DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
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 1-3, 5, and 17 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Application Publication No. 2009/0163955 (Moumene) in view of U.S. Patent Application Publication No. 2011/0307014 (Ninomi).
Regarding claim 1, Moumene discloses a fixture rod comprising: a core member (41/43) containing a fiber-reinforced resin (see paragraph [0050]); and a coating resin (7) layer coating the core member (see paragraph [0059] and Figs. 6a-6c).
Further regarding claim 1, Moumene is silent regarding the coating resin layer having an elongation of 30% or more. However, Moumene discloses that the coated rod has enhanced fatigue endurance (see paragraphs [0014]), and tensile, flexural, and compressive endurance can be optimized (see paragraphs[ 0056] and [0057]). Additionally, Ninomi discloses a spinal rod having an elongation greater than 15% is preferred in order to allow for toughness of the rod to be maintained despite bending by the user, and allows for an excellent balance of physical properties (see paragraphs [0037] and [0038]). It would have been prima facie obvious to a person of ordinary skill in the art to have the coating resin layer have an elongation of 30% or more in order to allow for bending of the rod that does not cause the rod to lose toughness. Additionally, in the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Further regarding claim 1, Moumene is silent regarding the coating resin layer thickness being in a range of 0.05 mm to 0.4 mm. However, Moumene discloses the diameter of the external rod profile can be tailored by the user (see paragraph [0045]), and that the coating thickness being in a range of “microns to millimeters” (see paragraph [0058]), and “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Thus, it would have been obvious to make the coating thickness be in the recited range, as Moumene discloses the general coating thickness condition and it would be obvious to discover the optimum or workable coating thickness range recited in the claim.
Regarding claims 2 and 3, Moumene discloses wherein a fiber volume content (VF) in a vicinity of a surface layer of the core member is in a range of 50% to 70% (see paragraphs [0068] and [0069]), and, wherein a fiber volume content (VF) in a vicinity of a surface layer of the core member is in a range of 55% to 65% (see paragraphs [0068] and [0069]). Additionally, in the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Regarding claim 5, Moumene discloses wherein a resin of the core member and a resin of the coating resin layer are the same thermoplastic resin (PEEK, see paragraphs [0050] and [0058]).
Regarding claim 17, Moumene wherein a marker is embedded in the core member (see paragraph [0060]).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Moumene in view of Ninomi, and further in view of U.S. Patent Application Publication No. 2006/0247638 (Trieu).
Regarding claim 4, Moumene discloses wherein the number of core member layers maybe customized (see paragraphs [0008] and [0047]). Additionally, this claim is a product-by-process claim, and Moumene already discloses a core member made of a plurality of layers. “[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985) (citations omitted). The burden shifts to applicant to come forward with evidence establishing an nonobvious difference between the claimed product and the prior art product. See In re Marosi, 710 F.2d 799, 803, 218 USPQ 289, 292-33 (Fed. Cir. 1983).
Alternatively, Trieu discloses a way to form a plurality of layers of a composite spinal plate core is by laminating them (see paragraph [0023]), and it would be prima facie obvious to a person of ordinary skill in the art before the effective filing date of the invention to form the core member by laminating a plurality of layers, as Trieu suggests laminating a plurality of layers is suitable method for forming a composite core member of a spinal fixation element.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Moumene in view of Ninomi, and further in view of U.S. Patent Application Publication No. 2012/0330361 (Gepstein).
Regarding claim 6, is claim is a product-by-process claim, and Moumene already discloses a resin coating layer (see claim 1 above). “[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985) (citations omitted). The burden shifts to applicant to come forward with evidence establishing an nonobvious difference between the claimed product and the prior art product. See In re Marosi, 710 F.2d 799, 803, 218 USPQ 289, 292-33 (Fed. Cir. 1983).
Alternatively, Gepstein discloses a spinal implantable device in which a coating layer is formed by welding a tube (670) (see paragraph [0056]). 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 coating resin layer of Moumene formed by welding a tube as suggested by Gepstein as such a modification merely involves substituting one known mechanism for forming a coating layer on a spinal implantable device for another known mechanism for forming a coating layer on a spinal implantable device without any unpredictable results.
Claims 7-13 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Moumene in view of Ninomi and Trieu, and further in view of U.S. Patent Application Publication No. 2009/0093819 (Joshi).
Regarding claims 7 and 9, Moumene is silent regarding wherein in the plurality of layers of the core member, a plurality of reinforcing fiber layers and a plurality of layers of any one of a resin layer (wherein a resin of the resin layer is epoxy, phenol, unsaturated polyester, PA, PC, PPSU, POM, PP, PE, ABS, PS, PAEK, or PEEK), a reinforcing fiber layer having fibers different from those of the reinforcing fiber layer, and a reinforcing fiber layer having fibers obliquely oriented with respect to a fiber direction of the reinforcing fiber layer are alternately formed as viewed in a cross-section. However, Moumene discloses the number of carbon fiber layers and construction and planes of fiber orientation can be adjusted to further customize rod stiffness in varying planes (see paragraph [0008]). Additionally, Joshi discloses that a spinal rod composite (400) may include alternating layers of reinforcing fiber layers (401/402 and 401’/402’), with one layer (401’/402’) having fibers (402’) obliquely oriented with respect to a fiber direction of fibers (402) in the reinforcing fiber layer as viewed in a cross-section (see Fig. 15 and paragraph [0061]).
Regarding claim 8, Moumene discloses wherein the reinforcing fiber layer is a fiber-reinforced resin (see paragraph [0050]), uses carbon, glass, boron, SiC, or aramid as fibers (carbon, see paragraph [0050]), and uses epoxy, phenol, unsaturated polyester, PA, PC, PPSU, POM, PP, PE, ABS, PS, PAEK, or PEEK as a resin (PEEK, see paragraph [0050]). Joshi also suggests using glass or carbon fibers, and a PEEK resin (see paragraph [0048]).
Regarding claim 10, Moumene as modified by Joshi in claim 7 above suggests wherein the reinforcing fiber layer having fibers different from those of the reinforcing fiber layer is a fiber-reinforced resin (see paragraph [0050]), uses carbon, glass, boron, SiC, or aramid as fibers (carbon, see paragraph [0050]), and uses epoxy, phenol, unsaturated polyester, PA, PC, PPSU, POM, PP, PE, ABS, PS, PAEK, or PEEK as a resin (PEEK, see paragraph [0050]). Joshi also suggests using glass or carbon fibers, and a PEEK resin (see paragraph [0048]).
Regarding claim 11, Joshi discloses wherein in the reinforcing fiber layer or the reinforcing fiber layer having fibers different from those of the reinforcing fiber layer, fibers are aligned in one direction, formed in a woven fabric form, or randomly oriented (in both layers, fibers are aligned in one direction, see paragraph [0061] and Fig. 15).
Regarding claim 12, Joshi discloses wherein a fiber direction of the reinforcing fiber layer having fibers obliquely oriented with respect to the fiber direction of the reinforcing fiber layer is obliquely oriented within a range of 10° to 90° (see paragraphs [0061] and [0068]). Additionally, in the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Regarding claim 13, Joshi discloses wherein when a plurality of layers of any one of a resin layer, a reinforcing fiber layer having fibers different from those of the reinforcing fiber layer, and a reinforcing fiber layer having fibers obliquely oriented with respect to the fiber direction of the reinforcing fiber layer are provided, the layers are the same layers or different layers (see paragraphs [0049], [0061], [0065], and [0071]).
Regarding claim 15, Moumene discloses wherein a fiber content of the reinforcing fiber layer is 50% by volume or more (see paragraphs [0068] and [0069]).
Further regarding claims 7-13 and 15, 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 rod of Moumene to have alternating reinforced fiber layers with fibers oriented in different direction as suggested by Joshi in order to provide load carrying strength to the rod in multiple directions (see Joshi, paragraph [0061]), thus approximating a range of motion of a healthy spine (see Joshi, Abstract).
Claims 14 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Moumene in view of Ninomi, Trieu, and Joshi and further in view of U.S. Patent Application Publication No. 2006/0189982 (Lange).
Regarding claim 14, Moumene discloses the fibers can have consistent or variable lengths, which can be continuous strands (see paragraphs [0053] and [0068]). Alternatively, Lange discloses a composite spinal rod (30) comprises long carbon fibers (see paragraph [0022]), and it would have been prima facie obvious to have the fibers of Moumene be long fibers as Moumene suggests fibers of various length may be used (see Moumene, paragraphs [0053] and [0068], and Lange suggests such fibers are suitable for use in a composite spinal rod (see Lange, paragraph [0020]).
Regarding claim 16, Joshi suggests wherein fiber directions of the reinforcing fiber layer are aligned (see paragraph [0061]). Moumene is silent regarding a thickness of the reinforcing fiber layer. However, Lange discloses a composite spinal rod (30) wherein a thickness of a reinforcing fiber layer is in a range of 0.02 mm to 0.3 mm (see paragraph [0029]), and 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 thickness of the reinforcing fiber layer to be within the recited claimed range as Lange suggests such a layer thickness is suitable for providing a composite spinal rod to resist biomechanical forces as necessary (see Lange, paragraph [0029]). Additionally, in the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Conclusion
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/NICHOLAS J PLIONIS/Primary Examiner, Art Unit 3773
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