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 .
Response to Arguments
New 35 U.S.C. 112(b) rejections are necessitated by amendment.
Regarding 35 U.S.C. 101
Applicant's arguments filed 06/02/2026 have been fully considered but they are not persuasive.
For example, applicant argues “first amended independent claim 1 recites a particular machine that is integral to the claim . For example, claim 1 positively recites ‘an ultrasound probe comprising a transducer array,’ which a person or ordinary skill in the art would recognize is a particular machine. The ‘ultrasound probe comprising a transducer array’ is not recited at a high level of generality; it names a specific medical imaging device with a specific component. Practice of any potential judicial exception requires and relies upon the particular machine recited in the claims” (REMARKS pg. 8). Examiner respectfully disagrees in that an ultrasound probe comprising a transducer array is highly generic in the field of ultrasound and does not amount to a particular machine, but rather amounts to use of a generic component of an ultrasound system used for mere data gathering. In other words, merely reciting a generic component of an ultrasound system for acquiring data in the field of ultrasound imaging is not found to amount to a particular machine and applicant’s arguments are not found persuasive.
Applicant further argues “this specific combination of features restructures the point-of-care (POC) ultrasound workflow by guiding a non-expert user through multi-view image acquisition and then providing a structured visual explanation of how the staging determination was reached. This permits ‘a non-expert user to obtain ultrasound images of a patient anatomy including multiple views of sufficient quality for analysis’ and permits the user to ‘be more confident that the resulting staging value is accurate’ by ‘displaying the user the images acquired and/or selected, as well as the corresponding sub-scores’ (REMARKS Pg. 9-10). Examiner respectfully disagrees in that the claims are so broadly recited that there is not sufficient NEXUS between the claimed invention and the supposed improvement. For example, applicant’s arguments that the non-expert user would obtain ultrasound images of ‘sufficient quality for analysis’ is not reflected by the currently claims as the claims merely recite outputting user guidance to obtain a plurality of ultrasound images corresponding to a plurality of views of a patient anatomy without any specificity as to such guidance, where user guidance may merely be an instruction to “acquire ultrasound images corresponding to a plurality of views of a patient anatomy” via display without any specificity which would lead to sufficient/higher quality images. Furthermore, regarding the supposed improvement that displaying the user the images acquired as well as the corresponding sub-scores would permit the user to be more confident that the resulting staging value is accurate, examiner notes that the claims remain to be broad and read on displaying any of the ultrasound images, the indication of the image features, and the corresponding sub-score without any implicit nor explicit NEXUS to the supposed improvement of permitting the user to be more confident. Examiner notes that the specification provides further detail to such an improvement (e.g. selection of an image which most strongly correlates to the liver-kidney contrast features, and displaying the selected ultrasound image, the corresponding feature and features score which may help a non-expert user in the ultrasound image to trust the results of the method 300), however, such features are not required of the claims as currently recited and are not considered an additional element with respect to significantly more/practical application consideration. Applicant’s arguments with respect to step 2A are therefore not found persuasive.
Applicant further argues “applicant submits that a person of ordinary skill in the art would recognize this combination of elements is not well-understood, routine, or conventional” (REMARKS pg. 10-11). Examiner respectfully disagrees in that the output of data (i.e. calculated/determined data and images) is considered to amount to merely insignificant post-solution activity of displaying/outputting data and applicant has not provided any evidence/further arguments as to why such display of the information is not well-understood, routine, or conventional other than saying so. Applicant’s arguments are thus found merely conclusory without any sufficient evidence as to why the combination of elements with respect to the output are anything other than mere data display which is well-understood, routine, and conventional especially in the field of ultrasound. For at least these reasons, applicant’s arguments with respect to step 2B are therefore not found persuasive.
Regarding prior art
Applicant's arguments filed 06/02/2026 have been fully considered but they are not persuasive. For example, applicant argues Even accepting the rationale in the Office Action, p. 9, arguendo, that it would have been obvious to display the staging value and sub-scores as generic ‘data generated by the system,’ this does not disclose or suggest the specific ‘visual representation of how the staging value was determined’ recited by amended claim 1. In particular, claim 1 requires a display that presents the ultrasound image together with an indication of the corresponding image feature identified within that image and the corresponding sub-score, which visually explains to the user the basis upon which the staging determination was made. Klochko’s display of a binary presence-or-absence indication, or even scores and grades in isolation, is fundamentally different from the claimed visual representation that ties together her ultrasound image, the identified feature, and the sub-score to show the user how the staging value was determined. Thus, Klochko does not disclose or suggest all of the recited features of claim 1” (REMARKS pg. 12-13). Examiner respectfully disagrees in that Klochko explicitly teaches displaying a visual representation of how the staging value was determined including the ultrasound image and an indication of the feature. Displaying additional data such as the staging value and the sub-score associated with the image would have been an obvious modification to the system of Klochko, especially in light of Klochko’s disclosure that other data generated by the system may be displayed. Displaying data generated by a system especially display of such data together with the ultrasound image from which the data is calculated/generated such as the sub-score associated with the ultrasound image and the grade calculated therefrom would have been an obvious modification to the system of Klochko in order to provide a full-picture of the examination to a user accordingly. Nonetheless, Examiner has provided an alternative rejection to include teachings in which a display includes a visual representation including an ultrasound image, an indication of a feature, and a score.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception in the form of an abstract idea without significantly more.
In a test for patent subject matter eligibility, the claims pass Step 1 (see 2019 Revised Patent Subject Matter Eligibility), as they are related to a process, machine, manufacture, or composition of matter.
When assessed under Step2A, Prong I, Independent claims 1 and 15 are found to recite a judicial exception (i.e. abstract idea). In this instance, claims 1 and 15 recite the limitation “identify/ing a plurality of image features associated with a medical condition of the patient within the plurality of ultrasound images”, “determine/determining a plurality of sub-scores for the plurality of image features”, and “determine/determining a staging value representative of a progression of the medical condition based on the plurality of sub-scores”. The cited limitations, under their broadest reasonable interpretation, encompass a mental process (i.e. abstract idea) of identifying and determining which can be performed in the mind or by a human using a pen and a paper (e.g. observation, evaluation, judgment, opinion). In other words, a person could reasonably identify features within images via observation/evaluation, determine scores for the features via evaluation/judgment/opinion, and determine a staging value via evaluation/judgment/opinion. Examiner notes that with the exception of generic computer-implemented steps (e.g. “a processor” recited in claim 1 and “computer implemented method” recited in claim 15), there is nothing in the claims that preclude the limitation from being performed by a human, mentally or with pen and paper, thus the cited limitation(s) recites a judicial exception (MPEP 2106.04(a)) and the claim must be reviewed under Step 2A, Prong II to determine patent eligibility.
Step 2A, Prong II determines whether any claim recites an additional element that integrates the judicial exception into a practical application. Independent claims recites the following additional element(s):
An ultrasound probe comprising a transducer array (claim 1); and
A processor configured for communication with a display and the transducer array of an ultrasound probe (Claim 1)
Output/outputting, to the display, user guidance to obtain a plurality of ultrasound images corresponding to a plurality of views of a patient anatomy
Control/controlling the transducer array to obtain a plurality of ultrasound images corresponding to a plurality of views;
Output/outputting, to the display a screen display comprising: the staging value and a visual representation of how the staging value was determined, wherein the visual representation comprises at least one ultrasound image of the plurality of ultrasound images, an indication of a corresponding image feature in the at least one ultrasound image, and a corresponding sub-score.
The additional elements in the cited independent claims are not found to integrate the judicial exception into a practical application. In this case, the ultrasound probe and processor configured for communication with a display and the transducer array are seen as merely generic components of an ultrasound system and does not more than link the judicial exception to a particular technological environment or field of use and further amounts to merely applying the judicial exception with a generic computer. Outputting, to the display, user guidance to obtain a plurality of ultrasound images corresponding to a plurality of views of a patient anatomy and controlling the transducer array to a plurality of ultrasound images is seen as merely insignificant pre-solution activity of outputting data and data gathering. Furthermore, outputting, to the display, the display screen as recited is seen as merely insignificant post-solution activity of outputting/displaying data/results. These elements are seen as adding insignificant extra-solution activity to the judicial exception. Therefore, under step 2A Prong II the Judicial exception is not integrated into a practical application by additional elements of independent claims 1 and 15 and the claims must be reviewed under Step 2B to determine patent eligibility.
Step 2B determines where a claim amounts to significantly more.
The additional elements listed above do not amount to significantly more than the judicial exception. In this instance, as noted above the additional elements are seen as merely linking the judicial exception to a particular technological environment/field of use and applying the judicial exception with a generic computer as well as insignificant extra-solution activity of data gathering and displaying results. Additionally there is no improvement in the functioning of the computer or technological field, and there is no transformation of subject matter into a different state. Therefore, under Step 2B in a test for patent subject matter eligibility, the judicial exception of the independent claim(s) do not amount to significantly more and the independent claim(s) remain patent ineligible.
Dependent claims 2-14 further limit the abstract idea of independent claim 1. When analyzed as a whole, these claims are held to be patent ineligible under 35 U.S.C. 101 because the additional recited limitations fail to establish that the claims are not directed towards an abstract idea and do not sufficiently integrate the subject matter into a practical application or recite elements which constitute significantly more than the abstract ideas identified. The dependent claims are directed toward additional elements which encompass abstract ideas
In this instance, dependent claims recite the following limitations:
“Determine a quality associated with the first ultrasound image before identifying the first image feature within the first ultrasound image” (claim 6)
“select for each view of the plurality of views, a key image from a set of ultrasound images obtained for that view” (claim 17)
“determine whether at least one ultrasound image of the plurality of ultrasound images indicates cirrhosis” (claim 20)
The cited limitation(s), under their broadest reasonable interpretation, encompass mental processes (i.e. abstract idea) which can be performed in the mind or by a human using a pen and a paper (e.g. observation, evaluation, judgment, opinion). In other words, a human could reasonably determine a quality associated with the first ultrasound image . Examiner notes that with the exception of generic computer-implemented steps (e.g. the processor), there is nothing in the claims that preclude the limitation from being performed by a human, mentally or with pen and paper, thus the claimed limitation is considered to be directed towards a judicial exception (MPEP 2106.04(a)).
Under Step 2A, Prong II for dependent claims 2-14, present additional elements which only further narrow the judicial exceptions (e.g. claim 2 which further recites outputting to the display user guidance which amounts to merely insignificant extra-solution activity of displaying information, claims 3-5 which merely narrow the nature of the user guidance, claim 7 which further narrows the nature of the quality being based on a comparison of images, claim 8 which merely recites identifying the first image feature and obtaining further ultrasound image corresponding to the first view in its BRI is a contingent limitation and the processor must merely be capable of performing this function regardless of whether the condition has been met, thus amounts to merely insignificant extra-solution activity of data gathering, claims 9-11 which further recite a machine learning algorithm/multi-task learning model which are recited with such high generality that they amount to merely a generic computer, claim 12 which further narrows the nature of the patient anatomy and the medical condition, claim 13 which further narrow the nature of the first sub-score and the second sub-score, claim 14 which further narrows the nature of the first image feature and second image feature, claim 16 which merely further narrows the plurality of ultrasound images and the plurality of image features, claim 17 which merely further narrows the nature in which the key image is selected, claim 18 which further narrows the nature of the staging value, claim 19 which recites generating a report comprising the staging value, the plurality of ultrasound images, and the plurality of sub-scores which amounts to merely insignificant post-solution activity of data output, claim 19 which further recites outputting an indication of cirrhosis amounting to merely insignificant post-solution activity of data output) and provide no additional element which are found to integrate the judicial exception into a practical application.
These dependent claims include no additional claims that are sufficient to amount to significantly more than the judicial exception. Additionally, there is no improvement in the functioning of the computer or technological field, and there is no transformation of subject matter into a different state. As discussed above with respect to integration of the abstract idea into a practical application, the additional claims do not provide any additional elements that would amount to significantly more than the judicial exception. Under Step 2B, these claims are not patent eligible.
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 1-20 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.
Claims 1 and 15 recite the limitation “control the transducer array to obtain a plurality of ultrasound images corresponding to a plurality of views”. It is unclear if the plurality of ultrasound images and the plurality of views are the same as the plurality of ultrasound images corresponding to the plurality of views of the patient anatomy, respectively, as recited in the “output… user guidance” limitation or if these are different ultrasound images corresponding to different plurality of views. In other words, it is unclear if the transducer array is controlled to obtain images corresponding to different views that are different from those which are to be obtained from the user guidance (i.e. the guidance is ignored/wrong) or if the transducer array is controlled to obtain the same plurality of images corresponding to the same plurality of views to be obtained by the output user guidance. For examination purposes, it has been interpreted to mean the same or different plurality of ultrasound images and the same or different plurality of views, however, clarification is required.
Claim 17 recites the limitation “a key image” and “a subset of ultrasound images obtained for that view”. The limitation is unclear as to whether the key image is one of the plurality of ultrasound images, the at least one ultrasound image, or if this is a different image and the subset of ultrasound images obtained for that view is unclear as the claim does not previously set forth that images (plural) are obtained for each of the plurality of views. It is therefore unclear if the claim is attempting to set forth that ultrasound images are obtained for each view or if the claim is attempting to further define how the plurality of ultrasound images are obtained in claim 1 (e.g. via selection of a key image for each view). For examination purposes, it has been interpreted to mean any key image from any subset of images for the view which may or may not be the same as the plurality of image or the at least one image, however, clarification is required.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claims 1-5, 9-13, and 15-18 are rejected under 35 U.S.C. 103 as being unpatentable over Klochko et al. (US 20220148172 A1), hereinafter Klochko in view of Takeuchi (US 20040019270 A1), hereinafter Takeuchi or in the alternative Klochko in view of Takeuchi and Li et al. (US 20230380810 A1), hereinafter Li.
Regarding claims 1 and 15,
Klochko teaches an ultrasound system (at least fig. 2 (10) and corresponding disclosure in at least [0018]) comprising:
An ultrasound probe comprising a transducer array (at least fig. 2 (18) and corresponding disclosure in at least [0025]);
A processor (at least fig. 2 (20) and corresponding disclosure in at least [0018]) configured for communication with a display (at least fig. 2 (22b) and correspond disclosure in at least [0025]) and a transducer array of an ultrasound probe (18) (see at least fig. 2), wherein the processor is configured to:
Control the transducer array ([0025] which discloses the CPU 20 may be configured to control the provision of electrical current to the transducer probe 18 to emit sound waves, and to receive electrical pulses generated in response to soundwaves or echoes received by the transducer probe 18) to obtain a plurality of ultrasound images corresponding to a plurality of views (at least fig. 3 (102) and corresponding disclosure in at least [0051] which discloses multiple images acquired in step 102. See also [0058] which discloses if there are N number of images, step 114 comprises calculating N scores and then calculating an overall average score for the collection of N images by adding all of the individual image scores together and dividing by the number of images for which scores were calculated (i.e., N). Similarly, in an instance wherein the images acquired in step 102 are taken along multiple imaging planes (e.g., one or more images along a long axis and one or more images along a short axis), scores may be calculated for each individual image and then an average score may be calculated for each imaging plane from those individual scores (e.g., an average score of the long axis and an average score for the short axis);
Identify a plurality of image features associated with a medical condition of the patient anatomy within the plurality of ultrasound images (at least fig. 3 (110) and corresponding disclosure in at least [0041] and [0051] and [0046] which discloses the regions of interest may be identified by an electronic processor, for example, the electronic processor 12 of the system 10);
Determine a plurality of sub-scores for the plurality of image features (at least fig. 3 (114) and corresponding disclosure in at least [0052] and [0058] which discloses the evaluating step 114 may be performed for each of the acquired images such that a score is calculated for each acquired image);
Determine a staging value (at least fig. 3 (120) and corresponding disclosure in at least [0066]) representative of a progression of the medical condition based on the plurality of sub-scores ([0066] which discloses step 120 may also include assigning an indication or grade as to the severity of the condition (e.g., mild, moderate, severe). In at least some embodiments, the score calculated in step 114 may be used to assign such a grade. For example, one or more predetermined, empirically-derived thresholds or threshold ranges, each corresponding to a particular grade (e.g., mild, moderate, severe) may be stored in an electronic memory and may be used along with the calculated score to assign a grade to the medical condition and [0058] which discloses step 114 comprises calculating N scores and then calculating an overall average score for the collection of N images by adding all of the individual image scores together and dividing by the number of images for which scores were calculated (i.e., N). Similarly, in an instance wherein the images acquired in step 102 are taken along multiple imaging planes (e.g., one or more images along a long axis and one or more images along a short axis), scores may be calculated for each individual image and then an average score may be calculated for each imaging plane from those individual scores (e.g., an average score of the long axis and an average score for the short axis). The average scores for the different imaging planes may then be combined using a statistical combination (e.g., statistical mapping) to determine an overall score for the collection of acquired images. Examiner thus notes that step 120 as disclosed in [0066] is based on both the first sub-score and second sub-score. Examiner notes that either of the overall score or grade is considered a staging value in its broadest reasonable interpretation); and
Output, to the display, a screen display ([0025] which discloses the CPU 20 may also be configured to process data and generate images that are displayed on one of the user interfaces 22 and [0026] which discloses for example, one or more user interfaces 22 (user interface 22b in FIG. 2) may display images and/or other data generated by the system 10) comprising:
An indication representative of the detection of the presence or absence of the medical condition to be provided ([0067])
A visual representation of how the staging value was determined, wherein the visual representation comprises at least one ultrasound image (see at least fig. 4) of the plurality of ultrasound images and an indication of a corresponding image feature in the at least one ultrasound image (see at least fig. 4)
Klochko fails to explicitly teach the screen display comprising the staging value and the visual representation including a corresponding sub-score, however, Klochko as noted above in [0026] discloses that the user interface may display images and/or other data generated by the system 10, where examiner notes that the scores/staging value are considered data generated by the system.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date to have included in the screen display the staging value and a corresponding sub-score as part of the visual representation of how the staging value was determined in order to allow a user to visualize data corresponding to the ultrasound image(s) (e.g. the sub-scores generated thereof) for verification thereof by the user and to further allow a user to visualize the grade which was determined by the processor such that the user may evaluate the grade to provide a diagnosis/prognosis accordingly.
Klochko further fails to explicitly teach wherein the processor is configured to:
Output, to the display, user guidance to obtain a plurality of ultrasound images corresponding ot a plurality of views of a patient anatomy.
Takeuchi, in a similar field of endeavor involving ultrasound imaging, teaches wherein a processor is configured output, to a display, user guidance (at least figs. 6 and 7A (42 and 46) and corresponding disclosure in at least [0055]-[0056] and [0060]) to obtain a plurality of views of a patient anatomy (see at least fig. 5 in which the process is repeated for each of the diagnostic images to be acquired at step S13 as disclosed in [0066])
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified Klochko to include displaying user guidance as taught by Takeuchi in order to make manipulations easier and adequate for non-specialized or less experienced physicians or technicians (Takeuchi [0098]) such that a desired views of the anatomy may be acquired.
Alternatively, since Klochko fails to explicitly teach the visual representation including the ultrasound image, the identified feature, and the sub-score, it is noted that Li, in a similar field of endeavor involving ultrasound imaging, teaches a visual representation including the ultrasound image, an indication of an identified feature, and a corresponding sub-score of the ultrasound image (see at least fig. 6).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have included in the visual representation of Klochko a corresponding sub-score in order to allow a user to visualize data corresponding to the ultrasound image(s) (e.g. the sub-scores generated thereof) for verification thereof by the user. Such a modification would provide a more full-picture of the examination with respect to the ultrasound image(s) and allow a user to visually recognize all of the data associated therewith.
Regarding claim 2,
Klochko, as modified, teaches the elements of claim 1 as previously stated.
Takeuchi further teaches wherein the processor is configured to sequentially output, for each view of the plurality of views, respective user guidance to obtain at least one ultrasound image corresponding to that view (see at least fig. 5 and figs. 6-7).
Regarding claim 3,
Klochko, as modified, teaches the elements of claim 1 as previously stated. Takeuchi, as applied to claim 1 above, further teaches wherein the user guidance comprises a graphical representation of a probe and/or orientation for the ultrasound probe (see at least fig. 7A depicting both a graphical representation of a probe and an orientation for the ultrasound probe in 46).
Regarding claim 4,
Klochko, as modified, teaches the elements of claim 1 as previously stated. Takeuchi, as applied to claim 1 above, further teaches wherein the user guidance comprises a reference image (42) associated with the view of the plurality of views.
Regarding claim 5,
Klochko, as modified, teaches the elements of claim 1 as previously stated. Takeuchi, as applied to claim 1 above, further teaches wherein the user guidance comprises a description of dynamic behavior associated with a view of the plurality of views ([0049] which discloses he probe movement information 46 can be calculated from the reference position information in relation to the reference image used to acquire the following diagnosis image and the position information of the ultrasonic probe 12 currently detected by the position detector 13 and [0060] which discloses [0060] FIG. 7A is a view showing a display example of the navigation information (reference image 42 and probe movement information 46) displayed when the operator moves to the acquisition of the following diagnosis image. The ultrasonic probe movement information 46 is displayed as a view showing the relation between the ultrasonic probe 12 at the current position and the ultrasonic probe 12 at the position at which the reference image can be acquired. The probe movement information 46 shown in the drawing comprises a probe A (solid line) indicating the current position and posture of the ultrasonic probe 12, and a probe B (dotted line) indicating the position and the posture to which the ultrasonic probe 12 has to be moved. The probe B is displayed as a still image at specific position and posture so that the probe A can be moved in association with a movement of the ultrasonic probe 12 [0061] Then, the operator positions the ultrasonic probe 12 by controlling the position and the posture of the ultrasonic probe 12 so that the probe A displayed in a solid line superposes the probe B displayed in a dotted line while watching the probe movement information 46 (Step S10). Probe movement information as depicted/disclosed is considered a description of dynamic behavior (e.g. probe movement) associated with the view of the patient anatomy (i.e. to move the probe to the view of the patient anatomy))
Regarding claim 9,
Klochko further teaches wherein, to determine the plurality of sub-scores, the processor is further configured to implement a first machine learning algorithm ([0017] which discloses the systems and methods described herein are directed to artificial intelligence-driven detection of medical conditions using one or more machine learning models at one or more steps of the detection process and [0068] which discloses the evaluating step 114 and detecting step 120 may alternatively comprise using a trained machine learning model to evaluate the regions of interest identified in step 110 and to detect the presence or absence of the medical condition based thereon)
Regarding claim 10,
Klochko further teaches wherein the first machine learning algorithm comprises a multi-task learning model ([0017] which discloses the systems and methods described herein are directed to artificial intelligence-driven detection of medical conditions using one or more machine learning models at one or more steps of the detection process, where it is noted that one machine learning model applied at one or more steps of the detection process is considered a “multi-task” learning model)
Claim 11,
Klochko further teaches wherein, to identify the plurality of image features, the processor is configured to implement a second machine learning algorithm different than the first machine learning algorithm ([0046] which discloses step 110 may comprise applying a machine learning model or algorithm trained to perform image recognition to the or each of the acquired images to identify the regions of interest and the systems and methods described herein are directed to artificial intelligence-driven detection of medical conditions using one or more machine learning models at one or more steps of the detection process where one or more machine learning models indicates different machine learning algorithms and further it is noted that the different functions would use different algorithms)
Regarding claim 12,
Klochko further teaches wherein the patient anatomy comprises a liver ([0040] which discloses and wherein the medical condition comprises steatosis of the liver or other types of liver damage, the area of interest comprises an area of the patient's body that includes the patient's liver), and wherein the medical condition comprises hepatic steatosis ([0033] which discloses these medical conditions may include, for example and without limitation, one or more of: diabetes (e.g., type 2 diabetes); prediabetes; muscle atrophy/fatty infiltration (e.g., atrophy/fatty infiltration of rotator cuff muscles); and steatosis of the liver, to cite just a few examples)
Regarding claim 13,
Klochko further teaches wherein the plurality of sub-scores correspond to ultrasonographic fatty liver indicator ([0040] which discloses and wherein the medical condition comprises steatosis of the liver or other types of liver damage, the area of interest comprises an area of the patient's body that includes the patient's liver and ([0033] which discloses these medical conditions may include, for example and without limitation, one or more of: diabetes (e.g., type 2 diabetes); prediabetes; muscle atrophy/fatty infiltration (e.g., atrophy/fatty infiltration of rotator cuff muscles); and steatosis of the liver, to cite just a few examples). Therefore, in the case of steatosis which refers to a fatty liver it is noted that any scores/sub-scores correspond to ultrasonographic fatty liver indicator in its broadest reasonable interpretation)
Regarding claim 16,
Klochko further teaches wherein the plurality of ultrasound images comprises a first ultrasound image corresponding to a first view of the patient anatomy and a second ultrasound image corresponding to a second view of the patient anatomy, and
Wherein the plurality of image features comprises a first image feature within the first ultrasound image and a second image feature within the second ultrasound image.
Regarding claim 17,
Klochko, as modified, teaches the elements of claim 1 as previously stated. Klochko, as currently modified, fails to explicitly teach wherein the processor is further configured to select, for each view of the plurality of views, a key image from a set of ultrasound images obtained for that view, wherein the key image is selected based on a comparison with a reference image associated with that view.
Nonetheless, Takeuchi further teaches wherein the processor is further configured to select, for each view of the plurality of views, a key image from a set of ultrasound images obtained for that view ([0058] After the ultrasonic probe 12 is positioned, a currently pick-up image is taken therefrom as a diagnosis image according to a predetermined manipulation, and stored into the storage medium 30 (Step S8). At the same time, the position information of the ultrasonic probe 12 detected by the position detector 13 is stored in correlation with the diagnosis image. Examiner notes that such taking and storing of an image is considered to be a selection of the key image), wherein the key image is selected based on a comparison with a reference image associated with that view ([0057] which discloses the position information 44 therefore allows the operator to understand swiftly and quantitatively to what extent the ultrasonic probe 12 he is currently manipulating is displaced from the desired position (reference position information) of the ultrasonic probe 12. When disagreement between the diagnosis image and the reference image is judged in Step S6, the operator repetitively positions the ultrasonic probe 12 until agreement is judged).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified Klochko, as currently modified, to further include selecting a key image as taught by Takeuchi in order to acquire the diagnostic image for each view at a desired position making the procedure easier and adequate for non-specialized or less experienced physicians or technicians (Takeuchi [0008]).
Regarding claim 18,
Klochko further teaches wherein the staging value is based on a sum of the plurality of sub-scores ([0058] which discloses step 114 comprises calculating N scores and then calculating an overall average score for the collection of N images by adding all of the individual image scores together and dividing by the number of images for which scores were calculated (i.e., N))
Claims 6-8 are rejected under 35 U.S.C. 103 as being unpatentable over Klochko and Takeuchi, or Klochko, Takeuchi, and Li as applied to claim 1 above, and further in view of Aladahalli et al. (US 20210145411 A1), hereinafter Aladahlli.
Regarding claim 6,
Klochko, as modified, teaches the elements of claim 1 as previously stated. Klochko, as modified, fails to explicitly teach wherein the processor is further configured to determine a quality associated with the first ultrasound image before identifying the first image feature within the first ultrasound image.
Aladahalli, in a similar field of endeavor involving ultrasound imaging, teaches a processor configured to determine a quality associated with a first ultrasound image before identifying a first image feature within a first ultrasound image (at least fig. 3A (312) and corresponding disclosure in at least [0042])
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified Klochko, as currently modified, to include determining a quality as taught by Aladahlli in order ensure that the reliability to correctly identify and segment the first image feature is appropriate, such a modification provides a gate-keeper, deploying the image interpretation and analysis algorithm only when the image quality is high and the amount of turbulence is below the threshold (Aladahalli [0015])
Regarding claim 7,
Klochko, as modified, teaches the elements of claim 6 as previously stated. Aladahalli, as applied to claim 6 above, further teaches the processor is further configured to determine the quality based on a comparison between the first ultrasound image and a reference image associated with the first view of the patient anatomy ([0036] which discloses method 300 includes determining an amount of turbulence between at least two successive scan images (scan images are alternatively referred to herein as frames) for a duration of time. For example, the amount of turbulence may be calculated between the first reference image and the second subsequent image).
Regarding claim 8,
Klochko, as modified, teaches the elements of claim 6 as previously stated. Aladahalli, as applied to claim 6 above further teaches wherein the processor is further configured to:
If the quality satisfies a threshold, identify the first image feature within the first ultrasound image (at least fig. 3A (326) and corresponding disclosure in at least [0043] which discloses operating the ultrasound scanning in the static mode may include deploying the one or more desired image interpretation algorithm during scanning the acquired scan image may be used as input to the segmentation algorithm)
If the quality does not satisfy the threshold, control a transducer array to obtain a further ultrasound image corresponding to the first view of the patient anatomy (at least fig. 3A (316) and corresponding disclosure in at least [0046])
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Klochko and Takeuchi, or Klochko, Takeuchi, and Li, as applied to claim 1 above, and further in view of NPL Lin et al. (“Sonographic fatty liver, overweight and ischemic heart disease”), hereinafter Lin.
Regarding claim 14,
Klochko, as modified, teaches the elements of claim 1. Klocho fails to explicitly teach wherien the first image feature and the second feature each comprise a different one of: liver-kidney contrast, posterior attenuation, vessel blurring, gallbladder visualization, diaphragmatic attenuation visualization, or focal sparing.
Nonetheless, Lin, in a similar field of endeavor involving ultrasound evaluation, teaches wherein first and second image features comprise a different one of: liver-kidney contrast, posterior attenuation, vessel blurring, gallbladder visualization, diaphragmatic attenuation visualization, or focal sparing (pg. 4839 which discloses Severity of fatty liver was classified according to the following modified scoring system: brightness compared to kidneys (0-3), blurring of gall bladder wall (0-3), blurring of hepatic
veins (0-3), blurring of portal vein (0-3), far gain attenuation (0-3)).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified the first image feature and the second image feature to comprise a different one of: liver-kidney contrast, posterior attenuation, vessel blurring, gallbladder visualization, diaphragmatic attenuation visualization, or focal sparing as taught by Lin in order to provide an advance staging score for fatty liver. Such a modification would allow for additional scoring of the image features such as disclosed by Lin for defining severity of the fatty liver accordingly (see Lin pg. 4839 which discloses Severity was defined as mild (total scores of 2-6), moderate (7-10), and sever (11-15) fatty liver).
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Klochko and Takeuchi, or Klochko, Takeuchi, and Li, as applied to claim 1 above, and further in view of Potter et al. (US 20060034538 A1), hereinafter Potter.
Regarding 19,
Klochko, as modified, teaches the elements of claim 1 as previously stated. Klochko further teaches wherein the processor is further configured to save the plurality of ultrasound images ([0037]) and examiner notes that the processor would necessarily save (at least temporarily) the staging value and the plurality of sub-scores in order to use/display such data accordingly, however, it is not explicitly clear if the processor is further configured to generate a report comprising the staging value, the plurality of ultrasound images, and the plurality of sub-scores.
Nonetheless, Potter teaches wherein a processor is configured to generate a report comprising a plurality of ultrasound images and measurements/calculations gathered therefrom ([0073] which discloses upon pressing the complete button 104, measurements and calculations in the physician's work area are gathered together and output to the storage device 30 where the report generator 32 can access the measurements and/or calculations and create a new procedure report. Echo images may also be saved in the storage device 30 and incorporated into the procedure report. The echo images may be automatically saved and incorporated. See also [0006] which discloses The data contained in this ancillary report may be imported into a full procedural report that may include additional data including physician comments, findings, conclusions, recommendations, and diagnosis. By automating the transfer of data, including the measurements and calculations taken during and after the procedure, and the diagnosis based on the measurements and calculations, possible human error is reduced)
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified Klochko to include generating a report as taught by Potter in order to provide a record of the ultrasound images, sub-scores, and staging value calculated from the ultrasound images for later review. Such a modification would allow a user to recall the information obtained from Klochko for a specific examination of a specific patient to review the ultrasound images, the sub-scores calculated therefrom, and the staging value to provide such data to the patient or other users and/or for reviewing the accuracy of such data or for training purposes. Such a modification amounts to merely an obvious modification of recording the obtained data of Klochko into a report accordingly.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Klochko and Takeuchi, or Klochko, Takeuchi, and Li, as applied to claim 1 above, and further in view of Foreign Tanigawa (JP 2013162810 A), hereinafter Tanigawa.
Regarding claim 20,
Klochko, as modified, teaches the elements of claim 1 as previously stated. Klochko further teaches wherein the processor is further configured to determine whether at least one ultrasound image of the plurality of ultrasound images indicates steatosis or other types of liver damage ([0040] and wherein the medical condition comprises steatosis of the liver or other types of liver damage, the area of interest comprises an area of the patient's body that includes the patient's liver)
Output an indication of the steatosis or other type of liver damage to the display in response to determining that the at least one ultrasound image indicates steatosis or other types of liver damage ([0067] which discloses The signal generated in step 122 may be output to one or more components (e.g., a user interface 26 of the system 10) to provide an indication to the user as to whether or not the medical condition was detected. In an embodiment, this may comprise outputting the electrical signal to a user interface, such as, for example, a visual display or monitor to cause the user interface to display a visual indication as to whether or not the medical condition was detected in step 120).
Klochko fails to explicitly teach indicating cirrhosis.
Nonetheless, Tanigawa, in a similar field of endeavor involving ultrasound imaging, teaches wherein a processor is configured to determine whether at least one ultrasound image indicates Cirrhosis ([0036] which discloses the determination unit determines whether or not the liver is cirrhotic based on the multifractal analysis result X2. And [0023] which discloses the region of interest R set in the ultrasound image UG is a region to be subjected to multifractal analysis described later and [0026]. Thus determines whether at least one ultrasound image indicates Cirrhosis by evaluating the multifractal analysis result of said at least one ultrasound image)
Output an indication of the Cirrhosis to the display in response to determining that the at least one ultrasound image indicates Cirrhosis ([0039] which discloses When it is determined that the liver is cirrhotic, as shown in FIG.7, the display control unit 5 causes the display unit 6 to display a message M2 indicating that the liver is suspected to be cirrhotic together with the ultrasound image UG.)
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified Klochko to include determining whether at least one ultrasound image indicates Cirrhosis and outputting an indication of the cirrhosis in order to provide additional diagnostic evaluations to a patient for example in a case where the liver is suspected to be cirrhotic as opposed to being fatty. Such a modification would allow diagnosis of additional liver diseases as suggested by Klochko in [0040].
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BROOKE L KLEIN whose telephone number is (571)270-5204. The examiner can normally be reached Mon-Fri 7:30-4.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anne Kozak can be reached at 571-270-0552. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/BROOKE LYN KLEIN/Primary Examiner, Art Unit 3797
Prosecution Insights