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 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1 and 12 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Anes (US Pub No.: 2016/0310297).
Regarding claim 1, Anes (US Pub No.: 2016/0310297) discloses a method of performing knee arthroplasty (in [0041]), the method comprising: resecting each of a tibia and a femur defining a tibiofemoral joint (in [0041]); inserting a sensor support body (the sensor module in the abstract) carrying at least one force sensor (force sensor in the abstract) into the tibiofemoral joint with both the tibia and the femur resected and measuring a force across the tibiofemoral joint without a prosthetic trial component installed on either of the tibia or the femur to provide a full-gap force measurement (in [0047], the force sensor may be on a trial component or an instrument. As such, a measuring of a force without a trial component is present in [0047]); installing at least one prosthetic trial component on at least one of the tibia and the femur (trial component in [0044], implantation of a trail component in [0041]); and inserting the sensor support body carrying at least one force sensor into the tibiofemoral joint with the at least one prosthetic trial component installed on at least one of the tibia and the femur and measuring the force across the tibiofemoral joint to provide a trialing force measurement (in [0003]-[0004]).
Regarding claim 12, Anes discloses the method of claim 1, further comprising, prior to resecting either of the tibia or the femur defining the tibiofemoral joint, inserting the sensor support body carrying at least one force sensor into the tibiofemoral joint and measuring the force across the tibiofemoral joint to provide an uncut force measurement (insertion of a trail implant without disclosure to a resection in [0003] of Anes).
Claim Rejections - 35 USC § 103
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 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) 2-7, 10-11, 13, and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Anes (US Pub No.: 2016/0310297) in view of Rock (US Pub No.: 2010/0249789).
Regarding claim 2, Anes discloses the method of claim 1. However, Anes does not teach wherein: the at least one force sensor comprises a medial force sensor and a lateral force sensor; measuring the force across the tibiofemoral joint to provide the full-gap force measurement comprises measuring a medial compartment force via the medial force sensor and a lateral compartment force via the lateral force sensor; and measuring the force across the tibiofemoral joint to provide the trialing force measurement comprises measuring the medial compartment force via the medial force sensor and the lateral compartment force via the lateral force sensor.
Instead, Rock (US Pub No.: 2010/0249789) teaches wherein: the at least one force sensor comprises a medial force sensor and a lateral force sensor (medial and lateral joint force sensing in [0070]-[0072]); measuring the force across the tibiofemoral joint to provide the full-gap force measurement comprises measuring a medial compartment force via the medial force sensor and a lateral compartment force via the lateral force sensor (in [0070]-[0072]); and measuring the force across the tibiofemoral joint to provide the trialing force measurement comprises measuring the medial compartment force via the medial force sensor and the lateral compartment force via the lateral force sensor (as the sensors are usable on trial inserts in [0136], the sensing of [0070]-[0072] sense a trail force on a medial and lateral force sensing means). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the medial and lateral sensing of Rock into Anes for the purpose of providing a sensing that is able to determine a medial-lateral balance of a joint force of the patient’s knee joint with a display module to show said force data, as disclosed in the abstract.
Regarding claim 3, Anes in view of Rock teach the method of claim 2. However, Anes does not teach wherein: the medial force sensor comprises a medial anterior force sensor and a medial posterior force sensor; the lateral force sensor comprises a lateral anterior force sensor and a lateral posterior force sensor; measuring the force across the tibiofemoral joint to provide the full-gap force measurement comprises measuring a medial anterior force via the medial anterior force sensor, a medial posterior force via the medial posterior force sensor, a lateral anterior force via the lateral anterior force sensor, and a lateral posterior force via the lateral posterior force sensor; and measuring the force across the tibiofemoral joint to provide the trialing force measurement comprises measuring the medial anterior force via the medial anterior force sensor, the medial posterior force via the medial posterior force sensor, the lateral anterior force via the lateral anterior force sensor, and the lateral posterior force via the lateral posterior force sensor.
Instead, Rock (US Pub No.: 2010/0249789) teaches a medial anterior force sensor and a medial posterior force sensor (sensing a medial-lateral balance in [0008], with a sensor array in [0009] disclosing multiple sensors); the lateral force sensor comprises a lateral anterior force sensor and a lateral posterior force sensor (posterior sensors in [0070], anterior sensors in [0071]); measuring the force across the tibiofemoral joint to provide the full-gap force measurement comprises measuring a medial anterior force via the medial anterior force sensor (in [0070]), a medial posterior force via the medial posterior force sensor, a lateral anterior force via the lateral anterior force sensor (in [0071]), and a lateral posterior force via the lateral posterior force sensor (lateral posterior side placement for a sensor in [0070]); and measuring the force across the tibiofemoral joint to provide the trialing force measurement comprises measuring the medial anterior force via the medial anterior force sensor, the medial posterior force via the medial posterior force sensor, the lateral anterior force via the lateral anterior force sensor, and the lateral posterior force via the lateral posterior force sensor (placement of sensors on a trail insert in [0136], where the sensors will measure said disclosed forces as disclosed in [0070]-[0071]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the medial and lateral sensing of Rock into Anes for the purpose of providing a sensing that is able to determine a medial-lateral balance of a joint force of the patient’s knee joint with a display module to show said force data, as disclosed in the abstract.
Regarding claim 4, Anes in view of Rock teach the method of claim 2, wherein Rock teaches the medial force sensor and the lateral force sensor each comprise a capacitive force sensor (capacitive sensors in [0070] and [0082] in Rock). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the medial and lateral sensing of Rock into Anes for the purpose of providing a sensing that is able to determine a medial-lateral balance of a joint force of the patient’s knee joint with a display module to show said force data, as disclosed in the abstract.
Regarding claim 5, Anes in view of Rock teach the method of claim 2, with Rock further comprising: determining, with one or more processors (in [0096], processors disclosed in Rock), an average medial force based on the medial anterior force measured via the medial anterior force sensor and the medial posterior force measured via the medial posterior force sensor (averaging of sensed force with a control circuit in [0104]); determining, with one or more processors, an average lateral force based on the lateral anterior force measured via the lateral anterior force sensor and the lateral posterior force measured via the lateral posterior force sensor; and displaying via a display of a computing device the average medial force and the average lateral force (average lateral force determination in [0124]-[0125]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the medial and lateral sensing of Rock into Anes for the purpose of providing a sensing that is able to determine a medial-lateral balance of a joint force of the patient’s knee joint with a display module to show said force data, as disclosed in the abstract.
Regarding claim 6, Anes in view of Rock teach the method of claim 2, with Rock further comprising displaying via the display of the computing device an indication of a distribution of the average medial force in an anterior to a posterior direction and an indication of a distribution of the average lateral force in the anterior to the posterior direction (display on the sensor module in the abstract and [0006] of Rock). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the medial and lateral sensing of Rock into Anes for the purpose of providing a sensing that is able to determine a medial-lateral balance of a joint force of the patient’s knee joint with a display module to show said force data, as disclosed in the abstract.
Regarding claim 7, Anes in view of Rock teach the method of claim 1, wherein Rock teaches: measuring the force across the tibiofemoral joint to provide the full-gap force measurement comprises measuring the force across the tibiofemoral joint with the tibiofemoral joint in extension and measuring the force across the tibiofemoral joint with the tibiofemoral joint in flexion (measuring tibia and femoral forces in [0070]-[0072], with a flexion sensing in [0011]), and determining the full-gap force measurement based on measurement of the force across the tibiofemoral joint in extension and flexion (determining force during flexion in [0011], extension in [0131]); and measuring the force across the tibiofemoral joint to provide the trialing force measurement comprises measuring the force across the tibiofemoral joint with the tibiofemoral joint in extension and measuring the force across the tibiofemoral joint with the tibiofemoral joint in flexion (sensor element on a trial femoral component implanted at the knee in [0136]), and determining the trialing measurement based on measurement of the force across the tibiofemoral joint in extension and flexion (determining force during flexion in [0011], extension in [0131], it stands to reason that the sensing in a knee joint will still occur when on the trial tibial or femoral inserts of [0136]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the medial and lateral sensing of Rock into Anes for the purpose of providing a sensing that is able to determine a medial-lateral balance of a joint force of the patient’s knee joint with a display module to show said force data, as disclosed in the abstract.
Regarding claim 10, Anes teach the method of claim 1. However, Anes does not teach prior to resecting each of the tibia and the femur defining the tibiofemoral joint: resecting one but not both of the tibia and the femur defining a tibiofemoral joint; inserting the sensor support body carrying at least one force sensor into the tibiofemoral joint with one but not both of a tibia and a femur resected and measuring the force across the tibiofemoral joint to provide a half-gap force measurement.
Instead, Rock further comprises, prior to resecting each of the tibia and the femur defining the tibiofemoral joint: resecting one but not both of the tibia and the femur defining a tibiofemoral joint (resections of the femur and/or tibia in [0041] implies that only one surface may be resected in some embodiments) ; inserting the sensor support body carrying at least one force sensor into the tibiofemoral joint with one but not both of a tibia and a femur resected and measuring the force across the tibiofemoral joint to provide a half-gap force measurement (in [0041], as the sensor is placed on an acetabular cup trial component, a sensing of a force on one joint is present in [0041]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the medial and lateral sensing of Rock into Anes for the purpose of providing a sensing that is able to determine a medial-lateral balance of a joint force of the patient’s knee joint with a display module to show said force data, as disclosed in the abstract.
Regarding claim 11, Anes in view of Rock teach the method of claim 10, wherein Anes discloses resecting one but not both of the tibia and the femur defining the tibiofemoral joint comprises resecting the tibia (resection of only the tibia present in [0041]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the medial and lateral sensing of Rock into Anes for the purpose of providing a sensing that is able to determine a medial-lateral balance of a joint force of the patient’s knee joint with a display module to show said force data, as disclosed in the abstract.
Regarding claim 13, Anes discloses the method of claim 1, wherein inserting the sensor support body carrying at least one force sensor into the tibiofemoral joint with the at least one prosthetic trial component (trial component in [0003]-[0004]) installed on at least one of the tibia and the femur comprises inserting the sensor support body carrying at least one force sensor into the tibiofemoral joint with a femoral prosthetic trial component installed on the femur but without a tibial prosthetic trial component installed on the tibia (acetabular cup implant in [0055] and figures 5A-5. Femur placement in [0041]). Additionally, Rock does teach that the femur comprises inserting the sensor support body carrying at least one force sensor into the tibiofemoral joint with a femoral prosthetic trial component installed on the femur but without a tibial prosthetic trial component installed on the tibia (sensor on a femur member by itself in [0072]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the medial and lateral sensing of Rock into Anes for the purpose of providing a sensing that is able to determine a medial-lateral balance of a joint force of the patient’s knee joint with a display module to show said force data, as disclosed in the abstract.
Regarding claim 17, Anes disclosed the method of claim 1. However, Anes did not teach wherein inserting the sensor support body carrying at least one force sensor into the tibiofemoral joint with the at least one prosthetic trial component installed on at least one of the tibia and the femur comprises inserting the sensor support body carrying at least one force sensor into the tibiofemoral joint with a femoral prosthetic trial component installed on the femur and a tibial prosthetic trial component installed on the tibia.
Instead, Rock teaches wherein inserting the sensor support body carrying at least one force sensor into the tibiofemoral joint with the at least one prosthetic trial component installed on at least one of the tibia and the femur comprises inserting the sensor support body carrying at least one force sensor into the tibiofemoral joint with a femoral prosthetic trial component installed on the femur and a tibial prosthetic trial component installed on the tibia (in [0072] of Rock). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the medial and lateral sensing of Rock into Anes for the purpose of providing a sensing that is able to determine a medial-lateral balance of a joint force of the patient’s knee joint with a display module to show said force data, as disclosed in the abstract.
Claim(s) 8-9 and 14-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Anes (US Pub No.: 2016/0310297) in view of Rock (US Pub No.: 2010/0249789) and Boothby (US Pub No.: 2024/0366405).
Regarding claim 8, Anes in view of Rock teach the method of claim 1, with Rock further comprising: wherein inserting the sensor support body carrying at least one force sensor into the tibiofemoral joint with both the tibia and the femur resected comprises inserting a joint insertion block defined by the sensor support body (the sensor module body 150 of Rock comprises a force sensor as per [0049], tibial and femoral sensing in [0070]-[0073] and trial insert details in [0136]),
However, Anes in view of Rock does not teach inserting a first sensor cover having a first thickness over the at least one force sensor to position the at least one force sensor between the sensor support body and the first sensor cover, wherein inserting the sensor support body carrying at least one force sensor into the tibiofemoral joint with both the tibia and the femur resected comprises inserting a joint insertion block defined by the sensor support body, the at least one force sensor, and the first sensor cover into the tibiofemoral joint; and replacing the first sensor cover with a second sensor covering having a second thickness to position the at least one force sensor between the sensor support body and the second sensor cover, , the at least one force sensor, and the second sensor cover into the tibiofemoral joint.
Boothby (US Pub No.: 2024/0366405) teaches inserting a first sensor cover having a first thickness over the at least one force sensor (being the cover in [0013] and [0016] that cover a sensor and related antenna) to position the at least one force sensor between the sensor support body and the first sensor cover (the cover of Boothby can be inserted over a sensor, as disclosed in [0013], where the cover will interface with the sensor module body 150 of Rock), the at least one force sensor, and the first sensor cover into the tibiofemoral joint (the device of Boothby is disclosed as being for a knee arthroplasty in [0003]-[0004]); and replacing the first sensor cover with a second sensor covering having a second thickness to position the at least one force sensor between the sensor support body and the second sensor cover (it stands to reason the cover of Boothby may be replaced with a similar cover with different dimensions, the dimensions disclosed in [0115]-[0117]), wherein inserting the sensor support body carrying at least one force sensor into the tibiofemoral joint with the at least one prosthetic trial component installed on at least one of the tibia and the femur both the tibia and the femur resected comprises inserting the joint insertion block defined by the sensor support body, the at least one force sensor, and the second sensor cover into the tibiofemoral joint (the cover of [0115]-[0117] can be implemented on the tibial and femoral sensors on a trial implant as presented in Rock in [0070]-[0072] with trial components in [0136] of Rock). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the cover and alignment means of Boothby into the combination involving Anes for the purpose of providing a cover to house and protect a sensor antenna (in the abstract and [0012]-[0013]) with the alignment means being used for aligning the device when inserted into a patient body (as per [0076] and [0107]).
Regarding claim 9, Anes in view of Rock and Boothby teach the method of claim 8, wherein: Boothby the first thickness is sized effective to configure the joint insertion block with a thickness ranging from 8 mm to 13 mm; and the second thickness is sized effective to configure the joint insertion block with a thickness ranging from 17 mm to 22 mm (as a distance from a proximal cover to a distal end of a cover is 30-40 mm in [0115]-[0117], the cover of Boothby is configured such that a joint insertion block of 8mm-13mm and 17mm-22mm is provided for).
Regarding claim 14, Anes in view of Rock and Boothby teach the method of claim 13, with Rock further comprising wherein inserting the sensor support body carrying at least one force sensor into the tibiofemoral joint with the at least one prosthetic trial component installed on at least one of the tibia and the femur both the tibia and the femur resected comprises inserting the joint insertion block defined by the sensor support body (the sensor module body 150 of Rock comprises a force sensor as per [0049], tibial and femoral sensing in [0070]-[0073] and trial insert details in [0136]), further comprising: inserting a sensor cover over the at least one force sensor to position the at least one force sensor between the sensor support body and the sensor cover, at least one of the sensor support body and the sensor cover defining an alignment feature, wherein inserting the sensor support body carrying at least one force sensor into the tibiofemoral joint with the at least one prosthetic trial component installed on at least one of the tibia and the femur both the tibia and the femur resected comprises inserting the joint insertion block defined by the sensor support body, the at least one force sensor, and the sensor cover into the tibiofemoral joint; guiding an instrument to make an alignment indication on at least one of the tibia and the femur using the alignment feature; and subsequently installing the tibial prosthetic trial component on the tibia in alignment with the alignment indication.
Instead, Boothby teaches inserting a sensor cover over the at least one force sensor to position the at least one force sensor between the sensor support body and the sensor cover (being the cover in [0013] and [0016] that cover a sensor and related antenna), at least one of the sensor support body and the sensor cover defining an alignment feature (alignment feature in [0107] of Boothby. Said alignment feature can be incorporated onto the device of Anes in view of Rock. It also stands to reason that the alignment feature will be defined on the cover of Boothby as Boothby’s cover will interface with the alignment means), the at least one force sensor, and the sensor cover into the tibiofemoral joint; guiding an instrument (being the handling instrument in [0017] of Anes that is used to insert the device of Anes. Should the cover of Boothby be incorporated in Anes, said instrument inserts the cover as well) to make an alignment indication on at least one of the tibia and the femur using the alignment feature (via alignment features 155 in Anes in [0050]); and subsequently installing the tibial prosthetic trial component on the tibia in alignment with the alignment indication (disclosed in [0050] of Anes).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the cover and alignment means of Boothby into the combination involving Anes for the purpose of providing a cover to house and protect a sensor antenna (in the abstract and [0012]-[0013]) with the alignment means being used for aligning the device when inserted into a patient body (as per [0076] and [0107]).
Regarding claim 15, Anes in view of Rock and Boothby teach the method of claim 14, wherein Boothby teaches the alignment feature comprise a first alignment feature on a medial side of at least one of the sensor support body and the sensor cover and a second alignment feature on a lateral side of at least one of the sensor support body and the sensor cover (in Boothby, the alignment features 4027 wrap around the device of figures 13 and 14A. said arrangement of the alignment features can be incorporated into the implant of Anes in view of Rock).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the cover and alignment means of Boothby into the combination involving Anes for the purpose of providing a cover to house and protect a sensor antenna (in the abstract and [0012]-[0013]) with the alignment means being used for aligning the device when inserted into a patient body (as per [0076] and [0107]).
Regarding claim 16, Anes in view of Rock and Boothby teach the method of claim 14, wherein the alignment feature comprises an angular intersection between two surfaces (angular alignment features 4027 disclosed in figure 13 of Boothby).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the cover and alignment means of Boothby into the combination involving Anes for the purpose of providing a cover to house and protect a sensor antenna (in the abstract and [0012]-[0013]) with the alignment means being used for aligning the device when inserted into a patient body (as per [0076] and [0107]).
Claim(s) 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Anes (US Pub No.: 2016/0310297) in view of Fisher (US Pub No.: 2010/0217156).
Regarding claim 18, Anes discloses the method of claim 1, wherein: the sensor support body is inserted into the tibiofemoral joint (the sensor module in the abstract, tibia implant in [0035]), and inserting the sensor support body carrying at least one force sensor into the tibiofemoral joint with both the tibia and the femur resected (resection details in [0041]) comprises inserting the sensor support body carrying at least one force sensor into the tibiofemoral joint (in [0041]); and inserting the sensor support body carrying at least one force sensor into the tibiofemoral joint with the at least one prosthetic trial component (trial component details in [0041]) installed on at least one of the tibia and the femur comprises inserting the sensor support body carrying at least one force sensor into the tibiofemoral joint with the at least one prosthetic trial component installed on at least one of the tibia and the femur (in [0041]).
Instead, Fisher (US Pub No.: 2010/0217156) teaches a stop configured to limit a depth to which the sensor support body is inserted into the tibiofemoral joint (part 140B In figure 1F, defined as a stop in [0049]-[0050], used to stop a movement of a sensor too far into a knee in [0059]) until the depth stop contacts the tibia (stopping by tibia in [0059], interfacing with a condylar surface in [0050]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the stop member of Fisher into Anes for the purpose of providing a means to prevent a sensor “from being advanced too far into the knee” as per [0059] of Fisher.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Instead, Fisher (US Pub No.: 2005/0177170) considered for a medial and lateral force sensing of a knee in the abstract. Gustilo (US Patent No.: 5,733,292) teaches a trail implant with stop elements shown in figure 1 as part 90.
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/AREN PATEL/Examiner, Art Unit 3774
/JERRAH EDWARDS/Supervisory Patent Examiner, Art Unit 3774