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 Application Claims 1-11 , 13-14, 16-17, 19-23 are pending and under current examination. 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. Claims 1-11 , 13-14, 16-17, 19-23 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 pre-AIA the applicant regards as the invention. Claims 1-11 , 13-14, 16-17, 19-23 are indefinite as : Claim 1 recites objective as “preparing mixed oxybate salt” and then recites “mixing at least one oxybate --- mixed oxybate salt comprises at least one---”. This is because a mixed oxybate salt cannot be made by mixing one oxybate salt and mixed oxybate salt cannot contain just one oxybate salt. The claim is further unclear as to the % of oxybate salts. If the mixed oxybate salt contains only one oxybate salt, why there are different % of salts or the limitation is only valid when all the salts are present . Thus, the scope of the claim is unclear. For compact prosecution, the claim has been interpreted as one salt or combination of more than one salt, i.e., and getting one salt or more than one salt in any %. Since the dependent claims doesn’t cure the above deficiency, these claims are also indefinite. Claim 2 is indefinite as the claim recites “alcohols and glycols, methanol, ethanol--- ”, which reflects the use of broad and narrow limitations within the same claim. Claim 7 is indefinite as the claim recites water, preferably purified water”, which reflects the use of broad and narrow limitations within the same claim. Claims 8-11, 13-14 , 16-17, 19-21 are indefinite as the claim recites individual method of making oxybate salts using process steps different from the instant claim 1 and temperature outside the scope of claim 1. If these are further steps of the process then claim needs to recite it. If these are overlapping steps with claim 1, then claim needs to make it clear what steps are overlapping. Thus, scope of claim is unclear. Claims are further unclear with respect to the solvent as these claims recites “a solvent”. Is the solvent used in these claims is same as in claim 1 or different. Appropriate correction required. Because of indefiniteness brought by claim 8-11, 13-14, 16-17, 19-21 , these claims have not been searched for the prior art and is not examined. However, should an amended version of the claims be presented for the next action on the merits, the action may be made final. Claim Rejections - 35 USC § 112 The following is a quotation of 35 U.S.C. 112(d): (d) REFERENCE IN DEPENDENT FORMS.— Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers. The following is a quotation of 35 U.S.C. 112 (pre-AIA), fourth paragraph: Subject to the [fifth paragraph of 35 U.S.C. 112 (pre-AIA)], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers. Claim s 3-6 and 8-11, 13-14, 16-17, 19-21 are rejected under 35 U.S.C. 112(d), as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim s 3-6 and 8-11, 13-14, 16-17, 19-21 are in an impr oper dependent form because: Claim s 3-6 dependent on claim 2 recites solvent outside the scope of claim 2 , which makes claim s improper and broader than claim 2 . For instance, solvents cyclohexanone, isopropene acetate, heptane, hexane, toluene. 8-11, 13-14, 16-17, 19-21 are in an improper dependent form , because these claim s recite individual method of making oxybate salts using process steps different from the instant claim 1 and temperature outside the scope of claim 1. Thus, br oader in scope. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements. 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 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. (a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention. Claims 1- 5, 7 and 22-23 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Allphin (US 9555017 B2 ). Allphin disclose s a process of making mixed oxybate salts, such as comprising salts of Na 5% to about 10% or 8% (8%) , K about 25% to about 30% (26%), Mg about 20% (19%) and Ca about 45-50%w/w (50%) (the term about means 50%, 20%---5%, 4%, 3%, 2%, 1%, 0.5% 0r 0.05% of a given value or range) (reads on limitation when all salts are present and their % of 8%, 26%, 19% and 50% of Na, K, Mg and Ca respectively) or salts of Na, K, and Ca or salts of K, Mg, Ca; pharmaceutical composition with pharmaceutically acceptable excipient and liquid dosage formulation (entire patent, especially abstract, col 2 -4 , 7-16 , 20 and 24 ) . The cited prior art discloses that either gamma-butyrolactone (GBL) is treated with one or more bases selected from the group consisting of NaOH, KOH, Mg( OH)2 and Ca(OH)2 in a single vessel to make mixture of salts or the reaction is carried out in multiple vessels and product is subsequently combined entire patent, especially abstract, col 2-4, 7-16, 20 and 24) . The cited prior art discloses that the final mixture or one salt containing composition may be prepared by dissolving salt or mixture (active agent) in a solvent, such as purified water, ethanol at room temperature followed by filtration and sterilization entire patent, especially abstract, col 2-4, 7-16, 20 and 24) . The cited prior art discloses specific method of making and also provides that literature methods described US Pat no. 4393236; may also be incorporated in the m e thod of making ( see col 24). The cited prior art discloses that mixture of GHB may be made by direct reaction of GBL with an aqueous mixture of one or more bases: NaOH, KOH, Mg( OH)2 and Ca(OH)2 , after reaction, the mixture may be filtered under vacuum, a solvent, such as water is used to dissolve GHB mixture to a desired concentration ( see col 24). Klosa ( US Pat no. 4393236 ) method may be incorporated in the synthesis. Klosa discloses crystallization steps of the salt , which are incorporated in the Allphine patent . Specifically, Klosa disclose s a process of making oxybate salts or mixed salt, such as comprising salts of Mg and/or Ca, with example: Ca(OH)2 is treated with gamma-butyrolactone (GBL) in water and after preparation of oxybate salt of calcium, the salt is mixed with stirring in a solvent, methanol, acetone for crystallization without heating or changing temperature (i.e. temperature is room temperature), followed by filtration and washing with the solvent methanol and acetone (see col 5, example 2) (entire patent, especially col 4-10, examples, and claims) (reads on the instant claims 1-5 and 7). Another example in Col 5, example 3 discloses another example wherein salt is dissolved in solvent water and methanol followed by acetone without heating or changing temperature (i.e. temperature is room temperature), the crystalized salt is filtered and washed with methanol and acetone (entire patent, especially col 4-10, examples, and claims). The example also discloses that ethanol or isopropyl alcohol may also be used instead of methanol for crystallization. Examples 4 and 5 discloses preparation of Mg oxybate salt (entire patent, especially col 4-10, examples, and claims). The cited prior art further discloses (see col 4) making pharmaceutical composition comprising the salt and/or salts comprising pharmaceutical excipient and liquid dosage form formulation (entire patent, especially col 4-10, examples, and claims) (reads on the instant claims 22 and 23) . Although the instant claim s 22-23 are product-by-process claim, the case law has established that “Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe , 777 F.2d 695, 698, 227 USPQ 964, 966 ( Fed. Cir. 1985). Furthermore, “ because validity is determined based on the requirements of patentability, a patent is invalid if a product made by the process recited in a product-by-process claim is anticipated by or obvious from prior art products, even if those prior art products a re made by different processes.” Amgen Inc. v. F. Hoffman-La Roche Ltd. , 580 F.3d 1340, 1370 n 14, 92 USPQ2d 1289, 1312, n 14 (Fed. Cir. 2009). Since the cited prior art reads on all the limitations of the instant claims 1- 5, 7 and 22-23 , these claims are anticipated. Claims 1- 5, 7 and 22-23 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Klosa (US 4393236 B2 ). Klosa disclose s a process of making oxybate salts or mixed salt , such as comprising salts of Mg and /or Ca , with example: Ca(OH)2 is treated with gamma-butyrolactone (GBL) in water and after preparation of oxybate salt of calcium, the salt is mixed with stirring in a solvent, methanol, acetone for crystallization without heating or changing temperature (i.e. temperature is room temperature ) , followed by filtration and washing with the solvent methanol and acetone (see col 5, example 2) ( entire patent, especially col 4-10 , examples , and claims ) (reads on the instant claims 1-5 and 7) . Another example in Col 5, example 3 discloses another example wherein salt is dissolved in solvent water and methanol followed by acetone without heating or changing temperature (i.e. temperature is room temperature) , the crystalized salt is filtered and washed with methanol and acetone (entire patent, especially col 4-10, examples, and claims) . The example also discloses that ethanol or isopropyl alcohol may also be used instead of methanol for crystallization. Examples 4 and 5 discloses preparation of Mg oxybate salt (entire patent, especially col 4-10, examples, and claims) . The cited prior art further discloses (see col 4) making pharmaceutical composition comprising the salt and/or salts comprising pharmaceutical excipient and liquid dosage form formulation ( entire patent, especially col 4-10, examples, and claims) . Although the instant claim s 22-23 are product-by-process claim, the case law has established that “Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe , 777 F.2d 695, 698, 227 USPQ 964, 966 ( Fed. Cir. 1985). Furthermore, “ because validity is determined based on the requirements of patentability, a patent is invalid if a product made by the process recited in a product-by-process claim is anticipated by or obvious from prior art products, even if those prior art products a re made by different processes.” Amgen Inc. v. F. Hoffman-La Roche Ltd. , 580 F.3d 1340, 1370 n 14, 92 USPQ2d 1289, 1312, n 14 (Fed. Cir. 2009). Since the cited prior art reads on all the limitations of the instant claims 1- 5, 7 and 22-23 , these claims are anticipated. 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 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 of this title, 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. The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action. The factual inquiries set forth in Graham v. John Deere Co. , 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows: 1. Determining the scope and contents of the prior art. 2. Ascertaining the differences between the prior art and the claims at issue. 3. Resolving the level of ordinary skill in the pertinent art. 4. Considering objective evidence present in the application indicating obviousness or nonobviousness . This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention. Claims 1- 5, 7 and 22-23 are rejected under 35 U.S.C. 103 as being unpatentable over Allphin (US 9555017 B2 ) and Klosa (US 4393236) in combination. Determining the scope and contents of the prior art Allphin disclose s a process of making mixed oxybate salts, such as comprising salts of Na 5% to about 10% or 8% (8%), K about 25% to about 30% (26%), Mg about 20% (19%) and Ca about 45-50%w/w (50%) (the term about means 50%, 20%---5%, 4%, 3%, 2%, 1%, 0.5% 0r 0.05% of a given value or range) (reads on limitation when all salts are present and their % of 8%, 26%, 19% and 50% of Na, K, Mg and Ca respectively) or salts of Na, K, and Ca or salts of K, Mg, Ca; pharmaceutical composition with pharmaceutically acceptable excipient and liquid dosage formulation (entire patent, especially abstract, col 2-4, 7-16, 20 and 24). The cited prior art discloses that either gamma-butyrolactone (GBL) is treated with one or more bases selected from the group consisting of NaOH, KOH, Mg( OH)2 and Ca(OH)2 in a single vessel to make mixture of salts or the reaction is carried out in multiple vessels and product is subsequently combined entire patent, especially abstract, col 2-4, 7-16, 20 and 24). The cited prior art discloses that the final mixture or one salt containing composition may be prepared by dissolving salt or mixture (active agent) in a solvent, such as purified water, ethanol at room temperature followed by filtration and sterilization entire patent, especially abstract, col 2-4, 7-16, 20 and 24). The cited prior art discloses specific method of making and also provides that literature methods described Klosa ( US Pat no. 4393236 ) may also be incorporated in the method of making (see col 24). The cited prior art discloses that mixture of GHB may be made by direct reaction of GBL with an aqueous mixture of one or more bases: NaOH, KOH, Mg( OH)2 and Ca(OH)2 , after reaction, the mixture may be filtered under vacuum, a solvent, such as water is used to dissolve GHB mixture to a desired concentration (see col 24). Klosa (US Pat no. 4393236) method may be incorporated in the synthesis of Allphin . Although the instant claim s 22-23 are product-by-process claim, the case law has established that “Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe , 777 F.2d 695, 698, 227 USPQ 964, 966 ( Fed. Cir. 1985). Furthermore, “ because validity is determined based on the requirements of patentability, a patent is invalid if a product made by the process recited in a product-by-process claim is anticipated by or obvious from prior art products, even if those prior art products a re made by different processes.” Amgen Inc. v. F. Hoffman-La Roche Ltd. , 580 F.3d 1340, 1370 n 14, 92 USPQ2d 1289, 1312, n 14 (Fed. Cir. 2009). Ascertaining the differences between the prior art and the claims at issue Allphin disclose s a process of making mixed oxybate salts, such as comprising salts of Na 5% to about 10% or 8% (8%), K about 25% to about 30% (26%), Mg about 20% (19%) and Ca about 45-50%w/w (50%) (the term about means 50%, 20%---5%, 4%, 3%, 2%, 1%, 0.5% 0r 0.05% of a given value or range) (reads on limitation when all salts are present and their % of 8%, 26%, 19% and 50% of Na, K, Mg and Ca respectively) or salts of Na, K, and Ca or salts of K, Mg, Ca; pharmaceutical composition with pharmaceutically acceptable excipient and liquid dosage formulation . Allphine further teaches general method of synthesis of making single salt or mixture of salts and incorporates reference Klosa (US Pat no. 4393236) for modification in synthesis, further steps for making such composition and formulation. The cited prior art is silent about steps such as crystallization etc., which are elaborated by Klosa and incorporated in Allphin reference. Resolving the level of ordinary skill in the pertinent art With regards to the above difference- Klosa discloses crystallization steps of the salt , which are incorporated in the Allphine patent . Specifically, Klosa disclose s a process of making oxybate salts or mixed salt, such as comprising salts of Mg and/or Ca, with example: Ca(OH)2 is treated with gamma-butyrolactone (GBL) in water and after preparation of oxybate salt of calcium, the salt is mixed with stirring in a solvent, methanol, acetone for crystallization without heating or changing temperature (i.e. temperature is room temperature), followed by filtration and washing with the solvent methanol and acetone (see col 5, example 2) (entire patent, especially col 4-10, examples, and claims) (reads on the instant claims 1-5 and 7). Another example in Col 5, example 3 discloses another example wherein salt is dissolved in solvent water and methanol followed by acetone without heating or changing temperature (i.e. temperature is room temperature), the crystalized salt is filtered and washed with methanol and acetone (entire patent, especially col 4-10, examples, and claims). The example also discloses that ethanol or isopropyl alcohol may also be used instead of methanol for crystallization. Examples 4 and 5 discloses preparation of Mg oxybate salt (entire patent, especially col 4-10, examples, and claims). The cited prior art further discloses (see col 4) making pharmaceutical composition comprising the salt and/or salts comprising pharmaceutical excipient and liquid dosage form formulation (entire patent, especially col 4-10, examples, and claims) (reads on the instant claims 22 and 23). Thus, based on the guidance provide by the cited prior art, it would have been prima facie obvious to a person of ordinary skill in the art that Klosa’s steps of crystallization may be incorporated in the process of Allphin , as taught by Allphin . Further, a person of ordinary skill in the art would have been motivated to incorporate steps of crystallization to ensure purity of product and especially for a pharmaceutical composition for human use. Based on the above established facts, it appears that the combination of teachings of above cited prior art read applicants’ process. Therefore, all the claimed elements were known in the prior art and one skilled person in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination would have yielded predictable results to one of ordinary skill in the art at the time of the invention. Considering objective evidence present in the application indicating obviousness or nonobviousness To establish a prima facie case of obviousness, three basic criteria must be met: (1) the prior art reference must teach or suggest all the claim limitations; (2) there must be some suggestion or motivation, either in the references themselves or in the knowledge generally available to one of ordinary skill in the art, to modify the reference or to combine reference teachings; and (3) there must be a reasonable expectation of success; and (MPEP § 2143). In this case, Allphin disclose s a process of making mixed oxybate salts, such as comprising salts of Na, K, Mg and Ca or salts of Na, K, and Ca or salts of K, Mg, Ca; pharmaceutical composition with pharmaceutically acceptable excipient and liquid dosage formulation. Allphine further teaches general method of synthesis of making single salt or mixture of salts and incorporates reference Klosa (US Pat no. 4393236) for modification in synthesis, further steps for making such composition and formulation. Klosa discloses crystallization steps of the salt , which are incorporated in the Allphine patent . So, the combination of prior art read applicants claims. In KSR International Vo. V. Teleflex Inc., 82 USPQ2d (U.S. 2007), the Supreme Court particularly emphasized “the need for caution in granting a patent based on a combination of elements found in the prior art,” (Id. At 1395) and discussed circumstances in which a patent might be determined to be obvious. Importantly, the Supreme Court reaffirmed principles based on its precedent that “[t]he combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results.” (Id. At 1395). See MPEP 2143 - Examples of Basic Requirements of a Prima Facie Case of Obviousness [R-9] . In th is case at least prong ( E) “Obvious to try ” – choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success would apply. The rationale to support a conclusion that the claim would have been obvious is that “a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely that product [was] not of innovation but of ordinary skill and common sense. In that instance the fact that a combination was obvious to try might show that it was obvious under § 103 .”KSR , 550 U.S. at ___, 82 USPQ2d at 1397. If any of these findings cannot be made, then this rationale cannot be used to support a conclusion that the claim would have been obvious to one of ordinary skill in the art. It is well within the skill of the organic chemist to recognize the fact that applicants claimed process is nothing but the combination of known individual chemical processes. Further, there is a reasonable expectation of success that the crystallization steps may be combined with making oxybate salts and can be made by combination of the above cited prior art . Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention by taking the advantage of the teaching of the above cited references and to make the instantly claimed process with a reasonable expectation of success. Modifying such parameters is prima facie obvious because an ordinary artisan would be motivated to develop an alternative process for economic reasons or convenient purposes from a known individual reaction steps, and to arrive applicants process with a reasonable expectation of success, since it is within the scope to modify the process through a routine experimentation. Conclusion No claim is allowed. Any inquiry concerning this communication or earlier communications from the examiner should be directed to FILLIN "Examiner name" \* MERGEFORMAT PANCHAM BAKSHI whose telephone number is FILLIN "Phone number" \* MERGEFORMAT (571)270-3463 . The examiner can normally be reached FILLIN "Work Schedule?" \* MERGEFORMAT M-Thu 7-4.30 EST . 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. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, FILLIN "SPE Name?" \* MERGEFORMAT Milligan Adam can be reached at FILLIN "SPE Phone?" \* MERGEFORMAT 571-2707674 . The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /PANCHAM BAKSHI/ Primary Examiner, Art Unit 1623