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
The applicant’s confirmation of the election of group III, claims 13-20, in response to the restriction requirement in the non-final rejection mailed on 2/25/2026 is acknowledged.
Claim Interpretation
The amendments to the claims filed in the response on 5/26/2026 do not change the examiner’s previous position that the instant limitations do not invoke a 35 USC 112(f) interpretation.
Response to Amendment
The applicant’s amendments filed on 5/26/2026 have been entered into the record on file. The status of the claims are as follows:
claims 1-12 have been cancelled
independent claim 13 is amended to recite additional limitations
claims 21 and 22 were added as new claims introducing new limitations
Response to Arguments
Applicant’s amendments and arguments/remarks with respect to claims 13-20 have been fully considered and overcome the previously held 35 USC 103 rejections; but are moot in view of the new grounds of rejection provided in the 35 USC 103 rejection below. Specifically, the examiner is adding the Trabish et al (US 2020/0405219 A1) reference to the 103 rejection in addition to the Johannaber and Splieth references in order to teach the newly amended limitations as outlined in the rejection below.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 13-22 are rejected under 35 U.S.C. 103 as being unpatentable over Johannaber et al (US 2018/0161168 A1) in view of Splieth et al (US 2012/0259334 A1) and Trabish et al (US 2020/0405219 A1).
Johannaber discloses a method of monitoring one or more characteristics of a patient (element 1200; figure 12), the method comprising:
preparing a bone for insertion of a trial prosthesis (step 1202; paragraphs [0144]-[0148]; figure 12)
implanting a sensing device (implant sensors, elements 1106a-n; figures 1-4 and 11) within a medullary canal of the bone (wherein examiner notes that a medullary canal is present in order to insert stem of humeral component [elements 102, 202, 302, or 402] of trial implant into humerus; step 1204; paragraphs [0060]-[0094] and [0144]-[0148]; figures 1-4 and 12);
operating the sensing device during a trialing of a joint of the patient while sensing device is implanted within the medullary canal to generate data regarding the one or more characteristics of the patient (step 1206; paragraphs [0144]-[0148]; figure 12); and
whereby the generated data is communicated from the sensing device (element 1100; figure 12) to a remote computing device (user interface; element 1104) external of the patient (wherein data from sensors 1106a-1106n are transmitted via controller element 1102 via wireless signal to user interface such as computing device outside the body; steps 1208-1210; paragraphs [0142]-[0148]; figures 11-13).
However, Johannaber does not explicitly disclose that the preparing the bone for insertion comprises reaming a medullary canal of a bone; or that the sensing device includes an inertial-based sensor.
Splieth teaches a trial implant having a stem for orthopedic surgery wherein the trial implant is inserted into a canal (element 202) which has been reamed into a bone (reamer is used to form opening for trial prosthesis), such as the humerus (element 200; paragraphs [0028], [0042]-[0043]) wherein the trial implant stem (distal portion, element 14) includes anchoring features (arm elements 20 and 22 having textured outside surface elements 28 and 29 for engaging with the bone to prevent rotational and axial movement of the trial implant; paragraphs [0031]-[0037]; figures 2, 3, 5, 6, 8-10, 12 and 13).
Trabish teaches an orthopedic system for pre-operative, intra-operative and post-operative assessment of the implants which includes utilizing inertial based sensors (IMU in implants) to measure position and motion experiences by the implants pre, intra and post-surgery and further teaches performing range of motion tests intra-operatively in order to ensure proper installation (paragraph [0058]-[0059], [0063], [0070]-[0071] and [0112]).
Regarding claims 13-20; Johannaber teaches preparing the bone for a humeral trial implant having a humeral stem. Splieth teaches forming a medullary canal in the humerus for receiving a trial implant having a stem. Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify Johannaber method for monitoring one or more characteristics of a patient such that the preparing step includes reaming a medullary canal of a bone as taught by Splieth in order to prepare to receive Johannaber’s trial implant stem in the humerus.
Furthermore regarding claims 13-20; Johannaber teaches the use of additional sensors (proximity sensor and displacement sensor) to provide additional information regarding implantation of the implant (paragraphs [0141]-[0143], and [0147]; figures 11, 13). Trabish teaches utilizing inertial sensors in an implant in pre-operative and intra-operative situation in order to measure position and motions experienced by the implant during implantation and to determine range of motion of the joint by moving the joint through range of motion tests during implantation (paragraph [0058]-[0059], [0063], [0070]-[0071] and [0112]). Therefore it would have been obvious to one of ordinary skill in the art at the time of filing to further modify the Johannaber/Splieth combination to further include an inertial-based sensor in Johannaber’s sensing device as taught by Trabish in order to monitor position and motion of the implants in the body pre-, intra- and post-operatively.
Further regarding claims 14 and 15; the Johannaber/Splieth/Trabish combination as described above discloses inserting the humeral component on the trial implant into the medullary canal; however, the Johannaber/Splieth/Trabish combination is silent to anchoring the sensing device within medullary canal using one of one or more anchoring features.
Splieth further teaches providing the stem of a trial implant with one or more anchoring features (elements formed by grooves on outer surfaces, elements 28 and 29, of stem arm, elements 20 and 22) to anchor and prevent rotational and axial movement of a trial implant in the medullary canal of a humeral bone (paragraphs [0031]-[0037]; figures 2, 3, 5, 6, 8-10, 12 and 13).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to further modify the Johannaber/Splieth/Trabish combination to include anchoring features on the stem of the humeral component in order to anchor the trial implant in the bone and prevent rotation and axial movement of the implant during the trialing of the bone.
Further regarding claim 15; Splieth teaches the one or more anchoring features comprise a plurality of fins spaced around a circumference of the sensing device (wherein features formed by intersecting grooves, element 42, are formed circumferentially on outer surface, elements 28 and 29; paragraphs [0031]-[0037]; figures 2, 3, 5, 6, 8-10, 12 and 13). Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing that the Johannaber/Splieth/Trabish combination as described above would also include a plurality fins spaced around a circumference of the stem as taught by Splieth in order to anchor the trial implant in the bone.
Further regarding claim 16; the Johannaber/Splieth/Trabish combination is described in the rejection of claims 14 and 15 above. Splieth further teaches extending one or more anchoring features to abut against the bone within the medullary canal to anchor the stem implant within the medullary canal (wherein arm elements 20 and 22 are radially extended to engage the anchoring features of the textured outer surface elements 28 and 29 against the inner surface of the medullary canal; paragraphs [0031]-[0037], specifically [0035]; figures 2, 3, 5, 6, 8-10, 12 and 13).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to further modify the Johannaber/Splieth/Trabish combination to extend one or more anchoring features to abut against the bone within the medullary canal to answer the sensing device within the medullary canal as taught by Splieth in order to prevent rotational and axial movement of the trial implant in the bone.
Further regarding claim 17 and 18; the Johannaber/Splieth/Trabish combination is described in the rejection of claim 16 above. Splieth further teaches anchoring the anchoring features (arm elements 20 and 22 having anchoring features formed on outer surfaces 28 and 29) of the stem within the medullary canal using a tool (driver, element 32) coupled to the trial implant (paragraphs [0031]-[0037], specifically [0035]; figures 2, 3, 5, 6, 8-10, 12 and 13).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing that the Johannaber/Splieth/Trabish combination as described above would also include a tool coupled to the sensing device to anchor the trial implant within the bone in order to prevent rotation and axial movement of the implant during trialing.
Further regarding claim 18; the Johannaber/Splieth/Trabish combination is described in the rejection of claim 17 above. Splieth further teaches the anchoring the stem within the medullary canal using the tool (driver element 32) includes actuating with the tool (element 32) a component (arm elements 20 and 22) of the trial implant stem to extend one or more anchoring features (textured outer surface elements 28 and 29) against the bone within the medullary canal; paragraphs [0031]-[0037], specifically [0035]; figures 2, 3, 5, 6, 8-10, 12 and 13).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing that the Johannaber/Splieth/Trabish combination as described in the rejections above would also utilize a tool for actuating the components of the sensing device to extend the one or more anchoring features against the bone within the medullary canal as taught by Splieth in order to prevent rotational and axial movement of the sensing trial implant during trialing of the implant.
Further regarding claim 19; Johannaber further teaches removing the sensing device from the medullary canal after the trialing of the joint is complete and prior to resection of the bone of the patient (discloses removing trial components before completing the surgical procedure; paragraph [0145]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing that the Johannaber/Splieth/Trabish combination would also comprise removing the sensing device from the medullary canal after the trialing of the joint is complete and prior to resection of the bone of the patient.
Further regarding claim 20; the Johannaber/Splieth/Trabish combination as described in the rejection of claim 19 teaches withdrawing the sensing device from the medullary canal after trialing of the joint is complete. Splieth teaches the trial implant is removed after the implant position is properly established/sized by retracting the one or more anchoring features from contact with the bone within the medullary canal (wherein the drive tool, element 35, is used to actuate movement of the arms, elements 20 and 22, from the expanded position to a retracted position; paragraph [0051]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to remove the sensing device of the Johannaber/Splieth/Trabish combination by retracting the one or more anchoring features from contact with the bone within the medullary canal as taught by Splieth.
Further regarding claims 21 and 22; the Johannaber/Splieth/Trabish combination is described in the rejection of claim 13 above. Trabish further teaches operating a sensing device with an inertial-based sensor intra-opertaively while performing a range of motion of the joint in order to ensure proper range of motion is provided by the implants (paragraph [0058]-[0059], [0063], [0070]-[0071] and [0112]). Therefore it would have been obvious to one of ordinary skill in the art at the time of filing to operate the sensing device of the Johannaber/Splieth/Trabish combination while trialing the joints to perform a range of motion as taught by Trabish in order to ensure that proper range of motion is provided by the implants intra-operatively.
Further regarding claim 22; Trabish teaches communicating the range of motion to a remote system during/after the range of motion test. Therefore it would have been obvious to one of ordinary skill in the art at the time of filing for the Johannaber/Splieth/Trabish combination would communicate the generated data from the sensing includes communicating the range of motion of the joint so that the user can ensure proper range of motion before closing after surgery.
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 ADAM J EISEMAN whose telephone number is (571)270-3818. The examiner can normally be reached Monday - Friday (7:00 AM - 4:00 PM).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jacqueline Cheng can be reached at 571-272-5596. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ADAM J EISEMAN/ Primary Examiner, Art Unit 3791
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