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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 18 September 2025 has been entered.
Response to Amendment
This Office Action is responsive to the amendment filed on 18 September 2025. As directed by the amendment: claims 21 and 29 have been amended, and claims 1-20, 22, and 30 are cancelled. Claims 21, 23-29, and 31-40 currently stand pending in the application.
The claim amendments are not sufficient to overcome the claim objections listed in the previous action, which are repeated in relevant part below.
Response to Arguments
Applicant's arguments filed 18 September 2025 with respect to the rejections under 35 U.S.C. 101 have been fully considered but they are not persuasive.
Applicant’s re-alleging of all of the previous arguments are similarly re-addressed with the previous response to arguments in the rejection dated 18 June 2025.
Applicant contends that the entire claim should be reviewed to see whether the claim as a whole recites a mental calculation, and not just one step in the claim. Examiner respectfully submits that the claim as a whole was reviewed as presented in the previous rejection and again below, with multiple steps able to be performed in the human mind, and any additional elements being insignificant extra-solution activity. The at least one step, which in this case includes multiple abstract steps, is not made less abstract by the claimed limitations.
Applicant's arguments filed 18 September 2025 with respect to the rejections under 35 U.S.C. 102 and 103 have been considered but are moot because the new ground of rejection does not rely on any interpretation of the references applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Applicant contends that Tohmeh (US 2015/0100091) does not care what type of screw is being used. Examiner respectfully submits that Tohmeh does disclose that the method depends on the screws used to hold the rods attached to the vertebrae (par. [0005]), and the characteristics of the screw including length must be appropriate for use in spinal surgery, since excessive length would damage nerves or tissues and an insufficient length would not provide strong fixation.
Claim Objections
Claims 23, 27, 31, 36, and 38-40 are objected to because of the following informalities: improper antecedence and language. Appropriate correction is required. Amendment is suggested to delete the roman numerals in parentheses in claims 23, 27, 31, 36, and 38-40.
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 21, 23-29, and 31-40 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
In accordance with MPEP 2106.04, each of Claims 21, 23-29, and 31-40 have been analyzed to determine whether it is directed to any judicial exceptions.
Step 2A, Prong 1 per MPEP 2106.04(a)
Each of Claims 21, 23-29, and 31-40 recites steps or instructions for concepts performed in the human mind, which is grouped as a mental process in MPEP 2106.04(a)(2)(III) or a certain method of organizing human activity in MPEP 2106.04(a)(2)(II) or mathematical concept in MPEP 2106.04(a)(2)(I). The claimed limitations involve observation, evaluation, and/or judgment, which are concepts performed in the human mind (see MPEP 2106.04(a)(2)(III)).
Accordingly, each of Claims 21, 23-29, and 31-40 recites an abstract idea.
Specifically, Claim 21 recites (underlined = abstract idea; bolded = additional element; bolded and underlined = either):
21. A computer-implemented (additional element) method for surgical navigation (evaluation or judgement which is a mental process) under a control of a computer processor (additional element that is insignificant extra-solution activity, e.g., displaying data), the method comprising:
displaying a start-up menu having a selection area on a display screen (additional element that is insignificant extra-solution activity, e.g., displaying data);
receiving a first input from the selection area having case-specific information, the first input comprising one or more vertebral levels of the surgical procedure and a surgical approach (either observation which is a mental process or additional element that is insignificant extra-solution activity, e.g., data collection);
obtaining an image data set based on the first input (either observation which is a mental process or additional element that is insignificant extra-solution activity, e.g., data collection);
displaying a surgical planning menu on the display screen based on the first input (additional element that is insignificant extra-solution activity, e.g., displaying data);
receiving a second input from the surgical planning menu including all of the following: a level selection, a screw type selection, and a screw length selection (either observation which is a mental process or additional element that is insignificant extra-solution activity, e.g., data collection);
displaying a surgical planning screen on the display screen, the surgical planning screen having one or more views of the image data set (additional element that is insignificant extra-solution activity, e.g., displaying data);
receiving a third input from the surgical planning screen including a trajectory of the selected screw (either observation which is a mental process or additional element that is insignificant extra-solution activity, e.g., data collection); and
generating a surgical plan based on the received first input, the second input, and the third input (evaluation or judgement which is a mental process, or an additional element that is insignificant extra-solution activity, e.g., displaying data).
Claim 29 recites the limitations of claim 21 with the additional limitations of a display screen (additional element that is insignificant extra-solution activity, e.g., displaying data); and a computer system (additional element).
Further, dependent Claims 23-28 and 31-40 merely include limitations that either further define the abstract idea (and thus do not make the abstract idea any less abstract) or amount to no more than generally linking the use of the abstract idea to a particular technological environment or field of use because they are merely incidental or token additions to the claims that do not alter or affect how the claimed functions/steps are performed.
Accordingly, as indicated above, each of the above-identified claims recites an abstract idea as in MPEP 2106.04(a).
Step 2A, Prong 2 per MPEP 2106.04(d)
The above-identified abstract idea in independent Claims 21 and 29 (and dependent Claims 23-28 and 31-40) is not integrated into a practical application under MPEP 2106.04(d) because the additional elements (identified above in independent Claims 21 and 29), either alone or in combination, generally link the use of the above-identified abstract idea to a particular technological environment or field of use according to MPEP 2106.05(h). More specifically, the additional elements of: a computer system/computer-implemented method, display screen, menus, and inputs, as recited in the claims, are generically recited computer elements which do not improve the functioning of a computer, or any other technology or technical field according to MPEP 2106.04(d)(1) and 2106.05(a). Nor do these above-identified additional elements serve to apply the above-identified abstract idea with, or by use of, a particular machine according to MPEP 2106.05(b), effect a transformation according to MPEP 2106.05(c), provide a particular treatment or prophylaxis according to MPEP 2106.04(d)(2) or apply or use the above-identified abstract idea in some other meaningful way beyond generally linking the use thereof to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception according to MPEP 2106.04(d)(2) and 2106.05(e). Furthermore, the above-identified additional elements do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a computer in accordance with MPEP 2106.05(f). For at least these reasons, the abstract idea identified above in independent Claims 21 and 29 and their dependent claims is not integrated into a practical application in accordance with MPEP 2106.04(d).
Moreover, the above-identified abstract idea is not integrated into a practical application in accordance with MPEP 2106.04(d) because the claimed method and system merely implements the above-identified abstract idea (mental process) using rules (computer instructions) executed by a computer (computer system including a processor as claimed). In other words, these claims are merely directed to an abstract idea with additional generic computer elements which do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a computer according to MPEP 2106.05(f). Additionally, Applicant’s specification does not include any discussion of how the claimed invention provides a technical improvement realized by these claims over the prior art or any explanation of a technical problem having an unconventional technical solution that is expressed in these claims according to MPEP 2106.05(a). That is, like Affinity Labs of Tex. v. DirecTV, LLC, the specification fails to provide sufficient details regarding the manner in which the claimed invention accomplishes any technical improvement or solution. Thus, for these additional reasons, the abstract idea identified above in independent Claims 21 and 29 (and dependent Claims 23-28 and 31-40) is not integrated into a practical application under MPEP 2106.04(d)(I).
Accordingly, independent Claims 21 and 29 (and dependent Claims 23-28 and 31-40) are each directed to an abstract idea according to MPEP 2106.04(d).
Step 2B per MPEP 2106.05
None of Claims 21, 23-29, and 31-40 include additional elements that are sufficient to amount to significantly more than the abstract idea in accordance with MPEP 2106.05 for at least the following reasons.
These claims require the additional elements of: a computer system/computer-implemented method, display screen, menus, and inputs.
The above-identified additional elements are generically claimed computer components which enable the above-identified abstract idea(s) to be conducted by performing the basic functions of automating mental tasks. The courts have recognized such computer functions as well understood, routine, and conventional functions when claimed in a merely generic manner (e.g., at a high level of generality) or as insignificant extra-solution activity. See, MPEP 2106.05(d)(II) along with Versata Dev. Group, Inc. v. SAP Am., Inc., 793 F.3d 1306, 1334, 115 USPQ2d 1681, 1701 (Fed. Cir. 2015); and OIP Techs., 788 F.3d at 1363, 115 USPQ2d at 1092-93.
Per Applicant’s specification, the computer system 12 is shown as a schematic drawing (see e.g. FIG. 1) and includes a control unit including a processor configured to execute computer executable instructions (i.e. software) (page 12 / lines 6-18).
Accordingly, in light of Applicant’s specification, the claimed terms of a computer system/computer-implemented method, display screen, menus, and inputs are reasonably construed as a generic computing device. Like SAP America vs Investpic, LLC (Federal Circuit 2018), it is clear, from the claims themselves and the specification, that these limitations require no improved computer resources, just already available computers, with their already available basic functions, to use as tools in executing the claimed process. See MPEP 2106.05(f).
Furthermore, Applicant’s specification does not describe any special programming or algorithms required for the computer system/computer-implemented method, display screen, menus, and inputs. This lack of disclosure is acceptable under 35 U.S.C. §112(a) since this hardware performs non-specialized functions known by those of ordinary skill in the computer arts. By omitting any specialized programming or algorithms, Applicant's specification essentially admits that this hardware is conventional and performs well understood, routine and conventional activities in the computer industry or arts. In other words, Applicant’s specification demonstrates the well-understood, routine, conventional nature of the above-identified additional elements because it describes these additional elements in a manner that indicates that the additional elements are sufficiently well-known that the specification does not need to describe the particulars of such additional elements to satisfy 35 U.S.C. § 112(a) (see MPEP 2106.05(d)(I)(2) and 2106.07(a)(III)). Adding hardware that performs “‘well understood, routine, conventional activit[ies]’ previously known to the industry” will not make claims patent-eligible (TLI Communications along with MPEP 2106.05(d)(I)).
The recitation of the above-identified additional limitations in the claims amounts to mere instructions to implement the abstract idea on a computer. Simply using a computer or other machinery in its ordinary capacity for economic or other tasks (e.g., to receive, store, or transmit data) or simply adding a general-purpose computer or computer components after the fact to an abstract idea (e.g., a fundamental economic practice or mathematical equation) does not provide significantly more. See MPEP 2106.05(f) along with Affinity Labs v. DirecTV, 838 F.3d 1253, 1262, 120 USPQ2d 1201, 1207 (Fed. Cir. 2016) (cellular telephone); and TLI Communications LLC v. AV Auto, LLC, 823 F.3d 607, 613, 118 USPQ2d 1744, 1748 (Fed. Cir. 2016) (computer server and telephone unit). Moreover, implementing an abstract idea on a generic computer, does not add significantly more, similar to how the recitation of the computer in the claim in Alice amounted to mere instructions to apply the abstract idea of intermediated settlement on a generic computer.
A claim that purports to improve computer capabilities or to improve an existing technology may provide significantly more. See MPEP 2106.05(a) along with McRO, Inc. v. Bandai Namco Games Am. Inc., 837 F.3d 1299, 1314-15, 120 USPQ2d 1091, 1101-02 (Fed. Cir. 2016); and Enfish, LLC v. Microsoft Corp., 822 F.3d 1327, 1335-36, 118 USPQ2d 1684, 1688-89 (Fed. Cir. 2016). However, a technical explanation as to how to implement the invention should be present in the specification for any assertion that the invention improves upon conventional functioning of a computer, or upon conventional technology or technological processes. That is, per MPEP 2106.05(a), the disclosure must provide sufficient details such that one of ordinary skill in the art would recognize the claimed invention as providing an improvement. Here, Applicant’s specification does not include any discussion of how the claimed invention provides a technical improvement realized by these claims over the prior art or any explanation of a technical problem having an unconventional technical solution that is expressed in these claims. Instead, as in Affinity Labs of Tex. v. DirecTV, LLC 838 F.3d 1253, 1263-64, 120 USPQ2d 1201, 1207-08 (Fed. Cir. 2016), the specification fails to provide sufficient details regarding the manner in which the claimed invention accomplishes any technical improvement or solution.
For at least the above reasons, the method and system of Claims 21, 23-29, and 31-40 are directed to applying an abstract idea as identified above on a general purpose computer without (i) improving the performance of the computer itself or providing a technical solution to a problem in a technical field according to MPEP 2106.05(a), or (ii) providing meaningful limitations to transform the abstract idea into a patent eligible application of the abstract idea such that these claims amount to significantly more than the abstract idea itself according to MPEP 2106.04(d)(2) and 2106.05(e).
Taking the additional elements individually and in combination, the additional elements do not provide significantly more. Specifically, when viewed individually, the above-identified additional elements in the independent claims (and relevant dependent claims) do not add significantly more because they are simply an attempt to limit the abstract idea to a particular technological environment according to MPEP 2106.05(h). When viewed as a combination, these above-identified additional elements simply instruct the practitioner to implement the claimed functions with well-understood, routine and conventional activity specified at a high level of generality in a particular technological environment according to MPEP 2106.05(h). When viewed as whole, the above-identified additional elements do not provide meaningful limitations to transform the abstract idea into a patent eligible application of the abstract idea such that the claims amount to significantly more than the abstract idea itself according to MPEP 2106.04(d)(2) and 2106.05(e). Moreover, neither the general computer elements nor any other additional element adds meaningful limitations to the abstract idea because these additional elements represent insignificant extra-solution activity according to MPEP 2106.05(g). As such, there is no inventive concept sufficient to transform the claimed subject matter into a patent-eligible application as required by MPEP 2106.05.
Therefore, for at least the above reasons, none of the Claims 21, 23-29, and 31-40 amounts to significantly more than the abstract idea itself. Accordingly, Claims 21, 23-29, and 31-40 are not patent eligible and rejected under 35 U.S.C. 101.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 21, 23-29, and 31-40 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
As to claims 21 and 29, the limitation “the selected screw” (claim 21 / line 14; claim 29 / line 17) render the claims indefinite, because it lacks proper antecedent basis in the claims. There is no previously recited selected screw. Previous limitations “a screw type selection, and a screw length selection” do not require a selected screw, but rather a type and length of a screw. For examination purposes, the limitations will be interpreted as a selected screw.
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.
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.
Claims 21, 23-25, 28, 29, 31-33, and 37-40 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Application Publication No. US 2015/0100091 to Tohmeh et al. (hereinafter, “Tohmeh”).
As to claim 21, Tohmeh discloses a computer-implemented method for surgical navigation, under a control of a computer processor (par. [0008]-[0011]), the method comprising: displaying a start-up menu having a selection area (area where selections are to be made or where selected items are displayed, header bar 202) on a display screen (200) (par. [0113]), FIG. 16; receiving a first input (e.g. date and time, 210; and rod bending software version and rod bender configuration file, 212) from the selection area having case-specific information (when and where the case is occurring) (par. [0114]), the first input comprising one or more vertebral levels of the surgical procedure (multiple vertebral levels shown in FIG. 16), and a surgical approach (the surgical approach could include the method for correcting the spinal curvature, which is using implanted screws and a rod, which is indicated with the inputs showing the Rod System, FIG. 16; the surgical approach could include the side of the patient the sensor is located on by selecting the left side 242 or right side 244 sensor position button, par. [0117]); obtaining an image data set (254) based on the first input (the patient shown in the patient graphic 254 at that date and time, showing the vertebral levels and the selected surgical approach, as above); displaying a surgical planning menu (left column including 224 and top row including 242/244) on the display screen based on the first input (all displays are based on the first input since they are related to the surgery occurring at that date and time and location); receiving a second input from the surgical planning menu including all of the following: a level selection (250 in FIG. 17) (par. [0117]; choosing 242 or 244 causes 250 to appear), a screw type selection (224 acquires screws of a type appropriate for spinal surgery, and left and/or right screw types, par. [0118]); displaying a surgical planning screen on the display screen, the surgical planning screen having one or more views of the image data set, FIGS. 18-20; receiving a third input from the surgical planning screen including a trajectory of the selected screw (when performing a surgical maneuver to generate a more feasible solution, including backup of the screw, par. [0119], which indicates the trajectory of the screw in the backwards direction from its displayed location); and generating a surgical plan based on the received first input, the second input, and the third input (par. [0122], [0133]).
As to claim 23, Tohmeh discloses the method of claim 21, further comprising: retrieving a stored template (sagittal and coronal views), FIG. 18, and a surgeon profile (surgeon-prescribed clinical objectives, par. [0010]); displaying a menu of the stored template (the stored template views are presented as a menu, or list of options, as left and right on the display) and the surgeon profile (the objectives determine bend instructions which are presented on the display, 196, par. [0010], [0112], FIG. 22, and/or include pre-bends, 298, as part of advanced options menu 292, FIG. 23) on the display screen; and receiving a fourth input from the menu of the stored template and the surgeon profile comprising a selection of any one of (viii) the stored template, (ix) the surgeon profile, or (x) the stored template and the surgeon profile, wherein the displaying of the surgical planning menu and the displaying of the surgical planning screen is based on the fourth input (displaying the surgical planning menu including acquiring screws and choosing L/R sensor is based on the surgeon-prescribed clinical objectives because the objectives determine the rod bend on which the screw choice is based; displaying the surgical planning screen is based on the sagittal and coronal views so that the screw placement and rod shape can be viewed in different planes).
As to claim 24, Tohmeh discloses the method of claim 21, further comprising: displaying a registration menu screen on the display screen (advanced options menu 294 with Rod Tracking option, not shown); receiving a selection of a registration method from the registration menu screen (if Rod Tracking option is selected/pressed on the menu screen, the registration method of digitizing the location of an array is selected, par. [0153]-[0156]); receiving one or more images (par. [0156]), FIGS. 54-55; and performing registration (at least visually) using the one or more images based on the selection of the registration method.
As to claim 25, Tohmeh discloses the method of claim 21, further comprising: displaying an instrument setup menu (advanced options menu 294 with Rod Tracking option, not shown) on the display screen (par. [0153]), FIG. 23; receiving a fourth input from the instrument setup menu comprising a description of an instrument (rod inserter 536, described at least in location and function); displaying an array assignment menu on the display screen (the array assignments are displayed as a menu or list of options of tracked components, 552 and 554 in FIG. 54); receiving a fifth input from the array assignment menu comprising an assignment of an array to the instrument (the tracking array attached to the rod inserter 536, digitized to be assigned to the instrument and visible as such in the display as 554, the fifth input); receiving one or more images of the array and a second array (the array attached to the rod pusher 520) configured to be releasably secured with a vertebra via a connection with a spine pin (where each spinal screw is a threaded spine pin, and the second array is releasably secured with a vertebra via connection of the rod pusher 520 with the spine pin, par. [0156]; images shown in FIGS. 54 and 55); determining a surgical instrument location (by visualizing location of 554) and an anatomy location (by visualizing location of 552, screw head which is attached to the anatomy) based on the one or more images (par. [0156]); generating a surgical representation including a surgical instrument representation (position and pose represented by 554) overlaid on an anatomy representation (position represented by 552) based on the fourth input, the fifth input, the surgical instrument location, and the anatomy location; and displaying the surgical representation on the display screen, FIGS. 54-55.
As to claim 28, Tohmeh discloses the method of claim 21, further comprising: generating a view of a surgical site based on the surgical plan, FIGS. 18-20 and 54-55; and displaying the view of the surgical site on the display screen.
Tohmeh is silent as to the second input including a screw length selection.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to include information regarding the length of the screws to be used, since Tohmeh discloses that the method depends on the screws used to hold the rods attached to the vertebrae (par. [0005]), and the length must be appropriate for use in spinal surgery, since excessive length would damage nerves or tissues and an insufficient length would not provide strong fixation. The input received when acquiring the screws would thus acquire screws of a type appropriate for spinal surgery and a length appropriate for spinal surgery, so that all future steps of the method would be based on the use of appropriate screws to hold the rods attached to the vertebrae.
As to claim 29, Tohmeh discloses a system for surgical navigation, comprising: a display screen (200) (par. [0113]), FIG. 16; and a computer system including a processor (par. [0008]-[0011]), wherein the computer system is configured to: display a start-up menu comprising a selection area (area where selections are to be made or where selected items are displayed, header bar 202) on the display screen; receive a first input (e.g. date and time, 210; and rod bending software version and rod bender configuration file, 212) from the selection area comprising case-specific information (when and where the case is occurring) (par. [0114]), the first input comprising one or more vertebral levels of the surgical procedure (multiple vertebral levels shown in FIG. 16), and a surgical approach (the surgical approach could include the method for correcting the spinal curvature, which is using implanted screws and a rod, which is indicated with the inputs showing the Rod System, FIG. 16; the surgical approach could include the side of the patient the sensor is located on by selecting the left side 242 or right side 244 sensor position button, par. [0117]); obtain an image data set (254) based on the first input (the patient shown in the patient graphic 254 at that date and time, showing the vertebral levels and the selected surgical approach, as above); display a surgical planning menu (left column including 224 and top row including 242/244) on the display screen based on the first input (all displays are based on the first input since they are related to the surgery occurring at that date and time and location); receive a second input from the surgical planning menu comprising all of the following: a level selection (250 in FIG. 17) (par. [0117]; choosing 242 or 244 causes 250 to appear), a screw type selection (224 acquires screws of a type appropriate for spinal surgery, and left and/or right screw types, par. [0118]); display a surgical planning screen on the display screen, the surgical planning screen comprising one or more views of the image data set, FIGS. 18-20; receive a third input from the surgical planning screen comprising a trajectory of the selected screw (when performing a surgical maneuver to generate a more feasible solution, including backup of the screw, par. [0119], which indicates the trajectory of the screw in the backwards direction from its displayed location); and generate a surgical plan based on the received first input, the second input, and the third input (par. [0122], [0133]).
As to claim 31, Tohmeh discloses the system of claim 29, wherein the computer system is further configured to: retrieve a stored template (sagittal and coronal views), FIG. 18, and a surgeon profile (surgeon-prescribed clinical objectives, par. [0010]); display a menu of the stored template (the stored template views are presented as a menu, or list of options, as left and right on the display) and the surgeon profile (the objectives determine bend instructions which are presented on the display, 196, par. [0010], [0112], FIG. 22, and/or include pre-bends, 298, as part of advanced options menu 292, FIG. 23) on the display screen; and receive a fourth input from the menu of the stored template and the surgeon profile comprising a selection of any one of (viii) the stored template, (ix) the surgeon profile, or (x) the stored template and the surgeon profile, wherein to display the surgical planning menu and to display the surgical planning screen is based on the fourth input (displaying the surgical planning menu including acquiring screws and choosing L/R sensor is based on the surgeon-prescribed clinical objectives because the objectives determine the rod bend on which the screw choice is based; displaying the surgical planning screen is based on the sagittal and coronal views so that the screw placement and rod shape can be viewed in different planes).
As to claim 32, Tohmeh discloses the system of claim 29, wherein the computer system is further configured to: display a registration menu screen on the display screen (advanced options menu 294 with Rod Tracking option, not shown); receive a selection of a registration method from the registration menu screen (if Rod Tracking option is selected/pressed on the menu screen, the registration method of digitizing the location of an array is selected, par. [0153]-[0156]); receive one or more images (par. [0156]), FIGS. 54-55; and perform registration (at least visually) using the one or more images based on the selection of the registration method.
As to claim 33, Tohmeh discloses the system of claim 29, wherein the computer system is further configured to: display an instrument setup menu (advanced options menu 294 with Rod Tracking option, not shown) on the display screen (par. [0153]), FIG. 23; receive a fourth input from the instrument setup menu comprising a description of an instrument (rod inserter 536, described at least in location and function); display an array assignment menu on the display screen (the array assignments are displayed as a menu or list of options of tracked components, 552 and 554 in FIG. 54); and receive a fifth input from the array assignment menu comprising an assignment of an array to the instrument (the tracking array attached to the rod inserter 536, digitized to be assigned to the instrument and visible as such in the display as 554, the fifth input).
As to claim 37, Tohmeh discloses the system of claim 29, wherein the computer system is further configured to: generate a view of a surgical site based on the surgical plan, FIGS. 18-20 and 54-55; and display the view of the surgical site on the display screen.
As to claim 38, Tohmeh discloses the system of claim 37, wherein the view of the surgical site on the display screen comprises any one of (viii) a simulated trajectory based on the surgical plan, (ix) a bookmark screw based on the surgical plan (264, FIG. 19; the screws 264 are bookmarked because they are digitized and thus their positions are recorded and stored for later reference in FIG. 20), or (x) a combination of (viii) and (ix).
As to claim 39, Tohmeh discloses the system of claim 38, wherein the computer system is further configured to: receive a fourth input from the view of the surgical site; and based on the fourth input, remove from the view of the surgical site on the display screen any one of (xi) the simulated trajectory, (xii) the bookmark screw, or (xii) a combination of (xi) and (xii) (the fourth input may be visual confirmation that the surgery is complete in which case a shutdown button can be pressed so that everything is removed from the view of the surgical site on the display screen since the display is shutdown, par. [0114], and/or the fourth output may be to choose the history option from the menu which removes the current bookmark screw view and refers back to a previous rod bending solution, par. [0121]).
As to claim 40, Tohmeh discloses the system of claim 29, wherein the one or more views of the image data set comprise any one of (viii) an axial view, (ix) a sagittal view, (x) a coronal view, FIG. 17, or (xi) any combination of (viii)-(x).
Tohmeh is silent as to the second input comprising a screw length selection.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to include information regarding the length of the screws to be used, since Tohmeh discloses that the method depends on the screws used to hold the rods attached to the vertebrae (par. [0005]), and the length must be appropriate for use in spinal surgery, since excessive length would damage nerves or tissues and an insufficient length would not provide strong fixation. The input received when acquiring the screws would thus acquire screws of a type appropriate for spinal surgery and a length appropriate for spinal surgery, so that all future steps of the method would be based on the use of appropriate screws to hold the rods attached to the vertebrae.
Claims 26 and 27 are rejected under 35 U.S.C. 103 as being unpatentable over Tohmeh in view of U.S. Patent Application Publication No. US 2016/0335380 to Franklin et al. (hereinafter, “Franklin”).
As to claim 27, Tohmeh discloses displaying a tool menu (556, calibrate rod; menu options include pressing or not pressing the button) with the surgical representation on the display screen, FIG. 54, the tool menu comprising options that include any one of (viii) a system type option, (ix) an implant type option (calibrating the rod indicates the implant type by its characteristic of rod length as described by the distance and orientation of the rod inserter handle 542 to the rod pusher 520) (par. [0155]), (x) a screw type option of the simulated trajectory, or (xi) any combination of (viii)-(x); receiving a sixth input from the tool menu comprising a selected option (e.g. “calibrate” is selected); and generating the selected option on the surgical representation displayed on the display screen (by displaying the calibrated rod).
As to claim 26, Tohmeh discloses the claimed invention except for generating a simulated trajectory on the surgical representation displayed on the display screen based on the surgical instrument location and the anatomy location.
Franklin teaches generating a simulated trajectory on a surgical representation displayed on a display screen (par. [0088], claim 7) for verification of targeting before performing the surgery to prevent undesirable outcomes.
Accordingly, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to include in Tohmeh’s method the step of generating a simulated trajectory on the surgical representation displayed on the display screen for verification of the path of the rod before performing the surgery to ensure the rod is being implanted in a desired shape and position relative to the screws and to sensitive surrounding tissue to prevent undesirable outcomes, as taught by Franklin. The simulated trajectory on the surgical representation displayed on the display screen would be based on the surgical instrument location and the anatomy location also displayed on the display screen and relative to which the simulated trajectory is to be compared. The display of the calibrated rod on the display screen is also based on the simulated trajectory which is used to guide and assess the movement of the calibrated rod.
Claim 34 is rejected under 35 U.S.C. 103 as being unpatentable over Tohmeh in view of U.S. Patent No. US 7,640,607 to Guertin et al. (hereinafter, “Guertin”).
As to claim 34, Tohmeh discloses the system of claim 33, further comprising: a second array (the array attached to the rod pusher 520) being configured to be releasably secured with a vertebra via a connection with a spine pin (where each spinal screw is a threaded spine pin, and the second array is releasably secured with a vertebra via connection of the rod pusher 520 with the spine pin, par. [0156]; images shown in FIGS. 54 and 55); wherein the computer system is further configured to: receive one or more images of the array and the second array, FIGS. 54-55; determine a surgical instrument location (by visualizing location of 554) and an anatomy location (by visualizing location of 552, screw head which is attached to the anatomy) based on the one or more images (par. [0156]); generate a surgical representation including a surgical instrument representation (position and pose represented by 554) overlaid on an anatomy representation (position represented by 552) based on the fourth input, the fifth input, the surgical instrument location, and the anatomy location; and display the surgical representation on the display screen, FIGS. 54-55.
Tohmeh discloses the claimed invention except for at least one camera configured to track the array and the second array, wherein the computer system is further configured to: receive one or more images of the array and the second array from the at least one camera.
Guertin teaches that an optical sensor can be a camera or an infrared position sensor (col. 23 / lines 20-25).
Accordingly, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to include in Tohmeh’s system at least one camera configured to track the array and the second array, wherein the computer system is further configured to: receive one or more images of the array and the second array from the at least one camera, as taught by Guertin, since Tohmeh discloses that the tracking of the arrays and the providing of the images of the arrays is performed by an infrared position sensor (par. [0117] and [0152]-[0156]) and the simple substitution of one known element for another to obtain predictable results (optical sensing) is within the ordinary skill in the art. The IR sensor in Tohmeh may be replaced with a camera or there may be provided a camera including an IR position sensor, i.e. an infrared camera.
Claims 35 and 36 are rejected under 35 U.S.C. 103 as being unpatentable over Tohmeh in view of Guertin (hereinafter, “Tohmeh/Guertin”), as applied to claim 34 above, and further in view of Franklin.
As to claim 36, Tohmeh/Guertin disclose wherein the computer system is further configured to: display a tool menu (Tohmeh, 556, calibrate rod; menu options include pressing or not pressing the button) with the surgical representation on the display screen, FIG. 54, the tool menu comprising options that include any one of (viii) a system type option, (ix) an implant type option (calibrating the rod indicates the implant type by its characteristic of rod length as described by the distance and orientation of the rod inserter handle 542 to the rod pusher 520) (par. [0155]), (x) a screw type option of the simulated trajectory, or (xi) any combination of (viii)-(x); receive a sixth input from the tool menu comprising a selected option (e.g. “calibrate” is selected); and generate the selected option on the surgical representation displayed on the display screen (by displaying the calibrated rod).
As to claim 35, Tohmeh discloses the claimed invention except for wherein the computer system is further configured to: generate a simulated trajectory on the surgical representation displayed on the display screen based on the surgical instrument location and the anatomy location.
Franklin teaches generating a simulated trajectory on a surgical representation displayed on a display screen (par. [0088], claim 7) for verification of targeting before performing the surgery to prevent undesirable outcomes.
Accordingly, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to include in Tohmeh’s system wherein the computer system is further configured to generate a simulated trajectory on the surgical representation displayed on the display screen for verification of the path of the rod before performing the surgery to ensure the rod is being implanted in a desired shape and position relative to the screws and to sensitive surrounding tissue to prevent undesirable outcomes, as taught by Franklin. The simulated trajectory on the surgical representation displayed on the display screen would be based on the surgical instrument location and the anatomy location also displayed on the display screen and relative to which the simulated trajectory is to be compared. The display of the calibrated rod on the display screen is also based on the simulated trajectory which is used to guide and assess the movement of the calibrated rod.
Conclusion
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/TRACY L KAMIKAWA/Examiner, Art Unit 3775