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. Claim Rejections - 35 USC § 112 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. Claims 1- 11 rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention. The claims broadly encompass methods for crystallizing hydroxyalkanoic acids and crystalline forms thereof. However, the specification provides detailed crystallization conditions only for 3-hydroxybutyric acid, as described in Examples 1–4, and does not provide sufficient guidance for crystallizing other hydroxyalkanoic acids within the scope of the claims. Crystallization and purification of organic compounds are highly sensitive to process parameters, including temperature, pressure, solvent selection, and crystallization technique. As such, significant variation in conditions is often required to obtain crystalline products for different compounds. In determining whether the disclosure enables the full scope of the claimed invention without undue experimentation, the factors set forth in In re Wands, 858 F.2d 731, 737 (Fed. Cir. 1988) must be considered. These factors include the breadth of the claims, the amount of guidance provided in the specification, the presence or absence of working examples, and the quantity of experimentation required. Here, the claims cover a broad genus of hydroxyalkanoic acids, while the specification provides working examples and guidance only for a single species. A person of ordinary skill in the art would therefore be required to engage in undue experimentation to determine suitable crystallization conditions and crystalline forms for other hydroxyalkanoic acids encompassed by the claims. Claims 1- 11 rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. The claims are directed to a method for obtaining solid crystals of hydroxyalkanoic acids in high yield, and to crystalline forms thereof. To satisfy the written description requirement, the specification must reasonably convey to a person of ordinary skill in the art that the inventor had possession of the claimed subject matter as of the filing date. In the present application, the specification describes crystallization methods only for 3-hydroxybutyric acid, as set forth in Examples 1–4. The specification does not describe crystallization methods applicable to other hydroxyalkanoic acids encompassed by the claims, nor does it demonstrate possession of methods capable of producing solid crystals of such acids in high yield. Further, claims 5–7 define crystalline forms by numerical powder X-ray diffraction parameters that are specific to 3-hydroxybutyric acid. The specification does not describe or exemplify corresponding crystalline forms for other hydroxyalkanoic acids within the scope of the claims. Accordingly, the specification does not provide adequate written description support for the full scope of claims 1– 11 . 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) 1-4 , 8-11 is/are rejected under 35 U.S.C. 103 as being unpatentable over JP 2004-509092A (hereafter JP’092) or JP S61-205229 (hereafter JP’229) in view of JP S57-026613A (hereafter JP’613) or JP H09-510862A (hereafter JP’862) or JP 2007-536275A (hereafter JP’275) or WO 2016/088863 (hereafter WO’863) . JP’092 and JP’229 disclose methods for crystallizing hydroxycarboxylic acids ( JP’092 , claims 1–12; JP’229 , claim scope and Embodiment 1), but do not expressly disclose crystallization by freeze-drying. JP’613 or JP’862 or JP’275 or WO’863 disclose that freeze-drying is a known and effective technique for crystallizing organic compounds ( JP’613 , claim scope and Embodiment 1; JP’862 , claims 4 and Embodiment 4; JP’275 , claims 32–33 and paragraph [0048]; WO’863 , claims 6–8 and Embodiment 1). A person of ordinary skill in the art would have been motivated to apply freeze-drying, as taught in JP’613 or JP’862 or JP’275 or WO’863 , to the crystallization methods for hydroxycarboxylic acids disclosed in JP’092 or JP’229 in order to obtain solid crystals with improved handling properties, storage stability, and reproducibility. Freeze-drying is a known crystallization and solidification technique for organic compounds, and its application to hydroxycarboxylic acids would have represented the use of a known technique to improve a similar process involving a closely related class of compounds. The substitution of freeze-drying for conventional crystallization methods would have been a predictable modification yielding no more than expected results. Further, the specification does not demonstrate that crystallizing hydroxyalkanoic acids by freeze-drying produces any unexpected or particularly superior effect. Claim (s) 5-7 is/are rejected under 35 U.S.C. 103 as being unpatentable over JP 2004-509092A (hereafter JP’092) or JP S61-205229 (hereafter JP’229) in view of JP S57-026613A (hereafter JP’613) or JP H09-510862A (hereafter JP’862) or JP 2007-536275A (hereafter JP’275) or WO 2016/088863 (hereafter WO’863) . Claims 5–7 differ from the disclosures of JP’092 or JP’229 or JP’613 or JP’862 or JP’275 or WO’863 in that the hydroxyalkanoic acids are defined by specific diffraction peaks in a powder X-ray diffraction pattern. It is well known in the art that organic compounds are routinely crystallized to obtain solid forms having improved stability, storage stability, and ease of handling. JP’092 or JP’229 or JP’613 or JP’862 or JP’275 or WO’863 collectively disclose multiple crystallization techniques applicable to organic compounds, including freeze-drying ( JP’613 , claim scope and Embodiment 1; JP’862 , c laim 4 and Embodiment 4; JP’275 , claims 32–33 and paragraph [0048]; WO’863 , claims 6–8 and Embodiment 1). A person of ordinary skill in the art would have been motivated to apply these known crystallization techniques to hydroxyalkanoic acids disclosed in Cited Documents 1 and 2 in order to obtain stable crystalline forms. The resulting crystalline polymorphs, characterized by powder X-ray diffraction peaks, would have been the predictable result of routine crystallization and solid-form screening. The specification does not establish that the claimed crystalline forms exhibit any unexpected or particularly advantageous properties. Any inquiry concerning this communication or earlier communications from the examiner should be directed to FILLIN "Examiner name" \* MERGEFORMAT DEBORAH D CARR whose telephone number is FILLIN "Phone number" \* MERGEFORMAT (571)272-0637 . The examiner can normally be reached FILLIN "Work Schedule?" \* MERGEFORMAT Monday-Friday (10:30 am -7:00 pm) . Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. 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If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /DEBORAH D CARR/ Primary Examiner, Art Unit 1691