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 Objections
Claim 45 is objected to because of the following informalities: “wherein” is repeated twice (lines 1-2).
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 39-41, 45, 47-53 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.
The term “hard” in claim 39 is a relative term which renders the claim indefinite. The term “hard” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is unclear what materials would be deemed suitably “hard” for construction of the device.
The term “resilient” in claims 39, 47, 49, 51-53 is a relative term which renders the claim indefinite. The term “resilient” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is unclear what materials would be deemed suitably “resilient” for construction of the device.
The term “firmly” in claim 45 is a relative term which renders the claim indefinite. The term “firmly” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is unclear how much force would be required to “firmly” hold the electrode array body.
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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 37-38, 42-45, 47, 51, 53, 49 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Walling et al. (US Pre-Grant Publication 2023/0414932), hereinafter ‘Walling’.
Regarding claim 37, Walling teaches an apparatus comprising:
a cochlear implant (cochlear implant 100, Fig. 1A) including an electrode array (electrode array 146, Fig. 5) with an array body that defines an outer surface and a plurality of electrically conductive contacts on the array body (electrodes 1-3, Fig. 5); and
a case (conductive apparatus 622, Fig. 9), in which at least the array body is located, that is configured to maintain the array body in straight state ([0176], cochlear implant is shipped with electrode array in straight orientation).
Regarding claim 38, Walling teaches the device of claim 37, further comprising:
wherein the case includes first and second members (unlabeled) that are movable between an open state (Fig. 19) and a closed state (Fig. 18); and
in the closed state, the first and second members together define a volume (passage 624, Fig. 6) having the same size and shape as the array body ([0077], passage is sized/dimensioned to receive electrode array).
Regarding claim 42, Walling teaches the device of claim 37, further comprising:
wherein the case (conductive apparatus 1822, Fig. 18) includes an enclosure (portion 622, Fig. 18) and a carrier (portion 1821, Fig. 18) that supports the electrode array ([0116-0117]); and
the carrier is movable between an open position where the electrode array body is located outside the enclosure (Fig. 19) and a closed position where the electrode array body is located inside the enclosure (Fig. 18).
Regarding claim 43, Walling teaches the device of claim 42, further comprising:
wherein the electrode array body defines a length; and
the enclosure includes an electrode array contact surface ([0082], inner surface of passage 624) that engages the electrode array body along the length of the electrode array body when the carrier is in the closed position (Fig. 18) ([0117], Fig. 19 depicts when the interior surface is no longer in contact with electrode array).
Regarding claim 44, Walling teaches the device of claim 42, further comprising:
wherein the carrier includes a channel in which the electrode array body is located (interior 1824, Fig. 19).
Regarding claim 45, Walling teaches the device of claim 43, further comprising:
wherein the electrode array body is at least firmly held between the carrier and the electrode array contact surface when the carrier is in the closed position ([0082], electrodes held in contact with passageway 624).
Regarding claim 47, Walling teaches the device of claim 37, further comprising:
wherein the array body has a size and a shape (Fig. 5);
the case (conductive apparatus 2422, Fig. 24) includes a resilient base with a base recess having a size and shape that corresponds to the size and shape of one-half of the array body;
the case includes a resilient cover, that is separable from the resilient base, with a cover recess having a size and shape that corresponds to the size and shape of one-half of the array body ([0140], Fig. 24, two portions of conductive apparatus 2422 are separable from each other); and
the base recess and the cover recess together form a storage volume in which the array body is located ([0140], two portions are placed around electrode array).
Regarding claim 51, Walling teaches the device of claim 47, further comprising:
wherein the resilient base is formed from hydrophobic material; and
the resilient cover is formed from hydrophobic material ([0079], conductive apparatus is made of rubber, silicone, etc.).
Regarding claim 53, Walling teaches the device of claim 47, further comprising:
wherein the resilient base and the resilient cover together form a seal when the case is in a closed state (Fig. 24, two portions are attached).
Regarding claim 49, Walling teaches the device of claim 47, further comprising:
a tray (package 410, Fig. 11) including a plurality of compartments;
wherein the resilient base and the resilient cover are located within one of the compartments (Fig. 11, conductive apparatus 622).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 39, 41, 50 are rejected under 35 U.S.C. 103 as being unpatentable over Walling et al. (US Pre-Grant Publication 2023/0414932).
Regarding claim 39, Walling teaches the device of claim 37, further comprising:
wherein the array body has a size and a shape (Fig. 5);
the case (conductive apparatus 2422, Fig. 24) includes a base and a cover that are movable between an open state and a closed state ([0140], Fig. 24, two portions of conductive apparatus 2422 are separable from each other);
the base includes a hard exterior portion and a resilient interior portion with a base recess having a size and shape that corresponds to the size and shape of one- half of the array body;
the cover includes a hard exterior portion and a resilient interior portion with a cover recess having a size and shape that corresponds to the size and shape of the other half of the array body; and
the base recess and the cover recess together form a storage volume in which the array body is located ([0140], two portions are placed around electrode array).
Walling does not teach that the base and cover are pivotably connected to one another.
It would have been an obvious matter of design choice to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Walling to pivotably connect the two portions, since applicant has not disclosed that a pivotable connection solves any stated problem or is for any particular purpose and it appears that the invention would perform equally as well with a pivotable connection.
Regarding claim 41, Walling teaches the device of claim 39, further comprising a base and cover maintained in a closed state (Fig. 24, two portions are attached).
Walling does not teach that the base and cover are closed via a latch (due to being pivotably connected).
It would have been an obvious matter of design choice to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Walling to include a latch to secure the pivotably connected portions, since applicant has not disclosed that a pivotable connection solves any stated problem or is for any particular purpose and it appears that the invention would perform equally as well with a pivotable connection.
Regarding claim 50, Walling teaches the device of claim 47, further comprising:
wherein the case is press fit into one of the compartments (Fig. 11) ([0091], conductive apparatus 622 is located in package 410).
Walling does not teach the tray has outer/inner components and a tray top.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to separate the tray into an outer tray, inner tray, and tray top, since it has been held that constructing a formerly integral structure in various elements involves only routine skill in the art. Nerwin v. Erlichman, 168 USPQ 177, 179.
Claims 40, 46, 48 are rejected under 35 U.S.C. 103 as being unpatentable over Walling et al. (US Pre-Grant Publication 2023/0414932) in view of Hoffman et al. (US Pre-Grant Publication 2024/0325732), hereinafter ‘Hoffman’.
Regarding claims 40, 48, Walling teaches the device of claims 39 and 47, respectively, further comprising:
wherein the base recess has a size and shape that corresponds to the size and shape of one-half of the array body;
the cover recess has a size and shape that corresponds to the size and shape of the other half of the array body; and
the base recess and the cover recess together form a storage volume in which the array body is located ([0140], Fig. 24, two portions of conductive apparatus 2422 are separable from each other).
Walling does not teach that the electrode array includes a wing, or that the base/cover have recesses to fit the wing.
Hoffman teaches a method of forming a cochlear implant electrode array (abstract), further comprising:
wherein the electrode array includes a wing, with a size and a shape, at one end of the array body (Fig. 2, wing 128).
It would have been prima facie obvious before the effective filing date of the claimed invention to have modified Walling to incorporate the teachings of Hoffman to include a wing. Doing so would provide a handle for the surgeon during implantation surgery and tension relief for lead wires, as recognized by Hoffman [0110].
Neither Hoffman or Walling teach that an electrode array case can accommodate a wing.
Regarding claim 46, Walling teaches the device of claim 42, but does not teach that the electrode array includes a wing, or that the wing is located outside the enclosure when the carrier is closed.
Hoffman teaches a method of forming a cochlear implant electrode array (abstract), further comprising:
wherein the electrode array includes a wing at one end of the array body (Fig. 2, wing 128).
It would have been prima facie obvious before the effective filing date of the claimed invention to have modified Walling to incorporate the teachings of Hoffman to include a wing. Doing so would provide a handle for the surgeon during implantation surgery and tension relief for lead wires, as recognized by Hoffman [0110].
Neither Hoffman or Walling teach that an electrode array case can accommodate a wing and that the wing is located outside the enclosure when the carrier is closed.
Allowable Subject Matter
Claims 54-56 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.
Walling et al. (US Pre-Grant Publication 2023/0414932) is the closest prior art, teaching an electrode array (146) with a case (conductive apparatus 622, Fig. 9), but does not teach a cobalt dichloride-based moisture detector located on the case. Therefore, the limitation is novel and non-obvious.
Conclusion
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/E.L.O./
Examiner, Art Unit 3792
/SHIRLEY X JIAN/Primary Examiner, Art Unit 3792 May 29, 2026
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