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 .
Claim Objections
Claim 15 is objected to because of the following informalities:
Claim 15 line 1, limitation “detecting a bone fracture” should read “detecting the bone fracture”.
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.
Claim 7 is 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 7 recites the limitation "the medically optimal 3D orientation of the reference body and the implant has been created" in lien 1 – 2. There is insufficient antecedent basis for this limitation in the claim. The parent claim 6 only recites “create a medically optimal 3D orientation of the reference body”. There is no creation of a medically optimal 3D orientation of the implant.
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.
Claim 1 – 6, 8 – 11 and 16 – 18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Blau et al. (WO 2014/048447 A1; published on 04/03/2014) (hereinafter "Blau").
Regarding claim 1, Blau discloses a method of treating a bone fracture ("The flow-chart in Fig. 1 illustrates the principle of the steps performed in accordance with one embodiment of the disclosed method." Page 7; "For example, the method may firstly be performed on a healthy counterpart of a fractured bone to determine an anatomically correct angle related to one patient, and may secondly be performed on the fractured bone to support the attempt to correctly arrange parts of the fractured bone." Page 8) comprising:
taking a 2D image of an implant, a reference body, and an anatomical structure with an imaging device ("In step S21 , an image of the bone is received." Page 7; “… each of the images received in steps S11, S21 or S31, may be any image ... i.e. a 3D image or a 2D image of at least the respective section of the bone, wherein the 2D image should additionally show a reference body.” Page 8; "Figure 3 is an image generated in an anterior to posterior direction ... in which a bone nail 20 ..." Page 9); and
detecting the reference body in the 2D image ("… wherein the 2D image further includes a visualization of a reference body." Page 3; "Due to a specific 3D distribution of the elements 64 at or within the adjusting device 62, a projection of the elements onto an imaging plane will lead to a unique 2D distribution ..." Page 12), wherein the reference body is in a fixed position relative to the anatomical structure ("… the reference body is adapted to be fixedly connected to the bone." Page 3).
Regarding claim 2, Blau discloses all claim limitations, as applied in claim 1, and further discloses wherein the reference body is in the fixed position adjacent to the anatomical structure ("... the reference body may be at least a part of an implant. In other words, an implant which is adapted to be fixed at or in a bone may comprise elements which can be identified in an image of the bone or at least a section of the bone …" Page 4).
Regarding claim 3, Blau discloses all claim limitations, as applied in claim 1, and further discloses wherein the reference body is in the fixed position on the anatomical structure ("... the reference body may be at least a part of an implant. In other words, an implant which is adapted to be fixed at or in a bone may comprise elements which can be identified in an image of the bone or at least a section of the bone …" Page 4).
Regarding claim 4, Blau discloses all claim limitations, as applied in claim 1, and further discloses wherein the reference body is in the fixed position inside the anatomical structure ("... the reference body may be at least a part of an implant. In other words, an implant which is adapted to be fixed at or in a bone may comprise elements which can be identified in an image of the bone or at least a section of the bone …" Page 4).
Regarding claim 5, Blau discloses all claim limitations, as applied in claim 1, and further discloses detecting a first set of reference points in the 2D image ("Further shown in figure 6 is a plurality of elements 64 forming an example of a reference body. Each of these elements 64 is a small radiopaque sphere so that each element is shown as a point in an X-ray image. Due to a specific 3D distribution of the elements 64 at or within the adjusting device 62, a projection of the elements onto an imaging plane will lead to a unique 2D distribution ..." Page 12).
Regarding claim 6, Blau discloses all claim limitations, as applied in claim 5, and further discloses determining based only on the 2D image whether the first set of reference points create a medically optimal 3D orientation of the reference body ("… so that an actual 3D orientation of the reference body can be determined based on the projected 2D distribution. Knowing the 3D orientation of the reference body allows the determination of an actual direction of for example a tangent line at the condyles." Page 12).
Regarding claim 8, Blau discloses all claim limitations, as applied in claim 1, and further discloses creating a 3D orientation of the reference body based only on the 2D image in that a structure of the reference body allows a determination of the 3D orientation of the reference body based only on the 2D image ("… a projection of the elements onto an imaging plane will lead to a unique 2D distribution so that an actual 3D orientation of the reference body can be determined based on the projected 2D distribution.” Page 12).
Regarding claim 9, Blau discloses all claim limitations, as applied in claim 8, and further discloses determining an actual axis of delivery of a bone screw though an opening extending through the implant ("Fixedly attached to the bone nail 20 is an aiming device 60 with a sleeve 70 for an insertion of a further locking screw to be inserted in the distal section 14 of the femur." Page 9; here the axis of sleeve 70 or aiming device 60 is the actual axis of delivery of the further locking screw).
Regarding claim 10, Blau discloses all claim limitations, as applied in claim 9, and further discloses determining an optimal axis of delivery of the bone screw through the opening such that the optimal axis of delivery guides the bone screw toward a medically optimal location ("By means of a single image, like that exemplarily shown in figure 6, it is possible to determine a second projected vector V2." Page 12; see Fig.6, it is shown in the figure that the vector V2 and the distance D together define the desired insertion axis for "further locking screw").
Regarding claim 11, Blau discloses all claim limitations, as applied in claim 10, and further discloses moving the implant such that the optimal axis of delivery and the actual axis of delivery coincide ("… including an adjusting element 62 for adjusting a height for inserting a locking screw through a bore in the leading end of a bone nail 20, and a sleeve 70 for facilitating the insertion of a locking screw." Page 12).
Regarding claim 16, Blau discloses all claim limitations, as applied in claim 1, and further discloses positioning the reference body adjacent to the implant (“For example, a reference body may be directly attached at an implant or may be indirectly coupled to an implant …” Page 4).
Regarding claim 17, Blau discloses all claim limitations, as applied in claim 11, and further discloses wherein the moving step includes moving the implant such that the optimal axis of delivery extends into a femoral head ("Fixedly attached to the bone nail 20 is an aiming device 60 with a sleeve 70 for an insertion of a further locking screw to be inserted in the distal section 14 of the femur." Page 9).
Regarding claim 18, Blau discloses all claim limitations, as applied in claim 1, and further discloses comparing the 2D image with information received from a database ("Due to a specific 3D distribution of the elements 64 at or within the adjusting device 62, a projection of the elements onto an imaging plane will lead to a unique 2D distribution so that an actual 3D orientation of the reference body can be determined based on the projected 2D distribution." Page 12; in computer system, a database is a must-have for storing values in calculation, this is inherent element for data/image processing).
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.
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 7 is rejected under 35 U.S.C. 103 as being unpatentable over Blau, as applied in claim 6, and further in view of Selover et al. (US 2014/0275981 A1; published on 09/18/2014) (hereinafter "Selover").
Regarding claim 7, Blau teaches all claim limitations, as applied in claim 6, except alerting an operator that the medically optimal 3D orientation of the reference body and the implant has been created.
However, in the same field of endeavor, Selover teaches alerting an operator that the medically optimal 3D orientation of the reference body and the implant has been created ("Based on whether the trajectory is aligned with the predetermined trajectory, e.g., based on the determination made by the determination module 202, the notification module 204 can be configured to cause the notification unit 210 to provide a notification indicating the alignment, or misalignment, of the trajectory with the predetermined trajectory." [0049]).
It would have been prima facie obvious to one ordinary skilled in the art before the effective filing date of the invention to modify the robotic surgical system as taught by Blau with the notification module as taught by Selover. Providing notification to surgeon is a typical process during surgical procedure, doing so it "can help provide very precise positioning of the robotically-controlled instrument(s) and can facilitate human notification and correction of any deviations of the robotically-controlled instrument(s) from the predetermined trajectory" (see Selover; [0035]).
Claim 12 – 14 are rejected under 35 U.S.C. 103 as being unpatentable over Blau, as applied in claim 8, and further in view of Fichtinger et al. (US 2008/0262345 A1; published on 10/23/2008) (hereinafter "Fichtinger").
Regarding claim 12, Blau teaches all claim limitations, as applied in claim 8, except wherein the creating step includes projecting a first x-ray pattern from the 2D image on a first projection surface to form a pattern of projection points.
However, in the same field of endeavor, Fichtinger teaches wherein the creating step includes projecting a first x-ray pattern from the 2D image on a first projection surface to form a pattern of projection points ("First imager 115 may be a C-arm fluoroscope ... then the first imager 115 may acquire multi-angle imagery without having to be repositioned." [0052]; see Fig.2; "At the completion of step 330, the desired number of C-arm images from first imager 115 have been acquired, registered according to their own unique orientation, and stored. Again, FIG. 2 illustrates two images 210 of features 106 on fiducial device 105 acquired by first imager 115 at multiple angles. As illustrated, each image is at a different orientation, and each provides a unique image of features 106." [0105]; see Fig.3; "The result of the segment fiducial step 410 is a segmented projection of features 106 in the two-dimensional coordinate frame of first imager 115. The segmented projection may include a set of points in the two-dimensional coordinate frame of first imager 115 ..." [0080]).
It would have been prima facie obvious to one ordinary skilled in the art before the effective filing date of the invention to modify the reference body orientation calculation as taught by Blau with the detailed algorithm as taught by Fichtinger. Dosing so would make it possible to provide "improved localization of surgically implanted objects in real time" (see Fichtinger; [0017]).
Regarding claim 13, Blau in view of Fichtinger teaches all claim limitations, as applied in claim 12, and Fichtinger further teaches measuring a distance between a point of the pattern of projection points and another point of the pattern of projection points ("In step 435, the software retrieves the data values corresponding to the C-arm image acquired by first imager 115, and the estimated or “fake” image, and computes a Euclidean distance or Euclidean error function. The Euclidean distance is a matrix containing vectors between the corresponding points, lines, and ellipses of the acquired and estimated image." [0082]).
It would have been prima facie obvious to one ordinary skilled in the art before the effective filing date of the invention to modify the reference body orientation calculation as taught by Blau with the detailed algorithm as taught by Fichtinger. Dosing so would make it possible to provide "improved localization of surgically implanted objects in real time" (see Fichtinger; [0017]).
Regarding claim 14, Blau in view of Fichtinger teaches all claim limitations, as applied in claim 13, and Fichtinger further teaches comparing the measured distance with a predetermined distance within a database ("In step 445, the software compares the Euclidean distance with a pre-determined error threshold. If the Euclidean distance, which corresponds to the error in the pose estimation, is sufficiently small, the software stores the new pose estimation values as the final pose estimation." [0092]; in computer system, a database is a must-have for storing values in calculation, this is inherent element for data/image processing).
It would have been prima facie obvious to one ordinary skilled in the art before the effective filing date of the invention to modify the reference body orientation calculation as taught by Blau with the detailed algorithm as taught by Fichtinger. Dosing so would make it possible to provide "improved localization of surgically implanted objects in real time" (see Fichtinger; [0017]).
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Blau, as applied in claim 1, and further in view of Leow et al. (US 2007/0274584 A1; published on 11/29/2007) (hereinafter "Leow").
Regarding claim 15, Blau teaches all claim limitations, as applied in claim 1, and Blau further implies detecting a bone fracture in the 2D image ("… i.e. a distal section of a bone, i.e. a femur 10 is determined, with a fracture F in the shaft of the femur 10." Page.9; Fig.3; it is implied that fracture is detected and identified, so that the following steps of procedure can be performed based on the information of fracture F).
In addition, Leow explicitly teaches detecting a bone fracture in the 2D image ("The method of detecting fractures in the example embodiment can be divided into 3 stages: {1} extraction of approximate contour of the bone of interest in the x-ray image, {2} extraction of features from the x-ray image, and {3} classification of the bone based on the extracted features." [0064]).
It would have been prima facie obvious to one ordinary skilled in the art before the effective filing date of the invention to modify the x-ray image based bone fracture procedure as taught by Blau with the fracture detection method as taught by Leow. Doing so would make it possible that "both fracture detection rate and classification accuracy can be improved significantly" (see Leow; [0159]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHAO SHENG whose telephone number is (571)272-8059. The examiner can normally be reached Monday to Friday, 8:30 am to 5:00 pm.
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/CHAO SHENG/ Primary Examiner, Art Unit 3797