Case IPR2016-01096
`Patent No. 6,667,061
`Resp. POs’ Observations on Cross-Examination of Patrick DeLuca, Ph.D.
`Attorney Docket No. 9LUYE 7.1R-004
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________________________
`
`LUYE PHARMA GROUP LTD., LUYE PHARMA(USA) LTD., SHANDONG
`LUYE PHARMACEUTICAL CO., LTD., and NANJING LUYE
`PHARMACEUTICAL CO., LTD.,
`Petitioners,
`
`v.
`
`ALKERMES PHARMA IRELAND LTD and
`ALKERMES CONTROLLED THERAPEUTICS, INC.,
`Patent Owners.
`
`Patent No. 6,667,061 to Ramstack et al.
`Issue Date: December 23, 2003
`Title: PREPARATION OF INJECTABLE
`SUSPENSIONS HAVING IMPROVED INJECTABILITY
`____________________________
`Inter Partes Review No. IPR2016-01096
`__________________________________________________________________
`
`RESPONSE TO PATENT OWNERS’ OBSERVATIONS
`ON CROSS-EXAMINATION OF PATRICK DeLUCA, PH.D.
`
`
`
`
`Mail Stop: Patent Board
`Patent Trial and Appeal Board
`U.S. Patent And Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`
`
`
`Patent No. 6,667,061
`Resp. POs’ Observations on Cross-Examination of Patrick DeLuca, Ph.D.
`Attorney Docket No. 9LUYE 7.1R-004
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________________________
`
`LUYE PHARMA GROUP LTD., LUYE PHARMA(USA) LTD., SHANDONG
`LUYE PHARMACEUTICAL CO., LTD., and NANJING LUYE
`PHARMACEUTICAL CO., LTD.,
`Petitioners,
`
`v.
`
`ALKERMES PHARMA IRELAND LTD and
`ALKERMES CONTROLLED THERAPEUTICS, INC.,
`Patent Owners.
`
`Patent No. 6,667,061 to Ramstack et al.
`Issue Date: December 23, 2003
`Title: PREPARATION OF INJECTABLE
`SUSPENSIONS HAVING IMPROVED INJECTABILITY
`____________________________
`Inter Partes Review No. IPR2016-01096
`__________________________________________________________________
`
`RESPONSE TO PATENT OWNERS’ OBSERVATIONS
`ON CROSS-EXAMINATION OF PATRICK DeLUCA, PH.D.
`
`
`
`
`Mail Stop: Patent Board
`Patent Trial and Appeal Board
`U.S. Patent And Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`
`
`
`
`Case IPR2016-01096
`Patent No. 6,667,061
`Resp. POs’ Observations on Cross-Examination of Patrick DeLuca, Ph.D.
`Attorney Docket No. 9LUYE 7.1R-004
`
`I.
`
`PATENT OWNERS’ OBSERVATIONS
`ARE AN UNAUTHORIZED SUR-REPLY
`
`The Office Patent Trial Practice Guide (“Practice Guide”) explains that the
`
`purpose of observations on cross-examination is to draw the Board’s attention to
`
`relevant cross-examination testimony that “occurs after a party has filed its last
`
`substantive paper on an issue.” Chums, Inc. v. Cablz, Inc., IPR2014-01240,
`
`Paper 32, at 2 (Aug. 6, 2015); Office Patent Trial Practice Guide, 77 Fed.
`
`Reg. 48756, 48768 (Aug. 14, 2012.). The Practice Guide makes clear that “[a]n
`
`observation . . . is not an opportunity to raise new issues, re-argue issues, or pursue
`
`objections.” Office Patent Trial Practice Guide, 77 Fed. Reg. at 48768. Rather than
`
`following the Practice Guide, Alkermes instead filed Observations that raise new
`
`issues or re-argue issues. Thus, Petitioners’ request that the Board use its discretion
`
`and dismiss Alkermes’ Motion for Observations on Cross-Examination of
`
`Dr. DeLuca. Medtronic, Inc. v. NuVasive, Inc., IPR2013-00506, Paper 37, at 3-4
`
`(Oct. 15, 2014.)
`
`
`
`
`
`
`
`Case IPR2016-01096
`Patent No. 6,667,061
`Resp. POs’ Observations on Cross-Examination of Patrick DeLuca, Ph.D.
`Attorney Docket No. 9LUYE 7.1R-004
`
`II.
`
`JOHNSON AND GUSTAFSSON
`INHERENTLY TEACH THE VISCOSITY LIMITATION
`
`Response To Observation 1:
`
`The cited testimony of Dr. DeLuca is irrelevant, incomplete, and does not
`
`confirm
`
`that Petitioners
`
`should have accounted
`
`for
`
`all grades of
`
`carboxymethylcellulose (“CMC”) to prove inherency. (Mot. 1.) The testimony was
`
`given with respect to Example 7 of the Johnson vehicle. Dr. DeLuca testified that
`
`although Example 7 did not explicitly state low CMC, Johnson stated “low . . . 3
`
`percent” CMC for all of the other examples, thus, it “would be unlikely that he
`
`would use a high in one case and low in another.” (Ex.2081, at 122:8-19.)
`
`Although Dr. DeLuca testified that it was possible to use a medium grade viscosity
`
`CMC, he explained “3 percent of the medium would probably be too high or
`
`higher than necessary” (id. 119:21-24) and “a lower concentration” would be
`
`needed (id. 154:17-19). Dr. DeLuca also testified that although possible it was
`
`“unlikely” for high viscosity grade CMC to be used as an injection vehicle. (Id.
`
`123:24-124:5.) Dr. DeLuca testified that out of all of the grades of CMC shown in
`
`the Handbook (Ex.1008), the low CMC “would be more appropriate for parenteral
`
`suspensions” (Ex.2081, at 121:16-21), and that a POSA “for a parenteral
`
`suspension would have picked the low grade [CMC]” (id. 195:14-19).
`
`2
`
`
`
`Case IPR2016-01096
`Patent No. 6,667,061
`Resp. POs’ Observations on Cross-Examination of Patrick DeLuca, Ph.D.
`Attorney Docket No. 9LUYE 7.1R-004
`
`Response To Observation 2:
`
`The cited testimony of Dr. DeLuca is irrelevant, incomplete, and does not
`
`contradict Petitioner’s testing criticism and does not “establish that use of a
`
`non-pharmaceutical grade CMC does not impact viscosity.” (Mot. 1) Dr. DeLuca’s
`
`testimony only sets forth his understanding as to what Exhibit 2073 states on its
`
`face. Despite listing “all the different CMCs from Aqualon” (Ex.2081, at 132: 2-9),
`
`Dr. DeLuca’s testimony is only related to one specific CMC, “Aqualon CMC
`
`7HF” (id. 135:4-137:4). Although Dr. DeLuca testified that “viscosity of CMC
`
`doesn’t change between food grade, pharma grade, and industry grade” (id.
`
`at 136:20-23), in Exhibit 2073, Dr. DeLuca did not testify that a POSA would use
`
`non-pharmaceutical grade CMC in an injectable suspension. To the contrary,
`
`Dr. DeLuca testified that the Handbook teaches pharmaceutical grade high,
`
`medium and low CMC and that a POSA “for a parenteral suspension would have
`
`picked the low grade [CMC].” (Ex.2081, at 194:20-195:19.)
`
`Response To Observation 3:
`
`The cited testimony of Dr. DeLuca is irrelevant, incomplete, and does not
`
`“confirm” Patent Owners’ assertion that all grades of carboxymethylcellulose
`
`(“CMC”) should be accounted for to prove inherency and does not contradict
`
`Petitioners’ testing criticism. Dr. DeLuca testified that whether he used high and
`
`3
`
`
`
`Case IPR2016-01096
`Patent No. 6,667,061
`Resp. POs’ Observations on Cross-Examination of Patrick DeLuca, Ph.D.
`Attorney Docket No. 9LUYE 7.1R-004
`
`low grade CMCs in his study, “may be irrelevant . . . [b]ecause we are not talking
`
`about parenteral use.” (Ex.2081, at 130:5-10.) Similarly, with respect
`
`to
`
`Exhibit 2031, Dr. DeLuca testified that the work did not involve the injectable
`
`suspension of microspheres or microparticles (Ex.2081, at 240:11-241:25) and that
`
`matrices were “solid” and “certainly not injectable” (id. 242:2-18). Further, the
`
`Tracy Declaration did not consider anything (such as grade of CMC) other than the
`
`amount of CMC used by Kino in estimating patentability of the ’061 invention.
`
`(Ex.1018.) Dr. DeLuca utilized the Tracy Declaration in the exact same manner as
`
`the Patent Owners, i.e., to support the assertion that the Johnson vehicle has a
`
`viscosity within the range claimed in the ’061 Patent (Pet. 17-18; Ex.1002 ¶44.)
`
`Response To Observation 4:
`
`The cited testimony of Dr. DeLuca is irrelevant, incomplete, lacks
`
`foundation, and does not contradict Petitioners’ testing criticism, nor does it
`
`“establish[] that the tested CMCs were commercially available at the time of the
`
`invention.” (Mot. 2.) Dr. DeLuca’s testimony only sets forth his understanding as
`
`to what Exhibits 2074-2077 state on their face. Dr. DeLuca testified that the
`
`disclosure “may not be accurate.” (Ex.2081, at 166:21-167:3.) Exhibits 2074
`
`and 2075, titled “Dispersions for Producing Paint For Concrete Roof Tiles, Paint
`
`for Concrete Roof Tiles and Concrete Roof Tiles Coated with Such Paint” are
`
`4
`
`
`
`Case IPR2016-01096
`Patent No. 6,667,061
`Resp. POs’ Observations on Cross-Examination of Patrick DeLuca, Ph.D.
`Attorney Docket No. 9LUYE 7.1R-004
`
`directed to industrial (non-pharmaceutical) applications, and there’s no evidence
`
`that a POSA in the relevant art would look to this technology as a source of
`
`analogous material. Similarly, Exhibits 2076 and 2077 are titled “Supplementation
`
`of Cellulose Nanofibrils with Carboxycellulose With Low Degree of Substitution”
`
`and “Additivation of Cellulose Nanofibrils With Carboxy Cellulose With Low
`
`Degree of Substitution.” None of these exhibits establishes that the ultra-low and
`
`extra-low viscosity CMC used by Patent Owners in their testing was available for
`
`use in the United States for injectable pharmaceutical suspensions. Further,
`
`Dr. DeLuca testified that “the [H]andbook pretty clearly shows the different grades
`
`of the CMC” and that “the low that’s in the [H]andbook would be more
`
`appropriate for parenteral suspensions.”(Ex.2081, at 121:16-21.) Ultra low Blanose
`
`7UL® and extra low Blanose 7EL® are not low viscosity CMCs as their viscosities
`
`are lower than the viscosity range taught in the Handbook for low CMCs
`
`(Ex.1008, at 79).
`
`Response To Observation 5:
`
`The cited testimony of Dr. DeLuca is irrelevant, incomplete, and does not
`
`contradict Petitioner’s testing criticism nor “establish[] that comparable CMCs to
`
`those tested are used in pharmaceutical applications.” (Mot. 2.) Dr. DeLuca’s
`
`testimony only sets forth his understanding as to what Exhibits 2039, 2078,
`
`5
`
`
`
`Case IPR2016-01096
`Patent No. 6,667,061
`Resp. POs’ Observations on Cross-Examination of Patrick DeLuca, Ph.D.
`Attorney Docket No. 9LUYE 7.1R-004
`
`and 2079 state on their face. Exhibit 2039 is a specification sheet from the
`
`Sigma-Aldrich website dated March 1, 2017. Exhibit 2078 was filed in 2009 and is
`
`not prior art. Similarly, Exhibit 2079 was filed in 2004 and is not prior art.
`
`Therefore, Patent Owners have not established that the ultra-low and extra-low
`
`viscosity CMCs used in its testing were available for use for injectable
`
`pharmaceutical suspensions at the time of the invention.
`
`Response To Observation 6:
`
`The cited testimony of Dr. DeLuca is irrelevant, incomplete, and does not
`
`contradict Petitioners’ testing criticism and does not “establish[] that 7UL and 7EL
`
`CMCs are considered low viscosity CMCs.” (Mot. 3.) Dr. DeLuca’s testimony
`
`only sets forth his understanding as to what Exhibit 2038 states on its face. Patent
`
`Owners have not established that Ashland CMCs were available for use at the time
`
`of invention for injectable pharmaceutical suspensions. Further, Dr. DeLuca
`
`testified that “the [H]andbook pretty clearly shows the different grades of the
`
`CMC” and that “the low that’s in the [H]andbook would be more appropriate for
`
`parenteral suspensions.” (Ex.2081, at 121:16-21.) Ultra low Blanose 7UL® and
`
`extra low Blanose 7EL® are not low viscosity CMCs as their viscosities are lower
`
`than the viscosity range taught in the Handbook for low CMCs (Ex.1008, at 79.)
`
`6
`
`
`
`Case IPR2016-01096
`Patent No. 6,667,061
`Resp. POs’ Observations on Cross-Examination of Patrick DeLuca, Ph.D.
`Attorney Docket No. 9LUYE 7.1R-004
`
`Response To Observation 7:
`
`The cited testimony of Dr. DeLuca is irrelevant, incomplete, lacks
`
`foundation, and does not contradict Petitioners’ testing criticism and does not
`
`“establish[] that 7UL CMC is considered low viscosity CMC.” (Mot. 3.)
`
`Dr. DeLuca’s testimony only sets forth his understanding as to what Exhibit 2076
`
`states on its face. Patent Owners have not established that the Blanose CMCs were
`
`available for use at the time of invention for injectable pharmaceutical suspensions.
`
`Further, Dr. DeLuca testified that “the [H]andbook pretty clearly shows the
`
`different grades of the CMC” and that “the low that’s in the [H]andbook would be
`
`more appropriate for parenteral suspensions.” (Ex.2081, at 121:16-21.) Ultra low
`
`Blanose 7UL® is not a low viscosity CMC as its viscosity is lower than the
`
`viscosity range taught in the Handbook for low CMCs (Ex.1008, at 79.)
`
`Response To Observation 8:
`
`The cited testimony of Dr. DeLuca is irrelevant, incomplete, and does not
`
`“confirm[] the generic nature of Gustafsson’s disclosure” nor does it “undermine[]
`
`Petitioners’ claims that a POSA would only use a particular subcategory” of CMC.
`
`(Mot. 4.) Dr. DeLuca’s prior testimony explained that Gustafsson’s vehicle would
`
`have substantially a viscosity in the claimed range as set forth in claim 1 of the
`
`’061 Patent based on the Tracy Declaration. (Pet. 39; Ex.1002 ¶70.) The Tracy
`
`7
`
`
`
`Case IPR2016-01096
`Patent No. 6,667,061
`Resp. POs’ Observations on Cross-Examination of Patrick DeLuca, Ph.D.
`Attorney Docket No. 9LUYE 7.1R-004
`
`Declaration did not consider anything other than the amount of CMC used by Kino
`
`comparing that to the amount of CMC used in the examples disclosed in the
`
`’061 Patent. (Ex.1018.) As Petitioners and Dr. DeLuca asserted, the Gustafsson
`
`vehicle uses 3% CMC (Pet. 39; Ex.1002 ¶70) and Dr. DeLuca utilized the Tracy
`
`Declaration, in comparing the amount of CMC disclosed in the ’061 Patent and
`
`Gustafsson, in the exact same manner as the Patent Owners, i.e., to support the
`
`assertion that the Gustafsson vehicle has a viscosity within the range claimed in the
`
`’061 Patent (Pet. 39-40; Ex.1002 ¶70).
`
`Response To Observation 9:
`
`The cited testimony of Dr. DeLuca is irrelevant, incomplete, and does not
`
`“confirm[] the generic nature of Johnson’s disclosure” nor does it “undermine[]
`
`Petitioners’ claims that a POSA would only use a particular subcategory” of CMC.
`
`(Mot. 4.) Dr. DeLuca testified that the CMC in Johnson’s Example 7 is low
`
`viscosity CMC. (Ex.2081, at 76:9-12, 122:14-19.) Further, Dr. DeLuca’s prior
`
`testimony explained that Johnson’s vehicle would have substantially a viscosity in
`
`the claimed range as set forth in claim 1 of the ’061 Patent. (Pet. 25-26; Ex.1002
`
`¶¶44, 60-61.) The Tracy Declaration, in comparing the viscosities of the CMCs of
`
`the patented invention, and Kino did not consider anything other than the amount
`
`of CMC used by Kino and the amount of the CMC used in the examples disclosed
`
`8
`
`
`
`Case IPR2016-01096
`Patent No. 6,667,061
`Resp. POs’ Observations on Cross-Examination of Patrick DeLuca, Ph.D.
`Attorney Docket No. 9LUYE 7.1R-004
`
`in the ’061 Patent. (Ex.1018.) As Petitioners and Dr. DeLuca asserted, the Johnson
`
`vehicle uses 3% low viscosity CMC (Pet. 25; Ex.1002 ¶¶59, 60, 61.) Dr. DeLuca
`
`utilized the Tracy Declaration in the exact same manner as the Patent Owners, i.e.,
`
`to support the assertion that the Johnson vehicle has a viscosity within the range
`
`claimed in the ’061 Patent (Pet. 17-18; Ex.1002 ¶44.)
`
`Response To Observation 10:
`
`The cited
`
`testimony of Dr. DeLuca
`
`is mischaracterized,
`
`irrelevant,
`
`incomplete, and does not “confirm[] that order of addition of ingredients can
`
`impact viscosity” nor does it “support[] that Petitioners should have accounted for
`
`this factor in proving inherency.” (Mot. 4-5.) Dr. DeLuca testified that sodium
`
`chloride does not impact viscosity in any significant way when it is used for the
`
`isotonic concentration of a preparation. (Ex.2081, at 190:4-9.) Dr. DeLuca also
`
`testified that a POSA would dissolve CMC in the water and then add the sodium
`
`chloride (id. 191:3-192:22, 195:20-196:24) and that “Dr. Gehrke prepared his
`
`solutions using a method that would not be used by a POSA by adding the CMC
`
`after sodium chloride” (id. 191:7-10). Dr. DeLuca actually testified that he would
`
`have tested before and after to see if it affected viscosity. (Id. 196:25-197:25 (“I
`
`would have repeated this and done it afterwards”).) When asked if his concern was
`
`9
`
`
`
`Case IPR2016-01096
`Patent No. 6,667,061
`Resp. POs’ Observations on Cross-Examination of Patrick DeLuca, Ph.D.
`Attorney Docket No. 9LUYE 7.1R-004
`
`“that the order of addition of sodium chloride could impact viscosity,” he testified
`
`that “[He has] no concern with viscosity.” (Id. 197:14-25.)
`
`Response To Observation 11:
`
`The cited testimony of Dr. DeLuca is irrelevant, incomplete, and does not
`
`undermine Petitioners’ assertion that the same CMC is used in all of Johnson’s
`
`vehicles nor does it “confirm[] that the amount and type of CMC used can change
`
`based on the particular model being studied.” (Mot. 5.) Dr. DeLuca testified that
`
`the injection vehicle used in the animal model could be optimized in the human
`
`model. (Ex.2081, at 58:15-59:11.) Both Johnson’s Examples 6 and 7 are
`
`administered by subcutaneous injection into animals. (Id. 77:8-79:7) Dr. DeLuca
`
`testified that CMC in Johnson’s Example 6 is the same low viscosity CMC as
`
`Example 7. (Id. 114:5-15, 116:24-117:12, 118:22-119:10.)
`
`Response To Observation 12:
`
`The cited testimony of Dr. DeLuca is irrelevant, incomplete, and does not
`
`“confirm[] that the supplier of CMC can impact viscosity” and it does not support
`
`Patent Owners’ assertion that “Petitioners should have accounted for this for
`
`proving inherency.” (Mot. 5.) Dr. DeLuca testified that even though a CMC could
`
`be different depending on a supplier, the CMC is added for suspendability.
`
`(Ex.2081, at 154:20-155:2.) Therefore, “you want
`
`to have a sufficient
`
`10
`
`
`
`Case IPR2016-01096
`Patent No. 6,667,061
`Resp. POs’ Observations on Cross-Examination of Patrick DeLuca, Ph.D.
`Attorney Docket No. 9LUYE 7.1R-004
`
`concentration . . . you have
`
`to balance
`
`the suspendability property with
`
`the . . . viscosity.” (Id. 155:2-12.) Furthermore, the Tracy Declaration did not
`
`consider different suppliers, different viscosity ranges, order of addition of
`
`ingredients, or anything other than the amount of CMC used by Kino compared to
`
`the amount of CMC disclosed in the examples of the ’061 Patent. (Ex.1018.)
`
`Dr. DeLuca utilized the Tracy Declaration in the exact same manner as the Patent
`
`Owners, i.e., to support the assertion that the Johnson and Gustafsson vehicles,
`
`both having 3% CMC, have a viscosity within the range claimed in the
`
`’061 Patent. (Pet. 17-18, 39-40; Ex.1002 ¶¶44, 70.)
`
`Response To Observation 13:
`
`The cited testimony of Dr. DeLuca is irrelevant, incomplete, and does not
`
`“confirm[] that polysorbates can impact viscosity” and does not support Patent
`
`Owner’s assertion that “Petitioners should have accounted for this in relying on the
`
`Tracy Declaration to prove inherency.” (Mot. 6.) In the cited testimony,
`
`Dr. DeLuca agreed with the scientific statements, but was never asked, however,
`
`whether these scientific principles would impact the viscosity. Dr. DeLuca’s prior
`
`testimony explained that polysorbates would minimally impact viscosity of an
`
`injectable suspension. (See Ex.1024 ¶68 (“a POSA would know, and Patent
`
`11
`
`
`
`Case IPR2016-01096
`Patent No. 6,667,061
`Resp. POs’ Observations on Cross-Examination of Patrick DeLuca, Ph.D.
`Attorney Docket No. 9LUYE 7.1R-004
`
`Owners’ own testing confirms, that Tween 20 at a 1% concentration would have an
`
`insignificant impact in terms of overall viscosity.”); see also Ex.2059 Tables 1, 2.)
`
`Response To Observation 14:
`
`The cited
`
`testimony of Dr. DeLuca
`
`is mischaracterized,
`
`irrelevant,
`
`incomplete, and does not “confirm[] that the method of dissolution and mixing can
`
`impact viscosity” and does not support Patent Owner’s assertion that “Petitioners
`
`should have accounted for this in proving inherency.” (Mot. 6.) Dr. DeLuca’s prior
`
`testimony explained that the Johnson and Gustafsson vehicles would provide
`
`substantially the same viscosity as the ’061 Patent. The Tracy Declaration did not
`
`consider dissolution or mixing methods or anything other than the amount of CMC
`
`used by Kino compared to the amount of CMC disclosed in the examples of the
`
`’061 Patent. (Ex.1018.) Dr. DeLuca utilized the Tracy Declaration in the exact
`
`same manner as the Patent Owners, i.e., to support the assertion that the Johnson
`
`and Gustafsson vehicles, both having 3% CMC, have a viscosity within the range
`
`claimed in the ’061 Patent. (Pet. 17-18, 39-40; Ex.1002 ¶¶44, 70.)
`
`Response To Observation 15:
`
`The cited testimony of Dr. DeLuca is irrelevant, incomplete, and does not
`
`“establish[] the standard Dr. DeLuca applied in his inherency analysis.” (Mot. 7.)
`
`The testimony relied upon has nothing to do with the inherency standard that was
`
`12
`
`
`
`Case IPR2016-01096
`Patent No. 6,667,061
`Resp. POs’ Observations on Cross-Examination of Patrick DeLuca, Ph.D.
`Attorney Docket No. 9LUYE 7.1R-004
`
`applied by Dr. DeLuca in reaching his opinion that the Johnson and Gustafsson
`
`vehicles would inherently have viscosities in the claimed range. (Ex.2081,
`
`at 148:19-154:6.) Dr. DeLuca’s prior testimony explained that the Johnson and
`
`Gustafsson vehicles would have a viscosity in the same range as claimed in the
`
`’061 Patent based on his reliance on Alkermes’ admission in the Tracy
`
`Declaration. The Tracy Declaration did not consider anything other than the
`
`amount of CMC used by Kino compared to the amount of CMC disclosed in the
`
`examples of the ’061 Patent. (Ex.1018.) Dr. DeLuca utilized the Tracy Declaration
`
`in the exact same manner as the Patent Owners, i.e., to support the assertion that
`
`the Johnson and Gustafsson vehicles, both having 3% CMC, have a viscosity
`
`within the range claimed in the ’061 Patent. (Pet. 17-18, 39-40; Ex.1002 ¶¶44, 70.)
`
`III. GUSTAFSSON TEACHES THE
`MICROPARTICLE OF THE ’061 PATENT
`
`Response To Observation 16:
`
`The cited
`
`testimony of Dr. DeLuca
`
`is mischaracterized,
`
`irrelevant,
`
`incomplete, and does not contradict Petitioners’ assertions that the microparticle
`
`limitation is satisfied by any microparticle including by Gustafsson’s PLGA
`
`coating. (Mot. 7.) It also does not “establish[] that the microparticle limitation
`
`requires that the polymeric binder function as a matrix or binder of the active agent
`
`13
`
`
`
`Case IPR2016-01096
`Patent No. 6,667,061
`Resp. POs’ Observations on Cross-Examination of Patrick DeLuca, Ph.D.
`Attorney Docket No. 9LUYE 7.1R-004
`
`and the active agent be dispersed or dissolved in the polymeric binder.” (Id.)
`
`Dr. DeLuca’s testimony concerning the disclosure in the ’061 Patent is consistent
`
`in that it differentiates between “polymer” and “polymeric binder.” (Exs.2081,
`
`at 233:17-235:12; 1001, at 5:15-18, 14:10-18.) The claim requires a “microparticle
`
`comprising a polymeric binder” and “microparticle” is defined as by the
`
`’061 Patent as “particles that contain an active agent or other substance dispersed
`
`or dissolved within a polymer that serves as a matrix or binder of the particle.”
`
`(Ex.1001, at 5:15-18.) Dr. DeLuca testified that it is his opinion that the polymeric
`
`binder does not have to have any sort of function (Ex.2081, at 229:25-232:5),
`
`unlike the “polymer” described in the definition of “microparticle” in the
`
`’061 Patent. After reading the definition of a “microparticle,” which includes a
`
`polymer, Dr. DeLuca testified that the polymer, in the definition of microparticle,
`
`functions as a binder or matrix. (Ex.2081, at 234:15-235:12.)
`
`Response To Observation 17:
`
`The cited
`
`testimony of Dr. DeLuca
`
`is mischaracterized,
`
`irrelevant,
`
`incomplete, and does not contradict Petitioners’ assertion that the microparticle
`
`limitations is satisfied by Gustafsson’s PLGA coating and does not “establish[]
`
`[that] the active is not dispersed or dissolved in PLGA coating of Gustafsson’s
`
`microparticles.” (Mot. 7-8.) Petitioners’ position and Dr. DeLuca’s prior testimony
`
`14
`
`
`
`Case IPR2016-01096
`Patent No. 6,667,061
`Resp. POs’ Observations on Cross-Examination of Patrick DeLuca, Ph.D.
`Attorney Docket No. 9LUYE 7.1R-004
`
`explained that Gustafsson teaches that any active may be used in its formulation,
`
`which includes an injection vehicle that aids in suspension of microparticles,
`
`teaches PLGA is a useful polymeric binder as a coating, and that a POSA would
`
`use Ramstack’s microparticles in Gustafsson’s vehicle (Pet. 39, 45-47; Ex.1002
`
`¶¶78, 80).
`
`IV. A POSA WOULD COMBINE THE PRIOR ART
`Response To Observation 18:
`
`The cited testimony of Dr. DeLuca is irrelevant, incomplete, and does not
`
`“confirm[] there is no reason to combine” Gustafsson’s microparticles and
`
`Ramstack’s risperidone. (Mot. 8.) Dr. DeLuca testified that based on the prior art, a
`
`POSA would know how to choose a suitable viscosity to balance suspendability
`
`and injectability (Ex.2081, at 9:11-23, 15:15-16:9, 38:24-39:3, 154:23-155:12) and
`
`how to choose a suitable vehicle (id. 41:8-20). Further, Dr. DeLuca’s prior
`
`testimony explains that Gustafsson teaches that any active may be used in its
`
`formulation, which includes an injection vehicle that aids in suspension of
`
`microparticles (Ex.1024 ¶107), and that a POSA could combine Ramstack’s
`
`risperidone with the microparticles and injectable suspension of Gustafsson with a
`
`reasonable expectation of success (Ex.1024 ¶112). It is obvious to combine prior
`
`15
`
`
`
`Case IPR2016-01096
`Patent No. 6,667,061
`Resp. POs’ Observations on Cross-Examination of Patrick DeLuca, Ph.D.
`Attorney Docket No. 9LUYE 7.1R-004
`
`art elements according to known methods to yield predictable results. KSR Int’l
`
`Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007).
`
`Response To Observation 19:
`
`The cited testimony of Dr. DeLuca lacks foundation, is
`
`irrelevant,
`
`incomplete, and does not “contradict[] any motivation to replace or modify
`
`Ramstack’s microspheres or vehicle.” (Mot. 8.) Dr. DeLuca testified that based on
`
`the prior art, a POSA would know how to choose a suitable viscosity to balance
`
`suspendability and injectability (Ex.2081, at 9:11-23, 15:15-16:9, 38:24-39:3,
`
`154:23-155:12) and how to choose a suitable vehicle (id. 41:8-20). Further,
`
`Dr. DeLuca’s prior testimony explains that Gustafsson teaches that any active may
`
`be used in its formulation, which includes an injection vehicle that aids in
`
`suspension of microparticles, and that a POSA would use either Ramstack’s
`
`microparticles in Gustafsson’s vehicle or Ramstack’s risperidone in Gustafsson’s
`
`microparticles and vehicle. (Pet. 39, 45-47; Ex.1002 ¶¶ 78, 80; Ex.1024 ¶106.) It is
`
`obvious to combine prior art elements according to known methods to yield
`
`predictable results. KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007).
`
`Response To Observation 20:
`
`The cited testimony of Dr. DeLuca is irrelevant, incomplete, and does not
`
`“contradict[] Petitioners’ assertion that a POSA would be motivated to combine
`
`16
`
`
`
`Case IPR2016-01096
`Patent No. 6,667,061
`Resp. POs’ Observations on Cross-Examination of Patrick DeLuca, Ph.D.
`Attorney Docket No. 9LUYE 7.1R-004
`
`components of Ramstack with Gustafsson’s
`
`injection vehicle.” (Mot. 8.)
`
`Dr. DeLuca testified that based on the prior art, a POSA would know how to
`
`choose a suitable viscosity to balance suspendability and injectability (Ex.2081,
`
`at 9:11-23, 15:15-16:9, 38:24-39:3, 154:23-155:12) and how to choose a suitable
`
`vehicle (id. 41:8-20). Further, Dr. DeLuca’s prior testimony explains that
`
`Gustafsson teaches that any active may be used in its formulation, which includes
`
`an injection vehicle that aids in suspension of microparticles, and that a POSA
`
`would use either Ramstack’s microparticles in Gustafsson’s vehicle or Ramstack’s
`
`risperidone in Gustafsson’s microparticles and vehicle. (Pet. 39, 45-47; Ex.1002
`
`¶¶ 78, 80; Ex.1024 ¶106.) It is obvious to combine prior art elements according to
`
`known methods to yield predictable results. KSR Int’l Co. v. Teleflex Inc., 550 U.S.
`
`398, 416 (2007).
`
`Response To Observation 21:
`
`The cited testimony of Dr. DeLuca is irrelevant, incomplete, and does not
`
`contradict Petitioners’ assertions that a POSA would combine components of
`
`Ramstack with Gustafsson’s injection vehicle. (Mot. 9.) Dr. DeLuca testified that
`
`based on the prior art, a POSA would know how to choose a suitable viscosity to
`
`balance suspendability and
`
`injectability (Ex.2081, at 9:11-23, 15:15-16:9,
`
`38:24-39:3, 154:23-155:12) and how to choose a suitable vehicle (id. 41:8-20).
`
`17
`
`
`
`Case IPR2016-01096
`Patent No. 6,667,061
`Resp. POs’ Observations on Cross-Examination of Patrick DeLuca, Ph.D.
`Attorney Docket No. 9LUYE 7.1R-004
`
`Further, Dr. DeLuca’s prior testimony explains that Gustafsson teaches that any
`
`active may be used in its formulation, which includes an injection vehicle that aids
`
`in suspension of microparticles, and that a POSA would use either Ramstack’s
`
`microparticles in Gustafsson’s vehicle or Ramstack’s risperidone in Gustafsson’s
`
`microparticles and vehicle. (Pet. 39, 45-47; Ex.1002 ¶¶78, 80; Ex.1024 ¶106.) It is
`
`obvious to combine prior art elements according to known methods to yield
`
`predictable results. KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007).
`
`Response To Observation 22:
`
`The cited testimony of Dr. DeLuca is irrelevant, incomplete, and does not
`
`“contradict[] Petitioners’ assertion that Ramstack and Gustafsson would be
`
`combined.” (Mot. 9.) Dr. DeLuca testified that based on the prior art, a POSA
`
`would know how to choose a suitable viscosity to balance suspendability and
`
`injectability (Ex.2081, at 9:11-23, 15:15-16:9, 38:24-39:3, 154:23-155:12) and
`
`how to choose a suitable vehicle (id. 41:8-20). Further, Dr. DeLuca’s prior
`
`testimony explains that Gustafsson teaches that any active may be used in its
`
`formulation, which includes an injection vehicle that aids in suspension of
`
`microparticles, and that a POSA would use either Ramstack’s microparticles in
`
`Gustafsson’s vehicle or Ramstack’s risperidone in Gustafsson’s microparticles and
`
`vehicle. (Pet. 39, 45-47; Ex.1002 ¶¶78, 80; Ex.1024 ¶106.) It is obvious to
`
`18
`
`
`
`Case IPR2016-01096
`Patent No. 6,667,061
`Resp. POs’ Observations on Cross-Examination of Patrick DeLuca, Ph.D.
`Attorney Docket No. 9LUYE 7.1R-004
`
`combine prior art elements according to known methods to yield predictable
`
`results. KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007).
`
`Response To Observation 23:
`
`The cited
`
`testimony of Dr. DeLuca
`
`is mischaracterized,
`
`irrelevant,
`
`incomplete, and does not “contradict[] Petitioners’ assertion that Ramstack and
`
`Gustafsson would be combined.” (Mot. 9.) Dr. DeLuca testified that Gustafsson
`
`was “focused on avoiding the problem that’s created by dispersing this sensitive
`
`active in PLG[A] an organic solvent,” meaning the BSA. (Ex.2081, at 221:11-16.)
`
`Thus, Dr. DeLuca’s testimony and Gustafsson’s teaching of denaturing relate to
`
`BSA. Furthermore, DeLuca testified that based on the prior art, a POSA would
`
`know how to choose a suitable viscosity to balance suspendability and injectability
`
`(id. 9:11-23, 15:15-16:9, 38:24-39:3, 154:23-155:12) and how to choose a suitable
`
`vehicle (id. 41:8-20). Dr. DeLuca’s prior testimony explains that Gustafsson
`
`teaches that any active may be used in its formulation, which includes an injection
`
`vehicle that aids in suspension of microparticles, and that a POSA would use either
`
`Ramstack’s microparticles in Gustafsson’s vehicle or Ramstack’s risperidone in
`
`Gustafsson’s microparticles and vehicle. (Pet. 39, 45-47; Ex.1002 ¶¶78, 80;
`
`Ex.1024 ¶106.) It is obvious to combine prior art elements according to known
`
`19
`
`
`
`Case IPR2016-01096
`Patent No. 6,667,061
`Resp. POs’ Observations on Cross-Examination of Patrick DeLuca, Ph.D.
`Attorney Docket No. 9LUYE 7.1R-004
`
`methods to yield predictable results. KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398,
`
`416 (2007).
`
`Response To Observation 24:
`
`The cited
`
`testimony of Dr. DeLuca
`
`is mischaracterized,
`
`irrelevant,
`
`incomplete, and does not contradict Petitioners’ asserted motivations to combine
`
`the teachings of Kino and Johnson to arrive at claims 4, 5, 10, and 11. (Mot. 10.)
`
`Dr. DeLuca actually testified that density is “not necessary to really worry about”
`
`because “formulating a suspension that’s pretty standard microparticle in a vehicle
`
`for injection purposes, . . . a POSA would know from the prior art how to go about
`
`that to suspend it so that its injectable.” (Ex.2081, at 41:8-14.) Dr. DeLuca also
`
`testified that “[t]he importance of the density is with regard to sedimentation.” (Id.
`
`33:15-17.) “[I]f you could minimize the density, the difference between the density
`
`of the particle and the density of the vehicle, then you retard or minimize the
`
`settling rate.” (Id. 33:17-23.) Further, Dr. DeLuca’s prior testimony explains that
`
`“[a] POSA, reading Kino, would appreciate that sorbitol would increase the density
`
`of an injectable suspension” and that this increase would stabilize the formulation.
`
`(Pet. 27; see also Ex.1002 ¶62.)
`
`20
`
`
`
`Case IPR2016-01096
`Patent No. 6,667,061
`Resp. POs’ Observations on Cross-Examination of Patrick DeLuca, Ph.D.
`Attorney Docket No. 9LUYE 7.1R-004
`
`V. VISCOSITY IS A CONSEQUENCE OF SUSPENDABILITY
`Response To Observation 25:
`
`The cited testimony of Dr. DeLuca is irrelevant, incomplete, and does not
`
`“contradict[] Petitioners’ assertion that suspendability would motivate a POSA to
`
`increase viscosity.” (Mot. 10.) Dr. DeLuca testified that a POSA’s “job is to make
`
`sure that something can be suspended and injected through the needle . . . into the
`
`patient.” (Ex.2081, at 11:19-12:2 (emphasis added); see also 12:10-16 (“he’s going
`
`to want to make sure it’s suspendable and injectable over a given period of time.”),
`
`9:11-23 (“So that’s the purpose, the function of the suspen
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