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 .
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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Claim 1 (and by dependency claims 2-13 and 15-20) are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 12051203. Although the claims at issue are not identical, they are not patentably distinct from each other because the initial wording differences are in the preamble and not the body of the claim, and otherwise the claim is a slightly broader version of claim 1 of U.S. Patent No. 12051203. “Adjusting” in the current application is considered equivalent to “correcting” in claim 1 of U.S. Patent No. 12051203.
Current Application
1. A computer-implemented method for evaluating a tissue in a subject, the method comprising the processor-executed steps of: analyzing a radiological image of the tissue to calculate a raw value indicative of a biological parameter of the tissue; analyzing a microscopy image of the tissue to identify a distribution of cells of interest within the tissue; and adjusting the raw value based on the identified distribution of cells of interest within the tissue.
US 12051203 B2
1. A computer-implemented method for calibrating radiological data associated with a tissue in a subject, the method comprising the processor-executed steps of: analyzing a radiological image of the tissue to calculate a raw value indicative of a biological parameter in the tissue; analyzing a microscopy image of the tissue to identify a distribution of cells of interest within the tissue; and calculating a calibrated value indicative of a biological parameter of cells of interest within the tissue, wherein the calibrated value is obtained by correcting the raw value based on the identified distribution of cells of interest within the tissue.
Claim 14 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 14 of U.S. Patent No. 12051203. Although the claims at issue are not identical, they are not patentably distinct from each other because the initial wording differences are in the preamble and not the body of the claim, and otherwise the claim is a slightly broader version of claim 1 of U.S. Patent No. 12051203. “Adjust” in the current application is considered equivalent to “correcting” in claim 1 of U.S. Patent No. 12051203.
Current Application
14. A system for evaluating radiological data associated with a tissue in a subject, the system comprising: an interface for receiving a radiological image of the tissue and a microscopy image of the tissue; a memory; and a processor configured to execute instructions stored on the memory to: (i) calculate a raw value indicative of a biological parameter of the tissue from the radiological image; (ii) identify a distribution of cells of interest within the tissue from the microscopy image; and (iii) adjust the raw value based on the identified distribution of cells of interest within the tissue.
US 12051203 B2
14. A system for calibrating radiological data associated with a tissue in a subject, the system comprising: an interface for receiving a radiological image of the tissue and a microscopy image of the tissue; a memory; and a processor configured to execute instructions stored on the memory to: (i) calculate a raw value indicative of a biological parameter in the tissue from the radiological image; (ii) identify a distribution of cells of interest within the tissue from the microscopy image; and (iii) calculate a calibrated value indicative of a biological parameter of cells of interest within the tissue, by correcting the raw value based on the identified distribution of cells of interest within the tissue.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. US 12377054 B2 (FIGS. 1A-G are diagrams showing an overview of mTOR-HDL nanoimmunotherapy, allograft model, biodistribution and immune cell targeting. FIG. 1A is a diagram showing that mTOR-HDL nanoparticles, synthesized from phospholipids, human APOA1 and rapamycin, had a discoidal shape as evaluated by transmission electron microscopy (TEM) and that they can be radiolabeled with .sup.89Zr. FIG. 1B is a schematic showing BALB/c donor hearts (H2d) transplanted into fully allogeneic C57BL/6 recipients (H2b) receiving mTOR nanoimmunotherapy, which are either radiolabeled for PET imaging and biodistribution, or fluorescently labeled for distribution among cell subsets of the innate and adaptive immune system. The image data were normalized to correct for PET response non-uniformity, dead-time count losses, positron branching ratio and physical decay to the time of injection, but no attenuation, scatter or partial-volume averaging correction was applied. The counting rates in the reconstructed images were convened to activity concentrations (percentage injected dose [% ID] per gram of tissue) using a system calibration factor derived from imaging a mouse-sized water-equivalent phantom containing .sup.89Zr. Images were analyzed using ASIPro VMTM software (Concorde Microsystems, Knoxville, TN, USA)); US 20190294859 A1 (The present invention relates to an apparatus (10) for determining cellular composition in one or more tissue sample microscopic images. It is described to provide (210) first image data of at least one tissue sample. The first image data relates to a non-specific staining of a tissue sample of the at least one tissue sample. Second image data of the at least one tissue sample is provided (220). The second image data relates to specific staining of a tissue sample of the at least one tissue sample. Either (i) the tissue sample that has undergone specific staining is the same as the tissue sample that has undergone non-specific staining, or (ii) the tissue sample that has undergone specific staining is different to the tissue sample that has undergone non-specific staining. A non-specific cellular composition cell density map is determined (230) on the basis of the first image data. A specific cellular composition cell density map is determined (240) on the basis of the second image data. Information regarding cellular composition in the at least one tissue sample is determined (250) on the basis of the non-specific cell density map and the specific cell density map. In this way imaging errors when simultaneously imaging two markers is mitigated, and processing is simplified as de-convolution of image data relating to two markers is not required. Image registration, for example through matching of one or more features in one image with one or more features in another image, then enables the spatial position of cell densities in one image to be compared correctly with the spatial cell densities in another image); US 20160303258 A1 (The .sup.111In-MLN6907 precursor can differentiate antigen density in nonclinical proof of concept studies. The left column shows light microscopy images of three cell types, with the highest expresser of GCC on top and the lowest expresser of GCC on the bottom. Images will be presented to the expert reader with and without co-registered CT, MRI, or FDG-PET images for review. Partial volume effect (PVE) correction is routinely used in PET imaging to improve quantification accuracy resulting from low spatial resolution and sampling errors (i.e., estimating round objects spatially with rectilinear voxels). Application of a PVE method typically depends upon the available data and software and has most extensively been studied for .sup.18F-FDG tumor imaging with SUV and/or volume as the primary readout. In this study of [.sup.68Ga]MLN6907, PVE correction was evaluated in terms of its ability to improve estimation of tumor antigen density and tumor vascularity via application of a mechanistic pharmacokinetic (PK) model to measured time-activity curves (TACs). Specifically, TACs for liver colorectal cancer metastases of varying tumor volume, antigen density, and vascularity were generated); “Estimating real cell size distribution from cross-section microscopy imaging” (We present an algorithm, Estimate Tissue Cell Size/Type Distribution (EstiTiCS), for the adjustment of the underestimation of the number of small cells and the size of measured cells while accounting for the section thickness independent of the tissue type. We introduce the sources of bias under different tissue distributions and their effect on the measured values with simulation experiments. We present an algorithm for estimation of tissue cell size distribution (EstiTiCS) from tissue slices, which is able to correct for three types of bias).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHELLE M ENTEZARI HAUSMANN whose telephone number is (571)270-5084. The examiner can normally be reached 10-7 M-F.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Vincent M Rudolph can be reached at (571) 272-8243. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHELLE M ENTEZARI HAUSMANN/Primary Examiner, Art Unit 2671
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