10508958 (P.T.A.B. Jul. 29, 2013)

Ex Parte Naoe et al

Patent Trial and Appeal BoardJul 29, 2013

10508958 (P.T.A.B. Jul. 29, 2013)

UNITED STATES PATENT AND TRADEMARK OFFICE ____________ BEFORE THE PATENT TRIAL AND APPEAL BOARD ____________ Ex parte YOSHINORI NAOE and SUSAN E. BATES ____________ Appeal 2011-011328 Application 10/508,958 Technology Center 1600 ____________ Before JEFFREY N. FREDMAN, ULRIKE W. JENKS, and JOHN G. NEW, Administrative Patent Judges. JENKS, Administrative Patent Judge DECISION ON APPEAL This is an appeal under 35 U.S.C. § 134 involving claims directed to a method of treating kidney cancer with a histone deacetylase inhibitor. The Patent Examiner has rejected the claims as obvious and under nonstatutory obviousness-type double patenting. We have jurisdiction under 35 U.S.C. § 6(b). We reverse. App App App appe 1 Hid Nove 126- 2 Gu 3 Hir Prod 310 4 Yo eal 2011-0 lication 10 Claims 1 endix of th al, and rea 1. A met thereof, a compo or a salt The Exa I. cl N II. cl ob in enori Nak l Histone 133 (1998 y Georges otsugu Ue uced by C (1994). shinori Na 11328 /508,958 ST -5 and 7 a e Appeal B ds as follo hod of tre which com und of the thereof to miner has aims 1-5 a akajima1 in aims 1-5 a viousness view of G ajima et a Deacetyla ). et al., US da et al., F hromobac oe et al., U ATEMEN re on appe rief. Cla ws: ating kidne prises adm formula ( said mamm rejected th nd 7 under view of G nd 7 stand -type doub eorges in l., FR9012 se Inhibito 2002/0065 R901228, terium vio S 7,314,8 2 T OF TH al, and ca im 1 is rep y cancer i inistering I) al. e claims a 35 U.S.C eorges2 a rejected u le patentin further vie 28, a Pote r, 24 EXPE 282 Al, p A Novel A laceum No 62 B2, iss E CASE n be found resentativ n a mamm an effecti s follows: . § 103(a) nd Ueda3 nder the d g over cla w of Ueda nt Antitum RIMENTAL ublished M ntitumor B . 968, 47 ued Jan. 1 in the Cla e of the cl al in need ve amoun as unpaten (Ans. 11); octrine of ims 11-13 (Ans. 7); or Antibio CELL RE ay 30, 20 icyclic D J. ANTIBIO , 2008. ims aims on t of table over of Naoe4 tic, Is a SEARCH 02. epsipeptid TICS 301- e Appeal 2011-011328 Application 10/508,958 3 III. claims 1-5 and 7 stand provisionally rejected under the doctrine of obviousness-type double patenting over claims 48, 50, and 55 of co-pending application No. 11/064,2925 (now issued as US 7,951,780 B2) in view of Georges in further view of Ueda (Ans. 5); IV. claims 1-5 and 7 stand provisionally rejected under the doctrine of obviousness-type double patenting over claims 45 and 60 of co-pending application No.10/486,8336 (now issued as US 8,470,783 B2) in view of Georges (Ans. 9). I. The Issue: Obviousness over Nakajima, Georges, and Ueda The Examiner takes the position that Nakajima disclosed “the compound of formula I and II as an inhibitor of intracellular histone deacetylase activity” (Ans. 11), while Ueda disclosed the use of these compounds as “anti-tumor agents against human tumor cell lines both in vitro and in vivo” (id. at 12). According to the Examiner Georges disclosed that “histone deacetylase inhibitors treat[] prostate and kidney cancer.” (Id. at 10.) The Examiner concludes because Georges disclosed that “histone deacetylase inhibitors are administered to a human in need of treatment of cancers such as kidney cancer” (id.) it would have been obvious to use the compound of Nakajima to suppress “the growth of cancerous tumors of the kidney in vivo in a human because Ueda et al. teaches the applicant’s compounds as anti-tumor agents against human tumor cell lines both in vitro 5 Yoshinori Naoe et al., US 7,951,780 B2, issued May 31, 2011. 6 Yuka Sasakawa et al., US 8,470,783 B2, issued Jun. 25, 2013. App App and i expe the c in th conc claim Find (HD This FR9 activ deac proli and G of tr comp eal 2011-0 lication 10 n vivo.” ( ct a histon ompound e kidney.” The issu lusion that s obvious ings of Fa FF 1. Th AC) havin compound 01228). T ity . . . pa etylase inh FF 2. N feration of 2/M phas ansplanted FF 3. U ound FR9 11328 /508,958 Id.) The E e deacetyl will also tr (Id.) e is: Does the comb ? ct e Specific g formula “is a ster hese comp rticularly F ibitory ac akajima di tumor cel es . . . . In tumors in eda disclo 01228. S xaminer r ase inhibit eat kidney the evide ination of ation prov (II), depic eoisomer ( ounds hav R901228 tivity.” (S sclosed th ls in vitro addition, F mice.” (N sed in vivo pecifically 4 easons tha or to funct cancer an nce of reco Nakajima, ides an in ted below hereinafte e a potent has an eve pec. p. 8, l at “FR901 by arrestin R901228 akajima 1 and in vit , cell lines t the ordin ion “by th d suppres rd suppor Georges, hibitor of h : r to be als histone de n more po . 22 to p. 9 228 strong g cell cyc greatly su 26; Ans. 1 ro antitum A549 (a h ary artisan e same me s cancerou t the Exam and Ueda istone de o referred acetylase tent histo , l. 2.) ly inhibite le transitio ppressed t 1.) or activity uman lun would chanism, s tumors iner’s render the acetylase to as inhibitory ne d n at G1 he growth with g Appeal 2011-011328 Application 10/508,958 5 adenocarcinoma) and MCF-7 (a human mammary adenocarcinoma) were not only tested in vitro for antitumor activity but also tested in vivo using a subrenal capsule assay. (Ueda 303-304.) FF 4. Georges disclosed that “(1-oxo-1,2,3,4-tetrahydro- naphthalen- 2-yl)-alkanoic acid hydroxamides possess anti-cell-proliferation properties which arise from their HDAC [histone deacetylase] inhibitory activity.” (Georges 1: ¶0016.) FF 5. Georges disclosed that: (1-oxo-1,2,3,4-tetrahydro-naphthalen-2-yl)-alkanoic acid hydroxamide derivative . . . for use in a method of treatment of the human or animal body by therapy. . . . It is in addition expected that a derivative of the present invention will possess activity against a range of leukemias, lymphoid malignancies and solid tumors such as carcinomas and sarcomas in tissues such as the liver, kidney, prostate and pancreas. (Georges 3: ¶0036; Ans. 12.) Principle of Law “In rejecting claims under 35 U.S.C. § 103, the examiner bears the initial burden of presenting a prima facie case of obviousness. Only if that burden is met, does the burden of coming forward with evidence or argument shift to the applicant.” In re Rijckaert, 9 F.3d 1531, 1532 (Fed. Cir. 1993) (citations omitted). While the analysis under 35 U.S.C. § 103 allows flexibility in determining whether a claimed invention would have been obvious, KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 418 (2007), it still requires showing that “there was an apparent reason to combine the known elements in the fashion claimed by the patent at issue.” Id. “We must still be careful not to Appeal 2011-011328 Application 10/508,958 6 allow hindsight reconstruction of references to reach the claimed invention without any explanation as to how or why the references would be combined to produce the claimed invention.” Innogenetics, N.V. v. Abbott Labs., 512 F.3d 1363, 1374 n.3 (Fed. Cir. 2008). Analysis Appellants contend that neither “[t]he Examiner nor the art provides any reasonable basis to conclude that the mere presence of the same mechanism (HDAC inhibition) portends of a reasonable basis to conclude anything with respect to efficacy.” (App. Br. 13.) Appellants contend that obvious to try is not applicable the context of cancer therapy, “the field of chemotherapeutics is a wasteland of failed attempts based on this similar logic” (Reply Br. 5). We find that the Appellants have the better position. Based on the evidence before us we are not persuaded that the Examiner has established a prima facie case. We agree with the Examiner’s finding that the specific histone deacetylase inhibitor was known (FF 2) and it was also known that the compound can be administered to an animal in sufficient quantities to cause a reduction in tumor load of lung and breast tissue transplanted into a mouse (FF 3). What was not known was the effect of the compound on kidney tumor cells. Georges disclosed a different type of histone deacetylase inhibitor and speculates that histone deacetylase inhibitors could be effective to treat numerous cancers including kidney cancer (FFs 4, 5). According to the Examiner it would be expected that all histone deacetylase inhibitors function “by the same mechanism, [thus] the compound will also treat kidney cancer and suppress cancerous tumors in the kidney.” (Ans. Appeal 2011-011328 Application 10/508,958 7 12.) The combination of references, as acknowledged by the Examiner (id. at 15), would make it obvious to try applying the depsipepetide for the treatment of kidney cancer (FFs 2-5). Although we recognize that “[o]bviousness does not require absolute predictability of success ... all that is required is a reasonable expectation of success.” In re Droge, 695 F.3d 1334, 1338 (Fed. Cir. 2012) (quoting In re Kubin, 561 F.3d 1351, 1360 (Fed. Cir. 2009) (citing In re O'Farrell, 853 F.2d 894, 903-04 (Fed. Cir. 1988)). In the realm of cancer treatment, however, there is insufficient predictability in the art for there to be a reasonable expectation that administering a compound to an animal that is effective for one type of cancer would reasonably provide an expectation of success for the treatment of kidney cancer as claimed. On this record, we conclude that the Examiner has not met the burden of showing a prima facie case of obviousness. II. The Issue: Obvious-Type Double Patenting over US 7,314,862 The rejections under the judicially created doctrine of obviousness- type double patenting in the Answer is moot in view of the terminal disclaimer with respect to US 7,314,862 that was filed and approved July 24, 2013. III. The Issue: Obvious-Type Double Patenting over Appl. No. 11/064,292 Appellants request reversal of this rejection because the claims at issue are no longer in the ‘292 application (App. Br. 19-20). We note that claims 48, 50, 55-58, 63 and 64 of Application 11/064,292 have been canceled by the Examiner’s amendment of Appeal 2011-011328 Application 10/508,958 8 January 20, 2011. The remaining claims in Appl. No. 11/064,292 (now issued as U.S. Pat. No. 7,951,780 B2) are directed to “[a] method for treating prostate cancer consisting of: administering a compound of formula (I) and docetaxel to a subject in need thereof; wherein: the compound of formula (I) is administered before the docetaxel; and the compound of formula (I)” (Claim 1) (emphasis added). At best Georges suggested kidney and prostate cancers as potential targets for the specifically recited histone deacetylase inhibitor that differs from the presently claimed inhibitor (FFs 4, 5). The Examiner concludes that the ordinary artisan would be motivated to treat cancer using formula (I) without doxorubicin because “compound of formula I is known to treat cancer by being a histone deacetylase inhibitor” (Ans. 7). What is missing from the Examiner’s analysis with respect to the combination of Ueda and Georges is a showing that there is an expectation that a treatment protocol for prostate cancer would also work in kidney cancer. Accordingly we reverse this rejection. IV. The Issue: Obvious-Type Double Patenting over Appl. No. 10/486,833 Appellants contend that there “is nothing obvious about a method of treating kidney cancer and/or a method of suppressing growth of a cancerous tumor of the kidney in vivo in mammals (the claimed invention) from the claims of US 10/486,833 drawn to a method of treating prostate cancer, or vice versa.” (App. Br. 21; Reply Br. 22.) We find that the Appellants have the better position. At best Georges suggested that kidney and prostate cancers as potential targets for the specifically recited histone deacetylase inhibitor (FFs 4, 5). We are not Appeal 2011-011328 Application 10/508,958 9 persuaded by the Examiner’s reason that “[s]ince the applicant's compound is a histone deacetylase inhibitor, then by the same mechanism, the compound [of formula I] will also treat kidney cancer and suppress cancerous tumors in the kidney.” (Ans. 11.) What is missing from the Examiner’s analysis with respect to Georges is a showing that there is an expectation that a treatment protocol that is effective for prostate cancer would also work in kidney cancer. Accordingly, we reverse this rejection. SUMMARY We reverse the rejection of claims 1-5 and 7 under 35 U.S.C. § 103(a) over Nakajima in view of Georges and Ueda. The rejection of claims 1-5 and 7 on the grounds of obviousness-type double patenting over claims 11-13 of Naoe in view of Georges in further view of Ueda is moot in view of the terminal disclaimer over US 7,314,862 filed and approved on July 24, 2013. We reverse the rejection of claims 1-5 and 7 on the grounds of obviousness-type double patenting over claims 48, 50, and 55 of co-pending application No. 11/064,292 (now issued as U.S. Pat. No. 7,951,780 B2) in view of Georges in further view of Ueda. We reverse the rejection of claims 1-5 and 7 on the grounds of obviousness-type double patenting over claims 45 and 60 of co-pending application No.10/486,833 (now issued as US 8,470,783 B2) in view of Georges. Appeal 2011-011328 Application 10/508,958 10 TIME PERIOD FOR RESPONSE No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § 1.136(a). REVERSED cdc