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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 02/05/2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “radiation dose model” in claim 1.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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 (i.e., changing from AIA to pre-AIA ) 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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-2, 5-11, 14-17 and 20 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Lee et al (“Lee” hereinafter, U.S. Publication No. 2014/0185762 A1).
As per claim 1, Lee discloses a system for estimating an optimal radiation does (abstract and figures 14-15) comprising: a scouting image circuit (controller 130 in figure 100 includes a condition setting unit 131) configured to cause an x-ray sensor to operate at a first gain setting to capture a scouting image using a scouting image radiation dose (paragraph [0080] & [0129] & figure 1, numeral 521: “acquiring image signal of subject by pre-shot”; the condition setting 131 sets the gain and radiation dosage for pre-shot; the examiner notes the pre-shot image is the claimed “scouting image”); a radiation dose model configured to provide a diagnostic image radiation dose based on the scouting image (paragraph [0095]: “The first reference level and the second reference level are signal levels based on a relationship between the X-ray dose to be radiated in the pre-shot and the X-ray dose to be radiated in the main shot”; figure 14: numeral 522-529: the pre-shot image signal of the subject is analyzed to determine the adjusted gain and radiation dosage for main shot image of the subject; the main shot is the claimed “diagnostic image”); and a diagnostic image circuit configured to cause the x-ray sensor to operate at a second gain setting to capture a diagnostic image using the provided diagnostic image radiation dose (paragraph [0141]: “The image signal acquired by the pre-shot is analyzed and imaging conditions such as tube voltage, tube current, X-ray exposure time, etc. to be applied in the main shot are set. The main shot may be performed according to the set imaging conditions.”), wherein the second gain setting is less than the first gain setting (paragraph [0138]: “gain of the single pixel region is set to a value lower than original gain (524)”).
As per claim 2, Lee discloses wherein the diagnostic image radiation dose is greater than the scouting image radiation dose (paragraph [0092]: “when output voltage of any pixel region in an image signal acquired by pre-shot is 2V and the X-ray dose to be radiated upon performing the main shot is set to twice that of the pre-shot”).
As per claim 5, Lee discloses a communication link between a controller and the x-ray sensor, the controller comprising the scouting image circuit and the diagnostic image circuit, wherein the communications link is configured to provide gain settings to the x-ray sensor and radiation dose setting to an x-ray emitter, and to receive the scouting image and the diagnostic image from the x-ray sensor (figures 7 & 11).
As per claim 6, Lee discloses wherein the scouting image circuit and diagnostic image circuit comprises a gain control circuit configured to set gain of the x-ray sensor (paragraph [0090]: condition setting unit 131 includes a gain control circuit as shown in figures 7 and 11).
As per claim 7, Lee discloses wherein the scouting image circuit and diagnostic circuit comprises a dosing control circuit configured to set radiation dos of an x-ray emitter (paragraph [0090]).
As per claim 8, Lee discloses wherein the scouting image circuit and the diagnostic circuit comprises one or more processors and one or more memories encoded with instructions (Lee’s system is a computer-like system, which inherently includes at least a processor and a memory).
As per claim 9, Lee discloses an x-ray system (abstract).
As per claim 10, see explanation in claim 1. The examiner notes Lee’s system is a computer-like system, which inherently includes a non-transitory machine-readable medium.
As per claim 11, see explanation in claim 2.
As per claim 14, see explanation in claim 5.
As per claim 15, see explanation in claim 9.
As per claim 16, see explanation in claim 1.
As per claim 17, see explanation in claim 2.
As per claim 20, see explanation in claim 5.
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 (i.e., changing from AIA to pre-AIA ) 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, 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 3-4, 12-13 and 18-19 are rejected under 35 U.S.C. 103 as being unpatentable over Lee in view of Xia et al (“Xia” hereinafter, U.S. Publication No. 2022/0130520 A1).
As per claim 3, Lee teaches a condition setting unit 131 in controller 130 for analyzing the pre-shot image and determine the gain and radiation dosage for acquiring main-shot image. However, Lee does not explicitly teach the controller is a machine learning algorithm trained on a collection of training scouting images paired with training diagnostic images, the training diagnostic images selected to provide a desired diagnostic image quality.
Xia teaches applying machine learning algorithm (numeral 325 in figure 3A) to generate image quality metric with corresponding a radiation dosage based on simulated CT images from scout scan information and scout scan parameters.
Lee and Xia are combinable because they are from the same field of endeavor, X-ray imaging.
At the time of the invention, it would have been obvious to a person of ordinary skill in the art to modify Lee in light of Xia’s teaching to adapt a machine learning algorithm for training scout scan and corresponding simulated CT images to determine image quality with a corresponding dosage to derive imaging parameters. One would be motivated to do so because “the optimal imaging protocol parameters maximize image quality while minimizing radiation exposure” (Xia: abstract).
As per claim 4, the combination of Lee and Xia teaches wherein the radiation dose model is an algorithm, the algorithm configured based on an analysis of a collection of sample scouting images paired with sample diagnostic images, the sample diagnostic images selected to provided a desired diagnostic image quality (see abstract and figure 3A in Xia).
As per claim 12, see explanation in claim 3.
As per claim 13, see explanation in claim 4.
As per claim 18, see explanation in claim 3.
As per claim 19, see explanation in claim 4.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TOM Y LU whose telephone number is (571)272-7393. The examiner can normally be reached Monday - Friday, 9AM - 5PM.
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, Matthew Bella can be reached at (571) 272 - 7778. 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.
/TOM Y LU/Primary Examiner, Art Unit 2667