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 .
Response to Amendment
Applicant's amendment and argument filed 03/18/2026, in response to the non-final rejection, are acknowledged and have been fully considered. Any previous rejection or objection not mentioned herein is withdrawn.
Claims 1-5 and 15-18 are pending of which claims 1-5 remain withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 10/30/2025.
Claims 15-18 are being examined on the merits.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 06/13/2023 is being considered by the examiner. The signed IDS form is attached with the instant office action.
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 15-16 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Arndt Schilling et. al. (US20150023911A1) and Eric Burgett and Rebecca Howell (US20170050052A1). This is a new rejection based on the arguments and amendments filed on 03/18/2026.
Schilling teaches that the present invention relates to an in vitro or ex vivo method of preparing a cell-free composition (see abstract), comprising of multiple polymers which can be polylactic acid along with de-cellularised native tissue (see 0073 (iv) and (v)).
“A suitable acellular matrix could therefore be a nano-/micro-fibre-based material such as a hydrogel or mesh. It could also comprise a network of nano-/micro-particles. The acellular compartment may be composed of a single material or be a composite material comprising two or more different types of fibre” (see 0125). Here Schilling teaches wherein one can create a fabricated filament.
Schilling teaches that “these hydrogels can be optionally subjected to plastic compression, in which excess interstitial fluid is irreversibly removed from the hydrogel through fixed mechanical loading over a porous support, to produce a sheet of controlled cell/matrix density (depending on the level of compression/fluid removal) (Brown et al. 2005; Hadjipanayi et al. 2009b; Hadjipanayi et al. 2010a). Other scaffolds that can be used in engineering the cellular compartment include biopolymeric (e.g, collagen) sponges, decellularised extracellular matrices from various tissues (e.g. dermis, small intestinal submucosa (SIS), urinary bladder, amniotic membrane) (Badylak et al. 2009), electrospun nano-fibre (e.g. collagen, elastin, fibrinogen, glycosaminoglycans) scaffolds (Smith et al. 2008), synthetic polymers (e.g. PLGA, PEG). The scaffold material may also be a composite/hybrid material comprising two (or more) different types of biomaterials (e.g. collagen/elastin, collagen/fibrin, collagen/fibronectin, collagen/glycosaminoglycan)” (see 0119). Here Schilling teaches compressing of hydrogels comprising of scaffolds of decellularized extracellular matrices from various tissues and polymers. With the broadest reasonable interpretation the term compression can also be a synonym of the term “co-extruded” because both can mean to squeeze to from a shape.
Schilling teaches “therefore, use of native or biomimetic matrix, such as decellularised native matrix or collagen (and other biopolymeric e.g. fibrin, GAG) hydrogels (these can be optionally subjected to plastic compression), respectively, for the acellular matrix compartment are means of trapping of factors at physiological concentrations and ratios. This is preferred, not only because the optimal (i.e. physiological) concentration of several growth factors remains unknown, but also because additional, yet to be identified factors may potentially be involved in tissue repair and regeneration processes; capturing stress-induced factors within a native or biomimetic acellular matrix while they are being produced by cells, overcomes these limitations, which would not be possible by trying to reconstitute complex growth factor mixtures (either stress-induced factor or recombinant factors) at a later stage into media or any other form of vehicle. (see 0127).
Schilling also teaches wherein for seeding biomaterial matrices one can electrically activate nano-material scaffolds such as composite materials with nanoscale, piezoelectric zinc oxide particles embedded into a polymer matrix (see 0120).
Schilling also teaches applying the composition to an injury (see claim 15 and 0198-0199) and teaches wherein the cells secreting material are from xenogeneic (see claim 3, 0050 (iii), 0116, 0126), which would teach donor tissue.
Regarding claim 16, Schilling teaches “the use of bioactive growth factors is under consideration as a potential therapy to enhance healing of chondral injuries and modify the arthritic disease process. By modulating the local microenvironment, e.g. recruitment of chondrogenic cells, stimulation of chondrogenic cell proliferation and enhancement of cartilage matrix synthesis, the anabolic and anticatabolic effects of a variety of growth factors have demonstrated potential in both in vitro and animal studies of cartilage injury and repair” (see 0023). Schilling teaches the use of the growth factors being collected in carries (polymers) for delivery to tissues (see abstract and claim 17).
Regarding claim 18, Schilling teaches “The use of bioactive growth factors is under consideration as a potential therapy to enhance healing of chondral injuries and modify the arthritic disease process. By modulating the local microenvironment, e.g. recruitment of chondrogenic cells, stimulation of chondrogenic cell proliferation and enhancement of cartilage matrix synthesis, the anabolic and anticatabolic effects of a variety of growth factors have demonstrated potential in both in vitro and animal studies of cartilage injury and repair” (see 0023). This teaches that the intention of the treatment would indeed be to stimulate chondrogenesis.
Schilling does not specifically teach “co-extruding” although teaches compressing of decellularized matrix materials and polymers, therefore Burgett is relied upon to teach co-extruding.
Burgett teaches of extruder systems wherein “the extruder system provides for co-extrusion, multi-material extrusion, and custom blending of polymers in real-time during the fabrication process. This is accomplished through predictive blending protocols for the polymers coupled with a mixing vessel and feed equipment to provide the needed plastic formulation to the extruder. The formulation can be either tissue- or bone-equivalent with separate extruders for tissue and bone materials or by using one extruder capable of handling both tissue and bone formulations” (see 0055).
Therefore it would have been obvious to persons having ordinary skill in the art before the effective filing date to create a method of treating an injured tissue by applying to the injury a plurality of decellularized matrix microspheres comprising a first polymer which is polylactic acid and a second polymer, wherein the decellularized matrix microspheres and the second polymer are co-extruded in the form of a filament because Schilling teaches using the same polymers as being carries for collecting decellularized extracellular components and teaches compressing them together in order to concentrate the amount of growth factors. Schilling also teaches creating fibers (filaments). Schilling teaches compressing together the scaffolds (hydrogels made from fibers) which can also include decellularized extracellular components from various tissues to form a matrix density and teaches wherein a suitable acellular matrix could therefore be a nano-/micro-fibre-based material such as a hydrogel or mesh. It would have been obvious to “compress” or co-extrude a second polymer with that of the decellularized matrix material because Schilling teaches that they are trying to trap growth factors and teaches subjecting the hydrogels to plastic compression as a means for obtaining physiological concentrations and ratios of those factors. Encapsulating these components in the polymers/hydrogels is the basis of the treatment and so it is obvious to persons having skill in the art to compress the polymers with the decellularized matrix material to be encapsulated for treatment and for applying the filament to tissue injuries.
It would have also been obvious to look co-extrude as oppose to compress the components because Burgett teaches of extruders which are made for polymers and biomaterials. One would want to use the co-extruder taught by Burgett to stream line the process of creating the treatment fibers for the method described in Schilling’s teachings.
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Arndt Schilling et. al. (US20150023911A1) as applied to claims 15-16 and 18 above, and further in view of Takagi Mutsumi (JP2012152206A). This is a new rejection based on the arguments and amendments filed on 03/18/2026.
Schilling teaches the instantly claimed method however is silent on using porcine osteochondral tissue.
Takagi teaches “the present invention relates to an animal cartilage piece and a cartilage defect repair evaluation system using the same” (see abstract and page 4). Takagi teaches examples of cells which can be used for cartilage repair are porcine osteochondral cells (see page 6, last two para. examples at top of page 7).
Therefore it would have been obvious to persons having ordinary skill in the art before the effective filing date to use porcine osteochondral cells in the invention taught by Schilling because Schilling teaches the use of xenogeneic tissues for chondrogenic repair and Takagi teaches wherein those tissues can come from porcine sources and still be effective for such repairs. Additionally, this is commonly done in the art and so would have been prima facie obvious.
Response to Arguments
Applicant's arguments filed 03/18/2026 have been fully considered but they are not persuasive. The applicant argues that Schilling does not teach every component of creating the fabricated filament by co-extruding the polymer with the decellularized microspheres. Schilling teaches use of native or biomimetic matrix, such as decellularized native matrix or collagen (and other biopolymeric e.g. fibrin, GAG) hydrogels (these can be optionally subjected to plastic compression), respectively, for the acellular matrix compartment are means of trapping of factors at physiological concentrations and ratios. Subjecting the decellularized native matrix material and “scaffolds” or PGA to form filaments (fibers) is the mechanism of encapsulating the bioactive factors. Schilling is teaching of methods for obtaining the cellular and extracellular components form cells (growth factors), embedded in carriers and scaffolds which are compressed together in order to maximize concentrations of those factors. Schilling teaches the acellular compartment may be composed of a single material or be a composite material comprising two or more different types of fibre (filaments). This teaches creating a fabricated filament. Schilling teaches of electrospun nano-fibres (e.g. collagen, elastin, fibrinogen, glycosaminoglycans) scaffolds (Smith et al. 2008) and synthetic polymers (e.g. PLGA, PEG). The scaffold material may also be a composite/hybrid material comprising two (or more) different types of biomaterials. Thus using PGA polymer and the decellularized material together to create a filament or fiber is obvious and creating more than one is also obvious. Additionally, Burgett teaches of extruder systems that provides for co-extrusion, multi-material extrusion, and custom blending of polymers for biomaterials. Thus coextrusion of these components would have been obvious given the relied upon art.
The applicant argues that Schilling does not describe microsphere encapsulating decellularized donor tissue, but Schilling teaches capturing the growth factors from xenogeneic cells (see claim 3). The applicant argues that Schilling does not describe a microsphere that is itself a composite material comprised of both a polymer and decellularized tissue encapsulated within the polymer. Schilling may not use the same language as the applicant; however Schilling does teach wherein the decellularized xenogeneic components are trapped in the scaffold which comprises of both decellularized matrix components and polymers and teaches wherein they are intended to be compressed in order to obtain the maximum amount of growth factors used in treating patients. The examination is to a method of treating and not necessarily to a method of creating a filament, inasmuch Schilling makes obvious the use of multiple fibers (filaments) which can be compressed in creating hydrogels along with the decellularized material and polymers to capture growth factors for delivery to a patient.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JACOB ANDREW BOECKELMAN whose telephone number is (571)272-0043. The examiner can normally be reached Monday-Friday 8am-5pm.
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JACOB A BOECKELMANExaminer, Art Unit 1655
/ANAND U DESAI/Supervisory Patent Examiner, Art Unit 1655
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