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 § 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.
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) 95 is/are rejected under 35 U.S.C. 103 as being unpatentable over Becker et al (US 2007/0036857 hereafter Becker) in view of Jain (US 9,642,808 hereafter Jain).
Becker discloses a pharmaceutical formulation comprising a plurality of particulate subunits comprising a core having a diameter less than 3 mm, 0.2 to 2 mm [0017, 0018]. The active layer is disposed over a portion of the core and comprises mycophenolic acid, such as sodium mycophenolate [0051], a controlled-release layer disposed over the core and an protective enteric layer disposed over the controlled release layer [0045, 0054, Example]. These disclosures meet the limitation of claim 95, i-iv.
The reference, while disclosing a pharmaceutical formulation comprising a plurality of particulate subunits comprising core having less than 3 mm, an active layer disposed on the core, a controlled-release layer and a protective layer comprising methacrylate disposed over the protective layer. The reference does not however disclose the plasma concentration of the dosage form. These release kinetics are known in the art as seen in the Jain patent.
Jain disclose an extended release formulation for mycophenolate sodium (abstract). Jain discloses a formulation comprising a plurality of subunit particles that measure about 390 microns, which is less than 3 mm (col. 16, lin. 42-53). The particles are coated with a drug layer, followed by a protective layer and a methacrylate layer (col. 20, lin. 15-20; col. 20, lin. 25-30, Example 19). These dosage forms are administered orally and over an 8 hour period, achieves an average plasma of about 1600 ng/ml (col. 22, lin. 45-col. 23, lin. 45). The formulation is useful in reducing gastrointestinal events including diarrhea, and emesis in patients upon administration that are normally associated with mycophenolate sodium (Table 1). It would have been obvious apply the formulations into an extended release formulations as they solve the same problem as Becker.
Regarding the reduction of lymphocyte proliferation in blood samples, and gastrointestinal effects, it is the position of the Examiner that the combination of the prior art would meet these limitations as well. The claims are drawn to a pharmaceutical formulation comprising a plurality of cores, drug layers, a controlled release layer and a protective methacrylate layer, where the formulation achieves an average plasma of 1600, between the 250-3000 ng/ml over the same period of time. The remaining features would naturally fall from the administration of the formulations as they fall from the compositional features of the formulation. These reductions in lymphocytes in whole blood as measured by a monoclonal antibody Ki-67, and reduction in GI events are properties that result from the combination of compositional components that form the product. They are the properties of the pharmaceutical product and as such cannot be separated from the product. Products of identical chemical composition cannot have mutually exclusive properties.” A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990).
For these reasons, it would have been obvious to combine the prior part with an expected result of an oral formulation useful in treating immunosuppressant indicated diseases. It would have been obvious that the formulation of Becker would have a plasma concentration as seen in Jain as they have similar structure and function. Jain establishes the level of skill in the art regarding the kinetics of these formulation and one of ordinary skill in the art would have been motivated to follow these teachings and apply them to the formulation Becker as they solve a similar problem. One of ordinary skill in the art would have been motivated to combine the prior art with an expected result of a stable pharmaceutical formulation useful in treating immunosuppressant conditions.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICAH PAUL YOUNG whose telephone number is (571)272-0608. The examiner can normally be reached Monday through Friday, 9:00 am to 5:30 pm.
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/MICAH PAUL YOUNG/Primary Examiner, Art Unit 1618