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`IN RE APPLICATION OF:
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`YOSHIHIRO FUJIKAWA ET AL
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`:
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`:
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`GROUP ART UNIT:
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`DIVISIONAL APPLICATION DIVIDED FROM
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`EXAMINER:
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`: :
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`SERIAL NO.:
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`07/631,092
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`FOR:
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`QUINOLINE TYPE MEVALONOLACTONES
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`:
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`DECLARATION UNDER 37 CFR 1.132
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`HONORABLE COMMISSIONER OF PATENTS & TRADEMARKS
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`WASHINGTON, D.C.
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`20231
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`SIR:
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`I, Masaki Kitahara, do hereby declare and state
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`that:
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`l. I am a named co-inventor in the above-captioned
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`patent application, an employee of Nissan Chemical
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`Industries, Limited, and a citizen and resident of Japan.
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`2.
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`I am familiar with the above-captioned patent
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`application, and Claims presented by Divisional
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`Application.
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`3. To demonstrate the unobvious superiority of the
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`subject matter claimed therein, comparative tests were
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`conducted, demonstrating the importance and unobvious
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`superiority conferred on these compounds by the selection
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`gwr.“
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`Mylan Exhibit 1032, Page 1
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`Mylan Exhibit 1032, Page 1
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`-of the oyclopropyl
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`(c—Pr) substituent. These are
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`described as follows:
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`Data was obtained with regard to the following
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`compound having the formula:
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`OH
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`0}-{C00 - 1/2Ca F
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`@ I
`@ ON
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`R‘
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`Comgound
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`gfi
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`Evaluation
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`Evaluation
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`TEST METHOD
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`Test A
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`Test B
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`Compound
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`of this
`Invention
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`cyclopropyl
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`4.4 x 10*9
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`35.0 x 10—9
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`(c—Pr)
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`Reference
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`isopropyl
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`23.0 x 10-9
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`105 x 10-9
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`Compound
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`(i-Pr)
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`Test A:
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`Inhibition of cholesterol
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`biosynthesis from acetate in vitro
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`This test was carried out as described on pages
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`28-29 of the specification.
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`The above numerical values
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`indicate IC5o (molar concentration).
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`Mylan Exhibit 1032, Page 2
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`Mylan Exhibit 1032, Page 2
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`O
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`O
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`Test B:
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`inhibition of cholesterol
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`bios nthesis in culture cells
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`This test was carried out as described on pages 29
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`to 30 of the specification.
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`The above numerical values
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`indicate IC5o (molar concentration).
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`4. Based on the data reported above, it can be
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`determined that the compound of this invention exhibits
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`unobvious superiority, and in particular, sharply enhanced
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`inhibition of cholesterol biosynthesis,
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`in vitro, and
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`culture cell, when compared with the referenced compound
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`‘of the prior art, and compounds having an identical
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`structure save for the selection of cyclopropyl, as
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`opposed to isopropyl substituent, for R5. This enhanced
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`activity could not be predicted on the basis of structure,
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`or information available to those of ordinary skill in the
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`art as of the effective filing date of this application.
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`Mylan Exhibit 1032, Page 3
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`Mylan Exhibit 1032, Page 3
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`All statements made herein of my own knowledge are
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`true, and all statements made on information and belief
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`are believed true.
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`I am aware that willful false
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`statements and the like are punishable by fine,
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`imprisonment or both, 18 U.S.C. §100l, and that such
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`willful false statements may jeopardize the validity of
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`the above-captioned patent application and any patent
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`issuing thereon.
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`FURTHER,
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`I SAYETH NOT.
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`May25, 1992
`D8“;
`
`{
`§:.!
`.
`l,{&a/
`Masaki Kitahara
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`Mylan Exhibit 1032, Page 4
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`Mylan Exhibit 1032, Page 4