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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 05/27/2026 has been considered by the examiner.
Specification
The abstract of the disclosure is objected to because the abstract filed 08/19/2025 does not pertain to the claimed invention. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Claim Rejections - 35 USC § 103
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.
Claims 1, 4, 12-14, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Yen et al. (US 20220022848 A1, published January 27, 2022 with a priority date of July 23, 2020) in view of Dala-Krishna (US 20080312536 A1, published December 18, 2008) and Kim (US 20110144497 A1, published June 16, 2011), hereinafter referred to as Yen, Dala, and Kim, respectively.
Regarding claim 1, and similarly claim 4, Yen teaches a method, comprising:
acquiring multiple two-dimensional (2D) ultrasound slices using a probe (Fig. 2, beamformed RF signal 201; see para. 0066 – “For example, in an embodiment, programming instructions may be provided to generate B-mode image frames and corresponding RF matrices based on a reflected and received ultrasound signal, spatial filters and corresponding filtered RF matrices, and final improved coherence estimation image frames based on the filtered RF matrices.”);
applying a Laplace transform to each of the multiple 2D ultrasound slices, to produce respective 2D Laplace-transformed slices (Fig. 2, 2D FFT 202; see para. 0067 – “In other embodiments, the frequency transform may be a…Laplace transform…”);
suppressing noise in the 2D Laplace-transformed slices (Fig. 2, suppressing noise via filters 203; see para. 0068 – “The UPS 110 (see FIG. 1) may apply multiple spatial filters 203 a-n (where n is the total number of spatial filters for a given embodiment) to the k-space representation of the RF signal to generate k-space representations of multiple filtered RF signals.”);
applying an inverse Laplace transform to the inverse 3D image, to produce a 3D noise-suppressed ultrasound image (Fig. 2, 2D inverse FFT 204; see para. 0071 – “In other embodiments, the inverse frequency transform may be an …inverse Laplace transform…3D inverse frequency transforms such as 3D inverse fast Fourier transform, and 3D inverse discrete Fourier transform.”); and
displaying the 3D noise-suppressed ultrasound image to a user (Fig. 2; see para. 0078 – “The coherence coefficients 206, each corresponding to a pixel of an ultrasound image, are used to generate a coherence estimation ultrasound image based on coherence estimation 207.”).
Yen teaches acquiring ultrasound images via a probe (see para. 0066 – “For example, in an embodiment, programming instructions may be provided to generate B-mode image frames and corresponding RF matrices based on a reflected and received ultrasound signal…”), and acquiring ultrasound images via a catheter is known in the art, but does not explicitly teach acquiring multiple two-dimensional (2D) ultrasound slices using an ultrasound catheter.
Whereas, Dala, in an analogous field of endeavor, teaches acquiring multiple two-dimensional (2D) ultrasound slices using an ultrasound catheter (Fig. 3, ultrasound catheter 1; see para. 0121 – “In operation, the system processor can control the processes of rotating the phased array transducer (via commands to the step motor controller) and generating ultrasound images (via commands to the beam former circuits) so that ultrasound images are obtained when the transducer array is stopped at a particular rotational orientation (versus during movement).”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified acquiring ultrasound images, as disclosed in Yen, by acquiring ultrasound images via a catheter, as disclosed in Dala. One of ordinary skill in the art would have been motivated to make this modification in order to scan the heart and/or obtain sufficient images through a variety of viewing angles in order to generate three-dimensional ultrasound images of the heart while reducing the workload of the clinician, as taught in Dala (see para. 0050).
Yen in view of Dala teaches suppressing noise in the 2D Laplace-transformed slices, and Yen teaches performing 3D inverse transformation to transformed filtered slices (Fig. 2, 2D inverse FFT 204; see para. 0071 – “In other embodiments, the inverse frequency transform may be an …inverse Laplace transform…3D inverse frequency transforms such as 3D inverse fast Fourier transform, and 3D inverse discrete Fourier transform.”), but does not explicitly teach combining the noise-suppressed transformed slices into 3D data, then inverse transforming the 3D data to display a 3D image.
Whereas, Kim, teaches combining the noise-suppressed transformed slices into 3D data, then inverse transforming the 3D data to display a 3D image (Fig. 4, combining filtered transformed 2D slices (stage I) into 3D data (stage II), then inverse transforming the 3D data (3D IFFT) into a 3D image (stage III); see para. 0047 – “Between stages II and III, the three-dimensional ultrasound image is reconstructed by calculating the three-dimensional inverse fast Fourier transformation of the three-dimensional image data as described above with respect to step S15. The reconstructed three-dimensional ultrasound image is illustrated in stage III.”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified suppressing noise in the 2D Laplace-transformed slices, as disclosed in Yen in view of Dala, by combining the noise-suppressed transformed slices into 3D data, then inverse transforming the 3D data to display a 3D image, as disclosed in Kim. One of ordinary skill in the art would have been motivated to make this modification in order to obtain ultrasonic 3D images having a high resolution, as taught in Kim (see para. 0008).
Furthermore, regarding claims 12 and 20, Dala further teaches wherein the ultrasound catheter comprises a one-dimensional (1D) ultrasound array (Fig. 3; see para. 0051 – “A rotational drive motor 25 at the proximal end of the catheter, such as in the handle assembly 2, provides a rotational force (e.g., a torque or tension on a wire) to rotate the linear phased array transducer 31 [1D ultrasound array] about its long axis.”).
Furthermore, regarding claim 13, Dala further teaches wherein acquiring multiple two-dimensional (2D) ultrasound slices using an ultrasound catheter comprises rotating the 1D ultrasound array (Fig. 3; see para. 0051 – “A rotational drive motor 25 at the proximal end of the catheter, such as in the handle assembly 2, provides a rotational force (e.g., a torque or tension on a wire) to rotate the linear phased array transducer 31 [1D ultrasound array] about its long axis.”).
Furthermore, regarding claim 14, Dala further teaches generating a rotating fan comprising the multiple 2D slices (Fig. 3; see para. 0121 – “In operation, the system processor can control the processes of rotating the phased array transducer (via commands to the step motor controller) and generating ultrasound images (via commands to the beam former circuits) so that ultrasound images are obtained when the transducer array is stopped at a particular rotational orientation [rotating fan of multiple 2D ultrasound slices] (versus during movement).”).
The motivation for claims 12-14 and 20 was shown previously in claims 1 and 4.
Claims 2 and 5 are rejected under 35 U.S.C. 103 as being unpatentable over Yen in view of Dala and Kim, as applied to claims 1 and 4 above, and in further view of Hossack et al. (US 6042545 A, published March 28, 2000), hereinafter referred to as Hossack.
Regarding claims 2 and 5, Yen in view of Dala and Kim teaches all of the elements disclosed in claim 1 and 4 above.
Yen in view of Dala and Kim teaches filtering transformed slices, and applying low pass filtering to ultrasound data is known in the art, but does not explicitly teach applying low-pass filtering to the transformed slices.
Whereas, Hossack, in an analogous field of endeavor, teaches wherein suppressing the noise in the 2D Laplace-transformed slices comprises applying low-pass filtering to the 2D Laplace- transformed slices (see col. 7, lines 18-22 – “This process requires first finding a low pass filtered form of the original image in the transform domain. This filtering operation may be performed efficiently in the transform domain.”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified applying filtering to Laplace transformed slices, as disclosed in Yen in view of Dala and Kim, by applying low pass filtering to transformed slices, as disclosed in Hossack. One of ordinary skill in the art would have been motivated to make this modification in order to output contrast enhanced data, as taught in Hossack (see col. 7, lines 8-15).
Claims 3 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Yen in view of Dala and Kim, as applied to claim 1 and 4 above, and in further view of Lichtenstein (US 20100191101 A1, published July 29, 2010), hereinafter referred to as Lichtenstein.
Regarding claims 3 and 6, Yen in view of Dala and Kim teaches all of the elements disclosed in claim 1 and 4 above.
Yen in view of Dala and Kim teaches combining the noise-suppressed Laplace-transformed slices into the inverse 3D image, and tracking the location of the catheter via a location sensor is known in the art, but does not explicitly teach performing registration among the multiple acquired ultrasound slices using signals from a location sensor of the catheter to combine the slices based on the registration.
Whereas, Lichtenstein, in an analogous field of endeavor, teaches performing registration among the multiple acquired ultrasound slices using signals from a location sensor of the catheter; and combining the slices based on the registration (Fig. 1-2; see para. 0026 – “The coordinate readings provided by position sensor 32 [of catheter 28] are used in registering the ultrasound images captured at different positions of the catheter in order to reconstruct a full 3D image.”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified combining the noise-suppressed Laplace-transformed slices into the inverse 3D image, as disclosed in Yen in view of Dala and Kim, by performing registration among the multiple acquired ultrasound slices using signals from a location sensor of the catheter to combine the slices based on the registration, as disclosed in Lichtenstein. One of ordinary skill in the art would have been motivated to make this modification in order to accuracy reconstruct a full 3D image, as taught in Lichtenstein (see para. 0026).
Claims 7-11 and 15-19 are rejected under 35 U.S.C. 103 as being unpatentable over Yen in view of Dala and Kim, as applied to claims 1 and 4 above, and in further view of Merritt (US 20200069264 A1, published March 5, 2020), hereinafter referred to as Merritt.
Regarding claims 7 and 15, Yen in view of Dala and Kim teaches all of the elements disclosed in claim 1 and 4 above.
Yen in view of Dala and Kim teaches the ultrasound catheter is an intracardiac device (Dala: see para. 0050 – “The embodiments include a dynamic ultrasound imaging catheter with a control mechanism for rotating the phased array ultrasound transducer within the catheter body when positioned within the heart…”), and using an intravascular ultrasound (IVUS) catheter to examine a blood vessel is known in the art, but does not explicitly teach wherein the ultrasound catheter comprises an intravascular device.
Whereas, Merritt, in an analogous field of endeavor, teaches wherein the ultrasound catheter comprises an intravascular device (Fig. 4; see 0052 – “It is understood that one or more of the instruments 130, 132, 150, 152 can a guide wire, a guide catheter, a catheter, or any other suitable intraluminal device…One, two, three, four or more sensors are coupled to the distal portion of the flexible elongate member and is configured obtain any suitable data associated with the body lumen while positioned within the body lumen. The data can include one or more of…images (including images obtained using ultrasound (e.g., IVUS)…”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the catheter, as disclosed in Yen in view of Dala and Kim, by having an intravascular device as the catheter, as disclosed in Merritt. One of ordinary skill in the art would have been motivated to make this modification in order to examine a blood vessel, as taught in Merritt (see para. 0052).
Furthermore, regarding claims 8 and 16, Merritt further teaches wherein the ultrasound catheter comprises a transesophageal ultrasound device (Fig. 4; see para. 0052 – “It is understood that one or more of the instruments 130, 132, 150, 152 can a guide wire, a guide catheter, a catheter, or any other suitable intraluminal device…One or more of the instruments 130, 132, 150, 152 can be an intracardiac (ICE) echocardiography catheter and/or a transesophageal echocardiography (TEE) probe.” Where TEE probes are known in the art).
One of ordinary skill in the art would have been motivated to make this modification in order to examine any number of anatomical locations and tissue types, including the heart, liver, kidneys, and lungs, as taught in Merritt (see para. 0052).
Furthermore, regarding claims 9 and 17, Merritt further teaches wherein the ultrasound catheter comprises an imaging probe used to image a lung (Fig. 4; see para. 0052 – “It is understood that one or more of the instruments 130, 132, 150, 152 can a guide wire, a guide catheter, a catheter, or any other suitable intraluminal device…For example, the instruments 130, 132, 150, 152 may be used to examine any number of anatomical locations and tissue types, including without limitation, organs including the… lungs;…”).
Furthermore, regarding claims 10 and 18, Merritt further teaches wherein the ultrasound catheter comprises an imaging probe used to image a liver (Fig. 4; see para. 0052 – “It is understood that one or more of the instruments 130, 132, 150, 152 can a guide wire, a guide catheter, a catheter, or any other suitable intraluminal device…For example, the instruments 130, 132, 150, 152 may be used to examine any number of anatomical locations and tissue types, including without limitation, organs including the liver…”).
Furthermore, regarding claims 11 and 19, Merritt further teaches wherein the ultrasound catheter comprises an imaging probe used to image a kidney (Fig. 4; see para. 0052 – “It is understood that one or more of the instruments 130, 132, 150, 152 can a guide wire, a guide catheter, a catheter, or any other suitable intraluminal device…For example, the instruments 130, 132, 150, 152 may be used to examine any number of anatomical locations and tissue types, including without limitation, organs including the… kidneys,…”).
The motivation for claims 9-11 and 17-19 was shown previously in claims 8 and 16.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Hennersperger et al. (US 20210361258 A1, published November 25, 2021 with a priority date of August 31, 2018) discloses a catheter-based ultrasound imaging system configured to provide a full circumferential 360-degree view around an intra-vascular/intra-cardiac imaging-catheter-head by generating a three-dimensional view of the tissue surrounding the imaging-head over time.
Lupotti et al. (US 20170354395 A1, published December 14, 2017) discloses a plurality of two-dimensional image slices can be obtained, and these image slices can then be assembled into a three-dimensional volumetric image.
Rahn (US 20060262139 A1, published November 23, 2006) discloses records individual two-dimensional images of the heart using a rotating ultrasound probe in order to collect data for a three-dimensional reconstruction image.
Altmann et al. (US 20060241445 A1, published October 26, 2006) discloses a three-dimensional (3-D) model of the anatomical structure is constructed, based on the contours-of-interest and on the measured location and orientation coordinates.
Vignon et al. (US 20220096054 A1, published March 31, 2022 with a priority date of February 22, 2019) discloses the probe may be in the form of a catheter, an intravascular ultrasound (IVUS) catheter, an intracardiac echocardiography (ICE) catheter, a transesophageal echocardiography (TEE) probe, a transthoracic echocardiography (TTE) probe, an endo-cavity probe; and the object may include any anatomy (e.g., lung, blood vessel, tissues, heart, kidney, and/or liver) of a patient that is suitable for ultrasound imaging examination.
Jiang et al. (US 20210090228 A1, published March 25, 2021) discloses performing a plurality of low-pass filtering operations on the original image based on the plurality of filtering kernels; and generating the target image by performing a reconstruction on at least one of the plurality of enhanced images and the original image via a Laplace transform reconstruction.
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/N.C./Examiner, Art Unit 3798