DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-15, in the reply filed on May 8th, 2026 is acknowledged.
Claims 16-22 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 May 8th, 2026.
Information Disclosure Statement
The information disclosure statement filed on 5/11/2023 fails to comply with 37 CFR 1.98(a)(2), which requires a legible copy of each cited foreign patent document; each non-patent literature publication or that portion which caused it to be listed; and all other information or that portion which caused it to be listed. It has been placed in the application file, but the information referred to therein has not been considered.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: “138” & “140” in figs. 5A-5B; “502” & “504” & “510” in fig. 15; “1314” in fig. 26; “2306” in fig. 44; “2406” & “2410” in fig. 45. Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The disclosure is objected to because of the following informalities:
“trackers 6910 are in association with one or more sensors of brace 6910” in para. [0145] should recite “trackers 6910 are in association with one or more sensors of brace 6810”.
Appropriate correction is required.
Claim Objections
Claim 1 is objected to because of the following informalities:
Claim 1 line 4 “a wearable for the joint” should recite “a wearable configured to be worn on the joint”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-15 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 line 6 (claims 2-15 by virtue of dependency) recites the limitation "the second magnet". There is insufficient antecedent basis for this limitation in the claim. The limitation is suggested to recite “the second tracker”.
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.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claims 1-15 are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101). Claim 1 lines 2-3 (Claims 2-15 by virtue of dependency) recites the limitations "a first tracker attached to a first bone of a joint" and "a second tracker attached to a second bone of the joint", Claim 12 line 2 (Claims 13-14 by virtue of dependency) “... attached to a femur ... attached to a tibia”, and Claim 13 line 2 (claim 14 by virtue of dependency) recites “... attached to the femur ... attached to the tibia”. Because the claimed limitations positively recite a part of the human body, they are directed to nonstatutory subject matter.
It is recommended that applicant amend the claimed language to “a first tracker configured to be attached to a first bone of a joint”, “a second tracker configured to be attached to a second bone of the joint”, “configured to be attached to a femur ... configured to be attached to a tibia”, and “configured to be attached to the femur ... configured to be attached to the tibia”.
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.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims are 1-3, 6-8, 10, 12, and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Disilvestro (US 20050010301 A1) in view of Sherman (US 20070167703 A1).
Regarding claim 1, Disilvestro discloses a kinematic tracking system (“joint endoprosthesis system”, Abstract, para. [0017, 0094-0096], fig. 24) comprising: a first tracker (superparamagnet 26, fig. 24, para. [0058, 0095]) attached to a first bone (“distal end of a femur 12”; “one signal source associated with the implant or bone on one side of the joint space”, para. [0056, 0058, 0094-0095], as seen in fig. 24) of a joint (as seen in fig. 24, “knee”, para. [0042], “joint comprises the knee”, claim 36); a second tracker (superparamagnet 26', fig. 24, para. [0094-0095]) attached to a second bone of the joint (“proximal end of a tibia 14”; “other signal source associated with the implant or bone on the opposite side of the joint space ... superparamagnet 26' in the tibial component 18”, para. [0042, 0056, 0094-0095], as seen in fig. 24); and a wearable for the joint (cuff 150, fig. 24, para. [0094-0095]) having first and second sensors (“Multiple sensors 28, 28', 28", 28'"”; “Hall effect sensors 28, 28', 28", 28'" ... carried by the cuff”, para. [0094-0096]), the first sensor and second sensor detecting a magnetic field of the tracker (“sense the magnitude of the flux density generated by a permanent magnet at a particular location”; “characteristics of the magnetic fields sensed for a particular patient ... voltages produced by the Hall effect sensors or transducers into a usable distance or for characterizing the magnetic field(s)”, para. [050-0052, 0055, 0059, 0095-0098]).
Disilvestro does not expressly disclose the first sensor detecting a first magnetic field of the first tracker and the second sensor detecting a second magnetic field of the second magnet.
However, Sherman directed to a method for determining a position of a magnetic source discloses the first sensor detecting a first magnetic field of the first tracker (“magnetic sensor array 604 ... located in the magnetic field generated by a first magnet 450 ... only to measure the magnetic field of the respective magnets 450 and transmit such measurement values to the controller 302”, para. [0186-0187, 0190-0192]) and the second sensor detecting a second magnetic field of the second magnet (“second magnetic sensor array 606 ... located in the magnetic field generated by a second magnet 450 ... only to measure the magnetic field of the respective magnets 450 and transmit such measurement values to the controller 302”, para. [0186-0187, 0190-0192]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Disilvestro such that the first sensor detects a first magnetic field of the first tracker and the second sensor detects a second magnetic field of the second magnet, in view of the teachings of Sherman, as this would aid in determining the position of the relevant bony anatomy of the patient (Sherman, para. [0186-0187, 0190-0192]).
Regarding claim 2, Disilvestro, as modified by Sherman hereinabove, discloses the kinematic tracking system of claim 1, wherein the first tracker includes a first magnet (“magnet”, “superparamagnet 26”, Abstract, para. [0049-0050, 0058, 0094-0095]).
Regarding claim 3, Disilvestro, as modified by Sherman hereinabove, discloses the kinematic tracking system of claim 2, wherein the second tracker includes a second7 magnet (“magnet”, “superparamagnet 26’”, Abstract, para. [0049-0050, 0058, 0094-0095])).
Regarding claim 6, Disilvestro, as modified by Sherman hereinabove, discloses the kinematic tracking system of claim 3, wherein the first and second trackers are bone attachment members (“signal source 26 could be supplied as a separate discrete component to be affixed to the patient's bone”, para. [0076, 0094, 0112], as seen in figs. 4 & 24).
Regarding claim 7, Disilvestro, as modified by Sherman hereinabove, discloses the kinematic tracking system of claim 6. Disilvestro, as modified by Sherman hereinabove, does not expressly disclose wherein the bone attachment members are threaded shafts.
However, Sherman directed to method for determining a position of a magnetic source discloses wherein the bone attachment members are threaded shafts (“magnet(s) 450 which embody the magnetic source 390 ... coupled to the bone ... threaded screw portion 464”, para. [0115], fig. 31).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Disilvestro, as modified by Sherman hereinabove, such that the bone attachment members are threaded shafts, in view of the teachings of Sherman, as this would aid in securing the magnets to the bone such that the magnets do not move or otherwise propagate.
Regarding claim 8, Disilvestro, as modified by Sherman hereinabove, discloses the kinematic tracking system of claim 1, wherein the first and second sensors are Hall sensors (“Hall effect sensors”, para. [0095-0096]).
Regarding claim 10, Disilvestro, as modified by Sherman hereinabove, discloses the kinematic tracking system of claim 9, wherein the joint is a knee joint (as seen in fig. 24, “knee”, para. [0042], “joint comprises the knee”, claim 36).
Regarding claim 12, Disilvestro, as modified by Sherman hereinabove, discloses the kinematic tracking system of claim 1, wherein the joint is a knee joint and the first tracker is attached to a femur and the second tracker is attached to a tibia.
Regarding claim 15, Disilvestro, as modified by Sherman hereinabove, discloses the kinematic tracking system of claim 1. Disilvestro, as modified by Sherman hereinabove, does not expressly disclose wherein the first sensor detects a position of the first tracker via the first magnetic field and the second sensor detects a position of the second tracker via the second magnetic field.
However, Sherman directed to a method for determining a position of a magnetic source discloses the first sensor detects a position of the first tracker via the first magnetic field (“magnetic sensor array 604 ... located in the magnetic field generated by a first magnet 450 ... only to measure the magnetic field of the respective magnets 450 ... position of the magnetic source 309 ... determined”, para. [0186-0187, 0190-0192]) and the second sensor detects a position of the second tracker via the second magnetic field (“second magnetic sensor array 606 ... only to measure the magnetic field of the respective magnets 450 ... position of the magnetic source 309 ... determined”, para. [0186-0187, 0190-0192]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Disilvestro, as modified by Sherman hereinabove, such that the first sensor detects a position of the first tracker via the first magnetic field and the second sensor detects a position of the second tracker via the second magnetic field., in view of the teachings of Sherman, as this would aid in determining the position of the relevant bony anatomy of the patient (Sherman, para. [0186-0187, 0190-0192]).
Claims 4-5, 9, and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Disilvestro in view of Sherman, as applied to claim 3 above, and further in view of Coleman (US 20160213924 A1).
Regarding claim 4, Disilvestro, as modified by Sherman hereinabove, discloses the kinematic tracking system of claim 3. Disilvestro, as modified by Sherman hereinabove, does not expressly disclose wherein the wearable is a brace.
However, Coleman directed to a brace assembly discloses a wearable (“brace assembly”, Abstract), wherein the wearable is a brace (knee brace 100, fig. 1A). Coleman further discloses that the knee brace 100 can comprise systems and methods for determining positional data of any component or portion of the brace system, sensors can be integrated with the brace 100 by integrating into an internal portion of the brace 100, and that the sensors can comprise at least one Hall effect sensor (para. [0115-0116]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Disilvestro, as modified by Sherman hereinabove, such that the wearable is a brace, in view of the teachings of Coleman, as such a modification would have been merely a substitution of the cuff of Disilvestro for the knee brace of Coleman and would aid in coupling/integrating the Hall effect sensors for determining positional data.
Regarding claim 5, Disilvestro, as modified by Sherman hereinabove, discloses the kinematic tracking system of claim 3. Disilvestro, as modified by Sherman hereinabove, does not disclose wherein the wearable includes first and second portions, the first portion being located adjacent the first bone and the second portion being located adjacent the second bone.
However, Coleman directed to a brace assembly discloses a wearable (“brace assembly”, Abstract), wherein the wearable (knee brace 100, para. [0115]) includes first and second portions (stay 105 & stay 110, fig. 2A, para. [0115]), the first portion being located adjacent the first bone (stay 105 as seen in fig. 1A, para. [0115]) and the second portion being located adjacent the second bone (stay 110 as seen in fig. 1A, para. [0115]). Coleman further discloses that the knee brace 100 can comprise systems and methods for determining positional data of any component or portion of the brace system, sensors can be integrated with the brace 100 by integrating into an internal portion of the brace 100, and that the sensors can comprise at least one Hall effect sensor (para. [0115-0116]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Disilvestro, as modified by Sherman hereinabove, such that the wearable includes first and second portions, the first portion being located adjacent the first bone and the second portion being located adjacent the second bone, in view of the teachings of Coleman, as such a modification would have been merely a substitution of the cuff of Disilvestro for the knee brace of Coleman and would aid in coupling/integrating the Hall effect sensors for determining positional data.
Regarding claim 9, Disilvestro, as modified by Sherman and Coleman hereinabove, discloses the kinematic tracking system of claim 4. Disilvestro, as modified by Sherman and Coleman hereinabove, does not expressly disclose wherein the brace includes first and second portions connected by a hinge mechanism.
However, Coleman directed to a brace assembly discloses wherein the brace includes first (stay 105, fig. 1A) and second portions (stay 110, fig. 1A) connected by a hinge mechanism (pivot region 115, para. [0115], fig. 1A).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Disilvestro, as modified by Sherman and Coleman hereinabove, such that the brace includes first and second portions connected by a hinge mechanism, in view of the teachings of Coleman, as such a modification would have been merely a substitution of the cuff of Disilvestro for the knee brace of Coleman such that the brace includes two sets of geometry and the first set of geometry can be free to move with respect to the second set of geometry pivoting and/or moving about the pivot region.
Regarding claim 11, Disilvestro, as modified by Sherman and Coleman hereinabove, discloses the kinematic tracking system of claim 10, wherein the brace includes inner spaces for receiving the first and second sensors (unlabeled, but as seen in fig. 24, “Hall effect sensors 28, 28', 28", 28'" could be carried by the cuff”, para. [0096] & Coleman, para. [0115]).
Claim 13-14 is rejected under 35 U.S.C. 103 as being unpatentable over Disilvestro in view of Sherman and Coleman, as applied to claim 9 above, and further in view of Yellen (US 20070276218 A1)
Regarding claim 13, Disilvestro, as modified by Sherman and Coleman hereinabove, discloses the kinematic tracking system of claim 12. Disilvestro further discloses that greater sensitivity of the overall system can be achieved with optimized software and redundancy of multi-dimensional sensors using multiple signal sources (para. [0093]).
Disilvestro, as modified by Sherman and Coleman hereinabove, does not expressly disclose the system further including third and fifth trackers attached to the femur and fourth and sixth tackers attached on the tibia.
However, Yellen directed to magnetic imaging for position and orientation sensing of implanted devices discloses a first tracker attached to a first bone (magnets 40, fig. 3; “femoral liner 12 (attached to the end of the femor) ... magnets 40 affixed”, para. [0013-0014]) and second tracker attached to a second bone (magnets 40, fig. 4, “tibial tray 14 (attached to the end of the tibia 22) ... has three magnets 50 affixed”, para. [0013-0014]), and third and fifth trackers attached to the femur (“Three magnets 40 are affixed to the femoral liner 12”, para. [0014, 0016-0017], magnets 40 as seen in fig. 3) and fourth and sixth tackers attached on the tibia (tibial tray 14 has three magnets 50 affixed to it”, para. [0014, 0016-0017], magnets 50 as seen in fig. 4).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Disilvestro, as modified by Sherman and Coleman hereinabove, such that the system further includes third and fifth trackers attached to the femur and fourth and sixth tackers attached on the tibia, in view of the teachings of Yellen, as this would aid in determining the relative positions and orientations of the tibial tray and femoral liner (para. [0014]) and would aid in providing a greater sensitivity of the overall system.
Regarding claim 14, Disilvestro, as modified by Sherman and Coleman hereinabove, discloses the kinematic tracking system of claim 13, further a third sensor for detecting movement of the third tracker, a fourth sensor for detecting movement of the fourth tracker (“four Hall effect sensors”, para. [0096]). Disilvestro further discloses that it may be desirable to provide a plurality of sensors as part of a kit or endoprosthesis system to measure distances in different parts of the joint and that greater sensitivity of the overall system can be achieved with optimized software and redundancy of multi-dimensional sensors using multiple signal sources and that the sensors are three-dimensional Hall effect sensors (para. [0077, 0093]).
Disilvestro, as modified by Sherman and Coleman hereinabove, does not expressly disclose a fifth sensor for detecting movement of the fifth tracker and a sixth sensor for detecting movement of the sixth tracker.
However, Yellen directed to magnetic imaging for position and orientation sensing of implanted devices discloses a first sensor, a second sensor, a third sensor for detecting movement of the third tracker, a fourth sensor for detecting movement of the fourth tracker, a fifth sensor for detecting movement of the fifth tracker and a sixth sensor for detecting movement of the sixth tracker (“array of magnetic sensors”; “three dimensional positions of the magnets 40, 50 are determined by measuring the magnetic field at each magnetic sensor 30 in an array of magnetic sensors”; “array of n sensors 30i (I=1-n) ... number of sensors ... equal to the number of degrees of freedom for each magnet”; “Each sensor observes a field”, para. [0009, 0015, 0022-0023] (Examiner note: the 18 single-axis sensors of Yellen would be functionally equivalent to providing 6 three-dimensional Hall effect sensors of Disilvestro to sense 18 degrees of freedom from six magnets with three degrees of freedom)). Yellen further discloses that the magnetic sensors 30 may be arranged in a magnetic brace (not shown) in the shape of a cylinder surrounding the implant and for six magnets with three degrees of freedom at least 18 single-axis sensors 30 are required (para. [0009).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Disilvestro, as modified by Sherman and Coleman hereinabove, such that the system further includes a third sensor for detecting movement of the third tracker, a fourth sensor for detecting movement of the fourth tracker, a fifth sensor for detecting movement of the fifth tracker and a sixth sensor for detecting movement of the sixth tracker, in view of the teachings of Yellen, as this would aid in determining the relative positions and orientations of the tibial tray and femoral liner (para. [0014]) by measuring distances in different parts of the joint and would aid in providing a greater sensitivity of the overall system.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: Qu (US 20170231533 A1) directed to a joint analysis system for analyzing kinematics of an anatomical including a sensor device, a storage device, a magnet, and an analysis engine; Obma (US 20160242646 A1) directed to wearable sensing devices/brace 10 facilitating the monitoring of physical and physiological parameters in humans (Abstract, para. [0076], fig. 1).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANDREW ELI HOFFPAUIR whose telephone number is (571)272-4522. The examiner can normally be reached Monday-Friday 8:00-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Charles Marmor II can be reached at (571) 272-4730. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/A.E.H./Examiner, Art Unit 3791
/AURELIE H TU/Primary Examiner, Art Unit 3791
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