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 . This action is in response to the set of claims received on November 15, 2024. Claims 1-20 are currently pending.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the force sensor (claims 2, 10, and 18); distraction tool (claims 9 and 17); and robot (claim 20) must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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 1-20 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 1-20 has been analyzed to determine whether it is directed to any judicial exceptions.
Step 2A, Prong 1 per MPEP 2106.04(a)
Each of Claims 1-20 recites at least one step or instruction for using a computer system to define a surgical plan based on captured poses of a distracted joint, 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).
Accordingly, each of Claims 1-20 recites an abstract idea.
Specifically, Claim 17 recites a surgical system, comprising: a distraction tool (additional element); and a tracking system (additional element) configured to determine position information of bones of a joint (judgment or evaluation, which is grouped as a mental process in MPEP 2106.04(a)(2)(III));
and a computing system (additional element) communicable with the distraction tool and the tracking system, the computing system programmed to: receive a measurement of a force applied to a first bone of the joint via the distraction tool (observation or evaluation, which is grouped as a mental process in MPEP 2106.04(a)(2)(III)); determine, using first pose information of the first bone and first pose information of a second bone of the joint from the tracking system, a first gap distance between the first bone of the joint and the second bone of the joint(judgment or evaluation, which is grouped as a mental process in MPEP 2106.04(a)(2)(III)); cause, using the first gap distance and the measurement of the force, a modified force to be applied to the first bone(judgment or evaluation, which is grouped as a mental process in MPEP 2106.04(a)(2)(III)); determine, using second pose information of the first bone and second pose information of the second bone from the tracking system, a second gap distance between the first bone and the second bone while the modified force is applied to the first bone(judgment or evaluation, which is grouped as a mental process in MPEP 2106.04(a)(2)(III)); and create an implant placement plan using the second gap distance and a measurement of the modified force(observation or evaluation, which is grouped as a mental process in MPEP 2106.04(a)(2)(III)). Further, independent claims 1 and 9 recite abstract ideas for the same reason as claim 17.
Further, the dependent claims merely include limitations that either further define the abstract idea (and thus don’t 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’re merely incidental or token additions to the claims that do not alter or affect how the process 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 each of independent claims and their respective dependent Claims is not integrated into a practical application under MPEP 2106.04(d) because the additional elements, 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: tracking tool and computing system are generically recited computer elements in independent claims (and their respective dependent claims) 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 (and their respective 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 (e.g., mental process and certain method of organizing human activity) using rules (e.g., computer instructions) executed by a computer (e.g., computing system; tracking system; and distraction tool 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 and their respective dependent claims) is not integrated into a practical application under MPEP 2106.04(d)(I).
Accordingly, independent Claims (and their respective dependent claims) are each directed to an abstract idea according to MPEP 2106.04(d).
Step 2B per MPEP 2106.05
None of Claims 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 computing system; tracking system; and distraction tool. 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, [0034] The surgical system 700 depicted in FIG. 7, used in conjunction with the joint gap balancing lever device 10, is used, for example, to capture the poses of the bones of the joint, as well as others aspects of surgical planning. FIG. 7 illustrates a surgical system 700 that includes a computing system 720, a surgical tool such as haptic device 730, and a tracking system 740. In operation, the surgical system 700 enables comprehensive surgical planning, which may include performing distraction of a joint using the device 10 described herein.
Accordingly, in various embodiments, the computing system 720 is configured to acquire and use the data obtained during a joint distraction procedure, including pose information (e.g., captured in response to the user pressing a button on the device 10), to complete a surgical planning procedure. Thus, computing system 720 may capture and store the pose of the first and second bones of the joint based on information captured and provided by tracking system 740. For example, the captured pose of the joint may be used to plan bone resection and prosthetic implant placement for proper joint balance and alignment. In some embodiments, the computing system 720 of surgical system 700 is further configured to define a surgical plan based on the captured pose(s) of the distracted joint. In some such embodiments, the surgical system 700 then implements the surgical plan, for example, by using the tracking system 740 to track the pose of a surgical tool relative to the patient's anatomy and providing haptic feedback through the haptic device 730 (e.g., based on a position and orientation of a surgical tool 735 relative a haptic boundary created during surgical planning). The haptic feedback provided by the haptic device 730 provides surgical guidance to a surgeon in order to keep the surgical tool 735 from deviating from the surgical plan created based on the joint distraction procedure and other aspects of surgical planning.
Accordingly, in light of Applicant’s specification, the claimed term computing system; tracking system; and distraction tool 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 computing system; tracking system; and distraction tool. 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 activities’ 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 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 claims 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 independent Claims and their 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 amounts to significantly more than the abstract idea itself. Accordingly, Claims 1-20 are not patent eligible and rejected under 35 U.S.C. 101.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-20 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. As to independent claims 1, 9, 17, there is no explanation of the computing system programmed to: receive a measurement of a force applied to a first bone of a joint via the distraction tool; determine a first gap distance between the first bone of the joint and a second bone of the joint and correlate the first gap distance with the measurement of the force; cause, using the first gap distance and the measurement of the force, a modified force to be applied to the first bone; determine a second gap distance between the first bone of the joint and the second bone of the joint while the modified force is applied to the first bone; and create an implant placement plan using the second gap distance and a measurement of the modified force. There is inadequate written description of how the measurement of the force is obtained via a force sensor (claims 2, 10, and 18); the determination of the first and second gap distances (claims 4 and 12), the modified force and instructions to modify a load (claims 5 and13); the second gap distance associated with a maximum gap distance (claims 6 and 14); a convergence between the second gap distance and the modified force (claims 8 and15); computer programing to receive position information of the first bone and the second bone while the force is applied to the first bone of the joint (claim 11); computing programming to capture position information of the first bone and the second bone while the modified force is applied to the first bone (claim 16); computing programing to receive the first pose information of the first bone and the first pose information of the second bone while the force is applied to the first bone of the joint, wherein the second gap distance is associated with a maximum gap distance between the first bone and the second bone (claim 19); and a robot (claim 20).
Claim Rejections - 35 USC § 102
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 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 1-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Otto et al. (US Publication 2019/0388078), hereinafter “Otto”.
Regarding claim 1, Otto discloses a method (700, Figure 7), comprising: receiving a measurement of a force applied to a first bone of a joint via a distraction tool [paragraph 0042]; determining a first gap distance between the first bone of the joint and a second bone of the joint and correlate the first gap distance with the measurement of the force [paragraph 0043]; causing, using the first gap distance and the measurement of the force, a modified force to be applied to the first bone [paragraph 0042]; determining a second gap distance between the first bone of the joint and the second bone of the joint while the modified force is applied to the first bone [paragraphs 0043-0045]; and creating an implant placement plan using the second gap distance and a measurement of the modified force [paragraph 0054].
Regarding claim 2, Otto discloses wherein the measurement of the force is received via a force sensor of the distraction tool [paragraphs 0027-0028].
Regarding claim 3, Otto discloses further comprising receiving position information of the first bone and the second bone while the force is applied to the first bone of the joint [paragraph 0055].
Regarding claim 4, Otto discloses wherein the first gap distance between the first bone and the second bone is determined using the position information of the first bone and the second bone [paragraphs 0056-0057].
Regarding claim 5, Otto discloses wherein causing the modified force to be applied to the first bone comprises providing an instruction to modify a load applied to a proximal portion of a lever body of the distraction tool[paragraph 0054].
Regarding claim 6, Otto discloses wherein the second gap distance is associated with a maximum gap distance between the first bone and the second bone[paragraph 0042].
Regarding claim 7, Otto discloses further comprising identifying a convergence between the second gap distance and the modified force applied to the first bone [paragraph 0043].
Regarding claim 8, Otto discloses further comprising capturing position information of the first bone and the second bone while the modified force is applied to the first bone[paragraph 0043].
Regarding claim 9, Otto discloses a surgical system, comprising: a distraction tool (10); and a computing system (920) communicable with the distraction tool, the computing system programmed to: receive a measurement of a force applied to a first bone of a joint via the distraction tool[paragraph 0042]; determine a first gap distance between the first bone of the joint and a second bone of the joint and correlate the first gap distance with the measurement of the force[paragraph 0043]; cause, using the first gap distance and the measurement of the force, a modified force to be applied to the first bone[paragraph 0042]; determine a second gap distance between the first bone of the joint and the second bone of the joint while the modified force is applied to the first bone[paragraphs 0043-0045]; and create an implant placement plan using the second gap distance and a measurement of the modified force[paragraph 0054].
Regarding claim 10, Otto discloses wherein the measurement of the force is received via a force sensor of the distraction tool[paragraphs 0027-0028].
Regarding claim 11, Otto discloses wherein the computing system is further programmed to receive position information of the first bone and the second bone while the force is applied to the first bone of the joint[paragraph 0055].
Regarding claim 12, Otto discloses wherein the first gap distance between the first bone and the second bone is determined using the position information of the first bone and the second bone [paragraphs 0056-0057].
Regarding claim 13, Otto discloses wherein the computing system is programed to cause the modified force to be applied by providing instruction to modify a load applied to a proximal portion of a lever body of the distraction tool [paragraph 0054].
Regarding claim 14, Otto discloses wherein the second gap distance is associated with a maximum gap distance between the first bone and the second bone [paragraph 0042].
Regarding claim 15, Otto discloses wherein the computing system is further programmed to identify a convergence between the second gap distance and the modified force applied to the first bone[paragraph 0043].
Regarding claim 16, Otto discloses wherein the computing system is further programmed to capture position information of the first bone and the second bone while the modified force is applied to the first bone[paragraph 0043].
Regarding claim 17, Otto discloses a surgical system surgical system, comprising: a distraction tool(10); and a tracking system (940) configured to determine position information of bones of a joint [paragraph 0047]; and a computing system (920) communicable with the distraction tool and the tracking system [paragraph 0043], the computing system programmed to: receive a measurement of a force applied to a first bone of the joint via the distraction tool [paragraph 0042]; determine, using first pose information of the first bone and first pose information of a second bone of the joint from the tracking system, a first gap distance between the first bone of the joint and the second bone of the joint[paragraph 0043]; cause, using the first gap distance and the measurement of the force, a modified force to be applied to the first bone[paragraph 0042]; determine, using second pose information of the first bone and second pose information of the second bone from the tracking system, a second gap distance between the first bone and the second bone while the modified force is applied to the first bone[paragraph 0042]; and create an implant placement plan using the second gap distance and a measurement of the modified force[paragraph 0054].
Regarding claim 18, Otto discloses wherein the measurement of the force is received via a force sensor of the distraction tool[paragraphs 0027-0028].
Regarding claim 19, Otto discloses wherein the computing system is further programmed to receive the first pose information of the first bone and the first pose information of the second bone while the force is applied to the first bone of the joint, wherein the second gap distance is associated with a maximum gap distance between the first bone and the second bone[paragraph 0041-0045].
Regarding claim 19, Otto discloses further comprising a robot (935) capable of guiding a bone resection in accordance with the implant placement plan (i.e., 935 is capable of guiding a surgical tool 935 during a surgical procedure [paragraph 0045]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DIANA S JONES whose telephone number is (571)270-5963. The examiner can normally be reached Monday to Friday (8am to 4pm EST).
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, Kevin Truong can be reached at 571-272-4705. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Diana Jones/Examiner, Art Unit 3775
/KEVIN T TRUONG/Supervisory Patent Examiner, Art Unit 3775
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