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.
Election/Restrictions
Claim 2 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 09 March 2026.
Applicant’s election of Group I (claim 1) in the reply filed on 09 March 2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
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 1 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.
Claim 1 recites a bending resistance of “10 N” and “5 N.” The Applicant references other bending strength values wherein the bending strength is given in “N/mm2,” that are presumably from the art. Therefore, the metes and bounds of the limitation cannot be determined and it is unclear if the units of instant claim 1 should be provided as Newtons (N) or N/mm2.
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.
Claim(s) 1 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ikada et al. (US 4898186 A).
Ikada teaches an osteosynthesis material made of poly-L-lactic acid (claim 1; entire teaching) to fix bones (col. 1, lns. 5-7), addressing claim 1. In regards to the bending resistance limitations of claim 1, these limitations are considered inherent properties of the composition. In lieu of objective evidence of unexpected results, these inherent properties are interpreted as being present in the composition since Ikada teaches an osteosynthesis material substantially composed of poly-L-lactic acid. It is noted that “products of identical chemical composition cannot have mutually exclusive properties.” A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990) (see MPEP 2112.01 (II)).
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). In regards to the bending resistance limitations of claim 1, these limitations are considered inherent properties of the composition. In lieu of objective evidence of unexpected results, these inherent properties are interpreted as being present in the composition since Ikada teaches an osteosynthesis material substantially composed of poly-L-lactic acid. It is noted that “products of identical chemical composition cannot have mutually exclusive properties.” A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990) (see MPEP 2112.01 (II)).
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.
Conclusion
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/D.A.K./Examiner, Art Unit 1613
/ANDREW S ROSENTHAL/Primary Examiner, Art Unit 1613
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