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 .
Election/Restrictions
Claims 15-33 are withdrawn (and further cancelled) from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 5/13/2026.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 5/29/2024 and 11/14/2024 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
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 1-14 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.
Each of Claims 1-14 has been analyzed to determine whether it is directed to any judicial exceptions.
Step 2A, Prong 1
Each of Claims 1-14 recites at least one step or instruction for computing required PCL length from planned implant positions and outputting the two as a function of knee angle, which is grouped as a mental process under the 2019 PEG or a certain method of organizing human activity under the 2019 PEG. Accordingly, each of Claims 1-14 recites an abstract idea.
Specifically, Claim 1 recites a data processing method that determines PCL’s femoral and tibial attachment positions, measures the tibia’s displacement at multiple knee angles to compute the PCL’s maximum length, computers the required PCL length from planned femoral/tibial implant positions and outputs a comparison of required versus maximum PCL length as a function of knee angle (observation, judgment or evaluation, which is grouped as a mental process under the 2019 PEG);
Further, dependent Claims 2-14 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.
Step 2A, Prong 2
The above-identified abstract idea in each of independent Claims 1 (and their respective dependent Claims 2-14) is not integrated into a practical application under 2019 PEG because the additional elements (identified above in independent Claims 1), either alone or in combination, generally link the use of the above-identified abstract idea to a particular technological environment or field of use. More specifically, the additional elements of: a processing apparatus (Claim 1), a non-transitory computer readable medium (Claim 11), a processor (Claim 12), and a tracking system or surgical robot (Claim 14) are generically recited computer elements in independent Claims 1 (and their respective dependent claims) which do not improve the functioning of a computer, or any other technology or technical field. Nor do these above-identified additional elements serve to apply the above-identified abstract idea with, or by use of, a particular machine, effect a transformation 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. 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. For at least these reasons, the abstract idea identified above in independent Claims 1 (and their respective dependent claims) is not integrated into a practical application under 2019 PEG.
Moreover, the above-identified abstract idea is not integrated into a practical application under 2019 PEG 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., a processing apparatus (Claim 1), a non-transitory computer readable medium (Claim 11), a processor (Claim 12), and a tracking system or surgical robot (Claim 14) 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. 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. 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 1 (and their respective dependent claims) is not integrated into a practical application under the 2019 PEG.
Accordingly, independent Claims 1 (and their respective dependent claims) are each directed to an abstract idea under 2019 PEG.
Step 2B
None of Claims 1-14 include additional elements that are sufficient to amount to significantly more than the abstract idea for at least the following reasons.
These claims require the additional elements of: a processing apparatus (Claim 1), a non-transitory computer readable medium (Claim 11), a processor (Claim 12), and a tracking system or surgical robot (Claim 14).
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, 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.
Accordingly, in light of Applicant’s specification, the claimed terms of a processing apparatus (Claim 1), a non-transitory computer readable medium (Claim 11), a processor (Claim 12), and a tracking system or surgical robot (Claim 14) 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.
Furthermore, Applicant’s specification does not describe any special programming or algorithms required for a processing apparatus (Claim 1), a non-transitory computer readable medium (Claim 11), a processor (Claim 12), and a tracking system or surgical robot (Claim 14). 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 Berkheimer memo from April 19, 2018, (III)(A)(1) on page 3). Adding hardware that performs “‘well understood, routine, conventional activit[ies]’ previously known to the industry” will not make claims patent-eligible (TLI Communications).
The recitation of the above-identified additional limitations in Claims 1-14 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 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. 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, 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 of Claims 1-14 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 (ii) providing a technical solution to a problem in a technical field. None of Claims 1-14provides 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.
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 1 (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. That is, 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. 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. As such, there is no inventive concept sufficient to transform the claimed subject matter into a patent-eligible application. 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. Thus, Claims 1-14 merely apply an abstract idea to a computer and do not (i) improve the performance of the computer itself (as in Bascom and Enfish), or (ii) provide a technical solution to a problem in a technical field (as in DDR).
Therefore, none of the Claims 1-14 amounts to significantly more than the abstract idea itself. Accordingly, Claims 1-14 are not patent eligible and rejected under 35 U.S.C. 101.
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.
Claim(s) 1-4 and 7-14 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 20050119661 A1 to Hodgson et al. (hereinafter, Hodgson).
Regarding Claim 1, Hodgson discloses a data processing method carried out by a data processing apparatus and comprising ([0019] “Each of the foregoing aspects of the invention are typically implemented using a CAS system configured with instructions for executing the acts of positional detection and the minimizing calculations required for the methods above. Accordingly, in another aspect, the invention includes CAS systems configured to accomplish the foregoing methods.”) inter alia:
(i) determining a femoral attachment position of a posterior cruciate ligament to a femur of a knee of a patient ([0036] “…a three-ligament model consisting of the two collateral ligaments and the posterior cruciate ligament (PCL) may be used.”) ([0037] “The origins of ligament attachment sites are represented in the femoral frame FF and the insertions of ligament attachment sites are represented in the tibial frame FT.”) ([0034] “…soft tissue constraints are intraoperatively assessed by determining the functional attachment sites… of ligaments…”);
(ii) determining a tibial attachment position of the posterior cruciate ligament to a tibia of the knee of the patient ([0037] “… the insertions of ligament attachment sites are represented in the tibial frame FT.”);
(iii) determining a displacement of the tibia relative to the femur along an anterior-posterior axis of the tibia of the patient for each of a plurality of knee angles while the tibia is moved posteriorly with respect to the femur ([0044] “[0044] i. Anterior/Posterior manipulation”) ([0053] “The seven motions were first performed about the full extension position… 0 degrees… 0 degrees… 30 degrees… 90 degrees… 45 degrees…”);
(iv) determining a maximum length of the posterior cruciate ligament, the maximum length being the distance between the femoral attachment position and the tibial attachment position for each of the plurality of knee angles using the determined displacement, the femoral attachment position and the tibial attachment position ([0092] “The length of each ligament is defined as equal to the difference between its origin and insertion locations.”) ([0039] “… the lengths of the ligaments found by simple subtraction (e.g., position of origin minus position of insertion).”);
(v) determining the position of the femur and the tibia of the knee of the patient arising from a planned femoral implant position and a planned tibial implant position for each of the plurality of knee angles ([0073]-[0076] “Femoral varus/valgus alignment… Femoral internal/external alignment… Femoral anterior/posterior position… Femoral proximal/distal position…”) ([0078]-[0080] “Tibial varus/valgus alignment… Tibial component tilt… Tibial proximal/distal position…”) ([0094] “…at distinct flexion angles in the range of 0 degrees-135 degrees”);
(vi) determining a required length of the posterior cruciate ligament as the distance between the femoral attachment position and the tibial attachment position for each of the plurality of knee angles using the determined positions of the femur and the tibia, the femoral attachment position and the tibial attachment position ([0092] “Let Li be the instantaneous length of the ith ligament, Li its neutral length…” e.g., the instantaneous length being origin minus insertion in the planned configuration, at distinct flexion angles.); and
(vii) outputting a comparison of the required length of the posterior cruciate ligament and the maximum length of the posterior cruciate ligament as a function of knee angle (see Equation 12 in [0097]) ([0105]-[0107] “The sum of all three ligament deviations is computed for the given flexion angle using equation 12. Steps 2-6 are repeated for the entire range of flexion angles. The total ligament deviation for this component placement is computed as the sum of deviation in ligament lengths at each flexion angle.”).
Regarding Claim 2, Hodgson discloses the data processing method of claim 1, further comprising: determining a rollback of the femur relative to the tibia along an anterior-posterior axis of the tibia for each of a plurality of knee angles, and wherein the rollback is also used to determine the required length of the posterior cruciate ligament for each of the plurality of knee angles ([0092] and [0121]).
Regarding Claim 3, Hodgson discloses the data processing method of claim 2, wherein the rollback corresponds to a rollback of the knee when a range of motion test was applied to the native knee of the patient ([0034] and [0053]).
Regarding Claim 4, Hodgson discloses the data processing method of claim 2, wherein rollback corresponds to a fixed amount of rollback of the knee (especially as broadly claimed, any rollback exhibited in a fixed rollback, without further definition of what encompasses a “fixed rollback”, e.g., any rollback amount in “fixed” as it is defined by the distance the rollback occurs).
Regarding Claim 5, Hodgson discloses the data processing method of claim 1, further comprising: receiving a change to the planned femoral implant position and/or a change to the planned tibial implant position, and repeating (v), (vi) and (vii) using the changed planned femoral implant position and/or the changed planned tibial implant position ([0111] and Fig. 9 which shoes recommended soft tissue adjustments, i.e., revaluate loop and changing femoral/tibial placement and repeating (v)-(vii) is disclosed).
Regarding Claim 6, Hodgson discloses the data processing method of claim 1, further comprising: determining an amount of rollback required to prevent the required length of the posterior cruciate ligament exceeding the maximum length of the posterior cruciate ligament; and outputting the amount of rollback.
Regarding Claim 7, Hodgson discloses the data processing method of claim 6, wherein the amount of rollback is determined for a femoral flexion angle of at least 60 degrees of flexion to 90 degrees of flexion.
Regarding Claim 8, Hodgson discloses the data processing method of claim 1, wherein outputting the comparison of the required length of the posterior cruciate ligament and the maximum length of the posterior cruciate ligament as a function of knee angle comprises outputting a graphical display of the required length of the posterior cruciate ligament and the maximum length of the posterior cruciate ligament as a function of knee angle (Fig. 13A graphically plots PCL “Actual – Neutral Length (mm)” against “Flexion Angle (degrees)”).
Regarding Claim 9, Hodgson discloses the data processing method of claim 1, wherein the plurality of knee angles are within the range of 60 degrees of flexion to 90 degrees of flexion ([0053] and [0094]).
Regarding Claim 10, Hodgson discloses the data processing method of claim 1, wherein the number of the plurality of knee angles is at least three ([0053]).
Regarding Claim 11, Hodgson discloses a non-transitory computer readable medium storing instructions executable by a data processor to carry out the data processing method of claim 1 ([0019]).
Regarding Claim 12, Hodgson discloses a data processing apparatus comprising: a processor; and the non-transitory computer readable medium of claim 11 ([0019]).
Regarding Claim 13, Hodgson discloses a computer assisted surgery system including the data processing apparatus of claim 12 ([0019]).
Regarding Claim 14, Hodgson discloses the computer assisted surgery system of claim 13, further comprising: a tracking system ([0019]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SEAN PATRICK DOUGHERTY whose telephone number is (571)270-5044. The examiner can normally be reached 8am-5pm (Pacific Time).
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/SEAN P DOUGHERTY/ Primary Examiner, Art Unit 3791
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