DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Election/Restrictions
Applicants’ election with traverse of group I (claims 1-16) in the reply filed on 7/6/2026 is acknowledged. The traversal is on the ground(s) that the search is not burdensome considering the previous searches in the patent family. This is not found persuasive as the elected and nonelected claims have distinct inventive efforts in the art and each invention within a patent family still requires its own examination process.
The requirement is still deemed proper and is therefore made FINAL.
Claims 17-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 7/6/2026.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) PROV or under 35 U.S.C. 120 CIP, 121 CON/DIV, or 365(c) FOR is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 120 and 121 as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of the first paragraph of 35 U.S.C. 112. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed applications (61/793212, 14/766418, 15/911,680 and 17/456191), fail to provide adequate support or enablement in the manner provided by the first paragraph of 35 U.S.C. 112 for one or more claims of this application.
These applications do not appear to disclose specific features of the cap and an externally threaded fastening end (see figures 60-63 of the invention) as presented in the following limitations:
6. The intramedullary nail of claim 1, wherein the cap comprises: an opening extending into the cap from a first end; and an exterior surface surrounding the opening.
7. The intramedullary nail of claim 6, wherein the opening is threaded.
8. The intramedullary nail of claim 7, wherein the fastening end further comprises: a threaded portion positioned on an exterior surface of the body.
9. The intramedullary nail of claim 8, wherein the threaded portion surrounds the insertion opening.
10. The intramedullary nail of claim 8, wherein the threads of the opening of the cap engage the threaded portion of the fastening end.
11. The intramedullary nail of claim 10, wherein the cap is removably threaded onto the fastening end of the body and covers at least one end of the insertion opening.
12. The intramedullary nail of claim 8, wherein the threaded portion is positioned adjacent the insertion opening and the engagement opening.
13. The intramedullary nail of claim 2, wherein the fastening end further comprises: a threaded portion positioned on an exterior surface of the body, wherein the threaded portion is disposed only on an exterior surface of the first fastening segment.
14. The intramedullary nail of claim 2, wherein the fastening end further comprises: a threaded portion positioned on an exterior surface of the body, wherein the threaded portion is disposed only on an exterior surface of the second fastening segment.
15. The intramedullary nail of claim 2, wherein the fastening end further comprises: a threaded portion positioned on an exterior surface of the body, wherein the threaded portion is disposed on at least a portion of an exterior surface of the first fastening segment and at least a portion of an exterior surface of the second fastening segment.
16. The intramedullary nail of claim 1, wherein the cap has an internal thread.
If Applicant alleges that such support exists, the Examiner requests that Applicant point out where in these documents support lies. The effective filing date for claims 6-16 is 1/18/2025 and the effective filing date for claims 1-5 is 3/15/2013.
EXAMINER’S COMMENT
There does not appear to be any overlapping subject matter requiring a Double Patenting rejection regarding US Patents 12256949, 11179166 or 9907562 currently.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1 and 2 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Czartoski (US 20070123876) in view of Sohngen (US 20020151898).
With respect to claim 1, Czartoski teaches an intramedullary nail (10, see fig. 5 below), comprising: a body (along 12) with a first end (proximal end) and a second end (distal end), the body comprising: a fastening end (36, see fig. 1-5) at the first end of the body and with an insertion opening (86) extending from the first end into the body along a longitudinal axis of the body (see fig. 5 below); a closed end (e.g., solid) at the second end of the body (see para. 87 below); and at least two openings (e.g., 20, 76) positioned oblique to the longitudinal axis of the body between the first end and the second end of the body (see fig. 5 below).
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Czartoski does not teach a cap removably engaging the fastening end.
Sohngen, also drawn to intramedullary nails teaches a cap (64) removably engaging the fastening end on an intramedullary nail (see fig. 14 and para. 49) in order to prevent bone ingrowth into the intramedullary nail (see para. 49).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Czartoski to a cap removably engaging the fastening end, in view of Sohngen, in order to prevent bone ingrowth into the intramedullary nail.
As for claim 2, Czartoski, as modified by Sohngen, further teaches the intramedullary nail of claim 1, wherein the fastening end, further comprises: a first fastening segment extending away from the body a first distance (see fig. 4 below); a second fastening segment extending away from the body a second distance (see fig. 4 below), wherein the first distance is greater than the second distance (see fig. 4 below); and an engagement opening (26) extending from the first end through the body to an exterior surface (see figs. 1 and 4 below), and wherein a portion of the engagement opening overlaps with the insertion opening (see para. 108 below, fig. 5 above).
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Claim(s) 3 and 4 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Czartoski (US 20070123873) and Sohngen (US 20020151898), as applied to claim 1 above, in view of Siravo (US 20050277936).
As for claims 3 and 4, Czartoski, as modified by Sohngen, does not appear to teach wherein the at least two openings comprises four openings extending through the body on independent planes and angularly spaced apart; and wherein the at least two openings comprises: three first openings; and a second elongated opening.
Siravo, also drawn intramedullary nails, teaches a plurality of oblique openings (e.g. 111, 120, 121, 130, 140) extending through the body on independent planes and angularly spaced apart (see para. 24 and 26); and wherein the at least two openings comprises: three first openings (e.g. 120, 121, 130); and a second elongated opening (140) (see para. 24 above) in order to provide a plurality of angled fixation points that will ensure greater stability by securing the nail to bone in different planes (see para. 26).
It would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Czartoski, as modified by Sohngen, wherein the at least two openings comprises four openings extending through the body on independent planes and angularly spaced apart; and wherein the at least two openings comprises: three first openings; and a second elongated opening, in view of Siravo, in order to provide a plurality of angled fixation points that will ensure greater stability by securing the nail to bone in different planes.
Claim(s) 5 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Czartoski (US 20070123873) and Sohngen (US 20020151898), as applied to claim 1 above, in view of Siravo (US 20050277936) and further in view of Comte (US 4875475).
As for claim 5, Czartoski, as modified by Sohngen, further teaches the intramedullary nail further comprising: a plurality of fasteners (e.g. 38, 58, 82, 84- see Czartoski fig. 2 above), wherein two fasteners of the plurality of fasteners engage the at least two openings of the body (see Czartoski fig. 2 above).
Czartoski, as modified by Sohngen, does not appear to teach wherein the insertion opening of the fastening end engages a second elongated opening of the at least two openings; and a cam member sized to engage the insertion opening and the second elongated opening to translate a fastener of the plurality of fasteners inserted through the second elongated opening along the second elongated opening.
Siravo, also drawn intramedullary nails, teaches a second elongated opening (140) (see para. 24 above) in order to provide a plurality of known screw fixation points that will ensure greater stability by securing the nail to bone in different planes (see para. 26).
It would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Czartoski, as modified by Sohngen, to include a second elongated opening of the at least two openings, in view of Siravo, in order to provide a plurality of known screw fixation points that will ensure greater stability by securing the nail to bone in different planes.
Comte, also drawn to intramedullary nails, teaches wherein the insertion opening (e.g. 11h, 211h- see fig. 1, 2 and 6 below) of the fastening end engages the second elongated opening (see fig. 1, 2 and 6 below); and a cam member sized to engage the insertion opening and the second elongated opening to translate a fastener of the plurality of fasteners inserted through the second elongated opening along the second elongated opening (see fig. 1, 2 and 6 below and also col. 8 lines 22-35 below) in order to micro adjust the fastener and provide the desired compression and fixation to bone.
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It would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Czartoski, as modified by Sohngen and Siravo, wherein the insertion opening of the fastening end engages the second elongated opening; and a cam member sized to engage the insertion opening and the second elongated opening to translate a fastener of the plurality of fasteners inserted through the second elongated opening along the second elongated opening, in view of Comte, in order to micro adjust the fastener and provide the desired compression and fixation to bone.
Claim(s) 6-12 and 16 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Czartoski (US 20070123873) and Sohngen (US 20020151898), as applied to claim 2 above, in view of Klockow (WO 0019925A1).
As for claim 6-12 and 16, Czartoski, as modified by Sohngen, does not teach wherein the cap comprises: an opening extending into the cap from a first end; and an exterior surface surrounding the opening; wherein the opening is threaded; wherein the fastening end further comprises: a threaded portion positioned on an exterior surface of the body; wherein the threaded portion surrounds the insertion opening; wherein the threads of the opening of the cap engage the threaded portion of the fastening end; wherein the cap is removably threaded onto the fastening end of the body and covers at least one end of the insertion opening; wherein the threaded portion is positioned adjacent the insertion opening and the engagement opening; wherein the fastening end further comprises: a threaded portion positioned on an exterior surface of the body, wherein the threaded portion is disposed only on an exterior surface of the first fastening segment; wherein the fastening end further comprises: a threaded portion positioned on an exterior surface of the body, wherein the threaded portion is disposed only on an exterior surface of the second fastening segment; and wherein the cap has an internal thread.
Klockow, also drawn to intramedullary nails (see fig. 1-3 and the abstract below), teaches an end cap (4) attached onto the proximal end of the intramedullary nail (see fig. 1-3 below), specifically, wherein the cap comprises: an opening (e.g., to receive the fastening proximal end of the intramedullary nail, see fig. 1-3 and page 2 below) extending into the cap from a first end (see fig. 3 below); and an exterior surface surrounding the opening (see fig. 2-3 below); wherein the opening is threaded (se 6, see fig. 1-3, page 2 and the abstract below); wherein the fastening end further comprises: a threaded portion (2) positioned on an exterior surface of the body (see fig. 1, page 2 and abstract below); wherein the threaded portion surrounds the insertion opening (see fig. 3 below); wherein the threads of the opening of the cap engage the threaded portion of the fastening end (see page 2, and fig. 1-3 below); wherein the cap is removably threaded onto the fastening end of the body and covers at least one end of the insertion opening (see fig, 1-3 below); wherein the threaded portion is positioned adjacent the insertion opening and the engagement opening (e.g., bone screw opening) (see fig. 1-3 below); and wherein the cap has an internal thread (6) in order to provide an alternate equivalent mechanical connection mechanism to secure the intramedullary nail and end cap together that provides the additional benefit of preventing welding between the end cap and intramedullary nail (see abstract, page 2 and fig. 1-3 below).
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It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the end cap of Czartoski, as modified by Sohngen, wherein the cap comprises: an opening extending into the cap from a first end; and an exterior surface surrounding the opening; wherein the opening is threaded; wherein the fastening end further comprises: a threaded portion positioned on an exterior surface of the body; wherein the threaded portion surrounds the insertion opening; wherein the threads of the opening of the cap engage the threaded portion of the fastening end; wherein the cap is removably threaded onto the fastening end of the body and covers at least one end of the insertion opening; wherein the threaded portion is positioned adjacent the insertion opening and the engagement opening; and wherein the cap has an internal thread, in view of Klockow, in order to provide an alternate equivalent mechanical connection mechanism to secure the intramedullary nail and end cap together that provides the additional benefit of preventing welding between the end cap and intramedullary nail.
Claim(s) 13-15 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Czartoski (US 20070123873) and Sohngen (US 20020151898), as applied to claim 2 above, in view of Klockow (WO 0019925A1) and further in view of Haidukewych (US 20090248025).
As for claims 13-15, Czartoski, as modified by Sohngen, does not teach wherein the fastening end further comprises: a threaded portion positioned on an exterior surface of the body, wherein the threaded portion is disposed on at least a portion of an exterior surface of the first fastening segment and at least a portion of an exterior surface of the second fastening segment; wherein the fastening end further comprises: a threaded portion positioned on an exterior surface of the body, wherein the threaded portion is disposed only on an exterior surface of the first fastening segment; wherein the fastening end further comprises: a threaded portion positioned on an exterior surface of the body, wherein the threaded portion is disposed only on an exterior surface of the second fastening segment.
Klockow, also drawn to intramedullary nails (see fig. 1-3 above), teaches wherein the fastening end further comprises: a threaded portion (2) positioned on an exterior surface of the body in order to provide an alternate equivalent mechanical connection mechanism to secure the intramedullary nail and end cap together that provides the additional benefit of preventing welding between the end cap and intramedullary nail (see page 2, fig. 1-3 and the abstract above).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Czartoksi, as modified by Sohngen, wherein the fastening end further comprises: a threaded portion positioned on an exterior surface of the body, in view of Klockow, as a matter of engineering design choice, in order to provide an alternate equivalent mechanical connection mechanism to secure the intramedullary nail and end cap together that provides the additional benefit of preventing welding between the end cap and intramedullary nail.
Haidukewych, also drawn to intramedullary implants, teaches threaded connection between two elements (e.g., 112 and 114) wherein one of the elements (e.g., 112) may be fully or partially threaded (at 146), as a matter of engineering design choice, in order to provide an alternate equivalent mechanical coupling that provides the same result of securement between the elements (see para. 34-36).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Czartoski, as modified by Sohngen and Klockow, wherein the threaded portion is disposed on at least a portion of an exterior surface of the first fastening segment and at least a portion of an exterior surface of the second fastening segment; wherein the threaded portion is disposed only on an exterior surface of the first fastening segment; and wherein the threaded portion is disposed only on an exterior surface of the second fastening segment, in view of Haidukewych, as a matter of engineering design choice, in order to provide an alternate equivalent mechanical coupling that provides the same result of securement between the elements.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Tara Carter whose telephone number is (571) 272-3402. The examiner can normally be reached on M-F 7am-3pm.
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, please contact the examiner’s supervisor, Eduardo Robert, 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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/TARA ROSE E CARTER/Examiner, Art Unit 3773
/JULIANNA N HARVEY/Primary Examiner, Art Unit 3773
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