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, 2, 4, 10-12, & 15-18 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 4, 17 & 21 of related U.S. Patent No. 12,185,998.
Although the claims at issue are not identical, they are not patentably distinct from each other because:
Claim 1 of the application recites a bone screw (See Line 1 of Claim 1 of the patent) comprising: a shaft defining a longitudinal axis (See Line 2 of Claim 1 of the patent), the shaft comprising a first portion and a second portion (See Lines 2-3 of Claim 1 of the patent), a threaded section extending along at least part of the first portion and the second portion (See Lines 3-4 of Claim 1 of the patent), the second portion comprising an inner core and a wall disposed about the inner core (See Lines 4-6 of Claim 1 of the patent); at least a portion of the wall comprising a trabecular configuration (See Lines 8-9 of Claim 1 of the patent); and wherein a portion of the threaded section extends outwardly from the wall (See Lines 13-14 of Claim 1 of the patent).
As to Claims 2, 4, & 10-12 of the application: The limitations of Claims 2, 4, & 10 are found in Claim 1 of the patent. The limitations of Claim 11 are found in Claim 2 of the patent. The limitations of Claim 12 are found in Claim 4 of the patent.
Claim 15 of the application recites a bone screw (See Line 1 of Claim 17 of the patent) comprising: a shaft defining a longitudinal axis (See Line 2 of Claim 17 of the patent), the shaft including a first portion and a second portion (See Lines 2-3 of Claim 17 of the patent), a threaded section disposed along the first portion and the second portion (See Lines 3-5 of Claim 17 of the patent), the second portion comprising an inner core and a wall disposed about the inner core (See Lines 4-6 of Claim 17 of the patent); at least a portion of the threaded section extending outwardly from the wall around the second portion of the shaft (See Lines 6-7 of Claim 17 of the patent), the wall comprising a surface (See Lines 7-8 of Claim 17 of the patent), a plurality of spaced apart struts and a plurality of lattices disposed between the struts, the struts comprising a solid surface, the lattices comprising a plurality of nodes and openings; and wherein the nodes and openings of the lattices are disposed in a predetermined orientation (See Lines 10-14 of Claim 17 of the patent).
As to Claims 16-17 of the application: The limitations of Claims 16-17 are found in Claim 1 of the patent.
Claim 18 of the application recites a bone screw (See Line 1 of Claim 21 of the patent)comprising: a shaft defining a longitudinal axis (See Line 2 of Claim 21 of the patent), the shaft including at least a first portion and a second portion (See Lines 2-3 of Claim 21 of the patent), the second portion comprising an inner core and a wall disposed about the inner core, the wall comprising a surface (See Lines 3-5 of Claim 21 of the patent), the wall defining a plurality of spaced apart struts, and lattices positioned between the struts, the struts comprising a solid surface, and a threaded section disposed along the first portion and the second portion, a portion of the threaded section and extending from the wall, and the struts and lattices disposed in a predetermined orientation along the wall (See Lines 5-12 of Claim 21 of the patent).
Claim Objections
Claim 8 is objected to because of the following informalities: In Line 1, the words “is fabricated to be” should be replaced with the words --threads are-- as the specification recites that it is the distal tip threads which are self-tapping or intermittent. Appropriate correction is required.
Claim 16 is objected to because of the following informalities: In Line 1, the word –the-- should be added before the word “nodes” since “the nodes” were previously recited in independent Claim 15. Appropriate correction is required.
Claim 18 is objected to because of the following informalities:
In Line 5, the first comma should be deleted as it appears to be a typo.
In Line 8, the first instance of the word “and” should be deleted as it appears to be a typo. Appropriate correction is required.
Claim 19 is objected to because of the following informalities: In Line 1, a comma should be added immediately following the number “18”. Appropriate correction is required.
Claim 20 is objected to because of the following informalities: In Line 1, a comma should be added immediately following the number “18”. 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 Armstrong et al. (US PG Pub No. 2014/0012334) in view of Steinmann et al. (US PG Pub No. 2015/0018956).
Regarding Claims 1, 2, 10, 11 & 13-14, Armstrong et al. discloses a bone screw (bone fastener 30, Figs. 1-2, Paragraphs [0005-0029]) comprising: a shaft (elongated shaft, not labeled, extending from 62 to 54, Fig. 1) defining a longitudinal axis (axis a, Fig. 1), the shaft comprising a first portion (upper portion including head 60 and proximal/third zone 36, Fig. 1, Paragraph [0019]) and a second portion (lower portion including distal zone 32 and central zone 34, Fig. 1), a threaded section (externally threaded portion of 30 including upper threads 44, 42, and lower threads 44, Fig. 1, Paragraph [0020-0022]) extending along at least part of the first portion and the second portion, wherein the threaded section comprises a first segment (upper threaded segment 44 within zone 36, Fig. 1) disposed along the first portion and a second segment (threaded segment 42 within zone 34 and lower threaded segment 44 within zone 32, Fig. 1) disposed along the second portion, the second portion comprising an inner core (longitudinal bore through shaft, not labeled, “bone fastener 30 has a longitudinal bore extending through the length of bone fastener 30 such that bone fastener 30 is cannulated along axis a.”, Paragraph [0019]) and a wall (external wall 40 of shaft extending between threads, Fig. 1) disposed about the inner core; and wherein a portion of the threaded section extends outwardly from the wall (threads 44, 42 & 44 are external threads formed along the external wall of 40, Fig. 1).
Armstrong et al. does not disclose at least a portion of the wall comprising a trabecular configuration, wherein at least a portion of the wall comprises a plurality of spaced apart struts comprising a solid surface and lattices positioned between at least some of the struts, wherein the lattices define at least a portion of the threaded section around the second segment, and wherein the threaded section comprises a porous area that at least partially overlaps with the trabecular configuration of the wall, and wherein the trabecular configuration extends from an outer portion of the wall to the inner core.
Armstrong et al. does disclose in Paragraph [0017] that “The components of the bone fastener of the present disclosure are fabricated from materials suitable for medical applications, including metals, polymers, ceramics, biocompatible materials and/or their composites, depending on the particular application and/or preference of a medical practitioner. For example, the bone fastener can be fabricated from materials such as commercially pure titanium, titanium alloys, Grade 5 titanium, super-elastic titanium alloys, cobalt-chrome alloys, stainless steel alloys, superelastic metallic alloys (e.g. Nitinol, super elasto-plastic metals, such as GUM METAL.RTM. manufactured by Toyota Material Incorporated of Japan), thermoplastics such as polyaryletherketone (PAEK) including polyetheretherketone (PEEK), polyetherketoneketone (PEKK) and polyetherketone (PEK), carbon fiber reinforced PEEK composites, PEEK-BaSO.sub.4 composites, ceramics and composites thereof such as calcium phosphate (e.g. SKELITE.TM. manufactured by Biologix Inc.), rigid polymers including polyphenylene, polyamide, polyimide, polyetherimide, polyethylene, polyurethanes of any durometer, epoxy and silicone. The bone fastener may also be fabricated from a heterogeneous material such as a combination of two or more of the above-described materials to achieve various desired characteristics such as strength, rigidity, elasticity, compliance, biomechanical performance, durability and radiolucency or imaging preference.”
Steinmann et al. discloses various metal surgical implant devices comprising a body portion/primary structure and one or more osteoporous/osteoderived/trabecular surfaces formed by an additive manufacturing process (Abstract, Paragraph [0056]), wherein the osteoporous/osteoderived/trabecular surfaces comprise at least one needle-populated, metallic surface portion formed on at least one exterior portion of the osteoporous/osteoderived/trabecular surface which provides an increased coefficient of friction and a stronger initial fixation which is important before bone is able to grow onto/into the porous structure (Paragraph [0078]), the one or more osteoporous/osteoderived/trabecular surfaces located such that it engages with a patient's bone when the implant is implanted in the patient (Paragraph [0075]), wherein “The primary structure may comprise, for example, a dental implant, a foot-and-ankle or long-bone osteotomy wedge, an intervertebral fusion device, a tibial/femoral augment or spacer, a tibial tray portion of a knee implant, a femoral component portion of a knee implant, a primary hip implant, a revision hip implant, a hip trauma component, an acetabular cup, a hip acetabular augment, or other appropriate structure.” (Paragraph [0056-0057]) and wherein a bone screw (500, Paragraph [0087]) is depicted as one of the embodiments in Fig. 20. Figs. 8A-D depict an illustrative irregular (e.g., trabecular, osteo-porous, and/or osteo-derived) unit cell appropriate for additive manufacture in accordance with the invention, wherein Figs. 9A-9L depict renderings of an osteoporous surface in various lattice configurations which can be used on any sort of medical implants (Paragraph [0066]), the lattice configurations comprising a plurality of spaced apart solid struts with lattices positioned between at least some of the struts (See examiner annotated Figs. 9I-9J below), and wherein Figs. 10A-11B depict images of porous implant sections that have/have not undergone abrasive blasting to create a microtexture which helps osteoblasts adhere to the titanium struts (Paragraph [0064]), and wherein Fig. 20 depicts the bone screw (500, Paragraph [0087]) incorporating both porous regions 502 and non-porous regions 504, wherein the porous regions are disposed at the threads to promote bony purchase, and wherein in one embodiment which depicts a cage (10), the cage consists of a unitary structure that is substantially solid in the middle and graduates to porous at given surfaces which “provides enhanced structural integrity and allows for the porosity to be carefully controlled in a given area, etc.” “or there may be a relatively sharp dividing line between the solid portion and the porous portions, although it is contemplated that they are integrally formed via the additive manufacturing technique.” (Paragraph [0072])
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It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the bone screw of Armstrong et al. so that the second zone 34, including the shaft wall and the threads 42 for engaging with cancellous bone, comprises a modified metallic osteoporous/osteoderived/trabecular surface extending from an outermost surface the inner core and defined by a plurality of struts and lattices positioned therebetween as taught by Steinmann et al. in order to promote increased bone purchased between the screw and the cancellous bone after implantation.
Regarding Claim 3, the combination of Armstrong et al. and Steinmann et al. discloses the claimed invention as stated above in claim 2, and Armstrong et al. further discloses wherein the first segment of the threaded section comprises continuous threads (upper threaded segment 44 within zone 36, Fig. 1).
Regarding Claim 4, the combination of Armstrong et al. and Steinmann et al. discloses the claimed invention as stated above in claim 2, and Armstrong et al. further discloses wherein the first segment of the threaded section is disposed adjacent to a proximal end of the shaft (upper threaded segment 44 within zone 36 is adjacent the proximal-most end 62 of the shaft, Fig. 1).
Regarding Claim 5, the combination of Armstrong et al. and Steinmann et al. discloses the claimed invention as stated above in claim 2, and Armstrong et al. further discloses wherein threads of the second segment are staggered (lower threaded segment 44 within zone 32 has twice as many threads as the threaded segment 42 within zone 34, Fig. 1, Paragraphs [0020-0021]).
Regarding Claim 6, the combination of Armstrong et al. and Steinmann et al. discloses the claimed invention as stated above in claim 1, and Armstrong et al. further discloses a distal tip (54, Fig. 1) with a solid outer surface (The distal tip 54 is not porous and thus it is considered solid).
Regarding Claim 7, the combination of Armstrong et al. and Steinmann et al. discloses the claimed invention as stated above in claim 6, and Armstrong et al. further discloses wherein the distal tip comprises threads (lower threads 44 in zone 32 extend all the way to the tip 54 as seen in Fig. 1).
Regarding Claim 8, the combination of Armstrong et al. and Steinmann et al. discloses the claimed invention as stated above in claim 7, and Armstrong et al. further discloses wherein the distal tip is self-tapping (Paragraphs [0009, 0025, 0027]).
Regarding Claim 9, the combination of Armstrong et al. and Steinmann et al. discloses the claimed invention as stated above in claim 6, and Armstrong et al. further discloses wherein the distal tip is tapered (Fig. 1).
Regarding Claim 12, the combination of Armstrong et al. and Steinmann et al. discloses the claimed invention as stated above in claim 2, and Armstrong et al. further discloses wherein the threaded section comprises non-porous threads around the first segment (threads of the upper threaded segment 44 within zone 36 are not porous as seen in Fig. 1).
Regarding Claims 15-17, Armstrong et al. discloses a bone screw (bone fastener 30, Figs. 1-2, Paragraphs [0005-0029]) comprising: a shaft (elongated shaft, not labeled, extending from 62 to 54, Fig. 1) defining a longitudinal axis (axis a, Fig. 1), the shaft including a first portion (upper portion including head 60 and proximal/third zone 36, Fig. 1, Paragraph [0019]) and a second portion (lower portion including distal zone 32 and central zone 34, Fig. 1), a threaded section (externally threaded portion of 30 including upper threads 44, 42, and lower threads 44, Fig. 1, Paragraph [0020-0022]) disposed along the first portion and the second portion, the second portion comprising an inner core (longitudinal bore through shaft, not labeled, “bone fastener 30 has a longitudinal bore extending through the length of bone fastener 30 such that bone fastener 30 is cannulated along axis a.”, Paragraph [0019]) and a wall (external wall 40 of shaft extending between threads, Fig. 1) disposed about the inner core; at least a portion of the threaded section extending outwardly from the wall around the second portion of the shaft (threads 42 in 34 & 44 in 32 are external threads formed along the external wall of 40, Fig. 1), the wall comprising a surface (outermost surface of external wall 40 defining roots between each adjacent thread turn, Fig. 1).
Armstrong et al. does not disclose the wall comprising a plurality of spaced apart struts and a plurality of lattices disposed between the struts, the struts comprising a solid surface, the lattices comprising a plurality of nodes and openings, wherein the nodes and openings of the lattices are disposed in a predetermined orientation, wherein nodes and openings are disposed in rows, columns or a random configuration, and wherein the nodes and openings are disposed in a series orientation or a parallel orientation.
Armstrong et al. does disclose in Paragraph [0017] that “The components of the bone fastener of the present disclosure are fabricated from materials suitable for medical applications, including metals, polymers, ceramics, biocompatible materials and/or their composites, depending on the particular application and/or preference of a medical practitioner. For example, the bone fastener can be fabricated from materials such as commercially pure titanium, titanium alloys, Grade 5 titanium, super-elastic titanium alloys, cobalt-chrome alloys, stainless steel alloys, superelastic metallic alloys (e.g. Nitinol, super elasto-plastic metals, such as GUM METAL.RTM. manufactured by Toyota Material Incorporated of Japan), thermoplastics such as polyaryletherketone (PAEK) including polyetheretherketone (PEEK), polyetherketoneketone (PEKK) and polyetherketone (PEK), carbon fiber reinforced PEEK composites, PEEK-BaSO.sub.4 composites, ceramics and composites thereof such as calcium phosphate (e.g. SKELITE.TM. manufactured by Biologix Inc.), rigid polymers including polyphenylene, polyamide, polyimide, polyetherimide, polyethylene, polyurethanes of any durometer, epoxy and silicone. The bone fastener may also be fabricated from a heterogeneous material such as a combination of two or more of the above-described materials to achieve various desired characteristics such as strength, rigidity, elasticity, compliance, biomechanical performance, durability and radiolucency or imaging preference.”
Steinmann et al. discloses various metal surgical implant devices comprising a body portion/primary structure and one or more osteoporous/osteoderived/trabecular surfaces formed by an additive manufacturing process (Abstract, Paragraph [0056]), wherein the osteoporous/osteoderived/trabecular surfaces comprise at least one needle-populated, metallic surface portion formed on at least one exterior portion of the osteoporous/osteoderived/trabecular surface which provides an increased coefficient of friction and a stronger initial fixation which is important before bone is able to grow onto/into the porous structure (Paragraph [0078]), the one or more osteoporous/osteoderived/trabecular surfaces located such that it engages with a patient's bone when the implant is implanted in the patient (Paragraph [0075]), wherein “The primary structure may comprise, for example, a dental implant, a foot-and-ankle or long-bone osteotomy wedge, an intervertebral fusion device, a tibial/femoral augment or spacer, a tibial tray portion of a knee implant, a femoral component portion of a knee implant, a primary hip implant, a revision hip implant, a hip trauma component, an acetabular cup, a hip acetabular augment, or other appropriate structure.” (Paragraph [0056-0057]) and wherein a bone screw (500, Paragraph [0087]) is depicted as one of the embodiments in Fig. 20. Figs. 8A-D depict an illustrative irregular (e.g., trabecular, osteo-porous, and/or osteo-derived) unit cell appropriate for additive manufacture in accordance with the invention, wherein Figs. 9A-9L depict renderings of an osteoporous surface in various lattice configurations which can be used on any sort of medical implants (Paragraph [0066]), the lattice configurations comprising a plurality of spaced apart solid struts with lattices positioned between the struts (See examiner annotated Figs. 9I-9J below), the lattices comprising a plurality of nodes and openings disposed in a predetermined orientation, wherein nodes and openings are disposed in rows and columns, and in a parallel orientation (See examiner annotated Fig. 9I above), and wherein Figs. 10A-11B depict images of porous implant sections that have/have not undergone abrasive blasting to create a microtexture which helps osteoblasts adhere to the titanium struts (Paragraph [0064]), and wherein Fig. 20 depicts the bone screw (500, Paragraph [0087]) incorporating both porous regions 502 and non-porous regions 504, wherein the porous regions are disposed at the threads to promote bony purchase, and wherein in one embodiment which depicts a cage (10), the cage consists of a unitary structure that is substantially solid in the middle and graduates to porous at given surfaces which “provides enhanced structural integrity and allows for the porosity to be carefully controlled in a given area, etc.” “or there may be a relatively sharp dividing line between the solid portion and the porous portions, although it is contemplated that they are integrally formed via the additive manufacturing technique.” (Paragraph [0072])
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It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the bone screw of Armstrong et al. so that the second zone 34, including the shaft wall and the threads 42 for engaging with cancellous bone, comprises a modified metallic osteoporous/osteoderived/trabecular surface extending from an outermost surface the inner core and defined by a plurality of struts and lattices positioned therebetween disposed in parallel rows/columns as taught by Steinmann et al. in order to promote increased bone purchased between the screw and the cancellous bone after implantation.
Regarding Claims 18-20, Armstrong et al. discloses a bone screw (bone fastener 30, Figs. 1-2, Paragraphs [0005-0029]) comprising: a shaft (elongated shaft, not labeled, extending from 62 to 54, Fig. 1) defining a longitudinal axis (axis a, Fig. 1), the shaft including a first portion (upper portion including head 60 and proximal/third zone 36, Fig. 1, Paragraph [0019]) and a second portion (lower portion including distal zone 32 and central zone 34, Fig. 1), the second portion comprising an inner core (longitudinal bore through shaft, not labeled, “bone fastener 30 has a longitudinal bore extending through the length of bone fastener 30 such that bone fastener 30 is cannulated along axis a.”, Paragraph [0019]) and a wall (external wall 40 of shaft extending between threads, Fig. 1) disposed about the inner core, the wall comprising a surface (outermost surface of external wall 40 defining roots between each adjacent thread turn, Fig. 1), and a threaded section (externally threaded portion of 30 including upper threads 44, 42, and lower threads 44, Fig. 1, Paragraph [0020-0022]) disposed along the first portion and the second portion, a portion of the threaded section extending from the wall (threads 42 in 34 & 44 in 32 are external threads formed along the external wall of 40, Fig. 1).
Armstrong et al. does not disclose the wall defining a plurality of spaced apart struts and lattices positioned between the struts, the struts comprising a solid surface, and the struts and lattices disposed in a predetermined orientation along the wall, wherein the predetermined orientation comprises at least one layer of lattices disposed in a parallel orientation along the wall, wherein the shaft and the threaded section are manufactured by an additive manufacturing method comprising 3-D printing.
Armstrong et al. does disclose in Paragraph [0017] that “The components of the bone fastener of the present disclosure are fabricated from materials suitable for medical applications, including metals, polymers, ceramics, biocompatible materials and/or their composites, depending on the particular application and/or preference of a medical practitioner. For example, the bone fastener can be fabricated from materials such as commercially pure titanium, titanium alloys, Grade 5 titanium, super-elastic titanium alloys, cobalt-chrome alloys, stainless steel alloys, superelastic metallic alloys (e.g. Nitinol, super elasto-plastic metals, such as GUM METAL.RTM. manufactured by Toyota Material Incorporated of Japan), thermoplastics such as polyaryletherketone (PAEK) including polyetheretherketone (PEEK), polyetherketoneketone (PEKK) and polyetherketone (PEK), carbon fiber reinforced PEEK composites, PEEK-BaSO.sub.4 composites, ceramics and composites thereof such as calcium phosphate (e.g. SKELITE.TM. manufactured by Biologix Inc.), rigid polymers including polyphenylene, polyamide, polyimide, polyetherimide, polyethylene, polyurethanes of any durometer, epoxy and silicone. The bone fastener may also be fabricated from a heterogeneous material such as a combination of two or more of the above-described materials to achieve various desired characteristics such as strength, rigidity, elasticity, compliance, biomechanical performance, durability and radiolucency or imaging preference.”
Steinmann et al. discloses various metal surgical implant devices comprising a body portion/primary structure and one or more osteoporous/osteoderived/trabecular surfaces formed by an additive manufacturing process (Abstract, Paragraph [0056]), wherein the osteoporous/osteoderived/trabecular surfaces comprise at least one needle-populated, metallic surface portion formed on at least one exterior portion of the osteoporous/osteoderived/trabecular surface which provides an increased coefficient of friction and a stronger initial fixation which is important before bone is able to grow onto/into the porous structure (Paragraph [0078]), the one or more osteoporous/osteoderived/trabecular surfaces located such that it engages with a patient's bone when the implant is implanted in the patient (Paragraph [0075]), wherein “The primary structure may comprise, for example, a dental implant, a foot-and-ankle or long-bone osteotomy wedge, an intervertebral fusion device, a tibial/femoral augment or spacer, a tibial tray portion of a knee implant, a femoral component portion of a knee implant, a primary hip implant, a revision hip implant, a hip trauma component, an acetabular cup, a hip acetabular augment, or other appropriate structure.” (Paragraph [0056-0057]) and wherein a bone screw (500, Paragraph [0087]) is depicted as one of the embodiments in Fig. 20. Figs. 8A-D depict an illustrative irregular (e.g., trabecular, osteo-porous, and/or osteo-derived) unit cell appropriate for additive manufacture in accordance with the invention, wherein Figs. 9A-9L depict renderings of an osteoporous surface in various lattice configurations which can be used on any sort of medical implants (Paragraph [0066]), the lattice configurations comprising a plurality of spaced apart solid struts with lattices positioned between the struts (See examiner annotated Figs. 9I-9J below), the lattices comprising a plurality of nodes and openings disposed in a predetermined orientation, wherein nodes and openings are disposed in rows and columns, and in a parallel orientation (See examiner annotated Fig. 9I above), and wherein Figs. 10A-11B depict images of porous implant sections that have/have not undergone abrasive blasting to create a microtexture which helps osteoblasts adhere to the titanium struts (Paragraph [0064]), and wherein Fig. 20 depicts the bone screw (500, Paragraph [0087]) incorporating both porous regions 502 and non-porous regions 504, wherein the porous regions are disposed at the threads to promote bony purchase, and wherein in one embodiment which depicts a cage (10), the cage consists of a unitary structure that is substantially solid in the middle and graduates to porous at given surfaces which “provides enhanced structural integrity and allows for the porosity to be carefully controlled in a given area, etc.” “or there may be a relatively sharp dividing line between the solid portion and the porous portions, although it is contemplated that they are integrally formed via the additive manufacturing technique.” (Paragraphs [0061, 0068, 0072]).
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It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the bone screw of Armstrong et al. to be manufactured by 3-D printing so that the second zone 34, including the shaft wall and the threads 42 for engaging with cancellous bone, comprises a modified metallic osteoporous/osteoderived/trabecular surface extending from an outermost surface to the inner core and defined by a plurality of struts and lattices positioned therebetween disposed in a layer of parallel rows/columns, as taught by Steinmann et al. in order to promote increased bone purchased between the screw and the cancellous bone after implantation.
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