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 1-15 are pending and examined. Claim Rejections - 35 USC § 112 Claim 4 is 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. The phrase “essentially” non-aqueous is not clear. The Specification defines “essentially non-aqueous” to be understood to mean is “substantially free of water.” The examiner notes that substantially is also indefinite. It is not clear what the metes and bounds of essentially and substantially are. Claims 14 and 15 are rejected, pursuant to M.P.E.P. § 2173.05(q), which explains: “ Attempts to claim a process without setting forth any steps involved in the process generally raises an issue of indefiniteness under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.” Moreover, “Although a claim should be interpreted in light of the specification disclosure, it is generally considered improper to read limitations contained in the specification into the claims. See In re Prater, 415 F.2d 1393, 162 USPQ 541 (CCPA 1969) and In re Winkhaus, 527 F.2d 637, 188 USPQ 129 (CCPA 1975), which discuss the premise that one cannot rely on the specification to impart limitations to the claim that are not recited in the claim.” Here, claims 14 and 15 are indefinite for reciting a “use” without reciting an actual step of administering a composition to a subject. The language “for oral delivery of apixaban is administered” is not a step for administering the claimed agent to a subject. NOTE : Each reference cited below is assigned to the same assignee. Claim Rejections - 35 USC § 103 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- 4 and 7- 15 are rejected under 35 U.S.C. 103 as being unpatentable over Badawy et al. , (WO2014/052678) (cited in ISR) , in view of Badawy et al. , (U.S. Pat. No. 10,016,362) (“Badawy2”). Badawy teaches apixaban liquid formulations intended for oral use with 0.4 mg/ml apixaban, e.g. Apixaban can be soluble to at least 0.5 mg/ml. See par. 7. The solubility in a vehicle can be about 0.6 mg/ml. See par. 21. Table 1 provides concentrations of solubilizers in vehicle. The propylene glycol and glycerin are up to 20% and 30%. Thus, co-solvents and solvents are 50%. Sodium lauryl sulfate is contemplated in an amount of 0.5% and fructose at about 20%. See par. 37. A flavoring agent and sweetener can be used. See par. 38. It can be used to treat a thromboembolic disorder in a patient in need thereof. See par. 42. Examples includes many set forth in par. 49. Administration can be through a dosing syringe, nasogastric tube, and/or gastronomy tube for oral delivery. See par. 9. The examiner considers a syringe to include plastic syringes or glass syringes, and the limited options in the art would have a POSA immediately envisage plastic syringes. Polyhydric alcohols that can be used include glycerin, propylene glycol, sorbitol, and mannitol. See par. 30. It can be in the form of a solution. See par. 68 and 69, e.g. Non-ionic and ionic surfactants can be used as well. See par. 9. Badawy teaches preservatives to be includes such as parabens. See par. 38. Badawy2 teaches liquid Apixaban formulations. See Abstract. Polyhydric alcohols can be glycerin, propylene glycol, sorbitol, and mannitol. Prior art claim 8 provides for a formulation that includes apixaban, glycerin, propylene glycol, SLS, sucrose, and other components wherein the composition does not include n or require water . See independent prior art claim 8. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); Similarly, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985); and Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here 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, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). The solvents and co-solvents described by the prior art can combine to form a percentage that is sufficient and predictable to solubilize the amount of apixaban necessary for administration. Further, stirring and the use of heat are well-known to aid in dissolution of an API in a known solvent. Stirring with heat until dissolution is the only step required in claim 10. It would have been prima facie obvious to a person of ordinary skill in the art prior to the filing the instant application to arrive at the claimed products in view of the cited prior art. Each cited reference is assigned to the same assignee. Apixaban is known to not be water soluble. The claimed API at a claimed dosage is taught for a claimed use. Further, the solvents and co-solvents and other components are each taught for use with apixaban. There is a motivation with a reasonable and predictable expectation of success in arriving at the claimed combination of agents in view of the cited prior art. The result-effective variables can be optimized and the concentrations of solvents and co-solvents when combined appears to overlap the claimed concentrations. Each agent claimed is motivated and used in an embodiment with the claimed API by the cited prior art and water is not required in view of the Badawy2, e.g. Each of the cited references are assigned by the same assignee. As such, no claim is allowed. Claims 1-15 are rejected under 35 U.S.C. 103 as being unpatentable over Badawy et al. , (WO2014/052678) (cited in ISR) , in view of Badawy et al. , (U.S. Pat. No. 10,016,362) (“Badawy2”) , and in view of Nause , (US2012/0087978). Badawy teaches apixaban liquid formulations intended for oral use with 0.4 mg/ml apixaban, e.g. Apixaban can be soluble to at least 0.5 mg/ml. See par. 7. The solubility in a vehicle can be about 0.6 mg/ml. See par. 21. Table 1 provides concentrations of solubilizers in vehicle. The propylene glycol and glycerin are up to 20% and 30%. Thus, co-solvents and solvents are 50%. Sodium lauryl sulfate is contemplated in an amount of 0.5% and fructose at about 20%. See par. 37. A flavoring agent and sweetener can be used. See par. 38. It can be used to treat a thromboembolic disorder in a patient in need thereof. See par. 42. Examples includes many set forth in par. 49. Administration can be through a dosing syringe, nasogastric tube, and/or gastronomy tube for oral delivery. See par. 9. The examiner considers a syringe to include plastic syringes or glass syringes, and the limited options in the art would have a POSA immediately envisage plastic syringes. Polyhydric alcohols that can be used include glycerin, propylene glycol, sorbitol, and mannitol. See par. 30. It can be in the form of a solution. See par. 68 and 69, e.g. Non-ionic and ionic surfactants can be used as well. See par. 9. Badawy teaches preservatives to be includes such as parabens. See par. 38. Badawy2 teaches liquid Apixaban formulations. See Abstract. Polyhydric alcohols can be glycerin, propylene glycol, sorbitol, and mannitol. Prior art claim 8 provides for a formulation that includes apixaban, glycerin, propylene glycol, SLS, sucrose, and other components wherein the composition does not include n or require water. See independent prior art claim 8. Badawy and Badawy2 do not teach the claimed antioxidants. Nause teaches dosage forms of apixaban that can take oral form of solutions, e.g. See par. 3 and 10, e.g. Nause teaches the use of liquid ingredients, including those such as antioxidants, such as BHA, BHT, propyl gallate , etc.) and other preservatives such as parabens. See par. 226. Surfactants and co-solvents are also contemplated. See par. 228-233. One embodiment comprises apixaban dissolved in a liquid. See par. 10. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); Similarly, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985); and Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here 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, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). The solvents and co-solvents described by the prior art can combine to form a percentage that is sufficient and predictable to solubilize the amount of apixaban necessary for administration. Further, stirring and the use of heat are well-known to aid in dissolution of an API in a known solvent. Stirring with heat until dissolution is the only step required in claim 10. It would have been prima facie obvious to a person of ordinary skill in the art prior to the filing the instant application to arrive at the claimed products in view of the cited prior art. Each cited reference is assigned to the same assignee. Apixaban is known to not be water soluble. The claimed API at a claimed dosage is taught for a claimed use. Further, the solvents and co-solvents and other components are each taught for use with apixaban. Antioxidants are taught for use with apixaban in additional to parabens, which are known preservatives. There is a motivation with a reasonable and predictable expectation of success in arriving at the claimed combination of agents in view of the cited prior art. The result-effective variables can be optimized and the concentrations of solvents and co-solvents when combined appears to overlap the claimed concentrations. Each agent claimed is motivated and used in an embodiment with the claimed API by the cited prior art and water is not required in view of the Badawy2, e.g. As such, no claim is allowed. Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to JARED D. BARSKY whose telephone number is FILLIN "Phone number" \* MERGEFORMAT (571)272-2795 . The examiner can normally be reached on FILLIN "Work schedule?" \* MERGEFORMAT 9-5 M-F . If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amy L. Clark can be reached on 571-272-1310. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /JARED BARSKY/ Primary Examiner, Art Unit 1628