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 .
Status of the Claims
Claims 1 – 21 are pending.
Claims 1 – 16 and 18 are rejected.
Claims 17 and 19 – 21 are withdrawn.
Election/ Restriction
Applicant’s election without traverse of Group I (claims 1 – 16 and 18) in the reply filed on July 6, 2026 is acknowledged. Further, Applicant has specifically elected (a) acetone, a ketone of formula R1-C(=O)-R2, wherein R1 and R2 are methyl; and (b) diisopropyl ether, an ether of formula R3-O-R4, wherein R3 and R4 are isopropyl.
Examination: Claims 1 – 16 and 18 read on the elected species. The elected species of acetone or diisopropyl ether are allowable over the prior art. In accordance with MPEP §803.02, the search has been extended to the complete scope of the claims. Claims 17 and 19 – 21 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected inventions, there being no allowable generic or linking claim.
Priority
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Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on May 14, 2024, July 6, 2026, August 31, 2026 and September 2, 2026 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement are being considered by the examiner.
Claim Objections
Claims 1, 3, 9 and 16 are objected to because of the following informalities:
Claim 1, lines 5-8 of the claim: The limitation “… at least one compound selected from the group of ketones of the formula… t-butyl, and isobutyl and ethers of the formula…” is grammatically incorrect because it does not recite proper punctuation (comma (,)) and Markush group language for the group of alternatives. In order to overcome the objection, Applicant may amend the limitation as follows: “… at least one compound selected from the group consisting of ketones of the formula… t-butyl, and isobutyl, and ethers of the formula…”. Emphasis added.
Claim 1, lines 13-14 of the claim: The limitation “wherein the solid meso lactide recovered from a final step of solvent crystallisation followed by recovery of product meso-lactide has a free acid content…” is too wordy and difficult to interpret. In order to overcome the objection, Applicant may amend the limitation as follows: “wherein said solid form of meso lactide
Claim 3, page 3, lines 2-3 of the claim: The use of the term “for” in the limitation “… the solvent crystallisation step is carried in a solvent consisting for at least 80 wt….” is improper. Emphasis added. In order to overcome the objection, Applicant may amend to replace the term “for” with the term “of”.
Claim 9, page 5, line 2: The claim is incomplete because a period (.) is missing at the end of the claim. In order to overcome the objection, Applicant may recite a period after the term “meso-lactide”.
Claim 16, lines 2-3 of the claim: The limitation “wherein solid meso-lactide recovered from a step of solvent crystallisation followed by recovery of product is subjected to a washing…” is too wordy and difficult to interpret. In order to overcome the objection, Applicant may amend the limitation as follows: “wherein said solid form of meso-lactide.
Appropriate correction is required.
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.
Claims 1 – 16 and 18 are rejected under 35 U.S.C. 112(b) as being incomplete for omitting essential steps, such omission amounting to a gap between the steps. See MPEP § 2172.01.
Claim 1 is directed to a process for purifying meso-lactide which has a free acid content of at least 30 meq/kg comprising at least one step of subjecting a feed comprising at least 75 wt.% meso-lactide to solvent crystallisation followed by recovery of product meso-lactide, wherein the solvent crystallisation step is carried in a solvent comprising a total of at least 70 wt.% of at least one compound selected from the group consisting of ketones and ethers. The solvent crystallisation conditions are selected such that at least 15% of the meso-lactide in the feed crystallises in solid form. Emphasis added. The instant specification discloses (see, e.g., Examples 2-5) the reaction conditions, such as solvent(s), crystallisation temperature and end temperature) necessary to perform solvent crystallisation. However, the instant claims do not further define any limitations for the required conditions (e.g., temperature, concentrations of the starting materials, solvents and/or reactants) associated with solvent crystallisation. The omission of essential steps would lead to a gap such that a person having ordinary skill in the art would be unable to discern proper conditions needed for solvent crystallisation such that at least 15 % of the meso-lactide in the feed crystallises in solid form. Therefore, the claims are considered incomplete.
In order to overcome the rejection, Applicant may amend claim 1 to incorporate specific limitations of solvent crystallisation conditions (see, e.g., dependent claims 3, 7 and 12 – 13) that would provide essential steps to perform solvent crystallisation and purify meso-lactide.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Sagar Patel whose telephone number is (571)272-1317. The examiner can normally be reached Monday - Friday: 9am to 5pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amy L. Clark can be reached at (571) 272-1310. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Sagar Patel/Examiner, Art Unit 1626
/KAMAL A SAEED/Primary Examiner, Art Unit 1626
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