Paper No. 39
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`UNITED STATES PATENT AND TRADEMARK OFFICE
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`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`___________
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`COMMONWEALTH SCIENTIFIC INDUSTRIAL AND
`RESEARCH ORGANISATION,
`Petitioner,
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`v.
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`BASF PLANT SCIENCE GMBH,
`Patent Owner.
`___________
`
`PGR2020-00033
`Patent 10,301,638 B2
`___________
`
`Record of Oral Hearing
`Held: June 14, 2021
`_____________
`
`Trials@uspto.gov
`571-272-7822
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`Before ULRIKE W. JENKS, JO-ANNE M. KOKOSKI, and
`JEFFREY W. ABRAHAM, Administrative Patent Judges.
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`UNITED STATES PATENT AND TRADEMARK OFFICE
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`___________
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`
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`COMMONWEALTH SCIENTIFIC INDUSTRIAL AND
`RESEARCH ORGANISATION,
`Petitioner,
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`v.
`
`BASF PLANT SCIENCE GMBH,
`Patent Owner.
`___________
`
`PGR2020-00033
`Patent 10,301,638 B2
`___________
`
`Record of Oral Hearing
`Held: June 14, 2021
`_____________
`
`Trials@uspto.gov
`571-272-7822
`
`
`
`
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`
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`Before ULRIKE W. JENKS, JO-ANNE M. KOKOSKI, and
`JEFFREY W. ABRAHAM, Administrative Patent Judges.
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`PGR2020-00033
`Patent 10,301,638 B2
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`APPEARANCES:
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`ON BEHALF OF THE PETITIONER:
`
`
`GARY J. GERSHIK, ESQUIRE
`Cooper & Dunham, LLP
`90 Park Avenue
`Floor 21
`New York, NY 10016
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`
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`ON BEHALF OF THE PATENT OWNER:
`
`
`MARK H. IZRAELEWICZ, ESQUIRE
`SANDIP PATEL, ESQUIRE
`Marshall, Gerstein & Borun, LLP
`233 S. Wacker Drive
`6300 Willis Tower
`Chicago, IL 60606
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`
`
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`The above-entitled matter came on for hearing on Monday, June 14,
`2021, commencing at 1:01 p.m., EDT, at the U.S. Patent and Trademark
`Office, by video/by telephone.
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`PGR2020-00033
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`P R O C E E D I N G S
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`JUDGE KOKOSKI: Good afternoon. Today we will hear
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`arguments in PGR2020-00033 concerning U.S. patent No.
`10,301,638. I am Judge Kokoski and I am joined today by Judge
`Jenks and Judge Abraham. Let's start with appearances,
`beginning with Petitioner.
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`MR. GERSHIK: Hello, Your Honors, My name is Gary
`Gershik. I'm here on behalf of Petitioner Commonwealth
`Scientific Industrial and Research Organisation of Australia,
`CSIRO for short.
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`JUDGE KOKOSKI: Okay. Thank you. Patent Owner.
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`MR. IZRAELOWICZ: This is Mark Izraelewicz from the
`firm Marshall, Gerstein & Borun. I'm here for the Patent Owner
`BASF Plant Science GMBH and with me as well on the Webex is
`Sandip Patel, lead counsel in this PGR, with my firm as well.
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`JUDGE KOKOSKI: Okay. Thank you. Consistent with
`our Hearing Order each party has 60 minutes to present their
`arguments. Petitioner will proceed first and may reserve time for
`rebuttal. Petitioner, how much time would you like to reserve
`for your rebuttal?
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`MR. GERSHIK: I'll reserve 20 minutes.
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`JUDGE KOKOSKI: Twenty minutes.
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`MR. GERSHIK: Thank you.
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`JUDGE KOKOSKI: Okay. Patent Owner will then have 60
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`minutes to present their case and may reserve time for
`surrebuttal. How much time would you like to reserve for the
`surrebuttal?
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`MR. IZRAELEWICZ: Ten minutes, Your Honor.
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`JUDGE KOKOSKI: Ten? Okay.
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`MR. IZRAELEWICZ: Yes, Your Honor.
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`JUDGE KOKOSKI: Okay. Thank you. Before we begin
`I'd just like to remind the parties that we each have a copy of
`your demonstratives and during your argument please identify
`clearly and specifically the demonstrative referenced by slide or
`screen number so that everyone can follow along and to ensure
`clarity and accuracy of the court reporter's transcript. We
`request that you keep your line muted when you're not speaking.
`Also please keep in mind that the remote nature of this hearing
`may result in audio lags so please pause prior to speaking so as
`to avoid speaking over others.
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`I'll also remind the parties that this hearing is open to the
`public and we do have an audio line open to the public today,
`therefore the parties should avoid disclosing any confidential
`information during their arguments. We will keep track of time
`and try to give you a reminder close to the end but we encourage
`you to also keep track of your own time. Okay. With that, let
`me just get the clock started, and Petitioner you can begin when
`you're ready.
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`MR. GERSHIK: Thank you, Your Honors. We're
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`PGR2020-00033
`Patent 10,301,638 B2
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`discussing U.S. patent 10,301,638, the '638 patent for short.
`This patent has issued with 23 claims. We submitted a petition
`seeking this PGR along with declaration of Dr. Yadav pointing
`out numerous issues with all of the claims. The Patent Owner
`BSAF had a chance to rebut this evidence after the PGR was
`instituted and BASF has chosen to rebut only the evidence
`insofar as it applies to claims 9 and 10. Claim 9 is one of two
`independent claims and claim 10 depends on claim 9. Thus, our
`evidence on 21 of the 23 claims is unrebutted on this record.
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`Even with respect to claims 9 and 10 we had a chance to
`cross-examine BASF's expert and that testimony resulted in
`additional evidence that could point to invalidity of claims 9 and
`10. In short, we believe that CSIRO has the preponderance of
`the evidence of invalidity for lack of enablement and lack of
`description of all of the claims in this '638 patent.
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`I'm going to get to specifics now and I want to start with
`slide 3. Slide 3 has the two independent claims, claim 1 and
`claim 9. Claim 9 is being defended by Patent Owner, claim 1 is
`not. Claim 9 is directed to oils, lipids and/or fatty acids
`produced by a transgenic Brassica plant, has to be a transgenic
`Brassica plant wherein said oils, lipids and/or fatty acids
`comprise a total amount of at least 54 percent by weight of
`polyunsaturated Omega-3 fatty acids based on the total fatty
`acids in the transgenic plant.
`Maybe I will quickly just jump to slide 10 just to
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`emphasize, just to point out and discuss briefly claim 10 which
`depends on claim 9 which is the only other claim that is being
`defended by Patent Owner. Claim 10 just says that the oils,
`lipids and the fatty acids comprise 60 to 85 percent by weight of
`polyunsaturated fatty acids based on the total fatty acids in the
`transgenic plant. Polyunsaturated fatty acids, if you will, is
`more of a class, a broad class of fatty acids and Omega-3 fatty
`acids are a subclass of these polyunsaturated fatty acids. So in
`effect claim 10 is putting a limitation of the total amount of
`polyunsaturated fatty acids whereas claim 9 is specifying that a
`subclass of these fatty acids, the Omega-3, polyunsaturated fatty
`acids is least 54 percent. These are the claims that are defended.
`Through this discussion I will probably be referring to
`PUFA P-U-F-A for polyunsaturated fatty acid and sometimes that
`PUFA will be prefaced by Omega-3 PUFA in the case of Omega-
`3 and sometimes it will just be PUFA for short.
`If we just jump back to slide 9 of our slides. That slide
`makes clear that only claims 9 and 10 are being defended and
`Patent Owner as highlighted there does not offer rebuttal to any
`other Institution grounds of the grounds for claims 9 and 10.
`If we go back up to slides 4 and 5 real quick, 4 and 5 are
`just summaries of our evidence that we presented. Ground 2,
`summary of ground 2, this is the lack of written description
`ground for a number of claims that is unrebutted. That was
`instituted and the reason (phonetic) for institution set forth there
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`as well in a short summary.
`Slide 5 talks about ground 13, also unrebutted lack of
`enablement. Claims 1 through 8 and 17 to 23 and again a
`summary together with their reasoning for institution on ground
`13. BASF has offered no rebuttal evidence to any of this and our
`view is that, and we (audio interference) of course, that there is a
`preponderance of the evidence that these claims are not enabled
`and are not described by proper written description.
`We will now -- I'd like to move to slide 6. Slide 6 is just a
`tabular form where it's just showing the grounds and indeed this
`slide, we've highlighted the claims which are dependent on claim
`9 and they are claim 11, 12, 13, 14, 15 and 16 and you'll see the
`grounds that we have presented against those claims. This is the
`lack of written description grounds and if you go to slide 7 there
`you would see the same claims highlighted but these are the lack
`of enablement grounds that we have presented. These grounds
`are unrebutted. There's no evidence from Patent Owner on any
`of these grounds for these claims.
`These claims fall squarely within claims 9 and 10. Claims
`9 and 10 encompass all of these dependent concepts. You have a
`situation here where you have a broader claim, claim 9 and claim
`10, which encompass narrow embodiments for which there is a
`substantial amount of evidence and lack of enablement and yet
`Patent Owner is requesting Your Honors to find broader claims 9
`and 10 enabled across their full scope while these dependent
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`claims 11 through 16 have been shown by a preponderance of the
`evidence that we submitted that's unrebutted to lack enablement
`across their full scope, which scope is fully encompassed by
`claims 9 and 10. We believe this is an untenable situation where
`claims 9 and 10 cannot be found enabled in the case where the
`dependent claims have such significant evidence against them in
`terms of lack of enablement (phonetic).
`Again, I just want to emphasize this is an unrebutted
`ground. We presented this in our reply and we pointed this out
`in our reply on page 25 and this is an unrebutted ground.
`Perhaps summary slide 18 can be useful just to point that out that
`this is appearing in our reply brief and of course there's case law
`on the basic premise that enablement has to be across the full
`scope. For this reason I believe that all of the claims, just for
`this reason alone all the claims should be found to lack
`enablement. But there's plenty more to discuss when it comes to
`the '638 patent.
`If we would kindly move to slide 11. We've pointed out,
`and you have instituted on the basis that the number 54 in claim
`9, which also applies to claim 10 because, if we could just
`quickly jump to the previous slide, slide 10. As you will see
`again claim 9 is providing a lower limitation of the Omega-3
`PUFA and claim 10 is saying that the total amount of PUFA is 60
`to 85 percent. Now, the total amount of PUFA can include
`Omega-3 encompasses within this definition of Omega-6 and
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`Omega-9 and other things. So what you have here is a situation
`where the 54 percent Omega-3 PUFA applies to both claims 9
`and 10. There is also discussion in the papers that the upper
`limit and whether the correct upper limit, and whether we've
`analyzed the correct upper limit as regards to claim 9 being 100
`percent while claim 10 certainly binds the upper limit to 85
`percent in total PUFA and therefore the Omega-3 PUFA cannot
`exceed the total because it is a constituent of PUFA therefore
`claim 10 would therefore encompass 54 to 85 percent Omega-3
`PUFA. There's no dispute about on that point. I think Patent
`Owner has conceded that in multiple parts of the record.
`Going back to slide 11. We pointed out you've instituted
`on the basis that 54 percent is the upper limit of Omega-3 PUFA
`simply has no written description, no support anywhere in the
`patent (phonetic).
`If we move to slide 12. The Patent Owner's position on this
`point, the written description point, has been to say initially in
`their response to say well, there are a number of disclosures of
`various percentages according to the language (phonetic)
`throughout the specification and if one were to look at those
`numbers one could select various amounts of different
`constituents if it's subparts of the Omega-3 PUFA in such a way
`so as to then once selected to add them up to make 54 percent.
`For example, the argument was and they responded well, one
`could have found for example 20 percent DPA. There's a 20
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`PGR2020-00033
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`percent disclosure of DPA, there's a disclosure of also 20 percent
`EPA. Both are Omega-3 PUFAs and also a disclosure of 14
`percent DHA, also Omega-3 PUFA and if you added those up you
`would get to 54 percent. We would of course point out that that
`is not the way that description works, that it's simply not
`sufficient to meet the written description test. This is the classic
`tree in a forest situation, blaze marks the case law language,
`there's just no basis in the law for this type of argument. We've
`pointed this out. I think we've also cited it in our reply brief, the
`Purdue Pharma, L.P. v. Faulding, Inc. case.
`On slide 13, Your Honor, if you'll move to slide 13. We
`pointed this out, this is not written description and so our
`position remains that there is really no written description,
`there's no blaze marks, there's no rationale for how 54 percent
`ever came to be. You might hear from the Patent Owner that
`there's a number like 54.6 percent in one of the tables in the
`patent, but that number notably is a TAG. TAG is a component
`of these fatty acid storage mechanisms primarily found in seed,
`but regardless the claims 9 and 10 do not require that the amount
`be relative to TAG, it is relative to the total and maybe just as a
`note, as an aside here, if Patent Owner were trying to claim --
`Patent Owner was capable of claiming TAG because dependent
`claims 11, 12, 13 at least and 15 all talk about percentage
`numbers relative to TAG. That is not what claims 9 and 10 say.
`TAG is triacylglycerides and we will see that term
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`triacylglycerides, TAG for short, you will see that term in claims
`11, 12 and 13 and so if Patent Owner wanted to write 54 percent
`relative to TAG or 54 percent of the amount of fatty acids in
`TAG being a (audio interference) that is not what claims 9 and
`10 say. Claims 9 and 10 say 54 percent relative to the total
`amount of fatty acids in the tissue. So for this reason, this is yet
`another reason why claims 9 and 10 should not be found to meet
`written description. We've spoken about enablement, now we've
`spoken about written description.
`Now we'll go back to enablement. We'll go back to claims
`9 and 10 and we'll go back to the upper limit that is in claim 10,
`the 85 percent upper limit. I would ask you to kindly go to slide
`10 again for the time being, again looking at the claims. I think
`I've already said that Patent Owner has made a case for 85
`percent being the upper limit in claim 9. We disagree with that.
`But the issue is really that in claim 10 it is the upper limit and so
`in claim 10 you do have as an upper limit 85 percent PUFA and
`if you say 100 percent of that, as Patent Owner's expert has sort
`of conceded is the meaning of claim 10, 100 percent of that
`Omega-3 PUFA could be a post (phonetic) Omega-3 PUFA. And
`so claim 10 is to read, according to Patent Owner's expert and we
`agree with this position, anywhere from 54 percent of Omega-3
`PUFA up to 85 percent PUFA and I don't think there's any
`dispute on that. I think 85 percent is fine but opposition is that
`85 percent is simply not enabled (audio interference) whatsoever
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`to enable 85 percent.
`Maybe we can jump, I'm going to jump around, I'm going to
`jump to slide 27, Your Honors. On cross-examination, so Dr.
`Sederoff is BASF's expert. We discussed with Dr. Sederoff
`whether one could reach 85 percent Omega-3 PUFAs and we've
`asked where does the patent show 85 percent Omega-3 PUFAs.
`In fact, the patent doesn't and in fact we've asked Dr. Sederoff
`well, is the patent also a way to increase Omega-3 PUFAs from
`natural levels in various tissue and even on this point, even
`though the Patent Owner has discussed this paradigm shift in
`creating additional Omega-3 PUFAs, on cross-examination even
`with reference to this line of A. thaliana, Arabadopsis thaliana,
`Patent Owner's expert conceded that the patent is not showing a
`significant increase in Omega-3 PUFAs.
`I would like to just jump back to slide 15. I'm jumping
`around here. This is a graph that we've created, this is just a
`compilation of the data in the patent and what's being shown here
`-- I'm trying to go through this quickly -- what's being shown
`here the first two graphs represent O. violaceus leaf data from
`table 2 of the patent. The next two bars are straightforward,
`represent Arabadopsis thaliana leaf data in the patent and what's
`notable right from table 2 is that when you go from wild type to
`transgenic O. violaceus leaf you only get a very, very slight
`increase of Omega-3 PUFAs of about 1.1 percent according to
`table 2.
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`Now I believe when you go to Arabadopsis thaliana you
`actually you actually get a decrease of Omega-3 PUFAs. The
`next graphs, graphs 5 and 6 they are talking about wild type O.
`violaceus leaf TAG data, that's the triacylglyceride storage data
`and then when you jump down to the bottom four that is the
`Omega-3 data that exists in table 6 that we've cited that (audio
`interference) institution decision which is showing that in
`Brassica seed, and the claims talk about Brassica plant but it's
`seed data, you're getting nowhere near 54 percent. You're
`getting very, very low data, 17 percent, 19.6 percent at the
`highest, and so nowhere near 85 percent and so what you have is
`this 85 percent upper limit in the claim and even if one were to
`look at the leaf data and even if one were to give full credibility
`to Patent Owner's argument that the leaf data somehow is
`representative -- of course it's not, we've established it's not on
`the record -- but even if you were to look at the leaf data and
`accept that argument for argument's sake you still see a wide gap
`here. There's no way in the patent to get to 85 percent. Even in
`the leaf data, not a Brassica, but even of the plants that are being
`tested, the O. violaceus plant and the thaliana plant, even if their
`leaf data and even Brassica --
`JUDGE KOKOSKI: Excuse me.
`MR. GERSHIK: Yes.
`JUDGE KOKOSKI: Counsel, this is Judge Kokoski. I have
`a question. In terms of the phrase transgenic plants, in the claim
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`how are we supposed to construe that? Is one seed a plant for
`purposes of the claim?
`MR. GERSHIK: One seed is a plant for purposes of the
`claim. There's going to be two parts to your question that I now
`want to address. I think transgenic, I don't think we have a
`dispute with the word transgenic between the parties. It is
`modified by insertion of some sort of additional gene into that
`organism. So I don't think we have a dispute. I don't think they
`have a reference (phonetic) on the point of transgenic. I think it's
`just a term that we've understood. It's not a wild type organism,
`it's an organism that's been transformed with the trans gene.
`In terms of the word plant I would like to direct you to our
`last slide 33, and I think there's been perhaps some confusion but
`I don't think there's even disagreement on definition of the term
`plant. Plant is a very broad term according to the definition in
`the patent and isn't the definition directly -- so in the bottom
`box, we're just quoting from the patent and it says plants for the
`purposes of the present invention are intact plants, et cetera,
`plant tissue, plant tissue. Any plant tissue and in the last
`sentence there it says "in this context the seed comprises," so
`seed is of course also the definition of plant, right, in biology. If
`you look seed is the third organ reference in the definition and in
`the first sentence and the second sentence and the last sentence
`of the definition it says,
`"In this context the seed comprises all parts of the seed
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`such as seed coats, epidermal cells, seed cells, any seed cells,
`endosperm or," we've highlighted the word or, "embryonic
`tissue."
`And so when you read the claims which talk about Brassica
`plant the only construction is that it is any part of a plant, every
`part of a plant, it could be a whole plant or any portion of the
`plant and again I'm not sure there's a dispute on this. I think it's
`a broad definition. I think leaf is certainly a plant according to
`the definition. A seed is certainly a plant. A part of the seed is
`a plant. Endosperm embryonic tissue of the seed, any seed cell
`is a plant for that matter according to the definition and again,
`I'm not sure there's a dispute on this point and we will hear
`Patent Owner on this point.
`So this is a very broad term and a way to interpret it is any
`transgenic, frankly plant cell would fit within the definition of
`transgenic Brassica plant. That is the way we're construing it.
`We've analyzed it in the context of the entire plant. We've also
`pointed out that the seed data nowhere matches with the numbers
`in the claim, 85 percent. No seed data anywhere in the record
`matches up with even 54 percent Omega-3 PUFA and the leaf
`data, while there's some mutator that might get there, it's in a
`different species, violaceus and thaliana and it's certainly not
`representative of what could happen in the entire claim.
`Let me jump around a bit here. I'm going to refer you to
`slide 16. We even asked Patent Owner's own expert about the 85
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`percent upper bound and we've asked if there's any data in the
`patent approaching 85 percent and the expert conceded that there
`is no data in any of it seems that reaches the maximum. In fact,
`as our slide 15 points out, the data in the patent is far short of
`even 80 or 70 percent Omega-3 PUFA even in the leaf data of a
`different species. In fact you get to numbers like 60, maybe 60
`percent, you could get 58 percent you could get there from
`transgenic thaliana, thaliana not Brassica, that’s the data in the
`patent and so our position is that this 85 percent is something not
`met and there's no teaching in the patent how to get there. No
`teaching whatsoever how to get there.
`Jumping on back to slide 16. We continued to ask Patent
`Owner's expert well, this is the middle bar,
`"Q. So if claim 9 requires a maximal level of 85 percent
`Omega-3 PUFAs, then you could have no other type of PUFA in
`the plant; correct?"
`And the answer from the expert was,
`"A. Well this is just the maximum. It's not required. If it
`was the maximum, if you had -- if -- this is very speculative."
`So I think the expert's saying look, it's very speculative you
`could ever reach 85 percent Omega-3 PUFAs. But that is exactly
`what claim 10 says. There's no limitation that there's something
`else there and I think it's an important point that even the expert
`understands. Patent Owner's expert understands that 85 percent
`is just a number as an upper limit for Omega-3 PUFAs. No way
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`to get there.
`Notably, I think BASF understood that there might be a
`problem after the deposition of the expert and in their surreply
`they offered a new argument and that's in the bottom, just
`summarized in the bottom box, that they opened a new argument
`in their surreply that says, this is some we quoted from the
`surreply,
`"A POSA was well aware that s/he could increase the copy
`number of the construct and cross-breed successive plant
`generations -- all routine plant breeding techniques -- to increase
`the production of polyunsaturated Omega-3 fatty acids to
`approach the 85 percent maximum."
`Well first of all, this is a new argument. This was not
`presented in any of the previous papers. This is not in the
`patent. The Patent Owner is not saying this copy number
`increased, increasing copy number of the construct argument on
`theory is in the patent. Not in the patent. Not in their response.
`Not supported by expert testimony and Patent Owner's expert and
`a new argument just in the surreply. Now, as a matter of fact
`this argument is wrong. If it were in fact so simple to just
`increase these Omega-3 PUFAs by increasing copy number, well
`then anybody and everybody would be doing it and there'd be no
`need for patents and development of new enzymes and new
`constructs to get there. In fact, it's not so straightforward.
`Nonetheless we don't need to say much about it, it's just a new
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`argument in the surreply. It's attorney argument, completely
`unsupported and to any scientist it is simply a false argument,
`it's technically false and so in conclusion BASF has no rebuttal
`about the upper limit issue. The upper limit is simply not
`enabled and there is nothing, nothing of record, not even
`argument, nothing. Nothing from the expert and certainly
`nothing in the patent itself to teach how a POSA or to teach a
`POSA I should say how to get to the 85 percent Omega-3 PUFAs
`in a Brassica plant, and so for this reason, for lack of meeting
`the upper boundary limitation of their claim the claims 9 and 10
`should be found to lack enablement as well as for reading
`embodiments that also covered by this (audio interference) as we
`point out.
`So that's the upper limit issue with claim 10 and now I'll
`turn to the lower limit of claims 9 and 10, same issue. As I
`pointed out claims 9 and 10 requires a 54 percent minimum
`Omega-3 PUFA level relative total, not to TAG. Maybe I should
`jump to slide 19. So this is slide 19 but data's the same data
`that's in earlier. It's just summarizing the tables in the '638
`patent and it's showing that the 54 percent threshold is only met
`by transgenic O. violaceus leaf and the transgenic A. thaliana
`leaves. T he Brassica data in the patent does not meet the lower
`limit threshold. We point this out in our petition, you've
`instituted on that ground.
`Patent Owner came back and presented what I would refer
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`to as the constitutive promoter theory. This theory, let's see
`which slide, maybe slide 21 is a nice summary of the constitutive
`promoter theory. A constitutive promoter is a promoter in a
`construct that poses expression of all tissues, it's not limited to
`just one type of tissue. A criticism that Patent Owner had about
`our citation to table 6, the Brassica data, which showed the
`you're only getting 19 somewhat percent in Brassica seed of
`Omega-3 PUFAs -- that's contained in the '638 patent -- a
`criticism that the Patent Owner made was well, table 6 and the
`data in table 6 wasn't to use any seed specific promoter, not a
`constitutive promoter which would have expressed the genes and
`the enzymes throughout whole tissues of the plant. Frankly I
`don't know why that shouldn't make the seed data higher, right,
`because it's specific to the seed and it's own specific (phonetic)
`seed one would think, but it's relevant, it's not a moot point.
`I think the point is that Patent Owner and Patent Owner's
`expert latched on to a theory that if a constitutive promoter
`(audio interference) then that same level of production of fatty
`acids would occur in all tissues of the plant. This is summarized
`in the top box on slide 21 and I'm just quoting from Patent
`Owner's response.
`"A POSA also would have known and certainly expected,"
`Patent Owner argued, "that the constitutive construct would have
`resulted in the same level of production of fatty acids caused by
`the construct throughout all tissues in the plant."
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`Dr. Sederoff's declaration said the same thing and that's the
`bottom box there on slide 21. The same level. The same level of
`production of fatty acids in all -- throughout all tissues in the
`plant, and that's from Dr. Sederoff's testimony. Well, we've
`cross-examined Dr. Sederoff on this point and Dr. Sederoff
`initially argued consistently that the same level of production
`would be expected, and this is slide 22, Your Honors. Just an
`excerpt of some testimony, which under the same level of
`production would be expected in all organs in a transgenic
`Brassica plant. We've asked her the converse (phonetic). We've
`asked her well, what do you think if, you know, what do you
`think if that wasn't the case and what if a POSA couldn't expect
`to reach the same level in all organs of the plant? What would
`happen there? And Dr. Sederoff said well, that would not
`(indiscernible) disclosure. This is just quoting from the
`deposition.
`And then we asked,
`"Q. And they also would not have a written description of
`claim 9; correct?
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`And again Dr. Sederoff said,
`"A. Yes. Correct."
`Again sticking to the theory that the same level of
`production is what a constitutive promoter would do and a POSA
`would have expected that to occur with the use of a constitutive
`promoter, and if a POSA could not have expected that then there
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`would not be enablement and there would not be written
`description.
`We've asked her if she's reviewed the literature to see if
`that theory is a solid theory. She said she went through a lot of
`publications but did not see where that issue with the
`constitutive promoter theory that she's advanced, that Dr.
`Sederoff advanced and Patent Owner has advanced, and that's a
`little excerpt there on slide 22 at the bottom, again from the
`deposition.
`Well, in fact though shortly prior to filing the '638 patent
`BASF filed another patent and I refer you to slide 23. Only
`months before they filed this patent they filed this '046 patent,
`8,134,046. It was filed by a number of the same inventors that
`are on the '638 patent and we've provided a box there listing five
`of the overlapping inventors and that patent actually refutes the
`constitutive promoter theory and in table 4, which is on our slide
`25, the '046 patent, clearly shows that a constitutive promoter
`which is what this patent was using. It was using a very
`analogous construct, practically same type of construct, very
`analogous construct and that was using the '638 patent to
`produce Omega-3 PUFAs but it did so with a constitutive
`promoter and then it analyzed the data, not just in seed tissue,
`not just in seed tissue but in all tissues and that data is
`summarized in table 4 of the '046 patent. Now for convenience
`we've summarized table 4 of this patent in our slide 26 and so
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`remember, Dr. Sederoff and Patent Owner's theory was that the
`54 percent is legitimate lower threshold and the leaf data is
`representative of what would have happened in the entirety of the
`claim. That theory was being supported by this idea that if a
`constitutive promoter had been used, unlike table 6 of the '638
`patent which used the (audio interference) but if a constitutive
`promoter had been used then the POSA woul
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