3M Company, Merck & Co., Inc.,
`and Merck Sharp & Dohme Corp.
`v.
`AptarFrance S.A.S.
`
`IPR2018-01054 (U.S. Patent No. 8,936,177)
`IPR2018-01055 (U.S. Patent No. 9,370,631)
`
`Petitioners’ Demonstratives
`August 12, 2019 Oral Hearing
`
`Demonstrative Exhibit
`Not Evidence
`
`1
`
`3M Company Exhibit 1078
`Page 1 of 77
`
`
`and Merck Sharp & Dohme Corp.
`v.
`AptarFrance S.A.S.
`
`IPR2018-01054 (U.S. Patent No. 8,936,177)
`IPR2018-01055 (U.S. Patent No. 9,370,631)
`
`Petitioners’ Demonstratives
`August 12, 2019 Oral Hearing
`
`Demonstrative Exhibit
`Not Evidence
`
`1
`
`3M Company Exhibit 1078
`Page 1 of 77
`
`
`
`Introduction
`
`1. Unpatentability of Claims 1-3, 9 and 21 of the ’177 Patent
`
`• Ground 1: Obviousness in view of Elliott + Rhoades
`
`• Ground 2: Obviousness in view of Bason + Rhoades
`
`2. Unpatentability of Claims 1-4 of the ’631 Patent
`
`• Ground 1: Anticipation by Allsop
`
`• Ground 2: Anticipation by Marelli
`
`• Ground 3: Obviousness in view of Bason + Rhoades
`
`• Ground 4: Obviousness in view of Bason + Allsop
`
`Demonstrative Exhibit
`Not Evidence
`
`2
`
`3M Company Exhibit 1078
`Page 2 of 77
`
`
`
`Instituted Grounds of Unpatentability –’177 Patent
`
`Trial instituted for the ’177 Patent (Ex. 1001)
`
`• Ground 1: Claims 1, 2, 3, 9 and 21 are obvious over Elliott
`(Ex. 1006) in view of Rhoades (Ex. 1007).
`
`• Ground 2: Claims 1, 2, 3, 9 and 21 are obvious over Bason
`(Ex. 1005) in view of Rhoades (Ex. 1007).
`
`Institution Decision (Paper 11) at 2
`
`Demonstrative Exhibit
`Not Evidence
`
`3
`
`3M Company Exhibit 1078
`Page 3 of 77
`
`
`
`The ’177 Patent (May 15, 2003)
`
`The claims require:
`
`(1) a fluid dispenser comprising
`
`(2) a dose counter (i.e., a device for
`converting axial to rotational motion)
`
`(3) wherein the dose counter functions
`during incomplete strokes (to prevent
`undercounting)
`
`’177 Patent (Ex. 1001) at Claim 1
`’177 Petition (Paper 1) at 1
`
`Demonstrative Exhibit
`Not Evidence
`
`4
`
`3M Company Exhibit 1078
`Page 4 of 77
`
`
`
`Fluid Dispensers Comprising Dose Counters were
`Disclosed in the Prior Art
`
`Elliott
`
`Elliott (Ex. 1006) at Fig. 3b
`’177 Petition (Paper 1) at 19
`
`• For example, Elliott
`discloses a fluid dispenser
`having a dose counter
`
`’177 Petition (Paper 1) at 17
`Piper Decl. (Ex. 1002) at ¶ 54
`
`• The dose counter is a
`device that converts axial
`motion into rotational
`motion
`
`’177 Petition (Paper 1) at 17
`Piper Decl. (Ex. 1002) at ¶ 54
`
`Elliott (Ex. 1006) at Fig. 1
`’177 Petition (Paper 1) at 18
`
`Demonstrative Exhibit
`Not Evidence
`
`5
`
`3M Company Exhibit 1078
`Page 5 of 77
`
`
`
`Rotating Mechanisms that Function During
`Incomplete Strokes were Disclosed in the Prior Art
`
`Rhoades:
`
`• For example, Rhoades’s cam body rotates before the plunger
`is completely depressed or released
`
`Rhoades (Ex. 1007) at Fig. 4
`’177 Petition (Paper 1) at 23-28
`
`’177 Petition (Paper 1) at 41-46
`Piper Decl. (Ex. 1002) at ¶ 97
`’177 Reply (Paper 28) at 13-20, 22-24
`
`Demonstrative Exhibit
`Not Evidence
`
`6
`
`3M Company Exhibit 1078
`Page 6 of 77
`
`
`
`The FDA Required Manufacturers to Incorporate
`Those Components into MDIs
`
`• The FDA’s 2001 Draft Guidance and 2003 Final Guidance,
`published just two months before Aptar’s priority date, required
`MDIs to (1) integrate dose counters and (2) avoid under-counting
`
`’177 Petition (Paper 1) at 16
`
`• Aptar admits it was simply “answer[ing] the FDA’s call”
`
`’177 Corrected Patent Owner Response (Paper 27) at 3
`
`Ex. 1013 (2003 Final Guidance) at 6; ’177 Petition (Paper 1) at 29
`
`Ex. 1013 (2003 Final Guidance) at 6; ’177 Petition (Paper 1) at 33
`
`Demonstrative Exhibit
`Not Evidence
`
`7
`
`3M Company Exhibit 1078
`Page 7 of 77
`
`
`
`Aptar Filed its Priority Application Two Months
`After FDA’s Final Guidance
`
`’177 Patent (Ex. 1001) at cover
`
`Demonstrative Exhibit
`Not Evidence
`
`8
`
`3M Company Exhibit 1078
`Page 8 of 77
`
`
`
`’177 Patent – Overview of Key Issues
`
`Issues not in dispute
`
`• Fluid dispensers having dose counters were known in the prior art
`
`Issues in dispute:
`
`• Rhoades’s disclosure of “incomplete actuation stroke” limitation
`(independent claim 1)
`
`• Rhoades’s disclosure of “incomplete return stroke” limitations
`(dependent claim 2)
`
`• Rhoades is analogous art
`
`• Motivation to combine
`
`• Operability of combinations
`
`Demonstrative Exhibit
`Not Evidence
`
`9
`
`3M Company Exhibit 1078
`Page 9 of 77
`
`
`
`’177 Ground 1 – Introduction
`
`Elliott
`
`Rhoades
`
`’177 Petition (Paper 1) at 5
`
`• Elliott discloses a fluid
`dispenser with a dose
`counter that converts axial
`motion to rotational motion
`
`’177 Petition (Paper 1) at 17
`
`• Rhoades discloses a fluid
`dispenser having a
`mechanism for converting
`axial to rotational motion
`that rotates upon incomplete
`strokes
`
`’177 Petition (Paper 1) at 41-46
`
`Demonstrative Exhibit
`Not Evidence
`
`10
`
`3M Company Exhibit 1078
`Page 10 of 77
`
`
`
`’177 Ground 2 – Introduction
`
`Bason
`
`Rhoades
`
`’177 Petition (Paper 1) at 6
`
`• Bason discloses a fluid
`dispenser with a dose
`counter that converts axial
`motion to rotational motion
`’177 Petition (Paper 1) at 20
`
`• Rhoades discloses a fluid
`dispenser having a
`mechanism for converting
`axial to rotational motion
`that rotates upon incomplete
`strokes
`
`’177 Petition (Paper 1) at 41-46
`
`Demonstrative Exhibit
`Not Evidence
`
`11
`
`3M Company Exhibit 1078
`Page 11 of 77
`
`
`
`Rhoades Teaches an Incomplete Actuation Stroke
`
`The Rhoades mechanism rotates upon an incomplete depression—
`i.e., an “incomplete actuation stroke”
`
`’177 Petition (Paper 1) at 41-43
`Piper Decl., Ex. 1002 at ¶ 97
`
`Piper Decl., Ex. 1058 at ¶ 37
`’177 Reply (Paper 28) at 13-20
`
`Rhoades (Ex. 1007) at 5:51-54
`’177 Petition (Paper 1) at 42
`
`Demonstrative Exhibit
`Not Evidence
`
`12
`
`3M Company Exhibit 1078
`Page 12 of 77
`
`
`
`Rhoades Teaches an Incomplete Actuation Stroke
`
`Aptar argues: a computer animation on “TheKidShouldSeeThis”
`website shows that Rhoades does not disclose an incomplete
`actuation stroke
`
`’177 Corrected Patent Owner Response (Paper 27) at 19-24
`
`• Aptar presents an irrelevant screenshot from the animation that
`clearly differs from Rhoades
`
`’177 Reply (Paper 28) at 13-18
`Piper Decl. (Ex. 1058) at ¶ 35-37, 39-41
`
`“TheKidShouldSeeThis.com”
`animation
`
`Rhoades
`
`Animation (Ex. 2020) at 1:58, 2:18; ’177 Reply (Paper 28) at 16
`
`Rhoades (Ex. 1007) at Fig. 9; ’177 Reply (Paper 28) at 17
`
`Demonstrative Exhibit
`Not Evidence
`
`13
`
`offset
`
`3M Company Exhibit 1078
`Page 13 of 77
`
`
`
`Rhoades Teaches an Incomplete Actuation Stroke
`
`Even the animation on “TheKidShouldSeeThis.com” is not
`inconsistent with an “incomplete actuation stroke” ’177 Reply (Paper 28) at 14-15
`Piper Decl. (Ex. 1058) at ¶ 36
`
`Petitioners’
`annotation
`
`Aptar’s
`annotation
`
`’177 Reply (Paper 28) at 14-15
`Piper Decl. (Ex. 1058) at ¶ 36
`
`Demonstrative Exhibit
`Not Evidence
`
`14
`
`3M Company Exhibit 1078
`Page 14 of 77
`
`
`
`Rhoades Teaches an Incomplete Return Stroke
`(Claim 2)
`
`• The point where fingers 43 and 44 pass
`the tip of sloped faces 50 and 52 (blue
`circles) is the point of the incomplete
`return stroke
`
`’177 Petition (Paper 1) at 43-46
`Piper Decl. (Ex. 1002) at ¶¶ 102-105
`
`Rhoades (Ex. 1007) at Fig. 11
`’177 Petition (Paper 1) at 45
`
`• The plunger may be further released
`after that point
`
`’177 Petition (Paper 1) at 43-46
`Piper Decl. (Ex. 1002) at ¶¶ 102-105
`
`Rhoades (Ex. 1007) at Fig. 8
`’177 Petition (Paper 1) at 42
`
`Demonstrative Exhibit
`Not Evidence
`
`15
`
`3M Company Exhibit 1078
`Page 15 of 77
`
`
`
`Rhoades Teaches an Incomplete Return Stroke
`(Claim 2)
`
`• To prevent another dispensing of fluid before counter resets, if chamber refills
`with fluid at a distance X from rest, the point of the incomplete return stroke
`would be set to a distance of X+Y
`
`’177 Petition (Paper 1) at 33-34, 44
`Piper Decl. (Ex. 1002) at ¶¶ 102-105
`• Once the fingers clear the blue circles, and even if the fingers are not
`permitted to return to the rest position, depressing the plunger will actuate the
`device
`
`’177 Petition (Paper 1) at 46
`Piper Decl. (Ex. 1002) at ¶ 106
`
`rest
`
`chamber refills
`
`01 3
`
`2
`
`Incomplete return
`stoke
`
`Demonstrative Exhibit
`Not Evidence
`
`16
`
`754
`
`6
`
`8
`9
`10
`
`Rhoades (Ex. 1007) at Fig. 11;
`’177 Petition (Paper 1) at 45; Piper Decl. (Ex. 1002) at ¶ 103
`
`3M Company Exhibit 1078
`Page 16 of 77
`
`
`
`Motivation to Combine: The FDA Guidance
`
`The FDA Guidance required all future MDIs to integrate dose
`counters that would avoid undercounting
`
`’177 Petition (Paper 1) at 30
`Piper Decl. (Ex. 1002) at ¶ 73
`
`FDA Guidance:
`
`2001 Draft Guidance (Ex. 1012) at 5; 2003 Final Guidance (Ex. 1013) at 6; ’177 Petition (Paper 1) at 29
`
`2001 Draft Guidance (Ex. 1012) at 6; 2003 Final Guidance (Ex. 1013) at 6; ’177 Petition (Paper 1) at 33
`
`Demonstrative Exhibit
`Not Evidence
`
`17
`
`3M Company Exhibit 1078
`Page 17 of 77
`
`
`
`Motivation to Combine: Well-Known Mechanisms
`with Same Mechanical Function
`
`• Faced with the need to mass produce MDIs with
`integrated dose counters, A POSA would have looked
`to simple mechanisms that convert axial to rotational
`motion
`
`’177 Petition (Paper 1) at 30, 54
`Piper Decl. (Ex. 1002) at ¶ 73, 136
`
`• A POSA would also have looked to mechanisms that
`were plastic, inexpensive, and mass-produced
`
`’177 Petition (Paper 1) at 30, 54
`Piper Decl. (Ex. 1002) at ¶ 73, 136
`
`Demonstrative Exhibit
`Not Evidence
`
`18
`
`3M Company Exhibit 1078
`Page 18 of 77
`
`
`
`Motivation to Combine: Well-Known Mechanisms
`with Same Mechanical Function
`
`Mr. Piper testified that he relied on the mechanism of a pen when
`asked to build a dose counter for an MDI in 1998
`
`Piper Declaration:
`
`’177 Petition (Paper 1) at 15, 31
`Piper Decl. (Ex. 1002) at ¶¶ 17, 74
`
`’177 Petition (Paper 1) at 15, 31
`Piper Decl. (Ex. 1002) at ¶¶ 17, 74
`
`Demonstrative Exhibit
`Not Evidence
`
`19
`
`3M Company Exhibit 1078
`Page 19 of 77
`
`
`
`Motivation to Combine: Well-Known Mechanisms
`with Same Mechanical Function
`
`Mr. Clemens’s prior testimony contradicts Aptar’s position that a
`POSA designing a medical device would not look to basic
`mechanisms in the art for translating linear to rotational motion
`Clemens’s Prior Testimony (Ex. 1056) at 100; ’177 Reply (Paper 28) at 25
`Mr. Clemens’s testimony in a district court proceeding involving a
`different medical device (an injection device):
`
`* * *
`
`* * *
`
`Clemens’s Prior Testimony (Ex. 1056) at 100; ’177 Reply (Paper 28) at 25
`
`Demonstrative Exhibit
`Not Evidence
`
`20
`
`3M Company Exhibit 1078
`Page 20 of 77
`
`
`
`Motivation to Combine: Well-Known Mechanisms
`with Same Mechanical Function
`
`Mr. Clemens testified in that same district court case that by “basic
`mechanisms” he meant mechanisms that convert linear to rotational
`motion through the use of gears, cams, and springs – the same
`components found in Rhoades
`
`Clemens’s Prior Testimony (Ex. 1056) at 98-100
`’177 Reply (Paper 28) at 25
`
`Mr. Clemens’s testimony in that same district court proceeding
`involving a different medical device (an injection device):
`
`* * *
`
`* * *
`
`* * *
`
`Clemens’s Prior Testimony (Ex. 1056) at 98-99; ’177 Reply (Paper 28) at 25
`
`Demonstrative Exhibit
`Not Evidence
`
`21
`
`3M Company Exhibit 1078
`Page 21 of 77
`
`
`
`Motivation to Combine: Tolerances
`
`Aptar argues: a POSA would not have been motivated to use the
`Rhoades mechanism because it is not suitable for use in a
`precision device requiring strict manufacturing tolerances
`
`’177 Corrected Patent Owner Response (Paper 27) at 32-33
`
`• But “[t]he challenged claims do not require expressly ‘close
`manufacturing tolerances.’”
`
`Institution Decision (Paper 11) at 18
`’177 Reply (Paper 28) at 27
`
`• Moreover, a POSA would have known how to coordinate the
`tolerances to produce a successful device
`
`’177 Petition (Paper 1) at 33, 34
`Piper Decl. (Ex. 1002) at ¶ 19-22, 78
`
`Demonstrative Exhibit
`Not Evidence
`
`22
`
`3M Company Exhibit 1078
`Page 22 of 77
`
`
`
`Motivation to Combine: Tolerances
`
`Aptar argues: Rhoades teaches away from using its mechanism in
`devices requiring close tolerances
`
`’177 Corrected Patent Owner Response (Paper 27) at 32-33
`
`Rhoades passage cited by Aptar:
`
`• But stating that close manufacturing tolerances may not be needed is
`not the same as discouraging the use of close tolerances if desired
`’177 Reply (Paper 28) at 27
`
`Rhoades (Ex. 1007) at 8:14-16
`
`“A reference that merely expresses a general preference
`for an alternative invention but does not criticize, discredit,
`or otherwise discourage investigation into the claimed
`invention does not teach away.”
`
`Meiressone v. Google, Inc., 849 F.3d 1379, 1382 (Fed. Cir. 2017)
`
`Demonstrative Exhibit
`Not Evidence
`
`23
`
`3M Company Exhibit 1078
`Page 23 of 77
`
`
`
`Motivation to Combine: Ease of Use
`
`Aptar argues: a POSA would not have looked to Rhoades
`because it would have resulted in a “double click” inhaler
`’177 Corrected Patent Owner Response (Paper 27) at 24
`
`• Aptar presents insufficient evidence why a “double click”
`mechanism would be inadequate
`
`’177 Corrected Patent Owner Response (Paper 27) at 24
`
`• A “double click” inhaler would have the advantage of avoiding the
`problem of “loss of prime”
`
`’177 Petition (Paper 1) at 35, 59; Piper Decl. (Ex. 1002) at ¶¶ 80, 142
`
`• Mr. Piper testified that a POSA could have easily modified Rhoades
`to implement a single “depress-and-release” MDI
`
`’177 Petition (Paper 1) at 35-36, 59-60
`Piper Decl. (Ex. 1002) at ¶¶ 81, 143
`
`Demonstrative Exhibit
`Not Evidence
`
`24
`
`3M Company Exhibit 1078
`Page 24 of 77
`
`
`
`Motivation to Combine: Ease of Use
`
`Mr. Piper described how a POSA would have implemented the single “depress-
`and-release” alternative:
`
`•
`
`“Rather than two gears with separate heights, a POSA would have simply used a
`single row of teeth, all of the same height, and separately incorporated a second
`row of teeth of the same height to interact with stop members.”
`
`Piper Declaration:
`
`Piper Decl. (Ex. 1002) at ¶ 81
`’177 Petition (Paper 1) at 35-36
`
`Piper Decl. (Ex. 1058) at ¶ 48
`’177 Reply (Paper 28) at 21
`
`Demonstrative Exhibit
`Not Evidence
`
`25
`
`3M Company Exhibit 1078
`Page 25 of 77
`
`
`
`Rhoades is Analogous Art
`
`“Criteria for determining whether prior art is analogous
`may be summarized as (1) whether the art is from the
`same field of endeavor, regardless of the problem
`addressed, and (2) if the reference is not within the field
`of the inventor’s endeavor, whether the reference still is
`reasonably pertinent to the particular problem with
`which the inventor is involved.”
`
`Sci. Plastic Prod., Inc. v. Biotage AB, 766 F.3d 1355, 1359
`(Fed. Cir. 2014)
`
`Demonstrative Exhibit
`Not Evidence
`
`26
`
`3M Company Exhibit 1078
`Page 26 of 77
`
`
`
`Rhoades is Analogous Art
`
`1. Mr. Piper: Around 1998, when asked to build a dose counter for an
`MDI, Mr. Piper “looked to the mechanism of a simple, plastic,
`inexpensive mechanical pen that converted axial motion into
`rotational motion.”
`
`Piper Decl. (Ex. 1002) at ¶ 17
`’177 Petition (Paper 1) at 15
`
`2. Mr. Clemens: Testifying in another IPR regarding a safety device to
`protect needles, Mr. Clemens admitted the device has “simple
`mechanical structures and interfaces . . . [that] can be found in an
`age-old mechanisms of a retractable ball point pen.”
`
`Clemens’s Prior Testimony (Ex. 1055) at ¶ 47
`’177 Reply (Paper 28) at 25
`
`3. Prior Art MDIs: “The device for rotating the rod [of the MDI] is an
`indexing mechanism much like that of a ball-point pen.”
`
`Ambrosio (Ex. 1031) at 2:36-47
`’177 Petition (Paper 1) at 55
`
`Demonstrative Exhibit
`Not Evidence
`
`27
`
`3M Company Exhibit 1078
`Page 27 of 77
`
`
`
`Rhoades is Analogous Art
`
`Mr. Clemens’s prior testimony contradicts Aptar’s position that a
`POSA would not have looked to the Rhoades pen mechanism
`when designing a medical device
`
`’177 Reply (Paper 28) at 25
`
`Mr. Clemens in another IPR proceeding:
`
`Clemens’s Prior Testimony (Ex. 1055) at ¶ 47
`’177 Reply (Paper 28) at 25
`
`Demonstrative Exhibit
`Not Evidence
`
`28
`
`3M Company Exhibit 1078
`Page 28 of 77
`
`
`
`Rhoades is Analogous Art
`
`Ambrosio 1991 discusses a prior art MDI having a mechanism like
`that of a ball-point pen
`
`’177 Petition (Paper 1) at 55;
`Piper Decl. (Ex. 1002) at ¶ 75
`
`Ambrosio 1991:
`
`Demonstrative Exhibit
`Not Evidence
`
`29
`
`Ambrosio (Ex. 1031) at 2:36-47; ’177 Petition (Paper 1) at 55
`
`Demonstrative Exhibit
`Not Evidence
`
`29
`
`3M Company Exhibit 1078
`Page 29 of 77
`
`
`
`The Ground 1 and 2 Combinations are Operable
`
`“A person of ordinary skill is also a person
`of ordinary creativity, not an automaton.”
`
`KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 421 (2007)
`
`’177 Reply (Paper 28) at 1, 4
`
`Demonstrative Exhibit
`Not Evidence
`
`30
`
`3M Company Exhibit 1078
`Page 30 of 77
`
`
`
`The Ground 1 and 2 Combinations are Operable
`
`Aptar discussing the ’177 specification during prosecution:
`
`“One of ordinary skill would understand the structure and connection
`of a body, reservoir, actuator, counter and dispenser member …
`[they] need not be disclosed.”
`
`’177 Prosecution History (Ex. 1004) at 1134; ’177 Reply (Paper 28) at 2; see also ’177 Prosecution
`History (Ex. 1004) at 255, 258-259, 281-285, 1137-1139, 1149-1150, 1158-1166, 1190-1205, 1229-
`1233, 1281:10-1282:1-4, 1292:13-15; ’177 Petition (Paper 1) at 1-2, 10, 13, 62-63; ’177 Reply (Paper
`28) at 2-3, 9, 30
`
`Clemens testifying about the ’177 specification:
`
`Clemens Tr. (Ex. 1077) at 43:23-44:16;
`’177 Sur-Reply (Paper 45) at 3
`
`Demonstrative Exhibit
`Not Evidence
`
`31
`
`3M Company Exhibit 1078
`Page 31 of 77
`
`
`
`The Ground 1 and 2 Combinations are Operable
`
`When an applicant “did not provide the type of detail in
`his specification that he now argues is necessary in
`prior art references, [this] supports [a] finding that [a
`POSA] would have known how to implement the
`features of the references.”
`
`In re Epstein, 32 F.3d 1559, 1568 (Fed. Cir. 1994)
`
`’177 Reply (Paper 28) at 1, 4
`
`Demonstrative Exhibit
`Not Evidence
`
`32
`
`3M Company Exhibit 1078
`Page 32 of 77
`
`
`
`The Ground 1 and 2 Combinations are Operable:
`Snap-Fit Assembly
`
`Aptar argues: the Ground 1 and 2 combinations would be
`inoperable because the cam body could not have been snap-fit
`past the stop members
`
`’177 Corrected Patent Owner Response (Paper 27) at 37-38
`’177 Sur-Reply (Paper 31) at 4-5
`
`• But Mr. Clemens admitted that the use of snap-fits to connect the
`components of medical devices was known
`Clemens Tr. (Ex. 1077) at 55:11-56:18, 71:3-7
`’177 Sur-Sur-Reply (Paper 45) at 4-5
`
`Mr. Clemens:
`
`* * *
`
`Clemens Tr. (Ex. 1077) at 55:11-
`56:18, 71:3-7;
`’177 Sur-Sur-Reply (Paper 45)
`at 4-5
`
`Demonstrative Exhibit
`Not Evidence
`
`33
`
`3M Company Exhibit 1078
`Page 33 of 77
`
`
`
`The Ground 1 and 2 Combinations are Operable:
`Injection Molding
`
`Aptar argues: the Ground 1 and 2 combinations would be inoperable
`because no suitable injection molding tooling design existed to make them
`
`’177 Corrected Patent Owner Response (Paper 27) at 37-38
`
`• But the 1994 treatise cited by Aptar describes how a POSA would have
`designed the injection molding tool
`
`’177 Reply (Paper 28) at 6
`Injection Molding Treatise (Ex. 2018) at 99
`
`’177 Reply (Paper 28) at 6
`Piper Dec. (Ex. 1058) at ¶ 11
`
`Injection Molding Treatise (Ex. 2018) at 99
`’177 Reply (Paper 28) at 6
`
`Demonstrative Exhibit
`Not Evidence
`
`34
`
`3M Company Exhibit 1078
`Page 34 of 77
`
`
`
`The Ground 1 and 2 Combinations are Operable:
`Injection Molding
`
`Aptar argues: the injection molding tool would be cost prohibitive
`
`’177 Sur-Reply (Paper 31) at 7
`
`• But Aptar’s cited 1994 treatise teaches that this design, which has a slot in
`the line of draw, would eliminate added tooling cost
`
`’177 Reply (Paper 28) at 6
`Injection Molding Treatise (Ex. 2018) at 99
`Clemens Tr. (Ex. 1077) at 22:23-23:11
`’177 Sur-Sur-Reply (Paper 45) at 2
`
`Aptar’s Cited 1994 Treatise:
`
`’177 Sur-Sur-Reply (Paper 45) at 2
`Injection Molding Treatise (Ex. 2018) at 99
`
`Demonstrative Exhibit
`Not Evidence
`
`35
`
`3M Company Exhibit 1078
`Page 35 of 77
`
`
`
`The Ground 1 and 2 Combinations are Operable:
`Injection Molding
`
`Mr. Clemens agreed that the relevant tool included a slot in the line
`of draw
`
`’177 Sur-Sur-Reply (Paper 45) at 2
`Clemens Tr. (Ex. 1077) at 22:23-23:11
`
`Mr. Clemens:
`
`. . .
`
`* * *
`
`Clemens Tr. (Ex. 1077) at 22:23-23:11
`
`Demonstrative Exhibit
`Not Evidence
`
`36
`
`3M Company Exhibit 1078
`Page 36 of 77
`
`
`
`The Ground 1 and 2 Combinations are Operable:
`Injection Molding
`
`Aptar argues: the Ground 1 and 2 combinations are inoperable because the
`tooling design would interfere with the inhalation flow path
`
`’177 Corrected Patent Owner Response (Paper 27) at 12
`’177 Sur-Reply (Paper 31) at 5-6
`
`• But Mr. Clemens admitted a
`POSA would have known
`how to set a proper
`inhalation flow path
`
`’177 Sur-Sur-Reply (Paper 45) at 3-4
`
`* * *
`
`. . .
`
`* * *
`
`Clemens Tr. (Ex. 1077) at 38:24-40:7
`
`Demonstrative Exhibit
`Not Evidence
`
`37
`
`3M Company Exhibit 1078
`Page 37 of 77
`
`
`
`The Ground 1 and 2 Combinations are Operable:
`Injection Molding
`
`Mr. Clemens admits that the ’177 specification lacks the type of detail for setting
`a proper inhalation flow path that he argues is necessary in the prior art
`
`Mr. Clemens:
`
`Clemens Tr. (Ex. 1057) at 137:16-138:16
`’177 Reply (Paper 28) at 7
`
`* * *
`
`When an applicant “did not provide the type of detail in his specification
`that he now argues is necessary in prior art references, [this] supports [a]
`finding that [a POSA] would have known how to implement the features of
`the references.” In re Epstein, 32 F.3d 1559, 1568 (Fed. Cir. 1994).
`
`Demonstrative Exhibit
`Not Evidence
`
`38
`
`3M Company Exhibit 1078
`Page 38 of 77
`
`
`
`The Ground 1 Combination is Operable:
`Placement of Spring
`
`Aptar argues: a POSA would not have known how to locate a biasing spring
`in the Elliott / Rhoades combination
`
`’177 Corrected Patent Owner Response (Paper 27) at 15-17
`
`Mr. Clemens:
`
`• But Mr. Clemens admits that the
`’177 specification lacks the type
`of detail for properly locating a
`spring that he argues is
`necessary in the prior art
`
`Clemens Tr. (Ex. 1077) at 102:25-103:15
`’177 Sur-Sur-Reply (Paper 45) at 7
`
`Clemens Tr. (Ex. 1077) at 102:25-103:15
`
`Demonstrative Exhibit
`Not Evidence
`
`39
`
`3M Company Exhibit 1078
`Page 39 of 77
`
`
`
`The Ground 2 Combination is Operable:
`Rotation of Canister Relative to Valve Stem
`
`Aptar argues: the Bason / Rhoades combination is inoperable because a
`canister cannot rotate relative to the valve stem
`’177 Corrected Patent Owner Response
`(Paper 27) at 38-39
`• But Mr. Piper explained why Aptar is incorrect and proved that prior art
`canisters rotated relative to the valve stem
`
`’177 Reply (Paper 28) at 11
`Piper Decl. (Ex. 1058) at ¶¶ 21-29
`
`Prior Art MDI
`
`Piper Decl. (Ex. 1058) at ¶¶ 21-29; ’177 Reply (Paper 28) at 11
`
`Demonstrative Exhibit
`Not Evidence
`
`40
`
`3M Company Exhibit 1078
`Page 40 of 77
`
`
`
`The Ground 2 Combination is Operable:
`Rotation of Canister Relative to Valve Stem
`
`Mr. Piper demonstrated that prior art canisters rotated relative to the
`valve stem
`
`’177 Reply (Paper 28) at 11
`Piper Decl. (Ex. 1058) at ¶¶ 21-29
`
`Albuterol MDI Demonstration (Ex. 1060):
`
`1. Lines aligned on valve and canister
`
`3. Lines no longer aligned
`
`2. Rotation of canister
`
`Piper Decl. (Ex. 1058) at ¶¶ 21-29
`’177 Reply (Paper 28) at 11
`
`Demonstrative Exhibit
`Not Evidence
`
`41
`
`3M Company Exhibit 1078
`Page 41 of 77
`
`
`
`There Was No Long-Felt Need
`
`Aptar admitted that it responded to a shortly felt regulatory
`requirement
`
`’177 Corrected Patent Owner Response (Paper 27) at 51
`
`• Aptar admitted that in developing its alleged invention it “set out to
`answer the FDA’s call”
`
`’177 Corrected Patent Owner Response (Paper 27) at 3
`’177 Reply (Paper 28) at 28
`
`• Aptar has not sufficiently shown that there was a persistent, unmet
`need
`
`’177 Reply (Paper 28) at 28-30
`
`“Ecolochem’s process was developed not in response
`to a long-felt need in the power industry, but in
`response to a shortly felt requirement imposed by
`EPRI’s guidelines.”
`
`Ecolochem, Inc. v. S. Cal. Edison Co., 227 F.3d 1361, 1377
`(Fed. Cir. 2000)
`
`Demonstrative Exhibit
`Not Evidence
`
`42
`
`3M Company Exhibit 1078
`Page 42 of 77
`
`
`
`There Was No Failure of Others
`
`Aptar argues: “drug makers (including Petitioners) failed to
`create an accurate MDI dose counter”
`’177 Corrected Patent Owner Response (Paper 27) at 51
`
`• But Aptar fails to identify any evidentiary support for its conclusory
`assertion that anyone, let alone Petitioners, tried and failed to
`create an accurate MDI dose counter with the claimed features
`
`’177 Reply (Paper 28) at 30
`
`The mere absence of a certain product in the
`marketplace is not evidence of failure of
`others.
`
`Iron Grip Barbell Co. v. USA Sports, Inc., 392 F.3d
`1317, 1324-25 (Fed. Cir. 2004)
`
`Demonstrative Exhibit
`Not Evidence
`
`43
`
`3M Company Exhibit 1078
`Page 43 of 77
`
`
`
`Instituted Grounds of Unpatentability – ’631 Patent
`
`Trial instituted for the ’631 Patent (Ex. 1001)
`
`• Ground 1: Claims 1-4 are anticipated by Allsop (Ex. 1006).
`
`• Ground 2: Claims 1-4 are anticipated by Marelli (Ex. 1008).
`
`• Ground 3: Claims 1-4 are obvious over Bason (Ex. 1007) in
`view of Rhoades (Ex. 1009).
`
`• Ground 4: Claims 1-4 are obvious over Bason (Ex. 1007) in
`view of Allsop (Ex. 1006).
`
`Institution Decision (Paper 11) at 2
`
`Demonstrative Exhibit
`Not Evidence
`
`44
`
`3M Company Exhibit 1078
`Page 44 of 77
`
`
`
`’631 Patent: Claims 1 and 2
`
`’631 Patent (Ex. 1001) at 10:2-26
`
`Demonstrative Exhibit
`Not Evidence
`
`45
`
`3M Company Exhibit 1078
`Page 45 of 77
`
`
`
`’631 Patent: Claims 3 and 4
`
`’631 Patent (Ex. 1001) at 10:27-52
`
`Demonstrative Exhibit
`Not Evidence
`
`46
`
`3M Company Exhibit 1078
`Page 46 of 77
`
`
`
`’631 Ground 1 – Introduction
`
`Ground 1: Claims 1-4 are anticipated by Allsop (Ex. 1006).
`
`Issues in dispute
`
`• Push-button cap (“first member”)
`
`• “Displayable dose values”
`
`’631 Ground 1
`
`Demonstrative Exhibit
`Not Evidence
`
`47
`
`3M Company Exhibit 1078
`Page 47 of 77
`
`
`
`Ground 1: Allsop Anticipates Claims 1-4 of the ’631
`Patent
`
`Allsop discloses every element of claims 1-4
`
`Allsop (Ex. 1006)
`at 8:22-26
`
`Allsop (Ex. 1006)
`at 10:4-9
`
`’631 Ground 1
`
`Demonstrative Exhibit
`Not Evidence
`
`48
`
`’631 Petition (Paper 1) at 21-22
`
`3M Company Exhibit 1078
`Page 48 of 77
`
`
`
`Allsop Discloses and Enables a First Member:
`The “Push-Button Cap” That can Move Axially
`
`Allsop (Ex. 1006) at 8:22-26
`
`Mr. Piper:
`
`’631 Ground 1
`
`’631 Petition (Paper 1)
`at 36-37;
`’631 Reply (Paper 28) at
`1-3;
`Piper Decl. (Ex. 1002)
`at ¶¶ 62-63
`
`Demonstrative Exhibit
`Not Evidence
`
`49
`
`3M Company Exhibit 1078
`Page 49 of 77
`
`
`
`Allsop Discloses and Enables a First Member:
`The “Push-Button Cap” That can Move Axially
`
`Aptar argues: The sides of the cap would recess into the device between
`the inner and outer housing, which would either prevent the cap from
`moving, or interfere with the ring and pins.
`
`’631 Corrected Patent Owner
`Response (Paper 27) at 11-13
`
`Mr. Clemens:
`
`Mr. Piper:
`
`’631 Corrected Patent Owner
`Response (Paper 27) at 14
`
`’631 Ground 1
`
`’631 Petition (Paper 1)
`at 36-37;
`’631 Reply (Paper 28) at
`1-3;
`Piper Decl. (Ex. 1002)
`at ¶¶ 62-63
`
`Demonstrative Exhibit
`Not Evidence
`
`50
`
`3M Company Exhibit 1078
`Page 50 of 77
`
`
`
`Allsop Discloses and Enables a First Member:
`The “Push-Button Cap” That can Move Axially
`
`“[T]he push-button cap is located on the
`top rim of the outer housing where it
`‘cover[s] the upper portion of the
`pressurized dispensing container 15.’
`Allsop, Ex. 1006 at 8:22-26; Petition at
`37.”
`
`’631 Reply (Paper 28) at 2
`
`“[T]he sides of the push-button cap do
`not interfere with ring 160. Piper Decl.,
`Ex. 1058 ¶ 10. The top ‘push-button’
`portion of the cap moves axially.”
`
`’631 Reply (Paper 28) at 2
`
`’631 Ground 1
`
`Allsop (Ex. 1006) at 8:22-26.
`
`Mr. Piper:
`
`’631 Petition (Paper 1)
`at 36-37;
`’631 Reply (Paper 28) at
`1-3;
`Piper Decl. (Ex. 1002)
`at ¶¶ 62-63
`
`Demonstrative Exhibit
`Not Evidence
`
`51
`
`3M Company Exhibit 1078
`Page 51 of 77
`
`
`
`A First Member (Push-Button Cap) Engages the
`Second Member (Inner Housing) in Allsop
`
`The push-button would have
`engaged with the second
`member (the inner housing)
`either directly or indirectly.
`“Specifically, when the button is
`depressed, both the canister
`and inner housing move axially
`downward.”
`
`Piper Decl. (Ex. 1002) at ¶ 66;
`’631 Petition (Paper 1) at 38
`
`’631 Ground 1
`
`Allsop (Ex. 1006) at 8:22-26.
`
`Mr. Piper:
`
`’631 Petition (Paper 1)
`at 36-37;
`’631 Reply (Paper 28) at
`1-3;
`Piper Decl. (Ex. 1002)
`at ¶¶ 62-63
`
`Demonstrative Exhibit
`Not Evidence
`
`52
`
`3M Company Exhibit 1078
`Page 52 of 77
`
`
`
`Allsop Discloses Two Ways to Display and Change
`Dose Values
`1. A ring for indicating that the container contains one less dose:
`
`Allsop (Ex. 1006) at 9:13-17; see also ’631 Petition (Paper 1) at 34-35, 39-40
`
`2. A series of numbers spaced around the inner housing
`such that only a single number can be seen through
`the slots at any given time:
`
`Allsop (Ex. 1006) at 10:4-9 ; see also ’631 Petition (Paper 1) at 34-35, 39-40
`
`’631 Ground 1
`
`Demonstrative Exhibit
`Not Evidence
`
`53
`
`3M Company Exhibit 1078
`Page 53 of 77
`
`
`
`’631 Ground 2 – Introduction
`
`Ground 2: Claims 1-4 are anticipated by Marelli (Ex. 1008).
`
`Issue in dispute
`
`• “[A] second member that is displaceable axially and in
`rotation relative to said stationary body.”
`
`’631 Ground 2
`
`Demonstrative Exhibit
`Not Evidence
`
`54
`
`3M Company Exhibit 1078
`Page 54 of 77
`
`
`
`Ground 2: Marelli Anticipates Claims 1-4 of the ’631
`Patent
`
`’631 Petition
`(Paper 1) at 44, 49
`
`’631 Petition (Paper 1) at 46
`
`’631 Ground 2
`
`Demonstrative Exhibit
`Not Evidence
`
`55
`
`3M Company Exhibit 1078
`Page 55 of 77
`
`
`
`Marelli Anticipates Claims 1-4 of the ’631 Patent
`
`Issue in dispute: “[A] second member that is displaceable axially and in
`rotation relative to said stationary body.”
`
`’631 Petition (Paper 1) at 46
`
`’631 Ground 2
`
`Clemens Decl. (Ex. 2021) at ¶ 20
`
`Demonstrative Exhibit
`Not Evidence
`
`56
`
`3M Company Exhibit 1078
`Page 56 of 77
`
`
`
`’631 Ground 3 – Introduction
`
`• Bason discloses a fluid
`dispenser with a dose
`counter that converts axial
`motion to rotational motion
`
`’631 Petition (Paper 1) at 23
`
`• Rhoades teaches a small,
`plastic, inexpensive
`mechanism for converting
`linear to rotational motion
`’631 Petition (Paper 1) at 28
`
`’631 Petition (Paper 1) at 4
`
`’631 Ground 3
`
`Demonstrative Exhibit
`Not Evidence
`
`57
`
`3M Company Exhibit 1078
`Page 57 of 77
`
`
`
`Overview of Key Issues for Ground 3
`
`Ground 3: Claims 1-4 are obvious over Bason (Ex. 1007) in view of Rhoades (Ex. 1009).
`
`Issues in dispute
`
`• Motivation to combine
`
`• Bason cap (disclosure of a “first member that is displaceable axially relative to [a]
`stationary body”)
`
`• Bason gears (disclosure of “when said first member displaces axially . . . said
`second member is caused to be displaced axially and permitted to rotate . . . .”)
`
`• Rhoades is analogous art (covered in ’177 Patent; see supra slides 26-29)
`
`• Secondary considerations (covered in ’177 Patent; see supra slides 42-43)
`
`’631 Ground 3
`
`Demonstrative Exhibit
`Not Evidence
`
`58
`
`3M Company Exhibit 1078
`Page 58 of 77
`
`
`
`No Obviousness Rejections During Prosecution
`
`Aptar Amendment:
`
`Aptar Remarks:
`
`’631 Patent File History (Ex. 1005) at 83, 85
`
`’631 Ground 3
`
`Bason (Ex. 1007) at Fig. 1
`
`Demonstrative Exhibit
`Not Evidence
`
`59
`
`3M Company Exhibit 1078
`Page 59 of 77
`
`
`
`Motivation to Combine: The FDA Guidance
`Provided Explicit Motivation to Combine
`
`The FDA Guidance recommended all future MDIs to integrate dose
`counters:
`
`’631 Petition (Paper 1) at 52-53
`
`FDA Guidance
`
`2001 Draft Guidance (Ex. 1012) at 5; 2003 Final Guidance (Ex. 1013) at 6; ’631 Petition (Paper 1) at 19, 52-53
`
`2001 Draft Guidance (Ex. 1012) at 6; 2003 Final Guidance (Ex. 1013) at 6; ’631 Petition (Paper 1) at 19, 52-53
`
`’631 Ground 3
`
`Demonstrative Exhibit
`Not Evidence
`
`60
`
`3M Company Exhibit 1078
`Page 60 of 77
`
`
`
`Motivation to Combine: A POSA Would Have
`Looked to Existing Mechanisms to Improve Bason
`
`• A POSA would have understood the need to improve prior
`art like Bason to scale up production, maximizing
`efficiency and reliability
`
`’631 Petition (Paper 1) at 53-55;
`Piper Decl. (Ex. 1002) at ¶¶ 134, 135
`
`• Faced with the need to mass produce MDIs with
`integrated dose counters, A POSA would have looked to
`other simple, plastic, inexpensive, mass-produced
`mechanisms that convert linear to rotational motion such
`as the mechanical pen of Rhoades
`
`’631 Petition (Paper 1) at 53-56;
`Piper Decl. (Ex. 1002) at ¶¶ 134-138
`
`’631 Ground 3
`
`Demonstrative Exhibit
`Not Evidence
`
`61
`
`3M Company Exhibit 1078
`Page 61 of 77
`
`
`
`Motivation to Combine: A POSA Would Have
`Looked to Existing Mechanisms to Improve Bason
`
`• Mr. Piper looked to a pen mechanism when asked to build
`a dose counter in around 1998 (see supra slide 19)
`
`• Mr. Clemens agreed POSAs know of and rely on basic
`mechanisms of a pen (see supra slides 20, 21)
`
`• A POSA would have looked to a pen mechanism when
`designing a dose counter for an MDI (see supra slides
`22-25).
`
`’631 Ground 3
`
`Demonstrative Exhibit
`Not Evidence
`
`62
`
`3M Company Exhibit 1078
`Page 62 of 77
`
`
`
`Ground 3: A POSA Would Have Known How to
`Connec
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