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 § 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 2, 5, 6, 12, 14, 17, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Halmann (US 20160000399) and further in view of Nields (US 20030073895) and Yan (US 20180132944).
Regarding claims 2 and 14, Halmann discloses a method for providing guidance for operation of a biopsy needle (Abstract – “A method and apparatus of ultrasound guidance for interventional procedures involving a needle”, [0002] – “guide procedures such as positioning a biopsy needle”), the method comprising: [claim 2]
a system ([0009] – “The apparatus includes an ultrasound imaging system”) comprising: [claim 14]
an ultrasound probe ([0009] – “The apparatus includes an ultrasound imaging system including a processor, a probe, and a display device”); [claim 14]
a display ([0009] – “The apparatus includes an ultrasound imaging system including a processor, a probe, and a display device”); [claim 14]
at least one processor operatively connected to the display and the ultrasound probe ([0009] – “The apparatus includes an ultrasound imaging system including a processor, a probe, and a display device”, Fig. 1); and [claim 14]
memory, operatively connected to the at least one processor, storing instructions that when executed by the at least one processor perform a set of operations comprising ([0026] – “The processor 116 may control the transmit beamformer 101, the transmitter 102 and, therefore, the ultrasound beams emitted by the transducer elements 104 in the probe 106. The processor 116 may also process the ultrasound data into images for display on a display device 118”, [0027] – “A memory (not shown) may be included”, the method steps of Fig. 4 and Fig. 6 are also performed by the processor therefore it would be obvious to have the instructions for the method steps stored in the memory): [claim 14]
based on the determined needle properties, determining a deflection probability for a post […insertion] tip location of the biopsy needle ([0040] – “The processor 116 may also use additional factors when calculating the risk of bending such as a gauge of the needle, a stiffness of the needle 90 (which may be related to the gauge of the needle 90)”);
generating an ultrasound image from an ultrasound probe of an interior of a patient having at least a portion of the biopsy needle disposed therein ([0009] – “control the ultrasound imaging system to acquire ultrasound data from a region of interest with the probe”, [0049] – “The screenshot 650 includes an ultrasound image 652, a representation of a needle 654…representation of the needle 654 may be based on ultrasound data”);
identifying the at least a portion of the biopsy needle within the generated ultrasound image ([0049] – “The screenshot 650 includes an ultrasound image 652, a representation of a needle 654…representation of the needle 654 may be based on ultrasound data”); and
based on the identification of the at least a portion of the biopsy needle and the determined deflection probability for the post […insertion] tip location of the biopsy needle, displaying a deflection probability indicator on the ultrasound image, wherein the deflection probability indicator indicates a range for the post […insertion] tip location based on the determined deflection probability (Figs. 8-9, [0051] – “The expected target region 682 represents an area within the ultrasound image 680 where the needle is expected based on the calculated risk of bending”).
Conversely Halmann does not teach displaying a user interface for selecting a type of biopsy needle of the biopsy needle to be used for a biopsy procedure;
receiving as input in the user interface, the input indicating the type of biopsy needle;
based on the input indicating the type of biopsy needle, determining needle properties for the biopsy needle, wherein the needle properties include at least one of a needle length, a needle gauge, a needle wall thickness, a needle material composition, a needle tip geometry, and a needle firing mechanism property;
a post-fire tip location.
However Nields discloses displaying a user interface for selecting a type of biopsy needle of the biopsy needle to be used for a biopsy procedure (Figs. 16-20 show a user interface with a select needle button, [0088] – “a select needle button in the user input area”);
receiving as input in the user interface, the input indicating the type of biopsy needle ([0088] – “Such information can be entered by using the select needle button”);
based on the input indicating the type of biopsy needle, determining needle properties for the biopsy needle, wherein the needle properties include at least one of a needle length, a needle gauge, a needle wall thickness, a needle material composition, a needle tip geometry, and a needle firing mechanism property ([0088] – “a select needle button in the user input area. It will be appreciated that different biopsy needles have different dimensions which need to be accounted for in targeting the location of interest for sampling. Such information can be entered by using the select needle button”, a needle length, a needle gauge, and a needle wall thickness are all dimensions of a needle);
The disclosure of Nields is an analogous art considering it is in the field of using a user interface to provide guidance for needle biopsy procedures.
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 method and system of Halmann to incorporate the input for selecting a needle to indicate needle properties of Nields to achieve the same results. One would have motivation to combine because it would prevent the user from having to manually enter the dimensions of the needle and the dimensions “need to be accounted for in targeting the location of interest for sampling” (Nields – [0019]).
Conversely Halmann and Nields do not teach a post-fire tip location.
However Yan discloses a post-fire tip location (Fig. 6, [0053] – “the (un-fired) needle tip is detected and the throw is added to estimate the location of the biopsy core if the needle were fired at that moment. Feedback is provided on whether the needle is positioned correctly to sample the target”).
The disclosure of Yan is an analogous art considering it is in the field of using a user interface providing guidance for needle biopsy procedures.
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 method and system of Halmann to incorporate the post-fire tip location of Yan to achieve the same results. One would have motivation to combine because it would provide guidance for biopsy procedures requiring a needle gun.
Regarding claims 5 and 17, Halmann, Nields, and Yan disclose all the elements of the claimed invention as cited in claims 2 and 14.
Conversely Halmann does not teach wherein the determining needle properties for the biopsy needle include querying a database containing the needle properties based on the input received from the user interface.
However Nields discloses wherein the determining needle properties for the biopsy needle include querying a database containing the needle properties based on the input received from the user interface ([0088] – “It will be appreciated that different biopsy needles have different dimensions which need to be accounted for in targeting the location of interest for sampling. Such information can be entered by using the select needle button”, therefore the dimensions are selected by selected by selecting the needle and therefore it can be interpreted the dimensions are queried from a database that contains the dimensions associated with each needle option).
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 method and system of Halmann to incorporate the input for selecting a needle to indicate needle properties of Nields to achieve the same results. One would have motivation to combine because it would prevent the user from having to manually enter the exact dimensions of the needle and the dimensions “need to be accounted for in targeting the location of interest for sampling” (Nields – [0019]).
Regarding claim 6, Halmann, Nields, and Yan disclose all the elements of the claimed invention as cited in claim 2.
Halmann further discloses wherein the deflection probability indicator is one of an ellipse, a circle, a square, a rectangle, or a triangle (Figs. 8 and 9 show a graphic displayed to show the risk of bending for the needle, the graphic shown can be interpreted as a shape as it would be obvious to add a third side to the triangle at a maximum depth of the needle).
Regarding claims 12 and 20, Halmann, Nields, and Yan disclose all the elements of the claimed invention as cited in claims 2 and 14.
Halmann further discloses wherein determining the deflection probability is based on a mathematical analysis for determining flex of a needle having the determined needle properties ([0051] – “The expected target region 682 represents an area within the ultrasound image 680 where the needle is expected based on the calculated risk of bending”, [0040] – “he processor 116 may also use additional factors when calculating the risk of bending such as a gauge of the needle, a stiffness of the needle 90 (which may be related to the gauge of the needle 90)”).
Claims 4 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Halmann (US 20160000399), Nields (US 20030073895), and Yan (US 20180132944) as applied to claims 2 and 14 above, and further in view of Sanbuichi (US 20120123295).
Regarding claims 4 and 16, Halmann, Nields, and Yan disclose all the elements of the claimed invention as cited in claims 2 and 14.
As cited above Nields teaches the input to select a biopsy needle.
Conversely Halmann does not teach wherein the input in the user interface indicates a make and model of the biopsy needle.
However Sanbuichi discloses wherein the input in the user interface indicates a make and model of the biopsy needle ([0127] – “opening information about the biopsy needle 10. The opening information recorder 286 may record in advance opening information related to the types and serial numbers of various biopsy needles 10, and supply the opening information depending on the type of the biopsy needle 10 which is indicated by the display control panel”).
The disclosure of Sanbuichi is an analogous art considering it is in the field of a needle biopsy procedure.
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 method and system of Halmann to incorporate the indication of a make and model of a biopsy needle of Sanbuichi to achieve the same results. One would have motivation to combine because it would allow one to more easily select the exact needle needed and the corresponding measurements.
Claims 7 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Halmann (US 20160000399), Nields (US 20030073895), and Yan (US 20180132944) as applied to claims 2 and 14 above, and further in view of Munrow (US 20140073911).
Regarding claims 7 and 18, Halmann, Nields, and Yan disclose all the elements of the claimed invention as cited in claims 2 and 14.
As cited above Halmann discloses the deflection probability indicator by disclosing the visual representation presenting the risk of bending.
Conversely Halmann does not teach wherein the […] probability indicator indicates a range of probabilities for the post-fire tip location.
However Yan discloses the post-fire tip location (Fig. 6, [0053] – “the (un-fired) needle tip is detected and the throw is added to estimate the location of the biopsy core if the needle were fired at that moment. Feedback is provided on whether the needle is positioned correctly to sample the target”).
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 method of Halmann to incorporate the post-fire tip location of Yan to achieve the same results. One would have motivation to combine because it would provide guidance for biopsy procedures requiring a needle gun.
Conversely Halmann and Yan do not teach wherein the […] probability indicator indicates a range of probabilities for the post-fire tip […].
However Munrow discloses wherein the […] probability indicator indicates a range of probabilities for the post-fire tip (Figs. 10A, 11A, 12A, 13A, 14A, and15A, “The safety boundary will differ from the treatment boundary in that the safety boundary will be set at a minimum threshold distance beyond the boundary of the tissue treatment region where the risk of damaging tissue is reduced or eliminated entirely”, therefore the boundaries are related to levels of risk/probability) […].
The disclosure of Munrow is an analogous art considering it is in the field of a guiding needle placement.
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 method and system of Halmann to incorporate the indication of a range of probabilities of Munrow to achieve the same results. One would have motivation to combine because it provide more detail to the visual representation of the risk of bending and therefore provide better guidance for needle placement.
Claims 8 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Halmann (US 20160000399), Nields (US 20030073895), and Yan (US 20180132944) as applied to claims 2 and 14 above, and further in view of Naidu (US 20170084022).
Regarding claims 8 and 19, Halmann, Nields, and Yan disclose all the elements of the claimed invention as cited in claims 2 and 14.
As cited above Halmann discloses the deflection probability indicator by disclosing the visual representation presenting the risk of bending.
Conversely Halmann does not teach wherein the […] probability indicator comprises a heatmap indicating a range of probabilities for the post-fire tip location.
However Yan discloses the post-fire tip location (Fig. 6, [0053] – “the (un-fired) needle tip is detected and the throw is added to estimate the location of the biopsy core if the needle were fired at that moment. Feedback is provided on whether the needle is positioned correctly to sample the target”).
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 method of Halmann to incorporate the post-fire tip location of Yan to achieve the same results. One would have motivation to combine because it would provide guidance for biopsy procedures requiring a needle gun.
Conversely Halmann and Yan do not teach wherein the […] probability indicator comprises a heatmap indicating a range of probabilities […].
However Naidu discloses wherein the […] probability indicator comprises a heatmap indicating a range of probabilities ([0026] – “the risk level can be identified through color coding the trajectory and/or a region around the trajectory, e.g., where red represents high risk, yellow represents medium risk and green represents low risk”) […].
The disclosure of Naidu is an analogous art considering it is in the field of providing a visual representation of risk for placement of a medical instrument.
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 method and system of Halmann to incorporate the color coding to depict a level of risk of Naidu to achieve the same results. One would have motivation to combine because it provide more detail to the visual representation of the risk of bending and “with this information, a user can accept or reject a current trajectory” (Naidu [0027]).
Claims 9 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Halmann (US 20160000399), Nields (US 20030073895), and Yan (US 20180132944) as applied to claim 2 above, and further in view of Boctor (US 20110237947).
Regarding claim 9, Halmann, Nields, and Yan disclose all the elements of the claimed invention as cited in claim 2.
As cited above Halmann teaches deflection probability for a post […insertion] tip location of the biopsy needle.
Conversely Halmann does not teach wherein determining the deflection probability is further based on tissue properties of the interior of the patient along a fire trajectory for the biopsy needle.
However Yan discloses a fire trajectory for the biopsy needle (Fig. 6, [0053] – “the (un-fired) needle tip is detected and the throw is added to estimate the location of the biopsy core if the needle were fired at that moment. Feedback is provided on whether the needle is positioned correctly to sample the target” [0048] – “a trajectory of the instrument is altered in accordance with the feedback”).
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 method of Halmann to incorporate the fire trajectory of Yan to achieve the same results. One would have motivation to combine because it would provide guidance for biopsy procedures requiring a needle gun.
Conversely Halmann and Yan do not teach wherein determining the deflection probability is further based on tissue properties of the interior of the patient along a […] trajectory for the […] needle.
However Boctor discloses wherein determining the deflection probability is further based on tissue properties of the interior of the patient along a […] trajectory for the […] needle ([0040] - "the present invention provides an elasticity map of the soft tissue under intervention that could be used to predict future needle deflection and compensate for it", it can be interpreted the deflection would be predicted along a trajectory of the needle).
The disclosure of Boctor is an analogous art considering it is in the field of facilitating proper planning of surgical procedures including needle insertion.
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 method of Halmann to incorporate the deflection probability based on tissue properties of Boctor to achieve the same results. One would have motivation to combine because ""Surgical TQM" refers to "total quality management," and it reflects the important role that the a system can play in reducing surgical errors and promoting better, more consistent outcomes" (Boctor - [0040]).
Regarding claim 11, Halmann, Nields, Yan, and Boctor disclose all the elements of the claimed invention as cited in claims 2 and 9.
Conversely Halmann does not teach further comprising determining the tissue properties by:
determining the fire trajectory for the biopsy needle based on the generated ultrasound image;
receiving elastography data for tissue along at least a portion of the fire trajectory for the biopsy needle; and
determining the tissue properties based on the received elastography data.
However Yan discloses determining the fire trajectory for the biopsy needle based on the generated ultrasound image ([0029] - "Before firing the biopsy gun, a display 118 can display a projected location of a biopsy core-taking portion based on a current position and orientation of a biopsy needle attached to the gun", [0036] discloses the detection of the needle within an 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 the method and system of Halmann to incorporate the fire trajectory of Yan to achieve the same results. One would have motivation to combine because it would provide guidance for biopsy procedures requiring a needle gun.
Conversely Halmann and Yan do not teach further comprising determining the tissue properties by:
receiving elastography data for tissue along at least a portion of the […] trajectory for the biopsy needle; and
determining the tissue properties based on the received elastography data.
However Boctor discloses determining the tissue properties by: receiving elastography data for tissue along at least a portion of the […] trajectory for the biopsy needle ([0040] – “the present invention provides an elasticity map of the soft tissue under intervention that could be used to predict future needle deflection and compensate for it”, [0050] – “merges both 3D ultrasound anatomy information with elasticity data”); and
determining the tissue properties based on the received elastography data ([0040] – “the present invention provides an elasticity map of the soft tissue under intervention that could be used to predict future needle deflection and compensate for it”, it can be interpreted tissue properties are determined from the elasticity map to predict deflection and compensate for it).
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 method of Halmann to incorporate the deflection probability based on tissue properties of Boctor to achieve the same results. One would have motivation to combine because "Surgical TQM" refers to "total quality management," and it reflects the important role that the a CIS system can play in reducing surgical errors and promoting better, more consistent outcomes" (Boctor - [0040]).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Halmann (US 20160000399), Nields (US 20030073895), Yan (US 20180132944), and Boctor (US 20110237947) as applied to claim 9 above, and further in view of Ponce (US 20080082110).
Regarding claim 10, Halmann, Nields, Yan, and Boctor disclose all the elements of the claimed invention as cited in claims 2 and 9.
Conversely Halmann does not teach wherein the tissue properties are based on user input identifying the tissue properties in the user interface.
However Ponce discloses wherein the tissue properties are based on user input identifying the tissue properties in the user interface ([0046] – “calculate using mathematical equations and/or numerical methods, the position of the instrument in the heterogeneous body structure or the probability of this position on the basis of the instrument data, the movement data and the body structure data. The device can comprise an input interface for inputting the aforesaid data”).
The disclosure of Ponce is an analogous art considering it is in the field of facilitating proper planning of surgical procedures including needle insertion.
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 method of Halmann to incorporate the user input identifying tissue properties of Ponce to achieve the same results. One would have motivation to combine because it would decrease the need for processing power to make calculations from diagnostic imaging data and it would allow the user to input tissue properties that may not be detected in imaging data.
Claims 13 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Halmann (US 20160000399), Nields (US 20030073895), and Yan (US 20180132944) as applied to claims 2 and 14 above, and further in view of Liu (US 20180089530).
Regarding claims 13 and 21, Halmann, Nields, and Yan disclose all the elements of the claimed invention as cited in claims 2 and 14.
Halmann discloses ultrasound imaging of a biopsy needle injection (Figs. 7-11, [0002] – “ultrasound guidance is often used to guide procedures such as positioning a biopsy needle”) and determining the deflection probability ([0040] – “The processor 116 may also use additional factors when calculating the risk of bending such as a gauge of the needle, a stiffness of the needle 90 (which may be related to the gauge of the needle 90), and whether or not the needle has penetrated the skin”).
Conversely Halmann does not teach further comprising: aggregating ultrasound image data for a plurality of insertions of biopsy needles into a patient; training a machine learning tool based on the aggregated ultrasound image data; and wherein determining the deflection probability is determined at least in part using the trained machine learning tool.
However Liu discloses further comprising: aggregating ultrasound image data for a plurality of insertions of biopsy needles into a patient; training a machine learning tool based on the aggregated ultrasound image data; and wherein determining the deflection probability is determined at least in part using the trained machine learning tool ([0013] – “the present invention utilize deep neural networks…Deep neural networks are machine learning based neural networks”, [0021] – “The deep neural network is trained based on a plurality of training images stored in a database. The training images can be 2D or 3D medical images acquired using any medical imaging modality, such as but not limited to…Ultrasound”, [0025] – “a probability map in which each voxel of the medical image is assigned a color corresponding to a detection probability calculated for that voxel by the trained deep neural network can be displayed on the display device”, therefore one with ordinary skill in the art would find it obvious in view of the teachings of Halmann and Liu to train a neural network based on a plurality of ultrasound images annotated with the risk of bending for a plurality of insertions of biopsy needles to provide data for the neural network to determine a probability/risk of bending in a new image).
The disclosure of Liu is an analogous art considering it is in the field of determining a probability and displaying which voxels fall within a probability.
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 method and system of Halmann to incorporate the machine learning tool to determine a probability within an image of Liu to achieve the same results. One would have motivation to combine because it would provide improved detection of a risk of bending by considering patterns in the aggregated ultrasound data.
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.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 2, 3, 5, 7-9, 11, 14, 15, and 17-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 6, 8, and 14 of U.S. Patent No. US12029499B2 in view of Nields (US 20030073895).
Regarding claims 2 and 14, claim 1 of US12029499B2 discloses a method for providing guidance for operation of a biopsy needle, the method comprising (claim 1 – “A method for providing guidance for operation of a biopsy needle, the method comprising:”): [claim 2]
an ultrasound probe (claim 1 – “an ultrasound probe”); [claim 14]
a display (claim 1 – “displaying, on a display”); [claim 14]
at least one processor operatively connected to the display and the ultrasound probe (claim 1 – “identifying, by a processor, within the generated image data… displaying, on a display operatively connected to the processor, an ultrasound image”); and [claim 14]
memory, operatively connected to the at least one processor, (claim 1 – “memory operatively connected to the processor”) comprising: [claim 14]
wherein the needle properties include at least one of a needle length, a needle gauge, a needle wall thickness, a needle material composition, a needle tip geometry, and a needle firing mechanism property (claim 1 – “the biopsy needle properties comprising at least one of a needle length, a needle gauge, a needle wall thickness, a needle material composition, a needle tip geometry, and a needle firing mechanism”);
based on the determined needle properties, determining a deflection probability for a post-fire tip location of the biopsy needle (claim 1 – “determining a deflection probability for a post-fire needle tip location based on at least one of: (1) experimental data for the type of biopsy needle and (2) the one or more stored properties of the biopsy needle”);
generating an ultrasound image from an ultrasound probe of an interior of a patient having at least a portion of the biopsy needle disposed therein (claim 1 – “generating image data from the reflected ultrasonic sound waves; identifying, by a processor, within the generated image data, at least a portion of the biopsy needle within the interior of the patient”);
identifying the at least a portion of the biopsy needle within the generated ultrasound image (claim 1 – “generating image data from the reflected ultrasonic sound waves; identifying, by a processor, within the generated image data, at least a portion of the biopsy needle within the interior of the patient”); and
based on the identification of the at least a portion of the biopsy needle and the determined deflection probability for the post-fire tip location of the biopsy needle, displaying a deflection probability indicator on the ultrasound image, wherein the deflection probability indicator indicates a range for the post-fire tip location based on the determined deflection probability (claim 1 – “based at least in part on the identification the portion of the biopsy needle, determining, by the processor, a predicted location of an aspect of the biopsy needle based at least in part on one or more biopsy needle properties…determining a deflection probability for a post-fire needle tip location based on at least one of: (1) experimental data for the type of biopsy needle and (2) the one or more stored properties of the biopsy needle…displaying a deflection probability indicator on the ultrasound image, wherein the deflection probability indicator indicates a range for the post-fire needle tip locations based on the determined deflection probability”).
Conversely claim 1 of US12029499B2 does not teach a system comprising: [claim 14]
storing instructions that when executed by the at least one processor perform a set of operations [claim 14]
displaying a user interface for selecting a type of biopsy needle of the biopsy needle to be used for a biopsy procedure;
receiving as input in the user interface, the input indicating the type of biopsy needle;
based on the input indicating the type of biopsy needle, determining needle properties for the biopsy needle,
However Nields discloses a system comprising ([0009] – “It is an object of the present invention to provide an enhanced imaging/biopsy system”): [claim 14]
storing instructions that when executed by the at least one processor perform a set of operation s([0020] – “operating the processor in response to an input regarding the operating mode to provide instructions for operating the medical device to obtain first and second images”) [claim 14]
displaying a user interface for selecting a type of biopsy needle of the biopsy needle to be used for a biopsy procedure (Figs. 16-20 show a user interface with a select needle button, [0088] – “a select needle button in the user input area”);
receiving as input in the user interface, the input indicating the type of biopsy needle ([0088] – “Such information can be entered by using the select needle button”);
based on the input indicating the type of biopsy needle, determining needle properties for the biopsy needle ([0088] – “a select needle button in the user input area. It will be appreciated that different biopsy needles have different dimensions which need to be accounted for in targeting the location of interest for sampling. Such information can be entered by using the select needle button”),
The disclosure of Nields is an analogous art considering it is in the field of providing guidance for needle biopsy procedures.
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 US12029499B2 to incorporate the input for selecting a needle to indicate needle properties of Nields to achieve the same results. One would have motivation to combine because it would allow one to easily select the dimensions of the needle and the dimensions “need to be accounted for in targeting the location of interest for sampling” (Nields – [0019]).
Regarding claims 3 and 15, US12029499B2 and Nields disclose all the elements of the claimed invention as cited in claims 2 and 14.
Claim 1 of US12029499B2 further discloses wherein the deflection probability indicator is based at least in part on a standard deviation of the range for the post-fire tip location (claim 1 – “wherein the deflection probability indicator is based at least in part on a standard deviation of the post-fire needle tip locations”).
Regarding claims 5 and 17, US12029499B2 and Nields disclose all the elements of the claimed invention as cited in claims 2 and 14.
Conversely US12029499B2 does not explicitly teach wherein the determining needle properties for the biopsy needle include querying a database containing the needle properties based on the input received from the user interface.
However Nields discloses wherein the determining needle properties for the biopsy needle include querying a database containing the needle properties based on the input received from the user interface ([0088] – “It will be appreciated that different biopsy needles have different dimensions which need to be accounted for in targeting the location of interest for sampling. Such information can be entered by using the select needle button”, therefore the dimensions are selected by selected by selecting the needle and therefore it can be interpreted the dimensions are queried from a database that contains the dimensions associated with each needle option).
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 US12029499B2 to incorporate the input for selecting a needle to indicate needle properties of Nields to achieve the same results. One would have motivation to combine because it would allow one to easily select the dimensions of the needle and the dimensions “need to be accounted for in targeting the location of interest for sampling” (Nields – [0019]).
Regarding claims 7 and 18, US12029499B2 and Nields disclose all the elements of the claimed invention as cited in claims 2 and 14.
Claim 1 of US12029499B2 further discloses wherein the deflection probability indicator indicates a range of probabilities for the post-fire tip location (claim 1 – “wherein the deflection probability indicator depicts a probability distribution for the post-fire needle tip location”).
Regarding claims 8 and 19, US12029499B2 and Nields disclose all the elements of the claimed invention as cited in claims 2 and 14.
Claim 14 of US12029499B2 discloses wherein the deflection probability indicator comprises a heatmap indicating a range of probabilities for the post-fire tip location (claim 14 – “wherein the deflection probability indicator comprises a heatmap”).
Regarding claim 9, US12029499B2 and Nields disclose all the elements of the claimed invention as cited in claim 2.
Claim 6 of US12029499B2 discloses wherein determining the deflection probability is further based on tissue properties of the interior of the patient along a fire trajectory for the biopsy needle (claim 6 – “wherein determining the deflection probability is further based on tissue properties of the interior of the patient along a fire trajectory for the biopsy needle”).
Regarding claim 11, US12029499B2 and Nields disclose all the elements of the claimed invention as cited in claims 2 and 9.
Claim 8 of US12029499B2 discloses further comprising determining the tissue properties by (claim 8 – “further comprising determining the tissue properties by”):
determining the fire trajectory for the biopsy needle based on the generated ultrasound image (claim 8 – “determining, by the processor, a fire trajectory for the biopsy needle based on the generated image data”);
receiving elastography data for tissue along at least a portion of the fire trajectory for the biopsy needle (claim 8 – “receiving elastography data for tissue along at least a portion of the fire trajectory for the biopsy needle”); and
determining the tissue properties based on the received elastography data (claim 8 – “determining the tissue properties based on the received elastography data”).
Claims 4 and 16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 6, 8, and 14 of U.S. Patent No. US12029499B2 and Nields (US 20030073895) as applied to claims 2 and 14 above, and further in view of Sanbuichi (US 20120123295).
Regarding claims 4 and 16, US12029499B2 and Nields disclose all the elements of the claimed invention as cited in claims 2 and 14.
As cited above Nields teaches the input to select a biopsy needle.
Conversely US12029499B2 and Nields do not teach wherein the input in the user interface indicates a make and model of the biopsy needle.
However Sanbuichi discloses wherein the input in the user interface indicates a make and model of the biopsy needle ([0127] – “opening information about the biopsy needle 10. The opening information recorder 286 may record in advance opening information related to the types and serial numbers of various biopsy needles 10, and supply the opening information depending on the type of the biopsy needle 10 which is indicated by the display control panel”).
The disclosure of Sanbuichi is an analogous art considering it is in the field of a needle biopsy procedure.
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 US12029499B2 to incorporate the indication of a make and model of a biopsy needle of Sanbuichi to achieve the same results. One would have motivation to combine because it would allow one to more easily select the exact needle needed and the corresponding measurements.
Claims 6, 12, and 20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 6, 8, and 14 of U.S. Patent No. US12029499B2 and Nields (US 20030073895) as applied to claims 2 and 14 above, and further in view of Halmann (US 20160000399).
Regarding claim 6, US12029499B2 and Nields disclose all the elements of the claimed invention as cited in claim 2.
Conversely US12029499B2 does not teach wherein the deflection probability indicator is one of an ellipse, a circle, a square, a rectangle, or a triangle.
However Halmann discloses wherein the deflection probability indicator is one of an ellipse, a circle, a square, a rectangle, or a triangle (Figs. 8 and 9 show a graphic displayed to show the risk of bending for the needle, the graphic shown can be interpreted as a shape as it would be obvious to add a third side to the triangle at a maximum depth of the needle).
The disclosure of Halmann is an analogous art considering it is in the field of providing guidance for a needle insertion procedure.
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 US12029499B2 to incorporate the shape of the probability indicator of Halmann to achieve the same results. One would have motivation to combine because it would allow for the shape of the probability indicator to be shown based on the plane of the ultrasound image.
Regarding claims 12 and 20, US12029499B2 and Nields disclose all the elements of the claimed invention as cited in claims 2 and 14.
Conversely US12029499B2 does not teach wherein determining the deflection probability is based on a mathematical analysis for determining flex of a needle having the determined needle properties.
However Halmann discloses wherein determining the deflection probability is based on a mathematical analysis for determining flex of a needle having the determined needle properties ([0051] – “The expected target region 682 represents an area within the ultrasound image 680 where the needle is expected based on the calculated risk of bending”, [0040] – “he processor 116 may also use additional factors when calculating the risk of bending such as a gauge of the needle, a stiffness of the needle 90 (which may be related to the gauge of the needle 90)”).
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 US12029499B2 to incorporate the mathematical analysis for determining flex of Halmann to achieve the same results. One would have motivation to combine because the flex of a needle would be dependent of properties of a needle therefore a mathematical analysis of the properties would provide a degree of flex of a needle.
Claim 10 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 6, 8, and 14 of U.S. Patent No. US12029499B2 and Nields (US 20030073895) as applied to claim 9 above, and further in view of Ponce (US 20080082110).
Regarding claim 10, US12029499B2 and Nields disclose all the elements of the claimed invention as cited in claims 2 and 9.
Conversely US12029499B2 does not explicitly teach wherein the tissue properties are based on user input identifying the tissue properties in the user interface.
However Ponce discloses wherein the tissue properties are based on user input identifying the tissue properties in the user interface ([0046] – “calculate using mathematical equations and/or numerical methods, the position of the instrument in the heterogeneous body structure or the probability of this position on the basis of the instrument data, the movement data and the body structure data. The device can comprise an input interface for inputting the aforesaid data”).
The disclosure of Ponce is an analogous art considering it is in the field of facilitating proper planning of surgical procedures including needle insertion.
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 US12029499B2 to incorporate the user input identifying tissue properties of Ponce to achieve the same results. One would have motivation to combine because it would decrease the need for processing power to make calculations from diagnostic imaging data and it would allow the user to input tissue properties that may not be detected in imaging data.
Claims 13 and 21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 6, 8, and 14 of U.S. Patent No. US12029499B2 and Nields (US 20030073895) as applied to claims 2 and 14 above, and further in view of Halmann (US 20160000399) and Liu (US 20180089530).
Regarding claims 13 and 21, US12029499B2 and Nields disclose all the elements of the claimed invention as cited in claims 2 and 14.
Conversely US12029499B2 does not teach further comprising: aggregating ultrasound image data for a plurality of insertions of biopsy needles into a patient; training a machine learning tool based on the aggregated ultrasound image data; and wherein determining the deflection probability is determined at least in part using the trained machine learning tool.
However Halmann discloses ultrasound imaging of a biopsy needle injection (Figs. 7-11, [0002] – “ultrasound guidance is often used to guide procedures such as positioning a biopsy needle”) and determining the deflection probability ([0040] – “The processor 116 may also use additional factors when calculating the risk of bending such as a gauge of the needle, a stiffness of the needle 90 (which may be related to the gauge of the needle 90), and whether or not the needle has penetrated the skin”).
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 US12029499B2 to incorporate the determination of deflection probability to be displayed in an ultrasound image of Halmann to achieve the same results. One would have motivation to combine because it allows one to visualize the risks involved with the current needle position so that one can determine if the needle position should be changed.
Conversely US12029499B2 and Halmann do not teach further comprising: aggregating ultrasound image data for a plurality of insertions of biopsy needles into a patient; training a machine learning tool based on the aggregated ultrasound image data; and wherein determining the deflection probability is determined at least in part using the trained machine learning tool.
However Liu discloses further comprising: aggregating ultrasound image data for a plurality of insertions of biopsy needles into a patient; training a machine learning tool based on the aggregated ultrasound image data; and wherein determining the deflection probability is determined at least in part using the trained machine learning tool ([0013] – “the present invention utilize deep neural networks…Deep neural networks are machine learning based neural networks”, [0021] – “The deep neural network is trained based on a plurality of training images stored in a database. The training images can be 2D or 3D medical images acquired using any medical imaging modality, such as but not limited to…Ultrasound”, [0025] – “a probability map in which each voxel of the medical image is assigned a color corresponding to a detection probability calculated for that voxel by the trained deep neural network can be displayed on the display device”, therefore one with ordinary skill in the art would find it obvious in view of the teachings of Halmann and Liu to train a neural network based on a plurality of ultrasound images annotated with the risk of bending for a plurality of insertions of biopsy needles to provide data for the neural network to determine a probability/risk of bending in a new image).
The disclosure of Liu is an analogous art considering it is in the field of determining a probability and displaying which voxels fall within a probability.
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 US12029499B2 to incorporate the machine learning tool to determine a probability within an image of Liu to achieve the same results. One would have motivation to combine because it would provide improved detection of a risk of bending by considering patterns in the aggregated ultrasound data.
Claims 2, 3, 5, 7-9, 11, 14, 15, and 17-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 6, 8, and 14 of U.S. Patent No. US12433692B2 in view of Nields (US 20030073895).
Regarding claims 2 and 14, claim 1 of US12433692B2 discloses a method for providing guidance for operation of a […] needle, the method comprising (claim 1 – “A method for providing guidance for operation of a needle having an inner member having a sharp tip configured to extend from the needle”): [claim 2]
an ultrasound probe (claim 1 – “an ultrasound probe”); [claim 14]
a display (claim 1 – “displaying, on a display”); [claim 14]
at least one processor operatively connected to the display and the ultrasound probe (claim 1 – “identifying, by a processor, within the generated image data… displaying, on a display operatively connected to the processor, an ultrasound image”); and [claim 14]
memory, operatively connected to the at least one processor, (claim 1 – “memory operatively connected to the processor”) comprising: [claim 14]
wherein the needle properties include at least one of a needle length, a needle gauge, a needle wall thickness, a needle material composition, a needle tip geometry, and a needle firing mechanism property (claim 1 – “the needle properties comprising at least one of a needle length, a needle gauge, a needle wall thickness, a needle material composition, a needle tip geometry, and a needle extension mechanism”);
based on the determined needle properties, determining a deflection probability for a post-fire tip location of the […] needle (claim 1 – “determining a deflection probability for an extended inner member location based on at least one of: (1) experimental data for the type of biopsy needle and (2) the one or more stored properties of the needle”);
generating an ultrasound image from an ultrasound probe of an interior of a patient having at least a portion of the […] needle disposed therein (claim 1 – “generating image data from the reflected ultrasonic sound waves; identifying, by a processor, within the generated image data, at least a portion of the needle within the interior of the patient”);
identifying the at least a portion of the […] needle within the generated ultrasound image (claim 1 – “generating image data from the reflected ultrasonic sound waves; identifying, by a processor, within the generated image data, at least a portion of the needle within the interior of the patient”); and
based on the identification of the at least a portion of the […]needle and the determined deflection probability for the post-fire tip location of the […] needle, displaying a deflection probability indicator on the ultrasound image, wherein the deflection probability indicator indicates a range for the post-fire tip location based on the determined deflection probability (claim 1 – “based at least in part on the identification the portion of the needle, determining, by the processor, a predicted location of an aspect of the inner member of the needle based at least in part on one or more needle properties…determining a deflection probability for an extended member location based on at least one of: (1) experimental data for the type of needle and (2) the one or more stored properties of the needle…displaying a deflection probability indicator on the ultrasound image, wherein the deflection probability indicator indicates a range for the extended inner member location based on the determined deflection probability”).
Conversely claim 1 of US12433692B2 does not teach a biopsy needle,
a system comprising: [claim 14]
storing instructions that when executed by the at least one processor perform a set of operations [claim 14]
displaying a user interface for selecting a type of biopsy needle of the biopsy needle to be used for a biopsy procedure;
receiving as input in the user interface, the input indicating the type of biopsy needle;
based on the input indicating the type of biopsy needle, determining needle properties for the biopsy needle,
However Nields discloses a biopsy needle ([0060] – “path of a biopsy needle”),
a system comprising ([0009] – “It is an object of the present invention to provide an enhanced imaging/biopsy system”): [claim 14]
storing instructions that when executed by the at least one processor perform a set of operation s([0020] – “operating the processor in response to an input regarding the operating mode to provide instructions for operating the medical device to obtain first and second images”) [claim 14]
displaying a user interface for selecting a type of biopsy needle of the biopsy needle to be used for a biopsy procedure (Figs. 16-20 show a user interface with a select needle button, [0088] – “a select needle button in the user input area”);
receiving as input in the user interface, the input indicating the type of biopsy needle ([0088] – “Such information can be entered by using the select needle button”);
based on the input indicating the type of biopsy needle, determining needle properties for the biopsy needle ([0088] – “a select needle button in the user input area. It will be appreciated that different biopsy needles have different dimensions which need to be accounted for in targeting the location of interest for sampling. Such information can be entered by using the select needle button”),
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 US12433692B2 to incorporate the input for selecting a needle to indicate needle properties of Nields to achieve the same results. One would have motivation to combine because it would allow one to easily select the dimensions of the needle and the dimensions “need to be accounted for in targeting the location of interest for sampling” (Nields – [0019]).
Regarding claims 3 and 15, US12433692B2 and Nields disclose all the elements of the claimed invention as cited in claims 2 and 14.
Claim 1 of US12433692B2 further discloses wherein the deflection probability indicator is based at least in part on a standard deviation of the range for the post-fire tip location (claim 1 – “wherein the deflection probability indicator is based at least in part on a standard deviation of the extended inner member location”).
Regarding claims 5 and 17, US12433692B2 and Nields disclose all the elements of the claimed invention as cited in claims 2 and 14.
Conversely US12433692B2 does not teach claims 5 and 17 therefore see the double patenting rejection above regarding claims 5 and 17.
Regarding claims 7 and 18, US12433692B2 and Nields disclose all the elements of the claimed invention as cited in claims 2 and 14.
Claim 1 of US12433692B2 further discloses wherein the deflection probability indicator indicates a range of probabilities for the post-fire tip location (claim 1 – “wherein the deflection probability indicator indicates a range for the extended inner member location based on the determined deflection probability”).
Regarding claims 8 and 19, US12433692B2 and Nields disclose all the elements of the claimed invention as cited in claims 2 and 14.
Claim 14 of US12433692B2 discloses wherein the deflection probability indicator comprises a heatmap indicating a range of probabilities for the post-fire tip location (claim 14 – “wherein the deflection probability indicator comprises a heatmap”).
Regarding claim 9, US12433692B2 and Nields disclose all the elements of the claimed invention as cited in claim 2.
Claim 6 of US12029499B2 discloses wherein determining the deflection probability is further based on tissue properties of the interior of the patient along a fire trajectory for the […] needle (claim 6 – “wherein determining the deflection probability is further based on tissue properties of the interior of the patient along an extension trajectory for the needle”).
Conversely claim 1 of US12433692B2 does not teach the biopsy needle,
However Nields discloses the biopsy needle ([0060] – “path of a biopsy needle”),
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 US12433692B2 to incorporate the biopsy needle of Nields to achieve the same results. One would have motivation to combine because it would allow one to have guidance while performing a biopsy procedure.
Regarding claim 11, US12433692B2 and Nields disclose all the elements of the claimed invention as cited in claims 2 and 9.
Claim 8 of US12029499B2 discloses further comprising determining the tissue properties by (claim 8 – “further comprising determining the tissue properties by”):
determining the fire trajectory for the […] needle based on the generated ultrasound image (claim 8 – “determining, by the processor, the extension trajectory for the needle based on the generated image data”);
receiving elastography data for tissue along at least a portion of the fire trajectory for the […] needle (claim 8 – “receiving elastography data for tissue along at least a portion of the extension trajectory for the needle”); and
determining the tissue properties based on the received elastography data (claim 8 – “determining the tissue properties based on the received elastography data”).
Conversely claim 1 of US12433692B2 does not teach the biopsy needle,
However Nields discloses the biopsy needle ([0060] – “path of a biopsy needle”),
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 US12433692B2 to incorporate the biopsy needle of Nields to achieve the same results. One would have motivation to combine because it would allow one to have guidance while performing a biopsy procedure.
Claims 4 and 16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 6, 8, and 14 of U.S. Patent No. US12433692B2 and Nields (US 20030073895) as applied to claims 2 and 14 above, and further in view of Sanbuichi (US 20120123295).
Regarding claims 4 and 16, US12433692B2 and Nields disclose all the elements of the claimed invention as cited in claims 2 and 14.
Conversely US12433692B2 does not teach claims 4 and 16 therefore see the double patenting rejection above regarding claims 4 and 16.
Claims 6, 12, and 20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 6, 8, and 14 of U.S. Patent No. US12433692B2 and Nields (US 20030073895) as applied to claims 2 and 14 above, and further in view of Halmann (US 20160000399).
Regarding claim 6, US12433692B2 and Nields disclose all the elements of the claimed invention as cited in claim 2.
Conversely US12433692B2 does not teach claim 6 therefore see the double patenting rejection above regarding claim 6.
Regarding claims 12 and 20, US12433692B2 and Nields disclose all the elements of the claimed invention as cited in claims 2 and 14.
Conversely US12433692B2 does not teach claims 12 and 20 therefore see the double patenting rejection above regarding claims 12 and 20.
Claim 10 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 6, 8, and 14 of U.S. Patent No. US12433692B2 and Nields (US 20030073895) as applied to claim 9 above, and further in view of Ponce (US 20080082110).
Regarding claim 10, US12433692B2 and Nields disclose all the elements of the claimed invention as cited in claims 2 and 9.
Conversely US12433692B2 does not teach claim 10 therefore see the double patenting rejection above regarding claim 10.
Claims 13 and 21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 6, 8, and 14 of U.S. Patent No. US12433692B2 and Nields (US 20030073895) as applied to claims 2 and 14 above, and further in view of Halmann (US 20160000399) and Liu (US 20180089530).
Regarding claims 13 and 21, US12433692B2 and Nields disclose all the elements of the claimed invention as cited in claims 2 and 14.
Conversely US12433692B2 does not teach claims 13 and 21 therefore see the double patenting rejection above regarding claims 13 and 21.
Conclusion
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/R.C.L./ Examiner, Art Unit 3797
/CHRISTOPHER KOHARSKI/ Supervisory Patent Examiner, Art Unit 3797
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