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 Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claim 20 is rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim does not fall within at least one of the four categories of patent eligible subject matter because the broadest reasonable interpretation of the “program storage medium” of Claim 20 encompasses signal per se. It is suggested that Claim 20 be amended to recite a non-transitory medium for program storage.
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, 12-14 and 16-18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kim et al (US 20190274762 A1; hereafter Kim).
With regard to Claim 1, Kim discloses a medical apparatus (surgical navigation system 1) comprising:
a navigation device (electromagnetic wave generator 11) for detecting at least one medical marking device (Kim, Para 0049; “… by the electromagnetic wave generated from the electromagnetic wave generator 11, positional information of the electromagnetic sensor may be obtained.”);
a data processing device (the information processor) for processing position data of the navigation device (positional information), wherein a position of the at least one medical marking device is determinable (Kim, Para 0051; “… the information processor may obtain positional information of the PSI 13 when the second detector 131 receives the electromagnetic wave …”); and
a storage device (a storage device is intrinsically available for storing the CT images and the 3D object model) in which a model data set with spatial representation of a bone is storable (Kim, Para 0039; “… in step S101, an operator obtains a computed tomography (CT) image from an object and generates a three-dimensional (3D) object model from the obtained CT image … the object may be construed as indicating a pelvis, a femur, a tibia …”), wherein the model data set comprises a piece of characteristic information (Kim, Para 0040; “In step S102, the operator manufactures a 3D-shape patient-specific surgical guide instrument … based on the 3D object model.”; Para 0041; “In step S103, the operator dislocates the femur from the pelvis, and inserts the femoral PSI into the head of the femur.”. In these disclosures, by removing the femur and inserting the femoral PSI, the 3D object model contains position information of the femoral PSI) characterizing a piece of reference position information of a reference element (femoral PSI, or more specifically in Para 0040; “a femoral PSI including a concave groove whose shape corresponds to a shape of a head or neck of the femur”) arranged in a defined spatial position on the bone (Kim, Para 0041; “In step S103, the operator dislocates the femur from the pelvis, and inserts the femoral PSI into the head of the femur.”),
wherein the reference element is an implant (Kim, Para 0040; “the operator may manufacture a femoral PSI …”; Para 0041; “… inserts the femoral PSI into the head of the femur”), and
wherein the data processing device is configured and programmed to:
provide a reference coordinate system (Kim, Para 0052; “… a positional relationship between a position of the surgical site A and a position of the surgical instrument 14 may be obtained as the first detector 121 and the third detector 141 detect the position of the surgical site A and the position of the surgical instrument 14, respectively. That is, relative positional information of the surgical site A and the surgical instrument 14 may be obtained.” According to this disclosure, other positions such as those of surgical instruments during surgery are determined relative to the position determined by the first detector 121, so information of the first detector 121 provides a reference coordinate system) based on position data of a first marking device of the at least one medical marking device (Kim, Para 0050; “The first detector 121 may include an inertial sensor to indicate a position of the surgical site of the object.”), the first marking device arranged in a first defined spatial position relative to the bone (Kim, Para 0050; “The first detector 121 may be attached to a surgical site of an object and detect a position attached to the surgical site. … the first detector 121 may be attached to an acetabular margin of the acetabulum A”),
determine a piece of characteristic information characterizing a position of the reference element (PSI 13) in the reference coordinate system (Kim, Para 0051; “when the PSI 13 is inserted in the surgical site A, the second detector 131 may detect a position in which the PSI 13 is inserted … the PSI 13 may be temporarily used before the surgical operation is performed to register a position of the surgical site A at which the first detector 121 is arranged, and not be used during the operation”) based on position data obtained by a second marking device of the at least one medical marking device (Kim, Para 0051; “The second detector 131 may receive the electromagnetic wave generated from the electromagnetic wave generator 11, and detect a position of a PSI 13.”. Here the disclosed second detector 131 corresponds to the claimed second marking device. The other example is the second detector 231 in Fig. 8, as cited below),
bring the position of the reference element in the reference coordinate system (“coordinates of an actual model”, which is determined based on detector 131 or 231) into agreement with the reference position information in the model data set (“the 3D object model”, and more specifically, the part of the 3D object model that corresponds to the femur in this example)( Kim, Para 0042; “In step S104, the operator performs registration between the femoral PSI and the 3D object model … Here, the registration refers to matching coordinates of an actual model and coordinates of a virtual model …”), and
register the model data set in the reference coordinate system with regard to an overlap of the model data set and the bone (Kim, Para 0042; “… performs registration between the femoral PSI and the 3D object model … the registration refers to a processing method that geometrically aligns two or more images to overlap the images”. Examples are demonstrated in Fig. 3 for the pelvis, and in the cited Fig. 8 for the femur).
Fig. 8 of Kim
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With regard to Claim 2, Kim discloses the medical apparatus according to claim 1, further comprising an X-ray device, wherein the model data set is creatable using the X-ray device (Kim, Para 0039; “…in step S101, an operator obtains a computed tomography (CT) image from an object and generates a three-dimensional (3D) object model from the obtained CT image”. Here the disclosed CT is an X-ray device).
With regard to Claim 3, Kim discloses the medical apparatus according to claim 1, wherein the model data set comprises a three-dimensional representation of the bone (Kim, Para 0039; “… generates a three-dimensional (3D) object model from the obtained CT image … the object may be construed as indicating a pelvis, a femur, a tibia, and the like of a human being …”).
With regard to Claim 4, Kim discloses the medical apparatus according to claim 1, wherein the model data set comprises at least one of: information relating to a removal of the implant; information relating to an implantation of the implant; information relating to a surgical procedure; and information relating to a surgical technique (Kim, Para 0040; “In step S102, the operator manufactures a 3D-shape patient-specific surgical guide instrument in which a sensor, for example, an electromagnetic sensor, is embedded, based on the 3D object model.” The disclosed 3D object model comprises one part of interest for which a 3D-shape PSI is manufactured, so relates to the implant and the surgical procedure).
With regard to Claim 5, Kim discloses the medical apparatus according to claim 1, wherein the implant is a hip implant or a knee implant (Kim discloses both a femoral PSI and an acetabular PSI, which are knee implant and hip implant respectively).
With regard to Claim 6, Kim discloses the medical apparatus according to claim 1, wherein the characteristic information characterizing the reference position information is or comprises a characteristic geometric structure of the reference element (PSI 23 or its occupied volume as shown in the cited Fig. 8 above).
With regard to Claim 7, Kim discloses the medical apparatus according to claim 6, wherein the characteristic geometric structure is or comprises a surface portion of the reference element (the surface determined by the plurality of second detectors 231, as shown in the cited Fig. 8 above).
With regard to Claim 8, Kim discloses the medical apparatus according to claim 6, wherein the data processing device is configured and programmed to determine an agreement of the reference position information with the position of the reference element by comparing the geometric structure (“coordinates on a 3D object model”) with a characteristic geometric comparison structure that is determinable based on position data that are determinable using the second marking device of the at least one medical marking device (Kim, Para 0069; “… the information processor may recognize, as coordinates of the PSI 23, the second detector 231 which may be provided as a plurality of second detectors in the PSI 23, and match the recognized coordinates to coordinates on a 3D object model (indicated by VF).”).
With regard to Claim 12, Kim discloses the medical apparatus according to claim 1, wherein the data processing device is configured and programmed to at least one of: a) determine the characteristic information based on an analysis of the model data set, b) determine the characteristic information based on an already known type of the reference element, and c) determine the characteristic information based on an individualized reference element (Kim, Para 0057; “the information processor may recognize, as coordinates of the PSI 23, the second detector 231 which may be provided as a plurality of second detectors in the PSI 23, and match the recognized coordinates to coordinates on a 3D object model (indicated by VF).” Kim manufactures an individualized part or PSI for a particular part based on 3D object model of a patient, and then match a plurality of corresponding points’ coordinates on the model and on the PSI; therefore it determines information based on both an analysis of the 3D object model and an individualized reference element).
With regard to Claim 13, Kim discloses the medical apparatus according to claim 1, further comprising at least one display device, wherein the model data set is, at least partially, displayable on the at least one display device (Kim, Para 0057; “The display 15 may display the insertion path of the surgical instrument 14 on the 3D object model. … verifying the 3D object model through the display 15 …”).
With regard to Claim 14, Kim discloses the medical apparatus according to claim 13, wherein the at least one display device is at least one of: stationary; and arranged on one of: the data processing device, which comprises a portable data processing device, and a head-mounted device (Kim, Fig. 3 shows a display 15 that is stationary).
With regard to Claim 16, Kim discloses the medical apparatus according to claim 13, wherein the at least one display device is configured to display instructions relating to at least one of the following: instructions relating to a removal of the implant, instructions relating to an implantation of the implant, instructions relating to a surgical procedure, and instructions relating to a surgical technique (Kim, Para 0057; “The display 15 may display the insertion path of the surgical instrument 14 on the 3D object model.” The disclosed insertion path of a surgical instrument relates to a surgical procedure).
With regard to Claim 17, Kim discloses the medical apparatus according to claim 1, wherein the at least one medical marking device is attachable to the bone in a direct invasive manner or in an indirect non-invasive manner (as shown in Fig. 3 and Fig. 8, the first detectors 121 and 221 are attached to the bones).
With regard to Claim 18, Kim discloses a medical method for registering a model data set (Kim, Fig. 1 shows a flowchart comprising such a method) comprising the steps of:
providing a model data set with a spatial representation of a bone (Kim, Para 0039; “… in step S101, an operator obtains a computed tomography (CT) image from an object and generates a three-dimensional (3D) object model from the obtained CT image … the object may be construed as indicating a pelvis, a femur, a tibia …”), wherein the model data set comprises a piece of characteristic information characterizing a piece of reference position information of a reference element arranged on the bone in a defined spatial position (Kim, Para 0040; “In step S102, the operator manufactures a 3D-shape patient-specific surgical guide instrument … based on the 3D object model.”; Para 0041; “In step S103, the operator dislocates the femur from the pelvis, and inserts the femoral PSI into the head of the femur.”. In these disclosures, by removing the femur and inserting the femoral PSI, the 3D object model contains position information of the femoral PSI);
providing a reference coordinate system on the bone (Kim, Para 0052; “… a positional relationship between a position of the surgical site A and a position of the surgical instrument 14 may be obtained as the first detector 121 and the third detector 141 detect the position of the surgical site A and the position of the surgical instrument 14, respectively. That is, relative positional information of the surgical site A and the surgical instrument 14 may be obtained.” According to this disclosure, other positions such as those of surgical instruments during surgery are determined relative to the position determined by the first detector 121, so information of the first detector 121 provides a reference coordinate system) based on position data of a first marking device arranged in a defined spatial position relative to the bone (Kim, Para 0050; “The first detector 121 may be attached to a surgical site of an object and detect a position attached to the surgical site. … the first detector 121 may be attached to an acetabular margin of the acetabulum A”);
determining a piece of characteristic information characterizing the position of the reference element in the reference coordinate system (Kim, Para 0051; “when the PSI 13 is inserted in the surgical site A, the second detector 131 may detect a position in which the PSI 13 is inserted … the PSI 13 may be temporarily used before the surgical operation is performed to register a position of the surgical site A at which the first detector 121 is arranged, and not be used during the operation”) based on position data obtained by a second marking device (Kim, Para 0051; “The second detector 131 may receive the electromagnetic wave generated from the electromagnetic wave generator 11, and detect a position of a PSI 13.”. Here the disclosed second detector 131 corresponds to the claimed second marking device. The other example is the second detector 231 in Fig. 8, as cited below);
providing an agreement of the position of the reference element in the reference coordinate system with the reference position information in the model data set (Kim, Para 0042; “In step S104, the operator performs registration between the femoral PSI and the 3D object model … Here, the registration refers to matching coordinates of an actual model and coordinates of a virtual model …”); and
registering, based on the agreement, the model data set in the reference coordinate system with regard to an overlap of the model data set and the bone (Kim, Para 0042; “… performs registration between the femoral PSI and the 3D object model … the registration refers to a processing method that geometrically aligns two or more images to overlap the images”. Examples are demonstrated in Fig. 3 for the pelvis, and in Fig. 8 for the femur).
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.
Claims 9 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Kim, in view of Hughes et al (US 20110257653 A1; hereafter Hughes).
With regard to Claim 9, Kim discloses the medical apparatus according to claim 1, but does not explicitly and clearly disclose comprising a surgical palpating tool,
wherein the second marking device of the at least one medical marking device is arrangeable on the surgical palpating tool, and
wherein a surface of the reference element is configured to be palpated with the surgical palpating tool for determining the position of the reference element in the reference coordinate system.
Hughes in the same field of endeavor discloses a surgical palpating tool (a surgical tool 300, as shown in Fig. 11),
wherein the second marking device of the at least one medical marking device is arrangeable on the surgical palpating tool (Hughes, Para 0060; “A surgical tool 300 comprising a body 320, tracking member 370 …”; the disclosed tracking member 370 corresponds to the claimed second tracking marking device), and
wherein a surface of the reference element (surface 202 of a patient-matched instrumentation block 200, as shown in the cited Fig. 11 below) is configured to be palpated with the surgical palpating tool for determining the position of the reference element in the reference coordinate system (Hughes, Para 0061; “… placing the cutting member 310 into each registration portion 210, 212, 214, 240, 242, 244 of the block 200 …”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Kim, as suggested by Hughes, in order to use a palpating tool with a tracking or marking device to determine position of an object in surgery. One of ordinary skill in the art would have been motivated to make the modification for the benefit of improved accuracy of surgical procedure by reliably registering real object of interest and its model (Hughes, Para 0006; “the accuracy of the surgical procedure may depend on how well the registered bone (which is based on 3D model or an image of the patient) matches the physical bone. That matching can be difficult to achieve. There is a need for a registration process that allows the surgeon to repeatedly and more efficiently register a patient's bone for surgery”).
Fig. 11 of Hughes
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With regard to Claim 11, Kim and Hughes disclose the medical apparatus according to claim 9, but do not explicitly and clearly disclose wherein the position of the reference element is determinable based on a plurality of characteristic points on the surface of the reference element, the plurality of characteristic points configured to be palpated by the surgical palpating tool.
Hughes further discloses wherein the position of the reference element is determinable based on a plurality of characteristic points on the surface of the reference element (surface 202 of a patient-matched instrumentation block 200), the plurality of characteristic points configured to be palpated by the surgical palpating tool (Hughes, Para 0059; “… the registration points 211, 213, 215, 241, 243, 245 of each registration portion may define one or more reference planes, such as an anterior coronal plane 240 or a distal transverse plane 260 … may comprise center registration points define other anatomical landmarks such as a mechanical axis 232 of the joint, an anatomic axis 234 of the joint, Whiteside's line 250, the epicondylar axis (252), or the like.”). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Kim and Hughes, as further suggested by Hughes, in order to use a plurality of characteristic points for determining position of an object. One of ordinary skill in the art would have been motivated to make the modification for the benefit of stable tracking of characteristic features that makes the following registration easy and accurate, and simplifying computation by processing positional information of only a number of points.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Kim and Hughes, in view of Thoranaghatte (US 20160000518 A1; hereafter Thoranaghatte).
With regard to Claim 10, Kim and Hughes disclose the medical apparatus according to claim 9, but do not explicitly and clearly disclose wherein the surgical palpating tool is movable along a predetermined or predeterminable path on the surface of the reference element.
Thoranaghatte in the same field of endeavor discloses wherein the surgical palpating tool is movable along a predetermined or predeterminable path on the surface of object to tracked (Thoranaghatte, Para 0121; “… register the edges of a tool as shown in FIG. 19, where index finger is kept at one end of the edge 956 and registration initiated by thumb adduction action. The index finger is slow slid over the edge 954, keeping the thumb adducted, to register the complete edge. When the index finger reaches the other end of the edge, thumb is abducted to terminate the registration process. FIG. 20 shows another example where a surface of bone, e.g. femur articular surface of knee joint 433, is registered in a similar method.” This disclosure shows that a surgeon’s index finger, used as a palpating tool, moves over the edge 954 of a surgical saw 955 (shown in Fig. 19), and move along a marked path on the articular surface of femur 433 (shown in Fig. 20)). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Kim and Hughes, as suggested by Thoranaghatte, in order to move a tracking tool along a predeterminable path on surface of object to be tracked. One of ordinary skill in the art would have been motivated to make the modification for the benefit of stable tracking of characteristic features that makes the following registration easy and accurate (Thoranaghatte, Para 0091; “four or more points are selected for stable tracking of the object orientation. The points should be chosen such that their surface topography around this point is distinct and good to detect in the 3D surface-mesh measured. E.g. the tool tip and special topographical markers formed by the tool can be used as object points.”).
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Kim, in view of Amanatullah (US 20190231433 A1; hereafter Amanatullah).
With regard to Claim 15, Kim discloses the medical apparatus according to claim 13, but does not explicitly and clearly disclose wherein the data processing device is configured and programmed to determine a position of the at least one display device in the reference coordinate system and to, in dependence thereon, display the model data set superimposed over the bone by augmented reality.
Amanatullah in the same field of endeavor discloses wherein the data processing device is configured and programmed to determine a position of the at least one display device in the reference coordinate system (Amanatullah, Para 0115; “… detect a position of an augmented reality headset - worn by a surgeon - proximal the surgical field …”) and to, in dependence thereon, display the model data set superimposed over the bone by augmented reality (Amanatullah, Para 0115; “… estimate a perspective of the surgeon viewing the surgical field based on the position of the augmented reality headset in the surgical field; generate an augmented reality frame that includes a projection of the virtual unresected hard tissue of interest aligned with the real hard tissue of interest of the patient from the perspective of the surgeon”). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Kim, as suggested by Amanatullah, in order to use augmented reality to display superimposed model and real object. One of ordinary skill in the art would have been motivated to make the modification for the benefit of improved accuracy or outcome for a surgical procedure by continuously comparing real-time surgical scene against 3D model or ideal surgical result.
Claims 19 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Kim, in view of Singh et al (US 20190090955 A1; hereafter Singh).
With regard to Claim 19, Kim discloses the method according to claim 18, but does not explicitly and clearly disclose a data processing program with program code for use in surgery supported by a data processing device, wherein the data processing program is configured to prompt the data processing device to perform a method when the data processing program is running on the data processing device or is loaded onto the data processing device.
Singh in the same field of endeavor discloses a data processing program with program code for use in surgery supported by a data processing device, wherein the data processing program is configured to prompt the data processing device to perform a method when the data processing program is running on the data processing device or is loaded onto the data processing device (Singh, Para 0095; “as illustrated in FIG. 3, processing and display unit 350 may include one or more hardware and/or software components configured to execute software programs, such as algorithms for tracking the pose of the anatomy and/or surgical instruments.”). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Kim, as suggested by Singh, in order to implement the method as a program executable by a processing device or unit. One of ordinary skill in the art would have been motivated to make the modification for the benefit of efficiently executing a method with computer device.
With regard to Claim 20, Kim and Singh disclose the data processing program according to claim 19, but as discussed above do not explicitly and clearly disclose a program storage medium.
Singh further discloses a program storage medium (Singh, Para 0098; “Storage 354 may include any type of mass storage device configured to store information that CPU/GPU 351 may need to perform processes consistent with the disclosed embodiments.”). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Kim and Singh, as further suggested by Singh, in order to use storage medium to store the data processing program. One of ordinary skill in the art would have been motivated to make the modification for the benefit of making a method being easily available to use on a different computer or site.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LEI ZHANG whose telephone number is (571)272-7172. The examiner can normally be reached Monday-Friday 8am-5pm E.T..
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/L.Z./Examiner, Art Unit 3798
/PASCAL M BUI PHO/Supervisory Patent Examiner, Art Unit 3798
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