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 .
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 7, 8, and 17 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.
Claim 7 recites the limitation "wherein the at least one path" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 8 recites the limitation "wherein the at least one path" in line 1. There is insufficient antecedent basis for this limitation in the claim.
It is noted that while claim 1 recites “a path,” it does not recite “at least one path.”
Claim 17 recites the limitation "the two longer lateral sides" in line 2. There is insufficient antecedent basis for this limitation in the claim.
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.
Claim(s) 1 – 20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Zellmer et al (US PGPUB 2021/0128919).
Regarding claims 1 – 17, Zellmer (‘919) discloses a nearly identical specification and identical claims 1 – 17. While having the same inventors, the ‘919 publication qualifies as prior art under 102(a)(1) as being published more than a year before the filing date of the present application. It is noted the priority claim to the ‘929 publication (application 17/087,155) has not been entered because it was not filed during the required time period.
Regarding claims 18 and 19, Zellmer discloses a method for the construction of a medical implant device comprising:
constructing a circuitry surface with a set of electronic components, the set of electronic components comprising at least one conductively connected antenna and a conductively connected set of electrodes;
configuring the circuitry surface along a path; and
molding an implant body around the circuitry surface (e.g. ¶ 125),
wherein constructing the circuitry surface comprises assembling a circuitry system on the circuitry surface (e.g. ¶ 125).
Regarding claim 20, Zellmer discloses constructing a casing; housing and securely sealing within the casing a casing circuitry subsystem; connecting the casing to the implant body and conductively connecting the set of electronic components of the circuitry surface to the casing circuitry subsystem; wherein the casing circuitry subsystem contains all non-biocompatible electronic components of a circuit system of the medical implant device (e.g. ¶ 126).
Claim(s) 1 – 9, 18, and 19 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Stevenson et al. (US PGPUB 2017/0007420).
Regarding claim 1, Stevenson discloses a system for embedded electronics within a medical implant (e.g. spinal implant system 10) comprising:
an implant body (e.g. interbody implant 12);
a circuitry system (e.g. ¶ 40 discloses a circuitry system comprising a PCB, electrodes, and other electronic components) comprising a circuitry surface that is at least partially embedded along a path within a defined internal cavity of the implant body (e.g. Fig. 2 shows the circuitry surface, made up of printed circuit board assembly 80, along a path of a cavity within interbody implant 12), wherein the circuitry surface contains at least one electronic component (e.g. antenna 90, NFC device 86, sensor 92), and wherein the implant body is formed around the circuitry surface (e.g. Fig. 1 shows implant 12 being formed around circuitry surface; ¶ 40);
electronic components integrated with the circuitry surface, and comprising:
a set of electrodes (e.g. ¶ 42 discloses endcaps 34 include electrodes; par. 0047 discloses endcaps 60 include electrodes) and
an antenna (e.g. antenna 90); and
wiring, connecting the circuitry surface and electronic components (although not shown, wiring is inherent to an electronic implant with a circuitry system).
Regarding claim 2, Stevenson discloses a casing, a sealed structure directly connected to the implant body (e.g. Fig. 2 – reproduced below), wherein the circuitry system further comprises a casing circuitry subsystem (e.g. Fig. 2 shows subsystem, comprising diagnostic sensors, and NFC integrated circuit device, and an analog integrated circuit device, within casing).
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Regarding claim 3, Stevenson discloses the casing circuitry subsystem comprises a printed circuit board (PCB) contained within the casing (e.g. Fig. 3 shows PCB 80 being located near the other previously mentioned casing circuitry subsystem devices); and wherein the wiring electrically connects the PCB and electrical components embedded within the implant body (although not disclosed, inherently, wiring must connect the PCB to the other electrical components).
Regarding claim 4, Stevenson discloses the circuitry surface comprises a printed circuit board (PCB) (e.g. ¶ 30).
Regarding claim 5, Stevenson discloses a sheathing with a protective structure, wherein the at least partially embedded portion of the circuitry surface is enclosed within the sheathing (e.g. Fig. 4 shows how the circuitry system is enclosed cage 14, which acts as a protective sheathing; ¶ 40 discloses cage 14).
Regarding claim 6, Stevenson discloses the sheathing is composed of silicone, such that the PCB embedded in the defined cavity is enclosed and covered by a silicone sheathing (e.g. ¶ 36 discloses the materials of spinal implant system 10, which includes cage 14, can be made of silicone).
Regarding claim 7, Stevenson discloses the at least one path comprises a single straight line, or curved, path (e.g. Fig. 2 shows the path of the circuitry system being shaped as an “L”, therefore each path is a single straight line), and the PCB is embedded within the implant body along the single straight line, or curved, path (e.g. Fig. 2 shows PCB 80 being implanted along the path of the circuitry system).
Regarding claim 8, Stevenson discloses the at least one path comprises multiple straight line, or curved, paths, (e.g. Fig. 2, as previously stated, shows the path of the circuitry comprises multiple straight lines in the shape of an “L”) and the embedded PCB along the multiple paths comprises a folded PCB (e.g. Fig. 10 shows how the PCB is folded into a rectangular shape), roughly matching the shape of the multiple paths (e.g. Fig. 3 shows the circuit board assembly 80 have substrate 82 that folds around the corners of spinal implant system 10 and continues down the lateral sides).
Regarding claim 9, Stevenson discloses the folded PCB is in a table geometry (e.g. Fig. 10 shows the PCB in a folded table geometry, seen by the two longer lateral sides extending from circuit 282; this is assumed to be similar for the embodiment relied upon in Fig. 3), such that the middle portion (e.g. Fig. 3 circuit board assembly 80) of the PCB has a face normal to the direction of insertion into the implant body (e.g. Fig. 3 below shows the direction of insertion and a face of the PCB that would run normal to the direction of insertion; because the face is running along the width of the spinal implant, as illustrated, this would be parallel to the direction of insertion, as illustrated), and that both ends of the PCB are bent (e.g. Fig. 3 shows substrate 82 folding around the corners of spinal implant system 10 and continuing along a lateral side of the implant) and inserted into a deeper portion of the defined PCB cavity (e.g. Fig. 3 below; because the sides are extending out from circuit board 80 toward the center of the spinal implant, as shown below, they are being inserted into a deeper portion of the cavity).
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Regarding claims 18 and 19, Stevenson discloses a method for the construction of a medical implant device (e.g. ¶ 31) comprising:
constructing a circuitry surface with a set of electronic components, the set of electronic components comprising at least one conductively connected antenna and a conductively connected set of electrodes (e.g. ¶ 26 – 31);
configuring the circuitry surface along a path (e.g. ¶ 30); and
molding an implant body around the circuitry surface (e.g. ¶ 30),
wherein constructing the circuitry surface comprises assembling a circuitry system on the circuitry surface (e.g. ¶ 30).
Claim(s) 1, 4, 8, and 10 – 13 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Linden et al. (USPN 11,097,096).
Regarding claim 1, Linden discloses a system for embedded electronics within a medical implant (e.g. implantable system 20) comprising:
an implant body (e.g. implantable device 200);
a circuitry system (e.g. foldable electronics assembly 300) comprising a circuitry surface that is at least partially embedded along a path within a defined internal cavity of the implant body (e.g. col. 87 lines 15-20 discloses how the circuitry surface is embedded inside opening 212 of implantable device 200), wherein the circuitry surface contains at least one electronic component (e.g. col. 87 lines 15-41 discloses the electronic components of the circuitry surface), and wherein the implant body is formed around the circuitry surface (e.g. col. 87 lines 17-20 discloses the circuitry surface is inside implantable device 200);
electronic components integrated with the circuitry surface, and comprising:
a set of electrodes (e.g. stimulation elements 260) and
an antenna (e.g. antenna 240); and
wiring, connecting the circuitry surface and electronic components (although not shown, wiring is inherent to an electronic implant with a circuitry system).
Regarding claim 4, Linden discloses the circuitry surface comprises a printed circuit board (PCB) (e.g. circuit board 305).
Regarding claim 8, Linden discloses the at least one path comprises multiple straight line, or curved, paths, and the embedded PCB along the multiple paths comprises a folded PCB, roughly matching the shape of the multiple paths (e.g. Fig. 5B shows the path of the circuitry system with bendable portions 355-357 of the PCB that are able to fold).
Regarding claim 10, Linden discloses the folded PCB (e.g. Figs. 5B and 5C show the folding ability of the PCB) may be folded such that the PCB has at least one normal surface to all three space dimensions (e.g. discloses the PCB has multiple bendable sections, specifically bendable portions 355-357 that allow regions 350-353 to fold, thus allowing the PCB to have a normal surface in all three dimensions; this is further seen in Linden Fig. 5C).
Regarding claim 11, Linden discloses each normal surface (e.g. regions 350-353) of the PCB (e.g. circuit board 305) contains an antenna component (e.g. antenna 240) such that the antenna spans all space dimensions (e.g. col. 87 line 62 – col. 88 line 30 disclose the antenna is able to fold with bendable portions of the circuit board; therefore, like the PCB, the antenna would be able to fold in such a way that it spans all dimensions).
Regarding claim 12, Linden discloses wherein the folded PCB is folded in an accordion manner, such that the PCB is folded back and on itself multiple times (e.g. col. 87 discloses bendable portions 355-357 are all able to fold toward either side due to their neutral axis of the bend, therefore this means the portions are able to fold on top of one another in an accordion manner).
Regarding claim 13, Linden discloses the antenna comprises multi-layered geometry, wherein adjacent layers of the PCB contain a part of the antenna, thus forming a relatively three-dimensional antenna comprising stacked planar folds (Linden col. 88 discloses antenna 240 can be constructed in such a way that it folds over foldable portion 357, therefore it would be able to fold into a stacked planar fold with the PCB).
Claim(s) 1, 4, and 14 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Zellmer et al. (US PGPUB 2020/0108252).
Regarding claim 1, Zellmer discloses a system for embedded electronics within a medical implant (e.g. ¶ 24) comprising:
an implant body (e.g. implant body 100);
a circuitry system (e.g. power system 130) comprising a circuitry surface that is at least partially embedded along a path within a defined internal cavity of the implant body (e.g. ¶ 39 discloses the implant houses circuitry components; ¶ 38 discloses circuitry components are within internal cavity of the implant, therefore they must be embedded along a path), wherein the circuitry surface contains at least one electronic component (e.g. ¶ 39 discloses the circuitry components include PCB, leads, and/or antennas), and wherein the implant body is formed around the circuitry surface (e.g. Fig. 3B illustrates how the implant body is formed around the circuitry surface; it is assumed this is similarly true for all embodiments of Zellmer);
electronic components integrated with the circuitry surface, and comprising:
a set of electrodes (e.g. electrodes 112, 116) and
an antenna (e.g. ¶ 39); and
• wiring, connecting the circuitry surface and electronic components (although not shown, wiring is inherent to an electronic implant with a circuitry system).
Regarding claim 4, Zellmer discloses the circuitry surface comprises a printed circuit board (PCB) (e.g. ¶ 39 discloses the implant can house a PCB).
Regarding claim 14, Zellmer discloses a casing including a circuitry system enclosed in the casing, wherein the casing is physically coupled to the implant body with the circuitry system operatively coupling to the circuitry surface (e.g. ¶ 39-40 disclose the implant may be a spinal cage that is made of various material, such as PEEK, therefore, this acts as a casing surrounding the implant body in which the circuitry system is enclosed within).
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.
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(s) 15 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Stevenson et al. in view of Moffitt (US PGPUB 20080294211).
Regarding claims 15 and 20, Stevenson discloses the circuitry system enclosed in the casing comprises a PCB (e.g. printed circuit board assembly 80) that is electrically connected to electronic components within the implant body (inherently, the printed circuit board assembly 80 of Stevenson has to be electrically connected to the previously disclosed electronic components). However, Stevenson fails to disclose the casing is hermetically sealed.
Moffitt discloses a casing (e.g. outer case 15) of an implant body (e.g. implantable pulse generator 14) is hermetically sealed (e.g. ¶ 38 discloses the outer case is hermetically sealed).
It would have been obvious to one having ordinary skill in the art to modify the casing of Stevenson by using hermetic sealing as taught by Moffitt, since such a modification would provide the predictable results of protecting the internal electronics from surrounding body tissues and fluids.
Claim(s) 16-17 are rejected under 35 U.S.C. 103 as being unpatentable over Zellmer et al. (US PGPUB 2020/0108252) and further in view of Stevenson et al. (US PGPUB 2017/0007420)
Regarding claim 16, Zellmer discloses the implant body comprises a relatively rectangular spinal cage (e.g. Fig. 9 shows the rectangular shape of a spinal cage implant, ¶ 44). However, Zellmer fails to disclose a casing physically connected to a shorter lateral side of the spinal cage.
Stevenson discloses a casing (e.g. cage 14) physically connected to a shorter lateral side (e.g. Fig. 1 shows leading end 18 having a rounded end, thus being shorter than insertion end 20, which is flat-ended) of a spinal cage (e.g. implant 12).
It would have been obvious to one having ordinary skill in the art to modify the shape of the spinal cage implant of Zellmer by making one end have a shorter side as taught by Stevenson, since such a modification would provide the predictable results of preventing the implant from damaging any surrounding tissue and/or nerves during insertion.
Regarding claim 17, Zellmer discloses the circuitry surface comprises two planar surfaces embedded in the two longer lateral sides of the rectangular spinal cage (e.g. Fig. 9 below; although a different embodiment, this feature can be seen in Fig. 3B in which the a circuitry surface is embedded along a lateral side just behind the electrodes; based on this, Fig. 9 would similarly have a circuitry surface along the lateral sides behind the electrodes); wherein each planar surface contains two electrodes exposed on the exterior surface of the implant body (e.g. Fig. 9, upper illustration shows electrodes 112, 116 on the exterior surface; the lower illustration of Fig. 9 shows electrodes on each exterior surface), extending normal and outward from the planar surface (e.g. Fig. 9, lower illustration shows electrodes 112 and 116 extending outward from the planar surface); and wherein each planar surface contains two electrodes exposed on the interior surface of the implant body, extending normal and inward from the planar surface (e.g. Fig. 9, lower illustration shows two electrodes on each interior surface, each electrode extending inward). However, Zellmer fails to discloses each planar surface has an antenna wrapped around the exterior circumference of the planar surface along the same dimension of the planar surface.
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Stevenson discloses that a planar surface has an antenna wrapped around an exterior circumference along the same dimension of the planar surface (e.g. Fig. 3 shows antenna 90 on lateral side planar surface; it is assumed that the opposite side planar surface also has antenna 90).
It would have been obvious to one having ordinary skill in the art to modify the implant of Zellmer by providing an antenna that runs along each lateral planar side as taught by Stevenson, since such a modification would provide the predictable results of transferring power throughout the interbody implant or serve as a source of data transmission. Because Zellmer discloses that antennas may be housed within the implant body (Zellmer ¶ 39) but does not disclose where the antennas may be located, it is obvious that such antennas could be located around the exterior circumference of a planar surface.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOSEPH M DIETRICH whose telephone number is (571)270-1895. The examiner can normally be reached Mon - Fri 8:00-5:00.
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/JOSEPH M DIETRICH/Primary Examiner, Art Unit 3796