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
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 1 is rejected under 35 U.S.C. 103 as being unpatentable over Gordon et al. US 2016/0081805 (hereafter referred to as Gordon) in view of Shim KR 2016/0053522 (hereafter referred to as Shim; cited in IDS; refer to the attached translation for passages referenced herein).
Regarding Claim 1, Gordon discloses a three-dimensional implant (300) manufactured based on an image on a defect area of a skull (200) (par.79), the image being generated based on a computed tomography on the skull (200) of a patient (par.79), the three-dimensional implant (300) comprises a body portion (340) having a shape substantially the same as the defect area of the skull (200), an extended portion (360) disposed at a front of the body portion (340), capable of being fixed to a zygomaticofrontal suture of the patient (the extended portion 360 is capable of being attached both directly and via any interfering structure to a zygomaticofrontal suture of the patient; the limitation is directed to the intended use of the implant and the implant of Gordon is capable of being used, positioned, and fixed as claimed), and having a thickness larger than that of the body portion (par.57, lines 4 and 5; compare the implant thickness shown in fig.7B with fig.7F and compare the implant thickness shown in fig.8B with fig.8F wherein these figures show a thicker augment/extended portion), and a plurality of fixing portions (considered the plates disclosed in par.56) protruded along an outline of the body portion (340) and capable of being fixed with the skull (200) (par.56), wherein a surface of the extended portion (360) is protruded, so that a position of the surface of the extended portion (360) is capable of being maintained to be on the same plane as a protruded position of zygomatic bone of the patient (this limitation is interpreted to mean that the extended portion contains a surface that is curved outwards in a specific way to match the native anatomy of the skull which Gordon teaches in par.56 lines 1-3, par.57 lines 4-6, and figs. 2 and 3B; further, the implant of Gordon is capable of being implanted such that a surface of the extended portion lies on the same plane as a protruded position of zygomatic bone of the patient), and wherein the extended portion (360) is capable of being inserted between a superficial temporalis muscle of the patient and a deep temporalis muscle of the patient (this limitation is directed to the intended use of the implant; due to its approximate size and disclosed orientation on the skull (figs. 2 and 4A), the implant described in Gordon is capable of being inserted between a superficial temporalis muscle and a deep temporalis muscle of the patient as claimed). Gordon further discloses the body portion and extended portion are integrally formed with each other (fig.3B). Gordon discloses the invention substantially as claimed, but Gordon does not disclose that the fixing portions/plates are integrally formed with the body portion and extended portion, or that each of the body portion, the extended portion, and the plurality of fixing portions comprises titanium and has a honeycomb structure.
Shim teaches a cranial implant, in the same field of endeavor, wherein fixing portions 120 extend from a body portion 110 of the implant 100 to secure the implant to bone (fig.5), wherein the fixing portions are integrally formed with the body portion of the implant by a 3D printer (fig.5; pg.4, par.8 states the implant is manufactured to include a unit 120 therefore since the implant is made by a 3D printer they are integrally formed), and wherein the implant is made of titanium (pg.5, par.2) and has a honeycomb structure (pg.4, pars.4-7). The body portion and fixing portions of the implant are integrally formed by 3D printer for the purpose of simplifying the implant manufacturing process (pg.5, par.1). The implant is made of titanium for the purpose of minimizing the body’s immune reaction and preventing infection (pg.5, par.2). The implant has a honeycomb structure for the purpose of producing a lighter implant, reducing material costs, and allowing tissue to grow (pg.4, pars.4-7).
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 separate fixing portions/plates of Gordon to be integrally formed with the implant by 3D printing as taught by Shim in order to simplify the manufacturing process. It would have been further obvious to modify the separate fixing portions of Gordon to be integrally formed with the body portion and extending portion since it has been held that the use of a one piece construction instead of several parts would be merely a matter of obvious engineering choice (In re Larson, 340 F.2d 965, 968, 144 USPQ 347, 349 (CCPA 1965) MPEP 2144.04 V B). It would have been further obvious to select titanium and a honeycomb structure for the material of all implant parts of Gordon in order to minimize the body’s immune reaction and prevent infection, produce a lighter implant, reduce material costs, and allow tissue to grow as taught by Shim. It would have been further obvious to select the titanium material and honeycomb structure taught by Shim for the implant material of Gordon since it has been held that selection of a known material based on its suitability for an intended use is an obvious extension of prior art teaching (In re Leshin 227 F.2d 197, 125 USPQ 416 (CCPA 1960) MPEP 2144.07).
Response to Arguments
Applicant's arguments filed 9/10/2025 have been fully considered. The amendments to claim 1 have necessitated the new ground of rejection. However, since Gordon is still applied, arguments relevant to Gordon are addressed herein. Applicant argues the examiner’s rationale relies on combining Gordon’s PMMA-based patient specific implant with a teaching of a titanium porous implant, but a skilled artisan would not be motivated to replace Gordon’s PMMA with titanium honeycomb as such modification fundamentally alters Gordon’s approach and is unsupported by the references. This is not persuasive because while Gordon discloses PMMA as a material for the implant, Gordon does not teach away from the use of other materials including titanium. Titanium is a common implant material and Shim is directed to a titanium implant having a honeycomb structure which provides the many advantages listed above in the rejection of claim 1. Therefore, since both references are directed to implants based on an image on a defect area of a skull, they are in the same field of endeavor, and a skilled artisan would be motivated to modify the material of Gordon to the claimed material for the benefits highlighted in Shim as discussed above.
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 MEGAN Y WOLF whose telephone number is (571)270-3071. The examiner can normally be reached Mon-Fri 8am-2pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melanie Tyson can be reached at (571)272-9062. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MEGAN Y WOLF/Primary Examiner, Art Unit 3774