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 .
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Claim 1 recites:
receiving, via a processing system comprising one or more processors, a prescription for a diagnostic x-ray scan of a subject with a medical imaging scanner, wherein diagnostic x-ray scan has a prescribed value for a target metric (merely a data gathering step, see MPEP 2106.05);
determining, via the processing system, a predicted value for the target metric for an altered prescription for the diagnostic X-ray scan based on alteration of the prescription by an automatic control exposure algorithm (a mathematical calculations step; MPEP 2106.04(a)(2)(I));
receiving, via the processing system, an input of a threshold value in a graphical user interface, wherein the threshold value is an acceptable percent deviation between the predicted value and the prescribed value for the target metric (merely a data gathering step, see MPEP 2106.05); and
determining, via the processing system, whether the altered prescription for the diagnostic X-ray scan is sub-optimal based on a comparison of the threshold value to a percent deviation between the predicted value and the prescribed value for the target metric (mental process and/or mathematical calculations step; MPEP 2106.04(a)(2)(III)).
The additional elements beyond the abstract idea are a “medical imaging scanner”, and “a processing system comprising one or more processor”. Each of these is recited generically only to gather the inputs and to act as a means of describing the field of use, or an “apply it” step of the abstract idea. The additional elements amount to no more than generic components and performing their well-understood, routine, and conventional functions of receiving data, performing a mathematical comparison, and outputting a display, consistent with Electric Power Group and SAP America case law. Finally, the proposed technical effect is giving “the user control over how much of a deviation from a target value…may be accepted,” which is simply a restatement of the abstract threshold-comparison idea rather than a technical improvement to a computer or imaging system (Specification, [0074]). The claims to not amount to significantly more than the abstract idea. Claims 2-13 are dependent claims that merely limit the abstract idea itself rather than adding a technical integration. Claim 14 is a corresponding apparatus claim that claims substantially the same features as the method claim 1, and is rejected according to the same rationale. Claims 15-20 are dependent claims that merely limit the abstract idea itself rather than adding a technical integration.
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 17 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.
Claim 17 depends from claim 15 and recites “[T]he system of claim 1, automatically accepting the altered prescription when the percent deviation is equal to or less than the threshold value for the target metric.” Claim 17 provides no lead-in clause identifying what structure performs the recited function. One of ordinary skill in the art would not be able to determine the scope of the claim.
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-20 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1 recites the phrases “determining, via the processing system, a predicted value for the target metric for an altered prescription for the diagnostic X-ray scan based on alteration of the prescription by an automatic control exposure algorithm” and “determining, via the processing system, whether the altered prescription for the diagnostic X-ray scan is sub-optimal based on a comparison of the threshold value to a percent deviation between the predicted value and the prescribed value for the target metric”. Each of the instant phrases amount to a computer-implemented functional claim limitation (CIFCL). MPEP 2161.01 explains that any CIFCL must be supported in the specification with a mathematical formula, prose, or flow chart of the corresponding algorithms. While the applicant’s disclosure provides various examples of thresholds and generic workflows (FIG. 3-5; system level, protocol level, series level, group level, task level, etc., Specification, [0048]), the disclosure fails to provide explicit support for how the respective “determining” steps are performed for each of the target metrics. No specific algorithm is provided for (1) determining a predicted value for the each and every of the target metrics, and/or (2) determining whether the altered prescription is sub-optimal based on a comparison of the target metrics. MPEP 2161.01 further explains that “generic claim language in the original disclosure does not satisfy the written description requirement if it fails to support the scope of the genus claimed. Ariad, 598 F.3d at 1349-50, 94 USPQ2d at 1171.” Claim 14 recites substantially similar limitations and is rejected according to the same rationale. Claims 2-13 and 15-20 are rejected on dependence.
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.
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.
Claims 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over CROTTY et al. (US 20170202534 A1) in view of LARSON (US 20140270053 A1).
Regarding claims 1, 14 and 20, CROTTY discloses a system, method and NTCRM with instructions for thresholding to optimize an X-ray technique, comprising:
providing a medical imaging system, the medical imaging system including:
a memory encoding processor-executable routines (processor 216 with instructions in memory; [0054]); and
a processing system comprising one or more processors and configured to access the memory and to execute the processor-executable routines (processor 216 with executable instructions in memory; [0054]), wherein the processor-executable routines, when executed by the processing system, cause the processing system to:
receive a prescription for a diagnostic X-ray scan of a subject with a medical imaging scanner, wherein diagnostic X-ray scan has a prescribed value for a target metric (a scan prescription is received with a user-prescribed image quality target 310 or dose metric 308; [0038, 0042, 0055]);
determine a predicted value for the target metric for an altered prescription for the diagnostic X-ray scan based on alteration of the prescription by an automatic control exposure algorithm (AEC algorithm determines exposure parameters based on imaging conditions, such as size, and predicts an image quality (IQ). The AEC-adjusted kV, mA, exposure time, rotation time, and pitch describe the altered prescription, and the predicted noise index or predicted dose for that AEC prescription is the predicted value for the target metric; [0044, 0048, 0049, 0060-0061]);
receive an input of a threshold value in a graphical user interface (user prescribed inputs can be entered via user interface 400 of display 232 of the AEC module of the CT, wherein the prescribed range of values for the dose metric or imaging quality may be a range of acceptable IQ values; [0046, 0048, 0061]); and
determine whether the altered prescription for the diagnostic X-ray scan is sub-optimal based on a comparison of the threshold value to a percent deviation between the predicted value and the prescribed value for the target metric (determine if predicted IQ is higher than a threshold, and if the predicted IQ is outside an acceptable range determine the diagnostic scan may be compromised; [0061]).
CROTTY does not specify wherein the threshold value is an acceptable percent deviation between the predicted value and the prescribed value for the target metric. In the same field of endeavor, LARSON discloses a method of dose optimization in CT imaging, comprising providing an operator-specified target for image quality ([0142-0143]), and teaches quantifying the deviation between predicted and actual values of those metrics in percentage terms ([0146]), with the benefit of consistent CT radiation dose optimization ([0002]). In light of the teachings of LARSON, it would have been obvious to one of ordinary skill in the art at the time of filing to combine with the teachings of CROTTY.
Regarding claims 2 and 15, CROTTY discloses in the predicted IQ is below the threshold then the user may be prompted (via GUI) to adjust the dose metric or otherwise ([0062, 0063]), but does not specify a percent deviation. LARSON discloses the invention further comprising providing the percent deviation exceeds the threshold value for the target metric when the percent deviation exceeds the threshold value for the target metric, for the reasons specified in claim 1 above (providing an alert if the image quality falls outside the acceptable parameters; [0036]).
Regarding claims 3 and 16, LARSON further discloses wherein the user-perceptible indication comprises a recommendation to change one or more parameters of the altered prescription to optimize the altered prescription (the system may recommend scan parameters to the CT technologist ([0036, 0057]).
Regarding claims 4 and 18, LARSON discloses wherein the user-perceptible indication comprises an option to accept the altered prescription even though the altered prescription for the diagnostic X- ray scan is sub-optimal, and the computer-implemented method further comprises receiving user input via the graphical user interface to accept the option (operator is shown whether the expected result is within or outside parameters, but is permitted to set dose parameters manually; [0036, 0140]).
Regarding claims 5 and 17, LARSON further discloses the invention comprising automatically accepting, via the processing system, the altered prescription when the percent deviation is equal to or less than the threshold value for the target metric (performing the scan at the AEC-calculated output level without further user intervention when the deviation is within the threshold is automatic acceptance of the altered prescription; [0044, 0063]).
Regarding claim 6, LARSON discloses recommending acceptable dose parameters that would generate acceptable image quality, and allowing a user to manually set the dose parameters, and prompting the user when the expected image quality falls within or outside acceptable ranges ([0036, 0057]). Thus, it would have been obvious to one of ordinary skill in the art at the time of filing to prompt the user to accept within-range parameters prior to performing an imaging.
Regarding claim 7, LARSON discloses receiving the input of the threshold value in the graphical user interface comprises receiving, via the processing system, user input of the threshold value ([0036]).
Regarding claim 8, LARSON further discloses the invention comprising altering, via the processing system, the threshold value inputted via user input to a system threshold value when the threshold value inputted via the user input exceeds a system threshold value, wherein the system threshold value is a value that results in an accepted tolerance for the target metric across all protocols, all series, and all groups for scans with the medical imaging scanner ([0036, 0057]).
Regarding claim 9, LARSON discloses the invention wherein receiving the input of the threshold value in the graphical user interface comprises automatically obtaining, via the processing system, a preset threshold value (maintains scan protocols for a plurality of scanners within a central database, and accessing databases for clinical applications; [0037, 0051, 0138]).
Regarding claim 10, LARSON discloses the invention wherein the preset threshold value is a site level threshold value for a site comprising one or more medical imaging scanners including the medical imaging scanner, a system level threshold value for the medical imaging scanner, a protocol level threshold value specific to a particular medical imaging protocol with the medical imaging scanner, a series level threshold value specific to scanning one or more groups with the particular medical imaging protocol with the medical imaging scanner, or a group level threshold value specific to scanning an individual with the particular medical imaging protocol with the medical imaging scanner (centrally maintained scan protocols for plurality of scanners within a database, with the ability of interfacing with all scanners in an organization (site wide); [0051]), wherein per-protocol and per-group image quality parameters meet the site level, protocol level, and group level alternatives ([0139]).
Regarding claims 11 and 19, LARSON discloses wherein the graphical user interface is configurable by a user to present the graphical user interface in a first manner when the percent deviation exceeds the threshold value for the target metric and to present the graphical user interface in a second manner different from the first manner when the percent deviation is equal to or less than the threshold value for the target metric (displaying which scans fell within expected image quality parameters, and which ones fell outside expected image quality parameters within a chart; [0049, 0062]).
Regarding claim 12, CROTTY discloses wherein the target metric comprises a noise index ([0042, 0048, 0057]).
Regarding claim 13, CROTTY discloses the invention wherein the target metric comprises a comparison between an average tube current of the prescription and an average tube current determined to be optimal by the automatic control exposure algorithm ([0044]), but does not specify the target metric as a ratio between an average tube current of the prescription and an average tube current determined to be optimal by the AEC. LARSON discloses modeling the scanner’s dose modulation algorithm for predicting average mA for a given patient size at specified dose modulation parameter settings ([0142]), and comparing the predicted to the actual as a percent difference ([0145-0146]) between two tube current values being their ratio expressed as a percentage, with the benefits established in claim 1. In light of the teachings of LARSON, it would have been obvious to one of ordinary skill in the art at the time of filing to combine the teachings of LARSON to arrive at the claimed invention.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CASEY BRYANT whose telephone number is (571)270-7329. The examiner can normally be reached M-F // 7-3P EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, UZMA ALAM can be reached at 571-272-3995. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
CASEY BRYANT
Primary Examiner
Art Unit 2884
/CASEY BRYANT/ Primary Examiner, Art Unit 2884
Prosecution Insights