The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
DETAILED ACTION
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the single-use applicator (claim 29) must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The disclosure is objected to because of the following informalities: Paragraph [0001] recites related application 15/164789 which has now matured into a patent the paragraph should be updated to include the issued patent number.
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 21, 23 and 26-28 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 21 recites the limitation "the impedance" in line 2. There is insufficient antecedent basis for this limitation in the claim. Claim 23 recites the limitation "the conductive material" in line 2. There is insufficient antecedent basis for this limitation in the claim. Claim 23 recites “and the electrodes” it is unclear which “electrodes” applicant is referring to when reciting “the electrodes” since multiple electrodes including an “electrode assembly” and “two electrodes” have previously been recited, clarification is required Claim 26 recites the limitation "the impedance" in line 2. There is insufficient antecedent basis for this limitation in the claim. Claim 27 recites the limitation "the impedance" in line 2. There is insufficient antecedent basis for this limitation in the claim. Claim 27 recites “an electrode of the electrodes” it is unclear which “electrodes” applicant is referring to when reciting “the electrodes” since multiple electrodes including an “electrode assembly” and “two electrodes” have previously been recited, clarification is required. Claim 28 recites the limitation "the electrode array" in line 5. There is insufficient antecedent basis for this limitation in the claim. Claim 28 recites “and implanting the electrode array if the termination is to implant the electrode array” it is unclear what “termination” applicant is using or referring to to implant the electrode array, clarification is required. As best understood, for the purposes of examination, claim 23 has been interpreted to include a fluid that is a conductive material between the package and the electrode assembly.
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.
Claim(s) 1,3 and 8 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 2003/0055478 to Lyster et al. (Lyster) (cited by applicant).
In reference to at least claim 1
Lyster discloses a sterilely sealed package (e.g. 450); and an electrode assembly sterilely sealed in the package (e.g. 150), wherein the apparatus is configured to enable testing for an open circuit between two electrodes of the electrode assembly with the electrode assembly sterilely sealed in the package (e.g. paragraphs [0127],[0130],[0142],[0148],[0153],[0169]; it is disclosed that the electrodes upon their release liner are sealed in a package and that the cartridge facilitates high-reliability sealing of mounted electrodes within an environment that has well-defined conditions in which moisture transfer into and out of the rigid cartridge is minimized, eliminated or essentially eliminated, therefore the electrodes are sterilely sealed within the package, paragraphs [0007], [0126]).
In reference to at least claim 3
Lyster discloses the apparatus provides conductivity between two electrodes of the electrode assembly sufficient to enable testing for an open circuit between the two electrodes while also enabling testing for a short circuit between the two electrodes with the conductivity present between the two electrodes (e.g. cartridge is coupled to the electrodes to test for short or open circuits, paragraphs [0127], [0130], [0142], [0148], [0153], [0169]).
In reference to at least claim 8
Lyster discloses wherein at least a portion of the package is made of a conductive material in direct contact with electrodes of the electrode assembly (e.g. release liners within the packaging contains conductive gel layer, paragraph [0099],[0127] and cartridge is coupled to the electrodes to test for short or open circuits, paragraphs [0125],[0127]).
Claim(s) 17 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US Patent No. 4,522,209 to Patrick et al. (Patrick) (cited by applicant)
In reference to at least claim 17
Patrick discloses an apparatus, comprising: a package (e.g. sterile container, 14, Col. 1, ll. 54-63, Col. 4, ll. 21-34); and an electrode assembly sterilely sealed in the package (e.g. electrode 11 consists of a number of platinum bands or rings 12, Fig. 1, Col. 2, ll. 51-63; sealed within sterile container, 14, Col. 1, ll. 54-63, Col. 4, ll. 21-34), wherein the apparatus is configured to provide electrical conductivity between two electrodes of the electrode assembly (e.g. Col. 4, ll. 3-43).
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 1-3,8-12, 14,17, 20, 22-25 and 29-33 is/are rejected under 35 U.S.C. 103 as being unpatentable over US Patent No. 6,116,413 to Tabor et al. (Tabor) in view of US Patent No. 4,522,209 to Patrick et al. (Patrick) (both cited by applicant).
In reference to at least claim 1
Tabor discloses a sealed package (e.g. 11); and an electrode assembly sealed in the package (e.g. 15), wherein the apparatus is configured to enable testing for an open circuit between two electrodes of the electrode assembly with the electrode assembly sealed in the package immediately after packaging and immediately prior to implantation (e.g. Col. 1, ll. 29-32, 41-46, Col. 2, ll. 47-53). Tabor discloses that the packing system (e.g. 11) includes a tube that includes the electrodes and the liquid used for testing (e.g. 13) which is sealed (e.g. Col. 2, ll. 47-53) and further discloses the container or tube being permeable to a sterilizing medium such as ETO/steam (Col. 2, ll. 33-35). It was well known in the art before the effective filing date of the invention to sterilize the package at the manufacturing plant and then ship the sterilized sealed package to the hospital or medical center where the surgery is to be performed as evidence by Patrick (e.g. Col. 1, ll. 40-63); therefore it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to sterilized the package of Tabor at the manufacturing plant and then ship the sterilized sealed package to the hospital or medical center as such technique of sterilizing at the manufacturing plant and providing a sterilized sealed package to the hospital or medical center was well known and provides the predictable result of a ready to use prosthesis that will not have to be sterilized again before implantation.
In reference to at least claim 2
Tabor discloses the electrode assembly is in a state prepared for direct implantation into a recipient upon opening of the package (e.g. electrode array is ready for implantation upon opening of the package, Fig. 2).
In reference to at least claim 3
Tabor discloses the apparatus provides conductivity between two electrodes of the electrode assembly sufficient to enable testing for an open circuit between the two electrodes while also enabling testing for a short circuit between the two electrodes with the conductivity present between the two electrodes (e.g. tested for continuity between electrodes, Col. 3, ll. 11-15).
In reference to at least claim 8
Tabor discloses wherein at least a portion of the package is made of a conductive material in direct contact with electrodes of the electrode assembly (e.g. conductive biocompatible and bioresorbable liquid, abstract, Col. 1, ll. 53-57).
In reference to at least claim 9
Tabor discloses obtaining an electrode assembly isolated from an external environment thereof (e.g. 15); and testing for an open circuit between two electrodes of the electrode assembly while the electrode assembly is sealed from the external environment (e.g. Col. 2, ll. 51-53). Tabor discloses that the packing system (e.g. 11) includes a tube that includes the electrodes and the liquid used for testing (e.g. 13) which is sealed (e.g. Col. 2, ll. 47-53) and further discloses the container or tube being permeable to a sterilizing medium such as ETO/steam (Col. 2, ll. 33-35). It was well known in the art before the effective filing date of the invention to sterilize the package at the manufacturing plant and then ship the sterilized sealed package to the hospital or medical center where the surgery is to be performed as evidence by Patrick (e.g. Col. 1, ll. 40-63); therefore it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to sterilized the package of Tabor at the manufacturing plant and then ship the sterilized sealed package to the hospital or medical center as such technique of sterilizing at the manufacturing plant and providing a sterilized sealed package to the hospital or medical center was well known and provides the predictable result of a ready to use prosthesis that will not have to be sterilized again before implantation.
In reference to at least claim 10
Tabor discloses eliminating the sterile isolation after testing and implanting the electrode assembly in a human recipient (e.g. electrode array is ready for implantation upon opening of the package, Fig. 2).
In reference to at least claim 11
Tabor discloses the action of implanting the electrode assembly includes implanting the electrode assembly into the human recipient after eliminating the sterile isolation without adding material to or removing material from the implantable assembly (e.g. electrode array is ready for implantation upon opening of the package, Fig. 2).
In reference to at least claim 12
Tabor discloses the action of testing for an open circuit includes testing for the open circuit while the recipient is under anesthesia and prepared for implantation; and the method further includes determining whether to implant the electrode assembly in the recipient based on the testing (e.g. the invention overcome the above disadvantages including allowing testing immediately prior to implantation of the device, Col. 1, ll. 29-33,41-46).
In reference to at least claim 14
Tabor discloses manipulating package material forming the sterile isolation from a first state to a second state and subsequently testing for one of the open circuit or a short circuit of the electrode assembly while the electrode assembly is sterilely isolated from the ambient environment (e.g. tested for continuity between electrodes using limited current, Fig. 3, Col. 3, ll. 11-15; claim 15).
In reference to at least claim 17
Tabor discloses a package (e.g. 11); an electrode assembly sealed in the package (e.g. 15), wherein the apparatus is configured to provide electrical conductivity between two electrodes of the electrode assembly (e.g. “Liquid 17 is held in container or tube 13 by surface tension. However, preferably the liquid is held within the container by a seal 24 around the sleeve 23 which is impermeable to the liquid. Alternatively, a larger container may be used for housing the complete electrode assembly. Of most importance is for liquid 17 to be conductive so that electrode array 15 can be tested for open circuits after packaging within system 11 as described below.”, Col. 1, ll. 29-32, 41-46, Col. 2, ll. 47-53). Tabor discloses that the packing system (e.g. 11) includes a tube that includes the electrodes and the liquid used for testing (e.g. 13) which is sealed (e.g. Col. 2, ll. 47-53) and further discloses the container or tube being permeable to a sterilizing medium such as ETO/steam (Col. 2, ll. 33-35). It was well known in the art before the effective filing date of the invention to sterilize the package at the manufacturing plant and then ship the sterilized sealed package to the hospital or medical center where the surgery is to be performed as evidence by Patrick (e.g. Col. 1, ll. 40-63); therefore it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to sterilized the package of Tabor at the manufacturing plant and then ship the sterilized sealed package to the hospital or medical center as such technique of sterilizing at the manufacturing plant and providing a sterilized sealed package to the hospital or medical center was well known and provides the predictable result of a ready to use prosthesis that will not have to be sterilized again before implantation.
In reference to at least claim 20
Tabor discloses the apparatus is configured to vary an impedance between electrodes of the electrode assembly to have a value less than 90 ohms to have a value more than 2000 ohms (e.g. “ Liquid 17 is held in container or tube 13 by surface tension. However, preferably the liquid is held within the container by a seal 24 around the sleeve 23 which is impermeable to the liquid. Alternatively, a larger container may be used for housing the complete electrode assembly. Of most importance is for liquid 17 to be conductive so that electrode array 15 can be tested for open circuits after packaging within system 11 as described below.” Col. 2, ll. 44-60, the apparatus contains a saline fluid within the package enabling varying of impedance including less than 90 ohms to more than 2000 ohms).
In reference to at least claim 22
Tabor discloses a concentration of saline establishes a conductive path between a first electrode of the two electrodes and a second electrode of the two electrodes, thereby enabling testing for an open circuit between the two electrodes (e.g. “ Liquid 17 is held in container or tube 13 by surface tension. However, preferably the liquid is held within the container by a seal 24 around the sleeve 23 which is impermeable to the liquid. Alternatively, a larger container may be used for housing the complete electrode assembly. Of most importance is for liquid 17 to be conductive so that electrode array 15 can be tested for open circuits after packaging within system 11 as described below.” Col. 2, ll. 44-60, the apparatus contains a saline fluid enabling testing for open circuits)., the concentration of saline being sterilely isolated from the external environment (e.g. “liquid 17 is held in container or tube 13 by surface tension. However, preferably the liquid is held within the container by a seal 24 around the sleeve 23 which is impermeable to the liquid.”, col. 2, ll. 44-49).
In reference to at least claim 23
Tabor discloses wherein: a fluid is located in the sterilely sealed package between the package and the electrodes (e.g. liquid 17), which fluid is the conductive material (e.g. “The preferred liquid 17 is saline-doped glycerol, i.e., a solution of 1% sodium chloride in glycerol, since it is substantially conductive and is more pliable than polyvinyl alcohol.”, Col. 2, ll. 44-60).
In reference to at least claim 24
Tabor discloses wherein: a conductive material is located between a first electrode of the two electrodes and a second electrode of the two electrodes (e.g. “As can be appreciated, liquid 17 coats or otherwise bathes electrode array 15 as it is situated in container 13.”, Col. 2, ll. 36-41); and the electrode assembly is part of an implantable medical device (e.g. “A cochlear device is generally understood to be some type of implantable hearing aid which helps a specific class of patients for which conventional hearing aids are inadequate. As is well known, a cochlear device includes an electrode array of one or more electrodes which must perform appropriately for the device to function.”, Col. 2, ll. 14-20).
In reference to at least claim 25
Tabor discloses adjusting an impedance between a first electrode of the two electrodes and a second electrode of the two electrodes while the electrode assembly is sterilely sealed from the external environment (e.g. “ Liquid 17 is held in container or tube 13 by surface tension. However, preferably the liquid is held within the container by a seal 24 around the sleeve 23 which is impermeable to the liquid. Alternatively, a larger container may be used for housing the complete electrode assembly. Of most importance is for liquid 17 to be conductive so that electrode array 15 can be tested for open circuits after packaging within system 11 as described below.” Col. 2, ll. 44-60, the apparatus contains a saline fluid within the package enabling varying of impedance), wherein the action of testing for an open circuit includes doing so before or after the action of adjusting of the impedance (e.g. “ Liquid 17 is held in container or tube 13 by surface tension. However, preferably the liquid is held within the container by a seal 24 around the sleeve 23 which is impermeable to the liquid. Alternatively, a larger container may be used for housing the complete electrode assembly. Of most importance is for liquid 17 to be conductive so that electrode array 15 can be tested for open circuits after packaging within system 11 as described below.” Col. 2, ll. 44-60, the apparatus contains a saline fluid within the package enabling varying of impedance).
In reference to at least claim 29
Tabor discloses the apparatus is configured to enable open circuit testing via a single use applicator (e.g. testing is enabled while the electrodes are contained in the sealed package, Col. 2, ll. 51-53). Additionally, Tabor discloses that providing packages that allow a “only once” test for open circuits is known within the art (e.g. Col. 1, ll. 20-29), therefore enabling a system that enables open circuit testing via a single use applicator would have been obvious to one having ordinary skill in the art before the effective filing date of the invention as such technique was well-known in order to yield the predictable resulting of providing for testing electrodes before use as disclosed by Tabor.
In reference to at least claim 30
Tabor discloses the apparatus is configured to apply current to one of a plurality of leads respectively leading to respective electrodes, the respective electrodes including the two electrodes; and the apparatus is configured to detect current at another of the plurality of leads if there is no open circuit (e.g. “Since all the electrodes are bathed in the liquid 17, they are effectively shorted to each other. Therefore, the electrodes can be easily tested for continuity. For example, as shown in FIG. 3, each electrode and its conductor can be tested by checking the continuity between 21A, 21B . . . and 21D, which may be considered a common return.”, Col. 3, ll. 10-15).
In reference to at least claim 31
Tabor discloses the apparatus is configured enable two types of conductivity testing of the electrode assembly (e.g. “it cannot be conducted both immediately alter packaging and immediately prior to implantation if the "elapsed" time were sufficient to allow water evaporation… Accordingly, it would be desirable to provide a packaging system that overcomes the above disadvantages. Furthermore, multiple electrodes are used in other biomedical applications as well and it would be desirable to provide a packaging which could be used for these other types of electrodes as well.” Col. 1, ll. 29-46, enables conductivity testing immediately after packaging which is one type and immediately prior to implantation which is another type.) .
In reference to at least claim 32
Tabor discloses the electrode assembly is in a state prepared for direct implantation into a recipient upon opening of the package (e.g. electrode array is ready for implantation upon opening of the package, Fig. 2).
In reference to at least claim 33
Tabor discloses the fluid is saline (e.g. “The preferred liquid 17 is saline-doped glycerol, i.e., a solution of 1% sodium chloride in glycerol, since it is substantially conductive and is more pliable than polyvinyl alcohol.”, Col. 2, ll. 44-60).
Claims 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over US Patent No. 6,116,413 to Tabor et al. (Tabor) in view of US Patent No. 4,522,209 to Patrick et al. (Patrick) as applied to claim 1 further in view of US 2015/0142073 to Taff et al. (Taff) (cited by applicant)
In reference to at least claim 6
Tabor as evidence by Patrick teaches an apparatus according to claim 1 but does not explicitly teach an electrically conductive foam portion that is in electrical contact with two electrodes of the electrode assembly.
Taff teaches a sterilizable containment for implantable medical device which discloses an inner packaging that includes an electric conducting medium that can include a fluid or liquid gel or a conductive foam (e.g. paragraphs [0025],[0069]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the device of Tabor as evidence by Patrick with the teachings of Taff to include instead of using a conductive fluid or liquid gel to use a conductive foam in order to provide the predictable result of a conducting medium that is more solid to reduce any potential leakage of the conducting material from the package of the device.
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 1-3,6, 8-12,14,17,20 and 26 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2,4-11,20 and 22 of U.S. Patent No.11,660,445. Although the claims at issue are not identical, they are not patentably distinct from each other because both the claims in the instant application and U.S. Patent No.11,660,445 recite almost identical apparatuses and method that include a sterilely sealed package with electrode assembly sealed within the package. The claims in the instant application are generic and fully anticipated by the claims within U.S. Patent No.11,660,445, see claim chart below. The entire scope of claims 1-3,6-12,14,17,20 and 26 in the instant application falls within the scope of claims 1-2,4-11,20 and 22 of U.S. Patent No.11,660,445, therefore a patent to the generic claims within the instant application would improperly extend the right to exclude granted by U.S. Patent No.11,660,445, see MPEP 804. See claim chart below to see where limitations within the instant claims are disclosed within U.S. Patent No.11,660,445.
Instant Application
US Patent No. 11,660,445
Claim 1
1. An apparatus, comprising: a sterilely sealed package; and an electrode assembly sterilely sealed in the package, wherein the apparatus is configured to enable testing, with a conductive material, for an open circuit between two electrodes of the electrode assembly with the electrode assembly sterilely sealed in the package, wherein the apparatus is configured to disable the enablement of the testing for the open circuit while the electrode assembly is sterilely sealed in the package.
Claim 2
2. The apparatus of claim 1, wherein: the electrode assembly is in a state prepared for direct implantation into a recipient upon opening of the package.
Claim 3
4. The apparatus of claim 1, wherein: the apparatus provides conductivity between two electrodes of the electrode assembly sufficient to enable testing for an open circuit between the two electrodes while also enabling testing for a short circuit between the two electrodes with the conductivity present between the two electrodes.
Claim 6
5. The apparatus of claim 4, wherein the apparatus includes an electrically conductive foam portion that directly contacts the two electrodes.
Claim 8
6. The apparatus of claim 1, wherein at least a portion of the package is made of the conductive material and is in direct contact with electrodes of the electrode assembly.
Claim 9
7. A method, comprising: obtaining an electrode array within a sealed package sterilely isolated from an external environment thereof; testing, with a conductive material, for an open circuit between two electrodes of the electrode array while the electrode array is sterilely isolated from the external environment within the sealed package; and testing for a short circuit in the electrode array while the electrode array is sterilely isolated from the external environment within the sealed package.
Claim 10
8. The method of claim 7, further comprising: eliminating the sterile isolation after testing and implanting the electrode array in a human recipient.
Claim 11
9. The method of claim 8, wherein: the action of implanting the electrode array includes implanting the electrode array into the human recipient after eliminating the sterile isolation without adding material to or removing material from the electrode array.
Claim 12
10. The method of claim 8, wherein: the action of testing for an open circuit includes testing for the open circuit while the recipient is under anesthesia and prepared for implantation; and the method further includes determining whether to implant the electrode array in the recipient based on the testing.
Claim 14
11. The method of claim 7, further comprising: manipulating package material forming the sterile isolation from a first state to a second state and subsequently testing for one of the open circuit or the short of the electrode array while the electrode array is sterilely isolated from the external environment.
Claim 17
20. An apparatus, comprising: a package; and an electrode array sterilely sealed in the package, wherein the apparatus is configured to provide electrical conductivity between two electrodes of the electrode array with a conductive material, wherein at least one of: the apparatus is configured to alternately provide and eliminate the electrical conductivity between the two electrodes, with the conductive material, while sterilely sealed in the package; or the apparatus is configured to vary an impedance between electrodes of the electrode array from more than 1000 ohms to less than 100 ohms, with the conductive material, while sterilely sealed in the package.
Claim 20
20. An apparatus, comprising: a package; and an electrode array sterilely sealed in the package, wherein the apparatus is configured to provide electrical conductivity between two electrodes of the electrode array with a conductive material, wherein at least one of: the apparatus is configured to alternately provide and eliminate the electrical conductivity between the two electrodes, with the conductive material, while sterilely sealed in the package; or the apparatus is configured to vary an impedance between electrodes of the electrode array from more than 1000 ohms to less than 100 ohms, with the conductive material, while sterilely sealed in the package.
22. The apparatus of claim 20, wherein: the apparatus is configured to vary an impedance between electrodes of the electrode array from more than 1000 ohms to less than 100 ohms, with the conductive material, while sterilely sealed in the package.
Claim 26
20. An apparatus, comprising: a package; and an electrode array sterilely sealed in the package, wherein the apparatus is configured to provide electrical conductivity between two electrodes of the electrode array with a conductive material, wherein at least one of: the apparatus is configured to alternately provide and eliminate the electrical conductivity between the two electrodes, with the conductive material, while sterilely sealed in the package; or the apparatus is configured to vary an impedance between electrodes of the electrode array from more than 1000 ohms to less than 100 ohms, with the conductive material, while sterilely sealed in the package.
22. The apparatus of claim 20, wherein: the apparatus is configured to vary an impedance between electrodes of the electrode array from more than 1000 ohms to less than 100 ohms, with the conductive material, while sterilely sealed in the package.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JENNIFER L GHAND whose telephone number is (571)270-5844. The examiner can normally be reached on Mon-Fri 7:30AM - 3:30PM ET.
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/JENNIFER L GHAND/Examiner, Art Unit 3796