Free Letter - District Court of Delaware - Delaware

Case 1:05-cv-00029-JJF Document 81 Filed O9/30/2005 Page 1 of 3
Ric:r~iAi=2i:>s, Lavroixr 6. FINGER
A PFlOFE.55!ONAL ASEOCEATEON
ONE RCJDNEY SQUARE
920 Noam Kino Srnstzr
{_-,,E¤ER,CK L COWRELL H, Wacmimorow, Damwmit: ioaon D*¤E¤T @***1- NUMBER
Donecron i (302) 651-77OCJ 302-55 E-7509
M (aaai assi-77*01 °°““m@"*“ "°°"‘
WWWrF?LF.COM
September 30, 2005
VIA E-FILING
The I·ionorable Joseph J Farnan, ir
United States District Court
District of Delaware
844 King Street
Wilmington, DE 19801
Re: Ceplmlon Inc., et al v. Barr I,abm·at0ries
C.A. 05-0029-JJF
Dear Judge Farnan:
1 write pursuant to Local Rule 7 l 2(c) to address Barr’s letter to the Court dated
September 23, 2005 concerning the Federal Circuit’s recent decision in Nystrorn v. Trex Co.,
@3,, No 034092, 2005 WL 2218632 (Fed Cir. Sept 14, 2005)
The Nystrom decision is readily distinguishable iiom this case. As Barr states, one of the
issues the Federal Circuit was considering in Nystrom was whether a claim term to a "board"
was limited to wood cut from a log The Federal Circuit decided that this was so, based
priniariiy on the use of the word "board" in the written description of the patent in suit. There,
the usage of the word "board" occurred exclusively in the context of wood fiooring materials
The patent stated that “the process used to cut such lumber from logs can produce inferior
product on the outermost boards, often leading to scrap " Nystrom, 2005 WT, 2.2i8632 at *5
(quoting patent in suit ) The Federal Circuit also found that "throughout the written description,
Nystroni consistently used the term “board’ to describe wood decking material cut from a log "
Q at *6. Similarly, in the prosecution history, the word "board" was used consistently to “refer
to wood decking materials cut from a iog " _l_g_:l
This case is dii`t`erent Here, the inventors did not use the word “mixing" exclusively to
refer to dry mixing, or mixing in the absence of free liquid As noted in Cephalon’s Markman
papers and at argument, the specification unequivocaily shows that the word “mixing," without
further limitation, simply means "eombining or biending " Indeed, the inventors used the word
“1nixed" and "mixture" to refer to the combining or blending of molten ingredients, which are
liquid:
in the manufacture of medicated candy products by existing methods, the
therapeutic agent is added to a molten candy mass The resultant mixture is then
thoroughly mixed to ensure proper distribution of the drug within the molten
1i1-rr-29201124

Case 1 :05-cv-00029-JJF Document 81 Filed O9/30/2005 Page 2 of 3
The llonorable Joseph J Farnan, Jr
September 30, 2005
Page 2
candy mass. The mixture is then poured while still molten and allowed to
solidify into a semi-solid mass (*737 Patent, Teran Decl Ex l, Col .3.56-62,
emphasis added; see generally Cephalon’s Reply Br on Claim Constr at 1 l )
Likewise, in the prosecution history, the inventors used the word "rnix" in a manner
which included the mixing ofliquid components:
For example, relatively insoluble components can be combined without the
difficulty of attempting to dissolve and mix those components, thereby resulting
in a composition in which the drug is delivered to the mucosal tissues for
absorption therethrough (Amendment, Oct 2.7, l988, Teran Decl Ex 3, at E2,
emphasis added )
Without question, in the prosecution history the inventors excluded molten methods,
which involve a particular ripe of liquid mixing They did so by explicit amendment to their
claims, requiring the mixing to occur below the melting points of the drug and carbohydrate But
in so doing, the inventors never redefined the word "mixing" to mean something other than
"cornhining or intending " And they never stated that they disclaimed wry form of mixing where
any so—called "free liquid" was present
Nystrom confirms the principles of Vitronics Corp. v. Conceptronic, Inc., 90 F 3d 1576,
E582 (Fed. Cir. l996) and Phillips v. AWH Corp., 415 F 3d 1303 (2005) (en banc), that words of
the claim are generally given their ordinary and customary meaning as understood by a person of
ordinary skill in the art in light ofthe entire intrinsic record. Nystrom, 2005 Wl. 2218632 at *4.
Cephalon is not attempting to expand the definition of "rnixing," but is giving it its ordinary and
customary meaning as would be understood by the skilled artisan. As set forth srrpra, the
specification and prosecution history use the words "mixing” to indicate that components are
being "combined or blended" irrespective of whether they are dry or in liquid (e g, molten)
form. This is the construction proposed by Cephalon
Furtherrnore, in the Nystrom Patent, the "board" of the invention is specifically described
as being one which is "cut from a log” or "obtained from a log " See, eg., U S Patent No.
5,474,831, Col 2:22~23 and 2:34 (attached hereto) This is not analogous to the instant case
"Mixing” is never defined in either the specification or prosecution history of the ‘737 Patent as
being "absent the presence of free liquid" or "without the use of free liquids " ln fact, the words
"f`ree liquid(s)" never even appear in either the specification or prosecution history ofthe "737
Patent Barr’s proposed construction thus is not one that "stays true to the claim language and
most naturally aligns with the patent’s description of the invention " Nystrom, 2005 Wl.,
2218632 at ***4 (quoting Phillips, 415 F 3d at 1316)
This case is far more like Phillips than Nystrom ln Phillips, initially a divided Federal
Circuit panel held, 2-1, that the claim term "baffles" should be construed to exclude any
structures that extend at a 90" angle from a wall, based on "repeated" references in the
specification to baffles that could deflect projectiles and the absence of a disclosure in the
specification of a baffle projecting from a wail at a right angle Phillips, 4l5 F 3d at l31O But
attr-2t¤2¤r1s.r

Case 1 :05-cv-00029-JJF Document 81 Filed O9/30/2005 Page 3 of 3
The l~lonorabie Joseph J Farnan, lr
September 30, 2005
Page 3
the en banc Federal Circuit reversed, and held that although the specification referred at several
points to an advantage ofthe baffles as described in the invention —— namely, the deflection of
projectiies — those statements did not restrict the claim term "baffies" only to those baffles that
served this advantage. Although "the invention envisions baffles that serve that function, it does
not imply that in order to qualify as baffles within the meaning ofthe claims, the internal support
structures must serve the pro_jectile~detlecting function in all the embodiments of all the claims "
gl at l325
Liltewise, although the invention of the ‘737 Patent clearly envisions mixing dry powders
as an advantageous embodiment, it does not imply that in order to qualify as "mixing°’ within the
meaning of the claims, no free liquid may be present So long as the process of mixing is not
molten, because additional claim language requires that the mixing be conducted at a
temperature below the melting points of the drug and the carbohydrate, the claim limitation
“mixing" is satistied
Respectfully,
WWK {aw if
Frederick L Cottrell, lll
FLC,IlI/afg
Attachment
cc: Clerk of the Court (via hand delivery and e—liling)
David B Bassett, Esquire (via e—mail)
Josy W Ingersoll, Esquire (via e—mail and e—filing)
George C Lombardi, Esquire (via email)
Bradley C Graveline, Esquire (via e-mail)
RLF1·2929ll3—l