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 .
Status of the Claims
This Office Action is responsive to the amendment filed May 11, 2026. As directed by the amendment: Claims 8, 11, and 12 have been amended. Claims 5 and 6 have been cancelled. Claims 21 and 22 are newly added. Claims 1-4 and 7-22 are presently pending in this application.
Examiner’s Note
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.
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.
Claim(s) 1-4, 7-10, 13-15, and 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Delport (US 2019/0209079) in view of West et al. (US 2013/0211279), herein referred to as West.
Regarding claim 1, Delport discloses a ligament tension analysis device (101) (figure 11) for monitoring ligament tension of a patient's knee joint (¶122, ¶129), the ligament tension analysis device (101) comprising a first set of probes (102+120, 103+107), wherein each probe of the first set of probes (102+120, 103+107) is configured to (i.e. capable of) be coupled with a first ligament (112) of the patient's knee joint (¶246), a first sensor (121) coupled to the first set of probes (102+120, 103+107) and configured to (i.e. capable of) produce first data of the first ligament of the patient (¶248), a display (¶29), and an analysis circuit (122) (¶246) configured to (i.e. capable of) determine first tension data of the first ligament (112) of the patient based on the first data and display the first tension data on the display (¶29), wherein the first tension data is indicative of an amount of tension of the first ligament of the patient (¶245-¶253).
Yet, Delport’s lacks the first sensor is a conductance sensor.
However, West teaches a conductance sensor (220) (figure 6 and ¶28).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute Delport’s sensor (e.g. Hall sensor) with a conductance sensor as taught by West, since such a modification is a mere substitution of one known sensor for another to yield predictable results.
Thus, the modified Delport’s ligament tension analysis device has a first conductance sensor (220 of West) and configured to (i.e. capable of) produce first conductance data (¶28 of West) indicative of a conductance of the first ligament (112 of Delport) of the patient.
Regarding claim 2, the modified Delport’s ligament tension analysis device has wherein to determine the first tension data of the first ligament of the patient's knee joint comprises to determine a first set of tension data values across a range of degrees of flexion of the patient's knee joint (¶252 of Delport), wherein each tension value of the first set of tension data values is indicative of an amount of tension of the first ligament (112 of Delport) at a corresponding degree of flexion of the patient's knee joint (¶252 of Delport), and to display the first tension data on the display comprises to display a tension-versus-flexion graph having a graph curve indicative of the first set of tension data values across the range of degrees of flexion of the patient's knee joint (¶252 of Delport).
Regarding claim 3, the modified Delport’s ligament tension analysis device discloses all the features/elements as claimed but lacks further comprising a second set of probes, wherein each probe of the second set of probes is configured to be coupled with a second ligament of the patient's knee joint, and a second conductance sensor coupled to the second set of probes and configured to produce second conductance data indicative of a conductance of the second ligament of the patient, wherein the analysis circuit is further configured to determine second tension data for the second ligament of the patient based on the second conductance data and display the second tension data on the display along with the first tension data, wherein the second tension data is indicative of an amount of tension of the second ligament of the patient.
However, it is known that mere duplication of the essential working parts of a device involves only routine skill in the art.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide the modified Delport’s ligament tension analysis device with a second set of probes, wherein each probe of the second set of probes is configured to be coupled with a second ligament of the patient's knee joint, and a second conductance sensor coupled to the second set of probes and configured to produce second conductance data indicative of a conductance of the second ligament of the patient, wherein the analysis circuit is further configured to determine second tension data for the second ligament of the patient based on the second conductance data and display the second tension data on the display along with the first tension data, wherein the second tension data is indicative of an amount of tension of the second ligament of the patient, since such a modification is a mere duplication of the essential working parts of a device that involves only routine skill in the art. Furthermore, having first and second sets of probes would monitor the medial collateral ligament (MCL) and the lateral collateral ligament (LCL) of a patient.
Regarding claim 4, the modified Delport’s ligament tension analysis device discloses all the features/elements as claimed including wherein to determine the first tension data of the first ligament of the patient comprises to determine a first set of tension data values across a range of degrees of flexion of the patient's knee joint (¶252 of Delport), wherein each tension value of the first set of tension data values is indicative of an amount of tension of the first ligament (112 of Delport) at a corresponding degree of flexion of the patient's knee joint (¶252 of Delport), and to display the first tension data on the display comprises to display a tension-versus-flexion graph having a graph curve indicative of the first set of tension data values across the range of degrees of flexion of the patient's knee joint (¶252 of Delport). Yet, the modified Delport’s ligament tension analysis device lacks to determine the second tension data of the second ligament of the patient's knee joint comprises to determine a second set of tension data values across the range of degrees of flexion of the patient's knee joint, wherein each tension value of the second set of tension data values is indicative of an amount of tension of the second ligament at a corresponding degree of flexion of the patient's knee joint, and to display the second tension data on the display comprises to display a tension-versus-flexion graph having a second graph curve indicative of the second set of tension data values across the range of degrees of flexion of the patient's knee joint.
However, it is known that mere duplication of the essential working steps of a device involves only routine skill in the art.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide the modified Delport’s ligament tension analysis device with determining the second tension data of the second ligament of the patient's knee joint comprises determining a second set of tension data values across the range of degrees of flexion of the patient's knee joint, wherein each tension value of the second set of tension data values is indicative of an amount of tension of the second ligament at a corresponding degree of flexion of the patient's knee joint, and to display the second tension data on the display comprises to display a tension-versus-flexion graph having a second graph curve indicative of the second set of tension data values across the range of degrees of flexion of the patient's knee joint, since such a modification is a mere duplication of the essential working steps of a device that involves only routine skill in the art. Furthermore, having first and second sets of probes would monitor the medial collateral ligament (MCL) and the lateral collateral ligament (LCL) of a patient.
Regarding claim 7, the modified Delport’s ligament tension analysis device has wherein the first ligament is a lateral collateral ligament of the patient's knee joint (e.g. LCL, ¶122 of Delport), the first conductance sensor (220 of West) is configured to (i.e. capable of) produce first conductance data indicative of a conductance of the lateral collateral ligament of the patient's knee joint, and the analysis circuit (122 of Delport) is configured to (i.e. capable of) determine first tension data of the lateral collateral ligament of the patient's knee joint based on the first conductance data (via element 220 of West), wherein the first tension data is indicative of an amount of tension of the lateral collateral ligament of the patient (¶252 of Delport).
Regarding claim 8, the modified Delport’s ligament tension analysis device discloses all the features/elements as claimed but lacks further comprising a second set of probes, wherein each probe of the second set of probes is configured to be coupled with a medial collateral ligament of the patient's knee joint, and a second conductance sensor coupled to the second set of probes and configured to produce second conductance data indicative of a conductance of the medial collateral ligament of the patient, wherein the analysis circuit is further configured to determine second tension data for the medial collateral ligament of the patient based on the second conductance data and display the first tension data and the second tension data on the display, wherein the second tension data is indicative of an amount of tension of the medial collateral ligament of the patient.
However, it is known that mere duplication of the essential working parts of a device involves only routine skill in the art.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide the modified Delport’s ligament tension analysis device with a second set of probes, wherein each probe of the second set of probes is configured to be coupled with a medial collateral ligament of the patient's knee joint, and a second conductance sensor coupled to the second set of probes and configured to produce second conductance data indicative of a conductance of the medial collateral ligament of the patient, wherein the analysis circuit is further configured to determine second tension data for the medial collateral ligament of the patient based on the second conductance data and display the first tension data and the second tension data on the display, wherein the second tension data is indicative of an amount of tension of the medial collateral ligament of the patient, since such a modification is a mere duplication of the essential working parts/steps of a device that involves only routine skill in the art. Furthermore, having first and second sets of probes would monitor the medial collateral ligament (MCL) and the lateral collateral ligament (LCL) of a patient.
Regarding claim 9, the modified Delport’s ligament tension analysis device has wherein each probe of the first set of probes (102+120, 103+107 of Delport) includes an electrical lead (figure 11 of Delport) and an electrical coupler (106, 113 of Delport) connected to the corresponding electrical lead (figure 11 of Delport), wherein the electrical coupler (106, 113 of Delport) is configured to (i.e. capable of) be coupled with the first ligament (112 of Delport) of the patient's knee joint.
Regarding claim 10, the modified Delport’s ligament tension analysis device has wherein the first conductance sensor (220 of West) is located in the electrical coupler (113 of Delport) (figure 11 of Delport).
Regarding claim 13, the modified Delport’s ligament tension analysis device has wherein the conductance sensor (220 of West) is configured to (i.e. capable of) generate a voltage across the first set of probes (102+120, 103+107 of Delport) and measure a resulting current using the first set of probes (102+120, 103+107 of Delport).
Regarding claim 14, the modified Delport’s ligament tension analysis device has wherein conductance sensor (220 of West) is configured to (i.e. capable of) generate a voltage of five volts across the first set of probes.
Regarding claim 15, the modified Delport’s ligament tension analysis device has wherein the conductance sensor (220 of West) is configured to (i.e. capable of) determine the first conductance data based on the measured resulting current (¶28 of West).
Regarding claim 21, the modified Delport’s ligament tension analysis device has wherein a distal end of each probe (102+120, 103+107 of Delport) is configured to (i.e. capable of) directly contact the first ligament (considered functional).
Claim(s) 16-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Delport and West as applied to claim 1 above, and further in view of Fisher et al. (US 8,211,041), herein referred to as Fisher.
Regarding claim 16, the modified Delport’s ligament tension analysis device discloses all the features/elements as claimed but lacks further comprising a flexion sensor configured to produce flexion data indicative of a present degree of flexion of the patient's knee joint, wherein the analysis circuit is configured to determine the first tension data relative to the present degree of flexion of the patient' knee joint.
However, Fisher teaches a flexion sensor (100) configured to (i.e. capable of) produce flexion data indicative of a present degree of flexion of the patient's knee joint (col. 12, ll. 56-60).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide the modified Delport’s ligament tension analysis device with a flexion sensor configured to produce flexion data indicative of a present degree of flexion of the patient's knee joint as taught by Fisher, since such a modification would provide the surgeon with flexion data.
Thus, the modified Delport’s ligament tension analysis device has wherein the analysis circuit (122 of Delport) is configured to (i.e. capable of) determine the first tension data relative to the present degree of flexion of the patient' knee joint.
Regarding claim 17, the modified Delport’s ligament tension analysis device has wherein to determine the first tension data of the first ligament of the patient's knee joint comprises to determine a set of tension data values across a range of degrees of flexion of the patient's knee joint based on the flexion data (via flexion sensor of Fisher), wherein each tension value of the set of tension data values is indicative of an amount of tension of the first ligament (112 of Delport) at a corresponding degree of flexion of the patient's knee joint (¶252 of Delport).
Regarding claim 18, the modified Delport’s ligament tension analysis device has wherein to display the first tension data on the display (¶29 of Delport) comprises to display a tension-versus-flexion graph having a graph curve indicative of the first set of tension data values across the range of degrees of flexion of the patient's knee joint (¶252 of Delport).
Claim(s) 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Delport, West, Fisher as applied to claims above, and further in view of Ellis et al. (US 2007/0135735), herein referred to as Ellis.
Regarding claim 19, the modified Delport’s ligament tension analysis device discloses all the features/elements as claimed but lacks wherein the flexion sensor comprises an optical sensor.
However, Ellis teaches force sensors may be optical fiber flexion sensors (¶40).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide the modified Delport’s ligament tension analysis device having the flexion sensor with wherein the flexion sensor comprises an optical sensor as taught by Ellis, since such a modification would provide a specific type of sensor.
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Delport and West as applied to claim 1 above, and further in view of Metzger et al. (US 2007/0244488), herein referred to as Metzger.
Regarding claim 20, the modified Delport’s ligament tension analysis device discloses all the features/elements as claimed but lacks wherein the analysis circuit is located within a ligament balancer device.
However, Metzger teaches an analysis circuit (¶37) is located within a ligament balancer device (¶2 and figures 4 and 5).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified Delport’s ligament tension analysis device with wherein the analysis circuit is located within a ligament balancer device as taught by Metzger, since such a modification would detect and measure distraction forces (¶37).
Allowable Subject Matter
Claims 11 and 12 are allowed.
Claim 22 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: After further search and consideration it is determined that the prior art of record neither anticipated nor renders obvious the claimed subject matter of the instant application as a whole either taken alone or in combination, in particular, the prior art of record does not teach, the following limitation(s) in combination with the remaining claimed limitation such as but not limited to “wherein each electrical coupler includes a plug connected to the corresponding electrical lead and a terminal extending from the plug and configured to be coupled to a ligament coupler”, “wherein each electrical coupler includes a plug connected to the corresponding electrical lead and a connection needle extending from the plug and configured to be inserted into the first ligament of the patient's knee joint”.
Response to Arguments
Applicant's arguments filed May 11, 2026 have been fully considered but they are not persuasive.
Applicant’s arguments on pages 11-15, under 35 U.S.C. 103, of the Remarks are directed to the combination of references (Delport in view of West). Applicant argues that “such a modification would not have been obvious to one of ordinary skill in the art. A Hall sensor and a conductance sensor are not simple substitutions for one another. Each of these sensors detect fundamentally different physical properties and are used for different purposes. Hall sensors measure magnetic fields associated with positional or motion sensing, while conductance sensors generate a voltage across two points to measure electrical conductance of materials. These sensors operate according to different physical principles, measure different parameters, require different signal acquisition architectures, and provide different information to the overall system. In other words, a sensor that measures conductance would be unable to measure position or motion. Clearly, a sensor for measuring conductance does not have the ability to function as a sensor that measures motion”. However, the Examiner respectfully disagrees because the Examiner substituted one sensor (e.g. Hall sensor) for another (e.g. conductance sensor) to yield predictable results. The Examiner notes that a conductance sensor would measure/sense conductance, thus providing a different information to the user. The reference Delport does not preclude such a sensor cannot be used. Furthermore, even if the sensors work according to different principles, that wouldn't preclude them from being used in similar applications.
Applicant further argues “Even further, as noted above, the slider module 103 and the ligament-attaching element 106 of Delport are glued to the ligament. It is unclear if such glue is even compatible with conductance sensing. It is plausible that such glue destroys electrical conductivity and acts as an electrical insulator. Even if such glue was compatible, a sensor for conductance sensing would not be compatible with a device that receives inputs related to motion or position”. Applicant's arguments fail to comply with 37 CFR 1.111(b) because they amount to a general allegation that the claims define a patentable invention without specifically pointing out how the language of the claims patentably distinguishes them from the references.
Lastly, applicant argues “if a proposal for modifying the prior art in an effort to attain the claimed invention causes the art to become inoperable or destroys its intended function, then the requisite motivation to make the modification would not have existed. See MPEP Section 2143(V). Removing the Hall sensor of Delport destroys the basic operating principles of Delport - using relative motion between two components to determine a strain parameter. Thus, it would not have been obvious to one of ordinary skill in the art to make such a modification.” However, the Examiner respectfully disagrees that such a modification would destroy the invention as these are considered mere allegations. The reference Delport does not preclude a conductance sensor cannot be used.
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.
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/SI MING KU/Primary Examiner, Art Unit 3775
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