DETAILED ACTION
Specification
The disclosure is objected to because of the following informalities. On page 1, para [0001], the status of copending applications, which have since matured as patents, must be updated.
Appropriate correction is required.
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. 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.
Claims 18-33 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 claims 18 and 33, the recitation “at least four screws having a first length and configured for use with the bone plate” seeks to introduce new matter because the recitation “at least” is a range of the number of screws without an upper limit. Applicant’s disclosure states “Including one, two, three, or four bone plate fasteners 60 more than the number of fixation holes of the bone plates 40 included in the container 20 can be beneficial in instances where bone plate fasteners 60 may be dropped or lost during a surgical procedure.”
In claims 18 and 33, the recitation “at least two screws having a second length greater than the first length and configured for use with the bone plate” seeks to introduce new matter. Applicant’s disclosure states “Additionally, the at least one and no more than two external fasteners 150 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.” The two screws having a second length greater than the first length are used as a separate fixation means independent of the bone plate.
In claims 18 and 33, the recitation of “a fixation screw” in addition to the four screws and the two screws seeks to introduce new matter because Applicant’s disclosure states the two screws are configured to provide separate fixation from the bone plate.
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 as previously discussed but does not describe inserting the fixation means through the first metatarsal and into the medial cuneiform across the tarsal-metatarsal joint.
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 using a separate bone fixation means independent of the bone plate as previously discussed but does not describe inserting the fixation means through the first metatarsal and into the medial cuneiform across the tarsal-metatarsal joint.
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 18-33 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 18 and 33, the recitation of “a fixation screw configured to be inserted….from the bone plate” in addition to the recitation “at least two screws having a second length greater than the first length and configured for use with the bone plate” renders the claims vague and indefinite because it amounts to double recitation of elements (see rejection under 35 USC 112 (a)).
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).
PNG
media_image1.png
387
436
media_image1.png
Greyscale
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.
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) 26-33 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 carefully considered by the Examiner. New grounds of rejection have been made in this office action.
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.
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kevin Truong can be reached on (571)272-4705. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
December 19, 2025
/Anu Ramana/Primary Examiner, Art Unit 3775
Prosecution Insights