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 .
Priority
The claims have support going back to US Provisional 63/321,404 filed March 18, 2022 and as such have an effective filing date of March 18, 2022.
Election/Restrictions
Applicant’s election without traverse of Group 1 (claims 1-4) in the reply filed on 12/16/2025 is acknowledged.
Claims 5-8 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 12/16/2025.
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 “one or more longitudinal ribs” in claim 2 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 Objections
Claim 3 objected to because of the following informalities:
Claim 3 should recite “[[the]] a midpoint of a [[the]] PIP joint”. Appropriate correction is required.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claim 3 is rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101). Claim 3 recites “a circumferential rib disposed on the outer surface of the cylindrical body at a location approximating the mid-point of the PIP (proximal interphalangeal) joint" and as such positively recites part of the human body. It is suggested to recite “at a location for approximating the mid-point of the PIP joint”.
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.
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.
Claim 1, 3 are rejected under 35 U.S.C. 103 as being unpatentable over Chawla GB 2421187 in view of Palmer US 2015/0073413.
Regarding Claim 1, Chawla discloses an apparatus (Fig 8) comprising a cylindrical body (#10, see also Fig 2-3 where it is cylindrical) having a lumen (#26, see Fig below) disposed therein, the body having a proximal end and a distal end (see Fig below),
the body having at least two apertures (#12) near the distal end (see Fig below), the apertures connecting the lumen to the external surface of the body (see Fig below), and
slidably disposed within the lumen extending into each aperture, a tine (#30, see Fig below, page 8 lines 5-10) having a bone engagement end (tip of the tine #30) and a force receiving end (opposite the bone engaging end, see Fig below), and
a displacement element slidably disposed in the lumen adjacent the force receiving end of the tines (see Fig below, page 8 lines 5-10), the displacement element having a tether (see Fig below, page 7 lines 20-30 where the displacement element is in the form of a tether) adapted to transmit tension force applied thereto to the displacement element, and thence to the tines, causing the tines to extend through the apertures and beyond the external surface of the body, to engage bone (page 8 lines 5-10 where the tension force is applied to cause the tines to extend through the apertures and engage bone).
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Chawla discloses the claimed invention as discussed above where the apparatus is used within the intramedullary canal of bone (see title, abstract) and there can be more than one displacement element (see also Fig 7 and page 7 lines 20-30) but does not disclose the apparatus is for surgical correction of an abnormal flexion of a joint but does not disclose the body has at least two apertures near the proximal end, a tine (for the apertures near the proximal end) having a bone engagement end and a force receiving end, and a displacement element (for the tines near the proximal end) slidably disposed in the lumen adjacent the force receiving end of the tines, the displacement element having a tether adapted to transmit tension force applied thereto to the displacement element, and thence to the tines, causing the tines to extend through the apertures of the proximal end and beyond the external surface of the body, to engage bone.
Palmer discloses an apparatus (Fig 20) is used in the intramedullary canal (paragraph 12) and for surgical correction of an abnormal flexion of a joint of the foot (paragraph 7) comprising a cylindrical body (see Fig below) having a lumen (see Fig below, Fig 21) disposed therein, the body having a proximal end and a distal end (see Fig below), the body having at least two apertures near each of the proximal and distal ends (see Fig below, Fig 21 where each end has at least two aperture through which tines #125 extend out from), the apertures connecting the lumen to the external surface of the body (see Fig below, Fig 21), a tine (#125) having a bone engagement end (tip of the tine, see Fig below), the tines to extend through the apertures and beyond the external surface of the body, to engage and secure onto bone (see Fig below, paragraph 77).
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It would have been obvious to one having ordinary skill in the art at a time before the effective filing date of the claimed invention to modify the apparatus of Chawla to be sized to fit in the intramedullary canal of an interphalangeal joint such that it can be used for correction of an abnormal flexion of a joint and to include apertures for tines at the proximal end in view of Palmer because this provides a known alternate placement and use for an intramedullary device, where the apertures at the proximal end allow for tines at the proximal end the body to secure onto bone, such that both the proximal and distal ends of the body can be secured to bone. As such, it would have also been obvious to one having ordinary skill in the art at a time before the effective filing date of the claimed invention to modify the Chawla as modified by Palmer to include another displacement element having a tether with another set of tines with a bone engaging end and force receiving end (similar to that shown in Fig 8) in order to engage the apertures near the proximal end. It is noted that with the modification, the other displacement element would be similar to that shown in Fig 8 in Chawla but with tines located proximally for the apertures near the proximal end (as discussed above, see also Fig 7 and page 7 lines 20-30 in Chawla where there can be multiple displacement elements or a single displacement element for the tines).
Regarding Claim 3, Chawla as modified by Palmer discloses the claimed invention as discussed above where the apparatus can be used on a PIP joint (paragraph 7 in Palmer) but does not disclose a circumferential rib disposed on the outer surface of the cylindrical body at a location approximating the mid-point of the PIP joint.
Palmer discloses another embodiment with a cylindrical body (#20, Fig 15a) with a circumferential rib (#83, Fig 15a) disposed on the outer surface of the cylindrical body at a location approximating the mid-point of the PIP joint (Fig 15a, paragraph 70, see also Fig 12-13 where the rib would be placed at a mid point of a PIP joint) to limit how far the apparatus can be pushed into either side of the intramedullary canal during implantation in the PIP joint (paragraph 70, Fig 12-13).
It would have also been obvious to one having ordinary skill in the art at a time before the effective filing date of the claimed invention to modify the body of Chawla as modified to include a circumferential rib in view of another embodiment of Palmer above because it limits how far the apparatus can be pushed into either side of the intramedullary canal during implantation in the PIP joint
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Chawla GB 2421187 and Palmer US 2015/0073413, as applied to claim 1 above, and in further view of Elleby US 2016/0015437.
Chawla as modified discloses the claimed invention as discussed above but does not disclose one or more longitudinal ribs disposed on the outer surface of the cylindrical body.
Elleby discloses an apparatus (Fig 1) with a cylindrical body (#12) having one or more longitudinal ribs (#40, paragraph 26, Fig 1, 4) disposed on the outer surface of the cylindrical body (Fig 1, 4) to help prevent rotation of the body (paragraph 26).
It would have been obvious to one having ordinary skill in the art at a time before the effective filing date of the claimed invention to modify Chawla as modified to include on or more longitudinal ribs in view of Elleby above because the ribs prevent rotation of the body.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Chawla GB 2421187 and Palmer US 2015/0073413, as applied to claim 1 above, and in further view of Elleby US 2016/0015437.
Chawla as modified discloses the claimed invention as discussed above where the cylindrical body is comprised of a proximal segment (segment adjacent to and including the proximal end, see annotated Fig 8 of Chawla above in claim 1) and a distal segment (segment adjacent to and including the distal end, see annotated Fig 8 of Chawla above in claim 1), where Palmer also discloses the body can be curved to adapt to the curvature of the bone of the feet (Fig 97 and paragraph 92 in Palmer) but does not disclose wherein the axis of the distal segment is displaced about ten degrees downward from the axis of the proximal segment when implanted.
Palmer discloses an apparatus with a cylindrical body (#12, Fig 1) with a proximal and distal segment, wherein the axis of the distal segment is displaced about ten degrees (angle θ in Fig 1, see below) downward from the axis of the proximal segment when implanted to closely duplicate the natural bend of toes of feet (paragraph 24-25).
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It would have been obvious to one having ordinary skill in the art at a time before the effective filing date of the claimed invention to modify Chawla as modified to have the axis of the distal segment is displaced about ten degrees downward from the axis of the proximal segment when implanted in view of Elleby above because this angle closely duplicates the natural bend of toes of the feet.
Conclusion
See PTO-892 for art of cited interest, in particular other intramedullary devices that use barbs/tines.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAN CHRISTOPHER L MERENE whose telephone number is (571)270-5032. The examiner can normally be reached Mon-Fri 8:30 am - 6pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Eduardo Robert can be reached at 571-272-4719. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JAN CHRISTOPHER L MERENE/Primary Examiner, Art Unit 3773