`
`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.
`
`1
`
`
`
`Petitioners’ Responses To Patent Owner’s Observations On Cross Examination
`Petition for Inter Partes Review 2016-00254
`
`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
`
`
`
`Petitioners’ Responses To Patent Owner’s Observations On Cross Examination
`Petition for Inter Partes Review 2016-00254
`
`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
`
`3
`
`
`
`Petitioners’ Responses To Patent Owner’s Observations On Cross Examination
`Petition for Inter Partes Review 2016-00254
`
`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
`
`
`
`Petitioners’ Responses To Patent Owner’s Observations On Cross Examination
`Petition for Inter Partes Review 2016-00254
`
`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
`
`
`
`Petitioners’ Responses To Patent Owner’s Observations On Cross Examination
`Petition for Inter Partes Review 2016-00254
`
`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
`
`
`
`Petitioners’ Responses To Patent Owner’s Observations On Cross Examination
`Petition for Inter Partes Review 2016-00254
`
`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
`
`
`
`Petitioners’ Responses To Patent Owner’s Observations On Cross Examination
`Petition for Inter Partes Review 2016-00254
`
`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
`
`8
`
`
`
`Petitioners’ Responses To Patent Owner’s Observations On Cross Examination
`Petition for Inter Partes Review 2016-00254
`
`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.
`
`9
`
`
`
`Petitioners’ Responses To Patent Owner’s Observations On Cross Examination
`Petition for Inter Partes Review 2016-00254
`
`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
`
`
`
`Petitioners’ Responses To Patent Owner’s Observations On Cross Examination
`Petition for Inter Partes Review 2016-00254
`
`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
`
`
`
`Petitioners’ Responses To Patent Owner’s Observations On Cross Examination
`Petition for Inter Partes Review 2016-00254
`
`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
`
`
`
`Petitioners’ Responses To Patent Owner’s Observations On Cross Examination
`Petition for Inter Partes Review 2016-00254
`
`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
`
`
`
`Petitioners’ Responses To Patent Owner’s Observations On Cross Examination
`Petition for Inter Partes Review 2016-00254
`
`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
`
`
`
`Petitioners’ Responses To Patent Owner’s Observations On Cross Examination
`Petition for Inter Partes Review 2016-00254
`
`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
`
`
`
`Petitioners’ Responses To Patent Owner’s Observations On Cross Examination
`Petition for Inter Partes Review 2016-00254
`
`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
`
`16
`
`
`
`Petitioners’ Responses To Patent Owner’s Observations On Cross Examination
`Petition for Inter Partes Review 2016-00254
`
`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
`
`and does not reference any of the standard tests (see e.g., Ex. 2040, ‘504 patent, cols.
`
`8-9)” (Ex. 1044, ¶ 19). The testimony cited by Patent Owner does not relate to Han,
`
`David, and Washington, Sudo, or the ‘794 patent.
`
`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.
`
`Patent Owner asserted that Dr. Feinberg’s testimony about calculating the
`
`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
`
`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
`
`particles of 10 micrometers in 300 milliliters of water (Ex. 2042, the Sudo ‘794
`
`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
`
`17
`
`
`
`Petitioners’ Responses To Patent Owner’s Observations On Cross Examination
`Petition for Inter Partes Review 2016-00254
`
`Owner is not relevant to Sudo and does not contradict Feinberg’s declaration
`
`testimony.
`
`Observation 20: Dr. Feinberg’s testimony does not support Dr. Davis’s opinion.
`
`Patent Owner alleges that Dr. Feinberg’s testimony with respect to Exhibits
`
`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
`
`Owner’s counsel read certain sentences from Exhibits 1045 and 2062 correctly.
`
`Also, Patent Owner did not cite to either Exhibit 1045 or 2062 in its Patent Owner
`
`Response.
`
`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
`
`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
`
`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
`
`
`
`Petitioners’ Responses To Patent Owner’s Observations On Cross Examination
`Petition for Inter Partes Review 2016-00254
`
`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
`
`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
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
