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 office action is in response to the Request for Continued Examination (RCE) received on September 15, 2026. Claims 1-27 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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 15, 2026 has been entered.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the threaded head portion (as to claim 23); second and third receiving structures having threads that engage the threaded head portion (as to claim 24); the head portion of the second and third screw being flush with the second surface (as to claim 25); a first receiving structure that is unthreaded (as to claim 26); a planar bone plate (as to claim 27) must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 23-27 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
With respect to claim 23, the originally filed disclosure does not provide support for one or more of the second and third screws having a threaded head portion. The description specifically identifies head 20 of screw 6 as smooth and without threading (see Figures 2 and 3).
With respect to claim 24, the originally filed disclosure does not provide support for one or more of the second and third receiving structures having threads that engage the threaded head portion of the second or third screws. The disclosure states one that a bone plate can include one or more receiving structures defining holes sized to receive screws; it does not disclose threaded plate holes engaging threaded screw heads.
With respect to claim 25, the originally filed disclosure does not provide support for the claimed first and second opposed plate surfaces in combination with the first surface contacting the fibula and the head portion of the second and third screw being flush with the second surface.
With respect to claim 26, the originally filed disclosure does not reasonably convey possession of a first receiving structure that is unthreaded. Merely disclosing a receiving structure defining a hole sized to receive a screw does not expressly or inherently establish whether the receiving structure is threaded or unthreaded.
With respect to claim 27, the originally filed disclosure does not provide support for a planar bone plate having first, second, and third receiving structures whose screw receiving axes are substantially parallel to one another. Neither “planar” nor the claimed parallel axis relationship is disclosed in the originally filed specification.
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 1-4, 12, and 14-15 are rejected under 35 U.S.C. 103 as being unpatentable over Dacosta et al. (US Publication 2019/0015140), hereinafter “Dacosta”; in view of Chiu et al (EP 2,085,039 A1), hereafter “Chiu”; and further in view of Terrill et al. (US Publication 2015/0250515), hereafter “Terrill”.
Regarding claim 1, Dacosta discloses second and third screws (bone screw fasteners 350, 360, 370, 380; Figures 33-38) and a bone plate (i.e., plate 300; Figures 19-26, 33-38) including at least first, second, and third receiving structures (i.e., openings 322, 324, 326, 328, Figures 19-20) respectively sized to receive the first, second, and third screws. Dacosta expressly teaches screws 350, 360, 370,and 380 inserted through respective openings 326,328,322,and 324 of plate 300.
Dacosta fails to disclose a syndesmotic fixation system comprising at least a first screw comprising a superelastic material, the first screw having a length configured to span a tibia and a fibula at a syndesmosis joint. Dacosta also fails to disclose the first screw including a fully threaded shaft.
However, Chiu discloses a syndesmotic fixation system [paragraph 0037] comprising: at least a first screw (connector 10 having body 11; Figures 2-5) comprising a superelastic material (i.e., body 11 comprising nitinol), the first screw having a length configured to span a tibia (T) and a fibula (F) at a syndesmosis joint (S). Chiu teaches that at least central portion 14, and preferably all of body 11 of bone fixation device 10 is fabricated from superelastic and shape memory material such as nitinol, and that connector 10 connects the tibia and fibula to repair the ankle syndesmosis [paragraph 0051].
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the plate and screw fixation system of Dacosta with a superelastic syndesmotic fixation screw that spans a syndesmosis joint as taught by Chiu in to provide a known fixation member having flexibility and fatigue resistance suitable for syndesmotic fixation.
However, Terrill teaches a syndesmosis bone screw (100; Figures 1A-1D, 10) having a second screw element (104, Figure 1A) including a shaft (108, Figure 1A), wherein the shaft (108, Figure 1A) may be fully threaded, the shaft including threaded portion (110, Figure 1A) having external thread (112, Figure 1B) [paragraph 0036]. Terrill further teaches the same bone screw (100) positioned across syndesmosis joint (1002) between tibia (1004) and fibula (1006) (Figure 10, [paragraph 0051]).
Therefore, it would have been obvious to one of ordinary skill in the art to provide the modified Dacosta’s system with the fully threaded shaft configuration taught by Terrill to provide a threaded bone engagement along the shaft while retaining known superelastic properties of the fixation member.
Regarding claim 2, the modified Dacosta’s system discloses further comprising a cannulated drill bit (i.e. described in [paragraph 0079] but not shown) and a guide wire (150, Figure 2 of Dacosta).
Regarding claim 3, the modified Dacosta’s system discloses further comprising a drill bit (270, Figure 2 of Dacosta).
Regarding claim 4, the modified Dacosta’s system discloses wherein the first screw comprises nitinol [paragraph 0051 of Chiu].
Regarding claim 12, Dacosta discloses a Lisfranc fixation system comprising an alignment guide (200, Figure 1), a cannulated drill bit (i.e. described in [paragraph 0079] but not shown), and a guide wire (k-wire 150, i.e. the k-wire is inserted through tissue protector 240 and a cannulated drill is subsequently advanced over k-wire (150) [paragraph 0079]), and at least one screw (360) having a length configured to span at least two bones in a Lisfranc joint complex (i.e., fastener 360 extends through navicular bone 402 and into intermediate cuneiform 406 [paragraph 0080]). Dacosta also teaches a fully threaded cross screw (fastener 250) extending through medial cuneiform 404 and into navicular bone 402 [paragraph 0082]).
Dacosta fails to disclose that the claimed screw comprises a superelastic material and a fully threaded shaft.
Chiu, however, teaches an orthopedic fixation fabricated from superelastic nitinol (connector 10 having body 11; Figures 2-5) comprising a superelastic material (i.e., body 11 comprising nitinol).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the plate and screw fixation system of Dacosta to include the superelastic syndesmotic fixation of Chiu because Chiu expressly teaches a superelastic nitinol screw for fixation of the same tibia and fibula syndesmotic joint and such substitution would have predictably provided a known fixation member having flexibility and fatigue resistance suitable for syndesmotic fixation.
Terrill teaches a syndesmosis bone screw (100; Figures 1A-1d, 10) having a second screw element (104) including a shaft (108), wherein the shaft (108) may be fully threaded, the shaft including threaded portion (110) having external thread (112) [paragraph 0036]. Terrill further teaches the same bone screw (100) positioned across syndesmosis joint (1002) between tibia (1004) and fibula (1006) (Figure 10, [paragraph 0051]).
Therefore, it would have been obvious to one of ordinary skill in the art to provide the modified Dacosta’s system with the fully threaded shaft configuration taught by Terrill to provide a threaded bone engagement along the shaft while retaining known superelastic properties of the fixation member.
Regarding claim 14, the modified Dacosta’s system further comprising a drill bit (270, Figure 2 of Dacosta).
Regarding claim 15, the modified Dacosta’s system wherein the at least one screw comprises nitinol (Chiu discloses a connector 10 having body 11; Figures 2-5) comprising a superelastic material (i.e., body 11 comprising nitinol)).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable Dacosta et al. (US Publication 2019/0015140), hereinafter “Dacosta”; in view of Chiu et al (EP 2,085,039 A1), hereafter “Chiu”; Terrill et al. (US Publication 2015/0250515), hereafter “Terrill”; and further in view of Peterson et al. (US Publication 2018/0092677), “Peterson”.
Regarding claim 5, the modified Dacosta’s system fails to disclose wherein the first screw is solid.
Peterson, however, teaches orthopedic fixation screws that may be non-cannulated or solid, and expressly teaches that the disclosed screw embodiments may be solid screws or cannulated screws [paragraphs 0010, 0014, and 262].
Therefore, it would have been obvious to one of ordinary skill in the art to provide the nitinol first screw of the modified Dacosta’s system wherein the first screw is solid as taught by Peterson, because solid orthopedic screws are known to result in decrease stress shielding, which is advantageous for improved bone healing and fusion.
Claims 23-25 are rejected under 35 U.S.C. 103 as being unpatentable over Dacosta et al. (US Publication 2019/0015140), hereinafter “Dacosta”; in view of Chiu et al (EP 2,085,039 A1), hereafter “Chiu”; Terrill et al. (US Publication 2015/0250515), hereafter “Terrill”; and further in view of Anapliotis et al. (US Publication 2009/0306723), hereinafter “Anapliotis”.
Regarding claim 23, the modified Dacosta’s system fails to disclose wherein one or more of the second and third screws have a threaded head portion.
However, Anapliotis teaches a bone screw (6) having a screw head (7) provided with an external thread (9), wherein thread (9) is configured to engage an internally threaded opening in bone plate (1) (Figure 3).
Therefore, it would have been obvious to one of ordinary skill in the art to provide one or more of the second and third plate screws of the modified Dacosta’s system with threaded head portion taught by Anapliotis, because threaded screw heads engaging threaded plate openings were a known mechanism for angularly stable screw to plate fixation.
Regarding claim 24, the modified Dacosta’s system wherein one or more of the second and third receiving structures have threads which engage the threaded head portion of one or more of the second and third screws (i.e., one or more receiving structures having threads which engage the threaded head portion of a screw, threaded bore (5e) engages internal thread (5d) of plate (1) engaging external thread (9) of screw head (7) (see Figure 3) of Anapliotis).
Regarding claim 25, the modified Dacosta’s system wherein the bone plate (300 having a first bone facing surface see interior surface of 312 of Dacosta) has a first surface (interior surface 312 of Dacosta) and a second surface (exterior surface 310 of Dacosta), the first surface disposed opposite the second surface, wherein the first surface contacts the fibula and the head portion of the one or more second and third screws is flush with the second surface (i.e., Anapliotis teaches bone screw (6) having head (7) positioned such that head (7) terminates flush with the surface of plate (1) and does not project above the plate, and further teaches screws 6, 16, 26, and 36 positioned through plate (1) (see Figures 3-4).
Claims 26 is rejected under 35 U.S.C. 103 as being unpatentable over Chiu et al (EP 2,085,039 A1) “Chiu” in view of Dacosta et al. (US Publication 2019/0015140), hereinafter “Dacosta”; Terrill (US Publication 2015/0250515); and further in view of Strnad et al. (US Publication 2008/0021477).
Regarding claim 26, the modified Dacosta’s system fails to disclose wherein the first receiving structure is unthreaded.
Strnad, however, teaches an orthopedic bone plate having both threaded holes for locking fixation members and non-threaded holes for alternative fixation mechanisms, thereby expressly establishing non-threaded plate receiving structures as a known plate hole configuration [paragraph 0044].
Therefore, it would have been obvious to one of ordinary skill in the art to provide the receiving structure for the first syndesmotic screw as an unthreaded opening, because threaded and non-threaded bone and plate openings were known alternatives selected according to whether locking engagement between the screw head and plate was desired.
Claims 27 is rejected under 35 U.S.C. 103 as being unpatentable over Chiu et al (EP 2,085,039 A1) , hereinafter “Chiu” in view of Dacosta et al. (US Publication 2019/0015140), hereinafter “Dacosta”; and further in view of Frigg et al. (US Publication 2002/0058940).
Regarding claim 27, Chiu discloses a syndesmotic fixation system comprising: at least a first screw comprising a superelastic material (bone fixation device 10 and body comprises nitinol), the first screw having a length configured to span a tibia (T) and a fibula (F) at a syndesmosis joint (S).
Chiu fails to disclose second and third screws, and a planar bone plate including at least first, second, and third receiving structures respectively sized to receive the first, second, and third screws, the first, second, and third receiving structures having screw receiving axes that are substantially parallel to one another.
Dacosta teaches second and third screws (350, 360, 370, 380) and a bone plate (300) including at least first, second, and third receiving structures (openings 322, 324, 326, 328, 328) respectively sized to receive first, second, and third screws [paragraphs 0072-0080].
Therefore, it would have been obvious to a person of ordinary skill in the art at the time the invention was made to modify the system of Chiu with the bone plate (300) and second and third bone screws (350, 360, 370, 380) as taught by Dacosta in order to provide additional points of fixation and stabilization of the bone plate while permitting the first syndesmotic screw to extend through the plate and across the tibia and fibula to provide supplemental plate fixation and stabilization.
Frigg, however, teaches a bone plate (1) having an upper surface (2), bone-contacting surface (3) and a plurality of screw receiving holes (5), wherein the screw- hole axes are substantially perpendicular to the plate surfaces and may be parallel to one another. Frigg further teaches a generally thin bone plate having multiple screw receiving openings for fixation screws (Figure 1).
Therefore, it would have been obvious to a person of ordinary skill in the art at the time the invention was made to modify the modified Chiu’s system with the planar plate having first, second, and third screw receiving structures whose screw receiving axes are parallel to one another as taught by Frigg in order to provide predetermined and parallel trajectories for the respective fixation screws using a known plate and bone configuration.
Conclusion
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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/Diana Jones/Examiner, Art Unit 3775
/KEVIN T TRUONG/Supervisory Patent Examiner, Art Unit 3775
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