Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-4, 11-18 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Lynn (2010/0248368A1) in view of Lu (2006/0159663A1).
In regard to claim 1, Lynn teaches a biocompatible [0207] and bioresorbable [0019-0120] implant having a physically and mechanically stable bi-phasic structure for the repair of bone and cartilage (mineralized and unmineralized layers therefore biphasic; fig 1-3) [0082: two layer], comprising
a cell conductive zone (unmineralized layer [0120; 0141; 0130]) that contains a first matrix including first biopolymeric fibers and glycosaminoglycans [0130: unmineralized type II collagen-glycosaminoglycan scaffold; 0141],
and an osteoconductive zone [0155: mineralized collagen; 0120; 0041-0042; 0120: bottom region comprises a mineralized scaffold] that contains a second matrix including second biopolymeric fibers and a calcium-containing silicate [0076: calcium source may be calcium silicate],
the cell conductive zone is free of calcium-containing silicate [0120; 0141; 0130: unmineralized],
the first biopolymeric fibers extend into the osteoconductive zone and overlap with the second biopolymeric fibers [0159; 0155] such that the cell conductive zone and the osteoconductive zone are physically and mechanically integrated [0161: freeze drying forms an interpenetrating collagen fiber network; interpenetrated is interpreted to mean the zones are both physically and mechanically integrated by the collagen fibers], the cell conductive zone overlaps with and is in direct contact with the osteoconductive zone. [0161]
However, Lynn remains silent to the calcium containing silicate being a glass.
Lu teaches a calcium silicate glass in a bone implant. [0047: 45S5 Bioglass; 0060]
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to use the calcium silicate glass of Lu in place of calcium silicate because they are both calcium containing silicates and the specific 45S5 Bioglass is used to facilitate bone regeneration [0062].
In regard to claim 2, Lynn meets the claim limitations as discussed in the rejection of claim 1, and further teaches the first biopolymeric fibers are formed of a fibrillar collagen. (collagen is fibrillary [0155; 0037])
In regard to claim 3, Lynn meets the claim limitations as discussed in the rejection of claim 2, wherein the fibrillar collagen is type I collagen, type II collagen, or type III collagen. [0159: type I collagen]
In regard to claim 4, Lynn meets the claim limitations as discussed in the rejection of claim 1, and further teaches the osteoconductive zone further contains glycosaminoglycans. [0019; 0025: first and second components contain glycosaminoglycan; 0148: mineralized type I collagen glycosaminoglycan]
In regard to claims 11-12, Lynn meets the claim limitations as discussed in the rejection of claim 1, and further teaches a bioactive molecule wherein the bioactive molecule is a growth factor [0269: growth factor], a cell adhesive molecule, a cytokine, a glycoprotein, a proteoglycan, an antibiotic, or a polysaccharide [0077: glycosaminoglycans contain polysaccharides].
In regard to claims 13-14, Lynn meets the claim limitations as discussed in the rejection of claim 1, and further teaches cells; wherein the cells are osteoblasts, chondrocytes, stem cells, or bone marrow cells. [0411: since the scaffold recruits bone marrow stem cells, the stem cells will be part of the scaffold after implantation]
In regard to claim 15, Lynn meets the claim limitations as discussed in the rejection of claim 1, but does not teach the calcium-containing silicate is 45S5 Bioglass.
As discussed in the rejection of claim 1, Lu teaches a calcium silicate glass in a bone implant, wherein the calcium-containing silicate based glass is 45S5 Bioglass. [0047: 45S5 Bioglass; 0060]
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to use the calcium silicate glass of Lu in place of calcium silicate because they are both calcium containing silicates and the specific 45S5 Bioglass is used to facilitate bone regeneration [0062].
In regard to claim 16, Lynn teaches a biocompatible [0207] and bioresorbable [0019-0120] implant for the repair of bone and cartilage (mineralized and unmineralized layers therefore biphasic; fig 1-2) [0082],
comprising a matrix that contains biopolymeric fibers and glycosaminoglycans [0155: collagen-glycosaminoglycan; collagen naturally is made of fibers],
the matrix having a cell conductive zone [0155; 0159; zone free of mineral particles], and an osteoconductive zone [0155: mineralized collagen; 0120; 0041-0042],
wherein the osteoconductive zone includes a calcium-containing silicate, [0076: calcium source may be calcium silicate],
the cell conductive zone is free of calcium-containing silicate, [0155; 0159; free of mineral particles],
the biopolymeric fibers extend from the cell conductive zone into the osteoconductive zone, [0155; 0161]
and the cell conductive zone is in direct contact with the osteoconductive zone. [0155; 0161]
However, Lynn remains silent to the calcium containing silicate being a glass.
Lu teaches a calcium silicate glass in a bone implant. [0047: 45S5 Bioglass; 0060]
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to use the calcium silicate glass of Lu in place of calcium silicate because they are both calcium containing silicates and the specific 45S5 Bioglass is used to facilitate bone regeneration [0062].
In regard to claim 17, Lynn meets the claim limitations as discussed in the rejection of claim 16, and further teaches the biopolymeric fibers include a fibrillar collagen (collagen is fibrillary [0155; 0037]) and the calcium-containing silicate is present at 60% to 90% by weight of the implant. [0284: 20-200% by weight of calcium-containing mineral particles; 0076: calcium source may be calcium silicate].
However, as discussed in the rejection of claim 16, Lynn does not teach the calcium containing silicate is a calcium containing silicate glass.
Lu teaches a calcium silicate glass in a bone implant As discussed in the rejection of claim 16. [0047: 45S5 Bioglass; 0060]
In regard to claim 18, Lynn meets the claim limitations as discussed in the rejection of claim 17, and further teaches the fibrillar collagen is type I collagen. [0155: type I collagen suspension; collagen is naturally made of fibers]
However, Lynn does not teach the calcium containing silicate is glass based.
As discussed in the rejection of claim 16, Lu teaches calcium-containing silicate is 4555 bioglass. [0047]
Claim 5 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Lynn (20100248368A1) in view of Lu (2006/0159663A1) and further in view of Ding (Journal of Bone and Joint Surgery).
In regard to claim 5, Lynn meets the claim limitations as discussed in the rejection of claim 1, but did not teach the density and compressive modulus.
Ding teaches the first matrix has a density of 0.03 g/cm3 to 0.8 g/cm3 and a compressive modulus of 0.05 N/cm2 to 10 N/cm2.
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to use the density values of Ding in Lynn’s invention in order to match the properties of natural human cartilage since the first matrix of Lynn’s invention is designed as a cartilage scaffold.
Claims 6-9 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Lynn (20100248368A1) in view of Lu (2006/0159663A1) and in view of Ding (Journal of Bone and Joint Surgery) and further in view of Trafton (New tissue regrows cartilage and bone).
In regard to claim 6, Lynn meets the claim limitations as discussed in the rejection of claim 5, but does not state the shape of the implant.
Trafton is an article about the same implant (same inventors, same composition) the shape of the implant is a circular cylinder. (photo, paragraph 2, states the implant is placed in a hole, therefore making it obvious to be circular to match the hole).
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to use the circular cylinder shape of Trafton for the implant of Lynn to meet the needs of the bone and cartilage being replaced, particularly since both references appear to refer to the same implant, and further in order for the implant to fill a cylindrical defect.
In regard to claim 7, Lynn meets the claim limitations as discussed in the rejection of claim 6, but does not teach the implant size as claimed.
It has been held that a mere change in size of the working parts of an invention, yielding a predictable result, requires no more than routine skill in the art. Accordingly, it would have been obvious to one of ordinary skill in the art at the time the invention was filed to have the implant have a length of 0.3 cm to 2 cm and a diameter of 0.2 cm to 3 cm. Absent a teaching of criticality (new or unexpected results), the length of 0.3cm to 2cm and diameter of 0.2 to 3cm is deemed to have been known by those skilled in the art at the time the invention was filed. MPEP 2144.04IVA
In regard to claim 8, Lynn meets the claim limitations as discussed in the rejection of claim 7, and further teaches a content of the calcium-containing silicate is from 30% to 95% by weight of the implant. [0284: 20-200% by weight of calcium-containing mineral particles; 0076: calcium source may be calcium silicate].
As discussed in the rejection of claim 1, Lynn does not teach the calcium containing silicate is a calcium-silicate containing glass.
As discussed in the rejection of claim 1, Lu teaches the calcium containing silicate is a calcium-silicate containing glass. [0047: 45S5 Bioglass; 0060]
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to use the calcium silicate glass of Lu in place of calcium silicate because they are both calcium containing silicates and the specific 45S5 Bioglass is used to facilitate bone regeneration [0062].
In regard to claim 9, Lynn meets the claim limitations as discussed in the rejection of claim 8, and further teaches a length of the cell conductive zone (mineral particle free zone) is 10% to 60% of the length of the implant. (see figure 3, approximately 40%)
Claim 10 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Lynn (20100248368A1) in view of Lu (2006/0159663A1) and further in view of Ding (Journal of Bone and Joint Surgery) and in view of Trafton (New tissue regrows cartilage and bone) and further in view of Walter (6203573B1).
In regard to claim 10, Lynn meets the claim limitations as discussed in the rejection of claim 9, and further teaches the content of the calcium-containing silicate is from 60% to 90% by weight of the implant [0284: 20-200% by weight of calcium-containing mineral particles; 0076: calcium source may be calcium silicate]; the length of the cell conductive zone is 15% to 40% of the length of the implant (figure 3, approximately 40%).
However, Lynn does not teach the implant length, diameter, that the calcium-containing silicate is glass, the density and compressive modulus.
Ding teaches collagen is naturally found in humans at a density of 0.03 g/cm^3 to 0.8 g/cm^3 (figure 4) which overlaps with the desired range of 0.05 g/cm3 to 0.5 g/cm3.
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to use the density values of Ding in Lynn’s invention in order to match the properties of natural human cartilage since the first matrix of Lynn’s invention is designed as a cartilage scaffold. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. MPEP 2144.05I
Walter teaches that cartilage should have a compressive modulus of 0.1 N/cm2 to 5 N/cm2 (Young’s modulus of less than 1Mpa which converts to less than 100N/cm^2; Col 2, lines 9-10).
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to use the compressive modulus of Walter in the scaffold of Lynn in order to match the properties of natural human cartilage since the first matrix of Lynn’s invention is designed as a cartilage scaffold. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. MPEP 2144.05I
It has been held that a mere change in size of the working parts of an invention, yielding a predictable result, requires no more than routine skill in the art. Accordingly, it would have been obvious to one of ordinary skill in the art at the time the invention was filed to have the implant have a length of 0.5 to 1.25cm and a diameter of 0.5 cm to 1.5 cm. Absent a teaching of criticality (new or unexpected results), the length of 0.5 to 1.25cm and diameter of 0.5 cm to 1.5 cm is deemed to have been known by those skilled in the art at the time the invention was filed. MPEP 2144.04IVA
As discussed in the rejection of claim 1, Lu teaches the calcium-containing silicate is glass [0047, 0060]
Claim 19 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Lynn (20100248368A1) in view of Lu (2006/0159663A1) and further in view of Trafton (New tissue regrows cartilage and bone).
In regard to claim 19, Lynn meets the claim limitations as discussed in the rejection of claim 18 and further teaches the cell conductive zone has a length equal to 15% to 40% of the implant length. (mineral particle free zone is approximately 40% the length of the implant as shown in figure 3).
However, Lynn does not teach the implant is cylindrical or the size of the implant.
It has been held that a mere change in size of the working parts of an invention, yielding a predictable result, requires no more than routine skill in the art. Accordingly, it would have been obvious to one of ordinary skill in the art at the time the invention was filed to have the implant have a length of 0.5 to 1.25cm and a diameter of 0.5 cm to 1.5 cm. Absent a teaching of criticality (new or unexpected results), the length of 0.3cm to 1.25 to 1.5cm and diameter of 0.5 to 1.5cm is deemed to have been known by those skilled in the art at the time the invention was filed. MPEP 2144.04IVA
Trafton is an article about the same implant (same inventors, same composition) the shape of the implant is a circular cylinder. (photo, paragraph 2, states the implant is placed in a hole, therefore making it obvious to be circular to match the hole).
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to use the circular cylinder shape of Trafton for the implant of Lynn to meet the needs of the bone and cartilage being replaced, particularly since both references appear to refer to the same implant, and further in order for the implant to fill a cylindrical defect.
Claim 20 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Lynn (20100248368A1) in view of Lu (2006/0159663A1) and further in view of Walter (6203573B1) in view of Trafton (New tissue regrows cartilage and bone) and further in view of Ding (Journal of Bone and Joint Surgery).
In regard to claim 20, Lynn meets the claim limitations as discussed in the rejection of claim 19.
However, Lynn does not teach the compressive modulus as claimed.
Ding teaches collagen is naturally found in humans at a density of 0.03 g/cm^3 to 0.8 g/cm^3 (figure 4) which overlaps with the desired range of 0.05 g/cm3 to 0.5 g/cm3.
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to use the density values of Ding in Lynn’s invention in order to match the properties of natural human cartilage since the first matrix of Lynn’s invention is designed as a cartilage scaffold. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. MPEP 2144.05I
Walter teaches that cartilage should have a compressive modulus of 0.1 N/cm2 to 5 N/cm2 (Young’s modulus of less than 1Mpa which converts to less than 100N/cm^2; Col 2, lines 9-10).
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to use the compressive modulus of Walter in the scaffold of Lynn in order to match the properties of natural human cartilage since the first matrix of Lynn’s invention is designed as a cartilage scaffold. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. MPEP 2144.05I
Conclusion
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/CHRISTIE BAHENA/Primary Examiner, Art Unit 3774
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