Source: s3://data.kl3m.ai/documents/govinfo/USCOURTS/USCOURTS-cand-3_09-cv-02280/USCOURTS-cand-3_09-cv-02280-17/pdf.json

Nature of Suit Code: 830
Nature of Suit: Patent
Cause of Action: 35:145 Patent Infringement

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United States District Court

For the Northern District of California

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IN THE UNITED STATES DISTRICT COURT

FOR THE NORTHERN DISTRICT OF CALIFORNIA

CONCEPTUS, INC.,

Plaintiff,

 v.

HOLOGIC, INC.,

Defendant. /

No. C 09-02280 WHA

TENTATIVE CLAIM

CONSTRUCTION ORDER AND

REQUEST FOR CRITIQUE

INTRODUCTION

In this patent infringement action involving intrafallopian contraceptive devices, the

parties seek construction of six terms and phrases found in asserted claims 8, 37, and 38 of U.S.

Patent No. 6,634,361 and asserted claims 5 and 14 of U.S. Patent No. 7,506,650. These terms and

phrases are construed below. The parties will have until NOON ON FRIDAY, MARCH 19, 2010, to

submit a five-page critique (double-spaced, no footnotes, and no attachments) limited to the

points of critical concern. In light of the voluminous briefing already submitted and the lengthy

hearing on these matters, this is an opportunity for the parties to focus solely on their most cogent

critique.

STATEMENT

Plaintiff Conceptus, Inc. sells a transcervically introduced permanent contraceptive

product called Essure. It received FDA approval in 2002, and is currently plaintiff’s only

marketed product. Unlike tubal ligation, the Essure system allegedly requires no incisions and is

minimally invasive. According to plaintiff, Essure can be placed within the fallopian tubes of the 

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recipient by way of the cervix in a ten-minute, non-surgical procedure that can be performed in a

doctor’s office without general anesthesia. Essure’s contraceptive efficacy is supposedly

achieved through occlusion (i.e. blocking) of the fallopian tube. 

Defendant Hologic, Inc. owns and markets the accused Adiana contraceptive system. The

Adiana system, like the Essure system, supposedly involves the minimally invasive transcervical

placement of a contraceptive device (referred to by Hologic as a “matrix”) into the fallopian tubes

of the recipient. Combined with the use of radiofrequency energy, the Adiana system — much

like the Essure system — is intended to produce intrafallopian occlusion, which either prevents

conception from occurring or the passage of a fertilized ovum to the uterus. Adiana received

FDA approval in July 2009. 

Targeting the fallopian tubes is a well-known approach to permanent contraception. 

Referring to the basics of reproductive biology, sperm enter the fallopian tubes by way of the

uterus. Ova, on the other hand, travel in the opposite direction towards the uterus from the

ovaries. Thus, blocking the fallopian tubes is a sensible way to prevent sperm from meeting and

fertilizing an ovum.

Tubal ligation, a longstanding but highly invasive procedure for permanent sterilization,

works similarly to the contraceptive invention covered by the patents-in-suit; it physically

prevents the meeting of sperm and ova. Tubal ligation can be performed in a variety of ways,

including clipping the fallopian tubes, cutting and tying the fallopian tubes, banding the fallopian

tubes, or cauterizing the fallopian tubes. An illustration of some of these techniques is shown

below (Compl. ¶ 7):

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Unlike tubal ligation, the patents-in-suit cover an intrafallopian contraceptive system

where a contraceptive invention is placed within the reproductive system via the cervix using

specially adapted tools. No cutting, banding, or cauterizing is supposedly necessary. Rather than

blocking the fallopian tubes using external mechanical methods (as done in tubal ligation), the

devices in the asserted patents serve their intended purposes by blocking the fallopian tubes from

within. 

At the onset of this litigation, five patents were originally asserted by Conceptus (Dkt.

Nos. 1, 12). Of these five patents, a single claim — claim 94 of U.S. Patent No. 7,428,904 —

formed the basis for an unsuccessful preliminary injunction motion (Dkt. Nos. 91, 131). 

Thereafter, the parties stipulated to eliminating three of the five asserted patents (including the

’904 patent) from the dispute (Dkt. No. 140). As such, only two patents and five claims currently

remain. The Court thanks counsel for taking steps toward streamlining the case.

The ’361 and ’650 patents — the two remaining in this action — cover separate aspects of

the contraceptive invention. The ’361 patent covers the intrafallopian contraceptive device itself,

as well as various methods for the device’s placement within the fallopian tube. The ’650 patent,

by contrast, involves the deployment system for the device (meaning, the apparatus used to place

the contraceptive device within the fallopian tubes). With this background in place, this order

now turns to the disputed claim terms and phrases.

ANALYSIS

Courts must determine the meaning of disputed claim terms from the perspective of one of

ordinary skill in the pertinent art at the time the patent was filed. Chamberlain Group, Inc. v.

Lear Corp., 516 F.3d 1331, 1335 (Fed. Cir. 2008). While claim terms “are generally given their

ordinary and customary meaning,” the “claims themselves provide substantial guidance as to the

meaning of particular claim terms.” Phillips v. AWH Corp., 415 F.3d 1303, 1312, 1314 (Fed. Cir.

2005) (en banc) (quoting Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1582 (Fed. Cir.

1996)). As such, other claims of the patent can be “valuable sources of enlightenment as to the

meaning of a claim term.” Vitronics, 90 F.3d at 1582. Additionally, a patent’s specification “is

always highly relevant to [] claim construction[.]” Phillips, 415 F.3d at 1315 (quoting Vintronics,

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90 F.3d at 1582). Indeed, claims “must be read in view of the specification, of which they are a

part.” Markman v. Westview Instruments, Inc., 52 F.3d 967, 979 (Fed. Cir. 1995) (en banc), aff’d,

517 U.S. 370 (1996). Finally, courts should also consider the patent’s prosecution history, which

“can 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 prosecution, making the

claim scope narrower than it would otherwise be.” Phillips, 415 F.3d at 1318 (citations omitted). 

These components of the intrinsic record are the primary resources in properly construing claim

terms. Id. at 1317–18.

While this order acknowledges that the parties have a right to the construction of all

disputed claim terms by the time the jury instructions are settled, the Court will reserve the

authority, on its own motion, to modify the constructions in this order if further evidence —

intrinsic or extrinsic — warrants such a modification. Given that claim construction is not a

purely legal matter, but is (as the Supreme Court describes it) a “mongrel practice” with

“evidentiary underpinnings,” it is entirely appropriate for the Court to adjust its construction of

claims prior to trial if the evidence compels an alternative construction. Markman, 517 U.S. at

378, 390. For the same reasons, this order will not be bound by prior constructions of similar

terms in different patents, as urged by Hologic multiple times in its responsive brief (Resp. 5,

11–12). The ’904 patent — the star of the preliminary injunction — is no longer being asserted in

this action, and preliminary constructions of its terms have no bearing herein. 

The parties should be aware, however, that they are not invited to ask for reconsideration

of the constructions herein. Motions for reconsideration may only be made, if at all, in strict

accordance with the rules of procedure.

1. THE ’361 PATENT 

The ’361 patent, entitled “Contraceptive Transcervical Fallopian Tube Occlusion Devices

And Methods,” was issued on October 21, 2003. Conceptus is the assignee of the ’361 patent. 

Three claims from this patent are asserted in this litigation: independent claim 8, and dependent

claims 37 and 38. Five of the six disputed terms and phrases in this order are found in the ’361

patent. These terms and phrases are italicized in the claims below.

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Claim 8 covers (col. 20:21–33):

8. A tissue ingrowth contraceptive device for use in a

fallopian tube, the contraceptive device comprising:

a resilient elongate body having a proximal end and a distal

end and defining an axis therebetween;

a retention structure disposed along the resilient body, the

retention structure adapted to restrain the resilient body

within the fallopian tube;

a bond affixing the retention structure to the resilient body;

wherein at least one of the resilient body, the retention

structure, and the bond comprises a microporous material

which promotes tissue ingrowth therein.

Claims 37 and 38 (as well as independent claim 36, which they reference) cover (col.

23:38–53):

36. An intrafallopian contraceptive method comprising: 

transcervically introducing a pre-formed resilient structure

into a target region of a fallopian tube;

imposing an anchoring force against a tubal wall of the

fallopian tube by resiliently engaging in inner surface of

the tubal wall with the resilient structure; and

permanently affixing the resilient structure within the

fallopian tube with a lumen-traversing region of the

resilient structure so that at least a portion of the fallopian

tube is open.

37. A method as claimed in claim 36, wherein the affixing step

comprises promoting tissue ingrowth of the tubal wall surrounding

the resilient structure.

38. A method as claimed in claim 37, wherein the tissue

ingrowth occludes the fallopian tube to inhibit contraception.

A. “resilient elongate body / pre-formed resilient structure”

The parties dispute the phrases “a resilient elongate body” and “pre-formed resilient

structure.” The former phrase is found in claim 8, while the latter phrase is found in claim 36

(upon which asserted claims 37 and 38 are dependent). The parties’ proposed constructions are

shown below.

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CONCEPTUS’S PROPOSED

CONSTRUCTION

HOLOGIC’S PROPOSED

CONSTRUCTION

Claim 8: “a resilient elongate

intrafallopian device”

Claims 37 and 38: “pre-formed

resilient intrafallopian device” 

Claim 8: “a resilient elongate

intrafallopian device that includes, at

least in part, metal” and 

Claims 37 and 38: “pre-formed

resilient intrafallopian device that

includes, at least in part, metal” 

Conceptus and Hologic agree that the terms “body” and “structure” in the above phrases

refer to an “intrafallopian device.” Where the parties disagree, however, is whether the

intrafallopian device must be one “that includes, at least in part, metal.” Conceptus points to the

claim language and specification to argue that the claims never set forth a “metal” limitation, and

the specification never evidenced a clear intent to limit the claims in such a manner. Hologic

counters with the fact that every disclosed embodiment in the specification included a metal coil

or component. For the reasons explained below, this order finds that Hologic has failed to show

an intent by the patentee to limit the claims in the manner proposed.

The language of claims 8 and 36 are entirely devoid of any limitation that the

intrafallopian device “include[], at least in part, metal.” Dependent claims 37 and 38 — which

build upon claim 36 — similarly lack limitations involving metal. As such, Hologic’s proposed

construction immediately challenges the presumption that “the words of the claim . . . define the

scope of the patent.” Kinetic Concepts, Inc. v. Blue Sky Medical Group, Inc., 554 F.3d 1010,

1027 (Fed. Cir. 2009) (citing Phillips, 415 F.3d at 1312). Hologic must therefore show that

despite the absence of such a limitation in the asserted claims, the intrinsic evidence shows that

the patentee clearly intended the contraceptive device to include metal.

On this point, a distinction must be drawn between the use of copper in the present

invention, and the use of metal in general in the claimed device. The specification contained

numerous references to “[t]he efficacy of the device [being] enhanced by forming the structure at

least in part from copper or a copper alloy” (cols. 1:53–55, 3:7–9, 8:10–24, 9:34–46,

18:50–19:16). This is because copper provided “not fully understood” benefits in disrupting the

reproductive process in the fallopian tube (col. 8:21–25). Indeed, three claims in the ’361 patent

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— which are not being asserted here — included express limitations requiring the use of copper

(cols. 24:32–34, 24:35–39). In sum, the specification discussed the use of copper in the device as

a means to improve its contraceptive efficacy, but not as a required component in every

embodiment. Hologic admitted as much at the claim construction hearing. It does not argue that

copper must be present in all embodiments.

Rather, Hologic’s argument is directed towards the use of metal in general as a structural

material in the device. To support its argument, Hologic notes that the specification never

disclosed any embodiments that did not use metal (or, more specifically, a metal coil) to form the

“resilient structure” — or backbone — of the device. This is true. The first embodiment of the

contraceptive device, as disclosed by the specification, appeared to require the presence of metal

in its primary coil component (see col. 9:34–46, noting that the primary coil is “preferably . . .

formed from a beryllium copper alloy” or “[a]lternatively . . . from a resilient metal”). FIG. 1

below represents this first embodiment, with the primary coil denoted by the number 12.

An alternative embodiment disclosed in the specification, referred to herein as the

“straight” embodiment, similarly appeared to require the use of metal in its primary coil (see col.

11:52–12:19). This straight embodiment is shown in FIG. 11A below, with the primary coil

denoted as 202.

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Indeed, all embodiments of the invention disclosed by the patent appeared to feature a “primary

coil,” and this coil appeared to be metallic when specifically described in the specification (see

col. 19:19–24).

While this intrinsic evidence lends support to Hologic’s proposed construction, it falls

short of a “clear intention” by the patentee to limit the claim scope. LiebelFlarsheim Co. v.

Medrad, Inc., 358 F.3d 898, 905 (Fed. Cir. 2004) (holding that when the specification uses a

single embodiment to enable the claims, broader claim language should not be limited to that

embodiment “unless the patentee has demonstrated a clear intention to limit the claim scope using

words or expressions of manifest execution or restriction”). As Conceptus pointed out at the

claim construction hearing, the specification clearly stated that “[t]he intrafallopian device of the

present invention . . . often comprises a resilient structure, usually a metallic coil . . . ideally

comprising an alloy including at least 75% copper” (col. 3:14–17) (emphases added). Moreover,

the specification itself noted that contraceptive devices in the prior art were made of different

non-metal materials, such as silicone (see col. 1:54–55, 2:33–36).

Given this information, a person having ordinary skill in the relevant art at the time the

patent was filed would have understood that metal coils were used in the disclosed embodiments

because they were “biocompatible” while having the “strength” and “resiliency” to function, in

coil form, as the invention’s “resilient structure” (see cols. 9:21–22, 9:35–38, 9:42–44). In other

words, the specification disclosed using metal coils because they “provide[d] the resilience

necessary to avoid expulsion of the device” (col. 9:35–38). That said, the specification never

stated that metal (or metal coils) were required to provide this necessary resilience. Given that

non-metallic devices were prevalent in the prior art at the time the patent application was filed, a

person having ordinary skill in the art would have understood that the resilient structure could be

made of any material, so long as the structure was sufficiently resilient.

Indeed, the claims themselves support this conclusion. Claims 1 and 3 of the ’361 patent

contain an express “coil” limitation (cols. 19:33–45, 19:49–62). The asserted claims, however, do

not (cols. 20:21–33, 23:38–53). Additionally, as Hologic admitted at the hearing, the retention

structure of the device — which may (or may not) be a separate component from the resilient

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structure in various embodiments — does not need to be made out of metal (cols 13:57–60,

14:1–3, 13:14:6–10). Viewing this intrinsic evidence as a whole, this order cannot find that the

patentee “demonstrated a clear intention to limit the claim scope” of the asserted claims to

include, at least in part, metal. See LiebelFlarsheim, 358 F.3d at 905. 

None of the decisions cited by Hologic compels a contrary conclusion. In Kinetic

Concepts, the court limited the claim term “wound” to “skin wounds” because the specification

“in no way suggest[ed]” that non-skin wounds “[could] be treated according to the claimed

invention.” 554 F.3d 1010, 1018 (Fed. Cir. 2009). By contrast, the claims in the ’361 patent

clearly distinguished between coil-based and generic resilient structures, and the specification

expressly left open the possibility of using resilient structures other than metal coils. Also

distinguishable is ICU Medical, Inc. v. Alaris Medical Systems, Inc., which relied upon an

implied functional limitation in the specification to construe the claim term “spike.” 558 F.3d

1368, 1374–76 (Fed. Cir. 2009). In ICU Medical, the specification made clear that the “spike”

needed to be pointed, since its function was to pierce a seal. Thus, that limitation was properly

read into the claim. Hologic fails to point to an equivalent functional limitation here. While it is

true — at least based upon the specification — that certain metals provide the resilience necessary

for the present device to function, resilience inhered in non-metal materials as well. Finally,

Netcraft Corp. v. eBay, Inc. is cited by Hologic without explanation, but it involved a patent

where the term “present invention” was used with abandon through the specification, and the

claims were limited to those features disclosed. 549 F.3d 1394, 1397–98 (Fed. Cir. 2008). 

Netcraft, however, expressly acknowledged that “use of the phrase ‘the present invention’ does

not ‘automatically’ limit the meaning of claim terms in all circumstances, and that such language

must be read in the context of the entire specification and prosecution history.” Id. at 1398 (citing

Rambus Inc. v. Infineon Techs. AG, 318 F.3d 1081, 1094 (Fed. Cir. 2003)). As stated, this order

gives full consideration of the entire specification, and finds that the intrinsic evidence does not

support Hologic’s argument that the claims be limited to the particular embodiments disclosed in

the patent. 

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In sum, while all parties agree that the specification clearly set forth metallic preferences

— copper for its contraceptive efficacy and metal coils for their “strength” and “resiliency” as a

structural component — it expressly avoided setting forth a manifest limitation that the invention

include metal. A person having ordinary skill in the relevant art at the time the application was

filed would have understood that the “resilient structure” need only be resilient enough to serve

its intended purpose. It need not be made out of metal coils, or even metal at all.

As such, this order adopts Conceptus’s proposed constructions for the phrases “a resilient

elongate body” and “pre-formed resilient structure” found in claims 8, 37, and 38.

B. “a bond affixing the retention structure to the resilient body”

The next disputed phrase, “a bond affixing the retention structure to the resilient body,” is

found solely in claim 8. Only Hologic seeks a construction of this particular phrase. Conceptus,

by contrast, asserts that the phrase does not require construction, and that its plain meaning should

apply (Br. 9–10). Hologic’s proposed construction is shown below.

CONCEPTUS’S PROPOSED

CONSTRUCTION

HOLOGIC’S PROPOSED

CONSTRUCTION

Plain meaning applies. No construction

necessary.

“solder or a similar type material for

affixing the retention structure to the

resilient body”

The term “bond” appears in various portions of the specification (see, e.g., cols. 3:57–62,

4:55–57), as well as in the discussion and drawings of particular embodiments (see, e.g., cols.

14:63–66, 15:3–7, 15:32–35, 15:66–16:2; FIGS. 14, 14A–C). To provide a visual example, FIG.

14A below shows a “bond” (206) affixing a retention structure (204) to the resilient body (202) in

a particular embodiment of the present invention.

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Hologic’s proposed construction attempts to limit the “bond” between the retention

structure and resilient body of the present invention to a “solder or a similar type material” (Resp.

8–10). Nothing in the intrinsic evidence, however, supports such a limitation. While a “solder

bond” is mentioned once in the specification, the context of its use has nothing to do with affixing

the retention structure to the resilient body (see col. 3:57–62, using a “solder bond” to describe

the attachment of the contraceptive device to an installation apparatus). As such, Hologic’s

construction improperly imports a limitation into the claim without any support in the

specification, and must be rejected. See Abbott Labs. v. Sandoz, Inc., 566 F.3d 1282, 1288 (Fed.

Cir. 2009) (explaining that courts must be careful to not improperly import limitations from the

specification into the claims); LiebelFlarsheim, 358 F.3d at 905.

This does not mean, however, that plain meaning should apply (Br. 9–10). As Hologic

explained at the claim construction hearing, it’s underlying concern with respect to the term

“bond” — reflected in its proposed construction — was that it could be stretched to encompass

bonds on a molecular level (Resp. 8–9). Using such a construction, a unitary device, having no

disparate parts that have ever been joined together, could still be argued to the jury as meeting the

“bond” limitation. Given this dispute over the appropriate meaning of “bond,” construction of the

phrase is perhaps necessary. See O2 Micro Intern. Ltd. v. Beyond Innovation Technology Co.,

Ltd., 521 F.3d 1351, 1361 (Fed. Cir. 2008) (“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.”). 

Looking to the language of claim 8, the context of the phrase “a bond affixing the

retention structure to the resilient body” plainly contemplates the joining of two disparate

components of the claimed device: namely, a retention structure and a resilient body. Adding

support to this reading of claim 8 is the fact that it separately lists “a resilient elongate body,” “a

retention structure,” and “a bond affixing the retention structure to the resilient body” as three

distinct components of the invention (see col. 20:21–33). Given this language, this order finds

that the patentee would not have called out “a bond affixing the retention structure to the resilient

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body” if the resilient elongate body and retention structure were already one and the same. Stated

differently, the “bond” in claim 8 would serve no purpose if the retention structure and resilient

body were already affixed to each other.

Since courts must interpret claim terms in the context of the claim as a whole, see Kyocera

Wireless Corp. v. International Trade Comm’n, 545 F.3d 1340, 1347 (Fed. Cir. 2008), this order

finds that a person of ordinary skill in the relevant art at the time the patent was filed would have

construed the phrase “a bond affixing the retention structure to the resilient body” as meaning “a

bond affixing the retention structure to the resilient body, where without the bond, the retention

structure and resilient body would be unaffixed components.”

C. “permanently affixing the resilient structure within the fallopian tube”

The third disputed phrase is “permanently affixing the resilient structure within the

fallopian tube” found in claims 37 and 38. Proposed constructions are shown below:

CONCEPTUS’S PROPOSED

CONSTRUCTION

HOLOGIC’S PROPOSED

CONSTRUCTION

“affixing the resilient structure within

the fallopian tube, such that it remains

(or is intended to remain) affixed in the

fallopian tube for a long, indefinite

period”

“affixing the resilient structure within

the fallopian tube so long as it is in the

tube, e.g., is not expelled or absorbed”

At the heart of this dispute is what is meant by the word “permanently.” Both parties

agreed during oral argument that the term pertains to permanent contraception — a conclusion

that finds ample support in the specification (see, e.g., cols. 1:27–35, 1:57–58, 2:54–60, 7:65–67). 

Indeed, the specification frequently emphasized that one of the objects of the present invention

was to improve upon the “unacceptably high percentage” of non-surgical intrafallopian

contraceptive devices that became unintentionally dislodged (i.e., did not remain in place and

were expelled) after being inserted into the fallopian tube (cols. 2:1–4, 8:46–48).

Despite this agreement, Conceptus and Hologic nevertheless propose two different

constructions commensurate with their respective strategic needs. Both constructions are

confusing and flawed. For example, Conceptus’s proposed construction inexplicably introduces a

subjective element — “intended to remain” — into the claim, but never explains whose subjective

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 Hologic’s last-minute argument that this phrase is indefinite is both untimely and

without merit. Both parties essentially agreed at oral argument on the basic meaning of the

term “permanently.” The parties merely differ over the details of its construction. See Exxon

Research & Eng’g Co. v. United States, 265 F.3d 1371, 1374 (Fed. Cir. 2001) (“If the

meaning of the claim is discernible, even though the task may be formidable and the

conclusion may be one over which reasonable persons will disagree, we have held the claim

sufficiently clear to avoid invalidity on indefiniteness grounds.”).

13

intent is at issue. Additionally, Conceptus would require the contraceptive device to remain

“affixed in the fallopian tube for a long, indefinite period.” How one would go about proving that

an accused device met such a limitation is a mystery to all involved.

Hologic’s proposed construction is equally confusing. Not only does it inexplicably add

the limitation that the contraceptive device not be “absorbed,” it equates “permanently” with

simply being “within the tube.” This is contrary to the plain meaning of the word “permanently”

as used in the context of the claim, and would only serve to confuse the jury.1

Having considered the context of the disputed phrase within the claim language, and the

fact that the specification did not impart “permanently” with a definition that was different from

its plain and ordinary meaning, this order finds that no construction is required for the phrase

“permanently affixing the resilient structure within the fallopian tube.”

D. “lumen-traversing region of the resilient structure”

The parties dispute the phrase “lumen-traversing region of the resilient structure” from

claims 37 and 38. As explained in an earlier footnote, the lumen is the inner open space or cavity

of a tubular organ. Used here, it is simply the open space within a fallopian tube.

CONCEPTUS’S PROPOSED

CONSTRUCTION

HOLOGIC’S PROPOSED

CONSTRUCTION

“region of the resilient structure that

crosses the width of the fallopian tube”

“a section of the resilient structure

that crosses the entire length of the

fallopian tube lumen” 

The parties could not be more diametrically opposed on the meaning of the phrase

“lumen-traversing region.” Conceptus argues that it refers to the part of the contraceptive device

that traverses the entire width — meaning the diameter or cross-section — of the lumen, while

Hologic contends that it pertains to the portion of the device traversing the entire length of the

fallopian tube. As explained below, neither construction seems entirely correct.

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Only some embodiments of the present invention have a clearly denoted “lumentraversing region.” In the embodiment shown in FIG. 1 (reproduced again below), the area

denoted by number 24 is the “lumen-traversing region” (col. 9:7–12). 

On either side of the lumen-traversing region are the “anchors” of the device, with the

“proximal anchor” denoted by 20 and the “distal anchor” denoted by 22. These anchors serve

their named purpose — they keep the contraceptive device “anchored” in the fallopian tube so

that the device is not expelled.

When the embodiment shown in FIG. 1 is inserted into the fallopian tube, the anchors are

actually not curled — rather, they held in a straight position to ease the insertion of the device. 

When the device is placed within the fallopian tube, the proximal and distal anchors are ideally

placed on either side of the narrowest part of the tube (col. 8:43–53). That way, when the anchors

are unfurled, the device is held snugly within the tube. FIG. 10 below illustrates the placement of

the FIG. 1 embodiment within the fallopian tube.

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In FIG. 10 shown above, the narrowest part of the fallopian tube, called the “isthmus,” is

denoted by 80, while the proximal and distal anchors of the FIG. 1 embodiment are shown as 92

(the proximal anchor) and 90 (the distal anchor). 

Given this intrinsic evidence, it is clear that Hologic’s proposed construction cannot be

correct. The device shown in FIG. 10 clearly does not traverse the entire length of the fallopian

tube. Rather, there are portions of the fallopian tube beyond the distal anchor of the

contraceptive device (shown in FIG. 10 as 90) that the device does not occupy. Moreover, the

specification expressly stated that the invented device could span various other portions of the

tubal lumen (see cols. 3:49–52, 8:55–58). In sum, Hologic’s proposed construction is contrary to

the teachings of the specification, and improperly excludes numerous disclosed embodiments. As

such, it must be rejected. See Vitronics, 90 F.3d at 1583 (holding that a construction that

excluded a preferred or disclosed embodiment would be “rarely, if ever, correct and would

require highly persuasive evidentiary support”); see also Verizon Servs. Corp. v. Vonage

Holdings Corp., 503 F.3d 1295, 1305 (Fed. Cir. 2007) (if a disputed claim term has multiple

ordinary meanings, the court should adopt the ordinary meaning that includes the disclosed

examples in the specification). 

Conceptus’s proposed construction is also problematic. In claim 35 (which is not asserted

in this action), the “lumen-traversing region” is expressly defined by the claim as the region

“extending between the proximal and distal anchors” (col. 23:31–37). This is exactly as the

“lumen-traversing region” is described for the embodiments in FIGS. 1 and 6 (col. 9:11–13). By

contrast, claim 36 — in the spotlight here — does not define the “lumen-traversing region” by

reference to proximal and distal anchors. Rather, the “lumen-traversing region” is defined solely

by claim 36 as the region of the resilient structure that is used to “permanently affix[] the resilient

structure within the fallopian tube” (see col. 23:45–48). 

Nothing in claim 36 or the specification requires that the contraceptive device “cross[] the

width of the fallopian tube” to be permanently affixed within the fallopian tube. Granted,

crossing the width of the fallopian tube might maximize the interaction of the device with the

surrounding lumenal wall, which might be ideal in ensuring that the device is permanently affixed

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 This order does not rely on the expert testimony of Dr. Mark Glasser to construe

this, or any disputed phrase. As such, Hologic’s evidentiary objections to Dr. Glasser’s

testimony are denied at moot. 

16

within the tube (especially for those embodiments that promote tissue ingrowth). The intrinsic

evidence, however, does not require limiting the claims to such an ideal embodiment.

Indeed, a person having ordinary skill in the relevant art at the time the patent was filed

would have understood, after reading the entire patent, that the lumen-traversing region of the

contraceptive device could be lodged against one side of the fallopian tube (and not cross the

entire width of the lumen) and still be entirely capable of becoming permanently affixed within

the tube. This is because fallopian tube cross-sections can vary significantly in size, and the

invention contemplates various means of affixing the device within the fallopian tube without

mentioning any requirement that the device cross the entire width of the fallopian tube (see cols.

11:42–45, 16:52–54, 17:52–58). Moreover, it is unclear what Conceptus would consider the

“width” of the lumen, given the fact that the lumen (depicted as “L” in FIG. 15A below) contains

numerous folds. 

Since the specification failed to clearly define or denote the term “lumen-traversing

region,” this order will construe “lumen-traversing region” as it is defined by the language in

claim 36. As such, the phrase “lumen-traversing region of the resilient structure” shall be

construed as the “region of the resilient structure that interacts with the wall of the fallopian tube

lumen to permanently affix the resilient structure within the fallopian tube lumen.”2

E. “so that at least a portion of the fallopian tube is open”

The final disputed phrase from the ’361 patent is “so that at least a portion of the fallopian

tube is open” from claims 37 and 38. Proposed constructions are shown below.

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CONCEPTUS’S PROPOSED

CONSTRUCTION

HOLOGIC’S PROPOSED

CONSTRUCTION

“so that at least a portion of the

fallopian tube is not completely

occluded”

Indefinite subject to 35 U.S.C. 112. 

Otherwise:

“that there is no obstruction in the

fallopian tube preventing the meeting

of sperm and ovum” 

As a preliminary matter, Hologic’s indefiniteness argument must be rejected. As the

analysis below illustrates, this phrase is amenable to construction in light of the specification. 

Given this conclusion, the phrase is not indefinite. See Exxon Research & Eng’g Co. v. United

States, 265 F.3d 1371, 1374 (Fed. Cir. 2001).

This construction boils down to the differences between complete (or total) occlusion of

the fallopian tube and “functional occlusion” of the fallopian tube. As explained in the summary

of the invention, while the contraceptive device in the asserted patent “will generally result in

occlusion, it need not completely occlude the fallopian tube to prevent the meeting of the sperm

and ovum” (col. 3:22–24) (emphasis added). “[C]ontraception can be provided by disrupting the

architecture and/or function of the fallopian tube, despite the presence of an open lumen” (col.

3:27–29) (emphasis added). “This concept is referred to herein as ‘functional occlusion’” (col.

3:29–30). In other words, the specification clearly taught that the intrafallopian contraceptive

device need not block the entire lumenal cavity to provide effective contraception (see cols.

4:29–34, 11:27–34). Despite the presence of an open lumen, the device may still provide

effective contraception so long as there is “functional occlusion” to “inhibit fertilization and/or

conception” (col. 3:30–34).

With this definition of “functional occlusion” from the specification, the claims provide

all the information necessary to properly construe this disputed phrase. Specifically, claim 40 —

which is not asserted in this action — covers “[a] method as claimed in claim 36, wherein

permanently affixing the resilient structure with the fallopian tube provides functional occlusion

of the fallopian tube.” Given that “functional occlusion” is only necessary when the fallopian

tube is not completely occluded, this necessarily implies that the fallopian tube in claim 36 has

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this feature. Indeed, this is exactly what a person having ordinary skill in the relevant art at the

time the patent was filed would have understood “so that at least a portion of the fallopian tube is

open” to mean.

Moreover, asserted claims 37 and 38, which cover “tissue ingrowth,” would also be

meaningless if the fallopian tube in claim 36 were already completely occluded (see col.

4:21–22). Indeed, the specification stated that “[i]n many embodiments, the presence of the

contraceptive device in combination with [] tissue reaction can provide effective contraception

without having to rely on total occlusion of the fallopian tube” (col. 4:30–34) (emphasis added). 

Stated differently, the promotion of tissue ingrowth into the device (claim 37) can produce

sufficient ingrowth to inhibit contraception (claim 38), despite the fact that the fallopian tube was

not completely occluded when the contraceptive device was initially affixed (claim 36).

As such, Conceptus’s proposed construction is correct, and the phrase “so that at least a

portion of the fallopian tube is open” from claims 37 and 38 patent shall mean “so that at least a

portion of the fallopian tube is not completely occluded.” 

2. THE ’650 PATENT

The final construction in this order pertains to the ’650 patent. The ’650 patent, entitled

“Deployment Actuation System For Intrafallopian Contraception,” was issued on March 24,

2009. Unlike the prior patent, the ’650 patent covers a “delivery mechanism” used to place

contraceptive devices within the fallopian tube, rather than the contraceptive devices themselves

(Br. 5). Conceptus is the assignee of this patent.

Two claims from the ’650 patent — method claim 5 and apparatus claim 14 — are

asserted in this litigation. The disputed phrases construed below are found in both of these

claims.

Claim 5 covers (col. 19:41–20:8):

5. A contraceptive method comprising:

inserting a contraceptive device transcervically into an

ostium of a fallopian tube by gripping a handle with a hand

and moving the hand, the handle coupled to the

contraceptive device by an elongate body;

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Withdrawing a sheath surrounding the elongate body and at

least a portion of the contraceptive device by moving the

sheath proximally relative to the elongate body to expose

the contraceptive device, such movement effected by

moving an actuator on the handle with the hand while the

hand grips the handle; and

detaching the contraceptive device from the elongate body

within the ostium to inhibit contraception.

Claim 14 (which is dependent upon claim 9) covers (cols. 20:19–32, 20:43–44):

9. A contraceptive delivery system comprising:

a contraceptive device insertable into an ostium of a

fallopian tube;

a deployment shaft having a proximal end and a distal end

releasably coupled to the contraceptive device;

a proximal handle connected with the proximal end of the

deployment shaft, the handle having a size and shape

suitable for gripping with a single hand;

an at least one actuator mounted on the handle, wherein

movement of the at least one actuator by the hand while the

hand grips the handle releases the contraceptive device

from the distal end of the deployment shaft; and

conductors extending along the deployment shaft to

provide energy to at least a portion of the fallopian tube.

* * *

14. The contraceptive delivery system of claim 9, wherein the

conductors provide radiofrequency energy.

A. “the handle coupled to the contraceptive device by an elongate body” / “a

deployment shaft having a proximal end and a distal end releasably coupled

to the contraceptive device”

The parties have engineered a “two-for-one” deal with this final construction. While both

Conceptus and Hologic framed this dispute as being centered on the term “coupled,” two separate

phrases — each using the term “coupled” in slightly different contexts — were targeted for

construction. Specifically, the parties asked the Court to construe the phrases “the handle coupled

to the contraceptive device by an elongate body” (from claim 5) and “a deployment shaft having a

proximal end and a distal end releasably coupled to the contraceptive device” (from claim 9). 

Proposed constructions are shown below.

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CONCEPTUS’S PROPOSED

CONSTRUCTION

HOLOGIC’S PROPOSED

CONSTRUCTION

Claim 5: “the handle paired to or joined

with the contraceptive device by an

elongate body”

Claim 14: “a deployment shaft having

a proximal end and a distal end paired

to or joined with the contraceptive

device”

Claim 5: “the handle is mechanically

attached to the contraceptive device

by the elongate body by threads,

cooperating key/slots, connectors, or

the like”

Claim 14: “a deployment shaft

having a proximal end and a distal end

that is configured to mechanically

attach and detach from the

contraceptive device by threads,

cooperating key slots, connectors, or

the like”

Conceptus argues that “coupled” in both phrases means that the various components of the

invented apparatus are simply “paired to or joined with” each other. Hologic, by contrast, asserts

that when particular parts of the invention are “coupled” to each other, they must be

“mechanically attached” using “threads, cooperating key/slots, connectors, or the like.” As

explained below, neither construction seems entirely correct.

The claims themselves provide guidance as to the meaning of the term “couple.” For

example, the method in claim 5 covers an apparatus having a handle with “an actuator,” where

manipulation of the actuator retracts a protective sheath surrounding the contraceptive device. 

Similarly, in the apparatus covered by claim 14, “movement” of an “actuator mounted on the

handle . . . releases the contraceptive device from the . . . deployment shaft.” 

This “handle” and “actuator” are easi

ly visualized by two disclosed embodiments sho

wn below in FIGS. 7 and 11J.

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As shown in FIG. 7, the handle (denoted by 30) may contain numerous actuators (denoted

by 33 and 39) that perform different actions once the contraceptive device is properly positioned

within the fallopian tube. These actions may include the release of the contraceptive device from

the installation apparatus or retraction of a protective sheath around the contraceptive device (col.

8:47–64). FIG. 11J shows an alternative embodiment of such a handle being held by the user, and

illustrates how the actuators can moved (in this particular embodiment, the thumb rotates the

actuator). To show how the handle fits in with the entire apparatus, an exemplary embodiment of

the complete apparatus is shown below in FIG. 1B. 

As seen in FIG. 1B above, the handle (denoted as 30) is only one component of the entire

installation apparatus. On the opposite end of the apparatus is the contraceptive device (denoted

by 12). Connecting the handle and contraceptive device to each other are various components,

including a protective sheath (14), a release catheter (16), and a core shaft (18). Important to this

order, however, is the fact that the various components are interconnected as to allow the

actuators on the handle to retract the sheath (claim 5) or release the device within the fallopian

tube (claim 14).

In light of this intrinsic evidence, it is clear that the term “coupled” as used in the asserted

claims means something more than the components of the apparatus being simply “paired to or

joined with” each other, as proposed by Conceptus. A person having ordinary skill in the relevant

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art at the time the patent was filed — after reading the entire patent — would have understood the

term “coupled” as used in the asserted claims as requiring a more interactive connection. Stated

differently, the components of the device must be “coupled” together in a way that allows the

actuator(s) on the handle to trigger activity elsewhere on the device. This is the principal object

of the invention (col. 2:32–34).

The claims themselves, however, do not limit or describe how this interactivity between

components of the invention must be achieved. Nevertheless, Hologic argues that the

components of the invention must be “mechanically attached” to each other using “threads,

cooperating key/slots, connectors, or the like.” This construction of the term “coupled” was taken

directly from the description of one particular embodiment of the present invention (see col.

10:30–33). 

Hologic’s proposed construction, however, is too limiting. While it is true that the

specification only disclosed embodiments featuring mechanical attachments between the various

components of the invention, a person having ordinary skill in the relevant art at the time the

patent was filed would have understood that the required interactivity between various

components could have been achieved by mechanical or electronic means. For example, nothing

in the claims limit the “actuators” on the handle of the apparatus from being digital (i.e., based on

electronic circuitry) rather than mechanical. Pressing this button could send an electronic signal

to the deployment shaft or contraceptive device, triggering the mechanical retraction of the sheath

(in claim 5) or release of the device (in claim 14). Indeed, claim 14 also expressly covers an

apparatus that can administer RF energy to a portion of the fallopian tube (to promote scar tissue

formation). A person having ordinary skill in the relevant art at the time the patent was filed

would have understood that triggering this RF energy would likely involve electronic, rather than

mechanical, actuation.

In light of this analysis, this order finds that a person having ordinary skill in the relevant

art at the time the patent was filed would have understood “coupled” in claims 5 and 14 to allow

for the components of the apparatus to be mechanically or electronically connected to each other. 

Accordingly, the following constructions will govern: 

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The phrase “the handle coupled to the contraceptive device by an elongate body” from

claim 5 will be construed as “the handle mechanically and/or electronically connected to the

contraceptive device by the elongate body.” Similarly, the phrase “a deployment shaft having a

proximal end and a distal end releasably coupled to the contraceptive device” from claim 14 will

be construed as “a deployment shaft having a proximal end and a distal end that is mechanically

and/or electronically configured to attach to and detach from the contraceptive device.”

CONCLUSION

The constructions set forth above will apply in this dispute. The Court will reserve the

authority, on its own motion, to modify these constructions if further evidence warrants such a

modification. Additionally, the parties may file BY NOON ON FRIDAY, MARCH 19, 2010, a fivepage critique (double-spaced, no footnotes, and no attachments) limited to the points of critical

concern. In light of the voluminous briefing already submitted and the lengthy hearing on these

matters, this is an opportunity for the parties to focus solely on their most cogent critique.

IT IS SO ORDERED.

Dated: March 16, 2010. 

WILLIAM ALSUP

UNITED STATES DISTRICT JUDGE

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