DETAILED ACTION
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on February 25, 2026 has been entered.
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 13, 19, and 22 are rejected under 35 U.S.C. 103 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).
Regarding claim 13, 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 below).
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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).
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, and 14 are rejected under 35 U.S.C. 1023 as being unpatentable over Ekholm in view of 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 above).
Ekholm fails to disclose wherein the 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 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 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 claim 14, 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.
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, and 16 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.
Claims 15, 20, and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Ekholm in view of James and Grundei.
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 with respect to claims 6-22 have been considered but are moot in view of the new grounds of rejection.
Additionally, Applicant argues on pages 6-8 of the Remarks that that upper portion of the implant of Boileau is not adapted to be received in the head of the humerus. While the examiner believes the upper portion of the implant of Boileau can be configured to be received in the head of the humerus, that examiner now relies on Ekholm, which more clearly discloses an implant having an upper portion adapted to be received in the head of the humerus (see Ekholm, paragraphs [0005], [0007], and [0022]).
Conclusion
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, 10:00 a.m. - 6:00 p.m. EST.
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/NICHOLAS J PLIONIS/Primary Examiner, Art Unit 3773