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 § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 32-51 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement.
Claim 32, from which all other claims depend, contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. There is no description that each pore has thin spindles extending inward toward the central cavity forming a lower set of sunken junctions and thin spindles extending outward from the central cavity forming an upper set of raised junctions, the upper set of raised junctions and the lower set of sunken junctions forming alternating rows. Applicant states on page 5 of the Remarks that support for this amended feature can be found throughout the application as filed, but does not point to any specific portion(s) of the specification and/or drawings that provide support. Paragraph [0703] of the specification states that the porous or network surfaces 2090 can include rows extending along one plan and alternating rows extending along another plane; but this does not describe junctions (sunken or raised) forming alternating rows. Paragraphs [0804], [0810], [0820], [0857], [0903], and [0945] are similar to paragraph [0703]. And while paragraphs [0810] and [0857] discuss that porous network surfaces can be a raised surface, there is no description of sets of raised junctions or sunken junctions formed by thin spindles, the sets forming alternating rows. Nor does there appear to be clear disclosure in the drawings of such a feature.
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.
Claim 32-37, 39-44, and 46-49 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Application Publication No. 2013/0110238 (Lindemann) in view of U.S. Patent Application Publication No. 2018/0110624 (Arnone).
Regarding claim 32, Lindemann discloses a spinal implant device (30; 130’ 230) comprising: a distal end (a first side of middle portion 32; 134; a first side of middle portion 232), a proximal end (a second side of middle portion 32; 132; a second side of middle portion 232), two opposing side walls (third and fourth sides of middle portion 32; 144 and 146; third and fourth sides of middle portion 232) extending between the distal end and the proximal end, an upper wall (34; 140; 234), and a lower wall (36; 142; 236); a central cavity (37; 147; 247); a movable lid (42; 152; 242); and a first network surface comprising a plurality of pores (see paragraphs [0032], [0041], and [0048]).
Lindemann is silent regarding each pore having thin spindles extending inward toward the central cavity forming a lower set of sunken junctions, each pore having thin spindles extending outward from the central cavity forming an upper set of raised junctions, the upper set of raised junctions and the lower set of junctions forming alternating rows. However, Arnone discloses a spinal implant device (10) having a porous network surfaces (40) comprising a plurality of pores (52 and/or 54 and/or 56), each pore having thin spindles (62) extending inward toward the central cavity forming a lower set of raised junctions (see marked-up Figs. 7 and 8 below), each pore having think spindles extending outward from the central cavity toward an upper set of raised junctions (see marked-up Figs. 7 and 8 below), the upper set of raised junctions and the lower set of sunken junctions forming alternating rows (see marked-up Figs. 7 and 8 below). 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 network surface of Lindemann to comprise pores having thin spindles and junctions as suggested by Arnone as Lindemann suggests the network surface may be porous and made of various materials (see Lindemann, paragraph [0032]), and Arnone discloses forming a porous network surface made of spindles and junctions facilitates bone growth through the implant pores (see Arnone, paragraphs [0029] and [0036]). Marked-up Fig. 8 shows the pores forming the alternating rows of junctions when the network surface is above the central cavity (as when the network surface is formed in the movable lid 42 of Lindemann, e.g.; see paragraphs [0032], [0041], and [0048]). Marked-up Fig. 7 shows the pores forming alternating rows of junctions when the network surface is in a sidewall adjacent the central cavity (as when the network surface is formed in a side wall membrane 21 of Lindemann, e.g.; see paragraphs [0036] and [0037] and Fig. 4).
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Regarding claim 33, Lindemann discloses wherein the movable lid comprises the first network surface (see paragraphs [0032], [0041], and [0048]).
Regarding claim 34, Lindemann discloses wherein the two opposite side walls comprise the first network surface (see paragraphs [0036] and [0037] and Fig. 4). Alternatively, Arnone discloses a spinal implant with two opposing side walls (16/18) that comprise the first network surface (40) (see Figs. 1, 4, and 7 and 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 opposing side walls to comprise the first network surface in order to provide additional locations on the implant that facilitate bone growth through the implant pores (see Arnone, paragraphs [0029] and [0036]).
Regarding claim 35. Lindemann fails to disclose wherein the proximal end comprises an opening. However, Arnone discloses a spinal implant (10) in which a proximal end (12) of the implant comprises an opening (28). 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 Lindemann to have the proximal end comprise an opening as suggested by Arnone in order to allow the implant to receive an insertion tool for use in inserting the implant into a patient (see Arnone, paragraph [0026]).
Regarding claim 36, Lindemann discloses wherein the movable lid is configured to pivot (see Figs. 1-3; pivoting of movable lid 42 from a closed configuration to a fully open configuration),.
Regarding claim 37, Lindemann discloses wherein the movable lid and the first network surface comprises the same material (the lids 42/152/242 comprise the first network surface, and thus, they both comprise the same material; see paragraphs [0032], [0041], and [0048]).
Regarding claim 39, Arnone discloses further comprising a second network surface comprising a different thickness, different pore size, and/or different spindle thickness (see paragraphs [0031]-[0034] and [0039]; different parts of the implant have pores of different sizes and spindles of different thicknesses), 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 have different network surfaces with different pore sizes and/or spindles of different thicknesses in order to tailor the implant to optimize bone ingrowth capability vs. strength to absorb compressive force (see Arnone, paragraphs [0031]-[0034] and [0039]).
Regarding claim 40, Lindemann discloses wherein the movable lid comprises the first network surface (see paragraphs [0032], [0041], and [0048]), and wherein the two opposing side walls comprise a second network surface (see paragraphs [0036] and [0037] and Fig. 4). Additionally, Arnone discloses a spinal implant with an upper surface (20) and two opposing side walls (16/18) that comprise separate network surfaces (40) having pores of different sizes and spindles of different thicknesses (see Figs. 1, 4, and 7 and 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 opposing side walls to comprise a second network surface in order to provide additional locations on the implant that facilitate bone growth through the implant pores (see Arnone, paragraphs [0029] and [0036]). Additionally, 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 different network surfaces with different pore sizes and/or spindles of different thicknesses in order to tailor the implant to optimize bone ingrowth capability vs. strength to absorb compressive force (see Arnone, paragraphs [0031]-[0034] and [0039]).
Regarding claim 41, Lindemann discloses wherein the movable lid comprises the first network surface (see paragraphs [0032], [0041], and [0048]), and wherein the lower wall comprises a second network surface (21) (see paragraph [0036] and Fig. 2). Additionally, Arnone suggests 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 different network surfaces with different pore sizes and/or spindles of different thicknesses in order to tailor the implant to optimize bone ingrowth capability vs. strength to absorb compressive force (see Arnone, paragraphs [0031]-[0034] and [0039]).
Regarding claim 42, Lindemann discloses further comprising a second network surface (21, see paragraph [0036] and Fig. 2), and wherein the first and second network surfaces are diametrically opposed (42 and 21 porous networks are diametrically opposed, see Figs. 1-3). Alternatively, Arnone discloses a spinal implant with two diametrically opposed side walls (16/18) that comprise separate network surfaces (40) (see Figs. 1, 4, and 7 and 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 diametrically opposing side walls of the implant of Lindemann to comprise first and second network surfaces in order to provide additional locations on the implant that facilitate bone growth through the implant pores (see Arnone, paragraphs [0029] and [0036]).
Regarding claim 43, Lindemann discloses further comprising a second network surface (21, see paragraph [0036] and Fig. 2), and wherein the first and second network surfaces are have the same total surface area (42 and 21 porous networks shown having same total surface area, see Figs. 1-3). Alternatively, Arnone discloses a spinal implant with two opposed side walls (16/18) that comprise separate network surfaces (40) having the same surface area (see Figs. 1, 4, and 7 and 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 opposing side walls of the implant of Lindemann to comprise first and second network surfaces having the same surface area in order to provide additional locations on the implant that facilitate bone growth through the implant pores (see Arnone, paragraphs [0029] and [0036]).
Regarding claim 44, Arnone suggests wherein the first network surface comprises a thickness equal to a thickness of a corresponding edge (see Figs.1, 3, 4, 9 and 10, network surfaces 40 and140 has same thickness of solid corresponding edges of sidewalls 16/18 and 116/118).
Regarding claim 46, Lindemann discloses a method comprising: providing the spinal implant device of Claim 32 (see claim 32 above; Lindemann as modified by Arnone); packing the central cavity with a material (see paragraphs [0029]-[0031]); and closing the movable lid (see paragraphs [0029]-[0031]).
Regarding claim 47, Lindemann discloses wherein the material comprises an osteoinductive material (see paragraphs [0029]-[0031]).
Regarding claim 48, Lindemann discloses wherein the material comprises a graft material (see paragraphs [0029]-[0031]).
Regarding claim 49, Lindemann discloses wherein the movable lid is configured to pivot to close (see Figs. 1-3; lid 42 is pivotable from an open configuration in Fig. 3 to a closed configuration in Fig. 1).
Claim 38 is rejected under 35 U.S.C. 103 as being unpatentable over Lindemann in view of Arnone, and further in view of U.S. Patent Application Publication No. 2016/0270931 (Trieu).
Regarding claim 38, Lindemann discloses wherein the movable lid comprises the first network surface (see paragraphs [0032], [0041], and [0048]), but fails to disclose wherein the first network surface extends between 40% and 80% of the length of the movable lid. However, Trieu discloses spinal implants wherein an upper surface of the implant is partially porous between, the porous regions of the upper surface falling within a range of between 25% and 100% of the upper surface (see paragraph [0039]). 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 first network surface only extend between part of the length of the movable lid, as Trieu suggests the percentage of an implant upper surface that is porous may be tailored by the user to obtain an optimum amount of strength vs. bone growth facilitation (see Trieu, paragraphs [0038] and [0039]). Additionally, “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.” See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Claim 45 is rejected under 35 U.S.C. 103 as being unpatentable over Lindemann in view of Arnone, and further in view of U.S. Patent Application Publication No. 2019/0133783 (Unger).
Regarding claim 45, Lindemann fails to disclose wherein the first network surface comprises a surface coating. However, Unger discloses a spinal implant (100) in which a surface coating (160) is applied to a porous structure (110) (see paragraph [0044]). 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 Lindemann to include a surface coating on the first network surface as suggested by Unger in order to further encourage bone growth (see Unger, paragraph [0044]).
Claim 50 is rejected under 35 U.S.C. 103 as being unpatentable over Lindemann in view of Arnone, and further in view of U.S. Patent Application Publication No. 2017/0105844 (Kuyler).
Regarding claim 50, Lindemann discloses a method of manufacturing a spinal device comprising: manufacturing the spinal implant device of Claim 32 (see claim 32 above; Lindemann as modified by Arnone) (see paragraph [0028]), wherein the spinal implant device is manufactured as one piece (see paragraph [0028]).
Lindemann fails to disclose 3D printing the spinal implant device. However, Kuyler discloses a method of manufacturing a spinal implant device (10) that includes using additive manufacturing, specifically 3D printing the device as one piece (see paragraph [0035]). 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 Lindemann to use 3D printing to form the device in one piece as Kuyler suggests 3D-printing is a suitable additive manufacturing technique for making a spinal implant device (see Kuyler, paragraph [0035]) and allows forming the device from materials to achieve desired implant characteristics (see Kuyler, paragraph [0035])
Claim 51 is rejected under 35 U.S.C. 103 as being unpatentable over Lindemann in view of Arnone and Kuyler, and further in view of U.S. Patent Application Publication No. 2018/0235671 (Jackson).
Regarding claim 51, Lindemann fails to disclose wherein the spinal implant device comprises a pivot pin disposed within a barrel of the movable lid. However, Jackson discloses a spinal implant in which pivoting of parts (41/42) of the implant is achieved via a pivot pin (71) disposed within a barrel (62) (see paragraphs [0077] and [0078]). 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 utilize a pivot pin disposed within a barrel of the lid in order to achieve pivoting of the lid as Jackson suggests a pivot pin in a barrel is a suitable mechanism for achieving pivoting of one part of a spinal implant relative to another part of the spinal implant (see Jackson, paragraphs [0077] and [0078]).
Response to Arguments
Applicant's arguments filed April 20, 2026 have been fully considered but they are not persuasive.
Applicant argues on page 6 of the Remarks that Arnone discloses a lattice indicated at 40 disposed heightwise between upper and lower open-cell metal foam 26, and longitudinally between end portions 12 and 14, and that the rejections have been overcome by the claim amendments. Applicant does not explain how the amendment distinguishes the claims over the teachings of the prior art. Additionally, 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). As explained in the rejection of claim 32 above, modifying the network surface of Lindemann to comprise pores having thin spindles and junctions as suggested by Arnone results in the features of amended claim 32. Marked-up Fig. 8 above shows the pores forming the alternating rows of junctions when the network surface is above the central cavity (as when the network surface is formed in the movable lid 42 of Lindemann, e.g.; see paragraphs [0032], [0041], and [0048]); marked-up Fig. 7 above shows the pores forming alternating rows of junctions when the network surface is in a sidewall adjacent the central cavity (as when the network surface is formed in a side wall membrane 21 of Lindemann, e.g.; see paragraphs [0036] and [0037] and Fig. 4).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NICHOLAS J PLIONIS whose telephone number is (571)270-3027. The examiner can normally be reached on Monday - Friday, 9:00 a.m. -5:00 p.m. EST.
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/NICHOLAS J PLIONIS/Primary Examiner, Art Unit 3773
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