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 claims
Claims 1 and 36 are currently amended. Claims 2-35 are original. Claims 1-36 are pending and under examination.
Priority
This application is a 371 of PCT/US2021/030457, filed on May 3, 2021. It claims priority under 35 U.S.C. §119(e) to United States Provisional Application No. 63/019,870, filed on May 4, 2020. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after allowance or after an Office action under Ex Parte Quayle, 25 USPQ 74, 453 O.G. 213 (Comm'r Pat. 1935). Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, prosecution in this application has been reopened pursuant to 37 CFR 1.114. Applicant's submission filed on 04/16/2026 has been entered.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 11/03/2022, 10/31/2024, 02/12/2025, 02/21/2025, 06/17/2025, 11/24/2025, 12/08/2025, 12/17/2025, 12/17/2025, 01/16/2026, 01/27/2026, 04/16/2026 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Rejections - 35 USC § 112 (a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 1-8, 12-28, and 30-36 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for hydrochloric acid, oxalic acid, and sulfuric acid, does not reasonably provide enablement for all acids. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make the invention commensurate in scope with these claims.
As a general rule, enablement must be commensurate with the scope of claim language. MPEP 2164.08 states, “The Federal Circuit has repeatedly held that “the specification must teach those skilled in the art how to make and use the full scope of the claimed invention without undue experimentation’.” In re Wright, 999 F.2d 1557, 1561, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993)” (emphasis added). The “make and use the full scope of the invention without undue experimentation” language was repeated in 2005 in Warner-Lambert Co. v. Teva Pharmaceuticals USA Inc., 75 USPQ2d 1865, and Scripps Research Institute v. Nemerson, 78 USPQ2d 1019 asserts: “A lack of enablement for the full scope of a claim, however, is a legitimate rejection.” The principle was explicitly affirmed most recently in Auto. Tech. Int’l, Inc. v. BMW of N. Am., Inc., 501 F.3d 1274, 84 USPQ2d 1108 (Fed. Cir. 2007), Monsanto Co. v. Syngenta Seeds, Inc., 503 F.3d 1352, 84 U.S.P.Q.2d 1705 (Fed. Cir. 2007), and Sitrick v. Dreamworks, LLC, 516 F.3d 993, 85 USPQ2d 1826 (Fed. Cir. 2008). See also In re Cortright, 49 USPQ2d 1464, 1466 and Bristol-Myers Squibb Co. v. Rhone-Poulenc Rorer Inc., 49 USPQ2d 1370.
The factors to be considered in determining whether a disclosure meets the enablement requirement of 35 U.S.C. 112, first paragraph, have been described in In re Wands, 8 USPQ2d 1400 (Fed. Cir. 1988). Among these factors are: A) Breadth of claims; B) The nature or the invention; C) The state of the prior art; D) The relative skill of those in the art; E) The predictability or unpredictability of the art; F. The amount of direction or guidance presented; F. the presence or absence of working examples; and H. the quantity of experimentation necessary. When the above factors are weighed, it is the examiner’s position that one skilled in the art could not practice the invention without undue experimentation. Some experimentation is not fatal; the issue is whether the amount of experimentation is “undue”; see In re Vaeck, 20 USPQ2d 1438, 1444.
Breadth of claims.
Independent claims 1 and 28 broadly encompass reacting lactate compounds with essentially any “acid” or an “acid compound of formula HnX”, including broad genera of organic acids inorganic acids, mono-, di-, and polyprotic acids, strong acids, weak acids, oxidizing acids, amino acids, and acids having widely varying conjugate bases and solubility characteristics. However, the specifications only demonstrate operability for a limited subset of acids, primarily sulfuric acid, hydrochloric acid, and oxalic acid [specification ¶¶ 23-25, 38-42]. The claims therefore encompass substantial embodiments not demonstrated or reasonably predicted from this disclosure, including acids which may fail to precipitate suitable inorganic salts, may remain soluble in the selected solvent systems, or may introduce competing side reactions incompatible with formation of anhydrous lactic acid. The claims are therefore substantially broader than the enabling disclosure.
Nature of the invention.
The claimed invention contains non-aqueous acid-mediated conversion chemistry, selective precipitation behavior, solvent compatibility, crystallization, azeotropic drying, and purification of anhydrous lactic acid. Such process chemistry is highly dependent on acid strength, conjugate base properties, salt solubility, solvent interaction, and water content. The instant specification itself acknowledges the importance of solvent and acid selection in achieving successful crystallization and purity [specification ¶¶26-35, 47-50]. Accordingly, the invention is not merely routine acid-base neutralization, but rather a sensitive purification and separation process requiring coordinated control of multiple variables.
State of the prior art.
Per Qui et al. (Qiu, Jun, et al. “High-Throughput Salt Screening of Synthetic Intermediates: Effects of Solvents, Counterions, and Counterion Solubility.” Organic Process Research & Development, vol. 24, no. 7, 29 May 2020, pp. 1262–1270, https://doi.org/10.1021/acs.oprd.0c00132. Accessed 4 Mar. 2025.), the prior art confirms that salt-forming and crystallization outcomes are dependent on the acid/counter-ion [abstract, table 4, table 5]. Rather, high-throughput salt-screening data show that crystallization outcomes are largely determined by the selected acids, counter-ion and solvents [abstract, table 4, table 5], reinforcing that the claimed open-ended “acid” /” HnX” genus would require substantial empirical screening across acids and solvent systems. Additionally, the specification itself repeatedly narrows discussion to selected acid systems rather than presenting generalized operability across the full claim scope [applicant specification ¶¶38-42].
Level of ordinary skill in the art.
A person of ordinary skill in the art would be an organic chemist, pharmacologist, medicinal chemist, or inorganic chemist.
Predictability or unpredictability of the art.
The chemical arts, particularly crystallization and purification chemistry, are considered relatively unpredictable. Small variations in acid selection, conjugate-base identity, solvent composition, water content, or crystallization conditions may substantially alter reaction outcomes, precipitation behavior, and impurity formation. The specification itself demonstrates reliance on carefully selected reaction conditions, seed crystals, azeotropic drying, and selected solvent systems to obtain desired purity and crystallization behavior [specification ¶¶31-35, 47-50].
Amount of direction or guidance presented.
Although the specification provides examples using specific acids and solvents, the disclosure does not provide sufficient guidance allowing a skilled artisan to reasonably determine which acids within the full scope of “acids” or “HnX” will successfully operate within the claimed processes without substantial screening and experimentation. The specification lacks any generalized selection criteria based on PKa, salt precipitation behavior, solvent compatibility, water tolerance, or conjugate-base solubility that would permit reliable extrapolation across full claim scope [see specification ¶¶23-26].
Presence or absence of working examples.
The specification provides only a limited number of working examples directed primarily to sulfuric acid, hydrochloric acid, and oxalic acid systems in selected ester solvents [specification ¶¶38-43; examples 1-8]. The specification thus does not provide representative working examples spanning the full breadth of the claimed genus.
Quantity of experimentation necessary.
In view of the breadth of the acid genus, the relative unpredictability of crystallization chemistry, the limited representative examples, and the absence of meaningful guidance for identifying operative acids across the full scope, a skilled artisan would be required to conduct substantial empirical screening and optimization to determine which acids successfully produce the claimed anhydrous lactic acid product under the claimed solvent systems and purification conditions. Such experimentation would constitute undue experimentation.
Due to the above reasons, Claims 1 and 28 are rejected. Claims 2-8, 12-27, and 30-36 are also rejected for being dependent on claims 1 and 28 without properly remedying or narrowing the broad scope of enablement.
Claim Rejections – 35 USC § 112 (b)
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.
Claims 1-27, 33, and 34 are 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 lactic acid compound of formula (I); however, formula (I) includes an undefined variable “n” adjacently positioned to the top left of the methyl group (i.e., nH3C––). The claim further recites that “each n is independently an integer other than 0”, but it is unclear how the variable “n” applies to formula (I), what structural feature it modifies, or how an integer value for “n” affects the identity, valence, or connectivity of the claimed lactic acid compound. As presented, the notion does not clearly correspond to a chemically meaningful substituent, repeating unit, stoichiometric coefficient, or charge-balancing parameter within formula (I). Accordingly, one of ordinary skill in the art would not be able to determine the metes and bounds of the claimed method with reasonable certainty because the structure and scope of the recited lactic compound of formula (I) are unclear, rendering claim 1 indefinite.
Claims 2-27, 33, and 36 are also rendered indefinite for being dependent on independent claim 1.
Claim Objection/Allowable Subject Matter
Claim 29 is objected to as being dependent upon a rejected base claim (i.e., claim 28), but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusions
Claims 1-28, and 30-36 are not allowed. Claim 29 objected to.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ARYA AHMADI BAZARGANI whose telephone number is (571)272-0211. The examiner can normally be reached Monday - Friday 9:00AM - 5:00 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Brian-Yong Kwon can be reached at (571) 272-0581. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Arya A. Bazargani, Ph.D.
Patent Examiner
Art Unit 1613
/MARK V STEVENS/ Primary Examiner, Art Unit 1613
Prosecution Insights