Trials@uspto.gov
`571-272-7822
`
`
`
`
`Paper No. 34
`Entered: December 30, 2022
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`______________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`______________
`
`RICETEC, INC.,
`Petitioner,
`
`v.
`
`BASF SE,
`Patent Owner.
`______________
`
`PGR2021-00113 (Patent 11,096,345 B2)
`PGR2021-00114 (Patent 11,096,346 B2)
`______________
`
`Record of Oral Hearing
`Held: December 13, 2022
`______________
`
`
`
`
`Before ULRIKE W. JENKS, TINA E. HULSE, and
`ROBERT A. POLLOCK, Administrative Patent Judges.
`
`
`
`
`
`
`
`
`
`
`
`571-272-7822
`
`
`
`
`Paper No. 34
`Entered: December 30, 2022
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`______________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`______________
`
`RICETEC, INC.,
`Petitioner,
`
`v.
`
`BASF SE,
`Patent Owner.
`______________
`
`PGR2021-00113 (Patent 11,096,345 B2)
`PGR2021-00114 (Patent 11,096,346 B2)
`______________
`
`Record of Oral Hearing
`Held: December 13, 2022
`______________
`
`
`
`
`Before ULRIKE W. JENKS, TINA E. HULSE, and
`ROBERT A. POLLOCK, Administrative Patent Judges.
`
`
`
`
`
`
`
`
`
`
`
`
`PGR2021-00113 (Patent 11,096,345 B2)
`PGR2021-00114 (Patent 11,096,346 B2)
`
`
`
`APPEARANCES:
`
`ON BEHALF OF THE PETITIONER:
`
`
`GERARD NORTON, ESQ.
`RYAN MILLER, ESQ.
`HOWARD S. SUH, ESQ.
`Fox Rothschild, LLP
`Princeton Pike Corporate Center
`997 Lenox Drive
`Lawrenceville, New Jersey 08648
`(609) 896-3600 (Norton)
`gnorton@foxrothschild.com
`rmiller@foxrothschild.com
`hsuh@foxrothschild.com
`
`
`
`ON BEHALF OF THE PATENT OWNER:
`
`
`RICHARD McCORMICK, ESQ.
`YANG-ZI YANG, ESQ.
`LISA FERRI, ESQ.
`Mayer Brown, LLP
`1221 Avenue of the Americas
`New York, New York 10020
`212-506-2382 (McCormick)
`rmccormich@mayerbrown.com
`yyang@mayerbrown.com
`astreff@mayerbrown.com
`
`
`
`
`The above-entitled matter came on for hearing on Tuesday,
`
`December 13, 2022, commencing at 1:00 p.m. EDT, via Video-conference.
`
`
`
`
`2
`
`
`
`PGR2021-00113 (Patent 11,096,345 B2)
`PGR2021-00114 (Patent 11,096,346 B2)
`
`
`P R O C E E D I N G S
`- - - - -
`
`1:00 p.m.
`USHER: Good afternoon. You are here for PGR 2021-00113 and 114
`
`with Judge Hulse, Jenks and Pollock. Our IT person is a man and he will be
`here to assist us with any technical issues that we have.
`
`Please speak loud and clear when it's your turn to speak so that the
`court reporter can hear you. After the hearing is over please stay on the line
`because the court reporter might have questions about spellings. Thank you
`and have a great day.
`
`JUDGE HULSE: Good morning, everyone. I'm Judge Hulse. With
`me online are Judges Jenks and Pollock. Unfortunately, Judge Pollock is
`unable to appear by video today, but we assure you he's there and he can hear
`and he can see you. This a consolidated final hearing in PGR2021-00113
`and PGR2021-00114.
`
`I'd like to start with appearances, please, starting with Petitioner.
`
`MR. NORTON: Yes. Judges Jenks, Hulse and Pollock, this Gerard
`Norton from Fox Rothchild representing the Petitioner RiceTec. And with
`me I have my partners Howard Suh and Ryan Miller.
`
`JUDGE HULSE: Welcome.
`
`And for Patent Owners?
`
`MR. McCORMICK: Yeah, good afternoon, Your Honors. Richard
`McCormick from the Mayer Brown law firm representing Patent Owner
`BASF. I have with me today Lisa Ferri and Yang-zi Yang from my firm as
`well.
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`3
`
`
`
`PGR2021-00113 (Patent 11,096,345 B2)
`PGR2021-00114 (Patent 11,096,346 B2)
`
`JUDGE HULSE: Great, thank you. Welcome everyone. As we stated
`
`in our hearing order, each party will have 60 minutes of time to present their
`arguments. We'll start with Petitioner and then hear Patent Owner's response.
` And then assuming both parties reserve time, we'll hear Petitioner's rebuttal
`and finally Patent Owner's surrebuttal.
`
`Please remember to be explicit when you're referring to any slides on
`the screen so that our transcript is clear. I'll be timing you and we'll give you
`a five-minute and a one-minute warning. Does anyone have any questions?
`
`MR. NORTON: No.
`
`MR. McCORMICK: No thank you.
`
`JUDGE HULSE: All right. Thanks.
`
`MR. SUH: And, Your Honor -- I'm sorry. And, Your Honor, this
`Howard Suh on behalf of Petitioners. I will be arguing, and good morning or
`good afternoon depending on where the judges are. I'd like to start by
`sharing the screen with respect to some slides that we prepared.
`
`JUDGE HULSE: Great. And, Mr. Suh, will you be reserving any
`time?
`MR. SUH: I will. I will be reserving five minutes if that's
`
`appropriate?
`
`JUDGE HULSE: Okay. You may begin.
`
`MR. SUH: Now, can anyone -- can -- I just want to make sure can
`everyone see the slide that's on on the screen?
`
`JUDGE HULSE: Yes, yes.
`
`MR. SUH: Okay, good. So, Your Honors, I just want to put some
`perspective and background with respect to these particular proceedings.
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`4
`
`
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`26
`
`PGR2021-00113 (Patent 11,096,345 B2)
`PGR2021-00114 (Patent 11,096,346 B2)
`
`Last August when Petitioner filed its petitions for cancellation of the
`challenged claims it raised five particular grounds.
`
`Ground one was the lack of written description. Ground two was the
`lack of enablement. Ground three was anticipation based upon prior art,
`which was actually RiceTec's prior published applications the Hinga and the
`Hinga2013 publications. And grounds four and five were to obviousness
`based upon the combination of the Hinga references and other prior art
`references.
`
`Now, Patent Owners' response in these proceedings were that they
`failed to substantively address any of these particular grounds. They had six
`opportunities to do so, including their preliminary response, their surreply to
`their preliminary response. They submitted a declaration by one expert, Dr.
`Burgos. They formally put in their actual response after the Board actually
`instituted these proceedings. And then they submitted another expert's
`declaration replacing Dr. Burgos, and finally they put in another surreply.
`
`And in all those papers they did not substantively address any of the
`particular grounds. Instead, they chose to actually focus only on the grounds
`of standing, namely that the challenged claims are not PGR eligible because
`they are entitled to the filing date of their parent CIP Mankin Line. So
`therefore, based upon that and the way that the issues have been framed in
`these proceedings, there's really essentially a single issue for the PTAB to
`decide, and that is a priority issue.
`
`Are the challenged claims adequately described and enabled by the
`Mankin CIP parent application? And the reason why I emphasize describe
`and enabled is because in order to prove priority Patent Owner has to prove
`both written description and enablement.
`
`5
`
`
`
`PGR2021-00113 (Patent 11,096,345 B2)
`PGR2021-00114 (Patent 11,096,346 B2)
`
`So this the standard for the grounds of standing in order for challenged
`
`claims to become eligible for PGR. Priority has to be shown by proving that
`the earlier applications both have a written description and that there's
`enablement of the challenged claims.
`
`But conversely, when it is Petitioner's burden to actually show that the
`prior applications do not -- are not entitled to an earlier priority date because
`there are two requirements, written description and enablement, the Petitioner
`only has to show that either written description or enablement is not satisfied.
`
`Now, we believe that in our papers that we actually satisfied both
`requirements, but the reason why this becomes important is because Patent
`Owner in all of their papers actually only addressed the written description
`issue.
`So Slide 7, I apologize if I did not explicitly put in the earlier slides'
`
`numbers, but again, this is pictorially showing the grounds of standing with
`respect to the prior parent applications, right? So it was Petitioner's burden
`to show that the challenged claims were not entitled to the filing date of
`something called the Neuteboom PCT line. That's over to the left. And that
`the challenged claims are not entitled to something called the Mankin PCT or
`780 application line. And that's over to the right.
`
`Through the course of the papers Patent Owner has actually dropped
`its priority argument with respect to the Neuteboom line, so it is now only
`relying upon of what we've been calling the Mankin PCT application line.
`
`Now, Slide 8 is a word-for-word recreation of Claim 1 of the '345
`patent. It's a very long claim. I'm not going to be spending time going
`through every single word of the claim, and I do have a slide later in the
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`6
`
`
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`26
`
`PGR2021-00113 (Patent 11,096,345 B2)
`PGR2021-00114 (Patent 11,096,346 B2)
`
`presentation which summarizes the requirements of the slide where some of
`these bold elements have come into play.
`
`But I just want to remind the Board that when we're talking about
`these particular elements, all these elements in order to show an adequate
`written description or enablement, these elements all have to be treated as an
`integrated whole. In other words, you know, Patent Owner cannot just show
`enablement or written description of just one part of the claim, right? It has
`to show that there is written description and enablement support based upon
`everything within the claim working together.
`
`This is Claim 1 of the '346 patent, which is Slide 9, and Slide 10
`actually presents the claim construction issues in the case as they were
`presented by Petitioner and recognized by the institution decision. So there is
`a claim term within the challenged claims called endogenous non-transfected
`mutant, right, and that is describing the actual ACCase's mutation that these
`challenged claims claim causes the rice seed or plant to become herbicide-
`tolerant in the first place.
`
`And that claim construction with respect to endogenous non-
`transfected mutant means that the DNA is endogenous to the respective cells
`of the seed or the plant. It's non-transfected in that it only contains a
`mutation that was randomly produced within the cell.
`
`It is a random mutation. It's not something that can be predicted. It's
`not something that can be introduced through human interventions such as
`recombinant DNA technology. And that was a claim construction that was
`undisputed by the parties.
`
`Now, another claim term that was raised in the petition was effective
`amount. That goes to the idea that these rice plants actually have to be
`
`7
`
`
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`26
`
`PGR2021-00113 (Patent 11,096,345 B2)
`PGR2021-00114 (Patent 11,096,346 B2)
`
`herbicide-tolerant by an effective amount because the whole point of the
`particular alleged invention is that you were going to have herbicide-tolerant
`rice plants, right?
`
`And that effective amount is the amounts of crops herbicides
`specifically listed in the claims such that it actually causes less than 10
`percent injury to the rice plant, right, because in order --
`
`JUDGE HULSE: Counsel?
`
`MR. SUH: Oh.
`
`JUDGE HULSE: I'm sorry to interrupt. Is this a new construction that
`you're proposing because I don't see reference to the 65 percent phytotoxicity
`--
`MR. SUH: Yeah.
`
`JUDGE HULSE: -- as specified in the claims.
`
`MR. SUH: Right. So I'm not arguing the 65 percent phytotoxicity.
`
`I'm arguing that the effective amount actually causes less than 10 percent
`injury to the rice plant, right, and that is not a new construction.
`
`It's actually at the institution decision where it's stated, "We consider
`the less than 10 percent injury together with the effective amounts of
`herbicides to constitute the effective amount limitations." And that's at
`institutional decision at 15 and 18, right?
`
`JUDGE HULSE: Okay. So you're adopting our construction. You're
`not proposing a different construction.
`
`MR. SUH: That is correct. And when I say disputed it is disputed by
`Patent Owner, right, because Patent Owner in their papers are not
`emphasizing the 10 percent injury. They really don't because they're having
`problems actually showing that particular element within the specification.
`
`8
`
`
`
`PGR2021-00113 (Patent 11,096,345 B2)
`PGR2021-00114 (Patent 11,096,346 B2)
`
`Instead, they're relying upon something that you raised, Your Honors,
`
`the 65 percent phytotoxicity.
`
`JUDGE HULSE: So then what is your response that the specification
`expressly defines effective amount and that we shouldn't deviate from that?
`
`MR. SUH: Well, I think the Board should not deviate from it because
`as the Board specifically recognized, those effective amounts are actually
`claimed. They're actually specifically claimed in the challenged claims, right,
`and the Board was correct that in order for the effective amounts to actually
`have any meaning with respect to these claims they have to be at an effective
`amount such that it causes less than 10 percent injury. And that's a claim
`construction and that was actually used by Patent Owners during prosecution.
`
`So, Your Honors, if we go to Slide 11, this was the actual institution
`decision. The Board found that there was no written description support
`from the Mankin PCT Line and it focused upon this effective amount
`limitation.
`
`It also found that there was no written description support from the
`Neuteboom PCT line. It also -- the Board also focused on the effective
`amount limitation, although the Neuteboom PCT issue really has dropped
`away because, as I mentioned before, Patent Owner no longer claims priority
`to the Neuteboom PCT line.
`
`But I wanted to address this next portion, which was at the decision at
`Page 22, right, that the Board said because we find each of the challenged
`claims lacks written description support in any parent applications, right, we
`need not address whether the parent applications also enable the claims to
`determine that the '345 patent is eligible for post grant review.
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`9
`
`
`
`PGR2021-00113 (Patent 11,096,345 B2)
`PGR2021-00114 (Patent 11,096,346 B2)
`
`And that's important again, Your Honor, because, again, in order for
`
`Patent Owner to try to prove an earlier effective filing date they have to
`prove both that the challenged claims are supported by written description
`and enablement. But in order for the Board and for Petitioner to show that
`these challenged claims are PGR-eligible all that needs to be shown is
`whether the challenged claims either lack written description support or lack
`enablement based upon the earlier filed application.
`
`Now, the Board also preliminarily found that it was more likely than
`not that a POSA would be able to actually practice the claimed invention for
`enablement, right? In other words, it found that -- initially found that the
`claims were enabled and initially did find that the challenged claims were
`adequately described.
`
`But it also found on the preliminary record that it is more likely than
`not that the challenged claims are anticipated for obviousness -- or obvious
`over the prior art.
`
`Well, this really comes down to an issue regarding burden of
`production. And Petitioner is not saying that -- is not saying that it doesn't
`have the burden of proving that the claims are unpatentable. That burden
`always belongs to Petitioner.
`
`However, in this particular context when Petitioner actually has
`proven, has shown a prima facie case of anticipation over the filing date,
`right, that there is a burden of production which then shifts to Patent Owner
`to either argue that the prior art does not anticipate the challenged claims,
`right? In other words, that the prior art actually does not meet the limitations
`of the actual claims, or they can argue that the prior art or these references
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`10
`
`
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`26
`
`PGR2021-00113 (Patent 11,096,345 B2)
`PGR2021-00114 (Patent 11,096,346 B2)
`
`are not really prior art because they're entitled to an earlier actual filing date,
`right?
`
`And that proof of trying to argue an earlier effective filing date
`requires both an adequate written description and enablement. So if we look
`at Slide 13, this is how that standard has been applied to this particular case,
`right? The burden of production shifts to Patent Owner because Patent
`Owner -- because Petitioner has provided a prima facie case of anticipation,
`right?
`
`So Patent Owner did not address whether the prior art does or does not
`meet the limitations of the claims, right? Instead, it argued priority, but in
`arguing priority at best it relied upon what we believe was a defective written
`description argument. And it didn't address enablement, and they were
`required to do that. This was their burden of production.
`
`Now, with respect to the issue as to whether the Mankin CIP parent
`line describes the challenged claims, these are some preliminary points, Slide
`14, the challenged claims they issued from a CIP application from the
`Mankin application. New matter was added to the application which resulted
`in the claims. And that's the first point.
`
`And the second point is during prosecution of the challenged claims
`the Patent Office determined at least twice that the application was being
`examined under the first two inventive positions of AIA. In other words, the
`Patent Office determined that the claims were not afforded priority to the
`prior parent applications.
`
`And then, of course, the PTAB in its decisions granting institution
`ruled, obviously, that the challenged claims were PGR-eligible, which is the
`reason why we're here today.
`
`11
`
`
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`26
`
`PGR2021-00113 (Patent 11,096,345 B2)
`PGR2021-00114 (Patent 11,096,346 B2)
`
`So Slide 15, Your Honor, this is our summary of the challenged
`
`claims. All of the challenged claims are to methods of treating rice where the
`rice crop comprises the endogenous non-transfected random G2O96S
`ACCase mutation, what we will be calling the 2096 mutation.
`
`That mutation in the ACCase gene causes the rice crop to be tolerant to
`the various claim FOPS, in other words quizalofop, at the various claimed
`effective amounts, in other words 14 to 140 grams of active ingredient per
`hectare, where that tolerance is measured by the rice crop exhibiting less than
`10 percent injury.
`
`Now, Your Honor, with respect to this particular 2096 ACCase
`mutation it is Petitioner's position that one of the reasons why this particular
`part of the claim, in fact the whole claim itself, is not adequately described is
`that when dealing with this critical ACCase mutation Patent Owners in the
`PCT Mankin CIP Line, all they did was list a whole bunch of different
`potential ACCase mutations which could potentially cause herbicide
`tolerance because this was all the different various hundreds of different
`mutations that were found to be resistant in weeds, which is listed in the prior
`art.
`So this, this is actually just a short portion of the specification. This is
`
`actually a portion of the brief summary of the invention and the 2096
`disclosure is at the very end here, right? And then this a demonstrative but,
`Your Honor, we really -- we hope the Board has an opportunity to truly
`appreciate the repeated listings within the Mankin PCT application when it
`involves the listings of just this 2096 mutation.
`
`It just lists these generic mutations in over 90 paragraphs, 60 pages of -
`-
`
`12
`
`
`
`PGR2021-00113 (Patent 11,096,345 B2)
`PGR2021-00114 (Patent 11,096,346 B2)
`
`JUDGE HULSE: Counsel, --
`
`MR. SUH: -- the mutations.
`
`JUDGE HULSE: -- what about Claim 17 of the PCT application?
`
`Doesn't that expressly claim the G2096S mutation by itself?
`
`MR. SUH: It does, Your Honor. And, Your Honor, if I could just
`skip a little bit ahead, if you don't mind, right, so Claim 17 does specifically
`list the 2096 mutation. But if we look at the other claims as well within the
`original application, Claims 1, 6, 9, 12, 15, they also list particular mutations.
` And these would cover at least 95 mutations.
`
`Claim 18 covers a list of mutations, and that covers at least 190
`mutations. Claim 24 covers at least 323 mutations. Claim 101 covers at least
`418 mutations.
`
`So, Your Honors, just because Patent Owner specifically claimed one
`of these particular mutations within a whole bunch of listings, and it also
`claimed all of them well, we don't think that that provides an adequate
`written description, just in the same way that just because you use the words
`or put the words 2096 within the specification it doesn't mean that that's an
`adequate written description because that is just a laundry list, Your Honor.
`
`And if I could skip ahead to Page 36, Slide 36, right --
`
`JUDGE HULSE: But wouldn't you say though that those claims, like
`you said, in these brackets they cover at least 95 mutations, covers at least
`190 mutations. Claim 17 covers one mutation, right?
`
`MR. SUH: Right. Right. And also, Your Honor, the Claim 1 also
`covered one mutation, right? Claim 6 also covered one mutation. Claim 9
`covered, see what I have in the bracket 1781, 1999, 2027, 2041.
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`13
`
`
`
`PGR2021-00113 (Patent 11,096,345 B2)
`PGR2021-00114 (Patent 11,096,346 B2)
`
`So there are various instances where the claims actually do cover the
`
`other mutations as well, and the claims also do cover more generic type of
`mutations where it covers up to 418 different mutations.
`
`But, Your Honor, if I could just -- this actually goes to the case law.
`Your Honor, even if there is an original claim which actually claims the
`particular 2096 mutation, under the law that still is not an adequate written
`description, right?
`
`So we have case law here, the Enzo case law, right. And here it says,
`"The appearance of mere and indistinct words in the specification or a claim,
`even an original claim, does not necessarily satisfy that requirement," right.
`What you have to show is that the disclosure actually has to show through its
`four corners that one of skill in the art would believe that the inventors
`actually possessed the invention, right?
`
`And again, the Neuteboom case, Federal Circuit 2019, in this
`particular claims the literal words of the claims appear in the specification
`and the original claims.
`
`So I'm sorry I jumped ahead there, Your Honor, but --
`
`JUDGE HULSE: No, that's fine.
`
`MR. SUH: Yeah. But we were here with these particular listings.
`And going now to Slide 18, so with respect to all these different hundreds of
`listings now this is undisputed, right? In the specification it never
`distinguishes this mutation over the other ACCase mutations as to tolerance
`levels against different herbicides.
`
`The spec never shows how the 2096 mutation could be randomly
`mutated or selected over any of the other mutations, right? The spec never
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`14
`
`
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`26
`
`PGR2021-00113 (Patent 11,096,345 B2)
`PGR2021-00114 (Patent 11,096,346 B2)
`
`shows any data regarding the significance of this mutation over the other
`mutations.
`
`And it never explains why this mutation was chosen as a potential
`candidate for herbicide-tolerant rice over other mutations, although later on
`in this proceeding we believe that there -- we believe that the reason why
`eventually claims were issued for the 2096 mutation is because RiceTec
`actually published its Hinga application citing the importance of the 2096.
`But we'll get to that point a little bit later, Your Honors.
`
`So this what Patent Owner's experts -- expert Dr. Somers said when he
`was shown the original claims, when he was shown the repeated generic
`listings of the 2096 mutation, right? He says they're all mentioned. There's
`no question, right?
`
`And then I asked him not only are they mentioned at locations at 20
`and 22 positions but multitudes of mutations at each of the 22 locations,
`right? He says correct.
`
`And then I asked him, "And there's nothing in the PCT application
`which distinguishes the G2096S mutation from any of these other listed
`contemplated mutations, right? Answer, "Ah, well, in the PCT no. No."
`
`Now, when we get to Dr. Shaner, who is Petitioner's expert, what does
`he do when he reviews those multiple listings within the PCT application?
`He said that that does not convey to one of skill in the art that the inventors
`actually possessed rice plants that contain this mutation, this critical mutation
`that actually causes the rice plant to be tolerant at levels that are 10 -- that are
`less than 10 percent injury to the rice, right?
`
`All the applicants did was to scour the prior art for ACCase mutations
`in other plant species like weeds. And as the wish list said that we want to
`
`15
`
`
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`26
`
`PGR2021-00113 (Patent 11,096,345 B2)
`PGR2021-00114 (Patent 11,096,346 B2)
`
`get this all in rice, right? And then they had one experiment with respect to
`the 1781 mutation, not the 2096 mutation, and they showed resistance to
`cycloxydim, which is not in the claimed FOPs. It's in a whole different
`family of herbicides. And even in that experiment the injury to rice far
`exceeded 10 percent.
`
`JUDGE HULSE: Mr. Suh, was the -- were these mutations not known
`in rice?
`
`MR. SUH: They were never shown to be in rice. These mutations
`were only shown to be in weeds, right?
`
`JUDGE HULSE: Thank you.
`
`MR. SUH: So whether these mutations could occur in other plant
`species that was speculations. Of course, all of these positions occur
`naturally in various plant species. The protein even exists in humans, Your
`Honor, the ACCase protein.
`
`So Dr. Shaner he, you know, one of the reasons why he believed that
`there was a lack of possession by the inventors is the fact that the challenged
`claims are inherently unpredictable. And here again we're talking about the
`fact that the claims require that the 2096 mutation occur randomly, not
`through recombinant DNA technology, right. It has to occur randomly in the
`plant tissue. It's not something that could be predicted.
`
`And even Patent Owner's expert, he agreed with the unpredictable
`nature of these random mutations. He stated because there's enough
`sequence polymorphism among the genomes of these different weeds and
`species it's difficult.
`
`It's difficult to know if such a selection mutation would both, one,
`confer the tolerance and also debilitate the enzyme in any way because that's
`
`16
`
`
`
`PGR2021-00113 (Patent 11,096,345 B2)
`PGR2021-00114 (Patent 11,096,346 B2)
`
`a little bit of the unknown, the trick of isolating such a mutant that would
`confer adequate tolerance and not impact plant performance.
`
`Another important point that Dr. Shaner pointed out which was
`unrebutted, unimpeached on the record, is that the inventors did not have an a
`priori approach with respect to these mutations, Your Honor, right? They
`didn't say, you know, we are going to make a 1781 ACCase mutant plant.
`We're going to have -- we are -- or we're going to make a 2096 ACCase
`mutation herbicide-tolerant rice plant. No. No.
`
`What the inventors did is that they subjected the rice tissue to chemical
`mutagens. They relied upon a random somaclonal variation which exists in
`the tissue culture, and then they selected on the rice tissue with different
`herbicides, DIM herbicides and they looked to see which rice tissue actually
`survived.
`
`And then they sequenced it, and then they found out that the surviving
`plants had a particular DNA sequence with a mutation at 1781. It was the
`result of these possessions. It was the result of these particular experiments.
`It was not a preconceived idea.
`
`And then for -- so therefore for Patent Owner to then say, well,
`because we got it at 1781 we can now have a preconceived idea that we can
`get it at all these different mutations. It flies against what was actually done
`in the actual work leading up to these challenged claims, and it flies against
`the actual science behind it.
`
`This is more evidence of what was actually done by the Patent
`Owners. They experimented on thousands and thousands of rice plant lines,
`which each consist of millions of different rice cells.
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`17
`
`
`
`PGR2021-00113 (Patent 11,096,345 B2)
`PGR2021-00114 (Patent 11,096,346 B2)
`
`And in some of those experiments they actually didn't even generate
`
`any mutants from these experiments. They generated one, sometimes up to
`six, but look at the percentage rates. Very low, very unpredictable and none
`of these were to 2096. They're all to 1781 or something called a 2078
`mutation which Patent Owner will be talking about.
`
`But Patent Owner fails to recognize that those 2078 plants were
`stunted and they were they were sterile and they were discarded. They were
`a failure. And this more of what Dr. Shaner was opining with respect to the
`fact that there was not an a priori approach, Slide 24.
`
`And this is another important point that Dr. Shaner concluded upon
`looking at the specification. He said that based upon the CIP Mankin
`specification he saw that the data that they were generating were showing
`that they were selecting the rice tissues on -- based upon DIM herbicides,
`right, tetraloxydim, sethoxydim, cycloxydim.
`
`Figure 2, which is purportedly showing the actual selection process to
`produce these herbicide-tolerant rice plants, Figure 2, Paragraph 64, only
`shows that cycloxydim was being used for the stepwise selection processes.
`
`Now, there are other parts of the CIP parent application where it
`mentions haloxyfop. But conveniently, or at both times haloxyfop is actually
`mentioned, the data is not shown. Paragraph 270 says "or haloxyfop not
`shown," right?
`
`Further on it talks about selection processes, haloxyfop data not
`shown. And when they do show the data, Paragraph 294, what are they --
`what do they show? The selection herbicide was cycloxydim and
`sethoxydim not haloxyfop, not a FOP.
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`18
`
`
`
`PGR2021-00113 (Patent 11,096,345 B2)
`PGR2021-00114 (Patent 11,096,346 B2)
`
`So Dr. Shaner, his only reasonable conclusion is that haloxyfop was
`
`not used to select any of these mutant rice plants. And as a result, as of the
`time of the Mankin CIP parent, it was known that DIMs could not select for
`an ACCase mutation as a 2096 mutation. It just could not because DIM
`herbicides would actually kill a plant with a mutation at 2096 a.
`
`And how do we know that? The Patent Office recognized this, right?
`In a related application it said, "It is well-known at the time of the filing that
`a G2096S substitution conferred little or no tolerance to DIMs herbicides.”
`
`Even Patent Owner's expert admitted to this. He said, "That in rice
`tissue cultures under this selection system I don't think a POSA -- well, I
`think it gives you a guideline to predict how much work you have to do, but I
`don't think a POSA would attempt at their first attempt to use a DIM for
`selection of 2096."
`
`So the Mankin CIP parent actually teaches away from making a 2096
`herbicide-tolerant plant. The only evidence that Patent Owner used to try to
`rebut this idea that DIMs could actually be used to select for the 2096
`mutation is Neuteboom, but we know that Patent Owners had actually
`dropped their reliance on Neuteboom as priority.
`
`And we also know that the Neuteboom disclosure that Patent Owners
`rely upon has nothing to do with the challenged claims, right? If you look at
`the part that's reproduced on this Slide 28, right?
`
`Neuteboom had to deal with a method to detect mutations in yeast, not
`in rice. It involved herbicides which were not the claimed FOPs. They'd use
`application rates at the micromolar level in a laboratory, not the 14 to 140
`grams of active ingredient in the natural field.
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`19
`
`
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
Accessing this document will incur an additional charge of $.
After purchase, you can access this document again without charge.
Accept $ Charge
Still Working On It
This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.
Give it another minute or two to complete, and then try the refresh button.
A few More Minutes ... Still Working
It can take up to 5 minutes for us to download a document if the court servers are running slowly.
Thank you for your continued patience.
This document could not be displayed.
We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.
Your account does not support viewing this document.
You need a Paid Account to view this document. Click here to change your account type.
Your account does not support viewing this document.
Set your membership
status to view this document.
With a Docket Alarm membership, you'll
get a whole lot more, including:
- Up-to-date information for this case.
- Email alerts whenever there is an update.
- Full text search for other cases.
- Get email alerts whenever a new case matches your search.
One Moment Please
The filing “” is large (MB) and is being downloaded.
Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.
Your document is on its way!
If you do not receive the document in five minutes, contact support at support@docketalarm.com.
Sealed Document
We are unable to display this document, it may be under a court ordered seal.
If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.
Access Government Site
