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 Claims
Claims 1-8, 10, 12, 13, 15, 17, and 19-25 are pending in the present application with claims 1 and 24 being independent, as set forth in the Preliminary Amendment dated January 22, 2025.
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 1-8, 10, 12, 13, 15, 17, and 19-23 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.
Regarding claim 1, the phrase "for example" (line 2) renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d). For purposes of examination, the Examiner will assume the limitations following the phrase are not required as being part of the claimed invention.
Claim 1 recites the limitation "the power supply" in line 10. There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 10, the phrase "optionally" (line 3) renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d). For purposes of examination, the Examiner will assume the limitations following the phrase are not required as being part of the claimed invention.
Claim 15 recites the limitation "the loading region" in line 3. There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 15, the phrase "optionally" (line 4) renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d). For purposes of examination, the Examiner will assume the limitations following the phrase are not required as being part of the claimed invention.
Claim 17 recites the limitation "the recess" in line 3. There is insufficient antecedent basis for this limitation in the claim.
While claim 17 recites how the recess extends through the insert at an acute angle to the normal axis (where the normal axis is relative to the planar structure), it appears that the recess actually extends through the insert at a normal angle to the normal axis or in other words parallel to the planar surface (e.g., see Figures 4A-4B of the present application). It appears that Applicant may want to focus on defining such features regarding an opening to the recess.
Claims 2-8, 10, 12, 13, 15, 17, and 19-23 are rejected based on their dependency from claim 1.
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.
Claims 1-3, 7, 8, 10, 13, 15, 19, and 20 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by U.S. Patent App. Pub. No. 2021/0378841 to Mokete ("Mokete"):
Regarding claim 1, Mokete discloses an implantable device (implantable electronic device 12 in Figures 1, 3) for monitoring an intra-articular joint environment corresponding to a joint body, for example a bone or a prosthetic joint component ([0041]-[0042] disclose how the implantable device 12 includes an accelerometer to measure acceleration/rotation of at least a part of endoprosthesis 11 that forms a knee joint/joint body along with femur/tibia per Figure 2), the implantable device comprising:
a sensor module configured to measure data indicative of at least one parameter of an intra-articular joint environment corresponding to a joint body (electromechanical motion sensor/accelerometer 13 per [0019], [0041]);
a communications unit operatively coupled to the sensor module and configured to transmit the measured data to an external device (wireless communication module 14 transmits measured data to remote device 18 per Figure 1 and [0041], [0044], [0046]); and
a rechargeable battery configured to power the sensor module and the communications unit (rechargeable battery 16 per Figure 1 and [0041]),
wherein the sensor module, the power supply and the communications unit are contained within a capsule (casing 26 (capsule) houses the accelerometer/sensor module, battery 16 (power supply), and communication module 14 per [0049]),
wherein the capsule is releasably mountable within an opening of the joint body (casing 26 of electronic device 12 is removable mounted within cavity 35 (opening) of prosthesis 11 (joint body) per Figure 3 and [0049]), and
wherein, when the capsule is releasably mounted within the opening of the joint body, the sensor module is configured to monitor the at least one parameter of the intra- articular joint environment (motion of the prosthesis/joint body 11 is monitored by the electromechanical motion sensor/accelerometer when the casing 26 is removably mounted in cavity/opening 35 per Figure 3, [0041], [0042], [0049]).
Regarding claim 2, Mokete discloses an implantable device according to claim 1, further including wherein the sensor module comprises one or more of: a motion sensor, a temperature sensor, a force sensor and a chemical sensor for measuring the at least one parameter (electromechanical motion sensor/accelerometer 13 per [0019], [0041]).
Regarding claim 3, Mokete discloses an implantable device according to claim 1, further including a non-volatile memory configured to store patient data thereon (memory 15 stores recorded measurements/readings per [0041], [0046).
Regarding claim 7, Mokete discloses an implantable device according to claim 1, further including wherein the sensor module, power supply and communications unit are embedded within the capsule (casing 26 (capsule) houses the accelerometer/sensor module, battery 16 (power supply), and communication module 14 per [0049]).
Regarding claim 8, Mokete discloses an implantable device according to claim 1, further including wherein the communications unit is adapted to transmit the measured data in response to receiving a user input ([0046] discloses how recorded data can be downloaded to remote device 18 during a visit to a medical practitioner which would require some "user input" from such medical practitioner; also, [0041] discloses how the remote device 18 can wirelessly interrogate the implantable device 12 to glean recordings/measurements which again would involve some user input), or wherein the capsule is releasably mountable to the joint body by a press-fit connection with the opening of the joint body ([0044], [0049] and Figure 3 disclose/illustrate how the casing/capsule 26 of the implantable device 12 is removably mountable to the prosthesis/joint body 11 by pressing it into the cavity/opening 35 of the prosthesis/joint body 11).
Regarding claim 10, Mokete discloses an implantable device according to claim 1, further including an insert (tibial component 11.2 and plate 37 are an "insert") for use with a prosthetic joint component (femoral component 11.1 are a "prosthetic joint component"), wherein the capsule is releasably mounted to the insert, optionally wherein the capsule is mounted to the insert by a press-fit connection (casing/capsule 26 is releasably mounted to plate 37 of insert by press-fit connection per Figure 3 and [0042]).
Regarding claim 13, Mokete discloses an implantable device according to claim 10, further including wherein the insert comprises a recess for receiving the capsule (cavity/recess 35.2 of insert/plate 37), or wherein the insert comprises a non-loading region adjacent a loading-region, and wherein the recess is formed in the non-loading region.
Regarding claim 15, Mokete discloses an implantable device according to claim 10, further including wherein the insert comprises an articular surface (see top of tibial component 11.2 in Figure 3 and Figures 4A-4B) configured to engage a corresponding articular surface of a second joint or an implant body (see bottom of femoral component 11.1 in Figure 3 and Figures 4A-4B), and wherein the loading region is part of the articular surface (see how articular surface receives load of second joint/femoral component 11.1 in Figures 4A), optionally wherein the insert comprises a second articular surface spaced from the first articulating surface, wherein the second articular surface is configured to engage a corresponding second articular surface of the second joint body or implant body defining the joint environment, and wherein the non-loading region is disposed between the first and second articular surfaces.
Regarding claim 19, Mokete discloses an implantable device according to claim 10, further including wherein the insert is adapted for use with any of: a replacement ankle joint, a replacement knee joint, a replacement hip joint, a replacement wrist joint, a replacement elbow joint or a replacement shoulder joint (see replacement knee joint of Figure 4A).
Regarding claim 20, Mokete discloses an implantable device according to claim 1, further including a receiver circuit for receiving power wirelessly from a charging module outside the intra-articular environment and configured to charge the rechargeable battery ([0041] discloses a receiving circuit f or coupling with an external inductive charger to charge the rechargeable battery 16).
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.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent App. Pub. No. 2021/0378841 to Mokete ("Mokete") in view of U.S. Patent App. Pub. No. 2021/0366610 to Gross et al. ("Gross"):
Regarding claim 4, Mokete discloses an implantable device according to claim 1, but appears to be silent regarding a support frame for mounting the sensor module in a pre-determined position within the capsule.
Nevertheless, Gross teaches ([0327]) that it was known in the healthcare informatics art for an implantable device (e.g., part of a knee prosthesis per [0329]) to include a PCB (support frame) on which sensors (e.g., strain gauges per [0290]) can be mounted (which would be a "pre-determined" position after mounting because the determination on where to mount the sensors would have to be made at the time of mounting) and to be enclosed within an outer casing/capsule which advantageously provides a space-efficient assembly for a medical implant.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention for the implantable device of Mokete to include a support frame for mounting the sensor module in a pre-determined position within the capsule as taught by Gross to advantageously provides a space-efficient assembly for a medical implant. A person of ordinary skill in the art would have been motivated to combine the prior art to achieve the claimed invention and there would have been a reasonable expectation of success in doing so. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007). Furthermore, all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. Id.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent App. Pub. No. 2021/0378841 to Mokete ("Mokete") in view of U.S. Patent App. Pub. No. 2019/0076083 to Goodchild et al. ("Goodchild"):
Regarding claim 5, Mokete discloses an implantable device according to claim 1, but appears to be silent regarding wherein the sensor module comprises a plurality of strain gauges configured to measure a force applied to the capsule from the joint body.
Nevertheless, Goodchild teaches ([0045], [0140]-[0141], Figure 12) that it was known in the healthcare informatics art for a measurement device 180 of insert 170 configured to attach to a tibial prosthetic component to include a sensor module including a plurality of load sensors/strain gauges 402-414 which would measure a load applied to the measurement device from femoral component to advantageously support installation of prosthetic components to ensure optimal loading, balance, and alignment that improves performance/reliability ([0094]) and improve future prosthetic components ([0038]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention for the sensor module of Mokete to include a plurality of strain gauges configured to measure a force applied to the capsule from the joint body as taught by Goodchild to advantageously support installation of prosthetic components to ensure optimal loading, balance, and alignment that improves performance/reliability and improve future prosthetic components.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent App. Pub. No. 2021/0378841 to Mokete ("Mokete") in view of U.S. Patent App. Pub. No. 2013/0079668 to Stein et al. ("Stein"):
Regarding claim 12, Mokete discloses an implantable device according to claim 10, but appears to be silent regarding wherein the insert comprises a polymer material.
Nevertheless, Stein teaches ([0035], Figures 1-3 and 12) that it was known in the healthcare informatics art for an insert used as part of a knee replacement to be made of a variety of materials including metal, plastic, or polymer material of sufficient strength.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention for the insert of Mokete to include a polymer material as taught by Stein because a person of ordinary skill in the art would have been motivated to combine the prior art to achieve the claimed invention and there would have been a reasonable expectation of success in doing so. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007). The courts have made clear that the teaching, suggestion, or motivation test is flexible and an explicit suggestion to combine the prior art is not necessary. The motivation to combine may be implicit and may be found in the knowledge of one of ordinary skill in the art, or, in some cases, from the nature of the problem to be solved. DyStar Textilfarben GmbH & Co. Deutschland KG v. C.H. Patrick Co., 464 F.3d 1356, 1360, 80 USPQ2d 1641, 1645 (Fed. Cir. 2006). Furthermore, all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007).
Allowable Subject Matter
Claims 24-25 are allowed.
The following is an examiner’s statement of reasons for allowance:
Regarding claim 24, the prior art did not disclose a method of wirelessly powering an implantable device having a Bluetooth Low Energy communications unit using a charging module, wherein the charging module is configured to power the implantable device according to a first transmission scheme using one or more charging coils, the method comprising: receiving a data packet comprising a localization parameter of an implantable device, the data packet being received by a charging module from a Bluetooth Low Energy communications unit of the implantable device, adapting the first transmission scheme to a second transmission scheme based on the localization parameter, and operating the charging module according to the second transmission scheme to induce charge in the implantable device. Claim 25 is allowed based on its dependency from claim 24.
Claims 6, 17, and 21 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include 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:
Regarding claim 6, neither Mokete nor the other prior art further disclosed a support frame for mounting the sensor module in a pre-determined position within the capsule, wherein the sensor module comprises a plurality of strain gauges configured to measure a force applied to the capsule from the joint body, wherein the support frame comprises a central region extending along a longitudinal axis of the capsule, and wherein the plurality of strain gauges are at least partially disposed either side of the central region.
Regarding claim 17, neither Mokete nor the other prior art further disclosed the insert to include a substantially planar structure defining a normal axis, and wherein the recess extends through the insert at an acute angle relative to the normal axis, or wherein the insert comprises a hemi-spherical portion, and wherein the recess is formed in an inferior aspect of the insert.
Regarding claim 21, neither Mokete nor the other prior art further disclosed a charging module for powering an implantable device, wherein the communications unit comprises a Bluetooth Low Energy module configured to transmit the measured data in a data packet comprising the measured data and a localization parameter of the device, the charging module comprising: a receiver unit configured to receive the data packet; a charging coil configured to generate a magnetic field for wirelessly transferring power to the rechargeable battery of the implantable device, and a controller operatively coupled to the charging coil and the receiver unit, wherein the controller is configured to operate the charging coil according to a first transmission scheme, wherein the controller is configured to adapt the first transmission scheme based on the localization parameter to provide a second transmission scheme, and wherein the controller is configured to operate the charging coil according to the second transmission scheme.
Reasons for indicating allowable subject matter for claims 22-23 are the same as those for claim 21 based on their dependency.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. The references cited on the attached PTO-892 disclose various types of implantable devices for monitoring data indicative of intra-articular joint environments as well as various types of charging arrangements including charging modules that wirelessly induce a charge in mobile electronic devices via conductive coils and Bluetooth communications therebetween.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JONATHON A. SZUMNY whose telephone number is (303) 297-4376. The examiner can normally be reached Monday-Friday 7-5.
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/JONATHON A. SZUMNY/Primary Examiner, Art Unit 3686
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