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 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 1, 3-10, and 12-18 are rejected under 35 U.S.C. 103 as being unpatentable over Haubert (US Pre-Grant Publication 2022/0040450), hereinafter ‘Haubert’, in view of Haller et al. (US Pre-Grant Publication 2010/0114288), hereinafter ‘Haller’.
Regarding claims 1 and 10, Haubert teaches a steerable medical device and an insertion procedure (see [0072], abstract), further comprising:
fastening a first magnet (magnet 515, Fig. 6) to a device (magnetic connector 610, Fig. 6);
coupling, via magnetic attraction, a second magnet to the first magnet (ferromagnetic wall of cylindrical hub 611, Fig. 6, [0076], magnetically attracting force towards wall);
applying an insertion force (compressive force 710, Fig. 7A) to the second magnet so as to cause the device to advance into the patient ([0040], surgical instrument inserted into body of patient);
wherein the magnetic attraction between the first and the second magnets defines an insertion force threshold which if exceeded by the insertion force causes the first and second magnets to release, preventing the insertion force from causing further insertion into the patient ([0079], when compressive force exceeds force created by the magnetic field, releases compressive force, [0077], excessive compression force due to the actuator continuing to compress the drive wire).
Haubert teaches that the steerable medical device is a catheter or endoscope (see Fig. 1A, [0057]) that can be inserted through a natural opening including an ear (see [0038]), but does not specifically disclose that the medical device is a cochlear implant electrode inserted into a cochlea of a subject.
Haller teaches a method of inserting a cochlear implant electrode (abstract, Fig. 9) comprising an electrode lead (cochlear lead 190, Fig. 1) and an electrode array (electrode array 195, Fig. 1) into a cochlea of a subject (see Fig. 8).
It would have been prima facie obvious before the effective filing date of the claimed invention to modify the catheter magnet system of Haubert for use in a cochlear implant insertion device, as in Haller. Doing so would provide a system to monitor forces to keep them below the threshold for tissue damage within the cochlea, as recognized by Haller [0046].
Regarding claims 3 and 12, Haubert and Haller teach the method/system of claims 1 and 10. Modified Haubert teaches the method/system further comprising:
calibrating the magnetic attraction to provide a desired insertion force threshold ([0059], threshold force is determined by strength of selected magnets).
Regarding claims 4 and 13, Haubert and Haller teach the method/system of claims 3 and 10. Modified Haubert teaches the method/system further comprising:
wherein calibrating the magnetic attraction includes adding a separation layer between the first magnet and the second magnet ([0076], altering thickness T1 of plunger wall to fine-tune breakaway force, Fig. 6).
Regarding claims 5 and 14, Haubert and Haller teach the method/system of claims 3 and 12. Modified Haubert teaches the method/system further comprising:
wherein calibrating the magnetic attraction includes selecting the first magnet and/or the second magnet from magnets of varying strength ([0081], use magnets of different strengths).
Regarding claims 6 and 15, Haubert and Haller teach the method/system of claims 1 and 10. Modified Haubert teaches the method/system further comprising:
a handle (handle 200, Figs. 1A-1B) attached to the second magnet ([0053], handle provides magnetic connectors 510), the method further comprising grasping of the handle whereby the handle is configured to be manipulated by an operator to advance the cochlear implant electrode into the cochlea (see Fig. 13).
Regarding claims 7 and 16, Haubert and Haller teach the method/system of claims 1 and 10. Modified Haubert teaches the method/system further comprising:
wherein the second magnet includes a handle (handle 200, Figs. 1A-1B, [0053], handle provides magnetic connectors 510), the method further comprising grasping of the handle whereby the handle is configured to be manipulated by an operator to advance the cochlear implant electrode into the cochlea (see Fig. 13).
Regarding claims 8 and 17, Haubert and Haller teach the method/system of claims 1 and 10. Modified Haubert teaches the method/system further comprising:
a plunger (sliding plunger 612, Fig. 7A) configured to move through a barrel (cylindrical space 613, Fig. 7A, [0075], slides longitudinally inside cylindrical space), the method further comprising fastening the second magnet to the plunger (see Fig. 7A, [0075], plunger moves within cylindrical hub).
Regarding claims 9 and 18, Haubert and Haller teach the method/system of claims 1 and 10. Modified Haubert teaches the method/system further comprising:
wherein the magnetic attraction corresponds to a maximum allowed insertion force, which if exceeded by the insertion force will cause the first and second magnet to decouple, stopping further insertion of the cochlear implant electrode into the cochlea ([0079], when compressive force exceeds force created by the magnetic field, releases compressive force, travels a distance of D1, [0094], stops instrument navigation).
Claims 2 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Haubert (US Pre-Grant Publication 2022/0040450) in view of Haller et al. (US Pre-Grant Publication 2010/0114288), further in view of Gleich et al. (US Pre-Grant Publication 2009/0299176), hereinafter ‘Gleich’.
Regarding claims 2 and 11, Haubert and Haller teach that the magnet is attached to the device (see Haubert Fig. 6), but do not specifically teach that the magnet is attached using a clip.
Gleich teaches a catheter (see Fig. 1) further comprising:
wherein fastening the first magnet to the electrode lead includes using a clip (clip 26, Fig. 2) to attach the first magnet to the electrode lead ([0049], magnet is fitted on catheter using clip).
It would have been prima facie obvious before the effective filing date of the claimed invention to have modified Haubert and Haller to incorporate the teachings of Gleich to include a clip to attach the magnet. Doing so would allow for the fitting of components so the device generates a magnetic field, as recognized by Gleich [0049].
Conclusion
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/E.L.O./Examiner, Art Unit 3792
/SHIRLEY X JIAN/Primary Examiner, Art Unit 3792
September 23, 2026
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