Case IPR2016-01096
`Patent No. 6,667,061
`Petitioners’ Resp. to POs’ Identification of Portions of Petitioners’ Reply . . .
`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
`__________________________________________________________________
`
`PETITIONERS’ RESPONSE TO PATENT OWNERS’ IDENTIFICATION
`OF PORTIONS OF PETITIONERS’ REPLY ALLEGED TO EXCEED
`THE PROPER SCOPE OF REPLY OR RAISE NEW ARGUMENTS
`
`
`Mail Stop: Patent Board
`Patent Trial and Appeal Board
`U.S. Patent And Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`5066226_1.docx
`
`
`Patent No. 6,667,061
`Petitioners’ Resp. to POs’ Identification of Portions of Petitioners’ Reply . . .
`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
`__________________________________________________________________
`
`PETITIONERS’ RESPONSE TO PATENT OWNERS’ IDENTIFICATION
`OF PORTIONS OF PETITIONERS’ REPLY ALLEGED TO EXCEED
`THE PROPER SCOPE OF REPLY OR RAISE NEW ARGUMENTS
`
`
`Mail Stop: Patent Board
`Patent Trial and Appeal Board
`U.S. Patent And Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`5066226_1.docx
`
`
`
`Case IPR2016-01096
`Resp. to POs’ Identification of Portions of Petitioners’ Reply . . .
`Patent No. 6,667,061
`Attorney Docket No. 9LUYE 7.1R-004
`Pursuant to the Board’s conference call of June 30, 2017, and the parties’
`
`agreement (Ex.2080), Petitioners submit a responsive numbered list of citations to
`
`the record
`
`that provide support for where
`
`the arguments
`
`identified by
`
`Patent Owners were previously raised by Petitioners, or citations to arguments by
`
`Patent Owners to which the objected-to portions are properly responsive.
`
`I.
`
`PETITIONERS DID NOT NEWLY DEFINE THE
`INJECTION VEHICLE OF GUSTAFSSON OR JOHNSON
`Patent Owners:
`1.
`Reply at 8-11, 18-19; Exs.1024 at ¶¶ 31-35, 40-45, 50-52, 86-89. Petitioners
`
`attempt to newly define the Gustafsson injection vehicle and make new arguments
`
`about how a POSA would have allegedly understood the disclosure.
`
`Petitioners’ Response:
`
`Petitioners asserted in the Petition that Gustafsson’s vehicle uses 3% CMC
`
`and referred to the Tracy Declaration to support the assertion that Gustafsson’s
`
`vehicle provides the same viscosity as the ’061 Patent (Pet. 39-40; Ex.1002 ¶70).
`
`In response to Patent Owners’ arguments to the contrary, e.g., that Gustafsson
`
`“does not mention viscosity, specify viscosity of the injection vehicle or the
`
`particular grade or type of CMC used, and does not describe how the injection
`
`vehicle or CMC is prepared” (POR 36) and statements regarding the testing data
`
`
`
`
`
`
`
`Case IPR2016- 01096
`Resp. to POs’ Identification of Portions of Petitioners’ Reply . . .
`Patent No. 6,667,061
`Attorney Docket No. 9LUYE 7.1R-004
`
`included in Exhibit 2059, which only used ultra-low and extra-low viscosity CMC
`
`(POR 37-38, Exs.2014 ¶¶40-41, 112-124; 2059 ¶¶5-12), Petitioners replied with
`
`the arguments now challenged by Patent Owners (Reply 8-11, 18-19; Ex.1024
`
`¶¶31-35, 40-45, 50-52, 86-89).
`
`Patent Owners:
`2.
`Reply at 8-14; Exs.1024 at ¶¶ 31-35, 40-45, 50-54, 57-60, 65. Petitioners
`
`attempt to newly define the Johnson injection vehicle and make new arguments
`
`about how a POSA would have allegedly understood the disclosure.
`
`Petitioners’ Response:
`
`Petitioners asserted in the Petition that Johnson’s vehicle uses low viscosity
`
`CMC (Pet. 24; Ex.1002 ¶59) and referred to the Tracy Declaration to support the
`
`assertion that Johnson’s vehicle provides the same viscosity as the ’061 Patent
`
`(Pet. 17-18; Ex.1002 ¶44). In response to Patent Owners’ arguments to the
`
`contrary, e.g., that “Johnson does not indicate the grade or type of CMC” (POR 21;
`
`Ex.2014 ¶¶51-56), that Petitioners “failed to show that . . . the vehicle would
`
`inherently have a viscosity within the claimed range,” (POR 21-24; Ex.2014
`
`¶¶60-61) and statements regarding the testing data included in Exhibit 2059, which
`
`only used ultra-low and extra-low viscosity CMC (POR 16-24; Exs.2014 ¶¶47-50,
`
`2
`
`
`
`Case IPR2016- 01096
`Resp. to POs’ Identification of Portions of Petitioners’ Reply . . .
`Patent No. 6,667,061
`Attorney Docket No. 9LUYE 7.1R-004
`
`77-81, 87; 2059 ¶¶5-12), Petitioners replied with the arguments now challenged by
`
`Patent Owners (Reply 8-14; Exs.1024 ¶¶31-35, 40-45, 50-54, 57-60, 65).
`
`II.
`
`PETITIONERS DID NOT PROVIDE NEW
`THEORIES REGARDING THE MICROPARTICLE
`AND POLYMERIC BINDER LIMITATIONS
`
`3. Patent Owners:
`Reply at 6-8, 17-22; Exs.1024 at ¶¶ 25-30, 91-97, 100-102, 104; 1036, 1037;
`
`1043. Petitioners assert new theories as to how Gustafsson allegedly satisfies the
`
`microparticle and polymeric binder limitations of the claims of the ’061 patent,
`
`including newly arguing that starch satisfies the limitations.
`
`Petitioners’ Response:
`
`Petitioners asserted in the Petition that Gustafsson teaches that PLGA is a
`
`useful polymeric binder (Pet. 45; Ex.1002 ¶78), teaches 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 Ramstack’s microparticles in
`
`Gustafsson’s vehicle (Pet. 39, 45-47; Ex.1002 ¶¶78, 80). The Board agreed
`
`(Institution Decision 30), and in response to Patent Owners’ arguments to the
`
`contrary, e.g., that the active agent of Gustafsson is not entrapped in a polymer
`
`(POR 40) and that “starches are not polymers” (POR 42), Petitioners replied with
`
`3
`
`
`
`Case IPR2016- 01096
`Resp. to POs’ Identification of Portions of Petitioners’ Reply . . .
`Patent No. 6,667,061
`Attorney Docket No. 9LUYE 7.1R-004
`
`the arguments now challenged by Patent Owners (Reply 6-8, 17-22; Exs.1024
`
`¶¶25-30, 91-97, 100-102, 104; 1036, 1037; 1043).
`
`Patent Owners:
`4.
`Reply at 7-8, 19, 21-24; Exs.1024 at ¶¶ 30, 91, 93-94, 96, 100, 104; 1036.
`
`Petitioners assert new theories that the PLGA coating of Gustafsson satisfies the
`
`microparticle and/or polymeric binder limitations for claims 1-3, 6-9, 12-13, 20-21,
`
`and 22-23.
`
`Petitioners’ Response:
`
`Petitioners asserted in the Petition that microparticles are particles that
`
`include “an active agent or other substance dispersed or dissolved within a polymer
`
`(Pet. 20, Exs.1001, at 5:15-18; 1002 ¶48) and that Gustafsson teaches that PLGA is
`
`a useful polymeric binder (Pet. 45; Ex.1002 ¶78). In response to Patent Owners’
`
`arguments to the contrary, e.g., that Gustafsson taught away from using a
`
`microparticle comprising a polymeric binder (POR 39-42), Petitioners replied with
`
`the arguments now challenged by Patent Owners (Reply 7-8, 19, 21-24; Exs.1024
`
`¶¶ 30, 91, 93-94, 96, 100, 104; 1036).
`
`4
`
`
`
`Case IPR2016- 01096
`Resp. to POs’ Identification of Portions of Petitioners’ Reply . . .
`Patent No. 6,667,061
`Attorney Docket No. 9LUYE 7.1R-004
`
`III. PETITIONERS DID NOT ARGUE NEW COMBINATIONS
`Patent Owners:
`5.
`Ex.1024, ¶101. Petitioners assert a new theory that a POSA would have
`
`combined the microparticles of Ramstack with the injection vehicle of Gustafsson
`
`to arrive at claims 17-19.
`
`Petitioners’ Response:
`
`Petitioners asserted in the Petition that a POSA would expect to combine the
`
`risperidone microspheres of Ramstack with the injection vehicle of Gustafsson
`
`(Pet. 46-47; Ex.1002 ¶80). The Board agreed (Institution Decision 30), and in
`
`response to Patent Owners’ arguments to the contrary, e.g., that a POSA would not
`
`have selected Gustafsson for delivering risperidone microparticles and have no
`
`reason to combine Gustafsson and Ramstack (POR 49-57), Petitioners replied with
`
`the arguments now challenged by Patent Owners (Reply 24, 26; Ex.1024 ¶101).
`
`6. Patent Owners:
`Reply at 20; Exs.1024 at ¶¶ 95, 102; 1043; 1011 at 3:31-36. Petitioners
`
`assert a new theory that a POSA would have combined the microparticles of
`
`WO 90/13780 (Ex.1043), a newly asserted prior art reference, with the injection
`
`vehicle of Example 6 in Gustafsson to arrive at claims 17-19 and assert that a
`
`5
`
`
`
`Case IPR2016- 01096
`Resp. to POs’ Identification of Portions of Petitioners’ Reply . . .
`Patent No. 6,667,061
`Attorney Docket No. 9LUYE 7.1R-004
`
`POSA would do so because Gustafsson allegedly “acknowledges that any
`
`microparticle can be used.” (Ex.1024 at ¶ 102.)
`
`Petitioners’ Response:
`
`Petitioners asserted in the Petition 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 Ramstack’s
`
`microparticles in Gustafsson’s vehicle (Pet. 39, 45-47; Ex.1002 ¶¶78, 80). The
`
`Board agreed (Institution Decision 30), and in response to Patent Owners’
`
`arguments to the contrary, e.g., that Gustafsson taught away from using a
`
`microparticle of the ’061 Patent (POR 39-44), Petitioners replied with the
`
`arguments now challenged by Patent Owners, which point out that Gustafsson also
`
`teaches PLGA-matrix microparticles by reference to WO 90/13780 (Ex.1043)
`
`(Reply 20; Exs.1024 ¶¶ 95, 102; 1043; 1011, at 3:31-36).
`
`7. Patent Owners:
`Reply at 23-26; Ex.1024 at ¶¶ 106-112. Petitioners assert a new theory that a
`
`POSA could combine the risperidone active of Ramstack with the microparticles
`
`and injection vehicle of Gustafsson to arrive at claims 20-21.
`
`
`
`
`
`6
`
`
`
`Case IPR2016- 01096
`Resp. to POs’ Identification of Portions of Petitioners’ Reply . . .
`Patent No. 6,667,061
`Attorney Docket No. 9LUYE 7.1R-004
`
`
`Petitioners’ Response:
`
`Petitioners asserted in the Petition that Gustafsson teaches any active may be
`
`used in its formulation, which teaches 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). The Board agreed (Institution
`
`Decision 30), and in response to Patent Owners’ arguments to the contrary, e.g.,
`
`that there is no motivation to combine Gustafsson and Ramstack (POR 52-57) and
`
`that Gustafsson’s reservoir-type microparticles containing BSA differ from
`
`Ramstack’s PLGA-matrix-type microparticles containing risperidone (POR 56),
`
`Petitioners replied with the arguments now challenged by Patent Owners
`
`(Reply 23-26; Ex.1024 ¶¶106-112).
`
`IV. PETITIONERS DID NOT PROVIDE A NEW ARGUMENT
`REGARDING THE DENSITY ENHANCING AGENT LIMITATION
`8. Patent Owners:
`Ex.1024 at ¶¶73-78. Petitioners assert new theories as to how Kino allegedly
`
`satisfies the density enhancing agent limitation of claims 4, 5, 10 and 11 of the
`
`’061 patent, including newly arguing that the sorbitol added to the Kino
`
`7
`
`
`
`Case IPR2016- 01096
`Resp. to POs’ Identification of Portions of Petitioners’ Reply . . .
`Patent No. 6,667,061
`Attorney Docket No. 9LUYE 7.1R-004
`
`microparticle would dissolve into, and thus become part of the injection vehicle
`
`when the composition is reconstituted.
`
`Petitioners’ Response:
`
`Petitioners asserted in the Petition 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; Ex.1002 ¶62). In
`
`response to Patent Owners’ arguments to the contrary in the Patent Owners’
`
`response, e.g., that Kino taught including sorbitol before freezing to stabilize the
`
`microsphere (POR 30), Petitioners replied with the arguments now challenged by
`
`Patent Owners (Reply 17; Ex.1024 ¶¶73-78).
`
`V.
`
`PETITIONERS DID NOT PROVIDE A NEW
`ARGUMENT REGARDING MOTIVATION TO COMBINE
`9. Patent Owners:
`Reply at 17; Ex.1024 at ¶ 76. Petitioners newly assert that a POSA would
`
`have been motivated to combine the teachings of Kino and Johnson in order to
`
`minimize the difference between the densities of the particles and the vehicle to
`
`reduce sedimentation to arrive at claims 4, 5, 10 and 11.
`
`8
`
`
`
`Case IPR2016- 01096
`Resp. to POs’ Identification of Portions of Petitioners’ Reply . . .
`Patent No. 6,667,061
`Attorney Docket No. 9LUYE 7.1R-004
`
`
`Petitioners’ Response:
`
`Petitioners asserted in the Petition 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; Ex.1002 ¶62). In
`
`response to Patent Owners’ arguments to the contrary, e.g., that increasing the
`
`density would minimize the difference between the densities of the particles and
`
`the vehicle and thereby reduce sedimentation (POR 31; Ex.2014 ¶100), Petitioners
`
`replied with the arguments now challenged by Patent Owners (Reply 17; Ex.1024
`
`¶76).
`
`10. Patent Owners:
`Reply at 22-26; Ex.1024 at ¶¶ 103-112. Petitioners newly assert that a POSA
`
`would have been motivated to combine Gustafsson and Ramstack to arrive at
`
`claims 20 and 21 since a POSA would have been motivated by the common and
`
`interchangeable components of Gustafsson and Ramstack to combine these
`
`references.
`
`Petitioners’ Response:
`
`Petitioners asserted in the Petition that Gustafsson teaches that any active
`
`may be used in its formulation, which teaches an injection vehicle that aids in
`
`suspension of microparticles, and
`
`that a POSA would use Ramstack’s
`
`9
`
`
`
`Case IPR2016- 01096
`Resp. to POs’ Identification of Portions of Petitioners’ Reply . . .
`Patent No. 6,667,061
`Attorney Docket No. 9LUYE 7.1R-004
`
`microparticles in Gustafsson’s vehicle (Paper 5 pp.39, 45-47). The Board agreed
`
`(Paper 13 p.30), and in response to Patent Owners’ arguments to the contrary, e.g.,
`
`that there is no motivation to combine Gustafsson and Ramstack (POR 7, 41, 56),
`
`Petitioner’s replied with the arguments now challenged by Patent Owners
`
`(Reply 22-26; Ex.1024 ¶¶103-112).
`
`VI. PETITIONERS DID NOT PROVIDE A
`NEW ARGUMENT REGARDING THE
`MOTIVATIONS AND KNOWLEDGE OF A POSA
`11. Patent Owners:
`Reply at 4-6, 15; Exs.1024 at ¶¶ 14-24; 1028; 1032; 1034. Petitioners newly
`
`assert that a POSA would have been motivated by suspendability to arrive at
`
`viscosities within the claimed range.
`
`Petitioners’ Response:
`
`The Petition and Dr. DeLuca established that “the formulator must include
`
`various substances such as suspending agents, tonicity agents, wetting agents, etc.
`
`to arrive at a suitable aqueous injection vehicle capable of satisfying the
`
`syringeability and injectability properties required to make a formulation suitable
`
`for injection” (Pet. 9; Ex.1002 ¶¶9, 24, 26, 76), that injectable formulations would
`
`include a suspending agent (Pet. 9, 44; Ex.1002 ¶¶9, 24, 26, 76), and that
`
`“[a]djusting excipients, all of which are known in the art and used for their
`
`10
`
`
`
`Case IPR2016- 01096
`Resp. to POs’ Identification of Portions of Petitioners’ Reply . . .
`Patent No. 6,667,061
`Attorney Docket No. 9LUYE 7.1R-004
`
`well-known functions, to provide a suitable suspendability and distribution of
`
`microparticles for injectability purposes is well within the general knowledge of a
`
`skilled artisan” (Pet. 18-19, 44; Ex.1002 ¶9). In response to Patent Owners’
`
`arguments to the contrary, e.g., that it is an unexpected discovery because
`
`conventional wisdom is to keep viscosity low to make suspensions easier to inject
`
`and that “an increase in viscosity hinders injectability” (POR 5-7, 60; Ex.2016
`
`p.97:2-22), Petitioners replied with arguments now challenged by Patent Owners
`
`(Reply 4-6, 15; Exs.1024 ¶¶14-24; 1028; 1032; 1034).
`
`12. Patent Owners:
`Reply at 2-4; Exs.1024 at ¶¶ 7-24; 1027; 1028; 1030; 1032; 1034. Petitioners
`
`newly assert that viscosities within the claimed range were already known and
`
`would be a product of routine optimization, including newly arguing that a POSA
`
`would have understood Decapeptyl to have a viscosity within the margin of error
`
`of that claimed in the ’061 patent, that aqueous suspensions of risperidone prodrug
`
`with a viscosity within the claimed range could be used as a depot injection, and
`
`that a POSA would not know what constitutes low viscosity for an injection
`
`vehicle at the time of the invention.
`
`11
`
`
`
`Case IPR2016- 01096
`Resp. to POs’ Identification of Portions of Petitioners’ Reply . . .
`Patent No. 6,667,061
`Attorney Docket No. 9LUYE 7.1R-004
`
`
`Petitioners’ Response:
`
`Petitioners asserted in the Petition that the general principles for developing
`
`formulations by improving injectability are well known and well understood and
`
`that the claimed viscosities are within ranges known in the prior art for injectable
`
`suspensions (Pet. 6, 7, 9, 15, Ex.1002 ¶¶16-19, 23, 32; 1008 pp.78, 135, 137, 329,
`
`420, 481). In response to Patent Owners’ arguments to the contrary, e.g., that
`
`Petitioners’ assertions were “in direct contrast to ‘conventional teachings that an
`
`increase in the viscosity hinders injectability and suspendability’” and that the
`
`“inventors in vivo injectability studies showed ‘a dramatic improvement in
`
`injectability with injection vehicle viscosity’” (POR 6-7), Petitioners replied with
`
`arguments now challenged by Patent Owners (Reply 2-4; Exs.1024 ¶¶7-24; 1027;
`
`1028; 1030; 1032; 1034).
`
`
`Dated:
`
`
`
`
`5066226_1.docx
`
`July 21, 2017
`
`
`
`By:
`
`/ Tedd Van Buskirk /
`Tedd W. Van Buskirk
`Reg. No. 46,282
`
`
`
`
`
`
`
`
`
`12
`
`
`
`Case IPR2016-01096
`Resp. to POs’ Identification of Portions of Petitioners’ Reply . . .
`Patent No. 6,667,061
`Attorney Docket No. 9LUYE 7.1R-004
`
`
`CERTIFICATE OF SERVICE
`The undersigned hereby certifies that a true copy of the foregoing
`
`PETITIONERS’ RESPONSE TO PATENT OWNERS’ IDENTIFICATION
`
`OF PORTIONS OF PETITIONERS’ REPLY ALLEGED TO EXCEED THE
`
`PROPER SCOPE OF REPLY OR RAISE NEW ARGUMENTS was served on
`
`July 21, 2017, as follows.
`
`VIA E-MAIL
`
`Scott K. Reed, Esq.
`Fitzpatrick, Cella, Harper & Scinto
`1290 Avenue of the Americas
`New York, NY 10104-3800
`Tel: 212.218.2100
`E-mail:
`sreed@fchs.com
`
`
`July 21, 2017
`
`
`
`By:
`
`/ Tedd Van Buskirk /
`Tedd W. Van Buskirk
`Reg. No. 46,282
`
`
`
`
`
`
`
`
`
`
`
`
`Dated:
`
`
`
`
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