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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 6/8/2026 has been entered.
Response to Arguments
A. Applicant's arguments with respect to the rejection of claims 1 and 3-21 under 35 USC 101 have been fully considered but they are not persuasive.
Applicant argues starting on page 12 of the response that claim 1 is not directed merely to entering answers into a worksheet, and recites a specific ultrasound reporting system. Applicant cites to limitations in claim 1 including receiving, via the display device, a user selection of an auto-populating feature to enable auto-population of the medical worksheet with worksheet data based on the mapping, determining, during the ultrasound examination, the saving the first ultrasound image in the memory responsive to said receive, determine, using the mapping, the first worksheet answer indicating that the first view of the patient's anatomy has been obtained responsive to the saving the first ultrasound image in the memory, and automatically populating, during the ultrasound examination, the medical worksheet with the first worksheet answer indicating that the first view of the patient's anatomy has been obtained. Applicant asserts that “Thus, the claim is directed to detecting internal system-level events within an ultrasound system-namely, saving ultrasound images in memory-and programmatically triggering reporting operations based on those events.” Examiner respectfully disagrees.
With respect to Applicant’s assertion that the claim is directed to “detecting internal system-level events… namely, saving ultrasound images in memory,” the use of the memory to save the ultrasound image is not construed as falling within the scope of the abstract idea as set out below in Step 2A Prong 2 of the rejection. While Applicant asserts that the claim requires an “internal machine-level operation that is not directly perceptible to, nor practically performable by, a human operator,” Examiner maintains that the function of the memory within the element of “saving ultrasound images in memory, is that of storing the ultrasound image. Examiner respectfully disagrees that characterizing the act of storing the image as saving it “in memory” requires that the function of determining that the ultrasound image has been saved be exclusively performed via “internal machine-level operation that is not directly perceptible to, nor practically performable by, a human operator.” By Applicant’s own statement on page 14, “[a] human user may observe that an image has been captured.” Furthermore, the claim does not require directly detecting a memory write event beyond determining that the image has been saved. As noted above, the use of the memory to store the mapping is not construed as part of the abstract idea, and only amounts to instructions to use a memory to store the mapping data.
Applicant further argues on page 15 that “[t]he claimed invention is not directed to automating a known manual process, such as a clinician manually checking boxes on a worksheet,” and instead recites “a specific event-driven system architecture in which: internal ultrasound-system events (e.g., saving ultrasound images in memory) are detected during image acquisition…”. Examiner respectfully disagrees. As noted above, the use of a memory to save the ultrasound image is not construed as falling with the scope of the abstract idea. The claim recites “determin[ing], during the ultrasound examination, the saving the first ultrasound image in the memory,” i.e. the determination is made based on the act of saving of the ultrasound image, with the memory being used to implement the actual storage. The claim does not recite further operations exclusively internal to the memory are required for this function.
Examiner additionally respectfully disagrees that the claim recites an improvement in technology. Applicant asserts that “[i]nstead of relying on user observation and manual entry, the system programmatically couples image acquisition with reporting. As a result: reporting is performed in real time during the ultrasound examination, manual interaction is reduced, and the system can automatically indicate that required anatomical views have been obtained.” However, “programmatically coupl[ing] image acquisition with reporting,” “reducing” manual interaction, and “automatically indicat[ing] that required anatomical views have been obtained” are all characterizations compatible with Examiner’s assertion that the claim recites the use of computers to automate the manual process of entering worksheet answers.
Applicant further argues that claim 1 is integrated into a practical application on the basis that it recites limitations which tie the claimed subject matter to a particular medical imaging technology and real-world clinical application.” Examiner respectfully disagrees. Applicant specifically states that the claim is integrated into the practical application of “ultrasound reporting system operating during an ultrasound examination that receives, via the display device, a user selection of an auto-populating feature to enable auto-population of the medical worksheet with worksheet data based on the mapping; detection of image-save events in system memory; automatic population of medically relevant worksheet fields corresponding to anatomical views during the examination; and displaying the medical worksheet on the display device.” However, the additional elements cited by Applicant such as the display device and memory only amount to mere instructions to implement the abstract idea using computing elements as tools. Populating worksheet fields during an ultrasound examination based on images being captured falls within the scope of the abstract idea, and the use of memory to store the images and a display device to display the worksheet only amount to mere instructions to implement as stated above.
Applicant argues starting on page 17 that claim 1 recites limitations amounting to significantly more than the abstract idea, citing “detection of internal system events associated with saving ultrasound images in memory, use of a mapping stored in memory linking those events to worksheet answers, and automatic population of worksheet fields during the examination based on the detected events.” Examiner respectfully disagrees. Similarly to as noted above, Examiner disagrees with Applicant’s characterization of the claim as requiring “detection of internal system events associated with saving ultrasound images in memory.” Claim 1 recites determining that an ultrasound image has been saved in memory. A human is capable of observing that an image has been captured, and Examiner maintains that the memory is being used to implement the function of storing the image. The claim does not further recite “internal system events” beyond the use of the memory to store the image. With respect to Applicant’s assertion that Examiner has not provided evidence that this specific combination is well-understood routine and conventional activity, Examiner notes that the memory and its use within the context of the claim as a whole is construed as mere instructions to implement the abstract idea, not as insignificant extra-solution activity. Examiner maintains that a further analysis under Berkheimer is not required given that no elements are construed as insignificant extra-solution activity.
Applicant presents arguments with respect to claim 11, starting on page 18. Applicant argues that Examiner’s interpretation of the abstract idea is incomplete and asserts that the claim recites a specific ultrasound reporting system. Applicant asserts that “the claim is directed to processing ultrasound image data to detect a clinically meaningful condition (free fluid exceeding a threshold) and automatically generating structured reporting data based on that detection.” Examiner respectfully disagrees. Initially, Examiner notes that most of the limitations cited by Applicant are characterized as falling within the abstract idea, including
determining, during the ultrasound examination, the first threshold condition indicating that the amount of free fluid is greater than the threshold amount responsive to said receive, determining from the mapping, the first worksheet question on the medical worksheet about whether or not the ultrasound image indicates the free fluid corresponding to said indication that the amount of free fluid is greater than the threshold amount; and populating, during the ultrasound examination and responsive to the determination of the first worksheet question, a first worksheet answer field on the medical worksheet with the first worksheet answer indicating the presence of free fluid in the ultrasound image wherein a second worksheet answer field on the medical worksheet is populated with the second worksheet answer indicating one of the absence of free fluid or the fluid indeterminate when the first threshold condition is not determined. As set out below, a human is capable of determining whether an amount of free fluid in an ultrasound image exceeds a threshold and entering an answer into a worksheet indicating this fact “in real time.” The elements including the processing system itself and the memory only amount to instructions to implement functions such as data storage using computing elements.
This further applies to Applicant’s assertions that claim 11 recites “determining satisfaction of a threshold condition in an ultrasound image, specifically that an amount of free fluid exceeds a threshold,” and that “[t]his determination is based on processing ultrasound image data, not mere visual inspection or human judgment as recited.” Examiner notes that a human is capable of determining an amount of free fluid present in an ultrasound image, and the claim does not recite any specific processing of ultrasound image data beyond making that determination. Examiner likewise maintains that a human performing an ultrasound examination is capable of evaluating a quantitative threshold condition from ultrasound image data, and populating a worksheet answer mapped to a question. The use of a computer to “programmatically trigger” the populating of the worksheet only amounts to use of the computer to automate the process.
Applicant further argues that the claim “reflects a technological improvement, not mere automation.” Examiner respectfully disagrees. Applicant asserts that “[t]he claimed invention is not directed to automating a known manual process… A manual process would require a clinician to: visually inspect ultrasound images, subjectively determine whether free fluid is present, and manually enter a corresponding answer.” Examiner notes that the claim recites elements of determining whether free fluid is present in ultrasound images as well as entering a corresponding answer, and that a human is capable of visually inspecting the images as acknowledged by Applicant. A general assertion that the use of computers to perform processes such as analyzing the ultrasound image data and populating the worksheet is not sufficient to establish that the claim does not recite elements falling within the scope of an abstract idea.
Applicant argues on page 22 that claim 11 is “limited to a specific technological context and as a whole is integrated into the practical application of: an ultrasound reporting system, processing of ultrasound images obtained during an examination, and determining a clinically meaningful imaging condition (free fluid exceeding a threshold), followed by automatically populating a medical worksheet during the examination; and displaying the medical worksheet on the display device.” Examiner respectfully disagrees.
Examiner maintains that the elements of processing ultrasound images obtained during an examination, determining a clinically meaningful imaging condition (free fluid exceeding a threshold), populating a medical worksheet during the examination, and displaying the medical worksheet fall within the scope of the abstract idea as elements of managing personal behavior of a human. The additional elements, such as the display device used to display the worksheet and use of processors to implement automatic population of the worksheet answer, only amount to mere instructions to implement the respective functions using computing elements, and are not sufficient to integrate the abstract idea into a practical application.
The same rationale substantially applies to Applicant’s arguments on pages 22 and 23 that claim 11 recites significantly more than the abstract idea. Applicant asserts that claim 11 recites “an ultrasound reporting system operating during an ultrasound examination that receives, via the display device, a user selection of an auto-populating feature to enable auto-population of the medical worksheet with worksheet data based on the mapping, determines a threshold condition in ultrasound image data, maps that condition to a corresponding worksheet question and answer, automatically populates a worksheet during the examination in response to the detected condition; and displaying the medical worksheet on the display device.”
With respect to Applicant’s assertion that Examiner has not provided evidence that this specific combination is well-understood routine and conventional activity, Examiner again notes that the additional elements such as the display device and components of the ultrasound system itself are construed as mere instructions to implement the respective functions within the abstract idea, not as insignificant extra-solution activity. Examiner maintains that a further analysis under Berkheimer is not required given that no elements are construed as insignificant extra-solution activity. The other elements, such as determining a threshold condition based on the ultrasound image data, mapping the worksheet question and answer, and populating the worksheet fall within the scope of the abstract idea itself.
The rejection under 35 USC 101 is maintained.
B. Applicant's arguments with respect to the rejection of claims 1, 4-6, 11, 15, 17-18, and 21 under 35 USC 102 have been fully considered and are persuasive. However, upon further consideration, claims 1, 4-6, 9, 17, and 21 are now rejected under 35 USC 103 over Hare II et al (US Patent Application Publication 2021/0259664) (hereinafter Hare) in view of McLeod (US Patent Application Publication 2022/0280133), with claim 18 rejected further in view of Torres et al (US Patent Application Publication 2020/0111553).
Applicant argues on page 24 that Hare fails to disclose “a memory configured to store a mapping of system events including a first system event of saving a first ultrasound image in the memory and worksheet answers including a first worksheet answer indicating that a first view of a patient's anatomy has been obtained for a medical worksheet to report an ultrasound examination of the patient's anatomy according to a medical protocol, the medical worksheet comprising a first worksheet question about whether or not the first view of the patient's anatomy has been obtained that is associated with the first worksheet answer” as recited in claim 1. Examiner respectfully disagrees.
As cited below, Figures 22A-E, in conjunction with paragraphs 198, 207, 209, 211, 213, 216, and 218 of Hare describe a plurality of view types to be captured as part of defined ultrasound workflow protocols as well as thresholds, which when exceeded, indicate that the corresponding view has been captured, i.e. system events mapped to worksheet answers. Figures 22A and 22E and paragraphs 43, 211, 213, and 216 additionally describe capturing an ultrasound image upon determining that the view is acceptable and populating a checkmark indicating this in the workflow list. Figures 22B-22E show a worksheet having a list of views to be collected and answers in the form of checkmarks next to a view when it is captured. For clarity of record Examiner notes that the scope of a “worksheet question” and “worksheet answer” has been interpreted in light of Figure 2B and paragraphs 58 and 68 of Applicant’s disclosure, where populating an affirmative response, such as a checkmark, next to a listed view is described as a question and answer.
Applicant provides no specific arguments addressing why Hare fails to teach the argued limitations.
In response to Applicant's further arguments on pages 25-32 against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
While Applicant asserts on pages 32 and 33 that all of the cited references in combination fail to teach all of the limitations of claim 1, Applicant provides no arguments in support of this assertion. Examiner refers Applicant to the rejection of claim 1 below.
With respect to Applicant’s argument that the cited references do not teach all of the limitations of claim 11, Examiner notes that claim 11 is not presently rejected in light of the prior art of record.
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 and 3-21 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. Claims 1, 3-10, and 21, claims 11-16, and claims 17-20 are drawn to respective systems, each of which is within the four statutory categories.
Step 2A(1)
Independent claim 1 recites, in part, performing the steps of:
storing a mapping of system events including a first system event of saving a first ultrasound image and worksheet answers including a first worksheet answer indicating that a first view of a patient's anatomy has been obtained for a medical worksheet to report an ultrasound examination of the patient's anatomy according to a medical protocol, the medical worksheet comprising a first worksheet question about whether or not the first view of the patient's anatomy has been obtained that is associated with the first worksheet answer;
receiving a user selection of an auto-populating feature to enable auto-population of the medical worksheet with worksheet data based on the mapping;
determining, during the ultrasound examination, the saving the first ultrasound image responsive to said receive;
determining, using the mapping, the first worksheet answer indicating that the first view of the patient’s anatomy has been obtained responsive to the saving the first ultrasound image; and
populating, during the ultrasound examination the medical worksheet with the first worksheet answer indicating that the first view of the patient’s anatomy has been obtained, wherein the medical worksheet is not populated when the saving of the first ultrasound image is not determined; and
display the medical worksheet.
These steps amount to a form of managing personal behavior and therefore fall within the scope of an abstract idea in the form of a method of organizing human activity. Fundamentally the process is that of, during an ultrasound examination, determining that a first view of a patient’s anatomy has been obtained based on an ultrasound image being saved, determining a worksheet question pertaining to whether the view has been captured and a corresponding answer, and entering the answer indicating that the view of the patient’s anatomy has been obtained. This constitutes a management of the behavior of an individual, such as a clinician performing the ultrasound examination, as part of performing and recording results of the examination. Examiner notes Figures 2B as well as Figures 3 and 4 of Applicant’s disclosure, in which the worksheet questions and answers may simply be manually entered by a user as further described in paragraph 58 of the specification.
Independent claim 11 recites, in part, performing the steps of:
storing a mapping of threshold conditions including a first threshold condition indicating that an amount of free fluid is greater than a threshold amount for an ultrasound image obtained at an ultrasound examination of a patient’s anatomy and worksheet questions including a first worksheet question about whether or not the ultrasound image indicates the free fluid for a medical worksheet to report the ultrasound examination of the patient’s anatomy according to a medical protocol, wherein the first worksheet question is associated with a plurality of worksheet answers including a first worksheet answer that the free fluid is present and a second worksheet answer that the free fluid is absent in the ultrasound image,;
receiving a user selection of an auto-populating feature to enable auto-population of the medical worksheet with worksheet data based on the mapping;
determining, during the ultrasound examination, the first threshold condition indicating that the amount of free fluid is greater than the threshold amount responsive to said receive;
determining from the mapping, the first worksheet question on the medical worksheet about whether or not the ultrasound image indicates the free fluid corresponding to said indication that the amount of free fluid is greater than the threshold amount; and
populating, during the ultrasound examination and responsive to the determination of the first worksheet question, a first worksheet answer field on the medical worksheet with the first worksheet answer indicating the presence of free fluid in the ultrasound image, wherein a second worksheet answer field on the medical worksheet is populated with the second worksheet answer indicating one of the absence of free fluid or the fluid indeterminate when the first threshold condition is not determined; and
displaying the medical worksheet.
These steps amount to a form of managing personal behavior and therefore fall within the scope of an abstract idea in the form of a method of organizing human activity. Fundamentally the process is that of, during an ultrasound examination, determining that an amount of free fluid indicated by an ultrasound image exceeds a threshold, determining a worksheet question about whether or not the ultrasound image indicates the free fluid, and entering an answer of either free fluid being present or absent based on whether the amount of free fluid in the ultrasound image exceeds or does not exceed the threshold. This constitutes a management of the behavior of an individual, such as a clinician performing the ultrasound examination, as part of performing and recording results of the examination. Examiner notes Figures 2B as well as Figures 3 and 4 of Applicant’s disclosure, in which the worksheet questions and answers may simply be manually entered by a user as further described in paragraph 58 of the specification.
Independent claim 17 recites, in part, performing the steps of:
storing a mapping of system events including a first system event of saving a first ultrasound image and worksheet answers including a first worksheet answer indicating that a first view of a patient's anatomy has been obtained for a medical worksheet to report an ultrasound examination of the patient's anatomy according to a medical protocol;
receive a user selection of an auto-populate feature to enable auto-population of the medical worksheet with worksheet data based on the mapping of the system events and the worksheet answers;
accessing a dictionary of worksheet questions comprising a first worksheet question about whether or not the first view of the patient's anatomy has been obtained associated with the worksheet answers comprising the first worksheet answer for the ultrasound examination;
determining, during the ultrasound examination, the saving the first ultrasound image responsive to said receive; and
generating, using the mapping, a clinical result that includes the first worksheet answer indicating that the first view of the patient's anatomy has been obtained in response to the saving the first ultrasound image;
populate, during the ultrasound examination, the medical worksheet with the first worksheet answer indicating that the first view of the patient's anatomy has been obtained, wherein the medical worksheet is not populated when the saving of the first ultrasound image is not determined; and
display the medical worksheet.
These steps amount to a form of managing personal behavior and therefore fall within the scope of an abstract idea in the form of a method of organizing human activity. Fundamentally the process is that of, during an ultrasound examination, determining that a first view of a patient’s anatomy has been obtained based on an ultrasound image being saved, determining a worksheet question pertaining to whether the view has been captured and a corresponding answer, and entering the answer indicating that the view of the patient’s anatomy has been obtained. This constitutes a management of the behavior of an individual, such as a clinician performing the ultrasound examination, as part of performing and recording results of the examination. Examiner notes Figures 2B as well as Figures 3 and 4 of Applicant’s disclosure, in which the worksheet questions and answers may simply be manually entered by a user as further described in paragraph 58 of the specification.
Step 2A(2)
This judicial exception is not integrated into a practical application because the additional elements within the claims only amount to:
A. Instructions to Implement the Judicial Exception. MPEP 2106.05(f)
Claim 1 recites the additional elements of a) a memory recited as storing the mapping as well as the ultrasound image, b) a display device coupled to the memory and used to receive the user selection and display the worksheet, and c) a processor system recited as coupled to the memory and the display device and used to implement a reporting application at least partially in hardware, where the reporting application is recited as used to implement the subsequent steps.
Claim 11 recites the additional elements of a) a processing system recited as executing stored instructions to implement a reporting application, where the reporting application is recited as used to implement the subsequent steps, b) a display device coupled to the processing system and used to receive the user selection and display the worksheet, and c) a non-transitory computer readable storage medium recited as used to store the instructions as well as the mapping.
Claim 17 recites the additional elements of a) a memory recited as storing the mapping as well as the dictionary of questions and the ultrasound image, b) a processing system recited as executing stored instructions to implement a reporting application, where the reporting application is recited as used to implement the subsequent steps, c) a display device coupled to the processing system and used to receive the user selection and display the worksheet, and d) a computer readable storage medium recited as used to store the instructions.
Paragraphs 99 and 100 describe a computing device “that may perform one or more of the operations described herein, in accordance with some embodiments.” Paragraphs 100 and 102 describe the computing device as including a processing device which “may be provided by one or more general-purpose processing devices such as a microprocessor, central processing unit, or the like,” and a memory such as DRAM, ROM, or flash memory. Paragraphs 73, 78, and 81 similarly describe the functions as performed by a processing system implementing a reporting application, which is described as processing logic comprising software run on a general-purpose computing system. Paragraphs 44-46 describe a workflow including storing an image in a memory, but do not further specify the particular memory. The memory used to store the image is construed as encompassing the types of memory described above. Each of the memory, processor system, processing system, non-transitory computer readable medium, and reporting application is therefore construed as encompassing generic computing elements.
Paragraph 101 describes the computing device as including a display unit, which may include an LCD, CRT, or touchscreen, while paragraph 75 describes displaying the portion of the medical worksheet “automatically and without user intervention”. The display device is accordingly construed as encompassing generic display devices.
The above elements amount to mere instructions to implement the abstract idea using computing elements as tools. For example, each of the memory and non-transitory computer readable medium is recited at a high level of generality as storing data while being disclosed as any of a plurality of general-purpose memory types, and the display device, processing system, and processor system are likewise recited at a high level of generality as receiving user input and implementing an application to perform the subsequent data processing functions. These elements are therefore not sufficient to integrate the abstract idea into a practical application.
The above claims, as a whole, are therefore directed to an abstract idea.
Step 2B
The present claims do not include additional elements that are sufficient to amount to more than the abstract idea because the additional elements or combination of elements amount to no more than a recitation of:
A. Instructions to Implement the Judicial Exception. MPEP 2106.05(f)
As explained above, claims 1, 11, and 17 only recite the memory, non-transitory computer readable medium, processor system, processing system, and application as tools for performing the steps of the abstract idea, and mere instructions to perform the abstract idea using a computer is not sufficient to amount to significantly more than the abstract idea. MPEP 2106.05(f)
Thus, taken alone, the additional elements do not amount to significantly more than the above-identified judicial exception. Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually.
Depending Claims
Claim 3 recites wherein the mapping of the system events is user-defined and includes the first worksheet question that is answered by the first worksheet answer. These limitations fall within the scope of the abstract idea as set out above.
Claim 4 recites determining, during the ultrasound examination, that the ultrasound examination implements a step of a protocol, and wherein the displaying a portion of the medical worksheet that corresponds to the step of the protocol. These limitations fall within the scope of the abstract idea as set out above.
Claim 4 further recites the additional elements of a) a neural network implemented at least partially in hardware recited as used to determine the implementation of the step of the protocol, and b) the display device used to display the portion of the medical worksheet automatically and without user intervention.
Paragraphs 59, 71, and 75 among others describe a neural network being used to determine that the ultrasound examination implements a step of the protocol, such as by determining an anatomy being imaged. However, no further disclosure is provided of the neural network itself. The neural network is construed as encompassing any neural network algorithm implemented in hardware/software.
Paragraph 101 describes the computing device as including a display unit, which may include an LCD, CRT, or touchscreen, while paragraph 75 describes displaying the portion of the medical worksheet “automatically and without user intervention” in the same language used in the claim. The display device is accordingly construed as encompassing generic display devices, while “automatically and without user intervention” is construed as using the display generic computing elements disclosed with respect to the processing system and computer readable medium.
These elements amount to mere instructions to implement functions within the abstract idea using computing elements as tools. As noted above, the neural network is only recited at a high level of generality as used to perform the function of determining whether the examination implements a particular protocol step, and is not further disclosed in the specification or drawings. The display device is likewise recited at a high level of generality and disclosed broadly, while “automatically and without user intervention” encompasses performance using the generic computing elements of the system. These elements are therefore not sufficient to integrate the abstract idea into a practical application or to amount to significantly more than the abstract idea.
Claim 5 recites display the portion of the medical worksheet that corresponds to the step of the medical protocol including not to display other portions of the medical worksheet that do not correspond to the step of the protocol. These limitations fall within the scope of the abstract idea as set out above.
Claim 5 further recites the additional element of a display device used to display the portion of the medical worksheet.
Paragraph 101 describes the computing device as including a display unit, which may include an LCD, CRT, or touchscreen. The display device is accordingly construed as encompassing generic display devices.
The use of a display device to display the step of the protocol amounts to mere instructions to implement functions within the abstract idea using computing elements as tools. The display device is recited at a high level of generality as used to display the protocol step, and is disclosed broadly. This element is therefore not sufficient to integrate the abstract idea into a practical application or to amount to significantly more than the abstract idea.
Claim 6 recites maintaining a protocol, determining, based on the first system event corresponding to a current protocol step of the protocol, a next protocol step of the protocol, and displaying a portion of the medical worksheet that corresponds to the next protocol step. These limitations fall within the scope of the abstract idea as set out above.
Claim 6 further recites the additional elements of a) the display device used to display the portion of the medical worksheet, b) the memory used to maintain the protocol, and c) the reporting application used to determine the next step of the protocol.
Paragraph 101 describes the computing device as including a display unit, which may include an LCD, CRT, or touchscreen. The display device is accordingly construed as encompassing generic display devices.
Paragraphs 76 and 100-103 describe a memory such as DRAM, ROM, or flash memory, as well as the memory “maintaining” a protocol. Paragraphs 73, 78, and 81 similarly describe functions as performed by a processing system implementing a reporting application, which is described as processing logic comprising software run on a general-purpose computing system. Each of the memory and reporting application is therefore construed as encompassing generic computing elements.
These elements amount to mere instructions to implement functions within the abstract idea using computing elements as tools. As noted above, each of the display device, memory, and reporting application are recited at a high level of generality as used to implement data processing and storage tasks and are disclosed broadly in the specification. These elements are therefore not sufficient to integrate the abstract idea into a practical application or to amount to significantly more than the abstract idea.
Claim 7 recites maintaining orders of steps of the protocol based on operator identifications,
determining an operator identification for an operator performing the ultrasound examination, and the determination of the next protocol step is based on the operator identification, the current protocol step, and the orders of steps of the protocol. These limitations fall within the scope of the abstract idea as set out above.
Claim 7 further recites the additional elements of a) the memory used to maintain the order of steps of the protocol, and b) the reporting application used to determine the operator identification.
Paragraphs 76 and 100-103 describe a memory such as DRAM, ROM, or flash memory, as well as the memory “maintaining” a protocol. Paragraphs 73, 78, and 81 similarly describe functions as performed by a processing system implementing a reporting application, which is described as processing logic comprising software run on a general-purpose computing system. Each of the memory and reporting application is therefore construed as encompassing generic computing elements.
These elements amount to mere instructions to implement functions within the abstract idea using computing elements as tools. As noted above, the memory and reporting application are recited at a high level of generality as used to implement data processing and storage tasks and are disclosed broadly in the specification. These elements are therefore not sufficient to integrate the abstract idea into a practical application or to amount to significantly more than the abstract idea.
Claim 8 recites maintaining orders of steps of the medical protocol based on operator identifications; determining an operator identification for an operator of the ultrasound machine; determining, based on the operator identification and the orders of steps of the medical protocol, a step in the medical protocol; and configuring the ultrasound machine for the step in the protocol. These limitations fall within the scope of the abstract idea as set out above.
Claim 8 further recites the additional elements of a) an ultrasound machine implemented to perform the ultrasound examination, b) the memory used to maintain the order of steps of the protocol, and c) the reporting application used to determine the operator identification and the step in the protocol.
Paragraph 44 provides that “[i]n some embodiments, the process is performed by one or more processors of a computing device such as, for example, but not limited to, an ultrasound machine with an ultrasound imaging subsystem.” Paragraph 77 further reflects the language of the claim, stating that “[i]n some embodiments, the ultrasound reporting system includes an ultrasound machine implemented to perform the ultrasound examination.” The ultrasound machine is construed as encompassing a generic ultrasound machine capable of performing an ultrasound examination.
Paragraphs 76 and 100-103 describe a memory such as DRAM, ROM, or flash memory, as well as the memory “maintaining” a protocol. Paragraphs 73, 78, and 81 similarly describe functions as performed by a processing system implementing a reporting application, which is described as processing logic comprising software run on a general-purpose computing system. Each of the memory and reporting application is therefore construed as encompassing generic computing elements.
These elements amount to mere instructions to implement functions within the abstract idea using computing elements as tools. As noted above, the memory and reporting application are recited at a high level of generality as used to implement data processing and storage tasks and are disclosed broadly in the specification. The ultrasound machine is recited at a high level of generality as “implemented to perform the ultrasound examination,” and is disclosed broadly as an ultrasound machine with an imaging subsystem. In the context of the claim as a whole, the ultrasound machine is merely recited as a tool for performing the ultrasound examination. These elements are therefore not sufficient to integrate the abstract idea into a practical application or to amount to significantly more than the abstract idea.
Claim 9 recites receiving a user selection of a worksheet display feature; and display the medical worksheet based on the user selection. These limitations fall within the scope of the abstract idea as set out above.
Claim 9 further recites the additional element of the reporting application as used to receive the user selection.
Paragraphs 73, 78, and 81 describe functions as performed by a processing system implementing a reporting application, which is described as processing logic comprising software run on a general-purpose computing system. The reporting application is therefore construed as encompassing generic computing elements such as software.
The recitation of a reporting application to receive the user selection amounts to mere instructions to implement functions within the abstract idea using computing elements as tools. As noted above, the reporting application is recited at a high level of generality as used to receive the user selection, i.e. to receive user input, and is disclosed broadly in the specification. The use of an application to receive input from a user is not sufficient to integrate the abstract idea into a practical application or to amount to significantly more than the abstract idea.
Claim 10 recites maintaining the medical protocol for the ultrasound examination, and obtaining the medical protocol. These limitations fall within the scope of the abstract idea as set out above.
Claim 10 further recites the additional elements of a) the memory used to maintain the protocol, b) the reporting application used to obtain the protocol, and c) an ultrasound machine recited as providing the protocol.
Paragraphs 76 and 100-103 describe a memory such as DRAM, ROM, or flash memory, as well as the memory “maintaining” a protocol. Paragraphs 73, 78, and 81 similarly describe functions as performed by a processing system implementing a reporting application, which is described as processing logic comprising software run on a general-purpose computing system. Each of the memory and reporting application is therefore construed as encompassing generic computing elements.
Paragraph 62 provides that “[i]n some embodiments, the system includes a computing device, such as an ultrasound machine, that can obtain protocols for ultrasound examinations from other computing devices, such as another ultrasound machine,” and that “the computing device can import protocols from other machines and export protocols to the other machines.” Given the breadth and context in which the ultrasound machine is recited in the claim, the ultrasound machine is construed as encompassing a generic ultrasound machine having a memory.
These elements amount to mere instructions to implement functions within the abstract idea using computing elements as tools. As noted above, the memory and reporting application are recited at a high level of generality as used to implement data processing and storage tasks and are disclosed broadly in the specification. The ultrasound machine is also recited at a high level of generality in which the protocol is merely recited as obtained “from an ultrasound machine” and is disclosed broadly as an ultrasound machine which can store a protocol. In the context of the claim as a whole, the ultrasound machine is only recited as a storage device which provides the protocol. These elements are therefore not sufficient to integrate the abstract idea into a practical application or to amount to significantly more than the abstract idea.
Claim 12 recites wherein the medical worksheet comprises a third worksheet answer associated with the first worksheet question, the third worksheet answer indicating the presence of free fluid in the ultrasound image is indeterminate. These limitations fall within the scope of the abstract idea as set out above.
Claim 13 recites wherein the mapping includes a third threshold condition that includes an image quality, and a third worksheet answer field that includes at least one of an image quality score, an indication of an anatomy in an ultrasound image, and an indication of an interventional instrument in the ultrasound image. These limitations fall within the scope of the abstract idea as set out above.
Claim 14 recites wherein the mapping is a user-defined mapping of threshold conditions to questions on the medical worksheet, and the determination of the question is based on the user-defined mapping. These limitations fall within the scope of the abstract idea as set out above.
Claim 15 recites wherein the determination of the first threshold condition is during a current step of the protocol, and determining the first worksheet question as part of the current step of the protocol. These limitations fall within the scope of the abstract idea as set out above.
Claim 15 further recites the additional element of the reporting application as implemented to determine the first worksheet question.
Paragraphs 80 and 81 describe functions as performed by a processing system implementing a reporting application, which is described as processing logic comprising software run on a general-purpose computing system. The reporting application is therefore construed as encompassing generic computing elements such as software.
The recitation of the reporting application amounts to mere instructions to implement functions within the abstract idea using computing elements as tools. Specifically, the reporting application is recited at a high level of generality as implemented to perform the data processing function of determining the question, and is disclosed broadly in the specification. The reporting application is therefore not sufficient to integrate the abstract idea into a practical application or to amount to significantly more than the abstract idea.
Claim 16 recites wherein the determination of the first threshold condition is during a current step of the protocol, and determining the first worksheet question as part of a protocol step different from the current step of the protocol. These limitations fall within the scope of the abstract idea as set out above.
Claim 16 further recites the additional element of the reporting application as implemented to determine the first worksheet question.
Paragraphs 80 and 81 describe functions as performed by a processing system implementing a reporting application, which is described as processing logic comprising software run on a general-purpose computing system. The reporting application is therefore construed as encompassing generic computing elements such as software.
The recitation of the reporting application amounts to mere instructions to implement functions within the abstract idea using computing elements as tools. Specifically, the reporting application is recited at a high level of generality as implemented to perform the data processing function of determining the question, and is disclosed broadly in the specification. The reporting application is therefore not sufficient to integrate the abstract idea into a practical application or to amount to significantly more than the abstract idea.
Claim 18 recites the mapping of the system events is user-defined and includes the first worksheet question that is answered by the first worksheet answer. These limitations fall within the scope of the abstract idea as set out above.
Claim 19 recites entering the clinical result and populating the medical worksheet with the clinical result. These limitations fall within the scope of the abstract idea as set out above.
Claim 19 further recites the additional elements of a) the reporting application implemented to enter the clinical result and populate the medical worksheet, and b) an API which receives the clinical result and from which the medical worksheet is populated.
Paragraphs 81 and 97 describe functions including populating the worksheet as performed by a processing system implementing a reporting application, which is described as processing logic comprising software run on a general-purpose computing system. The reporting application is therefore construed as encompassing generic computing elements such as software.
Similarly, paragraphs 82 and 97 reflects the language of the claim in stating that “In some embodiments, the reporting application is implemented to enter the clinical result into an application protocol interface (API), and populate, from the API, the medical worksheet with the clinical result.” No further description of the API itself is provided.
The above elements amount to mere instructions to implement functions within the abstract idea using computing elements as tools. Specifically, the reporting application is recited at a high level of generality as implemented to perform the data processing functions of entering the clinical result populating the medical worksheet, and is disclosed broadly in the specification. The API is likewise only recited at a high level of generality as receiving the clinical result and being used to populate the medical worksheet, and is disclosed broadly in the specification. The reporting application and API are therefore not sufficient to integrate the abstract idea into a practical application or to amount to significantly more than the abstract idea.
Claim 20 recites receiving a dictionary update; and amending, based on the dictionary update, the dictionary, said amending including an action selected from the group consisting of adding at least one question from the dictionary and to removing at least one additional question from the dictionary. These limitations fall within the scope of the abstract idea as set out above.
Claim 20 further recites the additional element of the reporting application as implemented to receive the dictionary update and amend the dictionary.
Paragraphs 81 and 83 similarly describe functions as performed by a processing system implementing a reporting application, which is described as processing logic comprising software run on a general-purpose computing system. The reporting application is therefore construed as encompassing generic computing elements such as software.
The recitation of the reporting application amounts to mere instructions to implement functions within the abstract idea using computing elements as tools. Specifically, the reporting application is recited at a high level of generality as implemented to perform the data processing functions of receiving the dictionary update and amending the dictionary, and is disclosed broadly in the specification. The reporting application is therefore not sufficient to integrate the abstract idea into a practical application or to amount to significantly more than the abstract idea.
Claim 21 recites storing a mapping of threshold conditions to questions on the medical worksheet. These limitations fall within the scope of the abstract idea as set out above.
Claim 21 further recites the additional element of the memory as being used to store the mapping.
Paragraphs 80, 100, and 103 describe a memory such as DRAM, ROM, or flash memory, as well as the memory “maintaining” a user-defined mapping of threshold conditions. The memory is therefore construed as encompassing generic computer storage elements.
The recitation of the memory amounts to mere instructions to implement functions within the abstract idea using computing elements as tools. Specifically, the memory is recited at a high level of generality as implemented to store data in the form of the threshold-condition mappings and is disclosed broadly in the specification. The memory is therefore not sufficient to integrate the abstract idea into a practical application or to amount to significantly more than the abstract idea.
Claims 1 and 3-21 are therefore rejected under 35 U.S.C. 101 as being directed to non-statutory subject matter.
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.
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.
Claims 1, 4-6, 9, 17, and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Hare II et al (US Patent Application Publication 2021/0259664) (hereinafter Hare) in view of McLeod (US Patent Application Publication 2022/0280133).
With respect to claim 1, Hare discloses the claimed ultrasound reporting system comprising:
a memory configured to store a mapping of system events including a first system event of saving a first ultrasound image in the memory and worksheet answers including a first worksheet answer indicating that a first view of a patient's anatomy has been obtained for a medical worksheet to report an ultrasound examination of the patient's anatomy according to a medical protocol, the medical worksheet comprising a first worksheet question about whether or not the first view of the patient's anatomy has been obtained that is associated with the first worksheet answer (Figures 22A-E, [198], [207], [209], [211], [213], [216], and [218] describe the system having view types to be captured as part of defined workflow protocols and thresholds, which when exceeded, indicate that the corresponding view has been captured, i.e. system events mapped to worksheet answers; Figures 22A and 22E, [43], [211], [213], and [216] additionally describe capturing an ultrasound image upon determining that the view is acceptable and populating a checkmark indicating this in the workflow list. Figures 22B-22E show a worksheet having a list of views to be collected and answers in the form of checkmarks next to a view when it is captured. With respect to the interpreted scope of a “worksheet question” and “worksheet answer,” Examiner notes Figure 2B and paragraphs 58 and 68 of Applicant’s disclosure, where populating an affirmative response, such as a checkmark, next to a listed view is described as a question and answer);
a display device coupled to the memory (Figure 20A element 1824, Figure 20B, [181], and [206] describe a mobile device with a display); and
a processor system coupled to the memory and the display device and configured to implement a reporting application at least partially in hardware (Figures 1A, 1C, and 2, [40]-[42], [180], [181], and [206] describe the various portions of the computing environment; [38]-[40], [44], [45], and Claim 25 describe use of software and executable instructions stored in non-transitory memory), the reporting application implemented to:
determine, during the ultrasound examination, the saving the first ultrasound image in the memory (Figure 22A, [204] [206], [216], and [217] describe determining whether a confidence level has exceeded a threshold for a specific type of view during an ultrasound examination; Figures 22A and 22E, [43], [211], [213], and [216] describe capturing an ultrasound image upon determining that the view is acceptable and populating a checkmark indicating this in the workflow list);
determine, using the mapping, the first worksheet answer indicating that the first view of the patient’s anatomy has been obtained responsive to the saving the first ultrasound image in the memory (Figures 22A-E, [195], [198], [206], [209], [211], [213], and [216] describe a workflow including a required set of views to capture, i.e. a medical worksheet, determining a particular view being captured and stored, and populating a checkmark indicating this in the workflow list upon capture); and
populate, during the ultrasound examination the medical worksheet with the first worksheet answer indicating that the first view of the patient’s anatomy has been obtained, wherein the medial worksheet is not populated when the saving of the first ultrasound image in the memory is not determined (Figures 22A-E, [197], [211], [213]-[216] describe populating a workflow list with a checkmark indicating that a corresponding image has been captured based on the confidence exceeding a threshold; Figures 22B and 22C show views on the worksheet not having a checkmark, i.e. the worksheet has not been populated due to those views not being saved); and
display the medical worksheet on the display device (Figures 22B-22E show views of the worksheet displayed on the device);
but does not expressly disclose:
receive, via the display device, a user selection of an auto-populating feature to enable auto-population of the medical worksheet with worksheet data based on the mapping and determine measurements responsive to receipt;
However, McLeod teaches that it was old and well known in the art of ultrasound examination before the effective filing date of the claimed invention to receive, via a display device, a user selection of an auto-populate feature to enable auto-population of a worksheet with worksheet data (Figures 2 and 3 element 328, [36], [38], [48], [52], and [53] describe an ultrasound system receiving a user selection on a screen of whether to automatically acquire one or more measurements which are then presented on the screen).
Therefore it would have been obvious to one of ordinary skill in the art of ultrasound examination before the effective filing date of the claimed invention to modify the system of Hare to receive, via a display device, a user selection of an auto-populate feature to enable auto-population of a worksheet with worksheet data as taught by McLeod since the claimed invention is only a combination of these old and well known elements which would have performed the same function in combination as each did separately. In the present case Hare already discloses an auto-populate feature, and receiving a user selection to enable the auto-populate feature and populating the worksheet based thereon as taught by McLeod would serve that same function in Hare, making the results predictable to one of ordinary skill in the art (MPEP 2143).
With respect to claim 4, Hare discloses the ultrasound reporting system as described in claim 1. Hare further discloses:
a neural network implemented at least partially in the hardware to determine, during the ultrasound examination, that the ultrasound examination implements a step of a protocol (Figures 19 and 22A element 2204, [186], and [206] describe a neural network analyzing the ultrasound image data to classify the view currently being captured, i.e. a step of a protocol); and
the display device is implemented to display, automatically and without user intervention, a portion of the medical worksheet that corresponds to the step of the protocol (Figure 19 element 1904, Figure 20B element 2002, Figure 22A elements 2206-2208, and Figures 22B-22E, [188], and [211]-[214] describe the display automatically presenting the view currently being acquired).
With respect to claim 5, Hare discloses the ultrasound reporting system as described in claim 4. Hare further discloses:
wherein the display device is implemented to display the portion of the medical worksheet that corresponds to the step of the medical protocol including not to display other portions of the medical worksheet that do not correspond to the step of the protocol (Figure 20B element 2002 shows a display of the current view being captured without displaying the other views to be captured in the protocol).
With respect to claim 6, Hare discloses the ultrasound reporting system as described in claim 1. Hare further discloses:
wherein the memory is implemented to maintain the medical protocol ([197] and [218] describe a protocol as having a predetermined workflow of view types to capture, i.e. an order of steps for capturing the view types), the reporting application is implemented to determine, based on the first system event corresponding to a current protocol step of the protocol, a next protocol step of the protocol (Figure 21 elements 2114-2118, Figure 22A, [197], and [218] describe the protocol as having a predetermined workflow of view types, and transmitting a prompt to the user to capture the “next view type” after capturing the current view type), and the display device is implemented to display a portion of the medical worksheet that corresponds to the next protocol step (Figure 19 element 1904, Figure 20B element 2002, Figure 22A elements 2206-2208, and Figures 22B-22E, [188], and [211]-[214] describe the display automatically presenting the view currently being acquired).
With respect to claim 9, Hare discloses the ultrasound reporting system as described in claim 1. Hare further discloses:
wherein the reporting application is implemented to receive a user selection of a worksheet display feature and display the medical worksheet based on the user selection ([195], [197], [206], and [209]-[211] describe a user selecting an option to record and the system displaying the worksheet of Figures 22B-22E based on the selection).
With respect to claim 17, Hare discloses the claimed ultrasound reporting system comprising:
a processing system (Figures 1A, 1C, and 2, [40]-[42], [180], [181], and [206] describe the various portions of the computing environment);
a memory coupled to the processing system ([38]-[40], [44], and [45] describe system memory storing instructions and data for performing the functions) to store a mapping of system events including a first system event of saving a first ultrasound image in the memory and worksheet answers including a first worksheet answer indicating that a first view of a patient's anatomy has been obtained for a medical worksheet to report an ultrasound examination of the patient's anatomy according to a medical protocol (Figures 22A-E, [198], [207], [209], [211], [213], [216], and [218] describe the system having view types to be captured as part of defined workflow protocols and thresholds, which when exceeded, indicate that the corresponding view has been captured, i.e. system events mapped to worksheet answers; Figures 22A and 22E, [43], [211], [213], and [216] additionally describe capturing an ultrasound image upon determining that the view is acceptable and populating a checkmark indicating this in the workflow list. Examiner notes that the claim does not limit what constitutes a “worksheet,” a “worksheet answer,” or how an answer indicates that the ultrasound image includes an acceptable view. A checkmark next to a view to be captured is construed as falling with the scope of an answer “indicating” that the captured view is acceptable);
a display device coupled to the memory (Figure 20A element 1824, Figure 20B, [181], and [206] describe a mobile device with a display); and
at least one computer-readable storage medium configured to store instructions executable via the processing system to implement a reporting application ([38]-[40], [44], and [45] describe use of software and executable instructions stored in memory) configured to:
access a dictionary of worksheet questions comprising a first worksheet question about whether or not the first view of the patient's anatomy has been obtained associated with the worksheet answers comprising the first worksheet answer for the ultrasound examination stored in the memory ([42] and [43] describe the ultrasound system for performing an ultrasound examination; Figures 15 and 20C, [161], and [191] show reports having a set of main findings, where each main finding is construed as a question to be answered during the ultrasound examination, and the system would need to store possible findings in some manner; Figures 22A-E, [198], [207], [209], [211], [213], and [216] also describe the system having view types to be captured as part of workflow protocols and indications of the views for presentation on the GUI, where the list of views to be indicated as obtained may also be construed as part of a dictionary of questions. With respect to the interpreted scope of a “worksheet question” and “worksheet answer,” Examiner notes Figure 2B and paragraphs 58 and 68 of Applicant’s disclosure, where populating an affirmative response, such as a checkmark, next to a listed view is described as a question and answer);
determine, during the ultrasound examination, the saving the first ultrasound image in the memory (Figure 22A, [204] [206], [216], and [217] describe determining whether a confidence level has exceeded a threshold for a specific type of view during an ultrasound examination; Figures 22A and 22E, [43], [211], [213], and [216] describe capturing an ultrasound image upon determining that the view is acceptable and populating a checkmark indicating this in the workflow list); and
generate, using the mapping, a clinical result that includes the first worksheet answer indicating that the first view of the patient’s anatomy has been obtained in response to the saving the first ultrasound image in the memory (Figures 22A-E, [197], [211], [213]-[216] describe populating a workflow list with a checkmark indicating that a corresponding image has been captured based on the confidence exceeding a threshold);
populate, during the ultrasound examination, the medical worksheet with the first worksheet answer indicating that the first view of the patient's anatomy has been obtained, wherein the medical worksheet is not populated when the saving of the first ultrasound image in the memory is not determined (Figures 22A-E, [197], [211], [213]-[216] describe populating a workflow list with a checkmark indicating that a corresponding image has been captured based on the confidence exceeding a threshold; Figures 22B and 22C show views on the worksheet not having a checkmark, i.e. the worksheet has not been populated due to those views not being saved); and
display the medical worksheet on the display device (Figures 22B-22E show views of the worksheet displayed on the device);
but does not expressly disclose:
receive, via the display device, a user selection of an auto-populate feature to enable auto-population of the medical worksheet with worksheet data based on the mapping of the system events and the worksheet answers.
However, McLeod teaches that it was old and well known in the art of ultrasound examination before the effective filing date of the claimed invention to receive, via a display device, a user selection of an auto-populate feature to enable auto-population of a worksheet with worksheet data (Figures 2 and 3 element 328, [36], [38], [48], [52], and [53] describe an ultrasound system receiving a user selection on a screen of whether to automatically acquire one or more measurements which are then presented on the screen).
Therefore it would have been obvious to one of ordinary skill in the art of ultrasound examination before the effective filing date of the claimed invention to modify the system of Hare to receive, via a display device, a user selection of an auto-populate feature to enable auto-population of a worksheet with worksheet data as taught by McLeod since the claimed invention is only a combination of these old and well known elements which would have performed the same function in combination as each did separately. In the present case Hare already discloses an auto-populate feature, and receiving a user selection to enable the auto-populate feature and populating the worksheet based thereon as taught by McLeod would serve that same function in Hare, making the results predictable to one of ordinary skill in the art (MPEP 2143).
With respect to claim 21, Hare discloses the ultrasound reporting system as described in claim 1. Hare further discloses:
wherein the memory is configured to store a mapping of threshold conditions to questions on the medical worksheet (Figures 22A-E, [198], [207], [209], [211], [213], and [216] describe the system having view types to be captured as part of workflow protocols and thresholds, which when exceeded, indicate that the corresponding view has been captured, i.e. system events mapped to worksheet answers).
Claims 3, 7, 10, and 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Hare II et al (US Patent Application Publication 2021/0259664)(hereinafter Hare) as applied to claims 1, 6, and 17 above, and further in view of Torres et al (US Patent Application Publication 2020/0111553).
With respect to claim 3, Hare discloses the ultrasound reporting system as described in claim 1. Hare further discloses:
wherein the mapping of the system events includes the first worksheet question that is answered by the first worksheet answer (Figures 22A-E, [198], [207], [209], [211], [213], and [216] describe the system having view types to be captured as part of workflow protocols and thresholds, which when exceeded, indicate that the corresponding view has been captured, i.e. system events mapped to worksheet answers);
but does not expressly disclose:
the mapping being user-defined.
However, Torres teaches that it was old and well known in the art of ultrasound examination before the effective filing date of the claimed invention to provide a user-defined worksheet question mapping ([33], [76], [96], and [101] describe a user being able to customize a worksheet mapping comprising question fields).
Therefore it would have been obvious to one of ordinary skill in the art of ultrasound examination before the effective filing date of the claimed invention to modify the system of Hare to provide a user-defined worksheet question mapping as taught by Torres since the claimed invention is only a combination of these old and well known elements which would have performed the same function in combination as each did separately. In the present case Hare already discloses a mapping of worksheet questions and worksheet answers, and having the mapping be defined by a user as taught by Torres would serve that same function in Hare, making the results predictable to one of ordinary skill in the art (MPEP 2143).
With respect to claim 7, Hare discloses the ultrasound reporting system as described in claim 6. Hare further discloses:
wherein the memory is implemented to maintain orders of steps of the protocol ([197] and [218] describe the protocol as having a predetermined workflow of view types to capture, i.e. an order of steps for capturing the view types) and the determination of the next protocol step is based on the current protocol step and the orders of steps of the protocol maintained by the memory ([197] describes the protocol as having a predetermined workflow of view types, and transmitting a prompt to the user to capture the “next view type” after capturing the current view type);
but does not expressly disclose:
the order of steps being based on operator identifications,
the reporting application is implemented to determine an operator identification for an operator performing the ultrasound examination, and
the determination of the next protocol step is based on the operator identification.
However, Torres teaches that it was old and well known in the art of ultrasound examination before the effective filing date of the claimed invention to maintain an order of protocol steps based on operator identification ([13], [33], [76], [96], and [101] describe a user being able to define a worksheet specifying the organization and order of the fields to enable particular data-gathering workflows, i.e. an order of steps), determine an operator identification for an operator performing the ultrasound examination ([13], [94], [96], and [109] describe receiving the identification of an operator or user of the ultrasound device), and determine a next protocol step based on the operator identification ([13], [33], [76], [96], and [101] describe the worksheet the organization and order of data capture fields to enable particular data-gathering workflows while [40], [82], and [105] describe the user filling in the data fields during examination).
Therefore it would have been obvious to one of ordinary skill in the art of ultrasound examination before the effective filing date of the claimed invention to modify the system of Hare to maintain an order of protocol steps based on operator identification, determine an operator identification for an operator performing the ultrasound examination, and determine a next protocol step based on the operator identification as taught by Torres since the claimed invention is only a combination of these old and well known elements which would have performed the same function in combination as each did separately. In the present case Hare already discloses an order of steps in a protocol and determining a next protocol step, and basing the order of protocol steps on operator identification, determining the identity of the operator, and determining the next protocol step based on the operator identification as taught by Torres would serve that same function in Hare, making the results predictable to one of ordinary skill in the art (MPEP 2143).
With respect to claim 10, Hare discloses the ultrasound reporting system as described in claim 1. Hare further discloses:
wherein the memory is implemented to maintain the medical protocol for the ultrasound examination ([197] and [218] describe a protocol as having a predetermined workflow of view types to capture, i.e. an order of steps for capturing the view types),
but does not expressly disclose:
the reporting application is implemented to obtain the medical protocol from an ultrasound machine.
However, Torres teaches that it was old and well known in the art of ultrasound examination before the effective filing date of the claimed invention to obtain a medical protocol from an ultrasound machine (Figure 1 element 10, [39], [51], [75], and [76] describe the system software, i.e. a reporting application, of an ultrasound point-of-care system obtaining a protocol from its own local storage, i.e. from an ultrasound machine).
Therefore it would have been obvious to one of ordinary skill in the art of ultrasound examination before the effective filing date of the claimed invention to modify the system of Hare to obtain a medical protocol from an ultrasound machine as taught by Torres since the claimed invention is only a combination of these old and well known elements which would have performed the same function in combination as each did separately. In the present case Hare already discloses a memory maintaining a medical protocol, and obtaining it from an ultrasound machine as taught by Torres would serve that same function in Hare, making the results predictable to one of ordinary skill in the art (MPEP 2143).
Claim 18 recites limitations similar to those in claim 3, and is rejected on the same grounds set out above with respect to claim 3.
With respect to claim 19, Hare discloses the ultrasound reporting system as described in claim 18. Hare does not expressly disclose wherein the reporting application is implemented to enter the clinical result into an application protocol interface (API), and populate, from the API, the medical worksheet with the clinical result.
However, Torres teaches that it was old and well known in the art of ultrasound examination before the effective filing date of the claimed invention to enter a clinical result into an API, and populate, from the API, a medical worksheet with the clinical result ([12], [70], [97], and [98] describe a clinician entering results from an examination into a worksheet by passing them through an API).
Therefore it would have been obvious to one of ordinary skill in the art of ultrasound examination before the effective filing date of the claimed invention to modify the system of Hare to enter a clinical result into an API, and populate, from the API, a medical worksheet with the clinical result as taught by Torres since the claimed invention is only a combination of these old and well known elements which would have performed the same function in combination as each did separately. In the present case Hare already discloses entering a clinical result and populating a medical worksheet with the clinical result, and doing so by entering it into an API and populating the worksheet from the API as taught by Torres would serve that same function in Hare, making the results predictable to one of ordinary skill in the art (MPEP 2143).
With respect to claim 20, Hare discloses the ultrasound reporting system as described in claim 17. Hare does not expressly disclose wherein the reporting application is implemented to: receive a dictionary update; and amend, based on the dictionary update, the dictionary, said amend including an action selected from the group consisting of to add at least one question from the dictionary and to remove at least one additional question from the dictionary.
However, Torres teaches that it was old and well known in the art of ultrasound examination before the effective filing date of the claimed invention to receive a dictionary update; and amend, based on the dictionary update, the dictionary, said amend including an action selected from the group consisting of to add at least one question from the dictionary and to remove at least one additional question from the dictionary ([33], [76], [96], and [101] describe a user being able to customize the question fields on a worksheet, where the questions assigned to the worksheet are construed as a “dictionary” and the user submitting an edit to the questions assigned to the worksheet is construed as a dictionary update).
Therefore it would have been obvious to one of ordinary skill in the art of ultrasound examination before the effective filing date of the claimed invention to modify the system of Hare to receive a dictionary update; and amend, based on the dictionary update, the dictionary, said amend including an action selected from the group consisting of to add at least one question from the dictionary and to remove at least one additional question from the dictionary as taught by Torres since the claimed invention is only a combination of these old and well known elements which would have performed the same function in combination as each did separately. In the present case Hare already discloses a dictionary of questions for an ultrasound examination, and amending the dictionary based on a dictionary update to add at least one question from the dictionary or remove at least one additional question from the dictionary as taught by Torres would serve that same function in Hare, making the results predictable to one of ordinary skill in the art (MPEP 2143).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Hare II et al (US Patent Application Publication 2021/0259664)(hereinafter Hare) as applied to claim 1 above, and further in view of Torres et al (US Patent Application Publication 2020/0111553) and Rao et al (US Patent Application Publication 2019/0148011).
With respect to claim 8, Hare discloses the ultrasound reporting system as described in claim 1. Hare further discloses:
an ultrasound machine implemented to perform the ultrasound examination (Figure 1A element 24, Figure 20A, and Figure 21 element 1824, [42], and [43] describe an ultrasound imaging device capturing images of the patient), wherein the memory is implemented to maintain orders of steps of the medical protocol ([197] describes the protocol as having a predetermined workflow of view types to capture, i.e. an order of steps for capturing the view types), wherein the reporting application is implemented to:
determine, based on the orders of steps of the medical protocol, a step in the medical protocol ([197] describes the protocol as having a predetermined workflow of view types, and transmitting a prompt to the user to capture the “next view type” after capturing the current view type);
but does not expressly disclose:
the order of steps being based on operator identifications,
determining an operator identification for an operator of the ultrasound machine;
the determination of the medical protocol step is based on the operator identification, and
configuring the ultrasound machine for the step in the medical protocol.
However, Torres teaches that it was old and well known in the art of ultrasound examination before the effective filing date of the claimed invention to maintain an order of medical protocol steps based on operator identification ([13], [33], [76], [96], and [101] describe a user being able to define a worksheet specifying the organization and order of the fields to enable particular data-gathering workflows, i.e. an order of steps), determine an operator identification for an operator performing the ultrasound examination ([13], [94], [96], and [109] describe receiving the identification of an operator or user of the ultrasound device), and determine a next protocol step based on the operator identification ([13], [33], [76], [96], and [101] describe the worksheet the organization and order of data capture fields to enable particular data-gathering workflows while [40], [82], and [105] describe the user filling in the data fields during examination).
Therefore it would have been obvious to one of ordinary skill in the art of ultrasound examination before the effective filing date of the claimed invention to modify the system of Hare to maintain an order of medical protocol steps based on operator identification, determine an operator identification for an operator performing the ultrasound examination, and determine a next protocol step based on the operator identification as taught by Torres since the claimed invention is only a combination of these old and well known elements which would have performed the same function in combination as each did separately. In the present case Hare already discloses an order of steps in a protocol and determining a next protocol step, and basing the order of protocol steps on operator identification, determining the identity of the operator, and determining the next protocol step based on the operator identification as taught by Torres would serve that same function in Hare, making the results predictable to one of ordinary skill in the art (MPEP 2143).
Rao further teaches that it was old and well known in the art of ultrasound examination before the effective filing date of the claimed invention to configure an ultrasound machine for a step in a protocol ([6], [29], [64], [66], [73], and [96] describe the system altering the configuration of an ultrasound machine during a protocol in order to perform a next act in the protocol).
Therefore it would have been obvious to one of ordinary skill in the art of ultrasound examination before the effective filing date of the claimed invention to modify the system of Hare to configure an ultrasound machine for a step in a protocol as taught by Rao since the claimed invention is only a combination of these old and well known elements which would have performed the same function in combination as each did separately. In the present case Hare already discloses an ultrasound machine and steps in a protocol, and basing the order of protocol steps on operator identification, determining the identity of the operator, and configuring the ultrasound machine for the step in the protocol as taught by Rao would serve that same function in Hare, making the results predictable to one of ordinary skill in the art (MPEP 2143).
Claims not Rejected under 35 USC 102/103
Claims 11-14 and 16 are not presently recited under 35 USC 102/103 in view of the closest prior art of record cited herein.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Reicher (US Patent Application Publication 2018/0060488);
Van der Veen et al (US Patent Application Publication 2021/0202069);
Naidu et al (US Patent Application Publication 2022/0401062);
Jafari et al, Automatic biplane left ventricular ejection fraction estimation with mobile point-of-care ultrasound using multi-task learning and adversarial training.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WILLIAM G LULTSCHIK whose telephone number is (571)272-3780. The examiner can normally be reached 9am - 5pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Fonya Long can be reached at (571) 270-5096. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/Gregory Lultschik/Examiner, Art Unit 3682
Prosecution Insights