Trials@uspto.gov
`571-272-7822
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`Paper No. 26
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`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_______________
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`NEW U LIFE CORPORATION
`Petitioner,
`
`v.
`
`AXCESS GLOBAL SCIENCES, LLC
`Patent Owner.
`_______________
`
`IPR2019-01141
`Patent 6,613,356 B1
`_______________
`
`Record of Remote Oral Hearing
`Held virtually: Tuesday, September 1, 2020
`_______________
`
`Before GEORGIANNA W. BRADEN,
`JENNIFER MEYER CHAGNON, and
`MICHAEL A. VALEK, Administrative Patent Judges.
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`571-272-7822
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`Paper No. 26
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`
`
`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_______________
`
`NEW U LIFE CORPORATION
`Petitioner,
`
`v.
`
`AXCESS GLOBAL SCIENCES, LLC
`Patent Owner.
`_______________
`
`IPR2019-01141
`Patent 6,613,356 B1
`_______________
`
`Record of Remote Oral Hearing
`Held virtually: Tuesday, September 1, 2020
`_______________
`
`Before GEORGIANNA W. BRADEN,
`JENNIFER MEYER CHAGNON, and
`MICHAEL A. VALEK, Administrative Patent Judges.
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`IPR2019-01141
`Patent 6,613,356 B1
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`APPEARANCES:
`
`ON BEHALF OF THE PETITIONER:
`
`
`BRIAN GALVIN, ESQUIRE
`GALVIN PATENT LAW, LLC
`brian@galvinpatentlaw.com
`
`
`
`ON BEHALF OF THE PATENT OWNER:
`
`
`RYAN E. HATCH, ESQUIRE
`LAW OFFICE OF RYAN E. HATCH
`ryan@ryanehatch.com
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`The above-entitled matter came on for hearing on Tuesday,
`September 1, 2020, commencing at 10:00 A.M. EST, by video/by
`telephone.
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`IPR2019-01141
`Patent 6,613,356 B1
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`P R O C E E D I N G S
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` JUDGE VALEK: Good morning, this is the
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`final hearing in IPR2019-01141. The Petitioner is
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`New U Life Corporation, the Patent Owner is Axcess
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`Global Sciences, LLC. This hearing is open to the
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`public, and a full transcript of the hearing will
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`be part of the record. I'm Judge Valek, with me
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`is Judge Braden and Judge Chagnon.
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` Would counsel for Petitioner please
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`identify who is present today on behalf of
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`Petitioner and who will be speaking.
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` MR. GALVIN: Yes, this is Brian Galvin,
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`from Galvin Patent Law. I am lead counsel for
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`Petitioner, New U Life, and I will be speaking. I
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`believe my backup counsel, Vanessa Bowman Pierce
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`[ph], will be on audio only, listening.
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` JUDGE VALEK: All right. Thank you,
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`Counsel.
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` Counsel for Patent Owner, would you please
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`identify who is present today on behalf of Patent
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`Owner and who will be speaking.
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` MR. HATCH: Good morning, this is
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`Ryan Hatch on behalf of Axcess Global Sciences,
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`the Patent Owner. And I'm the only one present
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`IPR2019-01141
`Patent 6,613,356 B1
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`and I'll be speaking.
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` JUDGE VALEK: Very good. As indicated in
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`the trial order, each side will have 45 minutes to
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`present its case. I will be keeping track of
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`time, but I suggest the parties do so as well.
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`Petitioner will present its argument first,
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`followed by the Patent Owner.
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` Counsel for Petitioner, would you like to
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`reserve any time for rebuttal?
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` MR. GALVIN: Yes, I plan on reserving
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`15 minutes for rebuttal.
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` JUDGE VALEK: All right. Counsel for
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`Patent Owner, you may have the last word today, if
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`you wish. Would you like to reserve any of your
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`time?
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` MR. HATCH: Yes, I would. I would also
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`like to reserve 15 minutes.
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` JUDGE VALEK: Very good. Before we begin
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`the parties' presentations, I would like to go
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`over a few things. First, on behalf of the board,
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`we thank you, everyone, for your flexibility in
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`participating in this all-video hearing. Given
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`that this is a departure from our typical
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`practice, I would first emphasize that our primary
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`concern is your right to be heard. If, at any
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`time during the hearing, you encounter technical
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`Patent 6,613,356 B1
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`or other difficulty that you feel fundamentally
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`undermines your ability to adequately represent
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`your client, please let us know immediately, for
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`example, by contacting the team members who
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`provided you with connection information.
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` Second, to help with the transcript, we
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`ask that you identify yourself each time you speak
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`and mute your microphone when you're not speaking.
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`Be mindful that there can be a lag in audio and
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`video, so please pause before speaking to help us
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`avoid speaking over each other.
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` The panel has access to the entire record,
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`as well as your demonstratives, so if you refer to
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`a page or the exhibit in your arguments, give us a
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`few moments to get there so we can all be on the
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`same page, literally.
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` And, then, fourth, plan to stay on the
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`line afterwards to answer any questions the court
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`reporter may have afterwards, regarding spellings
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`or other clarifications for the transcript.
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` Finally, should you come to a good-faith
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`belief that the pace of this proceeding prevents
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`you from adequately explaining your position,
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`please speak up and we'll consider some expansion
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`of your time. There are no pending motions in
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`this proceeding, therefore, it is our expectation
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`that the arguments today will focus on the
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`instituted grounds and the claims in the petition.
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` With that, does either side have any
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`questions before we turn on the timer and begin
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`argument?
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` MR. GALVIN: None for Petitioner.
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` MR. HATCH: Not for Patent Owner.
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` JUDGE VALEK: All right. Mr. Galvin, you
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`have the floor. You may begin Petitioner's
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`argument.
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` MR. GALVIN: Thank you, Your Honors, and
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`good morning. Thank you for taking the time.
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`Again, this is Brian Galvin, for Petitioner, New U
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`Life. I'm going to proceed chronologically, and
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`sort of describe the development of the state of
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`the art, as well as the procedural steps that took
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`place, starting with the filing of the patent;
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`and, as I go, I'll also talk on some of the issues
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`dealing with who has the burden and presumptions
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`and so forth, because some of those are relevant
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`for what we're dealing with.
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` So back in 1983, Pawan and Simple did an
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`experiment working with some doctors in their
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`hospital, checking out whether oral administration
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`of sodium -- or beta-hydroxybutyrate would -- I
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`believe it was sodium -- would benefit people who
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`IPR2019-01141
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`were undergoing rapid weight loss therapy, either
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`through therapeutic starvation or
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`energy-restricted diets. So in 1993, they showed
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`and published that BHB is effective to suppress
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`appetite. And, also, when I say "BHB," I'm
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`referring to beta-hydroxybutyrate; "GHB," will be
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`gamma-hydroxybutyrate; and "AHB," will be
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`alpha-hydroxybutyrate.
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` So Simple and Pawan -- or Pawan showed
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`that BHB is effective for appetite suppression,
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`and also that it is effective for reducing protein
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`catabolism, which is shown by the -- what they
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`show is the decrease in urinary nitrogen.
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` Then, moving along, in 1992 -- this was
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`Exhibit 1026. I don't think we need to go there
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`right now, we'll talk about it later, but this was
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`the -- GHB was already, at that point, a
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`well-known illegal drug. It was banned by the
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`FDA. It had -- it's a neurotransmitter. So in
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`1992, GHB was understood to be a party drug and
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`was illegal.
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` In 1999, Martin built on Pawan, so he
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`filed a patent application, which basically
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`acknowledged Pawan, and took, as a given, that BHB
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`was effective at suppressing appetite and in
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`suppressing protein catabolism while on a
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`Patent 6,613,356 B1
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`ketogenic diet. And he is addressing the problem,
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`which is a known problem in the industry, which
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`is, it's hard to stay on a ketogenic diet. And he
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`stated, citing Pawan, that it was known to use
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`dietary supplementation of BHB to assist in
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`maintaining ketone levels in the blood with
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`nonketogenic diet, and he was going for sustained
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`bioavailability. So he was focused on oligomeric
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`compounds of BHB and other ketones, but he started
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`with the assumption that BHB can suppress appetite
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`and can assist by -- a ketogenic lifestyle by
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`reducing protein metabolism. So that's all prior
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`to the Vlahakos patent.
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` In 2000, the Vlahakos patent, the '356
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`patent at issue here, was filed by Dr. Vlahakos,
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`and in that patent -- and now, if you want to
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`refer to demonstrative page No. 2, and I'll only
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`be referring to page numbers from my Petitioner's
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`demonstrative exhibits.
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` So page 2, Vlahakos started by
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`hypothesizing, and he was very focused on butyrate
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`and not on BHB. And his hypothesis was that the
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`stomach has sensors for butyrate, and these
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`sensors pick up a signal. If there are bacteria
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`in the stomach, the bacteria ferment, create
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`butyrate, and that causes you to feel full. And
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`that was sort of the governing hypothesis that led
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`him to undertake some testing.
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` So the focus is on appetite suppression
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`and on butyrate. So he did some testing on
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`himself and his wife, and the results are shown
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`here, on page 3. So on page 3, you can see on the
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`left is the results for subject No. 1, which was
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`Dr. Vlahakos. And he managed to lose, he went
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`from 185 to 168 over a period of seven months,
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`that's like three pounds a month. And during that
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`time, he was living a normal life, presumably, so
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`there was no measurement -- well, there was one
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`measurement after two months of weight reduction,
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`but there was no measurement of the BHB
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`concentrations or anything, and there's no record
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`of what else was going on in his life.
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` And, on the right, is his wife, who went
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`from 256 pounds to 220 pounds over a period of six
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`months, so that's about five pounds a month. And,
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`again, there was varying doses throughout these
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`two tests, and the weight loss was modest, but
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`real, but we don't know whether it was due to the
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`mechanism hypothesized or, indeed, due the
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`butyrate at all.
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` And, again, the only thing they
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`administered orally was potassium butyrate, which
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`was the entire focus of his patent, of his work,
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`and which is consistent with his hypothesis in
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`page 2.
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` So then he went on to generalize, and he
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`said, based on the fact that there are a number of
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`chemical compounds that are closely related to
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`potassium butyrate, and he hypothesized or assumed
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`that they would have similar appetite suppressing
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`effect on the stomach, because it would,
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`essentially, trick the stomach receptors. They
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`would erroneously sense the same thing.
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` And so his hypothesis was that any of
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`these other things, which ultimately became the
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`Markush group, would suppress appetite in the same
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`way as potassium butyrate did in his fairly
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`unscientific test on two people.
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` He did also do some mouse testing and
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`measured when they would get colitis. Colitis, by
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`the way, is colon inflammation, and we have some
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`evidence that we probably won't discuss, but it's
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`in the record, that shows that most of the
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`butyrate sensors are in the colon of humans. So
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`it's the hypothesis -- the method is probably not
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`correct, but the fact that GHB and sodium
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`potassium butyrate suppress appetite can certainly
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`be taken as a given.
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` However, I will call your attention to the
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`fact that this preMarkush group, if you will, the
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`statement in Vlahakos where he justifies what also
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`is the Markush group in Claim 1, omits
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`gamma-hydroxybutyrate. Now gamma-hydroxybutyrate
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`is exactly -- is as closely related to butyrate or
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`potassium butyrate as is alpha-hydroxybutyrate or
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`beta-hydroxybutyrate. The three of them have the
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`same -- they each have an extra hydroxyl ion in
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`place of a hydrogen. In alpha, it's at the two
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`position; in beta, it's at the three position; in
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`gamma, it's at the four position; so they're
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`equally related physically or chemically to
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`potassium butyrate, but they're omitted from this
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`list.
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` Now, remember that, already, by '92, GHB
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`was a well-known party drug, it's an elicit drug,
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`it's used as a sedative. So you know, from one
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`perspective, it would make sense to leave it off
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`since, you know, it has very different effects.
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`But my point, really, is going to be that all of
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`these have very different biological effects. And
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`his statement that it was commonly known -- that
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`it was believed that they would all have the same
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`effect, is false. But at this point, it's
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`presumed to be true, and I don't dispute that.
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` And that leads directly to Claim 1, which
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`has the Markush group, which we'll be talking
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`about a lot today, and I'm not going to read the
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`claim, I'm sure we're all very familiar with it,
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`but it lists butyric acid, AHB, GHB, and
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`isobutyric acid, but it does not list -- and their
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`salts, simple salts, but it does not list GHB.
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` So at that point, the -- Vlahakos has been
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`in control at this point, because he hypothesized,
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`he tested, he generalized. Based on his test
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`results, he claimed and then he prosecuted, in
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`2001 to 2002, during which the prosecution
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`history -- during which the emphasis was on the
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`appetite suppression effects and the fact that
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`butyrate is what causes it. A lot of the effort
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`went into saying that potassium had no suppressive
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`effect on appetite, and he got his patent. Okay.
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`So that's all in the past, and that brings us to
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`last June, when the Petitioner challenged the
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`patent in this IPR.
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` Now, under Section 311, when the
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`Petitioner challenged the patent, the Petitioner
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`is limited to Sections 102 and 103, using the
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`patent and printed publications, and the
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`Petitioner is the master of his petition, as the
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`Supreme Court stated in Sass [ph], and, obviously,
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`we don't dispute that.
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` So at this point, the Petitioner is in
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`charge and defines the scope, and the scope is
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`statutorily limited to 102 and 103, and to patents,
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`and printed publications. So at that point in the
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`petition, we led with Pawan as anticipating
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`Claim 1, and rendering -- either anticipating or
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`rendering Claims 14 and 17, which are the three
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`independent claims, unpatentable.
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` And in focusing on Pawan on page -- you go
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`to page 6, if you recall, Pawan showed in his
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`experiment that GHB orally administered was
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`effective in suppressing appetite and also in
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`reducing protein catabolism during -- in this
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`case, very severe therapeutic weight loss therapy.
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`Because these are people, if you recall from
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`Pawan, these are people medically being treated
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`not just for obesity, but rapid weight loss so
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`they can get ready for surgery and avoid
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`deleterious effects on wound healing by gross
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`obesity.
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` So these are people on a crash course of
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`weight reduction, and when you're on a crash
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`course, either through therapeutic starvation or
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`energy restriction, one of the challenges is that
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`your body will burn protein in order to feed
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`itself, and so you end up with a lot of muscle
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`wasting and so forth. And BHB was shown in Pawan
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`to be effective for appetite suppression and for
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`reducing protein catabolism, both of which were
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`effects that were desirable in a regimen that's
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`targeted at weight loss or prevention of weight
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`gain -- in this case, weight loss.
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` So therefore, Pawan anticipates in a very
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`straightforward way, and so this result here, in
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`page 6, shows the -- basically, it goes to the
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`discussion that Patent Owner will likely bring up,
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`which is about, you know, whether or not Pawan
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`actually proves that BHB causes weight loss, which
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`is not what needs to be proved. What needs to be
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`proved is that Pawan teaches the oral
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`administration of BHB in that -- for the reduction
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`of -- correction, for the causing of weight loss
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`or prevention of weight gain. It doesn't need to
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`be the only thing that is done for that, but if it
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`is done as part of a process to do that, that
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`would count.
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` And, also, Pawan did show that it
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`suppresses appetite, which clearly is one way of
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`reducing weight. So it was shown to be effective
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`in preventing weight gain or causing weight loss,
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`at least through appetite suppression. And
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`because if you're doing ketogenic diet, or if
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`you're doing therapeutic weight reduction, you
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`want to prevent the negative effects, so by doing
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`-- having BHB, you also reduce protein catab- --
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`catabolisms. Sorry.
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` Okay. So his conclusion restates that on
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`page 7, that, you know, net protein body loss is
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`caused by the very low energy or by starvation,
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`and he also discusses that appetite suppression
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`was experienced by all of the people who received
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`BHB. And indeed, he points out at one point that
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`the people in the energy-restricted diet reported
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`reduced appetite when they were taking BHB. So
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`when they were taking glucose, they didn't report
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`presumably -- we don't really know, but he called
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`out that when they were being administered BHB for
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`a three-day period, either at the beginning or at
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`the end of their process, they reported reduced
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`appetite. So Pawan was very clear that BHB
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`reduces appetite.
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` Martin relied on that. Martin also
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`anticipates Claim 1, and I'm not going to go
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`through Claim 14 and 17 in detail, it's all in the
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`petition and the record, and the board agreed, but
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`Neesby and Moran both teach that you can
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`administer BHB with caplets or capsules, and
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`discussed various reasons why you might want to.
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` So combining Pawan or Martin -- and Martin
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`doesn't just restate Pawan, but it actually
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`extends Pawan, but it does talk about BHB and its
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`oligomers as being orally administered for
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`supporting a ketogenic lifestyle by reducing
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`appetite.
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` JUDGE VALEK: Counsel -- Counsel?
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` MR. GALVIN: Yes?
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` JUDGE VALEK: Counsel, this is
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`Judge Valek. I have a question. You said that
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`Martin "extends" Pawan? In what ways do you
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`contend that it "extends" Pawan?
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` MR. GALVIN: Well, Martin's purpose, he
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`starts by citing Pawan and just talking about the
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`background of the art extensively, and Pawan was
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`one of the things he cited, and he says it's
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`understood that, you know, dietary supplementation
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`of BHB can suppress appetite and reduce protein
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`catabolism, but he wanted to provide a more
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`sustainable bioavailability of the ketone body,
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`which is BHB, and so he focused on figuring other
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`ways to supplement with oligomers of BHB and other
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`related chemicals so that you would have a
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`sustained effect.
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` Because it would take time for those
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`Patent 6,613,356 B1
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`oligomers to break down to the monomers so you
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`have a buildup and sustained introduction of BHB
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`into the blood, and, therefore, you would get a
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`longer period when you were getting the benefits
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`for ketogenesis by taking it in a oligomeric form,
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`although he does teach the monomeric form as well
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`throughout his patent.
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` But that was his focus, was going beyond
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`what Pawan and others had done in the art and
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`actually creating a more effective BHB therapy or
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`ketone therapy that had sustained release by using
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`oligomers. So it's in that sense that he extended
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`Pawan.
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` Did that answer your question?
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` JUDGE VALEK: I think it did, but,
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`again -- this is Judge Valek -- that's not
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`really relevant to the claims here. Because the
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`claims aren't directed to oligomers.
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` MR. GALVIN: No, correct, Your Honor.
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`Again, this is Brian Galvin. It doesn't -- it's
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`not directly relevant to the claims. It is
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`relevant to a statement that Patent Owner makes,
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`which is that Martin does nothing but cite Pawan
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`and otherwise is irrelevant to our purposes.
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` But Pawan -- but Martin actually cites
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`Pawan for what Pawan found, and it predates the
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`filing of the Vlahakos patent, and he basically
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`states that it is known that BHB dietary
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`supplementation can be caused -- can be used for
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`appetite suppression and for reducing protein
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`catabolism. So in that sense, it's more than an
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`off-the-cuff citation, but also in his body of
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`Martin, he does talk about administering BHB and
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`various of its oligomers, so therefore it also
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`anticipates, because it does teach oral
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`administration of BHB for the purposes of weight
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`loss or prevention of weight gain, et cetera.
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` JUDGE VALEK: Go ahead.
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` MR. GALVIN: Okay. Moving on then. So
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`essentially, I want to talk now about the dosage
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`claims. Let's see here. I think I have actually
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`-- page 8 of my presentation, to sort of -- it's
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`from the decision to institute, and it is a few
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`more points that were brought out about Pawan, but
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`I've already discussed it and it's -- if BHB is
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`used as part of a weight control regime, that's
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`sufficient. It doesn't have to be the only thing
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`that is used. So the board also felt that reset
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`the institution, the point of institution, that
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`Pawan clearly anticipated Claims 1 and rendered 14
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`and 17 obvious. So we believe that continues to
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`be true.
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` To talk about dosage claims, at Claim 5,
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`is the one that has the minimum dose. And I'm
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`going to talk in terms of the -- sort of the
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`average adult dose, because it allows us to
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`compare references better. So if you recall in
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`Pawan, and I believe also in the Patent Owner's
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`response, the rule that you can -- the average
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`adult has 1.6 square meters of body surface area,
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`so you can convert readily between -- for
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`instance, 16 milligrams is equal to 96 milligrams
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`[sic] of total for an average adult.
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` So Claim 5 has a minimum dose of
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`96 milligrams per day for an average adult, and
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`Pawan teaches a dose of 18. One thing I wanted to
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`highlight also, when we start talking about doses,
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`is that Pawan was doing an experiment. Pawan
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`wasn't saying, This is the optimum dose for these
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`people. He was saying, These people are already
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`under a severe dietary restriction, either
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`starvation or severe energy restriction, for the
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`purpose of therapeutic rapid weight loss.
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` His experiment, what he determined, is
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`there a beneficial event by the administration of
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`BHB, so everyone got the same level, 18 grams. He
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`stated in his sort of background section, he
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`stated that it was known that you could orally
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`administer BHB in a solution with various
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`flavoring agents.
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` And so they also got the same dose, so you
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`have -- and because it's an experiment, you can
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`say everyone got 18 grams at various times as laid
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`out in the nice chart that's in the Patent Owner's
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`slides, but it's also in the text of Pawan. And
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`so it doesn't really talk about what are the
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`optimal doses, it just says we tested everyone at
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`18 grams.
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` So since the point of it is appetite
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`suppression, those people -- I still contend that
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`the argument that those people who are being
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`treated, were being treated for very rapid weight
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`loss under medical supervision, and so there was a
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`lot going on, and they did 18 grams to see if they
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`could see an effect. It would be obvious -- if I
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`just wanted to have a ketogenic diet and I wanted
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`to supplement, it would be obvious to use any
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`lower dose since BHB is referred to several places
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`in the record as being "generally safe." So it's
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`a nutrient. BHB is a nutrient, so I can take
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`less.
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` JUDGE VALEK: Counsel?
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` MR. GALVIN: Yes?
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` JUDGE VALEK: Counsel, this is
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`Judge Valek. So do you agree that neither Pawan
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`nor Martin disclose the administration of one of
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`these Markush compounds at a dosage that falls
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`within the range specified in Claim 6 and Claim 7.
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` MR. GALVIN: Yes. Yes, I do that.
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` JUDGE VALEK: So you've been talking about
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`how it would be obvious to lower that dose.
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`What evidence do you have, that's in the record,
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`that the dosage range in Claims 6 and 7 would have
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`been obvious?
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` MR. GALVIN: Well, there is no evidence in
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`the record for just Pawan teaching Claim 6 or
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`Claim 7. There is evidence with Neesby. So the
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`first argument is weak, let's leave it. You know,
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`it's in the record.
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` The more relevant argument is Neesby, and,
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`you know, the primary reason at the decision
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`institution that the board found that that
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`argument was unpersuasive, that Pawan and/or
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`Martin, but let's focus on Pawan, in view of
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`Neesby renders the 6 and 7 and their correlate
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`claims at 9, 12, and then 10 and 13, those claims
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`were -- there was no motivation to combine,
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`because Pawan -- Neesby was focused on allergy,
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`food allergy reduction.
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` And if you were to look at Pawan -- I mean
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`Neesby, carefully, it actually -- it has a few
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`case studies. I mean, it talks about appetite --
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`I mean allergy suppression, but it doesn't say
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`how. There's absolutely no mechanism. They just
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`say, We decided that we're going to provide BHB to
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`reduce food sensitivities.
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` And then there's a series of case studies
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`where it says this patient, one of which cited by
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`the Patent Owner, No. 4, I believe, had got his
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`desired weight gain, but the effect was to reduce
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`food sensitivities. But in several of those, they
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`were given BHB and antiallergy medicines, and
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`unsurprisingly, they had reduced allergy symptoms.
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`But one of them had migraines, and they got BHB;
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`and that eliminated their migraine symptoms and
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`they reported the general benefits of BHB to
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`include general mental wellness improvements.
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` So basically, in my view, Neesby is a lot
`
`like the Vlahakos patent in that there's no
`
`science behind it, but that's not really relevant
`
`for the purposes of evidence. For the purpose of
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`evidence, the general message of Neesby is that
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`taking BHB is good for you. It makes you feel
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`better. It can make migraines go away. It can
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`reduce your food sensitivities. No mechanisms are
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`discussed, so knowing that Neesby is out there, it
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`would be obvious to combine to try lower doses,
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`given that there were lower doses taught by
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`Neesby.
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` If I know that I'm going after the
`
`appetite suppressive effect, and the general other
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`benefits of protein catabolism reduction, and by
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`that time -- I mean, it's not in the record but,
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`you know, ketogenic diets were something that
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`people were pursuing in that time, it would be
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`obvious to combine Pawan and Neesby to teach the
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`dosages in Claim 6 and Claim 7. That Neesby does
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`teach those doses, I think, is uncontested, but
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`the reason for combining is the issue.
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` JUDGE VALEK: [Indiscernible.]
`
` MR. GALVIN: It's [indiscernible]
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`unlimited. Yeah, go ahead.
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` JUDGE VALEK: Sorry. I wanted to ask you
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`a question about that. This is Judge Valek again.
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` So the trouble I have with this argument,
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`I'll just be frank -- is there any evidence that
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`connects food allergy sensitivity to weight loss
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`or avoidance of weight gain? In other words, do
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`you --
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` MR. GALVIN: No.
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` JUDGE VALEK: -- it's obvious. Okay.
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` MR. GALVIN: No, but Neesby isn't really
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`about that. But I don't want to -- I actually
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`don't have a whole lot of time, and I believe the
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`argument with Pawan and Neesby actually holds up,
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`but I want to go further than that, and so I want
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`to do it while I have time.
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` So if he has lower doses, if you look at
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`page 11, it just shows that, in Claim 20, he
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`teaches 1 to about 2 grams. That fits comfortably
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`within the range of Claim 6 and Claim 7. So if
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`it's any reason to combine, Neesby and Pawan would
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`render them obvious.
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` But if you go back to my timeline
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`discussion from the very beginning, so that was
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`all based on the petition, and up to that point,
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`once the petition is in, Petitioner is master of
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`its petition, but Petitioner is severely
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`restrained from that point forward about
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`introducing any evidence or arguments. I can only
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`-- Petitioner can only respond to actions taken by
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`the Patent Owner.
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` So the Patent Owner filed, in February of
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`this year, a motion to amend, and that actually
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`puts the Patent Owner in charge of the scope,
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`because the Patent Owner is the master of his
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`motion to amend. And by filing a motion to amend,
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`some of the claims in which were exactly
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`coextensive in scope with claims that are in the
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`'356 patent, he opened the door to dealing with
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`101 and 112 issues which were addressed in the
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`Petitioner's reply.
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` And in the same way that the Petitioner is
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`master of his petition and that 311 limits the
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`scope to the petition to 102 and 103, the Patent
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`Owner is master of its motion to amend, of its
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`amendments under 316.
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` And since I have limited time before I go
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`out, I want to talk about the cases that I
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`mentioned.
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` So if you --
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` JUDGE VALEK: Counsel, this is
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`Judge Valek. The motion to amend has been
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`withdrawn, correct?
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` MR. GALVIN: Yes.
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` JUDGE VALEK: All right. So we're not
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`being asked to assess the patentability of any
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`proposed substitute claims involved?
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` MR. GALVIN: No, no new claims. Under
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`Section 318, you're being -- what you're going to
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`be doing after this hearing is assessing the
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`patentability of any claims remaining at issue,
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`which are all the original claims, and you'll be
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`assessing it based on a totality of the record.
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