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 12, 2025. As directed by the amendment: Claims 1, 3, 6, 10, 12, and 13 have been amended. Claims 2, 7, 9, and 15-20 have been cancelled. Claims 21-29 are newly added. Claims 1, 3-6, 8, 10-14, and 21-29 are presently pending in this application.
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 24 and 25 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 24 and 25 recites the limitation "the distinct bridge portion" in ll. 1. There is insufficient antecedent basis for this limitation in these claims.
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 § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1 and 3-5 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Waizenegger et al. (US 11,071,571), herein referred to as Waizenegger.
Regarding claim 1, Waizenegger discloses a surgical fixation device (1) (figures 8-10), the device comprising a first brace portion (3) including a first end (figures 8-10), a second end (figures 8-10) formed opposite the first end (figures 8-10), and a first plurality of openings (elements 8) formed through the first brace portion (3), the first plurality of openings (elements 8) extending between the first end (figures 8-10) and the second end (figures 8-10) of the first brace portion (3), a second brace portion (another element 3) positioned opposite the first brace portion (3), the second brace portion (another element 3) including a first end (figures 8-10), a second end (figures 8-10) formed opposite the first end (figures 8-10), and a second plurality of openings (another elements 8) formed through the second brace portion (another element 3), the second plurality of openings (another elements 8) extending between the first end (figures 8-10) and the second end (figures 8-10) of the second brace portion (another element 3), and a bridge portion (4) extending between the first brace portion (3) and the second brace portion (another element 3), the bridge portion (4) including at least one hole (6) formed therethrough, wherein the bridge portion (4) including a first segment (portion of element 4) formed monolithic (col. 5, ll. 27-35 and figures 8-10) with the first brace portion (3), the first segment (portion of element 4) extending away from the first brace portion (3), and the first segment (portion of element 4) including at least one hole (6) formed therethrough (figure 10), and a second segment (another portion of element 4) formed monolithic (col. 5, ll. 27-35 and figures 8-10) with the second brace portion (another element 3), the second segment (another portion of element 4) extending away from the second brace portion (another element 3) and toward the first segment (portion of element 4), the second segment (another portion of element 4) including at least one hole (another element 6) formed therethrough (figures 8-10), the at least one hole (another element 6) of the second segment (another portion of element 4) substantially aligned with the at least one hole (6) of the first segment (portion of element 4) to couple the second segment (another portion of element 4) and the first segment (portion of element 4) of the bridge portion (4).
Regarding claim 3, Waizenegger discloses wherein the at least one hole of the first segment (portion of element 4) includes a first plurality of holes (elements 6) and the at least one hole of the second segment (another portion of element 4) includes a second plurality of holes (another elements 6).
Regarding claim 4, Waizenegger discloses further comprising a distinct bridge portion (another element 4) extending between the first brace portion (3) (figure 10) and the second brace portion (another element 3) (figure 10), adjacent to and separated from the bridge portion (4) (figure 10).
Regarding claim 5, Waizenegger discloses wherein the distinct bridge portion (another element 4) includes at least one hole (6) formed therethrough (figure 10).
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) 6 and 26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Waizenegger (US 11,071,571) in view of Conley et al. (US 2014/0052176), herein referred to as Conley.
Regarding claims 6, 26, Waizenegger’s surgical fixation device discloses all the features/elements as claimed but lacks further comprising a securing component configured to secure the surgical fixation device to a patient's bone, wherein the at least one hole of the first segment and the at least one hole of the second segment are aligned to receive the securing component.
However, Conley teaches a securing component (10) configured to (i.e. capable of) secure a surgical fixation device (12) to a patient's bone.
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 Waizenegger’s surgical fixation device with a securing component configured to secure the surgical fixation device to a patient's bone as taught by Conley, since such a modification would enable placement of one or more sutures according to the needs of the surgeon at the time of placement of the plate (¶28).
Thus, the modified Waizenegger’s surgical fixation device has wherein the at least one hole (6 of Waizenegger) of the first segment (portion of element 4 of Waizenegger) and the at least one hole (another element 6 of Waizenegger) of the second segment (another portion of element 4 of Waizenegger) are aligned to receive the securing component (10 of Conley).
Claim(s) 8 and 22-25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Waizenegger (US 11,071,571).
Regarding claim 8, Waizenegger’s surgical fixation device discloses all the features/elements as claimed but lacks wherein the first segment of the bridge portion is releasably coupled to the second segment.
However, it is known that constructing a formerly integral structure in various elements involves routine skill 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 modify Waizenegger’s surgical fixation device with wherein the first segment of the bridge portion is releasably coupled to the second segment, since it is known that constructing a formerly integral structure in various elements involves routine skill in the art and further capable of being removed.
Regarding claim 22, Waizenegger discloses a surgical fixation device (1) (figures 8-10), the device (1) comprising a first brace portion (3) (figures 8-10) including a first end (figures 8-10), a second end (figures 8-10) formed opposite the first end (figures 8-10), and a first plurality of openings (elements 8) formed through the first brace portion (3), the first plurality of openings (elements 8) extending between the first end (figures 8-10) and the second end (figures 8-10) of the first brace portion (3), a second brace portion (another element 3) positioned opposite the first brace portion (3) (figures 8-10), the second brace portion (another element 3) including a first end (figures 8-10), a second end (figures 8-10) formed opposite the first end (figures 8-10), and a second plurality of openings (another elements 8) formed through the second brace portion (another element 3), the second plurality of openings (another elements 8) extending between the first end (figures 8-10) and the second end (figures 8-10) of the second brace portion (another element 3), and a bridge portion (4) extending between the first brace portion (3) and the second brace portion (another element 3) (figures 8-10), the bridge portion (4) including at least one hole (6) formed therethrough (figures 8-10), wherein the bridge portion (4) including a first segment (portion of element 4) formed monolithic (col. 5, ll. 27-35 and figures 8-10) with the first brace portion (3), the first segment (portion of element 4) extending away from the first brace portion (3), and the first segment (portion of element 4) including a first plurality of holes (elements 6) formed therethrough (figures 8-10), and a second segment (another portion of element 4) formed monolithic (col. 5, ll. 27-35 and figures 8-10) with the second brace portion (another element 3), the second segment (another portion of element 4) extending away from the second brace portion (another element 3) and toward the first segment (portion of element 4), the second segment (another portion of element 4) including a second plurality of holes (another elements 6) formed therethrough, the second plurality of holes (another elements 6) substantially aligned with the first plurality of holes (elements 6) of the first segment (portion of element 4).
Yet, Waizenegger lacks the second plurality of holes substantially aligned with the first plurality of holes of the first segment to releasably couple the second segment and the first segment of the bridge portion.
However, it is known that constructing a formerly integral structure in various elements involves routine skill 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 modify Waizenegger’s surgical fixation device with the first segment to releasably couple the second segment and the first segment of the bridge portion, since it is known that constructing a formerly integral structure in various elements involves routine skill in the art and further capable of being removed.
Regarding claim 23, the modified Waizenegger’s surgical fixation device has wherein the at least one hole of the first segment bridge portion (portion of element 4) includes a first plurality of holes (elements 6), and the at least one hole of the second segment (another portion of element 4) includes a second plurality of holes (another elements 6) formed through the bridge portion (figure 10).
Regarding claim 24, the modified Waizenegger’s surgical fixation device has wherein the distinct bridge portion (another element 4) extending between the first brace portion (3) and the second brace portion (another element 3), adjacent to and separated from the bridge portion (4) (figures 8-10).
Regarding claim 25, the modified Waizenegger’s surgical fixation device has wherein the distinct bridge portion (another element 4) includes at least one hole (6) formed therethrough (figure 10).
Allowable Subject Matter
Claims 10-12, 21, and 27-29 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.
Claims 13 and 14 are allowed.
The following is a statement of reasons for the indication of allowable subject matter: After further search and consideration it is determined that the prior art of record neither anticipated nor renders obvious the claimed subject matter of the instant application as a whole either taken alone or in combination, in particular, the prior art of record does not teach, the following limitation(s) in combination with the remaining claimed limitation such as but not limited to “wherein the placing of the device such that the first brace portion and the second brace portion of the device are placed on either side of the osteotomy fragment; securing the device to the tibia; and passing sutures through the first plurality of openings and the second plurality of openings to thereby secure the osteotomy fragment to the tibia”.
Response to Arguments
Applicant's arguments filed December 12, 2025 have been fully considered. Applicant’s arguments with respect to the reference Chen has been considered but are moot because the new ground of rejection does not rely on this reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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