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 .
Notice to Applicant
This communication is in response to the amendment filed 12/5/2025. Claims 1, 11, and 17 have been amended. Claim 2 has been canceled. Claim 21 has been added. Claims 1 and 3-21 remain pending and have been examined.
Drawings
Replacement drawings were received on 12/05/2025. These drawings are acceptable.
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 10 of the response that the claims recite “an inventive concept that improves the technical field of ultrasound examination,” asserting that “when the system event occurs (e.g., the image is saved), the user does not need to manually enter an affirmative answer to the question "Was the Subcostal View Obtained?"” and that “[r]ather, when the image is saved, the system automatically populates the worksheet with the affirmative answer to the question that is mapped to this system event.” Examiner respectfully disagrees.
Examiner first notes that the steps of populating the worksheet with an answer mapped to a system event, including an answer to a question indicating that a view was obtained, falls within the scope of the abstract idea identified in Step 2A Prong 1. As explained in Prong 1, populating a worksheet with answers corresponding to the occurrence of events, such as saving of an image and a question about whether the view was obtained, could be performed by a user while performing the examination. This is supported by Applicant’s argument that “the user does not need to manually enter an affirmative answer to the question” and that the system instead “automatically” populates the answer. The use of computing elements such as a processor system and memory to perform the automation functions such as storing the answers which should be populated upon particular events and then automating the populating process is not itself sufficient to an improvement in technology or a technical field. Examiner notes MPEP 2106.05(a)(I) which lists “Mere automation of manual processes” among examples not sufficient to show an improvement in computer functionality.
Applicant provides substantially the same arguments with respect to claim 11, asserting that “[t]he disclosed techniques for automated reporting in POCUS workflows advantageously provide automated and/or assisted reporting that simplifies required tasks and immediate data entry within the clinical context.” Similarly to as set out above, steps such as determining that a threshold condition has been met, determining a corresponding question using a mapping, and populating an answer to the question using the mapping fall within the scope of the abstract idea as steps which could be performed by the individual performing the examination. The use of computing elements such as a processor system and memory to perform the automation functions is not itself sufficient to an improvement in technology or a technical field, and Examiner again notes MPEP 2106.05(a)(I) which lists “Mere automation of manual processes” among examples not sufficient to show an improvement in computer functionality.
Applicant asserts on pages 13 and 14 that claims 1 and 11 “impos[e] meaningful limits on the use of the Examiner-alleged "mere instructions to implement functions within the abstract idea",” highlighting the functions of a memory storing the mapping of system events/threshold conditions to worksheet answers as well as determining the occurrence of the event or satisfaction of the threshold condition and populating the worksheet. Examiner respectfully disagrees.
Examiner initially notes that the analysis under Step 2A Prong 1 and Step 2B involves whether additional elements within the claims provide meaningful limitations on the abstract idea, rather than meaningful limitations on additional elements which amount to, for example, mere instructions to implement the abstract idea.
With respect to the functions highlighted by Applicant, the functions involving storing the mapping of system events/threshold conditions to worksheet answers, determining the occurrence of a system even or satisfaction of a threshold condition, determining the mapped worksheet answer, and populating the answer in the medical worksheet fall within the scope of the abstract idea itself, and are not additional elements. The use of a memory or non-transitory computer readable medium to store the mapping and ultrasound image and a processing system to perform the automation tasks only amounts to mere instructions to implement these functions using generic computing elements as tools. As set out in Step 2A Prong 2, the memory and non-transitory computer readable medium are each only recited at a high level of generality as used to implement the data storage functions, and the processing system is likewise recited at a high level of generality and disclosed broadly as implementing the corresponding functions and encompassing generic computing elements.
The rejection under 35 USC 101 is maintained.
B. Applicant's arguments with respect to the rejection of claims 1, 3-15, and 17-21 under 35 USC 103 have been fully considered but they are not persuasive.
Applicant argues starting on page 15, that Hare fails to disclose the limitations recited in claim 1, stating that in contrast to Hale, “amended claim 1 refers to a memory configured to store a mapping of system events including a system event of saving an ultrasound image in the memory and worksheet answers including a worksheet answer indicating that the ultrasound image includes an acceptable view.” Examiner respectfully disagrees.
As set out below, Figures 22A-E and paragraphs 198, 207, 209, 211, 213, and 216 of Hale describe the system having a plurality of view types to be captured as part of workflow protocols and thresholds, which when exceeded, indicate that the corresponding view has been captured, which amounts to a mapping of events to answers. Figures 22A and 22E along with 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. As provided, 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.
Applicant presents substantially identical arguments with respect to claim 11, asserting that Hale does not teach the limitations of claim 11. While Applicant states that “Hare refers to at least one non-transitory computer-readable storage medium coupled to the processing system and configured to store a mapping including a satisfaction of a threshold condition for an ultrasound examination and a worksheet answer, wherein the worksheet answer is identified as being associated with a worksheet question corresponding to the threshold condition,” Examiner believes Applicant intended to assert that Hale does not disclose these limitations.
As set out below, Figures 22A-E and paragraphs 198, 207, 209, 211, 213, and 216 of Hale describe the system having a plurality of view types to be captured as part of workflow protocols and thresholds, which when exceeded, indicate that the corresponding view has been captured, which amounts to a mapping of events to answers. Figures 22A-E and paragraphs 198, 207, 209, 211, and 213 describe a workflow including a required set of views to capture, i.e. a medical worksheet, and determining a particular view being captured, i.e. a question, based on the threshold for the particular view.
Applicant does not provide further arguments specifically addressing why the cited references do not teach particular limitations for which they are relied upon.
The rejection under 35 USC 103 is maintained.
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 system event of saving an ultrasound image and worksheet answers including a worksheet answer indicating that the ultrasound image includes an acceptable view; and
determining, during an ultrasound examination, an occurrence of the system event of saving the ultrasound image;
determining, using the mapping, the worksheet answer of the worksheet answers that is mapped to the system event of saving the ultrasound image; and
populating, during the ultrasound examination and responsive to the determination of the occurrence of the system event, a medical worksheet with the worksheet answer indicating that the ultrasound image includes the acceptable view.
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 determining that a system event has occurred during an ultrasound examination, and using a mapping of threshold conditions to worksheet answers to enter an answer for a corresponding question into a medical worksheet. 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.
Independent claim 11 recites, in part, performing the steps of:
storing a mapping including a satisfaction of a threshold condition for an ultrasound examination and a worksheet answer, wherein the worksheet answer is identified as being associated with a worksheet question corresponding to the threshold condition;
determining, during the ultrasound examination, the satisfaction of the threshold condition;
determining from the mapping, the worksheet question on a medical worksheet corresponding to the threshold condition; and
populating, during the ultrasound examination and responsive to the determination of the satisfaction of the threshold condition, an answer field on the medical worksheet with the worksheet answer to the worksheet question on the medical worksheet corresponding to the satisfaction of the threshold condition using the mapping.
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 determining that a threshold condition has been met during an ultrasound examination, and using a mapping of threshold conditions to worksheet answers to enter an answer for a corresponding question into a medical worksheet. 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.
Independent claim 17 recites, in part, performing the steps of:
storing a mapping of system events including a system event of saving an ultrasound image and worksheet answers including a worksheet answer indicating that the ultrasound image includes an acceptable view;
accessing a dictionary of questions for an ultrasound examination;
determining, during the ultrasound examination, an occurrence of a system event of saving the ultrasound image; and
generating, using the mapping, a clinical result that includes an answer to a question in the dictionary in response to the system event of saving the ultrasound image, wherein the answer indicates that the ultrasound image includes an acceptable view.
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 determining that a system event has occurred during an ultrasound examination, and using a mapping of threshold conditions to worksheet answers to enter an answer for a corresponding question into a medical worksheet. 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.
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, and b) a processor system recited as coupled to the memory 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, and b) 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, and 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, and b) 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.
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 processing system and processor system are likewise recited at a high level of generality as 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 event is user-defined and includes a worksheet question answered by the 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 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) a 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 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 occurrence of the 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) a 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 a 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 protocol, a step in the 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 to enable an auto-populate feature, and said populate is 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 a protocol for the ultrasound examination, and obtaining the 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 threshold condition includes a threshold amount of free fluid, and the answer field includes an affirmation of free fluid detection. These limitations fall within the scope of the abstract idea as set out above.
Claim 13 recites wherein the threshold condition includes an image quality, and the answer field 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 maintaining 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 14 further recites the additional element of the non-transitory computer readable storage medium as implemented to maintain the user-defined 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 non-transitory computer readable storage medium amounts to mere instructions to implement functions within the abstract idea using computing elements as tools. Specifically, the non-transitory computer readable storage medium is recited at a high level of generality as implemented to store data in the form of the user-defined mappings and is disclosed broadly in the specification. The non-transitory computer readable storage medium is therefore not sufficient to integrate the abstract idea into a practical application or to amount to significantly more than the abstract idea.
Claim 15 recites wherein the ultrasound examination includes a protocol, the determination of the satisfaction of the threshold condition is during a current step of the protocol, and determining the 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 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 ultrasound examination includes a protocol, the determination of the satisfaction of the threshold condition is during a current step of the protocol, and determining the 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 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 populating a medical worksheet with the clinical result. These limitations fall within the scope of the abstract idea as set out above.
Claim 18 further recites the additional element of the reporting application as implemented to populate the medical worksheet.
Paragraphs 81 and 97 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 populating the medical worksheet, 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 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 § 102
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, 4-6, 11, 15, 17, 18, and 21 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Hare II et al (US Patent Application Publication 2021/0259664) (hereinafter Hare).
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 system event of saving an ultrasound image in the memory and worksheet answers including a worksheet answer indicating that the ultrasound image includes an acceptable view (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; 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); and
a processor system coupled to the memory 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 an ultrasound examination, an occurrence of the system event of saving an 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 worksheet answer of the worksheet answers that is mapped to the system event of saving an ultrasound image in the memory (Figures 22A-E, [198], [207], [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, determining that the view is acceptable, and populating a checkmark indicating this in the workflow list upon capture); and
populate, during the ultrasound examination and responsive to the determination of the occurrence of the system event, a medical worksheet with the worksheet answer indicating that the ultrasound image includes an acceptable view (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).
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
a display device 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 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:
a display device (Figure 20A element 1824, [181], and [206] describe a mobile device with a display), wherein the memory is implemented to maintain a 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 occurrence of the 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 11, 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); and
at least one non-transitory computer-readable storage medium coupled to the processing system and configured to store a mapping including a satisfaction of a threshold condition for an ultrasound examination and a 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), wherein the worksheet answer is identified as being associated with a worksheet question corresponding to the threshold condition (Figures 22A-E, [198], [207], [209], [211], and [213] describe a workflow including a required set of views to capture, i.e. a medical worksheet, and determining a particular view being captured, i.e. a question, based on the threshold for the particular view), wherein the at least one non-transitory computer-readable storage medium is further configured to store instructions executable via the processing system to implement a reporting application ([38]-[40], [44], [45], and Claim 25 describe use of software and executable instructions stored in non-transitory memory) configured to:
determine, during the ultrasound examination, the satisfaction of the threshold condition (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);
determine from the mapping, the worksheet question on a medical worksheet corresponding to the threshold condition (Figures 22A-E, [198], [207], [209], [211], and [213] describe a workflow including a required set of views to capture, i.e. a medical worksheet, and determining a particular view being captured, i.e. a question. Examiner notes that the broadest reasonable interpretation of a “question” in the context of a checklist workflow requiring collection of data includes the label corresponding to each checklist item to be completed given that the label for the yes/no checkbox amounts to a question of whether the information has been obtained. For example, Examiner notes paragraph 50 of Applicant’s specification where a question includes whether a view was obtained along with a yes/no answer); and
populate, during the ultrasound examination and responsive to the determination of the satisfaction of the threshold condition, an answer field on the medical worksheet with the worksheet answer to the worksheet question on the medical worksheet corresponding to the satisfaction of the threshold condition using the mapping (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).
With respect to claim 15, Hare discloses the ultrasound reporting system as described in claim 11. Hare further discloses:
wherein the ultrasound examination includes a 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 determination of the satisfaction of the threshold condition is during a current step of the protocol, and the reporting application is implemented to determine the question as part of the current 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, i.e. the threshold for a view is reached during the current step of the protocol and the question for the current step is whether the view has been acquired).
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 system event of saving an ultrasound image in the memory and worksheet answers including a worksheet answer indicating that the ultrasound image includes an acceptable view (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; 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); 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 questions for an 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. Examiner notes paragraph 50 of Applicant’s specification listing a ‘Yes/No’ indication of whether a view was obtained as one of the questions);
determine, during the ultrasound examination, an occurrence of the system event of saving the 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 an answer to a question in the dictionary in response to the system event of saving the ultrasound image in the memory, wherein the answer indicates that the ultrasound image includes an acceptable view (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).
With respect to claim 18, Hare discloses the ultrasound reporting system as described in claim 17. Hare further discloses:
wherein the reporting application is implemented to populate a medical worksheet with the clinical result (Figure 20C, Figure 21 element 2126, [190], [191], [199], and [200] describe the system generating and outputting clinical results such as “Mildly Abnormal” as an answer to the LV Systolic Function question).
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).
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 3, 7, 10, 14, 19, and 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, 11, 17, and 18 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 event includes a worksheet question answered by the 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 a 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 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 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 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 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).
With respect to claim 14, Hare discloses the ultrasound reporting system as described in claim 11. Hare further discloses:
wherein the at least one computer-readable storage medium is implemented to maintain 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), and the determination of the question is based on the mapping (Figures 22A-E, [198], [207], [209], [211], and [213] describe a workflow including a required set of views to capture, i.e. a medical worksheet, and determining a particular view being captured, i.e. a question, based on the threshold for the particular view);
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 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 a 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 protocol, a step in the 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 next protocol step is based on the operator identification, and
configuring the ultrasound machine for the step in the 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 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).
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).
Claim 9 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 McLeod (US Patent Application Publication 2022/0280133).
With respect to claim 9, Hare discloses the ultrasound reporting system as described in claim 1. Hare does not expressly disclose wherein the reporting application is implemented to receive a user selection to enable an auto-populate feature, and said populate is based on the user selection.
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 a user selection to enable an auto-populate feature, and said populate is based on the user selection (Figures 2 and 3 element 328, [36], [38], [48], [52], and [53] describe an ultrasound system receiving a user selection 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 a user selection to enable an auto-populate feature, and said populate is based on the user selection 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 populate the worksheet 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).
Claim 12 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 11 above, and further in view of Christopher et al (US Patent Application Publication 2023/0320694).
With respect to claim 12, Hare discloses the ultrasound reporting system as described in claim 11. Hare does not expressly disclose wherein the threshold condition includes a threshold amount of free fluid, and the answer field includes an affirmation of free fluid detection.
However, Christopher teaches that it was old and well known in the art of ultrasound examination before the effective filing date of the claimed invention to populate an answer field with an affirmation of free fluid detection upon detecting a volume of free fluid ([9] and [61] describe identifying a volume of free fluid, i.e. more than zero free fluid, during an ultrasound exam and displaying a result showing the volume, i.e. affirming the detection of the free fluid).
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 include a threshold amount of free fluid as a threshold condition and populate an affirmation of free fluid detection as taught by Christopher 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 threshold conditions and answer fields, and having the threshold condition include a threshold amount of free fluid and the answer field includes an affirmation of free fluid detection as taught by Christopher would serve that same function in Hare, making the results predictable to one of ordinary skill in the art (MPEP 2143).
Claim 13 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 11 above, and further in view of Dalvin et al (US Patent Application Publication 2019/0239850).
With respect to claim 13, Hare discloses the ultrasound reporting system as described in claim 11. Hare does not expressly disclose wherein the threshold condition includes an image quality, and the answer field 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.
However, Dalvin teaches that it was old and well known in the art of ultrasound examination before the effective filing date of the claimed invention to include image quality as a threshold condition and an image quality score as an answer field (Figure 4C, [34], [68], and [70] describe an ultrasound system which assesses image quality and outputs an image quality score using a threshold).
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 include image quality as a threshold condition and an image quality score as an answer field as taught by Dalvin 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 threshold conditions and answer fields, and having the threshold condition include an image quality and the answer field includes an image quality score as taught by Dalvin 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
Claim 16 is 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.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/Gregory Lultschik/Examiner, Art Unit 3682