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 .
Comments
The Preliminary Amendment filed on September 11, 2023 has been entered and made of record.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code (See Paragraph [0236] line 12). Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description:
Reference Numerals “508”, “510”, “528” and “540” shown in Figure 5;
Reference Numerals “602” and “604” shown in Figure 6A;
Reference Numerals “622” and “624” shown in Figure 6B;
Reference Numerals “642” and “644” shown in Figure 6C; and
Reference Numeral “860” shown in Figure 8.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference character “1460” has been used to designate both Audio Codec and Cellular Telephone in Figure 14. Cellular Telephone should be labeled 1480 according to Paragraph [0281] line 3.
Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 36-40, 43, 44 and 48 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Richter et al. (U.S. Pub. No. 2020/0245960).
Re claim 36: Richter et al. disclose a method for analyzing a plurality of medical images of a subject (See for example, “methods that provide for automated analysis of three-dimensional (3D) medical images of a subject”, Abstract; and “automated segmentation, hotspot detection, and index value calculation for detecting cancer and tracking cancer progression and/or response to treatment over time”, Paragraph [0332]; see also claim 13), the method comprising:
(a) receiving and/or accessing, by a processor of a computing device (i.e., “The computing device 1800 includes a processor 1802”, Paragraph [0382]), the plurality of medical images of the subject (i.e., “a 3D functional image (e.g., a PET image) is received 528”, Paragraph [0240]) and obtaining, by the processor, a plurality of 3D hotspot maps, each corresponding to a particular medical image and identifying one or more hotspots within the particular medical image (i.e., “identify, for each target VOI, a corresponding 3D volume in the 3D functional image 530. The identified 3D volumes are then used to detect 532, within the 3D functional image, one or more hotspots corresponding to localized regions of high intensity relative to their surroundings. In particular, one or more specific 3D volumes may correspond to specific tissue regions where cancerous lesions may form”, paragraph [0240]);
(b) for each particular one of the plurality of medical images, determining, by the processor, using a machine learning module, a corresponding 3D anatomical segmentation map that identifies a set of organ regions within the particular medical image, thereby generating a plurality of 3D anatomical segmentation maps (i.e., “a machine learning module receives a 3D anatomical image (e.g., a full body image) as input 502, and identifies, for each of a plurality of target tissue region, a target volume comprising a graphical representation of the target tissue region within the 3D anatomical image 504. The target volumes are stitched together 506 to form a segmentation map 510 that comprises a plurality of segmentation masks 512, with each segmentation mask representing an identified target volume”, Paragraph [0208]; and “target VOIs corresponding to organs”, Paragraph [0220]);
(c) determining, by the processor, using (i) the plurality of 3D hotspot maps and (ii) the plurality of 3D anatomical segmentation maps, an identification of one or more lesion correspondences (i.e., “for a particular detected hotspot, a hotpot[sic] index value that can be used to infer and/or quantify uptake of radiopharmaceutical within the lesion that the detected hotspot represents”, Paragraph [0295]), each identifying two or more corresponding hotspots within different medical images and determined to represent a same underlying physical lesion within the subject (i.e., “the computed index values can be compared with each other for a particular patient”, Paragraph [0295]); and
(d) determining, by the processor, based on the plurality of 3D hotspot maps and the identification of the one or more lesion correspondences, values of one or more metrics (See for example, Paragraphs [0295] and [0298]).
Re claim 37: Richter et al. disclose wherein the plurality of medical images comprise one or more anatomical images (i.e., “3D anatomical image”, Paragraph [0240]).
Re claim 38: Richter et al. disclose wherein the plurality of medical images comprise one or more nuclear medicine images (i.e., “In certain embodiments, 3D functional images are nuclear medicine images”, Paragraph [0334]).
Re claim 39: Richter et al. disclose wherein the plurality of medical images comprise one or more composite images, each comprising an anatomical and a nuclear medicine pair (i.e., “a 3D anatomical image is received 522 ... a 3D functional image (e.g., a PET image) is received 528 and the segmentation map is transferred to the 3D functional image to identify, for each target VOI, a corresponding 3D volume in the 3D functional image 530”, Paragraph [0240]).
Re claim 40: Richter et al. disclose wherein the plurality of medical images are or comprises a time series of medical images, each medical image of the time series associated with and having been acquired at a different particular time (i.e., “The computed hotspot index can be related to clinical endpoints, including survival rate of a patient and to determine treatment strategy. When computed for multiple images, collected at different time points, the computed index values can be compared with each other for a particular patient, and the change in index used to evaluate efficacy of a treatment”, Paragraph [0295]).
Re claim 43: Richter et al. disclose wherein step (a) comprises generating each hotspot map by segmenting at least a portion of the corresponding medical image (i.e., “Segmentation masks representing the identified target VOIs are mapped to the PET image to identify corresponding 3D volumes within the PET image”, Paragraph [0297]).
Re claim 44: Richter et al. disclose wherein each hotspot map comprises, for each of at least a portion of the hotspots identified therein, one or more labels identifying one or more assigned anatomical regions and/or lesion sub-types (i.e., Paragraph [0217] and [0310]).
Re claim 48: Richter et al. disclose determining values of one or more prognostic metrics indicative of disease state/progression and/or treatment (i.e., “Risk indices that correlate with patient overall survival and other prognostic metrics indicative of disease state, progression, treatment efficacy, and the like, can be computed based on automated analysis of intensity variations in whole-body scans obtained following administration of 99mTc MDP to a patient”, Paragraph [0336]).
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.
Claims 35 and 47 are rejected under 35 U.S.C. 103 as being unpatentable over Richter et al. (U.S. Pub. No. 2020/0245960) in view of Carmi (U.S. Pub. No. 2022/0058804).
As to claim 35, Richter et al. teaches a method for automated analysis of a time series of medical images of a subject (See for example, “methods that provide for automated analysis of three-dimensional (3D) medical images of a subject”, Abstract; and “automated segmentation, hotspot detection, and index value calculation for detecting cancer and tracking cancer progression and/or response to treatment over time”, Paragraph [0332]), the method comprising:
(a) receiving and/or accessing, by a processor of a computing device (i.e., “The computing device 1800 includes a processor 1802”, Paragraph [0382]), the time series of medical images of the subject (See for example, “a 3D functional image (e.g., a PET image) is received 528 and the segmentation map is transferred to the 3D functional image to identify, for each target VOI, a corresponding 3D volume in the 3D functional image 530”, Paragraph [0240]); and
(b) identifying, by the processor, a plurality of hotspots within each of the medical images (i.e., “The identified 3D volumes are then used to detect 532, within the 3D functional image, one or more hotspots corresponding to localized regions of high intensity relative to their surroundings”, Paragraph [0240]).
However, Richter et al. does not explicitly disclose determining, by the processor, one, two, or all three of (i), (ii), and (iii) as follows: (i) a change in the number of identified lesions (ii) a change in an overall volume of identified lesions, and (iii) a change in PSMA weighted total volume.
Carmi teaches determining, by a processor (i.e., “special purpose processors 22”, Paragraph [0029]), one, two, or all three of (i), (ii), and (iii) as follows: (i) a change in the number of identified lesions (ii) a change in an overall volume of identified lesions, and (iii) a change in PSMA weighted total volume (See for example, “The change of the lesion over time may be assessed based on measured lesion characteristics in successive images, such as maximum and mean image intensity, lesion size (segmented volume), morphological structures, and lesion texture”, Paragraph [0030]).
Carmi is analogous art because it is from the same field of digital image processing for analyzing medical images.
Before the effective filing date of the claimed invention, it would have been obvious to a person of ordinary skill in the art to modify Richter et al. by incorporating the determining of one, two, or all three of (i), (ii), and (iii) as follows: (i) a change in the number of identified lesions (ii) a change in an overall volume of identified lesions, and (iii) a change in PSMA weighted total volume, as taught by Carmi.
The suggestion/motivation for doing so would have been to assess patient response to a treatment or therapy.
Therefore, it would have been obvious to combine Carmi with Richter et al. to obtain the invention as specified in claim 35.
As to claim 47, Richter et al. does not explicitly disclose wherein step (d) comprises determining one, two, or all three of (i), (ii), and (iii) as follows: (i) a change in the number of identified lesions (ii) a change in an overall volume of identified lesions, and (iii) a change in PSMA.
Carmi teaches determining one, two, or all three of (i), (ii), and (iii) as follows: (i) a change in the number of identified lesions (ii) a change in an overall volume of identified lesions, and (iii) a change in PSMA (See for example, “The change of the lesion over time may be assessed based on measured lesion characteristics in successive images, such as maximum and mean image intensity, lesion size (segmented volume), morphological structures, and lesion texture”, Paragraph [0030]).
Therefore, in view of Carmi, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Richter et al. by incorporating the determining of one, two, or all three of (i), (ii), and (iii) as follows: (i) a change in the number of identified lesions (ii) a change in an overall volume of identified lesions, and (iii) a change in PSMA, as taught by Carmi, in order to assess patient response to a treatment or therapy.
Claims 41 and 42 are rejected under 35 U.S.C. 103 as being unpatentable over Richter et al. in view of Rousso et al. (U.S. Pub. No. 2007/0265230). The teachings of Richter et al. have been discussed above.
As to claim 41, Richter et al. teaches where the time series of medical images comprises a second medical image acquired after administering the particular therapeutic agent to the subject (i.e., “The automated image analysis procedures are used for evaluated cancer status of patients imaged via PET/CT scanning after being administered the radiopharmaceutical 18F-DCFPyL”, Paragraph [0320]).
However, Richter et al. does not explicitly disclose where the time series of medical images comprises a first medical image acquired before administering a particular therapeutic agent to the subject.
Rousso et al. teaches a time series of medical images that comprises a first medical image acquired before administering a particular therapeutic agent to the subject (See for example, “For some applications, functional imaging step 156 is performed both before and after applying the therapy at step 152”, Paragraph [0230]).
Rousso et al. is analogous art because it is from the same field of digital image processing for analyzing medical images.
Before the effective filing date of the claimed invention, it would have been obvious to a person of ordinary skill in the art to modify Richter et al. by incorporating the time series of medical images comprises a first medical image acquired before administering a particular therapeutic agent to the subject, as taught by Rousso et al.
The suggestion/motivation for doing so would have been to assess an effect of the therapy.
Therefore, it would have been obvious to combine Rousso et al. with Richter et al. to obtain the invention as specified in claim 41.
As to claim 42, Richter et al. teaches classifying the subject as a responder and/or a non-responder to the particular therapeutic agent based on the values of one or more metrics determined at step (d) (See for example, Paragraphs [0329] and [0332]).
Allowable Subject Matter
Claims 45, 46 and 49-51 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claims 52-54 and 59-63 are allowed.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOSE M TORRES whose telephone number is (571)270-1356. The examiner can normally be reached Monday thru Friday; 10:00 AM to 6:00 PM EST.
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/JOSE M TORRES/Examiner, Art Unit 2664 09/05/2025