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 claims 1-4, 7-13, and 16-19 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 1-4, 7-13, and 16-19 are rejected under 35 U.S.C. 103 as being unpatentable over Kuhn et al US Patent Pub. 2022/0202574 A1 in view of Koizumi et al US Patent Pub. 2016/0183990A1.
NOTE: Some of the claims disclose functional limitations of the implantable product. For example, some claims are describing what the implant is replacing and the location of the implant. Additionally, some other claims are disclosing which specific bone is replacing and the product by process of the implant, such as, manufactured by 3-D printing. Even if the Examiner is giving patentable weight to those limitations, the Examiner just wants to point out that the Examiner is just required to find a reference capable of performing those tasks.
Regarding claims 1 and 12, Kuhn et al discloses a device (37, see Fig. 10) intended for guided bone regeneration (see paragraph 194 disclosing a hydroxyapatite) which comprises at least one covering plate (43) whose shape permits the recreation of a bone's surface as the bone's surface was prior to the appearance of a bone defect by covering said bone defect while resting (capable, see paragraph 71), at least partially, on the healthy bone surrounding said bone defect (capable of), wherein said covering plate is made of grade 1 or grade 2 titanium (see tables 1 and 2 in paragraph 98). However, Kuhn et al is silent regarding having micro-perforations the size between 50 to 100 microns.
Koizumi et al discloses an implant (60) having a plurality of micro-perforations with different sizes. On paragraph 107, discloses an embodiment having second pores with a diameter between 80 to 220 microns to allow passage of blood vessels and supplying tissue regions with nutrients.
It would have been obvious to one ordinary skill in the art to modify the Kuhn et al reference with the plurality of micro-perforations between the sizes of 80 to 100 microns of the Koizumi et al reference in order to allow passage of blood vessels and supplying tissue regions with nutrients.
Regarding claim 2, see paragraph 106 (Kuhn et al).
Regarding claim 3, see table 1 in paragraph 98 showing different embodiments having a structure thickness between 0.3mm to 1mm (Kuhn et al).
Regarding claims 4 and 13, a comparison of the recited process with the prior art processes does NOT serve to resolve the issue concerning patentability of the product. In re Fessman, 489 F2d 742, 180 U.S.P.Q. 324 (CCPA 1974). Whether a product is patentable depends on whether it is known in the art or it is obvious, and is not governed by whether the process by which it is made is patentable. In re Klug, 333 F2d 905, 142 U.S.P.Q. 161 (CCPA 1964). In an ex parte case, product-by-process claims are not construed as being limited to the product formed by the specific process recited. In re Hirao et al., 535 F2d 67, 190 U.S.P.Q. 15, see footnote 3 (CCPA 1976). However, see paragraphs 190 and 198 disclosing the 3-D printing process.
Regarding claims 7 and 16, see Fig. 10 (Kuhn et al) and paragraph 204 showing and disclosing the solid material at the circumferential periphery of the plate.
Regarding claims 8-9 and 17-18, even though the specification does not mention the width of the solid material, it is clearly disclosed in Fig. 10 (Kuhn et al) that the width (element 45) of the solid material is very similar to the thickness of the plate, therefore, as disclosed in the different embodiments shown in Table 1 having foam thickness between 1mm and 3.2mm we can get from these measurements that the width of the solid material is approximately between 1mm to 3mm falling between the claimed range.
Regarding claim 10, see paragraph 202, lines 5-6 (Kuhn et al).
Regarding claims 11 and 19, since the Examiner is not clear what does the Applicant’s representative is claiming, the Examiner is interpreting the “the at least one drilling” as a hole used with the screw in order to attach the implant to the targeted bone area.
Kuhn et al discloses the invention substantially as claimed. However, Kuhn et al does not disclose a range of pores sizes between 50 to 100 microns.
It would have been obvious to one having ordinary skill in the art at the time the invention was made to reduce the diameter of the pore sizes between 50 to 100 microns, 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 9/4/26
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