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 .
Acknowledgement of Amendment
The following office action is in response to the applicant’s amendment filed on 11/05/2025. Claims 1-18 are pending. Claims 1, 4, 10 and 13-18 have been amended. Claims 1-18 are rejected under 35 U.S.C. 103 for the reasons stated in the Response to Arguments and 35 U.S.C. 103 sections below.
Response to Arguments
Applicant’s arguments, see Remarks page 9-11, filed 11/05/2025, with respect to the objections to the drawings, specification and claims have been fully considered and are persuasive given the amendments made thereto. The objections to the drawings, specification and claims in the non-final rejection of 08/05/2025 have been withdrawn.
Applicant’s arguments, see Remarks page 11, filed 11/05/2025, with respect to the rejection of claims 1-18 under 35 U.S.C. 112(a)/112(b) have been fully considered and are persuasive.
Regarding claims 1 and 10, these claims were rejected under 35 U.S.C. 112(a) because, according to the examiner, there is a lack of written description for the term “working piece” in the limitation “a working piece attached to the shaft and extending radially outwardly from the shaft” (Claim 1) and “a working piece attached to the distal portion of the shaft and extending radially outwardly from the shaft” (Claim 10). Additionally, these claims were also rejected under 35 U.S.C. 112(b) because it was unclear what the “working piece” was referring to. Accordingly, claims 1 and 10 have been amended to remove the above limitations related to the working piece.
Therefore, the rejections of claims 1 and 10, along with their corresponding dependent claims (i.e. claims 2-9 and 11-18, respectively under 35 U.S.C. 112(a)/112(b) in the non-final rejection of 08/05/2025 have been withdrawn.
Applicant’s arguments, see Remarks page 11-13, filed 11/05/2025, with respect to the rejection of claims 1-18 under 35 U.S.C. 101 have been fully considered and are persuasive.
Regarding claims 1 and 10, these claims are directed to “a method for determining an orientation of an instrument in a navigated surgical procedure”. The Applicant argues that since the method is employed in a navigated surgical procedure, the claims are directed to the functioning of a computer, or an improvement to other technology or technical field.
In the Action, the Examiner alleges that the claims are "directed to a judicial exception in the form of an abstract idea, specifically a mental process, without significantly more." (Action, p. 6.) However, the Applicant argues that this is incorrect.
The Applicant argues that the rejection should be withdrawn because, even if the claims are directed to a judicial exception, they adequately integrate the judicial exception into a practical application because the claims are directed to "[a]n improvement in the functioning of a computer, or an improvement to other technology or technical field." (MPEP § 2106.04(d)(I).)
Applicant does not agree that claim 1 is directed to patent ineligible subject matter. However, even if it is, the claim, as a whole, is directed to a navigated surgical procedure, and thus, includes ""[a]n improvement in the functioning of a computer, or an improvement to other technology or technical field." Per the MPEP, "examiners should evaluate whether the claim as a whole integrates the recited judicial exception into a practical application of the exception in Step 2A Prong Two. 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).) Further, "A claim reciting a judicial exception is not directed to the judicial exception if it also recites additional elements demonstrating that the claim as a whole integrates the exception into a practical application. One way to demonstrate such integration is when the claimed invention improves the functioning of a computer or improves another technology or technical field. The application or use of the judicial exception in this manner meaningfully limits the claim by going beyond generally linking the use of the judicial exception to a particular technological environment, and thus transforms a claim into patent-eligible subject matter. Such claims are eligible at Step 2A because they are not "directed to" the recited judicial exception." (MPEP § 2106.04(d)(1)).) Accordingly, because the claims, as a whole, "improve[] the functioning of a computer or improves another technology or technical field," any alleged judicial exception is adequately integrated into a practical application, and thus the claims are directed to patent eligible subject matter.
The examiner respectfully acknowledges that even if the claims are directed to a judicial exception, they adequately integrate the judicial exception into a practical application because the claims are directed to "[a]n improvement in the functioning of a computer, or an improvement to other technology or technical field." (MPEP § 2106.04(d)(I). The examiner agrees that even if a judicial exception did exist, that the claim, as a whole, is directed to a navigated surgical procedure, and thus, includes "[a]n improvement in the functioning of a computer, or an improvement to other technology or technical field". Furthermore, the examiner acknowledges that because the claims, as a whole, "improve[] the functioning of a computer or improves another technology or technical field," any alleged judicial exception is adequately integrated into a practical application, and thus the claims are directed to patent eligible subject matter.
Therefore, the rejection of claims 1-18 under 35 U.S.C. 101 in the non-final rejection of 08/05/2025 has been withdrawn.
Applicant’s arguments, see Remarks page 13-15, filed 11/05/2025, with respect to the rejection of claims 1-18 under 35 U.S.C. 101 have been fully considered and are not persuasive.
Regarding claims 1 and 10, in the action, the Examiner cites to Crawford as teaching a method of determining an orientation of an instrument in a navigated surgical procedure, providing an instrument having a shaft, a tracking array attached to the shaft, a surveillance marker coupled to the instrument and trackable by the tracking device, and determining a circumferential position of the tracking array. (Action, p. 10-12.).
However, the Examiner admits that Crawford fails to teach or suggest a tracking array that is "rotatably attached" to the shaft. (Id. at 13.). For this feature, the Examiner relies on Burger, and reasons that "[i]t would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the tracking array of Crawford such that the tracking array is rotatably attached to the proximal portion of the shaft for rotation about the central axis as disclosed in Burger in order to allow for optimal positioning of the tracking array prior to performing a procedure." (Id. at 14.).
However, the Applicant argues that this is incorrect, particularly in light of the amended claims.
The applicant argues that the rejection should be withdrawn because Crawford, alone and in combination with Burger, fails to teach or suggest "determining a circumferential position of the tracking array relative to the shaft based on the position of the surveillance marker" as now claimed.
Crawford teaches that "[t]he system further includes at least one camera able to detect the plurality of fixed tracking markers and the moveable tracking marker on the instrument, wherein the robot determines a position or movement of the moveable tracking marker to determine a variable of the implant." [0011]. Thus, the system of Crawford can determine a position of the tracking marker of the instrument relative to an implant. This is not the same as "determining a circumferential position of the tracking array relative to the shaft based on the position of the surveillance marker" as required by the claim. Accordingly, Crawford fails to teach or suggest "determining a circumferential position of the tracking array relative to the shaft based on the position of the surveillance marker" as now recited in claim 1.
Burger fails to cure the deficiencies of Crawford and is not cited as teaching this feature.
Because Crawford, alone and in combination with Burger, fails to teach or suggest
"determining a circumferential position of the tracking array relative to the shaft based on the position of the surveillance marker" as now recited in claim 1, the Applicant argues that the rejection of claim 1 should be withdrawn. Furthermore, the Applicant argues that the rejection of claim 10 should also be withdrawn, at least because it recites similar features. Finally, the Applicant argues that the rejection of claims 2-9 and 11-18 should also be withdrawn, at least because they depend from claim 1 or 10.
The examiner respectfully disagrees with the Applicant’s argument that Crawford does not teach “determining a circumferential position of the tracking array relative to the shaft based on the position of the surveillance marker”.
The examiner respectfully notes that the tracking array 612 (see Crawford: FIGS. 17A, 17B, 18A, 18B) is positioned relative to the shaft 622 (i.e. at the proximal end thereof). The tracking array 612 contains fixed markers 804 and one or more moveable markers 806, the moveable marker(s) 806 representing the surveillance marker.
As shown in FIGS. 17A-18B, the surveillance marker 806 is “capable of moving within a pre-determined boundary (e.g., sliding, rotating, etc.) relative to the fixed markers 804” [0127], this pre-determined boundary being along the shaft 622.
Since the system includes a includes at least one camera able to detect the plurality of fixed tracking markers (i.e. 804) and the moveable tracking marker (i.e. 806) on the instrument (See [0011]), the method carried out by the at least one camera performs the step of determining a circumferential position of the tracking array (i.e. tracking array 612 includes fixed tracking markers 804, moveable tracking marker(s) 806) relative to the shaft (i.e. 622) based on the position of the surveillance marker (i.e. 806).
The examiner referenced Burger to teach that the tracking array is rotatably attached to the shaft (see Burger: [0050]). The examiner respectfully asserts that the modifying the tracking array 612 (i.e. containing the fixed markers 804 and the movable marker 806 i.e. surveillance marker) of Crawford such that it is rotatably attached to the shaft as disclosed in Burger would allow for the tracking array to be optimally positioned prior to performing a procedure. Furthermore, even if the tracking array 612 of Crawford is rotated to a different circumferential position around the shaft (i.e. after being modified according to the teachings of Burger), the at least one camera of Crawford (see [0011]) would still be able to take an image of the scene in which the tracking array 612 is located, and therefore determine its circumferential position based on the position of the surveillance marker (i.e. 806 included within the tracking array 612).
Therefore, the examiner respectfully maintains that the combination of Crawford and Burger teaches “determining a circumferential position of the tracking array relative to the shaft based on the position of the surveillance marker and the tracking array as received from the tracking device” (Claim 1) and “determining a circumferential position of the tracking array relative to the shaft and the central axis based on the position of the surveillance marker and the tracking array as received from the tracking device” (Claim 10) for the reasons stated above.
Regarding claims 2-9 and 11-18, due to their dependence on claims 1 or 10, respectively, these claims are subject to the reasoning provided therein. Thus, the rejection of claims 2-9 and 11-18 under 35 U.S.C. 103 for the reasons stated in the Response to Arguments section above and the 35 U.S.C. 103 below.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1-5, 7-8, and 10-17 is/are rejected under 35 U.S.C. 103 as being unpatentable by Crawford et al. US 2016/0256225 A1 “Crawford” and further in view of Burger US 2009/0099445 A1 “Burger”.
Regarding claims 1 and 10, Crawford teaches “A method of determining an orientation of an instrument in a navigated surgical procedure, the method comprising:” (Claims 1 and 10) (“To meet this and other needs, devices, systems, and methods for determining the 3-dimensional position of an object for use with robot-assisted surgeries is provided” [0007]; “FIG. 16 is a block diagram of a method 1100 for navigating and moving the end-effector 1012 (or any other end-effector described herein) of the robot 102 to a desired target trajectory” [0117]; “This method 1100 has advantages over a method in which the continuous monitoring of the single marker 1018 to verify the location is omitted” [0122]. Therefore, Crawford provides a method of determining an orientation of an instrument (i.e. object) in a navigated surgical procedure.);
“providing an instrument including: a shaft defining a central axis” (Claim 1); “providing an instrument including: a shaft defining a central axis and having a proximal portion and a distal portion” (Claim 10) (“Turning now to FIGS. 17A-17B and 18A-18B, instruments 608, such as implant holders 608B, 608C, are depicted which include both fixed and moveable tracking markers 804, 806. The implant holders 608B, 608C may have a handle 620 and an outer shaft 622 extending from the handle 620. The shaft 622 may be positioned substantially perpendicular to the handle 620, as shown, or in any other suitable orientation. An inner shaft 626 may extend through the outer shaft 622 with a knob 628 at one end. Implant 10, 12 connects to the shaft 622, at the other end, at tip 624 of the implant holder 608B, 608C using typical connection mechanisms known to those of skill in the art. The knob 628 may be rotated, for example, to expand or articulate the implant 10, 12” [0126]. In this case, the instruments 608, shown in FIGS. 17A-17B and 18A-18B represent navigated instruments which include a shaft (i.e. outer shaft 622 in combination with the inner shaft 626) defining a central axis. As shown in FIGS. 17A-17B and 18A-18B, the shaft has a proximal portion (i.e. to which the tracking array 612 connects) and a distal portion (i.e. to which the implant 10, 12 connects).);
“a tracking array […] attached to the shaft […] and including a plurality of tracking markers trackable by a tracking device” (Claim 1); “a tracking array […] attached to the proximal portion of the shaft […] and including a plurality of tracking markers trackable by a tracking device” (Claim 10) (“When tracking the tool 608, such as implant holder 608B, 608C, the tracking array 612 may contain a combination of fixed markers 804 and one or more moveable markers 806 which make up the array 612 or is otherwise attached to the implant holder 608B, 608C. […] In addition, at least one marker 806 is present which can be attached to the array 612 or the instrument itself which is capable of moving within a pre-determined boundary (e.g., sliding, rotating, etc.) relative to the fixed markers 804” [0127]. Since the instrument 608 (i.e. navigated instrument) contains a tracking array (i.e. 612) with markers 804 (as shown in FIGS. 15B, 17A-17B, and 18A-18B), the instrument includes a tracking array (i.e. 612) attached to the proximal portion of the shaft (i.e. 622) and including a plurality of tracking markers (i.e. 804) trackable by a tracking device (i.e. camera, see [0008]: “According to one embodiment, a surgical robot system includes a robot having a robot base and a display, a robot arm coupled to the robot base, and an end-effector coupled to the robot arm, the end-effector having one or more tracking markers. […] The system further includes a camera stand including at least one camera able to detect the one or more tracking markers, wherein the robot determines a 3-dimensional position of the one or more tracking markers”).
“a surveillance marker coupled to the instrument and trackable by the tracking device” (Claim 1); “a rotatable and translatable surveillance marker coupled to the proximal portion of the instrument and trackable by the tracking device” (Claim 10) (See [0127] as discussed above. In this case, since the marker 806 is attached to the array 612 or the instrument itself and is capable of moving within a pre-determined boundary (i.e. sliding, rotating, etc.), the marker 806 represents a rotatable and translatable surveillance marker coupled to the proximal portion of the instrument and trackable by the tracking device (i.e. camera, see [0008] above.).).; and
“determining a circumferential position of the tracking array relative to the shaft based on the position of the surveillance marker and the tracking array as received from the tracking device” (Claim 1); “determining a circumferential position of the tracking array relative to the shaft and the central axis based on the position of the surveillance marker and the tracking array as received from the tracking device” (Claim 10) (“The system further includes at least one camera able to detect the plurality of fixed tracking markers and the moveable tracking marker on the instrument, wherein the robot determines a position or movement of the moveable tracking marker to determine a variable of the implant” [0011]. Therefore, since the at least on camera detects the plurality of fixed tracking markers (i.e. 804 in FIGS. 17A-17B and 18A-18B) and the moveable tracking marker (i.e. 806 in FIGS. 17A-17B, and 18A-18B), the moveable tracking marker(s) 806 moving along a pre-determined boundary relative to the fixed markers 804 and the shaft 622 (see [0127]), the method carried out by the system involves determining a circumferential position of the tracking array (i.e. 612) relative to the shaft (i.e. 622) and the central axis based on the position of the surveillance marker (i.e. 806) and the tracking array (i.e. 612) as received from the tracking device (i.e. camera, see [0008]).).
Although Crawford discloses “As shown in FIG. 15B, when a snugly fitting tool or instrument 608 is placed within the guide tube 1014, the instrument 608 becomes mechanically constrained in 4 or 6 degrees of freedom. That is, the instrument cannot be rotated in any direction except about the longitudinal axis 1016 of the guide tube 1014 and the instrument 608 cannot be translated in any direction except along the longitudinal axis 1016 of the guide tube 1014. In other words, the instrument 608 can only be translated along and rotated about the centerline of the guide tube 1014” [0110] (i.e. the instrument 608 containing the tracking array 612 rotates within the guide tube 1014 along the longitudinal axis 1016, not the tracking array 612 by itself), Crawford does not teach that the tracking array is “rotatably attached” to the shaft or the proximal portion of the shaft “for rotation about the central axis” (Claims 1 and 10).
Burger teaches that the tracking array is “rotatably attached” to the shaft or the proximal portion of the shaft “for rotation about the central axis” (Claims 1 and 10) (“As illustrated in FIG. 1C by arrow 172 marker assembly 162 can be rotated around the longitudinal axis of the instrument and can also be translated along the longitudinal axis and then clamped in place, so as to optimally position the marker array for tracking” [0050]. Therefore, the tracking array (i.e. marker assembly 162) is rotatably attached to the proximal portion of the shaft for rotation about the central axis.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the tracking array of Crawford such that the tracking array is rotatably attached to the proximal portion of the shaft for rotation about the central axis as disclosed in Burger in order to allow for optimal positioning of the tracking array prior to performing a procedure (see Burger: [0050]). Rotating a tracking array around the longitudinal axis of an instrument and clamping it in place once optimally positioned is one of a finite number of techniques which can be used when tracking a surgical tool with a reasonable expectation of success. Thus, modifying the tracking array of Crawford such that is it rotatably attached to the proximal portion of the shaft for rotation about the central axis as disclosed in Burger would yield the predictable result of optimally positioning and clamping the tracking array such that tracking can be performed during the surgical procedure.
Regarding claims 2 and 11, Crawford in view of Burger discloses all features of the claimed invention as discussed with respect to claims 1 and 10 above, and Crawford further teaches “wherein determining a circumferential position of the tracking array includes determining 3D coordinates of the tracking markers” (Claims 2 and 11) (See [0007] as discussed with respect to claims 1 and 10 above, and “To enable automatic tracking of one or more tools 608, end-effector 112, or other object to be tracked in 3D (e.g., multiple rigid bodies), the markers 118, 804 on each tool 608, end-effector 112, or the like, are arranged asymmetrically with a known inter-marker spacing” [0092]. Thus, since the tools 608 are automatically tracked in 3D based on the location of the markers 804 (i.e. arranged asymmetrically with known inter-marker spacing), the method carried out by the system involves determining 3D coordinates of the tracking markers (i.e. 804). Therefore, the step of determining a circumferential position of the tracking array includes determining 3D coordinates of the tracking markers.).
Regarding claims 3 and 12, Crawford in view of Burger discloses all features of the claimed invention as discussed with respect to claims 2 and 11 above, and Crawford further teaches “wherein the plurality of tracking markers are optical markers trackable by cameras of the tracking device through stereophotogrammetry” (Claims 3 and 12) (“Tracking markers 804 may be of any type described herein including but not limited to light emitting diodes or reflective spheres” [0069]; “At steps 1514 and 1516, the navigation space may be overlaid on the image space and objects with markers visible in the navigation space (for example, surgical instrument with optical markers 804)” [0086]; “Stereophotogrammetric tracking of these four markers 804 allows the instrument 608 to be tracked as a rigid body and for the tracking system 100, 300, 600 to precisely determine the position of the tip 624 and the orientation of the shaft 622 while the probe 608A is moved around in front of tracking cameras 200, 326” [0091]. Therefore, the plurality of tracking markers (i.e. markers 804) are optical markers (see [0086]) trackable by cameras (i.e. tracking cameras 200, 326) of the tracking device through stereophotogrammetry (i.e. see [0091]).
Regarding claims 4 and 13, Crawford in view of Burger discloses all features of the claimed invention as discussed with respect to claims 1 and 10 above, and Burger further teaches “wherein the tracking array is configured to be rotated 360 degrees about the central axis of the instrument” (See [0050] as discussed with respect to claims 1 and 10 above and “For example if there are N different positions at which the marker array can be attached to the instrument, then there should be N different degrees of rotation possible for the marker array. […] In one embodiment this is achieved by pivotally mounting the marker array so that it can rotate about its support and providing indexation points every 360'' divided by N to provide N different rotational positions for the marker array” [0071]. Therefore, the tracking array (i.e. marker array) is configured to [be] rotated 360 degrees about the central axis of the instrument.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the tracking array of Crawford such that the tracking array is rotatably attached to the proximal portion of the shaft for rotation about the central axis and is configured to be rotated 360 degrees with respect to the central axis of the instrument as disclosed in Burger in order to allow for optimal positioning of the tracking array prior to performing a procedure (see Burger: [0050]). Rotating a tracking array 360° around the longitudinal axis of an instrument and clamping it in place once optimally positioned is one of a finite number of techniques which can be used when tracking a surgical tool with a reasonable expectation of success. Thus, modifying the tracking array of Crawford such that is it rotatably attached to the proximal portion of the shaft for rotation about the central axis and is configured to be rotated 360 degrees with respect to the central axis of the instrument as disclosed in Burger would yield the predictable result of optimally positioning and clamping the tracking array such that tracking can be performed during the surgical procedure.
Regarding claims 5 and 14, Crawford in view of Burger discloses all features of the claimed invention as discussed with respect to claims 1 and 10 above, and Crawford further teaches “wherein the surveillance marker includes a plurality of surveillance markers positioned apart from the tracking array” (Claim 5); “wherein the surveillance marker includes a plurality of surveillance markers trackable by the tracking device” (Claim 14); (“When tracking the tool 608, such as implant holder 608B, 608C, the tracking array 612 may contain a combination of fixed markers 804 and one or more moveable markers 806 which make up the array 612 or is otherwise attached to the implant holder 608B, 608C. […] In addition, at least one marker 806 is present which can be attached to the array 612 or the instrument itself which is capable of moving within a pre-determined boundary (e.g., sliding, rotating, etc.) relative to the fixed markers 804” [0127]. Therefore, since the tool 608 can include or more moveable markers 806 which are otherwise attached to the implant holder 608B, 608C or to the instrument itself, the surveillance marker includes a plurality of surveillance markers (i.e. one or more) positioned apart from the tracking array (i.e. 612) which are trackable by the tracking device (i.e. camera, see [0008] as discussed in claims 1 and 10 above.).
Regarding claims 7 and 16, Crawford in view of Burger discloses all features of the claimed invention as discussed with respect to claims 1 and 10 above, and Crawford further teaches “wherein the surveillance marker is configured to be radially movable with respect to the central axis of the instrument” (Claim 7); “wherein the surveillance marker is configured to be movable radially outwardly and linearly with respect to the central axis of the instrument” (Claim 16) (See [0127] as discussed with respect to claims 1 and 10 above, “In this case, the moveable marker 806 moves closer to the fixed markers 804 when the implant 10 is expanded, although it is contemplated that this movement may be reversed or otherwise different. The amount of linear translation of the marker 806 would correspond to the height of the implant 10” [0128]; and FIGS. 17A-17B and 18A-18B. As shown in FIGS. 17A-17B and 18A-18B, the moveable marker 806 moves along the central axis of the shaft. Therefore, the surveillance marker (i.e. 806) is configured to be radially movable with respect to the central axis of the instrument (i.e. shaft 622). Furthermore, the surveillance marker (i.e. 806) is configured to be movable radially outwardly (i.e. see positions of 806 in FIGS. 17A and 18A verses the positions of 806 in FIGS. 17B and 18B) and linearly with respect to the central axis of the instrument.).
Regarding claims 8 and 17, Crawford in view of Burger discloses all features of the claimed invention as discussed with respect to claims 1 and 10 above, and Crawford further teaches “wherein determining a circumferential position of the tracking array includes determining 3D coordinates of the tracking markers by the tracking device associated with a surgical robot” (Claims 8 and 17) (See [0007] and [0008] as discussed with respect to claims 1 and 10 above and [0092] as discussed with respect to claims 2 and 11 above. Therefore, the step of determining a circumferential position of the tracking array (i.e. 612) includes determining 3D coordinates of the tracking markers (i.e. 804) by the tracking device (i.e. camera, see [0008]) associated with a surgical robot (see robot in [0008]).).
Regarding claim 15, Crawford in view of Burger discloses all features of the claimed invention as discussed with respect to claim 10 above, and Crawford further teaches “wherein the surveillance marker is spaced from the tracking array” (“A single tracking marker 1018, similar to the other tracking markers described herein, may be rigidly affixed to the guide tube 1014. This single marker 1018 can serve the purpose of adding missing degrees of freedom to allow full rigid body tracking and/or can serve the purpose of acting as a surveillance marker to ensure that assumptions about robot and camera positioning are valid” [0108] and “When tracking the tool 608, such as implant holder 608B, 608C, the tracking array 612 may contain a combination of fixed markers 804 and one or more moveable markers 806 which make up the array 612 or is otherwise attached to the implant holder 608B, 608C. […] In addition, at least one marker 806 is present which can be attached to the array 612 or the instrument itself which is capable of moving within a pre-determined boundary (e.g., sliding, rotating, etc.) relative to the fixed markers 804” [0127]. As shown in FIG. 15B, the single tracking marker 1018 is attached to the guide tube 1014 and is spaced away from the tracking array 612 (i.e. attached to the tool 608, see FIGS. 17A-17B, 18A-18B). Furthermore, since the one or more moveable markers 806 (i.e. surveillance markers) may be otherwise attached to the implant holder 608B, 608C or on the instrument itself, the surveillance marker is spaced from the tracking array (i.e. 612). Therefore, the surveillance marker is spaced from the tracking array.).
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Crawford et al. US 2016/0256225 A1 “Crawford” and Burger US 2009/0099445 A1 “Burger” as applied to claim 1 above, and further in view of Stetz et al. US 2008/0039866 A1 “Stetz”.
Regarding claim 6, Crawford in view of Burger discloses all features of the claimed invention as discussed with respect to claim 1 above, however, the combination does not teach “wherein the surveillance marker includes at least two centerline markers positioned on the central axis of the instrument and at least two offset markers offset laterally with respect to the central axis of the instrument”.
Stetz is within a related field of endeavor to the claimed invention because it involves a locating guide for locating a target tissue site such that a clinician has a reference when orienting a medical element introducer to access the target tissue site (see [Abstract]).
Stetz teaches “wherein the surveillance marker includes at least two centerline markers positioned on the central axis of the instrument and at least two offset markers offset laterally with respect to the central axis of the instrument” (“Locating guide 30 may be used to guide a clinician during a target nerve site 16 location technique. […] For example, a clinician may position locating guide 30 on a skin surface of patient 18 proximate to sacrum 22 in order to aid in locating a target sacral foramen 20 (FIG. 1). Locating guide 30 further includes distance reference markers 34, 36, centerline reference markers 38, and lateral reference markers 40 along first portion 32A of body 32, and distance reference markers 42, 44, centerline reference markers 46, and lateral reference markers 48 along second portion 32B” [0035]; “FIG. 3 illustrates one technique for identifying a location of a target sacral foramen with the aid of locating guide 30. As previously described, it may be useful to locate a sacral foramen in order to implant a medical device, such as a medical lead or a catheter, near a sacral nerve” [0054]. In this case, since the locating guide 30 includes a plurality of markers, the locating guide 30 represents a surveillance marker which aids in identifying a target nerve site. As shown in FIG. 3, the second portion 32B of the locating guide 30 aligns with the spinal canal 66, therefore, the examiner is interpreting the axis that goes through the second portion 32B to represent the central axis of the instrument (i.e. the locating guide). As shown in FIG. 2A, the lateral reference markers 40 are offset from the central axis (i.e. of the second portion 32B) of the instrument and the centerline reference markers 46 are positioned on the central axis (i.e. of the second portion 32B) of the instrument. Therefore, the surveillance marker (i.e. locating guide) includes at least two centerline markers (i.e. centerline reference markers 46) positioned on the central axis of the instrument (i.e. the axis going through second portion 32B) and at least two offset markers (i.e. lateral reference markers 40) offset laterally with respect to the central axis of the instrument (i.e. the axis going through second portion 32B).).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the surveillance marker of Crawford such that it includes at least two centerline markers positioned on the central axis of the instrument and at least two offset markers offset laterally with respect to the central axis of the instrument as disclosed in Stetz in order to enable a clinician to easily identify the location of a target site (i.e. a target nerve site, for example) when preparing to implant a medical device therein (see Stetz: [0035]; [0054]). Utilizing a locating guide 30 (i.e. surveillance marker) with at least two centerline markers (i.e. 46 in Stetz FIG. 2A) and at least two offset markers (i.e. 40 in Stetz FIG. 2A) is one of a finite number of techniques which can be used to identify a target nerve site with a reasonable expectation of success. Thus modifying the surveillance marker of Crawford to include at least two centerline markers and at least two offset markers as disclosed in Stetz would yield the predictable result of enabling a clinician to easily identify the location of a target site when performing a medical procedure.
Claim(s) 9 and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Crawford et al. US 2016/0256225 A1 “Crawford” and Burger US 2009/0099445 A1 “Burger” as applied to claims 1 and 10 above, and further in view of Gullotti et al. US 2019/0209080 A1 “Gullotti”.
Regarding claims 9 and 18, Crawford discloses all features of the claimed invention as discussed with respect to claims 1 and 10 above, however, the combination does not teach “wherein the surveillance marker is configured to be swivelable at an angle with respect to the central axis of the instrument” (Claims 9 and 18).
Gullotti is within the same field of endeavor as the claimed invention because it involves utilizing a 3D tracked probe (See [0541]).
Gullotti teaches “wherein the surveillance marker is configured to be swivelable at an angle with respect to the central axis of the instrument” (Claims 9 and 18) (“Some embodiments of the invention include a 3D-tracked probe, equipped with a tracked DRF and a tracked mobile stray marker (TMSM) that can be actuated by a user and utilized to indicate analog and/or binary information to the acquisition system software. […] By the user actuating a tracked mobile stray marker that rotates about a pivot point in the probe shaft, the location of the tracked mobile stray marker can be computed relative to the DRF, and when visualized in certain positions, can be used to communicate varying messages to the acquisition system's software. […] a TMSM 1525 coupled to an arm 1530 that rotates about a pivot hinge 1550 on a hexagonal extruded probe shaft 1505. […] This probe 1500 is designed to have the TMSM 1525 rotate about the pivot hinge 1550 when a user depresses or releases the depressible tab 1570. The location and relative angle of the TMSM 1525 to the DRF 1510 is computed by the acquisition software of any of the disclosed systems” [0541] and “The arc that is traveled by the tracked mobile stray marker (marked as 1509) can be visualized and computed by the computer system by comparing the location of the TMSM 1525 relative to the tracked DRF 1510 as it is actuated via the depressible tab 1570, with examples depicted in FIGS. 15A-15C. The location and angle of the tracked mobile stray marker 1525 relative to the DRF 1510 can be calculated as will be described in more detail in relation to FIGS. 63 and 64A-64B” [0544].
As shown in FIGS. 15B and 15C, when the tab 1570 is depressed, the tracked mobile stray marker (TMSM) 1525 moves from the center (i.e. central axis) of the instrument (i.e. see FIG. 15B) to the left side of the instrument (see FIG. 15C) at an angle. Thus, the TMSM 1525 represents a surveillance marker which is configured to be swivelable (i.e. along arc 1509) at an angle with respect to the central axis of the instrument.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the surveillance array of Crawford such that it is configured to be swivelable at an angle with respect to the central axis of the instrument as disclosed in Gullotti in order to allow a user to better visualize certain positions and communicate varying messages to the acquisition system’s software (see Gullotti: [0541]). Rotating/swiveling a tracked mobile stray marker (i.e. surveillance marker) about a pivot point in a probe shaft is one of a finite number of techniques which can be used to allow a user to visualize certain positions and communicate varying messages to a system’s software with a reasonable expectation of success. Thus, modifying the surveillance array of Crawford such that it is configured to be swivelable at an angle with respect to the central axis of the instrument as disclosed in Gullotti would yield the predictable result of enabling better visualization of certain positions and communication of varying messages to the system (See Gullotti: [0541]).
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KAITLYN E SEBASTIAN whose telephone number is (571)272-6190. The examiner can normally be reached Mon.- Fri. 7:30-4:30 (Alternate Fridays Off).
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anne M Kozak can be reached at (571) 270-0552. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/KAITLYN E SEBASTIAN/Examiner, Art Unit 3797