Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
DETAILED ACTION
Status of Claims
The present Office Action is pursuant to Applicant’s communication on 03-18-2025; current application filed on 03-18-2025. This application is a 371 of PCT/EP2021/068036 06/30/2021. This application claims foreign priority to JAPAN JP2024-067562 04/18/2024 JAPAN JP2025-015475 01/31/2025.
Information Disclosure Statement
The information disclosure statement(s) (IDS) filed on 03-18-2025, have been acknowledged. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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 1-11 is/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.
Step 1
Claim(s) 1-11 is/are within the four statutory categories. Claim(s) 1-11 is/are drawn to an apparatus1, method2 which means that said claims(s) is/are within the four statutory categories (i.e. process). However, as will be shown below, arguendo, Aforementioned claim(s) is/are nonetheless unpatentable under 35 U.S.C. 101.
Prong 1 of Step 2A
Claim(s) 1, 8, 11, which is/are representative of the inventive concept, recite(s):
…:
“select[ing] an imaging condition…”;
“determin[ining] whether or not checking by an approver is required …”
“send[ing] the imaging condition to a terminal …”.
The underlined limitations as shown above, given the broadest reasonable interpretation, cover the abstract ideas of a mental process and/or a certain method of organizing human activity because they recite a process that could be practically performed in the human mind (i.e. observations, evaluations, judgments, and/or opinions – in this case selection and determination whether or not checking is required in association with imaging condition, or using a pen and paper, but for the recitation of generic computer components (i.e. the computer), and/or managing personal behavior or relationships or interactions between people (i.e. social activities, teaching, and following rules or instructions, e.g. see MPEP 2106.04(a)(2). Any limitations not identified above as part of the abstract ideas are deemed “additional elements,” and will be discussed in further detail below.
Dependent claim(s) 2-7 and 9-10, include other limitations, for example:
2. The medical information communication apparatus according to claim 1, wherein the processing circuitry is configured to, if additional information indicating that 15 the checking by the approver is required is set, send the imaging condition to the terminal once selection of the imaging condition is completed.
3. The medical information communication apparatus according to claim 2, wherein the processing circuitry is configured to send a positioning image to the terminal before the selection of the imaging condition, the positioning image being acquired in advance of acquiring the medical data.
4. The medical information communication apparatus according to claim 1, wherein the processing circuitry is configured to, if checking by more than one approver is required for the imaging condition, send the imaging. condition to the more than one approver in an order according to priority scores.
5. The medical information communication apparatus according to claim 1, wherein the processing circuitry is further configured to acquire a corrected imaging condition which is the imaging condition corrected by the approver, wherein the processing circuitry is configured to select a new imaging condition again based on the corrected imaging condition.
6. The medical information communication apparatus according to claim 1, wherein the imaging condition includes a region of interest.
7. The medical information communication apparatus according to claim 1, wherein the processing circuitry is configured to wait for user input indicating that whether or not checking by the approver is required.
9. The medical information communication apparatus according to claim 8, wherein the processing circuitry is further configured to set additional information to the corrected imaging condition, the additional information indicating that checking of an imaging condition that is selected again based on the corrected imaging condition is 5 required. 10. The medical information communication apparatus according to claim 8, wherein the imaging condition includes a region of interest.
However these dependent claims only serve to further narrow the abstract idea, and a claim may not preempt abstract ideas, even if the judicial exception is narrow, e.g. see MPEP 2106.04. Additionally, any limitations in dependent claim(s) 2-7 and 9-10 are deemed additional elements to the abstract idea, and will be further addressed below. Hence dependent claim(s) 2-7 and 9-10 are nonetheless directed towards fundamentally the same abstract idea as independent Claim(s) 1, 8, 11.
Prong 2 of Step 2A
Claim(s) 1, 8, 11 is/are not integrated into a practical application because the additional elements (i.e. the non-underlined limitations above – in this case processing circuitry) amount to no more than limitations which:
amount to mere instructions to apply an exception – for example, the recitation of a computer, which amounts to merely invoking a computer as a tool to perform the abstract idea, e.g. see Page(s) 1-31 of the present Specification, see MPEP 2106.05(f);
generally link the abstract idea to a particular technological environment or field of use, which amounts to limiting the abstract idea to the field of healthcare, see MPEP 2106.05(h); and/or
add insignificant extra-solution activity to the abstract idea, see MPEP 2106.05(g).
Additionally, dependent claim(s) 2-7 and 9-10 include other limitations, but these limitations also amount to no more than generally linking the abstract idea to a particular technological environment or field of use, and/or do not include any additional elements beyond those already recited in independent Claim(s) 1, 8, 11, hence also do not integrate the aforementioned abstract idea into a practical application.
Step 2B
Claim(s) 1, 8, 11 do/does not include additional elements that are sufficient to amount to “significantly more” than the judicial exception because the additional elements (i.e. the non-underlined limitations above – in this case the memory, computer processors, computer-readable media), as stated above, are directed towards no more than limitations that amount to mere instructions to apply the exception, generally link the abstract idea to a particular technological environment or field of use, and/or add insignificant extra-solution activity to the abstract idea, wherein the insignificant extra-solution activity comprises limitations which:
amount to elements that have been recognized as well-understood, routine, and conventional activity in particular fields, as demonstrated by:
The Specification expressly disclosing that the additional elements are well-understood, routine, and conventional in nature:
Page(s) 1-31 of the Specification discloses that the additional elements (i.e. the computer) comprise a plurality of different types of generic computing systems that are configured to perform generic computer functions (i.e. receive and process data) that are well-understood, routine, and conventional activities previously known to the pertinent industry (i.e. healthcare);
Relevant court decisions: The following are examples of court decisions demonstrating well-understood, routine and conventional activities, e.g. see MPEP 2106.05(d)(II):
Storing and retrieving information in memory, e.g. see Versata Dev. Group, Inc. v. SAP Am., Inc. – similarly, the current invention recites storing or uploading media;
Dependent claim(s) 2-7 and 9-10 include other limitations, but none of these limitations are deemed significantly more than the abstract idea because, as stated above, the limitations of the aforementioned dependent claims amount to no more than generally linking the abstract idea to a particular technological environment or field of use, and/or do not recite any additional elements not already recited in independent Claim(s) 1, 8, 11 hence does not amount to “significantly more” than the abstract idea.
Thus, taken alone, the additional elements do not amount to significantly more than the abstract idea identified above. Furthermore, looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually, and there is no indication that the combination of elements improves the functioning of a computer or improves any other technology, and their collective functions merely provide conventional computer implementation.
Therefore, whether taken individually or as an ordered combination, claim(s) 1-11 is/are nonetheless rejected under 35 U.S.C. 101 as being directed to non-statutory subject matter.
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 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 date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Elbaz (US 10,888,400) in view of Jin3.
Regarding claim(s) 1, Elbaz discloses: A medical information communication apparatus comprising processing circuitry4 configured to:
select an imaging condition for acquiring medical data (i.e., selecting an image in association with acquiring data from the image from a condition parameter such as a region of interest); [71:1-65: selecting a region of interest, said region automatically annotated by system based on a threshold comparison compared with an earlier scan, wherein an image’s position is associated with said region, marking via flagg[ing] is associated with a position of a structure in an image and allowing the marking or reject[ing] it]
Regarding [a]-[c], Elbaz does not disclose as disclosed by Jin:
determine whether or not checking by an approver is required for the imaging condition (i.e., determining based on mapping of data associated with protocols, that confirmations by pathologists would be necessary, providing feedback); [Claims 1, 2, page(s) 5-6, 13: wherein a clinical specialist adds additional details such as delineations of regions of interest whose main goal is directed to efficient review , and more efficient diagnosis in association with clinical protocol and radiology examination data]
send the imaging condition to a terminal configured to enable viewing by the approver if it is determined that the checking by the approver is required for the imaging condition (i.e., sending for review and/or approval by a specialist based on a comparison with a confidence value); [Page 4: sending to a referring physician]
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to have modified Elbaz, including mechanism(s) [b]-[c], as taught by Jin. One of ordinary skill would have been so motivated to employ said mechanism(s) to provide a better healthcare delivery. [Page 4]
Regarding claim(s) 2, Elbaz-Jin as a combination discloses: The medical information communication apparatus according to claim 1, Lim disclosing [a]: wherein the processing circuitry is configured to, if additional information indicating that the checking by the approver is required is set, send the imaging condition to the terminal once selection of the imaging condition is completed (i.e., sending for review and/or approval by a specialist based on a comparison with a confidence value). [Page 4: sending to a referring physician]
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to have modified Elbaz, including mechanism(s) [a], as taught by Jin. One of ordinary skill would have been so motivated to employ said mechanism(s) to provide a better healthcare delivery. [Page 4]
Regarding claim(s) 3, Elbaz-Jin as a combination discloses [a]: The medical information communication apparatus according to claim 2, Elbaz discloses: wherein the processing circuitry is configured to send a positioning image5 (i.e., wherein a positional image is a 3D scan, and a system is configured to send and receive said scans). [53:49-55] to the terminal, Jin disclosing: before the selection of the imaging condition, the positioning image being acquired in advance of acquiring the medical data (i.e., wherein support specialist review workflows are triggered before an event to optimize treatment). [Page 4]
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to have modified Elbaz, including mechanism(s) [a], as taught by Jin. One of ordinary skill would have been so motivated to employ said mechanism(s) to provide a better healthcare delivery. [Page 4]
Regarding claim(s) 4, Elbaz-Jin as a combination discloses: The medical information communication apparatus according to claim 1, Lim disclosing [a]: wherein the processing circuitry is configured to, if checking by more than one approver is required for the imaging condition, send the imaging condition to the more than one approver in an order according to priority scores (i.e., enabling one or more remote specialists). [Page 4: sending to a referring physician, wherein specialists include one or more “stakeholders”]
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to have modified Elbaz, including mechanism(s) [a], as taught by Jin. One of ordinary skill would have been so motivated to employ said mechanism(s) to provide a better healthcare delivery. [Page 4]
Regarding claim(s) 5, Elbaz-Jin as a combination discloses: The medical information communication apparatus according to claim 1, Jin disclosing [a]: wherein the processing circuitry is further configured to acquire a corrected imaging condition which is the imaging condition corrected by the approver, wherein the processing circuitry is configured to select a new imaging condition again based on the corrected imaging condition. [Claims 1, 2, page(s) 5-6, 13: wherein a clinical specialist adds additional details such as delineations of regions of interest whose main goal is directed to efficient review, and more efficient diagnosis in association with clinical protocol and radiology examination data]
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to have modified Elbaz, including mechanism(s) [a], as taught by Jin. One of ordinary skill would have been so motivated to employ said mechanism(s) to provide a better healthcare delivery. [Claims 1, 2, pages 5-6, 13]
Regarding claim(s) 6, Elbaz-Jin as a combination discloses: The medical information communication apparatus according to claim 1, Elbaz discloses: wherein the imaging condition includes a region of interest. [71:1-65: selecting a region of interest, said region automatically annotated by system based on a threshold comparison compared with an earlier scan, wherein an image’s position is associated with said region]
Regarding claim(s) 7, Elbaz-Jin as a combination discloses: The medical information communication apparatus according to claim 1, Elbaz discloses: wherein the processing circuitry is configured to wait for user input indicating that whether or not checking by the approver is required (i.e., allowing a user options to reject, modify or allow a flag, allowing corresponding to waiting for the allowed options to be selected). [71:49-57]
Regarding claim(s) 8, Elbaz discloses: A medical information communication apparatus comprising processing circuitry configured to:
acquire an imaging condition selected for acquiring medical data, and a positioning image from a terminal operable by a requester (i.e., selecting an image in association with acquiring data from the image from a condition parameter such as a region of interest); [71:1-65: selecting a region of interest, said region automatically annotated by system based on a threshold comparison compared with an earlier scan, wherein an image’s position is associated with said region, marking via flagg[ing] is associated with a position of a structure in an image and allowing the marking or reject[ing] it, positioning image6 being provided as depicted in 53:49-55];
Regarding [a]-[b], Elbaz does not disclose an imaging condition as disclosed by Jin (i.e., determining based on mapping of data associated with protocols, that confirmations by pathologists would be necessary, providing feedback); [Claims 1, 2, page(s) 5-6, 13: wherein a clinical specialist adds additional details such as delineations of regions of interest whose main goal is directed to efficient review , and more efficient diagnosis in association with clinical protocol and radiology examination data]
send an indication of whether or not the imaging condition is corrected and, if the imaging condition is corrected, the corrected imaging condition to the terminal operable by the requester (i.e., determining based on mapping of data associated with protocols, that confirmations by pathologists would be necessary, providing feedback). [Page 4: sending to a referring physician]
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to have modified Elbaz, including mechanism(s) [a]-[b], as taught by Jin. One of ordinary skill would have been so motivated to employ said mechanism(s) to provide a better healthcare delivery. [Page 4]
Regarding claim(s) 9, Elbaz-Jin as a combination discloses: The medical information communication apparatus according to claim 8, Jin discloses [a]: wherein the processing circuitry is further configured to set additional information to the corrected imaging condition, the additional information indicating that checking of an imaging condition that is selected again based on the corrected imaging condition is required (i.e., determining based on mapping of data associated with protocols, that confirmations by pathologists would be necessary, providing feedback); [Claims 1, 2, page(s) 5-6, 13: wherein a clinical specialist adds additional details such as delineations of regions of interest whose main goal is directed to efficient review , and more efficient diagnosis in association with clinical protocol and radiology examination data]
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to have modified Elaz, including mechanism(s) [a], as taught by Jin. One of ordinary skill would have been so motivated to employ said mechanism(s) to provide a better healthcare delivery. [Claims 1, 2, pages 5-6, 13]
Regarding claim(s) 10, Elbaz-Jin as a combination discloses: The medical information communication apparatus according to claim 8, Elbaz discloses: wherein the imaging condition includes a region of interest. [71:1-65: selecting a region of interest, said region automatically annotated by system based on a threshold comparison compared with an earlier scan, wherein an image’s position is associated with said region]
Regarding claim(s) 11, Elbaz discloses: A medical information communication method comprising:
selecting an imaging condition for acquiring medical data (i.e., selecting an image in association with acquiring data from the image from a condition parameter such as a region of interest); [71:1-65: selecting a region of interest, said region automatically annotated by system based on a threshold comparison compared with an earlier scan, wherein an image’s position is associated with said region, marking via flagg[ing] is associated with a position of a structure in an image and allowing the marking or reject[ing] it]
Regarding [a]-[b], Elbaz does not disclose as disclosed by Jin:
determining whether or not checking by an approver is required for the imaging condition (i.e., determining based on mapping of data associated with protocols, that confirmations by pathologists would be necessary, providing feedback); [Claims 1, 2, page(s) 5-6, 13: wherein a clinical specialist adds additional details such as delineations of regions of interest whose main goal is directed to efficient review , and more efficient diagnosis in association with clinical protocol and radiology examination data]
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to have modified Elaz, including mechanism(s) [b]-[c], as taught by Jin. One of ordinary skill would have been so motivated to employ said mechanism(s) to provide a better healthcare delivery. [Claims 1, 2, pages 5-6, 13]
sending the imaging condition to a terminal configured to enable viewing by the approver if it is determined that the checking by the approver is required for the imaging condition (i.e., sending for review and/or approval by a specialist based on a comparison with a confidence value); [Page 4: sending to a referring physician]
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to have modified Elbaz, including mechanism(s) [a]-[c], as taught by Jin. One of ordinary skill would have been so motivated to employ said mechanism(s) to provide a better healthcare delivery. [Page 4]
Conclusion
The prior art made of record7 and NOT relied upon is considered pertinent to applicant's disclosure: Caluser (US 11,109,835):
An automated 3D mapping and display system includes automated ultrasound probe position registration, calculation of the position of each pixel in the ultrasound image in reference to selected anatomical references, and storage of specified information on command. The system, during real time ultrasound scanning, enables ultrasound probe position and orientation to be continuously displayed over a body part diagram, thereby facilitating scanning and images interpretation of stored information. The system can record single or multiple ultrasound free hand frames in a video sequence or cine loop wherein multiple 2D frames of one or more video sequences corresponding to a scanned volume can be reconstructed in 3D volume images corresponding to the scanned region, using known 3D reconstruction algorithms. In later examinations, the exact location and position of the transducer can be recreated along 3D or 2D axis points enabling known targets to be viewed from an exact, known position.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL EZEWOKO whose telephone number is 571 272 7850. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Fonya Long can be reached on 571 270 5096. The fax phone number for the organization where this application or proceeding is assigned is 571-273-7850.
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/MICHAEL I EZEWOKO/Primary Examiner, Art Unit 3682
1 Claim(s) 1-10
2 Claim(s) 11
3 See Form 892: WO 2024/235686
4 Processing circuitry corresponding to one or more processors as hardware: see FIG 2, ¶29
5 This is consistent with Applicant Specification, page 17, lines 16-21
6 This is consistent with Applicant Specification, page 17, lines 16-21
7 Please see Form 892 for complete listing