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
Regarding 35 U.S.C. 101
Applicant's arguments filed 09/30/2025 have been fully considered but they are not persuasive.
For example, applicant argues “the rejections variously assert that the independent claims recite combinations of features that do not ‘preclude the limitation from being performed by a human, mentally or with pen and paper’. This is incorrect, and there is nothing in the record other than these incorrect conclusory assertions that shows the combination of features in the independent claims can be performed by a human, mentally or with pen and paper” (REMARKS pg. 7). Examiner respectfully disagrees in that the record clearly identifies elements of the claims which can be performed by a human, mentally or with pen and paper (i.e. quantifying, comparing, and identifying) with reasoning as to how a person could look at an ultrasound frame and perform these steps (see the previous OA and rejection maintained below for more detail). Applicant’s arguments are considered merely conclusory without providing any evidence/arguments as to why the cited elements are not capable of being performed by a human, mentally or with pen and paper and it is noted that applicant’s arguments cannot replace evidence where evidence is necessary.
Applicant further argues “the rejections do not anywhere identify an abstract idea or even a category of Abstract Ideas taught to Examiners in the training materials for patent eligibility. Rather the rejections characterize some, but not all of the claim limitations of claim as being performable in the human mind or by pen and paper under Step 2A, prong 1. This is not identification of an Abstract Idea or even a category of Abstract Ideas. An example of an Abstract Idea from the well-known Electric Power group case is gathering and analyzing information of a specified content, then displaying the results’. There is no such characterization in the rejections” (REMARKS pg. 7-8). Examiner respectfully disagrees in that MPEP 2106 sets forth explicitly the enumerated groupings of abstract ideas are defined as 1) Mathematical concepts, 2) Certain methods of organizing human activity and 3) Mental Processes- concepts performed in the human mind (including an observation, evaluation, judgment, opinion) and further sets forth that the courts do not distinguish between mental processes that are performed entirely in the human mind and mental processes that require a human to use a physical aid (e.g., pen and paper or a slide rule) to perform the claim limitation. Thus applicant’s arguments that the rejection characterizes some of the limitations as being performable in the human mind or by pen and paper thus clearly describes that the rejection identifies an abstract idea and specifically the category of abstract ideas defined by the MPEP as Mental Processes. Furthermore, regarding applicant’s arguments that the claims are not characterized in the same manner as “Electric Power Group” case, it is noted the Electric Power Group case is merely exemplary of claims that recite mental processes and the instant application is examined on its own merits and is not required to be identical to such exemplary cases. Applicant’s arguments are considered merely conclusory without specifically explaining why the limitations (e.g. quantifying.., comparing.., and identifying…) cited by examiner as being abstract ideas are not considered mental processes as described by the MPEP. For at least these reasons, applicant’s arguments are not found persuasive.
Applicant further argues “the combined features leading up to and including ‘identifying thickening in the pleural line based on comparing the quantification of the plural line to the predetermined value’ cannot practically be performed in the human mind. The inability to practically perform these features in the human mind is described in the background of the instant application, and exemplified by the absence of these types of features being performed in the human mind in any of the documents cited in the art rejections” (REMARKS pg. 8). Examiner respectfully disagrees in that the claim limitations as currently recited are broadly recited and are not precluded from being performable in the human mind. Furthermore, regarding the background of the invention, it is noted that the background merely describes that the evaluation of pleural line changes in lung ultrasound is subjective, however, does not reasonably state nor suggest that the claimed features of quantifying the plural line, comparing the quantification and identifying thickening as recited by the claims cannot be performed in the human mind or with the aid of pen and paper. Applicant’s arguments are thus considered merely conclusory without providing specific evidence/arguments as to why the cited features cannot be performed in the mind. Furthermore, it is noted that the absence of features being performed in the human mind by the cited art is not a factor to be considered when examining under 101. First it is noted that prior art and 101 evaluations are different and considered on their own merits and further it is noted that the prior art using a computer/processor to perform such recited limitations does not mean that the elements are not practically performed in the mind.
Regarding applicant’s arguments on pg. 8 that “none of the claims specified in the MPEP to recite a mental process are analogous to the pending claims” with specific mention of Electric Power Group, University of Utah Research Foundation v. Ambry Genetics and “Classen Immunotherapies, Inc. v. Biogen IDEC”. As noted previously, the application is examined on its own merits and the cited cases are merely exemplary of mental processes but mental processes are not limited by such examples.
For at least the reasons listed above, applicant’s arguments are not found persuasive.
Applicant further argues “support for eligibility of the claims such as those in the instant application can be found in, for example, the two following precedential judicial opinions” citing to SRI International, Inc, v. Cisco Systems, Inc. and Packet Intelligence, Inc. v. Netscout Systems Texas which were confirmed as not involving any abstract idea and further argues that the cited features in the pending claims “require the types of granular data processing required in these cases” (REMARKS pg. 9-10). Examiner respectfully disagrees in that applicant’s arguments are merely conclusory without providing specific evidence/arguments as to how the instant claim limitations “require the types of granular data processing required” in the cited cases. Applicant’s arguments do not replace evidence where evidence is necessary. It is noted that although the cited cases are identified as not being directed to abstract ideas, the reasons identified by the courts are not relatable to the instant claims and applicant has not specifically pointed to the ‘types of granular data processing’ that are required for the precedential cases that relate to the instant application. More specifically of the precedential cases cited by applicant are directed to packet-level security monitoring having specific features and processing techniques which lead to solving technological problems arising in computer networks, where such specific features/processing techniques do not relate to nor are recited in the instant claims. In other words, there is no nexus between such a specific techniques/elements recited by the claims of these cited cases and the instant claims. For at least these reasons, applicant’s arguments are not found persuasive.
Applicant’s arguments that “even if one or more abstract idea were properly identified, a key question that must then be answered is to whether the claims recite specific features as to how the abstract idea is performed or otherwise achieved, and especially in a way that provides a technology solution to a technology problem. And points to specific decisions form the Cour of Appeals for the Federal Circuit, concluding that “the claims provide multiple technical solutions to multiple technical problems described in the Background. In this regard, the technical solutions that enable detection of changes in the pleural line, are only possible using particular types of technologies in order to provide objective assessments that are automated, standardized, and understandable to users. There is nothing analogous to anything found as ineligible in a precedent or in the 2019 Subject Matter Eligibility Update or subsequent guidance (including examples) published by the U.S. Patent and Trademark Office, as set forth above” (REMARKS pg. 10-12). Examiner respectfully disagrees in that the claims are broadly recited without providing any specificity as to how the recited steps are performed such that they cannot be performed in the mind by human or pen and paper and further are broadly recited such that there is no nexus between the recited elements and the supposed improvement described in the background. In other words, the claims do not recite any specificity such that quantifying…comparing… and identifying… as recited by the claims lead to the supposed improvement of objective assessments that are automated, standardized, and understandable to users. Furthermore, it is noted that the judicial exception alone cannot provide the improvement (see MPEP 2106.05(a)). Thus applicant’s arguments do not specifically describe how the claims as a whole (e.g. including additional elements) leads to the supposed improvement. In other words, applicant’s arguments are considered merely conclusory without providing specific evidence/arguments as to why the claim as a whole leads to the cited improvement. For at least these reasons, applicant’s arguments are not found persuasive.
Finally, applicant’s argues “HALMANN cited in the art rejections was issued as a patent by an adjacent art unit in 2023, and the cited publication has claims similar but not identical to the claims presented originally in the instant application” (REMARKS pg. 12). As noted multiple times above, the instant application is examined on its own merits, thus the patentability of Halmann having similar limitations is not considered for eligibility of the current application.
For all of the reasons listed above, applicant’s arguments are not found persuasive and 101 rejection is maintained/updated in light of the amendments.
Regarding 35 U.S.C. 112
Examiner notes that the 112(b) rejections of claims 5-6, 10, 13, and 18-19 are withdrawn in view of the amendments to the claims.
Applicant's arguments filed 09/30/2025 regarding claims 7 and 8 have been fully considered but they are not persuasive.
For example, applicant argues “it could not be clearer from claim 7 that the calculating in claim 7 is part of the quantifying in claim 1. This is so due to the language of ‘the quantifying further comprises’ in claim 7. There is seemingly no way to write the claim more clearly, and if the examiner’s believes there is, the examiner is requested to suggest revisions” (REMARKS pg. 13). Examiner respectfully disagrees in that applicant appears to misunderstand the nature of the rejection. For example, applicant’s arguments cite that the calculating is part of the quantifying, however, the previously set forth rejection identifies that it is unclear whether the metrics are the same as the quantification. In other words, claim 1 sets forth quantifying the pleural line… to obtain a quantification and claim 7 sets forth “quantifying further comprises calculating a plurality of pleural line metrics”, thus the claim does not clearly distinguish nor tie together the quantification which is to be obtained and the plurality of pleural line metrics, therefore, it is unclear if the claim is setting forth different/distinct elements or if the claim is attempting to further define the quantification to be, include, or be included in the plurality of pleural line metrics, or if the plurality of pleural line metrics are used to obtain a different but related quantification. If applicant intends for the plurality of pleural line metrics to be the same as the quantification, it is recommended to remove “further” and recite that the quantification is or includes a plurality of pleural line metrics, however, if this is a separate/distinct element it is recommended to amend the claims to clearly differentiate the two and provide corresponding support in the specification for such an amendment.
Applicant further argues “it could not be clearer from claim 8 that the comparing in claim 8 is part of the comparing in claim 1. This is due to the language of ‘the comparing further comprises; in claim 8. This means that the predetermined value in claim 1 comprises corresponding predetermined value for each of the plurality of pleural lines in claim 8. There is seemingly no way to write the claim more clearly, and if the Examiner believes there is, the Examiner is requested to suggest revisions” (REMARKS pg. 14). Examiner respectfully disagrees in that while the comparing is recited as further comprising such elements, thus making it clear that the elements of claim 8 are included in the comparing of claim 1, such a limitation of “further comprising” makes it appear as though this is a different step included in the comparing. Furthermore, since the plurality of pleural line metrics are not clearly tied to the quantification of claim 1, it is not explicitly clear that comparing the quantification and comparing the plurality of pleural line metrics are the same such that a person would recognize the predetermined value that characterizes a normal, healthy pleural line as being the same as or included in the corresponding predetermined value. Since this appears to be applicant’s intention, it is recommended to clearly tie the quantification to pleural line metrics and further define that the predetermined value is or is included in a plurality of predetermined values corresponding to the plurality of pleural line metrics or similar.
For at least the reasons listed above, applicant’s arguments with respect to claims 7-8 are not found persuasive.
Regarding prior art
Applicant’s arguments with respect to the claims have been considered but are moot in view of the new grounds of rejection necessitated by amendment.
Examiner notes that Halmann alone is not relied upon for teaching the features of the independent claims and Seghal as previously relied upon for claims 6 and 20 is relied upon to teach aspects related to identifying the thickening in view of the amendments to the independent claims. While applicant appears to traverse the rejections of claims 6 and 20, there is no such arguments presented for consideration which are specific to the teachings of Halmann in view of Seghal.
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 1-4, 6-18, and 20-21 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, 11, and 14 are found to recite a judicial exception (i.e. abstract idea). In this instance, claims 1 and 11 recite the limitations “obtain/obtaining an ultrasound frame of a lung and identify/identifying a pleural line in the lung”, “quantify/quantifying the pleural line identified in the lung to obtain a quantification of the pleural line”, “compare/comparing the quantification of the pleural line to a predetermined value (that characterizes a normal, healthy pleural line claim 1)”, “identify/identifying a thickening in the pleural line based on comparing the quantification of the pleural line to the predetermined value”. The cited limitations, under their broadest reasonable interpretation, encompass a mental process (i.e. abstract idea) of obtaining, quantifying, comparing, and identifying 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 obtain an ultrasound frame by observation (e.g. by looking at an ultrasound image/frame), identify a pleural line by observation/evaluation, quantify the pleural line by observation evaluation of the pleural line (where quantification is broadly recited and encompasses merely determining the shape, size, texture, position, location, etc. see at least [0048]-[0049] of applicant’s specification), compare the quantification to a predetermined value by observation/evaluation/judgment, and identify a thickening in the pleural line by observation/evaluation. Examiner notes that with the exception of generic computer-implemented steps (e.g. an ultrasound controller recited in claim 11 and a computer apparatus in claim 14), there is nothing in the claims that preclude the limitations 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):
Obtain/obtaining an ultrasound frame of a lung (claims 1, 11, and 14)
An ultrasound controller comprising a memory that stores instructions and a processor that executes the instructions (claim 11)
A tangible non-transitory computer readable storage medium (claim 14)
The additional elements in the cited independent claims are not found to integrate the judicial exception into a practical application. In this case, obtain/obtaining an ultrasound frame of a lung is alternatively considered an additional element which amounts to merely insignificant extra-solution activity of data gathering where the data is an ultrasound frame of a lung which is considered to merely link the judicial exception to a field of use (i.e. ultrasound imaging of a lung), an ultrasound controller and non-transitory computer readable storage medium are found to merely be generic components of an ultrasound system and/or amount to merely performing/applying the judicial exception on a generic computer or in a computer environment. These elements are seen as adding insignificant extra-solution activity to the judicial exception. They do no more than link the judicial exception to a particular technological environment or field of use. Therefore, under step 2A Prong II the judicial exception is not integrated into a practical application by additional elements of independent claims 1, 11, and 14 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 element(s) listed above do not amount to significantly more than the judicial exception. In this instance, as noted above the additional elements amount to merely insignificant extra-solution activity of data gathering in the field of ultrasound lung imaging and applying the judicial exception with a generic computer. 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 2-4, 6-10, 12-13, 15-18, and 20-21 further limit the abstract idea of independent claims 1, 11, and 14. 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:
Determining a degree of the thickening in the pleural line based on the quantification of the pleural line (claims 2 and 15)
Quantifying the thickening identified in the pleural line (claims 6 and 20)
Calculating a plurality of pleural line metrics (claim 7)
Comparing each of the plurality of pleural line metrics to a corresponding predetermined value (claim 8)
Detecting ultrasound imaging of the lung (claim 9)
Aggregating the quantification of the pleural line identified in the lung from the ultrasound frame with another quantification of the pleural line identified in the lung from another ultrasound frame to obtain an aggregated quantification of the pleural line (claim 10)
Identifying the thickening in the pleural line based on comparing the aggregated quantification of the pleural line to the predetermined value (claim 10)
determine a severity level associated with the pleural line, determine a pleural line as being either normal or abnormal, determine based on quantifying the pleural line an assessment of an overall condition of the lung, or determine based on quantifying the pleural line a likelihood of one or more pathological conditions (claim 21)
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 degree of the thickening by observation/evaluation, calculate a plurality of pleural line metrics by observation/evaluation, compare each of the plurality of pleural line metrics to a corresponding predetermined value by observation/evaluation, detect ultrasound imaging of the lung by observation/evaluation, aggregate quantifications from different images by observation/evaluation, identify the thickening in the plural line based on comparing by observation/evaluation, determine a degree of the thickness based on metrics of the image features by observation/evaluation, and determine a severity level, a pleural line as normal or abnormal, determine an assessment of an overall condition, or determine a likelihood of one or more pathological conditions by observation/evaluation. Examiner notes that with the exception of generic computer-implemented steps (e.g. a processor/computer apparatus) 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 dependent claims 2-10, 12-13, and 15-21 present additional elements which only further narrow the judicial exceptions (e.g. claims 2-3, 12, and 16-17 which further recite outputting an indication which amounts to merely insignificant extra-solution activity of outputting data/results and further recite data superimposed on an ultrasound frame on a display which amounts to merely displaying data/result on a generic component of and ultrasound system (i.e. a display), claim 9 which merely recites automatically executing a software program to perform the method of claim 1 which amounts to merely applying the judicial exception on a generic computer, claims 13 and 18 which merely recite applying a trained artificial intelligence model to the quantification which amounts to merely applying a generic computer) 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 5-8, 10, 13, and 18-19 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 7 recites the limitation “calculating a plurality of pleural line metrics”. It is unclear if the plurality of pleural line metrics are the same as or included in the “quantification” of claim 1, if the plurality of metrics are used in determining the quantification or if these are different/distinct elements than the quantification of claim 1. For examination purposes, it has been interpreted to mean any plurality of line metrics which may be included in, the same as, or different from the quantification, however, clarification is required.
Claim 8 recites the limitation “comparing each of the plurality of pleural line metrics to a corresponding predetermined value”. It is unclear if the corresponding predetermined value is or includes the predetermined value recited previously or if this is a different/distinct corresponding predetermined value. For examination purposes, it has been interpreted to mean any corresponding predetermined value, 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 1-4, 6-9, 11-18 and 20-21 are rejected under 35 U.S.C. 103 as being unpatentable over Halmann et al. (US 20220061813 A1), hereinafter Halmann in view of Sehgal et al. (US 20230090858 A1), hereinafter Sehgal.
Regarding claims 1, 11, and 14,
Halmann teaches a system (at least fig. 2 (200) and corresponding disclosure in at least [0030]) for processing an ultrasound frame, comprising:
An ultrasound controller (at least fig. 2 (231) and corresponding disclosure in at least [0030]) comprising a memory (at least fig. 2 (206) and corresponding disclosure in at least [0031] “non-transitory memory 206”) that stores instructions ([0031] which discloses instructions stored in non-transitory memory 206) and a processor (at least fig. 2 (204) and corresponding disclosure in at least [0031]) that executes the instructions ([0031] which discloses processor 204 configured to execute the instructions stored in memory 206), wherein when executed by the processor, the instructions cause the ultrasound controller to:
Obtain an ultrasound frame of a lung ([0033] which discloses the medical image data 214 includes lung ultrasound data and [0035] which discloses the medical image data may include ultrasound images such as lung ultrasound images [0032] which discloses the detection and quantification module 212 includes one or more algorithms to process input medical images from the medical image data 214, thus the input medical images from the medial image data 214 are obtained. See also fig. 3 (304-306) and corresponding disclosure in at least [0045]-[0046]) and identify a pleural line in the lung (at least fig. 3 (308) and corresponding disclosure in at least [0047]);
Quantify the pleural line identified in the lung to obtain a quantification of the pleural line (at least fig. 3 (310) and corresponding disclosure in at least [0049] and [0051] which discloses the processor may evaluate each pixel of the pleural line to determine a jumpiness score and a dimness score and [0052] which discloses an irregularity score is generated as a product of the jumpiness score and the dimness score, where such generation/determination of scores constitutes quantifying the pleural line to obtain a quantification (i.e. score) of the pleural line);
Compare the quantification of the pleural line to a predetermined value that characterizes a normal, healthy pleural line ([0052] which discloses an irregularity score may be compared to a threshold which may be a pre-determined value that distinguishes irregular pleura associated with a disease state from normal, healthy pleura (thus the predetermined value characterizes a normal, healthy pleural line)); and
Identify at least one of irregularity or thickening in the pleural line based on comparing the quantification of the pleural line to the predetermined value ([0052] which discloses if the irregularity score is greater than or equal to the threshold score, the pleura imaged in that pixel location may be considered irregular. As a result, an area of pixels having pre-determined dimensions may be grouped and identified as a location of irregularity (e.g., irregular pleura) responsive to a majority (e.g., greater than 50%) of the pixels within the group being characterized as irregular pleura)
Halmann fails to explicitly teach wherein the instructions cause the ultrasound controller to identify thickening in the pleural line based on the comparing the quantification of the pleural line to the predetermined value.
Sehgal, in a similar field of endeavor involving ultrasound lung imaging, teaches an ultrasound controller configured to: identify thickening in a pleural line based on comparing a quantification of a pleural line to a predetermined value ([0020] which discloses following the detection of the pleural line (p-line), a computing device may extract a variety of features, such as morphological features, quantitative features describing thickness (thus quantifying the pleural line). The thickness parameters may measure the nonuniform widening of the pleural line and [0046] thickness of p-lines was larger in COVID-19 cases (6.27±1.45 mm) compared to normal (1.00±0.19 mm), P<0.001 and [0062] which discloses the thickness of p-lines was larger on average in COVID-19 cases (6.27±1.45 mm) compared to normal (1.00±0.19 mm), P<0.001. P-line thickness variation was also larger on average in COVID-19 cases, 2.86±0.64 mm compared to 0.26±0.07 mm, P<0.001. see also [0083] which discloses fig. 7A shows an example of a COVID-19 confirmed case showing pleural thickening and irregularity with the presence of focal B-lines. Quantitative pleural line features detected the case accurately as COVID-19)
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified Halmann to include identifying thickness as taught by Sehgal in order to provide additional diagnostic data related to the pleural line thereby enhancing the diagnosis of the patient, especially in a case where the patient experiences pneumonia due to COVID-19 (see Halmann [0062]).
Examiner notes that the modified system would perform the method of claim 1 and comprise the tangible non-transitory computer readable storage medium of claim 14 each having corresponding method steps/processor functions.
Examiner notes that the identifying thickening would be based on comparing the quantification taught by Sehgal and further based on the comparing of the quantification of Hallman due to the broadest reasonable interpretation of “based on”.
Regarding claims 2 and 15,
Halmann, as modified, teaches the elements of claims 1 and 14 as previously stated. Sehgal, as applied to claims 1 and 14 above, further teaches wherein the ultrasound controller is caused to:
Determine a degree of the thickening in the pleural line based on the quantification of the pleural line ([0046] thickness of p-lines was larger in COVID-19 cases (6.27±1.45 mm) compared to normal (1.00±0.19 mm), P<0.001 and [0062] which discloses the thickness of p-lines was larger on average in COVID-19 cases (6.27±1.45 mm) compared to normal (1.00±0.19 mm), P<0.001. P-line thickness variation was also larger on average in COVID-19 cases, 2.86±0.64 mm compared to 0.26±0.07 mm, P<0.001) where such a thickness evaluation compared to normal is considered a degree of thickening).
Regarding claims 3 and 16,
Halmann further discloses wherein the computer program, when executed by a processor, causes the computer apparatus further to:
output an indication (at least fig. 4 (406) and corresponding disclosure in at least [0054]) of the irregularity in the pleural line (at least fig. 3 (314/316) and corresponding disclosure in at least [0053]).
Hallmann, as currently modified, fails to explicitly teach outputting an indication of the thickness in the pleural line.
Nonetheless, Sehgal further teaches outputting an indication of the thickening of the pleural line ([0092] which discloses outputting an indication of the conditions (i.e. indication of a disease) and [0066] which discloses The statistically significant features included the thickness, thickness variation (TV), projected intensity deviation (PID), nonlinearity, tortuosity, and heterogeneity. Any one or combination of these features may be used to identify a condition of a subject, thus it is noted that outputting an indication of a condition (i.e. disease) is considered an indication of the thickening of the pleural line see also at least fig. 1A showing a confirmed COVI-19 case with plural thickening and irregularity and the right side depicting an outlined plueral line which is detected with a semi-automated segmentation as disclosed in [0060]).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified Halmann, as currently modified to include outputting an indication of the thickening of the pleural line as taught by Sehgal in order to allow for enhanced understanding of the diagnosis of the patient and visualization of the pleural line. Such a modification would thereby enhance the diagnostic procedure by outputting an indication of the disease and further allowing a user to easily visualize the pleural line segmentation for visual confirmation of the thickening/irregularity.
Regarding claims 4 and 17,
Halmann further discloses wherein the indication (406) is output as data superimposed on the ultrasound frame on a display (see at least fig. 4 and corresponding disclosure in at least [0054] where the markers 406 are superimposed on the ultrasound image frame 402)
Sehgal, as applied to claims 3 and 16 above, further teaches wherein the indication is output as data superimposed on the ultrasound frame on a display (see at least fig. 1A right panel and [0060] which discloses a pleural line detected with semiautomated segmentation in a confirmed COVID-19 case).
Regarding claims 6 and 20,
Halmann, as modified, teaches the elements of claims 1 and 14 as previously stated. Sehgal, as applied to claims 1 and 14, further teaches quantifying the thickening identified in the pleural line, wherein the thickening comprises at least one measure of a width of the pleural line, thickness of a segmentation of the pleural line, or area of the segmentation of the pleural line ([0020] which discloses following the detection of the pleural line (p-line), a computing device may extract a variety of features, such as morphological features, quantitative features describing thickness (thus quantifying the pleural line). The thickness parameters may measure the nonuniform widening of the pleural line and [0046] thickness of p-lines was larger in COVID-19 cases (6.27±1.45 mm) compared to normal (1.00±0.19 mm), P<0.001 and [0062] which discloses the thickness of p-lines was larger on average in COVID-19 cases (6.27±1.45 mm) compared to normal (1.00±0.19 mm), P<0.001. P-line thickness variation was also larger on average in COVID-19 cases, 2.86±0.64 mm compared to 0.26±0.07 mm, P<0.001. see also [0083] which discloses fig. 7A shows an example of a COVID-19 confirmed case showing pleural thickening and irregularity with the presence of focal B-lines. Quantitative pleural line features detected the case accurately as COVID-19).
Regarding claim 7,
Halmann further discloses wherein the quantifying further comprises:
Calculating a plurality of pleural line metrics (at least fig. 3 (310 and 318) and corresponding disclosure in at least [0049]-[0052] and [0058]-[0059] where the irregularity score is considered a pleural line metric and is calculated for each acquisition until the acquisition is finished at 318. additionally/alternatively [0051] which discloses the processor may evaluate each pixel of the pleural line to determine a jumpiness score and a dimness score for each pleural location in order to identify positions of pleural irregularities where the jumpiness score and dimness score are considered to be metrics).
Additionally/alternatively Sehgal additionally teaches calculating a plurality of pleural line metrics ([0031] which discloses engineered features a-g may be used to quantify the morphology and physical characteristics of pleural lines including thickness and thickness variation. [0046])
Regarding claim 8,
Halmann further discloses wherein the comparing further comprises: comparing each of the plurality of pleural line metrics to a corresponding predetermined value ([0052] which discloses the irregularity score is compared to a threshold. Examiner notes that each of the plurality of irregularity scores (i.e. for each acquisition) is therefore compared to a threshold (i.e. a corresponding predetermined value).
Additionally/alternatively Seghal further teaches comparing each of the plurality of pleural line metrics to a corresponding predetermined value ([0046] which discloses results: Six of 7 p-line features showed a significant difference between normal and COVID-19 cases. Thickness of p-lines was larger in COVID-19 cases (6.27±1.45 mm) compared to normal (1.00±0.19 mm), P<0.001. Among features describing p-line margin morphology, projected intensity deviation showed the largest difference between COVID-19 cases (4.08±0.32) and normal (0.43±0.06), P<0.001. From the echo-line features, only 2 features, gray-level non-uniformity and run-length non-uniformity, showed a significant difference between normal cases (0.32±0.06, 0.59±0.06) and COVID-19 (0.22±0.02, 0.39±0.05), P=0.04, respectively)
Regarding claim 9,
Halmann further discloses further comprising:
Detecting ultrasound imaging of the lung ([0043] which discloses an operator may select the lung protocol from a plurality of possible ultrasound protocols or alternatively the system may automatically select the lung ultrasound protocol. Examiner notes that in selecting the lung ultrasound protocol a detection of ultrasound imaging of the lung is necessarily performed in the method. In other words, the method would detect that ultrasound image of the lung is performed/to be performed)
Automatically executing a software program to perform the method of claim 1 based on detecting the ultrasound imaging of the lung ([0045] which discloses the lung ultrasound protocol may include instructions for the ultrasound system to automatically acquire some or all of the data and perform other functions. Examiner notes that the lung ultrasound protocol is considered a software program that is execute to perform the method of claim 1 (i.e. the method steps of fig. 3) (see [0058] in which the lung ultrasound protocol is ended at step 318))
Regarding claim 12,
Halmann further discloses further comprising:
A display (at least fig. 2 (233) and corresponding disclosure in at least [0030]) that displays an indication (at least fig. 4 (406) and corresponding disclosure in at least [0054]) of the irregularity in the pleural line.
Hallmann, as currently modified, fails to explicitly teach wherein the indication is an indication of the thickening in the pleural line.
Nonetheless, Sehgal further teaches displaying an indication of the thickening of the pleural line (see also at least fig. 1A showing a confirmed COVI-19 case with plural thickening and irregularity and the right side depicting an outlined plueral line which is detected with a semi-automated segmentation as disclosed in [0060]).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified Halmann, as currently modified to include outputting an indication of the thickening of the pleural line as taught by Sehgal in order to allow for enhanced understanding of the diagnosis of the patient and visualization of the pleural line. Such a modification would thereby enhance the diagnostic procedure by outputting an indication of the disease and further allowing a user to easily visualize the pleural line segmentation for visual confirmation of the thickening/irregularity.
Regarding claims 13 and 18,
Halmann further discloses wherein the computer program, when executed by the processor, further causes the computer apparatus to: apply a trained artificial intelligence model to the quantification of the pleural line to compare the quantification of the pleural line to the predetermined value and to identify the thickening ([0032] which discloses for example, the detection and quantification module 212 may include trained and/or untrained neural networks and may further include training routines, or parameters (e.g., weights and biases), associated with one or more neural network models stored therein and [0034] which discloses optionally, the image processor 231 may be communicatively coupled to a training module 210, which includes instructions for training one or more of the machine learning models stored in the detection and quantification module 212. The training module 210 may include instructions that, when executed by a processor, cause the processor to build a model (e.g., a mathematical model) based on sample data to make predictions or decisions regarding the detection and classification of anatomical irregularities without the explicit programming of a conventional algorithm that does not utilize machine learning. Examiner notes that such use of a trained artificial intelligence model constitutes applying the trained artificial intelligence model to any data produced by the detection and quantification module (thus the quantification of the pleural line) where to compare the quantification of the pleural line to the predetermined value and to identify the thickening are considered an intended use of such application of the trained artificial intelligence model and it is noted that applying the trained artificial intelligence model is capable of being used to compare the quantification of the pleural line and to identify the thickening).
Additionally/alternatively Sehgal further teaches applying a trained artificial intelligence model to the quantification of the pleural line to compare the quantification of the pleural line to the predetermined value and to identify the thickening ([0092] which discloses Additionally, the computing device may be configured to implement a machine learning model configured to recognize features of pleural lines, categorize images based on imaging features (e.g., pleural lines, morphology of pleural lines), and/or the like and [0107] which discloses the computing device may analyze the pleural line regions using a model, rules, a machine learning model, and/or the like. Examiner notes that to compare the quantification of the pleural line to the predetermined value and to identify the thickening are considered an intended use of such application of the trained artificial intelligence model and it is noted that applying the trained artificial intelligence model is capable of being used to compare the quantification of the pleural line and to identify the thickening)).
Regarding claim 21,
Halmann further teaches wherein the computer program, when executed by the processor, further causes the computer apparatus to: determine a pleural line as being abnormal, determine based on quantifying the pleural line an assessment of an overall condition of the lung, or determine based on quantifying the pleural line a likelihood of one or more pathological conditions ([0062] which discloses method 300 includes outputting a suggested diagnosis to the display. AS one example, the presence of B-lines and consolidation may indicate an accumulation of fluid, such as due to bacterial or viral pneumonia. Further, the processor may take into account a spread pattern of the irregularities among rib spaces (e.g., concentrated in a few spots or spread across the lungs). As another example, a lack of pleural sliding may indicate a collapsed lung. As such, the processor may compare the annotated ultrasound image having the highest score to a plurality of models corresponding to healthy lung or disease states and select the model having the best fit to output as the suggested diagnosis. The suggested diagnosis may be output as a text-based message alongside or overlapping the displayed highest scoring annotated image. As one example, when the best fit model is pneumonia, the message may read, “Consider pneumonia.” In addition to or as an alternative to the suggested diagnosis, the processor may output suggestions on findings, such as irregular pleura, a sub-pleural consolidation, and the like)
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Halmann and Sehgal, as applied to claim 1 above, and further in view of Arntfield et al. (US 20230148996 A1), hereinafter Arntfield.
Regarding claim 10,
Halmann teaches the elements of claim 1 as previously stated. Halmann fails to explicitly teach further comprising:
Aggregating the quantification of the pleural line identified in the lung from the ultrasound frame with another quantification of the pleural line identified in the lung from another ultrasound frame to obtain an aggregated quantification of the pleural line, and
Identifying the thickening in the pleural line based on comparing the aggregated quantification of the pleural line to the predetermined value.
In a similar field of endeavor involving ultrasound lung imaging, teaches aggregating a quantification from an ultrasound frame and a quantification from another ultrasound frame to obtain an aggregated quantification ([0127] which discloses if individual images are processed separately at 1135, the aggregated outputs for the encounter may be averaged or otherwise combined to generate a combined output for the encounter and [0130] At 1135, an output tensor can be generated using an output neural network. In some cases, the output neural network is a 3-layer fully connected network with softmax activation. [0131] The output tensor may represent a probability of the presence of a first condition of the plurality of conditions in the at least one ultrasound image).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified Halmann to include aggregating the quantification from the ultrasound frame with a quantification from another ultrasound frame to obtain an aggregated quantification as taught by Arntfield in order to enhance the accuracy of the quantification. A person having ordinary skill in the art would have recognized the benefit of averaging data analysis output across multiple images to improve the accuracy of the quantification obtained from said images.
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified Halmann, as currently modified, to compare the aggregated quantification to the predetermined value of Halmann, as currently modified, (e.g. the predetermined value of