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
This action is entered in response to Applicant’s amendment and reply of August 26, 2026. Claim 1 is amended. Claims 1-12 are pending.
Response to Arguments
Applicant’s arguments, see Remarks, filed August 26, 2026, with respect to the rejections of claims 1-10, 12 under 35 U.S.C. 102(a)(1) as being anticipated by Brown, US 2021/0162097 A1, and claim 11 under 35 U.S.C. 103 over Brown in view of Crook et al, WO 2022/082259 A1 have been fully considered and are persuasive in combination with the amendments to the claims, which changes the scope of the claim. Therefore, the rejections have been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Pulapura, US 2017/0319193 A1.
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 Pulapura et al, US 2017/0319193 A1.
Regarding claim 1, Pulapura discloses a printable, biocompatible scaffold (20, 22, paras [0066]-[0078]; biocompatible substrate, para [0071]; 3D printing, para [0097]) comprising: a first layer comprising a first material (28 and/or 30, para [0091]); and a second layer comprising a second material (24 and/or 30, para [0094]; also para [0115]; multiple layers made up of different first and second polymers and/or the hemostatic agent 24) that is different from the first material (para [0115]; [0116]; layers 28 and 30 can be made of different polymers); wherein the scaffold includes a first region having a first thickness (fold area 32 with thickness, para [0079]) and a second region having a second thickness (area of surfaces 28a, 30a, having a second thickness, para [0079]) that is greater than the thickness of the first region (para [0079]); wherein a transition from the first thickness to the second thickness is configured to create a hinge configured to fold around an edge of soft tissue (paras [0079]-[0080]; regions 32 are thinner than the surrounding regions and therefore are capable of folding or creating a hinge region to allow the folding); and wherein the first thickness is configured to be disposed below the soft tissue and the second thickness is configured to be disposed at the edge of the soft tissue (paras [0070] and [0080]; substrate 22 can be folded and therefore capable of having the first and second thickness regions disposed below or at the edge of soft tissue).
Regarding claims 2-3, Pulapura 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 (mesh or fibers, paras [0074]-[0075]).
Regarding claims 4-5, Pulapura discloses the scaffold of claim 1, wherein the first material is a synthetic polymer (para [0074]) and wherein the second material is a synthetic polymer (para [0074]).
Regarding claim 6, Pulapura 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 paras [0074]-[0075]).
Regarding claims 7-8, Pulapura discloses the scaffold of claim 1, wherein the first material is a biological material and wherein the second material is a biological material (hemostatic agent or other materials such as fibrin, collagen, paras [0074] and [0093]).
Regarding claim 9, Pulapura 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 para [0093]).
Regarding claim 10, Pulapura discloses the scaffold of claim 9, wherein the first layer is a synthetic polymer and the second layer is a biological material (paras [0074]; [0091]; [0097]-[0099]; layers 28/30 can be made of either polymer or other hemostatic agents, collagen).
Regarding claim 12, Pulapura discloses the scaffold of claim 1, wherein the first or second layer comprises both a synthetic polymer and a biological material (paras [0074]; [0091]; [0093]; [0097]-[0099]; layers 28/30 can be made of either polymer or other hemostatic agents, collagen).
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 Pulapura in view of Crook et al, WO 2022/082259 A1.
Regarding claim 11, Pulapura discloses the scaffold of claim 8, wherein the biological material is collagen (paras [0074] and [0094]), 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 Pulapura 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
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 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
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