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 .
Response to Arguments
Applicant’s arguments with respect to amended claims 1, 12, and 17 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Applicant’s arguments, see page 8, filed 28 January 2026, with respect to claim objection and 112 rejections have been fully considered and are persuasive in view of amendment. The 112 rejection and claim objection of 03 November 2025 has been withdrawn.
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 following rejection has been modified in view of applicant's arguments and/or amendments.
Claims 1-3, 5-9, and 11-12 are rejected under 35 U.S.C. 103 as being unpatentable over “Achatz et al.,” US 2017/0177827 (hereinafter Achatz) and “Niessen et al.,” US 2007/0274450 (hereinafter Niessen), and “Achatz et al.,” US 2020/0237326 (hereinafter Achatz 326), and further in view of “Pathak et al.,” US 2022/0175458 (hereinafter Pathak).
Regarding to claim 1, Achatz teaches a computer-implemented medical method of determining a position of a stimulation electrode ([0001] and [0028]), the method comprising the following steps comprising:
acquiring first medical image data that describes a first digital medical image of an anatomical body part (a digital image representing the medical image of the anatomical body part [0009]), and the stimulation electrode (electrode position data is relative position of electrode and acquired by medical image of anatomical body part, medical image of a real electrode relative to target anatomical structure in the medical image [0012]) ;
determining electrode position data based on the first medical image data, wherein the electrode position data describes a position of the stimulation electrode relative to the anatomical body part (electrode position data represents a relative position between a position of an electrode and a position of the anatomical body part of the patient in patient in medical image [0012], [0019]);
acquiring second digital medical image data, wherein the second digital medical image data describes a set of second digital medical images of the stimulation electrode (acquiring electrode image data describing a second medical image of the electrode [0015]);
Achatz does not explicitly teach acquiring second medical image data based on the electrode position data.
However, in the analogous field of endeavor in image guidance of surgical instruments, Niessen teaches acquisition of image at optimal position based on the position of an instrument ([0014]). Accordingly, when Achatz acquires second image data of electrode, Achatz can achieve optimal view of the image based on the position of the instrument from the first image as disclosed by Niessen ([0031]-[0032]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify acquisition of second image data as taught by Achatz to incorporate teaching of Niessen, as both are directed to image acquisition of instrument during medical procedure, and since determining imaging condition based on the positional data of instrument was well known in the art as taught by Niessen. One of ordinary skill in the art could have combined the elements as claimed by Achatz with no change in their respective functions, but using its position data of the electrode from the first image data, to acquire second image of the instrument, and the combination would have yielded nothing more than predictable results to one of ordinary skill in the art before the effective filing date of the claimed invention. The motivation would have been to optimal view of the desire object of interest obtained using imaging unit ([0014]), and there was reasonable expectation of success.
Achatz does not further disclose orientation data is determined in the image data and a rotational orientation.
However, in the analogous field of endeavor in image guidance of electrode, Achatz 326 discloses following limitations:
Electrode having asymmetric properties provided to the stimulation electrode by directional contacts of the stimulation electrode and/or by an asymmetric marker coupled to the stimulation electrode (orientation marker and directional contact [0025]; [0074]; Figure 2 shows electrode with directional contacts 8 and asymmetric marker 3)
determining electrode orientation data based on the second digital medical image data (rotational orientation of the electrode determined in tomographic image data [0025], [0075]), wherein the electrode orientation data describes a rotational orientation of the stimulation electrode around its longitudinal axis of the stimulation electrode (a rotational axis defined by the extension of the longitudinal axis of the electrode [0011])
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify image data of the electrode as taught by Achatz to incorporate teaching of Achatz 326, as all of them are directed to image acquisition of instrument during medical procedure, and since rotational orientation of the electrode around its longitudinal axis of the electrode was well known in the art as taught by Achatz 326. One of ordinary skill in the art could have combined the elements as claimed by Achatz with no change in their respective functions, but using the electrode image data to determine rotational orientation, and the combination would have yielded nothing more than predictable results to one of ordinary skill in the art before the effective filing date of the claimed invention. The motivation would have been to provide accurate measurement of rotational angular orientation of the electrode around its longitudinal axis ([0003]), and there was reasonable expectation of success.
Achatz, Niessen, and Achatz 326 do not explicitly disclose amended limitation of “determining electrode position data by determining a position of an artifact in the first medical image data representing an imaging response of the stimulation electrode having the asymmetric properties to imaging radiation used to generate the first medical image data.”
However, in the analogous field of endeavor in determining electrode orientation, Pathak teaches representation of CT image with artifacts from orientate marker of the DBS lead, and CT image with artifacts from segmented electrodes of a DBS lead, which are rotationally asymmetric ([0047]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify asymmetric marker as taught by Achatz 326 to incorporate teaching of Pathak, as both are directed to image acquisition of instrument during medical procedure, specifically for stimulation electrode with asymmetric marker, and since using imaging artifact was well known in the art as taught by Pathak. One of ordinary skill in the art could have combined the elements as claimed by Achatz 326 with no change in their respective functions, using CT imaging to reveal imaging artifacts, to acquire second image of the instrument, and the combination would have yielded nothing more than predictable results to one of ordinary skill in the art before the effective filing date of the claimed invention. The motivation would have been to determine estimation of DBS lead orientation ([0047]), and there was reasonable expectation of success.
Regarding to claims 2-3, 5-6, 9, and 11, Achatz, Niessen, Achatz 326 and Pathak together teach all limitations of claim 1 as discussed above.
Achatz 326 further teaches following limitations:
Of claim 2, wherein at least one of the first medical image data and/or the second digital medical image data comprises tomographic three-dimensional image data (tomographic image data in three dimensions [0023]; three-dimensional image corresponding to tomographic image data [0076])
Of claim 3, wherein at least one of the first medical image data and/or the second digital medical image data comprises radiographic two-dimensional image data (2D x-ray images/radiographs [0075])
Of claim 5, wherein the stimulation electrode comprises at least two directional mutually spaced part contacts (directional contacts 2 Fig. 2, slits forming spaces between the directional contacts and contacts are spaced apart [0074]), and further comprising using an image appearance of at least part of each of at least two spaces in between the at least two directional contacts in the set of second digital medical images is used to determine the rotational orientation described by the electrode orientation data (figures 3-4 show spaces created by slits between contacts as well as spaced apart contacts are shown in the images, claim 31).
Of claim 6, wherein the determining the electrode orientation data includes comprises determining, by the at least one processor and based on the first medical image data, an image appearance of the asymmetric marker ([0016] Figure 2 shows asymmetric marker and its appearance in the image in Figures 3-4), for example by at least one of:
segmenting an image appearance of the stimulation electrode in each of the plurality of first digital medical images (segmenting an image appearance of the electrode [0017]);
edge detecting of constituents of the plurality of first digital medical images (Edge detection [0018]); and/or
comparing the image appearance of the stimulation electrode in the set of second digital medical images to previously acquired and predetermined electrode template data describing constructional data of the stimulation electrode ([0019]).
Of claim 9, wherein further comprising optimizing an imaging parameter of a medical imaging apparatus based on at least one of the first medical image data or the set of second digital medical image data for generating third medical image data that describes a third medical image of the stimulation electrode (if more than one of the two-dimensional images is analyzed in the manner and it better fulfilment of the predetermined condition is determined for another one of the tow-dimensional images, then that other two-dimensional medical image is determined to be the optimal two-dimensional medical image [0022])
Of claim 11, wherein the generating the third medical image data comprises generating radiography and/or tomography two-or three- dimensional image data (Two-dimensional medical images taken with a C-arm radiography, x-ray tomography [0015]).
Regarding to claims 7-8, Achatz, Niessen, Achatz 326 and Pathak together teach all limitations of claim 1 as discussed above.
Niessen further teaches following limitations:
Of claim 7, determining at least one of the imaging direction at which the set of second digital medical images was generated is determined based on the first medical image data (direction in which imaging unit shall be moved to reach the desired position [0017])
Of claim 8, the determining the at least one imaging direction comprises determining an imaging direction that is perpendicular to the longitudinal axis of the stimulation electrode (perpendicular to the instrument [0032])
Regarding to claim 12, Achatz teaches a non-transient computer readable storage medium storing a computer program comprising instructions that, when the program is executed by a processor device of a computer, cause the computer to perform a method of determining a position of a stimulation electrode ([0001] and [0028]), the method comprising:
acquiring first medical image data that describes a first digital medical image of an anatomical body part (a digital image representing the medical image of the anatomical body part [0009]), and the stimulation electrode (electrode position data is relative position of electrode and acquired by medical image of anatomical body part, medical image of a real electrode relative to target anatomical structure in the medical image [0012]) ;
determining electrode position data based on the first medical image data, wherein the electrode position data describes a position of the stimulation electrode relative to the anatomical body part (electrode position data represents a relative position between a position of an electrode and a position of the anatomical body part of the patient in patient in medical image [0012], [0019]);
acquiring second digital medical image data, wherein the second digital medical image data describes a set of second digital medical images of the stimulation electrode (acquiring electrode image data describing a second medical image of the electrode [0015]);
Achatz does not explicitly teach acquiring second medical image data based on the electrode position data.
However, in the analogous field of endeavor in image guidance of surgical instruments, Niessen teaches acquisition of image at optimal position based on the position of an instrument ([0014]). Accordingly, when Achatz acquires second image data of electrode, Achatz can achieve optimal view of the image based on the position of the instrument from the first image as disclosed by Niessen ([0031]-[0032]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify acquisition of second image data as taught by Achatz to incorporate teaching of Niessen, as both are directed to image acquisition of instrument during medical procedure, and since determining imaging condition based on the positional data of instrument was well known in the art as taught by Niessen. One of ordinary skill in the art could have combined the elements as claimed by Achatz with no change in their respective functions, but using its position data of the electrode from the first image data, to acquire second image of the instrument, and the combination would have yielded nothing more than predictable results to one of ordinary skill in the art before the effective filing date of the claimed invention. The motivation would have been to optimal view of the desire object of interest obtained using imaging unit ([0014]), and there was reasonable expectation of success.
Achatz does not further disclose orientation data is determined in the image data and a rotational orientation.
However, in the analogous field of endeavor in image guidance of electrode, Achatz 326 discloses following limitations:
Electrode having asymmetric properties provided to the stimulation electrode by directional contacts of the stimulation electrode and/or by an asymmetric marker coupled to the stimulation electrode (orientation marker and directional contact [0025]; [0074]; Figure 2 shows electrode with directional contacts 8 and asymmetric marker 3)
determining electrode orientation data based on the second digital medical image data (rotational orientation of the electrode determined in tomographic image data [0025], [0075]), wherein the electrode orientation data describes a rotational orientation of the stimulation electrode around its longitudinal axis of the stimulation electrode (a rotational axis defined by the extension of the longitudinal axis of the electrode [0011])
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify image data of the electrode as taught by Achatz to incorporate teaching of Achatz 326, as all of them are directed to image acquisition of instrument during medical procedure, and since rotational orientation of the electrode around its longitudinal axis of the electrode was well known in the art as taught by Achatz 326. One of ordinary skill in the art could have combined the elements as claimed by Achatz with no change in their respective functions, but using the electrode image data to determine rotational orientation, and the combination would have yielded nothing more than predictable results to one of ordinary skill in the art before the effective filing date of the claimed invention. The motivation would have been to provide accurate measurement of rotational angular orientation of the electrode around its longitudinal axis ([0003]), and there was reasonable expectation of success.
Achatz, Niessen, and Achatz 326 do not explicitly disclose amended limitation of “determining electrode position data by determining a position of an artifact in the first medical image data representing an imaging response of the stimulation electrode having the asymmetric properties to imaging radiation used to generate the first medical image data.”
However, in the analogous field of endeavor in determining electrode orientation, Pathak teaches representation of CT image with artifacts from orientate marker of the DBS lead, and CT image with artifacts from segmented electrodes of a DBS lead, which are rotationally asymmetric ([0047]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify asymmetric marker as taught by Achatz 326 to incorporate teaching of Pathak, as both are directed to image acquisition of instrument during medical procedure, specifically for stimulation electrode with asymmetric marker, and since using imaging artifact was well known in the art as taught by Pathak. One of ordinary skill in the art could have combined the elements as claimed by Achatz 326 with no change in their respective functions, using CT imaging to reveal imaging artifacts, to acquire second image of the instrument, and the combination would have yielded nothing more than predictable results to one of ordinary skill in the art before the effective filing date of the claimed invention. The motivation would have been to determine estimation of DBS lead orientation ([0047]), and there was reasonable expectation of success.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Achatz, Niessen, Achatz 326 and Pathak as applied to claim 9 above, and further in view of “Homan et al.,” US 2008/0171936 (hereinafter Homan).
Regarding to claim 10, Achatz, Niessen, Achatz 326 and Pathak together teach all limitations of claim 9 as discussed above.
Niessen further teaches optimizing the imaging parameter based on the position of the instrument (optimal view of the desired object of interest, optimal position parameters [0014]), but does not further disclose optimizing at least one of an imaging radiation dose, a field of view, a focus, and/or a collimator setting.
However, in the analogous field of endeavor in image guidance of an instrument within the patient’s body, Homan teaches imaging an instrument moving within the body, using a rotational X-ray device, like CT or C-arm device with adjustable projection geometry comprising the projection direction, shape of the field of view, and/or the source-image-distance ([0005]-[0006]) and optimal focus ([0038]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify image data of the electrode as taught by Achatz and Niessen to incorporate teaching of Homan, as all of them are directed to X-ray/CT image acquisition of instrument during medical procedure, and adjusting field of view was well known in the art as taught by Homan. One of ordinary skill in the art could have combined the elements as claimed by Achatz with no change in their respective functions, but adjusting field of view of the imaging system/method, and the combination would have yielded nothing more than predictable results to one of ordinary skill in the art before the effective filing date of the claimed invention. The motivation would have been to provide optimal focus and optimal imaging of the instrument ([0038]), and there was reasonable expectation of success.
Claims 17-18 are rejected under 35 U.S.C. 103 as being unpatentable over “Achatz et al.,” US 2020/0237326 (hereinafter Achatz 326) and “Pathak et al.,” US 2022/0175458 (hereinafter Pathak).
Regarding to claim 17, Achatz 326 teaches a medical system comprising:
at least one computer comprising a processor and a non-transitory storage medium storing a computer program ([0051] and [0055]) thereon, wherein the processor is configured to determine, by the at least one processor, an image appearance of a rotationally asymmetric marker (Figure 2 marker 3 shows asymmetric properties) by comparing an image appearance of a stimulation electrode in a set of second digital medical images having asymmetric properties provide to the stimulation electrode by the rotationally asymmetric orientation marker coupled with the stimulation electrode (orientation marker and directional contact [0025]; [0074]; Figure 2 shows electrode with directional contacts 8 and asymmetric marker 3) to previously acquired and predetermined electrode template data describing constructional data of the stimulation electrode (comparing the image appearance of the electrode in the medical images to previously acquired and predetermined electrode template data [0019]);
a non-transitory electronic data storage device ([0043]-[0044]) storing at least the electrode template data ([0058]); and
a first medical imaging apparatus configured to generate the first medical image data, data; ([0015])
a second medical imaging apparatus configured to generate the second digital medical image data ([0026]),
wherein the at least one computer is operably coupled to
the first medical imaging apparatus for acquiring, from the first medical imaging apparatus, the first medical image data ([0015]);
the second medical imaging apparatus for acquiring, from the second medical imaging apparatus, the second digital medical image data ([0026])
the at least one non-transitory electronic data storage device for acquiring, from the data storage device, at least the electrode template data (previously acquired template data [0020]-[0021]; acquiring data from a data storage medium [0058]).
Achatz 326 already teaches previously acquired template data as set forth above, and discloses acquiring data from a data storage medium, thus, Achatz can store its template data in the storage medium, to retrieve and acquire the stored data so the data can be used for comparison the image appearance of the electrode ([0019] and [0058]).
Achatz 326 does not explicitly disclose amended limitation of “image data based on orientation marker data determined based on a position of an artifact in the first medical image data representing an imaging response of the stimulation electrode having the asymmetric properties to imaging radiation used to generate the first medical image data.”
However, in the analogous field of endeavor in determining electrode orientation, Pathak teaches representation of CT image with artifacts from orientate marker of the DBS lead, and CT image with artifacts from segmented electrodes of a DBS lead, which are rotationally asymmetric ([0047]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify asymmetric marker as taught by Achatz 326 to incorporate teaching of Pathak, as both are directed to image acquisition of instrument during medical procedure, specifically for stimulation electrode with asymmetric marker, and since using imaging artifact was well known in the art as taught by Pathak. One of ordinary skill in the art could have combined the elements as claimed by Achatz 326 with no change in their respective functions, using CT imaging to reveal imaging artifacts, to acquire second image of the instrument, and the combination would have yielded nothing more than predictable results to one of ordinary skill in the art before the effective filing date of the claimed invention. The motivation would have been to determine estimation of DBS lead orientation ([0047]), and there was reasonable expectation of success.
Regarding to claim 18, Achatz 326 and Pathak together teach all limitations of claim 17 as discussed above.
Achatz 326 further teaches wherein the first medical imaging apparatus and the second medical imaging apparatus are identical (radiograph [0015] and [0026]).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/PATRICIA J PARK/Primary Examiner, Art Unit 3798