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 .
Election/Restrictions
As a result of the Petition Decision, mailed 12/11/2025, the restriction from, mailed 02/13/2025, has been withdrawn. Under examination are claims 1-20. Because the Applicant did not receive an examination of all the claims, the previous Non-Final, mailed 08/04/2025, is withdrawn and a new action on the merits is herein.
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(s) 6 is/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.
Regarding Claim 6
Claim 6 is directed to determining the target anatomy from a plurality of potential anatomies. The Specification discloses that the target anatomy can be the brain, region of the brain, sternum or other specified organ or region (Para 0040). The claim interpretation based on the Disclosure of the Applicant is that there is a list of potential target anatomies such as lung, brain and liver. From the cited list, the target is determined/selected from the list based on the predictability of radiotracer uptake. In review we have a list and a way to determine a selected target from the list. Then the claim limits further lists the determination to be the brain. The claim does not make sense as to why one would determine a target anatomy based on a calculation but essentially disregard the determination and determine the brain from the list. The claim cannot be interpreted as here is this list of potential target anatomies and it is further limited to include the brain in the list. The claim interpretation is to determine the brain to be the target anatomy. For the purpose of examination, the Examiner is interpreting the claim limitation that the brain is the target anatomy.
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.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Watson et al. (U.S. Patent Application 2005/0129170 A1) and further in view of Vosinak et al. (U.S. Patent Application 2012/0271840 A1).
Claim 1: Watson teaches –
A method [method for improving clinical data quality in Positron Emission Tomography] (Abstract), comprising:
generating one or more calibration [pre-scanned] [Calibration is performed] (Para 0084) images [image][sinogram(s)] (Para 0093) of a region of interest (ROI) of a target anatomy [a region of interest in an image is determined…and used to estimate a local SNR(Dinj)] (Para 0093) of a patient injected with a radiotracer with the patient [a patient is injected with radiopharmaceutical] (Para 0084) positioned within a positron emission tomography (PET) system [Positron Emission Tomography (PET)] (Abstract) [with a small calibration dose given initially. After a short uptake, the patient is pre-scanned for a short period timed only long enough to determine T. S, and R] (Para 0084);
measuring a radiotracer activity concentration [where A represents either a total activity, or a mean activity concentration per mass or volume] (Para 0081) of the region of interest (ROI) of the target anatomy of the patient [a region of interest in an image is determined…and used to estimate a local SNR(Dinj)] (Para 0093) from the one or more calibration [pre-scanned] [Calibration is performed] (Para 0084) images [image][sinogram(s)] (Para 0093);
determining a measure of radiotracer uptake [determined…uptake period] (Para 0082) of the ROI of the target anatomy of the patient using the measured radiotracer activity concentration [function of any quantity related to activity] (Para 0082)
[SNR is determined as a function of any quantity related to activity, such as uptake period; excretion fraction; and dose fractionation, that is, a dose administered in several partial doses] (Para 0082);
comparing [correlated] (Para 0090) the determined measure of radiotracer [peak SNR] (Para 0089) uptake to a specified reference uptake [the optimal dose is known for each scan completed and is statistically correlated via the database with important patient characteristics] (Para 0090) [patient characteristics such as…peak SNR] (Para 0089);
Examiner’s Note: It is understood, from paragraphs 0080-0089, that the optimal or peak SNR is a function of radiotracer uptake period and is used to determine the optimal dosage. The peak SNR of the database is the specified reference uptake.
modifying the one or more initial scan parameters [Once SNR(Dinj)is known, it can be used to determine how to adjust injected dose, as well as other scan parameters] (Para 0016); and
Watson fails to specifically state that the patient is still positioned within the PET system. However, given the disclosure of Watson, it would have been obvious to one of ordinary skill in the art to have the patient still positioned within the PET system. Watson teaches –
wherein the patient is still positioned within the PET system when the diagnostic image data is acquired [the dose may be fractionated, with a small calibration dose given initially. After a short uptake, the patient is pre-scanned for a short period timed only long enough to determine T, S, and R. The duration of this pre-scan is as short as a few seconds. From T, S, and R, an optimal dose is determined and the remainder injected] (Para 0084).
Examiner’s Note: Since the calibration scan is only a few seconds, it is understood that the patient remains within the PET as the optimal dose is determined and the remainder is injected. The process of disconnecting the patient from the injector after pre-scan, removing the patient from the PET system, to then put the patient back and re-connect the injector is illogical and impractical. Barring a medical emergency, PET operators would obviously leave the patient within the PET system to resume scanning after the pre-scan for efficiency and convenience.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Watson to have the patient still positioned within the PET system given the few seconds that the calibration imaging takes and the need to resume injecting the optimal dose of the radiotracer (Para 0084)
Watson fails to teach the steps of outputting a notification, modifying in response to user input and acquiring image data according to modified scan parameters. However, Vosniak teaches –
outputting a notification to a user [The differences may be displayed in a chart, such as the chart 400 (shown in FIG. 5)] (Para 0024),
wherein the notification comprises one or more recommendations for modification to one or more initial scan parameters based on comparison between the determined measure of radiotracer uptake and the specified reference uptake [to provide notification of differences between the stored scan protocol and the current scan protocol and/or generate a recommended scan protocol] (Para 0019 and Figure 5);
modifying the one or more initial scan parameters in response to user input [the operator may input a new scan protocol based on the stored scan protocol 118 and the current scan protocol 114. The new scan protocol may include modifications to the stored scan protocol 118 and/or the current scan protocol 114] (Para 0024); and
acquiring diagnostic image data of the patient according to the one or more modified scan parameters [imaging system may utilize the recommended scan protocol or a user selected scan protocol to acquire scan data of an object] (Para 0019) thereby providing improved or more conclusive analysis of the images and improved image quality (Para 0003) in a time efficient manner and better accuracy (Para 0004)
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 method of Watson to include the steps of outputting a notification, modifying in response to user input and acquiring image data according to modified scan parameters as taught by Vosniak in order to provide improved or more conclusive analysis of the images and improved image quality (Para 0003) in a time efficient manner and better accuracy (Para 0004).
Claim 2/1: Watson teaches wherein modification of the one or more initial scan parameters comprises corrective action to the one or more initial scan parameters [Once SNR(Dinj)is known, it can be used to determine how to adjust injected dose, as well as other scan parameters] (Para 0016), wherein the corrective action includes at least one of adjusting scan duration [The appropriate adjustments to scan duration and injected dose are then determined to best utilize count rate performance] (Para 0119).
Claim 3/1: Watson teaches further comprising obtaining the one or more
initial scan parameters [It also depends on various characteristics of the scanner itself, including its shielding, sensitivity, dead time per detected event, and its energy and time discrimination capabilities] (Para 0013) and one or more patient parameters, wherein the one or more patient parameters include patient sex and age [patient characteristics such as weight, body mass index (BMI), sex, disease, diabetes state] (Para 0089).
Claim 4/3/1: Watson teaches wherein the one or more initial scan parameters include scan duration [The appropriate adjustments to scan duration and injected dose are then determined to best utilize count rate performance] (Para 0119).
Examiner’s Note: Only one scan parameter of the one or more is required by the claim limitation.
Claim 5/3/1: Watson teaches wherein the specified reference uptake [peak SNR] (Para 0089) corresponds to the one or more patient parameters [the optimal dose is known for each scan completed and is statistically correlated via the database with important patient characteristics such as weight] (Para 0090).
Examiner’s Note: It is understood, from paragraphs 0080-0089, that the optimal or peak SNR is a function of radiotracer uptake period and is used to determine the optimal dosage. The peak SNR of the database is the specified reference uptake.
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Watson et al. (U.S. Patent Application 2005/0129170 A1) and Vosinak et al. (U.S. Patent Application 2012/0271840 A1) as applied to Claim 1 above, and further in view of Sawyer et al. (U.S. Patent Application 2007/0014454 A1).
Claim 6/1: Watson and Vosinak fails to teach wherein the target anatomy is determined from a plurality of potential target anatomies based on predictability of radiotracer uptake, and wherein the target anatomy is determined to be a brain of the patient. However, Sawyer teaches wherein the target anatomy is a region of a brain [imaging techniques for brain and other neoplasms] (Para 0003; Para 0081 and pending 35 USC § 112 rejection above) in order to produce diagnostic, outcome, testing and therapeutic information about the disease and disease treatment for the brain (Para 0015)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Watson and Vosniak to wherein the target anatomy is the brain as taught by Sawyer in order to produce diagnostic, outcome, testing and therapeutic information about the disease and disease treatment for the brain (Para 0015)
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Watson et al. (U.S. Patent Application 2005/0129170 A1) and Vosinak et al. (U.S. Patent Application 2012/0271840 A1) as applied to Claim 1 above, and further in view of Vosinak et al. (U.S. Patent Application 2013/0131422 A1; referred to herein as Vosinak‘422).
Claim 7/1: Watson teaches wherein the comparing [correlated] (Para 0090) the determined measure of radiotracer uptake to the specified reference uptake comprises determining if the determined measure of radiotracer uptake is within range of the specified reference uptake [the optimal dose is known for each scan completed and is statistically correlated via the database with important patient characteristics] (Para 0090) [patient characteristics such as…peak SNR] (Para 0089);
Examiner’s Note: It is understood, from paragraphs 0080-0089, that the optimal or peak SNR is a function of radiotracer uptake period and is used to determine the optimal dosage. The peak SNR of the database is the specified reference uptake.
Watson and Vosinak fail to teach SUVs specifically. However, Vosinak‘422 teaches wherein the measure of radiotracer uptake and the specified reference uptake are one of standardized uptake values (SUVs) (Figure 3, Element 200 SUV) in order to perform data checking (Para 0053)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Watson and Vosinak to include the SUV of Vosinak‘422 in order to perform data checking (Para 0053).
Claim(s) 8-9, 11-12 & 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Vosinak et al. (U.S. Patent Application 2013/0131422 A1; referred to herein as Vosinak‘422 and as further evidenced by Lockhart et al. “Quantifying and Reducing the Effect of Calibration Error on Variability of PET/CT Standardized Uptake Value Measurements”. The Journal of Nuclear Medicine. Vol. 52, No. 2; February 2011; enclosed herein) and further in view of Vosinak et al. (U.S. Patent Application 2012/0271840 A1).
Examiner’s Note: The prior art reference is not relied on within the rejection herein but used to support the Examiner’s position of what Vosinak is teaching. Vosinak teaches kBq/mL (Figure 3) and Lockhart supports that kBq/mL is the unit of measure for radioactive concentrations (See Page 218, Right Column). Lockhart also provides a higher resolution in Figure 1 which is the same as Figure 4 of Vosinak.
Claim 8: Vosinak‘422 teaches –
A system [system] (Figure 1, Element 100), comprising:
a computing device [host system] [processing unit] [computer] (Figure 1, Element 140, 144 and/or 146), communicatively [network communication] [network] (Figure 1, Element 120) coupled to a positron emission tomography (PET) system [scanner] (Figure 1, Element 140) [PET imaging system] (Para 0026) configured to image a patient [patient] (Figure 1, Element 132), the computing device configured with instructions in non-transitory memory [physical memory element within a processing machine] (Para 0073) that when executed cause the computing device to perform [computer or processor executes a set of instructions that are stored in one or more storage elements, in order to process input data] (Para 0073):
obtain one or more patient parameters of the patient [The user interface 122 may be used to input patient information…may include a patient’s name, sex, age, weight] (Para 0050) and one or more initial scan parameters of the PET system [scanning parameters from an operator via an operator workstation 440 that has an input device] (Para 0062);
obtain one or more images of a target anatomy of the patient with the PET system (See Figure 4, Element 250 & 252);
measure a radiotracer activity concentration [which are a measure of the relative amount of tracer uptake in the patient] (Para 0004) of a region of interest (ROI) (Figure 4, Element 11 & 12) of the target anatomy of the patient [kBq/ml] (Figure 3, Element kBq/ml; known unit of radioactive concentration);
calculate a standard uptake value of a region of interest (ROI) of the target anatomy (Figure 4, Element 11 & 12; where the region of interest of Element 11 is Max SUV 23.6 and the region of interest of 12 is Max SUV of 19.7) within the one or more images the ROI (Figure 4, Element 250 & 252) using the measured radiotracer activity concentration (Figure 3, Element kBq/ml), a decay corrected amount of injected radiotracer (Figure 3, Element decay corrected net activity), and a weight of the patient (Figure 3, Element Patient weight);
Vosinak‘422 fails to teach that specifically the calculated SUV is compared to a reference. However, Vosinak‘422 obviously teaches –
compare the calculated SUV to a specified reference SUV [if the data communicated exceeds a threshold or is not within a range based on a standard for a specific protocol, a warning may be provided] (Para 0053) (Figure 3, Element 200 SUV);
determine if the calculated SUV is within range of the specified reference SUV [if the data communicated exceeds a threshold or is not within a range based on a standard for a specific protocol, a warning may be provided] (Para 0053);
in response to a determination that the calculated SUV is out of range of the specified reference SUV [if the data communicated exceeds a threshold or is not within a range based on a standard for a specific protocol, a warning may be provided] (Para 0053), send a warning [a warning may be provided] (Para 0053);
Vosinak‘422 teaches the comparison and range determination within the data and the data include SUV [the measured and recorded data is performed electronically and automatically stored and communicated, such as to the host system 140] (Para 0035)
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 data comparison and range determination of Vosinak‘422 to include the SUV as taught by Vosinak‘422 since Vosinak‘422 teaches broadly data comparison and range determination to include the narrower SUV in order to perform data checking (Para 0053)
Vosinak‘422 teaches that after a data check to warn the operator (Para 0053). Vosinak‘422 fails to teach corrective action. However, Vosinak teaches –
automatically or semi-automatically modify the one or more initial scan parameters into one or more modified scan parameters [imaging system may utilize the recommended scan protocol or a user selected scan protocol to acquire scan data of an object] (Para 0019); and
obtain diagnostic imaging data with the PET system according to the one or more modified scan parameters [imaging system may utilize the recommended scan protocol or a user selected scan protocol to acquire scan data of an object] (Para 0019) thereby providing improved or more conclusive analysis of the images and improved image quality (Para 0003) in a time efficient manner and better accuracy (Para 0004)
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 system of Vosinak‘422 to include the corrective actions as taught by Vosniak in order to provide improved or more conclusive analysis of the images and improved image quality (Para 0003) in a time efficient manner and better accuracy (Para 0004).
Vosinak‘422 teaches calibration through dose measurements. Vosinak‘422 fails to teach calibration images. However, Vosinak teaches –
calibration images [previous images generated for the patient] (Para 0036) of a target anatomy of the patient [anatomy of interest of a patient] (Para 0020) with the PET system [the previous stored scan protocols 118 are accessed by the rules engine 112 at 220] (Para 0035 and Figure 2, Element 220) thereby providing improved or more conclusive analysis of the images and improved image quality (Para 0003) in a time efficient manner and better accuracy (Para 0004)
Examiner’s Note: The prior art does not specifically name the calibration images as calibration images. However, the prior art uses calibration images in that the previous images of the patient are used in the follow-up scan protocol and thus act as calibration images.
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 system of Vosinak‘422 to include the calibration images as taught by Vosniak in order to provide improved or more conclusive analysis of the images and improved image quality (Para 0003) in a time efficient manner and better accuracy (Para 0004).
Claim 9/8: Vosinak‘422 teaches wherein the computing device [host system] [processing unit] [computer] (Figure 1, Element 140, 144 and/or 146) is further configured with instructions that when executed cause the computing device to output a notification to an operator of the PET system [a warning may be provided] (Para 0053) in response to determination that the calculated SUV is out of range of the specified reference SUV [if the data communicated exceeds a threshold or is not within a range based on a standard for a specific protocol, a warning may be provided] (Para 0053 and See the rejection above for Claim 8),
Vosinak‘422 fails to teach recommendations. However, Vosinak teaches wherein the notification indicates one or more recommendations for modification to the one or more initial scan parameters [to provide notification of differences between the stored scan protocol and the current scan protocol and/or generate a recommended scan protocol] (Para 0019 and Figure 5); and in response to user input, modifying the one or more initial scan parameters into the one or more modified scan parameters [the operator may input a new scan protocol based on the stored scan protocol 118 and the current scan protocol 114. The new scan protocol may include modifications to the stored scan protocol 118 and/or the current scan protocol 114] (Para 0024) thereby providing improved or more conclusive analysis of the images and improved image quality (Para 0003) in a time efficient manner and better accuracy (Para 0004)
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 system of Vosinak‘422 to include the recommendations of Vosinak thereby providing improved or more conclusive analysis of the images and improved image quality (Para 0003) in a time efficient manner and better accuracy (Para 0004)
Claim 11/8: Vosinak‘422 teaches in response to determination that the calculated SUV is within range of the specified reference SUV [if the data communicated exceeds a threshold or is not within a range based on a standard for a specific protocol, a warning may be provided] (Para 0053 and See the rejection above for Claim 8)
Vosinak teaches wherein the computing device is further configured with instructions that when executed cause the computing device to automatically initiate acquisition of diagnostic imaging data according to the one or more initial scan parameters [imaging system may utilize the recommended scan protocol or a user selected scan protocol to acquire scan data of an object] (Para 0019) thereby providing improved or more conclusive analysis of the images and improved image quality (Para 0003) in a time efficient manner and better accuracy (Para 0004)
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 system of Vosinak‘422 to include the automatically initiate acquisition of diagnostic images as taught by Vosniak in order to provide improved or more conclusive analysis of the images and improved image quality (Para 0003) in a time efficient manner and better accuracy (Para 0004).
Claim 12/11/8: Vosinak‘422 teaches wherein the computing device is further configured with instructions that when executed cause the computing device to reconstruct the diagnostic imaging data into one or more images [the host system 140 may include an image reconstruction system] (Para 0027), save the one or more images to memory [the image data may be stored in a memory device that is located in the data acquisition processor 560] (Para 0069), and output the one or more images for display on a display device communicatively coupled to the computing device [to instruct a processing unit 146 to display on a display 147 a reconstructed image data on an integrated display and/or send the acquired raw data to the storage device 118] (Para 0030).
Claim 15/8: Vosinak‘422 teaches wherein the specified reference SUV corresponds to the one or more patient parameters (Figure 3, Element 200 SUV; Para 0053 and See the rejection above for Claim 8) and the one or more patient parameters comprise patient age and patient sex [the patient information may include a patient's name, sex, age, weight and the like] (Para 0050) and wherein the specified reference SUV (Figure 3, Element 200 SUV; Para 0053 and See the rejection above for Claim 8) is stored in memory of the computing device [automatically extract measurement data, store that data in some location (e.g., a remote or integrated storage device) and communicate the data to a host system] (Para 0025).
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Vosinak et al. (U.S. Patent Application 2013/0131422 A1; referred to herein as Vosinak‘422 and as further evidenced by Lockhart et al.; cited above) and Vosinak et al. (U.S. Patent Application 2012/0271840 A1) as applied to Claim 8 above, and further in view of Watson et al. (U.S. Patent Application 2005/0129170 A1).
Claim 10/9/8: Vosinak‘422 and Vosinak fail to teach corrective action being scan duration and after patient has been injected taking calibration and diagnostic images. However, Watson teaches wherein the one or more calibration images of a target anatomy of the patient are obtained after a patient has been injected with a radiotracer [a patient is injected with radiopharmaceutical] (Para 0084) and the diagnostic imaging data is obtained with the PET while the radiotracer is actively being taken up by the patient [with a small calibration dose given initially. After a short uptake, the patient is pre-scanned for a short period timed only long enough to determine T. S, and R] (Para 0084). Watson teaches wherein modifying the one or more initial scan parameters [Once SNR(Dinj)is known, it can be used to determine how to adjust injected dose, as well as other scan parameters] (Para 0016) comprises changing scan duration of the PET system [imaging system may utilize the recommended scan protocol or a user selected scan protocol to acquire scan data of an object] (Para 0019) in order to improve the quality of clinical data in PET (Para 0004)
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 system of Vosinak‘422 and Vosinak to include the corrective action and injection process as taught by Watson in order to improve the quality of clinical data in PET (Para 0004).
Claim(s) 13-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Vosinak et al. (U.S. Patent Application 2013/0131422 A1; referred to herein as Vosinak‘422) and Vosinak et al. (U.S. Patent Application 2012/0271840 A1) as applied to Claim 8 above, and further in view of Sawyer et al. (U.S. Patent Application 2007/0014454 A1).
Claim 13/8: Vosniak and Vosniak‘422 fail to specifically teach how the SUV is calculated. However, Sawyer teaches wherein the calculated SUV is calculated based on an ROI specific SUV of the target anatomy [Sub-volume 1 isonumeric image …Peak intensity value (SUV) Elevation of sub-volume 1 (SUV)] (TABLE 1-continued) in order to identify a particular sub-volume, before therapy is initiated, that is unlikely to respond fully to radiation therapy and adjust therapy to the specific sub-volume (Para 0077) in order to improve patient outcomes
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Vosniak and Vosniak‘422 to wherein the target anatomy is the brain and automatically selected as taught by Sawyer in order to identify a particular sub-volume, before therapy is initiated, that is unlikely to respond fully to radiation therapy and adjust therapy to the specific sub-volume (Para 0077) in order to improve patient outcomes.
Claim 14/8: Vosniak teaches real time operation of the system [real-time operation] (Para 0042). Vosniak and Vosniak‘422 fail to teach wherein the target anatomy is a region of the brain and the selection is based on weighting factors and medical record data. However, Sawyer teaches wherein the target anatomy is a region of a brain [imaging techniques for brain and other neoplasms] (Para 0003 and Para 0081) and wherein the target anatomy is automatically selected [a contour particularly likely to contain cancer is automatically selected and displayed] (Para 0071) based on stored weighting factors [an entire tumor or other region of interest, along with sub-regions of the tumor or region of interest, can be represented by a set of numbers] (Para 0038) [isonumeric image enables a long list of tumor parameters to be calculated and stored] (Para 007) and medical record data [Performance status values weight and other vital signs Trend data for weight and other vital signs] (Para 0036) in order to use information as such as test results and patient information along with the medical images of the tumor for the system to produce diagnostic, outcome, testing and therapeutic information that uses the latest knowledge about the disease and disease treatment (Para 0015)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Vosniak and Vosniak‘422 to wherein the target anatomy is the brain and automatically selected as taught by Sawyer in order to in order to use information as such as test results and patient information along with the medical images of the tumor for the system to produce diagnostic, outcome, testing and therapeutic information that uses the latest knowledge about the disease and disease treatment (Para 0015).
Claim(s) 16-17 & 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Watson et al. (U.S. Patent Application 2005/0129170 A1) and further in view of Vosinak et al. (U.S. Patent Application 2012/0271840 A1).
Claim 16: Watson teaches –
A method for a positron emission tomography (PET) system sanity check [method for improving clinical data quality in Positron Emission Tomography] (Abstract), comprising:
obtaining a calibration [pre-scanned] [Calibration is performed] (Para 0084) image [image][sinogram(s)] (Para 0093) of a target anatomy of a patient [a region of interest in an image is determined…and used to estimate a local SNR(Dinj)] (Para 0093),
measuring, from the calibration image, a radiotracer activity concentration [where A represents either a total activity, or a mean activity concentration per mass or volume] (Para 0081) of a region of interest (ROI) of the target anatomy of the patient [a region of interest in an image is determined…and used to estimate a local SNR(Dinj)] (Para 0093);
calculating a calibration uptake value [determined…uptake period] (Para 0082) of the target anatomy of the patient based on the calibration image using the measured radiotracer activity concentration [function of any quantity related to activity] (Para 0082) a decay corrected amount of injected radiotracer (Claim 19), and a weight of the patient (Claim 30)
[SNR is determined as a function of any quantity related to activity, such as uptake period; excretion fraction; and dose fractionation, that is, a dose administered in several partial doses] (Para 0082);
comparing [correlated] (Para 0090) the calibration uptake value [peak SNR] (Para 0089) to a reference uptake value [the optimal dose is known for each scan completed and is statistically correlated via the database with important patient characteristics] (Para 0090) [patient characteristics such as…peak SNR] (Para 0089),
Examiner’s Note: It is understood, from paragraphs 0080-0089, that the optimal or peak SNR is a function of radiotracer uptake period and is used to determine the optimal dosage. The peak SNR of the database is the specified reference uptake.
wherein the reference uptake value is specific to age and sex of the patient [patient characteristics such as weight, body mass index (BMI), sex, disease, diabetes state] (Para 0089);
modifying at least one of an initial scan duration [The appropriate adjustments to scan duration and injected dose are then determined to best utilize count rate performance] (Para 0119); and
wherein the modified scan parameters comprise at least one of a modified scan duration [The appropriate adjustments to scan duration and injected dose are then determined to best utilize count rate performance] (Para 0119)
Watson fails to teach the steps of outputting a notification, modifying in response to user input and acquiring image data according to modified scan parameters. However, Vosniak teaches –
notifying an operator of the PET system [The differences may be displayed in a chart, such as the chart 400 (shown in FIG. 5)] (Para 0024) of recommendations for modification to initial scan parameters based on comparison between the calibration uptake value and the reference uptake value [to provide notification of differences between the stored scan protocol and the current scan protocol and/or generate a recommended scan protocol] (Para 0019 and Figure 5);
modifying based on comparison between the calibration uptake value and the reference uptake value in response to operator input [the operator may input a new scan protocol based on the stored scan protocol 118 and the current scan protocol 114. The new scan protocol may include modifications to the stored scan protocol 118 and/or the current scan protocol 114] (Para 0024);
obtaining diagnostic imaging data according to modified scan parameters [imaging system may utilize the recommended scan protocol or a user selected scan protocol to acquire scan data of an object] (Para 0019), thereby providing improved or more conclusive analysis of the images and improved image quality (Para 0003) in a time efficient manner and better accuracy (Para 0004)
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 method of Watson to include the steps of outputting a notification, modifying in response to user input and acquiring image data according to modified scan parameters as taught by Vosniak in order to provide improved or more conclusive analysis of the images and improved image quality (Para 0003) in a time efficient manner and better accuracy (Para 0004).
Watson and Vosniak fail to teach wherein the target anatomy is a region of the brain. However, Sawyer teaches wherein the target anatomy is determined to be a brain of the patient [imaging techniques for brain and other neoplasms] (Para 0003 and Para 0081) in order to produce diagnostic, outcome, testing and therapeutic information about the disease and disease treatment for the brain (Para 0015)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Watson and Vosniak to wherein the target anatomy is the brain as taught by Sawyer in order to produce diagnostic, outcome, testing and therapeutic information about the disease and disease treatment for the brain (Para 0015)
Claim 17/16: Watson teaches wherein the modified field of view comprises removal of a hot location from the initial field of view [a region of interest in an image is determined…and used to estimate a local SNR(Dinj)] (Para 0093).
Examiner’s Note: The application of the region of interest results in the removal of the hot spot location outside of the region of interest.
Claim 19/16: Watson teaches wherein the calibration image [Calibration is performed] (Para 0084) is obtained according to the initial scan parameters [pre-scanned].
Claim(s) 18 & 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Watson et al. (U.S. Patent Application 2005/0129170 A1) and Vosinak et al. (U.S. Patent Application 2012/0271840 A1) as applied to Claim 16 above, and further in view of Vosinak et al. (U.S. Patent Application 2013/0131422 A1; referred to herein as Vosinak‘422).
Claim 18/16: Watson teaches further comprising obtaining the diagnostic
imaging data according to initial scan parameters
Watson fails to teach in response to determination that the calibration uptake value is within range of the reference uptake value. However, Vosinak‘422 teaches in response to determination that the calibration uptake value is within range of the reference uptake value [if the data communicated exceeds a threshold or is not within a range based on a standard for a specific protocol, a warning may be provided] (Para 0053 and See the rejection above for Claim 8) in order to perform data checking (Para 0053)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Watson and Vosinak to include the SUV of Vosinak‘422 in order to perform data checking (Para 0053).
Claim 20/16: Watson and Vosinak fails to teach SUV. However, Vosinak‘422 teaches wherein the calibration uptake value is one of a standardized uptake value (SUV) (Figure 3, Element 200 SUV) in order to perform data checking (Para 0053)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Watson and Vosinak to include the SUV of Vosinak‘422 in order to perform data checking (Para 0053).
Response to Arguments
Applicant’s arguments, see Page 9-10, filed 11/04/2025, with respect to 35 USC § 112 Rejections have been fully considered and are persuasive. The 35 USC § 112 Rejections of the Claims have been withdrawn. However as a result of the new amendments new 35 USC § 112 rejections are pending above.
Applicant’s arguments, see Page 11-12, filed 11/04/2025, with respect to the rejection(s) of claim(s) 8-12 & 15 under Vosinak et al. (U.S. Patent Application 2012/0271840 A1) and further in view of Vosinak et al. (U.S. Patent Application 2013/0131422 A1; referred to herein as Vosinak‘422) have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Vosinak et al. (U.S. Patent Application 2013/0131422 A1) in view of Vosinak et al. (U.S. Patent Application 2012/0271840 A1) and the other rejections listed above.
Conclusion
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/Helene Bor/Examiner, Art Unit 3797
/CHRISTOPHER KOHARSKI/Supervisory Patent Examiner, Art Unit 3797