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
Claims 54, 92, and 95 are objected to because of the following informalities: Claim 54 recites “the orthopedic joint”, which appears to be referring to – the diarthrodial joint –. Claim 92 recites “and second”, which appears to be missing the word – a – between the words “and” and “second”. Claim 95 recites “at least one of the hard segment “ in line 4, which appears to be referring to – the hard segment –. Claim 95 recites “the urethane dimethacrylate” in line 5, which appears to be referring to – the urethane dimethacrylate monomer –. Claim 95 recites “the first polymeric adhesive” in line 5, which appears to be referring to – the first polymeric layer –. 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 98 is 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 98 depends from 97, which is canceled. For the purpose of further examination, claim 98 is interpreted to depend from claim 92.
Claim 98 recites the limitation "the thermoplastic polymer" in line 4. There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 54, 55, 59, 63, 66-68, 84, 88, 90-93, and 98 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US Patent Application Publication No. 2004/0133278 A1 to Mansmann (Mansmann).
Regarding claim 54
Mansmann teaches a permanent non-resorbable implant that allows surgical replacement of cartilage in articulating joints, using a hydrogel material reinforced by a flexible fibrous matrix (abstract).
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Mansmann meets the limitations of a method for repairing a cartilage lesion on an articulating surface within a diarthrodial joint comprising bone (paragraph 0002), the lesion being at least partially surrounded by exterior cartilage on the articulating surface, a portion of the exterior cartilage providing a region with a native tissue line for articulation (paragraph 0031 discloses that the implants are designed to entirely replace a segment of damaged or diseased cartilage), the method comprising the steps of: (i) preparing a surgical site in the exterior cartilage region by removing at least a portion of the cartilage surrounding the lesion and leaving a hole that extends through the exterior cartilage region and into the bone, wherein the hole in the exterior cartilage has an inside diameter (paragraph 0094 discloses preparing the bone surface by removing cartilage thereby creating a hole having an inside diameter), (ii) providing a biomimetic osteochondral implant (paragraph 0055 discloses hydrogel implants having a combination of enhancements which will render them sufficiently strong and durable to enable effective and successful implantation and use as replacements for injured or diseased cartilage in mammalian joints) comprising a bearing zone (110) and a base construct (150), the bearing zone having an under surface (paragraph 0103 discloses a transition zone with a fully sulfonated polymer on one side of the transition zone and unsulfonated polymer on the other side/under surface; shown by the dotted line 112 in fig. 3) and a compliant surface (surface membrane; 113) with an outer face and a first perimeter having an outside diameter (fig. 2 shows the compliant surface having an outer face and a first perimeter with an outside diameter), the compliant surface configured to change shape upon articulation within the diarthrodial joint so the outer face conforms in shape to an opposing surface of the orthopedic joint (the hydrogel used for the bearing zone 110, and therefore the compliant surface, is flexible as disclosed in paragraph 0055 and fully capable of conforming in shape to an opposing surface); (ii) passing the implant into the hole and towards bone so that the base construct interfaces directly with the bone (paragraph 0117 discloses attaching the bone anchoring layer/base construct 150 directly to bone); and (iii) anchoring the implant to the bone so that the outer face of the compliant surface is offset in height relative to the native tissue line of the exterior cartilage (at least when the implant is intended as a meniscal replacement, the implant is anchored to the bone so that the outer face of the wedge-shaped compliant surface is offset in height relative to the native tissue line of the exterior cartilage as claimed since at least the segment that is largely curved is offset from the perimeter that defines the native tissue line).
Regarding claim 55
Mansmann teaches the method of claim 54, wherein the bearing zone comprises a biphasic polymer (the bearing zone is a hydrogel which is a biphasic polymer; paragraph 0055).
Regarding claim 59
Mansmann teaches the method of claim 54, wherein the biphasic polymer has a water composition gradient between the compliant surface and the under surface (paragraphs 0102-0103 discloses that the surface/compliant layer affected by the sulfonation will likely extend to at least some shallow or moderate depth beneath the actual surface as shown by the dashed line in fig. 3 which is boundary between the chemically altered surface layer 112 and the underlying supporting layer that will not be a completely flat boundary with no thickness and that instead, because of the highly porous nature of the hydrogel, this boundary will be a transition zone with fully sulfonated polymer on one side of the transition zone and unsulfonated polymer on the other side – the examiner interprets the transition zone as a water composition gradient comprising a water composition at the compliant surface, a water composition at the under surface, and a water composition gradient extending therebetween).
Regarding claim 63
Mansmann teaches the method of claim 54, wherein the compliant surface is lubricious (paragraph 0100 discloses that the hydrogel layer is smooth and slippery or “lubricious” and is also provided with a sulfonated surface layer) and the under surface is non-lubricious (paragraph 0103 discloses a fully sulfonated polymer on one side of the transition zone and an unsulfonated polymer on the other side – since the treatment/sulfonation makes the one side of the polymer more lubricious, the polymer on the other side that is unsulfonated is construed to be non-lubricious as claimed).
Regarding claim 66
Mansmann teaches the method of claim 54, wherein the implant is plano-convex or plano-concave (paragraph 0099 discloses that the components are shown in a relatively flat and planar form for simplicity of illustration, but the implant should be designed and manufactured in a way that will allow it to rest, securely, and with minimal stress, on top of the prepared bone surface where it will be anchored, including having a curved surface for replacing a femoral runner; therefore, the implant is construed to be plano-convex or plano-concave, as claimed).
Regarding claim 67
Mansmann teaches the method of claim 54, wherein the base construct comprises a porous metal (paragraph 0111-0112 discloses that the bone anchoring layer is a porous ceramic or a mesh made of compressed strands of titanium steel or other very hard alloy).
Regarding claim 68
Mansmann teaches the method of claim 54, wherein the surgical site is at the distal femur, the proximal tibia, the patella tibiofibular joint, distal tibia, distal fibula, calcaneus, proximal humerus, proximal femur, pelvis glenoid or talus, distal humerus, the proximal ulna, or the proximal radius, distal humerus, the proximal ulna, metatarsophalangeal joint, a tarsometatarsal joint, an intermetatarsal joint, the distal metacarpal, proximal phalanx, distal radius, the distal ulna, the carpals metatarsophalangeal joint, a tarsometatarsal joint, an intermetatarsal joint, the distal metacarpal, the proximal phalanx, or the proximal radius (paragraph 0099 discloses that the components are designed to replace, for example, cartilage on a tibial plateau or a femoral runner).
Regarding claim 84
Mansmann teaches the method of claim 54, wherein the bearing zone is aligned laterally along the first perimeter with the exterior cartilage, such that the bearing zone is in contact with the exterior cartilage (abstract discloses a reinforcing matrix extending out from the peripheral rim of the hydrogel/bearing zone to secure anchoring to soft tissue such that it is aligned laterally along the first perimeter with the exterior cartilage of the joint capsule).
Regarding claim 88
Mansmann teaches the method of claim 54, wherein the compliant surface is offset from the native tissue line in a direction distal to the bone or in a direction proximal to the bone (at least when the implant is intended as a meniscal replacement, the implant is anchored to the bone so that the outer face of the wedge-shaped compliant surface is offset from the native tissue line in a direction distal to or proximal to the bone, as claimed, particularly since the segment that is largely curved is offset from the perimeter that defines the native tissue line).
Regarding claim 90
Mansmann teaches the method of claim 54, wherein the bearing zone comprises a stiffness gradient between the compliant surface and the under surface (paragraphs 0102-0103 discloses a surface/compliant layer affected by the sulfonation, which is more lubricious and therefore construed to have a higher water composition and a lower stiffness, that transitions to an unsulfonated underlying supporting layer, which is non-lubricious and therefore construed to have a lower water composition and a higher stiffness; the transition between the low stiffness compliant surface and the high stiffness undersurface meets the limitation of a stiffness gradient as claimed).
Regarding claim 91
Mansmann teaches the method of claim 90, wherein the stiffness gradient comprises a stiffness at the compliant surface that is less than a stiffness at the under surface (paragraphs 0102-0103 discloses a surface/compliant layer affected by the sulfonation, which is more lubricious and therefore construed to have a higher water composition and a lower stiffness, that transitions to an unsulfonated underlying supporting layer, which is non-lubricious and therefore construed to have a lower water composition and a higher stiffness; the transition between the low stiffness compliant surface and the high stiffness undersurface meets the limitation of a stiffness gradient at the compliant surface that is less than a stiffness at the under surface, as claimed).
Regarding claim 92
Mansmann teaches the method of claim 54, wherein the bearing zone is a first polymeric layer (articulating surface; 112), disposed between the compliant surface and the under surface (fig. 3), and wherein the base construct (150) comprises a porous layer configured to attach directly to the bone (paragraph 0111 discloses attaching the porous bone construct layer directly to the bone) and second polymeric layer (interface layer; 120) attached to the first polymeric layer (112) at a middle interface between the under surface and a shaped surface of the second polymeric layer, such that the second layer is disposed between the middle interface and the porous layer (fig. 3 shows the second layer disposed as claimed).
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Regarding claim 93
Mansmann teaches the method of claim 92, wherein the first polymeric layer (112) has a first stiffness and the second polymeric layer (120) has a second stiffness, and wherein the second stiffness is greater than the first stiffness and/or the porous layer (150) has a third stiffness greater than the second stiffness (paragraph 0105 discloses that the hydrogel material of the first polymeric layer is soft, the second polymeric layer is relatively stiff and hard, and the porous layer is a hard anchoring material – therefore, the second stiffness of the second polymeric layer is greater than the first stiffness of the first polymeric layer, and also the stiffness of the porous anchor layer is greater than the second polymer layer second stiffness, as claimed).
Regarding claim 98
Mansmann teaches the method of claim 97 (interpreted to depend from claim 92), wherein the first polymeric layer is a water- swellable interpenetrating polymer network (IPN) or semi-IPN that comprises a first polymeric network comprising the thermoplastic polymer and a second polymeric network (paragraph 0016 discloses hydrogels that are reinforced with an interpenetrating network of fibers to enhance and strengthen the hydrogel’s mechanical properties).
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) 56 and 60-62 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mansmann.
Regarding claim 56
Mansmann teaches the method of claim 55, wherein the biphasic polymer has a water composition of at least 10% up to 90% (paragraphs 0012 and 0048 disclose hydrogels containing mostly water with only 10% protein or polymeric strands that hold them together and give them strength).
However, Mansmann does not explicitly teach a water composition of at least 10%, at least 20%, or at least 30%.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the water composition of Mansmann from at least 10% up to 90% to at least 10%, at least 20%, or at least 30%, as applicant appears to have placed no criticality on the claimed range (see pp. [0006] indicating the water composition “may” have the claimed percentages) and since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.” In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Regarding claims 60-62
Mansmann teaches the implant of claim 59, wherein the water composition transitions from the compliant surface where it is at its greatest toward the under surface. Mansmann also teaches that the goal of the invention is to provide improved hydrogel devices that can be used effectively for permanently replacing condylar cartilage in joints (paragraph 0050), which includes the intent to mimic the natural tissue being replaced. However, Mansmann does not explicitly teach wherein the water composition gradient has a water composition of less than 5% at the under surface, wherein the water composition at the under surface is less than 1 %, or wherein the water composition gradient has a water composition of at least 40% at the compliant surface.
There is no evidence of record that establishes that specifying that the water composition of the water composition gradient at the under surface is less than 5% or less than 1%, or that the water composition gradient has a water composition at the compliant surface that is at least 40%, would result in a difference in function of the Mansmann device. Further, a person having ordinary skill in the art, being faced with modifying the water composition of Mansmann, would have a reasonable expectation of success in making such a modification and it appears the device would function as intended being given the claimed percentages. Lastly, applicant has not disclosed that the claimed range solves any stated problem, indicating that the biphasic polymer “may” have a water composition within the claimed range, and offering other acceptable ranges (e.g., less than 10%, 5%, or 1% at the undersurface and more than 30%, 40%, or 50% at the compliant surface, specification at para. [0006]) and therefore there appears to be no criticality placed on the range as claimed such that it produces an unexpected result.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the water composition of Mansmann to be less than 5% or 1% at the under surface and at least 40% at the compliant surface as an obvious matter of design choice within the skill of the art, particularly since percentages of the water composition gradient taught by Mansmann decreases from the compliant surface toward the under surface, in order to reflect that of the natural tissue being replaced so that the device can be used effectively for permanently replacing condylar cartilage in joints as intended by Mansmann.
Claim(s) 87 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mansmann, as applied to claim 54, in view of US Patent Application Publication No. 2010/0010114 A1 to Myung et al. (Myung).
Mansmann teaches the method of claim 54, including shaping a hole for placement of the implant when anchored (claim 8 discloses sizing and designing the implant for anchoring to a prepared bone surface). However, Mansmann does not explicitly teach wherein the hole is shaped such that the implant has a press-fit in the hole when anchored.
Myung teaches an IPN or semi-IPN that may have a shape selected to be adapted to fit a meniscus (paragraphs 0026-0027) that may be fixated to bone through any number of means, such as a press-fit (paragraph 0128), in order to partially or completely resurface damaged joints in the body of mammals (paragraph 0128).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to specify that the hole is shaped such that the implant has a press-fit in the hole when anchored, in order to fixate the implant to the bone when partially or completely resurfacing damaged joints in the body of mammals, as taught by Myung.
Claim(s) 95 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mansmann, as applied to claim 92, in view of US Patent Application Publication No. 2013/0103157 A1 to Kourtis et al. (Kourtis).
Mansmann teaches the method of claim 92, including the second polymeric layer (120) and a contemplation of various hydrophilic polyurethane compositions (paragraph 0009). However, Mansmann does not explicitly teach that the second polymeric layer comprises a copolymer of urethane dimethacrylate monomer comprising a hard segment and a soft segment, and methyl methacrylate monomer, and wherein at least one of the hard segment of the urethane dimethacrylate of the first polymeric adhesive is formed from one or more of 1,5-naphthalene diisocyanate (NDI), 2,6 toluene diisocyanate or 2,4 toluene diisocyanate (TDI), 3,3- bitoluene diisocyanate (TODI), cyclohexyl diisocyanate (CHDI), hexamethyl diisocyanate (HDI), isophorone diisocyanate (IPDI), methylene bis(p-phenyl) isocyanate, methylene diphenylisocyanate (MDI), and methylene bis (p-cyclohexyl) isocyanate (HMDI) and the soft segment of the urethane dimethacrylate monomer is formed from one or more of polybutadiene, polyethylene oxide (PEO), hydroxy terminated butadiene, hydroxybutyl-terminated polydimethylsiloxane (PDMS), hydroxyl terminated polyisobutylene, poly(1,6-hexyl- 1,2-ethyl carbonate), polycaprolactone, polycarbonate, polyethylene adipate, polyhexamethylene carbonate glycol, polypropylene oxide (PPO), polytetramethylene adipate, poly(dimethylsiloxane), and poly(tetramethylene oxide) (PTMO).
Kourtis teaches a polymeric adhesive for anchoring compliant materials to another surface (title) such as a composition of matter that includes a urethane dimethacrylate-methyl methacrylate copolymer with a plurality of first polymer regions and a plurality of second polymer regions (abstract). Kourtis also teaches that the chemical composition of urethane dimethacrylate (UDMA) may be tailored to match the polyurethane structure of the anchoring surface of an IPN or semi-IPN containing material or device, and that the anchoring surface comprised of ElasthaneTM 75D is an MDI (4,4-Methylenebis(phenyl isocyanate)) based polyurethane that contains PTMO (poly(tetramethyl)glycol) of molecular weight 650 Da as the soft segment and BD (2-Butene-1,4-diol) as the chain extender. Further, in some embodiments, the UDMA in the polymeric adhesive closely matches the structure of ElasthaneTM 75D by employing the same hard and soft segments (FIG. 9) and to facilitate crosslinking, the UDMA is terminated with HEMA (2-Hydroxyethyl methacrylate) (FIG. 9). Further still, Kourtis teaches that this similarity between the polymeric adhesive and ElasthaneTM 75D is key to the adhesive capability of polymeric adhesive as we hypothesize that hydrogen bonds between the hard segments of the ElasthaneTM 75D and the polymeric adhesive are formed, developing a strong adhesive force (paragraph 0151).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to specify that the second polymeric layer of Mansmann comprises a copolymer of urethane dimethacrylate monomer comprising a hard segment and a soft segment, and methyl methacrylate monomer, and wherein at least one of the hard segment of the urethane dimethacrylate of the first polymeric adhesive is formed from one or more of 1,5-naphthalene diisocyanate (NDI), 2,6 toluene diisocyanate or 2,4 toluene diisocyanate (TDI), 3,3- bitoluene diisocyanate (TODI), cyclohexyl diisocyanate (CHDI), hexamethyl diisocyanate (HDI), isophorone diisocyanate (IPDI), methylene bis(p-phenyl) isocyanate, methylene diphenylisocyanate (MDI), and methylene bis (p-cyclohexyl) isocyanate (HMDI) and the soft segment of the urethane dimethacrylate monomer is formed from one or more of polybutadiene, polyethylene oxide (PEO), hydroxy terminated butadiene, hydroxybutyl-terminated polydimethylsiloxane (PDMS), hydroxyl terminated polyisobutylene, poly(1,6-hexyl- 1,2-ethyl carbonate), polycaprolactone, polycarbonate, polyethylene adipate, polyhexamethylene carbonate glycol, polypropylene oxide (PPO), polytetramethylene adipate, poly(dimethylsiloxane), and poly(tetramethylene oxide) (PTMO), in order to form a polymeric adhesive with a strong adhesive force, as taught by Kourtis.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MELISSA A HOBAN whose telephone number is (571)270-5785. The examiner can normally be reached Monday-Friday 8:00AM-5:00PM.
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/M.A.H/Examiner, Art Unit 3774
/MELANIE R TYSON/Supervisory Patent Examiner, Art Unit 3774
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