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
Claims 17-36 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Inventions II, III, and IV, there being no allowable generic or linking claim.
Election was made without traverse in the reply filed on 12 December 2025 of Invention I, directed to Claims 1-16.
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.
Claim 9 is 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.
Regarding Claim 9, the claim recites the limitation "the plurality of microneedles". There is insufficient antecedent basis for this limitation in the claim. For purposes of examination, the Examiner is interpreting this limitation as “a plurality of microneedles”. Appropriate correction or clarification is required.
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.
Claims 1, 2, and 13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Koester (US Publication No. 2012/0016444).
Regarding Claim 1, Koester discloses an auditory nerve stimulation system (cochlear prothesis/implant, Paragraph 0018, 0023), comprising:
an implantable electrode array (electrodes in array, 195, Fig. 3; Paragraph 0029);
a first electrical lead (190, Fig. 3; Paragraph 0029, 0026, 0032) electrically coupled to and extending from the implantable electrode array (195, Fig. 3);
an auditory signal device (internal processor 185, Fig. 3, 5C; Paragraph 0026, 0029, 0048) configured to produce one or more electrical signals representative of communications received from an external processor (internal processor 185 receives communications from external processing components 175/180 via antenna 187, Fig. 2; Paragraph 0025-0026, 0029);
and an interposer (hermetic feedthrough connector 401 in case 400 and associated components, Figs. 4-5; Paragraph 0030-0033, 0036, 0039) electrically coupled to the first electrical lead (190, Fig. 3; Paragraph 0029, 0026, 0032) and the auditory signal device (internal processor 185, Fig. 3, 5C; Paragraph 0026, 0029, 0048) to enable one or more electrical signals produced by the auditory signal device to be transmitted through the first electrical lead to the implantable electrode array (“the larger hermetic feedthrough (401) provides electrical connections between the electrodes in the cochlear lead and the internal electronics that are housed in the case”, Paragraph 0032; see also Paragraphs 0034-0041).
Regarding Claim 2, Koester discloses an auditory nerve stimulation system further wherein the interposer (hermetic feedthrough connector 401 in case 400 and associated components, Figs. 4-5) is formed of a ceramic material (ceramic components, Paragraph 0031, 0034).
Regarding Claim 13, Koester discloses an auditory nerve stimulation system further wherein the implantable electrode array (electrodes in array, 195, Fig. 3; Paragraph 0029) extends between a first end and an opposite second end (see electrode array in Figs. 1 and 3) and includes a first handling feature defined by an elongated pin (see elongated spiral wire pin in Fig. 1 extending from end of array 195 in cochlear section 150; Paragraph 0022, 0026) extending transversely from the first end.
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.
Claims 3-7 are rejected under 35 U.S.C. 103 as being unpatentable over Koester (US Publication No. 2012/0016444) in view of Boling et al. (US Publication No. 2010/0274313).
Regarding Claims 3 and 4, Koester discloses an auditory nerve stimulation system further wherein the auditory signal device (internal processor 185, Fig. 3, 5C; Paragraph 0026, 0029, 0048) includes electrical connectors (ribbon vias 404 connected to circuit board connections 535, Fig. 4, 5C; Paragraph 0048, 0052), and the interposer is configured to receive and electrically couple with the electrical connectors (Paragraph 0037, 0040, 0048, 0052; see connections of Fig. 5C), wherein the interposer includes contact pads (interconnection contacts 505 connected to other side of ribbon vias 404 with groove connection 510, Figs. 4-5; Paragraphs 0037, 0040-0041, 0049, 0053) and each of the contact pads (interconnection contacts 505 connected to other side of ribbon vias 404 with groove connection 510, Figs. 4-5; Paragraphs 0037, 0040-0041, 0049, 0053) provides a coupling location for a respective wire of the first electrical lead (190, Fig. 3; Paragraph 0029, 0032, 0042; see 525, Fig. 5C, Paragraph 0053) and a respective electrical connector wire (individual ribbon vias 404 on both sides of feedthrough connector through 412, which are connected to circuit board connections 535 inside case 400, Fig. 4, 5A-5C; Paragraph 0048, 0052) which extends to a respective one of the electrical connectors (Paragraph 0030, 0040-0041, 0052-0053, see Figs. 4, 5A-5C).
Koester discloses that the electrical connectors are in the form of ribbon vias (404, Fig. 4, 5C) and circuit board connectors (535, Fig. 5C; Paragraph 0048, 0052), however, does not explicitly disclose electrical pin connectors. Boling et al. teaches an implantable nerve stimulation system (Abstract) comprising an interposer (Paragraph 0062-0065) wherein electrical connections comprise conductive feed-through pins (Paragraph 0064; see pins of Fig. 9) to connect wires to the integrated circuit (ASIC, Paragraph 0062).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to configure the electrical connectors as disclosed by Koester to be in the form of pins, as taught by Boling et al., in order to securely and conductively connect the components, since such a modification would have involved a mere change in the form or shape of the connection components. A change in form or shape is generally recognized as being within the level of ordinary skill in the art. In re Dailey, 149 USPQ 47 (CCPA 1976).
Regarding Claims 5, 6, and 7, Koester discloses an auditory nerve stimulation system further wherein the respective wire of the first electrical lead (190, Fig. 3; Paragraph 0029, 0032, 0042; see 525, Fig. 5C, Paragraph 0053) is formed of a first material or a first combination of materials (e.g. conductive materials, silicone, rubber, etc., Paragraph 0062, 0053-0054, 0029) and the respective electrical connector wire (individual ribbon vias 404 on both sides of feedthrough connector through 412, which are connected to circuit board connections 535 inside case 400, Fig. 4, 5A-5C; Paragraph 0048, 0052) is formed of a second material or a second combination of materials (e.g. platinum, gold, alloy, Paragraph 0036-0037, 0039, 0049, 0061), wherein each of the contact pads (interconnection contacts 505 connected to other side of ribbon vias 404 with groove connection 510, Figs. 4-5; Paragraphs 0037, 0040-0041, 0049, 0053) is formed of a material which is the same as the first material or one of the materials of the first combination of materials or is the same as the second material or one of the materials of the second combination of materials (e.g. conductive material, platinum, gold, alloy, Paragraph 0039, 0049, 0053).
Koester discloses that the electrical connectors are in the form of ribbon vias (404, Fig. 4, 5C) and circuit board connectors (535, Fig. 5C; Paragraph 0048, 0052), however, does not explicitly disclose electrical pin connectors. Boling et al. teaches an implantable nerve stimulation system (Abstract) comprising an interposer (Paragraph 0062-0065) wherein electrical connections comprise conductive feed-through pins (Paragraph 0064; see pins of Fig. 9) to connect wires to the integrated circuit (ASIC, Paragraph 0062). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to configure the electrical connectors as disclosed by Koester to be in the form of pins, as taught by Boling et al., in order to securely and conductively connect the components, since such a modification would have involved a mere change in the form or shape of the connection components. A change in form or shape is generally recognized as being within the level of ordinary skill in the art. In re Dailey, 149 USPQ 47 (CCPA 1976).
Furthermore, Koester does disclose that the contact pads may be formed of platinum (Paragraph 0049) and that components of the connections may be formed of gold (Paragraph 0036, 0061). Koester does not explicitly disclose wherein the respective wire of the first electrical lead is formed of gold, and the respective electrical connector wire is formed of a combination of platinum and iridium.
Boling et al. teaches an implantable nerve stimulation system (Abstract) comprising an interposer (Paragraph 0062-0065) wherein electrical connections comprise wires formed of gold (e.g. gold braze, Paragraph 0051, 0053, 0055, 0063) and electrical pins/wires formed of a combination of platinum and iridium (platinum/ iridium tubing, Paragraph 0051, 0055, 0066, 0067; Claim 17). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to configure the respective wire of the first electrical lead to be formed of gold, and the respective electrical connector wire to be formed of a combination of platinum and iridium, as taught by Boling et al., in the system disclosed by Koester, since these are known suitable electrical connection materials, and since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416. Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Koester (US Publication No. 2012/0016444) in view of Yakolev et al. (US Publication No. 2017/0095667).
Regarding Claim 8, Koester discloses an auditory nerve stimulation system further wherein a first electrical lead (190, Fig. 3; Paragraph 0029, 0026, 0032) is electrically coupled to and extending from the implantable electrode array (195, Fig. 3); wherein the interposer includes contact pads (interconnection contacts 505 connected to other side of ribbon vias 404 with groove connection 510, Figs. 4-5; Paragraphs 0037, 0040-0041, 0049, 0053) and each of the contact pads (interconnection contacts 505 connected to other side of ribbon vias 404 with groove connection 510, Figs. 4-5; Paragraphs 0037, 0040-0041, 0049, 0053) provides a coupling location for a respective wire of the first electrical lead (190, Fig. 3; Paragraph 0029, 0032, 0042; see 525, Fig. 5C, Paragraph 0053).
However, Koester does not explicitly disclose wherein the auditory signal device includes a second electrical lead extending therefrom and the interposer includes contact pads each providing a coupling location for a respective wire of the first electrical lead and a respective wire of the second electrical lead.
Yakolev et al. discloses an implantable nerve stimulation system (Abstract, Paragraph 0317) including a first and second electrical lead (multiple leads, Paragraph 0065, 0070, 0077, 0099, 0313) and an interposer (Paragraph 0338, 0340-0341) includes contact pads each providing a coupling location for a respective wire of the first electrical lead and a respective wire of the second electrical lead (multiple leads with multiple connections/contacts in connector hub, Paragraph 0077, 0106, 0313; Claim 309)
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to configure the nerve stimulation system disclosed by Koester to have a second electrical lead with respective connections/coupling locations, as taught by Yakolev et al., in order to allow for stimulation in multiple target areas and/or to provide different stimulation programs with the multiple different leads, since it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960).
Claims 9 and 15-16 are rejected under 35 U.S.C. 103 as being unpatentable over Koester (US Publication No. 2012/0016444) in view of Clark et al. (US Publication No. 2009/0283425).
Regarding Claims 9, 15, and 16, Koester discloses an auditory nerve stimulation system further wherein the first electrical lead (190, Fig. 3; Paragraph 0029, 0026, 0032) includes a plurality of wires (Paragraph 0062, 0053-0054, 0029) and one or more of the plurality of wires is individually and electrically coupled with a respective one of the plurality of electrodes in the electrode array (electrodes in array, 195, Fig. 3; Paragraph 0029, 0053), wherein the electrodes in the implantable electrode array are arranged in a grid including a number of rows (195, Figs. 1, 3; Paragraph 0053).
However, Koester does not explicitly disclose wherein the electrodes comprise a plurality of micro-needles, wherein a length of each micro-needle in a respective row is different than a length of each micro-needle in a different row. Clark et al. teaches an implantable nerve stimulation system (Paragraph 0035, 0044; Abstract) comprising electrodes which comprise a plurality of micro-needles (12, Figs. 2a-c; Paragraph 0032, 0035, 0037), where the plurality of micro-needles of the implantable electrode array are arranged in a grid including a number of rows (see rows of micro-needles 12, Figs. 2a-c; Paragraph 0032, 0035, 0037), and wherein a length of each micro-needle in a respective row is different than a length of each micro-needle in a different row (micro-needle electrodes vary in height, Paragraph 0035, 0041; see Figs. 2b-c; Claims 7 and 8).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to configure the electrodes in the nerve stimulation system disclosed by Koester to be micro-needles, wherein a length of each micro-needle in a respective row is different than a length of each micro-needle in a different row, as taught by Clark et al., since “variation in height in the electrodes can increase the number of signals that can be sensed and the types of tissue that can be stimulated using the array when it is interfaced with tissue within a body, such as a muscle, a nerve, the brain, and so forth” (see Clark et al., Paragraph 0035). Furthermore, such a modification of the electrodes and array into needles with varying heights would have involved a mere change in the form or shape of the electrode components. A change in form or shape is generally recognized as being within the level of ordinary skill in the art. In re Dailey, 149 USPQ 47 (CCPA 1976).
Furthermore, although Clark et al. does teach that a length of each micro-needle in a respective row is different than a length of each micro-needle in a different row (micro-needle electrodes vary in height, Paragraph 0035, 0041; see Figs. 2b-c; Claims 7 and 8), however, neither Koester nor Clark et al. teach explicitly wherein the length of each electrode/micro-needle ranges from about 0.1 millimeters to about 1.2 millimeters. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to configure the length of each electrode/micro-needle to be about 0.1 millimeters to about 1.2 millimeters, in order to accurately interface with specific target tissue (e.g. see Clark et al., Paragraph 0035), since such a modification would have involved a mere change in the size of a component. A change in size is generally recognized as being within the level of ordinary skill in the art. In re Rose, 105 USPQ 237 (CCPA 1955).
Claims 10-12 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Koester (US Publication No. 2012/0016444) in view of Leigh (US Publication No. 2018/0056067).
Regarding Claims 10-12, Koester discloses an auditory nerve stimulation system further wherein the first electrical lead (190, Fig. 3; Paragraph 0029, 0026, 0032) includes a plurality of wires (Paragraph 0062, 0053-0054, 0029), a first portion and a second portion (multiple portions/sections of lead/wires, 190 connected to ribbon vias and electrodes, Figs. 3, 5A-C; Paragraph 0029, 0026, 0032, 0049, 0053) positioned between the first portion and the implantable electrode array (electrodes in array, 195, Fig. 3; Paragraph 0029, 0053), and in the second portion comprises a bendable portion (flexible components/materials, Paragraph 0029, 0051) and the plurality of wires are linearly arranged (see Figs. 3, 5A-C; Paragraph 0029, 0026, 0032, 0041), wherein the bendable portion comprises one or more platinum wires (platinum components of wires/connections, Paragraph 0029, 0037, 0039, 0049, 0060; Claims 22 and 23). However, Koester does not explicitly disclose wherein in the first portion, the plurality of wires are helically arranged.
Leigh teaches an auditory nerve stimulation system (Abstract, Paragraph 0006) comprising an electrical lead with a plurality of wires (electrical lead wires 189, Figs. 1-2), wherein in a first portion, the plurality of wires are helically arranged (helix region 182 of wires 189, Fig. 1B, 2; Paragraph 0034-0035). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to configure the plurality of wires in the first portion to be helically arranged, as taught by Leigh, in the lead of the nerve stimulation system disclosed by Koester, in order to provide added strength/flexibility of the connection components, since such a modification would have involved a mere change in the form or shape of the wires. A change in form or shape is generally recognized as being within the level of ordinary skill in the art. In re Dailey, 149 USPQ 47 (CCPA 1976).
Regarding Claim 14, Koester discloses an auditory nerve stimulation system further wherein the implantable electrode array (electrodes in array, 195, Fig. 3; Paragraph 0029) extends between a first end and an opposite second end (see electrode array in Figs. 1 and 3) and includes a first handling feature defined by an elongated pin (see elongated spiral wire pin in Fig. 1 extending from end of array 195 in cochlear section 150; Paragraph 0022, 0026) extending transversely from the first end. However, Koester does not explicitly disclose wherein the lead further includes a second handling feature defined by a handle extending from and connecting to the first electrical lead at discrete locations.
Leigh teaches an auditory nerve stimulation system (Abstract, Paragraph 0006) comprising an electrical lead with a plurality of wires (electrical lead wires 189, Figs. 1-2), wherein the lead includes a handling feature (nubs 187 on outer surface of array, Figs. 1B-2; Paragraph 0034) defined by a handle extending from and connecting to the lead at discrete locations (Paragraph 0034).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to include a second handling feature defined by a handle extending from and connecting to the first electrical lead at discrete locations, as taught by Leigh, in the lead of the nerve stimulation system disclosed by Koester, in order to allow for easier/more accurate implantation, since Leigh also teaches “nubs 187 are provided on the outer surface of the proximal region to aid in the manipulation of the electrode array assembly 190 during insertion of the intra-cochlear region into the cochlea” (Paragraph 0034).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PAMELA M BAYS whose telephone number is (571)270-7852. The examiner can normally be reached 9:00am - 6:00pm EST.
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/PAMELA M. BAYS/Primary Examiner, Art Unit 3796