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 § 102
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- are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Vogtmeier (US 20190021865 A1).
Regarding claim 1, Vogtmeier discloses a surgical method comprising:
accessing a three-dimensional array of data elements describing multiple anatomical features of a subject, each of the data elements having associated therewith positional data (optimized scan acquisition parameters (e.g. radiation dose or distribution, filter optimization, detector sensitivity, etcetera) and/or input parameters reconstruction models that are optimized or even fully dedicated to obtain geometrical information, para. 0026) and a separate parameter value (particularly useful to obtain material information besides geometrical information. With quantitative x-ray or CT imaging information on material density or porosity information may be obtained, para. 0037);
identifying any data elements in the three-dimensional array having an associated parameter value within a predefined range of threshold values (generate three-dimensional image data 24 of the anatomical structure with acquisition and/or reconstruction parameters that were optimized for maximum geometry precision, para. 0026) associated with at least one anatomical feature (phase contrast x-ray or CT imaging enhanced soft tissue contrast is obtained, para. 0037);
acquiring positional data associated with the data elements identified as having an associated parameter value within the predefined range of threshold values associated with the anatomical feature and storing acquired positional data in memory (image parameter selection unit is configured to select the optimized imaging acquisition parameters of the imaging system and/or reconstruction input parameters of the reconstructor, para. 0026 and 3D model parameters; and a 3D model providing unit 23 for directly or indirectly providing the 3D model parameters to a device for fabricating the physical 3D anatomical model, para. 0007);
generating from the acquired positional data stored in the memory a three-dimensional point cloud model of a bony anatomical structure which illustrates a density of the bony anatomical structure (obtain material information besides geometrical information. With quantitative x-ray or CT imaging information on material density or porosity and material x-ray absorption information may be obtained (e.g. by analyzing the Houndsfield unit values for the anatomy of interest), para. 0037); and
selecting hardware for use in a surgical procedure on the subject based on the density of the bony anatomical structure illustrated by a display of the three-dimensional point cloud model of the bony anatomical structure (used for implants (e.g. skull parts, hip, knee, teeth implants) or for study of a patient are known and are fabricated in various manners, such as sculpting, casting, etching, etc. More recently anatomical parts have also been fabricated with 3D printing, para. 0023).
Regarding claim 2, Vogtmeier discloses the surgical method of claim 1, further comprising positioning the hardware based on the density of the bony anatomical structure illustrated by the display of the three-dimensional point cloud model of the bony anatomical structure (adapt fabrication output based on material and/or functional properties within the 3D model parameters, para. 0012).
Regarding claim 3, Vogtmeier discloses the surgical method of claim 1, wherein the three-dimensional point cloud model of the bony anatomical structure which illustrates the density of the bony anatomical structure is associated with cancellous bone beneath an exterior cortical bone surface of the bony anatomical structure (anatomical structure has material information such as structural distribution of material, such as material density or porosity; material energy information, such as radiation absorption or reflection properties, para. 0009 and tissue contrast information, such as contrast of or between hard and soft tissue materials, para. 0009, para. 0023).
Regarding claim 4, Vogtmeier discloses the surgical method of claim 3, further comprising generating, from the positional data associated with the identified data elements, a second three-dimensional point cloud model which illustrates the exterior cortical bone surface of the bony anatomical structure (reconstructing the acquired three-dimensional image data into 3D model parameters, para. 0007 and best contrast at exactly the bone-to-tissue interface to enable precise segmentation and geometry extraction of the selected region of interest, para. 0027).
Regarding claim 5, Vogtmeier discloses the surgical method of claim 4, wherein both of the three-dimensional point cloud models are simultaneously displayable such that the exterior cortical bone surface and the density of cancellous bone beneath the exterior cortical bone surface are simultaneously visually discernable (adapts fabrication output based on material and/or functional properties within the 3D model parameters. Said output the fabrication output preferably includes different colors; color grades; transparency levels for different material parameters, para. 0012).
Regarding claim 6, Vogtmeier discloses the surgical method of claim 1, wherein each parameter value represents a measurement of radio density (information on material density or porosity and material x-ray absorption information may be obtained (e.g. by analyzing the Houndsfield unit values for the anatomy of interest), para. 0037).
Regarding claim 7, Vogtmeier discloses the surgical method of claim 1, wherein at least one of the anatomical features is a vertebral body (an exact geometry for a bone implant requires exact measurement of the existing bone structure, para. 0027).
Regarding claim 8, Vogtmeier discloses the surgical method of claim 1, wherein the data elements are voxels (a 3D x-ray imaging system, such as a computed tomography imaging system, preferably a spectral 3D x-ray imaging system, para. 0010).
Regarding claim 9, Vogtmeier discloses the surgical method of claim 1, wherein the three-dimensional array is generated from a CT scan (para. 0010).
Regarding claim 10, Vogtmeier discloses the surgical method of claim 1, wherein each parameter value comprises a Hounsfield unit value (para. 0037).
Regarding claim 11, Vogtmeier discloses the surgical method of claim 1, wherein at least one of the anatomical features represents cortical bone of a bony structure and regions of cancellous bone interior of an exterior perimeter (the anatomical model is based on CT imaging information, wherein the anatomical model is fabricated based on Houndsfield unit information, e.g. by printing or otherwise fabricating with color information based on the Houndsfield values, e.g. more transparent for a region with a low Houndsfield unit value and darker for a region with a high Houndsfield unit value, para. 0037).
Regarding claim 12, Vogtmeier discloses the surgical method of claim 1, wherein selecting hardware for use in the surgical procedure on the subject based on the density of the bony anatomical structure illustrated by the display of the three-dimensional point cloud model of the bony anatomical structure further comprises selecting an interbody spacer (using medical imaging to fabricate anatomical inserts, para. 0019).
Regarding claim 13, Vogtmeier discloses the surgical method of claim 1, wherein selecting hardware for use in the surgical procedure on the subject based on the density of the bony anatomical structure illustrated by the display of the three-dimensional point cloud model of the bony anatomical structure further comprises selecting an expandable spinal implant (a bone insert or a replacement implant such as hip, knee or dental implants, para. 0020).
Regarding claim 14, Vogtmeier discloses the surgical method of claim 1, wherein selecting hardware for use in the surgical procedure on the subject based on the density of the bony anatomical structure illustrated by the display of the three-dimensional point cloud model of the bony anatomical structure further comprises selecting a cervical plate (replacement implant such as hip, knee or dental implants, para. 0020).
Regarding claim 15, Vogtmeier discloses the surgical method of claim 1, wherein selecting hardware for use in the surgical procedure on the subject based on the density of the bony anatomical structure illustrated by the display of the three-dimensional point cloud model of the bony anatomical structure further comprises selecting a screw (Examiner articulates that replacement implants such as hip, knee or dental implants, para. 0020, typically require screws).
Regarding claim 16, Vogtmeier discloses the surgical method of claim 15, wherein the screw is configured for support in an area of dense cancellous bone (anatomical model is fabricated based on Houndsfield unit information, e.g. by printing or otherwise fabricating with color information based on the Houndsfield values, e.g. more transparent for a region with a low Houndsfield unit value and darker for a region with a high Houndsfield unit value, para. 0037) of the bony anatomical structure (additional material information may also be of interest for anatomical models that are to be implanted, e.g. using the determined bone structure density to estimate the stability of the anatomical model, para. 0036.)
Regarding claim 17, Vogtmeier discloses the surgical method of claim 16, wherein the bony anatomical structure is a vertebral body (the medical imager, e.g. a CT imaging system, may be optimized to have maximum contrast for bone structures
versus tissue (optimized setting for kV and/or mA). Reconstruction and filtering parameters then may be optimized for best contrast at exactly the bone-to-tissue interface to enable precise segmentation and geometry extraction of the selected region of interest, para. 0027)
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to THOMAS J LETT whose telephone number is (571)272-7464. The examiner can normally be reached Mon-Fri 9-6 ET.
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/THOMAS J LETT/Primary Examiner, Art Unit 2611