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
This Office Action is responsive to the amendment filed November 7, 2025. As directed by the amendment: Claims 21, 26, and 36 have been amended. Claims 1-20, 38, and 40 have been cancelled. Claims 41 and 42 are newly added. Claims 21-37, 39, 41, and 42 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) 21-31, 34, and 35 is/are rejected under 35 U.S.C. 103 as being unpatentable over Baker (US 2016/0317205) in view of Kobayashi et al. (US 2015/0366597), herein referred to as Kobayashi.
Regarding claim 21, Baker discloses a bone plate (12) for fixing bone fragments to a bone (¶23), comprising a proximal bone plate portion (24) including a proximal longitudinal end (38) of the bone plate (12) and a distal bone plate portion (22) including a distal longitudinal end (36) of the bone plate (12), the bone plate (12) extending from the proximal longitudinal end (38) to the distal longitudinal end (36) in a longitudinal direction (figure 2), the proximal bone plate portion (24) being configured (i.e. capable of) to abut a bone fragment (¶23) and the distal bone plate portion (22) being configured to (i.e. capable of) abut a bone (¶23), the proximal bone plate portion (24) comprising a slotted positioning opening (60) having a length extension (la) substantially parallel to the longitudinal direction of the bone plate (12) (figure 2) and configured to (i.e. capable of) receive a rigid elongated positioning member (¶33), wherein the length extension (la) of the slotted positioning opening (60) in the longitudinal direction of the bone plate (12) is longer than a width extension (wa) of the slotted positioning opening (60) in a lateral direction (figure 2) perpendicular to the longitudinal direction (figure 2), wherein the width extension (wa) of the slotted positioning opening (60) substantially corresponds to a width extension of the elongated rigid positioning member (¶33) and is configured to (i.e. capable of) allow the elongated rigid positioning member to slide along (¶33) and in the slotted positioning opening (60).
Yet, Baker lacks the proximal bone plate portion comprising two fastening openings each configured to receive a respective fastening element for fastening the bone plate to at least one of the bone and the bone fragment, wherein the two fastening openings are positioned in the lateral direction relative to the slotted positioning opening on respective different sides of the slotted positioning opening, and wherein the two fastening openings comprise a locking structure configured to lock the respective fastening element at a selected angle to the bone plate, and wherein the bone plate comprises two further fastening openings positioned directly adjacent and below the slotted positioning opening closer to the distal end than the slotted positioning opening in the proximal bone plate portion, wherein the two further fastening openings comprise a locking structure configured to lock the respective fastening element at a selected angle to the bone plate.
However, Baker discloses various changes and modifications to the described embodiments described herein will be apparent to those skilled in the art, and such changes and modifications can be made without departing from the spirit and scope of the invention and without diminishing its intended advantage (¶42).
Furthermore, Kobayashi teaches a proximal bone plate portion (figures 5 and 6) comprising two fastening openings (212a, 212b) each configured to (i.e. capable of) receive a respective fastening element (114) for fastening the bone plate to at least one of the bone and the bone fragment (¶13), wherein the two fastening openings (212a, 212b) are positioned in a lateral direction relative to a slotted positioning opening (226) on respective different sides of the slotted positioning opening (226) (figures 5 and 6), and wherein the two fastening openings (212a, 212b) comprise a locking structure (¶12, ¶13) configured to (i.e. capable of) lock the respective fastening element at a selected angle to the bone plate, and wherein the bone plate (200) comprises two further fastening openings (212h, 212i) positioned directly adjacent and below the slotted positioning opening (226) closer to a distal end (figures 5 and 6) than the slotted positioning opening (226) in the proximal bone plate portion (figures 5 and 6), wherein the two further fastening openings (212h, 212i) comprise a locking structure (¶12, ¶13) configured to (i.e. capable of) lock the respective fastening element at a selected angle to the bone plate (¶12, ¶13).
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 Baker’s proximal bone plate portion with two fastening openings each configured to receive a respective fastening element for fastening the bone plate to at least one of the bone and the bone fragment, wherein the two fastening openings are positioned in the lateral direction relative to the slotted positioning opening on respective different sides of the slotted positioning opening, and wherein the two fastening openings comprise a locking structure configured to lock the respective fastening element at a selected angle to the bone plate, and wherein the bone plate comprises two further fastening openings positioned directly adjacent and below the slotted positioning opening closer to the distal end than the slotted positioning opening in the proximal bone plate portion, wherein the two further fastening openings comprise a locking structure configured to lock the respective fastening element at a selected angle to the bone plate as taught by Kobayashi, since such a modification is considered a change in design as Baker clearly contemplates various changes and modifications will be apparent to those skilled in the art.
Regarding claim 22, the modified Baker’s bone plate discloses all the features/elements as claimed but lacks a detailed description on wherein a maximum width extension of the slotted positioning opening amounts to approximately 1.0 to 3.0 mm.
However, the prior art of discovering optimum or workable ranges involves only routine experimentation in the art.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide the modified Baker’s bone plate with wherein a maximum width extension of the slotted positioning opening amounts to approximately 1.0 to 3.0 mm, since such a modification is considered optimization of the size of the prior art and patient/bone size dependent.
Regarding claim 23, the modified Baker's bone plate has wherein the slotted positioning opening (60 of Baker) is configured to (i.e. capable of) receive a K-Wire as the elongated positioning member (¶33 of Baker).
Regarding claim 24, the modified Baker’s bone plate has wherein the distal bone plate portion (22 of Baker) comprises an oblong opening (50 of Baker) configured to (i.e. capable of) receive a fastening member (32 of Baker) and having a length extension (ls of Baker) in the longitudinal direction of the bone plate (the modified Baker’s bone plate).
Regarding claim 25, the modified Baker's bone plate has wherein the width extension (wa of Baker) of the slotted positioning opening (60 of Baker) is smaller than a width extension (ws of Baker) of the oblong opening (50 of Baker) (figure 2 of Baker).
Regarding claim 26, the modified Baker’s bone plate has wherein the bone plate comprises at least one of one or more further fastening openings (elements 40 of Baker) positioned above the slotted positioning opening (60 of Baker) in the proximal bone plate portion (24 of Baker) closer to the proximal longitudinal end than the slotted positioning opening (60 of Baker), and further to the two further fastening openings positioned directly adjacent and below the slotted positioning opening, one or more further fastening openings (another element 40 of Baker) positioned below the slotted positioning opening (60 of Baker) closer to the distal end than the slotted positioning opening (60 of Baker) in at least one of the proximal bone plate portion and the distal bone plate portion (figure 2 of Baker).
Regarding claim 27, the modified Baker’s bone plate has wherein the one or more further fastening openings (another element 40 of Baker) positioned below the slotted positioning opening are positioned at at least one of the positions between the slotted positioning opening (60 of Baker) and an oblong opening (50 of Baker) in at least one of the distal bone plate portion (22 of Baker) and proximal bone plate portion, the oblong opening (50 of Baker) configured to (i.e. capable of) receive a fastening member (¶32 of Baker) and having a length extension in the longitudinal direction of the bone plate (figure 2 of Baker), and below the oblong opening (50 of Baker) closer to the distal end than the oblong opening (50 of Baker) in the distal bone plate portion (figure 2 of Baker).
Regarding claim 28, the modified Baker’s bone plate has wherein the distal bone plate portion (22 of Baker) does not comprise any fastening openings positioned in the lateral direction relative to the oblong opening (50 of Baker) and along the oblong opening (figure 2 of Baker).
Regarding claim 29, the modified Baker’s bone plate has wherein at least some of the further fastening openings (elements 40 of Baker) are locking openings (¶29 of Baker).
Regarding claim 30, the modified Baker's bone plate has wherein the proximal bone plate portion (the modified Baker’s proximal bone plate portion) comprises at least one of one or more K-Wire openings (68a, 68b of Baker) configured to (i.e. capable of) receive a K-Wire (¶36 of Baker) and positioned above the slotted positioning opening (60 of Baker) in the proximal bone plate portion (the modified Baker’s proximal bone plate portion) closer to the proximal longitudinal end (38 of Baker) than the slotted positioning opening (60 of Baker), and one or more K-Wire openings (54 of Baker) configured to (i.e. capable of) receive a K-Wire (¶32 of Baker) and positioned below the slotted positioning opening (60 of Baker) closer to the distal end (36 of Baker) than the slotted positioning opening (60 of Baker).
Regarding claim 31, the modified Baker's bone plate has wherein one or more of the one or more K-Wire openings (68a, 68b, 54 of Baker) are configured to (i.e. capable of) receive a pin of a targeting device (considered functional) adapted to (i.e. capable of) insert the fastening members into the bone plate for preventing a rotation of the bone plate relative to the targeting device.
Regarding claim 34, the modified Baker's bone plate has wherein the proximal bone plate portion (the modified Baker’s proximal bone plate portion) has a width extension (figure 2 of Baker) that is greater than the width extension of the distal bone plate portion (22 of Baker) (figure 2 of Baker).
Regarding claim 35, the modified Baker’s bone plate has wherein the proximal bone plate portion (the modified Baker’s proximal bone plate portion) and the distal bone plate portion (22 of Baker) adjoin each other (figure 2 of Baker).
Claim(s) 32, 33, 36, 37, 41, and 42 is/are rejected under 35 U.S.C. 103 as being unpatentable over Baker (US 2016/0317205) in view of Kobayashi (US 2015/0366597) and further in view of Huebner et al. (US 2005/0240187), herein referred to as Huebner.
Regarding claim 32, the modified Baker's bone plate discloses all the features/elements as claimed but lacks wherein the bone plate is a proximal humeral bone plate, the proximal bone plate portion is configured to abut a humeral portion in a region of a greater tuberosity, and the distal bone plate portion is configured to abut a humeral shaft portion. However, Baker discloses the bone plate may be configured for use in association with other orthopedic surgeries or procedures associated with other bones or joints requiring fixation in addition to the distal radius bone (¶23).
In addition, Huebner teaches bone plates may be configured for use on any suitable bone such as radius, a humerus, or any other suitable bones (¶21).
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 the modified Baker’s bone plate to be a proximal humeral bone plate as taught by Huebner, since such a modification would provide an alternative use for fixation of the humeral bone as Baker clearly contemplates using the bone plate with other bones.
Thus, the modified Baker’s bone plate has the proximal bone plate portion (the modified Baker’s proximal bone plate portion) is configured to (i.e. capable of) abut a humeral portion in a region of a greater tuberosity (¶65 of Huebner), and the distal bone plate portion (22 of Baker) is configured to (i.e. capable of) abut a humeral shaft portion (¶65 of Huebner).
Regarding claim 33, the modified Baker’s bone plate has wherein the slotted positioning opening (60 of Baker) is positioned so that a K-Wire (¶33 of Baker) inserted in the slotted positioning hole (60 of Baker) extends in or close to a calcar region of the humerus (¶65 of Huebner).
Regarding claim 36, Baker discloses a bone plate (12), comprising a proximal bone plate portion (24) including a proximal longitudinal end (38) of the bone plate (12) and a distal bone plate portion (22) including a distal longitudinal end (36) of the bone plate (12), the bone plate (12) extending from the proximal longitudinal end (38) to the distal longitudinal end (36) in a longitudinal direction (figure 2), the proximal bone plate portion (24) being configured (i.e. capable of) to abut a bone fragment (¶23) and the distal bone plate portion (22) being configured to (i.e. capable of) abut a bone (¶23), the proximal bone plate portion (24) comprises a slotted positioning opening (60) configured and positioned to (i.e. capable of) receive a K-wire (¶33) (the Examiner notes that the K-wire has not been positively claimed), wherein the slotted positioning opening (60) has a length extension (la) substantially parallel to the longitudinal direction of the bone plate (figure 2) that is longer than a width extension (wa) in a lateral direction (figure 2) perpendicular to the longitudinal direction (figure 2).
Yet, Baker lacks the proximal bone plate portion comprises two fastening openings each configured to receive a respective fastening element for fastening the bone plate to at least one of the bone and the bone fragment, wherein the two fastening openings are positioned in the lateral direction relative to the slotted positioning opening on respective different sides of the slotted positioning opening, the proximal bone plate portion comprises two or more further fastening openings, and wherein the two or more further fastening openings are positioned in the proximal bone plate portion directly below the slotted positioning opening closer to the distal end than the slotted positioning opening.
However, Baker discloses various changes and modifications to the described embodiments described herein will be apparent to those skilled in the art, and such changes and modifications can be made without departing from the spirit and scope of the invention and without diminishing its intended advantage (¶42).
Furthermore, Kobayashi teaches a proximal bone plate portion (figures 5 and 6) comprising two fastening openings (212a, 212b) each configured to (i.e. capable of) receive a respective fastening element (114) for fastening the bone plate to at least one of the bone and the bone fragment (¶13), wherein the two fastening openings (212a, 212b) are positioned in a lateral direction relative to a slotted positioning opening (226) on respective different sides of the slotted positioning opening (226) (figures 5 and 6), the proximal bone plate portion (figures 5 and 6) comprises two or more further fastening openings (212h, 212i), and wherein the two or more further fastening openings (212h, 212i) are positioned in the proximal bone plate portion (figures 5 and 6) directly below the slotted positioning opening (226) closer to a distal end than the slotted positioning opening (226) (figures 5 and 6).
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 Baker’s proximal bone plate portion with two fastening openings each configured to receive a respective fastening element for fastening the bone plate to at least one of the bone and the bone fragment, wherein the two fastening openings are positioned in the lateral direction relative to the slotted positioning opening on respective different sides of the slotted positioning opening, the proximal bone plate portion comprises two or more further fastening openings, and wherein the two or more further fastening openings are positioned in the proximal bone plate portion directly below the slotted positioning opening closer to the distal end than the slotted positioning opening as taught by Kobayashi, since such a modification is considered a change in design as Baker clearly contemplates various changes and modifications will be apparent to those skilled in the art.
The modified Baker’s bone plate further lacks wherein the bone plate is a proximal humeral bone plate. However, Baker discloses the bone plate may be configured for use in association with other orthopedic surgeries or procedures associated with other bones or joints requiring fixation in addition to the distal radius bone (¶23).
In addition, Huebner teaches bone plates may be configured for use on any suitable bone such as radius, a humerus, or any other suitable bones (¶21).
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 Baker’s bone plate to be a proximal humeral bone plate as taught by Huebner, since such a modification would provide an alternative use for fixation of the humeral bone as Baker clearly contemplates using the bone plate with other bones.
Thus, the modified Baker’s bone plate has the proximal bone plate portion (the modified Baker’s proximal plate portion) being configured to (i.e. capable of) abut a humeral portion in a region of a greater tuberosity (¶65 of Huebner) and the distal bone plate portion (22 of Baker) being configured to (i.e. capable of) abut a humeral shaft portion (¶65 of Huebner), the proximal bone plate portion (the modified Baker’s proximal plate portion) comprises a slotted positioning opening (60 of Baker) configured and positioned to (i.e. capable of) receive a K-wire (¶33 of Baker), which, in a received state, extends in or close to a calcar region of a humerus (figure 1 of Huebner), such that the two or more calcar screws (e.g. fixation elements), when inserted into the two or more further fastening openings (212h, 212i of Kobayashi) with the proximal humeral bone plate positioned on the humerus, protrude into the calcar region of the humerus (figure 1 of Huebner).
Regarding claim 37, the modified Baker’s bone plate discloses all the features/elements as claimed but lacks a detailed description on wherein a maximum width extension of the slotted positioning opening amounts to approximately 1.0 to 3.0 mm.
However, the prior art of discovering optimum or workable ranges involves only routine experimentation in the art.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide the modified Baker’s bone plate with wherein a maximum width extension of the slotted positioning opening amounts to approximately 1.0 to 3.0 mm, since such a modification is considered optimization of the size of the prior art and patient/bone size dependent.
Regarding claim 41, the modified Baker’s bone plate has wherein the slotted positioning opening (60 of Baker) is positioned in the proximal bone plate portion (the modified Baker’s proximal plate portion) such that, in the received state of the K-wire (¶33 of Baker) and the proximal bone plate portion (the modified Baker’s proximal plate portion) abutting on the humeral portion in the region of the greater tuberosity (¶65 of Huebner), the K-wire (¶33 of Baker) extends in or close to a calcar region of the humerus (figure 1 of Huebner).
Regarding claim 42, the modified Baker’s bone plate has wherein the two or more calcar screws (e.g. fixation elements), when inserted into the two or more further fastening openings (212h, 212i of Kobayashi) with the proximal humeral bone plate positioned on the humeral portion in the region of the greater tuberosity (¶65 of Huebner) and the K-wire (¶33 of Baker) extending in or close to the calcar region of the humerus (figure 1 of Huebner), protrude into the calcar region of the humerus (figure 1 of Huebner).
Claim(s) 39 is/are rejected under 35 U.S.C. 103 as being unpatentable over Baker (US 2016/0317205) in view of Huebner (US 2005/0240187).
Regarding claim 39, Baker discloses a method of positioning a bone plate (12) on a distal radius bone (Abstract) and inserting a K-Wire (¶33) into a slotted opening (60) provided in a proximal bone plate portion (24) (figure 2).
Yet, Baker lacks the method for positioning a bone plate on a humerus (e.g. humeral bone plate). However, Baker discloses the bone plate may be configured for use in association with other orthopedic surgeries or procedures associated with other bones or joints requiring fixation in addition to the distal radius bone (¶23).
In addition, Huebner teaches bone plates may be configured for use on any suitable bone such as radius, a humerus, or any other suitable bones (¶21).
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 Baker’s method of positioning a bone plate on a distal radius with a method of positioning a bone plate on a humerus (e.g. humeral bone plate) as taught by Huebner, since such a modification would provide an alternative use for fixation of the humeral bone as Baker clearly contemplates using the bone plate with other bones.
Thus, the modified Baker’s method has a method of adjusting a position of a humeral bone plate (via surgeon), the method comprising positioning a bone plate (12 of Baker) on a humerus (figure 1 of Huebner) so that a proximal bone plate portion (24 of Baker) abuts a humeral portion in a region of a greater tuberosity (figure 3 of Huebner) and a distal bone plate portion (22 of Baker) abuts a humeral shaft portion (figures 1 and 3 of Huebner), inserting a K-Wire (¶33 of Baker) into a slotted positioning opening (60 of Baker) provided in the proximal bone plate portion (24 of Baker) so that the K-Wire (¶33 of Baker) extends into a calcar region of the humerus or is positioned close to the calcar region of the humerus (figures 1 and 3 of Huebner), verifying whether the K-Wire (¶33 of Baker) is correctly positioned in the calcar region or close to the calcar region (figures 1 and 3 of Huebner) (via surgeon), if it is determined that the K-Wire (¶33 of Baker) is not correctly positioned (via surgeon), moving the bone plate (12 of Baker) in a longitudinal direction of the bone plate with the K-Wire (¶33 of Baker) gliding in the slotted positioning opening (60 of Baker) for adjusting the bone plate position, and if it is determined that the K-Wire (¶33 of Baker) is correctly positioned (via surgeon), inserting two or more calcar screws (elements 150 of Huebner) into respective two or more fastening openings (elements 152 of Huebner) provided in the proximal bone plate portion (24 of Baker) so as to protrude into the calcar region of the humerus (figure 1 of Huebner).
Response to Arguments
Applicant's arguments filed November 7, 2025 have been fully considered but they are not persuasive.
Applicant’s arguments on pages 7-12, under 35 U.S.C. 103, of the Remarks are directed to the amended claims and the combination of references (Baker, Huebner, Raven). Applicant argues the amended feature of “wherein the slotted positioning opening has a length extension substantially parallel to the longitudinal direction of the bone plate" and "the proximal bone plate portion comprises two fastening openings configured to receive a respective fastening element for fastening the bone plate to the humerus, wherein the two fastening openings are positioned in the lateral direction relative to the slotted positioning opening on respective different sides of the slotted positioning opening”. Thus, the Examiner has relied upon the reference Kobayashi to teach applicant’s amended features, see Office Action above.
In response to applicant's argument that Baker is intended for treatment of a distal radius bone, 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. Lastly, Baker discloses the bone plate may be configured for use in association with other orthopedic surgeries or procedures associated with other bones or joints requiring fixation in addition to the distal radius bone (¶23). Thus, Baker does not preclude the bone plate from being used on a humerus.
Conclusion
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/SI MING KU/Primary Examiner, Art Unit 3775