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 .
Priority
The priority date is 28 August 2023.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the “the guide device comprises a constriction that forms the stop” (claim 11) must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required: The specification does not provide proper antecedent basis for transmitting the guide device to the fastening device (claim 8). Rather, the specification recites transmitting the impact energy to the fastening device.
Claim Objections
Claims 13, 16, 17, and 22 are objected to because of the following informalities: improper antecedence and language. Appropriate correction is required. The following amendments are suggested:
Claim 13 / lines 2-3: “in which the impact device is arranged to allow movement of the impact device with respect to the housing”
Claim 16 / line 3: “guided by the at least [[a]] the part of the wall”
Claim 17 / lines 2-3: “the translational direction of movement
Claim 22 / lines 2-3: “or counter to substantially the translational direction of movement,”
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 4-16 and 20 are rejected under 35 U.S.C. 112(b) 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.
As to claim 4, the limitation “in a manner that is substantially movable in the translational direction of movement” renders the claim indefinite, because it is unclear as to the scope of the claim, particularly the phrase “a manner that is substantially movable”. For examination purposes, the limitation will be interpreted as deleted.
As to claim 5, the limitation “a fastening device” renders the claims indefinite, because it is unclear if this refers to the previous recitation of a fastening device (claim 1 / line 4), or to a different fastening device. For examination purposes, the limitation will be interpreted in the former instance, as the fastening device.
As to claim 11, the limitation “the guide device comprises a constriction that forms the stop” renders the claim indefinite, because it is unclear how the guide device comprises a constriction that forms the stop, where the stop is also a projection of the housing as recited in claim 10. For examination purposes, the limitation in claim 11 will be interpreted as deleted.
As to claim 16, the limitation “wherein the guide comprises at least a part of a wall of the housing” renders the claim indefinite, because it is unclear how the guide can comprise a part of a wall of the housing when the guide and the housing are separate parts. For examination purposes, the claim will be interpreted as at least a part of a wall of the housing is designed to allow a movement.
As to claim 20, the limitation “wherein at least one notch is arranged in the region, the at least one notch being configured as the handle” renders the claim indefinite, because it is unclear how the notch can be in the region and configured as the handle, when the region is separated from the area that forms the handle by the raised portion. For examination purposes, the limitation will be interpreted as “wherein at least one notch is arranged in the area, the at least one notch being configured as the handle.”
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-5, 7-10, 12-14, and 16-22 are rejected under 35 U.S.C. 102(a)(1)/(2) as anticipated by U.S. Patent No. US 5,282,866 to Cohen et al. (hereinafter, “Cohen”).
As to claim 1, Cohen discloses an apparatus for preparing a medullary cavity of a bone for an implant, the apparatus comprising: a drill (not shown) for producing a bore in the medullary cavity (col. 5 / lines 49-52); a fastening device (152) for a rasp (138) for producing an opening in the medullary cavity (col. 6 / lines 8-12); a housing (110 and 96); and a guide (104 and 144 and 150), the drill and the fastening device each being translationally movable relative to the housing (the drill is translationally movable relative to 96 and the fastening device is translationally movable relative to 110 and 96), the guide (at 104) configured to guide the drill in a translational direction of movement for producing the bore, and the guide (at 144) configured to guide the rasp in the translational direction of movement or in substantially the translational direction of movement for producing the opening (since moving the guide at 144 would move the rasp 138, FIGS. 12 and 14, which occurs in the translational direction of movement when the fastening device is in the housing at 110).
As to claim 2, Cohen discloses the apparatus according to claim 1, wherein the drill and the rasp are translationally movable relative to one another in the translational direction of movement or in substantially the translational direction of movement (the drill and the rasp are translationally movable relative to one another because they are used separately; when the drill is being translated in the translational direction of movement, the rasp is stationary, and vice versa).
As to claim 3, Cohen discloses the apparatus according to claim 1, wherein the guide comprises a guide device (104 and 144 and 150) that is at least partially arranged in the housing (guide device at 104 is received within aperture 106 in the housing at 96) and designed to allow a movement of the drill in the translational direction of movement guided by the guide device (the drill is advanced through the guide device at 104 in the translational direction of movement, col. 5 / lines 49-52).
As to claim 4, Cohen discloses the apparatus according to claim 3, wherein the guide device is translationally movable relative to the housing in the translational direction of movement or in a manner that is substantially movable in the translational direction of movement (the guide device at 104 is translationally movable into the aperture 106 in the housing at 96, and the guide device at 150 is translationally movable relative to the housing at 110, FIG. 14).
As to claim 5, Cohen discloses the apparatus according to claim 3, further comprising a fastening device (152) for the rasp, wherein the rasp is attached to the fastening device, FIG. 8.
As to claim 7, Cohen discloses the apparatus according to claim 5, wherein the guide device comprises the fastening device (since 152 is an extension of 150 of the guide device).
As to claim 8, Cohen discloses the apparatus according to claim 5, wherein the guide device is designed to absorb impact energy (at 144) for movement of the guide device (at 144 and 150) in the translational direction of movement and to transmit the guide device to the fastening device (since the fastening device 152 is an extension of 144/150) for movement of the fastening device in the translational direction of movement or in substantially the translational direction of movement, FIG. 14.
As to claim 9, Cohen discloses the apparatus according to claim 8, wherein the guide device is arranged at least partially in the housing (the guide device at 150 is arranged at least partially in the housing at 110, FIG. 14), and wherein the housing has a projection (protruding top surface of 110) that is configured as a stop for the guide device (at 144, FIG. 14).
As to claim 10, Cohen discloses the apparatus according to claim 8, wherein the fastening device is at least partially arranged in the housing (col. 6 / lines 23-32), and wherein the housing has a projection (protruding top surface of 110) that is designed as a stop for the fastening device (an interior of guideway 122 in the projection is a stop for the fastening device, stopping further lateral movement of the fastening device).
As to claim 12, Cohen discloses the apparatus according to claim 8, wherein the guide device comprises an impact device (144 and 150) for absorbing the impact energy.
As to claim 13, Cohen discloses the apparatus according to claim 12, wherein the housing comprises a recess (122) for the impact device, FIG. 14, in which the impact device is arranged in a manner allowing movement with respect to the housing in the translational direction of movement up to an end (at top surface of 110) of the recess designed as a stop, FIG. 14.
As to claim 14, Cohen discloses the apparatus according to claim 12, wherein the impact device comprises a surface (top surface of 144 which projects radially relative to the translational direction of movement) which projects (proximally) from the housing at least in sections radially to the translational direction of movement or to substantially the translational direction of movement for absorbing the impact energy, wherein the impact device comprises an undercut (indent in 144) on a rear side (below) of the surface.
As to claim 16, Cohen discloses the apparatus according to claim 1, wherein the guide comprises at least a part of a wall of the housing (the guide at 150 comprises a part of the wall of the housing where the housing at 110 is cutaway so that the guide forms that part of the exterior wall), which is designed to allow a movement of the rasp or the fastening device guided by at least a part of the wall in the translational direction of movement or in substantially the translational direction of movement, FIGS. 12 and 14.
As to claim 17, Cohen discloses the apparatus according to claim 1, wherein the apparatus comprises a stop (top of 104) acting in or counter to the translational direction of movement for translational movement of the drill relative to the housing.
As to claim 18, Cohen discloses the apparatus according to claim 1, wherein the housing comprises an outside (outside of 110) and an area (midportion of 110) on the outside that forms a handle (fully capable of being gripped or handled).
As to claim 19, Cohen discloses the apparatus according to claim 18, wherein the housing comprises a raised portion (114, raised relative to 96) on the outside, the raised portion arranged between said area on the outside and a region (region of 96, including 120) of the apparatus, in which a head of the drill or the rasp is arranged.
As to claim 20, Cohen discloses the apparatus according to claim 19, wherein at least one notch (cutaway in side of 110) is arranged in the region, the at least one notch being configured as the handle (fully capable of being gripped or handled).
As to claim 21, Cohen discloses the apparatus according to claim 1, wherein the rasp comprises at least two blades (142), FIG. 8, wherein a recess (106) for the drill is arranged between the at least two blades (the recess is between the two blades when the blades are passing through slots 120 on either side of the recess).
As to claim 22, Cohen discloses the apparatus according to claim 1, wherein the housing comprises a deflection device (protruding top portion of 110) for absorbing an impact energy counter to the translational direction of movement or counter to the translational direction of movement, wherein the deflection device has a surface protruding from the housing (surface of top portion of 110 protrudes from the cutaway portion of the housing at 110) at least in sections radially to the translational direction of movement or to substantially the translational direction of movement for absorbing the impact energy, FIGS. 8 and 14.
Claims 1-5, 7-9, 12-14, and 16-24 are rejected under 35 U.S.C. 102(a)(1)/(2) as anticipated by U.S. Patent No. US 8,728,086 to Smith et al. (hereinafter, “Smith”).
As to claim 1, Smith discloses an apparatus for preparing a medullary cavity of a bone for an implant, the apparatus comprising: a drill (284) for producing a bore in the medullary cavity (col. 45 / lines 17-21), FIG. 129; a fastening device, see annotated figure below, for a rasp (distal end of 276) for producing an opening in the medullary cavity, FIGS. 129-132; a housing (270); and a guide (proximal portion of 276), the drill and the fastening device each being translationally movable relative to the housing, the guide configured to guide the drill in a translational direction of movement for producing the bore (the guide guides the drill therethrough), FIG. 129, and the guide configured to guide the rasp in the translational direction of movement or in substantially the translational direction of movement for producing the opening (the guide guides the rasp because they are connected to each other, so movement of the guide along the housing 270 in the translational direction of movement would also guide the rasp along the direction of movement), FIG. 132.
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Smith, FIG. 129, annotated
As to claim 2, Smith discloses the apparatus according to claim 1, wherein the drill and the rasp are translationally movable relative to one another in the translational direction of movement or in substantially the translational direction of movement, FIGS. 129-132.
As to claim 3, Smith discloses the apparatus according to claim 1, wherein the guide comprises a guide device (proximal portion of 276) that is at least partially arranged in the housing, see e.g. FIG. 126 for the guide device sliding in the housing, and designed to allow a movement of the drill in the translational direction of movement guided by the guide device (the drill passes through the guide device).
As to claim 4, Smith discloses the apparatus according to claim 3, wherein the guide device is translationally movable relative to the housing in the translational direction of movement or in a manner that is substantially movable in the translational direction of movement, FIGS. 129-132.
As to claim 5, Smith discloses the apparatus according to claim 3, further comprising a fastening device, see annotated figure, for the rasp, wherein the rasp is attached to the fastening device.
As to claim 7, Smith discloses the apparatus according to claim 5, wherein the guide device comprises the fastening device (since the fastening device is an extension of the guide device).
As to claim 8, Smith discloses the apparatus according to claim 5, wherein the guide device is designed to absorb impact energy (at its proximal face) for movement of the guide device in the translational direction of movement and to transmit the guide device to the fastening device (since the fastening device is an extension of the guide device) for movement of the fastening device in the translational direction of movement or in substantially the translational direction of movement.
As to claim 9, Smith discloses the apparatus according to claim 8, wherein the guide device is arranged at least partially in the housing, see e.g. FIG. 126, and wherein the housing has a projection (proximally projecting portion of 270) that is configured as a stop for the guide device (the guide device stops further advancement when abutting the top surface/stop of the housing projection, FIG. 132).
As to claim 12, Smith discloses the apparatus according to claim 8, wherein the guide device comprises an impact device for absorbing the impact energy.
As to claim 13, Smith discloses the apparatus according to claim 12, wherein the housing comprises a recess (in side of 270) for the impact device, see e.g. FIG. 126, in which the impact device is arranged in a manner allowing movement with respect to the housing in the translational direction of movement up to an end of the recess designed as a stop (the impact device can move in the housing until a proximal end of the impact device reaches the proximal end of the recess and abuts the surface of the housing forming the recess, where the proximal surface of the housing surrounding the recess is a stop).
As to claim 14, Smith discloses the apparatus according to claim 12, wherein the impact device comprises a surface which projects (proximally) from the housing at least in sections radially to the translational direction of movement or to substantially the translational direction of movement for absorbing the impact energy, wherein the impact device comprises an undercut on a rear side of the surface, see e.g. FIG. 126 where the undercut accommodates 270.
As to claim 16, Smith discloses the apparatus according to claim 1, wherein the guide comprises at least a part of a wall of the housing (the guide comprises a part of the wall of the housing where the housing is cutaway so that the guide forms that part of the exterior wall), which is designed to allow a movement of the rasp or the fastening device guided by at least a part of the wall in the translational direction of movement or in substantially the translational direction of movement.
As to claim 17, Smith discloses the apparatus according to claim 1, wherein the apparatus comprises a stop (top surface of 276) acting in or counter to the translational direction of movement for translational movement of the drill relative to the housing.
As to claim 18, Smith discloses the apparatus according to claim 1, wherein the housing comprises an outside and an area (outer surface of 270 on the right in FIG. 129) on the outside that forms a handle (fully capable of being gripped or handled).
As to claim 19, Smith discloses the apparatus according to claim 18, wherein the housing comprises a raised portion (sides of 270 that are raised to form the recess that receives 276) on the outside, the raised portion arranged between said area on the outside and a region (to the left of 270 in FIG. 129) of the apparatus, in which a head of the drill or the rasp is arranged, FIG. 129.
As to claim 20, Smith discloses the apparatus according to claim 19, wherein at least one notch is arranged in the region, see e.g. FIG. 126, the at least one notch being configured as the handle (fully capable of being gripped or handled).
As to claim 21, Smith discloses the apparatus according to claim 1, wherein the rasp comprises at least two blades, see e.g. FIG. 124, wherein a recess for the drill is arranged between the at least two blades, FIG. 129.
As to claim 22, Smith discloses the apparatus according to claim 1, wherein the housing comprises a deflection device (128) for absorbing an impact energy (fully capable of receiving and absorbing an impact energy since it protrudes from the housing) counter to the translational direction of movement or counter to the translational direction of movement, wherein the deflection device has a surface protruding from the housing at least in sections radially, FIG. 129, to the translational direction of movement or to substantially the translational direction of movement for absorbing the impact energy.
As to claim 23, Smith discloses an instrument for preparing a medullary cavity of a bone for an implant, the instrument comprising: the apparatus according to claim 1; and at least two exchangeable drills (the two drills 284 are the same and thus exchangeable with each other) or at least two exchangeable rasps.
As to claim 24, Smith discloses the instrument according to claim 23, further comprising a preparation plateau (244).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 6, 23, and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Cohen in view of U.S. Patent Application Publication No. US 2004/0106927 to Ruffner et al. (hereinafter, “Ruffner”).
As to claim 23, Cohen discloses an instrument for preparing a medullary cavity of a bone for an implant, the instrument comprising: the apparatus according to claim 1.
As to claim 24, Cohen discloses further comprising a preparation plateau (top surface of 96).
Cohen is silent as to wherein the rasp is releasably attached to the fastening device (claim 6); at least two exchangeable drills or at least two exchangeable rasps (claim 23).
Ruffner teaches providing a rasp with a removable head portion so that different size head portions can be provided with a single handle portion such that the appropriate size head portion can be chosen during a surgical procedure to accommodate the particular dimensions of a target patient tissue (par. [0025]), FIG. 9.
Accordingly, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to provide Cohen’s rasp (138) as a separate part that is releasably attached to the fastening device (152), and providing at least two exchangeable rasps of different sizes, so that different size rasp heads can be provided for use with a single fastening device such that the appropriate size rasp head can be chosen during a surgical procedure to accommodate the particular dimensions of a target patient tissue, as taught by Ruffner. Constructing a formerly integral structure in various elements involves only routine skill in the art.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Cohen in view of U.S. Patent No. US 5,445,641 to Frigg et al. (hereinafter, “Frigg”).
As to claim 11, Cohen is silent as to wherein the drill comprises a shaft, wherein at least one part of the shaft is arranged in the guide device, wherein the at least one part of the shaft comprises a taper, and wherein the guide device comprises a constriction that forms the stop.
Frigg teaches a drill (21) comprises a shaft, FIG. 6, wherein at least one part of the shaft is arranged in a guide device (15) (col. 4 / line 3), FIG. 4, wherein the at least one part of the shaft comprises a taper (distal part of shaft is tapered relative to the cylindrical stop on the proximal end of the shaft), and wherein the guide device comprises a constriction that forms the stop (the aperture though the guide device is constricted or narrowed relative to the outside of the guide device and relative to the cylindrical stop on the shaft, and thus stops further movement of the drill through the guide device when the cylindrical stop contacts the guide device).
Accordingly, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to provide Cohen’s drill with a shaft that is arranged in or passes through the guide device (Cohen, at 104), as drill guides are well known in the orthopedic art, and Cohen contemplates a drill that passes through the guide device. As taught by Frigg, the drill would have an enlarged cylindrical stop on the proximal end and a relatively tapered portion of the shaft (the “taper” of the shaft) so that the taper can pass through the guide device with further movement stopped by the cylindrical stop abutting the guide device, therefore preventing over insertion of the drill that would damage the bone. The interior aperture through the guide device that receives the taper of the drill shaft is a constriction because it is constricted or narrowed relative to the outside of the guide device and relative to the cylindrical stop on the shaft, and thus stops further movement of the drill through the guide device when the cylindrical stop contacts the guide device.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Smith in view of Frigg.
As to claim 15, Smith is silent as to wherein the apparatus comprises a coupling device designed to couple the drill and the impact device during a movement counter to the translational direction of movement.
Frigg teaches a drill (21) comprising a cylindrical stop on the proximal end of the shaft to stop further movement of the drill through a guide device, FIGS. 4 and 6.
Accordingly, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to provide Smith’s drill with an enlarged cylindrical stop on the proximal end to stop further movement of the drill through the guide device/impact device upon complete drilling, therefore preventing over insertion of the drill that would damage the bone. This enlarged cylindrical stop is a coupling device that couples the drill and the impact device when the impact device is moved proximally (counter to the translational direction of movement of the rasp) along with the rasp (since the rasp is a distal extension of the impact device), since the drill will move along with the impact device in this counter direction because the enlarged cylindrical stop abuts the proximal end of the impact device and would pull the drill along with it.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TRACY L KAMIKAWA whose telephone number is (571)270-7276. The examiner can normally be reached M-F 10:00-6:30 PM.
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/TRACY L KAMIKAWA/Examiner, Art Unit 3775