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 have been examined. Claims 1, 11 have been amended.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
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Claims 1, 11 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 10 of U.S. Patent No. 12,217,837. Although the claims at issue are not identical, they are not patentably distinct from each other because both claims recite a system/method for digitization of tissue slides based on associations among serial sections. The claims differ in that claim 1 and 11 of the current application recite retrieving a first (binary mask), a second map (candidate binary mask), whereas claim 1, 11 of US Patent No. 12,217,837 recite retrieving a candidate tissue map and retrieve a reference tissue associated with a reference tissue section.
Claim Rejections - 35 USC § 103
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 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 ahrens et al. (EP2783716A1 hereinafter Ahrens)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.
Claims 1-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Barnes et al. (US 20220156930A1 hereinafter Barnes) in view of Khademi et al. (US 20210158523A1 hereinafter Khademi) and further in view of Yip et al. (US20220101519A1 hereinafter Yip).
With respect to claim 1, Barnes teaches a system for digitization of tissue slides based on associations among serial sections (‘930; Para 0064: Once the image data is received (S401), an image in a series of images corresponding to slides comprising serial tissue sections may be displayed on a user interface for field-of-view (FOV) selection and annotation), wherein the system is comprised of:
at least a computing device, wherein the at least a computing device is comprised of:
a memory, wherein the memory stores instructions; and
a processor, communicatively connected to the memory, wherein the processor is configured to:
retrieve a first map comprising a reference tissue map (‘930; Para 0077: in the automated mode, either an Area of Interest (AoI) detector finds or identifies a tissue region in the whole slide image or the tissue annotations are automatically generated by some other image analysis algorithm, such as image registration algorithm which maps annotations from the adjacent serial section to the IHC tissue slide);
retrieve a second map comprising a candidate tissue map, wherein the second map comprises a slide that is digitized using a scanner (‘930; Para 0035: a series of histopathological simplex and/or multiplex tissue slides from serial sections of cancerous tissue block corresponding to each patient and stained with H&E and multiple IHC tumor and immune markers (such as tumor markers ER, PR, Ki67, HER2, etc. and/or immune markers such as CD3, CD8, CD4 etc.) are digitized using a digital pathology scanning system, for example, on a whole slide scanner or a digital microscope; Para 0077: after detecting candidate nuclei, algorithms can be used automatically to provide a score or information about the entire analyzed image. The selection criteria can be modified or determined based at least in part on reference images. For example, reference images of stained breast tissue can be used to determine selection criteria used to select nuclei of an image of breast tissue from a subject. In some embodiments, the user can delete any areas of interest on a slide-by-slide basis);
Barnes does not explicitly disclose a reference binary mask and candidate binary mask.
However, Khademi teaches evaluating resolution and patient (i.e. subject) orientation normalization, two tests may be used to assess image registration accuracy. The Dice Similarity Coefficient (DSC) can be used to measure the amount of overlap between the binary masks of each image (i.e. candidate) and the atlas (i.e. reference), before and after image standardization using equation 12 as described in Para 0169-0170 (‘523; Para 0171),
Khamedi further discloses the intensity standardized image volume may be registered to the image atlas volume to spatially align the former to the latter. Registration may be accomplished using affine registration or other image registration techniques such as non-rigid registration, as is known by those skilled in the art [26, 27]. It may be noted that the affine registration of intensity standardized images may provide more consistent registration results compared to aligning non-standardized image volumes on the basis that the value of tissue intensities become more consistent between image volumes (’523; Para 0156)
align, using a registration module, the second map (‘523; Para 0156);
generate a regenerated second map as a function of the first map, wherein the regenerated second map is digital, wherein generating the regenerated second map comprises generating a reference binary mask from the first map and a candidate binary mask from the second map, aligning the reference binary mask and the candidate binary mask based on results of the alignment of the second map, adjusting the candidate binary mask based on the reference binary mask to generate a corrected candidate binary mask, and applying the corrected candidate binary mask onto the second map to generate the regenerated second map (‘523; Para 0007: processing a digital magnetic resonance (MR) image volume from an image data set is provided herein where the method involves performing intensity standardization and the method comprises scaling intensity values of the digital MR image volume based on an image volume scaling factor to align an image volume landmark of a volume histogram of the digital MR image volume with a reference volume landmark of a reference histogram of a reference image volume to generate a scaled digital MR image volume; separating the scaled digital MR image volume into a plurality of scaled digital MR image slices; for each scaled digital MR image slice: generating an image slice histogram; determining an image slice landmark from the image slice histogram; and generating a scaled and shifted digital MR image slice by shifting image slice intensity values by an image slice shifting factor to align the image slice landmark with the image volume landmark.); and
It would have been obvious to one of ordinary skill in the art before the effective filing date of claimed invention to modify the histopathological tissue slide analysis of Barnes with the technique of standardized processing of MR images as taught by Khademi in order to provide a reference binary mask and candidate binary mask in tissue repository.
Yip teaches
select a scan parameter as a function of the regenerated second map (‘519; Para 0123), wherein the scan parameter is configured to instruct the scanner; and
the scanner, wherein the scanner is configured to:
scan at least a slide as a function of the scan parameter (‘519; Para 0050: a computing device configured to identifying biomarkers in digital image of a Hematoxylin and eosin (H&E) stained slide of target tissue, the computing device comprises: one or more memories; and one or more processors configured to, receive the digital image; perform an image tiling process on the digital image by separating the digital image into a plurality of tile images, where each of the plurality of tile images contains a different portion of the digital image; apply the plurality of tile images to a multiscale deep learning framework comprising one or more trained deep learning multiscale classifier models; Para 0094: ), and
send a digitized image of the at least a slide to the at least a computing device (‘519; Para 0123: The imaging-based biomarker prediction system 102 may further send generated reports to a computer system 120 of the patient's primary care provider and to a physician clinical records system 122 for databasing the patients report with previously generated reports on the patient and/or with databases of generated reports on other patients for use in future patient analyses, including deep learning analyses ) (‘288; Para 0192: enabling customers to view data through a web browser, store de-identified patient information associated with the tissue and digitized whole slide images that the tissue repository scans, and slide digitization for creating a training data set for automated diagnostic algorithms.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of claimed invention to modify the histopathological tissue slide analysis of Barnes/Khamedi with the technique of determining biomarkers from histopathology slide image as taught by Yip in order to provide a digitized image in tissue repository.
Claim 11 is rejected as the same reason with claim 1.
With respect to claim 2, the combined art teaches the system of claim 1, Khamedi discloses wherein: the first map is associated with a first section; and the second map is associated with a second section (‘523; Abstract)).
Claim 12 is rejected as the same reason with claim 2.
With respect to claim 3, the combined art teaches the system of claim 2, Barnes discloses wherein: the first section comprises a Hematoxylin and Eosin (H&E)-stained slide; and the second section comprises a non-H&E-stained slide (‘930; Para 0042: a whole tumor region annotated on a Hematoxylin and Eosin (H&E) slide from among the plurality of serial slides may be selected automatically or by a pathologist on an interface such as VIRTUOSO/VERSO™ or similar).
Claim 13 is rejected as the same reason with claim 3.
With respect to claim 4, the combined art teaches the system of claim 2, Barnes discloses wherein retrieving the second map comprises identifying the second section as a function of stain information, wherein the stain information comprises a stain type (‘930; Para 0065).
Claim 14 is rejected as the same reason with claim 4.
With respect to claim 5, the combined art teaches the system of claim 2, Barnes discloses wherein retrieving the first map comprises identifying the first section as a function of an identification number and a block identification number (‘930; Paras 0018: The tissue slices may be marked by single or multiple stains for the identification of respective biological features. A digital image is acquired from each of the marked tissue slices by means of an image sensor that has a number of color channels, such as an RGB image sensor.).
Claim 15 is rejected as the same reason with claim 5.
With respect to claim 6, the combined art teaches the system of claim 1, Khamedi discloses wherein the registration module comprises an inline computing program (‘523; Para 0097).
Claim 16 is rejected as the same reason with claim 6.
With respect to claim 7, the combined art teaches the system of claim 1, Barnes discloses wherein aligning the second map comprises: receiving a user input from a user interface, wherein the user input indicates a location of a feature of the first map; and aligning, using the registration module, the second map to the first map as a function of the user input (‘930; Paras 0021-0022: The images are aligned in accordance with the image registration. In other words, the geometrical transformations that are generated by the image registration algorithm are applied to the images for aligning the images such as to display the aligned images on a display in a two-dimensional plane).
Claim 17 is rejected as the same reason with claim 7.
With respect to claim 8, the combined art teaches the system of claim 1, Yip discloses wherein generating the regenerated second map is configured for avoiding untimely detection of errors (‘519; Para 0377, 0389-0390).
Claim 18 is rejected as the same reason with claim 8.
With respect to claim 9, the combined art teaches the system of claim 1, Yip discloses wherein the scan parameter comprises a magnification level (‘519; Paras 0116: The histopathology images may be images captured by any dedicated digital medical image scanners, e.g., any suitable optical histopathology slide scanner including 20× and 40× resolution magnification scanners).
Claim 19 is rejected as the same reason with claim 9.
With respect to claim 10, the combined art teaches the system of claim 1, Yip discloses wherein the scan parameter comprises a resolution level (‘519; Paras 0116, 0119: resolution).
Claim 20 is rejected as the same reason with claim 10.
Response to Arguments
Applicant’s arguments, see Remark, filed 06/04/2026, with respect to the rejection(s) of claim(s) 1 and 11 under 35USC103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made of Barnes in view of Khamedi/Yip.
For claim rejection under 35USC101, the Applicant argued that the claimed amendment requires generating a reference binary mask from the first map and candidate binary mask from the second map…is not to an abstract idea. The claim rejection under 35USC101 have been fully considered and are persuasive. The claim rejection under 35USC101 has been withdrawn.
For Double Patenting rejection. Claims 1, 11 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 10 of U.S. Patent No. 12,217,837. Although the claims at issue are not identical, they are not patentably distinct from each other because both claims recite a system/method for digitization of tissue slides based on associations among serial sections. The claims differ in that claim 1 and 11 of the current application recite retrieving a first (binary mask), a second map (candidate binary mask), whereas claim 1, 11 of US Patent No. 12,217,837 recite retrieving a candidate tissue map and retrieve a reference tissue associated with a reference tissue section.
Therefore, the Examiner maintains double patenting rejection of all claims.
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.
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/HIEP V NGUYEN/Primary Examiner, Art Unit 3686
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