Detailed Notice
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of Claims
Claims 1-31 are currently pending.
Claims 1-16, 18- 21, 25-26, and 28 are amended.
Claims 1-31 are rejected.
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 1-31 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Step 1:
In the instant case, claims 1-15 are directed toward a device (i.e., machine), claims 16-24 are directed toward a method (i.e., process), and claims 25-31 are directed toward a non-transitory computer-readable medium (i.e., manufacture). Thus, each of the claims falls within one of the four statutory categories. Nevertheless, the claims fall within the judicial exception of an abstract idea.
Step 2A—Prong 1:
Independent claims 1, 16, and 25 recites steps that, under their broadest reasonable interpretations, cover performance of the limitations of a certain method of organizing human activity but for the recitation of generic computer components.
Claim 1 recites: “A system for cancer related pathology, comprising: a memory configured to store instructions; an image information module comprising a scanner and a camera; wherein the scanner is configured to determine scannable codes corresponding to a case identifier to uniquely identify information associated with a biopsy sample processed to create sample slides; and one or more processors configured to, when executing the instructions stored in the memory, cause the device to: identify the biopsy sample by scanning a requisition form having the case identifier, wherein the scanning causes the camera to begin a video recording at a technician station; receive system activity information corresponding to the technician station; wherein the video recording comprises an action or a sequence of actions performed by a technician relating to preparation, processing, examination, or digitizing of the biopsy sample, for determining pathology; wherein the digitizing creates a digital copy of each of the sample slides; and wherein the system activity information comprises the video recording and the digital copies of the sample slides; identify attributes and overarching patterns in the sample slides using one or more neural networks (NNs); monitor the system activity information to detect a breach in biopsy sample processing standards; apply the system activity information and an indication of the breach as input information to the one or more (NNs), the NNs being trained using historical system activity information, historical breaches in biopsy sample processing standards, and suitable remedies for the historical breaches; determine, based on an output of the one or more NNs, an appropriate remedy for the breach; execute the appropriate remedy for the breach; and verify, based on additional system activity information received after execution of the appropriate remedy, that the breach has been remedied”.
The limitations of determine scannable codes corresponding to a case identifier to uniquely identify information associated with a biopsy sample processed to create sample slides; identify the biopsy sample; an action or sequence of actions performed by a technician relating to preparation, processing, examination, or digitizing of the biopsy sample, for determining pathology; wherein the digitizing creates a digital copy of each of the sample slides; and wherein the system activity information comprises the video recording and the digital copies of the sample slides; identify attributes and overarching patterns in the sample slides; monitor the system activity information to detect a breach in biopsy sample processing standards; apply the system activity information and an indication of the breach as input information… using historical system activity information, historical breaches in biopsy sample processing standards, and suitable remedies for the historical breaches; determine, an appropriate remedy for the breach; execute the appropriate remedy for the breach; and verify, based on additional system activity information received after execution of the appropriate remedy, that the breach has been remedied., given the broadest reasonable interpretation, cover the abstract idea of a certain method of organizing human activity because they recite managing personal behavior or relationships or interactions between people (i.e. social activities, teaching, and following rules or instructions—in this case the aforementioned steps recite a process of determine, identify, actions, monitor, using, and execute, which is properly interpreted as a “personal behavior”), but instead automates the process via a computer model, e.g. see MPEP 2106.04(a)(2). Any limitations not identified above as part of the abstract idea are deemed “additional elements”, and will be discussed in further detail below.
Further, the abstract idea of claim 25 is identical as the abstract idea of claims 1 and 16. This limitation, given the broadest reasonable interpretation, also falls under the abstract idea of a certain method of organizing human activity because it recites managing personal behavior or relationships or interactions between people.
Additionally, claim 16 recites: “A method for cancer related pathology, performed by a device, comprising: scanning a scannable code via a scanner of an image information module, the scannable code corresponding to a case identifier to uniquely identify information associated with a biopsy sample; recording a video recording via a camera of the image information module of an action or a sequence of actions performed by a technician relating to preparation, processing, examination, or digitizing of the biopsy sample, for determining pathology; wherein the digitizing creates a digital copy of each of the sample slides; receiving system activity information corresponding to the technician at a technician station, wherein the system activity information comprises the video recording and the digital copies of the sample slides; identifying attributes and overarching patterns in the sample slides using one or more neural networks (NNs);monitoring the system activity information to detect a breach in biopsy sample processing standards; applying the system activity information and an indication of the breach as input information to the one or more (NNs), the NNs being trained using historical technician performance information, historical breaches in sample processing standards, and suitable remedies for the historical breaches; determining, based on an output of the one or more NNs, an appropriate remedy for the breach; dynamically generating a prompt comprising an indication of the breach and the remedy and cause a technician terminal, at the technician station, to generate the prompt; and verifying, based on additional technician performance information received after generating the prompt, that the breach has been remedied”.
The limitations of uniquely identify information associated with a biopsy sample; recording… of the image information module of an action or a sequence of actions performed by a technician relating to preparation, processing, examination, or digitizing of the biopsy sample, for determining pathology; wherein the digitizing creates a digital copy of each of the sample slides; receiving system activity information corresponding to the technician at a technician station, wherein the system activity information comprises the video recording and the digital copies of the sample slides; identifying attributes and overarching patterns in the sample slides; monitoring the system activity information to detect a breach in biopsy sample processing standards; applying the system activity information and an indication of the breach as input information… using historical technician performance information, historical breaches in sample processing standards, and suitable remedies for the historical breaches; determining, an appropriate remedy for the breach; dynamically generating a prompt comprising an indication of the breach and the remedy and cause a technician terminal, at the technician station, to generate the prompt; and verifying, based on additional technician performance information received after generating the prompt, that the breach has been remedied, given the broadest reasonable interpretation, cover the abstract idea of a certain method of organizing human activity because they recite managing personal behavior or relationships or interactions between people (i.e. social activities, teaching, and following rules or instructions—in this case the aforementioned steps recite a process of identify, recording, digitizing, monitoring, using, generating, and verifying, which is properly interpreted as a “personal behavior”), but instead automates the process via a computer model or machine learning, e.g. see MPEP 2106.04(a)(2). Any limitations not identified above as part of the abstract idea are deemed “additional elements”, and will be discussed in further detail below.
Dependent claims 2-15, 17-24, and 26-31 include other limitations, for example:
Claims 8 and 18 recite an additional element of a “printer”;
Claims 9 and 19 recite additional elements of “camera”;
Claim 10 recite creating and scanning, which add further to the abstract idea;
Claims 11, 21, and 28 recite reparation, processing, examination, digitizing, accessioning, grossing, tissue processing, cutting and embedding, and/or staining, which add further to the abstract idea;
as well as specific step of data to be processed, received, and applied, but these only serve to further limit the abstract idea and do not add and additional elements, and hence are nonetheless directed towards fundamentally the same abstract idea as independent claims 1, 16, and 25. However, recitation of an abstract idea is not the end of the 35 U.S.C. 101 analysis. Each of the claims must be analyzed for additional elements that indicate the abstract idea is integrated into a practical application to determine whether the claim is considered to be “directed to” an abstract idea.
Step 2A—Prong 2:
Claims 1-31 are not integrated into a practical application because the additional elements (i.e. any limitations that are not identified as part of the abstract idea) amount to no more than limitations which:
Amount to mere instructions to apply an exception—for example, the recitation of “memory”, “anode”, “processors”, “server device”, “neural networks (NNs)”, “image information module”, “scanner device”, “camera”, “printer”, “scannable code device”, and “non-transitory computer-readable medium”, which amount to merely invoking a computer as a tool to perform the abstract idea, e.g. see FIG. 1, FIG. 2, [0032]-[0034], [0092], and [0094], of the present specification, and see further MPEP 2106.05(f);
Generally linking the abstract idea to a particular technological environment or field of use, for example, “non-transitory, computer-readable medium comprising: one or more instructions that when executed by one or more processors cause the one or more processors to”, “a memory configured to store instructions; an image information module comprising a scanner and a camera; wherein the scanner is configured to”, “and one or more processors configured to, when executing the instructions stored in the memory, cause the device to”, “by scanning a requisition form having the case identifier, wherein the scanning causes the camera to begin a video recording at a technician station”, “wherein the video recording comprises an action or a sequence of”, “using one or more neural networks (NNs)”, “to the one or more (NNs), the NNs being trained”, “based on an output of the one or more NNs”, “scanning a scannable code via a scanner of an image information module, the scannable code corresponding to a case identifier to”, and “a video recording via a camera”, which amounts to limiting the abstract idea to the field of technology/the environment of computers, see MPEP 2106.05(h); and/or
Merely acquiring information for further analysis by the system and the particular manner of acquisition is not described or shown to be important, for example, “receive system activity information corresponding to the technician station”, which amounts to insignificant extra-solution activity in the form of mere data gathering because it merely functions tangentially to the main idea of the invention and serves only to bring in the data necessary for the inventions main analysis, see MPEP 2106.05(g).
Additionally, dependent claims 2-15, 17-24, and 26-31 include other limitations, but as stated above, the limitations recited by these claims do not include any additional elements beyond those already recited in independent claims 1, 16, and 25, and hence also do not integrate the aforementioned abstract idea into a practical application.
Step 2B:
The claims do not include additional elements that are sufficient to amount to “significantly more” than the judicial exception because the additional elements (i.e. the elements other than the abstract idea), as stated above, are directed towards no more than limitations that amount to mere instructions to apply the exception, and/or generally link the abstract idea to a particular technological environment or field of use, which even when reevaluated under the considerations of Step 2B of the analysis, do not amount to “significantly more” than the abstract idea.
Dependent claims 2-15, 17-24, and 26-31 include other limitations, but none of these limitations are deemed significantly more than the abstract idea because, as stated above, the aforementioned dependent claims do not recite any additional elements not already recited in independent claims 1, 16, and 25, and hence do not amount to “significantly more” than the abstract idea.
Additionally, the additional elements (i.e., “receive system activity information corresponding to the technician station”), add extra solution activity, which comprises limitations which amount to elements that have been recognized as well-understood, routine, and conventional activity in a particular field as demonstrated by:
Relevant court decisions (See MPEP 2106.05(d)(II)):
Receiving or transmitting data over a network, e.g., using the Internet to gather data, Symantec, 838 F.3d at 1321, 120 USPQ2d at 1362 (utilizing an intermediary computer to forward information); TLI Communications LLC v. AV Auto. LLC, 823 F.3d 607, 610, 118 USPQ2d 1744, 1745 (Fed. Cir. 2016) (using a telephone for image transmission); OIP Techs., Inc., v. Amazon.com, Inc., 788 F.3d 1359, 1363, 115 USPQ2d 1090, 1093 (Fed. Cir. 2015) (sending messages over a network); buySAFE, Inc. v. Google, Inc., 765 F.3d 1350, 1355, 112 USPQ2d 1093, 1096 (Fed. Cir. 2014) (computer receives and sends information over a network); but see DDR Holdings, LLC v. Hotels.com, L.P., 773 F.3d 1245, 1258, 113 USPQ2d 1097, 1106 (Fed. Cir. 2014) (“Unlike the claims in Ultramercial, the claims at issue here specify how interactions with the Internet are manipulated to yield a desired result‐‐a result that overrides the routine and conventional sequence of events ordinarily triggered by the click of a hyperlink.” (emphasis added)).
Thus, taken alone, the additional elements do not amount to significantly more than the abstract idea identified above. Furthermore, looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually, and there is no indication that the combination of elements improves the functioning of a computer or improves any other technology, and their collective functions merely provide conventional computer implementation.
Therefore, whether taken individually or as an ordered combination, claims 1-31 are nonetheless rejected under 35 U.S.C. 101 as being directed to non-statutory subject matter.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1-31 are rejected under 35 U.S.C. 103 as being unpatentable over Cummings (US 20230061099 A1), in view of Evans et al. (US 20160085913 A1), hereinafter Evans.
Regarding claim 1 Cummings teaches a system for cancer related pathology, comprising: a memory configured to store instructions (Cummings, [0145], [0147]-[0148], [0156], and [0159]); and one or more processors configured to, when executing the instructions stored in the memory, cause the device to (Cummings, [0145], [0147]-[0148], [0156], and [0159]): receive system activity information corresponding to a technician station (Cummings, [0145], [0147]-[0148], [0156], and [0159]); monitor the system activity information to detect a breach in sample processing standards (Cummings, [0070], [0111], [0115], [0132], [0135], and [0138]); apply the system activity information and an indication of the breach as input information to the one or more neural NNs, the NNs being trained using historical system activity information, historical breaches in sample processing standards, and suitable remedies for the historical breaches (Cummings, [0110]-[0115], [0133], [0181], and [0250]); determine, based on an output of the one or more NNs, an appropriate remedy for the breach; execute the appropriate remedy for the breach (Cummings, [0017], [0092], [0131], [0133], and [0137]-[0138]); and verify, based on additional system activity information received after execution of the appropriate remedy, that the breach has been remedied (Cummings, [0017], [0092], [0131], [0133], and [0137]-[0138]).
Cummings does not teach the sample is a biopsy sample, an image information module comprising a scanner and a camera; wherein the scanner is configured to determine scannable codes corresponding to a case identifier to uniquely identify information associated with a biopsy sample processed to create sample slides; identify the biopsy sample by scanning a requisition form having the case identifier, wherein the scanning causes the camera to begin a video recording at a technician station; wherein the video recording comprises an action or a sequence of actions performed by a technician relating to preparation, processing, examination, or digitizing of the biopsy sample, for determining pathology; wherein the digitizing creates a digital copy of each of the sample slides; and wherein the system activity information comprises the video recording and the digital copies of the sample sliders; identify attributes and overarching patterns in the sample slides using one or more neural networks (NNs).
However, Evans teaches the sample is a biopsy sample (Evans, FIG. 5, [0051]: “LDP may include a secure connection to an EMR 90 or lab information system (LIS) with access limited to the data required for recording the biopsy samples”, and [0076]: “FIG. 5 is a sample screen shot that may be used to provide graphical input for recording biopsy specimens taking using the system”), an image information module comprising a scanner and a camera (Evans, [0006]: “the clinic SIS is comprised of a housing for a portable computing device with a touch-sensitive screen and keyboard, a removable cover for the portable computer's keyboard, a digital camera, and one or more storage areas for magazines containing standard cassettes used for biopsy specimens”); wherein the scanner is configured to determine scannable codes corresponding to a case identifier to uniquely identify information associated with a biopsy sample processed to create sample slides (Evans, [0007]:“ Images may be associated with data entered via the touch screen or keyboard, or drawn from other databases, including patient data that is then associated with the identifier of the cassette into which the biopsy specimen is placed.”, [0011]: “A biopsy may be associated with a unique identifier of a container securing the biopsy in response to receiving the confirmation. The biopsy information and the patient information may be linked in the biopsy system. The linking of this data may be performed at the geographic location where the biopsy is performed. The patient clinical data and tissue-biopsy data may also be linked to any other type of physical specimen: genetic, blood, fluid, or other solid specimen data taken during the patient encounter”, [0012]: “The system may further include a scanning device (e.g. a camera or other digital imaging device) in communication with the computing device configured to image a biopsy. The biopsy may be placed into a container with a unique identifier, wherein the computing device may associate container identifier(s) with the patient information and with the scanner-collected/calculated data”, and [0012]: “The system may further include a scanning device (e.g. a camera or other digital imaging device) in communication with the computing device configured to image a biopsy. The biopsy may be placed into a container with a unique identifier, wherein the computing device may associate container identifier(s) with the patient information and with the scanner-collected/calculated data”); identify the biopsy sample by scanning a requisition form having the case identifier, wherein the scanning causes the camera to begin a video recording at a technician station (Evans, [0015]: “The data from this gross examination embodiment may be associated with the SIS encounter information and then integrated with any form of patient, hospital, research, clinic, or laboratory database”, [0039]: “The computer 103 may include an application, program, operating system, kernel, or set of instructions that is configured to record patient information and data, store and communicate images, and manage the initial generation of an electronic record associated with the specimen obtained during the biopsy. For example, the computer 103 may display a user interface utilized by the medical professional performing the biopsy, a medical assistant (e.g. nurse or practitioner assistant), or other user. In one embodiment, the computer 103 may be integrated with the scanner 104”, [0048]: “the fact is that tissue laboratories are temporally and geographically removed from the patient and staff who procured the biopsy, and as such must rely on written information on the specimen bottle and requisition paper to identify the source of the specimen”, and [0095]: “The text or image accession information is processed in the single-board computer capturing the accession identifier, typically in the form of a bar code. The accession identifier captured by the lab SIS can be immediately uploaded to the data storage in the system's cloud 1240 via the internet where it is associated with all other information associated with the patient, procedure, and other relevant data captured at all prior stages that comprise the system and method”); wherein the video recording comprises an action or a sequence of actions performed by a technician relating to preparation, processing, examination, or digitizing of the biopsy sample, for determining pathology (Evans, [0030]: “The tissue may be visually and for histochemically examined by a pathologist or other designated medical professional. The illustrative embodiments utilize digital imaging and cloud-based information technology to create a safer, more efficient process for specimen handling and for the documentation of associated clinical information and specific physical characteristics of the tissue at the time of the biopsy”, [0033]: “The illustrative embodiments enhance patient safety while increasing the efficiency and accuracy for production and processing of tissue biopsy slides”, [0035], and [0074]); wherein the digitizing creates a digital copy of each of the sample slides (Evans, [0069]: “The digital imaging device records on a single image the cassette, including the accession identifier, such as a bar-code, and an image of the specimen itself” and [0079]: “indentation 630 at the base of the cassette magazine allows the magazine to sit securely within the magazine storage bays which, in the case of the bay for the active magazine, further ensures that the specimen and cassette being photographed are held stationary while a digital image is taken”); and wherein the system activity information comprises the video recording and the digital copies of the sample sliders (Evans, [0069]: “A digital imaging device 355 is located in a fixed mount positioned over the cassette magazine currently being used, the image device being connected to the computing device and controlled by means of keyboard, touchscreen, voice-activation or other instruction sequences. The digital imaging device records on a single image the cassette, including the accession identifier, such as a bar-code, and an image of the specimen itself” and [0079]: “indentation 630 at the base of the cassette magazine allows the magazine to sit securely within the magazine storage bays which, in the case of the bay for the active magazine, further ensures that the specimen and cassette being photographed are held stationary while a digital image is taken”); identify attributes and overarching patterns in the sample slides using one or more neural networks (NNs) (Evans, [0010]: “The system may generate, from the image of the specimen other relevant data, including the dimensions of the specimens and the cross section area of specimens, insuring that the specimens are sufficiently representative to provide for accurate analysis”, [0032]: “tissue transfer and container labeling, the cost and risk of error is significantly reduced compared with any existing pre-analytic specimen handling process”, [0060], and [0086]: “The image may be stored locally and/or also automatically uploaded to a cloud-based server via wired or wireless network and associated with other relevant data relating to the patient or the procedure. Immediate storage of the relevant data is later retrieved during the analysis of specimens thus insuring that no transcription errors result in misidentification of patents, tissue specimens, or other critical elements”.
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify Cummings to incorporate the teachings of Evans and account for an integrated solution that automates manual tasks, eliminates duplicative efforts, and reduces the probability of errors during the process of taking and documenting multiple types of specimens (Evans, Abstract and [0004]).
Regarding claim 2 Cummings further teaches the sample processing standards comprise at least one of: one or more operational performance thresholds, one or more operational performance patterns, one or more information content requirements, one or more information content patterns, one or more information quality thresholds, one or more information quality patterns, one or more device functionality thresholds, one or more device functionality patterns, one or more technical performance thresholds, one or more technical performance patterns, or one or more operational conditions (Cummings, [0129]-[0132], and [0135]).
Regarding claim 3 Cummings further teaches the system activity information comprises at least one of: information associated with technician conduct, information associated with a performance of one or more devices, or information associated with a performance of one or more software processes (Cummings, [0106], [0151], [0181], and [0287]).
Regarding claim 4 Cummings further teaches detecting a breach may include determining that the system activity information does not comply with one or more sample processing standards (Cummings, [0020] and [0365]).
Cummings does not teach the sample is a biopsy sample.
However, Evans teaches the sample is a biopsy sample (Evans, FIG. 5, [0051]: “LDP may include a secure connection to an EMR 90 or lab information system (LIS) with access limited to the data required for recording the biopsy samples”, and [0076]: “FIG. 5 is a sample screen shot that may be used to provide graphical input for recording biopsy specimens taking using the system”).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify Cummings to incorporate the teachings of Evans and account for an integrated solution that automates manual tasks, eliminates duplicative efforts, and reduces the probability of errors during the process of taking and documenting multiple types of specimens (Evans, Abstract and [0004]).
Regarding claim 5 Cummings further teaches the appropriate remedy comprises at least one of: notifying a technician of the breach, providing the technician with one or more instructions regarding the breach, pausing, canceling, undoing, or redoing one or more device operations, dynamically altering or updating one or more device operations, dynamically updating one or more electronic records, causing one or more device operations to be performed by one or more other devices, or creating a record of the system activity information, the breach, and the remedy (Cummings, [0072], [0074], [0111], [0116], [0131]-[0132], and [0151]).
Regarding claim 6 Cummings further teaches the one or more processors may be configured to: monitor the monitor the system activity information to detect a breach in sample processing standards by: applying the system activity information as input to a sample processing standards NN, the sample processing standards NN being trained on historical system activity information, historical breaches in sample processing standards, and historical sources of breaches in sample processing standards; and the sample processing standards NN being configured to provide an indication of whether one or more aspects of the system activity information amounts to one or more breaches in sample processing standards (Cummings, [0110]-[0115], [0133], [0181], and [0250]).
Regarding claim 7 Cummings further teaches the device comprises at least one of: a technician terminal, one or more laboratory information system (LIS) servers, or a combination of the technician terminal and the one or more laboratory information system (LIS) servers (Cummings, [0145], [0147]-[0148], [0156], [0159], and [0304]).
Regarding claim 8 Cummings does not teach the device further comprises a printer configured to print the scannable codes.
However, Evans teaches the device further comprises a printer configured to print the scannable codes (Evans, [0010]: “The lab SIS comprises a holder that enables a paraffin embedded tissue cassette to easily slide under a fixed-mount camera, label reader, or other digital imaging device. The lab SIS captures the data imprinted upon the cassette, and based upon data previously associated with that specific cassette identifier directly prints any required number or variety of labels to be affixed to glass slides onto which sectioned portions of the specimens are placed for analysis”, [0040]-[0042]: “This information may be saved in an electronic record associated with the patient and the cassette 106. In another embodiment, the patient's information may be printed in a label that is attached to the cassette”, and [0056]-[0063]: “medical professional may record an image or images of the biopsy sites (e.g. with an endoscopy camera). The system may scan the notes (handwritten or printed) or other images (step 246). For example, a document scanner may be utilized”).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify Cummings to incorporate the teachings of Evans and account for an integrated solution that automates manual tasks, eliminates duplicative efforts, and reduces the probability of errors during the process of taking and documenting multiple types of specimens (Evans, Abstract and [0004]).
Regarding claim 9 Cummings further teaches the system activity information comprise the technician performance information at least one of: video information captured by a camera regarding an action or sequence of actions performed by the technician at the technician station, an input or a sequence of inputs, by the technician, into one or more of the devices of the technician station, or an operation or sequence of operations performed by the one or more of the devices of the technician station (Cummings, [0292]-[0294] and [0299]-[0301]).
Regarding claim 10 Cummings does not teach the sample is a biopsy sample, the technician performance information comprises at least one of: creating a scannable code that uniquely identifies a biopsy case, scanning the scannable code that uniquely identifies a biopsy case, creating a scannable code that uniquely identifies a biopsy sample, scanning the scannable code that uniquely identifies a biopsy sample, creating a scannable code that uniquely identifies a sample slide, or scanning the scannable code that uniquely identifies a sample slide.
However, Evans teaches the sample is a biopsy sample(Evans, FIG. 5, [0051]: “LDP may include a secure connection to an EMR 90 or lab information system (LIS) with access limited to the data required for recording the biopsy samples”, and [0076]: “FIG. 5 is a sample screen shot that may be used to provide graphical input for recording biopsy specimens taking using the system”), the technician performance information comprises at least one of: creating a scannable code that uniquely identifies a biopsy case, scanning the scannable code that uniquely identifies a biopsy case, creating a scannable code that uniquely identifies a biopsy sample, scanning the scannable code that uniquely identifies a biopsy sample, creating a scannable code that uniquely identifies a sample slide, or scanning the scannable code that uniquely identifies a sample slide (Evans, [0040]-[0042] and [0056]-[0062]).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify Cummings to incorporate the teachings of Evans and account for an integrated solution that automates manual tasks, eliminates duplicative efforts, and reduces the probability of errors during the process of taking and documenting multiple types of specimens (Evans, Abstract and [0004]).
Regarding claim 11 Cummings does not teach the sample is a biopsy sample, preparation, processing, examination, or digitizing of the biopsy sample comprises at least one of the following: accessioning the biopsy sample, grossing the biopsy sample, tissue processing of the biopsy sample, cutting and embedding the biopsy sample, staining the biopsy sample, or digitizing the biopsy sample to create the digital copies of the sample slides.
However, Evans teaches the sample is a biopsy sample (Evans, FIG. 5, [0051]: “LDP may include a secure connection to an EMR 90 or lab information system (LIS) with access limited to the data required for recording the biopsy samples”, and [0076]: “FIG. 5 is a sample screen shot that may be used to provide graphical input for recording biopsy specimens taking using the system”), preparation, processing, examination, or digitizing of the biopsy sample comprises at least one of the following: accessioning the biopsy sample, grossing the biopsy sample, tissue processing of the biopsy sample, cutting and embedding the biopsy sample, staining the biopsy sample, or digitizing the biopsy sample (Evans, [0040]-[0042] and [0056]-[0062]) to create the digital copies of the sample slides (Evans, [0030]: “The tissue may be visually and for histochemically examined by a pathologist or other designated medical professional. The illustrative embodiments utilize digital imaging and cloud-based information technology to create a safer, more efficient process for specimen handling and for the documentation of associated clinical information and specific physical characteristics of the tissue at the time of the biopsy”, [0033]: “The illustrative embodiments enhance patient safety while increasing the efficiency and accuracy for production and processing of tissue biopsy slides”, [0035], and [0074]).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify Cummings to incorporate the teachings of Evans and account for an integrated solution that automates manual tasks, eliminates duplicative efforts, and reduces the probability of errors during the process of taking and documenting multiple types of specimens (Evans, Abstract and [0004]).
Regarding claim 12 Cummings further teaches the one or more processors are further configured to: create an electronic record of the technician performance information, the breach, the remedy, and whether the breach was remedied (Cummings, [0017], [0092], [0131], [0133], [0137]-[0138], [0147]-[0148], and [0181]).
Regarding claim 13 Cummings further teaches the record further comprises at least one of: a technician identifier that uniquely identifies the technician, a technician station identifier that uniquely identifies the technician station, a technician terminal identifier that uniquely identifies the technician terminal, a unique identifier of another device at the technician station, or a time and/or date of the breach (Cummings, [0058], [0061]-[0062], and [0188]).
Regarding claim 14 Cummings further teaches the one or more processors are further configured to: create an updated set of NN training data using the electronic record and a set of NN training data; and train the one or more NNs using the updated set of NN training data (Cummings, [0110]-[0115], [0133], [0181], and [0250]).
Regarding claim 15 Cummings further teaches the one or more processors are further configured to: use the one or more NNs to monitor subsequent technician performance information for patterns or conditions similar to those leading to the breach (Cummings, [0255], [0302] and [0316]-[0317]).
Regarding claim 16 Cummings teaches a method for cancer related pathology, performed by a device, comprising: receiving system activity information corresponding to the technician at a technician station (Cummings, [0145], [0147]-[0148], [0156], and [0159]); monitoring system activity information to detect a breach in sample processing standards (Cummings, [0070], [0111], [0115], [0132], [0135], and [0138]); applying system activity information and an indication of the breach as input information to the one or more NNs, the NNs being trained using historical technician performance information, historical breaches in sample processing standards, and suitable remedies for the historical breaches (Cummings, [0110]-[0115], [0133], [0181], and [0250]); determining, based on an output of the one or more NNs, an appropriate remedy for the breach (Cummings, [0017], [0092], [0131], [0133], and [0137]-[0138]); dynamically generating a prompt comprising an indication of the breach and the remedy and cause a technician terminal, at the technician station, to generate the prompt (Cummings, [0052], [0070], [0111], [0115], [0132], [0135], and [0138]); and verifying, based on additional technician performance information received after generating the prompt, that the breach has been remedied (Cummings, [0017], [0092], [0131], [0133], and [0137]-[0138]).
Cummings does not teach the sample is a biopsy sample, scanning a scannable code via a scanner of an image information module, the scannable code corresponding to a case identifier to uniquely identify information associated with a biopsy sample; recording a video recording via a camera of the image information module of an action or a sequence of actions performed by a technician relating to preparation, processing, examination, or digitizing of the biopsy sample, for determining pathology; wherein the digitizing creates a digital copy of each of the sample slides; wherein the system activity information comprises the video recording and the digital copies of the sample slides; identifying attributes and overarching patterns in the sample slides using one or more neural networks (NNs).
However, Evans teaches the sample is a biopsy sample (Evans, FIG. 5, [0051]: “LDP may include a secure connection to an EMR 90 or lab information system (LIS) with access limited to the data required for recording the biopsy samples”, and [0076]: “FIG. 5 is a sample screen shot that may be used to provide graphical input for recording biopsy specimens taking using the system”), scanning a scannable code via a scanner of an image information module, the scannable code corresponding to a case identifier to uniquely identify information associated with a biopsy sample (Evans, [0007]:“ Images may be associated with data entered via the touch screen or keyboard, or drawn from other databases, including patient data that is then associated with the identifier of the cassette into which the biopsy specimen is placed.”, [0011]: “A biopsy may be associated with a unique identifier of a container securing the biopsy in response to receiving the confirmation. The biopsy information and the patient information may be linked in the biopsy system. The linking of this data may be performed at the geographic location where the biopsy is performed. The patient clinical data and tissue-biopsy data may also be linked to any other type of physical specimen: genetic, blood, fluid, or other solid specimen data taken during the patient encounter”, [0012]: “The system may further include a scanning device (e.g. a camera or other digital imaging device) in communication with the computing device configured to image a biopsy. The biopsy may be placed into a container with a unique identifier, wherein the computing device may associate container identifier(s) with the patient information and with the scanner-collected/calculated data”, and [0012]: “The system may further include a scanning device (e.g. a camera or other digital imaging device) in communication with the computing device configured to image a biopsy. The biopsy may be placed into a container with a unique identifier, wherein the computing device may associate container identifier(s) with the patient information and with the scanner-collected/calculated data”); recording a video recording via a camera of the image information module of an action or a sequence of actions performed by a technician relating to preparation, processing, examination, or digitizing of the biopsy sample, for determining pathology (Evans, [0030]: “The tissue may be visually and for histochemically examined by a pathologist or other designated medical professional. The illustrative embodiments utilize digital imaging and cloud-based information technology to create a safer, more efficient process for specimen handling and for the documentation of associated clinical information and specific physical characteristics of the tissue at the time of the biopsy”, [0033]: “The illustrative embodiments enhance patient safety while increasing the efficiency and accuracy for production and processing of tissue biopsy slides”, [0035], and [0074]); wherein the digitizing creates a digital copy of each of the sample slides (Evans, [0069]: “The digital imaging device records on a single image the cassette, including the accession identifier, such as a bar-code, and an image of the specimen itself” and [0079]: “indentation 630 at the base of the cassette magazine allows the magazine to sit securely within the magazine storage bays which, in the case of the bay for the active magazine, further ensures that the specimen and cassette being photographed are held stationary while a digital image is taken”); wherein the system activity information comprises the video recording and the digital copies of the sample slides (Evans, [0069]: “The digital imaging device records on a single image the cassette, including the accession identifier, such as a bar-code, and an image of the specimen itself” and [0079]: “indentation 630 at the base of the cassette magazine allows the magazine to sit securely within the magazine storage bays which, in the case of the bay for the active magazine, further ensures that the specimen and cassette being photographed are held stationary while a digital image is taken”); identifying attributes and overarching patterns in the sample slides using one or more neural networks (NNs) (Evans, [0010]: “The system may generate, from the image of the specimen other relevant data, including the dimensions of the specimens and the cross section area of specimens, insuring that the specimens are sufficiently representative to provide for accurate analysis”, [0032]: “tissue transfer and container labeling, the cost and risk of error is significantly reduced compared with any existing pre-analytic specimen handling process”, [0060], and [0086]: “The image may be stored locally and/or also automatically uploaded to a cloud-based server via wired or wireless network and associated with other relevant data relating to the patient or the procedure. Immediate storage of the relevant data is later retrieved during the analysis of specimens thus insuring that no transcription errors result in misidentification of patents, tissue specimens, or other critical elements”).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify Cummings to incorporate the teachings of Evans and account for an integrated solution that automates manual tasks, eliminates duplicative efforts, and reduces the probability of errors during the process of taking and documenting multiple types of specimens (Evans, Abstract and [0004]).
Regarding claim 17 Cummings further teaches the device comprises at least one of: the technician terminal, one or more laboratory information system (LIS) servers, or a combination of the technician terminal and the one or more laboratory information system (LIS) servers (Cummings, [0145], [0147]-[0148], [0156], [0159], and [0304]).
Regarding claim 18 Cummings does not teach the device further comprises a printer configured to print the scannable codes.
However, Evans teaches the device further comprises a printer configured to print the scannable codes (Evans, [0010]: “The lab SIS comprises a holder that enables a paraffin embedded tissue cassette to easily slide under a fixed-mount camera, label reader, or other digital imaging device. The lab SIS captures the data imprinted upon the cassette, and based upon data previously associated with that specific cassette identifier directly prints any required number or variety of labels to be affixed to glass slides onto which sectioned portions of the specimens are placed for analysis”, [0040]-[0042]: “This information may be saved in an electronic record associated with the patient and the cassette 106. In another embodiment, the patient's information may be printed in a label that is attached to the cassette”, and [0056]-[0063]: “medical professional may record an image or images of the biopsy sites (e.g. with an endoscopy camera). The system may scan the notes (handwritten or printed) or other images (step 246). For example, a document scanner may be utilized”).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify Cummings to incorporate the teachings of Evans and account for an integrated solution that automates manual tasks, eliminates duplicative efforts, and reduces the probability of errors during the process of taking and documenting multiple types of specimens (Evans, Abstract and [0004]).
Regarding claim 19 Cummings further teaches system activity information comprises technician performance information comprising at least one of: video information captured by a camera regarding an action or sequence of actions performed by the technician at the technician station, an input or a sequence of inputs, by the technician, into one or more of the [[device]]devices of the technician station, or an operation or sequence of operations performed by one or more of the devices of the technician station (Cummings, [0292]-[0294] and [0299]-[0301]).
Regarding claim 20 Cummings does not teach the sample is a biopsy sample, the technician performance information comprises at least one of: creating a scannable code that uniquely identifies a biopsy case, scanning the scannable code that uniquely identifies a biopsy case, creating a scannable code that uniquely identifies a biopsy sample, scanning the scannable code that uniquely identifies a biopsy sample, creating a scannable code that uniquely identifies a sample slide, or scanning the scannable code that uniquely identifies a sample slide.
However, Evans teaches the sample is a biopsy sample(Evans, FIG. 5, [0051]: “LDP may include a secure connection to an EMR 90 or lab information system (LIS) with access limited to the data required for recording the biopsy samples”, and [0076]: “FIG. 5 is a sample screen shot that may be used to provide graphical input for recording biopsy specimens taking using the system”), the technician performance information comprises at least one of: creating a scannable code that uniquely identifies a biopsy case, scanning the scannable code that uniquely identifies a biopsy case, creating a scannable code that uniquely identifies a biopsy sample, scanning the scannable code that uniquely identifies a biopsy sample, creating a scannable code that uniquely identifies a sample slide, or scanning the scannable code that uniquely identifies a sample slide (Evans, [0040]-[0042] and [0056]-[0062]).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify Cummings to incorporate the teachings of Evans and account for an integrated solution that automates manual tasks, eliminates duplicative efforts, and reduces the probability of errors during the process of taking and documenting multiple types of specimens (Evans, Abstract and [0004]).
Regarding claim 21 Cummings does not teach the sample is a biopsy sample, the preparation, processing, examination, or digitizing of the biopsy sample comprises at least one of the following: accessioning the biopsy sample, grossing the biopsy sample, tissue processing of the biopsy sample, cutting and embedding the biopsy sample, staining the biopsy sample, or digitizing the biopsy sample to create the digital copies of the sample slides.
However, Evans teaches the sample is a biopsy sample(Evans, FIG. 5, [0051]: “LDP may include a secure connection to an EMR 90 or lab information system (LIS) with access limited to the data required for recording the biopsy samples”, and [0076]: “FIG. 5 is a sample screen shot that may be used to provide graphical input for recording biopsy specimens taking using the system”), the preparation, processing, examination, or digitizing of the biopsy sample comprises at least one of the following: accessioning the biopsy sample, grossing the biopsy sample, tissue processing of the biopsy sample, cutting and embedding the biopsy sample, staining the biopsy sample, or digitizing the biopsy sample (Evans, [0040]-[0042] and [0056]-[0062]) to create the digital copies of the sample slides (Evans, [0069]: “The digital imaging device records on a single image the cassette, including the accession identifier, such as a bar-code, and an image of the specimen itself” and [0079]: “indentation 630 at the base of the cassette magazine allows the magazine to sit securely within the magazine storage bays which, in the case of the bay for the active magazine, further ensures that the specimen and cassette being photographed are held stationary while a digital image is taken”).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify Cummings to incorporate the teachings of Evans and account for an integrated solution that automates manual tasks, eliminates duplicative efforts, and reduces the probability of errors during the process of taking and documenting multiple types of specimens (Evans, Abstract and [0004]).
Regarding claim 22 Cummings further teaches creating an electronic record of the technician performance information, the breach, the remedy, and whether the breach was remedied (Cummings, [0017], [0092], [0131], [0133], [0137]-[0138], [0147]-[0148], and [0181]).
Regarding claim 23 Cummings further teaches the record further comprises at least one of: a technician identifier that uniquely identifies the technician, a technician station identifier that uniquely identifies the technician station, a technician terminal identifier that uniquely identifies the technician terminal, a unique identifier of another device at the technician station, or a time and/or a date of the breach (Cummings, [0058], [0061]-[0062], and [0188]).
Regarding claim 24 Cummings further teaches creating an updated set of NN training data using the electronic record and a set of NN training data; training the one or more NNs using the updated set of NN training data; and using the one or more NNs to monitor subsequent technician performance information for patterns or conditions similar to those leading to the breach (Cummings, [0255], [0302] and [0316]-[0317]).
Regarding claim 25 Cummings teaches a non-transitory, computer-readable medium comprising: one or more instructions that when executed by one or more processors cause the one or more processors to: receive system activity information corresponding to a technician at a technician station (Cummings, [0145], [0147]-[0148], [0156], and [0159]); monitor system activity information to detect a breach in sample processing standards (Cummings, [0070], [0111], [0115], [0132], [0135], and [0138]); apply system activity information and an indication of the breach as input information to one or more NNs, the NNs being trained using historical technician performance information, historical breaches in sample processing standards, and suitable remedies for the historical breaches (Cummings, [0110]-[0115], [0133], [0181], and [0250]); determine, based on an output of the one or more NNs, an appropriate remedy for the breach (Cummings, [0017], [0092], [0131], [0133], and [0137]-[0138]); dynamically generate a prompt comprising an indication of the breach and the remedy and cause a technician terminal, at the technician station, to generate the prompt (Cummings, [0052], [0070], [0111], [0115], [0132], [0135], and [0138]); and verify, based on additional technician performance information received after generating the prompt, that the breach has been remedied (Cummings, [0017], [0092], [0131], [0133], and [0137]-[0138]).
Cummings does not teach receive and process input from one or more types of image or optical information via an image information module; register a biopsy sample processed to create sample slides with a laboratory information system by capturing a scannable code via a scanner of the image information module; wherein the biopsy sample is associated with a case identifier to unique identify information associated with the biopsy sample; wherein the system activity information comprises the image or optical information and digital copies of each of the sample slides; identify attributes and overarching patterns in the sample slides using one or more neural networks (NNs).
However, Evans teaches receive and process input from one or more types of image; wherein the system activity information comprises the image or optical information and digital copies of each of the sample slides or optical information via an image information module (Evans, [0006]: “the clinic SIS is comprised of a housing for a portable computing device with a touch-sensitive screen and keyboard, a removable cover for the portable computer's keyboard, a digital camera, and one or more storage areas for magazines containing standard cassettes used for biopsy specimens”); register a biopsy sample processed to create sample slides with a laboratory information system by capturing a scannable code via a scanner of the image information module (Evans, [0030]: “The tissue may be visually and for histochemically examined by a pathologist or other designated medical professional. The illustrative embodiments utilize digital imaging and cloud-based information technology to create a safer, more efficient process for specimen handling and for the documentation of associated clinical information and specific physical characteristics of the tissue at the time of the biopsy”, [0033]: “The illustrative embodiments enhance patient safety while increasing the efficiency and accuracy for production and processing of tissue biopsy slides”, [0035], and [0074]); wherein the biopsy sample is associated with a case identifier to unique identify information associated with the biopsy sample (Evans, [0015]: “The data from this gross examination embodiment may be associated with the SIS encounter information and then integrated with any form of patient, hospital, research, clinic, or laboratory database”, [0039]: “The computer 103 may include an application, program, operating system, kernel, or set of instructions that is configured to record patient information and data, store and communicate images, and manage the initial generation of an electronic record associated with the specimen obtained during the biopsy. For example, the computer 103 may display a user interface utilized by the medical professional performing the biopsy, a medical assistant (e.g. nurse or practitioner assistant), or other user. In one embodiment, the computer 103 may be integrated with the scanner 104”, [0048]: “the fact is that tissue laboratories are temporally and geographically removed from the patient and staff who procured the biopsy, and as such must rely on written information on the specimen bottle and requisition paper to identify the source of the specimen”, and [0095]: “The text or image accession information is processed in the single-board computer capturing the accession identifier, typically in the form of a bar code. The accession identifier captured by the lab SIS can be immediately uploaded to the data storage in the system's cloud 1240 via the internet where it is associated with all other information associated with the patient, procedure, and other relevant data captured at all prior stages that comprise the system and method”); wherein the system activity information comprises the image or optical information and digital copies of each of the sample slides (Evans, [0069]: “The digital imaging device records on a single image the cassette, including the accession identifier, such as a bar-code, and an image of the specimen itself” and [0079]: “indentation 630 at the base of the cassette magazine allows the magazine to sit securely within the magazine storage bays which, in the case of the bay for the active magazine, further ensures that the specimen and cassette being photographed are held stationary while a digital image is taken”); identify attributes and overarching patterns in the sample slides using one or more neural networks (NNs) (Evans, [0010]: “The system may generate, from the image of the specimen other relevant data, including the dimensions of the specimens and the cross section area of specimens, insuring that the specimens are sufficiently representative to provide for accurate analysis”, [0032]: “tissue transfer and container labeling, the cost and risk of error is significantly reduced compared with any existing pre-analytic specimen handling process”, [0060], and [0086]: “The image may be stored locally and/or also automatically uploaded to a cloud-based server via wired or wireless network and associated with other relevant data relating to the patient or the procedure. Immediate storage of the relevant data is later retrieved during the analysis of specimens thus insuring that no transcription errors result in misidentification of patents, tissue specimens, or other critical elements”).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify Cummings to incorporate the teachings of Evans and account for an integrated solution that automates manual tasks, eliminates duplicative efforts, and reduces the probability of errors during the process of taking and documenting multiple types of specimens (Evans, Abstract and [0004]).
Regarding claim 26 Cummings further teaches the system activity information further comprises at least one of: video information captured by a camera of the image information module, the video information regarding an action or sequence of actions performed by the technician at the technician station, an input or a sequence of inputs, by the technician, into one or more of the devices of the technician station, or an operation or sequence of operations performed by one or more of the devices of the technician station (Cummings, [0292]-[0294] and [0299]-[0301]).
Regarding claim 27 Cummings does not teach the sample is a biopsy sample, the technician performance information comprises at least one of: creating a scannable code that uniquely identifies a biopsy case, scanning the scannable code that uniquely identifies a biopsy case, creating a scannable code that uniquely identifies a biopsy sample, scanning the scannable code that uniquely identifies a biopsy sample, creating a scannable code that uniquely identifies a sample slide, or scanning the scannable code that uniquely identifies a sample slide.
However, Evans teaches the sample is a biopsy sample (Evans, FIG. 5, [0051]: “LDP may include a secure connection to an EMR 90 or lab information system (LIS) with access limited to the data required for recording the biopsy samples”, and [0076]: “FIG. 5 is a sample screen shot that may be used to provide graphical input for recording biopsy specimens taking using the system”), the technician performance information comprises at least one of: creating a scannable code that uniquely identifies a biopsy case, scanning the scannable code that uniquely identifies a biopsy case, creating a scannable code that uniquely identifies a biopsy sample, scanning the scannable code that uniquely identifies a biopsy sample, creating a scannable code that uniquely identifies a sample slide, or scanning the scannable code that uniquely identifies a sample slide (Evans, [0040]-[0042] and [0056]-[0062]).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify Cummings to incorporate the teachings of Evans and account for an integrated solution that automates manual tasks, eliminates duplicative efforts, and reduces the probability of errors during the process of taking and documenting multiple types of specimens (Evans, Abstract and [0004]).
Regarding claim 28 Cummings does not teach the sample is a biopsy sample, image of optical information comprises information relating to a technician performing at least one of the following: accessioning the biopsy sample, grossing the biopsy sample, tissue processing of the biopsy sample, cutting and embedding the biopsy sample, staining the biopsy sample, or digitizing the biopsy sample to create the digital copies of the sample slide.
However, Evans teaches the sample is a biopsy sample (Evans, FIG. 5, [0051]: “LDP may include a secure connection to an EMR 90 or lab information system (LIS) with access limited to the data required for recording the biopsy samples”, and [0076]: “FIG. 5 is a sample screen shot that may be used to provide graphical input for recording biopsy specimens taking using the system”), image of optical information comprises information relating to a technician performing at least one of the following: accessioning the biopsy sample, grossing the biopsy sample, tissue processing of the biopsy sample, cutting and embedding the biopsy sample, staining the biopsy sample, or digitizing the biopsy sample (Evans, [0040]-[0042] and [0056]-[0062]) to create the digital copies of the sample slides (Evans, [0030]: “The tissue may be visually and for histochemically examined by a pathologist or other designated medical professional. The illustrative embodiments utilize digital imaging and cloud-based information technology to create a safer, more efficient process for specimen handling and for the documentation of associated clinical information and specific physical characteristics of the tissue at the time of the biopsy”, [0033]: “The illustrative embodiments enhance patient safety while increasing the efficiency and accuracy for production and processing of tissue biopsy slides”, [0035], and [0074]).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify Cummings to incorporate the teachings of Evans and account for an integrated solution that automates manual tasks, eliminates duplicative efforts, and reduces the probability of errors during the process of taking and documenting multiple types of specimens (Evans, Abstract and [0004]).
Regarding claim 29 Cummings further teaches the one or more processors are further configured to: create an electronic record of the technician performance information, the breach, the remedy, and whether the breach was remedied (Cummings, [0017], [0092], [0131], [0133], [0137]-[0138], [0147]-[0148], and [0181]).
Regarding claim 30 Cummings further teaches the record further comprises at least one of: a technician identifier that uniquely identifies the technician, a technician station identifier that uniquely identifies the technician station, a technician terminal identifier that uniquely identifies the technician terminal, a unique identifier of another device at the technician station, or a time and/or a date of the breach (Cummings, [0058], [0061]-[0062], and [0188]).
Regarding claim 31 Cummings further teaches the one or more processors are further configured to: create an updated set of NN training data using the electronic record and a set of NN training data; train the one or more NNs using the updated set of NN training data; and use the one or more NNs to monitor subsequent technician performance information for patterns or conditions similar to those leading to the breach (Cummings, [0255], [0302] and [0316]-[0317]).
Response to Arguments
Applicant's arguments filed 12/22/2025 have been fully considered but they are not persuasive.
Regarding the 35 U.S.C. 101 Rejection, Applicant argues the amendments to claims do not recite an abstract idea of a certain method of human activity because of the amendments of “system for cancer related pathology”, “an image information module comprising a scanner and a camera”, “scanning a scannable code via a scanner of an image information module, the scannable code corresponding to a case identifier to uniquely identify information associated with a biopsy sample”, and “recording a video recording via a camera of the image information module of an action or a sequence of actions performed by a technician relating to preparation, processing, examination, or digitizing of the biopsy sample, for determining pathology; wherein the digitizing creates a digital copy of each of the sample slides”. Examiner respectfully disagrees. The “system”, “image information module”, “scanner”, and “camera” are all additional elements that are not part of the abstract idea. The method of scanning and recording are a part of the abstract idea because these are steps that a person can perform with a pen and paper, persons, or with a computer tool (See MPEP 2106.04(a)(2)II: “the sub-groupings encompass both activity of a single person (for example, a person following a set of instructions or a person signing a contract online) and activity that involves multiple people (such as a commercial interaction), and thus, certain activity between a person and a computer (for example a method of anonymous loan shopping that a person conducts using a mobile phone) may fall within the “certain methods of organizing human activity” grouping. It is noted that the number of people involved in the activity is not dispositive as to whether a claim limitation falls within this grouping. Instead, the determination should be based on whether the activity itself falls within one of the sub-groupings”). Using the “system”, “image information module”, “scanner”, and “camera” to perform the functions of scanning and recording falls under the abstract idea being applied/linked to the additional elements as shown in Prong 2 (See MPEP 2106.05(e): “In contrast, the claims in Alice Corp. v. CLS Bank International did not meaningfully limit the abstract idea of mitigating settlement risk. 573 U.S. 208, 110 USPQ2d 1976 (2014). In particular, the Court concluded that the additional elements such as the data processing system and communications controllers recited in the system claims did not meaningfully limit the abstract idea because they merely linked the use of the abstract idea to a particular technological environment (i.e., “implementation via computers”) or were well-understood, routine, conventional activity recited at a high level of generality”). Therefore, the claims still recite an abstract idea of a certain method of organizing human activity.
Applicant further argues that the alleged abstract idea is integrated into a practical application because of an improvement to the technology. Applicant also argues the amendments do not link/apply the abstract idea to a particular technology and that specification provides sufficient support for “receiving system activity information…”. Examiner respectfully disagrees. The claims do not recite an improvement to the technology because the improvement is not to the functioning of the computer tool itself (See MPEP 2106.05(a)I: “It is important to note that in order for a method claim to improve computer functionality, the broadest reasonable interpretation of the claim must be limited to computer implementation. That is, a claim whose entire scope can be performed mentally, cannot be said to improve computer technology. Synopsys, Inc. v. Mentor Graphics Corp., 839 F.3d 1138, 120 USPQ2d 1473 (Fed. Cir. 2016) (a method of translating a logic circuit into a hardware component description of a logic circuit was found to be ineligible because the method did not employ a computer and a skilled artisan could perform all the steps mentally). Similarly, a claimed process covering embodiments that can be performed on a computer, as well as embodiments that can be practiced verbally or with a telephone, cannot improve computer technology. See RecogniCorp, LLC v. Nintendo Co., 855 F.3d 1322, 1328, 122 USPQ2d 1377, 1381 (Fed. Cir. 2017) (process for encoding/decoding facial data using image codes assigned to particular facial features held ineligible because the process did not require a computer)”). Instead, the additional elements (“memory”, “anode”, “processors”, “server device”, “neural networks (NNs)”, “image information module”, “scanner device”, “camera”, “printer”, “scannable code device”, and “non-transitory computer-readable medium”) are recited a high level and the abstract idea (determine, identify, actions, monitor, using, and execute) are being linked to the additional elements. Furthermore, the step of “receive system activity information corresponding to the technician station” is similar to performing clinical tests on individuals to obtain input for an equation, In re Grams, 888 F.2d 835, 839-40; 12 USPQ2d 1824, 1827-28 (Fed. Cir. 1989) and testing a system for a response, the response being used to determine system malfunction, In re Meyers, 688 F.2d 789, 794; 215 USPQ 193, 196-97 (CCPA 1982), which the courts have found to be insignificant extra-solution activity (See MPEP 2106.05(g)). Therefore, the abstract idea is not integrated into a practical application.
Applicant also argues the amendments to the claims amount to significantly more that the abstract idea. Examiner respectfully disagrees. As shown above, the additional elements are recited at a high level and individually or in combination they are being used to link to the abstract idea (see MPEP 2106.5(f) and MPEP 2106.05 A.Relevant Considerations for Evaluating Whether Additional Elements Amount to An Inventive Concept). Therefore, the claims do not amount to significantly more and the 35 U.S.C. 101 Rejection is maintained.
Regarding the 35 U.S.C. 102 Rejection, Applicant argues Cummings does not teach “digital copies are made from “sample slides” and that the amendments overcome the Rejection. Examiner partially disagrees. Although Cummings does not explicitly teach digital copies made from sample slides, Evans teaches at [0015] and [0074]: “gross examination and documentation of the selected tissue samples taken from resection specimens can be accomplished using multiple cameras, linked into the SIS”. However, the amendments to the claims are now rejected under 35 U.S.C. 103.
Regarding the previous 35 U.S.C. 103 Rejection, Applicant argues Cummings does not teach “biopsy sample”, “digital copies” of “sample slides”, or video recording of technician actions. Examiner respectfully disagrees. Cummings teaches samples [0111]: “An automated process that observes all of the available data sources may be implemented to determine the proper timing of samples for creation of histograms. A statistical algorithm is used to automatically determine the valid sample size for each implementation. The frequency of activity is observed and used to automatically calculate the minimum time segment required to produce a statistically valid sample”, but does not teach explicitly “biopsy” samples. Although Cummings does not teach “biopsy” sample, it is now remedied by Evans, which teaches the sample is a “biopsy” sample (Evans, FIG. 5, [0051]: “LDP may include a secure connection to an EMR 90 or lab information system (LIS) with access limited to the data required for recording the biopsy samples”, and [0076]: “FIG. 5 is a sample screen shot that may be used to provide graphical input for recording biopsy specimens taking using the system”). Evans also teaches a digital cope and sample slides.
Applicant also argue Evans does not teach “a case identifier to uniquely identify information associated with a biopsy sample”. Examiner respectfully disagrees. Evans teaches [0007]: “Biopsy specimens taken by a physician or assistant are placed on the top cassette of the spring-loaded magazine. An image is taken that includes a bar code or other identifier associated with the cassette and the actual specimen being stored in the cassette” and [0011]: “A biopsy may be associated with a unique identifier of a container securing the biopsy in response to receiving the confirmation”.
Applicant also argues the Cummings and Evans do not teach “wherein the scanning causes the camera to begin a video recording at a technician station”, “uniquely associating a video recording directed to a technician station, and using one or more neural networks to identify attributes and overarching patterns in the sample slides from the biopsy sample. Examiner respectfully disagrees. Evans teaches [0039]: “an application, program, operating system, kernel, or set of instructions that is configured to record patient information and data, store and communicate images, and manage the initial generation of an electronic record associated with the specimen obtained during the biopsy” and [0060]: “During step 232, the user and system may interact to measure and record the biopsy and a simple description of the specimen”. Therefore, the 35 U.S.C. 103 Rejection is maintained.
Conclusion
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RACHAEL SOJIN STONE whose telephone number is (571)272-8798. The examiner can normally be reached Monday-Friday 7 AM - 7 PM (EST).
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Peter Choi can be reached at (469) 295-9171. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/R.S.S./Examiner, Art Unit 3681
/PETER H CHOI/Supervisory Patent Examiner, Art Unit 3681
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