United States District Court, D. Delaware
ORDER CONSTRUING THE TERMS OF U.S. PATENT NOS. 9,
155, 775 ("THE '775 PATENT") AND 9, 763, 993
("THE '993 PATENT"). 
considering the submissions of the parties and hearing oral
argument on the matter, IT IS HEREBY ORDERED, ADJUDGED, and
DECREED that, as used in the asserted claims of U.S. Patent
Nos. 9, 155, 775 ("the '775 Patent") and 9,
763, 993 ("the '993 Patent"):
1. The term "controlled room
temperature" in the '775 patent is
construed to mean "includes at least the range of
greater than or equal to 17.8° C to less than or equal to
2. The term "filtering the aqueous
pharmaceutical solution at a temperature of above 0° C to
17.5° C to produce a filtrate" in the
'775 patent and the terms "(iii) filtering
the first filtrate at a temperature of above 0° C. to
17.5° C. through a second filter to produce a second
filtrate" and "(ii) filtering the
aqueous pharmaceutical solution at a temperature of above
0° C. to 17.5° C. to produce a
filtrate" in the '933 patent are construed
to mean "filtering the aqueous pharmaceutical solution,
wherein the temperature of the aqueous pharmaceutical
solution is between 0° C and 17.5° C, inclusive of
3. The term "wherein the
filterability of the aqueous pharmaceutical solution is
improved as compared to the filterability of the solution at
controlled room temperature" in the '775
patent is construed to mean "wherein the filterability
of the aqueous pharmaceutical solution is improved as
compared to the filterability of the solution if the solution
were at controlled room temperature, as measured by,
e.g., a lower increase in pressure on the
 All docket citations refer to Civil
Action NO. 16- 1267-GMS. The abbreviation "Tr."
refers to the transcript from the Markman Hearing on November
2, 2017, D.I. 157.
The parties' dispute centers on
whether the person having ordinary skill in the art
("POSA") would know to consult the United States
Pharmacopeia ("USP"), which is extrinsic to the
patent, to determine the appropriate temperature during
filtration. Markman Hr'g Tr. 36:3-4. The court adopts
Defendants' construction of the term because its
construction comports with the description of the term in the
asserted patent and the intrinsic evidence. Phillips v.
AWH Corp., 415 F.3d 1303, 1317, 1320-21 (Fed. Cir. 2005)
(explaining that extrinsic evidence is "less significant
than the intrinsic record in determining the legally
operative meaning of claim language.'") (citing
C.R. Bard, Inc. v. U.S. Surgical Corp., 388 F.3d
858, 862 (Fed. Cir. 2004)).
Plaintiffs' proposed construction relies solely on
evidence extrinsic to the patent, namely the USP. First,
Plaintiffs argue that "controlled room temperature"
should have its plain and ordinary meaning as found in the
USP. (D.I. 118 at 4.) To support this position, Plaintiffs
argue that the USP-NF guidelines state that "controlled
room temperature" means "[t]he temperature
maintained at the usual and customary working environment of
20° to 25° (68° to 77° F)." (D.I. 118 at
Ex. A.) Plaintiffs, argue that the Federal Food, Drug, and
Cosmetic Act'("FDCA") tells the skilled artisan
that the USP is where to look for the definition of
"controlled room temperature" and that Abbott
Labs. v. Lupin Ltd., shows the USP decides the issue.
(D.I. 118 at Ex. A); Markman Hr'g Tr. 37:21-25, 38:1-8,
11:20-25, 27:14-25; Abbott Labs. v. Lupin Ltd., 753
F.Supp.2d 382, 418 (D. Del. 2010). Second, Plaintiffs argue
that "controlled room temperature" has a specific
definition because when the patent recites a temperature
other than a controlled room temperature, it provides a
numerical range. Markman Hr'g Tr. 16:11-14. Plaintiffs
argue that it is a misreading of the range from Table 2 to
include 17.8° to 24.6° C because the proper reading
is the plain and ordinary meaning, in accordance with the
USP, at 20°to 25° C. Markman Hr'g Tr. 17:8-24.
Defendants cite to various pharmacopeias, including Europe
and Japan, to show that the definition of "controlled
room temperature" is not uniform. (D.I. 125-1, Ex. 5 at
2); Markman Hr'g Tr. 30:20-23.
The court agrees with Defendants for three main
reasons. First, the provision of the USP that Plaintiffs cite
defines controlled room temperature in terms of storage and
shipping conditions, not the temperature at which the
solution is filtered. (D.I. 118, Ex. A at 317.) Indeed, the
FDCA tells the POSA to refer to the USP-NF only where no
storage requirements for a prescription drug are established.
21 C.F.R. § 205.50(c)(1). Second, the specification
shows the controlled room temperature to include 17.8° to
24.6° C. '775 Patent at 11:35-65. The specification,
therefore, explains that an improved filtration process was
necessary to avoid the pressure buildup on the second filter.
'775 Patent at 10:5-15; (D.I. 128 at ¶ 23,
11:45-58.) Also, Table 2 for Experiment Number 1 identifies
17.8° to 24.6° C as the temperature of the solution
held in the receiving vessel for the controlled room
temperature at 13 hours. '775 Patent at 11:35-65. The
range in Table 2 is the only place in the specification that
indicates the temperatures encompassed by the control room
temperature. Markman Hr'g Tr. 23:22-25. The court remains
unconvinced that a POSA would look to the USP storage
conditions for the filtration temperature. Finally, as noted
above, the definition of "controlled room
temperature" seems to vary among pharmacopeias which
begs the question, what is the plain meaning of the term?
Phillips, 415 F.3d at 1318. "[E]xtrinsic evidence may be
useful to the court, but it is unlikely to result in a
reliable interpretation of patent claim scope unless
considered in the context of the intrinsic evidence."
PM///M, 415F.3dat 1319.
The intrinsic record fully supports Defendants'
proposed construction. Markman Hr'g Tr. 26:16-17. The
specification explicitly states that controlled room
temperature includes the range 17.8° to 24.6° C and
that filtration in that range is undesirable because of the
pressure buildup in the second filter. Markman Hr'g Tr.
 The parties' dispute centers on:
(1) whether the reduced temperature filtration, 0° to
17.5° C is maintained for the entirety of the filtration
process; and (2) whether there was a clear disclaimer of all
processes without "improved filterability" in the
'775 parent that carries over to the '993
continuation. Markman Hr'g Tr. 61:1-7, 17-24.
First, Defendants argue that Plaintiffs' proposed
construction broadens the claim by allowing filtration at
virtually any temperature. Markman Hr'g Tr. 64:16-19. In
contrast, Defendants claim their construction accounts for
the POSA's understanding that the temperature is
maintained throughout filtration. Markman Hr'g Tr.
62:18-25. Plaintiffs argue that when the patentee chose to
use the words "is maintained" they did so. Markman
Hr'g Tr. 49:11-14. Specifically, these words appear in
Claim 14, not Claim 1 of the '775 Patent and do not
appear in Claims 1 or 19 of the '993 Patent. Markman
Hr'g Tr. 49:18-22. The court will, therefore, not read
the limitation into the '993 Patent.
Second, Defendants argue that the '993 child must
include the "improved filterability" steps in the
'775 Parent. Markman Hr'g Tr. 72:1-2, 6-12; (D.I. 156
at ¶ 6174-82.) Specifically, Defendants argue when the
parent and child share related subject matter, the child
applicant cannot recapture claim scope previously disclaimed
without notifying the examiner they are rescinding the
disclaimer. Markman Hr'g Tr. 73:1-9, 18-25. The close
relation of subject matter, however, does not conclusively
answer the question of whether the disclaimer travels between
generations of patents. Ormco Corp. v. Align Tech.,
Inc.,498 F.3d 1307, 1314 (Fed. Cir. 2007). At least one
court has determined that the disclaimer in the parent does
not apply to the child when the parent's claim scope
changed as a result of an amendment. Sanofl v. Glenmark
Pharm. Inc., USA, 204 F.Supp.3d 665, 703 (D. Del. 2016).
In that case, the disclaimer made during prosecution of the
parent did not carry over to the child because the amendment
occurred through explicit ...