IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`COALITION FOR AFFORDABLE DRUGS X LLC,
`Petitioner,
`
`v.
`
`ANACOR PHARMACEUTICALS, INC.,
`Patent Owner.
`
`Case No. IPR2015-01776
`Patent No. 7,582,621
`
`
`
`PETITIONER’S OBJECTIONS TO PATENT OWNER’S EVIDENCE
`UNDER 37 C.F.R. § 42.64(B)(1)
`
`
`
`
`
`
`
`
`
`1
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`COALITION FOR AFFORDABLE DRUGS X LLC,
`Petitioner,
`
`v.
`
`ANACOR PHARMACEUTICALS, INC.,
`Patent Owner.
`
`Case No. IPR2015-01776
`Patent No. 7,582,621
`
`
`
`PETITIONER’S OBJECTIONS TO PATENT OWNER’S EVIDENCE
`UNDER 37 C.F.R. § 42.64(B)(1)
`
`
`
`
`
`
`
`
`
`1
`
`
`
`
`
`Coalition for Affordable drugs X LLC (“Petitioner”) submits the following
`
`objections to evidence served by Anacor Pharmaceuticals, Inc. (“Patent Owner”)
`
`with its Patent Owner Response. These objections are timely filed within five (5)
`
`business days from service of the evidence.
`
`
`
`Petitioner reserves the right to present further objection to these or
`
`additional Exhibits submitted by Patent Owner, as allowed by the applicable rules
`
`or authority.
`
`
`
`The following table identifies Petitioner’s objections to the respective
`
`exhibits. The alleged evidence presented in the respective exhibits are
`
`inadmissible for at least the reasons presented in the right-hand column of the
`
`table below.
`
`Exhibit
`
`No.
`
`Objection(s)
`
`2001
`
`FRE 401/402: The label for KERYDIN is irrelevant to the
`
`patentability of the claims at issue.
`
`
`
`FRE 703: This exhibit is cited in an expert declaration. The expert
`
`declarations, however, do not establish that this exhibit includes the
`
`type of facts or data that would normally be reasonably relied on by
`
`
`
`2
`
`
`
`experts in the particular field. Thus, this exhibit and any paragraph in
`
`the expert declarations citing to this exhibit are inadmissible under
`
`FRE 703. Further, Patent Owners have also failed to establish that this
`
`exhibit’s probative value substantially outweighs any prejudicial
`
`effect. As such, this exhibit is inadmissible as evidence to be
`
`presented to the Board under FRE 703.
`
`
`
`FRE 802: This exhibit is being used as inadmissible hearsay. In the
`
`Patent Owner Response, the Patent Owner merely repeats a statement
`
`from this exhibit for the truth of the statement. (Patent Owner
`
`Response, at 10 (“KERYDIN is ‘indicated for the topical treatment of
`
`onychomycosis of the toenails due to Trichophyton rubrum or
`
`Trichophyton mentagrophytes.’”).)
`
`
`
`FRE 901: This exhibit lacks authentication. There is no evidence
`
`supporting where this exhibit was retrieved or how it was retrieved,
`
`nor is it addressed in the Declaration of Jennifer Augsburger (Ex.
`
`2102).
`
`FRE 703: This exhibit is cited in an expert declaration. The expert
`
`declarations, however, do not establish that this exhibit includes the
`
`3
`
`2002
`
`
`
`
`
`type of facts or data that would normally be reasonably relied on by
`
`experts in the particular field. Thus, this exhibit and any paragraph in
`
`the expert declarations citing to this exhibit are inadmissible under
`
`FRE 703. Further, Patent Owners have also failed to establish that this
`
`exhibit’s probative value substantially outweighs any prejudicial
`
`effect. As such, this exhibit is inadmissible as evidence to be
`
`presented to the Board under FRE 703.
`
`
`
`FRE 802: This exhibit is being used as inadmissible hearsay for the
`
`contention that boron is toxic. (See Response, at 15.)
`
`FRE 401/402: This exhibit is inadmissible as lacking relevance. The
`
`Patent Owner does not cite this exhibit at any point in its Patent Owner
`
`2003
`
`Response or in any of the expert declarations (i.e., Exs. 2034-2037).1
`
`
`
`FRE 802: This exhibit contains hearsay. Because this exhibit is not
`
`
`1 This statement and similar statements for relevancy objections are based on an
`
`electronic word search for the exhibit number in the documents as filed with the
`
`USPTO. Should these exhibits actually be cited in the identified documents,
`
`Petitioners respectfully request identification of the citations.
`
`
`
`4
`
`
`
`cited in the Patent Owner Response, it is unclear how this exhibit is
`
`intended to be used. As such, Petitioner’s object to any use of this
`
`exhibit as hearsay.
`
`FRE 703: This exhibit is cited in an expert declaration. The expert
`
`declarations, however, do not establish that this exhibit includes the
`
`type of facts or data that would normally be reasonably relied on by
`
`experts in the particular field. Thus, this exhibit and any paragraph in
`
`the expert declarations citing to this exhibit are inadmissible under
`
`FRE 703. Further, Patent Owners have also failed to establish that this
`
`exhibit’s probative value substantially outweighs any prejudicial
`
`effect. As such, this exhibit is inadmissible as evidence to be
`
`presented to the Board under FRE 703.
`
`
`
`2004
`
`FRE 802: This exhibit is being used as inadmissible hearsay for the
`
`contention that boron is toxic. (See Response, at 13-14.)
`
`FRE 703: This exhibit is cited in an expert declaration. The expert
`
`declarations, however, do not establish that this exhibit includes the
`
`2005
`
`type of facts or data that would normally be reasonably relied on by
`
`experts in the particular field. Thus, this exhibit and any paragraph in
`
`the expert declarations citing to this exhibit are inadmissible under
`
`
`
`5
`
`
`
`FRE 703. Further, Patent Owners have also failed to establish that this
`
`exhibit’s probative value substantially outweighs any prejudicial
`
`effect. As such, this exhibit is inadmissible as evidence to be
`
`presented to the Board under FRE 703.
`
`
`
`FRE 802: This exhibit is being used as inadmissible hearsay for the
`
`contention that boron is toxic. (See Response, at 13-14.)
`
`FRE 401/402: This exhibit is inadmissible as lacking relevance. The
`
`Patent Owner does not cite this exhibit at any point in its Patent Owner
`
`Response or in any of the expert declarations (i.e., Exs. 2034-2037).
`
`
`
`FRE 802: This exhibit contains hearsay. Because this exhibit is not
`
`cited in the Patent Owner Response, it is unclear how this exhibit is
`
`2006
`
`intended to be used. As such, Petitioner’s object to any use of this
`
`exhibit as hearsay.
`
`
`
`FRE 901: This exhibit lacks proper authentication. Patent Owner has
`
`not produced evidence establishing from where or how this document
`
`was retrieved.
`
`
`
`6
`
`
`
`FRE 703: This exhibit is cited in an expert declaration. The expert
`
`declarations, however, do not establish that this exhibit includes the
`
`type of facts or data that would normally be reasonably relied on by
`
`experts in the particular field. Thus, this exhibit and any paragraph in
`
`the expert declarations citing to this exhibit are inadmissible under
`
`FRE 703. Further, Patent Owners have also failed to establish that this
`
`exhibit’s probative value substantially outweighs any prejudicial
`
`effect. As such, this exhibit is inadmissible as evidence to be
`
`2007
`
`presented to the Board under FRE 703.
`
`
`
`FRE 802: This exhibit is being used as inadmissible hearsay for the
`
`contention that boron is toxic. (See Response, at 13-14.)
`
`FRE 703: This exhibit is cited in an expert declaration. The expert
`
`declarations, however, do not establish that this exhibit includes the
`
`type of facts or data that would normally be reasonably relied on by
`
`2008
`
`experts in the particular field. Thus, this exhibit and any paragraph in
`
`the expert declarations citing to this exhibit are inadmissible under
`
`FRE 703. Further, Patent Owners have also failed to establish that this
`
`exhibit’s probative value substantially outweighs any prejudicial
`
`effect. As such, this exhibit is inadmissible as evidence to be
`
`
`
`7
`
`
`
`presented to the Board under FRE 703.
`
`
`
`FRE 802: This exhibit is being used as inadmissible hearsay for the
`
`contention that boron is toxic. (See Response, at 13-14.)
`
`FRE 703: This exhibit is cited in an expert declaration. The expert
`
`declarations, however, do not establish that this exhibit includes the
`
`type of facts or data that would normally be reasonably relied on by
`
`experts in the particular field. Thus, this exhibit and any paragraph in
`
`the expert declarations citing to this exhibit are inadmissible under
`
`FRE 703. Further, Patent Owners have also failed to establish that this
`
`exhibit’s probative value substantially outweighs any prejudicial
`
`effect. As such, this exhibit is inadmissible as evidence to be
`
`2009
`
`presented to the Board under FRE 703.
`
`
`
`FRE 802: This exhibit is being used as inadmissible hearsay for the
`
`contention that boron is toxic. (See Response, at 13-14.)
`
`FRE 703: This exhibit is cited in an expert declaration. The expert
`
`declarations, however, do not establish that this exhibit includes the
`
`type of facts or data that would normally be reasonably relied on by
`
`experts in the particular field. Thus, this exhibit and any paragraph in
`
`8
`
`2010
`
`
`
`
`
`the expert declarations citing to this exhibit are inadmissible under
`
`FRE 703. Further, Patent Owners have also failed to establish that this
`
`exhibit’s probative value substantially outweighs any prejudicial
`
`effect. As such, this exhibit is inadmissible as evidence to be
`
`presented to the Board under FRE 703.
`
`
`
`FRE 802: This exhibit is being used as inadmissible hearsay for the
`
`contention that boron is toxic. (See Response, at 13-14.)
`
`FRE 703: This exhibit is cited in an expert declaration. The expert
`
`declarations, however, do not establish that this exhibit includes the
`
`type of facts or data that would normally be reasonably relied on by
`
`experts in the particular field. Thus, this exhibit and any paragraph in
`
`the expert declarations citing to this exhibit are inadmissible under
`
`FRE 703. Further, Patent Owners have also failed to establish that this
`
`exhibit’s probative value substantially outweighs any prejudicial
`
`effect. As such, this exhibit is inadmissible as evidence to be
`
`2011
`
`presented to the Board under FRE 703.
`
`
`
`FRE 802: This exhibit is being used as inadmissible hearsay for the
`
`contention that boron is toxic. (See Response, at 13-14.)
`
`
`
`9
`
`
`
`FRE 703: This exhibit is cited in an expert declaration. The expert
`
`declarations, however, do not establish that this exhibit includes the
`
`type of facts or data that would normally be reasonably relied on by
`
`experts in the particular field. Thus, this exhibit and any paragraph in
`
`the expert declarations citing to this exhibit are inadmissible under
`
`FRE 703. Further, Patent Owners have also failed to establish that this
`
`exhibit’s probative value substantially outweighs any prejudicial
`
`effect. As such, this exhibit is inadmissible as evidence to be
`
`presented to the Board under FRE 703.
`
`
`
`FRE 802: This exhibit is being used as inadmissible hearsay for the
`
`contention that boron is toxic. (See Response, at 13-14.)
`
`FRE 401/402: This exhibit is inadmissible as lacking relevance. The
`
`Patent Owner does not cite this exhibit at any point in its Patent Owner
`
`Response or in any of the expert declarations (i.e., Exs. 2034-2037).
`
`
`
`FRE 802: This exhibit contains hearsay. Because this exhibit is not
`
`cited in the Patent Owner Response, it is unclear how this exhibit is
`
`intended to be used. As such, Petitioner’s object to any use of this
`
`2012
`
`2013
`
`exhibit as hearsay.
`
`
`
`10
`
`
`
`2016
`
`2017
`
`FRE 401/402: This exhibit is inadmissible as lacking relevance. The
`
`Patent Owner does not cite this exhibit at any point in its Patent Owner
`
`Response or in any of the expert declarations (i.e., Exs. 2034-2037).
`
`
`
`FRE 802: This exhibit contains hearsay. Because this exhibit is not
`
`cited in the Patent Owner Response, it is unclear how this exhibit is
`
`intended to be used. As such, Petitioner’s object to any use of this
`
`exhibit as hearsay.
`
`FRE 703: This exhibit is cited in an expert declaration. The expert
`
`declarations, however, do not establish that this exhibit includes the
`
`type of facts or data that would normally be reasonably relied on by
`
`experts in the particular field. Thus, this exhibit and any paragraph in
`
`the expert declarations citing to this exhibit are inadmissible under
`
`FRE 703. Further, Patent Owners have also failed to establish that this
`
`exhibit’s probative value substantially outweighs any prejudicial
`
`effect. As such, this exhibit is inadmissible as evidence to be
`
`presented to the Board under FRE 703.
`
`
`
`FRE 802: This exhibit is being used as inadmissible hearsay for the
`
`contention that topical application of boric acid may be fatal. (See
`
`
`
`11
`
`
`
`Response, at 13-14.)
`
`FRE 401/402: This exhibit is inadmissible as lacking relevance. The
`
`Patent Owner does not cite this exhibit at any point in its Patent Owner
`
`Response or in any of the expert declarations (i.e., Exs. 2034-2037).
`
`
`
`FRE 802: This exhibit contains hearsay. Because this exhibit is not
`
`cited in the Patent Owner Response, it is unclear how this exhibit is
`
`intended to be used. As such, Petitioner’s object to any use of this
`
`exhibit as hearsay.
`
`FRE 401/402: This exhibit is inadmissible as lacking relevance. The
`
`Patent Owner does not cite this exhibit at any point in its Patent Owner
`
`Response or in any of the expert declarations (i.e., Exs. 2034-2037).
`
`
`
`FRE 802: This exhibit contains hearsay. Because this exhibit is not
`
`cited in the Patent Owner Response, it is unclear how this exhibit is
`
`intended to be used. As such, Petitioner’s object to any use of this
`
`exhibit as hearsay.
`
`2018
`
`2019
`
`FRE 401/402: This exhibit is inadmissible as lacking relevance. The
`
`2020
`
`Patent Owner does not cite this exhibit at any point in its Patent Owner
`
`Response.
`
`
`
`12
`
`
`
`
`
`FRE 802: This exhibit contains hearsay. Because this exhibit is not
`
`cited in the Patent Owner Response, it is unclear how this exhibit is
`
`intended to be used. As such, Petitioner’s object to any use of this
`
`exhibit as hearsay.
`
`
`
`FRE 703: This exhibit is cited only in an expert declaration. The
`
`expert declarations, however, do not establish that this exhibit includes
`
`the type of facts or data that would normally be reasonably relied on
`
`by experts in the particular field. Thus, this exhibit and any paragraph
`
`in the expert declarations citing to this exhibit are inadmissible under
`
`FRE 703. Further, Patent Owners have also failed to establish that this
`
`exhibit’s probative value substantially outweighs any prejudicial
`
`effect. Indeed, the omission of any citation to this exhibit in the Patent
`
`Owner’s Response suggests that Patent Owner believes that this
`
`exhibit has little if any probative value. As such, this exhibit is
`
`inadmissible as evidence to be presented to the Board under FRE 703.
`
`FRE 401/402: This exhibit is inadmissible as lacking relevance. The
`
`2021
`
`Patent Owner does not cite this exhibit at any point in its Patent Owner
`
`Response.
`
`
`
`13
`
`
`
`
`
`FRE 802: This exhibit contains hearsay. Because this exhibit is not
`
`cited in the Patent Owner Response, it is unclear how this exhibit is
`
`intended to be used. As such, Petitioner’s object to any use of this
`
`exhibit as hearsay.
`
`
`
`FRE 703: This exhibit is cited only in an expert declaration. The
`
`expert declarations, however, do not establish that this exhibit includes
`
`the type of facts or data that would normally be reasonably relied on
`
`by experts in the particular field. Thus, this exhibit and any paragraph
`
`in the expert declarations citing to this exhibit are inadmissible under
`
`FRE 703. Further, Patent Owners have also failed to establish that this
`
`exhibit’s probative value substantially outweighs any prejudicial
`
`effect. Indeed, the omission of any citation to this exhibit in the Patent
`
`Owner’s Response suggests that Patent Owner believes that this
`
`exhibit has little if any probative value. As such, this exhibit is
`
`inadmissible as evidence to be presented to the Board under FRE 703.
`
`FRE 401/402: This exhibit is inadmissible as lacking relevance. The
`
`2022
`
`Patent Owner does not cite this exhibit at any point in its Patent Owner
`
`Response.
`
`
`
`14
`
`
`
`
`
`FRE 802: This exhibit contains hearsay. Because this exhibit is not
`
`cited in the Patent Owner Response, it is unclear how this exhibit is
`
`intended to be used. As such, Petitioner’s object to any use of this
`
`exhibit as hearsay.
`
`
`
`FRE 703: This exhibit is cited only in an expert declaration. The
`
`expert declarations, however, do not establish that this exhibit includes
`
`the type of facts or data that would normally be reasonably relied on
`
`by experts in the particular field. Thus, this exhibit and any paragraph
`
`in the expert declarations citing to this exhibit are inadmissible under
`
`FRE 703. Further, Patent Owners have also failed to establish that this
`
`exhibit’s probative value substantially outweighs any prejudicial
`
`effect. Indeed, the omission of any citation to this exhibit in the Patent
`
`Owner’s Response suggests that Patent Owner believes that this
`
`exhibit has little if any probative value. As such, this exhibit is
`
`inadmissible as evidence to be presented to the Board under FRE 703.
`
`FRE 401/402: This exhibit is inadmissible as lacking relevance. The
`
`2023
`
`Patent Owner does not cite this exhibit at any point in its Patent Owner
`
`Response or in any of the expert declarations (i.e., Exs. 2034-2037).
`
`
`
`15
`
`
`
`
`
`FRE 802: This exhibit contains hearsay. Because this exhibit is not
`
`cited in the Patent Owner Response, it is unclear how this exhibit is
`
`intended to be used. As such, Petitioner’s object to any use of this
`
`exhibit as hearsay.
`
`FRE 401/402: This exhibit is inadmissible as lacking relevance. The
`
`Patent Owner does not cite this exhibit at any point in its Patent Owner
`
`Response or in any of the expert declarations (i.e., Exs. 2034-2037).
`
`
`
`FRE 802: This exhibit contains hearsay. Because this exhibit is not
`
`cited in the Patent Owner Response, it is unclear how this exhibit is
`
`intended to be used. As such, Petitioner’s object to any use of this
`
`exhibit as hearsay.
`
`FRE 401/402: This exhibit is inadmissible as lacking relevance. The
`
`Patent Owner does not cite this exhibit at any point in its Patent Owner
`
`Response or in any of the expert declarations (i.e., Exs. 2034-2037).
`
`2024
`
`2025
`
`
`
`FRE 802: This exhibit contains hearsay. Because this exhibit is not
`
`cited in the Patent Owner Response, it is unclear how this exhibit is
`
`intended to be used. As such, Petitioner’s object to any use of this
`
`
`
`16
`
`
`
`2026
`
`exhibit as hearsay.
`
`FRE 802: This exhibit is being used as inadmissible hearsay for the
`
`contention that boric acid is toxic. (See Response, at 13-14.)
`
`
`
`FRE 901: This exhibit lacks proper authentication. Patent Owner has
`
`not produced evidence establishing from where or how this document
`
`was retrieved.
`
`FRE 401/402: This exhibit is inadmissible as lacking relevance. The
`
`Patent Owner does not cite this exhibit at any point in its Patent Owner
`
`Response.
`
`
`
`FRE 802: This exhibit contains hearsay. Because this exhibit is not
`
`cited in the Patent Owner Response, it is unclear how this exhibit is
`
`2027
`
`intended to be used. As such, Petitioner’s object to any use of this
`
`exhibit as hearsay.
`
`
`
`FRE 703: This exhibit is cited only in an expert declaration. The
`
`expert declarations, however, do not establish that this exhibit includes
`
`the type of facts or data that would normally be reasonably relied on
`
`by experts in the particular field. Thus, this exhibit and any paragraph
`
`
`
`17
`
`
`
`in the expert declarations citing to this exhibit are inadmissible under
`
`FRE 703. Further, Patent Owners have also failed to establish that this
`
`exhibit’s probative value substantially outweighs any prejudicial
`
`effect. Indeed, the omission of any citation to this exhibit in the Patent
`
`Owner’s Response suggests that Patent Owner believes that this
`
`exhibit has little if any probative value. As such, this exhibit is
`
`inadmissible as evidence to be presented to the Board under FRE 703.
`
`Petitioner’s object to the following excerpts of the deposition
`
`testimony cited in the Patent Owner’s response for the reasons
`
`indicated below and made on the record during the deposition. The
`
`2032
`
`testimony cited from 246:11-253:13 was objected to as asked and
`
`answered at 249:17-18 and was objected to for form at 251:3 and
`
`251:12. Testimony cited from 124:7-18 was objected to for form at
`
`124:10.
`
`Petitioner’s object to the following excerpts of the deposition
`
`testimony cited in the Patent Owner’s response for the reasons
`
`2033
`
`indicated below and made on the record during the deposition. The
`
`testimony cited from 39:4-48:5 was objected to under Rule 26 at
`
`43:15-23 and 44:7-11, and was also objected to for form and under
`
`Rule 26 at 46:25-47:1.
`
`
`
`18
`
`
`
`FRE 401/402: The following paragraphs from this declaration are not
`
`cited in the Patent Owner Response and there are inadmissible as
`
`lacking relevance: 14-17; 104-106; 110-113; 116-117; 127-129; 131-
`
`132; 134; 136; 138-141; 144-147; 152-154; 156-157; 164; 166-171;
`
`2034
`
`176-185; 188; 202-204; 209-210.2
`
`
`
`FRE 703: Petitioner’s object to each paragraph citing to an exhibit
`
`that is objected to herein under FRE 703 as such paragraphs lack a
`
`sufficient foundation.
`
`FRE 401/402: The following paragraphs from this declaration are not
`
`cited in the Patent Owner Response and there are inadmissible as
`
`2035
`
`lacking relevance: 14-20; 23; 25; 28; 30; 32; 34; 36; 41; 56-57; 61-62;
`
`65-83; 85; 92-103; 115-116; 121; 126; 132-135; 140-141.
`
`
`
`
`2 Petitioner notes that paragraphs 18-102 are cited in Footnote No. 3 on Page 10 of
`
`the Patent Owner Response. However, under the reasoning presented by the
`
`PTAB in Cisco Sys., Inc. v. C-Cation Techs., LLC, Case IPR2014-00454 (PTAB,
`
`Aug. 29, 2014), arguments presented only in footnote citing large portions of
`
`another document should not to be considered.
`
`
`
`19
`
`
`
`FRE 703: Petitioner’s object to each paragraph citing to an exhibit
`
`that is objected to herein under FRE 703 as such paragraphs lack a
`
`sufficient foundation.
`
`FRE 401/402: The following paragraphs from this declaration are not
`
`cited in the Patent Owner Response and there are inadmissible as
`
`lacking relevance: 8-16; 18-20; 32-45; 48-50; 53-59.
`
`2036
`
`
`
`FRE 703: Petitioner’s object to each paragraph citing to an exhibit
`
`that is objected to herein under FRE 703 as such paragraphs lack a
`
`sufficient foundation.
`
`FRE 401/402: The following paragraphs from this declaration are not
`
`cited in the Patent Owner Response and there are inadmissible as
`
`lacking relevance: 23-25; 27-33; 89. Further, this declaration relates
`
`to objective indicia of non-obviousness. Patent Owner has failed to
`
`establish in its Patent Owner Response that its commercial product is
`
`covered by a specific claim or claims of the patent. Accordingly,
`
`2037
`
`absent such a showing and nexus between the alleged objective indicia
`
`and the claimed invention, any purported evidence supporting the
`
`Patent Owner’s objective indicia arguments is irrelevant.
`
`
`
`
`
`20
`
`
`
`FRE 403: Because Patent Owner has failed to establish a nexus
`
`between the claims of the patent and the alleged objective indicia
`
`asserted in the Patent Owner Response, any introduction of this exhibit
`
`for purposes of supporting an objective indicia argument would be
`
`unfairly prejudicial and would lack any probative value.
`
`
`
`FRE 703: Petitioner’s object to each paragraph citing to an exhibit
`
`that is objected to herein under FRE 703 as such paragraphs lack a
`
`sufficient foundation.
`
`FRE 401/402: This exhibit is inadmissible as lacking relevance. The
`
`Patent Owner does not cite this exhibit at any point in its Patent Owner
`
`Response.
`
`
`
`FRE 802: This exhibit contains hearsay. Because this exhibit is not
`
`2038
`
`cited in the Patent Owner Response, it is unclear how this exhibit is
`
`intended to be used. As such, Petitioner’s object to any use of this
`
`exhibit as hearsay.
`
`
`
`FRE 703: This exhibit is cited only in an expert declaration. The
`
`expert declarations, however, do not establish that this exhibit includes
`
`
`
`21
`
`
`
`the type of facts or data that would normally be reasonably relied on
`
`by experts in the particular field. Thus, this exhibit and any paragraph
`
`in the expert declarations citing to this exhibit are inadmissible under
`
`FRE 703. Further, Patent Owners have also failed to establish that this
`
`exhibit’s probative value substantially outweighs any prejudicial
`
`effect. Indeed, the omission of any citation to this exhibit in the Patent
`
`Owner’s Response suggests that Patent Owner believes that this
`
`exhibit has little if any probative value. As such, this exhibit is
`
`inadmissible as evidence to be presented to the Board under FRE 703.
`
`FRE 401/402: This exhibit is inadmissible as lacking relevance. The
`
`Patent Owner does not cite this exhibit at any point in its Patent Owner
`
`Response.
`
`
`
`FRE 802: This exhibit contains hearsay. Because this exhibit is not
`
`2039
`
`cited in the Patent Owner Response, it is unclear how this exhibit is
`
`intended to be used. As such, Petitioner’s object to any use of this
`
`exhibit as hearsay.
`
`
`
`FRE 703: This exhibit is cited only in an expert declaration. The
`
`expert declarations, however, do not establish that this exhibit includes
`
`
`
`22
`
`
`
`the type of facts or data that would normally be reasonably relied on
`
`by experts in the particular field. Thus, this exhibit and any paragraph
`
`in the expert declarations citing to this exhibit are inadmissible under
`
`FRE 703. Further, Patent Owners have also failed to establish that this
`
`exhibit’s probative value substantially outweighs any prejudicial
`
`effect. Indeed, the omission of any citation to this exhibit in the Patent
`
`Owner’s Response suggests that Patent Owner believes that this
`
`exhibit has little if any probative value. As such, this exhibit is
`
`inadmissible as evidence to be presented to the Board under FRE 703.
`
`FRE 401/402: This is exhibit is inadmissible as lacking relevance.
`
`Patent Owner asserts that there was a long felt need for “a safe and
`
`effective topical onychomycosis treatment,” yet Patent Owner has
`
`failed to establish in its Patent Owner Response that its commercial
`
`product is covered by a specific claim of the patent and solves that
`
`2040
`
`alleged long-felt need. (See Response, at 61.) Accordingly, absent
`
`such a nexus, any purported evidence supporting the Patent Owner’s
`
`long-felt need arguments is irrelevant. This exhibit is also not prior art
`
`as it is from 2014, further suggesting its irrelevance.
`
`
`
`FRE 403: Because Patent Owner has failed to establish a nexus
`
`
`
`23
`
`
`
`between the claims of the patent and the alleged objective indicia
`
`asserted in the Patent Owner response, any introduction of this exhibit
`
`for purposes of supporting an objective indicia argument would be
`
`unfairly prejudicial and would lack any probative value.
`
`
`
`FRE 703: This exhibit is cited in an expert declaration. The expert
`
`declarations, however, do not establish that this exhibit includes the
`
`type of facts or data that would normally be reasonably relied on by
`
`experts in the particular field. Thus, this exhibit and any paragraph in
`
`the expert declarations citing to this exhibit are inadmissible under
`
`FRE 703. Further, Patent Owners have also failed to establish that this
`
`exhibit’s probative value substantially outweighs any prejudicial
`
`effect. As such, this exhibit is inadmissible as evidence to be
`
`presented to the Board under FRE 703.
`
`
`
`FRE 802: This exhibit is being used as inadmissible hearsay for the
`
`contention that human nail is known to considerably hinder the
`
`penetration of topically applied drugs, that dermatophytes are major
`
`etiologic agents of onychomycosis, that a POSA would not have sought
`
`
`
`24
`
`
`
`to develop a pharmaceutical formulation for treating dermatophyte
`
`infections by starting with a reference that has no teaching concerning
`
`dermatophytes, and that a need existed for a safe and effective topical
`
`treatment for as long as there has been onychomycosis. (See Response,
`
`at 18, 36, 44, 61.)
`
`FRE 401/402: This is exhibit is inadmissible as lacking relevance.
`
`Patent Owner asserts that there was a long felt need for “a safe and
`
`effective topical onychomycosis treatment,” yet Patent Owner has
`
`failed to establish in its Patent Owner Response that its commercial
`
`product is covered by a specific claim of the patent and solves that
`
`alleged long-felt need. (See Response, at 61.) Accordingly, absent
`
`such a nexus, any purported evidence supporting the Patent Owner’s
`
`2041
`
`long-felt need arguments is irrelevant. This exhibit is also not prior art
`
`as it is from 2014, further suggesting its irrelevance.
`
`
`
`FRE 403: Because Patent Owner has failed to establish a nexus
`
`between the claims of the patent and the alleged objective indicia
`
`asserted in the Patent Owner response, any introduction of this exhibit
`
`for purposes of supporting an objective indicia argument would be
`
`unfairly prejudicial and would lack any probative value.
`
`
`
`25
`
`
`
`
`
`FRE 703: This exhibit is cited in an expert declaration. The expert
`
`declarations, however, do not establish that this exhibit includes the
`
`type of facts or data that would normally be reasonably relied on by
`
`experts in the particular field. Thus, this exhibit and any paragraph in
`
`the expert declarations citing to this exhibit are inadmissible under
`
`FRE 703. Further, Patent Owners have also failed to establish that this
`
`exhibit’s probative value substantially outweighs any prejudicial
`
`effect. As such, this exhibit is inadmissible as evidence to be
`
`presented to the Board under FRE 703.
`
`
`
`FRE 802: This exhibit is being used as inadmissible hearsay for the
`
`contention that topical therapy so far has been partially successful
`
`owing to the poor penetration of the drug to the nail bed, which is the
`
`residing site of most of the pathogens in the diseased conditions and
`
`that topical therapy avoids the problems associated with the adverse
`
`events and drug interactions of systemic drugs and may have greater
`
`patient compliance. (See Response, at 18, 62.)
`
`FRE 401/402: This exhibit is inadmissible as irrelevant. This exhibit
`
`is also not prior art as it is was created after the priority date of the
`
`26
`
`2042
`
`
`
`
`
`patent.
`
`
`
`FRE 703: This exhibit is cited in an expert declaration. The expert
`
`declarations, however, do not establish that this exhibit includes the
`
`type of facts or data that would normally be reasonably relied on by
`
`experts in the particular field. Thus, this exhibit and any paragraph in
`
`the expert declarations citing to this exhibit are inadmissible under
`
`FRE 703. Further, Patent Owners have also failed to establish that this
`
`exhibit’s probative value substantially outweighs any prejudicial
`
`effect. As such, this exhibit is inadmissible as evidence to be
`
`presented to the Board under FRE 703.
`
`
`
`FRE 802: This exhibit is being used as inadmissible hearsay for the
`
`contention that changing a boron-containing closo-tetraphenyl
`
`porphyrin to a boron-containing nido-tetra porphyrin resulted in a
`
`compound that was severely hepatoxic, that boronated compounds
`
`cannot be successfully administered because of overt toxicity, and that
`
`minor structural changes in boron-containing compounds can result in
`
`profound differences in toxicity. (See Response, at 13, 15, 42.)
`
`2043
`
`FRE 703: This exhibit is cited in an expert declaration. The expert
`
`
`
`27
`
`
`
`declarations, however, do not establish that this exhibit includes the
`
`type of facts or data that would normally be reasonably relied on by
`
`experts in the particular field. Thus, this exhibit and any paragraph in
`
`the expert declarations citing to this exhibit are inadmissible under
`
`FRE 703. Further, Patent Owners have also failed to establish that this
`
`exhibit’s probative value substantially outweighs any prejudicial
`
`effect. As such, this exhibit is inadmissible as evidence to be
`
`presented to the Board under FRE 703.
`
`
`
`FRE 802: This exhibit is being used as inadmissible hearsay for the
`
`contention that external application of boron-containing compounds
`
`should be discouraged because of toxicity. (See Response, at 13.)
`
`FRE 703: This exhibit is cited in an expert declaration. The expert
`
`declarations, however, do not establish that this exhibit includes the
`
`type of facts or data that wou
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
