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 .
Response to Amendment
This Office Action is responsive to the amendment filed on 11 December 2025. As directed by the amendment: claims 1-5 and 11-16 are cancelled, and claim 30 is newly added. Claims 6-10 and 17-30 currently stand pending in the application.
Response to Arguments
Applicant's arguments filed 11 December 2025 with respect to the rejections under 35 U.S.C. 103 have been fully considered but they are not persuasive.
Applicant contends that Boehner (US 8,932,156) is not analogous art. Examiner respectfully submits that Boehner is analogous art because it is reasonably pertinent to the problem faced by the inventor; Boehner is relied upon to teach locking of relatively rotationally sliding parts. The rest of the structure is disclosed by Austin (US 6,129,727). The claimed invention as a whole is thus obvious over Austin in view of Boehner. A POSITA would have looked to Boehner for a means to lock relatively rotationally sliding parts.
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971). The cited references provide the knowledge which was within the level of ordinary skill in the art before the effective filing date of the claimed invention.
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 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent No. US 6,129,727 to Austin et al. (hereinafter, “Austin”), in view of U.S. Patent No. US 8,932,156 to Boehner.
As to claim 6, Austin discloses an apparatus for fixating a bone, the apparatus comprising: an external fixator ring (18) defining therethrough a plurality of arcuately spaced apart arcuately elongated slots (17), FIG. 1; a bone fixation pin (pin passing through P in FIG. 1 and entering bone B2 in FIG. 2) (col. 5 / lines 31-43); and a jig (P) configured to hold said bone fixation pin and configured to be coupled to said external fixator ring through one of said slots, FIG. 1, wherein said jig defines a first through hole (inferior-most hole through outer face portion of P) configured to receive said bone fixation pin therethrough, said jig defines a second through hole (inferior-most hole through inner face portion of P) configured to cooperate with said first through hole to concurrently receive and align said bone fixation pin through said first through hole and said second through hole, FIG. 1, said jig defines a third through hole (superior-most hole through outer face portion of P) configured to receive said bone fixation pin therethrough, and said jig defines a fourth through hole (superior-most hole through inner face portion of P) configured to cooperate with said third through hole, alternatively to said first through hole and said second through hole, to concurrently receive and align said bone fixation pin through said third through hole and said fourth through hole (when the pin is disposed in the superior position to that shown in FIG. 1).
Austin is silent as to the external fixator ring defining therethrough a plurality of arcuately spaced apart apertures, the slots radially outwardly offset from said apertures, the jig configured to be coupled to said external fixator ring concurrently through both one of said apertures and one of said slots.
Boehner teaches a first component (612) defining therethrough a plurality of arcuately spaced apart apertures (35) and further defining therethrough an arcuately elongated slot (36) radially offset from said apertures (col. 4 / lines 13-36), FIG. 7; and a second component (31) configured to be coupled to said first component concurrently through both one of said apertures and said slot (when locked), in order to allow rotational sliding between the parts that can be locked in discrete positions when the components are coupled through both the aperture and the slot.
Accordingly, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Austin’s external fixator ring to include a series of apertures along its length, arcuately spaced apart about the arc-shaped ring, adjacent to and radially offset from the plurality of arcuately spaced apart arcuately elongated slots, and to modify Austin’s jig to include a member that can be selectively positioned within one of the apertures at a position in which it is desired to be locked, as taught by Boehner, in order to allow sliding of the jig relative to the ring to adjust the position of the bone fixation pin for best targeting the bone when the member is not positioned within or engaged to the respective aperture, while also allowing more secure coupling between the jig and the ring when the member is positioned within and engaged to the respective aperture, with two points of coupling preventing undesired rotation or twisting of the jig. When in the locked position, the jig is coupled to the ring concurrently through both the one of the plurality of apertures in which the member taught by Boehner is engaged and the one of the slots through which the screw disclosed by Austin is engaged. Austin’s ring may be modified in width so as to accommodate the series of arcuately spaced apart apertures alongside the slots as taught by Boehner, and the jig would be modified in size so as to accommodate the screw that couples through the slot as well as the member that couples through the aperture, with the member on the jig aligning with the series of apertures.
Further, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to offset the slots radially outward from the apertures, since a mere reversal of the essential working parts of a device involves only routine skill in the art (reversing which of the apertures and slots are radially outwardly offset), and arranging the slots relative to the apertures so that the sots are radially outwardly offset from the apertures would still allow the jig to be selectively locked in position via one of the apertures after sliding along the respective one of the slots. The apertures would be spaced along the arc-shaped ring along an arcuate path along an inner portion of the ring. The member that couples through the respective aperture would be positioned on the jig in the appropriate location to engage with the apertures, i.e. in line with the series of arcuately spaced apart apertures. The screw that couples through the slot would be positioned on the jig in the appropriate location to engage with the slots.
As to claim 21, Austin discloses an apparatus for fixating a bone, the apparatus comprising: an external fixator ring (18) defining therethrough a first arcuately elongated slot (17), FIG. 1, said external fixator ring further defining therethrough a second arcuately elongated slot (17) arcuately spaced apart from said first arcuately elongated slot, FIG. 1; a bone fixation pin (pin passing through P in FIG. 1 and entering bone B2 in FIG. 2) (col. 5 / lines 31-43); and a jig (P) configured to hold said bone fixation pin and configured to be alternatively coupled to said external fixator ring either through said first arcuately elongated slot or through said second arcuately elongated slot, wherein said jig defines a first through hole (inferior-most hole through outer face portion of P) configured to receive said bone fixation pin therethrough, said jig defines a second through hole (inferior-most hole through inner face portion of P) configured to cooperate with said first through hole to concurrently receive and align said bone fixation pin through said first through hole and said second through hole, FIG. 1, said jig defines a third through hole (superior-most hole through outer face portion of P) configured to receive said bone fixation pin therethrough, and said jig defines a fourth through hole (superior-most hole through inner face portion of P) configured to cooperate with said third through hole, alternatively to said first through hole and said second through hole, to concurrently receive and align said bone fixation pin through said third through hole and said fourth through hole (when the pin is disposed in the superior position to that shown in FIG. 1).
Austin is silent as to the external fixator ring defining therethrough a first set of at least three arcuately spaced apart apertures, the first arcuately elongated slot radially outwardly offset from said first set of arcuately spaced apart apertures, said external fixator ring further defining therethrough a second set of at least three arcuately spaced apart apertures arcuately spaced apart from said first set of arcuately spaced apart apertures, the second arcuately elongated slot radially outwardly offset from said second set of arcuately spaced apart apertures; and the jig configured to be alternatively coupled to said external fixator ring either concurrently through both an aperture of said first set of arcuately spaced apart apertures and said first arcuately elongated slot or concurrently through both an aperture of said second set of arcuately spaced apart apertures and said second arcuately elongated slot.
Boehner teaches a first component (612) defining therethrough a first set of at least three arcuately spaced apart apertures (35) and further defining therethrough a first arcuately elongated slot (36) radially offset from said first set of arcuately spaced apart apertures (col. 4 / lines 13-36), FIG. 7; and a second component (31) configured to be coupled to said first component concurrently through both an aperture of said first set of arcuately spaced apart apertures and said first arcuately elongated slot (when locked), in order to allow rotational sliding between the parts that can be locked in discrete positions when the components are coupled through both the aperture and the slot.
Accordingly, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Austin’s external fixator ring to include a series of apertures along its length, arcuately spaced apart about the arc-shaped ring, adjacent to and radially offset from the first and second arcuately spaced apart arcuately elongated slots, and to modify Austin’s jig to include a member that can be selectively positioned within one of the apertures at a position in which it is desired to be locked, as taught by Boehner, in order to allow sliding of the jig relative to the ring to adjust the position of the bone fixation pin for best targeting the bone when the member is not positioned within or engaged to the respective aperture, while also allowing more secure coupling between the jig and the ring when the member is positioned within and engaged to the respective aperture, with two points of coupling preventing undesired rotation or twisting of the jig. When in the locked position, the jig is coupled to the ring concurrently through both the one of the plurality of apertures in which the member taught by Boehner is engaged and the first slot through which the screw disclosed by Austin is engaged, or through one of the apertures and the second slot. Austin’s ring may be modified in width so as to accommodate the series of arcuately spaced apart apertures alongside the slots as taught by Boehner, and the jig would be modified in size so as to accommodate the screw that couples through the slot as well as the member that couples through the aperture, with the member on the jig aligning with the series of apertures.
Further, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to offset the slots radially outward from the apertures, since a mere reversal of the essential working parts of a device involves only routine skill in the art (reversing which of the apertures and slots are radially outwardly offset), and arranging the slots relative to the apertures so that the sots are radially outwardly offset from the apertures would still allow the jig to be selectively locked in position via one of the apertures after sliding along the respective one of the slots. The apertures would be spaced along the arc-shaped ring along an arcuate path along an inner portion of the ring. The member that couples through the respective aperture would be positioned on the jig in the appropriate location to engage with the apertures, i.e. in line with the series of arcuately spaced apart apertures. The screw that couples through the slot would be positioned on the jig in the appropriate location to engage with the slots.
Further, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to group and space the plurality of apertures as taught by Boehner to form a first set of at least three arcuately spaced apart apertures, adjacent to and radially inwardly offset from the first arcuately elongated slot, and a second set of at least three arcuately spaced apart apertures, arcuately spaced apart from the first set and adjacent to and radially inwardly offset from the second arcuately elongated slot, since applicant has not disclosed that this particular number of apertures solves any stated problem or is anything more than one of numerous configurations a person having ordinary skill in the art would find obvious for the purpose of providing multiple locking locations along a curved path of travel along an adjacent slot. The apertures, all arcuately spaced apart along the arc-shaped ring, would be spaced and arranged along the ring such that a first set of three apertures is adjacent to and associated with the first slot so that, when the jig is coupled to and slides along the first slot, it can be locked in one of the three positions associated with the three apertures of the first set. A second set of three apertures is adjacent to and associated with the second slot so that, when the jig is coupled to and slides along the second slot, it can be locked in one of the three positions associated with the three apertures of the second set. The jig would thus be coupled to the ring either concurrently through both an aperture of the first set of apertures and the first slot, or concurrently through both an aperture of the second set of apertures and the second slot. As applied to Austin, each of the slots shown would have a corresponding set of apertures adjacent to and associated therewith for positionally locking the jig when it is coupled to the respective slot.
Claims 7-10 and 22-25 are rejected under 35 U.S.C. 103 as being unpatentable over Austin in view of Boehner (hereinafter, “Austin/Boehner”), as applied to claim 6 above, and further in view of U.S. Patent No. US 9,936,975 to Siemer et al. (hereinafter, “Siemer”).
As to claims 8 and 23, Austin/Boehner disclose wherein said jig comprises a first face portion (outer face portion/wall of P) defining said first through hole and defining said third through hole, said jig comprises a second face portion (inner face portion/wall of P) defining said second through hole and defining said fourth through hole, and said jig comprises a third face portion (lateral face portion/wall of P), FIG. 1.
As to claims 9 and 24, Austin/Boehner disclose wherein said jig is generally cuboidal, FIG. 1.
Although Austin appears to show a first member extending through a fifth through hole of a third face portion (lateral face portion/wall of P) of the jig, FIG. 1, Austin is silent as to further comprising: a first threaded member, wherein said jig defines a fifth through hole, and said first threaded member extends through said fifth through hole into abutment with said bone fixation pin (claims 7 and 22); the third face portion defining said fifth through hole (claims 8 and 23); wherein said first threaded member comprises at least one of a first bolt and a first screw (claims 10 and 25).
As to claims 6 and 21, Siemer teaches an apparatus for fixating a bone, the apparatus comprising: an external fixator ring (200) defining therethrough a plurality of arcuately spaced apart apertures (col. 8 / lines 20-29), FIGS. 1 and 19A; a bone fixation pin (1700); and a jig (1760) configured to hold said bone fixation pin and configured to be coupled to said external fixator ring through one of said apertures, FIG. 19A, wherein said jig defines a first through hole (superior-most hole through outer face portion of 1760) configured to receive said bone fixation pin therethrough (col. 21 / lines 43-65), said jig defines a second through hole (superior-most hole through inner face portion of 1760) configured to cooperate with said first through hole to concurrently receive and align said bone fixation pin through said first through hole and said second through hole (when pin is passed through the first and second through holes in a position superior to the one shown in FIG. 19A), said jig defines a third through hole (hole beneath the first through hole through outer face portion of 1760) configured to receive said bone fixation pin therethrough, and said jig defines a fourth through hole (hole beneath the second through hole through inner face portion of 1760) configured to cooperate with said third through hole, alternatively to said first through hole and said second through hole, to concurrently receive and align said bone fixation pin through said third through hole and said fourth through hole, FIG. 19A.
As to claims 7 and 22, Siemer teaches a first threaded member (setscrew), wherein said jig defines a fifth through hole (superior-most hole through lateral face portion of 1760), FIG. 19A, and said first threaded member extends through said fifth through hole into abutment with said bone fixation pin (col. 21 / lines 49-56).
As to claims 8 and 23, Siemer teaches wherein said jig comprises a first face portion (outer face portion/wall of 1760) defining said first through hole and defining said third through hole, said jig comprises a second face portion (inner face portion/wall of 1760) defining said second through hole and defining said fourth through hole, and said jig comprises a third face portion (lateral face portion/wall of 1760) defining said fifth through hole.
As to claims 9 and 24, Siemer teaches wherein said jig is generally cuboidal, FIG. 19B.
As to claims 10 and 25, Siemer teaches wherein said first threaded member comprises at least one of a first bolt and a first screw (col. 21 / lines 49-56).
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 the apparatus of Austin/Boehner with a threaded setscrew (the first threaded member) that passes through a threaded fifth through hole through the third face portion, into abutment with the bone fixation pin, so that the threaded setscrew can be securely passed into the fifth through hole and into abutment with the bone fixation pin to tighten down on and anchor the pin in place, as taught by Siemer, with the threaded interaction allowing fine adjustments during tightening down while also being reversible so that the threaded setscrew and subsequently the bone fixation pin can be removed if so desired. Threaded setscrews are well known in the orthopedic art.
Claims 17-20 and 26-30 are rejected under 35 U.S.C. 103 as being unpatentable over Austin in view of Boehner and Siemer (hereinafter, “Austin/Boehner/Siemer”), as applied to claims 7-10 above.
As to claims 17 and 26, Austin/Boehner/Siemer disclose further comprising: a second member (Boehner, 34, as modified in view of Boehner), and a third threaded member (screw shown in an exploded view in Austin, FIG. 1, that fixes jig P to ring 18), wherein said jig defines a sixth through hole (as modified in view of Boehner, to receive the second member 34 that is positioned through a respective aperture) and defines a seventh through hole (hole in top surface of P shown in Austin), said second member extends through said aperture into said sixth through hole (as modified in view of Boehner), and said third threaded member extends through said slot into said seventh through hole, Austin FIGS. 1-2.
As to claims 18 and 27, Austin/Boehner/Siemer disclose wherein said jig comprises a fourth face portion (top face portion/wall) defining said sixth through hole and defining said seventh through hole, Austin FIG. 1.
As to claims 20 and 29, Austin/Boehner/Siemer disclose wherein said third threaded member comprises at least one of a third bolt and a third screw, Austin FIG. 1.
As to claim 30, Austin/Boehner/Siemer disclose wherein said third threaded member is a third screw, Austin FIG. 1.
Austin/Boehner/Siemer are silent as to the second member being a second threaded member that comprises at least one of a second bolt and a second screw.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to comprise the second member that couples the jig to the aperture of the ring as a second screw, since the mere duplication of the essential working parts of a device involves only routine skill in the art, and providing two screws, one for coupling the jig to the ring via the slot and one for coupling the jig to the ring via the aperture, is within the ordinary skill in the art, and would allow the jig to be fixed to the ring once it has reached its desired orientation by threading the screw through the ring aperture into the respective hole in the jig, while also allowing repositioning of the jig by unthreading the screw. The simple substitution of one known element for another (replacing the locking pin of Boehner with a screw) to obtain predictable results (reversible coupling through aligned holes) is within the ordinary skill in the art.
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 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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kevin Truong, can be reached at 571-272-4705. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/TRACY L KAMIKAWA/Examiner, Art Unit 3775