DETAILED ACTION
This office action is responsive to the amendment filed March 19, 2026. By that response, claims 1, 10, 12, 27, 29, and 30 were amended; claim 31 is canceled; and claim 33 is newly presented. Claims 1-17, 21-30, 32 and 33 are pending.
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 Arguments
The outstanding objections to claims 1 and 30 were overcome by the amendments of March 19, 2026.
Applicant’s arguments with respect to the rejections of claim(s) 1-17 and 21-32 have been considered but are moot because the new grounds of rejection do not rely on any combination of references applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. As agreed in the examiner interview of March 13, 2026, the amendments overcame the rejections of record.
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, 2, 4-14, 17, 21-26, 30, and 32 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gonzalez-Hernandez (US 2014/0277177 A1) in view of Tiongson et al. (US 10,856,920 B2).
Regarding claim 1, Gonzalez-Hernandez teaches a bone plate system for a long bone of a patient (e.g. femur, [0003], [0010], [0045], claim 16), the bone plate system comprising a bone plate as at fig. 1 comprising:
a body 10 having a first end (down in fig. 1), a second end (up in fig. 1), a superior surface (15A, out of the page in fig. 1) that is configured to face away from the long bone R, and a bone-facing surface (15B, into the page in fig. 1) that is configured to face a first side of the long bone when the bone plate is in use, the long bone R comprising the first side, a second side (right side), a third side (left side), and a fourth side (into the page, behind the bone R); and
a low-profile fixation assembly 50 configured to secure the first end (e.g. bottom half in fig. 1) to the long bone R, the low-profile fixation assembly 50 configured to fixate the first end to the long bone by approaching the first end from the second side or the third side (two elements 50 are shown which approach from opposed sides);
wherein:
the second end (up in fig. 1) comprises a distal fixation feature 16; and
the distal fixation feature 16 comprises a plurality of fastener openings 40 proximate the epicondyle.
Gonzalez-Hernandez fails to teach the distal fixation feature 16 comprises a curvature that is shaped to match a profile of an epicondyle of the long bone.
Tiongson teaches a plate 100 at fig. 3 including a distal fixation feature 146 which is “designed to reside or sit on the epicondyle”… (col. 8, lines 19-41). Tiongson’s portion 146 includes a plurality of fastener openings proximate the epicondyle 140a-h.
It would have been obvious to one with ordinary skill in the art at the time of the invention to modify the Gonzalez-Hernandez fixation feature 16 to be of the configuration of the portion 146 of Tiongson. One would have done so in order to permit the surgeon to “key the bone plate into place on the condylar surface”; and “stabilize the bone plate over a bone”, etc. (col. 8, lines 30-41)
Regarding claim 2, the low-profile fixation assembly 50 comprises a fastener opening 52/100 (seen in figs. 1 and 13; labeled in figs. 1 and 16A) that extends from the bone-facing surface towards the superior surface; and a fastener (seen but not labeled in fig. 13) having a proximal end (head seen in the hole) and a distal end (end of the screw mounted in the bone), the distal end comprising a set of threads configured to engage corresponding threads of the fastener opening – details of the fastener are not demonstrated, but examiner takes official notice of fasteners with Phillips headed drivers, as shown in the figures, being threaded screws. Further, [0057] discusses fasteners used in the system being of various configurations, including threads formed thereon for engaging with corresponding structures of the apertures in the plate.
Regarding claim 4, the low-profile fixation assembly 50 comprising: a first arm proximal to the first end (arm 50 closest to the bottom in fig. 1), the first arm comprising: a second superior surface that faces away from the long bone (out of the page), and a second bone-facing surface that faces the third side of the long bone R when the bone plate is in use as in fig. 1; wherein the first arm 50 extends from the body in one of an anterior direction and a posterior direction in relation to the long bone R (depending on placement of the plate on the bone, there is no reason that 50 cannot extend over the anterior or posterior surface, thereof); and a fastener 100 configured to engage with the first arm to fixate the first end to the long bone as seen in figs. 13.
Regarding claim 5, further comprising: a fastener opening 100 connected to the first arm (seen in fig. 1, labeled in fig. 16A), the fastener opening 10 extending through the first arm 50, the fastener opening comprising internal threads; wherein the fastener includes external threads configured to engage with the third side of the long bone. [0057]; also note [0056] which describes the same opening 100 as element 52, for use with fastener 26).
Regarding claim 6, the fastener is capable of engage the fastener opening 100/52 by passing first through the fastener opening and then into the third side of the long bone. See fig. 16B.
Regarding claim 7, the fastener is configured to engage the fastener opening 52/100 by passing first through a side other than the first side of the long bone, then through the third side of the long bone, and then into the fastener opening. While such an arrangement is not shown in the prior art, there is no reason a screw could not be guided in the claimed manner to interact with the claimed aperture.
Regarding claim 8, the low-profile fixation assembly 50 further comprises: a second arm 50 positioned between the second end and the first arm 50 as seen in fig. 1, the second arm comprising: a third superior surface that faces away from the long bone (out of the page in fig. 1), and a third bone-facing surface that faces a side other than the first side of the long bone when the bone plate is in use (as in fig. 1, side of second 50 into the page); wherein the second arm 50 is capable of extending from the body 10 in one of the anterior direction and the posterior direction in relation to the long bone depending on positioning of the plate upon the bone; and a second fastener configured to engage with the second arm to fixate a portion of the body to the long bone (fasteners 26 described at [0056] for insertion into the arms 50, seen at fig. 13).
Regarding claim 9, the low-profile fixation assembly 50 comprises: a fastener opening 52/100 that extends from the bone-facing surface into the body 10 and positioned proximal to (close to) the first end (down in fig. 1; seen in figs. 1, 13, 16A), the fastener opening 52/100 having internal threads [0056-0057]; and a fastener 26/42 comprising: a proximal end; a distal end; a length greater than a diameter of the long bone proximal to (close to) the fastener opening (see fig. 16B); and external threads near the distal end, the external threads configured to engage with the internal threads of the fastener opening [0056-0057]; wherein the distal end of the fastener is capable of entering the fastener opening 52/100 from the bone-facing surface and engage the internal threads towards the superior surface of the body (depending on how the screw is inserted into the bone/plate; depending on size of the screw as provided by [0056-0057].
Regarding claim 10, as can be seen at fig. 1 of Tiongson, the bone plate is curved to approximate a shape of the long bone as seen in figs. 1-7; and configured to extend along a medial side 13 of the long bone.
Regarding claim 11, the low-profile fixation assembly 50 includes an anterior arm 50 proximal to (close to) the first end (the first arm 50, capable of extending to the anterior side of the bone, depending on placement of the plate on the bone), the anterior arm 50 comprising: a second superior surface that faces away from the long bone (out of the page in fig. 1); and a second bone-facing surface that faces an anterior side of the long bone when the bone plate is in use (into the page in fig. 1); the anterior arm is capable of extending from the body 10 around to the anterior side of the long bone; an anterior fastener opening 52/100; an anterior fastener 26/42 capable of engaging with the anterior fastener opening 52/100; a posterior arm (second arm 50) proximal to (close to) the first end (up in fig. 1), the posterior arm including a third superior surface that faces away from the long bone (out of the page in fig. 1); and a third bone-facing surface (into the page in fig. 1) that is capable of facing a posterior side of the long bone when the bone plate is in use as laid out in fig. 1, the posterior side opposite the anterior side; wherein the posterior arm is capable of extending from the body 10 around to the posterior side of the long bone (depending on placement of the plate on the bone); a posterior fastener opening 52/100; and a posterior fastener 26/42 configured to engage with the posterior fastener opening 52/100.
Regarding claim 21, each of the plurality of fastener openings 40 proximate the epicondyle (close to the epicondyle) is oriented obliquely relative to a surface of the epicondyle as best seen at figs. 1 and 2.
Regarding claim 22, the entire second end 16 (and as modified at 146) is enlarged relative to the body 10.
Regarding claim 23, the second end 16 (as modified in the proposal) further includes one or more fingers 50 extending from the second end, each finger comprising an opening 52/100 configured to receive a fastener. Examiner notes no structural distinction is required in the claim between the low-profile fixation feature and the fingers, such that the two elements 50 near the bottom end can be referred to as fixation features while the two elements 50 at the top end can be referred to as fingers.
Regarding claim 12, Gonzalez-Hernandez teaches a bone plate at fig. 1 capable of being placed on a medial side of a femur of a patient ([0003], [0010], [0045], claim 16), the medial bone plate comprising:
a body 10 capable of extending along a medial side of the femur, when in use ([0003], [0010], [0045], claim 16);
a proximal end (down in fig. 1) comprising a first arm 50 capable of extending out over an anterior side of the femur, when in use, the first arm comprising at least one fastener opening 52/100; and
a distal end (up in fig. 1) comprising a distal fixation feature 16 comprising one or more fastener openings 40, the distal fixation feature 16 capable of engaging a medial epicondyle of the femur;
wherein:
the entire distal fixation feature 16 is enlarged relative to the body 10; and
the distal fixation feature 16 is shaped as at fig. 1.
The distal fixation feature 16 does not include a curvature that is shaped to match a profile of the medial epicondyle of the femur.
Tiongson’s plate is for use on a femur (abstract). The plate 100 at fig. 3 includes a distal fixation feature 146 which is “designed to reside or sit on the epicondyle”… (col. 8, lines 19-41). Tiongson’s portion 146 includes a plurality of fastener openings proximate the epicondyle 140a-h. The epicondyle can be seen to be a medial epicondyle as at fig. 1 (side 13).
It would have been obvious to one with ordinary skill in the art at the time of the invention to modify the Gonzalez-Hernandez fixation feature 16 to be of the configuration of the portion 146 of Tiongson. One would have done so in order to permit the surgeon to “key the bone plate into place on the condylar surface”; and “stabilize the bone plate over a bone”, etc. (col. 8, lines 30-41)
Regarding claims 13 and 14, the first arm 50 (at least one of the arms 50) extends from the body in an anterior direction in relation to the femur having the when the proposed modified plate is installed as intended with the distal fixation feature 146 engaging the epicondyle.
Regarding claim 17, the distal end (up in fig. 1) as modified to be formed like 146 of Tiongson, is configured to be positioned proximal to (close to) the medial epicondyle of the femur and the proximal end (down in fig. 1) is capable of being positioned proximal to (close to) a proximal metaphysis of the femur, the medial bone plate further comprising a second arm 50 that capable of extending from the body 10 over the anterior side of the femur, the second arm is positioned between the distal fixation feature 16 and the first arm 50.
Regarding claim 24, the distal fixation feature 16, as modified to be similar to 146, comprises a plurality of fastener openings 140a-h each of the plurality of fastener openings being obliquely oriented relative to a surface of the medial epicondyle as seen at figs. 1 and 3 of Tiongson.
Regarding claim 25, the entire distal fixation feature 146 is enlarged relative to the body 10 as in fig. 1 of Tiongson.
Regarding claim 26, the distal fixation feature 16 comprises one or more fingers 50 extending from the distal fixation feature 16, each finger 50 comprising an opening 52/100 configured to receive a fastener. Examiner notes no structural distinction is required in the claim between the low-profile fixation feature and the fingers, such that the two elements 50 near the bottom end can be referred to as fixation features while the two elements 50 at the top end can be referred to as fingers.
Regarding claim 30, Gonzalez-Hernandez teaches a bone plate at fig. 1 capable of use on a medial femur of a patient ([0003], [0010], [0045], claim 16), the medial bone plate comprising:
a body 10 capable of extending along a medial side of the femur, when in use;
a proximal end (down in fig. 1) comprising a first arm 50 that is configured to extend out over an anterior side of the femur, when in use, the first arm 50 comprising at least one fastener opening 52/100; and
a distal end (up in fig. 1) comprising a distal fixation feature 16 comprising one or more fastener openings 40;
wherein:
the proximal end comprises a second arm 50 that, when in use, extends out over the anterior side of the femur, the second arm comprising at least one fastener opening 52/100 (either: 1) it can be argued that the second arm 50 on the same side as the first is in a ‘proximal end’ of the plate; or 2) it can be noted that additional arms are permitted by the disclosure of “at least one” [0006], claim 1, etc.) ;
the medial bone plate is monolithically formed as a single piece; and
the distal end at 16 is enlarged relative to the body.
Gonzalez-Hernandez fails to teach the distal fixation feature 16 including a curvature that is shaped to match a profile of a medial epicondyle of the femur.
Tiongson’s plate is for use on a femur (abstract). The plate 100 at fig. 3 includes a distal fixation feature 146 which is “designed to reside or sit on the epicondyle”… (col. 8, lines 19-41). Tiongson’s portion 146 includes a plurality of fastener openings proximate the epicondyle 140a-h. The epicondyle can be seen to be a medial epicondyle as at fig. 1 (side 13).
It would have been obvious to one with ordinary skill in the art at the time of the invention to modify the Gonzalez-Hernandez fixation feature 16 to be of the configuration of the portion 146 of Tiongson. One would have done so in order to permit the surgeon to “key the bone plate into place on the condylar surface”; and “stabilize the bone plate over a bone”, etc. (col. 8, lines 30-41)
Regarding claim 32, the distal fixation feature 16 comprises one or more fingers 50 extending from the distal fixation feature, each finger comprising an opening 52/100 configured to receive a fastener. Examiner notes no structural distinction is required in the claim between the low-profile fixation feature and the fingers, such that the two elements 50 near the bottom end can be referred to as fixation features while the two elements 50 at the top end can be referred to as fingers.
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gonzalez-Hernandez in view of Tiongson and Fell et al. (US 8,728,133 B2)
Regarding claim 3, the low-profile fixation assembly 50 comprises an anchor opening 52/100 (seen in figs. 1 and 13; labeled in fig. 16A) that extends from the bone-facing surface and through the superior surface; and an anchor (fastener) configured to sit proximal to the superior surface. The fastener includes a head.
The combination fails to teach the head configured to sit proximal to the second side of the long bone when installed; and a tether having a distal end configured to engage with the anchor and a proximal end configured to engage with the head.
Fell teaches a kit as at fig. 19 including a bone plate 16 having an anchoring opening, therein, and an anchor 24 and a head 22 as arranged at fig. 9. The anchor and head are capable of sitting on both sides of a plate and both sides of a bone with installed. The anchor includes a tether 36 having a distal end capable of engaging the anchor 24 and a proximal end capable of engaging the head 22 as at fig. 9. It would have been obvious to one with ordinary skill in the art at the time of the invention to substitute the fastener design of Fell for the Screw of Gonzalez-Hernandez. One would have done so in order to provide a fastener which is more minimally invasive in nature and which does not protrude substantially from the far side of the bone when installed.
Claim(s) 15, 16, 27-29 and 33 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gonzalez-Hernandez in view of Tiongson and Feibel et al. (US 2007/0185493 A1).
Regarding claims 15 and 16, the combination suggests the limitations of claim 12, as above. Gonzalez Hernandez further demonstrates use of more than a single aperture 100/52 in the fixation assembly 50 as at fig. 16A.
However, Gonzalez Hernandez does not teach the first arm 50 being capable of extending over both the anterior side and a lateral side of the femur, the first arm comprising: an anterior fastener opening that extends through the first arm and over the anterior side; and a lateral fastener opening that extends through the first arm and over the lateral side.
Feibel teaches a bone plate including a low profile fixation assembly 3 (identified in fig. 1) in the version of fig. 7 including multiple screw holes therein which are capable of facing multiple sides of a bone about which 3 passes, including sides of the claimed arrangement. The fastener openings are offset relative to one another as seen in fig. 7.
It would have been obvious to one with ordinary skill in the art at the time of the invention to modify the Gonzalez-Hernandez fixation assembly 50 to extend further and be configured to attach to the claimed sides of the bone, in light of the Feibel teaching. One would have made such a modification to further ensure retention of the modified fixation assembly 50 to the bone, or to permit flexibility in area of attachment of the fastener to avoid a damaged portion of bone.
Regarding claims 27 and 33, Gonzalez-Hernandez teaches a bone plate system capable of use on a femur of a patient ([0003], [0010], [0045], claim 16), the bone plate system comprising a bone plate at fig.1 comprising:
a body 10 having a first end (down in fig. 1), a second end (up in fig. 1), a superior surface (out of the page) that is configured to face away from the femur, and a bone-facing surface (into the page) that is configured to face a first side of the femur when the bone plate is in use as in fig. 1, the femur comprising the first side (in contact with 10), a second side (into the page in fig. 1, back side of the bone), a third side (left in fig. 1), and a fourth side (right in fig. 1); and
a low-profile fixation assembly 50 configured to secure the first end (down) to the femur, the low-profile fixation assembly 50 capable of fixating the first end to the femur by approaching the first end from the second side and the third side (the two elements 50 at the bottom end approach on the second and third sides as in fig. 1);
wherein:
the bone plate is configured to approximate a shape of the femur ([0003], [0010], [0045], claim 16), see figs. 1-7;
the second end (up in fig. 1) comprises a distal fixation feature 16 configured to secure the second end to an epiphysis of the femur.
Gonzalez-Hernandez fails to teach 50 being capable of interacting with the second and third sides, as claimed; and fails to teach the distal fixation feature 16 including a curvature that is shaped to match a profile of the epiphysis of the femur.
However, it is noted that use of two screw holes 52/100 in 50 is taught as at fig. 16A.
Tiongson’s plate is for use on a femur (abstract). The plate 100 at fig. 3 includes a distal fixation feature 146 which is “designed to reside or sit on the epicondyle”… (col. 8, lines 19-41). Tiongson’s portion 146 includes a plurality of fastener openings proximate the epicondyle 140a-h. The epicondyle can be seen to be a medial epicondyle as at fig. 1 (side 13).
It would have been obvious to one with ordinary skill in the art at the time of the invention to modify the Gonzalez-Hernandez fixation feature 16 to be of the configuration of the portion 146 of Tiongson. One would have done so in order to permit the surgeon to “key the bone plate into place on the condylar surface”; and “stabilize the bone plate over a bone”, etc. (col. 8, lines 30-41)
The combination of Gonzalez-Hernandez and Tiongson continues to fail to teach 50 having the claimed structures.
Feibel teaches a bone plate including a low profile fixation assembly 3 (identified in fig. 1) in the version of fig. 7 including multiple screw holes therein which are capable of facing multiple sides of a bone about which 3 passes, including sides of the claimed arrangement.
It would have been obvious to one with ordinary skill in the art at the time of the invention to modify the Gonzalez-Hernandez fixation assembly 50 to extend further and be configured to attach to the claimed sides of the bone, in light of the Feibel teaching. One would have made such a modification to further ensure retention of the modified fixation assembly 50 to the bone, or to permit flexibility in area of attachment of the fastener to avoid a damaged portion of bone.
Regarding claim 33, the claim is considered to require essentially the same limitations as claim 27.
Regarding claim 28, the system includes a fastener 26/42 comprising external threads [0056-0057], the fastener configured to engage with the low-profile fixation assembly 50 to fixate the first end to the femur, wherein: the first fixation aperture 52/100 comprises first internal threads [0056-0057]; and the second fixation aperture 52/100 (as modified) comprises second internal threads [0056-0057].
Regarding claim 29, the body 10 is capable of extending along a medial side of the femur ([0003], [0010], [0045], claim 16).
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 David Bates whose telephone number is (571)270-7034. The examiner can normally be reached Monday through Friday, 10AM-6PM
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/DAVID W BATES/Primary Examiner, Art Unit 3799
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