Actavis Laboratories UT, Inc. v. UCB, Inc.
Filing
70
MEMORANDUM OPINION AND ORDER. Signed by Magistrate Judge Roy S. Payne on 7/9/2016. (nkl, )
IN THE UNITED STATES DISTRICT COURT
FOR THE EASTERN DISTRICT OF TEXAS
MARSHALL DIVISION
ACTAVIS LABORATORIES UT, INC.,
Plaintiff,
v.
Case No. 2:15-cv-1001-JRG-RSP
UCB, INC.,
Defendant.
MEMORANDUM OPINION AND ORDER
Before the Court is the opening claim construction brief of Actavis Laboratories UT, Inc.
(“Plaintiff”) (Dkt. No. 46, filed on April 12, 2016), 1 the response of UCB, Inc. (“Defendant”) (Dkt.
No. 49, filed on April 26, 2016), and the reply of Plaintiff (Dkt. No. 51, filed on May 4, 2016). The
Court held a hearing on the issues of claim construction and claim definiteness on May 25, 2016.
Having considered the arguments and evidence presented by the parties at the hearing and in their
briefing, having considered the intrinsic evidence, and having made subsidiary factual findings
about the extrinsic evidence, the Court hereby issues this Claim Construction Memorandum
Opinion and Order. See Phillips v. AWH Corp., 415 F.3d 1303, 1314 (Fed. Cir. 2005); Teva
Pharm. USA, Inc. v. Sandoz, Inc., 135 S. Ct. 831, 841 (2015).
1
Citations to the parties’ filings are to the filing’s number in the docket (Dkt. No.) and pin cites
are to the page numbers assigned by ECF.
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Table of Contents
I.
BACKGROUND ............................................................................................................... 3
II.
LEGAL PRINCIPLES ..................................................................................................... 5
A.
Claim Construction ........................................................................................... 5
B.
Departing from the Ordinary Meaning of a Claim Term .................................. 7
C.
Functional Claiming and 35 U.S.C. § 112, ¶ 6 (pre-AIA) / § 112(f)
(AIA) ................................................................................................................. 9
D.
Definiteness Under 35 U.S.C. § 112, ¶ 2 (pre-AIA) / § 112(b) (AIA) ........... 11
III.
PERSON OF ORDINARY SKILL IN THE ART ....................................................... 12
IV.
CONSTRUCTION OF DISPUTED TERMS ............................................................... 13
A.
B.
The Spring Force/Adhesive Force Terms ....................................................... 19
C.
“resilient so as to return to a substantially flat orientation after being
bent out of the flat configuration” ................................................................... 25
D.
V.
The Flexible/Rigid Terms ............................................................................... 13
“the first and the second plies each being separable along the seal” .............. 28
CONCLUSION ............................................................................................................... 30
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I.
BACKGROUND
Plaintiff alleges infringement of U.S. Patent No. 7,921,999 (the “’999 Patent”). The ’999
Patent is entitled “Peelable Pouch For Transdermal Patch And Method For Packaging.” The
application leading to the ’999 Patent was filed on December 21, 2006 and the patent issued on
April 12, 2011. Through continuation-in-part and continuation applications, the ’999 Patent
claims priority to a provisional application filed on December 20, 2001.
In general, the ’999 Patent is directed to packaging for a transdermal patch. Specifically,
it is directed to packaging that addresses failings in the prior art related to: (1) tearing open the
packages to access the transdermal patch, and (2) adherence of the transdermal patch to the
packaging caused by leakage of the transdermal patch’s adhesive that is used to attach the patch
to the skin. ’999 Patent col.1 ll.28–50. According to the parties, this leakage of adhesive is
referred to as “cold flow.” (Dkt. No. 46 at 7; Dkt. No. 49 at 13). The ’999 Patent addresses these
failings with a peel-open packaging having certain characteristics that enable the patch that
adheres to the packaging to release from the packaging when the package is opened—the
peelable pouch system.
The ’999 Patent’s packaging can be generally understood with reference to Figures 3, 4A,
and 4B, reproduced here and
tabs
patch
annotated by the Court. These
figures depict a side view of the
pouch in various configurations:
Figure 3 depicts the pouch as
closed, Figure 4A depicts the
pouch as partially opened, and Figure 4B depicts the pouch as opened. The pouch includes plies
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(22, 24) that are sealed together to form a cavity. The patch (18, in yellow) is disposed within the
cavity. Portions of the plies are left unsealed, and form tabs (40, 42). The pouch is opened by
pulling the tabs apart, which separates the plies along the seal. If the patch adheres to one of the
plies due to cold flow of the patch’s adhesive, it will bend with the ply as the tab is pulled. But
because the patch is more rigid (i.e. less flexible) than the ply, it resists bending more so than the
ply and the patch will release from the ply without manipulation of the patch by the user.
Because the patch is resilient, it will return to its original un-bent form when released from the
ply.
The abstract of the ’999 Patent provides:
A peelable pouch comprises a substantially flat enclosure formed by first and
second opposing flexible plies. A seal extends along at least a portion of a
perimeter of the opposing plies. A flat, flexible transdermal patch is disposed in
the enclosure and includes a bioactive agent dissolved in a layer of adhesive. A
release liner is removably attached over the layer of adhesive, with the patch and
the release liner together being sufficiently resilient so as to generate a spring
force when displaced out of the flat configuration. The first and the second plies
each being separable along the seal and displaceable out of the flat configuration.
The spring force generated by the patch and the release liner being sufficient to
overcome an adhesive force created by the adhesive between the patch and one of
the plies.
Claims 1 and 14, the ’999 Patent’s independent claims, recite as follows:
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II.
LEGAL PRINCIPLES
A.
Claim Construction
“It is a ‘bedrock principle’ of patent law that ‘the claims of a patent define the invention
to which the patentee is entitled the right to exclude.’” Phillips v. AWH Corp., 415 F.3d 1303,
1312 (Fed. Cir. 2005) (en banc) (quoting Innova/Pure Water Inc. v. Safari Water Filtration Sys.,
Inc., 381 F.3d 1111, 1115 (Fed. Cir. 2004)). To determine the meaning of the claims, courts start
by considering the intrinsic evidence. Id. at 1313; C.R. Bard, Inc. v. U.S. Surgical Corp., 388
F.3d 858, 861 (Fed. Cir. 2004); Bell Atl. Network Servs., Inc. v. Covad Commc’ns Group, Inc.,
262 F.3d 1258, 1267 (Fed. Cir. 2001). The intrinsic evidence includes the claims themselves, the
specification, and the prosecution history. Phillips, 415 F.3d at 1314; C.R. Bard, Inc., 388 F.3d at
861. The general rule—subject to certain specific exceptions discussed infra—is that each claim
term is construed according to its ordinary and accustomed meaning as understood by one of
ordinary skill in the art at the time of the invention in the context of the patent. Phillips, 415 F.3d
at 1312–13; Alloc, Inc. v. Int’l Trade Comm’n, 342 F.3d 1361, 1368 (Fed. Cir. 2003); Azure
Networks, LLC v. CSR PLC, 771 F.3d 1336, 1347 (Fed. Cir. 2014) (“There is a heavy
presumption that claim terms carry their accustomed meaning in the relevant community at the
relevant time.”) (vacated on other grounds).
“The claim construction inquiry . . . begins and ends in all cases with the actual words of
the claim.” Renishaw PLC v. Marposs Societa’ per Azioni, 158 F.3d 1243, 1248 (Fed. Cir. 1998).
“[I]n all aspects of claim construction, ‘the name of the game is the claim.’” Apple Inc. v.
Motorola, Inc., 757 F.3d 1286, 1298 (Fed. Cir. 2014) (quoting In re Hiniker Co., 150 F.3d 1362,
1369 (Fed. Cir. 1998)). First, a term’s context in the asserted claim can be instructive. Phillips,
415 F.3d at 1314. Other asserted or unasserted claims can also aid in determining the claim’s
meaning, because claim terms are typically used consistently throughout the patent. Id.
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Differences among the claim terms can also assist in understanding a term’s meaning. Id. For
example, when a dependent claim adds a limitation to an independent claim, it is presumed that
the independent claim does not include the limitation. Id. at 1314–15.
“[C]laims ‘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) (en banc)).
“[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 (Fed. Cir. 1996)); Teleflex, Inc. v. Ficosa N. Am.
Corp., 299 F.3d 1313, 1325 (Fed. Cir. 2002). But, “‘[a]lthough the specification may aid the
court in interpreting the meaning of disputed claim language, particular embodiments and
examples appearing in the specification will not generally be read into the claims.’” Comark
Commc’ns, Inc. v. Harris Corp., 156 F.3d 1182, 1187 (Fed. Cir. 1998) (quoting Constant v.
Advanced Micro-Devices, Inc., 848 F.2d 1560, 1571 (Fed. Cir. 1988)); see also Phillips, 415
F.3d at 1323. “[I]t is improper to read limitations from a preferred embodiment described in the
specification—even if it is the only embodiment—into the claims absent a clear indication in the
intrinsic record that the patentee intended the claims to be so limited.” Liebel-Flarsheim Co. v.
Medrad, Inc., 358 F.3d 898, 913 (Fed. Cir. 2004).
The prosecution history is another tool to supply the proper context for claim
construction because, like the specification, the prosecution history provides evidence of how the
U.S. Patent and Trademark Office (“PTO”) and the inventor understood the patent. Phillips, 415
F.3d at 1317. However, “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. at
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1318; see also Athletic Alternatives, Inc. v. Prince Mfg., 73 F.3d 1573, 1580 (Fed. Cir. 1996)
(ambiguous prosecution history may be “unhelpful as an interpretive resource”).
Although extrinsic evidence can also be useful, it is “‘less significant than the intrinsic
record in determining the legally operative meaning of claim language.’” Phillips, 415 F.3d at
1317 (quoting C.R. Bard, Inc., 388 F.3d at 862). Technical dictionaries and treatises may help a
court understand the underlying technology and the manner in which one skilled in the art might
use claim terms, but technical dictionaries and treatises may provide definitions that are too
broad or may not be indicative of how the term is used in the patent. Id. at 1318. Similarly,
expert testimony may aid a court in understanding the underlying technology and determining
the particular meaning of a term in the pertinent field, but an expert’s conclusory, unsupported
assertions as to a term’s definition are entirely unhelpful to a court. Id. Generally, extrinsic
evidence is “less reliable than the patent and its prosecution history in determining how to read
claim terms.” Id. The Supreme Court recently explained the role of extrinsic evidence in claim
construction:
In some cases, however, the district court will need to look beyond the patent’s
intrinsic evidence and to consult extrinsic evidence in order to understand, for
example, the background science or the meaning of a term in the relevant art
during the relevant time period. See, e.g., Seymour v. Osborne, 11 Wall. 516, 546
(1871) (a patent may be “so interspersed with technical terms and terms of art that
the testimony of scientific witnesses is indispensable to a correct understanding of
its meaning”). In cases where those subsidiary facts are in dispute, courts will
need to make subsidiary factual findings about that extrinsic evidence. These are
the “evidentiary underpinnings” of claim construction that we discussed in
Markman, and this subsidiary factfinding must be reviewed for clear error on
appeal.
Teva Pharm. USA, Inc. v. Sandoz, Inc., 135 S. Ct. 831, 841 (2015).
B.
Departing from the Ordinary Meaning of a Claim Term
There are “only two exceptions to [the] general rule” that claim terms are construed
according to their plain and ordinary meaning: “1) when a patentee sets out a definition and acts
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as his own lexicographer, or 2) when the patentee disavows the full scope of the claim term
either in the specification or during prosecution.” 2 Golden Bridge Tech., Inc. v. Apple Inc., 758
F.3d 1362, 1365 (Fed. Cir. 2014) (quoting Thorner v. Sony Computer Entm’t Am. LLC, 669 F.3d
1362, 1365 (Fed. Cir. 2012)); see also GE Lighting Solutions, LLC v. AgiLight, Inc., 750 F.3d
1304, 1309 (Fed. Cir. 2014) (“[T]he specification and prosecution history only compel departure
from the plain meaning in two instances: lexicography and disavowal.”). The standards for
finding lexicography or disavowal are “exacting.” GE Lighting Solutions, 750 F.3d at 1309.
To act as his own lexicographer, the patentee must “clearly set forth a definition of the
disputed claim term,” and “clearly express an intent to define the term.” Id. (quoting Thorner,
669 F.3d at 1365); see also Renishaw, 158 F.3d at 1249. The patentee’s lexicography must
appear “with reasonable clarity, deliberateness, and precision.” Renishaw, 158 F.3d at 1249.
To disavow or disclaim the full scope of a claim term, the patentee’s statements in the
specification or prosecution history must amount to a “clear and unmistakable” surrender. Cordis
Corp. v. Boston Sci. Corp., 561 F.3d 1319, 1329 (Fed. Cir. 2009); see also Thorner, 669 F.3d at
1366 (“The patentee may demonstrate intent to deviate from the ordinary and accustomed
meaning of a claim term by including in the specification expressions of manifest exclusion or
restriction, representing a clear disavowal of claim scope.”) “Where an applicant’s statements are
amenable to multiple reasonable interpretations, they cannot be deemed clear and unmistakable.”
3M Innovative Props. Co. v. Tredegar Corp., 725 F.3d 1315, 1326 (Fed. Cir. 2013).
Although a statement of lexicography or disavowal must be exacting and clear, it need
not be “explicit.” See Trs. of Columbia Univ. v. Symantec Corp., 811 F.3d 1359, 1364 (Fed. Cir.
2
Some cases have characterized other principles of claim construction as “exceptions” to the
general rule, such as the statutory requirement that a means-plus-function term is construed to
cover the corresponding structure disclosed in the specification. See, e.g., CCS Fitness, Inc. v.
Brunswick Corp., 288 F.3d 1359, 1367 (Fed. Cir. 2002).
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2016) (“a patent applicant need not expressly state ‘my invention does not include X’ to indicate
his exclusion of X from the scope of his patent”). Lexicography or disavowal can be implied
where, e.g., the patentee makes clear statements characterizing the scope and purpose of the
invention. See On Demand Mach. Corp. v. Ingram Indus., Inc., 442 F.3d 1331, 1340 (Fed. Cir.
2006) (“[W]hen the scope of the invention is clearly stated in the specification, and is described
as the advantage and distinction of the invention, it is not necessary to disavow explicitly a
different scope.”). Nonetheless, the plain meaning governs “[a]bsent implied or explicit
lexicography or disavowal.” Trs. of Columbia Univ., 811 F.3d at 1364 n.2.
C.
Functional Claiming and 35 U.S.C. § 112, ¶ 6 (pre-AIA) / § 112(f) (AIA) 3
A patent claim may be expressed using functional language. See 35 U.S.C. § 112, ¶ 6;
Williamson v. Citrix Online, LLC, 792 F.3d 1339, 1347–49 & n.3 (Fed. Cir. 2015) (en banc in
relevant portion). Section 112, Paragraph 6, provides that a structure may be claimed as a “means
. . . for performing a specified function” and that an act may be claimed as a “step for performing
a specified function.” Masco Corp. v. United States, 303 F.3d 1316, 1326 (Fed. Cir. 2002).
But § 112, ¶ 6 does not apply to all functional claim language. There is a rebuttable
presumption that § 112, ¶ 6 applies when the claim language includes “means” or “step for”
terms, and that it does not apply in the absence of those terms. Masco Corp., 303 F.3d at 1326;
Williamson, 792 F.3d at 1348. The presumption stands or falls according to whether one of
ordinary skill in the art would understand the claim with the functional language, in the context
of the entire specification, to denote sufficiently definite structure or acts for performing the
function. See Media Rights Techs., Inc. v. Capital One Fin. Corp., 800 F.3d 1366, 1372 (Fed.
Cir. 2015) (§ 112, ¶ 6 does not apply when “the claim language, read in light of the specification,
3
Because the application resulting in the ’999 Patent was filed before September 16, 2012, the
effective date of the America Invents Act (“AIA”), the Court refers to the pre-AIA version of §
112.
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recites sufficiently definite structure” (quotation marks omitted) (citing Williamson, 792 F.3d at
1349; Robert Bosch, LLC v. Snap-On Inc., 769 F.3d 1094, 1099 (Fed. Cir. 2014))); Williamson,
792 F.3d at 1349 (§ 112, ¶ 6 does not apply when “the words of the claim are understood by
persons of ordinary skill in the art to have sufficiently definite meaning as the name for
structure”); Masco Corp., 303 F.3d at 1326 (§ 112, ¶ 6 does not apply when the claim includes
an “act” corresponding to “how the function is performed”); Personalized Media
Communications, L.L.C. v. International Trade Commission, 161 F.3d 696, 704 (Fed. Cir. 1998)
(§ 112, ¶ 6 does not apply when the claim includes “sufficient structure, material, or acts within
the claim itself to perform entirely the recited function . . . even if the claim uses the term
‘means.’” (quotation marks and citation omitted)).
When it applies, § 112, ¶ 6 limits the scope of the functional term “to only the structure,
materials, or acts described in the specification as corresponding to the claimed function and
equivalents thereof.” Williamson, 792 F.3d at 1347. Construing a means-plus-function limitation
involves multiple steps. “The first step . . . is a determination of the function of the means-plusfunction limitation.” Medtronic, Inc. v. Advanced Cardiovascular Sys., Inc., 248 F.3d 1303, 1311
(Fed. Cir. 2001). “[T]he next step is to determine the corresponding structure disclosed in the
specification and equivalents thereof.” Id. A “structure disclosed in the specification is
‘corresponding’ structure only if the specification or prosecution history clearly links or
associates that structure to the function recited in the claim.” Id. The focus of the “corresponding
structure” inquiry is not merely whether a structure is capable of performing the recited function,
but rather whether the corresponding structure is “clearly linked or associated with the [recited]
function.” Id. The corresponding structure “must include all structure that actually performs the
recited function.” Default Proof Credit Card Sys. v. Home Depot U.S.A., Inc., 412 F.3d 1291,
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1298 (Fed. Cir. 2005). However, § 112 does not permit “incorporation of structure from the
written description beyond that necessary to perform the claimed function.” Micro Chem., Inc. v.
Great Plains Chem. Co., 194 F.3d 1250, 1258 (Fed. Cir. 1999).
For § 112, ¶ 6 limitations implemented by a programmed general purpose computer or
microprocessor, the corresponding structure described in the patent specification must include an
algorithm for performing the function. WMS Gaming Inc. v. Int’l Game Tech., 184 F.3d 1339,
1349 (Fed. Cir. 1999). The corresponding structure is not a general purpose computer but rather
the special purpose computer programmed to perform the disclosed algorithm. Aristocrat Techs.
Austl. Pty Ltd. v. Int’l Game Tech., 521 F.3d 1328, 1333 (Fed. Cir. 2008).
D.
Definiteness Under 35 U.S.C. § 112, ¶ 2 (pre-AIA) / § 112(b) (AIA) 4
Patent claims must particularly point out and distinctly claim the subject matter regarded
as the invention. 35 U.S.C. § 112, ¶ 2. A claim, when viewed in light of the intrinsic evidence,
must “inform those skilled in the art about the scope of the invention with reasonable certainty.”
Nautilus Inc. v. Biosig Instruments, Inc., 134 S. Ct. 2120, 2129 (2014). If it does not, the claim
fails § 112, ¶ 2 and is therefore invalid as indefinite. Id. at 2124. Whether a claim is indefinite is
determined from the perspective of one of ordinary skill in the art as of the time the application
for the patent was filed. Id. at 2130. As it is a challenge to the validity of a patent, the failure of
any claim in suit to comply with § 112 must be shown by clear and convincing evidence. Id. at
2130 n.10. “[I]ndefiniteness is a question of law and in effect part of claim construction.” ePlus,
Inc. v. Lawson Software, Inc., 700 F.3d 509, 517 (Fed. Cir. 2012).
When a term of degree is used in a claim, “the court must determine whether the patent
provides some standard for measuring that degree.” Biosig Instruments, Inc. v. Nautilus, Inc.,
4
Because the application resulting in the ’999 Patent was filed before September 16, 2012, the
effective date of the America Invents Act (“AIA”), the Court refers to the pre-AIA version of §
112.
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783 F.3d 1374, 1378 (Fed. Cir. 2015) (quotation marks omitted). Likewise, when a subjective
term is used in a claim, “the court must determine whether the patent’s specification supplies
some standard for measuring the scope of the [term].” Datamize, LLC v. Plumtree Software, Inc.,
417 F.3d 1342, 1351 (Fed. Cir. 2005); accord Interval Licensing LLC v. AOL, Inc., 766 F.3d
1364, 1371 (Fed. Cir. 2014) (citing Datamize, 417 F.3d at 1351).
In the context of a claim governed by 35 U.S.C. § 112, ¶ 6, the claim is invalid as
indefinite if the claim fails to disclose adequate corresponding structure to perform the claimed
functions. Williamson, 792 F.3d at 1351–52. The disclosure is inadequate when one of ordinary
skill in the art “would be unable to recognize the structure in the specification and associate it
with the corresponding function in the claim.” Id. at 1352.
III.
PERSON OF ORDINARY SKILL IN THE ART
Defendant posits that one of ordinary skill in the relevant art is: “a person with a Ph.D.
degree or the equivalent work experience in a field relating to polymer sciences as well as
several years of experience designing or developing transdermal delivery systems.” (Dkt. No. 49
at 14 n.3); (Declaration of David J. Enscore, Ph.D (“Enscore Decl.”) ¶ 26, Dkt. No. 49-6 at 7–8).
Plaintiff disagrees with Defendant’s characterization of one of ordinary skill in the art,
and posits that artisan is: “a person with a master’s degree in mechanical engineering or
packaging, or equivalent professional experience, as well as at least two years of experience in
the design and use of packaging for transdermal patches or other medical devices or
pharmaceuticals.” (Dkt. No. 51 at 5–6); (Declaration of J. Paul Singh, Ph.D (“Singh Decl.”) ¶¶
25–28, Dkt. No. 51-2 at 6–7). Plaintiff contends that Defendant’s representation of one of
ordinary skill in the art is flawed because it is based on an incorrect view of the art. (Dkt. No. 51
at 5); (Singh Decl. ¶¶ 26–27, Dkt. No. 51-2 at 7). Plaintiff contends that the art is transdermal-
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patch packaging, not transdermal delivery systems or polymer science. (Dkt. No. 51 at 5); (Singh
Decl. ¶¶ 26–27, Dkt. No. 51-2 at 7).
The Court tends to agree with Plaintiff. The ’999 Patent states the field of the invention
as: “peelable pouches for storage of transdermal patches, and methods for packaging objects or
transdermal patches.” ’999 Patent col.1 ll.15–17. This is packaging, not delivery. As such, it is
unlikely that one of skill in the art requires specialized knowledge in polymers or transdermal
drug delivery.
However, the Court determines that the dispute is moot. The Court’s findings and
holdings regarding the claim construction disputes between the parties are the same whether it
applies Plaintiff’s or Defendant’s proposed definition of one of skill in the art. 5 The Court
therefore declines to rule on this dispute at this time.
IV.
CONSTRUCTION OF DISPUTED TERMS
The parties’ positions and the Court’s analysis as to the disputed terms are presented
below.
A.
The Flexible/Rigid Terms
Disputed Term 6
“flexible”
•
Defendant’s Proposed
Construction
Indefinite.
Plain and ordinary meaning.
Indefinite.
’999 Patent Claims 1, 14
“relatively more rigid”
•
Plaintiff’s Proposed
Construction
Plain and ordinary meaning.
’999 Patent Claims 2, 16
5
Moreover, this is likely a fact question for the jury. Cf. MobileMedia Ideas LLC v. Apple Inc.,
780 F.3d 1159, 1167 (Fed. Cir. 2015) (in the context of obviousness, “the level of ordinary skill
in the field of the invention” is a jury fact question reviewed for substantial evidence).
6
For all term charts in this Order, the claims in which the term is found are listed with the term
but: (1) only the highest level claim in each dependency chain is listed, and (2) only asserted
claims identified in the Parties’ Joint Claim Construction Chart (Dkt. No. 52) are listed.
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Disputed Term 6
“rigid so as to at least
partially resist bending”
•
Plaintiff’s Proposed
Construction
Plain and ordinary meaning.
Defendant’s Proposed
Construction
Indefinite.
’999 Patent Claim 14
Because the parties’ arguments and proposed constructions with respect to these terms
are related, the Court addresses the terms together.
The Parties’ Positions
Plaintiff submits that “flexible” is used in the patent to denote that something may be
bent without breaking, as per the term’s ordinary meaning. (Dkt. No. 46 at 14). Plaintiff further
submits that the patent allows that something may be simultaneously “flexible” and “rigid” and
“resilient” in that flexible material, while bendable, may resist the bend and return to its unbent
position when no longer being bent. (Id. at 14–15) (citing U.S. Patent App. No. 10/321,405 7 (the
“’405 App.”) File Wrapper April 2, 2004 Response/Amendment at 9, Dkt. No. 46-4 at 4).
Plaintiff submits that “relatively more rigid” is not indefinite because “rigid,” as used in
the patent, does not mean absolutely inflexible—it is used in the patent to denote that materials
have degrees of rigidity. (Id. at 15–16). For example, the patent teaches there is a “difference in
rigidity between the patch and the ply.” (Id. at 16) (quoting ’999 Patent col.10 ll.12–15). And,
Plaintiff submits, the claim language provides the measure of “relative” in that it states “the
release liner of the patch is relatively more rigid than the remaining portions of the patch.” (Id.).
According to Plaintiff, this means that “the rigidity of the release liner of the patch is measured
relative to the rigidity of the remaining portions of the patch.” (Id. at 16–17).
7
The ’999 Patent claims priority to the ’405 application. ’999 Patent at [63] Related U.S.
Application Data.
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Plaintiff submits that “rigid so as to a least partially resist bending” is readily understood
in the context of the patent’s teaching regarding the rigidity of the patch causing “a restoring
spring force” when the patch is bent. (Id. at 17) (quoting ’999 Patent col.10 ll.12–19).
In addition to the claims themselves, Plaintiff cites the following intrinsic and extrinsic
evidence to support its position. Intrinsic evidence: ’999 Patent col.9 ll.3–5, col.9 ll.56–62,
col.10 ll.12–19, figs. 4A, 4B; ’405 App. File Wrapper April 2, 2004 Response/Amendment
(excerpts) (Plaintiff’s Ex. D, Dkt. No. 46-4). Extrinsic evidence: Random House Dictionary of
the English Language (1987) “flexible” (Plaintiff’s Ex. C, Dkt. No. 46-3).
Defendant responds that it is impossible for a material to be simultaneously “flexible”
and “rigid” and that, therefore, the claims of the ’999 Patent are indefinite because they call for a
patch that is both flexible and rigid. (Dkt. No. 49 at 19–20). This, according to Defendant, is
because “rigid” is the antonym of “flexible.” (Id.). Defendant further responds that the patent
does not provide any guidance as to how the patch could be both flexible and rigid. (Id. at 20–
21). Defendant contends that the patent’s discussion of the patch being “flexible” to conform to
the contours of the user’s body is inapposite because the patch in the package is not the same
patch that is on the skin, the packaged patch includes a release liner. (Id. at 20–21). Further,
Defendant contends that the patent’s discussion of the patch’s ability to return to its original form
after being bent does not provide any metric to determine a degree of rigidity but rather pertains
to the patch’s resilience. (Id. at 21). And, according to Defendant, in the prosecution of the ’999
Patent, the patent examiner previously found that rigidity defined by its sufficiency to return the
patch to it pre-bend form is indefinite—and that finding occurred under a less-stringent preNautilus standard. (Id. at 21–22).
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With respect to “relatively more rigid,” Defendant responds that the relative nature of the
rigidity here exacerbates the flexible/rigid indefiniteness issue because the meaning of “relative”
is uncertain as a term of degree and because it is unclear whether the release liner is “relatively
more rigid” than the remaining portions of the patch separately or together, or to one or both of
the remaining portions. (Id. at 22–23).
With respect to “rigid so as to at least partially resist bending,” Defendant responds that
“[v]irtually every material can be said to resist bending to some extent depending on the
circumstances” and the patent fails to provide any guidance as to what level of resistance
satisfies the claim language. (Id. at 23) (citing Enscore Decl. ¶ 45, Dkt. No.49-6 at 12).
Defendant further responds that the term “partially” is subjective, and therefore indefinite. (Id. at
24). Defendant argues that determining whether a material is “rigid so as to at least partially
resist bending” based on the material’s tendency to return to is pre-bend configuration
improperly conflates two claim terms, “rigid” and “resilient.” (Id. at 24–25). And Defendant
argues that determining whether a material is “rigid so as to at least partially resist bending”
based on the “restoring spring force” generated by the material when bent improperly renders
Claim 15 superfluous. (Id. at 25–26).
In addition to the claims themselves, Defendant cites the following intrinsic and extrinsic
evidence to support its position. Intrinsic evidence: ’999 Patent col.10 ll.6–19, fig.6; ’999 Patent
File Wrapper Jan. 20, 2010 Response to Restriction Requirement (Defendant’s Ex. E, Dkt. No.
49-5), May 27, 2010 Office Action (Defendant’s Ex. A, Dkt. No. 49-1), Oct. 27, 2010
Amendment (Defendant’s Ex. C, Dkt. No. 49-3). Extrinsic evidence: Merriam Webster’s
Collegiate Thesaurus (1993) “rigid” (Defendant’s Ex. D, Dkt. No. 49-4); Enscore Decl. (Dkt.
- 16 -
No. 49-6); Random House Dictionary of the English Language (1987) “flexible” (Plaintiff’s Ex.
C, Dkt. No. 46-3).
Plaintiff replies that that the claims themselves provide the standard by which to
determine whether a patch is both “flexible” and “rigid.” (Dkt. No. 51 at 8–10). With respect to
Claims 2 and16, Plaintiff contends they recite a simple comparison of the rigidity of different
materials—which is readily done by comparing the materials’ “deformation in response to
loading or strain.” (Id. at 9) (citing Singh Decl. ¶ 40, Dkt. No. 51-2 at 11). With respect to Claim
14, Plaintiff contends that the “rigid” and “resilient” properties work together to define that the
patch partially resists bending with the plies and returns to a substantially flat form after bending
with the plies. (Id. at 9–10) (citing Singh Decl. ¶ 39, Dkt. No. 51-2 at 10).
Plaintiff cites further extrinsic evidence to support its position: Singh Decl. (Dkt. No. 512).
Analysis
The dispute essentially revolves around the meaning of “rigid.” The Court understands
“rigid,” as it is used in the ’999 Patent, to denote something that is resistant to flexing—it is not
used to denote something that is necessarily absolutely inflexible. Given this understanding of
“rigid,” Defendant has failed prove that any claim is indefinite because of the Flexible/Rigid
terms.
The Court understands that “rigid” and “rigidity” are used in the ’999 Patent to denote the
ease with which a flexible object may be bent. As Plaintiff contends, something is “flexible” if it
can bend without breaking. Defendant does not dispute this. But not everything that is flexible is
as easily bent. See, e.g., Random House Dictionary of the English Language (1987), (Dkt. No.
46-3 at 3) (noting a difference between “flexible” and its synonyms based on the “ease in
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bending”). That is, some flexible things are more easily bent than are other flexible things. Put
another way, some flexible things resist bending more than do other flexible things. The patent
expresses this ease-of-bending concept as “rigidity.” See, e.g., ’999 Patent col.9 ll.51–67 (noting
that “the plies 22, 24 can be more flexible (or more easily bent) than the patch by itself” and that
plies bend “in a direction along the plane of the patch 18 where the patch is most rigid”
(emphasis added)); col.10 ll.12–13 (noting “the difference in rigidity between the patch and the
ply” (emphasis added)); col.10 ll.21–24 (noting that the material of the patch “is selected to
provide sufficient rigidity” (emphasis added)).
That the patent is not using “rigid” in the sense of absolutely inflexible is also apparent
from a plain reading of the claims. For example, Claim 2 recites that the “release liner is
relatively more rigid than remaining portions of the patch.” Here, the term “relatively” clarifies
that the claim is not referring to absolute rigidity. The rest of the term describes that the release
liner is less flexible than what remains of the patch once the “removable release liner” is
removed. Similarly, Claim 14 recites “the patch being rigid so as to at least partially resist
bending.” The Court finds that “partially” here is not a subjective term as Defendant contends.
Rather, “so as to at least partially resist bending” provides guidance as to the patch’s rigidity.
The plain meaning of “the patch being rigid so as to at least partially resist bending” in the
context of the claim is that while the patch can be bent—i.e., it is not inflexible—it resists the
bending. And while this limitation may, as Defendant contends, be broad, breadth is not
indefiniteness.
Accordingly, the Court determines that “flexible” has its plain and ordinary meaning and
construes “relatively more rigid” and “rigid so as to a least partially resist bending” as follows:
•
“relatively more rigid” means “more resistant to bending”; and
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•
“rigid so as to at least partially resist bending” means “at least partially resistant to
bending.”
B.
The Spring Force/Adhesive Force Terms
Disputed Term
“resilient so as to generate a
spring force when displaced
out of the flat configuration
sufficient to overcome an
adhesive force between the
patch and one of the plies
created by the adhesive
layer leaking an adhesive
onto one of the plies”
•
Defendant’s Proposed
Construction
Indefinite.
Plain and ordinary meaning.
Indefinite.
’999 Patent Claim 1
“the patch generates a
spring force when bent out
of the flat configuration, the
spring force being sufficient
to overcome an adhesive
force between the patch and
one of the plies created by a
portion of the adhesive”
•
Plaintiff’s Proposed
Construction
Plain and ordinary meaning.
’999 Patent Claim 15
Because the parties’ arguments and proposed constructions with respect to these terms
are related, the Court addresses the terms together.
The Parties’ Positions
Plaintiff submits that these limitations are directed to the “element of the invention that
allows the patch to become unstuck from the plies of the pouch.” (Dkt. No. 46 at 21). The patent
explains that because the patch’s adhesive may escape from the patch, the patch “may adhere to
the interior of the [pouch]” and thereby make it difficult to retrieve the patch from the pouch. (Id.
at 21–22) (quoting ’999 Patent col.8 ll.24–32). Thus, if the patch adheres to a ply, it will bend
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along with the ply when the pouch is opened. (Id. at 22) (citing ’999 Patent col.10 ll.9–12,
fig.4A). In response to this bending, the patch will generate a spring force that is directed
opposite the bending and that is sufficient to overcome the adhesive force, and the patch will
“peel away from the ply” to which it adhered. (Id. at 22) (quoting ’999 Patent col.10 ll.12–19).
According to Plaintiff, the adhesive force that must be overcome is a function of various factors
the contribute to the leakage of adhesive—but these factors are known to those of ordinary skill
in the art such that they know “the range of sticking to expect under normal shipping and
handling conditions based on industry standards.” (Id. at 23).
In addition to the claims themselves, Plaintiff cites the following intrinsic evidence to
support its position: ’999 Patent col.8 ll.24–49, col.9 ll.52–56, col.10 ll.9–28, figs.4A, 4B.
Defendant responds that the “adhesive force” by which the patch is bound to a ply varies
considerably in practice and nothing in the patent provides guidance as to how and when to
determine the force. (Dkt. No. 49 at 13–14). Defendant argues that a given patch may at one time
not adhere to a ply (and therefore be outside the scope of the claims), at a later time be bound to
a ply because of intervening leakage of adhesive (cold flow) but with an adhesive force lower
than the spring force (and therefore potentially within the scope of the claims), and at a yet later
time and with more intervening leakage of adhesive be bound to a ply with an adhesive force
greater than the spring force (and therefore be outside the scope of the claims). (Id. at 14–15).
Thus, Defendant concludes, there is no standard by which to analyze whether a patch is within
the scope of the claims. (Id. at 15).
Defendant further responds that a standard by which the spring force is sufficient to
overcome the adhesive force in “an acceptable percentage of transdermal systems” based on “a
range of sticking to expect under normal shipping and handling conditions based on industry
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standards” is untenable. (Id. at 15–16) (quoting Plaintiff’s Brief, Dkt. No. 46 at 23). Defendant
contends that such a standard is improperly vague at least with respect to the “range of sticking,”
“normal shipping and handling conditions,” “industry standards,” and “acceptable percentage.”
(Id. at 16–17).
Defendant also responds that Claims 1 and 15 are indefinite because they are apparatus
claims that include methods steps. (Id. at 17–18). Specifically, Defendant contends that because
the only way to determine whether the spring force is sufficient to overcome the adhesive force
is to displace or bend the patch, Claim 1 requires the user to “conduct the step of displacing the
patch” and Claim 15 requires the user to “bend the patch.” (Id. at 18).
In addition to the claims themselves, Defendant cites the following intrinsic and extrinsic
evidence to support its position. Intrinsic evidence: ’999 File wrapper Oct. 27, 2010
Amendment (Defendant’s Ex. C, Dkt. No. 49-3). Extrinsic evidence: Enscore Decl. (Dkt. No.
49-6).
Plaintiff replies that the pouch system claimed in the ’999 Patent has recited properties
that result in it functioning in a certain way under certain conditions—the claims do not require
that those conditions exist at all times, or ever. (Dkt. No. 51 at 6–7). And the claims do not
require that the pouch actually perform the function it is capable of performing. (Id. at 8).
Specifically, the claims do not require that the adhesive actually leak from the patch to bind the
patch to a ply. (Id.). Rather, the claims require that if the adhesive leaks from the patch to bind
the patch to a ply, the pouch system has the recited properties that would release the patch from
the ply when the pouch is opened. (Id.). According to Plaintiff, the adhesive and spring forces of
the claims are a function of factors “routinely addressed when designing and testing packaged
products.” (Id. at 7–8) (citing Singh Decl. § III.D.2, Dkt. No. 51-2 at 10–11). That is, the pouch
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system properties are such that it “will work across the range conditions expected and specified
for the product.” (Id. at 3–4) (citing Singh Decl. ¶ 19, Dkt. No. 51-2 at 5).
Plaintiff cites further extrinsic evidence to support its position: Singh Decl. (Dkt. No. 512).
Analysis
There are two disputes with respect to these terms. First, whether it is reasonably certain
what it means for the “spring force . . . sufficient to overcome an adhesive force between the
patch and one of the plies.” And second, whether the apparatus claims require the user to
displace or bend the patch. As to the first, the Court determines that the meaning of the claim
language is reasonably certain. As to the second, the Court determines that the claims are
directed to capability, and do not require any act by the user. Defendant has failed prove that any
claim is indefinite because of the Spring Force/Adhesive Force terms.
The plain meaning of “spring force being sufficient to overcome an adhesive force
between the patch and one of the plies” is apparent from the words of the claim. The spring force
is stronger than the adhesive force between the patch and one of the plies such that the bond
between the patch and ply is broken by the spring force.
The patent provides further guidance regarding the degrees of spring force and adhesive
force contemplated. Specifically, the patent describes that the spring force is of such a degree so
as to overcome the adhesive force and spring free of the ply when the pouch holding the patch is
opened. See, e.g., ’999 Patent col.10 ll.15–19 (“The spring force is sufficient to cause the patch
(together with the liner) to peel away from the ply (that is being held by fingers of the user),
resulting in the patch being presented, in a ‘free’ state, for removal by the user from between the
plies.”). Further, the patent describes that the adhesive force is due to the adhesive on the
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transdermal patch—a special adhesive used to bond the patch to the skin so as to deliver the drug
through the skin. See, e.g., id. at col.4 ll.15–18 (defining “transdermal patch” as a “delivery
device which is used to transdermally deliver defined doses of a substance”), col.7 ll.23–62
(describing the “adhesive” as a “pharmaceutically acceptable carrier” and describing various
acceptable carrier materials), col.8 ll.24–48 (describing that “a minimal amount of the adhesive
[may] escape . . . [and] cause the patch to adhere to the interior of the packaging”); see also, ’999
Patent File Wrapper Oct. 27, 2010 Amendment at 9–10, (Dkt. No. 46-2 at 10–11) (noting that
“when matrix patches are stored in pouches, some of the adhesive from the adhesive layer may
leak or seep out onto the pouch. Therefore, when the pouch is opened, the matrix patch is
adhered to the pouch.”). That is, the spring force is meant to overcome the adhesive force a user
might experience when attempting to extract the patch from the pouch, not just any adhesive
force. In the context of the patent, the Court understands that what a user might experience is a
function of the storage and shipping conditions of the packaged transdermal patch—and the
Court finds that it is reasonably certain that these conditions are the prescribed conditions of the
packaged product. Singh Decl. ¶¶ 15–22, (Dkt. No. 51-2 at 6–8). Thus, the spring force is
sufficient to overcome the adhesive force that might occur under this prescribed range of storage
and shipping conditions. Whether a particular transdermal patch package satisfies these
limitations is an issue of infringement, not of claim construction.
Further, the Court understands that terms are directed to capabilities of the pouch, rather
than an actual use of the pouch. That is, the pouch is defined in part by the function it would
perform under specific conditions—its capability. This is an acceptable patent claim structure.
UltimatePointer, L.L.C. v. Nintendo Co., 816 F.3d 816, 826 (Fed. Cir. 2016). The Federal Circuit
recently reiterated in UltimatePointer that “[i]f an apparatus claim ‘is clearly limited to a[n
- 23 -
apparatus] possessing the recited structure and capable of performing the recited functions,’ then
the claim is not invalid as indefinite.” Id. (quoting Microprocessor Enhancement Corp. v. Texas
Instruments Inc., 520 F.3d 1367, 1375 (Fed. Cir. 2008)) (emphasis in original). Microprocessor
Enhancement is instructive. The limitation at issue there is “the conditional execution decision
logic pipeline stage, when specified by the conditional execution specifier, determining the
enable-write using the boolean algebraic evaluation.” Microprocessor Enhancement, 520 F.3d at
1371–72, 1375. That is, the Microprocessor Enhancement claim is directed to a particular
structure (the “conditional execution decision logic pipeline stage”) that performs a certain
function (“determining the enable-write using the boolean algebraic evaluation”) when a
particular condition is met (“when specified by the conditional execution specifier”). Id. The
Federal Circuit held that such a limitation is directed to the capability of a structure. The
limitation was not directed to a step of performing the function or the particular condition in
which the function is performed. Id. Thus the claim was not indefinite. Id. The claim language at
issue here, taken in the context of the claim, is likewise directed to the capability of a structure—
it is directed to the patch’s ability to generate a spring force to overcome an adhesive force in
certain conditions.
Accordingly, the Court holds that these terms do not render any claim indefinite and
determines that they have their plain and ordinary meaning and need no further construction.
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C.
“resilient so as to return to a substantially flat orientation after being bent
out of the flat configuration”
Disputed Term
“resilient so as to return to a
substantially flat orientation
after being bent out of the
flat configuration”
•
Plaintiff’s Proposed
Construction
Plain and ordinary meaning.
Defendant’s Proposed
Construction
Indefinite.
’999 Patent Claim 14
The Parties’ Positions
Plaintiff submits that, in the patent, a material is “resilient” when it develops a spring
force in opposition to any bending of the material, such as to restore the material to its unbent
position. (Dkt. No. 46 at 19) (citing ’405 App. File Wrapper at 9 (Dkt. No. 46-4 at 4)). Plaintiff
further submits that “substantially flat orientation” is understood in the context of the patent’s
teaching regarding the term “substantially.” (Id. at 19–20). Specifically, the patent explains that
“substantially” “refers to the complete or nearly complete extent” of a property such that effect
of the property is the “same overall result as if absolute and total completion were obtained.”
(Id.) (quoting ’999 Patent col.5 ll.45–54). According to Plaintiff, the patent teaches that patch is
“bent out of the flat configuration” when it is bent “along with the ply” when the pouch is
opened by the use. (Id.) (quoting ’999 Patent col.10 ll.9–12).
In addition to the claims themselves, Plaintiff cites the following intrinsic evidence to
support its position: ’999 Patent col.5 ll.45–54, col.10 ll.9–12, figs.4A, 4B; ’405 App. File
Wrapper April 2, 2004 Response/Amendment (excerpts) (Plaintiff’s Ex. D, Dkt. No. 46-4).
Defendant responds that the scope of this term is indefinite for two reasons: First, it is
unclear whether the patch must return to its substantially flat orientation regardless of how much
it is bent or whether a patch that returns to substantially flat orientation after a small bend but not
- 25 -
after a large bend would satisfy the claims. (Dkt. No. 49 at 26). Second, it is unclear what level
of flatness constitutes “substantially flat.” (Id. at 27–28).
Defendant also responds that Claim 14 is indefinite because it is an apparatus claim that
includes methods steps. (Id. at 28). According to Defendant, to determine whether something
falls within the scope of the claim, the patch must actually be bent and thus the claim includes a
bending step. (Id.)
In addition to the claims themselves, Defendant cites the following intrinsic and extrinsic
evidence to support its position. Intrinsic evidence: ’999 Patent col.5 ll.45–54. Extrinsic
evidence: Enscore Decl. (Dkt. No. 49-6).
Plaintiff replies that the recited “bent out of the flat configuration” is the bending of the
patch that occurs when the plies are bent if the patch adheres to a ply. (Dkt. No. 51 at 10).
Plaintiff notes that the recited “enclosure” that houses the patch is “substantially flat,” and that
Defendant does not contend that the “enclosure” term is indefinite. (Id.). Plaintiff contends that
one of ordinary skill in the art would understand that the pouch and patch need not be perfectly
flat. (Id.). Finally, Plaintiff argues as it did for the “spring force” and “adhesive force”
limitations—the claims are directed to features of the pouch system, not to steps for operating the
system. (Id.).
Plaintiff cites further extrinsic evidence to support its position: Singh Decl. (Dkt. No. 512).
Analysis
The dispute over this term involves three issues. First, whether the meaning of
“substantially flat” is reasonably certain. Second, whether it is reasonably certain how much
bending the patch can experience and still be resilient. And third, whether the term incorporates a
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method step into an apparatus claim. As to the first, the ’999 Patent’s guidance regarding the
packaging and shipping benefits of a flat patch renders the meaning of “substantially flat”
reasonably certain. As to the second, the bending that the patch must be able to return from is the
bending due to the peeling of the ply to which the patch adheres. As to the third, the term is
directed to a capability of the patch, not to an action.
A patch is “substantially flat” when it is flat enough to have the same overall effect on
space for packaging and shipping as it does in its original flat configuration. “Substantially flat”
is a term of degree that is sufficiently explained in the ’999 Patent. The patent describes that
“[t]he transdermal patch 18 preferably is flexible to conform to the contours of the user’s body or
skin, but initially is flat to reduce space for packaging and shipping.” col.9 ll.3–5 (emphasis
added). As relevant to this term, the patent also explains that “substantially” is used to denote a
characteristic or property that, while not complete, has the “same overall result” as if complete.
Id. at col.5 ll.45–54. Thus, the purpose of the patch’s initial flatness is to reduce space for
packaging and shipping and it is substantially flat if it has the same overall result as its initial
flatness with respect to packaging and shipping.
In the context of the patent’s description and claim set, the bending of Claim 15 refers to
the bending a patch adhered to a ply experiences when the plies of the pouch are peeled apart.
The claimed “resilient” is a term of degree that is defined by a bending that is sufficiently
explained in the ’999 Patent. The patent explains that the patch “is resilient enough to develop a
spring force if it is bent backwardly along with one of the plies.” Id. at col.9 ll.52–56. And this
backward bending of the plies is in the context of the user opening the pouch to extract the patch
by “grasp[ing] the opposing tabs 40 and 42 with fingers of opposite hands, and pull[ing] the tabs
40 and 42, and thus the plies 22 and 24.” Id. at col.9 ll.36–50. “The spring force is sufficient to
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cause the patch (together with the liner) to peel away from the ply (that is being held by fingers
of the user), resulting in the patch being presented, in a ‘free’ state, for removal by the user from
between the plies.” Id. at 10 ll.15–19. Thus, the Court understands that the bending of the “bent
out of the flat configuration” is due to the bending of the ply to which the patch adheres, and that
the patch is “resilient” enough to return to a substantially flat position after such bending.
Finally, the patch of claim 14 is a structure having a particular property (resilient) that
gives it the capability to “return to a substantially flat orientation after being bent out of the flat
configuration.” The claim is directed to capability, not to the act of bending the patch. See
UltimatePointer, L.L.C. v. Nintendo Co., 816 F.3d 816, 826 (Fed. Cir. 2016). This is true even if
the patch must be bent to determine if it has the capability of returning to a substantially flat
orientation after being bent.
Accordingly, the Court holds that this term does not render any claim indefinite and
construes it as follows:
•
“substantially flat orientation” means “orientation that would allow the patch to fit
in the same shipping/packaging space as when in its original orientation”; and
•
“bent out of the flat configuration” means “bent out of the flat configuration by
the adhesive force binding the patch to the ply which is bent.”
D.
“the first and the second plies each being separable along the seal”
Disputed Term
“the first and the second
plies each being separable
along the seal”
•
Plaintiff’s Proposed
Construction
Plain and ordinary meaning.
’999 Patent Claims 1, 14
- 28 -
Defendant’s Proposed
Construction
“the first and second plies
both come apart at the seal”
The Parties’ Positions
Plaintiff submits that this term is readily understood by one of ordinary skill in the art and
by lay person alike, and therefore does not need to be construed. (Dkt. No. 46 at 24). Plaintiff
argues that Defendant’s proposed construction would improperly change the scope of the claims,
not clarify them. (Id. at 25). Specifically, Plaintiff contends that “separable along the seal” is not
the same as “come apart at the seal” as Defendant proposes. (Id.). Plaintiff argues that such a
redrafting threatens to inject a method step in the apparatus claims that requires the plies “come
apart” as opposed to having the property that they are “separable.” (Id.).
Defendant responds that the “invention requires both plies separate entirely from each
other at the seal, or at the point where both plies are in contact with each other.” (Dkt. No. 49 at
29).
In addition to the claims themselves, Defendant cites the following intrinsic evidence to
support its position: ’999 Patent col.5 ll.21–22, col.5 ll.24–39.
Plaintiff replies that this term simply explains that the plies are able to be separated from
each other along the seal. (Dkt. No. 51 at 11). Plaintiff further replies the ’999 Patent’s claims
and description are clear that the seal need only extend around a portion of the perimeters of the
plies, and that the plies may be separated along the seal other than being separated entirely from
each other, as Defendant contends. (Id.).
Plaintiff cites further intrinsic evidence to support its position: ’999 Patent col.2 ll.33–
35, figs.3, 4A, 4B, 5.
- 29 -
Analysis
The issue here is whether the plies must completely separate from each other in order to
be “separable along the seal.” They do not. Neither Defendant nor Plaintiff objected to the
Court’s construction at the hearing.
Figure 1 of the ’999 Patent,
reproduced here and annotated by the
Court, depicts an embodiment in which
the seal (32, in purple) extends around
the entire perimeter of the plies. ’999
Patent col.8 ll.60–62, fig.1. Figure 4B,
seal
reproduced here and annotated by the Court, depicts the Figure 1 embodiment in an open
position—in which portions of the plies (20, 24) are “separated along the seal.” Id. at col.3 ll.24–
26, col.9 ll.29–34. There is no reasonable argument that “separable along the seal” means
anything other than “capable of being separated along the seal.” And the patent clearly describes
that the plies are separated along the seal to “open the enclosure and expose the patch,” as recited
in the claim, when portions of the plies are separated along the seal.
Accordingly, the Court rejects Defendant’s “both come apart at the seal” limitation and
determines that the term has its plain and ordinary meaning and does not need to be further
construed.
V.
CONCLUSION
The Court adopts the above constructions set forth in this opinion for the disputed and
agreed terms of the ’999 Patent. The parties are ordered that they may not refer, directly or
indirectly, to each other’s claim construction positions in the presence of the jury. Likewise, the
- 30 -
parties are ordered to refrain from mentioning any portion of this opinion, other than the actual
definitions adopted by the Court, in the presence of the jury. Any reference to claim construction
proceedings is limited to informing the jury of the definitions adopted by the Court.
SIGNED this 3rd day of January, 2012.
SIGNED this 9th day of July, 2016.
____________________________________
ROY S. PAYNE
UNITED STATES MAGISTRATE JUDGE
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