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 Objections
Claims 5, 9, 11-14, and 17 are objected to because of the following informalities:
Claim 5 recites “the electrode” in line 2, which appears to be referring to – the at least one electrode –, as recited earlier in the claim.
Claim 5 recites “each electrode region” in line 7, which appears to be referring to – each of the two distinct regions –, as recited earlier in the claim.
Claim 9 recites “the additional region” in line 3, which appears to be referring to – that additional region –, as recited earlier in the claim.
Claim 11 recites “each alternating layer” in line 1, which appears to be referring to – each additional layer –.
Claim 12 recites “the electrode” in line 1, which appears to be referring to – each electrode –.
Claim 13 recites “a flat sheet” twice in line 2. The examiner suggests amending the second occurrence of “a flat sheet” to recite – a second flat sheet – for clarification purposes.
Claim 14 recites “each electrode” in line 1, which appears to be referring to – the at least one electrode –, as previously recited in claim 5, from which claim 14 depends.
Claim 14 recites “the first material region”, which appears to be referring to – the first region –, as previously recited in claim 5, from which claim 14 depends.
Claim 14 recites “the different material region of the electrode”, which appears to be referring to – the second distinct region of the at least one electrode –, as previously recited in claim 5, from which claim 14 depends.
Claim 14 recites “the two regions”, which appears to be referring to – the two distinct regions –, as previously recited in claim 5, from which claim 14 depends.
Claim 17 recites “the electrode” in line 2, which appears to be referring to – the at least one electrode –, as recited earlier in the claim.
Claim 17 recites “an electrode region” in line 6, which appears to be referring to – each of the two distinct regions –, as recited earlier in the claim.
Appropriate correction is required.
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 6, 12, and 18 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 6 recites the limitation "the exposed electrode site" in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 12 recites “a flat sheet” in line 3, “a flat sheet” in line 4, and “prior flat sheet” in lines 6 and 8. It is unclear to which prior flat sheet applicant is referring. The examiner suggests amending the second occurrence of “a flat sheet” to recite – a second flat sheet – and specify whether the second flat sheet is the “prior flat sheet”.
Claim 18 recites the limitation "the first material region and the different material region of the electrode” in lines 2-3 and “the two regions” in line 4. There is insufficient antecedent basis for these limitations in the claim. For the purpose of further examination, the examiner interprets claim 18 to depend from claim 17, which would provide antecedent basis for – the at least one region –, – the distinct second region –, and – the at least one electrode –.
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 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, 2, and 15 is/are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by US Patent Application Publication No. 2016/0270927 A1 to Zellmer et al. (Zellmer).
Regarding at least claim 1
Zellmer teaches a system and method for electrical stimulation in an orthopedic implant that includes at least one implantable component with an implant body, a plurality of electrodes, and implant circuitry (abstract). Zellmer meets the limitations of a system for altering bone growth near an orthopedic implant comprising: an implant body (paragraph 0041 discloses an implant body that facilitates the generation of osteoconductive regions that promote bone growth), wherein the implant body comprises an exterior surface (outer surface) and an interior surface defining an internal cavity of the implant body (paragraphs 0063 and 0066 discloses that the implantable component may be an insert which may be fixed to some portion of the implant structure such as within the internal cavity of a spinal cage); a plurality of electrodes (13; paragraph 0073 discloses a plurality of electrodes), wherein each electrode is at least partially embedded in the implant body (paragraph 0073 discloses that the electrode sites may be recessed within the implant body which is interpreted as being at least partially embedded), and comprises at least: - a first set of electrodes from the plurality of electrodes, composed of a first material, and - a second set of electrodes from the plurality of electrodes, composed of a second material (paragraph 0041 discloses electrode sites distributed across the geometry of the implant bodies in such a way as to facilitate the generation of osteolytic or osteoinductive regions and that the electrodes can be conductively isolated from a subset of the other electrodes and more preferable conductively isolated from each of the set of electrodes such that each electrode could be independently controlled; the examiner notes that the first and second material are not required to be different materials and also that since some of the electrodes are meant for osteolytic regions and some are for osteoinductive regions, one of ordinary skill in the art would recognize the benefit of using different materials for achieving different results); and a control system, comprising a processor (paragraph 0068 discloses implant circuitry composed of various processing units e.g. microprocessors) and circuitry (12) that connects to the plurality of electrodes, - wherein the processor comprises machine instructions configured to control direction and magnitude of current traveling through each electrode from the plurality of electrodes (paragraph 0068 discloses implant circuitry that is effective to control one or more of said electrodes with respect to whether electric current is flowing through the electrode or is not flowing through the electrode, and when current is flowing through the electrode with respect to one or more characteristics of the current flowing through the electrode; at least paragraph 0051 discloses controlling magnitude of current and at least paragraph 0059 discloses adjusting directionality of the current); and a power system comprising a power source (18) and circuitry (19) that provides electrical power for function of the plurality of electrodes (paragraph 0046 discloses a system which functions to deliver power to and/or communicate with the implantable component).
Regarding at least claim 2
Zellmer teaches the system of claim 1, wherein the implant body is a spinal cage (paragraph 0041 discloses that the medical implant may be a spine cage), and the plurality of electrodes include: a subset of the electrodes composed of the first material that are partially embedded in the spinal cage and partially exposed at electrode sites on the interior surface of the spinal cage, and a subset of electrodes composed of the second material that are partially embedded in the spinal cage and partially exposed at electrode sites on the exterior surface of the spinal cage (paragraph 0073 discloses at least two different electrode sites with differing geometry which are preferably flush with the surface of the body or may protrude from the implant body or be recessed within the implant body; as best understood by the examiner, a first electrode site is a subset of electrodes and a second electrode site is a subset of electrodes, both electrodes are composed of a material, and the electrodes that are flush with the surface are partially exposed and partially embedded, as claimed).
Regarding at least claim 15
Zellmer teaches the system of claim 1, wherein the first set of electrodes from the plurality of electrodes includes exposed electrode sites proximal to a bone growth region, and the second set electrodes from of the plurality of electrodes includes exposed electrode sites distal to the bone growth region (paragraph 0073 discloses that the plurality of electrodes are exposed on an outer surface of the implant body which promotes conductively coupling with the surrounding body tissue and that the electrode sites are distributed across the geometry of the implant bodies in such a way as to facilitate the generation of osteolytic or osteoinductive regions during a controlled stimulation mode; as best understood by the examiner, the electrodes of Zellmer include exposed electrode sites proximal to a bone growth region and exposed electrode sites distal to the bone growth region, depending on which areas are intended for osteolysis and which areas are intended for osteoinduction; the examiner also notes that this limitation is functional and depends on where/how/whether the implant is placed in a patient).
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 3, 4, 16, and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zellmer in view of US Patent Application Publication No. 2011/0009728 A1 to Schouenborg (Schouenborg).
Regarding at least claims 3 and 4
Zellmer teaches the system of claim 1. However, Zellmer does not teach wherein the first material is platinum or wherein the second material is titanium.
Schouenborg teaches a medical electrode having a body that consists of an electrically conductive material, such as platinum or titanium (paragraph 0010) and is used for recording and/or nerve-stimulating purposes (paragraph 0021).
It would have been obvious to one having ordinary skill before the effective filing date of the claimed invention to specify that the electrode of Zellmer, which is used for providing electrical stimulation (paragraph 0049), is composed of a first material that is platinum and a second material that is titanium, since these materials are both well known as being used for electrodes in the body and are electrically conductive, as taught by Schouenborg, and also since it is prima facie obvious to select a known material based on its suitability for an intended purpose (See MPEP 2144.07).
Regarding at least claim 16
Zellmer meets the limitations of a system for altering bone growth near an orthopedic implant comprising: an implant body (paragraph 0041 discloses an implant body that facilitates the generation of osteoconductive regions that promote bone growth), wherein the implant body comprises an exterior surface (outer surface) and an interior surface defining an internal cavity of the implant body (paragraphs 0063 and 0066 discloses that the implantable component may be an insert which may be fixed to some portion of the implant structure such as within the internal cavity of a spinal cage); a plurality of electrodes (13; paragraph 0073 discloses a plurality of electrodes), wherein each electrode is at least partially embedded in the implant body (paragraph 0073 discloses that the electrode sites may be recessed within the implant body which is interpreted as being at least partially embedded), and comprises at least: - a first set of electrodes from the plurality of electrodes, and - a second set of electrodes from the plurality of electrodes (paragraph 0041 discloses electrode sites distributed across the geometry of the implant bodies in such a way as to facilitate the generation of osteolytic or osteoinductive regions and that the electrodes can be conductively isolated from a subset of the other electrodes and more preferable conductively isolated from each of the set of electrodes such that each electrode could be independently controlled; the examiner notes that the first and second material are not required to be different materials and also that since some of the electrodes are meant for osteolytic regions and some are for osteoinductive regions, one of ordinary skill in the art would recognize the benefit of using different materials for achieving different results); and a control system, comprising a processor (paragraph 0068 discloses implant circuitry composed of various processing units e.g. microprocessors) and circuitry (12) that connects to the plurality of electrodes, - wherein the processor comprises machine instructions configured to control direction and magnitude of current traveling through each electrode from the plurality of electrodes (paragraph 0068 discloses implant circuitry that is effective to control one or more of said electrodes with respect to whether electric current is flowing through the electrode or is not flowing through the electrode, and when current is flowing through the electrode with respect to one or more characteristics of the current flowing through the electrode; at least paragraph 0051 discloses controlling magnitude of current and at least paragraph 0059 discloses adjusting directionality of the current); and a power system comprising a power source (18) and circuitry (19) that provides electrical power for function of the plurality of electrodes paragraph 0046 discloses a system which functions to deliver power to and/or communicate with the implantable component).
However, Zellmer does not teach that the first set of electrodes from the plurality of electrodes, composed of a platinum or that the second set of electrodes from the plurality of electrodes, composed of a titanium.
Schouenborg teaches a medical electrode having a body that consists of an electrically conductive material, such as platinum or titanium (paragraph 0010) and is used for recording and/or nerve-stimulating purposes (paragraph 0021).
It would have been obvious to one having ordinary skill before the effective filing date of the claimed invention to specify that the electrode of Zellmer, which is used for providing electrical stimulation (paragraph 0049), is composed of a first material that is platinum and a second material that is titanium, since these materials are both well known as being used for electrodes in the body and are electrically conductive, as taught by Schouenborg, and also since it is prima facie obvious to select a known material based on its suitability for an intended purpose (See MPEP 2144.07).
Regarding at least claim 19
Zellmer in view of Schouenborg teaches the system of claim 16. Zellmer also teaches wherein the first set of electrodes includes exposed electrode sites proximal to a bone growth region, and the second set of electrodes includes exposed electrode sites distal to the bone growth region (paragraph 0073 discloses that the plurality of electrodes are exposed on an outer surface of the implant body which promotes conductively coupling with the surrounding body tissue and that the electrode sites are distributed across the geometry of the implant bodies in such a way as to facilitate the generation of osteolytic or osteoinductive regions during a controlled stimulation mode; as best understood by the examiner, the electrodes of Zellmer include exposed electrode sites proximal to a bone growth region and exposed electrode sites distal to the bone growth region, depending on which areas are intended for osteolysis and which areas are intended for osteoinduction; the examiner also notes that this limitation is functional and depends on where/how/whether the implant is placed in a patient).
Double Patenting
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.
Claims 1-18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 11,471,297 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because:
Regarding claim 1, the patent claims also recite a system for altering bone growth near an orthopedic implant comprising: an implant body, wherein the implant body comprises an exterior surface and an interior surface defining an internal cavity of the implant body; a plurality of electrodes, wherein each electrode is at least partially embedded in the implant body, and comprises at least: - a first set of electrodes from the plurality of electrodes, composed of a first material, and - a second set of electrodes from the plurality of electrodes, composed of a second material; and a control system, comprising a processor and circuitry that connects to the plurality of electrodes, - wherein the processor comprises machine instructions configured to control direction and magnitude of current traveling through each electrode from the plurality of electrodes; and a power system comprising a power source and circuitry that provides electrical power for function of the plurality of electrodes (see patent claim 1).
Regarding claim 2, the patent claims also recite the system of claim 1, wherein the implant body is a spinal cage, and the plurality of electrodes include: a subset of the electrodes composed of the first material that are partially embedded in the spinal cage and partially exposed at electrode sites on the interior surface of the spinal cage, and a subset of electrodes composed of the second material that are partially embedded in the spinal cage and partially exposed at electrode sites on the exterior surface of the spinal cage (see patent claim 2).
Regarding claim 3, the patent claims also recite the system of claim 1, wherein the first material is platinum (see patent claim 3).
Regarding claim 4, the patent claims also recite the system of claim 3, wherein the second material is titanium (see patent claim 4).
Regarding claim 5, the patent claims also recite the system of claim 1, wherein at least one electrode from the first set of electrodes is further comprised of two distinct regions, wherein the electrode further comprises: a first region composed of the first material, and a second distinct region composed of a different material; wherein the at least one electrode further comprises a switch conductively coupled to the at least one electrode and configured to selectively enable current to travel through each electrode region (see patent claim 1).
Regarding claim 6, the patent claims also recite the system of claim 5, wherein the at least one electrode comprises circuitry configured to enable opposite currents to flow through the first and second distinct regions of the electrode thereby creating an electric field at the exposed electrode site of the electrode that promotes bone growth (see claim 5).
Regarding claim 7, the patent claims also recite the system of claim 5, wherein the first material comprises platinum and the different material comprises titanium (see patent claim 6).
Regarding claim 8, the patent claims also recite the system of claim 5, wherein each electrode from the first set of electrodes is a two- layer wire comprising: a central cylindrical layer composed of the first material, and a hollow cylindrical layer surrounding the central cylindrical layer, composed of the different material (see patent claim 7).
Regarding claim 9, the patent claims also recite the system of claim 5, wherein each electrode from the first set of electrodes further comprises multiple distinct regions, wherein each additional region is composed of a material distinct from all regions adjacent to the additional region (see patent claim 8).
Regarding claim 10, the patent claims also recite the system of claim 9, wherein each electrode from the first set of electrodes is a multi- layer wire, comprising: a central cylindrical layer composed of the first material; a second cylindrical layer surrounding the central cylindrical layer, composed of the different material; and at least one additional hollow cylindrical layer surrounding the second cylindrical layer, composed of a distinct material as compared to the second cylindrical layer (see patent claim 9).
Regarding claim 11, the patent claims also recite the system of claim 10, wherein each alternating layer after the central cylindrical layer comprises an insulating layer composed of electrically insulating material (see patent claim 10).
Regarding claim 12, the patent claims also recite the system of claim 9, wherein the electrode with multiple distinct regions is a multi- layer sheet, comprising: a flat sheet composed of the first material, a flat sheet composed of the different material stacked upon the first material; and at least one additional flat sheet layer stacked upon a prior flat sheet, wherein the additional flat sheet layer is composed of a distinct material as compared to its prior flat sheet (see patent claim 11).
Regarding claim 13, the patent claims also recite the system of claim 5, wherein each electrode comprises a two-layer conducting sheet, comprising a flat sheet composed of the first material and a flat sheet composed of the different material (see patent claim 12).
Regarding claim 14, the patent claims also recite the system of claim 5, wherein each electrode comprises a circuit component with a switch, such that the first material region and the different material region of the electrode are parallel components of the circuit, and the switch enables current to selectively flow only through one of the two regions (see patent claim 13).
Regarding claim 15, the patent claims also recite the system of claim 1, wherein the first set of electrodes from the plurality of electrodes includes exposed electrode sites proximal to a bone growth region, and the second set electrodes from of the plurality of electrodes includes exposed electrode sites distal to the bone growth region (see patent claim 14).
Regarding claim 16, the patent claims also recite a system for altering bone growth near an orthopedic implant comprising: an implant body, wherein the implant body comprises an exterior surface and an interior surface defining an internal cavity of the implant body; a plurality of electrodes, wherein each electrode is at least partially embedded in the implant body, and comprises at least: - a first set of electrodes from the plurality of electrodes, composed of a platinum, and - a second set of electrodes from the plurality of electrodes, composed of a titanium; and a control system, comprising a processor and circuitry that connects to the plurality of electrodes, - wherein the processor comprises machine instructions configured to control direction and magnitude of current traveling through each electrode from the plurality of electrodes; and a power system comprising a power source and circuitry that provides electrical power for function of the plurality of electrodes (see patent claim 15).
Regarding claim 17, the patent claims also recite the system of claim 16, wherein at least one electrode from the first set of electrodes is further comprised of two distinct regions, wherein the electrode further comprises of at least one region composed of the platinum and a distinct second region composed of a different material, wherein the at least one electrode further comprises a switch conductively coupled to the at least one electrode selectively allowing current to travel through an electrode region (see patent claim 15).
Regarding claim 18, the patent claims also recite the system of claim 16, wherein each electrode comprises a circuit component with a switch, such that the first material region and the different material region of the electrode are parallel components of the circuit, and the switch enables current to selectively flow only through one of the two regions (see patent claim 16).
Regarding claim 19, the patent claims also recite the system of claim 16, wherein the first set of electrodes includes exposed electrode sites proximal to a bone growth region, and the second set of electrodes includes exposed electrode sites distal to the bone growth region (see patent claim 17).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MELISSA A HOBAN whose telephone number is (571)270-5785. The examiner can normally be reached Monday-Friday 8:00AM-5:00PM.
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/M.A.H/Examiner, Art Unit 3774
/BRIAN A DUKERT/Primary Examiner, Art Unit 3774