Trials@uspto.gov Paper 85
`Tel: 571-272-7822 Date: January 27, 2025
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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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`BIONTECH SE and PFIZER INC.,
`Petitioner
`v.
`MODERNATX, INC.,
`Patent Owner.
`__________
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`IPR2023-01358 (Patent 10,702,600 B1)
`IPR2023-01359 (Patent 10,933,127 B2)
`__________
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`Record of Oral Hearing
`Held: December 10, 2024
`__________
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`Before SHERIDAN K. SNEDDEN, TIMOTHY G. MAJORS, and
`DAVID COTTA, Administrative Patent Judges.
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`IPR2023-01359 (Patent 10,933,127 B2)
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`APPEARANCES:
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`ON BEHALF OF THE PETITIONER:
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`NAVEEN MODI, ESQ.
`Paul Hastings, LLP
`2050 M Street, N.W.
`Washington, D.C. 20036
`202-551-1990
`naveenmodi@paulhastings.com
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`DAVID KRINSKY, ESQ.
`Williams & Connolly, LLP
`680 Maine Ave S.W.
`Washington, D.C. 20024
`202-434-5338
`dkrinsky@wc.com
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`ON BEHALF OF THE PATENT OWNER:
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`KEVIN PRUSSIA, ESQ.
`ANNALEIGH CURTIS, ESQ.
`Wilmer Cutler Pickering Hale and Dorr, LLP
`60 State Street
`Boston, Massachusetts 02109
`617-526-6243
`kevin.prussia@wilmerhale.com
`Annaleigh.curtis@wilmerhale.com
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` The above-entitled matter came on for hearing Tuesday, December
`10, 2024, commencing at 9:00 a.m. EST, at the U.S. Patent and Trademark
`Office, 600 Dulany Street, Alexandria, Virginia.
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`IPR2023-01359 (Patent 10,933,127 B2)
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`P-R-O-C-E-E-D-I-N-G-S 1
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` JUDGE COTTA: All right. Good morning. This is the final hearing 3
`in IPR 2023-01358 and IPR 2023-01359 regarding U.S. Patent Nos. 4
`10,702,600 and 10,933,127. The Petitioners are Pfizer, Inc. and BioNTech 5
`SE. The patent owner is Moderna TX Inc. This hearing is open to the 6
`public and a full transcript of the hearing will be made part of the record. 7
`I'm Judge Cotta and with me in the hearing room is Judge Majors, appearing 8
`remotely is Judge Snedden. Counsel for Petitioner, could you please 9
`identify yourself and your colleagues for the record? 10
` MR. MODI: Good morning, Your Honors. Naveen Modi from Paul 11
`Hastings. I'm here on behalf of Petitioner BioNTech. With me, I have my 12
`colleague Ryan Meuth. 13
` MR. KRINSKY: My name's David Krinsky. I'm here on behalf of 14
`Petitioner Pfizer, with the Board's permission, Mr. Modi and I will be 15
`splitting up the argument. And with me, well, I won't recognize absolutely 16
`everyone, but I do want to recognize that Nina Holloway, my client, is here. 17
` JUDGE COTTA: Thank you. And counsel for Patent Owner, could 18
`you please identify yourself and your colleagues? 19
` MR. PRUSSIA: Good morning, Your Honor, Kevin Prussia on behalf 20
`of the Patent Owner. I will be splitting the argument with Annaleigh Curtis, 21
`also from my firm, Wilmer Hale. With us on behalf of Moderna is Kelli 22
`Powell, who is director of patent litigation, and Dr. Jacob Moore, who is 23
`senior counsel of intellectual property. 24
` JUDGE COTTA: Very good. We look forward to the parties' 25
`presentations today. But before we get there, there are a few points that I 26
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`would like to cover. First of all this hearing is open to the public, but there 1
`have been some submissions in this case that were filed under seal. 2
` We understand from an email that we received that neither party 3
`expects their presentations will require closing the courtroom to maintain 4
`confidentiality. We share the parties' expectation that the hearing will not 5
`require either party to divulge confidential information. 6
` That said, if the argument today does take an unexpected turn, such 7
`that either party feels the need to discuss confidential information, please let 8
`us know and we will take appropriate steps to ensure that you can present 9
`the argument that you would like to make without compromising 10
`confidentiality. 11
` And we would most likely do that by allowing time at the end of the 12
`hearing to address confidential issues. In that circumstance, we don't expect 13
`that we would give you additional time to discuss the confidential issues. It 14
`would come out of the total time that we've already allocated for the parties' 15
`presentations. 16
` Finally, with respect to confidentiality, this is a very voluminous 17
`record. There's a lot to keep track of. If we, the judges, should inadvertently 18
`ask a question that starts to reveal confidential information or that requires 19
`confidential information to answer, I don't expect that to happen, but if it 20
`does, please feel free to interrupt and caution us so that we avoid inadvertent 21
`disclosure. 22
` Secondly, we have access to the entire record, including 23
`demonstratives, so when referring to each demonstrative, paper, or exhibit, 24
`please do so by slide or page number, and then pause a few seconds to allow 25
`us time to find it. 26
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` During yesterday, we received objections to demonstratives. We're 1
`not going to rule on those objections now. Demonstratives are not evidence. 2
`But if the parties wish to use the time that they've been allotted to argue their 3
`objections, they should feel free to do so. 4
` I will maintain a clock. And I will give each party a five-minute 5
`warning during their opening argument and appropriate warning near the 6
`end of any reserved rebuttal time. Our hearing room has a timer and we set 7
`it with enough for each party the requested time allotment. The light on the 8
`clock will change to yellow when you are nearing the end of your time, 9
`whether that's opening or rebuttal. And when the light is red, you will have 10
`run out of time. 11
` As far as hearing order, Petitioner, you have 90 minutes total for 12
`argument. Would you like to reserve any time for rebuttal? 13
` MR. MODI: Yes, Your Honor. I'd like to reserve 20 minutes. 14
` JUDGE COTTA: 20 minutes. 15
` MR. MODI: Thank you. 16
` JUDGE COTTA: And Patent Owner, we received a request for Ms. 17
`Annaleigh Curtis to participate under our LEAP practitioner program, and I 18
`understand that she will present at least a portion of your argument, and that 19
`entitles you to an additional 15 minutes. 20
` We remind Patent Owner that the LEAP practitioner must have a 21
`meaningful and substantive opportunity to argue during the hearing today. 22
`So with that said, you will have a total of 105 minutes. Would you like to 23
`reserve any rebuttal time? 24
` MR. PRUSSIA: Yes, Your Honor, with the panel's permission, we'd 25
`like to reserve 15 minutes. 26
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` JUDGE COTTA: 15 minutes. Okay. Petitioner you will go first as 1
`you have the burden of showing unpatentability of the challenged claims. 2
`You can begin whenever you are ready. 3
` MR. MODI: Thank you, Your Honor. Your Honor, we have a copy 4
`of our demonstratives, can we pass those to you? 5
` JUDGE COTTA: Well, we have an electronic copy, so it's not 6
`necessary. You're welcome to, and I don't know if it might benefit the court 7
`reporter if you give a copy to the court reporter. Okay. So we're all set. 8
` MR. MODI: Your Honors, are you ready? 9
` JUDGE COTTA: Yes, please begin. Oh, let me set the time. All 10
`right. You're on the clock. 11
` MR. MODI: Good morning, Your Honors. May it please the Board. 12
`Based on the petitions and supporting evidence, the Board is to conduct 13
`trials in these IPRs. The record now includes even more evidence than 14
`before that supports unpatentability. 15
` JUDGE COTTA: Can I pause for one second? 16
` MR. MODI: Sure, Your Honor. 17
` JUDGE COTTA: I just received a notice that we have more people 18
`that would like to come in, so why don't we just let them in, since you're 19
`only 46 seconds, 14 seconds in? 20
` MR. MODI: Sure. 21
` MR. PRUSSIA: I will let him have his 14 seconds. 22
` MR. MODI: As you can tell, this is why we needed a bigger hearing 23
`room. 24
` JUDGE COTTA: So I appreciate that. 25
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` MR. MODI: Thank you for accommodating us. Okay. I will just 1
`restart. 2
` Good morning, again, Your Honors. May it please the Board. Based 3
`on the petition and supporting evidence, the Board is to conduct the trials in 4
`these IPRs. The record now includes even more evidence than before that 5
`supports unpatentability. 6
` Now, as Your Honor noted, the record here is large. And while Patent 7
`Owner, Moderna, tries to muddy the waters, the issues are simple. We 8
`request that the Board hold the challenged claims unpatentable and let me 9
`explain why. Can we go to Slide 2. 10
` So we're going to divide our opening presentation into three parts 11
`today. I will begin by providing an overview of the challenged patents, the 12
`prior art, and each of the grounds, then I will address the anticipation ground 13
`based on Schrum. Finally, I will turn it over to my colleague, Mr. Krinsky, 14
`who will address the obviousness-based grounds. 15
` Of course, we're here to answer your questions, and I'm happy to 16
`focus on anything that Your Honors would like us to focus on. With that, 17
`let's go to Slide 3, please. 18
` As the Board appreciates, the breadth of the challenged claims and the 19
`teachings of the prior art will inform the discussion today. So I meant to 20
`spend a few minutes just setting the stage. If we go to Slide 4? 21
` So I mean, as both of the IPRs here involve the '600 and '127 patents. 22
`Both patents were filed during the height of the COVID-19 pandemic on 23
`February 28th, and May 21st, 2020, respectively. Both patents claim 24
`priority to provisional applications going back to October of 2015. Now if 25
`we go to Slide 5, I think we should start with what the patents tell us. So 26
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`here we have the summary of the invention, a snapshot from that summary 1
`of the invention section. 2
` And this is what the summary tells us, and this is again, from the 3
`challenged patents. It says, "Provided herein are RNA vaccines that build on 4
`the knowledge that RNA can safely direct the body's cellular machinery to 5
`produce nearly any protein of interest." 6
` So let's stand back. What is the patent telling us here? They are 7
`telling us that they have not discovered that mRNA can code and actually 8
`produce a protein. And why could they? That was well-established back in 9
`2015. Instead, they claim that the patents are directed to vaccines using 10
`mRNA technology. But as we discussed, they run right into the prior art 11
`with the broad patent claims that they have here. 12
` And let's start with those claims. Let's go to Slide 14, please. So if 13
`you look at the challenged claims, you have Claim 1 of the '127 patent, oh, 14
`sorry, the '600 patent on the top left, Claim 1 of the '127 patent here on the 15
`bottom left. So what do these claims cover? 16
` They are really broad. So if we start with the '600 patent, you can see 17
`it covers an mRNA encoding a protein, then the mRNA is formulated in a 18
`lipid nanoparticle. From there the mRNA encoded protein is a 19
`betacoronavirus S protein. That's it, Your Honors. This is a really broad 20
`claim. 21
` And then what does the '127 patent do? The only thing it adds is the 22
`language that deals with inducing an immune response. Let's go to Slide 16, 23
`please. 24
` So again, I want to step back. And really, I want to sort of stress how 25
`important it is that these challenged claims do not recite any specific 26
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`vaccine, they recite generic concepts. For instance, Patent Owner is trying 1
`to cover previous patents, mRNA is a broad structural components, where 2
`emerging COVID-19 was, as well as any other BetaCoV that might come 3
`into existence. 4
` What else? It's any lipid nanoparticle delivery system using the broad 5
`four categories of lipids at times, and use a S protein encoding mRNA. And 6
`finally for the '127, it's inducing any level of immune response, right. 7
` So again, these patents are really broad, so they run right into the prior 8
`art. And if we could go to Slide 17. The Board's aware of the grounds here 9
`of both IPRs involved, anticipation by Schrum, and then obviousness over 10
`Schrum and Geall, Yang, or Altmeyer. And like I said, I'm going to focus 11
`on the anticipation ground. So let's go to Slide 6, please. 12
` So let's start with Schrum. While it's important to remember, Schrum 13
`is a Moderna application, Patent Owner's application, that was published in 14
`October of 2013, more than two years before the provisional applications to 15
`which the challenged patents claimed priority. Let's go to Slide 7. 16
` What is interesting, Your Honors, is that Moderna actually explicitly 17
`abandoned Schrum. And that was done in August 2015. There was no prior 18
`art rejection in that application, but they still abandoned it. And what did 19
`they do after that? Just two months later, they start filing the provisional 20
`applications that the challenged patents claim priority to. 21
` And if you look at the provisional applications, they name countless 22
`immunogens, with no actual vaccines or data. What's also interesting is in 23
`the challenged patents, the challenged patents similarly recite countless 24
`immunogens and have a broad disclosure. They actually include either 25
`identical or essentially identical passages from Schrum. I want to repeat 26
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`that. The challenged patents here, include either identical or essentially 1
`identical passages from Schrum, and I'll show you a couple of those later. 2
` And they try to capture what was already disclosed, and in fact, 3
`claimed in Schrum, at least partly. So let's go to Slide 8. And I want to 4
`spend a little bit more time on Schrum and looking at it in detail. So if you 5
`look at Schrum, in the first few paragraphs of Schrum, Your Honors, this is, 6
`if you look on the slide, it's Paragraphs 4 through 8. Schrum comes out and 7
`tells us that it teaches a composition comprising a modified mRNA, 8
`encoding a protein formulated in a four-component lipid nanoparticle. You 9
`can see that here in Paragraph 8. 10
` So again, let's pause for a second. What have we learned so far? It is 11
`undisputed that mRNA encodes a protein and produces a protein, right. 12
`That's in the challenged patents themselves. It is also known that the 13
`specific protein dictates the application of the mRNA composition. So the 14
`question here becomes then, what do you do with the teachings of Schrum, 15
`and what protein do you encode? Well, Schrum also answers that question. 16
`So if you go to Slide 9. 17
` So if we look at Slide 9, this is from Schrum where it has a section, 18
`entire section on vaccines. And what does it tell us? It tells us that you can 19
`use the mRNA formulations here as a vaccine, where they can encode for an 20
`immunogen, right. You see that here. Let's go to Slide 10. 21
` What's more in that same section that we were just looking at, what 22
`does Schrum tell us? It incorporates Geall in its entirety. Again, and what 23
`does Geall provide? It provides better known immunogens that Schrum's 24
`mRNA and vaccine can encode. And as we have discussed, one of those is 25
`the BetaCoV, SARS CoV, spike protein. 26
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` Now I want to pause for a second again. If you look at the breadth of 1
`the challenged patents here, it's very similar to Schrum and Geall. In fact, 2
`the challenged patents include disclosure, again, I will say that's either 3
`identical or essentially identical to Schrum, and I will give you examples of 4
`those in a minute. 5
` And then what the challenged patents do is recite infectious disease 6
`immunogens of Geall expressly rather than through incorporation, which is 7
`what Schrum does. So they are no different from our perspective, which is 8
`why Schrum anticipates. We'll go to Slide 11. 9
` Now I think it's important to note that Schrum's teachings are all 10
`related. And you don't have to take my word for it, I actually just showed 11
`you some of the teachings of Schrum. But let's take a look at the deposition 12
`testimony from our expert, Dr. Griffin, that Patent Owner elicited during this 13
`proceeding. 14
` This is what Dr. Griffin had to say when he was asked about Schrum's 15
`disclosure. He says, "I started reading Schrum. And I'm reading the 16
`beginning of Schrum where I get an overview. Then, I move onto where I 17
`am taught about modified mRNA. I am taught about delivery systems, 18
`including LNP. Then, after a very long section on the nucleotide 19
`modifications, when I'm wondering what I'm going to do with this 20
`technology." 21
` What happens? "I then come across a section that starts bottom of the 22
`right page, just right above paragraph 340, where I am now taught that I can 23
`use this technology to make a vaccine." What's more, he says, "I am 24
`directed to reference Geall, which is incorporated in its reference as if it 25
`were stapled to the back of Schrum. There's a list of pathogens for which I 26
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`can use this technology to make a vaccine. And in the list of pathogens is 1
`coronavirus, which is in the list of top ten pathogens of emerging pathogens 2
`of pandemic potential in 2015." 3
` So what he is telling us there is that some -- Geall teaches us the top 4
`ten pathogens that were a problem, and that was a known problem in 2015. 5
`And then he says, "As I'm reading this as a person of ordinary skill, I see 6
`only a coronavirus mentioned on the bottom of page 19, but specifically the 7
`S protein is called out as a protein that I can make with this technology in 8
`vaccine design." 9
` So I want to pause there for a minute. This is testimony from one of 10
`skill in the art, Dr. Griffin. And if the Board may recall, the person of 11
`ordinary skill is remarkably educated and experienced, regardless of whose 12
`definition the Board uses. In fact, it's a team that's the person of ordinary 13
`skill in the art. So it's incredible for Moderna to come here and say the 14
`claims are unanticipated or rendered obvious in light of the skill of the 15
`person of ordinary skill in the art. If we go to Slide 12. 16
` There's more than Schrum, Your Honors. So this is Paragraph 397 17
`from Schrum, and what does this teach us? In Paragraph 397, in one place it 18
`teaches us the user of -- encoding mRNA formulated in a lipid nanoparticle 19
`as a vaccine used to elicit an immune response. Now they have some 20
`arguments on Paragraph 397, they're trying to parse it, they're like no, it only 21
`refers to modified mRNA, not modified mRNA, but as we will discuss, it 22
`clearly does. Again, all of the teachings of Schrum are related. 23
` But here's the interesting point. Remember I kept saying that they 24
`take passages of Schrum, they have been put into the '600 and '127 patent. 25
`I'd actually like to show you that they have a copy of 397 that's essentially 26
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`identical to what's in Schrum. Can we pull up Column 85 of the '127 patent, 1
`please? 2
` And while Ryan is pulling that up, Your Honors, it's interesting to 3
`note, right, today they want Your Honors to say, well, 397 is not related to 4
`the intervention of Schrum, it's different. But like I said, an essentially 5
`identical version of that paragraph is in the '600 and '127 patents. And why 6
`is that important? 7
` It's important because it tells us that Paragraph 397 is a disclosure of 8
`an mRNA LNP vaccine, and that the challenged patents are not directed to 9
`anything new. What's more, they actually cited to this paragraph of Schrum 10
`as support in response to a rejection under Section 112 in the '127 patent, 11
`Your Honors. And you can find that, that's at Exhibit 1008 at 488. And 12
`Ryan can you zoom in to Column 85, Lines 47 to 58, please? So you can 13
`see it right there, Your Honors. 14
` This is again, the '127 patent, Column 85, Lines 47 to 58. What does 15
`the '127 patent give you? An identical copy of Paragraph 397. In some 16
`embodiments an immune response may be elicited by delivering a lipid 17
`nanoparticle which may include an immunogen, and then it says, it tells each 18
`of which may be incorporated by reference in their entirety. The polymer 19
`may encapsulate the nanospecies or partially encapsulate the nanospecies. 20
`The immunogen may be -- 21
` JUDGE COTTA: I'd like to interrupt for a second. 22
` MR. MODI: Sure, Your Honor. 23
` JUDGE COTTA: This is all new argument, isn't it? 24
` MR. MODI: So, Your Honor, this is in response to their argument 25
`and their sur reply, which we didn't get a chance to respond to, where they 26
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`argued that 397 doesn't disclose modified mRNA. And from our 1
`perspective, this is certainly part of the record, and it shows that why 2
`paragraph 397 here does tie everything together. And even if you don't look 3
`it together, we still win. I just think it's telling that they have paragraphs like 4
`this incorporated in the '600 and '127 patents. 5
` JUDGE COTTA: And looking just at Schrum, what does Schrum tell 6
`us in terms of this being mRNA? 7
` MR. MODI: Sure, Your Honor. And we can actually jump to that. 8
`So if you can go to Slide, let's go to Slide 54, please. So if you look at 54, 9
`what we have here is Paragraphs 340, which is the vaccine fraction on the 10
`left. You have Paragraph 378, which is the section that deals with the lipid 11
`nanoparticles. And then we have Paragraph 397. So we get to the mRNA 12
`encoding vaccines in Schrum in two ways, so the mRNA encoding the 13
`immunogen in two ways, at least two ways, I would say. 14
` The first is you have Section 340, right, which is a vaccine section. 15
`And that tells us that you have mRNA molecules may be used to elicit or 16
`provoke an immune response. And then Paragraph 342 is not here, but 342 17
`also tells us that may be the modified mRNA. And then what does Schrum 18
`tell us a few pages later? It gives us Paragraph 378. And what does 378 19
`say? It says the modified nucleic acid molecules and mRNA of the 20
`invention can be formulated using one or more liposomes, lipoplexes, or 21
`lipid nanoparticles. So that's one way how we get to the mRNA encoding an 22
`immunogen. 23
` The second way to get to it is through Paragraph 397, again, in one 24
`place. So if you look at Paragraph 397, it's in the same section where 25
`Paragraph 378 is, right. And what does it tell us? It says, "Like Paragraph 26
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`340, it tells us in one embodiment you have an immune response, may be 1
`elicited by delivering in lipid nanoparticle which may include a nanospecies, 2
`a polymer, and an immunogen". It doesn't stop there. It goes on and says, 3
`"The immunogen may be a modified RNA as described herein". And of 4
`course, that talks about a modified RNA described therein, it's talking about, 5
`for example, the modified RNA that we have in Section 342 and 340. 6
` JUDGE COTTA: Is there anything else that a modified mRNA, I'm 7
`sorry, a modified RNA as described herein could refer to other than mRNA? 8
` MR. MODI: So two responses to that, Your Honor. First is that, 9
`Moderna, it's in Patent Owner's response, and I'm going to give you the cite 10
`to this. They actually agreed with us that this paragraph does refer to 11
`mRNA. And that's at Patent Owner Response 22. 12
` What they said there was one -- so remember they are saying 397 has 13
`two embodiments. And they say, well, the first one includes a vaccine, but 14
`no mRNA, the second includes mRNA but no vaccine. Right. That's what 15
`they said in their Patent Owner response. But in their sur reply, they were 16
`obviously saying something different. 17
` So from our perspective, Your Honor, this paragraph, and it talks 18
`about modified RNA, it is talking about modified mRNA. And like I said, if 19
`you look, just compare the two patents next to each other. It uses very 20
`similar language. 21
` And then the second point that I wanted to make was, if you look at 22
`some of the other things that they're pointing to for modified RNA, right. 23
`They're pointing to things like siRNA, and they are saying RNAi, but those 24
`don't encode proteins, they in fact, inhibit expression. So their argument just 25
`doesn't hold water. 26
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` And then like I said, at the end of the day, the problem that they have 1
`is all of these teachings of Schrum are inter-related. And once I note again, 2
`with respect to Paragraph 378, that we just looked at, that's actually on the 3
`slide, on 54. Again, I think, Your Honor, it's telling. They today, want to 4
`run away from their disclosure of Schrum. But if you actually look at their 5
`own disclosure, again, Paragraph 378 also exists in essentially identical form 6
`in their own disclosure. 7
` And that's at, for example '127 patent, Column 76, Lines 27 to 47. So 8
`from our perspective, it's all the, it's in one place, Schrum clearly teaches the 9
`mRNA that's encoding an immunogen for a vaccine in one place. 10
` JUDGE MAJORS: Mr. Modi, Patent Owner cites some testimony 11
`from your expert, Dr. Moon. The Patent Owner says to the effect that 12
`Paragraph 397 disclosed multiple embodiments, not one embodiment in 13
`there. What's your response to that? 14
` MR. MODI: We disagree, Your Honor. And I think we actually have 15
`testimony from Dr. Moon that that's one of the slides, so why don't we look 16
`at it. So if you go to Slide 55. So this is testimony from Dr. Moon. And 17
`you can see that this is what he said in Paragraph 35 of Exhibit 1161. 18
` He said, "A person of ordinary skill would have readily understood 19
`that Schrum's disclosure that 'an immune response may be elicited by 20
`delivering a lipid nanoparticle' refers to a lipid nanoparticle-based vaccine 21
`composition. In fact, Schrum uses nearly identical language in its discussion 22
`of mRNA vaccines. Under the heading, 'Activation of the Immune 23
`Response: Vaccines,' Schrum teaches that '[i]n one embodiment of the 24
`present invention, mRNA molecules may be used to elicit or provoke an 25
`immune response in an organism.' Moreover, under the same 'Vaccines' 26
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`heading, Schrum also explains that the mRNA vaccines can 'encode an 1
`immunogen,' consistent with paragraph 397's reference to a modified mRNA 2
`immunogen". 3
` And if we go to Slide 56, there is more there, Your Honor. And I 4
`think it's actually telling, and I know Your Honors will do this, when we 5
`look at the testimony of our experts and their experts, for example, Dr. Chan, 6
`he was trying parse Paragraph 397, and he was contradicting himself. He 7
`said well, you know, it refers to the lipid nanoparticle and that's magic and 8
`then, right. But I think from our perspective, it's their reading of 397 when it 9
`refers to the lipid nanoparticle, if you can go back onto the previous slide. 10
`All it says is the lipid nanoparticle may be formulated. 11
` And of course, it's the lipid nanoparticle that's referenced in the first 12
`sentence of 397. But again, I think the Board can lose sight of the fact, these 13
`teachings are all related, Judge Majors. And if you go back to Slide 58, 56, 14
`sorry. We have more testimony from Dr. Moon here, which again shows 15
`why Paragraph 397 in one place discloses what's claimed. 16
` JUDGE MAJORS: Before we move off this topic, with respect to the 17
`method claims, can you help me understand where in Schrum there's a 18
`disclosure of the neutralizing antibody response that's recited in Claim 3? 19
` MR. MODI: I'm happy to, Your Honor. I'm happy to. So if you 20
`could go to Slide 34, please. So if we look at, we have a couple of 21
`arguments here, Your Honor, on Claim 3, right. I think that is the claim you 22
`were directing, you were referring to. Again, it's a very broad claim. All it 23
`says is "The method of claim 2, beyond the immune response is a 24
`neutralizing antibody response specific to the BetaCoV S protein". 25
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` So two arguments in response to this claim. One is, we believe this is 1
`-- all this is claiming is an intended result. And as Your Honors know, that's 2
`black letter law, it's not patentable. Go to Slide 35. We actually made this 3
`argument in our petition, you can see that here. 4
` We have not received a response from Moderna to this day to this 5
`argument. So for this reason alone, we think that Claim 3 is unpatentable. 6
`And if you actually look at the testimony we have from the expert, from 7
`their expert, Dr. Fuller, and within that deposition that whether a vaccine's in 8
`use and immune response just depends on the entity they're expressing. And 9
`that's Exhibit 1104, 52, 10 through 13. 10
` And so of course, she's explaining that again, this is just an intended 11
`result, right. And then if you go to Slide 36, again, black letter federal 12
`circuit law claiming results is simply not patentable, the Allergen case tells 13
`us that it cites to average lots, and it tells us that. But even if this Board 14
`were to give this claim weight, let's go to Slide 37 and then we address, 15
`Judge Majors, of how we get to neutralizing antibodies, if you were to give 16
`this claim weight. 17
` So again, let's go back to Schrum, let's start with Schrum. What does 18
`Schrum teach us? It says, "In one embodiment of the present invention, 19
`mRNA molecules may be used to elicit or provoke an immune response in 20
`an organism. The mRNA molecules to be delivered may encode an 21
`immunogen peptide or polypeptide." It doesn't stop there. 22
` Item 342 tells us, "the modified nucleic acid molecules and/or 23
`mmRNA of the invention may encode an immunogen." What else does it 24
`tells us? I think this is the language that is fatal to that, their argument here. 25
`It says, "the modified nucleic acid molecules and mmRNA of the present 26
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`invention encoding an immunogen may be delivered to a vertebrate in a dose 1
`amount large enough to be immunogenic to the verbetrate." Right? 2
` Obviously, once by definition immunogenic, what does that mean? 3
`Well, it's inducing an immune -- a response. And what Schrum is doing 4
`right there, is incorporating by reference Geall. So let's take a look at Geall's 5
`teachings and what does Geall tell us? So if you go to Slide 38, what does 6
`Geall tell us? It says that you have anticipation of the RNA, the immunogen 7
`is transmitted in vivo, and can elicit an immune response in the recipient. 8
` And goes on to say the immunogen may elicit an immune response 9
`against a virus and of course, that's BetaCoV, as one example. And it goes 10
`on and says, "the immune response may comprise an antibody response," 11
`right. And what else does it teach? It says, "the immune response is 12
`preferably protective and preferably involves antibodies." 13
` Now, let us step back for a minute. Why does then Schrum and Geall 14
`teach us this? Well, because we have testimony from both experts here, 15
`Your Honors, that says the protected immune response encompasses a 16
`neutralizing antibodies response. I