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 .
Response to Amendments
The amendments to the claims, filed on 02/15/2024, have been acknowledged, accepted, and entered. Previously claims 1 – 37 were pending, claim 5 has been cancelled, claims 4, 6, 7, 10, 11, 14, 17, 20, 23, 24, 27, 28, 31, and 34 - 37 have been amended, and now claims 1 – 4 and 6 – 37 are still currently pending.
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.
Claim 27 is 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.
Regarding claim 27, the claim uses the term “the filtered 2D PET-CT slices” in the claim. There is insufficient antecedent basis for this limitation in the claim as it is the first time the term is used and has no previous explanation or structure associated with it. Therefore, the claim is rejected for lack of antecedent basis and for failing to particularly point out and distinctly claim the subject matter of the claimed invention.
Claim Rejections - 35 USC § 102
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 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 1 – 4, 6, 18 – 23 and 37 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ramamurthy; Venkat (US 20060030768 A1; hereinafter simply referred to as Ramamurthy).
Regarding independent claim 1, Ramamurthy teaches:
A system for monitoring treatment of a patient, the system comprising data input and output utilities, memory, and a data processor, and being configured for data communication with an image data provider to receive from the image data provider image data indicative of combined PET-CT scan images including at least one first pre-treatment full body scan image of a patient and at least one second post-treatment full body scan image of the patient (See ¶ 11 – 13, 15, 26, 28, 29 and 54 - 55 and figure 1, 8, and 9 wherein a system comprises a processor and memory and input and output utilities being the received PET-CT data as input and the output being, output 155, as seen in figure 1, wherein the image data received from the PET-CT scan images includes pre treatment/therapy and post treatment/therapy, wherein using the examiner’s broadest reasonable interpretation of the phrase full body, the prior art teaches of the full upper body from head to hip being scanned (See Figures 8 and 9) which encompasses all vital body parts that require scanning).
an identifier utility configured to process the image data to identify matching first and second 2D regions in, respectively, first 2D slices forming the first pre-treatment full body scan image and second 2D slices forming the second post-treatment full body scan image (See ¶ 72, 85, 15, 16, 49, wherein matching/registration of the image data is done between the 2D slices forming the pre and post treatment/therapy body scan images)
locate at least one pair of corresponding first and second 3D regions in the first and second full body scan images, respectively (See ¶ 58, 61, 86 and 18 – 20 wherein 3D/VOI regions such as organs and other anatomical structures are found in the first and second full body scans (pre and post therapy time series) and tracked)
an analyzer configured and operable to analyze each of said at least one pair of the first and second 3D regions and determine a change in at least one parameter of interest in the first and second 3D regions, and generate output data indicative of said change (See ¶ 86, 87, 89, 19, and 20 wherein VOI(Volume of interest)/3D region is analyzed and changes are tracked over time wherein parameters of interest include change in volume, and wherein the output is generated and displayed).
Regarding dependent claim 2, Ramamurthy teaches:
represent each slice in a first set of the 2D slices forming the first full body scan image and each slice in a second set of the 2D slices forming the second full body scan image by respective first 2D logical image and second 2D logical image, the first and second 2D logical images comprising first Coronal and first Sagittal pre-treatment images, and second Coronal and second Sagittal post-treatment images. (See ¶ 24, 50, 78, 79, 23, and 62 wherein the first and second full body scan images are represented in 2D slices wherein the first and second 2D logical images are represented by the sagittal and coronal image views wherein).
Regarding dependent claim 3, Ramamurthy teaches:
a data transformation utility configured to transform 3D data indicative of each of said at least one first full body scan image and each of said at least one second full body scan image into respective first and second pairs of 2D logical images, the 2D logical images of the first pair corresponding to a first pre-treatment Coronal image and a first pre- treatment Sagittal image of the patient's body and the 2D logical images of the second pair corresponding to a second post-treatment Coronal image and a second post-treatment Sagittal image of the patient's body; (See ¶ 23, 24, 57, 58, 62, 78, 79, wherein the 3D full body scan image data is represented in 2D logical images being pre therapy/treatment Sagittal and Coronal images and post therapy/treatment Sagittal and Coronal images)
a match finding utility configured to process data indicative of the first and second pairs of the 2D logical images and define one or more pairs of matching 2D regions in said first and second pairs of the 2D logical images, each pair of the matching 2D regions being defined by first 2D regions in the first Coronal and Sagittal images matching with respective second 2D regions in the second Coronal and Sagittal images; (See ¶ 72, 85, 15, 16, 24, 58, 79 49, wherein matching/registration of the image data is done between the 2D Sagittal and Coronal slices forming the pre and post treatment/therapy body scan images)
and a region defining utility configured to analyze each of said one or more pairs of the matching 2D regions over the first and second full-body scan images, and define and locate a corresponding pair of matching first and second 3D regions in the first and second full body scan images, such that the first 3D region in the first full body scan image corresponds to the first 2D regions in the first Coronal and first Sagittal images, and the second 3D region in the second full body scan image corresponds to the second 2D regions in the second Coronal and Sagittal images, thereby determining data about said one or more 3D regions to be analyzed to identify changes between pre-treatment and post-treatment. (See ¶ 86, 87, 89, 72, 85, 15, 16, 24, 58, 79 wherein the VOI/3D regions are analyzed to determine changes between pre and post treatment/therapy wherein the respective VOI/3D images of the pre and post therapy body scans correspond to their respective 2D regions in the Coronal and Sagittal images).
Regarding dependent claim 4, Ramamurthy teaches:
Determine a solid matching matrix between the one or more 3D regions pre-treatment to corresponding one or more 3D regions post- treatment, thereby enabling to identify the changes in one or more parameters of the matching regions; (See ¶ 58, 16, 19, 20 wherein 3D image data (VOI/3Dregions) undergo registration, wherein the registration necessarily comprises the use of a matrix (solid matching matrix) and wherein the identifying changes in or more parameters of the matching regions is done such as change in volume or diameter)
the region defining utility is configured to determine a solid matching matrix between the one or more 3D regions pre-treatment to corresponding one or more 3D regions post-treatment, thereby enabling to identify data indicative of one or more new regions that emerged and data indicative of old regions that disappeared, as a result of said treatment. (See ¶ 58, 16, 6, 18, 48, 19, 20 wherein 3D image data (VOI/3Dregions) undergo registration, wherein the registration necessarily comprises the use of a matrix (solid matching matrix) and wherein the VOI is a lesion, tumor, or cancer and the comparison of parameters such as area, volume, number of pixels and deviation of the VOI in the post and pre therapy/treatment images would give indication of whether a new region had emerged or if old regions had disappeared due to treatment/therapy.)
Regarding dependent claim 6, Ramamurthy teaches:
One or more parameters comprise at least volume. (See ¶ 19 and 20 wherein on of the parameters is volume)
Regarding dependent claim 18, claim 18 is a method claim corresponding to claim 1. Please see the discussion of claim 1 above.
Regarding dependent claim 19, Ramamurthy teaches:
Output data comprises data indicative of one or more new regions that emerged and data indicative of old regions that disappeared. (See ¶ 58, 16, 6, 18, 48, 19, 20 wherein the VOI is a lesion, tumor, or cancer and the comparison of parameters such as area, volume, number of pixels and deviation of the VOI in the post and pre therapy/treatment images would give indication of whether a new region had emerged or if old regions had disappeared due to treatment/therapy.)
Regarding dependent claim 20, claim 20 is a method claim corresponding to claim 2. Please see the discussion of claim 2 above.
Regarding dependent claim 21, claim 21 is a method claim corresponding to claim 3. Please see the discussion of claim 3 above.
Regarding dependent claim 22, Ramamurthy teaches:
Determining a solid matching matrix between the one or more pre-treatment 3D regions and corresponding one or more post-treatment 3D regions post-treatment, thereby enabling to identify the changes in one or more parameters of the matching regions. (See ¶ 58, 16, 19, 20 wherein 3D image data (VOI/3Dregions) undergo registration, wherein the registration necessarily comprises the use of a matrix (solid matching matrix) and wherein the identifying changes in or more parameters of the matching regions is done such as change in volume or diameter).
Regarding dependent claim 23, claim 23 is a method claim corresponding to claim 6. Please see the discussion of claim 6 above.
Regarding dependent claim 37, Ramamurthy teaches:
Automatically generating a report of all findings in the post-treatment scans and their difference from the pre-treatment. (See ¶ 88, 80, 21 wherein a report is generated for differences/comparisons of VOIs of different timepoints (post and pre treatment/therapy)).
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 of this title, 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.
Claim(s) 35 and 36 are rejected under 35 U.S.C. 103 as being unpatentable over Ramamurthy; Venkat (US 20060030768 A1; hereinafter simply referred to as Ramamurthy) in view of Madabhushi; Anant (US 20180247410 A1; hereinafter simply referred to as Madabhushi)
Regarding dependent claim 35, Ramamurthy teaches:
Receiving the combined PET-CT scan image and generating and presenting on a user interface corresponding full-body 3D image and 2D images of the PET-CT scan (See ¶ 88, 80, 21 wherein the PET-CT image data is presented on a user interface corresponding to 3D and 2D images of the PET-CT scan)
Ramamurthy does not explicitly disclose the suspicious regions are automatically marked.
However, Madabhushi teaches of the suspicious regions are automatically marked. (See ¶ 17 wherein suspicious regions (nodules) are automatically annotated/marked).
As taught by Madabhushi the annotation of a suspicious region includes segmenting the region from the background of the image therefore making it easier to see the now segmented and annotated region. (See ¶ 17 wherein the annotation of a suspicious region includes segmentation of the region from the background image making it easier to distinguish the region). As both the teachings of Ramamurthy and Madabhushi deal with the technical field of image processing of PET-CT images; it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Ramamurthy and Madabhushi to teach of automatically marking suspicious regions in order for the suspicious regions to be easily distinguished in the image.
Regarding dependent claim 36, Ramamurthy teaches:
Receiving the combined full body pre-treatment and post-treatment PET-CT scans and generating and presenting on user interface corresponding full-body 3D and 2D images of the post-treatment PET-CT scan presenting changes from the pre-treatment scan in volume (See ¶ 80, 21, 19, 88 wherein the pre and post PET-CT scan 3D and 2D image data is presented showing quantified (volume) changes from the pre treatment/therapy).
Ramamurthy does not disclose the presentation being in the form of a heat map.
However, Madabhushi teaches of a heat map being used to present pre and post treatment PET-CT image data. (See ¶ 26, 27 and 52 wherein a heatmap is used to present pre and post treatment PET-CT image data).
As taught by Madabhushi the use of a heatmap for presenting pre and post treatment PET-CT data allows for analysis of the image data using a visual representation. (See ¶ 26 and figure 2 wherein the heatmap provides a visual representation of the image data that be further analyzed). As both the teachings of Ramamurthy and Madabhushi deal with the technical field of image processing using PET-CT images; it would have been obvious to one ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Ramamurthy with Madabhushi in order for a heatmap to be used to represent the pre and post PET-CT image data in a visual manner.
Allowable Subject Matter
Claims 7 - 17, 24 - 26, 28 - 34 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.
The following is a statement of reasons for the indications of allowable subject matter:
Regarding clams 7 and 24, the reason of allowable subject matter is that the prior art fails to teach or reasonably suggest the limitations of claims 1 and 20 respectively, further comprising pre-processing raw data indicative of said first and second full body scan images to define said 3D data for the transformation, said pre-processing comprising: normalizing data corresponding to each of the first and second full body scan images to a predetermined scale thereby obtaining respective first and second normalized full body scan images; and applying spatial and thresholding filtering to each of said first and second full body normalized scan images and providing corresponding first and second sets of filtered 2D PET slices forming said first and second full body scan images, respectively.
Regarding claims 11 and 28, the reason for allowable subject matter is that the prior art fails to teach of reasonably suggest the limitations of claims 3 and 21 respectively, further comprising performing registration of each of the 2D logical images of the first pair in X- and Y axes to correspond to shifts of the patient's body between scans during imaging.
Regarding claims 14 and 31, the reason for allowable subject matter is that the prior art fails to teach of reasonably suggest the limitations of claims 3 and 21, further comprising representing each of the 2D regions in 3D space and in 2D space by performing 2D Cross-Correlation, to determine a distance, R, by which the first pre- treatment image is to be moved for matching the second post-treatment image, for each of the Coronal and Sagittal 2D images.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See attached PTO-892.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALEJANDRO HERNANDEZ whose telephone number is (703)756-1876. The examiner can normally be reached M-F 8 am - 5 pm ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, John M Villecco can be reached at (571) 272-7319. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ALEJANDRO HERNANDEZ/Examiner, Art Unit 2661
/AARON W CARTER/Primary Examiner, Art Unit 2661