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 . This action is in response to Request for Continued Examination received on September 03, 2026. Claims 1-20 are currently pending.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on September 3, 2026 has been entered.
Claim Rejections - 35 USC § 103
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.
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.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-8 are rejected under 35 U.S.C. 103 as being unpatentable over US Huebner et al. (US Publication 2014/0163621), hereinafter “Huebner” in view Erikson et al. (US Publication 2007/0270851), hereinafter “Erikson” and further in view of Whitaker et al. (US Publication 2018/0177510), hereinafter “Whitaker”.
Regarding claim 1, Huebner discloses a bone plate alignment template (250, Figure 6) capable of placement on a bone, comprising: an at least radiolucent main body [paragraphs 34-36 describe a radiolucent guide body]; including a bone-facing lower surface (274, Figure 6), an upper surface (272, Figure 6) opposite the lower surface; and a radiopaque outer portion around the main body [paragraphs 34-36 describe a radiopaque portion to contrast with the radiolucent portion].
Huebner fails to disclose wherein the radiopaque outer portion extends on and around an outer rim; and a cavity extending inwardly from the lower surface towards the upper surface, wherein the cavity is configured to receive an outer portion of a bone plate
Erikson, however, teaches a radiopaque portion (70, Figure 2) disposed about a periphery (68, Figure 2) of the main body (30, Figure 2).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time the invention was made to modify the template of Huebner wherein the radiopaque outer portion extends on and around an outer rim as taught by Erikson in order to have a portion that can be distinguished from another portion in a radiograph.
Whitaker teaches a plate receiving cavity and space. Whitaker discloses a guide body (106, Figure 6) having an upper/first guide surface (110, Figure 7) and an opposing bone-facing lower guide surface (112, Figure 7); paired leg portions (118a and 118b, Figure 7) extending from the lower surface; facing inner surfaces (128, Figure 7) and lateral extensions (140, Figure 7) defining a cavity or plate receiving space extending inwardly from the lower side of the guide toward the upper surface, the space being configured to receive an outer portion of bone plate (20, Figures 3 and 5) The gap is created between opening 132 and side surfaces 140, as best seen in Figure 7.
Therefore, it would have been obvious to a person having ordinary skill in the art at the time the invention was made to modify the lower plate engaging portion of Huebner and Erikson’s guide block with a plate receiving attachment arrangement of Whitaker to provide secure and properly aligned coupling between the guide and bone plate while allowing the guide and plate to be positioned together.
Regarding claim 2, the modified Huebner’s bone plate discloses further comprising: distal and proximal ends (see the diagram below); and a central opening (270, Figure 7) within the main body, the central opening extending across a majority of a length and a majority of a width of the distal end.
Regarding claim 3, the modified Huebner’s bone plate discloses wherein the distal end defines a generally fan-shaped portion (see the diagram below of Huebner) and includes an extension portion (see the diagram below of Huebner) extending distally from one side of the fan-shaped portion.
Regarding claim 4, the modified Huebner’s bone plate discloses further comprising a distal hole (267, Figure 6 of Huebner) extending through the main body (see the diagram below of Huebner), wherein the distal hole is between the extension portion and the central opening.
Regarding claim 5, the modified Huebner’s bone plate discloses wherein the distal hole is an oblong hole (see the diagram below of Huebner).
Regarding claim 6, the modified Huebner’s bone plate discloses further comprising a proximal hole (268, Figure 6 of Huebner) proximal the central opening.
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Regarding claim 7, the modified Huebner’s bone plate discloses wherein the template defines a longitudinal axis, further comprising: radiopaque indicia (252, 254, [paragraph 0076] of Huebner) on opposing sides of an edge of the main body (figure 7 of Huebner); and an alignment hole (see the diagram below of Huebner) through the main body, wherein the radiopaque indicia and a center of the alignment hole lie along an axis transverse to the longitudinal axis.
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Regarding claim 8, the modified Huebner’s bone plate discloses wherein the template includes an alignment feature (292, Figure 10 of Huebner) extending from the main body into the central opening.
Claims 9 and 14-18 are rejected under 35 U.S.C. 103 as being unpatentable over US Huebner et al. (US Publication 2014/0163621), hereinafter Huebner in view Whitaker et al. (US Publication 2018/0177510), hereinafter “Whitaker”.
Regarding claim 9, Huebner discloses an orthopedic repair system, comprising: a bone plate (52, Figure 6); and an alignment template (250, Figure 7) including a bone-facing lower surface (274, Figure 7), an upper surface (272, Figure 6) opposite the lower surface, and a cavity (270, Figure 7) extending inwardly from the lower surface towards the upper surface.
Huebner fails to disclose wherein the cavity is capable of receiving a portion of the bone plate and the cavity includes a wall corresponding to a side surface of the bone plate such that the wall closely surrounds the bone plate, and the bone plate moves either one of or both longitudinally and laterally with the alignment template when the portion of bone plate is received in the cavity.
Whitaker discloses a screw guide (100, Figure 6) including a guide body (106, Figure 6) having a first guide surface (110, Figure 6) and an opposing second guide surface (112, Figure 7). The second guide surface (112, Figure 7) constitutes a plate-facing lower surface when the guide is coupled to the bone plate. Whitaker discloses first and second leg portions (118a and 118b, Figure 7) extending from the second guide surface (112, Figure 7). The led portions include opposing inner surfaces (128, Figure 7) that face one another and define a plate receiving gap (132, Figure 7). The opposing inner surfaces (128, Figure 7) constitute walls corresponding to the opposing side surfaces (42 and 44 of bone plate 20, Figure 3). Whitaker discloses inwardly extending lateral extensions (140, Figure 7) that cooperate with second guide surface (112, Figure 7) and inner surfaces (128, Figure 7) to receive and retain the bone plate within the guide. The inner surfaces may be parallel or tapered to conform to and engage the bone plate.
Therefore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the lower plate engaging portion of Huebner’s guide block, with the plate receiving attachment arrangement of Whitaker to provide secure and properly aligned coupling between the guide and bone plate while allowing the guide and plate to be positioned together.
Regarding claim 14, Huebner’s bone plate discloses wherein the bone plate includes a central window (128,Figure 4] of Huebner) defined in part by a partial hole, and wherein the alignment template includes a guide hole (263, Figure 7 of Huebner) capable of aligning with the partial hole of the central window when the bone plate is received in the cavity of the alignment template [paragraph 79 of Huebner].
Regarding claim 15, Huebner’s bone plate discloses wherein the partial hole includes threading [314, Figure 11 of Huebner] capable of having a threaded connection with a fixation screw having a shank and a threaded head extending from the shank.
Regarding claim 16, Huebner’s bone plate discloses the alignment template including a guide hole, further comprising a drill guide (302, Figure 11 of Huebner) including a shaft (309, Figure 11 of Huebner) and a flange (312, Figure 1 of Huebner) extending around the shaft, wherein the drill guide is capable of being simultaneously received through the guide hole of the alignment template and attached to the bone plate such that the alignment template is held between the flange of the drill guide and the bone plate [paragraph 81 of Huebner].
Regarding claim 17, Huebner’s bone plate discloses wherein the guide hole of the alignment template includes a step (310, Figure 11 of Huebner), and wherein the step lies between the flange and the bone plate when the drill guide is received through the guide hole and attached to the bone plate (see Figure 11 of Huebner).
Regarding claim 18, Huebner’s bone plate discloses wherein the flange extends from a location along the shaft of the drill guide such that the flange is spaced from the step when the drill guide is received through the guide hole and attached to the bone plate (see Figure 11 of Huebner).
Allowable Subject Matter
Claims 10-13 and 19-20 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.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DIANA S JONES whose telephone number is (571)270-5963. The examiner can normally be reached Monday to Friday (8am to 4pm EST).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kevin Truong can be reached at 571-272-4705. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Diana Jones/Examiner, Art Unit 3775
/KEVIN T TRUONG/Supervisory Patent Examiner, Art Unit 3775
