Case No. IPR2018-01055
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`UNITED STATES PATENT AND TRADEMARK OFFICE
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`3M Company, Merck & Co., Inc. and Merck Sharp & Dohme Corp.,
`Petitioners
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`v.
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`Aptar France S.A.S.,
`Patent Owner
`________________________
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`Case IPR2018-01055
`Patent No. 9,370,631
`________________________
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`DECLARATION OF CHARLES E. CLEMENS IN SUPPORT OF PATENT
`OWNER’S SUR-REPLY TO PETITION FOR
`INTER PARTES REVIEW OF U.S. PATENT NO. 9,370,631
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`________________________
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`________________________
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`3M Company, Merck & Co., Inc. and Merck Sharp & Dohme Corp.,
`Petitioners
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`v.
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`Aptar France S.A.S.,
`Patent Owner
`________________________
`
`Case IPR2018-01055
`Patent No. 9,370,631
`________________________
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`DECLARATION OF CHARLES E. CLEMENS IN SUPPORT OF PATENT
`OWNER’S SUR-REPLY TO PETITION FOR
`INTER PARTES REVIEW OF U.S. PATENT NO. 9,370,631
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`I, Charles E. Clemens, declare as follows:
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`I.
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`Introduction
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`1.
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`I have been asked to evaluate and assess certain information in
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`connection with Aptar France S.A.S.’s (“Patent Owner”) Sur-Reply to 3M
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`Company, Merck & Co., Inc. and Merck Sharp & Dohme Corp.’s (collectively,
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`“Petitioners”) Reply, filed on May 13, 2019, in inter partes review of U.S. Patent
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`No. 9,370,631 (“the Petition”). All of the opinions and conclusions found in this
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`declaration are my own.
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`2.
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`I make this declaration as a supplement the other declarations I have
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`submitted in this matter. Specifically, I previously submitted the August 15, 2018
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`Declaration of Charles E. Clemens in Support of Patent Owner’s Preliminary
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`Response (Ex. 2005), the February 13, 2019 Declaration of Charles E. Clemens in
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`Support of Patent Owner’s Response (Ex. 2021), and the March 7, 2019
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`Supplemental Declaration of Charles E. Clemens in Support of Patent Owner’s
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`Response (Ex. 2022). The entirety of those declarations is incorporated herein by
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`reference.
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`II.
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`Petitioners’ Proposed Bason/Rhoades Combination Does Not Disclose a
`“second member” or a “displayed dose value”
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`3.
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`In my declaration dated February 13, 2019, I identified that the
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`combination of Bason and Rhoades would be inoperable for its intended purpose
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`because teeth 2 create a physical barrier that prevents the cap 14 from being
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`1
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`depressed, and because teeth 7 no longer “engage” with teeth 2 in order to rotate
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`the ring 4. To remedy these problems, Petitioners expert, Mr. Piper, replies that
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`Bason’s cap would be “slightly widen[ed] . . . so that its outer edge fits over the
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`outside of the housing,” that “a rib … would [be] added to the outside of the
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`housing … to prevent unintentional removal of the cap,” and that “the diameter of
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`ring 4 [would be extended] so that teeth 7 interact with teeth 2.” Ex. 1058 ¶¶16,
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`23; Reply at 10-11, 15.
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`4.
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`A POSA would not have combined Bason and Rhoades in the new
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`manner described because the resulting device would be inoperable for its intended
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`purpose. First, ring 4 would not rotate to bring a new dose value into window 13
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`because teeth 7 would not contact teeth 14a. Teeth 7 must press down and slide
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`against the surface of the base’s “fixed” teeth 2, and must return upwards to
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`interact with teeth 14a of bush 15, in order for ring 4 to rotate. Ex. 2021 at ¶24
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`(emphasis added). If the diameter of ring 4 is “extended . . . so that teeth 7 interact
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`with teeth 2” (shown below in blue), teeth 7 no longer contact teeth 14a (shown
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`below in purple), which remain situated on the underside of bush 15 and are
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`separated from teeth 7 by the presence of the spring.
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`2
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`“ring 4 [would be extended] so that
`teeth 7 interact with teeth 2.”
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`Ex. 1007 at Fig. 2 (annotated).
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`5.
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`Second, ring 4 would not rotate because central bush 15 is not
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`mounted. Bason teaches that bush 15 is in a non-movable attachment to base 1 via
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`a key way connection. Bonding base 1 to the canister thus allows bush 15 to stay
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`in a “fixed position” as required for teeth 7 to correctly interact with the fixed teeth
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`2/14a in order to achieve ring 4’s relative rotation. Ex. 2021 at ¶¶24, 81.
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`However, Petitioners’ combination of Bason and Rhoades removes base 1 by
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`making teeth 2 integral with the inhaler body, so bush 15 is no longer mounted.
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`Ex. 1002 at ¶138 (“The resulting inhaler would have been predictable, well
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`understood by a POSA, less expensive to manufacture (no need to separately
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`manufacture Bason base 1 and bond it to a canister), and more reliable (fewer parts
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`that need to be manufactured and assembled).”). As a result, bush 15 is permitted
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`to rotate freely, and there is nothing to keep it in a fixed position relative the other
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`3
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`components to effect relative rotation of ring 4. See Ex. 2021 at ¶81. Further, if
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`unmounted, bush 15 cannot support or guide ring 4 so that pawl 5 works with
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`radially inwardly directed kink 26 for counting. Thus, teeth 7 will not properly
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`engage with teeth 2/14a as required to rotate ring 4 to advance the dose values.
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`6.
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`Third, Bason’s dose values would not be visible out of window 13 due
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`to the new extended diameter of ring 4. The dose values are visible out of window
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`13 on the upper faces 24 and 25 of the rotational rings 4 and 8, with ring 8
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`“concentrically disposed above and around” ring 4. Ex. 2021 at ¶23. If ring 4
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`were “extended” to the outer circumference of the cap “so that teeth 7 interact with
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`teeth 2,” then the diameter of ring 4 would be greater than or equal to the diameter
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`of ring 8 and have the effect of disrupting the concentric organization of top
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`surfaces 24 and 25 and displacing the dose values from window 13. Further, if
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`ring 8 is moved to the inside diameter of ring 4, the sequencing of counting and
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`displaying numbers during rotation becomes inoperable. Additionally, the dose
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`values would no longer be visible to a user, and the combination of Bason and
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`Rhoades would be inoperable for its intended purpose.
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`III. Petitioners’ Proposed Bason/Allsop Combination Does Not Disclose a
`“second member” or a “displayed dose value”
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`7.
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`In my declaration dated February 13, 2019, I also identified that the
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`combination of Bason and Allsop would be inoperable for its intended purpose
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`because teeth 2 create a physical barrier that prevents the cap 14 from being
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`4
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`depressed, because teeth 7 no longer “engage” with teeth 2 in order to rotate the
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`ring 4, and because the dose values are not “displayed” or “displayable” out of
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`window 13 if the Bason dose counter is moved below the canister. To remedy
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`these problems, Petitioners expert, Mr. Piper, replies that the “cap would [be]
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`designed with slots through which teeth 2 [] would protrude” which would be
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`“slightly taller than the height of the teeth, allowing the cap to move up and down
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`upon operation of the MDI,” that “a POSA would have . . . taper[ed] teeth 2
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`(narrower at the top, wider at the bottom), to allow the cap to slide into position,”
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`that “the diameter of ring 4 [would be extended] so that teeth 7 interact with teeth
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`2,” and that window 13 would “be made on the side of the device.” Ex. 1058
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`¶¶17-19, 23, 25; Reply at 12-13, 15.
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`8.
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`A POSA would not have combined Bason and Allsop in the new
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`manner described by Mr. Piper because the resulting device would be inoperable
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`for its intended purpose. First, ring 4 would not rotate to bring a new dose value
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`into window 13 because teeth 7 would not contact teeth 14a on bush 15. As
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`previously explained, for ring 4 to rotate, teeth 7 must return upwards to interact
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`with teeth 14a of bush 15. Ex. 2021 at ¶24. Thus, if the diameter of ring 4 is
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`“extended . . . so that teeth 7 interact with teeth 2” then teeth 7 do not contact teeth
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`14a because they are prevented from interacting by the presence of the spring.
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`5
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`9.
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`Second, ring 4 would not rotate because central bush 15 is not
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`mounted. As previously explained, the fixed attachment of bush 15 to base 1,
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`which Bason teaches is “bonded to the domed base” of the canister, is essential to
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`permit teeth 7 to engage with teeth 2/14a to cause relative rotation of ring 4. Ex.
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`1007 at 2:16-19. However, “the base 1 with stationary gear 2 would have been
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`molded directly into the wall of the Bason inhaler” in the new Bason and Allsop
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`combination, so bush 15 cannot mount. Ex. 1002 at ¶174. Because bush 15 cannot
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`mount, it is not “non-moveable.” The resulting free rotation of bush 15 prevents
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`teeth 7 from interfacing with teeth 2/14a to effect the relative rotation of ring 4,
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`and bush 15 cannot support or guide ring 4 so that pawl 5 works with radially
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`inwardly directed kink 26 for counting.
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`10. Third, the new combination of Bason and Allsop would not display a
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`dose value because window 13 cannot be moved to the side of the device as Mr.
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`Piper asserts. As explained in my declaration dated February 13, 2019, relocating
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`window 13 to the side of the device would also necessitate “redesigning the
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`structure of the rings 4 and 8, central bush 15, curved arm 6, pawl 5, downwardly
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`directed wall 12, and radially inwardly directed kink 26.” Ex. 2021 at ¶99. Rings
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`4 and 8 would need to be rotated ninety degrees in orientation and stacked on top
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`of one another so that the dose values appearing on the top surfaces of rings 4 and
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`8 could be viewed out of window 13, as displayed from a horizontal perspective
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`6
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`rather than a vertical perspective. Additionally, curved arm 6 and upwardly
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`directly pawl 5, which act to rotate ring 8, would need to be redesigned as they
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`currently are placed on the outer extremity of the cap (where window 13 would
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`apparently be moved, and where teeth 7 and teeth 2 would purportedly interact).
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`Redesign would also be required for central bush 15, which is loose and
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`unmounted in the Petitioners combination, and would require at least a new
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`bonding process step contradicting the motivation for fewer manufacturing steps.
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`Lastly, downwardly directed wall 12 with kink 26 would physically interfere with
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`newly re-located rings 4 and 8 and be required to be operationally moved and
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`reconfigured to interact with pawl 5. However, even if a POSA redesigned all of
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`these components and their functional interactions, it would still not be possible to
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`relocate window 13 to the “side of the device” because the outer extremity of the
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`cap is consumed by the alleged interaction between teeth 7 on the newly extended
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`diameter of ring 4, with teeth 2 which have been re-located to the inner diameter of
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`the inhaler body.
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`I declare under penalty of perjury under the laws of the United States of America
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`and the State of California that the foregoing is true and correct.
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`Dated: February 13, 2019
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`_________________________
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`Charles E. Clemens
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