DETAILED ACTION
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 June 23, 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 features of claims 23 and 31, “insertion of the fixation screw through the first metatarsal and into the medial cuneiform” 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.
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.
Claims 23 and 25-33 are rejected under 35 U.S.C. 112(a), 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.
In claim 23, the recitation “the fixation screw is configured to be inserted through the first metatarsal and into the medial cuneiform across the tarsal-metatarsal joint” seeks to introduce new matter. Applicant’s disclosure describes using a separate bone fixation means independent of the bone plate but does not describe inserting the fixation means through the first metatarsal and into the medial cuneiform across the tarsal-metatarsal joint for additional fixation after placement of the bone plate.
In claim 25, the recitation “inserting two screws having a second length greater than the first length through the bone plate” seeks to introduce new matter. Applicant’s disclosure describes “second length greater than the first length” only in the context of external fasteners 150 used for additional fixation of bone, “may be sized different than the bone plate fasteners 60 included in the container 20, such that, for example, the external fasteners 150 have a diameter different (e.g., greater) than a diameter of the bone plate fasteners 60 and/or a length different (e.g., greater) than a length of the bone plate fasteners. The at least one and no more than two external fasteners 150 can be used, with or without washers 200, as a separate bone fixation means independent of the bone plates 40. For example, the external fastener 150 can have an end (e.g., an end of the external fastener 150 opposite an end near which the washer 200 is disposed) inserted into a bone such to provide additional fixation of that bone.”
Applicant’s disclosure does not describe the criticality of providing screws inserted through the bone plate having a second length greater than the first length. Applicant’s disclosure provides support for different length fasteners wherein the lengths could be same, greater or lesser with no description of why the particular claimed combination is necessary. It is suggested that Applicant use alternate language, for e.g. a second length different from the first length.
In claim 31, the recitation “..comprises inserting the fixation screw through the first metatarsal and into the medial cuneiform across the tarsal-metatarsal joint” seeks to introduce new matter. Applicant’s disclosure describes applying a bone fixation pin prior to placement of the bone plate. In claim 25, the insertion of the fixation screw appears to be after placement of the bone plate.
Appropriate correction is required.
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 19 and 28 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.
In claims 19 and 28, the recitation “…two fixation holes positioned in a same plane” is incomplete. It is unclear what the “same plane” is and what its orientation is with respect to the plate body, for e.g. with respect to the longitudinal axis of the plate.
Appropriate correction is required.
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) 18-24 are rejected under 35 U.S.C. 103 as being unpatentable over Blitz et al. (US 8828063) in view of Schelling (US 8162996) and Lewis et al. (US 9060822).
Regarding claim 18, Blitz et al. disclose a system for a tarsal-metatarsal fusion procedure, the system including: a bone plate 20 having a distal region 22 configured to be positioned on a first metatarsal, a proximal region 24 configured to be positioned on a medial cuneiform (Fig. 5A), and an intermediate region extending from the distal region to the proximal region, the intermediate region being configured to be positioned across a tarsal-metatarsal joint separating the first metatarsal from the medial cuneiform, wherein the distal region has four fixation holes, the proximal region has three fixation holes, and the intermediate region is devoid of fixation holes (see marked up Fig. 2 on the following page); and at least seven screws corresponding to the number of holes shown in the embodiment of Fig. 2 (col. 4, lines 37-67, cols. 5-6 and col. 7, lines 1-54).
Blitz et al. disclose the proximal and distal region to have a plurality of holes (two or more) and disclose an embodiment wherein the proximal region has two holes or three holes and the distal region has two holes or four holes (col. 5, lines 13-49).
Regarding claim 19, distal region 22 includes two fixation holes (44, 46) or (42, 46) positioned in a same plane (interpreted to be a plane that contains an axis through the respective centers of the holes).
Regarding claim 20, Blitz et al. disclose bone plate 20 to have a twist or bend around a longitudinal axis of the body.
Regarding the recitation, “wherein the distal region has four fixation holes and the proximal region has two fixation holes,” it would have been obvious to one of ordinary skill in the art to have provided four holes in the distal region and two holes in the proximal region, as suggested by Blitz et al. amounting to choosing from a finite number of fixation holes (any number equal or greater than two) for the predictable result of fixation of the plate to underlying bone.
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Blitz et al. disclose all elements of the claimed invention except for: (1) a fixation screw configured to be inserted into the first metatarsal; and (2) at least two screws having a second length greater than the first length and configured for use with the bone plate.
Regarding claims 18 and 23, it is well known to provide one or more additional fasteners for providing additional compression of a bone discontinuity separately from a bone plate, as evidenced by Schelling in a kit configuration (Figs. 7 and 10F, col. 5, lines 4-34, col. 11, lines 33-67 and col. 12, lines 1-10).
It would have been obvious to one of ordinary skill in the art to have provided the Blitz et al. system along with additional fasteners or fixation screws, as taught by Schelling in a kit configuration to provide for additional compression of a bone discontinuity.
The combination of Blitz et al. and Schelling discloses all elements of the claimed invention except for at least two screws having a second length greater than the first length and configured for use with the bone plate.
Lewis et al. disclose differing lengths of screws for fixing a plate to bone wherein a shorter screw may be required for compression generation. Lewis et al. also disclose the screws to be unicortical screws because they pass through one cortical surface of the bone (Figs. 1 and 4, col. 7, lines 43-67, cols. 8-12 and col. 13, lines 1-35).
It would have been obvious to one of ordinary skill in the art to have provided screws of varying lengths some shorter and some longer, as taught by Lewis et al., in the system or kit of the combination of Blitz et al. and Schelling for compression generation.
Claim(s) 25-33 are rejected under 35 U.S.C. 103 as being unpatentable over Fallin et al. (US 20160199076 A1) in view of Blitz et al. (US 8828063), Schelling (US 8162996) and Lewis et al. (US 9060822).
Fallin et al. disclose cutting the first metatarsal and the medial cuneiform utilizing a guide and a saw blade; rotating the bones to close the gap and securing the bone in the aligned position utilizing a plate (para [0050]-[0057]).
Fallin et al. disclose all the elements of the claimed invention except for: (1) the features of the claimed plate and screws; and (2) a fixation screw inserted through the first metatarsal at a location spaced from the bone plate to separately fixate the first metatarsal.
The combination of Blitz et al., Schelling and Lewis et al. disclose all elements of the plate, screws and fixation screw, as discussed for claims 18-24.
It would have been obvious to one of ordinary skill in the art to have substituted the bone plate in the method of Fallin et al. with the bone plate, screws and fixation screw kit of the combination of Blitz et al., Schelling and Lewis et al., to better secure the metatarsal and the medial cuneiform in a desired orientation for fusion.
The claimed method steps are performed when the plate, fasteners and fixation screw of the combination Blitz et al., Schelling and Lewis et al., is utilized for correcting a foot deformity according to the method of Fallin et al.
Response to Arguments
Applicant’s arguments have been considered by the Examiner.
The Examiner agrees that drawings do not need to separately depict every aspect of Applicant’s invention. However, Applicant’s disclosure does not describe permanent fixation of the first metatarsal and the medial cuneiform with a screw that crosses joint space.
Applicant’s arguments with respect to rejections of claims 23 and 31 under 35 USC 112(a) are not persuasive. Applicant’s disclosure describes insertion of a bone fixation pin crossing the joint space between bones to compress the bones together prior to installation of a bone plate, for greater accuracy during a surgical procedure, interpreted to mean temporary fixation. Applicant’s disclosure does not describe the additional fixation of bone with external fasteners to be placement of a fixation screw through the first metatarsal and into the medial cuneiform across the tarsal-metatarsal joint.
Applicant’s arguments with respect to the rejection of claims 19 and 28 under 35 U.S.C. 112(b) are not persuasive because “same plane” is not tied to an axis, for e.g. longitudinal axis of the plate.
Applicant’s arguments with respect to the rejections under 35 USC 103(a) over Blitz et al. (US 8828063) in view of Schelling (US 8162996) and Lewis et al. (US 9060822) are not persuasive because both Blitz et al. and Schelling describe plates used for compression of metatarsals for fracture repair and fusions. Contrary to Applicant’s arguments, Blitz et al. does not preclude any screws from passing through the fusion site (col. 7, lines 25-42).
New grounds of rejection have been made in this office action.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Anu Ramana whose telephone number is (571)272-4718. The examiner can normally be reached 8:00 am-5:00 pm.
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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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October 9, 2026
/Anu Ramana/Primary Examiner, Art Unit 3775
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