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`UNITED STATES PATENT AND TRADEMARK OFFICE
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
` ____________________________
` GEA PROCESS ENGINEERING, INC.
` Petitioner
` v.
` STEUBEN FOODS, INC.
` Patent Owner
` _____________________________
`
` Case IPR2014-00041
` U.S. Patent No. 6,945,013
` Case IPR2014-00043
` U.S. Patent No. 6,475,435
` Case IPR2014-00051
` U.S. Patent No. 6,209,591
` Case IPR2014-00054
` U.S. Patent No. 6,481,468
` Case IPR2014-00055
` U.S. Patent No. 6,537,188
` _____________________________
`
` DEPOSITION OF SUDHIR K. SASTRY
` Volume 2
` Alexandria, Virginia
` June 26, 2014
`
`Reported by: Mary Ann Payonk / Job No. 80914
`
`TSG Reporting - Worldwide 877-702-9580
`
`IPR2014-00055
`Steuben Exhibit 2069, pg. 1
`
`

`
`Page 228
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` June 26, 2014
` 9:00 a.m.
`
` Deposition of SUDHIR K. SASTRY, Volume
`2, held at the offices of Oblon Spivak, 1940
`Duke Street, Alexandria, Virginia, pursuant to
`Notice before Mary Ann Payonk, Nationally
`Certified Realtime Reporter and Notary Public
`of the District of Columbia, Commonwealth of
`Virginia, States of Maryland and New York.
`
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`Steuben Exhibit 2069, pg. 2
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`APPEARANCES:
`ON BEHALF OF PETITIONER:
` BENJAMIN KIERSZ, ESQUIRE
` WILLIAM ATKINS, ESQUIRE
` MICHAEL HEINS, ESQUIRE
` PILLSBURY WINTHROP SHAW PITTMAN
` 1650 Tysons Boulevard
` McLean, VA 22102
`
`ON BEHALF OF PATENT OWNER:
` GREG GARDELLA, ESQUIRE
` KEVIN LAURENCE, ESQUIRE
` OBLON SPIVAK McCLELLAND MAIER & NEUSTADT
` 1940 Duke Street
` Arlington, VA 22314
`
`ALSO PRESENT:
` Cook Alciati, Esquire
` Corporate Counsel, Steuben
` Charles M. Avigliano, Esquire
` Corporate Counsel, Steuben
` Jordan Mummert, Legal Video Specialist
`
`TSG Reporting - Worldwide 877-702-9580
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`IPR2014-00055
`Steuben Exhibit 2069, pg. 3
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`

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` S. Sastry
` THE VIDEOGRAPHER: This is the start
` of the continuation of the videotaped
` deposition of Sudhir Sastry in the matter
` GEA Process Engineering versus Steuben
` Foods. The date is June 26, 2014. The
` time is approximately 9:03 a.m. We are on
` the record.
`SUDHIR K. SASTRY,
` recalled as a witness, having been duly
` sworn, was examined and testified as
` follows:
` EXAMINATION (Cont'd.)
`BY MR. KIERSZ:
` Q. Dr. Sastry, between when we ended the
`deposition yesterday and now, did you speak with
`any counsel about the substance of your
`deposition testimony?
` A. No.
` Q. Did you speak with counsel about
`anything about how to answer any deposition
`questions?
` A. No.
` Q. Can I have you turn in your
`declaration in IPR2014-00053. It will be in one
`
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`IPR2014-00055
`Steuben Exhibit 2069, pg. 4
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`of the binders, or 55.
` A. No, it's 55 is the one --
` Q. Yeah, 55's the one I'm looking for.
`If I can ask you to turn to page 21.
` A. 21. Yes.
` Q. And at the top of page 21, you cite an
`Exhibit 2021. What is that exhibit?
` A. That is the Ocasio reference.
` Q. I believe you have that exhibit in --
` A. It should be here.
` Q. In this one here. I believe it's
`going to be in the exhibit binder I've already
`handed to counsel. Could I ask you to turn to
`that Exhibit 2021, and specifically to page 24.
` (Discussion held off the record.)
`BY MR. KIERSZ:
` Q. Are you on page 24 of Exhibit 2021?
` A. One moment. Page 24.
` Q. Correct.
` A. Yes.
` Q. Do you see the second sort of arrow
`bullet point that says "performance criteria
`equals 12-log reduction of C bot"?
` A. Uh-huh.
`
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`Steuben Exhibit 2069, pg. 5
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` Q. Does that sentence refer to the 12D
`concept for sterilization?
` A. Yes, yes.
` Q. Now can you turn to page 35 of the
`same exhibit, 2021. I'm sorry. Page 34 is what
`I'm referring to.
` A. Uh-huh.
` Q. Do you see the last line on page 34 of
`Exhibit 2021 states that "4 equals performance
`criteria"?
` A. Uh-huh, uh-huh.
` Q. Do you agree that that page states the
`performance criteria for B. cereus is a 4-log
`reduction of B. cereus?
` A. This would be in the -- okay, now
`let's maybe refer to -- to start with, I will
`say yes, but then I want to also note that this
`is of course a later date, and so these criteria
`are later than is -- probably date to the early
`2000s.
` Q. Okay. So in the early 2000s the
`performance criteria for commercial sterility
`using peroxyacetic acid and B. cereus was 4-log
`in the 2000s?
`
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`IPR2014-00055
`Steuben Exhibit 2069, pg. 6
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` A. Well, maybe a little more note of
`clarification. Back many years ago, the normal
`approach of most processing specialists used to
`be to go with the 10-, the 12-log reduction.
`And somewhere around 2000 or thereabouts, FDA
`started modifying its procedures for a process
`filing from going from a very -- what used to
`be -- people used to ask them why do you do a
`12-log, and they said we don't exactly do it.
`They started going to a more risk
`assessment-based methodology. And so they came
`up with this food safety objective, which is --
`if you look at Ocasio's page 24, he talks about
`FSO, and the FSO is based on a food safety
`objective. So this is a new approach that FDA
`has for validating processes.
` And so that change came about I would
`say subsequent to the date of -- that we're
`talking about here in 1999.
` Q. So going back to page 24 --
` A. Yes.
` Q. -- that -- do you understand that this
`12D concept is still being applied to
`C. botulinum?
`
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` A. Okay. Just a little note there as
`well. One -- talking to FDA, oftentimes one
`gets the response that we never actually
`required it. Now, that is because they want the
`processor to show them that they have a sterile
`product. Really, to show them, demonstrate
`proof that you have absence of pathogenic
`organisms that might grow under normal
`conditions may be obtained by many different
`ways. And they acknowledge that.
` But however, many processing
`specialists have historically used the 12-log
`criteria. And so their feeling is that given
`the amount of time required to show sterility by
`alternative means, the safest way or the fastest
`way through the FDA is to show a 12-log, which
`was the old criterion.
` So there is not one path that has
`been -- and today FDA is much more flexible in
`this regard, as long as the food safety
`objective is met and the processor shows that
`they are able to achieve that objective.
` Q. So the FDA no longer uses -- requires
`a 12D proof for Clostridium botulinum?
`
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`IPR2014-00055
`Steuben Exhibit 2069, pg. 8
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` A. They do not require it per se, but
`they will accept it if provided.
` Q. What is the basis of your knowledge
`about these new approaches?
` A. Numerous conferences.
` Q. So is it your opinion that right now,
`a company could obtain FDA approval for a
`low-acid aseptic machine without demonstrating a
`12-log reduction of Clostridium botulinum?
` A. If you can show by other means, by
`looking at a full risk assessment, that you
`could demonstrate convincingly that you do not
`have spore formers that could possibly grow in
`the food under normal conditions of storage.
` Now, let me maybe also point out that
`this is quite an onerous task, and most
`companies shy away from this task because it is
`so onerous because FDA may come back and say you
`need to give me more evidence. So there's a lot
`of evidence and -- gathering in the process.
` Q. So it's easier just to show a 12-log
`reduction in C. bot than to use another criteria
`for demonstrating commercial sterility?
` A. Yes.
`
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`IPR2014-00055
`Steuben Exhibit 2069, pg. 9
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` S. Sastry
` Q. Can we go back to page 35 now?
` A. Yes.
` Q. Or 34. In this document, is the
`author of this document submitting that a 4-log
`reduction in B. cereus is sufficient to
`demonstrate commercial sterility when Oxonia is
`used as a sterilant?
` A. Yeah, he is saying that with all the
`qualifications there and obtaining all those --
`that information and providing that to the FDA.
`Now, FDA may choose to accept it or not accept
`it, depending on what -- you know, how they
`perceive the processor, you know, the
`processor's capability is, what their scientific
`approaches they're using and the evidence,
`really based on science.
` Q. Is this author submitting that a proof
`of a 4-log reduction in B. cereus when Oxonia is
`used as a sterilant will satisfy the FDA's
`regulations for a low-acid aseptic packaging
`system?
` MR. GARDELLA: Objection, foundation.
` A. This document is intended to be a
`presentation, and in fact, I don't recall, I may
`
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`IPR2014-00055
`Steuben Exhibit 2069, pg. 10
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`or may not have been at that particular meeting,
`but he was -- he's presenting it to people
`showing them the alternative pathway that one
`might use, conceivably use towards a process
`filing. There are no guarantees with FDA
`processes. There are no guarantees that -- I
`don't believe he's providing a guarantee here,
`but he's providing an example of a way a
`processor might use the food safety objective to
`come to a end point.
` Q. Is it this author's belief that a
`4-log reduction in B. cereus is sufficient to
`satisfy commercial sterility?
` A. I cannot speak for that author's
`motivation.
` Q. Is that what he's -- this author is
`asserting in this document?
` A. I don't believe he's asserting. I
`think he's demonstrating to people that there
`are ways to use this.
` Q. What does the FDA require as a log
`reduction if Oxonia is used as a bottle or as a
`container sterilant?
` A. Okay. This goes back to the same sort
`
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`of -- the same theme I've been talking about.
`FDA, when approached, oftentimes will not tell
`you. They will ask you to come and tell me and
`convince me, okay, speaking as them. And it's
`up to the company to provide the evidence, upon
`which FDA may come back to them and say, I need
`more evidence. And where's the science?
` So there may be a lot of question,
`answer, and interplay before a process is
`actually filed with the FDA. So there is not
`one thing. And I -- you know, this is what I've
`heard from FDA over several years is that they
`don't want a one-size-fits-all approach for
`process filing, but rather the demonstration
`that the processor knows what they're doing is
`the most important thing, knows what they're
`doing and knows what the criteria are is more
`important to FDA.
` Q. On February 2 of 1999, would a POSITA
`understand what level of sterilization had to be
`achieved when using Oxonia to sterilize a food
`container in order to satisfy the FDA, prove the
`FDA level of sterilization?
` A. Yeah, this is a hard question to
`
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`IPR2014-00055
`Steuben Exhibit 2069, pg. 12
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`answer, partly because FDA has always had this
`approach of you need to come to me with a
`process filing and give me more evidence. Okay?
`So a POSITA could have come back with -- and
`said here is a Oxonia process filing, and the
`FDA could have responded, give me more evidence,
`you know, what's the most -- and FDA will make
`their decision on the basis of science.
` And at the time, the Blackistone
`reference existed which showed that Bacillus
`cereus was of concern. So the question probably
`would have come up, what is the surrogate
`organism.
` Now, I'm not in a position to say what
`the surrogate organism is or should have been
`for Bacillus cereus, but I think that would have
`been an ongoing discussion at that point on what
`would have trans- -- need to have transpired in
`order for a process filing to take place.
` I don't think at that -- what has
`happened -- and maybe a little bit more
`background is in order here -- is that through
`the 1990s or so, there's been an explosion in
`different types of methods in sterilization that
`
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`IPR2014-00055
`Steuben Exhibit 2069, pg. 13
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`are used, and a number of companies have been
`coming to FDA with all kinds of questions.
` So FDA, around 2000, actually
`contracted to get some information on
`inactivation. And right about then, they came
`up with the -- this whole different approach of
`how one assesses and how one goes about doing
`this.
` So I'm talking about a period of time
`where there's a lot of changes taking place, and
`so it's very hard to pinpoint a very exact
`number for that particular point in time.
` Q. Yes or no? Would a POSITA on
`February 2 of 1999 have known what degree of
`sterilization was required to satisfy the FDA
`for aseptic sterilization of a bottle --
` MR. GARDELLA: Objection to form.
` Q. -- using peroxyacetic acid and
`hydrogen peroxide?
` MR. GARDELLA: Same objection.
` A. This is not a question that I can
`answer for the reason that the complexities of
`the situation I just described to you were such
`that a POSITA could not have made a quick
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`judgment and said I would -- this will pass FDA
`muster.
` Q. So do you agree that a POSITA would
`not have known whether or not they could pass
`FDA muster with a certain log reduction when
`using a combination of hydrogen peroxide and
`peroxyacetic acid as a sterilant on a container?
` MR. GARDELLA: Objection, asked and
` answered.
` A. They may not have known, but they
`possibly could have started the interactive
`process of getting there.
` Q. Can I have you turn in the '188 patent
`to Claim 40?
` A. Certainly, certainly.
` Q. Leave that open because I'm going to
`continue to refer to that, if you can.
` A. Okay. This one was?
` Q. 2021.
` A. Yes. Now we're looking at the '188
`patent.
` Q. Yes. Can you look at Claim 40, which
`is on the last page?
` A. Certainly.
`
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` Q. Do you see that the second clause
`requires aseptically disinfecting the plurality
`of bottles to a level producing at least a 6-log
`reduction in spore organisms?
` A. Uh-huh, yes.
` Q. And then do you also see in the final
`clause, sort of the middle of the last wherein
`clause states that "the sterilant is
`peroxyacetic acid and hydrogen peroxide"?
` A. Yes.
` Q. Going back to the term in the second
`clause, "aseptically disinfecting."
` A. Yes.
` Q. Do you agree that aseptic disinfecting
`is aseptic disinfecting using hydrogen peroxide
`and peroxyacetic acid?
` A. It says, "aseptically disinfecting the
`plurality of bottles to a level producing at
`least a 6-log reduction in spore organisms."
`And at this point in the statement there's
`nothing to state what the sterilant is. And
`then later on it's qualified saying wherein the
`step is -- "further includes a measuring device
`for measuring quantity" where -- "and wherein
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`the sterilant is." So one might conceivably see
`this as it includes this, a measuring device,
`and so it -- it could include such a thing, but
`maybe not.
` Q. Okay. Would a POSITA understand that
`Claim 40 requires the aseptic disinfection of
`the plurality of bottles to be using
`peroxyacetic acid and hydrogen peroxide as the
`sterilant?
` A. POSITA might have seen that, but in --
`I mean, I think it says you might use
`peroxyacetic acid and hydrogen peroxide, but,
`you know, possibly not.
` Q. You're here today to testify about
`what a POSITA would have understood; correct?
` A. Yes, yeah.
` MR. GARDELLA: Objection, foundation.
` Q. And in your declaration, you've stated
`you understand the claims; correct?
` A. Yes.
` Q. I'm asking you whether a POSITA
`looking at Claim 40 would believe that the
`aseptic disinfection of the plurality of the
`bottles is required to be through the use of
`
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`peroxyacetic acid and hydrogen peroxide.
` MR. GARDELLA: Objection, scope,
` relevance.
` A. Well, a POSITA could have looked at
`this and understood it to mean aseptically
`disinfecting, but not necessarily restricted to
`that particular sterilant.
` Q. All right. So Claim 40 does not
`require that the aseptically disinfecting the
`plurality of bottles is done with hydrogen
`peroxide and peroxyacetic acid?
` MR. GARDELLA: Same objections.
` A. So it would seem.
` Q. So would ZFL's use of hydrogen
`peroxide to aseptically disinfect bottles fall
`within the scope of Claim 40's aseptically
`disinfecting bottles limitation?
` A. This is going to require a little bit
`of consideration and perhaps if you could repeat
`the question, it will help me a little.
` Q. Would ZFL's use of hydrogen peroxide
`to aseptically disinfect bottles be covered by
`Claim 40 even if ZFL does not use peroxyacetic
`acid as the sterilant for the bottles?
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` A. May I refer to ZFL?
` Q. Please.
` A. Okay. Okay, let's see.
` Appreciate another repetition of the
`question.
` (The reporter read from the record as
` follows: Would ZFL's use of hydrogen
` peroxide to aseptically disinfect bottles
` be covered by Claim 40 even if ZFL does
` not use peroxyacetic acid as the sterilant
` for the bottles?)
` A. Would ZFL's claim, or ZFL's use of
`hydrogen peroxide be covered by Claim 40 even if
`ZFL does not use peroxyacetic acid?
` MR. GARDELLA: Objection to
` foundation.
` A. It's kind of a convoluted question
`that's going to take me a little time to assess.
`Probably the best assessment I can make at this
`point is I don't feel qualified to answer that
`question.
` Q. Why aren't you qualified to answer
`that question?
` A. Because it enters a realm of legal
`
`TSG Reporting - Worldwide 877-702-9580
`
`IPR2014-00055
`Steuben Exhibit 2069, pg. 19
`
`

`
`Page 246
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` S. Sastry
`language about which I'm not -- I don't feel I'm
`qualified as an expert in that area.
` Q. Because you don't understand the scope
`of Claim 40?
` MR. GARDELLA: Objection, asked and
` answered.
` A. I understand the scope of Claim 40,
`but the introduction of the other materials with
`ZFL and so on requires me to make a judgment
`that I am unable to make within a short period
`of time, and perhaps involves expertise that I
`don't possess.
` Q. And those expertise are expertise in
`understanding what claim language means?
` A. Perhaps. And perhaps the details and
`subtleties of ZFL's documentation, the details
`and subtleties of the claim language and -- that
`requires me to make judgments about which I'm
`unable to come up with a quick answer.
` Q. What judgments would you have to make
`in order to answer the question?
` A. I would need time and due
`consideration of what that is and what it means
`and I would have to review the question multiple
`
`TSG Reporting - Worldwide 877-702-9580
`
`IPR2014-00055
`Steuben Exhibit 2069, pg. 20
`
`

`
`Page 247
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`times, probably.
` Q. What judgments can't you make quickly?
`What assessment?
` A. Well, the --
` MR. GARDELLA: Objection, asked and
` answered.
` A. I believe I just answered that. Those
`are the judgments I cannot make.
` Q. You have not told me what judgments
`you're referring to.
` A. The judgments I cannot make are with
`regard to --
` MR. GARDELLA: Same objection. I'll
` permit this to go on for another question
` or two, counsel, but I think the witness
` has clearly stated his comfort level and
` his ability, so it appears that these
` questions are badgering, but I'll give you
` some leeway. Just be on notice.
` MR. KIERSZ: He has yet to tell me
` what judgments it would take additional
` time to make. He just said that there are
` judgments that would take more time. I'd
` like to know what those judgments are.
`
`TSG Reporting - Worldwide 877-702-9580
`
`IPR2014-00055
`Steuben Exhibit 2069, pg. 21
`
`

`
`Page 248
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` Q. What analysis can you not do right
`now?
` MR. GARDELLA: I have a response to
` that, but it wouldn't be appropriate for
` me to make that response in the presence
` of the witness. So I'll give you another
` question or so, but then we will have a
` discussion off the record.
` A. First off, it would entail my review
`of the ZFL to actually figure out what position
`I need to take on, you know, on the question of
`what ZFL's use is. Thereafter, I would need to
`look at Claim 40 in substantial detail to see
`what might possibly be covered or not covered.
`And then to your later part of the question,
`with ZFL's nonuse of the peroxyacetic
`acid/hydrogen peroxide combination, I would need
`to do a cycle of reasoning with that as well
`before I could come to some degree and some
`level of comfort of my answer.
` Q. Let me take ZFL out of the equation
`and go back to just Claim 40. Do you understand
`what Claim 40 means?
` A. Yes.
`
`TSG Reporting - Worldwide 877-702-9580
`
`IPR2014-00055
`Steuben Exhibit 2069, pg. 22
`
`

`
`Page 249
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` Q. Does Claim 40 require the use of
`peroxyacetic acid to sterilize bottles?
` MR. GARDELLA: Objection, scope,
` relevance.
` A. I believe I mentioned that it might or
`it might not.
` Q. Can you turn in your declaration to --
`this is the declaration in IPR2014-00055.
` A. One moment. IPR2014-00055. Okay. My
`declaration, yeah.
` Q. Keep the patent open because I'm going
`to continue referring to Claim 40 of the patent.
` A. Certainly. Hang on just a moment.
` Q. Can you turn to paragraph 15 in your
`declaration, 2024 in IPR2014-00055?
` A. You said paragraph 15?
` Q. Correct.
` A. One moment.
` Uh-huh.
` Q. In paragraph 15, do you declare that
`you have read and understand the Taggart
`patents, including their claims?
` A. Yes, I do. Yes, I have.
` Q. Now, with reference to Claim 40, do
`
`TSG Reporting - Worldwide 877-702-9580
`
`IPR2014-00055
`Steuben Exhibit 2069, pg. 23
`
`

`
`Page 250
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`you know, based on your understanding of Claim
`40, whether Claim 40 requires the use of
`peroxyacetic acid to sterilize the bottles -- to
`aseptically disinfect bottles?
` MR. GARDELLA: Objection, scope,
` relevance.
` A. '188, Claim 40.
` Q. Correct.
` A. Well, as I see it here, there's a
`method for aseptically bottling aseptically
`sterilized foodstuffs comprising the steps of:
`providing a plurality of bottles, aseptically
`disinfecting the plurality of bottles to a level
`producing at least a 6-log reduction in spore
`organisms, filling the aseptically disinfected
`plurality of bottles with the aseptically
`sterilized foodstuffs, and filling the
`aseptically disinfected plurality of bottles at
`a rate greater than 100 bottles per minute. So
`up to this point, there's nothing about the
`sterilant.
` Then it says, "wherein the step of
`aseptically disinfecting the plurality of
`bottles further includes" -- meaning that it
`
`TSG Reporting - Worldwide 877-702-9580
`
`IPR2014-00055
`Steuben Exhibit 2069, pg. 24
`
`

`
`Page 251
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` S. Sastry
`maybe further includes, maybe not -- "a
`measuring device for measuring a quantity of
`sterilant, and wherein the sterilant is
`peroxyacetic acid and hydrogen peroxide; and
`wherein the peroxyacetic acid and hydrogen
`peroxide uses a concentration sensor to ensure
`that the concentration of the peroxyacetic acid
`and hydrogen peroxide is maintained at a
`predetermined level."
` So there's the broader part of it, and
`then you can further include a device. So I
`would tend to see that as possibly including it
`and possibly not.
` Q. Does it -- based on your
`understanding, does Claim 40 or does Claim 40
`not require that the aseptic disinfecting be
`done with the use of hydrogen peroxide and
`peroxyacetic acid?
` MR. GARDELLA: Objection, relevance,
` scope, asked and answered multiple times.
` Q. Are you unable to answer the question?
` MR. GARDELLA: Same objections.
` A. It's as I've said. It includes it.
`Maybe the scope, the overall scope doesn't say
`
`TSG Reporting - Worldwide 877-702-9580
`
`IPR2014-00055
`Steuben Exhibit 2069, pg. 25
`
`

`
`Page 252
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` S. Sastry
`what sterilant, but in the -- in the -- when it
`goes to wherein, you include it. So it's
`included but it's -- is it necessary? I mean,
`is it? Is it -- you know, it's -- it could be
`one of other things. It could be a sterilant.
` Q. What's your understanding? Is
`peroxyacetic acid and hydrogen peroxide required
`in the -- to be used in aseptically disinfecting
`the bottles, or is it not required? Yes or no?
` MR. GARDELLA: Same objections, asked
` and answered multiple times.
` A. It includes it, which means it could
`or could not.
` Q. Is it ambiguous?
` MR. GARDELLA: Same objections.
` A. It says there's a choice, perhaps you
`don't -- perhaps you include it, perhaps you
`don't.
` Q. Okay. So the use of peroxyacetic acid
`and hydrogen peroxide is optional in Claim 40
`for sterilizing the bottles?
` A. I would read it as that.
` Q. What do you mean by "optional"?
` MR. GARDELLA: Same objections.
`
`TSG Reporting - Worldwide 877-702-9580
`
`IPR2014-00055
`Steuben Exhibit 2069, pg. 26
`
`

`
`Page 253
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` S. Sastry
` A. You have a sterilant that you're using
`and then possibly, you know, which sterilant,
`you know, one of them may be peroxyacetic acid
`and hydrogen peroxide, but maybe not.
` Q. Could a process fall within the scope
`of Claim 40 even if peroxyacetic acid was not
`being used to aseptically disinfect bottles?
` MR. GARDELLA: Same objections, asked
` and answered.
` A. I believe it could, because there is
`the option of not using it.
` Q. Do you understand Claim 40 to require
`that the aseptic disinfecting be done with a
`sterilant?
` A. Yes.
` Q. And do you understand that Claim 40
`says that "the sterilant is peroxyacetic acid
`and hydrogen peroxide"?
` A. Yes, on some level it is, but it seems
`like an inclusion at the end, where it further
`includes.
` Q. So on what level?
` A. On that you have all the first three
`statements, providing a plurality, aseptically
`
`TSG Reporting - Worldwide 877-702-9580
`
`IPR2014-00055
`Steuben Exhibit 2069, pg. 27
`
`

`
`Page 254
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`disinfecting the plurality of bottles, filling
`the aseptically disinfected plurality of
`bottles, filling them at a rate greater than 100
`bottles a minute, and then it says wherein the
`step further includes. So it could include it,
`maybe not.
` Q. So the claim doesn't require it to be
`included?
` A. Does not require it to be included.
`That's my reading of it.
` Q. The claim does not require that the
`sterilant used to aseptically disinfect the
`bottles be peroxyacetic acid and hydrogen
`peroxide, is your testimony?
` A. That's my -- that's my understanding
`there.
` Q. Is it your understanding that the term
`"aseptically disinfecting" in Claim 40 requires
`aseptically disinfecting to the FDA's level of
`aseptic?
` A. I would -- yes, I would understand it
`to mean that.
` Q. And in the context of Claim 40, what
`is the FDA's level of aseptic?
`
`TSG Reporting - Worldwide 877-702-9580
`
`IPR2014-00055
`Steuben Exhibit 2069, pg. 28
`
`

`
`Page 255
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` A. In the context of Claim 40, it would
`appear that the FDA level of aseptic would be
`the 6-log reduction in spore organisms.
` Q. And what spore organisms?
` A. This would be the spore organisms of
`greatest concern, or the surrogate spore
`organism that would be of the greatest concern
`in the -- for the particular sterilant you use.
` Q. So it's 6-log of -- of any spore
`organism or --
` A. If it was, for example, hydrogen
`peroxide, Bacillus subtilis would be the
`commonly used spore organism. If it was not, it
`would be some other spore organism or its
`surrogate.
` Q. Assume for a minute that the aseptic
`disinfecting is done with a combination of
`hydrogen peroxide and peroxyacetic acid. What
`would be required to demonstrate the FDA level
`of aseptic?
` A. I think it is worth asking a further
`question here, is the ratio of concentrations of
`hydrogen peroxide and peroxyacetic acid. This
`is not spelled out here. And in principle, one
`
`TSG Reporting - Worldwide 877-702-9580
`
`IPR2014-00055
`Steuben Exhibit 2069, pg. 29
`
`

`
`Page 256
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`could say the mixture is zero percent
`peroxyacetic acid, 100 percent hydrogen
`peroxide. Or the other way around. Or
`something in between. So it's all those
`combinations. My reading of this, all those are
`possible here. And so one of the questions
`there might be what is the concentration ratio?
` Q. Are you saying that it's possible to
`carry out the method of Claim 40 by using a zero
`percent peroxyacetic acid concentration?
` A. Yes, it's possible, because then you'd
`be left with hydrogen per

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