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 .
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) 1-8 is/are rejected under 35 U.S.C. 103 as being unpatentable over CA2958544 in view of WO2016/200201 (English machine translation provided herewith).
Regarding claim 1, WO98/46164 teaches:
1. A method of forming a scaffold implant (CA2958544: pg 17:15-pg 19:12; example 1) comprising:
providing a mold comprising a shape and a size representing an implant (CA2958544: pg. 14:23-pg 17:4; example 1);
heating a biocompatible polymer sheet to a first temperature (CA2958544: pg. 14:23-pg 17:4; example 1; the P4HB thermoformable sheet is biocompatible);
contacting the biocompatible polymer sheet that was heated to the mold (CA2958544: pg. 14:23-pg 17:4; example 1; the preheated P4HB thermoformable sheet contacts the mold);
applying a vacuum to the biocompatible polymer sheet that was heated to draw the biocompatible polymer sheet over the mold (CA2958544: pg. 14:23-pg 17:4; example 1; the preheated P4HB thermoformable sheet is vacuum formed again the mold); and
cooling the biocompatible polymer sheet, that was drawn over the mold, below the first temperature to fix the shape representing the implant in the biocompatible polymer sheet (CA2958544: pg. 14:23-pg 17:4; example 1; the vacuum formed P4HB thermoformable sheet is cooled so it can be safely removed from the mold),
removing the biocompatible polymer sheet that was drawn over the mold and cooled from the mold (CA2958544: pg. 14:23-pg 17:4; example 1; the vacuumed formed P4HB thermoformable sheet is removed from the mold and then trimmed); and
trimming excess biocompatible polymer sheet to form the scaffold implant (CA2958544: pg. 14:23-pg 17:4; example 1; the vacuumed formed P4HB thermoformable sheet is removed from the mold and then trimmed).
However, CA2958544 does not teach forming an auricular scaffold. WO2016/200201 teaches forming an ear scaffold by various molding methods including vacuum forming (from the English machine translation of WO2016/200201: “According to one embodiment of the present application, the plastic molding method may be at least one of compression molding, transfer molding, injection molding, extrusion molding, laminated molding, blow molding, vacuum molding and rotational molding, but various molding methods are not limited thereto. Can be implemented. For example, a number of holes are made in a pre-made mold, and a nozzle of an extrusion cylinder is fixed to each hole as in plastic injection, and then a biocompatible material in a dissolved state is injected into the mold to respond to the 3D modeling data with the biocompatible material. You can also make ears.”) Since both CA2958544 and WO2016/200201 are analogous with respect to molding scaffold implants, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to form an ear/auricular scaffold as suggested by WO2016/200201 by the vacuum forming process of CA2958544 in order to facilitate the molding of an auricular scaffold.
Regarding claim 2, such is taught by the above combination of CA2958544 and WO2016/200201 since WO2016/200201 teaches printing by additive manufacturing an ear mold from data collected from a 3D scan of an ear (English machine translation including the abstract).
Regarding claim 3, such is taught by the above combination of CA2958544 and WO2016/200201 since WO2016/200201 teaches printing by additive manufacturing an ear mold from data collected from a 3D scan of an ear (English machine translation including the abstract).
Regarding claim 4, the combination of CA2958544 and WO2016/200201 do not teach the claimed type of additive manufacturing. The use of a specific type of additive manufacturing is a mere obvious matter of choice dependent on the desired final product and equipment availability. Since the claimed types of additive manufacturing are well-known in the additive manufacturing art, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to use one of the claimed types in the additive manufacturing of WO98/46164 (modified) in order to efficiently produce high quality auricular scaffolds.
Regarding claim 5, such is taught by CA2958544 (CA2958544: pg. 14:23-pg 17:4; example 1; the P4HB thermoformable sheet is biocompatible).
Regarding claim 6, such is taught by CA2958544 (CA2958544: example 1; the P4HB thermoformable sheet has a thickness of 1.56mm)
Regarding claim 7, CA2958544 does not teach the sheet having a plurality of holes with the claimed diameter. Since scaffold implants having holes with the claimed diameter are well-known in the implanting art for its effectiveness, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to design the film of CA2958544 with holes having the claimed diameter in order to facilitate tissue or other materials anchoring to the scaffold implant.
Regarding claim 8, CA2958544 does not teach packing the scaffold with crushed cartilage to form an auricular graft. Since packing crushed cartilage against a scaffold implant to form a graft is well-known and conventional in the auricular graft art, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to efficiently and effectively form an auricular graft by packing the scaffold implant of CA2958544 (modified) with crush cartilage.
Applicant’s arguments with respect to claim(s) 1-8 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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 EDMUND H LEE whose telephone number is (571)272-1204. The examiner can normally be reached M-Th 9AM-4PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Xiao (Sam) Zhao can be reached at 571-270-5343. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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EHL
/EDMUND H LEE/Primary Examiner, Art Unit 1744