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 .
Status of Claims
This Non-Final Office Action is in response to the Application filed on 09/17/2025. Claims 1-20 are pending and considered herein.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without practical application and without significantly more than the abstract idea.
Claim 12 recites the following, wherein the abstract limitations are not emboldened:
An ultrasound examination method, adapted for use with a computer device, wherein the computer device comprises a specialized software system and an ultrasound workstation system, the specialized software system provides specialized functions for specialized ultrasound examinations, and the specialized software system is connected to the ultrasound workstation system in a form of middleware; the method comprising: the ultrasound workstation system opening a patient report; the specialized software system obtaining an ultrasound examination task for a patient based on the patient report; the specialized software system transmitting the ultrasound examination task to an ultrasound device; the specialized software system receiving ultrasound data that corresponds to the ultrasound examination task from the ultrasound device; the specialized software system obtaining an examination result that is inputted by a user based on the ultrasound data; the ultrasound workstation system receiving the ultrasound data and the examination result that is sent by the specialized software system.
Independent claim 1 recites substantially the same limitations. The claimed invention is broadly directed to the abstract idea of collecting patient information, analyzing the information related to an ultrasound examination task, and determining an examination result based on the analyses using a generic computer system.
The subject matter of the claim recites the steps of “opening a patient report; obtaining an ultrasound examination task for a patient based on the patient report; transmitting the ultrasound examination task; receiving ultrasound data that corresponds to the ultrasound examination task; obtaining an examination result that is inputted by a user based on the ultrasound data; receiving the ultrasound data and the examination result that is sent,” as drafted, is a process that, under the broadest reasonable interpretation, is an abstract idea that covers performance of the limitation as certain methods of organizing human activity. For example, but for the generic recitation of a computer system, ultrasound workstation system and specialized software system, in the context of this claim, is an abstract idea that covers performance of the limitation as organizing human activity including following rules or instructions. These recited limitations fall within certain methods of organizing human activity grouping of abstract ideas because the limitations allowing access to patient data that is analyzed and an ultrasound exam is performed based on the analysis. This is a method of managing interactions between people. Under its broadest reasonable interpretation, the limitations are categorized as methods of organizing human activity, specifically associated with managing personal behavior or relationships or interactions between people including a physician and her patient. Therefore, the limitation falls within the “Certain Methods of Organizing Human Activity” grouping of abstract ideas. See MPEP § 2106.04(a). The mere nominal recitation of a generic computer system, ultrasound workstation system and specialized software system does not remove the claims from the method of organizing human interactions grouping. Thus, the claims recite an abstract idea.
This judicial exception is not integrated into a practical application. In particular, the claim recites the additional elements of a computer system, ultrasound workstation system and specialized software system, which are recited at a high-level of generality (i.e., as a generic processor/server/storage/display/sensor performing a generic computer function of receiving inputs and displaying selected information) such that it amounts no more than mere instructions to apply the exception using a generic computer component. Accordingly, the additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. In addition, there is no clear improvement to the underlying technology in the claim. The additional elements are merely used as a tool to apply the abstract idea (i.e., to control sending or receiving of data, see MPEP 2106.05(f)(2)). The additional element generally links the abstract idea to a particular technological environment or field of use. MPEP 2106.04(d)(I) indicates that generally linking an abstract idea to a particular technological environment or field of use cannot provide a practical application. Accordingly, even in combination, these additional elements do not integrate the abstract idea into a practical application. The claim is thus directed to an abstract idea.
The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application, the additional elements of computer system, ultrasound workstation system and specialized software system, alone or in combination, amount to no more than mere instructions to apply the exception using a generic computer component. Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept. Furthermore, the ultrasound workstation system generally links the abstract idea to a particular technological environment or field of use. MPEP 2106.05(A) indicates that generally linking an abstract idea to a particular technological environment or field of use cannot provide significantly more than the abstract idea (judicial exception). Therefore, when considering the additional elements alone and in combination, there is no inventive concept in the claim. Thus, the claim is not patent eligible.
The dependent claims recite additional subject matter which further narrows or defines the abstract idea embodied in the claims, or provide additional elements without significantly more. Claims 2-4 describe types of data input to a ultrasound workstation system, which is recited at a high level of generality and even in combination do not provide a practical application or significantly more than the abstract idea. Claims 5-6 and 13-14 describe an ultrasound examination task in more detail and further limits the abstract idea. Claims 7-19 and 15-19 describe software obtaining patient data and data related to obstetrics and data for patient history and data for fetal growth, which are recited at a high level of generality and, even in combination, do not provide a practical application or significantly more than the abstract idea. Claim 20 describes including patient ultrasound data into a patient report and to a medical record, which is recited at a high level of generality and, even in combination, do not provide a practical application or significantly more than the abstract idea. As discussed above with respect to discussion of integration of the abstract idea into a practical application, any additional elements amount to no more than mere instructions to apply the judicial exception, without more. For at least the reasons as stated above, the claims are not patent eligible.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-4, 7-12 and 15-19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. 2024/0371483 A1 to Canfield, II, hereinafter “Canfield.”
Regarding claim 1, Canfield discloses An ultrasound examination method, adapted for use with a specialized software system, wherein the specialized software system provides specialized functions for specialized ultrasound examinations, and is connected to an ultrasound workstation system in a form of middleware; the method comprising: obtaining an ultrasound examination task for a patient through the ultrasound workstation system (See Canfield at least at Abstract; Paras. [0003]-[0004] (“The ultrasound imaging system includes at least one processor configured to receive the ultrasound image data acquired by an ultrasound imaging device during the examination of the subject, including corresponding metadata, to generate an ultrasound image based on the ultrasound image data, and to generate a data set indicative of multiple measurements in the ultrasound image.”), [0020]-[0024], [0028]-[0032] (“The Patient Data field 206 enables the user to enter specific information regarding the subject of the ultrasound imaging examination, such as age, weight, gender, vital signs, and/or all or part of the subject's medical history. Alternatively, or in addition, the user may simply select the Patient Data field 206 element, which causes the GUI 114 and/or the prompt string generator 116 to retrieve patient data directly from a patient database, such as an electronic health record (EHR) database.”); Figs. 1-5); transmitting the ultrasound examination task to an ultrasound device (See id. at least at Paras. [0019]-[0020] (“The one or more communication channels 118 may be implemented over a wide area network (e.g., internet, cloud) or a local area network (e.g., Ethernet) […] The ultrasound imaging device 105 receives basic device settings from the user interface 110.”), [0059]-[0062] (transmitting and receiving ultrasound data); Figs. 1-5); receiving ultrasound data corresponding to the ultrasound examination task from the ultrasound device (See id. at least at Paras. [0059]-[0062] (transmitting and receiving ultrasound data); Claim 1 (“[T]o receive the user input from the GUI, (ii) to extract at least a type of examination and the data set from the at least one processor, (iii) to translate the user input, the type of examination, and the data set into a natural language prompt string in response to selection of the report selector, and (iv) to output the prompt string to an application programming interface (API) (117), wherein the prompt string is suitable for the type of examination and readable by the AI driven large language model, wherein the AI driven large language model receives the prompt string via the API and automatically generates the report suitable for the type of examination and the user input.”); Figs. 1-5); obtaining an examination result that is inputted by a user based on the ultrasound data (See id. at least at Paras. [0020]-[0021] (“[T] he data set may include the results of the desired measurements, and may associate the annotations with specified locations in the ultrasound images.”), [0038] (“When the user is satisfied with the results, the user displays the automated measurements and selects (e.g., presses) the report button.”); Claim 5; Figs. 1-5); and sending the ultrasound data and the examination result to the ultrasound workstation system (See id. at least at Paras. [0020]-[0022] (“[T] he data set may include the results of the desired measurements, and may associate the annotations with specified locations in the ultrasound images […] The display 113 enables display of all or part the information provided to the user interface 110 via the US interface 111, including the ultrasound images, the ultrasound image data associated with the ultrasound mages (including metadata), and the data sets responsive to the user's instructions. The metadata in particular includes context information, such as identification of the ultrasound imaging device 107, the settings, exam times, and the like.)”), [0038] (“When the user is satisfied with the results, the user displays the automated measurements and selects (e.g., presses) the report button.”); Claim 5; Figs. 1-5).
Regarding claim 2, Canfield discloses the limitations of claim 1 and further discloses wherein the specialized software system is a browser or a client application (See id. at least at Paras. [0003] (API), [0028]-[0038] (ultrasound specializations that inform the AI model as to the focus and priorities of imaging.); Claim 1; Figs. 1-5).
Regarding claim 3, Canfield discloses the limitations of claim 1 and further discloses wherein the specialized software system is connected to the ultrasound workstation system via a predetermined first communication protocol or a predefined first interface (See id. at least at Paras. [0003], [0028]-[0038], [0088] (communication standards and protocols)).
Regarding claim 4, Canfield discloses the limitations of claim 1 and further discloses wherein obtaining an ultrasound examination task for a patient through the ultrasound workstation system, comprises: when opening a patient report in the ultrasound workstation system, obtaining the ultrasound examination task for the patient based on the patient report (See id. at least at Abstract; Paras. [0003], [0028]-[0038]; Claims 1-13 (“[T]he GUI including a report selector selectable by a user to request a report regarding the examination of the subject and one or more configurable elements for receiving user input from the user.”); Figs. 1-5).
Regarding claim 7, Canfield discloses the limitations of claim 1 and further discloses obtaining patient information or historical examination data of the patient through the ultrasound workstation system; and transmitting the patient information or the historical examination data to the ultrasound device (See id. at least at Abstract; Paras. [0003], [0031]-[0033] (patient data field, HER, other fields), [0077] (medical history and evaluation data regarding ultrasound imaging); Claims 1-13 (“[T]he GUI including a report selector selectable by a user to request a report regarding the examination of the subject and one or more configurable elements for receiving user input from the user.”); Figs. 1-5).
Regarding claim 8, Canfield discloses the limitations of claim 1 and further discloses wherein the specialized software system comprises an obstetric software system, and the obstetric software system provides specialized functions for ultrasound examinations in an obstetric specialty field device (See id. at least at Abstract; Paras. [0003], [0028]-[0036] (“The Type of Exam field 203 identifies the type of examination being performed that produces the ultrasound image data, such as an “obstetric ultrasound exam,” “high risk obstetric ultrasound exam” or a “prenatal ultrasound exam,” for example. This informs the AI driven large language model as to the focus and priorities of the imaging. The Type of Report field 204 indicates the format and detailed content of the response to be output by the AI driven large language model, such as “final report,” “intra-examination report,” or “over-read checklist,” for example […] In an obstetric ultrasound examination, for example, the measurements may include standard fetal measurements, such as biparietal diameter (BPD), occipital-frontal diameter (OFD), head circumference (HC), transcranial Doppler (TCD), transverse abdominal diameter (TAD), anterior-posterior abdominal diameter (APAD), abdominal circumference (AC) 18.96 cm, and femur length (FL), for example.”), [0042], [0077]; Claims 1-13; Figs. 1-5).
Regarding claim 9, Canfield discloses the limitations of claim 8 and further discloses wherein the ultrasound data comprises at least one of: an ultrasound image, fetal measurement data, and a fetal growth chart (See id. at least at Abstract; Paras. [0003], [0028]-[0036] (“The Type of Exam field 203 identifies the type of examination being performed that produces the ultrasound image data, such as an “obstetric ultrasound exam,” “high risk obstetric ultrasound exam” or a “prenatal ultrasound exam,” for example. This informs the AI driven large language model as to the focus and priorities of the imaging. The Type of Report field 204 indicates the format and detailed content of the response to be output by the AI driven large language model, such as “final report,” “intra-examination report,” or “over-read checklist,” for example […] In an obstetric ultrasound examination, for example, the measurements may include standard fetal measurements, such as biparietal diameter (BPD), occipital-frontal diameter (OFD), head circumference (HC), transcranial Doppler (TCD), transverse abdominal diameter (TAD), anterior-posterior abdominal diameter (APAD), abdominal circumference (AC) 18.96 cm, and femur length (FL), for example.”), [0042], [0077]; Claims 1-13; Figs. 1-5).
Regarding claim 10, Canfield discloses the limitations of claim 8 and further discloses transmitting multiple sets of historical fetal measurement data to the ultrasound device, so that the ultrasound device generates a fetal growth chart according to the multiple sets of historical fetal measurement data, wherein the fetal growth chart is used to evaluate fetal growth (See id. at least at Abstract; Paras. [0003], [0028]-[0036] (“The Type of Exam field 203 identifies the type of examination being performed that produces the ultrasound image data, such as an “obstetric ultrasound exam,” “high risk obstetric ultrasound exam” or a “prenatal ultrasound exam,” for example. This informs the AI driven large language model as to the focus and priorities of the imaging. The Type of Report field 204 indicates the format and detailed content of the response to be output by the AI driven large language model, such as “final report,” “intra-examination report,” or “over-read checklist,” for example […] In an obstetric ultrasound examination, for example, the measurements may include standard fetal measurements, such as biparietal diameter (BPD), occipital-frontal diameter (OFD), head circumference (HC), transcranial Doppler (TCD), transverse abdominal diameter (TAD), anterior-posterior abdominal diameter (APAD), abdominal circumference (AC) 18.96 cm, and femur length (FL), for example […] The type of examination (fetal ultrasound) and the actual measurements (BPD 5.94 cm, OFD 7.57 cm, HC 21.33 cm, TCD 2.69 cm, TAD 5.82 cm, APAD 6.35 cm, AC 18.96 cm, and FL 3.86 cm) are in the data set retrieved from the data set provided by ultrasound imaging device 105. The type of standard to employ (Hadlock growth table) is retrieved from device settings, which may be provided to the prompt string generator 116 by the GUI 114, as discussed above, or the data set provided by the ultrasound imaging device 105. , [0042]-[0053] (“These measurements are used to assess fetal growth and development and to monitor for any potential complications. In this case, the measurements appear to be within the expected range for a fetus of 28 weeks and 3 days gestational age.”), [0077]; Claims 1-13; Figs. 1-5).
Regarding claim 11, Canfield discloses the limitations of claim 8 and further discloses obtaining a reference table for evaluating standard fetal growth criteria; and transmitting the reference table to the ultrasound device (See id. at least at Abstract; Paras. [0003], [0028]-[0036] (“The type of examination (fetal ultrasound) and the actual measurements (BPD 5.94 cm, OFD 7.57 cm, HC 21.33 cm, TCD 2.69 cm, TAD 5.82 cm, APAD 6.35 cm, AC 18.96 cm, and FL 3.86 cm) are in the data set retrieved from the data set provided by ultrasound imaging device 105. The type of standard to employ (Hadlock growth table) is retrieved from device settings, which may be provided to the prompt string generator 116 by the GUI 114, as discussed above, or the data set provided by the ultrasound imaging device 105. , [0042]-[0053] (“These measurements are used to assess fetal growth and development and to monitor for any potential complications. In this case, the measurements appear to be within the expected range for a fetus of 28 weeks and 3 days gestational age.”), [0077]; Claims 1-13; Figs. 1-5).
Regarding claim 12, claim 12 recites substantially the same limitations included in independent claim 1 and is rejected under the same grounds of rejection and for the same reasoning as applied to claim 1, above.
Regarding claims 15-19, claims 15-19 recite substantially the same limitations included in claims 7-11, respectively, and are rejected under the same grounds of rejection and for the same reasoning as applied to claims 7-11, above.
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 filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 5-6, 13-14 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Canfield, in view of U.S. 2019/0015080 A1 to Kreuzer, hereinafter “Kreuzer.”
Regarding claim 5, Canfield discloses the limitations of claim 4. Canfield may not specifically describe but Kreuzer teaches wherein obtaining the ultrasound examination task for the patient based on the patient report, comprises: capturing a screenshot of the patient report; identifying identification information about the patient from a content of the screenshot; and querying the ultrasound examination task for the patient from a task worklist based on the identification information. (See Kreuzer at least at Paras. [0002]-[0006] (a screen shot of an exemplary DICOM modality worklist used to illustrate an embodiment), [0029]-[0042] (“the study scheduling server 160 can send a DICOM modality worklist to the medical diagnostic ultrasound imaging system 100 for display on the display device 260, 270. (While a worklist can be locally stored on the medical diagnostic ultrasound imaging system 100, having the study scheduling server 160 send a DICOM modality worklist to the medical diagnostic ultrasound imaging system 100 can provide department-wide uniformity […] FIG. 4 is a screen shot of an exemplary DICOM modality worklist used to illustrate this embodiment. While a DICOM modality worklist is used in this example, it should be understood that other types of scheduled-patient lists or displays can be used. In general, a DICOM modality worklist is list of imaging procedures scheduled for the medical diagnostic ultrasound imaging system 100. As shown in FIG. 4, the DICOM modality worklist in this example includes patient name, patient medical number, reason for study, and study date and time. Other or different information can be displayed, such as, but not limited to, sex, age, the type of procedure, equipment type, procedure order, and referring physician. In operation, the sonographer selects the displayed line for the patient being examined and then presses a real or virtual “Start Study” button, which starts the ultrasound examination.”); Figs. 2, 4).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the disclosure of Canfield to incorporate the teachings of Kreuzer and provide a screenshot of a patient report and worklist to an ultrasound device Kreuzer is directed to a medical diagnostic ultrasound system for receiving information from a server during an examination. Incorporating the ultrasound examination and communication techniques with the system for generating a report for ultrasound imaging as in Canfield would thereby improve the applicability and efficacy of ultrasound examination for patients and providers.
Regarding claim 6, Canfield discloses the limitations of claim 4 and further teaches wherein obtaining the ultrasound examination task for the patient based on the patient report, comprises: obtaining identification information inputted by a user, which information is displayed on the patient report (See Canfield at least at Abstract; Paras. [0003], [0028]-[0038]; Claims 1-13 (“[T]he GUI including a report selector selectable by a user to request a report regarding the examination of the subject and one or more configurable elements for receiving user input from the user.”); Figs. 1-5). Canfield may not specifically describe but Kreuzer teaches querying the ultrasound examination task for the patient from a task worklist based on the identification information (See Kreuzer at least at Paras. [0002]-[0006] (a screen shot of an exemplary DICOM modality worklist used to illustrate an embodiment), [0029]-[0042] (“the study scheduling server 160 can send a DICOM modality worklist to the medical diagnostic ultrasound imaging system 100 for display on the display device 260, 270. (While a worklist can be locally stored on the medical diagnostic ultrasound imaging system 100, having the study scheduling server 160 send a DICOM modality worklist to the medical diagnostic ultrasound imaging system 100 can provide department-wide uniformity […] FIG. 4 is a screen shot of an exemplary DICOM modality worklist used to illustrate this embodiment. While a DICOM modality worklist is used in this example, it should be understood that other types of scheduled-patient lists or displays can be used. In general, a DICOM modality worklist is list of imaging procedures scheduled for the medical diagnostic ultrasound imaging system 100. As shown in FIG. 4, the DICOM modality worklist in this example includes patient name, patient medical number, reason for study, and study date and time. Other or different information can be displayed, such as, but not limited to, sex, age, the type of procedure, equipment type, procedure order, and referring physician. In operation, the sonographer selects the displayed line for the patient being examined and then presses a real or virtual “Start Study” button, which starts the ultrasound examination.”); Figs. 2, 4).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the disclosure of Canfield to incorporate the teachings of Kreuzer and provide querying an ultrasound task from a worklist. Kreuzer is directed to a medical diagnostic ultrasound system for receiving information from a server during an examination. Incorporating the ultrasound examination and communication techniques with the system for generating a report for ultrasound imaging as in Canfield would thereby improve the applicability and efficacy of ultrasound examination for patients and providers.
Regarding claims 13-14, claims 13-14 recite substantially the same limitations included in claims 5-6, respectively, and are rejected under the same grounds of rejection and for the same reasoning as applied to claims 5-6, above.
Regarding claim 20, Canfield discloses the limitations of claim 12. Canfield may not specifically describe but Kreuzer teaches the ultrasound workstation system inserting the ultrasound data and the examination result into the patient report; and the ultrasound workstation system uploading the patient report to an electronic medical record system when the patient report has been approved (See Kreuzer at least at Paras. [0023] (bi-directional communication with server and EMR systems and workstations.), [0042]-[0045]; Figs. 1-2, 4, 7-12, 15).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the disclosure of Canfield to incorporate the teachings of Kreuzer and provide a uploading information to an EMR. Kreuzer is directed to a medical diagnostic ultrasound system for receiving information from a server during an examination. Incorporating the ultrasound examination and communication techniques with the system for generating a report for ultrasound imaging as in Canfield would thereby improve the applicability and efficacy of ultrasound examination for patients and providers.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: U.S. 2026/0053475 A1 to Utsunomiya et al., U.S. 2022/0095999 A1 to Kayser et al.
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/WILLIAM T. MONTICELLO/Examiner, Art Unit 3682
/FONYA M LONG/Supervisory Patent Examiner, Art Unit 3682
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