DETAILED ACTION
The following is a non-final office action is response to communications received on 02/13/2023. Claims 1-20 are currently pending and addressed below.
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 § 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 1-20 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 recites the limitations “a first Implant coupled to a first bone” and “a second implant coupled to a second bone.” 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 Implant configured to be coupled to a first bone” and “a second implant configured to be coupled to a second bone.”
Claims 15 & 19 are similarly rejected.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-3, 9, 11-14, 19 & 20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Disilvestro (US 7,347,874).
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Regarding Claim 1, Disilvestro teaches a joint implant (10) comprising:
a first implant (24) coupled to a first bone (12) of a joint, the first implant including at least one marker (26);
a second implant (16) coupled to a second bone (14) of the joint and contacting the first implant (Fig 1), the second implant including:
at least one marker reader (28) to detect a position of the marker to identify positional data of the first implant with respect to the second implant (Col 8: lines 6-27), and
at least one load sensor (28C) to measure load data between the first and second implants (Col 16: lines 35-57); and
a processor (36) operatively coupled to the marker reader and the load sensor, wherein the processor outputs the positional data and the load data to an external source (Col 9: line 66 – Col 10: line 2).
Regarding Claim 2, Disilvestro teaches wherein the marker (26) is a magnet (Col 7: lines 40-41) and the marker reader (28) is a magnetic sensor (Col 7: lines 56-59).
Regarding Claim 3, Disilvestro teaches wherein the magnetic sensor is a Hall sensor assembly including at least one Hall sensor (Col 7: lines 56-65).
Regarding Claim 9, Disilvestro teaches wherein the magnetic sensor is coupled to the load sensor by a connecting element (i.e., the circuitry connections illustrated in Fig 4).
Regarding Claim 11, Disilvestro teaches wherein the joint is a knee joint, the first implant is a femoral implant and the second implant is a tibial implant (Fig 1).
Regarding Claim 12, Disilvestro teaches wherein the tibial implant includes a tibial insert (Fig 1; dashed line structure in the tibia) and a tibial stem (16 & 18), the marker reader and the processor being disposed within the tibial insert.
Regarding Claim 13, Disilvestro teaches wherein the positional data includes any of a knee flexion angle, knee varus-valgus rotation, knee internal-external rotation, knee medial-lateral translation, superior-inferior translation, anterior-posterior translation, and time derivatives thereof (Fig 5).
Regarding Claim 14, Disilvestro teaches wherein the tibial insert includes any of a pH sensor, a temperature sensor and a pressure sensor (28C) operatively coupled to the processor.
Regarding Claim 19, Disilvestro teaches the device as set forth in the rejection of claim 1. Further, Disilvestro teaches wherein the implant comprises at least one inertial measurement unit (combination of marker 26 and marker reader 28) to measure a motion data (Fig 5) of the second implant, and a processor (36) operatively coupled to inertial measurement unit, wherein the processor outputs the motion data to an external source (Col 9: line 66 – Col 10: line 2).
Regarding Claim 20, Disilvestro teaches as set forth supra in the rejection of claims 2 & 3.
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) 15, 17 & 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Disilvestro (US 7,347,874) in view of Wasielewski et al. (US 8,956,418).
Regarding Claim 15, as set forth in the rejection of claim 1, Disilvestro discloses the invention substantially as claimed. However, Disilvestro does not disclose:
wherein the first implant includes: a plurality of medial markers located on a medial side of the first implant, and a plurality of lateral markers located on a lateral side of the first implant; and
wherein the second implant includes: at least one medial marker reader to identify a position of the medial markers and at least one lateral marker reader to identify a position of the lateral markers, the position of the medial markers and the position of the lateral markers providing a positional data of the first implant with respect to the second implant,
a medial load sensor to measure medial load data between the first and second implants on a medial side of the joint implant,
a lateral load sensor to measure lateral load data between the first and second implants on a lateral side of the joint implant, and
wherein the processor is operatively coupled to the medial marker reader, the lateral marker reader, the medial load sensor and the lateral load sensor, wherein the processor simultaneously outputs the positional data, the medial load data and the lateral load data to an external source.
Wasielewski teaches a smart joint implant with sensors in the same field of endeavor. Said implant comprises a first femoral implant (16) and second tibial implant (12) having both medial and lateral markers (36 & 52) and marker readers in order to measure pressure and mechanical markers within the implant (Col 4: lines 8-10). Essentially, Wasielewski teaches the duality of the sensor system between both medial and lateral sides.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to construct the device and associated electronics, as taught by Disilvestro, in the dual manner as taught by Wasielewski in order to more effectively monitor the implant parameters as a whole (i.e., both medial and lateral sides). As Disilvestro teaches the claimed structure and functions, adding like structures to either side of the articulating implant, as taught by Wasielewski, would allow for more detailed and comprehensive monitoring.
Regarding Claim 17, the combination teaches wherein the medial and the lateral markers (26) include magnets (Disilvestro Col 7: lines 40-41) located at discrete locations on the first implant.
Regarding Claim 18, the combination teaches wherein the medial and the lateral marker readers include Hall sensor assemblies with at least one Hall sensor (Disilvestro Col 7: lines 56-65).
Allowable Subject Matter
Claims 4-8, 10 & 16 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.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIAN AINSLEY DUKERT whose telephone number is (571)270-3258. The examiner can normally be reached Mon-Fri 6am-4pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melanie Tyson can be reached at (571)272-9062. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRIAN A DUKERT/Primary Examiner, Art Unit 3774