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 .
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Objections
Claim 14 is objected to because of the following informalities: in line 6 and again in line 7, “fulfils” should apparently read --fulfills--. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 5-11, 13, 14, 17, and 21 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 5 recites the limitation "an anatomical body part" in line 3. It is not clear if this is intended to refer to the anatomical body part recited in claim 1 or to a separate body part. If the former is intended, the limitation should read --the anatomical body part--.
Claim 5 also recites the limitation “a thorax of the patient’s chest surface” in lines 4-5. It is not clear what is meant by this limitation; a thorax is generally synonymous with a chest for humans.
Claim 6 recites the limitation “the acquiring the first and second image data with the point cloud generating device” in lines 2-3. There is insufficient antecedent basis for this limitation in the claim; claim 1 recites acquiring the first and second image data that describes first and second images taken with the point cloud generating device; it does not recite the step of acquiring this data with the point cloud generating device.
Claim 7 recites the limitation “the acquiring the tomography data with the tomograph” in line 2. There is insufficient antecedent basis for this limitation in the claim; claim 1 recites acquiring the tomography data that describes a tomographic image taken with the tomograph; it does not recite the step of acquiring this data with the tomograph.
Claim 8 recites the limitation "an outer contour" in line 5. It is not clear if this is intended to refer to the same outer contour recited in lines 3-4 or to a separate outer contour.
Claim 8 also recites the limitation "first image" in line 8. It is not clear if this is intended to refer to the first image recited in claim 1 or to a separate image. If the former is intended, the limitation should read --the first image--.
Claim 10 recites the limitation “the outer contour” in line 4. It is not clear which of the outer contours recited in claim 8 this refers to.
Claim 11 recites the limitation “the patient support device” in lines 4-5. There is insufficient antecedent basis for this limitation in the claim.
Claim 11 also recites the limitation “at least substantially planar couch” in line 5. The term “substantially” is a relative term which renders the claim indefinite. The term is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The metes and bounds of “substantially planar” are not readily determinable.
Regarding claim 13, the phrase "such as" (in line 4) renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim 14 recites the limitation "an outer contour" in lines 2-3. It is not clear if this is intended to refer to the same outer contour recited in claim 8 or to a separate outer contour.
Claim 14 also recites the limitation "the contour" in line 5 (and again in line 7). It is not clear which contour this is referring to.
Regarding claim 14, the phrase "for example" (in the last line) renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claims 9, 12, and 14 are rejected by virtue of their dependence upon a rejected base claim.
Claim 17 recites the limitations “the associated patient treatment device” in lines 3-4, “the anatomical body part” in line 5, and “the patient” in line 6. There is insufficient antecedent basis for these limitations in the claim.
Claim 20 recites the limitation “the transformed first image data” in the last two lines. There is insufficient antecedent basis for this limitation in the claim.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 2 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 2 recites that the first and second breathing conditions are different breathing conditions. However, this is already recited by claim 1, which recites that the first breathing condition is a free-breathing condition and the second breathing condition is a DIBH and/or a DEBH condition. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-8, 15, 17, and 21 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Berlinger et al. (U.S. Pub. No. 2019/0156497 A1; hereinafter known as “Berlinger”).
Regarding claim 1, Berlinger discloses a computer-implemented medical method of transforming a first medical image dataset describing an anatomical body part of a patient into a reference system of a second medical image dataset describing the anatomical body part (Abstract; Fig. 1), the method comprising: acquiring first image data that describes a first image of the anatomical body part taken with a point cloud generating device under a first breathing condition of the patient comprising a free-breathing condition of the patient ([0009]; [0011]; [0022]-[0023]); acquiring second image data that describes a second image of the anatomical body part taken with the point cloud generating device under a second breathing condition of the patient comprising one or more of a deep inspiration breath-hold condition of the patient and/or a deep expiration breath-hold condition of the patient ([0009]; [0011]; [0022]-[0023]); acquiring tomography data that describes a tomographic image of the anatomical body part taken with a tomograph under the second breathing condition of the patient ([0013]; [0061]); determining transformation data based on the second image data and the tomography data, wherein the transformation data describes a spatial transformation between a point cloud reference system in which positions in the second image are defined and a tomography reference system in which positions in the tomographic image are defined, and determining transformed first image data based on the first image data and the transformation data, wherein the transformed first image data describes a transformation of the first image into the tomography reference system ([0009]; [0011]; [0014]-[0017]; [0047]; [0061]).
Regarding claim 2, Berlinger discloses that the first breathing condition and the second breathing condition are different breathing conditions ([0009]; [0011]; free-breathing vs. DIBH).
Regarding claim 3, Berlinger discloses that the determining the transformed first image data comprises determining the transformed first image data by applying the spatial transformation between the point cloud reference system and the tomography reference system to the first image ([0009]; [0011]; [0014]-[0017]; [0047]; [0061]).
Regarding claim 4, Berlinger discloses that the determining the transformation data comprises determining the transformation data by matching, by fusing, the second image data with the tomography data ([0015]).
Regarding claim 5, Berlinger discloses that the acquiring the first and second image data comprises acquiring first and second image data of an anatomical body part comprising an outer surface of the patient's body, comprising an anterior surface of a thorax of the patient's chest surface ([0012]).
Regarding claim 6, Berlinger discloses that the acquiring the first and second image data with the point cloud generating device comprises acquiring the first and second image data with at least one of an infrared camera, a laser scanner comprising a three-dimensional laser scanner, a range camera, a depth camera, a time-of-flight camera, a light detection and ranging camera, and/or a stereo camera ([0023]).
Regarding claim 7, Berlinger discloses that the acquiring the tomography data with the tomograph comprises acquiring the tomography data using a computed x-ray tomography imaging device ([0009]; [0012]-[0013]; [0056]).
Regarding claim 8, Berlinger discloses determining, based on the tomography data, tomography contour data describing an outer contour of the anatomical body part, wherein the first image describes an outer contour of the anatomical body part, and wherein the determining the transformation data comprises determining the transformation data based on the second image data and the tomography contour data, by matching the outer contour described by first image with the outer contour described by the tomography contour data ([0012]; [0015]; [0023]).
Regarding claim 15, Berlinger discloses determining, based on the transformed first image data, patient positioning data describing at least one control command for positioning the patient relative to an associated radiation treatment device ([0024]-[0027]).
Regarding claim 17, Berlinger discloses a non-transient computer-readable storage medium storing a program thereon, wherein execution of the program by an associated processor of an associated radiation treatment device causes the associated patient treatment device to perform a method (Abstract; [0028]-[0030]) comprising: acquiring first image data that describes a first image of the anatomical body part taken with a point cloud generating device under a first breathing condition of the patient comprising a free-breathing condition of the patient ([0009]; [0011]; [0022]-[0023]); acquiring second image data that describes a second image of the anatomical body part taken with the point cloud generating device under a second breathing condition of the patient comprising one or more of a deep inspiration breath-hold condition of the patient and/or a deep expiration breath-hold condition of the patient ([0009]; [0011]; [0022]-[0023]); acquiring tomography data that describes a tomographic image of the anatomical body part taken with a tomograph under the second breathing condition of the patient ([0013]; [0061]); determining transformation data based on the second image data and the tomography data, wherein the transformation data describes a spatial transformation between a point cloud reference system in which positions in the second image are defined and a tomography reference system in which positions in the tomographic image are defined, and determining transformed first image data based on the first image data and the transformation data, wherein the transformed first image data describes a transformation of the first image into the tomography reference system ([0009]; [0011]; [0014]-[0017]; [0047]; [0061]).
Regarding claim 21, Berlinger discloses a system (Abstract), comprising: at least one computer comprising a processor ([0028-[0030]); at least one electronic data storage device operatively coupled with the processor and storing first image data, second image data and tomography data ([0028]-[0037]), wherein the first image data describes a first image of an anatomical body part of an associated patient taken with a point cloud generating device under a first breathing condition of the patient comprising a free-breathing condition of the patient ([0009]; [0011]; [0022]-[0023]), wherein the second image data describes a second image of the anatomical body part taken with the point cloud generating device under a second breathing condition of the patient comprising one or more of a deep inspiration breath-hold condition of the patient and/or a deep expiration breath-hold condition of the patient ([0009]; [0011]; [0022]-[0023]); and a radiation treatment device operable to carry out irradiation treatment on the patient ([0038]), wherein the at least one computer is operably coupled to the at least one electronic data storage device for acquiring, from the at least one electronic data storage device the first image data, the second image data and the tomography data ([0028]-[0037]; [0061]), and the radiation treatment device for issuing a control signal to the radiation treatment device for controlling an operation of the radiation treatment device to control a position of the radiation treatment device relative to the anatomical body part, on a basis of the transformed first image data ([0024]-[0027]).
Claim Rejections - 35 USC § 103
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.
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.
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.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Berlinger as applied to claim 8 above, and further in view of Li et al. (U.S. Pub. No. 2017/0132791 A1; hereinafter known as “Li”). Berlinger discloses the invention as claimed, see rejection supra, but fails to disclose that the determining the tomography contour data comprises determining the tomography contour data by applying a marching cube algorithm to the tomography data and considering a greyscale threshold value for determining a boundary between the anatomical body part and the atmosphere surrounding the anatomical body part. Li discloses a similar method for reconstructing a 3D medical image (Abstract) comprising determining tomography contour data by applying a marching cube algorithm to tomography data and considering a greyscale threshold value for determining a boundary between an anatomical body part and an atmosphere surrounding the anatomical body part in order to reconstruct a 3D medical image for a region of interest ([0044]-[0046]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Berlinger by applying the algorithm and threshold values, as taught by Li, as this is a known effective method for reconstructing tomography contour data for a region of interest.
Claims 13 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Berlinger as applied to claims 1 and 8 above, and further in view of Regensburger (DE 102019202058 A1).
Regarding claim 13, Berlinger discloses the invention as claimed, see rejection supra, but fails to disclose determining transformation quality data describing a quality of the transformation data by determining a similarity measure such as a root mean square error of the spatial transformation between the point cloud reference system and the tomography reference system. Regensburger discloses a similar method (Abstract) comprising determining transformation quality data describing a quality of transformation data by determining a similarity measure of a spatial transformation between the reference systems in order to minimize the required irradiation dose (determines degree of uncertainty of the registration between image datasets). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Berlinger by determining a similarity measure of the spatial transformation between the point cloud reference system and the tomography reference system, as taught by Regensburger, in order to minimize the required irradiation dose.
Regarding claim 14, Berlinger discloses the invention as claimed, see rejection supra, and further discloses determining, based on the second image data, point cloud contour data describing an outer contour of the anatomical body part; and determining, based on the point cloud contour data and the tomography contour data, hybrid surface data describing a merging of at least a part of the contour described by the point cloud contour data with at least a part of the contour described by the tomography contour data ([0012]; [0015]; [0023]). Berlinger fails to disclose that the respective contour data fulfill a predetermined quality criterion. Regensburger discloses a similar method (Abstract) comprising determining transformation quality data that fulfills a predetermined criterion, for example quality criterion, in order to minimize the required irradiation dose (determines degree of uncertainty of the registration/fusion between image datasets). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Berlinger so that that the contour data fulfills a predetermined quality criterion, as taught by Regensburger, in order to minimize the required irradiation dose.
Allowable Subject Matter
Claims 10-12 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: regarding claim 10, while atlas data and greyscale thresholding are both known in the prior art, none of the prior art of record teaches or reasonably suggests determining such tomography contour data based on the atlas data describing a 3D digital model of the anatomical body part, segmenting the outer contour in the atlas data based on the greyscale threshold value, and matching by fusing the segmented outer contour with the tomographic image. Regarding claims 11 and 12, while such patient support devices and registration/transformations that include such devices are known in the prior art, none of the prior art of record teaches or reasonably suggests determining patient support device plane data based on such first or second image data and determining the transformed first image data further based on this patient support device plane data.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to THADDEUS B COX whose telephone number is (571)270-5132. The examiner can normally be reached M-F 9am-6pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jason M. Sims can be reached at (571)272-7540. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/THADDEUS B COX/Primary Examiner, Art Unit 3791
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