelength resolution and a second detecting mode in which the interference light detecting means detects the interference light at a second wavelength resolution higher than the first wavelength resolution”) (Kawahara, Para 9; “The measurable range (measuring depth) over which a tomographic image […] is reverse proportional to the wavelength band of the low coherence light (the wavelength band of the interference light)”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Tearney wherein the first wavelength is associated with a first penetration depth and the second wavelength is associated with a second penetration depth, the first penetration depth being less than the second penetration depth in order to allow a user to switch between different detection depths as needed, increasing ease of use and convenience as taught by Cho (Cho, Para 36).
Regarding claims 13 and 26, Tearney as modified by Cho above discloses all of the limitations of claims 12 and 25 as discussed above.
Tearney does not clearly and explicitly disclose switching between the first wavelength and the second wavelength by activating a switch.
Kawahara further discloses switching between a first wavelength and a second wavelength by activating a switch (Kawahara, Para 20; “a wavelength bandwidth switching means which switches the wavelength bandwidth of the interference light entering the optical sensor. This wavelength bandwidth switching means switches the wavelength bandwidth so that the wavelength bandwidth of the interference light entering the optical sensor in the second detecting mode is narrower than the wavelength bandwidth of the interference light entering the optical sensor in the first detecting mode”) (Kawahara, Para 36; “the measurable range (measuring depth) increases as the wavelength resolution increases and decreases as the wavelength resolution decreases, the user can switch the measurable range (measuring depth) according to the application, whereby the convenience of the optical tomography system is improved, when the interference light detecting means can be switched between a first detecting mode in which the interference light detecting means detects the interference light at a first wavelength resolution and a second detecting mode in which the interference light detecting means detects the interference light at a second wavelength resolution higher than the first wavelength resolution”) (Kawahara, Para 9; “The measurable range (measuring depth) over which a tomographic image […] is reverse proportional to the wavelength band of the low coherence light (the wavelength band of the interference light)”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Tearney to include switching between the first wavelength and the second wavelength by activating a switch in order to allow a user to switch between different detection depths as needed, increasing ease of use and convenience as taught by Cho (Cho, Para 36).
Conclusion
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/JOHN D LI/Primary Examiner, Art Unit 3798