UNIVERSITY OF SOUTH FLORIDA BOARD OF TRUSTEES v. USA

REPLY to Response to Motion re MOTION for Partial Summary Judgment '094 Patent Claims are not Invalid for Prior Inventorship

Fed. Cl.March 15, 2019

THE UNITED STATES COURT OF FEDERAL CLAIMS UNIVERSITY OF SOUTH FLORIDA, BOARD OF TRUSTEES, Plaintiff, v. THE UNITED STATES OF AMERICA, Defendant. ) ) ) ) ) ) ) ) ) ) No. 15-1549 Judge Campbell-Smith USF REPLY TO THE OPPOSITION OF THE UNITED STATES TO USF’S MOTION FOR PARTIAL SUMMARY JUDGMENT – NO PRIOR INVENTORSHIP Determining prior inventorship under pre-AIA 35 U.S.C. §202(g) is often difficult on summary judgment. Complicated fact issues like conception, diligence and corroboration all present questions that may be difficult to resolve in the absence of testimony. Fox Group, Inc. v. Cree, Inc., 700 F.3d 1300 (Fed. Cir. 2012). This is definitely NOT such a case. Summary Judgment on this issue comes down to a single legal requirement – did Borchelt et al have an appreciation of the “accelerated Alzheimer’s Disease related pathology” requirement of the invention claimed in all claims of U.S. Patent No. 5,898,094 (hereinafter “the ‘094 Patent”) before April 25, 1997? That is the day established as the date Karen Duff corroborated the Hardy/Duff actual reduction to practice of the invention of the ‘094 Patent in an electronic message sent to William Coppola – then the individual Case 1:15-cv-01549-PEC Document 137 Filed 03/15/19 Page 1 of 11 2 at University of South Florida’s (hereinafter “USF”) Office of Technology responsible for protecting that invention. Ex. 7 and the record attached thereto. The answer is no – Borchelt and his co-inventors had no idea as of April 25, 1997 that a mouse expressing both a transgene for the Swedish mutation and a presenilin mutation would exhibit accelerated Alzheimer’s Disease related pathology, as this Court construed that key term in its Markman construction of April 17, 2018 (ECF:101). Borchelt himself so testified. Borchelt’s work focused on other issues, because it would take too long to wait for the results showing whether the mice he had exhibited accelerated pathology. Ex. 2, 30:17– 31:19. Borchelt’s work showing deposition of amyloid plaques in the brain of doubly transgenic mice was not submitted for publication until June of 1997, and then revised in August of 1997. Ex. 2, 57:20. The notion of accelerated pathology did not come to Borchelt before June of 1997, because that’s when the data suggesting it was first received by him. Ex. 2, 135:6–14. Borchelt’s group was “turning the data around very, very quickly to get it submitted as fast as possible. As soon as we had it, we were turning around to write it.” Ex. 2, 118:17– 20. Indeed, Dr. Borchelt testified that the first aged doubly transgenic mouse expressing both a presenilin transgene and the Swedish mutation was sacrificed by his group April 9, 1997, Ex, 2, 126:17– 22. The testing, including staining to indicate the presence of amyloid plaques in the brain of this very first mouse was Case 1:15-cv-01549-PEC Document 137 Filed 03/15/19 Page 2 of 11 3 not concluded until June 25, 1997. Ex. 2, 135:6– 14. Respectfully, Borchelt et al had no idea that the double cross mice of the ‘094 Patent would exhibit accelerated pathology before that testing was done in June and July, 1997 – Borchelt so testified. Ex. 2, 140:19–141:3: So, again, we knew that we wanted to age the mice, we did not know how long we would have to age them to see whether something was going to happen. We knew the APP mice by themselves did not develop amyloid pathology until 20 months of age. And we had no idea how much faster it might be – or what the presenilin might do. This Court does not have to determine relative dates of conception – conception requires knowledge of the limitations of the claims, including accelerated Alzheimer’s Disease related pathology. Borchelt et al had no idea the mice they were breeding, the mice expressing both a presenilin transgene and a Swedish mutation transgene, would exhibit accelerated pathology until at least June of 1997, more than a month after Hardy and Duff reduced that very invention to practice. I. POSSESSION OF THE MICE DOES NOT MEAN POSSESSION OF THE INVENTION All of the claims of the’094 Patent expressly call for doubly transgenic mice which exhibit “accelerated Alzheimer’s Disease related pathology” as set forth in Claim 7 – which this Court construed to mean presentation of a feature like amyloid plaques in the brain at least one month earlier in time than the singly transgenic parents or non-transgenic mice would. The first actual reduction to Case 1:15-cv-01549-PEC Document 137 Filed 03/15/19 Page 3 of 11 4 practice demonstrating that effect is by Duff and is dated April 25, 1997. The first actual reduction to practice is the latest possible date of invention. Reese v. Hurst, 661 F.2d 1222 (CCPA 1981), Rey-Bellet v. Englehardt, 493 F.2d 1380, 1382 (CCPA 1974). As of that date, Borchelt et al had not conceived of the invention claimed or reduced it to practice– they had no appreciation that the mice in question would exhibit accelerated pathology. Borchelt’s own prior experience with presenilin mutations led him to conclude the mice he had “had nothing wrong with them.” Ex. 2, 49:6– 16. The Government concedes that to have possession of the invention, to be an inventor, the inventor(s) must appreciate the limitations characterizing the invention. Opp., p. 26. Hitzeman v. Rutter, 243 F. 3d 1345, 1359 (Fed. Cir. 2001), Coleman v. Dines, 754 F. 2d 353,359 (Fed. Cir. 1985). While an inventor need not know with certainty the invention will work to conceive of it, the features of the invention as reflected in the limitation of the claims of the ‘094 Patent must have been perceived for Borchelt et al to have invented those mice. The Government concedes this. Opp., p. 26. Borchelt did NOT know prior to April 25, 1997, or even imagine, the dually transgenic mice he was pursuing would exhibit accelerated Alzheimer’s Disease related pathology. In the absence of that understanding, Borchelt did not make the invention as a matter of law. Indeed twenty (20) years later, Dr. Borchelt testified that at the time (1996–97) – he had Case 1:15-cv-01549-PEC Document 137 Filed 03/15/19 Page 4 of 11 5 no idea what the outcome of introducing the two transgenes might be with regard to accelerated Alzheimer’s Disease pathology.1 The Government goes into detail on the breeding of mice by Borchelt’s group. But the Government concedes that Borchelt’s group did not release the information of accelerated AD pathology in doubly transgenic mice until November, 1997 and did not expect it. Response to SOMF 19, 20, Opp. p. 10. Indeed, testing of the first aged mouse by Borchelt was not complete until after the first actual reduction to practice of the invention of the ‘094 Patent by Duff. It cannot be stressed enough – until Borchelt et al either predicted or observed accelerated Alzheimer’s Disease related pathology, Borchelt lacked conception of the invention. For Borchelt, who testified that no one predicted the acceleration of the pathology that was observed, conception and actual reduction to practice occurred together. This is not unusual in inventions of this type. Hitzeman v. Rutter, supra at 1357 (Fed. Cir. 2001): In this case, however, substantial evidence supports the Board's finding that Hitzeman lacked reasonable certainty that the yeast would produce the particles recited in the counts. Accordingly, the Board was correct in its conclusion that Hitzeman's conception of the invention was simultaneous with his July 20, 1981 reduction to practice. 1 In contrast, Duff testified Hardy and she predicted the presentation of accelerated AD related pathology – which is confirmed by the provisional application filed in October of 1996. On deposition, Duff testified to that effect: Ex. 1, 97:5–8 (“We conceived it. It was the idea that both (mutations) would cause pathology and therefore they’d be multiplicative if you added them together.”) Case 1:15-cv-01549-PEC Document 137 Filed 03/15/19 Page 5 of 11 6 Possession of the mice, when you do not know whether the mice will present accelerated Alzheimer’s Disease pathology, is NOT possession of the invention. A Declaration signed by Dr. Borchelt not even prepared until February, 2019 is submitted by the Government as Ex. 31. The Government’s efforts to pursue further testimony from Dr. Borchelt after his deposition was concluded offers no suggestion, much less evidence, that Dr. Borchelt and his co-workers understood or appreciated the doubly transgenic mice they were breeding would exhibit accelerated Alzheimer’s Disease related pathology . Dr. Borchelt’s sworn acknowledgement that he did not know that the double mutation mice he had bred would exhibit accelerated Alzheimer’s Disease pathology until after the data on the sacrificed mice had been collected and the experiments completed on June 15, 1997 precludes any possibility that Borchelt et al had possession of the invention claimed in the ‘094 Patent by April 25, 1997, as a matter of law. II. BORCHELT IS A COMPROMISED WITNESS To demonstrate prior invention, the law requires proof. The burden of that proof here is on the United States. Prior conception presents the special requirement of corroboration of any evidence provided by an alleged inventor. Price v. Symsek, 988 F.2d 1187, 1195 (Fed. Cir. 1993). Proof of invention by inventors such as Duff and Hardy requires corroboration for conception, like the Application for Grant that matured as Grant AG14633 and the site meeting attended and attested to by Stephen Snyder, the Government’s witness, Ex. 3, Case 1:15-cv-01549-PEC Document 137 Filed 03/15/19 Page 6 of 11 7 77:8– 84:8. Corroboration of an actual reduction to practice, like the communication attached to the Declaration of Coppola, Ex. 7, as well as the testimony of Morgan Ex. 5 and the Declaration of Gordon, Ex. 8, is also required. The requirement for corroboration is to ensure credibility and prevent fraud. Chen v. Bouchard, 347 F.3d 1299, 1309 (Fed.Cir.2003). Thus, an inventor’s testimony requires corroboration. Mahurkar v. C.R. Bard, Inc., 79 F.3d 1572, 1577 (Fed.Cir.1996). The Government offers NO testimony or documents to corroborate Borchelt’s testimony that the Government argues demonstrates a date of invention in advance of April 25, 1997. Indeed, Borchelt himself testified he did not invent the subject matter of the ‘094 Patent until well after the April 25, 1997 actual reduction to practice by Duff. Corroboration for Borchelt’s testimony is of particular importance in this matter because Borchelt himself acknowledged he was compromised by a conflict of interest – he stands to benefit if the ‘094 Patent is found invalid. Ex. 2, 6:9–7:17. There is NO witness that corroborates the story the Government attempts to present that Borchelt and his co-investigators invented the mice exhibiting accelerated Alzheimer’s Disease pathology before Duff and Hardy. That is somewhat surprising, because a number of other investigators were identified in the course of this proceeding, and of course Stephen Snyder and Sangram Sisodia were deposed in this proceeding, but did not offer any testimony corroborating an invention by Borchelt. Where so many individuals that are Case 1:15-cv-01549-PEC Document 137 Filed 03/15/19 Page 7 of 11 8 knowledgeable in the field are identified and some are deposed, and none offers corroboration of an invention by Borchelt et al, it is reasonable to conclude that no such corroboration exists. The Government’s Opposition makes this problem much worse. Rather than rely on the deposition of Borchelt, attended by both parties and reviewed by Borchelt - the Government attempts to introduce the ex parte Declaration of Borchelt, Ex. 31, which asserts, ¶ 11, a conception of “our eventual double transgenic mice,” but nowhere suggests or indicates that conception included the appreciation that the mice would exhibit accelerated Alzheimer’s Disease related pathology. There is nothing addressed in Ex. 31 that was not discussed during Borchelt’s deposition, Ex. 2, no new source of information, no new characterization of the mice as anything but simply doubly transgenic, which we already knew. Instead, the Government attempted to bypass the Summary Judgment process with ex parte inadmissible hearsay that simply skirts the issue. Appreciation of the recitations of the claims of the ‘094 Patent by the Borchelt inventors, and corroboration of that appreciation by someone not the inventors, are both specific requirements of the law concerning prior invention, 35 U.S.C. §102(g). The Government, bearing the burden of proof, satisfies neither. In considering that ex parte testimony one must keep in mind precisely what Dr. Borchelt testified to, given conflicts of interest involving the government. In Ex. 2, 40:4–41:3, Borchelt explained that he had did not provide documents Case 1:15-cv-01549-PEC Document 137 Filed 03/15/19 Page 8 of 11 9 voluntarily to USF, but did in fact produce them voluntarily to the Government. When asked what led him to do that, Borchelt explained: Mr. Brown asked me for some specific notes around specific papers which was – which made it more – which made it a different kind of request than just an open question. And the - NIH pays my bills. So they ask for information, I’m going to give it to them. With respect, this is precisely what the Rule requiring corroboration was designed to address. Dr. Borchelt has a very strong reputation in the field as an eminent researcher, no one questions that. But he does see requests from NIH in a different light than requests from others – a common problem for researchers who are dependent on grants and awards. In this respect, the Rule of corroboration “arose out of a concern that inventors testifying in patent infringement cases would be tempted to remember facts favorable to their case by the lure of protecting their patent or defeating another's patent.” Mahurkar at 1577. No corroboration is offered for David Borchelt’s explanation of his invention. Since Borchelt does not assert, even in his ex parte Declaration, that he made the invention of the ‘094 Patent at any time prior to April 25, 1997, it is unnecessary to test his credibility in this proceeding. But the Government’s decision to walk away from his inter partes examination deposition testimony and rely on an ex parte Declaration is a significant acknowledgement by the Government that Duff and Hardy are in fact the first inventors who conceived the Case 1:15-cv-01549-PEC Document 137 Filed 03/15/19 Page 9 of 11 10 invention as reflected in corroborating documents and testimony, and first actually reduced it to practice, as corroborated by documents and testimony. III. CONCLUSION There is no question of when the invention made by Hardy and Duff was complete – it was conceived no later than September 1, 1995, reflected in the Provisional ‘937 Patent Application filed October, 1996 and actually reduced to practice no later than April 25, 1997. These events have been demonstrated by corroborating testimony of others (Snyder, Morgan, Gordon, Borchelt) and documents (Ex. 7 Coppola Declaration, Ex. 11 ‘937 Application and Ex. 18 NIH Funding Application). Each of these reflect the appreciation that the invention included the accelerated expression of Alzheimer’s Disease related pathology, as recited in the claims of the ‘094 Patent. Borchelt and his co-workers did not appreciate or recognize that the mice they were breeding would exhibit accelerated expression of Alzheimer’s Disease pathology until after their testing of those mice was completed, until at least June of 1997. All we have to demonstrate recognition by Borchelt et al of the exhibition of accelerated Alzheimer’s Disease related pathology is the November, 1997 article in Neuron, Ex. 16, which became available more than six months after the Duff/Hardy reduction to practice. No one, not David Borchelt, not Stephen Snyder, not Sangram Sisodia, no one asserts an earlier date that reflects their appreciation of the accelerated Alzheimer’s Disease related pathology central to the invention of Case 1:15-cv-01549-PEC Document 137 Filed 03/15/19 Page 10 of 11 11 the ‘094 Patent. Failure to appreciate this aspect of the invention prior to Duff and Hardy’s actual reduction to practice of it in April, 1997 is fatal to the Government’s position. No one, at all, corroborates such an invention made by Borchelt et al until the November, 1997 Neuron article. Given that the lead inventor the Government relies on and asserts is first inventor, David Borchelt, is compromised by a conflict of interest he himself recognized, the absence of such corroboration is similarly fatal to the Government’s defense of prior inventorship. USF moves that Partial Summary Judgment that the ‘094 Patent is not invalid for prior inventorship, 35 USC §102(g), be entered. Dated: March 15, 2019 OF COUNSEL: Jerry Stouck Email: stouckj@gtlaw.com GREENBERG & TRAURIG 2101 L Street, N.W., Suite 1000 Washington, DC 20037 (202) 331-3173 phone (202) 261-4751 facsimile s/Steven B. Kelber Steven B. Kelber Email: steve@kelberlawgroup.com THE KELBER LAW GROUP 6701 Democracy Blvd, Suite 300 Bethesda, MD 20817 240-506-6702-Telephone Counsel for Plaintiff University of South Florida, Board of Trustees Case 1:15-cv-01549-PEC Document 137 Filed 03/15/19 Page 11 of 11