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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 05/26/2026 has been entered.
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: “movement data processing unit” in claims 10 and dependents, and “data correction unit” in claims 6 and 15.
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 § 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.
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 , and 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Huang et al. (US 2022/0117494 A1, Apr. 21, 2022) (hereinafter “Huang”) in view of Yu et al. (US 2015/0366527 A1, Dec. 24, 2015) (hereinafter “Yu”) and Sachs et al. (US 2013/0310655 A1, Nov. 21, 2013) (hereinafter “Sachs”).
Regarding claim 1: Huang discloses a method of identifying movement of a patient during a medical imaging scan, the method comprising: initiating motion detection data acquisition using at least one motion detection apparatus configured to obtain patient contour data ([0120]-[0121], where these paragraphs refer back to previously described steps associated with figs. 6-8; [0089] – a region on the surface of the patient or a position on the surface of the patient is “contour data”; [0044]-[0046] - the "motion detection apparatus" is the laser ultrasonic component of a medical device); initiating a medical imaging scan of the patient to acquire scan data ([0121] - "during the scan" means that the medical imaging scan is also initiated, [0124]).
While Huang discloses that movement data of rigid or non-rigid motion may be acquired from a surface of the patient, including a position on the surface of the skin ([0089]), Huang is silent on wherein the patient contour data includes a three-dimensional representation of a surface of the patient.
Yu, in the same field of endeavor, discloses detecting patient motion using a 3D patient surface model ([0067], [0076]).
It would have been prima facie obvious for one having ordinary skill in the art prior to the effective filing date of the claimed invention to implement the contour data of Huang as a 3D surface representation (model) as taught by Yu in order to more accurately capture the rigid and non-rigid motion from the surface region of the patient.
Further regarding claim 1: Huang and Yu disclose computing a numeric motion score based on the patient contour data and embedding the motion score with the corresponding scan data (Huang - [0125] - value 1 and value 0 are "a numeric motion score" where the data is synchronized ["embedded"] with the scan data); determining a motion score curve for duration of the medical imaging scan based on the motion detection data ([0125] - retrospective gating curve); removing portions of the scan data corresponding to a motion score curve outside of an acceptable range ([0125]); and selecting the scan data corresponding to a motion score curve within the acceptable range for reconstruction ([0125]).
While the numeric score of Huang and Yu encompasses all of the acquired image data, Huang is silent on the numeric score being calculated for each view of the scan.
Sachs, in the same field of endeavor, discloses acquiring medical image scan data comprising a plurality of frames (“views”) and having a time stamp value ([0025]) along with motion detection data of a patient contour ([0040], [0042]), having a time stamp value corresponding to the image timing information ([0027], [0033], [0046]), that may be from various sources including a non-contact motion detection apparatus ([0028], [0039]), and wherein computing the numeric motion score includes comparing spatial position information of the patient contour at the corresponding view to spatial position information of a baseline patient contour to determine differences in position ([0033] – reference position or “initially determined base position”, [0041] – base profile or base position). Sachs further discloses determining of the magnitude of the motion data meets or exceeds a threshold ([0049]) and the image data and motion data are associated (“embedded”) ([0051]). Sachs further discloses that operating on individual frames (and corresponding motion data) reduces artifacts, such as residual blur or “before and after” motion, caused by time window division ([0005]).
It would have been prima facie obvious for one having ordinary skill in the art prior to the effective filing date of the claimed invention to determine the numeric motion score of Huang and Yu based on individual frame comparison to baseline rather than time windows in order to reduce motion artifacts in view of the teachings of Sachs.
Regarding claim 2: Huang, Yu and Sachs disclose the method of claim 1. Huang further discloses wherein the motion score curve is a compilation of motion scores calculated for each view for the duration of the scan ([0125] - "synchronously").
Regarding claim 3: Huang, Yu and Sachs disclose the method of claim 2. Huang and Sachs further discloses determining a baseline position of the patient used to determine the motion score for each view (Huang - [0125] – this is considered to be implicitly disclosed as the image-based motion is measured as a displacement/change in position over time; there must be an initial determination of the position - "baseline" - in order to measure the subsequent motion, where the subsequent motion measurements are the "motion score" for each frame; Sachs - [0033] – reference position or “initially determined base position”, [0041] – base profile or base position).
Regarding claims 4 and 5: Huang, Yu and Sachs disclose the method of claim 1. Huang further discloses wherein the motion score curve is determined for a contour of the patient or for a surface of the patient ([0121]-[0124] refer back to previously described steps associated with figs. 6-8; [0089]-[0092], [0095] - a surface, a contour, or both may be used).
Regarding claim 7: Huang, Yu and Sachs disclose the method of claim 1. Huang further discloses wherein the motion detection data acquisition uses one or more motion detection apparatuses to detect motion in real-time during the scan ([0125]).
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Huang, Yu and Sachs as applied to claim 1 above, and further in view of Kaufman et al. (US 2003/0016782 A1, Jan. 23, 2003) (hereinafter “Kaufman”).
Regarding claim 6: Huang, Yu and Sachs disclose the method of claim 1. Huang further discloses wherein selecting the scan data corresponding to a motion score curve within the acceptable range is automatically determined by a data correction unit ([0125]) but does not disclose wherein a user confirms the selection.
Kaufman, in the same field of endeavor, teaches a retrospective gating technique where the user can revise the gating slice selections made by the system in order to remove any slices that may be poor quality (fig. 1, [0060]).
It would have been prima facie obvious for one having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the method of Huang, Yu and Sachs by providing the user with an opportunity to revise (“confirm”) the automated selections as taught by Kaufman in order to ensure a quality reconstruction.
Claim(s) 8-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Huang, Yu and Sachs as applied to claim 7 above, and further in view of Anthony et al. (US 2021/0076944 A1, Mar. 18, 2021) (hereinafter “Anthony”).
Regarding claims 8 and 9: Huang, Yu and Sachs disclose the method of claim 7. Huang further discloses wherein the motion detection apparatus(es) comprises a laser ultrasound device, but is silent on the motion detection apparatus(es) including a LiDAR scanner or a 3D camera.
Anthony, in the same problem solving area of laser ultrasound, teaches that laser ultrasound can be optimized for use on a patient by incorporating additional point tracking, such as LiDAR and/or a camera, to compensate for irregularities of the patient's skin surface and body shape (fig. 5, [0070], [0072]-[0073], where at least stereo and structured light cameras are "3D camera[s]").
It would have been prima facie obvious for one having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the method of Huang, Yu and Sachs by including a LiDAR and/or 3D camera with the laser ultrasound device as taught by Anthony in order to optimize the localization and compensate for irregularities of the patient’s skin surface.
Claim(s) 10-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Huang et al. (US 2022/0117494 A1, Apr. 21, 2022) (hereinafter “Huang”) in view of Kiely (US 2021/0353244 A1, Nov. 18, 2021) (hereinafter “Kiely”) and Sachs et al. (US 2013/0310655 A1, Nov. 21, 2013) (hereinafter “Sachs”).
Regarding claim 10: Huang discloses a medical imaging system ([0048]), comprising: a computed tomography (CT) imaging system ([0041]-[0042], [0049]), comprising: a gantry having a bore, rotatable about an axis of rotation; an X-ray source mounted on the gantry and configured to emit an X-ray beam ([0042]); an X-ray controller to operate the X-ray source ([0042], [0048]); and an X-ray detector configured to detect the X-ray beam emitted by the X-ray source ([0042]); a motion detection system coupled to the CT imaging system, wherein the motion detection system includes: a motion detection apparatus mounted on the gantry and configured to obtain patient contour data representing a surface contour of a patient (laser ultrasonic component 160, 420, 520; [0046] – a reconstructed image is “patient contour data” [0048], [0064], [0074]-[0077], figs. 4-5; [0089] – a position or a region on the surface of a patient including “surface of the skin above the sternum” is a “surface contour of a patient). While Huang discloses that movement data of rigid or non-rigid motion may be acquired from a surface of the patient, including a position on the surface of the skin ([0089]), Huang is silent on the patient contour data representing a three-dimensional point cloud or mesh of the surface contour of the patient.
Kiely, in the same problem solving area of patient motion determination, discloses generating a point cloud model of the patient’s surface to measure the patient’s breathing ([0196]-[0197]).
It would have been prima facie obvious for one having ordinary skill in the art prior to the effective filing date of the claimed invention to implement the contour data of Huang as a 3D point cloud representation as taught by Kiely in order to more accurately capture the rigid and non-rigid motion from the surface region of the patient.
Further regarding claim 10: Huang and Kiely disclose a controller to control operation of the motion detection apparatus (Huang - [0048], processing device 120, [0068], [0079]); and a movement data processing unit to obtain data from the motion detection apparatus, wherein the movement data processing unit obtains real-time patient contour data during an imaging scan to generate contour-based motion information (Huang - [0121]-[0124] refer back to previously described steps associated with figs. 6-8; [0095]-[0096]; [0125]); and a processor to determine a numeric motion score of the patient based on the contour data, embed the motion score with the corresponding view of scan data, and select views of scan data in which the corresponding motion score is in an acceptable range for image reconstruction (Huang - [0125] - value 1 and value 0 are "a numeric motion score" where the data is synchronized ["embedded"] with the scan data).
While obtaining a baseline position of the patient is considered to be implicitly disclosed as the image-based motion is measured as a displacement/change in position over time; there must be an initial determination of the position - "baseline" - in order to measure the subsequent motion. However, Huang is silent on the details of how the motion calculation is performed and does not describe wherein the real-time movement data is compared to the baseline position of the patient. Additionally, while the numeric score of Huang encompasses all of the acquired image data, Huang is silent on the numeric score being calculated for each view of the scan.
Sachs, in the same field of endeavor, discloses acquiring medical image scan data comprising a plurality of frames (“views”) and having a time stamp value ([0025]) along with motion detection data of a patient contour ([0040]-[0042]; ribcage, “outline of the patient”), having a time stamp value corresponding to the image timing information ([0027], [0033], [0046]), that may be from various sources including a non-contact motion detection apparatus ([0028], [0039]) and is relative to a baseline position ([0041] – “base position”). Sachs further discloses determining of the magnitude of the motion data meets or exceeds a threshold ([0049]) and the image data and motion data are associated (“embedded”) ([0051]). Sachs further discloses that operating on individual frames (and corresponding motion data) reduces artifacts, such as residual blur or “before and after” motion, caused by time window division ([0005]); and that measurement relative to a baseline position allows the magnitude of the motion to be measured.
It would have been prima facie obvious for one having ordinary skill in the art prior to the effective filing date of the claimed invention to measure the motion relative to the baseline position (“base position”) as disclosed by Sachs in order to easily determine the magnitude of the motion. It would further have been prima facie obvious for one having ordinary skill in the art prior to the effective filing date of the claimed invention to determine the numeric motion score of Huang and Kiely based on individual frames rather than time windows in order to reduce motion artifacts in view of the teachings of Sachs.
Regarding claim 11: Huang, Kiely and Sachs disclose the system of claim 10. Huang further discloses determining a motion score curve from a compilation of the motion scores calculated for each view for the duration of the scan ([0121]-[0124] refer back to previously described steps associated with figs. 6-8; [0095]-[0096]; [0125]).
Regarding claim 12: Huang, Kiely and Sachs disclose the system of claim 10. Huang and Sachs further discloses wherein the motion score is based on the baseline position of the patient and the real-time movement data corresponding to each view during the scan (Huang - [0125]; Sachs – [0033], [0041]).
Regarding claims 13 and 14: Huang, Kiely and Sachs disclose the system of claim 10. Huang further discloses wherein the motion score curve is determined for a contour of the patient or for a surface of the patient ([0121]-[0124] refer back to previously described steps associated with figs. 6-8; [0089]-[0092], [0095] - a surface, a contour, or both may be used).
Regarding claim 15: Huang, Kiely and Sachs disclose the system of claim 10. Huang further discloses wherein the processor includes a data correction unit to automatically select the views of the scan data corresponding to the motion score within the acceptable range ([0125], processing device 120).
Claim(s) 16-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Huang, Kiely and Sachs as applied to claim 10 above, and further in view of Anthony et al. (US 2021/0076944 A1, Mar. 18, 2021) (hereinafter “Anthony”).
Regarding claims 16-17: Huang, Kiely and Sachs disclose the system of claim 10 wherein the motion detection apparatus(es) comprises a laser ultrasound device, but is silent on the motion detection apparatus(es) including a LiDAR scanner or a 3D camera.
Anthony, in the same problem solving area of laser ultrasound, teaches that laser ultrasound can be optimized for use on a patient by incorporating additional point tracking, such as LiDAR and/or a camera, to compensate for irregularities of the patient's skin surface and body shape (fig. 5, [0070], [0072]-[0073], where at least stereo and structured light cameras are "3D camera[s]").
It would have been prima facie obvious for one having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the system of Huang, Kiely and Sachs by including a LiDAR and/or 3D camera with the laser ultrasound device as taught by Anthony in order to optimize the localization and compensate for irregularities of the patient’s skin surface.
Response to Arguments
Applicant’s arguments, filed 05/26/2026, have been fully considered but are moot in view of the updated grounds of rejection necessitated by amendment.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CAROLYN A PEHLKE whose telephone number is (571)270-3484. The examiner can normally be reached 9:00am - 5:00pm (Central Time), Monday - Friday.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Chris Koharski can be reached at (571) 272-7230. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CAROLYN A PEHLKE/Primary Examiner, Art Unit 3799
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