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 § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-10, 12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Brown, US 2021/0162097 A1.
Regarding claim 1, Brown discloses a printable, biocompatible scaffold (paras [0102]-[0107]; 3-D printing of biological scaffolds) comprising: a first layer comprising a first material (para [0122]; first of the plurality of films/assemblies of bio-ink); and a second layer comprising a second material (para [0122]; second of the plurality of films/assemblies) that is different from the first material (para [0122]; different bio-ink compositions); wherein the scaffold includes a first region having a first thickness (3D material can vary incrementally to have a first region with a first thickness, para [0122]) and a second region having a second thickness (step-wise or different topographical features that would make up a second region with second thickness, para [0122]) that is greater than the thickness of the first region (thickness can vary or be greater, for example a step-wise region has a second region that is greater in thickness, para [0122]).
Regarding claims 2-3, Brown discloses the scaffold of claim 1, further comprising a first support material integrated into the first layer and a second support material integrated into the second layer (bio-ink compositions, see para [0110] and also para [0117]; support material is viscosity control agent and/or one of the other synthetic or natural polymers).
Regarding claims 4-5, Brown discloses the scaffold of claim 1, wherein the first material is a synthetic polymer (para [0111]) and wherein the second material is a synthetic polymer (para [0111]).
Regarding claim 6, Brown discloses the scaffold of claims 4 or 5, wherein the synthetic polymer is selected from the group consisting of poly(urethanes), poly(siloxanes) or silicones, poly(ethylene), poly(vinyl pyrrolidone), poly(2-hydroxy ethyl methacrylate), poly(N-vinyl pyrrolidone), poly(methyl methacrylate), poly(vinyl alcohol), poly(acrylic acid), polyacrylamide, poly(ethylene-co-vinyl acetate), poly(ethylene glycol), poly(methacrylic acid), polylactic acid (PLA), poly(L-lactic acid) (PLLA), polyglycolic acids (PGA), poly(lactide-co-glycolides) (PLGA), polycaprilactone (PCL), tri-calcium phosphate (TCP), polycaprilactone-tri-calcium phosphate (PCL-TCP), nylons, polyamides, polyanhydrides, poly(ethylene-co-vinyl alcohol) (EVOH), polycaprolactone, poly(vinyl acetate) (PVA), polyvinylhydroxide, poly(ethylene oxide) (PEO), polyorthoesters, any combinations thereof (see para [0111]).
Regarding claims 7-8, Brown discloses the scaffold of claim 1, wherein the first material is a biological material and wherein the second material is a biological material (bio-ink compositions with naturally derived polymers such as fibrin, see paras [0111] and [0117]).
Regarding claim 9, Brown discloses the scaffold of claim 8, wherein the biological material is selected from the group
consisting of collagen, fibrin, fibrinogen, thrombin, elastin, laminin, fibronectin, hyaluronic acid, chondroitin 4-sulfate, chondroitin 6-sulfate, dermatan sulfate, gelatin, heparin sulfate, heparin, keratan sulfate, proteoglycans, polysaccharides, chitin, chitosan, alginic acids, and alginates and any combinations thereof (see paras [0111] and [0117]).
Regarding claim 10, Brown discloses the scaffold of claims 9, wherein the first layer is a synthetic polymer and the second layer is a biological material (paras [0110]-[0117]; bio-ink compositions can include synthetic and/or naturally derived polymers or materials).
Regarding claim 12, Brown discloses the scaffold of claim 1, wherein the first or second layer comprises both a synthetic polymer and a biological material (paras [0110]-[0117]; bio-ink compositions can include synthetic and/or naturally derived polymers or materials).
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.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Brown in view of Crook et al, WO 2022/082259 A1.
Regarding claim 11, Brown discloses the scaffold of claim 8, wherein the biological material is collagen (para [0117]), but is silent as to the collagen is applied via electrocompaction.
However, Crook, in the same field of art, namely biocompatible tissue scaffolds (page 2, lines 5-15), teaches a scaffold having multiple layers, formed of material, wherein the material is a biological material (page 7, lines 20-40 and also page 22, lines 20-40), and wherein the biological material is collagen, the collagen is applied via electrocompaction (page 22, lines 20-40).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to make the second material of Brown with collagen applied via electrocompaction as taught by Crook in order to provide the stated advantages of creating densely packed and highly ordered bundles to form the scaffold, as is in known in the art, and since electrocompaction is a known method it would lead to predictable results and have a reasonable expectation of success (Crook, page 22, lines 30-40).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATRINA M STRANSKY whose telephone number is (571)270-3843. The examiner can normally be reached Monday-Friday 8:30 am-5:00 pm EST.
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/KATRINA M STRANSKY/Primary Examiner, Art Unit 3700