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 . Claims 1, & 3-18 are pending and examined below.
Response to Arguments
Applicant's arguments filed 11/26/2025 have been fully considered but they are not persuasive. Applicant argues that the amendments to the independent claim overcome the rejections of record (pages 6-8) and that the dependent claims rise and fall with the same arguments (pages 8-10).
Applicant argues that the prior art, Disilvestro, does not disclose the dashed line around 28 and 30 in figure 1 to be a structure that is coupled to the tibial plate during implant. The examiner respectfully disagrees. Disilvestro discloses in ¶0059 that “sensor 28 is a Hall effect transducer affixed to the proximal tibial component 18 at a position spaced from the tibial bearing 16” and in ¶0089, Disilvestro discloses “the tubular body 114 has an open interior sized and shaped to hold a substantial part of the length of the internal power source 32, and an exterior sized and shaped to fit within the hollow stem 122 of the tibial component 18.” The dashed line of Fig. 1 is better shown in Fig. 15 of which the outer casing encloses the antenna, electronic circuitry, and battery. Under broadest reasonable interpretation, this would teach coupling the outer casing of the implantable reporting processor to the tibial plate as claimed. Therefore, the applicant’s argument is not sufficient to overcome the rejection of record and the rejection is maintained.
The drawing objections has been overcome.
The 112 rejections has been overcome.
Claim Objections
Claim 3 objected to because of the following informalities:
Claim 3 recites “secure the casing”. It is unclear if this is a new casing or the “outer casing”. For the purpose of examination, it is regarded as the outer casing.
Appropriate correction is required.
Claim Rejections - 35 USC § 102
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1-2, 8-14, & 17-18 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Disilvestro et al. (US 20050010301 A1) hereinafter, Disilvestro.
Regarding claim 1, Disilvestro teaches a method of implanting a prosthesis into a patient (Fig. 1, ¶0045), the prosthesis comprising an implantable reporting processor (shown in dashed lines, Fig. 1) having an outer casing (see annotated Fig. 1 below), and a tibial plate (18, Fig. 1), the method comprising:
coupling the outer casing of the implantable reporting processor to the tibial plate (Figs. 1 & 15), the outer casing enclosing an antenna (internal antenna may also be implanted as part of the electronics 30, Fig. 1, ¶0069), electronic circuitry (30, Fig. 1), and a battery (32, Fig. 2); and
comprising a radome (bottom portion of outer dashed lines in Fig. 1) at a first end that covers at least a portion of the antenna (internal antenna may also be implanted as part of the electronics 30, Fig. 1, ¶0069), where the radome comprises a plastic material (biocompatible plastic material, ¶0090) that allows RF signals to propagate to and from the antenna through the radome (RF receiver/modulator to generate a signal that can be transmitted, ¶0105); and
implanting a portion of the prosthesis into a cavity in a tibia of the patient by first inserting the first end of the outer casing into the cavity (Fig. 1).
Regarding claim 8, Disilvestro teaches
wherein the radome (bottom portion of dashed lines in Fig. 1, Disilvestro) comprises a closed end that defines an end of the implantable reporting processor (Fig. 1, Disilvestro).
Regarding claim 9, Disilvestro teaches
wherein the radome comprises a tapered sidewall (Fig. 1, Disilvestro).
Regarding claim 10, Disilvestro teaches
wherein the tapered sidewall reduces in size from a first outer-surface dimension at a first region of the tapered sidewall away from a closed end of the radome, to a second outer-surface dimension less than the first outer-surface dimension at a second region of the tapered sidewall near the closed end (Fig. 1, Disilvestro).
Regarding claim 11, Disilvestro teaches
wherein the antenna comprises a single loop that extends within the radome between the first region of the tapered sidewall to the second region of the tapered sidewall (112 extends down through slot 124 to thread around 120, Figs. 15 - 17, Disilvestro).
Regarding claim 12, Disilvestro teaches
wherein the implantable reporting processor comprises a biocompatible material within the radome (biocompatible plastic material, ¶0090, Disilvestro).
Regarding claim 13, Disilvestro teaches
wherein the biocompatible material fills the radome (136 made of biocompatible material, ¶0090, Disilvestro).
Regarding claim 14, Disilvestro teaches
wherein the radome is void of air (136 surrounds 120, so therefore no air in radome, ¶0090, Disilvestro).
Regarding claim 17, Disilvestro teaches
wherein the electronic circuitry comprises a timing circuit (¶0064, Disilvestro), a processing circuit (microcontroller circuit, Fig. 21, Disilvestro), and an inertial measurement unit (sensor 28, Fig. 1, Disilvestro), and further comprising configuring the timing circuit to activate the processing circuit to selectively couple to the inertial measurement unit at one or more programmed times per day (¶0063-0064, Disilvestro).
Regarding claim 18, Disilvestro teaches
wherein the electronic circuitry comprises a timing circuit (¶0064, Disilvestro), a processing circuit (microcontroller circuit, Fig. 21, Disilvestro), and an inertial measurement unit (sensor 28, Fig. 1, Disilvestro), and further comprising configuring the timing circuit to activate the processing circuit to selectively couple to the inertial measurement unit a number of times per day (¶0063-0064, Disilvestro).
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 3-7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Disilvestro in view of Dietz et al. (US 20090005876 A1) hereinafter, Dietz.
Regarding claim 3, Disilvestro does not disclose a set screw. However, Dietz teaches a tibial tray assembly includes a platform having a stem extending downwardly from a bottom surface and a stem extension (abstract, Dietz)
further comprising using a set screw (56, Fig. 2, Dietz) to secure the casing (outer surfaces of 36 & 38, Fig. 2, Dietz) of the implantable reporting processor to the tibial plate (12, Figs. 2 & 3, Dietz).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Disilvestro by incorporating a set screw as taught by Dietz in order to be received by the treaded bore 30 when the spacer 38 is coupled to the stem 22 of the tibial tray 12 (Fig. 2, ¶0024, Dietz).
Regarding claim 4, Disilvestro teaches
wherein: the outer casing of the implantable reporting processor comprises a central section (central portion of dashed line, Fig. 1, Disilvestro) and a coupling section (where dashed line couples with 18, Fig. 1, Disilvestro).
Disilvestro does not teach the tibial plate comprises a receptacle. However, Dietz teaches
the tibial plate (12, Fig. 2, Dietz) comprises a receptacle (30, Fig. 2, Dietz), and coupling the outer casing (outer surfaces of 36 & 38, Fig. 2, Dietz) of the implantable reporting processor (36 & 38, Fig. 2, Dietz) to the tibial plate (12, Fig. 2, Dietz) comprises inserting the coupling section (44, Fig. 2, Dietz) and a portion of the central section into the receptacle (Figs. 2 & 3, Dietz).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Disilvestro by incorporating a receptacle as taught by Dietz in order to be received by the treaded bore 30 when the spacer 38 is coupled to the stem 22 of the tibial tray 12 (Fig. 2, ¶0024, Dietz).
Regarding claim 5, Disilvestro teaches
wherein the portion of the central section inserted into the receptacle surrounds a first portion of the battery (32 inside 30, Fig. 2, ¶0063, Disilvestro).
Regarding claim 6, Disilvestro teaches
wherein a portion of the outer casing (see annotated Fig. 1 below) of the implantable reporting processor is outside of the receptacle and the portion of the outer casing outside of the receptacle comprises the electronic circuitry (30, Fig. 1, Disilvestro) and the antenna (internal antenna may also be implanted as part of the electronics 30, Fig. 1, ¶0069, Disilvestro).
Regarding claim 7, Disilvestro teaches
wherein a portion of the outer casing (see annotated Fig. 1 below, Disilvestro) of the implantable reporting processor is outside of the receptacle and the portion of the outer casing outside of the receptacle comprises a second portion of the battery (32 inside 30, Fig. 2, ¶0063, Disilvestro).
Claim(s) 15-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Disilvestro in view of Dietz and further in view of Simon et al. (US 20150127068 A1) hereinafter, Simon.
Regarding claim 15, Disilvestro does not teach the battery projected lifetime. However, Simon teaches devices for applying electrical impulse(s) to one or more selected nerves (abstract, Simon)
further comprising configuring the electronic circuitry such that the battery has a projected lifetime of at least one year (less than two years, ¶0007, Simon).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Disilvestro and Dietz by incorporating a battery life as taught by Simon in order to power the system (¶0007, Simon).
Regarding claim 16, Disilvestro does not teach the battery projected lifetime. However, Simon teaches
further comprising configuring the electronic circuitry such that the battery has a projected lifetime of at least ten years (battery life range may be as long as 6.6 to 10 years, ¶0007, Simon).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Disilvestro and Dietz by incorporating a battery life as taught by Simon in order to power the system (¶0007, Simon).
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Conclusion
THIS ACTION IS MADE FINAL. 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 KIA XIONG WHITE whose telephone number is (703)756-4773. The examiner can normally be reached 0830-1630 EST.
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/K.X.W./Examiner, Art Unit 3774
/YASHITA SHARMA/Primary Patent Examiner, Art Unit 3774
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