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 Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation is: “an arrangement that channels uncured securement material” in claim 32.
Because this claim limitation is being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it is being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this limitation interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation to avoid it being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation recites sufficient structure to perform the claimed function so as to avoid it being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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 32 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.
Claim 34 recites the limitation "the channel" in line 2. There is insufficient antecedent basis for this limitation in the claim.
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 16 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 human 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 human (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 human (claim 4 line 2-3).
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 and 45 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”) in view of Kroll et al (U.S. Patent Application Publication Number: US 2004/0039244 A1, hereinafter “Kroll”- APPLICANT CITED).
Regarding claim 1, 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 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.
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 human (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 human 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 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).
Claims 6, 16, 42 and 43 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”) 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 6, Shalev in view of Kroll teaches the claimed invention and they teach that the securement material is at least partially interposed between the electrode and the tissue of the otic capsule as discussed above, they do not specifically teach that the cured securement material is electrically conductive.
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.
Regarding claims 16, 42 and 43, Shalev in view of Kroll teaches the claimed invention as discussed above, but they do not specifically teach that the cured securement material is cured bone cement and the cured bone cement is conductive.
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”) 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 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 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.
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”) 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”) 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
Claim 34 would be allowable if rewritten to overcome the rejections under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
Claims 35 and 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
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.
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/MALLIKA D FAIRCHILD/Primary Examiner, Art Unit 3792