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`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`
`MERCK SHARP & DOHME CORP.,
`Petitioner,
`
`v.
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`PFIZER INC.,
` Patent Owner.
`____________
`
`Case IPR2017-02131, Patent 9,492,559 B2,
`Case IPR2017-02132, Patent 9,492,559 B2,
`Case IPR2017-02136, Patent 9,492,599 B2, and
`Case IPR2017-02138, Patent 9,492,559 B2
`____________
`
`Record of Oral Hearing
`Held: November 13, 2018
`____________
`
`
`
`Before TONI R. SCHNEINER, JEFFREY N. FREDMAN,
`JACQUELINE T. HARLOW, Administrative Patent Judges.
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`Case IPR2017-02131 (Patent 9,492,559 B2)
`Case IPR2017-02132 (Patent 9,492,559 B2)
`Case IPR2017-02136 (Patent 9,492,599 B2)
`Case IPR2017-02138 (Patent 9,492,559 B2)
`
`
`APPEARANCES:
`
`ON BEHALF OF THE PETITIONER:
`ARLENE L. CHOW, ESQUIRE
`ERNEST YAKOB, ESQUIRE
`NITYA ANAND, ESQUIRE
`Hogan Lovells US LLP
`875 Third Avenue
`New York, New York 10022
`
`
`ON BEHALF OF PATENT OWNER:
`JOHN SCHEIBELER, ESQUIRE
`White & Case LLP
`1221 Avenue of the Americas
`New York, New York 10020-1095
`
`--and—
`
`ERIC KRAUSE, ESQUIRE
`PAN C. LEE, ESQUIRE
`White & Case, LLP
`3000 El Camino Real
`2 Palo Alto Square
`Suite 900
`Palo Alto, California 94306-2109
`
`
`
`
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`The above-entitled matter came on for hearing on Tuesday,
`November 13, 2018, commencing at 1:01 p.m., at the U.S. Patent
`and Trademark Office, 600 Dulany Street, Alexandria, Virginia.
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`Case IPR2017-02131 (Patent 9,492,559 B2)
`Case IPR2017-02132 (Patent 9,492,559 B2)
`Case IPR2017-02136 (Patent 9,492,599 B2)
`Case IPR2017-02138 (Patent 9,492,559 B2)
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`P R O C E E D I N G S
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`JUDGE SCHEINER: We're going to go on the record
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`now and we're here in the matter of -- I'm not going to list all the
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`cases. The first one is IPR2017-02131 and there are three other
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`cases and it's regarding Patent 9,492,559, and we'd like to have --
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`let's see, I believe we have each side has 60 minutes, a total of 60
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`minutes.
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`Petitioner, you may reserve time for rebuttal, if you'd
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`like, and -- now, normally the rebuttal -- let me just say that our
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`practice has been in the past that you can only discuss the Motion
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`to Amend if Patent Owner addresses it, but I believe we have
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`changed that procedure now and you may address the Motion to
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`Amend in your rebuttal.
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`Let's see. All right. So if you're ready, we'll get started.
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`If you could give your name for the court reporter, please, starting
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`with Petitioner. Petitioner will go first. And would you like to
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`reserve time?
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`MS. CHOW: Yes, 30 minutes.
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`JUDGE SCHEINER: 30 minutes. Okay.
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`Case IPR2017-02131 (Patent 9,492,559 B2)
`Case IPR2017-02132 (Patent 9,492,559 B2)
`Case IPR2017-02136 (Patent 9,492,599 B2)
`Case IPR2017-02138 (Patent 9,492,559 B2)
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`MS. CHOW: But to be clear, Your Honor, in my
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`opening 30 minutes I would be permitted to address both the
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`original claims as well as the amended claims; is that correct?
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`JUDGE SCHEINER: That's correct.
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`MS. CHOW: Okay. All right. So my name is Arlene
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`Chow. I'm of Hogan Lovells. I'm on behalf of Petitioner Merck
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`Sharp & Dohme. I have here with me Ernest Yakob and Nitya
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`Anand, and from Merck I have Jim Holston, Mary Morry as well
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`as Cathy Fitch. Thank you.
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`JUDGE SCHEINER: Oh, and actually I forgot, I'm
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`Judge Scheiner and this is Judge Fredman and we have Judge
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`Harlow in Denver.
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`MS. CHOW: Thank you.
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`MR. SCHEIBELER: Good afternoon, Your Honors.
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`This is John Scheibeler from White & Case LLP here on behalf
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`of the Patent Owner Pfizer Inc. With me is Eric Krause and Pan
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`Lee also of White & Case on behalf of Pfizer. And here from
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`Pfizer are Matthew Pugmire and Keith Hutchinson. Thank you,
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`Your Honors.
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`JUDGE SCHEINER: Good morning, everyone. And
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`let me just confirm that this is a public hearing. Okay. Is that
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`correct? Okay. Because we have observers, so. Okay.
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`Whenever you're ready, Ms. Chow, you can begin.
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`Case IPR2017-02131 (Patent 9,492,559 B2)
`Case IPR2017-02132 (Patent 9,492,559 B2)
`Case IPR2017-02136 (Patent 9,492,599 B2)
`Case IPR2017-02138 (Patent 9,492,559 B2)
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`MS. CHOW: Just a bit of housekeeping.
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`JUDGE SCHEINER: Yes.
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`MS. CHOW: If Your Honors would like printed
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`copies --
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`JUDGE SCHEINER: Sure.
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`MS. CHOW: -- of the demonstratives. May I
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`approach?
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`JUDGE SCHEINER: Were you able to provide the
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`court reporter with one?
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`MS. CHOW: Yes. She has it open I see.
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`JUDGE SCHEINER: Thanks. I can't see from here.
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`MS. CHOW: Ms. Harlow, is it okay if I -- should I
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`leave it with you for --
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`JUDGE SCHEINER: That would be up to Judge
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`Harlow.
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`Would you care to have paper copies of these sent to
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`you?
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`JUDGE HARLOW: I prefer to use the electronic copy.
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`Thank you.
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`MS. CHOW: If I may proceed.
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`JUDGE SCHEINER: Please.
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`MS. CHOW: Thank you. May it please the Court.
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`There is no invention of the '559 patent. Patent Owner did not
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`Case IPR2017-02131 (Patent 9,492,559 B2)
`Case IPR2017-02132 (Patent 9,492,559 B2)
`Case IPR2017-02136 (Patent 9,492,599 B2)
`Case IPR2017-02138 (Patent 9,492,559 B2)
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`invent immunogenic 22F conjugates. Before the '559, major
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`vaccine manufacturers, Merck and GSK, made immunogenic 22F
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`conjugates with standard chemistry and techniques and they
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`published on it.
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`Now, to capture what competitors -- its competitors
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`were already making, Patent Owner patented a typical 22F
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`conjugate. Those 22F conjugates, as you can see from Claim 1,
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`fall within two extremely broad ranges, one for molecular weight
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`as depicted in yellow and one for polysaccharide to protein ratio,
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`and that's depicted in green. But those ranges were known to be
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`typical for immunogenic pneumococcal conjugates made with
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`standard chemistries.
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`If we can look at Claim 1, sole independent Claim 1,
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`you do not see any special conditions or chemistries recited or
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`required by that claim. That claim recites the term immunogenic.
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`As you can see in the second bullet -- and, Ms. Harlow, it is the
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`second bullet of slide 2. This Board has already construed that
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`term so that it elicits functional antibody against pneumococcal
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`serotype 22F.
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`The next slide, slide 3. Now, there's nothing special
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`about those broad molecular weight and polysaccharide to protein
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`ranges, Your Honors. First, the patent makes no attempt to
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`correlate functional antibody with any molecular weight and/or
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`Case IPR2017-02131 (Patent 9,492,559 B2)
`Case IPR2017-02132 (Patent 9,492,559 B2)
`Case IPR2017-02136 (Patent 9,492,599 B2)
`Case IPR2017-02138 (Patent 9,492,559 B2)
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`polysaccharide to protein range. And the patent does not provide
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`or report on a study or analysis showing claimed ranges required
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`for an immunogenic serotype 22F conjugate, and there is no
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`example of a non-immunogenic serotype 22F conjugate that falls
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`outside those broad ranges.
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`Next slide 4, please. Now, again, there's nothing special
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`about those claimed molecular weight ranges. What you see here
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`is from the specification of the '559 patent. There are over 70
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`different molecular weight ranges that are disclosed. Only one is
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`claimed. And let's look at one of those ranges, 200 and 20,000.
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`Compare 200 to the claimed range, which starts at 1,000.
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`Compare 20,000 to the claimed range which ends at 12,500.
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`Next slide 5, please. There's nothing special about the
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`claimed polysaccharide to protein ratios as well. Compare what
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`the patent discloses as an upper threshold of 3, but the claimed
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`range that ends at 2.
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`Next slide 6. Again, underscoring the fact that there's
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`nothing special about the claimed ranges, Patent Owner originally
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`claimed much broader molecular weight and polysaccharide
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`protein ranges.
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`Now if I can proceed to slide 7. It's no coincidence that
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`the prior art in this proceeding is by major vaccine manufacturers.
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`You can see it, Merck, GSK and Pfizer. After all, Patent Owner
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`Case IPR2017-02131 (Patent 9,492,559 B2)
`Case IPR2017-02132 (Patent 9,492,559 B2)
`Case IPR2017-02136 (Patent 9,492,599 B2)
`Case IPR2017-02138 (Patent 9,492,559 B2)
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`patented 22F immunogenic conjugates that its competitors
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`already knew how to make. And here you can see that
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`combination, which I will go in greater detail later.
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`But, Your Honor, it's also no coincidence that Merck
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`2011 is the primary prior art here. Pfizer wants to capture
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`Merck's 15-valent composition with these claims which are
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`directed to a standard and typical 22F conjugate, but Merck's
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`15-valent is in the prior art. It's reported in Merck 2011, and
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`Merck 2011 renders Patent Owner's overbroad patents obvious.
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`Next slide 8. I'll return to the many claims later, but I
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`just wanted to put in as an aside that recognizing the vulnerability
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`of their original claims, Patent Owner has amended them in an
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`attempt to sidestep them, but --
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`Next slide 9. As I will address later, again, those
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`amended claims do not avoid the prior art, and what you'll see
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`here is that arts by Hausdorff, which is Patent Owner, and again
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`that Merck 2011 reference, yet again, render the amended claims
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`obvious.
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`Slide 12, please. I'd like to turn to claim construction.
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`Now, if we can turn to Claim 1. Claim 1 is a sole independent
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`claim, and it's the only claim that recites molecular weight and
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`polysaccharide to protein ratio specific for 22F. Now, the claim
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`doesn't say anything about functional antibody, so the question is
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`Case IPR2017-02131 (Patent 9,492,559 B2)
`Case IPR2017-02132 (Patent 9,492,559 B2)
`Case IPR2017-02136 (Patent 9,492,599 B2)
`Case IPR2017-02138 (Patent 9,492,559 B2)
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`how did functional antibody get into the claim by virtue of claim
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`construction.
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`Next slide 13. The functional antibody requirement is
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`based on Patent Owner's representation to the PTO in order to
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`overcome the prior art. During prosecution Patent Owner relied
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`on the claimed ranges as allegedly providing functional antibody
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`against serotype 22F. Critically only the claim reciting 22F was
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`amended. No claim directed to any other serotype was amended
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`to include those molecular weight and polysaccharide protein
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`ratios.
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`Let's look at these passages from the '559 patent. Here,
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`this is Patent Owner overcoming Boutriau. It says serotype 22F.
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`This particular combination of characteristics, they produce
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`functional antibodies. Patent Owner directed the PTO to
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`Example 13. That's an example specific to 22F. And they said
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`this combination of molecular weight and polysaccharide to
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`protein ratio produced functional antibody.
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`Next slide, slide 14. Now, Patent Owner's claim
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`construction they submit that is functional antibody against all of
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`the serotypes, not just 22F that is required, is an artificial one.
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`Why, why is an artificial one in the context of pneumococcal
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`vaccines? Because Prevnar 13, which is Patent Owner's own
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`vaccine, it did not elicit functional antibody against each and
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`Case IPR2017-02131 (Patent 9,492,559 B2)
`Case IPR2017-02132 (Patent 9,492,559 B2)
`Case IPR2017-02136 (Patent 9,492,599 B2)
`Case IPR2017-02138 (Patent 9,492,559 B2)
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`every serotype. As you can see here, serotype 14, one of the
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`serotypes in its 13-valent, Patent Owner's own 13-valent, did not
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`elicit functional antibody, but nonetheless, as you can from the
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`deposition transcript of Dr. Paradiso, Patent Owner's expert,
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`Pfizer still pursued it.
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`Slide 17, please, Nitya.
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`Now, this is the obviousness ground in relation to the
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`original claim, and here Patent Owner -- what you see here is
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`prior art, again, from the three major vaccine manufacturers. And
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`Merck 2011, it teaches a vaccine with a serotype 22F conjugate.
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`There's functional antibody elicited against that serotype, and it
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`also teaches the polysaccharide to protein in the claimed range.
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`A POSA would have found the claimed molecular weight
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`desirable and obvious in view of GSK or Pfizer.
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`Let's take GSK 2008. There you have a 10-valent
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`vaccine with all of the conjugate molecular weights taught falling
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`within the broad claimed ranges of the patent. GSK specifically
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`teaches the addition of an immunogenic serotype 22F conjugate
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`to that 10-valent vaccine.
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`JUDGE FREDMAN: Now, counsel --
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`MS. CHOW: Yes, Your Honor.
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`JUDGE FREDMAN: In fact, doesn't that it -- I mean,
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`just to be fair to the Patent Owner, doesn't that 10-valent vaccine
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`Case IPR2017-02136 (Patent 9,492,599 B2)
`Case IPR2017-02138 (Patent 9,492,559 B2)
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`not include -- I mean, it has 22F in it, but it doesn't give the
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`molecular weight size of 22F.
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`MS. CHOW: And, Your Honor, if we can actually turn
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`to the table, just to slide 28. So GSK, GSK 2008, has this Table
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`2. And what you can see here is you see a full array off
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`conjugates there. And what's important to stress, just looking at
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`the yellow, Your Honor, is that this reference is proof positive
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`that the molecular weight and polysaccharide protein ratios that
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`are claimed in the '559 are typical for the immunogenic
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`And the reason why I'll say is this: In yellow every
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`single conjugate that you see there falls within the broad
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`molecular weight range of the claim. Every single
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`polysaccharide to protein ratio, likewise, falls within the broad
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`range of the patents. So, Your Honor, all of these immunogenic
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`conjugates fell within the typical and standard broad ranges of the
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`patent.
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`If you look at 22F, to go back to your question
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`specifically, Your Honor, 22F, 2.17 is the polysaccharide to
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`protein ratio that's disclosed for that particular serotype. Let's
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`compare it to PS18C. Okay. PS18C, it has a polysaccharide to
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`protein ratio of 2.2 to 2.4, very similar. And yet when you look
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`polysaccharide, it falls within -- it's yellow -- it falls within the
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`broad, broad claimed range. A POSA would have --
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`Yes.
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`JUDGE FREDMAN: For a real specific question, so
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`you say that the -- would the size, for example, of 18C coming
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`immediately out of the purification process be the same as the
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`size of 22F?
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`MS. CHOW: Your Honor, I think what matters is that,
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`nonetheless -- you're talking about the specific serotype itself.
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`conjugating them and obviously we're getting multiple
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`conjugates --
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`MS. CHOW: That's right.
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`JUDGE FREDMAN: -- in order to obtain the size here.
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`It's not a single polysaccharide, but the question, then, that
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`arises -- I'm just curious -- is, are the sizes -- initially the starting
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`size is roughly the same. Obviously serotype 18C is going to
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`always be the same.
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`MS. CHOW: They're comparable, Your Honor, and I
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`think what matters is that the polysaccharide size, you can
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`actually see it there on the left side, Your Honor.
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`JUDGE FREDMAN: Right.
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`Case IPR2017-02131 (Patent 9,492,559 B2)
`Case IPR2017-02132 (Patent 9,492,559 B2)
`Case IPR2017-02136 (Patent 9,492,599 B2)
`Case IPR2017-02138 (Patent 9,492,559 B2)
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`MS. CHOW: So polysaccharide 18 you have it at a
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`hundred and then for 22F you have it 159. What's important here,
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`Your Honor, is that these ranges are extraordinarily broad, right?
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`And what you see in the table is you see so many conjugates
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`falling within that broad range. A POSA would have found those
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`claimed ranges to be standard and typical and, likewise, also
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`extremely broad. There's a lot of -- there's variation with it, but
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`what matters doesn't matter. GSK 2008, no matter what
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`molecular weight you get, it's falling within the polysaccharide
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`protein ratio and vice versa. Okay?
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`Now, in terms of the Merck reference -- I'm sorry, if I
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`can just back -- I think we jumped ahead, but I think it's fine
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`because, Your Honor, this was actually the most critical table of
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`GSK 2008. But, again, I would say that, Your Honor, the
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`comparison of 18C and 22F does answer your questions.
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`For 424, if you can go to 24 for Pfizer. In the context of
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`manufacturing Prevnar, a pneumococcal vaccine, a POSA would
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`find the teaching significant of Pfizer's reference here, which is
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`Pfizer 2012. It involves a strategy. And what you see here, as
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`you can see the typical mass, this relates to the molecular weight,
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`it overlaps with the claimed range. Everything in the Pfizer
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`range, Your Honor, is typical and standard, including what
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`overlaps with the claimed range.
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`Slide 25.
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`JUDGE FREDMAN: That's just generic, right, it has
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`nothing to do with 22F particularly.
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`MS. CHOW: Well, Your Honor, but it has everything
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`to do with pneumococcal conjugate vaccines because this is
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`Pfizer, right? And so this is Pfizer reporting on Prevnar in
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`essence. I mean, people -- let me restate that. This is Pfizer,
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`which everybody knew was the manufacturer of a leading
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`pneumococcal vaccine, and they're saying here are the typical
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`molecular weights for conjugates. The world would have paid
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`heed to that, so I just -- I want to just reframe that appropriately,
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`Your Honor.
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`Slide 25. Now, the claimed molecular weight is typical
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`for immunogenic conjugates. And, as you can see here, we have
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`two references blown up. I'm going to focus on the one on the
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`bottom. That's Exhibit 1027, which is Wyeth 2007. This is
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`Pfizer. All right. Wyeth is Pfizer's predecessor company. And
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`what you see here is it's saying a typical conjugate of a
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`pneumococcal serotype, and it's giving ranges which, yet again,
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`fall squarely within the broad ranges of Claim 1 of the '559
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`patent.
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`Next slide 27, please. 27. Likewise, other literature
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`also supports the fact that there is nothing special about the
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`polysaccharide to protein range that's claimed within the claim of
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`the '559 patent. Here, this is the Japanese monograph for Pfizer's
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`Prevnar product and, again, you see ranges for polysaccharide to
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`protein ratio that, yet again, overlap with the very broad ranges of
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`the patents.
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`Yeah, just briefly as a reminder for Merck 2011, Your
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`Honor, slide 19, Merck 2011, as you can see, we color coded it.
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`It does teach a 22F conjugate. It, likewise, also teaches that it's
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`immunogenic. That's in the lower left-hand corner. And it also
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`teaches the polysaccharide to protein ratio.
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`But returning back to one aspect of the case here --
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`JUDGE FREDMAN: Are you actually relying on the
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`charge ratio business or not? Are you relying on the charge ratio
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`or are you sort of relying now more on the broader teachings
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`from the other references?
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`MS. CHOW: So, Your Honor, the charge, charge -- and
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`we had submitted a dictionary where the charge correlates to
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`weight as underscored by the dictionary -- the Chemical
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`Engineering Dictionary, Your Honor, so we have it both ways,
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`right? One, you have -- you have the fact that there is the range,
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`which is on the bottom for the pre-conjugate polysaccharide to
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`protein ratio, but, again, what you get in is what you get out,
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`right? And then, likewise, you also see in the upper right-hand
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`corner that the post-conjugation is 1 to 1, falling squarely within a
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`range.
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`Your Honors have decided this issue at the time of
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`Institution Decision.
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`JUDGE FREDMAN: We know that.
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`MS. CHOW: And we would submit it's been right, it
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`was right.
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`JUDGE FREDMAN: The question would be I guess is
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`one of the things you just said I wonder if there's evidence of
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`record to prove that, that the amount you put in is the amount you
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`get out.
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`MS. CHOW: Your Honor, I think what you see is if
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`you look at slide 84, right, what you see is you see that you have
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`in Merck 2011 pre-conjugation ratio 0.2 and they resulted in
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`average 1. You have the '559 patent example. It's got a
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`pre-conjugation ratio of 1 that's falling within. I think you're
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`generally seeing that they are meshing and, again, this range is so
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`broad. I mean, let's just talk about this range, right? It's a
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`massive one.
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`And if you even go to slide 86, right, even if -- let's
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`assume even if in Merck 2011 the ratio is not really 1 to 1. All
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`right. Let's say that, you know, 50 percent of it is unconjugate,
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`you're still falling within that massive range of 0.5 to 2. And
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`what's interesting is Patent Owner does not assert that the
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`polysaccharide protein ratio in Table 1 of Merck 2011 is outside
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`the claimed range of 0.4 to 2. So we submit this argument is very
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`much a red herring argument, Your Honor, because they don't
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`even argue that something is falling outside.
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`Okay. And I would like to briefly address in slide 36
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`the reasonable expectation of success in making an immunogenic
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`22F. The record stands for there being no difficulty constructing
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`immunogenic serotype 22F conjugates. The structure was
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`well-known. Both Merck and GSK obtained immunogenic
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`serotype 22F conjugates with standard chemistry. There's no
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`impediments in the literature or experience by the inventors
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`constructing such conjugates, and there's no nonstandard
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`techniques or reaction conditions identified for constructing them.
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`In fact, if you look in the lower bottom-hand corner
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`from Exhibits 1030 and 1093, what you see there is that it was
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`routine optimization to control conjugates in their molecular
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`weight size. And what's also interesting is the deposition
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`testimony in the upper right-hand corner. We asked this question
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`of Pfizer's expert, Dr. Paradiso, would it surprise you if any of
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`Pfizer's competitors, Merck, GSK, Sanofi and SK, was the first to
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`construct the serotype 22F conjugate falling within those broad
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`ranges, and he said, it wouldn't surprise me if our competitors
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`were the first, nothing special about these ranges, nothing special
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`about the claim designed to capture their competitors with
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`standard and typical ranges.
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`Next slide 37. Again, underscoring the reasonable
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`expectation of success of making immunogenic 22F conjugates,
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`here this is from Merck 2011, nothing special about serotype 22F.
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`It's not the exception to the general rule. Whenever you see those
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`exceptions, all these serotypes that are mentioned 5, 7F, 19F,
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`you're not seeing 22F mentioned anywhere as getting special
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`attention, Your Honors.
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`If I could turn to the amended claims at this juncture. Is
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`that -- yes.
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`JUDGE SCHEINER: Yes.
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`MS. CHOW: Okay. Thank you.
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`Slide 43.
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`JUDGE SCHEINER: I just want to remind you, you
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`have about 12 minutes --
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`MS. CHOW: Good. Good.
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`JUDGE SCHEINER: -- on your first 30 minutes.
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`MS. CHOW: I'm almost on target, Your Honor.
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`So recognizing the fact that the original claim was
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`vulnerable, Patent Owner amended the claim. And what's
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`interesting is they tried to sidestep the prior art by inserting -- and
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`they tried to find a loophole by inserting this 2-log increase,
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`which you see in red, and that is the 2-log increase above the
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`threshold, above the baseline in rabbits.
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`JUDGE FREDMAN: Before we go to the 2-log
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`threshold, which is clearly important, can you just talk about
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`immunogenic here? I mean, one of the issues is, do you really
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`want to argue that immunogenic doesn't require all of the
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`glycoconjugates to be immunogenic?
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`MS. CHOW: And, Your Honor, if I could just
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`underscore the fact that Claim 1 is the only claim that recites
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`those molecular weight and polysaccharide to protein ratios,
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`right? So if I could just show slide 18.
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`So during prosecution again, right, Patent Owner
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`underscored the fact that because of those two ranges, that's why
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`functional antibody was elicited against 22F. What's important to
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`understand about our construction and the Board's construction is
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`that the claim construction allows for functional antibody against
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`all of the serotypes. Okay. So it allows for all of the serotypes in
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`the vaccine composition to have functional antibody. It only
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`requires, requires that there be functional antibody against 22F
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`based, based on Patent Owner's representation during
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`prosecution.
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`And, Your Honor, if you look at these dependent
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`claims, all the dependent claims, you don't see any molecular
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`weight or polysaccharide to protein ratios recited in relation to
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`those serotypes. They're building off of Claim 1.
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`JUDGE FREDMAN: So are you contending based on
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`the statement you made earlier that Prevnar has a non-active -- I
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`mean, this is pretty much the same strains I think that are in
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`Prevnar, the additional ones that were added, correct? The
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`additional strains added in new Claim 46 are the same strains that
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`were in Prevnar, correct?
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`MS. CHOW: They were in GSK 2008 as well, Your
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`Honor, right?
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`JUDGE FREDMAN: And in Hausdorff, right?
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`MS. CHOW: Yeah, yeah, so --
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`JUDGE FREDMAN: But the question I'm asking is,
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`are there strains in there that the record shows were not capable
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`of eliciting an immunogenic response?
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`MS. CHOW: I think what the record shows is that you
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`have in GSK 2008 that for all of those additional serotypes and
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`that immunogenic in the broadest sense of whether or not it
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`induces an immune response, okay, you have disclosure in GSK
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`2008 that each and every one of those additional serotypes that's
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`recited, it's that composition is immunogenic in relation to those
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`non-22F serotypes. In our Petition of 44 and 47, GSK at Exhibit
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`1007, column 27, lines 20 to 24, we have that. Okay. We've
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`cited that in the record.
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`So, Your Honor, to the extent that the other serotypes
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`are just directed to just general immunogenicity, the prior art
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`taught that.
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`JUDGE FREDMAN: So you're distinguishing
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`essentially immunogenicity from -- I guess the reference you
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`showed it was opposite of opsono- phagocytic activity, sorry.
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`Are you distinguishing essentially that specific type of activity
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`which is a subset really of all immunogenic activities from
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`immunogenic generally which is inducing some degree of some
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`immune response.
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`MS. CHOW: That's right.
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`JUDGE FREDMAN: It could be other things other
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`than even a B cell response.
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`MS. CHOW: That's right. So when it comes to
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`serotype 22F because of the representations in the PTO, you've
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`got to have a functional antibody. When it comes to those other
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`serotypes, Your Honor, it allows for functional antibody, but it
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`also allows for just eliciting an immune response in the broader
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`Okay. In fact, this is great that we're talking about this
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`in the context of the amended claim. Because if you look at slide
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`43, the amended claim underscores why functional antibody is
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`not required for those other serotypes. Because when they had
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`the chance to fix their claim by amending it, what's interesting is
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`Patent Owner did not add functional antibody into their amended
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`claim. In fact, they didn't even discuss it in their Motion to
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`Amend papers. They walked away from their functional antibody
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`representation to the PTO and they even walked away from their
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`arguments to this Board in relation to the original claims.
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`They only added a requirement as to IgG, which is a
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`different indicia of immunogenicity, Your Honor, and I think
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`that's important to stretch, right, is that they could have put in
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`functional antibody in this claim if they really wanted to make
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`things crystal clear, but they did not.
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`Now, if I can go into the amended claims. So this
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`addition of the IgG is important to stress because it's based on a
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`fundamental mistake. When Patent Owner added this limitation,
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`they thought that they could avoid Merck 2011. What they're
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`trying to do is they're trying to capture Merck's 15-valent and yet
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`avoid the Merck 2011 reference.
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`Next slide, slide 44. That amendment is based on a
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`gross misread and oversight, Your Honor, because Patent
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`Owner's expert, Patent Owner's expert, he took the pos
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