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Claims 11-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 6/12/2026.
Applicant’s election without traverse of group I, claims 1-10 in the reply filed on 6/12/2026 is acknowledged.
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 1-10 are rejected under 35 U.S.C. 101 because the claimed invention is directed to -non-statutory subject matter. The claim(s) as a whole, considering all claim elements both individually and in combination, do not amount to significantly more than
an abstract idea. A streamlined analysis of claim 1 follows.
Regarding claim 1, the claim recites a method for monitoring a joint implant performance. Thus, the claim is directed to a machine/apparatus, which is one of the statutory
categories of invention. The claim is then analyzed to determine whether it is directed to any judicial exception. The following limitations set forth a judicial exception:
"performing a first joint stress test to measure a baseline joint stability value…performing a second joint stress test to measure a second joint stability value…determining joint stability of the joint by comparing the baseline joint…"
These limitations describe a mathematical calculation. Furthermore, the limitations also describe a mental process as the skilled artisan is capable of performing the recited limitations and making a mental assessment thereafter. Examiner also notes that nothing from the claims suggest that the limitations cannot be practically performed by a human, or using simple pen/paper.
Next, the claim as a whole is analyzed to determine whether any element, or combination of elements, integrates the identified judicial exception into a practical application. For this part of the 101 analysis, the following additional limitations are considered:
"a method for monitoring a joint implant performance, the method comprising the steps of: coupling a first implant to a first bone of a joint, the first implant including at least one magnetic marker; coupling a second implant to a second bone of the joint, the second implant including at least one magnetic sensor to detect a position of the magnetic marker…the baseline joint stability being generated by the at least one magnetic sensor…the second joint stability value being generated by the at least one magnetic sensor…".
These additional limitations do not integrate the judicial exception into a practical
application. Rather, the additional limitations are each recited at a high level of generality such that it amounts to insignificant extra-solution activity, e.g., mere data gathering steps necessary to perform the identified judicial exception do not integrate the claims into a practical application. See MPEP 2106.05(g).
The additional limitations also do not add significantly more to the identified judicial exception because they are recited at a high level of generality. Moreover, Examiner takes official notice that "a magnetic sensor configured to obtain an electrical signal including data associated with baseline joint stability values" is widely- understood, routine, and conventional.
Dependent claims 2-10 also fail to add something more to the abstract independent claims as they merely further limit the abstract idea, recite limitations that do not integrate the claims into a practical application for substantially similar reasons as set forth above, and/or do not recite significantly more than the identified abstract idea for substantially similar reasons as set forth above.
Therefore, claims 1-10 are not patent eligible under 35 USC 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) 1-10 is/are rejected under 35 U.S.C. 102(a(1)) as being anticipated by Lavallee (US 20080319448)
Regarding claims 1-10, Lavallee discloses:
1. A method for monitoring a joint implant performance (Abstract), the method comprising the steps of: coupling a first implant (100) to a first bone (2) of a joint, the first implant including at least one magnetic (“…at least one marker configured to emit, receive, or reflect electromagnetic energy…”) (paragraph 0013, 0036) marker (102 or 112) (paragraph 0040); coupling a second implant (110) to a second bone (4) of the joint, the second implant including at least one magnetic sensor (via 20) (“…at least one marker configured to emit, receive, or reflect electromagnetic energy…”) (paragraph 0013, 0036-0037, 0049) to detect a position of the magnetic (“…at least one marker configured to emit, receive, or reflect electromagnetic energy…”) (paragraph 0013, 0036) marker (102 or 112) (paragraph 0036, 0040); performing a first joint stress test to measure a baseline joint stability value, the baseline joint stability value being generated by the at least one magnetic sensor (via 20) (“…at least one marker configured to emit, receive, or reflect electromagnetic energy…”) (paragraph 0013, 0036, 0049); performing a second joint stress test to measure a second joint stability value, the second joint stability value being generated by the at least one magnetic sensor (paragraph 0054, 0059, 0084-0090), and determining joint stability of the joint by comparing the baseline joint stability value to the second joint stability value (paragraph 0062, 0084-0090, 0103) (paragraphs 0062-0090 discuss various calculations and threshold values used to determine the optimization of a joint implant. By ensuring the optimal implant type, size, and position, joint stability is therefore, also ensured).
2. The method of claim 1, wherein the joint is any of a knee joint, shoulder joint, and hip joint (paragraph 0033-0034).
3. The method of claim 1, wherein the joint is a knee joint, the first implant being a femoral implant and the second implant being a tibial insert (paragraph 0040).
4. The method of claim 3, wherein the first bone is a femur and the second bone is a tibia (paragraph 0040).
5. The method of claim 4, wherein the first joint stress test and second joint stress test is any of a varus-valgus stress test, anterior-posterior drawer stress test and flexion- extension stress test (paragraph 0049, 0084-0090).
6. The method of claim 5, wherein the first joint stress test is performed intra- operatively (paragraph 0018).
7. The method of claim 6, wherein the second joint stress test is performed post- operatively on the implanted joint implant (paragraph 0049, 0084-0090).
8. The method of claim 7, wherein the baseline joint stability value and the second joint stability value are tibiofemoral gaps between the femoral implant and the tibial insert measured by the at least one magnetic (via 20) (“…at least one marker configured to emit, receive, or reflect electromagnetic energy…”) (paragraph 0013, 0036-0037, 0049) sensor (paragraph 0054, 0059).
9. The method of claim 8, wherein a difference between the baseline joint stability value and the second joint stability value below a predetermined threshold indicates a stable joint (paragraphs 0062-0090 discuss various calculations and threshold values that take place to determine the optimal implant type, size, and position and therefore, ensuring joint stability).
10. The method of claim 9, wherein a difference between the baseline joint stability value and the second joint stability value exceeding the predetermined threshold indicates an unstable joint (paragraphs 0062-0090, discuss optimization, calculations for optimization, using colors maps to display optimum optimization (e.g. would yield best stability) and not optimum optimization (e.g. would yield not the best stability).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to YASMEEN S WARSI whose telephone number is (571)272-9942. The examiner can normally be reached Monday-Friday 9 am to 5 pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Alexander Valvis can be reached at 571-272-4233. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/YASMEEN S WARSI/Examiner, Art Unit 3791
/ALEX M VALVIS/Supervisory Patent Examiner, Art Unit 3791
Prosecution Insights