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 Status
Applicant’s Remarks and Amendments filed 17 February 2026 have been entered. Claims 1-9 are pending.
Response to Arguments
Applicant’s arguments with respect to claims 1, 3, and 6-8 have been considered but are moot because the new ground of rejection does not rely on any combination of references applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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 1-4, 6, and 8-9 are rejected under 35 U.S.C. 103 as being unpatentable over Steinhardt et al. (US 2008/0195201 A1), “Steinhardt” in view of Steinhardt et al. (US 2009/0240332), “Steinhardt 332”, and Kurz (DE 202017104195 U1), “Kurz”, and further in view of Steinhardt et al. (US 2009/0240330 A1), “Steinhardt 330”.
Regarding claim 1, Steinhardt teaches a length-adjustable ossicular prosthesis (Fig. 2, ossicle prosthesis 20), comprising a head element (Fig. 2, first securing element 11), which is intended to be disposed at an eardrum (Fig. 2, first securing element 11 is formed as a head plate for contact with the eardrum [0036]), a foot element (Fig. 2, second securing element 22), which is intended to be disposed at an ossicle or oval window of the human middle ear (Fig. 2, second securing element 22 mechanically connects to a member of the ossicle chain or inner ear [0001]), and a connecting element (Fig. 2, elongated shaft 16), which connects the head element and the foot element (Fig. 2, elongated shaft 16 engages with first and second securing elements 11, 22), but fails to teach an open and closable ring, guiding and clamping elements, and tensioning elements.
Steinhardt 332 teaches an auditory ossicle prosthesis wherein the head element comprises: a clip comprising an open and closable ring, (Fig. 1b, interruptions 18 (i.e., openings) in the outer ring areas 16 are able to be pressed together (i.e., closed) under plastic deformation [0028]). Steinhardt 332 discloses that the oval or circular shape of the first securing element of the implant is easy to produce [0028]. 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 opening and closing flexibility of the head element taught by Steinhardt 332 with the head element taught by Steinhardt in order to provide an implant that is cheap to produce. However, Steinhardt in view of Steinhardt 332 fails to teach guiding and clamping elements or tensioning elements.
Kurz teaches an ossicular prosthesis comprising guiding and clamping elements (Fig. 1, first and second short lever sections 12.1’, 12.2’), which project inwardly from the ring (Fig. 1, lever sections 12.1', 12.2' extend inwardly from annular region 11); wherein when the ring is open, the guiding and clamping elements displaceably guide the head element at the connecting element in a longitudinal direction of the connecting element (Fig. 1, through hole 14 at central ends of lever sections 12.1', 12.2' allows for lateral insertion of shaft-shaped end of the connecting element and hole 14 is narrowed after insertion to fix connecting element in the hole 14), and the guiding and clamping elements are moved toward one another and are pressed against the connecting element when the ring is closed and securely, non-displaceably and non-rotatably clamp the head element on the connecting element (Fig. 1, first and second short lever sections 12.1', 12.2' comprise hole 14 at their center which is narrowed after insertion to fix connecting element in the hole 14); wherein arc-shaped sections of the ring form tensioning elements (Fig. 1, upper and lower sides of annular region 11 further comprising first and second long lever sections 12.1, 12.2), which, when the ring is closed, move the guiding and clamping elements toward one another and tension the guiding and clamping elements against the connecting element so as to securely, non-displaceably and non-rotatably clamp the head element on the connecting element (Fig. 1, upper and lower sides of annular region 11 further comprising first and second long lever sections 12.1, 12.2). Kurz discloses that the one piece design of the implant reduces assembly effort and production costs [0017]. 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 length-adjustable ossicular prosthesis taught by Steinhardt with the tensioning elements taught by Kurz in order to decrease the costs of production. However, Steinhardt in view of Steinhardt 332 and Kurz fails to teach a locking mechanism.
Steinhardt 330 teaches an auditory ossicle prosthesis which comprises a locking mechanism that, when closed, holds the tensioning elements in a tensioned position (Fig. 7b, barbs 77 snap-fit and secure web elements 75’ with web elements 75’’ [0086]). Steinhardt 330 discloses that the prosthesis can be reconfigured easily and flexibly in a targeted manner that meets the needs of a specific patient [0018]. 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 locking mechanism taught by Steinhardt 330 in order to create a more adaptable device.
Regarding claim 2, Steinhardt teaches wherein the guiding and clamping elements (Fig. 2, gap between struts 13, 13’ allows for adjusting the desired shaft 16 length [0037]) comprise mutually facing depressions serving as guides and clamping sections in which the connecting element is accommodated (Fig. 2, struts 13, 13’ comprise recesses 15, 15’).
Regarding claim 3, Steinhardt teaches a length-adjustable ossicular prosthesis (Fig. 2, ossicle prosthesis 20), comprising a head element (Fig. 2, first securing element 11), which is intended to be disposed at an eardrum (Fig. 2, first securing element 11 is formed as a head plate for contact with the eardrum [0036]), a foot element (Fig. 2, second securing element 22), which is intended to be disposed at an ossicle or oval window of the human middle ear (Fig. 2, second securing element 22 mechanically connects to a member of the ossicle chain or inner ear [0001]), and a connecting element (Fig. 2, elongated shaft 16), which connects the head element and the foot element (Fig. 2, elongated shaft 16 engages with first and second securing elements 11, 22), but fails to teach an open and closable ring, guiding and clamping elements, and tensioning elements.
Steinhardt 332 teaches an auditory ossicle prosthesis wherein the head element comprises: a clip comprising an open and closable ring, (Fig. 1b, interruptions 18 (i.e., openings) in the outer ring areas 16 are able to be pressed together (i.e., closed) under plastic deformation [0028]), and wherein the head element comprises a ring that is open at a point of the circumference (Fig. 1b, interruptions 18 (i.e., openings) in the outer ring area 16). Steinhardt 332 discloses that the oval or circular shape of the first securing element of the implant is easy to produce [0028]. 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 opening and closing flexibility of the head element taught by Steinhardt 332 with the head element taught by Steinhardt in order to provide an implant that is cheap to produce. However, Steinhardt in view of Steinhardt 332 fails to teach guiding and clamping elements or tensioning elements.
Kurz teaches an ossicular prosthesis comprising guiding and clamping elements (Fig. 1, first and second short lever sections 12.1’, 12.2’), which project inwardly from the ring (Fig. 1, lever sections 12.1', 12.2' extend inwardly from annular region 11); wherein when the ring is open, the guiding and clamping elements displaceably guide the head element at the connecting element in a longitudinal direction of the connecting element (Fig. 1, through hole 14 at central ends of lever sections 12.1', 12.2' allows for lateral insertion of shaft-shaped end of the connecting element and hole 14 is narrowed after insertion to fix connecting element in the hole 14), and the guiding and clamping elements are moved toward one another and are pressed against the connecting element when the ring is closed and securely, non-displaceably and non-rotatably clamp the head element on the connecting element (Fig. 1, first and second short lever sections 12.1', 12.2' comprise hole 14 at their center which is narrowed after insertion to fix connecting element in the hole 14); wherein arc-shaped sections of the ring form tensioning elements (Fig. 1, upper and lower sides of annular region 11 further comprising first and second long lever sections 12.1, 12.2), which, when the ring is closed, move the guiding and clamping elements toward one another and tension the guiding and clamping elements against the connecting element so as to securely, non-displaceably and non-rotatably clamp the head element on the connecting element (Fig. 1, upper and lower sides of annular region 11 further comprising first and second long lever sections 12.1, 12.2), and the guiding and clamping elements project inwardly so that these are tensioned against the connecting element when the ring is pressed together (Fig. 1, first and second short lever sections 12.1', 12.2' comprise hole 14 at their center which is narrowed after insertion to fix connecting element in the hole 14), and in which the ring tensions the guiding and clamping elements against the connecting element (Fig. 1, first and second short lever sections 12.1', 12.2' comprise hole 14 at their center which is narrowed after insertion to fix connecting element in the hole 14 after subjection to forces). Kurz discloses that the one piece design of the implant reduces assembly effort and production costs [0017]. 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 length-adjustable ossicular prosthesis taught by Steinhardt with the tensioning elements taught by Kurz in order to decrease the costs of production. However, Steinhardt in view of Steinhardt 332 and Kurz fails to teach a locking mechanism.
Steinhardt 330 teaches an auditory ossicle prosthesis which comprises a locking mechanism that, when closed, holds the tensioning elements in a tensioned position (Fig. 7b, barbs 77 snap-fit and secure web elements 75’ with web elements 75’’ [0086]), and that the ring can be closed by way of the locking mechanism in the tensioned position (Fig. 7b, barbs 77 secure auditory ossicle prosthesis 70 jigsaw pieces 76, 76’ together [0086]). Steinhardt 330 discloses that the prosthesis can be reconfigured easily and flexibly in a targeted manner that meets the needs of a specific patient [0018]. 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 locking mechanism taught by Steinhardt 330 in order to create a more adaptable device.
Regarding claim 4, Steinhardt in view of Kurz fails to teach the limitations of claim 4. Steinhardt 330 teaches an auditory ossicle prosthesis wherein the locking mechanism (Fig. 7b, barbs 77) comprises a hook on one side of an opening of the ring (Fig. 7c, barbs 77 comprise a hook), which can engage with a mating piece on another side of the opening of the ring (Fig. 7b, barbs 77 snap-fit and secure web elements 75’ with web elements 75’’ [0086]). Steinhardt 330 discloses that the prosthesis can be reconfigured easily and flexibly in a targeted manner that meets the needs of a specific patient [0018]. 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 prosthesis taught by Steinhardt with the locking elements taught by Steinhardt 330 in order to create an adaptable, patient-specific device.
Regarding claim 6, Steinhardt teaches a length-adjustable ossicular prosthesis (Fig. 2, ossicle prosthesis 20), comprising a head element (Fig. 2, first securing element 11), which is intended to be disposed at an eardrum (Fig. 2, first securing element 11 is formed as a head plate for contact with the eardrum [0036]), a foot element (Fig. 2, second securing element 22), which is intended to be disposed at an ossicle or oval window of the human middle ear (Fig. 2, second securing element 22 mechanically connects to a member of the ossicle chain or inner ear [0001]), and a connecting element (Fig. 2, elongated shaft 16), which connects the head element and the foot element (Fig. 2, elongated shaft 16 engages with first and second securing elements 11, 22), but fails to teach an open and closable ring, guiding and clamping elements, and tensioning elements.
Steinhardt 332 teaches an auditory ossicle prosthesis wherein the head element comprises: a clip comprising an open and closable ring, (Fig. 1b, interruptions 18 (i.e., openings) in the outer ring areas 16 are able to be pressed together (i.e., closed) under plastic deformation [0028]), wherein the head element comprises a ring that is open at a point of the circumference (Fig. 1b, interruptions 18 (i.e., openings) in the outer ring area 16). Steinhardt 332 discloses that the oval or circular shape of the first securing element of the implant is easy to produce [0028]. 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 opening and closing flexibility of the head element taught by Steinhardt 332 with the head element taught by Steinhardt in order to provide an implant that is cheap to produce. However, Steinhardt in view of Steinhardt 332 fails to teach guiding and clamping elements or tensioning elements.
Kurz teaches an ossicular prosthesis comprising guiding and clamping elements (Fig. 1, first and second short lever sections 12.1’, 12.2’), which project inwardly from the ring (Fig. 1, lever sections 12.1', 12.2' extend inwardly from annular region 11); wherein when the ring is open, the guiding and clamping elements displaceably guide the head element at the connecting element in a longitudinal direction of the connecting element (Fig. 1, through hole 14 at central ends of lever sections 12.1', 12.2' allows for lateral insertion of shaft-shaped end of the connecting element and hole 14 is narrowed after insertion to fix connecting element in the hole 14), and the guiding and clamping elements are moved toward one another and are pressed against the connecting element when the ring is closed and securely, non-displaceably and non-rotatably clamp the head element on the connecting element (Fig. 1, first and second short lever sections 12.1', 12.2' comprise hole 14 at their center which is narrowed after insertion to fix connecting element in the hole 14); wherein arc-shaped sections of the ring form tensioning elements (Fig. 1, upper and lower sides of annular region 11 further comprising first and second long lever sections 12.1, 12.2), which, when the ring is closed, move the guiding and clamping elements toward one another and tension the guiding and clamping elements against the connecting element so as to securely, non-displaceably and non-rotatably clamp the head element on the connecting element (Fig. 1, upper and lower sides of annular region 11 further comprising first and second long lever sections 12.1, 12.2), and the guiding and clamping elements project inwardly so that these are tensioned against the connecting element when the ring is pressed together (Fig. 1, first and second short lever sections 12.1', 12.2' comprise hole 14 at their center which is narrowed after insertion to fix connecting element in the hole 14), in which the ring tensions the guiding and clamping elements against the connecting element (Fig. 1, first and second short lever sections 12.1', 12.2' comprise hole 14 at their center which is narrowed after insertion to fix connecting element in the hole 14 after subjection to forces). Kurz discloses that the one piece design of the implant reduces assembly effort and production costs [0017]. 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 length-adjustable ossicular prosthesis taught by Steinhardt with the tensioning elements taught by Kurz in order to decrease the costs of production. However, Steinhardt in view of Steinhardt 332 and Kurz fails to teach a locking mechanism.
Steinhardt 330 teaches an auditory ossicle prosthesis which comprises a locking mechanism that, when closed, holds the tensioning elements in a tensioned position (Fig. 7b, barbs 77 snap-fit and secure web elements 75’ with web elements 75’’ [0086]), and that the ring can be closed by way of the locking mechanism in the tensioned position (Fig. 7b, barbs 77 secure auditory ossicle prosthesis 70 jigsaw pieces 76, 76’ together [0086]), and wherein the ring has a reduced cross-sectional area at a point of the circumference (Fig. 7b, radially outer portion 76 is thinner than other portions of first securing element 71). Steinhardt 330 discloses that the prosthesis can be reconfigured easily and flexibly in a targeted manner that meets the needs of a specific patient [0018]. 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 locking mechanism taught by Steinhardt 330 in order to create a more adaptable device.
Regarding claim 8, Steinhardt teaches a length-adjustable ossicular prosthesis (Fig. 2, ossicle prosthesis 20), comprising a head element (Fig. 2, first securing element 11), which is intended to be disposed at an eardrum (Fig. 2, first securing element 11 is formed as a head plate for contact with the eardrum [0036]), a foot element (Fig. 2, second securing element 22), which is intended to be disposed at an ossicle or oval window of the human middle ear (Fig. 2, second securing element 22 mechanically connects to a member of the ossicle chain or inner ear [0001]), and a connecting element (Fig. 2, elongated shaft 16), which connects the head element and the foot element (Fig. 2, elongated shaft 16 engages with first and second securing elements 11, 22), but fails to teach an open and closable ring, guiding and clamping elements, and tensioning elements.
Steinhardt 332 teaches an auditory ossicle prosthesis wherein the head element comprises: a clip comprising an open and closable ring, (Fig. 1b, interruptions 18 (i.e., openings) in the outer ring areas 16 are able to be pressed together (i.e., closed) under plastic deformation [0028]), wherein the head element comprises a ring that is open at a point of the circumference (Fig. 1b, interruptions 18 (i.e., openings) in the outer ring area 16). Steinhardt 332 discloses that the oval or circular shape of the first securing element of the implant is easy to produce [0028]. 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 opening and closing flexibility of the head element taught by Steinhardt 332 with the head element taught by Steinhardt in order to provide an implant that is cheap to produce. However, Steinhardt in view of Steinhardt 332 fails to teach guiding and clamping elements or tensioning elements.
Kurz teaches an ossicular prosthesis comprising guiding and clamping elements (Fig. 1, first and second short lever sections 12.1’, 12.2’), which project inwardly from the ring (Fig. 1, lever sections 12.1', 12.2' extend inwardly from annular region 11); wherein when the ring is open, the guiding and clamping elements displaceably guide the head element at the connecting element in a longitudinal direction of the connecting element (Fig. 1, through hole 14 at central ends of lever sections 12.1', 12.2' allows for lateral insertion of shaft-shaped end of the connecting element and hole 14 is narrowed after insertion to fix connecting element in the hole 14), and the guiding and clamping elements are moved toward one another and are pressed against the connecting element when the ring is closed and securely, non-displaceably and non-rotatably clamp the head element on the connecting element (Fig. 1, first and second short lever sections 12.1', 12.2' comprise hole 14 at their center which is narrowed after insertion to fix connecting element in the hole 14); wherein arc-shaped sections of the ring form tensioning elements (Fig. 1, upper and lower sides of annular region 11 further comprising first and second long lever sections 12.1, 12.2), which, when the ring is closed, move the guiding and clamping elements toward one another and tension the guiding and clamping elements against the connecting element so as to securely, non-displaceably and non-rotatably clamp the head element on the connecting element (Fig. 1, upper and lower sides of annular region 11 further comprising first and second long lever sections 12.1, 12.2), from which the guiding and clamping elements project inwardly so that these are tensioned against the connecting element when the ring is pressed together (Fig. 1, first and second short lever sections 12.1', 12.2' comprise hole 14 at their center which is narrowed after insertion to fix connecting element in the hole 14), and in which the ring tensions the guiding and clamping elements against the connecting element (Fig. 1, first and second short lever sections 12.1', 12.2' comprise hole 14 at their center which is narrowed after insertion to fix connecting element in the hole 14 after subjection to forces). Kurz discloses that the one piece design of the implant reduces assembly effort and production costs [0017]. 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 length-adjustable ossicular prosthesis taught by Steinhardt with the tensioning elements taught by Kurz in order to decrease the costs of production. However, Steinhardt in view of Steinhardt 332 and Kurz fails to teach a locking mechanism.
Steinhardt 330 teaches an auditory ossicle prosthesis which comprises a locking mechanism that, when closed, holds the tensioning elements in a tensioned position (Fig. 7b, barbs 77 snap-fit and secure web elements 75’ with web elements 75’’ [0086]), and that the ring can be closed by way of the locking mechanism in the tensioned position (Fig. 7b, barbs 77 secure auditory ossicle prosthesis 70 jigsaw pieces 76, 76’ together [0086]), and wherein the guiding and clamping elements (Fig. 3b, radially inner coupling area 34) are disposed at a greater distance with respect to the opening of the ring than with respect to a point of the circumference which is located opposite the opening (Fig. 3b, radially inner coupling area 34 is closer to a point opposite the ring opening (i.e., web element 35’’’) than the ring opening itself), such that, upon closing of the ring, a clamping force exerted by the guiding and clamping elements onto the connecting element is maximized at a circumferential region opposite the opening of the ring (functional limitations are met if the prior art teaches the features of the claimed device). Steinhardt 330 discloses that the prosthesis can be reconfigured easily and flexibly in a targeted manner that meets the needs of a specific patient [0018]. 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 locking mechanism taught by Steinhardt 330 in order to create a more adaptable device.
Regarding claim 9, Steinhardt teaches wherein the foot element (Fig. 2, second securing element 22) is designed to be provided at a stirrup or the oval window of the middle ear of a person (Fig. 2, second securing element 22 mechanically connects to a member of the ossicle chain or inner ear [0001]).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Steinhardt et al. (US 2008/0195201 A1), “Steinhardt” in view of Steinhardt et al. (US 2009/0240332), “Steinhardt 332”, Kurz (DE 202017104195 U1), “Kurz” and Steinhardt et al. (US 2009/0240330 A1), “Steinhardt 330” and further in view of Ball et al. (US 2011, 0178364 A1), “Ball”.
Regarding claim 5, Steinhardt teaches and that a circumference of the ring and/or a distance of the guiding and clamping elements with respect to one another can be adjusted for adaptation to connecting elements having differing diameters (Fig. 2, the gaplike space between struts 13, 13’ can be made narrower for fixation of the shaft 16 [0007]), but Steinhardt in view of Kurz fails to teach the locking mechanism, wherein each of the individual hooks being engageable with the mating piece on the other side of the opening of the ring, or that two or more hooks behind one another along the ring on one side of an opening.
Steinhardt 330 teaches an auditory ossicle prosthesis the locking mechanism (Fig. 7b, barbs 77), wherein each of the individual hooks being engageable with the mating piece on the other side of the opening of the ring (Fig. 7b, barbs 77 snap-fit and secure web elements 75’ with web elements 75’’ [0086]). However, Steinhardt in view of Kurz and Steinahrdt 330 fails to teach two or more hooks behind one another along the ring on one side of an opening.
Ball teaches a partial ossicular replacement prosthesis comprising two or more hooks behind one another (Fig. 2A, clamp strap 205 comprises protrusions) along the ring on one side of an opening (Fig. 2A, protrusions on clamp strap 205 are only one side), However, and that a circumference of the ring and/or a distance of the guiding and clamping elements with respect to one another can be adjusted for adaptation to connecting elements having differing diameters.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Steinhardt et al. (US 2008/0195201 A1), “Steinhardt” in view of Steinhardt et al. (US 2009/0240332), “Steinhardt 332”, Kurz (DE 202017104195 U1), “Kurz” and Steinhardt et al. (US 2009/0240330 A1), “Steinhardt 330” and further in view of Scheurer et al. (US 20150045883 A1), “Scheurer”.
Regarding claim 7, Steinhardt teaches a length-adjustable ossicular prosthesis (Fig. 2, ossicle prosthesis 20), comprising a head element (Fig. 2, first securing element 11), which is intended to be disposed at an eardrum (Fig. 2, first securing element 11 is formed as a head plate for contact with the eardrum [0036]), a foot element (Fig. 2, second securing element 22), which is intended to be disposed at an ossicle or oval window of the human middle ear (Fig. 2, second securing element 22 mechanically connects to a member of the ossicle chain or inner ear [0001]), and a connecting element (Fig. 2, elongated shaft 16), which connects the head element and the foot element (Fig. 2, elongated shaft 16 engages with first and second securing elements 11, 22), but fails to teach an open and closable ring, guiding and clamping elements, and tensioning elements.
Steinhardt 332 teaches an auditory ossicle prosthesis wherein the head element comprises: a clip comprising an open and closable ring, (Fig. 1b, interruptions 18 (i.e., openings) in the outer ring area 16 are able to be pressed together (i.e., closed) under plastic deformation [0028]), wherein the head element comprises a ring that is open at a point of the circumference (Fig. 1b, interruptions 18 (i.e., openings) in the outer ring area 16). Steinhardt 332 discloses that the oval or circular shape of the first securing element of the implant is easy to produce [0028]. 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 opening and closing abilities of the head element taught by Steinhardt 332 with the head element taught by Steinhardt in order to provide an implant that is cheap to produce. However, Steinhardt in view of Steinhardt 332 fails to teach guiding and clamping elements or tensioning elements.
Kurz teaches an ossicular prosthesis comprising guiding and clamping elements (Fig. 1, first and second short lever sections 12.1’, 12.2’), which project inwardly from the ring (Fig. 1, lever sections 12.1', 12.2' extend inwardly from annular region 11); wherein when the ring is open, the guiding and clamping elements displaceably guide the head element at the connecting element in a longitudinal direction of the connecting element (Fig. 1, through hole 14 at central ends of lever sections 12.1', 12.2' allows for lateral insertion of shaft-shaped end of the connecting element and hole 14 is narrowed after insertion to fix connecting element in the hole 14), and the guiding and clamping elements are moved toward one another and are pressed against the connecting element when the ring is closed and securely, non-displaceably and non-rotatably clamp the head element on the connecting element (Fig. 1, first and second short lever sections 12.1', 12.2' comprise hole 14 at their center which is narrowed after insertion to fix connecting element in the hole 14); wherein arc-shaped sections of the ring form tensioning elements (Fig. 1, upper and lower sides of annular region 11 further comprising first and second long lever sections 12.1, 12.2), which, when the ring is closed, move the guiding and clamping elements toward one another and tension the guiding and clamping elements against the connecting element so as to securely, non-displaceably and non-rotatably clamp the head element on the connecting element (Fig. 1, upper and lower sides of annular region 11 further comprising first and second long lever sections 12.1, 12.2), the guiding and clamping elements project inwardly so that these are tensioned against the connecting element when the ring is pressed together (Fig. 1, first and second short lever sections 12.1', 12.2' comprise hole 14 at their center which is narrowed after insertion to fix connecting element in the hole 14), the ring tensions the guiding and clamping elements against the connecting element (Fig. 1, first and second short lever sections 12.1', 12.2' comprise hole 14 at their center which is narrowed after insertion to fix connecting element in the hole 14 after subjection to forces), in which the tensioning elements tension the guiding and clamping elements against the connecting element (Fig. 1, first and second short lever sections 12.1', 12.2' comprise hole 14 at their center which is narrowed after insertion to fix connecting element in the hole 14 after subjection to forces), and wherein the ring, on both sides of the opening, comprises application surfaces on the outer side thereof (Fig. 1, outer sides of annular region 11 subjected to force F1). Kurz discloses that the one piece design of the implant reduces assembly effort and production costs [0017]. 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 length-adjustable ossicular prosthesis taught by Steinhardt with the tensioning elements taught by Kurz in order to decrease the costs of production. However, Steinhardt in view of Steinhardt 332 and Kurz fails to teach a locking mechanism.
Steinhardt 330 teaches an auditory ossicle prosthesis which comprises a locking mechanism that, when closed, holds the tensioning elements in a tensioned position (Fig. 7b, barbs 77 snap-fit and secure web elements 75’ with web elements 75’’ [0086]), and that the ring can be closed by way of the locking mechanism in the tensioned position (Fig. 7b, barbs 77 secure auditory ossicle prosthesis 70 jigsaw pieces 76, 76’ together [0086]), wherein the locking mechanism comprises a hook on one side of an opening of the ring, which can engage with a mating piece on another side of the opening of the ring (Fig. 7b, barbs 77 snap-fit and secure web elements 75’ with web elements 75’’ [0086]). Steinhardt 330 discloses that the prosthesis can be reconfigured easily and flexibly in a targeted manner that meets the needs of a specific patient [0018]. 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 tensioning elements taught by Kurz with the locking mechanism taught by Steinhardt 330 in order to create a more adaptable device.
Scheurer teaches a middle ear prosthesis comprising a closing tool for closing the ring (Fig. 10 shows an engaging instrument, forceps), which are shaped so that the applied closing tool does not slip in the circumferential direction of the ring when exerting a closing force on the ring (Figs. 8-10, forceps form-fit a prosthesis for implantation [0045]). Scheurer discloses that the forceps can be configured differently so that the surgeon may fit them into tighter implantation spaces [0046]. 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 prosthesis taught by Steinhardt in view of Kurz and Steinhardt 330 with the closing tool taught by Scheuer in order to ease the implantation process in tight fitting locations.
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.
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/G.G.R./ Examiner, Art Unit 3774
/THOMAS C BARRETT/ SPE, Art Unit 3799
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