DETAILED ACTION
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.
Claims 6, 9, 12-14, 19, and 22 are rejected under 35 U.S.C. 1023 as being unpatentable over U.S. Patent Application Publication No. 2004/0172026 (Ekholm) in view of U.S. Patent Application Publication No. 2005/0055024 (James) and U.S. Patent Application Publication No. 2009/0182336 (Brenzel).
Regarding claim 6, Ekholm discloses a stabilization system (see Abstract and paragraph [0001]) for stabilizing a bone, the system comprising: an implant (10) having an upper portion (16) defining a first central longitudinal axis (15) and a lower portion (27) defining a second central longitudinal axis (15), the upper portion configured and dimensioned to be cylindrical (see Figs. 1-3) and having a width or diameter greater than the lower portion (see Figs. 1-3 and paragraph [0018]), and the lower portion extending from the upper portion and having a length greater than a length of the upper portion (see marked-up Fig. 1 above), the upper portion and the lower portion including a plurality of holes (30-36 in the upper portion; 42-44 in the lower portion); and a plurality of fasteners (bone screws, see paragraphs [0022] and [0023]) configured to be received by the plurality of holes of the upper and lower portions of the implant (see paragraphs [0022] and [0023]), wherein the lower portion is being capable of being positioned in an intramedullary canal (see paragraph [0023]) and the upper portion is capable of being positioned in a humeral head (see paragraphs [0005], [0007], and [0022]).
Ekholm fails to disclose wherein the second central longitudinal axis is parallel and laterally offset from the first central longitudinal axis, but instead discloses that the axes share the same straight, linear axis (15). However, James discloses an intramedullary nail (100) for use in a humerus (see paragraph [0001]), wherein the intramedullary nail comprises an upper portion (102) and a lower portion (104/106), wherein the upper portion comprises more material on a lateral side of the nail than a medial side of the nail (see paragraphs [0060] and [0061]). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the lateral side of the upper portion of the intramedullary nail of Ekholm to include more material as suggested by James in order to increase the strength and robustness of the proximal portion of the nail, thus increasing rotational stability of the nail, and enhancing resistance to bending and twisting (see James, paragraph [0059]-[0061]). Such a modification would shift the central longitudinal axis of the upper portion laterally relative to the central longitudinal axis of the lower portion such that the central longitudinal axis of the upper portion is laterally offset and parallel to the central longitudinal axis of the lower portion (see marked-up Figs. 1 of Ekholm below).
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Ekholm fails to disclose wherein the upper portion is a hollow mesh cage, wherein the hollow mesh cage has a coarser mesh than a diameter of the plurality of fasteners configured to be received by the upper portion. However, Brenzel discloses a bone stabilization implant (2900) that comprises an upper portion (2904) and a lower portion (2910), wherein the upper portion is a hollow mesh cage (see paragraph [0155] and Fig. 29), wherein the hollow mesh cage has a coarser mesh than a diameter of a plurality of fasteners (2907/2908) configured to be received by the upper portion (see Fig. 29 and paragraph [0306]; see also fastener 1922 inserted through mesh 1912 in Figs. 19 and 20 and paragraphs [0161] and [0362]; anchors can pass through cells in the mesh). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the invention to have the upper portion of Ekholm be a hollow mesh cage coarser than the diameter of fasteners received by the mesh as suggested by Brenzel in order to have the upper portion mimic bone and act as a bone growth or graft scaffold (see paragraph [0155]), thus facilitating fixation of the implant to the adjacent bone, while still allowing for the fixation of the mesh to adjacent bones via fasteners (see paragraphs [0096], [0140]-[0163], and [0362]).
Regarding claim 9, Ekholm discloses wherein the length of the lower portion is greater than a width or diameter of the lower portion (see marked-up Fig. 1 above).
Regarding claim 12, Ekholm discloses wherein the upper portion is configured to be rotated within the humoral head to align the humoral head with the intramedullary canal (see paragraphs [0005], [0007], and [0022]; upper portion capable of being positioned and fixed within the humoral head via bone screws, and thus, can be rotated within the humeral head to align the humoral head with the intramedullary canal).
Regarding claims 13 and 14, Ekholm discloses a humeral stabilization system (see Abstract and paragraph [0001]) for stabilizing a humerus bone, the system comprising: an implant (10) having an upper portion (16) defining a first central longitudinal axis (15) and a lower portion (27) defining a second central longitudinal axis (15), the upper portion is cylindrical (see Figs. 1-3) and is adapted to be received in a head of the humerus (see paragraph [0005], [0007], and [0022]); and the lower portion extends from the upper portion and is adapted to be received in an intramedullary canal of the humerus (see paragraph [0023]), the upper portion and the lower portion including a plurality of holes (30-36 in the upper portion; 42-44 in the lower portion); and a plurality of fasteners (bone screws, see paragraphs [0022] and [0023]) configured to be received by the plurality of holes of the upper and lower portions of the implant (see paragraphs [0022] and [0023]).
Ekholm fails to disclose wherein the second central longitudinal axis is parallel and laterally offset from the first central longitudinal axis, but instead discloses that the axes share the same straight, linear axis (15). However, James discloses an intramedullary nail (100) for use in a humerus (see paragraph [0001]), wherein the intramedullary nail comprises an upper portion (102) and a lower portion (104/106), wherein the upper portion comprises more material on a lateral side of the nail than a medial side of the nail (see paragraphs [0060] and [0061]). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the lateral side of the upper portion of the intramedullary nail of Ekholm to include more material as suggested by James in order to increase the strength and robustness of the proximal portion of the nail, thus increasing rotational stability of the nail, and enhancing resistance to bending and twisting (see James, paragraph [0059]-[0061]). Such a modification would shift the central longitudinal axis of the upper portion laterally relative to the central longitudinal axis of the lower portion such that the central longitudinal axis of the upper portion is laterally offset and parallel to the central longitudinal axis of the lower portion (see marked-up Figs. 1 of Ekholm above).
Ekholm fails to disclose wherein the cylindrical upper portion is a hollow mesh cage that has a coarser mesh than a diameter of the plurality of fasteners configured to be received by the upper portion. However, Brenzel discloses a bone stabilization implant (2900) that comprises an upper portion (2904) and a lower portion (2910), wherein the upper portion is a hollow mesh cage (see paragraph [0155] and Fig. 29), wherein the hollow mesh cage has a coarser mesh than a diameter of a plurality of fasteners (2907/2908) configured to be received by the upper portion (see Fig. 29 and paragraph [0306]; see also fastener 1922 inserted through mesh 1912 in Figs. 19 and 20 and paragraphs [0161] and [0362]; anchors can pass through cells in the mesh). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the invention to have the upper portion of Ekholm be a hollow mesh cage coarser than the diameter of fasteners received by the mesh as suggested by Brenzel in order to have the upper portion mimic bone and act as a bone growth or graft scaffold (see paragraph [0155]), thus facilitating fixation of the implant to the adjacent bone, while still allowing for the fixation of the mesh to adjacent bones via fasteners (see paragraphs [0096], [0140]-[0163], and [0362]).
Regarding claim 19, Ekholm discloses wherein the length of the lower portion is greater than a width or diameter of the lower portion (see marked-up Fig. 1 above).
Regarding claim 22, Ekholm discloses wherein the upper portion is configured to be rotated within the humoral head to align the humoral head with the intramedullary canal (see paragraphs [0005], [0007], and [0022]; upper portion capable of being positioned and fixed within the humoral head via bone screws, and thus, can be rotated within the humeral head to align the humoral head with the intramedullary canal).
Claims 7, 8, 17, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Ekholm in view of James and Brenzel, and further in view of U.S. Patent Application Publication No. 2013/0096630 (Lee).
Regarding claims 7, 8, 17, and 18, Ekholm fails to disclose wherein the system further includes a plate having a plurality of holes, the plate configured to be positioned on a lateral surface of the bone (claims 7 and 17); wherein the plurality of holes of the plate are aligned with the plurality of holes of the upper and lower portion of the implant (claim 8); wherein the plurality of holes of the plate are aligned with the respective plurality of holes of the upper and lower portion of the implant (claim 18). However, Lee discloses a bone stabilization system (10, see Abstract) wherein the system comprises an intramedullary implant (14) having a plurality of holes (141) and a plate (12) having a plurality of holes (121), wherein the intramedullary implant is configured to be placed in an intramedullary canal (6) and head (3) of a bone (1) (see Figs. 2 and 3), and the plate is configured to be positioned on a lateral surface of the bone (see Figs. 2 and 3), wherein the plurality of holes of the plate are aligned with respective plurality of holes of the intramedullary implant (see Figs. 2 and 3). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the system of Ekholm to include a plate as suggested by Lee in order to provide enhanced structural strength and lower the risk of a failed surgery by providing the system with both an intramedullary implant and lateral bone plate to support a fractured bone (see Lee, Abstract).
Claims 10, 11, 15, 16, 20, and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Ekholm in view of James and Brenzel, and further in view of U.S. Patent No. 6,712,858 (Grundei).
Regarding claims 10, 11, and 16, Ekholm fails to disclose wherein the upper portion includes an opening to receive a portion of the lower portion (claim 10); wherein the lower portion is received in the opening in the upper portion and is threaded into the upper portion to secure the upper and lower portions together (claim 11); and wherein an upper end of the lower portion is threadably received in a lower end of the upper portion (claim 16). However, Ekholm discloses a system (see Fig. 1) that includes an intramedullary implant (4/6) that includes an upper portion (4) and a lower portion (6), wherein the lower portion includes an upper end opening (7) to receive a lower end (5) of the upper portion, and wherein the lower end of the upper portion is received in the upper end opening in the lower portion and is threaded into the lower portion to secure the upper and lower portions together (see col. 3, lines 39-44 and Fig. 1). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the implant of Ekholm to be a two-piece implant with the upper and lower portions threadably connected as suggested by Grundei in order to allow the length of the implant to be adjustable, and thus, tailored to the length optimal for a given patient (see Grundei, Abstract, col. 1, lines 55-67, and col. 2, lines 35-38). Additionally, it would have been prima facie obvious to have the lower end of the upper portion have the opening and the upper end of the lower portion have the portion received in the opening, or vice versa, as it has been held that a mere reversal of the working parts of a device involves only routine skill in the art when it does not affect the critical functioning of the device. See In re Gazda, 219 F.2d 449, 104 USPQ 400 (CCPA 1955) (Prior art disclosed a clock fixed to the stationary steering wheel column of an automobile while the gear for winding the clock moves with steering wheel; mere reversal of such movement, so the clock moves with wheel, was held to be an obvious modification.
Further regarding claim 16, Ekholm fails to disclose wherein the cylindrical upper portion is a hollow mesh cage. However, Brenzel discloses a bone stabilization implant (2900) that comprises an upper portion (2904) and a lower portion (2910), wherein the upper portion is a hollow mesh cage (see paragraph [0155] and Fig. 29). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the invention to have the cylindrical upper portion of Ekholm be a hollow mesh cage as suggested by Brenzel in order to have the upper portion mimic bone and act as a bone growth or graft scaffold (see paragraph [0155]), thus facilitating fixation of the implant to the adjacent bone.
Regarding claims 15, 20, and 21, Ekholm fails to disclose wherein the upper portion includes an opening to receive a portion of the lower portion (claim 20); wherein the lower portion is received in the opening in the upper portion and is threaded into the upper portion to secure the upper and lower portions together (claim 21); and wherein an upper end of the lower portion is threadably received in a lower end of the upper portion (claim 15). However, Grundei discloses a system (see Fig. 1) that includes an intramedullary implant (4/6) that includes an upper portion (4) and a lower portion (6), wherein the lower portion includes an upper end opening (7) to receive a lower end (5) of the upper portion, and wherein the lower end of the upper portion is received in the upper end opening in the lower portion and is threaded into the lower portion to secure the upper and lower portions together (see col. 3, lines 39-44 and Fig. 1). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the implant of Ekholm to be a two-piece implant with the upper and lower portions threadably connected as suggested by Grundei in order to allow the length of the implant to be adjustable, and thus, tailored to the length optimal for a given patient (see Grundei, Abstract, col. 1, lines 55-67, and col. 2, lines 35-38). Additionally, it would have been prima facie obvious to have the lower end of the upper portion have the opening and the upper end of the lower portion have the portion received in the opening, or vice versa, as it has been held that a mere reversal of the working parts of a device involves only routine skill in the art when it does not affect the critical functioning of the device. See In re Gazda, 219 F.2d 449, 104 USPQ 400 (CCPA 1955) (Prior art disclosed a clock fixed to the stationary steering wheel column of an automobile while the gear for winding the clock moves with steering wheel; mere reversal of such movement, so the clock moves with wheel, was held to be an obvious modification.
Response to Arguments
Applicant's arguments filed June 17, 2026 have been fully considered but they are not persuasive.
Applicant argues on pages 5-6 of the Remarks that Brenzel does not disclose a mesh cage that is coarser than a diameter of the plurality of fasteners configured to be received by the upper portion, citing to paragraph [0222] and Fig. 1 of Brenzel. The examiner disagrees. Paragraph [0222] of Brenzel states that an anchoring substrate 122 is present inside cage 105, and may have an expanded state used for deployment and fracture repair and a collapsed state used for delivery. Paragraph [0222] does not comment on the coarseness of the anchoring substrate 122, or any anchoring substrate. Further, Figure 1 appears to show anchors 116 and 114 extending through cells of the mesh that that define anchoring substrate 122. Further, as noted above, Brenzel explicitly states and shows that the anchoring substrates can allow passing through of anchors in cells of the mesh (see Fig. 29 and paragraph [0306]; see also fastener 1922 inserted through mesh 1912 in Figs. 19 and 20 and paragraphs [0161] and [0362]; anchors can pass through cells in the mesh).
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NICHOLAS J PLIONIS whose telephone number is (571)270-3027. The examiner can normally be reached on Monday - Friday, 9:00 a.m. - 5:00 p.m. EST.
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/NICHOLAS J PLIONIS/Primary Examiner, Art Unit 3773
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