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 .
Priority
The instant application was filed 08 May 2024 and is the national stage entry for PCT/JP2022/041420 filed 07 November 2022. The Applicant claims priority to foreign application JP2021-183483 filed 10 November 2021. An English copy of the foreign document has not been provided. Therefore, the effective filing date of the instant application is 07 November 2022.
Examiner’s Note
The Applicant's arguments filed 05 August 2026 are acknowledged and have been fully considered. The Examiner has re-weighed all the evidence of record. Rejections
not reiterated from previous Office Actions are hereby withdrawn. The following rejections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application. In the Applicant’s response, filed 05 August 2026, it is noted that no claims have been amended, canceled, or newly added.
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(s) 1 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ikada et al. (US 4898186 A) and Hyon et al. (US 5227412 A).
Regarding claim 1, Ikada teaches an osteosynthesis material made of poly-L-lactic acid (claim 1; entire teaching) to fix bones (col. 1, lns. 5-7).
Furthermore, Ikada teaches bending resistance values (Table 1) and Hyon et al. teach a bending strength of 1.6 x 103 to 2.5 x 103 kg/cm2 for PLA and is mostly maintained at 37°C (col. 2, lns. 35-55), where a skilled artisan would have easily recognized the importance of optimizing the bending strength properties of the material in order to create a better or ideal osteosynthesis material. Bending strength is interpreted similarly to “bending resistance” used in instant claim 1. That being said and in lieu of objective evidence of unexpected results, the limitations regarding the bending resistance can be viewed as a variable that achieves the recognized result of successfully making the poly-L-lactic acid osteosynthesis material, which a skilled artisan would have been easily motivated to modify and adjust based on the broad teachings of Ikada. The optimum or workable range for the bending resistance can be accordingly characterized as routine optimization and experimentation (see MPEP 2144.05 (II)B). “[Discovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art.” In re Boesch, 617 F.2d 272, 276 (CCPA 1980). Applicants provide no evidence of any secondary consideration, such as unexpected results, that would render the optimized values of bending resistance as nonobvious.
Response to Arguments
Applicant's arguments filed 05 August 2026 have been fully considered but they are not persuasive.
The Applicant argues that neither Ikada nor Hyon teach or suggest the bending resistance recited in claim 1 (Remarks, pgs. 7-8). The Applicant refers to Example 1 and Comparative Examples 1-4 showing the alleged differences in the bending resistance properties (Remarks, pg. 8).
Applicant’s argument is not found persuasive. The adjustment of particular conventional working conditions (e.g., determining result effective amounts of the ingredients beneficially taught by the cited references, especially within the broad ranges instantly claimed), is deemed merely a matter of judicious selection and routine optimization which is well within the purview of the skilled artisan. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Accordingly, this type of modification would have been well within the purview of the skilled artisan and no more than an effort to optimize results. Therefore, it would be obvious to adjust the bending resistance to achieve an ideal PLA composition for the intended purpose of fixing bones.
Conclusion
THIS ACTION IS MADE FINAL. 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.
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/D.A.K./Examiner, Art Unit 1613
/ANDREW S ROSENTHAL/Primary Examiner, Art Unit 1613
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