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 .
Information Disclosure Statement
The information disclosure statement (IDS), submitted on 08/07/2023, has been considered by the examiner.
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 “array guide” and “functional component” 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 specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required: The claimed subject matter of an “array guide,” “functional component,” and “active functional components,” are not found within the originally filed specification.
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required: The originally filed specification fails to disclose “wherein the at least one electrode is operable to establish a capacitive coupling with at least one of an anatomical structure of the recipient of the cochlear electrode array inserted by the tool or the cochlear electrode array inserted by the tool” (as recited in claim 21).
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(s) is/are: “substance delivery mechanism” in claim 2.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are 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/these limitation(s) 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(s) to avoid it/them 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(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them 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.
Claims 1-33 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 1] The claim recites the limitation of a “functional component.” The examiner is unable to determine the metes and bounds of the claim, since the instant specification fails to recite/describe what structure or structures are intended to be covered by such a limitation. The term is not an understood term of the art; nor would a person having ordinary skill in the art have an understanding of the scope of the phrase. For purposes of examination, it is interpreted that the limitation can be met by any structure that is a portion of the claimed tool.
[Claims 8 and 15] The claims recite the limitation of “the functional component.” There is a lack of antecedent basis for this limitation in the claims. Furthermore, the examiner is unable to determine the metes and bounds of the claims, since it is unclear if this limitation is the same or different limitation from the previously recited “at least one functional component.” For purposes of examination, it is interpreted that the limitation refers to the previously recited “at least one functional component.”
[Claims 8 and 15] The claims recite the limitation of “the tool.” There is a lack of antecedent basis for this limitation in the claims. Furthermore, the examiner is unable to determine the metes and bounds of the claims, since it is unclear if this limitation is the same or different limitation from the previously recited “cochlear electrode array insertion tool.” For purposes of examination, it is interpreted that the limitation refers to the previously recited “cochlear electrode array insertion tool.”
[Claim 8] The claim recites the limitation of “the functional component is held stationary relative to the array guide while a cochlear electrode array is being inserted into a cochlea using the tool.” The examiner is unable to determine the metes and bounds of the claim, since it appears a method step is being recited within the bounds of an apparatus claim. For purposes of examination, the limitation is interpreted as “the functional component is configured to be held stationary relative to the array guide while a cochlear electrode array is being inserted into a cochlea using the tool.”
[Claim 9] The claim recites the limitations of “the tool” and “the surgical tool.” There is a lack of antecedent basis for these limitations in the claims. Furthermore, the examiner is unable to determine the metes and bounds of the claim, since it is unclear if these limitations are the same or different limitation from the previously recited “cochlear electrode array insertion tool.” For purposes of examination, it is interpreted that the limitations refer to the previously recited “cochlear electrode array insertion tool.”
[Claim 10] The claim recites the limitation of “the intra-cochlear portion.” There is a lack of antecedent basis for this limitation in the claims. Furthermore, the examiner is unable to determine the metes and bounds of the claim, since it is unclear if the claim was intended to depend from claim 8 or claim 9. For purposes of examination and to provide proper antecedent basis, it is interpreted that the claim depends directly from claim 9.
[Claim 11] The claim recites the limitations of “the extra-cochlear portion” and “the intra-cochlear portion.” There is a lack of antecedent basis for these limitations in the claims. Furthermore, the examiner is unable to determine the metes and bounds of the claim, since it is unclear if the claim was intended to depend from claim 8 or claim 9. For purposes of examination and to provide proper antecedent basis, it is interpreted that the claim depends directly from claim 9.
[Claims 10 and 11] The claims recite the limitation of “a cochlea.” The examiner is unable to determine the metes and bounds of the claims, since it is unclear if these limitations refer to the same or different limitation from the previously recited “cochlea” of claim 8. For purposes of examination, it is interpreted that the limitations refer to the previously recited “cochlea.”
[Claim 12] The claim recites the limitation of “the tool.” There is a lack of antecedent basis for this limitation in the claims. Furthermore, the examiner is unable to determine the metes and bounds of the claim, since it is unclear if this limitation is the same or different limitation from the previously recited “cochlear electrode array insertion tool.” For purposes of examination, it is interpreted that the limitation refers to the previously recited “cochlear electrode array insertion tool.”
[Claims 12 and 13] The claims positively recite the limitations of “a cochlear electrode array is located in the tool” and “a stimulator of a cochlear implant is attached via a lead assembly to the cochlear array, the stimulator and the electrode array being parts of an implantable portion of a cochlear implant.” The examiner is unable to determine the metes and bounds of the claims, since these limitations are positively recited as part of the “insertion tool.” As these would appear to be separate structures from the claimed apparatus, it is unclear how they can be positively recited structures. For purposes of examination, it is interpreted that the limitations are only functionally recited.
[Claim 14] The claim recites the limitation of “the array guide has an elongate hollow portion through which an electrode array moves during insertion into a cochlea.” The examiner is unable to determine the metes and bounds of the claim, since it appears a method step is being recited within the bounds of an apparatus claim. For purposes of examination, the limitation is interpreted as “the array guide has an elongate hollow portion through which an electrode array is configured to move during insertion into a cochlea.”
[Claims 14 and 23] The claims recite the limitation of “which elongate hollow portion is empty.” The examiner is unable to determine the metes and bounds of the claims, since the limitation does not make sense grammatically. For purposes of examination, the limitation is interpreted as “wherein the elongate hollow portion is empty.”
[Claim 16] The claim recites the limitations of “the insertion tool” and “the tool.” There is a lack of antecedent basis for these limitations in the claims. Furthermore, the examiner is unable to determine the metes and bounds of the claim, since it is unclear if these limitations are the same or different limitation from the previously recited “cochlear electrode array insertion tool.” For purposes of examination, it is interpreted that the limitations refer to the previously recited “cochlear electrode array insertion tool.”
[Claim 16] The claim recites the limitation of “the electrode.” There is a lack of antecedent basis for this limitation in the claims. For purposes of examination, the limitation is interpreted as “an electrode.”
[Claim 16] The claim recites the limitation of “the electrode array guide.” There is a lack of antecedent basis for this limitation in the claims. Furthermore, the examiner is unable to determine the metes and bounds of the claim, since it is unclear if this limitation is the same or different limitation from the previously recited “array guide.” For purposes of examination, it is interpreted that the limitation refers to the previously recited “array guide.”
[Claim 17] The claim recites the limitation of “the electrode array guide.” There is a lack of antecedent basis for this limitation in the claims. Furthermore, the examiner is unable to determine the metes and bounds of the claim, since it is unclear if this limitation is the same or different limitation from the previously recited “electrode array insertion guide.” For purposes of examination, it is interpreted that the limitation refers to the previously recited “electrode array insertion guide.”
[Claim 20] The claim recites the limitation of “the tool.” There is a lack of antecedent basis for this limitation in the claims. Furthermore, the examiner is unable to determine the metes and bounds of the claim, since it is unclear if this limitation is the same or different limitation from the previously recited “electrode array insertion tool.” For purposes of examination, it is interpreted that the limitation refers to the previously recited “electrode array insertion tool.”
[Claim 21] The claim recites the limitation of “the recipient.” There is a lack of antecedent basis for this limitation in the claims. For purposes of examination, the limitation is interpreted as “a recipient.”
[Claim 21] The claim recites the limitation of “the tool.” There is a lack of antecedent basis for this limitation in the claims. Furthermore, the examiner is unable to determine the metes and bounds of the claim, since it is unclear if this limitation is the same or different limitation from the previously recited “electrode array insertion tool.” For purposes of examination, it is interpreted that the limitation refers to the previously recited “electrode array insertion tool.”
[Claims 23 and 24] The claims recite the limitations of “an electrode array.” The examiner is unable to determine the metes and bounds of the claims, since it is unclear if these limitations are the same or different from the previously recited “cochlear electrode array” of claim 17. For purposes of examination, the limitations are interpreted as “the cochlear electrode array.”
[Claim 25] The claims recite the limitation of “one or more active functional components.” The examiner is unable to determine the metes and bounds of the claim, since the instant specification fails to recite/describe what structure or structures are intended to be covered by such a limitation. The term is not an understood term of the art; nor would a person having ordinary skill in the art have an understanding of the scope of the phrase. Furthermore, it is unclear how the term “active” is further intended to alter the meaning of the limitation, as such a term could be interpreted as relative. For purposes of examination, it is interpreted that the limitation can be met by any structure that is a portion of the claimed tool.
[Claim 26] The claim recites the limitation of “the one or more functional components.” There is a lack of antecedent basis for this limitation in the claims. Furthermore, the examiner is unable to determine the metes and bounds of the claim, since it is unclear if this limitation is the same or different limitation from the previously recited “one or more active functional components.” For purposes of examination, it is interpreted that the limitation refers to the previously recited “one or more active functional components.”
[Claim 30] The claim recites the limitation of “wherein the at least one electrode.” There is a lack of antecedent basis for this limitation in the claims. Furthermore, the examiner is unable to determine the metes and bounds of the claim, since it is unclear if the claim was intended to depend from claim 28 or claim 29. For purposes of examination and to provide proper antecedent basis, it is interpreted that the claim depends directly from claim 29.
[Claims 2-16, 18-24, and 26-33] The claims are rejected based upon their dependency from independent claims 1, 17, and 25.
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 1-16 and 25-33 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Debruyne et al. (PGPub 2006/0287689).
[Claims 1-3] Debruyne teaches a cochlear electrode array insertion tool (figure 19, item 230), comprising:
an array guide (figure 19, item 240); and
at least one functional component (figure 19, items 247/280) disposed in or on the array guide (figure 19, item 240), wherein at least a portion of the functional component (figure 19, items 247/280) is fixed relative to the array guide (figure 19, item 240);
wherein the at least one functional component (figure 19, items 247/280) comprises a substance delivery lumen (figure 19, item 247) and syringe port (figure 19, item 280) (figure 19, paragraphs [0222], [0223], [0229]).
[Claim 1; alternatively] Debruyne teaches a cochlear electrode array insertion tool (figure 19, item 230), comprising:
an array guide (figure 19, item 231); and
at least one functional component (figure 19, items 232; understood to be the same as “electrodes” 132; paragraph [0202]) disposed in or on the array guide (figure 19, item 231), wherein at least a portion of the functional component (figure 19, items 232) is fixed relative to the array guide (figure 19, item 231) (figure 19).
[Claims 4-7] Debruyne teaches the limitations of claim 1, upon which claims 4-7 depend. Debruyne also teaches the at least one functional component (figure 19, items 232) comprises a plurality of electrodes (figure 19) formed into two or more functional groups of electrodes (the examiner notes the claim limitation of a “functional group,” lacking any explicit definition within applicants’ specification or limitations in the claims, is arbitrary; as such, the electrodes taught by the prior art could easily be viewed as multiple “functional groups”), forming a portion of a circuit (figure 19; paragraphs [0009], [0129], [0130], [0137]).
[Claims 8, 14, and 16] Debruyne teaches the limitations of claims 1 and 2, upon which claims 8, 14, and 16, depend. Debruyne further discloses the insertion tool (figure 19, item 230) is configured to hold the electrode (figure 19, items 232) stationary (the examiner notes electrodes 232 are stationary and fixed to item 231) relative to the electrode array guide (figure 19, item 231), while a cochlear electrode array (see 112b interpretation above) (the examiner notes the additional “electrode array” is only functionally recited as being used with the claimed tool) is being inserted through an empty elongate hollow portion (figure 19a/b shows a lumen for lead 21 to move through guide 231; said lumen is therefore capable of allowing an “electrode array” move within) of the array guide (figure 19, item 231) into a cochlea (figure 1, item 12) using the tool (figure 19, item 230).
[Claims 9-11] Debruyne teaches the limitations of claim 1, upon which claims 9-11 depend (see 112b interpretation above). In addition, Debruyne discloses the tool (figure 19, item 230) comprises an intra-cochlear portion (figure 19, distal end of item 231; paragraphs [0217], [0225]) and an extra-cochlear portion (figure 19, item 240; paragraph [0218]), wherein the extra-cochlear portion (figure 19, item 240) facilitates manipulation of the surgical tool (figure 19, item 230) during surgery (figure 1; paragraph [0009], [0218]);
wherein the intra-cochlear portion (figure 19, distal end of item 231) is configured for insertion through a round window (“cochleostomy”) of a cochlea (figure 1, item 12) (figure 1; paragraphs [0009], [0064], [0167], [0225]); and
wherein the array guide (figure 19, item 231) includes a tube (figure 19a/b shows a lumen for lead 21 to move through guide 231; said lumen is therefore capable of allowing an “electrode array” move within) that extends from the extra-cochlear portion (figure 19, item 240) to the intra-cochlear portion (figure 19, distal end of item 231), and wherein the tube (figure 19a/b shows a lumen for lead 21 to move through guide 231; said lumen is therefore capable of allowing an “electrode array” move within) is configured to permit a cochlear electrode array (the examiner notes the additional “electrode array” is only functionally recited as being used with the claimed tool) to be advanced through the array guide (figure 19, item 231) into a cochlea (figure 1, item 12).
[Claims 12 and 13] Debruyne teaches the limitations of claim 1, upon which claims 12 and 13 depend. Debruyne further discloses a cochlear electrode array (figure 1, item 20) is located in the tool (figure 19, item 230) (see 112b interpretation above) (the examiner notes the additional “electrode array” is being interpreted as only functionally recited for use with the claimed tool) (figure 1; paragraph [0167], [0170]); and a stimulator (figure 1, item 22) of a cochlear implant (figure 1, items 20/21/22/23/24/29) is attached via a lead assembly (figure 1, item 21) to the cochlear electrode array (figure 1, item 20), the stimulator (figure 1, item 22) and the electrode array (figure 1, item 20) being parts of an implantable portion (figure 1, items 20/21/22/23) of a cochlear implant (figure 1, items 20/21/22/23/24/29) (the examiner notes the “stimulator,” “cochlear implant,” and “lead assembly” are being interpreted as only functionally recited for use with the claimed tool) (see 112b interpretation above).
[Claim 15] Debruyne teaches the limitations of claim 1, upon which claim 15 depends. Debruyne also teaches the functional component (figure 19, items 232) is separate from a stimulator (figure 1, item 22) of an implantable portion (figure 1, items 20/21/22/23) of a cochlear implant (figure 1, items 20/21/22/23/24/29) that is in wired communication (figure 1, via item 21) with an electrode array (figure 1, item 20) of the cochlear implant (figure 1, items 20/21/22/23/24/29) insertable into a cochlea (figure 1, item 12) using the tool (figure 19, item 230) (the examiner notes the “stimulator,” “cochlear implant,” and “electrode array” are only functionally recited for use with the claimed tool).
[Claim 25] Debruyne teaches a surgical tool (figure 19, item 230) comprising:
an intra-cochlear portion (figure 19, distal end of item 231; paragraphs [0217], [0225]) configured to be inserted into a cochlea (figure 1, item 12) of a recipient (figure 1; paragraphs [0009], [0064], [0167], [0225]), wherein the intra-cochlear portion (figure 19, distal end of item 231) comprises an insertion lumen (figure 19a/b shows a lumen for lead 21 to move through guide 231; said lumen is therefore capable of allowing an “electrode array” move within) configured to receive and to guide a stimulating assembly (figure 1, item 20) of an implantable medical device (figure 1, items 20/21/22/23/24/29) into position within the cochlea (figure 1, item 12) (the examiner notes the “stimulating assembly” and “implantable medical device” are only functionally recited),
wherein the intra-cochlear portion (figure 19, distal end of item 231) of the surgical tool (figure 19, item 230) comprises one or more active functional components (figure 19, items 232; understood to be the same as “electrodes” 132; paragraph [0202]) (see 112b interpretation above).
[Claims 26 and 27] Debruyne teaches the limitations of claim 25, upon which claims 26 and 26 depend. In addition, Debruyne teaches the intra-cochlear portion (figure 19, distal end of item 231) comprises a sheath (figure 19, item 231), and wherein the one or more functional components (figure 19, items 232) form part of the sheath (figure 19, item 231); wherein the one or more active functional components (figure 19, items 232) comprise a portion of a circuit formed on an outer surface of the sheath (figure 19, item 231) (figure 19; paragraphs [0009], [0129], [0130], [0137]).
[Claims 28-30] Debruyne teaches the limitations of claim 25, upon which claims 28-30 depend (see 112b interpretation above). Debruyne also teaches the one or more active functional components (figure 19, items 232) comprises a plurality of electrodes (figure 19) that are formed into two or more functional groups of electrodes (the examiner notes the claim limitation of a “functional group,” lacking any explicit definition within applicants’ specification or limitations in the claims, is arbitrary; as such, the electrodes taught by the prior art could easily be viewed as multiple “functional groups”), configured to generate an electric field (paragraph [0009]).
[Claims 31 and 32] Debruyne teaches the limitations of claim 25, upon which claims 31 and 32 depend. Debruyne further discloses the surgical tool (figure 19, item 230) has an extra-cochlear portion (figure 19, item 240; paragraph [0218]) that facilitates manipulation of the surgical tool (figure 19, item 230) during surgery (figure 1; paragraph [0009], [0218]) and wherein the intra-cochlear portion (figure 19, distal end of item 231) is configured for insertion through a round window (“cochleostomy”) of a cochlea (figure 1, item 12) (figure 1; paragraphs [0009], [0064], [0167], [0225]).
[Claim 33] Debruyne teaches the limitations of claim 25, upon which claim 33 depends. In addition, Debruyne teaches the surgical tool (figure 19, item 230) has at least one electrical connector (figure 1, item 21) configured to electrically connect to the one or more active functional components (figure 19, items 232) (figure 1; paragraph [0167], [0170]).
Claims 1-33 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gibson (PGPub 2009/0076581).
[Claims 1-3] Gibson teaches a cochlear electrode array insertion tool (figures 1 and 2a, items 142/200; paragraph [0029]), comprising:
an array guide (“carrier member”) (figures 2a and 5a, items 202/220); and
at least one functional component (figure 5a, items 224/240/404) disposed in or on the array guide (figures 2a and 5a, items 202/220), wherein at least a portion of the functional component (figure 5a, items 224/240/404) is fixed relative to the array guide (figures 2a and 5a, items 202/220) and comprises a substance delivery lumen (figure 5a, items 224/240) and syringe port (figure 5a, item 404).
[Claim 1; alternatively] Gibson teaches a cochlear electrode array insertion tool (figures 1 and 2a, items 142/200; paragraph [0029]), comprising:
an array guide (“carrier member”) (figures 2a and 5a, items 202/220); and
at least one functional component (figure 2a, item 250) disposed in or on (as best seen in figure 2b) the array guide (figures 2a and 5a, items 202/220), wherein at least a portion of the functional component is fixed relative to the array guide (figures 2a and 5a, items 202/220).
[Claims 4-7] Gibson teaches the limitations of claim 1, upon which claims 4-7 depend. Gibson also teaches the at least one functional component (figure 2a, item 250) comprises a plurality of electrodes (figure 2a) which are formed into two or more functional groups of electrodes (the examiner notes the claim limitation of a “functional group,” lacking any explicit definition within applicants’ specification or limitations in the claims, is arbitrary; as such, the electrodes taught by the prior art could easily be viewed as multiple “functional groups”), forming a portion of a circuit (paragraph [0006]).
[Claims 8, 14, and 16] Gibson teaches the limitations of claims 1 and 2, upon which claims 8, 14, and 16, depend. Gibson further discloses the insertion tool (figures 1 and 2a, items 142/200) is configured to hold the electrode (figure 2a, item 250) stationary (the examiner notes electrodes 250 are stationary and fixed to item 202/220) relative to the electrode array guide (figures 2a and 5a, items 202/220), while a cochlear electrode array (see 112b interpretation above) (the examiner notes the additional “electrode array” is only functionally recited as being used with the claimed tool) is being inserted through an empty elongate hollow portion (figure 2b, item 224) of the array guide (figures 2a and 5a, items 202/220) into a cochlea (figure 5a, item 115) using the tool (figures 1 and 2a, items 142/200).
[Claims 9-11] Gibson teaches the limitations of claim 1, upon which claims 9-11 depend (see 112b interpretation above). In addition, Gibson discloses the tool (figures 1 and 2a, items 142/200) comprises an intra-cochlear portion (figure 5a; portion distal to cochleostomy 152) and an extra-cochlear portion (figure 5a; portion proximal to cochleostomy 152), wherein the extra-cochlear portion (figure 5a; portion proximal to cochleostomy 152) facilitates manipulation of the surgical tool (figures 1 and 2a, items 142/200) during surgery (paragraph [0042]);
wherein the intra-cochlear portion (figure 5a; portion distal to cochleostomy 152) is configured for insertion through a round window (“cochleostomy”; figure 5a, item 152) of a cochlea (figure 5a, item 115) (figure 5a; paragraph [0042]); and
wherein the array guide (figures 2a and 5a, items 202/220) includes a tube (figure 5a, item 224) that extends from (“in one embodiment, lumen 224 extends along electrode assembly 200 from outside cochlea 115 to inside the cochlea when the device is implanted in the cochlea. As such, electrode carrier member 202 may be configured so that opening 404 for lumen 224 is located outside cochlea 115 when the carrier member is implanted in cochlea 115.”) the extra-cochlear portion (figure 5a; portion proximal to cochleostomy 152) to the intra-cochlear portion (figure 5a; portion distal to cochleostomy 152) (paragraphs [0042], [0043]), and wherein the tube (figure 5a, item 224) is configured to permit a cochlear electrode array (the examiner notes the additional “electrode array” is only functionally recited as being used with the claimed tool) to be advanced through the array guide (figures 2a and 5a, items 202/220) into a cochlea (figure 5a, item 115).
[Claims 12 and 13] Gibson teaches the limitations of claim 1, upon which claims 12 and 13 depend. Gibson further discloses a cochlear electrode array (figure 1, item 144) is located in the tool (figures 1 and 2a, items 142/200) (see 112b interpretation above) (the examiner notes the additional “electrode array” is being interpreted as only functionally recited for use with the claimed tool); and a stimulator (figure 1, item 134; paragraph [0026]) of a cochlear implant (figure 1, item 120) is attached via a lead assembly (figure 1, item 140) to the cochlear electrode array (figure 1, item 144), the stimulator (figure 1, item 134) and the electrode array (figure 1, item 144) being parts of an implantable portion (figure 1, item 124) of a cochlear implant (figure 1, item 120) (figure 1; paragraphs [0026], [0027]) (the examiner notes the “stimulator,” “cochlear implant,” and “lead assembly” are being interpreted as only functionally recited for use with the claimed tool) (see 112b interpretation above).
[Claim 15] Gibson teaches the limitations of claim 1, upon which claim 15 depends. Gibson also teaches the functional component (figure 2a, item 250) is separate from a stimulator (figure 1, item 134) of an implantable portion (figure 1, item 124) of a cochlear implant (figure 1, item 120) that is in wired communication (figure 1; via item 140) with an electrode array (figure 1, item 144) of the cochlear implant (figure 1, item 120) insertable into a cochlea (figure 5a, item 115) using the tool (figures 1 and 2a, items 142/200) (the examiner notes the “stimulator,” “cochlear implant,” and “electrode array” are only functionally recited for use with the claimed tool).
[Claims 17 and 22] Gibson teaches an electrode array insertion tool (figures 1 and 2a, items 142/200; paragraph [0029]), comprising:
an electrode array insertion guide (“carrier member”) (figures 2a and 5a, items 202/220); and
at least one electrode (figure 2a, item 250), wherein the electrode array insertion tool (figures 1 and 2a, items 142/200) is configured to hold the at least one electrode (figure 2a, item 250) fixed and stationary (figure 2b) relative to the electrode array guide (figures 2a and 5a, items 202/220) while a cochlear electrode array (the examiner notes the “electrode array” is only functionally recited as being used with the claimed tool) is being moved through (functionally capable via lumen 224) the electrode array insertion guide (figures 2a and 5a, items 202/220).
[Claims 18 and 19] Gibson teaches the limitations of claim 17, upon which claims 18 and 19 depend. In addition, Gibson discloses the at least one electrode (figure 2a, item 250) comprises a plurality of electrodes (figures 2a/5a) mounted on an intra-cochlear portion (figure 5a; portion distal to cochleostomy 152) of the insertion tool (figures 1 and 2a, items 142/200).
[Claim 20] Gibson teaches the limitations of claim 17, upon which claim 20 depends. Gibson further discloses the at least one electrode (figure 2a, item 250) is mounted on the tool (figures 1 and 2a, items 142/200) such that the at least one electrode (figure 2a, item 250) is adjacent a lumen (figure 2b, item 224) of the electrode array insertion guide (figures 2a and 5a, items 202/220).
[Claim 21] Gibson teaches the limitations of claim 17, upon which claim 21 depends. Gibson also teaches the at least one electrode (figure 2a, item 250) is operable to establish a capacitive coupling (paragraphs [0026], [0031]-[0033]) with at least one of an anatomical structure (figure 5a) of the recipient of the cochlear electrode array (figure 1, item 144) inserted by the tool (figures 1 and 2a, items 142/200) or the cochlear electrode array (figure 1, item 144) inserted by the tool (figures 1 and 2a, items 142/200) (paragraphs [0026], [0031]-[0033]).
[Claim 23] Gibson teaches the limitations of claim 17, upon which claim 23 depends. In addition, Gibson teaches the electrode array insertion guide (figures 2a and 5a, items 202/220) has an empty elongate hollow portion (figure 2b, item 224) through which an electrode array (the examiner notes the “electrode array” is only functionally recited as being used with the claimed tool) moves during insertion into a cochlea (figure 5a, item 115).
[Claim 24] Gibson teaches the limitations of claim 17, upon which claim 24 depends. Gibson also teaches the at least one electrode (figure 2a, item 250) is separate from electrodes of an electrode array (the examiner notes the “electrodes of an electrode array” is only functionally recited as being used with the claimed tool) insertable into a cochlea (figure 5a, item 115) using the electrode array insertion tool (figures 1 and 2a, items 142/200).
[Claim 25] Gibson teaches a surgical tool (figures 1 and 2a, items 142/200; paragraph [0029]) comprising:
an intra-cochlear portion (figure 5a; portion distal to cochleostomy 152) configured to be inserted into a cochlea (figure 5a, item 115) of a recipient (figure 5a), wherein the intra-cochlear portion (figure 5a; portion distal to cochleostomy 152) comprises an insertion lumen (figure 5a, item 224) configured to receive and to guide a stimulating assembly of an implantable medical device (the examiner notes the “stimulating assembly of an implantable medical device” is only functionally recited as being used with the claimed tool) into position within the cochlea (figure 5a, item 115),
wherein the intra-cochlear portion (figure 5a; portion distal to cochleostomy 152) of the surgical tool (figures 1 and 2a, items 142/200) comprises one or more active functional components (figure 2a, item 250) (see 112b interpretation above).
[Claims 26 and 27] Gibson teaches the limitations of claim 25, upon which claims 26 and 26 depend. In addition, Gibson teaches the intra-cochlear portion (figure 5a; portion distal to cochleostomy 152) comprises a sheath (figures 2a and 5a, items 202/220), and wherein the one or more functional components (figure 2a, item 250) form part of the sheath (figures 2a and 5a, items 202/220) (figures 2a/2b); wherein the one or more active functional components (figure 2a, item 250) comprise a portion of a circuit (paragraph [0006]) formed on an outer surface (figures 2a/2b) of the sheath (figures 2a and 5a, items 202/220).
[Claims 28-30] Gibson teaches the limitations of claim 25, upon which claims 28-30 depend (see 112b interpretation above). Gibson also teaches the one or more active functional components (figure 2a, item 250) comprises a plurality of electrodes (figure 2a) that are formed into two or more functional groups of electrodes (the examiner notes the claim limitation of a “functional group,” lacking any explicit definition within applicants’ specification or limitations in the claims, is arbitrary; as such, the electrodes taught by the prior art could easily be viewed as multiple “functional groups”), configured to generate an electric field (paragraph [0032]).
[Claims 31 and 32] Gibson teaches the limitations of claim 25, upon which claims 31 and 32 depend. Gibson further discloses the surgical tool (figures 1 and 2a, items 142/200) has an extra-cochlear portion (figure 5a; portion proximal to cochleostomy 152) that facilitates manipulation of the surgical tool (figures 1 and 2a, items 142/200) during surgery (paragraph [0042]) and wherein the intra-cochlear portion (figure 5a; portion distal to cochleostomy 152) is configured for insertion through a round window (“cochleostomy”; figure 5a, item 152) of the cochlea (figure 5a, item 115) (figure 5a; paragraph [0042]).
[Claim 33] Gibson teaches the limitations of claim 25, upon which claim 33 depends. In addition, Gibson teaches the surgical tool (figures 1 and 2a, items 142/200) has at least one electrical connector (figure 1, via item 140) configured to electrically connect to the one or more active functional components (figure 2a, item 250) (figure 1; paragraph [0026]).
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, 8, 12-15, 17, 18, 20-22, and 24, are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 6, 11, 12, 15-19, 22, 26, 27, and 29, of U.S. Patent No. 10,842,531. Although the claims at issue are not identical, they are not patentably distinct from each other because all of the elements of the recited instant application claims are found in the recited patent claims. For example, all of the elements of claim 1 of the instant application can be found in claim 1 of the patent. The difference between claim 1 of the instant application and claim 1 of the patent lies in the fact that the patent claim includes more elements and is thus more specific. Thus, the invention of claim 1 of the patent is in effect a “species” of the "generic” invention of claim 1 of the instant application. It has been held that the generic invention is anticipated by the species. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993). Since claim 1 of the instant application is anticipated by claim 1 of the patent, it is not patentably distinct from claim 1 of the patent.
Claims 25-33 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5, 8, 9, and 11-14, of U.S. Patent No. 11,116,963. Although the claims at issue are not identical, they are not patentably distinct from each other because all of the elements of the recited instant application claims are found in the recited patent claims. For example, all of the elements of claim 25 of the instant application can be found in claim 1 of the patent. The difference between claim 25 of the instant application and claim 1 of the patent lies in the fact that the patent claim includes more elements and is thus more specific. Thus, the invention of claim 1 of the patent is in effect a “species” of the "generic” invention of claim 25 of the instant application. It has been held that the generic invention is anticipated by the species. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993). Since claim 25 of the instant application is anticipated by claim 1 of the patent, it is not patentably distinct from claim 1 of the patent.
Conclusion
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/JASON E FLICK/Primary Examiner, Art Unit 3783 02/06/2026