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 § 102
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.
Claims 16-30 and 32 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hirose et al. EP 2,694,043 B1.
Hirose teaches an oral solid composition comprising 7-[4-(4- benzo[b]thiophen-4-yl-piperazin-1-yl)butoxy]-1 H-quinolin-2-one and a salt thereof such as fumaric acid. See paragraphs 0010-0011, 0024-0026 and 0084. The composition is for the treatment of CNS disease is found in page 3, items 7-9. 7-[4-(4- benzo[b]thiophen-4-yl-piperazin-1-yl)butoxy]-1 H-quinolin-2-one dosing at 5-60 mg is found in paragraph 0041. Osmotic pump dosage form comprising 7-[4-(4- benzo[b]thiophen-4-yl-piperazin-1-yl)butoxy]-1 H-quinolin-2-one and one or more cellulosic polymer is found in paragraphs 0206-0209. Enteric coating hydrogel dosage form is found in paragraphs 0118-0123. Once weekly administration is found in paragraph 0087. Hirose further teaches the medicaments of the present invention comprising Compound (I) or a salt thereof, drug (II) and/or Compound (I) or a salt thereof and drug (II) in combination, which are constituent components of the present invention, show low toxicity and, for example, Compound (I) or a salt thereof and/or drug (II) can be mixed with a pharmacologically acceptable carrier according to a known method to give a pharmaceutical composition, such as tablets (including sugar-coated tablet, film-coated tablet), powders, granules, capsules (including soft capsule), liquids, injections, suppositories, sustained-release preparations and the like, which can be safely administered orally or parenterally (e.g., local, rectum, vein, and the like). An injection can be administered by intravenous, intramuscular, subcutaneous or intraorgan administration or directly to the lesion. As a pharmacologically acceptable carrier which may be used for producing the pharmaceutical composition of the present invention, excipient, disintegrant, binder, fluidizer, lubricant, coating agent, colorant, suspending agent, sweetening agent or surfactant is appropriately used, and a general pharmaceutical preparation is formed according to a known method. Examples of the form of the pharmaceutical preparation include powder, tablet, pill, capsule and the like. See paragraph 0026. Method for the treatment of various central nervous system disorders is found in paragraphs 0054-0055. Compositions comprising the claimed excipients including hydroxypropyl methyl cellulose is found in paragraphs 0026-0032. Osmotic pump is found in paragraph 0087.
It is noted that Hirose does not expressly teach the claimed property such as the blood concentration in a steady state recited in claim 28. However, because Hirose teaches the same controlled release oral dosage form comprising the claimed compound useful for the same treatment, the property of the dosage form is expected to be similar. Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed product. In re Best, 562 F.2d at 1255, 195 USPQ at 433. See also Titanium Metals Corp. v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985) (Claims were directed to a titanium alloy containing 0.2-0.4% Mo and 0.6-0.9% Ni having corrosion resistance. A Russian article disclosed a titanium alloy containing 0.25% Mo and 0.75% Ni but was silent as to corrosion resistance. The Federal Circuit held that the claim was anticipated because the percentages of Mo and Ni were squarely within the claimed ranges. The court went on to say that it was immaterial what properties the alloys had or who discovered the properties because the composition is the same and thus must necessarily exhibit the properties.
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.
Claim 31 is rejected under 35 U.S.C. 103 as being unpatentable over Hirose et al. EP 2,694,043 B1, in view of Sato et al. US 2015/0272946 A1.
Hirose is relied upon for the reason stated above. Hirose does not teach the hydrate form of the claimed compound.
Sato teaches brexpiprazole in hydrate form in an oral dosage form is useful in pharmaceutical art. See paragraph 0098.
Thus, it would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to select hydrate form of brexpiprazole in view of the teaching of Sato with the expectation of at least similar result. This is because Sato teaches the use of hydrate form of brexpiprazole in an oral dosage form is known and useful in pharmaceutical art.
Correspondence
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/SUSAN T TRAN/Primary Examiner, Art Unit 1615
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