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`UNITED STATES PATENT AND TRADEMARK OFFICE
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`--------------------------------------
`LUPIN LTD and LUPIN
`PHARMACEUTICALS INC.,
`
`Petitioners,
`
`v.
`
`HORIZON THERAPEUTICS, INC.,
`
`Patent Owner.
`
`--------------------------------------
`IPR2016-00829
`
`DEPOSITION OF KEITH K. VAUX,
`M.D., a Witness herein, taken by
`Petitioners at the offices of Goodwin
`Procter LLP, 620 Eighth Avenue, New York,
`New York, on Tuesday, January 31, 2017, at
`9:01 a.m., before Debra Stevens, a
`Certified Realtime and Registered
`Professional Reporter and Notary Public
`within and for the State of New York.
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`Horizon Exhibit 2034
`Lupin v. Horizon
`IPR2017-01159
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`--------------------------------------
`LUPIN LTD and LUPIN
`PHARMACEUTICALS INC.,
`
`Petitioners,
`
`v.
`
`HORIZON THERAPEUTICS, INC.,
`
`Patent Owner.
`
`--------------------------------------
`IPR2016-00829
`
`DEPOSITION OF KEITH K. VAUX,
`M.D., a Witness herein, taken by
`Petitioners at the offices of Goodwin
`Procter LLP, 620 Eighth Avenue, New York,
`New York, on Tuesday, January 31, 2017, at
`9:01 a.m., before Debra Stevens, a
`Certified Realtime and Registered
`Professional Reporter and Notary Public
`within and for the State of New York.
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`Horizon Exhibit 2034
`Lupin v. Horizon
`IPR2017-01159
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`
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`Page 2
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`A P P E A R A N C E S :
`GREEN, GRIFFITH & BORG-BREEN LLP
` Attorneys for Petitioner
`NBC Tower
`455 N. Cityfront Plaza Dr., Suite 3100
`Chicago, Illinois 60611
` BY: ROBERT F. GREEN, ESQ.
` rgreen@greengriffith.com
` EMER SIMIC, ESQ.
` esimic@greengriffith.com
`FINNEGAN, HENDERSON, FARABOW, GARRETT &
`DUNNER, LLP
` Attorneys for Petitioner
`201 New York Avenue, NW
`Washington, DC 20001-4413
` BY: MAUREEN D. QUELER, ESQ.
` maureen.queler@finnegan.com
`
`GOODWIN PROCTER LLP
` Attorneys for Patent Owner
`The New York Times Building
`620 Eighth Avenue
`New York, New York 10018
` BY: ROBERT V. CERWINSKI, ESQ.
` rcerwinski@goodwinlaw.com
`
` * * *
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`Page 3
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` E X A M I N A T I O N S
` Witness Page
` K. Vaux
` By Mr. Green 4
` By Mr. Cerwinski 107
`
` E X H I B I T S
`
` Horizon
` Exhibit Description Page
` Exh 2035 Dr. Vaux's bio web page 5
` from UC San Diego
`
` Exh 2036 "Novel Human 8
` Pathological Mutations"
` Exh 2037 Book review of "A 13
` Clinical Guide to
` Inherited Metabolic
` Deseases, 2nd ed."
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`Whereupon,
` K E I T H K. V A U X,
`having been first duly sworn/affirmed,
`was examined and testified as follows:
`EXAMINATION BY
`MR. GREEN:
` Q. Morning, Dr. Vaux.
` A. Good morning.
` Q. Would you state your full name
`for the record?
` A. Sure. Keith Kenneth Vaux.
` Q. I am going to start by handing
`you what has been previously marked as
`Lupin Exhibit 1003.
` A. Okay.
` Q. Is that your curriculum vitae?
` A. Yes, it is.
` Q. Do you see up near the top,
`under "business address" there is an entry
`for Point Loma Pediatrics?
` A. Right.
` Q. What is Point Loma Pediatrics?
` A. It is a pediatric clinic, a
`private pediatric clinic in Point Loma.
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` K. VAUX
` Q. Are you one of the owners of
`Point Loma Pediatrics?
` A. No. My wife owns it.
` Q. Do you work for Point Loma
`Pediatrics?
` A. Yes.
` Q. Is it fair to characterize Point
`Loma Pediatrics as a general pediatric
`practice?
` A. Yes.
` Q. Looking down the first page of
`Lupin Exhibit 1003, under "Employment" I
`see you have an entry for July 7, 2014, to
`present. It has "Director and Clinical
`Chief, Division of Medical Genetics at
`University of California, San Diego."
`Correct?
` A. That is correct.
` Q. I am going to hand you a
`document we are marking Horizon
`Exhibit 2035.
` (So marked for identification as
` Horizon Exhibit 2035.)
` Q. This was a page retrieved from
`
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` K. VAUX
`the online website for the University of
`California San Diego. Do you recognize
`this page?
` A. I recognize all the elements in
`it. I am not sure I have seen the
`specific page.
` MR. CERWINSKI: Objection.
` Authenticity.
` Q. If you can take a look at the
`description under "Bio" I would like you
`to read through it since you don't
`recognize the page. If you can let me
`know, after you do that, if this is a
`correct statement of your background.
` (Pause)
` A. That is correct. The Jacobs
`Medical Center address at the top is
`probably not -- I am not technically
`located there nor do I have an office in
`Hillcrest, the second. Those are just
`general addresses. That would be the only
`thing I would correct on that.
` Q. With respect to the discussion
`of your bio on this page, is that correct?
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` K. VAUX
` A. Yes, that is correct.
` Q. I note at the top portion of the
`bio, in the first paragraph -- I will read
`this into the record -- it says, "He has
`special interest in neurologic genetic
`diseases and conditions that are difficult
`to diagnose, as well as using next
`generation sequencing tools to diagnose
`rare conditions and understand the
`genetics of chronic common conditions."
` Did I read that correctly?
` A. You did. I think that at the
`beginning of the piece I also taught that
`I work on the diagnosis, evaluation and
`long-term care of patients with complex
`genetic disorder.
` Q. With respect to your interest in
`the identification of neurologic genetic
`diseases and conditions, are you involved
`in identifying the underlying genetic
`cause for conditions such as those?
` MR. CERWINSKI: Object to the
` form.
` A. Could you say it again, sir?
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` K. VAUX
` Q. Sure. Is your emphasis, at
`least in part, looking for the underlying
`genetic mutation that causes diseases that
`fall in this category of neurologic
`genetic diseases?
` A. That is one subset of what I am
`interested in; yes.
` Q. Looking at your CV, on labeled
`page 7 of 9?
` A. Okay.
` Q. There is an entry number 16 that
`refers to a document that is titled "Novel
`Human Pathological Mutations."
` Do you see that?
` A. Yes, I do.
` Q. I am going to hand you Horizon
`Exhibit 2036.
` (So marked for identification as
` Horizon Exhibit 2036.)
` Q. Is Horizon Exhibit 2036 the
`document to which you refer in your CV
`under number entry 16?
` A. To which part in particular?
`This is a list of other mutations.
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` K. VAUX
` Q. Correct. So, if I can point you
`to the bottom of page 341?
` A. 341.
` MR. CERWINSKI: I will lodge an
` objection to authenticity.
` A. So, what you have provided me
`with here is a list of the mutations that
`were published in Human Genetics. And I
`was a participant in the identification of
`this particular gene.
` Q. You are referring to the entry
`at the bottom of numbered page 341 of
`Horizon Exhibit 3036?
` A. Correct.
` Q. And the gene mutation in this
`related to the disease condition known as
`Citrullinaemia?
` A. That is correct.
` Q. How do you pronounce that,
`Doctor?
` A. "Sit-rullin-emia."
` Q. Okay. Another reason why I
`decided not to go into biological
`sciences.
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` K. VAUX
` Just for the record, what is
`Citrullinaemia?
` A. It is an inborn error of
`metabolism.
` Q. With respect to the reference to
`individuals on this page, you are one of
`many. Is it fair to state that your
`interest and involvement with respect to
`the location and identification of the
`mutation, that was the reason why you
`participated in this study?
` MR. CERWINSKI: Objection to the
` form.
` A. What I am hearing you say is
`that the goal of this paper, from my
`participation, was to diagnose this
`condition. Is that what you are asking
`me?
` Q. To diagnose a potential cause
`for the condition?
` A. One of the reasons that I
`participated in this paper was because I
`diagnosed this condition in a patient and
`then identified what was responsible for
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` K. VAUX
`that condition. So, we were able to
`identify a new gene.
` Q. So your participation in this
`study, then, resulted in the
`identification of the gene which is
`identified at the bottom of page 341 of
`this Exhibit 2036. Is that correct?
` MR. CERWINSKI: Objection to the
` form.
` A. I contributed, actually, several
`patients to the series that allowed the
`identification of the gene involved in
`this condition.
` Q. So your principal role in the
`identification of this gene was providing
`the patient information to assist in that?
` A. And identifying the diagnosis
`itself.
` Q. Turn back to your CV.
` A. Okay.
` Q. Under numbered publication 19 --
` A. Okay.
` Q. There is a reference to a
`document entitled "The Role of Molecular
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` K. VAUX
`Testing and Enzyme Analysis in the
`Management of Hypomorphic
`Citrullinaemia--" or something close to
`that. Is that correct?
` A. That is correct.
` Q. Is the article that you have set
`forth under publication 19, then, the
`underlying study discussion that relates
`to the Exhibit 16 document that identifies
`the particular mutation?
` A. This was the initial paper that
`was published that set forth a variety of
`new genes involved in the Citrullinaemia.
` Q. And the study that is reflected
`in this document identified by publication
`19, was that the study from which the gene
`identification that is set forth in
`publication 16 resulted?
` A. Yes, I believe so. Yes.
` Q. Also on your CV, if you can turn
`to the page that is numbered 8 of 9 in the
`bottom right corner?
` A. 8 of 9.
` Q. The first publication that is
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` K. VAUX
`listed as number 1, "A clinical guide to
`inherited metabolic diseases, 2nd
`edition," do you see that?
` A. I do.
` Q. I am going to hand you Horizon
`Exhibit 2037.
` (So marked for identification as
` Horizon Exhibit 2037).
` Q. Is the book review that is
`reflected in Horizon Exhibit 2037 the
`article that you have set forth here under
`"Other Publications" at number 1?
` A. I haven't seen it in this form,
`but it certainly looks like the one that I
`wrote.
` MR. CERWINSKI: Objection.
` Authenticity.
` Q. Was the review that you wrote
`published in the Journal of Heredity 2003?
` A. Yes, it was.
` Q. Was that article published in
`2003?
` A. Yes.
` Q. Do you have any reason to
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` K. VAUX
`believe that this is not the review that
`is referenced at publication number 1
`under "Other Publications"?
` A. I have no reason to believe it's
`not.
` Q. If you just take a moment to
`look at the contents to again make sure
`that you have no issue with respect to
`this being the actual review that is
`referenced at publication number 1 under
`"Other Publications"?
` MR. CERWINSKI: Objection to the
` form.
` A. To the best of my recollection,
`this does look like the one that I wrote.
` Q. With respect to the underlying
`publication that you are reviewing that is
`the publication titled "A Clinical Guide
`to Inherited Metabolic Diseases 2nd
`Edition," you did not write that
`publication itself, right, the one --
` A. That is correct. This is a
`review.
` Q. Did you play any role in editing
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` K. VAUX
`the publication "A Clinical Guide to
`Inherited Metabolic Diseases"?
` A. I did not.
` Q. And that publication, that
`Clinical Guide to Inherited Metabolic
`Diseases is a clinical guide. Is that
`correct?
` A. That is correct.
` Q. If you could for a moment,
`please, take a look at the entries under
`"Publications" and "Other Publications" on
`your CV, Lupin Exhibit 1003? Setting
`aside the publications 16 and 19 under the
`heading "Publications" and under "Other
`Publications," the one we discussed that
`is numbered 1, do any of the other
`publications that you set forth under
`those headings "Publications" and "Other
`Publications" relate to the treatment of
`urinary -- sorry -- urea cycle disorder?
` MR. CERWINSKI: Objection to the
` form.
` A. You are asking specifically
`about urea cycle defects?
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` K. VAUX
` Q. Yes.
` A. There are not other specific
`publications related to that topic.
` Q. Are you a member of the Urea
`Cycle Disorders Consortium?
` A. What do you mean exactly by
`that, am I a member?
` Q. So, are you familiar with the
`consortium?
` A. I am.
` Q. And does it have a membership?
` A. I am not aware of the presence
`or absence of that.
` Q. So, you --
` A. Is it an interest group, or is
`it -- well, let it be.
` Q. Is anyone in the group at which
`you practice at University of California
`San Diego a member of the consortium?
` MR. CERWINSKI: Objection to the
` form. Objection; foundation.
` A. I am not aware of the presence
`or absence of any of my colleagues on such
`forum.
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` K. VAUX
` Q. Are you a member of the Society
`of Inherited Metabolic Disorders?
` A. I am not.
` Q. And are you a member of the
`Society For the Study of Inborn Errors of
`Metabolism?
` A. I am not.
` Q. Have you attended conferences
`held by the Society For Inherited
`Metabolic Disorders?
` A. Not that I am aware of.
` Q. Have you had any publications in
`The Journal For Inherited Metabolic
`Diseases?
` A. I have not.
` Q. Have you had any articles
`published in The Journal for Molecular
`Genetics and Metabolism?
` A. I have not.
` Q. Have you been a lead
`investigator for any clinical trial that
`involved the treatment of UCD patients?
` MR. CERWINSKI: Objection to the
` form.
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` K. VAUX
` A. I have been involved in other
`studies of inborn errors of metabolism,
`not specifically urea cycle defects.
` Q. And in my question I referred to
`UCD. You understood that to refer to urea
`cycle defects?
` A. I did.
` Q. Is it all right with you if I
`abbreviate "urea cycle defects" to "UCD"?
` A. No, I would ask -- yes. It's
`okay with me.
` Q. Thank you.
` A. You're welcome.
` Q. You are board certified in the
`field of pediatrics?
` A. That is correct.
` Q. Are you board certified in any
`other areas?
` A. No, just pediatrics.
` Q. You are not certified in the
`fields of clinical genetic or biochemical
`genetics?
` A. That is correct.
` Q. Have you received any grants
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` K. VAUX
`that related to studies concerning the
`treatment of UCD?
` MR. CERWINSKI: Objection to the
` form.
` A. Specifically what kind of grants
`are you referring to?
` Q. Monetary grants such as those
`given by NIH or other institutions.
` A. Specifically related to UCD?
` Q. Yes.
` A. No.
` Q. I am going to hand you a
`document previously marked as Lupin
`Exhibit 1002. It's captioned "Declaration
`of Kenneth Vaux."
` A. "Vox"; excellent. I only use
`"Keith" in this.
` Q. Thank you for the correction.
` A. You are welcome.
` Q. Is this a declaration which you
`prepared?
` A. Yes. Actually, I believe this
`is the same one as the one I prepared.
` Q. If you could turn to paragraph
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`19, which is on the bottom of the page
`numbered 11 of 57?
` A. Yes. I have it.
` Q. In paragraph 19 this is your
`expression of your opinion as to how a
`person of ordinary skill should be defined
`when taking into account the claims that
`are set forth in the patent that's
`involved in the IPR for which you are
`testifying today. Is that correct?
` MR. CERWINSKI: Objection to the
` form.
` A. Yes. This was my opinion.
` Q. If we could, perhaps, take a
`closer look at what you set forth as your
`definition of a person of ordinary skill
`in the art?
` A. Of course.
` Q. You state, for example, that it
`would be a physician with an MD degree
`with a residency in pediatrics or internal
`medicine and would have had specialized
`training in the diagnosis or treatment of
`inherited metabolic disorders such as UCDs
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`and other nitrogen retention disorders.
`Correct?
` A. That is correct.
` Q. So, first, what do you mean by
`"specialized," when you refer to the type
`of training that a POSA should have had?
` A. This is direct experience or
`formal training, either one.
` Q. When you say direct experience
`or formal training, in what respect?
` A. During residency, exposure to
`inherited metabolic diseases. In absence
`of that, it would be additional classes,
`additional clinical experiences or other
`training.
` Q. So with respect to the term
`"inherited metabolic disorders" as you use
`it in paragraph 19, how many such
`disorders exist?
` MR. CERWINSKI: Objection to the
` form.
` A. There are extensive numbers. I
`don't believe I could give you an absolute
`number because with the onset of genetic
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`testing there has been more that have been
`identified.
` Q. Is it fair to say it is in the
`hundreds?
` MR. CERWINSKI: Objection to the
` form.
` A. I wouldn't be able to even give
`a general estimate.
` Q. And UCD is just one of those
`many inherited metabolic disorders?
` A. That is correct.
` Q. So, is my understanding correct
`that using your definition of a person of
`ordinary skill in the art, a physician
`that meets the other criteria, who then
`obtained specialized training in the
`diagnosis or treatment concerning an
`inherited metabolic disorder other than
`UCD would qualify as a person of ordinary
`skill in the art. Correct?
` MR. CERWINSKI: Objection to the
` form.
` A. There are too many turns in
`that. Would you say it again, please?
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` Q. Let me see if I can shorten it
`up.
` A. Thank you.
` Q. Your POSA could be an individual
`who has specialized training in diagnosis
`or treatment of inherited metabolic
`disorders other than UCD. Is that
`correct?
` A. That is correct.
` Q. And in your definition, is it
`also correct that a POSA could have
`specialized training with respect to the
`diagnosis of UCD but not with respect to
`the treatment of UCD?
` MR. CERWINSKI: Objection to the
` form.
` A. I would have difficulty
`generalizing that.
` Q. What I am trying to do is
`understand the specialized training in the
`diagnosis or treatment. Again, if an
`individual had the training in how to
`diagnose, for example, UCD but no training
`in the treatment, that person would also
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`qualify as a POSA in your definition. Is
`that correct?
` A. It would be, again, very hard
`for me to imagine that that would occur.
` Q. Hypothetically speaking, if such
`a POSA existed and had such training only
`with respect to diagnosis and not with
`respect to treatment, that person would
`fall within your definition of a POSA?
` A. That is correct, as a very
`hypothetical. But the specialized
`training is involved in identifying,
`diagnosing and treating patients.
` MR. CERWINSKI: I will object as
` an incomplete hypothetical.
` Q. So, again turning back to
`paragraph 19, if we have an individual who
`is a physician with an MD degree and a
`residency in pediatrics or internal
`medicine, how much specialized training
`would that individual need to qualify as a
`POSA under your definition?
` A. There would not be any limit or
`any -- most of the pediatric and internal
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`medicine residencies would cover the vast
`majority of the basic knowledge. There is
`also quite a bit that's obtained in the MD
`degree.
` So, I don't think that there
`would be an absolute minimum amount or an
`absolute maximum amount.
` Q. In order to qualify under that
`definition, in what subject area would the
`residency have been required?
` MR. CERWINSKI: Object to the
` form.
` A. Can you say it again?
` Q. So if the individual we are
`talking about went through a residency, is
`there a particular protocol that that
`resident would have had to have undergone
`to receive that training?
` MR. CERWINSKI: Objection to the
` form.
` A. There are standards for
`education both as an MD and as a resident.
`They have standards of exposure and
`knowledge that are frequently tested and
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`outlined in multiple journals -- multiple
`documents, that require a person with an
`MD to have had exposure to what I
`mentioned, as well as a residency in
`pediatrics to have exposure to inherited
`metabolic disorders.
` Q. So the residency would have been
`required to have been in the field of
`pediatrics to satisfy your definition of
`POSA?
` A. Or internal medicine.
` MR. CERWINSKI: You should pause
` before giving your answer so I have
` time to lodge an objection.
` THE WITNESS: Got it.
` MR. CERWINSKI: Thanks.
` Q. I am going to hand you
`previously marked Lupin Exhibit 1001.
`It's United States Patent 9,095,559.
` Dr. Vaux, you have reviewed this
`patent?
` A. I have.
` Q. I would like for you to turn to
`the claims, which start at page numbered
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`21 of 22 in Lupin Exhibit 1001.
` If you will also look at the
`same time to your declaration at pages 52
`and 54 -- sorry. Paragraphs 52 and 54.
`My questions will be directed toward the
`interpretation of claims 1 and 2 to start
`with. It might be useful for you,
`Dr. Vaux, if you looked at those two
`paragraphs to refresh your recollection.
` A. I am sorry. Could you say again
`which ones?
` Q. 52 and 54.
` Before I ask the question, I'd
`like to see if we can agree on another
`shortened term. If you look at, for
`example, claim 1, you see the chemical
`identified as glyceryl Tri-[4-
`phenylbutyrate]?
` Do you see that?
` A. I do.
` Q. Is it satisfactory with you if I
`refer to that simply as glyceryl
`phenylbutyrate?
` A. That is okay with me.
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` Q. With that understanding, do you
`agree that claims 1 and 2 relate to
`adjusting the dose of glyceryl
`phenylbutyrate to be administered to a
`patient who is being treated for UCD, has
`received a previous dose of glyceryl
`phenylbutyrate, has been determined to
`have a fasting plasma ammonia level less
`than the upper limit of normal and has a
`fasting plasma ammonia level that is
`greater than half the upper limit of
`normal?
` MR. CERWINSKI: Objection to the
` form.
` A. You are asking me specifically
`if, in my statement, or in your statement,
`the question is -- I am a little confused
`as to which one you want me to say.
` So, in my statement 52, the 1
`and 2 are directed at adjusting a dosage
`of glyceryl phenylbutyrate which has been
`previously administered to a subject. I
`agree with that; yes.
` And 54, I refer specifically to
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`your patent application, 1001 and put in
`quotation "who has a fasting plasma
`ammonia level less than the upper limit of
`normal."
` At no time did I say in there
`about half. So, I would agree with
`everything except the statement about
`half.
` Q. I wanted to refresh your
`recollection as to what you had in your
`declaration. But what I would like to
`know now, after you have had the
`opportunity to read through those
`paragraphs as well as claims 1 and 2, if
`you agree that what both claim 1 and claim
`2 require is really all of those
`attributes with respect to the patient:
`that the patient is being treated for UCD,
`that the patient has been given a previous
`dose of glyceryl phenylbutyrate, that the
`patient has been determined to have a
`fasting plasma ammonia level that is less
`than the upper limit of normal and that
`the fasting plasma ammonia level for that
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`patient is greater than half the upper
`limit of normal.
` MR. CERWINSKI: Objection to the
` form. Calls for a legal conclusion.
` Objection to form; and objection it
` calls for a legal conclusion.
` A. I am still not sure exactly what
`you are asking me here. Do you want me to
`comment on claim 1 and 2, that they have
`those components that are considered
`together? Or -- I am not clear on what
`exactly you want me to respond to.
` Q. Sure. Have you been involved
`with any patent prosecution for patents of
`your own?
` A. Of my own patents, I have not.
` Q. And have you reviewed patents
`prior to your becoming involved in the
`present IPR that brings us here today?
` A. I have.
` Q. And have you, prior to being
`involved in this present IPR, looked at
`the claims in patents?
` A. I have.
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` Q. And have you looked at the
`claims to determine what subject matter is
`covered by such claims?
` MR. CERWINSKI: Objection to the
` form.
` A. Say that last one again?
` Q. Sure. And have you looked at
`patent claims, prior to your involvement
`in the present IPR, to determine what the
`subject matter is that is covered by those
`claims?
` MR. CERWINSKI: Objection to the
` form.
` A. That last part I am not sure I
`can answer.
` Q. In your declaration you have
`provided some opinions that apply prior
`art to the claims of this patent.
`Correct?
` A. That is correct.
` Q. What I am trying to determine is
`whether you have the same understanding as
`I expressed for what the claim requires in
`order to define the invention that falls
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`within claim 1 and claim 2.
` MR. CERWINSKI: Objection to the
` form.
` A. Right. And I stated this in 52
`and in 54, of what I understand to be
`claimed in 1 and 2. I don't think there
`is any variation off of that.
` Q. I think you perhaps identified
`the only element, though, that was not in
`those two paragraphs, and that is the
`requirement that the patient being treated
`has a fasting blood ammonia level that's
`greater than half the upper limit of
`normal.
` MR. CERWINSKI: Objection to the
` form.
` A. If I am hearing you correct, the
`question that you are asking me is do I
`see on Exhibit 1001 that adjusting
`includes a fasting plasma ammonia level
`greater than half the upper limit of
`normal for the plasma ammonia level. Is
`that what you are asking me? Do I see
`that on the claim?
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` Q. Let's start with that.
` A. Okay. Yes, I see that on the
`claim.
` Q. And do you understand, then,
`that this claim requires that the patient
`be in such a state that the measured
`fasting blood ammonia level is not only
`below the upper limit of normal but is
`also greater than half the upper limit of
`normal?
` A. Yes, I do see that in item 1(c).
` Q. And when you were evaluating the
`prior art for purposes of your
`declaration, did you take into account the
`four factors, as I expressed, that is
`required for the patient being treated;
`that is, that the patient is being treated
`for UCD, that the patient has had a
`previous dose of glyceryl phenylbutyrate,
`that the patient's fasting plaza ammonia
`level is less than the upper limit of
`normal, and that the fasting plasma
`ammonia level for that patient is greater
`than half the upper limit of normal?
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` A. Yes; that would be what I did
`consider.
` Q. If you could look at claim 3?
` A. Okay.
` Q. In claim 3, if you compare claim
`3 to claims 1 and 2, there is no
`requirement in claim 3 for the pati
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