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 .
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 feature “..the second row includes only two second bone fixation holes, such that no bone fixation holes of the bone plate are aligned with the two second bone fixation holes along the longitudinal direction (claim 3)” 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.
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.
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.
Claim 3 is 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.
In claim 3, the recitation “..wherein the second row includes only two second bone fixation holes, such that no bone fixation holes of the bone plate are aligned with the two second bone fixation holes along the longitudinal direction” seeks to introduce new matter. Applicant’s disclosure, as originally filed, does not describe this feature (see objection to the Drawings).
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 1-11 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 claim 1, the recitation “…wherein no bone fixation holes of the bone plate are aligned with the two third bone fixation holes along the longitudinal direction” renders the claim vague and indefinite. The previous recitation “..a third row of two and only two third bone holes arranged such that a third straight line oriented along the longitudinal direction passes through each of the third bone fixation holes” implies that there are only two holes in the third row. Therefore, the recitation “…wherein no bone fixation holes of the bone plate are aligned with the two third bone fixation holes along the longitudinal direction” is redundant. It is suggested that this recitation be deleted for clarity.
In claim 1, the recitation “…immediately adjacent ones of the third fixation holes are spaced from each other a third distance along the second straight line,..” renders the claim vague and indefinite because the third distance is measured along the third straight line. Further, since the third row has only two bone fixation holes, the recitation “immediately adjacent ones of the third bone fixation holes” renders the claim vague and indefinite because it implies there are more than two bone fixation holes in the third row.
In claims 2, and 13-15, the recitation “substantially identically sized and shaped” renders the claims vague and indefinite because Applicant’s disclosure does not describe this feature to understand the scope of Applicant’s invention. For e.g. size ranges or types of shapes.
Appropriate correction is required.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 15 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of claim 14 upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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) 1-19 are rejected under 35 U.S.C. 103 as being unpatentable over Rise et al. (US 20140316472 A1).
Regarding claims 1 and 12, Rise et al. disclose a bone plate (100, 200) (Figs. 1-3 and 4A-4C) including: a plate body having a plurality of bone fixation holes; wherein the bone fixation holes are arranged in a first row of a first bone fixation holes arranged such that a first straight line oriented along a longitudinal direction passes through each of the first bone fixation holes; a second row of second bone fixation holes arranged such that a second straight line oriented along the longitudinal direction passes through each of the second bone fixation holes; a third row of third bone fixation holes arranged such that a third straight line oriented along the longitudinal direction passes through each of the third bone fixation holes; a first leg or flexible arm that extends between a first one of the second bone fixation holes and a first one of the third bone fixation holes, wherein the first flexible arm is positionally adjustable so as to adjust an orientation of the first one of the third bone fixation holes relative to the first one of the second bone fixation holes; and a second leg or flexible arm that extends between a second one of the second bone fixation holes and a second one of the third bone fixation holes, wherein the second flexible arm is positionally adjustable (by means of crimped or non-linear leg 118 or 226) so as to adjust an orientation of the second one of the third bone fixation holes relative to the second one of the second bone fixation holes, wherein immediately adjacent ones of the first bone fixation holes are spaced from each other a first distance along the first straight line, immediately adjacent ones of the second bone fixation holes are spaced from each other a second distance along the second straight line and immediately adjacent ones of the third bone fixation holes are spaced from each other a third distance along the third straight line and wherein each of the bone fixation holes is configured to receive a screw (Figs. 1-3 and 4A-4C, paras [0020], [0022], [0027]-[0029], [0036]-[0037], [0043]-[0044], [0048] and [0049]).
Regarding claims 2 and 13-15, the bone fixation holes in the first row, second row and third row are substantially identically sized and shaped (Figs. 1-3).
Regarding claim 3, Rise et al. disclose that screw holes need to be used at all points of intersection (para [0035]). Thus, the third row can have only two holes when screw holes are provided at only two points of intersection.
Regarding claim 4, Rise et al. disclose the bone fixation holes of the first row are equidistantly spaced from each other (Figs. 1-3).
Regarding claim 5, Rise et al. disclose the bone fixation holes of the third row extend through eyelets of the bone plate (Figs. 1-3).
Regarding claim 6, Rise et al disclose the plate can be contoured to match the anatomical structure of the bones to be repaired (para [0044]). Thus, the height to the first and second arms can be different (for e.g. less than) the respective heights of the bone fixation holes of the second and third rows depending on the needs of situation in which the plate is used (para [0040]).
Regarding claim 7, Rise et al. disclose one of the first and second flexible arms is oriented along the lateral direction (see marked up Fig. 1 below).
PNG
media_image1.png
519
708
media_image1.png
Greyscale
Regarding claim 8, marked up Fig. 1 on the previous page shows the first distance between the first and second line in a lateral direction to be equal to a second distance between the second and third lines.
Regarding claim 9, Rise et al. disclose providing linear or non-linear legs or arms between the bone fixation holes wherein the non-linear arms may be crimped to adjust the distance between the rows of bone fixation holes in a lateral direction.
Regarding claims 10-11 and 18-19, plate body (100 or 200) defines a bottom or bone facing surface and an outer or top surface opposite the bone facing surface, and the plate body defines an aperture that is disposed between the bone fixation holes of the second row and extends from the bone facing surface to the outer surface wherein the second straight line extends through the aperture (see marked up Fig. 1 above).
Regarding claim 16, in Fig. 1, the first flexible arm 102B is oriented along a lateral direction that is perpendicular to the longitudinal direction (Fig. 2 and para [0029]).
Regarding claim 17, bone plate 100 is devoid of bone fixation holes that are disposed between the second row and the third row in the lateral direction (marked up Fig. 1 above).
Regarding claims 1 and 12, Rise et al. disclose all elements of the claimed invention except for: (1) each of the second and third distances is greater than the first distance (claim 1); and (2) the second distance is greater than each of the first and third distances (claim 12).
Rise et al. disclose providing linear and non-linear segments 226 that flex allowing opposingly located screw holes (for e.g. 110 and 116 (Fig. 2) or 211 and 213 (Figs. 4A-4C) to be retracted towards one another or extended away from one another (paras [0047]-[0049]).
It would have been obvious to one of ordinary skill in the art to have manipulated the Rise et al. mesh design by providing non-linear segments or arms between adjacent bone fixation holes along the first, second and third lines so that the segments can be crimped to retract segments such that: (1) each of the second and third distances is greater than the first distance (claim 1); or (2) the second distance is greater than each of the first and third distances, in order to compress or curve the mesh to complement an anatomical structure.
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.
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 at (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.
February 4, 2026
/Anu Ramana/Primary Examiner, Art Unit 3775