4-6 Claim Construction Order
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Transcript of 4-6 Claim Construction Order
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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