United States District Court, S.D. California
ORDER ON CLAIM CONSTRUCTION AND DENYING
PLAINTIFF'S MOTION TO STRIKE (ECF Nos. 123, 126,
Janis L. Sammartino, United States District Judge.
before the Court are Plaintiff MediciNova, Inc.'s
(“Pl.'s Br., ” ECF No. 126) and Defendant
Genzyme Corporation's (“Def.'s Br., ” ECF
No. 123) Opening Claim Construction Briefs, as well as each
Party's response to the other's Opening Claim
Construction Brief (“Def.'s Resp., ” ECF No.
134; “Pl.'s Resp., ” ECF No. 135). The
Parties dispute the construction of a single term-“a
stock of recombinant adeno-associated virus”-claimed by
U.S. Patent No. 6, 376, 237 (the “'237
patent”). Also before the Court is Plaintiff's
Motion to Strike Portion's of Genzyme Corporation's
Opening Claim Construction Brief (“Mot. to Strike,
” ECF No. 130), as well as Defendant's Opposition
(“Opp'n, ” ECF No. 132).
Court heard oral argument, including tutorials from the
Parties' respective experts, on June 18, 2019.
See ECF No. 144. Having carefully considered the
Parties' arguments, the evidence, and the law, the Court
DENIES the Motion to Strike and
ADOPTS Genzyme's proposed construction.
The '237 Patent
gene therapy, physicians aim “to treat disease by
infecting a patient's body with genetic material designed
to produce therapeutic material that treats the
disease.” Declaration of M. Curt Lambert in Support of
Def.'s Br. (“Lambert Decl.”) Ex. K at
504.There are various ways to introduce this
therapeutic genetic material, sometimes referred to as a
“heterologous gene, ” see Lambert Decl.
Ex. A (“'237 patent”) at 9:3-20, into a
patient's body, one of which involves the use of
recombinant viruses. '237 patent at 2:1-7. A recombinant
virus is “a virus that has been genetically altered,
e.g., by the addition or insertion of a heterologous nucleic
acid construct into the particle.” '237 patent at
means of viral-mediated gene delivery is the use of
adeno-associated virus (“AAV”) vectors. '237
patent at 2:7-9, 15-16. There are various benefits to using
AAV as compared to other viruses. '237 patent at 2:17-18.
For example, AAV can “infect a wide range of host
cells, including non-dividing cells, ” can
“infect cells from different species, ”
“has not been associated with any human or animal
disease[, ] and does not appear to alter the biological
properties of the host cell upon integration.” '237
patent at 2:18-23. Further, AAV is “stable at a wide
range of physical and chemical conditions.” '237
patent at 2:26-27.
contains a single-stranded deoxyribonucleic acid
(“DNA”) molecule. '237 patent at 2:28-29. The
AAV genome comprises an internal, non-repeating genome that
is flanked on either end by inverted terminal repeats
(“ITRs”). '237 patent at 2:29-31. The
non-repeating genome is itself comprised of AAV replication
(“rep”) and capsid (“cap”) genes,
which code for viral proteins allowing the virus to replicate
and package, respectively, its viral genome into a virion.
'237 patent at 2:36-40. AAV may be engineered to deliver
a therapeutic heterologous gene by deleting the internal,
nonrepeating portion of the AAV genome, i.e., the
rep and cap genes, and inserting the heterologous gene
between the two ITRs. '237 patent at 2:59-62. This is
referred to as an AAV vector. See '237 patent at
produce an infectious recombinant AAV (or “rAAV”)
containing the heterologous gene, the AAV vector and two
other components must be introduced to a suitable host cell.
See '237 patent at 3:1-10. One of these
additional components is a vector, called the “AAV
helper construct, ” see '237 patent at
7:22-40, that contains the AAV rep and cap genes that were
replaced in the AAV vector with the heterologous gene.
See '237 patent at 3:3-7. The other necessary
component is a vector containing accessory function genes.
See '237 patent at 3:7-10. Accessory functions
are “non-AAV derived viral and/or cellular functions
upon which AAV is dependent for its replication, ”
'237 patent at 7:41-43, and the vector containing those
accessory function genes is an “accessory function
vector.” '237 patent at 8:1-3.
these three vectors have been introduced to the host cell,
the heterologous gene is replicated and packaged into a
recombinant virion. '237 patent at 3:11-13. The rAAV
virions can then be used to treat a patient by infecting the
patient's cells. '237 patent at 3:13-14. The
heterologous gene enters and is expressed by the
patient's cells but, because the patient's cells lack
the AAV rep and cap genes and helper virus accessory function
genes necessary for the rAAV to replicate and package its
genome, the rAAV do not further replicate within the
patient's cells. '237 patent at 3:15-19. The absence
of AAV rep and cap genes in the patient's cells also
means that the patient's cells will not produce unwanted
wild-type or pseudo-wild-type AAV. '237 patent at
methods of producing rAAV as of the '237 patent's
filing, however, presented significant problems, including
that the current methods produced too few rAAV to be
therapeutically useful and resulted in the production of
replication-competent pseudo-wild-type AAV. See
'237 patent at 3:22-29. Although many attempts had been
made to address the formation of pseudo-wild-type AAV, none
succeeded. See '237 patent at 3:36- 37. Indeed,
the stocks resulting from U.S. Patent No. 5, 753, 500 (the
“'500 patent”), filed on April 3, 1995 by
Thomas E. Shenk et al., yielded between 0.01 and 10%
wild-type AAV, a level of contamination that would be
unacceptable for human trials. See '237 patent
invention claimed by the '237 patent was intended to
correct these deficiencies by “provid[ing] AAV helper
functions for rAAV production that do not result in the
formation of pseudo-wild-type AAV” and “that
allow high efficiency production of rAAV.” See
'237 patent at 3:48-56. “The rAAV virions produced
using the present invention may be used to introduce genetic
material into animals, including humans, or isolated animal
cells for a variety of research and therapeutic uses.”
'237 patent at 4:42- 45. “For example, rAAV virions
produced using the methods of the present invention may be
used to express a protein in animals to gather preclinical
data or to screen for potential drug candidates.”
'237 patent at 4:45-48. “Alternatively, the rAAV
virions may be used to transfer genetic material into a human
to cure a genetic defect or to effect a desired
treatment.” '237 patent at 4:48-51.
Peter Colosi filed Application No. 09/450, 083 on November
29, 1999, which issued as the '237 patent on April 23,
2002. See generally Lambert Decl. Ex. A. The
'237 patent was itself a continuation of Application No.
09/143, 270, filed on August 28, 1998, and issued as U.S.
Patent No. 6, 001, 650 (the “'650 patent”),
itself a continuation of Application No. 09/107, 708, filed
on June 30, 1998, and issued as U.S. Patent No. 6, 027, 931
(the “'931 patent”), which was a continuation
of Application No. 08/688, 648, filed on July 29, 1996, and
subsequently abandoned, which was a continuation of
Application No. 08/510, 790, filed on August 3, 1995, and
issued as U.S. Patent No. 5, 622, 856. See '237
patent at 1:1-13.
'237 patent, titled “High-Efficiency Wild-Type-Free
AAV Helper Functions, ” contains 17 claims, four of
which are independent. See generally Id. Each of the
17 claims begins with the phrase “[a] stock of
recombinant adeno-associated virus.” See generally
Id. at 23:10-24:65.
The Assignment Agreement
2005, Defendant entered into a written Assignment Agreement
with Avigen, Inc. (“Avigen”). First Am. Compl.
(“FAC, ” ECF No. 13) ¶ 6. Under this
Agreement, Defendant “acquired from Avigen certain gene
therapy intellectual property and gene therapy research and
developmental programs. Avigen, in turn, received
consideration up front and was eligible for specified
milestone payments should certain events and/or conditions be
met in the future.” Id. ¶ 7.
technology acquired by Defendant included the '237
patent. Id. ¶ 13. Defendant owes a milestone
payment to Plaintiff under the Assignment Agreement
“when the first patient is dosed or treated in a Phase
I clinical study with a product that is covered by a claim of
one of the Gene Therapy Patents issued in certain major
markets” such as the United States. Id. ¶
2009, Avigen merged with Plaintiff and Plaintiff assumed all
rights under the Assignment Agreement, including rights to
milestone payments. Id. ¶ 11. In March 2014,
Defendant informed Plaintiff that Defendant was
“currently conducting a Phase 1 clinical trial of a
gene therapy product for age-related macular degeneration
named AAV-sFLT. [Defendant] explained that all patients in
the clinical trial had already been dosed with
AAV-sFLT.” Id. ¶ 12.
alleges that Defendant owes it the $1, 000, 000 milestone
payment because AAV-sFLT is covered by the Agreement.
Id. ¶ 16. As a result, Plaintiff alleges
Defendant breached the Assignment Agreement by not paying
Plaintiff. Id. ¶ 22. Defendant, on the other
hand, contends that AAV-sFLT is not covered by the '237
patent and, consequently, no milestone payment is owed.
See, e.g., Def.'s Br. at 2 n.1.
October 21, 2014, Plaintiff filed a Complaint against
Defendant alleging two causes of action for breach of
contract and breach of covenant of good faith and fair
dealing. See generally ECF No. 1
(“Compl.”). Although nominally a breach of
contract action, Plaintiff conceded in its Complaint that its
“right to relief depends on resolution of a substantial
question of federal patent law.” Id. ¶ 1.
moved to dismiss, see generally ECF No. 3, a request
that the Honorable M. James Lorenz granted with leave to
amend. See generally ECF No. 9. Plaintiff filed the
operative amended complaint on September 4, 2015. See
generally ECF No. 13. After Defendant filed its answer
on September 28, 2015, see generally ECF No. 17, the
Parties engaged in an Early Neutral Evaluation conference,
see ECF No. 23, and proceeded to discovery. See,
e.g., ECF Nos. 25, 35.
August 9, 2017, the case was reassigned to this Court.
See generally ECF No. 55. On November 20, 2017,
Defendant moved for summary judgment as to both of
Plaintiff's causes of action. See generally ECF
Nos. 70, 96. Because Defendant sought claim construction of
the patent term “a stock of recombinant
adeno-associated virus” as part of its motion for
summary judgment, the Court set a status conference for April
19, 2018, to discuss the necessity of a claim construction
hearing. See generally ECF No. 89. Following the
hearing, the Court ordered the Parties to file a joint claim
construction chart, see ECF No. 90, which they filed
on May 3, 2018. See generally ECF No. 93.
their initial joint claim construction chart, Plaintiff
proposed that the disputed term “has a plain and
ordinary meaning to one of ordinary skill in the art and no
construction is necessary.” Id. at 1.
Defendant, on the other hand, proposed either that the
disputed term (1) “exclude recombinant
adeno-associated virus made using accessory functions derived
from the herpes simplex type-1 (HSV-1) virus, ” or (2)
mean “[a] stock of recombinant adeno-associated virus
virions, ” to which the '237 patent's express
definitions for a “recombinant AAV virion” and
“accessory functions” would apply. See
Id. at 1-3.
6, 2018, the Court requested additional briefing from
Plaintiff concerning Defendant's argument that
“[p]rior art cited in the patent demonstrates that the
invention is directed to rAAV virions, ” see
ECF No. 97 (citing ECF No. 96 at 23), in response to which
Plaintiff filed a supplemental brief. See generally
ECF No. 100. On June 11, 2018, the Court invited the Parties
to provide a tutorial or preliminary statement concerning the
'237 patent and underlying technical issues. See
generally ECF No. 98.
Court held a hearing on Defendant's motion for summary
judgment and the related claim construction issue on August
6, 2018. See generally ECF No. 111. At the end of
the hearing, after months of briefing and hours of oral
argument, see generally ECF Nos. 70, 86, 87, 93,
100, 113, Plaintiff's counsel contended that it had
“not fully briefed claim construction” and
requested “the opportunity to have additional briefing
on this subject.” ECF No. 113 (“Aug. 6, 2018
Tr.”) at 91:14-25.
the Court found that “it d[id] not have adequate
information to engage in a sufficient claim construction
analysis, ” denying without prejudice Defendant's
motion for summary judgment, see ECF No. 112 at 1,
and setting a second claim construction hearing. See
ECF No. 115.
preliminary matter, Plaintiff requests that the Court strike
Exhibits L, M, N, P, and Q to Defendant's Brief and those
portions of Defendant's Brief relying on those exhibits,
specifically page 13, line 9 through page 14, line 28,
failure “to include [those exhibits] in the
parties' Joint Claim Construction Chart (ECF No. 117), as
required by the Patent Local Rule
4.2([b]).” See ECF No. 130
(“Not.”) at 1.
Motion to Strike is brought pursuant to Federal Rule of Civil
Procedure 37 and Patent Local Rule 4.2(b). Pursuant to Patent
Local Rule 4.2(b),
Each party's proposed construction of each disputed claim
term, phrase, or clause, must identify all references from
the specification or prosecution history that support that
construction, and identify any extrinsic evidence known to
the party on which it intends to rely either to support its
proposed construction of the claim or to oppose any
party's proposed construction of the claim, including,
but not limited to, as permitted by law, dictionary
definitions, citations to learned treatises and prior art,
and testimony of percipient and expert witnesses.
Plaintiff does not specify whether its Motion to Strike is
brought pursuant to Federal Rule of Civil Procedure 37(b) or
(c), the Court concludes that Rule 37(b) is the proper
provision. See Pulse Eng'g, Inc. v. Mascon,
Inc., No. 08CV0595JM(AJB), 2009 WL 250058, at *2 (S.D.
Cal. Feb. 3, 2009) (“The relevant local patent rules
here are ‘essentially a series of case management
orders.'”) (citing Integrated Circuit Sys. v.
Realtek Semiconductor Co., 308 F.Supp.2d 1106, 1107
(N.D. Cal. 2004)). Rule 37(b) gives courts the power to
impose sanctions on parties who do not comply with their
orders, including “prohibiting the disobedient party .
. . from introducing designated matters in evidence.”
Fed.R.Civ.P. 37(b)(2)(A)(ii). Unless a proposed sanction
implicates dismissal of an action, the court need not
identify “willfulness, fault, or bad faith, ”
even if the sanction is severe. Yeti by Molly, Ltd. v.
Deckers Outdoor Corp., 259 F.3d 1101, 1106 (9th Cir.
2001). A district court has wide discretion in determining
the appropriateness of issuing sanctions. Id.;
Navellier v. Slettenm, 262 F.3d 923, 947 (9th Cir.
2001). Exclusion of evidence is “particularly
appropriate ‘where the undisclosed information is
significant and the party failing to make the timely
disclosure lacked diligence.'” Pulse Eng'g,
Inc., 2009 WL 250058, at *2 (quoting MGM Well Serv.,
Inc. v. Mega Lift Sys., LLC, No. H-05-1634, 2007 WL
433283, at *2 (S.D. Tex. Jan. 24, 2007)).
claims that striking Defendant's Exhibits L, M, N, P, and
Q and those portions of its Defendant's Brief relying on
those exhibits is merited because Plaintiff “was
prejudiced because it was not able to address
[Defendant's new] exhibits and novel arguments in its
Opening Claim Construction Brief (which is 25 pages,
significantly longer than the 10 page Responsive Claim
Construction Brief).” Mot. to Strike at 8. Defendant
counters that the purportedly “new” exhibits
“are all part of the prosecution history of the
'237 patent, which Genzyme produced to MediciNova nearly
two years ago, ” Opp'n at 5, and which Defendant
listed in the Joint Claim Construction Chart. See
Id. at 6-10. Further, Defendant contends that it has not
raised any “‘new' arguments and legal
theories” because its “position is
straightforward and has been asserted . . . for two
years.” Id. at 5. Indeed, “MediciNova
has had the benefit of possessing Genzyme's claim
construction positions and evidence for a long time, ”
which “starkly contrasts the position that Genzyme is
in: MediciNova finally, after being reprimanded and forced by
the Court, has engaged in claim construction, and thus
Genzyme only recently received MediciNova's claim
construction positions.” Id. at 10-11.
Court concludes that Plaintiff has not met its burden of
showing that exclusion is warranted here. Not only did
Plaintiff itself cite in its Brief to materials not listed in
the Parties' Joint Claim Construction Chart, see
Opp'n at 10 n.3; see also Declaration of M. Curt
Lambert in Support of Opposition (ECF No. 138-1) ¶ 2,
but Defendant did list prosecution history of the '237
patent in the Joint Claim Construction Chart. See
ECF No. 117 at 8-9. Further, the May 1, 2001 Amendment-listed
by both Parties in the Joint Claim Construction Chart,
see Id. at 6 (Plaintiff), 8-9 (Defendant), was made
in response to Defendant's Exhibits L, M, and N,
see Opp'n at 7, and Plaintiff itself listed
Exhibit P in its Joint Claim Construction Chart. See
ECF No. 117 at 6. In any event, Plaintiff has had the
239-page prosecution history of the '237 patent since
February 6, 2017. Lambert Strike Decl. ¶ 3. Over two
years later, nothing contained therein should be
“new” to Plaintiff, particularly over four years
into this litigation and on the second round of claim
the Court DENIES Plaintiff's Motion to
Strike. See, e.g., Pulse Eng'g, Inc.,
2009 WL 250058, at *3 (“[The defendant]'s
disorderly revelation of supporting extrinsic evidence would
seem to have little, if any, effect on [the plaintiff]'s
ability to present its own interpretations of various patent
terms. The court finds [the plaintiff] neither faces nor has
faced any prejudice as a result of the reference
construction is a matter of law for determination by the
court. Markman v. Westview Instruments, Inc., 517
U.S. 370, 388 (1996) (“[J]udges, not juries, are the
better suited to find the acquired meaning of patent
of a claim are “generally given their ordinary and
customary meaning.” Vitronics Corp. v.
Conceptronic, Inc., 90 F.3d 1576, 1582 (Fed. Cir. 1996).
“[T]he ordinary and customary meaning of a claim term
is the meaning that the term would have to a person of
ordinary skill in the art in question at the time of the
invention, i.e., as of the effective filing date of the
patent application.” Phillips v. AWH Corp.,
415 F.3d 1303, 1313 (Fed. Cir. 2005) (en banc). Because the
inquiry into the meaning of claim terms is an objective one,
“a court looks to those sources available to the public
that show what a person of skill in the art would have
understood disputed claim language to mean.”
Innova/Pure Water, Inc. v. Safari Water Filtration Sys.,
Inc., 381 F.3d 1111, 1116 (Fed. Cir. 2004). “Those
sources include the words of the claims themselves, the
remainder of the specification, the prosecution history, and
extrinsic evidence concerning relevant scientific principles,
the meaning of technical terms, and the state of the
art.” Id. (citing Vitronics,
90 F.3d at 1582-83).
construction begins with an analysis of the words of the
claims themselves. See Scanner Techs. Corp. v. ICOS
Vision Sys. Corp., 365 F.3d 1299, 1303 (Fed. Cir. 2004)
(holding that claim construction “begins and
ends” with a claim's actual words). “In some
cases, the ordinary meaning of claim language as understood
by a person of skill in the art may be readily apparent even
to lay judges, and claim construction in such cases involves
little more than the application of the widely accepted
meaning of commonly understood words.”
Phillips, 415 F.3d at 1314. The meaning of a claim
term as understood by ordinarily skilled artisans, however,
often is not immediately apparent. Id. In those
situations, the court looks to “sources available to
the public that show what a person of skill in the art would
have understood disputed claim language to mean.”
Id. Or, when a patentee “chooses to be his own
lexicographer and use terms in a manner other than their
ordinary meaning, ” the court can use the
patentee's meaning “as long as the special
definition of the term is clearly stated in the patent
specification or file history.” Vitronics, 90
F.3d at 1582.
examining the claims themselves, “the context in which
a term is used can be highly instructive.”
Phillips, 415 F.3d at 1314. Moreover, “[o]ther
claims of the patent in question, both asserted and
unasserted can . . . be valuable sources of enlightenment as
to the meaning of a claim term.” Id. (citing
Vitronics, 90 F.3d at 1582). “Because claim
terms are normally used consistently throughout the patent,
the usage of a term in one claim can often illuminate the
meaning of the same term in other claims.” Id.
Conversely, under the doctrine of claim differentiation,
“‘different words or phrases used in separate
claims are presumed to indicate that the claims have
different meanings and scope.'” Andersen Corp.
v. Fiber Composites, LLC, 474 F.3d 1361, 1369 (Fed. Cir.
2007) (quoting Karlin Tech., Inc. v. Surgical Dynamics,
Inc., 177 F.3d 968, 971-72 (Fed. Cir. 1999)).
the person of ordinary skill in the art is deemed to read the
claim term not only in the context of the particular claim in
which the disputed term appears, but in the context of the
entire patent, including the specification.”
Phillips, 415 F.3d at 1313. “The specification
acts as a dictionary when it expressly defines terms used in
the claims or when it defines them by implication.”
Vitronics, 90 F.3d at 1582. “In addition to
providing contemporaneous technological context for defining
claim terms, the patent applicant may also define a claim
term in the specification ‘in a manner inconsistent
with its ordinary meaning.'” Metabolite Labs.,
Inc. v. Lab. Corp. of Am., 370 F.3d 1354, 1360 (Fed.
Cir. 2004). “Usually, [the specification] is
dispositive; it is the single best guide to the meaning of a
disputed term.” Vitronics, 90 F.3d at 1582;
accord Phillips, 415 F.3d at 1317 (“It is . .
. entirely appropriate for a court, when conducting claim
construction, to rely heavily on the written description for
guidance as to the meaning of the claims.”).
claims should ordinarily be construed to encompass the
preferred embodiments described in the specification, for
“[a] claim construction that excludes a preferred
embodiment . . . ‘is rarely, if ever,
correct.'” SanDisk Corp. v. Memorex Prods.,
Inc., 415 F.3d 1278, 1285 (Fed. Cir. 2005) (quoting
Vitronics, 90 F.3d at 1583). However, a court should
not import limitations from the specification into the
claims, Phillips, 415 F.3d at 1323
(“[A]lthough the specification often describes very
specific embodiments of the invention, we have repeatedly
warned against confining the claims to those
embodiments.”), absent a specific reference in the
claims themselves, Reinshaw PLC v. Marposs Societa'
per Azioni, 158 F.3d 1243, 1248 (Fed. Cir. 1998)
(“[A] party wishing to use statements in the written
description to confine or otherwise affect a patent's
scope must, at the very least, point to a term or terms in
the claim with which to draw in those statements.”).
patent's prosecution history, if in evidence, may also
shed light on claim construction. Vitronics, 90 F.3d
at 1582. “This history contains the complete record of
all proceedings before the Patent and Trademark Office
[(“PTO”)], including any express representations
made by the applicant regarding scope of the claims.”
Id. “Like the specification, the prosecution
history provides evidence of how the PTO and the inventor
understood the patent.” Phillips, 415 F.3d at
1317. Although the prosecution history “often lacks the
clarity of the specification, ” it is nevertheless
useful to show “how the inventor understood the
invention and whether the inventor limited the invention in
the course of prosecution, making the claim scope narrower
than it would otherwise be.” Id.
most situations, an analysis of the intrinsic evidence alone
will resolve any ambiguity in a disputed claim term. In such
circumstances, it is improper to rely on extrinsic
evidence.” Vitronics, 90 F.3d at 1583. Thus,
expert testimony on the proper construction of disputed claim
terms “may only be relied upon if the patent documents,
taken as a whole, are insufficient to enable the court to
construe disputed claim terms.” Id. at 1585.
Vitronics does not state a rule of admissibility,
nor does it “prohibit courts from examining extrinsic
evidence, even where the patent document is itself
clear.” Pitney Bowes, Inc. v.
Hewlett-Packard Co., 182 F.3d 1298, 1308 (Fed. Cir.
1999). As the Federal Circuit has made clear:
[B]ecause extrinsic evidence can help educate the court
regarding the field of the invention and can help the court
determine what a person of ordinary skill in the art would
understand claim terms to mean, it is permissible for the
district court in its sound discretion to admit and use such
Phillips, 415 F.3d at 1319; accord Key Pharms.
v. Hercon Labs. Corp., 161 F.3d 709, 716 (Fed. Cir.
1998) (“[T]rial courts generally can hear expert
testimony for background and education on the technology
implicated by the presented claim construction issues, and
trial courts have broad discretion in this regard.”).
The court is not “barred from considering any
particular sources or required to analyze sources in any
specific sequence, as long as those sources are not used to
contradict claim meaning that is unambiguous in light of the
intrinsic evidence.” Phillips, 415 F.3d at
1324; see also Biagro W. Sales, Inc. v. Grow More,
Inc., 423 F.3d 1296, 1302 (Fed. Cir. 2005)
(“Extrinsic evidence, such as expert testimony, may be
useful in claim construction, but it should be considered in
the context of the intrinsic evidence.”).
their Joint Claim Construction Chart, the Parties identify
the sole disputed claim term as “a stock of recombinant
adeno-associated virus, ” also abbreviated as “a
stock of recombinant AAV” or “a stock of
rAAV.” ECF No. 117 at 2, 6. Each of the 17 claims of
the '237 patent claims begins with-and therefore
claims-“[a] stock of recombinant adeno-associated
virus.” See '237 patent at 23:10-24:64.
there are four independent claims, see '237
patent at 23:11-26 (claim 1), 23:37-42 (claim 4), 23:59-24:19
(claim 8), 24:32-37 (claim 11), the Parties' Opening
Briefs focus on claim 1, which they agree is representative.
See, e.g., Def.'s Br. at 2-3; Pl.'s Br. at
10-11. Claim 1 of the '237 patent claims:
A stock of recombinant adeno-associated virus free of
wild-type adeno-associated virus, wherein the recombinant
adeno-associated virus comprises a packaged recombinant
adeno-associated virus vector containing a heterologous gene
of interest but lacking adeno-associated virus genes required
for replication or packaging of said adeno-associated virus
vector, and wherein wild-type adeno-associated virus is not
detectable by a method comprising:
(a) isolating viral DNA from the stock of recombinant
(b) performing about 35 rounds of polymerase chain reaction
(“PCR”) on the viral DNA under PCR conditions
designed to selectively amplify DNA sequences from ...