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 2 objected to because of the following informalities: the limitation reading “fixed relative to the a body of the patient” is grammatically incorrect. Appropriate correction is required.
Claim Rejections - 35 USC § 101
Claims 1-7 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The claim recites selecting, calculating, acquiring, and multiplying steps. The limitations of selecting, calculating, acquiring, and multiplying as drafted represent a process that, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components. That is, other than reciting a spatial observation device nothing in the claim element precludes the step from practically being performed in the mind. For example, but for the spatial observation device language, acquiring in the context of this claim encompasses the user manually observing a feature. Similarly, the limitations of selecting, calculating, and multiplying, as drafted, is a process that, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components. For example, selecting, calculating, and multiplying in the context of this claim encompasses the user performing calculations by hand. If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components, then it falls within the “Mental Processes” grouping of abstract ideas. Accordingly, the claim recites an abstract idea. This judicial exception is not integrated into a practical application. In particular, the claim only recites one additional element – using a spatial observation device to perform the acquiring steps. The component is recited at a high-level of generality (i.e., as a generic processor performing a generic computer function of ranking information based on a determined amount of use) such that it amounts no more than mere instructions to apply the exception using a generic computer component. Accordingly, this additional element does not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea. The claim is directed to an abstract idea. The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application amounts to no more than mere instructions to apply the exception using a generic computer component. Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept. The claim is not patent eligible.
Dependent claims 2-7 similarly do not introduce additional elements that are sufficient to amount to significantly more than the judicial exception, aside from generic processing components such as navigation hardware (claim 3), a generator (claim 4), and a camera (claim 4), the integration of the abstract idea into a practical application amounts to no more than mere instructions to apply an exception using a generic computer component and cannot provide an inventive concept. The claims are not patent eligible.
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.
Claim(s) 1-4 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Barsoum (US 20140200439 A1) in view of Zheng (CN 107028659 A).
Regarding claim 1, Barsoum teaches a method for accurately positioning a navigation target point ([0004] A patient-specific instrument is placed into a predetermined setting position with respect to the patient tissue)
selecting a navigation reference with a fixed position ([0004] A navigation aid is associated in a predetermined origin position with respect to the patient tissue via a physical relationship between the navigation aid and the patient-specific instrument)
acquiring positions of the navigation reference and the navigation target point in a navigation coordinate system respectively, and calculating a position of the navigation target point relative to the navigation reference, so as to further obtain a position of the navigation target point in a coordinate system of the navigation reference ([0004] A navigation aid is associated in a predetermined origin position with respect to the patient tissue via a physical relationship between the navigation aid and the patient-specific instrument. The navigation aid is zeroed while in the predetermined origin position to record the location and orientation of the navigation aid relative to the patient tissue)
acquiring, by a spatial observation device, a real-time position and shape feature information of the navigation reference and a real-time position of the navigation target point, wherein both the navigation target point and the navigation reference are respectively provided with a positioning apparatus ([0033] the user could choose/predetermine her own predetermined model location points in real-time during the registration procedure by touching the wand 520 to the model 514; because the surgical navigation system "knows" the relationship of the patient tissue to the coordinate indicator 516 and the position of the coordinate indicator 516 within the room, the surgical navigation system will then be able to store those user-chosen predetermined model location points as "landmarks" on the virtual model)
Barsoum fails to teach acquiring, by the spatial observation device, rotation quaternions and spatial position coordinates of the navigation reference in real time in the navigation coordinate system as (Qo, Qx, Qy, Qz, TxO, TyO, TzO) and position coordinates of the navigation target point as (Txl, Tyl, Tz1); calculating a corresponding rotation matrix M based on the quaternions (Qo, Qx, Qy, Qz); multiplying a spatial position coordinate (TxO, TyO, TzO) of the navigation reference and a spatial position coordinate (Txl, Tyl, Tzl) of the navigation target point in the navigation coordinate system by the rotation matrix M, respectively, to obtain the spatial position coordinate of the navigation reference (TxO1, Ty01, TzO1) and the spatial position coordinate of the navigation target point (Txll, Tyl1, Tzll) in a temporary coordinate system, wherein a coordinate origin of the temporary coordinate system coincides with a origin of the navigation coordinate system, and directions of coordinate axes of the temporary coordinate system are consistent with shape features of the navigation reference ; and calculating position coordinates of the navigation target point in a coordinate system of the navigation reference as (Txl1-Tx01, Tyl1-Ty01, Tzl1-Tz01) based on spatial position coordinate of the navigation reference (Tx01, Ty01, Tz01) and spatial position coordinate of the navigation target point (Txl 1, Tyl 1, Tzl1) in the temporary coordinate system.
However, Zheng teaches acquiring, by the spatial observation device, rotation quaternions and spatial position coordinates of the navigation reference in real time in the navigation coordinate system as (Qo, Qx, Qy, Qz, TxO, TyO, TzO) and position coordinates of the navigation target point as (Txl, Tyl, Tz1) ([0050] the tracking system 1 may adopt an optical tracking system or an electromagnetic tracking system. The tracking system 1 detects the calibration tracer 2 and the surgical instrument tracer 4 through its own position sensor, completes the position tracking measurement of the bed coordinate system and the surgical instrument coordinate system, obtains the position of the origin of the bed coordinate system and the surgical instrument coordinate system in the tracking system coordinate system, and the rotation angles of the three coordinate axes of the bed coordinate system and the surgical instrument coordinate system relative to the tracking system coordinate system)
calculating a corresponding rotation matrix M based on the quaternions (Qo, Qx, Qy, Qz); multiplying a spatial position coordinate (TxO, TyO, TzO) of the navigation reference and a spatial position coordinate (Txl, Tyl, Tzl) of the navigation target point in the navigation coordinate system by the rotation matrix M, respectively, to obtain the spatial position coordinate of the navigation reference (TxO1, Ty01, TzO1) and the spatial position coordinate of the navigation target point (Txll, Tyl1, Tzll) in a temporary coordinate system, wherein a coordinate origin of the temporary coordinate system coincides with a origin of the navigation coordinate system, and directions of coordinate axes of the temporary coordinate system are consistent with shape features of the navigation reference ; and calculating position coordinates of the navigation target point in a coordinate system of the navigation reference as (Txl1-Tx01, Tyl1-Ty01, Tzl1-Tz01) based on spatial position coordinate of the navigation reference (Tx01, Ty01, Tz01) and spatial position coordinate of the navigation target point (Txl 1, Tyl 1, Tzl1) in the temporary coordinate system ([claim 5] calibration of each coordinate system using the calibration tracer is performed by:
(a) utilizing the CT equipment to scan the coordinates of each point of the navigation identification in the coordinate system of the CT equipmentByFitting the coordinates of each point in the characteristic point set I in the coordinate system of the CT equipment
(b) Measuring the coordinates of each point in the feature point set II in the tracking system coordinate system by using the tracking system, and obtaining the coordinates of each point in the feature point set I in the tracking system coordinate system because the relationship from the feature point set I to the feature point set II is knownFurther obtaining the pose of the CT equipment coordinate system in the tracking system coordinate system
(c) SelectingOne of the characteristic points is represented by an identification coordinate system origin OmarkerIs connected toGenerating L column vectors at each point, and selecting two linearly independent vectorsWherein,as a direction vector identifying the x-axis of the coordinate system,as the direction vector of the Y axis of the identification coordinate system, finally determining the direction vector of the Z axisGenerating a space rectangular coordinate system according to the right-handed screw rule, normalizing the three coordinate axes to obtain a rotation matrix
(d) The translation vector is the coordinate of the origin of the identification coordinate system in the tracking system:
obtaining a transformation relation
(e) Due to the relationship between the feature point set I and the feature point set IIAs is known, the transformation relationship from the CT device coordinate system to the patient bed coordinate system is obtained)
Barsoum and Zheng are considered analogous because both disclose medical tracking systems. Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the pending application to use a matrix of rotation information to calibrate the coordinates of the positioning system so that patients suffer less trauma and recover faster, only local anesthesia is required, with little impact on normal organs (Zheng [0004]).
Regarding claim 2, Barsoum teaches the navigation reference is fixed at a place where a body surface of a patient does not move or other places fixed relative to the a body of the patient ([0035] both the model 514 and the actual patient tissue (e.g., acetabulum 100) will be relatively rigidly affixed in their respective absolute positions within the room such that the global location system considers them "fixed" in position within the surgical navigation space)
Regarding claim 3, Barsoum teaches a position of the origin the navigation coordinate system and the directions of the coordinate axes of the navigation coordinate system are determined by navigation hardware ([0036] the predetermined model location points, have been registered with the global location system. In such event, the PSI-less acetabulum 100 or other patient tissue could include at least one predetermined tissue location point. Each predetermined tissue location point bears a substantial correspondence to a selected one of the predetermined model location points which have already been established/oriented with use of the model 514 (whether as preselected landmark areas or real-time user-selected portions of the model))
Regarding claim 4, Barsoum teaches the navigation hardware is an electromagnetic generator in electromagnetic navigation technology or an optical camera in optical navigation technology ([0019] The navigation aid 204 includes and/or is operatively connected to (wired and/or wirelessly) sufficient sensors (e.g., accelerometers, magnetometers, high-resolution integrators, and/or GPS sensors), processors, user interfaces, and other components as desired to provide the functions described herein)
Regarding claim 7, Barsoum teaches a shape of the navigation reference is a cross ([0041] Though certain components described herein are shown as having specific geometric shapes, all structures of the present invention may have any suitable shapes, sizes, configurations, relative relationships, cross-sectional areas, or any other physical characteristics as desirable for a particular application of the present invention).
Claim(s) 5-6 are rejected under 35 U.S.C. 103 as being unpatentable over Barsoum in view of Zheng as applied to claim 1 above, and further in view of Yin (US 20210196402 A1).
Regarding claim 5, Barsoum fails to teach thoracoabdominal puncture surgery.
However, Yin teaches thoracoabdominal puncture surgery ([0004] medical operation (e.g., a puncture surgery, a minimally invasive surgery); [0096] the subject may include a specific portion of a body, such as a head, a thorax, an abdomen, or the like, or any combination thereof)
Barsoum as modified and Yin are considered analogous because both disclose medical positioning systems. Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the pending application to use the described system in a puncture surgery involving the abdomen or thorax in order to facilitate image-guided surgery (Yin [0004])
Regarding claim 6, Barsoum fails to teach the navigation target point is a needle.
However, Yin teaches a needle ([0020] The at least one operating element may include at least one of a scalpel or a puncture needle)
Barsoum as modified and Yin are considered analogous because both disclose medical positioning systems. Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the pending application to use the described a needle in the aforementioned surgical procedure in order to facilitate image-guided surgery (Yin [0004]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GABRIEL VICTOR POPESCU whose telephone number is (571)272-7065. The examiner can normally be reached M-F 8AM-5PM.
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/GABRIEL VICTOR POPESCU/ Examiner, Art Unit 3798
/PASCAL M BUI PHO/ Supervisory Patent Examiner, Art Unit 3798