PGR 2019-00032 Paper 37
`Patent 9,976,125 B2 Entered: July 16, 2020
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`RECORD OF ORAL HEARING
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`U.S. PATENT AND TRADEMARK OFFICE
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`LIFESCAN GLOBAL CORPORATION,
`Petitioner,
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`v.
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`IKEDA FOOD RESEARCH, LTD.,
`and PHC CORPORATION,
`Patent Owner.
`____________
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`PGR 2019-00032
`Patent 9,976,125 B2
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`Oral Hearing Held: June 18, 2020
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`Before DAVID COTTA, ROBERT A. POLLOCK and ERICA A.
`FRANKLIN, Administrative Patent Judges.
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`APPEARANCES:
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`ON BEHALF OF THE PETITIONER:
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`AARON S. ECKENTHAL, ESQUIRE
`Lerner David Littenberg Krumholz & Mentlik
`20 Commerce Drive
`Cranford, NJ 07016
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`PGR 2019-00032
`Patent 9,976,125 B2
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`ON BEHALF OF THE PATENT OWNER:
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`KENNETH P. GEORGE, ESQUIRE
`Amster Rothstein and Ebenstein
`90 Park Avenue, 21st Floor
`New York, NY 10016
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`The above-entitled matter came on for hearing on Thursday, June 18,
`2020, commencing at 1:00 p.m. EDT, by video/by telephone.
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`PGR 2019-00032 Paper 37
`Patent 9,976,125 B2 Entered: July 16, 2020
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`P R O C E E D I N G S
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`JUDGE COTTA: So, do we have everyone on the line who's
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`supposed to be on the line?
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`MR. GEORGE: This is Kenneth George representing the patent
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`owners. I'm on the line.
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`MR. ECKENTHAL: Hi, this is Aaron Eckenthal representing
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`petitioner.
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`JUDGE COTTA: Okay, thank you. Okay, let's get started then.
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`Good afternoon, this the final hearing in PGR2019-00032, regarding
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`Substitute Claim 11 of U.S. Patent Number 9,976,125. The petitioner is
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`Lifescan Global Corporation. The patent owners are Ikeda Food Research
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`Company, Limited and PHC Corporation. The hearing is open to the public
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`and a full transcript of the hearing will be made of record. I'm Judge Cotta
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`and with me are Judges Pollock and Franklin.
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`Counsel for the petitioner, would you please identify yourself for the
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`record?
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`MR. ECKENTHAL: Yes, good afternoon, Your Honors. My name is
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`Aaron Eckenthal from the law firm of Lerner David representing Lifescan
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`Global Corporation.
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`JUDGE COTTA: Thank you. And counsel for the patent owner,
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`could you kindly identify yourself for the record as well?
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`MR. GEORGE: Yes, Kenneth George with Amster Rothstein and
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`Ebenstein, counsel for the patent owners.
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`JUDGE COTTA: Okay. So, as set forth in our hearing order of May
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`12, 2020, each side has 45 minutes to present its case. My colleagues and I
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`will do our best to keep track of time, but we suggest that the parties do the
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`same.
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`Counsel for the petitioner, would you like to reserve any time for
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`rebuttal?
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`MR. ECKENTHAL: Yes, I would, Your Honor. I'd like to reserve 15
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`minutes for rebuttal.
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`JUDGE COTTA: Okay. And counsel for patent owner, you may
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`have the last word today if you'd like it. Would you like to reserve any
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`time?
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`MR. GEORGE: Yes, 10 minutes, thank you.
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`JUDGE COTTA: Okay. Before we begin, there are a few things I'd
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`like to cover. First, on behalf of the board, I'd like to thank everyone for
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`their flexibility in participating in this all video hearing. Given that this is a
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`departure from our typical practice, I'd like to emphasize that our primary
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`concern is your right to be heard. So, if at any point during the proceeding
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`you encounter technical difficulties or other difficulties that you feel
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`undermine your ability to represent your client adequately, please let us
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`know.
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`Second, if you're not speaking, please mute your microphone so we
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`have a clearer connection. Third, and please try to identify yourself each
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`time you speak. We will do the same for the benefit of the record. Fourth,
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`we have access to the entire record, including demonstratives. So, when you
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`refer to each demonstrative, paper, or exhibit, please do so by slide or page
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`number and allow us a few seconds to find it. Finally, if you come to a good
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`PGR 2019-00032
`Patent 9,976,125 B2
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`faith belief that the pace of this proceeding prevents you from adequately
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`explaining your position, please speak up and we'll consider extending the
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`allotted time.
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`Petitioner will go first as it bears the burden of showing
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`unpatentability of the challenged claims. So, petitioner, you can begin
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`whenever you are ready.
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`MR. ECKENTHAL: Thank you, Your Honor. Good afternoon. As
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`we heard before, my name is Aaron Eckenthal and I am from the law firm of
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`Lerner David representing the petitioner in this case, Lifescan Global
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`Corporation. And as Your Honor just stated, it seems that you have access
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`to the demonstratives so, I'm going to refer to those throughout today's
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`presentation.
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`I'd like to start with slide number 2. Just to touch on the 125 patent
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`briefly here in the fact that it relates to an FAD-conjugated glucose
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`dehydrogenase, which is a specific enzyme that's used in a biosensor and its
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`ability is to detect glucose. And through patent owner's amendments here, I
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`think the overall issue is really quite narrow. And Your Honors seem to
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`have really zeroed-in on this precise dispute between the parties at this point
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`as having to do with the particular FAD-conjugated GDH enzyme. Which in
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`this case at issue is Aspergillus oryzae NBRC 30104.
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`And I will address the points that the board sought to be addressed
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`earlier this week in their email. But I just want to give some context to
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`patent owner's amendments. And the amendments made to Substitute Claim
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`11, which is really original Claim 8 that's been rewritten into independent
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`form, focuses on two particular aspects in addition that have been amended
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`from the original claim.
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`Patent 9,976,125 B2
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`One is the polypeptide sequence. And the second has to do with the
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`enzymatic activity from maltose. And then in patent owner's Revised
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`Motion to Amend, which is seen here on slide 2, they further narrowed the
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`polypeptide sequence to one form in particular, which is a strain --
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`polypeptide from a particular strain of aspergillus oryzae. In this case,
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`again, 30104, but they kept the same amendment with respect to the maltose
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`limitation of 5 percent or less.
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`So, if we turn to slide 3 here, we can now look at patent owner's
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`proposed amendment to Claim 11 in a little more detail. And in particular,
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`the polypeptide because that's really where this dispute lies. So, patent
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`owner started off with a polypeptide sequence, SEQ ID NO:1 in this
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`particular case, and also, those that are 90 percent or more homologous.
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`And with each amendment they went through, they narrowed the sequence,
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`recognizing first the unpatentable nature of SEQ ID NO:1. And then patent
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`owner's amendment to deal with the homologues of it. And then the current
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`presented claim in its Revised Motion to Amend, which limits the sequence
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`to a particular FAD-conjugated GDH from Aspergillus oryzae 30104.
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`And what's important to note about this amendment here is that you
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`see this yellow highlighting on the slide. And pretty much everything after
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`this slide on this top part here is -- does not really serve to limit the claim
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`any further. You have a sequence that's recited that is really the structure of
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`the FAD-conjugated GDH that's present. And you have the functionality of
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`it that the FAD-conjugated GDH at the bottom part of this claim here has
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`glucose dehydrogenase activity. And all of that is just a mere result of
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`having the FAD-conjugated GDH from this particular strain.
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`Patent 9,976,125 B2
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`But even if these are considered limitations somehow, which patent
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`owner -- petitioner does not believe they are limiting at all, a POSA would
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`have knowledge to know that these aspects are present just based on its
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`general knowledge. And we've also -- petitioner here has also presented
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`evidence from its expert, Dr. LaBelle, that such properties here, after this
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`yellow highlighting, are either inherent from the particular species, or that
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`the POSA would know how to obtain that particular sequence from the
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`particular species and strain.
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`So, to summarize patent owner's Substitute Claim 11, and just to turn
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`back to slide 2 for a brief moment here, it really is three different aspects.
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`The first is a biosensor comprising a recombinant FAD GDH. And the
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`second part is the recombinant FAD GDH from having a polypeptide from
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`Aspergillus oryzae NBRC 30104. And then the final part, which was from
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`original Claim 8, is the pH aspect at the very bottom of this claim where the
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`biosensor is capable of detecting glucose by a pH change.
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`The remainder of these amendments that you see here in the claim
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`really just serve to make it appear that patent owner is claiming much more
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`than it really is. And although the patent owner in this case want the focus
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`on aspects after what we saw in the yellow highlighting on slide 3, those
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`aspects don't serve to limit the claim. So, we would submit to you that such
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`a focus would be misplaced. So, in that context, the obviousness inquiry
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`here really focuses on what was known by a POSA about the sources of
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`FAD-conjugated GDH, and also, what was known by a POSA about the
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`functional equivalents of FAD-conjugated GDH.
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`So, if we turn to slide 5 here, we can begin with what a POSA knew
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`about sources of FAD-conjugated GDH from some of the prior art that's of
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`Patent 9,976,125 B2
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`record here. And although Aspergillus oryzae was first appreciated in the
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`1800s, it was recognized that there were multiple strains in the early 1900s
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`and in the 1950s and '60s, it was appreciated that it possessed this enzyme
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`for glucose sensing. And the art of record, first Ogura in the 1950s,
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`followed by Bak in the 1960s, appreciated the glucose reactivity of
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`conjugated GDH derived from Aspergillus oryzae. And that that specific
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`enzyme can be used in biosensors to detect glucose.
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`And then we move on to Senior, which is also of record in this
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`proceeding. And Senior appreciated the use of FAD-conjugated GDH
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`enzyme in a biosensor and that Aspergillus oryzae -- sorry, Aspergillus, in
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`general, as a genus, is a source for that particular enzyme. So, Senior
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`discloses that FAD-conjugated GDH is not just in the oryzae species. And
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`this is also confirmed by Omura, which is also of record here. And Omura
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`somewhat ties together Bak and Senior in this respect. And demonstrates
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`that the FAD-conjugated GDH in Aspergillus, you see it at the genus level.
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`Because in Omura, it's noted that this particular enzyme is present in two
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`different species of Aspergillus, the species of terreus and oryzae.
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`So, what does this mean for a POSA? Well, it means that a POSA
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`would have appreciated that there is a large degree of conservation among
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`Aspergillus. And if FAD-conjugated GDH is conserved at the genus level,
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`as recognized by Senior and by Omura, it's most likely conserved at the
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`species level and at the strain level. So, when you look at the specific strain
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`in this case, which is Aspergillus oryzae NBRC 30104, this is one of the
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`oldest and well known strains of Aspergillus.
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`So, if you turn to slide 6, slide 6 here, you know, it shows that NBRC
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`30104 was known since 1876. When it was first isolated, it was called RIB
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`Patent 9,976,125 B2
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`430. Again, someone else thought they had isolated a unique strain in 1976.
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`They called it NBRC 30104. Certain databases categorize all these strains
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`and the NITE database recognized that 30104 and the RIB 430 strains are,
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`indeed, one and the same.
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`JUDGE COTTA: Counsel, do you have --
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`MR. ECKENTHAL: So, --
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`JUDGE COTTA: If I can interrupt for a second? Do you have any
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`evidence that --
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`MR. ECKENTHAL: Sure.
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`JUDGE COTTA: -- it would have been obvious to select any
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`particular strain of Aspergillus oryzae? Or are you relying primarily on the
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`substitution of equivalents?
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`MR. ECKENTHAL: We are relying on the substitution that it is an
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`equivalent functionality for any Aspergillus oryzae, for any FAD-conjugated
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`GDH, from any Aspergillus oryzae. I mean, when you start looking at the
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`evidence as we're going to see. I'm going to continue going through that.
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`You know, it becomes pretty apparent to a POSA that these particular
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`enzymes are present in Aspergillus across the board. And it would be
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`obvious to simply substitute one for the other. There's no distinction on this
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`record as to differences in functionality between any of these FAD-
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`conjugated GDHs. And in fact, --
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`JUDGE COTTA: So, can I --
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`MR. ECKENTHAL: Sure.
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`JUDGE COTTA: Can I interrupt you again? So, Table 1 of the 125
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`patent has -- identifies a number of different strains of Aspergillus oryzae
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`and --
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`Patent 9,976,125 B2
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`MR. ECKENTHAL: Mm-hmm.
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`JUDGE COTTA: -- indicates that FAD-conjugated glucose
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`dehydrogenase has activity in some of them, but not in others. How do you
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`reconcile that with your substitution of equivalents argument?
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`MR. ECKENTHAL: So, I think we've reconciled that. And the
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`testimony of our expert, Dr. LaBelle, speaks more clearly to this in his
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`declaration in Exhibit 1031 in that there are some -- well, that table is
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`speaking toward activity level versus functionality. And just because a
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`FAD-conjugated GDH -- Your Honors, are you still with me here? Because
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`I seem to have to lost video. I just want to confirm that you can still hear
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`sorry.
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`JUDGE COTTA: I can still hear you and I can still see you.
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`MR. ECKENTHAL: Okay. There you go. Now you're back. So, --
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`Table 1 just because there's an active FAD-conjugated GDH, that's
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`different from functionality. And in that table, what we're seeing is whether
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`or not an FAD-conjugated GDH is active. And for activity, there are a host
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`of other aspects that play into whether a gene, and in this case, the FAD-
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`conjugated GDH, becomes active. Such as the conditions that the organism
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`was grown in, or in this case, the specific strain was grown in. So, light
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`could impact that. Different nutrients in which it was grown in may impact
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`whether or not a FAD-conjugated GDH is active. Table 1 and the one -- and
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`this particular patent do not examine the functionality of it. And in fact,
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`when you start looking at whether or not there's a functional versus -- or,
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`sorry, an active FAD-conjugated GDH in Table 1, versus an inactive one,
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`nothing there deals with functionality.
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`Patent owner, in fact, doesn't deal with the functionality of them and
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`deals with them all one and the same. And that's actually shown through the
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`course of the amendments that have been presented in this particular case.
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`Where patent owner first started with SEQ ID NO:1 and then went to -- with
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`90 percent homology to that sequence, through the amendments have
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`admitted that Claim 1 -- sorry, SEQ ID NO:1 is unpatentable. And has then
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`tried to go after just the homologues of SEQ ID NO:1 to where we now have
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`a claim reciting a specific Aspergillus oryzae strain and -- or the FAD-
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`conjugated GDH from that -- from a particular strain.
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`So, the claim has gotten narrower and narrower. And what they've
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`tried to do here is initially tried to capture all the homology to SEQ ID
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`NO:1, which in this case, is really all functional equivalents. And when you
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`start looking at these things, you know, they all -- just because they have the
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`different amino acid sequences, it might be different at the amino acid
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`sequence level as shown in example 6 in the patent. And then, you know,
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`that dovetails into Table 1. What you will see is that these small variations
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`in amino acid sequences don't have any impact on the functionality.
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`So, when you're looking at the overall functionality of it, you don't
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`even need to get to the amino acid sequence. You know, it's simply all of
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`these are functional equivalents of one another. There is no unexpected
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`result that is discussed in the patent disclosure. And in fact, there is no
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`unexpected result here. When you start switching out one FAD-conjugated
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`GDH in place of another, as long as it's active and functional, you would be
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`-- you know, you would expect to achieve what you have here, which is a
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`biosensor with the NBRC 30104 strain, or any other strain, you know, for
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`that matter.
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`Does that answer your question, Your Honor?
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`JUDGE COTTA: I think so. Is it your contention that the person of
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`skill in the art would just know not to use a strain that's shown to be
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`inactive?
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`MR. ECKENTHAL: Well, Your Honor, I mean, I don't know that a
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`POSA would know not to use a strain that's inactive. I mean, I think a
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`POSA would have a reasonable belief overall that a -- that FAD-conjugated
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`GDH is present in Aspergillus oryzae regardless of the strain, okay? I think
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`once they start investigating them, you know, you can see whether one is
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`active, whether one is not active. And, of course, again, activity depends
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`upon how it was grown. So, just because Table 1 shows that some of them
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`are inactive, it might be that those are inactive just strictly based on how
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`those were grown and cultured in this particular instance, right? So, if you
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`grow them and culture that particular strain, under different conditions,
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`perhaps it leads to a functional or in this case, active and functional GDH.
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`And I think one of the --
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`JUDGE POLLOCK: This is Judge Pollock. Can I jump in --
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`MR. ECKENTHAL: Sure.
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`JUDGE POLLOCK: -- just for a second? Just to clarify, --
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`MR. ECKENTHAL: Sure.
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`JUDGE POLLOCK: -- it was known in the art that NRBC 30104 did
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`have FAD-conjugated glucose dehydrogenase activity, correct?
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`MR. ECKENTHAL: It was known generally that Aspergillus oryzae
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`has FAD-conjugated GDH, okay? And that was known -- it was shown
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`across the board that -- and I think a POSA would recognize this, that it's
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`very fairly conserved amongst Aspergillus at the genus level. And that's
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`PGR 2019-00032
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`demonstrated by Omura, okay? So, if it's conserved at the genus level and
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`when you drill down at the species level, as shown by Omura, when you
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`have Aspergillus terreus and Aspergillus oryzae, I believe both of those
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`show that it is a strong likelihood that a POSA would have a reasonable
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`belief that all Aspergillus oryzae, including 30104, have the FAD-
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`conjugated GDH.
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`JUDGE POLLOCK: But the art of record does not expressly call out
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`NBRC as having this activity?
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`MR. ECKENTHAL: That is correct. It doesn't call out for it
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`specifically having this reactivity. But, again, I think that it's strongly -- a
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`POSA would recognize that it is most likely that it would have it, as all of
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`the other strain -- or other strains of Aspergillus oryzae of record show that it
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`does have it. And I think from there, a POSA would recognize given the
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`conservative aspect of it and the functionality that's been demonstrated
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`across the board from these other references, Ogura, Bak, Senior, and
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`Omura, and even Tsuji, for that matter, that you could take any one of these
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`strains from Aspergillus oryzae so there is a reasonable likelihood that this
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`particular gene is in there. And you could then use that based on the known
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`functionality of it, because these are all functional equivalents. There's
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`nothing in the art that says that these are not functional equivalents and
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`there's nothing unexpected about using this particular Aspergillus oryzae
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`30104, and use it in a biosensor as recited in patent owner's Substitute Claim
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`11.
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`JUDGE POLLOCK: Thank you very much for clarifying that.
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`MR. ECKENTHAL: Okay. So, I think from -- so, what I'd like to do
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`is I want to get back to this. And I want to turn to what a POSA would have
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`PGR 2019-00032
`Patent 9,976,125 B2
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`known about the functionality aspect of the FAD-conjugated GDH enzymes.
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`And I think I may have touched on some of this. But I just want to, again,
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`be clear about this. You know, when we look at Omura, there is a clear
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`suggestion to a POSA that the GDH from Aspergillus oryzae and
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`Aspergillus oryzae is functionally the same. You know, again, this is --
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`well, Omura describes this functionality that it's different only with respect
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`to the stability of these different enzymes has nothing to do with the
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`functionality of the actual glucose dehydrogenase activity. So, again, this is
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`also consistent with and further demonstrates Senior's recognition that
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`Aspergillus at the genus level is a source of FAD-conjugated GDH enzyme.
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`So, again, none of these references of record, and there is nothing on
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`this record, that makes any distinction as to functionality of FAD-conjugated
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`GDH across the genus, the species, or the strains. So, if you take those
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`teachings collectively, a person of ordinary skill would recognize the high
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`probability that FAD-conjugated GDH would be functionally the same
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`across Aspergillus oryzae strains. And even if a species' specific FAD-
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`conjugated GDH deferred at the genomic level, those differences are likely
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`undetectable if the functionality is the same. So, in other words, a POSA
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`would have little reason to examine the FAD-conjugated enzyme at the
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`sequence level given the same functionality of it.
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`And, again, you know, with Table 1, I think, you know, the patent
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`owner's specification in the 125 patent enforces this exact point. And, I
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`mean, I don't have a slide that shows Table 1 exactly, but I presume that the
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`board does have the exhibits, Exhibit 1005.
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`JUDGE COTTA: We do.
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`Patent 9,976,125 B2
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`MR. ECKENTHAL: And, you know, this again is demonstrating an
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`active versus an inactive FAD-conjugated GDH. And, you know, none of
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`these active FAD-conjugated GDH enzymes are described as having any
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`different functionality from one another. Each of these strains in Table 1 are
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`compared to the NBRC 5375 strain, which in the patent it's SEQ ID NO:1.
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`And they're all compared to this simply in passing at the amino acid level --
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`amino acid sequence level. And, in fact, when NBRC 30104 is compared,
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`it's shown to be identical with only two amino acid differences that does not
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`appear to impact functionality. And, again, if you're just looking at it from a
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`functionality perspective, you wouldn't even get to the amino acid sequence
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`level.
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`But if you look, again, at how patent owner amended Claim 11, right,
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`first it's trying to capture SEQ ID NO:1 and a certain level homology. Then
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`just the level of homology, and now the specific sequence that's been -- this
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`particular sequence isn't even formally recited in the sequence listings in this
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`patent. It really just goes to show that they were really after SEQ ID NO:1
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`and known functional equivalents, such as NBRC 30104 strain. But even
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`though, again, they may be functional equivalents, they could still be
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`different at the amino acid sequence level.
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`So, turning to slide 9 right now, at the bottom, you know, I really want
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`to say what the takeaway from all this is to a POSA. And, again, that's --
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`there's nothing special about the functionality of FAD-conjugated GDH
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`from NBRC 30104 strain as compared to FAD-conjugated GDH from any
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`other Aspergillus oryzae strain. There's nothing of record that indicates that.
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`So, if a POSA understood that FAD-conjugated GDH is present in
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`Aspergillus, and in particular, Aspergillus oryzae, and also understood that
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`PGR 2019-00032
`Patent 9,976,125 B2
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`there is no functional difference among them. We can turn to slide 10, and
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`we see that a POSA would recognize that it could utilize any FAD-
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`conjugated GDH from Aspergillus oryzae in the biosensor that's recited in
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`patent owner's Substitute Claim 11. What's being done here is really nothing
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`more than a substitute of one known element for another. And in this case,
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`it's one known FAD-conjugated GDH for another GDH. And when you do
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`that, a POSA would certainly expect success in achieving the bio -- a
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`biosensor with an FAD-conjugated GDH from NBRC 30104.
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`So, now I want to turn to -- switch gears a little bit here, and I want to
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`talk about patent owner's notion --
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`JUDGE COTTA: Just to give you a --
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`MR. ECKENTHAL: Sure.
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`JUDGE COTTA: Just to give you a heads up while you switch gears,
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`you have about five minutes left.
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`MR. ECKENTHAL: Okay. So, I just want to touch on patent
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`owner's notion that a POSA could not make a recombinant GDH. And this
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`is really a new argument that patent owner kind of brought up in its reply
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`brief here. It is a limitation that's been present from the outset. But
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`nevertheless, patent owner's argument that relies on the recombinant
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`limitations fails because it appears to rest squarely on whether an FAD-
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`conjugated GDH sequence from Aspergillus oryzae was known or whether a
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`person could obtain those sequences.
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`And, you know, going through the record here, I think it becomes
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`clear that a POSA could go about and obtain an FAD-conjugated GDH gene
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`from the -- from Aspergillus oryzae here. We have in slide 11, we have the
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`definition of a POSA, which includes how to create a recombinant, you
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`Patent 9,976,125 B2
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`know, because it's a -- well, the patent owner and the petitioner here are
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`generally in agreement that this is the definition. And a POSA includes
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`recombination -- or knowledge of recombinant DNA techniques. So, this
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`not only includes how to create a recombinant, but also sequencing. So, the
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`evidence of record here demonstrates that a POSA knows how to create a
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`recombinant.
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`Now, I just want to turn to -- I want to turn to the overall argument
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`here as to the obviousness. I mean, now that we have this background with
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`the sequences that have been set forth and the functionality and that, you
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`know, what a POSA would know. Actually, before I do that, I just want to
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`touch on Tsuji real quick in that, you know, our expert, Dr. LaBelle,
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`explained that it is within the purview of a POSA to determine the sequence
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`of Aspergillus oryzae. And I know that patent owner seems to make a big
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`deal about this that it was -- that Tsuji is actually some teaching away and
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`that it's very difficult to obtain a sequence. But the problem with that
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`argument is first, that they deem that conventional techniques in Tsuji, are
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`really much broader than what patent owner alleges. In fact, that Tsuji used
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`alternative conventional techniques to obtain the sequence there. And such
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`alternative methods might be considered difficult and they might even be
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`unconventional, but that does not mean that they're not within the purview of
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`a POSA.
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`And second, Tsuji did what a POSA would do when one conventional
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`technique did not work. They used alternative techniques to get to the
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`sequence. And finally, Tsuji, who patent owner deems to be a POSA, was
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`able to obtain the sequence and Tsuji is prior art. So, it tells other people
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`how to obtain the sequence.
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`So, given that background, if we turn to slide 16, Omura in
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`combination with the knowledge of a POSA will render patent owner's
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`proposed Substitute Claim 11 obvious. As we saw before, Omura teaches
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`the elements of -- as we can see here, that it will teach the elements of the --
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`with the exception of the NBRC 30104 strain, which again, is simply
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`replacing a functionally known equivalent. So, if you look at slide 16 here,
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`Omura teaches a biosensor containing recombinant FAD-conjugated GDH.
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`If we turn to slide 17, as we already discussed, Omura teaches the genus of
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`Aspergillus was a known source of FAD-conjugated GDH. And, likewise,
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`Senior also teaches a POSA that sources of FAD-conjugated GDH are from
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`Aspergillus.
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`If we switch over to slide 19, Omura teaches that a biosensor uses pH
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`as detection. And then again, moving to slide 20, a POSA here would be
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`motivated to utilize the FAD-conjugated GDH from NBRC 30104 in place
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`of the FAD-conjugated GDH from Terreus that's used in Omura based on
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`the similarities and characteristics of the enzyme. And this point is
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`unrebutted by patent owners throughout the proceeding. And a POSA
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`would also be motivated to use Omura and to swap out Aspergillus oryzae
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`by the desire to industrially produce coenzyme binding GDH in a
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`commercial expression. And considering this is merely a substitute of one
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`functional FAD-conjugated GDH for another as interchangeable, a POSA
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`here, again, would expect to achieve success.
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`I know I'm kind of going over my half an hour here a little bit, but I
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`just want to touch very briefly on Tsuji real quick. I know that's going to cut
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`into my time, right? But that's okay.
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`Patent 9,976,125 B2
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`JUDGE COTTA: Yeah, you are over your time. If you want to be
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`real quick, go ahead.
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`MR. ECKENTHAL: Yeah, real quick. I just want to touch on Tsuji
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`real quick. And to save time, I'm just going to touch on the aspects of Tsuji
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`here since Omura applies in the same or similar way that we just discussed.
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`And turning to slide 21, Tsuji teaches a biosensor containing
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`recombinant FAD-conjugated GDH from Aspergillus oryzae. Again, slide
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`22, Tsuji teaches a POSA how to go about obtaining the sequence from an
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`FAD-conjugated GDH from Aspergillus oryzae. And that's regardless of the
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`strain. So, when we get to slide 25 here, you know, when you combine Tsuji
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`with Omura in view of one skilled in the art, what was known about
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`Aspergillus oryzae, the presence of FAD-conjugated GDH, you know, a
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`POSA was aware that it was present in Aspergillus oryzae. They would
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`recognize the conservative nature of it in Aspergillus. And, again, Claim 11
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`merely exchanges FAD-conjugated GDH from one strain for a known
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`equivalent from another.
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`The functionality of these is indistinguishable. So, for all of