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- 1 - 08cv1512

UNITED STATES DISTRICT COURT

SOUTHERN DISTRICT OF CALIFORNIA

MEDTRONIC SOFAMOR DANEK USA,INC., et al,

Plaintiffs/Counterclaim Defendants,

CASE NO. 08cv1512-MMA(AJB)

vs. ORDER CONSTRUING DISPUTEDCLAIM TERMS OF UNITED STATESPATENT NOS. 5,860,973; 6,945,933;6,592,586; and 7,470,236NUVASIVE, INC.,

Defendant/Counterclaimant.

Pursuant to Markman v. Westview Instruments, Inc., 517 U.S. 370 (1996), the Court

conducted a hearing on February 25, 2010 regarding the construction of disputed claim terms in the

United States Patent Nos. 5,860,973; 6,945,933; 6,592,586; and 7,470,236. Attorneys Luke

Dauchot, Nimalka Wickramasekera, Jeff Schwartz, Jon Hangartner, and Rachel Walsh appeared on

behalf of Plaintiffs Medtronic Sofamor Danek USA, Inc., et al. Attorneys Todd Miller, Frank

Scherkenbach, Michael Engle, Steve Schaefer, Jonathan Spangler, and Rory Schermerhorn appeared

on behalf of Defendant and Counterclaimant NuVasive, Inc. Prior to the hearing, the Court provided

the parties with its tentative construction of each disputed claim term and instructed the parties to

meet and confer. After review, the parties agreed that certain terms merited further argument before

the Court and focused their presentations accordingly. Upon careful consideration of the papers and

the oral arguments of counsel, the Court issues the following order construing the disputed claim

terms of the patents at issue in this case.

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1 United States Patent Nos. 5,860,973 (the ‘973 Patent); 5,772,661 (the ‘661 Patent); 6,936,051 (the ‘051Patent); 6,936,050 (the ‘050 Patent); 6,916,320 (the ‘320 Patent); 6,945,933 (the ‘933 Patent); 6,969,390(the ‘390 Patent); 6,428,542 (the ‘542 Patent); and 6,592,586 (the ‘586 Patent). 2 United States Patent Nos. 7,207,949 (the ‘949 Patent); 7,470,236 (the ‘236 Patent); and 7,582,058 (the‘058 Patent).

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BACKGROUND

On October 6, 2008, Plaintiffs Medtronic Sofamor Danek USA, Inc., et al (“Medtronic”)

filed an amended complaint for infringement of nine patents against Defendant NuVasive, Inc.

(“NuVasive”).1 NuVasive has asserted counterclaims against Medtronic, including infringement of

three patents.2 Medtronic and NuVasive are medical product companies with a shared corporate

history. The patents-in-suit generally relate to implants, instruments, and methods used to treat the

human spine. The parties stipulated to phased litigation, therefore only the four patents selected for

the first phase of litigation are currently before the Court.

DISCUSSION

A. LEGAL STANDARD

The construction of patent claim terms is a matter of law for the court. Markman v.

Westview Instruments, Inc., 517 U.S. 370, 372 (1996). “It is a bedrock principle of patent law that

the claims of a patent define the invention to which the patentee is entitled the right to exclude.”

Innova/Pure Water, Inc. v. Safari Water Filtration Sys., 381 F.3d 1111, 1115 (Fed. Cir. 2004). As a

general rule, the claim language carries its ordinary and customary meaning. Toro Co. v. White

Consol. Indus., Inc., 199 F.3d 1295, 1299 (Fed. Cir. 1999). The ordinary meaning of a term cannot,

however, be construed in a vacuum; rather, a court “must look at the ordinary meaning in the context

of the written description and the prosecution history.” Medrad, Inc. v. MRI Devices Corp., 401

F.3d 1313, 1319 (Fed. Cir. 2005). To ascertain the meaning of a claim term, the court refers to

“those sources available to the public that show what a person of ordinary skill in the art would have

understood disputed claim language to mean.” Phillips v. AWH Corp., 415 F.3d 1303, 1314 (Fed.

Cir. 2005) (en banc). The court does so to “determine whether the inventor used any terms in a

manner inconsistent with their ordinary meaning.” Vitronics Corp. v. Conceptronic, Inc., 90 F.3d

1576, 1582 (Fed. Cir. 1996). The sources include “the words of the claims themselves, the

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remainder of the specification, the prosecution history, and extrinsic evidence concerning relevant

scientific principles, the meaning of technical terms, and the state of the art.” Phillips, 415 F.3d at

1314 (citing Innova, 381 F.3d at 1116).

The court begins with the language of the claims. PSC Computer Prods., Inc. v. Foxconn

Int’l, 355 F.3d 1353, 1359 (Fed. Cir. 2004). When considering the claim language, “the context in

which a term is used in the asserted claim can be highly instructive.” Phillips, 415 F.3d at 1314.

The court may also consider the other claims of the patent, both asserted and non-asserted. Id. For

example, as claim terms are normally used consistently throughout a patent, the usage of a term in

one claim may illuminate the meaning of the same term in other claims. Id. The court may also

consider differences between claims to guide in understanding the meaning of particular claim

terms. Id.

As the claims do not stand alone, they “must be read in view of the specification, of which

they are a part.” Phillips, 415 F.3d at 1315 (citing Markman v. Westview Instruments, 52 F.3d 967,

979 (Fed. Cir. 1995)). “The construction that stays true to the claim language and most naturally

aligns with the patent’s description of the invention will be, in the end, the correct construction.”

Renishaw PLC v. Marposs Societa’ per Azioni, 158 F.3d 1243, 1250 (Fed. Cir. 1998). When the

specification reveals a special definition given to a claim term by the patentee that differs from the

meaning it would otherwise possess, the inventor’s lexicography governs. Phillips, 415 F.3d at

1316 (citing CCS Fitness, Inc. v. Brunswick Corp., 288 F.3d 1359, 1366 (Fed. Cir. 2002)). The

specification may reveal an intentional disclaimer, or disavowal, of claim scope by the inventor. Id.

(citing SciMed Life Sys., Inc. v. Advanced Cardiovascular Sys., Inc., 242 F.3d 1337, 1343-44 (Fed.

Cir. 2001)).

The Federal Circuit also has affirmed the importance of the prosecution history. Phillips,

415 F.3d at 1317. The prosecution history represents an ongoing negotiation between the PTO and

the applicant. Id. The prosecution history, like the specification, “provides evidence of how the

PTO and the inventor understood the patent.” Id. (citing Lemelson v. Gen. Mills, Inc., 968 F.2d

1202, 1206 (Fed. Cir. 1992)). However, it is subject to inherent ambiguity because is represents the

negotiation, rather than the final product of the negotiation, and is thus less useful than the

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specification. Id.

Extrinsic evidence “can shed useful light on the relevant art,” but the Federal Circuit

considers it “less significant than the intrinsic record in determining the legally operative meaning of

claim language.” Id. (citing C.R. Bard, Inc. v. U.S. Surgical Corp., 388 F.3d 858, 862 (Fed. Cir.

2004)). “Extrinsic evidence may be useful to the court, but it is unlikely to result in a reliable

interpretation of patent claim scope unless considered in the context of the intrinsic evidence.” Id. at

1319. The Federal Circuit has held that it remains within the court’s discretion to admit extrinsic

evidence, provided the court keeps in mind the flaws inherent in extrinsic evidence. Id.

In sum, this Court first must interpret the claim terms in light of intrinsic evidence –

specification, claims, and prosecution history – and then exercise discretion in deciding whether to

consider extrinsic evidence submitted by the parties.

B. CONSTRUCTION OF DISPUTED CLAIM TERMS

With the above principles in mind, the Court turns to the construction of the disputed claim

terms. Where the disputed terms appear across claims, the Court’s constructions apply to all

instances of those terms unless otherwise indicated.

1. Medtronic U.S. Patent No. 5,860,973: Translateral Spinal Implant

The invention embodied in the ‘973 Patent is a spinal fusion implant that is sized for

insertion into the spine, in between vertebra, from the side of the patient, and then fused to the

patient’s spine. The invention claims to be an improvement over the prior art in two primary

respects. First, the ability to insert the implant by going in through the patient’s side is preferred to

the two methods relied upon by physicians previously – either going in through the patient’s front

side (requiring a second surgeon to be present in order to lift the patient’s organs out of the way) or

through the patient’s back side (requiring the surgeon to go through the spinal cord in order to place

the implant). Second, the implant itself is structured in such a way that it fits better between

vertebra and comes into contact with a greater amount of vertebral surface area, which means it

fuses better, moves with the body better, and is more stable once implanted.

a) Preambles to claims 1, 35, and 61

The parties dispute whether the second portions of the preambles to claims 1, 35, and 61

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limit those claims, or whether they serve only as a statement of intended use. Claims 1 and 35 share

the same preamble, which provides: “A translateral spinal implant for insertion from the lateral

aspect of the spine in the disc space between two adjacent vertebae.” The preamble of claim 61

provides: “A translateral spinal fusion implant for insertion from the lateral aspect of the spine in

the disc space between two adjacent vertebae.” NuVasive argues that “for insertion from the lateral

aspect of the spine in the disc space between two adjacent vertebrae,” in the preambles of claims 1,

35, and 61, recites language of intended use and does not limit the claims. The Court tentatively

found the preambles to be limiting.

“[T]here is no ‘litmus test’ for determining whether preamble language is limiting.” Bicon,

Inc. v. Straumann Co., 441 F.3d 945, 952 (Fed. Cir. 2006). A preamble simply stating the intended

use or purpose of the invention usually will not limit the scope of the claim, unless the preamble

provides antecedents for ensuing claim terms and limits the claim accordingly. Boehringer

Ingelheim Vetmedica, Inc. v. Schering-Plough Corp., 320 F.3d 1339, 1345 (Fed. Cir. 2003). A

preamble may operate as a claim limitation when the inventor uses it to recite structure that defines

the invention. Bell Commc’n Research, Inc. v. Vitalink Commc’n Corp., 55 F.3d 615, 620 (Fed. Cir.

1995).

Here, the preambles describe the invention, the implant, as one “for insertion from the lateral

aspect of the spine in the disc space between two adjacent vertebrae.” The key portion of the phrase

is “for insertion.” NuVasive argues that this is clearly a statement of intended use, while Medtronic

argues that it is a limitation on the claims. Preambles are not limiting “where a patentee defines a

structurally complete invention in the claim body and uses the preamble only to state a purpose or

intended use for the invention.” Id. (internal citation omitted); see Pitney Bowes, Inc. v. Hewlett

Packard Co., 182 F.3d 1298,1305 (Fed.Cir. 1999) (internal citations omitted) (“If, however, the

body of the claim fully and intrinsically sets forth the complete invention, including all of its

limitations, and the preamble offers no distinct definition of any of the claimed invention’s

limitations, but rather merely states, for example, the purpose or intended use of the invention, then

the preamble is of no significance to claim construction because it cannot be said to constitute or

explain a claim limitation.”).

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Claims 1, 35, and 61 fully set forth the structure of the invention; the preambles do not act as

a separate limitation. For example, after the preamble, claim 1 states “said implant having a length

that is greater than one half the transverse width of the vertebrae, said length being substantially

greater than the depth of the vertebrae, and a height for contacting each of the two adjacent

vertebrae.” A review of the ‘973 Patent’s prosecution history demonstrates that the dimensions of

the implant distinguished it from the prior art, not the inventor’s intended use of the implant. In

addition, “for insertion from the lateral aspect of the spine in the disc space between two adjacent

vertebae” does not add to the claimed structural limitations. “For insertion” suggests to a person of

ordinary skill in the art what the inventor intended for that person to do with the implant. “From the

lateral aspect of the spine” suggests how the inventor intended the implant to be inserted. “In the

disc space between two vertebrae” advises a person of ordinary skill in the art as to where the

implant is intended to be inserted. No part of the second portion of the preambles define the

structure of the implant. Therefore, upon further review, having considered the oral arguments of

counsel, the Court DECLINES to affirm its tentative ruling that the preambles limit claims 1, 35,

and 61. Rather, the Court finds that the preambles to claims 1, 35, and 61 recite a statement of

intended use.

b) translateral spinal implantc) translateral spinal fusion implant

In addition to the second portions of the preambles referenced above, the terms translateral

spinal implant, appearing in the preamble to claims 1 and 35, and translateral spinal fusion

implant, appearing in the preamble of claim 61, are also in dispute. Both parties offer proposed

constructions of these terms. The Court tentatively found that the word “translateral” has a plain

meaning to a person of ordinary skill in the art. As such, the Court determined that the terms do not

need to be construed. The Court also found the terms to be limiting. Having reviewed the

submissions and the oral arguments of counsel, and consistent with the Court’s finding that the

second portion of the preambles to claims 1, 35, and 61 do not add structural limitations to those

claims, the Court DECLINES to affirm its tentative ruling. Rather, the Court construes the term

translateral spinal implant to mean: “a spinal implant capable of being inserted translaterally.”

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The Court construes the term translateral spinal fusion implant to mean: “a spinal fusion implant

capable of being inserted translaterally.”

d) length

The next term at issue is length, appearing in claims 1, 35, and 61. Both parties offer

proposed constructions of the term. The Court tentatively found that length has a plain meaning to a

person of ordinary skill in the art and does not need to be construed. The Court AFFIRMS its

tentative ruling.

e) said implant having a length that is greater than one half the transverse width ofthe vertebrae

The next term at issue is said implant having a length that is greater than one half the

transverse width of the vertebrae, appearing in claims 1, 35, and 61. Medtronic offers a proposed

construction of a portion of the term: “transverse width of the vertebrae.” Medtronic also argues that

a person of ordinary skill in the art would understand how to select an implant as described in the

term. Nuvasive argues that the term is indefinite under 35 U.S.C. §112, para. 2 because it relies on

unknown variables. The Court tentatively found that the term is not indefinite, the portion of the

term constructed by Medtronic does not need to be construed, and that implants less than 26 mm in

length have not been disclaimed and are capable of meeting this limitation.

The burden is on NuVasive to prove by clear and convincing evidence that the term is

indefinite. NuVasive asserts that the structure of the implant (i.e., length and height) cannot be

determined until a particular person’s spine is selected, and the particular vertebrae on the spine are

selected. NuVasive argues that the term is indefinite because it requires the implant to be

determined by variables that are unknown, making it impossible to know whether a particular

implant infringes the patented invention until it is actually inserted in between a person’s vertebrae.

Medtronic asserts that a person of ordinary skill in the art would read the claim and understand how

to select an implant in conformance with the limitations described in the term as soon as a specific

person and specific vertebrae of the person are chosen for implantation.

Under 35 U.S.C. § 112, para. 2, the claims of a patent must “particularly point[ ] out and

distinctly claim[ ] the subject matter which the applicant regards as his invention.”

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The primary purpose of the definiteness requirement is to ensure that theclaims are written in such a way that they give notice to the public of the extentof the legal protection afforded by the patent, so that interested members of thepublic, e.g., competitors of the patent owner, can determine whether or not theyinfringe. That determination requires a construction of the claims according tothe familiar canons of claim construction.

All Dental Prodx, LLC v. Advantage Dental Prods., 309 F.3d 774, 779-80 (Fed. Cir. 2002) (citations

omitted). Therefore, a “definiteness inquiry focuses on whether those skilled in the art would

understand the scope of the claim when the claim is read in light of the rest of the specification.”

Union Pac. Resources v. Chesapeake Energy Corp., 236 F.3d 684, 692 (Fed. Cir. 2001) (citing

Orthokinetics, Inc. v. Safety Travel Chairs, Inc., 806 F.2d 1565, 1576 (Fed. Cir. 1986). If a claim

“remains insolubly ambiguous without a discernible meaning after all reasonable attempts at

construction,” it must be deemed indefinite. Metabolite Labs., Inc. v. Lab. Corp, of Am. Holdings,

370 F.3d 1354, 1366 (Fed. Cir. 2004).

During the claims construction hearing, Medtronic cited Howmedica Osteonics Corp v.

Tranquil Prospects, Ltd., 401 F.3d 1367 (Fed. Cir. 2005), to support its argument. The Court finds

Howmedica to be instructive in this case. The patents at issue in Howmedica claimed a method for

implantation of an “intramedullary prothesis” and an intramedullary prosthesis apparatus (an

apparatus that replaces the ball of the hip joint). Id. at 1367. Together the two patents claimed an

invention “that shapes the prosthesis to fit snugly inside the medullary canal.” The court found that

a dimensional term used in the claims of both patents, “transverse sectional dimension,” did not

render the patents indefinite. The court determined that a person of ordinary skill in the art would

understand that term in light of the intended use of the invention, the written description of the

invention, and the person of ordinary skill in the art’s knowledge of that portion of the human

anatomy. Id. at 1371-1372. Specifically, the court stated, in pertinent part:

[T]he term “transverse sectional dimensions” also need not specify percentagelimitations nor the locations along the prosthesis that the percentage mustsatisfy to constitute a proper dimensional fit. The patent clearly specifies that“the present invention is rooted in the recognition of the importance andcriticality of the stem’s transverse sectional dimensions, along the entire lengththereof, relative to the corresponding transverse sectional dimensions of themedullary canal ….”

Id. at 1373.

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The dimension term at issue here is similar to the term in Howmedica. Beyond the fact that

the term references dimensions of the invention vis-a-vis a person’s body part, as in Howmedica, a

person of ordinary skill in the art would be able to understand the bounds of the patent’s claims.

Contrary to NuVasive’s argument, the unknown variable of “vertebrae” does not render the term

indefinite, although it certainly impacts the breadth of the claim. However, “[m]erely claiming

broadly does not render a claim insolubly ambiguous, nor does it prevent the public from

understanding the scope of the patent.” See Ultimax Cement Mfg. Corp. v. CTS Cement Mfg. Corp.,

587 F.3d 1339, 1352 (Fed. Cir. 2009) (citing In re Gardner, 427 F.2d 786, 788, 57 C.C.P.A. 1207

(CCPA 1970) (“Breadth is not indefiniteness.”)).

Furthermore, “[a] claim is not indefinite merely because its scope is not ascertainable from

the face of the claims.” Amgen Inc. v. Hoechst Marion Roussel, Inc., 314 F.3d 1313, 1342 (Fed. Cir.

2003). If one having ordinary skill in the art is able to understand the claim after reading the claims

and specification, the claim is valid. See Energizer Holdings, Inc. v. Int’l Trade Comm’n, 435 F.3d

1366, 1370 (Fed. Cir. 2006). When considered within the context of the patent’s claims and

specification, the disputed term is not so indefinite as to render it “insolubly ambiguous.” The term

establishes the relationship between the dimensions of length and transverse width. When the term

is read together with the additional dimensions stated in claim 1, and a person of ordinary skill in the

art considers the shapes and the numeric distance ranges assigned to spinal regions referenced in

following dependent claim, the term is not indefinite based on its reference to “vertebrae.”

According to the Federal Circuit, a patentee is not required to define a claimed invention with

mathematical precision in order to comply with the definiteness requirement. Oakley, Inc. v.

Sunglass Hut Int’l, 316 F.3d 1331, 1341 (Fed. Cir. 2003) (citing In re Marosi, 710 F.2d 799,

802-803 (Fed. Cir. 1983)).

The Court AFFIRMS its tentative ruling and finds that the term said implant having a

length that is greater than one half the transverse width of the vertebrae is not indefinite. The

Court also AFFIRMS its tentative ruling and finds that the portion of the term constructed by

Medtronic, “transverse width of the vertebrae,” does not need to be construed, and that implants less

than 26 mm in length have not been disclaimed and are capable of meeting the term’s limitation.

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f) said length being substantially greater than the depth of the vertebrae

The next term at issue is said length being substantially greater than the depth of the

vertebrae, appearing in claims 1, 35, and 61. The Court tentatively found that this term is not

indefinite and that implants less than 26 mm in length have not been disclaimed and are capable of

meeting the term’s limitation. Medtronic offers a proposed construction of the term: “the implant is

sized to fit within substantially the full transverse width of the intervertebral space and cannot be

safely implanted from an anterior or posterior position.” The Court tentatively found that the term

has a plain meaning to a person of ordinary skill in the art and does not need to be construed.

As noted previously, the burden is on NuVasive to prove by clear and convincing evidence

that the term is indefinite. Based on the discussion and reasoning above, the Court AFFIRMS its

tentative ruling that the term said length being substantially greater than the depth of the

vertebrae is not indefinite. See, e.g.,Ecolab Inc. v. Envirochem, Inc., 264 F.3d 1358, 1367 (Fed.

Cir. 2001) (“‘ the term ‘substantially’ is a descriptive term commonly used in patent claims to ‘avoid

a strict numerical boundary to the specified parameter’”) (quoting Pall Corp. v. Micron Separations,

Inc., 66 F.3d 1211, 1217 (Fed. Cir. 1995). The Court also AFFIRMS its tentative ruling and finds

that the portion of the term constructed by Medtronic, “transverse width of the vertebrae,” does not

need to be construed, and that implants less than 26 mm in length have not been disclaimed and are

capable of meeting the term’s limitation.

g) a height for contacting each of the two adjacent vertebrae

The next term in dispute is a height for contacting each of the two adjacent vertebrae,

appearing in claims 1, 35, and 61. The Court tentatively found that this term is not indefinite and that

implants less than 26 mm in length have not been disclaimed and are capable of meeting the term’s

limitation. Neither party offered a proposed construction of the term, or any portion thereof, and the

Court finds that the term has plain meaning to a person of ordinary skill in the art. Once again the

Court relies on the same general analysis in section e, supra, to conclude that this term is not

indefinite. Accordingly, the Court AFFIRMS its tentative ruling that a height for contacting each

of the two adjacent vertebrae is not indefinite and that implants less than 26 mm in length have not

been disclaimed and are capable of meeting the term’s limitation.

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h) a plurality of openings capable of retaining fusion promoting materiali) a plurality of openings capable of retaining fusion promoting substances

The next two terms in dispute are sufficiently similar to be considered together. The terms in

dispute are a plurality of openings capable of retaining fusion promoting material, appearing in

claims 9 and 46, and a plurality of openings capable of retaining fusion promoting substances,

appearing in claim 61. The Court tentatively found these terms to be indefinite. Neither party

offered a proposed construction of either term, or any portion thereof, and the Court found that the

terms have plain meaning to a person of ordinary skill in the art.

At the claims construction hearing, the Court advised the parties of its tentative rulings to

assist the parties in determining which patents/claims/terms to focus on during the hearing. With

respect to these terms, the Court noted that it had some difficulty with the word “openings.”

Medtronic agreed with the Court that an “opening” could be one of several types, i.e. an indentation

or dimple on the surface of the implant, or a hollow tunnel within the implant. Medtronic directed

the Court to the patent at 10:25-31, wherein the patent describes a spinal fusion implant, having a

plurality of openings, those openings passing through the entire implant or having closed bottoms,

either of which for holding fusion promoting materials. NuVasive countered this position by

asserting that an “opening” does not retain anything, as the two terms require an opening to do. See

Transcript of Hearing, p.27, ll.14-18. Rather, counsel argued that the structure of the implant itself

retained the material. Id.

At one point during the claims construction hearing, counsel for Medtronic framed the issue

this way: “the issue is does a person of ordinary skill in the art understand the concept of an opening

and can that person of ordinary skill in the art determine whether or not that opening meets the claim

limitation? That is, holding bone growth promoting substance?” See Transcript of Hearing, p.18,

ll.8-12. Upon consideration of the oral arguments of counsel, having reviewed the submissions by

the parties, the Court believes the answer to Medtronic’s query is yes. As such, the Court

DECLINES to affirm its tentative ruling and finds that the terms a plurality of openings capable

of retaining fusion promoting material and a plurality of openings capable of retaining fusion

promoting substances are not indefinite.

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j) engagement means

The next term in dispute is engagement means, appearing in claims 10 and 47. The Court

tentatively found that the term should be construed pursuant to 35 U.S.C. § 112, para.6, and that the

function is “engaging instrumentation for the insertion of said implant.” In so ruling, the Court

adopted the parties’ proposed construction of the term. The Court further found that the patent does

not disclose a corresponding structure for performing the function, rendering the term indefinite

pursuant to 35 U.S.C. § 112, para. 2, and claims 10 and 47 invalid. In so ruling, the Court agreed

with NuVasive’s position on the issue.

The Federal Circuit has explained that “Section 112, paragraph 6 [of Title 35 of the United

States Code,] allows a patentee to recite a function to be performed as a claim limitation rather than

reciting structure or materials for performing that function.” Omega Eng’g, Inc. v. Raytek Corp.,

334 F.3d 1314, 1321 (Fed. Cir. 2003). “Means-plus-function claiming applies only to purely

functional limitations that do not provide the structure that performs the recited function.” Phillips

v. AWH Corp., 415 F.3d 1303, 1311 (Fed. Cir. 2005). In construing means-plus function terms,

courts first “identify the claimed function, staying true to the claim language and the limitations

expressly recited by the claims;” then, courts must “ascertain the corresponding structures in the

written description that perform those functions.” Id. The party seeking to invalidate a claim under

35 U.S.C. § 112, para. 2 as indefinite must show by clear and convincing evidence that one skilled in

the art would not understand the scope of the claim when read in light of the specification.

Intellectual Prop. Dev., Inc. v. UA-Columbia Cablevision of Westchester, Inc., 336 F.3d 1308, 1319

(Fed. Cir. 2003).

There are two requirements for structure(s) to be considered “corresponding.” First, the

structure(s) must actually perform the claimed function. Cardiac Pacemakers, Inc. v. St. Jude

Medical, Inc., 296 F.3d 1106, 1113, 1119 (Fed. Cir. 2002). Second, the specification or the

prosecution history must clearly link or associate the structure(s) with performance of the claimed

function. Id. at 1113. The parties seem to agree that there is a reference in the specification to

engagement means at 8:14-17 (“The spinal fusion implant 200 has an engagement means at one

end for engaging a driver instrument for intimately engaging and binding the implant 200 and the

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driver instrument together.”). This reference describes Figure 8, which shows what Medtronic refers

to as a “slot” at one end of the implant. Medtronic argues that Figure 8 sufficiently discloses the

corresponding structure for engagement means. Medtronic also points to 5:53-57 (“The spinal

fusion implant 100 has a removable cap 118 at one end which provides access to the internal

chamber 114 and has an insertion end 120 adapted to engage insertion instrumentation.”). This

reference describes Figure 1, which shows an “insertion end” (one end of the implant) that once

again has a “slot.”

NuVasive argues that this “slot” is not described or mentioned in the specification, rather, it

is shown in two of the drawings but never identified. Therefore, NuVasive asserts that the “slot”

does not correspond to the function. Medtronic counters that the “slot” is identified in Figure 1 by

the number 120. However, the Court agrees with NuVasive that 120 identifies the “insertion end” of

the implant, not a corresponding structure for “engaging instrumentation for the insertion of said

implant.”

The Court finds that the specification does not clearly link any structure to the performance

of the function, “engaging insertion instrumentation.” A person of ordinary skill in the art may be

able to envision various ways in which the “insertion end” of the implant could be designed to

perform the function. However, this does not change the fact that no corresponding structure is

disclosed in the patent itself. The inquiry under 35 U.S.C. § 112, para. 2 asks first “whether

structure is described in specification, and, if so, whether one skilled in the art would identify the

structure from that description.” Atmel Corp. v. Information Storage Devices, 198 F.2d 1374, 1381

(Fed. Cir. 1999). Because no structure corresponding to the specified function is described,

NuVasive has shown by clear and convincing evidence that the ‘973 Patent fails to overcome this

first hurdle.

Accordingly, the Court AFFIRMS its tentative ruling and finds that the term engagement

means should be construed pursuant to 35 U.S.C. § 112, para. 6 of the Patent Act, and found

indefinite pursuant to Section 112, para. 2. The Court further finds that the failure of the ‘973 Patent

to disclose a structure corresponding to the engagement means function renders claims 10 and 47

of indefinite scope in violation of § 112, ¶ 2 of the Patent Act.

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k) internal chamber

The next term in dispute is internal chamber, appearing in claims 13, 15, 16, 17, 50, 52, 53,

and 54. The Court tentatively found that Medtronic offered the correct proposed construction of the

term, and as such, the Court construed the term internal chamber to mean: “a space or

compartment inside the implant.” Having reviewed the submissions as well as the intrinsic

evidence, the Court AFFIRMS its tentative ruling.

2. Medtronic U.S. Patent No. 6,592,586: Single-Lock Anterior Cervical Plating System

The invention embodied in the ‘586 Patent once again relates to spinal fusion, and consists of

a plate and locking screw system that is used to keep two or more vertebrae together in order to align

and maintain the position of the vertebrae during spinal fusion surgery. The invention claims to be

an improvement over the prior art because it positions the bone screws in such a way that they are

more secure once screwed into the vertebra. Once the screws are in place, the invention also

provides an improved method for keeping the screws locked to the plate itself. Together, these two

improvements successfully keep everything tight and locked in place, i.e. preventing the screws

from “backing out” of the bone.

The parties dispute the construction of a single term in the ‘586 Patent, rotational axis,

appearing in claims 15, 85, 155, and 190. The Court tentatively found that neither party offered an

appropriate proposed construction of the term. The Court faulted NuVasive’s construction for

importing an additional limitation not supported by the intrinsic evidence. The Court found that

Medtronic’s construction mapped the claim language too closely stripping the term of any meaning.

The Court construed the term to mean: “the axis about which the locking element is able to rotate.”

The Court has reviewed the submissions of the parties as well as the intrinsic evidence and

AFFIRMS its tentative ruling.

3. Medtronic U.S. Patent No. 6,945,933: Instruments and Methods for Minimally InvasiveTissue Retraction and Surgery

The invention embodied in the ‘933 Patent is part method/part device that allows a spinal

surgeon to access a surgical site using a minimally invasive process. The invention includes a

“retractor.” In its closed position, the retractor can be inserted, creating a “working channel” to the

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surgical site by moving tissue out of the way. Surgical instruments can be inserted directly into the

working channel. The retractor can be expanded or pivoted if necessary during the surgery in order

to allow a wider working channel if the instruments being used by the surgeon require one. The

retractor can also be used with a “separation instrument” in order to assist the surgeon in expanding

or pivoting the retractor as previously described.

a) A tissue retractor for percutaneous surgery in a patient/A kit for use inpercutaneous surgery

b) percutaneous surgery

The parties dispute whether the preamble to claims 1 and 24 (“a tissue retractor for

percutaneous surgery in a patient”) and the preamble to claim 56 (“a kit for use in percutaneous

surgery”) limit those claims, or whether the preambles serve only as statements of intended use. The

Court tentatively found that the preambles are statements of intended use and therefore do not limit

the claims, agreeing with NuVasive’s proposed construction. In so finding, the Court also found

that the term percutaneous surgery does not need to be construed because it only appears in these

preambles. Medtronic asserts that the preambles recite structure (i.e., the tissue retractor and the kit)

and “breathe life into the claims.” The parties do not dispute that “tissue retractor” and “kit” recite

structure, and the Court agrees. NuVasive takes issue with the portion of the preambles that it

asserts only states an intended use, “for percutaneous surgery.”

As the Court noted above in section I, subsection 1(a), a claim preamble is limiting if “it

recites essential structure or steps, or if it is necessary to give ‘life, meaning, and vitality’ to the

claim.” Catalina Mktg., Int’l, 289 F.3d at 808 (quoting Pitney Bowes, Inc., 182 F.3d at 1305.).

However, as the Federal Circuit recently noted, “the mere fact that a structural term in the preamble

is part of the claim does not mean that the preamble’s statement of purpose or other description is

also part of the claim.” Marrin v. Griffin, 2010 U.S. App. LEXIS 5789 (Fed. Cir. Mar. 22, 2010).

Such is the case here. “For percutaneous surgery” is a statement of purpose or intended use of the

claimed apparatus. The Court finds that “for percutaneous surgery” is not a structural limitation. If

the phrase is deleted from the preamble, the structural definitions of tissue retractor and kit are not

impacted. The claims as a whole “define[] a structurally complete invention.” Catalina Mktg., Int’l,

289 F.3d at 810. “For percutaneous surgery” states an intended use of the retractor, and a review of

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the patent’s prosecution history indicates that the inventor did not rely on this intended use to

distinguish the invention over the prior art; rather, the arguments made in response to the

communications from the examiner were structural in nature.

Accordingly, the Court AFFIRMS its tentative ruling and finds that the disputed preamble

language, “for percutaneous surgery,” does not limit claims 1, 24, or 56. “To hold otherwise would

effectively impose a method limitation on an apparatus claim without justification.” Catalina Mktg.

Int’l, 289 F.3d at 810. The term percutaneous surgery does not need to be construed.

c) working channel

The next term in dispute is working channel, appearing in claims 1, 24, 56, 63, and 67. The

Court tentatively found that the term does not need to be construed, as a person of ordinary skill in

the art would understand the plain meaning of the term within the context of the claims. Medtronic

offered the following proposed construction: “a passageway through which work is performed at a

surgical site.”

When considering this term, the Court found Medtronic’s construction problematic because

of the additional language “performed at a surgical site.” The Court initially determined that this

phrase suffers from the same defect as the above-cited preamble language, in so far as it is a

statement of intended use. Upon further consideration, the Court continues to find Medtronic’s

proposed construction of the term to be too narrow. If adopted, Medtronic’s construction would

limit the use of the apparatus to one specific place, a surgical site, otherwise its construction of the

term would be nonsensical. The Court finds that a person of ordinary skill in the art would not read

the claims of the ‘933 Patent and conclude that the invention can only be used at a surgical site.

Again, as noted above, the additional language in Medtronic’s construction would “effectively

impose a method limitation on an apparatus claim without justification.”

The invention is the retractor; using the invention to assist a physician while performing

surgery was obviously the primary intention of the inventor. However, there is no structural aspect

of the retractor that requires this use in order for the retractor to function. Accordingly, the Court

AFFIRMS its tentative ruling, rejects Medtronic’s proposed construction, and finds that the term

working channel has a plain meaning to a person of ordinary skill in the art and need not be

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construed.

d) said working channel being enclosed by said first portion and said secondportion (claim 1)

e) said working channel has a cross-section circumscribed by said first and secondportions (claim 24)

f) a first portion and a second portion substantially circumscribing said workingchannel (claim 56)

g) substantially enclosed (claim 63)

The next four terms in dispute may be considered together for the present purpose. The

parties focus their dispute on the words “enclosed,” “circumscribed,” “substantially enclosed,” and

“substantially circumscribed.” The Court tentatively found that none of these terms need to be

construed, as all four had plain meanings to a person of ordinary skill in the art reading the claims of

the patent. Medtronic proposed that the terms do not need to be construed. NuVasive disagreed,

suggesting that the terms must be construed to mean that the edges of the retractor’s “first portion”

and “second portion” are “not spaced apart from one another” and “there are no gaps” between the

first and second portion, i.e. the blades of the retractor.

During the claims construction hearing, NuVasive brought to the Court’s attention the

parties’ original agreement on a proposed construction of these terms that included NuVasive’s

limiting language. See Transcript of Hearing, p.79, ll:18-25. NuVasive pointed to the ‘933 Patent’s

prosecution history to support the construction. According to NuVasive, in order to distinguish his

retractor from the prior art, the inventor repeatedly emphasized that when in a closed position, his

retractor blades were flush with one another, with no gap or space between them, unlike the

predecessor retractors whose blades never completely closed and always had a space or gap left in

between them. This being the case, NuVasive argued that the inventor disclaimed any construction

of the four above-referenced claims wherein the retractor blades had a space or gap left between

them when in a closed position.

The Court has reviewed the prosecution history of the ‘933 Patent. More importantly, the

Court has reconsidered the construction of these terms in light of the claims and specification. The

Court DECLINES to affirm its tentative ruling. The claims themselves illuminate the intended

meaning of these terms. For instance, claim 24 begins by stating: “A tissue retractor for

percutaneous surgery in a patient, comprising: a first portion and a second portion adjacent said first

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portion . . .” The word “adjacent” is generally understood to mean having a common boundary or

edge, in other words, touching. Presumably the inventor carefully chose his claim language, and use

of the word “adjacent” was meant to convey a structural aspect of the claimed invention. By

indicating that the portions of the retractor would be adjacent, the inventor claims an improvement

over the prior art which is supported by the patent’s prosecution history.

Accordingly, the Court construes these four terms as follows:

• said working channel being enclosed by said first portion and said second

portion means: “said working channel being enclosed by said first portion and said

second portion such that the edges of the first and second portions are not spaced

apart from one another.”

• said working channel has a cross-section circumscribed by said first and second

portions means: “said working channel has a cross-section circumscribed by said

first and second portions such that the edges of the first and second portions are not

spaced apart from one another.”

• a first portion and a second portion substantially circumscribing said working

channel means: “a first portion and a second portion substantially circumscribing

said working channel such that the edges of the first and second portions are not

spaced apart from one another.”

• substantially enclosed means: “enclosed such that there are no gaps between the first

and second portions of the retractor.”

h) laterally moving each of said first and second portions away from one another

The next term in dispute is laterally moving each of said first and second portions away

from one another, appearing in claim 1. The Court tentatively adopted NuVasive’s proposed

construction, and as such, found that the term should be construed to mean: “moving each of the first

and second portions away from one another in a direction that is transverse to the central axis of the

working channel.” Medtronic offered the following proposed construction: “moving apart the

entirety of each of said first and second portions in a direction that is transverse to the central axis.”

The dispute centers on Medtronic’s addition of the word “entirety.” NuVasive argues that the patent

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specification does not limit the claim in this manner. Having reviewed the intrinsic evidence, the

Court finds that the structure of the apparatus as specified by the patent claims obviates the need for

Medtronic’s proposed additional language. As such, the Court AFFIRMS its tentative ruling and

construes the term laterally moving each of said first and second portions away from one

another to mean: “moving each of the first and second portions away from one another in a

direction that is transverse to the central axis of the working channel.”

i) a lateral separator for laterally separating said first and second portions

The next term in dispute is a lateral separator for laterally separating said first and

second portions, appearing in claim 20. The Court tentatively found that the term should be

construed to mean: “a component that is able to move the first and second portions in a direction that

is transverse to the central axis of the working channel.” The Court AFFIRMS its tentative ruling.

j) each of said first and said [second] portions are laterally separable . . .relative toone another

The next term in dispute is each of said first and said [second] portions are laterally

separable . . . relative to one another, appearing in claim 24. The Court tentatively found that the

term should be construed to mean: “each of the first and second portions are able to move apart from

one another in a direction transverse to the central axis of the working channel.” The Court

AFFIRMS its tentative ruling.

i) a lateral separator operable to laterally separate each of said first portion andsaid second portion from the other of said first portion and said second portion

The next term in dispute is a lateral separator operable to laterally separate each of said

first portion and said second portion from the other of said first portion and said second

portion, appearing in claim 56. The Court tentatively found that the term should be construed to

mean: “a component that is able to move apart from one another each of the first portion and the

second portion in a direction transverse to the central axis of the working channel.” The Court

AFFIRMS its tentative ruling.

j) laterally separating . . . each one of first and second portions of the retractorrelative to the other of the first and second portions of the retractor

The next term in dispute is laterally separating . . . each one of first and second portions

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of the retractor relative to the other of the first and second portions of the retractor, appearing

in claim 63. The Court tentatively found that the term should be construed to mean: “moving apart

each one of the first and second portions of the retractor in a direction that is transverse to the central

axis of the working channel.” The Court AFFIRMS its tentative ruling.

k) simultaneously laterally separating . . . the first and second portions of theretractor

The next term in dispute is simultaneously laterally separating . . . the first and second

portions of the retractor, appearing in claim 67. The Court construes the term consistently with

claim 63 to mean: “moving apart the first and second portions of the retractor in a direction that is

transverse to the central axis of the working channel.”

l) engageable

The next term in dispute is engageable, appearing in claims 20 and 56. The Court

tentatively found that the term should be construed to mean: “capable of being fitted together with or

connected to.” The Court AFFIRMS its tentative ruling.

m) removably engageable to

The next term in dispute is removably engageable to, appearing in claims 33 and 35. The

Court tentatively found that the term should be construed to mean: “capable of fitting together with

or connecting to or being removed from.” The Court AFFIRMS its tentative ruling.

n) pivoting each of said distal ends of said first and second portions (claim 1)o) pivoting said first and second portions (claim 20)p) pivotable relative to one another (claim 24)q) pivot each of said first portion and second portion (claim 56)r) pivoting each one of first and second portions of the retractor (claim 63)

The above five terms in dispute may be considered together for the present purpose. The

dispute with respect to these terms is whether they have a plain meaning to a person of ordinary skill

in the art, as NuVasive urges, or whether they need to be construed in order to clarify what is meant

by “pivot” and “pivoting.” The Court tentatively agreed with NuVasive that the terms do not need

to be construed. Medtronic asserts that the terms should be construed in the context of the

specification, such that pivot means that the distal ends of the retractor blades are further apart than

the proximal ends.

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During the claims construction hearing, counsel for Medtronic focused on the fact that the

claims anticipate two distinct types of movement. See Transcript of Hearing, p.74, ll.3-21. The

retractor blades are able to move “laterally,” which as noted above has been construed to mean

“transverse to the central axis of the working channel.” The retractor blades are also able “pivot,”

such that the proximal ends of the blades remain close together, while the distal ends move apart

from one another. The capability of the retractor to move both ways allows it to enlarge the

“working channel” in two respects. When the blades laterally separate, the entire length of the

working channel becomes larger (wider, bigger). When the blades pivot or rotate, the distal end of

the working channel becomes larger (wider, bigger) while the proximal end remains the same size.

NuVasive recognizes that some of the preferred embodiments demonstrate this result.

However, NuVasive argues that the claim language does not support Medtronic’s proposed narrow

construction, and as such, “pivot” should be given its plain meaning to a person of ordinary skill in

the art who should be able to distinguish pivoting from laterally separating without importing

additional meaning into the claim terms. The Court agrees with NuVasive, and therefore finds no

basis upon which to deviate from its tentative conclusion that the terms in dispute do not need to be

construed. Accordingly, the Court AFFIRMS its tentative ruling.

4. Nuvasive U.S. Patent No. 7,470,236: Electromyography System

The invention embodied in the ‘236 Patent is a method for detecting and monitoring the

proximity of a patient’s nerves during spinal surgery, i.e., so the surgeon is less likely to thrust a

probe or knife directly into a patient’s nerve. This patent teaches a method using an electrical

stimulus signal that can detect a neuromuscular response in the patient, locating the spinal nerve and

alerting the surgeon. This claims to be an improvement over previous methods because the signal

immediately stops when it hits on a response, whereas in other methods the signal keeps going.

a) stimulus signal

The first term in dispute is stimulus signal, appearing in claims 1, 2, 4-6, and 11. Both

parties submit that the term should be given its plain meaning to a person of ordinary skill in the art,

but disagree as to what a person of ordinary skill in the art would understand the plain meaning to

be. The Court tentatively adopted NuVasive’s proposed construction and found that the term’s plain

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meaning to a person of ordinary skill in the art is “an electrical signal for eliciting a neuromuscular

response.” Medtronic proposed that a person of ordinary skill in the art would understand the term

to mean “signal that can stimulate.” The key difference in this proposal is the omission of the word

“electrical” and of the phrase “for eliciting a neuromuscular response.”

Considering the term in the context of the claims in which it appears supports the Court’s

tentative ruling. The term stimulus signal is described in claims 1 and 2 in relation to the electrode

which emits the (electrical) signal. Claim 4 describes an “electrical stimulus signal.” The patent

teaches that the invention relates to electromyography. The claimed method uses electricity to elicit

a neuromuscular response, which is consistent with the invention’s relation to the field of

electromyography. Therefore, having reviewed the intrinsic evidence and the submissions of the

parties, the Court AFFIRMS its tentative ruling and finds that a person of ordinary skill in the art

would understand the plain meaning of stimulus signal to be “an electrical signal for eliciting a

neuromuscular response.”

b) stopping the emission of said stimulus signal immediately after saidpredetermined neuromuscular response is detected

The second term in dispute is stopping the emission of said stimulus signal immediately

after said predetermined neuromuscular response is detected, appearing in claim 1. The Court

tentatively found that this term has a plain meaning to a person of ordinary skill in the art and does

not need to be construed. The Court AFFIRMS its tentative ruling.

CONCLUSION

For the reasons stated above, the disputed terms of United States Patent Nos. 5,860,973;

6,945,933; 6,592,586; and 7,470,236 are construed as set forth in this Order.

IT IS SO ORDERED.

DATED: April 1, 2010

Hon. Michael M. AnelloUnited States District Judge