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 .
Priority
Acknowledgment is made of applicant's claim for foreign priority based on an application filed in the European patent office on 11/30/2021. It is noted, however, that applicant has not filed a certified copy of the EP21211277.5 application as required by 37 CFR 1.55. Of note, please reference the two notices of failed priority document exchange mailed to applicant on 12/06/2024 and on 08/22/2025.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 5/16/2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Drawings
The drawings are objected to because: the unlabeled rectangular box(es) shown in Figure 3 should be provided with descriptive text labels. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The abstract of the disclosure is objected to because the abstract should be generally limited to a single paragraph within the range of 50 to 150 words in length. Currently the word count is approximately 190 words. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
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.
Claims 1-9, 12-14, 16 are rejected under 35 U.S.C. 103 as being unpatentable over US 2019/0247427 to Geiger et al in view of US 2019/0380806 to Spahn et al.
With regard to claim 1, Geiger et al discloses a computer-implemented method for assisting positioning of a subject {having an implant} in X-ray imaging(see [0001], [0015]. And [0019] “x-ray”), the method comprising: receiving X-ray image data of the subject {including the implant} (see [0042] where Geiger et al discloses that an initial scan, i.e. x-ray of the patient is used as an “as-is” reference image in order to begin the pose/alignment process); receiving exam request data indicating at least an exam type to be performed {for the specific implant} (see [0024] where a given diagnosis or treatment drives the selection of the exam request data), and determining at least one set of image features being assigned to the requested exam type and indicative for positioning of the subject relative to an X-ray imaging device (see [0024] and [0026] where protocol is used to establish the parameters (pose) for positioning of the subject); analyzing an image content of the received X-ray image data for the determined set of image features; and determining, from the analysis of the image content, a feedback being indicative for positioning the subject and the X-ray imaging device to each other with respect to a target positioning (see [0043] - [0047] where the actual pose of the patient is compared to the desired pose of the specific procedure), to be provided for assisting the positioning, wherein the set of image features defines {at least a contour of the implant, and wherein the contour is determined to meet a corresponding target contour} defined by the set of image features in case of meeting the target positioning (see [0054] where a display provides an outline of the desired pose in relation to the patient’s current pose by overlaying the two).
However, as noted by the { } above, Geiger et al fails to disclose the claimed patient having an implant for positioning of the patient relative to the X-ray device with the implant having a corresponding contour.
In the same field of endeavor (patient orientation/pose relative to a medical imaging device), Spahn et al discloses in [0045] and [0046] that patient alignment with an X-ray device can rely upon knowledge of the image recording purpose, information relating to a current examination region, and information relating to implants while at [0053] Spahn et al explicitly recites that any implants of the patient are taken into consideration for imaging.
Therefore, it would have been obvious before the effective filing date of the claimed invention to have provided the patient/X-ray device alignment process used by Geiger et al with the additional capability to model any implants of the patient during alignment calculations as taught by Spahn et al as doing so would have permitted enhanced alignment between the patient and X-ray device and allow for modelling of the implant to be part of the alignment process. It is noted that just as human skeletal structures and organs have various shapes and contours, the implants taught by Spahn et al would inherently have contours that could be used to assist in aligning the patient with the X-ray machine.
With regard to claim 2, Geiger et al discloses the method according to claim 1, wherein the set of image features is analyzed with respect to its appearance in case of the target positioning (see [0046] - [0049]).
With regard to claim 3, Geiger et al discloses the method according to claim 1, wherein analyzing the image content comprises measuring the set of image features to determine compliance with and/or deviation from the target positioning (see [0047] - distance is measured).
With regard to claim 4, Geiger et al discloses the method according to claim 1, wherein the set of image features comprises one or more geometric parameters to be measured within the image content (see [0047]).
With regard to claim 5, Geiger et al discloses the method according to claim 4, wherein the one or more geometric parameters define one or more of a straight line, a curved line, a curve, and a polygon (inherent in the subtraction technique disclosed by Geiger et al [0047] is the differences between curves, straight lines and polygons that make up the patient’s organs, skeleton, etc).
With regard to claim 6, Geiger et al discloses the method according to claim 1, wherein the set of image features define a contour of tissue being adjacent to and/or surrounding the implant, and wherein the contour is determined to meet a corresponding target contour defined by the set of image features in case of meeting the target positioning (see Geiger et al at [0054] where an overlay (template) is used on a display screen to assist in aligning the actual pose of the patient with the desired pose of the particular procedure). Procedures involving implants as taught by Spahn et al would also be able to be aligned in a similar fashion to tissue/bones/organs, etc.
With regard to claim 7, Geiger et al discloses the method according to claim 1, wherein analyzing the image content comprises determining symmetry properties of sections of the implant and/or tissue to each other based on the set of set of image features (see [0047] where a subtraction analysis between poses would automatically account for any symmetry present).
With regard to claim 8, Geiger et al discloses the method according to claim 1, wherein, during analyzing the image content, the set of image features is fed into a 3D implant model being similar to the implant and being configured to estimate a 3D pose and/or posture of the implant (see [0042] where patient pose data is a 3-D point cloud and 3-D volume).
With regard to claim 9, Geiger et al discloses the method according to claim 1, wherein the set of image features is fed into a 3D anatomy model of the anatomy of interest configured to estimate a 3D pose and/or a posture, wherein the feedback is determined based on the 3D anatomy model (see [0042], [0045] and [0046]).
With regard to claim 12, Geiger et al discloses the method according to claim 1, wherein a relative position of the implant to the subject's tissue is recorded (see 0054] and the display registers the desired pose and the actual pose of the patient).
Claims 13, 14 and 16 are rejected for reasoning, mutatis mutandis, as that of claim 1 above. In addition, Geiger et al discloses the additional limitations of a processor 20, memory 22, a computer-readable medium (see [0071] and [0074]), and a communications interface (see “display” at [0054]).
Allowable Subject Matter
Claims 10-11 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.WO2016/184704A1 and US PGPub 2019/0066260 disclose the general state of the art surrounding the proper positioning and alignment of a patient in relation to a medical scanning device such as an X-ray machine.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVID OMETZ whose telephone number is (571)272-7593. The examiner can normally be reached M-F, 8am-4pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sumati Lefkowitz can be reached at 571-272-3638. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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DAVID OMETZ
Primary Examiner
Art Unit 2672
/DAVID OMETZ/ Primary Examiner, Art Unit 2672