3-D Matrix, Inc. et al v. Menicon Co. Ltd. et al
Filing
59
Judge Indira Talwani: MEMORANDUM AND ORDER entered: For the reasons set forth in the attached Memorandum and Order, the claim terms in this matter are construed as follows:1. The term homogeneous means of the same character structure, qual ity, etc.; essentially like; of the same nature.2. The term amphiphilic peptides, means peptides that contain hydrophobic and hydrophilic regions along their lengths.3. The term complementary means the ability of peptides to interact th rough ionized pairs or hydrogen bonds.4. The term structurally compatible means the ability of complementary peptides to maintain a constant distance between their peptide backbones.5. The term membrane means a thin sheet or layer that moderates permeation.6. The term alternating hydrophobic and hydrophilic amino acids means completely alternating hydrophobic and hydrophilic amino acids, i.e. no adjacent amino acids are both hydrophobic or both hydrophilic.(MacDonald, Gail)
UNITED STATES DISTRICT COURT
DISTRICT OF MASSACHUSETTS
3-D MATRIX, INC., et al.,
Plaintiffs,
v.
MENICON CO. LTD., et al.,
Defendants.
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*
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Civil Action No. 14-cv-10205-IT
MEMORANDUM & ORDER
January 11, 2016
TALWANI, D.J.
I.
Introduction
Plaintiffs 3-D Matrix, Inc., 3-D Matrix Ltd., and the Massachusetts Institute of
Technology (“Plaintiffs”) bring this suit alleging that Defendants Menicon Co. Ltd. and BBridge International, Inc. (“Defendants”) infringe Plaintiffs’ patents, including United States
Patent Nos. 5,670,483 (the “’483 Patent”) and 5,955,343 (the “’343 Patent”) (collectively, the
“Patents-in-Suit”). The parties have asked the court to construe seven claim terms contained in
the Patents-in-Suit. After reviewing the parties’ filings and holding a Markman hearing, the
court issues the following claim construction.
II.
Patents-in-Suit
This lawsuit involves two patents relating to the self-assembly of certain peptides into
macroscopic membranes. See ’483 Patent, col. 1, ll. 34-35 (“This invention relates to the selfassembly of peptides into stable macroscopic membranes.”). According to the patentees, these
membranes are “potentially useful in biomaterial applications such as slow-diffusion drug
delivery systems, artificial skin, and separation matrices . . . .” ’343 Patent, Abstract. Plaintiffs
in this action allege that Defendants’ product “PanaceaGel” infringes claims in the Patents-inSuit. See Compl. [#1]. The Patents-in-Suit have similar specifications, and the ’343 Patent is a
“continuation-in-part of the ’483 Patent.” Pls.’ Opening Claim Constr. Br. 2 [#42]. The ’483
Patent was filed on November 30, 1994, and issued on September 23, 1997. The ’343 Patent
was filed on August 22, 1994, and issued on September 21, 1999.
III.
Legal Framework
The construction of claim terms is a question of law. Markman v. Westview Instruments,
517 U.S. 370, 372 (1996) (“[T]he construction of a patent, including terms of art within its claim,
is exclusively within the province of the court.”). “[T]he words of a claim ‘are generally given
their ordinary and customary meaning.’” Phillips v. AWH Corp., 415 F.3d 1303, 1312 (Fed. Cir.
2005) (en banc) (citation omitted). “[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 effective filing date of the patent application.” Id. at 1313. In construing claim
terms, courts look to “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. at 1314 (quoting Innova/Pure Water, Inc. v.
Safari Water Filtration Sys., Inc., 381 F.3d 1111, 1116 (Fed. Cir. 2004)).
A.
The Language of the Claims
The claim construction analysis begins with the claims themselves. Id. at 1312. The
claims of a patent “define the invention to which the patentee is entitled the right to exclude.” Id.
(quoting Innova, 381 F.3d at 1115). “[T]he context in which a term is used in the asserted claim
may be highly instructive.” Id. at 1314; see id. (“This court’s cases provide numerous . . .
examples in which the use of a term within the claim provides a firm basis for construing the
2
term.”). For example, “[b]ecause 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. Additionally, “the presence of a dependent claim that adds a particular
limitation gives rise to a presumption that the limitation in question is not present in the
independent claim.” Id. at 1315.
B.
The Specification
The claims “do not stand alone” but “are part of ‘a fully integrated written instrument,’
consisting principally of a specification . . . .” Id. at 1315 (internal citation omitted). “For this
reason, claims ‘must be read in view of the specification, of which they are a part.’” Id. (quoting
Markman v. Westview Instruments, Inc., 52 F.3d 967, 979 (Fed. Cir. 1995) (“Markman I”).
“[T]he specification ‘is always highly relevant to the claim construction analysis. Usually it is
dispositive; it is the single best guide to the meaning of a disputed term.’” Id. (quoting Vitronics
Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1582 (1996)).
“[T]he specification may reveal a specific definition given to a claim term by the patentee
that differs from the meaning it would otherwise possess. In such cases, the inventor’s
lexicography governs.” Id. at 1316; see CCS Fitness, Inc. v. Brunswick Corp., 288 F.3d 1359,
1366 (Fed. Cir. 2002) (stating that an inventor may “act as his own lexicographer” by “clearly
set[ting] forth a definition of a disputed term in the specification”). “In other cases, the
specification may reveal an intentional disclaimer, or disavowal, of the claim scope by the
inventor.” Phillips, 415 F.3d at 1316. Nevertheless, the court must be careful to “us[e] the
specification [only] to interpret the meaning of a claim” and not to “import[] limitations from the
specification into the claim.” Id. at 1323; see also id. (“[A]lthough the specification often
describes very specific embodiments of the invention, we have repeatedly warned against
3
confining the claims to those embodiments.”). Although this distinction “can be a difficult one
to apply in practice[,] . . . the line between construing terms and importing limitations can be
discerned with reasonable certainty and predictability if the court’s focus remains on
understanding how a person of ordinary skill in the art would understand the claim terms.” Id.
C.
The Patent Prosecution History
In construing claim terms, courts should also consider the patent’s prosecution history.
Id. at 1317. The prosecution history consists of the record of the proceedings before the United
States Patent and Trademark Office (“PTO”) and prior art cited during the examination of the
patent. Id. “Like the specification, the prosecution history provides evidence of how the PTO
and the inventor understood the patent.” Id. The prosecution history can also provide evidence
as to “whether the inventor limited the invention in the course of the prosecution, making the
claim scope narrower than it would otherwise be.” Id. “Yet because the prosecution history
represents an ongoing negotiation between the PTO and the applicant, rather than the final
product of that negotiation, it often lacks the clarity of the specification and thus is less useful for
claim construction purposes.” Id. As a result, courts must “not rely on the prosecution history to
construe the meaning of the claim term to be narrower than it would otherwise be unless a
patentee limited or surrendered claim scope through a clear and unmistakable disavowal.” 3M
Innovative Props. Co. v. Tredegar Corp., 725 F.3d 1315, 1322 (Fed. Cir. 2013).
D.
Extrinsic Evidence
Extrinsic evidence consists of “all evidence external to the patent and prosecution history,
including expert and inventor testimony, dictionaries, and learned treatises.” Phillips, 415 F.3d
at 1317 (quoting Markman I, 52 F.3d at 980). “[W]hile extrinsic evidence can shed useful light
on the relevant art, . . . it is less significant than the intrinsic record in determining the legally
4
operative meaning of the claim language.” Id. (internal quotation marks and citation omitted).
This is because extrinsic evidence suffers from a number of defects, including its independence
from the patent, potential bias, and varying relevance. Id. at 1318-19. Such evidence is
therefore “unlikely to result in a reliable interpretation of patent claim scope unless considered in
the context of the intrinsic evidence.” Id. at 1319.
IV.
Analysis
A.
“Homogeneous”
The parties agree upon the definition of “homogeneous” as “of the same character
structure, quality, etc.; essentially like; of the same nature.” See Joint Claim Constr. and PreHr’g Statement [#48]. The court adopts the parties’ agreed-upon definition of this term.
B.
“Amphiphilic Peptides”
The term “amphiphilic peptides” appears throughout the ’483 and ’343 Patents. Its use in
Claim 1 of the ’483 Patent is typical:
1. A macroscopic membrane which is formed by the self-assembly of amphiphilic
peptides in an aqueous solution containing monovalent metal cations, wherein the
peptides contain 12 or more amino acids, have alternating hydrophobic and
hydrophilic amino acids and are complementary and structurally compatible.
The parties’ proposed constructions of this term are as follows:
Disputed Term
Plaintiffs’ Construction
Defendants’ Construction
“amphiphilic peptides”
No construction necessary;
the plain and ordinary
meaning applies.
“all of the amino acids of the
peptides are either
hydrophobic or hydrophilic,
and the peptides have
alternating hydrophobic and
hydrophilic amino acids”
Ordinary meaning: “peptides
that contain hydrophobic and
hydrophilic regions along
their lengths”
Plaintiffs contend that the ordinary meaning of the term “amphiphilic peptides” is
5
“peptides [that] contain hydrophobic and hydrophilic regions along their lengths,” and that the
ordinary meaning of the term controls. See Pls.’ Responsive Claim Constr. Br. 2 [#46].
Defendants do not disagree with Plaintiffs’ articulation of the ordinary meaning of “amphiphilic
peptides.” See Defs.’ Opening Claim Constr. Br. 4 [#43] (“At a fundamental level amphiphilic
peptides contain hydrophobic and hydrophilic regions along their lengths.”); see also
Amphiphilic, ACADEMIC PRESS DICTIONARY OF SCI. & TECH. 100 (Academic Press, Inc. 1992), in
Pls.’ Carnevale Decl. Ex. C [#44-3] (defining “amphiphilic” as “describing a substance
containing both polar, water-soluble groups and non-polar, water-insoluble groups”). Rather,
Defendants argue that the patentees in this case acted as their own lexicographers and redefined
the term “amphiphilic peptides,” and that the patentees’ lexicography governs.
“The plain meaning of claim language ordinarily controls.” InterDigital Commc’ns, LLC
v. Int’l Trade Cmm’n, 690 F.3d 1318, 1324 (Fed. Cir. 2012). There are two exceptions to this
general rule: “1) when a patentee sets out a definition and acts as [its] own lexicographer, or 2)
when the patentee disavows the full scope of a claim term either in the specification or during
prosecution.” Aventis Pharma S.A. v. Hospira, Inc., 675 F.3d 1324, 1330 (Fed. Cir. 2012)
(quoting Thorner v. Sony Comput. Entm’t Am. LLC, 669 F.3d 1362, 1365 (Fed. Cir. 2012)).
“To act as its own lexicographer, . . . ‘the patentee must clearly express an intent’ to redefine the
term.” Id. (quoting Thorner, 669 F.3d at 1365). Thus, the question presented is whether the
language of the claim language, specification, and prosecution history reflect a clear intent on the
part of the patentees in this case to redefine the term “amphiphilic peptides” as something other
than its ordinary meaning. The court finds no such clear intent here.
First, the language of the claims is more consistent with the ordinary meaning of
“amphiphilic peptides” than with Defendants’ proposed construction. Defendants’ proposed
6
construction of “amphiphilic peptides” as peptides having “alternating hydrophobic and
hydrophilic amino acids” would render claim language redundant and the term “amphiphilic”
superfluous. See ’483 Patent, Claim 1 (“A macroscopic membrane formed by the self-assembly
of amphiphilic peptides . . . wherein the peptides . . . have alternating hydrophilic and
hydrophobic amino acids . . . .” (emphasis added)); see also Haemonetics Corp. v. Baxter
Healthcare Corp., 607 F.3d 776, 781 (Fed. Cir. 2010) (“[Courts] construe claims with an eye
toward giving effect to their terms.”); Merck & Co. v. Teva Pharm. USA, Inc., 395 F.3d 1364,
1372 (Fed. Cir. 2005) (“A claim construction that gives meaning to all the terms of the claim is
preferred over one that does not do so.”); Deere & Co. v. Bush Hog, LLC, 703 F.3d 1349, 1354
(Fed. Cir. 2012) (construing claim term in a manner so as to “not render the term superfluous”).
Second, the prosecution history reflects that the patentees originally described Claim 1 as
“[a] macroscopic membrane which is formed by self-assembly of amphiphilic peptides in an
aqueous solution containing monovalent metal cations.” Pls.’ Supp. Decl. Carnevale Ex. C at 2
[#47-3]. The prosecution history further reflects that the patentees, in response to a PTO office
action, later added the phrase “wherein the peptides have alternating hydrophobic and
hydrophilic amino acids.” Id. The patentees’ later insertion of the requirement for “alternating
hydrophobic and hydrophilic amino acids” suggests that the patentees did not understand the
term “amphiphilic peptides” to include such a requirement.
Finally, the specifications do not demonstrate a clear intent on the part of the patentee to
redefine “amphiphilic peptides.” Defendants point to language in the specifications stating:
“Peptides which form membranes are characterized as being amphiphilic, i.e. having alternating
hydrophobic and hydrophilic amino acid residues . . . .” ’483 Patent, col. 1, ll. 36-41 (emphasis
added). However, the use of “i.e.” does not invariably indicate that the patentee intended to act
7
as its own lexicographer. Rather, whether the patentee used the term “i.e.” in a definitional sense
must be determined in context. See Toshiba Corp. v. Imation Corp., 681 F.3d 1358, 1370 (Fed.
Cir. 2012) (concluding that patentee’s use of phrase “each side of the disc—i.e., each recording
plane,” when read in context, was not definitional); Pfizer, Inc. v. Teva Pharm., USA, Inc., 429
F.3d 1364, 1373-74 (Fed. Cir. 2005) (holding that patentee’s reference to “saccharides (i.e.,
sugars)” was not definitional in view of other patent language and extrinsic evidence as to the
ordinary meaning of “saccharides”). Significantly, the ’343 specification also includes the
language: “Peptides which form membranes are characterized as being amphiphilic, e.g., having
alternating hydrophobic and hydrophilic amino acid residues . . . .” ’343 Patent, col. 1, ll. 49-51
(emphasis added). The specifications’ interchangeable use of “i.e” and “e.g.” creates ambiguity
as to whether the patentee intended to redefine the term “amphiphilic peptides” to require
alternating hydrophobic and hydrophilic amino acids, or intended to use peptides with alternating
hydrophobic and hydrophilic amino acids as an example of “amphiphilic peptides."
Absent a clear expression of intent on the part of the patentee to redefine the term
“amphiphilic peptides,” the court construes the term in accordance with its ordinary meaning as
“peptides that contain hydrophobic and hydrophilic regions along their lengths.”
C.
“Complementary” and “Structurally Compatible”
The terms “complementary” and “structurally compatible” appear in numerous claims in
the ’483 and ’343 Patents. Their use in Claims 1 and 37 of the ’483 Patent is typical:
1. A macroscopic membrane which is formed by the self-assembly of amphiphilic
peptides in an aqueous solution containing monovalent metal cations, wherein the
peptides contain 12 or more amino acids, have alternating hydrophobic and
hydrophilic amino acids and are complementary and structurally compatible.
37. A method for forming a macroscopic membrane comprising forming an aqueous
mixture of peptides, which are 12 or more amino acids in length, have alternating
nonpolar and hydrophilic amino acids, and are complementary and structurally
8
compatible, and monovalent metal cations under conditions suitable for selfassembly of the peptide into the macroscopic membrane and allowing the membrane
to be formed.
The parties’ proposed constructions of these terms are as follows:
Disputed Term
Plaintiffs’ Construction
Defendants’ Construction
“complementary”
“the ability of peptides to interact
through ionized pairs or hydrogen
bonds”
“the peptides form ionized
pairs between each of the
hydrophilic side chains”
“structurally compatible”
“the ability of complementary
peptides to maintain a constant
distance between their peptide
backbones”
“the peptides maintain a
constant distance between
their peptide backbones”
Plaintiffs argue that the patentees acted as their own lexicographers by clearly setting
forth definitions of the terms “complementary” and “structurally compatible” in the
specifications, and that the patentees’ lexicography controls. Accordingly, Plaintiffs propose
constructions of the terms “complementary” and “structurally compatible” that track the
patentees’ definitions in the specifications. See ’483 Patent, col. 1, ll. 40-44 (“Complementary
refers to the ability of the peptides to interact through ionized pairs and/or hydrogen bonds which
form between their hydrophilic side-chains.”); ’483 Patent, col. 1, ll. 43-46 (“[S]tructurally
compatible refers to the ability of complementary peptides to maintain a constant distance
between their peptide backbones.”); ’483 Patent, col. 5, ll. 12-16 (“An additional stabilizing
factor is that complementary peptides maintain a constant distance between the peptide
backbones. Peptides which can maintain a constant distance upon pairing are referred to herein
as structurally compatible.”).
Defendants agree that the patentees acted as their own lexicographers and set forth
definitions of these terms. See Defs.’ Reply Claim Constr. Br. 11 [#45] (“Both sides agree that
9
the patentee provided a definition of the term ‘complementary’ in all of the asserted claims.”); id.
at 13 (“[T]he parties agree that the patentees acted as their own lexicographers.”). Nevertheless,
Defendants urge the court to reject the patentees’ lexicography. In doing so, Defendants argue
that the claims require that the peptides actually bond and maintain a constant distance between
their peptide backbones, not merely that the peptides have the ability to do so.
The court finds clear intent on the part of the patentees in this instance to act as their own
lexicographers and redefine the terms “complementary” and “structurally compatible.” The
specifications expressly set forth definitions of these terms. Moreover, the language of the
claims is consistent with the patentees’ lexicography and inconsistent with Defendants’ proposed
construction. The language of Claim 37 of the ’483 Patent suggests that the terms
“complementary” and “structurally compatible” describe characteristics of the peptides before
the peptides interact and form membranes. See ’483 Patent, Claim 37 (describing a “method for
forming a macroscopic membrane comprising forming an aqueous mixture of peptides, which
are . . . complementary and structurally compatible . . . and allowing the membrane to be
formed”). Consistent with this claim language, the patentees defined “complementary” and
“structurally compatible” as characteristics of the peptides whether or not the peptides have yet
interacted, bonded, and formed a membrane. See ’483 Patent, col. 1, ll. 40-44 (“Complementary
refers to the ability of the peptides to interact through ionized pairs and/or hydrogen bonds which
form between their hydrophilic side-chains.” (emphasis added)); ’483 Patent, col. 1, ll. 43-46
(“Structurally compatible refers to the ability of complementary peptides to maintain a constant
distance between their peptide backbones.” (emphasis added)). In contrast, Defendants’
proposed constructions of “complementary” and “structurally compatible,” as applied to method
Claim 37, would require an impossibility—that the peptides actually form pairs and maintain a
10
constant distance between their backbones before the peptides interact and form a membrane.
Finally, the prosecution history suggests that the PTO Examiner adopted the patentees’
definitions during examination of the patent. See Defs.’ Ex. C, 3DM 000705-06 [#43-4] (“The
specification shows that peptides capable of forming macroscopic membranes must . . . be
‘complementary,’ defined by Applicants as capable of ion-pair or hydrogen bonding interactions
between side chains . . . [and] be ‘structurally compatible,’ defined by Applicants as capable of
maintaining a constant distance between peptide backbones . . . .”).
Defendants urge the court to reject the patentees’ lexicography on the ground that the
claims are “product-by-process” claims that require that the peptides actually bond and maintain
a constant distance between their peptide backbones, not merely that the peptides have the ability
to do so. “A product-by-process claim is ‘one in which the product is defined at least in part in
terms of the method or process by which it is made.’” SmithKline Beecham Corp. v. Apotex
Corp., 439 F.3d 1312, 1315 (Fed. Cir. 2006) (quoting Bonito Boats, Inc. v. Thunder Craft Boats,
Inc., 489 U.S. 141, 158 (1989)). “[P]rocess terms that define the product in a product-by-process
claim serve as enforceable limitations.” Abbott Labs. v. Sandoz, Inc., 566 F.3d 1282, 1291 (Fed.
Cir. 2009); see id. at 1295 (construing “obtainable by” as a process term with the meaning
“obtained by” in a product-by-process claim).
Even if the court were to construe the claims at issue as a product-by-process claims, the
terms “complementary” and “structurally compatible” are not process terms. “Complementary”
and “structurally compatible” do not describe steps or acts in a manufacturing process, but rather
describe characteristics of the peptides used in the asserted process. See 3M Innovative Props.
Co. v. Avery Dennison Corp., 350 F.3d 1365, 1371-73 (Fed. Cir. 2003) (holding that
“superimposed” was not a process term but instead “describes a structural relationship between
11
the embossed patterns”); Hazani v. United States Int’l Trade Comm’n, 126 F.3d 1473, 1479
(Fed. Cir. 1997) (concluding that “chemically engraved” was not a process term); Vanguard
Prods. Co. v. Parker Hannifin Corp., 234 F.3d 1370, 1372 (Fed. Cir. 2000) (construing the term
“integral” to describe a structural relationship rather than a manufacturing process); see also 3M
Innovative Properties Co., 350 F.3d at 1371 (“[E]ven words of limitation that can connote with
equal force a structural characteristic of the product or a process of manufacture are commonly
and by default interpreted in their structural sense . . . .”).
The court sees no basis for departing from the patentees’ lexicography. Accordingly, the
court adopts Plaintiffs’ proposed construction of “complementary” as “the ability of peptides to
interact through ionized pairs or hydrogen bonds,” and adopts Plaintiffs’ proposed construction
of “structurally compatible” as “the ability of complementary peptides to maintain a constant
distance between their peptide backbones.”
D.
“macroscopic membrane”
The term “macroscopic membrane” appears throughout the ’483 and ’343 Patents. Its
use in Claim 1 of the ’483 Patent and Claim 1 of the ’343 Patent is typical:
1. A macroscopic membrane which is formed by the self-assembly of amphiphilic
peptides in an aqueous solution containing monovalent metal cations, wherein the
peptides contain 12 or more amino acids, have alternating hydrophobic and
hydrophilic amino acids and are complementary and structurally compatible.
’483 Patent, Claim 1.
1. A method for in vitro cell culture comprising:
a) adding a macroscopic membrane which is formed by the self-assembly of
amphiphilic peptides in an aqueous solution containing monovalent metal
cations, wherein the peptides are 12 or more amino acids . . . , to a call culture
medium comprising cells, thereby forming a membrane/culture mixture . . . .
’343 Patent, Claim 1.
The parties’ proposed constructions of this term are as follows:
12
Disputed Term
Plaintiffs’ Construction
Defendants’ Construction
“macroscopic membrane”
No construction necessary.
The preamble is not a
limitation on the claims.
“A thin sheet or layer.”
Alternatively, “a macroscopic
material of interwoven
filaments.”
Plaintiffs assert that the term “macroscopic membrane” is not a claim limitation because
it appears in the preamble of the claims, and therefore no construction is necessary. Defendants
disagree, arguing that “macroscopic membrane” is a claim limitation that requires construction.
“Whether to treat a preamble as a limitation is a determination ‘resolved only on review
of the entire[ ] . . . patent to gain an understanding of what the inventors actually invented and
intended to encompass by the claim.’” Catalina Mktg. Int’l v. Coolsavings.com, Inc., 289 F.3d
801, 808 (Fed. Cir. 2002) (quoting Corning Glass Works v. Sumitomo Electric USA, Inc., 868
F.2d 1251, 1257 (Fed. Cir. 1989)). In general, “a preamble is not limiting ‘where a patentee
defines a structurally complete invention in the claim body and uses the preamble only to state a
purpose or intended use for the invention.’” Id. (quoting Rowe v. Dror, 112 F.3d 473, 478 (Fed.
Cir. 1997)). Conversely, “a preamble limits the invention if it recites essential structure or steps,
or if it is ‘necessary to give life, meaning, and vitality’ to the claim.” Id. (quoting Pitney Bowes
Inc. v. Hewlett-Packard Co., 182 F.3d 1298, 1305 (Fed. Cir. 1999)). “Moreover, clear reliance
on the preamble during prosecution to distinguish the claimed invention from the prior art
transforms the preamble into a claim limitation because such reliance indicates use of the
preamble to define, in part, the claimed invention.” Id. Compare Kropa v. Robie, 187 F.2d 150,
152 (Fed. Cir. 1951) (holding that preamble term “abrasive article” was “essential to point out
the invention defined by the counts”), with Aspex Eyewear, Inc. v. Marchon Eyewear, Inc., 672
13
F.3d 1335, 1347 (Fed. Cir. 2012) (concluding that preamble did not limit the claims where
“nothing in the prosecution history suggest[ed] that the preamble language was considered
necessary to the patentability of the claims”).
The term “macroscopic membrane” appears in the preamble of Claim 1 of the ’483 Patent
and the body of Claim 1 of the ’343 Patent. Thus, at least as to the ’343 Patent, “macroscopic
membrane” is a claim limitation. Moreover, the court agrees with Defendants that “macroscopic
membrane” is a claim limitation as to the ’483 Patent as well. Although the term appears in the
preamble of Claim 1 of the ’483 Patent, the patentees relied on the formation of a “macroscopic
membrane” to distinguish the invention from prior art. See Defs.’ Ex. C, 3DM 000628 [#43-6]
(“The most important distinction between the claimed invention and [Osterman et al.’s]
oligopeptide is that they did not observe macroscopic membrane formation although they noted
microscopic aggregation.”); id. at 3DM 000629 [#43-7] (“Gay et al. teach that a leucine rich
peptide produced by the Drosphila Toll gene will aggregate to form a gel, which is water soluble.
Gay et al. do not teach that any peptide capable of forming a β–sheet could be employed to
produce a stable macroscopic membrane, such as those claimed herein.”); id. at 3DM 000631
[#43-7]; see also ’483 Patent, col. 1, ll. 25-36 (“At present, the self-assembly of peptides into
macroscopic membranes has not been reported. . . . This invention relates to the self-assembly of
peptides into stable macroscopic membranes.”). Thus, the court concludes that “macroscopic
membrane” is a claim limitation for both patents.
Turning to the meaning of “macroscopic membrane,” the parties agree that
“macroscopic” should be given its plain and ordinary meaning, and further agree as to what that
plain and ordinary meaning is. See Defs.’ Opening Claim Constr. Br. 12 [#43]; see also Pls.’
Supp. Br. on Claim Constr. 7 [#55]. Accordingly, the court concludes that it need not construe
14
the term “macroscopic,” and that the plain and ordinary meaning of the term applies.
The parties’ dispute centers on the term “membrane.” Plaintiffs argue that, if the court
concludes that “membrane” is a claim limitation, then the court need not issue a claim
construction because the plain and ordinary meaning of the term applies. Alternatively,
Plaintiffs argue that, if the court decides to construe “membrane,” then the court should construe
it to mean a “material of interwoven filaments.” Defendants assert that the court’s construction
of the term “membrane” is required in order to resolve a dispute between the parties. Defendants
further assert that “membrane” should be defined as “a thin sheet or layer.”
A court may construe a claim term to have its plain and ordinary meaning when such a
construction resolves a dispute between the parties. See O2 Micro Int’l Ltd. v. Beyond
Innovation Tech. Co., 521 F.3d 1351, 1361 (Fed. Cir. 2008). However, “[a] determination that a
claim term ‘needs no construction’ or has the ‘plain and ordinary meaning’ may be inadequate
when a term has more than one ‘ordinary’ meaning or when reliance on a term’s ‘ordinary’
meaning does not resolve the parties’ dispute.” Id.; see also id. at 1360 (“When the parties raise
an actual dispute regarding the proper scope of these claims, the court, not the jury, must resolve
that dispute.”). Here, the parties raise an actual dispute as to the scope of the claim language.
Accordingly, the court finds that construction of the term “membrane” is necessary.
“Membrane” is a term that has a plain and ordinary meaning that is widely understood.
See, e.g., Defs.’ Ex. E [#43-11], Membrane, GRANT & HACKH’S CHEMICAL DICTIONARY (5th ed.
1987) (defining “membrane” as a “thin, enveloping or lining substance which divides a space or
an organ; . . . [a] tissue that permits the passage of certain substances, e.g., ions, but prevents the
passage of others, e.g., colloids”); Defs.’ Ex. F [#43-12], Membrane, AMERICAN HERITAGE
DICTIONARY (2d College ed. 1985) (defining “membrane” as “1. Biol. A thin, pliable layer of
15
tissue covering surfaces or separating or connecting regions of structures, or organs of an animal
or plant. . . . 3. Chem. A thin sheet of natural or synthetic material that is permeable to substances
in solution.”); Defs.’ Ex. G [#43-13], Kirk-Othmer, ENCYCLOPEDIA OF CHEMICAL TECHNOLOGY
vol. 16, p. 137 (4th ed. 1995) (“[A] membrane is a discrete, thin interface that moderates the
permeation of chemical species in contact with it.”). Defendants’ proposed construction is in
line with the plain and ordinary meaning of the term.
Based on the above, the ordinary meaning of “membrane” includes “a thin soft pliable
sheet or layer especially of animal or plant origin” and “a discrete, thin interface that moderates
permeation.” From these definitions, the court drops the phrases “soft pliable” and “especially of
animal or plant origin” because these phrases have no apparent relevance to this case and find no
support in the claims, specifications, or prosecution history. The court finds the remainder of the
ordinary meaning of “membrane” to be consistent with the specifications. See ’343 Patent, col.
2, ll. 17-21 (“The membranes are thin, transparent and resemble high density felt under high
magnification. . . . They . . . are permeable . . . .”); ’343 Patent, col. 3, l. 46 – col. 4, l. 2 (“The
EAK16 peptide was observed to form a membranous structure with the appearance of a piece of
transparent, thin . . . plastic membrane . . . . At low magnifications (50-100x), the structure looks
like a flat membrane. . . . The architecture of the structure appears to resemble high density felt
or cloth.”); ’343 Patent, col. 10, l. 66 – col. 11, l. 1 (“[The membranes] can be used in numerous
applications in which permeable and water insoluble material are appropriate . . . .”); ’483 Patent,
col. 2, ll. 11-15 (“[T]he macroscopic membranes provided by this invention are potentially useful
as biomaterial for medical products, as vehicles for slow-diffusion drug delivery, as separation
matrices, and for other uses requiring permeable and water-insoluble material.”); ’483 Patent,
col. 7, ll. 49-52 (“The membranes can be transferred from one solution to another using a solid
16
support such as a spatula. They can be broken by cutting, tearing or shearing.”).
Plaintiffs’ proposed construction appears to broaden the term “membrane” beyond its
plain and ordinary meaning to include all materials possessing interwoven filaments. Plaintiffs’
proposed broadening of the term, however, is not supported by the claim language, specification,
or prosecution history. Starting with the language of the claims, the court finds it significant
that, although the patentees used the terms “material” and “structure” at various points in the
specifications, the patentees chose to use the term “membrane” instead of “material” or
“structure” in the claims. See Medisim Ltd. v. BestMed LLC, No. 10 Civ. 2463, 2011 WL
2693896, at *6 (S.D.N.Y. July 8, 2011) (“I find it significant that the patent uses the word
‘membrane’ and therefore decline to substitute the word ‘material’ for ‘membrane.’”); Regents
of the Univ. of MN v. AGA Med. Corp., 660 F. Supp. 2d 1037, 1054 (D. Minn. 2009) (“[T]he
court construes the term ‘membrane’ . . . to mean ‘a thin sheet or layer of material’ . . . rather
than simply ‘material’ . . . .”).
Turning to the specifications, Plaintiffs’ argument that “membrane” should be defined as
a “material of interwoven filaments” is based on an excerpt from the ’483 specification. See
’483 Patent, col. 3, ll. 25-48 (“The EAK16 peptide was observed to form a membranous
structure with the appearance of a piece of transparent, thin (about 10-20 μm) plastic membrane .
. . . [A scanning electron microscope] revealed that the membrane is made up of individual
filaments that are interwoven.”). This passage is an excerpt from the specification discussing the
appearance of a preferred embodiment (EAK 16) when viewed through a microscope at a certain
magnification. There is no indication that the patentees intended this passage to redefine the
ordinary meaning of the term “membrane.” Nor does the passage suggest that the patentees
intended to claim all materials possessing interwoven filaments.
17
Finally, Plaintiffs’ proposed construction is in tension with the prosecution history. To
overcome an objection from the PTO, the patentees distinguished their claimed invention from
prior art involving materials that similarly could possess interwoven filaments but did not form
membranes. See Defs.’ Ex. C, 3DM 000628 [#43-6] (“The most important distinction between
the claimed invention and [Osterman et al.’s] oligopeptide is that they did not observe
macroscopic membrane formation although they noted microscopic aggregation.”); id. at 3DM
000629 [#43-7] (“Gay et al. teach that a leucine rich peptide produced by the Drosphila Toll
gene will aggregate to form a gel, which is water soluble. Gay et al. do not teach that any
peptide capable of forming a β–sheet could be employed to produce a stable macroscopic
membrane, such as those claimed herein.”); id. at 3DM 000630 (“The references further do not
teach membranes possessing the stability properties of the claimed membranes.”). The
patentees’ attempt to distinguish the claimed invention from these other materials suggests that
“membrane” likely requires something more than interwoven filaments.
The court is not persuaded that Plaintiffs’ broader construction is appropriate. See
Brookhill-Wilk 1, LLC v. Intuitive Surgical, Inc., 334 F.3d 1294, 1298 (Fed. Cir. 2003) (“In the
absence of an express intent to impart a novel meaning to the claim terms, the words are
presumed to take on the ordinary and customary meaning attributed to them by those of ordinary
skill in the art.”). The court therefore construes “membrane” in accordance with its plain and
ordinary meaning as “a thin sheet or layer that moderates permeation.”
E.
“alternating hydrophobic and hydrophilic amino acids”
The term “alternating hydrophobic and hydrophilic amino acids” appears throughout the
’483 and ’343 Patents. Its use in Claim 1 of the ’483 Patent is typical:
1. A macroscopic membrane which is formed by the self-assembly of amphiphilic
peptides in an aqueous solution containing monovalent metal cations, wherein the
18
peptides contain 12 or more amino acids, have alternating hydrophobic and
hydrophilic amino acids and are complementary and structurally compatible.
The parties’ proposed constructions of this term are as follows:
Disputed Term
Plaintiffs’ Construction
Defendants’ Construction
“alternating hydrophobic and
hydrophilic amino acids”
No construction necessary;
the plain and ordinary
meaning should apply.
“all the hydrophobic and
hydrophilic amino acids are
completely alternating, i.e. no
adjacent amino acids are both
hydrophobic or hydrophilic”
Plaintiffs contend that the term “alternating hydrophobic and hydrophilic amino acids”
needs no construction because the ordinary meaning of the term applies. Although Plaintiffs do
not explain what the ordinary meaning is, Plaintiffs would include mismatches, i.e. nonalternating amino acids. In contrast, Defendants argue that the patentees disavowed mismatches
during prosecution in order to overcome PTO enablement and prior-art objections. According to
Defendants, the prosecution history demonstrates that both the patentees and the PTO examiner
understood the limitation of “alternating hydrophobic and hydrophilic amino acids” to require a
completely alternating sequence.
The parties’ dispute boils down to whether the term “alternating hydrophobic and
hydrophilic amino acids” permits exceptions/mismatches, or whether the term requires a
completely alternating sequence. Because the parties dispute the scope of the claim term, the
court finds that construction of the term is necessary in order to resolve the dispute. See O2
Micro Int’l Ltd., 521 F.3d at 1361 (“A determination that a claim term ‘needs no construction’
or has the ‘plain and ordinary meaning’ may be inadequate when a term has more than one
‘ordinary’ meaning or when reliance on a term’s ‘ordinary’ meaning does not resolve the parties’
dispute.” Id.; see also id. at 1360-61 (holding that the district court erred in failing to construe
19
“only if” where the parties disputed whether the term allowed for exceptions).
Turning to the meaning of the term, Plaintiffs argue that the specification contains
language addressing mismatches, and that this language demonstrates that the patentees intended
the term “alternating” to include peptides with mismatches. In particular, Plaintiffs point to the
following passage:
Peptides, which are not perfectly complementary or structurally compatible, can
be thought of as containing mismatches analogous to mismatched base pairs in the
hybridization of nucleic acids. Peptides containing mismatches can form
membranes if the disruptive force of the mismatched pair is dominated by the
overall stability of the interpeptide interaction. Functionally, such peptides can
also be considered as complementary and structurally compatible. For example, a
mismatched amino acid pair may be tolerated if it is surrounded by several
perfectly matched pairs on each side. Mismatched peptides can be tested for
ability to self-assemble into macroscopic membranes using the methods described
herein.
’483 Patent, col. 6, ll. 12-24. This passage, however, relates to peptides that are not perfectly
complementary and structurally compatible, not to peptides that have mismatches in their
alternating amino acid sequence. Moreover, even if this passage could be read to relate to
peptides with mismatches in their alternating sequence, the court agrees with Defendants that the
patentees surrendered such mismatches at two points during the prosecution history.
“The prosecution history constitutes a public record of the patentee’s representations
concerning the scope and meaning of the claims, and competitors are entitled to rely on those
representations when ascertaining the degree of lawful conduct, such as designing around the
claimed invention.” Seachange Int’l, Inc. v. C-COR, Inc., 413 F.3d 1361, 1372 (Fed. Cir. 2005).
“[T]he prosecution history can often inform the meaning of the claim language by demonstrating
how the inventor understood the invention and whether the inventor limited the invention in the
course of the prosecution, making the claim scope narrower than it would otherwise be.”
Phillips, 415 F.3d at 1317. “Thus, in construing the claim, [the court] consider[s] the prosecution
20
history to determine whether the patentee disclaimed or disavowed subject matter, narrowing the
scope of the claim terms” through, for instance, “amendments to claims” or “arguments to
overcome and distinguish references.” Seachange Int’l, Inc., 413 F.3d at 1372 (internal
quotation marks and citations omitted).
First, the court finds that, although the patentees initially sought to include peptides with
mismatches in the patent, the patentees amended their claims and surrendered this goal in order
to overcome a PTO enablement objection. The patentees originally proposed Claim 1 as “A
macroscopic membrane which is formed by self-assembly of amphiphilic peptides in an aqueous
solution containing monovalent metal cations.” Defs.’ Ex. C, 3DM000255 [#43-4]. Although
the specifications described the preferred embodiments as having alternating hydrophobic and
hydrophilic amino acids, the claim language did not include the limitation that the amino acids
alternate. Additionally, the specifications included the above passage regarding mismatches.
The PTO rejected the patentees’ application based on enablement, stating: “the
specification states that peptides that do not meet the criteria required by Applicants’ model may
also form membranes. The specification does not, however, provide guidance regarding how
much deviation from the model would be expected to be tolerated before interfering with
membrane formation.” Defs.’ Ex. C, 3DM000660 [#43-7]; see also id. at 3DM000608 [#43-6]
(“[T]he specification provides inadequate guidance to enable the skilled artisan to make and use
the claimed invention with peptides comprising any combination of hydrophobic and hydrophilic
amino acids. . . . Undue experimentation would be required of the skilled artisan to determine
which of the myriad possible peptides encompassed by the instant claims would form
macroscopic membranes . . . .” (emphasis in original)).
In response to the PTO enablement objection, the patentees argued to the PTO that “with
21
rational experimentation design, the worker of skill in the art is enabled to design peptides which
deviate from the model and will form macroscopic membranes employing the teachings of the
specification as guidance.” Defs.’ Ex. C, 3DM000706 [#43-8]. The PTO again rejected the
patentees’ application on enablement grounds, and responded to the patentees by stating:
This argument is not deemed to be persuasive. Applicants have not pointed to
specific guidance in the specification which would enable a person or ordinary
skill in the art to practice the full scope of the claimed invention (i.e., to form
macroscopic membranes from peptides which do not meet the criteria disclosed
by the specification as essential to such membrane formation) without undue
experimentation.
Defs.’ Ex. C, 3DM000706 [#43-8].
In response to this rejection, the patentees decided to amend their claims to require
“alternating hydrophobic and hydrophilic amino acids,” instead of continuing to argue that the
claims should include mismatches (i.e. deviations from the model). Defs.’ Ex. C, 3DM00074850 [#43-8]. The PTO dropped its enablement objection and approved the patent with the added
limitations. The patentees’ decision to add the limitation that the peptides have “alternating
hydrophobic and hydrophilic amino acids” to overcome the PTO’s objection that the patent did
not “provide guidance regarding how much deviation from the model would be expected to be
tolerated,” suggests that the patentees did not understanding “alternating” to include deviations
and mismatches. Based on this prosecution history, the court is persuaded that the patentees
surrendered deviation/mismatches, and accordingly added the requirement for alternation, in
order to overcome the enablement objection.
Second, the court finds that the patentees disclaimed irregular sequences during the
prosecution in order to overcome a PTO prior-art objection. The prosecution history reflects that
the PTO initially rejected the patentees’ claims as obvious over prior art including Gay et al.,
whose peptides contain a sequence of ten alternating amino acids followed by a few non22
alternating and alternating pairs. See Defs.’ Ex. C, 3DM000610-11 [#43-6]; see also Markman
Tr. 74-75 [#53] (describing the Gay et al. peptide). In response to this objection, the patentees
argued to the PTO that their claimed peptides were distinguishable from Gay et al.’s peptides on
the ground that Gay et al.’s peptides “have irregular sequences.” See Defs.’ Ex. C, 3DM000630
[#43-7]. The patentees clarified that, in contrast to Gay et al.’s peptides, “[t]he claimed
membranes possess alternating hydrophilic and hydrophobic residues.” Id. The patentees’ act of
distinguishing their claimed “alternating” sequences from Gay et al.’s “irregular sequences”
served to narrow the scope of the patentees’ claims to regular sequences. See Seachange Int’l
Inc., 413 F.3d at 1373 (“[W]here an applicant argues that a claim possesses a feature that prior
art does not possess in order to overcome a prior art rejection, the argument may serve to narrow
the scope of the otherwise broad claim language.”); Ekchian v. Home Depot, Inc., 104 F.3d
1299, 1304 (Fed. Cir. 1997) (“[S]ince, by distinguishing the claimed invention over the prior art,
an applicant is indicating what the claims do not cover, he is by implication surrendering such
protection.”). 1 Thus, to the extent that “alternating” could be understood to include mismatches
or irregular sequences, the patentees surrendered such meaning.
The court also notes that in Plaintiffs’ opening and reply briefs, Plaintiffs made no
attempt to set forth a definition of “alternating” or to otherwise quantify how many mismatches a
peptide could possess and still be considered “alternating.” In response to the court’s concern,
Plaintiffs set forth a definition of “alternating hydrophobic and hydrophilic amino acids” in their
post-hearing brief as: “hydrophobic amino acid residues adjacent to hydrophilic amino acid
1
While the patentees argued before the PTO that the Gay et al. peptides were not “alternating”
but instead had “irregular sequences,” Plaintiffs now set forth an understanding of “alternating”
that Plaintiffs admit would include the Gay et al. peptides. See Markman Tr. 82-83 [#53].
23
residues with sufficient regularity to support stable β–sheet formation.” Pls.’ Supp. Br. 3 [#55].
In other words, Plaintiffs attempt to define the term as, and thus claim, any sequence that forms a
membrane, or “whatever works.” This, however, was the argument rejected by the PTO on
enablement grounds and that resulted in the patentees amending their claims to require
alternation.
For the above reasons, the court adopts the definition of “alternating hydrophobic and
hydrophilic amino acids” as “completely alternating hydrophobic and hydrophilic amino acids,
i.e. no adjacent amino acids are both hydrophobic or both hydrophilic.”
F.
“under conditions suitable for self-assembly of the peptide into the
macroscopic membrane”
The term “under conditions suitable for self-assembly of the peptide into the macroscopic
membrane” appears in Claim 37 of the ’483 Patent:
37. A method for forming a macroscopic membrane comprising forming an aqueous
mixture of peptides, which are 12 or more amino acids in length, have alternating
nonpolar and hydrophilic amino acids, and are complementary and structurally
compatible, and monovalent metal cations under conditions suitable for selfassembly of the peptide into the macroscopic membrane and allowing the
membrane to be formed.
The parties’ proposed constructions of this term are as follows:
Disputed Term
Plaintiffs’ Construction
Defendants’ Construction
“under conditions suitable for
self-assembly of the peptide
into the macroscopic
membrane”
No construction necessary;
the plain and ordinary
meaning applies.
Indefinite
Defendants argue that “if any of the above terms [in subsections A through E] are
construed as proposed by [Plaintiffs], the ‘conditions suitable’ limitation is indefinite.” Defs.’
Opening Claim Constr. Br. 25 [#43]. Defendants elaborate that “if the above disputed terms are
24
construed broader than the construction proposed by Defendants[,] one of ordinary skill in the art
would be unable to know the true limits of the ‘various’ conditions suitable . . . .” Id. at 23.
Defendants’ argument appears to conflate the “conditions suitable” term with other claim
limitations, suggesting that that the “conditions suitable for self-assembly” are that the peptides
have alternating hydrophobic and hydrophilic amino acids and are complementary, structurally
compatible, and amphiphilic. Defendants’ argument, however, renders claim language
redundant and the “conditions suitable” term superfluous. “[Courts] construe claims with an eye
toward giving effect to their terms.” Haemonetics Corp., 607 F.3d at 781; see also Merck & Co.,
395 F.3d at 1372 (“A claim construction that gives meaning to all the terms of the claim is
preferred over one that does not do so.”). The court therefore is not persuaded by Defendants’
argument that the “conditions suitable” term encompasses the other claim limitations.
Nevertheless, the question remains as to the meaning of the “conditions suitable” term, as
well as whether such term is indefinite. “[A] patent is invalid for indefiniteness if its claims,
read in light of the specification delineating the patent, and the prosecution history, fail to
inform, with reasonable certainty, those skilled in the art about the scope of the invention.”
Nautilus, Inc. v. Biosig Instruments, Inc., 134 S.Ct. 2120, 2124 (2014). “[T]he certainty which
the law requires in patents is not greater than is reasonable, having regard to their subjectmatter.” Id. at 2129 (quoting Minerals Separation, Ltd. v. Hyde, 242 U.S. 261, 270 (1916)).
Plaintiffs argue that the language of the claims and the specifications provide sufficient
guidance to inform a person skilled in the art about the scope of the claims. See, e.g., ’483
Patent, Claim 45 (“suitable conditions comprise the absence of an inhibitor”); ’483 Patent, Claim
48 (“suitable conditions comprise a pH of less than 12”); ’483 Patent, col. 6, ll. 54-57
(“Macroscopic membranes . . . appear after addition of sodium phosphate to a water-peptide
25
solution to an approximate final concentration of 100 mg/ml.”); ’483 Patent, col. 7, ll. 14-16
(“Concentrations of monovalent metal cations (NaCl) as low as 5 mM and as high as 5M have
been found to induce membrane formation within a few minutes.”); see also Interval Licensing
LLC v. AOL, Inc., 766 F.3d 1364, 1373 (Fed. Cir. 2014) (“We recognize that a patent which
defines a claim phrase through examples may satisfy the definiteness requirement.”).
The issues of indefiniteness and claim constructions are often “intimately related.” See
Manzo, Claim Construction in the Federal Circuit § 4.1 (2012 ed.); see also Praxair, Inc. v.
ATMI, Inc., 543 F.3d 1306, 1319 (Fed. Cir. 2008) (“[T]he same principles that generally govern
claim construction are applicable to determining whether allegedly indefinite claim language is
subject to construction.”). There are, however, some distinctions between claim construction and
indefiniteness. For instance, unlike claim construction, indefiniteness is a defense that the
allegedly infringing party must prove by “clear and convincing” evidence. Microsoft Corp. v. i4i
Ltd. P’ship, 131 S.Ct. 2238, 2242 (2011). Moreover, “unlike a Markman proceeding that gives
meaning to patent claims, indefiniteness invalidates the claims entirely.” CSB-Sys. Int’l Inc. v.
SAP Am., Inc., No. 10-2156, 2011 WL 3240838, at *18 (E.D. Pa. July 28, 2011). Accordingly,
courts have recognized that there are “reasons to defer ruling on indefiniteness until the summary
judgment stage.” Koninklijke Philips Elecs. v. Zoll Med. Corp., 914 F. Supp. 2d 89, 100 (D.
Mass. 2012). This is especially so if “the claim language itself is amenable to construction but is
alleged to be indefinite as applied.” Momenta Pharm., Inc. v. Amphastar Pharm., Inc., 887 F.
Supp. 2d 303, 313 (D. Mass. 2012); see also Takeda Pharm. Co. v. Handa Pharms., LLC, 2012
WL 1243109, at *16 (N.D. Cal. April 11, 2012) (deferring indefiniteness until summary
judgment because whether a person skilled in the art could determine relevant amounts without
undue experimentation was a “largely factual” inquiry).
26
Here, Defendants offer no argument apart from their argument discussed above
conflating the “conditions suitable” term with the other claim limitations. The court thus
concludes that the briefing and record are not sufficiently developed at this stage to decide the
question of indefiniteness. See Momenta Pharm., Inc., 887 F. Supp. 2d at 313 (“[Indefiniteness]
needs to be resolved, and will be, at a later point upon a complete record.”); Waddington N. Am.,
Inc. v. Sabert Corp., No. 09-4883, 2010 WL 4363137, at *3 (D.N.J. Oct. 27, 2010) (“[P]ractical
considerations . . . militate against determining indefiniteness prior to the end of fact or expert
discovery.”). Moreover, from what the court can glean from Defendants’ filing, Defendants’
indefiniteness challenge does not center on the meaning of the words in the “conditions suitable”
term. See Cipher Pharm. Inc. v. Actavis Labs. FL, Inc., 99 F. Supp. 3d 508, 514 (D.N.J. 2015)
(deferring ruling on indefiniteness where defendants’ indefiniteness argument “[did] not directly
implicate the construction of the word ‘about’” and “venture[d] far beyond the inherent meaning
of the words”). The court therefore declines to rule on indefiniteness at this stage.
V.
Conclusion
For the foregoing reasons, the claim terms are construed as follows:
1. The term “homogeneous” means “of the same character structure, quality, etc.;
essentially like; of the same nature.”
2. The term “amphiphilic peptides,” means “peptides that contain hydrophobic and
hydrophilic regions along their lengths.”
3. The term “complementary” means “the ability of peptides to interact through ionized
pairs or hydrogen bonds.”
4. The term “structurally compatible” means “the ability of complementary peptides to
maintain a constant distance between their peptide backbones.”
27
5. The term “membrane” means “a thin sheet or layer that moderates permeation.”
6. The term “alternating hydrophobic and hydrophilic amino acids” means “completely
alternating hydrophobic and hydrophilic amino acids, i.e. no adjacent amino acids are
both hydrophobic or both hydrophilic.”
IT IS SO ORDERED.
Date: January 11, 2016
/s/ Indira Talwani
United States District Judge
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