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 Claims
Claims 1-20 are pending.
Response to Arguments
Applicant’s arguments, see p.2-9, filed 07/30/2026, with respect to the rejections of Claims 1-20 under 35 U.S.C. 101 have been fully considered and are persuasive. Therefore, the rejections of Claims 1-20 under this section of the Rules has been withdrawn.
Applicant’s arguments, see p. 2, filed 07/30/2026, with respect to the rejections of Claims 1 and 11 on the grounds of nonstatutory double patenting as being unpatentable over Claims 1 and 11 of its parent U.S. Patent No. 12,023,817 have been fully considered and are persuasive. The terminal disclaimer filed on 07/30/2026 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of U.S. Patent No. 12,023,817 has been reviewed and is accepted. The terminal disclaimer has been recorded. Therefore, the rejections of Claims 1 and 11 under this section of the Rules has been withdrawn.
Applicant’s arguments, see p.10-15, filed 07/30/2026, with respect to the rejections of Claims 1-20 under 35 U.S.C. 103 have been fully considered but are moot because Applicant’s amendments of the independent claims has altered the scope of the claims, and therefore, necessitated new grounds of rejection which are presented below. Accordingly, THIS ACTION IS MADE FINAL.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-4, 7, 10, 11-14, 17, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Madabhushi et al. (US 20200242756 A1) in view of Barnes et al. (US 20170328817 A1) and Torre-Bueno (US 20040009098 A1).
Regarding Claim 1, Madabhushi teaches "A system for a slide marking technique for target tissue extraction and downstream application, the system comprising: at least a marking device, wherein the at least a marking device is configured to: image one or more surfaces of a sample associated with a stained slide"; (Madabhushi, Claim 20, teaches a system which accesses a digitized hematoxylin and eosin stained whole slide image of a region of tissue demonstrating ER+ breast cancer where the region of tissue includes a tumor region, i.e., image one or more surfaces of a sample associated with a stained slide by accessing the image of tissue in the stained whole slide image);
"and mark a region of interest associated with the sample"; (Madabhushi, Claim 20, teaches generating a segmented tumor region by segmenting the tumor region represented in the digitized H&E stained whole slide image and defining a plurality of tumor patches based on the segmented tumor region, i.e., marking a region of interest associated with the sample being the tumor region marked via segmentation).
However, Madabhushi does not explicitly teach "at least a computing device comprising at least a processor and a memory, the computing device configured to: receive the images of the one or more surfaces of the sample; receive a stained slide image of the sample; determine a geometric registration of the images of the one or more surfaces of the sample to the stained slide image; determine the region of interest associated with the sample as a function of the geometric registration; generate an annotation mask corresponding to the region of interest; and provide, to the marking device, mask data defining the region of interest based on the annotation mask; wherein the marking device interprets the mask data to physically trace the region of interest on the sample".
In an analogous field of endeavor, Barnes teaches "at least a computing device comprising at least a processor and a memory, the computing device configured to: receive the images of the one or more surfaces of the sample"; (Barnes, Paras. 4 and 7, teaches a system including a processor and memory wherein the tissue slide to be dissected is loaded on the stage and live image captured for tissue extraction, i.e., receive images of the one or more surfaces of the sample);
"receive a stained slide image of the sample"; (Barnes, Para. 4, teaches a H&E slide is loaded on to the stage and imaged for the user to outline the annotations, i.e., receive a stained slide image of the sample);
"determine a geometric registration of the images of the one or more surfaces of the sample to the stained slide image"; (Barnes, Para. 21, teaches the registration methods have the generic ability to register stained or unstained slides wherein any other registration method may be used so long as it provides automated mapping of annotations across images having different stains, including the capability to register stained to unstained tissue slides, in a manner that enables precise milling of areas of interest based on annotated reference slides, or enables registration of stained and unstained slides, i.e., determine geometric registration of the images of the one or more surfaces of the sample to the stained slide image);
"determine the region of interest associated with the sample as a function of the geometric registration"; (Barnes, Paras. 25-26, teaches transferring or mapping the annotations from one or more reference images to an image of a tissue section subject to dissection using the registration and mapping module wherein annotations depict clinically relevant regions, i.e., determine regions of interest associated with the sample as a function of the registration being the transferring or mapping of annotations using the registration module);
"generate an annotation mask corresponding to the region of interest"; (Barnes, Paras. 26 and 28, teaches annotations may be generated using image analysis algorithms for detecting and/or segmenting objects or areas of interest within the reference image wherein annotation data may include labelled region masks and contours of the annotations including the region or areas of interest, i.e., generate an annotation mask that corresponds to a region or area of interest);
"and provide, to the marking device, mask data defining the region of interest based on the annotation mask"; (Barnes, Paras. 28-30, teaches the annotation importing module receives the reference images and annotations and prepares them to be registered and/or mapped to a live image of a tissue slide then mapping the annotations from each reference slide to the live image of the slide wherein the milling module performs dissection on the milling slides by following the annotations mapped from the reference image to the live image of the slide, i.e., the annotation mask data that defines the region of interest based on the mask being the annotation contours of the region of interest are provided to the marking device being the milling module).
It would have been obvious to one having ordinary skill in the art before the effective filing date to modify the invention of Madabhushi by including the receiving of images of samples and stained slide images of samples and determining a registration of the images and a region of interest associated with the registration for generating an annotation mask of the region to provide it to a marking device taught by Barnes. One of ordinary skill in the art would be motivated to combine the references since it improves the ability to transfer annotations (Barnes, Para. 21, teaches the motivation of combination to be to improve the ability to transfer annotations from reference slides to milling annotations for a milling slide).
However, the combination of references of Madabhushi in view of Barnes does not explicitly teach "wherein the marking device interprets the mask data to physically trace the region of interest on the sample".
In an analogous field of endeavor, Torre-Bueno teaches "wherein the marking device interprets the mask data to physically trace the region of interest on the sample"; (Torre-Bueno, Paras. 59, 69, and 105, teaches a tracer comprising a hydrophobic medium wherein the tracer is capable of contacting the slide and tracing a line around a biological sample on the slide and wherein a camera is positioned to acquire an image of the slide on a stage in which the image can be processed to identify a border of a tissue sample on the slide which is then used to draw a hydrophobic outline around the tissue sample and wherein the image can be used to direct a tracer to outline the specimens on the slide, i.e., marking device being the tracer interprets the mask data being the processed image data to identify a border of a tissue sample to physically trace the region of interest on the sample).
It would have been obvious to one having ordinary skill in the art before the effective filing date to modify the invention of Madabhushi and Barnes by including the marking device interpreting mask image data to physically trace a region of interest on the sample taught by Torre-Bueno. One of ordinary skill in the art would be motivated to combine the references since it improves reliability and lowers costs (Torre-Bueno, Para. 129, teaches the motivation of combination to be to lower system cost and improve reliability for focusing).
Thus, the claimed subject matter would have been obvious to a person having ordinary skill in the art before the effective filing date.
Regarding Claim 2, the combination of references of Madabhushi in view of Barnes and Torre-Bueno teaches "The system of claim 1, wherein the mask data comprises one or more instructions for guiding movement of the marking device to physically trace the region of interest on the sample"; (Torre-Bueno, Paras. 43, 59, 69, and 105, teaches the image could be processed by image analysis software and the exact size and position of the biological sample determined including any distinctive features defining an orientation of the biological sample wherein a path for the dispenser and a flow rate can be calculated which would exactly cover the biological sample and wherein the camera may provide, in addition to the features above, information regarding the exact outline of the tissue thus providing the ability of a tracer device to draw a bounding outline in a hydrophobic medium and wherein the tracer is capable of movement in the X and/or Y axis for step-wise moving the tracer in an X and/or Y direction to trace the line, i.e., the mask data being the image data comprising the border of the tissue sample comprises instructions for guiding the movement of the marking device to physically trace the region of interest of the sample).
The proposed combination as well as the motivation for combining the Madabhushi, Barnes, and Torre-Bueno references presented in the rejection of Claim 1, applies to claim 2. Thus, the system recited in claim 2 is met by Madabhushi in view of Barnes and Torre-Bueno.
Regarding Claim 3, the combination of references of Madabhushi in view of Barnes and Torre-Bueno teaches "The system of claim 1, wherein determining the geometric registration of the images of the one or more surfaces of the sample to the stained slide image comprises aligning the stained slide image with at least one image of the one or more surfaces"; (Barnes, Para. 19, teaches a fine registration mode used to refine alignment of the first digital image and the second digital image, i.e., determining geometric registration of the images of the one or more surfaces of the sample to the stained slide image comprises aligning the stained slide image with at least one image of the one or more surfaces).
The proposed combination as well as the motivation for combining the Madabhushi, Barnes, and Torre-Bueno references presented in the rejection of Claim 1, applies to claim 3. Thus, the system recited in claim 3 is met by Madabhushi in view of Barnes and Torre-Bueno.
Regarding Claim 4, the combination of references of Madabhushi in view of Barnes and Torre-Bueno teaches "The system of claim 1, wherein receiving the images of the one or more surfaces of the sample comprises generating a first geometric marker on the images of the one or more surfaces"; (Barnes, Paras. 7-8, teaches importing a reference image along with one or more annotations wherein the reference image was digitized from a reference slide scanned on a whole-slide scanner and wherein the annotations were generated using a whole slide viewer interface coupled to the whole-slide scanner in which the one or more annotations may comprise one or more combinations of any geometrical representation depicting one or more regions of interest, i.e., receiving images of the surfaces of the sample comprises generating a first geometric marker on the images of the one or more surfaces being the annotations).
The proposed combination as well as the motivation for combining the Madabhushi, Barnes, and Torre-Bueno references presented in the rejection of Claim 1, applies to claim 4. Thus, the system recited in claim 4 is met by Madabhushi in view of Barnes and Torre-Bueno.
Regarding Claim 7, the combination of references of Madabhushi in view of Barnes and Torre-Bueno teaches "The system of claim 1, wherein receiving the images of the one or more surfaces of the sample comprises receiving dimensional information associated with the sample on the images of the one or more surfaces"; (Madabhushi, Para. 89, teaches the stained whole slide image of a region of tissue comprises a plurality of tumor patches with dimensions of 4000 pixels by 4000 pixels, i.e., receiving images of the one or more surfaces of the samples comprises receiving dimensional information associated with the sample).
Regarding Claim 10, the combination of references of Madabhushi in view of Barnes and Torre-Bueno teaches "The system of claim 7, wherein the dimensional information comprises an area of the sample"; (Madabhushi, Para. 89, teaches the stained whole slide image of a region of tissue comprises a plurality of tumor patches with dimensions of 4000 pixels by 4000 pixels, i.e., receiving images of the one or more surfaces of the samples comprises receiving dimensional information comprising an area of the sample being 4000x4000 pixels).
Claim 11 recites a method with steps corresponding to the elements of the system recited in Claim 1. Therefore, the recited steps of this claim are mapped to the proposed combination in the same manner as the corresponding elements in its corresponding system claim. Additionally, the rationale and motivation to combine the Madabhushi, Barnes, and Torre-Bueno references, presented in rejection of Claim 1, apply to this claim.
Claim 12 recites a method with steps corresponding to the elements of the system recited in Claim 2. Therefore, the recited steps of this claim are mapped to the proposed combination in the same manner as the corresponding elements in its corresponding system claim. Additionally, the rationale and motivation to combine the Madabhushi, Barnes, and Torre-Bueno references, presented in rejection of Claim 1, apply to this claim.
Claim 13 recites a method with steps corresponding to the elements of the system recited in Claim 3. Therefore, the recited steps of this claim are mapped to the proposed combination in the same manner as the corresponding elements in its corresponding system claim. Additionally, the rationale and motivation to combine the Madabhushi, Barnes, and Torre-Bueno references, presented in rejection of Claim 1, apply to this claim.
Claim 14 recites a method with steps corresponding to the elements of the system recited in Claim 4. Therefore, the recited steps of this claim are mapped to the proposed combination in the same manner as the corresponding elements in its corresponding system claim. Additionally, the rationale and motivation to combine the Madabhushi, Barnes, and Torre-Bueno references, presented in rejection of Claim 1, apply to this claim.
Claim 17 recites a method with steps corresponding to the elements of the system recited in Claim 7. Therefore, the recited steps of this claim are mapped to the proposed combination in the same manner as the corresponding elements in its corresponding system claim. Additionally, the rationale and motivation to combine the Madabhushi, Barnes, and Torre-Bueno references, presented in rejection of Claim 1, apply to this claim.
Claim 20 recites a method with steps corresponding to the elements of the system recited in Claim 10. Therefore, the recited steps of this claim are mapped to the proposed combination in the same manner as the corresponding elements in its corresponding system claim. Additionally, the rationale and motivation to combine the Madabhushi, Barnes, and Torre-Bueno references, presented in rejection of Claim 1, apply to this claim.
Claims 5 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Madabhushi in view of Barnes, Torre-Bueno, and Li et al. (US 20240078702 A1).
Regarding Claim 5, the combination of references of Madabhushi in view of Barnes and Torre-Bueno teaches "The system of claim 4, wherein determining the region of interest associated with the sample as a function of the geometric registration comprises: determining the region of interest on the images of one or more surfaces"; (Barnes, Paras. 25-26, teaches transferring or mapping the annotations from one or more reference images to an image of a tissue section subject to dissection using the registration and mapping module wherein annotations depict clinically relevant regions, i.e., determine regions of interest associated with the sample as a function of the registration being the transferring or mapping of annotations using the registration module).
The proposed combination as well as the motivation for combining the Madabhushi, Barnes, and Torre-Bueno references presented in the rejection of Claim 1, applies to claim 5.
However, the combination of references of Madabhushi in view of Barnes and Torre-Bueno does not explicitly teach "and comparing the first geometric marker to a reference frame".
In an analogous field of endeavor, Li teaches "and comparing the first geometric marker to a reference frame"; (Li, Para. 38, teaches comparing the image data of the fiducial marker with a database including one or more reference image data to determine if it is aligned based on a reference point of the fiducial marker, i.e., compare the geometric marker to a reference frame).
It would have been obvious to one having ordinary skill in the art before the effective filing date to modify the invention of Madabhushi, Barnes, and Torre-Bueno by including the comparison of the marker to a reference frame taught by Li. One of ordinary skill in the art would be motivated to combine the references since it improves fiducial quality (Li, Para. 7, teaches the motivation of combination to be to improve fiducial qualities).
Thus, the claimed subject matter would have been obvious to a person having ordinary skill in the art before the effective filing date.
Claim 15 recites a method with steps corresponding to the elements of the system recited in Claim 5. Therefore, the recited steps of this claim are mapped to the proposed combination in the same manner as the corresponding elements in its corresponding system claim. Additionally, the rationale and motivation to combine the Madabhushi, Barnes, Torre-Bueno, and Li references, presented in rejection of Claim 5, apply to this claim.
Claims 6 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Madabhushi in view of Barnes, Torre-Bueno, Li, and Tokushima (US 10788814 B2).
Regarding Claim 6, the combination of references of Madabhushi in view of Barnes, Torre-Bueno, and Li does not explicitly teach "The system of claim 5 wherein comparing the first geometric marker to the reference frame comprises: generating a second geometric marker on the images of the one or more surfaces; and comparing the first geometric marker to the second geometric marker”.
In an analogous field of endeavor, Tokushima teaches "The system of claim 5 wherein comparing the first geometric marker to the reference frame comprises: generating a second geometric marker on the images of the one or more surfaces"; (Tokushima, Claim 1, teaches continuously capturing images of the plurality of marks by comparing each of the captured images with the first reference image wherein the plurality of marks include a first mark and a second mark and wherein locations of the marks are identified when the captured image matches the reference image, i.e., comparing the marker to the reference frame comprising generating a second marker on the images of the surfaces);
"and comparing the first geometric marker to the second geometric marker"; (Tokushima, Claim 1, teaches counting a number of pixels in the captured images that are located at positions between the first location of the first mark and the second location of the second mark, determining a physical quantity amount corresponding to the counted number of pixels, and performing calibration in response to the determined physical quantity amount, i.e., comparing the first and second markers).
It would have been obvious to one having ordinary skill in the art before the effective filing date to modify the invention of Madabhushi, Barnes, Torre-Bueno, and Li by including the generation of a second marker and comparing the two markers taught by Tokushima. One of ordinary skill in the art would be motivated to combine the references since it improves detection accuracy (Tokushima, Col. 7 Lines 8-18, teaches the motivation of combination to be to improve detection accuracy).
Thus, the claimed subject matter would have been obvious to a person having ordinary skill in the art before the effective filing date.
Claim 16 recites a method with steps corresponding to the elements of the system recited in Claim 6. Therefore, the recited steps of this claim are mapped to the proposed combination in the same manner as the corresponding elements in its corresponding system claim. Additionally, the rationale and motivation to combine the Madabhushi, Barnes, Torre-Bueno, Li, and Tokushima references, presented in rejection of Claim 6, apply to this claim.
Claims 8 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Madabhushi in view of Barnes, Torre-Bueno, and Nguyen et al. (US 20230016472 A1).
Regarding Claim 8, the combination of references of Madabhushi in view of Barnes and Torre-Bueno does not explicitly teach "The system of claim 7, wherein receiving the stained slide image of the sample comprises selecting the stained slide image as a function of the dimensional information".
In an analogous field of endeavor, Nguyen teaches "The system of claim 7, receiving the stained slide image of the sample comprises selecting the stained slide image as a function of the dimensional information"; (Nguyen, Para. 7, teaches the selection of particular image augmentations performed on the whole slide images for the unique and specific aspects of the whole slide image such as how color and scale plays an important role in analysis of H&E images since cells with different sizes and colors may have different biological meanings, i.e., selecting the stained slide image as a function of the dimensional information being the size information of the sample).
It would have been obvious to one having ordinary skill in the art before the effective filing date to modify the invention of Madabhushi, Barnes, and Torre-Bueno by including the selecting of the stained slide image as a function of dimensional information taught by Nguyen. One of ordinary skill in the art would be motivated to combine the references since it improves the quality of the features (Nguyen, Para. 49, teaches the motivation of combination to be improve the quality of features).
Thus, the claimed subject matter would have been obvious to a person having ordinary skill in the art before the effective filing date.
Claim 18 recites a method with steps corresponding to the elements of the system recited in Claim 8. Therefore, the recited steps of this claim are mapped to the proposed combination in the same manner as the corresponding elements in its corresponding system claim. Additionally, the rationale and motivation to combine the Madabhushi, Barnes, Torre-Bueno, and Nguyen references, presented in rejection of Claim 8, apply to this claim.
Claims 9 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Madabhushi in view of Barnes, Torre-Bueno, and Zuiderveld et al. (US 20240070904 A1).
Regarding Claim 9, the combination of references of Madabhushi in view of Barnes and Torre-Bueno does not explicitly teach "The system of claim 7, wherein the dimensional information comprises a tissue thickness of the sample".
In an analogous field of endeavor, Zuiderveld teaches "The system of claim 7, wherein the dimensional information comprises a tissue thickness of the sample"; (Zuiderveld, Para. 3, teaches tissue samples may be sliced to obtain a series of sections with each section having a thickness of 4-5 microns for example wherein each section may be mounted on a slide and scanned to create a digital image for examination, i.e., dimensional information comprises tissue thickness of the sample).
It would have been obvious to one having ordinary skill in the art before the effective filing date to modify the invention of Madabhushi, Barnes, and Torre-Bueno by including the dimensional information comprising tissue thickness taught by Zuiderveld. One of ordinary skill in the art would be motivated to combine the references since enables extracting quantitative measures (Zuiderveld, Para. 3, teaches the motivation of combination to be to enable extracting meaningful quantitative measures using image analysis).
Thus, the claimed subject matter would have been obvious to a person having ordinary skill in the art before the effective filing date.
Claim 19 recites a method with steps corresponding to the elements of the system recited in Claim 9. Therefore, the recited steps of this claim are mapped to the proposed combination in the same manner as the corresponding elements in its corresponding system claim. Additionally, the rationale and motivation to combine the Madabhushi, Barnes, Torre-Bueno, and Zuiderveld references, presented in rejection of Claim 9, apply to this claim.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee 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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/ANDREW S BUDISALICH/Examiner, Art Unit 2662
/AMANDEEP SAINI/Supervisory Patent Examiner, Art Unit 2662
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