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`Transcript of James Agalloco
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`Date: May 4, 2022
`Case: Regeneron -v- Novartis (PTAB)
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`Planet Depos
`Phone: 888.433.3767
`Email: transcripts@planetdepos.com
`www.planetdepos.com
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`WORLDWIDE COURT REPORTING & LITIGATION TECHNOLOGY
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`Novartis Exhibit 2339.001
`Regeneron v. Novartis, IPR2021-00816
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`REDACTED VERSION
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`

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`Transcript of James Agalloco
`Conducted on May 4, 2022
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`A P P E A R A N C E S:
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`ON BEHALF OF PETITIONER REGENERON PHARMACEUTICALS,
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`INC.:
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` Natalie Kennedy, Esquire
` Weil, Gotshal & Manges LLP
` 767 Fifth Avenue
` New York, New York 10153-0119
` PHONE: +1 (212) 310-8730
` E-MAIL: Natalie.Kennedy@weil.com
` -and-
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` Andrew Peter Gesior, Esquire
` Weil, Gotshal & Manges LLP
` 767 Fifth Avenue
` New York, New York 10153-0119
` PHONE: +1 (212) 310-8244
` E-MAIL:andrew.gesior@weil.com
` -and-
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` Christopher Pepe, Esquire
` Weil, Gotshal & Manges LLP
` 2001 M Street, NW
` Washington, D.C. 20036
` PHONE: +1 (202) 682 7153
` E-MAIL: Christopher.pepe@weil.com
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` UNITED STATES PATENT AND TRADEMARK OFFICE
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` ___________________________
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` BEFORE THE PATENT TRIAL AND APPEAL BOARD
` __________________________
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` REGENERON PHARMACEUTICALS, INC.,
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` Petitioner
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` v.
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` NOVARTIS PHARMA AG,
` NOVARTIS TECHNOLOGY LLC,
` NOVARTIS PHARMACEUTICALS CORPORATION,
` Patent Owners
` ____________________________
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` Case IPR2021-00816
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` Patent No. 9,220,631
` ___________________________
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` Remote Zoom Deposition of
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` JAMES AGALLOCO, taken on
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` May 4, 2022 at 10:02 a.m.
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` ____________________________
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`Job No. 447979
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`Pages 1-139
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`Reported by: Lisa M. Barrett, RPR, CRR, CRC, CSR
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` REMOTE DEPOSITION OF JAMES AGALLOCO held
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`A P P E A R A N C E S (CONT'D)
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`(Via Zoom Videoconferencing):
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`ON BEHALF OF PETITIONER REGENERON PHARMACEUTICALS,
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`INC.:
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` Petra Scamborova, PhD, JD
` Regeneron Pharmaceuticals, Inc.
` 777 Old Saw Mill River Road
` Tarrytown, New York 10591
` PHONE: +1 (914) 847-7611
` E-MAIL: Petra.scamborova@regeneron.com
`
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`ON BEHALF OF THE PATENT OWNERS:
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` Elizabeth J. Holland, Esquire
` Allen & Overy LLP
` 1221 Avenue of the Americas
` New York, New York 10020
` PHONE: +1 (212) 610 6365
` E-MAIL: Elizabeth.Holland@allenovery.com
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` Before Lisa M Barrett, Certified Relatime
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`Court Reporter Reporter, and Notary Public of the State of
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`Maryland.
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`PLANET DEPOS
`888.433.3767 | WWW.PLANETDEPOS.COM
`
`Novartis Exhibit 2339.002
`Regeneron v. Novartis, IPR2021-00816
`
`REDACTED VERSION
`
`

`

`Transcript of James Agalloco
`Conducted on May 4, 2022
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` "Sterilization of health
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` care products-Requirements
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` and for selecting a
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` sterility - assurance level
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` (SAL) for products labeled
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` "sterile" Novartis.
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`Exhibit 2206 Document entitled, "Dr. Sigg's 79
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` declaration."
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`Exhibit 2115
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`Exhibit 2104 Document reflecting 105
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` C O N T E N T S
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`EXAMINATION OF JAMES AGALLOCO PAGE
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`By Ms. Holland 9
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` E X H I B I T S
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` (Presented pre-marked exhibits)
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` (Attached to the Transcript)
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`Exhibit 1016 Excerpt from a book 9
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` called "Pharmaceutical Dosage
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` Forms," edited by Nema and
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`Exhibit 1100 Expert Declaration by James 16
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` Agalloco
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`Exhibit 2330 Transcript of James Agalloco 19
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` dated February 16, 2021
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` Case: Certain Pre-Filled
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` Syringes for Intravitreal
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` communications between
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` Injection (337-TA-1207)
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`Exhibit 1029 Patent Application, Xanthe 115
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` Wednesday, May 4, 2022
`--- Commencing at 10:02 a.m.
` REMOTE TECHNICIAN: Before we
`administer the oath, I just have a brief read on
`script to do for Planet Depos. One second, let me
`pull that up. Thank you to everyone for attending
`this proceeding remotely, which we anticipate will
`run smoothly. Please remember to speak slowly and
`do your best not to talk over one another.
` Please be aware we are recording this
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`proceeding for backup purposes. Any
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`off-the-record discussions should be had away from
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`the computer. Please remember to mute your mic
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`for those conversations.
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`the reporter identify who is speaking. If you are
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`unable to connect with video and are connecting
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`via phone, please identify yourself each time
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` I apologize in advance for any
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`technical-related interruptions. Thank you.
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` (Court reporter read oath stipulation.
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`PLANET DEPOS
`888.433.3767 | WWW.PLANETDEPOS.COM
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` E X H I B I T S
` PAGE
` (Presented pre-marked exhibits)
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` (Attached to the Transcript)
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`Exhibit 2328 Article co-authored by James 20
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` Agalloco with Dr. Aikers,
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` published in 2013.
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`Exhibit 1007 Document entitled "Sigg 36
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` Publication."
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`Exhibit 1005 Document from IPR 317. 39
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`Exhibit 2148 Technical memorandum from 41
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`Exhibit 2329 Document entitled, 53
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` "Pharmaceutical Manufacturing
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` Handbook: Production and
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` Processes."
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` E X H I B I T S (Continued)
` PAGE
` (Presented pre-marked exhibits)
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` (Attached to the Transcript)
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`Exhibit 2187 Document entitled: 67
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`Novartis Exhibit 2339.003
`Regeneron v. Novartis, IPR2021-00816
`
`REDACTED VERSION
`
`

`

`Transcript of James Agalloco
`Conducted on May 4, 2022
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` Counsel agreed.)
` JAMES AGALLOCO, having been duly
` sworn testified as follows,
` EXAMINATION
`BY MS. HOLLAND:
` Q Good morning, Mr. Agalloco, nice to see
`you again.
` A Good morning.
` Q I'd like to start by looking at exhibit
`1016.
` (Whereupon, Exhibit 1016 was
`identified.)
`BY MS. HOLLAND:
` Q So Matt, can you put that up on the
`screen please. Can you -- thank you.
` Mr. Agalloco, this is an excerpt from a
`book called "Pharmaceutical Dosage Forms," edited
`by Nema and Ludwig.
` You are familiar with this reference,
`correct?
` A Yes, I am.
` Q And you wrote one of the chapters in
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`it"?
` A It can be written differently, but I
`agree with it in principle.
` Q And then I want to look at the next
`paragraph, the first sentence, which says that:
` "Requirements for the validation and routine
`operation of sterilization methods are given in a
`series of ISO and AAMI standards and guidelines."
`[As read.]
` Do you see that?
` A Yes, I do.
` Q And do you agree with that as well?
` A That is only correct within the medical
`device industry.
` The ISO standard are, you know, widely
`accepted in that industry, which is the one that
`AAMI represents.
` The drug industry tends to follow the
`standards of the Food and Drug Administration.
` They look at these, but they do not
`follow them exactly.
` Q Do you -- let me withdraw that.
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` Are you familiar with the AAMI
`here, right?
` A That's correct.
`standards?
` A Only to the extent that I work with a
` Q Can we go to page 1016.210. Thank you.
`device, but when I'm working with drugs, I look
` Mr. Agalloco, this is a chapter in the
`more closely at Food and Drug Administration
`Exhibit 1016, the Nema book, called:
`expectations.
` "Industrial Sterilization Techniques:
` Q Okay, is a syringe a device?
`Principles and Overview" by Anne Booth.
` A When it is presented with a drug inside
` Have you seen this before?
`of it, it is a drug.
` A Only in passing. I have not read it in
`depth.
` Q Let me turn now to page 1016.256.
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` There is a chapter in the NEMA book
` Q Well, I want to point your -- direct
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`your attention to six lines down. There is a
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` "Gas Vapor and Liquid Chemical
`sentence that says:
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`Sterilization."
` "Also, the sterilization treatment must not
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` Is that a chapter that you wrote,
`render the medical product, materials or functions
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`Mr. Agalloco?
`unacceptable." [As read.]
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` A Yes, I did.
` Do you see that?
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` A Yes, I do.
` Q All right, I'd like to turn to page --
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`that has .259 on the bottom.
` Q Is that something you agree with?
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` A I think it is one way of stating it.
` There is a section in the middle of
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`Yes, I do agree with it.
`that page that says:
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` "Gas, Vapor, and Liquid Sterilization
` Q What do you mean by "one way of stating
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`PLANET DEPOS
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`Novartis Exhibit 2339.004
`Regeneron v. Novartis, IPR2021-00816
`
`REDACTED VERSION
`
`

`

`Transcript of James Agalloco
`Conducted on May 4, 2022
`13
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`Fundamentals: Material Effects." Do you see
`that?
` A Yes.
` Q And the first sentence says:
` "Sterilization processes are designed to
`kill microorganisms and as such they utilize
`conditions that may be destructive of essential
`material properties." [As read.]
` Is that a sentence you agree with?
` A I wrote it, so yes, I agree with it.
` Q And the sterilization processes that
`are being referred to in that sentence, would that
`include the use of ethylene oxide and vaporized
`hydrogen peroxide?
` A Yes, it would.
` Q You agree, Mr. Agalloco, that a
`terminal sterilization process, in addition to
`achieving the appropriate level of sterilization,
`has to also avoid degradation of the drug product?
` A Yes, I do.
` Q Do you also agree that a sterilization
`process, in addition to achieving an appropriate
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`BY MS. HOLLAND:
` Q If the hydrogen peroxide or ethylene
`oxide is absorbed onto the rubber stopper, can it
`then leach into the drug product over time?
` MS. KENNEDY: Objection, form.
` THE WITNESS: Potentially. That's a
`possibility.
`BY MS. HOLLAND:
` Q Is it correct that if a sterilizing gas
`like hydrogen peroxide or ethylene oxide gets into
`a drug product, it can be impossible to remove it
`from the drug product?
` MS. KENNEDY: Objection, form.
` THE WITNESS: I'd say it would be
`extremely difficult to remove it. I can't say
`it's impossible. There may be methods.
`BY MS. HOLLAND:
` Q In your declaration, you talk about the
`claimed construction of terminal sterilization; do
`you recall that?
` A Yes, I do.
` Q Why don't we put that up on the screen?
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`level of sterilization, also has to avoid leaving
`traces of toxic substances that could make the
`drug product unsafe?
` MS. KENNEDY: Objection, form.
` THE WITNESS: Yes.
`BY MS. HOLLAND:
` Q Is it also true, Mr. Agalloco, that
`sterilizing gases can absorb onto syringe
`components during sterilization?
` A That's a possibility with some
`materials and some gases.
` Q Which gases?
` A There are many gases, and there are
`many materials. It is infinity combinations. I
`can't list them all.
` Q All right. Is it -- I appreciate that.
`Let me try again then.
` Is it correct that ethylene oxide and
`vaporized hydrogen peroxide can absorb onto a
`rubber stopper that's part of a prefilled syringe?
` MS. KENNEDY: Objection, form.
` THE WITNESS: It's possible, yes.
`
` It is exhibit 1100, at paragraph 20.
` (Whereupon, Exhibit 1100 was
`identified.)
`BY MS. HOLLAND:
` Q All right. At the bottom of page 8,
`it's in paragraph 20, you say:
` "I understand that, as used in the '631
`Patent, the parties have agreed that 'terminally
`sterilized' refers to a process whereby the
`outside of a prefilled syringe is sterilized,
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`the drug product within the syringe is minimized."
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`[As read.]
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` Do you see that?
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` A Yes, I do.
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` Q And is it correct that the reason for
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`minimizing the contact is to avoid chemical action
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`of the sterilizing agent on the contents of the
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`syringe, including the active ingredient?
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` MS. KENNEDY: Objection, form.
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` THE WITNESS: Yes, that would be the
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`PLANET DEPOS
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`Novartis Exhibit 2339.005
`Regeneron v. Novartis, IPR2021-00816
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`REDACTED VERSION
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`

`

`Transcript of James Agalloco
`Conducted on May 4, 2022
`17
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`5 (17 to 20)
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` (Whereupon, Exhibit 2330 was
`identified.)
` MS. KENNEDY: I'm going to object to
`the exhibit as outside the scope and to the extent
`that there is no authorization to file new
`exhibits in the surreply.
`BY MS. HOLLAND:
` Q All right. I'd like to go to page 74.
` It is not 74 of the exhibit, sorry. It
`is 74 of the transcript.
` Let's see if I can -- sorry, just one
`second. It's page 20. On the bottom it should
`have a 2330.0020.
` I want to look at page 74, and at line
`2, I asked you:
` "Question: So to figure out whether
`something is terminally sterilized, meaning had
`minimized contact, you would at least have to wait
`until stability is over because terminal
`sterilization could be a factor that affects
`degradation of the active." [As read.]
` I said, "Is that fair?"
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`BY MS. HOLLAND:
` Q Do you agree that in order to determine
`whether or not contact has been minimized, you
`would need to test the syringe, both
`post-sterility testing as well as post-stability
`testing?
` MS. KENNEDY: Objection, form.
` THE WITNESS: Can you repeat that for
`me, please?
`BY MS. HOLLAND:
` Q Yes, I can. You said in your last
`answer you agreed that minimizing contact is done
`so that you can avoid the chemical action of the
`sterilizing agent on the contents of the syringe,
`including the active.
` So now my question is: To determine
`whether or not that contact has actually been
`minimized, is it correct that you would need to
`test the active, both post-sterility testing, as
`well as after stability testing?
` MS. KENNEDY: Objection, form.
` THE WITNESS: If I understand your
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`question correctly, the answer would be yes, you
`would test immediately after sterilization, and
`test again at the end of the stability program.
`BY MS. HOLLAND:
` Q Okay, and you wouldn't know for sure
`whether or not you have successfully terminally
`sterilized until the end of stability testing; is
`that right?
` MS. KENNEDY: Objection, form.
`Objection, scope.
` THE WITNESS: That's actually not
`entirely true because you don't always have the
`full stability at the time of approval.
`BY MS. HOLLAND:
` Q All right. Are you -- let me ask this
`again. Let me do this differently. Sorry about
`that.
` I want to look at your deposition
`transcript from the ITC case. Let's see if we
`have that here.
` Can you put Exhibit 2330 on the screen,
`please.
`
` You answered:
` "Answer: You would make an immediate
`determination at the beginning, and you could only
`get definitive proof at the end of stability." [As
`read.]
` Do you still agree with that testimony?
` MS. KENNEDY: Objection, form,
`objection, scope.
` THE WITNESS: Yes, because exactly what
`I said just a few minutes ago when you asked a
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`Thank you. I want to go now to an exhibit that I
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` MS. KENNEDY: Objection to the exhibit,
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`BY MS. HOLLAND:
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`PLANET DEPOS
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`Novartis Exhibit 2339.006
`Regeneron v. Novartis, IPR2021-00816
`
`REDACTED VERSION
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`

`

`Transcript of James Agalloco
`Conducted on May 4, 2022
`21
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`6 (21 to 24)
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`processes and their subsequent validation?
` MS. KENNEDY: Objection, form,
`objection, scope.
` THE WITNESS: The thrust of this
`article is primarily to the treatment of isolators
`in which there is sterilization decontamination.
` It is somewhat different from the
`sterilization of objects in an autoclave, which is
`the subject of the '631 Patent.
`BY MS. HOLLAND:
` Q Let me try my question again.
` Do you agree with the sentence you
`wrote in September 2013, that persistent problems
`regarding the development of H²O² processes and
`their subsequent validation have been reported?
` MS. KENNEDY: Objection, form,
`objection, scope.
` THE WITNESS: I will repeat what I just
`said.
` This was directed at the treatment of
`isolators, in which you are dealing with an
`environment, a chamber, not the sterilization of
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` Q Mr. Agalloco, is this an article that
`you wrote?
` A Yes, I co-authored it with a good
`friend of mine, Dr. Aikers.
` Q And it was published in 2013; is that
`right?
` A I believe so.
` Q And in this article -- well, let me
`withdraw that.
` The article is called "Overcoming
`Limitations of Vaporized Hydrogen Peroxide"; is
`that right?
` A Yes.
` Q All right. I want to look at the
`fourth line, the last sentence.
` You say:
` "Some difficulties have been associated
`with the implementation of H²O² processes in the
`healthcare field." [As read.]
` Do you see that?
` A Not clearly. It is very small.
` Q Can we -- is there anyway to -- thank
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`objects like prefilled syringes in an autoclave.
`you.
` Quite a different process, quite a
` Can you see the sentence now?
` A Yes, I can.
`different level of sophistication in those. So,
`you are characterizing it too broadly.
` Q Is it correct that as of September 2013
`BY MS. HOLLAND:
`there were difficulties associated with the
` Q The article seems to apply broadly to
`implementation of vaporized hydrogen peroxide in
`vaporized hydrogen peroxide.
`the healthcare field?
` Is there something in the article that
` MS. KENNEDY: Objection, form,
`you say is limiting in some way?
`objection, scope.
` MS. KENNEDY: Objection, scope.
` THE WITNESS: Yes.
`0
` THE WITNESS: At the time the article
`BY MS. HOLLAND:
`11
`was published back in 2013, there was almost no
` Q And then if you go two lines down, it
`12
`discussion or even awareness of sterilization in
`says at the end of the line:
`13
`an autoclave using vapor-phased hydrogen peroxide.
` "Specifically, persistent problems
`14
` What was widely known was its use in
`regarding the development of H²O² processes and
`15
`environments, as I've outlined, and that's what
`their subsequent validation have been reported."
`16
`this article speaks towards.
`[As read.]
`17
`BY MS. HOLLAND:
` Do you see that?
`18
` A Yes.
` Q What do you mean when you say it was
`19
`almost unknown to use vaporized hydrogen peroxide
` Q Okay, so is it correct that as of
`20
`in autoclave?
`September 2013, there were reports of persistent
`21
` MS. KENNEDY: Objection, form,
`problems regarding the development of VHP
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`PLANET DEPOS
`888.433.3767 | WWW.PLANETDEPOS.COM
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`Novartis Exhibit 2339.007
`Regeneron v. Novartis, IPR2021-00816
`
`REDACTED VERSION
`
`

`

`Transcript of James Agalloco
`Conducted on May 4, 2022
`25
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`7 (25 to 28)
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`directed towards.
`BY MS. HOLLAND:
` Q All right. Which the article was
`directed towards, but doesn't actually say.
` MS. KENNEDY: Objection, form,
`objection, scope.
` THE WITNESS: It mentions isolators in
`several locations, and again I will tell you the
`use of it in an autoclave type setting was not
`widely known in 2013.
`BY MS. HOLLAND:
` Q What do you mean by "was not widely
`known"?
` MS. KENNEDY: Objection, form,
`objection, scope.
` THE WITNESS: I work in sterilization
`all the time. I can tell you in 2013 there was
`almost no knowledge of the deep vacuum hydrogen
`peroxide process.
`BY MS. HOLLAND:
` Q Did you say "deep vacuum"?
` A Yes.
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`objection, scope.
` THE WITNESS: That's a sterilization
`process that's under the subject of the '631
`Patent and these Sigg and Lam references.
` That's a process in which you have a
`chamber, and you put objects in to sterilize;
`that's the only purpose of that chamber.
` This article was addressed towards
`environments, rooms, enclosures, if you would, in
`which a process occurs. Lots of different types
`of equipment and quite a different situation from
`that use for single, very common, uniform types of
`devices as in the '631 Patent.
`BY MS. HOLLAND:
` Q All right. I'm asking you a different
`question though.
` I asked you whether there's something
`in this article that says that.
` MS. KENNEDY: Objection, form,
`objection, scope.
` THE WITNESS: At that time, it does
`not. I have since written other articles which
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`make that distinction.
`BY MS. HOLLAND:
` Q Can we go to page .006 of the article,
`which is in Exhibit 2328. I want to look at that
`paragraph that says, "Biological Indicator
`Issues." Thank you.
` The first sentence says:
` "Difficulties encountered in the
`destruction of biological indicators have been
`commonly reported and are so well-known that there
`are some who doubt the efficacy of H²O² as a
`sterilant." [As read.]
` Do you see that?
` MS. KENNEDY: Objection, scope.
` THE WITNESS: Yes, I do.
`BY MS. HOLLAND:
` Q Was that sentence correct as of 2013?
` A As it related to --
` MS. KENNEDY: Objection, scope.
` THE WITNESS: As it related to the
`types of systems and as -- again, I repeat --
`isolators, primarily, which the article was
`
` MS. KENNEDY: Objection, form.
`BY MS. HOLLAND:
` Q I just want to explore what you said
`about deep vacuum and make sure I understand it.
` Is vaporized hydrogen peroxide, as in
`the Sigg reference, for example, is that performed
`under vacuum?
` MS. KENNEDY: Objection, form,
`objection, scope.
` THE WITNESS: If you can open the
`0
`portion of it, let's take a look at that. Let's
`11
`open the Sigg reference and see what they say
`12
`about it, please.
`13
`BY MS. HOLLAND:
`14
` Q I'm going do that in a second, but let
`15
`me ask it more broadly first: Is it correct that
`16
`in general as of 2012, that vaporized hydrogen
`17
`peroxide was performed under vacuum?
`18
` MS. KENNEDY: Objection, form.
`19
` THE WITNESS: It is performed in a
`20
`variety of ways, some with vacuum and some
`21
`without.
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`PLANET DEPOS
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`Novartis Exhibit 2339.008
`Regeneron v. Novartis, IPR2021-00816
`
`REDACTED VERSION
`
`

`

`Transcript of James Agalloco
`Conducted on May 4, 2022
`29
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`8 (29 to 32)
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`objection, scope.
` THE WITNESS: Repeat that again,
`please.
`BY MS. HOLLAND:
` Q Let me take you back to 2012, okay.
` Would a person of skill in the art in
`2012 have known about performing VHP sterilization
`in an autoclave?
` MS. KENNEDY: Objection, form,
`objection, scope.
` THE WITNESS: They would have known
`about the ASP with Johnson & Johnson, ASP product.
` They may have been aware of any deep
`vacuum type process that, you know, is really
`central to the '631 Patent.
`BY MS. HOLLAND:
` Q Do you know whether ASP used a vacuum
`or not?
` MS. KENNEDY: Objection, form,
`objection, scope.
` THE WITNESS: My understanding is that
`they do use a vacuum.
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`BY MS. HOLLAND:
` Q Was that true as of 2012?
` MS. KENNEDY: Objection, form.
` THE WITNESS: As I'm now aware of, yes,
`it was true in 2012.
` Q What do you mean, as you are now aware
`of?
` MS. KENNEDY: Objection, form.
` THE WITNESS: When you look into the
`depths of the '631 Patent and the processes
`involved, it is clear there is a deep vacuum
`technology. That was not widely disclosed and,
`you know, when this article was written, it was
`not considered.
`BY MS. HOLLAND:
` Q Let me ask my question the little
`differently. I'm sorry, Mr. Agalloco. I think
`maybe I didn't phrase it properly.
` If you were going to use that autoclave
`method of VHP sterilization as of 2012, would you
`have done it under vacuum?
` MS. KENNEDY: Objection, form.
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` THE WITNESS: In 2012, as I mentioned
`previously, I was unaware of the deep vacuum
`system. It was not widely discussed, so I would
`not have.
`BY MS. HOLLAND:
` Q Were you -- as of 2012, is it correct
`that you would apply a post-treatment vacuum
`procedure after a treatment with sterilizing
`gases?
` MS. KENNEDY: Objection, form,
`objection, scope.
` THE WITNESS: One would have to do that
`carefully. It was done with ethylene oxide.
` In my experience with the ambient
`pressure hydrogen peroxide, that would not have
`been necessary and would not have been used.
`BY MS. HOLLAND:
` Q I want to make sure I understand your
`testimony. Are you saying that you were aware of
`ambient pressure hydrogen peroxide sterilization
`in an autoclave as of 2012?
` MS. KENNEDY: Objection, form,
`
`BY MS. HOLLAND:
` Q Okay, so I'm going to ask the question
`again: As of 2012, would a person of ordinary
`skill in the art have understood that with a
`vaporized hydrogen peroxide process in an
`autoclave, you would perform it under vacuum?
` MS. KENNEDY: Objection, form,
`objection, scope.
` THE WITNESS: Within the ASP, yes, they
`would not know of any other types of processes or
`0
`may not know of them.
`11
`BY MS. HOLLAND:
`12
` Q Okay, so is it your testimony that the
`13
`only process that they would have known about --
`14
`well, let me withdraw that.
`15
` Is it your testimony that as of 2012,
`16
`the only vaporized hydrogen peroxide process that
`17
`a person of ordinary skill in the art would have
`18
`known about would have been the ASP process?
`19
` MS. KENNEDY: Objection, form,
`20
`objection, scope.
`21
` THE WITNESS: That's -- I have come to
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`PLANET DEPOS
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`Novartis Exhibit 2339.009
`Regeneron v. Novartis, IPR2021-00816
`
`REDACTED VERSION
`
`

`

`Transcript of James Agalloco
`Conducted on May 4, 2022
`33
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`9 (33 to 36)
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` MS. KENNEDY: Objection, form,
`objection, scope.
` THE WITNESS: One of the common
`representations of isolators is that they are very
`small rooms.
`BY MS. HOLLAND:
` Q So the sterilization is done not in an
`autoclave but in a small room; is that what you're
`saying?
` MS. KENNEDY: Objection, form,
`objection, scope.
` THE WITNESS: Yes, that's what I'm
`saying.
`BY MS. HOLLAND:
` Q And that's different than what ASP was
`doing?
` MS. KENNEDY: Objection, form,
`objection, scope.
` THE WITNESS: Yes, that is different.
`BY MS. HOLLAND:
` Q Let's now go to the Sigg publication.
`It's Exhibit 1007.
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`learn that that's not the case, but my own
`personal knowledge at that time, I was unaware of
`it.
`BY MS. HOLLAND:
` Q Were you aware of ASP or unaware of it
`in 2012?
` MS. KENNEDY: Objection, form,
`objection, scope.
` THE WITNESS: I am aware of ASP, yes,
`then and at that time as well.
`BY MS. HOLLAND:
` Q And were you aware at that time that
`ASP process was done under vacuum?
` MS. KENNEDY: Objection, scope.
` THE WITNESS: Yes.
`BY MS. HOLLAND:
` Q Were you aware of any processes that
`were not -- withdraw.
` Were you aware of any VHP processes
`that were not performed under vacuum?
` MS. KENNEDY: Objection, scope.
` THE WITNESS: Yes, that's the subject
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`of this article.
`BY MS. HOLLAND:
` Q And that would be a -- well, let me
`withdraw that.
` What did you say that the subject of
`the article was?
` MS. KENNEDY: Objection, form,
`objection, scope.
` THE WITNESS: This is basically
`discussing ambient pressure, so just applied some
`pressure in a room.
`BY MS. HOLLAND:
` Q Just so everyone is clear, what you are
`saying is that this is an article about doing the
`whole process under vaporized hydrogen peroxide,
`right?
` MS. KENNEDY: Objection, form,
`objection, scope.
`BY MS. HOLLAND:
` Q Let me withdraw that.
` What did you mean by doing it in a
`room?
`
` (Whereupon, Exhibit 1007 was
`identified.)
`BY MS. HOLLAND:
` Q Let's look at example 1, which is on
`page .021. Okay, and you see in the first
`sentence it says:
` "In the following experiment, prefilled
`syringes were treated with a vaporized hydrogen
`peroxide sterilization treatment in a chamber."
`[As read.]
`0
` Do you see that?
`11
` A Yes, I do.
`12
` Q Okay, but can you tell from that
`13
`sentence what type of VHP use this is?
`14
` A No.
`15
` Q Let me ask you this: You don't recall
`16
`from your review of the Sigg article -- I'm sorry,
`17
`the Sigg application -- whether this was a
`18
`treatment that was performed under vacuum or not?
`19
` MS. KENNEDY: Objection, form.
`20
` THE WITNESS: What you see here in this
`21
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`PLANET DEPOS
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`Novartis Exhibit 2339.010
`Regeneron v. Novartis, IPR2021-00816
`
`REDACTED VERSION
`
`

`

`Tran