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 .
Claim Status: Claims 1-20 are pending; Claims 12-20 have been withdrawn from consideration
Election/Restrictions
Applicant’s election without traverse of Species A in the reply filed on July 1, 2026 is acknowledged.
Response to Arguments
Applicant's arguments filed on July 1, 2026 have been fully considered but they are not persuasive.
Applicant made an argument that Aubin does not disclose the amended limitation “generating an implant loosening score from the implant vibration data and the patient reported data indicative of a movement of the implant with respect to the bone”.
This argument has been considered but is not persuasive.
Aubin discloses the amended limitation as claim mapped as following: generating the implant loosening score (fig. 16A, para. [0171], movement classification model; para. [0336], 4) clinical outcome data 1626, such as implant loosening, implant instability, stiffness, infection, revision surgery, pain, abnormal motions (e.g., limping), healing date, and patient reported outcome scores; fig. 20, para. [0457], movement classification model 2006 receives input of clinical outcome data 2026 and kinematic data. If so trained, the classification model 2006 may provide other types of diagnostic or prognostic outcomes such as risk of infection, or implant loosening, or likelihood of full recovery.) includes detecting an increase in the implant vibration data (para. [0384], A high amount of high frequency content in a spectral distribution graph relative to other, lower frequency content may be indicative of implant micromotion or vibration that may be predictive of latter implant loosening; para. [0140], Analysis of kinematic data may also detect implant complications, e.g., micromotion, contracture, aseptic loosening, and infection, that may require an early intervention, such as bracing, changing one or more components of the implant, administration of systemic or local antibiotics, or manipulation of the extremity and implant. The intelligent implant can also monitor displacement or movement of the component or implant system.) and a rise in the patient reported data indicative of a movement of the implant with respect to the bone (para. [0342], The clinical movement type data 1628 associated with a patient dataset 1610 may be obtained through clinical observation or through a patient diary or log of daily movement types. For example, the body part may be a tibia and the associated movement type for a record may be a normal movement (e.g., walking with a normal gait, running with a normal gait, walking upstairs with a normal gait, walking down stairs with a normal gait, walking up a slope with a normal gait, walking down a slope with a normal gait, biking) or an abnormal movement type (e.g., walking with a limp, walking with a limited range of motion, walking with a shuffle, walking with an assisted device (e.g., a cane, a walker, etc.), running with a limp, running with a limited range of motion, walking with an abnormal gait such an antalgic gait or a bow-legged gait.).
Regarding 101 rejection, Applicant made an argument that the limitation “receiving implant vibration data from an implant coupled to a bone of a patient, the implant vibration data being generated by a sensor associated with the implant” is not a mental process. As to Step 2A, Applicant also argued that the amended limitation recites a special technical mechanism that provides a concrete improvement to post-arthroplasty implant monitoring rather than a generic effort directed to an abstract idea. As to Step 2B, Applicant argued that “acquiring vibration data from a sensor associated with an implant coupled to a patient’s bone and generating an implant loosening score by detecting an increase in such vibration data together with a rise in patient-reported data, are not well-understood, routine, or conventional.”
These arguments have been considered but are not persuasive.
Based on cited court decision, See Electric Power Group, LLC v. Alstom, “receiving implant vibration data from an implant coupled to a bone of a patient, the implant vibration data being generated by a sensor associated with the implant” is an abstract idea. Even if Applicant disagrees and argues that it is not an abstract idea. It would not be more than insignificant extra-solution activity (See MPEP 2106.05(g)).
Applicant is reminded that abstract ideas cannot provide a practical application or significantly more (e.g., an improvement). Both Step 2A Prong 2 and Step 2B require an additional element, not an abstract idea, to provide a practical application or significantly more (e.g., an improvement). See Genetic Technologies Limited v. Merial LLC (Fed Cir 2016). Here, the limitations “generating an implant loosening score by detecting an increase in such vibration data together with a rise in patient-reported data” are abstract ideas and not additional elements.
See MPEP 2106.05(a), wherein “[i]t is important to note, the judicial exception alone cannot provide the improvement. The improvement can be provided by one or more additional elements. See the discussion of Diamond v. Diehr, 450 U.S. 175, 187 and 191-92, 209 USPQ 1, 10 (1981)) in subsection II, below. In addition, the improvement can be provided by the additional element(s) in combination with the recited judicial exception. See MPEP § 2106.04(d) (discussing Finjan, Inc. v. Blue Coat Sys., Inc., 879 F.3d 1299, 1303-04, 125 USPQ2d 1282, 1285-87 (Fed. Cir. 2018)). Thus, it is important for examiners to analyze the claim as a whole when determining whether the claim provides an improvement to the functioning of computers or an improvement to other technology or technical field.”
In response to Applicant’s argument that “acquiring vibration data from a sensor associated with an implant coupled to a patient’s bone” is not well-understood, routine, or conventional.
The courts have recognized the following computer functions as well‐understood, routine, and conventional functions when they are 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)):
Receiving or transmitting data over a network, e.g., using the Internet to gather data, Symantec, 838 F.3d at 1321, 120 USPQ2d at 1362 (utilizing an intermediary computer to forward information); TLI Communications LLC v. AV Auto. LLC, 823 F.3d 607, 610, 118 USPQ2d 1744, 1745 (Fed. Cir. 2016) (using a telephone for image transmission); OIP Techs., Inc., v. Amazon.com, Inc., 788 F.3d 1359, 1363, 115 USPQ2d 1090, 1093 (Fed. Cir. 2015) (sending messages over a network); buySAFE, Inc. v. Google, Inc., 765 F.3d 1350, 1355, 112 USPQ2d 1093, 1096 (Fed. Cir. 2014) (computer receives and sends information over a network); but see DDR Holdings, LLC v. Hotels.com, L.P., 773 F.3d 1245, 1258, 113 USPQ2d 1097, 1106 (Fed. Cir. 2014) ("Unlike the claims in Ultramercial, the claims at issue here specify how interactions with the Internet are manipulated to yield a desired result‐‐a result that overrides the routine and conventional sequence of events ordinarily triggered by the click of a hyperlink."
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-11 are rejected under 35 U.S.C. 101 because the claimed invention is directed to abstract idea without significantly more. The claim(s) recite(s) a method.
To determine whether a claim satisfies the criteria for subject matter eligibility, the claim is evaluated according to a stepwise process as described in MPEP 2106(III) and 2106.03-2106.04.
The instant claims are evaluated according to such analysis.
Step 1: Is the claim to a process, machine, manufacture or composition of matter?
Yes, Claim 1 is directed towards a method.
Step 2A (Prong 1): Does the claim recite an abstract idea, law of nature, or natural phenomenon?
Yes, the judicial exception relied upon by the instantly claimed invention is an abstract idea, and the limitation that sets forth or describes the abstract idea is: receiving implant vibration data from an implant coupled to a bone of a patient, the implant vibration data being generated by a sensor associated with the implant; receiving patient reported data from the patient, and generating an implant loosening score from the implant vibration data and the patient reported data, wherein the implant loosening score is related to movement of implant with respect to the bone, wherein generating the implant loosening score includes detecting an increase in the implant vibration data and a rise in the patient reported data indicative of a movement of the implant with respect to the bone.
The reason that the above limitations are abstract idea is because they are directed to mental process (observation, evaluation, judgment, opinion). The above steps can be performed in the mind or by hand. The above limitation is merely receiving data and analyzing the data.
The 2019 revised§ 101 guidance makes clear that the "mental process" category of abstract ideas does not only apply to steps actually carried out mentally; it also applies to the types of processes that could be carried out mentally, but are instead carried out using generic processing/collection technology.
Please see the following analogous types of data manipulations that courts have found to be abstract ideas (all taken from MPEP § 2106.04):
collecting information, analyzing it, and displaying certain results of the collection and analysis, Electric Power Group, LLC v. Alstom, S.A., 830 F.3d 1350, 1351-52, 119 USPQ2d 1739, 1740 (Fed. Cir. 2016)
Step 2A (Prong 2): Does the claim recite additional elements that integrate the judicial exception into a practical application?
No, the claim does not recite additional element.
Step 2B: Does the claim recite additional elements that amount to significantly more than the judicial exception?
No, the claim does not recite additional element.
Therefore, the claim is not patent eligible.
With regards to the instantly rejected dependent claims 2-11, these claims when analyzed as a whole are also held to be patent ineligible under 35 U.S.C. 101 because the additional recited limitation(s) fail(s) to establish that the claim(s) is/are not directed to a judicial exception and/or do not add significantly more to the judicial exception. Therefore, the claim(s) is/are not patent eligible.
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 1-11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Aubin et al. (US 2023/0022710).
Re Claim 1, Aubin discloses a method for determining an implant condition, the method comprising the steps of:
receiving implant vibration data from an implant coupled to a bone of a patient, the implant vibration data being generated by a sensor associated with the implant (para. [0384], [0500], implant micromotion or vibration that may be predictive of latter implant loosening. Micromotion can be detected by the accelerometer as high frequency vibrations; para. [0140], analysis of kinematic data may also detect implant complications e.g., micromotion, aseptic loosening.);
receiving patient reported data from the patient (fig. 16A, para. [0336], clinical outcome data 1626 including pain), and
generating an implant loosening score from the implant vibration data and the patient reported data (fig. 20, para. [0457], [0468], movement classification model 2006 receives input of clinical outcome data 2026 and kinematic data. If so trained, the classification model 2006 may provide other types of diagnostic or prognostic outcomes such as risk of infection, or implant loosening, or likelihood of full recovery. These outcomes may be quantified in terms of a percentage or scale value (e.g., on a scale of 1 to 10, a patient's level of risk of infection is x),
wherein the implant loosening score is related to movement of implant with respect to the bone (para. [0117], it may be configured to be secured very close to an implantable medical device that is placed within the bone of that limb, e.g., a humerus or a femur, during a joint arthroplasty; para. [0140], [0384], implant micromotion or vibration that may be predictive of latter implant loosening),
wherein generating the implant loosening score (fig. 16A, para. [0171], movement classification model; para. [0336], 4) clinical outcome data 1626, such as implant loosening, implant instability, stiffness, infection, revision surgery, pain, abnormal motions (e.g., limping), healing date, and patient reported outcome scores; fig. 20, para. [0457], movement classification model 2006 receives input of clinical outcome data 2026 and kinematic data. If so trained, the classification model 2006 may provide other types of diagnostic or prognostic outcomes such as risk of infection, or implant loosening, or likelihood of full recovery.) includes detecting an increase in the implant vibration data (para. [0384], A high amount of high frequency content in a spectral distribution graph relative to other, lower frequency content may be indicative of implant micromotion or vibration that may be predictive of latter implant loosening; para. [0140], Analysis of kinematic data may also detect implant complications, e.g., micromotion, contracture, aseptic loosening, and infection, that may require an early intervention, such as bracing, changing one or more components of the implant, administration of systemic or local antibiotics, or manipulation of the extremity and implant. The intelligent implant can also monitor displacement or movement of the component or implant system.) and a rise in the patient reported data indicative of a movement of the implant with respect to the bone (para. [0342], The clinical movement type data 1628 associated with a patient dataset 1610 may be obtained through clinical observation or through a patient diary or log of daily movement types. For example, the body part may be a tibia and the associated movement type for a record may be a normal movement (e.g., walking with a normal gait, running with a normal gait, walking upstairs with a normal gait, walking down stairs with a normal gait, walking up a slope with a normal gait, walking down a slope with a normal gait, biking) or an abnormal movement type (e.g., walking with a limp, walking with a limited range of motion, walking with a shuffle, walking with an assisted device (e.g., a cane, a walker, etc.), running with a limp, running with a limited range of motion, walking with an abnormal gait such an antalgic gait or a bow-legged gait.).
Re Claim 2, Aubin discloses that the step of generating the implant loosening score includes generating the implant loosening score based on pre-surgery data of the patient (para. [0334], patient medical data 1622 including pre-operation range of motion and bone density; fig. 20, para. [0457], [0468], movement classification model 2006 receives input of medical data 2022. If so trained, the classification model 2006 may provide other types of diagnostic or prognostic outcomes such as risk of infection, or implant loosening, or likelihood of full recovery.).
Re Claim 3, Aubin discloses that the step of generating the implant loosening score includes generating the implant loosening score based on a database of implant loosening scores of multiple patients (fig. 15, fig. 23, para. [0060], tracking patient recovery and/or implant condition relative to a similar patient population; para. [0093], Connecting the IMU data to these health opportunities can be facilitated by the careful construction of clinically relevant biomarkers that can capture diagnostic, prognostic and potentially predictive features which can then be used to understand and characterize patient populations as well as evaluate the individual-level recovery process; para. [0323], [0324], fig. 15, database 1516, The information may be used by the tracking standard processor 1508 to generate a standard dataset that provides information for tracking the recovery of a subject patient relative to a similar patient population or the tracking the condition of a surgical implant; para. [0326], [0331], To improve the accuracy of the machine-learning model in classifying movement type, data preprocessing measures are taken to ensure quality and consistency of the kinematic data across the patient population that is used to train the machine-learning model; para. [0336], 4) clinical outcome data 1626, such as implant loosening, implant instability; para. [0457], if so trained, the classification model 2006 may provide other types of diagnostic or prognostic outcomes such as risk of infection, or implant loosening, or likelihood of full recovery – This disclosure uses implant loosening data of patient population to train the classification model and provide the diagnostic outcome of the patient’s implant loosening).
Re Claim 4, Aubin discloses that the implant is a joint implant (para. [0106], [0173], an intelligent implant, e.g., knee prosthesis 1072 with an IRP 104 a, implanted to replace his left knee joint).
Re Claim 5, Aubin discloses that the sensor is any of an inertial measurement unit sensor, accelerometer, gyroscope, Hall sensor, pH sensor, a temperature sensor and a pressure sensor operatively coupled to a processor of the joint implant (para. [0015], [0117], the implant includes a plurality of sensors; para. [0100], Examples of a kinematic sensor include accelerometer and gyroscope; para. [0135], list of other sensors).
Re Claim 6, Aubin discloses that the implant includes a plurality of sensors (para. [0015], [0117], the implant includes a plurality of sensors; para. [0100], Examples of a kinematic sensor include accelerometer and gyroscope; para. [0135], list of other sensors).
Re Claim 7, Aubin discloses that the joint implant is a knee joint implant (para. [0106], [0173], an intelligent implant, e.g., knee prosthesis 1072 with an IRP 104 a, implanted to replace his left knee joint).
Re Claim 8, Aubin discloses that the patient reported data includes pain level associated with the knee joint implant (fig. 16A, para. [0336], clinical outcome data 1626 including pain).
Re Claim 9, Aubin discloses that the implant loosening score is a single numerical value (fig. 20, para. [0457], [0468], movement classification model 2006 receives input of clinical outcome data 2026 and kinematic data. If so trained, the classification model 2006 may provide other types of diagnostic or prognostic outcomes such as risk of infection, or implant loosening, or likelihood of full recovery. These outcomes may be quantified in terms of a percentage or scale value (e.g., on a scale of 1 to 10, a patient's level of risk of infection is x).
Re Claim 10, Aubin discloses that the implant loosening score includes multiple numerical values (para. [0347], micromotion, stiffness, pain/no pain).
Re Claim 11, Aubin discloses that the implant loosening score is generated as a graphical plot (para. [0346], [0347], graphical representation of micromotion, stiffness, and pain/no pain displayed on user interface and display).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to VYNN V HUH whose telephone number is (571)272-4684. The examiner can normally be reached Monday to Friday from 9 am to 5 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Benjamin Klein can be reached at (571) 270-5213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JONATHAN T KUO/Primary Examiner, Art Unit 3792
/V.V.H./
Vynn Huh, August 13, 2026
Examiner, Art Unit 3792
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