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 .
Amendment
This action is in response to the Amendment filed on 5/14/2026.
Claims 1-4, 6, 11, 13, 14, 32, 34-41, 43-45 and 50-55 are pending.
Response to Arguments
Applicant's arguments filed 5/14/2026 have been fully considered but they are not persuasive.
Claim Rejection Under 0112, Second Paragraph
In view of the amendment, the rejection has been withdrawn.
Claim Rejections Under 35 U.S.C. 101
Applicant’s arguments and the amendments have been considered. However, they are not persuasive for the following reasons. The claims rejected under 35 U.S.C. 101 are directed to an apparatus not a method. Applicant recites part of a human (Note: mammal encompasses a human) , i.e. “… the electrode is at least one of directly or indirectly fixed to an otic capsule or tissue associated with the otic capsule of a mammal at least in part with cured securement material” (Claim 1, lines 2-4) “…the electrode is fixed to the promontory of a cochlea of the mammal (Claim 2 line 2) “the electrode is located in an artificial hole in the otic capsule”( claim 3) , “the electrode is in direct or indirect contact with a round window of a cochlea of the mammal (claim 4 line 2-3).
Congress has excluded claims directed to or encompassing a human organism from patentability. The Leahy-Smith America Invents Act (AIA ), Public Law 112-29, sec. 33(a), 125 Stat. 284, states: Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism. (Please see MPEP Section 2105(III)).
Thus, these claims include a human within the scope and are non-statutory. A claim directed to or including within its scope a human is not considered to be patentable subject matter under 35 U.S.C. 101. The grant of a limited, but exclusive property right in a human being is prohibited by the Constitution. In re Wakefield, 422 F.2d 897, 164 USPQ 636 (CCPA 1970). The examiner suggests using the phrase "adapted to be fixed/located/in direct or indirect contact" when referring to the location of the electrode in relation to the body part. Therefore, the rejection is maintained. The dependent claims inherit the deficiency.
Claim Rejections Under 35 U.S.C. 103
Applicant’s arguments have been reviewed and are not persuasive for the following reasons.
Claim 1 recites:
1. An apparatus, comprising:
an electrode, wherein the electrode is at least one of directly or indirectly fixed to an otic capsule or tissue associated with the otic capsule of a mammal at least in part with cured securement material.
Firstly, this claim is directed to an apparatus that comprises an electrode. The language “wherein the electrode is at least one of directly or indirectly fixed to an otic capsule or tissue associated with the otic capsule of a mammal at least in part with cured securement material” is intended use. these limitations are directed to where the electrode is implanted and how it fixed to the otic capsule as recited in the apparatus claim 1. The claim is just an apparatus comprising an electrode and therefore broadly interpreted, the apparatus that comprises an electrode could be ANY electrode since there is no structure being claimed for the electrode. However, for the sake of compact prosecution and for consistency with the method claim 40, the claim was rejected with the teachings of Shalev in view of Kroll. Shalev teaches an apparatus comprising an electrode (e.g. 440 Fig. 4, [0157]). Shalev further teaches that the electrode is at least one of directly or indirectly fixed to an otic capsule or tissue associated with the otic capsule of a human (e.g. [0083]-0089]: electrode placed near the fenestra rotunda, [0157]: The electrode 440 is placed adjacent to the cochlear window 450).
Shalev teaches that the electrode in anchored to the tissue with the support structure as discussed above but does not specifically teach applying uncured securement material to bone of the human to hold the electrode against the tissue. The examiner relied on Kroll’s teachings for the limitation of application of an uncured securement material to bone of the human to hold the electrode against the tissue. Further, in response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971). Therefore, the rejection is maintained.
Applicant’s arguments with regards to the rejection of claims 2-4 as recited below are not persuasive.
2. The apparatus of claim 1, wherein: the electrode is fixed to the promontory of a cochlea of the mammal.
3.The apparatus of claim 1, wherein: the electrode is located in an artificial hole in the otic capsule.
4. The apparatus of claim 1, wherein: the electrode is in direct or indirect contact with a round window of a cochlea of the mammal.
As discussed in the office action mailed on 1/14/2026, and reiterated above and in the current office action, the claims are directed to an apparatus that comprises an electrode. The language of where and how the electrode is fixed in the otic capsule is intended use. The claims do not recite any additional structural limitations that preclude the teachings of Shalev in view of Kroll and therefore the rejection is maintained.
For similar reasons, claim 40 is rejected since Shalev in view of Kroll teaches the electrode that is placed against tissue of an inner ear of a human; and applying uncured securement material to bone of the human to hold the electrode against the tissue of the inner ear of the human as claimed and in response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971). Therefore, the rejection is maintained.
Claim 32 recites:
32. An apparatus, comprising:
an electrode, wherein the apparatus includes an arrangement that channels an uncured securement material, applied under pressure into the arrangement, to desired locations, and the apparatus is an implantable apparatus implantable in a human recipient attachable to bone of the human recipient.
As recited, the claim comprises “an electrode” and “an arrangement” as the only structural limitations. Under the broadest reasonable interpretation, how the electrode is implanted and where it is implanted and what the “arrangement” does is intended use since the claim is directed to an apparatus. There are no specific structural limitations being claimed. There are no limitations recited regarding the “arrangement” being claimed. Since Shalev in view of Franke teaches the claimed limitations as recited in the claim, they teach the claimed invention.
Further in response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971). Therefore, the rejection is maintained.
New claims
New claims have been addressed in the office action below.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-4, 6, 11, 13, 14 and 51-54 are rejected under 35 U.S.C. 101 because it is drawn to non-statutory subject matter. Applicant recites part of a human, i.e. “… the electrode is at least one of directly or indirectly fixed to an otic capsule or tissue associated with the otic capsule of a mammal at least in part with cured securement material” (Claim 1, lines 2-4) “…the electrode is fixed to the promontory of a cochlea of the mammal (Claim 2 line 2) “the electrode is located in an artificial hole in the otic capsule”(claim 3) , “the electrode is in direct or indirect contact with a round window of a cochlea of the mammal (claim 4 line 2-3), “ an electrode assembly that extends from the stimulator through a mastoid bone of the mammal to the electrode, the electrode being part of the electrode assembly, wherein the electrode is directly fixed to the otic capsule or tissue associated with the otic capsule.” (claim 52 lines 5-7). (Note: Mammal encompasses a human). Congress has excluded claims directed to or encompassing a human organism from patentability. The Leahy-Smith America Invents Act (AIA ), Public Law 112-29, sec. 33(a), 125 Stat. 284, states: Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism. (Please see MPEP Section 2105(III)).
Thus, these claims include a human within the scope and are non-statutory.
A claim directed to or including within its scope a human is not considered to be patentable subject matter under 35 U.S.C. 101. The grant of a limited, but exclusive property right in a human being is prohibited by the Constitution. In re Wakefield, 422 F.2d 897, 164 USPQ 636 (CCPA 1970). The examiner suggests using the phrase "adapted to be fixed/located/in direct or indirect contact" when referring to the location of the electrode in relation to the body part.
The dependent claims inherit the deficiency.
Claim Rejections - 35 USC § 103
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 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 1-4, 40, 45, 50 and 52 are rejected under 35 U.S.C. 103 as being unpatentable over Shalev (U.S. Patent Application Publication Number: US 2010/0198302 A1, hereinafter “Shalev”- PREVIOUSLY CITED) in view of Kroll et al (U.S. Patent Application Publication Number: US 2004/0039244 A1, hereinafter “Kroll”- APPLICANT CITED).
Regarding claims 1 and 50, Shalev teaches an apparatus (e.g. Abstract), comprising:
an electrode (e.g. 440 Fig.4), wherein the electrode (e.g. [0157]: an electrode lead connected to the IPG and is used to deliver inhibition or stimulation to the cochlear nerve via electrical contact in the middle ear) is at least one of directly or indirectly fixed to an otic capsule or tissue associated with the otic capsule of a mammal and the apparatus is implanted in the human recipient (e.g. [0083]-0089]: electrode placed near the fenestra rotunda, [0157]: The electrode 440 is placed adjacent to the cochlear window 450).
Shalev teaches that the electrode in anchored to the tissue with the support structure as discussed above but does not specifically teach applying uncured securement material to bone of the human and attached directly to bone of the human recipient to hold the electrode against the tissue.
In a similar field of endeavor, Kroll teaches a coupling in an implantable device for the ear to the incus of the ossicular chain by applying a curable adhesive 104 between the implantable transducer tip 100 and the incus tissue and allowing it to cure (e.g. 104 Fig. 3, [0047], claim 10). Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to modify the teachings of Shalev and further secure the electrode of Shalev to the tissue at the intended position by applying cured securement material as taught by Kroll in order to provide the predictable results of ensuring that the electrode stays fixed at the target location. (Note: the claims are directed to an apparatus, therefore the location of where the electrode is implanted or in contact with is intended use).
Regarding claims 2-4, Shalev in view of Kroll teaches the claimed invention as discussed above and Shalev teaches the electrode is in direct or indirect contact with a round window of a cochlea of the mammal (e.g. [0157]: The electrode 440 is placed adjacent to the cochlear window 450) and that the electrode is adapted to be or capable of being fixed to the promontory of a cochlea of the mammal and that the electrode is adapted to be or capable of being located in an artificial hole in the otic capsule (Note: the claims are directed to an apparatus, therefore the location of where the electrode is implanted or in contact with is intended use).
Regarding claim 52, Shalev in view of Kroll teaches the claimed invention as discussed above and Shalev further teaches a stimulator unit; and an electrode assembly, wherein the stimulator unit is in signal communication with the electrode by way of an electrode assembly that extends from the stimulator through a mastoid bone of the mammal to the electrode, the electrode being part of the electrode assembly, wherein the electrode is directly fixed to the otic capsule or tissue associated with the otic capsule (e.g. [0157]: An electrical stimulator or Implantable Pulse Generator (IPG)--that is implanted below the mucosal lining of the nasopharynx (nasal part of the pharynx) 420 is the Middle Ear Stimulation Lead -This is an electrode lead connected to the IPG and is used to deliver inhibition or stimulation to the cochlear nerve via electrical contact in the middle ear.)
Regarding claim 40, Shalev teaches a method (e.g. Abstract), comprising:
placing an electrode (e.g. 440 Fig.5) against tissue of an inner ear of a human (e.g. [0157]: The electrode 440 is placed adjacent to the cochlear window 450, [0083]-0089]: electrode is placed near the round window).
Shalev teaches that the electrode in anchored to the tissue with the support structure as discussed above but does not specifically teach applying uncured securement material to bone of the human to hold the electrode against the tissue of the inner ear of the human. In a similar field of endeavor, Kroll teaches a coupling in an implantable device for the ear to the incus of the ossicular chain by applying a curable adhesive 104 between the implantable transducer tip 100 and the incus tissue and allowing it to cure (e.g. 104 Fig. 3, [0047], claim 10). Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to modify the teachings of Shalev and further secure the electrode of Shalev to the tissue at the intended position by applying cured securement material as taught by Kroll in order to provide the predictable results of ensuring that the electrode stays fixed at the target location.
Regarding claim 45, Shalev in view of Kroll teaches the claimed invention as discussed above and Shalev teaches that the tissue is a round window of a cochlea of the human (e.g. [0157]: The electrode 440 is placed adjacent to the cochlear window 450).
Claim 43 is rejected under 35 U.S.C. 103 as being unpatentable over Shalev (U.S. Patent Application Publication Number: US 2010/0198302 A1, hereinafter “Shalev”) in view of Kroll et al (U.S. Patent Application Publication Number: US 2004/0039244 A1, hereinafter “Kroll”- APPLICANT CITED) and further in view of Nitzert et al (U.S. Patent Application Publication Number: US 2019/0240479 A1, hereinafter “Nitzert”- APPLICANT CITED).
Regarding claim 43, Shalev in view of Kroll teaches the claimed invention as discussed above, but they do not specifically teach that the uncured securement material is bone cement that is electrically conductive when cured.
Nitzert teaches using conductive bone cement to secure an electrode to bone tissue (e.g. [0073] Fig.11)
Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to further modify the securement material for the electrode in the teachings of Shalev in view of Kroll to be conductive bone cement as taught by Nitzert in order to provide the predictable results of improving securement and conductivity of the electrode.
Claim 41 is rejected under 35 U.S.C. 103 as being unpatentable over Shalev (U.S. Patent Application Publication Number: US 2010/0198302 A1, hereinafter “Shalev”- PREVIOUSLY CITED) in view of Kroll et al (U.S. Patent Application Publication Number: US 2004/0039244 A1, hereinafter “Kroll”- APPLICANT CITED) and further in view of Franke et al (U.S. Patent Application Publication Number: US 2019/0357847 A1, hereinafter “Franke”- APPLICANT CITED).
Regarding claim 41, Shalev in view of Kroll teaches the claimed invention as discussed above, but they do not specifically teach further channeling the uncured securement material to the bone using a part of an assembly of which the electrode is a part.
Franke teaches injecting a cured material that comprises bone cement in an uncured form to form a conductive cured electrode that is molded to target tissues (e.g. abstract, [0012], [0172]: carrier material 7 such as bone cement comprising conductive elements 6. Material is injected into the body in a liquid phase and then cures to a solid phase, [0173]). Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to modify the teachings of Shalev in view of Kroll to inject the uncured securement material to the bone using a part of an assembly of which the electrode is a part as taught by Franke in order to provide the predictable results of improving the securing of the electrode by molding it to the target tissue.
Claim 44, and 51, 53-55 are rejected under 35 U.S.C. 103 as being unpatentable over Shalev (U.S. Patent Application Publication Number: US 2010/0198302 A1, hereinafter “Shalev”- PREVIOUSLY CITED) in view of Kroll et al (U.S. Patent Application Publication Number: US 2004/0039244 A1, hereinafter “Kroll”- APPLICANT CITED) and further in view of Carlson (U.S. Patent Application Publication Number: US 2020/0338343 A1, hereinafter “Carlson”- APPLICANT CITED).
Regarding claim 44, Shalev in view of Kroll teaches the claimed invention as discussed above and while Shalev teaches that the that the tissue is a round window of a cochlea of the human (e.g. [0157]: The electrode 440 is placed adjacent to the cochlear window 450), they do not teach that the tissue is bone of an otic capsule of the human.
Carlson teaches that it is well known to implant at electrode in the cochlear bone including the promontory and delivering, via the electrode, electrical pulse stimuli to the cochlear bone (e.g., promontory) of the patient (e.g. [0007], [0012]). Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to further modify the teachings of Shalev in view of Kroll to place the electrode at a bone of the cochlear as taught by Carlson in order to provide the predictable results of delivering electrical stimulation in closer proximity to the cochlea as compared to a surface placement.
Regarding claims 51 and 53-55, Shalev in view of Kroll teaches the claimed invention as discussed above, but do not specifically teach the securement material is bone cement and the bone cement completely surrounds an outer periphery of the electrode from a plan view of the electrode or that the apparatus includes a keying structure keyed into the cured securement material, enhancing fixation of the apparatus to tissue of the human relative to that which would be the case in the absence of the keying structure and that the electrode is interference fitted and/or screwed into a partial hole in the otic capsule and excavating and/or drilling into bone of the human to establish an opening in the bone and placing at least a portion of the electrode into the opening.
Carlson teaches that it is well known to implant an electrode in a cochlear bone and using bone cement to adhere an outer periphery of the electrode (e.g. [0048] Fig.2) and that the apparatus includes a keying structure keyed into the cured securement material, enhancing fixation of the apparatus to tissue of the human relative to that which would be the case in the absence of the keying structure (e.g. Figs 5-8,10) and that the electrode is interference fitted and/or screwed into a partial hole in the otic capsule and excavating and/or drilling into bone of the human to establish an opening in the bone and placing at least a portion of the electrode into the opening (e.g. [0013], [0058], [0059]: electrode screw with adhesive such as bone cement). Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to modify the teachings of Kroll in view of Shavel with the electrode having a keying structure and implanted as taught by Carlson in order to provide the predictable results of a secure placement in the otic tissue.
Claim 32 is rejected under 35 U.S.C. 103 as being unpatentable over Shalev (U.S. Patent Application Publication Number: US 2010/0198302 A1, hereinafter “Shalev”- PREVIOUSLY CITED) in view of Franke et al (U.S. Patent Application Publication Number: US 2019/0357847 A1, hereinafter “Franke”- APPLICANT CITED).
Regarding claim 32, Shalev teaches an apparatus, comprising:
an electrode (e.g. 440 Fig.4, 9, C, E, [0157], [0162]), wherein the electrode (e.g. [0157]: an electrode lead connected to the IPG and is used to deliver inhibition or stimulation to the cochlear nerve via electrical contact in the middle ear) that includes a loop (e.g. 22 Figs 14E, F) at a distal portion thereof configured to engage with bone and the apparatus is an implantable apparatus implantable in a human recipient attachable to bone of the human recipient.
They do not specifically teach that the apparatus includes an arrangement that channels an uncured securement material, applied under pressure into the arrangement, to desired locations, and the apparatus is an implantable apparatus implantable in a human recipient attachable to bone of the human recipient.
Franke teaches an apparatus that includes an arrangement, (e.g. 2,3 Figs. 14A-F) that channels an uncured securement material (i.e. bone cement e.g. abstract), applied under pressure into the arrangement (e.g. 22,23 Figs 14A-F [0158]-[160]), to desired locations (e.g. 5 Figs 14A-F). Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to modify the teachings of Shalev to include an arrangement that channels an uncured securement material applied under pressure into the arrangement to desired locations as taught by Franke in order to provide the predictable results of improving the adhesion of the electrode at the target location. (Note: the claims are directed to an apparatus and do not recite any specific structure for the apparatus other than it comprises an electrode and an arrangement for channeling an uncured material. Further the location of where the electrode is implanted or in contact with is intended use).
Claims 37-39 are rejected under 35 U.S.C. 103 as being unpatentable over Shalev (U.S. Patent Application Publication Number: US 2010/0198302 A1, hereinafter “Shalev”- PREVIOUSLY CITED) in view of Franke et al (U.S. Patent Application Publication Number: US 2019/0357847 A1, hereinafter “Franke”- APPLICANT CITED) and further in view of Carlson (U.S. Patent Application Publication Number: US 2020/0338343 A1, hereinafter “Carlson”- APPLICANT CITED).
Regarding claims 37-39, Shalev in view of Franke teaches the claimed invention as discussed above, but they do not specifically teach that the apparatus includes tynes, hooks and/or loops at a distal portion thereof configured to engage with bone and/or the securement material to enhance retention of the apparatus to the bone (as claimed in claim 37) or that the electrode includes keying structure at a location that interfaces with the bone and/or the securement material (as claimed in claim 38) or that the electrode is one or more of fluted, threaded or splined at a location facing the bone (as claimed in claim 39).
Carlson teaches electrodes that comprise tynes/ barbs (e.g. Fig. 8, [0062], Fig. 10 [0066],[0067]) and an electrode that includes a keying structure (i.e. electrode screw that is screwed/ keyed into the tissue e.g. Fig. 6, [0058],[0059], 1170 Fig.12) and an electrode that is threaded (e.g. Fig. 6 shows that the electrode screw 660 has threads). Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to modify the electrode in the teachings of Shalev in view of Franke to have tynes, hooks and/or loops (as claimed in claim 37) or a keying structure or be threaded at a location that interfaces with the bone (as claimed in claims 38 and 39) in order to provide the predictable results of ensuring that the electrode is properly secured at the target location.
While no prior art rejections have been provided for claims 11,13 and 14, they cannot be indicated as allowable due to the rejection under 35 U.S.C. 101 discussed above. The examiner suggests amending claims 11, 13 and 14 to overcome the rejection under 35 U.S.C. 101 and then they would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
No prior art was found teaching individually, or suggesting in combination, all of the features of the applicants' invention, specifically “ the hollow structure contains at least some of the cured securement material as claimed in claim 11, “the apparatus includes a port for the injection of uncured securement material into the hollow structure: as claimed in claim 13 and “the apparatus includes a shroud configured to at least limit a flow of uncured securement material prior to curing” as claimed in claim 14, in combination with the recited structural limitations of the claimed invention.
Allowable Subject Matter
Claims 34-36 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
No prior art was found teaching individually, or suggesting in combination, all of the features of the applicants' invention, specifically “the electrode is an elongate electrode that extends inside the apparatus that includes the arrangement that channels the uncured securement material to a location outside the arrangement as claimed in claim 35, “a shroud that extends about the channel, which shroud contains the uncured securement material therein” as claimed in claim 34, and “the support structure includes at least one outrigger that supports the electrode away from the arrangement that channels the uncured securement material” as claimed in claim 36, in combination with the recited structural limitations of the claimed invention.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Ren et al (U.S. Patent Number: US 5776179, hereinafter “Ren”) teaches that it is well known to implant an electrode in a cochlear bone using bone cement to adhere an outer periphery of the electrode and that the apparatus includes a keying structure keyed into the cured securement material, enhancing fixation of the apparatus to tissue of the human relative to that which would be the case in the absence of the keying structure (e.g. Figs 5-8,10) and that the electrode is interference fitted and/or screwed into a partial hole in the otic capsule and excavating and/or drilling into bone of the human to establish an opening in the bone and placing at least a portion of the electrode into the opening (e.g. Col. 7 lines 1-12: the electrode can be fixed directly to the bone with a bone cement, the electrode could be secured with a small fastener, such as a screw, an access port could be drilled into the bone providing a passage in close proximate position adjacent the cochlea to provide for close positioning of the electrode thereto, the electrode could be securely packed into the passage with a snug fit, or could be cemented therein).
Applicant's amendment necessitated the new grounds of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MALLIKA DIPAYAN FAIRCHILD whose telephone number is (571)270-7043. The examiner can normally be reached Monday- Friday 8 am-5pm EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, BENJAMIN KLEIN can be reached at 571-270-5213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MALLIKA D FAIRCHILD/Primary Examiner, Art Unit 3792
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