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 .
Applicant’s arguments filed in the reply on July 2, 2026 were received and fully considered. Claims 1, 2, 5, 17, 20, and 22 were amended. Claim 19 was cancelled. Please see below for more detail.
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 21-25 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.
Regarding Claim 21, the claim(s) recites “a change in vibration signature is detected” which amounts to an abstract idea (mental process).
This judicial exception is not integrated into a practical application because:
- The claims fail to outline an improvement to the technical field.
- The claims fail to apply the judicial exception to effect a particular treatment.
- The claims fail to apply the judicial exception with a particular machine.
- The claims fail to effect a transformation or reduction of a particular article to a different state or thing.
Next, the claim as a whole is analyzed to determine whether any element or a combination of elements, integrates judicial exception into a practical application.
For this part of the 101 analysis, the following additional limitations are considered: “coupling a first implant to a first bone of a joint;”
“coupling a second implant to a second bone of the joint;”
“vibrating at least one of the first or second bones using an acoustic exciter positioned external to the joint to emit a vibration signal through the joint, the vibration signal being transmitted through both the first implant and the second implant;”
“sensing the vibration signal emitted through the joint with a sensor positioned in the any of the first or second implants;”
“outputting a vibration signature from a processor to an external source, the vibration signature being derived from the vibration signal.”
“wherein the outputting step includes outputting the vibration signal at least a first time and a second time, the first time being different from the second time.”
“creating an alert when a change in vibration signature is detected”
The additional elements are insufficient to amount to significantly more than the judicial exception because they seem to merely generally link the use of the judicial exception to a particular technological environment.
Moreover, the claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because they pertain merely to insignificant extrasolution data gathering activities and generic postsolution activity.
Furthermore, implants and sensors are general field of use and processors are generic computer elements used to perform generic computer functions and don’t add significantly more and are well-understood, routine, and previously known to the industry.
None of these limitations, considered as an ordered combination provide eligibility because the claim taken as a whole, does not amount to significantly more than the underlying abstract idea of identifying a change in a vibration signature from received vibration data and does not purport to improve the functioning of the signal processing, or to improve any other technology or technical field. Use of a generic signal processing does not amount to significantly more than the abstract idea itself.
Regarding Claim 22, the claim(s) recites “comparing by the processor the reference movement value to the secondary movement value to determine whether at least one of the first implant and the second implant has moved from an original implanted position.” which amounts to an abstract idea (mental process).
This judicial exception is not integrated into a practical application because:
- The claims fail to outline an improvement to the technical field.
- The claims fail to apply the judicial exception to effect a particular treatment.
- The claims fail to apply the judicial exception with a particular machine.
- The claims fail to effect a transformation or reduction of a particular article to a different state or thing.
Next, the claim as a whole is analyzed to determine whether any element or a combination of elements, integrates judicial exception into a practical application.
For this part of the 101 analysis, the following additional limitations are considered:
“coupling a first implant to a first bone of a joint;
“coupling a second implant to a second bone of the joint, the second implant including an insert contacting the first implant;”
“measuring a reference movement value at a first time after implantation of the first and second implants, the reference movement value being stored as a baseline in a memory of a processor;
“measuring a secondary movement value at a second time;”
The additional elements are insufficient to amount to significantly more than the judicial exception because they seem to merely generally link the use of the judicial exception to a particular technological environment.
Moreover, the claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because they pertain merely to insignificant extrasolution data gathering activities.
Furthermore, implants and inserts are general field of use.
None of these limitations, considered as an ordered combination provide eligibility because the claim taken as a whole, does not amount to significantly more than the underlying abstract idea of comparing movement data over time and does not purport to improve the functioning of the signal processing, or to improve any other technology or technical field. Use of a generic signal processing does not amount to significantly more than the abstract idea itself. Dependent claims 23-25 also do not add significantly more to the exception as they merely add details to the mental steps, add details to the extrasolution data gathering steps, add general field of use components to facilitate the extrasolution data gathering, and add mental steps.
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) 1-2, 4, 10-11, 14, 17-18, and 20-21 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Nycz (US 2009/0187120).
Regarding Claim 1, Nycz teaches an implant system (Abstract, Figs. 1 and 3, [0021]-[0030], [0036]) comprising:
a first implant coupled to a first bone of a joint (Fig. 1, [0021]-[0023], [0025] sensors 120 are implanted at a first bone of a joint, such as a femur 104, [0030] where the sensor may be coupled as part of a larger implant);
a second implant coupled to a second bone of a joint (Fig. 1, [0021]-[0023], [0025] sensors 120 are implanted at a second bone of a joint, such as a tibia 106, [0030] where the sensor may be coupled as part of a larger implant);
an acoustic exciter configured to vibrate at least the first or second bones to emit a vibration signal through the joint, the vibration signal being transmitted through both the first implant and the second implant ([0029], [0031], [0043], [0058] the sensors themselves or a signal generator may be used to output pulse and thus act as acoustic exciters, [0023] where the acoustic excitation causes vibrations, [0029] where the paired sensors on different bones transmit the vibration signal through the joint so that one may receive signals and one may monitor resulting vibration after passing the joint, [0043] where the sensors may use a pulse-echo approach and transmit vibration and measuring the reflection. Thus, Fig. 1’s sensor may vibrate either bone to emit a vibration signal through the joint, the excitation vibration signal may be transmitted through both the first and the second implant);
a transducer to detect the vibration signal of the first implant and the second implant ([0023] sensors 120 detect vibration signals of the first implant and the second implant); and
a processor operatively coupled to the transducer, the processor configured to output a vibration signature from the vibration signal to an external source ([0035]-[0036] where the coupled sensors may also comprises a structure as shown in Fig. 3, where the sensor is operatively coupled to a processor, where functions of the device are coordination by the processor [0034] where the sensor will take readings and output the detected vibration signals to an external source as facilitated by a processor, [0038] where identified tissue characteristics from the data can be output as vibration signatures to the external source).
Regarding Claim 2, Nycz teaches the implant system of claim 1, wherein the first implant is a femoral component of a knee implant and the second implant is a tibial component of a knee implant (See Claim 1 Rejection).
Regarding Claim 4, Nycz teaches the implant system of claim 1, wherein the acoustic exciter is an ultrasound exciter (See Claim 1 Rejection, [0029], [0043]).
Regarding Claim 10, Nycz teaches the implant system of claim 1, wherein the vibration signature includes at least one of a response, peak, amplitude, and magnitude of the vibration signal ([0039], [0049] changes in vibration over a threshold are identified to characterize condition of soft tissue, thus indicating the response, amplitude, and/or magnitude are reviewed in the vibration signature).
Regarding Claim 11, Nycz teaches the implant system of claim 10, wherein a change in the vibration signature over time indicates implant loosening (See Claim 10 Rejection, [0055] sensors measure for particle wear debris and misalignment, which indicate conditions for implant loosening as noted in [0004]).
Regarding Claim 13, Nycz teaches the implant system of claim 1, wherein the external source is any of a computer, tablet, and smartphone ([0032]).
Regarding Claim 17, Nycz teaches a method for monitoring implant movement (Abstract, Figs. 1, 3, and 6, [0021]-[0030], [0036], [0048]), the method comprising:
coupling a first implant to a first bone of a joint (Fig. 1, [0021]-[0023], [0025] sensors 120 are implanted at a first bone of a joint, such as a femur 104, [0030] where the sensor may be coupled as part of a larger implant, Fig. 6, [0048] step 302);
coupling a second implant to a second bone of the joint (Fig. 1, [0021]-[0023], [0025] sensors 120 are implanted at a second bone of a joint, such as a tibia 106, [0030] where the sensor may be coupled as part of a larger implant, Fig. 6, [0048] step 302);
vibrating at least one of the first or second bones using an acoustic exciter positioned external to the joint to emit a vibration signal through the joint, the vibration signal being transmitted through both the first implant and the second implant ([0029], [0031], [0043], [0058] the sensors themselves or a signal generator may be used to output pulse and thus act as acoustic exciters, [0023] where the acoustic excitation causes vibrations, [0029] where the paired sensors on different bones transmit the vibration signal through the joint so that one may receive signals and one may monitor resulting vibration after passing the joint, [0043] where the sensors may use a pulse-echo approach and transmit vibration and measuring the reflection. Thus, Fig. 1’s sensor may vibrate either bone to emit a vibration signal through the joint, the excitation vibration signal may be transmitted through both the first and the second implant, Fig. 6, [0049]-[0059] determine thresholds and monitor joint based upon vibration excitation);
sensing the vibration signal emitted through the joint with a sensor positioned in the any of the first or second implants ([0023] sensors 120 detect vibration signals of the first implant and the second implant, Fig. 6, [0049]-[0059] determine thresholds and monitor joint based upon vibration excitation); and
outputting a vibration signature from a processor to an external source, the vibration signature being derived from the vibration signal ([0035]-[0036] where the coupled sensors may also comprises a structure as shown in Fig. 3, where the sensor is operatively coupled to a processor, where functions of the device are coordination by the processor [0034] where the sensor will take readings and output the detected vibration signals to an external source as facilitated by a processor, [0038] where identified tissue characteristics from the data can be output as vibration signatures to the external source, Fig. 6, [0050]).
Regarding Claim 18, Nycz teaches the method of claim 17, wherein the coupling steps include coupling the first implant to a femur and coupling the second implant to a tibia (See Claim 17 Rejection).
Regarding Claim 20, Nycz teaches the method of claim 17, wherein the outputting step includes outputting the vibration signal at least a first time and a second time, the first time being different from the second time ([0040]-[0042] signals monitored over time with review by a caretaker for calibration purposes).
Regarding Claim 21, Nycz teaches the method of claim 20, further comprising creating an alert when a change in vibration signature is detected ([0065]).
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.
Claim(s) 3, 5-9, and 22-25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nycz in view of Stein et al (US 2014/0275815) (“Stein 815”).
Regarding Claim 3, while Nycz teaches the implant system of claim 2, Nycz fails to teach the implant system further including an insert located between the femoral component and the tibial component.
However Stein teaches an implant system (Figs. 1, 27, 31, and 33, [0187]-[0201], [0216]-[0228] where [0192] teaches a typical knee joint replacement utilizes an insert, a femoral prosthetic component and a tibial prosthetic component as shown in Fig. 1 and further where an insert is shown in Fig. 27, an insert interfacing with a tibial prosthetic component is shown in Figs 31 and 33, and a femoral component isn’t shown but stated as interfacing the combined insert and tibial prosthetic component in [0228]) comprising:
a first implant coupled to a first bone of a joint (Fig. 1, [0063], [0065] femoral prosthetic component 104, [0216]);
a second implant coupled to a second bone of a joint (Fig. 1, [0063], [0065] tibial prosthetic component 106, [0216], Fig. 31, tibial prosthetic component 3100);
further including an insert located between the femoral component and the tibial component ([0228] insert 3116 would be located between the femoral component and the tibial component).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to apply the implant structure of Stein for sensor implant of Nycz as it provides specific implant structure that comprises circuitry for the broadly defined implant of Nycz, enabling standardization of the monitoring implant and consistency of results.
Regarding Claim 5, while Nycz teaches the implant system of claim 2, wherein the transducer includes first and second transducers, each of the first and second transducers disposed in a tibia adjacent a condyle (See Claim 2 Rejection, Fig. 1, the transducers of Nycz includes sensors 120 disposed in a tibia adjacent a condyle), Nycz fails to teach the transducers disposed in an insert.
However Stein teaches an implant system (Figs. 1, 27, 31, and 33, [0187]-[0201], [0216]-[0228] where [0192] teaches a typical knee joint replacement utilizes an insert, a femoral prosthetic component and a tibial prosthetic component as shown in Fig. 1 and further where an insert is shown in Fig. 27, an insert interfacing with a tibial prosthetic component is shown in Figs 31 and 33, and a femoral component isn’t shown but stated as interfacing the combined insert and tibial prosthetic component in [0228]) comprising:
a first implant coupled to a first bone of a joint (Fig. 1, [0063], [0065] femoral prosthetic component 104, [0216]);
a second implant coupled to a second bone of a joint (Fig. 1, [0063], [0065] tibial prosthetic component 106, [0216], Fig. 31, tibial prosthetic component 3100);
further including an insert located between the femoral component and the tibial component ([0228] insert 3116 would be located between the femoral component and the tibial component).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to apply the implant structure of Stein for sensor implant of Nycz as it provides specific implant structure that comprises circuitry for the broadly defined implant of Nycz, enabling standardization of the monitoring implant and consistency of results.
Regarding Claim 6, Nycz and Stein 815 teach the implant system of claim 5, wherein the processor is disposed in the tibial insert (See Claim 5 Rejection, Nycz: [0035] the processor can be part of the implant sensor structure and Stein 815: [0216], [0225] tibial prosthetic component includes electronic circuitry 3110, electronic circuitry 3110 includes a processor).
Regarding Claim 7, Nycz and Stein 815 teach the implant system of claim 6, wherein the processor is configured to wirelessly communicate the vibration signature with the external source (See Claim 6 Rejection, [0034] sensor 121, i.e. acoustic transducers 122, can wirelessly communicate the data with an external source / external device 200 by a telemetry circuit 124, [0023]-[0025], [0029] where the data is representative of a vibration signature that may be analyzed against baseline vibration signatures).
Regarding Claim 8, Nycz and Stein 815 teach the implant system of claim 7, and Nycz teaches wherein the wireless communication is a Bluetooth communication ([0031]).
Regarding Claim 9, while Nycz teaches the implant system of claim 1, and Nycz teaches converting the sensor signal to an electrical signal ([0038]), Nycz fails to teach the implant system further comprising an analog to digital converter, the converter configured to convert the vibration signal to the vibration signature.
However Stein teaches an implant system (Figs. 1, 27, 31, and 33, [0187]-[0201], [0216]-[0228] where [0192] teaches a typical knee joint replacement utilizes an insert, a femoral prosthetic component and a tibial prosthetic component as shown in Fig. 1 and further where an insert is shown in Fig. 27, an insert interfacing with a tibial prosthetic component is shown in Figs 31 and 33, and a femoral component isn’t shown but stated as interfacing the combined insert and tibial prosthetic component in [0228]) comprising:
a first implant coupled to a first bone of a joint (Fig. 1, [0063], [0065] femoral prosthetic component 104, [0216]);
a second implant coupled to a second bone of a joint (Fig. 1, [0063], [0065] tibial prosthetic component 106, [0216], Fig. 31, tibial prosthetic component 3100);
further comprising an analog to digital converter, the converter configured to received data ([0117] oscillation control for ultrasound waves, [0121] the received ultrasound waves and converter from analog to digital by amplifier 636).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to utilize the analog to digital converter of Stein for sensor data of Nycz as it provides a specific circuit structure that accomplishes the transformation of sensor data to electrical signals as this enables Nycz’s conversion step, standardizes the monitoring implant structure, and corresponding ensures consistency of results. And one could term the analog signals from the sensor as vibration signals and the converter digital signals and vibration signatures as a matter of distinguishing terminology.
Regarding Claim 22, while Nycz teaches a method of monitoring implant position over time (Abstract, Figs. 1, 3, and 6-7, [0021]-[0030], [0036], [0048], [0055]) comprising:
coupling a first implant to a first bone of a joint (Fig. 1, [0021]-[0023], [0025] sensors 120 are implanted at a first bone of a joint, such as a femur 104, [0030] where the sensor may be coupled as part of a larger implant, Fig. 7, [0053] step 352);
coupling a second implant to a second bone of the joint (Fig. 1, [0021]-[0023], [0025] sensors 120 are implanted at a second bone of a joint, such as a tibia 106, [0030] where the sensor may be coupled as part of a larger implant, Fig. 7, [0053] step 352);
measuring a reference movement value at a first time after implantation of the first and second implants ([0023]-[0024] baseline signals identified for monitored changes in the movement of the knee joint with the first and second implants, Fig. 7, [0053] step 354), the reference movement being stored as a baseline in a memory of a processor ([0039]);
measuring a secondary movement value at a second time ([0040]-[0042] signals monitored over time with review by a caretaker for calibration purposes, [0065] signals may also be monitored for alarm conditions, indicating a monitoring of alarm condition over time); and
comparing by the processor the reference movement value to the secondary movement value to determine whether at least one of the first implant and the second implant has moved from an original implanted position ([0040]-[0042], [0065] baseline changes can be used to identify if soft tissue degradation has progressed to an alarm condition), Nycz fails to teach the second implant including an insert contacting the first implant.
However Stein teaches an implant system (Figs. 1, 27, 31, and 33, [0187]-[0201], [0216]-[0228] where [0192] teaches a typical knee joint replacement utilizes an insert, a femoral prosthetic component and a tibial prosthetic component as shown in Fig. 1 and further where an insert is shown in Fig. 27, an insert interfacing with a tibial prosthetic component is shown in Figs 31 and 33, and a femoral component isn’t shown but stated as interfacing the combined insert and tibial prosthetic component in [0228]) comprising:
a first implant coupled to a first bone of a joint (Fig. 1, [0063], [0065] femoral prosthetic component 104, [0216]);
a second implant coupled to a second bone of a joint (Fig. 1, [0063], [0065] tibial prosthetic component 106, [0216], Fig. 31, tibial prosthetic component 3100);
further including an insert located between the femoral component and the tibial component ([0228] insert 3116 would be located between the femoral component and the tibial component).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to apply the implant structure of Stein 815 for sensor implant of Nycz as it provides specific implant structure that comprises circuitry for the broadly defined implant of Nycz, enabling standardization of the monitoring implant and consistency of results.
Regarding Claim 23, Nycz and Stein 815 teach the method of claim 22, further comprising measuring transducer data from a transducer at the first time and at the second time to obtain a first sensor data and a second sensor data respectively (See Claim 22 Rejection, [0192] insert outlined as having sensing components, where sensing components, such as capacitors measuring load, thus Nycz’s transducers may be housed in insert as part of the overall implant),
Regarding Claim 24, Nycz and Stein 815 teach the method of claim 23, wherein the transducer data includes vibration data (See Claim 23 Rejection).
Regarding Claim 25, Nycz and Stein 815 teach the method of claim 24, further comprising creating an alert when a change between a first and second transducer data exceeds a predetermined value ([0039] monitoring changes against a threshold, [0065] alarm output).
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nycz in view of Stein et al (US 2013/0079680) (“Stein 680”).
Regarding Claim 12, while Nycz teaches the implant system of claim 11, and further teaches wherein a change in the vibration signature over time indicates implant grinding or misalignment ([0055]), Nycz fails to teach wherein a change in the vibration signature over time indicates implant subsidence.
However Stein 680 teaches an implanted joint monitor coupled to bone ([0059]-[0060]) where spaced apart units coupled to different bones around a joint use ultrasound to characterize implant function ([0065]-[0067]) where this particular sensing configuration enables the identification of implant subsidence ([0067]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, that the monitored vibration signatures of Nycz further include a vibration signature of subsidence as taught by Stein 680 to similarly increase the monitoring capability of the spaced apart implant sensors of Nycz.
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nycz.
Regarding Claim 14, while Nycz teaches the implant system of claim 1, and Nycz teaches the implant system further comprising
A pre-established spatial requirement between the multiple sensors ([0027] where the sensors also act as the acoustic exciters);
Sensing modalities that provide spatial data ([0059]); and
the sensing element of the system may be utilized for guidance purposes ([0060]), Nycz fails to explicitly teach the use of a guidance system configured to position the acoustic exciter.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to apply the guidance capability of the sensing elements to position the acoustic sensors of Nycz to ensure the desired spatial relationship for monitoring is created for accurate assessments ([0027]). Furthermore, it would be obvious to note that spatial data from accelerometers is already a sensing modality of Nycz and can be the source of the desired spatial data used in the guidance steps.
Claim(s) 15-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nycz in view of Trabish et al (US 2020/0405239) (“Trabish”).
Regarding Claim 15, while Nycz teaches the implant system of claim 14, Nycz fails to teach the wherein the guidance system includes an inertial measurement unit.
However Trabish teaches an orthopedic measuring system (Abstract) utilizing implants around a knee joint, where the positioning of the implants are tracked by inertial measurement units ([0113]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, for the spatial data of Nycz to be data from an inertial measurement unit as taught by Trabish as a simple substitution of one movement sensing unit for another to obtain predictable results of reliably sampled movement data.
Regarding Claim 16, Nycz and Trabish teaches the implant system of claim 15, and Stein 815 teaches wherein the inertial measurement unit is located in the first or second implant (See Claim 14 Rejection, Nycz: Fig. 3, [0036] the electronic components are part of the sensor implant).
Response to Arguments
Applicant’s amendments and arguments filed 7/02/2026 with respect to the claim objections have been fully considered and are persuasive. The objection(s) is/are withdrawn.
Applicant’s amendments and arguments filed 7/02/2026 with respect to the 35 USC 112(b) rejections have been fully considered and are persuasive. The rejection(s) is/are withdrawn.
Applicant’s amendments and arguments filed 7/02/2026 with respect to the 35 USC 101 rejections have been fully considered, but are not persuasive.
Applicant argues on pages 6-7 of the Remarks that the claims are not practically performable in the human mind. A human mind cannot perform the steps of surgical coupling, outputting a vibration signature, etc. Examiner respectfully disagrees with the characterization. Examiner is not stating that the claim as a whole is a mental process, rather the claim is directed to a judicial exception, that judicial exception being a mental process of evaluating the data that is the culmination of the above steps. In claim 21, the invention is directed a monitoring of the system to identify when an abnormal condition arises. It is at this point, where the additional limitations of the surgically implanted components are considered. And as stated previously, these limitations are considered extrasolution activity, necessary to enable a mental processing of the joint characteristics.
Applicant argues on page 7, that the claims are a practical application as they acuquire in vivo vibration and movement data that are otherwise unobtainable without imaging and revision surgery. However the reference of Evans et al (US 2006/0047283) from IDS dated 6/02/2023 by Applicant teaches an orthopedic implant with sensing components that enables vibration monitoring at an implant in relation to joint health. And newly cited primary reference Nycz teaches the same along with the threshold comparison for long term monitoring and alarm purposes. While specific vibration signatures may not be taught by Nycz itself, there is little detail to these signatures in Applicant’s claim to suggest an improvement is captured there. Thus, the improvement argument outlined by Applicant remains unpersuasive.
Applicant argues on page 7 that the coupling, sensing, and outputting step are not insignificant extrasolution activity, but does not provide greater detail as to why. Examiner reaffirms that these are steps that provide the input for the mental process to perform the processing. Likewise, the use of an alert is a generic postsolution and is not recognized as a concrete output as there is no, for example, resulting transformation in the physical state of the system and no claimed change in the treatment of the patient. Such changes would be considered concrete outputs.
Applicant argues on pages 7-8 that the added vibration steps and the added reference movement value being stored as a baseline in a memory of a processor to perform a comparison of implant movement amount to more than the judicial exception. Examiner respectfully disagrees. The vibration steps are necessary to generate the input data for mental processing. The storing of a baseline of data is also a step to facilitate a mental process by providing reference data from which to consider the other monitored vibration signatures. And finally, the comparison is merely a narrowing of what the mental processing steps are. The rejection stands.
Applicant’s amendments and arguments filed 7/02/2026 with respect to the 35 USC 103 rejections have been fully considered and are persuasive. The rejection(s) is/are withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Nycz for independent claims 1 and 17 and Nycz and Stein 815 for independent claim 22.
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 JAIRO H PORTILLO whose telephone number is (571)272-1073. The examiner can normally be reached M-F 9:00 am - 5:15 pm.
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/JAIRO H. PORTILLO/
Examiner
Art Unit 3791
/PUYA AGAHI/Primary Examiner, Art Unit 3791
Prosecution Insights