Court Opinion

ID: 211530
Source: CourtListenerOpinion
Date Created: 2011-03-13 08:28:34+00
Date Added: 2024-06-11T17:28:06.933743
License: Public Domain

NOTE: Pursuant to Fed. Cir. R. 47.6, this disposition is not
                     citable as precedent. It is a public record.

 United States Court of Appeals for the Federal Circuit
                                        05-1126

                                  JOSEPH GRAYZEL,

                                                          Plaintiff-Appellant,

                                            v.

          ST. JUDE MEDICAL, INC., ST. JUDE MEDICAL, DAIG DIVISION, INC.,
                        and ST. JUDE MEDICAL S.C., INC.,

                                                         Defendants-Appellees.

                            __________________________

                            DECIDED: December 23, 2005
                            __________________________

Before MICHEL, Chief Judge, SCHALL and GAJARSA, Circuit Judges.

MICHEL, Chief Judge.

      Dr. Joseph Grayzel (“Grayzel”) appeals the United States District Court for the

District of New Jersey’s grant of summary judgment of invalidity of claims 13, 14, and 16

of U.S. Patent No. 4,850,960 (“the ’960 patent”) in favor of St. Jude Medical, Inc., St.

Jude Medical S.C., Inc., and St. Jude Medical, Daig Division, Inc. (collectively, “St.

Jude”).    Grayzel v. St. Jude Med., Inc., No. 01-CV-3737 (D.N.J. Oct. 29, 2004)

(“Summary Judgment Decision”). Grayzel also appeals the district court’s grant of an

injunction to enforce a protective order entered into by the parties during the course of

discovery.   Because we agree with the district court’s construction of the “sheath,”

“flexible,” and “uniformly-thin” claim limitations and its finding that the prior art
anticipates each and every limitation of claim 13 of the ’960 patent, we affirm the

summary judgment of invalidity. We further hold that the district court’s grant of an

injunction enforcing the protective order is moot as to claims 13, 14, and 16 and affirm

as to claims 1-12, 15, and 17-26.

                                   I.     BACKGROUND

                              A.        The Asserted Patent

       In 1953, Dr. Sven Seldinger developed a new percutaneous technique for

introducing a catheter into a patient’s blood vessel. See Sven Seldinger, “Catheter

Replacement of the Needle in Percutaneous Arteriography: A New Technique,” Acta

Radiologica 39: 368-76 (1953). His technique, which became known as the “Seldinger

technique,” involved: (1) inserting a hollow needle through the skin; (2) puncturing the

blood vessel with the needle; (3) inserting a guidewire through the bore of the needle

into the vessel; (4) removing the needle, leaving the guidewire in the vessel;

(5) advancing a catheter over the guidewire into the vessel; and (6) removing the

guidewire, leaving the catheter in the vessel through which a cardiologist may insert

diagnostic and therapeutic devices. Prior to the “Seldinger technique,” a doctor cut an

incision in the skin and artery and then inserted the desired catheter.

       In 1965, Drs. Donald Desilets and Richard Hoffman improved the Seldinger

technique.    See Donald T. Desilets & Richard Hoffman, “A New Method of

Percutaneous Catheterization,” Radiology 85: 147-48 (1965).           They introduced a

thin-walled, flexible sheath on top of the catheter and inserted that unit into the vessel

as described above. The catheter was, however, removed along with the guidewire,

leaving only the sheath in the vessel to act as a channel through which multiple devices

05-1126                                       2
could be inserted and removed without having to pass each new device over a

reinserted guidewire.    This technique became known as the “modified Seldinger

technique.” Notably, because both the catheter and the sheath contained blunt or flat

tips, considerable force was needed to insert the sheath-covered catheter into the

vessel. That force often caused tearing and trauma at the puncture site.

       In July of 1987, Grayzel filed a patent application claiming an improvement to the

modified Seldinger technique. Specifically, he disclosed using a beveled tip at the end

of the sheath, as shown in the figure below, to reduce the force needed to insert the

sheath-covered catheter and to avoid traumatizing the insertion site. See ’960 patent,

col. 2, ll. 43-58.

’960 patent, fig. 9. The beveled tip is indicated by the number 15 with the leading point

shown as number 4 and rearmost point shown as number 3. The catheter is designed

number 6 with the distal portion shown as number 5 and cylindrical section leading to

the beveled tip shown as number 9.

       This application issued as the ’960 patent in July of 1989. Independent claim 13

recites:

       13.     [1] A sheath of a size for use in the vascular system for assisting in
       the insertion of other devices in blood vessels through the wall of the
       blood vessel, said sheath comprising:
       [2] a flexible catheter for use in the vascular system;
       [3] said sheath having a flexible uniformly thin walled cylindrical shell body
               portion having a bore therethrough and a distal end and a proximal

05-1126                                      3
              end, said bore constructed to coact with and be supported by said
              flexible catheter extending within the bore;
       [4] a bevelled tip portion formed on the distal end of said sheath, said
              bevelled tip being formed at an acute angle with respect to the
              longitudinal axis of said tubular portion, to facilitate entry into an
              existing puncture in the wall of a blood vessel.

’960 patent, col. 11, ll. 61-68 (emphases added) (underlined text shows disputed

limitations; bracketed numbers reflect district court’s designation of claim limitations).

                                   B.      The Prior Art

       Two years before Grayzel filed his application, Dr. S. Murthy Tadavarthy and

others published an article describing a percutaneous technique for introducing a filter

into the inferior vena cava to snare blood clots (“Tadavarthy Article”). See S. Murthy

Tadavarthy, “Kimray-Greenfield Inferior vena cava Filter: Percutaneous Introduction,”

Radiology 151: 525-26 (May 1984). The article disclosed a blood vessel dilation system

having four parts: (1) a guidewire; (2) an 8 French dilator; (3) a 24 French dilator; and

(4) a 24 French Teflon tube that fits over the 24 French dilator.1 The article explained

that after the two dilators and tube are inserted percutaneously into a patient’s inferior

vena cava by way of the guidewire, the dilators are removed, leaving the tube in

position.   It further explained that a Kimray-Greenfield filter may be placed into a

patient’s inferior vena cava through the tube to catch loose blood clots.

       1
             The term “French” is a measurement for the diameter of tubular
instruments and is equal to 0.013 inches. See McGraw Hill Dictionary of Scientific
& Technical Terms 646 (3d ed. 1984).

05-1126                                       4
                           C.      The District Court Decision

       In August of 2001, Grayzel filed a patent infringement action against St. Jude,

alleging that St. Jude’s Angio-Seal vascular closure device infringes independent claim

13 and dependent claims 14 and 16 of the ’960 patent.2

       During the course of discovery, St. Jude identified numerous prior art references

that were not disclosed during the prosecution of the ’960 patent. Grayzel in turn filed a

request for an ex parte reexamination with the U.S. Patent and Trademark Office

(“PTO”) for claims 13, 14, and 16, and moved to stay the district court action pending

reexamination. The PTO granted Grayzel’s request for reexamination not just for claims

13, 14, and 16 as requested, but also for claims 1-12, 15, and 17-26. The district court

denied Grayzel’s motion to stay the litigation.

       In response, St. Jude filed a motion for an injunction to enforce the protective

order entered by the district court at the start of the litigation to bar both Grayzel and his

litigation counsel from participating in the ex parte reexamination. That protective order

identified two classes of information: (1) “Confidential Information;” and (2) “Attorneys’

Eyes Only Information.”     Under the terms of the order, Grayzel had access to the

Confidential Information, but not the Attorneys’ Eyes Only Information.           His use of

Confidential Information was, however, restricted such that he could not use it “for any

purpose other than in connection with [the] litigation.”        The protective order also

contained a so-called “prosecution bar” provision, which prohibited any person “who

       2
               Claim 14 is drawn to the invention of claim 13 wherein “visible indicia are
provided along the length of the sheath to indicate the position of the tip of the beveled
end.” ’960 patent, col. 12, ll. 8-10. Claim 16 is drawn to the invention of claim 1, 2, 3, or
13 wherein visible indicia are provided on the body portion of the catheter to indicate the
orientation of the bevel. Id., col. 12, ll. 16-18.

05-1126                                       5
ha[d] come into the possession of Attorney’s [sic] Eyes Only Information” from “any

involvement in the prosecution of” the ’960 patent.           That same provision likewise

specifically stated: “Joseph Grayzel understands the terms of this Protective Order

limiting the use of CONFIDENTIAL INFORMATION and ATTORNEY’S [sic] EYES

ONLY INFORMATION only for purposes in connection with this litigation and that no

patent application can be filed or prosecuted at any time based on CONFIDENTIAL

INFORMATION or ATTORNEY’S [sic] EYES ONLY INFORMATION produced by St.

Jude or Daig in this litigation.” The district court referred the injunction motion to a

magistrate judge for resolution.

       Following briefing and a two-day hearing, the magistrate judge recommended

barring Grayzel and his counsel from participating in the ex parte reexamination. The

magistrate judge reasoned that the “entire tenor of the protective order was to protect

information within the four corners of this litigation and not to allow discovery that is

confidential to be used for outside purposes.” The district court adopted the magistrate

judge’s recommendation and granted St. Jude’s motion for an injunction to enforce the

protective order. Grayzel v. St. Jude Med., Inc., No. 01-CV-3737 (D.N.J. Dec. 4, 2003).

       In March of 2003, St. Jude filed a motion for summary judgment of invalidity due

to anticipation under 35 U.S.C. § 102 and obviousness under 35 U.S.C. § 103. The

district court issued its claim construction and granted summary judgment in favor of St.

Jude in October of 2004. It held that claim 13 of the ’960 patent was anticipated by the

Tadavarthy Article as well as two other prior art references.             Summary Judgment

Decision, slip op. at 16-19. The district court also held that claims 14 and 16 were

obvious in light of other prior art references. Id., slip op. at 20-25.

05-1126                                        6
       With particular regard to anticipation of claim 13 by the Tadavarthy Article, the

district court first found that

       the sheath picture in the article’s diagram is clearly a “tubular member . . .
       used for accessing the vascular system through the skin and through
       which other devices . . . can be passed,” and it is obviously “thin-walled”
       and “flexible enough for use in the vascular system.” As the very title of
       the article demonstrates, this sheath is being inserted percutaneously into
       the vena cava. A device, specifically a so-called “Greenfield filter,” is
       passed through the sheath following removal of the introducing catheters.

Id., slip op. at 18-19. It consequently concluded that the Tadavarthy Article teaches

limitations [1] and [3] of claim 13. Next, the district court found that “the article shows an

introducing catheter that visibly bends and is inserted into the vena cava, thus rendering

it, by definition, flexible enough for use in the vascular system.” Id., slip op. at 19. As

such, it concluded that the Tadavarthy Article also teaches limitation [2] of claim 13.

Finally, the district court found that the Tadavarthy Article “clearly reveals a sheath with

a ‘sloped edge’ that would facilitate vein entry,” thereby disclosing limitation [4] of claim

13. Id.

       Grayzel timely appeals the district court’s claim construction, its grant of

summary judgment on anticipation grounds as to claim 13, and its grant of an injunction

enforcing the protective order.3 We have jurisdiction to consider the appeal pursuant to

28 U.S.C. § 1295(a)(1).

       3
              Grayzel does not challenge the district court’s invalidity ruling on
obviousness grounds as to claims 14 and 16. He merely asserts those claims are not
invalid because they depend from claim 13. The district court did not, however, hold
claims 14 and 16 anticipated. Consequently, we shall not address Grayzel’s argument
regarding claims 14 and 16.

05-1126                                       7
                                    II.        DISCUSSION

                               A.         Claim Construction

       Because claim construction is purely a matter of law, Markman v. Westview

Instruments, Inc., 52 F.3d 967, 970-71 (Fed. Cir. 1995) (en banc), we review the district

court’s claim construction de novo. Cybor Corp. v. FAS Techs., Inc., 138 F.3d 1448,

1454 (Fed. Cir. 1998) (en banc). In interpreting claims, a court’s primary focus should

be on the intrinsic evidence of record, i.e., the patent itself, including the claims, the

specification, and, if in evidence, the prosecution history. See Phillips v. AWH Corp.,

415 F.3d 1303, 1312-17 (Fed. Cir. 2005) (en banc).

       Grayzel argues that the district court misconstrued the “sheath,” “flexible,” and

“uniformly” limitations found in claim 13 of the ’960 patent.4 We consider each of his

arguments in turn.

                                          1.     Sheath

       The district court framed the dispute surrounding the “sheath” limitation as

“whether the sheath described has a particular size range,” ultimately concluding that it

did not. Summary Judgment Decision, slip op. at 8. It thus construed the term to mean

“any tubular member of any size that can be used for accessing the vascular system

through the skin and through which other devices and elements can be passed.” Id.

Grayzel asserts that the district court erroneously relied on a dictionary definition to

       4
                Grayzel also argued that the district court misconstrued the limitation
“visible indicia are provided along the length of the sheath to indicate the position of the
tip of the beveled end” of claim 14 to mean “visible indicia extending from the beveled
tip portion to indicate the catheter’s position in the vein.” Summary Judgment Decision,
slip op. at 15. The district court’s construction of this limitation does not impact the
resolution of this appeal since Grayzel does not properly raise any challenge with
respect to claim 14. We thus need not address Grayzel’s argument.

05-1126                                          8
trump both the intrinsic and extrinsic record in rendering its construction. He contends

that the correct construction for the “sheath” limitation, based upon the intrinsic record,

is “a SDH sheath for use in the SDH technique.”             For support, he relies on the

“Summary and Objects of the Invention” section, which he argues describes the

introducing catheter and sheath as an assembly used in the SDH technique at least

sixteen times.    He also relies on the prosecution history, in particular a statement

Grayzel made in response to an office action disclosing that “[b]asically, the present

invention sets forth an introducing catheter and/or sheath having a beveled end.”

       We disagree with Grayzel.        The ’960 patent uses the term “sheath” in the

ordinary sense of the word. First, as the district court noted, claim 13 recites that the

“sheath” is “of a size for use in the vascular system for assisting in the insertion of other

devices in blood vessels through the wall of the blood vessel.” Second, as St. Jude

points out, the specification expressly defines the term “sheath” as “[a] thin-walled outer

tubular member” through which an operational catheter is inserted into the blood vessel.

’960 patent, col. 1, ll. 58-59, 67-68. While that definition is disclosed in the “Background

of the Invention” section of the specification in the context of describing the prior art,

Grayzel does not depart from it when describing his invention.             For example, the

specification states in the context of describing figures 12, 13, and 14:          “Once the

sheath is in place, with entry to the lumen of the blood vessel properly dilated and the

opening is secured, the introducing catheter 506 and the guide wire 514 can be

removed leaving the sheath in place to allow for entry of the various devices that will

then be placed into the blood vessel.” ’960 patent, col. 10, ll. 17-22. Third, logically, it is

unlikely that Grayzel would have defined the term “sheath” distinct from the prior art

05-1126                                       9
because his invention did not radically depart from the modified Seldinger technique.

Rather his invention involved an improvement over the prior art wherein he simply

terminated the tip of the prior art sheath at an angle to facilitate entry through the

puncture site.

       Given that the term “SDH sheath” does not appear anywhere in the ’960 patent

or its prosecution history, we suspect that Grayzel likely coined the term for purposes of

this appeal. Indeed, the statements in the specification and prosecution history relied

upon by Grayzel do not actually support his proffered construction. Instead, we read

those statements to be consistent with an ordinary definition for the term as accorded by

the district court. Additionally, we note that before the district court Grayzel argued only

in favor of limiting the definition of “sheath” to a particular size range, numerical limits

which the district court correctly found are not present in the intrinsic record. Grayzel

did not advocate below that the term “sheath” means “SDH sheath.” Accordingly, we

agree with the district court’s construction of the term “sheath” to mean “any tubular

member of any size that can be used for accessing the vascular system through the

skin and through which other devices and elements can be passed.”

                                      2.     Flexible

       The district court construed the term “flexible” to mean “flexible enough for use in

the vascular system as a conduit for an introducing catheter and other devices.”

Summary Judgment Decision, slip op. at 12. Grayzel argues that such a construction

“reverses the relationship between the SDH sheath and the introducing catheter in the

SDH apparatus.” The sheath, he contends, does not act as a conduit for the introducing

catheter. Rather, Grayzel asserts that the introducing catheter enters the puncture site

05-1126                                     10
carrying the sheath and that the sheath would “bend, fray, or buckle” if unsupported by

an introducing catheter. Grayzel relies on the language of claim 13, which recites that

the sheath “coacts with” and is “supported by” the introducing catheter, to support his

contention. Hence, he advocates that the correct construction for the term “flexible” is

“sufficiently flexible such that the sheath must be carried into the vessel wall puncture

by the introducing catheter” and “would bend, fray, or buckle if it were introduced into

the puncture site without the benefit of being carried in by the introducing catheter.”

       Grayzel’s proposed construction is not consistent with the intrinsic record. The

specification makes clear that the sheath may be supported by the catheter, but that it is

not required to be.    The specification states in the “Summary and Objects of the

Invention” section: “After insertion of the catheter, the sheath can be inserted by sliding

it over the catheter if the sheath is not already on the body of the catheter.” ’960 patent,

col. 5, ll. 34-36 (emphasis added). Contrary to Grayzel’s argument, this disclosure

suggests that the introducing catheter may be inserted first followed by the sheath.

Once inside the vessel, the sheath will be slid onto the introducing catheter so that the

two are positioned in the vessel as a single unit. The specification does not caution that

the sheath may “bend, fray, or buckle” if introduced without the support of the

introducing catheter. Nor does it disclose that special care is necessary when handling

an independent sheath. Alternatively, this disclosure suggests the way that St. Jude

apparently contemplates for inserting the introducing catheter and sheath under the

’960 patent, specifically, that the sheath may be placed over the introducing catheter at

the outset and the two are inserted and positioned into the vessel as a single unit.

05-1126                                     11
       Significantly, either approach is consistent with the language of claim 13, which

merely states that the bore of the sheath will “coact with” and “be supported by the said

flexible catheter.” This language does not proscribe that such coaction and support

exist before the sheath is inserted into the vessel. Grayzel plainly misapprehends this

language in arguing otherwise.        Hence, because the specification teaches two

approaches for inserting the sheath into a vessel, one where the sheath is independent

of an introducing catheter, we conclude that the district court correctly construed the

“flexible” limitation simply as “flexible enough for use in the vascular system as a conduit

for an introducing catheter and other devices.”

                                     3.     Uniformly

       The district court construed the term “uniformly” as “always the same” or

“unvarying.”    Summary Judgment Decision, slip op. at 13.        Grayzel challenges this

construction, arguing that the correct construction is “without fluctuation or variation;

consistent.”    Grayzel is splitting hairs in arguing that the district court should have

selected the definition “without fluctuation or variation; consistent” instead of the

definition “always the same; unvarying” for the term “uniformly.” The district court’s

definition is synonymous with Grayzel’s proposed definition.            See The Oxford

Thesaurus 561 (Am. ed. 1992) (“consistent” and “unvaryingly” listed as synonyms for

the adjective “uniform”). Moreover, either definition conveys that the walls of the sheath

are thin for the entire length of the sheath. As such, we conclude that the district court

did not err in construing the “flexible” limitation to mean “always the same” or

“unvaringly.”

05-1126                                     12
                                   B.     Anticipation

       We review the grant of summary judgment de novo, reapplying the same

standard as the district court. Knoll Pharm. Co., Inc. v. Teva Pharms. USA, Inc., 367

F.3d 1381, 1384 (Fed. Cir. 2004). Summary judgment is appropriate when there are no

genuine issues of material fact or when the non-movant cannot prevail on the evidence

submitted when viewed in a light most favorable to it. Id. “When ruling on a motion for

summary judgment, all of the non-movant’s evidence is to be credited, and all justifiable

inferences are to be drawn in the non-movant’s favor.” Id. (quoting Caterpillar Inc. v.

Deere & Co., 224 F.3d 1374, 1379 (Fed. Cir. 2000)). A claim is anticipated under § 102

“if each and every limitation is found either expressly or inherently in a single prior art

reference.” Bristol-Myers Squibb Co. v. Ben Venue Labs, Inc., 246 F.3d 1368, 1374

(Fed. Cir. 2001).

       Grayzel argues that the district court erred in holding that the Tadavarthy Article

anticipates claim 13 of the ’960 patent because it fails to disclose a “catheter” and a

“sheath” as set forth in claim 13. As to the former, he contends that the neither the 8

French dilator nor the 24 French dilator discussed in the Tadavarthy Article serve as a

“catheter” because they do not function to “introduce” diagnostic tools into a patient’s

vessel by expanding the puncture site. Instead, the 8 French dilator, he claims, serves

a “diagnostic” purpose because it allows an inferior cavogram to be taken by a

diagnostic catheter once that catheter is positioned in the inferior vena cava. Similarly,

he maintains that the 24 French dilator also serves a “diagnostic” purpose because it

expands the inferior vena cava to allow deliver of the Kimray-Greenfield filter. Grayzel

also asserts that the Tadavarthy Article teaches that the 24 French dilator is made of a

05-1126                                     13
stiff material and thus not flexible. He points out that claim 13, by contrast, requires the

“catheter” to be “flexible.”

       Turning to the “sheath” limitation, Grayzel argues that the Tadavarthy Article

does not disclose a “sheath” as required by claim 13 because the 24 French Teflon tube

discussed in that reference is both too large and too rigid. For support, Grayzel relies

on the testimony of his expert, Dr. David Eckmann, who explained in his declaration that

“SDH sheaths” are normally much smaller than 24 French, and that he compared the

representative flexibility of the claimed “SDH sheath” with that of the 24 French Teflon

tube and found that the latter was 30 times more rigid. Grayzel also relies on three

articles published by Dr. Wilfrido Castaneda-Zuniga wherein Dr. Castaneda referred to

the Teflon tube used in conjunction with dilators as being “stiff.” Additionally, Grayzel

asserts that Tadavarathy Article does not disclose that the 24 French Teflon tube is

“uniformly thin-walled” as required by claim 13.      He contends that the district court

merely speculated that this limitation was found in the Tadavarthy Article, stating that

the “[24 French Teflon tube] is obviously thin-walled,” Summary Judgment Decision, slip

op. at 18, without conducting a proper anticipation analysis for that claim limitation.

       St. Jude responds by asserting that the district court correctly found that the

Tadavarthy Article discloses at least one “catheter” and a “sheath.” St. Jude contends

that either the 8 French dilator or the 24 French dilator qualifies as a “catheter” because

they both expand the puncture site, even though they may also serve other purposes. It

also contends that the 24 French Teflon tube is a “sheath” as claimed in claim 13. The

size of the tube, St. Jude argues, is of no import because it is not a specific claim

limitation. Moreover, St. Jude advocates that the 24 French Teflon tube is necessarily

05-1126                                      14
flexible because it is inserted percutaneously into the vascular system via either the

jugular vein in the neck or the femoral vein in the leg and navigated to the inferior vena

cava without causing any internal damage. Finally, St. Jude maintains the Tadavarthy

Article plainly illustrates that the “sheath” is “uniformly thin-walled.” As such, it argues

that the district court correctly found that the Tadavarthy Article anticipates each and

every limitation of claim 13 of the ’960 patent.

       We agree with St. Jude that the Tadavarthy Article anticipates claim 13. First, as

the district court correctly found, the 24 French dilator disclosed in the Tadavarthy

Article operates as a “catheter” as set forth in claim 13.       The 24 French dilator is

inserted into either the jugular or femoral vein via a guidewire and carries the 24 French

Teflon tube with it to the inferior vena cava, exactly like the claimed “catheter.” That the

24 French dilator simultaneously expands the jugular or femoral vein and inferior vena

cava to allow the Kimray-Greenfield filter to enter is immaterial. The language of claim

13 does not limit the function of the claimed “catheter” to only introducing a “sheath.” In

fact, claim 13 does not prescribe any specific function for the “catheter.” Moreover, as

pointed out by St. Jude, neither the specification nor the prosecution history of the ’960

patent limits the function of the “catheter.” If anything, the specification actually appears

to recognize that the introducing catheter offers more than one function: “A further

object of the present invention is to provide an introducing catheter which separates the

entry function of the catheter from the dilation function of the catheter.” ’960 patent, col.

3, ll. 34-36 (emphases added).

       Second, although the Tadavarthy Article does not explicitly address whether the

24 French dilator is flexible, it does so implicitly by virtue of the fact that the 24 French

05-1126                                      15
dilator is inserted via either the jugular or femoral vein and delivered to the inferior vena

cava, some internal distance away from the puncture site. If the 24 French dilator was

rigid, then it would be difficult to maneuver it through the vascular system around

internal organs to position it in the inferior vena cava. Indeed, the Tadavarthy Article

specifically recognizes the difficulty in accessing the inferior vena cava stating that it is

preferable to reach it via the transjugular approach through the neck rather than by the

transfemoral approach through the leg. Accordingly, we conclude that the Tadavarthy

Article discloses a “catheter” as claimed in claim 13.

       Third, the district court correctly found that the 24 French Teflon tube disclosed in

the Tadavarthy Article operates as the claimed “sheath.”           The Tadavarthy Article

teaches that the 24 French Teflon tube is placed over the 24 French dilator and inserted

into the inferior vena cava, precisely as the claimed “sheath” is positioned over the

claimed “catheter” and inserted into a blood vessel. Grayzel’s argument that the 24

French Teflon tube is too large to qualify as the claimed “sheath” is unavailing. Claim

13 does not place any numerical restriction on the size of the claimed “sheath,” and it

stands to reason, as St. Jude acknowledges, that sheath size varies with blood vessel

size. Grayzel’s argument that the 24 French Teflon tube is too rigid to qualify as the

claimed “sheath” is equally unavailing. As discussed above, the 24 French Teflon tube

implicitly must be “flexible” for the same reason that the claimed “sheath” is flexible.

That is, the 24 French Teflon tube travels atop the 24 French dilator through either the

jugular or femoral vein to be positioned in the inferior vena cava. If the 24 French dilator

was rigid as asserted by Grayzel, it is unlikely that it could be routed through the

vascular system around various internal organs. Moreover, Figure 2 in the Tadavarthy

05-1126                                      16
Article shows the 24 French Teflon tube in a bent position upon removal from the

jugular vein after insertion of the Kimray-Greenfield filter.

       Furthermore, Grayzel’s reliance on the three Castaneda articles is misplaced.

The “stiff” sheaths discussed in those articles were inserted via the ureter into a kidney

to remove kidney stones; they were not inserted into a blood vessel like the sheath

employed in the ’960 patent. This functional difference explains why those sheaths

were of a more rigid nature than the claimed “sheath.” Indeed, one of the articles

explains that the stiffness was needed to prevent the dilator from buckling at the renal

capsule, which was a common problem in renal dilation systems. Grayzel thus takes

Dr. Castaneda’s statements about the sheath out of context in asserting that they apply

to the claimed “sheath.”

       Fourth, while Grayzel is correct that the Tadavarthy Article does not explicitly

state that the 24 French Teflon tube is “uniformly thin-walled,” it inherently must be

because the size is set at 24 French. The diameter therefore must be “unvarying” or

“always the same” for the entire length of the tube. Moreover, the dilator over which the

Teflon tube fits is 24 French in diameter. If the Teflon tube were of varying diameter

along the length or of a diameter that increased or decreased, respectively, from the

beveled tip to the far end, then the tube either potentially would not fit atop the dilator

and/or would not remain in position through the insertion process.        Hence, like the

district court, we conclude that the Tadavarthy Article implicitly discloses a “uniformly

thin-walled sheath” as claimed in claim 13.

       In sum, because the Tadavarthy Article discloses each and every limitation of

claim 13 of the ’960 patent, we hold that it anticipates claim 13 and thereby renders it

05-1126                                       17
invalid under § 102. As such, we need not decide whether the district court correctly

found that the remaining two references also anticipate claim 13.

                    C.    Injunction to Enforce the Protective Order

       Grayzel argues that the district court erred in barring him from participating in the

ex parte reexamination of the ’960 patent based upon the “prosecution bar” provision of

the protective order.5 That provision, he contends, does not apply to him for three

specific reasons.    First, Grayzel asserts both that it applies only to recipients of

Attorneys’ Eyes Only Information and that he is not such a recipient.          Second, he

asserts that it applies only to applications either corresponding to the ’960 patent or

related to the subject matter of the ’960 patent, but not to the ’960 patent itself. Third,

he asserts that the “prosecution bar” provision does not name a reexamination as a

prohibited proceeding.

       In response, St. Jude asserts that we need not review Grayzel’s challenge to the

district court’s order issuing an injunction to enforce the protective order because

Grayzel only appealed the final judgment granting St. Jude’s motion for summary

judgment based on invalidity. Moreover, the district court’s order, St. Jude argues, is

not an interlocutory decision with substantial connection to the summary judgment of

invalidity such that it merged into that judgment. Rather, it claims that the district court

granted the injunction to protect its confidential information; such protection is in no way

related to the validity of the ’960 patent. Even if Grayzel had properly appealed the

district court’s ruling, St. Jude contends that Paragraphs 15 and 19 of the protective

order expressly prevent Grayzel from using protected information, except in the litigation

       5
              Grayzel does not challenge the district court’s order as to his litigation
counsel.

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itself. Accordingly, it maintains that the district court did not abuse its discretion in

enforcing the protective order against Grayzel.

       Grayzel’s challenge to the district court’s issuance of an injunction enforcing the

protective order is not simple and involves dividing the claims subject to reexamination

into two groups, namely, (1) claims 13, 14, and 16, which were subject to the St. Jude

litigation, and (2) claims 1-12, 15, and 17-26, which were not. As to the former group,

we need not reach the merits of Grayzel’s appeal in view of Manual of Patent Examining

Procedure § 2286.      That section requires the PTO to terminate a reexamination

proceeding where the Federal Circuit has issued a final decision holding that the claims

subject to reexamination are invalid. Specifically, “[u]pon the issuance of a final holding

of invalidity or unenforceability, the claims held invalid or unenforceable will be

withdrawn from consideration in the reexamination. The reexamination will continue as

to any remaining claims.” U.S. Pat. & Trademark Off., Manual of Patent Examining

Procedure § 2286 (8th ed. 2001, rev. May 2004). Here, Grayzel sought, and the PTO

granted, reexamination of claims 13, 14, and 16 of the ’960 patent. We hold that claim

13 is invalid under § 102 herein, and Grayzel failed to appeal the district court’s ruling

that claims 14 and 16 are invalid under § 103, thus waiving his rights to do so in the

future. Accordingly, we conclude that there can be no substantial new question of

patentability as to claims 13, 14, and 16 and that Grayzel’s challenge is moot as to

those claims.

       With respect to the latter group, claims 1-2, 15, and 17-26 were not implicated in

the St. Jude litigation. Nor were they listed in Grayzel’s request for reexamination. The

PTO, nevertheless, included them in its reexamination grant and has proceeded to

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consider the patentability of these claims in light of the prior art references disclosed by

Grayzel during the reexamination proceeding. We are, as a result, in the position of

having to decide the merits of Grayzel’s challenge to the issuance of an injunction

enforcing the protective order. In doing so, we apply the law of the regional circuit since

the nature of his challenge does not involve a patent issue. See Phonometrics, Inc. v.

Hospitality Franchise Sys., 203 F.3d 790, 793 (Fed. Cir. 2000).

       Federal Rule of Appellate Procedure 3(c) provides, in pertinent part, that a notice

of appeal “must designate the judgment, order or part thereof appealed from . . . .”

Fed. R. App. P. 3(c). If a party does not satisfy the requirements of this rule, then an

appellate court does not acquire jurisdiction over the undesignated judgment or order.

United States v. Rivera Constr. Co., 863 F.2d 293, 298 (3d Cir. 1988). Here, Grayzel

stated in his notice of appeal that he appeals “from the final judgment entered in this

action on November 8, 2004 granting defendant’s motion for summary judgment based

on invalidity of claims 13, 14 and 16 of U.S. Patent No. 4,850,960 and dismissing the

case.” Plainly, he did not mention the district court’s interlocutory order. Consequently

on first blush, it appears that the St. Jude may be correct that we lack appellate

jurisdiction.

       Nevertheless, the Third Circuit has opted to liberally construe notices of appeal.

Drinkwater v. Union Carbide Corp., 904 F.2d 853, 858 (3d Cir. 1990). It has, in fact,

held that it may properly exercise appellate jurisdiction over orders not specified in the

notice of appeal if “’there is a connection between the specified and unspecified order,

the intention to appeal the unspecified order is apparent and the opposing party is not

prejudiced and has a full opportunity to brief the issues.’” Lusardi v. Xerox Corp., 975

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F.2d 964, 972 (3d Cir. 1992) (quoting Williams v. Guzzardi, 875 F.2d 46, 49 (3d Cir.

1989)).    Here, we conclude that these three requirements are met.            First, Grayzel

procedurally could not appeal the district court’s interlocutory order until the district court

entered final judgment in favor of St. Jude. The Third Circuit has explained that an

appeal from a final judgment incorporates all prior non-final orders and rulings, since

only a final judgment or order is appealable. Drinkwater, 904 F.2d at 858 (citing Elfman

Motors, Inc. v. Chrysler Corp., 567 F.2d 1252, 1254 (3d Cir. 1977)).             To conclude

otherwise in this case would prevent Grayzel from ever challenging the district court’s

interlocutory ruling, and we do not think such an outcome comports with the Third

Circuit’s jurisprudence regarding Rule 3(c).       Because of this, we conclude that the

requisite connection exists. Second, Grayzel has clearly manifested his intent to appeal

the district court’s interlocutory order. He specifically raised this issue in clear terms in

both his opening and reply briefs. Third, St. Jude would not be prejudiced if we decide

this issue since it had the opportunity to fully respond to Grayzel’s challenge and has

done so.     Accordingly, contrary to St. Jude’s contention, we hold that we have

jurisdiction to review the district court’s interlocutory order granting an injunction to

enforce the protective order.

       The Third Circuit reviews the grant of injunctive relief under the abuse of

discretion standard. United States v. Bell, 414 F.3d 474, 478 (3d Cir. 2005). In the

disputed protective order, Paragraph 15 works together with Paragraph 19, the

so-called “prosecution bar” provision, to restrict the use of all Confidential and Attorneys’

Eyes Only Information involved in the litigation.         Read together, those provisions

expressly prohibit persons who come into possession of any such information from

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disclosing it outside of the litigation, regardless of the use.     Paragraph 19, in fact,

specifically discusses Grayzel’s use of the two kinds of protected information, stating

“Joseph Grayzel understands the terms of this Protective Order limiting the use of

CONFIDENTIAL INFORMATION and ATTORNEYS’ EYES ONLY INFORMATION only

for purposes in connection with this litigation . . . .” On this basis, we have no choice but

to conclude that Grayzel, who had access to Confidential Information, although not

Attorneys’ Eyes Only Information, falls squarely into the prohibitions set forth in

Paragraphs 15 and 19. Thus, he is plainly precluded from using any of the Confidential

Information he acquired through this litigation in any proceeding outside of the litigation,

such as the ongoing reexamination proceeding.

       Grayzel’s arguments regarding the scope of Paragraph 19 are unpersuasive. In

asserting that he is unaffected by the prohibition on the use of ATTORNEYS’ EYES

ONLY INFORMATION found in Paragraph 19, Grayzel mistakenly ignores Paragraph

15. Moreover, that Paragraph 19 only mentions applications corresponding to the ’960

patent or related subject matter and does not specifically list a reexamination

proceeding is of no consequence in the face of the express prohibition found in

Paragraph 15. Far from producing “Draconian results,” as asserted by Grayzel, the

district court’s order granting an injunction to enforce the protective order does nothing

more than effect the parties’ intent, just as the magistrate judge essentially

acknowledged in his recommendation. To allow Grayzel to escape the very provisions

he agreed to before learning of potentially invalidating prior art during discovery and

filing a request for reexamination would, we fear, render the protective order under

which discovery proceeded in this case meaningless. We, therefore, conclude that the

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district court did not abuse its discretion in granting the injunction to enforce the

protective order, and we affirm that grant.

                                  III.   CONCLUSION

       For the foregoing reasons, we affirm the summary judgment of invalidity of claim

13 under § 102, hold that the district court’s issuance of an injunction enforcing the

protective order is moot as to claims 13, 14, and 16, and affirm the district court’s order

granting an injunction to enforce the protective order as to claims 1-12, 15, and 17-26.

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