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 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.
Claims 1-4 and 9-14 are rejected under 35 U.S.C. 103 as being unpatentable over Kalpakci et al. (2019/0021862) “Kalpakci” in view of Khandkar et al. (2005/0177238) “Khandkar” further in view of Shah et al. (2016/0038632) “Shah”.
Regarding claims 1 and 3, Kalpakci discloses an implantable medical device for bone repair following a loss of bone substance (abstract) comprising: a scaffold 10 (Fig. 1) having a three-dimensional structure and comprising at least one polymer of polylactic acid (PLA) (par. 0042 disclose a mesh made of PLA), at least one protein from the Bone Morphogenetic Proteins (BMP) family (par. 0111), wherein the scaffold defines an internal volume comprising a three- dimensional mesh (par. 0042) delimiting pores, the pores being open and interconnected, the largest dimension of each pore being greater than 200 um (par. 0055 discloses a porous mesh having a pore diameter of 2000 microns); except for the scaffold having a minimum porosity of 80%, a film comprising at least one protein from the Bone Morphogenetic Proteins (BMP) family and he film is a film comprising polyelectrolytes and coats the three-dimensional mesh.
However, Khandkar teaches a similar scaffold comprising a PLA scaffold having a porosity of 80% (par. 0012). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the scaffold in Kalpakci to include a porosity of 80%, as taught and suggested by Khandkar, for mimicking natural bone (par. 0012).
Furthermore, Kalpakci in view of Khandkar are silent regarding a film comprising at least one protein from the Bone Morphogenetic Proteins (BMP) family and the film is a film comprising polyelectrolytes and coats the three-dimensional mesh. However, Shah teaches a similar scaffold (par. 0092) comprising a film having at least one protein from the Bone Morphogenetic Proteins (BMP) family and the film is a film comprising polyelectrolytes and coats the scaffold (par. 0166 disclose films of polyelectrolytes deposited on the scaffold and the film comprising BMP). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the mesh scaffold in Kalpakci in view of Khandkar to include a film comprising at least one protein from the Bone Morphogenetic Proteins (BMP) family and the film is a film comprising polyelectrolytes and coats the three-dimensional mesh, as taught and suggested by Shah, for allowing a controlled release of growth factors using fine-tuned adjustment of the degradation rate (par. 0138).
Regarding claim 2, Kalpakci discloses wherein the scaffold is inert (par. 0042 discloses PLA). .
Regarding claim 4, Kalpakci in view of Khandkar and Shah discloses the claimed invention of claim 1; except for wherein the three-dimensional mesh has orientation angles of between -120° and +120°. However, Kalpakci discloses a three-dimensional porous mesh which inherently has a certain orientation angle (par. 0042). It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the the three-dimensional mesh has orientation angles of between -120° and +120°, since these are result effective variables that contribute to the porosity and structural integrity of the scaffold, it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art and modifying the three-dimensional mesh has orientation angles of between -120° and +120° would allow for the mesh to better mimic natural bone whilst allowing sufficient porosity. In re Aller, 105 USPQ 233.
Furthermore, since applicants have not disclosed that these modifications solve any stated problem or are for any particular purpose and it appears that the device would perform equally well with either designs, these modifications are a matter of design choice. Absent a teaching as to criticality that the three-dimensional mesh has orientation angles of between -120° and +120°, this particular arrangement is deemed to have been known by those skilled in the art since the instant specification and evidence of record fail to attribute any significance (novel or unexpected results) to a particular arrangement. In re Kuhle, 526 F.2d 553,555,188 USPQ 7, 9 (CCPA 1975). MPEP 2144.05.
Regarding claim 9, Kalpakci discloses a scaffold which has the structure that is fully capable of performing the intended use of “for repairing a bone volume of between 2 cm3 and 15 cm3”.
Regarding claim 10, Kalpakci discloses wherein the three-dimensional mesh comprises filaments with a diameter of 400 um (par. 0135 discloses a fiber diameter/width of 0.04 cm).
Regarding claim 11, Kalpakci in view of Khandkar and Shah discloses the claimed invention of claim 1; except for wherein the filaments are spaced apart, defining a filament spacing of between 200 um and 2.5 mm. However, Kalpakci in view of Khandkar and Shah discloses a three-dimensional porous mesh having fibers with a porosity of 80% and a pore size of greater than 200 um (see claim 1 above). It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the scaffold to include wherein the filaments are spaced apart, defining a filament spacing of between 200 um and 2.5 mm, since these are result effective variables that contribute to the porosity and structural integrity of the scaffold, it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art and modifying wherein the filaments are spaced apart, defining a filament spacing of between 200 um and 2.5 mm, would allow for the mesh to better mimic natural bone whilst allowing sufficient porosity. In re Aller, 105 USPQ 233.
Furthermore, since applicants have not disclosed that these modifications solve any stated problem or are for any particular purpose and it appears that the device would perform equally well with either designs, these modifications are a matter of design choice. Absent a teaching as to criticality that wherein the filaments are spaced apart, defining a filament spacing of between 200 um and 2.5 mm, this particular arrangement is deemed to have been known by those skilled in the art since the instant specification and evidence of record fail to attribute any significance (novel or unexpected results) to a particular arrangement. In re Kuhle, 526 F.2d 553,555,188 USPQ 7, 9 (CCPA 1975). MPEP 2144.05.
Regarding claims 12-13, Kalpakci discloses the scaffold is manufactured by 3D printing (par. 0043) and a step of sterilising the implantable medical device (par. 0092 discloses steps of keeping the implant sterilizied).
Regarding claim 14, Kalpakci discloses a method for bone repair following a loss of bone substance wherein the implantable medical device according to claim 1 is implanted for repairing a bone volume (abstract and par. 0100); except for a bone volume of between 2 cm3 and 15 cm3. However, Kalpakci discloses a three-dimensional porous mesh for occupying a certain volume of a bone defect (par. 0100). It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the method to include a bone volume of between 2 cm3 and 15 cm3, since these are result effective variables that contribute to the overall regeneration of the bone defect, it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art and modifying a bone volume of between 2 cm3 and 15 cm3, would allow for the mesh to sufficiently occupy the bone defect and better mimic natural bone. In re Aller, 105 USPQ 233.
Furthermore, since applicants have not disclosed that these modifications solve any stated problem or are for any particular purpose and it appears that the device would perform equally well with either designs, these modifications are a matter of design choice. Absent a teaching as to criticality of a bone volume of between 2 cm3 and 15 cm3, this particular arrangement is deemed to have been known by those skilled in the art since the instant specification and evidence of record fail to attribute any significance (novel or unexpected results) to a particular arrangement. In re Kuhle, 526 F.2d 553,555,188 USPQ 7, 9 (CCPA 1975). MPEP 2144.05.
Claims 5-8 are rejected under 35 U.S.C. 103 as being unpatentable over Kalpakci et al. (2019/0021862) “Kalpakci” in view of Khandkar et al. (2005/0177238) “Khandkar” further in view of Shah et al. (2016/0038632) “Shah” further in view of Bouyer et al. “Surface delivery of tunable doses of BMP-2 from an adaptable polymeric scaffold induces volumetric bone regeneration” BIOMATERIALS, ELSEVIER, AMSTERDAM, NL, vol. 104, 29 June 2016 (2016-06-29), pages 168-181, XP029681197, ISSN: 0142-9612, DOI: 10.1016/ J.BIOMATERIALS.2016.06.001 “Bouyer”.
Kalpakci in view of Khandkar and Shah discloses the claimed invention of claim 1; except for comprising a quantity of BMPs in the range 0.01 mg/cm3 to 0.2 mg/cm3; a quantity of BMPs of between 0.017 mg/cm3 and 0.072 mg/cm3; wherein the film is a crosslinked multilayer polyelectrolyte film and wherein the crosslinked film has a concentration of between 30 mg/mL and 70 mg/mL of 1-ethy1-3-(3-dimethylaminopropyl)carbodiimide hydrochloride (EDC). However, Bouyer teaches a similar scaffold having a film (abstract) comprising a quantity of BMPs in the range 0.01 mg/cm3 to 0.2 mg/cm3; a quantity of BMPs of between 0.017 mg/cm3 and 0.072 mg/cm3 (Fig. 2); wherein the film is a crosslinked multilayer polyelectrolyte film and wherein the crosslinked film has a concentration of between 30 mg/mL and 70 mg/mL of 1-ethy1-3-(3-dimethylaminopropyl)carbodiimide hydrochloride (EDC) (page 169 section 2.1).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the mesh scaffold in Kalpakci in view of Khandkar and Shah to include a quantity of BMPs in the range 0.01 mg/cm3 to 0.2 mg/cm3; a quantity of BMPs of between 0.017 mg/cm3 and 0.072 mg/cm3; wherein the film is a crosslinked multilayer polyelectrolyte film and wherein the crosslinked film has a concentration of between 30 mg/mL and 70 mg/mL of 1-ethy1-3-(3-dimethylaminopropyl)carbodiimide hydrochloride (EDC., as taught and suggested by Bouyer, for sufficiently repairing a critical size volumetric bone defect (abstract).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to YASHITA SHARMA whose telephone number is (571)270-5417. The examiner can normally be reached on 8am-5pm M-Th; 8am-4pm Fri (MT).
If attempts to reach the examiner by telephone are unsuccessful, the examiner' s supervisor, Jerrah Edwards, can be reached at 408-918-7557. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/YASHITA SHARMA/
Primary Examiner, Art Unit 3774