UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________
`
`LIQUIDIA TECHNOLOGIES, INC.,
`Petitioner
`
`v.
`
`UNITED THERAPEUTICS CORPORATION.
`Patent Owner
`
`_______________
`
`Trial No. IPR2021-00406
`Patent No. 10,716,793 B2
`_______________
`
`DECLARATION OF Ms. PILAR WYMAN
`
`IPR2021-00406
`United Therapeutics EX2041
`
`
`_______________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________
`
`LIQUIDIA TECHNOLOGIES, INC.,
`Petitioner
`
`v.
`
`UNITED THERAPEUTICS CORPORATION.
`Patent Owner
`
`_______________
`
`Trial No. IPR2021-00406
`Patent No. 10,716,793 B2
`_______________
`
`DECLARATION OF Ms. PILAR WYMAN
`
`IPR2021-00406
`United Therapeutics EX2041
`
`
`
`IPR2021-00406
`
`I, Pilar Wyman, hereby declare:
`
`INTRODUCTION
`
`1.
`
`I am a paid consultant for United Therapeutics Corporation in
`
`connection with this proceeding, IPR2021-00406. My compensation does not
`
`depend on the content of this declaration, the substance of any other testimony that
`
`I may offer in connection with this proceeding, or the disposition of this
`
`proceeding.
`
`2.
`
`I am a professional freelance medical indexer and indexing consultant.
`
`My Curriculum Vitae describing my background and experience is provided as
`
`Exhibit 2042. I have personal knowledge of the facts and opinions set forth in this
`
`declaration, which I believe to be true, and if called upon to do so, I would testify
`
`competently to them. In particular, as shown in my Curriculum Vitae, I have been
`
`involved in indexing medical publications for many years, as well as employed as
`
`a librarian. I was also lead consultant for the American Medical Association’s
`
`AMA Manual of Style, 10th edition chapter 13, “Medical Indexes.”
`
`3.
`
`I understand that a reference is considered “prior art” in these
`
`proceedings if it is publicly accessible and can be located prior to a certain date
`
`using reasonable diligence by a hypothetical person referred to as the person of
`
`ordinary skill in the “art” (which I will refer to as a “POSA” herein) or field to
`
`2
`
`
`
`IPR2021-00406
`
`which the patent pertains. I further understand that the POSA for these
`
`proceedings would have an M.D. or a graduate degree (Masters or Ph.D.) in a field
`
`relating to drug development and at least two years practical experience in either
`
`(i) the investigation or treatment of pulmonary hypertension; or (ii) in the
`
`development of potential drug candidates, specifically in the delivery of drugs by
`
`inhalation. See Patent Owner Response, §3. A POSA may have had a lower level
`
`of formal education if such a person had more years of experience in the
`
`development of inhalable drugs. Id.
`
`4.
`
`I further believe that the POSA described above would regularly
`
`review literature about pharmaceutical sciences and drug delivery and would know
`
`how to carry out library research using basic library resources to find out more
`
`information about the areas being researched. Such a POSA typically would not,
`
`however, spend hundreds of hours scanning supplemental issues of a journal,
`
`paging through thousands of abstracts or the like, on the mere chance of finding
`
`something relevant to their work. The massive amount of time and effort involved
`
`in such searching would be well beyond the typical “diligent” effort I would expect
`
`the POSA described above to make.
`
`5.
`
`I have reviewed the Hall-Ellis Declaration and all of its attachments
`
`(Ex. 1036). I have also conducted searches of PubMed (maintained by the
`
`3
`
`
`
`IPR2021-00406
`
`National Library of Medicine, or “NLM”), Ovid, Chemical Abstracts, the
`
`American Heart Association Scientific Sessions, the Oxford University Press
`
`Medicine Archive, and WorldCat in connection with preparing this Declaration
`
`and reviewed certain other exhibits identified below.
`
`Document 1: Robert Voswinckel, et al., “Inhaled treprostinil sodium for the
`treatment of pulmonary hypertension,” Abstract #1414,
`Circulation, 110, 17, Supplement (October 2004): III-295
`(“Voswinckel JAHA”).
`The second reference discussed in the Hall-Ellis Declaration is
`
`6.
`
`Voswinckel JAHA, an abstract located in a 1,102-page supplement (“the
`
`Supplement”) to the journal Circulation in 2004 – specifically vol. 110, issue 17
`
`(Ex. 1008). The Supplement contains thousands of abstracts, with the Voswinckel
`
`abstract appearing on page III-295. Ex. 1008, 3. According to Dr. Hall-Ellis, the
`
`abstract stemmed from a meeting of the American Heart Association in New
`
`Orleans in November 2004. Ex. 1036, ¶59.
`
`7.
`
`Dr. Hall-Ellis opines that “the abstract ‘Pulmonary Arterial
`
`Hypertension: New Therapies’ by Voswinckel, et al. published in the Supplement
`
`to the journal Circulation was available in the Ebling Library for the Health
`
`Sciences at the University of Wisconsin – Madison (“UWML”) on November 26,
`
`2004.” Id., ¶61. As an initial matter, I note that Dr. Hall-Ellis does not quote the
`
`abstract title correctly (id.; see also id., ¶59). The abstract is titled, “Inhaled
`
`4
`
`
`
`IPR2021-00406
`
`treprostinil sodium for the treatment of pulmonary hypertension.” By way of
`
`contrast, the phrase “Pulmonary Arterial Hypertension: New Therapies” appears as
`
`a section heading on page III-295 of Exhibit 1008. When asked in her deposition
`
`about using this section heading instead of the actual article title, Dr. Hall-Ellis
`
`claimed that she used the section heading on purpose because she knew the
`
`researchers would find the article anyway. Ex. 2043, 213:24-214:5.
`
`8.
`
`I do not agree with Dr. Hall-Ellis’ use of the section heading to
`
`describe this abstract; the section heading is not the title of the abstract, as Dr.
`
`Hall-Ellis seems to suggest, and the section includes other abstracts in addition to
`
`the Voswinckel JAHA abstract. Furthermore, I disagree that Dr. Hall-Ellis has
`
`shown the public availability of the Voswinckel JAHA abstract as of the priority
`
`date, as further discussed below.
`
`A. Unlike Normal Journal Issues, Supplements of Circulation Are Not
`Routinely or Predictably Released, and Dr. Hall-Ellis Has Not Provided
`any Evidence of Receipt by a Library as of the Critical Date
`
`9.
`
`It is my opinion that Dr. Hall-Ellis has failed to show that either the
`
`Supplement or the Voswinckel JAHA abstract was disseminated in any predictable
`
`way such as to be accessible more than one year before the May 15, 2006 priority
`
`date—as evidenced by the fact that the Supplement and abstract continue to be
`
`difficult to access even today.
`
`5
`
`
`
`IPR2021-00406
`
`10. As previously stated, Voswinckel JAHA is one of thousands of
`
`abstracts contained in a 1,102-page supplement to the journal Circulation. For
`
`example, page 3 of Exhibit 1008 alone contains four abstracts and part of a fifth
`
`abstract, suggesting that the Supplement likely contains many thousands of
`
`abstracts. Unlike regular publications, supplements contain additional information
`
`not found in the regular journal issues, and they are released irregularly as
`
`compared to normal issues of a given journal. Publishers typically have the option
`
`of when to release supplements, if at all. Because it is unpredictable when
`
`additional information will become available and publishers have discretion when
`
`to release supplements, supplements are often not released on a routine basis or
`
`predictable schedule.
`
`11.
`
`This is particularly true for the Supplement containing Voswinckel
`
`JAHA. First, the title of the Supplement, Abstracts from Scientific Sessions 2004,
`
`suggests the Supplement was released in relation to the Scientific Sessions 2004
`
`Conference in November 2004. However, in my experience, it is not uncommon
`
`for supplements associated with conferences to be released well after the
`
`conference date because of the length of time associated with the peer-review
`
`process, printing, delivery, etc., all of which makes their publication date
`
`6
`
`
`
`IPR2021-00406
`
`unpredictable.1 Additionally, in my experience, delays in releasing abstract
`
`supplements associated with conferences in the medical field are common.
`
`Because the Supplement is an abstract supplement associated with a conference in
`
`the medical field, it would be very unsurprising if the release of the Supplement
`
`after the conference was significantly delayed.
`
`12.
`
`The American Heart Association online archive includes a list of the
`
`supplements to Circulation and their release dates, which I provide here as Exhibit
`
`2044.2 The dates listed in Exhibit 2044 show that the supplements are released on
`
`different days and in different months in any given year. Exhibit 2044 also shows
`
`that the Supplement containing Voswinckel JAHA does not appear in the
`
`American Heart Association online archives, despite other supplements being
`
`listed. Nor does the Supplement appear when the archives are searched using the
`
`term “treprostinil.” Therefore, any alleged publication frequency of the
`
`1 In 2017, for example, I participated in The Book Index symposium at Oxford
`
`University's Centre for the Study of the Book. The Proceedings have yet to be
`
`published. Delays in releasing abstract supplements associated with conferences in
`
`the medical field are similarly common.
`
`2 https://www.ahajournals.org/circ/supplements.
`
`7
`
`
`
`IPR2021-00406
`
`supplements (see, e.g., Ex. 1036, ¶61) is not a reliable indicator for determining
`
`whether and when the Supplement was accessible to the public.
`
`13. Dr. Hall-Ellis concludes that because of the publication frequency of
`
`the journal Circulation, the specific Supplement dated October 26, 2004, would
`
`have arrived to the UWML by November 26, 2004. However, this is an incorrect
`
`assumption. First, despite testifying that date-stamping of journal issues is a
`
`library “best practice” (id., ¶45), the copy of Voswinckel JAHA submitted in this
`
`proceeding (Ex. 1008; Ex. 1036, Attachment D) does not have any date-stamp
`
`showing when the Supplement was received by the library. During her deposition,
`
`Dr. Hall-Ellis could not explain the absence of a date-stamp. Ex. 2043,
`
`198:9-199:4. Nor did Dr. Hall-Ellis submit as evidence in this case any accession
`
`number3 for the Supplement, or a copy of the Supplement with a date stamp
`
`indicating actual receipt by a library.
`
`14. Second, the publication frequency described by Dr. Hall-Ellis refers to
`
`the entire journal Circulation, not the supplements, and therefore is irrelevant. The
`
`release dates of the Abstracts from Scientific Sessions supplements show they are
`
`3 An accession number is the unique number or code assigned to a work when it is
`
`added to a library collection.
`
`8
`
`
`
`IPR2021-00406
`
`not regularly published, if at all, each year. Ex. 2044. Finally, even if there was
`
`some predictable publication frequency for the supplements, Dr. Hall-Ellis
`
`admittedly has not provided any evidence showing that the Supplement was
`
`actually received by a library during that time. Ex. 2043, 157:6-158:1. As noted
`
`previously, I am personally aware of conference proceeding publications being
`
`delayed for years after the underlying event (supra, footnote 1), and a similar delay
`
`could easily have occurred here – certainly Dr. Hall-Ellis hasn’t shown otherwise.
`
`15. Moreover, even today, this Supplement is difficult to locate and
`
`access, whereas other supplements from the same period have since been digitized
`
`or uploaded. In fact, I personally have searched for this Supplement online, and
`
`have not been able to locate it. The Supplement is also not listed in the American
`
`Heart Association online archives.
`
`B. Neither the Supplement of Circulation Nor Individual Abstracts
`Therein Were Meaningfully Indexed as of the Critical Date, and Dr.
`Hall-Ellis Has Not Provided any Evidence of Such
`
`16.
`
`It is my opinion that Voswinckel JAHA was not publicly accessible
`
`before May 15, 2006 because neither the Supplement nor the abstracts within it
`
`were meaningfully indexed. For example, Dr. Hall-Ellis testified that the “510
`
`field” from the MARC record for a given journal indicates where articles from that
`
`journal are indexed. See Ex. 1036, ¶50. Dr. Hall-Ellis attached a MARC record
`
`9
`
`
`
`IPR2021-00406
`
`corresponding to the journal Circulation to her Declaration (id., Attachment D-5);
`
`the 510 field in this MARC record suggests that Circulation articles are indexed in
`
`Chemical Abstracts. However, I personally searched Chemical Abstracts Plus
`
`(“CAPlus”) and confirmed that the Voswinckel JAHA abstract is not indexed
`
`therein. See Ex. 2045.4 To the contrary, a search in CAPlus using the search terms
`
`“Voswinckel” and “treprostinil” shows that the oldest entry is from 2006, as shown
`
`by “2006:1023703” (id., 11), and none of the search results are materials from the
`
`Supplement. In addition, the search results that are returned consist exclusively of
`
`full-scale journal articles, rather than abstracts. This confirms that CAPlus (like
`
`other research databases, in my experience) does not include the abstracts that were
`
`published in the Supplement.
`
`17.
`
`Importantly, the same is true for all of the common databases Dr.
`
`Hall-Ellis identified as ones that a POSA would typically turn to. See Ex. 2043,
`
`41:1-42:4 (listing Ovid, PubMed, Index Medicus, and Chemical Abstracts as the
`
`relevant databases that a POSA would have used to search for art in the field as of
`
`4 The search results are returned as a “transcript,” and in this case there were 8 hits
`
`returned, none of which corresponded to Voswinckel JAHA.
`
`10
`
`
`
`IPR2021-00406
`
`2006). I personally searched Ovid, PubMed (which incorporates Index Medicus5),
`
`and CAPlus (which incorporates Chemical Abstracts), and the Voswinckel JAHA
`
`abstract cannot be found in any of them. Ex. 2046; Ex. 2047; Ex. 2045. This is
`
`strong evidence that the Voswinckel JAHA abstract was not meaningfully indexed
`
`such that it could have been located by an interested POSA through reasonable
`
`diligence, especially as of the 2006 critical date when many more modern
`
`databases did not exist or were in their infancy and contained fewer indexed
`
`holdings.
`
`18. Dr. Hall-Ellis asserts Voswinckel JAHA was meaningfully indexed in
`
`the UWML by May 15, 2006. Ex. 1036, ¶59. For support, Dr. Hall-Ellis points to
`
`Exhibit D to conclude that UWML indexed a physical copy of the Supplement
`
`containing Voswinckel JAHA. Id. Exhibit D appears to be a scanned image of a
`
`physical copy of the Supplement cover, introductory pages, and the abstract. Id.,
`
`Exhibit D. Notably, while a white sticker appears to be affixed to the cover, the
`
`cover page lacks any indication it was ever received by or located at the UWML.
`
`5 Index Medicus is no longer published. "It ran in print form until 2004. The
`
`National Library of Medicine's PubMed database now covers the publications that
`
`Index Medicus once covered, as well as many other publications."
`
`https://onlinebooks.library.upenn.edu/webbin/serial?id=indexmedicus.
`
`11
`
`
`
`IPR2021-00406
`
`There is also no “received” or “accepted” stamp anywhere on the cover, and there
`
`is no evidence of any “received” or “accepted” date.
`
`19.
`
`Dr. Hall-Ellis states that her opinion is based, in part, on finding a
`
`digital copy in the UWML, not the physical copy reproduced in the above image.
`
`See id., ¶¶59-61. However, Exhibit 2040 introduced during the Hall-Ellis
`
`Deposition indicates the UWML does not have physical copies of this Supplement.
`
`See Ex. 2040, 2 (showing physical holdings only of supplement volumes 114 and
`
`12
`
`
`
`IPR2021-00406
`
`116, and not the volume 110 at issue here). It is also my understanding that on
`
`November 26, 2004, the UWML would not have maintained a digital copy as it
`
`was not common library practice at the time. Consequently, because Dr. Hall-Ellis
`
`admitted that Exhibit D is a scanned image of a physical paper copy, there is no
`
`evidence indicating from where Exhibit D originated. In my experience, it is
`
`common practice for libraries to record when specific issues of serial publications
`
`are received. Given the absence of such evidence here, even if the UWML
`
`received copies of the journal Circulation in print at some point in the past, there is
`
`no evidence showing that this particular Supplement was ever received by the
`
`UWML.
`
`20. Dr. Hall-Ellis claims the MARC record in her Attachment D-1 shows
`
`the UWML’s ownership of the journal Circulation (Ex. 1036, ¶60), but the
`
`UWML’s code (uwmadisondb) corresponds to a digital copy, not the image of a
`
`physical copy as provided in Exhibit D. And like the rest of the Hall-Ellis
`
`Declaration dealing with abstracts, this MARC record is for the entire Circulation
`
`journal, not the particular Supplement and certainly not for the abstract itself.
`
`21.
`
`It is my opinion that Attachment D-1 (or other MARC records like it)
`
`would not enable a POSA to locate the Supplement, and particularly not the
`
`Voswinckel JAHA abstract. It provides no meaningful way to find or search for
`
`13
`
`
`
`IPR2021-00406
`
`neither supplements to this journal, nor individual abstracts published in any
`
`supplements. The MARC record does not indicate when the catalogue record was
`
`created, nor is there any reason provided by Dr. Hall-Ellis to believe this MARC
`
`record as produced in Attachment D-1 existed in the 2004-2006 timeframe, at least
`
`certainly not in the form that Dr. Hall-Ellis attaches to her declaration. See Ex.
`
`2043, 127:1-21.
`
`22.
`
`The remaining MARC and Library of Congress records (Ex. 1036,
`
`Attachments D-1–D-4 and D-6–D-9) also fail to provide a meaningful way to find
`
`or search for either the Supplement or the Voswinckel JAHA abstract itself. Dr.
`
`Hall-Ellis relies on subject matter fields in these records to demonstrate that the
`
`overall journal Circulation was indexed. See Ex. 1036, ¶¶60-64. However, those
`
`fields list the call numbers corresponding to how the journal Circulation is
`
`catalogued by various libraries. The 050 field lists the Library of Congress (LOC)
`
`call number RC681.A1, the 060 field is the National Library of Medicine (NLM)
`
`call number, and the 082 field is the Dewey Decimal Classification (DDC) number
`
`(for all other libraries). See id., Attachment D1, D5. However, these fields for the
`
`journal Circulation do nothing to tell researchers that the Supplement exists, when
`
`the Supplement was accessible, or what the Supplement contains.
`
`14
`
`
`
`IPR2021-00406
`
`23. Dr. Hall-Ellis testified that the MARC records also show that the
`
`journal Circulation was catalogued with the two descriptor terms “Cardiology $x
`
`Societies” and “Heart $x Diseases $v Periodicals.” Ex. 1036, ¶64. However,
`
`neither of these descriptor terms would provide any meaningful assistance in
`
`locating the Voswinckel JAHA abstract. Once again, these descriptor terms
`
`correspond to the entire journal Circulation, not the Supplement or the Voswinckel
`
`JAHA abstract itself.
`
`24.
`
`In addition, the descriptor terms are extremely broad. To illustrate
`
`this point, I performed a search for titles from 1971 to 2006 in WorldCat, Ovid,
`
`and PubMed using the terms “Cardiology”, “Heart Diseases, Periodicals”, and
`
`“Heart Diseases”.6 The table below shows that in WorldCat, for example,
`
`“Cardiology” produced 484,921 results, and “Heart Diseases, Periodicals”
`
`produced 837 results. These search results represent entire periodicals, each of
`
`which might have thousands of issues, each of which in turn might have multiple
`
`articles of interest or thousands of abstracts, as with the Supplement at issue here.
`
`Copies of my search results are attached hereto as Exhibit 2048. After searching
`
`with these terms, a POSA would have had to locate the journal Circulation within
`
`6 Both Ovid and PubMed are limited to content from periodicals, so the search was
`
`limited to just “Heart Diseases” in these databases.
`
`15
`
`
`
`IPR2021-00406
`
`the voluminous search results. Such search results would include every issue of
`
`Circulation since it started publication in 1950, and, as noted above, would not
`
`necessarily show the Supplement. Even if a POSA were to somehow then find the
`
`Supplement, the abstract would still be exceedingly difficult to locate because the
`
`Voswinckel JAHA abstract is only one of many thousands of abstracts in the
`
`1,102-page Supplement.
`
`Database
`
`Search Term (1971-2006) Number of Search
`Results
`
`WorldCat
`
`Ovid
`
`PubMed
`
`“Cardiology”
`
`484,921
`
`“Heart Disease, Periodicals”
`
`837
`
`“Cardiology”
`
`“Heart Disease”
`
`“Cardiology”
`
`“Heart Disease”
`
`39,392
`
`3,748
`
`9,837
`
`60,376
`
`25. Dr. Hall-Ellis has not provided any evidence of even so much as a
`
`table of contents in the Supplement, meaning that a POSA would literally have to
`
`flip through the 1102-page Supplement page by page looking for abstracts of
`
`16
`
`
`
`IPR2021-00406
`
`interest. In my opinion, a POSA conducting diligent research would not sift
`
`through such voluminous results – Dr. Hall-Ellis agrees.7, 8
`
`26.
`
`Lastly, Dr. Hall-Ellis states that the Supplement is indexed by topic,
`
`stating that “one of those topics is the ‘Pulmonary Arterial Hypertension: New
`
`Therapies.’” Ex. 1036, ¶67. However, there is no evidence that this topic appears
`
`in any index or could be located by a POSA other than by flipping through the
`
`Supplement page by page and coming to page III-295. As I stated previously, this
`
`topic is actually a section heading in the massive listing of abstracts (supra, ¶7).
`
`Even if this section heading were considered an index entry of some sort, it does
`
`not meaningfully direct a POSA to Voswinckel JAHA because there is no way to
`
`find it except by going through the Supplement page by page.
`
`27.
`
`In sum, Dr. Hall-Ellis has provided little more than general
`
`information about the journal Circulation as a whole. Dr. Hall-Ellis provides no
`
`7 “Research and information science suggests that people no longer look longer
`
`than three screens.” Ex. 2043, 88:7-9.
`
`8 Dr. Hall-Ellis apparently assumes (improperly) that a POSA would know of the
`
`abstract’s existence prior to searching for Voswinckel JAHA. See Ex. 2043,
`
`165:10-22; 167:3-18.
`
`17
`
`
`
`IPR2021-00406
`
`evidence that the Supplement containing Voswinckel JAHA was ever received by
`
`a library as of the priority date. And even if it were, there is also no evidence that
`
`any meaningful indexing of the Supplement or the Voswinckel JAHA abstract ever
`
`occurred or, if it has been done, when it occurred. My own research suggests that
`
`the Supplement and the Voswinckel JAHA abstract have not been meaningfully
`
`indexed, as evidenced by their lack of appearance in all of the databases that Dr.
`
`Hall-Ellis admits a POSA would turn to. Supra, ¶17; Ex. 2043, 41:1-42:4. Based
`
`on the above, it is my opinion that the Voswinckel JAHA abstract was neither
`
`disseminated nor available such that a POSA exercising reasonable diligence could
`
`have located the Voswinckel JAHA abstract before May 15, 2006.
`
`Document 2: Robert Voswinckel, et al., “Inhaled treprostinil is a potent
`pulmonary vasodilator in severe pulmonary hypertension,”
`Abstract #218, European Heart Journal 25:22, Abstract
`Supplement (2004) (“Voswinckel JESC”).
`
`28. Another reference discussed in the Hall-Ellis Declaration beginning in
`
`paragraph 68 is Voswinckel JESC, an abstract within a supplement to the
`
`European Heart Journal in 2004 – specifically vol. 25 (the “EHJ Supplement”).
`
`Ex. 1007, cover. The EHJ Supplement contains 3,850 abstracts spanning more
`
`than 700 pages (id., 6), with the Voswinckel JESC abstract appearing as abstract
`
`218 (id., 7). The EHJ Supplement appears to be associated with the European
`
`Society of Cardiology (“ESC”) Conference. Id., cover.
`
`18
`
`
`
`IPR2021-00406
`
`A. Unlike Normal Journal Issues, Supplements of the European Heart
`Journal Are Not Routinely or Predictably Released, and Dr. Hall-Ellis
`Has Not Provided any Evidence of Receipt by a Library as of the
`Critical Date
`
`29.
`
`Like the Voswinckel JAHA abstract, it is my opinion that Dr. Hall-
`
`Ellis has failed to show that either the EHJ Supplement or the Voswinckel JESC
`
`abstract was disseminated in any predictable way such as to be accessible more
`
`than one year before the May 15, 2006 priority date—as evidenced by the fact that
`
`the EHJ Supplement and Voswinckel JESC abstract continue to be difficult to
`
`access even today.
`
`30. As previously stated, Voswinckel JESC is one of 3,850 abstracts
`
`spanning more than 700 pages in the EHJ Supplement to the European Heart
`
`Journal. Unlike regular publications, supplements contain additional information
`
`not found in the regular journal issues and they are released irregularly as
`
`compared to normal issues of a given journal. Publishers typically have the option
`
`of when to release supplements, if at all. Because it is unpredictable when
`
`additional information will become available and publishers have discretion when
`
`to release supplements, supplements may not be released on a routine basis or
`
`predictable schedule.
`
`31.
`
`This is particularly true for the EHJ Supplement containing
`
`Voswinckel JESC. First, the cover of the EHJ Supplement suggests the EHJ
`
`19
`
`
`
`IPR2021-00406
`
`Supplement was released in relation to the European Society of Cardiology
`
`Conference held in the fall of 2004. Ex. 1007, cover. However, in my experience,
`
`it is not uncommon for abstract supplements associated with conferences to be
`
`released well after the conference date because of the length of time associated
`
`with the peer-review process, printing, delivery, etc., all of which makes their
`
`publication date unpredictable.9 As previously stated, in my experience, delays in
`
`releasing supplements associated with conferences in the medical field are
`
`common. Because the EHJ Supplement is an abstract supplement associated with
`
`a conference in the medical field, significant delays in releasing the EHJ
`
`Supplement after the conference are quite possible.
`
`32.
`
`The European Heart Journal online archive10 includes a list of the
`
`supplements to the European Heart Journal and their release dates, which I attach
`
`here as Exhibit 2049. The dates listed in Exhibit 2049 show that the supplements
`
`are released on different days and in different months in any given year. Exhibit
`
`2049 also shows that the EHJ Supplement containing Voswinckel JESC does not
`
`appear in the European Heart Journal online archives, despite other supplements
`
`being listed. Therefore, any alleged publication frequency of the supplements (see,
`
`9 See supra, footnote 1.
`
`10 https://academic.oup.com/eurheartj/supplements.
`
`20
`
`
`
`IPR2021-00406
`
`e.g., Ex. 1036, ¶70) is not a reliable indicator for determining whether the EHJ
`
`Supplement was actually accessible at that time (or even now).
`
`33. Dr. Hall-Ellis concludes that because of publication frequency of the
`
`European Heart Journal, the EHJ Supplement dated August/September 2004,
`
`would have arrived at the University of Iowa Library by October 31, 2004.11 Id.
`
`However, this is an incorrect assumption. First, the publication frequency
`
`described by Dr. Hall-Ellis refers to the entire European Heart Journal, not the
`
`EHJ Supplement. Second, the release dates of the ESC conference supplements
`
`show they are not regularly published, if at all, each year. Finally, even if there
`
`was some predictable publication frequency for the supplements, Dr. Hall-Ellis
`
`admittedly has not provided any evidence showing that the EHJ Supplement was
`
`actually received by a library before the 2006 priority date at issue here.12
`
`11 Q: “So you don't know the publication frequency for the abstract supplements
`
`for this journal, correct?” A: “No.” Ex. 2043, 234:9-11.
`
`12 “Just to be complete, let me ask, does Exhibit E anywhere else in that exhibit
`
`give an indication of when it was received by the University of Iowa Library?” A:
`
`“No.” Ex. 2043, 222:4-8.
`
`21
`
`
`
`IPR2021-00406
`
`B. Neither the EHJ Supplement Nor Individual Abstracts Therein Were
`Meaningfully Indexed as of the Critical Date, and Dr. Hall-Ellis Has
`Not Provided any Evidence of Such
`
`34.
`
`Like the Voswinckel JAHA abstract, Dr. Hall-Ellis relies on a digital
`
`copy from the University of Iowa Library rather than locating a physical copy to
`
`allegedly show the EHJ Supplement was available at the University of Iowa
`
`Library system by the priority date. Further, Dr. Hall-Ellis similarly, and
`
`incorrectly, relies on the MARC and Library of Congress records to show the
`
`Voswinckel JESC abstract was available at the University of Iowa Library system
`
`by the priority date. However, the same issues with the Voswinckel JAHA abstract
`
`are present with the Voswinckel JESC abstract.
`
`35.
`
`For example, Dr. Hall-Ellis identified the MARC catalog records
`
`corresponding to the entire European Heart Journal as alleged evidence that the
`
`EHJ Supplement (and the Voswinckel JESC abstract) were located at the
`
`University of Iowa Library by the priority date, but the cited evidence does not
`
`support her conclusions for the same reasons I have already discussed. See supra,
`
`¶¶16-17, 19-25. Additionally, Dr. Hall-Ellis identifies general descriptor terms for
`
`the entire European Heart Journal rather than the EHJ Supplement or the
`
`Voswinckel JESC abstract, which would produce from thousands up to hundreds
`
`of thousands of search results that would include every issue of the European
`
`22
`
`
`
`IPR2021-00406
`
`Heart Journal since it started publication about 40 years ago,13 and would not
`
`necessarily show the EHJ Supplement, just as I described previously. See supra,
`
`¶24.
`
`36. Dr. Hall-Ellis contends that the EHJ Supplement contains a table of
`
`contents, indexed by topic. Ex. 1036, ¶76. However, even with the EHJ
`
`Supplement table of contents, a POSA exercising reasonable diligence still would
`
`not have been able to easily find the Voswinckel JESC abstract because this “table
`
`of contents” in the EHJ Supplement lacks a meaningful topic index. Like the
`
`Supplement containing the Voswinckel JAHA abstract, a POSA would have to
`
`obtain an entire copy of the EHJ Supplement and then flip through it page by page
`
`in order to find the Voswinckel JESC abstract.
`
`37. However, like the Supplement containing the Voswinckel JAHA
`
`abstract, the EHJ Supplement and the Voswinckel JESC abstract are similarly
`
`difficult to locate. The EHJ Supplement is not indexed in Ovid, PubMed, or
`
`CAPlus, all of which are common databases for clinical research and POSAs. In
`
`13 Vol. 1, Issue 1 of the European Heart Journal is dated February 1980.
`
`https://academic.oup.com/eurheartj/issue/1/1.
`
`23
`
`
`
`IPR2021-00406
`
`fact, Dr. Hall-Ellis admitted she, too, had not located the Voswinckel JESC
`
`abstract in these databases. See Ex. 2043, 243:12-18.
`
`38.
`
`In sum, Dr. Hall-Ellis has provided little more than general
`
`information about the European Heart Journal as a whole. Dr. Hall-Ellis provides
`
`no evidence that the EHJ Supplement containing Voswinckel JESC was ever
`
`received by a library as of the priority date. And even if it were, there is also no
`
`evidence that any meaningful indexing of the EHJ Supplement or the Voswinckel
`
`JESC abstract ever occurred or, if it has been done, when it occurred. My own
`
`research suggests that the EHJ Supplement and the Voswinckel JESC abstract have
`
`not been meaningfully indexed, as evidenced by their lack of appearance in the
`
`databases that Dr. Hall-Ellis admits a POSA would turn to. See supra, ¶17; Ex.
`
`2043, 41:1-42:4. Based on the above, it is my opinion that the Voswinckel JESC
`
`abstract was neither disseminated nor available such that a POSA exercising
`
`reasonable diligence could have located the Voswinckel JESC abstract before May
`
`15, 2006.
`
`39.
`
`I hereby declare that all statements made herein of my knowledge are
`
`true and that all statements made on information and belief are believed to be true;
`
`and further that these statements were made with the knowledge that willful false
`
`24
`
`
`
`IPR2021-00406
`
`
`
`statements and the like so made are punishable by fine or imprisonment, or both
`
`
`
`
`
`
`
`under Section 1001 of Title 18 of the United States Code.
`
`
`
`, 2021
`
`25
`
`
Accessing this document will incur an additional charge of $.
After purchase, you can access this document again without charge.
Accept $ Charge
Still Working On It
This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.
Give it another minute or two to complete, and then try the refresh button.
A few More Minutes ... Still Working
It can take up to 5 minutes for us to download a document if the court servers are running slowly.
Thank you for your continued patience.
This document could not be displayed.
We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.
Your account does not support viewing this document.
You need a Paid Account to view this document. Click here to change your account type.
Your account does not support viewing this document.
Set your membership
status to view this document.
With a Docket Alarm membership, you'll
get a whole lot more, including:
- Up-to-date information for this case.
- Email alerts whenever there is an update.
- Full text search for other cases.
- Get email alerts whenever a new case matches your search.
One Moment Please
The filing “” is large (MB) and is being downloaded.
Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.
Your document is on its way!
If you do not receive the document in five minutes, contact support at support@docketalarm.com.
Sealed Document
We are unable to display this document, it may be under a court ordered seal.
If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.
Access Government Site
