ill2DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 11/20/2025 has been entered.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim(s) 1-20 is/are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding Claim 1
Claim 1 states, “the reference body having a contoured surface that is shaped to match a surface contour of the first implant to restrict movement between the reference body and the first implant to predetermined degrees of freedom”. The Specification states in Para 0098, “The reference plate (ICP) is contoured to match the surface contour of the bone to restrict the degrees of freedom for adjustments”. The Specification as originally filed supports the ICP contouring to the bone but NOT contouring to the first implant. Additionally, Claim 1 states, “such that the first implant and the reference body move as a single rigid body during positioning of the first implant and imaging”. The Examiner was able to find the term rigid within the Specification as originally filed.
Regarding Claim 14
Claim 14 states, “wherein the coupling the first implant and the reference body including physically attaching the reference body to the first implant before positioning the first implant”. The Examiner was not able to find support for the amendment within the Specification as filed. The Examiner searched for the terms, couple, coupling, coupled and the term, before. No support for the amendment was found. Additionally, Claim 14 states, “the reference body defining a contoured interface corresponding with a surface of the first implant.” The Specification states in Para 0098, “The reference plate (ICP) is contoured to match the surface contour of the bone to restrict the degrees of freedom for adjustments”. The Specification as originally filed supports the ICP contouring to the bone but NOT contouring to the first implant.
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) 1-14 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 1
Claim 1 states on Line 3, “the reference body having at least four radiopaque fiducial markers” and on Line 9-10, “at least four radiopaque spherical fiducial markers”. It is unclear if the claim is referring to the elements cites as the same element or different elements. For the purposes of examination, the Examiner is assuming the elements are the same. Clarification is required.
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) 1-2, 4, 6-8 & 10-13 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); Barrera (U.S. Patent Application 2005/0145257 A1; Para 0017 of Barrera incorporates by reference: Malackowshi et al. (U.S. Patent Application 2003/0093103 A1)) and Goldbach (U.S. Patent Application 2008/0185430 A1).
Claim 1: Marquart teaches –
A system for stereotactic surgery [computer-assisted surgery (CAS) system] (Para 0022 and Figure 1), comprising:
a first implant [an IM nail implantation] (Para 0031) implantable in a portion of a patient [implantation of an IM nail into the femur] (Para 0030) and a reference body [trackable elements] (Para 0023),
the reference body having at least four (See Figure 27, which displays a reference body having four trackable markers) radiopaque fiducial markers [radio-opaque fiducials having a known geometric relationship] (Para 0007) [geometrical relationships between trackable markers] (Para 0023) arranged in a three-dimensional pattern, the reference body in a known spatial relationship with the first implant [With information from the tracking system on the location of the trackable markers, CAS system 10 is programmed to be able to determine the three-dimensional coordinates of an endpoint or tip of a tool and, optionally, its primary axis using predefined or known (e.g. from calibration) geometrical relationships between trackable markers on the tool and the end point and/or axis of the tool] (Para 0023) and contacting the first implant [one or more trackable elements disposed on, incorporated into, or inherently a part of surgical instruments or tools] (Para 0016;
a fluoroscopic imaging system [C-arm fluoroscope] (Para 0024) configured to detect the at least four radiopaque spherical fiducial markers (See Figure 27, which displays a reference body having four trackable markers and spherical) [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);
a processor [processor] (Figure 1, Element 17) in communication with (See Figure 1 which discloses the elements being in communication) the fluoroscopic imaging system [diagnostic imaging device] (Figure 1, Element 28), the processor configured to:
acquire first and second two-dimensional fluoroscopic images [two-dimensional fluoroscopic images] (Para 0003) of the reference body together with the portion of the patient [multiple images are usually taken from different angles and registered to each other so that a representation of the tool or other object] (Para 0007) [With information from the tracking system on the location of the trackable markers, CAS system 10 is programmed to be able to determine the three-dimensional coordinates of an endpoint or tip of a tool] (Para 0023) [registering a patient and preoperative and/or intraoperative diagnostic image data sets to the coordinate system of the tracking system] (Para 0024);
register the first and second images using the reference body [registering a patient and preoperative and/or intraoperative diagnostic image data sets to the coordinate system of the tracking system] (Para 0024);
process the first and second images to produce a three dimensional reconstruction of the portion of the patient using a location of the fiducial markers [position of the fiducials in three-dimensional space] (Para 0007) [Image-based surgical navigation systems display the positions of surgical tools with respect to preoperative (prior to surgery) or intraoperative (during surgery) image data sets. Two and three dimensional image data sets are used] (Para 0003) in the reference body [the CAS system overlaying a representation of the tracked instrument on one or more graphical images of the patient's internal anatomy on display device] (Para 0024);
determine a position of the first implant in the portion of the patient from the first and second images [providing feedback to the surgeon on the position of the nail during the nail insertion] (Para 0033);
generate a virtual representation of a second implant [screws] (Para 0042) with the portion of the patient and the reference body before the second implant is implanted based on the three dimensional reconstruction of the portion of the patient [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),
the first implant and the second implant having a fixed predefined spatial relationship to one another upon implantation (Figure 8), and
Examiner’s Note: Intramedullary nail and their screws are understood to that a fixed predefined spatial relationship between the two parts as after implantation of both parts operate together in order to treat the hip as shown in Figure 8.
display a virtual representation of the second implant superimposed [registration of fluoroscopic images and coordination of representations of objects in patient space superimposed in the images] (Para 0007) on the reconstructed portion of the patient such that the second implant is displayed as having a virtual fixed predefined spatial relationship to the first implant before the second implant is implanted [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) [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),
the virtual fixed predefined spatial relationship being the same as the fixed predefined spatial relationship between the first implant and the second implant upon implantation (Figure 8; the disclosed parts in Figure 8 supports the predefined spatial relationship being the same since the virtual representation represents the parts in reality) [the representations of the two fragments 2408 and 2410, of the femur in the relative positions and calculated reference lengths and versions 2412. The surgeon will use the nail and screw representations to ensure that the screws are correctly aligned with the femoral neck. The representations of the locking screws can be used as guides for drilling and inserting the screws] (Para 0052) [The geometric relationship between the tool and the nail is known from the calibration step performed earlier] (Para 0051)
wherein the processor is configured to determine the reference body in the fluoroscopic images [system 10 is programmed to be able to determine the three-dimensional coordinates of an endpoint or tip of a tool and, optionally, its primary axis using predefined or known (e.g. from calibration) geometrical relationships between trackable markers on the tool] (Para 0023) [Imaging device may be a fluoroscope] (Para 0024)
Marquart fails to specifically teach the implants directly coupled to a reference body and wherein the reference body with the first implant and contacting the first implant. Mire teaches –
the reference body having a contoured surface that is shaped to match a surface contour of the first implant to restrict relative movement between the reference body and the first implant to predetermined degrees of freedom [tracking sensors may be affixed to any of the appropriate portions (FIG. 24B)] (Para 0192 and Figure 24B)
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).
such that the first implant and the reference body move as a single rigid body during positioning of the first implant and imaging (Figure 24B)
Examiner’s Note: The reference body in Figure 24B are not moving around and are rigid. Thus during positioning the implant and the reference body move as a single rigid body.
attaching tracking sensors to implants [a tracking sensor may be attached in block 480 to the selected implant] (Para 0198) 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.
It would have been obvious to one of ordinary skill in the art at the time of the invention to attach the reference body of Marquart to the tibia/femoral implants of Marquart based on the teaching of Mire to attach reference bodies to implants as taught by 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.
Marquart and Mire fails to teach to identify the reference body or the second implant to provide a surgical workflow step based on the identification without operator interaction. However, Barrera teaches wherein the processor is configured to identify the reference body or the second implant [The system will in a block 102 identify the surgical instruments brought within the view of the surgical navigation system] (Para 0016) [Identify component] Figure 1, Element 106) to provide a surgical workflow step based on the identification without operator interaction [Once the block 104 has determined what particular step is to be performed next, a block 106 will jump directly to that point within the procedure] (Para 0016) [Identify consequent step of procedure] (Figure 1, Element 104)[Jump to consequent step of procedure] (Figure 1, Element 106) in order to greatly assist the surgeon with their workflow and allow the surgeon to concentrate upon the surgery at hand and minimize the surgeon's interaction with the computer system (Para 0016)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Marquart and Mire to include the workflow automation as taught by Barrera in order to greatly assist the surgeon with their workflow and allow the surgeon to concentrate upon the surgery at hand and minimize the surgeon's interaction with the computer system (Para 0016)
Examiner’s Note: The component of Barrera comprises a reference body or an implant. Barrera incorporates Malackowski by reference. Within Malackowski, implants are specifically disclosed in Para 0131 and the Abstract. Thus supporting that the component of Barrera comprises a reference body or an implant.
Marquart, Mire and Barrera fails to teach identifying the reference body or the second implant through a pattern recognition of the markers. However, Goldbach teaches to identify the reference body or second implant through a pattern recognition of the markers [marker based surgical image-assistance systems and/or medical navigation systems…using videometric pattern recognition technology] (Para 0015) in order to increase safety and efficiency (Para 0015)
Examiner’s Note: While Goldbach is directed to an optical tacking system, Marquart teaches how navigation systems can take many different forms such as optical, electromagnetic, radiographic or acoustical (Para 0003-0006). It is understood that changing between modalities is obvious.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Marquart, Mire and Barrera to include the identifying as taught by Goldbach in order to increase safety and efficiency (Para 0015).
Claim 2/1: Marquart teaches wherein the virtual representation of the second implant superimposed on the reconstructed portion of the patient includes a location [The surgeon will use the nail and screw representations to ensure that the screws are correctly aligned with the femoral neck] (Para 0052) and a length of the second implant before the second implant is implanted [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. The surgeon is permitted to change, shift, rotate and move the representation of the screws in order to check its fit] [assist the surgeon with selecting a nail of appropriate length and screw dimensions] (Para 0042 and Figure 6, Element 628; Display nail and screw representations on proximal end of injured leg for confirmation of screw lengths) .
Examiner’s Note: Correct alignment would require a location.
Claim 4/1: Marquart teaches wherein the first implant is locking nail and 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 6/1: Marquart teaches wherein the reference body is attachable [position of one or more trackable markers disposed on, incorporated into, or inherently a part of surgical tools or instruments 20 with respect to a three-dimensional coordinate frame of reference] (Para 0023) to an aiming device [trackable user input device] (Para 0028), the reference body defining a characteristic two-dimensional projection [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 7/1: Marquart fails to teach contouring. However, Mire teaches wherein the processor is configured to processes the first and second two-dimensional fluoroscopic images [fluoroscopic C-arm imaging device] (Para 0019) by outlining contours of a region of interest in a portion of the patient in two dimensions [perform 2D to 3D registration by utilizing the acquired 2D images to register 3D volume images by use of contour algorithms] (Para 0069) and creates a three dimensional object representing the region of interest [to obtain various two-dimensional images along different planes in order to generate representative two-dimensional and three-dimensional images] (Para 0051) [a patient specific model] [thereby providing an initial 2-D or 3-D model representing a typical anatomical femur] (Para 0076) in order to correlate the position of the instrument on the patient to the position on the diagnostic images (Para 0069) in order to help guide a physician in performing a surgical procedure (Para 0003)
It would have been obvious to one of ordinary skill in the art at the time of the invention to add the steps of contouring as taught by Mire to the surgical procedure of Marquart in order to correlate the position of the instrument on the patient to the position on the diagnostic images (Para 0069) in order to help guide a physician in performing a surgical procedure (Para 0003).
Claim 8/7/1: Marquart teaches wherein the three dimensional object comprises a sphere [two-dimensional projection of a series of nested, virtual spheres in the three dimensional space of the patient] (Para 0040).
Claim 10/7/1: Marquart fails to teach a landmarks. However, Mire teaches wherein the three dimensional object is determined based on landmarks associated with the region of interest (Para 0069) in order to correlate the position of the instrument on the patient to the position on the diagnostic images (Para 0069) in order to help guide a physician in performing a surgical procedure (Para 0003)
It would have been obvious to one of ordinary skill in the art at the time of the invention to substitute the landmark registering procedure as taught by Mire with the fiducial marker registering procedure of Marquart in order to correlate the position of the instrument on the patient to the position on the diagnostic images (Para 0069) in order to help guide a physician in performing a surgical procedure (Para 0003).
Claim 11/1: Marquart teaches wherein the system is adapted for automatically detecting a status of an operation and determining next operative steps to be performed so as to provide a reactive system [a surgeon may be automatically prompted to perform certain tasks] (Para 0025)[the program may automatically detect the stage of the procedure by recognizing the instrument picked up by a surgeon and move immediately to the part of the program in which that tool is used] (Para 0026).
Claim 12/1: Marquart teaches wherein the system is configured to provide suggestions to a surgeon with respect to a specific size based on a detected geometry of a fracture [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 13/12/1: Marquart teaches wherein the system is adapted to modify a previous suggestion based on additional information determined during the surgery [If the fit is not correct, the surgeon can change the end points and/or select a different nail, as indicated by steps 614 and 616] (Figure 6, Element 616 & 614 and Para 0042).
Claim(s) 3 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); Mire et al. (U.S. Patent Application 2004/0171924 A1); Barrera (U.S. Patent Application 2005/0145257 A1) and Goldbach (U.S. Patent Application 2008/0185430 A1) and further in view of Lloyd (U.S. Patent Application 2008/0119725 A1).
Claim 3/2/1: Marquart teaches wherein the virtual representation of the second implant superimposed on the reconstructed portion of the patient [registration of fluoroscopic images and coordination of representations of objects in patient space superimposed in the images] (Para 0007) and the virtual representation 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) [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).
Marquart, Mire, Barrera and Goldbach fail to teach virtual tick marks. However, Lloyd teaches virtual tick marks [a sequence of tick marks] (Para 0064) that indicate the length [indicating the number of millimeters] (Para 0064) of the implant before the implant is implanted [pre-surgical planning] (Para 0005 and Figure 4), the virtual tick marks being located adjacent the implant (See Figure 4) in order to improve the accuracy of tracked instruments (Abstract)
It would have been obvious to one of ordinary skill in the art at the time of the invention to add the virtual tick marks as taught by Lloyd to the virtual representation as taught by Marquart, Mire, Barrera and Goldbach in order to improve the accuracy of tracked instruments (Abstract of Lloyd).
Claim(s) 5 & 9 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); Mire et al. (U.S. Patent Application 2004/0171924 A1); Barrera (U.S. Patent Application 2005/0145257 A1) and Goldbach (U.S. Patent Application 2008/0185430 A1) and further in view of Rubbert et al. (JP 2004/504077 A; enclosed herein).
Claim 5/1: Marquart teaches the second implant is a screw [screws] (Para 0042). Marquart, Mire, Barrera and Goldbach fail 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/Mire 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/Mire) 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/Mire) 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, Mire, Barrera and Goldbach 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 9/8/7/1: Marquart, Mire, Barrera and Goldbach fail to teach the database based on age and gender of the patient. However, Rubbert teaches wherein the three dimensional object is derived from a database and based on age and gender of the patient [library based on ethnicity, gender, age, or other factors] (Para 0233) [virtual template teeth may be based on information such as age or ethnicity] (Para 0242) in order to obtain in a virtual tooth model that substantially matches the structure of the patient's teeth (Para 0235)
It would have been obvious to one of ordinary skill in the art at the time of the invention to generate the representation based on the age/gender database as taught by Rubbert into the representation generation steps as taught by Marquart, Mire, Barrera and Goldbach in order to obtain in a virtual tooth model that substantially matches the structure of the patient's teeth (Para 0235) as it would be beneficial to have accurate patient’s models for treatment planning/procedures.
Claim(s) 14-16 & 18-20 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) and Barrera (U.S. Patent Application 2005/0145257 A1; Para 0017 of Barrera incorporates by reference: Malackowshi et al. (U.S. Patent Application 2003/0093103 A1)).
Claim 14: Marquart teaches –
A method of implanting first and second implants, the method comprising the steps of:
positioning the first implant and the reference body [trackable elements] (Para 0023) in a target surgical site of a patient [providing feedback to the surgeon on the position of the nail during the nail insertion] (Para 0033) using fluoroscopic images taken along at least two dimensions [two-dimensional fluoroscopic images] (Para 0003) [multiple images are usually taken from different angles and registered to each other so that a representation of the tool or other object] (Para 0007);
the reference body having at least four (See Figure 27, which displays a reference body having four trackable markers) radiopaque fiducial markers [radio-opaque fiducials having a known geometric relationship] (Para 0007) [geometrical relationships between trackable markers] (Para 0023) arranged in a three-dimensional pattern, the reference body in a known spatial relationship with the first implant [With information from the tracking system on the location of the trackable markers, CAS system 10 is programmed to be able to determine the three-dimensional coordinates of an endpoint or tip of a tool and, optionally, its primary axis using predefined or known (e.g. from calibration) geometrical relationships between trackable markers on the tool and the end point and/or axis of the tool] (Para 0023);
generating an image showing a position of a virtual first implant and an associated virtual second implant relative to the target surgical site based on the fluoroscopic images [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 the position of the reference body [With information from the tracking system on the location of the trackable markers, CAS system 10 is programmed to be able to determine the three-dimensional coordinates of an endpoint or tip of a tool ] (Para 0023),
the virtual first implant corresponding to the first implant [an IM nail implantation] (Para 0031) and the virtual second implant corresponding to a second implant [screws] (Para 0042);
[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)
affixing the first implant to the target surgical site using the second implant [implantation of an IM nail into the femur] (Para 0030) [insert screws for locking the distal end of the nail] (Para 0035), and
performing a quality check by detecting and displaying the first and second implants relative to the desired position of the first and second implant [The surgeon is then permitted to change, shift, rotate and move the representation in order to check its fit. If the fit is not correct, the surgeon can change the end points and/or select a different nail, as indicated by steps 614 and 616] (Para 0042).
Marquart teaches performing the quality check but fails to teach checking the actual location of the implants after implantation. However, Mire teaches performing a quality check by detecting and displaying the actual location of the first and second implants relative to their desired position [tracking sensors may be used to track a position of the implant such that the position or characteristic of the implant can be substantially verified or confirmed after the implant has been positioned relative to the anatomy to ensure that the implant has been positioned in a preselected portion of the anatomy in a preselected manner] (Para 0217) in order to ensure that the implant has been positioned in as desired [in a preselected manner] (Para 0217), which would improve surgical outcomes.
It would have been obvious to one of ordinary skill in the art at the time of the invention to add an additional quality check after the implantation of the implant as taught by Mire to the surgical procedure of Marquart in order to ensure that the implant has been positioned in as desired [in a preselected manner] (Para 0217), which would improve surgical outcomes.
Marquart fails to teach coupling a first implant and a reference body such that the reference body contact the first implant. However, Mire teaches –
coupling a first implant and a reference body such that the reference body contact the first implant [a tracking sensor may be attached in block 480 to the selected implant] (Para 0198),
wherein coupling the first implant and the reference body includes physically attaching the reference body to the first implant before positioning the first implant (Compare the flow chart of Figure 21 where the Connect Step 480 is before the Perform Implantation Step 492),
the reference body defining a contoured interface corresponding with a surface of 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 attach the reference body of Marquart to the tibia/femoral implants of Marquart based on the teaching of Mire to attach reference bodies to implants as taught by 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.
Marquart and Mire fails to teach to provide a surgical workflow step based on identifying the reference body or the second implant. However, Barrera teaches providing a surgical workflow step [Identify consequent step of procedure] (Figure 1, Element 104) based on identifying the reference body or the second implant [The system will in a block 102 identify the surgical instruments brought within the view of the surgical navigation system] (Para 0016) [Identify component] Figure 1, Element 106), wherein the step of providing a surgical workflow step is performed without operator interaction [Once the block 104 has determined what particular step is to be performed next, a block 106 will jump directly to that point within the procedure] (Para 0016) [Jump to consequent step of procedure] (Figure 1, Element 106) in order to greatly assist the surgeon with their workflow and allow the surgeon to concentrate upon the surgery at hand and minimize the surgeon's interaction with the computer system (Para 0016)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Marquart and Mire to include the workflow automation as taught by Barrera in order to greatly assist the surgeon with their workflow and allow the surgeon to concentrate upon the surgery at hand and minimize the surgeon's interaction with the computer system (Para 0016)
Examiner’s Note: The component of Barrera comprises a reference body or an implant. Barrera incorporates Malackowski by reference. Within Malackowski, implants are specifically disclosed in Para 0131 and the Abstract. Thus supporting that the component of Barrera comprises a reference body or an implant.
Claim 15/14: Marquart teaches further including a step of repositioning any of the first and second implants based on the step of performing the quality check [If the fit is not correct, the surgeon can change the end points and/or select a different nail, as indicated by steps 614 and 616] (Para 0042).
Claim 16/14: Marquart teaches wherein the first implant is a locking nail and 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 18/14: Marquart teaches wherein the reference body is attachable [position of one or more trackable markers disposed on, incorporated into, or inherently a part of surgical tools or instruments 20 with respect to a three-dimensional coordinate frame of reference] (Para 0023) to an aiming device [trackable user input device] (Para 0028).
Claim 19/18/14: Marquart teaches wherein the reference body defines a characteristic two-dimensional projection [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 20/18/14: Marquart teaches wherein the reference body includes fiducial markers [Markers can take several forms, including those that can be located using…radio…methods] (Para 0004 & 0007).
Claim(s) 17 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); Mire et al. (U.S. Patent Application 2004/0171924 A1), Barrera (U.S. Patent Application 2005/0145257 A1) and further in view of Rubbert et al. (JP 2004/504077 A; enclosed herein and English Translation provided herein referenced).
Claim 17/14: Marquart teaches the second implant is a screw [screws] (Para 0042). Marquart, Mire and Barrera fail 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/Mire 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/Mire) 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/Mire) 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, Mire and Barrera 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).
Response to Arguments
Applicant's arguments filed 11/20/2025 have been fully considered but they are not persuasive. The Applicant submitted arguments that the cited prior art fail to teach or suggest all limitation of amended independent claims 1 & 14. The Examiner respectfully disagrees and in response has cited in the rejection above, where the prior art teaches the new amended claimed subject matter. However, the new claim limitation direct to patter recognition required the new reference of Goldbach (U.S. Patent Application 2008/0185430 A1). The Applicant merely stated that the claim limitations were not taught and did not expand upon the argument further. As a result, the Examiner contends the arguments are unconvincing.
Conclusion
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/Helene Bor/Examiner, Art Unit 3797
/CHRISTOPHER KOHARSKI/Supervisory Patent Examiner, Art Unit 3797