`
`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`_____________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________________
`
`J. KYLE BASS and ERICH SPANGENBERG,
`
`Petitioners
`
`v.
`
`FRESENIUS KABI USA, LLC,
`
`Patent Owner
`
`Patent 8,476,010
`
`_____________________
`
`Inter Partes Review No.: IPR2016-00254
`
`
`
`Petitioners’ Responses To Patent Owner’s Observations On Cross
`Examination
`
`
`
`
`
`Petitioners’ Responses To Patent Owner’s Observations On Cross Examination
`Petition for Inter Partes Review 2016-00254
`
`
`In response to Patent Owner’s Observations On Cross Examination,
`
`Petitioners hereby respond, on an observation-by-observation basis, as follows:
`
`Observation 1: Dr. Feinberg’s testimony does not support Patent Owner’s
`Conclusions or contradict his opinions as set forth in his declarations.
`
`
`
`Patent Owner alleges that Dr. Feinberg’s testimony is relevant to show that
`
`terminal sterilization is the only appropriate method of sterilizing the claimed
`
`formulations. But this testimony is not relevant to the claimed invention because the
`
`claims of U.S. Patent 8,476,010 (“the ‘010 patent”) do not recite any particular
`
`sterilization method (Exhibit 1001, ‘010 patent, col. 27, l. 54 – col. 33, l. 13). Indeed,
`
`the ‘010 patent indicates that the invention is not limited to a particular sterilization
`
`technique: “[t]he present invention's composition is a sterile aqueous formulation
`
`and is prepared by standard manufacturing techniques using, for example, aseptic
`
`manufacture, sterile filtration or terminal sterilization by autoclaving” (id. at col. 7,
`
`ll. 31-34). The testimony cited by Patent Owner refers to a sterilization method used
`
`in the manufacture of commercial propofol (Diprivan), not to the claims of the ‘010
`
`patent.
`
`Patent Owner also alleged that Dr. Feinberg’s testimony contradicts Dr.
`
`Feinberg’s opinion that “Mannermaa, the ‘919 patent, and Lehr would have
`
`discouraged a POSA from using autoclave, they would not have discouraged a
`
`POSA from the claimed invention using other sterilization techniques.” But the
`
`testimony cited by Patent Owner was not about Mannermaa, the ‘919 patent, or Lehr.
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`Petition for Inter Partes Review 2016-00254
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`Rather, the testimony related to a document about the manufacture of Diprivan.
`
`Accordingly, none of the testimony contradicts Dr. Feinberg’s explanation that “a
`
`POSA at the time of the invention of the ‘010 patent would have understood that the
`
`number of particulates shed from a stopper after autoclaving would have been
`
`significantly higher than the number of particulates shed from the stopper after
`
`treatment other sterilization techniques like aseptic manufacture” (Ex. 1044, Dr.
`
`Feinberg, Supplemental Decl., ¶ 23). “That is, the siliconized bromobutyl stopper
`
`with a different sterilization technique would have shed significantly fewer
`
`particulates than those reported in Mannermaa, and the ‘919 patent for the autoclave
`
`sterilization technique” (id.).
`
`Observation 2: Dr. Feinberg’s testimony does not contradict his opinions as set
`forth in his declarations.
`
`
`
`Patent Owner alleges that Dr. Feinberg’s testimony is relevant because it
`
`contradicts Petitioners’ argument that a POSA would consider sterile filtration as an
`
`alternative to terminal sterilization by autoclave. But this testimony is not relevant
`
`to the claimed invention because the claims of the ‘010 patent do not recite any
`
`particular sterilization method (Exhibit 1001, ‘010 patent, col. 27, l. 54 – col. 33, l.
`
`13). Indeed, the ‘010 patent indicates that the invention is not limited to a particular
`
`sterilization technique: “[t]he present invention's composition is a sterile aqueous
`
`formulation and is prepared by standard manufacturing techniques using, for
`
`2
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`Petitioners’ Responses To Patent Owner’s Observations On Cross Examination
`Petition for Inter Partes Review 2016-00254
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`example, aseptic manufacture, sterile filtration or terminal sterilization by
`
`autoclaving” (id. at col. 7, ll. 31-34). The testimony cited by Patent Owner refers to
`
`a sterilization method used in the manufacture of commercial propofol (Diprivan),
`
`not to the claims or any other part of the ‘010 patent.
`
`Observation 3: Dr. Feinberg’s testimony does not contradict his opinions as set
`forth in his declarations.
`
`Patent Owner alleges that Dr. Feinberg’s testimony is relevant because it
`
`contradicts Petitioners’ argument that a POSA would have been motivated to use
`
`aseptic manufacture or sterile filtration instead of consider sterile filtration as an
`
`alternative to terminal sterilization by autoclave. But this testimony is not relevant
`
`to the claimed invention because the claims of the ‘010 patent do not recite any
`
`particular sterilization method (Exhibit 1001, ‘010 patent, col. 27, l. 54 – col. 33, l.
`
`13). Indeed, the ‘010 patent indicates that the invention is not limited to a particular
`
`sterilization technique: “[t]he present invention's composition is a sterile aqueous
`
`formulation and is prepared by standard manufacturing techniques using, for
`
`example, aseptic manufacture, sterile filtration or terminal sterilization by
`
`autoclaving” (id. at col. 7, ll. 31-34). The testimony cited by Patent Owner consists
`
`merely of responses to questions about whether Patent Owner’s counsel read certain
`
`sentences from Exhibit 2061 correctly.
`
`Patent Owner also alleged that Dr. Feinberg’s testimony contradicts Dr.
`
`Feinberg’s opinion that “Mannermaa, the ‘919 patent, and Lehr would have
`
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`Petitioners’ Responses To Patent Owner’s Observations On Cross Examination
`Petition for Inter Partes Review 2016-00254
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`discouraged a POSA from using autoclave, they would not have discouraged a
`
`POSA from the claimed invention using other sterilization techniques.” But the
`
`testimony cited by Patent Owner was not about Mannermaa, the ‘919 patent, or Lehr.
`
`Rather, the testimony related to a different document (European Regulatory
`
`Guidance, Exhibit 2061). Accordingly, none of the testimony contradicts Dr.
`
`Feinberg’s explanation that “a POSA at the time of the invention of the ‘010 patent
`
`would have understood that the number of particulates shed from a stopper after
`
`autoclaving would have been significantly higher than the number of particulates
`
`shed from the stopper after treatment other sterilization techniques like aseptic
`
`manufacture” (Ex. 1044, Dr. Feinberg, Supplemental Decl., ¶ 23). “That is, the
`
`siliconized bromobutyl stopper with a different sterilization technique would have
`
`shed significantly fewer particulates than those reported in Mannermaa, and the ‘919
`
`patent for the autoclave sterilization technique” (id.).
`
`Observation 4: Dr. Feinberg’s testimony does not support Patent Owner’s
`conclusions and does not contradict his opinions.
`
`Patent Owner alleges that Dr. Feinberg’s testimony is relevant because it
`
`allegedly shows that the prior art taught that drug product containers should be
`
`selected to allow terminal sterilization since it is the preferred sterilization method.
`
`But this testimony is not relevant to the claimed invention because the claims of the
`
`‘010 patent do not recite any particular sterilization method (Exhibit 1001, ‘010
`
`patent, col. 27, l. 54 – col. 33, l. 13). Indeed, the ‘010 patent indicates that the
`
`4
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`Petitioners’ Responses To Patent Owner’s Observations On Cross Examination
`Petition for Inter Partes Review 2016-00254
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`invention is not limited to a particular sterilization technique: “[t]he present
`
`invention's composition is a sterile aqueous formulation and is prepared by standard
`
`manufacturing techniques using, for example, aseptic manufacture, sterile filtration
`
`or terminal sterilization by autoclaving” (id. at col. 7, ll. 31-34). The testimony cited
`
`by Patent Owner consists merely of responses to questions about whether Patent
`
`Owner’s counsel read certain sentences from Exhibit 2059 correctly.
`
`Patent Owner also alleged that this testimony contradicts Dr. Feinberg’s
`
`opinion that a POSA would consider using aseptic manufacture or sterile filtration
`
`with the claimed invention. But Dr. Feinberg’s testimony does not, in fact,
`
`contradict his opinions because the ‘010 patent itself indicates that its alleged
`
`invention could use other sterilization techniques such as aseptic manufacture and
`
`sterile filtration. Indeed, the autoclave particulate data in other references of record
`
`in this proceeding such as Mannermaa and the ‘919 patent would have discouraged
`
`a POSA from using autoclave and would have encouraged use of a different
`
`sterilization method that resulted in significantly fewer particulates.
`
`Observation 5: Dr. Feinberg’s testimony does not support Patent Owner’s
`conclusions and does not contradict his opinions.
`
`Patent Owner repeats its allegation that Dr. Feinberg’s testimony is relevant
`
`and contradicts his opinions because it shows that terminal sterilization since it is
`
`the preferred sterilization method. But this testimony is not relevant and does not
`
`contradict any of Dr. Feinberg’s opinion because as explained above, (i) the claims
`
`5
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`Petitioners’ Responses To Patent Owner’s Observations On Cross Examination
`Petition for Inter Partes Review 2016-00254
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`of the ‘010 patent are not limited to a particular sterilization method, (ii) the
`
`Specification indicates that many different sterilization methods could be used with
`
`the claimed invention, and (iii) different references would have encouraged the use
`
`of different sterilization methods. The testimony cited by Patent Owner consists
`
`merely of responses to questions about whether Patent Owner’s counsel read certain
`
`sentences from Exhibit 2060 correctly.
`
`Observation 6: Dr. Feinberg’s testimony does not support Patent Owner’s
`conclusions and does not contradict his opinions.
`
`Patent Owner similarly alleges that Dr. Feinberg’s testimony is relevant and
`
`contradicts his opinions because it allegedly shows that terminal sterilization is a
`
`requirement for a closure for an injectable product. But this testimony is not relevant
`
`and does not contradict any of Dr. Feinberg’s opinion because (i) none of the claims
`
`challenged in this IPR proceeding are limited to an injectable product (ii) the claims
`
`of the ‘010 patent are not limited to a particular sterilization method, (iii) the
`
`Specification indicates that many different sterilization methods could be used with
`
`the claimed invention, and (iv) different references would have encouraged the use
`
`of different sterilization methods, as explained above. The testimony cited by Patent
`
`Owner consists merely of responses to questions about whether Patent Owner’s
`
`counsel read certain sentences from Exhibit 1047 correctly.
`
`6
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`Petitioners’ Responses To Patent Owner’s Observations On Cross Examination
`Petition for Inter Partes Review 2016-00254
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`Observation 7: Dr. Feinberg’s testimony does not support Patent Owner’s
`conclusions.
`
`Patent Owner similarly alleges that Dr. Feinberg’s testified that commercial
`
`efficiency is the principal motivation for Petitioner’s proposed combination of prior
`
`art. But Dr. Feinberg’s testimony quoted by Patent Owner does not indicate that
`
`commercial efficiency is the principal motivation. His testimony instead indicates
`
`that commercial efficiency is only one of many sources of motivation: “[t]he
`
`advantages are more operational that you're looking for” (Ex. 2064, 231:23-35); “the
`
`motivation for a POSA to use a siliconized stopper is predominantly one of
`
`manufacturing efficiency” (Ex. 2064, 232:11-13).
`
`Observation 8: Dr. Feinberg’s testimony does not support Patent Owner’s
`conclusions and does not contradict his opinions.
`
`Patent Owner similarly alleges that Dr. Feinberg’s testimony is relevant
`
`because it indicates that commercial efficiency is not a sufficient basis to change the
`
`sterilization method from terminal sterilization. But this testimony is not relevant
`
`and does not contradict any of Dr. Feinberg’s opinion because (i) none of the claims
`
`challenged in this IPR proceeding are limited to a particular sterilization method, (ii)
`
`the Specification indicates that many different sterilization methods could be used
`
`with the claimed invention, and (iii) different references would have encouraged the
`
`use of different sterilization methods, as explained above. The testimony cited by
`
`Patent Owner consists merely of responses to questions about whether Patent
`
`7
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`Petitioners’ Responses To Patent Owner’s Observations On Cross Examination
`Petition for Inter Partes Review 2016-00254
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`Owner’s counsel read certain sentences from Exhibit 2061 (European Regulatory
`
`Guidance) correctly. Dr. Feinberg also testified that “It's [Europe is] a different
`
`market than in the U.S.” (Exhibit 2064 (308:23-24).
`
`Observation 9: Dr. Feinberg’s testimony does not support Patent Owner’s
`conclusions and does not contradict his opinions.
`
`Patent Owner concluded that Dr. Feinberg admitted he did not have an opinion
`
`regarding whether a POSA following European regulatory guidelines would adopt
`
`different filtering techniques. But Patent Owner’s characterization of Dr. Feinberg’s
`
`testimony is incorrect because Dr. Feinberg explained that he could not answer
`
`questions about a document that was set before him for the very first time at the
`
`deposition until he had a chance to read it (Exhibit 2064, 309:18-21). Moreover, this
`
`testimony is not relevant and does not contradict any of Dr. Feinberg’s opinions
`
`because (i) none of the claims challenged in this IPR proceeding are limited to a
`
`particular sterilization method, (ii) the Specification indicates that many different
`
`sterilization methods could be used with the claimed invention, and (iii) different
`
`references would have encouraged the use of different sterilization methods, as
`
`explained above.
`
`Observation 10: Dr. Feinberg’s testimony does not support Patent Owner’s
`conclusions and does not contradict his opinions.
`
`Patent Owner concluded that Dr. Feinberg admitted that it was generally less
`
`expensive to manufacture drugs using terminal sterilization instead than aseptic
`
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`Petitioners’ Responses To Patent Owner’s Observations On Cross Examination
`Petition for Inter Partes Review 2016-00254
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`manufacturing techniques and that he “contradicts Petitioners’ argument that
`
`economic considerations would motivate a POSA to use the proposed combination
`
`with the more expensive sterilization methods suggested by Petitioners. But Patent
`
`Owner’s characterization of Dr. Feinberg’s testimony and Petitioners’ argument are
`
`incorrect. Patent Owner quoted only a portion of Dr. Feinberg’s answer to a
`
`question. The omitted portion states that “I'm sure there are plenty of exceptions
`
`that would come into play, though, that might say that's probably not -- that may not
`
`be true” (Ex. 2064, 345:2-5). In addition and contrary to Patent Owner’s
`
`characterization, Petitioners had argued that many factors would have motivated a
`
`POSA to modify the prior art to replace un-siliconized stoppers with siliconized
`
`stoppers such as lubricity, resistance to moisture transfer, ease of manufacture, more
`
`easily inserted into and removed from containers, manufactured more efficiently,
`
`etc. (see e.g., Petition, pp. 1-2, 12-18, and 26-27).
`
`Moreover, this testimony is not relevant and does not contradict any of Dr.
`
`Feinberg’s opinions because (i) none of the claims challenged in this IPR proceeding
`
`are limited to a particular sterilization method, (ii) the Specification indicates that
`
`many different sterilization methods could be used with the claimed invention, and
`
`(iii) different references would have encouraged the use of different sterilization
`
`methods, as explained above.
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`9
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`Petitioners’ Responses To Patent Owner’s Observations On Cross Examination
`Petition for Inter Partes Review 2016-00254
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`Observation 11: Dr. Feinberg’s testimony does not support Patent Owner’s
`conclusions.
`
`Patent Owner concluded that Dr. Feinberg statement concerning the relative
`
`costs of different sterilization methods was relevant because it indicates that
`
`Petitioners did not compare the economic benefits of silicone oil treated stoppers to
`
`sterilization methods. But this testimony is not relevant because (i) none of the
`
`claims challenged in this IPR proceeding are limited to a particular sterilization
`
`method, (ii) the Specification indicates that many different sterilization methods
`
`could be used with the claimed invention, and (iii) different references would have
`
`encouraged the use of different sterilization methods, as explained above. Moreover,
`
`both Petitioners and their expert did explain the reasons why a POSA would have
`
`been motivated to use siliconized stoppers. (see e.g., Petition, pp. 1-2, 12-18, and
`
`26-27).
`
`Observation 12: Dr. Feinberg’s testimony does not support Patent Owner’s
`conclusions.
`
`Patent Owner alleged that Dr. Feinberg’s testimony of the process of aseptic
`
`manufacture “is relevant because it illustrates the significant additional expense
`
`associated with aseptic manufacturing.” But the portions of the transcript quoted by
`
`Patent Owner do not discuss the expenses associated with aseptic manufacturing and
`
`do not compare these expenses with those of other types of sterilization. In addition,
`
`the quoted portions of the transcript were stated by Patent Owner’s attorney, not Dr.
`
`10
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`Petition for Inter Partes Review 2016-00254
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`Feinberg. Moreover, Patent Owner omitted Dr. Feinberg’s discussion of an aseptic
`
`manufacturing process as “a way to limit the aseptic condition, you know, geometry
`
`or room size requirement such that, you know, that filtration step -- you just need to
`
`have enough space to do that filtration step into a receptacle, and in order to put the
`
`cap on top of that receptacle, that process needs to be done aseptically as opposed to
`
`you could move upstream in the process where, as you said, everything prior to that
`
`could have been sterile. You don't need that much room in order to manufacture it.”
`
`(Ex. 2064, 281:23-282:10).
`
`Moreover, this testimony is not relevant because (i) none of the claims
`
`challenged in this IPR proceeding are limited to a particular sterilization method, (ii)
`
`the Specification indicates that many different sterilization methods could be used
`
`with the claimed invention, and (iii) different references would have encouraged the
`
`use of different sterilization methods, as explained above.
`
`Observation 13: Dr. Feinberg’s testimony does not support Patent Owner’s
`conclusions.
`
`Patent Owner alleged that Dr. Feinberg’s further testimony about the process
`
`of aseptic manufacture “is relevant because it illustrates the significant additional
`
`expense associated with aseptic manufacturing.” But the portions of the transcript
`
`quoted by Patent Owner do not discuss the expenses associated with aseptic
`
`manufacturing and do not compare these expenses with those of other types of
`
`sterilization. In addition, the quoted portions of the transcript were stated by Patent
`
`11
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`Petitioners’ Responses To Patent Owner’s Observations On Cross Examination
`Petition for Inter Partes Review 2016-00254
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`Owner’s attorney, not Dr. Feinberg. Moreover, Patent Owner omitted Dr.
`
`Feinberg’s discussion of an aseptic manufacturing process as explained above. (Ex.
`
`2064, 281:23-282:10).
`
`Moreover, this testimony is not relevant because (i) none of the claims
`
`challenged in this IPR proceeding are limited to a particular sterilization method, (ii)
`
`the Specification indicates that many different sterilization methods could be used
`
`with the claimed invention, and (iii) different references would have encouraged the
`
`use of different sterilization methods, as explained above.
`
`Observation 14: Dr. Feinberg’s testimony does not support Patent Owner’s
`conclusions.
`
`Patent Owner asserted that Dr. Feinberg’s additional testimony of the process
`
`of aseptic manufacture “is relevant because it illustrates the significant additional
`
`expense associated with aseptic manufacturing.” But the portions of the transcript
`
`quoted by Patent Owner do not discuss the expenses associated with aseptic
`
`manufacturing and do not compare these expenses with those of other types of
`
`sterilization. In addition, the quoted portions of the transcript were stated by Patent
`
`Owner’s attorney, not Dr. Feinberg. Moreover, Patent Owner omitted Dr.
`
`Feinberg’s discussion of an aseptic manufacturing process as explained above. (Ex.
`
`2064, 281:23-282:10).
`
`Moreover, this testimony is not relevant because (i) none of the claims
`
`challenged in this IPR proceeding are limited to a particular sterilization method, (ii)
`
`12
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`Petitioners’ Responses To Patent Owner’s Observations On Cross Examination
`Petition for Inter Partes Review 2016-00254
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`the Specification indicates that many different sterilization methods could be used
`
`with the claimed invention, and (iii) different references would have encouraged the
`
`use of different sterilization methods, as explained above.
`
`Observation 15: Dr. Feinberg’s testimony does not support Patent Owner’s
`conclusions.
`
`Patent Owner asserted that Dr. Feinberg’s additional testimony regarding the
`
`movement of materials in the process of aseptic manufacture “is relevant because it
`
`illustrates the significant additional expense associated with aseptic manufacturing.”
`
`But the portions of the transcript quoted by Patent Owner do not discuss the expenses
`
`associated with aseptic manufacturing and do not compare these expenses with those
`
`of other types of sterilization. In addition, the quoted portions of the transcript were
`
`stated by Patent Owner’s attorney, not Dr. Feinberg. Moreover, Patent Owner
`
`omitted Dr. Feinberg’s discussion of an aseptic manufacturing process as explained
`
`above. (Ex. 2064, 281:23-282:10).
`
`Moreover, this testimony is not relevant because (i) none of the claims
`
`challenged in this IPR proceeding are limited to a particular sterilization method, (ii)
`
`the Specification indicates that many different sterilization methods could be used
`
`with the claimed invention, and (iii) different references would have encouraged the
`
`use of different sterilization methods, as explained above.
`
`13
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`Petition for Inter Partes Review 2016-00254
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`Observation 16: Dr. Feinberg’s testimony does not support Patent Owner’s
`conclusions.
`
`Patent Owner asserted that Dr. Feinberg’s additional testimony of the process
`
`of aseptic manufacture regarding media fills “is relevant because it illustrates the
`
`significant additional expense associated with aseptic manufacturing.” But the
`
`portions of the transcript quoted by Patent Owner do not discuss the expenses
`
`associated with aseptic manufacturing and do not compare these expenses with those
`
`of other types of sterilization. In addition, the quoted portions of the transcript were
`
`stated by Patent Owner’s attorney, not Dr. Feinberg. Moreover, Patent Owner
`
`omitted Dr. Feinberg’s discussion of an aseptic manufacturing process as explained
`
`above. (Ex. 2064, 281:23-282:10).
`
`Moreover, this testimony is not relevant because (i) none of the claims
`
`challenged in this IPR proceeding are limited to a particular sterilization method, (ii)
`
`the Specification indicates that many different sterilization methods could be used
`
`with the claimed invention, and (iii) different references would have encouraged the
`
`use of different sterilization methods, as explained above.
`
`Observation 17: Dr. Feinberg’s testimony does not support Patent Owner’s
`conclusions and does not contradict his opinions as set forth in his declarations.
`
`Patent Owner asserted that Dr. Feinberg’s testimony regarding Mannermaa’s
`
`data is relevant because it contradicts Dr. Feinberg’s declaration testimony that
`
`Patent Owner’s expert should have divided the number of particulates shown in the
`
`14
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`Petitioners’ Responses To Patent Owner’s Observations On Cross Examination
`Petition for Inter Partes Review 2016-00254
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`Figures of Mannermaa by 20. But Dr. Feinberg’s testimony is not relevant because
`
`Mannermaa’s data relates to a sterilization method that is not required by any of the
`
`claims of the ‘010 patent called autoclave that results in a higher number of
`
`particulates than other sterilization methods: “PO’s arguments with respect to both
`
`Mannermaa and the ‘919 patent are not commensurate with the scope of the claims
`
`because the test results in both documents were obtained after autoclave, a
`
`sterilization procedure that would have significantly increased the number of
`
`particulates shed from the tested stoppers” (Ex. 1044, ¶ 17). This testimony is not
`
`relevant because (i) none of the claims challenged in this IPR proceeding are limited
`
`to a particular sterilization method, (ii) the Specification indicates that many
`
`different sterilization methods could be used with the claimed invention, and (iii)
`
`different references would have encouraged the use of different sterilization
`
`methods, as explained above.
`
`Moreover, Mannermaa explicitly states that the particulate data in Figures 1,
`
`2, and 3 were obtained when “ten stoppers were inserted into a conical flask” (Ex.
`
`2041, p. 73) and further states that “[t]he total average particle counts/ml for ten
`
`stoppers are presented in Figure 1. The average number of particles ≥ 2 um/ml for
`
`ten stoppers are presented in Figure 2, and particles ≥ 5 um in Figure 3” (Ex. 2014,
`
`pp. 74-74). In light of this disclosure in Mannermaa, Dr. Feinberg had explained
`
`why the data in Mannermaa’s figures would need to be divided by 20: “Dr. Davis
`
`15
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`Petition for Inter Partes Review 2016-00254
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`should have divided the measured number of particulates by 20 to account for the
`
`facts that ten stoppers would shed about ten times as many particulates as one stopper
`
`and that a stopper immersed in a solution would shed less than half of the particulates
`
`as a stopper installed in a container” (Ex 1044, ¶ 16).
`
`Observation 18: Dr. Feinberg’s testimony does not support Patent Owner’s
`conclusions and does not contradict his opinions as set forth in his declarations.
`
`Patent Owner asserted that Dr. Feinberg’s testimony regarding the data in the
`
`‘504 patent and Mannermaa is relevant because it contradicts Dr. Feinberg’s
`
`declaration testimony that “a POSA would have been skeptical of the results in the
`
`‘504 patent because they differ significantly from the results of particulate
`
`measurements that are disclosed in other references.” But Dr. Feinberg’s testimony
`
`is not relevant because the data in the ‘504 patent and Mannermaa relate to a
`
`sterilization method that is not required by any of the claims of the ‘010 patent called
`
`autoclave that results in a higher number of particulates than other sterilization
`
`methods (Ex. 1044, ¶ 17). This testimony is not relevant because (i) none of the
`
`claims challenged in this IPR proceeding are limited to a particular sterilization
`
`method, (ii) the Specification indicates that many different sterilization methods
`
`could be used with the claimed invention, and (iii) different references would have
`
`encouraged the use of different sterilization methods, as explained above.
`
`Moreover, the testimony does not relate to or contradict Dr. Feinberg’s
`
`declaration testimony that the data in the ‘504 patent is inconsistent with data from
`
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`Petition for Inter Partes Review 2016-00254
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`the Han, David, and Washington report, Sudo, or the ‘794 patent or that “a POSA
`
`would think that the ‘504 patent had significant interference. Moreover, POSA
`
`would have been particularly skeptical of the results disclosed in the ‘504 patent
`
`because the patent does not provide any details about how its testing was performed
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`and does not reference any of the standard tests (see e.g., Ex. 2040, ‘504 patent, cols.
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`8-9)” (Ex. 1044, ¶ 19). The testimony cited by Patent Owner does not relate to Han,
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`David, and Washington, Sudo, or the ‘794 patent.
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`Observation 19: Dr. Feinberg’s testimony does not support Patent Owner’s
`conclusions and does not contradict his opinions as set forth in his declarations.
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`Patent Owner asserted that Dr. Feinberg’s testimony about calculating the
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`number of particles per stopper from particles per milliliter per stopper is relevant
`
`because it contradicts Dr. Feinberg’s declaration testimony that “a POSA would
`
`understood Sudo to disclose only 34 particles per stopper, below the pharmacopeial
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`limit of 3000 particles.” But Dr. Feinberg’s testimony is not relevant to the issue of
`
`the particle data disclosed in Sudo because Sudo does not disclose the number of
`
`particles per milliliter of water. Sudo instead reported finding a total of 680
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`particles of 10 micrometers in 300 milliliters of water (Ex. 2042, the Sudo ‘794
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`patent, cols. 21-22, Table 1 (defining the Peeling Quantity Number as “Quantity of
`
`fine particles, number of particles of 10 micrometers in diameter (± 3 particles)); Ex.
`
`1044, Feinberg Supplemental Decl, ¶ 14). Therefore, the testimony cited by Patent
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`17
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`Petitioners’ Responses To Patent Owner’s Observations On Cross Examination
`Petition for Inter Partes Review 2016-00254
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`Owner is not relevant to Sudo and does not contradict Feinberg’s declaration
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`testimony.
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`Observation 20: Dr. Feinberg’s testimony does not support Dr. Davis’s opinion.
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`Patent Owner alleges that Dr. Feinberg’s testimony with respect to Exhibits
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`1045 and 2062 is relevant because it supports Dr. Davis’s opinion about problems
`
`associated with siliconization of container closures. But the testimony cited by
`
`Patent Owner consists merely of responses to questions about whether Patent
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`Owner’s counsel read certain sentences from Exhibits 1045 and 2062 correctly.
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`Also, Patent Owner did not cite to either Exhibit 1045 or 2062 in its Patent Owner
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`Response.
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`Observation 21: Dr. Feinberg’s testimony does not undermine his opinion that
`the surface area of the syringe barrels of Lomax and Capes is much greater
`than the surface area of one end of the stopper claimed in the ‘010 patent.
`
`Patent Owner alleges that Dr. Feinberg’s testimony with respect to the surface
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`area of the syringe barrels of Lomax and Capes is much greater than the surface area
`
`of one end of a stopper is undermined by his testimony regarding the roughness of
`
`the surface. But there is no indication in Dr. Feinberg’s testimony or any other place
`
`in the record of this proceeding (e.g., Petitioner’s expert’s declaration, the Patent
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`Owner Response) that any minimal difference in the roughness of the surface areas
`
`of the barrel of a syringe and the end of a stopper will have any meaningful effect
`
`on the large magnitude of the difference between the surface area of the cylindrical
`
`18
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`Petitioners’ Responses To Patent Owner’s Observations On Cross Examination
`Petition for Inter Partes Review 2016-00254
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`portion (i.e., barrel) of a syringe and the surface area of one end of a stopper that was
`
`described by Dr. Feinberg (Ex. 1044, ¶ 27).
`
`Observation 22: Dr. Feinberg’s testimony does not contradict his opinion that
`there were only a small, finite, number of solutions to improve machinability.
`
`Patent Owner alleges that Dr. Feinberg’s testimony with respect to a small
`
`number of alternatives for lubricating rubber stoppers contradicts his opinion that
`
`there were only a small, finite, number of solutions to improve machinability. But
`
`the testimony cited by Patent Owner mentions only six different alternatives (i.e.,
`
`paraffin wax, polyethylene, surface chlorination, olefinic film or coating,
`
`fluorocarbon polymer, and chemical modification). Because six is a small, finite
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`number, Feinberg’s testimony does not contradict his opinion as set forth in his
`
`declaration (Ex. 1044, ¶ 28). Moreover, in an important portion of Dr. Feinberg’s
`
`testimony that was omitted by the Patent Owner, Dr. F