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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 2/6/2026 has been entered.
Election/Restrictions
Newly submitted claims 11-16 are directed to an invention that is independent or distinct from the invention originally claimed for the following reasons: The claims do not require a container comprising a sealed region, the device/implant contained within the sealed region prior to implantation, the assembly having a portion with a shape while the device/implant is within the sealed region. Removing these limitations broadens the scope of the claims and creates a different invention that was never contemplated or searched for previously, as all claims as originally examined required the “sealed” limitations. Therefore, the Examiner has never had to previously search for devices/implants without a container having a sealed region. If these claims were originally filed, then they would have been removed for a lack of Unity of Invention, as all shared limitations between original (and current) claim 1 and amended claim 11 can be found in at least US 2017/0120044, US 2016/0096012 and US 2020/0324108.
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claims 11-16 are withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03. Claims 22-27 remain withdrawn as not requiring all of the limitations of claim 1.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
Response to Arguments
Applicant’s amendments and arguments filed 2/6/2026 with respect to claim 1 have been fully considered and are persuasive. The 102 rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Sibary et al. (US 2017/0056646). The claim is NOT allowable because the applicant chose not to include all features of claim 2 that was previously indicated as allowable. As long as the portion has a malleable element, the claim is met.
Applicant’s amendments and arguments filed 2/6/2026 with respect to claim 5 have been fully considered and are persuasive. The 102 rejection has been withdrawn.
Regarding claims 5-7, the scope of claim 5 has been changed and is addressed below.
Regarding claim 11, the applicant chose not to include all features of claim 1. As such, the scope of the claim has been changed and has been withdrawn, as described above.
Claims 22-27 remain withdrawn as not requiring all of the limitations of claim 1.
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 5-7 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Pawsey (US 2017/0120044).
Regarding claims 5 and 6, Pawsey discloses an apparatus with a sterile container comprising a sealed region in which an implantable cochlear device as seen in figures 1B and 2 is contained prior to implantation, such that the container protects the device during transport until opened by a user (par. 0072). A stimulator unit 180 has a housing containing circuitry (par. 0043). A plurality of signal ports 148 (i.e., electrodes) are spaced from the housing and configured to be in electrical communication with the recipient’s cochlea (par. 0039, 0043). An assembly 189 extends from the stimulator unit housing to transmit signals between the circuitry and the signal ports, the assembly being a conductive wire having plurality of helical loops surrounded by silicone while in the sealed region (figure 2 and par. 0043). The helix region is only portion 189 and does not extend to the signal ports 148. The loops will be in that shape while in the sealed region. Each helical loop is 360 degrees, substantially planar in a plane substantially perpendicular to a longitudinal axis of the assembly, such that the coils are substantially parallel to one another. As per MPEP 2173.05(b) III. D., “substantially” is a broad term..
Regarding claim 7, Pawsey discloses the outer diameter of the assembly is no more than 3 mm (par. 0059). This would mean the radius of curvature of the helical coils would be no more than 1.5 mm.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 3, 4, 8-10, 18 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Carter (US 2020/0324108) in view of Sibary et al. (US 2017/0056646, hereinafter Sibary).
Regarding claims 1, 3, 8, 10, 18 and 19, Carter discloses an apparatus. The apparatus includes a cochlear medical device as seen in figures 2, 4 and 5 that is contained within a sealed region of a container prior to implantation and is opened by a user for implantation (par. 0032). The medical device comprises a housing containing stimulation circuitry 120 (par. 0044). An elongate assembly extends from the housing and transmits signals from the circuitry to a plurality of signal ports configured to be in communication with the recipient’s body. The signal ports are a silicone vestibular electrode array that can be inserted in a cochlea, if so desired by a user (par. 0021, 0025 and 0067). As seen in figures 4 and 5, the assembly has a plurality of substantially coplanar serpentine turns. The claim does not require a loop as the claims recites at least one loop “and/or” a plurality of serpentine turns. See annotated figure below:
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However, Carter is silent as to the portion further comprising a malleable element. Sibary discloses an analogous cochlear medical device with an elongate assembly as seen in figure 6. The assembly includes a portion with a malleable element 610 (par. 0072). Therefore, it would have been obvious to one of ordinary skill in the art before the applicant’s effective filing date to modify Carter to include a malleable element in the portion of the assembly in order to provide a dual role of resisting movement and enabling precise positioning (par. 0073 for motivation).
Regarding claim 4, the shape is maintained during transport, and a user may modify the shape after removal from the container by breaking the device before implantation.
Regarding claim 9, since the length of the serpentine portion is shown as 20-50 mm, the radius of curvature as shown will be between 1 and 15 mm.
Allowable Subject Matter
Claim 2 is 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.
Claims 11-16 would be allowable if the limitations from claim 1 that were removed by the applicant were added to claim 11.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Eric D Bertram whose telephone number is (571)272-3446. The examiner can normally be reached Monday-Friday 8am-6pm Central Time.
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, Jennifer McDonald can be reached at 571-270-3061. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Eric D. Bertram/Primary Examiner, Art Unit 3796
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