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
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.
Claim(s) 1-7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ferracini et al (Composite Xenohybrid Bovine Bone-Derived Scaffold as Bone Substitute for the Treatment of Tibial Plateau Fractures, 2019, APPLIED SCIENCES, vol. 9, no. 13, page 2675) "Ferracini" in view of Moseley et al (WO 2019231562 A1) "Moseley".
Regarding Claim 1, Ferracini discloses a scaffold for bone regeneration, comprising a support structure made with a composite hybrid formed by a bovine bone-derived matrix reinforced with at least one polymer and containing collagen fragments (Featured Application, See page 1, #5 in particular), but does not disclose a support structure functionalized with secretome. However, Moseley, in the same field of art, teaches mesenchymal stem cells (MSC) secretome designed to be composed within a support structure, the support structure being functionalized with secretome (par 4). 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 structure disclosed by Ferracini to include a support structure functionalized with secretome, as taught by Moseley, in order for the structure to provide treatment for wounds or various diseases (Moseley, par 1).
Regarding Claim 2, Ferracini does not disclose mesenchymal stem cell secretome. However, Moseley, in the same field of art, teaches the scaffold according to claim 1, wherein the secretome is mesenchymal stem cell secretome (pars 1 and 4). 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 structure disclosed by Ferracini to include mesenchymal stem cell secretome, as taught by Moseley, in order for the structure to provide treatment for wounds or various diseases, as mesenchymal stem cells are able to differentiate into multiple cell types that can have different immunomodulatory abilities (Moseley, par 1).
Regarding Claim 3, Ferracini does not disclose lyosecretome. However, Moseley, in the same field of art, teaches the scaffold according to claim 1, wherein the secretome is lyosecretome (lyophilized secretome) (par 3). 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 structure disclosed by Ferracini to include lyosecretome (lyophilized secretome), as taught by Moseley, in order to have a different MSC secretome composition, which can allow for different treatment methods (Moseley, par 5).
Regarding Claim 4, Ferracini does not disclose secretome containing proteins and extracellular vesicles. However, Moseley, in the same field of art, teaches the scaffold according to claim 1, wherein the secretome contains both a soluble fraction, in particular comprising proteins, and an insoluble particulate fraction, in particular extracellular vesicles (par 47). 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 structure disclosed by Ferracini to include secretome containing proteins and extracellular vesicles, as taught by Moseley, in order to have a different MSC secretome composition, which can allow for different treatment methods (Moseley, pars 5 and 47).
Regarding Claim 5, Ferracini does not disclose secretome containing proteins and lipids. However, Moseley, in the same field of art, teaches the scaffold according to claim 1 wherein the secretome contains proteins and lipids (par 34 and 47). 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 structure disclosed by Ferracini to include secretome containing proteins and lipids, as taught by Moseley, in order to have a different MSC secretome composition, which can allow for different treatment methods (Moseley, pars 5, 34, and 47).
Regarding Claim 6, Ferracini further discloses the scaffold according to claim 1, wherein the bovine bone-derived matrix is reinforced with poly (L-lactide-co-s-caprolactone) (PLCL) (Featured Application, See page 1). 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 structure disclosed by the first embodiment of Ferracini to further include bovine bone-derived matrix reinforced with poly (L-lactide-co-s-caprolactone) (PLCL), in order to improve elasticity and cell attachment (Introduction, par 4, See page 2).
Regarding Claim 7, Ferracini further discloses the scaffold according to claim 1, wherein the collagen fragments are of animal origin (Featured Application, See page 1). 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 structure disclosed by the first embodiment of Ferracini to further include collagen fragments of animal origin, in order to improve elasticity and cell attachment (Introduction, par 4, See page 2).
Claim(s) 8-11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ferracini et al (Composite Xenohybrid Bovine Bone-Derived Scaffold as Bone Substitute for the Treatment of Tibial Plateau Fractures, 2019, APPLIED SCIENCES, vol. 9, no. 13, page 2675) "Ferracini" in view of Moseley et al (WO 2019231562 A1) "Moseley" in further view of Diomede et al (Three-dimensional printed PLA scaffold and human gingival stem cell-derived extracellular vesicles: a new tool for bone defect repair, 2018, Stem Cell Research & Therapy, vol 9, no. 104) “Diomede”.
Regarding Claim 8, Ferracini does not disclose a scaffold for bone regeneration prepared by 3D printing and loaded with secretome. However, Diomede, in the same field of art, teaches a method for manufacturing the scaffold for bone regeneration, comprising the steps of: preparing the support structure by 3D printing (Methods, See pages 2 and 3). Moseley, in the same field of art teaches loading the support structure with the secretome (par 4). 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 structure disclosed by Ferracini to include a scaffold for bone regeneration prepared by 3D printing and loaded with secretome, as disclosed by Moseley and Diomede, in order for the structure to provide treatment for wounds or various diseases (Moseley, par 1) and for three-dimensional support to favor cell adhesion, migration, and differentiation in vivo (Diomede, Background, See page 2).
Regarding Claim 9, Ferracini as modified by Diomede does not disclose adsorption of the secretome onto the support structure. However, Moseley, in the same field of art, teaches the manufacturing method according to claim 8, wherein the step of loading the support structure with the secretome is carried out by adsorption of the secretome onto the support structure (pars 3 and 4; the secretome can be a protective coating, which is a form of adsoprtion on the support structures listed in par 4). 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 structure disclosed by Ferracini to include adsorption of the secretome onto the support structure, as taught by Moseley, in order to reduce degradation of growth factors and extracellular vesicles (Moseley, par 3).
Regarding Claim 10, Ferracini as modified by Diomede does not disclose immersion of the support structure in a solution containing the secretome, and subsequent lyophilization. However, Moseley, in the same field of art, teaches the manufacturing method according to claim 9, wherein the secretome is loaded onto the support structure by immersion of the support structure in a solution containing the secretome, and subsequent lyophilization (pars 3 and 54). 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 structure disclosed by Ferracini to include immersion of the support structure in a solution containing the secretome, and subsequent lyophilization, as taught by Moseley, in order to have a different MSC secretome composition, which can allow for different treatment methods (Moseley, par 5) and to reduce degradation of growth factors and extracellular vesicles (Moseley, par 3).
Regarding Claim 11, Ferracini as modified by Diomede does not disclose secretome in solution with poloxamer 407 and/or NaCI. However, Moseley, in the same field of art, teaches the manufacturing method according to claim 9 wherein the secretome is in solution with poloxamer 407 and/or NaCI (pars 48 and 69). 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 structure disclosed by Ferracini to include secretome in solution with poloxamer 407 and/or NaCI, as taught by Moseley, in order to maintain biocompatitibility and provide a solution that will not impact the effectiveness of the secretome (Moseley, pars 48 and 69).
Conclusion
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/NATALIE N THOMAS/Examiner, Art Unit 3774
/KATRINA M STRANSKY/Primary Examiner, Art Unit 3700
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