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 .
DETAILED ACTION
The amendment filed on August 11 is acknowledged and entered. Claims 1, 3-8, 11, 13-18 and 20 are amended. Claims 1-20 are pending and under examination in this Office action.
Response to Amendment
The rejection to claims 1-20 under 35 U.S.C. 101 is now withdrawn in view of the claim amendment.
The rejection to claims 1-6, 10-16 and 20 under 35 U.S.C. 102(a)(2), and the rejections to claims 7-9 and 17-19 are now withdrawn in view of Applicant’s arguments being persuasive. After reconsideration, new grounds of rejection are now made to the pending claims.
The non-statutory double patenting rejection to claims 1-4, 7-14 and 17-20 is now withdrawn in view of the terminal disclaimer filed and recorded on August 11, 2026.
Terminal Disclaimer
The terminal disclaimer filed on August 11, 2026 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of US Patent No. 11,877,888 has been reviewed and is accepted. The terminal disclaimer has been recorded.
Claim Interpretation - 35 USC § 112(f)
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: Claim 1: Claim limitation “at least one memory unit that stores instructions for processing” has been interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because it uses a generic placeholder “unit” coupled with functional language “that stores” without reciting sufficient structure to achieve the function. Furthermore, the generic placeholder is not preceded by a structural modifier that has a known structural meaning before the phrase “unit”.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
A review of the specification shows that the following appears to be the corresponding structure described in the specification for the 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph limitation: Claim 1: “at least one memory unit” refers to the specification as filed [0077]: examples of the memory unit 604 include but not limited to a fixed memory unit or a portable memory unit that can be inserted into the device.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
For more information, see MPEP § 2173 et seq. and Supplementary Examination Guidelines for Determining Compliance With 35 U.S.C. 112 and for Treatment of Related Issues in Patent Applications, 76 FR 7162, 7167 (Feb. 9, 2011).
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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 1-6, 10-16 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Bharat et al., US 2021/0259660 A1, hereinafter Bharat, in view of Cong et al., US 2020/0281662 A1, hereinafter Cong.
Claims 1-6, 10-16 and 20 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Bharat et al., US 2021/0259660 A1, hereinafter Bharat.
Claims 1, 11 and 20. Bharat teaches in FIG.1 a system (100), in FIGS.8, 13 and 14 a method (1300, 1400), and a computer program product (800) for providing guidance to an operator of an ultrasound device (Abstract: Ultrasound image devices, systems and methods are provided; and [0064]: FIG.8 is a schematic diagram illustrating an automated ultrasound probe position guidance scheme 800), comprising:
an ultrasound device (110) comprising an ultrasound probe housing that contains a plurality of probes (112) ([0028]: the system 100 is used for scanning an area or volume of a patient’s body. The system 100 includes an ultrasound imaging probe 110; [0029]: the probe 110 is an external ultrasound imaging device including a housing configured for handheld operation by a user; [0030]: the ultrasound transducer array 112 can include any suitable number of acoustic elements; and FIG.1);
at least one processor (134) connected with the ultrasound device through a data interface (136) and further connected to a display device (132) ([0037]: the processing component 134 is coupled to the communication interface 136; [0039]: the display 132 is coupled to the processing component 134; and FIG.1); and
at least one memory unit (138) that stores instructions for processing by the processor ([0040]: the host 130 may include a memory 138…the memory 138 can be configured to store an image data set 140 for deep learning-based training; and [0086]: steps of the method 1300 can be executed by a computing device, e.g., a processor), the instructions being configured to cause the processor to, during an insertion of a needle into a body of a patient ([0065]: the processing component can output instructions with visual indicators to the display to provide feedbacks and/or suggestions to the clinician on how to manipulate the probe position in real-time as shown in FIG.9):
receive images (302 and 1002) of inside the body of the patient generated in accordance with reflected ultrasonic waves from the probes of the ultrasound probe housing ([0029]: the transducer array 112 can be configured to obtain ultrasound data while the user grasps the housing of the probe 110…The probe 110 is configured to obtain ultrasound data of anatomy with the patient’s body; and [0030]: the transducer array 112 emits ultrasound signals towards an anatomical object 105 and receive echo signals reflected from the object 105 back to the transducer array 112; and [0087]: at step 1310, the method 1300 includes receiving an ultrasound image 302 and 1002 representative of a patient’s anatomy (e.g., the object 105) and an insertion of a biopsy needle);
process the received images to identify within the received images ([0041]: a deep learning network may be trained using ultrasound images of tissues including areas that are potentially malignant, target locations applied to the tissues for biopsies, and/or corresponding pathology results obtained from the biopsies)
a first body part of the body of the patient (105) that is a target of the needle ([0041]: the deep learning network may be trained to determine a biopsy target location; and [0043]: a biopsy may need to be performed on the nodule 212 to determine whether the nodule 212 is malignant or benign) that has been inserted into the body of the patient ([0041]: the deep learning network may be trained to…determine one or more biopsy needle paths to reach a target avoiding critical areas; and [0087]: At step 1310, the method 1300 includes receiving an ultrasound image (e.g., the images 302 and 1002) representative of a patient’s anatomy (e.g., the object 105) and an insertion of a biopsy needle; FIG.13, Step 1310: receive ultrasound image of subject’s tissue with insertion of biopsy needle) and
a second body part of the body of the patient that is not a target of the needle ([0043]: Some structures and/or tissues are critical structures or organ-at-risk (OAR) where a biopsy needle path needs to avoid – 220, 230 240 – Thus, when performing a biopsy on the nodule 212, the internal jugular vein 220, the carotid artery 230, and the trachea 240 cannot be along the biopsy needle path);
generate, based at least on the received images and the identification, modified images by (i) adding a first visual notification associated with the first body part and (ii) adding a second visual notification associated with the second body part ([0049]: FIG.4: the malignancy potential map 400 includes an overlay of OARs 410 and potential malignant tissue locations 420 and corresponding malignancy likelihoods on the image 440; and [0050]: FIG.5, the confidence map 500 can be displayed on the display 132 or the user interface 360. The confidence map 500 includes an overlay of confidence levels 510 (shown as a closed surface shape) corresponding to the malignancy likelihoods at the potential malignant locations 420…The confidence level 510 can be color-coded. For example, a color scheme 520 can use a first color (e.g., light blue) to represent a low confidence level and gradually transition to a second color (e.g., dark blue or red) to represent a high confidence levels) – the color that represents the high confidence level of being a malignancy tissue in the image 440 is the first visual notification, and the color that represents the low confidence level of being a malignancy tissue such as the OAR tissues that the needle path should avoid is the second visual notification; and
cause the modified images to be displayed by the display device ([0051]: FIGS.4 and 5 illustrate the malignancy potential map 400 and the confidence map 500 overlaid on the B-mode image 440).
Bharat does not teach that the first visual notification is a visual overlay over or in place of the first body part, the second visual notification is a visual overlay over or in place of the second body part, and generating the modified images comprises changing an appearance of at least one of the first visual overlay or the second visual overlay based on a distance or direction of the needle relative to the first body part or the second body part.
However, in an analogous ultrasound imaging-based needle insertion tracking and navigation field of endeavor, Cong teaches that
the visual notification is a visual overlay over or in place of the body part ([0085]: Either the image B or the image C in FIG. 7 may be the fusion image mentioned herein. The fusion image may be obtained by superimposing the three-dimensional volume mark on the two-dimensional real-time ultrasound image, or may be obtained by superimposing the three-dimensional volume mark on the three-dimensional real-time ultrasound image; and [0086]: the view data of the target tissue superimposed on the real-time ultrasound image may be the icon shown in FIG.7 so as to mark one or more of the target tissue shape, target tissue position, target tissue size, target tissue depth of the safety boundary at the corresponding position in the real-time ultrasound image; and
the visual overlay changes an appearance based on a distance or direction of the needle relative to the body part ([0086]: the view data of the target tissue superimposed on the real-time ultrasound image may be the icon shown in FIG.7 so as to mark one or more of the target tissue shape, target tissue position, target tissue size, target tissue depth of the safety boundary at the corresponding position in the real-time ultrasound image; and [0087]: In FIG.7, a straight line is used as an ablation device mark representing the ablation device…When the position of the ablation device mark on the real-time ultrasound image changes, the position of the predicted ablation area will change accordingly. When the orientation of the ultrasound probe changes, the ablation device mark and/or the predicted ablation area will change accordingly; [0104]: according to the relative fixed position relationship between the ablation needle and the ultrasound probe, the ablation needle may be displayed on the real-time ultrasound image, thereby determining the planned ablation path of the ablation needle based on the tracking positioning of the real-time ultrasound probe and the real-time ultrasound image and [0133]: the overlap area of the simulated ablation area and the certain tissue (safety boundary) with the real-time image may be superimposed and displayed on the real-time image with colors…It can be determined whether the ablation needle currently set can complete the ablation by observing whether the contrast enhanced section images of the certain tissue in different position are included in the colored joint predicted ablation area) – the “visual data”, which is the “mark”, is interpreted to be data that can be visualized, hence is referring to an appearance of the mark. Since there is a fixed position relationship between the ablation needle and the ultrasound probe, when the mark changes according to the position or the orientation change, it refers to a change in appearance of the visual overlay.
Hence, Cong teaches the particular position of the visual notification (being an overlay over or in place of its corresponding body part), and its appearance changes according to the change in distance or direction of the needle relative to the body part changes (referring to the position or orientation change of the ultrasound probe in view of the fixed relative position between the ultrasound probe and the ablation needle).
Since Bharat teaches the first visual notification associated with first body part and the visual notification associated with the second body part, when Bharat and Cong are combined, it teaches that the first visual notification is a visual overlay over or in place of the first body part, the second visual notification is a visual overlay over or in place of the second body part, and Bharat and Cong combined further teaches changing an appearance of at least one of the first visual overlay or the second visual overlay based on a distance or direction of the needle relative to the first body part or the second body part.
Therefore, it would have been obvious to one of the ordinary skilled in the art before the effective filing date of the claimed invention to have the visual notification in the system, the method and the computer program product of Bharat employ such features associated with a visual overlay over or in place of the body part, and the visual overlay changes an appearance based on a distance or direction of the needle relative to the body part, and as taught in Cong for the advantage of “providing a real-time needle insertion planning to ensure that the needle can be accurately inserted providing an increased effectiveness and decreased of an ablation treatment and a decreased risk of surgical treatment, as suggested in Cong, [0004].
Claims 2 and 12. Bharat and Cong combined teaches all the limitations of claims 1 and 11, respectively, including the first visual overlay and the second visual overlay (Bharat: [0049] and Cong: [0085] and [0086]).
Bharat further teaches that
the first visual overlay is a different color than the second visual overlay ([0050]: The confidence level 510 can be color-coded. For example, a color scheme 520 can use a first color (e.g., light blue) to represent a low confidence level and gradually transition to a second color (e.g., dark blue or red) to represent a high confidence levels).
Claims 3 and 13. Bharat and Cong combined teaches all the limitations of claims 1 and 11.
Bharat further teaches
process the received images to identify within the received images the needle ([0041]: the deep learning network may be trained to…determine one or more biopsy needle paths to reach a target avoiding critical areas; and [0087]: At step 1310, the method 1300 includes receiving an ultrasound image (e.g., the images 302 and 1002) representative of a patient’s anatomy (e.g., the object 105) and an insertion of a biopsy needle; FIG.13, Step 1310: receive ultrasound image of subject’s tissue with insertion of biopsy needle).
Cong further teaches that generating the modified images comprises
changing the appearance of the first visual overlay based on a distance or direction of the needle relative to the first body part ([0086]: the view data of the target tissue superimposed on the real-time ultrasound image may be the icon shown in FIG.7 so as to mark one or more of the target tissue shape, target tissue position, target tissue size, target tissue depth of the safety boundary at the corresponding position in the real-time ultrasound image; and [0087]: In FIG.7, a straight line is used as an ablation device mark representing the ablation device…When the position of the ablation device mark on the real-time ultrasound image changes, the position of the predicted ablation area will change accordingly. When the orientation of the ultrasound probe changes, the ablation device mark and/or the predicted ablation area will change accordingly; [0104]: according to the relative fixed position relationship between the ablation needle and the ultrasound probe, the ablation needle may be displayed on the real-time ultrasound image, thereby determining the planned ablation path of the ablation needle based on the tracking positioning of the real-time ultrasound probe and the real-time ultrasound image and [0133]: the overlap area of the simulated ablation area and the certain tissue (safety boundary) with the real-time image may be superimposed and displayed on the real-time image with colors…It can be determined whether the ablation needle currently set can complete the ablation by observing whether the contrast enhanced section images of the certain tissue in different position are included in the colored joint predicted ablation area).
Claims 4 and 14. Bharat and Cong combined teaches all the limitations of claims 1 and 11, respectively, including the first visual overlay and the second visual overlay (Bharat: [0049] and Cong: [0085] and [0086]), and their changes in appearance (Cong: [0086], [0087], [0104], and [0133]).
Bharat further teaches
changing a color of the first visual overlay; or changing an intensity of the first visual overlay ([0090]: At step 1340, the method 1300 includes displaying a warning to the clinician based on the detection on a display 132. For example, the warning can be in the form of a red light or any other suitable visual indicator on the display).
Claims 5 and 15. Bharat further teaches
process the received images to identify within the received images the needle ([0041]: the deep learning network may be trained to…determine one or more biopsy needle paths to reach a target avoiding critical areas; and [0087]: At step 1310, the method 1300 includes receiving an ultrasound image (e.g., the images 302 and 1002) representative of a patient’s anatomy (e.g., the object 105) and an insertion of a biopsy needle; FIG.13, Step 1310: receive ultrasound image of subject’s tissue with insertion of biopsy needle).
Cong further teaches that generating the modified images comprises
changing the appearance of the second visual overlay based on a distance or direction of the needle relative to the second body part ([0086]: the view data of the target tissue superimposed on the real-time ultrasound image may be the icon shown in FIG.7 so as to mark one or more of the target tissue shape, target tissue position, target tissue size, target tissue depth of the safety boundary at the corresponding position in the real-time ultrasound image; and [0087]: In FIG.7, a straight line is used as an ablation device mark representing the ablation device…When the position of the ablation device mark on the real-time ultrasound image changes, the position of the predicted ablation area will change accordingly. When the orientation of the ultrasound probe changes, the ablation device mark and/or the predicted ablation area will change accordingly; [0104]: according to the relative fixed position relationship between the ablation needle and the ultrasound probe, the ablation needle may be displayed on the real-time ultrasound image, thereby determining the planned ablation path of the ablation needle based on the tracking positioning of the real-time ultrasound probe and the real-time ultrasound image and [0133]: the overlap area of the simulated ablation area and the certain tissue (safety boundary) with the real-time image may be superimposed and displayed on the real-time image with colors…It can be determined whether the ablation needle currently set can complete the ablation by observing whether the contrast enhanced section images of the certain tissue in different position are included in the colored joint predicted ablation area).
Claims 6 and 16. Bharat and Cong combined teaches all the limitations of claims 1 and 11, respectively, including the first visual overlay and the second visual overlay (Bharat: [0049] and Cong: [0085] and [0086]), and their changes in appearance (Cong: [0086], [0087], [0104], and [0133]).
Bharat further teaches
changing a color of the second visual overlay; or changing an intensity of the second visual overlay ([0090]: At step 1340, the method 1300 includes displaying a warning to the clinician based on the detection on a display 132. For example, the warning can be in the form of a red light or any other suitable visual indicator on the display).
Claim 10. Bharat and Cong combined teaches all the limitations of claim 1.
Bharat further teaches
inserting a first descriptive label corresponding to the first body part; or inserting a second descriptive label corresponding to the second body part (FIGS. 4 and 5: the color bar on the right side of the image display has a descriptive label indicating the level of the potential malignancies (FIG.4, high to low) and the confidence level (FIG.5, high confidence to low confidence)).
Claims 7 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Bharat et al., US 2021/0259660 A1, hereinafter Bharat, in view of Cong et al., US 2020/0281662 A1, hereinafter Cong, further in view of Nakamura et al., US 2020/0121393 A1, hereinafter Nakamura.
Claims 7 and 17. Bharat and Cong combined teaches all the claims of claims 1 and 11, respectively.
Bharat further teaches the original images, the modified images, displaying the visual overlay with the original image, and displaying the modified image (FIGS.4-6 illustrate the original B-mode image 440, 440 and the visual overlay 430, 520, 610 and 620).
Neither Bharat nor Cong teaches that one of the images and a corresponding one of the modified images to be concurrently displayed by the display device.
To display multiple images concurrently or separately is considered alternatives of visual representation that would be obvious for one or ordinary skill in the art to achieve through routine experimentation, as evidenced by Nakamura.
Nakamura is in an analogous ultrasound-based needle insertion tracking field of endeavor. Nakamura teaches that the two images may be concurrently displayed in [0047]: FIG.5 is a screen shot of the output of an imaging software system showing a 3D image slice 300 and an indicator bar 350. Additional view of the slice image is shown 400 as well as additional information for planning and surgery.
The image panel 300 is the “one of the images” as claimed. The image panel 400 that comprises additional information for planning and surgery is the “one of the modified images” as claimed.
Therefore, it would have been obvious to one of the ordinary skilled in the art before the effective filing date of the claimed invention to have the system and method of Bharat and Cong combined employ such a feature of concurrently displaying two images as taught in Nakamura for the advantage of being an alternative of an image visualization arrangement for “supporting a needle placement process, planning, or assessment”, as suggested in Nakamura, [0011].
Claims 8 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Bharat et al., US 2021/0259660 A1, hereinafter Bharat, in view of Cong et al., US 2020/0281662 A1, hereinafter Cong, further in view of Shivanna et al., US 2009/0202179 A1, hereinafter Shivanna.
Claims 8 and 18. Bharat and Cong combined teaches all the claims of claims 1 and 11, respectively.
Bharat further teaches the original images, the modified images, displaying the visual overlay with the original image, and displaying the modified image (FIGS.4-6 illustrate the original B-mode image 440, 440 and the visual overlay 430, 520, 610 and 620).
Neither Bharat nor Cong teaches “responsive to user input, toggle between causing the images to be displayed by the display device and causing the modified images to be displayed by the display device”.
However, in an analogous medical image visualization arrangement field of endeavor, Shivanna teaches
responsive to user input, toggle between causing the images to be displayed by the display device and causing the modified images to be displayed by the display device ([0026]: The image properties of the selected regions of interest are modified without affecting other parts of the image…The original image is saved without any changes. There could be small or hidden markings on the image indicating the position of the edited regions of interest. By clicking on the markings, the region of interest can be accessed, displaying the edited changes. In an embodiment, the images are displayed as images coexisted with the edited region of interest. In an example, the edited region of interest may be displayed with the original image at the background).
Therefore, it would have been obvious to one of the ordinary skilled in the art before the effective filing date of the claimed invention to have the system and method of Bharat and Cong combined employ such a feature of “responsive to user input, toggle between causing the images to be displayed by the display device and causing the modified images to be displayed by the display device” as taught in Shivanna for the advantage of “providing an advanced imaging technique with which problems may be identifying through investigation of images to yield a better and accurate result”, as suggested in Shivanna, [0002].
Claims 8-9 and 18-19 are rejected under 35 U.S.C. 103 as being unpatentable over Bharat et al., US 2021/0259660 A1, hereinafter Bharat, in view of Cong et al., US 2020/0281662 A1, hereinafter Cong, further in view of King et al., US 2014/0037165 A1, hereinafter King.
Claims 8-9 and 18-19. Bharat and Cong combined teaches all the claims of claims 1 and 11, respectively.
Bharat further teaches the original images, the modified images, displaying the visual overlay with the original image, and displaying the modified image (FIGS.4-6 illustrate the original B-mode image 440, 440 and the visual overlay 430, 520, 610 and 620).
Neither Bharat nor Cong teaches “responsive to user input, toggle between causing the images to be displayed by the display device and causing the modified images to be displayed by the display device; and vary an opacity of the first visual overlay or the second visual overlay”.
However, in an analogous medical imaging feature visual presentation setting field of endeavor, King teaches
responsive to user input, toggle between causing the images to be displayed by the display device and causing the modified images to be displayed by the display device ([0055]: FIG.2, the touch screen 20 may also include at least one icon 28 which allows the user to enable/disable the overlay pattern, adjust the properties of the overlay pattern, and select which image data to which the overlay pattern will be applied); and
responsive to user input, vary an opacity of the first visual overlay or the second visual overlay ([0066]: the overlay pattern 30 and key 36 can be applied to the image in varying levels of opacity. The overlay may also include an indicator 38…Fig.3 illustrates the overlay 30 as a grid and key 36 applied at 100% opacity. Fig. 4 illustrates the overlay 30 and the key 36 both applied at 50% opacity. The properties of the overlay 30 can be constant or can vary across the display 32. For example, the overlay pattern 30 can be more opaque at the edges of the display 32 and gradually become more transparent toward the center of the display 32; and [0082]: …adjusting the properties of the overlay pattern, such as activation, deactivation, resolution, opacity, opacity distribution, color, brightness, thickness, and size. The software can also be configured to select the desired overlay pattern 30 in response to a user input 18).
Therefore, it would have been obvious to one of the ordinary skilled in the art before the effective filing date of the claimed invention to have the system and method of Bharat and Cong combined employ such a feature of “responsive to user input, toggle between causing the images to be displayed by the display device and causing the modified images to be displayed by the display device; and vary an opacity of the first visual overlay or the second visual overlay” as taught in King for the advantage of “improving communication during the surgical procedures by calling attention to or identifying certain areas of interest displayed on monitor to facilitate efficient and clear communication regarding a particular area of interest and diminish confusion, misunderstandings and misinterpretations”, as suggested in King, [0005].
Response to Arguments
Applicant’s arguments in regard to the rejection to claims 1-6, 10-16 and 20 under 35 U.S.C. (a)(2) have been fully considered and they are persuasive. Accordingly, the rejection has been withdrawn. Upon further search and consideration, the claims are now rejected under 35 U.S.C. as being unpatentable over Bharat and Cong combined, and a new non-final Office action is now issued.
The newly cited prior art Cong is now relied upon for the teaching of the visual notification being a visual overlay on or in place of its associated body part, and the appearance of the visual overlay changes when the position or direction of the needle relative to the body part changes.
Based on the above considerations, claims 1-20 remain rejected.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to YI-SHAN YANG whose telephone number is (408) 918-7628. The examiner can normally be reached Monday-Friday 8am-4pm PST.
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/YI-SHAN YANG/Primary Examiner, Art Unit 3798
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