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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 September 8, 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 1, 10, and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Chinese Patent No. CN 108904027 A (Li) in view of U.S. Patent Application Publication No. 2006/0084997 (Dejardin) and U.S. Patent Application Publication No. 2008/0188897 (Krebs).
Regarding claim 1, Li discloses a bone stabilization construct for positioning in a bone having a head and a shaft defining an intramedullary canal, the construct comprising: an intramedullary nail implant (1) having a central axis comprising: a distal portion (see marked-up Fig. 1 below) including a shaft extending along the central axis and configured for positioning within the intramedullary canal, wherein the distal portion defines a slot (13), and the slot includes a rack (131) with a plurality of teeth (see Figs. 2 and 5) extending into the slot; and a proximal portion (see marked-up Fig. 1 below) extending proximally from the distal portion, the proximal portion defining a contact surface (outer surface of proximal portion) which extends at least in part medially of the central axis (see Figs. 1 and 3) and which is configured to extend within the head of the bone (proximal portion of 1 can be fixed to a proximal head of a fractured bone via a screw inserted in hole 11).
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Further regarding claim 1, Li fails to disclose a screw, configured to fill a hole left from a guide used to position the intramedullary nail, the screw comprising a head having a head diameter, an external threading disposed over and circumferentially around the head, a tapered portion extending distally from the head and an unthreaded cylindrical stud extending distally from the tapered portion and having a stud diameter less than the head diameter. However, Dejardin discloses a bone stabilization construct (28/24) including an intramedullary implant (28) and channels (20) for receiving screws (24), wherein holes are drilled into bone via a guide (drill guide jig, see paragraph [0268]) used to position the intramedullary implant and facilitate placement of the screws into the channels (see paragraph [0268]), and the locking screws are configured to fill the hole left from drilling through the guide (see paragraphs [0179] and [0268]; screw 24 can have the proximal head 27 threaded into a hole in bone made via drilling through the guide), the screws comprising a head (27) having a head diameter (see Fig. 16 and paragraph [0114]), an external threading disposed over and circumferentially around the head (see Fig. 16 and paragraph [0114]), a tapered portion (26) extending distally from the head (see Fig. 16 and paragraph [0114]) and an unthreaded cylindrical stud (25) extending distally from the tapered portion and having a stud diameter less than the head diameter (see Fig. 16 and paragraph [0114]). 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 use screws configured as suggested by Dejardin in the intramedullary implant of Li as Dejardin suggests such screws facilitate locking the intramedullary implant in the intramedullary canal with low manufacturing cost and easier screw insertion (see Dejardin, paragraphs [0004], [0113], and [0114]).
Further regarding claim 1, Li is silent regarding wherein the contact surface defines a curved surface extending along the central axis. However, Krebs discloses a bone implant (30a) having a central axis (longitudinal central axis of implant 30a, see Figs. 9 and 10) and a proximal portion (68a), wherein a contact surface (184) which is configured to extend within a head of a bone (see paragraphs [0082] and [0091]; configured to extend within cortical bone, such as is present within a head of a long bone) defines a curved surface (184) extending along the central axis (see Figs. 9 and 10; convexly curved surface extends along longitudinal central axis of the implant). 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 a proximal portion of the implant of Li to include a curved contact surface as suggested by Krebs in order to help securely position the implant within a bone by forming a seal between the implant and body tissue (see Krebs, paragraph [0091]).
Regarding claim 10, Li discloses wherein the proximal portion is configured to receive a second screw (proximal locking screw for insertion into proximal locking screw hole 11).
Regarding claim 11, Lin discloses wherein the rack is configured for engagement with a pinion (132) to adjust the position of the implant in a proximal or distal direction.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Li in view of Dejardin and Krebs, and further in view of U.S. Patent Application Publication No. 2006/0095039 (Mutchler).
Regarding claim 3, Li fails to disclose wherein the proximal portion of the intramedullary nail implant has non-circular holes. However, Mutchler discloses an intramedullary nail (100) having a proximal portion (106) that has a non-circular, rectangular hole (134) for receiving a bone screw (146) (see paragraph [0097] and Figs. 1A and 1C). 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 proximal portion of Li to have a non-circular, rectangular hole in order to facilitate dynamic fixation of the long bone (see Abstract and paragraphs [0014], [0015], and [0097]). Additionally, it would have been obvious to provide more than one such hole in order to provide additional dynamic locking, and it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. See In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Li in view of Dejardin and Krebs, and further in view of U.S. Patent Application Publication No. 2007/0255283 (Ekholm).
Regarding claim 4, Li is silent as to whether the proximal portion includes a plurality of screw holes defined therethrough. However, Li does disclose that a screw hole (11) is defined through the proximal portion. Additionally, Ekholm discloses an intramedullary nail (10) having a proximal portion (16) that includes a plurality of screw holes (31/32/34/36) defined therethrough. 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 proximal portion of Li in view of Dejardin and Krebs to have a plurality of screw holes defined therethrough in order to facilitate a stronger fixation of the implant to the fractured bone and because it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. See In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Li in view of Dejardin and Krebs, and further in view of U.S. Patent No. 4,928,679 (Chagneau).
Regarding claim 5, Li is silent as to whether the proximal portion includes a thin-walled hollow structure. However, Chagneau discloses an intramedullary implant (1) wherein at least the proximal portion includes a thin-walled hollow structure (see col. 4, lines 20-23 and claim 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 at least the proximal portion of the intramedullary implant of Li in view of Dejardin and Krebs to include a thin-walled hollow structure as suggested by Chagneau in order to reduce the weight of the implant to facilitate a shorter treatment time (see Chagneau, col. 1, lines 52-55 and col. 4, lines 20-23).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Li in view of Dejardin and Krebs, and further in view of U.S. Patent Application Publication No. 2009/0182336 (Brenzel).
Regarding claim 6, Li fails to disclose wherein the proximal portion includes a mesh structure defining a plurality of openings therethrough. However, Brenzel discloses a bone stabilization implant (2900) that comprises an upper portion (2904) and a lower portion (2910), wherein the upper portion includes a coarse mesh structure defining a plurality of openings therethrough (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 Li be a mesh structure with openings 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 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Li in view of Dejardin and Krebs, and further in view of U.S. Patent No. 6,712,858 (Grundei).
Regarding claims 7 and 8, Li fails to disclose wherein the proximal portion and the distal portion are releasably interconnected to one another (claim 7); and wherein a portion of the proximal portion is longitudinally adjustable relative to the distal portion in a direction of the central axis (claim 8). However, Grundei discloses a system (see Fig. 1) that includes an intramedullary implant (4/6) that includes a proximal portion (4) and a distal portion (6), wherein the portions are releasably interconnected to one another and are longitudinally adjustable relative to each other in a direction of a central axis of the implant (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 Li to be a two-piece implant with the proximal and distal portions releasably interconnected and adjustable 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 proximal portion longitudinally adjustable to the distal portion, 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).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Li in view of Dejardin, Krebs, and Grundei, and further in view of Mutchler.
Regarding claim 9, Li fails to disclose wherein the proximal portion includes rectangular holes for receiving bone screws. However, Mutchler discloses an intramedullary nail (100) having a proximal portion (106) that has a non-circular, rectangular hole (134) for receiving a bone screw (146) (see paragraph [0097] and Figs. 1A and 1C). 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 proximal portion of Li to have a non-circular, rectangular hole in order to facilitate dynamic fixation of the long bone (see Abstract and paragraphs [0014], [0015], and [0097]). Additionally, it would have been obvious to provide more than one such hole in order to provide additional dynamic locking, and it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. See In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960).
Claims 12 and 13 are rejected under 35 U.S.C. 103 as being unpatentable Li in view of Dejardin, and further in view of U.S. Patent Application Publication No. 2007/0213725 (Hack).
Regarding claim 12, Li discloses a bone stabilization construct for positioning in a bone having a head and a shaft defining an intramedullary canal, the construct comprising: an intramedullary nail implant (1) comprising: a distal portion (see marked-up Fig. 1 below) including a shaft extending along a central axis and configured for positioning within the intramedullary canal, wherein the distal portion defines a slot (13), and the slot includes a rack (131) with a plurality of teeth (see Figs. 2 and 5) extending into the slot; and a proximal portion (see marked-up Fig. 1 below) extending proximally from the distal portion, the proximal portion defining a contact surface (outer surface of proximal portion) which extends at least in part medially of the central axis (see Figs. 1 and 3) and which is configured to extend within the head of the bone (proximal portion of 1 can be fixed to a proximal head of a fractured bone via a screw inserted in hole 11).
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Further regarding claim 12, Li fails to disclose a screw, configured to fill a hole left from a guide used to position the intramedullary nail, the screw comprising a cylindrical head having a head diameter, an external threading disposed over and circumferentially around the cylindrical head and an unthreaded stud extending distally from the cylindrical head and having a stud diameter less than the head diameter. However, Dejardin discloses a bone stabilization construct (28/24) including an intramedullary implant (28) and channels (20) for receiving screws (24), wherein holes are drilled into bone via a guide (drill guide jig, see paragraph [0268]) used to position the intramedullary implant and facilitate placement of the screws into the channels (see paragraph [0268]), and the locking screws are configured to fill the hole left from drilling through the guide (see paragraphs [0179] and [0268]; screw 24 can have the proximal head 27 threaded into a hole in bone made via drilling through the guide), the screws comprising a cylindrical head (27) having a head diameter (see Fig. 16 and paragraph [0114]), an external threading disposed over and circumferentially around the cylindrical head (see Fig. 16 and paragraph [0114]) and an unthreaded stud (25/26) extending distally from the cylindrical head and having a stud diameter less than the head diameter (see Fig. 16 and paragraph [0114]). 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 use screws configured as suggested by Dejardin in the intramedullary implant of Li as Dejardin suggests such screws facilitate locking the intramedullary implant in the intramedullary canal with low manufacturing cost and easier screw insertion (see Dejardin, paragraphs [0004], [0113], and [0114]).
Further regarding claim 12, Li is silent regarding wherein the proximal end of the proximal portion tapers to a wedge. However, Hack discloses an intramedullary bone implant (20) having a proximal portion (22), wherein the proximal end of the proximal portion tapers to a wedge (see Figs. 1 and 2 and paragraph [0022]). 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 proximal end of the proximal portion taper to a wedge as suggested by Hack in order to facilitate fixing the implant to bone via wedging the proximal end of the implant with respect to the proximal portion of the bone (see Hack, paragraph [0022]).
Regarding claim 13, Li discloses wherein the contact surface defines a curved surface (proximal portion includes a cylindrically curved contact outer surface, see Fig. 3).
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Li in view of Dejardin and Hack, and further in view of Mutchler.
Regarding claim 14, Li fails to disclose wherein the proximal portion of the intramedullary nail implant has non-circular holes. However, Mutchler discloses an intramedullary nail (100) having a proximal portion (106) that has a non-circular, rectangular hole (134) for receiving a bone screw (146) (see paragraph [0097] and Figs. 1A and 1C). 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 proximal portion of Li to have a non-circular, rectangular hole in order to facilitate dynamic fixation of the long bone (see Abstract and paragraphs [0014], [0015], and [0097]). Additionally, it would have been obvious to provide more than one such hole in order to provide additional dynamic locking, and it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. See In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960).
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Li in view of Dejardin and Hack, and further in view of Ekholm.
Regarding claim 15, Li is silent as to whether the proximal portion includes a plurality of screw holes defined therethrough. However, Li does disclose that a screw hole (11) is defined through the proximal portion. Additionally, Ekholm discloses an intramedullary nail (10) having a proximal portion (16) that includes a plurality of screw holes (31/32/34/36) defined therethrough. 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 proximal portion of Li in view of Dejardin and Hack to have a plurality of screw holes defined therethrough in order to facilitate a stronger fixation of the implant to the fractured bone and because it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. See In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960).
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Li in view of Dejardin and Hack, and further in view Chagneau.
Regarding claim 16, Li is silent as to whether the proximal portion includes a thin-walled hollow structure. However, Chagneau discloses an intramedullary implant (1) wherein at least the proximal portion includes a thin-walled hollow structure (see col. 4, lines 20-23 and claim 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 at least the proximal portion of the intramedullary implant of Li in view of Dejardin and Hack to include a thin-walled hollow structure as suggested by Chagneau in order to reduce the weight of the implant to facilitate a shorter treatment time (see Chagneau, col. 1, lines 52-55 and col. 4, lines 20-23).
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Li in view of Dejardin and Hack, and further in view of Brenzel.
Regarding claim 17, Li fails to disclose wherein the proximal portion includes a mesh structure defining a plurality of openings therethrough. However, Brenzel discloses a bone stabilization implant (2900) that comprises an upper portion (2904) and a lower portion (2910), wherein the upper portion includes a coarse mesh structure defining a plurality of openings therethrough (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 Li be a mesh structure with openings 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 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Li in view of Dejardin and Krebs, and further in view of Grundei.
Regarding claims 18 and 19, Li fails to disclose wherein a portion of the proximal portion is longitudinally adjustable relative to the distal portion in a direction of the central axis. However, Grundei discloses a system (see Fig. 1) that includes an intramedullary implant (4/6) that includes a proximal portion (4) and a distal portion (6), wherein the portions are releasably interconnected to one another and are longitudinally adjustable relative to each other in a direction of a central axis of the implant (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 Li to be a two-piece implant with the proximal and distal portions releasably interconnected and adjustable 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 proximal portion longitudinally adjustable to the distal portion, 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).
Regarding claim 20, Li discloses wherein the proximal portion is configured to receive a second screw (proximal locking screw for insertion into proximal locking screw hole 11).
Response to Arguments
Applicant’s arguments with respect to claims 1 and 3-20 have been considered but are moot in view of the new grounds of rejection.
Conclusion
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/NICHOLAS J PLIONIS/Primary Examiner, Art Unit 3773
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