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 Objections
Claim 14 is objected to because of the following informalities: In Line 13, a comma should be added at the end of the line. In Line 19, the limitation “said wall said” following the comma should be replaced with --said wall--. 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 1-13 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 1 at Line 16 recites the limitation “said pair of plates”. Claim 6 further recites “said pair of plates” in Line 4. There is insufficient antecedent basis for this limitation in the claims. For purposes of examination, each limitation is being interpreted as “said pair of porous portions”. Appropriate correction is required.
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.
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Claim 14 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 13, 16 & 17 of U.S. Patent No. 12,303,403 in view of Filippi et al. (US PG Pub No. 2011/0238185).
Claims 13, 16 & 17 of the patent disclose a spinal interbody fusion device, comprising: a monolithic, one-piece, unitary structure including an upper porous plate, an opposing lower porous plate, and a non-porous peripheral wall extending between and joining said upper porous plate and said opposing lower porous plate; said upper porous plate comprising a contact surface having an upper micro roughness for contacting an endplate of a vertebral body within an intradiscal space of a spine, said upper porous plate being formed by a 3-D printing process defining a plurality of pores extending entirely through said upper porous plate, an upper opening extending through said upper porous plate, a surface of at least a portion of said upper micro roughness comprising an augmented surface that includes a nano roughness; said lower porous plate comprising a contact surface having a lower micro roughness for contacting an endplate of an opposing vertebral body within the intradiscal space of the spine, said lower porous plate being formed by a 3-D printing process defining a plurality of pores extending entirely through said lower porous plate, a lower opening extending through said lower porous plate, a surface of at least a portion of said lower micro roughness comprising an augmented surface that includes a nano roughness; and said peripheral wall extending between and joining said upper porous plate and said lower porous plate, said upper porous plate, said lower porous plate, and said peripheral wall together defining a hollow interior of the unitary structure that is configured to receive bone graft, said opening through said upper porous plate, said opening through said lower porous plate, and said pores of said respective porous plates being in fluid communication with said hollow interior, wherein each of said openings extending through said respective upper porous plate and said lower porous plate is fully bounded and is separate and apart from said pores of said respective plate, each of said openings having a dimension larger than a dimension of any of said pores of said upper porous plate and said lower porous plate; wherein said peripheral wall comprises a bellows shaped shell that is angled or curved inwardly between said upper porous plate and said lower porous plate at an inclusive angle, β; and wherein said spinal interbody fusion device comprises titanium or a titanium alloy, and wherein said peripheral wall has a thickness in the range of 0.5 mm to 1.0 mm.
The patent does not disclose said shell having a cut-out portion exposing said hollow interior.
Filippi et al. discloses an intervertebral implant comprising an upper plate, a lower plate, and a bellows shaped shell located therebetween, wherein the shell comprises a cutout exposing a hollow interior defined between a wall of the shell, the upper plate and the lower plate.
It would have been obvious to modify the patent to include a cutout exposing the hollow interior of the fusion device in order to provide the device with a direct means for insertion of liquid bone graft into the hollow interior as needed.
Claim 14 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 12, 15 & 16 of U.S. Patent No. 12,303,402 in view of Filippi et al. (US PG Pub No. 2011/0238185).
Claims 12, 15 & 16 of the patent disclose a spinal implant interbody fusion device, comprising: a one-piece, unitary structure including: an upper porous portion comprising a contact surface having an upper micro roughness for contacting an endplate of a vertebral body within an intradiscal space of a spine, said upper porous portion being formed by a 3-D printing process defining a plurality of pores extending through said upper porous portion, an upper opening fully bounded and separate from said pores through said upper porous portion and extending entirely through said upper porous portion, a surface of at least a portion of said upper micro roughness comprising an augmented surface that includes a nano roughness; a lower porous portion comprising a contact surface having a lower micro roughness for contacting an endplate of an endplate of an opposing vertebral body within an intradiscal space of a spine, said lower porous portion being formed by a 3-D printing process defining a plurality of pores extending through said lower porous portion, a lower opening fully bounded and separate from said pores through said lower porous portion and extending entirely through said lower porous portion, a surface of at least a portion of said lower micro roughness comprising an augmented surface that includes a nano roughness; and a non-porous peripheral wall extending between and joining said upper porous portion and said lower porous portion, said upper porous portion, said lower porous portion, and said peripheral wall together defining a hollow interior of the one-piece, unitary structure that is configured to receive bone graft, said opening through said upper porous portion, said opening through said lower porous portion, and pores of said respective porous portions being in fluid communication with said hollow interior; and wherein said spinal interbody fusion device has a height extending along a height direction, and wherein each of said porous portions has a thickness in the height direction, said thickness of each porous portion ranging from 10% to 50% of said height of said spinal interbody fusion device; wherein said peripheral wall comprises a bellows shaped shell that is angled or curved inwardly between said upper porous portion and said lower porous portion at an inclusive angle, β; and wherein said spinal interbody fusion device comprises titanium or a titanium alloy, and wherein said peripheral wall has a thickness in the range of 0.5 mm to 1.0 mm.
The patent does not disclose said shell having a cut-out portion exposing said hollow interior.
Filippi et al. discloses an intervertebral implant comprising an upper plate, a lower plate, and a bellows shaped shell located therebetween, wherein the shell comprises a cutout exposing a hollow interior defined between a wall of the shell, the upper plate and the lower plate.
It would have been obvious to modify the patent to include a cutout exposing the hollow interior of the fusion device in order to provide the device with a direct means for insertion of liquid bone graft into the hollow interior as needed.
Claim 14 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of U.S. Patent No. 12,161,565 in view of Filippi et al. (US PG Pub No. 2011/0238185).
Claims 1-8 of the patent disclose a spinal interbody fusion device, comprising: a one-piece integral structure including a pair of plates and a non-porous bellows shaped shell extending between and joining said pair of plates, each plate being configured to contact a respective opposing vertebral body within an intradiscal space of a spine, each plate comprising a porous contact region for contacting a respective vertebral body, each of said porous contact regions having a plurality of pores, one or more of said pores extending through said porous contact regions, an outer surface of at least a portion of each of said pair of plates comprising a textured surface that includes a plurality of nano-structures, said bellows shaped shell including a wall extending therearound that defines a hollow interior that is configured to receive bone graft, said pores of said pair of plates being in communication with said hollow interior for through growth fusion of bone graft to said respective opposing vertebral bodies, said wall being angled or curved inwardly between said pair of plates; wherein said one-piece integral structure comprises an additive manufactured structure; wherein said one-piece integral structure comprises a 3D printed additive manufactured structure; wherein said pair of plates and said bellows shaped shell are 3-D printed as a one-piece integral structure of titanium or a titanium alloy, said wall of said bellows shaped shell having a thickness in the range of 0.5 mm to 1.0 mm; wherein said spinal interbody fusion device is configured for use in an anterior lumbar interbody fusion (ALIF) procedure and wherein each of said pair of plates comprises a quadrilateral perimeter; wherein each of said pair of plates has, in addition to said pores, an opening extending therethrough in communication with said hollow interior of said shell; wherein the wall of said bellows shaped shell comprises only a single portion that is angled or curved inwardly between said pair of plates at an inclusive angle beta, β in a range from 69° to 120°; and wherein said spinal interbody fusion device further includes bone graft contained within said hollow interior, said bone graft communicating with said pores of each of said pair of plates and said at least one opening of each of said pair of plates to promote fusion between said opposing vertebral bodies through said spinal interbody fusion device.
The patent does not disclose said shell having a cut-out portion exposing said hollow interior.
Filippi et al. discloses an intervertebral implant comprising an upper plate, a lower plate, and a bellows shaped shell located therebetween, wherein the shell comprises a cutout exposing a hollow interior defined between a wall of the shell, the upper plate and the lower plate.
It would have been obvious to modify the patent to include a cutout exposing the hollow interior of the fusion device in order to provide the device with a direct means for insertion of liquid bone graft into the hollow interior as needed.
Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over Claims 14-20 of U.S. Patent No. 11,826,265 in view of Ullrich, JR. et al. (US PG Pub No. 2011/0282454).
Claims 14-20 of the patent disclose a spinal interbody fusion device, comprising: a 3-D printed one-piece integral structure of titanium or a titanium alloy configured for use in a transforaminal lumbar interbody fusion (TLIF) procedure, including an upper plate, a lower plate, and a non-porous bellows shaped shell, said upper plate comprising a porous contact region for contacting a vertebral body within an intradiscal space of a spine, said upper plate porous contact region including a three-dimensional gyroid lattice structure defined by a plurality of struts and pores, one or more of said upper plate pores extending through said upper plate porous contact region, said upper plate having, in addition to said upper plate pores, at least one opening extending therethrough; an outer surface of at least a portion of said upper plate struts comprising a textured surface, said upper plate comprising an arcuate, generally oblong perimeter; said lower plate comprising a porous contact region for contacting a vertebral body within an intradiscal space of a spine, said lower plate porous contact region including a three-dimensional gyroid lattice structure defined by a plurality of struts and pores, one or more of said lower plate pores extending through said lower plate porous contact region, said lower plate having, in addition to said lower plate pores, at least one opening extending therethrough; an outer surface of at least a portion of said lower plate struts comprising a textured surface, said lower plate comprising an arcuate, generally oblong perimeter; and said non-porous bellows shaped shell extending between and joining said upper plate and said lower plate, said bellows shaped shell including a wall extending therearound that defines a hollow interior in communication with said upper plate pores and said opening of said upper plate and in communication with said lower plate pores and said opening of said lower plate, said wall being angled or curved between said upper plate and said lower plate, said wall of said bellows shaped shell having a thickness in the range of 0.5 mm to 1.0 mm, wherein said bellows shaped shell has a cut-out portion exposing said hollow interior of said bellows shaped shell, and wherein said spinal interbody fusion device has a first curved end and an opposite second curved end; wherein the wall of said bellows shaped shell is angled or curved inwardly between said upper plate and said lower plate at an inclusive angle beta, β; wherein said spinal interbody fusion device further includes a fixed post disposed adjacent one of said first curved end or said second curved end and extending between said pair of plates, said fixed post being accessible through said cut-out portion of said bellows shaped shell; wherein said spinal interbody fusion device further includes a pivot post rotatably disposed between said pair of plates and between said first curved end and said second curved end, said spinal interbody fusion device being rotatable about said pivot post; wherein said pivot post is accessible through said cut-out portion of said bellows shaped shell for receipt of an installation tool for insertion of said spinal interbody fusion device into said intradiscal space; wherein said pivot post comprises a threaded aperture for threadably receiving a threaded portion of said installation tool; and wherein an outer surface of at least a portion of said struts of the porous contact regions of said upper plate and said lower plate comprises a laser ablated textured surface.
Claims 14-20 of the patent do not disclose each contact surface including a micro roughness having a plurality of pores, and a surface of at least a portion of each said micro roughness comprising an augmented surface that includes a nano roughness.
Ullrich, JR. et al. discloses an interbody spinal implant comprising an upper plate, a lower plate, and a peripheral wall extending therebetween, wherein the upper and lower plates comprise contact surfaces with a roughened surface topography comprising any combination of macro, micro and nano textures which provide a better grip to vertebral endplate surfaces and inhibit implant migration upon placement and seating.
It would have been obvious to modify the porous contact surfaces of the patent with a combination micro and nano roughness as taught by Ullrich, JR. et al. in order to help prevent implant migration after implantation and provide a better grip with adjacent vertebrae.
Claim 14 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 14-15 of U.S. Patent No. 11,826,265.
Although the claims at issue are not identical, they are not patentably distinct from each other because:
Claim 14 of the application recites a spinal interbody fusion device, comprising: a 3-D printed integral structure comprising an upper plate, a lower plate and a bellows shaped shell; said upper plate comprising an upper porous contact region for contacting a first vertebral body within an intradiscal space of a spine, said upper porous contact region having a plurality of pores extending therethrough, said upper porous contact region having an upper opening separate and apart from said upper plate pores and extending entirely through said upper porous contact region, said lower plate comprising a lower porous contact region for contacting a second vertebral body within said intradiscal space, said lower porous contact region having a plurality of pores extending therethrough, said lower porous contact region having a lower opening separate and apart from said lower plate pores and extending entirely through said lower porous contact region said bellows shaped shell extending between and joining said upper plate and said lower plate, said bellows shaped shell including a non-porous wall extending therearound that together with said upper plate and said lower plate defines a hollow interior that is configured to receive bone graft, said upper plate pores, said lower plate pores, said upper opening and said lower opening being in fluid communication with said hollow interior for through growth fusion of bone graft to said respective first and second vertebral bodies, said wall said of said shell having a thickness in the range of 0.5 mm to 1.0 mm and being angled or curved between said upper plate and said lower plate (See Claim 15 of the patent), said shell having a cut-out portion exposing said hollow interior (See Claim 14 of the patent).
Claim 14 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 & 8 of U.S. Patent No. 11,701,241 in view of Filippi et al. (US PG Pub No. 2011/0238185).
Claims 1-4 & 8 of the patent discloses a bellows shaped spinal implant, comprising: an upper plate having an outer upper contact surface and at least one upper opening therethrough; a lower plate having an outer lower contact surface and at least one lower opening therethrough; and a bellows shaped shell extending between and joining said upper plate and said lower plate, said bellows shaped shell being formed of titanium or an alloy comprising titanium and including a wall extending therearound that defines a hollow interior in communication with said at least one upper opening and said at least one lower opening, said wall having a thickness in the range of 0.5 mm to 1.0 mm, said wall being angled or curved between said upper plate and said lower plate, said wall including an insertion portion having a thickness greater than the thickness of the remainder of said wall, said insertion portion comprising a hole formed therethrough in communication with said hollow interior of said bellows shaped shell, and said hole configured for introducing bone graft into the hollow interior of said bellows shaped shell; wherein said outer upper contact surface and said outer lower contact surface each include a porous surface comprising a micro roughness; wherein said porous surface of each of said outer upper contact surface and said outer lower contact surface is 3-D printed defining a plurality of pores therethrough in communication with said hollow interior; wherein said porous surface of each of said outer upper contact surface and said outer lower contact surface further comprises a nano roughness; and wherein said upper plate, said lower plate and said bellows shaped shell are formed unitarily as a one-piece bellows shaped spinal implant.
The patent does not disclose said shell having a cut-out portion exposing said hollow interior.
Filippi et al. discloses an intervertebral implant comprising an upper plate, a lower plate, and a bellows shaped shell located therebetween, wherein the shell comprises a cutout exposing a hollow interior defined between a wall of the shell, the upper plate and the lower plate.
It would have been obvious to modify the patent to include a cutout exposing the hollow interior of the fusion device in order to provide the device with a direct means for insertion of liquid bone graft into the hollow interior as needed.
Allowable Subject Matter
Claims 1-13 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action (See double patenting rejection above for Claim 1.)
Claims 14-20 allowed. (See claim objection and double patenting rejections above for Claim 14.)
The closest prior art of record appears to be: Gauchet et al. (US Patent No. 6,579,320). Gauchet et al. discloses an intervertebral disc prosthesis comprising porous upper and lower endplates, and a cylindrical body and a compressible bellows therebetween, wherein the bellows includes a wall defining a hollow interior, but Gauchet et al. fails to disclose that the endplates each comprise a contact region including a micro roughness including a surface comprising an augmented surface with a nano roughness, and wherein the hollow interior of the bellows wall is configured to receive bone graft for through growth fusion of bone graft to respective opposing vertebral bodies, and a pivot post rotatably disposed between said pair of opposing portions within said hollow interior. Furthermore, there is no reasonable motivation to modify Gauchet et al. with the claimed features since the prosthesis is intended to imitate the behavior of a healthy natural intervertebral disc and is not intended for spinal fusion.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JESSICA WEISS whose telephone number is (571) 270-5597. The examiner can normally be reached Monday through Friday, 8:00 am to 4:00 pm EST. If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, KEVIN T. TRUONG, at 571-272-4705. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/JESSICA WEISS/Primary Examiner, Art Unit 3775
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