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 .
Election/Restrictions
Applicant’s election without traverse of claims 1-11 in the reply filed on May 4, 2026 is acknowledged.
Claims 11-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 4, 2026.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims.
Claim 9 recites that a plurality of sensors includes a temperature sensor, a pressure sensor, and a pH sensor; each of the sensors required by the claim and located as required the claim (see dependency to claim 3 and sensor placement) are not depicted in combination in any of Applicant’s figures.
Therefore, the claimed subject matter must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) 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. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. 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.
Claim Objections
Claim 9 is objected to because of the following informalities:
“plurality of sensors include” should read as “plurality of sensors includes”
Appropriate correction is required.
Claim Rejections - 35 USC § 102
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.
Claims 1-6 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by:
Stein et al. (US 20160089079 A1) (disclosed by Applicant) (hereinafter – Stein).
Re. Claim 1: Stein teaches a knee implant (Title; Abstract)
comprising:
a femoral implant configured to be coupled to a femur (Fig. 1: femoral prosthetic component 104);
a tibial implant configured to be coupled to a tibia (Fig. 1: tibial prosthetic component 106), and
a tibial insert disposed between the femoral implant and the tibial implant (Paragraph 0069: “The insert is fitted between femoral prosthetic component 104 and tibial prosthetic component 106”),
the tibial insert (Fig. 27: tibial insert 2700)
comprising (refer to annotated Fig. 27 below for the following claim limitations – Examiner notes that one or more “regions” identified may extend through each layer):
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wherein the medial central region and the lateral central region are defined by solid volumes extending from a proximal surface to a distal surface of the tibial insert (Fig. 27: medial central region and the lateral central region identified above possess are formed by at least some portion comprising a solid material which occupies a three-dimensional volume extending from claimed surfaces).
Re. Claim 2: Stein teaches the invention according to claim 1. Stein further teaches the invention wherein the medial central region and the lateral central region extend from an anterior surface to a posterior surface of the tibial insert (Fig. 27: each region identified extends accordingly).
Re. Claim 3: Stein teaches the invention according to claim 1. Stein further teaches the invention wherein the at least one sensor and the battery are located away from the medial central region and the lateral central region (see annotated Fig. 27).
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Re. Claim 4: Stein teaches the invention according to claim 3. Stein further teaches the invention wherein the at least one sensor and the battery are disposed within the central region
(see annotated Fig. 27 shown in the rejection of claim 3).
Re. Claim 5: Stein teaches the invention according to claim 4. Stein further teaches the invention wherein the at least one sensor and the battery are disposed around a periphery of the tibial insert (see annotated Fig. 27).
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Re. Claim 6: Stein teaches the invention according to claim 3. Stein further teaches the invention wherein the at least one sensor and the battery are disposed around a periphery of the tibial insert (see annotated Fig. 27 in the rejection of claim 5).
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.
Claims 7-10 are rejected under 35 U.S.C. 103 as being unpatentable over:
Stein et al. (US 20160089079 A1) (disclosed by Applicant) (hereinafter – Stein) in view of
DiSilvestro et al. (US 20180235514 A1)(disclosed by Applicant) (hereinafter – DiSilvestro).
Re. Claim 7: Stein teaches the invention according to claim 3, but does not teach the invention wherein the at least one sensor includes a Hall sensors and the femoral implant includes a magnet, the Hall sensor configured to track a location of the magnet.
DiSilvestro teaches analogous art in the technology of implantable orthopedic sensors (Paragraph 0004). DiSilvestro further teaches the invention wherein the at least one sensor includes a Hall sensors and the femoral implant includes a magnet, the Hall sensor configured to track a location of the magnet (Paragraph 0024: “In the exemplary embodiment of FIG. 3, the implanted sensor 50 includes a signal source 52, such as a permanent magnet, that is embedded in the distal femoral component 28, and a sensor 54, such as a Hall effect switch, embedded in the proximal tibial component 22. The associated electronics 56 are also secured to the proximal tibial component 22”).
It would have been obvious to one having skill in the art before the effective filing date to have modified Stein to include the use of Hall sensors in a tibial component and a magnetic component in the femoral component as taught by DiSilvestro, the motivation being that doing so permits the system of Stein identify knee flexion angles occurring beyond a predetermined threshold (Paragraph 0027), and further allows for determination of cycles of use of the patient’s joint to assess wear (Paragraph 0029).
Re. Claim 8: Stein as modified by DiSilvestro teaches the invention according to claim 7. Stein further teaches the invention wherein the at least one sensor including a plurality of sensors, the plurality of sensors including at least one load sensor (Fig. 27: load pads 2722).
Re. Claim 9: Stein as modified by DiSilvestro teaches the invention according to claim 8. The embodiment cited in Stein to teach the requirements of claim 8 does not teach a plurality of sensors comprising each of a temperature sensor, a pressure sensor, and a pH sensor.
However, Stein further teaches such sensors in alternative embodiments, while similarly stating the combined use (conjunction) of more than one sensor type (Paragraph 0191: “The physical parameter or parameters of interest can include, but are not limited to, measurement of load, force, pressure, position, displacement, density, viscosity, pH, spurious accelerations, and localized temperature. Often, a measured parameter is used in conjunction with another measured parameter to make a qualitative assessment;” similarly recited in Paragraph 0193; Paragraph 0245-0246: “In general, sensors can be used to monitor the synovial fluid that is in proximity to the joint region… There is a strong correlation between the health of a joint and the condition of the synovial fluid. Sensors that measure temperature, pH, color, turbidity, viscosity, glucose, and proteins can be used to analyze synovial fluid”).
Thus, since Stein teaches each of the requisite sensors in separate embodiments, and further teaches that one or more sensors would be suitably used in conjunction with one another to detect multiple parameters, it would be obvious to modify Stein as modified by DiSilvestro include the use of each of sensor recited since using a wide variety of sensors would provide a more comprehensive qualitative assessment of a joint, as well as a more complete analysis monitoring of synovial fluid (see citations above). Examiner further notes that the Federal Circuit has held that if a single prior art document discloses multiple embodiments adjacent to one another (see citations of Stein), then combining such embodiments does not require “a leap of inventiveness.” See Boston Scientific Scimed, Inc. v. Cordis Corp. (2009).
Re. Claim 10: Stein as modified by DiSilvestro teaches the invention according to claim 9. Stein further teaches the invention wherein the at least one battery includes a plurality of batteries (see annotated Fig. 27 in the rejection of claim 1 – at least two batteries 2702 are provided).
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over:
Stein et al. (US 20160089079 A1) (disclosed by Applicant) (hereinafter – Stein) in view of
DiSilvestro et al. (US 20180235514 A1)(disclosed by Applicant) (hereinafter – DiSilvestro) in further view of
Roche et al. (US 20210290063 A1) (disclosed by Applicant) (hereinafter – Roche).
Re. Claim 11: Stein as modified by DiSilvestro teaches the invention according to claim 9. Stein teaches electronic circuitry 2704 can be located between articular surfaces 2710 and 2712 (i.e., akin to medial central region and lateral central regions) underlying region 2714 (i.e., a central region) of support structure 2700 (Paragraph 0201). Thus, Stein teaches placement of electronic circuitry in a region located away from the medical central region and lateral central region (Examiner notes that the size and depth of such regions are broadly defined). Stein as modified by DiSilvestro thus is deficient in reciting that the electronic circuitry comprises a printed circuit board assembly, a processor, a charging coil, and an antenna.
Stein, in another embodiment (Fig. 31) teaches electronic circuitry 3110 also located in a placement required by the claim (i.e., in a central location in an unloaded or lightly-loaded area per Paragraph 0225) formed from PC boards and having a power source/management, communication circuitry implicitly communicative with an antenna due to having a transmissive region 3702, and possessing memory for storing software programs to operate or control a measurement process and to prepare data for transmission (Paragraph 0228).
It would have been obvious to one having skill in the art before the effective filing date to have modified Stein as modified by DiSilvestro to further incorporate such electronic components located in a similar placement within the prosthetic system as taught in another embodiment of Stein, the motivation being that doing so reduces the amount of data processing which needs to be performed at a remote processor, since digital processing and communication circuitry are located within the tibial insert itself, and further locates sensitive elements at a position which does not experience high degrees of loading (Paragraph 0225). Additionally, see prior argument of claim 9 regarding combination of embodiments within the same prior art.
Stein as modified by DiSilvestro as above is deficient in reciting the use of a charging coil.
Roche teaches analogous art in the technology of detecting body parameters (Title; Abstract), particularly of knee prostheses (Paragraph 0216; Figs. 24-25). Roche further teaches that teaches that batteries of implanted sensors may be configured to be charged by an external powering coil (Paragraph 0231). Thus, Roche teaches a charging coil located away from the medial central region and the lateral central region of the implant.
It would have been obvious to one having skill in the art before the effective filing date to have modified Stein as modified by DiSilvestro to include batteries configurable to be charged by an external powering coil, the motivation being that doing so does not require replacement of the batteries when their energy supply is low.
Double Patenting
Claim(s) of this application is patentably indistinct from claim(s) of Application No. 18/213,015. Pursuant to 37 CFR 1.78(f), when two or more applications filed by the same applicant or assignee contain patentably indistinct claims, elimination of such claims from all but one application may be required in the absence of good and sufficient reason for their retention during pendency in more than one application. Applicant is required to either cancel the patentably indistinct claims from all but one application or maintain a clear line of demarcation between the applications. See MPEP § 822.
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claim 1 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 3, 4, and 10 of copending Application No. 18/213,015 (hereinafter – “the ‘015 application”) in view of Stein et al. (US 20160089079 A1) (disclosed by Applicant) (hereinafter – Stein).
Re. Claim 1: Each of claims 3, 4, and 10 (hereinafter – “the identified claims”) of the ‘015 application recite a knee prosthetic comprising a femoral implant, tibial implant, and a tibial insert comprising the claimed regions. The identified claims of the ‘015 application are deficient in reciting “wherein the medial central region and the lateral central region are defined by solid volumes extending from a proximal surface to a distal surface of the tibial insert.”
However, such regions are broadly claimed such that a volume constructed of a solid material of any tibial insert is sufficient to read on such a claim. Stein teaches wherein the medial central region and the lateral central region are defined by solid volumes extending from a proximal surface to a distal surface of the tibial insert (see citations in prior art rejections above).
It would have been obvious to one having skill in the art before the effective filing date to have modified the identified claims to have regions constructed of solid volumes as taught by Stein, the motivation being that solid phase materials are capable of supporting loads encountered by a knee implant, whereby sufficient volumes of such solid material bolster such a capability.
This is a provisional nonstatutory double patenting rejection.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JUSTIN XU whose telephone number is (571)272-6617. The examiner can normally be reached Mon-Fri 7:30-5:00.
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/JUSTIN XU/Primary Examiner, Art Unit 3791
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