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 .
Response to Amendment
According to the amendment filed November 11, 2025, claim 1 has been amended. Claims 1-2, 4-9, 11-13, 15 and 17-20 are currently pending in this application, where claims 17-20 remain withdrawn from consideration.
Response to Arguments
Applicant's arguments, see page 2 of Remarks filed November 11, 2025, regarding the rejection of independent claims 1 and 11 under 35 U.S.C. 103 as unpatentable over de la Caffiniere ‘200 (EP 0919200 A1), de la Caffiniere ‘947 (FR 2718947 A) and O’Reilly (US 2010/0152740 A1), have been fully considered but they are not persuasive.
Applicant asserts that the cited references do not teach or suggest where the second fastener stabilizes the first fastener in a non-threaded engagement that allows for non-threaded movement therebetween, as required by the claims. Specifically, Applicant states that “De la Caffiniere, as best understood, shows a sighting device for driving nails and screws to repair a broken femur, with no movement possible between the fasteners” and “O’Reilly uses a set screw 34 to the same effect”.
Examiner respectfully disagrees and notes that it is unclear which of the two de la Caffiniere references the applicant refers to. As described in the rejection maintained below, the primary reference of de la Caffiniere ‘200 is silent on the configuration of the transverse bore receiving the second fastener, but de la Caffiniere ‘947 specifically teaches a second fastener received in a transverse bore of a first fastener where the second fastener only has a distal thread, thus providing the claimed non-threaded engagement allowing for non-threaded movement, such movement being necessary at least for inserting the second fastener through the transverse bore (see Figs. 1-2 of de la Caffiniere ‘947). Further, the teachings of O’Reilly are applied in the rejection with respect to the structure of the fixation arm, so that O’Reilly’s set screw is irrelevant to the non-threaded engagement configuration between the first and second fasteners. For at least these reasons, the rejections noted above are maintained, as seen below.
Applicant's arguments fail to comply with 37 CFR 1.111(b) because they amount to a general allegation that the claims define a patentable invention without specifically pointing out how the language of the claims patentably distinguishes them from the references.
Applicant’s arguments, see page 1 of Remarks filed November 11, 2025, with respect to support in the specification for limitations in independent claims 1 and 11 that require the second fastener (or set screw) to have threading and stabilize the first fastener (or fixation screw) in non-threaded engagement that allows for non-threaded movement therebetween have been fully considered and are persuasive. The rejection of claims 1-2, 4-9, 11 and 13-15 under 35 U.S.C. 112(a) has been withdrawn.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-2, 5-9, 11 and 13-15 are rejected under 35 U.S.C. 103 as being unpatentable over EP 0919200 A1 to de la Caffiniere (hereinafter “de la Caffiniere ‘200”) in view of FR 2718947 A1 to de la Caffiniere (hereinafter “de la Caffiniere ‘947”) and US 2010/0152740 A1 to O’Reilly. Note that parenthetical citations to de la Caffiniere ‘200 and de la Caffiniere ‘947 are taken from the English language translation provided the Office Action mailed August 11, 2025.
Regarding claim 1, de la Caffiniere ‘200 teaches a bone fixation device for treatment of a bone fracture, comprising:
a first fastener (20; Fig. 6; para. 0038) defining a transverse opening (lumen 21, for receiving intermediate transfixing screw 26; Figs. 2, 5-6; para. 0032);
a fixation arm (lower branch 40; Figs. 3A, 6) configured for inserting the first fastener through a bone fracture (shown for inserting first fastener 20 through aiming means/opening 42; Fig. 6; para. 0005, 0036; claim 16)
a second fastener (26; Figs. 2, 5; para. 0032); and
an aiming arm (upper branch 50; Figs. 3A, 6) configured for inserting the second fastener into the transverse opening and engagement with the first fastener (as shown for inserting second fastener 26 into transverse opening 21 of the first fastener via an opening 51 formed in the aiming arm; Figs. 3A, 5-6);
wherein the second fastener (20; Fig. 5) stabilizes the first fastener (26, as shown; Fig. 5) and the second fastener is configured with threading to engage the bone (second fastener/screw 26 is understood to have threading and shown engaging the bone in at least Fig. 5).
Examiner notes that de la Caffiniere ‘200 is silent on the configuration of the internal surface of the transverse opening, and does not explicitly disclose that (I) the second fastener stabilizes the first fastener in a non-threaded engagement, nor does de la Caffiniere teach (II) wherein the fixation arm comprises a rotatable shaft; wherein the first fastener is a fixation screw, and is rotationally affixed to an end of the rotatable shaft; and (III) wherein the fixation arm further comprises a shroud having a substantially tubular body that houses the shaft, the rotatable shaft being configured to rotate within the shroud.
(I) Regarding the non-threaded engagement between the first and second fastener, de la Caffiniere ‘947 discloses a similar bone fixation device for a bone fracture (see Figs. 1-4; para. 0001) comprising a first fastener (nail A; Figs. 1-4) defining a transverse opening (channel 1; Figs. 1-4) and a second fastener (fixing screw II; Figs. 1-2), wherein the second fastener stabilizes the first fastener in a non-threaded engagement that allows for non-threaded movement therebetween, and the second fastener is configured with threading to engage the bone (para. 0003 recites that the second fastener, i.e. locking screw II, only has a distal thread 4, so that the non-threaded segment 5 within transverse opening 1 stabilizes the first fastener A in non-threaded engagement, as shown in Fig. 2, allowing for non-threaded movement therebetween, and distal thread 4 is configured to engage bone as shown in Fig. 1).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the first fastener disclosed by de la Caffiniere ‘200 (i.e., the screw 26 in Fig. 5) to comprise only a distal thread as taught by de la Caffiniere ‘947, so that the second fastener stabilizes the first fastener in a non-threaded engagement and continues to comprise threading for engaging the bone, as claimed, because de la Caffiniere ‘947 recognizes this as a suitable second fastener configuration for operably stabilizing a first fastener having the claimed structures and engagement, and such non-threaded engagement within the transverse bore (see Figs. 1-4 and paragraph 0003 of de la Caffiniere ‘947).
(II) Regarding the fixation arm comprising a rotatable shaft, and the first fastener being a fixation screw rotationally affixed to an end of the rotatable shaft, O’Reilly is considered analogous to the claimed invention because it is directed towards a bone fixation device for treatment of a femoral fracture (see Figs. 1 and 18-22; para. 0072, 0117), and teaches the device including a first fastener in the form of a fixation screw (18/18A; Figs. 18-22), and an inserter device (400; Figs. 18-22; para. 0118) configured for inserting the fixation screw through a bone fracture (see Figs. 18-22; para. 0118-0128). O’Reilly also teaches wherein the inserter device (400; Fig. 19) comprises a rotatable shaft (defined by inner shaft member 406 and inserter shaft 404, each selectably coupled with each other and with the head 424 of the fixation screw 18a, as shown in Fig. 19, such that simultaneous rotation of the shaft assembly causes rotation of the fixation screw 18a to install it through a fracture; Figs. 18-22; para. 0118-0128), wherein the fixation screw (18a; Figs. 19-20) is rotationally affixed to an end of the shaft such that rotation of the shaft rotates the fixation screw (as described above and best shown in Figs. 18-20 and 22).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have incorporated distal threads on the fixation device of de la Caffiniere ‘200, as taught by O’Reilly, thus providing a modified fixation screw with the transverse opening, and to have incorporated O’Reilly’s inserter device and rotatable shaft with the fixation arm of de la Caffiniere ‘200, i.e. by placing O’Reilly’s inserter device through the guiding aperture in the fixation arm, so that the modified first fastener (fixation screw) is rotationally affixed to an end of the shaft to rotate the fixation screw as claimed, because O’Reilly teaches that a fixation screw placed through a fracture the femoral neck/head region is suitable for coupling the fixation device with the corresponding anatomy without necessarily requiring the formation of a pre-tapped bore (see O’Reilly, para. 0126), and O’Reilly also teaches that an inserter instrument having a rotatable shaft configured and operable in the claimed manner aids in installing such a fixation screw (see O’Reilly, Figs. 18-22).
(III) Regarding the tubular shroud housing the rotatable shaft, where de la Caffiniere ‘200 does teach wherein the aiming arm (50; Fig. 3A) comprises a shroud (52; Fig. 3A; para. 0036) having a substantially tubular body that is capable of housing a shaft (tube 52 shown in Fig. 3A defines a shroud that extends upward from the aiming arm 50 and is provided to guide “specific ancillary means to correctly position a screw”; para. 0036), it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the fixation arm of de la Caffiniere ‘200 to include a shroud located around the guide opening formed in the fixation arm (i.e., at opening 42 shown in Fig. 3A of de la Caffiniere ‘200), so that O’Reilly’s rotatable shaft of the inserter assembly is configured to rotate within the shroud to install the first fastener/fixation screw through the femoral fracture, because de la Caffiniere ‘200 teaches a similar shroud provided on the aiming arm, as described above, and notes that such a structure aids in guiding and positioning insertion tool(s) for installing a corresponding screw in anatomy (see de la Caffiniere ‘200, Fig. 3A and para. 0036).
Regarding claim 2, the combined teachings of de la Caffiniere ‘200, de la Caffiniere ‘947 and O’Reilly teach the fixation device of claim 1, and de la Caffiniere ‘200 teaches wherein the fixation arm is configured for inserting the first fastener at a first angle, and the aiming arm is configured for inserting the second fastener at a second angle, substantially perpendicular to the first angle (fixation arm 40 is configured for inserting the first fastener 20 through opening 42 at a first angle defined along an axis of opening 42, and aiming arm 50 is configured for inserting a second fastener 26 through opening 51 at a second angle defined along an axis of opening 51, shown in Fig. 3A to be perpendicular to the first angle).
Regarding claim 5, the combined teachings of de la Caffiniere ‘200, de la Caffiniere ‘947 and O’Reilly teach the fixation device of claim 1.
The combination described above does not specifically teach wherein the first fastener defines an axially extending cannula configured to receive a Kirschner wire.
However, O’Reilly teaches the device for treatment of a femoral fracture (see Figs. 1 and 18-22; para. 0072, 0117) including a first fastener in the form of a fixation screw (18/18A; Figs. 18-22) that defines an axially extending cannula (442; Figs. 20-21) configured to receive a Kirschner wire (see para. 0126: through bore 422 “sized to enable the reconstructive screw 18a to slidably engage a guidewire” not specifically shown, or to enable other instruments, not shown, to be inserted into an anatomy via the screw insertion instrument 400).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention modified the first fastener of de la Caffiniere ‘200 to have distal threads and a cannula for receiving a Kirschner wire, as taught by O’Reilly, thus providing a modified first fastener satisfying the claim limitations, because O’Reilly teaches that a such a fastener configuration for placement through a fracture the femoral neck/head region is suitable for coupling the fixation device with the corresponding anatomy without necessarily requiring the formation of a pre-tapped bore, where the axially extending cannula for receiving a Kirschner wire aids in properly placing the fastener in the corresponding anatomy during installation (see O’Reilly, Figs. 18-22 and para. 0122 and 0126).
Regarding claim 6, the combined teachings of de la Caffiniere ‘200, de la Caffiniere ‘947 and O’Reilly teach the fixation device of claim 1, and de la Caffiniere ‘200 teaches wherein the aiming arm (50; Fig. 6) is affixed to a first end of the fixation arm (as shown in Fig. 6, affixed at the upper/first end of fixation arm 40), and the first fastener (20; Figs. 5-6) is attached to a second end of the fixation arm (see Fig. 6: fastener 20 is operably attached with the lower/second of fixation arm 40, for insertion through guiding opening 42).
Regarding claim 7, the combined teachings of de la Caffiniere ‘200, de la Caffiniere ‘947 and O’Reilly teach the fixation device of claim 6, and de la Caffiniere ‘200 teaches wherein the aiming arm (50; Figs. 3A, 6) comprises a first end affixed to the fixation arm (as shown, first/right end affixed to fixation arm 40 at bevel 54; Fig. 3A; para. 0036), and a second end positioned for aligning the second fastener with the transverse opening (second/left end of aiming arm 50 having tube 52 with opening 51 for aligning second fastener 26 with transverse opening 21 in first fastener 20; Figs. 2, 3A, 5-6).
Regarding claim 8, the combined teachings of de la Caffiniere ‘200, de la Caffiniere ‘947 and O’Reilly teach the fixation device of claim 7, and de la Caffiniere ‘200 teaches wherein the aiming arm (50; Figs. 3A, 6) comprises an elongate aiming guide (tube 52; Fig. 6; para. 0036) that extends over the fixation arm (elongate aiming guide/tube 52 shown to extend above, i.e. over, fixation arm 40; Fig. 6) and is configured for aligning the second fastener (26; Figs. 1-2, 3A, 5-6) with the transverse opening (21, as shown; Figs. 1-2, 3A, 5-6).
Regarding claim 9, the combined teachings of de la Caffiniere ‘200, de la Caffiniere ‘947 and O’Reilly teach the fixation device of claim 8.
De la Caffiniere ‘200 does teach a through hole (51; Fig. 3A) formed in the aiming arm (50) and aligned with the transverse opening (21; Figs. 2, 3A, 5-6; para. 0036), for positioning the second fastener within the transverse opening (as described in para. 0036 and generally shown in Figs. 2, 3A, 5-6).
The combination described above does not specifically disclose the device further comprising a guide sheath that extends through the through hole, the guide sheath having an elongate body that extends towards the first fastener, for positioning the second fastener within the transverse opening.
O’Reilly teaches a guide sleeve (208; Fig. 2B) that extends through a through hole (100; Fig. 2B) of a guide instrument (22; Fig. 2B; para. 0067), the guide sheath having an elongate body for positioning a fastener or instrument (elongate guide sheaths/sleeves 208 are positioned through the guide instrument to enable a surgeon to guide instruments and/or appropriate fasteners through the guide instrument; Fig. 2B; para. 0088-0089).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have included O-Reilly’s guide sheath extending through the through hole (of de la Caffiniere ‘200) for positioning the second fastener within the transverse opening as claimed, because such a configuration further assists in guiding and positioning instrumentation to properly install a fastener, as recognized by O’Reilly (see O’Reilly, para. 0089).
Regarding claim 11, de la Caffiniere ‘200 teaches a bone fixation device for treatment of a femoral neck fracture, located between the femur and femur head regions, the device comprising:
a fixation device (20; Fig. 6; para. 0038) defining a transverse opening (lumen 21, for receiving intermediate transfixing screw 26; Figs. 2, 5-6; para. 0032);
a fixation arm (lower branch 40; Figs. 3A, 6) configured for inserting the fixation device through a femur at a first angle (shown for inserting first fastener 20 through aiming means/opening 42; Fig. 6; para. 0005, 0036; claim 16), the fixation arm having an elongate body including a first end and a second end (as shown, having a first upper end and a second lower end; Fig. 6);
a set screw (26; Figs. 2, 5; para. 0032); and
an aiming arm (upper branch 50; Figs. 3A, 6) configured for inserting the set screw through the femur at a second angle (as shown; Figs. 2, 3A, 5-6), into the transverse opening (21; Figs. 5-6) and engagement with the fixation device (see Figs. 5-6), the aiming arm being affixed to the first end of the fixation arm and extending over the fixation arm to position the set screw in alignment with the transverse opening (as shown attached at the first upper end of fixation arm 40, extending to the left above/over fixation arm 40 as viewed in Fig. 6, to position set screw 26 in the transverse opening 21; Figs. 5-6) wherein the set screw stabilizes the fixation device (see Fig. 5) and the set screw is configured with threading to engage the femur (set screw 26 is understood to have threading and shown engaging the femur in at least Fig. 5).
De la Caffiniere ‘200 also teaches the first fastener having “cylindrical channel” (22 in Fig. 2) at a proximal end of the fastener “intended to receive specific ancillary equipment” (see para. 0032), e.g. for driving/installing the first fastener, and is silent on the configuration of the internal surface of the transverse opening (see description of lumen/light 21 shown in Figs. 5-6 for receiving second fastener/screw 26).
However, de la Caffiniere ‘200 does not disclose wherein: (I) the fixation device is a fixation screw, where the fixation screw releasably affixed at the second end of the body of the fixation arm, and the fixation screw is rotationally affixed to the fixation arm, such that rotation of the fixation arm rotates the fixation screw; wherein the fixation arm comprises a rotatable shaft; (II) the set screw stabilizes the fixation screw in a non-threaded engagement; and (III) the fixation arm further comprises a shroud having a substantially tubular body that houses the shaft, the shaft being configured to rotate within the shroud.
(I) Regarding the fixation device being a screw and the fixation arm comprising a rotatable shaft releasably attached thereto, O’Reilly is considered analogous to the claimed invention because it is directed towards a bone fixation device for treatment of a femoral fracture (see Figs. 1 and 18-22; para. 0072, 0117), the device including a first fastener in the form of a fixation screw (18/18A; Figs. 18-22), and an inserter device (400; Figs. 18-22; para. 0118) configured for inserting the fixation screw through a bone fracture (see Figs. 18-22; para. 0118-0128). O’Reilly also teaches wherein the fixation screw (18a; Figs. 18-22) is releasably affixed to a distal end of the inserter device (as best shown in Fig. 20, inner and outer shafts of the inserter device 400 are releasably coupled with head 424 of fixation screw 18a, so that rotation of the inserter device rotates the fixation screw; Figs. 18-22; para. 0126).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified fixation device of de la Caffiniere ‘200 to have the form of O’Reilly’s analogous fixation screw while maintaining the transverse opening feature, where the fixation screw configured for insertion through a femoral fracture in the claimed manner, and to have further incorporated O’Reilly’s inserter device and rotatable shaft at the lower/second end of the fixation arm of de la Caffiniere ‘200, i.e. by extending O’Reilly’s inserter device through the guiding aperture in the fixation arm of de la Caffiniere ‘200, so that the fixation screw is releasably affixed to the inserter device at the lower/second end of the fixation arm such that rotation of the shaft of the inserter device incorporated with the fixation arm rotates the fixation screw as claimed, because O’Reilly teaches that a fixation screw placed through a fracture the femoral neck/head region is suitable for coupling the fixation device with the corresponding anatomy without necessarily requiring the formation of a pre-tapped bore (see O’Reilly, para. 0126), and O’Reilly also teaches that an inserter instrument having a rotatable shaft configured and operable in the claimed manner aids in installing such a fixation screw (see O’Reilly, Figs. 18-22).
(II) Regarding the non-threaded engagement between the first and second fastener, de la Caffiniere ‘947 discloses a similar bone fixation device for a femoral neck fracture (see Figs. 1-4; para. 0001) comprising a fixation nail (A; Figs. 1-4) defining a transverse opening (channel 1; Figs. 1-4) and a set screw (fixing screw II; Figs. 1-2), wherein the set screw stabilizes the fixation nail in a non-threaded engagement that allows for non-threaded movement therebetween, and the set screw fastener is configured with threading to engage the bone (para. 0003 recites that the set screw II only has a distal thread 4, so that the non-threaded segment 5 within transverse opening 1 stabilizes the first fastener A in non-threaded engagement, as shown in Fig. 2, allowing for non-threaded movement therebetween, and distal thread 4 is configured to engage bone as shown in Fig. 1).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the set screw disclosed by de la Caffiniere ‘200 (i.e., the screw 26 in Fig. 5) to comprise only a distal thread as taught by de la Caffiniere ‘947, so that the modified set screw stabilizes the fixation screw in a non-threaded engagement and continues to comprise threading for engaging the bone, as claimed, because de la Caffiniere ‘947 recognizes this as a suitable set screw configuration for operably stabilizing a fixation screw having the claimed structures and engagement, and such non-threaded engagement within the transverse bore (see Figs. 1-4 and paragraph 0003 of de la Caffiniere ‘947).
(III) Regarding the tubular shroud housing the rotatable shaft, where de la Caffiniere ‘200 teach wherein the aiming arm (50; Fig. 3A) comprises a shroud (52; Fig. 3A; para. 0036) having a substantially tubular body that is capable of housing a shaft (tube 52 shown in Fig. 3A defines a shroud that extends upward from the aiming arm 50 and is provided to guide “specific ancillary means to correctly position a screw”; para. 0036), it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the fixation arm of de la Caffiniere ‘200 to include a shroud located around the guide opening formed in the fixation arm (i.e., at opening 42 shown in Fig. 3A of de la Caffiniere ‘200), so that O’Reilly’s rotatable shaft of the inserter assembly is configured to rotate within the shroud to install the first fastener/fixation screw through the femoral fracture, because de la Caffiniere ‘200 teaches a similar shroud provided on the aiming arm, as described above, and notes that such a structure aids in guiding and positioning insertion tool(s) for installing a corresponding screw in anatomy (see de la Caffiniere ‘200, Fig. 3A and para. 0036).
Regarding claim 13, the combined teachings of de la Caffiniere ‘200, de la Caffiniere ‘947 and O’Reilly teach disclose the bone fixation device of claim 11, wherein the fixation screw defines an axially extending cannula configured to receive a Kirschner wire (in the modification described above with respect to claim 11, the modified fixation screw of de la Caffiniere ‘200 has the structure of O’Reilly’s fixation screw 18a, including through bore 422 shown in Figs. 20-21 of O’Reilly that is “sized to enable the reconstructive screw 18a to slidably engage a guidewire” not specifically shown; see para. 0126 of O’Reilly).
Regarding claim 14, the combined teachings of de la Caffiniere ‘200, de la Caffiniere ‘947 and O’Reilly teach disclose the bone fixation device of claim 11, and de la Caffiniere ‘200 teaches wherein the aiming arm (50; Figs. 3A, 6) comprises an elongate aiming guide (tube 52; Fig. 6; para. 0036) that extends over the fixation arm (elongate aiming guide/tube 52 shown to extend above, i.e. over, fixation arm 40; Fig. 6) and is configured for aligning the second fastener (26; Figs. 1-2, 3A, 5-6) with the transverse opening (21, as shown; Figs. 1-2, 3A, 5-6).
Regarding claim 15, the combined teachings of de la Caffiniere ‘200, de la Caffiniere ‘947 and O’Reilly disclose the bone fixation device of claim 14.
De la Caffiniere ‘200 does teach a through hole (51; Fig. 3A) formed in the aiming arm (50) and aligned with the transverse opening (21; Figs. 2, 3A, 5-6; para. 0036), for positioning the second fastener within the transverse opening (as described in para. 0036 and generally shown in Figs. 2, 3A, 5-6).
In the combination described above, neither de la Caffiniere ‘200, de la Caffiniere ‘947 nor O’Reilly specifically teach the device further comprising a guide sheath that extends through the through hole, the guide sheath having an elongate body that extends towards the first fastener, for positioning the set screw within the transverse opening.
However, in another example, O’Reilly discloses a guide sleeve (208; Fig. 2B) that extends through a through hole (100; Fig. 2B) of a guide instrument (22; Fig. 2B; para. 0067), the guide sheath having an elongate body for positioning a fastener or instrument (elongate guide sheaths/sleeves 208 are positioned through the guide instrument to enable a surgeon to guide instruments and/or appropriate fasteners through the guide instrument; Fig. 2B; para. 0088-0089).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have included O-Reilly’s guide sheath extending through the through hole for positioning the set screw within the transverse opening as claimed, because such a configuration further assists in guiding and positioning instrumentation to properly install a fastener, as recognized by O’Reilly (see O’Reilly, para. 0089).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over EP 0919200 A1 to de la Caffiniere (“de la Caffiniere ‘200”), FR 2718947 A1 to de la Caffiniere (“de la Caffiniere ‘947”) and US 2010/0152740 A1 to O’Reilly, as applied to claim 1 above, further in view of US 2010/0249850 A1 to Cerynik.
Regarding claim 4, the combined teachings of de la Caffiniere ‘200, de la Caffiniere ‘947 and O’Reilly teach the fixation device of claim 1.
The above-cited references do not recite wherein the transverse opening contains a biodegradable material that engages the second fastener.
Cerynik is considered analogous to the claimed invention because it is directed towards a first fastener (12; Fig. 3) having a transverse bore for receiving a second fastener (first fastener body 12 has a transverse opening for receiving a second fastener defined by bone screw 24, which includes distal threading 39 along a portion of a shaft 32; Figs. 3-4; para. 0043-0045), and teaches wherein the transverse opening contains a biodegradable material that engages the second fastener (when second fastener 24 in Fig. 4 is inserted through the opening in first fastener 12, as shown in Fig. 3, bioresorbable material 44 positioned around the shaft 32 of the second fastener 24, adjacent head 38, the bioresorbable material 44 is positioned in the transverse opening and engages second fastener 24; para. 0045).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the transverse opening in the first fastener disclosed by de la Caffiniere ‘200 to contain a biodegradable material for engaging the second fastener, as taught by Cerynik, because Cerynik teaches that incorporating such material in the opening for a fastener aids in initially, rigidly fixing the fastener to the opening and subsequently, upon resorption of the material, enables the angular relation between the fasteners to be no longer rigidly fixed, “thereby effecting a transformation from rigid osteosynthesis to flexible osteosynthesis to allow micromotion between the bone fragments which promotes healing” (see Cerynik, Abstract) and is particularly suited for orthopedic fixation devices for the treatment of bone fractures (see Cerynik, para. 0044).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Other relevant references can be found in the attached PTO-892, including Schreiber (US 2010/0179550 A1) teaching a fastener with a transverse bore receiving a non-threaded fastener or a threaded fastener (see Figs. 1-4, para. 0030) and Hedgeland (US 2018/0078294 A1) teaching a first fastener having a transverse bore for receiving a second fastener having only distal threads (see Figs. 6A-B).
THIS ACTION IS MADE FINAL. 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 ANNA VICTORIA LITTLE whose telephone number is (571)272-6630. The examiner can normally be reached M-F 9a-6p 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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/ANNA V. LITTLE/Examiner, Art Unit 3773 /JACQUELINE T JOHANAS/Primary Patent Examiner, Art Unit 3773