Sasai et al.v.Bergendahl et al.Download PDFPatent Trial and Appeal BoardJun 29, 201612442245 (P.T.A.B. Jun. 29, 2016) Copy Citation BoxInterferences@uspto.gov Filed: June 29, 2016 571-272-7822 UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD VEIT BERGENDAHL and JAMES A. THOMSON, Junior Party, (Patent 7,892,830) v. YOSHIKI SASAI and KIICHI WATANABE, Senior Party, (Application 12/442,245) Patent Interference No. 106,009 (Technology Center 1600) Before: RICHARD E. SCHAFER, SALLY GARDNER LANE, and DEBORAH KATZ, Administrative Patent Judges. LANE, Administrative Patent Judge. JUDGMENT - Bd. R. 127(a) Interference 106,009 -2- A decision granting junior party Bergendahl’s motion on the basis of priority 1 and denying both senior party Sasai’s motion for judgment on the basis of priority 2 and its motion for judgment that the Bergendahl involved claims are unpatentable 3 over prior art has been entered. (Decision on Priority and Other Motions, 4 Paper 258). In view of the Decision, judgment on priority is entered against Sasai. 5 Order 6 It is 7 ORDERED that judgment on priority is entered against senior party Sasai as 8 to Count 1, the sole Count of the interference (Declaration, Paper 1, at 4); 9 FURTHER ORDERED that claims 1, 5-10, 17 and 18 of Sasai application 10 12/442,245, which correspond to Count 1, are FINALLY REFUSED. 35 U.S.C. 11 § 135(a);1 12 FURTHER ORDERED that the parties are directed to 35 USC § 135(c) and 13 Bd. R. 205 regarding the filing of settlement agreements; 14 FURTHER ORDERED that a party seeking judicial review timely serve 15 notice on the Director of the United States Patent and Trademark Office. 16 37 C.F.R. §§ 90.1 and 104.2. See also Bd. R. 8(b). Attention is directed to Biogen 17 Idec MA, Inc., v. Japanese Foundation for Cancer Research, 785 F.3d 648, 18 654–57 (Fed. Cir. 2015) (determining that pre-AIA § 146 review was eliminated 19 for interference proceedings declared after September 15, 2012); and 20 1 Any reference to a statute in this Judgment is to the statute that was in effect on March 15, 2013 unless otherwise indicated. See Pub. L. 112-29, § 3(n), 125 Stat. 284, 293 (2011). Interference 106,009 -3- FURTHER ORDERED that a copy of this judgment be entered into the 1 administrative records of the involved Bergendahl patent and Sasai application. 2 3 4 5 6 7 cc (via electronic transmission): 8 9 Attorney for Bergendahl: 10 11 Kevin E. Noonan 12 Sarah E. Fendrick 13 Michelle L. McMullen-Tack 14 McDONNELL BOEHNEN HUBERT & BERGHOFF LLP 15 16 noonan@mbhb.com 17 fendrick@mbhb.com 18 mcmullen-tack@mbhb.com 19 20 Attorney for Sasai: 21 22 John Kilyk, Jr. 23 Bruce M. Gagala 24 M. Daniel Hefner 25 LEYDIG VOIT & MAYER LTD. 26 27 jkilyk@leydig.com 28 bgagala@leydig.com 29 dhefner@leydig.com 30 31 BoxInterferences@uspto.gov Filed: June 29, 2016 571-272-7822 UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD VEIT BERGENDAHL and JAMES A. THOMSON, Junior Party, (Patent 7,892,830) v. YOSHIKI SASAI and KIICHI WATANABE, Senior Party, (Application 12/442,245) Patent Interference No. 106,009 (Technology Center 1600) Before: RICHARD E. SCHAFER, SALLY GARDNER LANE, and DEBORAH KATZ, Administrative Patent Judges. LANE, Administrative Patent Judge. Decision –Priority and other motions – Bd. R. 121(a) 2 I. Introduction 1 The interference was declared on 14 August 2014 between junior party Veit 2 Bergendahl and James A. Thomson (Bergendahl) and senior party Yoshiki Sasai 3 and Kiichi Watanabe (Sasai) (Declaration, Paper 1). 35 U.S.C. § 135(a).1 4 In the Decision on non-priority motions (Decision on non-priority motions, 5 Paper 144), Bergendahl Motion 1 for judgment on the basis that all the involved 6 Sasai claims are unpatentable for failing to comply with the written description and 7 enablement requirement of 35 U.S.C. § 112, ¶ 1 and Bergendahl Motion 2 seeking 8 as relief that the current Count, Count 1, be substituted, were denied. The only 9 Sasai Motion, Sasai Motion 1, seeking judgment on the basis that all the involved 10 Bergendahl claims are unpatentable over cited prior art (Sasai Motion 1, Paper 47) 11 and the Bergendahl Motion responsive to that Sasai Motion (Bergendahl Motion 12 3,2 Paper 90, seeking to add Bergendahl reissue application 14/579,493 to the 13 interference) were deferred. (Decision on non-priority motions at 3). 14 After the Decision on non-priority motions, Bergendahl and Sasai each filed 15 a motion for judgment on the basis of priority of invention (Bergendahl Priority 16 Motion3, Paper 179 and Sasai Priority Motion, Paper 183). Each party filed an 17 1 Any reference to a statute in the Decision is to the statute that was in effect on March 15, 2013 unless otherwise indicated. See Pub. L. 112-29, § 3(n), 125 Stat. 284, 293 (2011). 2 While Bergendahl styled this motion as “Responsive Motion 1” it should have been styled “Motion 3”. As we noted in our earlier Decision (Decision, Paper 144 at 2, fn. 3), we refer to it as if styled as required by the Standing Order. (See Standing Order (SO), Paper 2, at ¶ 121.1.) 3 Bergendahl timely filed its priority motion (at Paper 178). Thereafter Bergendahl was authorized to file, and did file, a corrected priority motion to correct minor defects. (Order, Paper 182, corrected Priority Motion at 179). As required by the Order Bergendahl filed an appendix (Appendix 3, list of 3 opposition to its opponent’s priority motion (Bergendahl Opposition, Paper 230 1 and Sasai Opposition, Paper 231) and corresponding replies (Bergendahl Reply, 2 Paper 238 and Sasai Reply, Paper 239). 3 In addition, Bergendahl filed a miscellaneous motion to exclude evidence 4 relied upon by Sasai in the Sasai Priority Motion and the Sasai Opposition to the 5 Bergendahl Priority Motion. (Motion to exclude, Paper 247). Thus we have before 6 us a priority motion from each party as well as the Bergendahl motion to exclude 7 and the non-priority motions that were deferred.4 8 We grant the Bergendahl Priority Motion, deny the Sasai Priority Motion, 9 dismiss as moot the Bergendahl motion to exclude, deny Sasai Motion 1 and deny 10 Bergendahl Motion 3. 11 12 II. Findings of Fact 13 The record supports the following findings of fact, as well as any other 14 findings of fact set forth in this decision, by a preponderance of the evidence. 15 1. Junior party Bergendahl is involved in the interference on the basis of its 16 patent 7,892,830 issued on 22 February 2011 from application 12/016,066, filed 17 17 January 2008. (Declaration, Paper 1, at 3). 18 2. Senior party Sasai is involved in the interference on the basis of its 19 application 12/442,245, filed 13 July 2009. (Declaration, Paper 1, at 3). 20 corrections) to the corrected priority motion listing the modifications from the original priority motion. When we refer to the “Bergendahl Priority Motion” in this decision we are referring to the corrected priority motion. 4 The parties requested oral argument. (Bergendahl at Paper 246 and Sasai at Paper 248). After reviewing the parties’ filings, we have determined that oral argument is not necessary to reach a decision on the issues presented. 4 3. Bergendahl identifies its real party in interest as the Wisconsin Alumni 1 Research Foundation. (Bergendahl Notice of Real Party, Paper 5). 2 4. Sasai identifies its real party in interest as RIKEN. (Sasai Notice of Real 3 Party, Paper 12). 4 5. Count 1 is the sole count of the interference and is claim 1 of the involved 5 Sasai application, which is: 6 A method of culturing human, pluripotent stem cells, which comprises 7 treating the stem cells with a ROCK (Rho-kinase) inhibitor. 8 9 (Declaration, Paper 1, at 4). 10 11 6. Human embryonic stem cells, which may be abbreviated herein as “hES” 12 cells, “hESCs” or “human ES cells”, are human, pluripotent stem cells. 13 (Declaration of Palecek,5 Ex. 2090, at ¶ 7). 14 7. A stem cell that is “pluripotent” has unlimited proliferation capacity. 15 (Exhibit 2090, at ¶6). 16 8. Sasai claim 1, and thus the Count, includes treating human, pluripotent stem 17 cells with a ROCK inhibitor “without limitation so long as an inhibitor can inhibit 18 the function of Rho-kinase (ROCK)…” (Decision on non-priority motions, Paper 19 144, at 8, referring to Sasai specification, Ex. 2004, at 12:19-10). 20 9. Sasai claim 1, and thus the Count, is not construed as requiring ROCK 21 inhibitors that achieve certain benefits disclosed in the Sasai specification, i.e., 22 improved survival rate, proliferation potency and/or differentiation efficiency. 23 (Decision on Motions, Paper 144, at 6-7). 24 5 In the Decision on non-priority motions, we found Dr. Palecek qualified to testify about issues relevant to the subject matter of this interference. (Paper 144 at 5:1-5). 5 10. The parties were accorded the following benefit as to Count 1 (earliest date 1 for each party in bold): 2 Bergendahl: US 60/880,747, filed 17 January 2007 3 4 Sasai: PCT/GB07/03636, filed 24 September 2007 5 JP 2007118183, filed 27 April 2007 6 UK 0710095.1, filed 25 May 2007 7 JP 2006257780, filed 22 September 2006 8 9 (Declaration, Paper 1, at 5). 10 11. All the claims of each party correspond to Count 1. 11 (Declaration, Paper 1, at 4). 12 12. In its priority statement Bergendahl asserts 16 September 2005 as both its 13 earliest corroborated conception date and its earliest corroborated actual reduction 14 to practice date. (Bergendahl Priority Statement, Paper 28, at 1). 15 13. Bergendahl also asserts 16 September 2005 as its earliest corroborated date 16 on which diligence began. (Bergendahl Priority Statement, Paper 28, at 1). 17 14. In its priority statement Sasai asserts 4 March 2005 as its earliest 18 corroborated conception date and 2 October 2005 its earliest corroborated actual 19 reduction to practice date. (Sasai Priority Statement, Paper 32, at 1). 20 15. Sasai asserts 4 March 2005 as its earliest corroborated date on which 21 diligence began. (Sasai Priority Statement, Paper 32, at 1). 22 6 III. Discussion 1 A. Priority Motions 2 In its priority motion junior party Bergendahl argues that it simultaneously 3 conceived and reduced to practice an invention of the Count on 16 September 4 2005. Bergendahl further argues that it had additional conceptions coupled with 5 reductions to practice between October of 2005 and April of 2007. (Bergendahl 6 Priority Motion, Paper 179, at 3 and 24) but does not assert diligence. 7 In its priority motion Sasai argues that it conceived of an embodiment of the 8 Count “prior to” 16 September 2005 and “as early as” 4 March 2005. Sasai argues 9 that it thereafter reduced to practice the embodiment by 4 October 2005. Sasai 10 asserts that it was diligent between 15 September 2005 and 4 October 2005. (Sasai 11 Priority Motion, Paper 183, at 3, 9 and 17). 12 The Board may take up motions for decision in any order and may take such 13 other action appropriate to secure the just, speedy, and inexpensive determination 14 of the proceeding including deferral of action on an issue until a later point in the 15 proceeding. Bd. R. 125(a). The party filing the motion has the burden of proving 16 that it is entitled to relief requested in the motion. Bd. R. 121(b). 17 “Priority is generally awarded to the applicant who was first to reduce the 18 invention to practice; however, an applicant who was first to conceive the 19 invention but last to reduce it to practice will be awarded priority if he 20 demonstrates reasonable diligence in his reduction to practice.” Cooper v. 21 Goldfarb, 240 F.3d 1378, 1382 (Fed. Cir. 2001) (citing 35 U.S.C. § 102(g)). 22 7 We first consider the Bergendahl Priority Motion. 1 1. Bergendahl Priority Motion 2 Bergendahl argues that it simultaneously conceived and reduced to practice 3 an invention of the Count on 16 September 2005, a date prior to Sasai’s earliest 4 accorded benefit date of 22 September 2006. (Bergendahl Priority Motion 1 at 3, 5 Declaration, Paper 1, at 3). 6 “The doctrine of simultaneous conception and reduction to practice is 7 somewhat rare but certainly not unknown, especially in the unpredictable arts such 8 as chemistry and biology.” Mycogen Plant Science v. Monsanto, 243 F.3d 1316, 9 1330 (Fed. Cir. 2001), citing Burroughs Wellcome Co. v. Barr Labs., Inc., 40 F.3d 10 1223, 1228–29, (Fed.Cir.1994); Amgen, Inc., 927 F.2d at 1206,; Smith v. Bousquet, 11 111 F.2d 157, 159 (1940). 12 To prove conception it must be shown that the inventors formed a definite 13 and permanent idea of the complete and operative invention as it is to be applied in 14 practice. Coleman v. Dines, 754 F.2d 353, 359 (Fed.Cir.1985). “Conception is 15 complete only when the idea is so clearly defined in the inventor’s mind that only 16 ordinary skill would be necessary to reduce the invention to practice, without 17 extensive research or experimentation.” Burroughs Wellcome Co. v. Barr Labs., 18 Inc., 40 F.3d 1223, 1228 (Fed. Cir. 1994). 19 An actual reduction to practice occurs when an inventor constructs an 20 embodiment or performed a process that met all the limitations of the interference 21 count and determines that the invention works for its intended purpose. Cooper v. 22 Goldfarb at 1382 (citing UMC Elecs. Co. v. United States, 816 F.2d 647, 652 23 (Fed.Cir.1987) (“[T]here cannot be a reduction to practice of the invention ... 24 without a physical embodiment which includes all limitations of the claim.”) and 25 8 Estee Lauder Inc. v. L'Oreal S.A., 129 F.3d 588, 593, (Fed.Cir.1997) (“[A] 1 reduction to practice does not occur until an inventor, or perhaps his agent, knows 2 that the invention will work for its intended purpose.”). 3 According to Bergendahl, in March of 2005 Bergendahl inventors 4 Dr. Bergendahl and Dr. Thomson began using high throughput screening in an 5 effort to identify compounds that promote clonal growth of pluripotent human 6 embryonic stem cells. Dr. Bergendahl is said to have cultured stem cells with 7 thousands of small molecules some of which were ROCK inhibitors. On 16 8 September 2005 Bergendahl asserts that Dr. Bergendahl identified a particular 9 ROCK inhibitor HA-100 (also known as 1-(5-isoquinolinesulfonyl) piperazine 10 hydrochloride), which he found to be capable of promoting clonal growth of 11 pluripotent stem cells in culture. According to Bergendahl, it was on this date that 12 Dr. Bergendahl had a definite and permanent idea of culturing stem cells with HA-13 100 and successfully performed the method to promote clonal human stem cell 14 growth with HA-100. In other words, according to Bergendahl, both its conception 15 and reduction to practice occurred on this date. (Bergendahl Priority Motion at 3). 16 In support of its arguments for simultaneous conception and reduction to 17 practice on 16 September 2005, Bergendahl directs us to testimony from inventor 18 Bergendahl (Ex. 2059), and what is said to be corroborating evidence including 19 testimony from non-inventors Megan Stone (Ex. 2060), Jessica Antosiewicz-20 Bourget (Ex. 2061), and Paulanne Chelf (Ex. 2064). 21 Within its Priority Motion, Bergendahl provides a thorough discussion of the 22 evidence relied upon to show conception and reduction to practice including the 23 testimony from Dr. Bergendahl, Ms. Stone, Ms. Antosiewicz-Bourget, and 24 Ms. Chelf. Below we summarize a portion of what that evidence shows. 25 9 Dr. Bergendahl joined the laboratory of co-inventor Dr. Thomson as a 1 Senior Scientist to initiate research of screening small molecule libraries to identify 2 an agent capable of promoting clonal growth of human pluripotent stem cells. 3 (Ex. 2059 at ¶¶20 and 21). In performing their research Dr. Bergendahl and Dr. 4 Thomson made use of the Small Molecule Screening Facility (SMSF), a service 5 resource available to researchers at the University of Wisconsin-Madison. (Ex. 6 2059 at ¶ 9) 7 Ms. Stone worked as an associate research assistant at SMSF and assisted 8 Dr. Bergendahl in conducting screening assays through the spring and summer of 9 2005. (Ex. 2060 at ¶ 3). They used high throughput methods to culture stems cells 10 with a library of compounds that included ROCK inhibitors. These efforts 11 between April and August of 2005 were beset with technical difficulties and were 12 not successful. (Ex. 2059 at ¶¶ 62-81 and Ex. 2060 at ¶¶ 77-80). On 16 September 13 2005 Dr. Bergendahl performed a successful method of culturing human 14 embryonic stem cells in the presence of HA-100 and contemporaneously recorded 15 this in his signed and dated notebook. (Ex. 2059 at ¶¶ 106-108; Ex. 2082; Ex. 16 2084, Ex. 2061 at 17 ¶ 11.) He further testified that he communicated the results of the work to Dr. 18 Thomson on that date. (Ex. 2059 at ¶ 113.) 19 Ms. Stone testifies that she assisted with, witnessed and recorded Dr. 20 Bergendahl’s successful method of culturing the human ES cells in the presence of 21 HA-100 on 16 September 2005. (Ex. 2060 at ¶¶ 91-96; Ex. 2059 at ¶¶ 100-108; 22 Ex. 2078, Ex. 2060 at ¶¶ 25-38, 58, 59; Ex. 2062 at ¶¶ 10-14; Ex. 2077). 23 Ms. Antosiewicz-Bourget testifies that she was the lab manager for the 24 Thomson lab (Exhibit 2061, ¶¶ 3-4) and that she recalls that in late 2005 or early 25 10 2006 Dr. Bergendahl communicated that he had successfully performed a method 1 of promoting clonal growth of human stem cells in the presence of a small 2 molecule. (Ex. 2061 at ¶¶ 21-30; Ex. 2059 at ¶ 114). Ms. Antosiewicz-Bourget 3 testifies that she was the custodian of the Thomson Lab ordering records and that 4 she placed an order for HA-100, which was not a routine item she ordered, for Dr. 5 Bergendahl on 19 September 2005. (Ex. 2061 at ¶¶ 12-20, Ex. 2067). 6 Ms. Chelf testifies that in 2005 she was an Intellectual Property 7 Manager at the Wisconsin Alumni Research Foundation (WARF) and that on or 8 around 28 November 2005 she received an Invention Disclosure Report (IDR) 9 from Drs. Thomson and Bergendahl. (Ex. 2064 at ¶ 8; Ex. 2065). Dr. Bergendahl 10 testifies that he wrote and submitted the IDR to Ms. Chelf on behalf of himself and 11 Dr. Thomson. (Ex. 2059 at ¶¶ 138-143). The IDR appears to describe, inter alia, a 12 method of culturing stem cells in the presence of HA-100. (Ex. 2065; Ex. 2059 at 13 ¶¶ 112-113.) 14 Sasai admits that on 16 September 2005 that Dr. Bergendahl and Ms. Stone 15 inspected prepared micro-well plates and were able to visually confirm the 16 presence of a colony of pluripotent hESCs grown in a culture containing HA-100. 17 (Bergendahl Priority Motion 1, Appendix 2 at 5 and 6, SOFs6 39, 43-45, citing to, 18 e.g., Ex. 2059 at ¶ 104; Ex. 2060 at ¶ 96, admitted by Sasai in the Sasai 19 Opposition, Paper 231, at Appendix 2 at 9-10). 20 Sasai does not dispute that the relied upon evidence shows that 21 Dr. Bergendahl conceived of and reduced to practice, a method of culturing human 22 ES cells using HA-100 as of 16 September 2005. 23 6 Statement of facts. 11 Sasai contends though that despite the work with HA-100, Bergendahl did 1 not conceive or reduce to practice an invention of the Count because Bergendahl 2 did not prove that at the time it appreciated or recognized that HA-100 can inhibit 3 the function of Rho-kinase (ROCK) as required by the Count. In other words, 4 Sasai argues that Bergendahl must show that it appreciated at the time that HA-100 5 was a ROCK inhibitor to prove a complete conception and reduction to practice of 6 the Count. (Sasai Opposition at 7:12-16). Further Sasai argues that the 7 corroborated evidence Bergendahl cites in support of its Priority Motion contains 8 no indication that Bergendahl appreciated that stems cells were being treated with a 9 ROCK inhibitor until at least after Sasai’s accorded benefit date. Sasai argues that 10 “the first mention of the terms ‘Rho-kinase inhibitor’ or ‘ROCK-inhibitor’ in any 11 of the documentary exhibits created by Bergendahl and their assistants appear in 12 the laboratory purchase order records from 28 March 2007”. (Sasai Opposition at 13 7:15-8:6-10, referring to Ex. 2067 at 6, lines 4133 and 4134). 14 Sasai also points to a portion of the Bergendahl 60/880,747 (’747) benefit 15 application that states: 16 The molecules identified here which act as agents to increase the 17 efficacy of ES cell cloning were identified by a screen of small 18 molecules for this purpose. The mechanism by which these molecules 19 enhance the cloning efficiency of the culture of human ES cells in 20 [sic. is] unknown. Presumably the molecules interact with a signaling 21 kinase to promote a signaling pathway in the cells, but the identity of 22 the interaction and the pathway are not known at present. 23 24 (Sasai Opposition at 35-36, citing to Bergendahl US application 60/880,747 (’747, 25 Ex. 1002, at ¶ 00016). 26 12 Bergendahl has the burden of proving that it conceived and reduced to 1 practice an invention that met each limitation of the Count. Bd. R. 121(b); 2 207(a) (2). Showing a conception and reduction to practice of a species that falls 3 within the scope of the Count is sufficient. Oka v. Youssefyeh, 849 F.2d 581, 584 4 (Fed. Cir. 1989). 5 We agree with Sasai in that the evidence pointed out to us provides 6 insufficient indication that Dr. Bergendahl appreciated at the time he conceived 7 and reduced to practice the method of culturing human ES cells that HA-100 is a 8 ROCK inhibitor. The question before us is whether it matters that Dr. Bergendahl 9 did not recognize HA-100 as a ROCK inhibitor at that time even though 10 subsequently the literature reported it to be so. We think that in these 11 circumstances it does not. 12 According to Sasai, Bergendahl’s later recognition and appreciation of the 13 ROCK inhibitor feature cited in the Count amounts to a nunc pro tunc showing that 14 cannot be used to establish conception and reduction to practice. (Sasai Opposition 15 at 13:18-14:12, citing Estee Lauder, 129 F.3d at 593; Cooper, 154 F.3d at 1327-8; 16 Knorr v. Pearson, 671 F.2d at 1368,1375; Griffin v. Bertina, 285 F.3d 1029, 1034-17 1035 (Fed. Cir. 2002)). 18 The circumstances before us do not appear to present a case of nunc pro tunc 19 invention as in the cited cases. The cited Estee Lauder discusses “the principle that 20 a reduction to practice does not occur until the inventor has determined that the 21 invention will work for its intended purpose.” In Griffin v. Bertina the court held 22 that the inventors had not determined that the invention would work for its 23 intended purpose. Griffin at 1034 (“In this case, however, the Board's 24 determination that Griffin's evidence does not indicate that it appreciated the actual 25 13 correlation of the point mutation in the count with APC resistance and thus an 1 increased risk of thrombosis was not lacking in substantial evidence.”). The 2 evidence before us shows that Dr. Bergendahl appreciated that he had successfully 3 cultured human ES cells in the presence of HA-100 as of the asserted date. 4 Further we find the facts in Knorr to differ from those before us. In Knorr 5 the evidence indicated that the inventor did not conceive of a required structural 6 feature of a mechanical invention. The argument that the structural feature was 7 inherently present was not persuasive. Knorr, 671 F.2d at 1375. Here however 8 there is no missing feature or argument of inherency. The evidence indicates that 9 Dr. Bergendahl appreciated that HA-100, which is a ROCK inhibitor, promoted the 10 growth of human ES cells in culture. 11 Further we do not find this to be a case where the inventors did not 12 appreciate that the invention would work for its intended purpose as in the other 13 cases cited by Sasai. (Sasai Opposition at 11-14). While the evidence suggests 14 that the inventors did not appreciate at the time that the compound producing the 15 desired outcome (HA-100) was part of the group of compounds that inhibit ROCK, 16 this does not negate that the Bergendahl inventors identified HA-100 and realized 17 that it was useful to promote the growth of human ES cells in culture. 18 Dr. Bergendahl need not have used the term “ROCK-inhibitor” to describe the 19 obtained HA-100 to have invented a method of the Count. Mycogen Plant Science 20 v. Monsanto Co. 243 F.3d 1316, 1336 (Fed. Cir. 2001) (“The reduction to practice 21 test does not require in haec verba appreciation of each of the limitations of the 22 count.”) Silvestri v. Grant, 496 F.2d 593, 599, (CCPA 1974). (“This standard does 23 not require that Silvestri establish that he recognized the invention in the same 24 terms as those recited in the count. The invention is not the language of the count 25 14 but the subject matter thereby defined. Silvestri must establish that he recognized 1 and appreciated as a new form, a compound corresponding to the compound 2 defined by the count.”). 3 We note Sasai’s reliance on Invitrogen Corp. v. Clontech Laboratories, Inc. 4 429 F.3d 1052 (Fed. Cir. 2005) in support of its argument that Bergendahl was 5 required to have appreciated the ROCK inhibitor feature of the Count for a 6 reduction to practice to have occurred. (Sasai Opposition at 11). We are not 7 persuaded Invitrogen supports such a requirement in the circumstances before us. 8 In Invitrogen the evidence indicated that the inventor did not set out to find an RT 9 gene having, or realize that any of the 100 randomly mutated RT genes had, the 10 required function of being RNase H minus RT with DNA polymerase activity. 11 Invitrogen at 1066 (“There is no evidence that merely sequencing the mutant RT 12 gene could, in 1986, establish the corresponding enzyme's properties. More 13 fundamentally, the record is inconsistent with the district court's notion that Goff 14 set out to create RNase H minus RT, or that he recognized his invention in 1984. It 15 shows, instead, that this action fits squarely within the unrecognized, accidental 16 duplication cases.”) Instead the evidence before us indicates that Dr. Bergendahl 17 set out to find small molecules that would promote the growth of hES cells in 18 culture and recognized that HA-100 did so as of 16 September 2005. (See, e.g., 19 Bergendahl Priority Motion SOFs 9-11 and 30, admitted in Sasai Opposition, 20 Appendix 2 at 3 and 7). 21 We see the situation before us to be more akin to that of Teva 22 Pharmaceuticals Industries Ltd. v. Astrazenca Pharmaceuticals, LP, 661 F.3d 23 1378 (Fed. Cir. 2011), where the Court, in discussing some of the cases cited in 24 Sasai’s Opposition, stated: 25 15 Dow, [7] Mycogen Plant Science, and Invitrogen are consistent 1 applications of the same rule. To establish prior invention, the party 2 asserting it must prove that it appreciated what it had made. The prior 3 inventor does not need to know everything about how or why its 4 invention worked. Nor must it conceive of its invention using the 5 same words as the patentee would later use to claim it. 6 7 Teva, 661 F.3d at 1385. 8 Sasai also cites to Heard v. Burton, 333 F.2d 239 (CCPA 1964), to support 9 its argument. In Heard though the Court agreed that there is no requirement that 10 an inventor use the same language as found in the Count. Heard at 1507. (“We 11 agree with appellant that it is irrelevant that Heard never referred to or appreciated 12 the support material to be eta-alumina or to contain eta-alumina by that name…. 13 we consider it fatal to appellant's case that not until after appellees' filing date did 14 Heard recognize that his ‘ammonia-aged’ catalyst, as appellees put it, ‘contained 15 any different form of alumina at all.’”). Heard does not support a determination 16 that the Bergendahl inventors must have appreciated that HA-100 is a ROCK 17 inhibitor to have appreciated that HA-100 successfully promoted the growth of 18 human ES cells in culture. 19 Sasai argues that the only evidence Bergendahl points to establishing that 20 HA-100 was understood to be a ROCK inhibitor is the testimony of Dr. 21 Bergendahl which in turn refers to an article by Yu.8 (Sasai Opposition at 19-21). 22 The article by Yu, which identifies HA-100 as a ROCK inhibitor, contributes to 23 Dr. Bergendahl’s understanding and the knowledge of one skilled in the art that 24 HA-100 is a ROCK inhibitor. As that article did not publish until 2011 though the 25 7 Dow Chemical Co. v. Astro-Valcour, Inc. 267 F.3d. 1334 (Fed. Cir 2001). 16 evidence pointed out to us is insufficient to show that Dr. Bergendahl recognized 1 HA-100 to be a ROCK inhibitor in 2005. As explained above we do not think in 2 these circumstances that such recognition is a necessary requirement for 3 Bergendahl to have conceived and reduced to practice. 4 We are not persuaded by Sasai’s argument that the Yu reference is 5 speculative in characterizing HA-100 as a ROCK inhibitor. In this regard we agree 6 with Bergendahl that the relevant literature reports HA-100 as being a ROCK 7 inhibitor such that Bergendahl has met its burden to show it to be so. Sasai does 8 not direct us to evidence to the contrary. We agree with Bergendahl further that 9 information contained in the Product Information for HA-100 (Ex. 1063), 10 indicating it to have uses including being an inhibitor of other kinases, does not 11 preclude it having the art recognized activity of ROCK inhibition. Indeed, as 12 pointed out by Bergendahl, the Product Information cites to Mack et al. (2011) 13 (Ex. 2096) which states that “small molecules that included PD0325901, 14 CHIR99021, A-83- 01, and HA-100 … have been described previously as 15 inhibitors of MEK, GSK3b, TGFβ, and ROCK pathways, respectively….”. We 16 note that Sasai does not dispute, or provide evidence disputing, that HA-100 is a 17 ROCK inhibitor. We also note that, as further discussed below, Sasai inventor Dr. 18 Watanabe relies upon reported activity to support his assertion that he appreciated 19 a compound to be a ROCK inhibitor. (Declaration of Watanabe, Ex. 1027, at ¶ 32, 20 citing to Hirose, et al. Ex. 10539). 21 We are persuaded that Bergendahl simultaneously conceived and reduced to 22 practice an invention of the Count on 16 September 2005, a date prior to Sasai’s 23 8 Yu et al., PLOS ONE, 6(3) e17557: 1-10. (2011). (Ex. 1062). 9 Hirose et al., JCB 141:1625-1636 (1998). 17 earliest accorded benefit date of 22 September 2006. Sasai though asserts that it 1 conceived an invention of the Count earlier than 16 September 2005 and was 2 reasonably diligent in reducing to practice the invention. Accordingly we turn to 3 the Sasai Priority Motion. 4 5 2. Sasai Priority Motion 6 In support of its argument for conception, reduction to practice and 7 diligence, Sasai directs us to, inter alia, the testimony of inventor Dr. Watanabe 8 (Ex. 1027) .10 9 Dr. Watanabe testifies to the following sequence of events: 10 During the relevant time frame Dr. Watanabe worked as a research scientist 11 for RIKEN in Kobe, Japan within the Sasai lab, one of several research 12 laboratories within RIKEN, where he collaborated with Dr. Sasai. Dr. Watanabe at 13 times was assisted by laboratory staff that included Ms. Ayaka Nishiyama who 14 worked under his direction in, e.g., performing certain experiments. (Ex. 1027, at 15 ¶¶ 1-11). 16 In 2004 Dr. Watanabe and Dr. Sasai had developed a method for inducing 17 the differentiation of embryonic stem cells into neural tissue using a serum-free 18 suspension culture, commonly referred to as “SFEB” (Serum-free floating culture 19 of embryoid body-like aggregates). He and Dr. Sasai encountered difficulty in 20 culturing human ES cells particularly in comparison to mouse ES cells using the 21 SFEB method as the human ES cells were vulnerable to cell death upon cellular 22 detachment and dissociation from a substrate. (Ex. 1027, at ¶¶ 16-20). 23 10 We have been informed that the other Sasai inventor, Dr. Sasai, passed away in 2014. (Declaration of Watanabe, Ex. 1027, at ¶ 3). 18 During a 4 March 2005 monthly discussion meeting, he and Dr. Sasai 1 discussed using the ROCK inhibitor Y-27632 to suppress cell death induced by 2 detachment or dissociation, including, but not limited to, various kinds of stem 3 cells. After this meeting Dr. Watanabe order a 1 mg quantity of Y-27632 which 4 was received by 8 March 2005. (Ex. 1027, at ¶¶ 20-23). 5 Beginning on 24 August 2005 Dr. Watanabe and Dr. Hanako Ikeda (a 6 visiting scholar from Kyoto University) began an experiment involving 7 differentiation of human ES cells. Based on testing outlined further in his 8 testimony, Dr. Watanabe concluded that human ES cells were unstable relative to 9 mouse ES cells cultured under like conditions. Dr. Watanabe decided to use the 10 ROCK inhibitor Y-27632 to try to improve the survival of hES cells using the 11 differentiation protocol. (Ex. 1027 at ¶¶ 24-33). 12 As of 6 September 2005 Dr. Watanabe had decided to use the ROCK 13 inhibitor Y-27632 in a method of culturing pluripotent human ES cells and 14 reflected this in his notes. Dr. Watanabe had prior knowledge that Y-27632 was an 15 inhibitor of ROCK also as reflected in his notes (Ex. 1027 at ¶¶ 31 and 32; Ex. 16 1036). This knowledge of the ROCK inhibitor activity came from what had been 17 reported in the literature as of 1998. (Hirose, et al. Ex. 1053). 11 Before beginning 18 the work with Y-27632 Dr. Watanabe completed work he had begun with Ms. 19 Nishiyama and in particular a human ES differentiation protocol begun on 4 20 August 2005. (Ex. 1027, at ¶¶ 33-38). 21 In August, September and October of 2005, Dr. Watanabe was engaged in 22 activity involving culturing and passaging human ES cells (Ex. 1027 at ¶¶ 43-46). 23 11 As with Dr. Bergendahl in regard to HA-100, Dr. Watanabe relies upon reports in the literature to show Y-27632 to be a ROCK inhibitor. 19 Dr. Watanabe worked on passaging continuously from 17 August 2005 through 2 1 October 2005 when he obtained the 35th passage. He used Passage 35 cells for his 2 planned experiment with Y-27632. (Ex. 1027 at ¶¶ 43 and 46). 3 The experiment that Dr. Watanabe began on October 2, 2005, involved a 4 method of culturing hES cells to promote their differentiation by treating the hES 5 cells with Y-27632. Dr. Watanabe tested two different conditions, with or without 6 the ROCK inhibitor Y-27632. (Ex. 1027 at ¶¶ 46-48; Ex. 1029 at ¶ 15; Ex. 1041 at 7 1). 8 On 4 October 2005, Dr. Watanabe visually confirmed by inspection under a 9 microscope that treating cells with Y-27632 decreased the incidence of cell death 10 of the hES cells. (Ex. 1027, ¶ 49; Ex. 1041, at 4-5). Dr. Watanabe also stained 11 each of the control and test samples with Annexin V, a marker for apoptotic cells, 12 and analyzed the cells by FACS Aria. (Ex. 1027 at ¶ 50; Ex.1041 at 4-5). Results 13 revealed that 94.3% of the control cells, i.e., those cells not treated with ROCK 14 inhibitor Y-27632, were Annexin V positive meaning they were apoptotic, whereas 15 only 43.3% of the cells treated with Y-27632 were AnnExin V positive. (Ex. 1027, 16 at ¶ 50; Ex. 1041 at 5). 17 Dr. Watanabe recognized this as a dramatic outcome. The results confirmed 18 his and Dr. Sasai’s idea of using Y-27632 in the culturing of hES cells. (Ex. 1027, 19 at ¶ 51). 20 Conception 21 As we stated above proof of conception requires a showing that the 22 inventors formed a definite and permanent idea of the complete and operative 23 invention as it is to be applied in practice. Coleman v. Dines, 754 F.2d 353 at 359. 24 Each and every feature or limitation of the Count must be present in order to 25 20 establish a conception. Kridl v. McCormick, 105 F.3d 1446, 1449 (Fed. Cir. 1997). 1 2 Here Sasai argues that it conceived of an embodiment of the Count as 3 evidenced by the monthly discussion meeting on 4 March 2005 where inventors 4 Drs. Watanabe and Sasai discussed using ROCK inhibitor Y-27632 to suppress 5 cell death that occurs with detachment or dissociation, including, but not limited to, 6 various kinds of stem cells including human ES cells. (Sasai Priority Motion at 7 6:17-22). According to Sasai this discussion shows that the Sasai inventors had a 8 definite and permanent idea of culturing stem cells such as human ES cells by 9 treating them with a ROCK inhibitor. 10 4 March 2005 monthly discussion meeting 11 In support of its argument for conception Sasai relies upon the testimony of 12 Dr. Watanabe, summarized above. Sasai argues that as early as 4 March 2005 13 when the monthly discussion meeting occurred, the Sasai inventors conceived an 14 invention of the Count. 15 Sasai argues that “the testimony of Dr. Watanabe and Ms. Nishiyama, and 16 Ms. Nishiyama’s contemporaneous notes, establish that Drs. Watanabe and Sasai 17 discussed using ROCK (Rho-18 kinase) inhibitor Y-27632 to suppress cell death 18 that occurs with detachment or dissociation, including, but not limited to, various 19 kinds of stem cells, such as human embryonic stem cells.” (Sasai Priority Motion, 20 6:17-21, citing to, Ex. 1027 at ¶¶ 21 and 22, Ex. 1029 at ¶ 10 and Ex. 1034 at 3). 21 Sasai’s argument recognizes that a requirement of the Count is the culturing of 22 human pluripotent stem cells. 23 21 We have reviewed those portions of the testimony of Dr. Watanabe and 1 Ms. Nishiyama pointed out to us by Sasai as well as the notes of Ms. Nishiyama 2 from the 4 March 2004 meeting found at Ex. 1034. 3 Dr. Watanabe testified that he recalled that during the meeting he and 4 Dr. Sasai discussed using Y-27632 to suppress cell death induced by detachment of 5 dissociation of “various kinds of stem cells”. In his testimony Dr. Watanabe states 6 that Ms. Nishiyama’s handwritten notes on a handout from the meeting reflect 7 using ROCK inhibitor with respect to “human ES” and “human SFEB”. (Ex. 1027, 8 at ¶¶ 20-22.) However, we have not been directed to testimony by Dr. Watanabe 9 indicating a recollection that during this 4 March 2005 meeting he and Dr. Sasai 10 discussed using Y-27632 to culture human ES cells, in particular. 11 Similarly Ms. Nishiyama recalls being at the 4 March 2005 meeting where 12 there was a discussion of the use of a compound called Y-27632 “in the culture of 13 cells” by either Dr. Watanabe or Dr. Sasai. In her testimony Ms. Nishiyama refers 14 to her handwritten notes as reflecting this discussion. (Ex. 1029 at ¶ 10). However, 15 we have not been directed to testimony by Ms. Nishiyama indicating a recollection 16 that during the meeting Dr. Watanabe or Dr. Sasai discussed using Y 27632 in the 17 culture of human ES cells in particular. Ms. Nishiyama’s testimony corroborates 18 Dr. Watanabe’s that a meeting occurred where culturing of cells using Y-27632 19 occurred. However, we have not been directed to testimony where either Dr. 20 Watanabe or Ms. Nishiyama testify to recalling a discussion of an embodiment of 21 the Count which requires culturing of human ES cells in particular. 22 In contrast, Ms. Nishiyama testifies that at a monthly discussion meeting 23 held on 3 October 2005, she recalls that “the use of a compounds called Y-27632 24 in the culture of hES cells was discussed.” (Ex. 1029 at 19, emphasis added). Dr. 25 22 Watanabe also testifies to recalling discussion of the culturing of using Y-27632 to 1 prevent cell death in the culturing of hES cells at the 3 October 2005 meeting. (Ex. 2 1027 at ¶ 59). 3 The meeting handout from the 5 March 2005 meeting containing the 4 handwritten notes of Ms. Nishiyama is produced below in relevant part: 5 6 7 (Ex. 1034). 12 8 Possibly relevant to the issue before us are the top handwritten notations 9 “human ES” and “human SFEB” as well as the handwritten notations “Y-27632” 10 and “dispersion results in death →anoikis presence of cadherin signal ...” 11 12 We have reviewed the untranslated as well as the English translated version of the handout (which appears to be in Japanese). The handwritten notes appear to be partially in English in the untranslated version although the handwriting on the untranslated version filed with the Board is faint as shown above. 23 elsewhere in the handout. Sasai has not asserted that the other notations, or the 1 type-written portion of the handout, are relevant to our inquiry other than in 2 showing that a meeting occurred and we do not find them to be relevant otherwise. 3 We agree with Bergendahl that these notations alone are insufficient to 4 establish a complete and coherent statement of an idea of culturing human ES cells 5 using Y-27632. (Bergendahl Opposition at 11-12). The notations, which appear at 6 disparate places within the document, do not indicate that they are related to one 7 another nor do they mention the culturing of cells. We consider the notations in 8 combination with the testimony of Dr. Watanabe and Ms. Nishiyama. However, 9 we are not persuaded that the combination is sufficient to show a definite and 10 permanent idea of culturing human ES cells in the presence of Y-27632. 11 Y-27632 purchase order 12 Sasai also directs us to Dr. Watanabe’s purchase of 1 mg of Y-27632, which 13 was said to have been delivered on 8 March 2005 (Ex. 1027 at ¶ 23; Ex. 1035) as 14 showing conception. According to Sasai, the delivery receipt dated 8 March 2005, 15 for Dr. Watanabe’s order of 1 mg of Y-27632 (Ex. 1035), corroborates that 16 Dr. Watanabe placed an order for a known ROCK inhibitor compound 17 contemporaneously to the monthly discussion meeting of 4 March 2005, during 18 which the use of ROCK inhibitors, such as Y-27632, was discussed between 19 Drs. Sasai and Watanabe for culturing stem cells. (Sasai Priority Motion at 7-8). 20 While this evidence may somewhat corroborate what Dr. Watanabe and Ms. 21 Nishiyama testified to regarding using Y-27632 to culture various cells, it does not 22 show that the inventors had a definite and permanent idea to culture human 23 ES cells in particular in the presence of Y-27632. In fact, Dr. Watanabe’s 24 testimony (Ex. 1027 at ¶ 23) and notebook entry of 6 September 2005 (indicating 25 24 that Y-27632 “was used preveously on trial for FACS [fluorescence activated cell 1 sorting] sorting of mouse ES”) indicate that Y-27632 was used by Dr. Watanabe 2 for other purposes. (Ex. 1036 at 2). 3 Dr. Watanabe’s notebook entries 4 Sasai argues that further evidence of a conception is demonstrated by Dr. 5 Watanabe’s decision, upon the conclusion of a 6 September 2005 experiment, to 6 use the ROCK inhibitor Y-27632 in a method of culturing hES cells to try to 7 improve the survival of the cells. (Sasai Priority Motion at 6-8). Sasai relies upon 8 Dr. Watanabe’s testimony and notebook entries regarding his work with Dr. Ikeda 9 to establish a corroborated conception. However, we have not been directed to 10 testimony from Dr. Ikeda or other evidence independent of Dr. Watanabe that 11 would corroborate Dr. Watanabe’s testimony and notebook entries. 12 Dr. Watanabe testifies that he decided, on 6 September 2005, to use the 13 ROCK inhibitor Y-27632 in a method of culturing pluripotent hES cells to try to 14 improve the survival of hES cells in this protocol. (Ex. 1027 at ¶¶ 31 and 33). His 15 notebook entries which include, “Test Y-27632 (ROCK inhibitor) which was used 16 before on trial for FACS sorting of mouse ES” and “[t]hese are to be tested in the 17 next differentiation” are said to corroborate his testimony. (Ex. 1027 at ¶ 31; Ex. 18 1036). Dr. Watanabe’s notes are consistent with this testimony but do not, without 19 explanation from Dr. Watanabe of their meaning, show a definite and permanent 20 idea of an invention of the Count. Corroboration of Dr. Watanabe’s testimony 21 requires evidence that is independent of the inventor. Singh v. Brake, 222 F.3d 22 1362, 1367 (Fed. Cir. 2000) (“It is well-established that when a party seeks to 23 prove conception via the oral testimony of a putative inventor, that party must 24 proffer evidence corroborating that testimony.”) Dr. Watanabe’s unwitnessed 25 25 notebook does not meet this requirement since an inventor’s testimony in this 1 regard must be corroborated by independent evidence. “Independent corroboration 2 may consist of testimony of a witness, other than the inventor, to the actual 3 reduction to practice or it may consist of evidence of surrounding facts and 4 circumstances independent of information received from the inventor.” Reese v. 5 Hurst, 661 F.2d 1222, 1225 (CCPA 1981), citing Thurston v. Wulff, 164 F.2d 612, 6 617 (CCPA 1947). 7 In determining whether an inventor’s testimony is corroborated sufficiently 8 we apply a “rule of reason” analysis by evaluating all pertinent evidence to 9 determine the credibility of the inventor's testimony. However, there must be some 10 independent corroboration of the inventor’s testimony. See Reese, 661 F.2d 1222 11 at 1225 (“[A]doption of the ‘rule of reason’ has not altered the requirement that 12 evidence of corroboration must not depend solely on the inventor himself.”). As 13 we discussed above, “[t]he law does not impose an impossible standard of 14 “independence” on corroborative evidence by requiring that every point of a 15 reduction to practice be corroborated by evidence having a source totally 16 independent of the inventor; indeed, such a standard is the antithesis of the rule of 17 reason.” Knorr, 671 F.2d at 1374 18 In its Reply, Sasai argues that “Bergendahl is incorrect; physical evidence, 19 such as an inventor’s notebooks, ‘do[es] not require corroboration to demonstrate 20 the content of the physical evidence itself, namely that . . . experiments took place 21 on [dates indicated in the notebooks].’” (Sasai Reply at 10 citing Brown v. 22 Barbacid, 276 F.3d 1327, 1335, 1337 (Fed. Cir. 2002). We do not agree that 23 Brown supports a determination that Dr. Bergendahl’s testimony may be 24 corroborated by his own unwitnessed notes. The entire quote from Brown states 25 26 that “[t]hus, Brown's physical evidence, such as Dr. Reiss' notebooks and 1 autoradiographs, do not require corroboration to demonstrate the content of the 2 physical evidence itself, namely that FT assay experiments took place on 3 September 20 and 25, 1989. Conversely, however, the physical evidence in this 4 case may not single-handedly corroborate Dr. Reiss' testimony.” Brown, 276 F.3d 5 1327 at 1335. Brown went on to state that “…independent evidence must 6 corroborate Dr. Reiss' testimony of conception or actual reduction to practice. The 7 Board did not err in holding that an inventor's own unwitnessed documentation 8 does not corroborate an inventor's testimony about inventive facts.” Brown at 9 1335. 10 We have considered the combination of all the evidence pointed out to us by 11 Sasai, including, inter alia, the testimony of Dr. Watanabe, the testimony of Ms. 12 Nishiyama, the notations on the handout from the 5 March 2005 meeting, the Y-13 27632 purchase order, and Dr. Watanabe’s notebook entries of 6 September 2005 14 and apply a rule of reason to determine whether Sasai has set forth a corroborated 15 conception as of 6 September 2005. Even given that there may be a less stringent 16 requirement for corroborating conception (as opposed to an actual reduction to 17 practice) we are not persuaded that this evidence shows a corroboration of Dr. 18 Watanabe’s testimony regarding conception by 6 September 2005. Singh v. Brake, 19 222 F.3d 1362 at 1369 (“That case dealt with the standard of proof required to 20 corroborate a reduction to practice, a more stringent standard than that required to 21 corroborate a conception” ). We have not been directed to evidence, independent 22 of inventor Dr. Watanabe, corroborating Dr. Watanabe’s testimony. The evidence 23 of record that is independent of Dr. Watanabe does not establish that the Sasai 24 27 inventors has a definite and permanent idea of the operative invention as it is to be 1 applied in practice. 2 We note Bergendahl’s other argument that Sasai did not conceive or reduce 3 to practice an invention of the Count because Dr. Watanabe employed protocols 4 allowing for cell differentiation rather than maintaining the cells in a pluripotent 5 state. Bergendahl argues that the method of the Count requires that the cells do not 6 differentiate but instead remain pluripotent while in culture. (Bergendahl 7 Opposition at 3 and 16). Sasai argues that the method of the Count does not 8 require that the cells remain in a pluripotent state and that therefore cultures that 9 allow for differentiation of the cells are included in the Count. (Sasai Reply at 1-10 3). As we are not persuaded that Sasai has shown conception as of 6 September 11 2005 of an embodiment of either type of culture of human pluripotent cells using a 12 ROCK inhibitor, we need not and do not reach this argument. 13 Since Sasai has not shown either an earlier conception coupled with 14 diligence or an earlier reduction to practice than the reduction to practice 15 established in the Bergendahl Priority Motion, Sasai cannot prevail on priority. 16 We need not and do not consider whether Sasai has proven a reduction to practice 17 as of the date alleged or diligence. 18 We deny the Sasai Priority Motion. 19 20 B. Other Motions 21 1. Bergendahl miscellaneous motion 22 Bergendahl moves to exclude Exhibits 1034, 1035, 1036, 1041, 1045, 23 and 1046 relied upon in Sasai’s Priority Motion 1 as well as Exhibit 1041 relied 24 upon in Sasai’s Opposition to the Bergendahl Priority Motion on the grounds that 25 28 these exhibits do not meet the standards set forth in the Federal Rules of Evidence 1 403 and 901. 2 Exclusion of these exhibits would not change our decisions to grant the 3 Bergendahl Priority Motion and deny the Sasai Priority Motion. Accordingly, we 4 need not and do not consider the whether to grant the relief requested in the 5 Bergendahl Miscellaneous Motion. We dismiss the motion as moot. 6 2. Sasai Motion 1 7 Bergendahl asserts that additional conceptions and reductions to practice 8 occurred between late October of 2005 and April 2007. (Bergendahl Priority 9 Motion at 25-33). As discussed above, we conclude that Bergendahl has shown 10 that it conceived and reduced to practice an invention of the Count on 16 11 September 2005. Further we conclude that Sasai has not shown a conception 12 earlier than 13 16 September 2005. Accordingly we need not consider these additional 14 conceptions and reductions to practice to grant the Bergendahl Priority Motion. 15 However, we consider these additional conceptions and reductions to 16 practice where they are relevant to Sasai Motion 1. 17 Sasai argues that the Bergendahl claims are unpatentable under 35 U.S.C. 18 § 102(a) in light of Watanabe et al., “A ROCK Inhibitor Permits Survival of 19 Dissociated Human Embryonic Stem Cells,” Nature Biotechnology, 25(6): 681-20 686 (2007) (Watanabe, Ex. 1003)13, under 35 U.S.C. § 102(e) in light of 21 International Patent Application PCT/GB207/003636 filed 24 September 2007 22 (Sasai ’636, Ex. 1004) and under 35 U.S.C. § 103(a) in view of Watanabe and the 23 13 According to Sasai Watanabe was published on line on 27 May 2007 and published in print in June of 2007. 29 Sasai PCT given admitted prior art in the preamble of claim 8 of the ’830 Patent. 1 (Sasai Motion 1, Paper 47). 2 Sasai asserts, citing Bd. R. 207, that the relied upon prior art does not apply 3 to it since Sasai ’636 is not prior art to the claims of the involved Sasai as it is the 4 U.S. national phase of ’636 Sasai. As to Watanabe, Sasai asserts that, its earliest 5 effective filing date predates the publication of Watanabe. (Sasai Motion 1 at 11). 6 We deferred deciding Sasai Motion 1, citing LeVeen v. Edwards, 7 http://www.uspto.gov/sites/default/files/ip/boards/bpai/decisions/inform/4290_241.pdf). (Ex. 8 2055). This was because Bergendahl, as an alternate to its argument that it is 9 entitled to the benefit of its earlier filed application US 60/880,747 (’747) for the 10 full scope of its claims, requested deferral of the motion until the priority phase of 11 the interference. Bergendahl indicated that it would “establish its priority date for 12 the invention” along with its priority proofs. (Decision on non-priority motions, 13 Paper 144, at 13 and Bergendahl Opposition 1 at 1:13-18). 14 We consider Sasai Motion 1 in light of the evidence presented in Bergendahl 15 Priority Motion 1. In particular, Bergendahl alleges that it conceived and reduced 16 to practice various embodiments within the scope of the Count between 17 October 2005 and April 2007. (Bergendahl Priority Motion at 24). Most relevant 18 to the patentability issues raised in Sasai Motion 1 are the alleged reductions to 19 practice of HA-1077, Y-27632 and H-1152. 20 Watanabe was published in May 2007 and appears to disclose the culturing 21 of human ES cells using Y-27632 and HA-1077 (which we understand also to be 22 known as Fasudil). (Watanabe, Ex. 1003, at 1). Sasai ’636 was filed in September 23 of 2007 and appears to disclose Y-27632, HA-1077 and H-1152 in the culturing of 24 human ES cells. (’636 at 5). Sasai concedes that Bergendahl had a constructive 25 30 reduction to practice of HA-1077 by virtue of the Bergendahl ’747 application, 1 which has a filing date earlier than the Watanabe publication date and the ’636 2 filing date (Sasai Opposition at 30:9-19), so we need not and do not consider 3 whether Bergendahl has shown an actual earlier reduction to practice of the 4 claimed culturing method using HA-1077. 5 Bergendahl presented evidence in its Priority Motion that it reduced to 6 practice a method of culturing human ES cells using Y-27632 and H-1152 prior to 7 the publication date of Watanabe and the filing date of Sasai ’636. (Bergendahl 8 Priority Motion at 28 and 32). 9 The issue of priority before us in deciding Sasai Motion 1 concerns the 10 antedating of references which is related to, but differs from, the interference 11 priority inquiry. Here if Bergendahl can show that it reduced to practice to 12 practice the disclosed embodiments prior to the publication date of Watanabe and 13 the filing date of Sasai ’636 then that is sufficient to negate these references as 14 prior art under 35 U.S.C. §§ 102(a) and 102(e), respectively. To do so Bergendahl 15 must show that the embodiment relied upon as evidence of priority actually worked 16 for its intended purpose. In re Steed, 802 F.3d 1311, 1316 (Fed. Cir. 2015) (“The 17 purpose [of antedating a reference] is not to determine priority of invention—the 18 province of the interference practice—but to ascertain whether the applicant was in 19 possession of the claimed invention sufficiently to overcome the teachings and 20 effect of an earlier publication of otherwise invalidating weight” and citing e.g., 21 Holmwood v. Sugavanam, 948 F.2d 1236, 1238 (Fed.Cir.1991) (“[A]n applicant 22 must show that ‘the embodiment relied upon as evidence of priority actually 23 worked for its intended purpose.’ ”). As we have already noted, “an inventor's 24 31 testimony must be corroborated by independent evidence to establish an earlier 1 reduction to practice.” Cooper v. Goldfarb, 154 F.3d at 1330. 2 Bergendahl argues that it reduced to practice a method of culturing human 3 ES cells in the presence of H-1152 and Y-27632 no later than 27 April 2007. 4 Bergendahl directs us to evidence similar to that discussed above regarding the 5 reduction to practice much of which is uncontested by Sasai. (Bergendahl Priority 6 Motion at 32 and SOFs 74-77 and Sasai Opposition, Appendix 2 at 19-20 7 admitting in part SOFs 74-77). 8 Sasai argues though that Bergendahl has not proven an earlier reduction to 9 practice using either H-1152 or Y-27632 in the claimed method such that at least 10 Bergendahl claims 1 and 4-8 are unpatentable in view of Watanabe and Sasai ’636. 11 In particular Sasai argues that while Dr. Bergendahl testified to an appreciation 12 that the invention worked for its intended purpose that testimony is not sufficiently 13 corroborated. (Sasai Opposition at 37-38). 14 Bergendahl directs us to, inter alia, the testimony of Mitchell Probasco, an 15 associate research specialist at the Thomson lab who assisted Dr. Bergendahl 16 during the relevant time frame, as corroboration of the testimony of Dr. Bergendahl 17 regarding these additional reductions to practice. (Probasco Decl., Ex. 2063 at 18 ¶¶ 3-6). 19 Sasai argues that the testimony of Mr. Probasco does not corroborate 20 Dr. Bergendahl’s testimony regarding his appreciation that the invention worked 21 for its intended purpose. Accordingly, Sasai argues, Bergendahl has not 22 established reductions to practice earlier than the publication date of Watanabe or 23 the filing date of Sasai ’636. 24 Sasai argues that: 25 32 While Party Bergendahl alleges that “Dr. Bergendahl and 1 Mr. Probasco both testify that Mr. Probasco communicated the result 2 of the assay on or around April 27, 2007” (BCPM, p. 33, 17 ll. 8-10, 3 emphasis added), in response, Party Sasai states that the evidence does 4 not support this assertion. Mr. Probasco’s testimony does not state that 5 he communicated anything to Dr. Bergendahl on or around 6 April 27, 2007; rather, Mr. Probasco testifies that he “saved the 7 experimental results (i.e., the actual plates) for Dr. Bergendahl’s 8 review and analysis.” (Exhibit 21 2063, ¶ 35, citing Exhibit 2072, p. 9 154). The cited exhibit, Mr. Probasco’s laboratory notebook (Exhibit 10 2072, p. 154) similarly, only states, “Plates are saved on bench.” 11 Mr. Probasco’s laboratory notebook does not say the test results were 12 in any way communicated to Dr. Bergendahl. Merely saving culture 13 plates on a laboratory bench, moreover, does not demonstrate actual 14 communication of any results to Dr. Bergendahl. The laboratory 15 notebook and Mr. Probasco’s testimony undercut Party Bergendahl’s 16 allegation that Mr. Probasco communicated the results of the assay to 17 Dr. Bergendahl “on or around April 27, 2007.” 18 19 (Sasai Opposition at 38:16-39:5). 20 Our review of the record indicates that Mr. Probasco testified that he 21 performed testing H-115214 and Y-27632 on 27 April 2007 and that he “saved the 22 experimental results (i.e., the actual plates) for Dr. Bergendahl’s review and 23 analysis” (Ex. 2063 at ¶ 35, citing to Ex. 2072 at 154). Further Mr. Probasco 24 testified that he performed additional testing of H-1152 and Y-27632 on 25 4 May 2007. Mr. Probasco’s lab notebook indicates that the plates from this 26 testing “are saved (on bench).” (Ex. 2072 at 156). Dr. Bergendahl testified that 27 14 In his notebook Mr. Probasco refers to Y-27632 and “Rho-Kinase Inhibitor”. As explained in this testimony, the latter refers to H-1152 which was purchased on 33 Mr. Probasco “communicated the results” of the testing of H-1152 and Y-27632 1 and that Dr. Bergendahl “personally inspected the data” on or around 4 May 2007. 2 (Ex. 2059 at ¶ 166). We agree that there is no statement from Mr. Probasco that he 3 verbally communicated the results of either the 27 April 2007 or the 4 May 2007 4 testing to Dr. Bergendahl. Mr. Probasco testified though that his bench was 5 adjacent to Dr. Bergendahl’s (Ex. 2063 at ¶5) and that he left plates, which both 6 Mr. Probasco and Dr. Bergendahl testify show successful results, for Dr. 7 Bergendahl to inspect. (Ex. 2063 at ¶35, Ex. 2072, Ex. 2075, and Ex 2050 at ¶167). 8 We understand this to be how Mr. Probasco communicated the results to Dr. 9 Bergendahl. As we noted above in discussing the rule of reason, “[t]he law does 10 not impose an impossible standard of “independence” on corroborative evidence 11 by requiring that every point of a reduction to practice be corroborated by evidence 12 having a source totally independent of the inventor; indeed, such a standard is the 13 antithesis of the rule of reason.” Knorr, 671 F.2d at 1374. We conclude that Dr. 14 Bergendahl’s testimony that he appreciated the results obtained by Mr. Probasco is 15 sufficiently corroborated by Mr. Probasco’s testimony and documentation cited in 16 that testimony. 17 Sasai further argues that the knowledge of Mr. Probasco regarding test 18 results does not inure to Dr. Bergendahl’s benefit. (Sasai Opposition at 40). 19 “Inurement involves a claim by an inventor that, as a matter of law, the acts of 20 another person should accrue to the benefit of the inventor.” Cooper, 154 F.3d at 21 1331. Sasai cites to Genentech, Inc. v. Chiron Corp., 220 F.3d 1345 (Fed. Cir. 22 2000), for the proposition that Mr. Probasco’s activities do not inure to the benefit 23 of Dr. Bergendahl. 24 the same day as the Y-27632. (Ex. 2063 at ¶32 and Ex. 2067 at 6). 34 First we do not think inurement is necessary to show that Dr. Bergendahl 1 appreciated the successful results. Dr. Bergendahl testified that he appreciated that 2 the test results for H-1152 and Y-27632 showed that culturing with these ROCK 3 inhibitors promoted clonal growth of human ES cells. We conclude, using a rule 4 of reason, that Dr. Bergendahl’s testimony on this point is corroborated by Mr. 5 Probasco. 6 Further Genentech presents a different situation than we have before us. In 7 Genentech the inventors conceded a lack of appreciation that the invention worked 8 for its intended purpose and so had to rely upon inurement of the appreciation from 9 a non-inventor. Genentech, Inc. v. Chiron Corp., 220 F.3d at 1353. On the record 10 before us Dr. Bergendahl does not make such a concession. Dr. Bergendahl’s 11 testimony indicates that he appreciated, based on a review of the results from the 12 testing of Mr. Probasco, that successful methods of culturing human ES cells in 13 the presence of H-1152 and Y-27632, had been achieved as of at least 4 May 2007. 14 (Ex. 2059 at ¶¶166 and 167). 15 We deny Sasai Motion 1. 16 3. Bergendahl Motion 3 17 Bergendahl Motion 3 to add a reissue application of the Bergendahl involved 18 patent, i.e., reissue application 14/579,493, filed 11 December 2014, to the 19 interference was deferred. (Bergendahl Motion 3, Paper 90 and Decision, 20 Paper 144 at 15). (“Because we defer Sasai Motion 1, we also defer Bergendahl 21 Responsive Motion 3 which is contingent upon the grant of Sasai Motion 1”). 22 Sasai Motion 1 asserts unpatentability of the Bergendahl claims. Bergendahl 23 Motion 3 is said to be responsive to Sasai Motion 1 in that it is said to address 24 patentability arguments raised in Sasai Motion 1. We deny Sasai Motion 3. 25 35 Accordingly there is no reason for us to add the reissue application to the 1 interference. We deny Bergendahl Motion 3. 2 3 36 IV. Order 1 It is 2 ORDERED that the Bergendahl motion for judgment on the basis of priority 3 of invention is GRANTED; 4 FURTHER ORDERED that the Sasai motion for judgment on the basis of 5 priority of invention is DENIED; 6 FURTHER ORDERED the Bergendahl Miscellaneous Motion seeking the 7 exclusion of Exhibits 1034, 1035, 1036, 1041, 1045, and 1046 is DISMISSED as 8 moot; 9 FURTHER ORDERED that Sasai Motion 1 for judgment on the basis that 10 the Bergendahl claims are unpatentable is DENIED; 11 FURTHER ORDERED that Bergendahl Motion 3 to add reissue application 12 14/579,493 to the interference is DENIED; and 13 FURTHER ORDERED that judgment against Sasai shall be entered in a 14 separate paper. 15 37 cc (via electronic transmission): 1 2 Attorney for Bergendahl: 3 4 Kevin E. Noonan 5 Sarah E. Fendrick 6 Michelle L. McMullen-Tack 7 McDONNELL BOEHNEN HUBERT & BERGHOFF LLP 8 9 noonan@mbhb.com 10 fendrick@mbhb.com 11 mcmullen-tack@mbhb.com 12 13 Attorney for Sasai: 14 15 John Kilyk, Jr. 16 Bruce M. Gagala 17 M. Daniel Hefner 18 LEYDIG VOIT & MAYER LTD. 19 20 jkilyk@leydig.com 21 bgagala@leydig.com 22 dhefner@leydig.com 23 24 25 26 Copy with citationCopy as parenthetical citation