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 December 18, 2025. As directed by the amendment: Claims 1, 12, and 13 have been amended. Claims 10, 11, and 16-20 were withdrawn. Claims 1-20 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) 1-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zingalis et al. (US 2021/0106368), herein referred to as Zingalis, and in view of Laird, JR. et al. (US 2019/0269443), herein referred to as Laid, and further in view of Tiongson et al. (US 10,856,920), herein referred to as Tiongson.
Regarding claim 1, Zingalis discloses a plate (100) configured to (i.e. capable of) support an ulna (figures 1 and 2), the plate (100) extending longitudinally to define a proximal end (102) and a distal end (104) opposite the proximal end (102) (figures 1 and 2), the plate (100) comprising a first surface (116) and a second surface (114) opposite the first surface (116) (figure 1), wherein at least a portion of the first surface (116) is configured to (i.e. capable of) contact a surface of the ulna (2) (figure 1), first openings (elements 130) spaced apart from one another longitudinally along a shaft portion (110) of the plate (100) that corresponds to at least one of a proximal metaphysis or a diaphysis of the ulna (2) (figure 1), second openings (e.g. 134, 136, 138, 140, 142, 144, ¶36) spaced apart from one another along a proximal portion (112) of the plate (100) that corresponds to at least one of the proximal metaphysis or a proximal epiphysis of the ulna (2) (figure 1), wherein the first openings and the second openings (e.g. 130, 134, 136, 138, 140, 142, 144, ¶36) each define a fastener insertion axis (figures 1, 2, 4-7) for a fastener (50) to be inserted therethrough (¶36), wherein at least some of the second openings (e.g. 134, 144) define the fastener insertion axis (figures 4-7) to be generally normal (¶48) to the second surface (114) of the plate (100), and apertures (elements 132) each adjacent to at least one of the first openings (130) or the second openings (e.g. 134, 136, 138, 140, 142, 144), each of the apertures (elements 132) defining a stabilizer insertion axis (figure 2) for a stabilizer (e.g. k-wire, ¶47) to be inserted therethrough, wherein the stabilizer insertion axis (figure 2) is generally parallel with the fastener insertion axis (¶47) of the at least one of the first openings (130) or the second openings (e.g. 134, 136, 138, 140, 142, or 144) to which each of the apertures is adjacent (figure 2), wherein the first surface (116) of the plate (100) is contoured to wrap around an olecranon of the ulna (figure 1), an oblong profile opening (146) in the proximal portion (considered as the portion near element 102, see figure 2).
Yet, Zingalis lacks a detailed description on wherein a diameter of each of the first openings is larger than a diameter of each of the second openings.
However, Laird teaches a diameter of each of the first openings (elements 140) (e.g. 3.5 mm in diameter, ¶81) is larger than a diameter of each of the second openings (elements 120 or 121) (e.g. 2.5 mm in diameter, ¶81).
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 Zingalis’s plate with wherein a diameter of each of the first openings is larger than a diameter of each of the second openings as taught by Laird, since such a modification is considered a change in size that is generally recognized as being within the level of ordinary skill in the art.
The modified Zingalis’s plate further lacks at least two oblong profile openings in the distal portion with each disposed between two second openings. Yet, Zingalis teaches in some embodiments, there could be additional positioning slots (oblong profile openings) (¶64).
Furthermore, Tiongson teaches at least two oblong profile openings (232a, 232b) (figure 4) in a distal portion (210) with each disposed between two second openings (e.g. 230a-230j) (figure 4).
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 Zingalis’s plate with at least two oblong profile openings in the distal portion with each disposed between two second openings as taught by Tiongson, since such a modification would allow for compression along the shaft portion of the bone (col. 9, ll. 47-65).
Thus, the modified Zingalis’s plate has wherein each of the oblong profile openings in the proximal (146 of Zingalis) and distal portions (232a, 232b of Tiongson) is configured to (i.e. capable of) receive a corresponding fastener at longitudinal locations along the length of the oblong profile.
Regarding claim 2, the modified Zingalis’s plate has wherein at least some of the first openings (elements 130 of Zingalis) and the second openings (e.g. 134, 136, 138, 140, 142, 144, ¶36 of Zingalis) include locking features (¶39-¶40 of Zingalis) configured to (i.e. capable of) prevent respective fasteners from loosening after being inserted therethrough.
Regarding claim 3, the modified Zingalis’s plate has wherein the fastener insertion axis of each of the first openings (elements 130 of Zingalis) and the second openings (e.g. 134, 136, 138, 140, 142, 144, ¶36 of Zingalis) include a nominal fastener insertion axis (¶48 of Zingalis) and a conical range of fastener insertion axes (figures 2 and 6 of Zingalis) (¶43 of Zingalis) surrounding the nominal fastener insertion axis (¶57 of Zingalis), and wherein the stabilizer insertion axis (figure 2 of Zingalis) is generally parallel with the nominal fastener insertion axis (figures 1 and 2 of Zingalis) of the at least one of the first openings (elements 130 of Zingalis) or the second openings to which each of the apertures (elements 132 of Zingalis) is adjacent.
Regarding claim 4, the modified Zingalis’s plate has wherein each of the first openings (elements 130 of Zingalis) and the second openings (e.g. 134, 136, 138, 140, 142, 144, ¶36 of Zingalis) defines the nominal fastener insertion axis (figures 4-7 of Zingalis) to not intersect with the nominal fastener insertion axis of any other of the first openings (elements 130 of Zingalis) and the second openings (e.g. 134, 136, 138, 140, 142, 144, ¶36 of Zingalis).
Regarding claim 5, the modified Zingalis’s plate discloses all the features/elements as claimed but lacks a detailed description on wherein the second surface of the plate is beveled at the distal end of the plate.
However, Laird teaches a second surface of the plate (102) is beveled (¶76) at the distal end (111) of the plate (102).
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 Zingalis’s plate with wherein the second surface of the plate is beveled at the distal end of the plate as taught by Laird, since such a modification allows for simplified submuscular plate insertion to minimize incision length (¶76).
Regarding claim 6, the modified Zingalis’s plate has wherein at least one of the second openings (e.g. 134, 136, 138, 140, 142, 144, ¶36 of Zingalis) defines the nominal fastener insertion axis (figures 1 and 4-7 of Zingalis) to target a coronoid (8 of Zingalis), a proximal region of the olecranon (6 of Zingalis), or an intermedullary canal of the ulna (2 of Zingalis) from a posterior surface of the olecranon of the ulna (2 of Zingalis).
Regarding claim 7, the modified Zingalis’s plate has wherein a thickness of the proximal portion of the plate (100 of Zingalis) is tapered (figure 7 of Zingalis) such that the proximal end (102 of Zingalis) of the plate (100 of Zingalis) is thinner than the shaft portion (110 of Zingalis) (figure 7 of Zingalis).
Regarding claim 8, the modified Zingalis’s plate has wherein the proximal portion (112 of Zingalis) includes side that are arcuately curved (figures 2 and 6 of Zingalis) to form one or more bulbus regions (figures 2 and 6 of Zingalis).
Regarding claim 9, the modified Zingalis’s plate has wherein two of the second openings (figures 4-7 of Zingalis) of the proximal portion (112 of Zingalis) are positioned laterally adjacent to one another at the proximal end of the plate (100 of Zingalis), and wherein the two of the second openings (figures 4-7 of Zingalis) each define the nominal fastener insertion axis (figures 4-7 of Zingalis) to aim generally distally along a longitudinal axis of the ulna (2 of Zingalis) toward a diaphysis of the ulna (figure 1 of Zingalis).
Claim(s) 12-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zingalis (US 2021/0106368) in view of Tiongson (US 10,856,920).
Regarding claim 12, Zingalis discloses a plate (100) configured to (i.e. capable of) support an ulna (2) (figures 1 and 2), the plate (100) extending longitudinally to define a proximal end (102) and a distal end (104) opposite the proximal end (102) (figures 1 and 2), the plate (100) comprising a first surface (116) and a second surface (114) opposite the first surface (116) (figure 1), wherein at least a portion of the first surface (116) is configured to (i.e. capable of) contact a surface of the ulna (2) (figure 1), openings (e.g. 130, 134, 136, 138, 140, 142, 144, ¶36) spaced apart from one another along the plate (100) (figure 2), at least some of the openings defining a nominal fastener insertion axis (figures 1 and 4-7) and a conical range of fastener insertion axes (¶43 and figures 2 and 6) surrounding the nominal fastener insertion axis for a fastener (¶43) to be inserted therethrough (figures 1 and 4-7), and apertures (elements 132) each adjacent to at least one of the openings (e.g. 130, 134, 136, 138, 140, 142, 144, ¶36), each of the apertures (elements 132) defining a stabilizer insertion axis (figure 2) for a stabilizer (e.g. k-wire, ¶47) to be inserted therethrough, wherein the stabilizer insertion axis (figure 2) is generally parallel with the nominal fastener insertion axis (figures 1 and 2) of the at least one of the openings (e.g. 130) to which each of the apertures (elements 132) is adjacent, wherein the first surface (116) of the plate (100) is contoured to wrap around an olecranon of the ulna (2) (figure 1), an oblong profile opening (146) in a proximal portion of the plate (considered as the portion near element 102, see figure 2).
Yet, Zingalis lacks at least two oblong profile openings in the distal portion with each disposed between two second openings. However, Zingalis teaches in some embodiments, there could be additional positioning slots (oblong profile openings) (¶64).
Furthermore, Tiongson teaches at least two oblong profile openings (232a, 232b) (figure 4) in a distal portion (210) with each disposed between two second openings (e.g. 230a-230j) (figure 4).
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 Zingalis’s plate with at least two oblong profile openings in the distal portion with each disposed between two second openings as taught by Tiongson, since such a modification would allow for compression along the shaft portion of the bone (col. 9, ll. 47-65).
Thus, the modified Zingalis’s plate has wherein each of the oblong profile openings in the proximal (146 of Zingalis) and distal portions (232a, 232b of Tiongson) is configured to (i.e. capable of) receive a corresponding fastener at longitudinal locations along the length of the oblong profile.
Regarding claim 13, the modified Zingalis’s plate has wherein at least one of the oblong profile openings (146 of Zingalis) includes ramped surfaces on each end thereof (figure 13 of Zingalis) to support dynamic compression of the ulna (2 of Zingalis).
Regarding claim 14, the modified Zingalis’s plate discloses all the features/elements as claimed but lacks wherein the second surface of the plate is beveled at the distal end of the plate.
However, Tiongson teaches wherein a second surface (220) of a plate (200) is beveled (col. 9, ll. 11-16 and figure 4) at a distal end of the plate (200) (figure 4).
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 Zingalis’s plate with wherein the second surface of the plate is beveled at the distal end of the plate as taught by Tiongson, since such a modification serves as the lead portion of the bone plate to enter into an incision (col. 9, ll. 11-16).
Regarding claim 15, the modified Zingalis’s plate has wherein some of the openings (e.g. 130, 134, 136, 138, 140, 142, 144, 146, ¶36 of Zingalis) define the nominal fastener insertion axis (figures 1, 2, 4-7 of Zingalis) to be substantially normal to the second surface of the plate (the modified Zingalis’s plate), and wherein some of the openings (e.g. 130, 134, 136, 138, 140, 142, 144, 146, ¶36 of Zingalis) define the nominal fastener insertion axis to target a coronoid (8 of Zingalis), a proximal region of the olecranon (6 of Zingalis), or an intermedullary canal of the ulna (2 of Zingalis) (figures 1 and 4-7 of Zingalis).
Response to Arguments
Applicant's arguments filed December 18, 2025 have been fully considered but they are not persuasive.
Applicant’s arguments on page 7, under 35 U.S.C. 102(a)(1) and 35 U.S.C. 103, of the Remarks are directed to the amended claims 1 and 12. Applicant argues that the amended claims do not teach the feature of “an oblong profile opening in the proximal portion; and at least two oblong profile openings in the distal portion with each disposed between two second openings, wherein each of the oblong profile openings in the proximal and distal portions is configured to receive a corresponding fastener at longitudinal locations along the length of the oblong profile”. Thus, the Examiner has relied upon the combination of references (Zingalis and Tiongson) to teach applicant’s amended features, see Office Action above.
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.
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/SI MING KU/Primary Examiner, Art Unit 3775