DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
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(s) 1-10 is/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.
Regarding Claim 10
Claim 10 recites, “the implanted position” in the last line. The claim limitation is confusing as it is unclear whether the claimed implanted position is with respect to the first implant or the second implant. Clarification is required.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of pre-AIA 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 –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claim(s) 1-11, 13 & 15-20 is/are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Marquart et al. (U.S. Patent Application 2006/0173293 A1).
Claim 1: Marquart teaches –
A method for computer-assisted stereotactic surgery [computer-assisted surgery (CAS) system] (Para 0022 and Figure 1), comprising:
implanting a first implant [an IM nail implantation] (Para 0031) coupled to a reference body [trackable elements] (Para 0023) in a region of interest of patient's anatomy [implantation of an IM nail into the femur] (Para 0030),
the reference body [trackable elements] (Para 0023) having at least four radiopaque fiducial markers arranged in a three-dimensional pattern [Markers will have a known, geometrical arrangement with respect to, typically, an end point and/or axis of the instrument] (Para 004 and See Figure 27, which displays a reference body having four trackable markers arranged in a three-dimensional pattern) detectable by a fluoroscopic imaging system [multiple fluoroscopic images are simultaneously displayed of display device 12, the representation of the tracked instrument or tool is coordinated between the different images] (Para 0024);
acquiring a first set of two-dimensional fluoroscopic images [two-dimensional fluoroscopic images] (Para 0003) of the region of interest including the first implant and reference body at different angles using the fluoroscopic imaging system [capable of using two-dimensional image data sets, multiple images are usually taken from different angles and registered to each other so that a representation of the tool or other object (which can be real or virtual) can be, in effect, projected into each image. As the position of the object changes in three dimensional space, its projection into each image is simultaneously updated] (Para 0007);
processing the first set of two-dimensional fluoroscopic images to produce a three- dimensional reconstruction of the region of interest [capable of using two-dimensional image data sets, multiple images are usually taken… so that a representation of the tool or other object… can be, in effect, projected into each image. As the position of the object changes in three dimensional space, its projection into each image is simultaneously updated] (Para 0007);
determining a position [location of an object's position] (Para 0004) of the first implant using the fiducial markers from the three-dimensional reconstruction [location of an object's position may be based on intrinsic features or landmarks that, in effect, function as recognizable markers. Markers will have a known, geometrical arrangement with respect to, typically, an end point and/or axis of the instrument] (Para 0004) [orientation of the axis and location of endpoint within a frame of reference deduced from the positions of the markers] (Para 0004);
identifying a current step in a surgical workflow based on the position of the first implant and the reference body without user input [the program may automatically detect the stage of the procedure by recognizing/identifying the instrument picked up by a surgeon and move immediately to the part of the program in which that tool is used] (Para 0026);
determining a next step to be performed subsequent to the current step [At a particular stage or part of a program, a surgeon may be automatically prompted to perform certain tasks] (Para 0025) [the process automatically recognizing when the surgeon has either finished a stage] (Para 0032), the next step including generating a virtual representation of a second implant associated with the first implant [the program to determine and display appropriate placement and alignment of instrumentation or implants or provide feedback to the surgeon] (Para 0025) [A representation 1608 of the proximal end of the nail is also preferably superimposed on the two images, along with representations 1610 of screws] (Para 0042);
displaying the virtual representation of the second implant [screws] (Para 0042) superimposed on the three-dimensional reconstruction of the region of interest [A representation 1608 of the proximal end of the nail is also preferably superimposed on the two images, along with representations 1610 of screws that will be inserted through the proximal end of the femur and nail once the nail is fully inserted] (Para 0042);
implanting the second implant [guide a surgeon in inserting the locking screw, a representation 2706 of the instrument being used for the insertion is superimposed on the images] (Para 0054);
acquiring a second set of two-dimensional fluoroscopic images to determine an implanted position of the second implant [representing the IM nail on images taken of the patient's leg and providing feedback to the surgeon on the position of the nail during the nail insertion] (Para 0033), and
comparing the implanted position of the second implant to a desired position of the second implant and providing feedback to a user regarding the implanted position [The navigation or execution stage tracks the surgeon's instruments and trackable markers implanted in or attached to the patient's femur and provides alignment information and feedback on version and length] (Para 0031).
Examiner’s Note: While the prior art does use the same terminology as the claim limitations, it is understood to be synonymous by continuously taking images during surgery and providing feedback to the surgeon on how well the correct position aligns with the planned/desired position.
Claim 2/1: Marquart teaches wherein the first implant is a locking nail [an entry point in the femur prior to insertion of the nail, the tool used for nail insertion, the instrument used for drilling holes to insert screws for locking the distal end of the nail] (Para 0035).
Claim 3/2/1: Marquart teaches wherein the second implant is a screw [an entry point in the femur prior to insertion of the nail, the tool used for nail insertion, the instrument used for drilling holes to insert screws for locking the distal end of the nail] (Para 0035).
Claim 4/1: Marquart teaches wherein the first set of two-dimensional fluoroscopic images are taken at angles approximately 90 degrees apart [acquire an anterior/posterior (A/P) and a medial/lateral (M/L) image of each of the proximal and distal ends of the femur] (Para 0037).
Examiner’s Note: The A/P and M/L images are approximately 90 degrees apart.
Claim 5/1: Marquart teaches further comprising obtaining pre-operative images of the region of interest [registering a patient and preoperative and/or intraoperative diagnostic image data sets to the coordinate system of the tracking system] (Para 0024), determining a desired position of the first implant and the second implant based on the pre-operative images [registering a patient and preoperative and/or intraoperative diagnostic image data sets to the coordinate system of the tracking system] (Para 0024).
Claim 6/1: Marquart teaches wherein the step of identifying the current step in the surgical workflow includes detecting a position of the reference body relative to the first implant [the program may automatically detect the stage of the procedure by recognizing/identifying the instrument picked up by a surgeon] (Para 0026).
Examiner’s Note: It is understood that the instrument includes the first implant and the implant has a reference body attached.
Claim 7/1: Marquart teaches further comprising analyzing the three-dimensional reconstruction to determine a geometry of a fracture and recommending any of a type, size and shape of the second implant based on the determined geometry [the diameter of the nail is estimated using at step 618, the midshaft (isthmus) of the well or injured leg] (Para 0043) [If the fit is not correct, the surgeon can change the end points and/or select a different nail] (Para 0042).
Claim 8/7/1: Marquart teaches further comprising acquiring a third set of two-dimensional fluoroscopic images intra-operatively [intraoperative diagnostic image data sets] (Para 0024), updating [constantly updated in real time] (Para 0024) the three-dimensional reconstruction based on the third set of two-dimensional fluoroscopic images [As the position of the object changes in three dimensional space, its projection into each image is simultaneously updated] (Para 0007), and modifying the recommendation for the second implant based on the third set of two-dimensional fluoroscopic images [assist the surgeon with selecting a nail of appropriate length and screw dimensions using the well leg] (Para 0042) [process automatically determines the distance between the end points and then it selects and displays on the images a representation of the closest standard length nail] (Para 0042).
Claim 9/1: Marquart teaches wherein the virtual representation of the second implant includes a proposed trajectory [determine trajectory of the screws] (Para 0053) and depth for implantation of the second implant [indicating visually a trajectory for a drill or saw on the screen] (Para 0025).
Claim 10/1: Marquart teaches further comprising calculating a required length for the second implant based on the three-dimensional reconstruction and the position of the first implant, and displaying the calculated length to the user before implanting the second implant [The program then provides an estimated nail length and displays the two closest standard lengths for the type of nail being used on line 1710. The surgeon selects the desired length and the program moves the nail representation to the correct length for the surgeon to confirm that selected length] (Para 0042 and Figure 5).
Claim 11: Marquart teaches –
A system for computer-assisted stereotactic surgery [computer-assisted surgery (CAS) system] (Para 0022 and Figure 1), comprising:
a memory [working memory] (Para 0022) storing pre-operative images of a region of interest of a patient's anatomy [graphical images are constructed from one or more stored image data sets 26 acquired from diagnostic imaging device 28] (Para 0024) and data regarding desired implant positions [the surgeon indicates to the process…desired position of the nail head and the screws that lock the nail head] (Para 0047);
an imaging apparatus [Imaging device may be a fluoroscope, such as a C-arm fluoroscope] (Para 0024) for acquiring intra-operative fluoroscopic images [preoperative and/or intraoperative diagnostic image data sets] (Para 0024), and
a processor [processor-based system] (Para 0024) configured to:
process the pre-operative images to determine an optimal position for a first implant and an associated second implant [display the positions of surgical tools with respect to preoperative (prior to surgery)] (Para 0003);
receive intra-operatively fluoroscopic images of the region of interest with the first implant coupled to a reference body [trackable elements] (Para 0023) having at least four radiopaque fiducial markers arranged in a three-dimensional pattern [Markers will have a known, geometrical arrangement with respect to, typically, an end point and/or axis of the instrument] (Para 004 and See Figure 27, which displays a reference body having four trackable markers arranged in a three-dimensional pattern) detectable by a fluoroscopic imaging system [multiple fluoroscopic images are simultaneously displayed of display device 12, the representation of the tracked instrument or tool is coordinated between the different images] (Para 0024);
process the intra-operative fluoroscopic images to produce three-dimensional information [capable of using two-dimensional image data sets, multiple images are usually taken… so that a representation of the tool or other object… can be, in effect, projected into each image. As the position of the object changes in three dimensional space, its projection into each image is simultaneously updated] (Para 0007) and
determine a current position [location of an object's position] (Para 0004) of the first implant using the fiducial markers [location of an object's position may be based on intrinsic features or landmarks that, in effect, function as recognizable markers. Markers will have a known, geometrical arrangement with respect to, typically, an end point and/or axis of the instrument] (Para 0004) [orientation of the axis and location of endpoint within a frame of reference deduced from the positions of the markers] (Para 0004);
compare the current position of the first implant with a predetermined position determined from the pre-operative images [The navigation or execution stage tracks the surgeon's instruments and trackable markers implanted in or attached to the patient's femur and provides alignment information and feedback] (Para 0031),
Examiner’s Note: While the prior art does use the same terminology as the claim limitations, it is understood to be synonymous by continuously taking images during surgery and providing feedback to the surgeon on how well the correct position aligns with the planned/desired position.
calculate translation and rotation adjustments required to position the first implant from the current position to a predetermined position [The surgeon shifts and rotates the representation of the nail so that it fits properly in the canal and the locking screws extend up the neck of the femur shown in the images. The representations of the screws are fixed to the representation of the nail, and rotate and shift with it. When the surgeon is satisfied with the placement of the nail and locking screws, this information is stored] (Para 0047);
provide visual or auditory instructions to a user for repositioning the first implant to achieve the predetermined position [communicate information in ways, including using audibly (e.g. using voice synthesis) and tactilely, such as by using a haptic interface of device. For example, in addition to indicating visually a trajectory for a drill or saw on the screen, a CAS system may feedback to a surgeon information whether he is nearing some object or is on course with a audible sound or by application of a force or other tactile sensation to the surgeon's hand] (Para 0025);
generate a virtual representation of a second implant based on the repositioned first implant [A representation 1608 of the proximal end of the nail is also preferably superimposed on the two images, along with representations 1610 of screws that will be inserted through the proximal end of the femur and nail once the nail is fully inserted] (Para 0042), and
display the virtual representation of the second implant [screws] (Para 0042) superimposed on the region of interest to guide implantation of the second implant [A representation 1608 of the proximal end of the nail is also preferably superimposed on the two images, along with representations 1610 of screws that will be inserted through the proximal end of the femur and nail once the nail is fully inserted] (Para 0042).
Claim 13/11: Marquart teaches wherein the imaging apparatus is a fluoroscope configured to acquire images at angles approximately 90 degrees apart [acquire an anterior/posterior (A/P) and a medial/lateral (M/L) image of each of the proximal and distal ends of the femur] (Para 0037).
Examiner’s Note: The A/P and M/L images are approximately 90 degrees apart.
Claim 15/11: Marquart teaches wherein the processor is further configured to detect movement of the region of interest during surgery using the fiducial markers, and adjust the three-dimensional information and the virtual representation of the second implant in response to the detected movement [As the position of the object changes in three dimensional space, its projection into each image is simultaneously updated] (Para 0007).
Claim 16/11: Marquart teaches wherein the processor is further configured to calculate a required length for the second implant based on the three-dimensional information and the position of the first implant, and display the calculated length to the user before implantation of the second implant [The program then provides an estimated nail length and displays the two closest standard lengths for the type of nail being used on line 1710. The surgeon selects the desired length and the program moves the nail representation to the correct length for the surgeon to confirm that selected length] (Para 0042 and Figure 5).
Claim 17/11: Marquart teaches wherein the virtual representation of the second implant includes a proposed trajectory [determine trajectory of the screws] (Para 0053) and depth for implantation displayed as a projection on the region of interest [indicating visually a trajectory for a drill or saw on the screen] (Para 0025).
Claim 18/11: Marquart teaches wherein the processor is further configured to analyze the pre-operative images to determine a geometry of a fracture in the region of interest, and recommend any of a type, size, and shape of the second implant based on the determined geometry [the diameter of the nail is estimated using at step 618, the midshaft (isthmus) of the well or injured leg] (Para 0043) [If the fit is not correct, the surgeon can change the end points and/or select a different nail] (Para 0042).
Claim 19/11: Marquart teaches wherein the processor is further configured to receive intra-operative fluoroscopic images [intraoperative diagnostic image data sets] (Para 0024) after repositioning the first implant [As the position of the object changes in three dimensional space, its projection into each image is simultaneously updated] (Para 0007), update the
three-dimensional information and recalculate the adjustments if necessary [its position is automatically updated with respect to the second image] (Para 0040), and provide updated instructions to the user for further repositioning [The surgeon will use the nail and screw representations to ensure that the screws are correctly aligned with the femoral neck] (Para 0052) [To guide a surgeon in inserting the locking screw, a representation 2706 of the instrument being used for the insertion is superimposed on the images. A representation 2708 of the locking screw on the end of the instrument is also superimposed] (Para 0054).
Claim 20/11: Marquart teaches wherein the reference body is attachable to an aiming device [trackable user input device] (Para 0028), and the fiducial markers are arranged to identify the first implant [a representation of the tool or other object (which can be real or virtual) can be, in effect, projected into each image. As the position of the object changes in three dimensional space, its projection into each image is simultaneously updated] (Para 0007 & 0023).
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) 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(s) 12 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Marquart et al. (U.S. Patent Application 2006/0173293 A1) and further in view of Mire et al. (U.S. Patent Application 2004/0171924 A1).
Claim 12/11: Marquart teaches the second implant is a screw [screws] (Para 0042). Marquart failS to recite the plate. However, Rubbert teaches wherein the first implant is an intracapsular plate [fixation plates,…for example,…long bones…osteosynthesis plates] (Para 0424) as the implant needs to be appropriate to the purpose of the patient bone treatment in order to fit into the desired treatment location (Para 0424).
The Examiner is applying KSR from MPEP § 2143(I)(A); Simple Substitution of One Known Element for Another To Obtain Predictable Results for the combination of Marquart/Mire and Rubbert as described below:
(1) a finding that the prior art contained a device (method, product, etc.) which differed from the claimed device by the substitution of some components (step, element, etc.) with other components;
The Examiner finds that Marquart contained a device (locking nail) which differed from the claimed device (intracapsular plate of the Applicant) by substitution of some components (locking nail of Marquart) with other components (intracapsular plate of Rubbert).
(2) a finding that the substituted components and their functions were known in the art;
The Examiner finds that the substituted components (intracapsular plate of Rubbert) and their functions were known in the art. The intracapsular plate of Rubbert and its function of stabilizing long bones is known within the art as demonstrated by the disclosure of Rubbert (Para 0424).
(3) a finding that one of ordinary skill in the art could have substituted one known element for another, and the results of the substitution would have been predictable; and
The Examiner finds that one of ordinary skill in the art could have substituted one known element (locking nail of Marquart) for another (intracapsular plate of Rubbert), and the results of the substitution would have been predictable. The substitution would have been predictable in that it would have function of stabilizing long bones is known within the art as demonstrated by the disclosure of Rubbert (Para 0424).
(4) whatever additional findings based on the Graham factual inquiries may be necessary, in view of the facts of the case under consideration, to explain a conclusion of obviousness
It would have been obvious to one of ordinary skill in the art at the time of the invention to substitute the locking nail of Marquart with the intracapsular plate of Rubbert in order to be useful stabilizing long bones (Para 0424). Due to the differences in bone injuries, different implants may be required. The Examiner contends that substituting the appropriate implant depending on the patient injury would have been obvious in order to stabilize long bones and treat the patient’s injury properly (Para 0424).
Claim(s) 14 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Marquart et al. (U.S. Patent Application 2006/0173293 A1) and further in view of Ruppert et al. (JP 2004504077 A; enclosed herein and English Translation referenced).
Claim 14/11: Marquart fails to specifically teach wherein the reference body is contoured to match a surface of the first implant. Mire teaches –
wherein the reference body is contoured to match a surface of the first implant to restrict relative movement between the reference body and the first implant [tracking sensors may be affixed to any of the appropriate portions (FIG. 24B)] (Para 0192 and Figure 24B) in order to allow for determining the location of the obtained implant relative to the selected portion of the anatomy for the benefit of precise placement of the implant (Para 0198) in order to improve surgical outcomes
Examiner’s Note: Figure 24B demonstrates that the tracking sensor (Element 58) is contoured to the implant as the tracking sensor is ring shaped to the contour of the implant tube (Element 479b).
It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the reference body of Marquart to be contoured based on the teachings of Mire in order to allow for determining the location of the obtained implant relative to the selected portion of the anatomy for the benefit of precise placement of the implant (Para 0198) in order to improve surgical outcomes.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Sarin et al. (U.S. Patent Application 2004/0097952 A1) – Sarin teaches a method and system for intra-operative navigation of a joint replacement operation, without recourse to pre-operative imagery of pre-operative computerized simulations. Trackable markers and a locating system are employed to track first and second bones. A computer receives positional information regarding the trackable markers and calculates (predicts) at least one suggested combination of components of a modular implant system to produce a desired post-operative skeletal relationship.
Zhao et al. (U.S. Patent Application 2010/0168562 A1) – Zhao teaches to systems, methods, and tools for tool tracking using image-derived data from one or more tool-located reference features. A method includes: capturing a first image of a tool that includes multiple features that define a first marker, where at least one of the features of the first marker includes an identification feature; determining a position for the first marker by processing the first image; determining an identification for the first marker by using the at least one identification feature by processing the first image; and determining a tool state for the tool by using the position and the identification of the first marker.
Tremblay et al. (U.S. Patent 7,840,253 B2) – Tremblay teaches a surgical navigation system for tracking a procedure relative to a patient is disclosed. The system can track a portion of the patient, an instrument, both, and both or either relative to image data, a coordinate system, an atlas, a morphed atlas, or combinations thereof. The system can include a minimally or non-invasive dynamic reference frame and/or fiducial marker, sensor tipped instruments, and isolator circuits.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HELENE C BOR whose telephone number is (571)272-2947. The examiner can normally be reached Mon - Fri 10:30 - 6:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Christopher Koharski can be reached at (571) 272-7230. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Helene Bor/Examiner, Art Unit 3797
/CHRISTOPHER KOHARSKI/Supervisory Patent Examiner, Art Unit 3797
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