Paper 14 Tel: Entered: June 15, 2015 UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD

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1 Paper 14 Tel: Entered: June 15, 2015 UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD DAIICHI SANKYO COMPANY, LIMITED, Petitioner v. ALETHIA BIOTHERAPEUTICS, INC., Patent Owner Case IPR Before MICHAEL P. TIERNEY, ERICA A. FRANKLIN, and SHERIDAN K. SNEDDEN, Administrative Patent Judges. SNEDDEN, Administrative Patent Judge. DECISION Institution of Inter Partes Review 37 C.F.R

2 I. INTRODUCTION Daiichi Sankyo Company, Limited ( Petitioner ) filed a Petition (Paper 2; Pet. ) to institute an inter partes review of claims 1 6, 8 11, and of US 8,168,181 B2 (Ex. 1001; the 181 patent ). Alethia Biotherapeutics, Inc. ( Patent Owner ) filed a Patent Owner Preliminary Response. Paper 10 ( Prelim. Resp. ). We have jurisdiction under 35 U.S.C The standard for instituting an inter partes review is set forth in 35 U.S.C. 314(a), which states that an inter partes review may not be instituted unless the information presented in the [Petition, taking into account any Preliminary Response,] shows that there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition. Upon consideration of the above-mentioned Petition and Preliminary Response we conclude that Petitioner has established that there is a reasonable likelihood that it will prevail with respect to at least one of the challenged claims. We authorize institution of an inter partes review as to claims 1 6, 8 11, and A. The 181 Patent (Ex. 1001) The 181 patent discloses methods of modulating osteoclast differentiation, which may be useful in the treatment of bone loss or bone resorption in patients suffering or susceptible of suffering from a certain conditions such as osteoporosis. Ex. 1001, 7:4 8, 7:

3 follows: Independent claims 1 and 15 of the 181 patent provide as 1. A method of impairing osteoclast differentiation in a mammal in need thereof, the method comprising administering an antibody or antigen binding fragment which specifically binds to human Siglec-15 (SEQ ID NO.:2) or murine Siglec-15 (SEQ ID NO.:108) to said mammal. 15. A method for inhibiting bone resorption comprising administering to a subject in need thereof, an antibody or antigen binding fragment which specifically binds to human Siglec-15 (SEQ ID NO.:2) or murine Siglec-15 (SEQ ID NO.:108). Challenged claims 2 6 and 8 11 depend from claim 1, either directly or indirectly. Challenged claims depend from claim 15, either directly or indirectly. B. Asserted Ground Petitioner contends that the priority documents of the 181 patent fail to provide adequate written description support and enablement for the subject matter of the challenged claims, and as such, the 181 patent is not entitled to a priority date earlier than April 16, Pet Petitioner contends that Hiruma 1 (Ex. 1002), thus, qualifies as prior art under 35 U.S.C. 102(a) and anticipates the subject matter of the claims. Id. at Yoshiharu Hiruma et al., WO 2009/048072, published on April 16, Ex An English translation of Ex is provided as Ex

4 II. ANALYSIS A. Claim Interpretation We interpret claims using the broadest reasonable construction in light of the specification of the patent in which [they] appear[]. 37 C.F.R (b); see also Office Patent Trial Practice Guide, 77 Fed. Reg. 48,756, 48,766 (Aug. 14, 2012). Under the broadest reasonable construction standard, claim terms are given their ordinary and customary meaning, as would be understood by one of ordinary skill in the art at the time of the invention. In re Translogic Tech., Inc., 504 F.3d 1249, 1257 (Fed. Cir. 2007). Absent claim language carrying a narrow meaning, the PTO should only limit the claim based on the specification... when [it] expressly disclaim[s] the broader definition. In re Bigio, 381 F.3d 1320, 1325 (Fed Cir. 2004). Although an inventor is indeed free to define the specific terms used to describe his or her invention, this must be done with reasonable clarity, deliberateness, and precision. In re Paulsen, 30 F.3d 1475, 1480 (Fed. Cir. 1994). The Petition does not require explicit construction of any claim term at this time. The parties do not dispute on this record that the claim terms should be given their plain and ordinary meaning and that no explicit construction is required at this stage. B. The 181 Patent Priority Claim To be entitled to the benefit of a parent application, one requirement is that the invention presently claimed must have been disclosed in the parent application in the manner provided by 35 U.S.C. 112, first paragraph. See 35 U.S.C. 120; In re Lukach, 442 F.2d 967, (CCPA 1971). An 4

5 ipsis verbis disclosure, however, is not necessary to satisfy the written description requirement. Vas-Cath Inc. v. Mahurkar, 935 F.2d 1555, 1563 (Fed. Cir. 1991). The disclosure need only reasonably convey to persons skilled in the art that the inventor had possession of the subject matter in question, even if every nuance of the claims is not explicitly described in the specification. Id.; see Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010). The test for written description is an objective inquiry into the four corners of the specification from the perspective of a person of ordinary skill in the art. Using this test, the invention must be described in a manner sufficient to demonstrate that the inventor actually invented the claimed invention. Ariad Pharm. Inc. v. Eli Lilly & Co., 598 F.3d 1336 (Fed. Cir. 2010). One shows that one is in possession of the invention by describing the invention, with all its claimed limitations, not that which makes it obvious. Lockwood v. Am. Airlines, Inc., 107 F.3d 1565, 1571 (Fed. Cir. 1997). Written description is a question of fact judged as of the relevant filing date. Falko-Gunter Falkner v. Inglis, 448 F.3d 1357, 1363 (Fed. Cir. 2006). The 181 patent issued from U.S. Application No. 12/580,943 ( the 943 application ) filed on October 16, 2009, which was filed as a continuation-in-part of U.S. Application No. 12/279,054, filed January 13, 2009, now U.S. Patent No. 7,989,160 (the Parent Application ), which is a national stage application of PCT/CA2007/ filed on February 13, Petitioner argues that the challenged claims of the 181 patent are entitled to a priority date no earlier than April 16, 2009, the publication 5

6 date of Hiruma, because the challenged claims lack adequate written description support in the Parent Application. Pet Specifically, Petitioner contends that the Parent Application fails to establish possession of the claimed subject matter because: 1) there is no example of a single therapeutic Siglec-15 antibody given in the specification of the Parent Application, yet the scope of the claims extends to any Siglec-15 antibody, including inhibitory antibodies. Id. at 14 (citing Ex , 16; Ex ). 2) while the Parent Application discloses the protein sequence for Siglec-15, there is no disclosure of any structural information regarding an antibody that binds this sequence and has the requisite activity set forth in the 181 patent claims. Id. at 15 (citing Ex , 17, 22, 23, 25). 3) as of the filing date of the 943 application, Siglec-15 was not known as an extracellular protein and was not sufficiently characterized such that an antibody targeting an extracellular domain and having the necessary therapeutic activity could be predictably made. Id. at (citing Ex ; Ex ). 4) the Parent Application provides a general disclosure regarding inhibitory compounds, but lacks any specific structural guidance necessary to show possession of antibodies that can specifically inhibit bone resorption or impair osteoclast differentiation. Id. at 2 Declaration of Dr. Paul R. Crocker. 6

7 19 21 (citing Ex , 17, 18; Ex , 8, 12, 13, 16, 21, 23). 5) the Parent Application fails to disclose an antibody that specifically binds to human Siglec-15 or murine Siglec-15. Id. at Petitioner further contends that the Parent Application fails to enable the claimed subject matter because it does not contain any teachings regarding how to make, without undue experimentation, an antibody that specifically binds Siglec-15 and impairs osteoclast differentiation or inhibits bone resorption, as required by the claimed methods. Id. at 25 (citing Ex , 28). Petitioner also contends that the Parent Application lacks any guidance for a method of treatment using anti-siglec-15 antibody. Id. at In response, Patent Owner requests that we use our discretion under 35 U.S.C. 325(d) to deny institution of an inter partes review because the issues raised in the Petition have been previously presented to the Patent Office. First, Patent Owner contends that the Office determined that U.S. Application No. 13/152,205 ( the 205 application ), a divisional of the Parent Application, fully satisfies the written description requirement. Prelim. Resp , The 205 application was filed as a divisional application of the Parent Application and issued with claims directed to antibodies or antigen binding fragments that bind to Siglec-15 and inhibit osteoclast differentiation or bone resorption activity of osteoclasts. Ex We note, however, that the scope of the claims in the 205 application differs significantly from the scope of the challenged claims. As such, we decline to use our discretion under 35 U.S.C. 325(d) to deny 7

8 institution of an inter partes review based on issues considered in the 205 application. Second, Patent Owner contends that the same 112 written description and enablement arguments have been previously presented to the Office multiple times during the prosecution of patent applications represented as owned by Petitioner that also disclose Siglec-15 antibodies. Prelim. Resp , We are not persuaded that the Office s consideration of 112 written description and enablement issues in an unrelated application (i.e., having a different disclosure) is relevant to the issues in this case. After careful review of both party s arguments, Petitioner has presented sufficient evidence, on the present record, to persuade us that the challenged claims of the 181 patent are entitled to a priority date no earlier than April 16, 2009, on the basis of lack of adequate written description support and/or enablement of the claim subject matter in the Parent Application. C. Asserted Grounds of Unpatentability 1. Anticipation of Claims 1 6, 8 11, and by Hiruma The Court of Appeals for the Federal Circuit summarized the analytical framework for determining whether prior art anticipates a claim as follows: If the claimed invention was described in a printed publication either before the date of invention, 35 U.S.C. 102(a), or more than one year before the U.S. patent application was filed, 35 U.S.C. 102(b), then that prior art anticipates the patent. Although 102 refers to the invention generally, the anticipation inquiry proceeds on a claim-by-claim 8

9 basis. See Hakim v. Cannon Avent Group, PLC, 479 F.3d 1313, 1319 (Fed.Cir.2007). To anticipate a claim, a single prior art reference must expressly or inherently disclose each claim limitation. Celeritas Techs., Ltd. v. Rockwell Int l Corp., 150 F.3d 1354, 1361 (Fed.Cir.1998). But disclosure of each element is not quite enough this court has long held that [a]nticipation requires the presence in a single prior art disclosure of all elements of a claimed invention arranged as in the claim. Connell v. Sears, Roebuck & Co., 722 F.2d 1542, 1548 (Fed.Cir.1983) (citing Soundscriber Corp. v. United States, 175 Ct.Cl. 644, 360 F.2d 954, 960 (1966) (emphasis added)). Finisar Corp. v. DirecTV Grp., Inc., 523 F.3d 1323, (Fed. Cir. 2008). We must analyze prior art references as a skilled artisan would. See Scripps Clinic & Res. Found. v. Genentech, Inc., 927 F.2d 1565, 1576 (Fed. Cir. 1991) (to anticipate, [t]here must be no difference between the claimed invention and the reference disclosure, as viewed by a person of ordinary skill in the field of the invention ). Petitioner contends that claims 1 6, 8 11 and of the 181 patent are anticipated by Hiruma. Pet Hiruma discloses the amino acid sequence of human Siglec-15 (SEQ ID NO: 2) and mouse Siglec-15 (SEQ ID NO: 4). Ex. 1023, 20:2 14. Hiruma discloses antibodies that specifically recognize human or mouse Siglec-15 and inhibit osteoclast formation and/or osteoclastic bone resorption. Id. at 5:1 20, 56:24 58:4, claim 33; Ex Examples 17, 19 26, and 35 of Hiruma disclose the results of experiments showing the inhibitory effect of Siglec-15 antibodies on osteoclast differentiation. Ex. 1023, 103:19 105:13, 106:17 119:4, 138:3 139:15; Ex Example 37 of Hiruma discloses the results of an experiment showing the use of a Siglec-15 9

10 antibody for inhibiting bone resorption. Ex.1023, 141:10 144:22. Hiruma further discloses administering a Siglec-15 antibody for the purposes of inhibiting or neutralizing the biological activity of Siglec-15 (i.e., the differentiation and/or maturation of osteoclasts). Id. at 56:24 59:7, 11:3 5, 5:1 7:1, 17:5 8, Fig. 36, claim 33; Ex ; Ex , In support of its assertion that Hiruma teaches each element of claims 1 6, 8 11, and 15 23, Petitioner sets forth the foregoing teachings of Hiruma and provides a detailed claim chart explaining how each claim limitation is disclosed. Pet Petitioner argues additionally that Hiruma was never substantively discussed, nor raised in any rejection, by the Examiner during the prosecution of the 181 patent. Id. at 57. Patent Owner does not dispute at this time that Hiruma discloses the limitations recited in the challenged claims. Upon review of Petitioner s analysis and supporting evidence, we determine that there is a reasonable likelihood that Petitioner would prevail in demonstrating the unpatentability of claims 1 6, 8 11, and as anticipated by Hiruma. III. CONCLUSION For the foregoing reasons, we determine that the information presented in the Petition demonstrates a reasonable likelihood that Petitioner would prevail in challenging claims 1 6, 8 11, and are unpatentable under 35 U.S.C. 102(a) over Hiruma. For the reasons given, it is IV. ORDER ORDERED that an inter partes review is hereby instituted with regard 10

11 to the following asserted ground: Claims 1 6, 8 11, and of the 181 patent under 35 U.S.C. 102(a) as anticipated by Hiruma; FURTHER ORDERED that pursuant to 35 U.S.C. 314(a), inter partes review of the ʼ181 patent is hereby instituted commencing on the entry date of this Order, and pursuant to 35 U.S.C. 314(c) and 37 C.F.R. 42.4, notice is hereby given of the institution of a trial. FURTHER ORDERED that the trial is limited to the ground listed in the Order. No other grounds are authorized. PETITIONER: Stephen B. Maebius Kristel Schorr Jeffrey N. Costakos FOLEY & LARDNER LLP smaebius@foley.com kschorr-ipr@foley.com jcostakos@foley.com PATENT OWNER: Fangli Chen Stephanie L. Schonewald Robert N. Sahr CHOATE HALL & STEWART LLP fchen@choate.com sschonewald@choate.com rsahr@choate.com Janique Forget Alethia Biotherapeutics Inc. janique.forget@alethiabio.com 11