DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Claim Objections
Claims 226, 228, 232, 235, and 242 are objected to because of the following informalities:
Claim 226 recites “the cancellous bone” in line 4, which appears to be referring to – the piece of bone tissue which is at least partially cancellous –.
Claim 228 recites “particle dissolution rate or particle dimension” in line 6, in which it appears that the word “or” should be replaced with the word “and”, similar to the clause recited in line 3.
Claim 232 recites “the metal ions” in line 1, which appears to be referring to – the at least one type or metal ion –.
Claim 235 recites “particles which are fixed within the roughened or textured bone surface interstices” in lines 2-3, which should be amended to recite – particles which are fixed within the interstices defined by the roughened or textured surface –.
Claim 235 recites “the first water-soluble bioactive material”, which appears to be referring to – the first water-soluble inorganic bioactive material –.
Claim 242 recites “adhesives, and” in line 2, which appears to include a typographical error in which the word “and” should be replaced with the word – or –. Appropriate correction is required.
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 negatived by the manner in which the invention was made.
Claim(s) 226-242 are rejected under pre-AIA 35 U.S.C. 103(a) as obvious over US Patent No. 6,200,347 B1 to Anderson et al. (Anderson) in view of US Patent Application Publication No. 2011/0150963 A1 to Clineff et al. (Clineff).
Regarding at least claim 226
Anderson teaches a composite bone graft for implantation in a patient that is useful for repairing bone defects (abstract). Anderson meets the limitations of a bone allograft (1) comprising: a piece of bone tissue which is at least partially cancellous and defines trabecular interstices (bone portion; 3 is a cancellous part of the bone tissue that makes up the graft, including portions 2 and 4 – cancellous bone is trabecular bone and therefore defines trabecular interstices as claimed); at least a first water-soluble inorganic bioactive material as particles which are fixed within the trabecular interstices of the cancellous bone (col. 7, lines 25-58 discloses that the cancellous bone portion includes one or more therapeutically beneficial substances including, but not limited to, osteoconductive substances such as bioglass, which is a water-soluble inorganic bioactive material and is construed to be fixed within the trabecular interstices of the cancellous bone portion); by a biocompatible binder (col. 12, lines 62-67 through col. 13, lines 1-6 discloses mechanical connectors, for example a pin that may be made of one or more bioabsorbable polymers, and/or chemical connectors, which may be one or more biocompatible adhesives, for interlocking the cortical and cancellous bone portions, thereby at least indirectly fixing the first water-soluble inorganic bioactive material/bioglass within the trabecular interstices of the cancellous bone portion by interlocking it on each side with cortical bone portions).
Anderson also teaches that the cancellous bone portion, which includes a first water-soluble inorganic bioactive material (bioglass), may also include one or more pharmaceutically active agents, such as growth factors that include, but are not limited to, bone growth factors including for example bone morphogenic protein, and transforming growth factor-.beta.; chemotherapeutic agents; anti-inflammatory agents; and antibiotics (col. 7, lines 25-58; at least the chermotherapeutic agents are construed to be antimicrobial because they kill cancer cells and the microbes surrounding them). However, Anderson does not explicitly teach wherein, upon implantation of the bone allograft within a patient in proximity to patient bone tissue, the first water-soluble inorganic bioactive material gradually dissolves releasing at least one of osteoinductive ions and/or non-antibiotic antimicrobial ions as a first elution profile.
Clineff teaches bioactive antibacterial implant materials capable of preventing surgical site infection in a variety of clinical applications including spine and orthopaedic procedures (abstract). Clineff also teaches that the bioactive antibacterial bone graft compositions include bioactive glass particles (paragraph 0001), for the purpose of producing a bioactive antibacterial implant that successfully enhances bone growth and inhibits surgical site infection (paragraph 0006). The implant of Clineff therefore includes antibacterial, bone-bonding and bone inducing properties as desirable by incorporating bioactive glass that reacts as it comes in contact with physiological fluids forming an ion exchange between surrounding fluid and the composite material (paragraphs 0032-0033). Further, Clineff teaches that the bioactive glass comprises at least one alkali metal or another antibacterial agent substituted for the alkali metal (paragraph 0041), which may be silver or another potent antibacterial agent (paragraph 0034, lines 22-25) (the release of silver in ion form, as taught by Clineff, meets the limitation of non-antibiotic antimicrobial ions, particularly since the term “antibacterial” refers to a material that is capable of killing bacteria outright and is therefore antimicrobial, as claimed). Further still, Clineff teaches that the antimicrobial ions are released as the bioactive glass gradually dissolves as a first elution profile (paragraph 0047).
It would have been obvious to one having ordinary skill in the art at the time of the invention to modify the bone graft of Anderson, which promotes the growth of patient bone at an implantation site by promoting osteoinductivity and cellularization, to include at least one type of antimicrobial metal that is releasable in ionic form as biocidal cations, such as silver ions taught Clineff wherein, upon implantation of the bone allograft within a patient in proximity to patient bone tissue, the first water-soluble inorganic bioactive material gradually dissolves releasing at least one of osteoinductive ions and/or non-antibiotic antimicrobial ions as a first elution profile, in order to facilitate bone growth while also preventing surgical site infection, as taught by Clineff.
Regarding at least claim 227
Anderson in view of Clineff teaches the bone allograft according to claim 226. Clineff also teaches wherein the first water-soluble inorganic bioactive material possesses a selected bioactive agent, a bioactive agent concentration (paragraph 0091 discloses a bioactive agent, bioactive glass particles, and a concentration), a particle dissolution rate and particle dimension and, upon particle dissolution, releases osteoinductive ions and/or non-antibiotic antimicrobial ions as the first elution profile over a selected time period, for the purpose of creating an environment that allows bone growth over time (paragraphs 0046-0047 discloses degradation/dissolution rates related to particle dimensions and an elution profile of the ions being released as the particles of the bioactive antibacterial material degrades/dissolves over a selected time period).
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 first water-soluble inorganic bioactive material possesses a selected bioactive agent, a bioactive agent concentration, a particle dissolution rate and particle dimension and, upon particle dissolution, releases osteoinductive ions and/or non-antibiotic antimicrobial ions as the first elution profile over a selected time period, in order to create an environment that allows bone growth over time, as taught by Clineff.
Regarding at least claim 228
Anderson in view of Clineff teaches the bone allograft according to claim 226. Clineff also teaches wherein the first water-soluble inorganic bioactive material includes at least a first bioactive agent, bioactive agent concentration, particle dissolution rate and particle dimension (paragraph 0034 discloses a first bioactive agent that is bioactive glass having a concentration, particle dissolution rate and particle dimension) and the bone allograft further includes at least a second water-soluble inorganic bioactive material that differs from the first water-soluble inorganic bioactive material in at least one of bioactive agent type, bioactive agent concentration, particle dissolution rate or particle dimension (paragraph 0034 discloses a calcium phosphate agent, in addition to bioactive glass, having a concentration, particle dissolution rate or particle dimension) such that dissolving of the second water-soluble inorganic bioactive material upon implantation varies the first elution profile over a selected time period (paragraphs 0054-0055 discloses that the calcium phosphate particles imparts porosity to the composite that enables bone growth to occur concurrent with implant resorption by promoting capillary action of fluids, allowing recruitment of cells for bone formation, and permitting angiogenesis, which results in variation of the first elution profile over a selected time period, as claimed).
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 first water-soluble inorganic bioactive material includes at least a first bioactive agent, bioactive agent concentration, particle dissolution rate and particle and the bone allograft further includes at least a second water-soluble inorganic bioactive material that differs from the first water-soluble inorganic bioactive material in at least one of bioactive agent type, bioactive agent concentration, particle dissolution rate or particle dimension such that dissolving of the second water-soluble inorganic bioactive material upon implantation varies the first elution profile over a selected time period, in order to impart porosity to the composite that enables bone growth to occur concurrent with implant resorption by promoting capillary action of fluids, allowing recruitment of cells for bone formation, and permitting angiogenesis, as taught by Clineff.
Regarding at least claim 229
Anderson in view of Clineff teaches the bone allograft according to claim 226. Anderson also teaches wherein the first water soluble inorganic bioactive material is bioactive glass particles (col. 7, lines 44-53 disclose bioglass, which is a first water soluble inorganic bioactive material that is bioactive glass particles as claimed).
Regarding at least claim 230
Anderson in view of Clineff teaches the bone allograft according to claim 229. Clineff also teaches wherein, upon implantation, dissolution of the bioactive glass particles releases at least osteoinductive ions to enhance bone growth (paragraphs 0054-005 disclose calcium phosphate particles which impart porosity to the composite that enables bone growth to occur concurrent with implant resorption by allowing recruitment of cells for bone formation, among other things, and are therefore osteoinductive).
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 wherein, upon implantation, dissolution of the bioactive glass particles releases at least osteoinductive ions to enhance bone growth, in order to impart porosity to the composite that enables bone growth to occur concurrent with implant resorption by promoting capillary action of fluids, allowing recruitment of cells for bone formation, and permitting angiogenesis, as taught by Clineff.
Regarding at least claim 231
Anderson in view of Clineff teaches the bone allograft according to claim 229. Clineff also teaches wherein, upon implantation, dissolution of the bioactive glass particles releases at least one type of metal ion to provide prophylactic and/or therapeutic concentrations of a non-antibiotic antimicrobial agent (paragraph 0041 discloses at least one alkali metal or another antibacterial agent such as silver which provides therapeutic concentrations of a non-antibiotic antimicrobial agent for the purpose of preventing infection at the surgical site, as disclosed in paragraph 0063).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to specify wherein, upon implantation, dissolution of the bioactive glass particles releases at least one type of metal ion to provide prophylactic and/or therapeutic concentrations of a non-antibiotic antimicrobial agent, in order to prevent infection at the surgical site, as taught by Clineff.
Regarding at least claim 232
Anderson in view of Clineff teaches the bone allograft according to claim 231. Clineff also teaches wherein the metal ions include silver ions, copper ions and/or zinc ions (paragraph 0041 discloses at least one alkali metal or another antibacterial agent such as silver).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to specify wherein the metal ions include silver ions, copper ions and/or zinc ions, which are antibacterial in order to prevent infection at the surgical site, as taught by Clineff.
Regarding at least claim 233
Anderson in view of Clineff teaches the bone allograft according to claim 226. Anderson also teaches wherein the biocompatible binder includes biocompatible polymers and/or adhesives, or biocompatible biodegradable polymers and/or adhesives (col. 12, lines 62-67 through col. 13, lines 1-4 discloses various binder/connectors that may include biocompatible bioabsorbable polymers and/or adhesives).
Regarding at least claim 234
Anderson in view of Clineff teaches the bone allograft according to claim 226. Anderson also teaches wherein the bone tissue further includes at least one of cortical bone tissue or demineralized bone matrix (col. 19, lines 63-66 disclose that the bone tissue of the graft 1 includes two cortical bone portions 2 and 4 and a cancellous bone portion 3; fig. 1).
Regarding at least claim 235
Anderson meets the limitations of a bone allograft (bone graft; 1) having a roughened or textured surface (col. 20, lines 4-8 discloses textured surfaces; 14a and 14b as shown in fig. 1) defining interstices (bone portion; 3 is a cancellous part of the bone tissue that makes up the graft, including portions 2 and 4 – cancellous bone is trabecular bone and therefore defines interstices as claimed) wherein at least a first water-soluble inorganic bioactive material as particles which are fixed within the roughened or textured bone surface interstices (col. 7, lines 25-58 discloses that the cancellous bone portion includes one or more therapeutically beneficial substances including, but not limited to, osteoconductive substances such as bioglass, which is a water-soluble inorganic bioactive material and is construed to be fixed within the interstices of the textured surfaces of the cancellous bone portion) by a biocompatible binder (col. 12, lines 62-67 through col. 13, lines 1-6 discloses mechanical connectors, for example a pin that may be made of one or more bioabsorbable polymers, and/or chemical connectors, which may be one or more biocompatible adhesives, for interlocking the cortical and cancellous bone portions, thereby at least indirectly fixing the first water-soluble inorganic bioactive material/bioglass within the trabecular interstices of the cancellous bone portion by interlocking it on each side with cortical bone portions).
Anderson also teaches that the cancellous bone portion, which includes a first water-soluble inorganic bioactive material (bioglass), may also include one or more pharmaceutically active agents, such as growth factors that include, but are not limited to, bone growth factors including for example bone morphogenic protein, and transforming growth factor-.beta.; chemotherapeutic agents; anti-inflammatory agents; and antibiotics (col. 7, lines 25-58; at least the chermotherapeutic agents are construed to be antimicrobial because they kill cancer cells and the microbes surrounding them). However, Anderson does not explicitly teach such that upon implantation of the bone allograft within a patient in proximity to patient bone tissue, the first water-soluble inorganic bioactive material gradually dissolves releasing at least one of osteoinductive ions and/or non-antibiotic antimicrobial ions as a first elution profile.
Clineff teaches bioactive antibacterial implant materials capable of preventing surgical site infection in a variety of clinical applications including spine and orthopaedic procedures (abstract). Clineff also teaches that the bioactive antibacterial bone graft compositions include bioactive glass particles (paragraph 0001), for the purpose of producing a bioactive antibacterial implant that successfully enhances bone growth and inhibits surgical site infection (paragraph 0006). The implant of Clineff therefore includes antibacterial, bone-bonding and bone inducing properties as desirable by incorporating bioactive glass that reacts as it comes in contact with physiological fluids forming an ion exchange between surrounding fluid and the composite material (paragraphs 0032-0033). Further, Clineff teaches that the bioactive glass comprises at least one alkali metal or another antibacterial agent substituted for the alkali metal (paragraph 0041), which may be silver or another potent antibacterial agent (paragraph 0034, lines 22-25)
(the release of silver in ion form, as taught by Clineff, meets the limitation of non-antibiotic antimicrobial ions, particularly since the term “antibacterial” refers to a material that is capable of killing bacteria outright and is therefore antimicrobial, as claimed). Further still, Clineff teaches that the antimicrobial ions are released as the bioactive glass gradually dissolves as a first elution profile (paragraph 0047).
It would have been obvious to one having ordinary skill in the art at the time of the invention to modify the bone graft of Anderson, which promotes the growth of patient bone at an implantation site by promoting osteoinductivity and cellularization, to include at least one type of antimicrobial metal that is releasable in ionic form as biocidal cations, such as silver ions taught Clineff such that upon implantation of the bone allograft within a patient in proximity to patient bone tissue, the first water-soluble inorganic bioactive material gradually dissolves releasing at least one of osteoinductive ions and/or non-antibiotic antimicrobial ions as a first elution profile, in order to facilitate bone growth while also preventing surgical site infection, as taught by Clineff.
Regarding at least claim 236
Anderson in view of Clineff teaches the bone allograft according to claim 235. Clineff also teaches wherein the first water-soluble inorganic bioactive material possesses a selected bioactive agent, a bioactive agent concentration (paragraph 0091 discloses a bioactive agent, bioactive glass particles, and a concentration), a particle dissolution rate and particle dimension and, upon particle dissolution, releases osteoinductive ions and/or non-antibiotic antimicrobial ions as the first elution profile over a selected time period, for the purpose of creating an environment that allows bone growth over time (paragraphs 0046-0047 discloses degradation/dissolution rates related to particle dimensions and an elution profile of the ions being released as the particles of the bioactive antibacterial material degrades/dissolves over a selected time period).
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 first water-soluble inorganic bioactive material possesses a selected bioactive agent, a bioactive agent concentration, a particle dissolution rate and particle dimension and, upon particle dissolution, releases osteoinductive ions and/or non-antibiotic antimicrobial ions as the first elution profile over a selected time period, in order to create an environment that allows bone growth over time, as taught by Clineff.
Regarding at least claim 237
Anderson in view of Clineff teaches the bone allograft according to claim 235. Clineff also teaches wherein the first water-soluble inorganic bioactive material includes at least a first bioactive agent, bioactive agent concentration, particle dissolution rate and particle dimension (paragraph 0034 discloses a first bioactive agent that is bioactive glass having a concentration, particle dissolution rate and particle dimension) and the bone allograft further includes at least a second water-soluble inorganic bioactive material that differs from the first water-soluble inorganic bioactive material in at least one of bioactive agent type, bioactive agent concentration, particle dissolution rate or particle dimension (paragraph 0034 discloses a calcium phosphate agent, in addition to bioactive glass, having a concentration, particle dissolution rate or particle dimension) such that dissolving of the second water-soluble inorganic bioactive material upon implantation varies the first elution profile over a selected time period (paragraphs 0054-0055 discloses that the calcium phosphate particles imparts porosity to the composite that enables bone growth to occur concurrent with implant resorption by promoting capillary action of fluids, allowing recruitment of cells for bone formation, and permitting angiogenesis, which results in variation of the first elution profile over a selected time period, as claimed).
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 first water-soluble inorganic bioactive material includes at least a first bioactive agent, bioactive agent concentration, particle dissolution rate and particle and the bone allograft further includes at least a second water-soluble inorganic bioactive material that differs from the first water-soluble inorganic bioactive material in at least one of bioactive agent type, bioactive agent concentration, particle dissolution rate or particle dimension such that dissolving of the second water-soluble inorganic bioactive material upon implantation varies the first elution profile over a selected time period, in order to impart porosity to the composite that enables bone growth to occur concurrent with implant resorption by promoting capillary action of fluids, allowing recruitment of cells for bone formation, and permitting angiogenesis, as taught by Clineff.
Regarding at least claim 238
Anderson in view of Clineff teaches the bone allograft according to claim 235. Anderson also teaches wherein the first water soluble inorganic bioactive material is bioactive glass particles (col. 7, lines 44-53 disclose bioglass, which is a first water soluble inorganic bioactive material that is bioactive glass particles as claimed).
Regarding at least claim 239
Anderson in view of Clineff teaches the bone allograft according to claim 238. Clineff also teaches wherein, upon implantation, dissolution of the bioactive glass particles releases at least osteoinductive ions to enhance bone growth (paragraphs 0054-005 disclose calcium phosphate particles which impart porosity to the composite that enables bone growth to occur concurrent with implant resorption by allowing recruitment of cells for bone formation, among other things, and are therefore osteoinductive).
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 wherein, upon implantation, dissolution of the bioactive glass particles releases at least osteoinductive ions to enhance bone growth, in order to impart porosity to the composite that enables bone growth to occur concurrent with implant resorption by promoting capillary action of fluids, allowing recruitment of cells for bone formation, and permitting angiogenesis, as taught by Clineff.
Regarding at least claim 240
Anderson in view of Clineff teaches the bone allograft according to claim 238. Clineff also teaches wherein, upon implantation, dissolution of the bioactive glass particles releases at least one type of metal ion to provide prophylactic and/or therapeutic concentrations of a non-antibiotic antimicrobial agent (paragraph 0041 discloses at least one alkali metal or another antibacterial agent such as silver which provides therapeutic concentrations of a non-antibiotic antimicrobial agent for the purpose of preventing infection at the surgical site, as disclosed in paragraph 0063).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to specify wherein, upon implantation, dissolution of the bioactive glass particles releases at least one type of metal ion to provide prophylactic and/or therapeutic concentrations of a non-antibiotic antimicrobial agent, in order to prevent infection at the surgical site, as taught by Clineff.
Regarding at least claim 241
Anderson in view of Clineff teaches the bone allograft according to claim 240. Clineff also teaches wherein the metal ions include silver ions, copper ions and/or zinc ions (paragraph 0041 discloses at least one alkali metal or another antibacterial agent such as silver).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to specify wherein the metal ions include silver ions, copper ions and/or zinc ions, which are antibacterial in order to prevent infection at the surgical site, as taught by Clineff.
Regarding at least claim 242
Anderson in view of Clineff teaches the bone allograft according to claim 235. Anderson also teaches wherein the biocompatible binder includes biocompatible polymers and/or adhesives, or biocompatible biodegradable polymers and/or adhesives (col. 12, lines 62-67 through col. 13, lines 1-4 discloses various binder/connectors that may include biocompatible bioabsorbable polymers and/or adhesives).
Conclusion
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/M.A.H/Examiner, Art Unit 3774
/SARAH W ALEMAN/Primary Examiner, Art Unit 3774