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 III, a method of using a composition in the reply filed on 11/10/2025 is acknowledged.
Priority
The instant application claims domestic priority to PRO 63/042,006 filed 06/21/2020 and is a 371 of PCT/JP2021/023279 filed 06/18/2021.
Information Disclosure Statement
The information disclosure statement filed 11/10/2025 fails to comply with 37 CFR 1.98(a)(2), which requires a legible copy of each cited foreign patent document; each non-patent literature publication or that portion which caused it to be listed; and all other information or that portion which caused it to be listed. It has been placed in the application file, but the information referred to therein has not been considered if crossed out. NPL literature No. 1 and 2 are not legible, NPL literature No. 4, 15, and 16 do not provide copies included with the present IDS.
The information disclosure statement (IDS) dated 04/25/2023 complies with provisions of 37 CFR 1.97, 1.98 and MPEP §609. Accordingly, it has been placed in the application file and the information therein has been considered as to the merits.
Claim Rejections - 35 USC § 103
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 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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 55-58 are rejected under 35 U.S.C. 103 as being unpatentable over Kusuga et al. (US Patent Application Publication 20180280569 A1) and Alvarez et al. (US Patent Application Publication 20140037593 A1).
Kusuga recites method for producing a bone-regeneration material comprising biodegradable fiber using an electrospinning process, comprising: providing a PLGA resin to a kneader and heating the PLGA resin while rotating a blade of the kneader to soften the PLGA resin to a viscosity of 102 to 107 Pa·s; mixing powder of calcium phosphate fine particles with the softened PLGA resin by providing the powder into the kneader while rotating the blade; rotating the blade of the kneader with continuous force under the heating to knead the mixture so that thermal and mechanical energy is applied to the mixture to produce a composite of the PLGA resin and the calcium phosphate fine particles dispersed in the PLGA resin; cooling and solidifying the composite; dissolving the composite with a solvent, and stirring the dissolved composite for a predetermined time to prepare a spinning solution in which the PLGA resin is completely dissolved by the solvent and the calcium phosphate fine particles are substantially uniformly dispersed in the solvent; and charging the spinning solution into a syringe of an electrospinning apparatus and applying voltage to produce a biodegradable fiber in which the calcium phosphate fine particles are substantially uniformly dispersed (Kusuga at claim 1). Kusuga recites wherein the calcium phosphate fine particles are β-TCP fine particles (Kusuga at claim 3). Kusuga recites wherein the PLGA resin and the calcium phosphate fine particles are provided to the kneader in a ratio of from about 30 to 50 wt % and from about 70 to 50 wt %, respectively (Kusuga at claim 4).
Kusuga teaches wherein the biodegradable fiber includes about 30 to 60% by weight of PLGA resin and about 70 to 40% by weight of calcium phosphate fine particle (Kusuga at [0029]). Kusuga teaches the outer diameter of the biodegradable fiber is 10 to 250 μm (Kusuga at [0040]). Kusuga teaches that because the biodegradable fiber that contains a PLGA resin as a biodegradable resin produced by the method for producing a bone regeneration material of the present invention is degraded and absorbed rapidly in the body, it allows early controlled release of β-TCP and promotes the bone formation (Kusuga at [0045]). Kusuga teaches that the bone-regeneration material produced may be used singly as well as by a method involving filling a bone defect with an autologous bone wrapped with the cottonwool-like material. The bone regeneration material is used to fill a defect and helps the bone formation in that state because of a high affinity with the autologous bone (Kusuga at [0163]).
The teachings of Kusuga differ from the instant claim insofar as they do not teach the BMP coating. The teachings of Alvarez cure this deficit.
Alvarez recites composition comprising a beta-tricalcium phosphate β-TCP bound to one or more β-TCP binding peptides (Alvarez at claim 1). Alvarez recites wherein the β-TCP is a β-TCP scaffold (Alvarez at claim 2). Alvarez recites wherein the scaffold further comprises polylactide-co-glycide (Alvarez at claim 3). Alvarez recites wherein the one or more additional peptides or proteins is an epidermal growth factor (EGF), a platelet-derived growth factor (PDGF), a bone morphogenic protein 2 (BMP-2), BMP-4, BMP-7, osteogenic protein (OP-1), collagen binding protein or a combination thereof (Alvarez at claim 13). Alvarez recites method of delivering epidermal growth factor (EGF) to an individual in need thereof, comprising administering to the individual an effective amount of a composition comprising a beta-tricalcium phosphate (β-TCP) bound to a β-TCP binding peptides, wherein the β-TCP binding peptide is fused to an epidermal growth factor (EGF) (Alvarez at claim 30). Alvarez recites wherein the wound site comprises a bone injury (Alvarez at claim 32). Alvarez recites method of repairing bone in an individual in need thereof, comprising administering to the individual an effective amount of a composition comprising a beta-tricalcium phosphate (β-TCP) scaffold bound to one or more β-TCP binding peptides, wherein the one or more β-TCP binding peptides are fused to EGF (Alvarez at claim 36). Alvarez teaches that although the intrinsic properties of BTCP favor bone healing in many clinical applications, addition of osteogenic growth factors BMP-2 and OP-1 to BTCP scaffolds at the time of implant enhances healing in both experimental animal models and clinical applications (Friedlaender, G. E. et al., Vol. 83 151-158 (JBJS, 2001)). (Alarez at [0067]). Alvarez teaches as appreciated by those of skill in the art a variety of proteins and/or peptides can be fused to the β-TCP binding peptide. The additional protein and/or peptide can be fused at either the N terminal end of the β-TCP binding peptide, the C terminal end of the β-TCP binding peptide or within the β-TCP binding peptide. Examples of such proteins and portions thereof (e.g., peptides) include growth factors (e.g., epidermal growth factor, platelet-derived growth factor (PDGF), IGF, FGF, TGF (TGF-α; TGF-β)), cytokines (bone morphogenetic protein (BMP), hormones, insulin, and enzymes. Specific examples include heregulin, neuregulin (NRG, such as NRGβ1), morphogenic protein stimulatory factor (MPSF), osteogenic protein (OP, such as OP-1, OP-2, OP-3), BMP-2, BMP-3, BMP-4, BMP-5, BMP-6, BMP-7, BMP-9, BMP-10, BMP-11, BMP-13, BMP-15, DPP, Vg1, Vgr, GDF-1, GDF-3, GDF-5, GDF-6, GDF-7, matrix binding proteins such as hyaluronic binding protein, and collagen binding protein (Alarez at [0062]). Alvarez teaches a method of delivering a protein and/or peptide (e.g., EGF, BMP-2, OP-1) to an individual in need thereof comprising administering to the individual an effective amount of a composition comprising one or more β-TCP bound to one or more β-TCP binding peptides, wherein the one or more β-TCP binding peptides are fused to the protein and/or peptide that is to be delivered. (Alarez at [0088]). Alvarez teaches the composition can be administered, for example, to a wound site, such as a bone injury (Alarez at [0088]).Alvarez teaches a method of repairing bone in an individual in need thereof, comprising administering to the individual a composition comprising a beta-tricalcium phosphate (β-TCP) scaffold bound to one or more β-TCP binding peptide (Alarez at [0089]). Alvarez teaches the use of β-TCP and polylactide-co-glycolide to form a scaffold (Alarez at [0095-0096]). Alvarez teaches that as will be appreciated by those of skill in the art, the β-TCP can be used in a variety of forms. Examples of such forms include a granular form, a porous form, a powder, a putty (e.g., a moldable putty), a paste and/or a scaffold. In addition, the β-TCP can be used in a variety of shapes (e.g., a cross, a ladder, a circle, a square, a triangle, etc.) and sizes (e.g., about 1 mm, 2 mm, 3 mm, 4 mm, 5 mm, 6 mm, 7 mm, 8 mm, 9 mm, 1 cm, 2 cm, 3 cm, 4 cm, 5 cm, 6 cm, 7 cm, 8 cm, 9 cm, 10 cm, etc.) (Alvarez at [0048]).
The teachings of Alvarez differ from the instant claim insofar as they do not specifically teach the diameter of the β-TCP. The teachings of Kusuga cure this deficit.
It would have been prima facie obvious for one of ordinary skill to have added the BMP coating of Alvarez to the composition of Kusuga for the benefit of enhanced healing taught by Alvarez. See MPEP 2144(II).
One would have been motivated to have added the BMP coating of Alvarez to the composition of Kusuga for the benefit of enhanced healing taught by Alvarez.
It would have been prima facie obvious for one of ordinary skill to have optimized the length of the scaffold or fibers given the teaching of sizes between 1mm and 10cm of Alvarez in order to provide the appropriate size and shape scaffolds for individual bone defects. See MPEP 2144.05(II).
Regarding instant claim 55, Kusuga recites method for producing a bone-regeneration material comprising biodegradable fiber using an electrospinning process (Kusuga at claim 1). Kusuga teaches that the bone-regeneration material produced may be used singly as well as by a method involving filling a bone defect with an autologous bone wrapped with the cottonwool-like material. The bone regeneration material is used to fill a defect and helps the bone formation in that state because of a high affinity with the autologous bone (Kusuga at [0163]). Kusuga recites wherein the calcium phosphate fine particles are β-TCP fine particles (Kusuga at claim 3). Kusuga teaches wherein the biodegradable fiber includes about 30 to 60% by weight of PLGA resin and about 70 to 40% by weight of calcium phosphate fine particle (Kusuga at [0029]), which overlaps the instantly claimed range of 43 to 60%. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP§2144.05(I).Kusuga teaches the outer diameter of the biodegradable fiber is 10 to 250 μm (Kusuga at [0040]), which overlaps the instantly claimed range of 40 to 320 μm. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP§2144.05(I). Alvarez teaches the binding of BMP-2 to β-TCP (Alarez at [0062]) for the benefit of enhanced healing (Alarez at [0067]). Alvarez further teaches the scaffold may be 1mm to 10mm (Alvarez at [0048]), which overlaps the instantly claimed range of 5 to 20 mm. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP§2144.05(I).
Regarding instant claim 56, Kusuga teaches that the bone-regeneration material produced may be used singly as well as by a method involving filling a bone defect with an autologous bone wrapped with the cottonwool-like material. The bone regeneration material is used to fill a defect and helps the bone formation in that state because of a high affinity with the autologous bone (Kusuga at [0163]).
Regarding instant claim 57, Kusuga recites method for producing a bone-regeneration material comprising biodegradable fiber using an electrospinning process (Kusuga at claim 1). Kusuga teaches that the bone-regeneration material produced may be used singly as well as by a method involving filling a bone defect with an autologous bone wrapped with the cottonwool-like material. The bone regeneration material is used to fill a defect and helps the bone formation in that state because of a high affinity with the autologous bone (Kusuga at [0163]). Kusuga recites wherein the calcium phosphate fine particles are β-TCP fine particles (Kusuga at claim 3). Kusuga teaches wherein the biodegradable fiber includes about 30 to 60% by weight of PLGA resin and about 70 to 40% by weight of calcium phosphate fine particle (Kusuga at [0029]), which overlaps the instantly claimed range of 45 to 60%. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP§2144.05(I). Kusuga teaches the outer diameter of the biodegradable fiber is 10 to 250 μm (Kusuga at [0040]), which overlaps the instantly claimed range of 40 to 320 μm. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP§2144.05(I). Alvarez teaches the binding of BMP-2 to β-TCP (Alarez at [0062]) for the benefit of enhanced healing (Alarez at [0067]). Alvarez further teaches the scaffold may be 1mm to 10mm (Alvarez at [0048]), which overlaps the instantly claimed range of 5 to 20 mm. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP§2144.05(I).
Regarding instant claim 58, Kusuga teaches that the bone-regeneration material produced may be used singly as well as by a method involving filling a bone defect with an autologous bone wrapped with the cottonwool-like material. The bone regeneration material is used to fill a defect and helps the bone formation in that state because of a high affinity with the autologous bone (Kusuga at [0163]).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
A) Claims 55-58 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 63-78 of copending Application No. 17/908,835 in view of Kusuga et al. (US Patent Application Publication 20180280569 A1) and Alvarez et al. (US Patent Application Publication 20140037593 A1).
The instant application claims a method of treating a subject in need thereof, comprising administering to the subject a composition produced by method comprising combining a scaffold with aBMP-2,wherein the scaffold comprises electrospun biodegradable fibers, wherein the electrospun biodegradable fibers are 40-320 um in diameter and 5-20mm in length, wherein 43-60% of the electrospun biodegradable fibers by volume are p-TCP,wherein a portion of the (3-TCP is exposed on a surface of the electrospun biodegradable fibers, and wherein BMP-2 is bound to (3-TCP exposed on the surface of the electrospun biodegradable fibers (instant application at claim 55).
The reference application 835 recites a method of promoting bone or cartilage formation in a subject in need thereof, the method comprising administering to the subject a therapeutically effective amount of a composition comprising: a) a first graft material comprising synthetic calcium phosphate, b) a second graft material comprising a bone allograft, and c) a mammalian growth factor (‘835 at claim 73). The reference application 835 recites method of replacing and/or repairing bone or cartilage in a subject in need thereof, the method comprising administering to the subject a therapeutically effective amount of a composition comprising: a) a first graft material comprising synthetic calcium phosphate, b) a second graft material comprising a bone allograft, and c) a mammalian growth factor (‘835 at claim 74). The reference application 835 recites method of treating a bone fracture or bone loss in a subject in need thereof, the method comprising administering to the subject a therapeutically effective amount of a composition comprising: a) a first graft material comprising synthetic calcium phosphate, b) a second graft material comprising a bone allograft, and c) a mammalian growth factor (‘835 at claim 75). The reference application 835 recites kit comprising a) a first graft material comprising synthetic calcium phosphate, b) a second graft material comprising a bone allograft, and c) a mammalian growth factor (‘835 at claim 63). The reference application 835 recites wherein the mammalian growth factor is an epidermal growth factor (EGF), platelet derived growth factor (PDGF), insulin like growth factor (IGF-1), fibroblast growth factor (FGF), fibroblast growth factor 2 (FGF2), fibroblast growth factor 18 (FGF 18), transforming growth factor alpha (TGF-a), transforming growth factor beta (TGF-j3), transforming growth factor beta 1 (TGF-3 1), transforming growth factor beta 3 (TGF-33), osteogenic protein 1 (OP-1), osteogenic protein 2 (OP-2), osteogenic protein 3 (OP-3), bone morphogenetic protein 2 (BMP-2), bone morphogenetic protein 3 (BMIP-3), bone morphogenetic protein 4 (BMIP-4), bone morphogenetic protein 5 (BMP-5), bone morphogenetic protein 6 (BMIP-6), bone morphogenetic protein 7 (BMP-7), bone morphogenetic protein (BMP-9), bone morphogenetic protein 10 (BMP-10), bone morphogenetic protein 11 (BMP-1 1), bone morphogenetic protein 12 (BMIP-12) bone morphogenetic protein 13 (BMP-13), bone morphogenetic protein 15 (BMP- 15), dentin phosphoprotein (DPP), vegetal related growth factor (Vgr), growth differentiation factor 1 (GDF- 1), growth differentiation factor 3 (GDF-3), growth differentiation factor 5 (GDF-5), growth differentiation factor 6 (GDF-6), growth differentiation factor 7 (GDF-7), growth differentiation factor 8 (GDF8), growth differentiation factor 11 (GDF 11), growth differentiation factor 15 (GDF 15), vascular endothelial growth factor (VEGF), hyaluronic acid binding protein (HABP), collagen binding protein (CBP), fibroblast growth factor 18 (FGF-18), keratinocyte growth factor (KGF), tumor necrosis factor alpha (TNFa), tumor necrosis factor (TNF)- related apoptosis inducing ligand (TRAIL), wnt family member 1 (WNT1), wnt family member 2 (WNT2), wnt family member 2B (WNT2B), wnt family member 3 (WNT3), wnt family member 3A (WNT3A), wnt family member 4 (WNT4), wnt family member 5A (WNT5A), wnt family member 5B (WNT5B), wnt family member 6 (WNT6), wnt family member 7A (WNT7A), wnt family member 7B (WNT7B), wnt family member 8A (WNT8A), wnt family member 8B (WNT8B), wnt family member 9A (WNT9A), wnt family member 9B (WNT9B), wnt family member 1OA (WNT1OA), wnt family member 1OB (WNT1OB), wnt family member 11 (WNT11), or wnt family member 16 (WNT16) (‘835 at claim 64). The reference application 835 recites wherein the first graft material comprises a polymer (‘835 at claim 69). The reference application 835 recites wherein the polymer comprises polylactide-co- glycolic acid (PLGA) (‘835 at claim 70). The reference application 835 recites wherein the synthetic calcium phosphate comprises beta-tricalcium phosphate (‘835 at claim 63). The reference application 835 recites wherein the mammalian growth factor is bound to the first graft material (‘835 at claim 72).
The teachings of Kusuga and Alvarez are discussed above.
It would have been prima facie obvious to have used the amount of beta-tricalcium phosphate and size of the scaffolds taught by Kusuga and Alvarez as this is an amount, size and length taught to have been useful in bone repair compositions. See MPEP 2144.07.
Reference claims and prior art combine to produce a prima facie case of obviousness type non-statutory double patenting.
This is a provisional nonstatutory double patenting rejection.
B) Claims 55-58 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 172, 174-175, and 179-194 of copending Application No. 17/636,527 in view of Kusuga et al. (US Patent Application Publication 20180280569 A1) and Alvarez et al. (US Patent Application Publication 20140037593 A1).
The instant application claims a method of treating a subject in need thereof, comprising administering to the subject a composition produced by method comprising combining a scaffold with aBMP-2,wherein the scaffold comprises electrospun biodegradable fibers, wherein the electrospun biodegradable fibers are 40-320 um in diameter and 5-20mm in length, wherein 43-60% of the electrospun biodegradable fibers by volume are p-TCP,wherein a portion of the (3-TCP is exposed on a surface of the electrospun biodegradable fibers, and wherein BMP-2 is bound to (3-TCP exposed on the surface of the electrospun biodegradable fibers (instant application at claim 55).
The reference application ‘527 recites method of treating a condition in a subject in need thereof, the method comprising administering to the subject the device of claim 172 (‘527 at claim 184). The reference application ‘527 recites wherein the condition comprises a bone defect (‘527 at claim 185). The reference application ‘527 recites method of treating a bone defect in a subject in need thereof, the method comprising administering to the subject the device of claim 183 (‘527 at claim 191). The reference application ‘527 recites device comprising a BMP-2 of SEQ ID NO: 454 coated on, wherein the three-dimensional structure comprises a ceramic and a polymer, the ceramic is present in the three-dimensional structure at about 50% to about 90% by weight, and the polymer is present in the three-dimensional structure at about 10% to about 50% by weight, wherein the ceramic comprises calcium phosphate, and the polymer comprises polycaprolactone, wherein the BMP-2 of SEQ ID NO: 454 is retained on the three-dimensional structure via a non-covalent bond (‘527 at claim 172). The reference application ‘527 recites wherein the calcium phosphate is beta- tricalcium phosphate (‘527 at claim 175).
The teachings of Kusuga and Alvarez are discussed above.
It would have been prima facie obvious to have used the size of the scaffolds taught by Kusuga and Alvarez as this is an diameter and length taught to have been useful in bone repair compositions. See MPEP 2144.07.
Reference claims and prior art combine to produce a prima facie case of obviousness type non-statutory double patenting.
This is a provisional nonstatutory double patenting rejection.
C) Claims 55-58 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-20 of copending Application No. 17/871,734 in view of Kusuga et al. (US Patent Application Publication 20180280569 A1) and Alvarez et al. (US Patent Application Publication 20140037593 A1)
The instant application claims a method of treating a subject in need thereof, comprising administering to the subject a composition produced by method comprising combining a scaffold with aBMP-2,wherein the scaffold comprises electrospun biodegradable fibers, wherein the electrospun biodegradable fibers are 40-320 um in diameter and 5-20mm in length, wherein 43-60% of the electrospun biodegradable fibers by volume are p-TCP,wherein a portion of the (3-TCP is exposed on a surface of the electrospun biodegradable fibers, and wherein BMP-2 is bound to (3-TCP exposed on the surface of the electrospun biodegradable fibers (instant application at claim 55).
The reference applicant ‘734 recites a method of bone regeneration therapy with a reduced an adverse effect associated with release of bone morphogenetic protein-2 (BMP-2) to an unintended site of a subject during the bone regeneration therapy, the method comprising introduction of BMP-2 to the subject, the method comprising: introducing at a treatment site of the subject a bone regeneration material comprising the BMP-2 and an electrospun structure of biodegradable fibers comprising poly(lactic-co-glycolic acid) (PLGA) at about 15-50 wt% of the structure and calcium phosphate particles at about 50-85 wt% of the structure, wherein the BMP-2 is a targetable BMP-2 comprising a binding peptide bound to calcium phosphate particles of the structure to prevent the targetable BMP-2 from diffusing to the unintended site of the subject during the bone regeneration therapy, and wherein the binding peptide comprises LLADTTHHRPWT (SEQ ID NO: 1) (‘734 at claim 1). The reference applicant ‘734 recites wherein the calcium phosphate particles comprise β-TCP particles, or silicon-doped vaterite (SiV) particles, or a combination of β-TCP particles and SiV particles (‘734 at claim 6). The reference applicant ‘734 recites wherein the calcium phosphate particles comprise β-TCP particles (‘734 at claim 7). The reference applicant ‘734 recites a method of bone formation in a subject in need thereof, the method comprising: introducing a bone regeneration material at a treatment site of the subject, wherein the bone regeneration material comprises a bone morphogenetic protein-2 (BMP-2) and an electrospun structure of biodegradable fibers comprising poly(lactic-co-glycolic acid) (PLGA) at about 15-50 wt% of the structure and calcium phosphate particles at about 50- 85 wt% of the structure, wherein the BMP-2 is a targetable BMP-2 comprising a binding peptide, and the targetable BMP-2 is bound to the calcium phosphate particles of the structure via the binding peptide, wherein the bone formation occurs at the treatment site, and the bone formation does not occur at an unintended site away from the treatment site, and wherein the binding peptide comprises LLADTTHHRPWT (SEQ ID NO: 1) (‘734 at claim 15). The reference applicant ‘734 recites wherein the PLGA is biodegradable, and the targetable BMP-2 is retained at the treatment site during biodegradation of the PLGA (‘734 at claim 16). The reference applicant ‘734 recites wherein the calcium phosphate particles comprise β-TCP particles, or silicon-doped vaterite (SiV) particles, or a combination of β-TCP particles and SiV particles (‘734 at claim 18).
The teachings of Kusuga and Alvarez are discussed above.
It would have been prima facie obvious to have used the amount of beta-tricalcium phosphate and size of the scaffolds taught by Kusuga and Alvarez as this is an amount, diameter, and length taught to have been useful in bone repair compositions. See MPEP 2144.07.
Reference claims and prior art combine to produce a prima facie case of obviousness type non-statutory double patenting.
This is a provisional nonstatutory double patenting rejection.
Conclusion
No claims are presently allowable.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMANDA MICHELLE PETRITSCH whose telephone number is (571)272-6812. The examiner can normally be reached M-F 08:30-17:00 EST ALT Fridays.
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/AMANDA MICHELLE PETRITSCH/Examiner, Art Unit 1612
/SAHANA S KAUP/Supervisory Primary Examiner, Art Unit 1612