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 .
Election/Restrictions
Applicant's election with traverse of Invention I (Claims 1-13) in the reply filed on 11/26/2025 is acknowledged. Claims 14-33 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. The traversal is on the grounds that the subject matter and utility of Invention I and Invention II are highly related. This is not found persuasive because:
While Inventions I and II are related, they are distinct. As further stated in MPEP § 802, “Restriction is the practice of requiring an applicant to elect a single claimed invention (e.g., a combination or subcombination invention, a product or process invention, a species within a genus) for examination when two or more independent inventions and/or two or more distinct inventions are claimed in an application”. MPEP § 806.05 discloses restriction practice for related inventions, with 806.05(e) specifically disclosing restriction between a process (Invention II) and apparatus for its practice (Invention I). As stated in the restriction requirement dated 09/26/2025, the inventions are distinct because the process/method (Invention II) does not require a display unit configured to produce a real-time or substantially real-time ultrasound image to provide visual feedback to an operator as required by the apparatus/system (Invention I), and thus the process as claimed (Invention II) may be practiced by another materially different apparatus (i.e. one without a display unit).
Applicant further argues the inventions are linked by a common special technical feature and thus form a single inventive concept, and therefore they should be examined together.
The particular choice of words/phrases used in applicant's argument (e.g., "linked by a common special technical feature" and "form a single general inventive conception [sic]") makes it sound like applicant is trying to argue that the inventions have Unity of Invention and therefore should not be restricted (e.g., MPEP 1893.03 (d) recites in part: "When making a lack of unity requirement, the examiner must (1) list the different groups of claims and (2) explain why each group lacks unity with each other group (i.e., why there is no single general inventive concept) specifically describing the unique special technical feature in each group."). However, the Unity of Invention analysis is only applicable international applications (PCT/WIPO) and national stage entries thereof under 35 USC 371, while the independent/distinctness analysis is applicable to national applications filed under 35 USC 111(a) (see MPEP 823 which recites in part "The analysis used to determine whether the Office may require restriction differs in national stage applications submitted under 35 U.S.C. 371 (unity of invention analysis) as compared to national applications filed under 35 U.S.C. 111(a) (independent and distinct analysis)."; further see MPEP 1893.03(d) recites in part "Examiners are reminded that unity of invention analysis (not an independent and distinct analysis) is applicable in national stage applications submitted under 35 U.S.C. 371. Restriction practice in accordance with 37 CFR 1.141 -1.146 continues to apply to U.S. national applications filed under 35 U.S.C. 111(a), even if the application filed under 35 U.S.C. 111(a) claims benefit under 35 U.S.C. 120 and 365(c) to an earlier international application designating the United States or to an earlier U.S. national stage application submitted under 35 U.S.C. 371."). This application is a national application filed under 35 USC 111(a), not a national stage entry under 35 USC 371 of an international application. Therefore the independent/distinctness analysis applies, not the Unity of Invention analysis. Thus, applicant's argument that "the inventions are linked by a common special technical feature/solution, and as such, the system and method form a single general inventive conception [sic], and they should be examined together" is not found to be persuasive.
The requirement is still deemed proper and is therefore made FINAL.
Priority
This application claims benefit from provisional application 63/543,638 filed 10/11/2023 and is a continuation of application 17/950,399 filed 09/22/2022 which claims benefit from provisional application 63/246,859 filed 09/22/2021.
Information Disclosure Statement
The information disclosure statement (IDS) submitted was filed on 01/08/2025. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference characters not mentioned in the description: reference characters 300, 302, and 304 in figure 3A-3C respectively are not found in the specification. Reference character “912” in figure 9 is also not found in the specification. In addition, reference character “506” in figure 5B has been used to designate both an ultrasound image and a medical instrument as disclosed in ¶ [0045] of the specification. Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add/correct the reference characters in the description in compliance with 37 CFR 1.121(b) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claim 2 is objected to because of the following informality:
“based one or more of” should be corrected to:
“based on one or more of”
Claim 13 is objected to because of the following informality:
“The method of claim 1” should be corrected to:
“The system of claim 1”
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-13 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites the limitation "for in-plane insertion of the medical instrument". There is insufficient antecedent basis for this limitation in the claim.
Claims 2-13 are rejected by virtue of dependency on rejected claim 1.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1, 4-5, and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Adams (US20230181153) in view of Sandy (US20140187945) and Halmann (US20150209003). Adams is cited in the IDS filed 01/08/2025.
Regarding claim 1, Adams teaches an ultrasound imaging and medical instrument guidance system (600) (Figs. 1-3 & 6, Abstract, [0052-0054], [0073-0074]) comprising:
an ultrasound probe (104) configured to transmit and receive acoustic signals from two or more ultrasonic arrays (105) for generating a sequence of ultrasound images (Figs. 1-3, [0053], [0062-0063], [0066], wherein the array of probes 105 to the left and to the right of the longitudinal slot 106 in figure 3A comprise two ultrasonic arrays), wherein the two or more ultrasonic arrays (105) are separated by a physical gap (106), said gap (106) positioned to allow for in-plane insertion of the medical instrument (102) relative to an ultrasound imaging plane, and wherein the gap (106) is dimensioned to accommodate the insertion of the medical instrument (102) into a patient's anatomy (Figs. 1-3, [0015], “wherein the needle being covered in the field of view of the ultrasound probe is displayed on the display device during insertion”, [0052], [0054]);
a display unit (610) configured to produce a real-time or substantially real-time ultrasound image to provide visual feedback to an operator (Fig. 6, [0073], [0079], “…displays the images on the display device 610 in real time”); and
a processor (602), and a storage (604) having encoded thereon executable instructions that, when executed by the processor (602) (Fig. 6, [0073], [0076], [0090]), cause the processor to carry out:
perform image and signal processing to reconstruct a sequence of ultrasound images from each of the two or more ultrasonic arrays (105) (Fig. 17, [0066], [0090], [0097], [0101-104]);
perform image and signal processing to quantify one or more of the following from the sequence of ultrasound images: (a) a relative motion of the medical instrument compared to surrounding biological tissue ([0098], wherein quantifying distance of a needle to a target during insertion by color coding depth in tissue surrounding the needle path comprises performing image/signal processing to quantify relative motion of a medical instrument compared to surrounding biological tissue), (b) properties of morphology of the medical instrument relative to surrounding biological tissue, (c) a combination of relative motion and properties of morphology of the medical instrument relative to surrounding biological tissue.
However, Adams fails to explicitly teach wherein the physical gap is at least 1 mm.
In an analogous ultrasound imaging and guidance system field of endeavor, Sandy teaches such a feature. Sandy teaches an ultrasound probe (10) with a pair of ultrasound transducer arrays (1, 2), (Figs. 1-5, Abstract, [0042-0045]). Sandy teaches the probe (10) includes a gap for needle manipulation, said gap separating the two arrays between 2 mm and 15 mm (Fig. 5, Abstract, [0025], [0042-0043]). Sandy therefore teaches two ultrasonic arrays separated by a physical gap of at least 1 mm.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Adams to have the physical gap be at least 2 mm as taught by Sandy (Fig. 5, [0025]). The at least 2 mm wide gap may allow for greater needle manipulation while maintaining quality ultrasound images as recognized by Sandy ([0025], [0042-0043]).
However the modified combination noted above fails to teach from an output of the image and signal processing, determine a likelihood that one or more pixels in the sequence of ultrasound images corresponds to the medical instrument; and alter one or more of the following for the pixels determined to likely correspond to the medical instrument: (a) an intensity relative to surrounding biological tissue, (b) a hue relative to surrounding biological tissue, (c) a saturation relative to surrounding biological tissue, or (d) a luminance relative to surrounding biological tissue.
In an analogous ultrasound imaging and guidance system field of endeavor, Halmann teaches such a feature. Halmann teaches an ultrasound probe (10) including a needle tracking system (40) (Fig. 1, [0011]). Halmann teaches calculating a probability or likelihood that pixels in an ultrasound image (82) correspond to a needle (30) (Abstract, [0002], [0015-0016]). Halmann teaches assigning a color to the pixels determined to correspond to the needle in the grayscale ultrasound image ([0003], [0019], [0022], [0024], wherein modifying a grayscale pixel determined to be a needle to have color comprises altering a hue relative to surrounding biological tissue). Halmann therefore teaches performing image and signal processing to determine a likelihood that one or more pixels in an ultrasound image corresponds to a medical instrument, i.e. a needle, and altering a hue of the pixels determined to correspond to the medical instrument, i.e. changing the grayscale pixel into a colored pixel.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Adams to determine the likelihood of a pixel being the needle and to assign a color to the pixels determined to be the needle as taught by Halmann (Abstract, [0002-0003], [0015-0016], [0019], [0022], [0024]). By colorizing pixels determined to correspond to the needle, the needle in the ultrasound image may be more easily visualized as recognized by Halmann ([0002-0003]), thereby aiding in needle guidance.
Regarding claim 4, Adams in view of Sandy and Halmann teaches the invention as claimed above in claim 1.
However, Adams fails to teach wherein the processor is further operative to carry out: inform the operator of one or more of the following: (a) a position of the medical instrument within the sequence of ultrasound images based on the pixel likelihood determination, (b) a calculated trajectory of the medical instrument based on the pixel likelihood determination, or (c) a comparison of a predicted trajectory of the medical instrument to a planned trajectory of the medical instrument.
In an analogous ultrasound imaging and guidance system field of endeavor, Halmann teaches such a feature. Halmann teaches an ultrasound probe (10) including a needle tracking system (40) (Fig. 1, [0011]). Halmann teaches calculating a probability or likelihood that pixels in an ultrasound image (82) correspond to a needle (30) (Abstract, [0002], [0015-0016]). Halmann teaches assigning a color to the pixels determined to correspond to the needle in the grayscale ultrasound image and generating/displaying a colorized image (88) ([0003], [0019], [0022-0024]). By assigning a color to the pixels determined to correspond with the needle and subsequently generating/displaying a colorized image with the needle colored, Halmann therefore teaches a processor operative to inform an operator of (a) a position of the medical instrument, i.e. needle, within a sequence of ultrasound images based on the pixel likelihood determination.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Adams to generate and display a colorized image with the needle colored based on the pixel likelihood determination as taught by Halmann (Abstract, [0002], [0015-0016], [0019], [0022-0024]). By displaying the image with the needle colored, a user or operator may predictably be informed of the position of the needle and use the display for guidance.
Regarding claim 5, Adams in view of Sandy and Halmann teaches the invention as claimed above in claim 4.
Adams further teaches wherein informing the operator includes conveying to the operator whether the medical instrument's trajectory is colinear or misaligned with a designated anatomical location visualized within said sequence of ultrasound images (Fig. 15B, [0097], “Processor 602 may further cause the needle overlay to change color depending on closeness to a target, or proximity to or alignment with a desired needle path”, wherein conveying alignment with a desired needle path, i.e. to a target, via color change comprises conveying to a user whether the instrument’s trajectory is colinear or misaligned with a designated anatomical location).
Regarding claim 7, Adams in view of Sandy and Halmann teaches the invention as claimed above in claim 1.
Adams further teaches wherein said ultrasound probe (104) comprises a dual-array geometry (105) (Figs. 1-3, [0053], [0063], wherein the array of probes 105 in figure 3A includes a left and right array separated by the longitudinal slot 106, therefore the probe 104 comprises a dual-array geometry) that enables a steep-angle medical instrument insertion through a center of a silhouette of the ultrasound probe (104) (Fig. 1, [0012], [0057], wherein the needle guide assembly can pivot between 0 to 180 degrees and wherein figure 1 shows a steep, i.e. vertical, angle insertion through the probe 104). Claims 1, 4-5, and 7
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Adams (US20230181153) in view of Sandy (US20140187945) and Halmann (US20150209003) as applied to claim 1 above, and further in view of Paltieli (US6626832). Adams is cited in the IDS filed 01/08/2025.
Regarding claim 2, Adams in view of Sandy and Halmann teaches the invention as claimed above in claim 1.
However, Adams fails to teach wherein the processor is further operative to carry out: quantify a predicted trajectory of the medical instrument based one or more of: (a) a quantification of the relative motion of the medical instrument compared to surrounding biological tissue, (b) one or more properties of morphology of the medical instrument relative to surrounding biological tissue, or (c) a combination thereof.
In an analogous ultrasound imaging and guidance system field of endeavor, Paltieli teaches such a feature. Paltieli teaches a system comprising an ultrasound transducer (8) and a needle (2) (Fig. 1, Abstract, Column 4 lines 15-20). Paltieli teaches a representation of an expected trajectory of a needle may be displayed on an ultrasound image (30) based on an evaluation of needle bending (Fig. 2D, Column 7 lines 15-28). Paltieli therefore teachings quantifying a predicted trajectory of a medical instrument, i.e. needle, based on properties of morphology of the medical instrument, i.e. bending of the needle, relative to surrounding biological tissue.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Adams to take into account the bending of the needle for predicting and displaying its trajectory as taught by Paltieli (Fig. 2D, Column 7 lines 15-28). The bending and/or curvature of the needle may predictably influence its trajectory and therefore should be taken into account as it would result in a more accurate prediction of a trajectory for needle guidance.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Adams (US20230181153) in view of Sandy (US20140187945), Halmann (US20150209003), and Paltieli (US6626832) as applied to claim 2 above, and further in view of Ferschel (DE102010039604; translation provided). Adams is cited in the IDS filed 01/08/2025.
Regarding claim 3, Adams in view of Sandy, Halmann, and Paltieli teaches the invention as claimed above in claim 2.
However, Adams fails to teach wherein the processor is further operative to carry out: measure one or more of: (a) a distance, (b), an angle, or (c) an error between the predicted trajectory of the medical instrument and a designated anatomical region.
In an analogous imaging and guidance system field of endeavor, Ferschel teaches such a feature. Ferschel teaches insertion of a needle and wherein the insertion may be monitored via ultrasound ([0046]). Ferschel teaches wherein a deviation of a real needle to a target point may be determined ([0052]). Ferschel teaches wherein the deviation is the minimum distance (D) between the predicted trajectory (23) of the needle to a planned target point (6) (Fig. 4, [0052-0053]). Ferschel further teaches wherein the methods described may be implemented by a computer program and thus processor ([0029]). Ferschel therefore a processor operative to teaches measure distance and/or error between a predicted trajectory of a medical instrument and a designed anatomical region.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Adams to calculate a distance or error between the predicted trajectory and the planned target as taught by Ferschel (Fig. 4, [0052-0053]). The distance/error may be displayed to a user as recognized by Ferschel (Fig. 4, [0054]) and thus help guide the user in correcting the orientation or trajectory of the needle.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Adams (US20230181153) in view of Sandy (US20140187945) and Halmann (US20150209003) as applied to claim 5 above, and further in view of Mauldin (US20160374644). Adams is cited in the IDS filed 01/08/2025.
Regarding claim 6, Adams in view of Sandy and Halmann teaches the invention as claimed above in claim 5.
However, Adams fails to teach wherein informing the operator includes providing a visual indication, and wherein an appearance of the visual indication is altered based on a calculation of misalignment of the medical instrument’s trajectory with the designated anatomical location.
In an analogous ultrasound imaging and guidance system field of endeavor, Mauldin teaches such a feature. Mauldin teaches an ultrasound apparatus (100) for generating and displaying ultrasound images (Fig. 1, [0058]). Mauldin teaches in several embodiments, the device (200; 300) includes a needle guide (210; 340) for needle insertion (Figs. 2-3, [0080], [0083]). Mauldin teaches determining alignment between the needle path and a target anatomy and displaying a corresponding visual indicator for when the needle path is aligned and for when the needle path is misaligned (Figs. 6-7, [0098], [0101]). Mauldin teaches the visual indicators may provide directional feedback, i.e. when misaligned, and one of the indicators (950) denotes no translation is necessary, i.e. when aligned (Figs. 8-9, [0104-0105]). Mauldin therefore teaches providing a visual indication and wherein the indication is altered based on a calculation of misalignment of the medical instruments (needle’s) trajectory with a target, to provide direction feedback and to confirm alignment.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Adams to include visual indicators indicating alignment and misalignment as taught by Mauldin (Figs. 6-9, [0098], [0104-0105]). Altering the visual indicator based on a misalignment calculation, i.e. providing a directional indicator on how to manipulate/translate the needle to align with a target, may predictably assist a user in guiding a needle towards a target.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Adams (US20230181153) in view of Sandy (US20140187945) and Halmann (US20150209003) as applied to claim 7 above, and further in view of Boner (US4681103). Adams is cited in the IDS filed 01/08/2025.
Regarding claim 8, Adams in view of Sandy and Halmann teaches the invention as claimed above in claim 7.
Adams teaches wherein the longitudinal slot (106) is positioned at a centerline of the ultrasound probe (104) and includes a needle guide (108) positioned therein (Figs. 1-2, [0054]).
However, Adams fails to teach the invention further comprising an affixed apparatus to constrict movement of the medical instrument trajectory that spans between -30 and 30 degrees relative to the centerline of the ultrasound probe.
In an analogous ultrasound imaging and guidance system field of endeavor, Boner teaches such a feature. Boner teaches an instrument guide for use in conjunction with an ultrasound probe (Abstract). Boner teaches a swivel ball (26) configured to hold a needle (40) and needle guide (44) (Fig. 9, Column 4 lines 5-11 and 44-46). Boner teaches the swivel ball is constrained to a sweep of 60 degrees, i.e. 30 degrees from vertical in every direction (Fig. 9, Column 4 lines 12-17). Boner therefore teaches an apparatus configured to constrict movement of a medical instrument trajectory, i.e. needle, that spans between -30 and 30 degrees relative to a vertical.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Adams to further include a swivel ball or mechanism to constrain the needle guide and thus needle to a pivot range between -30 to 30 degrees from vertical as taught by Boner (Fig. 9, Column 4 lines 12-17). Boner recognizes this pivot range to be optimal and/or effective (Column 4 lines 14-17). Since Adams teaches wherein the longitudinal slot and needle guide are positioned at a centerline of the ultrasound probe, Adams modified by the teaching of Boner to include a mechanism such as a swivel ball to constrain the needle/needle guide would predictably result wherein the medical instrument trajectory (needle path) spans between -30 and 30 degrees relative to a centerline of the ultrasound probe.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Adams (US20230181153) in view of Sandy (US20140187945) and Halmann (US20150209003) as applied to claim 1 above, and further in view of Meglan (US20220395334). Adams is cited in the IDS filed 01/08/2025.
Regarding claim 9, Adams in view of Sandy and Halmann teaches the invention as claimed above in claim 1.
However, Adams fails to teach wherein the processor is further operative to carry out: operate one or more machine learning networks that are trained to quantify one or more of: (a) relative motion of the medical instrument compared to surrounding biological tissue, (b) properties of morphology of the medical instrument relative to surrounding biological tissue, or (c) combinations thereof.
In an analogous ultrasound imaging and guidance system field of endeavor, Meglan teaches such a feature. Meglan teaches an imaging device (124; 320) which may capture ultrasound images ([0042], [0069]). Meglan further teaches capturing images of a tool (340) with the device (320) during a procedure (Fig. 3, [0069]). Meglan teaches a machine learning system (260) may process the images to identify a type, shape, and size of the tool (340) ([0071], [0082], wherein the machine learning system identifying a shape and size of a tool from an image of the tool in tissue comprises quantifying properties of morphology of a medical instrument relative to surrounding biological tissue). Meglan further teaches wherein the machine learning system (260) is trained to identify the type, shape, and size of a tool ([0044], [0047]). Meglan teaches wherein the machine learning system may include convolutional neural networks ([0058]). Moreover, Meglan teaches wherein a processor is operable to execute instructions including identification of the tool by the machine learning system ([0016]). Meglan therefore teaches a processor operative to carry out the use of a machine learning network trained to quantify properties of morphology, i.e. shape/size, of the medical instrument (tool) relative to surrounding biological tissue.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Adams to have the processor be operable to use a machine learning network trained to quantify the size and shape of the medical instrument as taught by Meglan ([0016], [0044], [0047], [0058]). By quantifying the size and/or shape of the tool, an indication may be provided to an operator that the tool is not the appropriate shape or size for a certain procedure as recognized by Meglan ([0044], [0074-0075]).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Adams (US20230181153) in view of Sandy (US20140187945) and Halmann (US20150209003) as applied to claim 1 above, and further in view of Bharat (US20210259660). Adams is cited in the IDS filed 01/08/2025.
Regarding claim 10, Adams in view of Sandy and Halmann teaches the invention as claimed above in claim 1.
However, Adams fails to teach wherein the processor is further operative to carry out: operate one or more machine learning networks that are trained to estimate a trajectory and/or a predicted future location of the medical instrument.
In an analogous ultrasound imaging and guidance system field of endeavor, Bharat teaches such a feature. Bharat teaches an ultrasound imaging system (100) including an ultrasound imaging probe (110) (Fig. 1, [0028]). Bharat teaches using ultrasound imaging guidance with the probe (110) for needle insertion (Fig. 7, [0062]). Bharat further teaches wherein the system (100) may train and use the trained deep learning network (310) to predict a needle path (350) (Fig. 3, [0041-0042], [0044], [0054]). Moreover, Bharat teaches wherein a processor (134) applies the deep-learning technique to determine the needle path ([0038]). Bharat therefore teaches a processor operative to operate a trained machine learning network to estimate a trajectory and/or predicted future location of a medical instrument (path of needle).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Adams to use a trained deep learning network to estimate a needle trajectory as taught by Bharat (Fig. 3, [0038], [0041-0042], [0044], [0054]). The needle trajectory estimated by the deep learning network may provide for an optimal trajectory which avoids intersection with critical structures as recognized by Bharat ([0038], [0042], [0054], [0057]).
Claims 11-12 are rejected under 35 U.S.C. 103 as being unpatentable over Adams (US20230181153) in view of Sandy (US20140187945) and Halmann (US20150209003) as applied to claim 1 above, and further in view of Perrey (US20180140279). Adams and Perrey are cited in the IDS filed 01/08/2025.
Regarding claim 11, Adams in view of Sandy and Halmann teaches the invention as claimed above in claim 1.
However, Adams fails to teach wherein the two or more ultrasound arrays are configured to emit high intensity ultrasound that generates sufficient acoustic radiation force to generate biological tissue motion.
In an analogous ultrasound imaging and guidance system field of endeavor, Perrey teaches such a feature. Perrey teaches an ultrasound system (100) including an ultrasound probe (104) comprising an ultrasound transducer array (Fig. 1, [0021-0022]). Perrey teaches wherein the ultrasound system (100) is operable to provide an enhanced detection and visualization of a surgical needle (10) by performing shear wave elasticity imaging ([0021]). Perrey teaches wherein the ultrasound system (100) or transducer array (104) may provide a push force, such as a high intensity ultrasound push pulse (105), for generating shear waves (5) in tissue (1), causing displacement of the tissue (1) (Fig. 1, [0021], [0023], [0037], wherein the “push force” generated by ultrasound comprises acoustic radiation force). Perrey therefore teaches an ultrasound transducer array configured to emit high intensity ultrasound that generate sufficient acoustic radiation force to generate biological tissue motion.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Adams to have the ultrasound transducer arrays be configured to emit high intensity ultrasound such that tissue is displaced via a push force as taught by Perrey (Fig. 1, [0021-0023], [0037]). By causing tissue displacement, shear wave elasticity imaging may be performed, thereby providing enhanced detection and visualization of a surgical needle as recognized by Perrey ([0021], [0031], [0043]). Since Adam teaches wherein the probe comprises two ultrasound transducer arrays, Adams modified by the teachings of Perrey would predictably result wherein both arrays are configured for emitting high intensity ultrasound which generates sufficient acoustic radiation force to generate biological tissue motion.
Regarding claim 12, Adams in view of Sandy and Halmann teaches the invention as claimed above in claim 1.
However, Adams fails to teach wherein an external vibration source generates biological tissue motion.
In an analogous ultrasound imaging and guidance system field of endeavor, Perrey teaches such a feature. Perrey teaches an ultrasound system (100) including an ultrasound probe (104) comprising an ultrasound transducer array (Fig. 1, [0021-0022]). Perrey teaches wherein the ultrasound system (100) is operable to provide an enhanced detection and visualization of a surgical needle (10) by performing shear wave elasticity imaging ([0021]). Perrey teaches wherein the system (100) includes an external vibration device (20) configured to provide an external push force (22) for displacing tissue to create shear waves (5) in the tissue (1) (Fig. 1, Claim 3, [0021], [0037], [0044]). Perrey therefore teaches an external vibration source which generates biological tissue motion.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Adams to include an external vibration device for generating tissue displacement as taught by Perrey (Fig. 1, Claim 3, [0021], [0037], [0044]). The tissue displacement caused by the external vibration device may be imaged via shear wave elasticity imaging which may provide enhanced detection and visualization of a surgical needle as recognized by Perrey ([0021], [0031], [0048]).
Claims 13 is rejected under 35 U.S.C. 103 as being unpatentable over Adams (US20230181153) in view of Sandy (US20140187945) and Halmann (US20150209003) as applied to claim 1 above, and further in view of Mochizuki (US20170281136).
Regarding claim 13, Adams in view of Sandy and Halmann teaches the invention as claimed above in claim 1.
However, Adams fails to teach wherein the ultrasound probe is configured to steer transmitted ultrasound energy from each of the two or more ultrasound arrays along a sequence of two or more unique angles to quantify a relative motion of the medical instrument, one or more morphological properties of the medical instrument, or combinations thereof.
In an analogous ultrasound imaging and guidance system field of endeavor, Mochizuki teaches such a feature. Mochizuki teaches an ultrasound diagnostic apparatus (10) including an ultrasound probe (11) and a needle (12) (Fig. 1, Abstract, [0019]). Mochizuki teaches wherein the needle (12) is mounted on the ultrasound probe (11) via a needle guide (Fig. 1, [0025]). Mochizuki teaches acquiring a plurality of time-sequential images corresponding to a plurality of different steering angles, i.e. angles of 15°, 30°, and 45° (Fig. 5B, [0060]), therefore teaching steering of ultrasound energy along a sequence of two or more unique angles. Mochizuki teaches the needle (12) in motion may be extracted based on a motion vector calculated between the time-sequential images ([0060]). Mochizuki therefore teaches quantifying a relative motion of a medical instrument (motion vector of a needle) by steering ultrasound energy along a sequence of two or more unique angles.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Adams to acquire ultrasound images from a plurality of different steering to calculate a motion vector of a needle as taught by Mochizuki (Fig. 5B, [0060]). By acquiring images from a plurality of different steering angles, one image may be chosen in which the echo signal from the needle is the strongest and thus provide for an image with enhanced visualization of the needle as recognized by Mochizuki ([0059-0060]). Modifying Adams with the teachings of Mochizuki to acquire images at a plurality of steering angles would predictably result wherein the two ultrasound transducer arrays of Adams would be configured to steer transmitted ultrasound energy along a sequence of two or more unique angles to quantify a relative motion, i.e. motion vector, of the medical instrument (needle).
Conclusion
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/TOMMY T LY/ Examiner, Art Unit 3797
/SERKAN AKAR/ Primary Examiner, Art Unit 3797