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 .
Response to Amendment
The Amendment filed 08/06/2026 has been entered. Claims 1-14 remain pending.
In response to Applicant’s amendment of Claim 5, the objection to the claim is withdrawn.
In response to Applicant’s amendment of the title of the invention, the objection to the specification is withdrawn.
Response to Arguments
Applicant’s arguments, filed 08/06/2026, with respect to the objection to the Drawings have been fully considered and are persuasive. The objection to the Drawings has been withdrawn.
Applicant's arguments, filed 08/06/2026, with respect to the interpretation of Claims have been fully considered but they are not persuasive. A “functional unit,” although described in the specification in cited paragraphs of Applicant’s arguments, is a generic placeholder because a person of ordinary skill in the art reading the specification would not have understood “functional unit” to have a sufficiently definite meaning as the name for the structure that performs the function. Paragraph [0009] of the specification recites “The functional unit may be configured to perform any function of the device, in particular any of its main functions. For example, when the device is a medical device, a function may be a medical function such as a measurement of a body function of a patient or the like. When the device is a camera, the function may be the recording of images, optionally with sound. When the device is a medical instrument, the function may comprise cutting, gripping, sealing, and/or the like.” Although Applicant cites particular examples given in paragraphs [0080], [0091], and [0095], the specification recites the functional unit may perform “any function of the device,” and thus does not provide a sufficiently definite meaning of “functional unit.”
However, Applicant correctly identifies “the corresponding structure as functional unit 120 described in paragraphs [0080], [0091], and [0095] of the specification as filed,” and thus “no indefiniteness issue under 35 U.S.C. 112(b) arises.”
Applicant’s arguments, filed 08/06/2026, with respect to the rejection of Claims 1, 2, 4, 6, 8, 9, 12, and 13 under 35 U.S.C. 101 have been fully considered and are persuasive. The rejections under 35 U.S.C. 101 have been withdrawn.
Applicant’s arguments, filed 08/06/2026, with respect to the rejection of Claims 5, 6, 9-11, and 14 under 35 U.S.C. 103 have been fully considered and are persuasive. The rejection of record under 35 U.S.C. 103 has been withdrawn.
Applicant’s arguments with respect to the rejections of Claims 1, 4, 7, 8, 12, and 13 under 35 U.S.C. 102 and 35 U.S.C. 103 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Nonetheless, relevant responses to arguments are below.
Regarding Claims 1 and 12, in response to Applicant’s argument that the interpretation that any recorded data is recorded 'periodically or continuously,’ “would render the ‘periodically or continuously’ limitation meaningless, contrary to the principle that claim terms should be given effect,” the rejection below cites a different portion of Iwamura. Nonetheless, an evidentiary reference is provided: Fisher, Dictionary of Computer Vision and Image processing, published 2005 defines video: “video: 1) Generic term for a set of images taken at successive instants with small time intervals between them.” Iwamura, [0021] also discloses “the medical information processing apparatus 30 saves therein moving images such as ultrasound image data or the like.” It would be obvious to one of ordinary skill in the art that a moving image is a video, and that small time intervals between images are periods. Thus, it would be obvious to one of ordinary skill in the art that a moving images is a set of images acquired periodically. Thus, under the broadest reasonable interpretation, moving image data such as ultrasound image data is data recorded “periodically.”
Applicant's arguments, filed 08/06/2026, with respect to Claims 2 and 3 have been fully considered but they are not persuasive.
Regarding Claim 2, in response to Applicant’s argument that Iwamura does not teach structured data, Iwamura at least teaches a DICOM tag including patient information and thus teaches “structured data comprising data fields indicating…at least one device or person being present…during the performing of the function.” Applicant also argues that DICOM tag fields are metadata about a medical image, not structure data pertaining to the function of the device; under the rejection below, the function of the device is medical image diagnosis, thus DICOM tag fields pertain to the function of diagnosis. Thus, the arguments with respect to Claim 2 are not considered persuasive.
Regarding Claim 3, in response to Applicant’s argument that the medical image diagnosis apparatus of Iwamura includes only “diagnostic imaging modalities that acquire images of patient anatomy, not images of a scene within a room of the medical facility,” the patient is part of a scene within a room of the medical facility, and thus images of patient anatomy is image data of a scene within a room of the medical facility. The claim does not require capturing information other than patient anatomy (specific people, non-anatomical events, etc. ) but merely requires image data “of a scene within a room of the medical facility,” that room including “a patient room.” Thus, the arguments with respect to Claim 3 are not considered persuasive.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-4, 7, 12, and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Iwamura et al. (US 2020/0193595 A1) in view of Mitsui et al. (US 2017/0112356 A1), further in view of Shinagawa et al. (US 2023/0033783 A1).
Regarding Claim 1, Iwamura teaches “A device for performing a function in a medical facility” (Iwamura, [0016] discloses “As illustrated in FIG. 1, the medical information processing system 1 according to the first embodiment includes a medical image diagnosis apparatus 10, a medical information processing apparatus 20, another medical information processing apparatus 30, yet another medical information processing apparatus 40, and a terminal device 50”; where medical information processing system is a device), “the device comprising:
“a functional unit configured to perform a function of the device” (Iwamura, [0017] discloses “The medical image diagnosis apparatus 10 is configured to acquire medical image data from the patient and to output the acquired medical image data to one of the medical information processing apparatus 20 and the medical information processing apparatus 30”; where medical image diagnosis apparatus 10 is a functional unit; where diagnosis is a function of the device);
“a data recorder configured to record, periodically or(Iwamura, [0021] discloses “The medical information processing apparatus 30 is an apparatus configured to save therein medical image data acquired by the medical image diagnosis apparatus 10”; where a medical information processing apparatus is a data recorder; where saving medical image data is recording data pertaining to the function (diagnosis) of the device. Iwamura, [0021] also discloses “the medical information processing apparatus 30 saves therein moving images such as ultrasound image data or the like”; where moving images such as ultrasound image data or the like is periodically recorded data. See “Response to Arguments,” above);
“a data processor configured to select, based on the query, a portion of the recorded data” (Iwamura, [0020] discloses “Further, the medical information processing apparatus 20 is configured to acquire, from the medical information processing apparatus 30, relevant image data relevant to the medical image data acquired from the medical image diagnosis apparatus 10” and “Further, the medical information processing apparatus 20 is configured to acquire medical image data resulting from image processing processes performed by the medical information processing apparatus 40, from the medical information processing apparatus 40. Further, the medical information processing apparatus 20 is configured to output image data corresponding to a request from the terminal device 50, to the terminal device 50”; where relevant image data is a portion of the recorded data; where a request from the terminal device is a query); “and
an output interface configured to output an output signal providing the selected portion of the recorded data in response to the query(Iwamura, [0023] discloses “The terminal device 50 is a device configured to present an image interpreting doctor with various types of image data. The terminal device 50 is configured to acquire the image data from the medical information processing apparatus 20 in response to an input operation received from the image interpreting doctor and to cause a display device to display the acquired image data”; where a terminal device is an output interface; where image data is an output signal providing the selected portion of the recorded data).
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Fig. 1 of Iwamura
Iwamura does not explicitly teach “an input interface configured to receive a query for data” and “wherein the device is configured such that recorded data other than the selected portion is not transmitted from the device in response to the query, thereby reducing bandwidth and storage space needed for providing data in response to the query.” That is, although Iwamura discloses medical information processing apparatus 20 includes responding to a request from the terminal device, where a request from the terminal device is query (Iwamura, [0028] discloses “Further, for example, the processing circuitry 240 is configured to output, to the terminal device 50, such a piece of image data from among the pieces of image data stored in the image storage circuitry 220 that corresponds to the request from the terminal device 50, by reading and executing a program corresponding to the output function 246 from the storage circuitry 210”), Iwamura does not explicitly teach a distinct “input interface.”
However, in an analogous field of endeavor, Mitsui teaches “an input interface configured to receive a query for data” (Mitsui, [0040] discloses “an input unit 150 adapted to input, to the control unit 140, a signal in accordance with to operation of the outside.” Mitsui, [0076] discloses “In the case where a request signal to perform the special light imaging is received from the input unit 150 during execution of the normal light imaging, the special light imaging is performed in a next frame”; where an input unit 150 is an input interface; where a request signal to perform special light imaging is a query for data).
It would have been obvious to one of ordinary skill in the art before the effective filing
date of the claimed invention to have modified Iwamura to incorporate the teachings of Mitsui by incorporating an input unit that may receive a request signal to perform a particular function. The prior art Iwamura contained a ‘base’ device upon which the claimed invention can be seen as an ‘improvement.’ Iwamura teaches a medical information processing apparatus including a diagnosis apparatus (functional unit), medical information processing apparatuses (data recorder and data processor), and a terminal device (output interface). The claimed invention recites “an input interface” and thus can be seen as an improvement over Iwamura. The prior art Mitsui contained a known technique that is applicable to the base device. Mitsui teaches a separate “input unit” to a signal to another unit. Mitsui, [0046] discloses “The input unit 150 is formed of input devices such as a keyboard, a touch panel, and various kinds of switches, and outputs, to the control unit 140, input signals generated in accordance with operation made to these input devices from the outside.” One of ordinary skill in the art would have recognized that applying the known technique of connecting an input unit to another unit (control unit 140 of Mitsui, or medical information processing apparatus 20 of Iwamura) would have yielded predictable results and resulted in an improved system capable of taking input signals from various input devices.
The combination of Iwamura and Mitsui does not explicitly teach “wherein the device is configured such that recorded data other than the selected portion is not transmitted from the device in response to the query, thereby reducing bandwidth and storage space needed for providing data in response to the query.”
However, in an analogous field of endeavor, Shinagawa discloses “wherein the device is configured such that recorded data other than the selected portion is not transmitted from the device in response to the query, thereby reducing bandwidth and storage space needed for providing data in response to the query” (Shinagawa, [0066] discloses “In such implementation environments, it can be important to reduce or limit the volume of data that is transmitted over the network 804, for example due to limited bandwidth resources. Medical imaging data can be particularly large in terms of size, so it can be useful to reduce the transmission of medical imaging data over the network 804, where possible” and “In other words, in some examples, only that first portion 202-210 relevant to the first section F1-F3 that has been selected is retrieved from the remote storage 806. Accordingly, the overall volume of data that is transmitted over the network 804 may be reduced”).
It would have been obvious to one of ordinary skill in the art before the effective filing
date of the claimed invention to have modified the combination of Iwamura and Mitsui to incorporate the teachings of Shinagawa by storing only a portion of data relevant to a particular application. Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art. The scope and content of the prior art of Iwamura, Mitsui, and Shinagawa are in the same field of endeavor as that of the applicant’s invention; all cited prior art references are directed to obtaining, processing, and transmitting/storing medical imaging data. There were design incentives or market forces which would have prompted adaptation of the known device; Shinagawa, [0066] discloses “In such implementation environments, it can be important to reduce or limit the volume of data that is transmitted over the network 804, for example due to limited bandwidth resources. Medical imaging data can be particularly large in terms of size, so it can be useful to reduce the transmission of medical imaging data over the network 804, where possible.” Thus, there is an incentive to reduce a transmitted volume of data due to limited bandwidth resources. The differences between the claimed invention and the prior art were encompassed in a principle known in the art. Shinagawa teaches the known principle of only transmitting a relevant portion of data. One of ordinary skill in the art, in view of the identified design incentives, could have implemented the claimed variation of the prior art, and the claimed variation would have been predictable to one of ordinary skill in the art. That is, one of ordinary skill in the art could have implemented the variation of only retrieving a relevant portion of medical imaging data; Iwamura discloses displaying medical image data I11a I11b, and relevant image data I21a in Fig. 6. However, in view of the identified design incentives disclosed by Shinagawa, the claimed variation of outputting only a selected portion of data would have been predictable to one of ordinary skill in the art. Accordingly, the combination of Iwamura, Mitsui, and Shinagawa discloses the invention of Claim 1.
Regarding Claim 2, the combination of Iwamura, Mitsui, and Shinagawa discloses “The device as set forth in claim 1, wherein the recorded data comprise structured data comprising data fields indicating one or more of:
- a time, date, and/or duration of the performing of the function;
- a location of the performing of the function;
- a degree of usage or success of the function;
- at least one device, service, or functionality in the medical facility being active or inactive during the performing of the function;
- at least one device or person being present or absent during the performing of the function;
- a target of the function; and/or
- an operator of the device” (Iwamura, [0077] discloses “For example, when the medical image data I12 is data in a Digital Imaging and Communications in Medicine (DICOM) format, a DICOM tag of the medical image data I12 has recorded therein additional information such as patient information, the requesting department, the requesting medical doctor, the date and time of the image taking process, the name of the modality, the image taking method, the examined site, and the like. By referring to the DICOM tag, the model generating function 244 is able to obtain the additional information to the medical image data I12.”)
Regarding Claim 3, the combination of Iwamura, Mitsui, and Shinagawa teaches “The device as set forth in claim 1, further comprising an image acquisition apparatus as a functional unit, wherein a function of the device comprises taking image data of a scene within a room of the medical facility, in particular an operating room, an intensive care unit, a patient room, or an anesthetic recovery room using the image acquisition apparatus” (Iwamura, [0025] discloses “Further, the model storage circuitry 230 is configured to store therein a trained model provided with a function to specify relevant image data and an image processing process, on the basis of input information including medical image data and medical examination information”; where medical image data indicates image data of a scene within a room of a medical facility).
Regarding Claim 4, the combination of Iwamura, Mitsui, and Shinagawa teaches “The device as set forth in claim 1, further comprising: a machine-learning model (“MLM”), in particular an artificial intelligence entity (“AIE”), configured to receive an output of the functional unit as input and to automatically generate, based thereon, at least a portion of the recorded data” (Iwamura, [0028] discloses “Further, for example, the processing circuitry 240 is configured to cause the trained model to specify the relevant image data and the image processing process on the basis of the input information including the medical image data and the medical examination information, by reading and executing a program corresponding to the controlling function 245 from the storage circuitry 210”; where a trained model is a machine-learning model; where input information including medical image data is receiving an output of the functional unit as input. Iwamura, [0079] discloses “the machine learning engine learns the relationship between the input-side data and the output-side data, by using any of various types of algorithms such as deep learning, a neural network, a logistic regression analysis, a non-linear discriminant analysis, a Support Vector Machine (SVM), a random forest, a Naïve Bayes scheme, and the like. Further, the model generating function 244 is configured to store the generated trained model Ml into the model storage circuitry 230”; where trained model Ml is a machine-learning model, in particular an artificial intelligence entity).
Regarding Claim 7, the combination of Iwamura, Mitsui, and Shinagawa teaches “The device as set forth in claim 1, wherein the device comprises or consists of a medical instrument, in particular an endoscope” (Mitsui, [0033] discloses “The above-described imaging system 1 is applied to, for example, an endoscope system that images inside of a lumen of a living body and displays an image of the inside of the lumen.”)
Regarding Claim 12, Claim 12 recites a method with steps corresponding to the elements of the system recited in Claims 1. Therefore, the recited steps of this claim are mapped to the proposed combination in the same manner as the corresponding elements in its corresponding system claim. Additionally, the rationale and motivation to combine the Iwamura, Mitsui, and Shinagawa references, presented in rejection of Claim 1, apply to this claim.
Regarding Claim 13, the combination of Iwamura, Mitsui, and Shinagawa teaches “The method as set forth in claim 12, further comprising the steps of:
generating the query for the data” (Mitsui, [0076] discloses “In the case where a request signal to perform the special light imaging is received from the input unit 150 during execution of the normal light imaging, the special light imaging is performed in a next frame”; where an input unit 150 is an input interface; where a request signal to perform special light imaging is a query for data);
transmitting the query to at least one device of a plurality of devices” (Mitsui, [0103] discloses “During this time, in the case where a command signal to command execution of the special light imaging is received from an input unit 150, a control unit 140 causes an imaging unit 11 and a light source unit 12 to perform the special light imaging in a next frame of the timing at which the command signal is received”; where an imaging unit and a light source unit are a plurality of devices);
receiving at least one output signal in response to the query” (Iwamura, [0028] discloses “Further, for example, the processing circuitry 240 is configured to output, to the terminal device 50, such a piece of image data from among the pieces of image data stored in the image storage circuitry 220 that corresponds to the request from the terminal device 50, by reading and executing a program corresponding to the output function 246 from the storage circuitry 210”; where an output piece of image data is an output signal); “and
generating a data structure in response to the query based on the received output signals” (Iwamura, [0087] discloses “Subsequently, the evaluating function 242 is configured to give an evaluation to the relevant image data I23 and the image processing process A13 specified by the trained model M1. More specifically, the evaluating function 242 gives the evaluation indicating how appropriate the relevant image data I23 and the image processing process A13 specified by the trained model M1 were, for the interpretation of the medical image data I13”; where image data and corresponding evaluation is a data structure). The proposed combination as well as the motivation for combining the Iwamura, Mitsui, and Shinagawa references presented in the rejection of Claim 1, apply to Claim 13 and are incorporated herein by reference. Thus, the apparatus recited in Claim 13 is met by Iwamura, Mitsui, and Shinagawa.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Iwamura et al. (US 2020/0193595 A1) in view of Mitsui et al. (US 2017/0112356 A1), further in view of Shinagawa et al. (US 2023/0033783 A1), further in view of Yu (US 2019/0183451 A1).
Regarding Claim 8, the combination of Iwamura, Mitsui, and Shinagawa does not explicitly teach the device of Claim 8.
However, in an analogous field of endeavor, Yu discloses “The device as set forth in claim 1, wherein the data processor is further configured to post- process and/or anonymize the recorded data in accordance with requirements of the query and/or requirements of a data policy of the medical facility” (Yu, [0018] discloses “Anonymization of medical image data may be a compliance requirement for transferring or accessing medical data. After being collected or acquired, medical data may be anonymized locally, e.g. by a hospital network, and then transferred to external systems, such as a cloud, for storage or future access”; where anonymizing locally by a hospital network is anonymizing recorded data in accordance with requirements of a data policy of the medical facility).
It would have been obvious to one of ordinary skill in the art before the effective filing
date of the claimed invention to have modified the combination of Iwamura, Mitsui, and Shinagawa to incorporate the teachings of Yu by anonymizing medical image data. The prior art Iwamura contained a ‘base’ device upon which the claimed invention can be seen as an ‘improvement’; Iwamura teaches a medical information processing apparatus including using medical image for training models. The claimed invention requires post-processing and/or anonymizing recorded data in accordance with requirements of the query and/or requirements of a data policy of the medical facility. The prior art Yu contained a known technique (anonymizing medical data) that is applicable to the base device. One of ordinary skill in the art would have recognized that applying the known technique of anonymizing medical data locally would have yielded predictable results and resulted in an improved system; it would have been obvious to one of ordinary skill in the art that applying the anonymizing of Yu to the teachings of Iwamura would enable transfer to external systems such as a cloud, as disclosed by Yu. Accordingly, the combination of Iwamura, Mitsui, Shinagawa, and Yu discloses the invention of Claim 8.
Allowable Subject Matter
Claims 5, 6, 9-11, and 14 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
Regarding Claim 5, although the use of machine learning algorithms in medical imagining applications is known in the art (Fouts et al. US 2022/0265121 A1), [0202] discloses “Once the image frames have been generated at the GPU at 304, the classifiers can be applied to the images so as to ultimately determine what conditions (if any) are present in a given image or video”), none of the previously cited prior art explicitly teaches a machine learning model configured to generate a portion of the recorded data, the recorded data being data pertaining to the function of the device and recorded by a data recorder. That is, although Fouts teaches a classifier that classifies conditions in an endoscopic video, Fouts, nor any of the previously cited prior art, explicitly teach generating a select portion of the recorded data based on the object classification of the MLM.
None of the previously cited references, alone or in combination, provide a motivation to teach the ordered combination of “The device as set forth in claim 4, wherein the MLM is configured to receive at least a portion of image data taken by an image acquisition apparatus of the device as input and to determine and classify at least one object therein and to generate a portion of the recorded data based thereon.”
Regarding Claim 6, although Sukkau discloses generating labelled training samples (Sukkau, [0112] discloses “In act S500, the generated sets are labeled with the corresponding determined total RSC to generate training samples”; where RSC is “relative substance composition” (see Abstract); where generating sets with labels is generating an output signal with a data field of the recorded data being used as labels), Sukkau does not explicitly teach outputting the output signal in response to a query for training data for machine learning, and there is no motivation in the cited prior art to combine the teachings of Iwamura and Sukkau to teach outputting an output signal comprising training data with entries of at least one data field of the recorded data being used as labels. Additionally, although Iwamura teaches using relevant image data as “output-side data” to generate a trained model (Iwamura, [0079] discloses “More specifically, the model generating function 244 inputs, to a machine learning engine, the medical image data I12 and the medical examination information T12 as input-side data, and the relevant image data I22 and the image processing process A12 as output-side data”), Iwamura does not explicitly teach labels of the recorded data, and does not explicitly teach receiving a query for training data for machine learning.
Thus, none of the previously cited prior art references, alone or in combination, provide a motivation to teach the ordered combination of “The device as set forth in claim 1, wherein the input interface is configured to receive a query for training data for machine learning, and wherein the output signal comprises training data with entries of at least one data field of the recorded data being used as labels.”
Regarding Claim 9, although Juergens teaches a storage device storing a plurality of images or video data captured with multiple endoscopes (Juergens, [0045] discloses “The mass storage device 112 stores a plurality of individual images and/or video data that were captured with endoscopes during procedures or examinations and from which training data are to be created as a basis for machine learning for various applications in the field of image evaluation in endoscopy”), Juergens does not explicitly teach a query controller as recited in Claim 9. That is, although the combination of the combination of Iwamura, Mitsui, and Shinagawa teaches the device of Claim 1, none of the previously cited prior art provides a motivation to teach “a plurality of devices according to claim 1,” nor does the cited prior art explicitly teach “a query controller configured to” receive requests, transmit queries, and receive output signals from the plurality of devices as required by Claim 9.
Thus, none of the previously cited prior art references, alone or in combination, provides a motivation to teach the ordered combination of “A data management system, comprising: a plurality of devices according to claim 1; and a query controller configured to receive a request for data and to generate and transmit a query for the data according to the received request to at least one device of the plurality of devices ;wherein the query controller is further configured to receive output signals of the plurality of devices and to provide data according to the received request based on the received output signals.”
Claims 10 and 11 depend directly or indirectly from Claim 9 and thus contain all allowable subject matter of Claim 9.
Regarding Claim 14, Claim 14 recites a method with steps corresponding to the elements of the system recited in Claim 6. Therefore, Claim 14 contains all allowable subject matter of Claim 6.
Conclusion
THIS ACTION IS MADE FINAL. 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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/CAROLINE TABANCAY DUFFY/Examiner, Art Unit 2662
/AMANDEEP SAINI/Supervisory Patent Examiner, Art Unit 2662
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