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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 8/7/26 has been entered.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-17 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.
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.
Claims 1, 3, 4, 7, 10, 13 and 17-19 are rejected under 35 U.S.C. 103 as being unpatentable over Swords et al US Patent Pub. 2006/0224242A1 in view of Bravo et al US Patent 9,549,819B1.
Swords et al discloses a method of forming a craniofacial implant (paragraphs 42, 62, 64, 65, 78) for neuroplastic surgery of a patient. The invention comprising determining a size of a bony defect and/or void in a craniofacial region of the patient based on the size of the body defect and/or void of the patient (see paragraph 86 disclosing different areas of the cranium). The implant is pre-manufactured implants (paragraphs 64, 65) of a plurality of pre-determined sizes paragraph 86), selecting an implant formed of a piece of pre-manufactured titanium mesh (paragraphs 64, 65) of a size that covers the bony defect and/or void and at least a portion of the bone surrounding the bony defect and/or void, wherein each of the implants of the plurality of pre-determined sizes is pre-sized to one of a plurality of common craniectomy dimensions (paragraphs 64, 65, 86, 90) and pre-contoured using a common radius of curvature for a human skull; and sterilizing (inherent) the implant. However, Swords et al does not disclose an implant having a single common radius of curvature.
Bravo discloses a titanium mesh comprising a single radius of curvature capable of being attached to the frontal part of the cranium for the purpose of conforming with the average frontal geometry of the region of the skull (See col. 9, lines 19-21; col. 11, lines 48-60).
It would have been obvious to one ordinary skill in the art to have the whole implant having a single radius of curvature in order to conform with the average frontal geometry of the region of the skull.
Regarding the phrase: “single common radius of curvature” (emphasis in common), Swords et al or Bravo et al are silent with respect that the plurality of pre-determined sizes of implants have a single common radius of curvature.
As disclosed in paragraph 77 of the Swords et al reference it is well known in the art to provide the same implant in various sizes which can help reduce waste and time. Therefore, it would have been obvious to one ordinary skill in the art to have the same implant with the same single radius of curvature as disclosed by the Bravo et al reference by only changing the size of the implant (keeping the same radius) in order to reduce waste and time.
Regarding claims 3, 4 and 17, see Fig. 14A showing a polymeric coating covering part of the titanium mesh.
Regarding claim 7, see paragraph 72 disclosing the countersink hole.
Regarding claim 10, see paragraph 65 disclosing a rounded implant.
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Swords et al US Patent Pub. 2006/0224242A1 in view of Bravo et al US Patent 9,549,819B1, and further in view of Mizukami US Patent Pub. 2018/0271657A1.
Swords et al in view of Bravo et al disclose the invention substantially as claimed. However, Swords et al and Bravo et al do not disclose a polished mesh.
Mizakami teaches a titanium mesh disclosing the step of polishing the edges of the mesh for the purpose of having a smooth surface and suppress the irritation of tissue.
It would have been obvious to one having ordinary skill in the art to polish the surface and edges of the titanium mesh of the Swords et al reference in order to have a smooth surface and suppress the irritation of tissue.
Claims 5, 6, 8, 9, 11, and 14-16 are rejected under 35 U.S.C. 103 as being unpatentable over Swords et al US Patent Pub. 2006/0224242A1 in view of Bravo et al US Patent 9,549,819B1, and further in view of Gordon US Patent Pub. 2018/0338835A1.
Swords et al in view of Bravo et al disclose that during the manufacturing process the implant can be shaped to a specific configuration by putting the implant in a mold. However, Swords et al and Bravo et al do not disclose a manufacturing step of molding the implant by hand based on a stereolithographic model.
Swords et al discloses a malleable implant that can be shaped by hand, however, Swords et al does not disclose a stereolithographic model.
It would have been obvious to one ordinary skill in the art to manufacture the Swords et al implant based on a stereolithographic model and using a 3D printer, since, it is well known in the art to use these manufacturing processes.
Regarding claims 8 and 9, see paragraph 28 of the Gordon reference disclosing a pre-operative scan of the targeted area for the purpose of designing an implant.
Regarding the pre-determined sizes in claims 11 and 14-16, discloses the claimed invention except for specific implant sizes. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the sizes of the implant, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Allowable Subject Matter
Claim 12 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALVIN J STEWART whose telephone number is (571)272-4760. The examiner can normally be reached Monday-Friday 8:30AM-6PM EST.
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/ALVIN J STEWART/Primary Examiner, Art Unit 3799 8/14/26
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