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 .
Claim Objections
Claim 9 is objected to because of the following informalities: In claim 9, Examiner suggests correcting the limitation “wherein detecting the position…” to read as “wherein detecting includes detecting the position…” for purposes of clarity. Appropriate correction is required.
Response to Arguments
Applicant’s arguments, see Remarks, filed 01/06/2026, with respect to the rejection of claims 1-9 and 11-20 under 35 USC 101 have been fully considered and are persuasive. The rejection of claims 1-9 and 11-20 under 35 USC 101 has been withdrawn.
The Amendment filed 01/06/2026 partially overcomes the rejection of claims 1-9 and 11-20 under 35 USC 112(b). New grounds of rejection under 35 USC 112(b) with respect to claims 7-8 and 17-18 are set forth below as necessitated by the amendment.
Applicant’s arguments with respect to the rejection of claim(s) 1-9 and 11-20 under 35 USC 102 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Claim Rejections - 35 USC § 112
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 7-8 and 17-18 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.
In claims 7 and 17, it is unclear if “receiving designation of an additional region other than the divided region” is directed to designation of an additional divided region of the originally designated region of claim 1, or if the designation is meant to be of an additional region of the image other than the region designated in claim 1. Additionally, it is unclear what is meant by “each divided region obtained by division”, as the claims do not clearly indicate what is the subject of the division. Examiner notes that correction similar to the current amendment to claims 1 and 11 may overcome this rejection. For purposes of examination, the claims will be interpreted according to Examiner’s best understanding of Applicant’s specification and given the broadest reasonable interpretation in view of available prior art. Claims 8 and 18 are additionally rejected for inheriting the deficiencies of claims 7 and 17, respectively.
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 (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.
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.
Claims 1, 3-5, 7-9. 11, 13, 15 and 17-20 are rejected under 35 U.S.C. 103 as being unpatentable over US PG PUB. 2017/0270666 A1 (hereinafter “Barnes”; applicant-submitted prior art) in view of US PG PUB. 2015/0147772 A1 (hereinafter “Yoshihara”).
Regarding claim 1, Barnes teaches an inspection assistance device (Barnes, Fig. 1, ¶0041-0050) comprising:
a memory configured to store instructions (Barnes, Fig. 1, memory 110); and
at least one processor configured to execute the instructions to perform (Barnes, Fig. 1, processor 105 coupled to computer 101):
acquiring a pathology specimen image (Barnes, ¶0041-0042; “input data 102 may provide a means for inputting image data from one or more scanned IHC slides to memory 110.”);
receiving designation of a region for the acquired pathology specimen image (Barnes, ¶0043; “Once the image data is received…a user interface may be provided by a field-of-view (FOV) selection module 111 that enables selection of a region of an IHC image for further analysis by the other modules. A pathologist operating the terminal may select the FOV using the user interface. Several FOV selection mechanisms may be provided, such as designating known or irregular shapes, or defining an anatomic region of interest (e.g., tumor region). In one example, the field of view is a whole-tumor region selected on an IHC image stained with an H&E stain combination. The FOV selection may be performed by a pathologist or by automated image-analysis algorithms, such as tumor region segmentation on an H&E tissue slide”);
detecting a position of a tumor cell and a position of a non-tumor cell in the pathology specimen image in the designated region; and calculating a tumor cell content rate for each divided region obtained by division of the pathology specimen image in the designated region by a predetermined size based on the detected position of the tumor cell and the detected position of the non-tumor cell (Barnes, ¶0078; “In the FOV mode, a user, such as a pathologist, outlines or “annotates” a number of regions (e.g., three or more regions) in a whole slide image and the analysis algorithm is performed with respect to the annotated regions. A final composite score is obtained based at least in part on the number of positive and negative tumor nuclei detected in all these annotated regions. 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. The tissue region is then segmented into tiles and classification and nuclei counting algorithms are performed with respect to each tile that contains tissue. Additionally, a composite score can be obtained based at least in part on the image tiles containing tissue. ”);
outputting the pathology specimen image in a mode in which the tumor cell content rate for the each divided region is allowed to be grasped (Barnes, ¶0041, 0054, 0073; “processor 105 executes logical instructions stored on memory 110, performing image analysis and other quantitative operations resulting in an output of results to a user operating computer 101 or via a network” wherein “when a new slide series comprising H&E and IHC slides from a new patient is input into system 100, and annotations generated and FOVs analyzed using image analysis algorithms to output scores” and “an overlay image is produced to label features of interest in the image of a specimen from a subject”).
Barnes does not expressly teach the limitations as further claimed, but, in an analogous field of endeavor, Yoshihara does as follows.
Yoshihara teaches receiving selection of a divided region from among the divided regions for which the tumor cell content rate is allowed to be grasped; and outputting information about the tumor cell content rate in the divided region whose selection was received, wherein the information about the tumor cell content rate includes information indicating at least one of the number of tumor cells and the number of non-tumor cells in the divided region whose selection was received (Yoshihara, Fig. 13, ¶0074-0078; “meshes are superimposed on a selected area, and a user is requested to select meshes for determining scores thereof… When a selection instruction was made, meshes specified according to the selection instruction are acquired in a sequence S1209. The client PC 220 sends information (the mesh number or mesh position information) on the meshes selected in a sequence S1211 to the pathological image diagnosis support apparatus 200. The pathological image diagnosis support apparatus 200 counts the number of cells in each selected mesh in a sequence S1213 and sends the counted number of cancer cells in each selected mesh in a sequence S1215 to the client PC 220.”).
Yoshihara is considered analogous art because it pertains to a pathological image diagnosis support system. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device taught by Barnes to include the ability to accept user selection of specific image tiles within which to perform the counting of cancerous cells and outputting the count for the selected tile, as taught by Yoshihara, in order to provide a more accurate diagnosis when the cancer cells are spread across the selected area of interest (Yoshihara, ¶0074).
Regarding claim 3, claim 1 is incorporated, and Barnes in the combination further teaches wherein the at least one processor is configured to execute the instructions to perform: outputting the pathology specimen image indicating the tumor cell content rate for the each divided region by a heat map (Barnes, ¶0045; “A heat map may be generated given annotations on a first slide, such as a Ki67 slide, and regions in the heat map which are locally dominant may be considered to be hot spots, possibly which a qualified reader such as a pathologist considers to be important. Visually, the heat map presents a high-level overview of the scoring metric of interest. For instance, a heat map of a Ki67 slide is indicative of the percent positivity in the tumor region, and used to generate the FOV that is registered on adjacent IHC slides”).
Regarding claim 5, claim 1 is incorporated, and Barnes in the combination further teaches wherein the at least one processor is configured to execute the instructions to perform: outputting, as information about the tumor cell content rate, information indicating at least one of the position of the tumor cell and the position of the non-tumor cell in the divided region whose selection was received (Barnes, Fig. 2B, ¶0073; “the system counts positively-stained nuclear objects and/or negatively-stained nuclear objects to score, for example, a biological specimen (e.g., tumor tissue). In some embodiments, an overlay image is produced to label features of interest in the image of a specimen from a subject.”).
Regarding claim 7, claim 1 is incorporated, and Barnes in the combination further teaches further comprising: the at least one processor is configured to execute the instructions to perform: receiving designation of an additional region other than the divided region, detecting a position of a tumor cell and a position of a non-tumor cell from the pathology specimen image in the designated additional region, and calculating a tumor cell content rate for each divided region obtained by division by a predetermined size based on the detected position of the tumor cell and the detected position of the non-tumor cell in the additional region (Barnes, ¶0073, 0078; “In the FOV mode, a user, such as a pathologist, outlines or “annotates” a number of regions (e.g., three or more regions) in a whole slide image and the analysis algorithm is performed with respect to the annotated regions.”).
Regarding claim 8, claim 7 is incorporated, and Barnes in the combination further teaches wherein the at least one processor is configured to execute the instructions to perform: outputting the pathology specimen image in a mode in which the tumor cell content rate for the each divided region in the additional region is allowed to be grasped (Barnes, ¶0073; “the system can accurately count nuclear objects to determine information about the tissue to assist with reliable and reproducible slide interpretation. In one embodiment, the system counts positively-stained nuclear objects and/or negatively-stained nuclear objects to score, for example, a biological specimen (e.g., tumor tissue). In some embodiments, an overlay image is produced to label features of interest in the image of a specimen from a subject. ”).
Regarding claim 9, claim 1 is incorporated, and Barnes in the combination further teaches wherein detecting the position of the tumor cell and the position of the non-tumor cell using a trained model generated by machine learning in which image characteristics of a tumor cell and image characteristics of a non-tumor cell are learned (Barnes, ¶0073; “The system can have a classifier that was trained based at least in part on a set of training or reference slides for each marker, for example a biomarker…The trained classifier can be selected based at least in part on how best to handle training data variability, for example, in tissue type, staining protocol, and other features of interest, for slide interpretation. The system can analyze a specific region of an image based at least in part on information within that region, as well as information outside of that region. In some embodiments, a multi-stage binary classifier can identify positive and negative nuclei.”).
Claim 11 recites a method having features which correspond directly to the elements of device claim 1, the rejection of which is applicable here.
Claim 13 recites a method having features which correspond directly to the elements of device claim 3, the rejection of which is applicable here.
Claim 15 recites a method having features which correspond directly to the elements of device claim 5, the rejection of which is applicable here.
Claim 17 recites a method having features which correspond directly to the elements of device claim 7, the rejection of which is applicable here.
Claim 18 recites a method having features which correspond directly to the elements of device claim 8, the rejection of which is applicable here.
Claim 19 recites a method having features which correspond directly to the elements of device claim 9, the rejection of which is applicable here.
Claim 20 recites a non-transitory recording medium storing a program having features which correspond directly to the elements of device claim 1, the rejection of which is applicable here, and Barnes in the combination further teaches a non-transitory recording medium storing a program (Barnes, ¶0055; “Logic may be formed from signals stored on a computer-readable medium such as memory 110 that, in an exemplary embodiment, may be a random access memory (RAM), read-only memories (ROM), erasable/electrically erasable programmable read-only memories (EPROMS/EEPROMS), flash memories, etc.”).
Claims 21-22 are rejected under 35 U.S.C. 103 as being unpatentable over the combination of Barnes in view of Yoshihara, as applied to claims 1 and 11 above, and further in view of “Calculating the Tumor Nuclei Content for Comprehensive Cancer Panel Testing” (hereinafter “Mikubo”).
Regarding claim 21, claim 1 is incorporated, and neither Barnes nor Yoshihara in the combination expressly teaches the limitations as further claimed, but, in an analogous field of endeavor, Mikubo does as follows.
Mikubo teaches wherein the outputting supports decision making for identifying a region suitable for a genetic panel test based on the calculated tumor cell content rate (Mikubo, Introduction; “evaluating the tumor content of specimens before CGP testing and selecting specimens with tissue samples with a tumor cell content of 20% or more is important to ensure the highest-quality results and achieve assay performance comparable to that of the validation studies.”).
Mikubo is considered analogous art because it pertains to determining tumor cell content of pathology images for diagnostic purposes. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device taught by the combination of Barnes and Yoshihara to include identification of specimens suitable for further genetic panel testing based on the calculated tumor cell content, as taught by Mikubo, in order to ensure high-quality panel testing performance and results (Mikuobo, Introduction).
Claim 22 recites a method having features which correspond directly to the elements of device claim 22, the rejection of which is applicable here.
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.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SAMAH A BEG whose telephone number is (571)270-7912. The examiner can normally be reached M-F 9 AM - 5 PM.
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/SAMAH A BEG/Primary Examiner, Art Unit 2676