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 .
Status of Claims
This action is in reply to the application filed on February 7, 2024.
Claim(s) 1-29 are currently pending and have been examined.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: communication unit and controller in claims 23-27.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
The following is a quotation of the second paragraph of 35 U.S.C. 112:
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 23-27 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 pre-AIA the applicant regards as the invention. In particular it is not clear what a controller or communication unit is. See specification page 50 || 22-26: The system configured to carry out a method according to the second group of embodiments of the method comprises a communication unit, a controller and a user interface. Also see specification page 51 || 14-16; The controller is configured for determining in an automated or semi-automated manner and for each identified abnormality a position information indicating the position of the identified abnormality in the current presentation.
Examiner interprets said controller and communication unit as part of a computing system software/program within a computer. Appropriate clarification and correction are required.
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 1-29 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more. Based upon consideration of all of the relevant factors with respect to the claims as a whole, the claims are directed to non-statutory subject matter which do not include additional elements that are sufficient to amount to significantly more than the judicial exception because of the following analysis:
Independent Claim(s) 1, 23, 28 and 29 are directed to an abstract idea consisting of a system comprising systems for calculating an edible score, including retrieve, a performance profile relating to a user; determine, an edible of interest; receive, nourishment information relating to the edible of interest; generate, an output an edible score; and display, the edible score.
Independent Claims recite “screening a virtual current presentation of a current study of the body portion for the abnormality (2); identifying separate abnormalities in the current presentation; determining, for each identified abnormality, a position information indicating the position of the identified abnormality in the current presentation, wherein the step (S3) of determining is an automated or semi-automated step; generating a table (4) listing the identified abnormalities (2) and, for each listed abnormality, a position information indicating the position of the abnormality in the body portion; providing the table to a user (3).”
The limitations of Claims 1, 23, 28 and 29, as drafted, under its broadest reasonable interpretation, covers the performance of a Mental Process which are concepts performed in the human mind (including an observation, evaluation, judgment, opinion), but for the recitation of generic computer components. That is, other than reciting, “communication unit, controller, user interface, computer program, computer, reproducible computer-readable signal encoding the computer program” nothing in the claim element precludes the step from practically being performed in the mind. For example, but for the “controller” language, “generating” in the context of this claim encompasses the user manually producing a data table listing identified abnormalities. Similarly, the providing, data table to a user, under its broadest reasonable interpretation, covers performance of the limitation in the mind, but for the recitation of generic computer components. If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation in the mind, but for the recitation of generic computer components, then it falls within the “Mental Processes” grouping of abstract ideas. Accordingly, the claim recites an abstract idea.
This judicial exception is not integrated into a practical application. In particular, the claims recite the additional elements of using a “communication unit, controller, user interface, computer program, computer, reproducible computer-readable signal encoding the computer program” to perform all of the “obtaining, transforming, parsing, determining, transforming, selecting and storing” steps. The “communication unit, controller, user interface, computer program, computer, reproducible computer-readable signal encoding the computer program” is/are recited at a high-level of generality (i.e., as a generic processor performing a generic computer function) of executing computer-executable instructions for implementing the specified logical function(s) such that it amounts no more than mere instructions to apply the exception using a generic computer component. Accordingly, this additional element does not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea. The claim is directed to an abstract idea.
Claim 1 has the following additional elements (i.e., user interface). Claim 23 has the following additional elements (i.e., communication unit, controller, user interface). Claim 28 has the following additional elements (i.e., computer program, computer). Claim 29 has the following additional elements (i.e., reproducible computer-readable signal encoding the computer program). Looking to the specification, these components are described at a high level of generality (page 11 || 12-15: The method is a computer-implemented method or a computer supported method at least. Therefore, it is a further object of the invention to provide a related computer program, a related computer readable medium, a related computer-readable signal, and a related data carrier signal. Page 57 || 17-18: The computer that is caused to carry out the method may be a computer or a computer network of the system in any embodiment disclosed). The use of a general-purpose computer, taken alone, does not impose any meaningful limitation on the computer implementation of the abstract idea, so it does not amount to significantly more than the abstract idea. Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements individually. The combination of elements does not indicate a significant improvement to the functioning of a computer or any other technology and their collective functions merely provide a conventional computer implementation of the abstract idea. Furthermore, the additional elements or combination of elements in the claims, other than the abstract idea per se, amount to no more than a recitation of generally linking the abstract idea to a particular technological environment or field of use, as the courts have found in Parker v. Flook. Therefore, there are no limitations in the claims that transform the judicial exception into a patent eligible application such that the claims amount to significantly more than the judicial exception.
It is worth noting that the above analysis already encompasses each of the current dependent claims (i.e., claims 2-22 and 24-27). Particularly, each of the dependent claims also fails to amount to “significantly more’ than the abstract idea since each dependent claim is directed to a further abstract idea, and/or a further conventional computer element/function utilized to facilitate the abstract idea. Accordingly, none of the current claims implements an element—or a combination of elements—directed to an inventive concept (e.g., none of the current claims is reciting an element—or a combination of elements—that provides a technological improvement over the existing/conventional technology). These information characteristics do not change the fundamental analogy to the abstract idea grouping of “Mental Processes,” and, when viewed individually or as a whole, they do not add anything substantial beyond the abstract idea. Furthermore, the combination of elements does not indicate a significant improvement to the functioning of a computer or any other technology. Therefore, the claims when taken as a whole are ineligible for the same reasons as the independent claims.
Additionally, Claim 29 is not drawn to eligible subject matter as it is directed to an abstract idea without significantly more. Claim 29 is rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter.
Claim 29 is rejected because it does not sufficiently recite a non-transitory computer readable storage medium. The United States Patent and Trademark Office (USPTO) is obliged to give claims their broadest reasonable interpretation consistent with the specification during proceedings before the USPTO. See In re Zletz, 893 F.2d 319(Fed. Cir. 1989) (during patent examination the pending claims must be interpreted as broadly as their terms reasonably allow). The broadest reasonable interpretation of a claim drawn to a computer readable medium (also called machine readable medium and other such variations) typically covers forms of non-transitory tangible media and transitory propagating signals per se in view of the ordinary and customary meaning of computer readable media, particularly when the specification is silent. See MPEP 2111.01. When the broadest reasonable interpretation of a claim covers a signal per se, the claim must be rejected under 35 U.S.C. §101 as covering non-statutory subject matter. See In re Nuijten, 500 F.3d 1346, 1356-57 (Fed. Cir. 2007) (transitory embodiments are not directed to statutory subject matter) and Interim Examination Instructions for Evaluating Subject Matter Eligibility Under 35 U.S.C. §101, Aug. 24, 2009; p. 2.
The USPTO recognizes that applicants may have claims directed to computer readable media that cover signals per se, which the USPTO must reject under 35 U.S.C. §101 as covering both non-statutory subject matter and statutory subject matter. In an effort to assist the patent community in overcoming a rejection or potential rejection under 35 U.S.C. §101 in this situation, the USPTO suggests the following approach. A claim drawn to such a computer readable medium that covers both transitory and non-transitory embodiments may be amended to narrow the claim to cover only statutory embodiments to avoid a rejection under 35 U.S.C. §101 by adding the limitation "non-transitory" to the claim. Cf. Animals – Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (suggesting that applicants add the limitation "non-human" to a claim covering a multi-cellular organism to avoid a rejection under 35 U.S.C. §101). Such an amendment would typically not raise the issue of new matter, even when the specification is silent because the broadest reasonable interpretation relies on the ordinary and customary meaning that includes signals per se. The limited situations in which such an amendment could raise issues of new matter occur, for example, when the specification does not support a non-transitory embodiment because a signal per se is the only viable embodiment such that the amended claim is impermissibly broadened beyond the supporting disclosure. See, e.g., Gentry Gallery, Inc. v. Berkline Corp., 134 F.3d 1473 (Fed. Cir. 1998).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-29 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2020041693 A1 to Douglas et al. in view of Pub. No.: US 20200160982 A1 to Gurson et al.
As per Claim 1, Douglas et al. teaches a computer-implemented method for supporting observation of a medical abnormality (2) in or on a body portion displayed in a virtual medical presentation of the body portion, the method comprises:
-- A step (S 1) of screening a virtual current presentation of a current study of the body portion for the abnormality (2);
-- A step (S2) of identifying separate abnormalities in the current presentation;
-- A step (S3) of determining, for each identified abnormality, a position information indicating the position of the identified abnormality in the current presentation, wherein the step (S3) of determining is an automated or semi-automated step.
See Douglas et al. paragraph 4; Some implementations comprise automatically displaying information associated with a selected sub-volume of the three-dimensional image volume. Some implementations comprise displaying patient's meta data and current condition for which obtaining the medical image volume was prompted, patient's medical history, laboratory results, and pathology results. Some implementations comprise displaying the information with a virtual windshield. Some implementations comprise displaying distances to key metrics with a virtual road sign. Some implementations comprise displaying a visual aid icon indicating viewing perspective.
Some implementations comprise displaying a visual aid icon indicating a finding detected by an artificial intelligence algorithm. Some implementations comprise displaying a visual aid icon indicating location of a sub-volume being displayed relative to the three- dimensional medical image volume or patient's body.
See Douglas et al. paragraph 26, Figs. 5 & 9; In some implementations, a virtual table could be added to the tool kit which would have virtual storage bins on the table. Sub-volume(s) of the virtual medical image which is currently being examined and which contain tissue of concern/ interest could be placed in the virtual storage bin(s). The bins for the sub-volumes could correspond to checklist items of the medical institution. In some implementations, an emergency bin could be added which could be accessed by both reviewing medical person and treatment personnel, thereby facilitating and expediting collaboration between these persons. In some implementations, the report preparation could be expedited by automatically sequencing through the bins and, extracting items, and adding these items to the report. The added items (e.g., an annotated figure containing the tissue in question) would add to both the quality and completeness of the report. Anytime a radiologist finds something anomalous, he/she puts it on the report virtual table. The item placed on the report virtual table may include the 2D slice or the 3D volume containing the anomalous finding. The radiologist has options to determine the size of the virtual table and virtual bins. One radiologist can pass an item onto another radiologist’s table or bin for collaboration.
Douglas et al. teaches a step (S4, S4') of generating a table (4) listing the identified abnormalities (2), however, does not explicitly teach:
-- for each listed abnormality, a position information indicating the position of the abnormality in the body portion;
-- A step (S5) of providing the table to a user via a user interface (3).
Gurson et al. teaches in some examples, for instance, the method can minimize a number of actions (e.g., mouse clicks, keyboard clicks, hotkey clicks, etc.) required by a radiologist during part or all of a conventional radiology workflow. In a set of specific examples, abnormal findings are displayed to a radiologist (e.g., at a PACS workstation) with zero clicks and normal findings are displayed with one action (e.g., mouse click, hover, etc.).
Abnormal findings can include any or all of: uncharacteristic or unexpected features (e.g., unexpected anatomical feature, etc.), such as those uncharacteristic in size (e.g., smaller, larger, etc.), volume, material composition (e.g., density, stiffness, tissue composition, etc.), shape (e.g., irregular outline, symmetric, asymmetric, etc.), location, or any other features. Additionally, or alternatively, abnormal findings can include any or all of: disease states (e.g., presence of mass, tumor, etc.), medical indications, illnesses, irregularities (e.g., anatomical irregularities), or other suitable features. Further additionally or alternatively, abnormal findings can include pertinent negatives and/or pertinent positives. (see paragraphs 18 and 33).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to include systems/methods as taught by reference Gurson et al. within the methods/systems as taught by reference Douglas et al. with the motivation of providing a method that can require one or more clicks to display normal findings, thereby making all information accessible but only automatically displaying the most important results (e.g., to minimize crowding of annotations on a display, reduce time to intervention, etc.) (see Gurson et al. paragraph 20).
Examiner notes that Claim 1 (and dependent claims) is/are rejected because it merely presents information without a credible technical effect using a computer interface that emulates a standard paper medical chart. The method is defined at an abstract level, failing to specify the study data, abnormalities, or system used in gathering or providing data. With undefined inputs and processes, it is not clear how the method identifies abnormalities or achieves its stated purpose of supporting medical observation. Consequently, the claim(s) lack(s) the required technical character for patentability.
Examiner notes for Making Automatic please refer to In re Venner, 120 USPQ 192 (CCPA 1958) In re Rundell, 9 USPQ 220; It is not 'invention' to broadly provide a mechanical or automatic means to replace manual activity which has accomplished the same result.
As per Claim 2, Douglas et al. and Gurson et al. teach the method according to claim 1, wherein the table is editable by the user via the user interface, and wherein the method comprises a step of correcting and/or validating the table (See Douglas et al. paragraph 26; Anytime a radiologist finds something anomalous, he/she puts it on the report virtual table).
As per Claim 3, Douglas et al. and Gurson et al. teach the method according to claim 1 or 2, wherein the table comprises entries for identified abnormalities, wherein an entry of the table comprises a sub-entry that relates to a characteristic of the abnormality attributed to the entry (See Douglas et al. paragraph 26; Anytime a radiologist finds something anomalous, he/she puts it on the report virtual table).
As per Claim 4, Douglas et al. and Gurson et al. teach the method according to claim 3, wherein, besides the position information, at least one of the following characteristics of the abnormality is listed in the sub- entries: The anatomical extent of the abnormality, the anatomical aspect of the abnormality, the signal characteristic of the abnormality, whether the abnormality is observed for the first time or not, the volume of the abnormality, information concerning contrast uptake, information derived from at least one of the above- listed information (See Douglas et al. paragraph 26; Anytime a radiologist finds something anomalous, he/she puts it on the report virtual table).
As per Claim 5, Douglas et al. and Gurson et al. teach the method according to claim 3 or 4, wherein the characteristic of an identified abnormality is determined in an automated or semi-automated manner and wherein the sub-entry of the entry for the identified abnormalities is filled with the characteristic in an automated or semi-automated manner (See Douglas et al. paragraph 26; Anytime a radiologist finds something anomalous, he/she puts it on the report virtual table).
As per Claim 6, Douglas et al. and Gurson et al. teach the method according to one of claims 1-5, wherein the step (S1) of screening and the step (S2) of identifying are automated or semi-automated steps, wherein the table is generated in an automated manner, and wherein a virtual presentation of the body portion comprised in the current study is provided to the user via the user interface (3) in the step (S5) of providing the table, wherein the user interface comprises an image viewer (5) and the virtual presentation is displayed in the image viewer (See Douglas et al. paragraphs 4 and 26; Some implementations comprise displaying the information with a virtual windshield).
As per Claim 7, Douglas et al. and Gurson et al. teach the method according to one of claims 1-5, wherein the step (S2) of identifying is carried out by the user (See Douglas et al. paragraph 26; Anytime a radiologist finds something anomalous, he/she puts it on the report virtual table).
As per Claim 8, Douglas et al. and Gurson et al. teach the method according to claim 7, wherein the step (S4, S4') of generating a table is semi-automated by an entry for an identified abnormality being generated by indicating the identified abnormality in a virtual presentation displayed in the image viewer (See Douglas et al. paragraphs 4 and 26; Anytime a radiologist finds something anomalous, he/she puts it on the report virtual table; Some implementations comprise displaying the information with a virtual windshield).
As per Claim 9, Douglas et al. and Gurson et al. teach the method according to claim 7 or 8, comprising further:
-- an automated step of screening the virtual current presentation of a current study of the body portion for the abnormality (2); -- an automated step of identifying separate abnormalities in the current presentation; -- an automated step of determining, for each abnormality identified in the automated step of identifying, a position information indicating the position of the identified abnormality in the current presentation; -- an automated step of generating a table listing the abnormalities (2) identified in the automated step of identifying and, for each listed abnormality, a position information indicating the position of the abnormality in the body portion (See Douglas et al. paragraphs 4 and 26).
As per Claim 10, Douglas et al. and Gurson et al. teach the method according to claim 9, comprising a step of providing the table generated in the automated step of generating a table or at least an entry thereof to the user (See Douglas et al. paragraphs 4 and 26).
As per Claim 11, Douglas et al. and Gurson et al. teach the method according to claim 10, wherein the step of providing the table generated in the automated step of generating a table or at least one entry thereof to the user is carried out if there is a difference between this table and the table generated in the step (S4, S4') of generating a table, wherein the abnormalities listed in the latter table have been identified in the step of identifying carried out by the user (See Douglas et al. paragraphs 4 and 26).
As per Claim 12, Douglas et al. and Gurson et al. teach the method according to one of claims 1-11, comprising a step (S6) of determining, for each identified abnormality (2), whether there is a related abnormality in a virtual previous presentation of a previous study of the body portion by determining, using the position information indicating the position of the identified abnormality in the current presentation, whether there is an abnormality in the previous presentation having a position information indicating that the abnormality in the previous presentation corresponds to the abnormality identified in the current presentation, wherein the table (4) indicates whether there is a related abnormality in the previous presentation or not (See Douglas et al. paragraphs 4 and 26).
As per Claim 13, Douglas et al. and Gurson et al. teach the method according to claim 12, wherein the step (S6) of determining, for each identified abnormality (2), whether there is a related abnormality in a virtual previous presentation of the body portion comprises:
-- A step of generating a current data set comprising, for each identified abnormality, a current data element, wherein the current data element comprises the position information indicating the position of the identified abnormality in the current presentation, wherein the step of generating a current data set is an automated step; -- A step of receiving, in an automated manner, a previous data set of the previous presentation of the body portion, wherein the previous data set comprises, for each abnormality identified in the previous presentation, a previous data element, wherein the previous data element comprises a position information indicating the position of the abnormality identified in the previous presentation; -- A step of screening, for each current data element, the previous data set for a previous data element comprising the abnormality at a position in the previous presentation that corresponds to the position of the abnormality according to the current data element, wherein the step of screening the previous data set is an automated step (See Douglas et al. paragraphs 4 and 26).
As per Claim 14, Douglas et al. and Gurson et al. teach the method according to claim 13, comprising a step of setting an evolution tag for each current data element for which a previous data element comprising the abnormality at a position in the previous presentation that corresponds to the position of the abnormality according to the current data element was found, wherein the step of setting an evolution tag is an automated step (See Douglas et al. paragraphs 4 and 26).
As per Claim 15, Douglas et al. and Gurson et al. teach the method according to one of claims 1-14, comprising:
-- A step of providing a list of studies (73) comprising a first item that is characteristic for the current study and a second item that is characteristic for a previous study (See Douglas et al. paragraphs 4 and 26);
-- A step of providing a list of presentations comprising at least one item that is characteristic for a kind of presentation (See Douglas et al. paragraphs 4 and 26);
-- A step of attributing a unique identifier to each of the virtual presentations of the current study or of a selection thereof, and of attributing a unique identifier to each of the virtual presentations of the previous study or of a selection thereof, wherein each unique identifier comprises an identifier of a first kind of identifier and an identifier of a second kind of identifier, wherein each identifier of the first kind of identifier represents one item of the list of studies in a unique manner, and wherein each identifier of the second kind of identifier represents one item of the list of presentations in a unique manner (See Douglas et al. paragraphs 4 and 26);
-- A step of providing to the user via the user interface (3) the list of studies or an adapted list of studies and the list of presentations or an adapted list of presentations, wherein the user interface comprises a first view (61) for the list of studies or the adapted list of studies and a second view (62) for the list of presentations or the adapted list of presentations (See Douglas et al. paragraphs 4 and 26);
-- A step of navigating through at least one of the virtual presentations of the current study having attributed unique identifiers and the virtual presentations of the previous study having attributed unique identifiers by selecting an item of the list shown in the first view and by selecting an item of the list shown in the second view, wherein the step of navigating comprises displaying a virtual presentation in an image viewer, wherein the displayed virtual presentation has the unique identifier comprising the identifier of the first kind of identifier that represents the item selected in the list of studies and the identifier of the second kind of identifier that represents the item selected in the list of presentations (See Douglas et al. paragraphs 4, 26 and 42)
As per Claim 16, Douglas et al. and Gurson et al. teach the method according to claim 15, wherein the user interface (3) comprises tools allowing the user to at least one of:
-- Replacing the presentation (6) displayed in the image viewer (5) with a replacement presentation that corresponds to the presentation assigned to the item arranged in the list shown in the second view (62) precedingly or subsequently to the item to which the presentation displayed in the image viewer is assigned;
-- Replacing the presentation (6) displayed in the image viewer (5) with a replacement presentation that belongs to the study assigned to the item arranged in the list shown in the first view (61) precedingly or subsequently to the item to which the study is assigned to which the presentation displayed in the image viewer belongs;
-- Switching back and forth between displaying in the image viewer (5) a first presentation and a second presentation, wherein the first presentation is a presentation assigned to a first item in the list shown in the second view (62) and the second presentation is a presentation assigned to a second item in the list shown in the second view;
-- Switching back and forth between displaying in the image viewer (5) a first presentation and a second presentation, wherein the first presentation is a presentation of the study assigned to a first item in the list shown in the first view (61) and the second presentation is a presentation of the study assigned to a second item in the list shown in the first view (see Douglas et al. paragraph 74; Figure 22 illustrates a virtual moveable table for storing virtual images of suspect tissue stored by checklist category. This figure depicts a virtual movable table 2200 on which there are virtual storage bins that correspond to items on the medical institution checklist 2202, plus a bin for emergency items 2204, and a general/ miscellaneous bin 2206 (e.g., image artifact, teaching case, quality improvement, etc.). The emergency bin 2204 could be used for placing findings for items of critical time sensitive information. The virtual mobile table is mobile in the sense that the user could view the virtual mobile table on an extended reality headset off to the side away from the imaging volume that the radiologist is currently working on. Then, the radiologist could move it or size it, such that it convenient for the work space. Items the medical personnel consider significant would be “dragged and placed” in the respective virtual bins according to the checklist item being reviewed. For bins without significant items, there would be a statement ‘unremarkable’ on the checklist item on the report which goes away when an item is added, and the radiologist would replace that item on the checklist with the appropriate description.).
As per Claim 17, Douglas et al. and Gurson et al. teach the method according to one of claims 1-16, wherein the step (SI) of screening the current presentation for the abnormality (2), comprises a step of running a model of an artificial intelligence, wherein the model is trained for assigning a probability to each voxel of a presentation of the body portion that the voxel belongs to the abnormality (see Douglas et al. paragraphs 4, 26 and 42; Some implementations comprise displaying a visual aid icon indicating a finding detected by an artificial intelligence algorithm).
As per Claim 18, Douglas et al. and Gurson et al. teach the method according to claim 17, wherein the step of running a model of an artificial intelligence comprises running a plurality of models of the artificial intelligence and/or a model of a first artificial intelligence and a model of a second artificial intelligence, wherein the models run are trained for assigning a probability to each voxel of a presentation of the body portion that the voxel belongs to the abnormality, wherein, for each model run, a probability segmentation map is generated, and wherein the user can select a generated probability segmentation map (see Douglas et al. paragraphs 4, 26 and 42; Some implementations comprise displaying a visual aid icon indicating a finding detected by an artificial intelligence algorithm).
As per Claim 19, Douglas et al. and Gurson et al. teach the method according to one of claims 1-18, wherein the position information indicating the position of the abnormality in the body portion is provided in an automated manner by at least one of:
-- Providing a virtual template of the body portion, wherein anatomic locations are labeled in the virtual template, wherein the virtual template and the virtual current presentation are brought in dense correspondence, and wherein the labels are transferred from the virtual template to the virtual current presentation;
-- Running a model of an artificial intelligence, wherein the model is trained for assigning regions shown in a virtual presentation showing the body portion to anatomic locations (see Douglas et al. paragraphs 4, 9-10, 26 and 42; In some implementations, the medical person conducting the review of volumetric medical images could invoke a process whereby a virtual radiology assistant type icon is displayed. The purpose of the virtual radiology assistant type icon is to portray all relevant/ important information relating to inter alia: where the medical person conducting the examination is on the medical institution’s checklist and what’s next; patient’s meta data and current condition triggering obtaining medical image(s); patient’s medical history; laboratory results; results, if any, from application of artificial intelligence (AI) routines and indicators of condition. In this implementation, the medical person conducting the review could command display of the virtual windshield at any time. In this implementation, the medical person conducting the review could also modify items to be shown on the windshield. In some implementations, virtual tools can direct voxel alterations. Examples of voxel manipulations include changing the size, shape, position, orientation or internal parameter of a voxel. Furthermore, voxels can be created or eliminated at the direction of the virtual tool).
As per Claim 20, Douglas et al. and Gurson et al. teach the method according to one of claims 1-19, wherein at least one of the following apply:
-- The method comprises a step (S8) of correcting by the user the extend and/or position of an identified abnormality by at least one of the following:
i. by modifying at least one of a minimal probability-value that is considered in the step (S1) of screening the current presentation for the abnormality and a maximal probability-value that is considered in the step (S1) of screening the current presentation for the abnormality;
ii. by directly adding voxels to or removing voxels from a set of voxels representing an abnormality listed in the table;
iii. by indicating a corrected extension and/or corrected position in the presentation displayed in the image viewer (5);
iv. by selecting one of a plurality of probability segmentation maps that is generated in the step (S1) of screening the current presentation for the abnormality.
-- The method comprises a step of generating at least one of the following lists for at least one abnormality listed in the table:
i. A list comprising a plurality of position information indicating the position of the abnormality (2) in the body portion;
ii. A list comprising a plurality of evolution information indicating the presence of the abnormality at a specific date;
iii. A list comprising a plurality of contrast uptake information of the abnormality;
-- A new entry for an abnormality not listed in the table (4) can be generated in the table by the user and an extension and/or position of the abnormality can be defined by the user by indicating the extension and/or position in the presentation displayed in the image viewer (5).
-- An entry for an abnormality can be removed from the table (4) (See Douglas et al. paragraphs 4, 9, 26, 42 and 63, The medical person viewing the medical images modify the factors changing the spread between the sub-volumes during the course of the examination. For example, a moderate spread is shown 1170. Alternatively, a larger spread is shown 1172.).
As per Claim 21, Douglas et al. and Gurson et al. teach the method according to one of claims 1-20, comprising a step of providing a radiological report, wherein the report comprises information given in or linked to the table (4) (Douglas et al. paragraph 26, Figs. 5 & 9; In some implementations, a virtual table could be added to the tool kit which would have virtual storage bins on the table. Sub-volume(s) of the virtual medical image which is currently being examined and which contain tissue of concern/ interest could be placed in the virtual storage bin(s). The bins for the sub-volumes could correspond to checklist items of the medical institution. In some implementations, an emergency bin could be added which could be accessed by both reviewing medical person and treatment personnel, thereby facilitating and expediting collaboration between these persons. In some implementations, the report preparation could be expedited by automatically sequencing through the bins and, extracting items, and adding these items to the report. The added items (e.g., an annotated figure containing the tissue in question) would add to both the quality and completeness of the report. Anytime a radiologist finds something anomalous, he/she puts it on the report virtual table. The item placed on the report virtual table may include the 2D slice or the 3D volume containing the anomalous finding. The radiologist has options to determine the size of the virtual table and virtual bins. One radiologist can pass an item onto another radiologist’s table or bin for collaboration.).
As per Claim 22, Douglas et al. and Gurson et al. teach the method according to claim 21, wherein the report comprises at least one of the following information: The abnormalities identified in the current study, the position of each identified abnormality in the body portion, a hint whether the abnormality was identified in a previous study or not, the extend of each identified abnormality, the abnormalities identified in a previous study but not in the current study, the position and/or extend of the abnormalities identified in a previous study but not in the current study, a presentation of each abnormality identified in the current study, a presentation that is representative for the medical condition according to the current study, a summary list (Douglas et al. paragraph 26, Figs. 5 & 9; In some implementations, a virtual table could be added to the tool kit which would have virtual storage bins on the table. Sub-volume(s) of the virtual medical image which is currently being examined and which contain tissue of concern/ interest could be placed in the virtual storage bin(s). The bins for the sub-volumes could correspond to checklist items of the medical institution. In some implementations, an emergency bin could be added which could be accessed by both reviewing medical person and treatment personnel, thereby facilitating and expediting collaboration between these persons. In some implementations, the report preparation could be expedited by automatically sequencing through the bins and, extracting items, and adding these items to the report. The added items (e.g., an annotated figure containing the tissue in question) would add to both the quality and completeness of the report. Anytime a radiologist finds something anomalous, he/she puts it on the report virtual table. The item placed on the report virtual table may include the 2D slice or the 3D volume containing the anomalous finding. The radiologist has options to determine the size of the virtual table and virtual bins. One radiologist can pass an item onto another radiologist’s table or bin for collaboration.).
As per Claims 23-27, Claims 23-27 are directed to a system (40) for supporting observation of a medical abnormality (2) in or on a body portion displayed in a virtual medical presentation of the body portion, the system comprises a communication unit (4l), a controller (46) and a user interface (3). Claims 23-27 recite the same or substantially similar limitations as those addressed above for Claims 1-22 as taught by Douglas et al. and Gurson et al. Claims 23-27 are therefore rejected for the same reasons as set forth above for Claims 1-22 respectively.
As per Claim 28, Claim 28 is directed to a computer program comprising instructions which, when the program is executed by a computer, cause the computer to execute the steps of the method according to one of the claims 1-22. Claim 28 recites the same or substantially similar limitations as those addressed above for Claims 1-22 as taught by Douglas et al. and Gurson et al. Claim 28 is therefore rejected for the same reasons as set forth above for Claims 1-22 respectively.
As per Claim 29, Claim 29 is directed to a reproducible computer-readable signal encoding the computer program according to claim 28. Claim 29 recites the same or substantially similar limitations as those addressed above for Claims 1-28 as taught by Douglas et al. and Gurson et al. Claim 29 is therefore rejected for the same reasons as set forth above for Claims 1-28 respectively.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
WO 2020106631 A1; The listing system (1100) has non-transitory processor-readable storage medium that stores processor-executable instructions or data. The processor is communicably coupled to non-transitory processor-readable storage medium. The processor is configured to receive a list of radiological studies from a database. The radiological studies are included with image data. The image data associated with the radiological studies is received and the image data is automatically processed in order to determine which images are likely to contain abnormalities. The list of radiological studies or associated images is displayed.
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/E.B.W/ Examiner, Art Unit 3683
/ROBERT W MORGAN/ Supervisory Patent Examiner, Art Unit 3683