DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Status
Applicant’s Remarks and Amendments filed 25 February 2026 have been entered. Claims 1-13 are pending.
Response to Arguments
Applicant’s arguments, see remarks, filed 25 February 2026, with respect to the rejection(s) of claim(s) 1 under U.S.C. 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of newly found prior art references.
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.
Claims 1-13 are rejected under 35 U.S.C. 103 as being unpatentable over Steinhardt et al. (US 2019/0201189 A1), “Steinhardt” in view of Huettenbrink et al. (US 2018/0104048 A1), “Huettenbrink”, and further in view of Lenarz et al. (US 2012/0078368 A1), “Lenarz”.
Regarding claim 1, Steinhardt teaches auditory ossicle prosthesis (Fig. 3E, middle ear prosthesis (MEP) 300) comprising: a head element (Fig. 3E, head end 301), which is provided for an arrangement on an eardrum (Figs. 4A-B, MEP 300 is fitted over stapes 204); and a clamp having two clamping jaws (Fig. 3E, engagement legs 303) configured to be clamped to an auditory ossicle (Figs. 4A-B, MEP 300 is fitted over stapes 204), so that the auditory ossicle is between the two clamping jaws (Figs. 4A-B) and the auditory ossicle prosthesis is clamped to the auditory ossicle (Figs. 4A-B, MEP 300 replaces a portion of the ossicular chain in the middle ear [0020]), and that one head part is connected to one clamping jaw (Fig. 3E, left side of head end 301 is connected to left engagement leg 303) and another head part is connected to another clamping jaw (Fig. 3E, right side of head end 301 is connected to right engagement leg 303), but fails to teach wherein the head element has several head parts configured to be moved relative to one another or that the two clamping jaws can be moved away from one another and/or brought closer to one another by moving the head parts relative to one another.
Huettenbrink teaches an ossicular prosthesis wherein the head element has several head parts configured to be moved relative to one another (Fig. 1b, first fastening element 11 is formed as a head plate which comprises multiple bridging elements 15 that are designed to follow medial movement of the tympanic membrane [0051-0052]). Huettenbrink discloses that the movement angles of the bridging elements are selected to mimic the anatomical shape of the tympanic membrane [0054]. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the head element taught by Steinhardt with the head parts taught by Huettenbrink in order to better replicate the inner ear anatomy for device integration.
Lenarz teaches a device for connecting to parts of the inner ear that the two clamping jaws can be moved away from one another and/or brought closer to one another by moving the head parts relative to one another (Fig. 1a, connecting piece has two horns that protrude laterally outward away from shaft axis to improve maneuverability of the first coupling element during implantation [0020]). Lenarz discloses that the horns increase the inherent stability of the connecting element [0020]. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the clamping jaws taught by Steinhardt with the head parts taught by Huettenbrink and the movement abilities taught by Lenarz in order to provide a more stable connection between the jaws and the stapes of the ear.
Regarding claim 2, Steinhardt fails to teach the limitations of claim 2. However, Kroll teaches an inner ear fixation device wherein the clamping jaws are configured to be moved apart by moving the head parts apart from one another and/or by moving the head parts closer together, or the clamping jaws are configured to be moved closer together by moving the head parts closer together and/or by moving the head parts apart from one another (Fig. 1, adjustment portions 26 can be pressed towards one another to leverage engagement elements 20, 22 away from one another [0043]). Kroll discloses that the fixation device is able to be positively coupled to the ossicle without using an adhesive that could degrade over time [0039-0042]. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the auditory ossicle prosthesis taught by Steinhardt with the head element and its movements as taught by Kroll in order to better secure the implant to the ossicle without additional attachment means.
Regarding claim 3, Steinhardt fails to teach the limitations of claim 3. Kroll teaches an inner ear fixation device further comprising a deformable bar configured to connect the clamping jaws at an adjustable distance (Fig. 1, resilient portion 28 sets contact pressure of engagement elements 20, 22 [0043]). Kroll discloses that the fixation device is able to be positively coupled to the ossicle without using an adhesive that could degrade over time [0039-0042]. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the auditory ossicle prosthesis taught by Steinhardt with the head element and its movements as taught by Kroll in order to better secure the implant to the ossicle without additional attachment means.
Regarding claim 4, Steinhardt fails to teach the limitations of claim 4. However, Kroll teaches an inner ear fixation device wherein the auditory ossicle prosthesis is designed in the manner of resilient pliers, with the head parts forming pliers handles or parts of pliers handles which, when moving away from one another or approaching the clamping jaws move towards or away from one another (Fig. 1, adjustment portions 26 can be pressed towards one another to leverage engagement elements 20, 22 away from one another [0043]) and/or that the clamping jaws spring back elastically into an initial position (Fig. 1, device is formed of resilient portions (abstract) which utilize spring-clamping methods [0043] (i.e., portions recover from elastic deformation)). Kroll discloses that the fixation device is able to be positively coupled to the ossicle without using an adhesive that could degrade over time [0039-0042]. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the auditory ossicle prosthesis taught by Steinhardt with the head element and its movements as taught by Kroll in order to better secure the implant to the ossicle without additional attachment means.
Regarding claim 5, Steinhardt fails to teach the limitations of claim 5. Kroll teaches an inner ear fixation device wherein a distance between the clamping jaws is configured to be adjusted by plastic deformation and/or that the clamp is elastically deformable (Fig. 1, device is constructed from a continuous strip of nitinol and is adjustable [0043]), so that a distance between the clamping jaws can be an elastic deformation of the clamp can be changed (Fig. 1, adjustment portions 26 can be pressed towards one another to leverage engagement elements 20, 22 away from one another [0043]). Kroll discloses that the fixation device is able to be positively coupled to the ossicle without using an adhesive that could degrade over time [0039-0042]. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the auditory ossicle prosthesis taught by Steinhardt with the head element and its movements as taught by Kroll in order to better secure the implant to the ossicle without additional attachment means.
Regarding claim 6, Steinhardt teaches wherein the clamp is U-shaped, the legs of the "U" forming the clamping jaws (Fig. 3E, engagement legs 303 form u-shape).
Regarding claim 7, Steinhardt teaches wherein the auditory ossicle prosthesis (Fig. 3E, MEP 300) has two or more congruent clamps configured to be clamped onto the auditory ossicle (Fig. 3E, MEP 300 comprises two engagement legs 303 which engage with stapes 204).
Regarding claim 8, Steinhardt teaches wherein mutually facing inner surfaces or inner edges of the clamping jaws have a corrugation, spikes or teeth (Fig. 3D, engagement legs 303 comprise zig-zag shape [0024] (i.e., teeth)) each with at least one valley (Fig. 3D, lower apex of a zig-zag point on engagement legs 303) and at least one peak (Fig. 3D, higher apex of zig-zag point on engagement legs 303).
Regarding claim 9, Steinhardt teaches wherein a distance (Modified Fig. 4A below, distances D1-3) between opposite valleys (Fig. 3D, lower apex of a zig-zag point on engagement legs 303) increases from a free end of the clamping jaws to a closed end of the clamp (Modified Fig. 4A below, distances D1-3 increase in width from the free end (nearest D1) of engagement legs 303 to closed end (nearest D3)).
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Modified Figure 4A
Regarding claim 10, Steinhardt teaches wherein the products formed from the distances between opposite valleys and the respective distance of these valleys from a pivot point specified by the bar are the same at the closed end (Modified Fig. 3D, distance D3 and height H3 from central portion 302 are equivalent (they form a square)).
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Modified Figure 3D
Regarding claim 11, Steinhardt teaches wherein in an initial position of the auditory ossicle prosthesis (Fig. 3E, MEP 300), a distance between opposite peaks increases from a free end to a closed end of the clamp (Modified Fig. 3E below, widths W1-3 increase from a free end (nearest W1) to a closed end (nearest W3)).
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Modified Figure 3E
Regarding claim 12, Steinhardt teaches wherein in a coupling position of the auditory ossicle prosthesis (Fig. 4A) a distance between opposing peaks (Modified Fig. 3E above, widths W1-3) decreases from a free end to a closed end (Fig. 3E, engagement legs 303 may have an opening that is either smaller or larger than the stapes 204 [0025] (i.e., legs are angled to comprise decreasing distances between peaks from free to closed end)).
Regarding claim 13, Steinhardt teaches wherein the auditory ossicle prosthesis is in one piece (Fig. 3E, MEP 300 is one piece).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GABRIELLA GISELLE B RIOS whose telephone number is (703)756-5958. The examiner can normally be reached M-Th 7:30-6:00 EST.
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/G.G.R./Examiner, Art Unit 3774
/THOMAS C BARRETT/SPE, Art Unit 3799
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