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 statements (IDS) submitted on 02/12/2026, 05/21/2026, and 08/20/2026 were filed in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Claim Objections
Claim 4 is objected to because of the following informalities:
Regarding claim 4, as written it reads “wherein the first flow rate value and the second flow rate value are detected distal an insertion site of the vascular access device”. However, the examiner believes that “first flow rate value” corresponds to “first fluid flow rate value” and “second flow rate value” corresponds to “second fluid flow rate value” as recited in claim 1. The examiner recommends clarifying whether this assumption is correct. If correct, the examiner would recommend updating the claim language to ensure proper antecedent basis.
Appropriate correction is required.
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.
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Claims 1-4, 8, and 10-11 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3-5, 8, 12, and 15 of U.S. Patent No. 12,514,533 B2.
Although the claims at issue are not identical, they are not patentably distinct from each other because they both relate to an ultrasound imaging system which utilizes a doppler array to determine blood flow rate resulting from the insertion of a vascular access device.
The following chart is a comparison of the claim language.
19/440,091
US 12,514,533 B2
1. An ultrasound imaging system configured to assess the impact of placement of a vascular access device on fluid flow through a target vessel, comprising: an ultrasound probe, comprising: an ultrasound array configured to capture one or more ultrasound images of the target vessel; and a Doppler array configured to detect the fluid flow through a region of interest of the target vessel; and a console in communication with each of the ultrasound array and the Doppler array, the console configured to perform operations comprising: displaying an image of the target vessel within a target area on a display of the console; automatically selecting a portion of the target vessel as a region of interest along the target vessel via logic operations of the console using anatomical targets in proximity to the target vessel within the target area; obtaining first fluid flow rate data from the Doppler array indicating a first fluid flow rate value through the region of interest prior to placement of the vascular access device within the target vessel; imaging the target vessel after placement of the vascular access device within the target vessel; obtaining second fluid flow rate data from the doppler array indicating a second fluid flow rate value through the region of interest after placement of the vascular access device within the target vessel; and detecting that fluid flow through the target vessel has been compromised based on results of comparing the second fluid flow rate value with a flow rate value threshold.
1. An ultrasound imaging system, comprising: an ultrasound probe, comprising: an ultrasound array configured to acquire an ultrasound image of a target area of a patient, and a doppler array configured to determine a blood flow rate through a region of interest within the ultrasound image, wherein: the region of interest includes a target blood vessel, the target blood vessel includes an insertion site configured for insertion of a vascular access device therethrough, and the blood flow rate through the region of interest includes a blood flow rate through the target blood vessel; and a console coupled with the ultrasound array and the doppler array, the console including one or more processors and a memory having logic stored thereon that, when executed by the one or more processors, performs operations, including: acquiring the ultrasound image of the target area; storing data composed of multiple ultrasound images acquired during operation of the ultrasound imaging system, wherein each ultrasound image is paired with a corresponding region of interest selected by a clinician to define a training set of region of interest data; performing operations on the training set of region of interest data to define a suggested region of interest within the acquired ultrasound image; identifying the region of interest within the ultrasound image based on the training set of region of interest data; determining the blood flow rate via the doppler array through the target blood vessel at a location along the target blood vessel upstream of the insertion site; and determining the blood flow rate via the doppler array through the target blood vessel at the location along the target blood vessel downstream of the insertion site.
2. The ultrasound imaging system according to claim 1, wherein the console is configured to determine a total cross sectional area of the target vessel using one or more ultrasound images.
5. The system according to claim 1, wherein the operations further include determining a cross-sectional area of the target blood vessel from the ultrasound image.
3. The ultrasound imaging system according to claim 2, wherein the impact of the vascular access device on fluid flow through the target vessel is expressed as a percent of the total cross sectional area of the target vessel.
8. The system according to claim 7, wherein the operations further include determining a percentage of a cross-sectional area of the target blood vessel occupied by the cross-sectional area of the vascular access device.
4. The ultrasound imaging system according to claim 1, wherein the first flow rate value and the second flow rate value are detected distal an insertion site of the vascular access device.
15. The system according to claim 6, wherein the operations further include determining the blood flow rate through the target blood vessel with the vascular access device present within the target blood vessel at the location along the target blood vessel downstream of the vascular access device to define a downstream blood flow rate.
8. The ultrasound imaging system according to claim 1, wherein automatically selecting a portion of the target vessel as the region of interest includes using historical data from previously acquired ultrasound images of the target area to identify the region of interest.
4. The system according to claim 1, wherein identifying the region of interest includes automatically identifying the region of interest based on the training set of region of interest data.
12. The system according to claim 10, wherein the operations further include: storing data composed of multiple corresponding combinations of the cross-sectional area of the target blood vessel, the cross-sectional area of the vascular access device, the first blood flow rate, and the second blood flow rate as acquired during operation of the ultrasound imaging system to define a training set of historical blood flow data; and performing operations on the training set of historical blood flow data to predict the second blood flow rate with the vascular access device present within the target blood vessel based on a determined first blood flow rate with the vascular access device absent from the target blood vessel.
10. The ultrasound imaging system according to claim 1, wherein the console is configured to perform further operations comprising: generating a flow rate data icon overlay including the first fluid flow rate data, and matching coordinates of the image of the target vessel with coordinates of the flow rate data icon overlay to locate the flow rate data icon overlay at the region of interest.
3. The system according to claim 1, wherein the operations further include overlaying on the ultrasound image an indication of the suggested region of interest.
11. The ultrasound imaging system according to claim 1, wherein the console is configured to perform further operations comprising: determining a total cross-sectional area value of the target vessel from the image of the target vessel, and determining a vascular access device occupancy percentage based on the total cross-sectional area value and a cross-sectional area value of the vascular access device.
8. The system according to claim 7, wherein the operations further include determining a percentage of a cross-sectional area of the target blood vessel occupied by the cross-sectional area of the vascular access device.
Allowable Subject Matter
The following is a statement of reasons for the indication of allowable subject matter:
During the examiner’s search the following prior art references were found: US 2015/0209510 “Burkholz”; Mason et al. US 2020/0069929 A1 “Mason”; Southard et al. US 2018/0228465 A1 “Southard”; Lyon et al. US 2016/0000367 A1 “Lyon”; Weitzel et al. US 2008/0108930 A1 “Weitzel”; Southard et al. US 2018/0015256 A1 “Southard-2”; Shiran et al. US 2021/0045716 A1 “Shiran”.
Burkholz is pertinent to the applicant’s disclosure because it discloses “As shown in FIG. 8, the system 10e is provided with an external ultrasound monitor 64 comprising a control module 66 and attached to a wand 68 or scanner. The control module 66 may include an integrated display. The ultrasound monitor 64 may be used to obtain an initial image of the patient's vascular anatomy prior to performing the invasive procedure. The ultrasound image obtained may be helpful for automatically differentiating between arteries and veins, may help to determine which vein is most suitable for a particular vascular access, and may assist in selecting a correct catheter size and length for a particular vein. The image of the injection site captured by the digital camera 12 may be captured simultaneously with obtaining an ultrasound scan to facilitate lining up the two images” [0088]; “Once the images are obtained and a desirable invasive access site and vein is determined, this location information is transmitted to the wearable electronic device 18 and used in conjunction with the anatomic positioning information obtained by processing the captured image to determine the location for the virtual trace 62” [0089]; “After the insertion is performed, the system 10e may be configured to obtain a real-time ultrasound image to confirm correct placement of the needle of the vascular access device 60 in the vein. Similarly, the system 10e could record a time and date stamp for the insertion and include such information in the patient's record. The system 10e may also record the location of the vascular insertion. This information may be used to prevent repeat insertion in the same area of the patient's body” [0092].
However, Burkholz does not teach “a Doppler array configured to detect the fluid flow through a region of interest of the target vessel”; “automatically selecting a portion of the target vessel as a region of interest along the target vessel via logic operations of the console using anatomical targets in proximity to the target vessel within the target area”; “obtaining first fluid flow rate data from the Doppler array indicating a first fluid flow rate value through the region of interest prior to placement of the vascular access device within the target vessel”; […] “obtaining second fluid flow rate data from the doppler array indicating a second fluid flow rate value through the region of interest after placement of the vascular access device within the target vessel”; or“ detecting that fluid flow through the target vessel has been compromised based on results of comparing the second fluid flow rate value with a flow rate value threshold” as required by claim 1.
Mason is pertinent to the applicant’s disclosure because it discloses “Using the VADs 1101a, measurements are optionally made at the same location and/or orientation on the internal structure at different times. For example, the measurement device 1159a may be moved between measurements and/or may be used to measure another location and/or another subject. […] Repeating measurements of the same internal structure over time optionally facilitates detecting changes of the structure and/or its functioning (for example changes in the state of a blood vessel and/or blood flow). For example, an external ultrasound (US) probe may be used to measure changes blood velocity over time at a particular location. Measured changes may be processed for example to give an estimate of a degree of stenosis of the vessel” [0269]; “In some embodiments, hemodynamics of a vessel (for example an AV fistula) will be characterized based on measured blood velocity. For example, a measuring device may use a U/S Doppler technology. Optionally measurement 1476 is enhanced by accurate placement 1472 of the measuring device via markers. For example, a marker may be embedded in a VAD implant” [0277]; “Manipulated data to display important information. For example, trends of changes in blood velocity over time may be displayed. The controller optionally incorporates a notification processor that communicates alerts when velocity is below a pre-set threshold” [0185].
However, Mason does not “assess the impact of the placement of a vascular access device” and does not teach “automatically selecting a portion of the target vessel as a region of interest along the target vessel via logic operations of the console using anatomical targets in proximity to the target vessel within the target area” as required by claim 1.
Southard is pertinent to the applicant’s disclosure because it discloses “ In one embodiment, an ultrasound imaging system for assisting with placement of the medical device comprises a console, a probe for producing an image of a target location, and a processor” [Abstract]; “ FIG. 3 shows use of the system 10 in accessing a vessel 86 with a needle 84 in preparation for inserting a catheter into the vessel. The probe 40, equipped with the head-covering cap 50 and attached needle guide 60, is placed against the skin so as to ultrasonically image a slice of internal body tissue of the patient below the surface of the skin 82. Indeed, a target location 88 of the vessel 86 imaged by the probe 40 is disposed a substantially vertical depth x below the end of the probe, corresponding to the skin surface 82” [0028}.
However, Southard does not teach “automatically selecting a portion of the target vessel as a region of interest along the target vessel via logic operations of the console using anatomical targets in proximity to the target vessel within the target area”; “obtaining first fluid flow rate data from the Doppler array indicating a first fluid flow rate value through the region of interest prior to placement of the vascular access device within the target vessel”; “obtaining second fluid flow rate data from the doppler array indicating a second fluid flow rate value through the region of interest after placement of the vascular access device within the target vessel” or “detecting that fluid flow through the target vessel has been compromised based on results of comparing the second fluid flow rate value with a flow rate value threshold” as required by claim 1.
Lyon is pertinent to the applicant’s disclosure because it discloses “The preferred component would be an ultrasound transducer configured such that both B-mode imaging and Doppler modalities are combined into one probe for a dedicated ICP assessment device. Such probes can interface with handheld computers, so the operator can scan a patient in the field using battery power and minimal physical footprint” [0100]; “A physical modification may be done by mounting two ultrasound modalities together, for example a B-mode linear array of ultrasound transducers and a Doppler pulse wave piezoelectric crystal aligned so that the combined probe can target the same area of interest” [0102].
However, Lyon makes no mention of using an ultrasound probe for assessing the impact of placement of a vascular access device and Lyon does not teach “automatically selecting a portion of the target vessel as a region of interest along the target vessel via logic operations of the console using anatomical targets in proximity to the target vessel within the target area”; “obtaining first fluid flow rate data from the Doppler array indicating a first fluid flow rate value through the region of interest prior to placement of the vascular access device within the target vessel”; “obtaining second fluid flow rate data from the doppler array indicating a second fluid flow rate value through the region of interest after placement of the vascular access device within the target vessel” or “detecting that fluid flow through the target vessel has been compromised based on results of comparing the second fluid flow rate value with a flow rate value threshold” as required by claim 1.
Weitzel is pertinent to the applicant’s disclosure because it discloses “ FIG. 6 illustrates an embodiment of the present invention suitable for use in single needle dialysis as described in Van Holder R, Hoenich N, Ringoir S, "Adequacy studies of fistula single-needle dialysis", Am J Kidney Dis, 10(6); December 1987; 417-426. In this embodiment, two sensors 47, 49 are disposed on or integrated with an access needle 36. The sensors 47, 49 may include a combination of sensing elements, such as more than one pressure sensor used to detect ? P which can be related to volume flow or velocity, and may also be ultrasound, Doppler, electromagnetic, HALL effect, chemical sensor, other physical property signal such as viscosity or mass flux sensor, that can be related to flow, velocity, mechanical property or other parameter to be measured according to the present invention” [0064]; “The access has a blood flow rate (QA) dependent on numerous factors including systemic blood pressure and central venous pressure (reflecting pressure gradient pre and post access), access geometry (and thereby resistance), and blood viscosity […] The flow through the graft or fistula downstream (QD) from the arterial needle will decrease during dialysis as a function of the blood flowing through the dialysis circuit at a blood pump flow rate (QB). To the extent that the net flow through the system does not change during dialysis, this flow rate through the portion of the access between the dialysis needles during dialysis (QD) will follow the relationship QD=QA-QB” [0010].
However, Weitzel does not require imaging before and after placement of the dialysis needles in a patient’s blood vessel and does not teach “automatically selecting a portion of the target vessel as a region of interest along the target vessel via logic operations of the console using anatomical targets in proximity to the target vessel within the target area”; “obtaining first fluid flow rate data from the Doppler array indicating a first fluid flow rate value through the region of interest prior to placement of the vascular access device within the target vessel”; “obtaining second fluid flow rate data from the doppler array indicating a second fluid flow rate value through the region of interest after placement of the vascular access device within the target vessel” or “detecting that fluid flow through the target vessel has been compromised based on results of comparing the second fluid flow rate value with a flow rate value threshold” as required by claim 1.
Southard-2 is pertinent to the applicant’s disclosure because it discloses “Systems and methods for assisting the placement of a catheter within a vessel of a patient via an ultrasound imaging system are disclosed. The systems and methods described herein relate to an automatic size comparison tool to enable a clinician to determine, prior to insertion of the catheter, whether a particularly sized catheter will fit within a designated vessel of the patient without violating a user-defined rule setting a maximum percentage of the vessel that may be occupied by the catheter. This in turn ensures that the catheter is properly sized for the vessel in which it is placed, according to user-defined preferences” [Abstract]; “
However, Southard-2 does not require imaging before and after placement of the catheter (i.e. vascular access device) in a patient’s blood vessel and does not teach “automatically selecting a portion of the target vessel as a region of interest along the target vessel via logic operations of the console using anatomical targets in proximity to the target vessel within the target area”; “obtaining first fluid flow rate data from the Doppler array indicating a first fluid flow rate value through the region of interest prior to placement of the vascular access device within the target vessel”; “obtaining second fluid flow rate data from the doppler array indicating a second fluid flow rate value through the region of interest after placement of the vascular access device within the target vessel” or “detecting that fluid flow through the target vessel has been compromised based on results of comparing the second fluid flow rate value with a flow rate value threshold” as required by claim 1.
Shiran is pertinent to the applicant’s disclosure because it discloses “Still referring to FIG. 1, the training engine 160 may comprise suitable logic, circuitry, interfaces and/or code that may be operable to train the neurons of the deep neural network(s) of the artificial intelligence segmentation module 140. For example, the artificial intelligence segmentation module 140 may be trained to automatically identify and segment biological and/or artificial structures provided in an ultrasound scan plane. […] As an example, the artificial intelligence segmentation module 140 may be trained by the training engine 160 with ultrasound images of particular biological and/or artificial structures to train the artificial intelligence segmentation module 140 with respect to the characteristics of the particular structure, such as the appearance of structure edges, the appearance of structure shapes based on the edges, the positions of the shapes relative to landmarks in the ultrasound image data, and the like. In an exemplary embodiment, the structures may include a brachial plexus nerve bundle, the axillary artery, beveled regions on anesthetic needles, and/or any suitable organ, nerve, vessel, tissue, needle, implantable device, or the like” [0043].
However, Shiran makes no mention of using a vascular access device and furthermore does not teach “automatically selecting a portion of the target vessel as a region of interest along the target vessel via logic operations of the console using anatomical targets in proximity to the target vessel within the target area” as required by claim 1.
Thus, the prior art references of Burkholz; Mason; Southard; Lyon; Weitzel; Southard-2 and Shiran, both individually and in combination do not teach each and every limitation of claim 1.
Therefore, claim 1 and its corresponding dependent claims (i.e. claims 2-11) as best understood by the examiner, appear to contain allowable subject matter.
As allowable subject matter has been indicated, applicant's reply must either comply with all formal requirements or specifically traverse each requirement not complied with. See 37 CFR 1.111(b) and MPEP § 707.07(a).
Conclusion
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/KAITLYN E SEBASTIAN/Examiner, Art Unit 3797
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