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 .
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d) to parent Application No. EP18189871.9, filed on EP18189871.9. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 9 June 2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Objections
Claim 1 objected to because of the following informalities: Lines 4-5 should be further indented than line 7. Appropriate correction is required.
Claim 4 objected to because of the following informalities: the claim should recite “wherein the plurality of time delays comprises an individual time delay for each velocity of the first distribution of flow velocities and the second distribution of flow velocities” which is commensurate with ¶ [0139] if the instant specification as published. Appropriate correction is required.
Claim Rejections - 35 USC § 112(a)
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.
Claim 9 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for cross-covariance, does not reasonably provide enablement for cross-variance. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims. In particular, the instant specification discloses in ¶ [0161-0162] describes cross-covariance. However, the instant specification is silent to cross-variance. Accordingly, the instant specification does not teach those skilled in the art how to use the full scope of the claimed invention without undue experimentation; therefore, the instant specification is not commensurate with the scope of protection sought by the claims.
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 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.
Claim 1-11 are rejected under 35 U.S.C. 103 as being unpatentable over Hollender et al. (US PGPUB 20150305717; hereinafter "Hollender") in further view of Shih et al. (“Development of an intravascular ultrasound elastography based on a dual-element transducer,” (25 April 2018), R Soc Open Sci. (2018) 5 (4): 180138; hereinafter "Shih").
With regards to Claim 1, Hollender discloses an apparatus (ultrasound system 10; see Hollender FIG. 1), comprising:
an intravascular probe configured to be positioned within a blood vessel of a patient and comprising an ultrasound transducer (internally inserted ultrasound probe array (such as an ultrasound probe array configured for insertion into an orifice of the body) for evaluating tissue stiffness of blood vessels; see Hollender ¶ [0043 & 0054]) configured to:
transmit a plurality of intravascular ultrasonic pulses from a pulse origin (the shear wave generation module 22 may provide control signals to cause the array 40 to generate a shear wave in the target region 62 (Block 100); see Hollender ¶ [0051-0052]); and
obtain a plurality of echoes from a first location relative to a pulse origin and a second location relative to the pulse origin (transmit tracking pulses in the target region 62 (Block 102) and to receive corresponding echo signals for the tracking pulses in the target region 62 at a plurality of positions (Block 104); see Hollender ¶ [0051]; estimate time-of-flight (ToF) measurements at least two locations Pn on transducer array 40, where each location corresponds to an array element Pn; see Hollender ¶ [0052]); and
a processor (signal analyzer 30; see Hollender FIG. 1) configured to:
determine based on the plurality of echoes:
a first distribution of flow velocities at the first location comprising repeated measurements of a flow velocity at the first location (FIG. 6 illustrates the velocity distribution based on the ToF for a plurality of focal depths t along the transducer in the x-direction; see Hollender ¶ [0076]); and
a second distribution of flow velocities at the second locations comprising repeated measurements of the flow velocity at the second location (FIG. 6 illustrates the velocity distribution based on the ToF for a plurality of focal depths t along the transducer in the x-direction; see Hollender ¶ [0076]);
determine a time delay for propagation of a pulse wave in the blood vessel from the first location to the second location based on the first distribution of flow velocities and the second distribution of flow velocities (averaging a time-of-flight difference and/or velocity estimate of the shear wave for the first and second sets of spatially equivalent positions; see Hollender ¶ [0052]); and
calculate a pulse wave velocity using:
a distance between the first location and the second location (shear wave velocity is calculated based on the time-of-flight delay different ∆t and the know distance between spatially equivalent positions ∆t; see Hollender ¶ [0068] & Eq. 3); and
the time delay (shear wave velocity is calculated based on the time-of-flight delay different ∆t and the know distance between spatially equivalent positions ∆t; see Hollender ¶ [0068] & Eq. 3); and
provide an output based on the pulse wave velocity to a display in communication with the processor (FIG. 6 of Hollender illustrates the output of the velocity distribution as described above).
While Hollender teaches of an internally inserted ultrasound probe array to aid in the quantification of atherosclerosis (see Hollender ¶ [0054]), it appears that Hollender may be silent to a catheter or guidewire. However, Shih teaches of an intravascular ultrasound elastography based on a dual-element transducer in which generates an ARFI pulse and measures the correlated tissue displacement with an imaging element at a known distance from the pushing element, wherein multiple measurements are performed at different positions (see Shih Abstract, FIGS. 1a-1b, & pg. 5, ¶ 2).
Hollender and Shih are both considered to be analogous to the claimed invention because they are in the same field of intravascular elastography. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Hollender to incorporate the above teachings of Shih to provide at least a catheter or guidewire. Doing so would aid in distinguishing the elastic properties of plaques and vessels (see Shih Abstract).
With regards to Claim 21, Hollender discloses wherein the repeated measurements of the flow velocity at the first location are performed periodically (performing the multi-resolution analyzing techniques repeatedly; see Hollender ¶ [0056]); and
wherein the repeated measurements of the flow velocity at the second location are performed periodically (performing the multi-resolution analyzing techniques repeatedly; see Hollender ¶ [0056]).
With regards to Claim 31, wherein the processor is configured to:
calculate a plurality of time delays across the first distribution of flow velocities and the second distribution of flow velocities (FIG. 6 illustrates the velocity distribution based on the ToF for a plurality of focal depths t along the transducer in the x-direction; see Hollender ¶ [0076]); and
average the plurality of time delays to determine the time delay used to calculate the pulse wave velocity (averaging a time-of-flight difference and/or velocity estimate of the shear wave for the first and second sets of spatially equivalent positions; see Hollender ¶ [0052]).
With regards to Claim 43, wherein the plurality of time delays comprises an individual time delay for each velocity the first distribution of flow velocities and the second distribution of flow velocities (averaging a time-of-flight difference and/or velocity estimate of the shear wave for the first and second sets of spatially equivalent positions; see Hollender ¶ [0052]; averaged ToF measurements are based on individual measurements).
With regards to Claim 71, wherein, to determine the time delay, the processor is configured to perform cross-correlation between the first distribution of flow velocities and the second distribution of flow velocities (Various techniques may be used to estimate the time delay between the two signals, including the sum-of-absolute differences, normalized cross-correlation, and phase-based methods; see Hollender ¶ [0063]).
With regards to Claim 87, wherein the time delay corresponds to a highest correlation (solving for peaks of the correlation function; see Hollender ¶ [0085]).
With regards to Claim 97, wherein the cross-correlation comprises a cross-variance (the cross-covariance is often called cross-correlation1).
With regards to Claim 101, wherein the ultrasound transducer is positioned at a tip of the intravascular catheter or guidewire (FIGS. 1a-1b of Shih clearly illustrate the imaging transducer at the tip of the IVUS device).
With regards to Claim 111, wherein the ultrasound transducer is configured to be aimed along an axis of the blood vessel (FIGS. 1a-1b of Shih clearly illustrate the imaging transducer aimed along the diametric axis of the blood vessel).
With regards to Claim 51, modified Hollender teaches of wherein the first distribution of time delays comprises a first frequency spectrum; and wherein the second distribution of time delays comprises a second frequency spectrum (various techniques may be used to estimate the time delay between the two signals, including the sum-of-absolute differences, normalized cross-correlation, and phase-based methods; see Hollender ¶ [0052]; one of ordinary skill in the art would recognize that a phase-based correlation relies on a Fourier transform, i.e. frequency binning).
While modified Hollender teaches of binning the time delays based on phase correlation, it appears that modified Hollender may be silent to flow velocity binning. However, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have further modified Hollender to provide at least provide a first and second frequency spectrum. Doing so would amount to combining prior art elements according to known methods to yield predictable results because converting the taught time delay to velocity requires the trivial task of a ratio between the corresponding time-delay and a known distance travelled (see Hollender Equation 3).
With regards to Claim 65, wherein the time delay is determined based on frequency bins of the first frequency spectrum and the second frequency spectrum (various techniques may be used to estimate the time delay between the two signals, including the sum-of-absolute differences, normalized cross-correlation, and phase-based methods; see Hollender ¶ [0052]; one of ordinary skill in the art would recognize that a phase-based correlation relies on a Fourier transform, i.e. frequency binning; and the converse of binning the velocity instead of the time delay is trivial as detailed with Claim 5),
wherein each frequency bin corresponds to a flow velocity or a range of flow velocities (converting the taught time delay to velocity requires the trivial task of a ratio between the corresponding time-delay and a known distance travelled as detailed with Claim 5; see Hollender Equation 3).
Claims 12-13 are rejected under 35 U.S.C. 103 as being unpatentable over Hollender in view of Shih as applied to claim 1 above, and further in view of Vappou et al. (“Pulse Wave Imaging for Noninvasive and Quantitative Measurement of Arterial Stiffness In Vivo,” (1 April 2010), American Journal of Hypertension, Volume 23, Issue 4, April 2010, Pages 393–398; hereinafter "Vappou").
With regards to Claim 121, modified Hollender teaches of wherein the repeated measurements of the flow velocity at the first location and the repeated measurements of a flow velocity at the second location are performed using shear wave ultrasound (shear wave generation and tracking at multiple focal depths; see Hollender ¶ [0052] & FIG. 6).
Moreover, Hollender teaches “[A]lthough embodiments according to the invention are described herein with respect to shear waves, it should be understood that multi-resolution analysis may be used to estimate other forms of tissue motion and/or displacement, including axial tissue motion” (see Hollender ¶ [0058]), however it appears that Hollender may be silent to pulsed wave Doppler.
Vappou teaches of measuring arterial stiffness, like Hollender (see Hollender ¶ [0054]), via pulsed wave velocity of a pulse wave-induced displacement of the arterial wall (see Vappou Abstract). Vappou also mentions shear modulus testing (see Vappou pg. 395, ¶ 2). In particular, Vappou teaches of achieving the measurements with using Doppler flow probes.
Modified Hollender and Vappou are both considered to be analogous to the claimed invention because they are in the same field of ultrasonic arterial stiffness quantification. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have further modified Hollender to incorporate the above teachings of Vappou to provide at least Doppler ultrasound. Doing so would aid in regional tracking of the pulse wave in arteries (see Vappou pg. 396, ¶ 3).
Claim 13 recites similar limitations and are rejected under the same rationale as Claim 12.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Chevalier (US PGPUB 20120316419); and
Harada et al. (“On-line noninvasive one-point measurements of pulse wave velocity,” (December 2002), Heart Vessels 17, 61–68 (2002).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ASHISH S. JASANI whose telephone number is (571) 272-6402. The examiner can normally be reached M-F 9:00 am - 5:00 pm (CST).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Keith Raymond can be reached on (571) 270-1790. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ASHISH S. JASANI/Examiner, Art Unit 3798
/KEITH M RAYMOND/Supervisory Patent Examiner, Art Unit 3798
1 https://en.wikipedia.org/w/index.php?title=Cross-covariance&oldid=810799832
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