11400024 (P.T.A.B. Feb. 23, 2017)

Ex Parte Chen

Patent Trial and Appeal BoardFeb 23, 2017

11400024 (P.T.A.B. Feb. 23, 2017)

United States Patent and Trademark Office UNITED STATES DEPARTMENT OF COMMERCE United States Patent and Trademark Office Address: COMMISSIONER FOR PATENTS P.O.Box 1450 Alexandria, Virginia 22313-1450 www.uspto.gov APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO. 11/400,024 04/06/2006 Shiuan Chen 054435-8027.US01 1085 34055 7590 02/27/2017 PERKINS COIE LLP - LOS General POST OFFICE BOX 1247 SEATTLE, WA 98111 -1247 EXAMINER CHONG, YONG SOO ART UNIT PAPER NUMBER 1627 NOTIFICATION DATE DELIVERY MODE 02/27/2017 ELECTRONIC Please find below and/or attached an Office communication concerning this application or proceeding. The time period for reply, if any, is set in the attached communication. Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the following e-mail address(es): patentprocurement @perkinscoie. com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte SHIUAN CHEN1 Appeal 2016-004754 Application 11/400,024 Technology Center 1600 Before JEFFREY N. FREDMAN, JOHN E. SCHNEIDER, and RYAN H. FLAX, Administrative Patent Judges. SCHNEIDER, Administrative Patent Judge. DECISION ON APPEAL This is an appeal under 35 U.S.C. § 134(a) involving claims to a composition for treating estrogen receptor mediated disorders which have been rejected as obvious. We have jurisdiction under 35 U.S.C. § 6(b). We reverse. STATEMENT OF THE CASE The Specification discloses “compounds that modulate the activity of estrogen receptors (ERa,P or ERa,b) and estrogen-related receptors (ERRa,P,y or ERRa,b,g) and methods for use of said compounds.” Spec. 13. 1 Appellant identifies the Real Party in Interest as City of Hope. Appeal Br. 2. Appeal 2016-004754 Application 11/400,024 Claims 1—10 and 39-55 are on appeal. Claim 1 is illustrative and reads as follows: 1. A composition for treating an estrogen receptor mediated disorder, comprising a therapeutically effective amount of a compound selected from the group consisting of Compound Nos. 1-9, 7-2, 7-4, 7-5, 7-7, 7-8, and 8-2 or a pharmaceutically acceptable salt thereof for treating an estrogen receptor mediated disorder; a pharmaceutically acceptable carrier, wherein the pharmaceutically acceptable carrier is selected from the group consisting of sugar, sugar alcohol, starch, cellulose or cellulose derivatives, tragacanth, malt, gelatin, talc, wax, oil, glycol, glycerol, ester, ethyl oleate, ethyl laurate, agar, magnesium hydroxide, aluminum hydroxide, alginic acid, isotonic saline, Ringer’s solution, sodium citrate, dicalcium phosphate, silicic acid, carboxymethylcellulose, alginates, polyvinyl pyrrolidone, disintegrating agents, calcium carbonate, alginic acid, silicates, solution retarding agents, paraffin, absorption accelerators, quaternary ammonium compound, wetting agents, acetyl alcohol, glycerol monostearate, kaolin, bentonite clay, lubricant, talc, calcium stearate, magnesium stearate, and sodium lauryl sulfate; and optionally, another therapeutic ingredient. 2 Appeal 2016-004754 Application 11/400,024 The claims stand rejected under 35 U.S.C. § 103(a) as unpatentable over Bombardelli2 in view of Dhar.3 THE REJECTION UNDER 35 U.S.C. § 103(a) Issue The issue with respect to this rejection is whether substantial evidence supports the Examiner’s conclusion that claims 1—10 and 39-55 would have been obvious. We limit our consideration of the merits of the appealed rejection to the elected species. See Ex parte Ohsaka, 2 USPQ2d 1460, 1461 (BPAI 1987). Thus, we read the claims as limited to the elected chalcone compound 1-9, which 2’,4’-dihydroxy-2,3-dimethylchalcone. (See Supplemental Response to Restriction Requirement filed on Nov. 16, 2009). The Examiner finds that Bombardelli teaches the use of chalcones of the general formula to treat neoplasms, menopausal disorders, and osteoporosis. Final Act. 4. The Examiner finds that Bombardelli teaches that the mechanism of action 2 Bombardelli et al., US 6,423,740 Bl, issued July 23, 2002 (“Bombardelli”). 3 Dhar and Lai, Chalcones. Condensation of Aromatic Aldehydes with Res acetophenone. II, 23 J. Organ. Chem. 1159 (1958) (“Dhar”). 3 Appeal 2016-004754 Application 11/400,024 of chalcones is believed to be linked to interaction of the compounds with type II estrogen receptors. Id. The Examiner finds that while Bombardelli does not teach the use of 2’,4’-dihydroxy-2,3-dimethylchalcone, Dhar teaches the synthesis of that compound. Final Act. 5. The Examiner concludes that it would have been prima facie obvious to a person of ordinary skill in the art, at the time the claimed invention was made, to substitute the chalcone, 2',4'- dihydroxy-2,3- dimethoxychalcone, as taught by Dhar, for the chalcones in the method of treating neoplasms, menopausal disorders, and osteoporosis, as taught by Bombardelli et al. A person of ordinary skill in the art would have been motivated to substitute the chalcone, 2',4'-dihydroxy-2,3- dimethoxychalcone because of chalcones taught by both Bombardelli and Dhar share a common structural core, 1,3- diphenyl-2-propene-l-one, with many of the same substituents. Therefore, one of ordinary skill in the art would expect a similar level of efficacy in the methods taught by Bombardelli. Final Act. 5. Appellant contends that Bombardelli does not teach using the specific chalcone claimed in that Bombardelli does not teach using a compound of formula A where R is OH. Appeal Br. 6—7. Appellant contends that the mere fact that Dhar discloses a compound that is structurally similar to those in Bombardelli is insufficient to provide a reason for the ordinary artisan to substitute the compound in Dhar into the composition of Bombardelli. Appeal Br. 7—8. Appellant argues that the art is highly unpredictable and that similar compounds with different substitutions have different effects. Appeal Br. 9-10; Reply Br. 6—12. Appellant also argues that the Examiner has not shown that all chalcones are equivalent. Appeal Br. 10. Appellant 4 Appeal 2016-004754 Application 11/400,024 argues that the Examiner has failed to give the preamble of the claims sufficient weight. Reply Br. 2—5. Findings of Fact FF1. Bombardelli teaches that [m]any naturally occurring flavonoids share structural features with chalcone and are referred to by the generic term “chalcones”. Also, certain flavonoids, including ones which are also classified as chalcones, have recently been demonstrated to have anti-cancer activity (Cancer Research, 48, 5754, 1988) and chemopreventive activity in some tumours (J. Nat. Prod., 53, 23, 1990). Bombardelli, col. 1,11. 20-27. FF2. Bombardelli also teaches that “some natural or synthetic chalcones . . . have proved to have a significant antiproliferation activity on a variety of different cell lines.” Bombardelli, col. 1,11. 36-41. FF3. Bombardelli teaches that [t]he action in vivo of these polyphenol substances is certainly much more complicated. All these compounds are generally characterized by an almost complete insolubility in water and, in vivo, by a very poor bioavailability linked to a rapid metabolism of phenols and a marked affinity for lipids and proteins. Bombardelli, col. 1,11. 46—51. FF4. Bombardelli discloses the use of compounds of the general formula 5 Appeal 2016-004754 Application 11/400,024 Wherein Ar represents phenyl, which may be unsubstituted or substituted by one, two or three substituents independently selected from Cl, Br, F, —OMe, NO2, CF3, CN, Cm lower alkyl (preferably methyl), —NMe2, —NEt2, —SCH3, —NHCOCH3; 2-thienyl; 2-furyl; 3-pyridyl; 4-pyridyl or 3-indolyl; and R represents —OCH2Ri, in which Ri is selected from—CH=CMe2, —CMe=CH2, or —C=CH; with the proviso that where Ar represents phenyl, R is other than 3-methyl-2-butenyloxy. Within this class, preferably Ar is selected from unsubstituted phenyl, 3-pyridyl, 4-pyridyl and 3-indolyl. Particularly preferred are compounds wherein R represents —OCH^-CH=CMe2, —OCH^-CMe=CH2, or—OCH2— C=CH. Bombardelli, col. 2,11. 1—24. FF5. Dhar discloses the manufacture of 2 ’ ,4 ’-dihydroxy-2,3 - dimethoxychalcone. Dhar 1159, col. 2. FF6. Dhar teaches that the “chalcone is very soluble in acetone, ethyl acetate and pyridine, moderately soluble in other common organic solvents and sparingly soluble in petroleum ether and water.” Dhar 1160 col. 1. Principles of Law “In addition to structural similarity between the compounds, a prima facie case of obviousness also requires a showing of ‘adequate support in the prior art’ for the change in structure.” Takeda Chem. Indus., Ltd. v. 6 Appeal 2016-004754 Application 11/400,024 Alphapharm Pty., Ltd., 492 F.3d 1350, 1356 (Fed. Cir. 2007) (quoting In re Grabiak, 769 F.2d 729, 731-732 (Fed. Cir. 1985). Analysis Substantial evidence supports the Appellant’s position. While the Examiner has shown that the compound in Dhar is structurally similar to those disclosed in Bombardelli, the Examiner has not put forth a persuasive explanation as to why one skilled in the art would make the proposed substitution or would otherwise combine the chalcone of Dhar with a member of the list of pharmaceutically acceptable carriers recited in the claims because Dhar provides no specific use for the chalcone. The Examiner argues that Bombardelli teaches that all chalcones having a base structure similar to that in Bombardelli can be used in Bombardelli’s invention. Ans. 6. We are not persuaded. As the Appellant points out, Bombardelli teaches that only some chalcones exhibit the desired characteristics and that even then, performance in vivo can be different from performance in vitro. FF1—3; Appeal Br. 9-10; Reply Br. 5. In addition, as Appellant has explained, Bombardelli teaches that different substitutions at the R group and different Ar groups will have different properties. Reply Br. 6—11. This contradicts the Examiner’s position that Bombardelli teaches that all chalcones with a similar base structure could be used in the practice of Bombardelli’s invention. We conclude that the evidence of record does not support the Examiner’s conclusion that claim 1 would have been obvious over Bombardelli combined with Dhar. 7 Appeal 2016-004754 Application 11/400,024 SUMMARY We reverse the rejection under 35 U.S.C. § 103(a). REVERSED 8