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 .
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 § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 5 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
The Examiner was not able to find in the specification that the implant is hand molded during the manufacturing process. Paragraphs 24 and 29, disclose that the implant can be hand-bent pre-operatively (paragraph 24) and hand-bent to a stereolithographic model, but nowhere in the specification discloses that the molding by hand of the implant is performed in the pre-manufacturing process. Correction is required.
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, 3, 4, 7, 10, 13 and 17-19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Swords et al US Patent Pub. 2006/0224242A1.
Regarding claims 1, 13, 18 and 19, 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.
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.
Claims 1 and 12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Engstrand et al US Patent Pub. 2014/0228969A1.
Engstrand et al discloses a method of forming a craniofacial implant (400, see Figs. 4 and 10) 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 (inherent).
The implant is pre-manufactured implants (see paragraph 27, plurality of implant sections) of a plurality of pre-determined sizes, selecting an implant formed of a piece of pre-manufactured titanium mesh (paragraph 30) 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 and pre-contoured using a common radius of curvature for a human skull (see paragraph 27; and sterilizing (inherent) the implant.
Regarding claim 12, see paragraphs 27 disclosing a plurality of implant sections coupled to one another and paragraph 32 disclosing a kit having two or more implant sections that may be selected and coupled together.
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.
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 Mizukami US Patent Pub. 2018/0271657A1.
Swords et al discloses the invention substantially as claimed. However, Swords et al does 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 Gordon US Patent Pub. 2018/0338835A1.
Swords et al discloses 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 does not disclose does 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.
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 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 2/12/26