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 Objections Claim s 1-2 5 are objected to because of the following informalities: the claims read upon text having a different color/shading such as the text “A medium” in claim 1 rendering the text illegible . Appropriate correction is required. 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 (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 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. Claim(s) 1-5, 7-21, 25, and 27-32 is/are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Alban, Susanne, Dieter Welzel , and H. Coenraad Hemker . "Pharmacokinetic and pharmacodynamic characterization of a medium-molecular-weight heparin in comparison with UFH and LMWH." Seminars in thrombosis and hemostasis . Vol. 28. No. 04. Copyright© 2002 by Thieme Medical Publishers, Inc., 333 Seventh Avenue, New York, NY 10001, USA. Tel.:+ 1 (212) 584-4662, 2002 (Alban) . Alban teaches a medium-molecular-weight heparin (MMWH) , a new heparin with an average molecular weight of 10.5 kDa and a narrow molecular weight range (9.5 to 11.5 kDa ) (Abstract). Its in vitro activities amount to 174.9 anti-factor Xa ( aXa ) U/mg and 170.0 antithrombin ( aIIa ) U/mg. In the presented randomized, double-blind, cross-over study in healthy volunteers, the pharmacokinetics and pharmacodynamics of MMWH are compared with those of an unfractionated heparin (UFH) and a low-molecular-weight heparin (LWMH; enoxaparin). After subcutaneous administration of 9000 aXa -U of either heparin in 16 volunteers, the prolongation of the activated partial thromboplastin time ( aPTT ), the aXa activity, and the aIIa activities were determined at 11 time points spread over 24 hours after injection . The ex vivo analysis revealed striking pharmacodynamic and pharmacokinetic differences between the three heparins. UFH had the lowest bioavailability regarding the aPTT , aXa , and aIIa activities. Enoxaparin exhibited only low aIIa activity but the highest aXa activity. Unlike UFH and enoxaparin, MMWH showed a high recovery of aIIa activity, which suggests that it combines the high potency to inhibit thrombin that characterizes UFH with the high bioavailability of the LMWHs. Consequently, substantially lower doses are needed to bring about effects comparable to those of UFH and LMWH . Thus, Alban teaches a pharmaceutical formulation suitable for subcutaneous administration (e.g., injection) comprising MMWH with an average molecular weight of 10.5 kDa . The pharmaceutical formulation comprising the MMWH of Alban is capable of performing the claimed intended use. Alban teaches all of the instantly claimed elements. Thus, claims 1-5, 7-21, 25, and 27-32 are anticipated. Claim(s) 1-5, 7-21, 25, and 27-32 is/are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Welzel EP 3348270 A1 ( Welzel ). Welzel is drawn to medium molecular weight heparin (MMWH 10. 5 kD ) for prevention and treatment of venous thromboembolism in malignant disease (Abstract) . Welzel teaches that MMWH for use in treatment of venous thromboembolism in malignant disease was compared to two LMWHs, namely enoxaparin and certoparin [0056] . The detailed findings laid down in Figures 6, 7 and 8 and Tables 2, 3, 4, 5 and 6 furnish consistent evidence of MMWH’s surprising superiority over both LMWHs with respect to both antithrombotic efficacy and tolerance. Table 4 is drawn to a ntithrombotic actions of the subcutaneous administration of MMWH and enoxaparin in a rabbit statis thrombosis model. Thus, Wenzel teaches a pharmaceutical formulation suitable for subcutaneous administration (e.g., injection) comprising MMWH with an average molecular weight of 10.5 kDa . The pharmaceutical formulation comprising the MMWH of Wenzel is capable of performing the claimed intended use. Wenzel teaches all of the instantly claimed elements. Thus, claims 1-5, 7-21, 25, and 27-32 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 (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. The factual inquiries 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 . Claim(s) 22 and 33 is/are rejected under 35 U.S.C. 103 as being unpatentable over Alban, Susanne, Dieter Welzel , and H. Coenraad Hemker . "Pharmacokinetic and pharmacodynamic characterization of a medium-molecular-weight heparin in comparison with UFH and LMWH." Seminars in thrombosis and hemostasis . Vol. 28. No. 04. Copyright© 2002 by Thieme Medical Publishers, Inc., 333 Seventh Avenue, New York, NY 10001, USA. Tel.:+ 1 (212) 584-4662, 2002 (Alban) as applied to claim s 1-5, 7-21, 25, and 27-32 above . Alban differs from the instantly claimed invention in that Alban does not explicitly teach a composition comprising MMWH and an additional active agent; however, this deficiency would have been obvious. In determining the differences between the prior art and the claims, the question under 35 U.S.C. 103 is not whether the differences themselves would have been obvious, but whether the claimed invention as a whole would have been obvious. Stratoflex , Inc. v. Aeroquip Corp., 713 F.2d 1530, 218 USPQ 871 (Fed. Cir. 1983); Schenck v. Nortron Corp., 713 F.2d 782, 218 USPQ 698 (Fed. Cir. 1983). It would have been obvious to combine the MMWH formulation of Alban with LMWH in order reduce the amount of LMWH employed . One would have been motivated with a reasonable expectation of success as Alban teaches that substantially lower doses of MMWH are needed to bring about effects comparable to those of LMWH. Thus, claims 22 and 33 would have been obvious based upon the preponderance of evidence. Conclusion Claims 1-33 are pending. Claims 1-5, 7-22, 25, and 27-33 are rejected. Claims 6 and 23-24 are objected to. Claim 26 is allowed. The following is a statement of reasons for the indication of allowable subject matter: Welzel EP 3348270 A1 ( Welzel ) is representative of prior art . Welzel does not teach or suggest a method wherein the patient has a plasma von Willebrand factor antigen to ADAMTS13 ratio of at least about 2. Contacts Any inquiry concerning this communication or earlier communications from the examiner should be directed to FILLIN "Examiner name" \* MERGEFORMAT PATRICK T LEWIS whose telephone number is FILLIN "Phone number" \* MERGEFORMAT (571)272-0655 . The examiner can normally be reached FILLIN "Work Schedule?" \* MERGEFORMAT Monday to Friday, 10 AM to 4 PM EST (Maxi Flex) . 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 Renee Claytor can be reached at FILLIN "SPE Phone?" \* MERGEFORMAT (571) 272-8394 . 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. /PATRICK T LEWIS/ Primary Examiner, Art Unit 1691 /PL/