UNITED STATES PATENT AND TRADEMARK OFFICE
`
`————————————————
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`————————————————
`
`MYLAN PHARMACEUTICALS INC.,
`Petitioner,
`
`v.
`
`SANOFI-AVENTIS DEUTSCHLAND GMBH,
`Patent Owner.
`
`————————————————
`Case IPR2019-01657
`Patent No. RE47,614
`————————————————
`
`MYLAN’S REPLY
`37 CFR §§42.23 & 42.24
`
`

`

`TABLE OF CONTENTS
`
`Page
`Introduction ...................................................................................................... 1
`
`Forfeitures and Waiver .................................................................................... 3
`
`I.
`
`II.
`
`A.
`B.
`C.
`
`Sanofi’s Arthrex Statement Preserves Nothing ..................................... 3
`Claims 2-8 and 10-17 Stand or Fall With Claim 1 ............................... 4
`Sanofi Has Forfeited Any Secondary Considerations
`Argument ............................................................................................... 4
`Sanofi Waives Narrower Means-Plus-Function
`Constructions ......................................................................................... 4
`III. Harms Just Implemented Burren’s Suggestions .............................................. 5
`
`D.
`
`IV. Claim Construction: Any Distinction Between Positioning and Fixing
`Is Unproven and Irrelevant .............................................................................. 8
`
`A.
`B.
`
`No Basis for a New Claim Construction ............................................... 8
`Harms Indicates “Fixing” Has a Broad Meaning
`Expressly Permitting Movement ........................................................... 9
`Harms Provides No Guidance on What an Acceptable
`Amount of Movement for “Fixing” Would Be ................................... 11
`Burren Teaches A Positioning Device Can Optionally Be
`a Fixing Device ................................................................................... 11
`Venezia and de Gennes Exemplify Burren’s Suggestions ............................ 13
`
`C.
`
`D.
`
`V.
`
`A.
`
`Venezia Shows Spring Washers Were Known in the Art ................... 13
`1.
`Venezia does not require bodily incorporation ......................... 13
`2.
`Obviousness does not require a deficiency ............................... 14
`3.
`Even considered improperly in isolation, Venezia
`suggests adequate axial and rotational fixing ........................... 14
`-ii-
`
`

`

`B.
`
`An additional tongue would have been obvious ....................... 16
`4.
`De Gennes Shows Axially-Extending Legs Were Known
`for Fixing a Spring Washer ................................................................. 17
`1.
`De Gennes does not require bodily incorporation into
`Burren: applying its teaching of a spring with fixing legs
`is sufficient ................................................................................ 17
`Claim 18: combination is as enabled as Harms ........................ 18
`2.
`De Gennes is analogous art ....................................................... 19
`3.
`No improper hindsight .............................................................. 21
`4.
`Sanofi’s Faulty Rationale Argument Misstates the
`Petition’s Rationale to Combine and the Law of
`Obviousness ......................................................................................... 23
`1.
`Burren properly provides the rationale ..................................... 23
`2.
`Selecting an appropriate spring was within ordinary skill ....... 24
`3.
`The petition’s rationale addresses challenged claim 9 ............. 24
`VI. Conclusion ..................................................................................................... 25
`
`C.
`
`-iii-
`
`

`

`TABLE OF CONTENTS
`
`Pages
`
`Cases
`Abbott Labs. v. Andrx Pharm., Inc., 452 F.3d 1331 (Fed. Cir. 2006) .....................22
`ArcelorMittal France v. AK Steel, 700 F.3d 1314 (Fed. Cir. 2012) ......................3, 4
`Arthrex, Inc. v. Smith & Nephew, 941 F.3d 1320 (Fed. Cir. 2019) ........................... 3
`HarzIn re Harza, 274 F.2d 669 (CCPA 1960) ................................................................16
`Hockerson-Halberstadt v. Avia Group Int’l, 222 F.3d 951 (Fed.
`Cir. 2000) ............................................................................................................15
`KSR Int'l v. Teleflex Inc., 550 U.S. 398 (2007) ................................................. 19, 21
`LeVeen v. Edwards, 57 USPQ2d 1406 (BPAI 2000) ................................................ 3
`McLaIn re McLaughlin, 443 F.2d 1392 (CCPA 1971) .............................................. 14, 22
`MontIn re Montgomery, 677 F.3d 1375 (Fed. Cir. 2012) .................................................. 5
`MoutIn re Mouttet, 686 F.3d 1322 (Fed. Cir. 2012) ............................................. 6, 13, 17
`Nat’l Steel Car, Ltd. v. Canadian Pac. Ry., Ltd., 357 F.3d 1319
`(Fed. Cir. 2004) ...................................................................................................25
`NilsIn re Nilssen, 851 F.2d 1401 (Fed. Cir. 1988) .................................................. 14, 22
`PaulIn re Paulsen, 30 F.3d 1475 (Fed. Cir. 1994) .................................................. passim
`Phillips v. AWH Corp., 415 F.3d 1303 (Fed. Cir. 2005) .........................................10
`Scientific Plastic Prods., Inc. v. Biotage AB, 766 F.3d 1355 (Fed.
`Cir. 2014) ............................................................................................................19
`SoviIn re Sovish, 769 F.2d 738 (Fed. Cir. 1985) ..................................................... 18, 24
`TexaIn re Trans Texas Holdings Corp., 498 F.3d 1290 (Fed. Cir. 2007) .......................10
`Transl In re Translogic Tech., Inc., 504 F.3d 1249 (Fed. Cir. 2007) .......................... 21, 23
`
`-iv-
`
`

`

`Transocean Offshore Deepwater Drilling v. Maersk Contractors
`USA, 617 F.3d 1296 (Fed. Cir. 2010) .......................................................... 13, 17
`Vanda Pharm. Inc. v. West-Ward Pharm. Int’l Ltd., 887 F.3d 1117
`(Fed. Cir. 2018) ..................................................................................................... 4
`Wyers v. Master Lock Co., 616 F.3d 1231 (Fed. Cir. 2010) ....................................19
`Rules
`37 CFR §42.6 ............................................................................................................. 3
`
`-v-
`
`

`

`I.
`
`INTRODUCTION
`
`Petitioner Mylan Pharmaceuticals Inc. (“Mylan”) seeks cancellation of
`
`claims 1-18 of U.S. Patent RE47,614 (“Harms”; EX1001). The response (POR,
`
`Paper 14) of the patent owner (“Sanofi”) and the accompanying declaration of
`
`Sanofi’s expert, Gordon Row (EX2001), fail to overcome the facial unpatentability
`
`showing in the petition, and Sanofi’s responsive materials and Mr. Row in his
`
`deposition (EX1036) admit key facts further confirming unpatentability.
`
`Sanofi does not squarely address the petition’s arguments and supporting
`
`declaration of Dr. Arthur Erdman (EX1004), and instead introduces strawman
`
`arguments to avoid confronting Mylan’s actual grounds of unpatentability. For
`
`example, Sanofi improperly converts the petition’s single ground into two grounds
`
`to treat the combination piecemeal. However, the sole ground was and remains the
`
`combined teachings of Burren (EX1006), Venezia (EX1007), and de Gennes
`
`(EX1008).
`
`Burren alone discloses an injector pen with a spring biasing a cartridge
`
`distally. Although Burren illustrates a coil spring, Burren expressly discloses using
`
`other spring types, including a plate spring, and further discloses that the spring
`
`used may have legs. EX1006, ¶16. Burren alone essentially anticipates the
`
`challenged claims; indeed, Mr. Row concedes the contested structures were well
`
`known to POSAs. EX1036, 58:4-62:12. Venezia shows—consistent with Burren’s
`
`-1-
`
`

`

`plate-spring suggestion—the known use of spring washers in the injector art for
`
`accommodating tolerances between separate components. Pet. 37; EX1007.
`
`Similarly, de Gennes discloses a spring washer with legs consistent with Burren’s
`
`teaching of springs with legs. Pet. 38; EX1008. Sanofi concedes that key claim
`
`terms are not means-plus-function limitations, further confirming unpatentability
`
`by expanding the scope of the claims to encompass structures that Sanofi concedes
`
`were well known to a person of ordinary skill in the art (“POSA”) at the time of
`
`filing.
`
`Sanofi’s attack on grounds it alone created is not the response’s only failure.
`
`For example, while Sanofi acknowledges that physical incorporation is not the sole
`
`test for obviousness (POR 49), Sanofi nevertheless argues against its strawman
`
`combinations by asserting the references cannot be physically combined. The
`
`petition’s reasons to combine and expectation of success, however, arise directly
`
`from Burren’s express suggestions, not from Sanofi’s reimagined grounds. Pet. 36-
`
`37. Moreover, Sanofi’s analysis of de Gennes’ analogousness relies on a faulty
`
`understanding of controlling law and mischaracterization of the petition’s use of de
`
`Gennes. Pet. 48.
`
`In sum, Sanofi’s response fails to address the ground presented in the
`
`petition on its merits—focusing instead on mischaracterization and misdirection—
`
`-2-
`
`

`

`meaning Sanofi has ultimately failed to meet its burden of production. Its surreply
`
`will be too late. The challenged claims are unpatentable and should be canceled.
`
`II.
`
`FORFEITURES AND WAIVER
`
`Argument not made in the response is forfeit. Paper 10 (Order), 8. Sanofi’s
`
`forfeitures and waiver have streamlined the issues for consideration. Mylan will
`
`focus only on the arguments Sanofi actually made.
`
`A. Sanofi’s Arthrex Statement Preserves Nothing
`
`Sanofi tried to preserve an Arthrex challenge but failed. POR 76. Argument
`
`cannot be incorporated by reference.1 37 CFR §42.6(a)(3). Moreover, passing
`
`reference does not preserve an argument. ArcelorMittal France v. AK Steel,
`
`700 F.3d 1314, 1325 n.6 (Fed. Cir. 2012). Sanofi’s reservation consists of
`
`references to another’s arguments regarding the Arthrex remedy in documents not
`
`of record. POR 76-77. Without conceding the correctness of any portion of
`
`Sanofi’s Arthrex statement, Mylan notes that Sanofi provided no actual argument
`
`requiring response. Consequently, whatever its intention, Sanofi did not preserve
`
`this argument.
`
`1 The POR is close to the word limit. See LeVeen v. Edwards, 57 USPQ2d 1406,
`
`1412 (BPAI 2000) (incorporation is self-help brief-limit evasion).
`
`-3-
`
`

`

`B. Claims 2-8 and 10-17 Stand or Fall With Claim 1
`
`Claims not argued separately stand or fall together. Vanda Pharm. Inc. v.
`
`West-Ward Pharm. Int’l Ltd., 887 F.3d 1117, 1134 n.9 (Fed. Cir. 2018). Sanofi
`
`addresses only claims 1, 9, and 16-18. Moreover, for claims 10, 16, and 17 Sanofi
`
`simply quotes their respective limitations, which is not separate argument. Cf.
`
`ArcelorMittal, supra. Claims 2-8 and 10-17 stand or fall with claim 1. See POR 17
`
`n.1 (addressing claim 17 with claim 1).
`
`C. Sanofi Has Forfeited Any Secondary Considerations Argument
`
`Sanofi does not assert any secondary consideration indicating non-
`
`obviousness, such as unexpected results or commercial success. Sanofi has
`
`forfeited any secondary considerations argument.
`
`D. Sanofi Waives Narrower Means-Plus-Function Constructions
`
`Sanofi’s claim construction does not affect the claims’ patentability. First,
`
`Sanofi addresses only two claim terms: “cartridge retaining member” and “fixing
`
`elements”, contending both terms are not subject to a means-plus-function
`
`reading.2 POR 6-10. Indeed, Sanofi admits both terms describe classes of
`
`2 Sanofi’s asserted distinction between “positioning” and “fixing” is addressed in
`
`§IV, below.
`
`-4-
`
`

`

`structures already known to a POSA. POR 7; EX2011, ¶¶34-35; EX1036, 58:4-
`
`62:12. Because Sanofi has waived any argument applying a narrower means-plus-
`
`function reading (Paper 10, 8), the Board need not resolve this issue because the
`
`petition applied the same ground to both the narrower and broader constructions.
`
`Pet. 12. Hence, the claims’ patentability does not depend on these terms’
`
`constructions. In re Montgomery, 677 F.3d 1375, 1381 (Fed. Cir. 2012)
`
`(construction not necessary where claims unpatentable under either alternative).
`
`III. HARMS JUST IMPLEMENTED BURREN’S SUGGESTIONS
`
`Sanofi summarizes the novelty of the Harms invention as “attaching the spring
`
`washer with fixing elements to a sleeve inserted in the housing.” POR 2. Setting aside
`
`the lack of a sleeve limitation in most of the challenged claims, Burren anticipated this
`
`purported novelty:
`
`A spring in accordance with the present invention may be a tension
`spring, flexion spring or torsion spring and, in some preferred
`embodiments, a compression spring. Its shape may be that of a coil
`spring, leaf spring, plate spring, a spring with legs, for example, or any
`suitable configuration. In many applications or uses it may be provided
`in the form of a coil spring.
`
`EX1006, ¶16; see also id., ¶17 (“the spring may serve as a means of compensating
`
`longitudinal tolerances for supporting a medicament container in an injection device,
`
`such as an injection pen”). As the petition explained—and Sanofi does not contest—
`
`-5-
`
`

`

`”a POSA would have understood a spring washer to be a type of plate spring.”
`
`Pet. 40, citing EX1004, ¶125. Hence, Burren already taught or suggested exactly what
`
`Sanofi now contends was novel. Venezia and de Gennes were cited simply as
`
`examples within classes of structures that Sanofi and its expert insist were known to a
`
`POSA anyway.3 POR 7; EX2001, ¶¶34-35; EX1036, 58:11-62:12; see also
`
`EX1038, ¶14. Burren also taught the sleeve. Pet. 54-55; EX1004, ¶155-56;
`
`EX1006, ¶¶14, 23, 33, FIG. 4.
`
`Sanofi notes that Burren expresses a preference for a plastic spring. POR 10.
`
`However, a reference is good for all it fairly teaches, and Burren certainly does not
`
`teach away because it acknowledges that metal springs were a norm in the prior art.
`
`EX1006, ¶4; see also EX1004, ¶98 (addressing plastic and metal springs). Cf. In re
`
`Mouttet, 686 F.3d 1322, 1334 (Fed. Cir. 2012) (better alternative is not a teaching
`
`away). Anyway, Sanofi’s claims do not require a metal spring, which was a known
`
`3 The ground of unpatentability was and remains obviousness over a combination
`
`of references. To the extent Sanofi’s claim construction concedes the elements
`
`Burren suggests were already well-known for the suggested purposes, Burren may
`
`now verge on an anticipation, which is the ultimate of obviousness. In re Paulsen,
`
`30 F.3d 1475, 1481 (Fed. Cir. 1994).
`
`-6-
`
`

`

`option along with plastic. EX1001, 6:61 (“The spring washer may contain metal or
`
`may be of metal.”); EX1036, 21:20-25 (plastic spring washer in injector pen).
`
`Sanofi also argues that Burren’s second embodiment lacks a spring within
`
`the housing and thus purportedly lacks an element of each of the independent
`
`claims. POR 16-17. Sanofi’s argument implicitly concedes that Burren’s first
`
`embodiment teaches this feature. Moreover, Sanofi is wrong. Mr. Row’s selective
`
`coloring of the annotated detail of Burren Figure 4 is telling. A portion of the
`
`spring 20 is colored green, while the housing 3 is colored purple. POR 18. In this
`
`annotation, none of the spring appears to be within the housing. Yet by simply
`
`inspecting the figure, one sees the figure’s cross-hatching requires the spring to be
`
`a continuous piece with positioning device 23 and retaining mechanism 23b.
`
`EX1006, ¶33; cf. id., ¶16 (“spring with legs”), claims 19-20 (spring with retaining
`
`mechanism by which it is retained on another component). Retaining
`
`mechanism 23b indisputably “latches in the recess of the housing portion 3.” Mr.
`
`Row reluctantly conceded as much in his deposition. EX1036, 62:18-67:25. Dr.
`
`Erdman confirms the legs of the spring in Burren’s second embodiment are in fact
`
`within the housing. EX1038, ¶¶15-16 (citing EX1006, ¶¶32-33, FIG. 4). Sanofi has
`
`not identified claim language requiring the entire spring to be located within the
`
`housing. Hence, Burren’s second embodiment (without the misleading annotation
`
`-7-
`
`

`

`but read in context with the disclosure) shows a spring partially within and latched
`
`to the housing. Id.
`
`IV. CLAIM CONSTRUCTION: ANY DISTINCTION BETWEEN
`POSITIONING AND FIXING IS UNPROVEN AND IRRELEVANT
`
`According to Sanofi, the Harms patent distinguishes between “positioning
`
`element” and “fixing element”. POR 8. Relying on claim differentiation, Sanofi
`
`notes “positioning element” is recited in dependent claim 10, and argues “fixing
`
`element” must thus have a narrower meaning of “securing by attachment”. POR 8-
`
`9. However, the Harms specification neither provides express definitions nor
`
`otherwise distinguishes the terms the way Sanofi suggests. Even if a distinction
`
`existed, the prior art shows positioning elements that securely attach within the
`
`meaning of the Harms patent.
`
`A. No Basis for a New Claim Construction
`
`“Although an inventor is indeed free to define the specific terms used to
`
`describe his or her invention, this must be done with reasonable clarity,
`
`deliberateness, and precision.” In re Paulsen, 30 F.3d 1475, 1480 (Fed. Cir. 1994).
`
`In Paulsen, the inventor tried to distinguish prior art by urging the term
`
`“computer” in the claims required a full-function computer and not a limited-
`
`function computer like the calculator disclosed in the reference. The court,
`
`however, noted the inventor never provided that definition, and explained “the
`
`specification merely describes in a general fashion certain features and capabilities
`-8-
`
`

`

`desirable in a portable computer[, which] is far from establishing a specialized
`
`definition restricting the claimed invention....” Id. Here, Harms provides no
`
`express definition of these contested terms, and the Harms disclosure undermines
`
`Mr. Row’s testimony asserting a narrower meaning for “fixing”.
`
`B. Harms Indicates “Fixing” Has a Broad Meaning Expressly
`Permitting Movement
`
`Sanofi points to disclosure saying the fixing element secures against axial or
`
`rotation movement. POR 8-9. In full, the passage says:
`
`Spring washer 50 may be fixed to sleeve member 60 by a snap-fit, for
`example. Sleeve member 60 and/or spring washer 50 is expediently
`secured against rotational and/or axial movement with respect to the
`housing.
`
`EX1001, 5:34-38. While this passage provides an example with an expedient
`
`option, it is not a definition. EX1038, ¶11; Paulsen, 30 F.3d at 1480 (listed
`
`possibilities not a definition). Similarly, Sanofi points to a passage it says defines
`
`“positioning element” as “keeping the spring washer 50 in a determined
`
`orientation.” POR 8, citing EX1001, 5:45-47. Again, the full passage falls short of
`
`a definition:
`
`The spring washer 50 may be provided with one, or a plurality of
`positioning elements. The respective positioning 45 element may serve
`for keeping the spring washer 50 in a determined orientation, preferably
`in a predetermined angular orientation, with respect to the housing 10.
`
`-9-
`
`

`

`For example, the fixing elements 52 may serve as positioning elements.
`The respective positioning element may cooperate with the 50 housing or
`an element axially and rotationally locked to the housing for keeping the
`spring washer 50 in the predetermined orientation.
`
`The passage is an example listing preferences and nothing more. EX1038, ¶11;
`
`Paulsen, 30 F.3d at 1480. Mr. Row’s contrary testimony and general dictionaries
`
`are extrinsic evidence that cannot contravene what the specification states. Phillips
`
`v. AWH Corp., 415 F.3d 1303, 1318 (Fed. Cir. 2005). Even if the dictionary
`
`definitions were considered, they provide examples of “fixing” again falling short
`
`of meaning “securing by attachment”. EX2004, 3 (“to make or become firm,
`
`stable, or secure”, “to attach or place permanently”) (emphasis added); EX2006, 3
`
`(same). Sanofi cannot highlight only the definitions it likes and ignore the rest; all
`
`definitions consistent with the intrinsic evidence are correct. In re Trans Texas
`
`Holdings Corp., 498 F.3d 1290, 1299 (Fed. Cir. 2007).
`
`Sanofi also points to challenged claim 10 for support. POR 9. Claim 10
`
`includes the phrase “wherein the at least two fixing elements are further configured
`
`as positioning elements, which keep the spring washer in a determined
`
`orientation.” EX1001, 8:44-46. This phrase simply reflects Harms’ disclosure that
`
`fixing elements may be positioning elements, and that positioning elements may
`
`determine orientation. EX1001, 5:48-53. Claim 10’s language provides no further
`
`definition of whether and how fixing elements accomplish their fixing function.
`
`-10-
`
`

`

`C. Harms Provides No Guidance on What an Acceptable Amount
`of Movement for “Fixing” Would Be
`
`The core problem for Sanofi’s argument is that, in Harms, “fixing” permits
`
`some movement. Harms provides no guidance on how much movement is
`
`permitted before “fixing” ceases to be “fixing”. Harms expressly permits axial
`
`movement of the fixing elements during spring loading. EX1001, 5:38-40. Harms
`
`further provides that guide slots preferably restrict axial movement of the spring
`
`washer, and “may rotationally lock” the spring washer with respect to the housing.
`
`EX1001, 5:62-67. Hence, Harms provides options and preferences about whether
`
`the fixing element can move, but nothing that intrinsically requires “fixing” to bar
`
`any movement at all in all directions. EX1038, ¶12 (citing EX1001, 5:54-67); see
`
`also EX1004, ¶97. The distinction Sanofi tries to draw between positioning and
`
`fixing is ambiguous at best because Harms provides no guidance regarding when a
`
`positioning element permits so much movement that it fails to be a fixing element.
`
`EX1038, ¶12. Instead, Harms treats positioning elements and fixing elements as
`
`broadly overlapping classes of structures. Id. This broad overlap is significant to
`
`the discussion below regarding Venezia’s teaching of a fixing element. §V.A.3.
`
`D. Burren Teaches A Positioning Device Can Optionally Be a
`Fixing Device
`
`Even if Sanofi’s distinction between fixing and positioning elements were
`
`correct and relevant, the ground I references teach a positioning device that
`
`-11-
`
`

`

`preferably attaches to one component and moves in tandem with another
`
`component, i.e., securely attaches or fixes the spring to a housing component.
`
`EX1038, ¶13. Specifically, Burren explains that a positioning device may be
`
`formed as part of the spring. EX1006, ¶13. Burren further explains that the
`
`positioning device can perform a retaining function to one of the components
`
`between which it acts or to an intervening component that locks the movement of
`
`the spring with respect to the first component:
`
`The positioning device may be designed to assume more than just a pure
`supporting function, i.e. supporting the spring force, and can be improved
`to form a retaining mechanism, by which the spring is retained on one of
`the components between which the spring acts or on another component
`of the device. If the spring is retained on a third component, the function
`of the spring must not be detrimentally affected as a result, i.e. if retained
`in this manner, the spring will either be supported on a third component
`which moves jointly with one of the two other components or, although
`the spring is retained on the third component, it is displaceable relative to
`the third component. The means for retaining the spring may be a catch
`connection in particular, in which case the positioning device forms one
`of the catch elements for the catch connection to be produced or is
`formed in the already existing catch connection.
`
`EX1006, ¶14; EX1038, ¶13. Thus, even if there were an alleged distinction in
`
`Harms between a positioning element and a fixing element, it does not matter
`
`because Burren also describes a positioning element that is a fixing element. Id.
`
`-12-
`
`

`

`Specifically, Burren teaches a positioning device fixes the spring relative to the
`
`housing, including via a sleeve. Pet. 54-55; EX1038, ¶13.
`
`V.
`
`VENEZIA AND DE GENNES EXEMPLIFY BURREN’S
`SUGGESTIONS
`
`A. Venezia Shows Spring Washers Were Known in the Art
`
`1. Venezia does not require bodily incorporation
`
`Following Burren’s suggestion to use springs (like a plate spring) other than
`
`a coil spring or spring bellows, the petition cited Venezia to establish spring
`
`washers were known in the art to prevent undesired axial movement between two
`
`components. Pet. 21. Sanofi notes differences between Venezia’s syringe and the
`
`claimed invention (POR 11-13), which misses the point. Venezia was not offered
`
`as part of some complex modification to Burren; rather, Venezia shows familiarity
`
`in the art with using a spring washer for the purpose Burren suggests: axial biasing
`
`to secure two components against relative movement. See EX1038, ¶25. This is an
`
`elementary concept and a POSA would understand that incorporating Venezia’s
`
`exact spring washer was not necessary. Id. Instead a POSA would adopt only those
`
`portions providing the functions Burren suggested—a spring to bias the cartridge
`
`and optionally legs. Transocean Offshore Deepwater Drilling v. Maersk
`
`Contractors USA, 617 F.3d 1296, 1304 (Fed. Cir. 2010) (requiring bodily
`
`incorporation would reduce the POSA to a mere automaton); Mouttet, 686 F.3d
`
`at 1332; see also EX1038, ¶25.
`
`-13-
`
`

`

`2. Obviousness does not require a deficiency
`
`Sanofi also argues that the petition fails to identify any deficiency in
`
`Venezia’s washer that requires correction, which inverts the actual ground.
`
`POR 18-19. The petition instead notes Burren’s express suggestion to use different
`
`springs and turns to Venezia to exemplify an alternative spring. See EX1038, ¶35
`
`(noting analogous function of Venezia’s spring washer relative to Burren’s
`
`teachings). Sanofi does not and cannot point to any authority requiring Venezia to
`
`be deficient before it can supply a specific example for a general suggestion. In re
`
`Nilssen, 851 F.2d 1401, 1403-04 (Fed. Cir. 1988) (sufficiency of the prior art not
`
`the test).
`
`3. Even considered improperly in isolation, Venezia suggests
`adequate axial and rotational fixing
`
`Venezia suggests fixing a spring washer both axially and rotationally.
`
`Although Sanofi argues Venezia’s fixing is inadequate, Sanofi fails to identify
`
`claim limitations specifying when and to what degree the fixing must occur.
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`POR 49-58. Moreover, Sanofi’s argument tellingly ignores the third reference in
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`the combination (de Gennes), which provides unequivocal hooks on axial legs 34
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`designed to latch onto another structure. In re McLaughlin, 443 F.2d 1392, 1395
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`(CCPA 1971) (references must be considered as a whole for all that they teach). As
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`the institution decision noted (at 25), Venezia suggests a tongue and slot
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`arrangement that could be adapted to Burren’s pen. See also EX1038, ¶26.
`-14-
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`

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`Correspondingly, Burren teaches that a retaining mechanism 23b can latch on the
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`housing 3. EX1006, ¶33; see also EX1038, ¶28.
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`Sanofi applies a bodily-incorporation approach that improperly relies
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`heavily on drawing dimensions. See Hockerson-Halberstadt v. Avia Group Int’l,
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`222 F.3d 951, 957 (Fed. Cir. 2000) (improper to use drawing to infer relative sizes
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`of grooves and fins absent support in specification). Even if it were proper to use
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`the drawings to try to prove movement that Venezia itself does not even mention,
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`Sanofi’s argument assumes bodily incorporation rather than modification to
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`produce a slot-fit connection directly or indirectly with the housing as the petition
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`explained. Decision 25, citing Pet. 47; see also EX1038, ¶¶27-28; EX1004, ¶97
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`(noting POSA would have readily adapted spring by, e.g., repositioning tongues).
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`Moreover, even if Venezia’s tongue permits some movement during assembly, the
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`claims (1) do not require that the fixing elements are the sole element involved in
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`fixing the spring in place, (2) do not require that the spring must be fixed during
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`assembly, and (3) do not specify the degree of movement permitted before the
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`spring is no longer considered fixed. See §IV.C; EX1038, ¶27. Venezia’s tongue
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`provides substantial rotational fixing and axial fixing in at least one direction even
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`before the syringe is entirely assembled, and continues to contribute to axial fixing
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`after assembly. EX1038, ¶¶26-28. Harms’ claims require no more.
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`-15-
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`

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`4. An additional tongue would have been obvious
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`“It is well settled that the mere duplication of parts has no patentable
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`significance unless a new and unexpected result is produced”. In re Harza,
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`274 F.2d 669, 671 (CCPA 1960). The petition explained that a second tongue
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`would prevent tilting, citing expert testimony. Pet. 48, 65. Sanofi relies on its
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`expert, who disagrees but provides no new and unexpected result that would arise
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`from duplicating the fixing elements. Common sense supports the idea that a
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`second fixing element will provide greater fixing. EX1038, ¶29; cf. Harza,
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`274 F.2d at 671 (multiplying ribs for better retention). Sanofi has failed to meet its
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`burden of production to rebut this elementary concept. See EX1038, ¶¶30-31
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`(explaining concept of even-load support and advantage to second tongue in
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`further constraining spring washer from tilting).
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`Sanofi also contends (POR 73-75) that because Venezia would still permit
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`some movement, it would still permit some wear. Sanofi fails to show, however,
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`that limiting movement would not limit wear, as a POSA would expect. See
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`EX1038, ¶37.
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`-16-
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`

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`B. De Gennes Shows Axially-Extending Legs Were Known for
`Fixing a Spring Washer
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`1. De Gennes does not require bodily incorporation into Burren:
`applying its teaching of a spring with fixing legs is sufficient
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`Following Burren’s suggestion to use springs with legs, the petition cited de
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`Gennes for a spring washer with axially extending legs having cutouts that snap-fit
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`onto another piece to provide axial and rotational fixing. Pet. 23. Sanofi makes
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`much of de Gennes’ describing an automotive clutch, which again misses the
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`salient point. A POSA is not an automaton and would readily understand that the
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`specific clutch cover would not be lifted intact from de Gennes and substituted into
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`Burren’s pen. De Gennes was not used to suggest bodily incorporation into Burren;
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`rather, it was used as an answer to Burren’s suggestion of providing a spring with
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`legs. See EX1038, ¶17. A POSA could be trusted to know how to adapt the simple
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`teaching of a spring with legs to an injector pen. Id.; Mouttet, 686 F.3d at 1332;
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`Transocean, 617 F.3d at 1304.
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`Sanofi argues that de Gennes is not “a suitable replacement” for Burren’s
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`coil spring because Burren biases components away while de Gennes biases
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`components together. POR 37. When asked whether a POSA would have known to
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`form the spring washer with legs such that the resilient portions (support zones)
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`provided force in the desired direction, Sanofi’s expert could not understand the
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`question, contradicted his own testimony, and ultimately purported to be unable to
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`-17-
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`

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`answer the question. EX1036, 76:1-84:16. Dr. Erdman, however, confirms that
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`forming the spring washer to exert force in the desired direction is an elementary
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`design concept. EX1038, ¶¶20-21 (noting similarities in spring functions). Burren
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`plainly teaches that the spring biases the container distally, which would be ample
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`guidance to one with actual skill. Id.; EX1006, ¶¶3, 13, 23. Sanofi has taken its
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`bodily incorporation argument to the extreme of arguing that de Gennes is
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`irrelevant because a POSA would not know to form the spring washer to provide
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`biasing in the right direction. In re Sovish, 769 F.2d 738, 742-43 (Fed. Cir. 1985)
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`(ordinary skill must be presumed).
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`2. Claim 18: combination is as enabled as Harms
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`Similarly, for claim 18, Sanofi argues that de Gennes’ fixing elements would
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`not “allow axial loading of the spring washer when the cartridge retaining member
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`is secured to the housing” as the claim requires. POR 47. As an initial matter,
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`Harms does not provide any detail on how the fixing elements allow axial loading
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`of the spring washer either, other than to note that axial movement is allowed.
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`EX1001, 5:38-40; EX1038, ¶23 (explaining how axial loading occurs; citing
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`EX1004, ¶¶91, 124, 144, EX1006, ¶13); Paulsen, 30 F.3d at 1481 n.9 (noting the
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`specification would not be enabling if held