DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the claims at issue are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); and In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claim(s) 1 and 10 is/are rejected on the ground of nonstatutory double patenting as being anticipated by claim(s) 1-21 of U.S. Patent No. 9907562. Although the claims at issue are not identical, they are not patentably distinct from each other because the difference between the application claims and the patent claims lies in the fact that the patent claims include many more elements and are thus much more specific as shown below (note that underlined and/or bolded sections indicate comparable elements):
Invention 19/024392
US Patent 9907562
1. A fixation guide device for positioning and inserting an intramedullary nail, comprising: a frame including a first end and a second end; a compression device removably coupled to the first end of the frame; wherein the compression device comprises: a compression member, wherein the compression member comprises: a base with a top end and a bottom end; a protrusion positioned near the bottom end; a first opening positioned near the top end; and a second opening positioned near the bottom end and extending through the base and the protrusion, wherein the second opening slidingly couples to the nail attachment apparatus of the first arm of the frame; a knob; a bolt with a first end and a second end, wherein the bolt rotatably engages the
compression member at the first end and is secured to the knob at the second end, and the bolt extends through and rotatably couples to the first opening in the first arm of the frame; and the intramedullary nail secured to a nail attachment apparatus of the frame.
Claims 1-21:
1. A fixation guide device for positioning and inserting an intramedullary nail, comprising:
a frame including a first end and a second end, wherein the frame comprises: at least one drill hole; and a first arm, comprising:
a first opening; a second opening below and spaced apart from the first opening; and a nail attachment apparatus extending away from the first arm and aligned with the second opening; a compression device removably coupled to the first end of the frame, wherein the compression device comprises: a compression member, wherein the compression member comprises: a base with a top end and a bottom end; a protrusion positioned near the bottom end; a first opening positioned near the top end; and a second opening positioned near the bottom end and extending through the base and the protrusion, wherein the second opening slidingly couples to the nail attachment apparatus of the first arm of the frame; a bolt with a first end and a second end; and a knob, wherein the knob comprises: a first opening for receiving the bolt; a second opening relatively perpendicular to the first opening and extending into the first opening for receiving a fastener; and a plurality of ridges on an exterior surface of the knob; wherein the bolt rotatably engages the compression member at the first end and is secured to the knob at the second end, and the bolt extends though and rotatably couples to the first opening in the first arm of the frame; and wherein the intramedullary nail is secured to the nail attachment apparatus of the frame.
10. An intramedullary nail, comprising: a body with a first end and a second end, the body comprising: a fastening end at the first end of the body and with an insertion opening extending from the first end into the body along a longitudinal axis of the body; a closed end at the second end of the body; and at least two first openings positioned oblique to the longitudinal axis of the body between the first end and the second end of the body; and a second elongated opening, wherein the second elongated opening is elongated along the longitudinal axis of the body and wherein the insertion opening extends into and through the second elongated opening.
Claim 10:
10. A fixation guide device for positioning and inserting an intramedullary nail, comprising:
a frame including a first end and a second end, wherein the frame comprises: at least one drill hole; and a first arm, comprising:
a first opening; a second opening below and spaced apart from the first opening; and a nail attachment apparatus extending away from the first arm and aligned with the second opening; a compression device removably coupled to the first end of the frame, wherein the compression device comprises: a compression member, wherein the compression member comprises: a base with a top end and a bottom end; a protrusion positioned near the bottom end; a first opening positioned near the top end; and a second opening positioned near the bottom end and extending through the base and the protrusion, wherein the second opening slidingly couples to the nail attachment apparatus of the first arm of the frame; a bolt with a first end and a second end; and a knob, wherein the knob comprises: a first opening for receiving the bolt; a second opening relatively perpendicular to the first opening and extending into the first opening for receiving a fastener; and a plurality of ridges on an exterior surface of the knob; wherein the bolt rotatably engages the compression member at the first end and is secured to the knob at the second end, and the bolt extends though and rotatably couples to the first opening in the first arm of the frame; and wherein the intramedullary nail is secured to the nail attachment apparatus of the frame; wherein the nail attachment apparatus comprises a first nail attachment segment extending away from the first arm a first distance; and a second nail attachment segment extending away from the first arm a second distance, wherein the first distance is greater than the second distance; wherein the intramedullary nail comprises: a body with a first end and a second end; at least two openings positioned oblique to a longitudinal axis of the body between the first end and the second end; and a fastening end with at least one opening extending from the second end into the body along the longitudinal axis of the body; wherein the body of the intramedullary nail further comprises a fastening end at the first end of the body with an insertion opening extending from the first end into the body along a longitudinal axis of the body; and a closed end at the second end of the body; wherein the at least two openings comprises four openings extending through the body on independent planes angularly spaced apart; wherein the at least two openings comprises: three first openings; and a second elongate opening; wherein the insertion opening of the fastening end engages the second elongate opening.
Claim(s) 10-13 is/are rejected on the ground of nonstatutory double patenting as being anticipated by claim(s) 1-17 of U.S. Patent No. 11179166. Although the claims at issue are not identical, they are not patentably distinct from each other because the difference between the application claims and the patent claims lies in the fact that the patent claims include many more elements and are thus much more specific as shown below (note that underlined and/or bolded sections indicate comparable elements):
Invention 19/024392
US Patent 11179166
10. An intramedullary nail, comprising: a body with a first end and a second end, the body comprising: a fastening end at the first end of the body and with an insertion opening extending from the first end into the body along a longitudinal axis of the body; a closed end at the second end of the body; and at least two openings positioned oblique to the longitudinal axis of the body between the first end and the second end of the body; and a second elongated opening, wherein the second elongated opening is elongated along the longitudinal axis of the body and wherein the insertion opening extends into and through the second elongated opening.
Claims 1-17:
1. An intramedullary nail, comprising: a body with a first end and a second end, the body comprising: a fastening end at the first end of the body, wherein the fastening end comprises: a first fastening segment extending away from the first end of the body a first distance along a longitudinal axis; and a second fastening segment extending away from the first end of the body a second distance along the longitudinal axis, wherein the first distance is greater than the second distance and wherein the first fastening segment is offset from the second fastening segment along the longitudinal axis; an insertion opening extending from the first end into the body along the longitudinal axis of the body; and an engagement opening extending from the first end through the body to an exterior surface, wherein a portion of the engagement opening overlaps with a portion of the insertion opening to form an oblique opening at the first end of the body that extends between the first fastening segment and the second fastening segment, and wherein the oblique opening intersects and overlaps the longitudinal axis at the first end; a closed end at the second end of the body; and at least two openings positioned oblique to the longitudinal axis of the body between the first end and the second end of the body, wherein the at least two openings comprises: three first openings; and a second elongated opening, wherein the insertion opening of the fastening end engages the second elongated opening.
11. The intramedullary nail of claim 10, wherein the fastening end further comprises: a first fastening segment extending away from the body a first distance; a second fastening segment extending away from the body a second distance, wherein the first distance is greater than the second distance; and an engagement opening extending from the first end through the body to an exterior surface and wherein a portion of the engagement opening overlaps with the insertion opening.
Claims 1-17, see bolded sections of claim 1 above
12. The intramedullary nail of claim 10, wherein the at least two openings comprise four openings extending through the body on independent planes and angularly spaced apart, and, wherein the at least two openings comprise: three first openings; and a second elongated opening.
Claim 2 (also see bolded section of claim 1 above which corresponds to bolded section indicated in claim 12 of the invention):
2. The intramedullary nail of claim 1, wherein the at least two openings comprise four openings extending through the body on independent planes and angularly spaced apart.
13. The intramedullary nail of claim 14, further comprising: a plurality of fasteners, wherein two fasteners of the plurality of fasteners engage the at least two openings of the body; 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; and wherein the insertion opening of the fastening end engages the second elongated opening.
Claim 4:
4. The intramedullary nail of claim 1, further comprising: a plurality of fasteners, wherein two fasteners of the plurality of fasteners engage the at least two openings of the body; 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; and wherein the insertion opening of the fastening end engages the second elongated opening.
Thus, the invention of US Patent 9907562, claims 1-21; US Patent 11179166, claims 1-17, respectively, are in effect a “species” of the “generic” invention of the application claims. It has been held that the generic invention is “anticipated” by the “species”. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993). Since the application claims are anticipated by the patent claims, they are not patentably distinct from the patent claims.
Claim Rejections - 35 USC § 112
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, 2 and 4-9 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.
Claim 1 recites the limitation "the nail attachment apparatus" in lines 11-12. There is insufficient antecedent basis for this limitation in the claim.
Claim 1 recites the limitation "the first arm of the frame" in line 12. There is insufficient antecedent basis for this limitation in the claim.
Claim 1 recites the limitation "the first opening in the first arm of the frame" in lines 16-17. As written, it appears that this limitation is made to a first opening in the first arm of the frame and not the “first opening” of the compression member. There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of pre-AIA 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claim(s) 20 is/are rejected under pre-AIA 35 U.S.C. 102b as being anticipated by Perry (US 5766174).
With respect to claim 20, Perry teaches a method of inserting an intramedullary nail (20) into two bones (e.g., acromion/humerus or separated fractured bony parts of humerus) for fixation of the two bones (see fig. 1), comprising: creating an incision near the two bones (see col. 5 lines 27-29); preparing the two bones for fixation (see col. 5 lines 27-39); securing an alignment guide (56) to the two bones (via the intramedullary nail) to position a guidewire across the two bone (see col. 5 lines 27-39 and 45-52); drilling over the guidewire to create a cavity for the intramedullary nail that passes through the two bones (see col. 5 lines 27-39), wherein the intramedullary nail includes a securing screw hole (e.g., 32a) at a first end (see fig. 3 below) of the intramedullary nail and at least two peg holes (e.g., 34a, 34b); removing the alignment guide from the two bones (i.e., from surgical site at the end of the procedure, see col. 6 lines 8-13); obtaining a fixation guide device (24), wherein the fixation guide device includes a frame (e.g., body of 24) with at least two drill holes (e.g., 42a, 42b) and a compression device (e.g., 48); attaching the intramedullary nail to the compression device of the fixation guide device (see fig. 3 below); inserting the intramedullary nail into the cavity (see fig. 1); inserting a drill sleeve (29) into a first drill hole (e.g., 42a) at a second end (25) of the fixation guide device and drilling a first opening (see col. 5 lines 53-65) that aligns with a first peg hole (34a) in the second end (e.g., at stem) of the intramedullary nail (see fig. 3 below and col. 5 lines 53-65); inserting a first peg (e.g., transfixation screw, see col. 5 line 60) into the first opening and through the first peg hole (see col. 5 lines 57-60); using the first peg and compression device to compress the two bones (see fig. 1); inserting the drill sleeve into a second drill hole (40a) at a first end (see fig. 3 below) of the fixation guide device and drilling a second opening that mates with a second peg hole (32a) in the first end of the intramedullary nail (see fig. 3 below); inserting a second peg (e.g., transfixation screw) into the second opening and through the second peg hole to secure the two bones in compression (see col. 4 lines 13-30); detaching the intramedullary nail from the fixation guide and removing the fixation guide device (see col. 6 lines 5-13); inserting a locking screw (e.g., transfixation screw) into the securing screw hole (see col. 5 line 65 – col. 6 line 4); and closing the incision (see col. 6 lines 5-12).
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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.
Claims 10, 12 and 13 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Siravo (US 20050277936) in view of Corneille (US 20120221005), and in further in view of Comte (US 4875475).
With respect to claims 10, 12 and 13, Siravo, teaches an intramedullary nail (see fig. 1), comprising: a body (see fig. 1) with a first end (e.g., proximal end 105) and a second end (e.g., distal end, at 112), the body comprising: a fastening end (e.g., for a tool) at the first end of the body and with an insertion opening (e.g., 160) extending from the first end into the body along a longitudinal axis of the body (see fig. 3); and at least two first openings (e.g., any of 130, 120, 121, 140, 11) positioned oblique to the longitudinal axis of the body between the first end and the second end of the body (see para. 24, 26); wherein the at least two first openings comprise three first openings (see fig. 1 below); further comprising a plurality of fasteners, wherein two fasteners of the plurality of fasteners engage the at least two first openings of the body (see para. 24).
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Siravo does not teach a closed end at the second end of the body; a second elongated opening, wherein the second elongated opening is elongated along the longitudinal axis of the body and wherein the insertion opening extends into and through the second elongated opening; and a cam member sized to engage the insertion opening and at least a portion of the second elongated opening to translate a fastener of the plurality of fasteners inserted through the second elongated opening along the second elongated opening.
Corneille, also drawn to an intramedullary nail (130), teaches a closed end (see para. 43) at the second end of the body (at 136) as a matter of engineering design choice in order to provide an alternate equivalent design to a fully cannulated intramedullary nail (see para. 43).
It would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Siravo such that there is a closed end at the second end of the body, in view of Corneille, as a matter of engineering design choice in order to provide an alternate equivalent design to a fully cannulated intramedullary nail.
Comte, also drawn to intramedullary nails, teaches a cam member (see fig. 6 below) sized to engage an insertion opening (see fig. 6 below) and a second elongated opening (see fig. 6 below) to translate a fastener (e.g., 215) of the plurality of fasteners inserted through a second elongated opening along the second elongated opening (see fig. 6 below, fig. 1, 2 and also col. 8 lines 22-35); and wherein the insertion opening of the fastening end engages the second elongated opening (see fig. 6 below and col. 8 lines 22-35) in order to micro adjust the fastener and provide the desired compression and fixation to bone (see col. 8 lines 23-25).
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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 Siravo, to include a second elongated opening, wherein the second elongated opening is elongated along the longitudinal axis of the body and wherein the insertion opening extends into and through the second elongated opening; and a cam member sized to engage the insertion opening and at least a portion of 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 11 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Siravo (US 20050277936), Corneille (US 20120221005) and Comte (US 4875475), as applied to claim 10 above, in view of Chapman (US 5066296).
Siravo, as modified by Corneille and Comte, does not teach a first fastening segment extending away from the body a first distance; a second fastening segment extending away from the body a second distance, wherein the first distance is greater than the second distance; and an engagement opening extending from the first end through the body to an exterior surface and wherein a portion of the engagement opening overlaps with the insertion opening.
Chapman, also drawn to intramedullary nails, teaches the addition of a locking tab member (14) that specifically includes a first fastening segment extending away from the first end of the body (16) a first distance along the longitudinal axis (see fig. 2 below); and a second fastening segment extending away from the first end of the body (16) a second distance along the longitudinal axis, wherein the first distance is greater than the second distance (see fig. 2 below) and wherein the first fastening segment is offset from the second fastening segment along the longitudinal axis (see fig. 2 below); and wherein the oblique opening extends between the first fastening segment and the second fastening segment (see fig. 2 below) in order to provide a known locking mechanical coupling member that prevents backout of the intramedullary nail from the intramedullary canal while reducing rotational stresses at the surgical site (see col. 5 lines 40-46).
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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 Siravo, as modified by Corneille and Comte, to include a first fastening segment extending away from the body a first distance; a second fastening segment extending away from the body a second distance, wherein the first distance is greater than the second distance; and an engagement opening extending from the first end through the body to an exterior surface and wherein a portion of the engagement opening overlaps with the insertion opening, in view of Chapman, in order to provide a known locking mechanical coupling member that prevents backout of the intramedullary nail from the intramedullary canal while reducing rotational stresses at the surgical site.
Reasons for Allowance
The following is a statement of reasons for the indication of allowable subject matter:
The claims in the instant application have not been rejected using prior art because no references, or reasonable combination thereof, could be found which disclose, or suggest, the claimed combination of limitations recited in claim 1. None of the cited references teach or suggest the second opening extending through the base and the protrusion, as required by claims 1, 2 and 4-9.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Response to Arguments
The 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph rejections made to claims 13 and 20 are withdrawn in response to the amendment entered on 7/21/2026.
The Double Patenting rejection made to claims 1 and 10-13 has been updated to reflect the amendment entered on 7/21/2026.
Applicant presents arguments regarding the combination of Edwards and Ritchey as applied to claim 1 (see Remarks page 13). The amendment entered on 7/21/2026 adds the content of previously pending claim 3 into claim 1. While Edwards teaches a fixation guide device (see para. 53) for positioning and inserting an intramedullary nail (see fig. 7a below), comprising: a frame (52) including a first end and a second end (e.g., proximal and distal ends, see fig. 7a below and para. 55); a compression device (14) removably coupled to the first end of the frame (note that 16 is attached at 53, see paras. 44, 48 and 56 as well as figs. 2a, 4 and 7a below); wherein the compression device comprises: a compression member (24), wherein the compression member comprises: a base (34, 36) with a top end (36) and a bottom end (34, see fig. 1a, 4 below); a protrusion (e.g., 26) positioned near the bottom end (see fig. 1a below); a first opening (60) positioned near the top end (see fig. 1a below); and a second opening (74) positioned near the bottom end, wherein the second opening slidingly couples to the nail attachment apparatus of the first arm of the frame; a knob (e.g., 50, see fig. 7a); a bolt (16) with a first end (44) and a second end (48), wherein the bolt rotatably engages the compression member at the first end (see fig. 5a) and is secured to the knob at the second end (see fig. 4, 5a), and the bolt extends through and rotatably couples to the first opening (e.g., circular void, see para. 56) in the first arm (53) of the frame (see fig. 7a and para. 56); and the intramedullary nail (12) secured to the nail attachment apparatus (79, 78). Edwards does not teach the second opening extending through the base and the protrusion. Ritchie does not provide teaching for a modification resulting in the second opening extending through the base and the protrusion.
The USC 103(a) rejection to claims 1, 2 and 4-9 is withdrawn.
The rejection of claims 10, 12 and 13 has been updated to address the amendment entered on 7/21/2026. Applicant simply states that Siravo, Corneille and Comte do not teach the limitations of claims 10, 12 and 13 (see Remarks pages 13-15). Applicant does not provide any arguments regarding the specific application of Siravo, as modified by Corneille and Comte.
The rejection of claims 10, 12 and 13 is maintained.
The rejection of claim 11 has been updated to address the amendment entered on 7/21/2026.
The rejection of claim 20 has been updated to address the amendment entered on 7/21/2026. Applicant argues that Perry does not teach “removing the alignment guide from the two bones”. This is not found to be persuasive as there is no text within Claim 20 providing an order of operations. As explained in the rejection to claim 20 above, this step is interpreted as occurring at the end of the procedure.
The rejection of claim 20 is maintained.
Allowable Subject Matter
Claims 2 and 4-9 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
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.
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/TARA ROSE E CARTER/Examiner, Art Unit 3773
/JAN CHRISTOPHER L MERENE/Primary Examiner, Art Unit 3773
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