DETAILED ACTIONS
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 .
Priority
Acknowledgment is made of applicant’s claim this application being a Continuation of Application No. 16/951,854, filed on November 18th, 2020, and benefit of Provisional Application No. 62/937,066 filed on November 18th, 2019.
Information Disclosure Statement
The information disclosure statement (“IDS”) filed on 08/19/2025 was reviewed and the listed references were noted.
Drawings
The 32-page drawings have been considered and placed on record in the file.
Status of Claims
Claims 1-2, 5-6, 8-9, 14-16, 21-31, and 33-34 are pending. Claims 3-4, 7, 10-13, 17-20, and 32 are canceled.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 14 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 14 is dependent upon cancelled claim 12. For the purpose of furthering further prosecution, Examiner has interpreted claim 14 to be dependent upon claim 9 for claiming the limitation “capture spot”. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim 15 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 15 is dependent upon cancelled claim 12. For the purpose of furthering further prosecution, Examiner has interpreted claim 15 to be dependent upon claim 9 for claiming the limitation “capture spot”. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-2, 5-6, 8-9, 14-16, 21-31, and 33-34 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 12,154,266 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1 and 19 of U.S. Patent No. 12,154,266 B2 anticipated claims 1 and 34 of the present invention. Claims 2, 5-6, 8-9, 14-16, 21-31, and 33 are also rejected for being dependent upon claim 1.
Instant Application (18/920,755)
U.S. Patent No. 12,154,266
Claim 1: A method of :
assigning each respective pixel in a plurality of pixels of an image of a tissue sample on a substrate to a first class or a second class, wherein the image includes a plurality of fiducial markers on an outer boundary of the substrate, the first class indicates overlay of the tissue sample on the substrate and the second class indicates background, and the plurality of pixels comprises at least 100,000 pixels, the method comprising:
(i) using the plurality of fiducial markers to define a bounding box within the image,
(ii) removing respective pixels falling outside the bounding box from the plurality of pixels,
(iii) running, after the removing (ii), a plurality of heuristic classifiers on the plurality of pixels, wherein, for each respective pixel in the plurality of pixels, for each respective heuristic classifier in the plurality of heuristic classifiers, the respective heuristic classifier casts a corresponding vote for the respective pixel between the first class and the second class, thereby obtaining a corresponding plurality of votes for the respective pixels,
(iv)forming, for each respective pixel in the plurality of pixels, a corresponding aggregated score for the respective pixel using the corresponding plurality of votes, wherein each corresponding aggregated score is a class in a set of classes, and
(v) applying, after the forming (iv). the aggregated score and intensity of each respective pixel in the plurality of pixels to a segmentation algorithm to independently assign a probability to each respective pixel in the plurality of pixels of being tissue sample or background.
Claim 1: A tissue classification method comprising:
A) obtaining an image of a tissue sample on a substrate, as a plurality of pixels in electronic form, wherein the image includes a plurality of fiducial markers on an outer boundary of the substrate; and
B) assigning each respective pixel in the plurality of pixels to a first class or a second class, wherein the first class indicates overlay of the tissue sample on the substrate and the second class indicates background, and wherein the plurality of pixels comprises at least 100,000 pixels, by a procedure that comprises:
(i) using the plurality of fiducial markers to define a bounding box within the image,
(ii) removing respective pixels falling outside the bounding box from the plurality of pixels,
(iii) running, after the removing (ii), a plurality of three or more heuristic classifiers on the plurality of pixels, wherein, for each respective pixel in the plurality of pixels, for each respective heuristic classifier in the plurality of heuristic classifiers, the respective heuristic classifier casts a corresponding vote for the respective pixel between the first class and the second class, thereby obtaining a corresponding plurality of votes for the respective pixels,
(iv) forming, for each respective pixel in the plurality of pixels, a corresponding aggregated score for the respective pixel using the corresponding plurality of votes, wherein each corresponding aggregated score is a class in a set of classes comprising obvious first class, likely first class, likely second class, and obvious second class, and
(v) applying, after the forming (iv), the aggregated score and intensity of each respective pixel in the plurality of pixels to a segmentation algorithm to independently assign a probability to each respective pixel in the plurality of pixels of being tissue sample or background.
Allowable Subject Matter
Claims 1-2, 5-6, 8-9, 14-16, 21-31, and 33-34 would be allowable if the double patenting rejections and 112(d) rejections were overcome.
The following is an examiner’s statement of reasons for allowance: The claimed features such as “assigning each respective pixel a plurality of pixels of an image of a tissue sample on a substrate to a first class or a second class, wherein the image includes a plurality of fiducial markers on an outer boundary of the substrate, the first class indicates overlay of the tissue sample on the substrate and the second class indicates background, and the plurality of pixels comprises at least 100,000 pixel", "using the plurality of fiducial markers to define a bounding box within the image", "removing respective pixels falling outside the bounding box from the plurality of pixels” and “wherein, for each respective pixel in the plurality of pixels, for each respective heuristic classifier in the plurality of heuristic classifiers, the respective heuristic classifier casts a corresponding vote for the respective pixel between the first class and the second class, thereby obtaining a corresponding plurality of votes for the respective pixels” claimed in independent claims 1 and 34, in combination with the remainder of the limitations of the claims, are neither anticipated nor obvious in view of the prior art of record.
In one of the closest prior art, King (US 20080247647 A1), teaches generating heuristic metrics. However, King does not disclose generating heuristic metrics for each pixel on the image. The claim limitation requires that for each respective pixel in the plurality of pixels, for each respective heuristic classifier in the plurality of heuristic classifiers, the respective heuristic classifier casts a corresponding vote for the respective pixel. King discloses in paragraph 0049 that each heuristic is used to give an input channel a score and that the pixels which comprise the same colors (or fulfill a threshold value for fuzzy membership with that color) can be grouped together, or characterized as such, to create a channel. Therefore, King does not explicitly disclose “wherein, for each respective pixel in the plurality of pixels, for each respective heuristic classifier in the plurality of heuristic classifiers, the respective heuristic classifier casts a corresponding vote for the respective pixel” as required by claims 1 and 34.
Also, in one of the closest prior art, Gala “Computer assisted detection of axonal bouton structural plasticity in in vivo timelapse images” (2017), teaches using a fiducial marker as a rectangle around the ROI in page 15. However, the fiducial marker was on the brain’s surface rather than the outer boundary of the substrate or the glass slide as the claim requires. Therefore, Gala does not explicitly disclose “wherein the image includes a plurality of fiducial markers on an outer boundary of the surface, assigning each respective pixel in the plurality of pixels to a first class or a second class, wherein the first class indicates overlay of the tissue sample on the substrate and the second class indicates background by using the plurality of fiducial markers to define a bounding box within the image and removing respective pixels falling outside the bounding box from the plurality of pixels” as required by claims 1 and 34.
Because the cited prior art of records does not teach or suggest each and every feature of independent claims 1 and 34, these claim would be allowable if the double patenting rejections and 112(d) rejections were overcome. Claims 2, 5-6, 8-9, 14-16, 21-31, and 33 would be allowable by virtue of their dependency on independent claim 1.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DENISE G ALFONSO whose telephone number is (571)272-1360. The examiner can normally be reached Monday - Friday 7:30 - 5:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amandeep Saini can be reached at (571)272-3382. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DENISE G ALFONSO/Examiner, Art Unit 2662
/AMANDEEP SAINI/Supervisory Patent Examiner, Art Unit 2662
