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 .
Response to Amendment
The amendment filed August 19, 2026 has been entered.
Claim 3 is cancelled, and analogous subject matter thereof is incorporated into independent claim 1.
Claims 1, 2, and 4-20 are pending. Claims 11-20 are previously withdrawn from further consideration.
Applicant’s arguments are sufficient to obviate the drawing objection.
Applicant’s amendments are sufficient to obviate the objection to claim 9; however, a new objection to claim 7 is presented.
Applicant’s amendments and arguments are insufficient to overcome the current prior art rejections.
Applicant’s arguments are insufficient to overcome the nonstatutory double patenting rejection; the rejection is held in abeyance.
Response to Arguments
Applicant's arguments filed August 19, 2026 have been fully considered but they are not persuasive.
Regarding Applicant’s argument:
“The medial and lateral regions of Stein's tibial insert 2700 (Fig. 27) are not "solid volumes" extending from the proximal surface to the distal surface. Stein expressly describes a two-piece insert in which a support structure 2706 carries the articular surfaces 2710 and 2712 while a separate support structure 2708 houses the sensing and electronics package directly beneath those articular surfaces… By Stein's own express disclosure, the medial and lateral columns running from the proximal articular surfaces 2710/2712 down to the distal load-bearing surface 2724 contain the sensing and electronics package that claim 1 of the present application requires to be elsewhere. Stein therefore fails to disclose the "solid volumes extending from a proximal surface to a distal surface" limitation of claim 1.”
Applicant’s argument is incommensurate with the scope of the claim. A “medial central region” and “lateral central region” as identified in the annotated figure of Stein are reasonably interpretable as being defined by solid volumes (i.e., the upper and lower portions of the two-piece insert as identified by Applicant). That is, the upper and lower portions each comprise a solid material and respectively occupy a thin, but three-dimensional, volume to form an enclosure.
Regarding Applicant’s argument:
“Further, Stein affirmatively places its sensors and electronics within the medial and lateral columns of the insert. This is the opposite of the amended claim 1 requirement that the at least one sensor and the battery be "disposed outside both the medial central region and the lateral central region. The Action's annotation of Stein's Fig. 27 (page 5 of the Action) identifies the medial and lateral central regions as the columns directly above load plates 2716/2720, but those are precisely the columns Stein uses to carry the load pads 2722, capacitor sensors, and interconnect 2718.”
Applicant’s misconstrues Examiner’s annotation. In layman’s terms, a “medial central region” and “lateral central region” are only defined in the claims as regions to the left and right of a central region. Such left and right regions are defined by Examiner as separated from a central region delineated by a bounding box containing at least one sensor 2722 and battery 2702; thus, such components are located away from regions outside of a bounding box surrounding them. Applicant appears to argue the interpretation that each sensor 2722 must be located away from the medial and lateral central regions. Examiner further notes that a size of a central relative to its medial and lateral central regions is not defined, only its relative placement, and that a central region may be interpreted to occupy up to the peripheral edges of the tibial insert, with minimal medial and lateral central regions.
Applicant’s argument directed to the nonstatutory double patenting rejection are not persuasive; since medial and lateral central regions are only defined relatively, the obviousness-type rejection including the teachings of Stein encompasses each requirement of the present claims.
Claim Objections
Claim 7 is objected to because of the following informalities:
“includes a Hall sensors” should read as “includes a Hall sensor”
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, 2, and 4-6 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),
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 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 4: Stein teaches the invention according to claim 1. 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 1. 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 1, 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 includes a plurality of sensors, the plurality of sensors including the Hall sensor (see modification of DiSilvestro incorporating such sensors) and 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
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Alexander Valvis can be reached at (571) 272-4233. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JUSTIN XU/Primary Examiner, Art Unit 3791
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