DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-3, 7, 10-11, and 14 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Shulepov et al. (US 2022/0110603).
Shulepov et al. discloses an ultrasound blood vessel imaging system comprising: a 3D ultrasound probe operable to capture 3D volume data of tissue containing one or more blood vessels ([0054-0057]; [0071]; [0074]; [0191]); and a processor in communication with the 3D ultrasound probe ([0053]) configured to: receive data and convert the data to a volume of ultrasound images ([0104]; [0108]); process the ultrasound images using an image segmentation method to identify a blood vessel lumen independent of surrounding tissue and generate a segmented vessel ([0108]; [0159-0160]; [0183]); select cross-sections of the transverse ultrasound images, wherein the cross-sections include a central portion of the blood vessel lumen, generate a constructed view of the blood vessel by assembling the segmented vessel ([0097-0098]; [0100]); and display the constructed view on an electronic display (40; [0100]).
With respect to claim 2, Shulepov et al. discloses wherein the 3D ultrasound probe comprises a movable linear ultrasound array configured to sweep along a longitudinal direction to capture transverse images throughout a scan volume ([0055]; [0172]).
With respect to claim 3, Shulepov et al. discloses wherein the 3D ultrasound comprises a matrix array configured to capture volumetric ultrasound data ([0057]; [0166]; [0191]).
With respect to claim 7, Shulepov et al. discloses wherein the blood vessel is a vein, artery, arteriovenous graft, or arteriovenous fistula ([0110]; [0117]).
With respect to claim 10, Shulepov et al. discloses wherein processing the ultrasound images further comprises calculating a diameter, depth, centroid, or combination thereof of the blood vessel lumen in the volume ([0035]; [0065]; [0117]; [0130]).
With respect to claim 11, Shulepov et al. discloses wherein the constructed view is a coronal view or a sagittal view, or in a plane within about 30 degrees to the coronal plane or the sagittal plane ([0015]; [0021]; [0024]; [0026]; 120; [0104]).
With respect to claim 14, Shulepov et al. discloses wherein the constructed view comprises a simplified representation of the blood vessel lumen ([0095]; [0097]; Fig. 7).
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.
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shulepov et al. (US 2022/0110603) in view of Eggers et al. (US 2013/0225986).
Shulepov et al. discloses the subject matter substantially as claimed except for wherein the 3D volume data has a scan volume with a length from about 2 cm to about 10 cm, a width from about 2 cm to about 10 cm, and a depth from about 0 cm to about 10 cm. However, Eggers et al. teaches in the same field of endeavor a known ultrasound swept volume of tissue with a width of 5 cm, a depth of 5 cm, and a length of 15 cm ([0075]). The Examiner’s position is that a change in size/proportion is well within the skill level of one of ordinary skill in the art (MPEP 2144.04(IV)(A)). Therefore, it would have been obvious to one of ordinary skill in the art to have provided Shulepov et al. with the ultrasound volume as taught by Eggers et al. as it is a well-known volume for imaging tissue and any change size/proportion is well within the skill level of one of ordinary skill in the art (MPEP 2144.04(IV)(A)).
Claim(s) 5-6, 12, 16, and 18-21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shulepov et al. (US 2022/0110603) in view of Shimura et al. (US 2004/0087855) and Orome et al. (US 2012/0165679).
Shulepov et al. discloses the subject matter substantially as claimed except for wherein the 3D ultrasound probe includes a plurality of cannulation markings on a periphery of the 3D ultrasound probe, and wherein the processor is further configured to display a representation of at least one marking corresponding to a cannulation marking on the 3D ultrasound probe to indicate a recommended cannulation path. However, Shimura et al. teaches in the same field of endeavor wherein the processor is configured to display a representation of at least one marking corresponding to a cannulation marking on the 3D ultrasound probe to indicate a recommended cannulation path ([0189]). Therefore, it would have been obvious to one of ordinary skill in the art to have provided Shulepov et al. with the teachings of Shimura et al. in order to show the destination point of the tip of the needle superimposed on the image before the puncture is started ([0189]). Shimura et al. does not teach a plurality of cannulation markings on the probe. However, Orome et al. teaches in the same field of endeavor providing a plurality of markings on the needle guide to indicate the depth at which the needle would intercept the plane of the image ([0031]). Therefore, it would have been obvious to one of ordinary skill in the art to have provided Shulepov et al. with a plurality of markings as taught by Orome et al. in order to indicate a plurality of interception depths ([0031]).
Claim(s) 8-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shulepov et al. (US 2022/0110603) in view of Wang et al. (US 10,430,949).
Shulepov et al. discloses the subject matter substantially as claimed except for using a deep learning image segmentation model. However, Wang et al. teaches in the same field of endeavor using a deep learning model in image segmentation is well known. Therefore, it would have been obvious to one of ordinary skill in the art to have provided Shulepov et al. with a deep learning segmentation model as taught by Wang et al. as a substitution of one image segmentation model for another is well within the skill level of one of ordinary skill in the art.
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shulepov et al. (US 2022/0110603) in view of Ladak et al. (US 6,251,072).
Shulepov et al. discloses the subject matter substantially as claimed except for wherein the constructed view does not include tissue surrounding the blood vessel lumen. However, Ladak et al. teaches in the same field of endeavor it is well known for segmentation method for extracting and displaying the lumen surfaces (col. 2, lines 38-43). Therefore, it would have been obvious to one of ordinary skill in the art to have provided Shulepov et al. with extracting the segmented vessels as taught by Ladak et al. in order to display the lumen surfaces of the vessels (col. 2, lines 38-43).
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shulepov et al. (US 2022/0110603) in view of Schein et al. (US 2021/0100526).
Shulepov et al. discloses the subject matter substantially as claimed except for wherein the processor is further configured to automatically adjust a gain and/or depth of the transverse ultrasound images. However, Schein et al. teaches in the same field of endeavor automatically adjusting the gain and/or depth in order to maintain a desired imaging plane and focus of a tracked anatomical feature ([0093]). Therefore, it would have been obvious to one of ordinary skill in the art to have provided Shulepov et al. with automatically adjusting gain and/or depth as taught by Schein et al. in order to maintain a desired imaging plane and focus of a tracked anatomical feature ([0093]).
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shulepov et al. (US 2022/0110603) in view of State et al. (US 2019/0247130).
Shulepov et al. discloses the subject matter substantially as claimed except for comprising a spatial position tracking feature adapted to track a position of the 3D ultrasound probe. However, State et al. teaches in the same field of endeavor tracking the ultrasound probe in order to determine the relative locations of the ultrasound images and locate them in 3D space ([0071]; [0076]; [0189]). Therefore, it would have been obvious to one of ordinary skill in the art to have provided Shulepov et al. with the tracking feature as taught by State et al. in order to track the position and orientation of the ultrasound probe and to determine the relative locations of the ultrasound images and locate them in 3D space ([0071]; [0076]; [0189]).
Claim(s) 22-24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shulepov et al. (US 2022/0110603) in view of Shimura et al. (US 2004/0087855) and Orome et al. (US 2012/0165679) as applied to claim 18, further in view of Burkholz et al. (US 2020/0230391).
Shulepov et al. in view of Shimura et al. and Orome et al. discloses the subject matter substantially as claimed except for recommending needle diameter or length. However, Burkholz et al. teaches in the same field of endeavor recommendations may include type, size, length, or gauge of needle ([0011]; [0121]). Therefore, it would have been obvious to one of ordinary skill in the art to have provided Shulepov et al. with recommendations as taught by Burkholz et al. in order to select the appropriate needle to use ([0011]; [0121]). The Examiner notes that a change in size/proportion is well within the skill level of one of ordinary skill in the art (MPEP 2144.04(IV)(A)).
Claim(s) 25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shulepov et al. (US 2022/0110603) in view of Shimura et al. (US 2004/0087855) and Orome et al. (US 2012/0165679) as applied to claim 18, further in view of Ladak et al. (US 6,251,072).
Shulepov et al. in view of Shimura et al. and Orome et al. discloses the subject matter substantially as claimed except for wherein the constructed view does not include tissue surrounding the blood vessel lumen. However, Ladak et al. teaches in the same field of endeavor it is well known for segmentation method for extracting and displaying the lumen surfaces (col. 2, lines 38-43). Therefore, it would have been obvious to one of ordinary skill in the art to have provided Shulepov et al. with extracting the segmented vessels as taught by Ladak et al. in order to display the lumen surfaces of the vessels (col. 2, lines 38-43).
Claim(s) 26-27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shulepov et al. (US 2022/0110603) in view of Shimura et al. (US 2004/0087855) and Orome et al. (US 2012/0165679) as applied to claim 18, further in view of Chen et al. (US 2008/0027356).
Shulepov et al. in view of Shimura et al. and Orome et al. discloses the subject matter substantially as claimed except for finding centroids and generating a centerline. However, Chen et al. teaches in the same field of endeavor it is well known vessel segmentation for finding centroids and generating centerline (5. Centerline calculations; [0218-0235]; [0229]); and finding a diameter along the centerline ([0242]). Therefore, it would have been obvious to one of ordinary skill in the art to have provided Shulepov et al. with vessel segmentation as taught by Chen et al. in order to determine patient specific anatomical dimensions ([0030]).
Claim(s) 28-30 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shulepov et al. (US 2022/0110603) in view of Burkholz et al. (US 2020/0230391).
Shulepov et al. discloses an ultrasound blood vessel imaging system comprising: a 3D ultrasound probe operable to capture 3D volume data of tissue containing one or more blood vessels ([0054-0057]; [0071]; [0074]; [0191]); and a processor in communication with the 3D ultrasound probe ([0053]) configured to: receive data and convert the data to a volume of ultrasound images ([0104]; [0108]); process the ultrasound images using an image segmentation method to identify a blood vessel lumen independent of surrounding tissue and generate a segmented vessel ([0108]; [0159-0160]; [0183]); select cross-sections of the transverse ultrasound images, wherein the cross-sections include a central portion of the blood vessel lumen, generate a constructed view of the blood vessel by assembling the segmented vessel ([0097-0098]; [0100]); and display the constructed view on an electronic display (40; [0100]). Shulepov et al. discloses the subject matter substantially as claimed except for recommending needle diameter or length. However, Burkholz et al. teaches in the same field of endeavor recommendations may include type, size, length, or gauge of needle ([0011]; [0121]). Therefore, it would have been obvious to one of ordinary skill in the art to have provided Shulepov et al. with recommendations as taught by Burkholz et al. in order to select the appropriate needle to use ([0011]; [0121]). The Examiner notes that a change in size/proportion is well within the skill level of one of ordinary skill in the art (MPEP 2144.04(IV)(A)).
With respect to claims 29-30, Burkholz et al. discloses a second trajectory ([0076]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PETER LUONG whose telephone number is (571)270-1609. The examiner can normally be reached M-F 9-6.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anhtuan T Nguyen can be reached at (571)272-4963. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PETER LUONG/ Primary Examiner, Art Unit 3797
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