DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of the Claims
The claim set received 21 January 2026 has been entered into the application.
Claims 1, 3, 6-7, 9-10, 12-14, 16, 20, 22, and 24-26 are amended.
Claim 2 is cancelled.
Claims 1, 4-5, 14, 17-19, 20-21, and 25 are objected to.
Claim 27 is new.
1 and 3-27 are pending.
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in parent Application No. DE10 2020212189.3, filed 28 September 2020.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 30 January 2026 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
It is noted that NPL Citation No.: 1 is not considered because a translated copy of the reference was not provided.
Claim Objections
The objection of claims 1 and 14 provisioning step in the Office Action mailed 22 October 2025 is withdrawn in view of the amendments received 21 January 2026 because the claim was cancelled.
The objection of claims 4 and 17 establishing step in the Office Action mailed 22 October 2025 is withdrawn in view of the amendments received 21 January 2026 because the claim was cancelled.
The objection of claims 5 and 18-19 establishing step in the Office Action mailed 22 October 2025 is withdrawn in view of the amendments received 21 January 2026 because the claim was cancelled.
The objection of claims 5 and 18-19 establishing step in the Office Action mailed 22 October 2025 is withdrawn in view of the amendments received 21 January 2026 because the claim was cancelled.
The objection of claim 2 in the Office Action mailed 22 October 2025 is withdrawn in view of the amendments received 21 January 2026 because the claim was cancelled.
The objection of claim 25 in the Office Action mailed 22 October 2025 is withdrawn in view of the amendments received 21 January 2026..
Claim Rejections - 35 USC § 112
35 USC § 112(b)
The instant rejection is maintained for reason for record in the Office Action mailed 22 October 2025 and modified in view of the amendments filed 21 January 2026. It is noted the amendments received 21 January 2026 are necessitated by new ground(s) of rejection.
The rejection of claims 6-7, and 9 under 35 U.S.C § 112(b) in the Office Action mailed 22 October 2025 is withdrawn in view of the amendments received 21 January 2026.
The rejection of claim 13 under 35 U.S.C § 112(b) in the Office Action mailed 22 October 2025 is withdrawn in view of the amendments received 21 January 2026.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 5-7, 9, 13, and 18-21 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 5 and 18-19 recites “wherein the examination information includes the specification of second tissue slides, each suitable for each further histopathological staining.” Claim 5 is dependent on claim 4 which is dependent on claim 3 which is dependent on claim 1. Claim 18 is dependent on claim 17 which is dependent on claim 6 which is dependent on claim 1. Claim 19 is dependent on claim 3 which is dependent on claim 1. The limitation renders the claim indefinite because claims 18-19 are a substantial duplicate of claim 5. Additionally, it is not clear how the limitations of claims 18-19 are to further limit the limitations of claim 5 which is dependent on claim 4 which is dependent on claim 3 which is dependent on claim 1 which provides limitation for claim 5. It is not clear if claims 18-19 are providing the limitations for claim 5. It recommended to cancel claims 18-19 because claim 5 will have already been provided the limitations for claims 18-19 because claim 18 is dependent on claim 17 which is dependent on claim 1 while claim 19 is dependent on claim 3 which is encompasses the limitations of claim 1. Thus, the limitations of claims 18-19 appear to be substantial duplicates of claim 5.
Claim 20 and 21 recite “the histopathology dataset includes tissue sample information; and the establishing additionally occurs based on the tissue sample information.” Claim 20 is dependent on claim 7 which is dependent on claim 1. Claim 21 is dependent on claim 3 which is dependent on claim 1. The limitation renders the claim indefinite because claim 21 is a substantial duplicate of claim 20. Additionally, it is not clear how the limitations of claim 21 are to further limit the limitations of claim 20 which is dependent on claim 7 which provides limitation for claim 1. It is not clear if claim 21 is providing the limitations for claims 3. It recommended to cancel claim 21 because claim 20 will have already provided the limitations for claim 21 because claim 21 is dependent on claim 3 which is encompasses the limitations of claim 1. Thus, the limitations of claim 21 appear to be a substantial duplicate of claim 20.
Response to Arguments
Applicant's arguments filed 21 January 2026, have been fully considered but they are not persuasive. Therefore, the rejection is maintained.
The Applicant states the rejection is rendered moot by the present amendments [remarks, page 14].
In response, the amendments addressed some of the limitations, however, some of the rejections remained because the applicant did not address all the remaining rejected limitations.
Claim Rejections - 35 USC § 101
The instant rejection is maintained for reason for record in the Office Action mailed 22 October 2025 and modified in view of the amendments filed 21 January 2026. It is noted the amendments received 21 January 2026 are necessitated by new ground(s) of rejection.
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1 and 3-27 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter.
Following the flowchart of the MPEP 2106
Step I - Process, Machine, Manufacture or Composition
Claims 1, 3-13 and 17-27 are drawn to a computer-implemented method, so a process.
Claim 14 is drawn to a system, so a machine.
Claim 15 is drawn to a non-transitory computer program, so a manufacture.
Claims 16 are drawn to a non-transitory computer-readable memory medium, so a manufacture.
2A Prong One - Identification of an Abstract Idea
Claim 1 recites a computer-implemented method while claim 14 recites a system. Claims 1 and 14 recites similar limitations. Therefore, claims 1 and 14 are examined similarly.
Claims 1 and 14 recite:
establishing, using an analysis algorithm based on the histopathology dataset, examination information relating to a further pathological examination, the examination information including a specification creation of one or more second histopathology slide images, the one or more second histopathology slide images being different from the one or more first histopathology slides
This step can be performed in the human mind by organizing data to establish examination information for creating one or more histopathology slides and is therefore an abstract idea. Here, the limitation “…examining information including specification for creating one or more second histopathology slides…” is interpreted as instructions (i.e., data for creating a slide) created by a computer algorithm (i.e., data or data instructions). Thus, the creation limitations are not interpreted as physical step of creating slides but as data. Furthermore, under broadest reasonable interpretation (BRI), the limitation “establishing” is interpreted as analysis steps that can be performed in the human mind. This step also recites a generic “analysis algorithm” based on the histopathology dataset which reads on performing mathematical computations using an analysis algorithm which reads on abstract ideas/mathematical concepts. See MPEP 2106.04(a)(1)(C).
provisioning the examination information established.
This step can be performed in the human mind by organizing information (i.e., examination information) to provision the information and is therefore an abstract idea.
Claims 3-6, 8-10, 12, 17-21, and 23-26 are further drawn to limitations that describe the abstract ideas of claim 1 and are therefore also abstract ideas.
2A Prong Two: Consideration of Practical Application
Claims 1 and 14 do not recite any additional element which integrates the recited judicial exception into a practical application.
Here, in the instant case, the claims merely set forth a method of data analysis for supplying/collecting and subsequently provisioning established information. As such, practicing the claims merely results using an algorithm to establish examination information that is subsequently provisioned. Such a result only produces information and does not provide for a practical application in the physical realm of physical things and acts, i.e., the claims do not utilize the data generated by the judicial exception to affect any type of change. Therefore, the claims do not utilize the provisioned histopathology datasets, established examination information, and the abstract ideas to construct a practical application such as treating a subject, transformation of matter, and/or improving upon an existing technology.
Here, under broadest reasonable interpretation (BRI), claim 27 is interpreted as merely taking a photograph of a slide. Furthermore, claim 27 does not integrate the judicial exception into a practical application because the recitation of claimed limitations “…creating the one or more second histopathology slide images” attempt to cover any solution for creating slide images with no restriction on how the result (i.e., creating the slide image) is accomplished and no description of the mechanism for accomplishing the result. As such, this type of recitation is equivalent to the words "apply it". See MPEP 2106.05(f)(1).
This judicial exception is not integrated into a practical application because the claims do not meet any of the following criteria:
An additional element reflects an improvement in the functioning of a computer, or an improvement to other technology or technical field;
an additional element that applies or uses a judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition;
an additional element implements a judicial exception with, or uses a judicial exception in conjunction with, a particular machine or manufacture that is integral to the claim;
an additional element effects a transformation or reduction of a particular article to a different state or thing; and
an additional element applies or uses the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception.
2B: Consideration of Additional Elements and Significantly More
The claimed method also recites "additional elements" that are not limitations drawn to an abstract idea.
The recited additional element of using computer processes, components, and equipment of claims 1, 11, and 13-16 does not add significantly more than the recited judicial exception because using computer processes and computer components and equipment (i.e., computer-readable memory medium) to store, process, and analyze the abstract idea is well-known and conventional. See MPEP 2106.05(b) and 2106.05(d). To provide evidence of conventionality of using computer processes and computer equipment, Park et al. (Park) reviews using different system used for processing histopathology slides [page 84 fig 1], using interfaces [page 88 right col], and using an anatomic pathology laboratory information system [page 92 fig 5] (Adv Anat Pathol. 2012 Mar;19(2):81-96).
The recited additional element of provisioning a histopathology dataset of claims 1 and 14 provisioning step does not add significantly more than the recited judicial exception because provisioning a histopathology data set (i.e., collecting/supplying data) that is subsequently analyzed by the abstract ideas is well-known and conventional extra-solution activity. See 2106.05(g). To provide evidence of conventionality of provisioning histopathology samples, Potts et al. (Potts) discloses method using connective tissue sections using FACTS analysis for identifying regions of interests [abstract]. Potts discloses processing tissue samples using slides [figures 1-2]. Potts discloses methods for processing (i.e., provisioning) tissue samples from paraffin block and digitally processing the images (Potts, claim 1--5) (US Patent Pub No.: US 2012/0076390, Patent Pub Date: 29 March 2012). To provide further evidence of conventionality of provisioning histopathology samples, Leavitt et al. (Leavitt) discloses method for processing (i.e., provisioning) histopathology slides using slides, labeling methods, and performing analysis of slides [Leavitt, claims 1-2, 9, and 15] (US Patent Pub No.: US 2020/0139361, Patent Pub Date: 07 May 2020).
The recited additional element of using computer components and equipment of claims 11 and 13-16 does not add significantly more than the recited judicial exception because using a computer interface(s) to output and display data is well-known and conventional. See MPEP 2106.05(b) and 2106.05(d). To provide evidence of conventionality of using computer processes and computer equipment, Park et al. (Park) reviews using different system used for processing histopathology slides [page 84 fig 1], using interfaces [page 88 right col], and using an anatomic pathology laboratory information system [page 92 fig 5].
The recited additional element of data gathering of claims 7 and 22 does not add significantly more than the recited judicial exception because using retrieving data (i.e., medical data) that is subsequently evaluated by abstract idea is well-known and conventional extra-solution activity. See MPEP 2106.05(g).
The recited additional element of data outputting of claim 11 does not add significantly more than the recited judicial exception because using a computer interface for outputting and/or displaying data is well-known and conventional extra-solution activity. See MPEP 2106.05(g).
The recited additional element of data inputting of claim 13 does not add significantly more than the recited judicial exception because using a computer interface for outputting and/or displaying data is well-known and conventional extra-solution activity. See MPEP 2106.05(g). To provide evidence of conventionality of using computer processes and computer equipment, Park et al. (Park) reviews using interfaces [page 88 right col], and using an anatomic pathology laboratory information system [page 92 fig 5].
The recited additional element of data gathering of claims 12-14 and 26 does not add significantly more than the recited judicial exception because using receiving data that is subsequently evaluated by abstract idea is well-known and conventional extra-solution activity. See MPEP 2106.05(g).
The recited additional element of creating slide images of claim 27 does not add significantly more than the recited judicial exception because using a creating images form slides is deemed is routine, well-known, and conventional. See MPEP 2106.05(b) and 2106.05(d). To provide evidence of conventionality of creating images from slides, Thagaard et al. (Thagaard) discloses a workflow using tissue sample sectioning, creating a slide, staining, and digitizing for shole slide imaging [figure 4] (US Patent Pub US 2012/0232930 Pub Date 13 Sept 2012).
In conclusion, and when viewed as a whole, these additional claim element(s) do not provide meaningful limitation(s) to transform the abstract idea recited in the instantly presented claims into a patent eligible application of the abstract idea such that the claim(s) amounts to significantly more than the abstract idea itself. Therefore, the claim(s) are rejected under 35 U.S.C. 101 as being directed to non-statutory subject matter.
Response to Arguments
Applicant's arguments filed 21 January 2026, have been fully considered but they are not persuasive. Therefore, the rejection is maintained. It is noted the amendments received 21 January 2026 are necessitated by new ground(s) of rejection.
The Applicant traverses the rejection under 101. The Applicant disagrees the claims do not integrate the recited judicial exception into a practical application. The Applicant points to Step 2A Prong of the 101 analyses and MPEP 2106.04(d)(l) and 2106.05(a) for guidance. The Applicant points to the specification paragraphs [0008-0009, 0076] [remarks, pages 11-13]. The Applicant states claim 1 puts valuable information at the user's disposal for planning the further pathological appraisal and to underpin possible medical diagnoses or to invalidate them and enables not only the further examination of the patient to be designed in a more targeted manner, which saves time and money, but also enables the hit rate for the pathological appraisal to be increased allowing therapy decisions to be taken earlier, which can have a positive effect on the success of therapy. The Applicant states claim 1 provides an improvement to technology in automated medical image processing and diagnosis [remarks, page 13].
In response, and as noted in the 101 analyses above, the claims do not integrate the judicial exception into a practical application because the claims recite provisioning histopathology data, establishing data (i.e., instructions/specifications for creating slides), and provisioning information (i.e., organizing data) which reads on abstract ideas. Moreover, and as noted in Step 2A Prong II of the 101 analyses above, claims 1 and 14 do not contain any additional elements that integrate the judicial exception into a practical application such that to provide an improvement to technology. Provisioning data (i.e., established examination information), thus, reads on abstract ideas (i.e., gathering/organizing data). Furthermore, the recitation of “creating one or more slides…” of claim 27 attempts to cover any solution for creating slide images with no restriction on how the result (i.e., creating the slide image) is accomplished and no description of the mechanism for accomplishing (i.e., creating) the result which is equivalent to the words "apply it". See MPEP 2106.05(f)(1). Thus, the claimed steps do not integrate the abstract ideas with the judicial exception to provide an improvement. Therefore, claims are not patent eligible under 35 U.S.C § 101.
Claim Rejections - 35 USC § 102
The rejection of claims 1, 10, 12, 14-16, 22 and 25-26 under 35 U.S.C § 102 in the Office Action mailed 22 October 2025 is withdrawn in view of the amendments received 21 January 2026.
Claim Rejections - 35 USC § 103
The instant rejection is maintained for reason for record in the Office Action mailed 22 October 2025 and modified in view of the amendments filed 21 January 2026. It is noted the amendments received 21 January 2026 are necessitated by new ground(s) of rejection.
The rejection of claim(s) 2-5 and 17-19 under 35 U.S.C. §103(a) as being unpatentable over Tosun, as applied to claims1, 6, 10-12, 13-16, 20-21, and 25-26, and in view of Thagaard in the Office Action mailed 22 October 2025 is withdrawn in view of the amendments received 21 January 2026.
The rejection of claim(s) 7-8 and 22-23 under 35 U.S.C. §103(a) as being unpatentable over Tosun, as applied to claims 1, 6, 10-12, 13-16, 20-21, and 25-26 and in view of Schmidt et al. (WO 2018/229052 Int. Pub Date 18 Dec 2018) in view of Thagaard in the Office Action mailed 22 October 2025 is withdrawn in view of the amendments received 21 January 2026.
The rejection of claim(s) 9 and 24 under 35 U.S.C. §103(a) as being unpatentable over Tosun, as applied to claims 1, 6, 10-12, 13-16, 20-21, and 25-26, and in view of Hegde (NPJ digital medicine, 2019-06) in view of Thagaard in the Office Action mailed 22 October 2025 is withdrawn in view of the amendments received 21 January 2026.
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1, 3-6, 10-21, and 25-27 are rejected under 35 U.S.C. §103(a) as being unpatentable over Tosun et al. (US Patent Pub. US 2020/0294231 Date: 17 Sept 2020) in view of Thagaard et al. (US Patent Pub US 2012/0232930 Pub Date 13 Sept 2012).
Claim 1 recites a computer-implemented method while claim 14 recites a system. Claims 1 and 14 recites similar limitations. Therefore, claims 1 and 14 are examined similarly.
Claims 1 and 14 recite provisioning a histopathology dataset including one or more first histopathology slide images, each first histopathology slide image of the first histopathology slide images showing a first tissue slide prepared from a tissue sample of a patient and stained with a first histopathological staining
Claims 1 and 14 recite establishing, using an analysis algorithm based on the histopathology dataset, examination information relating to a further pathological examination, the examination information including a specification creation of one or more second histopathology slide images, the one or more second histopathology slide images being different from the one or more first histopathology slides.
Claims 1 and 14 recite provisioning the examination information established.
Tosun et al. (Tosun) discloses a method for distributing cases among a group of pathologists, the method comprising. Tosun teaches for each one of a plurality of cases, processing a corresponding whole slide image (WSI) of a tissue, the processing of the WSI comprising: identifying one or more regions of interest (ROI’s) in the WSI, each ROI having designated thereto a respective diagnostic label indicating a condition of a tissue in the ROI. Tosun teaches for each ROI, computing a respective confidence score for the respective designation, computing for the WSI: (i) a severity score based on the respective diagnostic labels designated to the one or more RO is in the WSI. Tosun teaches (ii) a confidence level based on the respective confidence scores for the one or more Rois. Tosun teaches storing as explanatory information, the severity score, the confidence level, and the respective confidence scores. Tosun teaches if the severity score is at or above a specified threshold severity score, transmitting the WSI to a rush pathologist in the group of pathologists. Tosun teaches otherwise, if the confidence level is at or below a specified threshold confidence level. Tosun teaches transmitting the WSI to a subspecialist in the group of pathologists. Tosun teaches, otherwise, transmitting the case to a generalist pathologist in the group of pathologists [claim 18], as in instant claim 1 provisioning a histopathology dataset including one or more first histopathology slide images step and instant claim 14 an interface embodied to receive a histopathology dataset step.
Tosun teaches using HistoMapr that has a database to store, manage, and retrieve the ground truth label around 1,000 ROI’s [Spec page 9 0113 right col]. Tosun teaches a pathologist reviewing data [Figure 12]. Tosun teaches key finding using HistoMapr interface showing key findings [figures 6 and 8-10], as in instant claims 1 and 14 provisioning the examination information established.
Dependent claim(s): 6, 10-13, 15-16, 20-21, and 25-26
Tosun teaches designating the region of interest (ROI) with a label indicating tissue condition associated with the class and with the tissue [claim 1]. Tosun teaches displaying a portion of the WSI, designated label, a user interface, additional user interface elements to provide feedback [claim 1]. Tosun teaches the tissues comprise breast tissue [claim 2], lung tissue [claim 3], and brain tissue [claim 4], as in instant claims 6 and 20-21. Therefore, it would be obvious that establishing occurs based on tissue sample.
Tosun teaches using a classifier trained to classify an image using feature types [claim 1], as in instant claims 10 and 25.
Tosun teaches a pathologist reviewing histopathology slide data on an explainable interface [figure 1A]. Tosun teaches outputting information to the user of HistoMapr [figures 1C, 2B, 5-6, 9-10 and 12], as in instant claim 11.
Tosun teaches using the software HistoMapr. Tosun teaches decision and explanation interface with respect to looking at histopathology slides using the analysis of HistoMapr figures 12-15, 17-20], as in instant claims 12 and 26. Here, the limitations of Tosun make obvious pathologists and/or interface users receiving feedback, appraisals, and/or specification (i.e., acknowledgments) and changing the examination information based on the data retrieve or reviewed using HistoMapr. It is further obvious to re-analyze (i.e., provision the acknowledgment to the analysis algorithm for adapting (i.e., re-evaluating or further evaluating) examination information using the analysis algorithm data based on the pathologists and/or user interface analysis or results with respect to regions of interests (ROI’s) of whole slide image (WSI).
Tosun teaches using the software HistoMapr. Tosun teaches decision and explanation interface with respect to looking at histopathology slides using the analysis of HistoMapr figures 12-15, 17-20]. Tosun teaches that results such as forward to specialists, needs attention, urgent finding [fig 19], as in instant claim 13. Here, the limitations of Tosun make obvious receiving a user appraisal entry from a pathologists and/or interface users with respect to further pathological examination because HistoMapr questions “why not something else” [fig 12], supplies diagnostic categories [fig 13], and identifies case attributes [fig 18]. It would be further obvious to establish or re-establish examination information based on appraisals, recommendations, or findings of a user (i.e., pathologist or sub specialist).
Tosun teaches using the program HistoMapr [abstract]. Tosun teaches storing explanatory information [claims 1, 11, 13, 22 and 28]. Tosun teaches “The computer program(s) can execute on one or more programmable processing elements or machines, and can be stored on one or more storage medium readable by the processor (including volatile and non-volatile memory and/or storage elements), one or more input devices, and/or one or more output devices.” [Spec page 22 right col 0248], as in instant claim 15.
Tosun teaches using the program HistoMapr [abstract]. Tosun teaches storing explanatory information [claims 1, 11, 13, 22 and 28]. Tosun teaches “The computer program(s) can execute on one or more programmable processing elements or machines, and can be stored on one or more storage medium readable by the processor (including volatile and non-volatile memory and/or storage elements), one or more input devices, and/or one or more output devices.” [Spec page 22 right col 0248]. Tosun teaches “the disclosed methods, devices, and systems can be deployed on convenient processor platforms, including network servers, personal and portable computers, and/or other processing platforms. Other platforms can be contemplated as processing capabilities improve, including personal digital assistants, computerized watches, cellular phones and/or other portable devices” [page 22 Spec 0247]. Tosun teaches “device(s) or computer systems that integrate with the processor(s)/processing element(s) can include, for example, a personal computer(s), workstation (e.g., Dell, HP), personal digital assistant (PDA), handheld device such as cellular telephone, laptop, handheld, or another device capable of being integrated with a processor(s) that can operate as provided herein.” [page 22 Spec 0251], as in instant claim 16.
Tosun does not teach claims 1 and 14 establishing step. Tosun does not teach claims 3-5, 17-19, and 27.
It is noted Tosun [fig 8] and Thagaard [fig 3-4] both disclose systems for processing their methods (i.e., system of claim 14).
Thagaard discloses methods for using tissue sample for creating slides [Thagaard, fig 1]. Thagaard discloses a workflow for training a deep learning model based using histopathological data from adjacent tissue samples stained using different method (i.e., provisioned histopathology dataset) [Thagaard, fig 2]. Thagaard discloses the tissue samples come from adjacent sections [Thagaard, page 20 14. lines 20-24 and 16. Lines 29-34]. Thagaard discloses using different staining methods/protocols for the different samples [Thagaard, page 18 1., lines 6-9]. Thagaard also discloses using machine learning method (i.e., neural network) for analyzing histopathology data for obtaining histopathological information [Thagaard, page 19 lines 18-35].
Additionally, Tosun discloses using a classifier trained to classify an image using features of the plurality of feature types into one of a plurality of classes of tissue conditions. Tosun teaches the classifier can be a neural network, support vector machine, or random forest [Tosun, claim 16]. Tosun discloses whole slide image (WSI) are viewed/examined by a pathologist are ordered. Tosun discloses HistoMapr analyzes each WSI is a set of WSI. Tosun discloses that WSI may then be ordered based on the number of regions of interest (ROIs), number of identified conditions, severity of the ROIs (which can be the maximum, average, weighted average, etc., severity across all ROIs in a WSI), confidence scores of the ROIs (which can be the maximum, average, weighted average, etc., confidence scores across all ROIs in a WSI), or a combination of two or more of these factors (i.e., establishing examination information and provisioning the examination information) [Tosun, page 14, right col para 0156], as in instant claims 1 and 14 establishing, using an analysis algorithm based on the histopathology dataset, examination information relating to a further pathological examination, the examination information including a specification for creation of one or more second histopathology slide images, the one or more second histopathology slide images being different from the one or more first histopathology slides. Thus, based on the above teachings of Tosun and Thagaard, it is obvious that examination information can be established based on slide image data of two different samples stained differently (i.e., data generated with an analysis algorithm) and can be subsequently provisioned.
Dependent claim(s): 3-5, 17-19, and 27
Thagaard et al. (Thagaard) teach a method for labeling histopathological images by providing a first image of a first section of a specimen with the first section being stained. Thagaard discloses providing a second image of a second section of the specimen, the first and second sections being adjacent sections of the specimen (i.e., different sample), wherein the second section has been stained using a second staining protocol different from the first staining protocol [claim 1]. Thagaard discloses tissue samples from adjacent tissue section using different IHC staining protocols [Fig 3]. Additionally, Tosun discloses “the WSI’s to be viewed/examined by a pathologist are ordered. To this end, an embodiment of HistoMapr analyzes each WSI, as described above, in a set of WSI’s. The WSI’s may then be ordered based on the number of RO Is, number of identified conditions, severity of the ROI’s (which can be the maximum, average, weighted average, etc., severity across all ROI’s in a WSI), confidence scores of the ROI’s (which can be the maximum, average, weighted average, etc., confidence scores across all ROI’s in a WSI), or a combination of two or more of these factors [Spec page 14 right col. 0156], as in instant claims 3-5 and 17-19.
Tosun discloses HistoMapr analyzes each WSI is a set of WSI. Tosun discloses that WSI may then be ordered based on the number of regions of interest (ROIs), number of identified conditions, severity of the ROIs (which can be the maximum, average, weighted average, etc., severity across all ROIs in a WSI), confidence scores of the ROIs (which can be the maximum, average, weighted average, etc., confidence scores across all ROIs in a WSI), or a combination of two or more of these factors [Tosun, page 14, right col para 0156]. Thagaard discloses workflow for creating slides from adjacent tissue samples and processing the data using digitalization methods for WSI imaging [Thagaard, figs 1-4], as in instant claim 27. Here, it would be obvious to utilize a workflow such as the diagrams of figure 2-4 of Thagaard for creating new slides for pathologists in order to reevaluate and/or a patient’s whether a patient has tissue and/or cellular abnormalities.
It would be obvious to one of ordinary skill in the art by the effective filing date of the clamed invention to modify Tosun in view of Thagaard because Thagaard discloses preparing and analyzing first and second stained histopathology images. One of ordinary skill in the art would be motivated to combine Tosun in view of Thagaard because Thagaard discloses analyzing different histopathological image slides from adjacent sample using different staining protocols [claims 1-2] which teaches using different image slides (i.e., second image slide) using different samples such as adjacent sections of a sample, for example [claims 1-2]. Here, there is a reasonable expectation of success combining Tosun with Thagaard because Thagaard discloses methods for obtaining different slide image data using multiple slides, using different samples, and using different staining protocols which could be utilized to construct a method or system for using/combining image slide data from more than one image slide(s) for provisioning histopathology datasets and provisioning the examination information established. Furthermore, there is a further reasonable expectation of success combining Tosun in view of Thagaard because although Thagaard discloses their method depends on staining of two different and adjacent sections of a sample and using different staining protocols Thagaard discloses their methods were able to efficiently train their deep learning model [Thagaard, page 3 lines 18-20] which would create an obvious and efficient method using machine learning elements for processing/provisioning stained WSI histopathology datasets for establishing examination information of different samples stained differently. Thus, combining the teachings of ordering new slides (i.e., examination information including specification creating new slides) of Tosun in view of creating different histopathological slides of Thagaard would yield a predictable computer implemented method and a system using that different histopathological slide data for provisioning, establishing examination information for creating or ordering new WSI based on ROI analysis, and provisioning the information for subsequent pathological WSI examination.
Claim(s) 7-8 and 22-23 are rejected under 35 U.S.C. §103(a) as being unpatentable over Tosun in view of Thagaard, as applied to claims1, 3-6, 10-21, and 25-27, and 25-26 and in further view of Schmidt et al. (WO 2018/229052 Int. Pub Date 18 Dec 2018).
Tosun in view of Thagaard discloses claims 1, 3-6, 10-21, and 25-27.
Tosun in view of Thagaard disclose methods and a system for analyzing histopathology slides using computer algorithms, performing provisioning protocols to obtain different samples stained differently, and provisioning examination information.
Tosun in view Thagaard does not teach claims 7-8 and 22-23.
Schmidt et al. (Schmidt) teach using data regarding clinical action from magnetic resonance (MR) tomography [claim 3], using clinical action data refines an earlier diagnosis [claim 4], using clinical action data refines an earlier diagnosis [claim 5],generating a protocol that indicates the decision and the potential next clinical actions [claim 17], and receiving a decision as to which set of potential next clinical action are to be applied to the patient [claim 24]. Schmidt teaches patient data includes the name and age of the patient and a short summary of the patient's diagnosis [Spec page 5 0057 left col.]. Schmidt teaches clicking on the icon reveals the results of the patient’s blood tests and mammography as well as tissue-based data from pathology and gene expression data [Spec page 5 0058 right col]. Schmidt teaches a conclusion is either a patient diagnosis, such as breast cancer, or the categorization of a finding in a medical image. Examples of categorizations of findings in medical images include a BI-RADS category for mammography images or an Elston-Ellis grading of H&E-stained breast cancer tissue sections [Spec page 5 0058 left col.]. Schmidt teaches a diagnostic step could be to perform an oral "examination' in which the physician finds out more details about the patient’s history [Spec page 5 0059 left col.], as in claims 7-8 and 22-23. Here, it is obvious that medical data assigned to a histopathology dataset would encompasses patient data such as personal data, laboratory data results recommendation, radiological results and recommendation, and histopathological data and results.
It would be obvious to one of ordinary skill in the art by the effective filing date of the claimed invention to modify Tosun in view of Thagaard and in further view of Schmidt because Schmidt discloses a clinical support system that receives the health record of the patient and determines which clinical actions were already applied on the patient [abstract]. One of ordinary skill in the art would be motivated to combine Tosun in view of Thagaard and in further view of Schmidt because Schmidt teaches of Schmidt because Schmidt discloses comparing different health record data of different patients to determine clinical actions performed on similar patients. Here, combining the medical data of Schmidt with the HistoMapr system of Tosun and slide creation methods of Thagaard would yield a predictable method that can use medical data from patient electronic health records and receive acknowledgments regarding examination information of histopathological samples for finding and diagnosing histopathological pathologies based on the results and evidence from different patients with similar pathologies.
Claim(s) 9 and 24 are rejected under 35 U.S.C. §103(a) as being unpatentable over Tosun in view of Thagaard, as applied to claims1, 3-6, 10-21, and 25-27 , and in further view of Hegde et al. (NPJ digital medicine, 2019-06).
Tosun in view of Thagaard disclose claims 1, 3-6, 10-21, and 25-27.
Tosun in view of Thagaard disclose methods and a system for analyzing histopathology slides using computer algorithms, performing provisioning protocols to obtain different samples stained differently, and provisioning examination information (i.e., WSI data).
Tosun in view of Thagaard does not teach claims 9 and 24.
Hegde et al. (Hegde) teaches using Similar Medical Images Like Yours (SMILY) and assessing SMILY’s ability to retrieve search results in two ways: using pathologist provide annotations and evaluating the quality of SMILY search results [abstract]. Hegde teaches “an overview of Similar Medical Images Like Yours (SMILY). First, a database of image patches and a numerical characterization of each patch’s image contents (termed the embedding) is created. SMILY uses a convolutional neural network to compute this embedding (schematic used for illustration purposes only, see Methods for architecture descriptions). Next, when a query image is selected, SMILY computes the embedding of that query image and compares the embedding with those in the database in a computationally efficient manner. Finally, SMILY returns the k most similar patches, where k is customizable.” [page 2 figure 1]. Hegde teaches summary of data which can be viewed in the SMILY user interface. The data and/or datasets include: dataset, organ site, number of slides, patches, and query sets [page 3 table 1 figure 3]. Hegde teaches overall match score of multi-aspect similarity evaluation [page 6 table 3]. Hegde teaches similarity rating from pathologist [page 6 figure 5], as in claims 9 and 24.
It would be obvious to one of ordinary skill in the art by the effective filing date of the claimed invention to modify Tosun in view Thagaard and in further view of Hegde because Hegde teaches using histopathology database that encompasses histopathology dataset and using the datasets for performing similar image search of histopathology sample/images. One of ordinary skill in the art would be motivated to combine Tosun in view Thagaard and in further view of Hegde because Hegde teaches using histopathology dataset for determining similarities between histopathology images for suspected pathologies. One of ordinary skill in the art would expect a reasonable success in combining/substituting the datasets of Hegde in the HistoMapr system of Tosun and the protocol for creating slides using different samples and different sample staining methods of Thagaard in order to yield a predictable system for selecting similar images/data for performing pathological examinations.
Response to Arguments
Applicant's arguments filed 21 January 2026, have been fully considered but they are not persuasive. Therefore, the rejection is maintained. It is noted the amendments received 21 January 2026 are necessitated by new ground(s) of rejection. It is noted the rejection is modified and restructures according the amendments filed 21 January 2026. It is further noted that
The Applicant states Thagaard fails to disclose the limitations of claim 2 (now amended into claims 1 and 14) "wherein the examination information includes a specification for creation of one or more second histopathology slide images, the one or more second histopathology slide images being different from the one or more first histopathology slide images.” [remarks, page 15]. The Applicant points to claim 1 and fig 3 of Thagaard for clarification. The Applicant states “Thagaard discloses first and second images of a specimen that have previously been created (e.g., stained). Thagaard discloses a method to label the second image according to histopathological information of the first image. However, Thagaard is completely silent on a specification for creation of the second image.” [remarks, pages 14-16]. The Applicant points the disclosure of Tosun paragraphs [0153-0154 and 0156] for clarification. The Applicant states Tosun and Thagaard do not teach the amended claimed step “establishing, using an analysis algorithm based on the histopathology dataset, examination information relating to a further pathological examination, the examination information including a specification creation of one or more second histopathology slide images, the one or more second histopathology slide images being different from the one or more first histopathology slides.” [remarks, page 16-17].
In response, it is noted above, Tosun in view of Thagaard, disclose the limitations of the amended establishing step of claims 1 and 14. As further noted above, Thagaard discloses a method using different tissue samples and performing different staining processes on the different tissue sample and using machine learning elements for analyzing the histopathological data of a first and second sample. It is noted that Thagaard discloses [page 20 14 lines 20-24, page 16 lines 29-34] specific specifications for the first and second samples (i.e., sample thinner than 1µm, adjacent sections at a distance of less than 50µm). To add, Tosun discloses new slide(s) can be ordered based on subsequent analysis of WSI slides. Additionally, Tosun discloses that slides can be ordered based on the number of regions of interest (ROIs), number of identified conditions (i.e., established information), for example, which renders a specification (i.e., orders, instructions, order specification (i.e., type of staining, distance of sample from one another)) for creating on or more slides based on data (i.e., established information) obvious. Thus, it would be obvious to utilize the methods of Thagaard for creating slides (i.e., different sample using different staining) for ordered or newly ordered histopathological analysis of Tosun.
Double Patenting
The rejection of claims 1, 10, 12, 14-16, 22 and 25-26 under provisional double patenting in the Office Action mailed 22 October 2025 is withdrawn in view of the amendments received 21 January 2026.
Conclusion
Claims 1 and 3-27 are rejected.
No claims are allowed.
Finality
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/J.C.P./ Examiner, Art Unit 1687
/Anna Skibinsky/
Primary Examiner, AU 1635
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