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 .
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-15, in the reply filed on December 1, 2025 is acknowledged. Claims 16-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 2, 9, 12, 14, and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Gray et al. (US 2016/0177026) in view of either one of Cordero et al. (US 2022/0072763) or Skalla et al. (US 2020/0095374) and in view of Yan et al. (Synthesis and RGD peptide modification of poly{(lactic acid)-co-[glycolic acid)-alt-(L-lysine)]}; 2008).
Regarding claim 1, Gray et al. teach a method of producing a bioactive polymer filament/fibers (Abstract; paragraphs [0037], [0075], [0082]-[0089] and [0091]-[0109]) comprising providing a base polymer (paragraphs [0011]-[0015], [0037]-[0040], [0074], and [0075]) and a bioactive material (paragraphs [0082], [0083], [0089], and [0091]-[0109]); mixing the base polymer with the bioactive materials to obtain a mixture (paragraphs [0075], [0082], [0083], [0087], [0089], and [0109]); and extruding the mixture at an extrusion temperature profile that is based on a predetermined melt/softening temperature and a predetermined onset degradation temperature of the bioactive polymer (paragraphs [0042]-[0044], [0059], [0061], [0064], [0074], [0089[; Table 1; Table 6; Table 7; teaching and suggesting that the material is melted at a known/predetermined/established melt temperature with a known/predetermined/established onset of degradation temperature in view); and performing a post-extrusion thermal analysis on the extruded bioactive polymer filament to assess onset of degradation of the bioactive polymer in the filament (paragraphs [0042], [0044], [0061] , [0064], [0074], [0089]; Table 1; Table 6; Table 7; characteristics such as thermal stability, inherent viscosity, and temperature degradation of the material are evaluated after extrusion to ensure the desired improvement is realized).
Gray et al. do not teach the mixing of the materials includes providing the base polymer as a powder for mixing with the bioactive material. However, each of Cordero et al. (paragraphs [0069], [0080], [0088], [0104]) and Skalla et al. (paragraph [0145]) disclose analogous methods wherein mixing is performed by providing an analogous base polymer as a powder.
Therefore it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have combined the teaching of Gray et al. and either one of Cordero et al. and Skalla et al. and to have provided the base polymer of as a powder for mixing with the bioactive materials prior to extrusion in the method of Gray et al., as suggested by either one of Cordero et al. or Skalla et al., for the purpose, as suggested by Cordero et al., of facilitating the formation of a homogeneous mixture and the extrusion of a fiber/filament having desired dimensions, or for the purpose, as suggested by Skalla et al. and Cordero et al., of providing an analogous base material in an art recognized suitable form for extruding into a filament/fiber.
Additionally, Gray et al. do not explicitly teach the bioactive material is provided in the form of a copolymer. However, Yan et al. teach an analogous method and material wherein the bioactive material is provided as a copolymer (Abstract; Introduction; pages 7-10).
Therefore it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have combined the teaching of Gray et al. and Yan et al. and to have provided the bioactive material as a bioactive copolymer in the method of Gray et al., as suggested by Yan et al., for the purpose, as suggested by Yan et al. of improving cell affinity and the use of the material in biodegradable applications.
As to claim 2, the bioactive copolymer set forth in Yan et al. is acellular (Abstract; Introduction; pages 7-10).
As to claims 9 and 12, Gray et al. teach utilizing TGA and DSC for analysis (paragraphs [0017], [0042]-[0044], [0061], [0086]). Performing the analysis with these techniques, both before and after extrusion, are reasonably suggested and rendered prima facie obvious in order to quantify the intended improvements/maintenance of properties (Abstract).
As to claim 14, Gray et al. teach and suggest adding the bioactive material in amounts as desired to provide the desired therapeutic effect (paragraph [0082], [0083], [0089], [0091]-[0109]). As such, determining the amount of the bioactive material would be readily determined as a routine expedient and a result effective variable
As to claim 15, Gray et al. teach base polymers as claimed (paragraphs [0011]-[0014], [0037]-[0040] and [0075])
Claim 7 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Gray et al. (US 2016/0177026) in view of either one of Cordero et al. (US 2022/0072763) or Skalla et al. (US 2020/0095374) and in view of Yan et al. (Synthesis and RGD peptide modification of poly{(lactic acid)-co-[glycolic acid)-alt-(L-lysine)]}; 2008), as applied to claims 1, 2, 9, 12, 14 and 15 above, and further in view of Maziers (US 2016/0009058).
As to claims 7 and 8, the combination teaches the method set forth above. Gray et al. do not teach forming a powder as claimed and having a particle size as claimed. However, Maziers teaches an analogous method of producing PLA powders wherein the powder is formed by cryogenic grinding/milling to produce a powder of a desired particle size within the claimed range (paragraph [0126] and [0201]).
Therefore it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have combined the teaching of Gray et al. and Maziers and to have cryogenically milled the material of Gray et al. to a particle size within the claimed range, as suggested by Maziers, for the purpose, as suggested by Maziers of producing a particle that avoids yellowing.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Gray et al. (US 2016/0177026) in view of either one of Cordero et al. (US 2022/0072763) or Skalla et al. (US 2020/0095374) and in view of Yan et al. (Synthesis and RGD peptide modification of poly{(lactic acid)-co-[glycolic acid)-alt-(L-lysine)]}; 2008), as applied to claims 1, 2, 9, 12, 14 and 15 above, and further in view of Barrett et al. (US 2019/0388336).
As to claim 10, the combination teaches the method set forth above. Gray et al. teach extrusion, which reasonably implies and suggests one or more rotating screws, but do not explicitly teach a screw. Barrett et al. teach an analogous method wherein extrusion is performed with screws as claimed (paragraphs [0034] and [0038]; Abstract).
Therefore it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have combined the teaching of Gray et al. and Barrett et al. and to have utilized one or more rotating screws in the method of Gray et al., as suggested by Barrett et al., for the purpose, as suggested by the references of effectively mixing, melting, transporting, and processing the material in the extruder.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Gray et al. (US 2016/0177026) in view of either one of Cordero et al. (US 2022/0072763) or Skalla et al. (US 2020/0095374) and in view of Yan et al. (Synthesis and RGD peptide modification of poly{(lactic acid)-co-[glycolic acid)-alt-(L-lysine)]}; 2008), as applied to claims 1, 2, 9, 12, 14 and 15 above, and further in view of any one of Barrett et al. (US 2019/0388336), Taylor et al. (US 2022/0176619), or Davis et al. (US 8,128,954).
As to claim 11, the combination teaches the method set forth above. Gray et al. teach do not explicitly teach the diameter of the filament/fiber. However, each of Barrett et al. (paragraphs [0034] and [0038]; Abstract)), Taylor et al. (paragraphs [0010], [0011], [0321]) and Davis et al. (col. 11, line 62-col. 12, line 10; claim 1; it is noted that Davis et al. is incorporated by reference into the disclosure of Gray et al. at paragraphs [0083] and [0090]), teach an analogous method wherein the diameter of the filament/fiber is within the claimed range.
Therefore it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have combined the teaching of Gray et al. and any one of the secondary references and to have produced a filament/fiber having a diameter as claimed in the method of Gray et al., as suggested by any one of the secondary references, for the purpose, as suggested by the references, of providing the filament/fiber with a diameter suitable for subsequent use in desired applications.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Gray et al. (US 2016/0177026) in view of either one of Cordero et al. (US 2022/0072763) or Skalla et al. (US 2020/0095374) and in view of Yan et al. (Synthesis and RGD peptide modification of poly{(lactic acid)-co-[glycolic acid)-alt-(L-lysine)]}; 2008), as applied to claims 1, 2, 9, 12, 14 and 15 above, and further in view of Li et al. (US 2008/0319114) and Sherwood et al. (US 6,454,811).
As to claim 13, the combination teaches the method set forth above. Gray et al. do not teach vacuum drying the materials as claimed. However, each of Li et al. (Abstract; paragraph [0011]) and Sherwood et a. (col. 19, lines 5-15) teach analogous methods wherein the corresponding base powders and bioactive materials are vacuum dried prior to further use.
Therefore it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have combined the teaching of Gray et al. with Li et al. and Sherwood et al. and to have vacuum dried the base polymers and bioactive materials of Gray et al., as suggested by Li et al. and Sherwood et al., for the purpose, as suggested by the references of placing the materials in condition that is ready for use after synthesis (e.g. removal of moisture, unreacted materials, solvents).
Claims 1-6, 9, 12, 14, and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Gray et al. (US 2016/0177026) in view of either one of Cordero et al. (US 2022/0072763) or Skalla et al. (US 2020/0095374) and in view of either one of Chickering et al. (WO 2018/106738) or Blum et al. (US 2018/0042843).
Regarding claims 1-6, Gray et al. teach a method of producing a bioactive polymer filament/fibers (Abstract; paragraphs [0037], [0075], [0082]-[0089] and [0091]-[0109]) comprising providing a base polymer (paragraphs [0011]-[0015], [0037]-[0040], [0074], and [0075]) and a bioactive material (paragraphs [0082], [0083], [0089], and [0091]-[0109]); mixing the base polymer with the bioactive materials to obtain a mixture (paragraphs [0075], [0082], [0083], [0087], [0089], and [0109]); and extruding the mixture at an extrusion temperature profile that is based on a predetermined melt/softening temperature and a predetermined onset degradation temperature of the bioactive polymer (paragraphs [0042]-[0044], [0059], [0061], [0064], [0074], [0089[; Table 1; Table 6; Table 7; teaching and suggesting that the material is melted at a known/predetermined/established melt temperature with a known/predetermined/established onset of degradation temperature in view); and performing a post-extrusion thermal analysis on the extruded bioactive polymer filament to assess onset of degradation of the bioactive polymer in the filament (paragraphs [0042], [0044], [0061] , [0064], [0074], [0089]; Table 1; Table 6; Table 7; characteristics such as thermal stability, inherent viscosity, and temperature degradation of the material are evaluated after extrusion to ensure the desired improvement is realized).
Gray et al. do not teach the mixing of the materials includes providing the base polymer as a powder for mixing with the bioactive material. However, each of Cordero et al. (paragraphs [0069], [0080], [0088], [0104]) and Skalla et al. (paragraph [0145]) disclose analogous methods wherein mixing is performed by providing an analogous base polymer as a powder.
Therefore it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have combined the teaching of Gray et al. and either one of Cordero et al. and Skalla et al. and to have provided the base polymer of as a powder for mixing with the bioactive materials prior to extrusion in the method of Gray et al., as suggested by either one of Cordero et al. or Skalla et al., for the purpose, as suggested by Cordero et al., of facilitating the formation of a homogeneous mixture and the extrusion of a fiber/filament having desired dimensions, or for the purpose, as suggested by Skalla et al. and Cordero et al., of providing an analogous base material in an art recognized suitable form for extruding into a filament/fiber.
Additionally, Gray et al. do not explicitly teach the bioactive material is provided in the form of a copolymer as set forth in claims 1-6. However, each of Chickering et al. (Examples; claims 16-19 and 23-26) and Blum et al. (Abstract; paragraphs [0005], [0011], [0101], [0124], [0185], [0242], [0250], Figures 1, 8A, 13-17, 23, 27 and 32) teach and suggest analogous methods and materials wherein the bioactive material is provided as an acellular bioactive copolymer that is achieved by a ring-opening metathesis polymerization and comprises a poly(norbornene) backbone as claimed.
Therefore it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have combined the teaching of Gray et al. and either one of Chickering et al. or Blum et al. and to have provided the bioactive material as an acellular bioactive copolymer formed by a ring-opening metathesis polymerization and comprising a poly(norbornene) backbone as claimed in the method of Gray et al., as suggested by either one of Chickering et al. or Blum et al., for the purpose, as suggested by the references of providing a desired degree and type of bioactivity to the fiber/filament of Gray et al. In the combination, the bioactive synthetic copolymers formed by the secondary references teach and render prima facie obvious the claimed bioactive copolymer materials.
As to claims 9 and 12, Gray et al. teach utilizing TGA and DSC for analysis (paragraphs [0017], [0042]-[0044], [0061], [0086]). Performing the analysis with these techniques, both before and after extrusion, are reasonably suggested and rendered prima facie obvious in order to quantify the intended improvements/maintenance of properties (Abstract).
As to claim 14, Gray et al. teach and suggest adding the bioactive material in amounts as desired to provide the desired therapeutic effect (paragraph [0082], [0083], [0089], [0091]-[0109]). As such, determining the amount of the bioactive material would be readily determined as a routine expedient and a result effective variable
As to claim 15, Gray et al. teach base polymers as claimed (paragraphs [0011]-[0014], [0037]-[0040] and [0075])
Claim 7 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Gray et al. (US 2016/0177026) in view of either one of Cordero et al. (US 2022/0072763) or Skalla et al. (US 2020/0095374) and in view of either one of Chickering et al. (WO 2018/106738) or Blum et al. (US 2018/0042843), as applied to claims 1-6, 9, 12, 14 and 15 above, and further in view of Maziers (US 2016/0009058).
As to claims 7 and 8, the combination teaches the method set forth above. Gray et al. do not teach forming a powder as claimed and having a particle size as claimed. However, Maziers teaches an analogous method of producing PLA powders wherein the powder is formed by cryogenic grinding/milling to produce a powder of a desired particle size within the claimed range (paragraph [0126] and [0201]).
Therefore it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have combined the teaching of Gray et al. and Maziers and to have cryogenically milled the material of Gray et al. to a particle size within the claimed range, as suggested by Maziers, for the purpose, as suggested by Maziers of producing a particle that avoids yellowing.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Gray et al. (US 2016/0177026) in view of either one of Cordero et al. (US 2022/0072763) or Skalla et al. (US 2020/0095374) and in view of either one of Chickering et al. (WO 2018/106738) or Blum et al. (US 2018/0042843), as applied to claims 1-6, 9, 12, 14 and 15 above, and further in view of Barrett et al. (US 2019/0388336).
As to claim 10, the combination teaches the method set forth above. Gray et al. teach extrusion, which reasonably implies and suggests one or more rotating screws, but do not explicitly teach a screw. Barrett et al. teach an analogous method wherein extrusion is performed with screws as claimed (paragraphs [0034] and [0038]; Abstract).
Therefore it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have combined the teaching of Gray et al. and Barrett et al. and to have utilized one or more rotating screws in the method of Gray et al., as suggested by Barrett et al., for the purpose, as suggested by the references of effectively mixing, melting, transporting, and processing the material in the extruder.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Gray et al. (US 2016/0177026) in view of either one of Cordero et al. (US 2022/0072763) or Skalla et al. (US 2020/0095374) and in view of either one of Chickering et al. (WO 2018/106738) or Blum et al. (US 2018/0042843), as applied to claims 1-6, 9, 12, 14 and 15 above, and further in view of any one of Barrett et al. (US 2019/0388336), Taylor et al. (US 2022/0176619), or Davis et al. (US 8,128,954).
As to claim 11, the combination teaches the method set forth above. Gray et al. teach do not explicitly teach the diameter of the filament/fiber. However, each of Barrett et al. (paragraphs [0034] and [0038]; Abstract)), Taylor et al. (paragraphs [0010], [0011], [0321]) and Davis et al. (col. 11, line 62-col. 12, line 10; claim 1; it is noted that Davis et al. is incorporated by reference into the disclosure of Gray et al. at paragraphs [0083] and [0090]), teach an analogous method wherein the diameter of the filament/fiber is within the claimed range.
Therefore it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have combined the teaching of Gray et al. and any one of the secondary references and to have produced a filament/fiber having a diameter as claimed in the method of Gray et al., as suggested by any one of the secondary references, for the purpose, as suggested by the references, of providing the filament/fiber with a diameter suitable for subsequent use in desired applications.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Gray et al. (US 2016/0177026) in view of either one of Cordero et al. (US 2022/0072763) or Skalla et al. (US 2020/0095374) and in view of either one of Chickering et al. (WO 2018/106738) or Blum et al. (US 2018/0042843), as applied to claims 1, 2, 9, 12, 14 and 15 above, and further in view of Li et al. (US 2008/0319114) and Sherwood et al. (US 6,454,811).
As to claim 13, the combination teaches the method set forth above. Gray et al. do not teach vacuum drying the materials as claimed. However, each of Li et al. (Abstract; paragraph [0011]) and Sherwood et a. (col. 19, lines 5-15) teach analogous methods wherein the corresponding base powders and bioactive materials are vacuum dried prior to further use.
Therefore it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have combined the teaching of Gray et al. with Li et al. and Sherwood et al. and to have vacuum dried the base polymers and bioactive materials of Gray et al., as suggested by Li et al. and Sherwood et al., for the purpose, as suggested by the references of placing the materials in condition that is ready for use after synthesis (e.g. removal of moisture, unreacted materials, solvents).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jeff Wollschlager whose telephone number is (571)272-8937. The examiner can normally be reached M-F 7:00-3:30.
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/JEFFREY M WOLLSCHLAGER/Primary Examiner, Art Unit 1742