Lichter et al.v.Meyer

Patent Trial and Appeal BoardJan 26, 2017

13848636 (P.T.A.B. Jan. 26, 2017)

BoxInterferences@uspto.gov Tel: 571-272-9797 Entered: January 26, 2017 UNITED STATES PATENT AND TRADEMARK OFFICE _______________ BEFORE THE PATENT TRIAL AND APPEAL BOARD _______________ OTONOMY, INC. and THE REGENTS OF THE UNIVERSITY OF CALIFORNIA (Inventors: Jay Lichter, Andrew M. Trammel, Fabrice Piu, Qiang Ye, Luis A. Dellamary, Carl Lebel, and Jeffrey P. Harris) Junior Party (Application 13/848,636), v. AURIS MEDICAL, AG (Inventor: Thomas Meyer) Senior Party (Patent 9,066,865). Patent Interference No. 106,030 (JTM) (Technology Center 1600) Before RICHARD E. SCHAFER, JAMES T. MOORE, and DEBORAH KATZ, Administrative Patent Judges. MOORE, Administrative Patent Judge. JUDGMENT 37 C.F.R. § 41.127 Interference 106,030 Judgment 2 We have granted Auris Motion 1 for benefit. We have also granted-in-part 1 Otonomy Motion 2, seeking a determination that Auris claims 1-9 are unpatentable. 2 In view of the foregoing, it is— 3 ORDERED that judgment be entered against Junior Party Otonomy for count 4 1 (Paper 1); 5 FURTHER ORDERED that claims 38, 43, and 46-50 of Junior Party 6 Otonomy’s involved US Application 13/848,636 be FINALLY REFUSED, 35 7 U.S.C. § 135(a); 8 FURTHER ORDERED that claims 1-8 of Senior Party Auris’ involved US 9 Patent 9,066,865 be CANCELED, 35 U.S.C. § 135(a); 10 FURTHER ORDERED that a copy of this judgment be entered in the 11 administrative records of the involved patent and application; and 12 FURTHER ORDERED that a party seeking judicial review timely serve 13 notice on the Director of the United States Patent and Trademark Office. 37 C.F.R. 14 §§ 90.1 and 104.2. 15 16 17 NOTICES: 18 Any agreement or understanding between parties to an interference, including any 19 collateral agreements referred to therein, made in connection with or in 20 contemplation of the termination of the interference, shall be in writing and a true 21 copy thereof filed in the Patent and Trademark Office before the termination of the 22 interference as between the said parties to the agreement or understanding. 35 23 U.S.C. 135(c); see also Bd. R. 205 (settlement agreements). 24 25 Attention is directed to 11 Biogen Idec MA, Inc., v. Japanese Foundation for 26 Cancer Research, 785 F.3d 648, 654–57 (Fed. Cir. 2015) (cert. denied 2016 WL 27 1078942, Mar 21, 2016) (determining that pre-AIA § 146 review was eliminated 28 for interference proceedings declared after September 15, 2012). 29 Interference 106,030 Judgment 3 Attorney for Otonomy, Inc.: Michael T. Rosato Michael J. Hostetler Richard Torczon Wilson Sonsini Goodrich & Rosati Email: mrosato@wsgr.com Email: mhostetler@wsgr.com Email: rtorczon@wsgr.com Attorney for Auris Medical, AG: Michael Tuscan, Ph.D. Bonnie Weiss McLeod, Ph.D. Cooley, LLP Email: mtuscan@cooley.com Email: bweissmcleod@cooley.com Email: zpatdcdocketing@cooley.com BoxInterferences@uspto.gov Tel: 571-272-9797 Entered: January 26, 2017 UNITED STATES PATENT AND TRADEMARK OFFICE _______________ BEFORE THE PATENT TRIAL AND APPEAL BOARD _______________ AURIS MEDICAL, AG (Inventor: Thomas Meyer) Junior Party (Patent 9,066,865), v. OTONOMY, INC. and THE REGENTS OF THE UNIVERSITY OF CALIFORNIA (Inventors: Jay Lichter, Andrew M. Trammel, Fabrice Piu, Qiang Ye, Luis A. Dellamary, Carl Lebel, and Jeffrey P. Harris) Senior Party (Application 13/848,636). Patent Interference No. 106,030 (JTM) (Technology Center 1600) Before RICHARD E. SCHAFER, JAMES T. MOORE, and DEBORAH KATZ, Administrative Patent Judges. MOORE, Administrative Patent Judge. DECISION ON MOTIONS 37 C.F.R. § 41.125 I. Background 1 An interference was declared under 35 U.S.C. § 135(a) on July 20, 2015. 2 Paper 1. Auris Medical, AG (“Auris”) was assigned the status of junior party with 3 an initial application filing date of June 27, 2014. Otonomy, Inc. and the Regents 4 Interference 106,030 Motions Decision 2 of the University of California (“Otonomy”) was assigned the status of senior party 1 with an initial application filing date of March 21, 2013. 2 The interference count is claim 1 of Patent 9,066,865. For ease of reference, 3 that claim is reproduced below: 4 1. A method of treating a middle or inner ear disease comprising 5 intratympanically administering to a patient in need thereof a controlled 6 release composition comprising a pharmaceutically active agent and a 7 thermosetting polymer; wherein the pharmaceutically active agent is 8 selected from antibiotics and is suspended in the composition, and the 9 thermosetting polymer has a gelation temperature of at least about 15° C, 10 11 wherein the thermosetting polymer is poloxamer 407 and is present at a 12 concentration of about 20% (w/w), and 13 14 wherein the antibiotic is fluoroquinolone. 15 Following a conference call on September 9, 2015, the following motions 16 were authorized in an order dated September 11, 2015 (Paper 29): 17 Auris Motion 1 - for benefit of U.S. Application 11/992,632, filed 26 March 18 2008 and International Application PCT/EP2005/010478, filed 28 September 19 2005. 20 Auris Motion 2 - for judgment against Otonomy based on anticipation under 21 35 U.S.C. § 102(b) by WO 2007/038949 A1 published 12 April 2007. 22 Otonomy Motion 1 and Otonomy Motion 2 (filed jointly) – (1) motion for 23 judgment of unpatentability under 35 U.S.C. § 112 (a) because the written 24 description portion of the Specification of the involved patent allegedly lacks full-25 scope support for a method of using a controlled release composition 1 comprising 26 a pharmaceutically active agent . . . wherein the pharmaceutically 2 active agent is 27 selected from antibiotics and is suspended in the composition; (2) unpatentability 28 Interference 106,030 Motions Decision 3 under 35 U.S.C. § 112 (a), because the written description portion of the 1 Specification of the involved patent lacks full-scope support for treating a middle 2 or inner ear disease with fluoroquinolone. 3 Otonomy Motion 6 – for benefit of application 13/645,126, filed 4 October 4 2012; application 12/506,127, filed 20 July 2009; application 12/466,310, filed 14 5 May 2009; provisional application 61/140,033, filed 22 December 2008; 6 provisional application 61/101,112, filed 29 September 2008; provisional 7 application 61/094,384, filed 4 September 2008; and provisional application 8 61/083,871, filed 25 July 2008. 9 The authorized motions, oppositions, and replies, along with exhibit lists and 10 the exhibits have been filed. The motions are ready for decision. We find that the 11 record is complete enough to obviate the need for oral argument. Otonomy’s 12 request for Oral Argument (Paper 144) is therefore denied. 13 II. Auris Motion 2 - Anticipation 14 We take up Auris Motion 2 concerning anticipation first. Even were we to 15 give benefit to Otonomy’s earliest requested date, WO2007/038949 has the 16 potential to anticipate Otonomy’s claims. 17 On November 9, 2015, Auris filed Auris Motion 2 for judgment under 35 18 U.S.C. § 102(b) (Paper 96)(substitute). On February 12, 2016 Otonomy filed 19 Otonomy Opposition 2 (Paper 117). Finally, on March 18, 2016, Auris filed its 20 Reply 2 (Paper 133). 21 Otonomy’s involved claims are 38, 43, and 46-50 of US Patent Application 22 No. 13/848,636 filed March 21, 2013. Claim 38 is reproduced below from Paper 23 11. 24 Interference 106,030 Motions Decision 4 38. A method of treating a middle or inner ear disorder comprising 1 intratympanically administering to an individual in need thereof a controlled 2 release composition comprising a pharmaceutical agent and a thermosetting 3 polymer; wherein the pharmaceutical agent is selected from an uncoated 4 antibacterial agent and is suspended in the composition, and the 5 thermosetting polymer has a gelation temperature of between about 12ºC to 6 about 20ºC, wherein the middle or inner ear disorder is a viral or bacterial 7 infection, wherein the thermosetting polymer is poloxamer 407 and has a 8 concentration of about 20% (w/w), and wherein the antibacterial agent is 9 fluoroquinolone. 10 11 Exhibit 2006 is WO 2007/038949 A1, was filed by Auris, and published in 12 the English language April 12, 2007. 13 A person shall be entitled to a patent unless “the invention was patented or 14 described in a printed publication in this or a foreign country or in public use or on 15 sale in this country, more than one year prior to the date of the application for a 16 patent in the United States.” 35 U.S.C. § 102 (b). 17 There is no dispute that Exhibit 2006 (also referred to as WO ‘949 or PCT 18 ‘949) was published on April 12, 2007, more than one year before the earliest 19 possible priority date of Otonomy. Auris Motion 2, 2, Ex. 2006, 1. 20 Claim 38 has several elements, which we break out in lettered sections 21 below to assist in the analysis of whether the claim is anticipated (paragraphing 22 and bracketed matter added)– 23 [a][Preamble] A method of treating a middle or inner ear disorder 24 comprising 25 [b] intratympanically administering to an individual in need thereof 26 [c] a controlled release composition comprising [d] a pharmaceutical agent 27 and [e] a thermosetting polymer; wherein 28 [f] the pharmaceutical agent is selected from an uncoated antibacterial agent 29 and 30 Interference 106,030 Motions Decision 5 [g] [the pharmaceutical agent] is suspended in the composition, and 1 [h] the thermosetting polymer has a gelation temperature of between about 2 12ºC to about 20ºC, wherein 3 [i] the middle or inner ear disorder is a viral or bacterial infection, wherein 4 [j] the thermosetting polymer is poloxamer 407 and has a concentration of 5 about 20% (w/w), and wherein 6 [k] the antibacterial agent is fluoroquinolone. 7 We find that the record establishes the following as regards the individual 8 elements of claim 38: 9 [a] WO ‘989 describes compositions for the treatment of disorders of the 10 inner ear. Ex. 2006, Title, p. 1, ¶ 1. 11 [b] WO ‘989 describes transtympanic or intratympanic injection where the 12 medication is injected through the tympanic membrane into the middle ear. Ex. 13 2006, p. 2, ¶ 1. See also pp 18-19 and 25–26. 14 [c] WO ‘989 describes controlled release of the drug over an extended 15 period of time such as hours, days or weeks to improve its diffusion into the inner 16 ear. Ex. 2006, p. 2, ¶ 2. See also p. 12, ¶ 3 describing release formulations to last 17 from hours to weeks. 18 [d] WO ‘989 describes numerous pharmaceutical agents. Ex. 2006, Title, p. 19 1, ¶ 2. 20 [e] WO’989 describes thermosetting gel polymers. Ex. 2006, p. 10, ¶ 2. 21 [c][d][e] As to these elements together forming a release composition, WO 22 ‘989 describes that the thermosetting gel polymers as implants where soluble drugs 23 are released by diffusion through the polymer. Ex. 2006, pp. 10–11. 24 [f] WO ‘989 describes antibiotics. Ex. 2006, p. 17, ¶ 3. 25 Interference 106,030 Motions Decision 6 [g] WO ‘989 describes medicaments which are dissolved, emulsified, or 1 dispersed. Ex. 2006, p. 13, ¶ 5. A gel holding microspheres “suspended” in the 2 gel also is described. Id., p. 14, ¶ 3. 3 [h] WO ‘989 describes a thermosetting poloxamer polymer dissolved at 4 concentrations above 20% w/w which remain fluid at low temperatures, but form 5 highly viscous, solid-like implants upon an increase in temperature to around 6 15 °C. Ex. 2006, p. 10, ¶ 3–4. 7 [i] WO ‘989 describes known art for the treatment of bacterial or viral 8 infection in the middle or inner ear. Ex. 2006, p. 4, ¶ 1–2. 9 [j] WO ‘989 describes the use of 20% Lutrol F127 (BASF) poloxamer. Ex. 10 2006, p. 25, ¶ 2. Lutrol F 127 is a trade name for poloxamer 407. Ex. 2010, p. 2. 11 [k] WO ‘989 describes the use of fluoroquinolone. Ex. 2006, p. 17, ¶ 3. 12 Thus, it becomes apparent to us that each of the claimed elements is at least 13 found within the description of WO ‘949. We observe that although individual 14 elements are described as noted above, WO ‘949 nonetheless describes numerous 15 different embodiments of medicaments and systems for delivery within its 16 description. 17 Otonomy opposes. Paper 117. Moreover, Otonomy asserts that the Board 18 should enter judgment against Auris that it is not entitled to an effective filing date 19 before 2015, and accordingly its claims should be held unpatentable under the 20 presumption of Board R. 207(c)1. Paper 117, 1. 21 Otonomy’s principal argument is that WO ‘949 does not teach an enabled 22 embodiment with all the limitations of Otonomy claim 38 as arranged. Id., 2. 23 1 37 C.F.R. 41.207(c). Interference 106,030 Motions Decision 7 Otonomy is correct in that specific statement. There are embodiments in WO ‘949 1 which describe different arrangements of each element. But we find that there is no 2 discernable single embodiment which teaches all of the claim elements as 3 arranged. 4 But our analysis does not end there. Even though a reference describes a 5 number of options, anticipation may still be found. See In re Petering, 301 F.2d 6 676 (CCPA 1962), and In re Schaumann, 572 F.2d 312 (CCPA 1978), both of 7 which held that anticipation was justified based on the number of options described 8 in prior art references (Petering – 20; Schaumann – alkyl radical embraces limited 9 numbers). There is, of course, some danger that one may stray into the realm of 10 obviousness and even hindsight if too many choices are to be made. 11 Ex. 2006 describes compositions for the treatment of inner ear disorders. 12 Otonomy challenges that Ex. 2006 is not directed to middle ear disorders, to using 13 any antibiotic, specifically a fluoroquinolone, to treat middle or inner ear diseases, 14 administering a controlled release composition comprising a thermosetting 15 polymer, suspending an antibiotic in a composition comprising a thermosetting 16 polymer, or the antibiotic in suspension to be uncoated. Paper 117, 2. 17 The difficulty we see with this statement is that WO ‘989 does in fact 18 individually teach these elements, and in the structure of a composition for 19 treatment of inner ear diseases. The dispositive question in our minds is whether 20 these elements are taught sufficiently such that one of ordinary skill in the art 21 would see a description of the instantly claimed invention, given the totality of the 22 description of the reference. 23 Interference 106,030 Motions Decision 8 WO ‘989 describes pharmaceutical compositions for the treatment of inner 1 ear disorders. Ex. 2006, Title. The specific framework of the description of WO 2 ‘989 is that inner ear disorders are treated by a composition injected into the 3 middle ear and the compositions are sustained release. Id., p. 4, ¶ 3. The 4 composition includes a pharmaceutical and a biocompatible polymer. Id., p. 4, ¶ 4. 5 In terms of selecting a pharmaceutical, there are potentially infinite 6 pharmaceuticals available. However, of those specifically named in Ex. 2006, the 7 list includes ketamine (p. 6) and its isomers; and “antibiotics, e.g., 8 fluoroquinolones, anti-inflammatory agents, e.g., steroids, cortisone, analgesics, 9 antipyrine, benzocaine, procaine, antioxidants, e.g. methionine, N-acetylcysteine, 10 trolox, neurotrophins, e.g. GDNF or BDNF, anti-apoptotic or anti-necrotic agents, 11 e.g. leupeptin, caspase inhibitors, etc.” (p. 17).” 12 In terms of delivery vehicles, WO ‘989 describes, inter alia, that the 13 composition can be solid, liquid, semi-solid, or gel-like. Ex. 2006, p. 7. The 14 delivery vehicle can be a solution, suspension, or thermosetting gel. Id. Polymers 15 said to be suitable include poly(esters) based on polylactide (PLA), polyglycolide 16 (PGA), polycaprolactone (PCL) and their copolymers, polyhydroxyalkanoates of 17 the PHB-PHV class, additional polyesters and natural polymers, particularly, 18 modified polysaccharides, e. g. starch, cellulose and chitosan. Id. at 8. 19 WO ‘989 describes a few examples – ketamine in hyaluronic acid gel (p. 20 20), and ketamine in 20% poloxamer gel (p. 25). 21 In terms of testimony provided on the point, Auris has submitted the 22 declaration of Cory Berkland, Ph.D. (Exhibit 2013). Dr. Berkland is a Professor of 23 Interference 106,030 Motions Decision 9 Pharmaceutical Chemistry at the University of Kansas. Ex. 2013, 1. We consider 1 him to be qualified to testify as to the subject matter of this interference. Id., 1-3. 2 The pertinent substance of his testimony is that WO ‘989 describes the 3 subject matter of the Otonomy claims to a person of ordinary skill in the art. Id., 4 7, ¶ 26. Initially, we accept the testimony of Dr. Berkland that uncoated 5 fluoroquinone would normally be utilized in intratympanic injection. Ex. 2013, ¶ 6 35. 7 Because of its description of a thermosetting polymer as a delivery method, 8 Dr. Berkland finds that one of ordinary skill in the art would conclude that the 9 thermosetting polymers can be used with any of the active agents in the 10 specification. Id., 29. Presumably this means that one of ordinary skill in the art 11 can immediately envision the uncoated fluoroquinolone in the poloxamer gel. 12 This assertion gives us pause. The fact that any active agent can be used 13 with a particular polymer is true to some extent. But whether this is an 14 anticipatory description of the claimed fluoroquinone suspended in the particularly 15 claimed thermosetting gel for intratympanic injection is less than clear to us. 16 Dr. Berkland has not discussed any of the other delivery options in WO 17 ‘949. We see at least four types of delivery vehicles in WO ‘949 – solid, semi-18 solid, gel-like, or liquid; prepared in suspension, emulsion, or thermosetting gel. 19 Ex. 2006, p. 7. Indeed, fluoroquinolone could be dispensed in hyaluronic acid (p. 20 5) or polymers made from natural polysaccharides, synthetic polymers including 21 polyesters based on polylactide, poluglycolide, polycaprolactone, and their 22 copolymers, block copolymers of polyethylene oxide, and polybutylene 23 terephthalate. Id., 8. 24 Interference 106,030 Motions Decision 10 If gels are selected, one can turn to hyaluronic acid including hyaluronates, 1 lecithin gels, polyalanine derivatives, pluronics, polyethylene glycol, poloxamers, 2 chitosans, xyloglucans, collagens, fibrins, polyesters, polylactides, polyglycolide or 3 their co-polymers PLGA, sucrose acetate isobutyrate, and glycerol monooleate. 4 Id., 9. 5 Other biocompatible polymers are disclosed as well – polypeptides including 6 polyalanine, proteins such as fibrin, starch, cellulose, gelatin, pluronics, tetronics, 7 chondroitin sulfates, and mucopolysaccharides. Id., 12. The medicament can be a 8 core surrounded by a diffusion barrier such as a membrane, capsule, microcapsule, 9 liposome, or hollow fiber. Id. A gel containing microspheres is also disclosed. 10 Id., p. 14. Topical administration is also described in a variety of carriers such as 11 saline, alcohols, vegetable oils, benzyl alcohols, alkylene glycols, polyethylene 12 glycols, glycerol triacetate, gelatin, carbohydrates such as lactose or starch, 13 magnesium, stearate, talc and petrolatum. Id., p. 17. 14 Given all of these possible combinations, and the numerous specific 15 elements required in claim 38, we conclude that, despite the testimony of Dr. 16 Berkland to the contrary, Auris has not met its burden of showing that WO ‘989 17 anticipates the claimed subject matter.2 There is in our view too much picking and 18 choosing among embodiments for one of ordinary skill in the art to envision the 19 claimed invention. We therefore deny Auris Motion 2. Consequently, we need not 20 reach the issue of the cross-applicability of the prior art. 21 22 2 We offer no opinion as to whether the subject matter would have been obvious, which issue has not been raised before us in Aurus Motion 2. Interference 106,030 Motions Decision 11 III. Otonomy Motions 1 and 2 - 35 U.S.C. § 112 1 Otonomy Motion 1 (Paper 53) is a motion for judgment of unpatentability 2 against Auris’s claims 1-9 of US Patent 9,066,865 under 35 U.S.C. § 112 (a) 3 because the written description portion of the specification of the involved patent 4 allegedly lacks full-scope support for a method of using a controlled release 5 composition comprising a pharmaceutically active agent wherein the 6 pharmaceutically active agent is selected from antibiotics and is suspended in the 7 composition.Otonomy Motion 2 (also Paper 53) is also a motion for judgment of 8 unpatentability against Auris’s claims 1-9 of US Patent 9,066,865 under 35 U.S.C. 9 § 112 (a), but because the written description portion of the specification of the 10 involved patent allegedly lacks full-scope support for treating a middle or inner ear 11 disease with fluoroquinolone. 12 Whether the requirement for an adequate written description to support the 13 claimed subject matter has been met is a question of fact and thus depends on the 14 particular facts of the case. Wang Laboratories, Inc. v. Toshiba Corp., 993 F.2d 15 858, 865 (Fed. Cir. 1993). The question to be addressed here is whether the 16 originally filed disclosure would not have reasonably conveyed to one of ordinary 17 skill in the art that Aurus had possession of the subject matter now claimed. In re 18 Edwards, 568 F.2d 1349, 1351-52 (CCPA 1978). Put another way, the written 19 description requirement does not require the applicant to describe exactly the 20 subject matter claimed, rather, the description must clearly allow persons of 21 ordinary skill in the art to recognize that the inventor invented what is claimed. In 22 re Gosteli, 872 F.2d 1008, 1012 (Fed. Cir. 1989) (citing In re Wertheim, 541 F.2d 23 257, 262 (C.C.P.A. 1976)). 24 Interference 106,030 Motions Decision 12 Auris claim 1 is a method claim reciting (bracketed matter added): 1 1. A method of treating a middle or inner ear disease comprising 2 [a] intratympanically administering to [b] a patient in need thereof a 3 [c] controlled release composition comprising a [d] pharmaceutically active 4 agent and [e] a thermosetting polymer; wherein 5 [f] the pharmaceutically active agent is selected from antibiotics and [g] is 6 suspended in the composition, and [h] the thermosetting polymer has a 7 gelation temperature of at least about 15° C, 8 9 wherein [i] the thermosetting polymer is poloxamer 407 and [j] is present at 10 a concentration of about 20% (w/w), and 11 12 wherein [k] the antibiotic is fluoroquinolone. Ex. 2001 17:13-20. 13 14 It is worth observing that Otonomy’s own claims are limited to the treatment 15 of only a viral or bacterial infection of the inner ear. See., e.g. Paper 11, 2, line 7. 16 Auris claim 1 is not, and indeed must be broader by virtue of claims 8 and 9. 17 Otonomy Motion 1 argues that ketamine treatment of the inner ear is the 18 invention of the ‘865 patent, and prior to the filing of a preliminary amendment no 19 Auris application disclosed or claimed a method of administering a composition 20 without an arylcycloalkylamine such as ketamine. Paper 53, 9. 21 It is true that the vast majority of the written description of the ‘865 patent 22 presumes ketamine to be a component of its compositions, and the other 23 pharmaceutical components to “further comprise one or more other 24 pharmacologically active compounds.” Ex. 2001, 11:17–19. We are unable to 25 locate a portion of the written specification, excluding the claims, which teaches a 26 composition without an arylcycloalkylamine. Indeed the inventive “compositions 27 … incorporate an arylcycloalkylamine agent.” Id. 6:11. 28 Interference 106,030 Motions Decision 13 On the other hand, the specification does describe the use of fluoroquinolone 1 as an antibiotic. Id. 11:21–22. The specification also teaches the use of the 2 composition for the treatment of inner ear infection by injection. Id., 12–13. The 3 specification teaches the use of a 20% poloxamer gel which thermosets at 15 4 degrees Celsius. All of the working examples do include ketamine. Id. 7:25–30 5 and 16:28–34. 6 We only find a composition without the mandatory inclusion of an 7 arylcycloalkylamine in the claims added by preliminary amendment filed 8 simultaneously with application 14/317,319, on June 27, 2014. Ex. 2015, 3. 9 Claims 26-33, and 35-44 of the preliminary amendment do not appear to require an 10 arylcycloalkylamine.3 11 Neither party to the interference specifically cites to 37 C.F.R. § 1.115(a)(1) 12 or directly discusses its import. Rule 115 has been in force since 2004 and 13 provides that: 14 (1) A preliminary amendment that is present on the filing date of an 15 application is part of the original disclosure of the application. 16 17 69 FR 56543, Sept. 21, 2004. Moreover, original claims are part of the disclosure. 18 In re Koller, 613 F.2d 819 (CCPA 1980) (original claims can constitute their own 19 description). Of course, the claims must support themselves if no description 20 elsewhere does. 21 New claim 26 did not require arylcycloalkylamine, although it recited a 22 Markush group which included NMDA-receptor antagonists, of which ketamine 23 (an arylcycloalkylamine) is one, in a thermosetting gel composition having a 24 3 Claim 34 recites gacyclidine. Interference 106,030 Motions Decision 14 gelation temperature of 15 degrees Celsius. Paper 53, 2; Ex. 2015, 3. New claim 1 27 recited suspending the pharmaceutical in the composition. New claim 31, by 2 inclusion of intervening dependent claims, requires 20% w/w poloxamer 407 3 thermosetting polymer with the pharmaceutical dispersed therein. New claim 35 4 specifically recited a fluoroquinolone as the pharmaceutically active agent. 5 Otonomy notes that even were the “new” material added by amendment 6 considered, a person of ordinary skill in the art would consider the antibiotic to be 7 part of a combination therapy with arylcycloalkylamine. Paper 53, 10–11. As 8 support for this statement, we are cited to the Declaration of Dr. Salt, Ex. 1039. 9 Dr. Salt admits to owning Otonomy stock and options. Ex. 1039, ¶ 9. We 10 are provided with a statement of their value, $18,000. What would be more useful 11 to us in assessing his interest in the outcome of the proceeding would be an 12 explanation of the circumstances of their acquisition and the financial inputs 13 needed to understand the influence his interest might have - the number of shares 14 and the option strike price, or the terms of the exercise of the option (i.e., put 15 versus call, and conditions for exercise). Given how much relevant information is 16 withheld from us, and the potential volatility and large potential of option 17 valuation, we have some concerns about the financial interests and consequently 18 we find that there is a possibility of bias as regards this witness. We consider Dr. 19 Salt otherwise qualified to testify as an expert on the subject matter of this 20 interference. Ex. 1039, ¶ 1–6; see also Ex. 1023. 21 He testifies that the Auris claims lack written support because the 22 specification of the ‘865 patent recites compositions including 23 arylcycloalkylamine. One of ordinary skill in the art, he reasons, would believe 24 Interference 106,030 Motions Decision 15 that the composition contains an arylcycloalkylamine as an active agent, and would 1 not have understood the abstract to imply the inclusion of fluoroquinolones or any 2 other compound as the sole active agent. Ex. 1039 ¶ 60. Fluoroquinolone, 3 according to Dr. Salt, was not approved for use in treating vertigo, hearing loss, 4 tinnitus or auto-immune disorders. Id. ¶ 58. A person of ordinary skill, therefore, 5 would not have expected fluoroquinolones in general to have efficacy in treating 6 vertigo, hearing loss, tinnitus, or autoimmune disorders. Id. 7 Dr. Salt then testifies as to the specification’s deficiencies in treating any 8 disease with a fluoroquinolone. Id., ¶ 60. Although acknowledging 9 fluoroquinolone is discussed, Dr. Salt testifies that this is in a combination therapy 10 regimen only. Id. ¶ 61. Dr. Salt further observes that this deficiency extends to the 11 figures, which describe compositions containing ketamine. Id. ¶ 63. He continues 12 his analysis in ¶¶ 64–74, before concluding that a person of ordinary skill in the art 13 would not have been able to formulate a composition containing “a 14 pharmaceutically active agent...wherein the pharmaceutically active agent is 15 selected from antibiotics...and wherein the antibiotic is fluoroquinolone” to treat 16 “a middle or inner ear disease” as claimed in claim 1. Id. ¶ 75 (emphasis in 17 original). 18 Dr. Salt reflects an understanding that there was a set of claims filed by 19 preliminary amendment. Id. ¶ 56, citing Ex. 1034. Although he terms it “new 20 matter,” he appears to recognize that the preliminary amendment can be relied 21 upon to support the instant Auris claims. Id. ¶ 81. His position is that the 22 preliminary amendment dependent claims do not mention suspending a 23 fluoroquinolone in a 20% (w/w) poloxamer, and a person of ordinary skill would 24 Interference 106,030 Motions Decision 16 need to pick and choose among the various alternatives in the dependent claims 1 without any guidance and against the teaching of the specification. Id. Such 2 would result in an active agent in a thermosetting polymer or a suspension of a 3 microsphere in a high viscosity gel, in order to achieve a controlled release of the 4 agent in to the inner ear as desired by the specification. Id., ¶ 82. He testifies to 5 the problems associated with formulating a suspension of fluoroquinolone in a gel 6 and that some formulations would result in solutions and not suspensions. Id. ¶¶ 7 83–87. He concludes that a person of ordinary skill in the art would not have 8 considered the combination of a thermosetting gel and a suspension of a 9 fluoroquinolone based on the teachings of the specification. Id. ¶ 88. 10 Otonomy further observes that the description of the ‘319 application 11 regards suspensions and thermosetting gels as alternatives, not to be combined 12 together. Paper 53, 16, citing Ex. 1035 at 0015. 13 Auris in opposition observes that Otonomy provides “no legal authority that 14 prohibits Auris from filing new claims in a continuation that cover different 15 embodiments in their specification, even after a third party attempts to claim such 16 inventions as their own.” Paper 99, 3. But that statement does not capture the true 17 essence of the issue presently facing us. We observe that the only description of 18 the invention as presently claimed is in the claims filed by amendment, and it is in 19 fact somewhat divorced from the entirety of the rest of the description in making 20 the invention, and the only description of this embodiment without inclusion of 21 arylcycloalkylamine (except as a member of the Markush group). 22 Nonetheless, we find that the claims added by the preliminary amendment 23 do describe middle or inner ear treatment with a pharmacological agent and a 24 Interference 106,030 Motions Decision 17 thermosetting polymer. Ex. 2015, 3, claim 26. They also describe suspension and 1 dispersion of a suspension of the pharmacological agent. Id., claims 27 and 28. 2 They further describe 20% w/w of poloxamer 407. Id., claim 31. Finally, they 3 describe an active agent as being fluoroquinolone. The question is thus focused on 4 whether those claims support the instant claims with their additional limitations. 5 Added Claim 26 recites: 6 26. (New) A method of treating a middle or inner ear disease 7 comprising administering to a patient in need thereof a controlled release 8 topical composition comprising a pharmaceutically active agent and a 9 thermosetting polymer; wherein the pharmaceutically active agent is 10 selected from a group consisting of antibiotics, steroids, and NMDA 11 receptor antagonists, and the thermosetting polymer has a gelation 12 temperature of at least about 15 °C. 13 14 Ex. 2015, 3. 15 16 Patent claim 1 in question recites: 17 18 1. A method of treating a middle or inner ear disease comprising 19 intratympanically administering to a patient in need thereof a controlled 20 release composition comprising a pharmaceutically active agent and a 21 thermosetting polymer; wherein the pharmaceutically active agent is 22 selected from antibiotics and is suspended in the composition, and the 23 thermosetting polymer has a gelation temperature of at least about 15 °C, 24 wherein the thermosetting polymer is poloxamer 407 and is present at a 25 concentration of about 20% (w/w), and wherein the antibiotic is 26 fluoroquinolone. 27 Paper 6, 3. 28 29 Claim 26 has the same preamble as the instant claim 1. Claim 26 also has 30 the same method step except for the use of the word “intratympanically.” Claim 31 26 instead says that the composition is “topical.” Intratympanic administration is 32 Interference 106,030 Motions Decision 18 a direct form of administration to the middle ear, and is considered topical as to the 1 inner ear, in that the medicament is not injected into the inner ear but rather into 2 the middle ear from where it diffuses across the round window membrane into the 3 cochlea. See Ex. 2008 ¶ 21. Consequently, there is no meaningful difference 4 between the method steps. 5 The composition of claims 26 and 1 is the same basic composition, a 6 pharmaceutical agent and a thermosetting polymer with a gelation temperature of 7 at least about 15 ̊ C. 8 The differences between the as-filed claim 26 and the presently at issue 9 claim 1 we see are: 10 -claim 26 includes a Markush group of antibiotics, steroids, and 11 NMDA receptor antagonists, while claim 1 now recites a single class – 12 antibiotics, and in that class a single antibiotic – fluoroquinolone. 13 - claim 1 recites that the pharmaceutical is “suspended” in the 14 composition. 15 - claim 1 recites a specific gel, poloxamer 407. 16 - claim 1 recites the poloxamer should be present in an amount of 17 about 20% w/w. 18 Added Claim 27 depends from claim 26 and recites a suspension. Added 19 Claim 31 depending on claim 26 through intermediate claims 29 and 30 recites 20 20% w/w of poloxamer 407. Added claim 35 recites a fluoroquinolone. Ex. 2015, 21 3–4. The non-fluoroquinolone claims were canceled in response to a restriction 22 requirement. Exs. 2016, 2017. 23 Interference 106,030 Motions Decision 19 Issues of the written description requirement of 35 U.S.C. § 112, first 1 paragraph, are questions of fact. Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 2 1563 (Fed. Cir. 1991). 3 The adequate written description requirement serves “to ensure that the 4 inventor had possession, as of the filing date of the application relied on, of the 5 specific subject matter later claimed by him [or her]; how the specification 6 accomplishes this is not material.” In re Wertheim, 541 F.2d 257, 262 (CCPA 7 1976). In order to meet the adequate written description requirement, the applicant 8 does not have to utilize any particular form of disclosure to describe the subject 9 matter claimed, but “the description must clearly allow persons of ordinary skill in 10 the art to recognize that [he or she] invented what is claimed.” In re Gosteli, 872 11 F.2d 1008, 1012 (Fed. Cir. 1989) (citation omitted). Put another way, “the 12 applicant must . . . convey with reasonable clarity to those skilled in the art that, as 13 of the filing date sought, he or she was in possession of the invention.” Vas-Cath, 14 935 F.2d at 1563-64. “Precisely how close the original description must come to 15 comply with the description requirement of [section] 112 must be determined on a 16 case-by-case basis.” Eiselstein v. Frank, 52 F.3d 1035, 1039 (Fed. Cir. 1995) 17 (quoting Vas-Cath, 935 F.2d at 1561). 18 This is a close case on its facts. The embodiment of preliminary amendment 19 claim 31 recites the subject matter of a preferred poloxamer and the concentration, 20 lacking only the elements of a suspension and fluoroquinolone, which are the 21 respective specific subjects of other dependent claims - 27 and 35. 22 The non-claim portion of the specification consistently describes the use of 23 ketamine, including fluoroquinolone only as a potential adjunct pharmaceutical, in 24 Interference 106,030 Motions Decision 20 a variety of formulations. This evidence tends to support Otonomy’s argument. 1 In a contrary view, Auris asserts that there is no statement that an 2 arylcycloalkylamine is critical, essential, or required in the ‘319 application. Paper 3 99, 7. 4 Auris observes that the claims as filed in the preliminary amendment cover 5 “different embodiments in the specification.” Paper 99, 3. Auris contends it was 6 in possession of a broader formulation technology. Id., 8. Dr. Berkland testifies 7 that where the written description of the specification uses the term “other” in 8 conjunction with ketamine it means alternatives, not additional. Ex, 2021, ¶ 29. 9 We are not persuaded by this specific testimony of Dr. Berkland, which testimony 10 is quite contrary to the plain language of the specification as a whole. Other than 11 the expert’s opinion testimony, there is no significant or persuasive evidence in the 12 record to support this analysis or opinion. The only objective factual support for 13 the claim requiring only fluoroquinolone we have been pointed to is the claim set 14 provided by preliminary amendment of June 27, 2014. 15 Dr. Salt, on the other hand, concluded that a person of ordinary skill in the 16 art would not have considered the combination of a thermosetting gel and a 17 suspension of a fluoroquinolone based on the teachings of the specification. Ex. 18 1039 ¶ 88. We are also not persuaded by his testimony. In short, the added claims 19 speak plainly otherwise, overcoming even the specification’s clear focus on 20 inclusion of another medicament. 21 Consequently, we find Otonomy has not met its burden of showing a lack of 22 written description as regards Motion 1. 23 Interference 106,030 Motions Decision 21 Turning to Motion 2, Otonomy urges that Claims 1-9 require the treatment 1 of a middle ear disease, and the specification discusses only treating the inner ear. 2 Paper 53, 11. According to Otonomy, one of ordinary skill in the art could not 3 reconcile the added matter of middle ear disease treatment with the inner ear focus 4 of the specification. Id., 11-12. Moreover, Otonomy urges that fluoroquinolones 5 cannot treat the range of diseases encompassed by Auris’ claims. Id., 13–15. 6 Otonomy provides us with the declaration testimony of Dr. Anthony 7 Mikulec. Ex. 1040. Dr. Mikulec appears qualified to testify to the subject matter 8 of this interference as an expert witness. Ex. 1040, ¶ 1–8, see also Ex. 1029. Dr. 9 Mikulec testifies that the various examples of the Auris ‘319 application are only 10 concerned about diffusion into the inner ear, and not treatment of a middle ear 11 disease. Ex. 1040, ¶¶ 101–103. 12 The heart of the pertinent testimony is found in paragraph 104, which is 13 reproduced below: 14 104. Independent claim 26, filed by preliminary amendment, recites a 15 “method of treating a middle or inner ear disease” by administering an active 16 agent “selected from a group consisting of antibiotics, steroids, and NMDA 17 receptor antagonists” (Ex 1034 at 3, Claim 26). This claim does not mention 18 any specific middle or inner diseases to be treated by the active agent. Also, 19 a person of ordinary skill in the art would have considered treatment of a 20 middle ear disease to be inconsistent with the specification’s consistent 21 identification of the invention as a treatment of inner ear diseases. Although 22 the words “treating a middle ear…disease” appear in the claim, a person of 23 ordinary skill in the art would not be able to reconcile the inconsistency 24 between this terse, generic assertion and the clear, consistent and extensive 25 description of the inner-ear focus in the specification. Such a person would 26 think that Auris did not possess the invention despite its terse, generic 27 statement of a middle-ear alternative in the claim. 28 29 Interference 106,030 Motions Decision 22 Ex. 1040, ¶ 104. 1 Auris points out that Dr. Mikulec testified during cross examination that it is 2 common to prescribe an antibiotic for someone diagnosed as having a middle ear 3 infection. Ex. 2019, pp. 66-68. Additionally, Dr. Berkland testified that 4 fluoroquinolones were known to be used to treat middle ear infections. Ex. 2021, ¶ 5 23. He also testified that treating middle ear infections with fluoroquinolone will 6 inherently treat inner ear infections by diffusing into the cochlea. Id., ¶ 21, 32. 7 Otonomy’s line of reasoning does not persuade us. The claims submitted by 8 preliminary amendment recited a method of treating a “middle or inner ear” 9 disease. Ex. 2015, 3. Despite the above-cited testimony of Dr. Mikulec otherwise, 10 we find one of ordinary skill in the art would understand Auris contemplated 11 diseases of the middle or inner ear, to be treated by an antibiotic, steroid, or 12 NDMA receptor antagonist, by virtue of the claim set filed by preliminary 13 amendment. 14 Otonomy next asserts that fluoroquinolones were not useful for the treatment 15 of the diseases which were the object of the instant specification. Paper 53, 14. 16 Fluoroquinolone appears in a list of ingredients to be used with the 17 arylcycloalkylamine, as an antibiotic. Ex. 2001; 11:21–22. According to 18 Otonomy, Dr. Mikulec explains that the passing mention of fluoroquinolone is not 19 a description of treatment of any disease with fluoroquinolones, beyond possibly 20 bacterial infection. Id., citing Ex. 1040 ¶ 65 (emphasis added). 21 This argument sounds somewhat more in the enablement side of 35 U.S.C. § 22 112. To the extent that it is, we consider whether the Auris claims meet the 23 enablement requirement. The enablement requirement of 35 U.S.C. §112, first 24 Interference 106,030 Motions Decision 23 paragraph, requires that the patent specification enable “those skilled in the art how 1 to make and use the full scope of the claimed invention without ‘undue 2 experimentation’” Genentech, Inc. v. Novo Nordisk. A/S, 108 F.3d at 1365 (quoting 3 In re Wright, 999 F.2d 1557, 1561 (Fed. Cir. 1993)). 4 Otonomy urges that a person having ordinary skill in the art at the time of 5 the invention would have known or been able to determine readily the diseases for 6 which fluoroquinolones were an approved or scientifically accepted treatment – 7 microbial infections. Further, Otonomy asserts that the person having ordinary skill 8 would also have known that fluoroquinolones are not approved for the treatment of 9 tinnitus, hearing loss, auto-immune disorders, vertigo, and Meniere's Disease and 10 might actually cause them as unwanted side effects. Paper 53, 14, citing Ex. 1040 11 ¶55–57; Ex. 1024 at 559, 564, 575, 2384, 2082, and 1049; and Ex 1025 at 308, 12 606, 1365. 13 At the outset, we find that the Auris claims are enabled for the treatment of 14 inner and middle ear diseases caused by microbiological infections utilizing 15 fluoroquinolone in the thermosetting gel. The evidence of record establishes that it 16 was common knowledge to use a fluoroquinolone topically in the ear regions. 17 Ex. 1040 ¶¶ 55–57, Ex. 1024. Auris claim 9 recites the middle ear disease is a 18 viral or bacterial infection. Paper 6, 4. Fluoroquinolone is stated to be an 19 antibiotic in Auris’ specification. As a consequence, the motion fails as regards to 20 claim 9. 21 The more difficult question we face is that of what diseases claim 1 22 encompasses, and whether those claims are enabled for the treatment of those other 23 Interference 106,030 Motions Decision 24 diseases utilizing fluoroquinolone. Claim 8 recites the “group consisting of 1 tinnitus, hearing loss, inner ear inflammations or infections, auto-immune 2 disorders, vertigo, and Meniere’s Disease.” Id. As claim 8 depends from claim 1, 3 claim 1 must have at least this scope. Claim 2–7 each depend, directly or 4 indirectly, from claim 1, thus each must also have at least this scope in terms of 5 diseases that may be treated with the pharmaceutically active ingredient 6 fluoroquinolone. 7 It is useful at this juncture to observe how the claims ended up in this 8 arrangement. Claim 26, as filed recited a Markush group of medicament 9 categories, a “group consisting of antibiotics, steroids, and NMDA receptor 10 antagonists.” Examiner Love required restriction to: 11 a single specific species of active agent (such as a single species from 12 dexamethasone, gacyclidine, or fluoroquinolone), a single specific species of 13 thermoplastic polymer (such as poloxamer 407), a single method of delivery 14 (such as a single species from infusion, injection), a single species of either 15 middle or inner ear, and a single disease (such as a single species from 16 Meniere's Disease, hearing loss, cochlear tinnitus, reduced perception of 17 tinnitus or sound, excitotoxicity-induced ear cell degeneration, or age-18 induced ear cell degeneration. 19 20 Ex. 2016, 2. 21 In response to the restriction requirement, the Applicant deleted the Markush 22 group elements of steroids and NDMA inhibitors, and canceled claims 33, 34, 42, 23 43, and 44 – which recited the compounds dexamethasone and gacyclidine, the 24 diseases cochlear tinnitus, excitotoxicity-induced ear cell degeneration or age-25 induced ear cell degeneration, and the treatment for reducing the perception of 26 tinnitus or sound. Ex. 1017, 5–7. However, the Applicant did not delete claim 41, 27 Interference 106,030 Motions Decision 25 which ultimately became claim 8, which recites diseases including tinnitus, hearing 1 loss, inner ear inflammations or infections, auto-immune disorders, vertigo, and 2 Meniere's Disease. Id., 6. Nor was claim 1 amended to narrow the scope of 3 diseases treated. This is consistent with Auris’ current position that treatment of 4 such diseases is enabled. 5 The Specification “background” indicates that lidocaine, gabapentin, 6 nortryptline, melatonin, caroverine, baclofen, alprazolam, gacyclidine, 7-7 chlorokynurenate and ketamine have been tested for tinnitus. Ex. 1035, 1. 8 Methylprednisolone is said to be known for the treatment of sudden deafness or 9 tinnitus following noise trauma. Id., 3. A description of gentamycin in hyaluronic 10 acid is discussed for that use as well. Id., 4. NDMA antagonists gacyclidine, D-11 AP5, MK 801 and 7-chlorokynurenate are said to be used “for the treatment of 12 various inner ear diseases.” Id. 13 Turning to the description of the invention, the Specification observes that 14 arylcycloalkylamine may “suppress or reduce the perception of tinnitus.” Id. Such 15 treatment may be for inner ear disorders. Id., 5. Fluoroquinolones are identified as 16 antibiotics; cortisone as a steroid; antipyrine, benzocaine, and procaine as 17 analgesics; methionine, N-acetylcysteine, and trolox as antioxidants; GDNF and 18 BDNF as neurotrophins; and leupetrin and caspace inhibitors as anti-apoptotic or 19 anti-necrotic agents. Id., 17. The compositions generally are said to be used for 20 treating inner ear diseases such as tinnitus, hearing loss, inner ear inflammation or 21 infection, autoimmune ear disorder, vertigo, Meniere’s disease, inner ear cell 22 degeneration or age-induced inner ear cell degeneration. Id., 18. But which 23 medicaments are for which disease are not specified. 24 Interference 106,030 Motions Decision 26 Otonomy puts forth the testimony of Dr. Mikulec that when the ’319 1 application was filed, a person having ordinary skill in the art would have known 2 or been able to determine readily the diseases for which fluoroquinolones 3 were an approved or scientifically accepted treatment. Paper 53, 14 citing Ex 1040 4 ¶55. 5 According to Otonomy and Dr. Mikulec, such a person would have 6 understood that fluoroquinolones would be used for treating microbial infections, 7 and are not approved for other uses (at least tinnitus, hearing loss, auto-immune 8 disorders, vertigo, and Meniere's disease) and would not have administered them 9 for the listed diseases. Ex 1040 ¶¶ 55–56, citing Ex. 1024 and 1025. 10 Auris counters on several grounds. First, that Otonomy has not met the 11 standards for granting relief – a demonstration that the claimed invention may not 12 be practiced without undue experimentation. Paper 99, 4. According to Auris, 13 neither of Otonomy’s experts was familiar with the appropriate standards for 14 conducting their analysis, and each had undisclosed interests in the outcome of the 15 proceeding. Id., 3–7. Dr. Mikulec in particular is asserted to not have been 16 informed on how to construe claims or what standards to apply. Id. 3-4. We have 17 considered these issues, and have given reduced weight to the experts’ opinions. 18 Auris next argues that the ‘319 application created the novel delivery 19 technology – and it is not restricted to the type of compound to be delivered. Paper 20 99, 9. 21 Auris states that “the ‘319 application states that the compositions of the 22 invention can be used for ‘treatment of tinnitus, hearing loss, inner ear 23 inflammation or infection, autoimmune ear disorder, vertigo, Meniere’s Disease, 24 Interference 106,030 Motions Decision 27 inner ear cell degeneration or age-induced inner ear cell degeneration.’ Ex. 2005, 1 p. 18, ¶ 4. Such proposed uses do not convey a focus on a single class of agents. 2 Ex. 2021, ¶ 27.” Paper 99, 10. 3 The parties’ positions are not inconsistent– the specification does focus on 4 the use of ketamine as a treatment, but it does allow for the inclusion of other 5 medicaments into the formulation, including fluoroquinolone. 6 Auris further contends that antibiotics are commonly used to treat the 7 disorders listed in dependent claims 8 and 9. Id., 18-19. Auris also correctly 8 observes that approved uses do not account for off-label known uses. Paper 99, 20, 9 citing Ex. 2029, 5. Interestingly, the most relied upon evidence is Otonomy’s 10 involved application, Ex. 1001, mostly as a form of an admission by Otonomy. 11 Paragraphs 152–174 of Otonomy’s involved application discuss the possible side 12 effects of microbial infections including syphilis (tinnitus, deafness, vertigo, 13 malaise, sore throat, headaches, skin rashes, sudden hearing loss) (¶ 152), viral 14 infection (AIED (¶ 159), Menier’s Disease (¶ 162), vestibular neuronitis (¶ 168), or 15 sensorineural hearing loss (¶ 173)). 16 Because of this disclosure, Auris considers Otonomy’s arguments that one of 17 ordinary skill in the art would not use fluoroquinolone to treat these disorders as 18 disingenuous. Paper 99, 19. 19 The one objective publication relied upon for this position is Ex. 2024, cited 20 by Auris as “see also,” which is, so far as we can tell, an article discussing hearing 21 impairment as a result of otitis media with perforated tympanic membrane and 22 suppuration resulting in destruction of the ossicular chain resulting in deafness. 23 Ex. 2024, p. 2, second full paragraph. We think this tends to support the position 24 Interference 106,030 Motions Decision 28 that an infection can cause hearing loss; but does not offer much support to the 1 reverse position, that treating with fluoroquinolone will cure hearing loss. 2 Auris next urges that Dr. Mikulec misconstrued the claims as requiring 3 fluoroquinolone as the sole active therapeutic. Paper 99, 19–20. Instead, Auris 4 asserts that the claims cover delivery of “controlled release composition that 5 include fluoroquinolone both as a monotherapy and as a combination therapy.” 6 Auris’ argument overlooks the requirement of the claim that the 7 fluoroquinolone is a therapeutic agent for the middle or inner ear disease, 8 regardless of whether any other agent is present. More specifically, claim 1 recites 9 a “method of treating a middle or inner ear disease comprising intratympanically 10 administering …a controlled release composition comprising a pharmaceutically 11 active agent and a thermosetting polymer; wherein the pharmaceutically active 12 agent is selected from antibiotics . . . wherein the antibiotic is fluoroquinolone.” 13 Paper 6, 3. In short, claims 1-9 require that the fluoroquinolone must be a 14 pharmaceutically active antibiotic agent which treats the disease. And the 15 “disease” must, by definition, be broader than only an infection. Cf. claim 8. Only 16 claim 9 restricts the disease being treated to an infection, which is a known use of 17 an antibiotic. 18 By virtue of use of the term comprising, Auris is also correct that the claim 19 is not closed to additional agents, which means that the fluoroquinolone may be 20 used in a combination therapy. However, we conclude that the claim’s basic 21 requirement is that fluoroquinolone must treat the disease, even in the absence of 22 other unexcluded ingredients. 23 Interference 106,030 Motions Decision 29 Otonomy’s ultimate position is that the description of fluoroquinolone as an 1 antibiotic does not provide sufficient information for a person having ordinary skill 2 in the art to make and use a composition in which a fluoroquinolone is the 3 pharmaceutically active ingredient to treat any inner or middle ear diseases other 4 than bacterial infections. Paper 53, 14, citing Ex. 1040 ¶ 65. 5 In opposition to this point, Auris asserts that the disclosure is not restricted 6 to the inclusion of arylcycloalkylamines. Paper 99, 10. We agree that the 7 preliminary claims (which were part of the original disclosure) are not so limited. 8 The remainder of the description appears to contemplate an arylcycloalkylamine 9 being present, despite Auris’ attempt to read the specification otherwise. Auris 10 also asserts that fluoroquinolones are described as an active ingredient. Id. We 11 agree, but that description is only in their role as an antibiotic, and then as part of a 12 combination therapy. Ex. 2005, 17. Again, only the claims indicate 13 fluoroquinolone monotherapy was contemplated. 14 Auris next asserts that intratympanic administration of fluoroquinolone to 15 treat an infection of the middle ear was envisioned. Paper 99, 13. We agree, but 16 principally because the claims submitted by preliminary amendment clearly state 17 those limitations. We accept the testimony of Dr. Berkland that one of ordinary 18 skill in the art would recognize that treatment of the middle ear with an antibiotic 19 would treat a middle ear infection. Ex. 2021, ¶ 32. 20 Auris next assertion goes somewhat farther – that one of ordinary skill in the 21 art would know, because the disorders listed in dependent claim 8 “are directly 22 associated with an infection of the middle ear” that those disorders are treatable by 23 the claimed method. Paper 99, 13-14. As support for this assertion we are again 24 Interference 106,030 Motions Decision 30 pointed towards the testimony of Dr. Berkland, who states that “the conditions 1 recited in claim 8 are known to involve microbial infections.” Ex. 2021, ¶ 41. He 2 also states it is “reasonable to expect” fluoroquinolones would have use in the 3 claimed method. Infection, he states “is often accompanied by” hearing loss, 4 vertigo, and tinnitus. Autoimmunity “can be” a side effect of antimicrobial 5 immune response. Meniere’s disease “ha[s] been associated” with infection. Id. 6 While we have no doubt this testimony is the literal truth, the real issue is 7 somewhat disguised by presenting the issue as if the cause of the disease is known. 8 Microbial infections are not the only known cause of Meniere’s disease, or 9 tinnitus, or autoimmune diseases. 10 While Auris is correct that Otonomy has not established the absolute amount 11 of experimentation necessary; in the absence of any guidance in the specification 12 on how to utilize fluoroquinolone in the treatment of other inner ear diseases, we 13 find that this infirmity does not outweigh the other factors. Dr. Salt testified that a 14 person of ordinary skill in the art in 2014 would have had to perform extensive 15 experimentation to determine the efficacy of fluoroquinolone against vertigo, 16 hearing loss, tinnitus or autoimmune disorders such as Meniere’s Disease with no 17 guidance. Ex. 1039, ¶ 58-60. We find that testimony to be credible and in line 18 with the objective evidence of the Auris specification; and the paucity of its 19 disclosure as regards fluoroquinolones specifically. 20 Otonomy’s position, therefore, has merit. For one to enable an invention, 21 one must describe it sufficiently such that one can make and use the invention 22 without undue experimentation. In re Wands, 858 F. 2d 731 (Fed. Cir. 1988). 23 Among the so-called Wands factors: 24 Interference 106,030 Motions Decision 31 (1) the quantity of experimentation necessary, (2) the amount of guidance 1 presented, (3) the presence or absence of working examples, (4) the nature of the 2 invention, (5) the state of the prior art, (6) the relative skill of those in the art, (7) 3 the predictability or unpredictability of the art, and (8) the breadth of the claims. 4 858 F. 2d at 737. 5 There are no examples utilizing fluoroquinolone, and no description beyond 6 the generic antibiotic use of fluoroquinolones. There is no guidance presented on 7 using fluoroquinolone for treatment of inner ear diseases beyond identifying it as 8 an antibiotic in the specification and claims. The claims are unquestionably broad, 9 covering the treatment of any disease of the inner ear with fluoroquinolone in the 10 thermosetting gel. The treatment of human disease, especially when the complete 11 etiology of the disease is unknown, such as is the case in the claimed Menier’s 12 disease, can certainly be unpredictable. 13 As a consequence, we find that a preponderance of the evidence supports 14 Otonomy Motion 2 as regards the enablement of claims 1-8 for the treatment of 15 any disease of the middle or inner ear utilizing fluoroquinolone. 16 Otonomy Motion 2 is therefore granted in part, and we conclude that 17 claims 1-8 are unpatentable. 18 IV. Auris Motion 1 – Priority Benefit 19 Auris Motion 1 is a motion for benefit of U.S. Application 11/992,632, filed 20 26 March 2008 and International Application PCT/EP2005/010478, filed 28 21 September 2005. 22 Interference 106,030 Motions Decision 32 A. Standard 1 To establish a constructive reduction to practice and thereby the right to 2 benefit of an earlier-filed patent application for the purposes of priority, the 3 moving party need only show that the earlier filed application discloses a single 4 enabled embodiment within the scope of the interference count. Hunt v. 5 Treppschuh, 523 F.2d 1386, 1389 (C.C.P.A. 1975). 6 B. The Count 7 1. A method of treating a middle or inner ear disease comprising 8 intratympanically administering to a patient in need thereof a controlled 9 release composition comprising a pharmaceutically active agent and a 10 thermosetting polymer; wherein the pharmaceutically active agent is 11 selected from antibiotics and is suspended in the composition, and the 12 thermosetting polymer has a gelation temperature of at least about 15° C, 13 14 wherein the thermosetting polymer is poloxamer 407 and is present at a 15 concentration of about 20% (w/w), and 16 17 wherein the antibiotic is fluoroquinolone. 18 The count is claim 1 of Patent 9,066,865. Paper 1, 4. 19 Junior Party Auris desires the count to be interpreted as including 20 fluoroquinolone both as a monotherapy and as a combination therapy. Paper 95, 5. 21 While this is an acceptable interpretation, it omits any discussion of the count’s 22 requirement that the pharmaceutically active ingredient fluoroquinolone must be an 23 active ingredient for the treatment of the disease. Other components may be 24 included, by use of the word “comprising” in the claim language, but 25 fluoroquinolone treatment must be sufficiently described in the pointed to 26 embodiment. 27 Interference 106,030 Motions Decision 33 C. The Evidence in Support of the Motion 1 According to Auris, the ‘478 PCT (Ex. 2006) and the ‘632 application (Ex. 2 2007) are identical to the specification of the ‘319 application. Paper 95, 1. 3 Auris points to page 17 of the ‘478 specification as support for the 4 description of therapy describing a fluoroquinolone in combination with an 5 arylcycloalkylamine. Paper 95, 6. 6 In support of this interpretation, they rely on the testimony of Dr. Berkland. 7 He testifies that: 8 based on the reference to fluoroquinolone as a further active agent in the 9 third paragraph of page 17, the ’478 PCT application makes it clear that the 10 inventor had in his possession a method of treatment whereby an 11 arylcycloalkylamine and fluoroquinolone could be used as a combined 12 therapy for the inner ear. Moreover the precise description of a formulation 13 employing about 20% poloxamer (Lutrol F-127) in Example 2, accompanied 14 by disclosure of controlled release, suspension-based formulations for the 15 treatment of infections and intratympanic injection as a form of 16 administration clearly show that the inventor was in possession of the 17 delivery method. Exhibit 2006, p. 4, para. 1; p. 10, para. 4; p. 12, para. 5; p. 18 15, para. 2; p. 18, para. 4-5; p. 19, 18 para. 2.; pp. 21-26. 19 20 Ex. 2008, ¶ 24. 21 We find that the ‘478 PCT application reveals that the application does 22 describe the addition of fluoroquinolone for use as an antibiotic in the delivery 23 composition for treating inner ear diseases. Ex. 2006, 17. Dr. Berkland’s 24 testimony is credible on this point. Moreover, at least one specific example 25 (Example 2) includes 20% poloxamer 407 and ketamine: 26 Interference 106,030 Motions Decision 34 Methods and materials 1 2 A total of 16 pigmented guinea pigs were administered 100 microlitres of 3 either a hyaluronic acid (Hylumed Sterile, Genzyme Corp.) or a poloxamer 4 (Lutrol F127, BASF) gel formulation containing S-(+)-Ketamine 5 hydrochloride (Cristalia) through a 1ml syringe connected to a needle. Half 6 of the animals received 0.5% hyaluronic acid gel prepared in a phosphate 7 buffered solution at pH 7.4 prepared in accordance with the European 8 Pharmacopeia (ref. 4005000). The Ketamine was dissolved in the gel at a 9 concentration of 1 mM with a magnetic stirrer over night at 4 degrees 10 Celcius. The remaining half of the animals received a 20% poloxamer gel 11 also through a 1ml syringe connected to a needle. The gel was prepared by 12 adding slowly 600 mg of Lutrol powder to 3 ml of the same phosphate 13 buffered solution in a magnetic stirrer (500 rpm). The mixing process 14 continued then for 16 hours to obtain a clear solution with minimum 15 viscosity. As for the hyaluronic acid gel, the Ketamine was dissolved in the 16 poloxamer solution at a concentration of 1 mM with a magnetic stirrer over 17 night. Immediately after contact with the middle ear tissue of the guinea 18 pigs, the poloxamer gelified and became almost solid. 19 20 Ex. 2031, 46; Ex. 2006, 25.4 21 In combination with the description of an additional antibiotic, i.e. 22 fluoroquinolone (Ex. 2031, 38; Ex. 2006, 17), we find that this embodiment meets 23 the limitations of the count. 24 Otonomy initially urges that PCT ‘478 was not produced and cannot be 25 relied upon, and no argument was directed to the ‘632 application. Accordingly, 26 Otonomy urges that we deny the relief requested for a failure of proof. Paper 116, 27 1–2. However, Otonomy points to no discrepancies between the documents as 28 4 The passages in each exhibit appear to be identical, down to the misspelling of “Celsius.” Interference 106,030 Motions Decision 35 materially effecting the underlying substantive issues. Accordingly, we decline the 1 invitation to dismiss the motion on this ground. 2 Otonomy next urges that PCT ‘478 does not teach a middle ear disorder 3 treatment. Paper 116, 3. Whether PCT ‘478 teaches an inner ear disorder 4 treatment is immaterial to this motion, as PCT ‘478 teaches treating the inner ear, 5 which also falls within the scope of the count. Ex. 2031, 22 - Title. 6 Otonomy urges that PCT ‘478 does not teach a suspension of 7 fluoroquinolone in the polymer. Paper 116, 4–6. Rather, Otonomy urges it teaches 8 a suspension as an alternative to the thermosetting gel polymer, or a dispersion. 9 Id., 5. 10 While this argument is literally correct in the passages it cites, it ignores the 11 evidence in the record that ketamine in Example 2 was dissolved in the poloxamer 12 solution with minimum viscosity at a concentration of 1mM and stirred overnight. 13 Ex. 2006, 25. Given that the dissolved ketamine was stirred overnight, we are not 14 certain how it can be persuasively argued that at least the ketamine was not at least 15 suspended in the stirred mixture. 16 In light of the description of fluoroquinolone as an antibiotic ingredient 17 (regardless of its literal designation as an “ingredient” or “active agent”), in the 18 absence of persuasive evidence to the contrary we are of the view that if both were 19 included they would be “suspended” in that embodiment if mixed in the described 20 manner of Example 2. We also are not persuaded by the argument that a 21 dispersion and a suspension are generic and specific in relation. Paper 116, 5. It 22 appears to us that ingredients in a liquid can be both suspended and dispersed 23 simultaneously. Ex. 1014, 409. 24 Interference 106,030 Motions Decision 36 Otonomy next argues that obviousness is insufficient. Paper 116, 6. 1 Otonomy points to Dr. Berkland’s testimony and states that it is more appropriate 2 for an obviousness standard. This statement ignores that there is an example of 3 ketamine suspended in poloxamer injected into the middle ear and diffused into the 4 inner ear, and a clear teaching of an additional embodiment with an additional 5 ingredient, including fluoroquinolones, known antibiotics. Ex. 2031, 26, 38, and 6 46. 7 Accordingly, we GRANT Auris Motion 1. 8 V. Otonomy Motion 6 – Priority Benefit 9 Otonomy Motion 6 is a motion for benefit of application 13/645,126, filed 4 10 October 2012; application 12/506,127, filed 20 July 2009; application 12/466,310, 11 filed 14 May 2009; provisional application 61/140,033, filed 22 December 2008; 12 provisional application 61/101,112, filed 29 September 2008; provisional 13 application 61/094,384, filed 4 September 2008; and provisional application 14 61/083,871, filed 25 July 2008. 15 A. The Evidence in Support of the Motion 16 The earliest priority sought is that of the ‘871 application, filed July 25, 17 2008. Ex. 1011. Otonomy identifies the following areas as support for an 18 embodiment within the count: 19 20 Support for “treating a middle or inner ear disease:” 21 22 Otitis media (OM) is an inflammation of the middle ear. Bacterial infection 23 accounts for a large percentage of OM cases, with more than 40% of cases 24 attributed to Streptococcus pneumoniae infection. However, viruses, as well 25 as other microbes, may account for OM conditions. Because OM can be 26 Interference 106,030 Motions Decision 37 caused by a virus, bacteria or both, various antimicrobial agents are used to 1 eliminate the underlying pathogen. 2 3 Ex 1011, ¶0013. 4 5 Support for “intratympanically administering to a patient in need thereof:” 6 7 In still other embodiments, application of the antimicrobial agent 8 formulation is targeted to the auris media through piercing of the 9 intratympanic membrane and applying the antimicrobial agent formulation 10 directly to the auris media structures affected, including the walls of the 11 tympanic cavity or auditory ossicles. 12 13 Ex 1011, ¶00112. 14 15 Support for “a controlled release composition:” 16 17 In further or alternative embodiments, the auris controlled-release 18 formulations are capable of being administered on or near the round window 19 membrane via intratympanic injection. 20 21 Ex 1011, ¶0017. 22 23 Support for “a pharmaceutically active agent … wherein the 24 pharmaceutically active agent is selected from antibiotics … wherein the antibiotic 25 is fluoroquinolone:” 26 Antibacterial agents include … ciprofloxacin , enoxacin, gatifloxacin, 27 levofloxacin, lomefloxacin, moxifloxacin, norfloxacin, ofloxacin, 28 trovfloxacin . . . . 29 30 Ex 1011, ¶00117 31 32 Typical antibacterial agents for the treatment of OE include ….…. 33 fluoroquinolone (e.g., ofloxacin and ciprofloxacin)….. 34 35 Interference 106,030 Motions Decision 38 Ex. 1011, ¶00069. 1 2 Support for “a thermosetting polymer … wherein the thermosetting polymer 3 is poloxamer 407 and is present at a concentration of about 20% (w/w):” 4 5 [00156] Poloxamer 407 (PF-127) is a nonionic surfactant composed of 6 polyoxyethylene-polyoxypropylene copolymers. … Aqueous solutions of 7 poloxamers are stable in the presence of acids, alkalis, and metal ions. PF-8 127 is a commercially available polyoxyethylene-polyoxypropylene triblock 9 copolymer of general formula E106 P70 E106, with an average molar mass 10 of 13,000. It contains approximately 70% ethylene oxide, which accounts for 11 its hydrophilicity. It is one of the series of poloxamer ABA block 12 copolymers, whose members share the chemical formula shown below. 13 14 15 [00157] PF-127 is of particular interest since concentrated solutions (>20% 16 w/w) of the copolymer are transformed from low viscosity transparent 17 solutions to solid gels on heating to body temperature. This phenomenon, 18 therefore, suggests that when placed in contact with the body, the gel 19 preparation will form a semi-solid structure and a sustained release depot. 20 Furthermore, PF-127 has good solubilizing capacity, low toxicity and is, 21 therefore, considered a good medium for drug delivery systems. 22 23 Ex 1011, ¶¶00156-57. 24 25 Interference 106,030 Motions Decision 39 Support for element “the thermosetting polymer has a gelation temperature 1 of at least about 15° C:” 2 In certain embodiments, the enhanced viscosity formulation is characterized 3 by a phase transition between room temperature and body temperature. In 4 some embodiments, the phase transition occurs at 1 ºC below body 5 temperature, at 2 ºC below body temperature, at 3 ºC below body 6 temperature, at 4 ºC below body temperature, at 6 ºC below body 7 temperature, at 8 ºC below body temperature, or at 10 ºC below body 8 temperature. 9 10 Ex 1011, ¶00154. 11 12 According to Otonomy, a person of ordinary skill would have recognized 13 these Tgels as ranging from 27 ºC to 36 ºC. Paper 54, 14 citing testimony of Dr. 14 Salt that each of these gelation temperatures exceeds 15 ºC. Ex. 1039 ¶36. 15 Support for “the pharmaceutically active agent … is suspended in the 16 composition:” 17 Cosolvents can be used to enhance antimicrobial agent solubility. However, 18 some antimicrobial agents or other pharmaceutical compounds are insoluble. 19 These can often be suspended in the polymer vehicle with the aid of suitable 20 suspending or viscosity enhancing agents. 21 22 Ex 1011, ¶00193. 23 24 Otonomy points out that ciprofloxacin is an example of a fluoroquinolone 25 that is poorly soluble at physiological pH. Ex 1039 ¶87. According to Dr. Salt’s 26 testimony, when the ‘871 provisional was filed, a person of ordinary skill in the art 27 would have understood that the provisional application disclosed how to make a 28 composition for treating at least a middle ear infection by intratympanically 29 Interference 106,030 Motions Decision 40 administering a suspension of a fluoroquinolone antibiotic, specifically 1 ciprofloxacin, in controlled-release composition including about 20% 2 (w/w) poloxamer 407 and having a gelation temperature above 15 ºC. Ex 1039 3 ¶36. Otonomy urges that a person of ordinary skill in the art also would have 4 understood how to use the embodiment. Ex 1040 ¶37. Dr. Salt concludes that this 5 disclosure anticipated the count. Ex 1039 ¶36. Paper 54, 14–16. 6 In opposition, Auris asserts again that Drs. Salt and Mikulec failed to 7 properly address the standard for according benefit, or address the written 8 description and enablement tests. Paper 100, 1–2. According to Auris, the 9 declarations should be excluded. Auris also asserts that Otonomy failed to address 10 written description or enablement separately or sufficiently and the motion should 11 be denied. Id., 2–5. 12 Initially, we observe that Exhibit 1011 is far more general than Otonomy 13 states. It is directed to multiple compositions and methods for the treatment of otic 14 disorders with antimicrobial agents. Ex. 1011, ¶ 0069. 15 They include, to borrow some claim language, as a controlled release 16 excipient: polymers, viscosity enhancing agents, gels, paints, foams, microspheres, 17 microparticles, xerogels, in-situ forming spongy materials, hydrogels, liposomes, 18 nanocapsules, nanospheres, thermoreversible gels, and combinations thereof. Id., 19 ¶¶ 0066, and 00137 and 00138. There are literally hundreds of potential delivery 20 systems discussed in the specification, along with several examples, of which 21 Poloxamer 406 is only one, albeit a preferred one “of particular interest.” Id. 22 Of delivery methods, several are described, including administration on or 23 near the round window membrane via intratympanic injection; administration on or 24 Interference 106,030 Motions Decision 41 near the round window or the crista fenestrae cochleae through entry via a post-1 auricular incision and surgical manipulation into or near the round window or the 2 crista fenestrae cochleae area; application via syringe and needle wherein the 3 needle is inserted through the tympanic membrane and guided to the area of the 4 round window or crista fenestrae cochleae; application via microcatheters 5 implanted into the patient; administration via a pump device onto or near the round 6 window membrane; application at or near the round window membrane via a 7 microinjection device; delivery to the external ear by injection, cotton swab, or as 8 ear drops. Ex. 1011, ¶ 00139. 9 In terms of selection of an antimicrobial agent, it is quite clear that any one 10 is potentially included. For example, the specification includes a discussion that: 11 Any antimicrobial agent useful for the treatment of otic disorders, e.g., 12 inflammatory diseases of the ear or cancer of the ear, is suitable for use in 13 the formulations and methods disclosed herein. In some embodiments, 14 the antimicrobial agent is an antibacterial agent, an antifungal agent, an 15 antiviral agent, an antiprotozoal agent, and/or an antiparasitic agent. 16 Antimicrobial agents include agents that act to inhibit or eradicate microbes, 17 including bacteria, fungi, viruses, protozoa, and/or parasites. Specific 18 antimicrobial agents may be used to combat specific microbes. Accordingly, 19 a skilled practitioner would know which antimicrobial agent would be 20 relevant or useful depending on the microbe identified, or the symptoms 21 displayed. 22 23 Ex. 1011, ¶ 00115. 24 Of the antibacterial agents, a selection can be made from a nonexclusive list 25 including: 26 Antibacterial agents include amikacin, gentamicin, kanamycin, neomycin, 27 netilmicin, streptomycin, tobramycin, paromomycin., geldanmycin, 28 herbimycin, loracarbef, ertapenem, doripenem, imipenem, cilastatin, 29 Interference 106,030 Motions Decision 42 meropenem, cefadroxil, cefazolin, cefalotin, cefalexin, cefaclor, 1 cefamandole, cefoxitin, defprozil, cefuroxime, cefixime, cefdinir, cefditoren, 2 cefoperazone, cefotaxime, cefpodoxime, ceftazidime, ceftibuten, 3 ceftizoxime, ceftriaxone, cefepime, ceftobiprole, teicoplanin, vancomycin, 4 azithromycin, clarithromycin, dirithromycin, erythromycin, roxithromycin, 5 troleandomycin, telithromycin, spectinomycin, aztreonam, amoxicillin, 6 ampicillin, azlocillin, carbenicillin, cloxacillin, dicloxacillin, flucloxacillin, 7 mezlocillin, meticillin, nafcillin, oxacillin, penicillin, piperacillin, ticarcillan, 8 bacitracin, colistin, polymyxin B, ciprofloxacin, enoxacin, gatilloxacin, 9 levofloxacin, lomefloxacin, moxifloxacin, norfloxacin, ofloxacin, 10 trovtloxacin, mafenide, prontosil, sulfacetamide, sulfamethizole, 11 sulfanimilimde, sulfsalazine, sulfsioxazole, trimethoprim, demeclocycline, 12 doxycycline, minocycline, oxtetracycline, tetracycline, arsphenamine, 13 chloramphenicol, clindamycin, lincomycin, ethambutol, fosfomycin, fusidic 14 acid, furazolidone, isoniazid, linezolid, metronidazole, mupirocin, 15 nitrofurantoin, platensimycin, pyrazinamide, quinuspristin/dalfopristin, 16 rifampin, tinidazole, and combinations thereof. 17 18 Ex. 1011, ¶ 00117. To be sure, there are some fluoroquinolones in this list 19 (some bolded). But the choices to be made here, and not discussed by the expert 20 witnesses, are enormous. 21 Otonomy concludes “[that] a person of ordinary skill in the art would have 22 understood that the provisional application disclosed how to make a composition 23 for treating at least a middle ear infection by intratympanically administering a 24 suspension of a fluoroquinolone antibiotic, specifically ciprofloxacin, in 25 controlled-release composition including about 20% (w/w) poloxamer 407 and 26 having a gelation temperature above 15 ºC.” Paper 54, 15, citing Ex 1039 ¶36. 27 Dr. Salt testifies that the ‘871 application therefore “described embodiments 28 within the count.” Ex 1039 ¶36. We disagree with that rather broad conclusion. 29 The ‘871 application describes numerous medicaments, delivery systems, and 30 Interference 106,030 Motions Decision 43 potential methods for applying to various areas of the ear for treatment of various 1 diseases. We cannot discern, however, a specific description of an embodiment 2 which meets all of the elements of the count. While the motion has picked a 3 particular type of medicine to be used in a particular way suspended in a particular 4 carrier, we do not see adequate teaching of those individual elements, combined as 5 in the count. The motion, as a consequence, fails to carry its burden as regards 6 this application. 7 We turn next to the other three provisional applications. Otonomy states that 8 the ‘384 (Ex. 1021), ‘112 (Ex. 1019), and ‘033 application (Ex.1017) each have 9 substantially the same relevant disclosure. Paper 54, 1 and 16. Based upon this 10 representation, the motion fails as to these applications as well. 11 Otonomy also seeks priority benefit of the nonprovisional applications – 12 13/645,126 (Ex. 1006) and 12/506,127 (Ex. 1009). They are said to be 13 substantially identical to each other and the involved application 13/848,636 (Ex. 14 1001). Paper 54, 1, 6. As the earliest filed application is the ‘127 application, we 15 look to it. Ex. 1009. 16 Otonomy points to the description found at paragraph 49, which we 17 reproduce below: 18 Also provided herein is a method of alleviating infection or inflammation 19 associated with an otic intervention comprising administering to an 20 individual in need thereof an intratympanic composition or device 21 comprising a therapeutically effective amount of an antimicrobial agent, the 22 composition or device comprising substantially low degradation products of 23 the antimicrobial agent, the composition or device further comprising two or 24 more characteristics selected from: 25 (i) between about 0.1% to about 10% by weight of the antimicrobial 26 agent, or pharmaceutically acceptable prodrug or salt thereof; 27 Interference 106,030 Motions Decision 44 (ii) between about 14% to about 21% by weight of a polyoxyethylene 1 polyoxypropylene triblock copolymer of general formula E106 P70 E106; 2 (iii) sterile water, q.s., buffered to provide a pH between about 5.5 and 3 about 8.0; 4 (iv) multiparticulate antimicrobial agent; 5 (v) a gelation temperature between about 19 °C to about 42 °C; 6 (vi) less than about 50 colony forming units (cfu) of microbiological 7 agents per gram of formulation; 8 (vii) less than about 5 endotoxin units (EU) per kg of body weight of a 9 subject; 10 (viii) a mean dissolution time of about 30 hours; and 11 (ix) an apparent viscosity of about 100,000 cP to about 500,000 cP. 12 Ex. 1009, ¶ 00049. 13 Otonomy points to this description as describing a method of treating an ear 14 infection by administering intratympanically a multiparticulate antimicrobial 15 agent in a specific type of tri-block polymer with a concentration of about 20% by 16 weight and a gelation temperature above 15 ºC. The tri-block polymer is said to be 17 poloxamer 407. Multiparticulate is urged to mean suspended. Paper 54, 7-8, citing 18 Ex. 1039 ¶44. 19 We accept Dr. Salt’s testimony concerning the tri-block polymer being 20 poloxamer 407 and the multiparticulate antimicrobial as equating to suspended. It 21 is logical, supported, and reasonable. Ex. 1039, ¶¶45–47. Thus, so far as we can 22 tell, the only remaining selection to be made to meet an embodiment within the 23 count is a choice of type of antibiotics. Otonomy points to Ex. 1006, ¶ 0142 as 24 support for the choice of fluoroquinolones. 25 26 [00142] Because OM can be caused by a virus, bacteria or both, it is often 27 difficult to identify the exact cause and thus the most appropriate treatment. 28 Treatment options for OM include antibiotics, such as penicillins (e.g., 29 Interference 106,030 Motions Decision 45 amoxicillin and amoxicillin-clavulanate ), clavulanate acid, 1 trimethoprimsulfamethoxazole, fluoroquinolone (e.g., ofloxacin, 2 ciprofloxacin, levofloxacin, trovafloxacin), cephalosporins (e.g., cefuroxime, 3 ceflacor, cefprozil, loracarbef, cefindir, cefixime, cefpodoxime proxetil, 4 cefibuten, and ceftriaxone), macrolides and azalides (e.g., erythromycin, 5 clarithromycin, and azithromycin), sulfonamides, and combinations 6 thereof… 7 8 Ex. 1009 and Ex. 1006, ¶ 00142. 9 10 Dr. Salt testifies that a person of ordinary skill in the art would have 11 understood how to formulate the composition for the disclosed properties. Ex. 12 1039, ¶ 49. He further points to Example 7 of the disclosure of the ‘127 13 application. Id., 52. See also Ex. 1006, ¶¶ 132–133. 14 Auris opposes Otonomy’s request for relief, as discussed above. Paper 100. 15 We have considered their criticism of Drs. Salt and Mikulec, including reviewing 16 their cross-examinations, and have accordingly attributed less weight to their 17 testimony, and principally relied upon the written evidence of record. 18 Auris observes that the arguments and evidence do not set forth the 19 appropriate tests for enablement and written description. Id., 5–7. Otonomy 20 correctly points out that the Board requested minimizing discussion of issues 21 routinely handled by the Board. Paper 142, citing Paper 29, 11. 22 We have considered these criticisms, and nonetheless find that the 23 description in Ex. 1006 describes an enabled embodiment of the count. The only 24 significant choice to be made is the particular antibiotic, and there is a working 25 example of how to prepare a poloxamer with a suspension of a fluoroquinolone. 26 Accordingly, we conclude that Otonomy has met its burden as regards the 27 nonprovisional applications. 28 Interference 106,030 Motions Decision 46 Otonomy Motion 6 is therefore granted in part. 1 VI. Order 2 Auris Motion 1 is granted and priority benefit of U.S. Application 3 11/992,632, filed 26 March 2008 and International Application 4 PCT/EP2005/010478, filed 28 September 2005, is accorded Auris. 5 Auris Motion 2 is denied. 6 Otonomy Motion 1 is denied. 7 Otonomy Motion 2 is granted in part. Auris involved claims 1-8 are held 8 unpatentable as lacking written descriptive support for treating any middle or inner 9 ear disease with fluoroquinolone. Otonomy Motion 2 is denied as to Auris claim 9. 10 Otonomy Motion 6 for priority benefit is granted as to application 11 13/645,126, filed 4 October 2012; application 12/506,127, filed 20 July 2009; and 12 application 12/466,310, filed 14 May 2009; and denied as to provisional 13 application 61/140,033, filed 22 December 2008; provisional application 14 61/101,112, filed 29 September 2008; provisional application 61/094,384, filed 4 15 September 2008; and provisional application 61/083,871, filed 25 July 2008. 16 As a consequence of this decision, the order of the parties has changed. A 17 redeclaration therefore accompanies this decision. 18 Otonomy’s priority statement lists its earliest conception as July 25, 2008. 19 As a further consequence of this decision, Otonomy cannot overcome Auris 20 accorded priority benefit. Therefore, judgment on priority accompanies the 21 redeclaration. 22 Interference 106,030 Motions Decision 47 Attorney for Auris Medical, AG: Michael Tuscan, Ph.D. Bonnie Weiss McLeod, Ph.D. Cooley, LLP Email: mtuscan@cooley.com Email: bweissmcleod@cooley.com Email: zpatdcdocketing@cooley.com Attorney for Otonomy, Inc.: Michael T. Rosato Michael J. Hostetler Richard Torczon Wilson Sonsini Goodrich & Rosati Email: mrosato@wsgr.com Email: mhostetler@wsgr.com Email: rtorczon@wsgr.com

Lichter et al. V. Meyer