Prosecution Insights
Last updated: July 17, 2026
Application No. 18/000,202

ADJUSTABLE EXTENSION FOR MEDICAL IMPLANT

Final Rejection §102§103
Filed
Nov 29, 2022
Priority
Jun 22, 2020 — provisional 63/042,201 +1 more
Examiner
KOHUTKA, BROOKE NICOLE
Art Unit
3791
Tech Center
3700 — Mechanical Engineering & Manufacturing
Assignee
Cochlear Limited
OA Round
2 (Final)
43%
Grant Probability
Moderate
3-4
OA Rounds
3m
Est. Remaining
99%
With Interview

Examiner Intelligence

Grants 43% of resolved cases
43%
Career Allowance Rate
9 granted / 21 resolved
-27.1% vs TC avg
Strong +100% interview lift
Without
With
+100.0%
Interview Lift
resolved cases with interview
Typical timeline
3y 11m
Avg Prosecution
42 currently pending
Career history
73
Total Applications
across all art units

Statute-Specific Performance

§103
82.7%
+42.7% vs TC avg
§102
15.0%
-25.0% vs TC avg
§112
0.6%
-39.4% vs TC avg
Black line = Tech Center average estimate • Based on career data from 21 resolved cases

Office Action

§102 §103
DETAILED ACTION Response to Amendment This Office Action is responsive to the Amendment filed 3 March 2026. Claims 1, 4-11, 15-34 are now pending. The Examiner acknowledges the amendments to claims 1, 4, 5, 6, 7, 8, 9, 15, 16, 19, 20, 25, 26, 27, 28, 29, 30, as well as newly added claims 32-34. 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 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: -Claim 17 recites “a first portion” which is a generic placeholder. There is no sufficient structure for this limitation provided in the claims. The function of this limitation is to be in contact with a portion of a recipient’s auditory system. According to the specification the second element includes comprises a ball joint coupler, [0050] and equivalents thereof. - Claim 17 recites “a second portion” which is a generic placeholder. There is no sufficient structure for this limitation provided in the claims. The function of this limitation is to be in mechanical communication with a transducer. According to the specification the second element includes comprises a ball joint coupler, [0050] and equivalents thereof. -Claim 33 recites “a drive” which is a generic placeholder. There is no sufficient structure for this limitation provided in the claims. The function of this limitation is to adjust the transducer to controllably generate a pre-load. According to the specification the drive includes a Microdrive, compression unit, [0036] and equivalents thereof. 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 § 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. 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. 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: Claim(s) 17, 18, 19, 20, 21, 23, 24 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Schneider (U.S. 20050228213). Regarding Claim 17, Schneider teaches an apparatus comprising: a first portion configured to be in contact with a portion of a recipient's auditory system [Fig. 8, element 116 (mounting apparatus)] and [0025; “attachable to a patient’s skull”]; and a second portion configured to be in mechanical communication with a transducer and with the first portion such that the second portion is configured to be rotatably adjusted in at least one direction relative to the first portion [Fig. 8, element 314 (transducer housing)] and [0059]—includes the housing having a geometric shape for rotational movement, and rounded transducer housing. Regarding Claim 18, Schneider teaches wherein the second portion is configured to be rotatably adjusted in at least two directions relative to the first portion. [0006; “Rather, during rotation, any point on, …will reposition or will move relative to the mounting apparatus along an arc between first and second positions about the center of rotation….”] Regarding Claim 19, Schneider teaches wherein one of the first portion or the second portion comprises a male portion and the other of the first portion or the second portion comprises a female portion configured to engage the male portion [0074]—describes the male portions [Fig. 8, elements 806 and 808] of the second portion mating with the female portion [Fig. 8, elements 820 and 818] of the first portion. Regarding Claim 20, Schneider teaches wherein one of the first portion or the second portion comprises a ball [Fig. 8, element 314] and the other of the first portion or the second portion comprises a socket configured to engage the ball [Fig. 8, element 800 (cavity)]. Regarding Claim 21, Schneider teaches wherein the first portion is configured to be in contact with a portion of the otic capsule, a portion of the cochlea, a semicircular canal region, or an ossicle of the recipient [0054] and [Fig. 1]-depicts the first portion, element 116, in contact with the ossicle of the recipient by means of element 112. Regarding Claim 23, Schneider teaches wherein the ossicle comprises an incus or a stapes of the recipient [0054]—reference to the incus. Regarding Claim 24, Schneider teaches wherein the second portion is configured to rotate about an axis extending from the first portion to the second portion [0006]—reference to center of rotation, interpreted to be the axis extending from the first portion to the second portion, also shown as the axis line indicated in Fig. 8. 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. Claim(s) 1, 4, 5, 7, 8, 9, 15, 16, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34 is/are rejected under 35 U.S.C. 103 as being unpatentable over Schneider (U.S. 20050228213) in view of Leong (U.S. 20090087006). Regarding Claim 1, Schneider teaches an apparatus comprising: a transducer configured to be at least partially implanted on or within a recipient and in mechanical communication with a first region of the body of the recipient [0001]—reference to transducer and mounting system that rotatably cooperates to interface with a component of the auditory system; a first element configured to be at least partially implanted on or within the recipient [Figs. 4 and 5, element 402 (tube)] and [0002]—reference to implantable transducer, to which the tube is located within the implantable transducer, the first element configured to be in mechanical communication with the transducer [0062; “The tube 402 is appropriately sized to receive the actuator 112 …connected in a movable manner to the transducer housing 314 to permit a transducer driver to induce axial movements of the tube 402 and connected actuator 112.”], and an orifice [Fig. 4, element 408 (central aperture)] having a first length and extending from a first surface of the second portion to a second surface of the first element, See annotated Fig. 4 below; and a second element configured to be at least partially implanted on or within the recipient [Fig. 4, element 112 (actuator)], the second element comprising a first end and a second end with a second length therebetween, the second length longer than the first length, the second element configured to extend through the orifice, See annotated Figs. 4 and 5, and, during implantation, to be slidably adjusted relative to the orifice [0062; “The tube 402 is in turn connected in a movable manner to the transducer housing 314 to permit a transducer driver to induce axial movements of the tube 402 and connected actuator 112.”] and affixed to the first element such that the second end is in mechanical communication with a second portion of the body of the recipient [Fig. 4, element 416 (means for connecting the aperture)] and [0054]—discloses the actuator transmitting axial vibrations to the ossicles of the patient. PNG media_image1.png 868 704 media_image1.png Greyscale Schneider is silent on the first element comprising a first portion extending substantially parallel to a longitudinal axis of the transducer, a second portion extending substantially non- parallel to the longitudinal axis. Leong teaches the first element comprising a first portion extending substantially parallel to a longitudinal axis of the transducer [Fig. 3, elements 11 (transducer), 14 (first portion/first tube piece)], a second portion extending substantially non- parallel to the longitudinal axis [Fig. 3, element 18 (second portion/second tube piece)], [0016] and [0030]—discusses alignment and rotation of the tube pieces relative to the longitudinal axis of the connecting piece which is also parallel with the transducer. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include alignment and rotational capabilities of the portions of the structure as taught by Leong to allow for movement in the cavity as suggested by Schneider as Schneider discusses providing increased visibility, room and leverage while the device is within the cavity [0082] with Leong because Leong teaches the device being used for left and right ear configurations as well as different ear sizes [0030]. Regarding Claim 4, Schneider further teaches wherein the second element comprises a rod [0062]—reference to a pin. Regarding Claim 5, Schneider further teaches wherein the second element comprises a wire [0062]—reference to a wire. Regarding Claim 7, Schneider further teaches wherein the transducer comprises an actuator configured to generate mechanical vibrations that, upon the second element being affixed to the first element, propagate through the first element and the second element to the second portion of the body of the recipient [0054]—description of the vibrations transmitted to the ossicles via the transducer and actuator with further discussion on the transducer including a driver to contribute to stimulating the middle ear to create the sensation of sound. Regarding Claim 8, Schneider teaches wherein the transducer comprises a microphone configured to receive mechanical vibrations that, upon the second element being affixed to the first element, propagate from the second portion of the body of the recipient, through the first element and the second element, to the microphone [0056]—description of the microphone receiving acoustic signals and [0057]—which discloses the signals collected from the microphone then being processed via wire to the transducer to induce axial vibrations of the actuator. Regarding Claim 9, Schneider teaches further comprising a fixation element configured to be affixed to the first portion of the body of the recipient and in mechanical communication with the transducer such that an angular orientation of the transducer relative to the fixation element is configured to be controllably adjusted [0059]—includes description of rotational movement to angularly orient the transducer for interfacing the actuator with the ossicles [0058]—describing the components of a bracket that fix the apparatus to the patient’s skull and [0059]—which includes description of a means for angularly orienting the transducer for interfacing the actuator with the ossicles. Regarding Claim 15, Schneider teaches wherein the first portion of the body of the recipient comprises a portion of the recipient's skull and the second portion of the body of the recipient comprises an ossicle of the body of the recipient [0054]—reference to mounting apparatus connected to patient’s skull and reference to the ossicles and incus of the patient. Regarding Claim 16, Schneider teaches wherein at least a portion of the first element and at least a portion of the second element are configured to be implanted within a middle ear region of the body of the recipient, and the second end of the second element is configured to be in mechanical communication with an ossicle, a portion of the cochlea, or a semicircular canal of the body of the recipient [0054]—reference to the driver, included in the makeup of the transducer, and actuator used to stimulate an associated middle ear, in particular, an ossicle and incus bone. Also see Fig. 1 for placement inside the middle ear of both the first and second element with the second end of the second element interfacing with the ossicle (element 120)]. Regarding Claim 25, Schneider teaches a method comprising: at least partially implanting an assembly on or within a recipient such that the assembly is in mechanical communication with a first region of a recipient's body [0019; “retention apparatus for an implantable hearing aid transducer system is provided to capture a rotatable member in a desired angular orientation relative to an auditory component.”], the assembly comprising a transducer and a first element in mechanical communication with the transducer [Fig. 4, element 402 (tube) and 108 (transducer)], and a through-hole extending through the second portion [Fig. 4, element 408 (central aperture)]; adjusting a position of a second element within the through-hole such that second element extends out of both sides of the through-hole and the second element is in mechanical communication with a second region of the recipient's body [Fig. 12, element 1208 “transducer housing rotated within the cavity to align tube with a desired interface point on the incus”]—where the cavity and central aperture are considered synonymous and the actuator is interpreted as the second element; and affixing the first element and the second element to one another such that mechanical vibrations generated by the transducer propagate through the first element and the second element to the second region of the recipient's body [0054]—description of the vibrations transmitted to the ossicles via the transducer and actuator with further discussion on the transducer including a driver to contribute to stimulating the middle ear to create the sensation of sound. Schneider is silent on the first element comprising a first portion extending substantially parallel to a longitudinal axis of the transducer, a second portion extending substantially non-parallel to the longitudinal axis. Leong teaches the first element comprising a first portion extending substantially parallel to a longitudinal axis of the transducer [Fig. 3, elements 11 (transducer), 14 (first portion/first tube piece)], a second portion extending substantially non-parallel to the longitudinal axis [Fig. 3, element 18 (second portion/second tube piece)], [0016] and [0030]—discusses alignment and rotation of the tube pieces relative to the longitudinal axis of the connecting piece which is also parallel with the transducer. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include alignment and rotational capabilities of the portions of the structure as taught by Leong to allow for movement in the cavity as suggested by Schneider as Schneider discusses providing increased visibility, room and leverage while the device is within the cavity [0082] with Leong because Leong teaches the device being used for left and right ear configurations as well as different ear sizes [0030]. Regarding Claim 26, Schneider teaches wherein affixing the first element and the second element to one another comprises crimping a section of the second portion of the first element to onto the second element [0063; “FIG. 4, the means 416 may be a clamp that operates to compress the end of the tube 402 inward so that the end of the tube 402 engages the actuator 112 to connect the tube 402 and actuator 112 together.”] Regarding Claim 27, Schneider teaches wherein affixing the first element and the second element to one another comprises applying an adhesive to the first element, to the second element, or to the first element and to a portion of the second element or comprises clipping the first element and the second element to one another [0063]—reference to clamping the tube to attach and engage the actuator. Regarding Claim 28, Schneider teaches further comprises axially rotating the second element to mechanically couple the second element to a fixture affixed to the second region of the recipient's body [0059]—includes description of rotational movement to angularly orient the transducer for interfacing the actuator with the ossicles [0058]—describing the components of a bracket that fix the apparatus to the patient’s skull and [0059]—which includes description of a means for angularly orienting the transducer for interfacing the actuator with the ossicles. Regarding Claim 29, Schneider teaches wherein the transducer is between a position at which the first element is affixed to the second element and the second region of the recipient's body [Fig. 4]—due to the tube extending through the housing of the transducer and actuator, when considering the connecting at the end of the tube/central aperture denoted as 410, the transducer can be considered to be between this point and the second portion of the recipient’s body, indicated as the connection between 112 and 120 in Fig. 15. Regarding Claim 30, Schneider teaches wherein a position at which the first element is affixed to the second element is between the transducer and the second portion of the recipient's body [Fig. 4, 420 (recessed lip)]. Regarding Claim 31, Schneider teaches wherein the first element extends through the transducer [Fig. 4, element 402 (tube)]. Regarding Claim 32, Schneider is silent on wherein the second portion extends substantially perpendicular to the first portion [Fig. 3, elements 14 and 18 (first and second tube piece)] and [0026]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to align portions of the device perpendicular to one another as taught by Leong to allow adjustability in the ear canal as suggested by Schneider as Schneider discusses a repositioning feature of the apparatus in alternative to a pure rotational movement [0006] with Leong because Leong teaches the flexibility of the device being positioned in the recesses of the outer ear and securely in the auditory canal [0026]. Regarding Claim 33, Schneider teaches further comprising a fixation element mechanically connected to the first portion of the body of the recipient and configured to hold the transducer at a fixed depth relative to the fixation element [0075; “Rather compression of the spring…compressing the spring between the retaining member and the base.”], the fixation element comprising a drive configured to adjust the transducer to controllably generate a pre-load between the second element and the second portion of the body of the recipient [Fig. 10, element 810 (spring)] and [0075; “This in turn applies pressure on the transducer housing 314 to compressively capture the same in the cavity 800 between the lip 802 and base 812.”]—where the pressure is interpreted to be the pre-load. Regarding Claim 34, Schneider teaches wherein the first element comprises at least one protrusion extending outward from the longitudinal axis of the transducer [Fig. 9, elements 806 and 808 (detents)], the at least one protrusion mechanically affixed to the transducer [0074]—description of the twist lock type connection between retention and mounting apparatus and [0075; “following insertion of the transducer housing 314 into the cavity 800, the retention apparatus 302 is inserted such that the detents 806 and 808 travel along the longitudinal slots 814 and 816 until they come to rest at the bottom of the longitudinal slots 814 and 816.]—the transducer is located within the transducer housing and is therefore, in mechanical communication with the detents of the housing. Claim(s) 6, 10, 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Schneider (U.S. 20050228213) in view of Leong (U.S. 20090087006) and in further view of Bushek (U.S. 6325755). Regarding Claim 6, Schneider and Leong silent on wherein the second end comprises a clip configured to be attached to the second portion of the recipient's body. Bushek teaches wherein the second end comprises a clip configured to be attached to the second portion of the recipient's body [Col 11, lines 22-23]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to select a clip as an attachment means as taught by Bushek to attach the apparatus to the implantation area as suggested by Schneider and Leong, as Schneider presents means of attachment to a patient’s skull by using bone screws [0058] and Leong which discloses the use of adapters and various connecting means [0014] with Bushek because Bushek presents the clips as an alternative to bone screws [Col 11, lines 18-27]. Regarding Claim 10, Schneider and Leong are silent on wherein the fixation element comprises an adjustably rotatable coupler. Bushek teaches wherein the fixation element comprises an adjustably rotatable coupler [Col 3, lines 34-37]—includes description of the hanger and sleeve being rotatably and pivotally coupled. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to allow for the fixation element to be rotatably coupled as taught by Bushek to adjust positioning of the implant as suggested by Schneider and Leong, as Schneider discusses challenges with attempting to position an implantable auditory device [0004] and Leong which discloses using the device for either ear and/or for different ear sizes [0030] with Bushek because Bushek teaches this feature for allowing adjustability within the implantation area [Col 3, lines 43-45]. Regarding Claim 11, Schneider and Leong are silent on wherein the fixation element comprises an adjustably bendable coupler. Bushek teaches wherein the fixation element comprises an adjustably bendable coupler [Col 3, lines 47-52]—reference to bendable flanges. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to allow for the fixation element to be flexibly coupled as taught by Bushek to adjust positioning of the implant as suggested by Schneider and Leong, as Schneider discusses a movable connection between the transducer and housing [0069] and Leong which discusses the use of hearing aids in the auditory canal along with implantable hearing aids [0003] with Bushek because Bushek teaches increasing the additional sites and positions for mounting in the implantation area [Col 3, lines 49-52]. Claim(s) 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Schneider (U.S. 20050228213) and in further view of Bushek (U.S. 6325755). Regarding Claim 22, Schneider is silent on wherein the portion of the cochlea comprises a round window, an oval window, an artificial window, or a promontory. Bushek teaches wherein the portion of the cochlea comprises a round window, an oval window, an artificial window, or a promontory [Col 8, lines 3-7; “A resulting electrical signal is provided to an electrical-to-mechanical piezoelectric output transducer that generates a mechanical vibration coupled to a separate element of ossicular chain 38 or to oval window 98 or round window 102.”] It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to an anatomical area of the cochlea as taught by Bushek to connect the implant to as suggested by Schneider, as Schneider discusses vibrating bones of the ossicles to stimulate the cochlea and the oval window [0069] with Bushek because Bushek teaches fluidic motion generating pressure in the cochlea by means of the round window [Col 6, lines 20-25]. Response to Arguments Applicant's arguments filed 3 March 2026 with respect to the drawing and claim objections have been fully considered and are persuasive in light of the amendments. Applicant's comments filed 3 March 2026 with respect to 35 U.S.C. 112(f) are acknowledged. Applicant’s arguments filed 3 March 2026 with respect to the rejection of claims 1-16 and 27 under 35 U.S.C.112(b) have been fully considered and are persuasive in light of the amendments for claims 1, 4-9, 15-16, 10-20, 25-30. Applicant’s arguments filed 3 March 2026 with respect to the rejection of claims 1-5, 7-9, 12-16, and 25-31 under 35 U.S.C.102(a)(1) have been fully considered and are persuasive, however new grounds of rejection are presented above in light of the amendments. Applicant’s arguments filed 3 March 2026 with respect to the rejection of claims 17-21 and 23-24 under 35 U.S.C.102(a)(1) have been fully considered but are not persuasive. Regarding Claim 17, applicant contends that Schneider does not teach “a first portion configured to be in contact with a portion of a recipient’s auditory system”. The examiner provided reference to [0054] which discusses attachment to the patient’s skull. The skull includes the temporal bone which is a part of the recipient’s auditory system. The applicant makes various references to the skull of the recipient throughout the disclosure [0017, 0029, 0031, 0035, 0037-0039, and 0053]. The applicant also contends that the examiner is interpreting the actuator as part of the mounting apparatus. The examiner clarifies that the interpretation in the body of the rejection includes reference to [Fig. 8, element 116 (mounting apparatus)] and [0025; “attachable to a patient’s skull”] and [Fig. 8, element 314 (transducer housing)] and [0059]—includes the housing having a geometric shape for rotational movement, and rounded transducer housing. This does not include any interpretation of an actuator as part of the mounting apparatus but rather the transducer housing having rotational movement within the mounting apparatus where the mounting apparatus is interpreted to be the first portion and the housing apparatus interpreted to be the second portion. The applicant further contends that the examiner is interpreting the actuator as part of the mounting apparatus in reference to “the first portion” and that the transducer housing and actuator are not configured to be rotatably adjusted relative to the actuator. The examiner clarifies that the interpretation in the body of the rejection does not include any interpretation of an actuator as part of the mounting apparatus but rather the transducer housing having rotational movement within the mounting apparatus where the mounting apparatus is interpreted to be the first portion and the housing apparatus interpreted to be the second portion. The actuator is not involved in the body of the rejection. In view of the foregoing, the previously presented rejections for claims 17-21 and 23-24 citing Schneider are maintained. Applicant’s arguments filed 3 March 2026 with respect to the rejection of claims 6, 10, 11 under 35 U.S.C.103 have been fully considered and are persuasive in light of the amendments. New rejections are presented for claims 6, 10-11 citing Schneider in view of Leong and in further view of Bushek, and for claim 22 citing Schneider in view of Bushek. Applicant’s arguments filed 3 March 2026 with respect to the rejection of Claim 22 under 35 U.S.C.103 have been fully considered and are not persuasive. In view of the arguments presented in regards to claim 17, the previously presented rejections citing Schneider in view of Bushek are maintained. Conclusion Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a). A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action. Any inquiry concerning this communication or earlier communications from the examiner should be directed to BROOKE NICOLE KOHUTKA whose telephone number is (571)272-5583. The examiner can normally be reached Monday-Friday 7:30am-5:00pm EST. 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, Charles Marmor II can be reached at 571-272-4730. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /B.N.K./Examiner, Art Unit 3791 /CHRISTINE H MATTHEWS/Primary Examiner, Art Unit 3791
Read full office action

Prosecution Timeline

Nov 29, 2022
Application Filed
Dec 15, 2025
Non-Final Rejection mailed — §102, §103
Mar 03, 2026
Response Filed
Jun 02, 2026
Final Rejection mailed — §102, §103 (current)

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Patent 12642531
IMPLANTABLE SPHINCTER ASSISTANCE DEVICE WITH DUAL ZONE CONTROLLED RATE OF CONSTRICTION FORCE
4y 5m to grant Granted Jun 02, 2026
Patent 12582402
IMPLANTABLE SPHINCTER ASSISTANCE DEVICE WITH SINGLE USE EMERGENCY RELEASE DECOUPLING INTERCONNECTION LINK
4y 3m to grant Granted Mar 24, 2026
Patent 12575832
IMPLANTABLE SPHINCTER ASSISTANCE DEVICE WITH 3D PRINTED OR MIM UNIBODY HOUSING
4y 3m to grant Granted Mar 17, 2026
Patent 12564406
IMPLANTABLE SPHINCTER ASSISTANCE DEVICE WITH BIMODAL CIRCUMFERENTIAL RESTRICTION FORCE THRESHOLD
4y 2m to grant Granted Mar 03, 2026
Patent 12521119
IMPLANTABLE SPHINCTER ASSISTANCE DEVICE WITH BIMODAL DISTRIBUTION OF MAGNETIC FIELD INTENSITY RATE-OF-CHANGE
4y 0m to grant Granted Jan 13, 2026
Study what changed to get past this examiner. Based on 5 most recent grants.

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Prosecution Projections

3-4
Expected OA Rounds
43%
Grant Probability
99%
With Interview (+100.0%)
3y 11m (~3m remaining)
Median Time to Grant
Moderate
PTA Risk
Based on 21 resolved cases by this examiner. Grant probability derived from career allowance rate.

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