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 .
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-5, 8-10, & 13-20 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 & 9 of U.S. Patent No. 12,376,969.
Although the claims at issue are not identical, they are not patentably distinct from each other because:
Claim 1 of the application recites an interbody fusion device comprising an expandable cage formed of titanium or titanium alloys (See Claim 1, Lines 1-2 of the patent), said cage comprising a top surface and an opposite bottom surface, a distal end and a proximal end including a base, a plurality of flexible arms each attached to and projecting from a hinge point at said base toward said distal end, a hollow interior, and an operable expansion member within said hollow interior (See Claim 1, Lines 2-8 of the patent), each arm being free and unattached to another of the arms at the distal end thereby allowing the cage to expand only at the distal end upon operation of the operable expansion member (See Claim 1, Lines 8-10 of the patent), each of said top surface and said bottom surface including a textured surface, each of said textured surfaces comprising: a laser ablated surface formed to have a three-dimensional geometric pattern defined by a plurality of micro-scale projections and first recesses; and an enhanced laser ablated surface on each of said laser ablated surfaces, each of said enhanced laser ablated surfaces being defined by a plurality of nano-scale structures on at least said projections (See Claim 1, Lines 10-27 of the patent).
As to Claims 2-5, 8-10 & 13 of the application: The limitations of Claims 2-4 are found in Claims 1-2 of the patent. The limitations of Claim 5 are found in Claims 1-2 & 9 of the patent. The limitations of Claims 8-10 are found in Claims 3-5 of the patent. The limitations of Claim 13 are found in Claim 1 of the patent.
Claim 14 of the application recites an interbody fusion device comprising an expandable cage formed of titanium or titanium alloys (See Claim 1, Lines 1-2 of the patent), said cage comprising a top surface and an opposite bottom surface, a distal end and a proximal end, a hollow interior, and an operable expansion member within said hollow interior (See Claim 1, Lines 2-8 of the patent), said top surface and said bottom surface being movable away from each other to thereby expand said cage upon operation of the operable expansion member (See Claim 1, Lines 8-10), each of said top surface and said bottom surface including a textured surface, each of said textured surfaces comprising: a laser ablated surface formed to have a three-dimensional geometric pattern defined by a plurality of micro-scale projections and first recesses; and an enhanced laser ablated surface on each of said laser ablated surfaces, each of said enhanced laser ablated surfaces being defined by a plurality of nano-scale structures on at least said projections (See Claim 1, Lines 10-27 of the patent).
As to Claims 15-20 of the application: The limitations of Claims 15-17 are found in Claims 1-2 of the patent. The limitations of Claim 18 are found in Claim 9 of the patent. The limitations of Claim 19-20 are found in Claims 3-5 of the patent.
Claim Objections
Claim 2 is objected to because of the following informalities: In Line 1, the word “microscale” should be replaced with the spelling --micro-scale-- in order to keep claim terminology consistent throughout. In Line 2, the word --first-- should be added before the word “recesses”. Appropriate correction is required.
Claim 3 is objected to because of the following informalities: In Lines 1-2, the limitation “on said at least said projections” should be deleted. Appropriate correction is required.
Claim 7 is objected to because of the following informalities: In Line 1, the word --said-- should be added before the word “top”. Appropriate correction is required.
Claim 9 is objected to because of the following informalities: In Line 1, the word --said-- should be added before the word “proximal”. In Line 2, the word --said-- should be added before the word “hollow”. Appropriate correction is required.
Claim 13 is objected to because of the following informalities: In Line 1, the word --operable-- should be added before the word “expansion” in order to keep claim terminology consistent throughout. Appropriate correction is required.
Claim 15 is objected to because of the following informalities: In Line 1, the word “microscale” should be replaced with the spelling --micro-scale-- in order to keep claim terminology consistent throughout. In Line 2, the word --first-- should be added before the word “recesses”. Appropriate correction is required.
Claim 16 is objected to because of the following informalities: In Lines 1-2, the limitation “on said at least said projections” should be deleted. Appropriate correction is required.
Claim 19 is objected to because of the following informalities: In Line 4, the period before the word “said” should be deleted. 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.
Claim 3-7 & 16-18 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.
Claim 3 at Lines 3-5 recites “said striped-shaped structures being spaced in a direction transverse to the respective lengths of said stripe-shaped structures by said second recesses, said stripe-shaped structures and said second recesses.” which renders the claim indefinite as it is unclear what is meant by the structures being spaced by said second recesses, said structures, and said second recesses (again). Is a patterned structural arrangement being recited, or is the latter portion of the limitation redundant? Appropriate correction is required.
Claim 6 recites “wherein said cage comprises a quadrangular shape that includes said top surface, said bottom surface and a pair of spaced opposing side surfaces that jointly define said hollow interior.” which renders the claim indefinite as a quadrangular shape is a 2D shape and the recitation is referring to a 3D structure. Thus, it appears the shape of the cage is actually cuboid or quadrangular/rectangular prism. Appropriate correction is required.
Claim 16 at Lines 3-5 recites “said striped-shaped structures being spaced in a direction transverse to the respective lengths of said stripe-shaped structures by said second recesses, said stripe-shaped structures and said second recesses.” which renders the claim indefinite as it is unclear what is meant by the structures being spaced by said second recesses, said structures, and said second recesses (again). Is a patterned structural arrangement being recited, or is the latter portion of the limitation redundant? Appropriate correction is required.
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(s) 1-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lamborne et al. (US PG Pub No. 2016/0022438) and Lin et al. (US PG Pub No. 2017/0151004) and Ullrich, JR. et al. (US PG Pub No. 2012/0312778).
Regarding Claims 1-2, 3-5 as best understood & 11, Lamborne et al. discloses an interbody fusion device (spinal implant 100, Figs. 1A-20, Paragraphs [0047-0059]) comprising an expandable titanium monolithic cage (cage body, Fig. 1A, Paragraph [0078]) having a top surface (upper bone-contacting surface of 110, Fig. 1A) and an opposite bottom surface (lower bone-contacting surface of 120, Fig. 1A), a distal end (121, Fig. 1A) and a proximal end (122, Fig. 1A) including a base (130, Fig. 1A), a plurality of flexible arms (left and right side upper arms 110 and left and right side lower arms 120, Fig. 3C) each attached to and projecting from a hinge point at said base toward said distal end (See examiner annotated Fig. 7C below), a hollow interior (channel 150, Fig. 1A, 2A, 2B, 3B), and an operable expansion member (140, Figs. 3A-5B, Paragraphs [0050-0051]) within said hollow interior, each arm being free and unattached to another of the arms at the distal end thereby allowing the cage to expand only at the distal end upon operation of the operable expansion member (Figs. 4A-4B), and each of said top surface and said bottom surface including a textured surface (serrated portions of 110 & 120, Fig. 1A, 2A, 2B, Paragraph [0078]).
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Lamborne et al. does not disclose each of said textured surfaces comprising: a laser ablated surface formed to have a three-dimensional geometric pattern defined by a plurality of micro-scale projections and first recesses; and an enhanced laser ablated surface on each of said laser ablated surfaces, each of said enhanced laser ablated surfaces being defined by a plurality of nano-scale structures on at least said projections; wherein said micro-scale projections and first recesses are formed in a laser ablation process by a pulsed laser in the nanosecond range to have a first depth of at least 100 µm; wherein said nano-scale structures comprise a plurality of stripe-shaped structures and second recesses, each of which has a length, said striped-shaped structures being spaced in a direction transverse to the respective lengths of said stripe-shaped structures by said second recesses; wherein said nano-scale structures are formed in a laser ablation process by a pulsed laser in the femtosecond range to have a second depth less than 1 pm; wherein said second depth is not greater than 200 nm. Lamborne et al. does disclose in Paragraph [0078] that “The implant material can optionally be chosen to enhance osseointegration between the implant and the living bone. For example, the components could be formed with a roughened surface texture or could be porous. PEEK, titanium or any other biocompatible material may provide adequate strength.”
Lin et al. discloses a titanium bone implant (100, Figs. 1-4 & 5B, Paragraphs [0016-0036]) comprising a textured surface (implant body 110 comprises at least one recess 110r, Fig. 4, Paragraphs [0027, 0035]) defined by least one laser ablated recess (110r) formed in the implant body (110, Paragraphs [0020, 0027, 0036], Fig. 4), wherein the diameter (D1, Fig. 4) of each recess “may depend on a diameter of the ultrafast laser light” (Paragraph [0027]) and wherein the depth (h, Fig. 4) of each recess is “may depend on energy and/or processing time of the ultrafast laser light”, wherein the textured surface comprises a laser ablated, three-dimensional pattern of micro-scale projections and first recesses formed thereon (microstructures 120 formed on inner sidewall of recess 110r in micrometer dimension in a regular pattern by ultrafast laser, Paragraphs [0020, 0036], Fig. 4), and a plurality of laser ablated nano-scale structures (microstructures 120 formed in nanometer dimension) (“the microstructures 120 may be formed in micrometer dimension, nanometer dimension or combination thereof.”, Paragraph [0020]), wherein said laser ablated nano-scale structures comprising a plurality of stripe-shaped structures and second recesses (Fig. 3, Paragraph [0025]), each of which has a length, said striped-shaped structures being spaced in a direction transverse to the respective lengths of said striped-shaped structures by said second recesses (Fig. 3, Paragraph [0025]). Lin et al. further discloses in Paragraphs [0016-0019] that “Under the processing of the ultrafast laser, a portion of a surface of the material of the implant body 110 may be removed, and the remained material forms a plurality of microstructures 120”, wherein “The microstructures 120 are formed on the surface of the implant body 110. Each microstructure 120 has a height H and a weight W, wherein the weight W is less than 2 micrometers, and the height H is less than 1 micrometer. Under such design, a surface area of the microstructure 120 may be increased, and accordingly the bone implant 100 has superhydrophilicity.”, and wherein “Due to the size design of the microstructures 120 of the present disclosure, the microstructures 120 can provide cells with a quality growing space, such that it is easy for the cells to grow and differentiate. In addition, due to the size design of the microstructures 120 of the present disclosure, the microstructures 120 vary in a small size range (such as nanometer scale) even if some microstructures 120 have large variations in size, and accordingly the large microstructures 120 do not unduly affect the growth and differentiation of the cells.” Lin et al. further discloses in Paragraph [0020] that “In an embodiment, the microstructures 120 may be formed by ultrafast laser light having infrared wavelength, and accordingly the microstructures 120 may be formed in micrometer dimension, nanometer dimension or combination thereof. Since the microstructures 120 may be formed by the ultrafast laser light, the microstructures 120 may be arranged in a regular pattern, and accordingly it is conducive to helping the cells to climb the bone implant 100 and uniformly grow. Due to the microstructures 120 are regularly arranged, the arithmetical mean deviation (Ra) of the implant body 110 of the microstructures 120 is less than 1 micrometer.” Lin et al. does not disclose that the nano-scale structures are on at least said micro-scale projections.
Ullrich et al. discloses devices and methods for producing bone implants having a roughened surface topography having a pattern designed to provide certain frictional characteristics, load dispersion, and to influence the biological responses that occur during bone healing and fusion (Abstract), wherein one particular embodiment of a titanium bone implant (spinal implant 1, Fig. 12, Paragraphs [0094-0097]) is depicted having top and bottom bone contacting surfaces (82, 82, Fig. 12) each including a textured surface (roughened topography 80, Paragraph [0095]), wherein the “The roughened surface topography 80 preferably includes micro features of a regular repeating pattern, formed during the subtractive or additive process, which may promote biological and chemical attachment or fusion with the bone structure.” (Paragraph [0102-0103, 0159]). Ullrich et al. discloses in Paragraph [0047] that “The shapes of the frictional surface protrusions or recesses provided by the subtractive process, additive process, or both processes form a roughened surface topography on at least one surface of the implant. The roughened surface topography preferably includes a predetermined repeating pattern. As used in this document, "predetermined" means determined beforehand, so that the predetermined characteristic must be determined, i.e., chosen or at least known, before use of the implant. The pattern may consist of an array of shapes or structures. The array may include a systematic arrangement of objects (e.g., dots, circles, ovals, squares, or strips) in rows, cmachining (e.g., milling, turning, or both techniques may be performed using machine tools, such as saws, lathes, milling machines, drill presses, or other equipment used with a sharp cutting tool to physically remove material to achieve a desired geometry); unmasked or masked etching (e.g., portions of the surface are protected by a masking material which resists etching and an etching substance is applied to unmasked portions); chemical, photo, electrical, electrochemical, plasma, or laser etching; cutting and removal processes; casting; forging; machining; drilling; grinding; shot peening; abrasive media blasting (such as sand or grit blasting); and combinations of these subtractive processes.” Paragraphs [0051- 0057] further discloses that the subtractive process may include “applying a temporary patterned mask before the subtractive process is performed. In other words, a mask may be applied to the desired surface, for example, to produce a desired pattern before implementing the subtractive technique. The pattern may include a designed configuration or array of dots, circles, semi-circles, squares, triangles, lines, strips, amorphous shapes, or any suitable pattern designed to provide frictional contact with opposing bones, dispersion loading, and to promote bone healing and fusion. Referring to the drawing, in which like reference numbers refer to like elements throughout the various figures that comprise the drawing, FIG. 1 depicts an embodiment of the invention where rows of maskant are applied in a first pattern 103 (e.g., dots or circles) on an original surface 104 of the implant 1.” And “The subtractive process may include a single subtractive step or multiple subtractive steps. The subtractive process may be applied sequentially, for example, to provide an array of shapes or structures recessed into the base surface.” “It is also envisioned that other angles (e.g., between 0 degree and 90 degree) may be produced in the overlapping patterns. After the pattern of maskant is applied, then an etchant may be applied, for example, to the portions of the original surface that are unprotected by the maskant.” (Figs. 2-3, 4B-4C, 6-7) Paragraph [0066] even further discloses “FIG. 10 shows an alternative example depicting an abraded surface detail which may be produced in an additive process, a subtractive process, or both processes. The three patterns may be applied simultaneously or sequentially to form a first pattern 103, a second pattern 105, and a third pattern 107 recessed into or projecting from the original surface 104. For example, the three patterns may form an overall repeating pattern on the surface of the implant 1.” Ullrich, JR. et al. further discloses in Paragraphs [0123-0124] a table depicting the macro, micro, and nano surface feature sizes and roughness, wherein the macro surface features have a depth between 40 and 500 µm with an average of 270 µm, wherein the micro surface features have a depth between 2 and 40 µm with an average of 11 µm, and wherein the nano surface features have a depth between 0.2 and 2 µm with an average of 1.1 µm.
Thus, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify each textured surface of the device of Lamborne et al. to add a laser ablated surface thereon comprising a three-dimensional geometric pattern made up of a combination of micro-scale projections and first recesses and a pattern of nano-scale stripe-shaped structures and second recesses, wherein the nano-scale striped-shaped structures are spaced in a direction transverse to the respective lengths of said striped-shaped structures by said second recesses as taught by Lin et al., wherein the plurality of nano-scale structures and recesses are formed on/overlap the micro-scale projections and first recesses, and wherein the first recesses have a first depth of at least 100 µm and wherein the second recesses have a second depth of 0.2µm as taught by Ullrich, JR. et al. in order to provide the device with a surface roughness providing improved frictional characteristics and promote increased and efficient osteointegration within the device after implantation.
(With respect to the limitations “wherein said microscale projections and recesses are formed in a laser ablation process by a pulsed laser in the nanosecond range”, and “wherein said nano-scale structures are formed in a laser ablation process by a pulsed laser in the femtosecond range”, it is noted that the device of the combination appears to be substantially identical to the device claimed, although produced by a different process, therefore the burden is upon the applicant to come forward with evidence establishing an unobvious difference between the two. In re Marosi, 218 USPQ 289 (Fed. Cir. 1983). (See Paragraph [0020] of Lin, and Paragraphs [0050, 0069, 0076-0079] of Ullrich).
Regarding Claims 6-7 as best understood, the combination of Lamborne et al., Lin et al., and Ullrich, JR. et al. discloses the claimed invention as stated above in Claim 1, and Lamborne et al. further discloses wherein said cage comprises a quadrangular prism shape (Fig. 1A-1C) that includes said top surface, said bottom surface and a pair of spaced opposing side surfaces (left and right side surfaces formed by respective upper arm 110 and lower arm 120, Fig. 1A & 2A) that jointly define said hollow interior (Fig. 2A); wherein said top surface and said bottom surface each converge downwardly toward the distal end of said cage (at 111, Fig. 1A & 1C, Paragraph [0050]) and said opposing side surfaces are generally parallel along a portion of said cage between said proximal end and said distal end (Fig. 1B-1C).
Regarding Claims 8-10, the combination of Lamborne et al., Lin et al., and Ullrich, JR. et al. discloses the claimed invention as stated above in Claim 1, and Lamborne et al. further discloses wherein said cage has a top opening (top 113, Fig. 2A, Paragraph [0048]) extending through said top surface, and a bottom opening (bottom 123, Fig. 2B, Paragraph [0048]) extending through said bottom surface, said top opening and said bottom opening being in communication with said hollow interior of said cage (Figs. 2B, 3C); wherein said proximal end of said cage has a graft opening (aperture 132, Fig. 1B) therethrough in communication with hollow interior; and wherein said proximal end includes an attachment feature (threads within 132, Fig. 4B) for attachment to an implant insertion instrument (Paragraph [0057]).
Regarding Claim 12, the combination of Lamborne et al., Lin et al., and Ullrich, JR. et al. discloses the claimed invention as stated above in Claim 1, and Lamborne et al. further discloses wherein said cage comprises four movable arms defined by two upper arms and two lower arms (left and right side upper arms 110 and left and right side lower arms 120, Fig. 3C), each of said arms being attached to and projecting from a separate hinge point at said base (See examiner annotated Fig. 7C above).
Regarding Claim 13, the combination of Lamborne et al., Lin et al., and Ullrich, JR. et al. discloses the claimed invention as stated above in Claim 1, and Lamborne et al. further discloses wherein said expansion member comprises a wedge slidable within said hollow interior (Figs. 3A, 4B, 7C, Paragraphs [0050-0051]).
Regarding Claims 14-15 & 16-18 as best understood, Lamborne et al. discloses an interbody fusion device (spinal implant 100, Figs. 1A-20, Paragraphs [0047-0059]) comprising an expandable titanium cage (cage body, Fig. 1A, Paragraph [0078]) having a top surface (upper bone-contacting surface of 110, Fig. 1A) and an opposite bottom surface (lower bone-contacting surface of 120, Fig. 1A), a distal end (121, Fig. 1A) and a proximal end (122, Fig. 1A), a hollow interior (channel 150, Fig. 1A, 2A, 2B, 3B), and an operable expansion member (140, Figs. 3A-5B, Paragraphs [0050-0051]) within said hollow interior, said top surface and said bottom surface being movable away from each other to thereby expand said cage upon operation of the operable expansion member (upper arms 110 & lower arms 120 move away from each other when the wedge 140 moves distally as seen in Fig. 7C), and each of said top surface and said bottom surface including a textured surface (serrated portions of 110 & 120, Fig. 1A, 2A, 2B, Paragraph [0078]).
Lamborne et al. does not disclose each of said textured surfaces comprising: a laser ablated surface formed to have a three-dimensional geometric pattern defined by a plurality of micro-scale projections and first recesses; and an enhanced laser ablated surface on each of said laser ablated surfaces, each of said enhanced laser ablated surfaces being defined by a plurality of nano-scale structures on at least said projections; wherein said micro-scale projections and first recesses are formed in a laser ablation process by a pulsed laser in the nanosecond range to have a first depth of at least 100 µm; wherein said nano-scale structures comprise a plurality of stripe-shaped structures and second recesses, each of which has a length, said striped-shaped structures being spaced in a direction transverse to the respective lengths of said stripe-shaped structures by said second recesses; wherein said nano-scale structures are formed in a laser ablation process by a pulsed laser in the femtosecond range to have a second depth less than 1 pm; wherein said second depth is not greater than 200 nm. Lamborne et al. does disclose in Paragraph [0078] that “The implant material can optionally be chosen to enhance osseointegration between the implant and the living bone. For example, the components could be formed with a roughened surface texture or could be porous. PEEK, titanium or any other biocompatible material may provide adequate strength.”
Lin et al. discloses a titanium bone implant (100, Figs. 1-4 & 5B, Paragraphs [0016-0036]) comprising a textured surface (implant body 110 comprises at least one recess 110r, Fig. 4, Paragraphs [0027, 0035]) defined by least one laser ablated recess (110r) formed in the implant body (110, Paragraphs [0020, 0027, 0036], Fig. 4), wherein the diameter (D1, Fig. 4) of each recess “may depend on a diameter of the ultrafast laser light” (Paragraph [0027]) and wherein the depth (h, Fig. 4) of each recess is “may depend on energy and/or processing time of the ultrafast laser light”, wherein the textured surface comprises a laser ablated, three-dimensional pattern of micro-scale projections and first recesses formed thereon (microstructures 120 formed on inner sidewall of recess 110r in micrometer dimension in a regular pattern by ultrafast laser, Paragraphs [0020, 0036], Fig. 4), and a plurality of laser ablated nano-scale structures (microstructures 120 formed in nanometer dimension) (“the microstructures 120 may be formed in micrometer dimension, nanometer dimension or combination thereof.”, Paragraph [0020]), wherein said laser ablated nano-scale structures comprising a plurality of stripe-shaped structures and second recesses (Fig. 3, Paragraph [0025]), each of which has a length, said striped-shaped structures being spaced in a direction transverse to the respective lengths of said striped-shaped structures by said second recesses (Fig. 3, Paragraph [0025]). Lin et al. further discloses in Paragraphs [0016-0019] that “Under the processing of the ultrafast laser, a portion of a surface of the material of the implant body 110 may be removed, and the remained material forms a plurality of microstructures 120”, wherein “The microstructures 120 are formed on the surface of the implant body 110. Each microstructure 120 has a height H and a weight W, wherein the weight W is less than 2 micrometers, and the height H is less than 1 micrometer. Under such design, a surface area of the microstructure 120 may be increased, and accordingly the bone implant 100 has superhydrophilicity.”, and wherein “Due to the size design of the microstructures 120 of the present disclosure, the microstructures 120 can provide cells with a quality growing space, such that it is easy for the cells to grow and differentiate. In addition, due to the size design of the microstructures 120 of the present disclosure, the microstructures 120 vary in a small size range (such as nanometer scale) even if some microstructures 120 have large variations in size, and accordingly the large microstructures 120 do not unduly affect the growth and differentiation of the cells.” Lin et al. further discloses in Paragraph [0020] that “In an embodiment, the microstructures 120 may be formed by ultrafast laser light having infrared wavelength, and accordingly the microstructures 120 may be formed in micrometer dimension, nanometer dimension or combination thereof. Since the microstructures 120 may be formed by the ultrafast laser light, the microstructures 120 may be arranged in a regular pattern, and accordingly it is conducive to helping the cells to climb the bone implant 100 and uniformly grow. Due to the microstructures 120 are regularly arranged, the arithmetical mean deviation (Ra) of the implant body 110 of the microstructures 120 is less than 1 micrometer.” Lin et al. does not disclose that the nano-scale structures are on at least said micro-scale projections.
Ullrich et al. discloses devices and methods for producing bone implants having a roughened surface topography having a pattern designed to provide certain frictional characteristics, load dispersion, and to influence the biological responses that occur during bone healing and fusion (Abstract), wherein one particular embodiment of a titanium bone implant (spinal implant 1, Fig. 12, Paragraphs [0094-0097]) is depicted having top and bottom bone contacting surfaces (82, 82, Fig. 12) each including a textured surface (roughened topography 80, Paragraph [0095]), wherein the “The roughened surface topography 80 preferably includes micro features of a regular repeating pattern, formed during the subtractive or additive process, which may promote biological and chemical attachment or fusion with the bone structure.” (Paragraph [0102-0103, 0159]). Ullrich et al. discloses in Paragraph [0047] that “The shapes of the frictional surface protrusions or recesses provided by the subtractive process, additive process, or both processes form a roughened surface topography on at least one surface of the implant. The roughened surface topography preferably includes a predetermined repeating pattern. As used in this document, "predetermined" means determined beforehand, so that the predetermined characteristic must be determined, i.e., chosen or at least known, before use of the implant. The pattern may consist of an array of shapes or structures. The array may include a systematic arrangement of objects (e.g., dots, circles, ovals, squares, or strips) in rows, cmachining (e.g., milling, turning, or both techniques may be performed using machine tools, such as saws, lathes, milling machines, drill presses, or other equipment used with a sharp cutting tool to physically remove material to achieve a desired geometry); unmasked or masked etching (e.g., portions of the surface are protected by a masking material which resists etching and an etching substance is applied to unmasked portions); chemical, photo, electrical, electrochemical, plasma, or laser etching; cutting and removal processes; casting; forging; machining; drilling; grinding; shot peening; abrasive media blasting (such as sand or grit blasting); and combinations of these subtractive processes.” Paragraphs [0051- 0057] further discloses that the subtractive process may include “applying a temporary patterned mask before the subtractive process is performed. In other words, a mask may be applied to the desired surface, for example, to produce a desired pattern before implementing the subtractive technique. The pattern may include a designed configuration or array of dots, circles, semi-circles, squares, triangles, lines, strips, amorphous shapes, or any suitable pattern designed to provide frictional contact with opposing bones, dispersion loading, and to promote bone healing and fusion. Referring to the drawing, in which like reference numbers refer to like elements throughout the various figures that comprise the drawing, FIG. 1 depicts an embodiment of the invention where rows of maskant are applied in a first pattern 103 (e.g., dots or circles) on an original surface 104 of the implant 1.” And “The subtractive process may include a single subtractive step or multiple subtractive steps. The subtractive process may be applied sequentially, for example, to provide an array of shapes or structures recessed into the base surface.” “It is also envisioned that other angles (e.g., between 0 degree and 90 degree) may be produced in the overlapping patterns. After the pattern of maskant is applied, then an etchant may be applied, for example, to the portions of the original surface that are unprotected by the maskant.” (Figs. 2-3, 4B-4C, 6-7) Paragraph [0066] even further discloses “FIG. 10 shows an alternative example depicting an abraded surface detail which may be produced in an additive process, a subtractive process, or both processes. The three patterns may be applied simultaneously or sequentially to form a first pattern 103, a second pattern 105, and a third pattern 107 recessed into or projecting from the original surface 104. For example, the three patterns may form an overall repeating pattern on the surface of the implant 1.” Ullrich, JR. et al. further discloses in Paragraphs [0123-0124] a table depicting the macro, micro, and nano surface feature sizes and roughness, wherein the macro surface features have a depth between 40 and 500 µm with an average of 270 µm, wherein the micro surface features have a depth between 2 and 40 µm with an average of 11 µm, and wherein the nano surface features have a depth between 0.2 and 2 µm with an average of 1.1 µm.
Thus, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify each textured surface of the device of Lamborne et al. to add a laser ablated surface thereon comprising a three-dimensional geometric pattern made up of a combination of micro-scale projections and first recesses and a pattern of nano-scale stripe-shaped structures and second recesses, wherein the nano-scale striped-shaped structures are spaced in a direction transverse to the respective lengths of said striped-shaped structures by said second recesses as taught by Lin et al., wherein the plurality of nano-scale structures and recesses are formed on/overlap the micro-scale projections and first recesses, and wherein the first recesses have a first depth of at least 100 µm and wherein the second recesses have a second depth of 0.2µm as taught by Ullrich, JR. et al. in order to provide the device with a surface roughness providing improved frictional characteristics and promote increased and efficient osteointegration within the device after implantation.
(With respect to the limitations “wherein said microscale projections and recesses are formed in a laser ablation process by a pulsed laser in the nanosecond range”, and “wherein said nano-scale structures are formed in a laser ablation process by a pulsed laser in the femtosecond range”, it is noted that the device of the combination appears to be substantially identical to the device claimed, although produced by a different process, therefore the burden is upon the applicant to come forward with evidence establishing an unobvious difference between the two. In re Marosi, 218 USPQ 289 (Fed. Cir. 1983). (See Paragraph [0020] of Lin, and Paragraphs [0050, 0069, 0076-0079] of Ullrich).
Regarding Claims 19-20, the combination of Lamborne et al., Lin et al., and Ullrich, JR. et al. discloses the claimed invention as stated above in Claim 1, and Lamborne et al. further discloses wherein said cage has a top opening (top 113, Fig. 2A, Paragraph [0048]) extending through said top surface, and a bottom opening (bottom 123, Fig. 2B, Paragraph [0048]) extending through said bottom surface, said top opening and said bottom opening being in communication with said hollow interior of said cage (Figs. 2B, 3C), and wherein said proximal end of said cage has a graft opening (aperture 132, Fig. 1B) therethrough in communication with said hollow interior; and wherein said proximal end includes an attachment feature (threads within 132, Fig. 4B) for attachment to an implant insertion instrument (Paragraph [0057]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
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/JESSICA WEISS/Primary Examiner, Art Unit 3775
