DETAILED ACTION
Claim Objections
Claims 1, 29, and 30 are objected to because of the following informalities:
Regarding claim 1, “said expandable device” should be “said expandable frame”.
Regarding claims 29 and 30, “inserting a second expandable device” should be “inserting the second expandable device”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 2, 4, 6, 10, 17, 18, 20, 22, 24, and 26 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 2, from which claims 4, 6, and 10 depend, claim 17, and claim 18, from which claims 20, 22, 24, and 26 depend, “said other metals” lacks antecedent basis, and it is unclear what is meant by “additive metal”, whether it is meant to refer to the additive material or any additive metal. For the purpose of examination, it is assumed the combination can include any metal other than rhenium and the additive material.
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, 2, 9-11, 13, 17, 23, 25, and 27 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent No. 6,783,530 (Levy) in view of U.S. Patent Application Publication No. 2020/0149137 (Roth).
Regarding claim 1, Levy discloses an expandable frame (218, see Figs. 7, 9, and 11 and col. 11, lines 37-49) used for fixation, repair and/or stabilization of bone having an intramedullary canal; said expandable frame is configured to be inserted into the intramedullary canal of a bone (see Figs. 9 and 11); said expandable frame has an unexpanded state that enables said expandable frame to be inserted into said intramedullary canal (see Figs. 8 and 9); said expandable frame has an expanded state that enables said expandable frame to be secured (see Fig. 11; see also col. 14, lines 19-27 and col. 14, line 40 – col. 15, line 10); said expandable frame is expandable from a first cross-sectional size in said unexpanded state (see Fig. 9) to a second cross-sectional size in said expanded state (see Fig. 11); a cross-sectional area of said expandable frame in said second cross-sectional size is larger than a cross-sectional area of said expandable frame in said first cross-sectional size (see marked-up Figs. 9 and 11 below); said expandable frame has a side wall that includes one or more openings in a frame wall of said expandable frame (see Figs. 7 and 11; see also col. 11, lines 39-49; interconnecting structure 218 is porous and takes the form of mesh 220); said expandable frame is at least partially formed of metal alloy (see col. 12, lines 42-45).
PNG
media_image1.png
692
787
media_image1.png
Greyscale
Levy fails to disclose at least 50 wt.% of said expandable frame is at least partially formed of metal alloy that includes at least 5 awt.% rhenium and additive material; said additive material includes one or more metals that are selected from the group consisting of aluminum, boron, beryllium, bismuth, cadmium, calcium, cerium, chromium, cobalt, copper, gallium, gold, hafnium, iridium, iron, lanthanum, lithium, magnesium, manganese, nickel, niobium, osmium, palladium, platinum, rare earth metals, rhodium, ruthenium, scandium, silver, silicon, tantalum, technetium, tin, titanium, tungsten, vanadium, yttrium, zinc, zirconium; said rhenium and said additive material constitutes at least 90 wt.% of said rhenium metal alloy. However, Roth discloses expandable medical devices (see paragraphs [0004] and [0005], e.g.) can be improved by having at least 50 wt. % of the device be formed of a tungsten/rhenium metal alloy (see paragraph [0011]), the tungsten/rhenium alloy includes at least 5 awt. % rhenium and tungsten additive material (see paragraph [0006]); said rhenium and said additive material constitutes at least 90 wt. % of said metal alloy (see Abstract and paragraphs [0006] and [0011]). 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 expandable frame of Levy to include a tungsten/rhenium alloy as suggested by Roth in order to provide the frame with an improvement in one or more properties (e.g., strength, durability, hardness, biostability, bendability, coefficient of friction, radial strength, flexibility, tensile strength, tensile elongation, longitudinal lengthening, stress-strain properties, improved recoil properties, radiopacity, heat sensitivity, biocompatibility, improved fatigue life, crack resistance, crack propagation resistance, etc.) without having to increase the bulk, volume and/or weight of the medical device (see Roth, paragraphs [0003]-[0005]).
Regarding claim 2, Roth discloses wherein said rhenium alloy includes 0-2 wt.% of a combination of metals other than rhenium and additive metal, carbon, oxygen, phosphorous, sulfur, hydrogen and nitrogen; said other metals are metals other than said rhenium and said additive material (see paragraphs [0006], [0008], and [0009]).
Regarding claims 9 and 10, Levy discloses wherein said expandable frame has a generally hollow tubular shape (see Figs. 7-9 and 11-14).
Regarding claim 11, Levy discloses a method for repairing a bone (see col. 13, lines 28-37) comprising: providing a damaged bone (fractured femur 100, Fig. 9) that includes a fracture (128) or void; providing an expandable device (device 200, see Fig. 9 and 11); said expandable device includes an expandable frame (porous interconnecting structure 218, see Fig. 7; see also col. 11, lines 37-49); said expandable frame has an unexpanded state that enables said expandable frame to be inserted into said bone or between bone fragments (see Figs. 8-9); said expandable frame has an expanded state that enables said expandable frame to be secured in the bone while traversing a fracture site of the fractured bone (see Fig. 1; see also col. 14, lines 19-27 and col. 14, line 40 – col. 15, line 10) and/or filling voids in the bone; said expandable frame has a longitudinal length that is sufficient to fully span said fracture site or voids (see Figs. 9 and 11); said expandable frame is expandable from a first cross-sectional size in said unexpanded state (Fig. 9) to a second cross-sectional size in said expanded state (Fig. 11); a cross-sectional area of said expandable frame in said second cross-sectional size is larger than a cross-sectional area of said expandable frame in said first cross-sectional size (see marked-up Figs. 9 and 11 ); said expandable frame has a side wall that includes one or more openings (see Figs. 7 and 11; see also col. 11, lines 39-49; interconnecting structure 218 is porous and takes the form of mesh 220); said expandable frame is at least partially formed of a metal alloy (col. 12, lines 42-45); inserting said expandable device in fractures bone segments and/or voids in said bone while said expandable device is in said unexpanded state (see Fig. 9); and expanding said expandable device to said expanded state to cause said longitudinal length of said first expandable device to shorten (see marked-up Figs. 9 and 11 above and col. 14, line 65 – col. 15, line 10); and wherein expansion of said expandable device causes fixation, repair and/or stabilization of said bone (see Figs. 9 and 11; see also col. 13, lines 28-29; col. 12, lines 24-33; col. 14, line 65 – col. 15, line 10).
Levy fails to disclose the metal alloy includes at least 5 awt.% rhenium and additive material; said additive material includes one or more metals that are selected from the group consisting of aluminum, boron, beryllium, bismuth, cadmium, calcium, cerium, chromium, cobalt, copper, gallium, gold, hafnium, iridium, iron, lanthanum, lithium, magnesium, manganese, nickel, niobium, osmium, palladium, platinum, rare earth metals, rhodium, ruthenium, scandium, silver, silicon, tantalum, technetium, tin, titanium, tungsten, vanadium, yttrium, zinc, and zirconium; said rhenium and said additive material constitutes at least 90 wt.% of said rhenium metal alloy. However, Roth discloses expandable medical devices (see paragraphs [0004] and [0005], e.g.) can be improved by having at least 50 wt. % of the device be formed of a tungsten/rhenium metal alloy (see paragraph [0011]), the tungsten/rhenium alloy includes at least 5 awt. % rhenium and tungsten additive material (see paragraph [0006]); said rhenium and said additive material constitutes at least 90 wt. % of said metal alloy (see Abstract and paragraphs [0006] and [0011]). 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 expandable frame of Levy to include a tungsten/rhenium alloy as suggested by Roth in order to provide the frame with an improvement in one or more properties (e.g., strength, durability, hardness, biostability, bendability, coefficient of friction, radial strength, flexibility, tensile strength, tensile elongation, longitudinal lengthening, stress-strain properties, improved recoil properties, radiopacity, heat sensitivity, biocompatibility, improved fatigue life, crack resistance, crack propagation resistance, etc.) without having to increase the bulk, volume and/or weight of the medical device (see Roth, paragraphs [0003]-[0005]).
Regarding claim 13, Levy discloses wherein said expandable device includes a proximal portion (204), a distal portion (206), and a mid-portion (202); and further including the step of securing said proximal portion and/or a distal portion in an intramedullary canal of said bone by a) inserting one or more screws or posts into the fractured bone to limit movement of said proximal portion and/or a distal portion in said intramedullary canal (see col. 1, lines 54-58, col. 10, lines 53-54; col. 14, lines 33-36), and/or b) inserting adhesive and/or cement in said intramedullary canal to limit movement of said proximal portion and/or a distal portion in said intramedullary canal.
Regarding claim 17, Roth discloses wherein said rhenium alloy includes 0-2 wt.% of a combination of metals other than rhenium and additive metal, carbon, oxygen, phosphorous, sulfur, hydrogen and nitrogen; said other metals are metals other than said rhenium and said additive material (see paragraphs [0006], [0008], and [0009]).
Regarding claim 23, Levy discloses wherein said expandable frame has a generally hollow tubular shape (see Figs. 7-9 and 11-14).
Regarding claim 25, Levy discloses further including the step of using a sheath to facilitate insertion of said expandable device (insertion sleeve 260, see Figs. 8 and 9; see also col. 13, lines 49-52); said sheath includes a tubular structure that has a longitudinal cavity (see figs. 8 and 9); said longitudinal cavity has a size and shape that is configured to enable said expandable device in said unexpanded state to move through said longitudinal cavity (see Figs. 8 and 9; see also col. 13, lines 7-10); at least a portion of said sheath is optionally formed of an elastic material (this claim feature is understood by the Examiner as optional and thus not required to be disclosed or suggested by the prior art).
Regarding claim 27, Levy discloses further including the step of using a guidewire to facilitate insertion of a portion of said expandable device (solid, thin metallic guide, see col. 13, lines 42-52); said guidewire has sufficient flexibility and stiffness to enable said expandable device in said unexpanded state to move along said guidewire (see col. 13, lines 42-52; see also col. 14, lines 36-39 and col. 17, lines 32-36).
Claims 3, 4, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Levy in view of Roth, and further in view of U.S. Patent Application Publication No. 2009/0198343 (Spain).
Regarding claims 3, 4, and 19, Levy fails to disclose wherein said expandable frame is at least partially coated with a biocompatible material; said biocompatible material includes a) chromium nitride (CrN) coating, e) b) zirconium nitride (ZrN) coating, c) zirconium-nitrogen-carbon (ZrNC) coating, d) zirconium OxyCarbide (ZrOC) coating, and/or e) zirconium oxynitride (ZrNxOy) coating. However, Spain discloses at least partially coating an orthopedic implants with a biocompatible material that is chromium nitride (see Abstract and paragraph [0021]). 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 at least partially coat the expandable frame of Levy with a biocompatible coating that includes chromium nitride as suggested by Spain in order to improve corrosion resistance (see Spain, paragraph [0021]).
Claims 3-6, 19, and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Levy in view of Roth, and further in view of U.S. Patent Application Publication No. 2021/0251766 (Quintana-Ponce).
Regarding claims 3-6, 19, and 21, Levy fails to disclose wherein said expandable frame is at least partially coated with a biocompatible material, said biocompatible material includes zirconium oxynitride (ZrNxOy) coating. However, Quintana-Ponce discloses that an orthopedic implants can be coated with a biocompatible coating that includes zirconium oxynitride (see paragraphs [0003], [0006], [0019], [0170], [0171], [0190], and [0193]). 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 frame at least partially coated with a biocompatible material including zirconium oxynitride as suggested by Quintana-Ponce in order to provide a coating have favorable material properties (e.g., enhanced wear resistance, resists chipping, resists delamination, tunable stiffness, ductile, corrosion resistance, and oxidation resistance) (see paragraphs [0144] and [0145]).
Claims 12, 14, and 28 are rejected under 35 U.S.C. 103 as being unpatentable over Levy in view of Roth, and further in view of U.S. Patent Application Publication No. 2010/0023132 (Imran).
Regarding claim 12, Levy discloses wherein said expandable device includes a proximal portion (204), a distal portion (206) and a mid-portion (202); and wherein expansion of said proximal portion and said distal portion causes said proximal portion and said distal portion to be at least partially anchored in an intramedullary canal of said bone (see Fig. 11; see also col. 14, lines 11-50; proximal and distal ends of device 200 firmly engage the walls of the proximal and distal metaphyseal areas). Levy appears to disclose that said step of expanding includes expanding and anchoring both said proximal portion and said distal portion of said expandable device prior to expanding said mid-portion (see Levy, col. 4, line 60 – col. 5, line 7). Alternatively, Levy does disclose that the ends and center of the intramedullary device can be selectively expanded and a longitudinal compressive force is desired when the device is expanded (see Levy, col. 4, line 60 – col. 5, line 7), and Imran suggests that an expandable implantable device can cause a longitudinal compressive force by selectively expanding and anchoring ends of the implantable device before expansion of a middle of the implantable device (see Imran, paragraphs [0004] and [0046]). 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 method of Levy to expand and anchor the proximal and distal portions prior to expanding said mid-portion in order to create a longitudinally compressive force that helps bring the fractured bone segments together to facilitate healing of the bone.
Regarding claim 14, Levy discloses wherein said expandable device includes a proximal portion (204), a distal portion (206), and a mid-portion (202); and further including the step of securing both said proximal portion and said distal portion in said intramedullary canal (prior to expanding said mid-portion, see analysis of claim 12 above) by a) inserting one or more screws or posts into fractured bone to limit movement of said proximal portion and/or a distal portion in said intramedullary canal (see col. 1, lines 54-58, col. 10, lines 53-54; col. 14, lines 33-36), and/or b) inserting adhesive and/or cement in said intramedullary canal to limit movement of said proximal portion and/or a distal portion in said intramedullary canal.
Regarding claim 28, Levy discloses further including the step of using a guidewire to facilitate insertion of a portion of said expandable device (solid, thin metallic guide, see col. 13, lines 42-52); said guidewire has sufficient flexibility and stiffness to enable said expandable device in said unexpanded state to move along said guidewire (see col. 13, lines 42-52; see also col. 14, lines 36-39 and col. 17, lines 32-36).
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Levy in view of Roth, and further in view of U.S. Patent No. 8,187,336 (Jamali).
Regarding claim 15, Levy discloses further including the steps of a) removing at least a portion of bone marrow from an intramedullary canal of said bone prior to insertion of said expandable device in said intramedullary canal (see col. 13, lines 38-49; inner cortex can be reamed prior to insertion of the device). Levi fails to disclose b) at least partially inserting at least a portion of said removed bone marrow into said intramedullary canal after said step of expanding said expandable device in said intramedullary canal. However, Jamali discloses a method of implanting a medical device for treatment of osseous skeletal defects (see col. 1, lines 37-39), the method including at least partially inserting at least a portion of said removed bone marrow into an intramedullary canal after a step of placing an implantable device in said intramedullary canal (see col. 11, lines 62-66 and col. 12, lines 52-66; autologous bone marrow is used to fill enclosed intracavitary space). 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 method of Levy to insert removed bone marrow into the intramedullary canal after expansion of the device as suggested by Jamali in order to facilitate reconstituted bone growth (see Jamali, col. 7, lines 8-17 and 34-41; col. 11, line 66 – col. 12, line 5).
Claims 16 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Levy in view of Roth and Imran, and further in view of Jamali.
Regarding claim 16, Levy discloses further including the steps of a) removing at least a portion of bone marrow from said intramedullary canal prior to insertion of said expandable device in said intramedullary canal (see col. 13, lines 38-49; inner cortex can be reamed prior to insertion of the device). Levi fails to disclose b) at least partially inserting at least a portion of said removed bone marrow into said intramedullary canal after said step of expanding said expandable device in said intramedullary canal. However, Jamali discloses a method of implanting a medical device for treatment of osseous skeletal defects (see col. 1, lines 37-39), the method including at least partially inserting at least a portion of said removed bone marrow into an intramedullary canal after a step of placing an implantable device in said intramedullary canal (see col. 11, lines 62-66 and col. 12, lines 52-66; autologous bone marrow is used to fill enclosed intracavitary space). 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 method of Levy to insert removed bone marrow into the intramedullary canal after expansion of the device as suggested by Jamali in order to facilitate reconstituted bone growth (see Jamali, col. 7, lines 8-17 and 34-41; col. 11, line 66 – col. 12, line 5).
Regarding claim 18, Roth discloses wherein said rhenium alloy includes 0-2 wt.% of a combination of metals other than rhenium and additive metal, carbon, oxygen, phosphorous, sulfur, hydrogen and nitrogen; said other metals are metals other than said rhenium and said additive material (see paragraphs [0006], [0008], and [0009]).
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Levy in view of Roth, Imran, and Jamali, and further in view of Spain.
Regarding claim 20, Levy fails to disclose wherein said expandable frame is at least partially coated with a biocompatible material; said biocompatible material includes a) chromium nitride (CrN) coating, e) b) zirconium nitride (ZrN) coating, c) zirconium-nitrogen-carbon (ZrNC) coating, d) zirconium OxyCarbide (ZrOC) coating, and/or e) zirconium oxynitride (ZrNxOy) coating. However, Spain discloses at least partially coating an orthopedic implants with a biocompatible material that is chromium nitride (see Abstract and paragraph [0021]). 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 at least partially coat the expandable frame of Levy with a biocompatible coating that includes chromium nitride as suggested by Spain in order to improve corrosion resistance (see Spain, paragraph [0021]).
Claims 20, 22, 24, and 26 are rejected under 35 U.S.C. 103 as being unpatentable over Levy in view of Roth, Imran, and Jamali, and further in view of Quintana-Ponce.
Regarding claims 20 and 22, Levy fails to disclose wherein said expandable frame is at least partially coated with a biocompatible material, said biocompatible material includes zirconium oxynitride (ZrNxOy) coating. However, Quintana-Ponce discloses that an orthopedic implants can be coated with a biocompatible coating that includes zirconium oxynitride (see paragraphs [0003], [0006], [0019], [0170], [0171], [0190], and [0193]). 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 frame at least partially coated with a biocompatible material including zirconium oxynitride as suggested by Quintana-Ponce in order to provide a coating have favorable material properties (e.g., enhanced wear resistance, resists chipping, resists delamination, tunable stiffness, ductile, corrosion resistance, and oxidation resistance) (see paragraphs [0144] and [0145]).
Regarding claim 24, Levy discloses wherein said expandable frame has a generally hollow tubular shape (see Figs. 7-9 and 11-14).
Regarding claim 26, Levy discloses further including the step of using a sheath to facilitate insertion of said expandable device (insertion sleeve 260, see Figs. 8 and 9; see also col. 13, lines 49-52); said sheath includes a tubular structure that has a longitudinal cavity (see figs. 8 and 9); said longitudinal cavity has a size and shape that is configured to enable said expandable device in said unexpanded state to move through said longitudinal cavity (see Figs. 8 and 9; see also col. 13, lines 7-10); at least a portion of said sheath is optionally formed of an elastic material (this claim feature is understood by the Examiner as optional and thus not required to be disclosed or suggested by the prior art).
Claims 29, 33, and 35 are rejected under 35 U.S.C. 103 as being unpatentable over Levy in view of Roth, and further in view of U.S. Patent Application Publication No. 2013/0253661 (D’Agostino).
Regarding claim 29, Levy teaches, in a different embodiment, providing a second expandable device (see Figs. 67-69, an additional device 300 is provided); said second expandable device includes a second expandable frame (interconnection structure 218, see Fig. 23; see also col. 16, lines 47-56) with at least one opening (openings in mesh 220, see Fig. 23; see also col. 16, lines 47-56); said second expandable frame, when oriented in an unexpanded state, enables said second expandable device to be inserted into at least a portion of said expandable device when in said expanded state (see Fig. 68; device 300 capable of such insertion); said second expandable frame is configured to be expanded to an expanded state (see Fig. 69); said second expandable frame is expandable from a first cross-sectional size in said unexpanded state (see Fig. 68) to a second cross-sectional size (see Fig. 69); a cross-sectional area of said second expandable frame in said second cross-sectional size is larger than a cross-sectional area of said second expandable frame in said first cross-sectional size (see Figs. 68 and 69); said second expandable frame has a side wall that includes a plurality of openings (see Figs. 25 and 26; walls of the device are formed of mesh 220); inserting a second expandable device in an interior of said expanded expandable device (see Fig. 68); and expanding said second expandable device in an interior of said expanded expandable device to increase a strength and/or rigidity about a region of said bone (see Fig. 69; see also col. 34, lines 6-9). It would have been prima facie obvious to modify the method to include a second expandable device in order to provide further stability to the fractured bone (see Fig. 69; see also col. 34, lines 6-9).
Levy fails to disclose the second expandable frame is at least partially formed of a metal alloy includes at least 5 awt.% rhenium and additive material; said additive material includes one or more metals that are selected from the group consisting of aluminum, boron, beryllium, bismuth, cadmium, calcium, cerium, chromium, cobalt, copper, gallium, gold, hafnium, iridium, iron, lanthanum, lithium, magnesium, manganese, molybdenum, nickel, niobium, osmium, palladium, platinum, rare earth metals, rhodium, ruthenium, scandium, silver, silicon, tantalum, technetium, tin, titanium, tungsten, vanadium, yttrium, zinc, zirconium; said rhenium and said additive material constitutes at least 90 wt.% of said rhenium metal alloy. However, Roth discloses expandable medical devices (see paragraphs [0004] and [0005], e.g.) can be improved by having at least 50 wt. % of the device be formed of a tungsten/rhenium metal alloy (see paragraph [0011]), the tungsten/rhenium alloy includes at least 5 awt. % rhenium and tungsten additive material (see paragraph [0006]); said rhenium and said additive material constitutes at least 90 wt. % of said metal alloy (see Abstract and paragraphs [0006] and [0011]). 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 expandable frame of Levy to include a tungsten/rhenium alloy as suggested by Roth in order to provide the frame with an improvement in one or more properties (e.g., strength, durability, hardness, biostability, bendability, coefficient of friction, radial strength, flexibility, tensile strength, tensile elongation, longitudinal lengthening, stress-strain properties, improved recoil properties, radiopacity, heat sensitivity, biocompatibility, improved fatigue life, crack resistance, crack propagation resistance, etc.) without having to increase the bulk, volume and/or weight of the medical device (see Roth, paragraphs [0003]-[0005]).
Levi fails to disclose inserting the second expandable device along a longitudinal length of said expanded expandable device so as to increase a strength and/or rigidity about a damaged region of said bone. However, D’Agostino discloses a method of repairing a long bone that includes inserting a second expandable device (one of reinforcing tubes 22) along a longitudinal length of an expanded expandable device (one of reinforcing tubes 22 that receives another tube 22 nested inside it) (see paragraph [0111]). 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 method of Levi to insert a second expandable device along a longitudinal length of a first expanded expandable device in order to provide a reinforced stabilization of a fractured bone, the amount of reinforcement tailored to the needs of the patient (see D’Agostino, paragraph [0111]). Additionally, such a method involves duplicating the number of expandable devices used to stabilize the damaged bone, 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).
Regarding claim 33, Levi suggests wherein an expandable device is configured to a) foreshorten when expanded such that said longitudinal length of said expandable device is less than a longitudinal length of said second expandable device in an unexpanded state (see Figs. 9 and 11). It would have been prima facie obvious to have the second expandable device be configured to foreshorten when expanded in order to provide a compressive longitudinal force on the bones (Levi, see col. 4, line 60 – col. 5, line 7). Additionally, it would be obvious to have the expanded length be at least 10% less than the unexpanded length as it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding claim 35, D’Agostino suggests wherein ends of said second expandable device when said second expandable device is expanded inside said expandable device do not extend beyond ends of said expandable device in said expanded state (see Fig. 20 and paragraph [0111]).
Claims 30, 34, and 36 are rejected under 35 U.S.C. 103 as being unpatentable over Levy in view of Roth and Imran, and further in view of D’Agostino.
Regarding claim 30, Levy teaches, in a different embodiment, providing a second expandable device (see Figs. 67-69, an additional device 300 is provided); said second expandable device includes a second expandable frame (interconnection structure 218, see Fig. 23; see also col. 16, lines 47-56) with an open cell configuration (openings in mesh 220, see Fig. 23; see also col. 16, lines 47-56); said second expandable frame includes a plurality of interconnected struts (spine elements 208, see Figs. 23-24); said second expandable frame, when oriented in an unexpanded state, enables said second expandable device to be inserted into at least a portion of said expandable device when in said expanded state (see Fig. 68; device 300 capable of such insertion); said second expandable frame is configured to be expanded to an expanded state (see Fig. 69); said second expandable frame is expandable from a first cross-sectional size in said unexpanded state (see Fig. 68) to a second cross-sectional size (see Fig. 69); a cross-sectional area of said second expandable frame in said second cross-sectional size is larger than a cross-sectional area of said second expandable frame in said first cross-sectional size (see Figs. 68 and 69); said second expandable frame has a side wall that includes a plurality of openings (see Figs. 25 and 26; walls of the device are formed of mesh 220); inserting a second expandable device in an interior of said expanded expandable device (see Fig. 68); and expanding said second expandable device in an interior of said expanded expandable device to increase a strength and/or rigidity about a region of said bone (see Fig. 69; see also col. 34, lines 6-9). It would have been prima facie obvious to modify the method to include a second expandable device in order to provide further stability to the fractured bone (see Fig. 69; see also col. 34, lines 6-9).
Levy fails to disclose the second expandable frame is at least partially formed of a metal alloy includes at least 5 awt.% rhenium and additive material; said additive material includes one or more metals that are selected from the group consisting of aluminum, boron, beryllium, bismuth, cadmium, calcium, cerium, chromium, cobalt, copper, gallium, gold, hafnium, iridium, iron, lanthanum, lithium, magnesium, manganese, nickel, niobium, osmium, palladium, platinum, rare earth metals, rhodium, ruthenium, scandium, silver, silicon, tantalum, technetium, tin, titanium, tungsten, vanadium, yttrium, zinc, zirconium; said rhenium and said additive material constitutes at least 90 wt.% of said rhenium metal alloy. However, Roth discloses expandable medical devices (see paragraphs [0004] and [0005], e.g.) can be improved by having at least 50 wt. % of the device be formed of a tungsten/rhenium metal alloy (see paragraph [0011]), the tungsten/rhenium alloy includes at least 5 awt. % rhenium and tungsten additive material (see paragraph [0006]); said rhenium and said additive material constitutes at least 90 wt. % of said metal alloy (see Abstract and paragraphs [0006] and [0011]). 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 expandable frame of Levy to include a tungsten/rhenium alloy as suggested by Roth in order to provide the frame with an improvement in one or more properties (e.g., strength, durability, hardness, biostability, bendability, coefficient of friction, radial strength, flexibility, tensile strength, tensile elongation, longitudinal lengthening, stress-strain properties, improved recoil properties, radiopacity, heat sensitivity, biocompatibility, improved fatigue life, crack resistance, crack propagation resistance, etc.) without having to increase the bulk, volume and/or weight of the medical device (see Roth, paragraphs [0003]-[0005]).
Levi fails to disclose inserting the second expandable device along a longitudinal length of said expanded expandable device so as to increase a strength and/or rigidity about a damaged region of said bone. However, D’Agostino discloses a method of repairing a long bone that includes inserting a second expandable device (one of reinforcing tubes 22) along a longitudinal length of an expanded expandable device (one of reinforcing tubes 22 that receives another tube 22 nested inside it) (see paragraph [0111]). 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 method of Levi to insert a second expandable device along a longitudinal length of a first expanded expandable device in order to provide a reinforced stabilization of a fractured bone, the amount of reinforcement tailored to the needs of the patient (see D’Agostino, paragraph [0111]). Additionally, such a method involves duplicating the number of expandable devices used to stabilize the damaged bone, 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).
Regarding claim 34, Levi suggests wherein an expandable device is configured to a) foreshorten when expanded such that said longitudinal length of said expandable device is less than a longitudinal length of said second expandable device in an unexpanded state (see Figs. 9 and 11). It would have been prima facie obvious to have the second expandable device be configured to foreshorten when expanded in order to provide a compressive longitudinal force on the bones (Levi, see col. 4, line 60 – col. 5, line 7). Additionally, it would be obvious to have the expanded length be at least 10% less than the unexpanded length as it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding claim 36, D’Agostino suggests wherein ends of said second expandable device when said second expandable device is expanded inside said expandable device do not extend beyond ends of said expandable device in said expanded state (see Fig. 20 and paragraph [0111]).
Claim 37 is rejected under 35 U.S.C. 103 as being unpatentable over Levy in view of Roth and D’Agostino, and further in view of Spain
Regarding claim 37, Levy fails to disclose wherein said expandable frame is at least partially coated with a biocompatible material; said biocompatible material includes a) chromium nitride (CrN) coating, e) b) zirconium nitride (ZrN) coating, c) zirconium-nitrogen-carbon (ZrNC) coating, d) zirconium OxyCarbide (ZrOC) coating, and/or e) zirconium oxynitride (ZrNxOy) coating. However, Spain discloses at least partially coating an orthopedic implants with a biocompatible material that is chromium nitride (see Abstract and paragraph [0021]). 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 at least partially coat the expandable frame of Levy with a biocompatible coating that includes chromium nitride as suggested by Spain in order to improve corrosion resistance (see Spain, paragraph [0021]).
Claim 38 is rejected under 35 U.S.C. 103 as being unpatentable over Levy in view of Roth, Imran, and D’Agostino, and further in view of Spain.
Regarding claim 38, Levy fails to disclose wherein said expandable frame is at least partially coated with a biocompatible material; said biocompatible material includes a) chromium nitride (CrN) coating, e) b) zirconium nitride (ZrN) coating, c) zirconium-nitrogen-carbon (ZrNC) coating, d) zirconium OxyCarbide (ZrOC) coating, and/or e) zirconium oxynitride (ZrNxOy) coating. However, Spain discloses at least partially coating an orthopedic implants with a biocompatible material that is chromium nitride (see Abstract and paragraph [0021]). 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 at least partially coat the expandable frame of Levy with a biocompatible coating that includes chromium nitride as suggested by Spain in order to improve corrosion resistance (see Spain, paragraph [0021]).
Claims 39 and 40 are rejected under 35 U.S.C. 103 as being unpatentable over Levy in view of U.S. Patent Application Publication No. 2004/0049261 (Xu) and Quintana-Ponce.
Regarding claims 39 and 40, Levy discloses an expandable device (200, see figs. 9 and 11) for treating a fracture site in a fractured bone having an intramedullary canal; said expandable device includes an expandable frame (218, see Fig. 7 and col. 11, lines 37-49) that is configured to be inserted into the intramedullary canal of a fractured bone; said expandable frame has an open cell configuration (openings in mesh 220); said expandable frame includes a plurality of interconnected struts (spine elements 208); said expandable frame has an unexpanded state that enables said expandable frame to be inserted into the intramedullary canal (see Figs. 8 and 9); said expandable frame has an expanded s that enables said expandable frame to be secured in the intramedullary canal while traversing a fracture site of the fractured bone (see Fig. 11; see also col. 14, lines 19-27 and col. 14, line 40 – col. 15, line 10); said expandable frame has a longitudinal length that is sufficient to fully span the fracture site (see Figs. 9 and 11); said expandable frame is expandable from a first cross-sectional size in said unexpanded state (see Fig. 9) to a second cross-sectional size in said expanded state (see Fig. 11); a cross-sectional area of said expandable frame in said second cross-sectional size is larger than a cross-sectional area of said expandable frame in said first cross-sectional size (see marked-up Figs. 9 and 11 above); said longitudinal length of said expandable frame in said unexpanded state is greater than said longitudinal length of said expandable frame in said expanded state (see marked-up Figs. 9 and 11 above); said expandable frame has a side wall that includes a plurality of open cells (see Figs. 7 and 11; see also col. 11, lines 39-49; interconnecting structure 218 is porous and takes the form of mesh 220); said expandable frame has a generally hollow tubular shape (see Figs. 7-9 and 11-14); and said expandable frame is at least partially formed of metal alloy (see col. 12, lines 42-45).
Levy fails to disclose at least 50 wt.% of said expandable frame is formed of metal alloy that includes at least 15 awt.% rhenium and additive material; said additive material includes one or more metals that are selected from the group consisting of aluminum, boron, beryllium, bismuth, cadmium, calcium, cerium, chromium, cobalt, copper, gallium, gold, hafnium, iridium, iron, lanthanum, lithium, magnesium, manganese, molybdenum, nickel, niobium, osmium, palladium, platinum, rare earth metals, rhodium, ruthenium, scandium, silver, silicon, tantalum, technetium, tin, titanium, tungsten, vanadium, yttrium, zinc, and zirconium; said rhenium and said additive material constitutes at least 90 wt.% of said metal alloy. However, Xu discloses expandable endoprostheses (tubular members place in a lumen in the body, see paragraph [0002]) can be improved by having at least 50 wt. % of the endoprosthesis frame be formed of a molybdenum/rhenium metal alloy (see paragraph [0027]), the molybdenum/rhenium alloy includes at least 15 awt. % rhenium and molybdenum additive material (see paragraph [0008]); said rhenium and said additive material constitutes at least 90 wt. % of said metal alloy (see paragraphs [0008] and [0019]). 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 expandable frame of Levy to include a molybdenum/rhenium alloy as suggested by Xu in order to provide the frame with good radiopacity and good ductility, while keeping the frame strong and flexible (see Xu, paragraph [0007]).
Levy fails to disclose wherein at least a portion of an outer surface of said expandable frame includes a coating material that promotes formation of nitric oxide on an outer surface of said expandable frame after being implanted in said fractured bone, said coating material includes includes zirconium oxynitride (ZrNxOy) coating. However, Quintana-Ponce discloses that an orthopedic implants can be coated with a biocompatible coating that includes zirconium oxynitride (see paragraphs [0003], [0006], [0019], [0170], [0171], [0190], and [0193]). 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 outer surface of the frame at least partially coated with a material (zirconium oxynitride) that promotes formation of nitric oxide on an outer surface of said frame as suggested by Quintana-Ponce in order to provide a coating have favorable material properties (e.g., enhanced wear resistance, resists chipping, resists delamination, tunable stiffness, ductile, corrosion resistance, and oxidation resistance) (see paragraphs [0144] and [0145]).
Allowable Subject Matter
Claims 31 and 32 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claims 41 and 42 are allowed.
Response to Arguments
Applicant's arguments filed Mary 27, 2026 regarding claims 15 and 16 have been fully considered but they are not persuasive.
Applicant argues on page 23 of the Remarks that Jamali does not teach the limitation of removing bone marrow from the bone prior to insertion of the expandable device, and thereafter inserting the moved bone marrow back into the intramedullary canal. However, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Levy is relied on for disclose the step of removing at least a portion of bone marrow from an intramedullary canal of said bone prior to insertion of said expandable device in said intramedullary canal (see col. 13, lines 38-49; inner cortex can be reamed prior to insertion of the device), while Jamali is relied on for suggesting least partially inserting at least a portion of removed bone marrow into a cavity after a step of placing an implantable device in said cavity (see col. 11, lines 62-66 and col. 12, lines 52-66; autologous bone marrow is used to fill enclosed intracavitary space). 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 method of Levy to insert the removed bone marrow into the intramedullary canal after expansion of the device as suggested by Jamali in order to facilitate reconstituted bone growth (see Jamali, col. 7, lines 8-17 and 34-41; col. 11, line 66 – col. 12, line 5).
Applicant’s other arguments with respect to claims have been considered but are moot in view of the new grounds of rejection.
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, 10:00 a.m. - 6:00 p.m. EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Eduardo Robert, can be reached on 571-272-4719. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/NICHOLAS J PLIONIS/Primary Examiner, Art Unit 3773
Prosecution Insights