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 .
Election/Restrictions
Applicant's election with traverse of claims 16-18, 20-22, and 24 (Invention III) and species C (Fig. 6C) in the reply filed on 07/28/2026 is acknowledged. The traversal is on the ground(s) that Applicant argues on page 2 that “First, there is no addressment of why Gorup III lacks unity of invention with Group II. Check it out. All that Art Unit 3796 does is address Group I… We are a thorough sort, and recognize that we are fallible. Maybe we missed something. Doubtful, but who knows. We therefore ask Art Unit 3796, if it insists on only examining one independent claim, to identify, on the record, where it addresses the alleged lack of Unity between Group II and Group III in the document issued on May 29, 2026.”.
This is not found persuasive because the technical features are the implantable device with electrodes and a carrier, as these are the shared technical features, and which is addressed as to break the groups’ unity of invention.
Applicant then cites on pages 3-4 that “As provided in 37 CFR 1.475 (b), a national stage application containing claims to different categories of invention will be considered to have unity of invention if the claims are drawn only to one of the following combinations of categories” from the Restriction notice filed 05/29/2026 and argues that the Examiner did not address the “will be” aspect of the consideration of the unity of the invention.
Examiner disagrees. Examiner has made it explicit in the OA that the unity of the invention are the technical features, as cited in the OA and above, which Examiner proceeded to break unity, by providing art showing that these features are known in the art.
Applicant then argues on pages 4-5 that “There is no support for this. None at all. FIG. 6A could be a 24 inch tire and FIG. 6B could be a 25 inch tire and every word in the above could correspond to such… This is arbitrary and capricious, thus violating the Administrative Procedures Act (APA) to which the USPTO is bound pursuant to the Supreme Court's Ruling in Zurko… What is the generic invention? You do not say. Why are they not SO linked to form a single general inventive concept? You do not say. Indeed, how about we start with an explanation of what Art Unit 3796 believes is meant by "a single general inventive concept?
This is stock OACs language. We are not stock attorneys.”
Examiner disagrees because the instant specification clarifies the different embodiments of the actuator as 630, 640, and 650 as shown in Figs. 6A-C. Examiner has not violated APA pursuant to the precedented Zurko ruling because the Examiner has not taken Official Notice, but rather, cited Catilho to break Unity of the Invention. Examiner has provided the evidence. As noted above, the technical features make up the general inventive concept.
The requirement is still deemed proper and is therefore made FINAL.
Claims 1-9, 11-13, and 15 withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 07/28/2026.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 09/16/2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Objections
Claim 18, 20, and 24 are objected to because of the following informalities: there is an issue with the word “respectively” because “and/or” is used so there are no two clearly paired items. Appropriate correction is required.
Claim 18 is objected to because of the following informalities: the phrase “the relieving of tension increasing the local radius and/or establishing the local radius of curvature” is grammatically sound and should be amended to recite “the relieving of tension increases the local radius and/or establishes the local radius of curvature”. 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 16-18, 20-22, and 24 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.
Regarding claim 16, it is unclear of the “electrodes” on the carrier of line 2 are the same or different than the “plurality of electrodes” of line 2.
Regarding claim 21, it is unclear of the “recipient” of line 3 are the same or different than the “recipient” of claim 16.
Regarding claim 21, it is unclear what “that…beyond that which results from tissue of the recipient causing such change and/or adoption” of line 3 is and what “that” means, and what is “such change”. Is the term “adoption” correct or did Applicant mean “adaptation”. It is unknow what adaptation or change is “beyond that”. It is further unclear why there is a list on i and/or ii to pick from.
Regarding claim 21, the phrase “no radius of curvature” is ambiguous as this can mean zero radius, infinite radius, undefined radius, or a straight segment. Examiner suggest clarifying that the carrier’s intended orientation be straight.
Claim 21 recites the limitation "the respective plurality of spatially separate locations" in lines 8-9. There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 22, it is unclear what the “three” are referring to. Examiner suggests clarifying that the claim refers to 3 locations.
Claim 17-18, 20-22, and 24 are rejected for being dependent on rejected independent claim 16.
Claim Interpretation
Regarding claim 16, the phrase “can be simultaneously controllably changed relative to one another” will be treated as intended use because the claim fails to provide structure that is configured to do function of “simultaneously controllably changed” (functional language).
If an examiner concludes that a functional limitation is an inherent characteristic of the prior art, then to establish a prima case of anticipation or obviousness, the examiner should explain that the prior art structure inherently possesses the functionally defined limitations of the claimed apparatus. In re Schreiber, 128 F.3d at 1478, 44 USPQ2d at 1432. See also Bettcher Industries, Inc. v. Bunzl USA, Inc., 661 F.3d 629, 639-40,100 USPQ2d 1433, 1440 (Fed. Cir. 2011). The burden then shifts to applicant to establish that the prior art does not possess the characteristic relied on. In re Schreiber, 128 F.3d at 1478, 44 USPQ2d at 1432; In re Swinehart, 439 F.2d 210, 213, 169 USPQ 226, 228 (CCPA 1971). See MPEP 2114(I).
In the instant case in Pawsey, Fig. 3A shows the electrode array (structure) with the marked different local radius curvature at locations 1 and 2 simultaneously, which shows that the capability of the locations being controlled and different/changed due to their different local radius curvature.
Claim Rejections - 35 USC § 102
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.
Claim(s) 16, 18, and 21-22 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Pawsey et al. (US 20180050196)(Hereinafter Pawsey).
Regarding claim 16, Pawsey teaches An implantable apparatus (Abstract “An apparatus including an actuator and an electrode array support”), comprising:
an electrode array including a plurality of electrodes and a carrier carrying electrodes ([0075] “Integrated in electrode assembly 145 is an array 146 of longitudinally-aligned and distally extending electrode contacts 148 for stimulating the cochlea by delivering electrical, optical, or some other form of energy.” Fig. 3A The carrier carrying electrode is the “electrode assembly 145 and the electrode contacts 148 are the plurality of electrodes.),
wherein the electrode array is configured so that, during and/or after insertion into a recipient, a local radius of curvatures at a first location and a second location more distal than the first location can be simultaneously controllably changed relative to one another (
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[0084] “Returning to FIGS. 3A-3B, perimodiolar electrode assembly 145 is pre-curved in a direction that results in electrode contacts 148 being located on the interior of the curved assembly, as this causes the electrode contacts to face the modiolus when the electrode assembly is implanted in or adjacent to cochlea 140.” [0353] “with respect to an insertion regime where the electrode array will be inserted to have a specific insertion angle, impedance between the pertinent electrodes can be monitored and when an impedance is measured that is indicative of the electrode array reaching the desired insertion angle, further advancement electrode array is halted by halting actuation of actuator 7720 for example [locations can be simultaneously controllably changed].” Examiner notes that Fig. 3 A shows that complete insertion into the recipient (cochlea). The local radius of curvatures at location 1 (which is more distal) is much lower than the local radius of curvatures at location 2 because the radius of the first arrow is much smaller than the radius of the second location. This can be determined by mentally drawing a circle where the edge of the circle aligns with the selected location, and this will show that the circle of location 1 is smaller than the circle of location 2. A smaller circle indicates a smaller radius, and a bigger circle indicates a larger radius because circumference is directly proportional to the radius (C=2 pi r). Examiner notes that no structure is recited associated with what mechanism does the simultaneously controllable change of the two locations, but notes that the simultaneous change must occur to be able to insert into the cochlea.).
Regarding claim 18, Pawsey teaches wherein: the local radius of curvature at the first location is controlled by relieving a tension force in the carrier, the relieving of tension increasing the local radius and/or establishing the local radius of curvature, respectively (Intended use. No structure is recited that is capable of doing the claimed function. [0343] “Note also that the status of the electrode array determined in action 9420 could be that of a tip fold over or a buckling or a twisting of the electrode array, etc.” [0353] “with respect to an insertion regime where the electrode array will be inserted to have a specific insertion angle, impedance between the pertinent electrodes can be monitored and when an impedance is measured that is indicative of the electrode array reaching the desired insertion angle, further advancement electrode array is halted by halting actuation of actuator 7720 for example [established local radius of curvature].”).
Regarding claim 21, Pawsey teaches wherein: the electrode array is configured so that, after insertion into a recipient, beyond that which results from tissue of the recipient causing such change and/or adoption, (i) a plurality of local radius of curvatures at a plurality of spatially separate locations, including the first location and the second location, can be controllably changed to be different from one another and/or (ii) the plurality of local radius of curvatures can be controllably obtained at the plurality of spatially separate locations from no radius of curvature at the respective plurality of spatially separate locations (
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[0341] “s noted above, some exemplary scenarios can exist where the deleterious result of an electrode array piercing a wall of the cochlea (other than where the cochleostomy is present) can occur as a result of the advancement process of the electrode array. Accordingly, an exemplary embodiment of method action 9320 can entail that the electrode array is continued to be advanced along at given trajectory, it is on a trajectory that could result in the electrode array piercing the wall, that being the status of the electrode array.” [0084] “Returning to FIGS. 3A-3B, perimodiolar electrode assembly 145 is pre-curved in a direction that results in electrode contacts 148 being located on the interior of the curved assembly, as this causes the electrode contacts to face the modiolus when the electrode assembly is implanted in or adjacent to cochlea 140.” Examiner notes that Fig. 3 A shows that complete insertion into the recipient (cochlea). The local radius of curvatures at location 1 is much lower than the local radius of curvatures at location 2 because the radius of the first arrow is much smaller than the radius of the second location. This can be determined by mentally drawing a circle where the edge of the circle aligns with the selected location, and this will show that the circle of location 1 is smaller than the circle of location 2. A smaller circle indicates a smaller radius, and a bigger circle indicates a larger radius because circumference is directly proportional to the radius (C=2 pi r). Examiner notes that no structure is recited associated with what mechanism does the simultaneously controllable change of the two locations.).
Regarding claim 22, Pawsey teaches wherein: the plurality of spatially separate locations include at least three (
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Examiner notes there are a plurality of locations, and notes 3 locations in the drawing.).
Claim(s) 16, 18 and 21-22 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wallace et al. (US 8843216)(Hereinafter Wallace).
Regarding claim 16, Wallace teaches An implantable apparatus (Claim 1 “An implantable electrode array assembly”), comprising:
an electrode array including a plurality of electrodes and a carrier carrying electrodes (Claim 1 “an elongated carrier having a proximal end, a distal end, and an inner surface; a plurality of electrodes mounted within the carrier, at least one of the electrodes having a surface that is adjacent the inner surface of the carrier”),
wherein the electrode array is configured so that, during and/or after insertion into a recipient, a local radius of curvatures at a first location and a second location more distal than the first location can be simultaneously controllably changed relative to one another (Claim 1 “the actuator being configured to adjust a curvature of the carrier, wherein the curvature is adjustable by applying the electric potential to the actuator.” Examiner notes that no structure is recited associated with what mechanism does the simultaneously controllable change of the two locations but notes that the actuator can change the curvature of the carrier at different locations simultaneously with the single actuator.).
Regarding claim 18, Wallace teaches wherein: the local radius of curvature at the first location is controlled by relieving a tension force in the carrier, the relieving of tension increasing the local radius and/or establishing the local radius of curvature, respectively (Intended use. No structure is recited that is capable of doing the claimed function. Claim 14 “wherein the plurality of electrodes are designed to conform with an inner wall of a cochlea and the assembly is preformed into a curved configuration and wherein the actuator provides a force to maintain the assembly in a straight configuration when subject to the electric potential.”).
Regarding claim 21, Wallace teaches wherein: the electrode array is configured so that, after insertion into a recipient, beyond that which results from tissue of the recipient causing such change and/or adoption, (i) a plurality of local radius of curvatures at a plurality of spatially separate locations, including the first location and the second location, can be controllably changed to be different from one another and/or (ii) the plurality of local radius of curvatures can be controllably obtained at the plurality of spatially separate locations from no radius of curvature at the respective plurality of spatially separate locations (Claim 15 “wherein the curved configuration is such that the carrier can fit inside the cochlea of an implantee with said surface of said at least one of the electrodes adjacent the inner surface being oriented to face the modiolus of the cochlea.” Claim 1 “the actuator being configured to adjust a curvature of the carrier, wherein the curvature is adjustable by applying the electric potential to the actuator.” Examiner notes that no structure is recited associated with what mechanism does the simultaneously controllable change of the three locations but notes that the actuator can change the curvature of the carrier at different locations.).
Regarding claim 22, Wallace teaches wherein: the plurality of spatially separate locations include at least three (Claim 15 “Claim 1 “the actuator being configured to adjust a curvature of the carrier, wherein the curvature is adjustable by applying the electric potential to the actuator.” Examiner notes that no structure is recited associated with what mechanism does the simultaneously controllable change of the two locations but notes that the actuator can change the curvature of the carrier at different locations” Examiner notes there are a plurality of locations in the modiolus of the cochlea, and notes 3 locations out of many locations along the array.).
Claim Rejections - 35 USC § 103
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.
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pawsey et al. (US 20180050196)(Hereinafter Pawsey) in view of Bernhard et al. (US 20120303097)(Hereinafter Bernhard).
Regarding claim 17, Pawsey teaches wherein: the local radius of curvature at the first location is controlled by one or more actuators located, relative to a longitudinal direction of the electrode array, … ([0341] “controlling at least one of the actuator or another actuator to change a trajectory of the electrode array insertion based on the determination.”).
However, Pawsey does not teach actuator between two electrodes. Bernhard, in the same field of endeavor, teaches an implantable electrode array with an elongated carrier and an actuator implanted into the cochlea (Abstract and Fig. 8), and further teaches actuator between two electrodes (Fig. 8 where actuator 20 is between electrode 96 on the left and right. [0044] “the two electrodes 96 adjacent to the actuator 20 may be excited simultaneously in a manner so as to create a virtual electrode in-between that two electrodes”) to accurately steer the carrier into the cochlea ([0044]). It would have been obvious to one skilled in the art, prior to the effective filing date of the invention, to modify the device of Pawsey, with the actuator between two electrodes of Bernhard, because such a modification would allow to accurately steer the carrier into the cochlea.
Claim(s) 20, and 24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pawsey et al. (US 20180050196)(Hereinafter Pawsey) in view of Wallace et al. (US 8843216)(Hereinafter Wallace).
Regarding claim 20, Pawsey teaches wherein: the local radius of curvature at the first location is controlled by actuators …, wherein upon turning off the actuators, the local radius of curvature is increased and/or the local radius of curvature is established, respectively ([0353] “with respect to an insertion regime where the electrode array will be inserted to have a specific insertion angle, impedance between the pertinent electrodes can be monitored and when an impedance is measured that is indicative of the electrode array reaching the desired insertion angle, further advancement electrode array is halted by halting actuation of actuator 7720 for example [established local radius of curvature].”).
However, Pawsey does not teach actuators in the carrier. Wallace, in the same field of endeavor, teaches an implantable electrode array with an elongated carrier and an actuator implanted into the cochlea (Abstract), and further teaches actuators in the carrier (Col.9 lines 43-47 “FIG. 7 illustrates a number of polymer actuators in which the 25 micron platinum wire is wound at different pitches or omitted altogether. In actuator 120 the wire was wound at 25 turns/cm, actuator 122 at 15 turns/cm, actuator 124 at 10 turns/cm and in actuator 126 the wire 102 is omitted.” Fig. 9 shows actuator 114 attached to the carrier 116 which is between each electrode, thereby being between 2 electrodes.) to avoid damaging the sensitive structures of the cochlea (Col. 1 lines 25-26). It would have been obvious to one skilled in the art, prior to the effective filing date of the invention, to modify the device of Pawsey, with the actuators in the carrier of Wallace, because such a modification would allow to avoid damaging the sensitive structures of the cochlea.
Regarding claim 24, Pawsey teaches wherein: the local radius of curvature at the first location is controlled by actuators …, wherein upon turning on the actuators, the local radius of curvature is increased and/or the local radius of curvature is established, respectively ([0341] “entails determining a status of the electrode array based on the monitored electrical phenomenon/characteristics. Method 9400 further includes method action 9430, which entails controlling at least one of the actuator or another actuator to change a trajectory of the electrode array insertion based on the determination.”).
However, Pawsey does not teach actuators in the carrier. Wallace, in the same field of endeavor, teaches an implantable electrode array with an elongated carrier and an actuator implanted into the cochlea (Abstract), and further teaches actuators in the carrier (Col.9 lines 43-47 “FIG. 7 illustrates a number of polymer actuators in which the 25 micron platinum wire is wound at different pitches or omitted altogether. In actuator 120 the wire was wound at 25 turns/cm, actuator 122 at 15 turns/cm, actuator 124 at 10 turns/cm and in actuator 126 the wire 102 is omitted.” Fig. 9 shows actuator 114 attached to the carrier 116 which is between each electrode, thereby being between 2 electrodes.) to avoid damaging the sensitive structures of the cochlea (Col. 1 lines 25-26). It would have been obvious to one skilled in the art, prior to the effective filing date of the invention, to modify the device of Pawsey, with the actuators in the carrier of Wallace, because such a modification would allow to avoid damaging the sensitive structures of the cochlea.
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 16, 18, and 21-22 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 15 of U.S. Patent No. US 8843216 (Hereinafter ‘216). Although the claims at issue are not identical, they are not patentably distinct from each other because:
Regarding claim 16, ‘216 teaches An implantable apparatus (Claim 1 “An implantable electrode array assembly”), comprising:
an electrode array including a plurality of electrodes and a carrier carrying electrodes (Claim 1 “an elongated carrier having a proximal end, a distal end, and an inner surface; a plurality of electrodes mounted within the carrier, at least one of the electrodes having a surface that is adjacent the inner surface of the carrier”),
wherein the electrode array is configured so that, during and/or after insertion into a recipient, a local radius of curvatures at a first location and a second location more distal than the first location can be simultaneously controllably changed relative to one another (Claim 1 “the actuator being configured to adjust a curvature of the carrier, wherein the curvature is adjustable by applying the electric potential to the actuator.” Examiner notes that no structure is recited associated with what mechanism does the simultaneously controllable change of the two locations but notes that the actuator can change the curvature of the carrier at different locations.).
Regarding claim 18, ‘261 teaches wherein: the local radius of curvature at the first location is controlled by relieving a tension force in the carrier, the relieving of tension increasing the local radius and/or establishing the local radius of curvature, respectively (Intended use. No structure is recited that is capable of doing the claimed function. Claim 14 “wherein the plurality of electrodes are designed to conform with an inner wall of a cochlea and the assembly is preformed into a curved configuration and wherein the actuator provides a force to maintain the assembly in a straight configuration when subject to the electric potential.”).
Regarding claim 21, ‘261 teaches wherein: the electrode array is configured so that, after insertion into a recipient, beyond that which results from tissue of the recipient causing such change and/or adoption, (i) a plurality of local radius of curvatures at a plurality of spatially separate locations, including the first location and the second location, can be controllably changed to be different from one another and/or (ii) the plurality of local radius of curvatures can be controllably obtained at the plurality of spatially separate locations from no radius of curvature at the respective plurality of spatially separate locations (Claim 15 “wherein the curved configuration is such that the carrier can fit inside the cochlea of an implantee with said surface of said at least one of the electrodes adjacent the inner surface being oriented to face the modiolus of the cochlea.” Claim 1 “the actuator being configured to adjust a curvature of the carrier, wherein the curvature is adjustable by applying the electric potential to the actuator.” Examiner notes that no structure is recited associated with what mechanism does the simultaneously controllable change of the three locations but notes that the actuator can change the curvature of the carrier at different locations.).
Regarding claim 22, ‘261 teaches wherein: the plurality of spatially separate locations include at least three (Claim 15 “Claim 1 “the actuator being configured to adjust a curvature of the carrier, wherein the curvature is adjustable by applying the electric potential to the actuator.” Examiner notes that no structure is recited associated with what mechanism does the simultaneously controllable change of the two locations but notes that the actuator can change the curvature of the carrier at different locations” Examiner notes there are a plurality of locations in the modiolus of the cochlea, and notes 3 locations out of many locations along the array.).
Claims 20, and 24 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 32 of U.S. Patent No. US 8843216 (Hereinafter ‘216) in view of Pawsey et al. (US 20180050196)(Hereinafter Pawsey). Although the claims at issue are not identical, they are not patentably distinct from each other because:
Regarding claim 20, ‘261 teaches wherein: the local radius of curvature at the first location is controlled by actuators on the carrier (Claim 1 “the actuator being configured to adjust a curvature of the carrier, wherein the curvature is adjustable by applying the electric potential to the actuator.” Claim 32 “an actuator incorporating light sensitive gels in the form of a bimorph or other actuator array for which a change in chemical structure is optically induceable [actuators]’).
However, ‘261 does not teach wherein upon turning off the actuators, the local radius of curvature is increased and/or the local radius of curvature is established, respectively. Pawsey, in the same field of endeavor, teaches an implantable electrode array with an elongated carrier and an actuator implanted into the cochlea (Abstract), and further teaches wherein upon turning off the actuators, the local radius of curvature is increased and/or the local radius of curvature is established, respectively ([0353] “with respect to an insertion regime where the electrode array will be inserted to have a specific insertion angle, impedance between the pertinent electrodes can be monitored and when an impedance is measured that is indicative of the electrode array reaching the desired insertion angle, further advancement electrode array is halted by halting actuation of actuator 7720 for example [established local radius of curvature].”). to avoid damaging the sensitive structures of the cochlea ([0165]). It would have been obvious to one skilled in the art, prior to the effective filing date of the invention, to modify the device of ‘261, with wherein upon turning off the actuators, the local radius of curvature is increased and/or the local radius of curvature is established, respectively of Pawsey, because such a modification would allow to avoid damaging the sensitive structures of the cochlea.
Regarding claim 24, ‘261 teaches wherein: the local radius of curvature at the first location is controlled by actuators on the carrier (Claim 1 “the actuator being configured to adjust a curvature of the carrier, wherein the curvature is adjustable by applying the electric potential to the actuator.” Claim 32 “an actuator incorporating light sensitive gels in the form of a bimorph or other actuator array for which a change in chemical structure is optically induceable [actuators]’).
However, ‘261 does not teach wherein upon turning on the actuators, the local radius of curvature is increased and/or the local radius of curvature is established, respectively. Pawsey, in the same field of endeavor, teaches an implantable electrode array with an elongated carrier and an actuator implanted into the cochlea (Abstract), and further teaches wherein upon turning on the actuators, the local radius of curvature is increased and/or the local radius of curvature is established, respectively ([0341] “entails determining a status of the electrode array based on the monitored electrical phenomenon/characteristics. Method 9400 further includes method action 9430, which entails controlling at least one of the actuator or another actuator to change a trajectory of the electrode array insertion based on the determination.”) to avoid damaging the sensitive structures of the cochlea ([0165]). It would have been obvious to one skilled in the art, prior to the effective filing date of the invention, to modify the device of ‘261, with wherein upon turning on the actuators, the local radius of curvature is increased and/or the local radius of curvature is established, respectively of Pawsey, because such a modification would allow to avoid damaging the sensitive structures of the cochlea.
Claims 17 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 of U.S. Patent No. US 8843216 (Hereinafter ‘216) in view of Bernhard et al. (US 20120303097)(Hereinafter Bernhard). Although the claims at issue are not identical, they are not patentably distinct from each other because:
Regarding claim 17, ‘261 teaches wherein: the local radius of curvature at the first location is controlled by one or more actuators located, relative to a longitudinal direction of the electrode array, … (Claim 1 “the actuator being configured to adjust a curvature of the carrier, wherein the curvature is adjustable by applying the electric potential to the actuator.” Fig. 9 shows actuator 114 attached to the carrier 116 which is between each electrode, thereby being between 2 electrodes.).
However, ‘261 does not teach actuator between two electrodes. Bernhard, in the same field of endeavor, teaches an implantable electrode array with an elongated carrier and an actuator implanted into the cochlea (Abstract and Fig. 8), and further teaches actuator between two electrodes (Fig. 8 where actuator 20 is between electrode 96 on the left and right. [0044] “the two electrodes 96 adjacent to the actuator 20 may be excited simultaneously in a manner so as to create a virtual electrode in-between that two electrodes”) to accurately steer the carrier into the cochlea ([0044]). It would have been obvious to one skilled in the art, prior to the effective filing date of the invention, to modify the device of ‘261, with the actuator between two electrodes of Bernhard, because such a modification would allow to accurately steer the carrier into the cochlea.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Stieghort et al. (US 11235164)
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MOUSSA M HADDAD whose telephone number is (571)272-6341. The examiner can normally be reached M-TH 8:00-6:00.
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/MOUSSA HADDAD/Examiner, Art Unit 3796
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