6DETAILED 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
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed on November 30, 2023.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on April 01, 2035 has been considered by the examiner.
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 1-5, 7-9, 11 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over US 2006/0142505 (Umemoto) in view of US 2006/0247340 (Sato).
Umemoto discloses a composition comprising:
a high-molecular weight aliphatic polyester having a weight-average (Mw) of 120,000 to 1,000,000 such as the exemplified polylactic acid having a Mw of 215,000 [0071] (meets Applicants’ polylactide resin);
a low-molecular weight aliphatic polyester having a Mw of 5,000 to 35,000 such as the exemplified polylactic acid having a Mw of 6,900 [0071].which serves to improve the crystallization rate of the high molecular weight aliphatic polyester [0020] (meets Applicants’ second nucleating agent compound containing a lactide oligomer structure); and
a crystal nucleating agent such as talc [0045]/[0050], wherein the compounding ratio of the low-molecular weight aliphatic polyester to the high-molecular weight aliphatic polyester is preferably 10:90 to 90:10 [0014] (overlaps presently claimed second nucleating agent content) (e.g., abstract, [0016-0018], [0020], [0046-0050], examples, claims).
Umemoto discloses [0066]/[0073] treating the composition at a temperature of about 30 to 160°C for up to 30 minutes (overlaps Applicants’ “heat-treated at 25 to 120°C for 1 to 30 minutes” product-by-process limitation).
In Example 15, Umemoto expressly sets forth a composition, heat treated at 70°C for 2 minutes per Table 4, comprising
50 pbw high-molecular weight polylactic acid (meets Applicants’ polylactide resin);
50 pbw low-molecular weight polylactic acid (meets Applicants’ second nucleating agent compound containing a lactide oligomer structure);
1 pbw ethylene bis-12-hydroxystearamide (EBHSA); and
1 pbw talc, wherein the composition comprises 49 wt.% (50/102) of the low-molecular weight polylactic acid and 0.98 wt.% (1/102) of the talc.
In essence, Umemoto’s Example 15 differs from claim 1 in that the exemplified 49 wt.% low-molecular polylactic acid amount exceeds the 3 to 25 wt.% presently claimed and in that talc, not uracil or orotic acid, is used as a nucleating agent. With respect to the first difference, Umemoto discloses the low-Mw polylactic acid and high- Mw polylactic acid are preferably compounded in a 10:90 to 90:10 weight ratio [0014], i.e., rendering obvious a low-Mw polylactic acid content of up to 25 wt.% for its expected additive effect. Thus, absent evidence of unusual or unexpected results for the presently claimed amounts, no patentability can be seen therein. Typically, differences in concentrations do not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating criticality for the claimed ranges. “Where 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, 105 USPQ 233. As to the second difference, Sato discloses a polylactic acid composition having an uracil nucleating agent has an increased crystallization temperature as compared to a polylactic acid composition having a talc nucleating agent (e.g., Table 3, [0285-0287]). Thus, it would have been obvious to one having ordinary skill in the art to use an uracil nucleating agent (meets Applicants’ first nucleating agent uracil) in place of Umemoto’s talc nucleating agent for its expected additive effect and with the reasonable expectation of success. The resulting composition, being crystallized at temperatures of about 30 to 120°C for up to 30 minutes, would be expected to be the same as Applicants’ composition which is “heat-treated at 25 to 120°C for 1 to 30 minutes”.
As to claim 2, Umemoto discloses [0066] crystallizing the composition at a temperature of about 30 to 160°C, thus rendering obvious the presently claimed composition heat treated at 90 to 110°C.
As to claim 3, Umemoto discloses [0066] crystallizing the composition for up to 30 minutes, thus rendering obvious the presently claimed composition heat treated for 3 to 5 minutes.
As to claim 4, Umemoto discloses the composition has a “high crystallinity” [0021] as evidenced by an exothermal heat flow ΔH of 40 J/g or higher [0090]. It would be expected that Umemoto’s above-modified compositions containing uracil would also be governed by high crystallinity. Thus, absent evidence of unusual or unexpected results for the presently claimed crystallinity degree, no patentability can be seen therein.
As to claim 5, Umemoto discloses a high-Mw polylactic acid having a Mw of 120,000 to 1,000,000 and expressly exemplifies polylactic acid with a Mw of 215,000 [0071].
As to claim 7, Umemoto’s Example 15 uses 0.98 wt.% talc and Sato discloses uracil nucleating agent amounts of 0.001 to 10 pbw per 100 pbw of polylactic acid [0094], rendering obvious the presently claimed amounts for their expected additive effect.
As to claim 8, Umemoto’s low-Mw polylactic acid meets the presently claimed Chemical Formula 1 wherein n1 and n define a Mw of 5,000 to 35,000.
As to claim 9,Umemoto discloses a low-Mw polylactic acid having a Mw of 5,000 to 35,000 and expressly exemplifies a polylactic acid with a Mw of 6,900 [0071].
As to claim 11, Umemoto discloses the low-Mw polylactic acid and high- Mw polylactic acid are preferably compounded in a 10:90 to 90:10 weight ratio [0014], thus rendering obvious low-Mw polylactic acid amounts of up to 21 wt.% for its expected additive effect.
As to claim 12, Umemoto discloses a method for preparing the composition comprising mixing the components (meets Applicants’ step 1) and treating the composition to a temperature of about 30 to 160°C for up to 30 minutes (overlaps Applicants’ step 2). Thus, it would have been within the purview of one having ordinary skill in the art to prepare Umemoto’s above-modified composition comprising the uracil nucleating agent per Sato at a temperature of 80 to 120°C for up to 10 minutes with the reasonable expectation of success.
Response to Arguments
Applicants’ arguments filed August 06, 2026 have been fully considered but they are not persuasive in overcoming the 35 USC 103 rejection over US 2006/0142505 (Umemoto) in view of US 2006/0247340 (Sato).
Applicants’ arguments that the examples of Umemoto use a talc content which is less than the presently claimed first nucleating agent 0.1 wt.% lower limit is not well taken. As noted above, Umemoto’s Example 15 comprises 0.98 wt.% (1/102) talc. Moreover, contrary to Applicants’ contention, Sato discloses uracil nucleating agent amounts of 0.001 to 10 pbw per 100 pbw of polylactic acid [0094]. Thus, it would have been within the purview of one having ordinary skill in the art to use an uracil nucleating agent in amounts as presently claimed for its expected additive effect and with the reasonable expectation of success. It is maintained that the combination of Umemoto and Saito provides sufficient motivation to arrive at the presently claimed subject matter.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Ana L Woodward whose telephone number is (571)272-1082. The examiner can normally be reached M-F 8am-5pm.
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/ANA L. WOODWARD/Primary Examiner, Art Unit 1765
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