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 .
Status of the Claims
Claims 1-15 are presently pending in this application.
Examiner’s Note
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.
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.
Claim(s) 1-8 and 10-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Horan et al. (US 2007/0233106), herein referred to as Horan, and in view of Slocum (US 5,304,180).
Regarding claim 1, Horan discloses a plate (10) (figure 1) for providing cranial and distal compression of an osteotomy cut (considered functional), comprising a body (figure 1) extending longitudinally from a proximal end (considered as the end near element 14) to a distal end (considered as the end near element 12) and defined via a first surface (e.g. top surface, see figure 1) which, in an operative configuration, faces away from a bone (figure 14) and a second surface (e.g. bottom surface, see figure 1) which, in the operative configuration, faces toward the bone (figure 14), the body (figure 1) including a proximal portion (14) configured to (i.e. capable of) be positioned over a cut (figure 14) and repositioned proximal segment of the bone (figure 14) and a distal portion (12) extending along a longitudinal axis L (see figure 1 below) and configured to (i.e. capable of) be positioned over a distal segment of the bone (figure 14), a first distal hole (16) (see figure 1 below) extending through a proximal end of the distal portion (12) of the body (figure 1) from the first surface (e.g. top surface, see figure 1) to the second surface (e.g. bottom surface, see figure 1), the first distal hole (16) (see figure 1 below) being configured to (i.e. capable of) slidably receive a first bone fixation element (e.g. screw, ¶34, ¶35), and a second distal hole (16) (see figure 1 below) extending through the distal portion (12) of the body (figure 1) distally of the first distal hole (16) (see figure 1 below) from the first surface (e.g. top surface, see figure 1) to the second surface (e.g. bottom surface, see figure 1), the second distal hole (16) (see figure 1 below) extending along the axis L (see figure 1 below) and including a sloped compression surface (17, 18) along a distal portion thereof (¶35 and figure 1).
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Yet, Horan lacks the first distal hole extending through the plate along an axis B angled relative to the axis L.
However, Slocum teaches a hole (12a) extending through a plate (10) along an axis B (Aa) angled relative to an axis L (figure 1).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Horan’s plate having a first distal hole with the hole extending through the plate along an axis B angled relative to the axis L as taught by Slocum, since such a modification would urge one tibial segment toward another tibial segment (col. 3, ll. 31-38).
Thus, the modified Horan’s plate has the second distal hole (16 of Horan) (see figure 1 of Horan above) extending along the axis L (see figure 1 of Horan above) and including a sloped compression surface (17, 18 of Horan) along a distal portion thereof (see figure 1 of Horan above) configured (i.e. capable of) so that, when a second bone fixation element (e.g. screw, ¶34, ¶35 of Horan) is inserted into the second distal hole (16 of Horan) (see figure 1 of Horan above), contact between a head of the second bone fixation element (e.g. screw, ¶34, ¶35 of Horan) and the sloped compression surface of the second distal hole (see figure 1 of Horan above) generates a first distal translation of the plate (the modified Horan’s plate) relative to the second bone fixation element (e.g. screw, ¶34, ¶35 of Horan), and wherein the first distal hole (12a of Slocum) is configured (i.e. capable of) such that, the first distal translation of the plate moves the plate relative to the first bone fixation element (e.g. screw, ¶34, ¶35 of Horan) so that the first bone fixation element (e.g. screw, ¶34, ¶35 of Horan) translates along the axis B (Aa of Slocum) toward a proximal end of the first distal hole (16 of Horan) (see figure 1 of Horan above), moving the proximal portion of the plate (the modified Horan’s plate) distally and cranially (due to the modified hole).
Regarding claim 2, the modified Horan’s plate has wherein an angle between the axis L (see figure 1 of Horan above) and the axis B (Aa of Slocum) along which the first distal hole (see figure 1 of Horan above) extends corresponds to a desired cranial displacement (due to the modified hole).
Regarding claim 3, the modified Horan’s plate has wherein the first distal hole (the modified Horan’s first distal hole) is angled relative to the axis L so that a first end is proximal to a second end (figure 1 of Slocum) and the first end is separated transversely from the axis L on a caudal side of the axis L (figure 1 of Slocum) and the second end is separated transversely from the axis L on a cranial side of the axis L (figure 1 of Slocum).
Regarding claim 4, the modified Horan’s plate has wherein the translation of the first bone fixation element (e.g. screw, ¶34, ¶35 of Horan) along the axis B (Aa of Slocum) caused by the first distal translation of the plate (the modified Horan’s plate) rotates the plate about the second bone fixation element (e.g. screw, ¶34, ¶35 of Horan) so that the proximal portion of the plate (the modified Horan’s plate) is moved cranially (due to the modified hole).
Regarding claim 5, the modified Horan’s plate has further comprising a third distal hole (16a of Horan) extending through the distal portion of the body (12 of Horan), between the first and second distal holes (see figure 1 of Horan above), from the first surface (e.g. top surface, see figure 1 of Horan above) to the second surface (e.g. bottom surface, see figure 1 of Horan above) and extending along the axis L (see figure 1 of Horan above), a distal portion of the third distal hole including a sloped compression surface (¶36 and figure 1 of Horan).
Regarding claim 6, the modified Horan’s plate has wherein the third distal hole (16a of Horan) is configured (i.e. capable of) as a combi-hole (¶36 and figure 1 of Horan) including a proximal portion (¶36 and figure 1 of Horan) configured as (i.e. capable of) a locking hole (¶36 and figure 1 of Horan) and a distal portion (¶36 and figure 1 of Horan) configured as (i.e. capable of) a dynamic compression hole (¶36 and figure 1 of Horan), the proximal and distal portions of the combi-hole (¶36 and figure 1 of Horan) being open to and in communication with one another (¶36 and figure 1 of Horan).
Regarding claim 7, the modified Horan’s plate has wherein when the third distal hole (16a of Horan) is configured (i.e. capable of) so that, as a third bone fixation element (e.g. screw, ¶34, ¶35 of Horan) is inserted into the third distal hole (16a of Horan) the sloped compression surface of the third distal hole (¶36 and figure 1 of Horan) provides a second distal translation of the plate (the modified Horan’s plate) relative to the third bone fixation element (e.g. screw, ¶34, ¶35 of Horan), and wherein the first distal hole (16 of Horan) (see figure 1 of Horan above) is configured (i.e. capable of) such that, the second distal translation of the plate moves the plate (the modified Horan’s plate) relative to the first bone fixation element (e.g. screw, ¶34, ¶35 of Horan) so that the plate moves relative to the first bone fixation element (e.g. screw, ¶34, ¶35 of Horan) so that the first bone fixation element (e.g. screw, ¶34, ¶35 of Horan) moves along the axis B (Aa of Slocum) toward a first end of the first distal hole (16 of Horan) (see figure 1 of Horan above), moving the proximal portion of the plate further distally and cranially (due to the modified hole).
Regarding claim 8, the modified Horan’s plate has wherein the translation of the plate (the modified Horan’s plate) relative to the first bone fixation element (e.g. screw, ¶34, ¶35 of Horan) along the axis B (Aa of Slocum) caused by the second distal translation of the plate causes the plate to rotate about the third bone fixation element (e.g. screw, ¶34, ¶35 of Horan) so that the proximal portion of the plate moves cranially (due to the modified hole).
Regarding claim 10, Horan discloses a method comprising positioning a bone plate (10) (figure 1) in an initial position with a first surface (e.g. top surface, see figure 1) of the bone plate (10) facing away from a tibia (figure 14) and a second surface (e.g. bottom surface, see figure 1) thereof facing the tibia (figure 14) so that a distal portion (12) of the bone plate (10) extends over a distal tibial segment (figure 14) and a proximal portion (14) of the bone plate (10) extends over a proximal tibial segment (figure 14) that has been cut away from the proximal tibial segment (figure 14), rotated and seated within a recess formed in the distal tibial segment when the proximal tibia segment was cut away (¶41), coupling the proximal portion (14) of the bone plate (10) to the proximal tibial segment (figure 14), inserting a first distal bone fixation element (e.g. screw, ¶34, ¶35) into the distal tibial segment of the tibia (figure 14) via a first distal hole (16) (see figure 1 above), inserting a second distal bone fixation element (e.g. screw, ¶34, ¶35) into the distal tibial segment (figure 14) via a second distal hole (16) (see figure 1 above) extending through the distal portion of the bone plate (10) distally of the first distal hole (16) (see figure 1 above).
Yet, Horan lacks the first distal hole extending along an axis B angled relative to a longitudinal axis L of a distal portion of the bone plate.
However, Slocum teaches a hole (12a) extending through a plate (10) along an axis B (Aa) angled relative to an axis L (figure 1).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Horan’s method having a plate having a first distal hole with the hole extending through the plate along an axis B angled relative to the axis L as taught by Slocum, since such a modification would urge one tibial segment toward another tibial segment (col. 3, ll. 31-38).
Thus, the modified Horan’s method for providing cranial and distal compression of an osteotomy cut comprises a head portion of the second distal bone fixation element (e.g. screw, ¶34, ¶35 of Horan) slides along a sloped compression surface (17, 18 of Horan) forming an edge of a distal portion of the second distal hole (16 of Horan) to move the bone plate (the modified Horan’s plate) distally relative to the second distal bone fixation element (e.g. screw, ¶34, ¶35 of Horan) pulling the proximal portion of the bone plate (the modified Horan’s plate) and the proximal tibial segment (figure 14 of Horan) distally to provide a first distal compression between the proximal tibial segment (the modified Horan’s plate) and the distal tibial segment (the modified Horan’s plate), the bone plate (the modified Horan’s plate) translating relative to the first distal bone fixation element (e.g. screw, ¶34, ¶35 of Horan) so that the first distal bone fixation element (e.g. screw, ¶34, ¶35 of Horan) translates proximally along the axis B (Aa of Slocum) during the first distal compression rotating the bone plate (the modified Horan’s plate) about the second distal bone fixation element (e.g. screw, ¶34, ¶35 of Horan) so that the proximal portion of the bone plate (the modified Horan’s plate) moves cranially to provide a first cranial compression of the proximal tibial segment (figure 14 of Horan) against the distal tibial segment (figure 14 of Horan) (due to the modified hole).
Regarding claim 11, the modified Horan’s method has wherein an angle between the axis L (see figure 1 of Horan above) and the axis B (Aa of Slocum) corresponds to a desired cranial displacement (due to the modified hole) and the first distal hole (the modified Horan’s first distal hole) is angled so that a first end is proximal to a second end (figure 1 of Slocum) and the first end is separated transversely from the axis L on a caudal side of the axis L (figure 1 of Slocum) and the second end is separated transversely from the axis L on a cranial side of the axis L (figure 1 of Slocum).
Regarding claim 12, the modified Horan’s method has wherein the translation of the first bone fixation element (e.g. screw, ¶34, ¶35 of Horan) along the axis B (Aa of Slocum) caused by the first distal translation of the plate (the modified Horan’s plate) rotates the plate about the second bone fixation element (e.g. screw, ¶34, ¶35 of Horan) to move the proximal portion of the bone plate (the modified Horan’s plate) cranially (due to the modified hole).
Regarding claim 13, the modified Horan’s method has wherein a third distal hole (16a of Horan) extends through the distal portion of the bone plate (the modified Horan’s plate), between the first and second distal holes (see figure 1 of Horan above), from the first surface (e.g. top surface, see figure 1 of Horan above) to the second surface (e.g. bottom surface, see figure 1 of Horan above) and extending along the axis L (see figure 1 of Horan above), a distal portion of the third distal hole including a sloped compression surface (¶36 and figure 1 of Horan).
Regarding claim 14, the modified Horan’s method has further comprising inserting a third bone fixation element (e.g. screw, ¶34, ¶35 of Horan) into the third distal hole (16a of Horan) so that the sloped compression surface of the third distal hole (¶36 and figure 1 of Horan) provides a second distal translation of the bone plate (the modified Horan’s plate) relative to the third bone fixation element (e.g. screw, ¶34, ¶35 of Horan), and a second cranial compression of the proximal tibial segment (figure 14 of Horan) against the distal tibial segment (figure 14 of Horan) (due to the modified hole).
Allowable Subject Matter
Claims 9 and 15 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Response to Arguments
Applicant's arguments filed January 27, 2026 have been fully considered but they are not persuasive.
Applicant’s arguments on pages 2-9, under 35 U.S.C. 103, of the Remarks are directed to the combination of references (Horan in view of Slocum). Applicant argues that “Notably, as seen in Figure 1, the elongate hole 12a in Slocum is not located in the distal portion of the body (second subframe means 14). Instead, the elongate hole 12a in Slocum is located in a proximal portion (first subframe means 12) of the body. Thus, the elongate hole 12a in Slocum cannot be the claimed ''first distal hole extending through a proximal end of the distal portion of the body from the first surface to the second surface, the first distal hole extending through the plate along an axis B angled relative to the axis L," as recited in claim 1.” However, the Examiner respectfully disagrees because the primary reference Horan discloses a first distal hole (16) (see figure 1 above) extending through a proximal end of the distal portion (12) of the body (figure 1) from the first surface (e.g. top surface, see figure 1) to the second surface (e.g. bottom surface, see figure 1). The reference Slocum was used to specifically teach a hole (12a) extending through a plate (10) along an axis B (Aa) angled relative to an axis L (figure 1). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Horan’s plate having a first distal hole with the hole extending through the plate along an axis B angled relative to the axis L as taught by Slocum, since such a modification would urge one tibial segment toward another tibial segment (col. 3, ll. 31-38). The Examiner notes that the first distal hole is already in the distal portion and the reference Slocum is used to teach an angled hole.
Applicant argues the feature of “a second distal hole extending through the distal portion of the body distally of the first distal hole from the first surface to the second surface, the second distal hole extending along the axis L and including a sloped compression surface along a distal portion thereof configured so that, when a second bone fixation element is inserted into the second distal hole, contact between a head of the second bone fixation element and the sloped compression surface of the second distal hole generates a first distal translation of the plate relative to the second bone fixation element, and wherein the first distal hole is configured such that, the first distal translation of the plate moves the plate relative to the first bone fixation element so that the first bone fixation element translates along the axis B toward a proximal end of the first distal hole, moving the proximal portion of the plate distally and cranially” and “It is respectfully submitted that the compression resulting from the insertion of a bone fixation element inserted through the hole 16 labeled as the second distal hole in the annotated Fig. 1 of Horan has no bearing to compression achieved via the first distal hole 16 in the annotated Fig. 1 of Horan, as required by the recited claim. While it is clear that the first and second distal holes of the recited claim 1 are configured to cooperate to achieve distal and cranial compression, it is respectfully submitted that the holes in Horan are configured to provide individual compressive forces that are separate and distinct from one another and which are not modifiable as suggested by the Examiner to achieve the desired results.” However, the Examiner respectfully disagrees. Applicant’s arguments regarding “Horan are configured to provide individual compressive forces that are separate and distinct from one another and which are not modifiable as suggested by the Examiner to achieve the desired results” appears to be mere allegations. Thus, it is the modified Horan’s plate that has the second distal hole (16 of Horan) (see figure 1 of Horan above) extending along the axis L (see figure 1 of Horan above) and including a sloped compression surface (17, 18 of Horan) along a distal portion thereof (see figure 1 of Horan above) configured (i.e. capable of) so that, when a second bone fixation element (e.g. screw, ¶34, ¶35 of Horan) is inserted into the second distal hole (16 of Horan) (see figure 1 of Horan above), contact between a head of the second bone fixation element (e.g. screw, ¶34, ¶35 of Horan) and the sloped compression surface of the second distal hole (see figure 1 of Horan above) generates a first distal translation of the plate (the modified Horan’s plate) relative to the second bone fixation element (e.g. screw, ¶34, ¶35 of Horan), and wherein the first distal hole (12a of Slocum) is configured (i.e. capable of) such that, the first distal translation of the plate moves the plate relative to the first bone fixation element (e.g. screw, ¶34, ¶35 of Horan) so that the first bone fixation element (e.g. screw, ¶34, ¶35 of Horan) translates along the axis B (Aa of Slocum) toward a proximal end of the first distal hole (16 of Horan) (see figure 1 of Horan above), moving the proximal portion of the plate (the modified Horan’s plate) distally and cranially (due to the modified hole). A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
Conclusion
THIS ACTION IS MADE FINAL. 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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/SI MING KU/Primary Examiner, Art Unit 3775
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