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 .
STATUS OF CLAIMS
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
Claims 12, 16, and 20 have been cancelled.
Claims 1, 2, 6, 9, 10, 13, 14, 15, 18, and 19 have been amended. Claims 21-23 are newly added.
Claims 1-11, 13-15, 17-19, and 21-23 are pending.
Rejections and Objections Withdrawn
Applicant’s amendments to the Specification, specifically the Abstract, Title, and paragraphs [0075], [0090], and [0092] are accepted. The objections to the specification are withdrawn.
In light of the claim amendments, the objections to claims 2 and 10 are withdrawn. However, there is a new claim objection noted below.
In light of the claim amendments, the Section 112(b) rejections are also withdrawn.
Claim Objections
Claim 22 is objected to because of the following informalities:
To be consistent with the other verbs beginning the operations, claim 22 should read “ output the second path…”
Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: tracking system in claims 1, 13, and 15.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
Corresponding structure is described at [0043]: “[T]he tracking system including either or both of the electromagnetic (EM) localizer 94 and/or the optical localizer 88. The tracking systems may include a controller and interface portion 110. The controller 110 can be connected to the processor portion 102, which can include a processor included within a computer.” Tracking systems are also described at [0034], [0035], and [0046].
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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.
Claims 1-11, 13-15, 17-19, and 21-23 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception without significantly more. The claims recite:
[a] generating/reconstructing a model of the subject based at least on the acquired image data; (claims 1, 13, 18)
[b] tracking a reference marker, connected to the subject, with a tracking system; (claim 1)
[c] determining a volume (or external geometry) defined by the subject of the generated model; (claims 1, 13, 18)
[d] defining a no-go region relative to the determined volume/geometry; (claims 1, 13, 18)
[e] tracking the moveable portion relative to the defined no-go region; (claim 1)
[f] determining a pose of the moveable portion relative or the defined no-go region; (claims 2, 13)
[g] determine a path from a current pose of the moveable portion to a second pose that moves the moveable portion only in the go region; (claim 18 with similar recitation in claim 6);
[h] determining a first path between a current pose and a second pose relative to a no-go region, evaluating whether it passes the no-go region, and determining a second path when the first path goes through the no-go region; (claim 21 (depending from claim 7), claim 22, and claim 23 (depending from claim 19).
Claim limitation [a], as drafted and under its broadest reasonable interpretation, recites a mathematical concept and/or mental process. (MPEP 2106.04(a)(2) (see, e.g., Digitech Image Techs., LLC v. Electronics for Imaging, Inc., 758 F.3d 1344, 1350, 111 USPQ2d 1717, 1721 (Fed. Cir. 2014) (although the claims did not recite a particular mathematical formula, the court held “[w]ithout additional limitations, a process that employs mathematical algorithms to manipulate existing information to generate additional information is not patent eligible.”)). For instance, generating or reconstructing a model involves processing multiple 2D slices acquired by an imaging modality (e.g., CT or MRI), segmenting the images to identify anatomical structures using various algorithms (e.g., region growing, thresholding, watershed), and reconstructing a 3D volume image using other algorithms (e.g., marching cubes).
Claim limitation [b], as drafted and under its broadest reasonable interpretation, recites a mathematical concept and/or mental process. (MPEP 2106.04(a)(2) (see, e.g., Digitech Image Techs., LLC v. Electronics for Imaging, Inc., 758 F.3d 1344, 1350, 111 USPQ2d 1717, 1721 (Fed. Cir. 2014) (although the claims did not recite a particular mathematical formula, the court held “[w]ithout additional limitations, a process that employs mathematical algorithms to manipulate existing information to generate additional information is not patent eligible.”)). For example, tracking a reference marker involves transforming data from one coordinate system to another, obtaining raw position data and calculating a position within a coordinate system (e.g., using triangulation with images from multiple camera and/or by solving magnetic field equations when using an electromagnetic tracker). (see also, e.g., Burnett v. Panasonic Corp., 741 Fed. Appx. 777, 780 (Fed. Cir. 2018) (non-precedential) (claims reciting a formula to convert geospatial coordinates into natural numbers are patent ineligible).
Claim limitation [c], as drafted and under its broadest reasonable interpretation, recites a mathematical concept and/or mental process. (MPEP 2106.04(a)(2) (see, e.g., Digitech Image Techs., LLC v. Electronics for Imaging, Inc., 758 F.3d 1344, 1350, 111 USPQ2d 1717, 1721 (Fed. Cir. 2014) (although the claims did not recite a particular mathematical formula, the court held “[w]ithout additional limitations, a process that employs mathematical algorithms to manipulate existing information to generate additional information is not patent eligible.”)). For example, determining a volume (or external geometry) of the subject based on the generated model includes calculating a volume using dimensions determined from the model.
Claim limitation [d], as drafted and under its broadest reasonable interpretation, recites a mathematical concept and/or mental process. (MPEP 2106.04(a)(2) (see, e.g., Digitech Image Techs., LLC v. Electronics for Imaging, Inc., 758 F.3d 1344, 1350, 111 USPQ2d 1717, 1721 (Fed. Cir. 2014) (although the claims did not recite a particular mathematical formula, the court held “[w]ithout additional limitations, a process that employs mathematical algorithms to manipulate existing information to generate additional information is not patent eligible.”)). For example, defining a no-go region relative to the determined volume/geometry may include identifying organs or tissue that should be avoided during using the image data. Moreover, the claim limitation recites a mental process that can include evaluations, judgments, and/or opinions. (MPEP 2106.04(a)(2),III) More specifically, defining a no-go region relative to the determined volume/geometry can be performed by a doctor after evaluating the images.
Claim limitation [e], as drafted and under its broadest reasonable interpretation, recites a mathematical concept and/or mental process. (MPEP 2106.04(a)(2) (see, e.g., Digitech Image Techs., LLC v. Electronics for Imaging, Inc., 758 F.3d 1344, 1350, 111 USPQ2d 1717, 1721 (Fed. Cir. 2014) (although the claims did not recite a particular mathematical formula, the court held “[w]ithout additional limitations, a process that employs mathematical algorithms to manipulate existing information to generate additional information is not patent eligible.”)). Like claim limitation [b], tracking the moveable portion relative to the defined no-go region involves transforming data from one coordinate system to another, obtaining raw position data and calculating a position within a coordinate system (e.g., using triangulation with images from multiple camera and/or by solving magnetic field equations when using an electromagnetic tracker), and comparing that position to the no-go region. (see also, e.g., Burnett v. Panasonic Corp., 741 Fed. Appx. 777, 780 (Fed. Cir. 2018) (non-precedential) (claims reciting a formula to convert geospatial coordinates into natural numbers are patent ineligible).
Claim limitation [f], as drafted and under its broadest reasonable interpretation, recites a mathematical concept and/or mental process. (MPEP 2106.04(a)(2) (see, e.g., Digitech Image Techs., LLC v. Electronics for Imaging, Inc., 758 F.3d 1344, 1350, 111 USPQ2d 1717, 1721 (Fed. Cir. 2014) (although the claims did not recite a particular mathematical formula, the court held “[w]ithout additional limitations, a process that employs mathematical algorithms to manipulate existing information to generate additional information is not patent eligible.”)). Like claim limitations [b] and [e], determining a pose of the moveable portion relative to the defined no-go region involves transforming data from one coordinate system to another, obtaining raw position data and calculating a position within a coordinate system (e.g., using triangulation with images from multiple camera and/or by solving magnetic field equations when using an electromagnetic tracker), and comparing that position to the no-go region.
Claim limitations [g] and [h], as drafted and under their broadest reasonable interpretation, recite a mathematical concept and/or mental process. (MPEP 2106.04(a)(2) (see, e.g., Digitech Image Techs., LLC v. Electronics for Imaging, Inc., 758 F.3d 1344, 1350, 111 USPQ2d 1717, 1721 (Fed. Cir. 2014) (although the claims did not recite a particular mathematical formula, the court held “[w]ithout additional limitations, a process that employs mathematical algorithms to manipulate existing information to generate additional information is not patent eligible.”)). For example, determining a path of movement with respect to the no-go region can involve analyzing the model to determine if the no-go region or go region are between the current position and a subsequent position, analyzing the type of tissue, determining a path that avoids the no-go region, and generating a sequence of commands for moving the robotic system along the determined path. Evaluating whether a current path pass through a no-go region involves a similar analysis.
This judicial exception is not integrated into a practical application. Additional elements include: (1) the step of acquiring image data (claims 1, 13, 18); (2) the step of positioning the robotic system relative to the subject; (3) a tracking system; (4) a reference marker configured to be tracked by the tracking system; and (5) a processor that is configured to execute instructions (claim 13).
A claim that integrates a judicial exception into a practical application will apply, rely on, or use the judicial exception in a manner that imposes a meaningful limit on the judicial exception, such that the claim is more than a drafting effort designed to monopolize the judicial exception. (MPEP 2106.04(d)).
However, in this case, the claim limitations (1) and (2) to the steps of acquiring image data and positioning the robotic system, respectively, recite insignificant extra-solution activities (i.e., pre-solution activities) that do not impose any meaningfully limits on the claim. (MPEP 2106.04(d)(I), which also refers to MPEP 2106.05(f)). Claims limitations (3) and (4) to the tracking system and the reference marker, respectively, are merely reciting words equivalent to “apply it” with the judicial exceptions. (MPEP 2106.04(d)(I), which also refers to MPEP 2106.05(f)). Claim limitation (5) recites a processor that is configured to execute instructions to implement the abstract idea on a computer and/or merely use a computer as a tool to perform an abstract idea. (MPEP 2106.04(d)(I), which also refers to MPEP 2106.05(f)).
Applicant amended claims 1, 13, and 18 to recite moving the moveable portion without passing through the no-go region (or only within the go region). This is also an additional element and is an example of an insignificant post-solution activity (i.e., implementing the plan created by the judicial exception). (MPEP 2106.04(d)(I)).
Moreover, the claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. A shared quality of the additional elements and/or steps is that they do not recite any meaningful limitation that transforms the judicial exception into a patent-eligible application. (MPEP 2106.05(II)). As explained above, claim limitations (1) and (2) recite insignificant pre-solution activities. Acquiring image data and positioning the robotic system are also well-understood, routine, and conventional activities in the field of robotic surgical systems. Claim limitations (3) and (4) merely recite words that are equivalent to “apply it,” and claim limitation (5) recites a generic element for computing. Newly added claim limitations merely follow-through the plan determined by the judicial exception. Each of these limitations is recited without any specificity or additional limitations and/or at a high level of generality. They do not meaningfully limit the judicial exception.
Accordingly, claims 1, 13, and 18 do not include patent-eligible subject matter.
Dependent claims 2-12, 14-17, and 20 also fail to recite patent-eligible subject matter.
With respect to claim 2, the claim limitation “tracking the reference marker to determine a pose of at least one of the determined volume defined by the subject or the defined a no-go region” also recites a mathematical concept and/or mental process. (MPEP 2106.04(a)(2) (see, e.g., Digitech Image Techs., LLC v. Electronics for Imaging, Inc., 758 F.3d 1344, 1350, 111 USPQ2d 1717, 1721 (Fed. Cir. 2014). Like claim limitation [e] and [f], tracking the reference marker to determine a pose involves transforming data from one coordinate system to another, obtaining raw position data and calculating a position within a coordinate system (e.g., using triangulation with images from multiple camera and/or by solving magnetic field equations when using an electromagnetic tracker), and comparing that position to the no-go region.
With respect to claims 3 and 4, the claim limitation “registering a robotic coordinate system” to the subject or to an image space and other registering steps recites a mathematical concept and/or mental process. (MPEP 2106.04(a)(2) (see, e.g., Digitech Image Techs., LLC v. Electronics for Imaging, Inc., 758 F.3d 1344, 1350, 111 USPQ2d 1717, 1721 (Fed. Cir. 2014). For example, registering a robotic coordinate system to the subject and/or the image space includes calculating transformations to map any point of the patient’s coordinate system to the robotic coordinate system.
With respect to claim 5, the claim limitations “displaying a graphical representation of the moveable portion relative to an image” recites an additional element or step. However, displaying graphical representations is a post-solution activity that merely provides the result determined by a judicial exception. (MPEP 2106.04(d)(I), which also refers to MPEP 2106.05(f)). Claim 5 does not impose a meaningful limit on the judicial exceptions.
With respect to claim 6, the steps of “performing at least a first portion of a procedure with the moveable portion in a first position at a first time” and “moving the moveable portion to a second position at a second time” are limitations recited at a high level of generality that are also pre-solution activities that are necessary to be performed for the judicial exception. (MPEP 2106.04(d)(I), which also refers to MPEP 2106.05(f)).
With respect to claims 6, 7, and 19, the step of “determining a path of movement of the moveable portion to the second position from the first position that does not pass through the no-go region” is similar to claim limitation [g], as discussed above, and recites a mathematical concept and/or mental process. (MPEP 2106.04(a)(2) (see, e.g., Digitech Image Techs., LLC v. Electronics for Imaging, Inc., 758 F.3d 1344, 1350, 111 USPQ2d 1717, 1721 (Fed. Cir. 2014). Determining a path of movement that does not pass through the no-go region can involve analyzing the model to determine if the no-go region or go region are between the current position and the second position, analyzing the type of tissue, determining a path that avoids the no-go region, and generating a sequence of commands for moving the robotic system along the determined path. Claims 7 and 19 then merely repeats the judicial exception previously recited to determine another path.
With respect to claim 8, the claim limitation “outputting the determined path to control movement of the moveable portion including providing commands to drive mechanisms” recites post-solution activity. (MPEP 2106.04(d)(I), which also refers to MPEP 2106.05(f)). After determining the path, it is necessary to output instructions for completing the path by the moveable portion. Moreover, claim 8 is recited at a high level of generality. It does not impose a meaningful limit on the judicial exceptions.
With respect to claims 9 and 20, the claim limitation “receiving an input from the user regarding the no-go region [or go region]” recites pre-solution activity. (MPEP 2106.04(d)(I), which also refers to MPEP 2106.05(f)). Claims 9 and 20 are also recited at a high level of generality and does not impose a meaningful limit on the judicial exceptions.
With respect to claim 10, the claim limitation “operating the robotic system to move the moveable portion to move alone the determined path” recites post-solution activity. (MPEP 2106.04(d)(I), which also refers to MPEP 2106.05(f)). After determining the path, it is necessary to operate the robotic system for completing the path by the moveable portion. Moreover, claim 10 is recited at a high level of generality. It does not impose a meaningful limit on the judicial exceptions.
With respect to claim 11, the claim limitation “positioning an end effector of the moveable portion via the determined path” recites post-solution activity. (MPEP 2106.04(d)(I), which also refers to MPEP 2106.05(f)). After determining the path, it is necessary to operate the robotic system for completing the path by the moveable portion. Moreover, claim 11 is recited at a high level of generality. An “end effector” is a generic term that could apply to many tools used during robotic surgery. Claim 11 does not impose a meaningful limit on the judicial exceptions.
With respect to claim 12, the claim limitation “providing the robotic system relative to the subject” recites pre-solution activity. (MPEP 2106.04(d)(I), which also refers to MPEP 2106.05(f)). It is assumed that the robotic system will be positioned “relative to” the subject during surgery. Claim 12 does not impose a meaningful limit on the judicial exceptions.
With respect to claims 14 and 15, the claim limitations “the robotic system configured to be fixed relative to the subject” and “the robotic system configured to be tracked by the tracking system to determine the pose of the moveable portion” (see Section 112(b) rejection above) recites pre-solution activity. (MPEP 2106.04(d)(I), which also refers to MPEP 2106.05(f)). First, it is assumed that the robotic system will be “configured to be tracked by the tracking system to determine the pose” during surgery. Second, the limitation “fixed relative to the subject” is recited at a high level of generality and could include any portion of a robotic system. Neither claim 14 nor claim 15 impose a meaningful limit on the judicial exceptions.
With respect to claim 16, the claim limitation “an imaging system configured to capture the image data” recites an additional element that is intended to perform pre-solution activity (i.e., acquiring image data). (MPEP 2106.04(d)(I), which also refers to MPEP 2106.05(f)). Moreover, the imaging system is recited generally without any specifics. Claim 16 does not impose a meaningful limit on the judicial exceptions.
With respect to claim 17, the claim limitation “determining an external geometry of the subject based on the acquired image data” is similar to claim limitation [c] and recites a mathematical concept and/or mental process. (MPEP 2106.04(a)(2) (see, e.g., Digitech Image Techs., LLC v. Electronics for Imaging, Inc., 758 F.3d 1344, 1350, 111 USPQ2d 1717, 1721 (Fed. Cir. 2014). For example, determining an external geometry of the subject based on the acquired image data identifying the exterior of the volume determined from the model.
Accordingly, none of claims 1-20 recite eligible subject matter.
RESPONSE TO APPLICANT’S ARGUMENTS
Applicant did not specifically argue that Examiner’s analysis of the claimed invention was incorrect in the Non-Final Office Action but asserts that the amended claims recite patentable subject matter. Examiner disagrees. The added step of moving the moveable portion along the determined path is insignificant post-solution activity (i.e., implementing the plan created by the judicial exception). (MPEP 2106.04(d)(I)). Moreover, the steps added in claims 21-23 are repeated iterations of the same planning and analysis steps that are examples of mathematical concepts and/or mental processes (i.e., an abstract idea) as explained above.
Claim Rejections - 35 USC § 102
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, 2, 13, and 17 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Appl. Publ. No. 2022/0125517 A1 (hereinafter “ZIMMERMANN”) and U.S. Patent No. 11,202,682 B2 (hereinafter “STAUNTON”).
ZIMMERMANN teaches a method of compensating for motion of objects during a surgical procedure is provided. (Abstract). The procedure can be carried out by a surgical system 100 that is capable of “image analysis, surgical planning, registration, navigation, image guidance, and haptic guidance.” ([0089]; see also Figure 1 and [0083]). While the embodiments of ZIMMERMANN are described with respect to knee surgeries, ZIMMERMANN teaches that embodiments may be applied to other types of surgeries, including spinal surgeries. “[T]he concepts taught herein are equally applicable to any type of joint such as, for example but not by way of limitation, spine, shoulder, elbow, wrist, hip, ankle, etc.” ([0155]; see also [0131], [0153], [0198]). Furthermore, while ZIMMERMANN is primarily concerned with assisting a surgeon as the surgeon performs a procedure, ZIMMERMANN also teaches that the system can be a surgical robot. “More particularly, the navigation system may operate in conjunction with an autonomous robot or a surgeon-assisted device (haptic device) in performing the arthroplasty procedure.” ([0088]). “In certain embodiments, the device 60 may be an autonomous robot, as opposed to surgeon-assisted. That is, a tool path, as opposed to haptic boundaries, may be defined for resecting the bones and drilling holes since an autonomous robot may only operate along a pre-determined tool path such that there is no need for haptic feedback.” ([0117]).
With respect to claim 1 (and in light of the Section 112(b) rejection), ZIMMERMANN teaches a method for determining movement of and moving at least a moveable portion of a robotic system to at least minimize contact with portions exterior to the robotic system. The surgical system is capable of tracking “the patient’s bone (i.e., tibia 10, femur 11), as well as surgical tools (e.g., pointer device, probe, cutting tool) utilized during the surgery, to allow the surgeon to visualize the bone and tools on a display 56 during the osteotomy procedure.” ([0083]). With respect to the phrase “to at least minimize contact with portions exterior to the robotic system…,” Examiner is interpreting this as a statement within the preamble that recites the purpose or intended use of the claimed invention that does not result in a manipulative difference. (see MPEP 2111.02, II: “During examination, statements in the preamble reciting the purpose or intended use of the claimed invention must be evaluated to determine whether or not the recited purpose or intended use results in a structural difference (or, in the case of process claims, manipulative difference) between the claimed invention and the prior art.” (emphasis added)). It is also noted that at least one purpose of preoperative planning is “to increase the effectiveness and efficiency of the particular procedure. In particular, preoperative planning may increase the accuracy of bone resections and implant placement while reducing the overall time of the procedure and the time the patient joint is open and exposed.” ([0003]).
ZIMMERMANN teaches acquiring image data of a subject (“…prior to performance of an arthroplasty, the patient’s anatomy may be scanned using any known imaging technique, such as CT or MRI (Step 801) captured with a medical imaging machine.”([0089])); generating a model of the subject based on the acquired image data (“…the scan data is then segmented to obtain a three-dimensional representation of the patient’s anatomy. For example, prior to performance of a knee arthroplasty, a three-dimensional representation of the femur and tibia is created. Using the three-dimensional representation and as part of the planning process, femoral and tibial landmarks can be selected….” (emphasis added) ([0090]))); tracking a reference marker, connected to the subject, with a tracking system (“The non-mechanical tracking system is an optical tracking system with a detection device 44 and trackable elements (e.g. navigation markers 46, 47) that are respectively disposed on tracked objects (e.g., patient tibia 10 and femur 11) and are detectable by the detection device 44.” (emphasis added) ([0083])).
ZIMMERMANN also teaches determining a volume defined by the subject based on the generated model. “In certain instances, the preoperative plan may involve generating a three-dimensional (“3D”), patient specific, model of the patient bone(s) and soft tissue to undergo the joint replacement.” ([0005]). “Aspects of the present disclosure may also include an algorithm able to co-register simultaneously bone surfaces of N bones (typically forming a joint) between an ultrasound modality and a second modality (e.g. CT/MRI, or surface reconstruction employing one or more statistical/generic models morphed according to patient anatomical data)….” ([0009]).
ZIMMERMANN also teaches defining a no-go region relative to the determined volume (“Surgical registration entails mapping of virtual boundaries, determined in preoperative planning, for example, with working boundaries in physical space. A surgical robot may be permitted to perform certain actions within the virtual boundaries, such as boring a hole or resecting a bone surface.” ([0079]))). NOTE: While the virtual or working boundaries define where the tool may be operated (i.e., the go regions), the regions beyond the virtual or working boundaries define where the tool may not operate (i.e., the no-go regions). “For example, the surgical system 100 may assist the surgeon by substantially preventing or constraining the surgical tool 58 from crossing a working boundary.” ([0108]). This is consistent with Applicant’s disclosure. (see, e.g., [0070]: “As discussed herein, moving in and/or only moving in the Go Zone includes not moving in the No-Go Zone” and also [0086]: “Thus, the Go and No-Go Zones may be selected three-dimensional volumes between and/or relative to selected boundaries.”).
ZIMMERMANN also teaches tracking the moveable portion relative to the defined no-go region. “During haptically guided robotic-assisted surgeries, the navigation system may further include a haptic device marker 48 (to track a global or gross position of the haptic device 60), an end effector marker 54 (to track a distal end of the haptic device 60)….” ([0085]). “Surgical system 100 provides haptic feedback to the surgeon based on a relationship between surgical tool 58 and at least one of the working boundaries.” ([0107]). “In various embodiments, the surgical system 100 provides haptic feedback to the user as the surgical tool 58 approaches a working boundary, upon contact of the surgical tool 58 with the working boundary, and/or after the surgical tool 58 has penetrated the working boundary by a predetermined depth.” ([0109]).
ZIMMERMANN also teaches moving the movable portion without passing the no-go region. “Once the virtual boundaries are mapped to the physical space of the patient, the robot may bore the hole or resect the bone surface in a location and orientation as planned, but may be constrained from performing such actions outside the pre-planned virtual boundaries.” ([0079]). Notably, ZIMMERMANN is not limited to semi-autonomy in which the surgeon is constrained by the system. ZIMMERMANN also teaches that the features can be applied to autonomous systems. “In certain embodiments, the device 60 may be an autonomous robot, as opposed to surgeon-assisted. That is, a tool path, as opposed to haptic boundaries, may be defined for resecting the bones and drilling holes since an autonomous robot may only operate along a pre-determined tool path such that there is no need for haptic feedback.” ([0117]). “The virtual boundaries or toolpath exist in virtual space and can be representative of features existing or to be created in physical (i.e. real) space. Virtual boundaries correspond to working boundaries in physical space that are capable of interacting with objects in physical space.” ([0095]).
With respect to claim 2, ZIMMERMANN also discloses tracking the reference marker to determine a pose of at least one of the determined volume defined by the subject or the defined no-go region. “The non-mechanical tracking system is an optical tracking system with a detection device 44 and trackable elements (e.g. navigation markers 46, 47) that are respectively disposed on tracked objects (e.g., patient tibia 10 and femur 11) [i.e., the determined volume] and are detectable by the detection device 44..” (emphasis added) ([0084]).
With respect to claim 13 (and in light of the Section 112(b) rejection), ZIMMERMANN teaches a system for determining movement of and moving at least a moveable portion of a robotic system to at least minimize contact with portions exterior to the robotic system. The surgical system is capable of tracking “the patient’s bone (i.e., tibia 10, femur 11), as well as surgical tools (e.g., pointer device, probe, cutting tool) utilized during the surgery, to allow the surgeon to visualize the bone and tools on a display 56 during the osteotomy procedure.” ([0083]). With respect to the phrase “to at least minimize contact with portions exterior to the robotic system…,” Examiner is interpreting this as a statement within the preamble that recites the purpose or intended use of the claimed invention that does not result in a manipulative difference. (see MPEP 2111.02, II: “During examination, statements in the preamble reciting the purpose or intended use of the claimed invention must be evaluated to determine whether or not the recited purpose or intended use results in a structural difference (or, in the case of process claims, manipulative difference) between the claimed invention and the prior art.” (emphasis added)). It is also noted that at least one purpose of preoperative planning is “to increase the effectiveness and efficiency of the particular procedure. In particular, preoperative planning may increase the accuracy of bone resections and implant placement while reducing the overall time of the procedure and the time the patient joint is open and exposed.” ([0003]).
ZIMMERMANN teaches a tracking system and a reference marker, connected to a subject, configured to be tracked with the tracking system (“The non-mechanical tracking system is an optical tracking system with a detection device 44 and trackable elements (e.g. navigation markers 46, 47) that are respectively disposed on tracked objects (e.g., patient tibia 10 and femur 11) and are detectable by the detection device 44.” (emphasis added) ([0083])).
ZIMMERMANN teaches a processor (see, e.g., [0203]) configured to execute instructions to acquire image data of the subject (“…prior to performance of an arthroplasty, the patient’s anatomy may be scanned using any known imaging technique, such as CT or MRI (Step 801) captured with a medical imaging machine.”([0089])); generate a model of the subject based at least on the acquired image data (“…the scan data is then segmented to obtain a three-dimensional representation of the patient’s anatomy. For example, prior to performance of a knee arthroplasty, a three-dimensional representation of the femur and tibia is created. Using the three-dimensional representation and as part of the planning process, femoral and tibial landmarks can be selected….” (emphasis added) ([0090]))).
ZIMMERMANN also teaches that the processor is configured to determine a volume defined by the subject based on the generated model and define a no-go region relative to the determined volume (“Surgical registration entails mapping of virtual boundaries, determined in preoperative planning, for example, with working boundaries in physical space. A surgical robot may be permitted to perform certain actions within the virtual boundaries, such as boring a hole or resecting a bone surface.” ([0079]))). NOTE: While the virtual or working boundaries define where the tool may be operated (i.e., the go regions), the regions beyond the virtual or working boundaries define where the tool may not operate (i.e., the no-go regions). “For example, the surgical system 100 may assist the surgeon by substantially preventing or constraining the surgical tool 58 from crossing a working boundary.” ([0108]). This is consistent with Applicant’s disclosure. (see, e.g., [0070]: “As discussed herein, moving in and/or only moving in the Go Zone includes not moving in the No-Go Zone” and also [0086]: “Thus, the Go and No-Go Zones may be selected three-dimensional volumes between and/or relative to selected boundaries.”).
ZIMMERMANN also teaches that the processor is configured to determine a pose of the moveable portion relative to the defined no-go region. The moveable portion in ZIMMERMANN is a haptic device 60 that is “also referred to as a robotic arm 60.” ([0083]). “During haptically guided robotic-assisted surgeries, the navigation system may further include a haptic device marker 48 (to track a global or gross position of the haptic device 60), an end effector marker 54 (to track a distal end of the haptic device 60)….” ([0085]). “Surgical system 100 provides haptic feedback to the surgeon based on a relationship between surgical tool 58 and at least one of the working boundaries.” ([0107]). “In various embodiments, the surgical system 100 provides haptic feedback to the user as the surgical tool 58 approaches a working boundary, upon contact of the surgical tool 58 with the working boundary, and/or after the surgical tool 58 has penetrated the working boundary by a predetermined depth.” ([0109]).
ZIMMERMANN also teaches moving the movable portion without passing through the no-go region. “Once the virtual boundaries are mapped to the physical space of the patient, the robot may bore the hole or resect the bone surface in a location and orientation as planned, but may be constrained from performing such actions outside the pre-planned virtual boundaries.” ([0079]). Notably, ZIMMERMANN is not limited to semi-autonomy in which the surgeon is constrained by the system. ZIMMERMANN also teaches that the features can be applied to autonomous systems. “In certain embodiments, the device 60 may be an autonomous robot, as opposed to surgeon-assisted. That is, a tool path, as opposed to haptic boundaries, may be defined for resecting the bones and drilling holes since an autonomous robot may only operate along a pre-determined tool path such that there is no need for haptic feedback.” ([0117]). “The virtual boundaries or toolpath exist in virtual space and can be representative of features existing or to be created in physical (i.e. real) space. Virtual boundaries correspond to working boundaries in physical space that are capable of interacting with objects in physical space.” ([0095]).
With respect to claim 17, ZIMMERMAN teaches wherein the processor system to define the no-go region relative to the determined volume includes determining an external geometry of the subject based on the acquired image data. “In certain instances, the preoperative plan may involve generating a three-dimensional (“3D”), patient specific, model of the patient bone(s) and soft tissue to undergo the joint replacement. The 3D patient model may be used as a visual aid in planning the various possibilities of implant sizes, implant orientations, implant positions, and corresponding resection planes and depths, among other parameters.” ([0005]) (see also Figure 4A showing an external geometry of the subject and [0096]: “…the navigation and haptics could be preoperatively planned to allow the system disclosed herein to cut out a bone tumor (sarcoma) or make another type of incision or resection in boney or soft tissues in performing generally any type of navigated surgery.”).
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 3-5 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Appl. Publ. No. 2022/0125517 A1 (hereinafter “ZIMMERMANN”) and U.S. Patent Appl. Publ. No. 2007/0270685 A1 (hereinafter “KANG”).
With respect to claim 3, ZIMMERMANN teaches wherein the subject at least in part defines the no-go region. “[T]he virtual boundary 62 representing a resection through a portion of the bone may have an essentially planar shape, with or without a thickness.” The portion of the bone that is not resected is outside of the virtual boundary and, therefore, defines the no-go region.
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However, ZIMMERMANN does not teach registering a robotic coordinate system to the subject.
However, in the same field of endeavor, KANG teaches that “the coordinate transformation process 2506 includes defining various coordinate systems,….Coordinate transformations are then determined that enable coordinates in one coordinate system to be mapped or transformed to another coordinate system.” ([0068]). As such, each of the coordinate systems is registered directly or indirectly with the other coordinate systems, including a robotic coordinate system (taught by the haptic device tracker 45, the end effector tracker 47, and the haptic device 30) and the image space is taught by “a second coordinate system X2 associated with the anatomy (e.g., a bone or an anatomy tracker 43a or 43b affixed to the bone).”
KANG notes that “[b]ecause motion of the anatomy, the haptic device tracker 45, and the arm 33 of the haptic device 30 are continuously monitored, the transformation T6 is regularly updated to reflect motion of the anatomy, the base 32 of the haptic device 30, and the arm 33 of the haptic device 30. In this manner, the surgical system 10 compensates for motion of objects during a surgical procedure.”).
It would have been obvious to one having ordinary skill in the art at the time of invention to register a robotic coordinate system to the subject. One would have been motivated to register the robotic coordinate system to the subject in order to monitor motion of the anatomy and the robotic arm, as taught in KANG. There would have been a reasonable expectation of success as KANG teaches that a robotic system for surgery can have the robotic coordinate system registered to the anatomy.
With respect to claim 4, ZIMMERMANN teaches wherein tracking the moveable portion relative to the defined no-go region includes tracking the moveable portion in the navigation space. “During haptically guided robotic-assisted surgeries, the navigation system may further include a haptic device marker 48 (to track a global or gross position of the haptic device 60), an end effector marker 54 (to track a distal end of the haptic device 60)….” ([0085]). “Surgical system 100 provides haptic feedback to the surgeon based on a relationship between surgical tool 58 and at least one of the working boundaries.” ([0107]). “In various embodiments, the surgical system 100 provides haptic feedback to the user as the surgical tool 58 approaches a working boundary, upon contact of the surgical tool 58 with the working boundary, and/or after the surgical tool 58 has penetrated the working boundary by a predetermined depth.” ([0109]).
However, ZIMMERMANN does not teach the other claim limitations of claim 4.
In the same field of endeavor, KANG teaches registering a robotic coordinate system to an image space defined by the generated model. KANG teaches that “the coordinate transformation process 2506 includes defining various coordinate systems,….Coordinate transformations are then determined that enable coordinates in one coordinate system to be mapped or transformed to another coordinate system.” ([0068]). As such, each of the coordinate systems is registered directly or indirectly with the other coordinate systems, including a robotic coordinate system (taught by the haptic device tracker 45, the end effector tracker 47, and the haptic device 30) and the image space is taught by “a second coordinate system X2 associated with the anatomy (e.g., a bone or an anatomy tracker 43a or 43b affixed to the bone).”
KANG also teaches registering the image space to a navigation space. With all of the coordinate systems registered with respect to one another, KANG is able to track motion of various objects within the navigation space. (see, e.g., [0074] and Figure 13). “Because motion of the anatomy, the haptic device tracker 45, and the arm 33 of the haptic device 30 are continuously monitored, the transformation T6 is regularly updated to reflect motion of the anatomy, the base 32 of the haptic device 30, and the arm 33 of the haptic device 30. In this manner, the surgical system 10 compensates for motion of objects during a surgical procedure.” ([0074].
It would have been obvious to one having ordinary skill in the art at the time of invention to register a robotic coordinate system to the image space (i.e., coordinate system of the imaging data/model) and the image space to the navigation space (i.e., space in which the moveable portion may be tracked). One would have been motivated to register the different coordinate systems to the anatomy and to the navigation space in order to monitor motion of the anatomy and the robotic arm, as taught in KANG. There would have been a reasonable expectation of success as KANG teaches that a robotic system for surgery can have the robotic coordinate system registered to other spaces, including those for the image space and navigation space.
With respect to claim 5, ZIMMERMANN does not explicitly teach displaying a graphical representation of the moveable portion relative to an image.
However, ZIMMERMANN does teach that “[t]he navigation system tracks the patient’s bone (i.e., tibia 10, femur 11), as well as surgical tools (e.g., pointer device, probe, cutting tool) utilized during the surgery, to allow the surgeon to visualize the bone and tools on a display 56 during the osteotomy procedure.” ([0083]).
KANG teaches “[b]ased on registration and tracking data, the surgical system 10 can determine (a) a spatial relationship between the anatomy and the image 614 and (b) a spatial relationship between the anatomy and the tool 50 so that the computing system 20 can superimpose, and continually update, a virtual representation 616 of the tool 50 on the image 614.” Figure 9 shows a graphical representation 616 of the tool.
It would have been obvious to one having ordinary skill in the art at the time of invention to display a graphical representation of the moveable portion relative to an image. One would have been motivated to display a graphical representation of the moveable portion, as taught in KANG, in order for the surgeon to better visualize the robotic arm and tools relative to the space in which the surgery is being performed. There would have been a reasonable expectation of success as KANG teaches that a graphical representation of the moveable portion may be displayed relative to an image.
Claims 6-11, 18, 19, and 21-23 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Appl. Publ. No. 2022/0125517 A1 (hereinafter “ZIMMERMANN”) and U.S. Patent No. 11,202,682 B2 (hereinafter “STAUNTON”) and in view of U.S. Patent Appl. Publ. No. 2017/0071672 A1 (hereinafter “SHOCHAT”).
Claim 6 depends from claim 1. As discussed above in the Section 102 rejection of claim 1, each and every claim limitation is taught by ZIMMERMANN.
With respect to claim 6, ZIMMERMANN does not teach the claim limitations.
However, in the same field of endeavor, STAUNTON teaches systems and methods for operating a robotic surgical system in which tool operation is modified based on a difference between a commanded state and an actual state. (Abstract). A “state” can be a position and/or orientation of the tool. (Col. 5, lines 24-27). “For example, the state may be a pose of the object, and may include linear data, and/or angular velocity data, and the like.” (Col. 6, lines 50-52). As such, STAUNTON monitors the current position and/or orientation and compares that to the position and/or orientations that were commanded.
Like ZIMMERMANN, STAUNTON also teaches using “virtual boundaries” with “haptic feedback.” (Col. 8, lines 18-35). The virtual boundaries are used “for constraining the tool 20….Such virtual boundaries 55 may also be referred to as virtual meshes, virtual constraints, or the like…The state of the tool 20 is tracked relative to the virtual boundaries 55. In one embodiment, the state of the [tool center point] TCP is measured relative to the virtual boundaries 55 for purposes of determining when and where haptic feedback force is applied to the manipulator 14, or more specifically, the tool 20.”
STAUNTON teaches that, over time, deviations between commanded and actual states can cause differences a commanded path that is based on the commanded states and an actual path that is based on the actual states. (Col. 19, lines 27-31). STAUNTON teaches making proactive changes to the path to account for future deviations. (Col. 22, lines 10-32). “Upon immediately recognizing these deviations 110, the controller 30 proactively generates the commanded tool path 100C′. This proactive updating occurs at a point in time represented by the present location of the TCP in FIG. 10. The proactively generated and updated commanded tool path 100C′ is configured to minimize deviations 110′ at a second corner (as compared to the deviations 110 from the first corner).
Notably, the proactive changes can be used to keep the tool within the virtual boundaries. For example, claim 1 of STAUNTON recites “comparing the corresponding commanded and actual states of the TCP for one or more given time steps for determining deviations between the corresponding commanded and actual states relative to the virtual boundary; and modifying one or more of a path of movement and a feed rate of the surgical tool relative to the virtual boundary to account for the deviations.” (emphasis added). The STAUNTON system is configured to “increase path or cutting accuracy at the surgical site and reduce the possibility for regenerative cutting errors.” (Col. 3, lines 10-13).
STAUNTON teaches that a “state” can be “a pose of the object” and may also include “linear data, and/or angular velocity data, and the like.” (Col. 6, lines 50-52). By comparing the commanded states and the actual states, “the controller 30, in a sense, predicts future undercuts and modifies operation of the tool 20 accordingly.” (col. 22, lines 28-30). See also claim 14 of STAUNTON: “…wherein modifying…the path of movement…comprises proactively modifying…the path of movement….” of the surgical tool along the first path to account for predicted deviations along the first path with the predicted deviations being determined based on past or present deviations along the first path.”
Accordingly, STAUNTON teaches performing at least a first portion of a procedure with the moveable portion in a first position at a first time; moving the moveable portion to a second position at a second time; and determining a path of movement of the moveable portion to the second position from the first position that does not pass through the no-go region.
It would have been obvious to one having ordinary skill in the art to, prior to moving from a first position to a second position, analyze the actual states of the moveable portion (i.e., robotic arm and/or tools), compare the actual states to the commanded states, and determine a path from the first position to the second position based on that comparison. One would have been motivated to compare the actual states to the commanded states to provide more precise control of the surgical tool and improve accuracy. (Col. 3, lines 10-13). There would have been a reasonable expectation of success because STAUNTON teaches that the system can be applied to robotic surgical systems like ZIMMERMANN’S.
However, STAUNTON does not appear to explicitly teach that the path to the second position is determined prior to moving the moveable portion to the second position. Nevertheless, STAUNTON is clearly concerned with adapting the procedure when deviations occur. (Col. 17, line 65 to col. 18, line 29).
In the same field of endeavor, SHOCHAT teaches modifying a predetermined path of a surgical tool when it is learned than an obstruction or “forbidden region” is now along the path. While SHOCHAT is primarily concerned with modifying the path of a needle, the teachings are generally applicable to surgical procedures. “[T]he methods and systems are not meant to be limited to insertion of a needle but are understood to include insertion of any tool intended to be inserted into a subject’s body for diagnostic and/or therapeutic purposes….”
SHOCHAT teaches a “preoperative image” is often used to plan a procedure. ([0002]). However, the anatomy can change after the preoperative image was acquired. “The problem is that this procedure does not take into account cyclical motion of the patient, such as from breathing, which could cause the entry point, the target point and the position of any obstacles en route to move in some sort of reproducible cycle from their initial positions relative to each other.” ([0002]). SHOCHAT teaches that despite some changes in the relative positioning of the anatomy, the plan does not have to be completely replaced but only modified to reach the target. “Alternatively, the same entry point can be maintained, but the initial orientation of the needle at the entry point can be changed in order to select an alternative initial planned trajectory which may result in a better overall trajectory for the entire procedure.” ([0009]).
In one example, the software uses the same entry point and adjusts the angle of trajectory. “[T]he software, having detected movement of the obstacle 22 and the target point 23, relative to the entry point 21 and to each other, by image processing of the actual CT images of each of these frames, recalculates the optimal trajectory 200 for each positional situation. In some implementations, the recalculation of the trajectory for each of the images may be based on the initial trajectory calculated at T=T0. For example, the software may first check if the initial calculated trajectory remains optimal given the new positional situation, or at least safe and acceptable, for the current image, and if not—insert as minimal adjustments as possible to the initial calculated trajectory.” ([0043]).
It would have been obvious to one having ordinary skill in the art to confirm that a currently planned path to the second position from the first position does not pass through a no-go region prior to moving the moveable portion to the second position. While monitoring movements of the patient and/or tool during the procedure, one would have been motivated to confirm that the predetermined plan would not move the surgical tool through a no-go region, as taught in SHOCHAT, for the safety of the patient and/or to protect the tools. There would have been a reasonable expectation of success because SHOCHAT teaches that software can analyze a current position of the tool and the patient’s anatomy to determine if the plan is still viable.
With respect to claim 7 (depending from claim 6), as discussed above with respect to claim 6, STAUNTON teaches determining the path of movement of the moveable portion to the second position from the first position that does not pass through the no-go region includes determining a first path and evaluating whether the determined first path passes through the no-go region. STAUNTON determines the first path and evaluates whether it passes through the no-go region when the controller compares the commanded and actual states of the tool. “[C]omparing the corresponding commanded and actual states of the TCP for one or more given time steps for determining deviations between the corresponding commanded and actual states relative to the virtual boundary.” (Claim 1). STAUNTON also teaches determining a second path when the first path is evaluated to pass through the no-go region. “Thus, the controller 30, in a sense, predicts future undercuts and modifies operation of the tool 20 accordingly.” (Col. 22, lines 28-30) (see also Claim 1: “modifying one or more of a path of movement and a feed rate of the surgical tool relative to the virtual boundary to account for the deviations.”).
It would have been obvious to one having ordinary skill in the art to determine a first path, evaluate whether the first path pass through the no-go region, and, if so, determine a new second path. One would have been motivated to determine whether the first path will pass through a no-go region and, if so, determine a new path in order to improve the accuracy of the surgical system. (Col. 3, lines 10-13). There would have been a reasonable expectation of success because STAUNTON teaches that the system can be applied to robotic surgical systems like ZIMMERMANN’S.
With respect to claim 8 (depending from claim 6), STAUNTON teaches outputting the determined path to control movement of the moveable portion including providing commands to drive mechanisms. The controller in STAUNTON is configured to modify the tool’s operation. “Such modification of tool 20 operation may be performed according to various techniques, but generally are focused on modifying the path of movement and/or the feed rate of the tool 20.” (Col. 8, lines 60-63). “Thus, the controller 30, in a sense, predicts future undercuts and modifies operation of the tool 20 accordingly.” (Col. 22, lines 28-30).
It would have been obvious to one having ordinary skill in the art to output the determined path to control movement of the moveable portion including providing commands to drive mechanisms. One would have been motivated to output the determined path including commands for drive mechanisms because it is necessary to communicate the determined path to the robotic system’s controller so that the new path may be carried out. There would have been a reasonable expectation of success because STAUNTON teaches that the robotic system can follow new instructions (i.e., a new path).
With respect to claim 9 (depending from claim 8), ZIMMERMANN teaches receiving an input from the user regarding the no-go region. “[i]t should be understood that a user can interact with the computer 50 at any stage during surgical planning to input information and modify any portion of the surgical plan. The surgical plan may include a plurality of planned virtual boundaries….” ([0091]).
With respect to claim 10 (depending from claim 6), STAUNTON teaches operating the robotic system to move the moveable portion to move along the determined path. “Upon immediately recognizing these deviations 110, the controller 30 proactively generates the commanded tool path 100C′….The proactively generated and updated commanded tool path 100C′ is configured to minimize deviations 110′ at a second corner (as compared to the deviations 110 from the first corner). Thus, the controller 30, in a sense, predicts future undercuts and modifies operation of the tool 20 accordingly.” (emphasis added) (Col. 22, lines 10-30).
It would have been obvious to one having ordinary skill in the art to operate the robotic system to move the moveable portion to move along the determined path. One would have been motivated to operate the robotic system to move the moveable portion to move along the determined path because, after having a new path determined, it would naturally follow that the moveable portion should be controlled to move along the new path. There would have been a reasonable expectation of success because STAUNTON teaches that the robotic system can follow new instructions (i.e., a new path).
With respect to claim 11 (depending from claim 10), STAUNTON teaches positioning an end effector of the moveable portion via the determined path. “A surgical tool 20 (hereinafter “tool”) couples to the manipulator 14 and is movable relative to the base 16 to interact with the anatomy in certain modes. The tool 20 is or forms part of an end effector 22 in certain modes.” (emphasis added) (Col. 4, lines 61-64; see also Figure 1 showing end effector 22).
It would have been obvious to one having ordinary skill in the art to position an end effector of the moveable portion via the determined path. One would have been motivated to use an end effector along the determined path as end effectors are common devices used by robotic arms. There would have been a reasonable expectation of success because STAUNTON teaches that the robotic system can use end effectors.
With respect to claim 18 (and in light of the Section 112(b) rejection), ZIMMERMANN teaches a method for determining movement of and moving at least a moveable portion of a robotic system to at least minimize contact with portions exterior to the robotic system. The surgical system is capable of tracking “the patient’s bone (i.e., tibia 10, femur 11), as well as surgical tools (e.g., pointer device, probe, cutting tool) utilized during the surgery, to allow the surgeon to visualize the bone and tools on a display 56 during the osteotomy procedure.” ([0083]). With respect to the phrase “to at least minimize contact with portions exterior to the robotic system…,” Examiner is interpreting this as a statement within the preamble that recites the purpose or intended use of the claimed invention that does not result in a manipulative difference. (see MPEP 2111.02, II: “During examination, statements in the preamble reciting the purpose or intended use of the claimed invention must be evaluated to determine whether or not the recited purpose or intended use results in a structural difference (or, in the case of process claims, manipulative difference) between the claimed invention and the prior art.” (emphasis added)). It is also noted that at least one purpose of preoperative planning is “to increase the effectiveness and efficiency of the particular procedure. In particular, preoperative planning may increase the accuracy of bone resections and implant placement while reducing the overall time of the procedure and the time the patient joint is open and exposed.” ([0003]).
ZIMMERMANN teaches positioning the robotic system relative to the subject (see, e.g., Figure 1 in which the robotic arm 60 is positioned relative to the patient); acquiring image data of a subject with an imaging system (“…prior to performance of an arthroplasty, the patient’s anatomy may be scanned using any known imaging technique, such as CT or MRI (Step 801) captured with a medical imaging machine.”([0089])); executing instructions with a processor (see, e.g., [0087]) to: reconstruct a model of the subject based at least on the acquired image data (“…the scan data is then segmented to obtain a three-dimensional representation of the patient’s anatomy. For example, prior to performance of a knee arthroplasty, a three-dimensional representation of the femur and tibia is created. Using the three-dimensional representation and as part of the planning process, femoral and tibial landmarks can be selected….” (emphasis added) ([0090])); see also [0009]: “Aspects of the present disclosure may also include an algorithm able to co-register simultaneously bone surfaces of N bones (typically forming a joint) between an ultrasound modality and a second modality (e.g. CT/MRI, or surface reconstruction employing one or more statistical/generic models morphed according to patient anatomical data)”).
ZIMMERMANN also teaches that the processor is configured to determine an external geometry of the subject based on the reconstructed model. “In certain instances, the preoperative plan may involve generating a three-dimensional (“3D”), patient specific, model of the patient bone(s) and soft tissue to undergo the joint replacement. The 3D patient model may be used as a visual aid in planning the various possibilities of implant sizes, implant orientations, implant positions, and corresponding resection planes and depths, among other parameters.” ([0005]) (see also Figure 4A showing an external geometry of the subject and [0096]: “…the navigation and haptics could be preoperatively planned to allow the system disclosed herein to cut out a bone tumor (sarcoma) or make another type of incision or resection in boney or soft tissues in performing generally any type of navigated surgery.”). ZIMMERMANN also teaches the processor is configured to define a go region relative to the determined external geometry. “Surgical registration entails mapping of virtual boundaries, determined in preoperative planning, for example, with working boundaries in physical space. A surgical robot may be permitted to perform certain actions within the virtual boundaries, such as boring a hole or resecting a bone surface.” ([0079]))).
However, ZIMMERMANN does not explicitly teach that the processor is configured to receive a second pose of the moveable portion; determine a path from a current pose of the moveable portion to the second pose that moves the moveable portion only in the go region; and outputting the determined path.
In the same field of endeavor, STAUNTON teaches receiving a second pose of the moveable portion. In STAUNTON, the system monitors actual states of the tool and compares the actual states to the commanded states. A “state” can be a position and/or orientation of the tool. (Col. 5, lines 24-27). “For example, the state may be a pose of the object, and may include linear data, and/or angular velocity data, and the like.” (Col. 6, lines 50-52). As such, STAUNTON monitors the current position and/or orientation and compares that to the position and/or orientations that were commanded. In other words, when instructions for a path are outputted to the controller, the commanded states, including positions, determine the to-be-traveled path for a tool. “The controller is configured to determine commanded states for moving the surgical tool along a first path relative to the surgical target using data from one or more of the manipulator and the navigation system.” (Col. 2, lines 2-6). Thus, in order to generate a commanded state for a tool path, the second pose of the tool along the path must be known.
STAUNTON also teaches that the processor is configured to determine a path from a current pose of the moveable portion to the second pose that moves the moveable portion only in the go region. “The state comparison module 96 determines deviations 110 between the commanded states 98 and the actual states 108. Consequently, the commanded states 98 are compared to the actual states 108 to properly account for actual states that may be different than commanded states of the tool 20 or TCP. For example, as described in the next section, the controller 30 determines tool path 100 or feed rate updates/modifications for the tool 20 based on an outcome of this comparison.” (Col. 17, lines 48-56; see also Claim 1: “[T]he one or more controllers performing the steps of:… modifying one or more of a path of movement and a feed rate of the surgical tool relative to the virtual boundary to account for the deviations.”).
STAUNTON also teaches that the processor is configured to output the determined path to move the movable portion along the determined path only in the go region. The controller in STAUNTON is configured to modify the tool’s operation. “Such modification of tool 20 operation may be performed according to various techniques, but generally are focused on modifying the path of movement and/or the feed rate of the tool 20.” (Col. 8, lines 60-63).
It would have been obvious to one having ordinary skill in the art to configure the processor to receive at least a second pose of the moveable portion, determine a path from a current pose of the moveable portion to the second pose that moves the moveable portion only in the go region, and output the determined path to move the movable portion along the determined path only in the go region. One would have been motivated to receive a second pose (i.e., commanded state to accomplish surgical step) and determine a path that moves the tool from a current pose to the second pose within the go-region (i.e., commanded states of next path to achieve the second pose) as the purpose of a robotic systems for surgery is to incrementally move a robotically-controlled tool along a path to accomplish the surgical step. There would have been a reasonable expectation of success because STAUNTON teaches that the monitoring system can be applied to robotic surgical systems like ZIMMERMANN’S.
With respect to claim 19, as discussed above with respect to claim 18, ZIMMERMANN as modified by STAUNTON, teaches determining a path from a current pose of the moveable portion to the second pose that moves the moveable portion only in the go region. As such, ZIMMERMANN as modified by STAUNTON teaches determining a first path.
STAUNTON also teaches evaluating whether the determined first path passes through only the go region and determining a second path when the first path is evaluated to pass through a region other than the go region. As explained above, STAUNTON controls the surgical tool by monitoring actual states of the tool and comparing them to commanded states. “[C]omparing the corresponding commanded and actual states of the TCP for one or more given time steps for determining deviations between the corresponding commanded and actual states relative to the virtual boundary.” (Claim 1). If a significant deviation exists, STAUNTON determines that the current path has deviated (i.e., is either currently positioned beyond the virtual boundary or will clear the virtual boundary) and generates a new path. “[M]odifying one or more of a path of movement and a feed rate of the surgical tool relative to the virtual boundary to account for the deviations.” (Id).
It would have been obvious to one having ordinary skill in the art to configure the processor to evaluate whether the determined first path passes through only the go region and determine a second path when the first path is evaluated to pass through a region other than the go region. One would have been motivated to compare the actual states to the commanded states (i.e., evaluate the first path) and determine a new path if a significant deviation exists to provide more precise control of the surgical tool and improve accuracy. (Col. 3, lines 10-13).. There would have been a reasonable expectation of success because STAUNTON teaches that the monitoring system can be applied to robotic surgical systems like ZIMMERMANN’S.
With respect to claim 21 (depending from claim 7), STAUNTON teaches outputting the second path to control movement of the moveable portion without passing through the no-go region. The controller in STAUNTON is configured to modify the tool’s operation. “Such modification of tool 20 operation may be performed according to various techniques, but generally are focused on modifying the path of movement and/or the feed rate of the tool 20.” (Col. 8, lines 60-63).
However, STAUNTON does not appear to explicitly teach determining the second path prior to moving the moveable portion. Nevertheless, STAUNTON is clearly concerned with adapting the procedure when deviations occur. (Col. 17, line 65 to col. 18, line 29).
In the same field of endeavor, SHOCHAT teaches modifying a predetermined path of a surgical tool when it is learned than an obstruction or “forbidden region” is now along the path. While SHOCHAT is primarily concerned with modifying the path of a needle, the teachings are generally applicable to surgical procedures. “[T]he methods and systems are not meant to be limited to insertion of a needle but are understood to include insertion of any tool intended to be inserted into a subject’s body for diagnostic and/or therapeutic purposes….”
SHOCHAT teaches a “preoperative image” is often used to plan a procedure. ([0002]). However, the anatomy can change after the preoperative image was acquired. “The problem is that this procedure does not take into account cyclical motion of the patient, such as from breathing, which could cause the entry point, the target point and the position of any obstacles en route to move in some sort of reproducible cycle from their initial positions relative to each other.” ([0002]). SHOCHAT teaches that despite some changes in the relative positioning of the anatomy, the plan does not have to be completely replaced but only modified to reach the target. “Alternatively, the same entry point can be maintained, but the initial orientation of the needle at the entry point can be changed in order to select an alternative initial planned trajectory which may result in a better overall trajectory for the entire procedure.” ([0009]).
In one example, the software uses the same entry point and adjusts the angle of trajectory. “[T]he software, having detected movement of the obstacle 22 and the target point 23, relative to the entry point 21 and to each other, by image processing of the actual CT images of each of these frames, recalculates the optimal trajectory 200 for each positional situation. In some implementations, the recalculation of the trajectory for each of the images may be based on the initial trajectory calculated at T=T0. For example, the software may first check if the initial calculated trajectory remains optimal given the new positional situation, or at least safe and acceptable, for the current image, and if not—insert as minimal adjustments as possible to the initial calculated trajectory.” ([0043]).
It would have been obvious to one having ordinary skill in the art to confirm that a currently planned path to the second position from the first position does not pass through a no-go region and, if it does, determine a second path prior to moving the moveable portion that does not pass through a no-go region. While monitoring movements of the patient and/or tool during the procedure, one would have been motivated to confirm, prior to moving the surgical tool, that the predetermined plan would not move the surgical tool through a no-go region, as taught in SHOCHAT, for the safety of the patient and/or to protect the tools. There would have been a reasonable expectation of success because SHOCHAT teaches that software can analyze a current position of the tool and the patient’s anatomy to determine if the plan is still viable.
With respect to claim 22 (depending from claim 13), ZIMMERMANN does not teach the claim limitations of claim 22. More specifically, ZIMMERMANN does not teach a processor configured to determine a first path between the pose and a second pose of the moveable portion relative to the defined no-go region, evaluate whether the first path passes through the no-go region, determine a second path, prior to moving the moveable portion, when the first path is evaluated to pass through the no-go region; and output the second path to control movement of the moveable portion without passing through the no-go region.
STAUNTON teaches determining a first path and evaluating whether the determined first path passes through the no-go region. STAUNTON determines the first path and evaluates whether it passes through the no-go region when the controller compares the commanded and actual states of the tool. As explained above, STAUNTON controls the surgical tool by monitoring actual states of the tool and comparing them to commanded states. “[C]omparing the corresponding commanded and actual states of the TCP for one or more given time steps for determining deviations between the corresponding commanded and actual states relative to the virtual boundary.” (Claim 1). If a significant deviation exists, STAUNTON determines that the current path has deviated (i.e., is either currently positioned beyond the virtual boundary or will clear the virtual boundary) and generates a new path. “[M]odifying one or more of a path of movement and a feed rate of the surgical tool relative to the virtual boundary to account for the deviations.” (Id). STAUNTON also teaches determining a second path when the first path is evaluated to pass through the no-go region. “Thus, the controller 30, in a sense, predicts future undercuts and modifies operation of the tool 20 accordingly.” (Col. 22, lines 28-30) (see also Claim 1: “modifying one or more of a path of movement and a feed rate of the surgical tool relative to the virtual boundary to account for the deviations.”). STAUNTON also teaches outputting the second path to control movement of the moveable portion without passing through the no-go region. The controller in STAUNTON is configured to modify the tool’s operation. “Such modification of tool 20 operation may be performed according to various techniques, but generally are focused on modifying the path of movement and/or the feed rate of the tool 20.” (Col. 8, lines 60-63).
It would have been obvious to one having ordinary skill in the art to determine a first path, evaluate whether the first path pass through the no-go region, and, if so, determine a new second path and then output the second path for moving the tool. One would have been motivated to determine whether the first path will pass through a no-go region and, if so, determine a new path in order to improve the accuracy of the surgical system. (Col. 3, lines 10-13). More specifically, one would have been motivated to compare the actual states to the commanded states (i.e., evaluate the first path) and determine a new path if a significant deviation exists to provide more precise control of the surgical tool and improve accuracy. (Col. 3, lines 10-13).. There would have been a reasonable expectation of success because STAUNTON teaches that the monitoring system can be applied to robotic surgical systems like ZIMMERMANN’S.
However, STAUNTON does not appear to explicitly teach determining the second path prior to moving the moveable portion. Nevertheless, STAUNTON is clearly concerned with adapting the procedure when deviations occur. (Col. 17, line 65 to col. 18, line 29).
In the same field of endeavor, SHOCHAT teaches modifying a predetermined path of a surgical tool when it is learned than an obstruction or “forbidden region” is now along the path. While SHOCHAT is primarily concerned with modifying the path of a needle, the teachings are generally applicable to surgical procedures. “[T]he methods and systems are not meant to be limited to insertion of a needle but are understood to include insertion of any tool intended to be inserted into a subject’s body for diagnostic and/or therapeutic purposes….”
SHOCHAT teaches a “preoperative image” is often used to plan a procedure. ([0002]). However, the anatomy can change after the preoperative image was acquired. “The problem is that this procedure does not take into account cyclical motion of the patient, such as from breathing, which could cause the entry point, the target point and the position of any obstacles en route to move in some sort of reproducible cycle from their initial positions relative to each other.” ([0002]). SHOCHAT teaches that despite some changes in the relative positioning of the anatomy, the plan does not have to be completely replaced but only modified to reach the target. “Alternatively, the same entry point can be maintained, but the initial orientation of the needle at the entry point can be changed in order to select an alternative initial planned trajectory which may result in a better overall trajectory for the entire procedure.” ([0009]).
In one example, the software uses the same entry point and adjusts the angle of trajectory. “[T]he software, having detected movement of the obstacle 22 and the target point 23, relative to the entry point 21 and to each other, by image processing of the actual CT images of each of these frames, recalculates the optimal trajectory 200 for each positional situation. In some implementations, the recalculation of the trajectory for each of the images may be based on the initial trajectory calculated at T=T0. For example, the software may first check if the initial calculated trajectory remains optimal given the new positional situation, or at least safe and acceptable, for the current image, and if not—insert as minimal adjustments as possible to the initial calculated trajectory.” ([0043]).
It would have been obvious to one having ordinary skill in the art to confirm that a currently planned path to the second position from the first position does not pass through a no-go region and, if it does, determine a second path prior to moving the moveable portion that does not pass through a no-go region. While monitoring movements of the patient and/or tool during the procedure, one would have been motivated to confirm, prior to moving the surgical tool, that the predetermined plan would not move the surgical tool through a no-go region, as taught in SHOCHAT, for the safety of the patient and/or to protect the tools. There would have been a reasonable expectation of success because SHOCHAT teaches that software can analyze a current position of the tool and the patient’s anatomy to determine if the plan is still viable.
With respect to claim 23 (depending from claim 19), STAUNTON teaches outputting the second path to control movement of the moveable portion only in the go region. The controller in STAUNTON is configured to modify the tool’s operation. “Such modification of tool 20 operation may be performed according to various techniques, but generally are focused on modifying the path of movement and/or the feed rate of the tool 20.” (Col. 8, lines 60-63).
However, STAUNTON does not appear to explicitly teach determining the second path prior to moving the moveable portion. Nevertheless, STAUNTON is clearly concerned with adapting the procedure when deviations occur. (Col. 17, line 65 to col. 18, line 29).
In the same field of endeavor, SHOCHAT teaches modifying a predetermined path of a surgical tool when it is learned than an obstruction or “forbidden region” is now along the path. While SHOCHAT is primarily concerned with modifying the path of a needle, the teachings are generally applicable to surgical procedures. “[T]he methods and systems are not meant to be limited to insertion of a needle but are understood to include insertion of any tool intended to be inserted into a subject’s body for diagnostic and/or therapeutic purposes….”
SHOCHAT teaches a “preoperative image” is often used to plan a procedure. ([0002]). However, the anatomy can change after the preoperative image was acquired. “The problem is that this procedure does not take into account cyclical motion of the patient, such as from breathing, which could cause the entry point, the target point and the position of any obstacles en route to move in some sort of reproducible cycle from their initial positions relative to each other.” ([0002]). SHOCHAT teaches that despite some changes in the relative positioning of the anatomy, the plan does not have to be completely replaced but only modified to reach the target. “Alternatively, the same entry point can be maintained, but the initial orientation of the needle at the entry point can be changed in order to select an alternative initial planned trajectory which may result in a better overall trajectory for the entire procedure.” ([0009]).
In one example, the software uses the same entry point and adjusts the angle of trajectory. “[T]he software, having detected movement of the obstacle 22 and the target point 23, relative to the entry point 21 and to each other, by image processing of the actual CT images of each of these frames, recalculates the optimal trajectory 200 for each positional situation. In some implementations, the recalculation of the trajectory for each of the images may be based on the initial trajectory calculated at T=T0. For example, the software may first check if the initial calculated trajectory remains optimal given the new positional situation, or at least safe and acceptable, for the current image, and if not—insert as minimal adjustments as possible to the initial calculated trajectory.” ([0043]).
It would have been obvious to one having ordinary skill in the art to confirm that a currently planned path to the second position from the first position does not pass through a no-go region and, if it does, determine a second path prior to moving the moveable portion that does not pass through a no-go region. While monitoring movements of the patient and/or tool during the procedure, one would have been motivated to confirm, prior to moving the surgical tool, that the predetermined plan would not move the surgical tool through a no-go region, as taught in SHOCHAT, for the safety of the patient and/or to protect the tools. There would have been a reasonable expectation of success because SHOCHAT teaches that software can analyze a current position of the tool and the patient’s anatomy to determine if the plan is still viable.
Claims 14 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Appl. Publ. No. 2022/0125517 A1 (hereinafter “ZIMMERMANN”) and O’Connor TE, O’Hehir MM, Khan A, Mao JZ, Levy LC, Mullin JP, Pollina J. Mazor X stealth robotic technology: a technical note. World neurosurgery. 2021 Jan 1;145:435-42. (hereinafter “MAZOR”).
Claim 14 depends from claim 13. As discussed above in the Section 102 rejection of claim 13, each and every claim limitation is taught by ZIMMERMANN.
With respect to claim 14, ZIMMERMANN does not teach that a first portion the robotic system configured to be fixed relative to the subject.
In the same field of endeavor, MAZOR teaches that “[s]everal methods exist for attaching the robot to the patient. These methods include a single posterior superior iliac spine (PSIS) Schanz screw (Figure 4), bilateral PSIS Schanz screws (Figure 5), a spinous process clamp, or multiple spinous process headpins with a link bridge that can be used for percutaneous procedures. Bilateral Schanz screws should be used to secure the robot when placing instrumentation above L3. The bone mount bridge is securely connected to the attachment point on the patient, thus connecting the robot arm to the patient.” (p.436, left column, Robotic Technique). Figure 4 of MAZOR shows “[a] single posterior superior iliac spine Schanz screw can be used to secure the robot to the patient.” (p.437, Figure 4 caption).
It would have been obvious to one having ordinary skill in the art to design the system so that the robotic system is configured to be fixed relative to the subject. One would have been motivated to incorporate this feature because securing the robotic system relative to the patient (e.g., using a Schanz screw) facilitates registering the patient’s anatomy to the robotic system while also maintaining that fixed relationship if the patient moves. There would have been a reasonable expectation of success as MAZOR teaches that a robotic system, similar to ZIMMERMANN’s, can be fixed relative to the subject.
With respect to claim 15, ZIMMERMANN teaches that a second portion of the robotic system is configured to be tracked by the tracking system to determine the pose of the moveable portion. “The navigation system 42, which tracks the movements of the robotic arm 60 via various tracker arrays (e.g., 48, 54).” ([0137]). Tracker array 54 is attached to the arm and/or tool and tracker array 48 is attached to the base of the device 60. (See Figure 1).
RESPONSE TO APPLICANT’S ARGUMENTS
Applicant argues that ZIMMERMANN does not disclose determining a volume defined by a subject of a generated model and defining a no-go region relative to the determine volume. “As noted, the cited portions of Zimmermann disclose mapping virtual boundaries with working boundaries in a physical space and performing certain actions within the virtual boundaries with a surgical robot. See Zimmermann, paras. [0079], [0085], [0090], and [0107J-[0109]. However, mapping virtual boundaries in a physical space is not the same as determining a volume of a generated model, defining a no-go region relative to the determined volume, and moving a moveable portion without passing through the no-go region as generally recited in amended independent claim 1.” (Page 13 of Response).
Examiner disagrees. First, ZIMMERMANN is not mapping virtual boundaries in a physical space but to the physical space. “Registration involves mapping of the virtual boundaries and constraints as defined in the preoperative plan to the patient in physical space so the robotic system can be accurately tracked relative to the patient and constrained relative to the boundaries as applied to the patient’s anatomy.” ([0006])
Second, determining the volume of the model occurs during preoperative planning. The volume is based on 3D image data. “In certain instances, the preoperative plan may involve generating a three-dimensional (“3D”), patient specific, model of the patient bone(s) and soft tissue to undergo the joint replacement.” ([0005]). A 3D image represents a volume and making a preoperative plan for surgery within that volume necessarily “determines a [sub-]volume of a generated model.”
Third, ZIMMERMANN clearly teaches defining a no-go region relative to the determined volume. “The 3D patient model may be used as a visual aid in planning the various possibilities of implant sizes, implant orientations, implant positions, and corresponding resection planes and depths, among other parameters.” ([0005]). “Registration involves mapping of the virtual boundaries and constraints as defined in the preoperative plan to the patient in physical space so the robotic system can be accurately tracked relative to the patient and constrained relative to the boundaries as applied to the patient’s anatomy.” ([0006]).
Finally, ZIMMERMANN clearly teaches moving the movable portion without passing the no-go region. “Once the virtual boundaries are mapped to the physical space of the patient, the robot may bore the hole or resect the bone surface in a location and orientation as planned, but may be constrained from performing such actions outside the pre-planned virtual boundaries.” ([0079]).
Prior Art Made of Record
The prior art made of record and not relied upon is considered pertinent to applicant’s disclosure.
US 2021/0343397 A1 teaches a surgical planning system that evaluates multiple candidate trajectories (i.e., plans) and ranks them according to defined parameters, including a distance from “critical no-go location.”
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/JASON P GROSS/Examiner, Art Unit 3797
/SERKAN AKAR/Primary Examiner, Art Unit 3797
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